Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify Class E airspace to support IFR operations at Yerington Municipal Airport, Yerington, NV.

The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.

The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.

Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

An electronic copy of this document may be downloaded through the internet at www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at www.faa.gov/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Operations office (see ADDRESSES section for address, phone number, and hours of operations). An informal docket may also be examined during normal business hours at the office at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198.

Class E5 airspace designations are published in paragraph 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. These updates would be published in the next update to FAA Order JO 7400.11. That order is publicly available as listed in the ADDRESSES section of this document.

FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

Yerington Municipal Airport currently has Class E airspace extending upward from 11,000 feet mean sea level within 10.4 miles southwest and 7 miles northeast of the Mustang very high frequency omni-directional range/tactical air navigation (VORTAC) 135° radial, extending from 9.1 miles northwest to 18 miles southeast of the intersection of the Mustang VORTAC 135° radial and the Lovelock VORTAC 197° radial, excluding the airspace within Federal Airways. This airspace no longer serves a purpose and should be redesigned to appropriately support IFR operations at Yerington Municipal Airport, Yerington, NV.

The FAA is proposing an amendment to 14 CFR part 71 to modify the Class E airspace area extending upward from 700 feet or more from the surface of the earth at Yerington Municipal Airport, Yerington, NV, to support the airport's transition from VFR to IFR operations.

Class E airspace area should be modified to extend upward from 700 feet above the surface within a 5.2-mile radius of the airport, within 5.2 miles each side of the airport's 065° bearing extending from the 5.2-mile radius to 8.9 miles northeast of the airport, and within 3 miles each side of the airport's 184° bearing, extending from the 5.2-mile radius to 12.7 miles south of the airport. The proposed airspace would accommodate IFR arrival operations descending through 1,500 feet above the surface and departing IFR operations until reaching 1,200 feet above the surface.

Additionally, line four of the airport's legal description includes references to the Mustang and Lovelock VORTACs that are no longer needed to describe the airspace and should be removed. The Yerington Airport Reference Point should be added to the airspace description in their place.

The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” prior to any FAA final regulatory action.

In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend the airway structure as necessary to preserve the safe and efficient flow of air traffic within the National Airspace System.

The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.

The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.

Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

An electronic copy of this document may be downloaded through the internet at www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at www.faa.gov/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Operations office (see ADDRESSES section for address, phone number, and hours of operations). An informal docket may also be examined during normal business hours at the office of the Western Service Center, Federal Aviation Administration, 2200 South 216th St., Des Moines, WA 98198.

Alaskan VOR Federal Airways are published in paragraph 6010 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. These updates would be published in the next update to FAA Order JO 7400.11. That order is publicly available as listed in the ADDRESSES section of this document.

FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

In 2003, Congress enacted the Vision 100-Century of Aviation Reauthorization Act (Pub. L. 108-176), which established a joint planning and development office in the FAA to manage the work related to the Next Generation Air Transportation System (NextGen). Today, NextGen is an ongoing FAA-led modernization of the nation's air transportation system to make flying safer, more efficient, and more predictable.

In support of NextGen, this proposal is part of an ongoing, large, and comprehensive T-route modernization project in the state of Alaska. The project mission statement states: “To modernize Alaska's Air Traffic Service route structure using satellite-based navigation development of new T-routes and optimization of existing T-routes will enhance safety, increase efficiency and access, and will provide en route continuity that is not subject to the restrictions associated with ground-based airway navigation.”

As part of this initiative, the Ambler NDB is scheduled to be decommissioned. As a result, a portion of Alaskan V-477 will become unusable. This airspace action proposes to amend the Alaskan V-477 by revoking the portion of the airway that relies on the Ambler NDB.

The FAA is proposing an amendment to 14 CFR part 71 to amend Alaskan VOR Federal Airway V-477 in the vicinity of Ambler, AK due to the pending decommissioning of the Ambler NDB.

V-477: V-477 currently extends between the Galena, AK, VOR/DME, Huslia, AK, VOR/DME, Selawik, AK, VOR/Distance Measuring Equipment (DME), and the Ambler, AK, NDB. Due to the pending decommissioning of the Ambler NDB, the portion of V-477 between the Selawik VOR/DME and the Ambler NDB will become unusable. As amended, the Alaskan V-477 would extend between the Galena VOR/DME, Huslia VOR/DME, and the Selawik VOR/DME.

The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

FDA is proposing to ban ESDs intended for self-injurious behavior (SIB) or aggressive behavior (AB) pursuant to the Agency's authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) after determining that the devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. FDA previously issued a final rule in 2020 banning these devices (2020 Final Rule) (85 FR 13312, March 6, 2020), which was vacated by the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) on July 6, 2021. The D.C. Circuit opined that FDA's authority to ban devices intended for human use under the FD&C Act, as it existed at the time, did not permit FDA to ban a device for some (but not all) of its intended uses. Following the D.C. Circuit's decision, Congress amended the FD&C Act to expressly state that FDA's authority to ban a device includes the authority to ban some intended uses of a device, even if the Agency does not seek to ban it for all intended uses. The amendment to the FD&C Act thereby authorizes FDA to issue a ban that applies to specific intended uses, such as the previous ban on ESDs for self-injurious and aggressive behavior. This proposed rule, if finalized, would reestablish the ban now that it is clear that FDA has the authority to do so.

ESDs are aversive conditioning devices that apply a noxious electrical stimulus (a shock) to a person's skin to condition behavior to reduce or cease SIB and AB. SIB and AB frequently manifest in the same individual, and people with intellectual or developmental disabilities exhibit these behaviors at disproportionately high rates. Notably, some people with intellectual or developmental disabilities who exhibit SIB and AB have difficulty communicating and cannot make their own treatment decisions because of such disabilities, meaning they are part of a vulnerable population.

In issuing the 2020 Final Rule, FDA determined that the medical literature shows that ESDs for SIB or AB pose a number of psychological harms including depression, post-traumatic stress disorder (PTSD), anxiety, fear, panic, substitution of other negative behaviors, worsening of underlying symptoms, and learned helplessness (becoming unable or unwilling to respond in any way to the ESD); and the devices present the physical risks of pain, skin burns, and tissue damage. We also found that other sources, such as experts in the field, State agencies that regulate ESD use, and records from the only facility that has recently manufactured and is currently using ESDs for SIB or AB, indicate that ESDs pose additional risks such as suicidality, chronic stress, acute stress disorder, neuropathy, withdrawal, nightmares, flashbacks of panic and rage, hypervigilance, insensitivity to fatigue or pain, changes in sleep patterns, loss of interest, difficulty concentrating, and injuries from falling. We also determined that state-of-the-art treatments for this patient population have evolved away from ones that include ESD use and toward various positive behavioral treatments, sometimes combined with pharmacological treatments. Although the available data and information suggest that some individuals subject to ESDs exhibit an immediate reduction or cessation of the targeted behavior, the available evidence has not established a durable long-term conditioning effect or an overall favorable benefit-risk profile for ESDs for SIB and AB.

For this proposed rule, FDA has determined that there have been no material changes regarding these topics in the available literature that impact our findings and assessments in the 2020 Final Rule. Accordingly, FDA has determined on the basis of all available data and information that ESDs for SIB or AB present an unreasonable and substantial risk of illness or injury and that such risk cannot be corrected or eliminated by labeling or by a change in labeling. FDA is issuing this proposed rule to give notice of FDA's determination and give interested persons an opportunity to comment on the determination and FDA's proposal to ban ESDs for SIB and AB. All references to section numbers are references to section numbers in this proposed rule unless otherwise specified.

We are proposing to amend part 895 (21 CFR part 895) to designate ESDs for SIB or AB as banned devices. If this proposed rule is finalized as proposed, the ban would include only aversive conditioning devices intended to apply a noxious electrical stimulus to a person's skin to reduce or cease aggressive or self-injurious behavior. The proposed ban would apply to devices already in commercial distribution and devices already in use by the ultimate (end) user, as well as devices to be sold or commercially distributed in the future. A banned device is an adulterated device, subject to enforcement action. Additionally, a device that is banned for one or more intended uses is not legally marketed within the meaning of section 1006 of the FD&C Act (21 U.S.C. 396) when intended for such use or uses. The ban would not, however, prevent further study of such devices pursuant to an investigational device exemption if the requirements for such an exemption are met. We also are proposing conforming edits to 21 CFR part 882 to clarify that ESDs are banned when used to reduce or cease SIB or AB.

We are proposing to issue this rule pursuant to FDA's authority to ban devices intended for human use, as recently amended by Congress. We also are proposing to issue this rule under the authority to issue regulations for the efficient enforcement of the FD&C Act.

This proposed rule, if finalized, would reestablish the ban of ESDs for SIB or AB. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling or a change in labeling. The proposed rule, if finalized, would apply to both new devices and devices already in distribution and use. Unquantified benefits would include reduction in physical and psychological adverse effects from using ESDs on individuals, as well as benefits to society in terms of protecting vulnerable populations. We quantify costs for the case in which the affected individuals might move to another facility and costs to the affected entities, who use the device on such individuals, to read and understand the rule. We estimate that the annualized costs over 10 years would range from $0.00 million to $9.17 million with a primary estimate of $4.59 million at both a 7 percent and a 3 percent discount rate.

FDA is proposing to ban certain devices that apply a noxious electrical stimulus to attempt to reduce or stop undesirable, injurious behaviors frequently manifested by vulnerable people. Specifically, this rulemaking would ban ESDs for SIB or AB because the devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling or a change in labeling. This is the second ban on these devices we are undertaking to protect and promote the public health. As we will explain in more detail, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) vacated the first ban.

ESDs for SIB or AB give people an often-painful electric shock to try to make them stop behaving in ways that are harmful and/or dangerous and that are often related to other underlying intellectual or developmental disabilities. More specifically, ESDs are a type of aversive conditioning device that apply a noxious electrical stimulus (the shock) to a person's skin in an attempt to reduce or cease self-injurious or aggressive behaviors. SIB commonly includes head-banging, hand-biting, excessive scratching, and picking of the skin. However, SIB can be more extreme and result in bleeding; broken, even protruding bones; blindness from eye-gouging or poking; other permanent tissue damage; or injuries from swallowing dangerous objects or substances. AB can involve repeated physical assaults and can be a danger to the individual, others, or property. In this proposed rule, like much of the scientific literature, we discuss SIB and AB in tandem and use the phrase “SIB or AB” to refer to SIB, AB, or both. A more detailed discussion of SIB and AB and intellectual or developmental disabilities as they relate to individuals with SIB or AB can be found in section I.B of the previous proposed rule to ban these devices (2016 Proposed Rule) (81 FR 24386 at 24389).

ESDs that are subject to this proposed ban are intended to reduce SIB or AB according to the principle of aversive conditioning. Aversive conditioning pairs a noxious stimulus (such as, here, a noxious electric shock delivered to an individual's skin) with a target behavior; the goal is that the individual eventually associates the noxious stimulus with the behavior. Pairing a target behavior with shocks from an ESD is intended to affect behavior in two ways: by interrupting the target behavior as an immediate response to the stimulus—for example, in response to pain—and, over time, through a conditioned reduction in the target behavior if the person learns to associate the shock with the target behavior (and can learn to control the behavior). Associating the unwanted behavior with the shock is intended to decrease the frequency of the behavior or stop it altogether.

However, as explained here, ESDs pose a number of serious risks and have not been shown to be effective, and modern treatments for SIB or AB have been generally successful without involving the use of ESDs. State-of-the-art treatments instead include conducting a functional behavioral assessment to determine the causes and triggers of self-injury or aggression, then using that information to design a plan with supportive approaches, consisting of multiple elements, to modify the behavior. In some cases, pharmacotherapy is an appropriate element of a treatment plan, depending on the specific patient. These approaches have generally been successful, even for some of the most difficult cases. The use of ESDs was mostly abandoned decades ago, in part because the shocks can be painful or very painful for the recipients. Only one facility in the United States still applies these devices to individuals.

Although in 2018 a Massachusetts court found, for the purpose of considering whether to lift a consent decree, that there was no professional consensus as to whether ESDs are part of standard of care for treating individuals with intellectual and developmental disabilities, 1 the professional consensus regarding the accepted standard of care and such use of ESDs is not an issue in this rulemaking (see discussion in the 2020 Final Rule, 85 FR 13312 at 13314 through 13315). Rather, to ban a device under section 516 of the FD&C Act (21 U.S.C. 360f), FDA must determine the device presents an “unreasonable and substantial risk of illness or injury.” In making this determination, FDA analyzes whether the risks the device poses to individuals are important, material, or significant in relation to its benefits to the public health, and FDA compares those risks and benefits to the risks and benefits posed by alternative treatments being used in current medical practice (which relates to what FDA refers to as “the state of the art”) (85 FR 13312 at 13315; 81 FR 24386 at 24388). The purpose of considering the alternatives used in current medical practice to treat a particular patient population is to assess and compare the risks and benefits of those alternatives to the risks and benefits of the device that is the subject of the ban, not to determine whether the device that is the subject of the ban is part of the standard of care or state of the art. For these reasons, as stated in the 2020 Final Rule, whether punishment, contingent shock, or ESDs are within the standard of care or state of the art is not an issue in this rulemaking (85 FR 13312 at 13341). In sum, the court's decision has no legal or scientific bearing on this proposed ban.

This rulemaking would protect and promote the public health by banning ESDs for SIB or AB, which would prevent this patient population from being subjected to a device that poses a substantial and unreasonable risk of illness or injury. As we explained in the previous rulemaking to ban ESDs for SIB and AB, people who manifest SIB or AB often have intellectual and developmental disabilities including, but not limited to, autism spectrum disorder, Down syndrome, or Tourette syndrome, as well as other cognitive or psychiatric disorders and severe intellectual impairment (including a broad range of intellectual measures) (see, e.g., 81 FR 24386 at 24389). Notably, some people with such intellectual and developmental disabilities may have difficulty communicating and may not be able to make their own treatment decisions because of such disabilities (see, e.g., 85 FR 13312 at 13329). This, among other reasons, means that many people who exhibit SIB or AB constitute a vulnerable population. For people who manifest SIB or AB, ESDs intended for those conditions present a substantial and unreasonable risk of illness or injury that cannot be corrected or eliminated by labeling or a change in labeling. As such, a ban on these devices for these intended uses is warranted.

As discussed in section IV below, section 516(a) of the FD&C Act authorizes FDA to ban a device for one or more intended uses, by regulation, if we find, on the basis of all available data and information, that such a device presents substantial deception or an unreasonable and substantial risk of illness or injury. Accordingly, based on the serious risks posed by ESDs for SIB or AB, the inadequacy of data to support their effectiveness, and the positive benefit-risk profiles of the state-of-the-art alternatives for the treatment of SIB or AB, FDA has determined that ESDs present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. The proposed rule would apply to devices already in distribution and use, as well as to future sale and distribution of these devices. The purpose of this notice is to seek comments on FDA's proposal to ban ESDs used for SIB or AB and comments on any other associated issues. Section V of this document discusses the information and data that support these proposed findings.

The FD&C Act, as amended by the Medical Device Amendments of 1976 (1976 Amendments) (Pub. L. 94-295), establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act establishes three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness: class I (general controls), class II (special controls), and class III (premarket approval) (see 21 U.S.C. 360c).

In 1979, FDA classified aversive conditioning devices as class II (see § 882.5235 (21 CFR 882.5235)), which was consistent with the recommendation of the Neurological Device Classification Panel in 1978. Class II devices are those devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions the Agency deems necessary to provide such assurance (section 513(a)(1)(B) of the FD&C Act).

Aversive conditioning devices, as a device type, administer an electric shock or another noxious stimulus to a patient to modify undesirable behavioral characteristics (see § 882.5235). Thus, ESDs intended for SIB and AB, which administer shocks to modify target behaviors, are within the aversive conditioning device classification regulation. As discussed in more detail in section I.D. of the previous proposed rule (81 FR 24386 at 24391), in the late 1970s, FDA and the panelists of the Neurological Device Classification Panel believed that performance standards could adequately assure the safety and effectiveness of aversives and proposed a classification accordingly. We received no comments from the public on the proposed rule, and we issued the final rule classifying aversives as proposed at § 882.5235 (44 FR 51726 at 51765, September 4, 1979).

As we explained during the previous rulemaking to ban ESDs for SIB and AB, and as remains true, FDA now has a better understanding of the risks and benefits presented by these devices than we did 44 years ago when these devices were classified. As summarized in section III.B and explained more fully in section V.E. of the 2020 Final Rule, the state of the art for the treatment of SIB and AB has progressed significantly over that time period (85 FR 13312 at 13337 through 13344). The development of the scientific literature and treatments for these conditions only underscores that the risk of illness or injury from the use of ESDs for SIB and AB is unreasonable and substantial.

FDA previously banned ESDs for SIB and AB in a final rule issued on March 6, 2020, pursuant to the Agency's authority under section 516 of the FD&C Act (85 FR 13312 at 13354). Specifically, section 516 of the FD&C Act provides that FDA may ban a device intended for human use if the Agency determines that the device presents substantial deception or an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling or change in labeling. Leading up to the final ban, FDA held a public meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee on April 24, 2014 (see 79 FR 17155, March 27, 2014) (Ref. 1), issued a proposed ban in the Federal Register of April 25, 2016, and considered comments on the proposal from interested stakeholders (81 FR 24386). These activities garnered significant interest, and FDA received and reviewed voluminous information to develop the final rule banning ESDs for SIB and AB.

FDA issued the 2020 ban because we determined, based on all available information and data at that time, that ESDs for SIB or AB present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling or a change in labeling. FDA found the weight of the evidence indicates that ESDs for SIB or AB present a number of psychological and physical risks. We determined the evidence does not establish that ESDs improve the underlying causative disorder or effectively condition individuals to achieve durable reduction of SIB or AB for a clinically meaningful period of time. FDA also found the weight of the evidence indicates that the state-of-the-art treatment for individuals with SIB or AB relies on multielement positive interventions, for example, paradigms such as positive behavior support (PBS) or dialectical behavioral therapy (DBT), sometimes in conjunction with pharmacological treatments (85 FR 13312 at 13315 and 13337). Even in cases in which behavioral modification plans include punishment techniques, the techniques are significantly less intrusive than ESDs and do not inflict pain; for example, they include timeouts.

Following the publication of the 2020 ban, the sole manufacturer and only facility to use ESDs for SIB and AB, The Judge Rotenberg Educational Center, Inc. (JRC), challenged in court FDA's authority to issue the 2020 ban. On July 6, 2021, the D.C. Circuit vacated the 2020 ban. See Judge Rotenberg Educational Center, Inc. v. FDA, 3 F.4th 390 (D.C. Cir. 2021). The court interpreted section 516 of the FD&C Act, as it existed at the time, and section 1006 of the FD&C Act, as not permitting FDA to ban devices for specific intended uses, in that instance ESDs for SIB or AB, without banning the device for all intended uses.

Following the court's decision, Congress enacted the Food and Drug Omnibus Reform Act of 2022 (FDORA) (Pub. L. 117-328). FDORA amended section 516(a) of the FD&C Act to expressly state that FDA's authority to ban a device intended for human use includes the authority to ban a device for one or more intended uses, and that a device banned for one or more intended uses is not a legally marketed device under section 1006 of the FD&C Act. As amended, the statute is clear that FDA may issue a ban such as the previous ban on ESDs for SIB or AB, which applies to one or more specific intended uses. After reviewing publications and other information that have become known to the Agency in the brief interim between the issuance of the previous ban in 2020 and now, and determining that it does not change our conclusion that ESDs for SIB or AB present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling or a change in labeling, FDA is proposing to ban ESDs intended for SIB or AB under section 516 of the FD&C Act, as amended.

Under section 516 of the FD&C Act, FDA may ban a device by regulation if we find, on the basis of all available data and information, that such a device with the relevant intended use(s) presents substantial deception or an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling or change in labeling (see 21 U.S.C. 360f(a)(1) and (2), as amended by section 3306 of FDORA).

Section 3306 of FDORA expressly provides that FDA has the authority to ban a device for one or more intended uses and that FDA's authority under section 516 of the FD&C Act is not limited only to bans of a device for all of its intended uses. The legislative history reinforces that section 516 of the FD&C Act, as amended, authorizes FDA to ban a device regardless of whether or not the ban includes other devices that are technologically similar but have different intended uses (see H. Rept. 117-348 at 65). The regulatory status of a device has long depended on its intended use(s), even before the enactment of the 1976 Amendments (see id.). A product's status as a device regulated by FDA, along with its classification, premarket pathway, labeling, and other requirements all “very much depend on its intended use” (id. at 65-66). The amendment to section 516 of the FD&C Act makes clear that the same principle applies to FDA's banning authority, permitting FDA to ban certain intended use(s) of a type of technology that meet the standard to ban devices, while not banning others that do not (see id. at 66).

A banned device, as defined in part by its intended use(s), is adulterated under section 501(g) of the FD&C Act (21 U.S.C. 351(g)), except to the extent it is being studied pursuant to an investigational device exemption under section 520(g) of the FD&C Act (21 U.S.C. 360j(g)). The FD&C Act defines various prohibited acts respecting adulterated devices (see 21 U.S.C. 331).

This proposed rule is also issued under section 701(a) of the FD&C Act, which provides FDA authority to issue regulations for the efficient enforcement of the FD&C Act (see 21 U.S.C. 371(a)). This rule, if finalized, would enable FDA to efficiently enforce the FD&C Act.

Part 895 sets forth the regulations that apply to banning devices under section 516 of the FD&C Act. Consistent with those regulations (and other applicable legal provisions), we are proposing findings, based on all available information and data, that ESDs for SIB or AB present a substantial and unreasonable risk of illness or injury.

In determining whether a risk of illness or injury is “substantial,” FDA considers whether the risk posed by the continued marketing of the device, or continued marketing of the device as presently labeled, is important, material, or significant in relation to the benefit to the public health from its continued marketing (see § 895.21(a)(1) (21 CFR 895.21(a)(1))).

Although FDA's device banning regulations do not define “unreasonable risk,” we explained in the preamble to the final rule establishing part 895 that, with respect to “unreasonable risk,” we will conduct a careful analysis of risks associated with the use of the device relative to the state of the art and the potential hazard to patients and users (44 FR 29214 at 29215, May 18, 1979). The state of the art with respect to this rule is the state of current technical and scientific knowledge and medical practice with regard to the treatment of patients exhibiting self-injurious and aggressive behavior.

Thus, in determining whether a device presents an “unreasonable and substantial risk of illness or injury” for one or more intended uses, FDA analyzes the risks and the benefits the device poses to individuals when used for such intended use or uses, comparing those risks and benefits to the risks and benefits posed by alternative treatments being used in current medical practice. Actual proof of illness or injury is not required; FDA need only find that a device presents the requisite degree of risk on the basis of all available data and information (H. Rept. 94-853 at 19; 44 FR 29214 at 29215).

If FDA determines that the risk can be corrected through labeling, FDA will notify the responsible person of the required labeling or change in labeling necessary to eliminate or correct such risk (see 21 CFR 895.25). Because FDA is proposing to determine that the risk associated with using ESDs for SIB or AB cannot be corrected or eliminated by labeling, we are not at this time notifying responsible persons regarding labeling. If FDA finalizes this ban as proposed, ESDs intended for SIB or AB will be adulterated and not legally marketed within the meaning of section 1006 of the FD&C Act when intended for SIB or AB.

To ban a device intended for human use, § 895.21(d) requires that a proposed ban briefly summarize:

• the Agency's findings regarding substantial deception or an unreasonable and substantial risk of illness or injury;

• the reasons why FDA initiated the proceeding;

• the evaluation of the data and information FDA obtained under provisions (other than section 516) of the FD&C Act, as well as information submitted by the device manufacturer, distributer, or importer, or any other interested party;

• the consultation with the classification panel;

• the determination that labeling, or a change in labeling, cannot correct or eliminate the deception or risk;

• the determination of whether, and the reasons why, the ban should apply to devices already in commercial distribution, sold to ultimate users, or both; and

• any other data and information that FDA believes are pertinent to the proceeding.

The previous proposed and final ban on ESDs for SIB or AB describe this information extensively, and we do not repeat that information in full here. Instead, because the primary change in circumstances leading to this rulemaking is of a legal (not scientific) nature, this proposed rule references the information and findings from the previous rulemaking and briefly summarizes that information with reference to the previous proposed rule, final rule, or both, as applicable. In addition, this proposed rule discusses the new data and information that FDA has become aware of since the 2020 Final Rule.

FDA notes that, although a banned device or banned intended use of a device is not barred from clinical study under an investigational device exemption pursuant to section 520(g) of the FD&C Act, any such study must meet all applicable requirements. These include, but are not limited to, requirements for: protection of human subjects (21 CFR part 50), financial disclosure by clinical investigators (21 CFR part 54), approval by institutional review boards (21 CFR part 56), and investigational device exemptions (21 CFR part 812).

FDA has determined, on the basis of all available data and information, that ESDs for SIB or AB present a substantial and unreasonable risk of illness or injury. Given the relatively short amount of time since the previous ban that we finalized in 2020, there is very little relevant data or information that we have not already considered and discussed in the previous rulemaking. The few publications and other information that have become known to the Agency in the brief interim between the issuance of the previous ban in 2020 and now do not change our conclusions regarding the risks or effects of ESDs for SIB or AB or the state of the art of treatment for this patient population. We are therefore referencing our previous discussion and findings (81 FR 24386 at 24386 through 24412 and 85 FR 13312 at 13312 through 13349) in this rulemaking and supplementing them with an explanation of how since-developed data and information have added to our understanding of the relevant issues. We also are associating with this rulemaking the public dockets created for the previous rulemaking (Docket No. FDA-2016-N-1111) and the Neurological Devices Panel of the Medical Devices Advisory Committee on April 24, 2014 (Docket No. FDA-2014-N-0238) and consider them part of this proposed rule. All of the documents associated with Docket No. FDA-2016-N-1111 and Docket No. FDA-2014-N-0238 are contained in the docket for this proposed rule as well. With regard to the available data and information, this proposed rule therefore focuses on new information and data that we have become aware of since we issued the previous ban.

To identify and assess information that we had not previously considered, we conducted a search for literature on the risks and effects of ESDs for SIB or AB published since our systematic literature review for the 2016 Proposed Rule and again assessed the state of the art for treating SIB or AB.

Our search returned the following new sources: (1) 5 research studies (3 case reports, an open label add-on study, and a retrospective chart review); (2) 4 policy or consensus statements; a task force report; (3) 11 commentaries by researchers, academics, or practitioners; (4) a set of practice guidelines; (5) a followup survey of 88 former patients of JRC that did and did not have ESDs as part of their treatment plans; (6) and a meta-analysis. FDA weighed the new information according to the same factors that we explained in the 2016 Proposed Rule and 2020 Final Rule.

During the development of the 2020 Final Rule, in the form of comments to the docket, JRC provided the Agency with several JRC studies, information, and numerous records of patients with SIB or AB whose treatment plans include ESD use. Of the five new research studies, four are authored or coauthored by JRC staff. The four JRC research studies appear to be based largely on this same information and patient data and, as discussed in sections V.A and B, have many of the same significant limitations identified by FDA as the previously submitted studies, meaning the studies are less likely to support confidence in generalizable results than studies with more scientifically sound designs and methodologies. As a result, while the publication process adds some reassurances to the credibility of the information and data, presenting previously submitted data in a different form does little to add to overall knowledge about the risks and effects of ESDs for SIB or AB.

Generally speaking, little new information or data have developed since our previous consideration of banning ESDs for SIB or AB. Nonetheless, the new material is consistent with the evidence FDA previously considered regarding the risks presented by this device, the lack of evidence of its effectiveness for the treatment of SIB or AB, and the state of the art for treating SIB or AB, which includes successful interventions that are less restrictive and lower risk, as has been the case for decades (85 FR 13312 at 13341). Accordingly, we have again found that the devices present a substantial and unreasonable risk of illness or injury that cannot be corrected or eliminated by labeling or change in labeling.

The new studies and other materials that FDA reviewed are consistent with our previous findings regarding the risks of ESDs for SIB or AB, including likely underreporting of adverse events (AEs). As explained in the 2016 Proposed Rule and 2020 Final Rule, the risks presented by ESDs are both psychological (including suffering) and physical (including pain), each having a complex relationship with the electrical parameters of the shock. The subjective experience of the person receiving the shock can therefore be difficult to predict. Physical reactions roughly correlate with the peak current of the shock delivered by the ESD. However, various other factors such as sweat, electrode placement, recent history of shocks, and body chemistry can physically affect the sensation. As a result, the intensity or pain experienced by an individual from a particular set of shock parameters can vary greatly from patient to patient and from shock to shock. More information about the relationship between the electrical parameters of the shock and conditions that may affect patient perception can be found in section I.C. of the 2016 Proposed Rule (81 FR 24386 at 24390 through 24391) and Response 14 of the 2020 Final Rule (85 FR 13312 at 13322).

Possible adverse psychological reactions are even more loosely correlated with shock strength or intensity (85 FR 13312 at 13322). To cause such adverse reactions, the shock needs to be subjectively stressful enough to cause trauma or suffering, which does not necessarily require a strong shock. Trauma becomes more likely, for example, when the recipient does not have control over the shock or has developed a fear of future shocks, neither of which is an electrical parameter of the shock. A more detailed explanation of these phenomena can be found in the 2016 Proposed Rule (81 FR 24386 at 24387) and the 2020 Final Rule (85 FR 13312 at 13324 through 13325).

To summarize, FDA found that the medical literature shows ESDs present a number of psychological harms including depression, PTSD, anxiety, fear, panic, substitution of other negative behaviors, worsening of underlying symptoms, and learned helplessness (becoming unable or unwilling to respond in any way to the ESD); and the devices present the physical risks of pain, skin burns, and tissue damage.

FDA also considered risks identified through other sources, such as experts in the field, State agencies that regulate ESD use, and records from the only facility that has recently manufactured and is currently using ESDs for SIB or AB. These sources further support the reports of risks in the literature and indicate that ESDs pose additional risks such as suicidality, chronic stress, acute stress disorder, neuropathy, withdrawal, nightmares, flashbacks of panic and rage, hypervigilance, insensitivity to fatigue or pain, changes in sleep patterns, loss of interest, difficulty concentrating, and injuries from falling (85 FR 13312 at 13315). For more information about FDA's analysis regarding the risks of ESDs for SIB and AB, see section V.C. of the 2020 Final Rule (85 FR 13312 at 13321 through 13332).

We also concluded that the medical literature likely underreports AEs. This is attributable to several factors including the small number of subjects in the studies, many of whom have impaired ability to demonstrate and communicate AEs; potential attribution by clinicians of adverse effects to the patients' cognitive, intellectual, or psychiatric conditions rather than to the device; methodological limitations such as study design and the lack of a prespecified systematic plan for monitoring AEs; and researcher bias (81 FR 24386 at 24395 through 24396; 85 FR 13312 at 13329 and 13331).

The new sources that are based largely on data and information that FDA previously reviewed when developing the 2020 Final Rule support our previous determinations for the 2020 Final Rule about the types of risks posed by ESDs for SIB or AB. As a result, these new sources do not significantly affect our previous assessment of risks. Specifically, one meta-analysis of 150 reports and studies (Ref. 2) and four commentaries (Refs. 3 to 6), including one by a JRC staff member, report AEs associated with ESDs for SIB or AB. These sources identify the following physical and psychological risks:

• pain (Refs. 2, 3, 5);

• escape or avoidance responses (Refs. 3 and 5);

• extreme anxiety manifesting as screaming, crying, negative vocalizations when ESD was implemented, and attack (Refs. 3 and 5);

• tensing of the body (Ref. 3);

• emotional behavior (Ref. 3);

• fear (Refs. 4 to 6);

• feeling terrorized (Ref. 6);

• panic (Ref. 5);

• “freezing” (Ref. 5);

• attempts to remove the device (Ref. 5);

• distress (Refs. 2 and 4);

• burns (Refs. 3 and 6);

• tremor in the thigh during activation (Ref. 3); and

• temporary skin discoloration (Ref. 3).

In addition, the new sources based primarily on data and information that FDA had not previously reviewed for the 2020 Final Rule generally support these risks. A task force of the Association for Behavior Analysis International (ABAI) reports pain and attempts to remove the device (Ref. 7) and two of the studies (Refs. 8 and 9) report pain, escape/avoidance, and/or temporary anxiety, as noted below. While some of these new sources suggest that there is no strong evidence of negative “side effects” of ESDs based on research to date (Ref. 7) or no occurrence of AEs (Ref. 8), these conclusions are based on studies that have significant limitations, as discussed below and in the previous rulemaking (81 FR 24386 at 24400 through 24401). During the previous rulemaking, some experts expressed concern about a heightened risk of AEs “from exposing a member of a vulnerable patient population to continual, painful shocks over a period of years, in many cases several years” (85 FR 13312 at 13327).

As discussed in section V.B., the new studies continue to demonstrate use of ESDs for lengthy, indefinite periods of time and adaptation of some patients to the shocks (they no longer respond to shocks), even at the strongest level. The use of ESDs for long periods and on patients who have adapted to shocks would provide greater opportunity for AEs to occur, or for existing AEs to get worse due to cumulative effects, in a population largely consisting of vulnerable individuals. A treatment plan that includes use of ESDs for individuals with SIB or AB indefinitely (Ref. 10) would further heighten the concern about the risks of AEs. As explained further in section V.B., a 173-patient retrospective chart review study suggests that JRC attempts “planned fading” of ESD use, defined in that study as the removal of all ESD devices for any period, for only a relatively few number of individuals the attending clinician believes are likely to succeed (Ref. 9). 2 Thus, most of the individuals would continue to accumulate exposure to the risks of ESDs for SIB or AB. Further, a decision to use ESDs for “long-term management” of SIB or AB (Ref. 10) could suppress behavior in a manner that masks an underlying medical condition (Ref. 7). This in turn can affect access to (or the desire to access) effective treatments, which itself represents a risk to health.

The new sources also add evidence for the likelihood of underreporting of AEs for the same reasons we previously found for the medical literature reviewed for the 2020 ban: the impaired ability of many subjects to demonstrate and communicate AEs, which also increases the risk of harm to these individuals; difficulty of practitioners to recognize feedback from patients indicating that an AE occurred; methodological limitations in the studies; and researcher bias. Thus, while some new sources indicate that research “does not provide strong evidence that [ESDs are] associated with negative side effects” and that the “few studies presenting data on the side effects of [ESDs] have reported only positive collateral changes in responding,” (Ref. 7), these conclusions need to be viewed with these limitations in mind.

Like the medical literature considered for the 2020 Final Rule, most of the new studies involve a small number of patients, some of whom likely would have difficulty communicating or otherwise demonstrating AEs, including injuries, due to cognitive, intellectual, or psychiatric conditions. As noted in the 2016 Proposed Rule (81 FR 24386 at 24395), this difficulty may prevent providers from recognizing feedback from patients indicating that an AE has occurred.

None of the new studies prospectively planned for the systematic observation and collection of data regarding AEs, and very few AEs are reported. Only one new study on the use of the GED, the only ESD still in use for SIB or AB, identified any AEs (Ref. 9). That study, a retrospective chart review of 173 patients authored by JRC staff, reports only what the authors “anecdotally” found were “the most common side effects”: escape/avoidance responses and temporary anxiety during the period between occurrence of the behavior and the “programmed consequence,” i.e., shock (Ref. 9). The study reports that staff members who administered shocks were “prompted to report any adverse conditions,” and acknowledges that “a standardized a priori system was not employed” for monitoring AEs (Ref. 9). Thus, the study does not report systematic, recorded counts of adverse events based on specific identification or followup protocols. Rather, it reports the authors' subjective opinion in hindsight. Three of the other new studies, two of which were authored or coauthored by JRC staff, include no assessment of AEs (Refs. 10 to 12).

The remaining new study, a case report coauthored by JRC staff, reports “no evidence of physical or psychological adverse effects when GED is administered per protocol” (Ref. 8). Despite that statement, the study lists temporary pain as a “con” of GED use. Further, the JRC coauthor of the study, who is also coauthor of three of the other new studies, continues to acknowledge that “[t]he obvious effect of [the ESD] is pain caused when electrical current stimulates nociceptors and sensory receptors” (Ref. 3). As explained in the 2016 Proposed Rule and 2020 Final Rule, FDA considers pain to be an AE. Such biases against recognizing and/or recording certain harms as AEs creates doubt that the studies adequately considered AEs and, therefore, the risks of the device. Such biases also would impair an accurate benefit-risk assessment; undesirable effects should not be presumed unavoidable, much less go unaccounted for, even if they ultimately prove to be reasonable. The pain ESDs cause is relevant because, although ESDs are intended to apply an aversive stimulus, the pain they cause to attempt to develop the aversion is nevertheless harmful.

All of the new studies are retrospective reviews of clinical experience, not prospective studies. While retrospective reviews can be informative, creating a plan to identify AEs in a standardized, forward-looking way and ensure a comprehensive record from the outset will generally provide much stronger support for a conclusion that a lack of reported AEs means a lack of AEs to report.

As with the earlier studies, researcher bias and author conflicts of interest also may have contributed to underreporting of AEs. As indicated in section III.D., JRC is the sole manufacturer and only facility to use ESDs for SIB or AB. Four of the five new studies that looked at ESDs for SIB or AB were authored or coauthored by current JRC staff and may have minimized AEs. As noted earlier, only one study reports any AEs experienced by patients and limits reporting only to the “most common side effects,” of which pain was not included (Ref. 9).

The other new sources that FDA reviewed also suggest a lack of attention to the careful and systematic assessment of AEs in research involving ESDs, and more generally, in research involving intellectually and developmentally disabled individuals (Refs. 2, 4 to 6, 8, and 13 to 17). For instance, one meta-analysis looking at reporting of AEs in research involving young autistic children notes that “[s]tudies of effectiveness did not systematically define, monitor, or measure adverse events; instead they were reported in an ad hoc fashion and considered tangential to the studies” (Ref. 2). Another author discussing research involving autistic individuals opines that the inadequate attention to and examination of harms amounts to “negligent reporting” (Ref. 13). While not all individuals with SIB or AB are autistic, this information informs our general understanding of the limitations in research involving individuals with intellectual and developmental disabilities. This information tends to show that research that, in general, involves people who have difficulties communicating and, more specifically, involves the use of ESDs for SIB or AB, often does not provide a complete picture of AEs.

Given the foregoing, FDA has not changed its determination that AEs very likely have been underreported in the literature. More information about FDA's prior conclusion that AEs likely are underreported in the literature can be found in the 2020 Final Rule at Responses to Comments 26-29 of (85 FR 13312 at 13329 through 13332).

Thus, based on the totality of the information available to FDA, our determination regarding the risks posed by ESDs for SIB or AB identified in the 2020 Final Rule has not changed.

The new information that FDA reviewed does not change our previous determinations regarding effectiveness of ESDs for SIB or AB. For the 2020 Final Rule, FDA determined that some individuals subject to ESDs may exhibit an immediate interruption of the targeted behavior if the shock is applied while the behavior is occurring, assuming the individual has not adapted to the shocks (85 FR 13312 at 13333). However, we also determined that the available evidence does not establish that ESDs improve the underlying causative disorder or condition an individual to achieve a durable reduction of SIB or AB for a clinically meaningful period of time (85 FR 13312 at 13333). A durable effect is one where an individual develops a conditioned response, so the target behavior, along with the frequency of shocks, is significantly reduced over a clinically meaningful period of time, either while the individual continues to wear the ESD or after the ESD is removed.

As we discussed in the 2020 Final Rule (see 85 FR 13312 at 13332), FDA found some information in the scientific literature to suggest ESDs may reduce SIB and AB in some individuals. However, as we explained, the evidence cannot be generalized and is insufficient to demonstrate effectiveness because the studies suffer from serious limitations that limit confidence in the results, including weak design, small size, confounding factors, outdated standards for conduct, and study-specific methodological limitations. As discussed in the 2016 Proposed Rule, generally a study's strength or weakness is related to design in a number of ways, particularly through randomization, control, and the number of study subjects. There have been no large, randomized, and controlled trials, or even any large or randomized trials, of ESDs for SIB or AB. 3 Although there have been some studies with some level of controls, the controls have been inadequate for effectiveness to be demonstrated and they suffer from other significant limitations. For further discussion about the strengths and weaknesses of study designs and the limitations in the literature previously reviewed by FDA, see section II.B.2 of the 2016 Proposed Rule (81 FR 24386 at 24400 through 24401) and responses to Comment 33 of the 2020 Final Rule (85 FR 13312 at 13332 through 13333).

For instance, as discussed in the previous rulemaking, one study used a prospective case-control design. In addition to not being randomized, the study also suffers from significant methodological limitations. The study was not blinded, the sample size was extremely small, and an unvalidated surrogate endpoint (decrease in mechanical restraint rather than a direct measure of SIB) was used as the primary outcome measure (81 FR 24386 at 24400; 85 FR 13312 at 13333). The study also did not systematically assess AEs (85 FR 13312 at 13329).

FDA also reviewed a retrospective chart review during the previous rulemaking. Retrospective reviews are often considered a relatively weaker design because they do not include a control group. The study also suffers from various methodological limitations that affected the weight of the evidence (see 81 FR 24386 at 24401). The bulk of the scientific articles reviewed during the prior rulemaking suggesting effectiveness of ESDs for SIB and AB were case reports or series. Case reports or series are even weaker than retrospective chart reviews because they report on, and attempt to explain, the experiences of very few, or even single, individuals (81 FR 24386 at 24400). Further, designs that take an outcome as given and then work backwards in an attempt to explain it are more vulnerable to bias than prospective designs.

As explained in the 2016 Proposed Rule, conclusions drawn from study designs that are not randomized or controlled are generally considered weaker because they do not rule out other causes for any differences in results, including selection bias, as effectively as other study designs. Many factors contribute to the manifestation or reduction of target behaviors and therefore can be significantly confounding (81 FR 24386 at 24400). It is difficult to draw conclusions regarding the effectiveness of ESDs from a study that does not control for such confounding factors. Studies that do not plan for the systematic observation and collection of data about AEs also may overemphasize benefits, unduly implying greater safety and reasonableness of the risks because such a study would not fully account for the risks. Such studies will yield weaker conclusions with respect to the benefit-risk profile. As noted in the 2016 Proposed Rule, in the case of ESDs used for SIB or AB, randomization, control, large numbers of subjects, and AE reporting are critical to understanding the benefit-risk profile (81 FR 24386 at 24400).

The Agency also has had concerns regarding the fact that some of the authors of such studies and a member of one publication's editorial board were affiliated with JRC, which suggests potential researcher bias and conflicts of interest (81 FR 24386 at 24401). For more information on the limitations identified by FDA in the medical literature FDA considered for the 2020 Final Rule, see the 2016 Proposed Rule (81 FR 24386 at 24400 and 24401) and Responses 31 and 33 in the 2020 Final Rule (85 FR 13312 at 13332 and 13333).

As explained in the 2020 Final Rule, the ability to achieve durable effects by aversively conditioning behavior is critical to the evaluation of the effectiveness of ESDs for SIB or AB (see 85 FR 13312 at 13333). In its comments in the previous rulemaking, JRC relied on its fading of some individuals off ESDs to support its arguments regarding the device's ability to condition an individual to achieve a durable reduction in SIB and AB. The gradual reduction in the use of the device is part of “fading,” which would presumably be implemented once the individual has associated the target behaviors with the noxious stimulus. However, both the previously reviewed and new evidence indicate that only a small percentage of individuals at JRC (the only facility that applies the devices for SIB or AB) have been completely faded off the ESD—and that the device has been used on some individuals for years and even decades (see 85 FR 13312 at 13335 and 13336; Refs. 7 to 9). While one study suggests that there also are a number of patients who have tolerated some degree of fading with continued availability of the ESD (estimated at 20 percent ranging from hours to months) (Ref. 8), the study acknowledges that the percentage is only an estimate and suffers from a number of the limitations discussed above.

Among the new studies, the 173-patient retrospective review indicates that JRC views fading, defined in that study as the removal of all ESD devices for any period, as likely to succeed in only a small number of individuals. JRC selects for “planned fading” only a small percentage of individuals whom JRC assesses to have likely demonstrated low rates of problem behaviors over extended periods of time, higher rates of alternative behaviors, and the acquisition of new skills (23 of 173 patients in the study) (Ref. 9). Also, as has been observed in the literature, once the ESD is removed, SIB and AB can exceed pre-baseline levels (85 FR 13312 at 13335). This evidence undermines the claim that ESDs are effective for durable behavior conditioning for SIB or AB. Further, JRC provided no information regarding clinical protocols, treatment plans, or behavior frequencies for individuals after they stopped use and left JRC. As explained in the 2020 Final Rule, such data are important in order to understand, for example, whether behaviors worsened or improved after discontinuation of ESD use and whether ESDs or other, non-aversive, treatments are responsible for any successes (85 FR 13312 at 13336).

In the previous rulemaking, FDA also discussed evidence indicating that some individuals can experience adaptation to ESD shocks after being shocked for some period of time. This means that, to the extent a patient may have been responding to ESD shocks, the patient no longer responds, at least at the level of shock strength that has been used on them. For these individuals, even immediate interruption of behavior may not result from use of shocks. Experts in the field consider adaptation to be evidence of ineffectiveness (see 85 FR 13312 at 13336 and 81 FR 24386 at 24399). JRC has acknowledged that adaptation may necessitate an alternative method to modify behaviors instead of an ESD (see 85 FR 13312 at 13336). As we stated in the 2020 Final Rule, JRC's Director of Research at the time said JRC had “a very comprehensive alternative behavior program” that was “very effective” after adaptation to the stronger version of JRC's ESD, even for patients engaging in SIB that could result in serious injury to themselves (85 FR 13312 at 13336). That JRC's own providers ultimately turn to alternative behavioral programs, even for severe behaviors, speaks both to the effectiveness of state-of-the-art approaches and the ineffectiveness of applying electrical shocks for SIB or AB.

Considering such evidence in the previous rulemaking, FDA concluded that the limited data regarding the effects of ESDs for SIB or AB are inadequate to demonstrate that ESDs are effective for durable behavior conditioning. For more information about FDA's previous determination regarding the effects of ESDs on SIB and AB, see section V.D. of the 2020 Final Rule (85 FR 13312 at 13332 through 13337).

The information in the new sources does not change the Agency's prior determinations about the short- and long-term effects of ESDs on SIB or AB. Most of the new studies are authored or coauthored by JRC staff and appear to be based on much of the same or similar data JRC previously submitted, with similar limitations, albeit presented in a different format. As with the studies FDA reviewed for the 2020 Final Rule, the new studies similarly suggest some immediate effects of ESDs for SIB or AB for some individuals, in particular that the ESDs interrupted the target behavior (Refs. 8 to 12). Some commentaries, consensus statements, the ABAI task force report, and the 88-patient survey also offer some support for the immediate effect of ESDs on targeted behavior (although some individuals may not respond and/or may adapt to the shock intensity and alternative approaches are used) (Refs. 3, 5, 7, 14, 18, and 19). The new studies also conclude that ESDs have some level of durable effectiveness for some individuals with SIB and AB. Relying on information that FDA previously reviewed and some of the new studies discussed in this proposed rule, the ABAI task force similarly states that ESDs “can be effective in suppressing problem behavior for up to 5 years” and that “responding typically remains suppressed under [ESDs] over the long run” (Ref. 7). However, due to the various limitations of these studies as well as the evidence indicating adaptation to the device and potentially unending ESD use for some individuals, FDA has determined that the evidence still does not demonstrate that the devices are effective for durable behavior conditioning for SIB or AB for a clinically meaningful period of time, much less that they present a favorable benefit-risk profile.

The new studies suffer from many of the same limitations as those studies FDA considered and discussed in the 2016 Proposed Rule and 2020 Final Rule. The three case report studies (Refs. 8, 11, and 12) and one open label add-on trial (Ref. 10) involve a very small number of patients (one to four), which makes generalization of any results difficult. Four of the five new studies were authored or coauthored by JRC staff, which may introduce researcher bias. All of the studies lack robust experimental controls and, as explained above, likely underreport AEs.

The new studies also include significant confounding factors, such as the presence of concurrent treatments or changes in other treatments over a period of time. The JRC 173-patient retrospective chart review acknowledges that, “[d]uring treatment, a given participant may have received additional treatments including psychotherapy, psychopharmacology, and/or various behavioral interventions.” The ABAI task force report describes one example of an additional treatment, a “holster program,” used by JRC in some cases where a patient adapts or does not respond to the GED-4 to decrease problem behavior (see also Ref. 8). Individuals in the program receive continuous access to a positive reward (preferred videos, music, etc.) for keeping their hands in a holster for increasing amounts of time. If they remove their hands, the reward will stop, and a shock will be administered. Once the individuals can keep their hands in the holsters for 10 minutes, they continue to receive regular “practice sessions” to “maintain the effectiveness of holster-wearing to decrease problem behavior throughout the remainder of the day.” While wearing the holster during the day, if a target behavior occurs, the individual receives a shock and a 10-minute holster session (Ref. 7). The description of the holster program, while unclear in some particulars, suggests that increasing opportunities for positive reinforcement supports any reduction of target behaviors. The use of this positive reinforcement method introduces a confounding factor in the determination of the effectiveness of ESDs; the reward system, rather than the ESD, may have induced or helped induce any desirable effects on behavior. Alternatively, or perhaps as a complement to the reward system, use of the holster may have controlled or helped control the behavior. Other concurrent treatments or changes to treatments may have similar confounding effects.

Another limitation of some of the new studies stems from the fact that the behaviors targeted for ESD use are not consistent across the studies, and they were not limited to SIB or AB. Target behaviors spanned a wide range, such as “members of a chain of behaviors ( e.g., posturing and threats) that consistently led to the ultimate behavior, attempts to engage in the behavior, and vestigial versions of the behavior” (Ref. 9). Thus, vaguely described improvements that may, for example, include reductions in “vestigial versions of the behavior” are not obviously evidence of effectiveness for treating SIB or AB. Such claims also speak to a vulnerable population being subject to invasive behavioral control techniques; that is, such claims may also speak to an increased risk of AEs from an overly broad set of targeted behaviors. The sources also indicate that ESDs may be used for other categories of behavior such as noncompliant, destructive, and major disruptive behaviors as well as attempts to remove the device (Refs. 7, 9, and 11). Delivering an electric shock, for instance, for disruptive behavior is not clearly addressing self-injury or aggression. In the same vein, use of the device in an attempt to prevent its removal is not only difficult to rely on as evidence of effectiveness for SIB or AB, but such use also underscores that vulnerable patients are unable to avoid the risks presented by the device, such as pain. This in turn can increase other risks, such as the risk of learned helplessness (Ref. 20). Such broad target behaviors also suggest that a population broader than individuals exhibiting SIB and AB may be subject to the invasive behavioral control of ESDs and the risks they present.

Some studies acknowledge these methodological limitations. The JRC 173-patient retrospective chart review (Ref. 9) explains that “a wide range of behavior topographies [were] targeted” because they “were associated with aggression and self-injury,” and the “participants lacked homogeneity outside of the uniting factor of behavior problem severity and refractory nature.” In other words, the study included participants with widely differing behavioral characteristics, although their severity was considered similar. The study also recognizes, “[t]he participants carried a variety of diagnoses and may have responded differently because of their diagnostic classification” and “[v]arious pathophysiological and environmental determinants may lead to such behaviors.” This study also noted, “the frequency data lacks interobserver reliability,” meaning it did not account for or address variability between different observers' subjective judgments. The open label add-on trial (Ref. 10) identifies some of the same limitations that make it difficult to conclude that any observed reductions in target behavior are evidence of effectiveness of ESDs for SIB or AB.

New evidence regarding the lengthy, often indefinite, time periods that ESDs have been used on individuals and the adaptation of some individuals to the shocks further supports our determination that ESDs have not been demonstrated to be effective. For example, a four-patient case report study suggests that, for some patients, ESDs would be indicated indefinitely, similar to insulin for diabetes or antiarrhythmic and antihypertensive drugs for cardiovascular disease (Ref. 8). The ABAI task force reports that JRC's approach is that “most clients will need to receive treatment [with ESDs] for lengthy periods of time (5 to 20 years)” and that “this does not appear to be a treatment that can be effectively faded or discontinued quickly” (Ref. 7). This suggests that the device is not effective for durable behavior conditioning for SIB or AB, and is, therefore, not effective for its intended use.

The new sources also support FDA's previous finding that ESDs may even lose any immediate effect for some individuals exhibiting SIB or AB. The 173-patient retrospective chart review from JRC reports that for some participants the “GED lost efficacy or was only partially effective and was substituted for [sic] a more intense stimulus (GED-4)” (Ref. 9). The authors note that adaptation was consistent with earlier studies that identified habituation to shock intensity by some patients and the need for more-intense shocks to eliminate targeted behavior. The JRC four patient case report study noted this effect in one patient (Ref. 8). The ABAI task force also reported adaptation to the ESD based on a visit by members spanning 2 full days in July 2022 to assess JRC's use of ESDs. The report states that “[i]n some cases, the intensity of the shock must be increased to improve and/or maintain its efficacy” and “a [JRC] client will be moved from the GED-3 to the GED-4 if the GED-3 does not reduce the behavior sufficiently or if the client's behavior begins to show habituation to the GED-3” (Ref. 7). According to the report, patients can even habituate, or may not respond to, shocks from the GED-4, which provides shocks that are significantly stronger than those provided by the GED-3 (41 milliampere (mA) vs. 15 mA).

As a result of such weaknesses and limitations, the available data, including the data and information in the new studies and other materials, are not sufficient to demonstrate that ESDs for SIB or AB are effective for durable behavior conditioning or that they have a favorable benefit-risk profile.

Based upon all available information and data, FDA continues to find that while ESDs may result in the interruption and immediate cessation of SIB and AB for some individuals if the individual has not adapted to the shocks, ESDs have not been demonstrated to be effective at improving the underlying condition or conditioning an individual to achieve a durable reduction of SIB or AB for a clinically meaningful period of time. The evidence does not establish a favorable benefit-risk profile, and the newer evidence suggesting indefinite use of the devices for ongoing management of symptoms may indicate a worse benefit-risk profile.

In determining whether a device presents an unreasonable and substantial risk of illness or injury, FDA analyzes the risks and benefits that the device poses to individuals relative to the state-of-the-art of treatment for the intended population—that is, the current state of technical and scientific knowledge and medical practice, and the potential hazard to patients and users. As explained in the 2020 Final Rule, FDA found that scientific and medical advances, concerns for ethical treatment, and a desire to create generalizable interventions that work in community settings led behavioral scientists to develop treatments for SIB and AB that are low risk and have generally been successful. The available information indicated that state-of-the-art treatments of SIB or AB are multielement positive interventions ( e.g., paradigms such as PBS or DBT), sometimes in conjunction with pharmacological treatments, as appropriate (85 FR 13312 at 13341; 81 FR 24386 at 24410). When restrictive elements or punishment techniques were used, they supplemented other behavioral intervention elements, were much less intrusive, and were not painful; they were considered both compatible with PBS and beneficial (see 85 FR 13312 at 13341).

As we said in the 2020 Final Rule, the use of ESDs does not teach a person new skills or replacement behaviors, does not mitigate the underlying cause of their SIB or AB, and has not been demonstrated to be effective for behavioral conditioning, which is especially difficult to achieve for those who have conditions that impair their ability to understand consequences and react by changing their behaviors. These are some of the reasons that the field of applied behavior analysis (ABA) as a whole moved away from highly intrusive physical aversive conditioning techniques such as ESDs decades ago (85 FR 13312 at 13340).

FDA determined that although positive behavioral interventions may not always be completely successful in all patients, positive-only approaches have low risk and are typically successful, on their own or in conjunction with pharmacotherapy, regardless of the severity of the behavior targeted or the setting, and can achieve durable long-term results while avoiding the risks posed by ESDs (85 FR 13312 at 13315). As noted above, when practitioners felt punishment techniques were helpful, such techniques were much less intrusive than the use of ESDs; for example, they included timeouts, holds, and facial screening (85 FR 13312 at 13341). For a detailed description of FDA's assessment of state-of-the-art treatments for SIB and AB for the 2020 Final Rule, see section V.E. of the 2020 Final Rule (85 FR 13312 at 13337 through 13344) and section II.C. of the 2016 Proposed Rule (81 FR 24386 at 24403 through 24410).

The evidence still indicates that positive-only approaches, such as approaches based on differential reinforcement and skill-based instruction, have been shown to be highly successful in treating many types of severe problem behaviors (Ref. 7). Even when ESDs are used for SIB or AB, they generally are supplemented by state-of-the-art and/or other less intrusive approaches even for severe cases (Ref. 9). An example of an alternative treatment that practitioners may turn to if an individual habituates to the strongest ESD available is the holster program, which is a less intrusive paradigm that increases the use of positive rewards. In short, to the extent new information and data bear on the state of the art, they underscore why the field as a whole has, for decades (81 FR 24386 at 24387), moved away from ESDs and turned toward less intrusive techniques to treat SIB or AB effectively (Ref. 21). Further, the newer information and data emphasize that ESDs are not in fact treatments of last resort, even at the facility that has previously made such claims. As discussed further in section V.C., the ABAI task force reports that JRC rarely conducts analogue functional analyses (FAs), despite the fact that experts consider FA the “gold standard” assessment strategy for problem behavior (Ref. 7). This practice suggests that individuals may not experience the “almost unlimited” range of alternative treatments available (Ref. 7) based on an up-to-date, location-specific, comprehensive FA prior to JRC incorporating ESDs into their treatment plan. This failure to systematically identify and exhaustively implement alternatives undercuts the certainty that JRC's patients would not respond to less intrusive treatment, are uniquely refractory, and that the devices are applied as a last resort, as is suggested by the device labeling. 4

Thus, FDA concludes that state-of-the-art treatment for SIB and AB involves positive behavioral techniques, with or without pharmacotherapy, and that positive-only approaches have low risk and are generally successful even for challenging SIB and AB, in both clinical and community settings. Moreover, when punishment techniques are used in state-of-the-art behavior modification plans, they are not painful and are much less intrusive.

After considering all available data and information for the 2020 Final Rule, FDA determined that labeling or a change in labeling cannot correct or eliminate the unreasonable and substantial risk of illness or injury of ESDs for SIB or AB (85 FR 13312 at 13344 and 13345). FDA further determined that labeling cannot limit the risks to only the most refractory patients. The only ESDs for SIB or AB that are currently in use, two models of GED manufactured and used by JRC, are labeled for use only in individuals refractory to other treatments. Such a subpopulation is difficult or impossible to define (85 FR 13312 at 13332). Further, FDA found the available evidence casts doubt on whether the devices are in fact applied as a last resort after attempting all other approaches as indicated in the labeling (and as claimed by one commenter on the previous proposed rule (JRC)) (Ref. 22). These determinations remain true after FDA's updated review of the available literature.

More importantly, no subpopulation has been identified in which ESDs are effective for SIB or AB or do not pose the risks identified in the previous rulemaking and discussed earlier in this document. There are also no data suggesting ESDs are more likely to be effective for SIB or AB or less likely to pose these risks in a subpopulation that is refractory to other treatments or in any other subpopulation. Regardless of how the device is labeled, the individual subject to it will receive shocks intended to be painful and thereby be subject to the physical and psychological risks described in section V.A above, without demonstrated effectiveness (see also 85 FR 13312 at 13344).

Further, individuals with intellectual or developmental disabilities may not communicate or be able to communicate information for the device user to change the manner in which the device is used to correct or eliminate the risks (81 FR 24386 at 24412; 85 FR 13312 at 13344). Impaired communication of the effects of the device further prevents labeling from reducing risks. Accordingly, we concluded that no manner of labeling will correct or eliminate the substantial and unreasonable risks of these devices (see 81 FR 24386 at 24411 and 24412; 85 FR 13312 at 13344).

No additional information has come to FDA's attention indicating that labeling or a change in labeling can correct or eliminate the substantial and unreasonable risks of these devices. As noted in section V.C., the new evidence indicates that JRC rarely conducts FAs of patients. This absence of FAs conducted by JRC suggests that the existing limiting language in the labeling has little effect on mitigating risks by focusing on refractory cases. Indeed, as discussed more in section V.B. above, refractory cases at JRC are ultimately treated with less invasive approaches suggesting that as used, ESDs are not a treatment of last resort. This reinforces our prior determinations that labeling specifying a refractory population would not correct or eliminate the substantial and unreasonable risk, and that there are no labeling changes that would mitigate the risks posed by these ESDs.

Finally, as explained above and in the 2020 Final Rule, no manner of labeling will correct or eliminate the risks for patients receiving shocks, many of whom may not communicate or be able to communicate information about AEs as a result of intellectual or developmental disabilities (85 FR 13312 at 13344). The device will continue to present the same unreasonable and substantial risk of illness or injury for these individuals regardless of the labeling. Based on this information and data, FDA concludes that labeling, or a change in labeling, cannot correct or eliminate the unreasonable and substantial risk of illness or injury of ESDs for SIB or AB.

We are proposing to amend part 895 by adding § 895.105 to ban ESDs for SIB or AB. The proposed rule would ban ESDs intended to treat patients with SIB or AB and would cause ESDs intended for these uses not to be legally marketed devices, for example, under section 1006 of the FD&C Act. We are also proposing conforming edits to § 882.5235 to exclude ESDs for SIB or AB from the class II designation for aversive conditioning devices and instead to indicate that ESDs for SIB or AB are banned devices.

FDA is proposing to ban ESDs that apply a noxious electrical stimulus to a person's skin to reduce or stop aggressive or self-injurious behavior. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. FDA is not proposing to ban ESDs intended for other purposes, such as smoking cessation. ESDs are not used in electroconvulsive therapy, sometimes called electroshock therapy or ECT, which is unrelated to this rulemaking.

Note that, although ESDs for SIB or AB may have parallels in technology and behavior modification strategy as ESDs for other intended uses, ESDs for SIB or AB are distinguishable from other ESDs based on several factors. These factors include device design; whether patients have control over the shocks and what level of control they have; the power output and resulting intensity of the electric shock; and how the electric shock affects the patient, target behavior, and underlying conditions. For example, a smoking cessation device would generally have different output characteristics, resulting in a less noxious (perhaps non-painful) shock, where the person affected by the shock retains complete control of application of shocks (or could immediately revoke consent to the application of shocks). Use of such a device without modification for SIB or AB would not be expected to induce a response for SIB or AB.

In contrast, patients exhibiting SIB or AB have no control over devices intended for these uses and these devices often deliver a painful or very painful shock, strong enough to induce fear and other reactions, as opposed to a milder shock from other ESDs. The SIB or AB patient is made to carry a stimulus generation module in a waist-pack or backpack 24 hours a day, 7 days a week, except during attempts to “fade” the device (although the user, not the patient, still decides whether to apply and trigger the device). Depending on the targeted behavior, ESDs for SIB or AB use up to five electrodes strapped to the arms, legs, torso, and/or feet simultaneously, but the locations are not of the patient's choosing (see Ref. 7). Shocks are from one electrode at a time, and the electrodes are rotated every hour or after discharge, but the patients are not able to dictate the rotation for themselves (see Ref. 7). Patients subject to ESDs for SIB or AB also have no control over whether to withdraw from treatment. Even for patients with mild to no intellectual disabilities, evidence indicates that assent from the patient is not sought (see Ref. 7). As explained in the 2020 Final Rule, lack of control over multiple shocks is an additional risk factor because learned helplessness may be more likely when the recipient does not have control over the shocks and has previously received multiple shocks (85 FR 13312 at 13326). When the recipient does not have control over the shocks and has previously received multiple such shocks, psychological trauma such as an anxiety or panic reaction can result even when the strength is relatively modest (see 85 FR 13312 at 13324 through 13327).

Moreover, as explained in the 2020 Final Rule, devices with similar technology intended for other uses address different conditions or behaviors in different patient populations, and as a result, they present different benefit-risk profiles. A device that presents certain risks or benefits for one population may not present the same risks or benefits, or present them to the same degree, or may present different risks or benefits, for a different population. An important consideration in the benefit-risk profile of a device is the intended patient population and their vulnerabilities. The intended use population for ESDs for SIB or AB includes a significant number of individuals who have disabilities that present vulnerabilities, such as difficulty communicating pain and other harms caused by ESDs. As a result of these vulnerabilities, the individual may not communicate or be able to communicate information for the device user to change the manner in which the device is used to correct or eliminate the risks (85 FR 13312 at 13344). In addition, people who exhibit SIB or AB may not be able to associate cause and effect or, as with some people with an autism spectrum disorder (ASD), they may express pain atypically or not at all (85 FR 13312 at 13317). These vulnerabilities are not likely to be present in people who use ESDs for other purposes. As a result, individuals subject to shocks from an ESD for SIB or AB would bear a higher risk of injury or illness from the shock than, for example, smokers who choose to use an ESD to help quit smoking (81 FR 24386 at 24395). Smokers can immediately communicate pain to the device's controller or remove the device themselves. They can communicate symptoms of other harms that may be caused by ESDs to their healthcare provider, which may lead to discontinuation of the device's use, or they can decide to stop using the device (85 FR 13312 at 13317).

FDA is proposing that the ban apply to devices already in commercial distribution and use, as well as devices sold or commercially distributed in the future (see § 895.21(d)(7)). This means ESDs for SIB or AB currently in use on individuals would be subject to the ban and thus, upon the effective date of the final rule, adulterated under section 501(g) of the FD&C Act and subject to potential FDA enforcement action. FDA is proposing this because the risk of illness or injury to individuals on whom these devices are already used is just as unreasonable and substantial as it is for future individuals on whom these devices could be used. Indeed, as the development of more beneficial, lower-risk alternative treatments continues, the ban's mitigation of the substantial and unreasonable risk may be greatest for the individuals on whom ESDs are currently used.

However, as explained in the 2020 Final Rule, for devices already in use for SIB or AB, in light of concerns about thorough assessments of the behaviors' functions and corresponding development of appropriate treatment plans, FDA recognizes that affected parties may need some period of time to establish or adjust treatment plans (85 FR 13312 at 13349). FDA believes that transition off ESDs should occur under the supervision of a physician and that the transition should occur as soon as possible for the individual. FDA is proposing, for devices in use on specific individuals as of the date of publication of any final rule based on this proposal, and subject to a physician-directed transition plan, compliance would be required 180 days after the date of publication of any final rule. We welcome comment on how long transitions may take.

We are proposing conforming edits to paragraph (b) of § 882.5235 to exclude ESDs for SIB or AB from the classification of aversive conditioning devices into class II. This amendment would indicate that ESDs for SIB or AB are banned devices rather than class II devices.

FDA proposes that any final rule based on this proposed rule be effective 30 days after its date of publication in the Federal Register .

FDA proposes that, for devices in use on specific individuals as of the date of publication of the final rule and subject to a physician-directed transition plan, compliance be required 180 days after the date of publication of the final rule in the Federal Register . For all other devices, FDA proposes that compliance be required 30 days after publication in the Federal Register .

We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, Executive Order 14094, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

Executive Orders 12866, 13563, and 14094 direct us to assess all benefits, costs, and transfers 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, and other advantages; distributive impacts; and equity). Rules are “significant” under Executive Order 12866 Section 3(f)(1) (as amended by Executive Order 14094) if they “have an annual effect on the economy of $200 million or more (adjusted every 3 years by the Administrator of [the Office of Information and Regulatory Affairs (OIRA)] for changes in gross domestic product); or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities.” OIRA has determined that this proposed rule is not a significant regulatory action under Executive Order 12866 Section 3(f)(1).

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the proposed rule would only affect one entity—one that is not classified as small—we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes estimates of anticipated impacts, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The 2022 threshold after adjustment for inflation is $177 million, using the 2022 Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.

The proposed rule, if finalized, would ban ESDs used for self-injurious or aggressive behavior. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling or a change in labeling. The proposed rule would apply to devices already in distribution and use, as well as to future sales and commercial distribution of these devices. The costs associated with this proposed rule include costs of individuals who are subject to the device if they move to another facility or another program within the affected entities. Affected entities, who use the device on such individuals, would also incur costs from reading and understanding the rule. The present value of total estimated costs range between $0.00 million and $68.93 million at a 7 percent discount rate, with a primary estimate of $34.47 million. At a 3 percent discount rate, the present value of costs range between $0.00 million and $80.59 million, with a primary estimate of $40.3 million. We estimate that the annualized costs over 10 years would range from $0.00 million to $9.17 million with a primary estimate of $4.59 million at a 7 percent discount rate and a 3 percent discount rate.

The benefits would include avoided negative physical and psychological effects from using ESDs on individuals and benefits to society in terms of protecting vulnerable populations, which we are not able to quantify. We estimate that between 51 to 54 individuals would be affected by the proposed rule, if finalized, and benefit from avoided adverse effects associated with using ESDs. Any transfers associated with the rule would occur if individuals enroll at facilities other than the affected entities. The present value of total transfer ranges between $0.00 million and $118.26 million at a 7 percent discount rate, with a primary estimate of $59.13 million. At a 3 percent discount rate, the present value of transfers ranges between $0.00 million and $138.26 million, with a primary estimate of $69.13 million. The annualized value of transfers range between $0.00 million and $15.74 million, with a primary estimate of $7.87 million, at both 7 percent and 3 percent discount rates. We provide a summary of the benefits, costs, and transfers of the proposed rule, if finalized, in table 1. We request comment on our estimates of benefits, costs, and transfers of this proposed rule.

The USPTO publishes this notice of proposed rulemaking (NPRM or proposed rule) under section 10 of the AIA (section 10), Public Law 112-29, 125 Stat. 284, as amended by the SUCCESS Act, Public Law 115-273, 132 Stat. 4158, which authorizes the Under Secretary of Commerce for Intellectual Property and Director of the USPTO to set or adjust by rule any trademark fee established, authorized, or charged under the Trademark Act of 1946 (the Trademark Act), 15 U.S.C. 1051 et seq., as amended, for any services performed or materials furnished by the agency. Section 10 prescribes that trademark fees may be set or adjusted only to recover the aggregate estimated costs to the USPTO for processing, activities, services, and materials relating to trademarks, including administrative costs of the agency with respect to such trademark fees. Section 10 authority includes flexibility to set individual fees in a way that furthers key policy factors, while considering the cost of the respective services. Section 10 also establishes certain procedural requirements for setting or adjusting fee regulations, such as public hearings and input from the Trademark Public Advisory Committee (TPAC) and congressional oversight. TPAC held a public hearing on the USPTO's preliminary trademark fee proposals on June 5, 2023, and issued a report (TPAC Report) on August 14, 2023, containing its comments, advice, and recommendations on the preliminary fee proposals. The USPTO considered and analyzed the TPAC Report before publishing the fee proposals in this NPRM. See Part IV: Rulemaking Goals and Strategies for further discussion of the TPAC Report.

Based on a biennial review of fees, costs, and revenues that began in fiscal year (FY) 2021, the USPTO concluded that fee adjustments are necessary to provide the agency with sufficient financial resources to facilitate the effective administration of the U.S. trademark system, including implementing the Strategic Plan, available on the agency website at https://www.uspto.gov/StrategicPlan. The individual fee proposals align with the USPTO's fee structure philosophy, including the agency's four key fee setting policy factors: (1) promote innovation strategies; (2) align fees with the full cost of trademark services; (3) set fees to facilitate the effective administration of the trademark system; and (4) offer application processing options. The proposed fee adjustments will enable the USPTO to accomplish its mission to drive U.S. innovation, inclusive capitalism, and global competitiveness by delivering high-quality and timely trademark examination and review proceedings that produce accurate and reliable trademark rights for domestic and international stakeholders.

The USPTO proposes to set and adjust 31 trademark fees, including the introduction of 12 new fees. The agency also proposes discontinuing 6 fees.

Under the proposed fee schedule in this NPRM, the routine fees to obtain and maintain a trademark registration ( e.g., application filing, intent-to-use/use (ITU) filings, and post-registration maintenance fees) will increase relative to the current fee schedule, in order to ensure financial sustainability and provide for improvements needed relative to trademark filings and registration. Additional information describing the proposed fee adjustments is included in Part V: Individual Fee Rationale in this rulemaking and in the Table of Trademark Fees—Current, Proposed, and Unit Cost (Table of Trademark Fees), available on the fee setting section of the USPTO website at https://www.uspto.gov/FeeSettingAndAdjusting.

The AIA was enacted on September 16, 2011. See Public Law 112-29, 125 Stat. 284, 316-17. Section 10(a) of the AIA authorizes the Director of the USPTO (Director) to set or adjust by rule any fee established, authorized, or charged under the Trademark Act for any services performed or materials furnished by the agency. Section 10 provides that trademark fees may be set or adjusted only to recover the aggregate estimated costs to the USPTO for processing, activities, services, and materials relating to trademarks, including administrative costs of the agency with respect to such trademark fees. Provided that the fees in the aggregate achieve overall aggregate cost recovery, the Director may set individual fees under section 10 at, below, or above their respective cost. Section 10(e) requires the Director to publish the final fee rule in the Federal Register and the USPTO's Official Gazette at least 45 days before the final fees become effective.

The SUCCESS Act was enacted on October 31, 2018. See Public Law 115-273, 132 Stat. 4158. Section 4 of the SUCCESS Act amended section 10(i)(2) of the AIA by striking “7-year” and inserting “15-year” in reference to the expiration of fee setting authority. Therefore, updated section 10(i) terminates the Director's authority to set or adjust any fee under section 10 upon the expiration of the 15-year period that began on September 16, 2011, and ends on September 16, 2026.

The Secretary of Commerce established TPAC under the American Inventors Protection Act of 1999. TPAC advises the Director of the USPTO on the management, policies, goals, performance, budget, and user fees of trademark operations.

When adopting fees under section 10 of the AIA, the Director must provide the proposed fees to TPAC at least 45 days prior to publishing the proposed fees in the Federal Register . TPAC then has 30 days within which to deliberate, consider, and comment on the proposal, as well as hold a public hearing on the proposed fees. Then, TPAC must publish a written report setting forth in detail the comments, advice, and recommendations of the committee regarding the proposed fees. The USPTO must consider and analyze any comments, advice, or recommendations received from TPAC before setting or adjusting fees.

Accordingly, on May 8, 2023, the Director notified TPAC of the USPTO's intent to set and adjust trademark fees and submitted a preliminary trademark fee proposal with supporting materials. The preliminary trademark fee proposal and associated materials are available on the fee setting section of the USPTO website at https://www.uspto.gov/FeeSettingAndAdjusting.

TPAC held a public hearing at the USPTO's headquarters in Alexandria, Virginia, on June 5, 2023, and members of the public were given an opportunity to provide oral testimony. Transcripts of the hearing are available for review on the USPTO website at https://www.uspto.gov/sites/default/files/documents/TPAC-Fee-Setting-Hearing-Transcript-20230605.pdf. Members of the public were also given an opportunity to submit written comments for TPAC to consider, and these comments are available on Regulations.gov at https://www.regulations.gov/docket/PTO-T-2023-0016. On August 14, 2023, TPAC issued a written report setting forth their comments, advice, and recommendations regarding the preliminary proposed fees. The report is available on the USPTO website at https://www.uspto.gov/sites/default/files/documents/TPAC-Report-on-2023-Fee-Proposal.docx. The USPTO considered and analyzed all comments, advice, and recommendations received from TPAC before publishing this NPRM. See Part IV: Rulemaking Goals and Strategies for further discussion of the TPAC Report.

Section 10 provides that trademark fees may be set or adjusted only to recover the aggregate estimated costs to the USPTO for processing, activities, services, and materials relating to trademarks, including administrative costs with respect to such trademark fees. The following is a description of how the agency estimates aggregate costs and revenue.

Estimating prospective aggregate costs is accomplished primarily through the annual budget formulation process. The annual budget is a five-year plan for carrying out base programs and new initiatives to deliver on the USPTO's statutory mission and implement the agency's strategic goals and objectives.

First, the USPTO projects the level of demand for trademark services, which depends on many factors that are subject to change, including domestic and global economic activity. The agency also considers non-US trademark-related activities, policies, and legislation, and known process efficiencies. The number of trademark application filings ( i.e., incoming work to the USPTO) drives examination costs, which make up the largest share of trademark operating costs. The USPTO looks at indicators including the expected growth in real gross domestic product (RGDP), a leading indicator of incoming trademark applications, to estimate prospective workloads. RGDP is reported by the Bureau of Economic Analysis ( www.bea.gov ) and forecasted each February by the Office of Management and Budget (OMB) ( www.omb.gov ) in the Economic and Budget Analyses section of the Analytical Perspectives, and twice annually by the Congressional Budget Office (CBO) ( www.cbo.gov ) in the Budget and Economic Outlook.

The expected production workload is then compared to the current examination production capacity to determine any required staffing and operating costs ( e.g., salaries, workload processing contracts, and publication) adjustments. The agency uses a trademark pendency model that estimates trademark production output based on actual historical data and input assumptions, such as incoming trademark applications, number of examining attorneys on board, and overtime hours. Key statistics regarding pendency, filing and application metrics, and current inventory used to inform the model can be viewed on the data visualization center section of the USPTO website at https://www.uspto.gov/dashboard/trademarks.

Next, the USPTO calculates budgetary spending requirements based on the prospective aggregate costs of trademark operations. First, the agency estimates the costs of status quo operations (base requirements), then adjusts that figure for anticipated pay increases and inflationary increases for the budget year and four out years. The USPTO then estimates the prospective costs for expected changes in production workload and new initiatives over the same period. The agency then reduces cost estimates for completed initiatives and known cost savings expected over the same five-year horizon. A detailed description of budgetary requirements, aggregate costs, and related assumptions for the Trademarks program is available in the FY 2025 Budget.

The USPTO estimates that trademark operations will cost $594 million in FY 2025, including $293 million for trademark examining; $24 million for trademark trials and appeals; $50 million for trademark information resources; $22 million for activities related to intellectual property (IP) protection, policy, and enforcement; and $204 million for general support costs necessary for trademark operations ( e.g., the trademark share of rent, utilities, legal, financial, human resources, other administrative services, and agency-wide information technology (IT) infrastructure and support costs). See Appendix II of the FY 2025 Budget. In addition, the agency will transfer $280 thousand to the Department of Commerce, Inspector General, for audit support for the Trademarks program.

Table 1 below provides key underlying production workload projections and assumptions from the FY 2025 Budget used to calculate aggregate costs. Table 2 (see Step 2) presents the total budgetary requirements (prospective aggregate costs) for FY 2025 through FY 2029 and the estimated collections and operating reserve balances that would result from the proposed adjustments contained in this NPRM. These projections are based on point-in-time estimates and assumptions that are subject to change. There is considerable uncertainty in outyear budgetary requirements. There are risks that could materialize over the next several years ( e.g., adjustments to examination capacity, time allotted to examining attorneys and other personnel to perform their work, recompetitions of contracts, changes in workload, and inflationary increases, etc.) that could increase the USPTO's budgetary requirements in the short- to medium-term. These estimates are refreshed annually during the formulation of USPTO's budget.

As described above in Step 1, the USPTO's prospective aggregate costs (as presented in the FY 2025 Budget) include budgetary requirements related to planned production, anticipated initiatives, and a contribution to the trademark operating reserve required for the agency to maintain trademark operations and realize its strategic goals and objectives for the next five years. Prospective aggregate costs become the target aggregate revenue level that the new fee schedule must generate in a given year and over the five-year planning horizon. To estimate aggregate revenue, the USPTO references production models used to estimate aggregate costs and analyzes relevant factors and indicators to calculate prospective fee workloads ( e.g., number of applications and requests for services and products).

The same economic indicators used to forecast incoming workloads also provide insight into market conditions and the management of IP portfolios, which influence application processing requests and post-registration decisions to maintain trademark protection. When developing fee workload forecasts, the USPTO also considers other factors including fraud and scams impacting trademark filings, overseas activity, policies and legislation, court decisions, process efficiencies, and anticipated applicant behavior.

The USPTO collects fees for trademark-related services and products at different points in time within the application examination process and over the life of the pending trademark application and resulting registration. Trademark application filings are a key driver of trademark fee collections, as initial filing fees account for more than half of total trademark fee collections. Changes in application filing levels immediately impact current year fee collections because fewer application filings mean the USPTO collects fewer fees to devote to production-related costs. The resulting reduction in production activities also creates an outyear revenue impact because less production output in one year leads to fewer ITU and maintenance fee payments in future years. Historically, fee collections from ITU and maintenance fees account for about one third of total trademark fee collections, which the agency uses to subsidize costs for filing and examination activities not fully covered by initial filing fees.

The USPTO's five-year estimated aggregate trademark fee revenue (see Table 2) is based on, for each fiscal year, the number of trademark applications it expects to receive, work it expects to process (an indicator of the ITU fee workloads), expected examination and process requests, and the expected number of post-registration filings to maintain trademark registrations. The USPTO forecasts the same number of future year applications filed under the proposed fee schedule compared to the current fee schedule because outside research suggests that demand for trademark applications is inelastic. The USPTO does anticipate a larger share of filers will take measures to avoid the proposed surcharges compared to the share of filers that take advantage of the TEAS Plus option under the current fee schedule. The USPTO's Office of the Chief Economist periodically conducts economic studies and may, in the future, develop trademark fee price elasticity estimates for use in rulemakings.

Within the iterative process for estimating aggregate revenue, the USPTO adjusts individual fee rates up or down based on cost and policy decisions, estimates the effective dates of new fee rates, and then multiplies the resulting fee rates by appropriate workload volumes to calculate a revenue estimate for each fee. In the aggregate revenue estimates presented below, the agency assumes that all proposed fee rates will become effective on November 15, 2024. Using these figures, the USPTO sums the individual fee revenue estimates, and the result is a total aggregate revenue estimate for a given year (see Table 2). The aggregate revenue estimate also includes collecting $10 million annually in other income associated with recoveries and reimbursements from other Federal agencies (offsets to spending).

The strategy of this proposed rule is to establish a fee schedule that generates sufficient multi-year revenue to recover the aggregate costs of maintaining USPTO trademark operations. The overriding principles behind this strategy are to operate within a sustainable funding model that supports the USPTO's strategic goals and objectives, such as optimizing trademark application pendency through the promotion of efficient operations and filing behaviors, issuing accurate and reliable trademark registrations, and encouraging access to the trademark system for all stakeholders.

The USPTO assessed this proposed rule's alignment with four key fee setting policy factors that promote a particular aspect of the U.S. trademark system. (1) Promoting innovation strategies seeks to ensure barriers to entry into the U.S. trademark system remain low, encourage high-growth and innovation-based entrepreneurship, and incentivize innovation and entrepreneurship by issuing registrations to stimulate additional entrepreneurial activity. (2) Aligning fees with the full costs of products and services recognizes that some applicants may use particular services in a more costly manner than other applicants ( e.g., trademark applications cost more and take longer to examine when identifications of goods and services include thousands of characters), and charges those applicants appropriately rather than sharing the costs among all applicants. (3) Facilitating the effective administration of the trademark system seeks to encourage efficient prosecution of trademark applications, reducing the time it takes to obtain a registration. (4) Offering application processing options provides multiple paths, where feasible, in recognition that trademark prosecution is not a one-size-fits-all process. The reasoning for setting and adjusting individual fees is described in Part V: Individual Fee Rationale.

The balance of this sub-section presents the specific fee setting considerations the USPTO reviewed in developing the proposed trademark fee schedule: (1) historical cost of providing individual services; (2) the balance between projected costs and revenue to meet the USPTO's operational needs and strategic goals; (3) ensuring sustainable funding; and (4) TPAC's comments, advice, and recommendations on the USPTO's initial fee setting proposal. Collectively, these considerations informed the USPTO's chosen rulemaking strategy.

The USPTO sets individual fee rates to further key policy considerations while considering the cost of a particular service. For instance, the USPTO has a longstanding practice of setting application filing fees below the actual cost of processing and examining applications to encourage brand owners to take advantage of the protections and rights offered by trademark registration.

The USPTO considers unit cost data provided by its Activity Based Information (ABI) program to decide how to best align fees with the full cost of products and services. Using historical cost data, the USPTO can align fees to the costs of specific trademark products and services. When the USPTO implements a new process or service, historical activity-based information (ABI) data is typically not available. However, the USPTO will use the historical cost of a similar process or procedure as a starting point to estimate the full cost of a new activity or service.

The document entitled “USPTO Setting and Adjusting Trademark Fees During Fiscal Year 2025—Activity Based Information and Trademark Fee Unit Expense Methodology,” available on the fee setting section of the USPTO website at https://www.uspto.gov/FeeSettingAndAdjusting, provides additional information on the agency's costing methodology in addition to the last three years of historical cost data. Part V: Individual Fee Rationale of this proposed rule describes the reasoning and anticipated benefits for setting some individual fees at cost, below cost, or above cost such that the USPTO recovers the aggregate cost of providing services through fees.

In developing the proposed trademark fee schedule, the USPTO considered its current estimates of future year workload demands, fee collections, and costs to maintain core USPTO operations and meet its strategic goals, as found in the FY 2025 Budget and the Strategic Plan. The USPTO's strategic goals include: (1) driving inclusive U.S. innovation and global competitiveness; (2) promoting the efficient delivery of reliable IP rights; (3) promoting the protection of IP against new and persistent threats; (4) bringing innovation to impact; and (5) generating impactful employee and customer experiences by maximizing agency operations. The following subsections provide details regarding updated revenue and cost estimates, cost saving efforts taken by the USPTO, and planned strategic improvements.

Projected revenue from the current fee schedule is insufficient to meet future budgetary requirements (costs) due largely to lower-than-expected demand for trademark services compared to prior forecasts and higher-than-expected inflation in the broader U.S. economy that has increased the USPTO's operating costs. Consequently, aggregate operating costs will exceed aggregate revenue for the Trademarks program under the current schedule. Absent the proposed increase in fees or an unsustainable reduction in operating costs, the USPTO would deplete its operating reserves and significantly increase financial risk.

Forecasts for aggregate revenue using current demand estimates are lower than prior forecasts. This lower-than-expected demand has coincided with changes to trademark owners' filing and renewal patterns, resulting in some imbalances in the overall fee structure. The USPTO sets application filing fees below its examination costs to maintain a low barrier to entry into the trademark registration system and relies on fees collected for post-registration maintenance and ITU extensions to subsidize the agency's losses on each application examined. However, changes in the mix of filers and their preferences have upset the traditional balance of the trademark fee structure. The share of applicants filing ITU applications is declining. Also, the percentage of registrants that choose to maintain their trademark registration is declining as a larger share of filers are groups that are historically less likely to renew their registrations at a rate that would be sufficient to recover examination costs. The USPTO believes these changes in the mix of filers are systemic and will continue.

Following an unprecedented application surge in FY 2021, trademark application filings declined and began returning to historic filing levels in FY 2022, in line with the USPTO's expectations. Application filings were largely unchanged in FY 2023. Given the current economic outlook for the broader economy and filing activity over the past two years, the USPTO projects trademark application filings to decline slightly in FY 2024 and increase in line with historic growth rates in FY 2025.

Higher-than-expected inflation starting in 2021 in the broader U.S. economy increased the USPTO's operating costs above previous estimates for labor and nonlabor activities such as benefits, service contracts, and equipment. Salaries and benefits comprise about two-thirds of all trademark-related costs, and employee pay raises enacted across all U.S. government agencies in FY 2023-24—including the USPTO—were much larger than previously budgeted. Federal General Schedule (GS) pay was raised by 4.6% in 2023 and 5.2% in 2024; before 2023 the last time GS pay was raised by at least 4% was in 2004. The FY 2025 Budget includes an estimated 2.0% civilian pay raise planned in calendar year (CY) 2025 and assumed 3.0% civilian pay raises in CY 2026-29, as well as inflationary increases for other labor and nonlabor activities.

The USPTO recognizes that fees cannot simply increase for every improvement deemed desirable. The USPTO has a responsibility to stakeholders to pursue strategic opportunities for improvement in an efficient, cost-conscious manner. Likewise, the USPTO recognizes its obligation to reduce spending when appropriate.

The USPTO's FY 2025 Budget submission includes cost reducing measures such as releasing leased space in Northern Virginia and a moderate reduction in overall IT spending. In FY 2025, the USPTO estimates $4,569 million in total spending for patent and trademark operations. This is a $122 million net increase from the agency's FY 2024 estimated spending level of $4,447 million. The net increase includes a $224 million upward adjustment for prescribed inflation and other adjustments, and a $102 million downward adjustment in program spending and other realized efficiencies. This estimate builds on the $40 million in annual real estate savings assumed in the FY 2024 Budget submission to include additional annual cost savings of $12 million through releasing more leased space in Northern Virginia. The combined reduction in real estate space amounts to almost 1 million square feet and an estimated annual cost savings of approximately $52 million. Also, the USPTO is actively pursuing IT cost containment. The FY 2025 budget includes a relatively flat IT spending profile despite upward pressure from inflation, supply chain disruptions, and government-wide pay raises; ongoing IT improvements that offer business value to fee-paying customers; and data storage costs increasing proportionally with the USPTO's forecasted growth in patent and trademark applications. The USPTO will achieve this cost containment goal via modern equipment in a new data center that will cost less to maintain and by retiring legacy IT systems. These cost containment measures will also improve the USPTO's cybersecurity posture and increase system resiliency.

The USPTO's strategic goal to “promote the efficient delivery of reliable IP rights” recognizes the importance of innovation as the foundation of American economic growth and global competitiveness. Toward this end, the USPTO is committed to continuously improving trademark quality, as well as the accuracy and reliability of the trademark register. The agency will continue equipping trademark examining attorneys with updated tools, procedures, and clarifying guidance to effectively examine all applications. The USPTO will also retire legacy systems and integrate the use of emerging technologies to streamline work processes for greater efficiencies; adjust staffing levels; and refine core duties to ensure its ability to meet significant changes in filing volumes and a variety of improper filing behaviors.

The USPTO is also committed to improving trademark application pendency. The agency recognizes that applying for trademark registration is a key step for creators, entrepreneurs, and established brand owners as they move from generating ideas for new products and services to commercializing the resulting innovations in the marketplace. The USPTO is focused on incentivizing creativity and product innovation by removing unnecessary impediments or delays in securing IP rights, thereby bringing goods and services to impact for the public good more quickly.

The agency's recent trademark pendency challenge is the result of several years of sustained increases in trademark application filings punctuated by an unprecedented, year-long influx during FY 2021 that created a significant examination backlog. In addressing these challenges, the USPTO will: (1) reevaluate its operating posture to maximize efficiency; (2) set data-driven pendency goals; (3) realign the trademark workforce to maintain stability during workload fluctuations and optimize pendency goals; and (4) use available technology solutions to streamline and automate trademark work processes.

The agency is working diligently to balance timely examination with trademark quality. Improvements include the deployment of a new browser-based, end-to-end examination system (TM Exam) designed to improve examination quality and efficiency, and establishment of a dedicated Trademark Academy to improve the training experience for new examiners.

The USPTO is also developing and implementing several strategies to combat IP violations and protect the Trademark Register via legislation, IT enhancements, and tactical management programs. For example, the agency is implementing robotic process automation to validate trademark application addresses against the U.S. Postal Service's database, mitigating a key fraud risk. In addition, the USPTO recently formed the Register Protection Office (RPO), a new organization within the Office of the Deputy Commissioner for Trademark Examination Policy dedicated to register protection through efforts like scam education and prevention.

The USPTO is also leveraging Trademark Modernization Act (TMA) cancellation provisions to help clear the Trademark Register of registrations not in use. See Public Law 116-260. The agency implemented the TMA nonuse cancellation provisions in December 2021, and in December 2022, implemented additional provisions that shortened the applicant response period for office actions from six to three months. See Changes To Implement Provisions of the Trademark Modernization Act of 2020, 86 FR 64300 (Nov. 17, 2021). The USPTO will finish implementing the TMA in spring or early summer 2024, when additional provisions to shorten the period for registrants to respond to post-registration office actions from six to three months take effect. See Changes To Implement Provisions of the Trademark Modernization Act of 2020; Delay of Effective Date, 88 FR 62463 (Sep. 12, 2023).

The USPTO is also committed to generating impactful employee and customer experiences by maximizing agency operations. The USPTO strives to be a model employer through its diversity, equity, inclusion, and accessibility (DEIA) practices. The agency will build upon its existing diversity and foster greater inclusion to empower the USPTO workforce to serve the IP community successfully. To accomplish this, the USPTO will research and implement leading-edge practices related to hiring, development, advancement, accessibility, and retention, based on behavioral science research and data, to better integrate DEIA practices throughout the agency.

The USPTO recognizes that its core operating costs may increase in future years as the agency works to reduce trademark pendency, improve examination processes, enhance trademark quality and accuracy, and protect entrepreneurs and innovators from fraud.

The USPTO's five-year forecasts of aggregate trademark costs, aggregate trademark revenue, and the trademark operating reserve are inherently uncertain. The Government Accountability Office (GAO) recommends operating reserves as a best practice for fee-funded agencies like the USPTO, and the trademark operating reserve allows the agency to align long-term fees and costs and manage fluctuations in actual fee collections and spending.

The USPTO manages the trademark operating reserve within a range of acceptable balances and assesses options when projected balances fall either below or above the range. The agency develops minimum planning targets to address immediate, unplanned changes in the economic or operating environment as the reserve builds toward the optimal level. The USPTO reviews both its minimum and optimal planning targets every three years to ensure the reserve's operating range mitigates an array of financial risks. Based on the current risk environment, including various factors such as economic and funding uncertainty and the Trademarks program's high percentage of fixed costs, the agency recently established a minimum operating reserve planning level at 23% of total spending—about three months' operating expenses (estimated at $137 million and $159 million from FY 2025 through FY 2029)—and an optimal long-range target of 50% of total spending—about six months' operating expenses (estimated at $297 million and $345 million from FY 2025 through FY 2029).

Based on cost and revenue assumptions in the FY 2025 Budget, the USPTO forecasts that aggregate trademark costs will exceed aggregate trademark revenue during FY 2024. The agency will finance the shortfall in trademark operations via the trademark operating reserve. The USPTO projects that the fee proposals contained in this NPRM will increase trademark fee collections to sufficiently recover budgeted spending requirements; modest fee collections above budgeted spending requirements will replenish and grow the operating reserve each year from FY 2025 to FY 2029.

These projections are point-in-time estimates and subject to change. For example, the FY 2025 Budget includes assumptions regarding filing levels, renewal rates, federally mandated employee pay raises, workforce productivity, and many other factors. A change in any one of these variables could have a significant cumulative impact on the trademark operating reserve balance. As shown in Table 2, presented in Part III: Estimating Aggregate Costs and Revenue, the operating reserve balance can change significantly over a five-year planning horizon. This highlights the agency's financial vulnerability to various risk factors and the importance of its fee setting authority.

The USPTO will continue assessing the trademark operating reserve balance against its target balance annually, and at least every three years, the agency will evaluate whether the minimum and optimal target balances remain sufficient to provide stable funding. Per USPTO policy, the agency will consider fee reductions if projections show the operating reserve balance will exceed its optimal level by 25% for two consecutive years. In addition, the USPTO will continue to regularly review its operating budgets and long-range plans to ensure the prudent use of trademark fees.

In its report prepared in accordance with the AIA fee setting authority, TPAC conveyed overall support for the USPTO's efforts to secure adequate revenue to recover the aggregate estimated costs of trademark operations. Specifically, the report states, “[w]e [TPAC] have no doubt that overall increases are needed to ensure that the USPTO complies with its statutory mandate to set fees at a level commensurate with anticipated aggregate costs.” TPAC Report at 3. TPAC also expressed general support for the USPTO's stated goals and methods for achieving aggregate cost recovery but was concerned about some individual fee adjustments and their potential impacts on trademark applicants and owners. This NPRM includes additional information that addresses these comments and additional feedback from the public.

TPAC expressed support for the proposed adjustments to application filing fees but noted that many public comments centered on proposed surcharges. TPAC asked the USPTO to consider how it will implement any surcharges and whether entity discounts may be possible. To address these concerns, the USPTO includes in this NPRM: (1) information on specific deficiencies that will trigger the insufficient information surcharge; (2) additional details that explain the agency's rationale for the Custom ID proposal; and (3) additional details regarding the ID character limit proposal. See Part V: Individual Fee Rationale for additional details. With respect to entity discounts, section 10(a) of the AIA authorizes the Director to set or adjust any fee established, authorized, or charged under the Trademark Act but, but it does not include the authority to provide entity discounts for trademark fees.

TPAC supported proposed fee increases for filing an amendment to allege use (AAU) and statement of use (SOU) but recommended that the USPTO modify the initial proposal to make the AAU fee less than the SOU fee to “better align incentives for efficiency, because fewer resources are required to process an AAU.” TPAC Report at 5. Based on this recommendation, the USPTO proposes setting the fees for both an AAU and SOU at $150. While the agency incurs different processing costs for these services, they have historically had identical fee rates; maintaining this symmetry will alleviate potential confusion among stakeholders and future USPTO customers.

TPAC did not support increased fees for fourth and fifth extensions of time to file an SOU. The committee stated that filers in highly regulated industries with long product launch timelines, as well as resource-constrained startups and small businesses, often need additional extensions. Weighing the need for timely ITU decisions against potential adverse impacts on innovators and small filers, the USPTO has opted to not further pursue this proposal.

TPAC expressed a general lack of support for increasing fees for renewals, declarations of use, and declarations of incontestability. TPAC is concerned the proposed increases could discourage registrants from maintaining their registrations and will likely lead to more common law investigations and higher clearance costs for many trademark owners. The USPTO acknowledges these concerns. However, the agency has an obligation to recover the aggregate costs of trademark operations through user fees, and above-cost post-registration maintenance fees recover costs incurred by the USPTO during examination. The share of applications from groups that have been historically less likely to maintain their registrations has increased. Therefore, the balance between aggregate revenue derived from application fees and post-registration maintenance fees must be adjusted to sustain low barriers to filing new applications.

Although TPAC did not favor higher maintenance fees in general, the committee offered support for increased fees for foreign and international registrants under sections 66, 44, and 71, noting that “[o]wners of these registrations have not been required to prove use prior to registration” and “are more likely to describe an excessive list of goods and services, to offer suspect specimens and declarations, and to require auditing.” TPAC Report at 6. TPAC recognized that such a proposal could “implicate many factors, including compliance with international treaty obligations.” TPAC Report at 6. The USPTO decided not to charge foreign or international registrants a higher fee than domestic registrants for these services. The agency notes that proposed and existing fees address some TPAC concerns regarding foreign and international registrants. All applications and registrants are subject to fees for deleting goods, services, and/or classes following a post-registration audit and would be subject to the proposed surcharge for each additional group of 1,000 characters.

TPAC supported the proposals for petitions to revive and petitions to the Director as justified and appropriate.

TPAC expressed support for the USPTO directly recovering a larger portion of the cost associated with processing letters of protest but objected to the size of the proposed fee increase, noting that most public commenters were opposed. TPAC recommended a smaller increase, given the perceived value of meritorious letters in the examination process and as a cost-effective mechanism for members of the public to provide information to examining attorneys. In response, the USPTO has revised the proposed letter of protest fee downward to $150. See Part V: Individual Fee Rationale for additional details.

In summary, the USPTO appreciates the overall support and advice provided by TPAC and stakeholders to increase trademark fees to recover aggregate cost. After careful consideration of the comments, concerns, and advice provided in the TPAC Report, and keeping in mind the goals of this proposed rule, the USPTO elected to adjust two fee proposals and drop one proposal. The proposed fee structure will allow the USPTO to maintain trademark operations and pursue the goals and objectives outlined in its Strategic Plan. The agency looks forward to receiving additional feedback on this revised proposal during the public comment period.

The USPTO estimates that the proposed trademark fee schedule will produce sufficient aggregate revenue to recover the aggregate costs of trademark operations and ensure financial sustainability for effective administration of the trademark system. This proposed rule aligns with the USPTO's four key fee setting policy factors and supports the agency's mission-focused strategic goals.

Where unit cost data is available, the USPTO sets some fees at, above, or below their unit costs to balance the agency's four key fee setting policy factors as described in Part IV: Rulemaking Goals and Strategies. The USPTO does not maintain individual historical cost data for all fees, and therefore some fees are set solely based on the policy factors. For example, the USPTO sets initial filing fees below unit cost to promote innovation strategies by reducing barriers to entry for applicants. To balance the aggregate revenue loss of fees set below cost, the USPTO must set other fees above unit cost in areas less likely to impact entrepreneurship ( e.g., renewal fees). By setting fees at particular levels to facilitate effective administration of the trademark system, the USPTO aims to foster an environment where examining attorneys can provide, and applicants can receive, prompt, high-quality examination decisions while recovering costs for workload-intensive activities.

This proposed rule maintains existing cost differentials for all paper filings; their processing is generally more costly than electronic submissions, and current fees do not recover these costs.

The USPTO is proposing changes to application filing fees to incentivize more complete and timely filings and improve prosecution. Trademark applicants currently have two filing options via the Trademark Electronic Application System (TEAS): TEAS Plus and TEAS Standard. TEAS Plus is the lowest-cost filing option currently provided by the USPTO but comes with more stringent initial filing requirements. These applications reduce manual processing and potential for data entry errors, making them more efficient and complete for both the filer and the agency. The USPTO incurs fewer costs and impediments during their examination, thereby expediting processing and reducing pendency. About half of all trademark applications are filed using TEAS Plus. TEAS Standard fees are higher than those for TEAS Plus and offer applicants more options during filing; the higher fees relate to the higher costs incurred by the USPTO in processing and examining the application.

The USPTO proposes implementing a single electronic application filing option with most of the same requirements as TEAS Plus and eliminating TEAS Standard. In effect, the proposed fee schedule would discontinue both TEAS Plus and TEAS Standard filing fees, as well as fees for failing to meet the requirements of a TEAS Plus application, replacing them with a single electronic filing option. Similar to TEAS, applicants willing to comply with the proposed requirements in their initial filing (comparable to TEAS Plus) will pay the lowest fees under the proposed fee schedule, compared to applicants who fail to meet all of those requirements (comparable to TEAS Standard). The USPTO does not anticipate the total number of applications filed each year will change under the proposed schedule compared to the current schedule. The USPTO does anticipate that a larger share of applicants will take measures to avoid the proposed surcharges compared to the share of applicants who use the TEAS Plus option under the current fee schedule. Applications that do not meet all requirements for the lowest cost electronic filing option are discussed below.

The proposed fee schedule sets the fee for a base application, filed electronically, at $350, $100 more than a TEAS Plus application, to help the agency recover its costs. The USPTO proposes increasing the paper application fee by $100 to maintain the existing cost differential between a paper filing and the lowest cost electronic application.

The USPTO proposes discontinuing current fees for filing an application under section 66(a) (Madrid Protocol) of the Trademark Act and setting new fees at $350 per class, as paid in Swiss francs to the World Intellectual Property Organization (WIPO), in line with the proposed base application fee under the new single electronic application filing option.

The USPTO proposes administrative revisions to the regulatory text in 37 CFR to incorporate the proposed base application fee and discontinuation of TEAS application fees. These proposed revisions include replacing references to “TEAS” and “ESTTA” with “electronically” in sections 2.6 and 7.6 to reflect the discontinuation of TEAS fees under this proposed rule. These generalized references for electronic filings are more dynamic and will more easily accommodate any future changes to the USPTO's electronic filing system.

The USPTO also proposes surcharges to the base application filing fee to enhance the quality of incoming applications, encourage efficient application processing, ensure additional examination costs are paid by those submitting more time-consuming applications, and reduce pendency. Only those applicants submitting applications that do not comply with the base filing requirements would pay the proposed surcharges. Compared to the current TEAS Standard fee that is charged for applications when one or more TEAS Plus requirements are not met, the proposed system would impose individual surcharges when certain requirements are not met.

Trademark applications that include the information listed below allow for more efficient prosecution. Accordingly, applicants who submit more complete applications benefit from the proposed fee schedule by avoiding this proposed surcharge, as the USPTO and its stakeholders benefit from efficient delivery of reliable IP rights. This proposed rule would impose a $100 fee per class, in addition to the base fee, on applications that do not include required information at the time of filing. The information required for a base application is similar to current TEAS Plus requirements and therefore applicants are not expected to expend more than a de minimis amount of additional resources compared to the current TEAS system. The USPTO proposes reordering and retitling these as “Requirements for a base application,” as provided in 37 CFR 2.22:

(1) The applicant's name and domicile address;

(2) The applicant's legal entity;

(3) The citizenship of each individual applicant, or the state or country of incorporation or organization of each juristic applicant;

(4) If the applicant is a domestic partnership, the names and citizenship of the general partners, or if the applicant is a domestic joint venture, the names and citizenship of the active members of the joint venture;

(5) If the applicant is a sole proprietorship, the state of organization of the sole proprietorship and the name and citizenship of the sole proprietor;

(6) One or more bases for filing that satisfy all the requirements of § 2.34. If more than one basis is set forth, the applicant must comply with the requirements of § 2.34 for each asserted basis;

(7) If the application contains goods and/or services in more than one class, compliance with § 2.86;

(8) A filing fee for each class of goods and/or services, as required by § 2.6(a)(1)(ii) or (iii);

(9) A verified statement that meets the requirements of § 2.33, dated and signed by a person properly authorized to sign on behalf of the owner pursuant to § 2.193(e)(1);

(10) If the applicant does not claim standard characters, the applicant must attach a digitized image of the mark. If the mark includes color, the drawing must show the mark in color;

(11) If the mark is in standard characters, a mark comprised only of characters in the Office's standard character set, typed in the appropriate field of the application;

(12) If the mark includes color, a statement naming the color(s) and describing where the color(s) appears on the mark, and a claim that the color(s) is a feature of the mark;

(13) If the mark is not in standard characters, a description of the mark;

(14) If the mark includes non-English wording, an English translation of that wording;

(15) If the mark includes non-Latin characters, a transliteration of those characters;

(16) If the mark includes an individual's name or likeness, either (i) a statement that identifies the living individual whose name or likeness the mark comprises and written consent of the individual, or (ii) a statement that the name or likeness does not identify a living individual (see section 2(c) of the Act);

(17) If the applicant owns one or more registrations for the same mark, and the owner(s) last listed in Office records of the prior registration(s) for the same mark differs from the owner(s) listed in the application, a claim of ownership of the registration(s) identified by the registration number(s), pursuant to § 2.36;

(18) If the application is a concurrent use application, compliance with § 2.42;

(19) An applicant whose domicile is not located within the United States or its territories must designate an attorney as the applicant's representative, pursuant to § 2.11(a), and include the attorney's name, postal address, email address, and bar information; and

(20) Correctly classified goods and/or services, with an identification of goods and/or services from the Office's Acceptable Identification of Goods and Services Manual within the electronic form.

See Part VI: Discussion of Specific Rules for more information.

The agency will not impose this fee on applications denied a filing date for failure to satisfy the requirements under 37 CFR 2.21.

Applicants may choose goods and/or services identifications by selecting them directly from the Trademark Next Generation ID Manual (ID Manual) in the electronic application or enter them manually in a free-form text box. The USPTO proposes a $200 fee per class for descriptions of goods and services entered in the free-form text field.

Generally, examining attorneys do not need to review identifications of goods and/or services selected directly from the ID Manual within the electronic application form. Conversely, examining attorneys must carefully consider identifications entered in a free-form text box to determine whether the descriptions are acceptable as written or require amendment to sufficiently specify the nature of the goods and/or services. Examining attorneys must review each entry to determine its acceptability, even in situations where an applicant types or pastes the ID Manual identification, because they do not know if wording in the free-form text field came from the ID Manual.

Identifying an applicant's goods and/or services with sufficient specificity is necessary to provide adequate notice to third parties regarding the goods and/or services in connection with which the applicant intends to use, or is using, the mark. It also ensures the applicant pays the corresponding fee for each class of goods and/or services. Examining attorneys often spend substantial time reviewing identifications provided in the free-form text field and may initiate multiple communications with the applicant before determining an acceptable identification and collecting the appropriate fees. The proposed surcharge would help recover the additional costs associated with these more extensive reviews.

In addition to entering identifications in the free-form text field, some applicants submit extensive lists of goods and/or services. In more egregious cases, a list may comprise multiple pages and include goods and services in multiple classes. To ensure that applicants who submit lengthy identifications pay the costs of reviewing them, the USPTO proposes a fee of $200 for each additional group of 1,000 characters beyond the first 1,000 characters in the free-form text field, including punctuation and spaces. The fee would also apply to amended identifications that exceed the character limit in a response to an office action. Approximately 9% of trademark applications contain identifications of goods and/or services that exceed 1,000 characters per class. Applicants who enter identifications directly from the ID Manual within the electronic application would not incur this fee, even if the identification exceeds 1,000 characters.

The USPTO selected a character-based limit for operational efficiency, as the electronic application system can perform character counts in real time and alert the applicant when the limit has been exceeded. A limit based on other criteria, such as a count of separate goods and/or services, would require examiner review, as automating such counts is not technologically feasible. Such reviews by an examining attorney would increase the cost of examination, counteracting the purpose of the proposed fee, which is to ensure that applicants who submit lengthy identifications pay the costs of reviewing them.

The USPTO proposes a $50 fee increase for AAUs and SOUs (from $100 to $150 per class for electronic filings and $200 to $250 per class for paper filings). The agency has not adjusted AAU and SOU fees since 2002, even as processing costs increased during the subsequent two decades. This proposal improves cost recovery and helps rebalance the fee structure.

The percentage of trademark registrants choosing to maintain their registrations is declining. The USPTO expects this trend to continue due to anticipated growth in application submissions from groups historically less likely to maintain a registration. Given these changes in demand and filing behaviors, the agency proposes rebalancing aggregate revenue derived from renewals and other post-registration maintenance fees, including declarations of use and incontestability, to keep barriers to entry low for new applicants.

The USPTO proposes a $100 fee increase for filing a letter of protest (from $50 to $150). The proposed fee is less than half the agency's cost of processing a letter of protest, which allows a third party to bring evidence to the USPTO on the registrability of a mark in a pending application without filing an opposition with the Trademark Trial and Appeal Board (TTAB). The letter of protest procedure is not a substitute for the statutory opposition and cancellation procedures available to third parties who believe they would be damaged by registration of the involved mark. Instead, it is intended to assist examination without causing undue delay or compromising the integrity and objectivity of the ex parte examination process, which involves only the applicant and the USPTO.

The USPTO's costs for reviewing and processing each letter of protest are more than six times the current fee. This imbalance between the fee collected and the cost to perform the service are compounded by a substantial increase in letters of protest forwarded to the USPTO each year, which have risen from about 2,300 in FY 2016 to nearly 4,000 in FY 2023. The agency estimates this volume will grow to more than 5,000 letters annually by FY 2029, further increasing the USPTO's overall associated costs.

When viewed in the context of USPTO actions because of letters of protest, the agency's costs are considerable, while the letters have a minor impact on examination outcomes. During FY 2022, the USPTO decided 4,557 letters of protest, of which 1,433 (31%) were not in compliance with 37 CFR 2.149 and therefore not included in the record of examination. Of the letters entered into the record, examining attorneys issued a refusal based on the asserted ground(s) in 1,213 cases (27% of letters decided). Examining attorneys likely would have issued a refusal in these cases even without a letter of protest. The USPTO only identified 27 (0.59%) letters in FY 2022 that corresponded to an error in publishing a mark for opposition, similar to historical shares of letters decided each year.

In accordance with the USPTO's fee setting policy factors, this proposal recovers more of the costs associated with letters of protest, although the fee remains below the agency's full costs.

Throughout this document, “we,” “us,” and “our” refer to the EPA.

Table 1 lists the rule addressed by this proposal, including the date it was adopted by the District and the date it was submitted to the EPA by the California Air Resources Board (CARB or “the State”). The TCAPCD is the air pollution control agency for Tehama County in California.

On November 11, 2023, the submittal for Rule 2:3C was deemed by operation of law to meet the completeness criteria in 40 CFR part 51, appendix V, which must be met before formal EPA review.

There are no previous versions of Rule 2:3C in the California SIP.

Rule 2:3C is intended to address the CAA's statutory and regulatory requirements for Nonattainment New Source Review (NNSR) permit programs for major sources emitting nonattainment air pollutants and their precursors.

The EPA's May 2012 designation of the Tuscan Buttes area of the TCAPCD as a nonattainment area for the 2008 ozone National Ambient Air Quality Standards (NAAQS)  2 triggered the requirement for the District to develop and submit a NNSR program to the EPA for SIP approval. CAA section 172(b) and 40 CFR 51.1114. Because Tehama County is designated (in part) and classified as Marginal nonattainment for the 2008 ozone NAAQS, the District's NNSR program must satisfy the NNSR requirements applicable to Marginal ozone nonattainment areas. See 40 CFR 51.1102. As Tehama County (partial, Tuscan Buttes area) is also designated and classified as Marginal nonattainment (Rural Transport) for the 2015 ozone NAAQS, 3 TCAPCD's NNSR program is also required to satisfy the NNSR requirements applicable to Marginal ozone nonattainment areas for purposes of the 2015 ozone NAAQS. See 40 CFR 51.1302, 51.1314. 4

Additional information regarding the District's ozone nonattainment status and attainment/nonattainment designations for other criteria pollutants is included in our Technical Support Document (TSD), which may be found in the docket for this rule.

The EPA reviewed Rule 2:3C for compliance with CAA requirements for: (1) stationary source preconstruction permitting programs as set forth in CAA part D, including CAA sections 172(c)(5) and 173; (2) the review and modification of major sources in accordance with 40 CFR 51.160-51.165 as applicable in Marginal ozone nonattainment areas; (3) the review of new major stationary sources or major modifications in a designated nonattainment area that may have an impact on visibility in any mandatory Class I Federal Area in accordance with 40 CFR 51.307; (4) SIPs in general as set forth in CAA section 110(a)(2), including 110(a)(2)(A) and 110(a)(2)(E)(i);  5 and (5) SIP revisions as set forth in CAA section 110(l)  6 and 193. 7 Our review evaluated the submittal for compliance with the NNSR requirements applicable to Marginal ozone nonattainment areas, and ensured that the submittal addressed the NNSR requirements for the 2008 and 2015 ozone NAAQS.

With respect to procedural requirements, CAA sections 110(a)(2) and 110(l) require that revisions to a SIP be adopted by the state after reasonable notice and public hearing. Based on our review of the public process documentation included in the May 11, 2023, submittal of Rule 2:3C, we find that the TCAPCD has provided sufficient evidence of public notice, opportunity for comment and a public hearing prior to adoption and submittal of this rule to the EPA.

With respect to the substantive requirements found in CAA sections 172(c)(5) and 173, and 40 CFR 51.160-51.165, we have evaluated TCAPCD Rule 2:3C in accordance with the applicable CAA and regulatory requirements that apply to NNSR permit programs under part D of title I of the Act for all relevant ozone NAAQS. We find that Rule 2:3C satisfies these requirements as they apply to sources subject to the NNSR permit program requirements applicable to Marginal ozone nonattainment areas. We have also determined that this rule satisfies the related visibility requirements in 40 CFR 51.307. In addition, we have determined that Rule 2:3C satisfies the requirement in CAA section 110(a)(2)(A) that regulations submitted to the EPA for SIP approval be clear and legally enforceable, and have determined that the submittal demonstrates in accordance with CAA section 110(a)(2)(E)(i) that the District has adequate personnel, funding, and authority under state law to carry out this proposed SIP revision. Our TSD contains a more detailed discussion of our analysis of Rule 2:3C.

Regarding the additional substantive requirements of CAA sections 110(l) and 193, our action will result in a more stringent SIP, while not relaxing any existing provision contained in the SIP. We have concluded that our action would comply with section 110(l) because our approval of TCAPCD Rule 2:3C will not interfere with any applicable requirement concerning attainment and reasonable further progress, or any other CAA applicable requirement. In addition, our approval of Rule 2:3C will not relax any pre-November 15, 1990 requirement in the SIP, and therefore changes to the SIP resulting from this action ensure greater or equivalent emission reductions of ozone and its precursors in the District; accordingly, we have concluded that our action is consistent with the requirements of CAA section 193.

As authorized in section 110(k)(3) of the Act, the EPA proposes to approve the submitted rule because it fulfills all relevant requirements.

We have concluded that our approval of the submitted rule would comply with the relevant provisions of CAA sections 110(a)(2), 110(l), 172(c)(5), 173, and 193, and 40 CFR 51.160-51.165 and 40 CFR 51.307. If we finalize this action as proposed, our action will be codified through revisions to 40 CFR 52.220 (Identification of plan-in part).

In conjunction with the EPA's SIP approval of the District's visibility provisions for sources subject to the NNSR program as meeting the relevant requirements of 40 CFR 51.307, this action would also revise the regulatory provision at 40 CFR 52.281(d) concerning the applicability of the visibility Federal Implementation Plan (FIP) at 40 CFR 52.28 as it pertains to California, to provide that this FIP does not apply to sources subject to review under the District's SIP-approved NNSR program.

We will accept comments from the public on this proposal until April 25, 2024.

In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference Rule 2:3C, “New and Modified Major Sources in the Tuscan Buttes Nonattainment Areas,” adopted on February 28, 2023. Rule 2:3C is intended to address the CAA's statutory and regulatory requirements for Nonattainment New Source Review permit programs for major sources emitting nonattainment air pollutants and their precursors under part D of title I of the CAA. The EPA has made, and will continue to make, these materials available through https://www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

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

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

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

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

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

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

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

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

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

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

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

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

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

• Chemical manufacturing (NAICS code 325);

• Petroleum refineries (NAICS code 324110); and

• Tire manufacturing (NAICS code 32621).

This action may also affect manufacturers of substances for commercial purposes that coincidentally produce the substance during the manufacture, processing, use, or disposal of another substance or mixture, including byproducts and impurities. Such byproducts and impurities may, or may not, in themselves have commercial value. They are nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical product for a commercial purpose.

EPA is proposing to require manufacturers of chemical substances listed in this document to submit copies and lists of certain unpublished health and safety studies to EPA. This proposed rule is intended to provide EPA with useful information for prioritization, risk evaluations, and risk management under TSCA section 6 regarding the chemical substances discussed below. This action lists the chemical substances and their Chemical Abstracts Service Registry Numbers (CASRNs) that would be added to 40 CFR 716. It also lists proposed specific data reporting requirements.

EPA promulgated the Health and Safety Data Reporting Rule that is codified at 40 CFR part 716 under TSCA section 8(d) (15 U.S.C. 2607(d)). EPA is proposing this rule under its authority in TSCA section 8(d) to require the submission of health and safety studies, and lists of studies, regarding certain chemical substances.

EPA prepared an economic analysis of the impacts associated with the proposed addition of the 16 chemical substances to the TSCA section 8(d) Health and Safety Data Reporting rule, titled, “TSCA Section 8(d): Economic Impact Analysis for Adding 16 Chemicals to the Health and Safety Data Reporting Rule” (Ref. 1). This economic analysis is available in the docket and is summarized here.

EPA estimates that the costs of this action will be approximately $301,956 in the first year of reporting, with 3,388 estimated paperwork burden hours. In addition, EPA has determined that, of the 44 small businesses affected by this action, 1 is estimated to incur a maximum annualized cost impact of more than 1% of revenues. Thus, this action is not expected to have a significant adverse economic impact on a substantial number of small entities as further discussed in Unit IV.C.

1. Submitting CBI. Do not submit CBI to EPA through https://www.regulations.gov or email. If you wish to include CBI in your comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the part or all of the information that you claim to be CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2 and/or 40 CFR part 703, as applicable.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.html.

EPA is proposing the addition of 16 chemical substances to amend the list at 40 CFR 716.120. This list contains chemical substances for which the health and safety study data reporting is required. For this proposed rule, the 16 chemical substances will amend the current list and be added at 40 CFR 716.21(a)(11). If any special exemptions are required for a specific chemical substance, it will be identified in the table below under special exemptions. Special exemptions are reporting requirements that are specific to a chemical substance and would include specific language about specific studies and requirements. The chemical substances being added by this proposed rule are listed below:

• 4,4-Methylene bis(2-chloraniline) (CASRN 101-14-4);

• 4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol) (CASRN140-66-9);

• Acetaldehyde (CASRN75-07-0);

• Acrylonitrile (CASRN 107-13-1);

• Benzenamine (CASRN 62-53-3);

• Benzene (CASRN 71-43-2);

• Bisphenol A (CASRN 80-05-7);

• Ethylbenzene (CASRN 100-41-4);

• Naphthalene (CASRN 91-20-3);

• Vinyl Chloride (CASRN 75-01-4);

• Styrene (CASRN 100-42-5);

• Tribomomethane (Bromoform) (CASRN 75-25-2);

• Triglycidyl isocyanurate; (CASRN 2451-62-9);

• Hydrogen fluoride (CARN 7664-39-3);

• N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) (CASRN 793-24-8); and

• 2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone) (CASRN 2754428-18-5).

The proposed reporting requirements for the 16 chemical substances listed in Unit II.A. include the following, with the specific types of health and safety studies listed in Unit II.D.:

• Manufacturers who, in the 10 years preceding the date a chemical substance is listed, either have proposed to manufacture or have manufactured any of the listed chemical substances must submit to EPA, during the 60-day reporting period specified in 40 CFR 716.65 and according to the reporting schedule set forth at 40 CFR 716.60, would be required to submit a copy of each specified type of health and safety study which is in their possession at the time the chemical substance is listed in 40 CFR part 716.

• Manufacturers who, either at the time of or after the chemical substance is listed in part 716, propose to manufacture or are manufacturing the listed chemical substance would be required to submit to EPA during the 60-day reporting period specified in 40 CFR 716.65 and according to the reporting schedule set forth at 40 CFR 716.60:

The proposed reporting would be required 90 days after date the final rule is issued from those who manufacture or proposes to manufacture the listed chemical substance from [ to be determined 30 days after date of publication of the final rule ] to [ to be determined as 90 days after date of publication of the final rule ] must inform EPA (by submitting a list) of any studies initiated during the period from [ to be determined as 30 days after date of publication of the final rule ] to [ to be determined as 90 days after date of publication of the final rule ] within 30 days of their initiation, but in no case later than [ to be determined as 120 days after date of publication of the final rule ].

The proposed reporting described in Unit II.D. would be required 90 days after the final rule is issued from those who manufactures or proposes to manufacture the listed chemical substance from [ to be determined as 30 days after date of publication of the final rule ] to [ to be determined as 90 days after date of publication of the final rule ] must inform EPA (by submitting a list) of any studies initiated during the period from [ to be determined as 30 days after date of publication of the final rule ] to [ to be determined as 90 days after date of publication of the final rule ] within 30 days of their initiation, but in no case later than [ to be determined as 120 days after date of publication of the final rule ].

In addition, if any such person has submitted lists of studies that were ongoing or initiated during the period from [ to be determined as 30 days after date of publication of the final rule ] to [ to be determined as 90 days after date of publication of the final rule ] to EPA, such person must submit a copy of each study within 30 days after its completion, regardless of the study's completion date. See 40 CFR 716.60 and 716.65.

Detailed guidance for reporting unpublished health and safety data is provided at 40 CFR part 716. Also found at 40 CFR 716.20 are explanations of reporting exemptions. EPA is proposing that the exemption listed at 40 CFR 716.20(a)(9), for persons manufacturing a substance only as an impurity, would not be available for the substances subject to this proposed rule. An impurity is defined as a chemical substance that is unintentionally present with another chemical substance. Impurities are not manufactured for distribution in commerce as chemical substances and have no commercial purpose separate from the chemical substance or mixture of which they are a part. Rulemaking proceedings that add chemical substances and mixtures to 40 CFR 716.120 will specify the types of health and safety studies that must be reported and will specify chemical grade/purity that must be met or exceeded in individual studies. Pursuant to the rulemaking procedure that requires EPA to identify the chemical/grade purity, EPA is requiring reporting on any purity level of the chemical.

EPA is proposing to require submissions of health and safety studies from companies manufacturing the identified chemical substances, including when a company is importing the chemical substance as a pure substance, mixture, formulated product, or article contains the subject chemical substance. Reporting would be required where the chemical substance is included as an impurity. EPA considers conditions of use associated with circumstances where a chemical substance subject to a risk evaluation even where the chemical substance is an impurity. To such ends, health and safety information associated with the conditions of use, whether as a pure chemical, part of a mixture or article, or as an impurity helps inform such risk evaluation. Accordingly, the chemicals included in today's action are of particular interest to EPA because they are either in the process of prioritization as candidates for high-priority designation or are expected to be candidates in the upcoming years. For those found to be of high priority, EPA is required to immediately conduct a risk evaluation. Collecting health and safety studies on the chemicals identified by this proposal will assist EPA in selecting chemicals to designate as high-priority chemicals as well as conduct risk evaluation on such designated chemicals.

Pursuant to 40 CFR 716.10 and 716.50, manufacturers are required to submit the following types of information:

• Lists and copies of unpublished health and safety studies for all substances specified in this rule on health effects, such as toxicity studies ( e.g., in vivo, in vitro) on carcinogenicity, reproductive and developmental effects, genotoxicity, neurotoxicity, immunotoxicity, endocrine effects, and other systemic toxicity and toxicokinetic (absorption, distribution, metabolism, or elimination), including modeling studies, in humans or animals.

• All unpublished studies on environmental effects and physical-chemical properties if performed as described in 40 CFR 716.50.

• All unpublished studies on occupational, general population, consumer, and environmental exposure, such as: unpublished studies on inhalation and dermal exposure, human biomonitoring, environmental monitoring of indoor and outdoor air, soil, water, and household dust, chamber emission rates from products or polymeric matrices, and unpublished modeling studies that estimate environmental concentrations or human exposures.

• Studies showing any measurable content of the tested substance (single substance or mixture). The composition and purity of test substances must be reported if included as part of the study.

• Studies previously submitted to EPA pursuant to a requirement under TSCA or of the submitter's own accord and studies conducted or to be conducted pursuant to a TSCA section 4 action are exempt from the submission of lists of health and safety studies required under 40 CFR 716.35 and the submission of studies required under this rule.

• Surveys, tests, and studies of biological, photochemical, and chemical degradation. Chemical identities are part of the submitted health and safety studies or data and must be submitted to EPA. Information from health and safety studies and/or data is not protected from disclosure, except to the extent such studies or information reveal information “that discloses processes used in the manufacturing or processing of a chemical substance. Or, in the case of a mixture, the portion of the mixture comprised by any of the chemical substances in the mixture,” 15 U.S.C. 2613(2)(B). Additional information, listed in the rule's definition of health and safety study, are not part of a health and safety study ( e.g., names of laboratory personnel). Submitters asserting a CBI claim for information are required to submit a sanitized copy, removing only the information that is claimed as CBI.

All submitters would be required to report TSCA section 8(d) data electronically, using the CSPP: Submissions for Chemical Safety and Pesticide Programs software (CSPP Software) accessible via EPA's Central Data Exchange (CDX) system available at https://cdx.epa.gov/. The CSPP Software provides a TSCA 8(d) Health and Safety Data Reporting application that a registered CDX user will access to submit TSCA section 8(d) records. Information on how to submit TSCA section 8(d) data is available in the docket (EPA-HQ-OPPT-2023-0360) and via EPA's TSCA section 8(d) web page for this action at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/section-8d-health-safety-data-reporting-user-guide-0. Submitters may also contact EPA's TSCA Hotline at tsca-hotline@epa.gov or 202-554-1404. For help with accessing your CDX account, please contact the CDX help desk at https://cdx.epa.gov/contact or (888) 890-1995 (for international callers: (970) 494-5500).

1. Submitting confidential business information. Any person submitting copies of records may assert a business confidentiality claim covering all or part of the submitted information in accordance with the procedures described in 40 CFR part 703 (88 FR 37155, June 7, 2023 (FRL-8223-02-OCSPP)). Requirements for asserting and maintaining confidentiality claims are described in 40 CFR 703.5. Such claim must be made concurrent with submission of the information. If no such claim accompanies the submission, EPA will not recognize a confidentiality claim, and the information in that submission may be made available to the public without further notice. Confidentiality claims must be substantiated at the time of submission to EPA pursuant to the requirements of 40 CFR 703.5(b). To assert a claim of confidentiality for information contained in a submitted record, the respondent must submit two copies of the document. One copy must be complete. In that copy, the respondent must indicate what information, if any, is claimed as confidential by marking the specific information on each page with a label such as “confidential”, “proprietary”, or “CBI.” The other copy must be a public version of the submission and attachments, with all information that is claimed as confidential removed (40 CFR 703.5(c)). Both the copy containing information claimed as CBI and the “sanitized” copy must be submitted electronically. The TSCA section 8(d) Health and Safety Data Reporting application incorporates many of the requirements for asserting CBI claims, including substantiation questions, a required certification statement, and prompts to provide a sanitized copy. Further details regarding the requirements for confidentiality claims can be found in 40 CFR part 703.

2. Submitting harmonized templates. Additionally, EPA finalized the requirement for submitting all existing information concerning health and environmental effects in the format of Organization of Economic Cooperation and Development's (OECD) harmonized templates, where such templates exist for the type of data (codified at 40 CFR 705.15(f)). OECD templates are accessible to the public online at https://oecd.org/ehs/templates/harmonised-templates.htm. This can be accomplished by using the freely available IUCLID6 software by exporting the dossier in the OECD Harmonized Template working context. EPA can accept any dossiers generated using any version of IUCLID6 available at https://www.epa.gov/tsca-cbi/final-rule-requirements-confidential-business-information-claims-under-tsca#Implementation. EPA believes that some of the data will already be available as an OECD template if the company had already submitted the studies under the European Union's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. In addition to the required template format, those subject to this rulemaking must submit any associated full study reports or underlying data as support documents. The full study reports and support documents are necessary for EPA to understand the full context and evaluate the quality of the data, which is necessary for the Agency to review to determine whether such data may be used for any future Agency actions. If an OECD-harmonized template is not available for a particular endpoint for which the manufacturer has relevant information, then the manufacturer must still submit the data. Such information may include, but is not limited to, raw monitoring data (regardless of having been aggregated or analyzed) of human or environmental exposure assessments and toxicity tests for either human health effects or ecological other environmental effects.

EPA assessment of chemical substances under TSCA section 6 involves a three-stage process: (1) prioritization, (2) risk evaluation, and, as applicable, (3) risk management. Prioritization and risk evaluation are carried out in accordance with procedural regulations at 40 CFR part 702, subparts A and B, respectively.

During prioritization, EPA identifies chemical substances that are candidates for prioritization and then uses reasonably available information to screen each candidate chemical substance against certain criteria and considerations specified in TSCA section 6(b)(1)(A):

• The hazard and exposure potential of the chemical substance;

• Persistence and bioaccumulation of the chemical substance;

• Potentially exposed or susceptible subpopulations;

• Storage near significant sources of drinking water;

• The conditions of use or significant changes in the conditions of use of the chemical substance (Conditions of use is defined under TSCA section 3(4) to mean “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used or disposed of.”);

• The volume or significant changes in the volume of the chemical substance manufactured or processed; and

• Other risk-based criteria that EPA determines to be relevant to the designation of the chemical substance's priority.

EPA identified 15 chemical substances that are the subject of this proposal as potential candidates for prioritization based on a screening process that is based on a combination of hazard, exposure (including uses), and persistence and bioaccumulation characteristics. To support the prioritization process as well as to inform its risk evaluation findings on any of these substances that EPA might designate as a high-priority substance, EPA is seeking unpublished health and safety studies on these chemical substances to ensure that such studies are available to EPA to inform any activities undertaken pursuant to TSCA section 6. EPA is also including the 6PPD transformation product, 2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone) (CASRN: 2754428-18-5) due to a response to a recent citizen's petition filed under TSCA section 21 received on 6PPD and 6PPD-quinone. Cited in the petition are the potential impacts of 6PPD-quinone to aquatic organisms and on population levels for some fish, such as the coho salmon. The Agency is including this chemical in this proposed request for unpublished health and safety studies to address data needs and to better understand and characterize risks associated with this chemical. For details on 6PPD and 6PPD-quinone and EPA's current key actions to address this chemical, please visit, https://www.epa.gov/chemical-research/6ppd-quinone.

Information received pursuant to the final rule will help inform other EPA activities involving such chemical substances. Additionally, non-CBI information collected pursuant to the final rule would be made public via ChemView.

Estimated benefits of the final rule include addressing market failure stemming from incomplete or imperfect information regarding the hazards associated with the listed chemicals. This final rule addresses market failure by making information about the health and safety effects of the listed chemicals available to EPA. By making this information available, EPA will be able to base decisions on actual data rather than relying on assumptions. Additionally, the information provided by this rule can aid in addressing negative externalities that occur when the costs associated with known hazards are external to manufacturers' decision-making and may result in overuse and/or overproduction of certain harmful products.

The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA. For more information about these references, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

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

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

This action does not impose any new information collection burden under the PRA, 44 U.S.C. 3501 et seq. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2070-0224 (EPA ICR No. 2703.01). This action requires the reporting of health and safety data to EPA by manufacturers of certain chemical substances to be added to the Health and Safety Data Reporting Rule. EPA intends to use information collected under the rule to assist in chemical assessments under TSCA, and to inform any additional work necessary under environmental protection mandates beyond TSCA. Submitters may designate information as confidential, trade secret, or proprietary. EPA has implemented procedures to protect any confidential, trade secret or proprietary information from disclosure. These procedures comply with TSCA section 14 and EPA's confidentiality regulation, 40 CFR part 2, subpart B. This action requires the reporting of health and safety data to EPA by manufacturers of certain chemical substances to be added to the Health and Safety Data Reporting Rule. EPA intends to use information collected under the rule to assist in chemical assessments under TSCA, and to inform any additional work necessary under environmental protection mandates beyond TSCA. Submitters may designate information as confidential, trade secret, or proprietary.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.

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

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. The small entities subject to the requirements of this action are manufacturers of 16 chemicals to be added to the Health and Safety Data Reporting Rule. The Agency has determined that 44 out of 161 of the firms in the affected universe are small entities. Of those small firms, 13 may experience an impact of above 1% and 3 may have impacts above 3%. Details of this analysis are presented in the Economic Analysis of this rule (Ref. 1), which can be found in the docket.

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

This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000) because it will not have substantial direct effects on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. It does not have substantial direct effects on tribal government because this action relates to toxic chemical reporting under EPCRA section 313, which primarily affects private sector facilities. Thus, Executive Order 13175 does not apply to this action.

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to regulatory actions considered significant under section 3(f)(1) of Executive Order 12866 and that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of Executive Order 13045.

Since this is not a “covered regulatory action,” E.O. 13045 does not apply. However, the Policy on Children's Health does apply. Although this action does not concern an environmental health or safety risk, the information obtained from the reporting required by this rule will be used to inform the Agency's decision-making process regarding chemical substances to which children may be exposed. This information will also assist the Agency and others in determining whether the chemical substances included in this proposed rule present potential risks, allowing the Agency and others to take appropriate action to investigate and mitigate those risks.

This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution or use of energy and has not otherwise been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action.

This rulemaking does not involve any technical standards. As such, NTTAA section 12(d), 15 U.S.C. 272, does not apply to this action.

EPA believes that this type of action does not directly impact human health or environmental conditions. Although this action does not directly impact human health or environmental conditions, EPA identifies and addresses environmental justice concerns in accordance with Executive Orders 12898 (59 FR 7629, February 16, 1994) and 14096 (88 FR 25251, April 26, 2023) by requiring reporting of unpublished health and safety data. This regulatory action requires the submission of unpublished health and safety data for 16 chemical substances that will result in more information being collected and provided to the public. All consumers of products made from these chemicals could benefit from data regarding the chemicals' health and environmental effects. By requiring reporting of these unpublished studies, EPA provides communities across the U.S. (including communities with environmental justice concerns) with access to these studies. This information can also be used by government agencies and others in determining the potential hazards and risks associated with the listed chemicals. Therefore, the informational benefits of the action will have a positive impact on the human health and environmental impacts on communities with environmental justice concerns.

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

I. Background

DoD is proposing to revise the DFARS to remove the solicitation provision at DFARS 252.247-7022, Representation of Extent of Transportation By Sea, and to revise the contract clause at DFARS 252.247-7023, Transportation of Supplies by Sea, accordingly, to effect the purpose of the provision using only the clause. This change will streamline instructions to contractors regarding required notifications to the Government of transportation of supplies by sea.

Currently, DFARS provision 252.247-7022 and DFARS clause 252.247-7023 are included in all solicitations with an anticipated value greater than the simplified acquisition threshold, except solicitations for direct purchase of ocean transportation services. The provision requires the offeror to represent whether supplies will or will not be transported by sea in performance of the contract or any subcontract. The clause notifies offerors of their responsibilities when transporting supplies by sea, which include the use of U.S. flag vessels, unless certain situations apply; the submission of a certification with a final invoice; and submission of bills of lading to the contracting officer and to the U.S. Department of Transportation Maritime Administration (MARAD).

The provision's notification requirement was intended to aid acquisition personnel in carrying out their responsibilities under the clause. By effecting the notification via a solicitation provision, a representation is required from all offerors rather than just the awardee. Given the offeror's representation has no bearing on its eligibility or selection for award, the notification is better suited to be a requirement in the clause, where only the awardee must notify the contracting officer, as well as MARAD, only if transportation of supplies by sea will occur. Including MARAD on the notification provides all impacted parties with situational awareness and an ability to be proactive in ensuring compliance with the clause requirements.

Given that DFARS clause 252.247-7023 is included in nearly all contracts, and DFARS provision 252.247-7022 is associated with the requirements of 252.247-7023, the text of the clause and provision can be combined. The result reduces the number of provisions required to be used in solicitations and the number of representations offerors must provide, while still maintaining the effect of DFARS provision 252.247-7022.

Consequent to removing DFARS clause 252.247-7022, this rule removes the clause prescription at DFARS 247.574(a) as well as direction at DFARS 204.1202 and 212.301 relating to the provision.

This rule removes the provision at DFARS 252.247-7022, along with its prescription at DFARS 247.574(a), and amends the clause at DFARS 252.247-7032 accordingly to include the substance of the provision. However, this proposed rule does not impose any new requirements on contracts at or below the SAT, for commercial products including COTS items, or for commercial services. The clause will continue to apply to acquisitions at or below the SAT, to acquisitions of commercial products including COTS items, and to acquisitions of commercial services.

This change is expected to streamline instructions to contractors regarding notifications of transportation of supplies by sea. Presently, DFARS provision 252.247-7022 is included in nearly all solicitations and DFARS clause 252.247-7023 is included in nearly all contracts. By effectively combining the provision and the clause, this proposed rule will reduce the number of provisions required to be used in solicitations and the number of representations offerors must provide, while still maintaining the effect of DFARS provision 252.247-7022. Therefore, this proposed rule is expected to reduce administrative burden on contractors, including small businesses.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, as amended.

DoD does not expect this proposed rule, when finalized, to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because the rule does not create any new requirements or add to any existing requirements for contractors. However, an initial regulatory flexibility analysis has been performed and is summarized as follows:

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to remove a solicitation provision and accordingly to modify the text of an existing DFARS contract clause to include the operative text of that DFARS provision.

The objective of this proposed rule is to streamline the instructions to contractors pertaining to the transportation of supplies by sea. The legal basis for the proposed rule is 41 U.S.C. 1303.

This proposed rule will likely affect small entities that will be awarded contract actions that include DFARS clause 252.247-7023, Transportation of Supplies by Sea. Data was obtained from the Procurement Business Intelligence Service for all contracts and modifications that include DFARS clause 252.247-7023 for fiscal years 2020 through 2022. DoD awarded on average 642,310 contract actions per year that included DFARS clause 252.247-7023 to 30,680 unique entities, of which approximately 359,315 contract awards (56 percent) were made to 21,070 unique small entities (69 percent).

The proposed rule does not impose any new reporting, recordkeeping, or compliance requirements.

The proposed rule does not duplicate, overlap, or conflict with any other Federal rules.

There are no known significant alternatives that would accomplish the objectives of the proposed rule.

DoD invites comments from small business concerns and other interested parties on the expected impact of this proposed rule on small entities.

DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2020-D026), in correspondence.

The Paperwork Reduction Act (44 U.S.C. chapter 35) applies to this proposed rule. However, these changes to the DFARS do not impose additional information collection requirements to the paperwork burden previously approved by the Office of Management and Budget (OMB) under OMB Control Number 0704-0245, entitled Defense Federal Acquisition Regulation Supplement (DFARS) Part 247, Transportation and Related Clauses.

Therefore, 48 CFR parts 204, 212, 247, and 252 are proposed to be amended as follows:

The revisions and additions read as follows:

The revision reads as follows:

The revision reads as follows:

Previous Federal Actions

Please refer to our September 7, 2021, proposed rule (86 FR 49989) for a detailed description of previous Federal actions concerning the pyramid pigtoe. We accepted submission of new information and comments on our September 7, 2021, proposed rule for 60 days, ending November 8, 2021.

Consistent with section 4(b)(6)(A)(i)(IV) of the Act, we are notifying the public that we are withdrawing the September 7, 2021, proposed rule to list the pyramid pigtoe as a threatened species with an associated rule issued under section 4(d) of the Act (“4(d) rule”) (86 FR 49989). The basis for this action is described below.

It is our intent in this withdrawal to discuss the new information identifying the pyramid pigtoe and round pigtoe as conspecific (belonging to the same species) that serves as the basis for our decision. A thorough review of the life history, ecology, and overall viability of what was considered pyramid pigtoe at the time the September 7, 2021, proposed rule was published is found in the species status assessment report (SSA report) (version 1.0; Service 2021, pp. 19-36).

Species identification of pyramid pigtoe and round pigtoe, as well as between other related taxa, is challenging due to morphological similarity and phenotypic plasticity. It is further exacerbated by the fact that many species are sympatric (overlapping in geographical distribution) (Olivera-Hyde et al. 2023, pp. 2-5). Recent genetic studies led researchers to suggest that the pyramid pigtoe and the round pigtoe may be conspecific (Inoue et al. 2018, p. 694; Olivera-Hyde et al. 2023, pp. 8-14), although species experts continued to support recognition of the pyramid pigtoe as a valid taxon due to morphological differences and a lack of comprehensive rangewide genetic information comparing the similar taxa (Olivera-Hyde et al. 2023, p. 15; Williams et al. 2017, p. 39). Because the pyramid pigtoe and round pigtoe are difficult to differentiate, there has been frequent misidentification by experts and lumping of the taxa together in the academic literature (Olivera-Hyde et al. 2023, pp. 2-5).

Both the SSA report for the pyramid pigtoe and the September 7, 2021, proposed rule to list the pyramid pigtoe as a threatened species (86 FR 49989) acknowledge the difficulty in identifying the pyramid pigtoe. After reviewing the best scientific information available at that time, we agreed with mussel experts and found that the pyramid pigtoe was a valid taxon (Service 2021, pp. 12-13; see also 86 FR 49989, September 7, 2021). Since that finding, however, a comprehensive, rangewide genetic analysis has been completed comparing pyramid pigtoe to round pigtoe, and this information now confirms that they are conspecific (Johnson et al., 2024, pp. 16-17).

Prior genetic analyses relied on results taken from individuals from portions of species' ranges, resulting in conclusions that were limited to only those areas where individuals were collected (Inoue et al. 2018, p. 698; Olivera-Hyde et al. 2023, p. 3). The new study uses data collected from throughout the ranges of both pyramid pigtoe and round pigtoe populations (Johnson et al., 2024, entire). Genetic data were successfully sampled from 200 individuals for mitochondrial DNA (mtDNA) analysis, 106 individuals for nuclear DNA (nDNA) analysis, and 176 individuals for genotype-by-sequencing (GBS) analysis across 11 populations and 22 waterbodies (Johnson et al., 2024, p. 33). Mitochondrial DNA and nDNA were used in previous studies but were found to be problematic for supporting species delineations in Pleurobema, due to potential hybridization and backcrossing effects, resulting in a reliance on hard-to-distinguish morphological variation for species delineations (Olivera-Hyde et al. 2023, p. 14). The most recent analysis incorporated GBS methodologies to address uncertainty in assessing whether pyramid pigtoe is a valid taxon (Johnson et al., 2024, p. 6.).

The results of the study support the hypothesis that pyramid pigtoe and round pigtoe are conspecific based on mtDNA, nDNA, and GBS data (Johnson et al., 2024, pp. 13-17). The results of the GBS analysis cluster individuals based on geographic location and not by species identification based on morphology (Johnson et al., 2024, p. 16). This finding is also supported by the results of the mtDNA and nDNA analyses and is consistent with the results of prior published findings (Inoue et al. 2018, p. 694; Olivera-Hyde et al. 2023, pp. 8-14). The results do not support the current morphologically-based species delineations.

New rangewide genetic information has become available since the publication of our September 7, 2021, proposed rule (86 FR 49989) to list the pyramid pigtoe as a threatened species with an associated section 4(d) rule under the Act. The new information is based on mtDNA, nDNA, and GBS data, and concludes that pyramid pigtoe and round pigtoe are conspecific. These results support the findings of previous studies that were too narrow in scope to make definitive conclusions of species delineation. The resulting single species (round pigtoe; P. sintoxia ) is wide-ranging and common throughout its current range. Because pyramid pigtoe ( P. rubrum ) is no longer considered a valid species, we withdraw the September 7, 2021, proposed rule (86 FR 49989) to list pyramid pigtoe as a threatened species with an associated section 4(d) rule.

A complete list of references cited in this document is available on the internet at https://www.regulations.gov and upon request from the Asheville Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT ).

The primary authors of this document are the staff members of the Fish and Wildlife Service's Species Assessment Team and the Asheville Ecological Services Field Office.

The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq. ).

We intend that any final action resulting from this proposed rule will be based on the best scientific and commercial data available and be as accurate and as effective as possible. Therefore, we request comments or information from other governmental agencies, Native American Tribes, the scientific community, industry, or any other interested parties concerning this proposed rule. We particularly seek comments concerning:

(1) The species' biology, range, and population trends, including:

(a) Biological or ecological requirements of the species, including habitat requirements for feeding, breeding, and sheltering;

(b) Genetics and taxonomy;

(c) Historical and current range, including distribution patterns and the locations of any additional populations of this species;

(d) Historical and current population levels, and current and projected trends; and

(e) Past and ongoing conservation measures for the species, its habitat, or both.

(2) Threats and conservation actions affecting the species, including:

(a) Factors that may be affecting the continued existence of the species, which may include habitat destruction, modification, or curtailment; overutilization; disease; predation; the inadequacy of existing regulatory mechanisms, or other natural or manmade factors;

(b) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to this species; and

(c) Existing regulations or conservation actions that may be addressing threats to this species.

(3) Additional information concerning the historical and current status of this species.

(4) Information on regulations that may be necessary and advisable to provide for the conservation of the pygmy sloth and that we can consider in developing a 4(d) rule for the species. In particular, we seek information concerning the extent to which we should include any of the section 9 prohibitions in the 4(d) rule or whether we should consider any additional exceptions from the prohibitions in the 4(d) rule.

Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include.

Please note that submissions merely stating support for, or opposition to, the action under consideration without providing supporting information, although noted, do not provide substantial information necessary to support a determination. Section 4(b)(1)(A) of the Act (16 U.S.C. 1533(b)(1)(A)) directs that determinations as to whether any species is an endangered or a threatened species must be made solely on the basis of the best scientific and commercial data available.

You may submit your comments and materials concerning this proposed rule by one of the methods listed in ADDRESSES . We request that you send comments only by the methods described in ADDRESSES .

If you submit information via https://www.regulations.gov, your entire submission—including any personal identifying information—will be posted on the website. If your submission is made via a hardcopy that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. We will post all hardcopy submissions on https://www.regulations.gov.

Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on https://www.regulations.gov.

Our final determination may differ from this proposal because we will consider all comments we receive during the comment period as well as any information that may become available after this proposal. Based on the new information we receive (and, if relevant, any comments on that new information), we may conclude that the species is endangered instead of threatened, or we may conclude that the species does not warrant listing as either an endangered species or a threatened species. In addition, we may change the parameters of the prohibitions or the exceptions to those prohibitions in the 4(d) rule if we conclude it is appropriate considering comments and new information received. For example, we may expand the prohibitions to include prohibiting additional activities if we conclude that those additional activities are not compatible with conservation of the species. Conversely, we may establish additional exceptions to the prohibitions in the final rule if we conclude that the activities would facilitate or are compatible with the conservation and recovery of the species. In our final rule, we will clearly explain our rationale and the basis for our final decision, including why we made changes, if any, that differ from this proposal.

Section 4(b)(5) of the Act provides for a public hearing on this proposal, if requested. Requests must be received by the date specified in DATES . Such requests must be sent to the address shown in FOR FURTHER INFORMATION CONTACT . We will schedule a public hearing on this proposal, if requested, and announce the date, time, and place of the hearing, as well as how to obtain reasonable accommodations, in the Federal Register at least 15 days before the hearing. We may hold the public hearing in person or virtually via webinar. We will announce any public hearing on our website, in addition to the Federal Register . The use of virtual public hearings is consistent with our regulations at 50 CFR 424.16(c)(3).

On November 15, 2013, we received a petition from the Animal Welfare Institute to add the pygmy sloth to the List of Endangered and Threatened Wildlife. On June 9, 2014, we published in the Federal Register (79 FR 32900) a 90-day finding that the petition presented substantial scientific and commercial information indicating that the petitioned action may be warranted; that document initiated a status review for the pygmy sloth.

A species status assessment (SSA) team prepared an SSA report for the pygmy sloth. The SSA team was composed of Service biologists, in consultation with other species experts. The SSA report represents a compilation of the best scientific and commercial data available concerning the status of the species, including the impacts of past, present, and future factors (both negative and beneficial) affecting the species.

In accordance with our joint policy on peer review published in the Federal Register on July 1, 1994 (59 FR 34270), and our August 22, 2016, memorandum updating and clarifying the role of peer review in listing actions under the Act, we solicited independent scientific review of the information contained in the pygmy sloth SSA report. We sent the SSA report to five independent peer reviewers and received three responses. Results of this structured peer review process can be found at https://www.regulations.gov at Docket No. FWS-HQ-ES-2023-0151. In preparing this proposed rule, we incorporated the results of these reviews, as appropriate, into the SSA report, which is the foundation for this proposed rule.

As discussed above in Peer Review, we received comments from three peer reviewers on the draft SSA report. We reviewed all comments we received from the peer reviewers for substantive issues and new information regarding the information contained in the SSA report. The peer reviewers generally concurred with our methods and conclusions, and provided additional information, clarifications, and suggestions, including clarifications on terminology, additional literature on phylogeny and diet, information on generation time, clarifications on published correspondence, updates regarding the ongoing conservation efforts for the pygmy sloth, clarification on the pygmy sloth's inclusion in Appendix II of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) (27 U.S.T. 1087), and other editorial suggestions. No substantive changes to our analysis and conclusions within the SSA report were deemed necessary, and peer reviewer comments are addressed in version 1.1 of the SSA report (Service 2023, entire).

The pygmy sloth, the smallest of the of four extant species of three-toed sloths, is a tan-colored arboreal mammal species with a near-white face and black stripes over the eyes. Adults weigh approximately 3 kilograms (kg) (6.6 pounds (lb)) and measure about 500 millimeters (mm) (1.6 feet (ft)) in length. The species is most closely related to the brown-throated three-toed sloth ( B. variegatus; hereafter “brown-throated sloth”; Ruiz-Garcia et al. 2020, pp. 468-470; Anderson and Handley 2001, pp. 9-15). The pygmy sloth was originally separated taxonomically from the more widespread brown-throated sloth (native to central America including mainland Panama and northern South America) based on its consistently smaller size and distinct skeletal structures (Anderson and Handley 2001, pp. 9-18). Having only been described as a full species in 2001, there is little detail available on the species' life history and habitat requirements.

Pygmy sloths are found only on the small Panamanian island Isla Escudo de Veraguas (hereafter, “Escudo”), which is 4.3 square kilometers (km 2 ) (1.7 square miles (mi 2 )) in area and lies about 18 kilometers (km) (11.2 miles (mi)) from the Panamanian mainland (Anderson and Handley 2001, p. 5). About 2.5 percent of the island is composed of red mangrove ( Rhizophora mangle ) thickets scattered along the north coast, and the remainder of the island is a mixed species tropical forest (Kaviar et al. 2012, pp. 1-3; Voirin 2015, p. 705; Zoological Society of London (ZSL) 2017, p. 11). It is uncertain whether sloths on Escudo are reliant on the mangroves or whether some live entirely within the interior forest (Voirin 2015, p. 705). All three-toed sloths are arboreal folivores; they consume leaves with relatively low nutritional quality, necessitating physiological and behavioral adaptations including limited movements and low muscle mass (Anderson and Handley 2001, p. 2). Pygmy sloths have been observed using at least 15 plant species (including mangroves) for food and refuge, but it is not known which, if any, plant species they require (Smith et al. 2021, unpaginated; Smith 2022, pers. comm.; Superina 2022, pers. comm.).

Few data exist specific to pygmy sloth reproduction and population biology. Based on demographic data for three-toed sloths, it is reasonable to conclude that an average generation time (or time between birth of an individual and birth of its offspring) is approximately 6 to 10 years for pygmy sloths (Anderson and Handley 2002, p. 1051; Taube et al. 2001, p. 184; Superina 2022, pers. comm.). Other three-toed sloth species have only one offspring per pregnancy after gestation of 100-180 days (Benirschke 2008, p. 168; Taube 2001, p. 184). Longevity and survivorship are little-known for three-toed sloths. Both genetic data, although limited, and documentation of sloth movement into the interior forest suggest that there is only a single population of the species (ZSL 2017, p. 9; Voirin 2015, p. 705; Silva 2013, p. 138).

A thorough review of the taxonomy, life history, and ecology of the pygmy sloth is presented in the SSA report (version 1.1; Service 2023, pp. 1-8).

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 endangered and threatened species. In 2019, jointly with the National Marine Fisheries Service, the Service issued a final rule that revised the regulations in 50 CFR part 424 regarding how we add, remove, and reclassify endangered and threatened species and the criteria for designating listed species' critical habitat (84 FR 45020; August 27, 2019). On the same day, we issued a final rule that revised 50 CFR 17.31 and 17.71 (84 FR 44753; hereinafter, “the 2019 4(d) rule”) and ended the “blanket rule” option for application of section 9 prohibitions to species newly listed as threatened after the effective date of those regulatory revisions (September 26, 2019). Blanket rules had extended the majority of the protections (all of the prohibitions that apply to endangered species under section 9 and additional exceptions to the prohibitions) to threatened species, unless we issued an alternative rule under section 4(d) of the Act for a particular species ( i.e., a species-specific 4(d) rule). The blanket rule protections continued to apply to threatened species that were listed prior to September 26, 2019, without an associated species-specific rule. Under the 2019 4(d) rule, the only way to apply protections to a species newly listed as threatened is for us to issue a species-specific rule setting out the protective regulations that are appropriate for that species.

Our analysis for this decision applied the regulations that are currently in effect, which include the 2019 revisions. However, we proposed further revisions to these regulations on June 22, 2023 (88 FR 40742; 88 FR 40764). In case those revisions are finalized before we make a final status determination for this species, we have also undertaken an analysis of whether the decision would be different if we were to apply those proposed revisions. We concluded that the decision would have been the same if we had applied the proposed 2023 regulations. The analyses under both the regulations currently in effect and the regulations after incorporating the June 22, 2023, proposed revisions are included in our decision file.

The Act (16 U.S.C. 1531 et seq. ) 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 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 of 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 of time 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 the 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.

We considered the threats of habitat loss and degradation and tourism and development, along with demographic factors of pygmy sloths, and determined the foreseeable future to be approximately 30 years. This timeline for the foreseeable future is based on several factors. The pygmy sloth generation time is estimated to be between 6 and 10 years, and similar species only have one offspring per pregnancy. Thus, the demographic responses of the species to the identified threats will materialize rapidly across just a few (<5) generations. This determination of foreseeable future being 30 years assumes enough time will pass for three to five generations of cohorts to represent the population's resiliency to the identified threats. Thirty years will also include time for climate change and development to progress, as well as for conservation activities affecting Escudo to develop. We are very confident in the predictions from our climate models out to this time step. Although there is uncertainty in specific rates and strengths of the impacts from development and tourism over this time step, we are confident in the negative effects these threats will have on pygmy sloth. We have information showing that nearby coastal development plans are in place, roads providing access to the coastlines are being built, and conservation capacity within the area is limited. This information combined with demographics of this species gives us confidence that within a 30-year future, these threats will negatively impact the pygmy sloth. Therefore, based on the best scientific and commercial data available, we conclude that over a period of 30 years we can make reliable predictions that both the future threats to the species and the species' response to those threats are likely.

The SSA report documents the results of our comprehensive biological review of the best scientific and commercial data regarding the status of the species, including an assessment of the potential threats to the species. The SSA report does not represent our decision on whether the species should be proposed for listing as an endangered or threatened species under the Act. However, it does 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.

To assess pygmy sloth viability, we used the three conservation biology principles of resiliency, redundancy, and representation (Shaffer and Stein 2000, pp. 306-310). Briefly, resiliency is the ability of the species to withstand environmental and demographic stochasticity (for example, wet or dry, warm or cold years); redundancy is the ability of the species to withstand catastrophic events (for example, droughts, large pollution events); and representation is the ability of the species to adapt to both near-term and long-term changes in its physical and biological environment (for example, climate conditions, pathogens). In general, species viability will increase with increases in (or decrease with decreases in) resiliency, redundancy, and representation (Smith et al. 2018, p. 306). 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 the 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 of 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, which we then used to inform our regulatory decision.

The following is a summary of the key results and conclusions from the SSA report; the full SSA report can be found at Docket FWS-HQ-ES-2023-0151 on https://www.regulations.gov.

In this discussion, we review the biological condition of the species and its 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.

Based on the species' biology described above and in the SSA report (version 1.1; Service 2023, pp. 1-8), the pygmy sloth requires food plants, intact and connected forest habitats, and sufficient conspecific individuals to find a mate. Threats to the sloth's viability include the small extent (4.3 km 2 ) of Escudo (as noted above, pygmy sloths in the wild are found only on this one small island in Panama), the naturally limited size of the species' single population, direct and indirect impacts of tourism, habitat loss from small-scale timber harvest, and habitat loss from sea-level rise and erosion. Together, these threats make the pygmy sloth vulnerable to random declines due to demographic stochasticity, environmental catastrophes ( e.g., storms), or both.

Small-scale but continuing harvest of red mangroves and interior forest trees occurs on Escudo for construction of temporary huts used by fishermen and for timber for tourism development in nearby regions (Feller 2022, pers. comm.; ZSL 2017, p. 16). Continued forest loss would eventually lead to a reduced pygmy sloth population, but the lack of good information on pygmy sloth movements and densities, and their relative reliance on mangrove versus interior forest, currently prohibits determination of that threshold. Evidence from urban populations of related species indicates three-toed sloth species may be relatively resilient to life in small forest fragments (Service 2023, p. 6; Pool et al. 2016, pp. 26-30), but it is not clear whether this extends to the pygmy sloth.

As the nearby coastal regions of the Bocas del Toro, Veraguas, and Ngobe-Bugle provinces grow in popularity with local and especially foreign tourists, so too has the volume of visits to Escudo and the demand for infrastructure there (ZSL 2017, pp. 3, 17). Both Panamanians and foreign investors are interested in developing the island and nearby region for greater tourism commercialization (Smith 2021, pers. comm.; Voirin 2021, pers. comm; Voirin 2015, pp. 706-707). Although Panama has a mandatory environmental-impact-assessment process (Gonzalez 2008, pp. 320-327), reviews are sometimes diminished by demand for development ( e.g., Gonzalez 2008, pp. 328-333) and often initiated too late in a project's progression to revise plans or prevent identified environmental harms (Jordan 2021, pers. comm.). Consultations between government environmental authorities and developers can be rapid and leave little room for adjustment of project plans (Jordan 2021, pers. comm.).

Coastal development and construction of major roads and ports on the nearby mainland has improved and will continue to improve accessibility, making the trip to Escudo easier for many more people (Smith 2021, pers. comm.; Voirin 2021, pers. comm.; Oberle and Rodriguez 2020, entire; Bilbao 2017, unpaginated). While little is known of the impacts of increased human presence on the island to pygmy sloth behavior and ecology, increased tourism, particularly when combined with inadequate regulatory mechanisms and enforcement, is likely to lead to direct and indirect impacts on sloth viability through up-close encounters, deforestation, habitat degradation, increased litter and refuse, as well as the potential to increase the introduction of pests, invasive species, and disease.

Desire for up-close or in-hand photos of pygmy sloths will likely increase along with tourist visitation as global popularity of sloths and demand for pet and zoo-housed sloths has grown tremendously (Voirin 2015, p. 706). The risk of sloths being illegally taken and smuggled away from Escudo into domestic and international trade for personal and commercial purposes is greater as more unregulated visitors reach the island (Jordan 2021, pers. comm.; Voirin 2021, pers. comm.). This is despite three-toed sloths rarely surviving more than several months in captivity and a general lack of knowledge regarding husbandry techniques for three-toed sloths (Voirin et al. 2014a, p. 2; Espinoza and Cliffe 2013, p. 4; Raines 2005, p. 557).

While there is currently little legal international trade of the species, there are several examples of known trade or attempts to trade specimens of pygmy sloth. In 2013, 11 individuals were taken from the wild with the intent to export to the United States for zoological purposes, but the attempted export was stopped by protesters at the Bocas del Toro Airport (Espinoza and Cliffe 2013, p. 4). These individual pygmy sloths were soon after returned to Escudo, but at least two died after reintroduction to the island (Superina 2022, pers. comm.). Additionally, eight wild-sourced specimens of pygmy sloth originating from Panama were legally exported from the United States to Portugal for scientific purposes in 2015. In 2021, there was at least one trade transaction of a specimen from China to the Netherlands, but the involved specimen was recorded as a CITES pre- Convention specimen, meaning the specimen was acquired (removed from the wild or born in a controlled environment) before the date the species was first included in the CITES Appendices (July 1, 1975), and therefore we presume it to be a non-living specimen.

In general, Escudo and its surroundings have very limited government presence or regulatory enforcement because of the remote location and Escudo's semi-autonomous nature as an Indigenous-inhabited territory that is administered by the Bocas del Toro province. While smaller scale, Indigenous-led pygmy sloth tourism has been less disruptive than the more industrial form (Voirin 2021, pers. comm.), the permit requirements for tourists to visit the island are not enforced (ZSL 2017, pp. 17-18). Small-scale tourist operations are also likely to be outcompeted by larger organizations entering the market. Although large-scale tourism has not yet reached Escudo as it has in the surrounding archipelago, tourism is steadily increasing and tourist boats arrive without notice and are reportedly damaging coral reefs and sea turtle nesting grounds (Smith 2021, pers. comm.), indicative of at least some operators' lack of concern for or knowledge about harm to the island's ecology.

Finally, as sea levels rise due to global climate change, the extent of the pygmy sloth's island habitats may be reduced (Intergovernmental Panel on Climate Change (IPCC) 2019, pp. 6-13). Any loss of habitat area on the already small island could reduce the number of sloths supported on Escudo. Anecdotally, erosion has been increasing on Escudo (Smith 2021, pers. comm.), although its extent is not quantified, and it is not known whether this is due to sea-level rise, storms, coastal deforestation, or other human-caused shoreline disturbance.

The Pygmy Sloth Conservation Project, established in 2011 by ZSL's EDGE of Existence Program, is employing innovative and integrative activities to support pygmy sloth and Escudo conservation (ZSL 2017, entire). The project includes repeated population surveys, education of Indigenous communities and schoolchildren regarding Escudo ecology and the benefits of conservation, and cooperation with the Indigenous government and local fishermen's association to develop a community-based natural-resources-management program (ZSL 2017, pp. 19-27).

In June 2022, a workshop was held in collaboration with the Ministry of Environment and the Ngäbe-Buglé indigenous authorities to develop a management plan for the conservation of the pygmy sloth (Smith 2022, pers. comm.). The information generated by this pygmy sloth conservation action plan is expected to also serve as the basis for a future comprehensive management plan for Escudo, but as of the publication of this proposed rule, that plan has not yet been developed (Smith 2022, pers. comm.).

As of 2017, the national Ministry of the Environment could not afford to visit Escudo independently (ZSL 2017, p. 18). Consequently, there is no evidence available to the Service of enforcement of tourism permit requirements or anti-littering and deforestation laws. Escudo is designated as a protected area with management shared between the national Ministry of the Environment and the local Indigenous council (Voirin et al. 2014a, p. 5), but in 2012, the island was classified as open to tourism, as well as scientific, entertainment, and cultural development, so the benefits of the protected-area designation are limited (Voirin 2015, pp. 706-707).

Pygmy sloths are included in CITES Appendix II, and international trade in any specimen of the species requires inter alia a valid CITES document that authorizes trade in the specimen to accompany the specimen. CITES export permits may only be issued by the exporting country's CITES Management Authority after a legal acquisition finding is made by the exporting country's CITES Management Authority and a non-detriment finding is made by the exporting country's CITES Scientific Authority (for additional information about CITES requirements, see 50 CFR part 23). On May 5, 2023, CITES Notification No. 2023/057 notified all Parties to CITES that Panama has suspended the issuance of all exports for specimens harvested from the wild for commercial purposes, including the pygmy sloth, until scientific non-detriment findings are completed (CITES 2023, unpaginated).

We assess the pygmy sloth's resiliency using two criteria: a population-abundance criterion and a forest-extent criterion. We incorporate the knowledge that the species has likely always been rare by basing the population abundance criterion on detection of a population decline in addition to considering absolute abundance, as rarer species are at elevated risk of extinction even if the rarity is natural (Flather and Sieg 2007, entire; Johnson 1998, entire). The forest-extent criterion subsumes the pygmy sloth's requirements for shelter, connectivity, and native food plants.

Considering these two resiliency criteria to account for the species' demographic and habitat requirements, we determined thresholds for high, medium, and low resiliency for the pygmy sloth. High resiliency would indicate a high probability of population viability with minimal to no declines in population size. Moderate resiliency would indicate the species has experienced possible population declines. Low resiliency would indicate low probability of population viability with certain population decline.

While it is difficult to estimate the true size of the population due to the challenge of detecting (and therefore counting) pygmy sloths (Voirin 2015, p. 705), the most recent estimate of the total pygmy sloth population size is 2,000-2,500 individuals, and the population is estimated to be declining (Smith et al. 2022, unpaginated). The most recently available population trend data from mangrove surveys in 2014-2017 show no change in encounter rate of sloths, although the uncertainty in abundance is large (ZSL 2017, p. 13). All estimates indicate an extremely small number for an entire species (Smith et al. 2022, unpaginated).

Based on our assessment of deforestation from 2000-2020, only 0.11 percent of forested area in 2000 (totaling 3.95 km 2 ) was deforested by 2020 (data from Hansen et al. 2013, unpaginated; Service 2023, pp. 14-16). This assessment, however, is based on satellite data (approximately 30 meters (m) resolution) and does not detect partial clearings. While ground-based mapping of deforestation events shows partial tree clearing has occurred on Escudo (ZSL 2017, p. 16) and a recently published assessment indicates habitat degradation has resulted in a continuing decline in the quality of pygmy sloth habitat (Smith et al. 2022, unpaginated), our assessment indicates the forest extent on Escudo remains mostly intact.

We assess that the pygmy sloth presently has moderate-to-high resiliency, because the best available data indicate that pygmy sloth abundance and the extent of habitat available on Escudo have not considerably declined, but there remains substantial uncertainty in these estimates.

With no captive individuals and only one wild population located on an island less than 5 km 2 in extent, the pygmy sloth naturally has very low redundancy. Although very few large cyclones and storms reach Escudo, it is seismically active, and loss of the Escudo population would equate to global extinction.

With respect to representation, the isolation of a small number of founder individuals when the pygmy sloth separated from the mainland population of brown-throated sloths (likely around 9,000 years ago; Anderson and Handley 2001, p. 4) would have created a natural genetic bottleneck (a sharp decrease in a population's genetic diversity as a result of a reduction in population size; Silva 2013, p. 138). Today, genetic variation in the population is low (Silva et al. 2018, p. 1301), and because the pygmy sloth only inhabits Escudo, the habitats it uses have little ecological variation. For these reasons, we consider the pygmy sloth's ability to adapt to changing environments, and thus its representation, to be naturally low.

Based on our assessment, we concluded that two important potential threats to pygmy sloth viability in the future are: (1) increased development and tourism around—and visitation to—the island, together with the increased likelihood of illegal taking and trade in the species, and (2) increased habitat loss and degradation caused by deforestation and inundation of Escudo.

In the SSA report, we forecast the species' status under two alternative future scenarios and six climate-change projections (encompassing the uncertainty in sea-level-rise trajectories) to determine how deforestation, the demand for sloths in the pet and tourism market, and the potential for the already small extent of Escudo to be further reduced by rising sea level would affect the species. Specifically, our scenarios include “status quo” and “improved conservation capacity” alternatives to assess the potential impacts of growing development and tourism. For each of these two scenarios, we assessed six climate-change projections to help encompass the uncertainty in sea-level-rise trajectories for the year 2050. This is approximately 30 years from this proposed listing and would include time for climate change and development to progress, as well as for conservation activities affecting Escudo to grow. Based on studies from other three-toed sloth species, this 30-year timeframe will include around three to five generations of pygmy sloths (Anderson and Handley 2002, p. 1051).

A comprehensive understanding of the current and future conditions of tourism on Escudo is currently lacking due to uncertainty in plans for imminent coastal development and the inherent difficulty of monitoring and enforcing regulations because of the remote nature of the island and lack of funding for enforcement. Observational accounts indicate that although large tourism operations are not currently reaching Escudo, the amount of tourism arriving to the island is increasing, and, if the planned development of the nearby remote coastline occurs, tourism, including from large outfitters, will likely increase in volume (Jordan 2021, pers. comm.; Smith 2021, pers. comm.; Voirin 2021, pers. comm.).

International tourist visitation to Panama grew by 150 percent between 2000 and 2008, and nature-based tourism is an increasing portion of Panama's economy (Beaton and Hadzi-Vazkov 2017, pp. 23-29). Tourism grew fast in the coastal and island regions of Bocas Del Toro province (to which Escudo belongs) from the 1990s onwards, including growing accessibility to vast stretches of beach and rainforest. For instance, beginning in 2004 and continuing into at least 2017, a major road was under construction from Santa Fe to the coastal city of Calovebora in northern Veraguas province (Bilbao 2017, unpaginated). The road's route is a major new access point to undeveloped areas within easy boating distance of Escudo (Bilbao 2017, unpaginated). Additionally, developers have for several years been amassing land holdings in the regions near Escudo, and they may be planning for the resale of lots for future homes and hotels (Jordan 2021, pers. comm).

As additional people move to and visit the region, the very strong demand for sloths taken from the wild for tourists' “sloth selfies” or for sale into the pet trade (Greenfield 2020, unpaginated) will likely impact pygmy sloths (Voirin 2021, pers. comm.; Jordan 2021, pers. comm.). For example, other sloth species are illegally collected from the wild in Colombia for hands-on tourism or illegal pet trade (Gorder 2021, unpaginated; Moreno and Plese 2006, p. 12).

The General Law on Environment of the Republic of Panama (Article 23 of Law No. 41 (1998)) requires that public or private projects, including tourism developments, be vetted through an environmental-impact-assessment (EIA) process administered by the national Ministry of the Environment (Gonzalez 2008, p. 324; Bethancourt 2000, unpaginated). In practice, however, developers often do not file for an EIA or do so very late in the project's progress, which makes substantive changes to the project challenging (Jordan 2021, pers. comm.). Consultations that do take place, particularly in remote locations, are frequently cursory (Jordan 2021, pers. comm.).

By 2050 under the status quo alternative, if the lack of environmental law enforcement capacity in the remote Escudo region (ZSL 2017, p. 18) continues, the limitations of Panama's EIA process are not rectified, and the unplanned nature of regional development (Jordan 2021, pers. comm.) persists, modest to large declines in the species' population are likely. These declines are likely due to the stresses of increased visitation to Escudo (including up-close encounters), habitat degradation, and illegal poaching to meet the demand for the pet and zoo trade domestically and internationally.

If, on the other hand, the ongoing conservation efforts (see Conservation Efforts and Regulatory Mechanisms, above) lead to improved conservation capacity around Escudo, pygmy sloth population declines would be less likely to occur. A future with improved conservation capacity would include the regular presence of well-equipped conservation officers from the national Ministry of the Environment or Indigenous governments or both, and only sustainable, well-regulated tourist visits to Escudo with no pygmy sloths captured or disturbed. A completed management plan would include enforcement of specific limitations on the volume and activities of tourists and others to avoid pygmy sloth collection and deforestation. While ongoing work to support pygmy sloth conservation (see Conservation Efforts and Regulatory Mechanisms, above) indicates this is a possible future scenario, given the historical and ongoing challenges of regulation and enforcement on Escudo, this outcome is less likely than the status quo scenario.

Given its small island habitat, the pygmy sloth's viability is sensitive to the potential for further reduction in the available areas on Escudo, for example losses due to sea-level rise and deforestation. To assess the impacts of sea-level rise, we used climate models forecasting where land presently above water will be lost due to sea-level rise. We used these data to project the extent of pygmy sloth habitat expected to be lost under different climate-change scenarios. Specifically, we included six alternative climate trajectories defined by the (1) degree of greenhouse-gas emissions reduction achieved (three representative concentration pathways (RCPs), RCPs 2.6, 4.5, and 8.5) by 2050, and (2) two different rates of Antarctic ice-sheet melting, an uncertain but potentially major contributor to global sea-level rise (Kulp and Strauss 2018, p. 2; Kopp et al. 2017, entire; Kopp et al. 2014, entire).

The RCPs are Intergovernmental Panel on Climate Change (IPCC) scenarios that describe alternative future trajectories of greenhouse gas emissions and that are used to drive climate-model projections in response to higher or lower future emission rates (IPCC 2014, p. 8). In the RCP names, the values 2.6, 4.5, and 8.5 refer to the rate at which energy is trapped by Earth's atmosphere in watts per square meter (m 2 ) at the height of warming for the given scenario; thus, RCP 8.5 is a scenario indicating faster warming than RCP 4.5. RCP 8.5 is considered a “high-emission business as usual scenario,” i.e., towards the upper end of what might occur without climate-change mitigation policy (Riahi et al. 2011, p. 54). RCP 4.5 is based on a lower-emissions future in which renewable energy, greater energy efficiency, and carbon capture and storage are more widely implemented (Thomson et al. 2011, p. 77). RCP 2.6 represents stringent cuts to greenhouse gas emissions sufficient to limit warming to 2 degrees Celsius (°C) (van Vuuren et al. 2011, entire).

The extent of Escudo habitat inundated by 2050 ranged from 0.04 percent (RCP 2.6, no rapid West Antarctic melting) to 0.08 percent (RCP 8.5, rapid West Antarctic melting; Service 2023, p. 20). Even if we assumed for the most pessimistic scenario (0.08 percent of the entire island inundated) that the entirety of the inundated habitat was concentrated within the 2.5 percent of the island that is mangrove forests, only slightly more than 3 percent of the mangroves would be inundated. However, although inundation is focused on coastal edges of the island and includes some locations on the north coast where mangroves grow, part of the inundation will occur outside the mangroves, so the 3 percent figure is likely an overestimate. Moreover, red mangroves can possibly keep pace with sea-level rise by growing taller and accumulating peat beneath their stilt roots (Mckee et al. 2007, entire; Feller 2021, pers. comm.). The interior forest habitat is more extensive than mangroves (ZSL 2017, p. 11) and, when compared to estimates for mangrove forests, less interior forest habitat is projected to be lost as a result of sea-level rise. Thus, we project that loss of habitat due to sea-level rise will be at most 3 percent across mangrove and interior forest habitats.

Deforestation presents a second potential cause of habitat loss and degradation. Forecasting future rates of deforestation is difficult due to the discrepancies between ground observations and satellite data of deforestation, as well as the unknown impact that, if implemented, development plans and potential subsequent tourism increases might have on deforestation. Under a status quo future, deforestation may continue as it occurs now, at low and consistent levels, or it may increase, given the interest expressed by some Indigenous people in living on Escudo and the expansion of tourism and associated infrastructure development on the island. With improved conservation capacity, including increased monitoring and enforcement of land use of the island, we project that deforestation levels would be low.

Regardless of the climate-change scenario, if the conservation capacity around Escudo does not improve ( i.e., if it remains at the status quo), the total resilience of the pygmy sloth is projected to decline, likely falling into the moderate-to-low-resiliency category, and potentially falling into the low-resiliency category. If conservation capacity is improved around Escudo, we project that the pygmy sloth's resiliency could improve despite the species' natural rarity. However, high uncertainty exists in both current and future resiliency due to the limited data available on population abundance, rates of deforestation, and effects of tourism and development on the species. Additionally, given the historical and current lack of regulatory and enforcement capacity, outcomes under the improved-conservation-capacity scenario, although possible, are less likely than those under the status quo scenario.

Redundancy is not projected to change under any of the future scenarios; we expect there to remain only the single Escudo population. Representation may remain the same or may decrease if tourists arriving at the relatively accessible island edge and beaches stress pygmy sloths into retreating into the interior forest and reduce the habitat types pygmy sloths use, further limiting the species' adaptive potential.

We note that, by using the SSA framework to guide our analysis of the scientific information documented in the SSA report, we have analyzed the cumulative effects of identified threats and conservation actions on the species. To assess the current and future condition of the species, we evaluate the effects of all the relevant factors that may be influencing the species, including threats and conservation efforts. Because the SSA framework considers not just the presence of the factors, but to what degree they collectively influence risk to the entire species, our assessment integrates the cumulative effects of the factors and replaces a standalone cumulative-effects analysis.

Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for determining whether a species meets the definition of an endangered species or a threatened species. The Act defines an “endangered species” as a species in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species 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 a species meets the definition of 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.

After evaluating threats to the species and assessing the cumulative effect of the threats under the Act's section 4(a)(1) factors, we determined that the future viability of the pygmy sloth will be reduced as ongoing and future development on the mainland nearest Escudo increases accessibility to the island, likely reducing the pygmy sloth's resiliency, which along with its naturally low redundancy and representation will likely compromise the security of the species' continued existence within the foreseeable future.

The pygmy sloth is a narrow endemic species with a small population and very limited range. Given the pygmy sloth's rarity and low genetic diversity, the species has naturally low representation and redundancy. While tourism and small-scale timber harvest are ongoing in the species' range, the pygmy sloth is not currently at risk of extinction because it maintains moderate-to-high resiliency with a variety of age classes and evidence of reproduction, and while it is naturally restricted to the very small island of Escudo, its habitat requirements do not currently appear to be limiting. Although the species currently is not at risk of extinction, threats to the species are expected to increase in the foreseeable future. Ongoing and anticipated development on the nearby mainland will facilitate increased access to Escudo, increasing disturbance to pygmy sloths through deforestation, up-close interactions, and illegal taking and smuggling into domestic and international trade for personal and commercial purposes. While there are regulatory mechanisms in place to protect against these threats, enforcement in the species' relatively remote range is limited and is likely inadequate to reduce the impacts of increased tourism and deforestation. The current population of the pygmy sloth is estimated to be declining, and the likely increase of threats in the foreseeable future will reduce the species' viability to a point that it is likely to lack sufficient resiliency, representation, and redundancy for its continued existence to be secure.

Thus, after assessing the best available information, we conclude that the pygmy sloth is not currently in danger of extinction but is likely to become in danger of extinction within the foreseeable future throughout all of its range due to increased threats from tourism and development that will likely lead to habitat loss and degradation (Factor A), overutilization in a variety of forms from increasing human interactions (Factor B), and the inadequacy of existing regulatory mechanisms (Factor D).

Under the Act and our implementing regulations, a species may warrant listing if it is in danger of extinction or likely to become so within the foreseeable future throughout all or a significant portion of its range. The court in Center for Biological Diversity v. Everson, 435 F. Supp. 3d 69 (D.D.C. 2020) ( Everson ), vacated the provision of the Final Policy on Interpretation of the Phrase “Significant Portion of Its Range” in the Endangered Species Act's Definitions of “Endangered Species” and “Threatened Species” (hereafter “Final Policy”; 79 FR 37578, July 1, 2014) that provided if the Service determines that a species is threatened throughout all of its range, the Service will not analyze whether the species is endangered in a significant portion of its range.

Therefore, we proceed to evaluating whether the species is endangered in a significant portion of its range—that is, whether there is any portion of the species' range for which both (1) the portion is significant; and (2) the species is in danger of extinction in that portion. Depending on the case, it might be more efficient for us to address the “significance” question or the “status” question first. We can choose to address either question first. Regardless of which question we address first, if we reach a negative answer with respect to the first question that we address, we do not need to evaluate the other question for that portion of the species' range.

Following the court's holding in Everson, we now consider whether there are any significant portions of the species' range where the species is in danger of extinction now ( i.e., endangered). In undertaking this analysis for pygmy sloth, we choose to address the status question first—we consider information pertaining to the geographic distribution of both the species and the threats that the species faces to identify portions of the range where the species may be endangered.

We evaluated the range of the pygmy sloth to determine if the species is in danger of extinction now in any portion of its range. The pygmy sloth is a narrow endemic that functions as a single, contiguous population and occurs entirely within a 4.3 km 2 island. Thus, there is no biologically meaningful way to break this limited range into portions, and the threats that the species faces affect the species throughout its entire range. As a result, there are no portions of the species' range where the species has a different biological status from its rangewide biological status. Therefore, we conclude that there are no portions of the species' range that warrant further consideration, and the species is not in danger of extinction in any significant portion of its range, and we determine that the species is likely to become in danger of extinction within the foreseeable future throughout all of its range. This does not conflict with the courts' holdings in Desert Survivors v. U.S. Department of the Interior, 321 F. Supp. 3d 1011, 1070-74 (N.D. Cal. 2018), and Center for Biological Diversity v. Jewell, 248 F. Supp. 3d 946, 959 (D. Ariz. 2017), because, in reaching this conclusion, we did not apply the aspects of the Final Policy, including the definition of “significant” that those court decisions held to be invalid.

Our review of the best available scientific and commercial information indicates that the pygmy sloth meets the Act's definition of a threatened species. Therefore, we propose to list the pygmy sloth as a threatened species in accordance with sections 3(20) and 4(a)(1) of the Act.

The purposes of the Act are to provide a means whereby the ecosystems upon which endangered species and threatened species depend may be conserved, to provide a program for the conservation of such endangered species and threatened species, and to take such steps as may be appropriate to achieve the purposes of the treaties and conventions set forth in the Act. Under the Act, a number of steps are available to advance the conservation of species listed as endangered or threatened species. As explained further below, these conservation measures include: (1) recognition, (2) recovery actions, (3) requirements for Federal protection, (4) financial assistance for conservation programs, and (5) prohibitions against certain activities.

Recognition through listing results in public awareness, as well as in conservation by Federal, State, Tribal, and local agencies, foreign governments, private organizations, and individuals. The Act encourages cooperation with the States and other countries and calls for recovery actions to be carried out for listed species.

Section 7 of the Act is titled, “Interagency Cooperation,” and it mandates all Federal action agencies to use their existing authorities to further the conservation purposes of the Act and to ensure that their actions are not likely to jeopardize the continued existence of listed species or adversely modify critical habitat. Regulations implementing section 7 are codified at 50 CFR part 402.

Section 7(a)(2) states that each Federal action agency shall, in consultation with the Secretary, ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat.

A Federal “action” that is subject to the consultation provisions of section 7(a)(2) of the Act is defined in our implementing regulations at 50 CFR 402.02 as all activities or programs of any kind authorized, funded, or carried out, in whole or in part, by Federal agencies in the United States or upon the high seas. With respect to pygmy sloth, no known actions require consultation under section 7(a)(2) of the Act. Given the regulatory definition of “action,” which clarifies that it applies to activities or programs “in the United States or upon the high seas,” the pygmy sloth is unlikely to be the subject of section 7 consultations, because the entire life cycle of the species occurs in terrestrial areas outside of the United States and the species is unlikely to be affected by U.S. Federal actions. Additionally, no critical habitat will be designated for the species because, under 50 CFR 424.12(g), we will not designate critical habitat within foreign countries or in other areas outside of the jurisdiction of the United States.

Section 8(a) of the Act (16 U.S.C. 1537(a)) authorizes the provision of limited financial assistance for the development and management of programs that the Secretary of the Interior determines to be necessary or useful for the conservation of endangered or threatened species in foreign countries. Sections 8(b) and 8(c) of the Act (16 U.S.C. 1537(b) and (c)) authorize the Secretary to encourage conservation programs for foreign listed species, and to provide assistance for such programs, in the form of personnel and the training of personnel.

It is our policy, as published in the Federal Register on July 1, 1994 (59 FR 34272), to identify to the extent known at the time a species is listed, specific activities that will not be considered likely to result in violation of section 9 of the Act. To the extent possible, activities that will be considered likely to result in violation will also be identified in as specific a manner as possible. The intent of this policy is to increase public awareness of the effect of a proposed listing on proposed and ongoing activities within the range of the species proposed for listing. Although most of the prohibitions in section 9 of the Act apply to endangered species, sections 9(a)(1)(G) and 9(a)(2)(E) of the Act also prohibit the violation of any regulation issued under section 4(d) of the Act pertaining to any threatened species of fish or wildlife, or threatened species of plant, respectively. Section 9(g) additionally makes it illegal to attempt to commit, to solicit another to commit, or to cause to be committed any act prohibited under Section 9, including violations of a 4(d) rule. Section 4(d) of the Act grants the Secretary broad discretion to prohibit with respect to any threatened species any act prohibited under Section 9(a)(1), in the case of fish or wildlife, or section 9(a)(2), in the case of plants. Section 4(d) also directs the Secretary to promulgate protective regulations that are necessary and advisable for the conservation of threatened species. As a result, we interpret our policy to mean that, when we list a species as a threatened species, to the extent possible, we identify activities that will or will not be considered likely to result in violation of the protective regulations under section 4(d) for that species.

At this time, we are unable to identify specific activities that would or would not be considered likely to result in violation of section 9 of the Act beyond those included in the descriptions of proposed prohibitions and exceptions we would establish by protective regulation under section 4(d) of the Act (see II. Proposed Rule Issued Under Section 4(d) of the Act, below).

We may issue permits to carry out otherwise prohibited activities involving endangered and threatened wildlife species under certain circumstances. Regulations governing permits for threatened species are codified at 50 CFR 17.32, and general Service permitting regulations are codified at 50 CFR part 13. With regard to threatened wildlife, a permit may be issued for scientific purposes, to enhance the propagation or survival of the species, for incidental take in connection with otherwise lawful activities, for economic hardship, for zoological exhibition, for educational purposes, and for special purposes consistent with the purposes of the Act. The statute also contains certain exemptions from the prohibitions, which are found in sections 9 and 10 of the Act.

The Service may also register persons subject to the jurisdiction of the United States through its captive-bred wildlife (CBW) program if certain established requirements are met under the CBW regulations (see 50 CFR 17.21(g)). Through a CBW registration, the Service may allow a registrant to conduct certain otherwise prohibited activities under certain circumstances to enhance the propagation or survival of the affected species, including take; export or re-import; delivery, receipt, carriage, transport, or shipment in interstate or foreign commerce in the course of a commercial activity; or sale or offer for sale in interstate or foreign commerce. A CBW registration may authorize interstate purchase and sale only between entities that both hold a registration for the taxon concerned. The CBW program is available for species having a natural geographic distribution not including any part of the United States and other species that the Service Director has determined to be eligible by regulation. The individual specimens must have been born in captivity in the United States.

Separate from its proposed listing as a threatened species, as a CITES-listed species, all international trade of pygmy sloths by persons subject to the jurisdiction of the United States must also comply with CITES requirements pursuant to section 9, paragraphs (c) and (g), of the Act and to 50 CFR part 23. Applicable wildlife import/export requirements established under section 9, paragraphs (d), (e), and (f), of the Act; the Lacey Act Amendments of 1981 (16 U.S.C. 3371 et seq. ); and 50 CFR part 14 must also be met for pygmy sloth imports and exports. Questions regarding whether specific activities with pygmy sloths would constitute a violation of section 9 of the Act should be directed to the Service's Division of Management Authority ( managementauthority@fws.gov; 703-358-2104).

Section 4(d) of the Act contains two sentences. The first sentence states that the Secretary shall issue such regulations as she deems necessary and advisable to provide for the conservation of species listed as threatened species. The U.S. Supreme Court has noted that statutory language similar to the language in section 4(d) of the Act authorizing the Secretary to take action that she “deems necessary and advisable” affords a large degree of deference to the agency (see Webster v. Doe, 486 U.S. 592, 600 (1988)). Conservation is defined in the Act to mean the use of all methods and procedures which are necessary to bring any endangered species or threatened species to the point at which the measures provided pursuant to the Act are no longer necessary. Additionally, the second sentence of section 4(d) of the Act states that the Secretary may by regulation prohibit with respect to any threatened species any act prohibited under section 9(a)(1), in the case of fish or wildlife, or section 9(a)(2), in the case of plants. Thus, the combination of the two sentences of section 4(d) provides the Secretary with wide latitude of discretion to select and promulgate appropriate regulations tailored to the specific conservation needs of the threatened species. The second sentence grants particularly broad discretion to the Service when adopting one or more of the prohibitions under section 9.

The courts have recognized the extent of the Secretary's discretion under this standard to develop rules that are appropriate for the conservation of a species. For example, courts have upheld, as a valid exercise of agency authority, rules developed under section 4(d) that included limited prohibitions against takings (see Alsea Valley Alliance v. Lautenbacher, 2007 WL 2344927 (D. Or. 2007); Washington Environmental Council v. National Marine Fisheries Service, 2002 WL 511479 (W.D. Wash. 2002)). Courts have also upheld 4(d) rules that do not address all of the threats a species faces (see State of Louisiana v. Verity, 853 F.2d 322 (5th Cir. 1988)). As noted in the legislative history when the Act was initially enacted, “once an animal is on the threatened list, the Secretary has an almost infinite number of options available to [her] with regard to the permitted activities for those species. [She] may, for example, permit taking, but not importation of such species, or [she] may choose to forbid both taking and importation but allow the transportation of such species” (H.R. Rep. No. 412, 93rd Cong., 1st Sess. 1973).

The provisions of this proposed 4(d) rule would promote conservation of the pygmy sloth by ensuring that activities undertaken with the species by any person under the jurisdiction of the United States are also supportive of the conservation efforts undertaken for the species in Panama, as well as under the CITES Appendix-II listing. The provisions of this proposed rule are one of many tools that we would use to promote the conservation of the pygmy sloth. This proposed 4(d) rule would apply only if and when we make final the listing of the pygmy sloth as a threatened species.

As discussed above under Summary of Biological Status and Threats, we have concluded that the pygmy sloth is likely to become in danger of extinction within the foreseeable future primarily due to the impacts that nearby development and subsequent increased tourism will have on the species and its habitat. Under the proposed 4(d) rule, prohibitions and provisions that apply to endangered wildlife under section 9(a)(1) of the Act would help minimize threats that could cause further declines in the species' status.

Exercising the Secretary's authority under section 4(d) of the Act, we have developed a proposed rule that is designed to address the pygmy sloth's conservation needs. As discussed previously in Summary of Biological Status and Threats, we have concluded that the pygmy sloth is likely to become in danger of extinction within the foreseeable future primarily due to the impacts that nearby development and subsequent increased tourism will have on the species and its habitat. Section 4(d) requires the Secretary to issue such regulations as she deems necessary and advisable to provide for the conservation of each threatened species and authorizes the Secretary to include among those protective regulations any of the prohibitions that section 9(a)(1) of the Act prescribes for endangered species. We find that, if finalized, the protections, prohibitions, and exceptions in this proposed rule as a whole satisfy the requirement in section 4(d) of the Act to issue regulations deemed necessary and advisable to provide for the conservation of the pygmy sloth.

The protective regulations we are proposing for the pygmy sloth incorporate prohibitions from section 9(a)(1) to address the threats to the species. The prohibitions of section 9(a)(1) of the Act, and implementing regulations codified at 50 CFR 17.21, make it illegal for any person subject to the jurisdiction of the United States to commit, to attempt to commit, to solicit another to commit or to cause to be committed any of the following acts with regard to any endangered wildlife, unless they are otherwise authorized or permitted: (1) import into, or export from, the United States; (2) take within the United States, within the territorial sea of the United States, or on the high seas; (3) possess, sell, deliver, carry, transport, or ship, by any means whatsoever, any such wildlife that has been taken illegally; (4) deliver, receive, carry, transport, or ship in interstate or foreign commerce, by any means whatsoever and in the course of commercial activity; or (5) sell or offer for sale in interstate or foreign commerce. Certain exceptions to these prohibitions apply to employees or agents of the Service, the National Marine Fisheries Service, other Federal land management agencies, and State conservation agencies. Under the Act, “take” means to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct. Some of these provisions have been further defined in regulations at 50 CFR 17.3. Take can result knowingly or otherwise, by direct and indirect impacts, intentionally or incidentally. This protective regulation would provide for the conservation of the pygmy sloth by including all of these prohibitions because the pygmy sloth is at risk of extinction within the foreseeable future and putting these prohibitions in place would help to decrease synergistic, negative effects from other ongoing or future threats.

As discussed above under Summary of Biological Status and Threats, deforestation, tourism and development around Escudo, and collection for tourism, pet, and zoo demand are affecting the status of the pygmy sloth. Prohibiting take (which applies to take within the United States, within the territorial sea of the United States, or upon the high seas) would indirectly contribute to conservation of the species in its range country of Panama by helping to prevent attempts to captive-breed the species to establish a domestic market for trade of pygmy sloths. Collection of the species for tourism, zoo, and pet demand poses an ongoing threat to the species due to its limited range and small population size. Further regulating import and export to, from, and through the United States and foreign commerce by persons subject to the jurisdiction of the United States could deter breeding and demand for the species and help conserve the species by eliminating the United States as a potential market for illegally collected and traded pygmy sloths.

Despite these prohibitions regarding threatened species, we may under certain circumstances issue permits to carry out one or more otherwise-prohibited activities, including those described above. The regulations that govern permits for threatened wildlife state that the Director may issue a permit authorizing any activity otherwise prohibited with regard to threatened species. These include permits issued for the following purposes: for scientific purposes, to enhance propagation or survival, for economic hardship, for zoological exhibition, for educational purposes, for incidental taking, or for special purposes consistent with the purposes of the Act (50 CFR 17.32).

There are other standard exceptions to the prohibitions included in the proposed 4(d) rule for the pygmy sloth (see Proposed Regulation Promulgation, below), and the statute also contains certain exemptions from the prohibitions, which are found in sections 9 and 10 of the Act. If the species-specific 4(d) rule is finalized as proposed, the import exemption for threatened wildlife listed in Appendix II of CITES (50 CFR 17.8; section 9(c)(2) of the Act) would not apply to this species. A threatened species import permit under 50 CFR 17.32 would be required for the importation of all specimens of pygmy sloth. Further, as noted above, we may also authorize certain activities associated with conservation breeding under CBW registrations. We recognize that captive breeding of wildlife can support conservation, for example by producing animals that could be used for reintroductions. We are not aware of any captive-breeding programs of pygmy sloths for this purpose. The proposed 4(d) rule would apply to all live pygmy sloths and dead pygmy sloth parts and products and supports conservation management efforts for pygmy sloths in the wild in Panama.

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

(1) Be logically organized;

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

(3) Use clear language rather than jargon;

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

(5) Use lists and tables wherever possible.

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

We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act (42 U.S.C. 4321 et seq. ) need not be prepared in connection with listing a species as an endangered or threatened species under the Endangered Species Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

A complete list of references cited in this rulemaking is available on the internet at https://www.regulations.gov and upon request from the Branch of Delisting and Foreign Species (see FOR FURTHER INFORMATION CONTACT ).

The primary authors of this proposed rule are the staff members of the Fish and Wildlife Service's Species Assessment Team and the Branch of Delisting and Foreign Species.

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