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

The FAA will consider all comments received by the closing date for comments and will consider comments filed late if it is possible to do so without incurring delay. The FAA may change these special conditions based on the comments received.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in title 14, Code of Federal Regulations (14 CFR) 11.35, the FAA will post all comments received without change to www.regulations.gov, including any personal information, you provide. The FAA will also post a report summarizing each substantive verbal contact received about these special conditions.

Confidential Business Information (CBI) is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to these special conditions contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to these special conditions, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and the indicated comments will not be placed in the public docket of these special conditions. Send submissions containing CBI to the individual listed in the For Further Information Contact section. Comments the FAA receives, which are not specifically designated as CBI, will be placed in the public docket for these special conditions.

On July 5, 2022, Aerocon applied for a supplemental type certificate for the installation of a LDCRC in the Airbus Model A330-300 series airplane. The Airbus Model A330-300 series airplane is a twin-engine, transport-category airplane with a maximum takeoff weight of 533,518 pounds and maximum seating for 440 passengers.

Under the provisions of 14 CFR 21.101, Aerocon must show that the Airbus Model A330-300 series airplane, as changed, continues to meet the applicable provisions of the regulations listed in Type Certificate No. A46NM or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations ( e.g., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Airbus Model A330-300 series airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

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

In addition to the applicable airworthiness regulations and special conditions, the Airbus Model A330-300 series airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

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

The Airbus Model A330-300 series airplane will incorporate the following novel or unusual design feature:

Installation of a LDCRC under the passenger cabin floor in the cargo compartment.

Section 25.819 applies to lower deck service compartments (including galleys) but is not directly applicable to LDCRC. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. Special conditions are required for the certification of the LDCRC to supplement part 25.

The LDCRC will be located under the passenger cabin floor in the cargo compartment of the Airbus A330-330 model series airplane. It will be removable from the cargo compartment. Occupancy of the LDCRC will be limited to a maximum of eight crew members, and it will only be occupied in flight, i.e., not during taxi, takeoff, or landing. A smoke detection system, fire extinguishing system, oxygen system, and occupant amenities will be provided.

The LDCRC will be accessed from the main deck via a stair house. The floor within the stair house has an access hatch that leads to stairs, which occupants use to descend into the LDCRC. This hatch locks automatically in the open position when fully opened. In addition, there will be an emergency hatch, which opens directly into the main passenger cabin area. The LDCRC also has a maintenance access/ground loading door, which allows access to and from the cargo compartment. The intended use of this door is to allow cargo loading and maintenance personnel to enter the LDCRC from the cargo compartment when the airplane is on the ground, and not moving.

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

As discussed above, these proposed special conditions are applicable to the Airbus Model A330-300 series airplane for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same novel or unusual design feature, these special conditions would apply to the other model as well.

This action affects only certain novel or unusual design feature on one model A330-300 airplane. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The authority citation for these special conditions is as follows:

Accordingly, the Federal Aviation Administration (FAA) proposes the following special conditions as part of the type certification basis for Airbus Model A330-300 series airplanes as modified by Aerocon Engineering Company.

(a) Occupancy of the LDCRC is limited to a maximum of eight. There must be an approved seat or berth able to withstand the maximum flight loads when occupied for each occupant permitted in the crew rest compartment.

(1) There must be appropriate placards displayed in a conspicuous place at each entrance to the LDCRC compartment to indicate:

(i) The maximum number of occupants allowed.

(ii) That occupancy is restricted to crewmembers that are trained in the evacuation procedures for the crew rest compartment.

(iii) That occupancy is prohibited during taxi, take-off, and landing.

(iv) That smoking is prohibited in the crew rest compartment.

(v) That hazardous quantity of flammable fluids, explosives, or other dangerous cargo is prohibited from the crew rest compartment.

(vi) That the crew rest area must be limited to the stowage of crew personal luggage and must not be used for the stowage of cargo or passenger baggage.

(2) There must be at least one ashtray located conspicuously on or near the entry side of any entrance, usable in-flight, to the crew rest compartment.

(3) There must be a means to prevent passengers from entering the compartment in the event of an emergency or when no flight attendant is present.

(4) There must be a means for any door installed between the crew rest compartment and passenger cabin to be capable of being quickly opened from inside the compartment, even when crowding occurs at each side of the door.

(5) For all doors installed in the evacuation routes, there must be a means to preclude anyone from being trapped inside the compartment. If a locking mechanism is installed, it must be capable of being unlocked from the outside without the aid of special tools. The lock must not prevent opening from the inside of the compartment at any time.

(b) There must be at least two emergency evacuation routes, which could be used by each occupant of the crew rest compartment to rapidly evacuate to the main cabin and be able to be closed from the main passenger cabin after evacuation. In addition—

(1) The routes must be located with one at each end of the compartment, or with two having sufficient separation within the compartment and between the routes to minimize the possibility of an event (either inside or outside of the crew rest compartment) rendering both routes inoperative.

(2) The routes must be designed to minimize the possibility of blockage, which might result from fire, mechanical or structural failure, or persons standing on top of or against the escape route. If an evacuation route utilizes an area where normal movement of passengers occurs, it must be demonstrated that passengers would not impede egress to the main deck. If a hatch is installed in an evacuation route, the point at which the evacuation route terminates in the passenger cabin should not be located where normal movement by passengers or crew occurs (main aisle, cross aisle, passageway or galley complex). If such a location cannot be avoided, special consideration must be taken to ensure that the hatch or door can be opened when a person, the weight of a ninety-fifth percentile male, is standing on the hatch or door. The use of evacuation routes must not be dependent on any powered device. If there is low headroom at or near an evacuation route, provisions must be made to prevent or to protect occupants of the crew rest area from head injury.

(3) Emergency evacuation procedures, including the emergency evacuation of an incapacitated occupant from the crew rest compartment, must be established. All of these procedures must be transmitted to the operator for incorporation into their training programs and appropriate operational manuals.

(4) There must be a limitation in the airplane flight manual or other suitable means requiring that crewmembers be trained in the use of evacuation routes.

(c) There must be a means for the evacuation of an incapacitated person (representative of a 95th percentile male) from the crew rest compartment to the passenger cabin floor.

The evacuation must be demonstrated for all evacuation routes. A flight attendant or other crewmember (a total of one assistant within the crew rest area) may provide assistance in the evacuation. Additional assistance may be provided by up to three persons in the main passenger compartment. For evacuation routes having stairways, the additional assistants may descend down to one half the elevation change from the main deck to the lower deck compartment, or to the first landing, whichever is higher.

(d) The following signs and placards must be provided in the crew rest compartment:

(1) At least one exit sign, located near each exit, meeting the requirements of § 25.812(b)(1)(i) at Amendment 25-58, except that a sign with reduced background area of no less than 5.3 square inches (excluding the letters) may be utilized, provided that it is installed such that the material surrounding the exit sign is light in color ( e.g., white, cream, light beige). If the material surrounding the exit sign is not light in color, a sign with a minimum of a one-inch wide background border around the letters would also be acceptable.

(2) An appropriate placard located near each exit defining the location and the operating instructions for each evacuation route.

(3) Placards must be readable from a distance of 30 inches under emergency lighting conditions.

(4) The exit handles and evacuation path operating instruction placards must be illuminated to at least 160 micro lamberts under emergency lighting conditions.

(e) There must be a means in the event of failure of the aircraft's main power system, or of the normal crew rest compartment lighting system, for emergency illumination to be automatically provided for the crew rest compartment.

(1) This emergency illumination must be independent of the main lighting system.

(2) The sources of general cabin illumination may be common to both the emergency and the main lighting systems if the power supply to the emergency lighting system is independent of the power supply to the main lighting system.

(3) The illumination level must be sufficient for the occupants of the crew rest compartment to locate and transfer to the main passenger cabin floor by means of each evacuation route.

(4) The illumination level must be sufficient with the privacy curtains in the closed position for each occupant of the crew rest to locate a deployed oxygen mask.

(f) There must be means for two-way voice communications between crewmembers on the flight deck and occupants of the crew rest compartment. There must also be public address (PA) system microphones at each flight attendant seat required to be near a floor level exit in the passenger cabin per § 25.785(h) at Amendment 25-51. The PA system must allow two-way voice communications between flight attendants and the occupants of the crew rest compartment, except that one microphone may serve more than one exit provided the proximity of the exits allows unassisted verbal communication between seated flight attendants.

(g) There must be a means for manual activation of an aural emergency alarm system, audible during normal and emergency conditions, to enable crewmembers on the flight deck and at each pair of required floor level emergency exits to alert occupants of the crew rest compartment of an emergency situation. Use of a public address or crew interphone system will be acceptable, provided an adequate means of differentiating between normal and emergency communications is incorporated. The system must be powered in flight, after the shutdown or failure of all engines and auxiliary power units (APU), or the disconnection or failure of all power sources dependent on their continued operation ( i.e., engine & APU), for a period of at least ten minutes.

(h) There must be a means, readily detectable by seated or standing occupants of the crew rest compartment, which indicates when seat belts should be fastened. In the event there are no seats, at least one means must be provided to cover anticipated turbulence ( e.g., sufficient handholds). Seat belt type restraints must be provided for berths and must be compatible for the sleeping attitude during cruise conditions. There must be a placard on each berth requiring that seat belts must be fastened when occupied. If compliance with any of the other requirements of these special conditions is predicated on specific head location, there must be a placard identifying the head position.

(i) In lieu of the requirements specified in § 25.1439(a) at Amendment 25-38 that pertain to isolated compartments and to provide a level of safety equivalent to that which is provided occupants of a small, isolated galley, the following equipment must be provided in the crew rest compartment:

(1) At least one approved hand-held fire extinguisher appropriate for the kinds of fires likely to occur.

(2) Two protective breathing equipment (PBE) devices approved to Technical Standard Order (TSO)-C116 or equivalent, suitable for firefighting, or one PBE for each hand-held fire extinguisher, whichever is greater.

(3) One flashlight.

(j) A smoke or fire detection system (or systems) must be provided that monitors each occupiable area within the crew rest compartment, including those areas partitioned by curtains. Flight tests must be conducted to show compliance with this requirement. Each system (or systems) must provide:

(1) A visual indication to the flight deck within one minute after the start of a fire;

(2) An aural warning in the crew rest compartment; and

(3) A warning in the main passenger cabin. This warning must be readily detectable by a flight attendant, taking into consideration the positioning of flight attendants throughout the main passenger compartment during various phases of flight.

(k) The crew rest compartment must be designed such that fires within the compartment can be controlled without a crewmember having to enter the compartment, or the design of the access provisions must allow crewmembers equipped for firefighting to have unrestricted access to the compartment. The time for a crewmember on the main deck to react to the fire alarm, to don the firefighting equipment, and to gain access must not exceed the time for the compartment to become smoke-filled, making it difficult to locate the fire source.

(l) There must be a means provided to exclude hazardous quantities of smoke or extinguishing agent originating in the crew rest compartment from entering any other compartment occupied by crewmembers or passengers. This means must include the time periods during the evacuation of the crew rest compartment and, if applicable, when accessing the crew rest compartment to manually fight a fire. Smoke entering any other compartment occupied by crewmembers or passengers when the access to the crew rest compartment is opened, during an emergency evacuation, must dissipate within five minutes after the access to the crew rest compartment is closed.

(1) Hazardous quantities of smoke may not enter any other compartment occupied by crewmembers or passengers during subsequent access to manually fight a fire in the crew rest compartment (the amount of smoke entrained by a firefighter exiting the crew rest compartment through the access is not considered hazardous).

(2) There must be a provision in the firefighting procedures to ensure that all door(s) and hatch(es) at the crew rest compartment outlets are closed after evacuation of the crew rest compartment and, during firefighting to minimize smoke and extinguishing agent from entering other occupiable compartments.

(3) During the 1-minute smoke detection time, penetration of a small quantity of smoke from the crew rest compartment into an occupied area is acceptable. Flight tests must be conducted to show compliance with this requirement.

(4) If a built-in fire extinguishing system is used in lieu of manual firefighting, then the fire extinguishing system must be designed so that no hazardous quantities of extinguishing agent will enter other compartments occupied by passengers or crew. The system must have adequate capacity to suppress any fire occurring in the crew rest compartment, considering the fire threat, volume of the compartment and the ventilation rate.

(m) There must be a supplemental oxygen system equivalent to that provided for main deck passengers for each seat and berth in the crew rest compartment. The system must provide an aural and visual warning to warn the occupants of the crew rest compartment to don oxygen masks in the event of decompression. The warning must activate before the cabin pressure altitude exceeds 15,000 feet. The aural warning must sound continuously for a minimum of five minutes or until a reset push button in the crew rest compartment is depressed. Procedures for crew rest occupants in the event of decompression must be established. These procedures must be transmitted to the operator for incorporation into their training programs and appropriate operational manuals.

(n) The following requirements apply to crew rest compartments that are divided into several sections by the installation of curtains or partitions:

(1) To compensate for sleeping occupants, there must be an aural alert that can be heard in each section of the crew rest area compartment that accompanies automatic presentation of supplemental oxygen masks. A visual indicator that occupants must don an oxygen mask is required in each section where seats or berths are not installed. A minimum of two supplemental oxygen masks is required for each seat or berth. There must also be a means by which the oxygen masks can be manually deployed from the flight deck.

(2) A placard is required adjacent to each curtain that visually divides or separates, for privacy purposes, the crew rest area compartment into small sections. The placard must require that the curtain(s) remains open when the private section it creates is unoccupied.

(3) For each crew rest section created by the installation of a curtain, the following requirements of these special conditions must be met with the curtain open or closed:

(i) Emergency illumination (Special condition (e)).

(ii) Emergency alarm system (Special condition (g)).

(iii) Seat belt fasten signal or return to seat signal as applicable (Special condition (h)).

(iv) The smoke or fire detection system (Special condition (j)).

(4) Crew rest compartments visually divided to the extent that evacuation could be affected must have exit signs that direct occupants to the primary stairway exit. The exit signs must be provided in each separate section of the crew rest compartment and must meet the requirements of § 25.812(b)(1)(i) at Amendment 25-58. An exit sign with reduced background area as described in special condition (d)(1) may be used to meet this requirement.

(5) For sections within a crew rest compartment that are created by the installation of a partition with a door separating the sections, the following requirements of these special conditions must be met with the door open or closed:

(i) There must be a secondary evacuation route from each section to the main deck, or alternatively, it must be shown that any door between the sections has been designed to preclude anyone from being trapped inside the compartment. Removal of an incapacitated occupant within this area must be considered. A secondary evacuation route from a small room designed for only one occupant for short time duration, such as a changing area or lavatory, is not required. However, removal of an incapacitated occupant within this area must be considered.

(ii) Any door between the sections must be shown to be openable when crowded against, even when crowding occurs at each side of the door.

(iii) There may be no more than one door between any seat or berth and the primary stairway exit.

(iv) There must be exit signs in each section meeting the requirements of § 25.812(b)(1)(i) at Amendment 25-58 that direct occupants to the primary stairway exit. An exit sign with reduced background area as described in special condition (d).(1) may be used to meet this requirement.

(v) Special conditions (e) (emergency illumination), (g) (emergency alarm system), (h) (fasten seat belt signal or return to seat signal as applicable), and (j) (smoke or fire detection system) must be met with the door open or closed.

(vi) Special conditions (f) (two-way voice communication) and (i) (emergency firefighting and protective equipment) must be met independently for each separate section except for lavatories or other small areas that are not intended to be occupied for extended periods of time.

(o) Where a waste disposal receptacle is fitted, it must be equipped with a built-in fire extinguisher designed to discharge automatically upon occurrence of a fire in the receptacle.

(p) Materials (including finishes or decorative surfaces applied to the materials) must comply with the flammability requirements of § 25.853 at Amendment 25-66. Mattresses must comply with the flammability requirements of § 25.853(b) and (c) at Amendment 25-66.

(q) If a lavatory is installed, all lavatories within the crew rest are required to meet the same requirements as those for a lavatory installed on the main deck except with regard to special condition (j) for smoke detection.

(r) When a crew rest compartment is installed or enclosed as a removable module in part of a cargo compartment or is located directly adjacent to a cargo compartment without an intervening cargo compartment wall, the following applies:

(1) Any wall of the module (container) forming part of the boundary of the reduced cargo compartment, subject to direct flame impingement from a fire in the cargo compartment and including any interface item between the module (container), and the airplane structure or systems, must meet the applicable requirements of § 25.855 at Amendment 25-60.

(2) Means must be provided so that the fire protection level of the cargo compartment meets the applicable requirements of §§ 25.855 at amendment 25-60, 25.857 at amendment 25-60 and 25.858 at amendment 25-54 when the module (container) is not installed.

(3) Use of each emergency evacuation route must not require occupants of the crew rest compartment to enter the cargo compartment in order to return to the passenger compartment.

(4) The aural warning in special condition (g) must sound in the crew rest compartment in the event of a fire in the cargo compartment.

(s) Means must be provided to prevent access into the Class C cargo compartment during all airplane operations and to ensure that the maintenance door is closed during all airplane flight operations.

(t) All enclosed stowage compartments within the crew rest that are not limited to stowage of emergency equipment or airplane-supplied equipment ( e.g., bedding) must meet the design criteria given in the table below. As indicated by the table below, this special condition does not address enclosed stowage compartments greater than 200 ft 3 in interior volume. The in-flight accessibility of very large, enclosed stowage compartments and the subsequent impact on the crewmember's ability to effectively reach any part of the compartment with the contents of a hand fire extinguisher will require additional fire protection considerations similar to those required for inaccessible compartments such as Class C cargo compartments.

In this proposed rule, the Drug Enforcement Administration (DEA) proposes to schedule the following two controlled substances in schedule I of the Controlled Substances Act (CSA), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

• 2,5-dimethoxy-4-iodoamphetamine (DOI) and

• 2,5-dimethoxy-4-chloroamphetamine (DOC).

This proposed rule supersedes the April 11, 2022 notice of proposed rulemaking (NPRM) that DEA published in the Federal Register (87 FR 21069), to place DOI and DOC in schedule I of the CSA, which DEA withdrew on August 29, 2022 (87 FR 52712) in order to provide additional clarity on the process for submitting hearing requests. The scientific, medical, and other bases for the proposed placement of DOI and DOC in schedule I remain the same in this proposed rule as they were described in the April 2022 proposed rule, except for minor updates to certain data.

All comments received in response to this docket are considered part of the public record. DEA will make comments available, unless reasonable cause is given, for public inspection online at https://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want DEA to make it publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment.

DEA will generally make available in publicly redacted form comments containing personal identifying information and confidential business information identified, as directed above. If a comment has so much confidential business information that DEA cannot effectively redact it, DEA may not make available publicly all or part of that comment. Comments posted to https://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as confidential as directed above.

An electronic copy of this document and supplemental information to this proposed rule are available at https://www.regulations.gov for easy reference.

Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking “on the record after opportunity for a hearing.” Such proceedings are conducted pursuant to the provisions of the Administrative Procedure Act (APA), 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, subpart D. Interested persons may file requests for a hearing in conformity with the requirements of 21 CFR 1308.44(a) and 1316.47(a), and such requests must:

(1) state with particularity the interest of the person in the proceeding;

(2) state with particularity the objections or issues concerning which the person desires to be heard; and

(3) state briefly the position of the person with regarding to the objections or issues.

Any interested person may file a waiver of an opportunity for a hearing or to participate in a hearing in conformity with the requirements of 21 CFR 1308.44(c), together with a written statement of position on the matters of fact and law involved in any hearing. 21 CFR 1316.49.

All requests for a hearing and waivers of participation, together with a written statement of position on the matters of fact and law involved in such hearing, must be sent to DEA using the address information provided above. The decision whether a hearing will be needed to address such matters of fact and law in the rulemaking will be made by the Administrator. If a hearing is needed, DEA will publish a notice of hearing on the proposed rulemaking in the Federal Register . 21 CFR 1308.44(b), 1316.53. Further, once the Administrator determines a hearing is needed to address such matters of fact and law in rulemaking, she will then designate an Administrative Law Judge (ALJ) to preside over the hearing. The ALJ's functions shall commence upon designation, as provided in 21 CFR 1316.52.

In accordance with 21 U.S.C. 811 and 812, the purpose of a hearing would be to determine whether DOI and/or DOC meet the statutory criteria for placement in schedule I, as proposed in this rule.

The CSA provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General on his own motion. 21 U.S.C. 811(a). This proposed action is supported by a recommendation from the then-Assistant Secretary for Health of the Department of Health and Human Services (HHS).

In addition, regarding the placement of DOC in the Controlled Substances Act (CSA), the United States is a party to the 1971 United Nations Convention on Psychotropic Substances (1971 Convention), February 21, 1971, 32 U.S.T. 543, 1019 U.N.T.S. 175, as amended. Procedures respecting changes in drug schedules under the 1971 Convention are governed domestically by 21 U.S.C. 811(d)(2)-(4). When the United States receives notification of a scheduling decision pursuant to Article 2 of the 1971 Convention indicating that a drug or other substance has been added to a schedule specified in the notification, the Secretary of HHS (Secretary), 1 after consultation with the Attorney General, shall first determine whether existing legal controls under subchapter I of the CSA and the Federal Food, Drug, and Cosmetic Act meet the requirements of the schedule specified in the notification with respect to the specific drug or substance. 2 In the event that the Secretary did not consult with the Attorney General, and the Attorney General did not issue a temporary order, as provided under 21 U.S.C. 811(d)(4), the procedures for permanent scheduling set forth in 21 U.S.C. 811(a) and (b) control. Pursuant to 21 U.S.C. 811(a)(1) and (2), the Attorney General (as delegated to the Administrator of DEA), by rule, and upon the recommendation of the Secretary, may add to such a schedule or transfer between such schedules any drug or other substance, if he finds that such drug or other substance has a potential for abuse, and makes with respect to such drug or other substance the findings prescribed by 21 U.S.C. 812(b) for the schedule in which such drug or other substance is to be placed.

DOI and DOC belong to the phenethylamine class of drugs with hallucinogenic properties, similar to 2,5-dimethoxy-4-methamphetamine (DOM), a schedule I hallucinogen. DOI and DOC have no approved medical use in the United States.

On September 26, 2018, DEA, in accordance with the provisions of 21 U.S.C. 811(b), requested HHS provide a scientific and medical evaluation as well as a scheduling recommendation for DOI and DOC. Additionally, on May 7, 2020, the Secretary-General of the United Nations advised the Secretary of State of the United States that the Commission on Narcotic Drugs (CND), during its 63rd Session in March 2020, voted to place DOC in Schedule I of the 1971 Convention (CND Dec/63/4). As a signatory to this international treaty, the United States is required, by scheduling under the CSA, to place appropriate controls on DOC to meet the minimum requirements of the treaty.

Article 2, paragraph 7(a), of the 1971 Convention sets forth the minimum requirements that the United States must meet when a substance has been added to Schedule I of the 1971 Convention. The United States must adhere to specific export and import provisions that are provided in the 1971 Convention. This requirement is accomplished by the CSA with the export and import provisions established in 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312. Under Article 16, paragraph 4, of the 1971 Convention, the United States is required to provide annual statistical reports to the International Narcotics Control Board (INCB). Using INCB Form P, the United States shall provide the following information: (1) In regard to each substance in Schedule I and II of the 1971 Convention, quantities manufactured, exported to and imported from each country or region as well as stocks held by manufacturers; (2) in regard to each substance in Schedule III and IV of the 1971 Convention, quantities manufactured, as well as quantities exported and imported; (3) in regard to each substance in Schedule II and III of the 1971 Convention, quantities used in the manufacture of exempt preparations; and (4) in regard to each substance in Schedule II-IV of the 1971 Convention, quantities used for the manufacture of non-psychotropic substances or products. Lastly, under Article 2, paragraph 7(a)(vi) of the 1971 Convention, the United States must adopt measures in accordance with Article 22 to address violations of any statutes or regulations that are adopted pursuant to its obligations under the 1971 Convention. The United States complies with this provision as persons acting outside the legal framework established by the CSA are subject to administrative, civil, and/or criminal action.

Pursuant to 21 U.S.C. 811(b), DEA gathered the necessary data on DOI and DOC and on September 26, 2018, submitted it to the then-Assistant Secretary for Health of HHS with a request for a scientific and medical evaluation of available information and a scheduling recommendation for DOI and DOC. On September 28, 2020, HHS provided to DEA a scientific and medical evaluation entitled “Basis for the Recommendation to Control 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) and their Salts in Schedule I of the Controlled Substances Act (CSA)” and a scheduling recommendation. Following consideration of the eight factors and findings related to these substances' abuse potential, legitimate medical use, and dependence liability, HHS recommended that DOI and DOC and their salts be controlled in schedule I of the CSA under 21 U.S.C. 812(b). In response, DEA reviewed the scientific and medical evaluation and scheduling recommendation provided by HHS and all other relevant data, and completed its own eight-factor review pursuant to 21 U.S.C. 811(c).

After a review of the available data, including the scientific and medical evaluation and scheduling recommendation provided by HHS, the Administrator published an NPRM in the Federal Register on April 11, 2022 (87 FR 21069), to place DOI and DOC in schedule I of the CSA. DEA withdrew that proposed rule on August 29, 2022 (87 FR 52712). This proposed rule supersedes the April 2022 proposed rule, to provide additional clarity on the process for submitting hearing requests. The bases for the proposed placement of DOI and DOC in schedule I remain the same in this proposed rule as they were described in the April 2022 proposed rule.

Included below is a brief summary of each factor as analyzed by HHS and DEA in their respective eight-factor analyses, and as considered by DEA in the April 2022 proposed rule and in this proposed scheduling determination. Please note that both DEA and HHS analyses are available in their entirety under “Supporting Documents” of the public docket for this proposed rule at https://www.regulations.gov under docket number “DEA1156.”

In addition to considering the information HHS provided in its scientific and medical evaluation document for DOI and DOC, DEA also considered all other relevant data regarding actual or relative potential for abuse of DOI and DOC. The term “abuse” is not defined in the CSA; however, the legislative history of the CSA suggests the following four prongs in determining whether a particular drug or substance has a potential for abuse:  3

a. Individuals are taking the drug or other substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community; or

b. There is a significant diversion of the drug or other substance from legitimate drug channels; or

c. Individuals are taking the drug or other substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs; or

d. The drug is so related in its action to a drug or other substance already listed as having a potential for abuse to make it likely that it will have the same potential for abuse as such substance, thus making it reasonable to assume that there may be significant diversions from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community.

DEA reviewed the scientific and medical evaluation provided by HHS and all other data relevant to the abuse potential of DOI and DOC. These data as presented below demonstrate that DOI and DOC have a high potential for abuse.

a. There is evidence that individuals are taking the drug or other substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community.

Data show that DOI and DOC have been encountered by law enforcement in the United States (see Factor 5), indicating DOI and DOC availability for abuse. According to HHS, individuals are using DOI and DOC for their hallucinogenic effects and taking them in amounts sufficient to create a hazard to their health.

b. There is significant diversion of the drug or substance from legitimate drug channels.

HHS states that DOI and DOC are not Food and Drug Administration (FDA)-approved drugs for treatment in the United States and is unaware of any country in which their use is legal. DOI and DOC are available for purchase from legitimate chemical synthesis companies because they are used in scientific research. There is no evidence of diversion from these companies.

c. Individuals are taking the substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such substance.

DOI and DOC are not found in FDA-approved drug products and practitioners may neither legally prescribe nor dispense these substances. Therefore, individuals are taking DOI and DOC on their own initiative, rather than based on medical advice from practitioners licensed by law to administer drugs. This is consistent with the data from law enforcement seizures and case reports indicating that individuals are taking DOI and DOC on their own initiative rather than on the medical advice of licensed practitioners.

d. The drug is a new drug so related in its action to a drug or other substance already listed as having a potential for abuse to make it likely that the drug substance will have the same potential for abuse as such drugs, thus making it reasonable to assume that there may be significant diversion from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community.

Chemically, DOI and DOC are analogs of the schedule I hallucinogen DOM. The effects and pharmacological action of DOI and DOC are similar to those of other schedule I hallucinogens, such as DOM and lysergic acid diethylamide (LSD), which have no accepted medical use and a high abuse potential.

In drug discrimination studies (an in vivo test to assess drug abuse liability of test drugs in comparison to known drugs of abuse), DOI and DOC produce full substitution for the discriminative stimulus effects of DOM, LSD, and N,N -dimethyltryptamine (DMT, schedule I). In humans, anecdotal reports suggest that DOI and DOC produce classic hallucinogenic effects that are similar to DOM, including visual and auditory hallucinations, fatigue, headache, gastrointestinal distress, insomnia and anxiety. HHS notes that use of DOC in combination with other drugs is associated with emergency department admissions and one death.

Due to the psychological and cognitive disturbances associated with DOI and DOC, as with other schedule I hallucinogens, it is reasonable to assume that DOI and DOC have substantial capability to be a hazard to the health of the user and to the safety of the community.

In vitro testing shows that DOI and DOC bind to and act as agonists at serotonin (5-HT) 2A (5-HT 2A ) receptors. In rats, DOI administration induced an increase in wet dog shakes and back muscle contractions. These effects were attributed to 5-HT 2A receptor activation, since pretreatment with a 5-HT 2A receptor inverse agonist blocked the effect. Agonism of the 5-HT 2A receptor is the primary mechanism of action of typical hallucinogenic responses, suggesting that DOI and DOC have hallucinogenic effects. Additionally, animal testing data in rats show that DOI and DOC fully substitute for DOM, LSD, and DMT discriminative stimulus effects in drug discrimination tests.

In humans, HHS reported that anecdotal reports of hallucinogenic experiences with DOI and DOC are available on online drug forums such as www.erowid.org, in which recreational drug users report on their experiences with all classes of substances. In these reports, DOI and DOC are reported to induce hallucinogenic effects, including prominent visual effects.

Additionally, a World Health Organization (WHO) critical review of DOC  4 mentions its hallucinogenic effects reported by those that self-experimented with DOC and notes the duration of action may last 12 to 24 hours. WHO notes that the long duration of effects is shared by other structurally related schedule I hallucinogens including DOI, 2,5-dimethoxy-4-bromoamphetamine (DOB), and DOM. DOI and DOC are commonly administered orally and/or sublingually when encountered in the form of blotters.

DOI and DOC are centrally-acting hallucinogens and part of the phenethylamine hallucinogen family and share structural similarities with schedule I phenethylamine hallucinogens such as DOM. DOI (CAS 42203-78-1) has a molecular formula of C 11 H 16 INO 2 and a molecular weight of 321.16 g/mol. The hydrochloride salt of DOI has a melting point of 201 °C. DOC (CAS 123431-31-2) has a molecular formula of C 11 H 16 ClNO 2 and a molecular weight of 229.70 g/mol. The hydrochloride salt of DOC has a melting point of 193-194.5 °C. DOI and DOC are white, odorless, and crystalline solids.

The history and current pattern of abuse of DOI and DOC are described in law enforcement reports and anecdotal reports by drug abusers. In the United States, law enforcement entities initially encountered DOI and DOC in 2005, according to the National Forensic Laboratory Information System (NFLIS)-Drug  5 database. See Factor 5 for additional information. DOI and DOC are encountered in various forms ( e.g., powder, tablets, capsules, liquid, or on blotter paper).

Anecdotal reports on the internet indicate that individuals are using substances they identified as DOI and DOC for their hallucinogenic effects. Importantly, it is impossible to know if the street drugs sold to an individual as DOI or DOC are actually the substances they are marketed as in the absence of chemical analysis or evaluation of biological fluids following ingestion. However, in animal drug discrimination studies, DOI and DOC produced effects that are similar to the effects elicited by schedule I hallucinogens such as DOM, LSD, and DMT.

Regarding DOC, a July 2019 report from the European Monitoring Centre for Drugs and Drug Addiction included data from their toxicology portal, and indicated that 16 non-fatal intoxications associated with DOC had been reported internationally between 2008 and 2017. In 2019, the United Nations Office on Drugs and Crime reported three deaths associated with DOC (one each in 2015 and 2018; information about the third is unknown).

Data from NFLIS-Drug indicate that DOI and DOC were found in samples starting in 2005, in the United States. Specifically, there were 40 NFLIS-Drug reports for DOI from 2005 through December 2022, and 790 NFLIS-Drug reports for DOC during the same period. DOI has been encountered in 15 states, whereas DOC has been encountered in 39 states. In response to abuse and safety concerns, DOI has been controlled in Florida.

Abuse of DOI and DOC has been characterized as causing acute public health and safety issues worldwide. In particular, WHO reports that DOC has been available in Europe since 2001. Based on available abuse data, public health risk, and drug trafficking data, the WHO recommended to the United Nations (UN) that DOC be controlled internationally. In March 2020, the UN Commission on Narcotic Drugs voted to place DOC into Schedule I of the 1971 Convention.

DOI and DOC share similar mechanisms of action with and produce similar physiological and subjective effects (see Factor 2 for more information) as other schedule I hallucinogens, such as DOM, DMT, and LSD. Thus, DOI and DOC pose the same risks to public health as similar hallucinogens. Predominantly, the risks to public health are borne by users ( i.e., hallucinogenic effects, sensory distortion, impaired judgment, strange or dangerous behaviors), but they can affect the general public, as with driving under the influence. To date, there are no reports of distressing responses or death associated with DOI in medical literature. There have been three published reports, in 2008, 2014, and 2015, of adverse events associated with DOC including, but not limited to, seizures, agitation, tachycardia, hypertension, and death of one individual. Since DOI is structurally similar to DOC and produces similar effects to DOC, it is likely to produce serious adverse effects similar to DOC. Thus, serious adverse events that may include death represent a risk to the individual drug users and to public health.

According to HHS, the physiological dependence liability of DOI and DOC in animals and humans is not reported in scientific and medical literature. Thus, it is not possible to determine whether DOI and DOC produce physiological dependence following acute or chronic administration.

According to HHS, DOI, DOC, and other related phenethylamine hallucinogens (such as the schedule I substance DOM) are highly abusable substances. Drug discrimination studies in animals indicate that DOI and DOC fully substitute to the discriminative stimulus effects of schedule I hallucinogens DOM, LSD, and DMT. HHS notes that hallucinogens are not usually associated with physical dependence, likely due to the rapid development of tolerance precluding daily administration. Hallucinogen abusers may develop psychological dependence as evidenced by the continued use of these substances despite knowledge of their potential toxic and adverse effects.

DOI and DOC are not immediate precursors of any controlled substance of the CSA as defined by 21 U.S.C. 802(23).

Based on consideration of the scientific and medical evaluation and accompanying recommendation of HHS, and on DEA's own eight-factor analysis, DEA finds that these facts and all relevant data constitute substantial evidence of potential for abuse of DOI and DOC. As such, DEA proposes to schedule DOI and DOC as controlled substances under the CSA.

The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA also outlines the findings required to place a drug or other substance in any particular schedule, per 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the then-Assistant Secretary for Health of HHS to place DOI and DOC in schedule I and review of all other available data, the Administrator of DEA, pursuant to 21 U.S.C. 812(b)(1), finds that:

(1) DOI and DOC have a high potential for abuse that is comparable to other schedule I substances, such as the phenethylamine hallucinogen DOM;

(2) DOI and DOC have no currently accepted medical use in treatment in the United States. FDA has not approved a marketing application for a drug product containing DOI or DOC for any therapeutic indication, and DEA and HHS know of no clinical studies or petitioners claiming an accepted medical use in the United States. 6

(3) There is a lack of accepted safety for use of DOI and DOC under medical supervision. The use of DOC is associated with serious adverse consequences including deaths. Since DOI is structurally similar to DOC and produces effects similar to DOC, it is likely that DOI may produce serious adverse events similar to DOC. Because DOI and DOC have no approved medical use and have not been investigated as new drugs, their safety for use under medical supervision has not been determined.

Based on these findings, the Administrator of DEA concludes that DOI and DOC warrant control in schedule I of the CSA. More precisely, because of their hallucinogenic effects, and because they may produce hallucinogenic-like tolerance and dependence in humans, DEA proposes to place DOI and DOC, including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical description, in 21 CFR 1308.11(d) (the hallucinogenic substances category of schedule I).

If this rule is finalized as proposed, DOI and DOC would be subject to the CSA's schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distributing, dispensing, importing, exporting, research, and conduct of instructional activities, including the following:

1. Registration. Any person who handles (manufactures, distributes, dispenses, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses) would need to be registered with DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312.

2. Security. DOI and DOC would be subject to schedule I security requirements and would need to be handled and stored pursuant to 21 U.S.C. 821, 823, and in accordance with 21 CFR 1301.71-1301.76. Non-practitioners handling DOI and DOC also would need to comply with the screening requirements of 21 CFR 1301.90-1301.93.

3. Labeling and Packaging. All labels and packaging for commercial containers of DOI and DOC would need to comply with 21 U.S.C. 825, and be in accordance with 21 CFR part 1302.

4. Quota. Only registered manufacturers would be permitted to manufacture DOI and DOC in accordance with quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.

5. Inventory. Every DEA registrant who possesses any quantity of DOI and DOC would need to have an initial inventory of all stocks of controlled substances (including DOI and DOC) on hand on the date the registrant first engages in the handling of controlled substances, pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

After the initial inventory, every DEA registrant would need to take inventory of all controlled substances (including DOI and DOC) on hand every two years, pursuant to 21 U.S.C. 827, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

6. Records and Reports. Every DEA registrant would need to maintain records and submit reports for DOI and DOC, pursuant to 21 U.S.C. 827 and 832(a), and in accordance with 21 CFR 1301.74(b) and (c) and parts 1304, 1312, and 1317

7. Order Forms. Every DEA registrant who distributes DOI and DOC would need to comply with the order form requirements, pursuant to 21 U.S.C. 828 and 21 CFR part 1305.

8. Importation and Exportation. All importation and exportation of DOI and DOC would need to be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312.

9. Liability. Any activity involving DOI and DOC not authorized by, or in violation of, the CSA or its implementing regulations would be unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

In accordance with 21 U.S.C. 811(a), this proposed scheduling action is subject to formal rulemaking procedures performed “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures and criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed in E.O. 13563.

This proposed regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

This proposed rulemaking does not have federalism implications warranting the application of E.O. 13132. The proposed rule does not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.

This proposed rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

This proposed action does not impose a new collection of information requirement under the Paperwork Reduction Act, 44 U.S.C. 3501-3521.

The Administrator of DEA, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 601-612, has reviewed this proposed rule, and by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities.

DEA proposes placing the substances DOI and DOC (chemical names: 2,5-dimethoxy-4-iodoamphetamine [DOI] and 2,5-dimethoxy-4-chloroamphetamine [DOC]), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, in schedule I of the CSA. This action is being taken, in part, to enable the United States to meet its obligations under the 1971 Convention for DOC. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose to handle DOI and DOC.

According to HHS, and also by DEA's findings in this proposed rule, DOI and DOC have a high potential for abuse, have no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision. There appear to be no legitimate sources for DOI and DOC as marketed drugs in the United States, but DEA notes that these substances are available for purchase from legitimate suppliers for scientific research. There is no evidence of significant diversion of DOI and DOC from legitimate suppliers. As such, the proposed rule, if finalized, is not expected to result in a significant economic impact on a substantial number of small entities.

On the basis of information contained in the “Regulatory Flexibility Act” section above, DEA has determined pursuant to the Unfunded Mandates Reform Act (UMRA) of 1995 (2 U.S.C. 1501 et seq. ) that this proposed action would not result in 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 1 year * * *.” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.

This document of the Drug Enforcement Administration was signed on December 7, 2023, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

For the reasons set out above, 21 CFR part 1308 is proposed to be amended to read as follows:

Pursuant to the Outer Continental Shelf Lands Act (OCSLA) (43 U.S.C. 1350), BSEE has the delegated authority to assess civil penalties to certain entities engaged in oil and gas exploration, development, and production operations on the Outer Continental Shelf (OCS) following certain violations by those entities of a statutory provision, regulation, order, or lease term. The Department's implementing regulations for this authority are located at 30 CFR part 250, subpart N—Outer Continental Shelf Civil Penalties (§§ 250.1400-250.1409). Additional relevant regulations regarding the procedures for appealing civil penalty assessments are at 30 CFR part 290, subpart A-Bureau of Safety and Environmental Enforcement Appeal Procedures (§§ 290.1-290.8).

BSEE recently commenced a review of its civil penalty assessment appeal processes at 30 CFR part 250, subpart N and 30 CFR part 290, subpart A. BSEE's review was initiated following the IBLA's July 7, 2022, order in Petro Ventures, Inc. (IBLA No. 2020-48) analyzing the effect of the civil penalty appeal bonding requirements in 30 CFR 250.1409. This regulation, at paragraph (b), requires that an entity filing an appeal of a civil penalty assessment must either “[s]ubmit a surety bond in the amount of the penalty” or request that “your lease-specific/area-wide bond on file be used as the bond for the penalty amount.” When Interior proposed what is now 30 CFR 250.1409 in 1999, it explained that the civil penalty appeal bonding requirement was “designed to ensure that funds will be available to cover the final civil penalty assessment if the appeal is denied, and to discourage any appeals filed for the sole purpose of delaying payment of that assessment.” 64 FR 1930, 1966 (January 12, 1999). BSEE and its predecessors have consistently intended and understood this bonding requirement to operate as a condition precedent to an entity's right to pursue an appeal, and most entities pursuing civil penalty appeals have a similar understanding. The IBLA, however, concluded in Petro Ventures, Inc. that while 30 CFR 250.1409 requires that the appealing entity have bonding covering the appealed civil penalty amount, the regulation is not phrased in such a way as to make it a jurisdictional precondition or to support dismissal of the appeal if the bonding requirement is not met.

Accordingly, Interior is proposing revisions to 30 CFR 250.1409, What are my appeal rights?, and 30 CFR 290.4, How do I file an appeal?, to effectuate the original intent of the bonding requirement by ensuring that bonding is a jurisdictional precondition for maintaining an appeal of a BSEE civil penalty assessment at the IBLA.

BSEE proposes to change the introductory sentence of § 250.1409(b) from “If you file an appeal, you must either:” to “In order to file an appeal, you must perform one of the following actions within the 60-day appeal period to have your appeal heard:”. BSEE also proposes to move existing § 250.1409(d) to a new § 250.1409(e). The new proposed § 250.1409(d) would state: “Satisfying the bonding requirement in paragraph (b) of this section is a jurisdictional precondition for a civil penalty appeal. If you have timely filed a request with BOEM pursuant to paragraph (b)(2) of this section to use your lease-specific/area-wide bond on file as the bond for the penalty amount, the IBLA's jurisdiction over the appeal is preserved while BOEM's decision on your request is pending. Should BOEM deny your request or require additional security pursuant to paragraph (c) of this section, you have 30 days to satisfy paragraph (b)(1) of this section or post the required additional security, as applicable, and jurisdiction is preserved during that 30-day period. If you fail to satisfy these bonding requirements, the IBLA will lose jurisdiction and must dismiss your appeal.” Together, these proposed provisions would effectuate the intended functions of BSEE's bonding requirements for filing and maintaining a civil penalty appeal at the IBLA. BSEE requires bonding covering the civil penalty amount for all civil penalty appeals to ensure that funds will be available to cover the civil penalty amount if the assessment is upheld and to discourage appeals filed for the sole purpose of delaying payment of that assessment.

Lastly, BSEE proposes to modify the existing § 250.1409(d), which would become the new § 250.1409(e), by changing the introductory sentence from “If you do not either pay the penalty or file a timely appeal, BSEE will take one or more of the following actions:” to “If you do not either pay the penalty or fully satisfy the appeal requirements, the Department may take one or more of the following actions:”. In paragraph (e)(1), BSEE proposes to delete “We will” and start the sentence with “Collect.” In paragraph (e)(2), BSEE proposes to delete “We may” and start the sentence with “Initiate.” In paragraph (e)(3), BSEE proposes to delete “We may” and start the sentence with “Bar.” BSEE proposes these edits because different entities within Interior may take the listed actions and to improve the grammatical structure of the overall provision.

BSEE proposes to add a new paragraph (c) to § 290.4. Existing § 290.4 sets forth the items that BSEE must receive within 60 days after a party receives the appealed decision for the appeal to be considered properly filed. The proposed paragraph (c) would add to that list: “If you are appealing a civil penalty assessment, either notification of payment of the penalty or documentation demonstrating satisfaction of the requirements in 30 CFR 250.1409(b).” As with the other appeal filing requirements in the section, it would also expressly state that the appellant “cannot extend the 60-day period for satisfying this requirement, except as specifically provided in 30 CFR 250.1409(d).” BSEE is proposing these additions to ensure awareness of, and consistency with, the requirements in the proposed § 250.1409; to ensure that appealing entities timely provide BSEE with documentation demonstrating compliance with § 250.1409; and to further emphasize the nature of the bonding requirement as a jurisdictional precondition to maintenance of an appeal.

When an agency issues a rulemaking proposal, the Regulatory Flexibility Act (RFA) requires the agency to “prepare and make available for public comment an initial regulatory flexibility analysis” that will “describe the impact of the proposed rule on small entities.” (5 U.S.C. 603(a)). Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the proposed rulemaking is not expected to have a significant economic impact on a substantial number of small entities.

BSEE estimates that at least 80 entities (lessees, grant holders, and operators) would be subject to this proposed rule, of which approximately 60 percent are small according to the U.S. Small Business Administration size standards based on each firm's North American Industry Classification System code, number of employees, and annual revenues. Therefore, BSEE has determined that this proposed rule would apply to a substantial number of small entities.

However, BSEE has determined that the impact on entities affected by the proposed rule would not be significant. The provisions would only align the language of the regulations with BSEE's and the regulated industry's longstanding understanding of the effects of the existing requirement. Existing regulations have long required satisfaction of appeal bonding requirements for appeals of civil penalty assessments, and the proposed revisions would only clarify the procedural effects of noncompliance with that requirement. They would not add any cost burdens to entities that would be subject to the proposed rule. Accordingly, the Department hereby certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities. BSEE invites comments from members of the public who believe there would be a significant impact on companies subject to the proposed rule.

The Congressional Review Act (CRA) defines a rule as major if it meets any of three criteria. The three criteria are:

A. Does the rule have an annual effect on the economy of $100 million or more?

B. Will the rule cause a major increase in the cost or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions?

C. Does the rule have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises?

This proposed rule is not a major rule under the CRA. This rule would neither generate an annual economic effect of $100 million or more; nor cause major price increases for consumers, businesses, or governments, or geographic regions; nor degrade competition, employment, investment, productivity, innovation, or the ability of U.S. businesses to compete against foreign businesses. Its effects would be purely administrative, legal, and procedural.

This proposed rule would not impose an unfunded mandate on state, local, or Tribal governments or the private sector of more than $189 million per year. The proposed rule would not have a significant or unique effect on State, local, or Tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act is not required.

This proposed rule does not contain information collection requirements, and a submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act is not required. We may not conduct or sponsor, and you are not required to respond to, a collection of information unless it displays a currently valid OMB control number.

This proposed rule would not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the National Environmental Policy Act of 1969 (NEPA) is not required because, as a regulation of an administrative, legal, and procedural nature, this proposed rule is covered by a categorical exclusion ( see 43 CFR 46.210(i)). BSEE also determined that the proposed rule would not implicate any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA. Therefore, a detailed statement under NEPA is not required.

E.O. 12866, Regulatory Planning and Review, as amended by E.O. 14094, provides that OMB's Office of Information and Regulatory Affairs (OIRA) will review all significant regulatory actions. A significant regulatory action is one that is likely to result in a rule that:

A. Has an annual effect on the economy of $200 million or more (adjusted every 3 years by the Administrator of OIRA for changes in gross domestic product); or adversely affects 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;

B. Creates a serious inconsistency or otherwise interferes with an action taken or planned by another agency;

C. Materially alters the budgetary impacts of entitlements, grants, user fees, loan programs, or the rights and obligations of recipients thereof; or

D. Raises legal or policy issues for which centralized review would meaningfully further the President's priorities or the principles set forth in E.O. 12866.

OIRA has concluded that this proposed rule is not a significant action under E.O. 12866. The provisions would only align the language of the regulations with BSEE's and the regulated industry's longstanding understanding of the effects of the existing requirements and would not add any cost burdens to entities that would be subject to the proposed rule, yielding only procedural effects. Accordingly, BSEE does not anticipate that this proposed rule would have an annual economic impact of $200 million or more or would have a material adverse effect on the economy, a sector of the economy, productivity, competition, jobs, public health or safety, the environment, or State, local, or Tribal governments or communities. This proposed rule also would not raise novel legal or policy issues.

E.O. 13563, Improving Regulation and Regulatory Review, reaffirms the principles of E.O. 12866 while calling for improvements in the Nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. E.O. 13563 directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 further emphasizes that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this proposed rule in a manner consistent with these requirements.

Under the criteria in E.O. 12630, this proposed rule does not have significant takings implications. The proposed rule is not a governmental action capable of interference with constitutionally protected property rights. A Takings Implication Assessment is not required.

Under the criteria in E.O. 13132, this proposed rule does not have federalism implications. This proposed rule would not substantially and directly affect the relationship between the Federal and State governments. To the extent that State and local governments have a role in OCS activities, this proposed rule would not affect that role. A federalism assessment is not required.

This proposed rule complies with the requirements of E.O. 12988. Specifically, this proposed rule:

A. Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and

B. Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.

BSEE strives to strengthen its government-to-government relationships with Tribal Nations and Alaska Natives through a commitment to consultation with Tribes and recognition of their right to self-governance and Tribal sovereignty. We are also respectful of our responsibilities for consultation with Alaska Native Claims Settlement Act Corporations. BSEE has reviewed this proposed rule pursuant to the criteria in E.O. 13175, Consultation and Coordination with Indian Tribal Governments (dated November 6, 2000), Interior's Policy on Consultation with Indian Tribes and Policy on Consultation with Alaska Native Claims Settlement Act Corporations (512 Departmental Manual 4, dated November 30, 2022, and 512 Departmental Manual 6, dated November 30, 2022, respectively), and Interior's Procedures for Consultation with Indian Tribes and Procedures for Consultation with Alaska Native Claims Settlement Act Corporations (512 Departmental Manual 5, dated November 30, 2022, and 512 Departmental Manual 7, dated November 30, 2022, respectively) and has determined that this rule would not have substantial direct effects on Tribal Nations or Alaska Natives, on the relationship between the Federal government and Tribal Nations or Alaska Natives, or on the distribution of power and responsibilities between the federal government and Tribal Nations or Alaska Natives.

This proposed rule is not a significant energy action under the definition in E.O. 13211. This proposed rule is not likely to have a significant adverse effect on the supply, distribution, or use of energy. A Statement of Energy Effects is not required.

E.O. 12898 requires Federal agencies to make achieving environmental justice part of their mission by identifying and addressing disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority and low-income populations. BSEE has determined that this proposed rule would not have a disproportionately high or adverse human health or environmental effect on native, minority, or low-income communities because its provisions are administrative and procedural in nature and do not affect public safety, environmental protection, or OCS operational requirements.

We are required by E.O. 12866, E.O. 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:

A. Be logically organized;

B. Use the active voice to address readers directly;

C. Use clear language rather than jargon;

D. Be divided into short sections and sentences; and

E. Use lists and tables whenever possible.

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

For the reasons stated in the preamble, the Department of the Interior is proposing to revise 30 CFR parts 250 and 290 as follows:

The revisions and additions read as follows:

The revisions and additions read as follows:

The NISPOM establishes requirements for the protection of classified information disclosed to or developed by contractors, licensees, grantees, or certificate holders to prevent unauthorized disclosure. The National Industrial Security Program (NISP) is established by Executive Order (E.O.) 12829 “National Industrial Security Program (NISP)” (available at https://www.archives.gov/files/isoo/policy-documents/eo-12829-with-eo-13691-amendments.pdf ) provides a single integrated, cohesive industrial security program to protect classified information to preserve our Nation's economic and technological interests. Under the NISP, the USG establishes requirements for the protection of classified information to be safeguarded in a manner equivalent to its protection within the executive branch of USG, where practicable. For industry, those requirements are included in the NISPOM. When bound by contract, license, or grant, industry must comply with the NISPOM and any Cognizant Security Agency (CSA)-specific supplementary guidance for unique CSA mission requirements. As the Executive Agent of the NISP, the Secretary of Defense is responsible for overall implementation of the program. The Department of Defense (DoD) issues and maintains the NISPOM with the concurrence of the other four NISP CSAs and in consultation with other affected Federal agencies.

DoD codified the NISPOM in a final rule on December 21, 2020 (85 FR 83300-83364) National Industrial Security Program Operating Manual (NISPOM) to add 32 CFR part 117 to the Code of Federal Regulations (CFR). The rule was effective on February 24, 2021. In addition to adding the NISPOM to the CFR, the final rule incorporated requirements of Security Executive Agent Directive (SEAD) 3, Reporting Requirements for Personnel with Access to Classified Information or Who Hold a Sensitive Position. SEAD 3 requires reporting by all contractor cleared personnel who have been granted eligibility for access to classified information. The final rule provided a single nation-wide implementation plan to include SEAD 3 reporting by all contractor cleared personnel to report specific activities that may adversely impact their continued national security eligibility, such as reporting of foreign travel and foreign contacts. NISP CSAs are required to conduct an analysis of such reported activities to determine whether they pose a potential threat to national security and take appropriate action. Finally, the rule also implemented the provisions of Section 842 of Public Law 155-232, which removed the requirement for a covered National Technology and Industrial Base (NTIB) entity operating under a special security agreement pursuant to the NISP to obtain a national interest determination as a condition for access to proscribed information. The 60-day public comment period ended on February 19, 2021.

On August 19, 2021, DoD published a technical amendment to the December final rule (at 86 FR 46597-46599) to extend until August 24, 2022, the implementation date for those contractors under DoD security cognizance to report and obtain pre-approval of unofficial foreign travel to the DoD. The technical amendment was effective on August 19, 2021 and was done to allow DoD to make modifications to its information technology (IT) systems. The technical amendment addressed comments from regulated parties on the burdensome nature of submitting individual foreign travel reports for those contractors under DoD security cognizance. The technical amendment allowed DoD more time to make the necessary changes to the IT system for multiple foreign travel reports in a single submission.

This proposed rule addresses the comments received on the final rule published in December 2020 and further amends the 32 CFR 117 to make the following changes as discussed below.

The December 21, 2020 final rule received nine sets of public comments from five individuals who provided 11 comments, two companies that provided 41 comments, an industry representative organization that provided 28 comments, and a law firm that provided four comments, for a total of 84 comments.

The vast majority of the comments related to a request for clarification on procedures for those contractors under DoD security cognizance. Many of the comments did not result in a change to the rule because they related to procedures that a NISP CSA would provide to supplement unique CSA mission requirements. For contractors under DoD security cognizance, DoD provides unique CSA mission guidance via industrial security letters (ISLs) when applicable. ISLs are published on the Defense Counterintelligence and Security Agency (DCSA) website ( https://www.dcsa.mil/ ) and will address the comments received and re-issue previous NISPOM ISLs, as needed. Previous ISLs were tied to the content of the NISPOM when it was a DoD manual. Some of the guidance contained in prior ISLs has been incorporated into the rule and is no longer needed. Those ISLs that are still needed in order to provide further guidance to those contractors under DoD security cognizance will be re-issued in accordance with the rule.

Many comments were received on § 117.8, relating to implementation of SEAD 3, Reporting Requirements for Personnel with Access to Classified Information or Who Hold a Sensitive Position, published by the Office of the Director of National Intelligence. Commenters were concerned with the lack of guidance on how information systems will be used to report foreign travel and when foreign travel reporting should be accomplished by contractors. Also, commenters requested more details as to who approves foreign travel requests: the contractor security staff, the government customer, or CSA. DoD also received comments from regulated parties stating it would be burdensome for contractors under DoD security cognizance to submit individual foreign travel reports. Regulated parties recommended DoD modify its information technology (IT) system so a contractor may submit multiple or batched foreign travel reports in a single submission. As discussed earlier, to allow time for the completion of modifications to DoD's IT system, DoD published an amendment on August 19, 2021, to extend until August 24, 2022, the implementation date for contractors under DoD security cognizance to report and obtain pre-approval of unofficial foreign travel to DoD. The IT system was modified prior to the August 2022 implementation date and can now receive multiple foreign travel reports at a time.

Additionally, one commenter opined the cost to contractors to implement SEAD 3 was underestimated—both in the time it will take to report and the number of reports that will be generated. We agree with this assessment and the corrected numbers can be found in the cost analysis section of the preamble. Further, commenters asked how the CSA will analyze the reported data and if the analysis will be shared with the contractor or the cleared employee going on foreign travel. For those contractors under DoD cognizance, guidance was provided via an ISL ( https://www.dcsa.mil/Portals/128/Documents/CTP/tools/ISL2021-02_SEAD-3.pdf ) to provide supplementary procedures and inform industry how compliance with SEAD 3 will be accomplished for unique DoD mission needs.

DoD received seven comments on CUI as it relates to the paragraphs on security reviews (§ 117.7), training (§ 117.12), and safeguarding CUI (§ 117.15). DoD did not make any changes to the rule as compliance with CUI is outside the scope of the NISP. For the purposes of this rule, if a contractor has a classified contract that also includes provisions for CUI, then, under certain circumstances, CUI assessments may be conducted by the CSA in conjunction with NISP USG reviews. The contractor must follow the requirements as stated in their contract concerning the safeguarding of CUI.

DoD received several comments on § 117.7, to include that a facility security officer (FSO) should be a U.S. citizen with no exceptions; and the text was updated accordingly in 117.7(b). The text clarifies that the only exception for U.S. citizenship may apply to the Senior Management Official or Insider Threat Program Senior Official if the entity has a limited entity eligibility determination due to foreign ownership, control, or influence. Two commenters observed that § 117.7(h)(1)(i) did not include the frequency of security review cycles. DoD is accepting this change and has modified § 117.7(h)(1)(i) to reflect security reviews will only occur once every 12 months unless special circumstances exist, to include addressing security vulnerabilities found during a previous security review. Another commenter expressed concern the final rule allowed a CSA to conduct unannounced reviews at its discretion without any specific guidelines. Based on this comment, DoD has proposed to update § 117.7(h)(1)(ii)(A) to clarify unannounced security reviews will be conducted only if there is a possibility of the imminent loss or compromise of classified information.

DoD received several comments on eligibility determinations in § 117.10, to include a request for clarification on the system of record for personnel security clearances, clarification of requirements for current investigations, reinvestigation, and continuous evaluation requirements, definition of what is considered a break in access and break in employment, and the process for requesting and granting an extension if a temporary eligibility determination goes beyond a year. DoD is not proposing any changes based on these comments as clarification to contractors under DoD cognizance will be provided when applicable via ISLs.

DoD received comments on the changes to the NID requirements for a covered National Technology and Industrial Base (NTIB) entity based on section 842 of Public Law 115-232 included in § 117.11. Commenters asked for clarification on which specific entities fall under section 842 of Public Law 115-232 and recommended that NIDs be eliminated completely. The final NISPOM rule reflects language taken directly from section 842 of Public Law 115-232, which includes eliminating a NID requirement for U.S.-cleared companies owned by Australia, Canada, and the United Kingdom. DoD is not making any changes based on these comments as DoD is unable to eliminate NIDs, since the provisions for NID requirements are driven by 32 CFR part 2004, National Industrial Security Program, and not this rule. There has been no change to the NID requirements in 32 CFR part 2004 outside of section 842 Public Law 115-232.

Eight comments were received on safeguarding, § 117.15, to include four on open storage areas and another four on intrusion detection systems (IDS). Commenters also requested more guidance on open storage area requirements included in the previous NISPOM DoD Manual, to include procedures for leaving an open storage area unattended during business hours, whether self-approval authority can still be delegated to FSOs by a CSA, procedures to ensure the structural integrity of the space, and whether open bin and open shelf storage is still permitted. DoD is proposing updated text in § 117.15(a) and (c) to address several of these comments ( e.g., procedures for leaving an open storage area unattended during business hours and delegation of approval authority to FSOs if agreed to by the CSA, respectively) and as a result added a definition for “pedestrian door locks” from the added text on security checks. DoD is also proposing updated text in paragraph 117.15(d) to provide more clarity on required investigative response to alarms for IDS. More guidance on safeguarding for those contractors under DoD cognizance will be provided via forthcoming ISLs, as appropriate. DoD is also proposing additional text to § 117.15(e) regarding information management systems to more accurately reflect the terminology for classified information systems, and as a result added the term “authorization to operate” to the definitions section in § 117.3. Finally, DoD is proposing additional text to § 117.15(e)(6) to provide more clarity on the requirements for the reproduction of classified information, to include accountability, control, and marking requirements of the reproduced classified information, and procedures for waste products resulting from the reproduction.

A commenter questioned the accuracy of the text in § 117.17(a)(3) which stated that if an entity eligibility determination could not be completed in time to qualify the prospective subcontractor for participation in a procurement action, that the CSA will continue the entity eligibility determination processing for future contract consideration. After review of this text, DoD has concluded this text provides guidance to CSAs, rather than contractors and is proposing it for deletion.

Finally, the reference to the Joint Personnel Adjudication System is proposed for deletion from the list of approved information collections as part of the Paperwork Reduction Act section because it has been discontinued and replaced by the Defense Information System for Security. The text in § 117.5(d) has also been proposed for updating to reflect only the Defense Information System for Security is used for the initiation, investigation, and adjudication of information relevant to DoD security clearances and employment suitability determinations.

The proposed rule changes seek to provide clarification on safeguarding terminology and correct identified paragraph numbering errors, as well as address comments from regulated parties seeking more detail or guidance on existing requirements from the final rule published December 21, 2020. The proposed changes are mostly insignificant in that by themselves, these proposed changes create no additional requirements to current NISP policy. For example, a paragraph on subcontracting was removed because it was deemed to be guidance for the government, rather than contractors ( i.e., the regulated parties). Also, the references to the Joint Personnel Adjudication System as the system of record for personnel security clearance processing were removed and replaced with the current system of record, Defense Information System for Security. These changes create no additional burden or cost to contractors; but rather seek to provide updated, accurate information. The proposed changes also seek to clarify terminology in relation to safeguarding requirements, which were initially incorporated into the final rule published December 21, 2020 to be in line with 32 CFR part 2001. These changes are not expected to result in any changes to cost estimates or burden on the regulated parties, but rather provide a more consistent, uniform means to comply with existing NISP requirements across the federal government.

As stated under the Discussion of Comments and Changes section, DoD received one comment that the cost for implementing SEAD 3 was underestimated in the original rule. DoD agrees with the commenter and the cost estimates have been updated accordingly.

We are including here the summary of information on the baseline cost from the original rule for reference. DCSA began the cost analysis for the baseline costs for fiscal year 2017 by randomly selecting active NISP contractor facilities that have existing DoD approval for classified storage at their own physical locations and having those facilities submit security costs. The randomly selected contractor facilities also have an active facility security clearance and a permanent Commercial and Government Entity (CAGE) Code. In addition to the randomly selected cleared facilities having approved classified storage, DCSA categorizes these contractor facilities for the survey based on the size, scope, and complexity of each contractor's security program.

The general methodology used to estimate security costs incurred by contractor cleared facilities with approved storage of classified information is based on the costs incurred by respondent contractors for the protection of classified information. The methodology captures the most significant portion of industry's costs, which is labor. Security labor in the survey is defined as personnel whose positions exist to support operations and staff in the implementation of government security requirements for the protection of classified information. Guards who are required as supplemental controls are included in security labor. The respondent contractors are requested to compile their cleared facility's current annual security labor cost in burdened, current year dollars with the most recent data being from the 2017 survey. The labor cost, when identified as an estimated percent of each contractor's total security costs, enables the respondent contractors to calculate their total security costs.

Information collected is compiled to create an aggregate estimated cost of NISP classification-related activities. Only the aggregate data is reported. The full enterprise industrial security total baseline cost in the December 21, 2020, rule was estimated to not exceed $1.486 billion for fiscal year 2017. Based on the data collected from the survey, we can be 95% confident the true 2017 total NISP security cost for contractor facilities with approved classified storage is less than $1.486 billion.

1. Cost Analysis. Throughout, labor rates are adjusted upward by 100% to account for overhead and benefits. The following areas, 1.a and 1.b, were re-evaluated for cost based on the public comment.

a. Train all cleared employees on requirements to submit foreign travel reports. We determined that the estimate of cleared contractor personnel who would be required to be trained should also include TOP SECRET cleared employees rather than just SECRET cleared employees as indicated in the original rule. The FSO at each entity (small or large) must ensure that its cleared employees are trained on the requirements. Such training by the FSO is estimated to take one hour in 2021 and a half an hour in each of the following years up to the 20th year. Using the published Office of Personnel Management GS salary schedule for FY20, the estimated labor rate for an FSO of a small business entity firm is the equivalent of a GS11 step 5 and for an FSO of a large business entity is the equivalent of a GS13, step 5. These assumptions imply total costs of $0.99 million in 2021 as year one; and, $0.49 million each year from year two through the 20th year. These estimates have not changed from the original baseline.

b. We determined that the estimate of cleared contractor personnel who would be required to submit foreign travel reports should also include TOP SECRET cleared employees rather than just SECRET cleared employees as indicated in the original rule. As a result, the estimated cost has increased from $16.81 to $19.25 million. The following provides details on the estimated increase. All cleared employees, rather than only SECRET cleared employees, must submit foreign travel reports, and receive any pre-travel threat briefings or post travel briefings from the FSO based on the threat according to this rule, SEAD 3, and CSA-provided guidance for unique mission requirements. It is estimated that the number of foreign travel reports submitted annually will increase from 483,681 as estimated in the original rule to 813,054 to comply with the amendment. That estimate is based on analysis of calendar year 2019 unofficial foreign travel reported by DoD civilians and military in the DoD Aircraft and Personnel Automated Clearance System (APACS), a web-based tool for the creation, submission, and approval of aircraft diplomatic clearances and personnel travel clearances ( i.e., Country, Theater, and Special Area, as applicable with individual DoD Foreign Clearance Guide (FCG), https://www.fcg.pentagon.mil country pages) designed to aid USG travelers on official government and unofficial ( e.g., leave) travel. For calendar year 2019, there were 126,131 travelers and 113,214 travel requests submitted into APACS. APACS requirements are published on the DoD FCG, https://www.fcg.pentagon.mil. Thus, an annual estimate of .89 expected foreign travel trips by traveler (113,214 divided by 126,131). In the small business analysis, there was a total of 18,242 cleared employees in the 658 small entities sampled and 63,598 cleared employees in the remaining 356 non-small businesses. Of the total cleared employees in the small business analysis (as reported in the National Industrial Security System), approximately 22.3% were at small entities, and 77.7% were at non-small businesses. Known number of new travelers expected to be affected by this proposed rule will increase from the initial estimate of 543,462 to 905,818 cleared contractor personnel, an increase of 362,356 to include TOP SECRET cleared contractor personnel under DoD security cognizance and the estimated trips at .89 per traveler is (905,818 × .89 = 813,054 estimated trips). Assuming the ratio for those employees reporting foreign travel into APACS is the same as cleared employees would report, of the estimated 813,054 foreign trips by cleared employees, it can be estimated that approximately 181,262 (22.3% of 813,054) will be taken by contractors at small entities, and 631,792 (77.7% of 813,054) by contractors at non-small businesses. It is estimated that it will take a half an hour for a cleared employee to report foreign travel in 2021 and in each of the following years up to year 20 to report foreign travel and receive any pre-travel or post-travel briefings. The estimated average labor rate for a cleared employee to report foreign travel is the equivalent of a GS11 step 5. These assumptions imply costs increasing from $16.81 to $19.25 million in each year one through 20.

2. Projected Public Costs. Based on the re-evaluation of the cost of training cleared employees on foreign travel reporting and submissions, the estimated public costs are present value costs of $267.4 million, which includes the additional foreign travel reporting cost.

3. Updated Baseline Cost. With this increase for the foreign travel reporting, DoD's updated enterprise industrial security baseline cost is estimated not to exceed $1.753 billion ($1.486 billion plus $267.4 million).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. It has been determined that this rule is a significant regulatory action. Accordingly, the rule has been reviewed by the Office of Management and Budget (OMB) under the requirements of these Executive Orders.

This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

The Under Secretary of Defense for Intelligence and Security, pursuant to a delegation of authority from the Secretary of Defense, certifies that this rule will not, if promulgated, have a significant economic impact on a substantial number of small business entities in accordance with the Regulatory Flexibility Act (5 U.S.C. 601) requirements since a contractor cleared legal entity may, in entering into contracts requiring access to classified information, negotiate for security costs determined to be properly chargeable by a Government Contracting Activity.

Notwithstanding any other provision of law, no person is required to respond to, nor is subject to a penalty for failure to comply with, a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This proposed rule involves collections previously approved by OMB under the following control numbers.

DoD believes the total burden hours associated with these collections are not expected to change based on the amendments proposed in this rule. Information on the current version of these collections, including all supporting materials, can be obtained at https://www.reginfo.gov/public/do/PRAMain and typing in the OMB control number.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1532) requires agencies to assess anticipated costs and benefits before issuing any rule whose mandates require spending in any one year of $100 million in 1995 dollars, updated annually for inflation. This rule will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.

E.O. 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This rule will not have a substantial effect on State and local governments.

Executive Order 13175 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct compliance costs on one or more Indian tribes, preempts tribal law, or affects the distribution of power and responsibilities between the federal government and Indian tribes. This rule will not have a substantial effect on Indian tribal governments.

Accordingly, the Department of Defense proposes to amend 32 CFR part 117 as follows:

The revisions read as follows:

The revision reads as follows:

The revision reads as follows:

The revisions and additions read as follows:

The revisions read as follows:

The Captain of the Port Sector Ohio Valley (COTP) proposes to update the current list of recurring special local regulations for events occurring within the Sector Ohio Valley area of responsibility within the Coast Guard's Eighth District. The list of events we seek to update is in Title 33 of the Code of Federal Regulations (CFR) section 100.801, Table 1 to § 100.801.

The Coast Guard will consider comments submitted on this proposed rule in determining if any additional revisions are needed to this regulatory section. Additionally, the public would be informed of these recurring events through local means and planned by the local communities.

The current list of annual and recurring special local regulations occurring in Sector Ohio Valley's AOR is published in 33 CFR 100.801, Table 1 titled “Ohio Valley Annual and Reoccurring Marine Events.” The most recent list was published on April 4, 2023 (87 FR 6026).

The Coast Guard's authority for establishing a special local regulation is contained in 46 U.S.C. 70041(a). The Coast Guard proposes to amend and update the special local regulations in 33 CFR 100.801, Table 1, to include the most up to date list of recurring special local regulations for events held on or around the navigable waters within Sector Ohio Valley's AOR. These events would include marine parades, boat races, swim events, and other marine related events. The current list under 33 CFR 100.801, Table 1, requires amendment to provide new information on existing special local regulations, add new special local regulations expected to recur annually or biannually, and to remove special local regulations that no longer occur. Issuing individual regulations for each new special local regulation, amendment, or removal of an existing special local regulation creates unnecessary administrative costs and burdens. This single proposed rulemaking will considerably reduce administrative overhead. It also provide the public with notice through publication in the Federal Register of all recurring special local regulations in the AOR.

Part 100 of 33 CFR contains regulations describing regattas and marine parades conducted on U.S. navigable waters in order to ensure the safety of life in the regulated areas. Section 100.801 provides the regulations applicable to events taking place in the Eighth Coast Guard District and also provides a table listing each event and special local regulations. This section requires amendment from time to time to properly reflect the recurring special local regulations. This proposed rule would update section 100.801, Table 1 titled “Ohio Valley Annual and Reoccurring Marine Events.”

This proposed rule would add 4 new recurring special local regulations to Table 1 of section 100.801 for Sector Ohio Valley, as follows:

These new recurring special local regulations would be reflected in the table in the general date order in which they will occur. The current recurring special local regulations would be reordered, as shown in the proposed regulatory text below.

Additionally, this proposed rule would amend 27 recurring special local regulations in Table 1 of section 100.801 for Sector Ohio Valley, as follows. The revisions provide more accurate descriptions of the events, dates, locations, and areas.

The Saginaw River is a 22.4-mile-long river in that is a popular recreational and an important shipping route for mid-Michigan and the Great Lakes in general. The Independence Bridge, mile 3.88, is one of sixteen bridges that cross the Saginaw River in the Bay City Metropolitan Area. Out of the sixteen bridges only four are bascule bridges, two are owned by the State of Michigan and two have been recently leased by the city of Bay City to United Bridge Partners, a private company that intends to rehabilitate the two bridges and charge vehicles tolls to cross the bridges.

The proposal to lease the bridges and charge tolls has created the need for several public meetings and has flooded the local area news media with stories concerning the progress of the rehabilitation and administration regarding the Independence Bridge.

United Bridge Partners has established a physical customer service office within Bay City and a twenty-four-hour call line residents and mariners can call to receive information concerning the bridge operations and proposed construction schedule. United Bridge Partner, the City of Bay City, along with their chosen contractor held a public meeting on August 15, 2023, along with many media interviews prior to the public meeting. Most of the questions from the public were regarding the pass ability of vehicles and tolls associated with the new bridge ownership rather than the impacts the maintenance would have on the marine community.

On November 13, 2023, representatives from Congressman Dan Kildee, Senator Gary Peters, Congressman John Moolenaar, and Senator Debbie Stabenow's offices along with the U.S. Coast Guard and nineteen area stakeholders had a meeting to discuss the proposed rehabilitation project's effects on vessel traffic. The thirty people in attendance proposed the conditions in this proposed rule.

The Independence Bridge, mile 3.88, is a double leaf bascule bridge that crosses the Saginaw River and provides a horizontal clearance of 150 feet and a vertical clearance of 22 feet above LWD in the closed position and an unlimited clearance in the open position. The bridge allows vehicles and pedestrians to cross the river near the north end of the City of Bay City. The Independence Bridge, mile 3.88, is regulated under 33 CFR 117.647 and is allowed to open twice hourly in the summer and from January 1 through March 31 will open if a 12-hour advance notice is provided.

The reason for this proposed rule will be to allow the bridge to be secured to masted navigation from December 1 through March 31 and then through the summer require a 2-hour advance notice for openings to accommodate the rehabilitation of the bridge.

Granit Construction, the official contractor for the bridge owner has made this request for a temporary change in the bridge schedule to allow for the rehabilitation of structural, electrical, and mechanical components of the bridge during the winter when accumulation of ice makes navigating the river difficult.

The Independence Bridge, mile 3.88, is near the mouth of the river and there are no alternative routes for vessels. The December 1 to March 31 dates have been identified by local stake holders and dock owners as the best time to secure the bridge to masted navigation for the rehabilitation project. Because the new bridge owner intends to charge tolls on the bridge that once was free to cross has caused several people to be concerned about any bridge project in the area.

We developed this proposed rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on these statutes and Executive orders.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This proposed rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the ability that vessels can still transit the bridge given advanced notice and that the repair winter work will be done at a time of year when vessel traffic is at its lowest.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.

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

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this proposed rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this proposed rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the proposed rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

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

Also, this proposed rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments) because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

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

We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01, Rev.1, associated implementing instructions, and Environmental Planning Policy COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). The Coast Guard has determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule promulgates the operating regulations or procedures for drawbridges. Normally such actions are categorically excluded from further review, under paragraph L49, of chapter 3, table 3-1 of the U.S. Coast Guard Environmental Planning Implementation Procedures.

Neither a Record of Environmental Consideration nor a Memorandum for the Record are required for this proposed rule. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

We view public participation as essential to effective rulemaking and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

Submitting comments. We encourage you to submit comments through the Federal Decision-Making Portal at https://www.regulations.gov. To do so, go to https://www.regulations.gov, type USCG-2023-0912 in the search box and click “Search.” Next, look for this document in the Search Results column, and click on it. Then click on the Comment option. If your material cannot be submitted using https://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

Viewing material in docket. To view documents mentioned in this proposed rule as being available in the docket, find the docket as described in the previous paragraph, and then select “Supporting & Related Material” in the Document Type column. Public comments will also be placed in our online docket and can be viewed by following instructions on the https://www.regulations.gov Frequently Asked Questions web page. Also, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted, or a final rule is published of any posting or updates to the docket.

We review all comments received, but we will only post comments that address the topic of the proposed rule. We may choose not to post off-topic, inappropriate, or duplicate comments that we receive.

Personal information. We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have provided. For more about privacy and submissions in response to this document, see DHS's eRulemaking System of Records notice (85 FR 14226, March 11, 2020).

For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows:

In accordance with the Clean Air Act (CAA or Act), EPA is proposing to approve the Birmingham Area LMP for the 2006 24-hour PM 2.5 NAAQS, adopted by ADEM on February 2, 2021, and submitted by ADEM as a revision to the Alabama SIP under a cover letter with the same date. 1 The Birmingham Area LMP is designed to maintain the 2006 24-hour PM 2.5 NAAQS within the Birmingham Area through the end of the second 10-year portion of the maintenance period beyond redesignation. EPA is proposing to approve the plan because it meets all applicable requirements under CAA sections 110 and 175A. As a general matter, the Birmingham Area LMP relies on the same control measures and similar contingency measures to maintain the 2006 24-hour PM 2.5 NAAQS during the second 10-year portion of the maintenance period as the maintenance plan submitted by ADEM for the first 10-year period, which is not a limited maintenance plan.

Fine particulate matter, particulate matter with an aerodynamic diameter of 2.5 microns or less, can be emitted directly into the atmosphere as a solid or liquid particle (“primary PM 2.5 ” or “direct PM 2.5 ”) or can be formed in the atmosphere as a result of various chemical reactions among precursor pollutants such as nitrogen oxides (NO X ), sulfur oxides, volatile organic compounds (VOC), and ammonia (NH 3 ) (“secondary PM 2.5 ”). 2 Epidemiological studies have shown statistically significant correlations between elevated levels of PM 2.5 and premature mortality. Other important health effects associated with PM 2.5 exposure include aggravation of respiratory and cardiovascular disease, changes in lung function, and increased respiratory complications, contributing to premature mortality and increased hospital admissions and emergency room visits. Individuals particularly sensitive to PM 2.5 exposure include older adults, people with heart and lung disease, and children. 3

On July 18, 1997, EPA promulgated the first air quality standards for PM 2.5 . See 62 FR 38652. EPA promulgated a 24-hour standard of 65 μg/m 3 , based on a 3-year average of the 98th percentile of 24-hour concentrations. 4 On October 17, 2006, EPA revised the 24-hour NAAQS to 35 μg/m 3 , based again on the 3-year average of the 98th percentile of 24-hour concentrations. See 71 FR 61144. 5 Under EPA regulations at 40 CFR part 50, the primary and secondary 2006 24-hour PM 2.5 NAAQS are attained when the 3-year average of the 98th percentile of 24-hour concentration, as determined in accordance with 40 CFR part 50, Appendix N, is less than or equal to 35 μg/m 3 at all relevant monitoring sites in the subject area over a 3-year period.

Following promulgation of a new revised NAAQS, EPA is required by the CAA to designate areas throughout the nation as attaining or not attaining the NAAQS. On November 13, 2009, EPA promulgated designations for the 2006 24-hour PM 2.5 NAAQS, designating the Birmingham Area, which includes Jefferson County, Shelby County, and a portion of Walker County, as nonattainment for the 2006 24-hour PM 2.5 NAAQS based upon air quality data for calendar years 2006 through 2008. See 74 FR 58688. Under the CAA, States are also required to adopt and submit SIPs to implement, maintain, and enforce the NAAQS in designated nonattainment areas and throughout the State.

A State may submit a request to redesignate a nonattainment area that is attaining the NAAQS, and, if the area has met the required criteria described in section 107(d)(3)(E) of the CAA, EPA may approve the redesignation to attainment for the area. 6 One of the criteria for redesignation is to have an approved maintenance plan under CAA section 175A. The maintenance plan must demonstrate that the area will continue to maintain the NAAQS for the period extending 10 years after redesignation, and it must contain such additional measures as necessary to ensure maintenance and such contingency provisions as necessary to assure that violations of the NAAQS will be promptly corrected. Eight years after the effective date of redesignation, the State must also submit a second maintenance plan to ensure ongoing maintenance of the NAAQS for an additional ten years pursuant to CAA section 175A(b) ( i.e., ensuring maintenance for 20 years after redesignation).

In 2009, the Birmingham Area was designated as nonattainment for the 2006 24-hour PM 2.5 NAAQS. On June 17, 2010, ADEM submitted to EPA a request to redesignate the Birmingham Area to attainment for the 2006 24-hour PM 2.5 NAAQS. This submittal included a plan to provide for maintenance of the 2006 24-hour PM 2.5 NAAQS in the Birmingham Area through 2024 as a revision to the Alabama SIP. On September 20, 2010, EPA issued a clean data determination under the Agency's Clean Data Policy based upon complete, quality assured, quality controlled, and certified ambient air monitoring data for the years 2007-2009 showing that the Birmingham Area had monitored attainment of the 2006 24-hour PM 2.5 NAAQS. See 75 FR 57186. Subsequently, on January 25, 2013, EPA approved the Birmingham Area's maintenance plan and the State's request to redesignate the Birmingham Area to attainment for the 2006 24-hour PM 2.5 NAAQS. See 78 FR 5306.

EPA has published long-standing guidance for States on developing maintenance plans. 7 The Calcagni Memo provides that States may generally demonstrate maintenance by either performing air quality modeling to show that the future mix of sources and emission rates will not cause a violation of the NAAQS or by showing that projected future emissions of a pollutant and its precursors will not exceed the level of emissions during a year when the area was attaining the NAAQS ( i.e., attainment year inventory). See Calcagni Memo at 9. EPA clarified in subsequent guidance memos that certain areas could meet the CAA section 175A requirement to provide for maintenance by showing that the area was unlikely to violate the NAAQS in the future, using information such as the area's design value  8 being significantly below the standard and the area having a historically stable design value. 9 EPA refers to a maintenance plan containing this streamlined demonstration as an LMP, and in guidance, EPA has discussed certain criteria that it intends to evaluate, including consistency with EPA regulations along with other information as is relevant, in determining if this option is appropriate for an area.

EPA has interpreted CAA section 175A as permitting the LMP option because section 175A of the Act does not define how areas may provide for maintenance, and in EPA's experience implementing the various NAAQS, areas that qualify for an LMP and have approved LMPs have rarely, if ever, experienced subsequent violations of the NAAQS. As noted in EPA's LMP guidance, States seeking an LMP must still submit the other maintenance plan elements outlined in the Calcagni Memo, including: an attainment emissions inventory, provisions for the continued operation of the ambient air quality monitoring network, verification of continued attainment, and a contingency plan in the event of a future violation of the NAAQS. Moreover, a State seeking an LMP as its section 175A maintenance plan must submit it as a revision to its SIP, with all attendant notice and comment procedures. While the LMP guidance memoranda were originally written with respect to certain NAAQS, 10 EPA has extended the LMP interpretation of section 175A to certain other NAAQS and pollutants not specifically covered by the previous guidance memos. 11

At the time ADEM was developing its February 2, 2021, SIP revision, EPA had not developed specific LMP guidance for PM 2.5 , and ADEM consulted with the Agency in extending the rationale from the 2001 PM 10 LMP Guidance, which was written for particulate matter with an aerodynamic diameter of 10 microns or less (PM 10 ), to the PM 2.5 maintenance plan. 12 Accordingly, ADEM prepared its second maintenance plan submission in accordance with the 2001 PM 10 LMP Guidance. Since the time of the February 2, 2021, submittal, EPA has released LMP guidance for PM 2.5 . Specifically, on October 27, 2022, EPA published clarifying guidance that focuses on the distinctions that are relevant specifically for PM 2.5 LMPs for Moderate PM 2.5 Nonattainment and PM 2.5 Maintenance Areas. 13 The 2022 PM 2.5 LMP Guidance applies the 2001 Limited Maintenance Plan Option for Moderate PM 10 Nonattainment Areas guidance for PM 2.5 LMP submissions, except for the specific topics where the 2001 guidance is superseded. Therefore, EPA has evaluated the February 2, 2021, submittal in light of the criteria discussed in the 2022 PM 2.5 LMP Guidance, as well as the relevant statutory and regulatory requirements.

EPA is proposing to approve the Birmingham Area LMP because the State has made a showing, consistent with EPA's current PM 2.5 LMP guidance, that the Birmingham Area's PM 2.5 concentrations are well below the 2006 24-hour PM 2.5 NAAQS and have been historically stable, and that it has met the other maintenance plan requirements. EPA's evaluation of the Birmingham Area LMP is presented in Section IV of this notice of proposed rulemaking (NPRM).

Under CAA section 175A(b), States must submit a revision to the first maintenance plan eight years after redesignation to provide for maintenance of the NAAQS for ten additional years following the end of the first 10-year period. Accordingly, on February 2, 2021, Alabama submitted a second maintenance plan for the Birmingham Area that shows that the Area is expected to remain in attainment of the 2006 24-hour PM 2.5 NAAQS through 2034, i.e., through the end of the full 20-year maintenance period.

In recognition of the continuing record of air quality monitoring data showing ambient 24-hour PM 2.5 concentrations in the Birmingham Area well below the 2006 24-hour PM 2.5 NAAQS, ADEM chose the LMP option for the development of a second 2006 24-hour PM 2.5 NAAQS maintenance plan. On February 2, 2021, ADEM adopted the second 10-year maintenance plan for the 2006 24-hour PM 2.5 NAAQS and submitted the Birmingham Area LMP to EPA as a revision to the Alabama SIP.

The February 2, 2021, submittal includes the LMP, air quality data and other information demonstrating qualification for the LMP, emissions inventory information, and appendices, as well as certification of adoption of the plan by ADEM. Appendices to the plan include a copy of the 2001 PM 10 LMP Guidance, supplemental information on ADEM's mobile source emissions analysis, emissions inventory development data, and qualifying calculations in accordance with the 2001 PM 10 LMP Guidance. The submittal also includes documentation of notice, hearing, and public participation prior to adoption of the plan by ADEM on February 2, 2021. The Birmingham Area LMP relies on the same emission reduction strategy and other already-implemented measures as the Area's first 10-year maintenance plan, which provides for the maintenance of the 2006 24-hour PM 2.5 NAAQS through 2024. Specifically, the Birmingham Area LMP relies on the following measures: the continuation of programs such as the local Jefferson County and Shelby County burn bans, prioritizing funding for diesel emissions reduction projects within the Birmingham Area, continued implementation of Federal measures (for example, Tier 3 Motor Vehicle Emission and Fuel Standards, 14 and interstate transport rules  15 ), and emission reductions achieved and documented for the first CAA section 175A maintenance plan. 16 Since Alabama submitted its maintenance plan for the first 10-year portion of the maintenance period, other changes that have decreased PM 2.5 and precursor emissions in the Area have taken place, as noted in the February 2, 2021, submittal. Examples include the permanent shutdown of Units 1-5 at the Tennessee Valley Authority's Colbert Plant, the permanent shutdown of Alabama Power Company's Plant Gorgas, the installation of a baghouse with an electrostatic precipitator at Alabama Power Company's Plant Gaston, and the conversion of the coal-fired units to natural gas at Alabama Power Company's Greene County Steam Plant. 17

EPA has reviewed the Birmingham Area LMP, which is designed to maintain the 2006 24-hour PM 2.5 NAAQS within the Birmingham Area through the end of the 20-year period beyond redesignation, as required under CAA section 175A(b). The following is a summary of EPA's interpretation of the section 175A requirements  18 and EPA's evaluation of how each requirement is met.

For maintenance plans, a State should develop a comprehensive, accurate inventory of actual emissions for an attainment year to identify the level of emissions which is sufficient to maintain the NAAQS. A State should develop this inventory consistent with EPA's most recent guidance on emissions inventory development. For the 24-hour PM 2.5 NAAQS, the inventory should be based on representative daily emissions of direct PM 2.5 and precursor emissions, including SO 2 , NO X , VOC, and NH 3 . The Birmingham Area LMP includes a PM 2.5 attainment inventory for the Birmingham Area with emissions from 2017. Table 1 presents a summary of the inventory for 2017 contained in the LMP for PM 2.5 and precursor emissions.

The Attainment Emissions Inventory section of the Birmingham Area LMP describes the methods, models, and assumptions used to develop the attainment inventory. As described in the Attainment Emissions Inventory section of the LMP, ADEM relied on the 2017 National Emissions Inventory (NEI) for point source, non-point (or area source), and event emissions (which typically consist of activities such as wildfires), except as described below. 19

Nonroad mobile source emissions were, in part, estimated using the latest version of the EPA's motor vehicle emissions model, MOVES3 (which provides the ability to estimate nonroad emissions from agricultural, commercial, mining, industrial, and recreational equipment, and commercial and residential lawn and garden equipment, among others). Locomotives, aircraft, and marine nonroad sources are not included in MOVES, and ADEM relied on EPA-generated emissions for these sectors. 20 ADEM estimated on-road mobile source emissions using MOVES3 and local data such as vehicle type, activity, and vehicle speeds from the Birmingham metropolitan planning organization (MPO) to estimate vehicular emissions for 2017. ADEM's estimates for vehicles reflect emissions inventories and ancillary data files used for emissions modeling, as well as the meteorological, initial condition, and boundary condition files needed to run the air quality model.

Based on EPA's review of the methods, models, and assumptions used by Alabama to develop the inventory, as well as EPA's review of the 2017 daily emissions data, EPA proposes to find that the Birmingham Area LMP includes a comprehensive, accurate inventory of actual PM 2.5 and precursor emissions in attainment year 2017 and proposes to conclude that this is acceptable for the purposes of a maintenance plan under CAA section 175A(b).

The maintenance demonstration requirement is considered to be satisfied in an LMP if the State can provide sufficient weight of evidence indicating that air quality in the area is well below the level of the NAAQS, that past air quality trends have been shown to be stable, and that the probability of the area experiencing a violation during the second 10-year maintenance period is low. 21 These criteria are evaluated below with regard to the Birmingham Area. As noted in Section II of this NPRM, EPA has evaluated ADEM's submittal and, considering the submittal's contents and EPA's conclusions based thereon, finds the LMP to be consistent with EPA's current LMP guidance for PM 2.5 Maintenance Areas. Although ADEM developed the Birmingham Area LMP in accordance with the 2001 PM 10 LMP Guidance, the LMP is nonetheless consistent with the portions of the 2022 PM 2.5 LMP Guidance that superseded the 2001 PM 10 LMP Guidance.

To attain the 2006 24-hour PM 2.5 NAAQS, the three-year average of the 98th percentile 24-hour average PM 2.5 concentrations (design value) at each monitor within an area must not exceed 35 μg/m 3 . Table 2 includes the Area-wide monitor design values for the 2006 24-hour PM 2.5 NAAQS from EPA's Air Quality System (AQS) for the period 2015-2019, which covers the overall period from 2013-2019. 22

From the available data in Table 2, the representative complete DV for the Birmingham Area was the North Birmingham monitor DV for each three-year period. The highest complete DV in this time period is 23 µg/m 3 , which is 66% of the 24-hour NAAQS. The most recent official DVs are for 2020-2022 and are as follows: North Birmingham, 17 μg/m 3 ; McAdory, 17 μg/m 3 ; Leeds, 18 μg/m 3 ; and Wylam, 18 μg/m 3 . These most recent data are slightly lower than those presented in Table 2 and continue to show the general downward trend. 23

Section 111(d) of the CAA requires the EPA to establish a procedure for a state to submit a plan to the EPA that establishes standards of performance for any air pollutant: (1) for which air quality criteria have not been issued or which is not included on a list published under CAA section 108 or emitted from a source category which is regulated under CAA section 112 and (2) to which a standard of performance under CAA section 111 would apply if such existing source were a new source. Section 129(b)(2) of the CAA requires that after the EPA promulgates guidelines for a category of solid waste incineration units, each state in which units in the category are operating shall submit to the EPA a plan to implement and enforce the guidelines with respect to such units. Such plans shall be at least as protective as the guidelines promulgated by the EPA. The EPA established requirements for State Plan submittals in the Code of Federal Regulations (CFR) at 40 CFR part 60, subpart B. State submittals under CAA sections 111(d) and 129 must be consistent with the relevant emission guidelines, in this instance 40 CFR part 60, subpart Cb, and the requirements of 40 CFR part 60, subpart B.

On May 10, 2006, the EPA revised the regulations established for Emissions Guidelines and Compliance Times for Large MWC That Are Constructed on or before September 20, 1994, in 40 CFR part 60, subpart Cb (71 FR 27324). This action was taken under sections 111(d) and 129 of the CAA.

On July 18, 2022, SRCAA submitted to the EPA a section 111(d)/129 plan for existing large MWC. The submitted section plan was in response to the May 10, 2006, promulgation of Federal emission guidelines requirements for large MWC, 40 CFR part 60, subpart Cb (71 FR 27336).

The EPA has reviewed the SRCAA section 111(d)/129 plan submittal in the context of the requirements of 40 CFR part 60, subparts B and Cb. In this action, the EPA is proposing to determine that SRCAA's section 111(d)/129 plan meets the cited Federal requirements, except with regard to fluidized bed combustors and air curtain incinerators. On April 5 2007, SRCAA amended Regulation I, Article VI, Section 6.17 to incorporate the EPA's revisions to the Emission Guidelines for large MWC and made administrative formatting updates, adopted on July 9, 2020. The primary mechanism used by SRCAA to implement the Emission Guidelines for existing large MWC under state jurisdiction is through incorporation by reference of 40 CFR part 60, subpart Cb requirements into Regulation 1, Article VI, Section 6.17. The changes SRCAA made to the language in the Emission Guidelines were made to convert the language in the Emission Guidelines to enforceable requirements. Because SRCAA reported that there are only two units at a single facility subject to the proposed State Plan—both of which utilize the mass burn waterwall combustor technology—SRCAA did not include requirements in the Emission Guidelines that apply to fluidized bed combustors (40 CFR 60.33b(d)(3)) or air curtain incinerators (40 CFR 60.37b). In each case, the Emission Guidelines clearly state that “for approval, a State Plan shall include . . .” the specified requirements. The EPA has no discretion to fully approve a State Plan that omits a required element. For this reason, the EPA is proposing to partially disapprove SRCAA's State Plan insofar as it does not address regulatory requirements applicable to fluidized bed combustors and air curtain incinerators.

These regulations will be applicable to existing large MWC in Spokane County, Washington upon the EPA's approval of the plan by final rulemaking, except that fluidized bed combustors and air curtain incinerators that are designated facilities under the Emission Guidelines per 40 CFR 60.32b shall be subject to the Federal Plan Requirements for Large Municipal Waste Combustors Constructed on or before September 20, 1994 (40 CFR part 62, subpart FFF). A more detailed explanation of the rationale behind this proposed approval is available in the Technical Support Document (TSD) that may be found in the docket for this action.

The EPA is proposing to partially approve and partially disapprove the SRCAA section 111(d)/129 plan for large MWC submitted pursuant to 40 CFR part 60, subpart Cb. Therefore, the EPA is proposing to amend 40 CFR part 62, subpart WW to reflect this action.

This partial approval and partial disapproval is based on the rationale previously discussed in this document and in further detail in the TSD that may be found in the docket for this action. The scope of the proposed partial approval of the section 111(d)/129 plan is limited to the provisions of 40 CFR part 60, subpart Cb that apply to existing large MWC in Spokane County that are not fluidized bed combustors or air curtain incinerators. The EPA Administrator continues to retain the authorities identified in 40 CFR 60.30b(b) as authorities retained by the Administrator.

In this document, the EPA is proposing to include regulatory text that incorporates by reference the State Plan. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference SRCAA Regulation I, Article VI, Section 6.17, which became effective within the SRCAA's jurisdiction on July 7, 2022. The regulatory provisions of this section of the SRCAA rule incorporate all the CAA 111(d)/129 State Plan elements required by the EG for existing large MWC promulgated at 40 CFR part 60, subpart Cb. The emissions standards and compliance times established within the SRCAA State Plan are at least as stringent as those required by the EG for existing large MWC subject to subpart Cb. The EPA has made, and will continue to make, these materials generally available through the docket for this action, EPA-R10-OAR-2023-0224, at https://www.regulations.gov and at EPA Region 10 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

In reviewing State Plan submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this 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 an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

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

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

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 air agency did not evaluate environmental justice considerations as part of its submittal; the Clean Air Act 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. Due to the nature of this action, it is expected to have a neutral to positive impact on the air quality of the affected area. 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 Executive Order 12898 of achieving environmental justice for people of color, low-income populations, and Indigenous peoples.

In addition, this proposed rulemaking would not apply on any Indian reservation land or in any other area in Washington where the EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the proposed rule would not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).