The substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. Therefore, the FAA finds, pursuant to 14 CFR 11.38(b), that new comments are unlikely, and notice and comment prior to this publication are unnecessary.

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 https://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 Thuan T. Nguyen, Avionics Software & Components Unit, AIR-626D, Technical Innovation Policy Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3365; email Thuan.T.Nguyen@faa.gov. Comments the FAA receives, which are not specifically designated as CBI, will be placed in the public docket for these special conditions.

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 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.

On June 30, 2021, Textron Aviation, Inc. applied for an Amended Type Certificate (ATC) for the installation of a digital systems architecture that will allow increased connectivity to and access from external network sources, ( e.g., operator networks, wireless devices, internet connectivity, service provider satellite communications, electronic flight bags, etc.) to the airplane's previously isolated electronic assets (networks, systems, and databases). The Textron Model 560XL(XLS+) airplane, which is a derivative of the Model 560XL currently approved under Type Certificate No. A22CE, is a two-engine transport category airplane. The maximum seating capacity is 12 passengers and 2 crew members. The maximum takeoff weight is 20,200 to 20,330 pounds, depending on the specific variant.

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Textron Aviation, Inc. must show that the Model 560XL(XLS+) airplane, as changed, continues to meet the applicable provisions of the regulations listed in Type Certificate No. A22CE 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 Textron Model 560XL(XLS+) airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for an ATC 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 under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the Textron Model 560XL(XLS+) airplane must comply with the 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 Textron Model 560XL(XLS+) airplane will incorporate a novel or unusual design feature, which is the installation of a digital systems architecture that will allow increased connectivity to and access from external network sources, ( e.g., operator networks, wireless devices, internet connectivity, service provider satellite communications, electronic flight bags, etc.) to the airplane's previously isolated electronic assets (networks, systems, and databases).

The Textron Model 560XL(XLS+) airplane electronic system architecture and network configuration is novel or unusual for commercial transport airplanes because it may allow increased connectivity to and access from external network sources, airline operations, and maintenance networks, to the airplane control domain and airline information services domain. The airplane's control domain and airline information-services domain perform functions required for the safe operation and maintenance of the airplane. Previously, these domains had very limited connectivity with external network sources. This data network and design integration creates a potential for unauthorized persons to access the aircraft-control domain and airline information-services domain, and presents security vulnerabilities related to the introduction of computer viruses and worms, user errors, and intentional sabotage of airplane electronic assets (networks, systems, and databases) critical to the safety and maintenance of the airplane.

The existing FAA regulations did not anticipate these networked airplane-system architectures. Furthermore, these regulations and the current guidance material do not address potential security vulnerabilities, which could be exploited by unauthorized access to airplane networks, data buses, and servers. Therefore, these special conditions ensure that the security ( i.e., confidentiality, integrity, and availability) of airplane systems is not compromised by unauthorized wired or wireless electronic connections. This includes ensuring that the security of the airplane's systems is not compromised during maintenance of the airplane's electronic systems. These special conditions also require the applicant to provide appropriate instructions to the operator to maintain all electronic-system safeguards that have been implemented as part of the original network design so that this feature does not allow or introduce security threats.

These 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 special conditions are applicable to the Textron Model 560XL(XLS+) airplane. Should Textron Aviation, Inc. apply at a later date for ATC to modify any other model included on Type Certificate No. A22CE to incorporate the same novel or unusual design feature, these special conditions would apply to that model as well.

This action affects only a certain novel or unusual design feature on the Textron Model 560XL(XLS+) airplane. It is not a rule of general applicability.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Textron Model 560XL(XLS+) airplane for airplane electronic unauthorized external access.

1. The applicant must ensure airplane electronic-system security protection from access by unauthorized sources external to the airplane, including those possibly caused by maintenance activity.

2. The applicant must ensure airplane electronic system security threats are identified and assessed, and that effective electronic system security protection strategies are implemented to protect the airplane from all adverse impacts on safety, functionality, and continued airworthiness.

3. The applicant must establish appropriate procedures to allow the operator to ensure that continued airworthiness of the airplane is maintained, including all post-type-certification modifications that may have an impact on the approved electronic-system security safeguards.

The substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. Therefore, the FAA finds, pursuant to 14 CFR 11.38(b), that new comments are unlikely, and notice and comment prior to this publication are unnecessary.

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 https://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 Thuan T. Nguyen, Avionics Software & Components Unit, AIR-626D, Technical Innovation Policy Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3365; email Thuan.T.Nguyen@faa.gov. Comments the FAA receives, which are not specifically designated as CBI, will be placed in the public docket for these special conditions.

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 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.

On June 30, 2021, Textron Aviation, Inc. applied for an amended type certificate (ATC) for the installation of a digital system that contains a wireless and hardwired network with hosted application functionality that allows access, from sources internal to the airplane, to the airplane's internal electronic components. The Textron Model 560XL(XLS+) airplane, which is a derivative of the Model 560XL currently approved under Type Certificate No. A22CE, is a two-engine transport category airplane. The maximum seating capacity is 12 passengers and 2 crew members. The maximum takeoff weight is 20,200 to 20,330 pounds, depending on the specific variant.

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Textron must show that the Model 560XL(XLS+) airplane, as changed, continues to meet the applicable provisions of the regulations listed in Type Certificate No. A22CE 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 Textron Model 560XL(XLS+) airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for an ATC 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 Textron Model 560XL(XLS+) airplane must comply with the 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 Textron Model 560XL(XLS+) airplane will incorporate a novel or unusual design feature, which is the installation of a digital system that contains a wireless and hardwired network with hosted application functionality that allows access, from sources internal to the airplane, to the airplane's internal electronic components.

The Textron Model 560XL(XLS+) airplane electronic system architecture and network configuration change is novel or unusual for commercial transport airplanes because it is composed of several connected wireless and hardwired networks. This proposed system and network architecture is used for a diverse set of airplane functions, including:

• Flight-safety related control and navigation systems,

• Airline business and administrative support, and

• Passenger entertainment.

The airplane's control domain and airline information services domain of these networks perform functions required for the safe operation and maintenance of the airplane. Previously, these domains had very limited connectivity with other network sources. This network architecture creates a potential for unauthorized persons to access the aircraft control domain from sources internal to the airplane, and presents security vulnerabilities related to the introduction of computer viruses and worms, user errors, and intentional sabotage of airplane electronic assets (networks, systems, and databases) critical to the safety and maintenance of the airplane.

The existing FAA regulations did not anticipate these networked airplane-system architectures. Furthermore, these regulations and the current guidance material do not address potential security vulnerabilities, which could be exploited by unauthorized access to airplane networks, data buses, and servers. Therefore, these special conditions ensure that the security ( i.e., confidentiality, integrity, and availability) of airplane systems will not be compromised by unauthorized wireless or hardwired electronic connections from within the airplane. These special conditions also require the applicant to provide appropriate instruction to the operator to maintain all electronic-system safeguards that have been implemented as part of the original network design so that this feature does not allow or reintroduce security threats.

These 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 special conditions are applicable to the Textron Model 560XL(XLS+) airplane. Should Textron apply at a later date for an amended type certificate to modify any other model included on Type Certificate No. A22CE to incorporate the same novel or unusual design feature, these special conditions would apply to that model as well.

This action affects only a certain novel or unusual design feature on Textron Model 560XL(XLS+) airplane. It is not a rule of general applicability.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Textron 560XL(XLS+) airplane for airplane electronic-system internal access.

1. The applicant must ensure that the design provides isolation from, or airplane electronic-system security protection against, access by unauthorized sources internal to the airplane. The design must prevent inadvertent and malicious changes to, and all adverse impacts upon, airplane equipment, systems, networks, and other assets required for safe flight and operations.

2. The applicant must establish appropriate procedures to allow the operator to ensure that continued airworthiness of the airplane is maintained, including all post-type-certification modifications that may have an impact on the approved electronic-system security safeguards.

The substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. Therefore, the FAA finds, pursuant to § 11.38(b), that new comments are unlikely, and notice and comment prior to this publication are unnecessary.

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 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. The FAA may change these special conditions based on the comments received.

On September 16, 2019, Airbus applied for an amendment to Type Certificate No. A28NM to include the new Model A321neo XLR airplanes, which include the Model A321-271NY and -253NY airplanes. These airplanes are twin-engine, transport-category airplanes with seating for 244 passengers and a maximum takeoff weight of 222,000 pounds.

Under the provisions of 14 CFR 21.101, Airbus must show that the Model A321neo XLR airplanes meet the applicable provisions of the regulations listed in Type Certificate No. A28NM, 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 A321neo XLR airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified 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 A321neo XLR airplanes 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 § 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.

The Airbus Model A321neo XLR airplanes will incorporate the following novel or unusual design feature: Side-stick controllers for pitch and roll control.

These proposed special conditions for the Airbus A321neo XLR airplane address the novel features of the side-stick controllers. The A321neo XLR will incorporate side-stick controllers controlling a fly-by-wire (FBW) electronic flight control system (EFCS). This system provides an electronic interface between the pilot's flight controls and the flight control surfaces for both normal and failure states, and it generates the actual surface commands that provide for stability augmentation and control about all three airplane axes. In addition, pilot control authority may be uncertain, because the side-stick controllers are not mechanically interconnected as with conventional wheel and column controls.

Current FAA regulations do not specifically address the use of side-stick controllers for pitch and roll control. The unique features of the side stick must therefore be demonstrated through flight and simulator tests to have suitable handling and control characteristics when considering the following:

1. The handling-qualities tasks and requirements of the Airbus Model A321neo XLR airplane special conditions, and other 14 CFR part 25 requirements for stability, control, and maneuverability, including the effects of turbulence.

2. General ergonomics: Armrest comfort and support, local freedom of movement, displacement angle suitability, and axis harmony.

3. Inadvertent input in turbulence.

4. Inadvertent pitch-roll crosstalk.

The FAA Handling Qualities Rating Method (HQRM) of Appendix E of the Flight Test Guide for Certification of Transport Category Airplanes, AC 25-7D, may be, but is not required to be, used to show compliance.

These 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 special conditions apply to Airbus Model A321neo XLR airplanes. Should Airbus apply later for a change to the type certificate to include another model incorporating the same novel or unusual design feature, the special conditions would apply to that model as well.

This action affects only certain novel or unusual design features on one model series of airplanes. It is not a rule of general applicability.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Airbus Model A321neo XLR airplanes.

(a) Pilot Strength. In lieu of the “strength of pilots” limits of § 25.143(d) for pitch and roll, and in lieu of the specific pitch force requirements of §§ 25.145(b) and 25.175(d), the following applies:

The applicant must show that the temporary and maximum prolonged force levels for the side-stick controllers are suitable for all expected operating conditions and configurations, whether normal or non-normal.

(b) Controller Coupling. The electronic side-stick controller coupling design must provide for corrective and/or overriding control inputs by either pilot with no unsafe characteristics. Annunciation of controller status must be provided and must not be confusing to the flightcrew.

(c) Pilot Control. The applicant must show by flight tests that the use of side-stick controllers does not produce unsuitable pilot-in-the-loop control characteristics when considering precision path control tasks and turbulence. In addition, pitch and roll control-force sensitivity and displacement sensitivity must be compatible, so that normal inputs on one control axis will not cause significant unintentional inputs on the other.

I. Background and Statutory Authority

In 2013, the CPSC received two requests to initiate rulemaking proceedings under the Consumer Product Safety Act (CPSA) to address an unreasonable risk of injury associated with APBRs. Gloria Black, the National Consumer Voice for Quality Long-Term Care, Consumer Federation of America, and 60 other organizations submitted one request; Public Citizen Health Research Group submitted the other request. Collectively, the petitioners stated that many of the deaths and injuries involving APBRs result from asphyxiation caused by entrapment within openings of the APBR rail or between the rail and the mattress or bed frame. The petitioners requested that the CPSC initiate rulemaking proceedings under section 8 of the CPSA to ban all APBRs. Alternatively, petitioners requested that the Commission initiate a rulemaking under section 9 of the CPSA to promulgate mandatory standards, including warning labels, to reduce the unreasonable risk of asphyxiation and entrapment posed by APBRs. Petitioners also requested action under section 27(e) of the CPSA to require manufacturers of APBRs to provide performance and technical data regarding the safety of their products.

The CPSC docketed the petition requests as a single petition: Petition CP 13-1, Petition Requesting a Ban or Standard on APBRs under the CPSA. On June 4, 2013, the Commission published a notice in the Federal Register seeking public comment on the petition. 78 FR 33393. Also in 2013, ASTM International (ASTM) formed the ASTM F15.70 subcommittee to begin developing a voluntary standard for APBRs.

On April 23, 2014, staff sent a briefing package on APBRs to the Commission (Staff's 2014 briefing package). 1 In that briefing package, staff recommended the Commission defer a decision on the petition until a voluntary standard for APBRs was developed and evaluated by staff. On April 29, 2014, the Commission voted to defer the petition pending ASTM's further work on a voluntary standard.

On April 28, 2015, the Commission voted again to defer a decision on the petition to allow the ASTM voluntary standard development process additional time to continue. Throughout this period, staff participated in the ASTM F15.70 subcommittee to develop the voluntary standard for APBRs. In August 2017, ASTM published the voluntary standard, ASTM F3186-17, Standard Specification for Adult Portable Bed Rails and Related Products.

On July 15, 2020, staff provided the Commission its review of ASTM F3186-17 (Staff's 2020 briefing package). 2 Staff indicated that ASTM F3186-17 would adequately address the hazards identified in the known incident reports if there were certain modifications to the labeling, warning statements, and instructional literature requirements and to physical test requirements. However, when staff assessed compliance to the voluntary standard, staff found no market compliance with the voluntary standard.

In June 2020, CPSC's Office of Compliance sent a letter to 19 known APBR manufacturers, urging industry members to stop manufacturing, distributing, and selling APBRs that do not comply with ASTM F3186-17. Staff also continued to engage actively at the ASTM F15.70 subcommittee meetings. Staff presented and explained its testing results to the subcommittee members, provided the subcommittee with Compliance's letter to industry, supplied updated incident data for the subcommittee's review, and participated as technical experts on all subcommittee task groups.

On March 9, 2022, staff sent to the Commission another briefing package regarding ASTM F3186-17 (Staff's 2022 briefing package). 3 That briefing package updated the Staff's 2020 briefing package with incident data that included all known APBR safety incidents from January 2003 through September 2021. In addition, Staff's 2022 briefing package discussed the results of the two rounds of testing staff had conducted on APBRs, and the continuing lack of compliance with ASTM's voluntary standard. Staff recommended that the Commission grant the petition and direct staff to prepare a notice of proposed rulemaking (NPR) to address the entrapment hazards associated with APBRs. On March 16, 2022, the Commission voted to grant Petition CP 13-1 and directed staff to proceed with a draft NPR.

On September 21, 2022, staff sent the Commission an NPR briefing package for APBRs. 4 On October 13, 2022, the Commission voted to publish the NPR for APBRs in the Federal Register . On November 9, 2022, the Commission published its NPR in the Federal Register , determining preliminarily that there is an unreasonable risk of injury and death associated with entrapment hazards from APBRs. To address those risks, the Commission proposed a rule under the CPSA that would require APBRs to meet the requirements of the ASTM F3186-17 voluntary standard, with modifications. 87 FR 67586. The Commission received seven written comments regarding the NPR. Although the Commission offered an opportunity for interested parties to present oral comments on the NPR, the Commission did not receive any requests to provide oral comments.

In this final rule, the Commission determines that APBRs pose an unreasonable risk of injuries and deaths associated with entrapment hazards. 5 To address this risk, the Commission adopts ASTM F3186-17, with modifications, to improve the safety of APBRs. The information discussed in this preamble is derived primarily from CPSC staff's briefing package for the NPR and briefing package for the final rule (staff's final rule briefing package). 6

This final rule is authorized by the CPSA, 15 U.S.C. 2051-2084. Section 7(a) of the CPSA authorizes the Commission to promulgate a mandatory consumer product safety standard that sets forth performance or labeling requirements for a consumer product if such requirements are reasonably necessary to prevent or reduce an unreasonable risk of injury. 15 U.S.C. 2056(a). Section 9 of the CPSA specifies the procedure that the Commission must follow to issue a consumer product safety standard under section 7 of the CPSA. In accordance with section 9, the Commission is issuing this final rule for APBRs.

According to section 9(f)(1) of the CPSA, before promulgating a consumer product safety rule the Commission must consider, and make appropriate findings to be included in the rule, on the following issues:

• The degree and nature of the risk of injury that the rule is designed to eliminate or reduce;

• The approximate number of consumer products subject to the rule;

• The need of the public for the products subject to the rule and the probable effect the rule will have on utility, cost, or availability of such products; and

• Any means to achieve the objective of the rule while minimizing adverse effects on competition, manufacturing, and commercial practices.

15 U.S.C. 2058(f)(1).

Under section 9(f)(3) of the CPSA, to issue a final rule, the Commission must find that the rule is “reasonably necessary to eliminate or reduce an unreasonable risk of injury associated with such product” and that issuing the rule is in the public interest. Id. 2058(f)(3)(A) and (B). Additionally, if a voluntary standard addressing the risk of injury has been adopted and implemented, the Commission must find that:

• The voluntary standard is not likely to eliminate or adequately reduce the risk of injury, or

• Substantial compliance with the voluntary standard is unlikely.

Several types of bed rails under CPSC jurisdiction are available to consumers. 7 ASTM F3186-17 (section 1.2) describes “portable bed rails and related products” as products installed by consumers and “not designed as part of the bed by the bed manufacturer.” Generally, APBRs within CPSC's jurisdiction include products that are installed or used alongside a bed by consumers and are intended to reduce the risk of falling from the bed, assist the consumer in repositioning in the bed, or assist the consumer in transitioning into or out of the bed. Figure 1 below shows four common types of APBRs.

Because of the similarity in design and means of attachment to the side of the bed, products intended for both types of uses can present the same potential entrapment hazards, as discussed in section III of this preamble.

In September and October 2021, CPSC staff conducted an online search that identified 12 firms supplying 65 distinct APBR models. Retail prices for the identified APBR models ranged from $38 to $275. Based on an interview with one APBR manufacturer's representative and market information from the identified APBR models, CPSC staff estimates that in 2021, the mean retail price was $50 per APBR; total market revenues were approximately $9 million; and the number of APBRs sold that year was approximately 180,000 units. See Tab C of the staff's briefing package for the final rule for additional details.

In the NPR proceeding, CPSC staff summarized the data on deaths and injuries involving APBRs. See Tab A: Division of Hazard Analysis: Directorate for Epidemiology (EPHA) of the staff NPR briefing package. In particular, staff reviewed Consumer Product Safety Risk Management System (CPSRMS) injury cases and National Electronic Injury Surveillance System (NEISS) injury cases that occurred in the period from January 1, 2003, through December 31, 2021. The Commission received no comments on that analysis. The final regulatory analysis is substantively the same as the preliminary analysis.

Staff identified a total of 332 incident reports for the period January 2003 to December 2021. Of these, 310 were reports of fatalities, and 22 were reports of nonfatal incidents. Most of the incidents were identified from death certificates, medical examiner reports, or coroner reports. Death certificate data often have lag time of approximately two to three years from the initial date of reporting. As the APBR data in CPSRMS are heavily reliant on death certificates, data collection is ongoing and incident data for 2020 and 2021 should be considered incomplete and likely to increase.

The remaining incidents were extracted from various sources including newspaper clippings, consumer reports, and manufacturer and retailer reports to CPSC. These documents contain limited information on incident scenarios. The age range of victims in the 305 fatal incidents for which age was reported was 14 to 103 years. More than 75 percent of the incident victims were age 70 or older, and almost 80 percent of the reported fatalities involved victims 70 or older. Table 1 below presents the distribution of these APBR incidents by age.

Table 2 details the distribution of these APBR-related incidents by gender. Approximately 70 percent of all incident victims and incident fatalities were female.

Approximately 50 percent of all APBR-related incidents and fatalities occurred at home. Other commonly reported locations included nursing homes, assisted living facilities, and residential institutions. 8 Table 3 below shows the frequency of each location reported.

The majority of reports, 58 percent, indicated that the victim suffered from at least one underlying medical condition. Almost 34 percent were reported to have more than one medical condition. Table 4 below summarizes the most common underlying medical conditions reported.

Between January 2003 and December 2021, there were an estimated 79,500 injuries related to adult bed rails treated in hospital emergency departments (EDs) across the United States. There was a statistically significant increasing trend in injuries during this period. In the vast majority of NEISS cases, there was insufficient information available in the case narrative for CPSC staff to determine whether the bed rail product involved was specifically an adult portable bed rail, or another type of bed rail; only one case narrative specifies the product involved as an adult portable bed rail. Hence, the estimates presented in Table 5, which provides an overview of the estimated number of adult bed rail-related injuries per year, may be an overestimate. An estimated injury rate per 100,000 population has also been calculated, based on estimates of population ages 13 and older provided by the U.S. Census Bureau.

The vast majority (88 percent) of the ED patients were treated and released or examined and released without treatment, while approximately 11 percent were hospitalized or held for observation. There was only one NEISS case that involved a death; the remaining 1,945 involving nonfatal injuries. The one NEISS case involving a death is separate from any of the CPSRMS incidents, and it was unclear what specific type of product was involved.

As explained in Tabs B and C of staff's NPR briefing package, the vast majority of incident victims in CPSRMS were members of vulnerable populations.

• More than 75 percent of the victims were age 70 or older.

• More than 80 percent of the reported fatalities involved victims ages 70 or older.

• Fifty-eight percent of victims suffered from at least one underlying medical condition.

• Almost 34 percent of victims were reported to have more than one medical condition.

Staff grouped the hazard types into four categories based on the bed rail's role in the incident. The categories are listed in order of highest to lowest frequency.

• Rail Entrapment: There were 284 fatalities and two not-fatal injuries related to rail entrapment. This category includes incidents in which the victim was caught, stuck, wedged, or trapped between the mattress/bed and the bed rail, between bed rail bars, between a commode and rail, between the floor and rail, between the night table and rail, or between a dresser and rail. Based on the narratives, the most frequently injured body parts were the neck and head.

• Falls: There were 23 deaths, one nonfatal knee fracture, and one non- injury incident related to falls. This category includes incidents in which the victim fell off the bed, fell and hit the bed rail, or hit and fell near the bed rail, and fell after climbing over the bed rail.

• Structural Integrity: There were 11 incidents related to structural component problems (weld of bed rail broke and bed rail not sturdy). This category includes one laceration, one head bump, one bruise, two unspecified injuries, and six non-injury incidents.

• Miscellaneous: There were 10 incidents with miscellaneous problems (hanging on the bed rail after garment got caught, hand, arm, or leg laceration, pinched radial nerve against the bed rail, complaint about a misleading label, complaint about a bed rail that was noncompliant with the ASTM standard, and a claim against a bed rail manufacturer about an unspecified issue). This category includes three deaths, three lacerations, one pinched nerve, one unspecified injury, and two non-injury incidents.

Rail entrapment, the most common hazard pattern among all reported incidents, accounted for more than 90 percent (284 of 310) of the fatal incidents. A review of the In-Depth Investigations (IDIs)  10 showed that the victims were typically found with their torso between the product and the mattress frame, with their neck resting on the lower bar. Three other hazard patterns were also reported: (1) chin resting on the bar; (2) slumped backwards, partially suspended with the thorax lodged and compressed in the gap between the rail and mattress; and (3) slumped through the bar opening. The medical examiners in these cases listed the cause of death as “positional asphyxia,” with an additional list of “underlying factors” or “contributory causes.” Staff's analysis of the data revealed that the head and neck were the body parts most frequently entrapped, with positional asphyxia (neck against rail) identified as the most common cause of death. Neck compression, with or without airway blockage, can result in death, even when the body remains partially supported, because blood vessels taking blood to and from the brain and the carotid sinuses are located in soft tissues of the neck and are relatively unprotected.

The vast majority of nonfatal incident reports (all reports except one) did not list any underlying medical condition. Of the 310 fatal incidents, approximately 34 percent reported the victim to have multiple medical conditions, and approximately 58 percent of incidents reported at least one underlying medical condition. Preexisting chronic medical conditions or disorders included Alzheimer's disease, dementia, and other mental limitations; Parkinson's disease; cerebral palsy; multiple sclerosis; Lesch-Nyhan syndrome; amyotrophic lateral sclerosis; cancer; cardiovascular disease; and pulmonary disease. Other conditions included victims with stroke, paralysis, seizures, heavy sedation, and drug ingestion. These factors can limit mobility or mental acuity and contribute to the risk of death by entrapment, because individuals with these conditions are particularly vulnerable and often cannot respond to the danger and free themselves. As discussed in Tab B of the staff's NPR briefing package, adult aging issues can contribute to entrapments, including age-related declines in muscular strength, muscular power, motor control and coordination, and balance. Consumers 70 years and older, who are the victims in most APBR-related fatalities, are especially vulnerable to such age-related declines.

CPSC staff identified falls as the second most common hazard pattern associated with APBRs, accounting for 25 incidents (8 percent), 23 of which resulted in a fatality. Staff found that most falls associated with APBRs involve the victim falling against or striking the APBR. A minority of fall-related incidents, according to staff's review, involved the victim deliberately climbing over the APBR.

To issue a final rule under section 9(f)(3) of the CPSA if a voluntary standard addressing the risk of injury has been adopted and implemented, the Commission must find that:

• The voluntary standard is not likely to eliminate or adequately reduce the risk of injury, or

• Substantial compliance with the voluntary standard is unlikely.

Staff's review of ASTM F3186-17 shows that the voluntary standard, with modifications, is likely to eliminate or adequately reduce the entrapment hazards associated with ABPRs. The Commission determines, however, that the voluntary standard is not likely to eliminate or adequately reduce the risk of entrapments on ABPRs without modifications. In addition, based on testing of ABPRs conducted by CPSC staff as discussed below, the Commission determines that substantial compliance with the voluntary standard is unlikely. Accordingly, in the final rule the Commission incorporates by reference ASTM F3186-17, with modifications, to address the entrapment hazards associated with APBRs.

ASTM F3186-17 establishes performance requirements for APBRs, including requirements for resistance to entrapment, marking and labeling, and instructional literature. Section 3.1.1 of ASTM F3186-17 defines “adult portable bed rail” as:

The Commission determines that these definitions are appropriate for addressing hazards associated with APBRs that: (1) are installed or used along the side of a bed and intended to reduce the risk of falling from the bed; (2) assist the consumer in repositioning in the bed; or (3) assist the consumer in transitioning into or out of the bed.

Section 5 of ASTM F3186-17 sets out general requirements. Section 5.1 requires that there will be no hazardous sharp points or edges. Section 5.2 states that any exposed parts shall be smooth and free from rough edges. Section 5.3 requires that products covered by the standard that are installed on an adjustable bed that articulates must meet the performance requirements when the bed is in either the flat or articulated position. General requirements mandating smooth edges on exposed parts improve safety by preventing potential lacerations or skin injuries from APBRs. In addition, testing APBR products on articulating beds allows assessment of openings that could potentially lead to entrapment after the bed is adjusted from the flat position to the articulated position.

In addition to the general requirements, several performance requirements in ASTM F3186-17 are intended to address the risk of injury associated with APBRs. These include requirements for assembly, structural integrity, retention system performance, and fall and entrapment prevention.

Effectively addressing the entrapment hazard associated with APBRs depends upon, among other things, consumers assembling and installing the product properly. ASTM F3186-17 includes performance requirements intended to improve the likelihood that the APBR will be assembled and installed properly. For example:

• Section 6.1 sets forth a requirement for products to include a retention system, which maintains the installed product in position without requiring readjustment of the components. This retention system must be permanently attached to the APBR once it has been assembled and must not be removable without the use of a tool.

• Section 6.2 includes structural integrity requirements that require the product to withstand testing without deforming or changing dimensions.

• Section 6.5 requires that structural components and retention system components must not be capable of being misassembled, which the standard defines as the APBR being assembled in a way that appears functional but would not meet the retention system (section 6.1), structural integrity (section 6.2), entrapment (section 6.3), or openings (section 6.4) requirements.

The requirement that retention systems be permanently attached to the APBR once it has been assembled, and removable only with a tool, reduces the likelihood that consumers will misplace the retention system and increases the likelihood that consumers, including secondary users, will continue to use the retention system. The requirement that structural and retention system components not be misassembled reduces the risk of injury or death that could arise from the consumer omitting key parts of the APBR ( e.g., a center rail) during assembly, in ways that could result in entrapment or other hazards.

Falls were the second most common hazard pattern in the incident data, accounting for 25 incidents (8 percent). If the fall was triggered by the APBR becoming dislodged, or if its position shifted, then these incidents potentially may be addressed by the voluntary standard's structural integrity testing and the requirement of a permanently attached retention system to maintain the installed product in position. However, some fall-related incidents involved the victim deliberately climbing over the APBR and this requirement may not prevent such consumers from falling over the bed rail.

Staff identified entrapment as the most prevalent hazard pattern among the incidents. Section 6.3 of ASTM F3186-17 requires products to be tested to assess the potential for entrapment in four different zones. These zones represent four of the seven sectors identified by the FDA in its 2006 guidance document, Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment (FDA, 2006), as potential areas of entrapment in hospital bed systems. 11 APBRs present a similar entrapment hazard in these four zones. ASTM F3186-17 specifies the FDA probe to test entrapment zones.

Section 8.4 defines the four entrapment zones tested under ASTM F3186-17, which are: (1) within the product; (2) between rail support(s) and the bed mattress, when applicable, under the product; (3) between the product and the mattress; and (4) between the underside of the end of the product and the mattress. Entrapment testing to ASTM F3186-17 is performed using the anthropometric “entrapment test probe,” which is the cone and cylinder tool described in the 2006 FDA guidance document (section 7.2). In addition, some entrapment testing requires using a force gauge to test the force applied on the test probe (section 7.3). Table 6 below, describes the four entrapment zones, with illustrations from the 2006 FDA guidance document of sample entrapments within each of these zones.

Staff's review of the rail entrapment incidents, test requirements, and test methods showed that most of the reported entrapment fatalities involved one of the four zones listed above. Specifically, staff could determine the entrapment location of 214 of the 284 fatal incidents, and all but six of these cases occurred in one of the four zones of entrapment tested in ASTM F3186-17, as shown in Table 7 below. Based on this analysis, it is likely that most of the 70 incidents for which there was insufficient information to identify the location of the entrapment also involved one of these four zones. See staff's briefing packages for the NPR and the final rule.

Staff's evaluation found that APBR entrapments predominantly occur in Zones 1 through 4, and this is consistent with the FDA's finding that these four zones accounted for about 80 percent of hospital bed rail entrapment events reported to the FDA. FDA's recommended dimensional limits for these zones and the anthropometric test probe serve as the basis for the entrapment requirements of ASTM F3186-17. CPSC's review indicates that the performance requirements in the standard, which are based on identified entrapment patterns and related anthropometric data, would effectively address the entrapment hazard patterns related to APBRs with modifications, discussed below, to eliminate or adequately reduce the unreasonable risk of injury of entrapments.

Section 9.1 of ASTM F3186-17 specifies that the labeling on the APBR and its retail packaging must be marked with the type and size of beds and mattresses, including the mattress thickness range for which the APBR is intended. In addition, the labeling and retail packaging on the APBR must state the appropriate distance between an installed APBR and the headboard or footboard of the bed. ASTM F3186-17 requires labeling on the product and its retail packaging to indicate how to correctly install the ABPR at the specified distance from the headboard or footboard to prevent entrapment. This hazard is addressed by requiring labeling on the APBR to state the appropriate distance between an installed APBR and the headboard or footboard of the bed. Section 9.1 also specifies that all on-product labels must be permanent.

Section 9.2 establishes requirements for warning statements that must appear on the APBR and its retail packaging, instructions, and digital or print advertising. The warning statements must be easy to understand, and any other labels or written instructions provided along with the required statements cannot contradict or confuse the meaning of the required warnings or otherwise be misleading.

Section 11 specifies requirements for instructional literature that must accompany APBRs. The instructions provided must be easy to read and understand; include assembly, installation, maintenance, cleaning, operation, and adjustment instructions and warnings, where applicable; include drawings or diagrams to provide a better understanding of set up and operation of the product; include drawings that depict all the entrapment zones; and include all warning statements specified in section 9.2, including warnings about product damage or misalignment.

Although requirements for labeling, warning, and instructional requirements are less effective at reducing hazards than product designs that directly address known hazards, these requirements in the standard improve safety by addressing risks that may not be eliminated through design.

Although many provisions of ASTM F3186-17 do improve safety, for the reasons discussed in section V. of the preamble of the NPR, the Commission determines that, without additional modifications, the voluntary standard is insufficient to eliminate or adequately reduce the unreasonable risk of injury of entrapments from APBRs.

Staff conducted two rounds of market compliance testing to ASTM F3186-17: the first round in 2018 and 2019, the second round in 2021. In both rounds, no APBRs met all requirements of ASTM F3186-17. All products failed at least one critical mechanical requirement, such as retention strap performance, structural integrity, and entrapment. As described in Tabs C and D of the staff's NPR briefing package and the staff's final rule briefing package, an APBR that fails any one mechanical performance requirement could result in a fatal entrapment. Furthermore, all products failed the labeling, warning, and instructional requirements. This section discusses market compliance with ASTM F3186-17.

From 2018 through 2019, staff of CPSC's Directorate for Laboratory Sciences, Division of Mechanical Engineering, tested 35 randomly selected APBR models for compliance with ASTM F3186-17. That voluntary standard became effective in August 2017. APBRs were purchased in 2018. Staff found that none of the 35 sampled products conformed to the voluntary standard. As shown in Table 8 below, compliance varied depending on the relevant section of the voluntary standard. Overall, 33 APBR models did not meet the entrapment performance requirements, and none of the 35 models met the labeling, warnings, or instructional literature requirements.

Of the 35 APBR models staff tested, 33 failed at least one of the entrapment requirements for the four different zones in and around the APBR. In other words, 94 percent of samples had at least one major zone where a body part could be entrapped. Furthermore, many samples failed the entrapment requirements in multiple zones: 14 failed the Zone 1 entrapment requirement; 27 failed Zone 2; 11 failed Zone 3; and 6 failed Zone 4.

Testing conducted by staff also revealed high failure rates for several other sections of the ASTM standard, including the retention system requirements (28 of 35 samples), and structural integrity requirements (15 of 35 samples). These types of failures indicate that the product may not stay rigidly in place after installation and will not adequately support the consumer during normal use conditions, such as leaning against the product. Not meeting these requirements thus significantly increases the likelihood of entrapment and fall hazards.

Retention system failures occurred when components were not permanently attached to the product, the retention strap permanently deflected or detached during the free end pull test, 12 or the retention system did not restrain the product during entrapment testing. Structural integrity failures occurred when the APBR did not extend at least 4 inches over the top of the thickest recommended mattress, or when fasteners loosened or detached during testing, causing the product to change dimensions.

All 35 models failed the labeling, warning, and instructional literature requirements. None of the 35 models fully met the following requirements: section 9.1 for retail packaging and product labels; section 9.2, which specifies that warning statements must appear on the product, its retail package, and its instructions; and section 11's requirement to include instructional literature with required warning statements. None of the samples adequately instructed consumers how to safely install the APBR; nor did the samples adequately inform consumers of the known hazards related to APBRs. Detailed testing results are provided in Appendix A of the staff's NPR briefing package.

In 2021, staff conducted a second round of product testing to ASTM F3186-17 to determine if the additional time and outreach efforts by staff since 2018 were sufficient for manufacturers to increase their overall level of compliance to the standard. A representative total of 17 APBR products were procured for testing: these included all of the eight APBR models that staff identified as new to the market since the 2018 analysis, and nine additional, randomly selected models from the remaining models available in the market. The nine randomly selected models were products previously identified in the 2018 analysis as available for purchase at that time and were again included in 2021 to account for any changes to those models that may have improved their compliance to the voluntary standard.

The 2021 testing, like the 2018 analysis, was designed to assess overall compliance to the voluntary standard, with a focus on certain sections of ASTM F3186-17 including Retention Systems, Structural Integrity, Entrapment, Openings, Misassembled Products, Warning Statements, and Instructional Literature. All 17 samples failed at least one of these performance requirements. Detailed testing results are provided in Appendix B of the staff's NPR briefing package. Because performance testing of a sample was stopped after failing to meet at least one performance requirement, the data collected may not account for all the potential nonconformities for each product.

Additionally, none of the 17 models met the labeling, warnings, and instructional literature requirements. As shown in Table 9 below, the failure modes of this analysis are similar to those in the 2018 analysis, indicating little-to-no significant change in the market over this time.

CPSC has issued five public warnings regarding specific APBRs that did not comply with ASTM F3186-17. In April 2021, CPSC warned consumers to stop using three models of APBRs manufactured by Bed Handles, Inc., because the products pose an entrapment hazard. 13 Bed Handles, Inc., manufactured approximately 193,000 units of the bed rails, and CPSC is aware of four entrapment deaths associated with the product.

In December 2021, CPSC announced voluntary recalls of APBRs manufactured by three firms, due to the entrapment hazard and risk of death by asphyxia posed by their products:

• Drive DeVilbiss Healthcare (496,100 units, 2 deaths);  14

• Compass Health Brands (104,900 units, 3 deaths);  15 and

• Essential Medical Supply, Inc. (272,000 units, 1 death). 16

In June 2022, CPSC warned consumers to stop using 10 models of APBRs manufactured and sold by Mobility Transfer Systems, Inc. from 1992 to 2021, and by Metal Tubing USA, Inc. in 2021 and 2022. Three entrapment deaths involving one of these models have occurred. 17 Neither of the two manufacturers agreed to conduct a recall. Approximately 285,000 units were manufactured.

The Commission determines that, without additional modifications as discussed in the NPR and below, the voluntary standard is insufficient to eliminate or adequately reduce the unreasonable risk of injury of entrapments presented by APBRs. Moreover, based on staff's test results showing that there is no market compliance with the voluntary standard, the Commission determines that substantial compliance to a voluntary adult portable bed rail safety standard is unlikely. Accordingly, the Commission rule incorporates by reference, ASTM F3186-17 with modifications, to require ABPR manufacturers to comply with the fundamental requirements of the mandatory standard and thereby improve safety.

CPSC received seven written comments during the NPR comment period. The comments are available on: www.regulations.gov, by searching under docket number CPSC-2013-0022. For more details about the comments CPSC received on the NPR, see the final rule staff briefing package. This section describes key issues raised in the comments and CPSC's responses to them.

Comments: Four commenters addressed the issue of banning APBRs. Public Citizen urged the CPSC to withdraw its proposed rule and instead promulgate a rule under section 8 of the CPSA, declaring all currently marketed adult bed rails to be banned hazardous products. National Center for Health Research (NCHR), National Consumer Voice for Quality Long-Term Care (Consumer Voice), and California Advocates for Nursing Home Reform (CANHR) commented that they do not support a ban at this time. However, they stated that they would support a ban on APBRs if the final rule is adopted and proves to be ineffective in preventing deaths and injuries resulting from APBR entrapment.

Response: At this time there is not sufficient evidence to support a ban on APBRs under section 8 of the CPSA. Under section 8 of the CPSA, to issue a ban, the Commission must find:

• a consumer product is being, or will be, distributed in commerce and such consumer product presents an unreasonable risk of injury; and

• no feasible consumer product safety standard under this Act would adequately protect the public from the unreasonable risk of injury associated with such product.

Comment: Gloria Black, NCHR, Consumer Voice, Public Citizen, and CANHR identified several alternatives to using APBRs, such as: bed trapezes, adjustable beds, non-slip mattress pads, bed exit alarms, body pillows, and medical attendees. 18 Gloria Black specifically identified “no cost options” including lowering the bed or placing the mattress on the floor to prevent falls, placing cushioning on the floor to prevent serious injury, and placing a sturdy nightstand or table next to the bed to assist individuals in getting in and out of bed. Additionally, CANHR stated that APBRs are “used primarily as physical restraints for the convenience of others, and almost always unnecessary and in nursing homes” and per “the Nursing Home Reform Law of 1987's prohibition of physical restraints for the convenience of staff, safe alternatives to prevent injury from falls have been practiced for decades in compliant facilities.”

Two comments addressed the qualitative or quantitative value of APBRs. Sarina Martin expressed a general concern that a ban on APBRs will increase the risk of falls in long-term care facilities. Consumer Voice was unaware of any qualitative or quantitative evidence concerning the utility that APBRs have for consumers relative to products that might be used as substitutes in the event APBRs are banned. However, Consumer Voice noted some consumers have expressed fears that a ban could limit their ability to leave their beds, lead to a decline in mobility and functioning and therefore increase their dependency, and result in decreased quality of life due to greater isolation.

Response: A ban on APBRs could leave consumers without a product that provides them with mobility and independence. APBR products help consumers by aiding them in safely staying in a bed and providing them with a safe grip for getting in/out of a bed and repositioning while in bed. Such products are particularly useful for consumers who live in a personal residence, rather than in a hospital or care facility, as supervision or assistance may be less readily available in a home environment. However, considering the number of fatal and non-fatal injuries from APBRs, the Commission considers the requirements for APBRs in the final rule to be necessary to address the risks. Consumers may choose to use alternatives to APBRs, but while these alternatives have been available to consumers, many injuries and deaths continue to occur. These alternatives alone have not adequately reduced the unreasonable risk of injury and death presented by APBRs, and thus the final rule is needed to address the identified hazards.

Comment: Sarina Marlin expressed a general concern regarding the effect of the proposed rule on long-term care facilities. Ms. Marlin asserted that data from staff's NPR package indicates that a disproportionate number of recorded fatalities associated with APBRs occur in home settings when compared to Long Term Care Facilities.

Response: The fatality location ratios quoted by Ms. Marlin are drawn from the preamble of the NPR, in which staff identified 158, 50, 40, and 14 fatalities associated with APBR entrapment in homes, nursing homes, assisted living facilities, and residential institutions, respectively. Without knowing the level of exposure in these different treatment settings, one cannot infer that there are fewer fatalities per APBR in professional settings than in the home, or that APBRs in professional settings do not pose significant risk to the public, without knowing the number of APBRs in use in each setting. CPSC staff did not, and does not, possess this information nor data from which estimates of the number of APBRs in use in each setting may be drawn. No such information was submitted by the commenter. However, given that APBRs are marketed primarily to individual consumers, staff assesses that APBRs are more likely to be found in homes than in professional settings. 19

The Commission disagrees with the commenter's assertion that an undue impact will occur to long term care facilities. In the NPR's Preliminary Regulatory Analysis, CPSC staff considered the effect of the proposed rule on APBR price, the dead weight loss (the lost consumer and producer surplus resulting from price-induced decrease in APBR sales) associated with the price change, cost, and net benefits. Staff estimated the proposed rule would increase manufacturer costs in the first year by approximately $5.40 per APBR, of which $4.00 is expected to be passed on to APBR consumers (including commercial enterprises) in the form of higher prices. A $4.00 increase in APBR price represents less than 0.01 percent of the annual cost of a private room in an assisted living facility, and approximately half that already tiny percentage for a private room in a nursing home, which staff does not consider an undue burden for these facilities. 20

Comment: Louis A. Ferreira, of Stoel Rives, LLP, representing Stander, Inc. (Stander), a seller of APBRs, suggests that the NPR's proposal to regulate the sizes of holes or slots that extend entirely through a wall section on an APBR is not reasonably necessary to prevent or reduce an unreasonable risk of injury. Stander disagreed with the Commission's proposal to make the opening requirements consistent with standards for other products such as Children's Portable Bed Rails and instead suggests that the final rule should only correct consistency errors concerning dimensions in section 6.4 of the voluntary standard. Stander claimed that “the size of the holes do[es] not increase the risk of a fall of entrapment” and that “[t]here is not even evidence in the record that would support a conclusion that finger entrapment in the holes of an adult bed rail have ever caused an injury.”

Response: As reported in Tab A of the staff briefing package for the NPR, about 7,400 of the estimated 79,500 adult bed rail-related injuries treated in emergency departments from 2003 to 2021 were hand or finger injuries. Of these, about 3,400 were identified as injuries to fingers, most of which involved crushing or laceration. 21

Section 6.4 of ASTM F3186-17 addresses the risk of finger entrapment and laceration in small holes or openings. Changes to this section are necessary to correct errors and inconsistent measurement references. Specifically, in stating the dimensions of the rods used to conduct testing, the standard inaccurately refers to 13 mm as the equivalent to 5/8 in. (whereas 5/8 in. is approximately 16 mm). Also, while the standard allows different dimensions for holes or slots that do not exceed 1/4 in. in depth, it refers to a drawing depicting a hole up to “.375 (9.53 mm) deep,” or 3/8 in., shown below in Figure 2.

Further, the proposed changes in the NPR are necessary to adequately address the risk of injury because the hole dimensions referenced by the commenter are not effective in protecting vulnerable adult populations. Vulnerable adults are often smaller and more frail than other populations of adults and are more likely to use APBR products. The proposed changes in the NPR align the rule with other established children's product regulations that prevent hazards to a range of finger sizes that covers both children and adult users simultaneously. 22

The Commission therefore concludes the language proposed in the NPR is necessary to address the range of foreseeable consumer exposures to potentially hazardous holes in APBRs. Therefore, no change will be made to the final rule based on this comment.

Comment: Luis A. Ferreira, representing Stander, suggested that staff's proposed entrapment test modifications are ambiguous and inadequate. Stander expresses concern “that the ASTM Standard with the proposed modifications could be misinterpreted, and a product fail the test, not because of any unreasonable risk posed by the bed rail, but simply because a mattress is selected for testing that is so soft that the probe can be pulled beneath the bottom rail of the APBR.” Stander suggests making changes to the proposed entrapment test requirements of the NPR.

Response: ASTM F3186-17 does not have a specific definition for “entrapment zone.” Based on the commenter's interpretation of the entrapment test methods, the voluntary standard may not adequately describe what an entrapment zone is and why it is tested.

Each entrapment zone test addresses specific hazard patterns that are identified in both the FDA guidance document as well as staff's findings from the incident data. The hazard patterns associated with each entrapment zone are described below.

• Zone 1 testing addresses head-first entry into fully bounded openings within the structure of the rail.

• Zone 2 testing addresses head-first entry under the rail into any opening between the mattress compressed by the weight of a consumer's head and a section of the bedrail longer than 4.7 in.

• Zone 3 testing addresses entry of the head into a gap between the inside surface along the length of the rail and the mattress compressed by the weight of a consumer's head.

• Zone 4 addresses neck-first entrapment between the rail and mattress compressed by the weight of a consumer's head and neck at the ends of the rail.

We disagree with Stander's interpretations that entrapment zone hazards only exist where there are visible openings. According to the CPSC staff's analysis of the incident data, the area “between the rail and mattress” is the most common location for entrapment. The hazards related to each zone are present regardless of the locations of the supports but are dependent on the design of the rail in relation to the anthropometric dimensions of the user.

For example, per Zone 2, the known hazard is head-first entry under the rail in any section longer than the anthropometric head dimension of the entrapment test probe, which is 4.7 inches. Therefore, in Figure 3 below, both the left and right areas should meet Zone 2 requirements, in addition to the other applicable tests, to ensure the product adequately addresses the known hazard.

Safety testing should represent known hazard modes, including the displacement caused by consumers moving or pushing into the mattress or product, which may create an opening that was not previously visible. During entrapment zone testing, the positioning and application of the force via a force gauge must be realistic and representative of all reasonably foreseeable scenarios of consumer behavior. In many cases, applying the force to the probe by attaching a force gauge below the bottom of the rail is the most accurate representation of the worst case of this foreseeable hazard scenario. Additionally, in contrast to the current voluntary standard, entrapment hazards are not present only in the “largest opening” of a product. Entrapment hazards may exist in several areas depending on the product configuration and installation.

To ensure entrapment hazards are adequately addressed, products must be assessed in all areas that may constitute an entrapment zone. Therefore, in response to this comment, the Commission has revised the language in the final rule as follows:

• Adding a global definition for “entrapment zone” to the draft rule, which will clarify what areas must be tested.

• Removing language from the test methodology that may have led test personnel to unnecessarily restrict locations and orientations of the placement of the entrapment test probe for testing.

• Improving instructions for test personnel to apply forces in a manner that is more representative of the entrapment hazards.

Comment: Louis A. Ferreira, representing Stander, suggests that the proposed addition of section 7.1.3 of the NPR's proposed rule to the voluntary standard's requirements is not reasonably necessary to prevent or reduce an unreasonable risk of injury. Staff's proposal for this additional section would allow testers to select for testing a mattress that is up to 1.5 in. (38 mm) thicker or thinner than the range specified by the manufacturer. Standard asserts that “there is no evidence in the record that a consumer has ever suffered an injury because they used an adult bed rail on the wrong size mattress.”

Response: Mattress thickness has a direct bearing on the entrapment hazard. ASTM F3186-17 defines Zones 2, 3, and 4 in relation to the product and the mattress. A mattress that is too thin can result in larger entrapment zones, posing a greater risk of entrapment. On the other hand, an APBR used with a mattress that is too thick can lead to an APBR failing to meet the standard's structural integrity performance requirement, found in section 6.2, which states that the top of the bed rail must extend 4 inches above the mattress.

Staff has found that most APBR models can be installed and adjusted regardless of mattress thickness, and the hazard created by using an APBR on an incompatible mattress will not be apparent to the typical consumer. Therefore, it is preferable to design out hazards rather than rely on consumers to follow warnings and instructions.

Indeed, it is foreseeable that some consumers will use APBRs with mattresses that are not within the manufacturer's recommended thickness range. During APBR testing, staff found that a mattress's true thickness typically differs from the thickness advertised by the mattress manufacturer. Consumers are unlikely to measure their mattress prior to purchasing an APBR, or they may not measure it accurately. Additionally, consumers may not have information about the mattress thickness when they purchase APBRs for use by another person, or for use on a hotel or guest bed. Finally, consumers who transfer existing APBRs to a new mattress may not take any action to ensure that the APBR is appropriate for the new mattress's thickness.

The mattress thickness variability requirements in the final rule anticipates these and similar foreseeable scenarios. The requirement covers a limited range of mattresses beyond what is advertised to account for the known hazards outside of the “compatible” range.

Comment: Consumer Voice notes that language in the proposed modifications to the voluntary standard could potentially allow manufacturers to avoid providing consumers a recommended mattress thickness range for their products. Consumer Voice requested removing this language from the final rule.

Response: The Commission agrees with Consumer Voice. Section 9.1.1.3 of the voluntary standard requires manufacturers to list a recommended thickness range. The final rule will remove “If the manufacturer does not recommend” and other related language from the proposed additions to sections 6.2.1 and 7.1 of the voluntary standard to avoid manufacturers potentially not providing consumers a recommended mattress thickness range for their products.

Comment: Consumer Voice requested staff ban the use of straps as a means of attaching the product to a bed. Consumer Voice asserts that the use of straps to attach an APBR to a bed greatly increases the risk of improper assembly and the likelihood of harm, and that straps can stretch and become loose over time.

Response: Banning retention straps would unnecessarily restrict APBR designs. The proposed modifications to the requirements of the standard, such as the requirement for a warning on an “installation component,” will adequately address known hazards associated with APBRs and increase the likelihood of consumers installing the retention strap. CPSC staff has not identified any strangulation or other hazards specifically associated with retention straps, and therefore there is not sufficient evidence to support banning retention straps.

Comment: Consumer Voice expressed concerns that the proposed definition of “conspicuous,” adopted from section 3.1.3 of the voluntary standard, is too narrow. Consumer Voice suggests modifying the proposed definition in the voluntary standard to increase the requirements for visibility of warning labels on the product. Specifically, Consumer Voice recommends that the definition be revised so that “conspicuous” labels/components be visible to both the consumer and a person standing near the unit from at least two different positions.

Response: The definition of “conspicuous” in section 3.1.3 requires certain labels to be visible from one position rather than 2 positions, as proposed by the commenter. The commenter's recommended alternative definition does not provide sufficient guidance regarding the two positions in which warning labels would be required to be visible, and it could foreseeably be interpreted such that two viewing positions are only marginally different. Therefore, the commenter's proposed definition of “conspicuous” does not represent a substantive improvement to safety.

Comment: Consumer Voice recommended that the term “conspicuous” should not be deleted from the warning label placement requirements in section 9.2.7, as proposed in § 1270.2(b)(18)(i) of the NPR. Consumer Voice claimed the removal of the word would weaken the requirement and make the product less safe.

Response: The warning in section 9.2.7 of ASTM F3186 is directly related to product installation. As discussed in the NPR briefing package, the warning should draw attention to the installation component and encourage its use during installation (16 CFR part 1224, the children's bed rail standard, has this same warning requiring it to be on an “installation” component). Therefore, it is unnecessary for the warning on the product to be conspicuous in the manufacturer's recommended use position. Additionally, ASTM F3186-17 requires separate warnings that address entrapment hazards and securing the APBR to the bed that are required to be placed on a conspicuous component of the product and/or packaging/instructions. Therefore, the warning in section 9.2.7 should be on an installation component but is not required to be conspicuous for the reasons discussed above.

Comment: Consumer Voice requested an additional requirement that manufacturers provide consumers with records of compliance testing upon request.

Response: Manufacturers and importers of APBRs will be required to issue a General Certificate of Conformity (GCC) under section 14 of the CPSA and 16 CFR part 1110 for the APBR mandatory standard. A GCC requires manufacturers or importers to certify that their general use products comply with all applicable consumer product safety rules (or similar rules, bans, standards, or regulations) under any law enforced by the Commission for that product. A GCC must accompany the applicable product or shipment of products covered by the certificate. A manufacturer or importer must furnish the GCC to distributors or retailers. Based on the available information there is not significant evidence indicating that the commenter's proposed requirement that manufacturers also provide records of compliance testing directly to consumers will substantially decrease the known hazards related to APBRs given the existing GCC framework.

Comment: Consumer Voice argued that the labeling and warning requirements for retail packaging, instructions, and the product labels set out in the proposed rule are confusing and contradictory. Consumer Voice specifically suggested reorganizing the labeling requirements.

Response: We do not agree with Consumer Voice's proposed change to the proposed rule. The current requirement in ASTM F3186-17, which is included in the final rule, clearly states the required location for each warning.

Comment: Consumer Voice suggested adding labeling requirements to include information about the intended use of APBRs and for whom the products are designed.

Response: APBR manufacturers should specify how their product(s) function in their instructions and on their product packaging. However, staff's familiarity with existing ABPRs' marketing, packaging, labeling, and appearance leads staff to assess that consumers are likely to understand that the products are designed for elderly users and/or adult users with disabilities/inhibited movement, so the Commission finds that additional recommended labeling is unnecessary.

Comment: Consumer Voice argues that email is an increasingly used form of communication, and including an email will make contacting manufacturers more accessible for consumers. Consumer Voice requests that the final rule should require manufacturers to include their email address in addition to the other contact information currently required.

Response: The required contact information already in the standard is adequate for consumers to contact the manufacturer. We do not have any evidence indicating that requiring an email address will decrease known hazards related to APBR products.

Comment: Consumer Voice suggests adding to the language throughout the final rule's warning statements, specifically by including a discussion of the risk of “serious injury or death from entrapment.”

Response: Each warning clearly states that improper use and/or installation can lead to entrapment and death. Therefore, no change to the final rule is necessary based on this comment.

Comment: Consumer Voice recommends requiring manufacturers to include drawings in the instructions that depict potential examples of entrapment to allow consumers to better understand the potential hazards of APBRs.

Response: Section 11.1 of the APBR voluntary standard, ASTM F3186-17 includes a similar requirement and is incorporated by reference in the final rule. Manufacturers are required to include drawings of all entrapment zones (Zones 1-4). The FDA drawings are provided as a reference in Appendix X1.1 but manufacturers are free to use their own illustrations should they choose to do so.

Comment: Consumer Voice and CANHR, submitted comments in favor of the stockpiling provision proposed in the NPR. No comments objecting to the proposed stockpiling provision were submitted. Therefore, the prohibition on stockpiling will be finalized as proposed.

Comments: Three commenters submitted comments regarding the effective date. Consumer Voice and CANHR were in favor of the 30-day effective date. Louis A. Ferreira, representing Stander, urged that the rule should not prohibit Stander from selling existing stock of APBRs that are compliant with the ASTM F3186-17 standard.

Consumer Voice considered the 30-day effective date to be appropriate and fair, and stated that “manufacturers should not need more than 30 days.” They also commented that the ASTM standards went into effect in 2017 and that “[f]ive years is more than enough time to understand the standards and take the steps necessary to comply.” CANHR “support[ed] the staff's recommendation not to issue the new rule with an introduction time more than 30 days” while also noting that the ASTM voluntary standard has been available to manufacturers and other interested parties since 2017.

Stander states, “Stander has made a significant investment to produce product consistent with the existing ASTM Standard” and “it would require a least a year to sell its existing stock that is compliant with the existing ASTM Standard but not the modified ASTM Standard.” Stander further states that “[a]s the CPSC has found that the compliance with the existing ASTM Standard is sufficient to eliminate the `unreasonable' risks posed by APBRs, CPSC should expressly allow manufacturers a reasonable period of time to sell existing stock that complies with the current ASTM Standard.” Stander “believes that a reasonable period to sell its ASTM Standard compliant stock would be one year.”

Response: No commenter contends that a 30-day period is insufficient for manufacturers to come into compliance with the final rule. However, Stander expressed concerns regarding selling their existing stock of APBRs. The final rule does not prohibit Stander from selling its existing stock that was manufactured before publication of the final rule in the Federal Register .

Finally, for clarity, we disagree with Stander's claim that “the CPSC has found the compliance with the existing ASTM Standard is sufficient to eliminate the `unreasonable' risks posed by APBRs.” In the NPR, the Commission preliminarily determined that the combined requirements of the voluntary standard—with the proposed modifications that were deemed necessary—would adequately reduce unreasonable risk and injury associated with APBR entrapment. 87 FR 67586. The Commission did not find the voluntary standard by itself sufficient to address the unreasonable risk posed by APBRs. That approach is unchanged for the final rule.

The Commission determines that ASTM F3186-17, with modifications to improve safety, will address all known product hazard modes associated with APBRs, particularly entrapment. The provisions of the final rule are described below.

Section 1270.1 provides that new part 1270 establishes a consumer product safety standard for APBRs manufactured after the effective date of the final rule. This section is being finalized as proposed.

Section 1270.2 of the final rule sets forth the requirements for APBRs. Section 1270.2(a) requires each APBR to comply with all applicable provisions of ASTM F3186-17. Section 1270.2(a) is being finalized as proposed.

Section 1270.2(b) provides the requirements for APBRs in addition to those based on ASTM F3186-17. Most of the requirements of § 1270.2(b) are being finalized as proposed in the NPR. Detailed descriptions and justifications for the proposed requirements can be found in the preamble of the NPR and the staff briefing package for the NPR. Several provisions of proposed § 1270.2(b) have been revised in the final rule in response to comments. For additional information regarding the comments that resulted in changes to the final rule and a detailed summary of the comments and responses see section V. of this preamble and the staff briefing package for the final rule. Below is a description of the changes made from the proposed rule to the final rule. In addition to the changes described below to the final rule, non-substantive conforming, editorial edits, and changes to numbering and cross references were made in the final rule for consistency and accuracy.

A comment from APBR seller Stander indicated that the proposed rule is ambiguous regarding the testing of entrapment zones. ASTM F3186-17 does not define the term “entrapment zone.” The preamble of the NPR referenced both the FDA guidance document and incident data to explain how the entrapment zones will be identified, and the different ways entrapment can occur within the entrapment zones. However, adding a global definition for “entrapment zone” to the final rule will clarify what areas must be tested. Therefore, § 1270.2(b)(1)(i) of the final rule includes a new definition for “entrapment zone,” which is defined as “An area, gap, or opening that can potentially capture or restrain a person's body part. Hazardous openings may not always be visible prior to testing.” The three original definitions in proposed § 1270.2(b)(1) have been renumbered from proposed § 1270.2(b)(1)(i) through (iii) to § 1270.2(b)(1)(ii) through (iv) in the final rule to account for the addition of the new definition of entrapment zone in § 1270.2(b)(1)(i) of the final rule.

Based on Stander's comment that recommended revisions to the proposed language for mattress thickness selection, the Commission is removing from § 1270.2(b)(3)(i) of the final rule language that could be interpreted as exempting manufacturers from including a range of compatible mattress thicknesses, which is contradictory to the intent of the standard.

A comment from Consumer Voice was submitted indicating that the original proposed language seems to create an alternative requirement for manufacturers that do not provide a recommended thickness range, as required by section 9.1.1.3 of the voluntary standard. Based on the comment, § 1270.2(b)(8)(i) of the final rule adds an additional range that will increase safety by accounting for foreseeable differences between nominal and actual mattress thicknesses, as well as consumer mattress selection that deviates from manufacturer recommendations.

Proposed § 1270.2(b)(9) contained the introductory instruction of “In addition to complying with section 7.2 of ASTM F3186-17”, when it should have read “Instead of complying with section 7.2 of ASTM F3186-17”. The final rule has been revised to correct this error.

Based on a comment from Stander, the language in proposed § 1270.2(b)(11)(i) and (b)(13)(i) has been revised in the final rule to remove restrictions on how the probe and force should be applied, and thereby better represent the known hazard patterns and ensure consistent interpretations of the test methods. Applying the force perpendicular to the 2.4-inch end of the probe may not always emulate the potential hazard of head or limb entrapment. Therefore, the language in § 1270.2(b)(11)(i) and (b)(13)(i) of the final rule has been revised to “in the direction most likely to lead to failure of the requirement” to make it clearer and more easily understood by safety testing personnel.

Also based on a comment from Stander, § 1270.2(b)(12)(i) has been revised in the final rule to remove restrictions on how the probe and force should be applied to better represent the known hazard patterns. The language in § 1270.2(b)(12)(i) of the final rule has been revised to read “at the angle most likely to allow it to pass through” to make it clearer and more easily understood by safety testing personnel.

The requirements of proposed § 1270.2(b)(13)(ii) in the NPR have been renumbered as revised § 1270.2(b)(14) in the final rule. Therefore, proposed § 1270.2(b)(14) through (19) have been renumbered as § 1270.2(b)(15) through (20) in the final rule. Revised § 1270.2(b)(14) has been modified from the proposed rule because proposed § 1270.2(b)(13) introductory text incorrectly stated that the language “Instead of complying with [the applicable ASTM provision]” applied to both § 1270.2(b)(13)(i) and (ii). The introductory instructional text for proposed § 1270.2(b)(13)(ii) should have read “In addition to complying with [the applicable ASTM provision]”. Therefore, in the final rule, § 1270.2(b)(14) has been revised to provide the correct introductory text.

Additionally, § 1270.2(b)(14)(i) in the final rule has been revised from proposed § 1270.2(b)(13)(ii). Stander raised concerns about the location of Zone 2 on bed rails with multiple supports. Zone 2 testing is meant to address head-first entry under the rail into any opening between the mattress compressed by the weight of a consumer's head and a section of the bedrail. Bed rails that have overhanging elements longer than 4.7 inches can allow the passage of the head in a manner consistent with identified Zone 2 entrapment hazards regardless of the number or location of vertical support rails. 4.7 inches is the diameter of the test probe and encompasses the 5th percentile female head breadth. Therefore, revised § 1270.2(b)(14)(i) clarifies which areas should be included in Zone 2 testing along with adding a new figure 1 illustration that visually depicts the clarifying language.

In the NPR, the Commission proposed an anti-stockpiling provision to prevent firms from manufacturing large quantities of non-compliant APBRs before the rule takes effect. This section makes it a prohibited act, for the period of time between the date of Federal Register publication of the final rule and the effective date of the final rule, for manufacturers and importers to manufacture or import APBRs at a rate that is greater than 105 percent of the rate at which they manufactured or imported APBRs during the base period of sales for the manufacturer or importer. The prohibited stockpiling provision is being finalized as proposed.

The findings required by section 9 of the CPSA are discussed throughout the preamble of this rule and set forth in appendix A to part 1270. While the findings have updated for the final rule, they are substantively the same as the proposed findings in the NPR.

Pursuant to section 9(f)(2) of the Consumer Product Safety Act, publication of a final rule must include a final regulatory analysis containing:

• A description of the potential benefits and potential costs of the rule, including any benefits or costs that cannot be quantified in monetary terms, and an identification of those likely to receive the benefits and bear the costs.

• A description of any alternatives to the final rule which were considered by the Commission, together with a summary description of their potential benefits and costs and a brief explanation of the reasons why these alternatives were not chosen.

• A summary of any significant issues raised by the comments submitted during the public comment period in response to the preliminary regulatory analysis, and a summary of the assessment by the Commission of such issues.

Since the publication of the NPR in the Federal Register on November 9, 2022, the Commission has not identified any material changes in the APBR market, or in the data used in the preliminary analysis of benefits and costs. Though some of the comments on the NPR described possible economic impacts of the rule, none of the comments specifically addressed or otherwise suggested changes to the preliminary regulatory analysis. Therefore, the final regulatory analysis for the final rule discussed below is substantively unchanged from the analysis described in the preamble of the NPR and in Tab G of the staff NPR briefing package, as explained in Tab C of the final rule briefing package.

CPSC's assessment of the final rule's potential benefits and costs is that the quantifiable benefits of the rule are in the range of $66.75 million per year (assuming a 25% efficacy rate for the rule's requirements) to $200.24 million per year (assuming a 75% efficacy rate). The costs associated with the rule's requirements to prevent the hazards associated with APBRs are expected to be $2.01 million per year. On a per product basis, the benefits of the final rule are estimated to be between $110.59 per APBR (25% efficacy) and $331.78 per APBR (75% efficacy), and the costs are estimated at $3.34 per APBR. All these amounts are in 2021 dollars using a discount rate of 3 percent. The Commission's analysis is based on incident reports for entrapments, only. Although APBRs may have been involved in other deaths or injuries, such as falls, those incidents are not considered in the benefit-cost analysis because there are limited details involving such incidents, and it is unclear what percentage, if any, of fall incidents would be prevented by the final rule.

The expected benefits and costs of the final rule are discussed below. The most common hazard pattern among all reported incidents is rail entrapment, accounting for more than 90 percent (284 of 310) of the fatal incidents. CPSC uses the period 2010 through 2019 for its rates of fatalities because, at the time of the NPR, it was the most recent 10-year window where all or nearly all incidents have been reported. The NPR identified 158 deaths from entrapment that occurred from 2010 through 2019. This number accounts for 92 percent of observed death incidents; the remaining 8 percent were caused by underlying incidents that may or may not be prevented by the final rule. To forecast entrapment deaths into the future, CPSC used death rates per million APBRs in conjunction with its forecast of APBRs in use throughout the study period. The NPR assumed deaths would stay the same as the average rates observed between 2010 to 2019: 31.9 deaths per million APBRs.

To estimate the societal costs of entrapment deaths, CPSC applies the value of statistical life (VSL). VSL is an estimate used in benefit-cost analysis to place a value on reductions in the likelihood of premature deaths. The VSL does not place a value on individual lives, but rather, it represents an extrapolated estimate, based on the rate at which individuals trade money for small changes in mortality risk. CPSC specifically applies the estimate of the VSL developed by the U.S. Environmental Protection Agency (EPA). The EPA estimate of the VSL, when adjusted for inflation, is $10.5 million in 2021 dollars. CPSC multiplies the VSL by the number of forecasted deaths throughout the study period to calculate societal costs of deaths from entrapment in the absence of the final rule.

We further assume that the number of firms and ABPR models in use will tend to be stable in future years around the values in 2022: 12 firms and 65 models. The market for APBRs is expected to grow at an average rate of 2.01 percent per between 2024 and 2053 as a result of an aging U.S. population. Assuming the rate of incidents per million APBRs stays constant, an industry of this size would result in an average of 32 deaths from entrapment per year. At a VSL of $10.5 million (2021 dollars), the annualized present value of the potential benefits of the final rule is $298.11 million.

The Commission has not included non-fatal injuries in the foregoing benefit-cost assessment because for many incidents involving such injuries, there is not sufficient information to determine whether they would be prevented by the final rule. However, non-fatal injuries have been quantified and monetized in a sensitivity analysis as a potential upper limit to assess the benefits of this final rule. Further, the requirements of the final rule are expected to address the 92 percent of deaths caused by entrapment. However, because we do not assume the final rule will eliminate all deaths caused by entrapment, we assessed potential benefits for the final rule under three scenarios, estimating benefits at 75 percent, 50 percent, and 25 percent of the 92 percent baseline efficacy.

At these rates under varying conservative assumptions ( i.e., likely to underestimate the benefits of the rule), CPSC estimates the annualized benefits of the final rule to be $200.24 million, $133.49 million, and $66.75 million, respectively. As discussed below, annualized costs associated with the final requirements to prevent APBR hazards are estimated to be approximately $2 million. This results in net quantifiable benefits of $198.23 million, $131.48 million, and $64.74 million on an annualized basis under these various scenarios that assume reduced benefits. Table 10 summarizes the projected benefits of the final rule.

The Commission's regulatory assessment of the costs of the final rule assumes that 100 percent of manufacturers will fully redesign their APBR models to comply with ASTM F3186-17, with the final rule's modifications. Like the benefits estimation, the time span of the cost analysis covers a 30-year period that starts in 2024, which is the expected year of implementation of the final rule. This cost analysis presents all cost estimates in 2021 dollars. This cost analysis also discounts costs in the future and uses a 3 percent discount rate to estimate their present value.

The cost of implementing APBR requirements to address entrapment hazards includes the costs manufacturers incur to redesign existing models and produce new designs to comply with the final rule, as well as any additional cost of producing the APBR that is associated with its redesign. Manufacturers would likely incur expenditures in design labor, design production, design validation, and compliance testing. CPSC staff's review indicates that once existing models have been redesigned with a working solution, new models can adapt the solution at a minimal cost.

Manufacturers can transfer some, or all, of the increased production cost to consumers through price increases. In the first year, the Commission expects producer manufacturing costs to increase by $5.40 per APBR, of which $4.00 per APBR is expected to be passed on to the consumer in the form of higher prices. At the margins, some producers may exit the market because their increased marginal costs now exceed the increase in market price. Likewise, a fraction of consumers would now probably be excluded from the market because the increased market price exceeds their personal price threshold for purchasing an APBR. Deadweight loss is the measure of the losses faced by marginal producers and consumers who are forced out of the market due to the new requirements of the final rule. Table 11 summarizes the projected costs of the final rule:

Table 12 displays net benefits (difference between benefits and costs) and the benefit-cost ratio (benefits divided by costs) to assess the cost-benefit relationship of the final rule. The table displays these metrics using annualized benefits for the three scenarios: 75 percent, 50 percent, and 25 percent efficacy rates. These metrics show the draft final rule's benefits well exceed costs in each scenario.

I. Legal Authority

On July 22, 2016, the President signed the Comprehensive Addiction and Recovery Act (CARA) of 2016 into law as Public Law 114-198. Section 702(a) of the CARA amended 21 U.S.C. 829 of the Controlled Substances Act (CSA) by adding subsection (f) to allow a pharmacist to partially fill a prescription for a schedule II controlled substance under certain conditions. Specifically, subsection (f)(1) allows such partial filling where requested by the prescribing practitioner or the patient provided that all of the following conditions are satisfied: (1) The partial filling must not be prohibited by State law; (2) the prescription must be written and filled in accordance with the CSA, DEA regulations, and State law; and (3) the total quantity dispensed in all partial fillings must not exceed the total quantity prescribed. In addition, subsection (f)(2) provides that the remaining portions of a partially filled prescription for a schedule II controlled substance, if filled, must be filled no later than 30 days after the date on which the prescription is written, unless the prescription is issued as an emergency oral prescription, in which case the remaining portion, if filled, must be filled no later than 72 hours after it was issued.

This final rule is revising DEA regulations to incorporate the foregoing statutory provision. In addition, DEA is further revising its regulations to address regulatory requirements not addressed by section 702(a) of the CARA. This provision does not address how the prescribing practitioner should indicate that a prescription for a schedule II controlled substance must be partially filled. Likewise, it does not specify how a pharmacist should record the partial filling of such a prescription. However, it does provide that partial filling of prescriptions for a schedule II controlled substance is permitted if the prescription is written and filled in accordance with, among other things, regulations issued by DEA. 21 U.S.C. 829(f)(1)(B). Accordingly, Congress gave DEA explicit authorization to fill in any gaps in the regulatory scheme not addressed by Congress itself in section 702(a) of the CARA. DEA is exercising this authority by issuing this rule to give practitioners and pharmacists clear guidance in this area, and to allow for proper auditing by DEA.

There is potential for benefit to patients and society as a result of this rule. For patients, partial filling could lower the cost of prescriptions by reducing the quantity of unused schedule II controlled substances due to not needing to continue on drug therapy. Reducing the dispensing of schedule II controlled substances that are ultimately not needed would also help to reduce the risk that the patient might develop physical dependence or an addiction to opioids or other schedule II controlled substances. The existence of unused drugs in U.S. households contributes to growing rates of substance misuse of prescription drugs among Americans. Keeping and storing unused medications in households pose several risks related to diversion, accidental overdose, and consumption of spoiled substances. 1 Reducing the quantity of unused schedule II controlled substances would reduce the risk of diversion.

DEA published a notice of proposed rulemaking (NPRM) in the Federal Register on December 4, 2020, providing an opportunity for comments to be submitted. 85 FR 78282. The comment period closed February 2, 2021. While DEA invited comments on the entire NPRM, DEA specifically pointed commenters to the then proposed changes to 21 CFR 1306.13(b)(3), (4), and (5), which were filling in gaps not addressed by section 702(a) of the CARA. The other proposed amendments to 21 CFR 1306.13(b)(1) and (2) merely reiterated the statutory requirements of section 702(a) of the CARA, and therefore, cannot be changed.

DEA received 37 comments on the NPRM. Commenters included a nonprofit organization representing hospitals, a trade association representing chain drug stores, an association representing pharmacy boards, three professional pharmacist associations, practicing nurses and nurse practitioner students, and other individual or anonymous commenters. Most commenters generally supported the rule with some of those supporters also raising issues of concern or desiring clarification. Some commenters who opposed the rule primarily expressed concern about the impact on individuals with chronic pain, mistakenly assuming that the rule, if finalized, would require a prescription for a schedule II controlled substance to be partially filled. In fact, the rule simply proposed amending DEA's regulations to allow an option for a prescription for a schedule II controlled substance to be partially filled, if requested by the prescribing practitioner or patient. The comments are summarized below, along with DEA's responses.

Issue: Several commenters expressed opposition to provisions of the rule that were mandated by Congress, stating that the government should not interfere with the prescribing of medicine.

Response: As discussed in the NPRM, the provisions which are directly from the CARA cannot be modified. DEA has to allow both the patient and the practitioner to request partial fills. However, because DEA was granted the authority to fill in gaps not addressed by the CARA, DEA is able to create regulations to direct the manner which the partial fill is to be requested and recorded. Also, the government may be involved in the prescribing of medicine, as agencies such as Indian Health Services, Department of Veterans Affairs, Department of Defense, and Bureau of Prisons can serve as the healthcare provider.

Issue: Commenters expressed concern over DEA's stance in the proposed rule's preamble and in the proposed amendment at 21 CFR 1306.13(b)(1)(ii) regarding the validity of a prescription. Specifically, commenters urged DEA to reconsider its position, expressed in the proposed rule, of interpreting a prescription to be invalid if the quantity exceeds the limits of state law. An association asked for clarification and guidance when the partial fill is the result of limitations set by state or local law. One association stated that this is inconsistent with DEA policy that was set forth in a DEA policy letter dated August 24, 2011, and that DEA will cause confusion amongst healthcare providers. The association's comment included a quote from this DEA policy letter, which stated “DEA expects that when information is missing from or needs to be changed on a Schedule II controlled substance prescription, pharmacists use their professional judgment and knowledge of state and Federal laws and policies to decide whether it is appropriate to make changes to that prescription.” Commenters stated that this conflicts with the position taken in the proposed rule and that it also is inconsistent with many state laws, which allow a prescription written in excess of state limits to still be considered valid. Furthermore, commenters stated that multiple State Boards of Pharmacy have also issued guidance saying that state laws do not require pharmacists to confirm the validity of higher quantity prescriptions for schedule II controlled substances with the prescribing pharmacist, due to states having exceptions to their quantity limits. Finally, multiple commenters asked DEA to clarify the actions that pharmacists will be allowed to do regarding the partial filling of a prescription for a schedule II controlled substance and to revise the proposed regulatory text to ensure pharmacists can continue changing the partial fill quantities when prescriptions are written in excess of state limits.

DEA Response: In the NPRM's preamble, DEA acknowledged that many states have begun enacting partial fill laws and limiting the amounts allowed to be prescribed for initial prescriptions. 2 DEA referenced the CARA which states that a prescription for a schedule II controlled substance may be partially filled if the act of doing so is not prohibited by state law, and the prescription is written and filled in accordance with DEA regulations and state law. 21 U.S.C. 829(f)(1).

DEA wishes to clarify that where state law provides exceptions or exemptions for prescriptions for schedule II controlled substances which exceed the state limit for quantity, the prescription is not considered in violation of the CARA. DEA notes that in the NPRM, the stance was taken that a prescription written in excess of state law would be considered invalid. However, in light of information received from commenters, DEA has learned that states have begun implementing laws and issuing guidance to address prescriptions written in excess of state law quantity limits.

In acknowledgement of those states' actions, DEA will not consider a prescription for a schedule II controlled substance to be invalid when written in excess of the state limit, when the state has provided an exception or exemption. In light of the comments discussed above, DEA is not adopting the final two sentences of the proposed regulatory language for 21 CFR 1306.13(b)(1)(ii), which had proposed to provide that, “A prescription written for a quantity that exceeds the limits of State law is not a valid prescription, therefore, the prescription may not be filled as written. Because such a prescription is not valid, it also cannot be partially filled.”

Regarding the commenters' request to change the regulatory text to allow pharmacists the authority to modify prescriptions by fixing the amount of the partial fill so that it is not in excess of a state's limit, DEA declines to make such a change. DEA considers the August 2011 policy letter—referenced by several commenters—to be a guidance document which is no longer in effect. The only guidance documents currently in effect are those which are located on DEA's website in the guidance portal. 3 This policy letter is not in the guidance portal. DEA's regulations do not provide for a pharmacist to modify a prescription for a schedule II controlled substance. Where a pharmacist knows that a modification is needed to address the amount being in excess of the state's limit (and the state does not have an exception or exemption in place), the pharmacist should use their knowledge of state laws and state guidance and return the prescription to the prescribing practitioner.

Issue: There were twenty-two comments received discussing the proposed amendment for 21 CFR 1306.13(b)(3). Many of the comments received regarding the request of partial fills from a practitioner stated that this proposed addition to DEA's regulations provides clear guidance to prescribers, and will encourage practitioners to prescribe schedule II controlled substances sparingly. There were also comments with a few suggested modifications and requests for clarifications on the proposed regulatory text for practitioner requested partial fills.

Commenters stated that practitioners rarely request a partial fill when the prescription is first issued, and they usually do not choose this option until it is presented by the pharmacist to them. A few associations and other commenters suggested that DEA explicitly recognize that the prescriber may authorize a partial fill at a later date, following a consultation with a pharmacist, constituting an amendment to the original prescription. In effect, many of the commenters requested the authorization for pharmacists to dispense a partial fill for the prescription without requiring the prescribing practitioner to issue a new prescription.

DEA Response: DEA appreciates all of the comments received in response to the proposed amendments for the partial fills requested by practitioners. DEA joins the commenters in hoping that this will help address the opioid and overdose crisis and encourage practitioners to consider all options available when prescribing schedule II controlled substances.

Through this rulemaking, DEA has come to understand that many practitioners do not request partial fills on prescriptions for schedule II controlled substances initially. Instead, the request comes after the pharmacist receives the prescription and then contacts the prescribing practitioner to discuss that prescription. In response to the commenters' concerns, DEA wants to clarify in 21 CFR 1306.13(b)(3) that a partial fill may be authorized by the prescribing practitioner during subsequent communication between the pharmacist and practitioner following the date after the prescription was first issued. This authorization would still be considered a request by the practitioner and a new prescription will not be required.

Through this final rule, the pharmacist must add the partial fill request to the prescription for a schedule II controlled substance by notating on the prescription “Authorized by Practitioner to Partial Fill.” The annotation must also include the name of the practitioner they spoke with, the date and time of the communication, and the pharmacist's initials.

DEA's regulations do not provide for pharmacists to modify prescriptions for schedule II controlled substances. As such, DEA does not consider the notations made by the pharmacist, as a result of the subsequent communication with a practitioner after the prescription was issued, to be an amendment or modification to the prescription. DEA declines the commenters' request to grant authorization for pharmacists to amend or modify prescriptions for schedule II controlled substances.

Issue: DEA received fifteen comments addressing the proposed provision for 21 CFR 1306.13(b)(4), most in support of partial fill by patient request. Many of the commenters also provided suggestions or sought clarification on issues presented in the questions in the “Economic Impact” section of the NPRM. 4 Those issues are addressed later in “Discussion of Economic Comments” section.

Some commenters stated that this proposed amendment was too narrow of an interpretation of Congressional intent in the CARA. A commenter also said that it conflicts with the Federal Health Insurance Portability and Accountability Act (HIPAA) privacy requirements found at 45 CFR 164.510(b)(3), 5 which set the standard for limited uses and disclosures of protected health information (PHI) when the individual is not present. Specifically, a commenter noted that DEA, in the proposed rule, interpreted “patient,” as used in the CARA, to not include a member of the patient's household. Commenters stated caregivers should be authorized to request a partial fill of prescriptions without the involvement of the patient, as many caregivers/representatives are dropping off and/or picking up prescriptions on behalf of the patient. Commenters also gave the example of a caregiver for a minor child or a caregiver for a dependent adult who has a medical power of attorney as someone who should be authorized to make the partial fill request. A commenter further stated that because patients are not usually initiating the partial fill request (without the suggestion/involvement of the pharmacist), they are unlikely to send a written request with the caregiver or call ahead to the pharmacy to make such a request.

Commenters also suggested that doctors should educate patients on the option to request partial fill of prescriptions, otherwise a patient may not make the request on their own. It was suggested this should include potential risk, and proper disposal, and address patients' fears associated with both schedule II controlled substances and the partial fill process. This would promote patient-centered care and empower patients with the opportunity to contribute to their own treatment plan.

A commenter suggested that the partial fill request by the patient only be allowed with an accompanying recommendation by the pharmacist because the pharmacist would be more knowledgeable than the patient about patient tolerance and compliance history. Others maintained that the pharmacist should not have to concur with the patient on whether a partial fill is best for the patient, and that a pharmacist should be granted the authority to dispense the partial fill to the patient without the patient's requesting or consenting to the partial fill. One commenter provided an example to show that a pharmacist is more knowledgeable than the patient about how long a patient may need to take a prescription to address short-term pain management.

DEA Response: The comments pertaining to the questions in the economic impact section of the NPRM are addressed later in the “Discussion of Economic Comments” section.

With regard to allowing a partial fill at the request of a caregiver, DEA recognizes there is the possibility that there are situations where a caregiver is aware of the benefit for a partial fill request while the ultimate user (the patient) is unable to provide the request, however the possibility for abuse of this authority is greater than the possible benefit. Typically, the patient's right to request, or not request, a partial fill of their prescription is their right to exercise; the caregiver's authority is borne of the patient's requests, and the division of authority should be maintained accordingly. Usually in those situations where a patient is unable to make the request themselves, a caregiver would also participate in the patient's interaction with the prescribing practitioner. Their concerns would be addressed with the prescribing practitioner and the prescribing practitioner would be able to issue a prescription with a partial fill request.

While DEA understands the concerns regarding the HIPAA regulations, it should also be noted that the CARA only authorizes the “patient”—not a member of the patient's household or the patient's caregiver—to make such request. DEA's interpretation of section 829(f) of the CSA is not too narrow, as that section only refers to “the patient or the practitioner that wrote the prescription” making the request for the partial fill. However, DEA acknowledges that in the case of a minor (under age 18), a parent or legal guardian is often the responsible party for the care of the child and therefore, is updating the regulatory text to allow the parent or legal guardian to make a partial fill request on behalf of the child. In addition, DEA also understands that there are instances where an adult patient may have a caregiver who is named as their agent in the adult patient's medical power of attorney; therefore, DEA is updating the final regulatory text to allow a caregiver who is the agent named in the adult patient's medical power of attorney to request a partial fill on behalf of that adult patient.

It is always good practice for a patient and their doctor to engage in open dialog about the potential risks, proper disposal, and addressing the patient's fears associated with both schedule II controlled substances and the partial fill process. It is not, however, within the purpose of this rule, or the mission of DEA to involve itself in the practice of medicine or to enforce the elements of good patient education beyond providing rules, policy, and enforcement.

Last, if a patient is requesting a partial fill then they are already taking good steps to mitigate any potential harm or damage that could come as a result of receiving the full prescription. A pharmacist would more than likely want to encourage the partial fill alternative rather than suggest against making the request. If a patient's tolerance and compliance history is at issue, then a partial fill request would be best in mitigating any potential addiction behavior and diversion risks. In the event that a pharmacist does not want to have the consent of the patient for a partial fill, the pharmacist still has the option of suggesting a partial fill to the prescribing practitioner. Together, a pharmacist and the prescribing practitioner would be well-equipped with the knowledge to determine the dosage quantity necessary to manage a patient's short-term pain.

Issue: There were six comments related to the proposed amendment in 21 CFR 1306.13(b)(5)(i), some of which discussed the recording requirement in relation to the economic impact. The commenters requested clarification of the pharmacist's recordkeeping requirements for fulfilling partial fill requests by prescribing practitioners and patients, specifically regarding electronic recording of dispensing for written records when requested by a practitioner. Commenters stated that the recordation by the pharmacy is warranted and expressed appreciation towards DEA for not requiring a pharmacist to notate a partial fill request by a patient when the prescribing practitioner had already included the request on the prescription, unless the patient is asking for an even smaller amount. However, another commenter believes that the recordkeeping requirements are redundant and the regulatory text should be revised to just require pharmacists to make an annotation in the electronic dispensing record.

DEA Response: As proposed in the NPRM, and being finalized in this rule, 21 CFR 1306.13(b)(5)(i) will require the pharmacist to notate the quantity dispensed on the face of the written prescription, in the written record of the emergency oral prescription, or in the record of the electronic prescription. When it is an electronic prescription, the quantity dispensed, date dispensed, and the dispenser must be linked to the record of the electronic prescription. However, due to commenters' concerns as well as common practices of DEA's Diversion Investigators, DEA is updating the regulatory text to allow the option for pharmacists to fulfill recordkeeping requirements for paper or emergency oral prescriptions using the pharmacy's electronic recordkeeping system.

The comments which also discussed the economic impact of recording the practitioner's partial fill request are addressed below in the “Discussion of Economic Comments” section.

Issue: DEA received fifteen comments related to the proposed amendment in 21 CFR 1306.13(b)(5)(ii). Comments included appreciation for the clear communication of the requirements established by this rule, while others suggested modifications.

Of the commenters requesting modifications, several commenters suggested that DEA revise the proposed language to allow pharmacists to satisfy the recordkeeping requirement by making an annotation in the electronic dispensing record, regardless of the format of the original prescription. Commenters stated that DEA is creating a redundant requirement by requiring a notation of the quantity dispensed on the face of the written prescription, in the written record of the emergency oral prescription, or in the record of the electronic prescription.

Lastly, commenters suggested that DEA eliminate the proposed dispensing recordkeeping requirement when a prescriber has already instructed a partial fill and the patient requests less than the instructions, as the total quantity dispensed compared to the total quantity prescribed will be obvious based on the dispensing record.

DEA Response: DEA recognizes that commenters found the NPRM to be clear in setting forth these recordkeeping requirements, as it was the intention to be clear in presenting and discussing the requirements that will be implemented with this final rule.

As stated in the previous response to issues identified for the practitioner's partial fill request, DEA is changing the regulatory text to allow pharmacists to satisfy the recordkeeping requirement by using the pharmacy's electronic system regularly used for recordkeeping. DEA notes that Diversion Investigators regularly look at the pharmacy's electronic system for paper prescriptions also.

Regarding the notation of prescriptions based on the prescribing practitioners' method, written prescriptions, emergency oral prescriptions, or electronic prescriptions, this rule acknowledges that different types of prescriptions exist. Accordingly, the various types of prescriptions may require varying methods for annotation of the partial fill option to prevent over dispensing of controlled substances. This results in the illusion of redundancy because of the numerous means by which the partial fill can be requested.

Regarding the comment on the required documentation when a patient requests a lesser partial fill amount than that specified by the prescribing practitioner, DEA maintains that it is necessary for the dispensing pharmacist to annotate the patient's request. Because of the justifications already established in 21 CFR 1306.13 for partial fill dispensing of a prescription for a schedule II controlled substance ( e.g., 1306.13(a) partial filling due to inability of the pharmacy to supply the full quantity), and the legal mandate by the CARA for the patient's right to request a partial fill, it is necessary that annotation be made for any partial fill requests that may be different from the partial fill amount requested by the prescribing practitioner. The documentation of these modifications from the prescribing practitioner's original instruction of partial fill, at the request of the patient, helps to prevent any suspicion of diversion due to deviation from the original prescription. DEA does not interpret the CARA to allow any “assumption” for a justification of a more limited dispensing than originally requested.

Issue: An association requested that the effective date of the rule be set at six months after the publication of the final rule. The association stated that pharmacies will need adequate time to update their systems, policies, and procedures to be in compliance with the new requirements.

DEA Response: DEA acknowledges the association's concern regarding being in compliance with DEA's regulations. However, DEA notes that many, if not all, electronic pharmacy systems already have the ability to show partial fills. Also, many systems may have a free text field that would allow a pharmacist to use for additional notes. In addition, since many states have already implemented partial filling regulations, DEA further believes that many pharmacies already have the needed systems to effectuate the allowance of partial fills. DEA notes that many of the policies and procedures that this association may view as a need to be updated are not so involved that pharmacies would need more than 30 days. As such, DEA is making this rule effective 30 days after the publication of the final rule.

Issue: DEA received a comment from an association which requested clarification and written guidance in addressing cases when a pharmacist is unable to supply the full quantity in a prescription for a schedule II controlled substance, as well as three additional situations. One of the additional situations, “Situation 2,” pertains to when the prescription quantity exceeds the quantity limits set by state or local law. This situation has already been addressed above in the “General Requirements” Section. “Situation 1” asks for guidance to be provided when dealing with a partial fill resulting from a health plan insurer's benefit rules. For “Situation 3,” the association wants guidance on how to proceed when the pharmacy has a policy which limits the quantity that can be dispensed at a time.

DEA Response: DEA has already implemented regulations addressing a partial fill as a result of a pharmacy being unable to supply the full quantity in a prescription for a schedule II controlled substance. Pursuant to 21 CFR 1306.13(a), the partial fill is permissible and the pharmacist has to make a notation of the quantity supplied on the face of the written prescription, the written record of the emergency oral prescription, or in the electronic prescription record. In addition, the remaining portion may be filled within 72 hours of the first partial filling. If the pharmacy cannot fill the remainder in that time, they are to notify the prescribing practitioner.

Situations (1) and (3) are not subject to section 702 of the CARA, as these would not be requests by the patient nor practitioner for a partial filling. For either of these situations to be covered by this rulemaking, they would need to be considered a request by the patient or the practitioner. In these situations, the pharmacist should discuss options for filling the prescription with the prescribing practitioner. Furthermore, in Situation (1), a patient's decision to receive the full prescribed amount despite health plan coverage limitation would also fall outside of section 702 of the CARA, as it would not be a partial fill request.

DEA appreciates all comments that were received during the comment period. DEA received some general comments which were outside of the scope of this rule. They did not touch on the actual changes to the proposed regulatory text, nor did they answer any of the economic questions that were put forth.

The NPRM contained a Regulatory Analysis section which assessed the economic implications of this rulemaking. DEA examined the costs and costs savings associated with this rulemaking, as well as considered three regulatory approaches regarding the need to require notification when a partial fill is requested by the patient. DEA stated that this was an evaluation of activities that were not previously permitted before the CARA amended the CSA to add 21 U.S.C. 829(f), and therefore, it was difficult to estimate the level of participation for partial filling of a prescription for a schedule II controlled substance. As such, DEA also asked eight questions of the public related to the economic impact of the NPRM.

Issue: Many of the commenters questioned whether the patient will be charged two co-pays, stating that the filling of the remainder of the prescription should not create an additional financial burden for the patient. They further stated that this rule should have a positive economic impact because it should result in a lower co-pay, and if the remainder of the prescription needs to be filled, the additional co-pay should add up to be the same amount as a full co-pay. An association requested for DEA to state how a partial fill should be adjudicated by pharmacies to calculate out-of-pocket costs, so that access issues for patients are not created. Multiple commenters stated that this rule would have a positive impact because the unused prescriptions should decrease demand for opioids, making the drug prices lower. They also noted that implementing partial fills can reduce waste, cost, misuse, and abuse potential.

Commenters stated that the rule would increase the time, cost, and overall waste for practitioners by increasing the time spent writing and transmitting prescriptions. Commenters referenced an increased need to educate patients and practitioners, and that DEA should calculate this into the overall increased-cost (Economic Impact) of this rule. One association in particular mentioned that while there is the potential to reduce the amount of unused drugs, they questioned whether there will be a significant cost savings. The association explained that most patients pay a co-pay which does not necessarily decrease based upon small changes in drug quantity. They also expressed the concern that if co-pays are not reduced for partial fills, then a patient may pay multiple co-pays, resulting in more money out of pocket.

Associations showed much support for Alternative 3, which was chosen by DEA, commenting that they support allowing pharmacists to dispense partial fills requested by the patients, without requiring notification to, or consent from, the prescribing practitioner. Commenters believe that this alternative places the least amount of burden on pharmacists, practitioners, and patients because it does not pose a threat to patient safety and allows a pharmacist to dispense the remainder of the full prescription. However, one association expressed concern that DEA's estimated time that it takes a pharmacist to record a partial fill (10 seconds) is too low, and recommended that DEA conduct a more in depth study to accurately determine the recording time. In addition, this association stated that it would be a larger time, cost, and administrative burden placed upon pharmacists in filling the remainder of the prescription, and advocated for pharmacists to be adequately reimbursed.

Commenters suggested that Alternative 3 will facilitate rule utilization by allowing a pharmacist to dispense per a patient's request independently of the prescriber. They opined that governmental regulation is not the most appropriate way to limit misuse and diversion. The commenters stated that partial fills requested by a patient should not require consent from a practitioner. They further commented that not requiring consent from a practitioner would reduce cost and burden to the practitioner, pharmacist, and patient. Commenters expressed that allowing a pharmacist to dispense the partial fill as requested by the patient without consent of the prescriber is the most cost-effective approach. One of these commenters stated that a provider would not refuse a partial fill request by the patient during this opioid epidemic.

DEA Response: DEA understands the concerns of co-pay affordability expressed by commenters and agrees that partial fills should not create an additional financial burden on patients. DEA joins the commenters in hoping the implementation of this rule will create a positive economic incentive for all parties to request partial fills. DEA did not receive comments from industry regarding co-pays for partial fills. The intent of this rule is to implement section 702(a) of the CARA that amended the CSA to allow for the partial filling of prescriptions for schedule II controlled substances under certain conditions. DEA does not have the authority to mandate how a pharmacy or an insurance company may charge for partial fills.

To estimate the prescriber's cost of specifying partial fill instructions on the prescription, DEA considered the entire duration of the interaction between the prescriber and the patient, as well as the prescription writing and transmittal process. While any additional time to specify the quantity to be dispensed in the partial filling is minimal, especially, when viewed in relation to the entire duration of the medical interaction between the prescriber and the patient, DEA estimates each partial fill requested by the prescriber will require 10 additional seconds for the prescriber to specify the quantity to be dispensed. DEA believes 10 seconds is a reasonable estimate and the corresponding cost is included in the economic analysis.

While DEA agrees that educating prescribers and patients regarding the option to partial fill may increase the likelihood of instructing or requesting a partial fill, DEA does not plan to require prescribers or pharmacies to inform patients due to the potential burdens. DEA informs prescribers and pharmacies of such issues through various routine conferences and outreach such as: Practitioner Diversion Awareness Conferences and Pharmacy Diversion Awareness Conferences.

Regarding the association's concern that the estimated burden to pharmacies is too low, DEA selected Alternative 3 to minimize burden to prescribers, patients, and pharmacies. While DEA always appreciates comments, the issue of the estimated burden being too low was not raised in any other comments, indicating it was not considered an issue of note. Additionally the absence of any suggested alternative for the process study or improved estimation leaves little room to directly address the comment. For these reasons DEA declines to revise the estimate. DEA believes the burden estimates contained in this rule are reasonable estimates.

DEA appreciates the support for Alternative 3. DEA estimates this alternative minimizes the burden placed on patients, prescribers, and pharmacists.

Below are the eight questions asked in the NPRM to help determine the economic impact of this final rule. DEA has summarized the applicable comments received and addressed them, as applicable.

1. Why do so many prescriptions for schedule II controlled substances result in unused dosages?

Comments: No comments were received in response to this question.

2. Would prescribers start using this proposed regulatory provision and start giving instructions for partial filling of schedule II controlled substances, or are there other factors that are likely not to result in prescribers giving partial filling instructions?

Comments: Commenters pointed to the willingness of a practitioner to start giving instructions for partial filling, but stated their belief that many patients may be reluctant to change. A commenter stated that many of the patients are used to seeing their longstanding family providers who frequently prescribed the schedule II controlled substances without assessing other treatment options first. The commenters expressed that when practitioners attempt to discontinue prescribing these substances and have the patient use other treatment options, patients do not tolerate the change well, forcing practitioners to renew the prescriptions as they are, without partial fill instructions.

Commenters also provided feedback with discussions of how a practitioner giving partial filling instructions would increase the amount of time a provider spends writing and sending prescriptions, and increase the amount of education needed for a patient to understand the available options for filling a prescription. The commenters explained that a practitioner giving partial fill instructions will increase the visit time with each patient, and stated that DEA needs to calculate and include this extra time in the economic impact discussion of the final rule.

DEA Response: While DEA appreciates the opinions stated in the comments, DEA believes that they were speculative in nature. As there was no additional data provided that would warrant revision of DEA's estimated number of partial fills at the direction of the prescriber, no change to the estimate will be made.

Regarding the time that partial fill instructions would require, DEA took the physical requirements of writing the additional information into consideration in developing the Economic Impact Analysis. The additional time to specify the quantity to be dispensed in the partial filling is minimal, especially when viewed in relation to the entire duration of the medical interaction between the prescriber and the patient. DEA estimates, for both the NPRM and this Final Rule, that each partial fill requested by the prescriber will require 10 additional seconds for the prescriber to specify the quantity to be dispensed. The resulting cost to prescribers is included in the regulatory analysis section below.

3. How often would a prescriber instruct partial filling of a prescription for a schedule II controlled substance?

Comments: Some commenters asserted that it is extremely rare for a prescriber to instruct that a prescription be partially filled. They added that it is only after a consultation with a pharmacist that the option is made available to the patient which indicates that prescribing practitioners are not utilizing and are not educating their patients on the option for partial fill.

DEA Response: As stated in an earlier response to comments, this final rule makes changes to proposed 21 CFR 1306.13(b)(3) so that a prescriber instructing a partial fill after a consultation with a pharmacist is considered as a partial fill at the request of the prescriber. DEA did not receive information that would allow DEA to refine the percent of the partial fill opportunity that will be realized as a result of this rule.

4. Is it reasonable to anticipate a prescriber will exercise professional judgment and foresight in determining when partial fill would be most appropriate, resulting in a minimal number of patients returning for the remainder of the partially filled prescription or experiencing pain because they run out of medication? Would prescribers be likely to use consistent criteria for determining when to give partial refills? Given that the majority of schedule II prescriptions are not fully utilized, should prescribers request partial fills in most cases?

Comments: Commenters stated that practitioners receive extensive training and are skilled in relaying facts and concerns to their patients. They further stated that most practitioners have the patient's best interests and health at heart and they will do what they can to facilitate best practices and patient safety.

Many commenters expressed concern regarding biases held by practitioners. Specifically, these commenters voiced concern that without criteria to go along with this rule, practitioners will use their implicit biases to dictate when they choose to prescribe partial fills for a patient. Commenters stated that these biases are a result of racial and ethnic disparities in healthcare. One commenter gave an example that Black patients are less likely to be prescribed pain medications and they receive lower dosage amounts. A commenter also explained that there are some tribes with high rates of opioid addiction and therefore, some practitioners may prescribe less quantity or choose a partial fill for them based off assumptions rather than real risks for addiction.

DEA Response: While DEA did not get answers to the last part of this question, it is apparent that many commenters are concerned that instructions for partial fills will not be given equally across the board. DEA appreciates the commenters' concern and understands that this is a significant cause for concern. However, DEA does not regulate the practice of medicine and it is expected that practitioners would do so without bias. DEA's regulations are an extension of the CARA, and only serve to implement that legislation which was passed by Congress. While this issue may be of significant concern, it is therefore outside the authority granted to DEA by the CSA. DEA did not receive information that would allow DEA to refine the economic analysis.

5. How likely are patients to request partial filling at the pharmacy when the prescriber has not given instructions for a partial fill on the prescription?

Comments: The comments received by DEA stated that a patient would probably ask for the full prescription on the day that their pain is high, as they probably think the pain will remain at that level throughout their recovery. A commenter opined that when patients are suffering from an acute problem, it is unlikely that they would opt for partial fills because that would require two trips to the pharmacy in 72 hours versus one trip. Other commenters stated that patients are less likely to request a partial fill on their own when they do not know much about the prescribed drug and expected outcomes. They also said that patients need to have discussed with their practitioners the potential risks, proper disposal, and any of the patient's fears.

In addition, commenters expressed concern that socioeconomic factors could negatively impact the filling of the remainder of the prescriptions, as patients may not be able to afford the remainder of the prescription. These commenters stated that patients may not be able to afford the medicine, with possible additional co-pay fees, or may lack the means for transportation to and from the pharmacy. Commenters further stated that patients may alternatively request the partial fill because they know that they will not need the entire amount prescribed and they want to limit the exposure for themselves or their households to the controlled substances.

DEA Response: DEA acknowledges that a current state of intense pain could influence one's ability to recognize that the level of pain will diminish over time. DEA encourages patients that are informed by their provider about the option of partial filling to discuss their options with the pharmacist and, with the pharmacist's help, make the best choice for their situations. DEA did not receive information that would allow DEA to refine the economic analysis.

6. Is it reasonable to assume that a patient interested in a partial filling of a schedule II controlled substance would request the prescriber to provide instructions on the prescription?

Comments: DEA did not receive any comments specifically offering feedback on this question. However, DEA received comments offering insight for the other questions which helped DEA gain insight about the answer to this question. The commenters offered insight that a patient may face transportation issues or may be in so much pain at the time that the prescription would be written that they would not want a partial fill.

DEA Response: While DEA did not receive any feedback directed towards this question, DEA notes that responses to other questions helped DEA gain insight to this situation. DEA understands that some patients may experience hardships with getting to and from the pharmacy. DEA also acknowledges that there are times when a patient's pain may be so intense that they cannot recognize the likelihood that the pain will diminish with time. The comments received did not include information that would allow DEA to refine the economic impact analysis.

7. Is it reasonable to assume that when prescribers do not request a partial fill patients will generally not request a partial fill?

Comments: While DEA did not receive comments that specifically addressed this question, it is reasonable to infer from the comments in general that patients may not request a partial fill when their practitioner did not prescribe it. As previously observed, commenters mentioned that many patients may choose to receive the entire quantity that was prescribed for various reasons. The commenters explained that a patient may know that they will have a hard time returning to the pharmacy due to lack of transportation. Commenters also stated a patient may feel that they are in so much pain that they would need the entire amount. In addition, commenters mentioned that patients may not know that they can request a partial fill.

DEA Response: DEA appreciates the comments received that allowed for inference on answers to this question. While DEA wished to collect additional information to aid in the understanding of and possible refinements to the economic impact of this rule, no responses provided any such information that facilitated refining the existing economic analysis.

8. Questions for industry including private and public plans and entitlements:

a. What are likely requirements for co-pay in a partial filling?

b. Would the co-pay be reduced?

c. Would there be a co-pay when a patient returns for filling the remainder of a partially filled prescription (full amount or reduced amount)?

d. Would a patient likely spend less on a partial fill than on a full prescription?

e. If so, would requesting two or more partial fills likely cost the patient more than filling the full prescription initially?

Comments: No comments specifically answered these questions. Many commenters hoped that this provision would not result in a multiple co-pay charge. One association in particular voiced concern regarding partial fills resulting in double co-pays for patients. Commenters hoped that this would mean a lower co-pay for a partial fill, otherwise there would not be any savings.

DEA Response: DEA acknowledges and understands the commenters' concerns. With this rulemaking, DEA is not setting guidelines for insurance companies. DEA does not have the authority to mandate how insurance companies should charge their customers. DEA had hoped to receive feedback from insurance companies so that DEA could offer more guidance to the public, however no insurance companies provided comments on this question. DEA notes that its regulations already allow partial fills for prescriptions for schedules III-V controlled substances  6 and in instances of limited supply, for schedule II controlled substances. 7 DEA anticipates that insurance companies would follow the same methods for assessing co-pays for prescriptions for schedule II controlled substances as it currently does for prescriptions for schedule III-V controlled substances. However, DEA cannot be sure of that theory; therefore, DEA defers to insurance companies on how they will handle co-pays for partial fills. DEA did not receive information that would necessitate refining the economic analysis.

DEA is implementing and finalizing the proposed regulatory text with modifications, discussed below, to clarify concerns brought forth by commenters. As proposed, to implement the partial filling provisions of CARA for prescriptions for schedule II controlled substances, DEA is re-designating existing paragraphs (b) and (c) of 21 CFR 1306.13 as paragraphs (c) and (d), respectively. This final rule places the provisions for partial filling in new paragraph (b). Here, registrants will find the requirements for patients and practitioners to request partial fills under certain circumstances and the involved notation by the prescriber to specify the partial fill request, as well as the involved recording by the pharmacy of the partial filling itself.

All of the “ General requirements ” provisions are being implemented as proposed, with the exception of 21 CFR 1301.13(b)(1)(ii). Generally, the prescribing practitioner or a patient must request a partial fill for a prescription for a schedule II controlled substance. Such a prescription may be partially filled if it is not prohibited by State law and it is written in accordance with the CSA, DEA regulations, and State law. Also, the total quantity dispensed in all of the partial fillings cannot exceed the total quantity prescribed by the practitioner.

In the NPRM, the preamble and the regulatory text in 21 CFR 1301.13(b)(1)(ii) stated that a prescription was invalid if it set forth a dispensing quantity of a controlled substance that exceeded the state limits, and therefore would be ineligible for a partial filling. In light of the public comments, as well as various implemented state legislation and guidance providing exemptions or exceptions for prescriptions written in excess of the state limits, DEA will not implement that portion of the proposed amendment, and is deleting the final two sentences of the proposed regulatory text as a result.

DEA is adding 21 CFR 1301.13(b)(2) as proposed. After the first partial fill of the prescription for a schedule II controlled substance is filled, if a patient chooses to fill the remainder, the remaining portions must be filled no later than 30 days after the date of the prescription. However, when it is an emergency oral prescription, the remainder, if filled, must be filled no later than 72 hours after the date of the prescription.

DEA is adding 21 CFR 1306.13(b)(3) which will require the practitioner to specify the quantity to be dispensed in the partial filling on the face of the written prescription, in the written record of the emergency oral prescription, or in the record of the electronic prescription. This information must be included on the prescription, along with other information required for issuing a prescription under 21 CFR 1306.05, at the time it is signed by the practitioner. In the case of an emergency oral prescription, this information must be given when the prescription is being communicated by the prescribing practitioner to the pharmacist. This approach ensures that the practitioner's intent regarding partial filling is made clear to the pharmacist, and is properly memorialized in the dispensing records.

The term “record of the electronic prescription” is being used in place of the term “electronic prescription record,” which was utilized in the NPRM. The previous term, “electronic prescription record,” was ambiguous and could imply a hard-copy/written prescription being tracked electronically by a pharmacist after receipt. The new term, “record of the electronic prescription,” clarifies a prescription that is generated and transmitted electronically, and is having a record attached by the prescription-tracking software utilized by the pharmacist.

This final rule amends the proposed provision to authorize a practitioner to stipulate a partial fill or refill at a later date than when issuing the original prescription, after an oral consultation between the practitioner and the pharmacist, and specifies that the pharmacist must annotate the discussion on the prescription as stipulated in 21 CFR 1306.13(b)(5)(i).

This provision is being finalized to allow a patient to request the partial filling of a prescription for a schedule II controlled substance at the pharmacy, even if the prescribing practitioner did not specify a request for a partial filling, as provided in 21 CFR 1306.13(b)(3). Section 702(a) of the CARA does not place any limitations on how the patient may make a partial fill request. In addition, DEA recognizes that many post-surgery patients may have a difficult time visiting the pharmacy in person. Therefore, this rule does not require an in-person request by the patient, but instead allows alternative pathways for the patient to make such a request and specify the amount to be filled ( e.g., phone call by the patient to the pharmacist, or a signed written note from the patient and delivered by a family member to the pharmacist). As proposed and discussed earlier, the partial fill can only be requested by the patient, not a member of the patient's household or a caregiver. However, this final rule is revising the proposed provision to also allow others to request a partial filling where the patient is a minor child (under age 18) or an adult who has named their caregiver as their agent in the adult patient's medical power of attorney. In those situations, DEA authorizes the parent or legal guardian for the minor child and the caregiver named as the agent in the medical power of attorney for the adult patient to request the prescription for the schedule II controlled substance to be partially filled in the same manner that a patient may request the partial fill: in person, in writing if signed by the parent or legal guardian (for the minor child) or the caregiver named in the medical power of attorney (for the adult patient), or by a phone call from the parent or legal guardian (for the minor child) or the caregiver named in the medical power of attorney (for the adult patient) to the pharmacist. Finally, where a practitioner has requested the partial filling of a prescription, neither the patient, a parent or legal guardian (in the case of a minor), nor the caregiver named in the medical power of attorney (for the adult patient) may request a partial filling in an amount greater than that specified by the practitioner.

This provision specifies how a pharmacist must record a partial fill of a prescription for a schedule II controlled substance when a practitioner makes such a request pursuant to 21 CFR 1306.13(b)(3), as discussed above. When presented with a prescription properly specifying a partial filling request, the pharmacist must record the partial filling in a manner similar to that required under the existing regulations for other circumstances. 8 Specifically, upon each such partial filling request, the dispensing pharmacist must make a notation of the quantity dispensed on the face of the written prescription or in the pharmacy's electronic recordkeeping system, in the written record or in the pharmacy's electronic recordkeeping system of the emergency oral prescription, or in the record of the electronic prescription. For electronic prescriptions, there must be an electronic prescription record, and the record must be permanently attached to the electronic prescription. Also, for each such partial filling, the pharmacy must maintain a record with the date of each dispensing, the name or initials of the individual who dispensed the substance, and all other information required by 21 CFR 1306.22(c) for schedule III and IV prescription refills. For electronic prescriptions specifically, pharmacy applications must allow required information pertaining to the quantity, date, and the dispenser to be linked to each electronic controlled substance prescription record (as also required by 21 CFR 1311.205(b)(10)).

These above provisions were as proposed with slight changes for clarification. As previously stated, the term “record of the electronic prescription” has been used in place of the term “electronic prescription record” here also to ensure the understanding that DEA is referring to a prescription that is generated and transmitted electronically. Also, as said above DEA is also allowing the notation of the quantity dispensed to be notated in the pharmacy's electronic records due to the regular business practices of pharmacies, as well as common practices of DEA's Diversion Investigators.

This final rule is revising the proposed regulatory text to allow for where the prescribing practitioner conveys his or her request for a partial filling after issuing the prescription, and is based upon an oral consultation with the pharmacist. In those situations, the dispensing pharmacist must notate such discussion with the following: “Authorized by Practitioner to Partial Fill,” the name of the practitioner, the date and time of the discussion, and the pharmacist's initials.

With the addition of 21 CFR 1306.13(b)(5)(ii), when partially filling a prescription for a schedule II controlled substance at the request of the patient, the caregiver of an adult patient who is named in their medical power of attorney, or a parent or legal guardian of a minor patient (under age 18), the pharmacist must make the same notation on the prescription as when partially filling a prescription as requested by the prescribing practitioner on the initial prescription. Also, just as with the pharmacy's recording requirements when the prescribing practitioner is the requester, if the prescription is electronic, then the notation must be linked to the record of the electronic prescription. Since the prescription will not contain the partial fill instructions from the prescriber, this rule also requires the pharmacist to indicate on the prescription who specifically requested the partial fill ( i.e., whether it is the patient, parent or legal guardian of a minor patient, or caregiver of an adult patient named in the adult patient's medical power of attorney). On all of such partial fill requests and filling, the pharmacist must record: (1) “The [patient, parent or legal guardian of a minor patient, or caregiver of an adult patient named in a medical power of attorney, whichever is applicable] requested partial fill on [date such request was made],” and (2) the quantity dispensed. As referenced in the section Partial Fill Request by Patient, where a practitioner has requested the partial filling of a prescription, the patient, parent or legal guardian, or caregiver of an adult patient may not request a partial filling in an amount greater than that specified by the practitioner.

Here also, the regulatory text is being finalized with slight changes. As mentioned above, DEA is finalizing the regulatory text using the term “record of the electronic prescription” in place of the term “electronic prescription record.” Also with finalizing this provision, DEA is allowing the pharmacist to notate the quantity dispensed in the pharmacy's electronic records.

As previously stated, DEA is finalizing this rule with changes for clarification in regards to the options which the pharmacy can notate the partial fill for recordkeeping requirements. This final rule adds the partial fill requirements of section 702(a) of the CARA into 21 CFR 1306.13(b) and redesignates existing paragraphs (b) and (c) as paragraphs (c) and (d), respectively. In the redesignated 21 CFR 1306.13(d) in this final rule, there is a reference in existing paragraph (c)(1) to 21 CFR 1306.13(b), which DEA is updating with this rule. DEA is changing that reference in redesignated paragraph (d)(1) to 21 CFR 1306.13(c).

This rule was developed in accordance with the principles of Executive Orders (E.O.) 12866 and 13563. E.O. 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, public health and safety, and environmental advantages; distributive impacts; and equity). E.O. 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in E.O. 12866. The E.O. classifies a “significant regulatory action” as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the E.O.

DEA expects that this rule will have an annual effect on the economy of $100 million or more in cost savings and therefore is an economically significant regulatory action. The analysis of benefits and costs is below. In the NPRM, DEA welcomed all comments that would narrow the uncertainties in the presented analysis. Furthermore, DEA asked prescribers, patients, and health care industry, including insurance companies, eight specific questions. None of the comments contained enough information for DEA to update the economic analysis. Therefore, the analysis and conclusions below remain unchanged from the analysis contained in the NPRM.

The economic, interagency, budgetary, legal, and policy implications of this rule have been examined and it has been determined to be a significant regulatory action under E.O. 12866, and therefore has been submitted to the Office of Management and Budget (OMB) for review.

As discussed above, the CARA was signed into law on July 22, 2016. One provision of the CARA amended the CSA to allow for the partial filling of prescriptions for schedule II controlled substances under certain conditions, providing flexibilities to prescribers and patients. Specifically, section 702(a) of the CARA amended 21 U.S.C. 829 by adding new subsection (f), which allows a pharmacist to partially fill a prescription for a schedule II controlled substance where requested by the prescribing practitioner or the patient. Subsection (f) further provides that for such partial filling to be lawful under the CSA, all of the following conditions must be satisfied: (1) The partial filling must not be prohibited by State law; (2) the prescription must be written and filled in accordance with the CSA, DEA regulations, and State law; and (3) the total quantity dispensed in all partial fillings must not exceed the total quantity prescribed. In addition, subsection (f) provides that the remaining portions of a partially filled prescription for a controlled substance in schedule II, if filled, must be filled no later than 30 days after the date on which the prescription is written, unless the prescription is issued as an emergency oral prescription, in which case the remaining portions, if filled, must be filled no later than 72 hours after it was issued.

When the prescriber requests the partial fill on the paper or electronic prescription, or after consultation with a pharmacist, the pharmacy's actions are straightforward. The pharmacist dispenses the prescription according to the prescriber's partial fill instructions and makes the required notations on the prescription, and the pharmacy maintains the required dispensing records. However, DEA considered three regulatory alternatives regarding the required notifications when the partial fill is at the request of the patient. DEA considered whether the pharmacist should: (1) Notify the prescribing practitioner or the prescribing practitioner's agent of the patient's request to partially fill the prescription, and obtain the prescribing practitioner's consent for the quantity; (2) notify the prescribing practitioner or the prescribing practitioner's agent of the patient's partial fill request, but not require the prescribing practitioner's consent; or (3) simply dispense the partial fill as requested without any notification or consent. As the pharmacist's requirement for notification or consent is the only difference between the alternatives, the alternatives analysis below only examines the estimated cost of notification or consent. A complete discussion of benefits and costs is described in the following section.

The first alternative would require the prescribing practitioner's consent for the quantity to be dispensed before the pharmacist dispenses a partial fill at the patient's request. Upon receiving a patient's request for a partial fill, the pharmacist would contact the prescribing practitioner or the prescribing practitioner's agent, and confirm that the prescribing practitioner concurs with the requested partial fill quantity. After confirmation, the pharmacist would dispense the partial fill and make the required notation on the prescription. The notation includes the method of notification ( e.g., telephone, email, voicemail) and the person notified.

DEA estimates obtaining consent would require six minutes from each of the parties involved: the pharmacist to request consent, the prescribing office to review the request and for the prescribing practitioner or practitioner's agent to give consent, and the patient to wait while consent is received. To estimate the cost, DEA used the following labor wage and employment cost rates from the U.S. Department of Labor, Bureau of Labor Statistics (BLS). The following occupations' median hourly wages were noted:  9

• Pharmacist requesting consent: 29-1051 Pharmacists, $60.64.

• Prescriber's representative to give consent: 43-6033 Medical Secretaries, $17.19. 10

• Patient: 00-0000 All Occupations, $18.54.

Additionally, a load of 42.7 percent for benefits was applied to the median hourly wages to obtain loaded median hourly wages below:  11

• Pharmacist requesting consent: 29-1051 Pharmacists, $86.53.

• Prescriber's representative to give consent: 43-6033 Medical Secretaries, $24.53.

• Patient: 00-0000 All Occupations, $26.51.

Therefore, the estimated cost of obtaining consent (six minutes per occurrence) would cost the pharmacy $8.65, the prescriber $2.45, and the patient $2.65, for a total $13.85 per occurrence.

While DEA does not have a strong basis to estimate the number of instances the patient will request partial filling of a prescription for schedule II control substance, in the Cost Savings discussion below, the estimated total prescriptions for potential partial filling is 36,375,279. DEA used the midpoint between 0 and 100 percent—half (18,187,640)—to estimate the cost savings. DEA does not know all the reasons a patient may request a partial fill, but believes a patient requesting a partial filling of a prescription for a schedule II controlled substance may seek a partial fill because: the patient is aware of the potential risks of excess opioids in the household, the patient does not want excess opioids in the household, the patient believes he or she will not need all the dosages prescribed, and there is no additional cost or logistical burden as a result of the partial fill. DEA further believes that patients are likely to follow the instructions of prescribers, and estimates only a small minority of the estimated 18,187,640 requests for partial fills will be at the request of the patient. For the purposes of this analysis, DEA assumes 10 percent, or 1,818,764 partial fills will be at the request of the patient. Applying the cost per occurrence to the number of occurrences, this alternative is estimated to cost pharmacies approximately $15.7 million per year for the pharmacists to obtain consent, prescribing practitioners approximately $4.5 million per year to give consent, and patients $4.8 million while waiting for the pharmacist to obtain consent from the prescribing practitioner or practitioner's agent for a total $25 million per year. The table below summarizes this calculation.

This alternative was not selected. It is contrary to the plain language of the statutory text, which allows a patient to request a partial fill without obtaining the practitioner's consent. Although this alternative ensures consideration of the partial fill by the prescribing practitioner, DEA believes this alternative is unnecessarily burdensome. While DEA does not have a basis to estimate the likelihood of the prescribing practitioner denying consent for partial fills, DEA assumes denials would be rare. The patient may request a partial fill for a variety of reasons, and a partial fill request does not necessarily mean that the remaining portions of the prescription will not be filled. Requiring consent prior to the pharmacist's dispensing the partial fill would be unnecessarily burdensome, and, thus, this alternative was not selected.

The second alternative would require notification to the prescribing practitioner or the prescribing practitioner's agent of the quantity dispensed upon the patient's request for the partial fill. In this scenario, the prescribing practitioner's consent for the partial fill would not be required. Instead, the pharmacist would partially fill the prescription based on the patient's request, notify the prescribing practitioner or the prescribing practitioner's agent of the quantity dispensed, and make the required notation on the prescription. The notation is the same method as for Alternative 1.

DEA estimates notifying the prescribing practitioner will require three minutes from each of the parties involved: the pharmacist to contact the prescribing office to give notice and the prescribing office to receive and review notice. Using the same BLS occupations and loaded median hourly wages as Alternative 1, the estimated cost of each notification (three minutes per occurrence) would cost the pharmacy $4.33 and the prescriber $1.23 for a total $5.56 per occurrence.

Applying the same estimate of 1,818,764 partial fills, as in Alternative 1, this alternative is estimated to cost pharmacies approximately $7.9 million per year for the pharmacists to give notice and prescribing practitioners approximately $2.2 million per year to receive and review notice. The table below summarizes this calculation.

This alternative was not selected. DEA believes that this alternative is also unnecessarily burdensome. Although this alternative would ensure that the prescribing practitioner is made aware of the partial filling of the prescription and could react to this information if needed, it would cause an additional compliance-burden on both the pharmacy and prescribing practitioner.

The third alternative would not require the consent of, or notification to, the prescribing practitioner described in Alternatives 1 or 2, respectively. In this alternative, the pharmacist would partially fill the prescription based on the patient's request and make the required notation on the prescription. This alternative results in no notification-related cost to the pharmacy or prescriber.

This alternative was selected. Although a partial fill at the request of the patient may represent a departure from the prescribing practitioner's dispensing instructions, this alternative is the least burdensome to the pharmacy, prescribing practitioner, and the patient. Additionally, a partial fill does not preclude the eventual dispensing of the full amount prescribed. Under this rule, patients requesting a partial fill would be entitled to request that the pharmacist fill the remainder of the prescription within a 30-day window. This alternative would result in no additional consent or notification-related costs and would not impose dispensing delays on patients requesting a partial fill. A further discussion of the benefits and costs of this alternative is described below. While the initial proposed alternative did not include the possibility of a parent or legal guardian making the request on behalf of a minor and a caregiver named in a medical power of attorney making the request on behalf of an adult patient, the inclusion of these provisions in the final rule does not change the advantages of this alternative or the economic analysis discussed below. When the patient is a minor or an adult patient who has a caregiver, the parent, legal guardian, or caregiver is often the person filling the prescription and may request partial filling with minimal economic impact.

This rule allows partial fills of prescriptions for schedule II controlled substances at the request of the patient (including the parent or legal guardian of a minor or the caregiver of an adult named in a medical power of attorney) or the prescribing practitioner, if not prohibited by State law. The rule also includes time limitations on filling the remaining portions of a partially filled prescription for a schedule II controlled substance, and additional provisions for how a practitioner may request that a prescription for a schedule II controlled substance be partially filled, and how a pharmacy must record the partial filling of a prescription for a schedule II controlled substance.

DEA examined the benefits, costs, and cost savings associated with this rule.

DEA does not know all the reasons a prescriber or patient might request a partial fill of a prescription. However, as discussed in the Cost Savings section below, a significant portion of filled opioid prescriptions go unused, leading to the excess opioids being kept by the patient that could end up being for improper use, diversion, or improper disposal. Partial filling is expected to reduce the quantity of unused schedule II controlled substances, which would decrease the risk of diversion, and the risk that patients or others may develop physical dependence or an addiction to prescribed scheduled II controlled substances.

The supply of unused drugs in U.S. households contributes to concerns related to opioids and illicit drug use. Keeping and storing unused medications in households poses several risks related to misuse, diversion, accidental overdose, and consumption of spoiled substances. 12 Many patients receive their first opioid prescription after a surgical procedure and frequently retain the majority of unused medication, which could potentially be sold illegally or misused by the patient. In addition, unused medication can be diverted and used by other members of the patient's household, friends of the patient, or sold. According to the National Institute on Drug Abuse, 21 to 29 percent of patients prescribed opioids for chronic pain misuse them, 13 between 9.1 and 12.2 percent prescribed opioids for chronic pain develop an opioid use disorder, 14 an estimated 4 to 6 percent who misuse prescription opioids transition to heroin, 15 16 17 and about 80 percent of people who use heroin first misused prescription opioids. 18 According to one journal article, “multiple studies have reported an increased risk of new persistent opioid use after prescription of opioids for acute pain in opioid naïve patients. Even patients who undergo relatively minor low-pain surgery are at increased risk of long term opioid use.”  19 According to the Substance Abuse and Mental Health Administration (SAMHSA), 47.2 percent of people who misused pain relievers in the past year obtained the last pain reliever they misused “from a friend or relative in some way ( i.e., being given them, buying them, or taking them without asking).”  20 Also, although opioid medications are effective in managing acute pain after surgery, even short-term use of opioids can lead to long-term dependence. 21

The total U.S. economic burden (healthcare costs, criminal justice costs, and lost productivity costs) of prescription opioid misuse in 2013 was estimated to be $78.5 billion, based on the 1.935 million Americans estimated to meet the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for opioid use disorder. 22 This economic burden equates to approximately $41,600 per person with opioid use disorder. 23 DEA estimates approximately $41,600 in societal benefit accrues each time we prevent an individual from developing opioid use disorder. This rule is expected to lower the prevalence of opioid misuse and thereby reduce rates of opioid addiction. While DEA has no basis to quantify the amount of misuse that will be prevented, DEA anticipates that reductions in opioid dispensing will reduce the amount of unused opioid medications in American homes, thereby reducing opportunities for medication sharing and other forms of diversion. This, in turn will have a real and significant benefit by reducing misuse and development of opioid use disorder.

This rule is estimated to lower the amount of schedule II medications dispensed and, therefore, expenditures on prescriptions. It is also expected to reduce the number of unused schedule II controlled substances requiring disposal. To quantify the cost savings, DEA estimated the cost of excess medicine and calculated the approximate percent cost savings opportunity that may be realized by this rule.

In 2017, 163,683,029 prescriptions for schedule II controlled substances were filled for “acute” pain, with a total retail cost of $11,807,297,373, or an average retail cost of $72.14 per prescription. 24 The prescription data includes a data field that indicates whether the condition being treated is “acute” or “chronic.” The figure excludes schedule II controlled substances generally prescribed for chronic conditions, i.e., amphetamine, lisdexamfetamine, methamphetamine, and methylphenidate. DEA believes prescriptions for “acute” conditions are more likely to be partially filled. Therefore, DEA estimates 163,683,029 prescriptions represent the total number of prescriptions that may be partially filled per year. However, many States have already passed laws or adopted regulations limiting the quantity of schedule II controlled substances that may be dispensed pursuant to a prescription. For example, in 2016, Massachusetts became the first state to pass a law to limit first time opioid prescriptions to seven days. 25 Since 2016, many other States have passed similar laws limiting the prescribing of opioids for acute pain. These limits generally range from a 3 to 14-day supply. 26 As of September 2019, 36 States have placed limits on the amount of opioids that can be prescribed by doctors. 27 The limits in five of those States apply only to Medicaid recipients, and two States have no pill or day limits, but require doctors to prescribe the lowest effective dose. 28 Based on review of state limits for prescribing of opioids, DEA estimates there are 34 states with pill or day limits in place, representing 68.7 percent of the U.S. population. 29 DEA believes partial fill provisions under this rule are likely to have an impact on the remaining states without opioid prescription limits, representing 31.3 percent of the U.S. population. Applying this percentage, DEA estimates 51,232,788 (31.3 percent) of the 163,683,029 total prescriptions may be partially filled. According to a 2017 study of post-surgical patients who were prescribed opioids, only 29 percent used the entire prescription, leaving 71 percent of post-surgical patients with excess opioids. 30 The study found that patients prescribed opioids after surgery consumed, on average, only 33 percent of the prescribed medication. 31 Based on that finding, DEA estimates 71 percent of patients will not use all controlled substance prescriptions. DEA therefore estimates that 36,375,279 (71 percent) of the estimated 51,232,788 prescriptions in states without controlled substance prescribing or dispensing limits will not be fully utilized, presenting an opportunity for cost savings from partial fills.

Assuming a typical partial fill request is for 50 percent of the prescription, and as discussed above, a patient is not likely to return to fill the remaining portion of the prescription, the estimated savings from the remaining unfilled portions is 50 percent of the average cost per prescription ($72.14) or $36.07. Multiplying the estimated savings per prescription of $36.07 by the number of prescriptions available for cost savings (36,375,279) results in $1,312,035,331 in potential cost savings per year. However, DEA does not have a basis to estimate the actual number or percentage of prescriptions for schedule II controlled substances issued in these states that will be partially filled, and therefore cannot estimate likely aggregate savings based on this methodology. For the purposes of this analysis, DEA estimates 50 percent of potential savings, or $656,028,165 (representing 18,187,640 partially filled prescriptions) will be realized as annual cost savings from reduced schedule II controlled substance dispensing. DEA does not have a basis to estimate the impact of this rule on payments to pharmacies, in terms of price per dosage units, co-pays, insurance reimbursements, etc., or who would realize the cost savings.

In addition to the cost savings from not dispensing remaining portions of partially filled prescriptions, DEA anticipates cost savings from the reduced need to dispose of unused medications. Patients dispose of unused drugs in a variety of ways, including throwing them in the trash, flushing them down the toilet, pouring them down the sink drain, taking them to the pharmacy or physician's office, or taking them to a drug take back site or event. In a two-phased study using a convenience sample in Southern California, researchers found that only 13 percent of people surveyed either disposed of their medications by taking them to the pharmacy or to the physician's office. 32 For the purpose of this analysis, DEA assumes that only 13 percent of people with leftover schedule II medications dispose of their unused medications in this way. It is likewise estimated that two-thirds of dispensed medications in the United States are unused by patients. 33 Based on DEA's assumption that a typical partial fill represents 50 percent of the prescription, and that the average partially filled prescription represents 67 pills, DEA estimates the average number of excess pills is 34 (50% × 67 pills) per full prescription filled. 34 To calculate the total cost savings for patients not needing to dispose of their unused schedule II controlled substances, DEA first multiplied the estimated number of partial fill prescriptions by the average disposal pill count to get a total of 618,379,760 pills (18,187,640 × 34). To estimate the number of pills being disposed of by patients through pharmacies, physician offices, or take back days, DEA multiplied the total number of pills (618,679,760) by 13 percent to get 80,389,369 pills. Using the average cost per disposal of $5.60/pound collected, 35 and the estimate of pound/pill of .0069, 36 the total cost savings for unused pills not needing to be disposed of is $3,106,245 (80,389,369 × $5.60 × .0069). The remaining 87 percent of pills that are not properly disposed of are assumed to be either thrown away in the trash (62.7 percent), flushed down the toilet (18 percent), disposed of in the sink (4.3 percent), not disposed of and stored (17.4 percent), and other (8 percent). 37 Therefore, the total annual cost savings of this rule is $659,134,410 ($656,028,165 + $3,106,245).

DEA estimates there is a cost to prescribers associated with the time burden of writing instructions for partial fill prescriptions.

Partial filling of a prescription for a schedule II controlled substance, pursuant to this rule, may be requested by the prescriber or the patient. The prescriber may request a partial fill by specifying the quantity to be dispensed in the partial filling on the face of the written prescription or in the pharmacy's electronic records, in the written record or the pharmacy's electronic records of the emergency oral prescription, or in the record of the electronic prescription record, along with other information required in 21 CFR 1306.05. A practitioner may authorize a partial fill at a date after which the prescription was issued, after consultation with a pharmacist. While any additional time to specify the quantity to be dispensed in the partial filling may be minimal, especially when viewed in relation to the entire duration of the medical interaction between the prescriber and the patient, DEA estimates each partial fill requested by the prescriber will require 10 additional seconds for the prescriber to specify the quantity to be dispensed. Based on BLS' mean hourly wage for “29-1060 Physicians and Surgeons” of $101.43 and a 42.7 percent load for benefits, the estimated loaded hourly wage for a prescriber is $144.74. 38 Therefore, the 10 additional seconds to specify the quantity to be dispensed equates to $0.40. 39 As discussed in the Cost Savings discussion above, DEA does not have a basis to estimate the percentage of the estimated 36,375,279 prescriptions per year available for partial filling that would be partially filled pursuant to this rule. Therefore, for the purposes of this analysis, DEA estimates the mid-point (50 percent), or 18,187,640 prescriptions per year, will be partially filled at the request of the prescriber at an annual cost of $7,275,056.

When a prescribing practitioner has properly specified his or her intent to partially fill a prescription for a schedule II controlled substance, this rule will require the pharmacist to record the partial filling in a manner similar to that required under the existing regulations for other circumstances. 40 Specifically, the dispensing pharmacist must make a notation of the quantity dispensed on the face of the written prescription or in the pharmacy's electronic records, in the written record or the pharmacy's electronic records of the emergency oral prescription, or in the record of the electronic prescription (similar to current requirements under 21 CFR 1306.13(a) when the pharmacist is unable to supply the full quantity called for in a prescription for a schedule II controlled substance). When the pharmacist partially fills a prescription, after the prescriber has conveyed this request in a consultation with a pharmacist in accordance with paragraph (b)(3), the pharmacist must note the following: “Authorized by Practitioner to Partial Fill,” the name of the practitioner, the date and time of the discussion, and the pharmacist's initials. Also, for each such partial filling (whether requested by the prescriber on the prescription or after consultation with the pharmacist), the pharmacy must maintain a record with the date of each dispensing, the name or initials of the individual who dispensed the substance, and all other information required by 21 CFR 1306.22(c) for prescription refills of schedule III and IV controlled substances. DEA believes the most common scenario will be that the partial fill information is entered into a computerized system, in an existing data field; then, an adhesive label with relevant information will be printed, and subsequently affixed to the prescription container. When partially filling a prescription for a schedule II controlled substance at the patient's request, the pharmacist must make the same notation on the prescription as when partially filling a prescription at the request of the prescribing practitioner, along with additional information indicating that the patient requested the partial fill. While DEA believes documenting the quantities dispensed for each filled prescription is a usual and ordinary activity for a pharmacist, DEA estimates that it may require 10 additional seconds for a pharmacist to record a partial fill, pursuant to this rule. Based on an estimated loaded median hourly rate of $86.53 for a pharmacist, from the alternatives analysis above, the 10 additional seconds to record partial fills equates to $0.24. 41 As discussed above, DEA does not have a basis to estimate the percentage of the estimated 36,375,279 prescriptions per year that will be partially filled. Therefore, for the purposes of this analysis, DEA estimates the mid-point (50 percent), or 18,187,640 prescriptions per year will be partially filled, requiring recording of the partial fill by the pharmacist at an annual cost of $4,365,034.

If a patient received a partial fill pursuant to this rule, and then returns to the pharmacy to receive another partial fill, or the remainder of the initial prescription, the pharmacist will require some additional time to fill the prescription. For example, if filling the remainder of the partial fill required 10 additional minutes, based on the estimated loaded median hourly rate of $86.53 for a pharmacist, that additional time will equate to a cost of $14.42. Additionally, there will be a similar cost to the patient to potentially make an additional trip to the pharmacy and waiting for the prescription to be filled. However, DEA estimates these additional interactions will be minimal. As discussed earlier in reference to the 2017 study of post-surgical patients who were prescribed opioids, 71 percent of patients in the study did not use the entire prescription, and on average the patients only used 33 percent of the prescribed opioids. If prescribers and patients randomly asked for partial fills, only a small minority of patients will return for the remainder of the prescription. However, DEA does not anticipate the request for partial fills, at the request of the prescriber or the patient, to be random. Rather, DEA anticipates prescribers will exercise professional judgment and foresight in determining when a partial fill is best suited. DEA does not believe a partial fill will be requested by the prescriber when the prescriber believes the patient is likely to need all of the prescribed medication. Furthermore, while this rule will permit patients to request partial fills, DEA believes patients are unlikely to request a partial fill. Rather, the patient will follow the prescriber's instruction, based on consultation between the prescriber and the patient. Therefore, DEA believes any increase in the number of patient-pharmacy interactions related to patient-requested partial fills and resulting burden would likely be de minimis. DEA estimates the total cost of this rule is $11,640,090 ($7,275,056 to prescribers and $4,365,034 to pharmacies) per year.

This analysis evaluates the economic impact of activities that were previously not permitted. Therefore, DEA does not have a strong basis to estimate the level of participation in these activities, including partial filling of prescriptions for schedule II controlled substances by prescribers and patients, and how insurance companies will react to these partial filling of prescriptions.

This analysis is highly sensitive to the percentage of prescriptions being partially filled, and the percentage of partially filled prescriptions with patients returning for remainder of the partially filled prescription.

For example, if prescribers and patients in States with no opioid prescription pill or day limits requested a partial fill of 50 percent of the prescription amount for all 71 percent of prescriptions where not all drugs are used, the estimated cost savings from not dispensing the full prescriptions increases to $1,312,035,331 (representing 36,375,279 partially filled prescriptions). Because DEA does not have a good basis to estimate the potential cost savings that will be realized, for the purposes of this analysis, DEA assumes the mid-point (50 percent), or $656,028,165 (representing 18,187,640 partially filled prescriptions) will be realized as cost savings from not dispensing excess schedule II controlled substances. An estimate of zero percent will result in zero cost savings. As the percentage of cases where partial fills are requested increases, the estimated cost savings increase proportionally.

DEA anticipates prescribers will exercise professional judgment and foresight in determining when a partial fill is best suited. DEA does not believe a partial fill will be requested by the prescriber when the prescriber believes the patient is likely to need all of the prescribed medicine, resulting in a minimal number of patients returning for the remainder of the partially filled prescription. Furthermore, while this rule will permit patients to request partial fills, DEA believes patients are unlikely to request a partial fill. Rather, the patient will follow the prescriber's instruction, based on consultation between the prescriber and the patient.

Finally, this analysis excluded any anticipated impact of this rule on payments to pharmacies, in terms of price per dosage units, co-pays, insurance reimbursements, etc., or who would realize the cost savings.

In summary, DEA estimates that the total cost savings of this rule will be $659 million per year, and the total cost will be $12 million per year, for a net cost savings of $647 million per year (rounded to the nearest million dollars) over the next five years. Due to the fluid nature of the national opioid crisis and legislative activity in State government, DEA believes using a five-year term for the analysis is reasonable. At a three percent discount rate, the net present value of the cost savings over a 5-year period is $2,965 million. At a seven percent discount rate, the present value of the cost savings is $2,655 million.

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

This rulemaking does not have federalism implications warranting the application of Executive Order 13132. This rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.

This rule does not have tribal implications warranting the application of Executive Order 13175. It does not have substantial direct effects on one or more Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.

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

This rule includes provisions regarding partial fill of prescriptions for schedule II controlled substances. This rule will allow partial fills of such prescriptions at the request of the patient or the prescribing practitioner, if not prohibited by State law. A request for partial fill can be made by the patient, a caregiver named in an adult patient's medical power of attorney, or parent or legal guardian of a minor patient. This rule also includes time limitations on filling the remaining portions of a partially filled prescription for a schedule II controlled substance and additional provisions for how a practitioner may request that a prescription for a schedule II controlled substance be partially filled, how a patient may request that a prescription for a schedule II controlled substance be partially filled, and how a pharmacy must record the partial filling of a prescription for a schedule II controlled substance. While not all practitioners may write prescriptions with partial fill instructions, and not all pharmacies may receive prescriptions for partial fill, these registrants (or entities that employ these registrants) will still be subject to the partial fill provisions contained in this rule.

This rule primarily affects prescribers of schedule II controlled substances and the pharmacies that fill those prescriptions. While prescribers are generally individual practitioners, for the purposes of this analysis, DEA includes industries that employ prescribers. In Table 3, DEA estimates the industries that will be affected by this rule, as described by the North American Industry Classification System (NAICS). This list is not intended to include an exhaustive list of all employers of prescribers of schedule II controlled substances, but rather a representation of primary industries that employ them.

The U.S. Census Bureau's Statistics of U.S. Businesses (SUSB) publishes the number of firms, employment, and revenue by firm size and industry. To estimate the number of small businesses affected, DEA compared the 2012 SUSB data, the most recent data available containing revenue by firm size and industry, 42 to the U.S. Small Business Administration (SBA) size standards. 43 DEA estimates a total 326,033 entities, of which 318,362 are small entities, will be affected by this rule. Table 4 details the number of entities, SBA size standard, and estimated number of small entities for each affected industry. 44

Partial filling of a prescription for a schedule II controlled substance, pursuant to this rule, may be requested by the prescriber or the patient. The prescriber may request a partial fill by specifying the quantity to be dispensed in the partial filling on the face of the written prescription, written record of the emergency oral prescription, or in the electronic prescription record, along with other information required in 21 CFR 1306.05. A practitioner may authorize a partial fill at a date after which the prescription was issued, after consultation with a pharmacist. While any additional time to specify the quantity to be dispensed in the partial filling may be minimal, especially when viewed in relation to the entire duration of the medical interaction between the prescriber and the patient, DEA estimates each partial fill requested by the prescriber will require 10 additional seconds for the prescriber to specify the quantity to be dispensed. As discussed in the Costs section above, based on BLS' mean hourly wage for “29-1060 Physicians and Surgeons” of $101.43 and a 42.7 percent load for benefits, the estimated loaded hourly wage for a prescriber is $144.74. Therefore, the 10 additional seconds to specify the quantity to be dispensed equates to $0.40. 45 As discussed in the Cost Savings discussion above, DEA does not have a basis to estimate the percentage of the estimated 36,375,279 prescriptions per year available for partial filling that would be partially filled pursuant to this rule. Therefore, for the purposes of this analysis, DEA estimates the mid-point (50 percent), or 18,187,640 prescriptions per year will be partially filled at the request of the prescriber at a cost of $7,275,056. This cost of $7,275,056 equates to an average of $24 per firm, excluding pharmacies. 46

When a prescribing practitioner has properly specified his or her intent to partially fill a prescription for a schedule II controlled substance, this rule will require the pharmacist to record the partial filling in a manner similar to that required under the existing regulations for other circumstances. 47 Specifically, the dispensing pharmacist must make a notation of the quantity dispensed on the face of the written prescription or in the pharmacy's electronic records, in the written record or the pharmacy's electronic records of the emergency oral prescription, or in the record of the electronic prescription (similar to current requirements under 21 CFR 1306.13(a) when the pharmacist is unable to supply the full quantity called for in the schedule II prescription). Also, for each such partial filling, the pharmacy must maintain a record with the date of each dispensing, the name or initials of the individual who dispensed the substance, and all other information required by 21 CFR 1306.22(c) for schedule III and IV prescription refills. DEA believes the most common scenario will be that the partial fill information is entered into a computerized system, in an existing data field; then, an adhesive label with relevant information will be printed, and subsequently affixed to the prescription container. When partially filling a prescription for a schedule II controlled substance at the patient's request, the pharmacist must make the same notation on the prescription as when partially filling a prescription at the request of the prescribing practitioner, along with additional information indicating that the patient requested the partial fill. While DEA believes documenting the quantities dispensed for each filled prescription is a usual and ordinary activity for a pharmacist, DEA estimates that it may require 10 additional seconds for the pharmacist to record a partial fill, pursuant to this rule. Based on an estimated loaded median hourly rate of $86.53 for a pharmacist, from the alternatives analysis above, the 10 additional seconds to record partial fills equates to $0.24. 48 As discussed in the Cost Savings section above, DEA does not have a basis to estimate the percentage of the estimated 36,375,279 prescriptions per year that will be partially filled. Therefore, for the purposes of this analysis, DEA estimates the mid-point (50 percent), or 18,187,640 prescriptions per year will be partially filled, requiring recording of the partial fill by the pharmacist at an annual cost of $4,365,034. This cost of $4,365,034 equates to an average of $232 per firm for pharmacies. 49

The average cost of $24 per firm for prescribers, and $232 per firm for pharmacies is a very high estimate for small entities, as small prescribing firms are expected to request less than an average number of partial fills per firm, and small pharmacies are expected to fill less than average partial fills per firm. Although these are high estimates, these costs were compared to the average annual revenue for the smallest of small entities. The average cost ranges from 0.009 percent of revenue for the smallest of small hospitals, and 0.487 percent for the smallest of small pharmacies. The table below summarizes this analysis for each of the industry codes.

After normalizing the cost for revenue size of the affected firms by dividing the total cost by the total revenue for the affected industry, the cost as percent of revenue is much lower. As an industry, the cost as percent of revenue is 0.0005 percent and 0.0018 percent for prescribing firms and pharmacies, respectively. These percentages represent all firms, including small firms. The table below summarizes the normalized cost as percentage of revenue.

If a patient received a partial fill pursuant to this rule, and then returns to the pharmacy to receive another partial fill, or the remainder of the initial prescription, the pharmacist will require some additional time to fill the prescription. For example, if filling the remainder of the partial fill required ten additional minutes, based on the estimated loaded median hourly rate of $86.53 for a pharmacist, that additional time will equate to a cost of $14.42. However, DEA estimates these additional interactions will be minimal. As discussed earlier in reference to the 2017 study of post-surgical patients who were prescribed opioids, 71 percent of patients in the study did not use the entire prescription, and on average the patients only used 33 percent of the prescribed opioids. If prescribers and patients randomly asked for partial fills, only a small minority of patients will return for the remainder of the prescription. However, DEA does not anticipate the request for partial fills, at the request of the prescriber or the patient, to be random. Rather, DEA anticipates prescribers will exercise professional judgement and foresight in determining when a partial fill is best suited. DEA does not believe a partial fill will be requested by the prescriber when the prescriber believes the patient is likely to need all of the prescribed medicine. Furthermore, while the rule would permit patients to request partial fills, DEA believes patients are unlikely to request a partial fill. Rather, the patient will follow the prescriber's instructions, based on consultation between the prescriber and the patient. Therefore, DEA believes any increase in the number of patient-pharmacy interactions related to patient-requested partial fills and resulting burden is de minimis.

Therefore, DEA's evaluation of economic impact by size category indicates that the rule will not have a significant economic impact on a substantial number of these small entities.

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., DEA has determined and certifies that this action will 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 the UMRA of 1995.

This rule is a major rule as defined by the Congressional Review Act, 5 U.S.C. 804. This rule will result in an annual effect on the economy of $100,000,000 or more; DEA estimates this rule will result in an annual cost savings of $659 million and a net cost savings of $647 million over five years. However, it will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. DEA has submitted a copy of this final rule to both Houses of Congress and to the Comptroller General.

Pursuant to section 3507(d) of the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3507(d)), DEA has identified the following collections of information related to this rule. This rule will create additional recordkeeping requirements for pharmacies regarding partial fills. A person is not required to respond to a collection of information unless it displays a valid OMB control number. Copies of existing information collections approved by OMB may be obtained at http://www.reginfo.gov/public/do/PRAMain.

Title: Recordkeeping Requirements for Partial Fills of Prescriptions for Schedule II Controlled Substances.

OMB Control Number: 1117-NEW.

DEA Form Number: N/A.

DEA is requiring pharmacies to create and maintain certain records relating to partial fills of prescriptions for schedule II controlled substances. When presented with a prescription for a schedule II controlled substance, on which the prescribing practitioner has properly specified his/her intent that the prescription be partially filled, the pharmacist will be required to record the partial filling in a manner similar to that required under the existing regulations (for other circumstances). 50 Specifically, upon each such partial filling requested by the prescribing practitioner, the dispensing pharmacist must make a notation of the quantity dispensed on the face of the written prescription, in the written record of the emergency oral prescription, or in the electronic prescription record (as is currently required under 21 CFR 1306.13(a) when the pharmacist is unable to supply the full quantity called for in the prescription). Where there is an oral consultation between the pharmacist and the prescribing practitioner after the prescription is issued, in which the prescribing practitioner conveys his or her request for a partial filling after issuing the prescription, the dispensing pharmacist must notate such discussion with the following: “Authorized by Practitioner to Partial Fill,” the name of the practitioner, the date and time of the discussion, and the pharmacist's initials. For electronic prescriptions, there needs to be an electronic prescription record and the record needs to be permanently attached to the electronic prescription. Also, for each such partial filling, the pharmacy will be required to maintain a record with the date of each dispensing, the name or initials of the individual who dispensed the substance, and all other information required by 21 CFR 1306.22(c) for schedule III and IV prescription refills. For electronic prescriptions specifically, pharmacy applications will need to allow required information pertaining to the quantity, date, and the dispenser to be linked to each electronic controlled substance prescription record (as currently required by 21 CFR 1311.205(b)(10)).

Upon partially filling a prescription for a schedule II controlled substance at the request of a patient, a caregiver named in an adult patient's medical power of attorney, or parent or legal guardian of a minor patient, dispensing pharmacists will need to make a notation of the following on the face of the written prescription, in the written record of the emergency oral prescription, or in the record of the electronic prescription: (1) “The [patient, parent or legal guardian of a minor patient, or caregiver of an adult patient named in a medical power of attorney, whichever is applicable)]requested partial fill on [date such request was made]” and (2) the quantity dispensed. In addition, for each such partial filling, the pharmacy will need to maintain a record of dispensing that includes the date of each dispensing, the name or initials of the individual who dispensed the substance, and all other information required by 21 CFR 1306.22(c) for schedule III and IV prescriptions. For electronic prescriptions specifically, such required information pertaining to the quantity dispensed, date dispensed, and the dispenser will need to be linked to each electronic controlled substance prescription record.

DEA estimates the following number of respondents and burden associated with this collection of information:

• Number of respondents: 68,676.

• Frequency of response: Per occurrence (264.83255 per year, calculated).

• Number of responses: 18,187,640 per year.

• Burden per response: 0.002777778 hour (10 seconds).

• Total annual hour burden: 50,521 hours.

The activities described in this information collection are usual and ordinary business activities and no additional cost is anticipated.

If you need additional information, please contact the Regulatory Drafting and Policy Support Section (DPW), Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 776-2265.

Any additional comments on this collection of information may be sent in writing to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ, Washington, DC 20503. Please state that your comments refer to RIN 1117-AB45/Docket No. DEA-469.

This document of the Drug Enforcement Administration was signed on July 18, 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, DEA amends part 1306 as follows:

I. Background A. ONRR Regulations

ONRR performs oil, gas, coal, solid minerals, and geothermal minerals revenue management responsibilities for the Secretary of the Interior (“Secretary”). See U.S. Department of the Interior Departmental Manual (“Departmental Manual”), 112 DM 34.1 (Sept. 9, 2020). ONRR regulations are published at 30 CFR Chapter XII. The regulations contain 18 parts addressing different aspects of minerals revenue management. This final rule covers Part 1202—Royalties and Part 1206—Product Valuation.

On July 1, 2016, ONRR published the Consolidated Federal Oil & Gas and Federal & Indian Coal Valuation Reform Rule (“2016 Valuation Rule”). See 81 FR 43338-43402. The 2016 Valuation Rule revised the Federal oil and gas and Federal and Indian coal sections of Parts 1202 and 1206, effective January 1, 2017. Id. at 43338.

On June 12, 2019, industry members and trade organizations filed a lawsuit in the United States District Court for the District of Wyoming to challenge the 2016 Valuation Rule. See Petition for Review, Cloud Peak Energy Inc. v. U.S. Dep't of the Interior, No. 19-CV-120-SWS, ECF No. 1.

On September 8, 2021, the District Court issued an Order Upholding in Part and Reversing in Part the 2016 Valuation Rule (“the Order”). Cloud Peak Energy Inc. v. U.S. Dep't of the Interior, 559 F. Supp. 3d 1203 (D. Wyo. 2021). The Order states that “the new valuation methods for [F]ederal and Indian coal must be vacated.” Id. at 1208. It further states that “[a]s the coal-specific 2016 Valuation Rule provisions have never been put into practice (due to the earlier preliminary injunction), the pre-2016 valuation methodologies for [F]ederal and Indian coal shall continue to govern.” Id. at 1226. The District Court's judgment (“District Court's Judgment”) was entered the same day and states: “the [F]ederal and Indian coal valuation provisions of the 2016 Valuation Rule are hereby set aside and vacated.” Id. Because no party sought review of the portions of the District Court's Order and Judgment applicable to Federal and Indian coal, the District Court's vacatur of the Federal and Indian coal valuation provisions is final. Accordingly, to ensure the rules applicable to Federal and Indian coal, as determined by the District Court, appear in the Code of Federal Regulations, ONRR must publish a final rule containing the coal valuation regulations in effect before the 2016 Valuation Rule.

Prior to the 2016 Valuation Rule, Subpart F of Part 1202 contained only § 1202.250, concerning overriding royalty interests. Part 1206, Subpart F, 1206.253, and Part 1206, Subpart J, Section 1206.452 addressed what coal is subject to Federal or Indian royalties. The 2016 Valuation Rule consolidated and moved §§ 1206.253 and 1206.452 to Part 1202, Subpart F, § 1202.251. See 81 FR 43369.

This final rule recodifies Part 1202 Subpart F—Coal as it appeared prior to the 2016 Valuation Rule. As further discussed below, this final rule also recodifies Part 1206, Subparts F and J, including §§ 1206.253 and 1206.452. This effectively removes § 1202.251 from Part 1202 and returns the regulatory language addressing what coal is subject to royalties to Part 1206.

Prior to the 2016 Valuation Rule, Part 1206 contained Subparts F—Federal Coal and J—Indian Coal. These Subparts set forth various provisions for the valuation of Federal and Indian Coal, including definition sections at §§ 1206.251 and 1206.451. The 2016 Valuation Rule retained but substantially revised Subparts F and J. See 81 FR 43369-43402. This final rule recodifies the prior Subparts F and J, including the definition sections at §§ 1206.251 and 1206.451, as those Subparts appeared prior to the 2016 Valuation Rule.

Prior to the 2016 Valuation Rule, Part 1206, Subpart A—General Provisions contained only § 1206.10, which discussed information collection requirements. Additionally, Part 1206, Subparts C—Federal Oil, D—Federal Gas, F—Federal Coal, and J—Indian Coal contained definition sections at §§ 1206.101, 1206.151, 1206.251 and 1206.451, respectively.

The 2016 Valuation Rule changed the title of Part 1206, Subpart A to “General Provisions and Definitions,” added § 1206.20 titled “What Definitions Apply to this Part?,” and consolidated and moved the definitions from §§ 1206.101, 1206.151, 1206.251, and 1206.451 to § 1206.20. See 81 FR 43369-43372. Some of these consolidated definitions contain, in part, language only applicable to coal. For example, after broadly defining the term “lessee,” § 1206.20 clarified that “lessee” also includes “[i]n the case of leases for Indian coal or Federal coal, an operator, payor, or other person with no lease interest who makes payments on the lessee's behalf.”

Because the District Court vacated only the Federal and Indian coal valuation provisions of the 2016 Valuation Rule, this final rule retains, in part, § 1206.20. To implement the District Court's Order and Judgment, however, this final rule removes from § 1206.20 the definitions of the following coal-specific terms: “Ad valorem lease,” “Coal,” “Coal cooperative,” “Coal washing,” “Region,” “Short ton,” “Tonnage,” and “Washing allowance.” This final rule further revises the definitions of the following terms in § 1206.20 to remove coal-specific language: “Gross proceeds,” “Lessee,” “Marketable condition,” “Net Output,” “Sale,” and “Transportation allowance.”

Prior to the 2016 Valuation Rule, Part 1206, Subparts F and J used, but did not define, the terms “affiliate,” “designee,” “lease products,” “misconduct,” “payor,” “processing,” and “sale.” The 2016 Valuation Rule defined these terms in § 1206.20. See 81 FR 43369-43372. Because other Subparts of Part 1206 also use these terms, this final rule leaves these definitions in § 1206.20. To recodify the version of the Federal and Indian coal valuation provisions in effect prior to the 2016 Valuation Rule, however, this final rule adds introductory text to §§ 1206.20, 1206.251 and 1206.451 stating that the definitions in § 1206.20 do not apply to Subparts F and J, and that the definitions in §§ 1206.251 and 1206.451 apply to their respective subparts.

ONRR finds good cause to issue this final rule without notice and opportunity for public comment under 5 U.S.C. 553(b)(B). The publication of this final rule was necessitated by the District Court's Order and Judgment that vacated the Federal and Indian coal valuation provisions of the 2016 Valuation Rule. Because ONRR is acting to comply with a final court order, public comment is unnecessary.

Additionally, a 30-day period between publication of a final rule and its effective date is not required by 5 U.S.C. 553(d) because the District Court's Order and Judgment found that pre-2016 valuation provisions shall continue to govern Federal and Indian coal.

Executive Order (“E.O.”) 12866 provides that the Office of Information and Regulatory Affairs (“OIRA”) of the Office of Management and Budget (“OMB”) will review all significant rules. This final rule is not significant because it does not change the law in any way and only publishes the current law as established by the District Court's Order and Judgment.

E.O. 14094 reaffirms the principles of E.O. 12866 and E.O. 13563 and states that regulatory analysis should facilitate agency efforts to develop regulations that serve the public interest, advance statutory objectives, and are consistent with E.O. 12866, E.O. 13563, and the Presidential Memorandum of January 20, 2021 (Modernizing Regulatory Review). Regulatory analysis, as practicable and appropriate, shall recognize distributive impacts and equity, to the extent permitted by law. E.O 13563 further emphasizes those 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. ONRR has demonstrated, however, good cause to issue this final rule without notice and opportunity for public comment pursuant to 5 U.S.C. 553(b)(B) because this final rule is published to comply with the District Court's Order and Judgment.

The Department of the Interior (“the Department”) certified that the 2016 Valuation Rule did not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). See 81 FR 43367. Thus, a Regulatory Flexibility Analysis and a Small Entity Compliance Guide were not required. Similarly, the republication of the coal valuation regulations that were in effect prior to the 2016 Valuation Rule does not require a Regulatory Flexibility Analysis and Small Entity Compliance Guide.

The republication of the coal valuation regulations in effect prior to the 2016 Valuation Rule is not considered a major rule under the Congressional Review Act (5 U.S.C. 804(2)). This final rule:

(1) Does not have an annual effect on the economy of $100 million or more.

(2) Does not cause a major increase in costs or prices for consumers; individual industries; Federal, State, or local government agencies; or geographic regions.

(3) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

The republication of the Federal and Indian coal valuation provisions in effect prior to the 2016 Valuation Rule does not impose an unfunded mandate on State, local, or Tribal governments or the private sector of more than $100 million per year. This final rule does not have a significant or unique effect on State, local, or Tribal governments or the private sector. Therefore, ONRR is not required to provide a statement under the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ) because this final rule is not an unfunded mandate.

Under the criteria in E.O. 12630, section 2, this final rule has no significant takings implications. Hence, this final rule does not impose conditions or limitations on the use of any private property and does not require a Takings Implication Assessment.

Under the criteria in E.O. 13132, section 1, this final rule does not have sufficient Federalism implications to warrant the preparation of a Federalism summary impact statement. This final rule does not impose administrative costs on States or local governments and does not substantially and directly affect the relationship between the Federal and State governments. Thus, a Federalism summary impact statement is not required.

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

(1) Meets the criteria of section 3(a), which requires that ONRR review all regulations to eliminate errors and ambiguity to minimize litigation.

(2) Meets the criteria of section 3(b)(2), which requires that all regulations be written in clear language using clear legal standards.

ONRR strives to strengthen its government-to-government relationship with Indian Tribes through a commitment to consultation with Indian Tribes and in recognition of their right to self-governance and Tribal sovereignty. ONRR evaluated this final rule and the criteria in E.O. 13175 and determined that the final rule will not have substantial direct effects on Federally recognized Indian Tribes. Thus, consultation under ONRR's Tribal consultation policy is not required.

This final rule does not contain any new information collection requirements or meet the definition of “collection of information” under 44 U.S.C. 3502(3). A submission to OMB under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ) is not required.

This final rule does 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 this final rule implements a court order to vacate the 2016 Valuation Rule's Federal and Indian coal amendments. See 43 CFR 46.210(i) and the Departmental Manual, 516 DM 15.4.D. ONRR determined that this final rule does not involve any of the extraordinary circumstances under 43 CFR 46.215 that would require further analysis under NEPA. The procedural changes resulting from these amendments have no consequence with respect to the physical environment. This final rule will not alter in any material way natural resource exploration, production, or transportation.

This final rule is not a significant energy action under the definition in E.O. 13211 and, therefore does not require a Statement of Energy Effects.

ONRR is required by E.O. 12866 (section 1(b)(12)), E.O. 12988 (section 3(b)(1)(B)), and E.O. 13563 (section 1(a)), and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule ONRR publishes must:

(1) Be logically organized.

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

(3) Use common, everyday words and clear language rather than jargon.

(4) Be divided into short sections and sentences.

(5) Use lists and tables wherever possible.

If you feel that ONRR has not met these requirements, send your comments to ONRR_RegulationsMailbox@onrr.gov . To guide ONRR in developing future changes to this final rule, your remarks should be as specific as possible. For example, you should tell ONRR the numbers of the sections or paragraphs that are not clearly written, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

For the reasons discussed in the preamble and to comply with the District Court's Order and Judgment, ONRR amends 30 CFR parts 1202 and 1206 as set forth below:

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because a temporary safety zone must be established immediately to protect personnel, vessels, and the marine environment from potential hazards created by the use of explosives for the implosion of the power plant and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule. It is impracticable to publish an NPRM because we must establish this safety zone by July 21, 2023.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable because immediate action is needed to respond to the potential safety hazards associated the use of explosives for the implosion of the Lansing Power Station.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Sector Upper Mississippi River (COTP) has determined that potential hazards associated with the use of explosions for the implosion of the Lansing Power Plant will be a safety concern for anyone operating or transiting within the Upper Mississippi River from MM 660.5 through 659.5. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the implosion is being conducted.

The Lansing Power Plant, located between MM 660.5 and 659.5, will be imploded using explosives. The planned dates of implosion are July 22, 2023, and August 5, 2023. The safety zone is designed to protect waterway users until work is complete.

No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard (USCG) assigned to units under the operational control of USCG Sector Upper Mississippi River. To seek permission to enter, contact the COTP or a designated representative via VHF-FM channel 16, or through USCG Sector Upper Mississippi River at 314-269-2332. Persons and vessels permitted to enter the safety zone must comply with all lawful orders or directions issued by the COTP or designated representative. The COTP or a designated representative will inform the public of the effective period for the safety zone as well as any changes in the dates and times of enforcement, as well as reductions in the size of the safety zone through Local Notice to Mariners (LNMs), Broadcast Notices to Mariners (BNMs), and/or Safety Marine Information Broadcast (SMIB), as appropriate.

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

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

This regulatory action determination is based on a safety zone located on the Upper Mississippi River at MM 660.5-659.5, near Lansing, IA. The Safety Zone is expected to be active only during the implosion events, until August 15, 2023.

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

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator because the zone will be enforced only when work is being conducted.

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone encompassing the width of the Upper Mississippi River at MM 660.5-659.5. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because The COTP was notified of the impending arrival of the M/V ZHEN HUA 23 less than 30 days in advance and immediate action is needed to respond to the potential safety hazards associated with the transfer of large cranes within the Port of Los Angeles. It is impracticable to publish an NPRM because we must establish this safety zone by July 20, 2023.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable and contrary to the public interest because immediate action is needed to ensure the safety of persons, vessels, and the marine environment in the vicinity of the M/V ZHEN HUA 23 while conducting oversized cargo transfer operations at FMS, Pier LA 302, within the Port of Los Angeles.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The COTP Los Angeles-Long Beach has determined that potential hazards associated with the movement of ship to shore crane transfer operations will be a safety concern for anyone within a 500-foot radius of the M/V ZHEN HUA 23 during its transit to FMS, Pier LA 302, while the vessel is within the Port of Los Angeles and the waters inside the Federal breakwaters bounding San Pedro Bay or on the waters within three nautical miles seaward of the Federal breakwaters, respectively. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the vessel offloads quay cranes in the Port of Los Angeles.

This rule establishes a safety zone from 7 a.m. July 20, 2023 to 12 p.m. on July 22, 2023 during the transit of the M/V ZEN HUA 23 to berth. While the M/V ZHEN HUA 23 is within the Port of Los Angeles and the waters inside the Federal breakwaters bounding San Pedro Bay or on the waters within three nautical miles seaward of the Federal breakwaters, respectively, the safety zone will encompass the navigable waters around and under the vessel, from surface to bottom, within a circle formed by connecting all points 500-feet out from the vessel. The safety zone is needed to protect personnel, mariners, and vessels from hazards associated with ship to shore gantry crane arms which will extend more than 200 feet out from the transiting vessel. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the transfer operations are active.

No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. Sector Los Angeles-Long Beach may be contacted on VHF-FM Channel 16 or (310) 521-3801. The marine public will be notified of the safety zone via Broadcast Notice to Mariners.

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

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

This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. This rule impacts an area of 500-feet surrounding a cargo vessel solely for its transit to FMS, Pier LA 302, during the month of July 2023. This safety zone impacts a 500-foot-radius area of the Port of Los Angeles and the waters inside the Federal breakwaters bounding San Pedro Bay or on the waters within three nautical miles seaward of the Federal breakwaters, respectively for a limited duration. While the safety zone encompasses a three-day period to account for uncertain transit delays of the M/V ZHEN HUA 23, the safety zone will only be enforced for the duration of the vessel's inbound transit to FMS, Pier LA 302. The transit is expected to last less than 5 hours, and that period will be announced via Broadcast Notice to Mariners. Vessel traffic will be able to safely transit around this safety zone, which will impact a small, designated area of the San Pedro Bay, Los Angeles, CA.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone encompassing an area extending 500-feet out from a cargo vessel in vicinity of Fenix Marine Services and will last only for the inbound transit. It is categorically excluded from further review under paragraph L60 (a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

39 CFR 233.2 gives Postal Inspection Service the authority to issue monetary rewards for certain types of offenses against the United States Code. 39 CFR 233.2 will be changed to reflect an increase in monetary reward amounts and a reclassification of the types of offenses for which rewards can be issued. Specifically, the rule change will reclassify offenses by categories which were previously classified by monetary amount. Reward amounts for the recategorized offenses will be increased to reflect current valuations and severity of such offenses.

These changes will be mirrored in the publication of the Postal Service's Poster 296, embedded in the footnote of 39 CFR 233.2, which in turn, will facilitate a better understanding of the Postal Service's reward system to the general public. Such changes will further enhance any investigation of the listed offenses and provide a deterrent incentive to the commission of crimes against the Postal Service. Additionally, the new rule adds a reward for mail fraud offenses. These changes will give the Chief Postal Inspector the discretion to authorize rewards exceeding Poster 296 amounts, and to offer rewards for other offenses not specifically listed in Poster 296.

The Postal Service is publishing a final rule to update Postal Service regulations regarding the 39 CFR part 233.2, Circulars and Rewards. The circumstances which created the need for the update were as follows: (1) 39 CFR 233.2 was published as a final rule on March 29, 2004; (2) since the publication of 39 CFR 233.2, no updates have been made; (3) changes to Poster 296 will be simultaneously made with this rule change to increase reward amounts and to recategorize the types of offenses for which rewards can be offered (4) an update to 39 CFR 233.2 is required to ensure its consistency to the current Poster 296 changes.

We will publish an appropriate amendment to 39 CFR part 223 to reflect these changes.

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

On February 15, 2023, the EPA proposed to determine that the West Pinal County nonattainment area failed to attain the 1987 24-hour PM 10 NAAQS by its December 31, 2022 “Serious” area attainment date. 1 For a PM 10 nonattainment area classified as Serious under the CAA, such as the West Pinal County area, section 188(c)(2) of the CAA states that the area's attainment date is “as expeditiously as practicable but no later than the end of the tenth calendar year beginning after the area's designation as nonattainment.”

I. General Information A. How is this Federal Register document organized?

The information presented in this preamble is organized as follows:

Entities potentially directly affected by this rulemaking include federal, state, local, and tribal air pollution control agencies that administer title V operating permit programs. 1 Entities potentially indirectly affected by this rulemaking include owners and operators of emissions sources in all industry groups who hold or apply for title V operating permits.

In addition to being available in the docket, an electronic copy of this Federal Register document will be posted at https://www.epa.gov/title-v-operating-permits/current-regulations-and-regulatory-actions.

The EPA has promulgated permitting regulations applicable to the operation of major and certain other sources of air pollutants under title V of the CAA. These regulations are codified in 40 CFR parts 70 and 71, which contain the requirements for state operating permit programs and the federal operating permit program, respectively. These regulations contained identical provisions establishing an affirmative defense that sources could assert in enforcement actions brought for noncompliance with technology-based emission limitations caused by specific emergency circumstances. These “emergency” provisions were located at 40 CFR 70.6(g) and 71.6(g).

In this action, the EPA is removing the emergency affirmative defense provisions in 40 CFR 70.6(g) and 71.6(g) because they are inconsistent with the EPA's current interpretation of the enforcement structure of the CAA, in light of prior court decisions from the U.S. Court of Appeals for the D.C. Circuit—primarily the court's 2014 decision in NRDC v. EPA, 749 F.3d 1055 (D.C. Cir. 2014). The removal of these provisions is also consistent with other recent EPA actions involving affirmative defenses  2 and will harmonize the EPA's treatment of affirmative defenses across different CAA programs. The EPA previously provided background on the title V emergency provisions and articulated its justification for this action in the preamble to the 2016 and 2022 proposed rules preceding this final rule. 3 4 Section III. of this document responds to significant comments we received on those proposals and provides additional information in support of this final rule.

As a consequence of the EPA's action to remove these provisions from 40 CFR 70.6(g), it will be necessary for any states that have adopted similar affirmative defense provisions in their part 70 operating permit programs to revise their part 70 programs to remove these provisions. In addition, individual operating permits that contain title V affirmative defenses based on 40 CFR 70.6(g) or similar state regulations will eventually need to be revised. The EPA discussed its expectations concerning how states will implement this rule in section V. of the preamble to the 2016 proposed rule and also requested comments on some of the aspects discussed. Additional information regarding these implementation considerations and the EPA's response to relevant comments received on these issues are included in section IV. of this document.

EPA expects that program revisions to remove the title V emergency defense provisions from state operating permit programs will include, at minimum: (1) a redline document identifying the state's proposed revision to its part 70 program rules; (2) a brief statement of the legal authority authorizing the revision; and (3) a schedule and description of the state's plans to remove affirmative defense provisions from individual operating permits. The EPA encourages states to consult with their respective EPA regional offices on the specific contents of their revision submittal packages.

In general, any impermissible affirmative defense provisions within individual operating permits that are based on a title V authority and that apply to federally-enforceable requirements will need to be removed. As explained in the 2016 proposal, the EPA expects that any necessary permit changes should occur in the ordinary course of business, such as during periodic permit renewals or revisions. At the latest, states would be expected to remove affirmative defense provisions from individual permits by the next periodic permit renewal that occurs following either (1) the effective date of this rule (for permit terms based on 40 CFR 70.6(g) or 71.6(g)) or (2) the EPA's approval of state program revisions (for permit terms based on a state affirmative defense provision).

This section contains the EPA's response to significant comments regarding the EPA's proposed action to remove 40 CFR 70.6(g) and 71.6(g) and provides the EPA's justification for this final action. Comments and the EPA's responses are divided into four general topic areas: section III.A. of this document discusses the legal basis for this action in light of the NRDC decision; section III.B. discusses issues related to exemptions from emission limitations and the D.C. Circuit's 2008 decision in Sierra Club v. EPA, 551 F.3d 1019 (D.C. Cir. 2008); section III.C. discusses other legal and policy considerations; and section III.D. discusses various issues involving the consequences of removing the title V emergency affirmative defense provisions from operating permit programs, focusing primarily on the impact on sources.

The following subsections address comments received concerning the NRDC decision and the EPA's legal basis for this action. Subsections III.A.1. and III.A.2. of this document address general comments either supporting or opposing the EPA's interpretation of the NRDC decision. Subsection III.A.3. addresses specific comments concerning the extent to which the NRDC decision should apply beyond the context of citizen-suit enforcement under CAA section 304, and how the decision should inform the EPA's treatment of affirmative defenses in the context of EPA-initiated judicial enforcement and administrative penalty actions under CAA sections 113(b) and (d). Specific comments that discuss the relationship between the NRDC decision and prior case law are presented in section III.C.2. of this document.

Comment: Multiple environmental and state commenters supported the EPA's view that, in light of NRDC, the title V emergency affirmative defense provisions should be removed because they impermissibly limit the authority of courts to decide appropriate penalties in private civil suits. Some commenters claimed that the EPA lacks the authority to create such provisions. Other state and industry commenters acknowledged that the NRDC decision limits the EPA's discretion to retain affirmative defense provisions, either altogether or in certain contexts. Commenters argued that when Congress wanted to limit the authority of courts, to allow an affirmative defense or to permit an extrajudicial entity to modify penalties, it did so expressly, citing CAA sections 113(e)(1), 113(c)(5)(C)-(D), and 113(d)(2)(B).

Some commenters asserted that the NRDC decision applies beyond the specific context of CAA section 112 standards because the court's rationale was based on CAA sections 113 and 304, not CAA section 112. Therefore, commenters concluded that the prohibition on affirmative defenses applies to any citizen-enforceable emission standards or limitations under the Act. Commenters claimed that NRDC is applicable to the title V emergency affirmative defense provisions because, like the hazardous air pollution standards at issue in NRDC, all other emission standards contained in title V operating permits are enforceable under CAA section 304. Some commenters further asserted that the fundamental principles underlying the NRDC decision with respect to affirmative defenses were reinforced by the D.C. Circuit's 2016 decision in U.S. Sugar v. EPA. 5

Response: The EPA generally agrees with commenters supporting the legal basis for this action to remove the emergency affirmative defense provisions from the EPA's title V regulations. The EPA previously explained its legal rationale for this action in the 2016 and 2022 proposed rules. 6 Here, the EPA reiterates some of the primary legal principles guiding this current action.

The EPA's current interpretation of the CAA with respect to affirmative defenses is informed by the D.C. Circuit's NRDC decision. In NRDC, the D.C. Circuit vacated affirmative defense provisions contained in the EPA's National Emission Standards for Hazardous Air Pollutants (NESHAP) for the portland cement industry, promulgated under CAA section 112. The D.C. Circuit concluded that the EPA lacked the authority to create these affirmative defense provisions because they contradicted fundamental requirements of the Act concerning the authority of courts to decide whether to assess civil penalties in CAA enforcement suits. Importantly, the court's decision did not turn upon any specific provisions of CAA section 112, but rather on the provisions of CAA sections 113 and 304. These provisions pertain to enforcement of a wide variety of CAA requirements beyond section 112 standards, including enforcement of emission limits contained in title V permits. Thus, the mere fact that the court addressed the legality of an affirmative defense provision in the context of a section 112 NESHAP does not mean that the court's interpretation of sections 113 and 304 does not also apply more broadly. To the contrary, the EPA sees no reason why the logic of the court concerning sections 113 and 304 would not apply to the title V emergency affirmative defense provisions, as well.

Notably, in 2016, the D.C. Circuit reaffirmed its NRDC opinion concerning affirmative defenses. In U.S. Sugar, the D.C. Circuit addressed various challenges to rules promulgated in 2011, including challenges urging that—in the absence of affirmative defenses—the EPA was required to address periods of malfunction in setting the applicable standards. Discussing NRDC, the U.S. Sugar opinion stated that the affirmative defense provision at issue in the NRDC case was “an impermissible intrusion on the judiciary's role.”  7 The fact that the title V emergency affirmative defenses arguably apply more broadly ( i.e., to potentially numerous technology-based emission limits developed under multiple CAA program areas) than the affirmative defense at issue in NRDC potentially makes it even more intrusive on the judiciary's role.

In light of the NRDC decision and the EPA's reevaluation of the CAA, the EPA interprets the enforcement provisions in sections 113 and 304 of the CAA to preclude affirmative defense provisions that would operate to limit a court's authority or discretion to determine the appropriate remedy in an enforcement action. Section 304(a) grants the federal district courts jurisdiction to determine liability and to impose penalties in enforcement suits brought by citizens. Similarly, section 113(b) grants the federal district courts jurisdiction, in enforcement actions brought by the U.S. Department of Justice (DOJ) on behalf of the EPA, to determine liability and to impose remedies of various kinds, including injunctive relief and monetary penalties. These grants of jurisdiction come directly from Congress, and the EPA is not authorized to alter or eliminate this authority. With respect to monetary penalties, CAA section 113(e) lists various factors that courts and the EPA shall consider in the event of judicial or administrative enforcement for violations of CAA requirements, including title V permit conditions. Because Congress has already given federal courts the authority to determine what penalties are appropriate in the event of judicial enforcement for a violation of a title V permit provision, neither the EPA nor states should be able to alter or eliminate that authority by superimposing restrictions on the authority and discretion granted by Congress to the courts. Affirmative defense provisions by their nature limit or eliminate the authority of federal courts to determine liability or to impose remedies through considerations that differ from the explicit grants of authority in section 113(b) and section 113(e). Therefore, these provisions are not appropriate under the CAA, no matter what type of event they apply to, what criteria they contain, or what forms of remedy they purport to limit or eliminate. The emergency affirmative defense provisions that the EPA is removing from 40 CFR 70.6(g) and 71.6(g) purported to interfere with the authority of the courts to determine whether and to what extent penalties or other remedies were appropriate in judicial enforcement actions, conflicted with the holding of NRDC, and were contrary to the enforcement structure of the CAA. Thus, the EPA has determined that these provisions should be removed from the EPA's regulations.

Section IV.A. of this document contains additional information concerning the need for states to submit program revisions to remove similar title V affirmative defense provisions from EPA-approved state operating permit programs, and to remove similar provisions from individual operating permits.

Comment: Some commenters stated that the D.C. Circuit's decision in NRDC v. EPA was limited to the particular facts or circumstances of that case and that the EPA's reliance on the decision to support removal of the title V emergency affirmative defense provisions is an incorrect extension or misapplication of the decision. Commenters generally claimed that the EPA should not apply the NRDC court's ruling to every corner of the CAA, including to the title V affirmative defense provisions within the EPA's regulations and state operating permit programs. Some commenters stated that the NRDC decision only invalidated an affirmative defense associated with a NESHAP issued in accordance with CAA section 112, and that the decision should be limited to those standards (or, even, to the specific standards for portland cement plants subject to that litigation). Commenters alleged that the D.C. Circuit provided no language to broaden its ruling. Some commenters focused on the specific statutory mandates involved in establishing section 112 standards. One commenter alleged that the D.C. Circuit held that once a section 112 standard is promulgated and established for all operating modes, no “gap” remains for the EPA to create an affirmative defense.

Other commenters focused on the differences between title V permits and the section 112 standards that the NRDC court considered. These commenters explained that title V permits contain numerous different underlying standards applicable to a source (such as standards developed under a State Implementation Plan (SIP) or under New Source Review Programs), as well as additional procedural and monitoring, reporting, and recordkeeping requirements. Thus, one commenter asserted that enforcement of title V permit requirements differs from enforcement of specific section 112 emission limits, and that the D.C. Circuit's logic prohibiting affirmative defenses does not apply to other types of applicable requirements in a title V permit, including substantive standards as well as administrative or procedural requirements.

Some commenters attempted to distinguish the title V emergency affirmative defense, which at least one commenter characterized as a defense to “liability” or “noncompliance,” from the affirmative defense to “civil penalties” at issue in the NRDC case. One commenter claimed that the NRDC decision was based on the assumption that excess emissions automatically result in a violation of a section 112 standard, and therefore that the D.C. Circuit only addressed how affirmative defense provisions affect a court's authority to determine appropriate remedies after an actionable violation has been identified. Multiple commenters asserted that neither CAA section 113 nor the NRDC case speak to provisions that define when a violation has occurred. Some commenters also asserted that the NRDC decision involved an affirmative defense for malfunctions, not emergencies, and concluded that the EPA should not apply the decision to the title V emergency affirmative defense because malfunctions are not similar in nature to emergencies.

Some commenters also claimed more generally that the title V affirmative defense provisions do not impair a court's ability to decide whether a source has met its burden of demonstrating that an emergency has occurred and whether civil penalties are appropriate. Other commenters discussed the breadth of the NRDC case with respect to SIP provisions. Commenters asserted that the D.C. Circuit did not opine on the authority of the EPA or states to provide relief from noncompliance with technology-based SIP standards that are incorporated into title V operating permits. Commenters also claimed that the D.C. Circuit expressly reserved judgment concerning the validity of such defenses in SIPs, 8 and that states have discretion under the CAA to include affirmative defense provisions in their SIPs. These commenters attempted to distinguish SIPs from the section 112 standards at issue in the NRDC case. Multiple commenters also incorporated in their comment submissions various attachments related to the Startup, Shutdown, and Malfunction (SSM) SIP Action, 9 including comments submitted on the initial and supplemental SSM SIP Call proposals  10 as well as briefs filed in the ongoing SSM SIP Action litigation. 11 Portions of these attachments addressed the EPA's interpretation of the NRDC case.

Response: The EPA disagrees with commenters' assertions that the logic of the NRDC case was restricted to the context of section 112 standards, or to a single NESHAP standard. Most of these comments do not address the fundamental legal principles upon which the D.C. Circuit based its decision, or the EPA's explanation of these principles. Contrary to what some commenters suggest, the NRDC decision was not based on any statutory mandates specific to promulgating CAA section 112 standards. Instead, the decision was based on CAA sections 113 and 304, which apply broadly to the enforcement of a wide range of CAA requirements, including SIP requirements. Thus, any differences between section 112 standards and other standards contained in title V permits (or, for example, the difference between malfunctions and emergencies) are irrelevant to the legal principles upon which the NRDC decision was based, and which apply equally well to the EPA's title V regulations in 40 CFR 70.6(g) and 71.6(g), as discussed in the preceding subsection.

The EPA also disagrees that NRDC is distinguishable from the current action due to any functional differences between the affirmative defense at issue in NRDC, which some commenters characterized as a defense to a claim for civil penalties for violations, and the title V emergency affirmative defense, which commenters characterized as a defense to an action brought for noncompliance. Both the title V affirmative defense and the portland cement NESHAP malfunction affirmative defense (originally located at 40 CFR 63.1344) established an affirmative defense that a source could assert in actions brought under CAA sections 113 and 304, after an enforcement action had been initiated for an alleged violation. 12 Both affirmative defense provisions functioned in the same manner. The fact that the portland cement defense was confined to enforcement actions for penalties, whereas the title V provisions do not on their face contain such an explicit restriction and could potentially be read more broadly, is irrelevant to the fact that both provisions purported to interfere with the authority of courts to determine whether and to what extent relief is appropriate in a given case, including relief from penalties. Moreover, CAA section 304(a), upon which the D.C. Circuit relied, is not restricted to monetary penalties. The EPA has previously explained its position that affirmative defenses are inappropriate regardless of what type of event they apply to, what criteria they contain, or what forms of remedy they purport to limit or eliminate. The EPA also notes that the title V emergency affirmative defense provisions were explicitly restricted to noncompliance with technology-based emission limits (such as emission limits derived from a NESHAP similar to the ones the D.C. Circuit invalidated) and were never available as a defense in an enforcement case for violations of other types of title V permit requirements, contrary to some commenters' assertions.

Finally, the EPA disagrees with commenters' claims that the title V affirmative defense provisions would not impair a court's ability to decide whether civil penalties are appropriate because a source attempting to invoke the title V emergency affirmative defense would have the burden to prove that an emergency occurred and other demonstration requirements had been met. The affirmative defense provision formerly in the portland cement NESHAP was similarly structured, and the D.C. Circuit nonetheless found that those provisions impermissibly intruded into the judiciary's role to determine whether penalties are appropriate. Any comments challenging the holding of the D.C. Circuit in NRDC are beyond the scope of this rulemaking. To the extent that commenters suggested that a title V affirmative defense provision could be appropriate with respect to certain technology-based SIP requirements contained in a title V permit, the EPA disagrees. For the reasons previously discussed, affirmative defense provisions in title V permits are not appropriate with respect to any federally-enforceable requirements. To the extent that commenters discussed the relationship between the NRDC and Sierra Club cases and affirmative defense provisions contained within SIPs, and to the extent that commenters incorporated comments or briefs relevant to the SSM SIP Action but did not specifically explain how those comments were pertinent to the EPA's proposal to eliminate the title V emergency affirmative defense provisions, such comments are beyond the scope of this current rulemaking. Moreover, the EPA has previously responded to those comments and legal briefs in the appropriate venues. 13 To the extent that comments addressed issues relevant to this action, the EPA is responding to these comments in this document.

Comment: Many commenters argued that the NRDC decision only invalidated affirmative defenses that could be asserted in citizen suits brought under CAA section 304 in federal court. These commenters asserted that the NRDC case does not require the EPA to remove affirmative defenses with respect to either: (1) EPA-initiated civil judicial enforcement actions under section 113(b); or (2) administrative penalty actions brought under section 113(d). Many of these commenters recommended that instead of entirely removing the title V emergency affirmative defense provisions, the EPA should amend the provisions to clarify that they do not apply to any enforcement actions based on section 304, but only to actions based on sections 113(b) and (d).

First, regarding EPA-initiated enforcement under section 113(b), some commenters acknowledged the EPA's position (as explained in the 2016 proposed rule) that, because both sections 304 and 113(b) vest federal district courts with the ability to determine liability and assess penalties, the EPA's hands are tied with respect to its own civil enforcement. One commenter noted that the NRDC case did not directly speak to enforcement actions brought by the EPA under section 113(b). Other commenters claimed that section 113(b) does nothing to impede the EPA's ability to define the circumstances under which it is “appropriate” to initiate an enforcement action, and that this would not interfere with the authority of a court to determine liability and assess penalties in an eventual enforcement action. Some commenters suggested that the EPA could use the affirmative defense to define by rule when it would be appropriate to commence an enforcement action, and others noted that the practical effect of the defense is to define when the EPA will exercise its enforcement discretion to initiate an enforcement action in the courts.

Second, regarding the EPA's authority to assess administrative penalties under section 113(d), commenters cited language from the NRDC decision, wherein the D.C. Circuit noted that, although the EPA did not have discretion to determine whether civil penalties should be imposed by a court, the agency had discretion to determine whether to assess administrative penalties under section 113(d). 14 Various commenters similarly alleged that because CAA section 113(d) explicitly gives the EPA the authority to modify penalties, it therefore allows the EPA to establish an affirmative defense in the context of administrative enforcement. Some commenters claimed that retaining the title V affirmative defense for administrative enforcement is especially important because most penalties related to emission exceedances are imposed through administrative penalties sought by the agency, not as a result of citizen suits in federal court. Finally, some commenters suggested that the EPA could define when it would be appropriate to assess administrative penalties.

Commenters also made similar arguments with respect to the ability of states to determine when it would be appropriate to pursue enforcement action, whether through the courts or with respect to administrative penalties.

Response: The EPA disagrees with the claim that it would be appropriate to retain the title V affirmative defense provisions for use in EPA-initiated judicial enforcement or administrative penalty actions. First, as explained previously and as acknowledged by commenters, the logic of the NRDC case applies not only to citizen-suit actions under section 304(a), but also to judicial enforcement actions initiated by DOJ on behalf of the EPA pursuant to section 113(b). Like section 304(a), section 113(b) involves enforcement actions that are ultimately brought before federal courts. Therefore, any affirmative defense that could be asserted in an enforcement proceeding brought under section 113(b) would similarly infringe on the authority of courts to determine appropriate penalties. Regarding suggestions that the EPA could treat the affirmative defense as establishing criteria defining whether the EPA considers it “appropriate” to commence an enforcement action under section 113(b), the EPA finds that this is not necessary or appropriate. For the reasons provided in section III.D.2. of this document, the EPA has decided not to explicitly codify such an “enforcement discretion” type provision.

Second, the EPA acknowledges that NRDC does not address the EPA's authority to establish an affirmative defense to CAA section 113(d) administrative actions. However, such an affirmative defense is not necessary. As discussed further in section III.D.2., if a source believes it is unable to comply with emissions standards as a result of an emergency, the EPA may use its case-by-case enforcement discretion to determine whether to initiate enforcement, as appropriate. Further, as the D.C. Circuit recognized, in an EPA or citizen enforcement action, the court has the discretion to consider any defense raised and determine whether penalties are appropriate. 15 The same is true for EPA administrative actions. Moreover, assessment of penalties for violations in administrative proceedings and judicial proceedings should generally be consistent. Cf. CAA section 113(e), 42 U.S.C. 7413(e) (requiring both the Administrator of the EPA and the court to take specified criteria into account when assessing penalties). The EPA has previously explained this approach in various rules developed under CAA sections 111, 112, and 129. 16

Section IV.A.3. of this document discusses similar issues regarding how states may be able to implement this rule by retaining or developing similar provisions that apply in the limited context of state-initiated administrative enforcement actions or judicial enforcement in state courts.

In the 2016 proposed rule, the EPA noted that the D.C. Circuit in Sierra Club vacated an EPA rule that exempted sources from otherwise applicable emissions standards during periods of SSM because the SSM exemption violated the CAA requirement that such standards apply continuously. The EPA stated that, although the title V emergency affirmative defenses were not exemptions, if they were to be construed or treated as exemptions, they would run afoul of Sierra Club and also should be removed for that reason. The EPA received various comments relating to these issues.

Comment: Commenters presented differing perspectives on how the title V emergency affirmative defense provisions function. The majority of commenters addressing this topic supported the EPA's position that the title V affirmative defense provisions, by their terms, clearly function as an affirmative defense, rather than as exemptions or provisions that define when a violation occurs. Commenters supporting this perspective explained that applicable emission limits would still apply during an emergency, and exceedances would still constitute a violation, but sources could later assert the affirmative defense in an effort to demonstrate to either the agency or a judge that, despite a violation of the applicable requirement, there are valid reasons to excuse the source from some or all penalties associated with the violation. Another commenter noted the very strict conditions that a source attempting to claim the affirmative defense for an emergency would have to comply with and document in order to be eligible for the affirmative defense. Similarly, commenters acknowledged that asserting this defense would not automatically mean it was granted.

However, other commenters suggested that the affirmative defense provisions functionally serve as exemptions to applicable emission limits or define when a violation of an emission limit has occurred. For example, one commenter claimed that the title V affirmative defense provisions operate as an exemption, whereby no restriction or emission limit would exist in specific emergency circumstances. One commenter suggested that the affirmative defenses found in 40 CFR 70.6(g) are an affirmative defense to liability rather than an affirmative defense for the reduction of penalties, which the commenter claims was considered in NRDC. Other commenters claimed that the title V affirmative defense essentially provides criteria for the EPA, the state, or a court to consider when deciding whether excess emissions trigger a violation in the first instance, and these commenters attempted to distinguish the title V affirmative defense from the section 112 affirmative defense at issue in the NRDC decision. Environmental commenters stated that the emergency provisions could be interpreted to mean that, when their terms are met, a source did not violate the relevant emission limitation, thereby effectively providing an exemption. Environmental commenters also argued that this type of functional exemption would be illegal.

Finally, one commenter suggested that the EPA convert the emergency affirmative defense provisions into a narrowly tailored exemption from technology-based standards. The commenter asserted that this approach would be within the EPA's authority, and that an exemption would provide more consistency than the use of enforcement discretion alone.

Response: The EPA agrees with the majority of commenters that acknowledged that the title V emergency affirmative defense provisions did not create exemptions or otherwise define whether a violation has occurred, as stated in the proposal. 17 The provisions being removed through this action, found at 40 CFR 70.6(g)(2) and 71.6(g)(3) state, in part, “An emergency constitutes an affirmative defense to an action brought for noncompliance with . . . technology-based emission limitations.” By their terms, these provisions explicitly purported to establish an affirmative defense to an enforcement action, not an exemption. Moreover, these provisions purported to establish an affirmative defense to an action brought for noncompliance with certain emission limits. So, before the defense would apply, alleged noncompliance with an emissions limitation would have already occurred, and an enforcement action (administrative or judicial) would have been brought because of such noncompliance. The title V affirmative defenses, like the affirmative defense provisions at issue in the NRDC case, were thus based on the establishment of an alleged violation of permitted emission limits in the first instance. Moreover, it would not have been the burden of the party bringing an action for noncompliance to negate any claimed emergency “exemption” to an otherwise applicable emission limit. Rather, it would clearly have been the source's burden in defending against such an action to properly assert and prove all the elements of the emergency affirmative defense. 18 The result of a successfully pled affirmative defense would be to provide the decision maker in an enforcement case with reasons why, despite violations of an emission limit, the source should not be held liable and assessed penalties (or potentially other forms of relief) for such noncompliance. Therefore, the EPA believes that the title V emergency affirmative defense provisions were not intended and should not be interpreted to function as an exemption or to otherwise define when a violation has occurred.

To the extent that the affirmative defense provisions could have been interpreted to provide an exemption or define whether a violation has occurred, the EPA reiterates that such an exemption would be impermissible under the EPA's interpretation of the CAA and in light of Sierra Club. Some commenters suggested that the EPA should interpret the affirmative defense to function as an affirmative defense to liability or to define whether the emission limitation applies and thus whether there is a “violation.” But, if there is no “violation” when certain criteria or conditions for an affirmative defense are met, then there is, in effect, no emission limitation that applies when the criteria or conditions are met, and the affirmative defense would operate to create an exemption from the emission limitation. As discussed in the following subsection, and based on the EPA's interpretation of the Sierra Club decision, this would violate the basic CAA principle that emission limitations must apply continuously and cannot contain exemptions, conditional or otherwise. For the same reasons, it is not appropriate to convert the title V emergency affirmative defense provisions into an exemption, as suggested by a commenter.

Comment: Commenters presented differing views on the EPA's interpretation of Sierra Club. Environmental commenters supported the EPA's conclusion that exemptions from emission limitations are unlawful, and that, to the extent that the title V emergency affirmative defense provisions could be interpreted as providing for an exemption, those provisions would be unlawful. Commenters noted that in the Sierra Club case, the D.C. Circuit held that sections 112 and 302(k), read together, require that there must be continuous section 112-compliant standards. Commenters claimed that the statutory terms “emission standard” and “emission limitation” mean the same thing, citing CAA section 302(k). Therefore, commenters asserted the court's holding in Sierra Club also applies to the emission limitations affected by the title V affirmative defenses. Environmental commenters further asserted that the fundamental principles underlying the Sierra Club decision with respect to exemptions were reinforced by the D.C. Circuit's U.S. Sugar decision.

However, a number of industry commenters challenged the EPA's interpretation of the Sierra Club case, arguing generally that the case has limited applicability beyond the context of section 112 standards. Some commenters asserted that Sierra Club is not relevant to the current rulemaking because the case was anchored to the unique language of CAA section 112 and only addressed exemptions under CAA section 112, rather than regulations in operating permit programs, SIP requirements, or New Source Performance Standards (NSPS) regulations. One commenter argued that because the Sierra Club decision was limited to section 112 standards, the decision could at most be read to prohibit title V provisions excusing noncompliance with an underlying NESHAP provision.

Other commenters asserted that requirements that limit emissions on a continuous basis do not have to impose the same limitation at all times, and that the form of the limitation does not always have to be the same. For example, commenters noted that CAA section 302(k) includes design, equipment, work practice, and operational standards, which could apply during periods of operation not covered by a numerical emissions limitation. These commenters claim that the Sierra Club case did not approach the question of whether these different types of standards would be acceptable. One commenter also asserted that the emergency affirmative defense is not an exemption from continuously applicable emission limits.

Response: As discussed in the preceding subsection, the title V emergency affirmative defense provisions should not be interpreted to provide an exemption to emission limits or otherwise define when a violation of an emission limitation has occurred. However, as noted in the proposal, to the extent that the title V provisions could be interpreted as providing such an exemption, this would run afoul of the CAA requirement that emission limitations be continuous. See CAA section 302(k), 42 U.S.C. 7602(k). The EPA disagrees with commenters' assertions that the Sierra Club court's reasoning does not apply beyond section 112 standards. As the EPA has explained in depth in other documents, the same logic prohibiting exemptions from NESHAP emission limits applies to other emission limitations subject to the definition of “emission limitation” within section 302(k), including emission limits contained within a source's title V permit. 19 Finally, comments on whether it is appropriate to impose different types of emission limitations during different modes of operation may be relevant to standard-setting or other proceedings where such limitations are established, but these comments are not material to this rulemaking to remove the title V emergency affirmative defense provisions.

This section addresses comments involving other legal and policy considerations related to the EPA's removal of the title V emergency affirmative defense provisions.

Comment: Some state and industry commenters urged the EPA to delay finalizing this action until the ongoing SSM SIP Action litigation concludes. These commenters claimed that the EPA's rationale underlying this title V action depends on the same core legal issues involving the EPA's interpretation of the NRDC and Sierra Club cases, which the commenters claimed is currently under judicial review in the SSM SIP Action litigation. One commenter further asserted that an adverse ruling in the SSM SIP Action litigation would be dispositive of the issues involved here.

Response: The EPA disagrees with the commenters' suggestion to delay this final action. The EPA has no reason to delay moving forward with the removal of affirmative defense provisions from various CAA program areas, including title V, solely because litigants have challenged the SSM SIP Action. The EPA is confident of the strong legal and policy bases for this current action, as well as prior actions in the SSM SIP Action and numerous regulations promulgated under CAA sections 111, 112, and 129 that also address affirmative defense provisions. In fact, the EPA's interpretation of the CAA and its application of relevant court decisions was upheld by the D.C. Circuit. 20 The EPA also disagrees with commenters' assertions that an adverse decision with respect to the SSM SIP Action would necessarily undermine the legal justification for this rule, because the SSM SIP Action litigation could be decided on procedural or substantive grounds that would not be determinative for this action. For example, the ongoing SSM SIP Action litigation involves many issues that are unrelated to this current rulemaking. 21

Comment: Multiple state and industry commenters discussed court decisions involving SSM issues and affirmative defenses predating the NRDC cases. These commenters generally asserted that the EPA relied too heavily on the NRDC case in justifying the current action, and that the EPA failed to address the importance of prior case law and the relationship between these prior cases and the NRDC case.

Many of these commenters cited to the Fifth Circuit's Luminant   22 decision, where commenters asserted the court determined that affirmative defense provisions do not interfere with a court's jurisdiction to assess civil penalties or enforce the CAA, contrary to the D.C. Circuit's decision in NRDC. One commenter, acknowledging the differing outcomes of the Luminant and NRDC cases, asked the EPA to discuss this dissonance and claimed that the EPA should have sought en banc review of the NRDC decision before the full D.C. Circuit, or alternatively sought review by the Supreme Court. Another commenter suggested that the EPA should delay finalizing this rule because of the confusion in the courts resulting from the differing NRDC and Luminant decisions. Some commenters claimed that the Luminant case is more directly relevant to the current action than the NRDC case. One commenter asserted that the Luminant case would be controlling over the NRDC case in states within the Fifth Circuit's jurisdiction, including Texas. Some commenters noted that the NRDC case explicitly distinguished its holding from that of Luminant and avoided confronting the SIP issues discussed in Luminant. Similarly, some commenters cited the Eleventh Circuit's Georgia Power   23 case, which also involved affirmative defense provisions contained within a SIP. Some commenters also cited two cases where circuit courts upheld the EPA's ability to use affirmative defense provisions in Federal Implementation Plans (FIPs), including the Ninth Circuit's Montana Sulphur   24 decision and the Tenth Circuit's Arizona Public Service   25 case. Other commenters cited to prior cases decided in the context of Clean Water Act regulations, including Marathon Oil   26 and Essex Chemical, 27 and claimed that these cases support the creation of mechanisms like affirmative defenses to account for the unforeseeable and uncontrollable failure of even the best technology.

Some commenters also addressed the D.C. Circuit's U.S. Sugar decision. One commenter claimed generally that the case did not undercut the EPA's basis for providing the title V emergency affirmative defense. Other commenters, however, claimed that U.S. Sugar reinforced the EPA's view that affirmative defense provisions that constrain or interfere with a court's authority under CAA sections 113 and 304 are inimical to the Act.

Response: The EPA acknowledges that various circuit court cases preceding the D.C. Circuit's NRDC decision, including the Fifth Circuit's Luminant decision, upheld the agency's prior interpretation of affirmative defense provisions in various contexts, including the authority of the EPA to approve affirmative defense provisions contained in SIPs and the authority of the EPA to create affirmative defense provisions in FIPs. In these decisions, the courts deferred to the EPA's prior interpretation of the CAA with respect to affirmative defense provisions. 28 While some courts found the EPA's former interpretation permissible, those courts did not determine that the EPA's former interpretation was the only or even the best permissible interpretation. As previously noted, it is well within the EPA's legal authority to now revise its interpretation to a different interpretation of the CAA. 29 Those prior decisions were based upon an interpretation of the CAA that the agency no longer holds, and therefore those prior decisions do not speak to the validity of the EPA's current policy with respect to affirmative defenses. The EPA further notes that the affirmative defense provisions at issue in the other court decisions cited by the commenters, including affirmative defenses in SIPs and FIPs, are not affected by this action.

In NRDC, however, the D.C. Circuit conclusively determined that the EPA's former interpretation of the CAA concerning affirmative defenses was not permissible with respect to section 112 standards promulgated by the EPA. The NRDC court vacated the affirmative defense provisions in that case, finding them without legal basis because they contradicted fundamental requirements of the Act concerning the authority of courts to decide whether to assess civil penalties in CAA enforcement suits. Because the NRDC decision interprets CAA sections 113 and 304 and addresses the legal basis for affirmative defense provisions, the EPA has reevaluated its interpretation of the CAA with respect to affirmative defense provisions in title V programs as well. Based on this reevaluation and the reasoning of the NRDC decision, the EPA has determined that it is appropriate to remove the emergency affirmative defense provisions in 40 CFR 70.6(g) and 71.6(g), and to require removal of similar affirmative defense provisions from state operating permit programs and individual operating permits, because these provisions are not authorized by the CAA.

Finally, the EPA notes that the D.C. Circuit's U.S. Sugar decision further reinforced the principles underlying the NRDC decision. In U.S. Sugar, the D.C. Circuit, acknowledging that the EPA could not create an exemption or affirmative defense provision, deferred to the EPA's decision to rely on case-by-case enforcement discretion as the mechanism to handle excess emissions during malfunctions. 30 Arguments suggesting that prior cases, including Marathon Oil and Essex Chemical, require the EPA to provide affirmative defenses in such situations are contrary to the U.S. Sugar decision.

Comment: A number of commenters addressed the EPA's historical policies concerning affirmative defenses, 31 including the title V emergency provisions and the policy considerations underlying this type of mechanism to address emissions in unusual situations. Many commenters discussed the EPA's initial decision to create the title V affirmative defense in the 1992 part 70 rule and 1996 part 71 rule. One commenter claimed that the EPA initially included the title V provisions to do what was right, even if the EPA did not concede that it was required. Commenters focused on the initial purpose of the emergency provisions, asserting that the affirmative defense provisions were a very limited, appropriate recognition that even properly designed and maintained technology is not infallible and can fail due to emergencies beyond the control of a source. Other commenters noted the EPA's prior approach that acknowledged that enforcement and the imposition of penalties might not be appropriate in certain situations beyond the control of the source. Commenters asserted that the NRDC decision does not undermine the policy reasons that initially informed the promulgation of affirmative defense provisions, and that these same policy reasons support the title V emergency affirmative defense provisions.

Commenters also claimed that the title V emergency provisions are consistent with decades of EPA policy, citing various rulemakings and guidance documents. Commenters also stated that these types of affirmative defense provisions were recognized by states long before the 1990 CAA Amendments and the title V operating permits program, and that the title V affirmative defense provisions have existed for over 25 years. Commenters also pointed to other EPA actions justifying affirmative defenses, including FIPs for Montana and New Mexico, EPA's briefs prepared for litigation in the Luminant case, and EPA's withdrawal of Texas' SIP Call. Commenters also noted that affirmative defense provisions are still contained in other regulations promulgated by the EPA, including NSPS and NESHAP standards.

Some commenters addressed the EPA's legal authority to change its policy on affirmative defenses. Commenters asserted that agencies are only permitted to change their existing interpretations when they offer a reasoned explanation for the change, citing various Supreme Court cases including Encino Motorcars, LLC v. Navarro   32 and FCC v. Fox Television Stations. 33 These commenters alleged that the EPA's action is arbitrary and capricious because the EPA has failed to provide an adequate justification for the agency's revised policy with respect to the title V affirmative defenses. However, other commenters acknowledged that the EPA may change its interpretation so long as the agency provides a reasoned explanation, and agreed that the justifications provided by the EPA in the 2016 and 2022 proposed rules are sufficient.

Finally, some commenters discussed the perceived inequity or unfairness of the EPA's change in policy and removal of affirmative defense provisions, based in part on the supposition that sources have come to rely on these provisions. Specific comments addressing how the removal of the title V affirmative defense provisions could impact sources are discussed further in section III.D.2. of this document.

Response: The EPA acknowledges the underlying considerations supporting the EPA's past policies—especially the agency's recognition that even well-designed and appropriately operated equipment may sometimes fail due to circumstances beyond the control of the source (such as during emergencies) and that, in certain situations, enforcement for violations of technology-based standards may not be appropriate. This rule does not change that general recognition. As discussed in section III.D.2. of this document, the EPA continues to believe that enforcement may not be warranted under certain specific circumstances, such as during an emergency, as determined on a case-by-case basis by enforcement authorities. The EPA, states, citizens, and the courts retain the discretion and authority to consider such circumstances in evaluating how to respond to exceedances or violations. However, an affirmative defense provision that interferes with the authority of courts to assess penalties is no longer an appropriate or legally sound mechanism to address these situations.

The EPA also acknowledges its past policies regarding different mechanisms to account for excess emissions during periods of SSM and emergencies. Based on these former policies, the EPA previously established affirmative defense provisions in various other CAA program areas, including within previously promulgated FIPs and various NSPS and NESHAP regulations. However, since that time, decisions from the D.C. Circuit, including Sierra Club and NRDC, have established parameters under the CAA regarding legally permissible approaches for addressing excess emissions during periods of SSM or emergency events. In light of these decisions—particularly the 2014 NRDC decision—the EPA has concluded that certain aspects of its prior interpretation of the CAA were not legally permissible under the CAA. Thus, the EPA has revised its interpretation of the CAA with respect to affirmative defense provisions, and this revised interpretation provides the basis for the current action (and similar actions in other CAA program areas).

Following the 2016 proposal, the EPA continued to evaluate SSM provisions, including affirmative defenses, in SIPs. In October 2020, the EPA issued a guidance memorandum that, among other things, expressly superseded a portion of the EPA's interpretation of affirmative defenses presented in the 2015 SSM SIP Policy. 34 However, on September 30, 2021, the EPA issued a guidance memorandum that withdrew the October 2020 memorandum in its entirety and reinstated the legal and policy positions expressed in the 2015 SSM SIP Policy in their entirety. 35 Thus, the EPA's current interpretation of affirmative defenses in the context of SIPs is the interpretation set out in the 2015 SSM SIP Policy.

The EPA's revised interpretation following the NRDC decision was, and continues to be, well within the EPA's legal authority, and the EPA has properly exercised its authority to revise its interpretation of the CAA through the appropriate processes. The authority of an agency to change its interpretation of a statute is well-established, provided that it gives a reasoned explanation for the change. 36 The EPA disagrees with commenters that suggest that the EPA has not provided an adequate rationale for this shift in policy, either generally with respect to affirmative defenses or specifically with respect to the title V emergency affirmative defense provisions. The EPA has clearly articulated its revised interpretation of the CAA with respect to affirmative defenses, here and in other documents, including the 2016 proposed rule (as referenced in the 2022 proposed rule), based on the EPA's analysis of the NRDC decision. 37 Commenters have not substantiated their claim that the EPA's rationale is inadequate.

Comment: A number of commenters acknowledged and addressed the EPA's desire to ensure consistent agency policy with respect to affirmative defense provisions across different CAA program areas. However, some commenters asserted that consistency between the EPA's title V regulations and other CAA programs is not a rationale for taking this action. Other commenters disagreed that the title V provisions should be removed for consistency with actions like the 2015 SSM SIP Action, arguing that the two actions are distinguishable. Finally, some commenters claimed that removal of the title V affirmative defense would actually undermine the goal of consistency across CAA program areas, because title V permits incorporate emission limits developed under numerous CAA regulatory authorities, and because various NSPS, NESHAP, and SIP regulations currently still contain affirmative defense provisions.

One commenter also suggested that the EPA could resolve any inconsistency between the title V affirmative defense provisions and underlying standards that do not allow an affirmative defense by clarifying through an interpretive rule or rule revision that nationwide standards outweigh affirmative defense provisions under title V.

Response: The EPA is not removing the title V emergency affirmative defense provisions solely for the sake of consistency. Rather, as discussed in the proposal and in section III.A. of this document, these provisions present legal issues substantially similar to those that called for the removal of affirmative defense provisions from other regulations. In addition to the legal considerations supporting the current action, and as previously explained in the preamble to the 2016 proposed rule (as referenced in the 2022 proposal), the EPA believes that it is important to apply, as much as reasonably possible, the EPA's policy concerning affirmative defense provisions consistently across CAA program areas. As previously explained, the EPA has removed affirmative defense provisions from numerous other CAA standards since the 2014 NRDC decision. 38 Based on the relationship between title V and these underlying standards, it is particularly important to remove the affirmative defense provisions from the title V program regulations. Title V permits include a wide range of substantive CAA requirements that apply to a source, including SIP provisions and standards developed under CAA sections 111, 112, and 129. Because the title V affirmative defense provisions applied independent of these underlying standards, the title V emergency affirmative defense might be asserted in civil actions or other proceedings involving noncompliance with title V permit terms reflecting standards from which the EPA has recently eliminated affirmative defenses. In this way, the continued presence of the title V affirmative defense provisions could effectively undermine the EPA's efforts to remove affirmative defenses from the underlying standards, as well as the efforts of states to revise SIPs to comply with the 2015 SSM SIP Action. The EPA acknowledges that not all affirmative defense provisions in the EPA's regulations have been removed as of the date of this rule. However, the fact that this is an ongoing process does not provide a basis for retaining or delaying removal of the title V affirmative defense provisions.

Moreover, the EPA does not believe that it would be appropriate to simply clarify in some manner—whether by revising the emergency affirmative defense rules or issuing guidance—that the title V affirmative defense would not apply where the underlying standards do not allow or provide for an affirmative defense. Although this approach could potentially reduce inconsistency between title V provisions and the underlying standards from which affirmative defenses have been removed, it would nonetheless fail to address the more fundamental problem that the title V affirmative defense provisions are, in and of themselves, inconsistent with the enforcement structure of the CAA and thus legally impermissible.

Comment: Commenters raised a number of concerns involving the relationship between the title V emergency affirmative defense and other CAA standards, including section 112 NESHAP, section 111 NSPS, and SIPs. Comments specifically relating to SIPs are discussed in the following subsection.

Commenters claimed generally that the EPA has failed to consider how the CAA requirements related to enforcement must be harmonized with the CAA requirements relating to standard setting and permitting. One commenter claimed that the title V affirmative defense provisions avoid the need to address emergencies in each individual underlying standard, which the commenter characterized as an impractical approach. Another commenter asserted that the title V affirmative defense provisions have effectively become part of the underlying applicable standards, and other commenters suggested that the title V affirmative defense provisions are necessary to ensure that underlying technology-based standards are achievable and adequately demonstrated, taking into account costs. These commenters asserted that removing the affirmative defense would have the effect of making the underlying standards in a permit more stringent than those authorized by the governing standards, in that sources would be subject to a level of control technology that is technologically and economically infeasible. Other commenters suggested that if affirmative defenses are removed, either title V permits or underlying standards would need to provide some other way to account for malfunctions, such as through alternative emission limitations, work practice standards, or malfunction abatement plans.

Some commenters also claimed that the overlap between the title V emergency provisions and various malfunction provisions in NSPS and NESHAP regulations could cause confusion. However, other commenters recognized that the removal of the title V affirmative defense provisions should not have any impact on independent malfunction or emergency provisions contained in underlying technology-based standards.

Lastly, several environmental commenters asserted that EPA must go further and quickly remove “SSM loopholes” from other CAA programs, including section 111 NSPS, section 112 NESHAP, and SIPs.

Response: Many of the comments relating to malfunction emissions and the development of technology-based standards are either not directly related to the current rule to remove the title V emergency affirmative defense provisions or reflect a misunderstanding about the relationship between the title V affirmative defense provisions and underlying standards included within operating permits. As an initial matter, title V of the CAA does not generally impose new substantive requirements on a source. Rather, title V permits provide a vehicle to clarify in a single document the various CAA requirements applicable to a source. Although title V permits must contain conditions (such as monitoring, recordkeeping, and reporting provisions) necessary to assure compliance with all CAA requirements already applicable to a source, title V of the CAA does not provide the basis for making substantive changes to underlying applicable standards. 39 Therefore, title V permits are not an appropriate mechanism for addressing commenters' concerns related to the development of, for example, alternative emission limits, work practice standards, or malfunction abatement plans. These considerations may be more relevant in the context of developing specific SIP provisions or section 111, 112 or 129 standards. 40

Moreover, the underlying standards, not the title V affirmative defense provisions, establish the appropriate level of emission controls, accounting for technological, economic, and other considerations, as appropriate. The title V emergency affirmative defense provisions are not, as some commenters suggested, part of the underlying applicable requirements themselves. The title V affirmative defense provisions operated independently from the specific standards and/or emission limits, as well as any emergency, malfunction, or upset provisions contained within underlying applicable requirements. Although the title V provisions provided for an affirmative defense in emergencies, removal of the affirmative defenses would not make underlying technology-based standards more stringent or otherwise have any effect on standards applicable to a source. The title V provisions merely provided an affirmative defense that a source, after having allegedly violated a technology-based emission limitation contained in its title V permit, could assert in an enforcement proceeding brought for alleged violations of the title V permit term reflecting the requirements of the underlying standard. Because the title V affirmative defense did not provide an exemption to any standard or define when a violation of a standard has occurred, a source's compliance status with the underlying standard itself—as well as the source's compliance status with the title V permit term—would not be affected by the presence or absence of an affirmative defense.

Finally, comments discussing the purported need to provide for or address excess emissions associated with malfunctions are immaterial because this action addresses the title V affirmative defense provisions for emergencies, which—although there may be some similarities—are significantly different, and narrower, than malfunction events. For further discussion, see section III.D.3. of this document.

Comment: Multiple commenters addressed the relationship between this action and the 2015 SSM SIP Action. Some commenters asserted that the EPA's current action is based on the 2015 SSM SIP Action, or claimed that the two actions are related for various reasons. Other commenters claimed that the 2015 SSM SIP Action is not at issue in this rulemaking, disagreed with the EPA's statements that certain aspects of the 2015 SSM SIP Action are especially relevant, and attempted to distinguish the types of provisions at issue in the 2015 SSM SIP Action from those at issue here.

Some commenters also specifically discussed the need for states to develop SIP provisions that account for SSM situations (including work practice standards) and claimed that states should not be prohibited from including approved state SSM plans in title V permits. One commenter suggested that removing the title V affirmative defense provisions before SIP issues are resolved could prevent states from incorporating all applicable requirements, including SIP requirements, into title V permits, and another commenter asserted that this title V rule should be withdrawn while states modify their rules to address the 2015 SSM SIP Action. On the other hand, other commenters suggested that by promptly finalizing this title V rule, the EPA can better facilitate the coordination of SSM SIP revisions with title V program revisions and individual operating permit revisions.

Response: This current title V rule is related to the 2015 SSM SIP Action to the extent that each rule is based at least in part on the EPA's view that, in light of the NRDC decision, affirmative defense provisions are contrary to the enforcement structure of the CAA. 41 However, this title V action is not “based on” the 2015 SSM SIP Action, and the two actions are functionally independent rulemakings, each operating within distinct areas of the CAA's regulatory structure. Therefore, and for the reasons discussed in the preceding subsection discussing the relationship between title V and other CAA standards, this current action involving the title V affirmative defense provisions will not have any effect on states' ability to develop appropriate SIP provisions in response to the 2015 SSM SIP Action, and it will not affect states' ability to ensure that title V permits appropriately reflect all requirements applicable to a source, including revised SIP provisions. In fact, as some commenters indicated, it may be convenient for states to coordinate implementation of any title V permit changes related to the 2015 SSM SIP Action with permit changes related to this rulemaking. Issues regarding implementation of this rule are discussed further in section IV. of this document.

Comment: Some commenters noted that while title V of the CAA does not establish or mandate affirmative defense provisions, neither does title V of the CAA prohibit the EPA from establishing affirmative defenses.

Response: The EPA acknowledges that title V of the CAA is silent with respect to affirmative defense provisions; it neither provides for such provisions nor explicitly prohibits them. However, the EPA interprets other provisions of the CAA that apply to enforcement of the title V operating permits program—including sections 113 and 304—to effectively prohibit the creation of affirmative defense provisions, as discussed in section III.A.1. of this document.

Comment: Some commenters raised constitutional issues with the removal of the title V emergency affirmative defense provisions. Commenters argued that the imposition of penalties for any conduct that is unavoidable violates basic constitutional protections guaranteed by the Eighth Amendment and due process requirements. Commenters further asserted that explicit affirmative defense provisions are necessary to satisfy minimum constitutional standards, and that alternative approaches, such as the exercise of enforcement discretion, are not sufficient.

Response: The EPA disagrees with commenters with respect to these constitutional arguments. The comments suggest that without the title V affirmative defense, any penalty assessed for violation of a title V permit term during an emergency would be per se “excessive” or “arbitrary” and that the existing CAA enforcement provisions would be facially unconstitutional. The EPA disagrees. It should be reiterated, first, that the title V emergency affirmative defense has never been a required permit term and it has not universally been adopted by all permitting authorities for all permits. Even where the defense may be available, it is, by its own terms, very limited and narrowly circumscribed. Commenters have provided no information indicating that the defense has been asserted with any frequency or, indeed, at all. It is difficult to see how the removal from the EPA's regulations of a narrowly circumscribed, discretionary defense that apparently is infrequently asserted could render the CAA unconstitutional.

Moreover, the CAA does not mandate that EPA automatically initiate an enforcement action, let alone automatically assess a penalty, for a violation of a CAA requirement. EPA has absolute discretion on whether to initiate an enforcement action in any circumstance, including during an emergency. 42 If EPA chooses to initiate an enforcement action in a circumstance involving a violation during an emergency, and chooses to seek a penalty for that violation, the CAA establishes a maximum civil penalty in section 113(b)  43 but then expressly provides in section 113(e) that the EPA or the courts “shall take into consideration various criteria—including specifically, “good faith efforts to comply,” and, more generally, “other factors as justice may require.” Thus, the CAA on its face does not mandate the imposition of any penalty automatically, much less one that is per se excessive. The commenters fail to provide any specific support for their claim that the statutory penalty provisions of the CAA are facially unconstitutional, instead making only generalized claims.

In addition, State Farm Mutual Auto Insurance Co. v. Campbell, 44 a case cited by some commenters, provides no support for any claim that removal of the title V affirmative defense would somehow be unconstitutional. State Farm involved a claim that a jury award of $145 million in punitive damages was excessive and, accordingly, contrary to the Due Process Clause of the Fourteenth Amendment to the United States Constitution. Reaffirming that the Fourteenth Amendment “prohibits the imposition of grossly excessive or arbitrary punishments,” the Supreme Court held that, under the particular circumstances of the case, the punitive damages award was excessive and “an irrational and arbitrary deprivation of property.”  45 Here, no penalties have been assessed at all, and State Farm provides no support for the conclusion that—absent the title V emergency affirmative defenses—the CAA's authorization, in accordance with various identified criteria, of possible penalties is necessarily unconstitutional. 46

The EPA also disagrees with the claims that—absent the title V affirmative defenses—the penalty provisions of the CAA would be facially contrary to the Eighth Amendment. Again, if a party believes that the penalties assessed in a particular enforcement action violate the Eighth Amendment, it can raise that claim at the appropriate time. As with the commenters' due process arguments, Congress has addressed the potential for unfair—or unconstitutional—penalties by setting out various criteria to be considered in determining civil penalties. The penalty criteria in section 113(e) provide an opportunity to raise concerns about imposition of penalties in the event of an emergency similar to that afforded by the title V affirmative defenses, albeit directed at the courts' discretion. The commenters do not explain why they believe these explicit statutory factors do not provide sufficient protection against the imposition of an allegedly unconstitutionally excessive penalty.

This section discusses various issues involving the effects of removing the title V emergency affirmative defense provisions, focusing primarily on the impact on sources. Overall, the EPA does not believe that removing the emergency affirmative defense provisions will substantially affect the legal rights of title V sources or the decisions sources make when confronted with emergency situations. It is also important to reiterate that the EPA is basing the current action on its interpretation of the CAA in light of relevant caselaw indicating that these affirmative defense provisions must be removed because they are inconsistent with the enforcement structure of the CAA.

Comment: Multiple state and industry commenters acknowledged the limited scope of the title V affirmative defense provisions, which apply only to emergency situations. Commenters also addressed the relationship between emergencies and malfunctions. While some commenters provided examples of situations that would constitute an emergency but not a malfunction, other commenters asserted that the terms “emergency” and “malfunction” are closely related in that they both relate to unexpected and unforeseen events.

A number of commenters further acknowledged the limited historical and potential use of the title V emergency affirmative defense provisions. However, commenters suggested that the rule could have greater impacts than might be apparent.

Environmental commenters, on the other hand, characterized large SSM exceedances as routine and claimed that large polluters have used affirmative defense provisions in many citizen enforcement actions. Additionally, these commenters asserted that excess emissions are often the result of operator errors, poor plant design, and a lack of preventive maintenance. Thus, commenters claimed that sources using SSM affirmative defense provisions have lacked an incentive to make investments in accident prevention. Finally, these commenters claimed that emissions during SSM and emergency events can be controlled.

Response: The EPA agrees with commenters that emphasized the limited scope of the title V emergency affirmative defense provisions. Unlike more general affirmative defense provisions addressing excess emissions during equipment malfunctions (which some commenters appear to address), the title V provisions being removed were specific to situations that qualify as an “emergency,” defined as “any situation arising from sudden and reasonably unforeseeable events beyond the control of the source, including acts of God, which situation requires immediate corrective action to restore normal operation, and that causes the source to exceed a technology-based emission limitation under the permit, due to unavoidable increases in emissions attributable to the emergency.” 40 CFR 70.6(g)(1). Thus, while the title V emergency affirmative defenses, like affirmative defenses for malfunctions, relate to events that are beyond the control of a source, the title V defenses would only have been available in a more extreme, limited set of circumstances. While it is possible for some overlap in malfunction and emergency situations to exist ( e.g., certain emergency events could potentially cause equipment malfunctions), the EPA believes that the majority of exceedances during malfunction events would not be attributable to “emergencies” as defined in the title V affirmative defense provisions. In addition, the title V affirmative defense provisions being removed contain various procedural requirements that must be met to assert the defense. See 40 CFR 70.6(g)(3). Moreover, as some commenters acknowledged and based on the best information available to the EPA, the title V emergency affirmative defense provisions have rarely, if ever, been asserted in enforcement proceedings. Comments contending that sources frequently or routinely have asserted affirmative defenses appear to relate to SSM affirmative defenses, rather than the narrower title V affirmative defense for emergencies. It is unlikely that the criteria for the title V emergency affirmative defense would have been met in such circumstances, as the title V provisions could not be asserted for (among other things) noncompliance caused by improperly designed equipment, lack of preventative maintenance, careless or improper operation, or operator error.

For these reasons, the EPA does not believe that the removal of the narrowly drawn and apparently infrequently used title V emergency affirmative defense provisions will have a significant impact on sources. Further, as discussed in the following subsection, the EPA, state authorities, and other entities likely would consider the relevant circumstances—especially the relatively unusual, extreme, and unavoidable circumstances that would have qualified under the narrow definition of “emergency”—in deciding whether to pursue enforcement action or seek penalties, and sources remain free to argue to the court, in the event of an enforcement action, that penalties should not be assessed for these same reasons.

Comment: Many commenters expressed concerns that removing the title V emergency affirmative defense provisions would result in less certainty or greater risk of liability to sources confronted with emergency situations. One commenter asserted that even if the EPA is not legally required to provide an affirmative defense in title V permits, the EPA should, to the maximum extent consistent with law, continue to provide and allow states to provide sources relief from the threat of enforcement for exceedances caused by emergencies. Another commenter claimed more generally that the EPA must find other ways to assure sources that they will not be subject to penalties if they operate to provide vital services in an emergency. Commenters generally requested additional guidance from the EPA to provide more certainty to sources in the absence of an explicitly codified affirmative defense.

Most commenters acknowledged the fact that even in the absence of an affirmative defense, the EPA, state, and citizens all retain the discretion to determine whether to bring an enforcement action, based on the unique circumstances of each case. Thus, most commenters acknowledged that not all exceedances of emission limits will automatically result in enforcement actions. One commenter asserted that the EPA routinely uses enforcement discretion to decide which alleged violations to pursue, and that such decisions are often made on the same principles codified in an affirmative defense. Other commenters asserted that the EPA does not intend for true emergencies to result in increased enforcement, and that the EPA's suggested enforcement discretion approach avoids forcing every violation to judicial resolution. Finally, one commenter asserted that the exercise of enforcement discretion by state permitting authorities is appropriate and consistent with CAA sections 113 and 304 and separation of power principles.

However, a number of commenters challenged the sufficiency of relying on enforcement discretion alone to handle excess emissions caused by emergencies. Commenters noted that explicitly codified affirmative defense provisions have the benefit of providing certainty to permittees, promoting consistency to agency actions, and promoting the creation and retention of records necessary to justify agency actions. Commenters claimed that relying on enforcement discretion alone would result in more uncertainty and jeopardy and less harmony among different CAA programs, because enforcement discretion policies may be unwritten and unavailable to the public. Other commenters noted, citing the U.S. Sugar decision, that federal and state policies regarding enforcement discretion do nothing to prevent citizens from pursuing enforcement. Some commenters also asserted that an enforcement discretion approach still leaves sources in the difficult position of choosing between proper emergency response and compliance with emission limits. Other commenters claimed that relying on enforcement discretion puts all power in the hands of the EPA, without any checks and balances, and asserted that this contradicts principles of cooperative federalism and exceeds the authority intended in the passage of the CAA.

Some commenters discussed how prior court decisions have treated enforcement discretion. One commenter claimed that the D.C. Circuit in U.S. Sugar acknowledged, but did not evaluate, the EPA's reliance on enforcement discretion, and the commenter alleged that the court appeared to have doubts that enforcement discretion alone is sufficient. Another commenter claimed that the U.S. Sugar decision did not validate the enforcement discretion approach beyond the context of section 112 standards. Other commenters cited to the 1973 D.C. Circuit opinion in Portland Cement Assn. v. Ruckelshaus   47 in support of their position that reliance on enforcement discretion is not a sufficient response to addressing excess emissions from malfunctions, and another commenter claimed that the 9th Circuit rejected the EPA's use of enforcement discretion in the 1977 Marathon Oil   48 Clean Water Act case.

Some commenters requested that the EPA provide additional guidance to clarify the circumstances under which permitting authorities (including the EPA) should exercise their discretion not to bring enforcement actions. Many commenters encouraged the use of the criteria contained in 40 CFR 70.6(g) in guiding permitting authorities' exercise of enforcement discretion. Some commenters asserted that states should be able to rely on those criteria when exercising their enforcement discretion. Other commenters urged the EPA: to make clear that the EPA would not expect to bring an enforcement action under circumstances meeting those criteria; to make clear that the EPA would continue to use its enforcement discretion in the case of emergency situations; and to create a strong policy statement that the EPA does not support civil penalties in situations meeting those criteria. Commenters, with one quoting a passage from the EPA's brief in the U.S. Sugar case, urged the EPA to more fully articulate certain standards for determining whether the EPA would pursue enforcement in a given situation, including consideration of the good faith efforts of a source to minimize emissions, which types of preventative and corrective actions would be considered, and the nature and extent of the root cause analysis that should be employed by sources to ascertain and rectify excess emissions. Another commenter claimed that it is appropriate for permitting authorities to take into account circumstances involving how a source mitigated damage to people and the environment in responding to an emergency.

Relatedly, one commenter suggested that instead of removing the affirmative defense provisions, the EPA should amend them to provide that the affirmative defense may be allowed, if specified conditions are met, at the discretion of the enforcement entity.

Commenters also acknowledged that even when an enforcement action is commenced, the ultimate decision makers also have the discretion to determine whether and to what extent penalties are appropriate in a given situation. Environmental commenters asserted that both the EPA and the NRDC court recognized that even without an affirmative defense, sources are still free to argue to a court that they should be subject to lesser (or no) civil penalties for any number of reasons, including practical considerations or emergencies. Another commenter noted that the D.C. Circuit in U.S. Sugar confirmed that sources may still argue to a court that penalties should not be assessed in a given situation, and that sources may support these arguments with relevant facts, such as the source's compliance history and good faith efforts to comply with emission limits.

However, while some commenters acknowledged that the absence of an affirmative defense would not automatically result in the imposition of particular remedies, other commenters asserted that without an affirmative defense, sources would lack a legal defense in enforcement actions and would be liable for unforeseeable events outside of their control. One commenter claimed that this would be unjust, and that imposing an unjust system would foster disrespect for the law.

Finally, some commenters requested further guidance on how sources could make similar defenses in enforcement proceedings. Commenters requested that the EPA retain or narrow the definition of “emergency” in its regulations, as this definition could help guide a court's review of circumstances that are unlikely to warrant punishment, and could provide more certainty to sources.

Response: As discussed in detail in the 2016 proposal, 49 the EPA reiterates that the legal rights and obligations of individual sources potentially subject to enforcement proceedings will not be significantly affected by the removal of emergency affirmative defense provisions from their title V permits. The absence of an affirmative defense provision in a source's title V permit does not mean that all exceedances of emission limitations in a title V permit, including those resulting from an emergency, will automatically be subject to enforcement or automatically be subject to imposition of penalties or other remedies.

First, any entity that may bring an action to enforce title V permit provisions has enforcement discretion that they may exercise as they deem appropriate in any given circumstance. For example, if the excess emissions caused by an emergency occurred despite proper operation of the facility, and despite the permittee taking all reasonable steps to minimize such emissions, EPA or other relevant entities may well decide that no enforcement action is warranted in a specific case. In the event that an entity decides to bring an enforcement action, it may, nonetheless, take into account the emergency circumstances in deciding what remedies to seek.

The EPA appreciates that relying on enforcement discretion might afford less certainty to sources than an affirmative defense provision. However, as the EPA has explained, the latter approach is not legally consistent with the enforcement structure of the CAA, which among other things imposes a duty on the source to continually comply with emission limits and standards. Moreover, the EPA believes the exercise of enforcement discretion in lieu of a codified affirmative defense provision is both appropriate and sufficient to carry out the mandates established by Congress in the CAA in a fair and equitable fashion, a position that the D.C. Circuit upheld in its U.S. Sugar decision. 50 The EPA believes that it is unlikely that entities would initiate an enforcement action for emissions exceedances resulting solely from a true emergency situation that would have qualified under the narrow definition and particular requirements of the title V emergency affirmative defense provisions. The EPA also generally agrees with commenters that the conditions contained in the title V emergency provisions, including but not limited to the nature of the emergency event and the source's efforts to take all reasonable steps to minimize emissions during an emergency, would likely be important considerations to take into account when deciding whether to pursue enforcement, among all other relevant factors. Enforcement discretion decisions necessarily involve case-specific considerations, which should not be confined to the specific conditions contained in the title V emergency affirmative defense provisions. 51 Thus, the EPA will not, in the course of this rulemaking, provide explicit criteria that the EPA, states, or other entities should apply in determining whether to commence an enforcement action. Nothing in this action precludes the EPA from issuing such guidance in other appropriate proceedings or formats if the agency should subsequently determine that to be appropriate.

Second, even if an enforcement action is commenced for exceedances caused by an emergency, the absence of an explicitly defined affirmative defense provision does not affect a source's ability to demonstrate to the court (or to the EPA in an administrative enforcement action) that penalties or other kinds of relief are not warranted. Under section 113(e), courts (and the EPA in an administrative enforcement action) must consider various factors when assessing monetary penalties, including the source's compliance history, good faith efforts to comply for the duration of the violation, and “such other factors as justice may require.” Thus, with or without an explicit affirmative defense, a source retains the ability to defend itself in an enforcement action and to oppose the imposition of particular remedies or to seek the reduction or elimination of monetary penalties, based on the specific facts and circumstances of the emergency event. The D.C. Circuit has noted that such justifications would be a “good argument . . . to make to the courts.”  52 Thus, overall, elimination of the title V emergency affirmative defense provisions will not deprive sources of these defenses in potential enforcement actions. Sources retain all of the arguments they previously could have made. Congress vested the courts with the authority to judge how best to weigh the evidence in an enforcement action and to determine appropriate remedies. The EPA may not, through the title V affirmative defenses, restrict a court's ability to do so, and the EPA does not believe that it would be appropriate, in this action, to provide guidance to the courts with respect to what factors a court should or must consider.

For similar reasons, the EPA does not believe it would be appropriate or necessary to retain the definition of “emergency” or any of the other provisions formerly contained in 40 CFR 70.6(g) and 71.6(g) that were associated with the title V affirmative defense. These additional provisions, which were created solely for the purpose of supporting the title V affirmative defense and ensuring that it was narrowly tailored, no longer serve a purpose in the EPA's part 70 and part 71 regulations. For example, the EPA does not believe that retaining a standalone definition of “emergency” without any context or application would be helpful to relevant entities determining whether to initiate enforcement or to the courts or an agency determining the appropriate remedies.

As explained in section III.A., affirmative defense provisions by their nature limit or eliminate the authority of federal courts to determine liability or to impose remedies through considerations that differ from the explicit grants of authority in section 113(b) and section 113(e). Therefore, these provisions are not appropriate under the CAA, no matter what type of event they apply to, what criteria they contain, or what forms of remedy they purport to limit or eliminate. Thus, it would not be appropriate to amend the title V affirmative defense provisions to provide that the affirmative defense may be allowed if specified conditions are met, at the discretion of the enforcement entity.

Comment: Industry commenters raised concerns involving how the removal of the title V affirmative defense provisions will affect how sources plan for and react to emergency situations. Many of these comments asserted that without an affirmative defense provision in their title V permits, sources confronted with an emergency situation would be forced to decide whether to (1) comply with operating permit requirements or (2) deal with the emergency situation in a manner protective of human safety or other public interests, at the risk of being held liable for violating permit terms. Specifically, some commenters asserted that facilities faced with the threat of liability may be less willing to shut down systems in an emergency, creating the risk of more catastrophic accidents. Other commenters suggested that sources might shut down earlier than would normally be the case, which could result in resource shortages that could impede emergency response efforts or area recovery. Commenters asserted that the affirmative defense provisions serve the important purpose of allowing sources the flexibility to continue or resume operations to provide vital services in times of emergency.

One industry commenter, citing discussion in the EPA's 2014 SSM SIP Action Supplemental Proposal, asserted that removing the affirmative defense provisions could result in an additional resource burden for sources, who could be forced to invest in facility improvements in order to protect the source from emergency situations.

Other commenters asserted similar arguments specifically concerning electric grid reliability, asserting that sources would have to weigh compliance obligations against the need to continue generating electricity to avert grid reliability problems. Some commenters generally claimed, without describing specific instances, that the title V emergency affirmative defense provisions, in addition to other available mechanisms for relief from penalties, have helped ensure reliable electric grid operation in emergency situations. Several commenters provided specific examples of these situations.

Commenters presented differing views of whether the definition of “emergency” in the title V affirmative defense provisions would encompass reliability or electric system emergencies. One commenter asserted that the definition of “emergency” should cover an extreme situation involving critical reliability concerns because the EPA has recognized that CAA rules need to account for the unique interconnected and interdependent operations of power plants. However, another commenter acknowledged that the definition may not be broad enough to cover this situation, but suggested that the EPA recognize that enforcement may be unwarranted not only for unit-specific emergencies, but also for situations where facilities are called upon to support reliability in the context of a larger electric system emergency.

Some commenters claimed that certain electric system operators cannot force a source to continue generating electricity in order to ensure system reliability if doing so would cause the source to violate an environmental requirement, such as a permit condition. Thus, these commenters expressed concern that without the title V affirmative defense—characterized by the commenters as an “exemption”—electric system operators would not be able to force a source to generate electricity in order to ensure system reliability. Other commenters discussed emergency generation orders issued by the Department of Energy (DOE) under section 202(c) of the Federal Power Act (FPA), 16 U.S.C. 824a(c), by which the DOE may require power plant owners to operate and generate electricity in certain emergency situations. While some commenters expressed concern that a source could face the risk of significant penalties for emissions exceedances resulting from complying with such an order, other commenters discussed an amendment to the FPA that excuses sources from compliance with environmental regulations when necessary to comply with DOE emergency orders. One commenter concluded that this FPA provision should be viewed as complementary to, rather than a substitute for, the title V emergency defense, and another asserted that this legislation indicates congressional support for an emergency defense when electric system reliability is at issue.

Commenters urged the EPA to consult with other agencies with expertise in reliability. Commenters also suggested that the EPA direct federal and state enforcement offices to engage in close consultation with relevant grid operators or reliability authorities prior to initiating enforcement actions where exceedances were caused by a demonstrated reliability need. Commenters also proposed that system operators should be able to submit a reliability analysis in the record of any enforcement proceeding and suggested that courts should not independently assess previously established reliability-related determinations.

Response: The EPA does not believe that the removal of the title V emergency affirmative defense provisions will significantly affect the decision making of sources confronted with emergency situations. Sources confronted with an emergency situation will always have to assess the risk of liability involved with courses of action that would result in exceedances of emission limits contained in title V permits as well as the underlying standards. The EPA does not believe that removing the title V affirmative defense provisions will affect this risk assessment. First, the title V emergency provisions did not provide guaranteed protection from liability. They simply created an affirmative defense that a source, having allegedly violated a technology-based emissions limit, could assert in narrowly defined circumstances after an enforcement action was initiated. Moreover, permittees seeking to assert the defense bore the burden of establishing that a number of required conditions were met.

Second, the incentives that exist for sources to behave in a prudent manner during emergencies remain largely unchanged, even without an explicit affirmative defense. As discussed in section III.D.2. of this document, sources can still argue all available defenses to an alleged violation and/or assert that penalties should not be imposed, based on the particular circumstances. The ability to assert relevant considerations in this manner is not limited to the particular conditions associated with the title V emergency affirmative defense provisions. The EPA agrees that the need to avert catastrophic accidents, or to avert an electric reliability crisis, or any number of other public interest-related considerations, could be especially relevant to the decision whether to pursue enforcement or impose penalties. The EPA cannot, however, restrict or define—through the operation of an affirmative defense or otherwise—the evidence or considerations that a court may take into account when determining whether penalties should be assessed in a given situation.

Additionally, the EPA does not believe that removing the title V emergency affirmative defense provisions will have a significant effect on how sources plan for emergencies or invest in facility improvements in order to prepare for emergencies. The EPA notes that the comments received on this point, and the EPA's statements in the 2014 SSM Supplemental Proposal cited by commenters, are more relevant to preparing for excess emissions from equipment malfunctions than to preparing for emergencies. Moreover, as discussed previously, removing the affirmative defense provisions should not change the incentives that sources have to prepare for emergencies. Prudent behavior with respect to planning for emergency situations and minimizing emissions during an emergency to the maximum extent possible would be just as advantageous to a source seeking to reduce the possibility that enforcement will be initiated (or seeking to establish that penalties are not appropriate) as it would be to a source attempting to meet the criteria of a codified affirmative defense provision. The EPA believes that such prudent behavior is a matter of good business practice that most, if not all, sources would normally pursue irrespective of an affirmative defense. 53

Regarding specific comments concerning electric grid reliability, the EPA does not believe that the current action will have a measurable impact on electric grid reliability, and the EPA does not believe that it is necessary to consult with other agencies with expertise in reliability with respect to the limited actions being taken in this rule. As an initial matter, even if the EPA were to retain the existing title V emergency affirmative defense, the availability of that defense in different types of situations involving issues of grid reliability is uncertain. The EPA generally agrees with the commenters suggesting that most electric grid reliability situations would not have qualified as emergencies eligible for the title V affirmative defense, based on the narrow definition of “emergency” in the title V regulations being removed through this action. 54 However, again, nothing would prevent the consideration of reliability-related circumstances in determining whether to initiate enforcement or in deciding whether penalties are appropriate.

Additionally, contrary to the assertion of commenters, the removal of the affirmative defense provisions should not affect the ability of electric grid operators to request that sources generate electricity in order to avert grid reliability problems. Some of these comments were based on the mistaken premise that the title V affirmative defense provisions functioned as an exemption to emission limits. 55 Moreover, as other commenters note, Congress has provided various forms of relief in these situations, including the amendment to FPA section 202(c) (exempting sources from compliance with environmental regulations when necessary to comply with a DOE emergency order), as well as provisions such as CAA section 110(f) (authorizing state governors to temporarily suspend certain requirements where the President determines a national or regional energy emergency exists). The EPA cannot here provide any further guarantees in this regard in the form of an affirmative defense, exemption, or other mechanism that would run contrary to the CAA.

Comment: Some commenters discussed perceived benefits of retaining affirmative defense provisions as written, in addition to the increased certainty and consistency that commenters believe the provisions provided. One commenter claimed that the various demonstration and reporting requirements in the title V emergency affirmative defense provisions serve as incentives for sources to prevent and minimize excess emissions during emergencies, an incentive that the commenter claimed would be lost if the affirmative defense was removed.

Response: The components of the title V emergency affirmative defense involving recordkeeping and reporting requirements and the obligation for a source to properly operate its facility and take all reasonable steps to minimize excess emissions (40 CFR 70.6(g)(3) and 71.6(g)(3)) were important to limit the scope of the defense and any potential for abuse. However, the EPA does not agree that removing the affirmative defense will eliminate the incentives for sources to appropriately prepare for and respond to emergency situations, to minimize excess emissions, to maintain proper records of such events, or to notify relevant authorities in a timely manner. Because the CAA requires continuous compliance with applicable emission limitations and emission standards, sources should properly operate and take steps to minimize excess emissions at all times. Sources still have an incentive to do all of these things in the event of an emergency, because doing so would continue to be in their best interests both for compliance purposes and for purposes of defending against an enforcement action. Again, the EPA believes that such prudent behavior is a matter of good business practice that most, if not all, sources would normally pursue irrespective of an affirmative defense.

Comment: A number of commenters discussed the potential air quality and public health impacts of removing the title V affirmative defense provision. Industry commenters asserted that removing the affirmative defense provisions would not reduce emissions or provide any air quality benefits. Moreover, industry and state commenters claimed that the EPA has not made any demonstration that emissions during emergencies endanger public health or safety or have resulted in problems with attainment of the NAAQS. One commenter claimed that EPA action to remove the title V affirmative defense provisions would be arbitrary and capricious because the action would impose regulatory burdens without any significant benefit, and because the EPA failed to consider the costs and benefits of its proposed action.

On the other hand, environmental commenters claimed that affirmative defense provisions impermissibly allow large facilities to emit massive amounts of pollution in violation of applicable emission limits without consequence. These commenters provided extensive discussion of the health impacts of different pollutants and cited to numerical data and case studies involving the emissions of a number of large industrial facilities. The commenters asserted that this is an environmental justice issue, as these emissions impact surrounding communities, which the commenters claimed are often low-income communities or communities of color. Environmental commenters asserted that the impacts of climate change may increase the incidence of malfunctions due to extreme weather events.

Response: As previously explained, the EPA is removing the affirmative defense provisions from the title V program regulations because these provisions are inconsistent with the EPA's interpretation of the enforcement structure of the CAA. The EPA is not basing this current action on potential air quality benefits, or a weighing of costs and benefits, associated with the removal of these provisions. While the EPA acknowledges that there are benefits to reducing emissions, including reducing impacts to communities with environmental justice concerns, as previously explained, the purpose of this rulemaking is to eliminate the affirmative defense provisions that EPA finds to be inconsistent with the enforcement structure of the Clean Air Act. This action also does not take into account the impact of climate change on the incidence of malfunctions and, as previously explained, emergencies, which—although there may be some similarities—are significantly different, and narrower, than malfunction events.

Comment: Several industry commenters requested that EPA should consider removing hospital, medical, and infectious waste incinerators (HMIWI) as a title V source category or consider reducing program requirements applicable to HMIWIs. Separately, one commenter expressed disagreement with the EPA's return to its 2015 SSM SIP Policy.

Response: These comments are not relevant to the current rulemaking action and are outside the scope of this final rule.

This section provides guidance and addresses comments on various aspects related to implementing this final rule. First, as indicated in the 2016 and 2022 proposed rules, as a result of the EPA's removal of 40 CFR 70.6(g), state, local and tribal permitting authorities  56 whose part 70 programs contain impermissible affirmative defense provisions  57 must submit program revisions to the EPA to remove such impermissible provisions from their EPA-approved part 70 programs. The part 70 program revision process should follow the procedures in 40 CFR 70.4(a) and (i), as specified in the guidance provided in the following subsections. In summary, the EPA expects that states with part 70 programs containing impermissible affirmative defense provisions will submit to the EPA either a program revision, or a request for an extension of time, within 12 months of the effective date of this final rule— i.e., by August 21, 2024. Other considerations associated with program revisions are discussed further in section IV.A. of this document.

States must also remove title V-based affirmative defense provisions contained in individual operating permits. The EPA encourages states to remove these provisions at their earliest convenience. The EPA expects that any necessary permit changes should occur in the ordinary course of business as states process periodic permit renewals or other unrelated permit modifications. At the latest, states must remove affirmative defense provisions from individual permits during the next permit revision or periodic permit renewal for the source that occurs following either (1) the effective date of this rule (for permit terms based on 40 CFR 70.6(g) or 71.6(g)) or (2) the EPA's approval of state program revisions (for permit terms based on an affirmative defense provision in an EPA-approved title V program). Additional considerations associated with permit revisions are discussed further in section IV.B. of this document.

This section clarifies the EPA's expectations for how the final action to remove 40 CFR 70.6(g) will affect state programs and responds to comments involving these considerations. Specifically, this section describes the actions that some states will need to take in order to submit program revisions to remove impermissible affirmative defense provisions.

As indicated in the 2016 and 2022 proposed rules, as a result of the removal of 40 CFR 70.6(g), the EPA has determined that it is necessary for states whose part 70 programs contain impermissible affirmative defense provisions to submit program revisions to the EPA to remove such provisions from their EPA-approved part 70 programs. 58 This determination is based on the EPA's interpretation of the enforcement structure of the CAA, as informed by the NRDC decision. The EPA's rationale concerning affirmative defenses, presented in section III.A. of this document, applies equally to affirmative defense provisions within state part 70 operating permit programs, which the EPA now considers to be impermissible. The term “impermissible affirmative defense provisions” as used throughout this section is intended to refer to all affirmative defense provisions that, for the same reasons necessitating the EPA's removal of CFR 70.6(g) and 71.6(g), are inconsistent with the CAA. This includes, but is not limited to, any provisions within EPA-approved part 70 programs that are similar to, based on, or function in similar ways to the provisions being removed from 40 CFR 70.6(g). For example, any title V provisions that establish an affirmative defense that could be asserted in a civil enforcement action involving alleged noncompliance with any federally-enforceable standards would be inconsistent with the enforcement structure of the CAA. Such provisions are impermissible regardless of whether the affirmative defense provisions are specific to emergency situations, and regardless of other criteria contained within such provisions. Any provisions in an EPA-approved part 70 program that establish an exemption to emission limitations as described in this document will similarly need to be removed. This action will not have any direct effect on affirmative defense provisions established under other CAA programs, such as the SIP or section 111, 112, or 129 programs.

Comment: Multiple commenters objected to the EPA's indication that, if the EPA finalized the removal of 70.6(g), it may be necessary for states with similar affirmative defense provisions to remove those provisions and submit program revisions.

A number of commenters discussed the legal authority by which the EPA could require state program revisions. Environmental commenters suggested that CAA section 502(b), read together with sections 502(d) and (i) and with 40 CFR 70.4, plainly authorizes the EPA to revise the minimum elements of operating permit program regulations when the Administrator determines that revisions are necessary to meet the requirements of the CAA. Other commenters argued that the EPA has no legal basis for imposing its policy preference on states, and some industry commenters claimed that nothing in the CAA authorizes the EPA to withdraw its final approval of a state title V permit program because the EPA prefers a particular improvement to what was already approved, claiming that this would be contrary to Congressional intent and the purpose of title V. One state commenter similarly claimed that requiring program revisions would fundamentally shift the careful balance between the state and the federal governments' regulatory partnership. Some commenters also claimed that requiring states to make title V program changes would constitute a challenge to the legality of state programs and would require a finding that there is no situation where the state program provisions can be applied in a way that is consistent with the Act. One commenter characterized state program revisions as an unfunded mandate, which the commenter asserted should not be imposed on states without a clear and compelling need. One commenter claimed that the EPA has impermissibly extended its interpretation of the NRDC case to state operating permit programs.

State commenters discussed the authority of states to tailor the details of their own title V program regulations and potential limits on the EPA's authority to dictate the fine particulars of state programs. One state commenter claimed that by removing the title V emergency affirmative defense provisions, the EPA would substantially raise the minimum elements required by the Act for state operating permit programs, citing 40 CFR 70.1(a). Other state commenters claimed that under title V, similar to CAA section 110 for SIPs, after the EPA sets minimum program requirements, states must meet these minimum requirements but have the authority and discretion to otherwise tailor their program to their specific state requirements, such as by providing for affirmative defenses. State commenters further asserted that the EPA's implementing regulations do not require a state's enforcement program to be set out in any particular manner, while acknowledging that states must have adequate authority to carry out all aspects of the program and submit a description of their enforcement program to the EPA, citing 40 CFR 70.4(b)(3) and (5). One state commenter noted that an acceptable enforcement program should include the ability to account for emissions during distinct periods of operation, including SSM.

Both state and industry commenters also highlighted the fact that the title V emergency provisions have always been discretionary, not required, elements of state programs. One commenter argued that because the affirmative defense provisions were initially discretionary, it should now be up to states to decide whether to retain them. The commenter claimed that this is a logical extension of a state's constitutional authority and that the EPA should not disturb state authorities by disapproving existing state permit programs that contain these provisions.

Response: The EPA agrees with those commenters who asserted that the CAA authorizes the EPA to revise its part 70 implementing regulations when necessary to conform to the CAA, including provisions of the CAA that apply to the enforcement of title V permit requirements. As the CAA and the EPA's implementing regulations are periodically updated to address evolving legal, policy, technical, and scientific information, so must state operating programs be updated. State part 70 program revisions, while infrequent, are a natural and necessary part of a complex regulatory program, and this process is entirely consistent with the principles of cooperative federalism established in title V of the CAA. As various commenters acknowledged, the EPA has the authority to establish the minimum elements for state title V programs. See CAA section 502. The EPA's part 70 regulations implement this authority. When the EPA must remove an element from its implementing regulations in order to maintain consistency with CAA requirements, it follows that it would also generally be necessary to revise EPA-approved state part 70 programs to meet the same minimum legal requirements required by the CAA. The EPA acknowledges that states may establish additional permitting requirements, but only to the extent they are not inconsistent with the CAA. See CAA section 506(a). States do not have discretion to implement provisions that are inconsistent with the enforcement structure of the CAA or the EPA's part 70 regulations.

As some commenters acknowledged, the EPA's existing part 70 implementing regulations clearly establish a framework by which state part 70 programs may need to occasionally be revised, including when the part 70 regulations are revised or modified. See, e.g., 40 CFR 70.4(a) (if part 70 is revised and the Administrator determines that changes to approved state programs are necessary, states must submit program revisions); 70.4(i) (program revisions may be necessary when relevant federal or state statutes or regulations are modified). The EPA has the authority to approve or disapprove program revisions based on the requirements of the part 70 regulations and the CAA. See 40 CFR 70.4(i)(1), (2). Thus, the EPA has authority to require state title V program revisions.

To be clear, the final action being taken in this rule is the removal of the affirmative defense provisions from the EPA's regulations at 40 CFR 70.6(g) and 71.6(g). As a consequence of this regulatory action, it will be necessary for states with part 70 programs containing impermissible affirmative defense provisions to make conforming revisions to their part 70 programs. However, contrary to the assertions of some commenters, the EPA is not, at this time, disapproving or making any finding of deficiency or inadequacy with respect to any particular state program (such as a finding under 40 CFR 70.10), although this type of determination may be appropriate at a later time. This document clarifies the EPA's expectations for how the program revision process will unfold, based on the EPA's existing implementing regulations and the EPA's longstanding experience in overseeing title V operating permit programs. The EPA intends that this guidance will be useful to permitting authorities and permit holders interested in understanding how removal of the affirmative defense provisions from the EPA's regulations will affect their programs and individual permits, respectively.

The EPA also reiterates, as multiple commenters acknowledged, that the title V affirmative defense provisions have always been discretionary elements of state permitting programs, and the EPA has never required states to adopt these provisions. In fact, a number of state part 70 programs do not appear to contain any such title V affirmative defense provisions. However, contrary to one commenter's assertion, the fact that these provisions were never required elements of state programs does not mean that they now must be deemed appropriate program elements or that states must be allowed to continue implementing them.

Finally, as explained in section V.D. below, this action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no new enforceable duty on any state, local or tribal governments or the private sector. As a result of this rule, some states with EPA-approved part 70 programs that contain impermissible affirmative defense provisions will be required to submit program revisions to the EPA, according to the framework established by the EPA's existing regulations. To the extent that such affected states allow local air districts or planning organizations to implement portions of the state's obligation under the CAA, the regulatory requirements of this action do not significantly or uniquely affect small governments because those governments have already undertaken the obligation to comply with the CAA.

Comment: Commenters addressed various aspects of the scope of state program revisions that would be necessary following the removal of 40 CFR 70.6(g). First, some commenters claimed that part 70 program regulations that incorporate by reference 40 CFR 70.6(g) or any state affirmative defense provisions effectively function the same as regulations that expressly include an affirmative defense. Commenters claimed that if these provisions were not removed from state programs, they would create ambiguity and would undermine CAA enforcement. Therefore, these commenters asserted that part 70 program regulations that incorporate by reference any other affirmative defense provisions must also be removed from state programs.

Next, multiple commenters expressed support for the view that states may retain affirmative defense provisions that could be used for alleged noncompliance with permit requirements arising solely from state law. Some commenters asserted that the EPA has no authority to limit the ability of states to provide this type of state-only affirmative defense provision. Another commenter suggested that state-only affirmative defense provisions should be available not only for enforcement actions brought by state agencies, but also for enforcement actions brought by citizens or the EPA. However, other commenters indicated concern that sources could attempt to invoke state-only affirmative defense provisions in enforcement proceedings involving noncompliance with federal requirements, thereby undermining the enforcement of the CAA. These commenters suggested that the EPA provide guidance to clarify that if a state wishes to retain an affirmative defense for noncompliance with state-only requirements, the state must also include clarifying language in their regulations expressly limiting the applicability of such remaining affirmative defense provisions. Commenters also suggested that states identify these state-only program provisions in their title V program revisions.

Additionally, some commenters asserted that states should be able to circumscribe their own authority to enforce even federally enforceable requirements. Commenters suggested that states should be able to provide an affirmative defense to state-initiated enforcement (such as for administrative penalty proceedings) or otherwise restrict their ability to enforce alleged violations of federally-enforceable applicable requirements.

Finally, some commenters disagreed with the EPA's suggestion that states may retain portions of the emergency provisions, such as the definition of “emergency” or certain reporting requirements, for purposes of supporting other regulations that do not involve an affirmative defense. The commenters expressed concern that the presence of a definition of “emergency” or other recordkeeping, reporting, or work practice requirements could be interpreted as providing for an affirmative defense or otherwise excusing a source from compliance during these periods. However, these commenters also asserted that the EPA should encourage more readily accessible information about excess emission events, in order to better inform surrounding communities of air quality issues.

Response: As previously noted, all impermissible affirmative defense provisions, as specified in section IV.A.1. of this document, will need to be removed from EPA-approved part 70 programs. To reiterate, this encompasses provisions that are similar to, based on, or function in similar ways to the provisions in 40 CFR 70.6(g) that the EPA is removing in this action, including all provisions that effectively establish an affirmative defense that could be asserted in an enforcement action involving alleged noncompliance with any federally-enforceable standards. In light of comments received, the EPA is also providing clarification on various other topics related to the scope of necessary program revisions.

Regarding state part 70 provisions that incorporate other affirmative defense provisions by reference, as a general matter, the EPA agrees with commenters' assertions that incorporating a provision by reference may have the same legal effect as explicitly including the provision within a regulation. Thus, where a state part 70 program incorporates by reference another independently applicable affirmative defense that suffers the same infirmities as those provisions being removed from 40 CFR 70.6(g) and 71.6(g), the state provision incorporating the affirmative defense provision would generally need to be removed. 59

Concerning the comments supporting the option for states to retain an affirmative defense as a “state-only” provision—which would apply solely to rights and responsibilities created by state law and would not apply to, interfere with, or otherwise affect any requirements or remedies under the CAA or federally-enforceable regulations—the EPA agrees that states have the discretion to develop such state-only provisions, as allowed under state law. However, any such provisions would only be available in enforcement actions brought solely under state law, and they would not be available in enforcement actions brought for alleged violations of any federally-enforceable requirements in a source's title V permit. This rulemaking would have no effect on, and does not preclude states from retaining or creating, such regulations unrelated to the state's EPA-approved part 70 program. State-only affirmative defense provisions that are included within individual operating permits would need to be clearly labeled to indicate their limited applicability. 40 CFR 70.6(b)(2).

However, notwithstanding the ability of states to create state-only affirmative defense provisions within their state regulations, any impermissible affirmative defense provisions contained within any EPA-approved part 70 programs will nonetheless need to be removed from the state's EPA-approved part 70 program. In such instances, the state would need to transmit to the EPA a program revision submittal to remove the affirmative defense provision from the body of regulations that comprise the state's official EPA-approved part 70 program. The EPA believes that the best practice for states would be to conduct a rulemaking to remove the affirmative defense provision from the state's current regulations (or to revise the state regulations to clarify the limited applicability of a state-only affirmative defense) and/or a legislative process to remove such provisions from a state statute, in addition to submitting the part 70 program revision to the EPA to formally remove the provision from the state's EPA-approved part 70 program. This would provide clarity for sources and the public and avoid any inconsistency between the state's EPA-approved part 70 program and the state's current regulations and/or statutes.

Regarding comments suggesting that states should be able to limit their own authority to enforce even federally enforceable requirements, as noted in section III.D.2. of this document, permitting authorities always retain the discretion to determine whether to initiate an enforcement action based on the circumstances of a given case. To the extent that a state develops an “enforcement discretion”-type provision that applied only in its own administrative enforcement actions or only with respect to enforcement actions brought by the state in state courts, such a provision may be appropriate under state rules. 60 However, among the minimum required elements of a title V permit program is the requirement that, consistent with EPA regulations, the permitting authority have adequate authority to assure compliance with applicable standards, requirements, and regulations, and to enforce permits, including the ability to recover civil penalties for each violation. See CAA section 502(b)(5), 42 U.S.C. 7661a(b)(5). EPA regulations further provide that approved title V programs must have appropriate enforcement authority, including the authority to seek injunctive relief and to assess or recover civil penalties for violations of any applicable requirement or permit condition. See 40 CFR 70.11. Thus, to the extent that states wish to describe certain aspects of their enforcement discretion policy within their part 70 program regulations, this could only be permissible provided that the provision does not effectively undermine or eliminate the state's ability to enforce its title V program, even under the circumstances previously covered by the affirmative defense. For example, it would likely not be permissible for a state to establish criteria that, when met, would effectively preclude the state from enforcing, even in part, a federally-enforceable standard. Nor would it be permissible for any such provision to limit the ability of the EPA or citizens to enforce any federally-enforceable permit terms or to interfere with the authority of the federal courts to determine whether and to what extent certain remedies are appropriate in a given case.

Finally, although states may not retain title V provisions establishing an affirmative defense to noncompliance with federal requirements, the EPA reiterates its position that states may choose to retain certain aspects of their existing program regulations—such as the definition of “emergency” and associated reporting and recordkeeping requirements—to support functions unrelated to an affirmative defense, such as prompt reporting requirements. The EPA disagrees with commenters' assertions that the presence of definitions or reporting and recordkeeping requirements associated with emergencies would necessarily imply that an affirmative defense exists or that exceedances of emission limits during emergencies are excused. To the contrary, and although the EPA is not retaining such provisions within its own regulations, states may decide that some of these provisions could potentially serve a useful function for state permitting authorities considering whether to pursue enforcement, for sources faced with the possibility of a state enforcement action, and for the public.

Comment: Multiple state and industry commenters requested that the EPA allow states additional time to submit any required part 70 program revisions. These commenters all asserted that 12 months is not sufficient time to conduct the administrative processes required to change part 70 program regulations, and suggested that anywhere between 18 and 36 months should be allowed, for various reasons. Some state commenters provided specific examples of the administrative actions associated with rulemakings that would necessitate additional time, including outreach, public hearings and comment periods, rule development, gubernatorial approval, legislative committee review, and legislative approval. One state commenter noted that many states face program and staff resource constraints based on other rulemaking obligations. Another state commenter predicted that necessary rule changes may take longer to promulgate because they will be controversial. Some commenters recommended providing additional time for state program revisions because these affirmative defense provisions are not currently causing any pressing problems with enforcement and there is no urgent need to change the provisions. Finally, one commenter suggested that additional time for state program revisions would be necessary to allow time for sources to implement measures to address the loss of the affirmative defense.

Other commenters, on the other hand, recommended a more limited time frame, while acknowledging the discretion that the EPA has under 40 CFR 70.4(a) to extend program revision deadlines. These commenters supported the EPA's default 12-month submission deadline with the possibility of an extended deadline of up to 24 months, on the grounds that states should be able to easily amend their operating permit rules within months, and that prompt action would facilitate the coordination of SIP revisions and title V revisions (and associated permit revisions). Environmental commenters urged the EPA to require states seeking an extension to specifically request additional time and to demonstrate good cause for the extension, and urged that such requests be granted only under compelling circumstances. These commenters also suggested additional details concerning the required form, content, and timing of such an extension request.

Response: As discussed in the proposal, the necessary changes to part 70 programs arising from this rule should generally be relatively minor and straightforward, involving the removal of affirmative defense provisions from the state's part 70 program. 61 Because of the nature of the required revisions, the EPA continues to believe that most or many states should be able to complete the necessary program revisions within 12 months. However, the EPA again appreciates that some states may require more time to complete program revisions, based on a number of different factors associated with their administrative process, including the potential need for legislative approval. Therefore, the EPA is allowing states to submit a request to the appropriate EPA Regional office requesting an extension to this 12-month deadline and demonstrating why such an extension is necessary. Such extension requests should include detailed information concerning the steps that the state will take to revise its part 70 program, as well as the specific timing associated with each of these steps. The EPA understands that many states have lengthy rulemaking processes and expects that requests for extension that include the information identified here in sufficient detail would generally be approved. Nonetheless, the EPA will consider each program revision submission and extension request on a case-by-case basis. The EPA expects that each state with a part 70 program containing impermissible affirmative defense provisions will submit a program revision or request for an extension of time to the EPA by August 21, 2024.

Comment: Two state commenters discussed the details of any required program revision submittals. One state suggested requiring the following four components: (1) legal authorization to revise the state rules and part 70 program; (2) redlined changes to state rules; (3) timeline for planned removal of affirmative defense from each permit; and (4) a plan to make these changes to individual permits. Another state commenter requested additional clarity on what form of legal authority demonstration would be required for program revision submittals, and suggested that a rulemaking certification (certifying that the rules have been reviewed by legal counsel and have been found to be within the legal authority of the agency) would be sufficient and less burdensome than a formal opinion by the state Attorney General. One state commenter further expressed concern with the additional burden that would be associated with preparing and submitting a revised program plan. Finally, one commenter requested clarification of the EPA's intention to publish proposed program revisions in the Federal Register and provide a 30-day public comment period. They requested further clarification on whether the EPA intended to publish notice of approval in the Federal Register or issue a letter to state governors or their designees.

Response: As stated in the introduction to this section regarding program revisions, the part 70 program revision process should follow the procedures in 40 CFR 70.4(a) and (i). The EPA's part 70 regulations provide that for state program revisions, the state should submit such documents as the EPA determines to be necessary. See 40 CFR 70.4(i)(2)(i). As noted in the 2016 proposal, the EPA expects that program revisions to remove the title V emergency defense provisions will include, at minimum: (1) a redline document identifying the state's proposed revision to its part 70 program rules; (2) a brief statement of the legal authority authorizing the revision; and (3) a schedule and description of the state's plans to remove affirmative defense provisions from individual operating permits. The EPA encourages states to consult with their respective EPA regional offices on the specific contents of their revision submittal packages.

Regarding one commenter's statements concerning the legal authority demonstration component, the EPA reiterates that this component could take various forms depending on the specific circumstances of each state, and a formal opinion by an Attorney General should not be required for the narrow program revisions implicated by this particular rule. For a revision involving only the removal of affirmative defense provisions, a certification indicating that the revisions are within the legal authority of the agency and followed all required administrative (including public participation) requirements should be sufficient. For other program revisions related to the removal of affirmative defense provisions, such as the inclusion of a narrowly tailored enforcement discretion provision, as discussed in section IV.A.3. of this document, the legal authority demonstration should also contain assurances that the state has adequate authority to enforce its part 70 program. 62

It is unclear what the comments discussing a “revised program plan” refer to. The EPA believes that the plan described in this document, involving narrow program revision submittals to remove affirmative defense provisions, is appropriate. As noted in the 2016 proposal, states may, but need not, also include as part of their program revision submittals any other unrelated revisions to state program regulations.

Comment: Some commenters requested that the EPA clarify the consequences for states that refuse to revise their operating permit regulations. Specifically, commenters cited to CAA sections 502(d) and (i) and discussed the possibility of notices of deficiency (NOD), sanctions, and the eventual withdrawal of permitting authority.

Response: Commenters are correct that the EPA has the authority under CAA sections 502(d) and (i), and as specified in the EPA's implementing regulations at 40 CFR 70.10, to issue NODs, issue sanctions, and potentially withdraw approval of part 70 programs under appropriate circumstances, potentially including the failure of a permitting authority to submit required program revisions to the EPA. The EPA would exercise this authority on a case-by-case basis for this element of the program, as it would with any other.

Comment: In response to requests from the EPA for information about part 70 programs that contain affirmative defense provisions, various commenters discussed certain provisions in specifically identified state part 70 programs that could be impacted by the final rule. 63 Several commenters also requested an update to the document titled “Title V Affirmative Defense Provisions in State, Local, and Tribal Part 70 Programs” that was included in the docket during the 2016 rulemaking process.

Response: The EPA appreciates this additional information. As noted previously, the EPA is not taking any action in this final rule with respect to the adequacy or inadequacy of individual state programs, including specific programs identified in the 2016 document referenced by commenters. The EPA expects that permitting authorities with part 70 programs that have impermissible affirmative defense provisions will follow the process provided in section IV. of this document. EPA Regional offices will work closely with permitting authorities to provide support during this process. States with additional questions about the impact of this rule on their operating permit programs should contact the appropriate EPA Regional office for further assistance.

This section clarifies the EPA's expectations for the eventual removal of impermissible affirmative defense provisions from individual title V operating permits.

Comment: One commenter claimed that title V permits containing affirmative defenses derived from sources of authority other than 40 CFR 70.6(g) would not need to be revised.

Response: In general, any impermissible affirmative defense provisions within individual operating permits that are based on a title V authority and that apply to federally-enforceable requirements will need to be removed. For example, permit conditions that directly rely on 40 CFR 70.6(g) or 71.6(g) would need to be removed following the removal of these provisions from the EPA's regulations. Importantly, however, permit revisions would not be limited to permit conditions based on 40 CFR 70.6(g) and 71.6(g); any permit conditions that rely on a similarly impermissible title V affirmative defense provision contained in (or incorporated by reference into) a state's part 70 program would also have to be removed following state program revisions. On the other hand, and as the EPA explained in the 2016 proposal, this rule will not directly affect affirmative defense provisions contained in title V permits that are derived from independent applicable requirements, such as SIP, NSPS or NESHAP provisions. Finally, should a state decide to retain a “state-only” affirmative defense or enforcement discretion-type provision, it may need to eventually amend title V operating permits to explicitly state the limited applicability of the state-only provision. See 40 CFR 70.6(b)(2). The discussion provided in the following subsections applies to both the removal of affirmative defense provisions from permits and to the amendment or modification of such permit terms.

Comment: State commenters and one tribal commenter claimed that the EPA underestimates the burden of removing affirmative defense provisions from individual permits, and challenged the EPA's statement in the proposal that “removal of affirmative defense provisions from permits should generally occur in the ordinary course of business and should require essentially no additional burden on states and sources.” State commenters explained that thousands of existing operating permits would require some form of revision action to be processed by the state, and that revising certain general permits that apply to multiple sources would require an administrative process similar to a rulemaking.

Numerous state and industry commenters supported the EPA's suggestion that states may utilize a number of existing permit mechanisms to remove affirmative defense provisions from title V permits in the ordinary course of business, such as when the permitting authority next processes a permit renewal or significant permit modification for a source. One state commenter noted that this would be the most sensible and least disruptive and burdensome mechanism to complete permit revisions.

Commenters agreed with the EPA's initial suggestion that the removal of affirmative defense provisions from operating permits could be accomplished through the minor permit revision process and would not constitute a significant permit modification. Further, one state suggested that the EPA adopt a policy interpretation that removal of affirmative defense provisions could be accomplished through the administrative amendment process.

Some commenters also asserted that permit revisions should not be based on any other independent deadline or timeline, and that there is no urgency to remove the provisions. Other commenters, though, urged the EPA to encourage permitting authorities to exercise their discretion to remove the provisions as expeditiously as possible, on the earliest possible occasion.

Commenters also addressed the sequence of program revisions and permit revisions. One commenter expressed concern that potential ambiguity may arise if a source invokes an affirmative defense provision found in the permit, after the program revisions have been approved but the permit has not been amended. Lastly, one tribal commenter expressed its concern that making conforming revisions to permits before programmatic revisions would create inconsistencies that could undermine enforcement.

Response: The EPA acknowledges commenters' general assertions that a large number of existing title V permits across the nation will eventually need to be revised to remove title V affirmative defense provisions. However, the EPA disagrees that this will involve any extraordinary burden on states or sources. The need to occasionally revise individual title V permits is a natural, common, and required feature of the title V operating permits program. Title V operating permits, by their nature, include a wide variety of requirements applicable to a source, and permit changes are periodically necessary to incorporate new or modified applicable requirements, and to reflect physical or operational changes that occur at a source. The EPA's regulations, and all EPA-approved state part 70 programs, contain well-established mechanisms to account for various types of necessary revisions to title V permits. See, e.g., 40 CFR 70.7(d)-(h). The permit revisions that will need to occur as a result of this rulemaking fit well within this existing regulatory framework for occasional permit revisions.

Moreover, the EPA expects permit changes to remove discretionary title V affirmative defense provisions to be a potentially less burdensome process than, for example, the process required to incorporate new applicable requirements in a permit via permit reopening. See, e.g., 40 CFR 70.7(f)(1)(i). As explained in the 2016 proposal, the EPA expects that any necessary permit changes should occur in the ordinary course of business. For example, these revisions could be made when a state processes periodic permit renewals or other permit revisions. Additionally, states may utilize other existing mechanisms to effectuate these permit changes, consistent with each state's approved part 70 program regulations. For example, the EPA does not believe that a permit revision to simply remove a discretionary affirmative defense provision would require significant modification procedures, and permitting authorities may be able to process these changes as minor modifications. Also, in certain circumstances, it may be possible for some permit changes to be made using administrative permit amendment procedures, provided that the removal of the title V emergency provisions would satisfy one of the specific circumstances contemplated within each state's approved part 70 program regulations governing administrative amendments. 64 States may also be able to utilize other streamlined mechanisms for processing multiple permit revisions at once.

Regarding the timing of such permit changes, for state or tribal permitting agencies implementing the federal title V program or part 70 programs that directly rely on 40 CFR 70.6(g), any permit revisions necessary to remove impermissible affirmative defense provisions from individual permits should occur promptly after the effective date of this final rule. For states implementing part 70 programs that contain state affirmative defense provisions, any permit revisions necessary to remove impermissible affirmative defense provisions from individual permits should similarly occur promptly after the EPA's approval of the necessary part 70 program revisions. 65 Generally, states would be expected to remove title V affirmative defense provisions from permits (or clearly label remaining provisions as state-only) at the earliest possible occasion when each permit is next reviewed by the permitting authority, such as the next permit renewal or unrelated permit revision. Thus, at the latest, states would be expected to remove affirmative defense provisions from individual permits by the next periodic permit renewal that occurs following either (1) the effective date of this rule (for permit terms based on 40 CFR 70.6(g) or 71.6(g)) or (2) the EPA's approval of state program revisions (for permit terms based on a state affirmative defense provision).

It is important to note that while the EPA is not currently establishing any independent timeline for states to remove these provisions from individual permits, the EPA encourages states to begin removing these provisions from permits prior to the completion of any necessary part 70 program revisions. States may also find it convenient to remove these provisions in the course of completing revisions to permits related to the implementation of the 2015 SSM SIP Action.

Comment: Some commenters urged the EPA to make clear that the agency will object to title V permits issued after the effective date of the final rule that incorporate or refer to title V affirmative defense provisions.

Response: As previously noted, the EPA expects that any necessary permit revisions will generally occur following program revisions to remove the underlying affirmative defense provisions from each permitting authority's part 70 program regulations. Therefore, although the EPA encourages states to remove title V emergency affirmative defense provisions from operating permits at the earliest possible opportunity (including during permit renewals that occur before program revisions take place), the EPA generally does not anticipate objecting to title V permits that contain emergency affirmative defense provisions during the Agency's 45-day review period until after the relevant permitting authority has made necessary corrections to its approved part 70 program. The Administrator will evaluate any petitions to object to proposed title V operating permits on a case-by-case basis. Statements in this document are not intended to prejudge such petition responses.

As noted in section IV.B.2. of this document, in those state or tribal areas that implement the federal title V program (in 40 CFR part 71) or where the operating permit program directly relies on or incorporates by reference 40 CFR 70.6(g), the EPA expects states to begin the process of removing impermissible affirmative defense provisions from operating permits promptly after the effective date of this final rule, as such permit revisions would not need to await state program revisions.

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control numbers 2060-0243 (for part 70 state operating permit programs) and 2060-0336 (for part 71 federal operating permit program). In this action, the EPA is removing certain provisions from the EPA's regulations, which should ultimately result in the removal of similar provisions from state, local, and tribal operating permit programs and individual permits. Consequently, some states will be required to submit program revisions to the EPA in order to remove affirmative defense provisions from their EPA-approved part 70 programs, and will eventually be required to remove provisions from individual permits. However, this action does not involve any requests for information, recordkeeping or reporting requirements, or other requirements that would constitute an information collection under the PRA.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. Entities potentially affected directly by this proposal include state, local, and tribal governments, and none of these governments would qualify as a small entity. Other types of small entities, including stationary sources of air pollution, are not directly subject to the requirements of this action.

This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no new enforceable duty on any state, local or tribal governments or the private sector. As a result of this rule, some states with EPA-approved part 70 programs that contain impermissible affirmative defense provisions will be required to submit program revisions to the EPA, according to the framework established by the EPA's existing regulations. To the extent that such affected states allow local air districts or planning organizations to implement portions of the state's obligation under the CAA, the regulatory requirements of this action do not significantly or uniquely affect small governments because those governments have already undertaken the obligation to comply with the CAA.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action has tribal implications. However, it will neither impose substantial direct compliance costs on federally recognized tribal governments, nor preempt tribal law. One tribal government (the Southern Ute Indian Tribe) currently administers an approved part 70 operating permit program, and one tribal government (the Navajo Nation) currently administers a part 71 operating permit program pursuant to a delegation agreement with the EPA. These tribal governments may be required to take certain actions, including a program revision (for the part 70 program) and eventual permit revisions, but these actions will not require substantial compliance costs. The EPA conducted outreach with tribal officials early in the process of developing this regulation to permit them to have meaningful and timely input into its development. A summary of that outreach is provided in the rulemaking docket, Docket ID No. EPA-HQ-OAR-2016-0186, available at http://www.regulations.gov.

The EPA interprets Executive Order 13045 as applying to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.

This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

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

The EPA believes that it is not practicable to assess whether the human health or environmental conditions that exist prior to this action result in disproportionate and adverse effects on people of color, low-income populations and/or Indigenous peoples. This action simply removes the emergency affirmative defense provisions from the EPA's operating permit program regulations. As a result of this action, it will also be necessary for some state, local, and tribal permitting authorities to remove similar affirmative defense provisions from their EPA-approved part 70 programs and from individual title V operating permits. These title V provisions existed independently from any specific environmental health standards, and their removal should not affect the establishment of, or compliance with, environmental health or safety standards. It is not practicable to predict whether the removal of these affirmative defense provisions will result in any significant difference in emissions and subsequently whether this action will have any positive or negative effect on people of color, low-income populations and/or Indigenous peoples. Information supporting this Executive Order review is contained in section III.D.5. of this document.

The EPA provided meaningful participation opportunities for people of color, low-income populations and/or Indigenous peoples or tribes in the development of the action through tribal outreach outlined in section V.F. of this document and summarized in the rulemaking docket, Docket ID No. EPA-HQ-OAR-2016-0186, as well as the standard opportunity to provide public comment on each proposal (2016 and 2022).

This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

The statutory authority for this action is provided in CAA sections 502(b) and 502(d)(3), 42 U.S.C. 7661a(b) & (d)(3), which direct the Administrator of the EPA to promulgate regulations establishing state operating permit programs and give the Administrator the authority to establish a federal operating permit program. Additionally, the Administrator determines that this action is subject to the provisions of CAA section 307(d), which establish procedural requirements specific to rulemaking under the CAA. CAA section 307(d)(1)(V) provides that the provisions of CAA section 307(d) apply to “such other actions as the Administrator may determine.” 42 U.S.C. 7607(d)(1)(V).

Section 307(b)(1) of the CAA governs judicial review of final actions by the EPA. This section provides, in part, that petitions for review must be filed in the United States Court of Appeals for the District of Columbia Circuit: (i) when the agency action consists of “nationally applicable regulations promulgated, or final actions taken, by the Administrator,” or (ii) when such action is locally or regionally applicable, but “such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.” For locally or regionally applicable final actions, the CAA reserves to the EPA complete discretion whether to invoke the exception in (ii).

This final action is “nationally applicable” within the meaning of CAA section 307(b)(1). In the alternative, to the extent a court finds this final action to be locally or regionally applicable, the Administrator is exercising the complete discretion afforded to him under the CAA to make and publish a finding that this action is based on a determination of “nationwide scope or effect” within the meaning of CAA section 307(b)(1). 66 This final action revises both the regulatory requirements in 40 CFR part 70 that govern state, local, tribal, and U.S. territorial operating permit programs nationwide and the regulatory requirements in 40 CFR part 71 that govern federal operating permits nationwide. 67 Accordingly, this final action is a nationally applicable regulation or, alternatively, the Administrator is exercising the complete discretion afforded to him by the CAA and hereby finds that this final action is based on a determination of nationwide scope or effect for purposes of CAA section 307(b)(1) and is hereby publishing that finding in the Federal Register .

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the District of Columbia Circuit within 60 days from the date this final action is published in the Federal Register . Filing a petition for reconsideration by the Administrator of this final action does not affect the finality of the action for the purposes of judicial review, nor does it extend the time within which a petition for judicial review must be filed, and shall not postpone the effectiveness of such rule or action.

For the reasons stated in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows:

This correction fixes the amendatory instruction for 3052.204-71, Contractor employee access, to clarify that the text in Alternate II should not be removed, and adds in 3052.212-70, Contract terms and conditions applicable to DHS acquisition of commercial items, two alternative clauses that were inadvertently not included in the final rule.

In FR Doc. 2023-11270 appearing on page 40560 in the Federal Register of Wednesday, June 21, 2023, the following corrections are made:

On April 11, 2023, NMFS published a final rule approving changes to the Pacific halibut Area 2A Catch Sharing Plan and implementing recreational (sport) management measures for the 2023 Area 2A recreational fisheries (88 FR 21503), as authorized by the Northern Pacific Halibut Act of 1982 (16 U.S.C. 773-773(k)). The Pacific Fishery Management Council (Council) 2023 Catch Sharing Plan provides a recommended framework for NMFS' annual management measures and subarea allocations based on the 2023 Area 2A Pacific halibut catch limit of 1,520,000 pounds (lb) (689 metric tons (mt)) set by the International Pacific Halibut Commission (IPHC). The Area 2A catch limit and recreational fishery allocations were adopted by the IPHC and were published in the Federal Register on March 7, 2023 (88 FR 14066) after acceptance by the Secretary of State, with concurrence from the Secretary of Commerce, in accordance with 50 CFR 300.62. The Area 2A Pacific halibut management measures include recreational fishery season dates, bag limits, and subarea allocations.

Federal regulations at 50 CFR 300.63(c)(6), “Inseason Management for Recreational (Sport) Halibut Fisheries in Area 2A.,” allow the NMFS Regional Administrator to modify annual regulations during the season. These inseason provisions allow the Regional Administrator to modify recreational (sport) fishing periods, bag limits, size limits, days per calendar week, and subarea allocations, if it is determined it is necessary to meet the allocation objectives and the action will not result in exceeding the catch limit.

NMFS has determined that, due to lower than expected landings in the Washington Puget Sound, North Coast, and South Coast subareas; the Columbia River subarea; and the Oregon Central Coast subarea; inseason action to modify the 2023 annual regulations for the recreational fishery is warranted at this time to provide additional opportunity for fishery participants to achieve the Area 2A subarea allocations. As stated above, inseason modification of fishing season dates is authorized by Federal regulations at 50 CFR 300.63(c)(6). After consulting with the IPHC, the Council, the Washington Department of Fish and Wildlife (WDFW), and the Oregon Department of Fish and Wildlife (ODFW), NMFS determined the following inseason actions are necessary to meet the management objective of attaining subarea allocations, will not result in exceeding any subarea allocations, and are consistent with the inseason management provisions allowing for the modification of recreational fishing periods and recreational fishing days per calendar week. Notice of these additional dates and increased bag limits will also be announced on the NMFS hotline at 206-526-6667 or 800-662-9825.

Weekly catch monitoring reports for the recreational fisheries in Washington, Oregon, and California are available on their respective state Fish and Wildlife agency websites. NMFS and the IPHC will continue to monitor recreational catch obtained via state sampling procedures until NMFS has determined there is not sufficient allocation for another full day of fishing, and the area is closed by the IPHC, or the season closes on September 30 in Washington and the Columbia River subarea or October 31 in Oregon, whichever is earlier.

Description of the action: This inseason action implements additional fishing dates for the Washington Puget Sound, North Coast, and South Coast subareas during the 2023 recreational fishery. The Puget Sound subarea will open 7 days per week beginning on August 16 and will close when the subarea allocation is projected to be attained, or on September 30, whichever comes first. The North Coast subarea will open 7 days per week beginning on August 16 and close when the subarea allocation is projected to be attained, or on September 30, whichever comes first. The South Coast subarea will open on August 26 and 27, and September 8, 9, and 22, or until there is not sufficient allocation for another full day of fishing and the area is therefore closed.

Reason for the action: The purpose of this inseason action is to provide additional opportunity for anglers in the Washington Puget Sound, North Coast, and South Coast subareas to achieve the subarea allocations. NMFS has determined that these additional dates are warranted due to lower than expected landings through June 18, and the expectation that a substantial amount of the Washington allocation will go unharvested without additional fishing dates.

The Washington Puget Sound subarea will open 7 days per week beginning August 16 and will remain open until September 30 or the allocation is projected to be attained and the area is therefore closed. The recreational fishery in this subarea opened on April 6, 2023. As of June 18, anglers in the Puget Sound subarea have harvested 34,606 lb (15.70 mt) of the 79,031 lb (35.85 mt) allocation (44 percent), leaving 44,425 lb (20.15 mt) remaining (66 percent of the subarea allocation).

The Washington North Coast subarea will open 7 days per week beginning August 16 and will remain open until September 30 or the allocation is projected to be attained and the area is therefore closed. The recreational fishery in this subarea opened on May 4, 2023. As of June 18, anglers in the North Coast subarea have harvested 54,702 lb (24.81 mt) of the 129,668 lb (58.82 mt) allocation (42 percent), leaving 74,966 lb (34.00 mt) remaining (68 percent of the subarea allocation).

The Washington South Coast subarea will open August 26 and 27, and September 8, 9, and 22 or the allocation is projected to be attained and the area is therefore closed. The recreational fishery in this subarea opened on May 4, 2023. As of June 18, anglers in the South Coast subarea have harvested 43,159 lb (19.58 mt) of the 64,376 lb (29.20 mt) allocation (67 percent), leaving 21,217 lb (9.62 mt) remaining (33 percent of the subarea allocation).

After consulting with WDFW, it was determined that in order for anglers to have the opportunity to achieve the Washington subarea allocations, with little risk of the subareas or coastwide allocation being exceeded, additional fishing dates are warranted. Therefore, through this action, NMFS is announcing fishing dates in August and September that were not previously implemented in the final rule on April 11, 2023 (88 FR 21503) or through inseason action implemented on June 2, 2023 (88 FR 36973).

Specifically, the additional season dates for the Puget Sound subarea are August 16 through September 30 or until there is not sufficient allocation for another full day of fishing and the area is therefore closed. The additional dates for the North Coast subarea as August 16 through September 30 or until there is not sufficient allocation for another full day of fishing and the area is therefore closed. The additional dates for the South Coast subarea are August 26 and 27, and September 8, 9, and 22, or until there is not sufficient allocation for another full day of fishing and the area is therefore closed.

Notice of these additional dates will also be announced on the NMFS hotline at 206-526-6667 or 800-662-9825.

Description of the action: This inseason action implements additional fishing dates for the Columbia River subarea during the 2023 recreational fishery, opening the fishery on August 26 and 27, and September 8, 9, and 22. The subarea may close sooner if there is projected to be insufficient allocation for another full day of fishing and the subarea is therefore closed.

Reason for the action: The purpose of this inseason action is to provide additional opportunity for anglers in the Columbia River subarea to achieve the subarea allocation. NMFS has determined that these additional dates are warranted due to lower than expected landings through June 18, and the expectation that a substantial amount of the Columbia River subarea allocation will go unharvested without additional fishing dates. The recreational fishery in this subarea opened on May 4, 2023. As of June 18, anglers in the Columbia River subarea have harvested 12,213 lb (5.54 mt) of the 18,875 lb (8.56 mt) allocation (65 percent), leaving 6,661 lb (3.02 mt) remaining (35 percent of the subarea allocation).

After consulting with WDFW and ODFW, it was determined that in order for anglers to have the opportunity to achieve the Columbia River subarea allocation, with little risk of the subarea or coastwide allocation being exceeded, additional fishing dates are warranted. Therefore, through this action, NMFS is announcing fishing dates in August and September that were not previously implemented in the final rule on April 11, 2023 (88 FR 21503, April 11, 2023) or through inseason action implemented on June 2, 2023 (88 FR 36973).

Specifically, the additional season dates for the Columbia River subarea are August 26 and 27, and September 8, 9, and 22. The subarea may close sooner if there is projected to be insufficient allocation for another full day of fishing and the subarea is therefore closed.

Notice of these additional dates will also be announced on the NMFS hotline at 206-526-6667 or 800-662-9825.

Description of the action: This inseason action implements additional fishing dates for the Oregon Central Coast subarea during the 2023 recreational fishery, opening the fishery 7 days per week beginning on August 3 and closing when the entire Oregon Central Coast allocation (including the nearshore allocation) is projected to be reached, or on October 31, whichever comes first.

Reason for the action: The purpose of this inseason action is to provide additional opportunity for anglers in the Oregon Central Coast subarea to achieve the subarea allocation. NMFS has determined that additional fishing days are warranted due to lower than expected landings through June 18, 2023, and the expectation that a substantial amount of the Oregon combined allocation will go unharvested without additional fishing days. The recreational fishery in this subarea opened on May 1, 2023. As of June 18, anglers in the Oregon Central Coast subarea have harvested 98,342 lb (44.61 mt) of the 275,214 lb (124.84 mt) allocation (36 percent), leaving 176,872 lb (80.23 mt) remaining (64 percent of the overall subarea allocation).

After consulting with ODFW, it was determined that in order for anglers to have the opportunity to achieve the overall Central Coast subarea allocation, with little risk of the subarea or coastwide allocation being exceeded, additional fishing dates are warranted. Therefore, through this action, NMFS is announcing fishing dates in August, September, and October that were not previously implemented in the final rule on April 11, 2023 (88 FR 21503) or through inseason action implemented on June 2, 2023 (88 FR 36973).

Notice of these additional fishing dates will also be announced on the NMFS hotline at 206-526-6667 or 800-662-9825.

NMFS issues this action pursuant to the Northern Pacific Halibut Act of 1982. This action is taken under the regulatory authority at 50 CFR 300.63(c)(6), and is exempt from review under Executive Order 12866.

Pursuant to 5 U.S.C. 553(b)(3)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest. WDFW and ODFW provided updated landings data to NMFS on June 23, 2023, showing that through June 18, fishery participants in the recreational fishery off of Washington had caught only 44 percent of the Puget Sound subarea allocation, 42 percent of the North Coast subarea allocation, and 67 percent of the South Coast subarea allocation; fishery participants in the Columbia River subarea had caught only 65 percent of the subarea allocation; and fishery participants in the recreational fishery off of Oregon had caught only 36 percent of Central Coast subarea allocation. NMFS uses fishing rates from previous years to determine the number of recreational fishing dates needed to attain subarea allocations. Given the lower than expected catch rates in the Washington Puget Sound, North Coast, and South Coast subareas; the Columbia River subarea; and the Oregon Central Coast subarea, additional dates are considered necessary to increase angler opportunity to reach the overall Washington and Oregon subarea allocations. This action should be implemented as soon as possible to allow fishery participants to take advantage of the additional season dates. As the fisheries close on September 30, 2023 in Washington and the Columbia River subareas and on October 31, 2023 in Oregon, implementing this action through proposed and final rulemaking would limit the benefit this action would provide to fishery participants. Without implementation of additional season dates in the Washington Puget Sound, North Coast, and South Coast subareas, the Columbia River subarea, and the Oregon Central Coast, the overall Washington and Oregon allocations are unlikely to be harvested, limiting economic benefits to the participants and not meeting the goals of the Catch Sharing Plan. It is necessary that this rulemaking be implemented in a timely manner so that planning for additional season dates can take place, and for business and personal decision making by the regulated public impacted by this action, which includes recreational charter fishing operations, associated port businesses, and private anglers who do not live near the coastal access points for this fishery, among others. To ensure the regulated public is fully aware of this action, notice of this regulatory action will also be provided to anglers through a telephone hotline, news release, and by the relevant state fish and wildlife agencies. NMFS will receive public comments for 15 days after publication of this action, in accordance with 50 CFR 300.63(c)(6)(iv). No aspect of this action is controversial, and changes of this nature were anticipated in the process described in regulations at 50 CFR 300.63(c).

For the reasons discussed above, there is also good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effective date and make this action effective immediately upon filing for public inspection, as a delay in effectiveness of this action would constrain fishing opportunity and be inconsistent with the goals of the Catch Sharing Plan, as well as potentially limit the economic opportunity intended by this rule to the associated fishing communities. This inseason action is not expected to result in exceeding the allocation for these subareas. NMFS regulations allow the Regional Administrator to modify sport fishing periods, bag limits, size limits, days per calendar week, and subarea allocations, provided that the action allows allocation objectives to be met and will not result in exceeding the catch limit for the subarea. NMFS recently received information on the progress of landings in the recreational fisheries in Washington and Oregon subareas, indicating additional season dates for Washington and Oregon should be implemented in the fishery to ensure optimal harvest of the subarea allocations. As stated above, it is in the public interest that this action is not delayed, because a delay in the effectiveness of these new dates would not allow the allocation objectives of the recreational Pacific halibut fishery to be met.

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2023 total allowable catch (TAC) of Pacific cod allocated to catcher/processors using trawl gear in the Central Regulatory Area of the GOA is 462 metric tons as established by the final 2023 and 2024 harvest specifications for groundfish of the GOA (88 FR 13238, March 2, 2023).

In accordance with § 679.20(d)(2), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2023 TAC of Pacific cod allocated to catcher/processors using trawl gear in the Central Regulatory Area of the GOA has been reached. Therefore, NMFS is requiring that Pacific cod caught by catcher/processors using trawl gear in the Central Regulatory Area of the GOA be treated as prohibited species in accordance with § 679.21(a)(2).

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR part 679, which was issued pursuant to section 304(b), and is exempt from review under Executive Order 12866.

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay prohibiting the retention of Pacific cod by catcher/processors using trawl gear in the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of July 17, 2023.

The Assistant Administrator for Fisheries, NOAA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.