The RUS published a final rule with request for comments in the Federal Register on September 10, 2021 at 86 FR 50604. The final rule modified existing regulations to implement statutory provisions of the Agriculture Improvement Act of 2018 (2018 Farm Bill).

The comment period on the final rule closed November 9, 2021. Comments were received from five respondents. The comments provided and Agency responses are as follows:

Respondent one is an individual that offered general comments on the importance of connectivity and how it can benefit rural areas and farmers.

Agency Response: Thank you for your comment.

Respondent two is a small company located in Kansas that started up specifically to offer broadband service with a grant through a COVID-19 response program. The company had to take on additional debt in order to expand their service and have provided general comments on their experience with providing service to a small area and the challenges they continue to face. They “would like to see refinancing limits to 100 percent loans and 50 percent for non-RUS loans.” They express the need for easier access to capital for network upgrades.

Agency Response: Thank you for your comment.

Respondent three is an organization that represents its member telecommunications companies and advocates on their behalf. They provided a general discussion on the changes made to the regulation and offered the following: “The proposed rules for implementing the changes to the Rural Telephone Loan Program represent a good faith and commendable effort to carry out the will of Congress expressed in the 2018 Farm Bill, and USDA has the benefit of decades of experience (and countless success stories) at RUS in supporting rural telecom and coordinating with other federal programs. As RUS begins administering the revamped program, however, it will be important to recommit to such efforts, including identifying where providers are receiving USF or other program support to deploy to at least the RUS broadband standard, and limiting future USDA awards in those areas to the recipients of support or funding from these other programs instead of duplicating the existing network and putting scarce federal resources at risk.”

As part of their concern for identifying where existing providers are located, they recommended adding to § 1735.12 on nonduplication “that such loan will not results in duplication of lines, facilities, or systems that are obligated to be built in the area in question to provide reasonably adequate services under other programs administered by the Agency or any other federal Agency.”

Agency Response: The Agency supports the respondent's comment and the Agency meets with other federal agencies that support the deployment of broadband facilities on a regular basis. We appreciate your suggestion and will keep it under consideration for a future change to the regulation. As the Agency works with our other federal partners, we will develop an overall strategy that ensures the most efficient use of all federal dollars allocated to providing broadband service.

Respondent four is an existing Native American RUS borrower that has been in operation over 60 years. They have outstanding loans in the telecommunications and broadband programs. They “strongly support the included federal rule amendments and urge their expeditious implementation by the RUS.” In support of and relating to these changes, the company offered a detailed summary of their existing operations and their hard work in providing modern, state-of-the-art telecommunications services to its customers. Their broadband penetration “sits at approximately 58 percent and while the company understands the importance of making its broadband services more affordable, it has been unable to reduce its pricing given financial, cost recovery needs. As a small company providing broadband and voice services over a large, remote, and thinly populated area, the company faces significant cost recovery challenges.” In recognition of their cost recovery and price affordability concerns, they have been in discussions with the Agency on extensions, revised loan terms or full refinancing options.

As to implementation of the final rule and issuance of the referenced funding opportunity announcement, “the borrower urges RUS to move swiftly in its process, issuing the required public notice at the earliest opportunity. Furthermore, the company requests that the RUS in making funds available for refinancing establish a process for receiving and reviewing applications that fairly takes into account the interest of the company and other service providers.”

In its summary, the borrower “urges the RUS to sufficiently clarify within the released Notice of Funding Opportunity the differences in the informational requirements, review processes and the estimated timelines that will apply with respect to the RUS review of refinance applications vs. original loan applications. Also, given the informational requirements and steps necessary for full review and final action by the RUS should not be as extensive for refinance applications, the borrower encourages the RUS to implement a timeline for its acceptance and review of refinance applications that is different than, and much shorter, that the timelines will be established for the submittal, review and action on applications for new infrastructure loans.”

Agency response: The Agency is in the final phase of the funding announcement to open the Infrastructure Program to the new refinancing opportunities. The funding announcement will include the requirements that need to be satisfied to receive the refinancing. Applications will be processed as soon as they are submitted.

Respondent five is a national trade association that represents small, rural telecommunications providers across rural America. Many of the rural location exchange carriers they represent have a long-standing relationship with the Agency going back more than 75 years. The respondent “supports RUS' efforts that streamline the Loan Program and eliminate unnecessary requirements so that the Program operates more efficiently. In addition, the respondent supports some of the more substantive changes made to the Loan Program rules. Specifically, creating a minimum retail broadband service speed standard of 25/3 Mbps will help ensure rural areas are not left behind more populated areas when it comes to broadband service. In addition, broader loan restructuring and refinancing authority will allow RUS borrowers to take advantage of better interest rates. Finally, the creation of a public notice requirement for loan applications will help ensure funds are not used to duplicate existing networks; however, RUS should strengthen this provision by directly contacting incumbent service providers to let them know of a submitted application.”

Agency response: The Agency believes that the public notice requirements, set out by statute, sufficiently put incumbent service providers on notice that an application has been submitted under any program at USDA for retail broadband assistance.

The Agency did not receive any significant adverse comments during the public comment period on the final rule, and therefore confirms the rule without change.

TELEGRID Technologies, Inc. (TELEGRID) applied to the FAA on February 24, 2020, for a special class type certificate under Title 14, Code of Federal Regulations (14 CFR) 21.17(b) for the Model TELEGRID DE2020 unmanned aircraft system (UAS).

The Model TELEGRID DE2020 consists of a rotorcraft UA and its associated elements (AE) including communication links and components that control the UA. The Model TELEGRID DE2020 UA has a maximum gross takeoff weight of 24 pounds. It is approximately 39 inches in width, 39 inches in length, and 17 inches in height. The Model TELEGRID DE2020 UA uses battery-powered electric motors for vertical takeoff, landing, and forward flight. The UAS operations would rely on high levels of automation and may include multiple UA operated by a single pilot, up to a ratio of 20 UA to 1 pilot. TELEGRID anticipates operators will use the Model TELEGRID DE2020 for delivering packages. The proposed concept of operations (CONOPS) for the Model TELEGRID DE2020 identifies a maximum operating altitude of 400 feet above ground level (AGL), a maximum cruise speed of 22 knots (25 mph), operations beyond visual line of sight (BVLOS) of the pilot, and operations over human beings. TELEGRID has not requested type certification for flight into known icing for the Model TELEGRID DE2020.

The FAA issued a notice of proposed airworthiness criteria for the TELEGRID DE2020 UAS, which published in the Federal Register on November 20, 2020 (85 FR 74289).

Based on the comments received, these final airworthiness criteria reflect the following changes, as explained in more detail under Discussion of Comments: A new section containing definitions; revisions to the CONOPS requirement; changing the term “critical part” to “flight essential part” in D&R.135; changing the basis of the durability and reliability testing from population density to limitations prescribed for the operating environment identified in the applicant's CONOPS per D&R.001; and, for the demonstration of certain required capabilities and functions as required by D&R.310.

Additionally, the FAA re-evaluated its approach to type certification of low-risk UA using durability and reliability testing. Safe UAS operations depend and rely on both the UA and the AE. As explained in FAA Memorandum AIR600-21-AIR-600-PM01, dated July 13, 2021, the FAA has revised the airworthiness criteria to define a boundary between the UA type certification and subsequent operational evaluations and approval processes for the UAS ( i.e., waivers, exemptions, and/or operating certificates).

To reflect that these airworthiness criteria rely on durability and reliability (D&R) testing for certification, the FAA changed the prefix of each section from “UAS” to “D&R.”

Lastly, the FAA revised D&R.001(g) to clarify that the operational parameters listed in that paragraph are examples and not an all-inclusive list.

The FAA received responses from 15 commenters. The majority of commenters were individuals. In addition to the individuals' comments, the FAA also received comments from the European Union Aviation Safety Agency (EASA), unmanned aircraft manufacturers, a helicopter operator, and organizations such as the Air Line Pilots Association (ALPA), Droneport Texas, LLC, the National Agricultural Aviation Association (NAAA), Northeast UAS Airspace Integration Research Alliance, Inc. (NUAIR), and the Small UAV Coalition.

Comment Summary: ALPA, NUAIR, and the Small UAV Coalition expressed support for type certification as a special class of aircraft and establishing airworthiness criteria under § 21.17(b). The Small UAV Coalition also supported the FAA's proposed use of performance-based standards.

Comment Summary: An individual commenter requested the FAA define the term “loss of flight” and clarify how it is different from “loss of control.” The commenter questioned whether loss of flight meant the UA could not continue its intended flight plan but could safely land or terminate the flight.

FAA Response: The FAA has added a new section, D&R.005, to define the terms “loss of flight” and “loss of control” for the purposes of these airworthiness criteria. “Loss of flight” refers to a UA's inability to complete its flight as planned, up to and through its originally planned landing. “Loss of flight” includes scenarios where the UA experiences controlled flight into terrain or obstacles, or any other collision, or a loss of altitude that is severe or non-recoverable. “Loss of flight” includes deploying a parachute or ballistic recovery system that leads to an unplanned landing outside the operator's designated recovery zone.

“Loss of control” means an unintended departure of an aircraft from controlled flight. It includes control reversal or an undue loss of longitudinal, lateral, and directional stability and control. It also includes an upset or entry into an unscheduled or uncommanded attitude with high potential for uncontrolled impact with terrain. “Loss of control” means a spin, loss of control authority, loss of aerodynamic stability, divergent flight characteristic, or similar occurrence, which could generally lead to a crash.

Comment Summary: Two commenters requested the FAA clarify terminology with respect to piloting skill and alertness. Droneport Texas LLC stated that the average pilot skill and alertness is currently undefined, as remote pilots do not undergo oral or practical examinations to obtain certification. NUAIR noted that, despite the definition of “exceptional piloting skill and alertness” in Advisory Circular (AC) 23-8C, Flight Test Guide for Certification of Part 23 Airplanes, there is a significant difference between the average skill and alertness of a remote pilot certified under 14 CFR part 107 and a pilot certified under 14 CFR part 61. The commenter requested the FAA clarify the minimum qualifications and ratings to perform as a remote pilot of a UAS with a type certificate.

FAA Response: These airworthiness criteria do not require exceptional piloting skill and alertness for testing. The FAA included this as a requirement to ensure the applicant passes testing by using pilots of average skill who have been certificated under part 61, as opposed to highly trained pilots with thousands of hours of flight experience.

The FAA proposed a requirement for the applicant to submit a CONOPS describing the UAS and identifying the intended operational concepts. The FAA explained in the preamble of the notice of proposed airworthiness criteria that the information in the CONOPS would determine parameters for testing and flight manual operating limitations.

Comment Summary: One commenter stated that the airworthiness criteria are generic and requested the FAA add language to proposed UAS.001 to clarify that some of the criteria may not be relevant or necessary.

FAA Response: Including the language requested by the commenter would be inappropriate, as these airworthiness criteria are project-specific. Thus, in this case, each element of these airworthiness criteria is a requirement specific to the type certification of TELEGRID's proposed UA design.

Comment Summary: ALPA requested the criteria specify that the applicant's CONOPS contain sufficient detail to determine the parameters and extent of testing, as well as operating limitations placed on the UAS for its operational uses.

FAA Response: The FAA agrees and has updated D&R.001 to clarify that the information required for inclusion in the CONOPS proposal (D&R.001(a) through (g)) must be described in sufficient detail to determine the parameters and extent of testing and operating limitations.

Comment Summary: ALPA requested the CONOPS include a description of a means to ensure separation from other aircraft and perform collision avoidance maneuvers. ALPA stated that its requested addition to the CONOPS is critical to the safety of other airspace users, as manned aircraft do not easily see most UAs.

FAA Response: The FAA agrees and has updated D&R.001 to require that the applicant identify collision avoidance equipment (whether onboard the UA or part of the AE), if the applicant requests to include that equipment.

Comment Summary: ALPA requested the FAA add security-related (other than cyber-security) requirements to the CONOPS criteria, including mandatory reporting of security occurrences, security training and awareness programs for all personnel involved in UAS operations, and security standards for the transportation of goods, similar to those for manned aviation.

FAA Response: The type certificate only establishes the approved design of the UA. Operations and operational requirements, including those regarding security occurrences, security training, and package delivery security standards (other than cybersecurity airworthiness design requirements) are beyond the scope of the airworthiness criteria established by this document and are not required for type certification.

Comment Summary: UAS.001(c) proposed to require that the applicant's CONOPS include a description of meteorological conditions. ALPA requested the FAA change UAS.001(c) to require a description of meteorological and environmental conditions and their operational limits. ALPA stated the CONOPS should include maximum wind speeds, maximum or minimum temperatures, maximum density altitudes, and other relevant phenomena that will limit operations or cause operations to terminate.

FAA Response: D&R.001(c) and D&R.125 address meteorological conditions, while D&R.001(g) addresses environmental considerations. The FAA determined that these criteria are sufficient to cover the weather phenomena mentioned by the commenter without specifically requiring identification of related operational limits.

To address the risks associated with loss of control of the UA, the FAA proposed that the applicant design the control station to provide the pilot with all information necessary for continued safe flight and operation.

Comment Summary: ALPA and two individual commenters requested the FAA revise the proposed criteria to add requirements for the control station. Specifically, these commenters requested the FAA include the display of data and alert conditions to the pilot, physical security requirements for both the control station and the UAS storage area, design requirements that minimize negative impact of extended periods of low pilot workload, transfer of control between pilots, and human factors/human machine interface considerations for handheld controls. NUAIR requested the FAA designate the control station as a flight critical component for operations.

EASA and an individual commenter requested the FAA consider flexibility in some of the proposed criteria. EASA stated that the list of information in proposed UAS.100 is too prescriptive and contains information that may not be relevant for highly automated systems. The individual commenter requested that the FAA allow part-time or non-continuous displays of required information that do not influence the safety of the flight.

FAA Response: Although the scope of the proposed airworthiness criteria applied to the entire UAS, the FAA has re-evaluated its approach to type certification of low-risk unmanned aircraft using durability and reliability testing. A UA is an aircraft that is operated without the possibility of direct human intervention from within or on the aircraft. 1 A UAS is defined as a UA and its AE, including communication links and the components that control the UA, that are required to operate the UAS safely and efficiently in the national airspace system. 2 As explained in FAA Memorandum AIR600-21-AIR-600-PM01, dated July 13, 2021, the FAA determined it will apply the regulations for type design approval, production approval, conformity, certificates of airworthiness, and maintenance to only the UA and not to the AE. However, because safe UAS operations depend and rely on both the UA and the AE, the FAA will consider the AE in assessing whether the UA meets the airworthiness criteria that comprise the certification basis.

While the AE items themselves will be outside the scope of the UA type design, the applicant will provide sufficient specifications for any aspect of the AE, including the control station, which could affect airworthiness. The FAA will approve either the specific AE or minimum specifications for the AE, as identified by the applicant, as part of the type certificate by including them as an operating limitation in the type certificate data sheet and flight manual. The FAA may impose additional operating limitations specific to the AE through conditions and limitations for inclusion in the operational approval ( i.e., waivers, exemptions, or a combination of these). In accordance with this approach, the FAA will consider the entirety of the UAS for operational approval and oversight.

Accordingly, the FAA has revised the criteria by replacing proposed section UAS.100, applicable to the control station design, with D&R.100, UA Signal Monitoring and Transmission, with substantively similar criteria that apply to the UA design.

The FAA has also added a new section, D&R.105, UAS AE Required for Safe UA Operations, which requires the applicant to provide information concerning the specifications of the AE. The FAA has moved the alert function requirement proposed in UAS.100(a) to new section D&R.105(a)(1)(i). As part of the clarification of the testing of the interaction between the UA and AE, the FAA has added a requirement to D&R.300(h) for D&R testing to use minimum specification AE. This addition requires the applicant to demonstrate that the limits proposed for those AE will allow the UA to operate as expected throughout its service life. Finally, the FAA has revised references throughout the airworthiness criteria from “UAS” to “UA,” as appropriate, to reflect the FAA determination that the regulations for type design approval, production approval, conformity, certificates of airworthiness, and maintenance apply to only the UA.

The FAA proposed criteria on verification, configuration management, and problem reporting to minimize the existence of errors associated with UAS software.

Comment Summary: ALPA requested the FAA add language to the proposed criteria to ensure that some level of software engineering principles are used without being too prescriptive.

FAA Response: By combining the software testing requirement of D&R.110(a) with successful completion of the requirements in the entire “Testing” subpart, the acceptable level of software assurance will be identified and demonstrated. The configuration management system required by D&R.110(b) will ensure that the software is adequately documented and traceable both during and after the initial type certification activities.

Comment Summary: EASA suggested the criteria require that the applicant establish and correctly implement system requirements or a structured software development process for critical software.

FAA Response: Direct and specific evaluation of the software development process is more detailed than what the FAA intended with the proposed criteria, which use D&R testing to evaluate the UAS as a whole system, rather than evaluating individual components within the UA. Successful completion of the testing requirements provides confidence that the components that make up the UA provide an acceptable level of safety, commensurate to the low-risk nature of this aircraft. The FAA finds no change to the airworthiness criteria is needed.

Comment Summary: Two individual commenters requested the FAA require the manned aircraft software certification methodology in RTCA DO-178C, Software Considerations in Airborne Systems and Equipment Certification, for critical UA software.

FAA Response: Under these airworthiness criteria, only software that may affect the safe operation of the UA must be verified by test. To verify by test, the applicant will need to provide an assessment showing that other software is not subject to testing because it has no impact on the safe operation of the UA. For software that is subject to testing, the FAA may accept multiple options for software qualification, including DO-178C. Further, specifying that applicants must comply with DO-178 would be inconsistent with the FAA's intent to issue performance-based airworthiness criteria.

Comment Summary: NAAA stated that an overreliance of software in aircraft has been and continues to be a source of accidents and requested the FAA include criteria to prevent a midair collision.

FAA Response: The proper functioning of software is an important element of type certification, particularly with respect to flight controls and navigation. The airworthiness criteria in D&R.110 are meant to provide an acceptable level of safety commensurate with the risk posed by this UA. Additionally, the airworthiness criteria require contingency planning per D&R.120 and the demonstration of the UA's ability to detect and avoid other aircraft in D&R.310, if requested by the applicant. The risk of a midair collision will be minimized by the operating limitations that result from testing based on the operational parameters identified by the applicant in its CONOPS (such as geographic operating boundaries, airspace classes, and congestion of the proposed operating area), rather than by specific mitigations built into the aircraft design itself. These criteria are sufficient due to the low-risk nature of the TELEGRID DE2020.

Because the UA requires a continuous wireless connection, the FAA proposed criteria to address the risks to the UAS from cybersecurity threats.

Comment Summary: ALPA requested adding a requirement for cybersecurity protection for navigation and position reporting systems such as Global Navigation Satellite System (GNSS). ALPA further requested the FAA include criteria to address specific cybersecurity vulnerabilities, such as jamming (denial of signal) and spoofing (false position data is inserted). ALPA stated that, for navigation, UAS primarily use GNSS—an unencrypted, open-source, low power transmission that can be jammed, spoofed, or otherwise manipulated.

FAA Response: The FAA will assess elements directly influencing the UA for cybersecurity under D&R.115 and will assess the AE as part of any operational approvals an operator may seek. D&R.115 (proposed as UAS.115) addresses intentional unauthorized electronic interactions, which includes, but is not limited to, hacking, jamming, and spoofing. These airworthiness criteria require the high-level outcome the UA must meet, rather than discretely identifying every aspect of cybersecurity the applicant will address.

The FAA proposed criteria requiring that the UAS be designed to automatically execute a predetermined action in the event of a loss of communication between the pilot and the UA. The FAA further proposed that the predetermined action be identified in the Flight Manual and that the UA be precluded from taking off when the quality of service is inadequate.

Comment Summary: ALPA requested the criteria encompass more than loss or degradation of the command and control (C2) link, as numerous types of critical part or systems failures can occur that include degraded capabilities, whether intermittent or sustained. ALPA requested the FAA add language to the proposed criteria to address specific failures such as loss of a primary navigation sensor, degradation or loss of navigation capability, and simultaneous impact of C2 and navigation links.

FAA Response: The airworthiness criteria address the issues raised by the commenter. Specifically, D&R.120(a) addresses actions the UA will automatically and immediately take when the operator no longer has control of the UA. Should the specific failures identified by ALPA result in the operator's loss of control, then the criteria require the UA to execute a predetermined action. Degraded navigation performance does not raise the same level of concern as a degraded or lost C2 link. For example, a UA may experience interference with a GPS signal on the ground, but then find acceptable signal strength when above a tree line or other obstruction. The airworthiness criteria require that neither degradation nor complete loss of GPS or C2, as either condition would be a failure of that system, result in unsafe loss of control or containment. The applicant must demonstrate this by test to meet the requirements of D&R.305(a)(3).

Under the airworthiness criteria, the minimum performance requirements for the C2 link, defining when the link is degraded to an unacceptable level, may vary among different UAS designs. The level of degradation that triggers a loss is dependent upon the specific UA characteristics; this level will be defined by the applicant and demonstrated to be acceptable by testing as required by D&R.305(a)(2) and D&R.310(a)(1).

Comment Summary: An individual commenter requested the FAA use distinct terminology for “communication,” used for communications with air traffic control, and “C2 link,” used for command and control between the remote pilot station and UA. The commenter questioned whether, in the proposed criteria, the FAA stated “loss of communication between the pilot and the UA” when it intended to state “loss of C2 link.”

FAA Response: Communication extends beyond the C2 link and specific control inputs. This is why D&R.001 requires the applicant's CONOPS to include a description of the command, control, and communications functions. As long as the UA operates safely and predictably per its lost link contingency programming logic, a C2 interruption does not constitute a loss of control.

The FAA proposed criteria to address the risks that would result from a lightning strike, accounting for the size and physical limitations of a UAS that could preclude traditional lightning protection features. The FAA further proposed that without lightning protection for the UA, the Flight Manual must include an operating limitation to prohibit flight into weather conditions with potential lightning.

Comment Summary: An individual requested the FAA revise the criteria to include a similar design mitigation or operating limitation for High Intensity Radiated Fields (HIRF). The commenter noted that HIRF is included in proposed UAS.300(e) as part of the expected environmental conditions that must be replicated in testing.

FAA Response: The airworthiness criteria, which are adopted as proposed, address the issue raised by the commenter. The applicant must identify tested HIRF exposure capabilities, if any, in the Flight Manual to comply with the criteria in D&R.200(a)(5). Information regarding HIRF capabilities is necessary for safe operation because proper communication and software execution may be impeded by HIRF-generated interference, which could result in loss of control of the UA. It is not feasible to measure HIRF at every potential location where the UA will operate; thus, requiring operating limitations for HIRF as requested by the commenter would be impractical.

The FAA proposed criteria either requiring that design characteristics protect the UAS from adverse weather conditions or prohibiting flight into known adverse weather conditions. The criteria proposed to define adverse weather conditions as rain, snow, and icing.

Comment Summary: ALPA and two individual commenters requested the FAA expand the proposed definition of adverse weather conditions. These commenters noted that because of the size and physical limitations of the Model TELEGRID DE2020, adverse weather should also include wind, downdraft, low-level wind shear (LLWS), microburst, and extreme mechanical turbulence.

FAA Response: No additional language needs to be added to the airworthiness criteria to address wind effects. The wind conditions specified by the commenters are part of normal UA flight operations. The applicant must demonstrate by flight test that the UA can withstand wind without failure to meet the requirements of D&R.300(b)(9). The FAA developed the criteria in D&R.130 to address adverse weather conditions (rain, snow, and icing) that would require additional design characteristics for safe operation. Any operating limitations necessary for operation in adverse weather or wind conditions will be included in the Flight Manual as required by D&R.200.

Comment Summary: One commenter questioned whether the criteria proposed in UAS.130(c)(2), requiring a means to detect adverse weather conditions for which the UAS is not certificated to operate, is a prescriptive requirement to install an onboard detection system. The commenter requested, if that was the case, that the FAA allow alternative procedures to avoid flying in adverse weather conditions.

FAA Response: The language referred to by the commenter is not a prescriptive design requirement for an onboard detection system. The applicant may use any acceptable source to monitor weather in the area, whether onboard the UA or from an external source.

The FAA proposed criteria for critical parts that were substantively the same as those in the existing standards for normal category rotorcraft under § 27.602, with changes to reflect UAS terminology and failure conditions. The criteria proposed to define a critical part as a part, the failure of which could result in a loss of flight or unrecoverable loss of control of the aircraft.

Comment Summary: EASA requested the FAA avoid using the term “critical part,” as it is a well-established term for complex manned aircraft categories and may create incorrect expectations on the oversight process for parts.

FAA Response: For purposes of the airworthiness criteria established for the TELEGRID Model TELEGRID DE2020, the FAA has changed the term “critical part” to “flight essential part.”

Comment Summary: An individual commenter requested the FAA revise the proposed criteria such that a failure of a flight essential part would only occur if there is risk to third parties.

FAA Response: The definition of “flight essential” does not change regardless of whether on-board systems are capable of safely landing the UA when it is unable to continue its flight plan. Tying the definition of a flight essential part to the risk to third parties would result in different definitions for the part depending on where and how the UA is operated. These criteria for the Model TELEGRID DE2020 UA apply the same approach as for manned aircraft.

The FAA proposed criteria for the Flight Manual that were substantively the same as the existing standards for normal category airplanes, with minor changes to reflect UAS terminology.

Comment Summary: ALPA requested the FAA revise the criteria to include normal, abnormal, and emergency operating procedures along with their respective checklist. ALPA further requested the checklist be contained in a quick reference handbook (QRH).

FAA Response: The FAA did not intend for the airworthiness criteria to exclude abnormal procedures from the flight manual. In these final airworthiness criteria, the FAA has changed “normal and emergency operating procedures” to “operating procedures” to encompass all operating conditions and align with 14 CFR 23.2620, which includes the airplane flight manual requirements for normal category airplanes. The FAA has not made any changes to add language that would require the checklists to be included in a QRH. FAA regulations do not require manned aircraft to have a QRH for type certification. Therefore, it would be inconsistent for the FAA to require a QRH for the TELEGRID Model TELEGRID DE2020 UA.

Comment Summary: ALPA requested the FAA revise the airworthiness criteria to require that the Flight Manual and QRH be readily available to the pilot at the control station.

FAA Response: ALPA's request regarding the Flight manual addresses an operational requirement, similar to 14 CFR 91.9 and is therefore not appropriate for type certification airworthiness criteria. Also, as previously discussed, FAA regulations do not require a QRH. Therefore, it would be inappropriate to require it to be readily available to the pilot at the control station.

Comment Summary: Droneport Texas LLC requested the FAA revise the airworthiness criteria to add required Flight Manual sections for routine maintenance and mission-specific equipment and procedures. The commenter stated that the remote pilot or personnel on the remote pilot-in-command's flight team accomplish most routine maintenance, and that the flight team usually does UA rigging with mission equipment.

FAA Response: The requested change is appropriate for a maintenance document rather than a flight manual because it addresses maintenance procedures rather than the piloting functions. The FAA also notes that, similar to the criteria for certain manned aircraft, the airworthiness criteria require that the applicant prepare instructions for continued airworthiness (ICA) in accordance with Appendix A to Part 23. As the applicant must provide any maintenance instructions and mission-specific information necessary for safe operation and continued operational safety of the UA, in accordance with D&R.205, no changes to the airworthiness criteria are necessary.

Comment Summary: An individual commenter requested the FAA revise the criteria in proposed UAS.200(b) to require that “other information” referred to in proposed UAS.200(a)(5) be approved by the FAA. The commenter noted that, as proposed, only the information listed in UAS.200(a)(1) through (4) must be FAA approved.

FAA Response: The change requested by the commenter would be inconsistent with the FAA's airworthiness standards for flight manuals for manned aircraft. Sections 23.2620(b), 25.1581(b), 27.1581(b), and 29.1581(b) include requirements for flight manuals to include operating limitations, operating procedures, performance information, loading information, and other information that is necessary safe operation because of design, operating, or handling characteristics, but limit FAA approval to operating limitations, operating procedures, performance information, and loading information.

Under § 23.2620(b)(1), for low-speed level 1 and level 2 airplanes, the FAA only approves the operating limitations. In applying a risk-based approach, the FAA has determined it would not be appropriate to hold the lowest risk UA to a higher standard than what is required for low speed level 1 and level 2 manned aircraft. Accordingly, the FAA has revised the airworthiness criteria to only require FAA approval of the operating limitations.

Comment Summary: NUAIR requested the FAA recognize that § 23.2620 is only applicable to the aircraft and does not address off-aircraft components such as the control station, control and non-payload communications (CNPC) data link, and launch and recovery equipment. The commenter noted that this is also true of industry consensus-based standards designed to comply with § 23.2620.

FAA Response: As explained in more detail in the Control Station section of this document, the FAA has revised the airworthiness criteria for the AE. The FAA will approve AE or minimum specifications for the AE that could affect airworthiness as an operating limitation in the UA flight manual. The FAA will establish the approved AE or minimum specifications as operating limitations and include them in the UA type certificate data sheet and Flight Manual in accordance with D&R.105(c). The establishment of requirements for, and the approval of AE will be in accordance with FAA Memorandum AIR600-21-AIR-600-PM01, dated July 13, 2021.

The FAA proposed durability and reliability testing that would require the applicant to demonstrate safe flight of the UAS across the entire operational envelope and up to all operational limitations, for all phases of flight and all aircraft configurations described in the applicant's CONOPS, with no failures that result in a loss of flight, loss of control, loss of containment, or emergency landing outside the operator's recovery area. The FAA further proposed that the unmanned aircraft would only be certificated for operations within the limitations, and for flight over areas no greater than the maximum population density, as described in the applicant's CONOPS and demonstrated by test.

Comment Summary: ALPA requested that the proposed certification criteria require all flights during testing be completed in both normal and non-normal or off-nominal scenarios with no failures that result in a loss of flight, loss of control, loss of containment, or emergency landing outside of the operator's recovery zone. Specifically, ALPA stated that testing must not require exceptional piloting skill or alertness and include, at a minimum: All phases of the flight envelope, including the highest UA to pilot ratios; the most adverse combinations of the conditions and configuration; the environmental conditions identified in the CONOPS; the different flight profiles and routes identified in the CONOPS; and exposure to EMI and HIRF.

FAA Response: No change is necessary because the introductory text and paragraphs (b)(7), (b)(9), (b)(10), (b)(13), (c), (d), (e), and (f) of D&R.300, which are adopted as proposed, contain the specific testing requirements requested by ALPA.

Comment Summary: Droneport Texas LLC requested the FAA revise the testing criteria to include, for operation at night, testing both with and without night vision aids. The commenter stated that because small UAS operation at night is waivable under 14 CFR part 107, manufacturers will likely make assumptions concerning a pilot's familiarity with night vision device-aided and unaided operations.

FAA Response: Under D&R.300(b)(11), the applicant must demonstrate by flight test that the UA can operate at night without failure using whatever equipment is onboard the UA itself. The pilot's familiarity, or lack thereof, with night vision equipment does not impact whether the UA is reliable and durable to complete testing without any failures.

Comment Summary: EASA requested the FAA clarify how testing durability and reliability commensurate to the maximum population density, as proposed, aligns with the Specific Operations Risk Assessment (SORA) approach that is open to operational mitigation, reducing the initial ground risk. An individual commenter requested the FAA provide more details about the correlation between the number of flight hours tested and the CONOPS environment ( e.g., population density). The commenter stated that this is one of the most fundamental requirements, and the FAA should ensure equal treatment to all current and future applicants.

FAA Response: In developing these testing criteria, the FAA sought to align the risk of UAS operations with the appropriate level of protection for human beings on the ground. The FAA proposed establishing the maximum population density demonstrated by durability and reliability testing as an operating limitation on the type certificate. However, the FAA has re-evaluated its approach and determined it to be more appropriate to connect the durability and reliability demonstrated during certification testing with the operating environment defined in the CONOPS.

Basing testing on maximum population density may result in limitations not commensurate with many actual operations. As population density broadly refers to the number of people living in a given area per square mile, it does not allow for evaluating variation in a local operating environment. For example, an operator may have a route in an urban environment with the actual flight path along a greenway; the number of human beings exposed to risk from the UA operating overhead would be significantly lower than the population density for the area. Conversely, an operator may have a route over an industrial area where few people live, but where, during business hours, there may be highly dense groups of people. Specific performance characteristics such as altitude and airspeed also factor into defining the boundaries for safe operation of the UA.

Accordingly, the FAA has revised D&R.300 to require the UA design to be durable and reliable when operated under the limitations prescribed for its operating environment. The information in the applicant's CONOPS will determine the operating environment for testing. For example, the minimum hours of reliability testing will be less for a UA conducting agricultural operations in a rural environment than if the same aircraft will be conducting package deliveries in an urban environment. The FAA will include the limitations that result from testing as operating limitations on the type certificate data sheet and in the UA Flight Manual. The FAA intends for this process to be similar to the process for establishing limitations prescribed for special purpose operations for restricted category aircraft. This allows for added flexibility in determining appropriate operating limitations, which will more closely reflect the operating environment.

Finally, a comparison of these criteria with EASA's SORA approach is beyond the scope of this document because the SORA is intended to result in an operational approval rather than a type certificate.

Comment Summary: EASA requested the FAA clarify how reliability at the aircraft level to ensure high-level safety objectives would enable validation of products under applicable bilateral agreements.

FAA Response: As the FAA and international aviation authorities are still developing general airworthiness standards for UA, it would be speculative for the FAA to comment on the validation process for any specific UA.

Comment Summary: EASA requested the FAA revise the testing criteria to include a compliance demonstration related to adverse combinations of the conditions and configurations and with respect to weather conditions and average pilot qualification.

FAA Response: No change is necessary because D&R.300(b)(7), (b)(9), (b)(10), (c), and (f), which are adopted as proposed, contain the specific testing requirements requested by EASA.

Comment Summary: EASA noted that, under the proposed criteria, testing involving a large number of flight hours will limit changes to the configuration.

FAA Response: Like manned aircraft, the requirements of 14 CFR part 21, subpart D, apply to UA for changes to type certificates. The FAA is developing procedures for processing type design changes for UA type certificated using durability and reliability testing.

Comment Summary: EASA requested the FAA clarify whether the proposed testing criteria would require the applicant to demonstrate aspects that do not occur during a successful flight, such as the deployment of emergency recovery systems and fire protection/post-crash fire. EASA asked if these aspects are addressed by other means and what would be the applicable airworthiness criteria.

FAA Response: Equipment not required for normal operation of the UA do not require an evaluation for their specific functionality. D&R testing will show that the inclusion of any such equipment does not prevent normal operation. Therefore, the airworthiness criteria would not require functional testing of the systems described by EASA.

Comment Summary: An individual commenter requested the FAA specify the acceptable percentage of failures in the testing that would result in a “loss of flight.” The Small UAV Coalition requested the FAA clarify what constitutes an emergency landing outside an operator's landing area, as some UAS designs could include an onboard health system that initiates a landing to lessen the potential of a loss of control event. The commenter suggested that, in those cases, a landing in a safe location should not invalidate the test.

FAA Response: The airworthiness criteria require that all test points and flight hours occur with no failures result in a loss of flight, control, containment, or emergency landing outside the operator's recovery zone. The FAA has determined that there is no acceptable percentage of failures in testing. In addition, while the recovery zone may differ for each UAS design, an emergency or unplanned landing outside of a designated landing area would result in a test failure.

Comment Summary: The Small UAV Coalition requested that a single failure during testing not automatically restart counting the number of flight test operations set for a particular population density; rather, the applicant should have the option to identify the failure through root-cause and fault-tree analysis and provide a validated mitigation to ensure it will not recur. An individual commenter requested the FAA to clarify whether the purpose of the tests is to show compliance with a quantitative safety objective. The commenter further requested the FAA allow the applicant to reduce the number of flight testing hours if the applicant can present a predicted safety and reliability analysis.

FAA Response: The intent of the testing criteria is for the applicant to demonstrate the aircraft's durability and reliability through a successful accumulation of flight testing hours. The FAA does not intend to require analytical evaluation to be part of this process. However, the applicant will comply with these testing criteria using a means of compliance, accepted by the FAA, through the issue paper process. The means of compliance will be dependent on the CONOPS the applicant has proposed to meet.

The FAA proposed criteria to evaluate how the UAS functions after probable failures, including failures related to propulsion systems, C2 link, GPS, critical flight control components with a single point of failure, control station, and any other equipment identified by the applicant.

Comment Summary: Droneport Texas LLC requested the FAA add a bird strike to the list of probable failures. The commenter stated that despite sense and avoid technologies, flocks of birds can overcome the maneuver capabilities of a UA and result in multiple, unintended failures.

FAA Response: Unlike manned aircraft, where aircraft size, design, and construct are critical to safe control of the aircraft after encountering a bird strike, the FAA determined testing for bird strike capabilities is not necessary for the Model TELEGRID DE2020 UA. The FAA has determined that a bird strike requirement is not necessary because the smaller size and lower operational speed of the TELEGRID DE2020 reduce the likelihood of a bird strike, combined with the reduced consequences of failure due to no persons onboard. Instead, the FAA is using a risk-based approach to tailor airworthiness requirements commensurate to the low-risk nature of the Model TELEGRID DE2020 UA.

Comment Summary: ALPA requested the FAA require that all probable failure tests occur at the critical phase and mode of flight and at the highest aircraft-to-pilot ratio. ALPA stated the proposed criteria are critically important for systems that rely on a single source to perform multi-label functions, such as GNSS, because failure or interruption of GNSS will lead to loss of positioning, navigation, and timing (PNT) and functions solely dependent on PNT, such as geo-fencing and contingency planning.

FAA Response: No change is necessary because D&R.300(c) requires that the testing occur at the critical phase and mode of flight and at the highest UA-to-pilot ratio.

Comment Summary: Droneport Texas LLC requested the FAA add recovery from vortex ring state (VRS) to the list of probable failures. The commenter stated the UA uses multiple rotors for lift and is therefore susceptible to VRS. The commenter further stated that because recovery from settling with power is beyond a pilot's average skill for purposes of airworthiness testing, the aircraft must be able to sense and recover from this condition without pilot assistance.

FAA Response: D&R.305 addresses probable failures related to specific components of the UAS. VRS is an aerodynamic condition a UA may encounter during flight testing; it is not a component subject to failure.

Comment Summary: Droneport Texas LLC also requested the FAA add a response to the Air Traffic Control-Zero (ATC-Zero) command to the list of probable failures. The commenter stated, based on lessons learned after the attacks on September 11, 2001, aircraft that can fly BVLOS should be able to respond to an ATC-Zero condition.

FAA Response: The commenter's request is more appropriate for the capabilities and functions testing criteria in D&R.310 than probable failures testing in D&R.305. D&R.310(a)(3) requires the applicant to demonstrate by test that the pilot has the ability to safely discontinue a flight. A pilot may discontinue a flight for a wide variety of reasons, including responding to an ATC-zero command.

Comment Summary: EASA stated the proposed language seems to require an additional analysis and safety assessment, which would be appropriate for the objective requirement of ensuring a probable failure does not result in a loss of containment or control. EASA further stated that an applicant's basic understanding of the systems architecture and effects of failures is essential.

FAA Response: The FAA agrees with the expectation that applicants understand the system architecture and effects of failures of a proposed design, which is why the criteria include a requirement for the applicant to test the specific equipment identified in D&R.305 and identify any other equipment that is not specifically identified in D&R.305 for testing. As the intent of the criteria is for the applicant to demonstrate compliance through testing, some analysis may be necessary to properly identify the appropriate equipment to be evaluated for probable failures.

Comment Summary: An individual requested that probable failure testing apply not only to critical flight control components with a single point of failure, but also to any critical part with a single point of failure.

FAA Response: The purpose of probable failure testing in D&R.305 is to demonstrate that if certain equipment fails, it will fail safely. Adding probable failure testing for critical (now flight essential) parts would not add value to testing. If a part is essential for flight, its failure by definition in D&R.135(a) could result in a loss of flight or unrecoverable loss of control. For example, on a traditional airplane design, failure of a wing spar in flight would lead to loss of the aircraft. Because there is no way to show that a wing spar can fail safely, the applicant must provide its mandatory replacement time if applicable, structural inspection interval, and related structural inspection procedure in the Airworthiness Limitations section of the ICA. Similarly, under these airworthiness criteria, parts whose failure would inherently result in loss of flight or unrecoverable loss of control are not subjected to probable failure testing. Instead, they must be identified as flight essential components and included in the ICA.

To avoid confusion pertaining to probable failure testing, the FAA has removed the word “critical” from D&R.305(a)(5). In the final airworthiness criteria, probable failure testing required by D&R.305(a)(5) applies to “Flight control components with a single point of failure.”

The FAA proposed criteria to require the applicant to demonstrate by test the minimum capabilities and functions necessary for the design. UAS.310(a) proposed to require the applicant to demonstrate, by test, the capability of the UAS to regain command and control of the UA after a C2 link loss, the sufficiency of the electrical system to carry all anticipated loads, and the ability of the pilot to override any pre-programming in order to resolve a potential unsafe operating condition in any phase of flight. UAS.310(b) proposed to require the applicant to demonstrate by test certain features if the applicant requests approval of those features (geo-fencing, external cargo, etc.). UAS.310(c) proposed to require the design of the UAS to safeguard against an unintended discontinuation of flight or release of cargo, whether by human action or malfunction.

Comment Summary: ALPA stated the pilot-in-command must always have the capability to input control changes to the UA and override any pre-programming without delay as needed for the safe management of the flight. The commenter requested that the FAA retain the proposed criteria that would allow the pilot to command to: Regain command and control of the UA after loss of the C2 link; safely discontinue the flight; and dynamically re-route the UA. In support, ALPA stated the ability of the pilot to continually command (re-route) the UA, including termination of the flight if necessary, is critical for safe operations and should always be available to the pilot.

Honeywell requested the FAA revise paragraphs (a)(3) and (a)(4) of the criteria (UAS.310) to allow for either the pilot or an augmenting system to safely discontinue the flight and re-route the UA. The commenter stated that a system comprised of detect and avoid, onboard autonomy, and ground system can be used for these functions. Therefore, the criteria should not require that only the pilot can do them.

An individual commenter requested the FAA remove UAS.310(a)(4) of the proposed criteria because requiring the ability for the pilot to dynamically re-route the UA is too prescriptive and redundant with the proposed requirement in UAS.310(a)(3), the ability of the pilot to discontinue the flight safely.

FAA Response: Because the pilot in command is directly responsible for the operation of the UA, the pilot must have the capability to command actions necessary for continued safety. This includes commanding a change to the flight path or, when appropriate, safely terminating a flight. The FAA notes that the ability for the pilot to safely discontinue a flight means the pilot has the means to terminate the flight and immediately and safely return the UA to the ground. This is different from the pilot having the means to dynamically re-route the UA, without terminating the flight, to avoid a conflict.

Therefore, the final airworthiness criteria include D&R.310(a) as proposed (UAS.310(a)).

Comment Summary: ALPA requested the FAA revise the criteria to require that all equipment, systems, and installations conform, at a minimum, to the standards of § 25.1309.

FAA Response: The FAA determined that traditional methodologies for manned aircraft, including the system safety analysis required by §§ 23.2510, 25.1309, 27.1309, or 29.1309, would be inappropriate to require for the TELEGRID Model TELEGRID DE2020 due to its smaller size and reduced level of complexity. Instead, the FAA finds that system reliability through testing will ensure the safety of this design.

Comment Summary: ALPA requested the FAA revise the criteria to add a requirement to demonstrate the ability of the UA and pilot to perform all of the contingency plans identified in proposed UAS.120.

FAA Response: No change is necessary because D&R.120 and D&R.305(a)(2), together, require what ALPA requests in its comment. Under D&R.120, the applicant must design the UA to execute a predetermined action in the event of a loss of the C2 link. D&R.305(a)(2) requires the applicant to demonstrate by test that a lost C2 link will not result in a loss of containment or control of the UA. Thus, if the applicant does not demonstrate the predetermined contingency plan resulting from a loss of the C2 link when conducting D&R.305 testing, the test would be a failure due to loss of containment.

Comment Summary: ALPA and an individual commenter requested the FAA revise the criteria so that geo-fencing is a required feature and not optional due to the safety concerns that could result from a UA exiting its operating area.

FAA Response: To ensure safe flight, the applicant must test the proposed safety functions, such as geo-fencing, that are part of the type design of the Model TELEGRID DE2020 UA. The FAA determined that geo-fencing is an optional feature because it is one way, but not the only way, to ensure a safely contained operation.

Comment Summary: ALPA requested the FAA revise the criteria so that capability to detect and avoid other aircraft and obstacles is a required feature and not optional.

FAA Response: D&R.310(a)(4) requires the applicant demonstrate the ability for the pilot to safely re-route the UA in flight to avoid a dynamic hazard. The FAA did not prescribe specific design features such as a collision avoidance system to meet D&R.310(a)(4) because there are multiple means to minimize the risk of collision.

Comment Summary: McMahon Helicopter Services requested that the airworthiness criteria require a demonstration of sense-and-avoid technology that will automatically steer the UA away from manned aircraft, regardless of whether the manned aircraft has a transponder. NAAA and an individual commenter requested that the FAA require ADS-B in/out and traffic avoidance software on all UAS. The Small UAV Coalition requested the FAA establish standards for collision avoidance technology, as the proposed criteria are not sufficient for compliance with the operational requirement to see and avoid other aircraft (§ 91.113). The commenters stated that these technologies are necessary to avoid a mid-air collision between UA and manned aircraft.

FAA Response: D&R.310(a)(4) requires the applicant demonstrate the ability for the UA to be safely re-routed in flight to avoid a dynamic hazard. The FAA did not prescribe specific design features, such as the technologies suggested by the commenters, to meet D&R.310(a)(4) because they are not the only means for complying with the operational requirement to see and avoid other aircraft. If an applicant chooses to equip their UA with onboard collision avoidance technology, those capabilities and functions must be demonstrated by test per D&R.310(b)(5).

The FAA proposed to require an evaluation of the UA's performance, maneuverability, stability, and control with a factor of safety.

Comment Summary: EASA requested that the FAA revise its approach to require a similar compliance demonstration as EASA's for “light UAS.” EASA stated the FAA's proposed criteria for verification of limits, combined with the proposed Flight Manual requirements, seem to replace a traditional Subpart Flight. 3 EASA further stated the FAA's approach in the proposed airworthiness criteria might necessitate more guidance and means of compliance than the traditional structure.

FAA Response: The FAA's airworthiness criteria will vary from EASA's light UAS certification requirements, resulting in associated differences in compliance demonstrations. At this time, comment on means of compliance and related guidance material, which are still under development with the FAA and with EASA, would be speculative.

Comment Summary: ALPA requested the FAA conduct an analysis to determine battery reliability and safety, taking into account wind and weather conditions and their effect on battery life. ALPA expressed concern with batteries as the only source of power for an aircraft in the NAS. ALPA further requested the FAA not grant exemptions for battery reserve requirements.

FAA Response: Because batteries are a flight essential part, the applicant must establish mandatory instructions or life limits for batteries under the requirements of D&R.135. In addition, when the applicant conducts its D&R testing, D&R.300(i) prevents the applicant from exceeding the maintenance intervals or life limits for those batteries. To the extent the commenter's request addresses fuel reserves, that is an operational requirement, not a certification requirement, and therefore beyond the scope of this document.

Comment Summary: McMahon Helicopter Services requested that the criteria require anti-collision and navigation lighting certified to existing FAA standards for brightness and size. The commenter stated that these standards were based on human factors for nighttime and daytime recognition and are not simply a lighting requirement. An individual commenter requested that the criteria include a requirement for position lighting and anti-collision beacons meeting TSO-30c Level III. NAAA requested the criteria require a strobe light and high visibility paint scheme to aid in visual detection of the UA by other aircraft.

FAA Response: The FAA determined it is unnecessary for these airworthiness criteria to prescribe specific design features for anti-collision or navigation lighting. The FAA will address anti-collision lighting as part of any operational approval, similar to the rules in 14 CFR 107.29(a)(2) and (b) for small UAS.

Comment Summary: ALPA requested the FAA add a new section with minimum standards for Global Navigation Satellite System (GNSS), as the UAS will likely rely heavily upon GNSS for navigation and to ensure that the UA does not stray outside of its approved airspace. ALPA stated that technological advances have made such devices available at an appropriate size, weight, and power for UAs.

FAA Response: The airworthiness criteria in D&R.100 (UA Signal Monitoring and Transmission), D&R.110 (Software), D&R.115 (Cybersecurity), and D&R.305(a)(3) (probable failures related to GPS) sufficiently address design requirements and testing of navigation systems. Even if the applicant uses a TSO-approved GNSS, these airworthiness criteria require a demonstration that the UA operates successfully without loss of containment. Successful completion of these tests demonstrates that the navigation subsystems are acceptable.

Comment Summary: ALPA requested the FAA revise the criteria to add a new section requiring equipage to comply with the FAA's new rules on Remote Identification of Unmanned Aircraft (86 FR 4390, Jan. 15, 2021). An individual commenter questioned the need for public tracking and identification of drones in the event of a crash or violation of FAA flight rules.

FAA Response: The FAA issued the final rule, Remote Identification of Unmanned Aircraft, after providing an opportunity for public notice and comment. The final rule is codified at 14 CFR part 89. Part 89 contains the remote identification requirements for unmanned aircraft certificated and produced under part 21 after September 16, 2022.

Comment Summary: ALPA, NAAA, and one individual questioned the safety of multiple Model TELEGRID DE2020 UA operated by a single pilot, up to a ratio of 20 UA to 1 pilot. ALPA stated that even with high levels of automation, the pilot must still manage the safe operation and maintain situational awareness of multiple aircraft in their flight path, aircraft systems, integration with traffic, obstacles, and other hazards during normal, abnormal, and emergency conditions. As a result, ALPA recommended the FAA conduct additional studies to better understand the feasibility of a single pilot operating multiple UA before developing airworthiness criteria. The Small UAV Coalition requested the FAA provide criteria for an aircraft-to-pilot ratio higher than 20:1.

FAA Response: These airworthiness criteria are specific to the Model TELEGRID DE2020 UA and, as discussed previously in this preamble, operations of the Model TELEGRID DE2020 UA may include multiple UA operated by a single pilot, up to a ratio of 20 UA to 1 pilot. Additionally, these airworthiness criteria require the applicant to demonstrate the durability and reliability of the UA design by flight test, at the highest aircraft-to-pilot ratio, without exceptional piloting skill or alertness. In addition, D&R.305(c) requires the applicant to demonstrate probable failures by test at the highest aircraft-to-pilot ratio. Should the pilot ratio cause a loss of containment or control of the UA, then the applicant will fail this testing.

Comment Summary: ALPA stated that to allow a UAS-pilot ratio of up to 20:1 safely, the possibility that the pilot will need to intervene with multiple UA simultaneously must be “extremely remote.” ALPA questioned whether this is feasible given the threat of GNSS interference or unanticipated wind gusts exceeding operational limits.

FAA Response: The FAA's guidance in AC 23.1309-1E, System Safety Analysis and Assessment for Part 23 Airplanes defines “extremely remote failure conditions” as failure conditions not anticipated to occur during the total life of an airplane, but which may occur a few times when considering the total operational life of all airplanes of the same type. When assessing the likelihood of a pilot needing to intervene with multiple UA simultaneously, the minimum reliability requirements will be determined based on the applicant's proposed CONOPS.

Comment Summary: An individual commenter expressed concern about noise pollution.

FAA Response: The Model TELEGRID DE2020 will need to comply with FAA noise certification standards. If the FAA determines that 14 CFR part 36 does not contain adequate standards for this design, the agency will propose and seek public comment on a rule of particular applicability for noise requirements under a separate rulemaking docket.

Comment Summary: ALPA, McMahon Helicopter Services, and NAAA commented on the operation of UAS at or below 400 feet AGL. ALPA, McMahon Helicopter Services, and NAAA requested the airworthiness criteria contain measures for safe operation at low altitudes so that UAS are not a hazard to manned aircraft, especially operations involving helicopters; air tours; agricultural applications; emergency medical services; air tanker firefighting; power line and pipeline patrol and maintenance; fish and wildlife service; animal control; military and law enforcement; seismic operations; ranching and livestock relocation; and mapping.

FAA Response: The type certificate only establishes the approved design of the UA. These airworthiness criteria require the applicant show compliance for the UA altitude sought for type certification. While this may result in operating limitations in the flight manual, the type certificate is not an approval for operations. Operations and operational requirements are beyond the scope of this document.

Comment Summary: NUAIR requested the FAA complete and publish its draft AC 21.17-XX, Type Certification Basis for Unmanned Aircraft Systems (UAS), to provide additional guidance, including templates, to those who seek a type design approval for UAS. NUAIR also requested the FAA recognize the industry consensus-based standards applicable to UAS, as Transport Canada has by publishing its AC 922-001, Remotely Piloted Aircraft Systems Safety Assurance.

FAA Response: The FAA will continue to develop policy and guidance for UA type certification and will publish guidance as soon as practicable. The FAA encourages consensus standards bodies to develop means of compliance and submit them to the FAA for acceptance. Regarding Transport Canada AC 922-001, that AC addresses operational approval rather than type certification.

Comment Summary: ALPA requested the FAA ensure that operations, including UA integrity, fall under the safety management system. ALPA further requested the FAA convene a Safety Risk Management Panel before allowing operators to commence operations and that the FAA require operators to have an active safety management system, including a non-punitive safety culture, where incident and continuing airworthiness issues can be reported.

FAA Response: The type certificate only establishes the approved design of the UA, including the Flight Manual and ICA. Operations and operational requirements, including safety management and oversight of operations and maintenance, are beyond the scope of this document.

Comment Summary: ALPA supported the FAA's type certification of UAS as a “special class” of aircraft under § 21.17(b) but requested that it be temporary.

FAA Response: As the FAA stated in its notice of policy issued August 11, 2020 (85 FR 58251, September 18, 2020), the FAA will use the type certification process under § 21.17(b) for some unmanned aircraft with no occupants onboard. The FAA further stated in its policy that it may also issue type certificates under § 21.17(a) for airplane and rotorcraft UAS designs where the airworthiness standards in part 23, 25, 27, or 29, respectively, are appropriate. The FAA, in the future, may consider establishing appropriate generally applicable airworthiness standards for UA that are not certificated under the existing standards in parts 23, 25, 27, or 29.

The FAA received and reviewed several comments that were general, stated the commenter's viewpoint or opposition without a suggestion specific to the proposed criteria, or did not make a request the FAA can act on. These comments are beyond the scope of this document.

These airworthiness criteria, established under the provisions of § 21.17(b), are applicable to the TELEGRID Model TELEGRID DE2020 UA. Should TELEGRID wish to apply these airworthiness criteria to other UA models, it must submit a new type certification application.

This action affects only certain airworthiness criteria for the TELEGRID Model TELEGRID DE2020 UA. It is not a standard of general applicability.

The authority citation for these airworthiness criteria is as follows:

Pursuant to the authority delegated to me by the Administrator, the following airworthiness criteria are issued as part of the type certification basis for the TELEGRID Model TELEGRID DE2020 unmanned aircraft. The FAA finds that compliance with these criteria appropriately mitigates the risks associated with the design and concept of operations and provides an equivalent level of safety to existing rules.

The applicant must define and submit to the FAA a concept of operations (CONOPS) proposal describing the unmanned aircraft system (UAS) operation in the national airspace system for which unmanned aircraft (UA) type certification is requested. The CONOPS proposal must include, at a minimum, a description of the following information in sufficient detail to determine the parameters and extent of testing and operating limitations:

(a) The intended type of operations;

(b) UA specifications;

(c) Meteorological conditions;

(d) Operators, pilots, and personnel responsibilities;

(e) Control station, support equipment, and other associated elements (AE) necessary to meet the airworthiness criteria;

(f) Command, control, and communication functions;

(g) Operational parameters (such as population density, geographic operating boundaries, airspace classes, launch and recovery area, congestion of proposed operating area, communications with air traffic control, line of sight, and aircraft separation); and

(h) Collision avoidance equipment, whether onboard the UA or part of the AE, if requested.

For purposes of these airworthiness criteria, the following definitions apply.

(a) Loss of Control: Loss of control means an unintended departure of an aircraft from controlled flight. It includes control reversal or an undue loss of longitudinal, lateral, and directional stability and control. It also includes an upset or entry into an unscheduled or uncommanded attitude with high potential for uncontrolled impact with terrain. A loss of control means a spin, loss of control authority, loss of aerodynamic stability, divergent flight characteristics, or similar occurrence, which could generally lead to crash.

(b) Loss of Flight: Loss of flight means a UA's inability to complete its flight as planned, up to and through its originally planned landing. It includes scenarios where the UA experiences controlled flight into terrain, obstacles, or any other collision, or a loss of altitude that is severe or non-reversible. Loss of flight also includes deploying a parachute or ballistic recovery system that leads to an unplanned landing outside the operator's designated recovery zone.

The UA must be designed to monitor and transmit to the AE all information required for continued safe flight and operation. This information includes, at a minimum, the following:

(a) Status of all critical parameters for all energy storage systems;

(b) Status of all critical parameters for all propulsion systems;

(c) Flight and navigation information as appropriate, such as airspeed, heading, altitude, and location; and

(d) Communication and navigation signal strength and quality, including contingency information or status.

(a) The applicant must identify and submit to the FAA all AE and interface conditions of the UAS that affect the airworthiness of the UA or are otherwise necessary for the UA to meet these airworthiness criteria. As part of this requirement—

(1) The applicant may identify either specific AE or minimum specifications for the AE.

(i) If minimum specifications are identified, they must include the critical requirements of the AE, including performance, compatibility, function, reliability, interface, pilot alerting, and environmental requirements.

(ii) Critical requirements are those that if not met would impact the ability to operate the UA safely and efficiently.

(2) The applicant may use an interface control drawing, a requirements document, or other reference, titled so that it is clearly designated as AE interfaces to the UA.

(b) The applicant must show the FAA the AE or minimum specifications identified in paragraph (a) of this section meet the following:

(1) The AE provide the functionality, performance, reliability, and information to assure UA airworthiness in conjunction with the rest of the design;

(2) The AE are compatible with the UA capabilities and interfaces;

(3) The AE must monitor and transmit to the pilot all information required for safe flight and operation, including but not limited to those identified in D&R.100; and

(4) The minimum specifications, if identified, are correct, complete, consistent, and verifiable to assure UA airworthiness.

(c) The FAA will establish the approved AE or minimum specifications as operating limitations and include them in the UA type certificate data sheet and Flight Manual.

(d) The applicant must develop any maintenance instructions necessary to address implications from the AE on the airworthiness of the UA. Those instructions will be included in the instructions for continued airworthiness (ICA) required by D&R.205.

To minimize the existence of software errors, the applicant must:

(a) Verify by test all software that may impact the safe operation of the UA;

(b) Utilize a configuration management system that tracks, controls, and preserves changes made to software throughout the entire life cycle; and

(c) Implement a problem reporting system that captures and records defects and modifications to the software.

(a) UA equipment, systems, and networks, addressed separately and in relation to other systems, must be protected from intentional unauthorized electronic interactions that may result in an adverse effect on the security or airworthiness of the UA. Protection must be ensured by showing that the security risks have been identified, assessed, and mitigated as necessary.

(b) When required by paragraph (a) of this section, procedures and instructions to ensure security protections are maintained must be included in the ICA.

(a) The UA must be designed so that, in the event of a loss of the command and control (C2) link, the UA will automatically and immediately execute a safe predetermined flight, loiter, landing, or termination.

(b) The applicant must establish the predetermined action in the event of a loss of the C2 link and include it in the UA Flight Manual.

(c) The UA Flight Manual must include the minimum performance requirements for the C2 data link defining when the C2 link is degraded to a level where remote active control of the UA is no longer ensured. Takeoff when the C2 link is degraded below the minimum link performance requirements must be prevented by design or prohibited by an operating limitation in the UA Flight Manual.

(a) Except as provided in paragraph (b) of this section, the UA must have design characteristics that will protect the UA from loss of flight or loss of control due to lightning.

(b) If the UA has not been shown to protect against lightning, the UA Flight Manual must include an operating limitation to prohibit flight into weather conditions conducive to lightning activity.

(a) For purposes of this section, “adverse weather conditions” means rain, snow, and icing.

(b) Except as provided in paragraph (c) of this section, the UA must have design characteristics that will allow the UA to operate within the adverse weather conditions specified in the CONOPS without loss of flight or loss of control.

(c) For adverse weather conditions for which the UA is not approved to operate, the applicant must develop operating limitations to prohibit flight into known adverse weather conditions and either:

(1) Develop operating limitations to prevent inadvertent flight into adverse weather conditions; or

(2) Provide a means to detect any adverse weather conditions for which the UA is not certificated to operate and show the UA's ability to avoid or exit those conditions.

(a) A flight essential part is a part, the failure of which could result in a loss of flight or unrecoverable loss of UA control.

(b) If the type design includes flight essential parts, the applicant must establish a flight essential parts list. The applicant must develop and define mandatory maintenance instructions or life limits, or a combination of both, to prevent failures of flight essential parts. Each of these mandatory actions must be included in the Airworthiness Limitations Section of the ICA.

The applicant must provide a Flight Manual with each UA.

(a) The UA Flight Manual must contain the following information:

(1) UA operating limitations;

(2) UA operating procedures;

(3) Performance information;

(4) Loading information; and

(5) Other information that is necessary for safe operation because of design, operating, or handling characteristics.

(b) Those portions of the UA Flight Manual containing the information specified in paragraph (a)(1) of this section must be approved by the FAA.

The applicant must prepare ICA for the UA in accordance with Appendix A to Part 23, as appropriate, that are acceptable to the FAA. The ICA may be incomplete at type certification if a program exists to ensure their completion prior to delivery of the first UA or issuance of a standard airworthiness certificate, whichever occurs later.

The UA must be designed to be durable and reliable when operated under the limitations prescribed for its operating environment, as documented in its CONOPS and included as operating limitations on the type certificate data sheet and in the UA Flight Manual. The durability and reliability must be demonstrated by flight test in accordance with the requirements of this section and completed with no failures that result in a loss of flight, loss of control, loss of containment, or emergency landing outside the operator's recovery area.

(a) Once a UA has begun testing to show compliance with this section, all flights for that UA must be included in the flight test report.

(b) Tests must include an evaluation of the entire flight envelope across all phases of operation and must address, at a minimum, the following:

(1) Flight distances;

(2) Flight durations;

(3) Route complexity;

(4) Weight;

(5) Center of gravity;

(6) Density altitude;

(7) Outside air temperature;

(8) Airspeed;

(9) Wind;

(10) Weather;

(11) Operation at night, if requested;

(12) Energy storage system capacity; and

(13) Aircraft to pilot ratio.

(c) Tests must include the most adverse combinations of the conditions and configurations in paragraph (b) of this section.

(d) Tests must show a distribution of the different flight profiles and routes representative of the type of operations identified in the CONOPS.

(e) Tests must be conducted in conditions consistent with the expected environmental conditions identified in the CONOPS, including electromagnetic interference (EMI) and high intensity radiated fields (HIRF).

(f) Tests must not require exceptional piloting skill or alertness.

(g) Any UAS used for testing must be subject to the same worst-case ground handling, shipping, and transportation loads as those allowed in service.

(h) Any UA used for testing must use AE that meet, but do not exceed, the minimum specifications identified under D&R.105. If multiple AE are identified, the applicant must demonstrate each configuration.

(i) Any UAS used for testing must be maintained and operated in accordance with the ICA and UA Flight Manual. No maintenance beyond the intervals established in the ICA will be allowed to show compliance with this section.

(j) If cargo operations or external-load operations are requested, tests must show, throughout the flight envelope and with the cargo or external-load at the most critical combinations of weight and center of gravity, that—

(1) The UA is safely controllable and maneuverable; and

(2) The cargo or external-load are retainable and transportable.

The UA must be designed such that a probable failure will not result in a loss of containment or control of the UA. This must be demonstrated by test.

(a) Probable failures related to the following equipment, at a minimum, must be addressed:

(1) Propulsion systems;

(2) C2 link;

(3) Global Positioning System (GPS);

(4) Flight control components with a single point of failure;

(5) Control station; and

(6) Any other AE identified by the applicant.

(b) Any UA used for testing must be operated in accordance with the UA Flight Manual.

(c) Each test must occur at the critical phase and mode of flight, and at the highest aircraft-to-pilot ratio.

(a) All of the following required UAS capabilities and functions must be demonstrated by test:

(1) Capability to regain command and control of the UA after the C2 link has been lost.

(2) Capability of the electrical system to power all UA systems and payloads.

(3) Ability for the pilot to safely discontinue the flight.

(4) Ability for the pilot to dynamically re-route the UA.

(5) Ability to safely abort a takeoff.

(6) Ability to safely abort a landing and initiate a go-around.

(b) The following UAS capabilities and functions, if requested for approval, must be demonstrated by test:

(1) Continued flight after degradation of the propulsion system.

(2) Geo-fencing that contains the UA within a designated area, in all operating conditions.

(3) Positive transfer of the UA between control stations that ensures only one control station can control the UA at a time.

(4) Capability to release an external cargo load to prevent loss of control of the UA.

(5) Capability to detect and avoid other aircraft and obstacles.

(c) The UA must be designed to safeguard against inadvertent discontinuation of the flight and inadvertent release of cargo or external load.

The structure of the UA must be shown to withstand the repeated loads expected during its service life without failure. A life limit for the airframe must be established, demonstrated by test, and included in the ICA.

The performance, maneuverability, stability, and control of the UA within the flight envelope described in the UA Flight Manual must be demonstrated at a minimum of 5% over maximum gross weight with no loss of control or loss of flight.

3DRobotics Government Services (3DR) applied to the FAA on May 1, 2019, for a special class type certificate under Title 14, Code of Federal Regulations (14 CFR) 21.17(b) for the Model 3DR-GS H520-G unmanned aircraft system (UAS).

The Model 3DR-GS H520-G consists of a rotorcraft UA and its associated elements (AE) including communication links and components that control the UA. The Model 3DR-GS H520-G UA has a maximum gross takeoff weight of five pounds. It is approximately 20 inches in width, 18 inches in length, and 12 inches in height. The Model 3DR-GS H520-G UA uses battery-powered electric motors for vertical takeoff, landing, and forward flight. The UA may be manually operated or may rely on high levels of automation. The UAS may include multiple UA operated by a single pilot, up to a ratio of 20 UA to 1 pilot. 3DR anticipates operators will use the Model 3DR-GS H520-G for inspection or surveying of critical infrastructure. The proposed concept of operations (CONOPS) for the Model 3DR-GS H520-G identifies a maximum operating altitude of 400 feet above ground level (AGL), a maximum cruise speed of 33 knots (38 mph), operations within visual line of sight of the pilot, operations at night, and operations in sparsely populated areas. 3DR has not requested type certification for flight into known icing for the Model 3DR-GS H520-G.

The FAA issued a notice of proposed airworthiness criteria for the 3DR-GS H520-G UAS, which published in the Federal Register on November 24, 2020 (85 FR 74926).

Based on the comments received, these final airworthiness criteria reflect the following changes, as explained in more detail under Discussion of Comments: A new section containing definitions; revisions to the CONOPS requirement; changing the term “critical part” to “flight essential part” in D&R.135; changing the basis of the durability and reliability testing from population density to limitations prescribed for the operating environment identified in the applicant's CONOPS per D&R.001; and, for the demonstration of certain required capabilities and functions as required by D&R.310.

Additionally, the FAA re-evaluated its approach to type certification of low-risk UA using durability and reliability testing. Safe UAS operations depend and rely on both the UA and the AE. As explained in FAA Memorandum AIR600-21-AIR-600-PM01, dated July 13, 2021, the FAA has revised the airworthiness criteria to define a boundary between the UA type certification and subsequent operational evaluations and approval processes for the UAS ( i.e., waivers, exemptions, and/or operating certificates).

To reflect that these airworthiness criteria rely on durability and reliability (D&R) testing for certification, the FAA changed the prefix of each section from “UAS” to “D&R.”

Lastly, the FAA revised D&R.001(g) to clarify that the operational parameters listed in that paragraph are examples and not an all-inclusive list.

The FAA received responses from 15 commenters. The majority of the commenters were individuals. In addition to the individuals' comments, the FAA also received comments from the European Union Aviation Safety Agency (EASA), unmanned aircraft manufacturers, a helicopter operator, and organizations such as the Air Line Pilots Association (ALPA), Droneport Texas, LLC, Northeast UAS Airspace Integration Research Alliance, Inc. (NUAIR), and the Small UAV Coalition.

Comment Summary: ALPA, NUAIR, and the Small UAV Coalition expressed support for type certification as a special class of aircraft and establishing airworthiness criteria under § 21.17(b). The Small UAV Coalition also supported the FAA's proposed use of performance-based standards.

Comment Summary: An individual commenter requested the FAA define the term “loss of flight” and clarify how it is different from “loss of control.” The commenter questioned whether loss of flight meant the UA could not continue its intended flight plan but could safely land or terminate the flight.

FAA Response: The FAA has added a new section, D&R.005, to define the terms “loss of flight” and “loss of control” for the purposes of these airworthiness criteria. “Loss of flight” refers to a UA's inability to complete its flight as planned, up to and through its originally planned landing. “Loss of flight” includes scenarios where the UA experiences controlled flight into terrain or obstacles, or any other collision, or a loss of altitude that is severe or non-recoverable. “Loss of flight” includes deploying a parachute or ballistic recovery system that leads to an unplanned landing outside the operator's designated recovery zone.

“Loss of control” means an unintended departure of an aircraft from controlled flight. It includes control reversal or an undue loss of longitudinal, lateral, and directional stability and control. It also includes an upset or entry into an unscheduled or uncommanded attitude with high potential for uncontrolled impact with terrain. “Loss of control” means a spin, loss of control authority, loss of aerodynamic stability, divergent flight characteristic, or similar occurrence, which could generally lead to a crash.

Comment Summary: Two commenters requested the FAA clarify terminology with respect to piloting skill and alertness. Droneport Texas LLC stated that the average pilot skill and alertness is currently undefined, as remote pilots do not undergo oral or practical examinations to obtain certification. NUAIR noted that, despite the definition of “exceptional piloting skill and alertness” in Advisory Circular (AC) 23-8C, Flight Test Guide for Certification of Part 23 Airplanes, there is a significant difference between the average skill and alertness of a remote pilot certified under 14 CFR part 107 and a pilot certified under 14 CFR part 61. The commenter requested the FAA clarify the minimum qualifications and ratings to perform as a remote pilot of a UAS with a type certificate.

FAA Response: These airworthiness criteria do not require exceptional piloting skill and alertness for testing. The FAA included this as a requirement to ensure the applicant passes testing by using pilots of average skill who have been certificated under part 61, as opposed to highly trained pilots with thousands of hours of flight experience.

The FAA proposed a requirement for the applicant to submit a CONOPS describing the UAS and identifying the intended operational concepts. The FAA explained in the preamble of the notice of proposed airworthiness criteria that the information in the CONOPS would determine parameters for testing and flight manual operating limitations.

Comment Summary: One commenter stated that the airworthiness criteria are generic and requested the FAA add language to proposed UAS.001 to clarify that some of the criteria may not be relevant or necessary.

FAA Response: Including the language requested by the commenter would be inappropriate, as these airworthiness criteria are project-specific. Thus, in this case, each element of these airworthiness criteria is a requirement specific to the type certification of 3DR's proposed UA design.

Comment Summary: ALPA requested the criteria specify that the applicant's CONOPS contain sufficient detail to determine the parameters and extent of testing, as well as operating limitations placed on the UAS for its operational uses.

FAA Response: The FAA agrees and has updated D&R.001 to clarify that the information required for inclusion in the CONOPS proposal (D&R.001(a) through (g)) must be described in sufficient detail to determine the parameters and extent of testing and operating limitations.

Comment Summary: ALPA requested the CONOPS include a description of a means to ensure separation from other aircraft and perform collision avoidance maneuvers. ALPA stated that its requested addition to the CONOPS is critical to the safety of other airspace users, as manned aircraft do not easily see most UAs.

FAA Response: The FAA agrees and has updated D&R.001 to require that the applicant identify collision avoidance equipment (whether onboard the UA or part of the AE), if the applicant requests to include that equipment.

Comment Summary: ALPA requested the FAA add security-related (other than cyber-security) requirements to the CONOPS criteria, including mandatory reporting of security occurrences, security training and awareness programs for all personnel involved in UAS operations, and security standards for the transportation of goods, similar to those for manned aviation.

FAA Response: The type certificate only establishes the approved design of the UA. Operations and operational requirements, including those regarding security occurrences, security training, and package delivery security standards (other than cybersecurity airworthiness design requirements) are beyond the scope of the airworthiness criteria established by this document and are not required for type certification.

Comment Summary: UAS.001(c) proposed to require that the applicant's CONOPS include a description of meteorological conditions. ALPA requested the FAA change UAS.001(c) to require a description of meteorological and environmental conditions and their operational limits. ALPA stated the CONOPS should include maximum wind speeds, maximum or minimum temperatures, maximum density altitudes, and other relevant phenomena that will limit operations or cause operations to terminate.

FAA Response: D&R.001(c) and D&R.125 address meteorological conditions, while D&R.001(g) addresses environmental considerations. The FAA determined that these criteria are sufficient to cover the weather phenomena mentioned by the commenter without specifically requiring identification of related operational limits.

To address the risks associated with loss of control of the UA, the FAA proposed that the applicant design the control station to provide the pilot with all information necessary for continued safe flight and operation.

Comment Summary: ALPA and one individual commenter requested the FAA revise the proposed criteria to add requirements for the control station. Specifically, these commenters requested the FAA include the display of data and alert conditions to the pilot, physical security requirements for both the control station and the UAS storage area, design requirements that minimize negative impact of extended periods of low pilot workload, transfer of control between pilots, and human factors/human machine interface considerations for handheld controls. NUAIR requested the FAA designate the control station as a flight critical component for operations.

EASA and an individual commenter requested the FAA consider flexibility in some of the proposed criteria. EASA stated that the list of information in proposed UAS.100 is too prescriptive and contains information that may not be relevant for highly automated systems. The individual commenter requested that the FAA allow part-time or non-continuous displays of required information that do not influence the safety of the flight.

FAA Response: Although the scope of the proposed airworthiness criteria applied to the entire UAS, the FAA has re-evaluated its approach to type certification of low-risk unmanned aircraft using durability and reliability testing. A UA is an aircraft that is operated without the possibility of direct human intervention from within or on the aircraft. 1 A UAS is defined as a UA and its AE, including communication links and the components that control the UA, that are required to operate the UAS safely and efficiently in the national airspace system. 2 As explained in FAA Memorandum AIR600-21-AIR-600-PM01, dated July 13, 2021, the FAA determined it will apply the regulations for type design approval, production approval, conformity, certificates of airworthiness, and maintenance to only the UA and not to the AE. However, because safe UAS operations depend and rely on both the UA and the AE, the FAA will consider the AE in assessing whether the UA meets the airworthiness criteria that comprise the certification basis.

While the AE items themselves will be outside the scope of the UA type design, the applicant will provide sufficient specifications for any aspect of the AE, including the control station, which could affect airworthiness. The FAA will approve either the specific AE or minimum specifications for the AE, as identified by the applicant, as part of the type certificate by including them as an operating limitation in the type certificate data sheet and flight manual. The FAA may impose additional operating limitations specific to the AE through conditions and limitations for inclusion in the operational approval ( i.e., waivers, exemptions, or a combination of these). In accordance with this approach, the FAA will consider the entirety of the UAS for operational approval and oversight.

Accordingly, the FAA has revised the criteria by replacing proposed section UAS.100, applicable to the control station design, with D&R.100, UA Signal Monitoring and Transmission, with substantively similar criteria that apply to the UA design.

The FAA has also added a new section, D&R.105, UAS AE Required for Safe UA Operations, which requires the applicant to provide information concerning the specifications of the AE. The FAA has moved the alert function requirement proposed in UAS.100(a) to new section D&R.105(a)(1)(i). As part of the clarification of the testing of the interaction between the UA and AE, the FAA has added a requirement to D&R.300(h) for D&R testing to use minimum specification AE. This addition requires the applicant to demonstrate that the limits proposed for those AE will allow the UA to operate as expected throughout its service life. Finally, the FAA has revised references throughout the airworthiness criteria from “UAS” to “UA,” as appropriate, to reflect the FAA determination that the regulations for type design approval, production approval, conformity, certificates of airworthiness, and maintenance apply to only the UA.

The FAA proposed criteria on verification, configuration management, and problem reporting to minimize the existence of errors associated with UAS software.

Comment Summary: ALPA requested the FAA add language to the proposed criteria to ensure that some level of software engineering principles are used without being too prescriptive.

FAA Response: By combining the software testing requirement of D&R.110(a) with successful completion of the requirements in the entire “Testing” subpart, the acceptable level of software assurance will be identified and demonstrated. The configuration management system required by D&R.110(b) will ensure that the software is adequately documented and traceable both during and after the initial type certification activities.

Comment Summary: EASA suggested the criteria require that the applicant establish and correctly implement system requirements or a structured software development process for critical software.

FAA Response: Direct and specific evaluation of the software development process is more detailed than what the FAA intended with the proposed criteria, which use D&R testing to evaluate the UAS as a whole system, rather than evaluating individual components within the UA. Successful completion of the testing requirements provides confidence that the components that make up the UA provide an acceptable level of safety, commensurate to the low-risk nature of this aircraft. The FAA finds no change to the airworthiness criteria is needed.

Comment Summary: Two individual commenters requested the FAA require the manned aircraft software certification methodology in RTCA DO-178C, Software Considerations in Airborne Systems and Equipment Certification, for critical UA software.

FAA Response: Under these airworthiness criteria, only software that may affect the safe operation of the UA must be verified by test. To verify by test, the applicant will need to provide an assessment showing that other software is not subject to testing because it has no impact on the safe operation of the UA. For software that is subject to testing, the FAA may accept multiple options for software qualification, including DO-178C. Further, specifying that applicants must comply with DO-178 would be inconsistent with the FAA's intent to issue performance-based airworthiness criteria.

Because the UA requires a continuous wireless connection, the FAA proposed criteria to address the risks to the UAS from cybersecurity threats.

Comment Summary: ALPA requested adding a requirement for cybersecurity protection for navigation and position reporting systems such as Global Navigation Satellite System (GNSS). ALPA further requested the FAA include criteria to address specific cybersecurity vulnerabilities, such as jamming (denial of signal) and spoofing (false position data is inserted). ALPA stated that, for navigation, UAS primarily use GNSS—an unencrypted, open-source, low power transmission that can be jammed, spoofed, or otherwise manipulated.

FAA Response: The FAA will assess elements directly influencing the UA for cybersecurity under D&R.115 and will assess the AE as part of any operational approvals an operator may seek. D&R.115 (proposed as UAS.115) addresses intentional unauthorized electronic interactions, which includes, but is not limited to, hacking, jamming, and spoofing. These airworthiness criteria require the high-level outcome the UA must meet, rather than discretely identifying every aspect of cybersecurity the applicant will address.

The FAA proposed criteria requiring that the UAS be designed to automatically execute a predetermined action in the event of a loss of communication between the pilot and the UA. The FAA further proposed that the predetermined action be identified in the Flight Manual and that the UA be precluded from taking off when the quality of service is inadequate.

Comment Summary: ALPA requested the criteria encompass more than loss or degradation of the command and control (C2) link, as numerous types of critical part or systems failures can occur that include degraded capabilities, whether intermittent or sustained. ALPA requested the FAA add language to the proposed criteria to address specific failures such as loss of a primary navigation sensor, degradation or loss of navigation capability, and simultaneous impact of C2 and navigation links.

FAA Response: The airworthiness criteria address the issues raised by ALPA. Specifically, D&R.120(a) addresses actions the UA will automatically and immediately take when the operator no longer has control of the UA. Should the specific failures identified by ALPA result in the operator's loss of control, then the criteria require the UA to execute a predetermined action. Degraded navigation performance does not raise the same level of concern as a degraded or lost C2 link. For example, a UA may experience interference with a GPS signal on the ground, but then find acceptable signal strength when above a tree line or other obstruction. The airworthiness criteria require that neither degradation nor complete loss of GPS or C2, as either condition would be a failure of that system, result in unsafe loss of control or containment. The applicant must demonstrate this by test to meet the requirements of D&R.305(a)(3).

Under the airworthiness criteria, the minimum performance requirements for the C2 link, defining when the link is degraded to an unacceptable level, may vary among different UAS designs. The level of degradation that triggers a loss is dependent upon the specific UA characteristics; this level will be defined by the applicant and demonstrated to be acceptable by testing as required by D&R.305(a)(2) and D&R.310(a)(1).

Comment Summary: An individual commenter requested the FAA use distinct terminology for “communication,” used for communications with air traffic control, and “C2 link,” used for command and control between the remote pilot station and UA. The commenter questioned whether, in the proposed criteria, the FAA stated “loss of communication between the pilot and the UA” when it intended to state “loss of C2 link.”

FAA Response: Communication extends beyond the C2 link and specific control inputs. This is why D&R.001 requires the applicant's CONOPS to include a description of the command, control, and communications functions. As long as the UA operates safely and predictably per its lost link contingency programming logic, a C2 interruption does not constitute a loss of control.

The FAA proposed criteria to address the risks that would result from a lightning strike, accounting for the size and physical limitations of a UAS that could preclude traditional lightning protection features. The FAA further proposed that without lightning protection for the UA, the Flight Manual must include an operating limitation to prohibit flight into weather conditions with potential lightning.

Comment Summary: An individual requested the FAA revise the criteria to include a similar design mitigation or operating limitation for High Intensity Radiated Fields (HIRF). The commenter noted that HIRF is included in proposed UAS.300(e) as part of the expected environmental conditions that must be replicated in testing.

FAA Response: The airworthiness criteria, which are adopted as proposed, address the issue raised by the commenter. The applicant must identify tested HIRF exposure capabilities, if any, in the Flight Manual to comply with the criteria in D&R.200(a)(5). Information regarding HIRF capabilities is necessary for safe operation because proper communication and software execution may be impeded by HIRF-generated interference, which could result in loss of control of the UA. It is not feasible to measure HIRF at every potential location where the UA will operate; thus, requiring operating limitations for HIRF as requested by the commenter would be impractical.

The FAA proposed criteria either requiring that design characteristics protect the UAS from adverse weather conditions or prohibiting flight into known adverse weather conditions. The criteria proposed to define adverse weather conditions as rain, snow, and icing.

Comment Summary: ALPA, Droneport Texas LLC, and two individual commenters requested the FAA expand the proposed definition of adverse weather conditions. These commenters noted that because of the size and physical limitations of the Model 3DR-GS H520-G, adverse weather should also include wind, downdraft, low-level wind shear (LLWS), microburst, and extreme mechanical turbulence.

FAA Response: No additional language needs to be added to the airworthiness criteria to address wind effects. The wind conditions specified by the commenters are part of normal UA flight operations. The applicant must demonstrate by flight test that the UA can withstand wind without failure to meet the requirements of D&R.300(b)(9). The FAA developed the criteria in D&R.130 to address adverse weather conditions (rain, snow, and icing) that would require additional design characteristics for safe operation. Any operating limitations necessary for operation in adverse weather or wind conditions will be included in the Flight Manual as required by D&R.200.

Comment Summary: One commenter questioned whether the criteria proposed in UAS.130(c)(2), requiring a means to detect adverse weather conditions for which the UAS is not certificated to operate, is a prescriptive requirement to install an onboard detection system. The commenter requested, if that was the case, that the FAA allow alternative procedures to avoid flying in adverse weather conditions.

FAA Response: The language referred to by the commenter is not a prescriptive design requirement for an onboard detection system. The applicant may use any acceptable source to monitor weather in the area, whether onboard the UA or from an external source.

The FAA proposed criteria for critical parts that were substantively the same as those in the existing standards for normal category rotorcraft under § 27.602, with changes to reflect UAS terminology and failure conditions. The criteria proposed to define a critical part as a part, the failure of which could result in a loss of flight or unrecoverable loss of control of the aircraft.

Comment Summary: EASA requested the FAA avoid using the term “critical part,” as it is a well-established term for complex manned aircraft categories and may create incorrect expectations on the oversight process for parts.

FAA Response: For purposes of the airworthiness criteria established for the 3DR Model 3DR-GS H520-G UA, the FAA has changed the term “critical part” to “flight essential part.”

Comment Summary: An individual commenter requested the FAA revise the proposed criteria such that a failure of a flight essential part would only occur if there is risk to third parties.

FAA Response: The definition of “flight essential” does not change regardless of whether on-board systems are capable of safely landing the UA when it is unable to continue its flight plan. Tying the definition of a flight essential part to the risk to third parties would result in different definitions for the part depending on where and how the UA is operated. These criteria for the Model 3DR-GS H520-G UA apply the same approach as for manned aircraft.

The FAA proposed criteria for the Flight Manual that were substantively the same as the existing standards for normal category airplanes, with minor changes to reflect UAS terminology.

Comment Summary: ALPA requested the FAA revise the criteria to include normal, abnormal, and emergency operating procedures along with their respective checklist. ALPA further requested the checklist be contained in a quick reference handbook (QRH).

FAA Response: The FAA did not intend for the airworthiness criteria to exclude abnormal procedures from the flight manual. In these final airworthiness criteria, the FAA has changed “normal and emergency operating procedures” to “operating procedures” to encompass all operating conditions and align with 14 CFR 23.2620, which includes the airplane flight manual requirements for normal category airplanes. The FAA has not made any changes to add language that would require the checklists to be included in a QRH. FAA regulations do not require manned aircraft to have a QRH for type certification. Therefore, it would be inconsistent for the FAA to require a QRH for the 3DR Model 3DR-GS H520-G UA.

Comment Summary: ALPA requested the FAA revise the airworthiness criteria to require that the Flight Manual and QRH be readily available to the pilot at the control station.

FAA Response: ALPA's request regarding the Flight manual addresses an operational requirement, similar to 14 CFR 91.9 and is therefore not appropriate for type certification airworthiness criteria. Also, as previously discussed, FAA regulations do not require a QRH. Therefore, it would be inappropriate to require it to be readily available to the pilot at the control station.

Comment Summary: Droneport Texas LLC requested the FAA revise the airworthiness criteria to add required Flight Manual sections for routine maintenance and mission-specific equipment and procedures. The commenter stated that the remote pilot or personnel on the remote pilot-in-command's flight team accomplish most routine maintenance, and that the flight team usually does UA rigging with mission equipment.

FAA Response: The requested change is appropriate for a maintenance document rather than a flight manual because it addresses maintenance procedures rather than the piloting functions. The FAA also notes that, similar to the criteria for certain manned aircraft, the airworthiness criteria require that the applicant prepare instructions for continued airworthiness (ICA) in accordance with Appendix A to Part 23. As the applicant must provide any maintenance instructions and mission-specific information necessary for safe operation and continued operational safety of the UA, in accordance with D&R.205, no changes to the airworthiness criteria are necessary.

Comment Summary: An individual commenter requested the FAA revise the criteria in proposed UAS.200(b) to require that “other information” referred to in proposed UAS.200(a)(5) be approved by the FAA. The commenter noted that, as proposed, only the information listed in UAS.200(a)(1) through (4) must be FAA approved.

FAA Response: The change requested by the commenter would be inconsistent with the FAA's airworthiness standards for flight manuals for manned aircraft. Sections 23.2620(b), 25.1581(b), 27.1581(b), and 29.1581(b) include requirements for flight manuals to include operating limitations, operating procedures, performance information, loading information, and other information that is necessary safe operation because of design, operating, or handling characteristics, but limit FAA approval to operating limitations, operating procedures, performance information, and loading information.

Under § 23.2620(b)(1), for low-speed level 1 and level 2 airplanes, the FAA only approves the operating limitations. In applying a risk-based approach, the FAA has determined it would not be appropriate to hold the lowest risk UA to a higher standard than what is required for low speed level 1 and level 2 manned aircraft. Accordingly, the FAA has revised the airworthiness criteria to only require FAA approval of the operating limitations.

Comment Summary: NUAIR requested the FAA recognize that § 23.2620 is only applicable to the aircraft and does not address off-aircraft components such as the control station, control and non-payload communications (CNPC) data link, and launch and recovery equipment. The commenter noted that this is also true of industry consensus-based standards designed to comply with § 23.2620.

FAA Response: As explained in more detail in the Control Station section of this document, the FAA has revised the airworthiness criteria for the AE. The FAA will approve AE or minimum specifications for the AE that could affect airworthiness as an operating limitation in the UA flight manual. The FAA will establish the approved AE or minimum specifications as operating limitations and include them in the UA type certificate data sheet and Flight Manual in accordance with D&R.105(c). The establishment of requirements for and the approval of AE will be in accordance with FAA Memorandum AIR600-21-AIR-600-PM01, dated July 13, 2021.

The FAA proposed criteria for ICA that were substantively the same as those in the existing standards for normal category airplanes, with minor changes to reflect UA terminology instead of airplane terminology.

Comment Summary: One individual commenter requested the airworthiness criteria contain maintenance, repair, and overhaul standards for the continued safe operation of the UAS after type certification. Specifically, the commenter suggested a maintenance program, maintenance record, maintenance manual, minimum equipment list, illustrated parts catalog, service bulletin, parts manufacturer approval, technical standard order, airworthiness directive, and technician qualification approval systems for each type of commercial UAS.

FAA Response: The airworthiness criteria pertaining to ICA (D&R.205), which are adopted as proposed, require that the applicant prepare ICA in accordance with Appendix A to Part 23, similar to manned aircraft. Appendix A to Part 23 requires maintenance servicing information, instructions, inspection and overhaul periods, and other continued airworthiness information, such as that suggested by the commenter.

The FAA proposed durability and reliability testing that would require the applicant to demonstrate safe flight of the UAS across the entire operational envelope and up to all operational limitations, for all phases of flight and all aircraft configurations described in the applicant's CONOPS, with no failures that result in a loss of flight, loss of control, loss of containment, or emergency landing outside the operator's recovery area. The FAA further proposed that the unmanned aircraft would only be certificated for operations within the limitations, and for flight over areas no greater than the maximum population density, as described in the applicant's CONOPS and demonstrated by test.

Comment Summary: ALPA requested that the proposed certification criteria require all flights during testing be completed in both normal and non-normal or off-nominal scenarios with no failures that result in a loss of flight, loss of control, loss of containment, or emergency landing outside of the operator's recovery zone. Specifically, ALPA stated that testing must not require exceptional piloting skill or alertness and include, at a minimum: All phases of the flight envelope, including the highest UA to pilot ratios; the most adverse combinations of the conditions and configuration; the environmental conditions identified in the CONOPS; the different flight profiles and routes identified in the CONOPS; and exposure to EMI and HIRF.

FAA Response: No change is necessary because the introductory text and paragraphs (b)(7), (b)(9), (b)(10), (b)(13), (c), (d), (e), and (f) of D&R.300, which are adopted as proposed, contain the specific testing requirements requested by ALPA.

Comment Summary: Droneport Texas LLC requested the FAA revise the testing criteria to include, for operation at night, testing both with and without night vision aids. The commenter stated that because small UAS operation at night is waivable under 14 CFR part 107, manufacturers will likely make assumptions concerning a pilot's familiarity with night vision device-aided and unaided operations.

FAA Response: Under D&R.300(b)(11), the applicant must demonstrate by flight test that the UA can operate at night without failure using whatever equipment is onboard the UA itself. The pilot's familiarity, or lack thereof, with night vision equipment does not impact whether the UA is reliable and durable to complete testing without any failures.

Comment Summary: EASA requested the FAA clarify how testing durability and reliability commensurate to the maximum population density, as proposed, aligns with the Specific Operations Risk Assessment (SORA) approach that is open to operational mitigation, reducing the initial ground risk. An individual commenter requested the FAA provide more details about the correlation between the number of flight hours tested and the CONOPS environment ( e.g., population density). The commenter stated that this is one of the most fundamental requirements, and the FAA should ensure equal treatment to all current and future applicants.

FAA Response: In developing these testing criteria, the FAA sought to align the risk of UAS operations with the appropriate level of protection for human beings on the ground. The FAA proposed establishing the maximum population density demonstrated by durability and reliability testing as an operating limitation on the type certificate. However, the FAA has re-evaluated its approach and determined it to be more appropriate to connect the durability and reliability demonstrated during certification testing with the operating environment defined in the CONOPS.

Basing testing on maximum population density may result in limitations not commensurate with many actual operations. As population density broadly refers to the number of people living in a given area per square mile, it does not allow for evaluating variation in a local operating environment. For example, an operator may have a route in an urban environment with the actual flight path along a greenway; the number of human beings exposed to risk from the UA operating overhead would be significantly lower than the population density for the area. Conversely, an operator may have a route over an industrial area where few people live, but where, during business hours, there may be highly dense groups of people. Specific performance characteristics such as altitude and airspeed also factor into defining the boundaries for safe operation of the UA.

Accordingly, the FAA has revised D&R.300 to require the UA design to be durable and reliable when operated under the limitations prescribed for its operating environment. The information in the applicant's CONOPS will determine the operating environment for testing. For example, the minimum hours of reliability testing will be less for a UA conducting agricultural operations in a rural environment than if the same aircraft will be conducting package deliveries in an urban environment. The FAA will include the limitations that result from testing as operating limitations on the type certificate data sheet and in the UA Flight Manual. The FAA intends for this process to be similar to the process for establishing limitations prescribed for special purpose operations for restricted category aircraft. This allows for added flexibility in determining appropriate operating limitations, which will more closely reflect the operating environment.

Finally, a comparison of these criteria with EASA's SORA approach is beyond the scope of this document because the SORA is intended to result in an operational approval rather than a type certificate.

Comment Summary: EASA requested the FAA clarify how reliability at the aircraft level to ensure high-level safety objectives would enable validation of products under applicable bilateral agreements.

FAA Response: As the FAA and international aviation authorities are still developing general airworthiness standards for UA, it would be speculative for the FAA to comment on the validation process for any specific UA.

Comment Summary: EASA requested the FAA revise the testing criteria to include a compliance demonstration related to adverse combinations of the conditions and configurations and with respect to weather conditions and average pilot qualification.

FAA Response: No change is necessary because D&R.300(b)(7), (b)(9), (b)(10), (c), and (f), which are adopted as proposed, contain the specific testing requirements requested by EASA.

Comment Summary: EASA noted that, under the proposed criteria, testing involving a large number of flight hours will limit changes to the configuration.

FAA Response: Like manned aircraft, the requirements of 14 CFR part 21, subpart D, apply to UA for changes to type certificates. The FAA is developing procedures for processing type design changes for UA type certificated using durability and reliability testing.

Comment Summary: EASA requested the FAA clarify whether the proposed testing criteria would require the applicant to demonstrate aspects that do not occur during a successful flight, such as the deployment of emergency recovery systems and fire protection/post-crash fire. EASA asked if these aspects are addressed by other means and what would be the applicable airworthiness criteria.

FAA Response: Equipment not required for normal operation of the UA do not require an evaluation for their specific functionality. D&R testing will show that the inclusion of any such equipment does not prevent normal operation. Therefore, the airworthiness criteria would not require functional testing of the systems described by EASA.

Comment Summary: An individual commenter requested the FAA specify the acceptable percentage of failures in the testing that would result in a “loss of flight.” The Small UAV Coalition requested the FAA clarify what constitutes an emergency landing outside an operator's landing area, as some UAS designs could include an onboard health system that initiates a landing to lessen the potential of a loss of control event. The commenter suggested that, in those cases, a landing in a safe location should not invalidate the test.

FAA Response: The airworthiness criteria require that all test points and flight hours occur with no failures result in a loss of flight, control, containment, or emergency landing outside the operator's recovery zone. The FAA has determined that there is no acceptable percentage of failures in testing. In addition, while the recovery zone may differ for each UAS design, an emergency or unplanned landing outside of a designated landing area would result in a test failure.

Comment Summary: The Small UAV Coalition requested that a single failure during testing not automatically restart counting the number of flight test operations set for a particular population density; rather, the applicant should have the option to identify the failure through root-cause and fault-tree analysis and provide a validated mitigation to ensure it will not recur. An individual commenter requested the FAA to clarify whether the purpose of the tests is to show compliance with a quantitative safety objective. The commenter further requested the FAA allow the applicant to reduce the number of flight testing hours if the applicant can present a predicted safety and reliability analysis.

FAA Response: The intent of the testing criteria is for the applicant to demonstrate the aircraft's durability and reliability through a successful accumulation of flight testing hours. The FAA does not intend to require analytical evaluation to be part of this process. However, the applicant will comply with these testing criteria using a means of compliance, accepted by the FAA, through the issue paper process. The means of compliance will be dependent on the CONOPS the applicant has proposed to meet.

The FAA proposed criteria to evaluate how the UAS functions after probable failures, including failures related to propulsion systems, C2 link, GPS, critical flight control components with a single point of failure, control station, and any other equipment identified by the applicant.

Comment Summary: Droneport Texas LLC requested the FAA add a bird strike to the list of probable failures. The commenter stated that despite sense and avoid technologies, flocks of birds can overcome the maneuver capabilities of a UA and result in multiple, unintended failures.

FAA Response: Unlike manned aircraft, where aircraft size, design, and construct are critical to safe control of the aircraft after encountering a bird strike, the FAA determined testing for bird strike capabilities is not necessary for the Model 3DR-GS H520-G UA. The FAA has determined that a bird strike requirement is not necessary because the smaller size and lower operational speed of the 3DR-GS H520-G reduce the likelihood of a bird strike, combined with the reduced consequences of failure due to no persons onboard. Instead, the FAA is using a risk-based approach to tailor airworthiness requirements commensurate to the low-risk nature of the Model 3DR-GS H520-G UA.

Comment Summary: ALPA requested the FAA require that all probable failure tests occur at the critical phase and mode of flight and at the highest aircraft-to-pilot ratio. ALPA stated the proposed criteria are critically important for systems that rely on a single source to perform multi-label functions, such as GNSS, because failure or interruption of GNSS will lead to loss of positioning, navigation, and timing (PNT) and functions solely dependent on PNT, such as geo-fencing and contingency planning.

FAA Response: No change is necessary because D&R.300(c) requires that the testing occur at the critical phase and mode of flight and at the highest UA-to-pilot ratio.

Comment Summary: Droneport Texas LLC requested the FAA add recovery from vortex ring state (VRS) to the list of probable failures. The commenter stated the UA uses multiple rotors for lift and is therefore susceptible to VRS. The commenter further stated that because recovery from settling with power is beyond a pilot's average skill for purposes of airworthiness testing, the aircraft must be able to sense and recover from this condition without pilot assistance.

FAA Response: D&R.305 addresses probable failures related to specific components of the UAS. VRS is an aerodynamic condition a UA may encounter during flight testing; it is not a component subject to failure.

Comment Summary: Droneport Texas LLC also requested the FAA add a response to the Air Traffic Control-Zero (ATC-Zero) command to the list of probable failures. The commenter stated, based on lessons learned after the attacks on September 11, 2001, aircraft that can fly beyond visual line of sight should be able to respond to an ATC-Zero condition.

FAA Response: The commenter's request is more appropriate for the capabilities and functions testing criteria in D&R.310 than probable failures testing in D&R.305. D&R.310(a)(3) requires the applicant to demonstrate by test that the pilot has the ability to safely discontinue a flight. A pilot may discontinue a flight for a wide variety of reasons, including responding to an ATC-zero command.

Comment Summary: EASA stated the proposed language seems to require an additional analysis and safety assessment, which would be appropriate for the objective requirement of ensuring a probable failure does not result in a loss of containment or control. EASA further stated that an applicant's basic understanding of the systems architecture and effects of failures is essential.

FAA Response: The FAA agrees with the expectation that applicants understand the system architecture and effects of failures of a proposed design, which is why the criteria include a requirement for the applicant to test the specific equipment identified in D&R.305 and identify any other equipment that is not specifically identified in D&R.305 for testing. As the intent of the criteria is for the applicant to demonstrate compliance through testing, some analysis may be necessary to properly identify the appropriate equipment to be evaluated for probable failures.

Comment Summary: An individual requested that probable failure testing apply not only to critical flight control components with a single point of failure, but also to any critical part with a single point of failure.

FAA Response: The purpose of probable failure testing in D&R.305 is to demonstrate that if certain equipment fails, it will fail safely. Adding probable failure testing for critical (now flight essential) parts would not add value to testing. If a part is essential for flight, its failure by definition in D&R.135(a) could result in a loss of flight or unrecoverable loss of control. For example, on a traditional airplane design, failure of a wing spar in flight would lead to loss of the aircraft. Because there is no way to show that a wing spar can fail safely, the applicant must provide its mandatory replacement time if applicable, structural inspection interval, and related structural inspection procedure in the Airworthiness Limitations section of the ICA. Similarly, under these airworthiness criteria, parts whose failure would inherently result in loss of flight or unrecoverable loss of control are not subjected to probable failure testing. Instead, they must be identified as flight essential components and included in the ICA.

To avoid confusion pertaining to probable failure testing, the FAA has removed the word “critical” from D&R.305(a)(5). In the final airworthiness criteria, probable failure testing required by D&R.305(a)(5) applies to “Flight control components with a single point of failure.”

The FAA proposed criteria to require the applicant to demonstrate by test the minimum capabilities and functions necessary for the design. UAS.310(a) proposed to require the applicant to demonstrate, by test, the capability of the UAS to regain command and control of the UA after a C2 link loss, the sufficiency of the electrical system to carry all anticipated loads, and the ability of the pilot to override any pre-programming in order to resolve a potential unsafe operating condition in any phase of flight. UAS.310(b) proposed to require the applicant to demonstrate by test certain features if the applicant requests approval of those features (geo-fencing, external cargo, etc.). UAS.310(c) proposed to require the design of the UAS to safeguard against an unintended discontinuation of flight or release of cargo, whether by human action or malfunction.

Comment Summary: ALPA stated the pilot-in-command must always have the capability to input control changes to the UA and override any pre-programming without delay as needed for the safe management of the flight. The commenter requested that the FAA retain the proposed criteria that would allow the pilot to command to: Regain command and control of the UA after loss of the C2 link; safely discontinue the flight; and dynamically re-route the UA. In support, ALPA stated the ability of the pilot to continually command (re-route) the UA, including termination of the flight if necessary, is critical for safe operations and should always be available to the pilot.

Honeywell requested the FAA revise paragraphs (a)(3) and (a)(4) of the criteria (UAS.310) to allow for either the pilot or an augmenting system to safely discontinue the flight and re-route the UA. The commenter stated that a system comprised of detect and avoid, onboard autonomy, and ground system can be used for these functions. Therefore, the criteria should not require that only the pilot can do them.

An individual commenter requested the FAA remove UAS.310(a)(4) of the proposed criteria because requiring the ability for the pilot to dynamically re-route the UA is too prescriptive and redundant with the proposed requirement in UAS.310(a)(3), the ability of the pilot to discontinue the flight safely.

FAA Response: Because the pilot in command is directly responsible for the operation of the UA, the pilot must have the capability to command actions necessary for continued safety. This includes commanding a change to the flight path or, when appropriate, safely terminating a flight. The FAA notes that the ability for the pilot to safely discontinue a flight means the pilot has the means to terminate the flight and immediately and safely return the UA to the ground. This is different from the pilot having the means to dynamically re-route the UA, without terminating the flight, to avoid a conflict.

Therefore, the final airworthiness criteria include D&R.310(a) as proposed (UAS.310(a)).

Comment Summary: ALPA requested the FAA revise the criteria to require that all equipment, systems, and installations conform, at a minimum, to the standards of § 25.1309.

FAA Response: The FAA determined that traditional methodologies for manned aircraft, including the system safety analysis required by §§ 23.2510, 25.1309, 27.1309, or 29.1309, would be inappropriate to require for the 3DR Model 3DR-GS H520-G due to its smaller size and reduced level of complexity. Instead, the FAA finds that system reliability through testing will ensure the safety of this design.

Comment Summary: ALPA requested the FAA revise the criteria to add a requirement to demonstrate the ability of the UA and pilot to perform all of the contingency plans identified in proposed UAS.120.

FAA Response: No change is necessary because D&R.120 and D&R.305(a)(2), together, require what ALPA requests in its comment. Under D&R.120, the applicant must design the UA to execute a predetermined action in the event of a loss of the C2 link. D&R.305(a)(2) requires the applicant to demonstrate by test that a lost C2 link will not result in a loss of containment or control of the UA. Thus, if the applicant does not demonstrate the predetermined contingency plan resulting from a loss of the C2 link when conducting D&R.305 testing, the test would be a failure due to loss of containment.

Comment Summary: ALPA and an individual commenter requested the FAA revise the criteria so that geo-fencing is a required feature and not optional due to the safety concerns that could result from a UA exiting its operating area.

FAA Response: To ensure safe flight, the applicant must test the proposed safety functions, such as geo-fencing, that are part of the type design of the Model 3DR-GS H520-G UA. The FAA determined that geo-fencing is an optional feature because it is one way, but not the only way, to ensure a safely contained operation.

Comment Summary: ALPA requested the FAA revise the criteria so that capability to detect and avoid other aircraft and obstacles is a required feature and not optional.

FAA Response: D&R.310(a)(4) requires the applicant demonstrate the ability for the pilot to safely re-route the UA in flight to avoid a dynamic hazard. The FAA did not prescribe specific design features such as a collision avoidance system to meet D&R.310(a)(4) because there are multiple means to minimize the risk of collision.

Comment Summary: McMahon Helicopter Services requested that the airworthiness criteria require a demonstration of sense-and-avoid technology that will automatically steer the UA away from manned aircraft, regardless of whether the manned aircraft has a transponder. An individual commenter requested that the FAA require ADS-B in/out and traffic avoidance software on all UAS. The Small UAV Coalition requested the FAA establish standards for collision avoidance technology, as the proposed criteria are not sufficient for compliance with the operational requirement to see and avoid other aircraft (§ 91.113). The commenters stated that these technologies are necessary to avoid a mid-air collision between UA and manned aircraft.

FAA Response: D&R.310(a)(4) requires the applicant demonstrate the ability for the UA to be safely re-routed in flight to avoid a dynamic hazard. The FAA did not prescribe specific design features, such as the technologies suggested by the commenters, to meet D&R.310(a)(4) because they are not the only means for complying with the operational requirement to see and avoid other aircraft. If an applicant chooses to equip their UA with onboard collision avoidance technology, those capabilities and functions must be demonstrated by test per D&R.310(b)(5).

The FAA proposed to require an evaluation of the UA's performance, maneuverability, stability, and control with a factor of safety.

Comment Summary: EASA requested that the FAA revise its approach to require a similar compliance demonstration as EASA's for “light UAS.” EASA stated the FAA's proposed criteria for verification of limits, combined with the proposed Flight Manual requirements, seem to replace a traditional Subpart Flight. 3 EASA further stated the FAA's approach in the proposed airworthiness criteria might necessitate more guidance and means of compliance than the traditional structure.

FAA Response: The FAA's airworthiness criteria will vary from EASA's light UAS certification requirements, resulting in associated differences in compliance demonstrations. At this time, comment on means of compliance and related guidance material, which are still under development with the FAA and with EASA, would be speculative.

Comment Summary: ALPA requested the FAA conduct an analysis to determine battery reliability and safety, taking into account wind and weather conditions and their effect on battery life. ALPA expressed concern with batteries as the only source of power for an aircraft in the NAS. ALPA further requested the FAA not grant exemptions for battery reserve requirements.

FAA Response: Because batteries are a flight essential part, the applicant must establish mandatory instructions or life limits for batteries under the requirements of D&R.135. In addition, when the applicant conducts its D&R testing, D&R.300(i) prevents the applicant from exceeding the maintenance intervals or life limits for those batteries. To the extent the commenter's request addresses fuel reserves, that is an operational requirement, not a certification requirement, and therefore beyond the scope of this document.

Comment Summary: McMahon Helicopter Services requested that the criteria require anti-collision and navigation lighting certified to existing FAA standards for brightness and size. The commenter stated that these standards were based on human factors for nighttime and daytime recognition and are not simply a lighting requirement. An individual commenter requested that the criteria include a requirement for position lighting and anti-collision beacons meeting TSO-30c Level III.

FAA Response: The FAA determined it is unnecessary for these airworthiness criteria to prescribe specific design features for anti-collision or navigation lighting. The FAA will address anti-collision lighting as part of any operational approval, similar to the rules in 14 CFR 107.29(a)(2) and (b) for small UAS.

Comment Summary: ALPA requested the FAA add a new section with minimum standards for Global Navigation Satellite System (GNSS), as the UAS will likely rely heavily upon GNSS for navigation and to ensure that the UA does not stray outside of its approved airspace. ALPA stated that technological advances have made such devices available at an appropriate size, weight, and power for UAs.

FAA Response: The airworthiness criteria in D&R.100 (UA Signal Monitoring and Transmission), D&R.110 (Software), D&R.115 (Cybersecurity), and D&R.305(a)(3) (probable failures related to GPS) sufficiently address design requirements and testing of navigation systems. Even if the applicant uses a TSO-approved GNSS, these airworthiness criteria require a demonstration that the UA operates successfully without loss of containment. Successful completion of these tests demonstrates that the navigation subsystems are acceptable.

Comment Summary: ALPA requested the FAA revise the criteria to add a new section requiring equipage to comply with the FAA's new rules on Remote Identification of Unmanned Aircraft (86 FR 4390, Jan. 15, 2021). An individual commenter questioned the need for public tracking and identification of drones in the event of a crash or violation of FAA flight rules.

FAA Response: The FAA issued the final rule, Remote Identification of Unmanned Aircraft, after providing an opportunity for public notice and comment. The final rule is codified at 14 CFR part 89. Part 89 contains the remote identification requirements for unmanned aircraft certificated and produced under part 21 after September 16, 2022.

Comment Summary: ALPA and one individual questioned the safety of multiple Model 3DR-GS H520-G UA operated by a single pilot, up to a ratio of 20 UA to 1 pilot. ALPA stated that even with high levels of automation, the pilot must still manage the safe operation and maintain situational awareness of multiple aircraft in their flight path, aircraft systems, integration with traffic, obstacles, and other hazards during normal, abnormal, and emergency conditions. As a result, ALPA recommended the FAA conduct additional studies to better understand the feasibility of a single pilot operating multiple UA before developing airworthiness criteria. The Small UAV Coalition requested the FAA provide criteria for an aircraft-to-pilot ratio higher than 20:1.

FAA Response: These airworthiness criteria are specific to the Model 3DR-GS H520-G UA and, as discussed previously in this preamble, operations of the Model 3DR-GS H520-G UA may include multiple UA operated by a single pilot, up to a ratio of 20 UA to 1 pilot. Additionally, these airworthiness criteria require the applicant to demonstrate the durability and reliability of the UA design by flight test, at the highest aircraft-to-pilot ratio, without exceptional piloting skill or alertness. In addition, D&R.305(c) requires the applicant to demonstrate probable failures by test at the highest aircraft-to-pilot ratio. Should the pilot ratio cause a loss of containment or control of the UA, then the applicant will fail this testing.

Comment Summary: ALPA stated that to allow a UAS-pilot ratio of up to 20:1 safely, the possibility that the pilot will need to intervene with multiple UA simultaneously must be “extremely remote.” ALPA questioned whether this is feasible given the threat of GNSS interference or unanticipated wind gusts exceeding operational limits.

FAA Response: The FAA's guidance in AC 23.1309-1E, System Safety Analysis and Assessment for Part 23 Airplanes defines “extremely remote failure conditions” as failure conditions not anticipated to occur during the total life of an airplane, but which may occur a few times when considering the total operational life of all airplanes of the same type. When assessing the likelihood of a pilot needing to intervene with multiple UA simultaneously, the minimum reliability requirements will be determined based on the applicant's proposed CONOPS.

Comment Summary: An individual commenter expressed concern about noise pollution.

FAA Response: The Model 3DR-GS H520-G will need to comply with FAA noise certification standards. If the FAA determines that 14 CFR part 36 does not contain adequate standards for this design, the agency will propose and seek public comment on a rule of particular applicability for noise requirements under a separate rulemaking docket.

Comment Summary: ALPA and McMahon Helicopter Services commented on the operation of UAS at or below 400 feet AGL. ALPA and McMahon Helicopter Services requested the airworthiness criteria contain measures for safe operation at low altitudes so that UAS are not a hazard to manned aircraft, especially operations involving helicopters; air tours; agricultural applications; emergency medical services; air tanker firefighting; power line and pipeline patrol and maintenance; fish and wildlife service; animal control; military and law enforcement; seismic operations; ranching and livestock relocation; and mapping.

FAA Response: The type certificate only establishes the approved design of the UA. These airworthiness criteria require the applicant show compliance for the UA altitude sought for type certification. While this may result in operating limitations in the flight manual, the type certificate is not an approval for operations. Operations and operational requirements are beyond the scope of this document.

Comment Summary: NUAIR requested the FAA complete and publish its draft AC 21.17-XX, Type Certification Basis for Unmanned Aircraft Systems (UAS), to provide additional guidance, including templates, to those who seek a type design approval for UAS. NUAIR also requested the FAA recognize the industry consensus-based standards applicable to UAS, as Transport Canada has by publishing its AC 922-001, Remotely Piloted Aircraft Systems Safety Assurance.

FAA Response: The FAA will continue to develop policy and guidance for UA type certification and will publish guidance as soon as practicable. The FAA encourages consensus standards bodies to develop means of compliance and submit them to the FAA for acceptance. Regarding Transport Canada AC 922-001, that AC addresses operational approval rather than type certification.

Comment Summary: ALPA requested the FAA ensure that operations, including UA integrity, fall under the safety management system. ALPA further requested the FAA convene a Safety Risk Management Panel before allowing operators to commence operations and that the FAA require operators to have an active safety management system, including a non-punitive safety culture, where incident and continuing airworthiness issues can be reported.

FAA Response: The type certificate only establishes the approved design of the UA, including the Flight Manual and ICA. Operations and operational requirements, including safety management and oversight of operations and maintenance, are beyond the scope of this document.

Comment Summary: ALPA supported the FAA's type certification of UAS as a “special class” of aircraft under § 21.17(b) but requested that it be temporary.

FAA Response: As the FAA stated in its notice of policy issued August 11, 2020 (85 FR 58251, September 18, 2020), the FAA will use the type certification process under § 21.17(b) for some unmanned aircraft with no occupants onboard. The FAA further stated in its policy that it may also issue type certificates under § 21.17(a) for airplane and rotorcraft UAS designs where the airworthiness standards in part 23, 25, 27, or 29, respectively, are appropriate. The FAA, in the future, may consider establishing appropriate generally applicable airworthiness standards for UA that are not certificated under the existing standards in parts 23, 25, 27, or 29.

The FAA received and reviewed several comments that were general, stated the commenter's viewpoint or opposition without a suggestion specific to the proposed criteria, or did not make a request the FAA can act on. These comments are beyond the scope of this document.

These airworthiness criteria, established under the provisions of § 21.17(b), are applicable to the 3DR Model 3DR-GS H520-G UA. Should 3DR wish to apply these airworthiness criteria to other UA models, it must submit a new type certification application.

This action affects only certain airworthiness criteria for the 3DR Model 3DR-GS H520-G UA. It is not a standard of general applicability.

The authority citation for these airworthiness criteria is as follows:

Pursuant to the authority delegated to me by the Administrator, the following airworthiness criteria are issued as part of the type certification basis for the 3DR Model 3DR-GS H520-G unmanned aircraft. The FAA finds that compliance with these criteria appropriately mitigates the risks associated with the design and concept of operations and provides an equivalent level of safety to existing rules.

The applicant must define and submit to the FAA a concept of operations (CONOPS) proposal describing the unmanned aircraft system (UAS) operation in the national airspace system for which unmanned aircraft (UA) type certification is requested. The CONOPS proposal must include, at a minimum, a description of the following information in sufficient detail to determine the parameters and extent of testing and operating limitations:

(a) The intended type of operations;

(b) UA specifications;

(c) Meteorological conditions;

(d) Operators, pilots, and personnel responsibilities;

(e) Control station, support equipment, and other associated elements (AE) necessary to meet the airworthiness criteria;

(f) Command, control, and communication functions;

(g) Operational parameters (such as population density, geographic operating boundaries, airspace classes, launch and recovery area, congestion of proposed operating area, communications with air traffic control, line of sight, and aircraft separation); and

(h) Collision avoidance equipment, whether onboard the UA or part of the AE, if requested.

For purposes of these airworthiness criteria, the following definitions apply.

(a) Loss of Control: Loss of control means an unintended departure of an aircraft from controlled flight. It includes control reversal or an undue loss of longitudinal, lateral, and directional stability and control. It also includes an upset or entry into an unscheduled or uncommanded attitude with high potential for uncontrolled impact with terrain. A loss of control means a spin, loss of control authority, loss of aerodynamic stability, divergent flight characteristics, or similar occurrence, which could generally lead to crash.

(b) Loss of Flight: Loss of flight means a UA's inability to complete its flight as planned, up to and through its originally planned landing. It includes scenarios where the UA experiences controlled flight into terrain, obstacles, or any other collision, or a loss of altitude that is severe or non-reversible. Loss of flight also includes deploying a parachute or ballistic recovery system that leads to an unplanned landing outside the operator's designated recovery zone.

The UA must be designed to monitor and transmit to the AE all information required for continued safe flight and operation. This information includes, at a minimum, the following:

(a) Status of all critical parameters for all energy storage systems;

(b) Status of all critical parameters for all propulsion systems;

(c) Flight and navigation information as appropriate, such as airspeed, heading, altitude, and location; and

(d) Communication and navigation signal strength and quality, including contingency information or status.

(a) The applicant must identify and submit to the FAA all AE and interface conditions of the UAS that affect the airworthiness of the UA or are otherwise necessary for the UA to meet these airworthiness criteria. As part of this requirement—

(1) The applicant may identify either specific AE or minimum specifications for the AE.

(i) If minimum specifications are identified, they must include the critical requirements of the AE, including performance, compatibility, function, reliability, interface, pilot alerting, and environmental requirements.

(ii) Critical requirements are those that if not met would impact the ability to operate the UA safely and efficiently.

(2) The applicant may use an interface control drawing, a requirements document, or other reference, titled so that it is clearly designated as AE interfaces to the UA.

(b) The applicant must show the FAA the AE or minimum specifications identified in paragraph (a) of this section meet the following:

(1) The AE provide the functionality, performance, reliability, and information to assure UA airworthiness in conjunction with the rest of the design;

(2) The AE are compatible with the UA capabilities and interfaces;

(3) The AE must monitor and transmit to the pilot all information required for safe flight and operation, including but not limited to those identified in D&R.100; and

(4) The minimum specifications, if identified, are correct, complete, consistent, and verifiable to assure UA airworthiness.

(c) The FAA will establish the approved AE or minimum specifications as operating limitations and include them in the UA type certificate data sheet and Flight Manual.

(d) The applicant must develop any maintenance instructions necessary to address implications from the AE on the airworthiness of the UA. Those instructions will be included in the instructions for continued airworthiness (ICA) required by D&R.205.

To minimize the existence of software errors, the applicant must:

(a) Verify by test all software that may impact the safe operation of the UA;

(b) Utilize a configuration management system that tracks, controls, and preserves changes made to software throughout the entire life cycle; and

(c) Implement a problem reporting system that captures and records defects and modifications to the software.

(a) UA equipment, systems, and networks, addressed separately and in relation to other systems, must be protected from intentional unauthorized electronic interactions that may result in an adverse effect on the security or airworthiness of the UA. Protection must be ensured by showing that the security risks have been identified, assessed, and mitigated as necessary.

(b) When required by paragraph (a) of this section, procedures and instructions to ensure security protections are maintained must be included in the ICA.

(a) The UA must be designed so that, in the event of a loss of the command and control (C2) link, the UA will automatically and immediately execute a safe predetermined flight, loiter, landing, or termination.

(b) The applicant must establish the predetermined action in the event of a loss of the C2 link and include it in the UA Flight Manual.

(c) The UA Flight Manual must include the minimum performance requirements for the C2 data link defining when the C2 link is degraded to a level where remote active control of the UA is no longer ensured. Takeoff when the C2 link is degraded below the minimum link performance requirements must be prevented by design or prohibited by an operating limitation in the UA Flight Manual.

(a) Except as provided in paragraph (b) of this section, the UA must have design characteristics that will protect the UA from loss of flight or loss of control due to lightning.

(b) If the UA has not been shown to protect against lightning, the UA Flight Manual must include an operating limitation to prohibit flight into weather conditions conducive to lightning activity.

(a) For purposes of this section, “adverse weather conditions” means rain, snow, and icing.

(b) Except as provided in paragraph (c) of this section, the UA must have design characteristics that will allow the UA to operate within the adverse weather conditions specified in the CONOPS without loss of flight or loss of control.

(c) For adverse weather conditions for which the UA is not approved to operate, the applicant must develop operating limitations to prohibit flight into known adverse weather conditions and either:

(1) Develop operating limitations to prevent inadvertent flight into adverse weather conditions; or

(2) Provide a means to detect any adverse weather conditions for which the UA is not certificated to operate and show the UA's ability to avoid or exit those conditions.

(a) A flight essential part is a part, the failure of which could result in a loss of flight or unrecoverable loss of UA control.

(b) If the type design includes flight essential parts, the applicant must establish a flight essential parts list. The applicant must develop and define mandatory maintenance instructions or life limits, or a combination of both, to prevent failures of flight essential parts. Each of these mandatory actions must be included in the Airworthiness Limitations Section of the ICA.

The applicant must provide a Flight Manual with each UA.

(a) The UA Flight Manual must contain the following information:

(1) UA operating limitations;

(2) UA operating procedures;

(3) Performance information;

(4) Loading information; and

(5) Other information that is necessary for safe operation because of design, operating, or handling characteristics.

(b) Those portions of the UA Flight Manual containing the information specified in paragraph (a)(1) of this section must be approved by the FAA.

The applicant must prepare ICA for the UA in accordance with Appendix A to Part 23, as appropriate, that are acceptable to the FAA. The ICA may be incomplete at type certification if a program exists to ensure their completion prior to delivery of the first UA or issuance of a standard airworthiness certificate, whichever occurs later.

The UA must be designed to be durable and reliable when operated under the limitations prescribed for its operating environment, as documented in its CONOPS and included as operating limitations on the type certificate data sheet and in the UA Flight Manual. The durability and reliability must be demonstrated by flight test in accordance with the requirements of this section and completed with no failures that result in a loss of flight, loss of control, loss of containment, or emergency landing outside the operator's recovery area.

(a) Once a UA has begun testing to show compliance with this section, all flights for that UA must be included in the flight test report.

(b) Tests must include an evaluation of the entire flight envelope across all phases of operation and must address, at a minimum, the following:

(1) Flight distances;

(2) Flight durations;

(3) Route complexity;

(4) Weight;

(5) Center of gravity;

(6) Density altitude;

(7) Outside air temperature;

(8) Airspeed;

(9) Wind;

(10) Weather;

(11) Operation at night, if requested;

(12) Energy storage system capacity; and

(13) Aircraft to pilot ratio.

(c) Tests must include the most adverse combinations of the conditions and configurations in paragraph (b) of this section.

(d) Tests must show a distribution of the different flight profiles and routes representative of the type of operations identified in the CONOPS.

(e) Tests must be conducted in conditions consistent with the expected environmental conditions identified in the CONOPS, including electromagnetic interference (EMI) and high intensity radiated fields (HIRF).

(f) Tests must not require exceptional piloting skill or alertness.

(g) Any UAS used for testing must be subject to the same worst-case ground handling, shipping, and transportation loads as those allowed in service.

(h) Any UA used for testing must use AE that meet, but do not exceed, the minimum specifications identified under D&R.105. If multiple AE are identified, the applicant must demonstrate each configuration.

(i) Any UAS used for testing must be maintained and operated in accordance with the ICA and UA Flight Manual. No maintenance beyond the intervals established in the ICA will be allowed to show compliance with this section.

(j) If cargo operations or external-load operations are requested, tests must show, throughout the flight envelope and with the cargo or external-load at the most critical combinations of weight and center of gravity, that—

(1) The UA is safely controllable and maneuverable; and

(2) The cargo or external-load are retainable and transportable.

The UA must be designed such that a probable failure will not result in a loss of containment or control of the UA. This must be demonstrated by test.

(a) Probable failures related to the following equipment, at a minimum, must be addressed:

(1) Propulsion systems;

(2) C2 link;

(3) Global Positioning System (GPS);

(4) Flight control components with a single point of failure;

(5) Control station; and

(6) Any other AE identified by the applicant.

(b) Any UA used for testing must be operated in accordance with the UA Flight Manual.

(c) Each test must occur at the critical phase and mode of flight, and at the highest aircraft-to-pilot ratio.

(a) All of the following required UAS capabilities and functions must be demonstrated by test:

(1) Capability to regain command and control of the UA after the C2 link has been lost.

(2) Capability of the electrical system to power all UA systems and payloads.

(3) Ability for the pilot to safely discontinue the flight.

(4) Ability for the pilot to dynamically re-route the UA.

(5) Ability to safely abort a takeoff.

(6) Ability to safely abort a landing and initiate a go-around.

(b) The following UAS capabilities and functions, if requested for approval, must be demonstrated by test:

(1) Continued flight after degradation of the propulsion system.

(2) Geo-fencing that contains the UA within a designated area, in all operating conditions.

(3) Positive transfer of the UA between control stations that ensures only one control station can control the UA at a time.

(4) Capability to release an external cargo load to prevent loss of control of the UA.

(5) Capability to detect and avoid other aircraft and obstacles.

(c) The UA must be designed to safeguard against inadvertent discontinuation of the flight and inadvertent release of cargo or external load.

The structure of the UA must be shown to withstand the repeated loads expected during its service life without failure. A life limit for the airframe must be established, demonstrated by test, and included in the ICA.

The performance, maneuverability, stability, and control of the UA within the flight envelope described in the UA Flight Manual must be demonstrated at a minimum of 5% over maximum gross weight with no loss of control or loss of flight.

Wingcopter GmbH (Wingcopter) applied to the FAA on March 17, 2020, for a special class type certificate under title 14, Code of Federal Regulations (14 CFR), § 21.17(b) for the Model 198 US unmanned aircraft system (UAS).

The Model 198 US consists of a powered lift UA and its associated elements (AE) including communication links and components that control the UA. The Model 198 US UA has a maximum gross takeoff weight of 53 pounds. It has a wingspan of approximately 78 inches, is approximately 60 inches in length, and 22 inches in height. The Model 198 US UA uses battery-powered electric motors for vertical takeoff, landing, and forward flight. The UAS operations would rely on high levels of automation and may include multiple UA operated by a single pilot, up to a ratio of 20 UA to 1 pilot. Wingcopter anticipates operators will use the Model 198 US for delivering packages. The proposed concept of operations (CONOPS) for the Model 198 US identifies a maximum operating altitude of 400 feet above ground level (AGL), a maximum cruise speed of 70 knots, operations beyond visual line of sight (BVLOS) of the pilot, and operations over human beings. Wingcopter has not requested type certification for flight into known icing for the Model 198 US.

The FAA issued a notice of proposed airworthiness criteria for the Wingcopter 198 US UAS, which published in the Federal Register on November 20, 2020 (85 FR 74275).

Based on the comments received, these final airworthiness criteria reflect the following changes, as explained in more detail under Discussion of Comments: A new section containing definitions; revisions to the CONOPS requirement; changing the term “critical part” to “flight essential part” in D&R.135; changing the basis of the durability and reliability testing from population density to limitations prescribed for the operating environment identified in the applicant's CONOPS per D&R.001; and, for the demonstration of certain required capabilities and functions as required by D&R.310.

Additionally, the FAA re-evaluated its approach to type certification of low-risk UA using durability and reliability testing. Safe UAS operations depend and rely on both the UA and the AE. As explained in FAA Memorandum AIR600-21-AIR-600-PM01, dated July 13, 2021, the FAA has revised the airworthiness criteria to define a boundary between the UA type certification and subsequent operational evaluations and approval processes for the UAS ( i.e., waivers, exemptions, and/or operating certificates).

To reflect that these airworthiness criteria rely on durability and reliability (D&R) testing for certification, the FAA changed the prefix of each section from “UAS” to “D&R.”

Lastly, the FAA revised D&R.001(g) to clarify that the operational parameters listed in that paragraph are examples and not an all-inclusive list.

The FAA received responses from 15 commenters. The majority of the commenters were individuals. In addition to the individuals' comments, the FAA also received comments from the European Union Aviation Safety Agency (EASA), unmanned aircraft manufacturers, a helicopter operator, and organizations such as the Air Line Pilots Association (ALPA), Droneport Texas, LLC, the National Agricultural Aviation Association (NAAA), Northeast UAS Airspace Integration Research Alliance, Inc. (NUAIR), and the Small UAV Coalition.

Comment Summary: ALPA, NUAIR, and the Small UAV Coalition expressed support for type certification as a special class of aircraft and establishing airworthiness criteria under § 21.17(b). The Small UAV Coalition also supported the FAA's proposed use of performance-based standards.

Comment Summary: An individual commenter requested the FAA define the term “loss of flight” and clarify how it is different from “loss of control.” The commenter questioned whether loss of flight meant the UA could not continue its intended flight plan but could safely land or terminate the flight.

FAA Response: The FAA has added a new section, D&R.005, to define the terms “loss of flight” and “loss of control” for the purposes of these airworthiness criteria. “Loss of flight” refers to a UA's inability to complete its flight as planned, up to and through its originally planned landing. “Loss of flight” includes scenarios where the UA experiences controlled flight into terrain or obstacles, or any other collision, or a loss of altitude that is severe or non-recoverable. “Loss of flight” includes deploying a parachute or ballistic recovery system that leads to an unplanned landing outside the operator's designated recovery zone.

“Loss of control” means an unintended departure of an aircraft from controlled flight. It includes control reversal or an undue loss of longitudinal, lateral, and directional stability and control. It also includes an upset or entry into an unscheduled or uncommanded attitude with high potential for uncontrolled impact with terrain. “Loss of control” means a spin, loss of control authority, loss of aerodynamic stability, divergent flight characteristic, or similar occurrence, which could generally lead to a crash.

Comment Summary: Two commenters requested the FAA clarify terminology with respect to piloting skill and alertness. Droneport Texas LLC stated that the average pilot skill and alertness is currently undefined, as remote pilots do not undergo oral or practical examinations to obtain certification. NUAIR noted that, despite the definition of “exceptional piloting skill and alertness” in Advisory Circular (AC) 23-8C, Flight Test Guide for Certification of Part 23 Airplanes, there is a significant difference between the average skill and alertness of a remote pilot certified under 14 CFR part 107 and a pilot certified under 14 CFR part 61. The commenter requested the FAA clarify the minimum qualifications and ratings to perform as a remote pilot of a UAS with a type certificate.

FAA Response: These airworthiness criteria do not require exceptional piloting skill and alertness for testing. The FAA included this as a requirement to ensure the applicant passes testing by using pilots of average skill who have been certificated under part 61, as opposed to highly trained pilots with thousands of hours of flight experience.

The FAA proposed a requirement for the applicant to submit a CONOPS describing the UAS and identifying the intended operational concepts. The FAA explained in the preamble of the notice of proposed airworthiness criteria that the information in the CONOPS would determine parameters for testing and flight manual operating limitations.

Comment Summary: One commenter stated that the airworthiness criteria are generic and requested the FAA add language to proposed UAS.001 to clarify that some of the criteria may not be relevant or necessary.

FAA Response: Including the language requested by the commenter would be inappropriate, as these airworthiness criteria are project-specific. Thus, in this case, each element of these airworthiness criteria is a requirement specific to the type certification of Wingcopter's proposed UA design.

Comment Summary: ALPA requested the criteria specify that the applicant's CONOPS contain sufficient detail to determine the parameters and extent of testing, as well as operating limitations placed on the UAS for its operational uses.

FAA Response: The FAA agrees and has updated D&R.001 to clarify that the information required for inclusion in the CONOPS proposal (D&R.001(a) through (g)), must be described in sufficient detail to determine the parameters and extent of testing and operating limitations.

Comment Summary: ALPA requested the CONOPS include a description of a means to ensure separation from other aircraft and perform collision avoidance maneuvers. ALPA stated that its requested addition to the CONOPS is critical to the safety of other airspace users, as manned aircraft do not easily see most UAs.

FAA Response: The FAA agrees and has updated D&R.001 to require that the applicant identify collision avoidance equipment (whether onboard the UA or part of the AE), if the applicant requests to include that equipment.

Comment Summary: ALPA requested the FAA add security-related (other than cyber-security) requirements to the CONOPS criteria, including mandatory reporting of security occurrences, security training and awareness programs for all personnel involved in UAS operations, and security standards for the transportation of goods, similar to those for manned aviation.

FAA Response: The type certificate only establishes the approved design of the UA. Operations and operational requirements, including those regarding security occurrences, security training, and package delivery security standards (other than cybersecurity airworthiness design requirements) are beyond the scope of the airworthiness criteria established by this document and are not required for type certification.

Comment Summary: UAS.001(c) proposed to require that the applicant's CONOPS include a description of meteorological conditions. ALPA requested the FAA change UAS.001(c) to require a description of meteorological and environmental conditions and their operational limits. ALPA stated the CONOPS should include maximum wind speeds, maximum or minimum temperatures, maximum density altitudes, and other relevant phenomena that will limit operations or cause operations to terminate.

FAA Response: D&R.001(c) and D&R.125 address meteorological conditions, while D&R.001(g) addresses environmental considerations. The FAA determined that these criteria are sufficient to cover the weather phenomena mentioned by the commenter without specifically requiring identification of related operational limits.

To address the risks associated with loss of control of the UA, the FAA proposed that the applicant design the control station to provide the pilot with all information necessary for continued safe flight and operation.

Comment Summary: ALPA and two individual commenters requested the FAA revise the proposed criteria to add requirements for the control station. Specifically, these commenters requested the FAA include the display of data and alert conditions to the pilot, physical security requirements for both the control station and the UAS storage area, design requirements that minimize negative impact of extended periods of low pilot workload, transfer of control between pilots, and human factors/human machine interface considerations for handheld controls. NUAIR requested the FAA designate the control station as a flight critical component for operations.

EASA and an individual commenter requested the FAA consider flexibility in some of the proposed criteria. EASA stated that the list of information in proposed UAS.100 is too prescriptive and contains information that may not be relevant for highly automated systems. The individual commenter requested that the FAA allow part-time or non-continuous displays of required information that do not influence the safety of the flight.

FAA Response: Although the scope of the proposed airworthiness criteria applied to the entire UAS, the FAA has re-evaluated its approach to type certification of low-risk unmanned aircraft using durability and reliability testing. A UA is an aircraft that is operated without the possibility of direct human intervention from within or on the aircraft. 1 A UAS is defined as a UA and its AE, including communication links and the components that control the UA, that are required to operate the UAS safely and efficiently in the national airspace system. 2 As explained in FAA Memorandum AIR600-21-AIR-600-PM01, dated July 13, 2021, the FAA determined it will apply the regulations for type design approval, production approval, conformity, certificates of airworthiness, and maintenance to only the UA and not to the AE. However, because safe UAS operations depend and rely on both the UA and the AE, the FAA will consider the AE in assessing whether the UA meets the airworthiness criteria that comprise the certification basis.

While the AE items themselves will be outside the scope of the UA type design, the applicant will provide sufficient specifications for any aspect of the AE, including the control station, which could affect airworthiness. The FAA will approve either the specific AE or minimum specifications for the AE, as identified by the applicant, as part of the type certificate by including them as an operating limitation in the type certificate data sheet and flight manual. The FAA may impose additional operating limitations specific to the AE through conditions and limitations for inclusion in the operational approval ( i.e., waivers, exemptions, or a combination of these). In accordance with this approach, the FAA will consider the entirety of the UAS for operational approval and oversight.

Accordingly, the FAA has revised the criteria by replacing proposed section UAS.100, applicable to the control station design, with D&R.100, UA Signal Monitoring and Transmission, with substantively similar criteria that apply to the UA design.

The FAA has also added a new section, D&R.105, UAS AE Required for Safe UA Operations, which requires the applicant to provide information concerning the specifications of the AE The FAA has moved the alert function requirement proposed in UAS.100(a) to new section D&R.105(a)(1)(i). As part of the clarification of the testing of the interaction between the UA and AE, the FAA has added a requirement to D&R.300(h) for D&R testing to use minimum specification AE. This addition requires the applicant to demonstrate that the limits proposed for those AE will allow the UA to operate as expected throughout its service life. Finally, the FAA has revised references throughout the airworthiness criteria from “UAS” to “UA,” as appropriate, to reflect the FAA determination that the regulations for type design approval, production approval, conformity, certificates of airworthiness, and maintenance apply to only the UA.

The FAA proposed criteria on verification, configuration management, and problem reporting to minimize the existence of errors associated with UAS software.

Comment Summary: ALPA requested the FAA add language to the proposed criteria to ensure that some level of software engineering principles are used without being too prescriptive.

FAA Response: By combining the software-testing requirement of D&R.110(a) with successful completion of the requirements in the entire “Testing” subpart, the acceptable level of software assurance will be identified and demonstrated. The configuration management system required by D&R.110(b) will ensure that the software is adequately documented and traceable both during and after the initial type certification activities.

Comment Summary: EASA suggested the criteria require that the applicant establish and correctly implement system requirements or a structured software development process for critical software.

FAA Response: Direct and specific evaluation of the software development process is more detailed than what the FAA intended with the proposed criteria, which use D&R testing to evaluate the UAS as a whole system, rather than evaluating individual components within the UA. Successful completion of the testing requirements provides confidence that the components that make up the UA provide an acceptable level of safety, commensurate to the low-risk nature of this aircraft. The FAA finds no change to the airworthiness criteria is needed.

Comment Summary: Two individual commenters requested the FAA require the manned aircraft software certification methodology in RTCA DO-178C, Software Considerations in Airborne Systems and Equipment Certification, for critical UA software.

FAA Response: Under these airworthiness criteria, only software that may affect the safe operation of the UA must be verified by test. To verify by test, the applicant will need to provide an assessment showing that other software is not subject to testing because it has no impact on the safe operation of the UA. For software that is subject to testing, the FAA may accept multiple options for software qualification, including DO-178C. Further, specifying that applicants must comply with DO-178 would be inconsistent with the FAA's intent to issue performance-based airworthiness criteria.

Comment Summary: NAAA stated that an overreliance of software in aircraft has been and continues to be a source of accidents and requested the FAA include criteria to prevent a midair collision.

FAA Response: The proper functioning of software is an important element of type certification, particularly with respect to flight controls and navigation. The airworthiness criteria in D&R.110 are meant to provide an acceptable level of safety commensurate with the risk posed by this UA. Additionally, the airworthiness criteria require contingency planning per D&R.120 and the demonstration of the UA's ability to detect and avoid other aircraft in D&R.310, if requested by the applicant. The risk of a midair collision will be minimized by the operating limitations that result from testing based on the operational parameters identified by the applicant in its CONOPS (such as geographic operating boundaries, airspace classes, and congestion of the proposed operating area), rather than by specific mitigations built into the aircraft design itself. These criteria are sufficient due to the low-risk nature of the Model 198 US.

Because the UA requires a continuous wireless connection, the FAA proposed criteria to address the risks to the UAS from cybersecurity threats.

Comment Summary: ALPA requested adding a requirement for cybersecurity protection for navigation and position reporting systems such as Global Navigation Satellite System (GNSS). ALPA further requested the FAA include criteria to address specific cybersecurity vulnerabilities, such as jamming (denial of signal) and spoofing (false position data is inserted). ALPA stated that, for navigation, UAS primarily use GNSS—an unencrypted, open-source, low power transmission that can be jammed, spoofed, or otherwise manipulated.

FAA Response: The FAA will assess elements directly influencing the UA for cybersecurity under D&R.115 and will assess the AE as part of any operational approvals an operator may seek. D&R.115 (proposed as UAS.115) addresses intentional unauthorized electronic interactions, which includes, but is not limited to, hacking, jamming, and spoofing. These airworthiness criteria require the high-level outcome the UA must meet, rather than discretely identifying every aspect of cybersecurity the applicant will address.

The FAA proposed criteria requiring that the UAS be designed to automatically execute a predetermined action in the event of a loss of communication between the pilot and the UA. The FAA further proposed that the predetermined action be identified in the Flight Manual and that the UA be precluded from taking off when the quality of service is inadequate.

Comment Summary: ALPA requested the criteria encompass more than loss or degradation of the command and control (C2) link, as numerous types of critical part or systems failures can occur that include degraded capabilities, whether intermittent or sustained. ALPA requested the FAA add language to the proposed criteria to address specific failures such as loss of a primary navigation sensor, degradation or loss of navigation capability, and simultaneous impact of C2 and navigation links.

FAA Response: The airworthiness criteria address the issues raised by ALPA. Specifically, D&R.120(a) addresses actions the UA will automatically and immediately take when the operator no longer has control of the UA. Should the specific failures identified by ALPA result in the operator's loss of control, then the criteria require the UA to execute a predetermined action. Degraded navigation performance does not raise the same level of concern as a degraded or lost C2 link. For example, a UA may experience interference with a GPS signal on the ground, but then find acceptable signal strength when above a tree line or other obstruction. The airworthiness criteria require that neither degradation nor complete loss of GPS or C2, as either condition would be a failure of that system, result in unsafe loss of control or containment. The applicant must demonstrate this by test to meet the requirements of D&R.305(a)(3).

Under the airworthiness criteria, the minimum performance requirements for the C2 link, defining when the link is degraded to an unacceptable level, may vary among different UAS designs. The level of degradation that triggers a loss is dependent upon the specific UA characteristics; this level will be defined by the applicant and demonstrated to be acceptable by testing as required by D&R.305(a)(2) and D&R.310(a)(1).

Comment Summary: An individual commenter requested the FAA use distinct terminology for “communication,” used for communications with air traffic control, and “C2 link,” used for command and control between the remote pilot station and UA. The commenter questioned whether, in the proposed criteria, the FAA stated “loss of communication between the pilot and the UA” when it intended to state “loss of C2 link.”

FAA Response: Communication extends beyond the C2 link and specific control inputs. This is why D&R.001 requires the applicant's CONOPS to include a description of the command, control, and communications functions. As long as the UA operates safely and predictably per its lost link contingency programming logic, a C2 interruption does not constitute a loss of control.

The FAA proposed criteria to address the risks that would result from a lightning strike, accounting for the size and physical limitations of a UAS that could preclude traditional lightning protection features. The FAA further proposed that without lightning protection for the UA, the Flight Manual must include an operating limitation to prohibit flight into weather conditions with potential lightning.

Comment Summary: An individual requested the FAA revise the criteria to include a similar design mitigation or operating limitation for High Intensity Radiated Fields (HIRF). The commenter noted that HIRF is included in proposed UAS.300(e) as part of the expected environmental conditions that must be replicated in testing.

FAA Response: The airworthiness criteria, which are adopted as proposed, address the issue raised by the commenter. The applicant must identify tested HIRF exposure capabilities, if any, in the Flight Manual to comply with the criteria in D&R.200(a)(5). Information regarding HIRF capabilities is necessary for safe operation because proper communication and software execution may be impeded by HIRF-generated interference, which could result in loss of control of the UA. It is not feasible to measure HIRF at every potential location where the UA will operate; thus, requiring operating limitations for HIRF as requested by the commenter would be impractical.

The FAA proposed criteria either requiring that design characteristics protect the UAS from adverse weather conditions or prohibiting flight into known adverse weather conditions. The criteria proposed to define adverse weather conditions as rain, snow, and icing.

Comment Summary: ALPA and two individual commenters requested the FAA expand the proposed definition of adverse weather conditions. These commenters noted that because of the size and physical limitations of the Model 198 US, adverse weather should also include wind, downdraft, low-level wind shear (LLWS), microburst, and extreme mechanical turbulence.

FAA Response: No additional language needs to be added to the airworthiness criteria to address wind effects. The wind conditions specified by the commenters are part of normal UA flight operations. The applicant must demonstrate by flight test that the UA can withstand wind without failure to meet the requirements of D&R.300(b)(9). The FAA developed the criteria in D&R.130 to address adverse weather conditions (rain, snow, and icing) that would require additional design characteristics for safe operation. Any operating limitations necessary for operation in adverse weather or wind conditions will be included in the Flight Manual as required by D&R.200.

Comment Summary: One commenter questioned whether the criteria proposed in UAS.130(c)(2), requiring a means to detect adverse weather conditions for which the UAS is not certificated to operate, is a prescriptive requirement to install an onboard detection system. The commenter requested, if that was the case, that the FAA allow alternative procedures to avoid flying in adverse weather conditions.

FAA Response: The language referred to by the commenter is not a prescriptive design requirement for an onboard detection system. The applicant may use any acceptable source to monitor weather in the area, whether onboard the UA or from an external source.

The FAA proposed criteria for critical parts that were substantively the same as those in the existing standards for normal category rotorcraft under § 27.602, with changes to reflect UAS terminology and failure conditions. The criteria proposed to define a critical part as a part, the failure of which could result in a loss of flight or unrecoverable loss of control of the aircraft.

Comment Summary: EASA requested the FAA avoid using the term “critical part,” as it is a well-established term for complex manned aircraft categories and may create incorrect expectations on the oversight process for parts.

FAA Response: For purposes of the airworthiness criteria established for the Wingcopter Model 198 US UA, the FAA has changed the term “critical part” to “flight essential part.”

Comment Summary: An individual commenter requested the FAA revise the proposed criteria such that a failure of a flight essential part would only occur if there is risk to third parties.

FAA Response: The definition of “flight essential” does not change regardless of whether on-board systems are capable of safely landing the UA when it is unable to continue its flight plan. Tying the definition of a flight essential part to the risk to third parties would result in different definitions for the part depending on where and how the UA is operated. These criteria for the Model 198 US UA apply the same approach as for manned aircraft.

The FAA proposed criteria for the Flight Manual that were substantively the same as the existing standards for normal category airplanes, with minor changes to reflect UAS terminology.

Comment Summary: ALPA requested the FAA revise the criteria to include normal, abnormal, and emergency operating procedures along with their respective checklist. ALPA further requested the checklist be contained in a quick reference handbook (QRH).

FAA Response: The FAA did not intend for the airworthiness criteria to exclude abnormal procedures from the flight manual. In these final airworthiness criteria, the FAA has changed “normal and emergency operating procedures” to “operating procedures” to encompass all operating conditions and align with 14 CFR 23.2620, which includes the airplane flight manual requirements for normal category airplanes. The FAA has not made any changes to add language that would require the checklists to be included in a QRH. FAA regulations do not require manned aircraft to have a QRH for type certification. Therefore, it would be inconsistent for the FAA to require a QRH for the Wingcopter Model 198 US UA.

Comment Summary: ALPA requested the FAA revise the airworthiness criteria to require that the Flight Manual and QRH be readily available to the pilot at the control station.

FAA Response: ALPA's request regarding the Flight manual addresses an operational requirement, similar to 14 CFR 91.9 and is therefore not appropriate for type certification airworthiness criteria. Also, as previously discussed, FAA regulations do not require a QRH. Therefore, it would be inappropriate to require it to be readily available to the pilot at the control station.

Comment Summary: Droneport Texas LLC requested the FAA revise the airworthiness criteria to add required Flight Manual sections for routine maintenance and mission-specific equipment and procedures. The commenter stated that the remote pilot or personnel on the remote pilot-in-command's flight team accomplish most routine maintenance, and that the flight team usually does UA rigging with mission equipment.

FAA Response: The requested change is appropriate for a maintenance document rather than a flight manual because it addresses maintenance procedures rather than the piloting functions. The FAA also notes that, similar to the criteria for certain manned aircraft, the airworthiness criteria require that the applicant prepare instructions for continued airworthiness (ICA) in accordance with appendix A to part 23. As the applicant must provide any maintenance instructions and mission-specific information necessary for safe operation and continued operational safety of the UA, in accordance with D&R.205, no changes to the airworthiness criteria are necessary.

Comment Summary: An individual commenter requested the FAA revise the criteria in proposed UAS.200(b) to require that “other information” referred to in proposed UAS.200(a)(5) be approved by the FAA. The commenter noted that, as proposed, only the information listed in UAS.200(a)(1) through (4) must be FAA approved.

FAA Response: The change requested by the commenter would be inconsistent with the FAA's airworthiness standards for flight manuals for manned aircraft. Sections 23.2620(b), 25.1581(b), 27.1581(b), and 29.1581(b) include requirements for flight manuals to include operating limitations, operating procedures, performance information, loading information, and other information that is necessary safe operation because of design, operating, or handling characteristics, but limit FAA approval to operating limitations, operating procedures, performance information, and loading information.

Under § 23.2620(b)(1), for low-speed level 1 and level 2 airplanes, the FAA only approves the operating limitations. In applying a risk-based approach, the FAA has determined it would not be appropriate to hold the lowest risk UA to a higher standard than what is required for low speed level 1 and level 2 manned aircraft. Accordingly, the FAA has revised the airworthiness criteria to only require FAA approval of the operating limitations.

Comment Summary: NUAIR requested the FAA recognize that § 23.2620 is only applicable to the aircraft and does not address off-aircraft components such as the control station, control and non-payload communications (CNPC) data link, and launch and recovery equipment. The commenter noted that this is also true of industry consensus-based standards designed to comply with § 23.2620.

FAA Response: As explained in more detail in the Control Station section of this document, the FAA has revised the airworthiness criteria for the AE. The FAA will approve AE or minimum specifications for the AE that could affect airworthiness as an operating limitation in the UA flight manual. The FAA will establish the approved AE or minimum specifications as operating limitations and include them in the UA type certificate data sheet and Flight Manual in accordance with D&R.105(c). The establishment of requirements for, and the approval of AE will be in accordance with FAA Memorandum AIR600-21-AIR-600-PM01, dated July 13, 2021.

The FAA proposed durability and reliability testing that would require the applicant to demonstrate safe flight of the UAS across the entire operational envelope and up to all operational limitations, for all phases of flight and all aircraft configurations described in the applicant's CONOPS, with no failures that result in a loss of flight, loss of control, loss of containment, or emergency landing outside the operator's recovery area. The FAA further proposed that the unmanned aircraft would only be certificated for operations within the limitations, and for flight over areas no greater than the maximum population density, as described in the applicant's CONOPS and demonstrated by test.

Comment Summary: ALPA requested that the proposed certification criteria require all flights during testing be completed in both normal and non-normal or off-nominal scenarios with no failures that result in a loss of flight, loss of control, loss of containment, or emergency landing outside of the operator's recovery zone. Specifically, ALPA stated that testing must not require exceptional piloting skill or alertness and include, at a minimum: All phases of the flight envelope, including the highest UA to pilot ratios; the most adverse combinations of the conditions and configuration; the environmental conditions identified in the CONOPS; the different flight profiles and routes identified in the CONOPS; and exposure to EMI and HIRF.

FAA Response: No change is necessary because the introductory text and paragraphs (b)(7), (b)(9), (b)(10), (b)(13), (c), (d), (e), and (f) of D&R.300, which are adopted as proposed, contain the specific testing requirements requested by ALPA.

Comment Summary: Droneport Texas LLC requested the FAA revise the testing criteria to include, for operation at night, testing both with and without night vision aids. The commenter stated that because small UAS operation at night is waivable under 14 CFR part 107, manufacturers will likely make assumptions concerning a pilot's familiarity with night vision device-aided and unaided operations.

FAA Response: Under D&R.300(b)(11), the applicant must demonstrate by flight test that the UA can operate at night without failure using whatever equipment is onboard the UA itself. The pilot's familiarity, or lack thereof, with night vision equipment does not impact whether the UA is reliable and durable to complete testing without any failures.

Comment Summary: EASA requested the FAA clarify how testing durability and reliability commensurate to the maximum population density, as proposed, aligns with the Specific Operations Risk Assessment (SORA) approach that is open to operational mitigation, reducing the initial ground risk. An individual commenter requested the FAA provide more details about the correlation between the number of flight hours tested and the CONOPS environment ( e.g., population density). The commenter stated that this is one of the most fundamental requirements, and the FAA should ensure equal treatment to all current and future applicants.

FAA Response: In developing these testing criteria, the FAA sought to align the risk of UAS operations with the appropriate level of protection for human beings on the ground. The FAA proposed establishing the maximum population density demonstrated by durability and reliability testing as an operating limitation on the type certificate. However, the FAA has re-evaluated its approach and determined it to be more appropriate to connect the durability and reliability demonstrated during certification testing with the operating environment defined in the CONOPS.

Basing testing on maximum population density may result in limitations not commensurate with many actual operations. As population density broadly refers to the number of people living in a given area per square mile, it does not allow for evaluating variation in a local operating environment. For example, an operator may have a route in an urban environment with the actual flight path along a greenway; the number of human beings exposed to risk from the UA operating overhead would be significantly lower than the population density for the area. Conversely, an operator may have a route over an industrial area where few people live, but where, during business hours, there may be highly dense groups of people. Specific performance characteristics such as altitude and airspeed also factor into defining the boundaries for safe operation of the UA.

Accordingly, the FAA has revised D&R.300 to require the UA design to be durable and reliable when operated under the limitations prescribed for its operating environment. The information in the applicant's CONOPS will determine the operating environment for testing. For example, the minimum hours of reliability testing will be less for a UA conducting agricultural operations in a rural environment than if the same aircraft will be conducting package deliveries in an urban environment. The FAA will include the limitations that result from testing as operating limitations on the type certificate data sheet and in the UA Flight Manual. The FAA intends for this process to be similar to the process for establishing limitations prescribed for special purpose operations for restricted category aircraft. This allows for added flexibility in determining appropriate operating limitations, which will more closely reflect the operating environment.

Finally, a comparison of these criteria with EASA's SORA approach is beyond the scope of this document because the SORA is intended to result in an operational approval rather than a type certificate.

Comment Summary: EASA requested the FAA clarify how reliability at the aircraft level to ensure high-level safety objectives would enable validation of products under applicable bilateral agreements.

FAA Response: As the FAA and international aviation authorities are still developing general airworthiness standards for UA, it would be speculative for the FAA to comment on the validation process for any specific UA.

Comment Summary: EASA requested the FAA revise the testing criteria to include a compliance demonstration related to adverse combinations of the conditions and configurations and with respect to weather conditions and average pilot qualification.

FAA Response: No change is necessary because D&R.300(b)(7), (b)(9), (b)(10), (c), and (f), which are adopted as proposed, contain the specific testing requirements requested by EASA.

Comment Summary: EASA noted that, under the proposed criteria, testing involving a large number of flight hours will limit changes to the configuration.

FAA Response: Like manned aircraft, the requirements of 14 CFR part 21, subpart D, apply to UA for changes to type certificates. The FAA is developing procedures for processing type design changes for UA type certificated using durability and reliability testing.

Comment Summary: EASA requested the FAA clarify whether the proposed testing criteria would require the applicant to demonstrate aspects that do not occur during a successful flight, such as the deployment of emergency recovery systems and fire protection/post-crash fire. EASA asked if these aspects are addressed by other means and what would be the applicable airworthiness criteria.

FAA Response: Equipment not required for normal operation of the UA do not require an evaluation for their specific functionality. D&R testing will show that the inclusion of any such equipment does not prevent normal operation. Therefore, the airworthiness criteria would not require functional testing of the systems described by EASA.

Comment Summary: An individual commenter requested the FAA specify the acceptable percentage of failures in the testing that would result in a “loss of flight.” The Small UAV Coalition requested the FAA clarify what constitutes an emergency landing outside an operator's landing area, as some UAS designs could include an onboard health system that initiates a landing to lessen the potential of a loss of control event. The commenter suggested that, in those cases, a landing in a safe location should not invalidate the test.

FAA Response: The airworthiness criteria require that all test points and flight hours occur with no failures result in a loss of flight, control, containment, or emergency landing outside the operator's recovery zone. The FAA has determined that there is no acceptable percentage of failures in testing. In addition, while the recovery zone may differ for each UAS design, an emergency or unplanned landing outside of a designated landing area would result in a test failure.

Comment Summary: The Small UAV Coalition requested that a single failure during testing not automatically restart counting the number of flight test operations set for a particular population density; rather, the applicant should have the option to identify the failure through root-cause and fault-tree analysis and provide a validated mitigation to ensure it will not recur. An individual commenter requested the FAA to clarify whether the purpose of the tests is to show compliance with a quantitative safety objective. The commenter further requested the FAA allow the applicant to reduce the number of flight testing hours if the applicant can present a predicted safety and reliability analysis.

FAA Response: The intent of the testing criteria is for the applicant to demonstrate the aircraft's durability and reliability through a successful accumulation of flight testing hours. The FAA does not intend to require analytical evaluation to be part of this process. However, the applicant will comply with these testing criteria using a means of compliance, accepted by the FAA, through the issue paper process. The means of compliance will be dependent on the CONOPS the applicant has proposed to meet.

The FAA proposed criteria to evaluate how the UAS functions after probable failures, including failures related to propulsion systems, C2 link, GPS, critical flight control components with a single point of failure, control station, and any other equipment identified by the applicant.

Comment Summary: Droneport Texas LLC requested the FAA add a bird strike to the list of probable failures. The commenter stated that despite sense and avoid technologies, flocks of birds can overcome the maneuver capabilities of a UA and result in multiple, unintended failures.

FAA Response: Unlike manned aircraft, where aircraft size, design, and construct are critical to safe control of the aircraft after encountering a bird strike, the FAA determined testing for bird strike capabilities is not necessary for the Model 198 US UA. The FAA has determined that a bird strike requirement is not necessary because the smaller size and lower operational speed of the 198 US reduce the likelihood of a bird strike, combined with the reduced consequences of failure due to no persons onboard. Instead, the FAA is using a risk-based approach to tailor airworthiness requirements commensurate to the low-risk nature of the Model 198 US UA.

Comment Summary: ALPA requested the FAA require that all probable failure tests occur at the critical phase and mode of flight and at the highest aircraft-to-pilot ratio. ALPA stated the proposed criteria are critically important for systems that rely on a single source to perform multi-label functions, such as GNSS, because failure or interruption of GNSS will lead to loss of positioning, navigation, and timing (PNT) and functions solely dependent on PNT, such as geo-fencing and contingency planning.

FAA Response: No change is necessary because D&R.300(c) requires that the testing occur at the critical phase and mode of flight and at the highest UA-to-pilot ratio.

Comment Summary: Droneport Texas LLC requested the FAA add recovery from vortex ring state (VRS) to the list of probable failures. The commenter stated the UA uses multiple rotors for lift and is therefore susceptible to VRS. The commenter further stated that because recovery from settling with power is beyond a pilot's average skill for purposes of airworthiness testing, the aircraft must be able to sense and recover from this condition without pilot assistance.

FAA Response: D&R.305 addresses probable failures related to specific components of the UAS. VRS is an aerodynamic condition a UA may encounter during flight testing; it is not a component subject to failure.

Comment Summary: Droneport Texas LLC also requested the FAA add a response to the Air Traffic Control-Zero (ATC-Zero) command to the list of probable failures. The commenter stated, based on lessons learned after the attacks on September 11, 2001, aircraft that can fly BVLOS should be able to respond to an ATC-Zero condition.

FAA Response: The commenter's request is more appropriate for the capabilities and functions testing criteria in D&R.310 than probable failures testing in D&R.305. D&R.310(a)(3) requires the applicant to demonstrate by test that the pilot has the ability to safely discontinue a flight. A pilot may discontinue a flight for a wide variety of reasons, including responding to an ATC-zero command.

Comment Summary: EASA stated the proposed language seems to require an additional analysis and safety assessment, which would be appropriate for the objective requirement of ensuring a probable failure does not result in a loss of containment or control. EASA further stated that an applicant's basic understanding of the systems architecture and effects of failures is essential.

FAA Response: The FAA agrees with the expectation that applicants understand the system architecture and effects of failures of a proposed design, which is why the criteria include a requirement for the applicant to test the specific equipment identified in D&R.305 and identify any other equipment that is not specifically identified in D&R.305 for testing. As the intent of the criteria is for the applicant to demonstrate compliance through testing, some analysis may be necessary to properly identify the appropriate equipment to be evaluated for probable failures.

Comment Summary: An individual requested that probable failure testing apply not only to critical flight control components with a single point of failure, but also to any critical part with a single point of failure.

FAA Response: The purpose of probable failure testing in D&R.305 is to demonstrate that if certain equipment fails, it will fail safely. Adding probable failure testing for critical (now flight essential) parts would not add value to testing. If a part is essential for flight, its failure by definition in D&R.135(a) could result in a loss of flight or unrecoverable loss of control. For example, on a traditional airplane design, failure of a wing spar in flight would lead to loss of the aircraft. Because there is no way to show that a wing spar can fail safely, the applicant must provide its mandatory replacement time if applicable, structural inspection interval, and related structural inspection procedure in the Airworthiness Limitations section of the ICA. Similarly, under these airworthiness criteria, parts whose failure would inherently result in loss of flight or unrecoverable loss of control are not subjected to probable failure testing. Instead, they must be identified as flight essential components and included in the ICA.

To avoid confusion pertaining to probable failure testing, the FAA has removed the word “critical” from D&R.305(a)(5). In the final airworthiness criteria, probable failure testing required by D&R.305(a)(5) applies to “Flight control components with a single point of failure.”

The FAA proposed criteria to require the applicant to demonstrate by test the minimum capabilities and functions necessary for the design. UAS.310(a) proposed to require the applicant to demonstrate, by test, the capability of the UAS to regain command and control of the UA after a C2 link loss, the sufficiency of the electrical system to carry all anticipated loads, and the ability of the pilot to override any pre-programming in order to resolve a potential unsafe operating condition in any phase of flight. UAS.310(b) proposed to require the applicant to demonstrate by test certain features if the applicant requests approval of those features (geo-fencing, external cargo, etc.). UAS.310(c) proposed to require the design of the UAS to safeguard against an unintended discontinuation of flight or release of cargo, whether by human action or malfunction.

Comment Summary: ALPA stated the pilot-in-command must always have the capability to input control changes to the UA and override any pre-programming without delay as needed for the safe management of the flight. The commenter requested that the FAA retain the proposed criteria that would allow the pilot to command to: Regain command and control of the UA after loss of the C2 link; safely discontinue the flight; and dynamically re-route the UA. In support, ALPA stated the ability of the pilot to continually command (re-route) the UA, including termination of the flight if necessary, is critical for safe operations and should always be available to the pilot.

Honeywell requested the FAA revise paragraphs (a)(3) and (a)(4) of the criteria (UAS.310) to allow for either the pilot or an augmenting system to safely discontinue the flight and re-route the UA. The commenter stated that a system comprised of detect and avoid, onboard autonomy, and ground system can be used for these functions. Therefore, the criteria should not require that only the pilot can do them.

An individual commenter requested the FAA remove UAS.310(a)(4) of the proposed criteria because requiring the ability for the pilot to dynamically re-route the UA is too prescriptive and redundant with the proposed requirement in UAS.310(a)(3), the ability of the pilot to discontinue the flight safely.

FAA Response: Because the pilot in command is directly responsible for the operation of the UA, the pilot must have the capability to command actions necessary for continued safety. This includes commanding a change to the flight path or, when appropriate, safely terminating a flight. The FAA notes that the ability for the pilot to safely discontinue a flight means the pilot has the means to terminate the flight and immediately and safely return the UA to the ground. This is different from the pilot having the means to dynamically re-route the UA, without terminating the flight, to avoid a conflict.

Therefore, the final airworthiness criteria include D&R.310(a) as proposed (UAS.310(a)).

Comment Summary: ALPA requested the FAA revise the criteria to require that all equipment, systems, and installations conform, at a minimum, to the standards of § 25.1309.

FAA Response: The FAA determined that traditional methodologies for manned aircraft, including the system safety analysis required by § 23.2510, § 25.1309, § 27.1309, or § 29.1309, would be inappropriate to require for the Wingcopter Model 198 US due to its smaller size and reduced level of complexity. Instead, the FAA finds that system reliability through testing will ensure the safety of this design.

Comment Summary: ALPA requested the FAA revise the criteria to add a requirement to demonstrate the ability of the UA and pilot to perform all of the contingency plans identified in proposed UAS.120.

FAA Response: No change is necessary because D&R.120 and D&R.305(a)(2), together, require what ALPA requests in its comment. Under D&R.120, the applicant must design the UA to execute a predetermined action in the event of a loss of the C2 link. D&R.305(a)(2) requires the applicant to demonstrate by test that a lost C2 link will not result in a loss of containment or control of the UA. Thus, if the applicant does not demonstrate the predetermined contingency plan resulting from a loss of the C2 link when conducting D&R.305 testing, the test would be a failure due to loss of containment.

Comment Summary: ALPA and an individual commenter requested the FAA revise the criteria so that geo-fencing is a required feature and not optional due to the safety concerns that could result from a UA exiting its operating area.

FAA Response: To ensure safe flight, the applicant must test the proposed safety functions, such as geo-fencing, that are part of the type design of the Model 198 US UA. The FAA determined that geo-fencing is an optional feature because it is one way, but not the only way, to ensure a safely contained operation.

Comment Summary: ALPA requested the FAA revise the criteria so that capability to detect and avoid other aircraft and obstacles is a required feature and not optional.

FAA Response: D&R.310(a)(4) requires the applicant demonstrate the ability for the pilot to safely re-route the UA in flight to avoid a dynamic hazard. The FAA did not prescribe specific design features such as a collision avoidance system to meet D&R.310(a)(4) because there are multiple means to minimize the risk of collision.

Comment Summary: McMahon Helicopter Services requested that the airworthiness criteria require a demonstration of sense-and-avoid technology that will automatically steer the UA away from manned aircraft, regardless of whether the manned aircraft has a transponder. NAAA and an individual commenter requested that the FAA require ADS-B in/out and traffic avoidance software on all UAS. The Small UAV Coalition requested the FAA establish standards for collision avoidance technology, as the proposed criteria are not sufficient for compliance with the operational requirement to see and avoid other aircraft (§ 91.113). The commenters stated that these technologies are necessary to avoid a mid-air collision between UA and manned aircraft.

FAA Response: D&R.310(a)(4) requires the applicant demonstrate the ability for the UA to be safely re-routed in flight to avoid a dynamic hazard. The FAA did not prescribe specific design features, such as the technologies suggested by the commenters, to meet D&R.310(a)(4) because they are not the only means for complying with the operational requirement to see and avoid other aircraft. If an applicant chooses to equip their UA with onboard collision avoidance technology, those capabilities and functions must be demonstrated by test per D&R.310(b)(5).

The FAA proposed to require an evaluation of the UA's performance, maneuverability, stability, and control with a factor of safety.

Comment Summary: EASA requested that the FAA revise its approach to require a similar compliance demonstration as EASA's for “light UAS.” EASA stated the FAA's proposed criteria for verification of limits, combined with the proposed Flight Manual requirements, seem to replace a traditional Subpart Flight. 3 EASA further stated the FAA's approach in the proposed airworthiness criteria might necessitate more guidance and means of compliance than the traditional structure.

FAA Response: The FAA's airworthiness criteria will vary from EASA's light UAS certification requirements, resulting in associated differences in compliance demonstrations. At this time, comment on means of compliance and related guidance material, which are still under development with the FAA and with EASA, would be speculative.

Comment Summary: ALPA requested the FAA conduct an analysis to determine battery reliability and safety, taking into account wind and weather conditions and their effect on battery life. ALPA expressed concern with batteries as the only source of power for an aircraft in the NAS. ALPA further requested the FAA not grant exemptions for battery reserve requirements.

FAA Response: Because batteries are a flight essential part, the applicant must establish mandatory instructions or life limits for batteries under the requirements of D&R.135. In addition, when the applicant conducts its D&R testing, D&R.300(i) prevents the applicant from exceeding the maintenance intervals or life limits for those batteries. To the extent the commenter's request addresses fuel reserves, that is an operational requirement, not a certification requirement, and therefore beyond the scope of this document.

Comment Summary: McMahon Helicopter Services requested that the criteria require anti-collision and navigation lighting certified to existing FAA standards for brightness and size. The commenter stated that these standards were based on human factors for nighttime and daytime recognition and are not simply a lighting requirement. An individual commenter requested that the criteria include a requirement for position lighting and anti-collision beacons meeting TSO-30c Level III. NAAA requested the criteria require a strobe light and high visibility paint scheme to aid in visual detection of the UA by other aircraft.

FAA Response: The FAA determined it is unnecessary for these airworthiness criteria to prescribe specific design features for anti-collision or navigation lighting. The FAA will address anti-collision lighting as part of any operational approval, similar to the rules in 14 CFR 107.29(a)(2) and (b) for small UAS.

Comment Summary: ALPA requested the FAA add a new section with minimum standards for Global Navigation Satellite System (GNSS), as the UAS will likely rely heavily upon GNSS for navigation and to ensure that the UA does not stray outside of its approved airspace. ALPA stated that technological advances have made such devices available at an appropriate size, weight, and power for UAs.

FAA Response: The airworthiness criteria in D&R.100 (UA Signal Monitoring and Transmission), D&R.110 (Software), D&R.115 (Cybersecurity), and D&R.305(a)(3) (probable failures related to GPS) sufficiently address design requirements and testing of navigation systems. Even if the applicant uses a TSO-approved GNSS, these airworthiness criteria require a demonstration that the UA operates successfully without loss of containment. Successful completion of these tests demonstrates that the navigation subsystems are acceptable.

Comment Summary: ALPA requested the FAA revise the criteria to add a new section requiring equipage to comply with the FAA's new rules on Remote Identification of Unmanned Aircraft (86 FR 4390, Jan. 15, 2021). An individual commenter questioned the need for public tracking and identification of drones in the event of a crash or violation of FAA flight rules.

FAA Response: The FAA issued the final rule, Remote Identification of Unmanned Aircraft, after providing an opportunity for public notice and comment. The final rule is codified at 14 CFR part 89. Part 89 contains the remote identification requirements for unmanned aircraft certificated and produced under part 21 after September 16, 2022.

Comment Summary: ALPA, NAAA, and one individual questioned the safety of multiple Model 198 US UA operated by a single pilot, up to a ratio of 20 UA to 1 pilot. ALPA stated that even with high levels of automation, the pilot must still manage the safe operation and maintain situational awareness of multiple aircraft in their flight path, aircraft systems, integration with traffic, obstacles, and other hazards during normal, abnormal, and emergency conditions. As a result, ALPA recommended the FAA conduct additional studies to better understand the feasibility of a single pilot operating multiple UA before developing airworthiness criteria. The Small UAV Coalition requested the FAA provide criteria for an aircraft-to-pilot ratio higher than 20:1.

FAA Response: These airworthiness criteria are specific to the Model 198 US UA and, as discussed previously in this preamble, operations of the Model 198 US UA may include multiple UA operated by a single pilot, up to a ratio of 20 UA to 1 pilot. Additionally, these airworthiness criteria require the applicant to demonstrate the durability and reliability of the UA design by flight test, at the highest aircraft-to-pilot ratio, without exceptional piloting skill or alertness. In addition, D&R.305(c) requires the applicant to demonstrate probable failures by test at the highest aircraft-to-pilot ratio. Should the pilot ratio cause a loss of containment or control of the UA, then the applicant will fail this testing.

Comment Summary: ALPA stated that to allow a UAS-pilot ratio of up to 20:1 safely, the possibility that the pilot will need to intervene with multiple UA simultaneously must be “extremely remote.” ALPA questioned whether this is feasible given the threat of GNSS interference or unanticipated wind gusts exceeding operational limits.

FAA Response: The FAA's guidance in AC 23.1309-1E, System Safety Analysis and Assessment for Part 23 Airplanes defines “extremely remote failure conditions” as failure conditions not anticipated to occur during the total life of an airplane, but which may occur a few times when considering the total operational life of all airplanes of the same type. When assessing the likelihood of a pilot needing to intervene with multiple UA simultaneously, the minimum reliability requirements will be determined based on the applicant's proposed CONOPS.

Comment Summary: An individual commenter expressed concern about noise pollution.

FAA Response: The Model 198 US will need to comply with FAA noise certification standards. If the FAA determines that 14 CFR part 36 does not contain adequate standards for this design, the agency will propose and seek public comment on a rule of particular applicability for noise requirements under a separate rulemaking docket.

Comment Summary: ALPA, McMahon Helicopter Services, and NAAA commented on the operation of UAS at or below 400 feet AGL. ALPA, McMahon Helicopter Services, and NAAA requested the airworthiness criteria contain measures for safe operation at low altitudes so that UAS are not a hazard to manned aircraft, especially operations involving helicopters; air tours; agricultural applications; emergency medical services; air tanker firefighting; power line and pipeline patrol and maintenance; fish and wildlife service; animal control; military and law enforcement; seismic operations; ranching and livestock relocation; and mapping.

FAA Response: The type certificate only establishes the approved design of the UA. These airworthiness criteria require the applicant show compliance for the UA altitude sought for type certification. While this may result in operating limitations in the flight manual, the type certificate is not an approval for operations. Operations and operational requirements are beyond the scope of this document.

Comment Summary: NUAIR requested the FAA complete and publish its draft AC 21.17-XX, Type Certification Basis for Unmanned Aircraft Systems (UAS), to provide additional guidance, including templates, to those who seek a type design approval for UAS. NUAIR also requested the FAA recognize the industry consensus-based standards applicable to UAS, as Transport Canada has by publishing its AC 922-001, Remotely Piloted Aircraft Systems Safety Assurance.

FAA Response: The FAA will continue to develop policy and guidance for UA type certification and will publish guidance as soon as practicable. The FAA encourages consensus standards bodies to develop means of compliance and submit them to the FAA for acceptance. Regarding Transport Canada AC 922-001, that AC addresses operational approval rather than type certification.

Comment Summary: ALPA requested the FAA ensure that operations, including UA integrity, fall under the safety management system. ALPA further requested the FAA convene a Safety Risk Management Panel before allowing operators to commence operations and that the FAA require operators to have an active safety management system, including a non-punitive safety culture, where incident and continuing airworthiness issues can be reported.

FAA Response: The type certificate only establishes the approved design of the UA, including the Flight Manual and ICA. Operations and operational requirements, including safety management and oversight of operations and maintenance, are beyond the scope of this document.

Comment Summary: ALPA supported the FAA's type certification of UAS as a “special class” of aircraft under § 21.17(b) but requested that it be temporary.

FAA Response: As the FAA stated in its notice of policy issued August 11, 2020 (85 FR 58251, September 18, 2020), the FAA will use the type certification process under § 21.17(b) for some unmanned aircraft with no occupants onboard. The FAA further stated in its policy that it may also issue type certificates under § 21.17(a) for airplane and rotorcraft UAS designs where the airworthiness standards in part 23, 25, 27, or 29, respectively, are appropriate. The FAA, in the future, may consider establishing appropriate generally applicable airworthiness standards for UA that are not certificated under the existing standards in part 23, 25, 27, or 29.

The FAA received and reviewed several comments that were general, stated the commenter's viewpoint or opposition without a suggestion specific to the proposed criteria, or did not make a request the FAA can act on. These comments are beyond the scope of this document.

These airworthiness criteria, established under the provisions of § 21.17(b), are applicable to the Wingcopter Model 198 US UA. Should Wingcopter wish to apply these airworthiness criteria to other UA models, it must submit a new type certification application.

This action affects only certain airworthiness criteria for the Wingcopter Model 198 US UA. It is not a standard of general applicability.

The authority citation for these airworthiness criteria is as follows:

Pursuant to the authority delegated to me by the Administrator, the following airworthiness criteria are issued as part of the type certification basis for the Wingcopter Model 198 US unmanned aircraft. The FAA finds that compliance with these criteria appropriately mitigates the risks associated with the design and concept of operations and provides an equivalent level of safety to existing rules.

The applicant must define and submit to the FAA a concept of operations (CONOPS) proposal describing the unmanned aircraft system (UAS) operation in the national airspace system for which unmanned aircraft (UA) type certification is requested. The CONOPS proposal must include, at a minimum, a description of the following information in sufficient detail to determine the parameters and extent of testing and operating limitations:

(a) The intended type of operations;

(b) UA specifications;

(c) Meteorological conditions;

(d) Operators, pilots, and personnel responsibilities;

(e) Control station, support equipment, and other associated elements (AE) necessary to meet the airworthiness criteria;

(f) Command, control, and communication functions;

(g) Operational parameters (such as population density, geographic operating boundaries, airspace classes, launch and recovery area, congestion of proposed operating area, communications with air traffic control, line of sight, and aircraft separation); and

(h) Collision avoidance equipment, whether onboard the UA or part of the AE, if requested.

For purposes of these airworthiness criteria, the following definitions apply.

(a) Loss of Control: Loss of control means an unintended departure of an aircraft from controlled flight. It includes control reversal or an undue loss of longitudinal, lateral, and directional stability and control. It also includes an upset or entry into an unscheduled or uncommanded attitude with high potential for uncontrolled impact with terrain. A loss of control means a spin, loss of control authority, loss of aerodynamic stability, divergent flight characteristics, or similar occurrence, which could generally lead to crash.

(b) Loss of Flight: Loss of flight means a UA's inability to complete its flight as planned, up to and through its originally planned landing. It includes scenarios where the UA experiences controlled flight into terrain, obstacles, or any other collision, or a loss of altitude that is severe or non-reversible. Loss of flight also includes deploying a parachute or ballistic recovery system that leads to an unplanned landing outside the operator's designated recovery zone.

The UA must be designed to monitor and transmit to the AE all information required for continued safe flight and operation. This information includes, at a minimum, the following:

(a) Status of all critical parameters for all energy storage systems;

(b) Status of all critical parameters for all propulsion systems;

(c) Flight and navigation information as appropriate, such as airspeed, heading, altitude, and location; and

(d) Communication and navigation signal strength and quality, including contingency information or status.

(a) The applicant must identify and submit to the FAA all AE and interface conditions of the UAS that affect the airworthiness of the UA or are otherwise necessary for the UA to meet these airworthiness criteria. As part of this requirement—

(1) The applicant may identify either specific AE or minimum specifications for the AE.

(i) If minimum specifications are identified, they must include the critical requirements of the AE, including performance, compatibility, function, reliability, interface, pilot alerting, and environmental requirements.

(ii) Critical requirements are those that if not met would impact the ability to operate the UA safely and efficiently.

(2) The applicant may use an interface control drawing, a requirements document, or other reference, titled so that it is clearly designated as AE interfaces to the UA.

(b) The applicant must show the FAA the AE or minimum specifications identified in paragraph (a) of this section meet the following:

(1) The AE provide the functionality, performance, reliability, and information to assure UA airworthiness in conjunction with the rest of the design;

(2) The AE are compatible with the UA capabilities and interfaces;

(3) The AE must monitor and transmit to the pilot all information required for safe flight and operation, including but not limited to those identified in D&R.100; and

(4) The minimum specifications, if identified, are correct, complete, consistent, and verifiable to assure UA airworthiness.

(c) The FAA will establish the approved AE or minimum specifications as operating limitations and include them in the UA type certificate data sheet and Flight Manual.

(d) The applicant must develop any maintenance instructions necessary to address implications from the AE on the airworthiness of the UA. Those instructions will be included in the instructions for continued airworthiness (ICA) required by D&R.205.

To minimize the existence of software errors, the applicant must:

(a) Verify by test all software that may impact the safe operation of the UA;

(b) Utilize a configuration management system that tracks, controls, and preserves changes made to software throughout the entire life cycle; and

(c) Implement a problem reporting system that captures and records defects and modifications to the software.

(a) UA equipment, systems, and networks, addressed separately and in relation to other systems, must be protected from intentional unauthorized electronic interactions that may result in an adverse effect on the security or airworthiness of the UA. Protection must be ensured by showing that the security risks have been identified, assessed, and mitigated as necessary.

(b) When required by paragraph (a) of this section, procedures and instructions to ensure security protections are maintained must be included in the ICA.

(a) The UA must be designed so that, in the event of a loss of the command and control (C2) link, the UA will automatically and immediately execute a safe predetermined flight, loiter, landing, or termination.

(b) The applicant must establish the predetermined action in the event of a loss of the C2 link and include it in the UA Flight Manual.

(c) The UA Flight Manual must include the minimum performance requirements for the C2 data link defining when the C2 link is degraded to a level where remote active control of the UA is no longer ensured. Takeoff when the C2 link is degraded below the minimum link performance requirements must be prevented by design or prohibited by an operating limitation in the UA Flight Manual.

(a) Except as provided in paragraph (b) of this section, the UA must have design characteristics that will protect the UA from loss of flight or loss of control due to lightning.

(b) If the UA has not been shown to protect against lightning, the UA Flight Manual must include an operating limitation to prohibit flight into weather conditions conducive to lightning activity.

(a) For purposes of this section, “adverse weather conditions” means rain, snow, and icing.

(b) Except as provided in paragraph (c) of this section, the UA must have design characteristics that will allow the UA to operate within the adverse weather conditions specified in the CONOPS without loss of flight or loss of control.

(c) For adverse weather conditions for which the UA is not approved to operate, the applicant must develop operating limitations to prohibit flight into known adverse weather conditions and either:

(1) Develop operating limitations to prevent inadvertent flight into adverse weather conditions; or

(2) Provide a means to detect any adverse weather conditions for which the UA is not certificated to operate and show the UA's ability to avoid or exit those conditions.

(a) A flight essential part is a part, the failure of which could result in a loss of flight or unrecoverable loss of UA control.

(b) If the type design includes flight essential parts, the applicant must establish a flight essential parts list. The applicant must develop and define mandatory maintenance instructions or life limits, or a combination of both, to prevent failures of flight essential parts. Each of these mandatory actions must be included in the Airworthiness Limitations Section of the ICA.

The applicant must provide a Flight Manual with each UA.

(a) The UA Flight Manual must contain the following information:

(1) UA operating limitations;

(2) UA operating procedures;

(3) Performance information;

(4) Loading information; and

(5) Other information that is necessary for safe operation because of design, operating, or handling characteristics.

(b) Those portions of the UA Flight Manual containing the information specified in paragraph (a)(1) of this section must be approved by the FAA.

The applicant must prepare ICA for the UA in accordance with Appendix A to Part 23, as appropriate, that are acceptable to the FAA. The ICA may be incomplete at type certification if a program exists to ensure their completion prior to delivery of the first UA or issuance of a standard airworthiness certificate, whichever occurs later.

The UA must be designed to be durable and reliable when operated under the limitations prescribed for its operating environment, as documented in its CONOPS and included as operating limitations on the type certificate data sheet and in the UA Flight Manual. The durability and reliability must be demonstrated by flight test in accordance with the requirements of this section and completed with no failures that result in a loss of flight, loss of control, loss of containment, or emergency landing outside the operator's recovery area.

(a) Once a UA has begun testing to show compliance with this section, all flights for that UA must be included in the flight test report.

(b) Tests must include an evaluation of the entire flight envelope across all phases of operation and must address, at a minimum, the following:

(1) Flight distances;

(2) Flight durations;

(3) Route complexity;

(4) Weight;

(5) Center of gravity;

(6) Density altitude;

(7) Outside air temperature;

(8) Airspeed;

(9) Wind;

(10) Weather;

(11) Operation at night, if requested;

(12) Energy storage system capacity; and

(13) Aircraft to pilot ratio.

(c) Tests must include the most adverse combinations of the conditions and configurations in paragraph (b) of this section.

(d) Tests must show a distribution of the different flight profiles and routes representative of the type of operations identified in the CONOPS.

(e) Tests must be conducted in conditions consistent with the expected environmental conditions identified in the CONOPS, including electromagnetic interference (EMI) and high intensity radiated fields (HIRF).

(f) Tests must not require exceptional piloting skill or alertness.

(g) Any UAS used for testing must be subject to the same worst-case ground handling, shipping, and transportation loads as those allowed in service.

(h) Any UA used for testing must use AE that meet, but do not exceed, the minimum specifications identified under D&R.105. If multiple AE are identified, the applicant must demonstrate each configuration.

(i) Any UAS used for testing must be maintained and operated in accordance with the ICA and UA Flight Manual. No maintenance beyond the intervals established in the ICA will be allowed to show compliance with this section.

(j) If cargo operations or external-load operations are requested, tests must show, throughout the flight envelope and with the cargo or external-load at the most critical combinations of weight and center of gravity, that—

(1) The UA is safely controllable and maneuverable; and

(2) The cargo or external-load are retainable and transportable.

The UA must be designed such that a probable failure will not result in a loss of containment or control of the UA. This must be demonstrated by test.

(a) Probable failures related to the following equipment, at a minimum, must be addressed:

(1) Propulsion systems;

(2) C2 link;

(3) Global Positioning System (GPS);

(4) Flight control components with a single point of failure;

(5) Control station; and

(6) Any other AE identified by the applicant.

(b) Any UA used for testing must be operated in accordance with the UA Flight Manual.

(c) Each test must occur at the critical phase and mode of flight, and at the highest aircraft-to-pilot ratio.

(a) All of the following required UAS capabilities and functions must be demonstrated by test:

(1) Capability to regain command and control of the UA after the C2 link has been lost.

(2) Capability of the electrical system to power all UA systems and payloads.

(3) Ability for the pilot to safely discontinue the flight.

(4) Ability for the pilot to dynamically re-route the UA.

(5) Ability to safely abort a takeoff.

(6) Ability to safely abort a landing and initiate a go-around.

(b) The following UAS capabilities and functions, if requested for approval, must be demonstrated by test:

(1) Continued flight after degradation of the propulsion system.

(2) Geo-fencing that contains the UA within a designated area, in all operating conditions.

(3) Positive transfer of the UA between control stations that ensures only one control station can control the UA at a time.

(4) Capability to release an external cargo load to prevent loss of control of the UA.

(5) Capability to detect and avoid other aircraft and obstacles.

(c) The UA must be designed to safeguard against inadvertent discontinuation of the flight and inadvertent release of cargo or external load.

The structure of the UA must be shown to withstand the repeated loads expected during its service life without failure. A life limit for the airframe must be established, demonstrated by test, and included in the ICA.

The performance, maneuverability, stability, and control of the UA within the flight envelope described in the UA Flight Manual must be demonstrated at a minimum of 5% over maximum gross weight with no loss of control or loss of flight.

Flirtey Inc. (Flirtey) applied to the FAA on November 12, 2018, for a special class type certificate under title 14, Code of Federal Regulations (14 CFR), § 21.17(b) for the Model Flirtey F4.5 UA.

The Model Flirtey F4.5 consists of a rotorcraft UA and its associated elements (AE) including communication links and components that control the UA. The Model Flirtey F4.5 UA has a maximum gross takeoff weight of 38 pounds. It is approximately 78 inches in width, 78 inches in length, and 21 inches in height. The Model Flirtey F4.5 UA uses battery-powered electric motors for vertical takeoff, landing, and forward flight. The UAS operations would rely on high levels of automation and may include multiple UA operated by a single pilot, up to a ratio of 20 UA to 1 pilot. Flirtey anticipates operators will use the Model Flirtey F4.5 for delivering medical supplies and packages. The proposed concept of operations (CONOPS) for the Model Flirtey F4.5 identifies a maximum operating altitude of 400 feet above ground level (AGL), a maximum cruise speed of 24 knots, operations beyond visual line of sight (BVLOS) of the pilot, and operations over human beings. Flirtey has not requested type certification for flight into known icing for the Model Flirtey F4.5.

The FAA issued a notice of proposed airworthiness criteria for the Flirtey F4.5 UAS, which published in the Federal Register on November 24, 2020 (85 FR 74922).

Based on the comments received, these final airworthiness criteria reflect the following changes, as explained in more detail under Discussion of Comments: A new section containing definitions; revisions to the CONOPS requirement; changing the term “critical part” to “flight essential part” in D&R.135; changing the basis of the durability and reliability testing from population density to limitations prescribed for the operating environment identified in the applicant's CONOPS per D&R.001; and, for the demonstration of certain required capabilities and functions as required by D&R.310.

Additionally, the FAA re-evaluated its approach to type certification of low-risk UA using durability and reliability testing. Safe UAS operations depend and rely on both the UA and the AE. As explained in FAA Memorandum AIR600-21-AIR-600-PM01, dated July 13, 2021, the FAA has revised the airworthiness criteria to define a boundary between the UA type certification and subsequent operational evaluations and approval processes for the UAS ( i.e., waivers, exemptions, and/or operating certificates).

To reflect that these airworthiness criteria rely on durability and reliability (D&R) testing for certification, the FAA changed the prefix of each section from “UAS” to “D&R.”

Lastly, the FAA revised D&R.001(g) to clarify that the operational parameters listed in that paragraph are examples and not an all-inclusive list.

The FAA received responses from 14 commenters. The majority of the commenters were individuals. In addition to the individuals' comments, the FAA also received comments from the European Union Aviation Safety Agency (EASA), unmanned aircraft manufacturers, a helicopter operator, and organizations such as the Air Line Pilots Association (ALPA), Droneport Texas, LLC, the National Agricultural Aviation Association (NAAA), Northeast UAS Airspace Integration Research Alliance, Inc. (NUAIR), and the Small UAV Coalition.

Comment Summary: ALPA, NUAIR, and the Small UAV Coalition expressed support for type certification as a special class of aircraft and establishing airworthiness criteria under § 21.17(b). The Small UAV Coalition also supported the FAA's proposed use of performance-based standards.

Comment Summary: An individual commenter requested the FAA define the term “loss of flight” and clarify how it is different from “loss of control.” The commenter questioned whether loss of flight meant the UA could not continue its intended flight plan but could safely land or terminate the flight.

FAA Response: The FAA has added a new section, D&R.005, to define the terms “loss of flight” and “loss of control” for the purposes of these airworthiness criteria. “Loss of flight” refers to a UA's inability to complete its flight as planned, up to and through its originally planned landing. “Loss of flight” includes scenarios where the UA experiences controlled flight into terrain or obstacles, or any other collision, or a loss of altitude that is severe or non-recoverable. “Loss of flight” includes deploying a parachute or ballistic recovery system that leads to an unplanned landing outside the operator's designated recovery zone.

“Loss of control” means an unintended departure of an aircraft from controlled flight. It includes control reversal or an undue loss of longitudinal, lateral, and directional stability and control. It also includes an upset or entry into an unscheduled or uncommanded attitude with high potential for uncontrolled impact with terrain. “Loss of control” means a spin, loss of control authority, loss of aerodynamic stability, divergent flight characteristic, or similar occurrence, which could generally lead to a crash.

Comment Summary: Two commenters requested the FAA clarify terminology with respect to piloting skill and alertness. Droneport Texas LLC stated that the average pilot skill and alertness is currently undefined, as remote pilots do not undergo oral or practical examinations to obtain certification. NUAIR noted that, despite the definition of “exceptional piloting skill and alertness” in Advisory Circular (AC) 23-8C, Flight Test Guide for Certification of Part 23 Airplanes, there is a significant difference between the average skill and alertness of a remote pilot certified under 14 CFR part 107 and a pilot certified under 14 CFR part 61. The commenter requested the FAA clarify the minimum qualifications and ratings to perform as a remote pilot of a UAS with a type certificate.

FAA Response: These airworthiness criteria do not require exceptional piloting skill and alertness for testing. The FAA included this as a requirement to ensure the applicant passes testing by using pilots of average skill who have been certificated under part 61, as opposed to highly trained pilots with thousands of hours of flight experience.

The FAA proposed a requirement for the applicant to submit a CONOPS describing the UAS and identifying the intended operational concepts. The FAA explained in the preamble of the notice of proposed airworthiness criteria that the information in the CONOPS would determine parameters for testing and flight manual operating limitations.

Comment Summary: One commenter stated that the airworthiness criteria are generic and requested the FAA add language to proposed UAS.001 to clarify that some of the criteria may not be relevant or necessary.

FAA Response: Including the language requested by the commenter would be inappropriate, as these airworthiness criteria are project-specific. Thus, in this case, each element of these airworthiness criteria is a requirement specific to the type certification of Flirtey's proposed UA design.

Comment Summary: ALPA requested the criteria specify that the applicant's CONOPS contain sufficient detail to determine the parameters and extent of testing, as well as operating limitations placed on the UAS for its operational uses.

FAA Response: The FAA agrees and has updated D&R.001 to clarify that the information required for inclusion in the CONOPS proposal (D&R.001(a) through (g)) must be described in sufficient detail to determine the parameters and extent of testing and operating limitations.

Comment Summary: ALPA requested the CONOPS include a description of a means to ensure separation from other aircraft and perform collision avoidance maneuvers. ALPA stated that its requested addition to the CONOPS is critical to the safety of other airspace users, as manned aircraft do not easily see most UAs.

FAA Response: The FAA agrees and has updated D&R.001 to require that the applicant identify collision avoidance equipment (whether onboard the UA or part of the AE), if the applicant requests to include that equipment.

Comment Summary: ALPA requested the FAA add security-related (other than cyber-security) requirements to the CONOPS criteria, including mandatory reporting of security occurrences, security training and awareness programs for all personnel involved in UAS operations, and security standards for the transportation of goods, similar to those for manned aviation.

FAA Response: The type certificate only establishes the approved design of the UA. Operations and operational requirements, including those regarding security occurrences, security training, and package delivery security standards (other than cybersecurity airworthiness design requirements) are beyond the scope of the airworthiness criteria established by this document and are not required for type certification.

Comment Summary: UAS.001(c) proposed to require that the applicant's CONOPS include a description of meteorological conditions. ALPA requested the FAA change UAS.001(c) to require a description of meteorological and environmental conditions and their operational limits. ALPA stated the CONOPS should include maximum wind speeds, maximum or minimum temperatures, maximum density altitudes, and other relevant phenomena that will limit operations or cause operations to terminate.

FAA Response: D&R.001(c) and D&R.125 address meteorological conditions, while D&R.001(g) addresses environmental considerations. The FAA determined that these criteria are sufficient to cover the weather phenomena mentioned by the commenter without specifically requiring identification of related operational limits.

To address the risks associated with loss of control of the UA, the FAA proposed that the applicant design the control station to provide the pilot with all information necessary for continued safe flight and operation.

Comment Summary: ALPA and one individual commenter requested the FAA revise the proposed criteria to add requirements for the control station. Specifically, these commenters requested the FAA include the display of data and alert conditions to the pilot, physical security requirements for both the control station and the UAS storage area, design requirements that minimize negative impact of extended periods of low pilot workload, transfer of control between pilots, and human factors/human machine interface considerations for handheld controls. NUAIR requested the FAA designate the control station as a flight critical component for operations.

EASA and an individual commenter requested the FAA consider flexibility in some of the proposed criteria. EASA stated that the list of information in proposed UAS.100 is too prescriptive and contains information that may not be relevant for highly automated systems. The individual commenter requested that the FAA allow part-time or non-continuous displays of required information that do not influence the safety of the flight.

FAA Response: Although the scope of the proposed airworthiness criteria applied to the entire UAS, the FAA has re-evaluated its approach to type certification of low-risk unmanned aircraft using durability and reliability testing. A UA is an aircraft that is operated without the possibility of direct human intervention from within or on the aircraft. 1 A UAS is defined as a UA and its AE, including communication links and the components that control the UA, that are required to operate the UAS safely and efficiently in the national airspace system. 2 As explained in FAA Memorandum AIR600-21-AIR-600-PM01, dated July 13, 2021, the FAA determined it will apply the regulations for type design approval, production approval, conformity, certificates of airworthiness, and maintenance to only the UA and not to the AE. However, because safe UAS operations depend and rely on both the UA and the AE, the FAA will consider the AE in assessing whether the UA meets the airworthiness criteria that comprise the certification basis.

While the AE items themselves will be outside the scope of the UA type design, the applicant will provide sufficient specifications for any aspect of the AE, including the control station, which could affect airworthiness. The FAA will approve either the specific AE or minimum specifications for the AE, as identified by the applicant, as part of the type certificate by including them as an operating limitation in the type certificate data sheet and flight manual. The FAA may impose additional operating limitations specific to the AE through conditions and limitations for inclusion in the operational approval ( i.e., waivers, exemptions, or a combination of these). In accordance with this approach, the FAA will consider the entirety of the UAS for operational approval and oversight.

Accordingly, the FAA has revised the criteria by replacing proposed section UAS.100, applicable to the control station design, with D&R.100, UA Signal Monitoring and Transmission, with substantively similar criteria that apply to the UA design.

The FAA has also added a new section, D&R.105, UAS AE Required for Safe UA Operations, which requires the applicant to provide information concerning the specifications of the AE. The FAA has moved the alert function requirement proposed in UAS.100(a) to new section D&R.105(a)(1)(i). As part of the clarification of the testing of the interaction between the UA and AE, the FAA has added a requirement to D&R.300(h) for D&R testing to use minimum specification AE. This addition requires the applicant to demonstrate that the limits proposed for those AE will allow the UA to operate as expected throughout its service life. Finally, the FAA has revised references throughout the airworthiness criteria from “UAS” to “UA,” as appropriate, to reflect the FAA determination that the regulations for type design approval, production approval, conformity, certificates of airworthiness, and maintenance apply to only the UA.

The FAA proposed criteria on verification, configuration management, and problem reporting to minimize the existence of errors associated with UAS software.

Comment Summary: ALPA requested the FAA add language to the proposed criteria to ensure that some level of software engineering principles are used without being too prescriptive.

FAA Response: By combining the software testing requirement of D&R.110(a) with successful completion of the requirements in the entire “Testing” subpart, the acceptable level of software assurance will be identified and demonstrated. The configuration management system required by D&R.110(b) will ensure that the software is adequately documented and traceable both during and after the initial type certification activities.

Comment Summary: EASA suggested the criteria require that the applicant establish and correctly implement system requirements or a structured software development process for critical software.

FAA Response: Direct and specific evaluation of the software development process is more detailed than what the FAA intended with the proposed criteria, which use D&R testing to evaluate the UAS as a whole system, rather than evaluating individual components within the UA. Successful completion of the testing requirements provides confidence that the components that make up the UA provide an acceptable level of safety, commensurate to the low-risk nature of this aircraft. The FAA finds no change to the airworthiness criteria is needed.

Comment Summary: Two individual commenters requested the FAA require the manned aircraft software certification methodology in RTCA DO-178C, Software Considerations in Airborne Systems and Equipment Certification, for critical UA software.

FAA Response: Under these airworthiness criteria, only software that may affect the safe operation of the UA must be verified by test. To verify by test, the applicant will need to provide an assessment showing that other software is not subject to testing because it has no impact on the safe operation of the UA. For software that is subject to testing, the FAA may accept multiple options for software qualification, including DO-178C. Further, specifying that applicants must comply with DO-178 would be inconsistent with the FAA's intent to issue performance-based airworthiness criteria.

Comment Summary: NAAA stated that an overreliance of software in aircraft has been and continues to be a source of accidents and requested the FAA include criteria to prevent a midair collision.

FAA Response: The proper functioning of software is an important element of type certification, particularly with respect to flight controls and navigation. The airworthiness criteria in D&R.110 are meant to provide an acceptable level of safety commensurate with the risk posed by this UA. Additionally, the airworthiness criteria require contingency planning per D&R.120 and the demonstration of the UA's ability to detect and avoid other aircraft in D&R.310, if requested by the applicant. The risk of a midair collision will be minimized by the operating limitations that result from testing based on the operational parameters identified by the applicant in its CONOPS (such as geographic operating boundaries, airspace classes, and congestion of the proposed operating area), rather than by specific mitigations built into the aircraft design itself. These criteria are sufficient due to the low-risk nature of the Model Flirtey F4.5.

Because the UA requires a continuous wireless connection, the FAA proposed criteria to address the risks to the UAS from cybersecurity threats.

Comment Summary: ALPA requested adding a requirement for cybersecurity protection for navigation and position reporting systems such as Global Navigation Satellite System (GNSS). ALPA further requested the FAA include criteria to address specific cybersecurity vulnerabilities, such as jamming (denial of signal) and spoofing (false position data is inserted). ALPA stated that, for navigation, UAS primarily use GNSS—an unencrypted, open-source, low power transmission that can be jammed, spoofed, or otherwise manipulated.

FAA Response: The FAA will assess elements directly influencing the UA for cybersecurity under D&R.115 and will assess the AE as part of any operational approvals an operator may seek. D&R.115 (proposed as UAS.115) addresses intentional unauthorized electronic interactions, which includes, but is not limited to, hacking, jamming, and spoofing. These airworthiness criteria require the high-level outcome the UA must meet, rather than discretely identifying every aspect of cybersecurity the applicant will address.

The FAA proposed criteria requiring that the UAS be designed to automatically execute a predetermined action in the event of a loss of communication between the pilot and the UA. The FAA further proposed that the predetermined action be identified in the Flight Manual and that the UA be precluded from taking off when the quality of service is inadequate.

Comment Summary: ALPA requested the criteria encompass more than loss or degradation of the command and control (C2) link, as numerous types of critical part or systems failures can occur that include degraded capabilities, whether intermittent or sustained. ALPA requested the FAA add language to the proposed criteria to address specific failures such as loss of a primary navigation sensor, degradation or loss of navigation capability, and simultaneous impact of C2 and navigation links.

FAA Response: The airworthiness criteria address the issues raised by ALPA. Specifically, D&R.120(a) addresses actions the UA will automatically and immediately take when the operator no longer has control of the UA. Should the specific failures identified by ALPA result in the operator's loss of control, then the criteria require the UA to execute a predetermined action. Degraded navigation performance does not raise the same level of concern as a degraded or lost C2 link. For example, a UA may experience interference with a GPS signal on the ground, but then find acceptable signal strength when above a tree line or other obstruction. The airworthiness criteria require that neither degradation nor complete loss of GPS or C2, as either condition would be a failure of that system, result in unsafe loss of control or containment. The applicant must demonstrate this by test to meet the requirements of D&R.305(a)(3).

Under the airworthiness criteria, the minimum performance requirements for the C2 link, defining when the link is degraded to an unacceptable level, may vary among different UAS designs. The level of degradation that triggers a loss is dependent upon the specific UA characteristics; this level will be defined by the applicant and demonstrated to be acceptable by testing as required by D&R.305(a)(2) and D&R.310(a)(1).

Comment Summary: An individual commenter requested the FAA use distinct terminology for “communication,” used for communications with air traffic control, and “C2 link,” used for command and control between the remote pilot station and UA. The commenter questioned whether, in the proposed criteria, the FAA stated “loss of communication between the pilot and the UA” when it intended to state “loss of C2 link.”

FAA Response: Communication extends beyond the C2 link and specific control inputs. This is why D&R.001 requires the applicant's CONOPS to include a description of the command, control, and communications functions. As long as the UA operates safely and predictably per its lost link contingency programming logic, a C2 interruption does not constitute a loss of control.

The FAA proposed criteria to address the risks that would result from a lightning strike, accounting for the size and physical limitations of a UAS that could preclude traditional lightning protection features. The FAA further proposed that without lightning protection for the UA, the Flight Manual must include an operating limitation to prohibit flight into weather conditions with potential lightning.

Comment Summary: An individual requested the FAA revise the criteria to include a similar design mitigation or operating limitation for High Intensity Radiated Fields (HIRF). The commenter noted that HIRF is included in proposed UAS.300(e) as part of the expected environmental conditions that must be replicated in testing.

FAA Response: The airworthiness criteria, which are adopted as proposed, address the issue raised by the commenter. The applicant must identify tested HIRF exposure capabilities, if any, in the Flight Manual to comply with the criteria in D&R.200(a)(5). Information regarding HIRF capabilities is necessary for safe operation because proper communication and software execution may be impeded by HIRF-generated interference, which could result in loss of control of the UA. It is not feasible to measure HIRF at every potential location where the UA will operate; thus, requiring operating limitations for HIRF as requested by the commenter would be impractical.

The FAA proposed criteria either requiring that design characteristics protect the UAS from adverse weather conditions or prohibiting flight into known adverse weather conditions. The criteria proposed to define adverse weather conditions as rain, snow, and icing.

Comment Summary: ALPA and two individual commenters requested the FAA expand the proposed definition of adverse weather conditions. These commenters noted that because of the size and physical limitations of the Model Flirtey F4.5, adverse weather should also include wind, downdraft, low-level wind shear (LLWS), microburst, and extreme mechanical turbulence.

FAA Response: No additional language needs to be added to the airworthiness criteria to address wind effects. The wind conditions specified by the commenters are part of normal UA flight operations. The applicant must demonstrate by flight test that the UA can withstand wind without failure to meet the requirements of D&R.300(b)(9). The FAA developed the criteria in D&R.130 to address adverse weather conditions (rain, snow, and icing) that would require additional design characteristics for safe operation. Any operating limitations necessary for operation in adverse weather or wind conditions will be included in the Flight Manual as required by D&R.200.

Comment Summary: One commenter questioned whether the criteria proposed in UAS.130(c)(2), requiring a means to detect adverse weather conditions for which the UAS is not certificated to operate, is a prescriptive requirement to install an onboard detection system. The commenter requested, if that was the case, that the FAA allow alternative procedures to avoid flying in adverse weather conditions.

FAA Response: The language referred to by the commenter is not a prescriptive design requirement for an onboard detection system. The applicant may use any acceptable source to monitor weather in the area, whether onboard the UA or from an external source.

The FAA proposed criteria for critical parts that were substantively the same as those in the existing standards for normal category rotorcraft under § 27.602, with changes to reflect UAS terminology and failure conditions. The criteria proposed to define a critical part as a part, the failure of which could result in a loss of flight or unrecoverable loss of control of the aircraft.

Comment Summary: EASA requested the FAA avoid using the term “critical part,” as it is a well-established term for complex manned aircraft categories and may create incorrect expectations on the oversight process for parts.

FAA Response: For purposes of the airworthiness criteria established for the Flirtey Model F4.5 UA, the FAA has changed the term “critical part” to “flight essential part.”

Comment Summary: An individual commenter requested the FAA revise the proposed criteria such that a failure of a flight essential part would only occur if there is risk to third parties.

FAA Response: The definition of “flight essential” does not change regardless of whether on-board systems are capable of safely landing the UA when it is unable to continue its flight plan. Tying the definition of a flight essential part to the risk to third parties would result in different definitions for the part depending on where and how the UA is operated. These criteria for the Model Flirtey F4.5 UA apply the same approach as for manned aircraft.

The FAA proposed criteria for the Flight Manual that were substantively the same as the existing standards for normal category airplanes, with minor changes to reflect UAS terminology.

Comment Summary: ALPA requested the FAA revise the criteria to include normal, abnormal, and emergency operating procedures along with their respective checklist. ALPA further requested the checklist be contained in a quick reference handbook (QRH).

FAA Response: The FAA did not intend for the airworthiness criteria to exclude abnormal procedures from the flight manual. In these final airworthiness criteria, the FAA has changed “normal and emergency operating procedures” to “operating procedures” to encompass all operating conditions and align with 14 CFR 23.2620, which includes the airplane flight manual requirements for normal category airplanes. The FAA has not made any changes to add language that would require the checklists to be included in a QRH. FAA regulations do not require manned aircraft to have a QRH for type certification. Therefore, it would be inconsistent for the FAA to require a QRH for the Flirtey Model Flirtey F4.5 UA.

Comment Summary: ALPA requested the FAA revise the airworthiness criteria to require that the Flight Manual and QRH be readily available to the pilot at the control station.

FAA Response: ALPA's request regarding the Flight manual addresses an operational requirement, similar to 14 CFR 91.9 and is therefore not appropriate for type certification airworthiness criteria. Also, as previously discussed, FAA regulations do not require a QRH. Therefore, it would be inappropriate to require it to be readily available to the pilot at the control station.

Comment Summary: Droneport Texas LLC requested the FAA revise the airworthiness criteria to add required Flight Manual sections for routine maintenance and mission-specific equipment and procedures. The commenter stated that the remote pilot or personnel on the remote pilot-in-command's flight team accomplish most routine maintenance, and that the flight team usually does UA rigging with mission equipment.

FAA Response: The requested change is appropriate for a maintenance document rather than a flight manual because it addresses maintenance procedures rather than the piloting functions. The FAA also notes that, similar to the criteria for certain manned aircraft, the airworthiness criteria require that the applicant prepare instructions for continued airworthiness (ICA) in accordance with appendix A to part 23. As the applicant must provide any maintenance instructions and mission-specific information necessary for safe operation and continued operational safety of the UA, in accordance with D&R.205, no changes to the airworthiness criteria are necessary.

Comment Summary: An individual commenter requested the FAA revise the criteria in proposed UAS.200(b) to require that “other information” referred to in proposed UAS.200(a)(5) be approved by the FAA. The commenter noted that, as proposed, only the information listed in UAS.200(a)(1) through (4) must be FAA approved.

FAA Response: The change requested by the commenter would be inconsistent with the FAA's airworthiness standards for flight manuals for manned aircraft. Sections 23.2620(b), 25.1581(b), 27.1581(b), and 29.1581(b) include requirements for flight manuals to include operating limitations, operating procedures, performance information, loading information, and other information that is necessary safe operation because of design, operating, or handling characteristics, but limit FAA approval to operating limitations, operating procedures, performance information, and loading information.

Under § 23.2620(b)(1), for low-speed level 1 and level 2 airplanes, the FAA only approves the operating limitations. In applying a risk-based approach, the FAA has determined it would not be appropriate to hold the lowest risk UA to a higher standard than what is required for low speed level 1 and level 2 manned aircraft. Accordingly, the FAA has revised the airworthiness criteria to only require FAA approval of the operating limitations.

Comment Summary: NUAIR requested the FAA recognize that § 23.2620 is only applicable to the aircraft and does not address off-aircraft components such as the control station, control and non-payload communications (CNPC) data link, and launch and recovery equipment. The commenter noted that this is also true of industry consensus-based standards designed to comply with § 23.2620.

FAA Response: As explained in more detail in the Control Station section of this document, the FAA has revised the airworthiness criteria for the AE. The FAA will approve AE or minimum specifications for the AE that could affect airworthiness as an operating limitation in the UA flight manual. The FAA will establish the approved AE or minimum specifications as operating limitations and include them in the UA type certificate data sheet and Flight Manual in accordance with D&R.105(c). The establishment of requirements for, and the approval of AE will be in accordance with FAA Memorandum AIR600-21-AIR-600-PM01, dated July 13, 2021.

The FAA proposed durability and reliability testing that would require the applicant to demonstrate safe flight of the UAS across the entire operational envelope and up to all operational limitations, for all phases of flight and all aircraft configurations described in the applicant's CONOPS, with no failures that result in a loss of flight, loss of control, loss of containment, or emergency landing outside the operator's recovery area. The FAA further proposed that the unmanned aircraft would only be certificated for operations within the limitations, and for flight over areas no greater than the maximum population density, as described in the applicant's CONOPS and demonstrated by test.

Comment Summary: ALPA requested that the proposed certification criteria require all flights during testing be completed in both normal and non-normal or off-nominal scenarios with no failures that result in a loss of flight, loss of control, loss of containment, or emergency landing outside of the operator's recovery zone. Specifically, ALPA stated that testing must not require exceptional piloting skill or alertness and include, at a minimum: All phases of the flight envelope, including the highest UA to pilot ratios; the most adverse combinations of the conditions and configuration; the environmental conditions identified in the CONOPS; the different flight profiles and routes identified in the CONOPS; and exposure to EMI and HIRF.

FAA Response: No change is necessary because the introductory text and paragraphs (b)(7), (b)(9), (b)(10), (b)(13), (c), (d), (e), and (f) of D&R.300, which are adopted as proposed, contain the specific testing requirements requested by ALPA.

Comment Summary: Droneport Texas LLC requested the FAA revise the testing criteria to include, for operation at night, testing both with and without night vision aids. The commenter stated that because small UAS operation at night is waivable under 14 CFR part 107, manufacturers will likely make assumptions concerning a pilot's familiarity with night vision device-aided and unaided operations.

FAA Response: Under D&R.300(b)(11), the applicant must demonstrate by flight test that the UA can operate at night without failure using whatever equipment is onboard the UA itself. The pilot's familiarity, or lack thereof, with night vision equipment does not impact whether the UA is reliable and durable to complete testing without any failures.

Comment Summary: EASA requested the FAA clarify how testing durability and reliability commensurate to the maximum population density, as proposed, aligns with the Specific Operations Risk Assessment (SORA) approach that is open to operational mitigation, reducing the initial ground risk. An individual commenter requested the FAA provide more details about the correlation between the number of flight hours tested and the CONOPS environment ( e.g., population density). The commenter stated that this is one of the most fundamental requirements, and the FAA should ensure equal treatment to all current and future applicants.

FAA Response: In developing these testing criteria, the FAA sought to align the risk of UAS operations with the appropriate level of protection for human beings on the ground. The FAA proposed establishing the maximum population density demonstrated by durability and reliability testing as an operating limitation on the type certificate. However, the FAA has re-evaluated its approach and determined it to be more appropriate to connect the durability and reliability demonstrated during certification testing with the operating environment defined in the CONOPS.

Basing testing on maximum population density may result in limitations not commensurate with many actual operations. As population density broadly refers to the number of people living in a given area per square mile, it does not allow for evaluating variation in a local operating environment. For example, an operator may have a route in an urban environment with the actual flight path along a greenway; the number of human beings exposed to risk from the UA operating overhead would be significantly lower than the population density for the area. Conversely, an operator may have a route over an industrial area where few people live, but where, during business hours, there may be highly dense groups of people. Specific performance characteristics such as altitude and airspeed also factor into defining the boundaries for safe operation of the UA.

Accordingly, the FAA has revised D&R.300 to require the UA design to be durable and reliable when operated under the limitations prescribed for its operating environment. The information in the applicant's CONOPS will determine the operating environment for testing. For example, the minimum hours of reliability testing will be less for a UA conducting agricultural operations in a rural environment than if the same aircraft will be conducting package deliveries in an urban environment. The FAA will include the limitations that result from testing as operating limitations on the type certificate data sheet and in the UA Flight Manual. The FAA intends for this process to be similar to the process for establishing limitations prescribed for special purpose operations for restricted category aircraft. This allows for added flexibility in determining appropriate operating limitations, which will more closely reflect the operating environment.

Finally, a comparison of these criteria with EASA's SORA approach is beyond the scope of this document because the SORA is intended to result in an operational approval rather than a type certificate.

Comment Summary: EASA requested the FAA clarify how reliability at the aircraft level to ensure high-level safety objectives would enable validation of products under applicable bilateral agreements.

FAA Response: As the FAA and international aviation authorities are still developing general airworthiness standards for UA, it would be speculative for the FAA to comment on the validation process for any specific UA.

Comment Summary: EASA requested the FAA revise the testing criteria to include a compliance demonstration related to adverse combinations of the conditions and configurations and with respect to weather conditions and average pilot qualification.

FAA Response: No change is necessary because D&R.300(b)(7), (b)(9), (b)(10), (c), and (f), which are adopted as proposed, contain the specific testing requirements requested by EASA.

Comment Summary: EASA noted that, under the proposed criteria, testing involving a large number of flight hours will limit changes to the configuration.

FAA Response: Like manned aircraft, the requirements of 14 CFR part 21, subpart D, apply to UA for changes to type certificates. The FAA is developing procedures for processing type design changes for UA type certificated using durability and reliability testing.

Comment Summary: EASA requested the FAA clarify whether the proposed testing criteria would require the applicant to demonstrate aspects that do not occur during a successful flight, such as the deployment of emergency recovery systems and fire protection/post-crash fire. EASA asked if these aspects are addressed by other means and what would be the applicable airworthiness criteria.

FAA Response: Equipment not required for normal operation of the UA do not require an evaluation for their specific functionality. D&R testing will show that the inclusion of any such equipment does not prevent normal operation. Therefore, the airworthiness criteria would not require functional testing of the systems described by EASA.

Comment Summary: An individual commenter requested the FAA specify the acceptable percentage of failures in the testing that would result in a “loss of flight.” The Small UAV Coalition requested the FAA clarify what constitutes an emergency landing outside an operator's landing area, as some UAS designs could include an onboard health system that initiates a landing to lessen the potential of a loss of control event. The commenter suggested that, in those cases, a landing in a safe location should not invalidate the test.

FAA Response: The airworthiness criteria require that all test points and flight hours occur with no failures result in a loss of flight, control, containment, or emergency landing outside the operator's recovery zone. The FAA has determined that there is no acceptable percentage of failures in testing. In addition, while the recovery zone may differ for each UAS design, an emergency or unplanned landing outside of a designated landing area would result in a test failure.

Comment Summary: The Small UAV Coalition requested that a single failure during testing not automatically restart counting the number of flight test operations set for a particular population density; rather, the applicant should have the option to identify the failure through root-cause and fault-tree analysis and provide a validated mitigation to ensure it will not recur. An individual commenter requested the FAA to clarify whether the purpose of the tests is to show compliance with a quantitative safety objective. The commenter further requested the FAA allow the applicant to reduce the number of flight testing hours if the applicant can present a predicted safety and reliability analysis.

FAA Response: The intent of the testing criteria is for the applicant to demonstrate the aircraft's durability and reliability through a successful accumulation of flight testing hours. The FAA does not intend to require analytical evaluation to be part of this process. However, the applicant will comply with these testing criteria using a means of compliance, accepted by the FAA, through the issue paper process. The means of compliance will be dependent on the CONOPS the applicant has proposed to meet.

The FAA proposed criteria to evaluate how the UAS functions after probable failures, including failures related to propulsion systems, C2 link, GPS, critical flight control components with a single point of failure, control station, and any other equipment identified by the applicant.

Comment Summary: Droneport Texas LLC requested the FAA add a bird strike to the list of probable failures. The commenter stated that despite sense and avoid technologies, flocks of birds can overcome the maneuver capabilities of a UA and result in multiple, unintended failures.

FAA Response: Unlike manned aircraft, where aircraft size, design, and construct are critical to safe control of the aircraft after encountering a bird strike, the FAA determined testing for bird strike capabilities is not necessary for the Model Flirtey F4.5 UA. The FAA has determined that a bird strike requirement is not necessary because the smaller size and lower operational speed of the Flirtey F4.5 reduce the likelihood of a bird strike, combined with the reduced consequences of failure due to no persons onboard. Instead, the FAA is using a risk-based approach to tailor airworthiness requirements commensurate to the low-risk nature of the Model Flirtey F4.5 UA.

Comment Summary: ALPA requested the FAA require that all probable failure tests occur at the critical phase and mode of flight and at the highest aircraft-to-pilot ratio. ALPA stated the proposed criteria are critically important for systems that rely on a single source to perform multi-label functions, such as GNSS, because failure or interruption of GNSS will lead to loss of positioning, navigation, and timing (PNT) and functions solely dependent on PNT, such as geo-fencing and contingency planning.

FAA Response: No change is necessary because D&R.300(c) requires that the testing occur at the critical phase and mode of flight and at the highest UA-to-pilot ratio.

Comment Summary: Droneport Texas LLC requested the FAA add recovery from vortex ring state (VRS) to the list of probable failures. The commenter stated the UA uses multiple rotors for lift and is therefore susceptible to VRS. The commenter further stated that because recovery from settling with power is beyond a pilot's average skill for purposes of airworthiness testing, the aircraft must be able to sense and recover from this condition without pilot assistance.

FAA Response: D&R.305 addresses probable failures related to specific components of the UAS. VRS is an aerodynamic condition a UA may encounter during flight testing; it is not a component subject to failure.

Comment Summary: Droneport Texas LLC also requested the FAA add a response to the Air Traffic Control-Zero (ATC-Zero) command to the list of probable failures. The commenter stated, based on lessons learned after the attacks on September 11, 2001, aircraft that can fly BVLOS should be able to respond to an ATC-Zero condition.

FAA Response: The commenter's request is more appropriate for the capabilities and functions testing criteria in D&R.310 than probable failures testing in D&R.305. D&R.310(a)(3) requires the applicant to demonstrate by test that the pilot has the ability to safely discontinue a flight. A pilot may discontinue a flight for a wide variety of reasons, including responding to an ATC-zero command.

Comment Summary: EASA stated the proposed language seems to require an additional analysis and safety assessment, which would be appropriate for the objective requirement of ensuring a probable failure does not result in a loss of containment or control. EASA further stated that an applicant's basic understanding of the systems architecture and effects of failures is essential.

FAA Response: The FAA agrees with the expectation that applicants understand the system architecture and effects of failures of a proposed design, which is why the criteria include a requirement for the applicant to test the specific equipment identified in D&R.305 and identify any other equipment that is not specifically identified in D&R.305 for testing. As the intent of the criteria is for the applicant to demonstrate compliance through testing, some analysis may be necessary to properly identify the appropriate equipment to be evaluated for probable failures.

Comment Summary: An individual requested that probable failure testing apply not only to critical flight control components with a single point of failure, but also to any critical part with a single point of failure.

FAA Response: The purpose of probable failure testing in D&R.305 is to demonstrate that if certain equipment fails, it will fail safely. Adding probable failure testing for critical (now flight essential) parts would not add value to testing. If a part is essential for flight, its failure by definition in D&R.135(a) could result in a loss of flight or unrecoverable loss of control. For example, on a traditional airplane design, failure of a wing spar in flight would lead to loss of the aircraft. Because there is no way to show that a wing spar can fail safely, the applicant must provide its mandatory replacement time if applicable, structural inspection interval, and related structural inspection procedure in the Airworthiness Limitations section of the ICA. Similarly, under these airworthiness criteria, parts whose failure would inherently result in loss of flight or unrecoverable loss of control are not subjected to probable failure testing. Instead, they must be identified as flight essential components and included in the ICA.

To avoid confusion pertaining to probable failure testing, the FAA has removed the word “critical” from D&R.305(a)(5). In the final airworthiness criteria, probable failure testing required by D&R.305(a)(5) applies to “Flight control components with a single point of failure.”

The FAA proposed criteria to require the applicant to demonstrate by test the minimum capabilities and functions necessary for the design. UAS.310(a) proposed to require the applicant to demonstrate, by test, the capability of the UAS to regain command and control of the UA after a C2 link loss, the sufficiency of the electrical system to carry all anticipated loads, and the ability of the pilot to override any pre-programming in order to resolve a potential unsafe operating condition in any phase of flight. UAS.310(b) proposed to require the applicant to demonstrate by test certain features if the applicant requests approval of those features (geo-fencing, external cargo, etc.). UAS.310(c) proposed to require the design of the UAS to safeguard against an unintended discontinuation of flight or release of cargo, whether by human action or malfunction.

Comment Summary: ALPA stated the pilot-in-command must always have the capability to input control changes to the UA and override any pre-programming without delay as needed for the safe management of the flight. The commenter requested that the FAA retain the proposed criteria that would allow the pilot to command to: Regain command and control of the UA after loss of the C2 link; safely discontinue the flight; and dynamically re-route the UA. In support, ALPA stated the ability of the pilot to continually command (re-route) the UA, including termination of the flight if necessary, is critical for safe operations and should always be available to the pilot.

Honeywell requested the FAA revise paragraphs (a)(3) and (a)(4) of the criteria (UAS.310) to allow for either the pilot or an augmenting system to safely discontinue the flight and re-route the UA. The commenter stated that a system comprised of detect and avoid, onboard autonomy, and ground system can be used for these functions. Therefore, the criteria should not require that only the pilot can do them.

An individual commenter requested the FAA remove UAS.310(a)(4) of the proposed criteria because requiring the ability for the pilot to dynamically re-route the UA is too prescriptive and redundant with the proposed requirement in UAS.310(a)(3), the ability of the pilot to discontinue the flight safely.

FAA Response: Because the pilot in command is directly responsible for the operation of the UA, the pilot must have the capability to command actions necessary for continued safety. This includes commanding a change to the flight path or, when appropriate, safely terminating a flight. The FAA notes that the ability for the pilot to safely discontinue a flight means the pilot has the means to terminate the flight and immediately and safely return the UA to the ground. This is different from the pilot having the means to dynamically re-route the UA, without terminating the flight, to avoid a conflict.

Therefore, the final airworthiness criteria include D&R.310(a) as proposed (UAS.310(a)).

Comment Summary: ALPA requested the FAA revise the criteria to require that all equipment, systems, and installations conform, at a minimum, to the standards of § 25.1309.

FAA Response: The FAA determined that traditional methodologies for manned aircraft, including the system safety analysis required by § 23.2510, § 25.1309, § 27.1309, or § 29.1309, would be inappropriate to require for the Flirtey Model Flirtey F4.5 due to its smaller size and reduced level of complexity. Instead, the FAA finds that system reliability through testing will ensure the safety of this design.

Comment Summary: ALPA requested the FAA revise the criteria to add a requirement to demonstrate the ability of the UA and pilot to perform all of the contingency plans identified in proposed UAS.120.

FAA Response: No change is necessary because D&R.120 and D&R.305(a)(2), together, require what ALPA requests in its comment. Under D&R.120, the applicant must design the UA to execute a predetermined action in the event of a loss of the C2 link. D&R.305(a)(2) requires the applicant to demonstrate by test that a lost C2 link will not result in a loss of containment or control of the UA. Thus, if the applicant does not demonstrate the predetermined contingency plan resulting from a loss of the C2 link when conducting D&R.305 testing, the test would be a failure due to loss of containment.

Comment Summary: ALPA and an individual commenter requested the FAA revise the criteria so that geo-fencing is a required feature and not optional due to the safety concerns that could result from a UA exiting its operating area.

FAA Response: To ensure safe flight, the applicant must test the proposed safety functions, such as geo-fencing, that are part of the type design of the Model Flirtey F4.5 UA. The FAA determined that geo-fencing is an optional feature because it is one way, but not the only way, to ensure a safely contained operation.

Comment Summary: ALPA requested the FAA revise the criteria so that capability to detect and avoid other aircraft and obstacles is a required feature and not optional.

FAA Response: D&R.310(a)(4) requires the applicant demonstrate the ability for the pilot to safely re-route the UA in flight to avoid a dynamic hazard. The FAA did not prescribe specific design features such as a collision avoidance system to meet D&R.310(a)(4) because there are multiple means to minimize the risk of collision.

Comment Summary: McMahon Helicopter Services requested that the airworthiness criteria require a demonstration of sense-and-avoid technology that will automatically steer the UA away from manned aircraft, regardless of whether the manned aircraft has a transponder. NAAA and an individual commenter requested that the FAA require ADS-B in/out and traffic avoidance software on all UAS. The Small UAV Coalition requested the FAA establish standards for collision avoidance technology, as the proposed criteria are not sufficient for compliance with the operational requirement to see and avoid other aircraft (§ 91.113). The commenters stated that these technologies are necessary to avoid a mid-air collision between UA and manned aircraft.

FAA Response: D&R.310(a)(4) requires the applicant demonstrate the ability for the UA to be safely re-routed in flight to avoid a dynamic hazard. The FAA did not prescribe specific design features, such as the technologies suggested by the commenters, to meet D&R.310(a)(4) because they are not the only means for complying with the operational requirement to see and avoid other aircraft. If an applicant chooses to equip their UA with onboard collision avoidance technology, those capabilities and functions must be demonstrated by test per D&R.310(b)(5).

The FAA proposed to require an evaluation of the UA's performance, maneuverability, stability, and control with a factor of safety.

Comment Summary: EASA requested that the FAA revise its approach to require a similar compliance demonstration as EASA's for “light UAS.” EASA stated the FAA's proposed criteria for verification of limits, combined with the proposed Flight Manual requirements, seem to replace a traditional Subpart Flight. 3 EASA further stated the FAA's approach in the proposed airworthiness criteria might necessitate more guidance and means of compliance than the traditional structure.

FAA Response: The FAA's airworthiness criteria will vary from EASA's light UAS certification requirements, resulting in associated differences in compliance demonstrations. At this time, comment on means of compliance and related guidance material, which are still under development with the FAA and with EASA, would be speculative.

Comment Summary: ALPA requested the FAA conduct an analysis to determine battery reliability and safety, taking into account wind and weather conditions and their effect on battery life. ALPA expressed concern with batteries as the only source of power for an aircraft in the NAS. ALPA further requested the FAA not grant exemptions for battery reserve requirements.

FAA Response: Because batteries are a flight essential part, the applicant must establish mandatory instructions or life limits for batteries under the requirements of D&R.135. In addition, when the applicant conducts its D&R testing, D&R.300(i) prevents the applicant from exceeding the maintenance intervals or life limits for those batteries. To the extent the commenter's request addresses fuel reserves, that is an operational requirement, not a certification requirement, and therefore beyond the scope of this document.

Comment Summary: McMahon Helicopter Services requested that the criteria require anti-collision and navigation lighting certified to existing FAA standards for brightness and size. The commenter stated that these standards were based on human factors for nighttime and daytime recognition and are not simply a lighting requirement. An individual commenter requested that the criteria include a requirement for position lighting and anti-collision beacons meeting TSO-30c Level III. NAAA requested the criteria require a strobe light and high visibility paint scheme to aid in visual detection of the UA by other aircraft.

FAA Response: The FAA determined it is unnecessary for these airworthiness criteria to prescribe specific design features for anti-collision or navigation lighting. The FAA will address anti-collision lighting as part of any operational approval, similar to the rules in 14 CFR 107.29(a)(2) and (b) for small UAS.

Comment Summary: ALPA requested the FAA add a new section with minimum standards for Global Navigation Satellite System (GNSS), as the UAS will likely rely heavily upon GNSS for navigation and to ensure that the UA does not stray outside of its approved airspace. ALPA stated that technological advances have made such devices available at an appropriate size, weight, and power for UAs.

FAA Response: The airworthiness criteria in D&R.100 (UA Signal Monitoring and Transmission), D&R.110 (Software), D&R.115 (Cybersecurity), and D&R.305(a)(3) (probable failures related to GPS) sufficiently address design requirements and testing of navigation systems. Even if the applicant uses a TSO-approved GNSS, these airworthiness criteria require a demonstration that the UA operates successfully without loss of containment. Successful completion of these tests demonstrates that the navigation subsystems are acceptable.

Comment Summary: ALPA requested the FAA revise the criteria to add a new section requiring equipage to comply with the FAA's new rules on Remote Identification of Unmanned Aircraft (86 FR 4390, Jan. 15, 2021). An individual commenter questioned the need for public tracking and identification of drones in the event of a crash or violation of FAA flight rules.

FAA Response: The FAA issued the final rule, Remote Identification of Unmanned Aircraft, after providing an opportunity for public notice and comment. The final rule is codified at 14 CFR part 89. Part 89 contains the remote identification requirements for unmanned aircraft certificated and produced under part 21 after September 16, 2022.

Comment Summary: ALPA and an individual questioned the safety of multiple Model Flirtey F4.5 UA operated by a single pilot, up to a ratio of 20 UA to 1 pilot. ALPA stated that even with high levels of automation, the pilot must still manage the safe operation and maintain situational awareness of multiple aircraft in their flight path, aircraft systems, integration with traffic, obstacles, and other hazards during normal, abnormal, and emergency conditions. As a result, ALPA recommended the FAA conduct additional studies to better understand the feasibility of a single pilot operating multiple UA before developing airworthiness criteria. The Small UAV Coalition requested the FAA provide criteria for an aircraft-to-pilot ratio higher than 20:1.

FAA Response: These airworthiness criteria are specific to the Model Flirtey F4.5 UA and, as discussed previously in this preamble, operations of the Model Flirtey F4.5 UA may include multiple UA operated by a single pilot, up to a ratio of 20 UA to 1 pilot. Additionally, these airworthiness criteria require the applicant to demonstrate the durability and reliability of the UA design by flight test, at the highest aircraft-to-pilot ratio, without exceptional piloting skill or alertness. In addition, D&R.305(c) requires the applicant to demonstrate probable failures by test at the highest aircraft-to-pilot ratio. Should the pilot ratio cause a loss of containment or control of the UA, then the applicant will fail this testing.

Comment Summary: ALPA stated that to allow a UAS-pilot ratio of up to 20:1 safely, the possibility that the pilot will need to intervene with multiple UA simultaneously must be “extremely remote.” ALPA questioned whether this is feasible given the threat of GNSS interference or unanticipated wind gusts exceeding operational limits.

FAA Response: The FAA's guidance in AC 23.1309-1E, System Safety Analysis and Assessment for Part 23 Airplanes defines “extremely remote failure conditions” as failure conditions not anticipated to occur during the total life of an airplane, but which may occur a few times when considering the total operational life of all airplanes of the same type. When assessing the likelihood of a pilot needing to intervene with multiple UA simultaneously, the minimum reliability requirements will be determined based on the applicant's proposed CONOPS.

Comment Summary: An individual commenter expressed concern about noise pollution.

FAA Response: The Model Flirtey F4.5 will need to comply with FAA noise certification standards. If the FAA determines that 14 CFR part 36 does not contain adequate standards for this design, the agency will propose and seek public comment on a rule of particular applicability for noise requirements under a separate rulemaking docket.

Comment Summary: ALPA, McMahon Helicopter Services, and NAAA commented on the operation of UAS at or below 400 feet AGL. ALPA, McMahon Helicopter Services, and NAAA requested the airworthiness criteria contain measures for safe operation at low altitudes so that UAS are not a hazard to manned aircraft, especially operations involving helicopters; air tours; agricultural applications; emergency medical services; air tanker firefighting; power line and pipeline patrol and maintenance; fish and wildlife service; animal control; military and law enforcement; seismic operations; ranching and livestock relocation; and mapping.

FAA Response: The type certificate only establishes the approved design of the UA. These airworthiness criteria require the applicant show compliance for the UA altitude sought for type certification. While this may result in operating limitations in the flight manual, the type certificate is not an approval for operations. Operations and operational requirements are beyond the scope of this document.

Comment Summary: NUAIR requested the FAA complete and publish its draft AC 21.17-XX, Type Certification Basis for Unmanned Aircraft Systems (UAS), to provide additional guidance, including templates, to those who seek a type design approval for UAS. NUAIR also requested the FAA recognize the industry consensus-based standards applicable to UAS, as Transport Canada has by publishing its AC 922-001, Remotely Piloted Aircraft Systems Safety Assurance.

FAA Response: The FAA will continue to develop policy and guidance for UA type certification and will publish guidance as soon as practicable. The FAA encourages consensus standards bodies to develop means of compliance and submit them to the FAA for acceptance. Regarding Transport Canada AC 922-001, that AC addresses operational approval rather than type certification.

Comment Summary: ALPA requested the FAA ensure that operations, including UA integrity, fall under the safety management system. ALPA further requested the FAA convene a Safety Risk Management Panel before allowing operators to commence operations and that the FAA require operators to have an active safety management system, including a non-punitive safety culture, where incident and continuing airworthiness issues can be reported.

FAA Response: The type certificate only establishes the approved design of the UA, including the Flight Manual and ICA. Operations and operational requirements, including safety management and oversight of operations and maintenance, are beyond the scope of this document.

Comment Summary: ALPA supported the FAA's type certification of UAS as a “special class” of aircraft under § 21.17(b) but requested that it be temporary.

FAA Response: As the FAA stated in its notice of policy issued August 11, 2020 (85 FR 58251, September 18, 2020), the FAA will use the type certification process under § 21.17(b) for some unmanned aircraft with no occupants onboard. The FAA further stated in its policy that it may also issue type certificates under § 21.17(a) for airplane and rotorcraft UAS designs where the airworthiness standards in part 23, 25, 27, or 29, respectively, are appropriate. The FAA, in the future, may consider establishing appropriate generally applicable airworthiness standards for UA that are not certificated under the existing standards in part 23, 25, 27, or 29.

The FAA received and reviewed several comments that were general, stated the commenter's viewpoint or opposition without a suggestion specific to the proposed criteria, or did not make a request the FAA can act on. These comments are beyond the scope of this document.

These airworthiness criteria, established under the provisions of § 21.17(b), are applicable to the Flirtey Model Flirtey F4.5 UA. Should Flirtey wish to apply these airworthiness criteria to other UA models, it must submit a new type certification application.

This action affects only certain airworthiness criteria for the Flirtey Model Flirtey F4.5 UA. It is not a standard of general applicability.

The authority citation for these airworthiness criteria is as follows:

Pursuant to the authority delegated to me by the Administrator, the following airworthiness criteria are issued as part of the type certification basis for the Flirtey Model Flirtey F4.5 unmanned aircraft. The FAA finds that compliance with these criteria appropriately mitigates the risks associated with the design and concept of operations and provides an equivalent level of safety to existing rules.

The applicant must define and submit to the FAA a concept of operations (CONOPS) proposal describing the unmanned aircraft system (UAS) operation in the national airspace system for which unmanned aircraft (UA) type certification is requested. The CONOPS proposal must include, at a minimum, a description of the following information in sufficient detail to determine the parameters and extent of testing and operating limitations:

(a) The intended type of operations;

(b) UA specifications;

(c) Meteorological conditions;

(d) Operators, pilots, and personnel responsibilities;

(e) Control station, support equipment, and other associated elements (AE) necessary to meet the airworthiness criteria;

(f) Command, control, and communication functions;

(g) Operational parameters (such as population density, geographic operating boundaries, airspace classes, launch and recovery area, congestion of proposed operating area, communications with air traffic control, line of sight, and aircraft separation); and

(h) Collision avoidance equipment, whether onboard the UA or part of the AE, if requested.

For purposes of these airworthiness criteria, the following definitions apply.

(a) Loss of Control: Loss of control means an unintended departure of an aircraft from controlled flight. It includes control reversal or an undue loss of longitudinal, lateral, and directional stability and control. It also includes an upset or entry into an unscheduled or uncommanded attitude with high potential for uncontrolled impact with terrain. A loss of control means a spin, loss of control authority, loss of aerodynamic stability, divergent flight characteristics, or similar occurrence, which could generally lead to crash.

(b) Loss of Flight: Loss of flight means a UA's inability to complete its flight as planned, up to and through its originally planned landing. It includes scenarios where the UA experiences controlled flight into terrain, obstacles, or any other collision, or a loss of altitude that is severe or non-reversible. Loss of flight also includes deploying a parachute or ballistic recovery system that leads to an unplanned landing outside the operator's designated recovery zone.

The UA must be designed to monitor and transmit to the AE all information required for continued safe flight and operation. This information includes, at a minimum, the following:

(a) Status of all critical parameters for all energy storage systems;

(b) Status of all critical parameters for all propulsion systems;

(c) Flight and navigation information as appropriate, such as airspeed, heading, altitude, and location; and

(d) Communication and navigation signal strength and quality, including contingency information or status.

(a) The applicant must identify and submit to the FAA all AE and interface conditions of the UAS that affect the airworthiness of the UA or are otherwise necessary for the UA to meet these airworthiness criteria. As part of this requirement—

(1) The applicant may identify either specific AE or minimum specifications for the AE.

(i) If minimum specifications are identified, they must include the critical requirements of the AE, including performance, compatibility, function, reliability, interface, pilot alerting, and environmental requirements.

(ii) Critical requirements are those that if not met would impact the ability to operate the UA safely and efficiently.

(2) The applicant may use an interface control drawing, a requirements document, or other reference, titled so that it is clearly designated as AE interfaces to the UA.

(b) The applicant must show the FAA the AE or minimum specifications identified in paragraph (a) of this section meet the following:

(1) The AE provide the functionality, performance, reliability, and information to assure UA airworthiness in conjunction with the rest of the design;

(2) The AE are compatible with the UA capabilities and interfaces;

(3) The AE must monitor and transmit to the pilot all information required for safe flight and operation, including but not limited to those identified in D&R.100; and

(4) The minimum specifications, if identified, are correct, complete, consistent, and verifiable to assure UA airworthiness.

(c) The FAA will establish the approved AE or minimum specifications as operating limitations and include them in the UA type certificate data sheet and Flight Manual.

(d) The applicant must develop any maintenance instructions necessary to address implications from the AE on the airworthiness of the UA. Those instructions will be included in the instructions for continued airworthiness (ICA) required by D&R.205.

To minimize the existence of software errors, the applicant must:

(a) Verify by test all software that may impact the safe operation of the UA;

(b) Utilize a configuration management system that tracks, controls, and preserves changes made to software throughout the entire life cycle; and

(c) Implement a problem reporting system that captures and records defects and modifications to the software.

(a) UA equipment, systems, and networks, addressed separately and in relation to other systems, must be protected from intentional unauthorized electronic interactions that may result in an adverse effect on the security or airworthiness of the UA. Protection must be ensured by showing that the security risks have been identified, assessed, and mitigated as necessary.

(b) When required by paragraph (a) of this section, procedures and instructions to ensure security protections are maintained must be included in the ICA.

(a) The UA must be designed so that, in the event of a loss of the command and control (C2) link, the UA will automatically and immediately execute a safe predetermined flight, loiter, landing, or termination.

(b) The applicant must establish the predetermined action in the event of a loss of the C2 link and include it in the UA Flight Manual.

(c) The UA Flight Manual must include the minimum performance requirements for the C2 data link defining when the C2 link is degraded to a level where remote active control of the UA is no longer ensured. Takeoff when the C2 link is degraded below the minimum link performance requirements must be prevented by design or prohibited by an operating limitation in the UA Flight Manual.

(a) Except as provided in paragraph (b) of this section, the UA must have design characteristics that will protect the UA from loss of flight or loss of control due to lightning.

(b) If the UA has not been shown to protect against lightning, the UA Flight Manual must include an operating limitation to prohibit flight into weather conditions conducive to lightning activity.

(a) For purposes of this section, “adverse weather conditions” means rain, snow, and icing.

(b) Except as provided in paragraph (c) of this section, the UA must have design characteristics that will allow the UA to operate within the adverse weather conditions specified in the CONOPS without loss of flight or loss of control.

(c) For adverse weather conditions for which the UA is not approved to operate, the applicant must develop operating limitations to prohibit flight into known adverse weather conditions and either:

(1) Develop operating limitations to prevent inadvertent flight into adverse weather conditions; or

(2) Provide a means to detect any adverse weather conditions for which the UA is not certificated to operate and show the UA's ability to avoid or exit those conditions.

(a) A flight essential part is a part, the failure of which could result in a loss of flight or unrecoverable loss of UA control.

(b) If the type design includes flight essential parts, the applicant must establish a flight essential parts list. The applicant must develop and define mandatory maintenance instructions or life limits, or a combination of both, to prevent failures of flight essential parts. Each of these mandatory actions must be included in the Airworthiness Limitations Section of the ICA.

The applicant must provide a Flight Manual with each UA.

(a) The UA Flight Manual must contain the following information:

(1) UA operating limitations;

(2) UA operating procedures;

(3) Performance information;

(4) Loading information; and

(5) Other information that is necessary for safe operation because of design, operating, or handling characteristics.

(b) Those portions of the UA Flight Manual containing the information specified in paragraph (a)(1) of this section must be approved by the FAA.

The applicant must prepare ICA for the UA in accordance with Appendix A to Part 23, as appropriate, that are acceptable to the FAA. The ICA may be incomplete at type certification if a program exists to ensure their completion prior to delivery of the first UA or issuance of a standard airworthiness certificate, whichever occurs later.

The UA must be designed to be durable and reliable when operated under the limitations prescribed for its operating environment, as documented in its CONOPS and included as operating limitations on the type certificate data sheet and in the UA Flight Manual. The durability and reliability must be demonstrated by flight test in accordance with the requirements of this section and completed with no failures that result in a loss of flight, loss of control, loss of containment, or emergency landing outside the operator's recovery area.

(a) Once a UA has begun testing to show compliance with this section, all flights for that UA must be included in the flight test report.

(b) Tests must include an evaluation of the entire flight envelope across all phases of operation and must address, at a minimum, the following:

(1) Flight distances;

(2) Flight durations;

(3) Route complexity;

(4) Weight;

(5) Center of gravity;

(6) Density altitude;

(7) Outside air temperature;

(8) Airspeed;

(9) Wind;

(10) Weather;

(11) Operation at night, if requested;

(12) Energy storage system capacity; and

(13) Aircraft to pilot ratio.

(c) Tests must include the most adverse combinations of the conditions and configurations in paragraph (b) of this section.

(d) Tests must show a distribution of the different flight profiles and routes representative of the type of operations identified in the CONOPS.

(e) Tests must be conducted in conditions consistent with the expected environmental conditions identified in the CONOPS, including electromagnetic interference (EMI) and high intensity radiated fields (HIRF).

(f) Tests must not require exceptional piloting skill or alertness.

(g) Any UAS used for testing must be subject to the same worst-case ground handling, shipping, and transportation loads as those allowed in service.

(h) Any UA used for testing must use AE that meet, but do not exceed, the minimum specifications identified under D&R.105. If multiple AE are identified, the applicant must demonstrate each configuration.

(i) Any UAS used for testing must be maintained and operated in accordance with the ICA and UA Flight Manual. No maintenance beyond the intervals established in the ICA will be allowed to show compliance with this section.

(j) If cargo operations or external-load operations are requested, tests must show, throughout the flight envelope and with the cargo or external-load at the most critical combinations of weight and center of gravity, that—

(1) The UA is safely controllable and maneuverable; and

(2) The cargo or external-load are retainable and transportable.

The UA must be designed such that a probable failure will not result in a loss of containment or control of the UA. This must be demonstrated by test.

(a) Probable failures related to the following equipment, at a minimum, must be addressed:

(1) Propulsion systems;

(2) C2 link;

(3) Global Positioning System (GPS);

(4) Flight control components with a single point of failure;

(5) Control station; and

(6) Any other AE identified by the applicant.

(b) Any UA used for testing must be operated in accordance with the UA Flight Manual.

(c) Each test must occur at the critical phase and mode of flight, and at the highest aircraft-to-pilot ratio.

(a) All of the following required UAS capabilities and functions must be demonstrated by test:

(1) Capability to regain command and control of the UA after the C2 link has been lost.

(2) Capability of the electrical system to power all UA systems and payloads.

(3) Ability for the pilot to safely discontinue the flight.

(4) Ability for the pilot to dynamically re-route the UA.

(5) Ability to safely abort a takeoff.

(6) Ability to safely abort a landing and initiate a go-around.

(b) The following UAS capabilities and functions, if requested for approval, must be demonstrated by test:

(1) Continued flight after degradation of the propulsion system.

(2) Geo-fencing that contains the UA within a designated area, in all operating conditions.

(3) Positive transfer of the UA between control stations that ensures only one control station can control the UA at a time.

(4) Capability to release an external cargo load to prevent loss of control of the UA.

(5) Capability to detect and avoid other aircraft and obstacles.

(c) The UA must be designed to safeguard against inadvertent discontinuation of the flight and inadvertent release of cargo or external load.

The structure of the UA must be shown to withstand the repeated loads expected during its service life without failure. A life limit for the airframe must be established, demonstrated by test, and included in the ICA.

The performance, maneuverability, stability, and control of the UA within the flight envelope described in the UA Flight Manual must be demonstrated at a minimum of 5% over maximum gross weight with no loss of control or loss of flight.

The Convention on Cultural Property Implementation Act, Public Law 97-446, 19 U.S.C. 2601 et seq. (hereinafter, “the Cultural Property Implementation Act”), implements the 1970 United Nations Educational, Scientific and Cultural Organization (UNESCO) Convention on the Means of Prohibiting and Preventing the Illicit Import, Export and Transfer of Ownership of Cultural Property (hereinafter, “the Convention” (823 U.N.T.S. 231 (1972)). Pursuant to the Cultural Property Implementation Act, the United States entered into a bilateral agreement with the Republic of Albania (Albania) to impose import restrictions on certain archaeological and ethnological material from Albania. This rule announces the imposition of import restrictions on certain archaeological and ethnological material from Albania.

Under 19 U.S.C. 2602(a)(1), the United States must make certain determinations before entering into an agreement to impose import restrictions under 19 U.S.C. 2602(a)(2). On May 26, 2021, the Acting Assistant Secretary for Educational and Cultural Affairs, United States Department of State, after consultation with and recommendation by the Cultural Property Advisory Committee, made the determinations required under the statute with respect to certain archaeological and ethnological material originating in Albania that is described in the Designated List set forth below in this document.

These determinations include the following: (1) That Albania's cultural heritage is in jeopardy from pillage of certain types of archaeological material representing Albania's cultural heritage ranging in date from approximately 300,000 B.C. to A.D. 1750, and certain types of ethnological material representing Albania's cultural heritage ranging in date from approximately A.D. 400 to 1913 (19 U.S.C. 2602(a)(1)(A)); (2) that the Albanian government has taken measures consistent with the Convention to protect its cultural patrimony (19 U.S.C. 2602(a)(1)(B)); (3) that import restrictions imposed by the United States would be of substantial benefit in deterring a serious situation of pillage and remedies less drastic are not available (19 U.S.C. 2602(a)(1)(C)); and (4) that the application of import restrictions as set forth in this final rule is consistent with the general interests of the international community in the interchange of cultural property among nations for scientific, cultural, and educational purposes (19 U.S.C. 2602(a)(1)(D)). The Acting Assistant Secretary also found that the material described in the determinations meets the statutory definition of “archaeological or ethnological material of the State Party” (19 U.S.C. 2601(2)).

On August 23, 2021, the Governments of the United States and Albania signed a bilateral agreement, “Memorandum of Understanding between the United States of America and the Republic of Albania Concerning the Imposition of Import Restrictions on Categories of Archaeological and Ethnological Material of Albania” (hereinafter, “the Agreement”), pursuant to the provisions of 19 U.S.C. 2602(a)(2). The Agreement entered into force on February 28, 2022, following the exchange of diplomatic notes, and enables the promulgation of import restrictions on certain categories of archaeological material ranging in date from approximately 300,000 B.C. to A.D. 1750, and ethnological material ranging in date from approximately A.D. 400 to 1913. A list of the categories of archaeological and ethnological material subject to the import restrictions is set forth later in this document.

In accordance with the Agreement, importation of material designated below is subject to the restrictions of 19 U.S.C. 2606 and § 12.104g(a) of title 19 of the Code of Federal Regulations (19 CFR 12.104g(a)) and will be restricted from entry into the United States unless the conditions set forth in 19 U.S.C. 2606 and § 12.104c of the CBP regulations (19 CFR 12.104c) are met. CBP is amending § 12.104g(a) of the CBP regulations (19 CFR 12.104g(a)) to indicate that these import restrictions have been imposed.

Import restrictions listed at 19 CFR 12.104g(a) are effective for no more than five years beginning on the date on which the Agreement enters into force with respect to the United States. This period may be extended for additional periods of not more than five years if it is determined that the factors which justified the Agreement still pertain and no cause for suspension of the Agreement exists. The import restrictions will expire on February 28, 2027, unless extended.

The Agreement between the United States and Albania includes, but is not limited to, the categories of objects described in the Designated List set forth below. Importation of material on this list is restricted unless the material is accompanied by documentation certifying that the material left Albania legally and not in violation of the export laws of Albania.

The Designated List includes certain archaeological and ethnological material from Albania. The archaeological material in the Designated List includes archaeological material from the Middle Paleolithic to the Ottoman period, ranging in date from approximately 300,000 B.C. to A.D. 1750. The ethnological material in the Designated List includes ethnological material from the Byzantine, Medieval, and Ottoman periods, ranging in date from approximately A.D. 400 to Albanian independence in 1913. The Designated List is representative only. Any dates and dimensions are approximate.

Archaeological material covered by the Agreement represents the following periods, styles, and cultures: Paleolithic, Mesolithic, Neolithic, Chalcolithic, Bronze Age, Iron Age, Urban period, Roman period, Byzantine/Medieval period, and Ottoman period.

a. Architectural Elements—Primarily in marble, limestone, and gypsum; including blocks from walls, floors, and ceilings; acroteria, antefixes, architrave, water spouts, columns, capitals, bases, lintels, jambs, friezes, pediments, tympanum, metopes, and pilasters; doors, door frames, and window fittings; caryatids, altars, prayer niches ( mihrabs ), screens, wellheads, fountains, mosaics, and tiles. This category also includes relief and inlay sculpture that may have been part of a building, such as friezes of sculptured stone figures set into inlaid stone. May be plain, molded, carved, or inscribed. Decorative motifs may be incised or in high relief.

b. Monuments and Stelae—Types include menhir, votive statues, funerary and votive stelae, bases and base revetments, and carved relief vases and slabs, usually in limestone, marble, or basalt. Common subject matter also includes figural, vegetative, floral, or decorative motifs. These may be painted, carved with relief sculpture, and/or carry dedicatory or funerary inscriptions.

c. Sarcophagi and Ossuaries—In marble and limestone. The sides and lids of sarcophagi and ossuaries may have relief sculptures of human and animal figures, inscriptions, monograms, and floral and geometric decoration.

d. Statuary—Both large and small, in marble, limestone, sandstone, and other stone. Subject matter includes human and animal figures and groups of figures in the round, as well as floral, vegetal and abstract elements, including fragments of statues.

2. Vessels and Containers—In marble, steatite, rock crystal, and other stone. Types include conventional shapes, such as bowls, cups, jars, jugs, and lamps, or may be in the shape of a human or animal, or part of a human or animal.

3. Furniture—In marble and other stone. Types include tables, thrones, beds, funerary furniture, and other burial elements.

4. Tools and Weapons—In flint, chert, obsidian, limestone, and other hard stone. Types include small tools, large and small blades, borers, scrapers, sickles, awls, harpoons, cores, loom weights, and arrow heads. Ground stone types include grinders ( e.g., mortars, pestles, millstones, and/or whetstones), choppers, axes, hammers, molds, and mace heads.

5. Seals and Stamps—These are small devices with at least one side engraved with a design for stamping or sealing, often in marble, limestone, and various semiprecious stones, including rock crystal, amethyst, jasper, agate, steatite, and carnelian. Shapes can include cylinders, buttons, and prismatic.

6. Jewelry and Beads—Jewelry made of or decorated with colored and semi-precious stones, including beads, necklaces, pendants, cameos, crowns, earrings, finger rings, bracelets, anklets, belts, girdles, pins, hair ornaments, and arm bands. May be incised or cut as gems or cameos.

a. Statuary—Large and small statuary, primarily in bronze, including fragments of statues. Subject matter includes human and animal figures, masks, plaques, and groups of figures in the round.

b. Reliefs—In gold, bronze, or lead. Types include plaques, burial masks, leaves, and appliqués with images of gods, mythical creatures, or other figures.

c. Inscribed or Decorated Sheets—In bronze and lead. Engraved inscriptions, “military diplomas,” “curse tablets,” and thin metal sheets with engraved or impressed designs often used as attachments to furniture.

2. Vessels and Containers—In copper, bronze, gold, and silver. Bronze may be gilded or silver-plated. Types include conventional shapes, such as bowls, cups, jars, jugs, strainers, cauldrons, candelabras, and lamps, or may be in the shape of a human or animal or part of a human or animal.

3. Jewelry and Personal Adornment—In copper, bronze, silver, and gold. Types include earrings, ear caps, pendants, bracelets, necklaces, spiraliform tubes, brooches, torques, belts, belt buckles, belt ends/appliqués, fibulas with chain pendants, plates, spangles, diadems, pins, dress pins, finger rings, hair rings, chains, spirals, ornaments, beads, mirrors, wreaths, cuffs, and pectoral crosses.

4. Tools—In bronze, iron, lead, and copper. Types include socketed hammers, spearheads, lanceheads, daggers, knives, axes, double axes, hooks, weights, scrapers, trowels, keys, strigils, and other tools of physicians and artisans.

5. Weapons and Armor—In copper, bronze, lead and iron. This category includes common weapon types, such as daggers, arrows, swords, spears, javelins, axes, rapiers, and maces. Body armor is also included, such as helmets, cuirasses, shin guards, shields, horse armor, and chariot decoration. Some may have inscriptions or be otherwise decorated with engraved, embossed, or perforated designs.

6. Seals and Stamps—These are small devices with at least one side engraved with a design for sealing or stamping, often in bronze, copper, gold, silver, tin, or lead. Types include rings, amulets, stamps, and seals with shank.

7. Ship and Boat Material—Parts and fragments from shipwrecks in bronze, lead, and iron, including anchors.

8. Coins—This category includes coins of Illyrian, Greek, Macedonian, Roman provincial, Byzantine, Medieval, and Ottoman types that circulated primarily in Albania, ranging in date from approximately the 6th century B.C. to A.D. 1750. Coins were made in copper, bronze, silver, and gold. Examples are generally round, have writing, and show imagery of animals, buildings, symbols, or royal or imperial figures.

a. Architectural Elements—Baked clay (terracotta) elements used to decorate buildings. Elements include tiles, acroteria, antefixes, painted and relief plaques, metopes, cornices, roof tiles, pipes, and revetments, as well as wall and floor decorations in plaster. May be painted as icons.

b. Statuary—Large and small statuary. Subject matter includes human and animal figures and groups of figures in the round, human body parts, shrines, houses, ovens, rhyta, strainers, and chariots. This includes figurines which may be anthropomorphic, zoomorphic, vegetal, furniture-like, schematic, or flat.

2. Vessels—Ceramic types, forms, and decoration vary among archaeological styles over time. Forms may be handmade or produced with ceramic wheels, plain or decorated, and may be glazed, unglazed, slipped, painted, burnished, engraved, and/or incised. They may be produced in Albania or imported at or near the time of production. Some of the most well-known types are highlighted below:

a. Neolithic Pottery—Early Neolithic types include thick-walled, coarse, fine, fine with sand inclusion, red, brown, and black pottery. Decorations, applications, and paint include sandy slip, barbotine, red monochrome, or dark brown paint on red barbotine ware. Middle Neolithic types include gray or black, lustrous, incised, and beaded pottery. Decorations include incised bands filled with dots or lines, incised spiral motifs, or white paint. Late Neolithic types include light yellow ocherous fabric, red ocherous fabric with painted decoration, black ware with incisions and appliqués, brown on light painted, clay mixed with sand, brown with broad lines and triangles, unpolished, net patterns, zig-zag lines, fine, polished, painted, multi-colored, linear-geometric, and spiral pottery. Shapes include globular, spherical, hemispherical, and biconical vessels.

b. Chalcolithic Pottery—This category includes similar types and decorations as described above for earlier periods, with the addition of thick-walled, thin-walled mixed with sand, gray surface, brown surface, black surface, fine, and gray-black pottery. They may be painted, incised, encrusted, recessed, or in relief, sometimes representing combined techniques. Prominently black monochrome with fluted decoration. Shapes include squat biconical bodies with cylindrical necks and bowls with incurving rims.

c. Bronze Age Pottery—Types include thick-walled and thin-walled vessels, which are black, gray, gray-black, red, light beige, or ocherous yellow, handmade and wheel-made, as well as Mycenaean (Late Helladic) imported wares. Decorations include bands, punctuated plastic bands, incised linear or curvilinear motifs, geometric motifs, horizontal bands with or without holes, finger impressed bands, matte-painted with geometric patterns, applied plastic decoration, monochrome painted motifs, and/or piercing at juncture of rim and handle. Shapes include pots with handles rising above the rim, vessels with wide necks and exaggerated vertical handles, vessels with bulbous bodies, wide necks, and thick lips, cups with handles, piriform cups with handles that rise above the rim, vessels with elbow or axeblade-shaped handles, vessels with wish bone handles, bowls, vessels with wide throats, vessels with horizontal handles, vessels with handle and spout, short open vessels with two handles, and double vessels.

d. Iron Age Pottery—Types include brown, gray, red, black, clean fabric mixed with sand, thin-walled, and smooth surface pottery, both handmade and wheel-made. Decorations include brown matte-painted linear or curvilinear motifs, narrow ribbing, incised geometric patterns, including triangles and concentric bands, and red paint on black glaze. Shapes include vessels with globular bodies and cylindrical or conical necks with vertical handles, jars with globular necks, beaked jugs, spherical vessels, double vessels, vessels with narrow throats, vessels with handles rising above the rim, pots, beaked oinochoe, skyphoi, amphorae, conical bowls with upright or incurving rims, hemispherical bowls, cups with various profiles, chalices, biphora, and vessels with four handles.

e. Illyrian, Greek, and Hellenistic Pottery—Types include thin and thick-walled vessels; proto-Corinthian, Corinthian, Attic, Devollian, black-glazed, and other types. Decorations include thick black gloss, as well as Attic and other imported Black Figure and Red Figure vessels, including local imitations of these types. Shapes include lekythoi (small, thin-walled jars), large storage amphorae, oinochoe, pyxides, unguentaria, skyphoi, and others.

f. Roman Pottery—Types include fineware, coarseware, red gloss, red slip, black slip, lead glaze, and others. Shapes include cooking ware, jars, beakers, bowls, plates, vases, amphorae, and others.

g. Byzantine/Medieval Pottery—Types include thin and thick-walled vessels with fine to coarse fabrics, often deep red to purplish with lime inclusions and sandy texture, or dark orange with many lime inclusions and voids. Decorations include red slips, plain glazes, colored glazes, particularly green and silver, sgraffito incised naturalistic, geometric, and figural decoration, painted geometric motifs, including dots, ridge surface treatment, and proto-Maiolica ware. Shapes include amphorae, open and closed jugs, large storage vessels with small handles, and shallow plate-like vessels.

h. Ottoman Pottery—Types include thin and thick-walled vessels with fine to coarse fabrics, often deep red to purplish with lime inclusions and sandy texture. Decorations include plain glazes, colored glazes, particularly green and brown, painted glaze, sgraffito incised decoration, painted geometric motif, and Maiolica ware.

3. Objects of Daily Use—This type includes objects of daily use including tools, spindle whorls, weights, and lamps.

4. Inscriptions—These are typically unbaked and should be handled with extreme care, even when hard fired through accidental burning. They typically take the form of tablets, which may be shaped like leaves or may be rectangular or square. In various languages and scripts.

1. Small Statuary and Figurines—This category includes human and animal figures and groups of figures in the round.

2. Personal Ornaments and Objects of Daily Use—In bone, ivory, shell, amber, and other organics. Types include tools, ornaments, beads, amulets, combs, pins, spoons, small containers, bracelets, and buckles.

3. Seals and Stamps—These are small objects with at least one side engraved with a design for stamping or sealing. They may be discoid, cuboid, conoid, or in the shape of animals or mythological creatures.

4. Tools and Weapons—Bone, ivory, and horn were used to produce and decorate weapons and tools. Types include needles, awls, chisels, hoes, picks, knives, spearheads, harpoons, and blades.

5. Human and Animal Remains—Skeletal remains from human and animal bodies, found in burials or preserved in other contexts.

6. Musical Instruments—In bone, ivory, and tortoise shell. Types include pipes and flutes.

7. Inscriptions and Writing—On wood, particularly wooden sticks, ivory, and others. In various languages and scripts.

8. Ship and Boat Material—This includes whole or pieces that compose a ship or boat, including logs, planks, and other fittings.

1. Architectural Elements—This includes glass inlay and tesserae pieces from floor and wall mosaics, mirrors, and windows.

2. Vessels—Types include small jars, bowls, animal shaped containers, goblets, spherical containers, candle holders, and perfume jars ( unguentaria ).

3. Beads and Jewelry—Jewelry such as bracelets and rings, pendants, and beads in various shapes ( e.g., circular or globular), may be decorated with symbolic and/or floral reliefs.

This category includes clothing or clothing fragments, carpets, flags or banners, flag bags, wall hangings, blankets, and textiles used during religious practice, and includes objects made from linen, wool, cotton, and silk.

1. Leather—This category includes bags, furniture parts, masks, shields, cases and containers for a variety of uses, sandals, clothing, and manuscript covers. There are examples of religious and/or rare books that were written on leather pages.

2. Papyrus—Documents made from papyrus and written upon. These are often rolled and/or fragmentary.

3. Parchment—Writing material made of animal skin and used to produce manuscripts, including religious, liturgical, and scientific works. These may be single leaves or bound as books or scrolls. These may also have illustrations or illuminated paintings with gold and other colors.

1. Rock Art—Types include human-made markings on stone, cave walls, or rocks in open air, and may be carved or painted. The earliest known examples date from approximately 10,000 B.C.

2. Wall Paintings—This category includes paintings from buildings and tombs. Several methods were used, such as wet-fresco and dry-fresco, and the paintings may be applied to plaster, wood, or stone. Types include simple applied color, bands and borders, landscapes, scenes of people and/or animals in natural or built settings, and religious themes. Tomb paintings may depict gods, goddesses, or funerary scenes, and date primarily from the first millennium BC through the 6th century A.D.

3. Panel Painting (Icons)—An icon is a work of art for religious devotion, normally depicting saints, angels, or other religious figures. These are painted on a wooden panel, often for inclusion in a wooden screen (iconostasis), or else painted onto ceramic panels. May be partially covered with gold or silver, sometimes encrusted with precious or semi-precious stone.

Mosaics are a combination of small three-dimensional pieces of colored stone or glass (tesserae) to create motifs, such as geometric shapes, mythological scenes, floral or animal designs, natural motifs, such as landscapes, and depictions of daily chores. These were generally applied to walls, ceilings, or floors.

Ethnological material covered by the Agreement includes, but is not limited to, architectural elements from historic or religious structures, funerary objects, ritual and ceremonial objects, paintings, written records, textiles, and weapons and armor; all of which contribute to the knowledge of the origins, development, and history of the Albanian people. This includes objects from approximately A.D. 400, starting in the Byzantine period, through the Medieval and Ottoman periods, ending in A.D. 1913, with Albania's independence.

This category includes architectural elements and decoration from religious and historic buildings in all materials. These buildings have distinctive characteristics described below. Examples of architectural elements covered by the Agreement include, but are not limited to, the following objects:

1. Structural and Decorative Architectural Elements—This category includes material from religious or public buildings in stone, ceramic, plaster, wood, and other organic elements, which includes blocks; columns, capitals, bases, lintels, jambs, friezes, and pilasters; beams, panels, doors, door frames, and window fittings; altars and altar partitions, prayer niches ( mihrab ), circular marking slabs ( omphalion ), screens, iconostases, fountains, ceilings, and carved, molded, or painted brick and tile. Metal elements are primarily in copper, brass, lead, and alloys, and may include doors, door fixtures, lathes, finials, chandeliers, screens, and sheets to protect domes. Glass may be incorporated into either structural or decorative elements. This category also includes relief and inlay sculpture, including appliqués and plaques that may have been part of a building. May be plain, molded, carved, or inscribed. Decorative motifs may be incised or in high relief, and may include religious, floral, human, animal, or other motifs.

2. Mosaics—Wall or floor mosaics generally portray religious images and scenes of biblical events. Surrounding panels may contain animal, floral, or geometric designs. They are made from stone and glass cut into small pieces (tesserae) and laid into a plaster matrix.

This category includes objects related to funerary rites and burials in all materials. Examples of funerary objects covered by the Agreement include, but are not limited to, the following objects:

1. Sepulchers—Sepulchers are repositories for human or animal remains, in stone (usually marble or limestone), metal, and wood. Types of burial containers include sarcophagi, caskets, coffins, and chest urns. These may also have associated sculpture in relief or in the round. May be plain or have figural, geometric, or floral motifs, either painted or carved in relief. May also contain human or animal remains.

2. Inscriptions, Memorial Stones, Epitaphs, and Tombstones—This category includes inscribed funerary objects, primarily slabs in marble and ceramic; most frequently engraved with Ottoman Turkish or Greek. These may also have associated sculpture in relief or in the round.

3. Funerary Offerings—This category includes objects in all materials; shrouds and body adornment, such as clothing, jewelry, and accessories; idols, figurines, vessels, beads, weapons, or other ritual or ceremonial offerings; and writing implements, books, and manuscripts.

This category includes objects for use in religious services (Christian, Islamic, or other) or by the state (Byzantine Empire, Medieval period rulers, and Ottoman Empire). Examples of ritual and ceremonial objects covered by the Agreement include, but are not limited to, the following objects:

1. Religious Objects—This category includes objects in all materials, such as lamps, libation vessels, patens, pitchers, chalices, plates, censers, candelabra, crosses and cross pendants, pilgrim flasks, tabernacles, boxes and chests, carved diptychs, triptychs, plaques and appliqués, cast metal icons, liturgical spoons, ecclesiastic crowns, bells, ampoules, prayer beads, icons, amulets, Bektashi surrender stones, and Qu'ran study tablets. This type also includes reliquaries and reliquary containers, which may or may not include human remains. Objects are often engraved, inscribed, inlaid, or otherwise decorated with semi-precious or precious stones.

2. State Ceremonial Objects—This category includes objects in all materials. Examples include ceremonial garments, clothing emblematic of state or imperial position and accessories thereof (such as shoes, headdresses and hats, belts, and jewelry); objects of state office (such as scepters, staffs, insignia, relics, and monumental boxes, trays, and containers); flags, flagstaffs, and alem (finials); stamps, seals, and writing implements for official use by the state; tapestries, or other representations of the court; and musical instruments.

3. Furniture—This category includes objects primarily in stone or wood, including altars, tables, platforms, pulpits, fonts, screens, thrones, minbar, lecterns, desks, and other types of furniture used for religious or official state purpose.

4. Musical Instruments—This category includes instruments important for religious or state ceremonies, such as drums of various sizes in leather ( e.g., bendir drums used in Sufi rituals, wedding processions, and Mal'uf performances), metal instruments, such as cymbals and trumpets, and wooden instruments.

This category includes works of paint on plaster, wood, or ceramic, from religious or historic contexts. Paintings from these periods provide information on the social and religious history of the people of Albania that may be absent from written records. Examples of paintings include, but are not limited to:

1. Wall paintings—This category includes paintings on various types of plaster, which generally portray religious images and/or scenes of biblical events. Types may also include simple applied color, bands and borders, and animal, floral, and geometric motifs.

2. Panel Paintings (Icons)—An icon is a work of art for religious devotion, normally depicting saints, angels, or other religious figures. These are painted on a wooden panel, often for inclusion in a wooden screen (iconostasis), or else painted onto ceramic panels. May be partially covered with gold and/or silver, sometimes encrusted with precious or semi-precious stone.

3. Works on Leather and Paper—Paintings may be on leather, parchment, or paper. Images depicted may include, among other themes, courtly themes ( e.g., rulers, musicians, or riders on horses) and city views.

This category includes written records of religious, ritual, ceremonial, political, or scientific importance, including, but not limited to, works on papyrus, vellum or parchment, paper, or leather. Papyrus documents are often rolled and/or fragmentary. Parchment and paper documents may be single leaves or bound as scrolls or books. They may have illustrations or illuminated paintings with gold or other colors, or be otherwise embellished with colorful floral or geometric motifs. There are also examples of Korans ( Qur'ans ) and other religious and/or rare books written on leather pages. This category also includes boxes for books or scrolls made of wood or other organic materials and book or manuscript covers made of leather, textile, or metal.

1. Traditional Clothing—Traditional Albanian folk clothing including headdresses ( qeleshe, pils, Albanian hat, qylafë, kapica, langi, lëvere, kryqe ), pants and upper body covers ( fustanella, tirq, brekusha, xhubleta, mbështjellëse ), vests ( xhamadan ), belts ( brez ), socks ( çorape ), and shoes ( opinga ).

2. Religious Vestments and Textiles—In linen, silk, and wool. This category includes religious textiles and fragments from mosques, churches, shrines, tombs, and monuments, including garments, hangings, prayer rugs, and shrine covers, as well as robes, vestments and altar clothes that are often embroidered in silver and gold. Embroidered designs include religious motifs and floral and geometric designs.

This category includes weapons and armor in all materials. This includes daggers, swords, saifs, scimitars, other blades, with or without sheaths, as well as spears, firearms, and cannons. These may be inlaid with gemstones, embellished with silver or gold, or engraved with floral or geometric motifs and inscriptions. Grips or hilts may be made of metal, wood, and/or semi-precious stones, such as agate, and bound with leather. Armor consists of small metal scales, originally sewn to a backing of cloth or leather, and augmented by helmets, body armor, shields, and horse armor.

This amendment involves a foreign affairs function of the United States and is, therefore, being made without notice or public procedure under 5 U.S.C. 553(a)(1). For the same reason, a delayed effective date is not required under 5 U.S.C. 553(d)(3).

Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply.

CBP has determined that this document is not a regulation or rule subject to the provisions of Executive Order 12866 because it pertains to a foreign affairs function of the United States, as described above, and therefore is specifically exempted by section 3(d)(2) of Executive Order 12866.

This regulation is being issued in accordance with 19 CFR 0.1(a)(1) pertaining to the Secretary of the Treasury's authority (or that of his/her delegate) to approve regulations related to customs revenue functions.

Chris Magnus, the Commissioner of CBP, having reviewed and approved this document, has delegated the authority to electronically sign this document to Robert F. Altneu, who is the Director of the Regulations and Disclosure Law Division for CBP, for purposes of publication in the Federal Register .

For the reasons set forth above, part 12 of title 19 of the Code of Federal Regulations (19 CFR part 12), is amended as set forth below:

The Convention on Cultural Property Implementation Act, Public Law 97-446, 19 U.S.C. 2601 et seq. (“the Cultural Property Implementation Act”), implements the 1970 United Nations Educational, Scientific and Cultural Organization (“UNESCO”) Convention on the Means of Prohibiting and Preventing the Illicit Import, Export and Transfer of Ownership of Cultural Property (“the Convention” (823 U.N.T.S. 231 (1972)). Pursuant to the Cultural Property Implementation Act, on January 20, 2022, the United States entered into a bilateral agreement with the Federal Republic of Nigeria (“Nigeria”) to impose import restrictions on certain archaeological and ethnological material from Nigeria. This rule announces that the United States is now imposing import restrictions on certain archaeological and ethnological material from Nigeria.

Under 19 U.S.C. 2602(a)(1), the United States must make certain determinations before entering into an agreement to impose import restrictions under 19 U.S.C. 2602(a)(2). On March 9, 2021, the Acting Assistant Secretary for Educational and Cultural Affairs, United States Department of State, after consultation with and recommendation by the Cultural Property Advisory Committee, made the determinations required under the statute with respect to certain archaeological and ethnological material originating in Nigeria that is described in the Designated List set forth below in this document.

These determinations include the following: (1) That the cultural patrimony of Nigeria is in jeopardy from the pillage of certain types of archaeological material representing Nigeria's cultural heritage dating from approximately 1500 B.C. to A.D. 1770, and certain categories of ethnological material dating from approximately A.D. 200 to the early 20th century A.D. (19 U.S.C. 2606(a)(1)(A)); (2) that the Nigerian government has taken measures consistent with the Convention to protect its cultural patrimony (19 U.S.C. 2602(a)(1)(B)); (3) that import restrictions imposed by the United States would be of substantial benefit in deterring a serious situation of pillage and remedies less drastic are not available (19 U.S.C. 2602(a)(1)(C)); and (4) that the application of import restrictions as set forth in this final rule is consistent with the general interests of the international community in the interchange of cultural property among nations for scientific, cultural, and educational purposes (19 U.S.C. 2602(a)(1)(D)). The Acting Assistant Secretary also found that the material described in the determinations meets the statutory definition of “archaeological or ethnological material of the State Party” (19 U.S.C. 2601(2)).

On January 20, 2022, the United States and Nigeria signed a bilateral agreement, “Memorandum of Understanding between the United States of America and the Federal Republic of Nigeria Concerning the Imposition of Import Restrictions on Categories of Archaeological and Ethnological Material of Nigeria” (“the Agreement”), pursuant to the provisions of 19 U.S.C. 2602(a)(2). The Agreement entered into force upon signature and enables the promulgation of import restrictions on categories of archaeological material, ranging in date from approximately 1500 B.C. to A.D. 1770, and certain categories of ethnological material, ranging in date from approximately A.D. 200 to the early 20th century A.D., representing Nigeria's cultural heritage. A list of the categories of archaeological and ethnological material subject to the import restrictions is set forth later in this document.

In accordance with the Agreement, importation of material designated below is subject to the restrictions of 19 U.S.C. 2606 and § 12.104g(a) of title 19 of the Code of Federal Regulations (19 CFR 12.104g(a)) and will be restricted from entry into the United States unless the conditions set forth in 19 U.S.C. 2606 and § 12.104c of the CBP Regulations (19 CFR 12.104c) are met. CBP is amending § 12.104g(a) of the CBP Regulations (19 CFR 12.104g(a)) to indicate that these import restrictions have been imposed.

Import restrictions listed as 19 CFR 12.104g(a) are effective for no more than five years beginning on the date on which the Agreement enters into force with respect to the United States. This period may be extended for additional periods of not more than five years if it is determined that the factors which justified the Agreement still pertain and no cause for suspension of the Agreement exists. The import restrictions will expire on January 20, 2027, unless extended.

The Agreement between the United States and Nigeria includes, but is not limited to, the categories of objects described in the Designated List set forth below. Importation of material on this list is restricted unless the material is accompanied by documentation certifying that the material left Nigeria legally and not in violation of the export laws of Nigeria.

The Designated List includes archaeological and ethnological material from Nigeria. The archaeological material in the Designated List includes, but is not limited to, objects made of ceramic/terracotta, stone, metal, and organic material ranging in date from approximately 1500 B.C. through A.D. 1770. The ethnological material in the Designated List includes, but is not limited to, objects used in or associated with religious activities, part of community or ancestral shrines, and/or royal or chiefly activities, including beads and beaded garments, figures, ivory and bone, leather and parchment, masks and headdresses, metals, stone, ceramic/terracotta, wood, paintings, and other ceremonial and ritual objects from the Edo (includes Benin), Ejagham, Hausa, Mumuye, Owo, Yoruba, and other cultural and ethnic groups, ranging in date from approximately A.D. 200 through the early 20th century A.D. Dates and dimensions are approximate.

Approximate simplified chronology of well-known periods:

(a) Iron Age period (500 B.C. through A.D. 1000), including Nok (1500 B.C. through 0 B.C.), Katsina (500 B.C. through A.D. 200), Sokoto (500 B.C. through A.D. 200), Calabar (500 B.C. through A.D. 1200), and Bakor (A.D. 200 through 500).

(b) Medieval to Precolonial period (A.D. 900 through 1900), including Igbo-Ukwu (c. A.D. 900), Ife (A.D. 1100 through 1500), Esie (A.D. 1200 through 1500), and Owo (c. A.D. 1400).

(c) Colonial period (A.D. 1900 to 1960).

Archaeological material covered by this Agreement is associated with cultural groups who occupied Northern and Southern Nigeria from the Early Nok period in the Late Stone Age (1500 B.C.) through the Medieval and Precolonial periods (A.D. 1770). Examples of archaeological material covered by the Agreement include objects from well-known culture areas/archaeological sites, including yet to-be-discovered types of archaeological material.

1. Anthropomorphic Figures—Terracotta anthropomorphic figures include heads and full-length human shapes. Human figures may be natural or stylized in appearance. Anthropomorphic figures covered by the Agreement include, but are not limited to, figures from the following cultures:

a. Calabar Culture—Anthropomorphic figures from the Calabar culture were crafted from coiled clay with a coarse texture. Height varies, typically between 15 cm and 50 cm. Forms may be closed with a base, body, neck, and head. The body may resemble an elongated, globular vase with the head enclosing the rim of the vase. Horizontal bands may differentiate the base from the body, neck, and head. Bases are usually undecorated. Bodies are typically divided into vertical sections and decorated with raised patterns and shapes including basket weaves, cross hatching, incisions, herringbone, roped designs, zig zags, and others. Anthropomorphic faces are compressed, while the head/hairstyle decorations tend to be more elaborate, typically with coiled or braided designs and headgear, although some may be bald. It may be hard to distinguish male from female figures in Calabar anthropomorphic vessels.

b. Nok Culture—Anthropomorphic figures and heads from the Nok culture tend to be stylized and represent children and adults. Height varies widely from miniatures to life size. Postures vary with figures in half-kneeling, kneeling, sitting, or standing forms. Gestures include bent arms, crossed arms, holding an animal by the neck, or holding an object. Figures may have some clothing, such as belts/loincloths with creases and overlapping fabric that may be decorated with patterns and fringe; they may be elaborately adorned with representations of roped strands of beads at the abdomen, chest, and/or feet. Faces may have dented or pierced ears, lips, nostrils, and pupils; eyes are triangular or D-shaped and are disproportionally large. Eyebrows are arched. Some Nok mouths have stylized teeth. Hairstyles can be elaborate with several buns. Foreheads may have incisions, likely representing scarification. Some Nok figures may have a diseased appearance represented by facial features, including paralysis or elephantiasis. Feet are bare. Fingernails and toenails may be realistic or represented with triangular cuts on the nail bed. Many Nok figures are found in disarticulated or in fragmentary forms.

c. Ife Culture—Anthropomorphic figures and heads from the Ife culture tend to be naturalistic and made of terracotta, typically 9 cm to 35 cm tall. Ife figures tend to be symmetrical and may be freestanding. Some Ife figures may have caps or crowns in multiple tiers. Ife facial characteristics include, but are not limited to, vertical striations on the face, overhanging corners of the upper and lower eyelid, impressed corners of the mouth, and grooves around the neck.

d. Owo Culture—Anthropomorphic figures and heads from the Owo culture tend to be naturalistic and made of terracotta. Owo figures may be adorned with caps or headdresses, armbands or bracelets, belts, and/or collars. Owo figures may have triangular fingernails and toenails. Owo figures may hold decapitated or whole animals, including cocks, elephants, lizards, rams, or other animals.

e. Sokoto Culture—Anthropomorphic figures from the Sokoto culture are stylized and tend to have elongated, cylindrical bodies with molded heads. Sokoto faces have U-shaped drooping eyelids with pierced eyes and incisions that outline the eye; nostrils may be pierced, and mouths may be slightly agape. Sokoto figures may have elaborate hairstyles with several buns and beards. Navels are prominent and herniated. Figures may have attached and bent arms, and may be holding objects such as adzes, staffs, or weapons. Figures may be wearing banded necklaces with pendants.

f. Katsina Culture—Anthropomorphic figures from the Katsina culture are stylized. Katsina figures are often attached to the top of a globular jar or bell-shaped urn. Katsina positions often have hands resting on knees. Heads tend to wear caps.

2. Zoomorphic Figures—Figures in the shape of animals made from terracotta/fired clay include freestanding whole figures and animal heads. Figures may be stylized or naturalized. Animals represented may include, but are not limited to, apes, chameleons, dogs, frogs, goats, leopards, mudfish, monkeys, owls, rams, and snakes. Some zoomorphic figures may be perched on top of bell-shaped urns. Eyes may be carved from incisions, and there may be pierced holes for the eyes or the ear cavity.

3. Vessels—Types, forms, and decoration of terracotta vessels vary among archaeological styles over time. Shapes include bowls, bowls with lids, jars, stands, and effigy vessels. Jars often have globular bases with everted or cylindrical rims. Jars may have elongated forms. Decorative styles on the exterior of jars and stands vary and may be high- or low-relief elements. Decorative elements on the exterior of jars and stands may include low-relief elements, such as cross hatches, incisions, stamps, braided roulette, or twisted roulette. High-relief elements may include naturalistic heads, stylized heads, manillas, mudfish, other aquatic animals, snakes, sacrificial offerings, stylized architectural elements, geometric shapes, and/or stylized plant or vegetal elements. Nok vessels may have multiple anthropomorphic forms added in high-relief to the exterior of the vessel. Nok vessels may also have stylized heads carved into the exterior of the vessel with many of the same attributes found in the figures, including, but not limited to, arched eyebrows and D-shaped eyes.

4. Headrests—Terracotta headrests may have a triangular or trapezoidal shape. Headrests vary in height but are typically 12 cm tall and 45 cm in length. Headrests are composed of a base, body, neck, and curved or slightly concave horizontal top. Bases and curved horizontal tops tend to be undecorated. Bodies of headrests are elaborately decorated with elements, such as cross hatches, incisions, and/or stamps. Negative areas may be cut from the body of the headrest leaving interlocked geometric designs, including, but not limited to, chevrons or cruciforms. Headrests from the Calabar culture are a good example of the style.

5. Stelae/Funerary Urns—This category includes stelae and urns from funerary/burial contexts from the Dakakari and Katsina cultures. Urns and stelae are normally 70 cm in height. Shapes are typically complex with a circular base with vertical pillars supporting a circular or disc-shaped top. Disc-shaped tops may be decorated with a geometric design, human or animal faces, or body parts. There may be surface decoration, including incisions, piercing, stamping, or others.

1. Monoliths—Monoliths ( e.g., Akwanshi, Cross River, Ejagham, Bakor, and Ikom) are typically carved from basalt, and range in height from 50 cm to 2 m. Monoliths vary and may be carved in either a column or boulder-like form. Monoliths are carved and can have both low- and high-relief elements. Most monoliths represent male figures, but there are also examples of female and animal figures. Some monoliths have well defined facial features with beards, headdresses, or hairstyles, and may have complex, linear patterns on the face and torso. The head and torso of the monolith are often differentiated with a V-shaped groove or ridge. The torso often has a protruding navel.

2. Figures—Stone Figures ( e.g., Esie soapstone) are usually carved from steatite or soapstone. Soapstone figures come from Yoruba villages, including Esie, Ijara, and Ofaur. Figures feature animals, children, and adult figures, often seated on a stool or kneeling on a circular base. Figures are typically 20 cm to 120 cm in height. Most soapstone figures have elaborate hairstyles, conical headdresses, or helmets. Headdresses and hats may be decorated with chevrons, leaves, rosettes, and/or tassels. Facial features are naturalistic with outlined eyes, flared nostrils, and an elongated bridge on the nose. There may be striations on the face, including three striations on the temple, vertical lines on the chin, or three lines on the forehead. Female figures have three or four marks on the nape of the neck. Figures are typically adorned with necklaces and bracelets. Female figures may be holding swords and males may have quivers with arrows.

3. Beads—Stone beads may be crafted from carnelian, chalcedony, or other crypto-crystalline silicates, jasper, or quartz. Bead forms may be cylindrical, approximately 2 cm in length. Beads may also be rod or ring-shaped.

4. Axes ( nyame akuma )—Groundstone or polished axes ( nyame akuma ) have elongated forms, and, in their cross-section, are tear-drop shaped. Axes often measure 6 cm in length or less, but can measure up to 20 cm. Most groundstone axes are crafted from fine-grained volcanic or siliceous rock, sometimes with a banded pattern in the raw material.

1. Brass and Bronze—There are three types of alloys typically used in archaeological metal sculpture, vessels, and ornaments from Nigeria: (1) Copper or zinc brass; (2) leaded bronze copper with tin and lead; and (3) bronze made from copper alloys, such as copper and tin, or copper and lead. Despite this variation, Nigerian sculpture is often referred to interchangeably as brass and bronze.

a. Anthropomorphic Figures—Examples of anthropomorphic brass and bronze figures include, but are not limited to, the following:

i. Ife Brass and Bronze Figures—These include life-sized heads (sometimes with necks), masks, and full-length figures. Ife brass and bronze figures may have naturalistic features. There may be vertical striations covering the face, and in some cases on the bottom lip. There may be horizontal lines around the circumference of the neck. There may be perforations along the hairline, jawline, around the mouth, under the ears, and on the neck. Ife brass and bronze figures may have caps, crowns, or headdresses.

ii. Bronze Figures from Lower Niger Region—Bronze figures from the Lower Niger region ( e.g., Tsoede and Jebba Island) are full-length figures that typically range from 40 cm to 120 cm. Lower Niger bronzes are less naturalistic and more stylized than Ife brasses and bronzes. Figures may depict hunters, priests, warriors, or other roles. Facial features include heavily outlined and wide bulging eyes, kidney shaped mouth, compact body, wide tubular legs, and flat feet set on a pedestalled base. Lower Niger figures may have elaborate caps, crowns, or headdresses. Headdress decorations may include beads, decorative disks, horns, or small anthropomorphic or zoomorphic figures. Some carry or hold shields or staffs, or have clasped hands. Figures are often adorned with necklaces and anklets. Some may be wearing full-body tunics or belted skirts/wrappers cinched at the waist. Some may be composite of a horse and rider.

b. Zoomorphic Figures—Igbo Ukwu zoomorphic brass and bronze figures include stylized animal figures that may represent whole animals or partial animal parts, typically the head or skull. Zoomorphic figures include birds, elephants, leopards, rams, snakes, and others. Zoomorphic figures are ornately and densely decorated with encrusted designs and patterns. Geometric decorative elements can include basketweave patterns, discs, granulation, raised knobs or loops, spirals, meshwork with interlocking chevrons, metal threads, and waves. Organic decorative elements can include images of beetles, birds, eggs, flies, grasshoppers, leopards, shells, snakes, and stylized plants and flowers. Trumpet-shaped decoration can surround animal skulls.

c. Vessels—Igbo-Ukwu vessels were cast in brass and bronze using the lost-wax method ( cire perdu ). Vessels come in many forms, including open and closed forms of bowls, cups, jars, stands, and composite shapes mirroring shells and calabashes. Vessel height typically varies between 12 cm to 35 cm. Vessel decoration can vary from organic to geometric shapes. Igbo-Ukwu vessels are elaborately and ornately decorated with encrusted designs and patterns. Geometric decorative elements can include basketweave patterns, discs, granulation, raised knobs or loops, spirals, meshwork with interlocking chevrons, metal threads, and waves. Organic decorative elements can include images of beetles, birds, flies, grasshoppers, leopards, shells, snakes, and stylized plants and flowers. Decorative elements can be in either high- or low-relief forms. Some vessels may have handles on one or two sides of the body or top. Blue, red, and yellow glass beads are sometimes attached to the exterior of vessels.

d. Ornaments—Examples of ornaments include, but are not limited to, the following:

i. Igbo-Ukwu Brass and Bronze Ornaments—These include, but are not limited to, altar stands, animals, bells, eggs, fly whisks, human figures, miniature heads, pendants, scabbards, shells, and staff toppers. Decorative forms may be a composite with multiple figures (for example, a horse and rider, snake and pangolin, snake and frog, or others). Ornament sizes vary, but they are typically between 6 cm to 50 cm in height. Ornaments tend to be ornately and densely decorated with encrusted designs. Decorative elements include, but are not limited, to basketweave patterns, discs granulation, incisions, interlocking geometric designs, raised knobs or loops, and spirals. Blue, red, and yellow glass beads are sometimes attached to the exterior of ornaments.

ii. Lower Niger Ornaments—These include brass and bronze bells. Ornament sizes vary, but they are typically between 10 cm to 20 cm in height. Bells have conical shapes. Bells may have either stylized human or animal faces with flared lips, protruding eyes, and striations on the forehead and/or near the mouth. There may be ears protruding from the conical body of the bell. There may be a loop on top of the bell that allowed bells to be fastened to other objects.

2. Iron—Iron objects include, but are not limited to, ceremonial swords, jewelry ( e.g., anklets, armlets, and bracelets), knives, projectiles, staffs, and other hand-held implements.

This category includes bone, ivory, leather, textiles, and wood from archaeological contexts, such as human remains, animal remains, basketry, burial shrouds, containers, garments, figurines, textiles, tools, and vessels.

Ethnological material covered by the Agreement includes, but is not limited to, objects that were used in religious activities, part of community or ancestral shrines, and/or used in royal or chiefly activities. Objects are associated with many cultures and civilizations ranging in date from approximately 200 A.D. through the early 20th century A.D. Nigeria's cultures, cultural complexes, and polities include groups, such as the Afo, Bassa-Nge, Benin, Bokyi, Chamba, Cross River Basin Peoples, Dakakari, Edo, Ekoi, Hausa, Ibibio, Idoma, Igala, Igbo, Ijaw, Ijo, Fulani, Jukun, Kanem-Borno, Mambila, Mama, Montol, Mumuye, Nupe, Ogoni, Okpoto, Sokoto, Tiv, Wamba, Verre, and Yoruba.

Beads and beaded garments include, but are not limited to, boots, caps, crowns, dance panels, diviner's bags, garments for altar figures, gowns, footrests, leggings, fly whisks, scepters, and sheaths for ceremonial swords and other hand-held royal or chiefly implements, such as staffs used in or associated with religious activities, community or ancestral shrines, and/or royal or chiefly activities.

Figures come in many forms and were crafted from different types of material, such as terracotta/fired clay, stone, and wood. Figures tend to depict humans, human heads, and animals, and may be naturalistic or stylized. Figures include, but are not limited to, figures made by Afo artists, Chamba figures, Ekpu figures, Ibeji figures, Igbo ancestor and shrine figures, Ijo figures, Jukun figures, Mbembe figures, Ogboni figures, Oron figures, Mumuye figures, Urhobo figures, Verre figures, Yoruba figures, ecclesiastical figures, and others used in or associated with religious activities, community or ancestral shrines, and/or royal or chiefly activities. Signs of wear depend on the intended use of the object and range from well-preserved surfaces to worn and/or encrusted surfaces.

Ivory and bone objects come in many forms, including, but not limited to, altar pieces, boxes, bowls, bracelets, ceremonial swords, costume attachments, divination tappers, ecclesiastical objects, figures, gongs, horns/trumpets, masks, paddles, pendants, rattles, salt cellars, spoons, staffs, staff heads, vessels, and other objects. Ethnological objects made from ivory include Afro-Portuguese ivories, which are ornately carved and often in the form of salt cellars, trumpets, spoons, pendants, or vessels. Ivory and bone objects are typically associated with the Edo, Owo, and Yoruba cultures, and date approximately from the 15th through the 19th centuries A.D.

Secular and religious Islamic texts, manuscripts, and portions of manuscripts, including but not limited to, Qur'ans, commentaries, essays, letters, poetry, treatises, and other documents spanning the subjects of astronomy, chronicles, ethics, history, Islamic philosophy, law, literature, prophetic traditions, secret arts, Sufism, and related subjects. Books and manuscripts may be in sheets or in bound volumes, and may be decorated with colorful, geometric, or organic designs. Text is handwritten on paper and may be gathered into leather folios, and may be written in Arabic, Ajami, Hausa, or Fulfulde scripts.

Masks and headdresses were typically created in three forms: (1) Helmet-style; (2) facemasks; and (3) headcrests (worn on the top of the head). Masks and headdresses may show signs of use from being worn, used repeatedly, and fastened to the wearer. They may be crafted from brass/bronze, coconut shells, iron, ivory, leather, raffia, wood, vegetable fibers, or a combination of materials. They may be carved and ornamented with decorative and symbolic motifs. Beads, bells, and/or shells may be attached. They may be carved and decorated to represent human, animal, and composite forms ( e.g., horse and rider). Some masks, like those of the Yoruba and the Igbo region, may be painted with vibrant colors. Masks may also come in Janus style (double-sided) or plank forms. Masks may have been worn by men, women, and children. Masks may be encrusted with layers of clay, kaolin, ochre, soil, or sediment. Examples of masks include those used in or associated with religious activities and/or royal or chiefly activities, such as face masks from Bassa-Nge, Ibibio, and Yoruba, helmet masks from Ejagham, Igala, and Mambila, or crest masks or headdresses from Bokyi, Ejagham, Ekoi, Ibibio, Idoma, Igbo, Ijo, Mama, and Yoruba.

There are three types of alloys typically used in ethnological metal sculpture from Nigeria: (1) Copper or zinc brass; (2) leaded bronze copper with tin and lead; and (3) bronze made from copper alloys, such as copper and tin or copper and lead. Despite this variation, Nigerian sculpture is often referred to interchangeably as brass and bronze. Benin Bronzes are the best-known examples. Examples of Benin Bronzes includes, but are not limited to, the following:

1. Anthropomorphic Figures—Benin Bronzes come in a variety of anthropomorphic forms, including free standing heads, heads on pedestalled bases, free standing full-length human figures, and full-length human figures on pedestalled bases. Head height varies, typically between 20 cm to 55 cm. Features may be both naturalized and stylized. Heads may have a wide and cylindrical shape, cheeks may be swollen, and eyes may be enlarged. Heads have representations of regalia including tight-fitting collars that do not cover the chin or beaded collars that cover the neck and chin reaching the lower lip. Heads may have caps, conical hats, crowns, elaborate hairstyles, or helmets. Beads may hang above the eyes. Wing-like feathers and/or horizontal bars may project from the side of headgear and crowns. Full-length Benin bronze figures vary in height, typically between 40 cm and 65 cm. Full-length figures can be free standing or on a pedestalled base. The position is typically asymmetrical as some figures hold side-blown trumpets, staffs, weapons, or other objects. Figures are often adorned with necklaces, bracelets, and caps, elaborate hairstyles, helmets, or other headgear. Male figures often wear skirts/wrappers tied around the waist. Some full-length figures have “cat-whisker” scarification protruding from the mouth. Some are composite figures, such as a full-length figure of a horse and rider.

2. Zoomorphic Figures—Zoomorphic Benin bronze figures include freestanding animals and animals on pedestalled bases, including, birds, fish, horses, leopards, rams, roosters, snakes, and others. They may be stylized and include both whole and partial animal figures. Figures tend to have decorated bodies with feathers, scales, or spots. Some figures may have once been part of decorative architectural elements, including turrets. Height varies, typically from 30 cm to 60 cm. Pedestalled bases may be decorated with braided geometric and organic designs.

3. Ornaments—Benin brass and bronze ornaments include, but are not limited to, altar ornaments/stands, anklets, bells, bracelets, discs, figures, finials, flasks, hip ornaments, horns/trumpets, lamps, masks, miniature crowns, pot stands, rings, stools, staffs, and staff toppers. Ornaments were cast using the lost-wax cast method and tend to be ornately decorated with both high- and low-relief elements. Decorative elements include, but are not limited to, basketweave patterns, chains, incisions, interlocking geometric designs, organic designs, raised knobs or loops, spirals, waves, and others. Decorative forms may include human heads and full-length figures. Some ornaments may incorporate animal designs into the body of the piece with birds, crocodiles, frogs, horses, mudfish, snakes, and other animal designs.

4. Plaques—Benin bronze plaques were cast using the lost-wax method. Plaques come in rectangular, pendant, and pectoral forms. Rectangular plaques tend to be slightly taller than wider, with height varying between 40 cm to 50 cm and width varying between 30 cm to 45 cm. Pendant and pectoral plaques tend to be semicircular. The dimensions of pendant or pectoral plaques vary, typically with a height and width varying between 15 cm to 40 cm. Plaques tend to be ornately decorated with both naturalistic and stylized elements. The backgrounds may have low-relief geometric and organic elements, including circles, dots, flowers, petals, quatrefoils, and other designs. High-relief decorative elements often include a prominent full-length human figure, often flanked by two or more figures that may be smaller in size. Human figures are often adorned in ceremonial dress including anklets, armor, bracelets, decorated skirts/wrappers and tunics, necklaces, and other objects. Crowns are common on the main figure and have many of the same decorative elements as the Benin bronze memorial heads, such as feathers and horizontal bars protruding from the temple. Some human figures may have facial hair. Smaller figures may carry shields, staffs, trumpets, and other weapons. Other high-relief decorative elements include birds, crocodiles, insects, fish, snakes, trees, and others.

5. Vessels—Benin brass and bronze vessels were cast in bronze using the lost-wax method. Vessels come in many forms, including open and closed forms of bowls, lidded bowls, cups, jars, jugs, lidded jars, and stands. Sizes vary, typically between 7 cm and 40 cm. Vessels are typically elaborately decorated with high- and low-relief elements and with both naturalistic and stylized elements. The vessels' backgrounds may have low-relief geometric and organic elements, including arches, circles, dots, leaves, flowers, interlocking geometric designs, petals, quatrefoils, and other designs. High-relief elements on vessels include human and animal figures such as leopards, frogs, mudfish, snakes, snails, tortoises, and others.

This category includes iron objects, such as axes, ceremonial currency, ceremonial swords and knives, spears, staffs, swords, and other weapons used in or associated with religious activities, community or ancestral shrines, and/or royal or chiefly activities. Iron implements vary in size, typically between 30 cm and 110 cm in height. Ceremonial swords have fan-shaped blades. Blades may be curved or pointed. Axes and ceremonial currency may have simple or ornate curved blades that were not intended to be used, and may not have been created for a utilitarian purpose. Blades may have dulled edges, and forms are typically more delicate and ornate than utilitarian tools, projectiles, and weapons. While the blades are forged from iron, the hilt, pommel, and grip may be crafted from bone, brass, bronze, copper, ivory, or wood.

1. Monoliths—Monoliths ( e.g., Akwanshi, Cross River, Ejagham, Bakor, and Ikom) are typically carved from basalt, and range in height from 50 cm to 2 m. Monoliths vary and may be carved in either a column or boulder-like form. Monoliths are carved and can have both low- and high-relief elements. Most monoliths represent male figures, but there are also examples of female and animal forms. Some monoliths have well-defined facial features with beards, headdresses or hairstyles, and they may have complex, linear patterns on the face and torso. The head and torso of the monolith is often differentiated with a V-shaped groove or ridge. The torso often has a protruding navel.

2. Figures—Stone figures ( e.g., Esie soapstone) are usually carved from steatite or soapstone. Soapstone figures come from Yoruba villages, including Esie, Ijara, and Ofaur. Figures feature animals, children, and adult figures, often seated on a stool or kneeling on a circular base. Figures are typically 20 cm to 120 cm in height. Most soapstone figures have elaborate hairstyles, conical headdresses, or helmets. Headdresses and hats may be decorated with chevrons, leaves, rosettes, and/or tassels. Facial features are naturalistic with outlined eyes, flared nostrils, and an elongated bridge on the nose. There may be striations on the face, including on the temple, chin, and/or forehead. Female figures often have three or four marks on the nape of the neck. Figures are typically adorned with necklaces and bracelets. Female figures may be holding swords and males may have quivers with arrows and a helmet with a shape of a bird.

This category includes ceramic or terracotta vessels, figures, and objects used in or associated with cemeteries, religious activities, community or ancestral shrines, and/or royal or chiefly activities in Dakakari, Edo, Yoruba, and other cultures.

1. Anthropomorphic Figures—Examples include anthropomorphic figures from the Edo cultures, which tend to have both naturalized and stylized characteristics. Height varies, typically between 9 cm and 25 cm. Terracotta ceremonial or commemorative heads share similar characteristics to the anthropomorphic bronze figures described in section I.F.1. of this Designated List. Heads may have a wide and cylindrical shape, cheeks may be swollen, and eyes may be enlarged. Heads include representations of regalia including tight-fitting collars that do not cover the chin to beaded collars that cover the neck and chin reaching the lower lip. Terracotta heads may have caps, conical hats, crowns, elaborate hairstyles, or helmets. Beads or incisions may hang above the eyes. Heads may have a hollow core.

2. Zoomorphic Figures—Examples include zoomorphic figures from the Edo cultures, which tend to have stylized characteristics. Height varies, typically between 9 cm and 25 cm. Edo zoomorphic figures tend to feature singular heads of animals such as leopards, rams, or other animals. Eyes and pupils tend to be incised. Heads may have a hollow core.

3. Funerary Stelae/Figures—Funerary stelae and figures from the Dakakari culture tend to be stylized and include anthropomorphic figures, zoomorphic figures, or composite figures, such as a horse and rider. Height varies, typically between 30 cm and 50 cm. Anthropomorphic and zoomorphic figures tend to be positioned on top of a bell-shaped or spherical base. Bodies tend to be cylindrical with truncated limbs. Eyes may be represented by linear slits that puncture the terracotta, while the nostrils and mouths may be punctured with more rounded holes. Animal figures tend to have elongated, quadruped limbs.

1. Architectural Elements—This category includes doors, door fixtures, houseposts, and veranda posts from religious buildings, including churches and shrines, and royal buildings, which were used in or associated with religious activities, community or ancestral shrines, and/or royal or chiefly activities. Architectural pieces may be ornately carved with high-relief decorations.

2. Ceremonial and Religious Wood—This category includes altar pieces, altar stands, ceremonial bowls, ceremonial boxes, divination trays, divination vessels, drums, gong rasps, masquerade ornaments, missal stands, offering bowls, prayer boards, Qur'an boxes, staffs, staff heads, stools, and other objects used in or associated with religious activities, community or ancestral shrines, and/or royal or chiefly activities.

Incised, engraved, pecked, or painted drawings on natural rock surfaces. Decoration includes human figures, animal figures (in particular, cattle, sheep, and short horned bulls), and geometric symbols.

On September 9, 2021, the Silverback Pacific Company notified the Coast Guard of an intention to conduct the “Sail Grand Prix 2021” event in the San Francisco Bay. Sail Grand Prix (SailGP) is a sailing league featuring world-class sailors racing 50-foot foiling catamarans. The inaugural season started April 2021 in seven iconic cities throughout the world and is traveling to San Francisco Bay in March 2022. In response, on December 15, 2021, the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Special Local Regulation; Sail Grand Prix 2021 Race Event; San Francisco, CA” (86 FR 71412). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this event. During the comment period that ended January 18, 2022, we received one comment.

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 contrary to public interest because action is needed to protect personnel, vessels, and the marine environment from the potential hazards associated with Sail Grand Prix 2021 event beginning March 24, 2022.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port (COTP) San Francisco has determined that these regulations are needed to keep persons and vessels away from the sailing race vessels, which exhibit unpredictable maneuverability, and have demonstrated likelihood during the simulation of racing scenarios for capsizing. This special local regulation will help prevent injuries and property damage caused upon impact by these fast-moving vessels. The provisions of this temporary special local regulation do not exempt racing vessels from any federal, state, or local laws or regulations, including Nautical Rules of the Road.

Per 33 CFR 100.35, the Coast Guard District Commander may promulgate certain special local regulations deemed necessary to ensure safety of life on the navigable waters immediately before, during, and immediately after an approved regatta. Pursuant to 33 CFR 1.05-1(i), the Commander of Coast Guard District 11 has delegated to the COTP San Francisco the responsibility of issuing such regulations.

As noted above, we received one comment on our NPRM published December 15, 2021. The comment was positive in nature and supported the issuance of the special local regulation as proposed. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

This rule establishes a special local regulation associated with the Sail Grand Prix 2021 race event which will be enforced from noon to 5:30 p.m. each day from March 24, 2022, through March 27, 2022. The areas regulated by this special local regulation will be east of the Golden Gate Bridge, south of Alcatraz Island, west of Treasure Island, and in the vicinity of the city of San Francisco waterfront. The Coast Guard will establish a primary race area, a spectator area, and a waterfront passage area. An image of these proposed regulated areas may be found in the docket. The special local regulation will cover all navigable waters of the San Francisco Bay, from surface to bottom, within the area formed by connecting the following latitude and longitude points in the following order: 37°48′24.3″ N, 122°27′53.5″ W; thence to 37°49′15.6″ N, 122°27′58.1″ W; thence to 37°49′28.9″ N, 122°25′52.1″ W; thence to 37°49′7.5″ N, 122°25′13″ W; thence to 37°48′42″ N, 122°25′13″ W; thence to 37°48′26.9″ N, 122°26′50.5″ W and thence along the shore to the point of beginning.

Located within this footprint, there will be four separate regulated areas: Zone “A”, the Official Practice Box Area; Zone “B”, the Official Race Box Area; Zone “C”, the spectator Area; and Zone “D”, the No Spectating or Loitering Area.

Zone “A”, the Official Practice Box Area, will be marked by colored visual markers. The position of these markers will be specified via Local Notice to Mariners at least two weeks prior to the event and via Broadcast Notice to Mariners at least seven days prior to the event. Zone “A” will be used by the race and support vessels during the official practice periods on March 24, 2022, and March 25, 2022. Zone “A”, the Official Practice Box Area, will be enforced during the official practice periods from noon to 5:30 p.m. on March 24, 2022, and from noon to 5:30 p.m. on March 25, 2022. Excluding the public from Zone “A” is necessary to provide protection from the operation of the high-speed sailing vessels within this area.

Zone “B”, the Official Race Box Area, will be marked by 12 or more colored visual markers. The positions of these markers will be confirmed via Broadcast Notice to Mariners at least three days prior to the event. Only designated Sail Grand Prix 2021 race, support, and VIP vessels will be permitted to enter Zone “B”. Zone “B”, the Official Race Box Area, will be enforced during the official races from noon to 5:30 p.m. on March 26, 2022, and from noon to 5:30 p.m. on March 27, 2022. Because of the hazards posed by the sailing competition, excluding non-race vessel traffic from Zone “B” is necessary to provide protection from the operation of the high-speed sailing vessels within this area.

Zone “C”, the Spectator Area, would be within the special local regulation area designated above and outside of Zone “B”, the Official Race Box Area. Zone “C” will be defined by latitude and longitude points per Broadcast Notice to Mariners. Zone “C” will be further sub-divided into three additional sub-areas: Zone “C1 East”, Zone “C1 West”, and Zone “C2”. Zone “C1 East” and Zone “C1 West” will be the general spectator areas that are open to all vessel spectators. Zone “C2” will be separately designated spectator area or areas, marked by approximately four or more colored buoys that will be managed by marine event sponsor officials. Vessels will be prohibited from anchoring within the confines of Zone “C”.

Zone “D” will be the No Loitering or Anchoring Area. This zone will allow vessels to transit in and out of marinas, piers, and vessel launch areas throughout the duration of the Sail Grand Prix event. All vessels must maintain headway and may not loiter or anchor within the confines of Zone “D”. Mariners can transit Zone “D” during the Sail Grand Prix 2021 event, decreasing the impact of the special local regulation to the San Francisco waterfront.

The duration of the establishment of this special local regulation is intended to ensure the safety of vessels in the navigable waters during the scheduled practice and race periods. This temporary special local regulation will temporarily restrict vessel traffic adjacent to the city of San Francisco waterfront in the vicinity of the Golden Gate Bridge and Alcatraz Island and prohibit vessels and persons not participating in the race event from entering the dedicated race area. The regulatory text appears at the end of this document.

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, and duration of the special local regulation. With this special local regulation, the Coast Guard intends to maintain commercial access to the ports through an alternate vessel traffic management scheme. The special local regulation is limited in duration, and is limited to a narrowly tailored geographic area with designated and adequate space for transiting vessels to pass when permitted by the COTP or a designated representative. In addition, although this rule restricts access to the waters encompassed by the special local regulation, the effect of this rule will not be significant because the local waterway users will be notified in advance via Broadcast Notice to Mariners to ensure the special local regulation will result in minimum impact. Therefore mariners will be able to plan ahead and transit outside of the periods of enforcement of the special local regulation, or alternatively, they will be able to transit the city of San Francisco Waterfront via Zone “D” with approval from the COTP or designated representative. The entities most likely to be affected are commercial vessels and pleasure craft engaged in recreational activities.

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 received no comments from the Small Business Administration on this rulemaking. 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.

This rule may affect owners and operators of commercial vessels and pleasure craft engaged in recreational activities and sightseeing for a limited duration. This special local regulation will not have a significant economic impact on a substantial number of small entities for the reasons stated in Section V.A above. When the special local regulation is in effect, vessel traffic can pass safely around the regulated area. The maritime public would be advised in advance of this special local regulation via Broadcast Notice to Mariners.

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 special local regulation that would create regulated areas of limited size and duration that includes defined regulated areas for vessel traffic to pass. It is categorically excluded from further review under paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1.

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 100 as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2020-0531 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before May 16, 2022. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2020-0531, by one of the following methods.

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

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

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

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

In the Federal Register of December 21, 2020 (85 FR 82998) (FRL-10016-93), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-11376) filed by Pyxis Regulatory Consulting, Inc., on behalf of UPL NA Inc. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of zinc stearate (CAS No. 557-05-1) when used as an inert ingredient (lubricant) in fumigant pesticide formulations at rates of no more than 6 percent by weight of the formulation when applied pre-and post-harvest to crops. That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. The Agency did not receive any substantive public comments.

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

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

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

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure to zinc stearate, including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with zinc stearate follows.

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

The acute toxicity of zinc stearate to mammals is low. The acute oral LD 50 (lethal dose) in rats is greater than 2,000 milligrams/kilogram (mg/kg). The acute dermal LD 50 in rabbits is also greater than 2,000 mg/kg, and the acute inhalation LD 50 in rats is greater than 200 mg/L. Zinc stearate is not an eye or a dermal irritant.

The repeated-dose toxicity for zinc stearate and the related compound calcium distearate in mammals is low. No adverse effects were observed in a 28-day rat study with zinc stearate, which also conducted a neurobehavioral evaluation. Also, no adverse effects were observed in a combined repeated dose with reproduction/developmental screening study in rats with calcium distearate.

No oral chronic or carcinogenicity studies are available for zinc stearate. However, there are no structural alerts for carcinogenicity for zinc stearate and there were no adverse effects observed in the available studies on related substances. There is also low concern for mutagenicity, based on negative results in an in vitro bacterial reverse mutation study on zinc stearate. No evidence of neurotoxicity or immunotoxicity was observed in the available studies.

No toxicological endpoint of concern for zinc stearate were identified in the database.

1. Dietary exposure. Although dietary exposure (food and drinking water) may occur from the proposed uses as well as existing pesticide inert uses ( e.g., flow control agent) and non-pesticide uses ( e.g., cosmetics, personal care, pharmaceuticals, plastics and coating additives) of zinc stearate, no endpoint of concern was identified. Therefore, an acute or chronic dietary exposure assessment is not necessary for zinc stearate.

2. Residential exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure. Residential exposure to zinc stearate may occur from existing and proposed pesticide inert uses as well as from non-pesticide uses (cosmetics, personal care, pharmaceuticals, plastics and coating additives) that may be used in and around the home. However, based on the absence of a toxicological endpoint of concern, a quantitative assessment for residential exposure was not performed.

3. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or exemption, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Based on the lack of toxicity in the available database, zinc stearate and its metabolites are not expected to share a common mechanism of toxicity with other substances. For the purposes of this action, therefore, EPA has assumed that zinc stearate does not have a common mechanism of toxicity with other substances.

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database unless EPA concludes that a different margin of safety will be safe for infants and children. Based on the low toxicity of zinc stearate in the available studies, EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children, and therefore conducted a qualitative assessment of zinc stearate. As part of its qualitative assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children.

Taking into consideration all available information on zinc stearate, EPA has determined that there is a reasonable certainty that no harm to the general population or any population subgroup, including infants and children, will result from aggregate exposure to zinc stearate residues. Therefore, the establishment of an exemption from the requirement of a tolerance under 40 CFR 180.910 for residues of zinc stearate when used as an inert ingredient (lubricant) in pesticide formulations at rates of no more than 6 percent by weight of the formulation in pre- and post-harvest applications to crops is safe under FFDCA section 408.

An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of zinc stearate in or on any food commodities. EPA is establishing a limitation on the amount of zinc stearate that may be used in pesticide formulations applied pre- or post-harvest. This limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. 136 et seq. EPA will not register any pesticide formulation for food use that exceeds 6 percent zinc stearate by weight in the final pesticide formulation.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4).

The Codex has not established a MRL for zinc stearate.

Taking into consideration all available information on zinc stearate, EPA has determined that there is a reasonable certainty that no harm to the general population or any population subgroup, including infants and children, will result from aggregate exposure to zinc stearate residues. Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for zinc stearate when used as an inert ingredient at no more than 6 percent by weight of the total pesticide formulation.

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

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

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

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

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

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Office of the Federal Register's e-CFR site at https://www.ecfr.gov/current/title40.

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2021-0551 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before May 16, 2022. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2021-0551, by one of the following methods:

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

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

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

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

In the Federal Register of September 22, 2021 (86 FR 52624) (FRL-8792-03-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 9F8781) by The Lubrizol Corporation, 29400 Lakeland Blvd., Wickliffe, OH, 44092. The petition requested that 40 CFR 180.1327 be amended by amending the existing exemption from the requirement of a tolerance for residues of tetraacetylethylenediamine (TAED) and its metabolite diacetylethylenediamine (DAED) by expanding it to in or on all food commodities, when used as a fungicide and bactericide in accordance with label directions and good agricultural practices. That document referenced a summary of the petition prepared by the petitioner, The Lubrizol Corporation, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the notice of filing.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Additionally, FFDCA section 408(b)(2)(D) requires that the Agency consider “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.”

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no harm to human health. If EPA is able to determine that a tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, an exemption from the requirement of a tolerance may be established.

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

TAED is an analiphatic amide that is approved as a pesticide active ingredient for food and non-food uses. It is also is listed by the Food and Drug Administration (FDA) for use as a bleaching agent in the manufacture of food-contact paper and paperboard products (21 CFR 176.170).

TAED rapidly degrades to form diacetylethylenediamine (DAED), peroxyacetic acid (PAA), and hydrogen peroxide when exposed to water. DAED is considered to be of similar or less toxicity than TAED. Hydrogen peroxide and peroxyacetic acid are exempt from the requirement of a tolerance under 40 CFR 180.1197 and 180.1196(c), respectively. Food uses for TAED in or on rice and strawberries are supported by 40 CFR 180.1327, which currently provides for an exemption from the requirement of a tolerance for residues TAED and DAED in or on rice and strawberries, when used as a fungicide and bactericide in accordance with label directions and good agricultural practices. As a non-food pesticidal use, TAED is used on various non-bearing fruit trees, ornamentals and grasses. For all uses, dietary exposure to TAED is expected to be minimal due to TAED's physical and chemical properties and ready biodegradation in the environment.

With regard to the overall toxicological profile, TAED is of minimal toxicity. Based on acute studies, TAED is of low acute oral toxicity and acute inhalation toxicity (Toxicity Category IV), low acute dermal toxicity (Toxicity Category III) and is non-irritating to the skin and eye (Toxicity Category IV). The chemical is not a skin sensitizer. DAED is considered to be of similar or less toxicity than TAED. All data requirements were satisfied by guideline studies for subchronic toxicity (90-day oral, 90-day inhalation and 90-day dermal), developmental toxicity, reproductive toxicity and mutagenicity data requirements. There were no adverse subchronic effects for any oral or dermal routes of exposure. The active ingredient was determined to be non-mutagenic, and no adverse effects were identified relative to either developmental toxicity or reproductive toxicity. Based on this toxicological profile, EPA did not identify any toxicological endpoints of concern for TAED.

No toxicological endpoint of concern has been identified for TAED or DAED.

1. Dietary exposure from food, feed uses, and drinking water. As part of its qualitative risk assessment for TAED, the Agency considered the potential for dietary exposure to residues of TAED and its degradate, DAED. EPA concludes that dietary (food and drinking water) exposures are likely to be negligible, due to the short half-life and biodegradable nature of TAED and DAED. Further, biodegradation of TAED and DAED yields the products water, nitrate, and ammonia, which are all found naturally in the environment and readily metabolized by microorganisms.

2. From non-dietary exposure. A revaluation of the risk of occupational and residential (non-dietary) exposure to TAED and DAED was not conducted at this time. Previous EPA risk assessments support the uses on currently approved TAED product labels.

3. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has not found that TAED or DAED share a common mechanism of toxicity with any other substances, and they do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed TAED and DAED do not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.

FFDCA Section 408(b)(2)(C) provides that EPA shall retain an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. An FQPA safety factor is not required at this time for TAED and its metabolite, DAED, because EPA has conducted a qualitative dietary assessment based on low toxicity and anticipated negligible exposure to the active ingredient.

Based on the available data and information, the EPA has concluded that a qualitative aggregate risk assessment is appropriate to support the pesticidal use of TAED and its metabolite, DAED, and that risks of concern are not anticipated from aggregate exposure to the substance or its metabolite, DAED. This conclusion is based on the low toxicity of the active ingredient and expected rapid degradation of TAED and DAED in the environment.

A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found within the July 22, 2021, document entitled “Human Health Dietary Risk Assessment to Support a Tolerance Exemption Amendment for Warwick AG610 (EPA Reg. No. 59825-6), Containing 92% Tetraacetylethylenediamine as its Active Ingredient.” This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES .

Based on the Agency's assessment, EPA concludes that there is reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of TAED.

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

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established an MRL for tetraacetylethylenediamine (TAED) or its metabolite diacetylethylenediamine (DAED).

Therefore, EPA is amending the currently established exemption for residues of tetraacetylethylenediamine (TAED) and its metabolite diacetylethylenediamine (DAED) to include use in or on all food commodities—no longer limiting food use to strawberries and rice, when used as a fungicide and bactericide in accordance with label directions and good agricultural practices.

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

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

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

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

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

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

The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74) (the “2015 Act”) amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410, 104 Stat. 890 (1990)), which is intended to improve the effectiveness of civil monetary penalties (CMPs) and to maintain the deterrent effect of such penalties, requires agencies to adjust the CMPs for inflation annually.

The Department of Health and Human Services (HHS) lists the CMP authorities and the amounts administered by all of its agencies in tabular form in 45 CFR 102.3, which was issued in an interim final rule published in the September 6, 2016, Federal Register (81 FR 61538). Annual adjustments were subsequently published on February 3, 2017 (82 FR 9175), October 11, 2018 (83 FR 51369), November 5, 2019 (84 FR 59549), January 17, 2020 (85 FR 2869), and November 15, 2021 (86 FR 62928).

The annual inflation adjustment for each applicable CMP is determined using the percent increase in the Consumer Price Index for all Urban Consumers (CPI-U) for the month of October of the year in which the amount of each CMP was most recently established or modified. In the December 15, 2021, Office of Management and Budget (OMB) Memorandum for the Heads of Executive Agencies and Departments, M-22-07, “Implementation of Penalty Inflation Adjustments for 2022, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015,” OMB published the multiplier for the required annual adjustment. The cost-of-living adjustment multiplier for 2022, based on the CPI-U for the month of October 2021, not seasonally adjusted, is 1.06222. The multiplier is applied to each applicable penalty amount that was updated and published for fiscal year (FY) 2021 and is rounded to the nearest dollar.

In addition to the inflation adjustments for 2022, this final rule updates the table in 45 CFR 102.3 to add references to new, applicable civil money penalty authorities that were established or implemented since the publication of the November 15, 2021 update and that are being updated in this rule. The rule also corrects several technical errors to regulatory citations in the table and updates descriptions for clarification and accuracy. The following technical errors were identified and are corrected in the table at 45 CFR 102.3:

• The citation to, and description of, 42 U.S.C. 299c-3(d) are revised for accuracy.

• The regulatory reference of 42 CFR 1003.210(a)(5) implementing 42 U.S.C. 1395cc(g) which was inadvertently omitted from the regulation and is added.

• The description of the CMP at 42 U.S.C. 1320a-7a(o) is revised for accuracy.

• The regulatory reference to 45 CFR 155.206(i)  1 implementing 42 U.S.C. 18041(c)(2)  2 which was inadvertently omitted from the regulation is added. Additionally, the amount for this CMP was not included in the 2021 inflation adjustment rule. 86 FR 62928, 62943 (Nov. 15, 2021). Thus, we are updating the inflation amount at this time.

• The first description tied to 42 U.S.C. 1395mm(i)(6)(B)(i) is revised from “is such plan” to “if such plan”.

• The regulatory reference to 85 FR 71142 (Nov. 6, 2020) implementing CARES Act, Pub. L. 116-136, section 3202(b)(2), is revised to read 45 CFR 182.70.

++ The 2022 adjusted amount is calculated by applying the 2021 multiplier to 1.06222 percent and this adjusted amount is reflected in the table of the regulation at 45 CFR 102.3.

The 2015 Act requires Federal agencies to publish annual penalty inflation adjustments notwithstanding section 553 of the Administrative Procedure Act (APA). Section 4(a) of the 2015 Act directs Federal agencies to publish annual adjustments no later than January 15th of each year thereafter. In accordance with section 553 of the APA, most rules are subject to notice and comment and are effective no earlier than 30 days after publication in the Federal Register . However, section 4(b)(2) of the 2015 Act provides that each agency shall make the annual inflation adjustments “notwithstanding section 553” of the APA. According to OMB's Memorandum M-21-10, the phrase “notwithstanding section 553” in section 4(b)(2) of the 2015 Act means that “the public procedure the APA generally requires (that is, notice, an opportunity for comment, and a delay in effective date) is not required for agencies to issue regulations implementing the annual adjustment.”

Consistent with the language of the 2015 Act and OMB's implementation guidance, the inflation adjustments set out in this rule are not subject to notice and an opportunity for public comment and will be effective immediately upon publication. Additionally, HHS finds that notice and comment procedures would be impracticable and unnecessary under the APA for making the statutorily required inflation updates to newly established penalty amounts and for the ministerial and technical changes in this rule. In addition, HHS is waiving notice and comment for the non-substantive technical corrections set out in this final rule. HHS finds good cause for issuing these changes as a final rule without prior notice and comment because these changes only update the regulation to add the new CMP authorities that will be adjusted in accordance with the 2015 Act which were implemented since the last update.

Pursuant to OMB Memorandum M-21-10, HHS has determined that the annual inflation adjustment to the civil monetary penalties in its regulations does not trigger any requirements under procedural statutes and Executive Orders that govern rulemaking procedures.

This rule is effective on the date specified in the DATES section of this final rule. The adjusted civil monetary penalty amounts apply to penalties assessed on or after date specified in the DATES section of this final rule, if the violation occurred on or after November 2, 2015. If the violation occurred before November 2, 2015, or a penalty was assessed before September 6, 2016, the pre-adjustment civil penalty amounts in effect before September 6, 2016, will apply.

Accordingly, the Department of Health and Human Services amends 45 CFR part 102 as follows:

Pursuant to 46 U.S.C. 40501(f), MTOs may make public a schedule of rates, regulations, and practice. Additionally, Congress directs the Commission to prescribe the form and manner in which MTO schedules shall be published. 46 U.S.C. 40501(g)(3). The Commission's regulations regarding MTO schedules are outlined in 46 CFR part 525. Consistent with the language in 46 U.S.C. 40501(f), part 525 states that an MTO, at its discretion, may make available to the public a schedule of its rates, regulations, and practices. Part 525 also discusses the requirements when an MTO decides to make terminal schedules available to the public.

In Fiscal Year 2021, the Commission reviewed its regulations regarding MTO schedules found in 46 CFR part 525. On September 22, 2021, the Commission issued a notice of proposed rulemaking that proposed several changes to part 525 that are neither substantive nor policy related. 86 FR 52627. The proposed revisions updated references to a Commission bureau and deleted references to outdated technology. Additionally, the FMC clarified definitions or revised them to be consistent with other parts of the Commission's regulations. The Commission requested comments on these proposed amendments.

One shipper filed comments in this docket. However, these comments, which relate to per diem charges, detention and demurrage fees, and dual transaction requirements at specific terminals, do not address the proposed revisions to part 525. The commenter neither expressed support nor opposition to the proposed part 525 revisions. Because the issues raised by the commenter are outside the scope of the proposed amendments and the rulemaking, the FMC is not making changes to the final rule based on these comments. The FMC now adopts all of the proposed amendments without substantive change in this final rule.

The proposed rule contained revisions that were not policy related and the Commission's intent was limited to modernizing outdated requirements, clarifying existing requirements and definitions, and making the existing requirements and definitions consistent with other parts of the Commission's regulations. For the reasons stated in the NPRM and described below, the Commission is adopting the revisions in the proposed rule with non-substantive changes.

The proposed rule revises references to the Shipping Act of 1984 (the Act) to remove specific cites to the Ocean Shipping Reform Act of 1998 and the Coast Guard Authorization Act of 1998 because several other laws also amend the Shipping Act of 1984. See An Act to Complete the Codification of Title 46, United States Code, “Shipping,” as Positive Law, Public Law 109-304, 120 Stat. 1485 (2006); Frank LoBiondo Coast Guard Authorization Act of 2018, Public Law 115-282, 132 Stat. 4192 (2018). These revisions affect section 525.1(a) and (c)(1). The proposed rule added clarifying language to the definition of “bulk cargo” to explain that bulk “containerized cargo tendered by the shipper” is subject to mark and count and is, therefore, subject to the requirements of this part. The proposed rule amended the definition of “forest products” to correct a typographical error.

In addition, the proposed rule revised the definition of “marine terminal operator” to mean “a person engaged in the United States in the business of providing wharfage, dock, warehouse, or other terminal facilities in connection with a common carrier[.]” This language is consistent with the statutory definition of an MTO. See 46 U.S.C. 40102(15). The proposed rule also added language to clarify that shippers or consignees who exclusively provide their own marine terminal facilities in connection with providing marine terminal services are not MTOs.

The proposed rule amended the definition of “terminal facilities” by adding “docks, berths, piers, [and] aprons” to the list of structures comprising a terminal unit. In addition, the proposed language replaces the term “water carriers” with “ocean common carriers.” As a result of these revisions, the definition of “terminal facilities” is consistent with the definition of “marine terminal facilities” in 46 CFR part 535.

The proposed rule also introduced a definition for the “United States” that is consistent with the definition found in 46 U.S.C. 114. To accommodate the new paragraph, the proposed rule renumbered paragraphs 525.1(c)(21) to (23) to be paragraphs 525.1(c)(22) to (24). Additionally, the proposed rule revised the definition of an MTO to delete “or a commonwealth, territory, or possession thereof,” because those entities are now included in the definition of “United States.”

The comments received do not address these proposed revisions.

The final rule adopts the revisions described above without change.

The proposed rule did not propose revisions to section 525.2. The comments do not address section 525.2. Thus, the final rule does not revise section 525.2.

With respect to section 525.3, Availability of marine terminal operator schedules, the proposed rule removed outdated and unnecessary language relating to accessing electronically published MTO schedules. The proposed rule deleted the terms “personal computer (PC),” “dial-up connection,” “the internet,” “Web browser,” “Telnet session,” “modem,” and any further definition or technical requirements relating to these terms. The proposed language also amended the term “URL” to mean “uniform resource locator.” The proposed rule deleted current paragraphs 525.3(c) and (e) regarding dial-up connection requirements and Commission access as the technologies referenced in those paragraphs are obsolete.

With the deletion of specific paragraphs as discussed above, the proposed rule renumbered the remaining paragraphs. With respect to current paragraph 525.3(f), the proposed rule replaces references to the “Bureau of Tariffs, Certification and Licensing,” which no longer exists, with the “Bureau of Trade Analysis” (BTA). In addition, the proposed rule also replaced “name and telephone number of firm's representative” with simply “contact information for its representative.” The proposed rule also clarifies that BTA has authority to accept submitted Form FMC-1 filings and revisions, and that the filings are pending until accepted.

With respect to current paragraph 525.3(g), the proposed rule clarified that an MTO may make available to the public its schedules and that any such schedule made available to the public is enforceable by an appropriate court as an implied contract without proof of actual knowledge of its provisions. This language is consistent with 46 U.S.C. 40501(f).

The proposed rule did not propose revisions to section 525.4. The comments do not address section 525.4. Thus, the final rule does not revise section 525.4.

The rule is not a “major rule” as defined by the Congressional Review Act, codified at 5 U.S.C. 801 et seq. The rule will not result in: (1) An annual effect on the economy of $100,000,000 or more; (2) a major increase in costs or prices; or (3) significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based companies to compete with foreign-based companies. 5 U.S.C. 804(2).

The Regulatory Flexibility Act, 5 U.S.C. 601-612, provides that whenever an agency promulgates a final rule after being required to publish a notice of proposed rulemaking under the Administrative Procedure Act (APA), 5 U.S.C. 553, the agency must prepare and make available for public comment a final regulatory flexibility analysis describing the impact of the rule on small entities, unless the head of the agency certifies that the rulemaking will not have a significant economic impact on a substantial number of small entities. 5 U.S.C. 604, 605. Accordingly, the Chairman of the Federal Maritime Commission certifies that the final rule will not have a significant impact on a substantial number of small entities. The regulated business entities that would be impacted by the rule are marine terminal operators. The Commission has determined that marine terminal operators generally do not qualify as small entities under the guidelines of the Small Business Administration (SBA). See FMC Policy and Procedures Regarding Proper Consideration of Small Entities in Rulemakings (Feb. 7, 2003), available at https://www.fmc.gov/wp-content/uploads/2018/10/SBREFA_Guidelines_2003.pdf.

Upon completion of an environmental assessment, it was determined that the proposed rule will not constitute a major Federal action significantly affecting the quality of the human environment within the meaning of the National Environmental Policy Act of 1969, 42 U.S.C. 4321 et seq., and that preparation of an environmental impact statement is not required. This FONSI will become final within 10 days of publication of this notice in the Federal Register unless a petition for review is filed by any of the methods described in the ADDRESSES section of the document. The FONSI and environmental assessment are available for inspection at the Commission's Electronic Reading Room at: https://www2.fmc.gov/readingroom/proceeding/21-06/.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) (PRA) requires an agency to seek and receive approval from the Office of Management and Budget (OMB) before collecting information from the public. 44 U.S.C. 3507. The agency must submit collections of information in proposed rules to OMB in conjunction with the publication of the notice of proposed rulemaking. 5 CFR 1320.11.

The information collection requirements in Part 525, Marine Terminal Operator Schedules, are currently authorized under OMB Control Number 3072-0061. In compliance with the PRA, the Commission submitted the proposed revised information collections to the Office of Management and Budget. Notice of the revised information collections was published in the Federal Register and public comments were invited. See 86 FR 52627 (September 22, 2021). Comments received regarding the proposed changes are discussed above. No comments specifically addressed the information collected pursuant to part 525 and no changes were made in the final rule due to public comments.

The final rule updates a reference to a Commission bureau and deletes references to outdated technology. In addition, the final rule clarifies definitions as necessary or revises them to be consistent with other parts of the Commission's regulations. The final rule does not substantively impact the information collected pursuant to part 525.

This rule meets the applicable standards in E.O. 12988 titled, “Civil Justice Reform,” to minimize litigation, eliminate ambiguity, and reduce burden. Section 3(b) of E.O. 12988 requires agencies to make every reasonable effort to ensure that each new regulation: (1) Clearly specifies the preemptive effect; (2) clearly specifies the effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct, while promoting simplification and burden reduction; (4) clearly specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. This document is consistent with that requirement.

The Commission assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda). The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda, at http://www.reginfo.gov/public/do/eAgendaMain.

For the reasons set forth above, the Federal Maritime Commission is amending 46 CFR part 525 as follows:

The Federal Maritime Commission has broad authority pursuant to 46 U.S.C. Ch. 44101 et seq. to establish rules pertaining to PVOs' financial responsibility instruments filed with the Commission. Fact Finding 30 was initiated on April 30, 2020, to investigate the impact of COVID-19 and identify commercial solutions to COVID-19 related issues that interfered with the operation of the cruise industry. Fact Finding 30: Covid-19 Impact on Cruise Industry, Interim Report: Refund Policy (July 27, 2020). This rulemaking was based on recommendations in an Interim Report issued by the Fact Finding Officer. The Commission has carefully considered all the comments it has received in an Advance Notice of Proposed Rulemaking (ANPRM), 85 FR 65020 (October 29, 2020) and a Notice of Proposed Rulemaking (NPRM), 86 FR 47441 (August 25, 2021), prior to issuing this Final Rule (FR). The NPRM contains a detailed background of this rule. See 86 FR at 47442.

On October 29, 2020, the Commission issued an Advance Notice of Proposed Rulemaking (ANPRM) to obtain comments on potential regulatory changes recommended in the Fact Finding 30 Interim Report on PVO refund policies. The proposed changes were intended to provide a clear and consistent policy toward passenger vessel ticket refunds in the case of nonperformance by the vessel operator. Specifically, the Commission recommended modifying regulations in 46 CFR part 540 to: (1) Adopt a definition of nonperformance of transportation, and (2) detail the process for obtaining refunds under the PVOs' financial responsibility instruments filed with the Commission. Subsequent to the ANPRM, the Commission received 4 sets of comments; these were from Cruise Lines International Association (CLIA); Passenger Vessel Association (PVA); The Surety & Fidelity Association of America (SFAA); and Kacie Didier. The Commission took these comments into consideration in developing recommendations which were included in the Notice of Proposed Rulemaking (NPRM).

The Commission considered the comments it received in response to the ANPRM and adjusted the proposed regulations published on August 25, 2021. In response to the NPRM, the Commission received 82 comments from interested parties. Of the comments received, six recommended changes to the proposed regulatory text and are discussed below. The 76 remaining comments detailed individual disputes between passengers and passenger vessel owners or operators but do not directly request changes to the proposed regulatory text. The Commission appreciates the examples provided and encourages passengers that have commented to utilize the tools the Commission provides in this final rule. The six comments recommending changes to the proposed rule text were filed by Alaskan Dream Cruises (ADC), CLIA, PVA, Roanoke, SFAA, and Fredric Lazarus. These comments are addressed in the discussion below.

The Commission's current regulations provide that “[n]o person in the United States may arrange, offer, advertise or provide passage on a vessel unless a Certificate (Performance) has been issued to or covers such person.” 46 CFR 540.3. Such persons must apply for a Certificate pursuant to Section 540.4, and, per Section 540.5, provide financial responsibility “in an amount determined by the Commission to be no less than 110 percent of the unearned passenger revenue of the [PVO] applicant” for the two immediately preceding fiscal years that reflect the greatest amount of unearned passenger revenue. The amount of required financial responsibility, however, is currently capped at $32 million. 46 CFR 540.9(j). This Final Rule will revise the current regulations to include the following: (1) Implementation of the process for obtaining refunds from PVO financial responsibility instruments for nonperformance of transportation, (2) addition of the definition of nonperformance and reporting requirement for instances of nonperformance of transportation, (3) revision of the definition of unearned passenger revenue, (4) publishing information on how to obtain refunds, (5) acknowledgement of mutually-agreed settlements, and (6) accommodation for PVOs that fall into the small business category.

The sample surety bond, guaranty, and escrow agreement that are set forth in the Commission's regulations are also amended. They are included in the Appendix to this final rule.

The Commission's regulations do not currently prescribe how long passengers have after nonperformance to seek a refund from a PVO's financial responsibility instrument. The Fact Finding 30 Interim Report recommended that the Commission specify that a PVO may set a reasonable deadline for passenger refund requests, but the deadline may not be less than six months after the scheduled voyage. Fact Finding 30 Interim Report at 12. The Commission proposed: (1) The passenger makes a request for a refund from the Principal in accordance with the ticket contract. If the ticket contract refund procedure provides less than 180 days to submit a claim, the financial responsibility instrument will be available after written notification to the Principal and (2) If the passenger is unable to resolve the claim within 180 days after nonperformance, as defined in 46 CFR 540.2, the passenger may submit a claim against the financial responsibility instrument per the instructions on the Commission website. The claim may include a copy of the boarding pass, proof and amount of payment, cancellation notice, and dated proof of the properly filed claim against the Principal. All documentation submitted must clearly display the vessel and voyage with the scheduled and actual date of sailing. At the discretion of the financial instrument provider, a judgment may be required prior to resolving the claim; and (3) valid claims must be paid within 90 days of submission of the claim to the financial instrument provider.

In its submitted comments, CLIA requested that the Commission change the proposed text of 46 CFR 540.9(f)(1) and (2) to read: (1) The passenger must make a written request for a refund from the PVO in accordance with the respective PVO's claims procedures; (2) In the event the passenger is unable to resolve the claim within 180 days, or such shorter refund notice period for which the PVOs claims procedure provides, after nonperformance of transportation occurs or if the claim is denied by the PVO, the passenger may submit a claim against the financial instrument as per instructions on the Commission website. The Commission has considered the proposed changes submitted by CLIA and has adopted the proposed changes with some modification. These changes will clarify that passengers must wait until (1) the PVO refund period has ended as outlined in the PVOs claims procedure before making a claim against the financial instrument, or (2) the claim has been denied by the PVO. With this minor change, the Commission adopts CLIA's recommendation.

CLIA also proposed to revise numbered paragraphs (1) and (2) of the Commission's proposed forms FMC-132(A), FMC-133(A) and “Appendix A of Escrow Agreement,” changing the language to similarly match what they proposed for 46 CFR 540.9(f)(1) and (2). The Commission concurs and makes the corresponding changes to the forms.

Congress requires that PVOs file with the Commission evidence of financial responsibility to indemnify passengers for nonperformance of transportation. 46 U.S.C. 44102. The Commission's regulations in 46 CFR 540 do not expressly define what constitutes nonperformance of transportation, but the substantive provisions and required financial responsibility instrument terms indicate that it means a PVO's failure to provide transportation or other accommodations and services subject to part 540, subpart A, 1 in accordance with the terms of the ticket contract between the PVO and passenger. See 46 CFR 540.1(a).

As discussed in the ANPRM and NPRM, the Commission sought comment on adopting a definition of nonperformance of transportation. In the ANPRM, the Commission include the following draft definition:

Nonperformance of transportation means (1) Canceling a voyage; or (2) delaying the boarding of passengers by more than twenty-four (24) hours if the passenger elects not to embark on the substitute or delayed voyage.

After considering the comments received in the ANPRM to this definition, which are discussed in the NPRM, the Commission revised the proposed definition of nonperformance of transportation as follows:

Nonperformance of transportation means cancelling or delaying a voyage by three (3) or more calendar days, if the passenger elects not to embark on the delayed voyage or a substitute voyage offered by the passenger vessel operator.

The Commission also proposed revising the language of the forms for financial responsibility instruments (surety bonds, guaranties, and escrow agreements) to reflect coverage in situations that meet the added definition. 2

PVA concurs with the Commission's change to the definition in the proposed rule from delaying the boarding of passengers by more than 24 hours to delaying the voyage by three or more calendar days because it does not believe that a 24-hour delay in sailing should constitute nonperformance of transportation. It states that the proposed rule embraces a more reasonable standard: a delay in sailing by three (3) or more calendar days, if the passenger elects not to embark on the delayed voyage or a substitute voyage.

The PVA also agrees with the change in the proposed rule excluding from the definition of “nonperformance of transportation” a scenario in which a passenger voluntarily cancels a booking at any time in advance of the scheduled sailing. It states that if the PVO's vessel in fact sails, there is no “nonperformance of transportation.” PVA believes that the proposed definition of “nonperformance” satisfactorily addresses this potential problem.

The Alaska Catamaran, LLC dba Alaskan Dream Cruises (ADC) also concurs with revised definition of nonperformance of transportation in the proposed rule because it does not believe that a 24-hour delay in sailing should constitute nonperformance of transportation. The ADC concurs with the updated definition in the proposed rule of “a delay in sailing by three (3) or more calendar days, if the passenger elects not to embark on the delayed voyage or a substitute voyage.” ADC encourages the Commission to resist suggestion to compress this standard.

The Commission took into consideration the comments of the various interested parties, and adopts a new definition of nonperformance of transportation in 46 CFR 540.2.

The adoption of the definition of nonperformance of transportation led the Commission to require PVOs to report nonperformance of transportation events to the Commission semi- annually. This reporting is necessary in order for the Commission to be responsive to the public and to provide adequate monitoring and statistical information on occurrences of nonperformance. Nonperformance of transportation events occurring between January 1 and June 30 would be reported no later than July 20 of the same calendar year, and events occurring between July 1 and December 31 would be reported no later than January 31 of the following calendar year.

Also, this final rule requires all certified PVOs to report to the Commission, as part of their semi-annual statement, instances of nonperformance of transportation. The Commission will use the information to analyze any PVO's nonperformance and monitor the rule's impact on PVOs and consumers.

Commission regulations currently state that the PVO financial responsibility instruments must provide coverage for “unearned passenger revenue,” (UPR) which is defined in 46 CFR 540.2(i) as passenger revenue received for water transportation and all other accommodations, services, and facilities relating thereto not yet performed and includes port fees and taxes paid, but excludes such items as airfare, hotel accommodations, and tour excursions. In the NPRM, the Commission proposed redefining unearned passenger revenue as passenger revenue received for water transportation and all other accommodations, services, and facilities that have not been performed by the PVO. Passenger revenue includes port fees, taxes, and all ancillary fees remitted to the PVO by the passenger. The Commission received comments from CLIA, PVA, The Roanoke Insurance Group Inc. (Roanoke) and ADC stating their concerns with revising the definition of unearned passenger revenue.

CLIA proposes that the Commission's proposed definitions of unearned passenger revenue, at 46 CFR 540.2(i), be revised by adding the words, “. . . excluding any non-refundable amounts advanced by the PVO on behalf of the passenger to unaffiliated providers of goods and services, such as payments for non-refundable airline tickets provided to the passenger.” CLIA believes the definition should exclude from ancillary fees any non-refundable payments by the PVO, which CLIA says is acting in good faith as the agent for passengers. With respect to non-refundable airfares, CLIA maintains under most airlines' policies the passenger may be able to apply a non-refundable airfare for a different travel date for the passenger's benefit for up to a year after the original scheduled flight date. CLIA further claims that while the PVO cannot legally recoup the airfare payment for the passenger, the passenger may use the ticket.

The PVA continues to urge the Commission not to amend the definition of UPR. PVA believes that broadening the definition will cause the UPR of a PVO to go up and thereby increase how much financial responsibility must be demonstrated but that it will have no consequence for a PVO that can currently take advantage of the regulatory “cap” for financial responsibility (now at $32 million). PVA asserts that for smaller PVOs for which the “cap” does not come into play, it will increase their costs for obtaining instruments attesting to their financial responsibility. More specifically, PVA states, this change will increase the costs of the five PVOs that operate “small ship” U.S.-flagged overnight cruise vessels.

The PVA further states that travel providers that offer land-based package trips with advance collection of fees for airfare, hotel accommodations, and third-party tours will not be subject to this requirement and the land-based travel companies often compete directly with “small ship” U.S-flagged PVOs in Alaska and elsewhere. PVA claims that in the rare instances of “nonperformance of transportation,” the passengers are not without remedies—the PVO is likely to provide voluntary refunds (or if the customer agrees, credits for future travel) or the customer can obtain reimbursement from a credit card company.

Roanoke believes that the expanded definition of UPR may likely cause surety companies to be more reluctant to provide larger bonds to PVOs or make them available on pricing and/or collateral terms more expensive than they would be for a smaller bond amount. The revision will cause the calculation of UPR to be a higher amount than it would be under the current rule. This higher amount means that bond, if not already at the cap, would be for a larger amount. The financial structure of the PVO, however, would remain unchanged or could be more leveraged.

Roanoke further states that the financial structure and business nature of the cruise industry requires large dollar fixed assets, large dollar capitalization (often debt many times greater than equity), and meaningful current liabilities (unearned passenger revenue) since cruises are often booked over a year in advance. This high leverage business model makes bonding expensive or difficult to obtain unless adequate collateral security is posted with the surety. In Roanoke's experience, increasing to larger bond amounts would typically mean the surety would require a higher amount of collateral and charge a higher premium than is required by smaller bond amounts under the current rule.

ADC is a member of PVA, and a portion of their submitted comments echoed exactly the comments submitted by PVA and discussed above. ADC believes that broadening the definition will cause the UPR to go up and thereby increase how much financial responsibility must be demonstrated. ADC believes this will have no consequence for a PVO that can take advantage of the regulatory “cap” for financial responsibility (now at $32 million). The ADC asserts that for smaller PVOs, the cap does not come into play, and it will increase their costs for obtaining instruments attesting to financial responsibility, at a time when they are receiving great pressure from their bonding company to reduce their bond exposure through all steps necessary.

The ADC further claims that travel providers that offer land-based package trips with advance collection of fees for airfare, hotel accommodations, and third-party tours will not be subject to this requirement; these land-based travel companies often compete directly with “small ship” U.S.-flagged PVOs. According to ADC, in the rare instances of “nonperformance of transportation,” the passengers are not without remedies as demonstrated by ADC work during 2020 when they either refunded passengers or the passengers volunteered to move their travel to a future year.

In addition, ADC stated that it is under contract with their credit card processor to hold funds received to use in the event the company is unable to refund passengers. During the COVID-19 pandemic, their credit card company increased ADC's cash on deposit from $300,000 to $2 million. ADC believes that the UPR definition in the proposed rule would significantly damage the company's ability to meet its financial obligations.

The Commission adopts the definition of unearned passenger revenue as passenger revenue received for water transportation and all other accommodations, services and facilities that have not been performed by the PVO. Passenger revenue will include port fees, taxes and all ancillary fees submitted to the PVO by the passenger. The Commission, therefore, continues to believe that to provide better protection to passengers, and because PVOs have the existing relationship with the providers of ancillary services, the PVOs should be responsible for refunding all monies collected by the PVOs for all services not yet performed.

The Commission received one comment in reference to publishing information on how to obtain refunds. The PVA commented that it agrees with the Commission's suggestion of developing a template to place on its website with instructions for how a passenger might file a claim asserting “nonperformance of transportation.”

In this final rule, the Commission is revising part 540.9 to include a new paragraph (f) describing the process a passenger can use to obtain a refund in the event of nonperformance. Also, a new paragraph (i) will require PVOs to provide clear instructions on their websites for how passengers may obtain refunds in the event of nonperformance. The Commission believes that asking PVOs to provide this type of information on their websites will provide passengers with clear and concise instructions to follow when requesting refunds for nonperformance of transportation.

The Commission will also include the PVOs' active web page address to the Commission's own website. Additionally, Form FMC-131 “Application for Certificate of Financial Responsibility” will be updated to provide a required field for PVOs to provide the web page address of their refund instructions for nonperformance of transportation.

Mutually-agreed settlements were not specifically discussed in the NPRM. However, CLIA requested as part of their comments that the Commission add a new paragraph reading, “Nothing in this rule shall be interpreted to preclude the passenger and the PVO from entering into an alternative form of compensation in full satisfaction of a required refund, such as a future cruise credit.” The Commission agrees with CLIA that the added paragraph makes it clear that claims may be resolved between the passenger and the PVO as an alternative form of compensation. The Commission's proposed definition of nonperformance does not preclude alternative forms of compensation, such as a future cruise credit. Thus, the Commission adopts CLIA's suggestion.

The Regulatory Flexibility Act analysis below suggests that the rule may have a substantial economic impact on small PVOs. The Commission has elected to delay the implementation of this rule with respect to small entities. This accommodation for small businesses will be discussed in depth in Section V, Regulatory Analyses.

CLIA recommends that passengers applying for refunds sign and submit with the application a declaration that they have not received compensation from an alternative party. CLIA believes that the following statement should be included, “Under penalty of perjury, that the passenger, to the best of his/her/their knowledge, is due the refund sought and has not recovered and will not recover any portion of the refund sought from the cruise line or any other source, such as cancellation insurance or a credit card refund, and the passenger has not accepted an alternative form of compensation from the PVO, such as a future cruise credit, in full satisfaction of the refund.” The Commission understands CLIA's concerns for possible duplicative refund claims by passengers. The Commission, however, does not regulate financial instrument providers. Financial instrument providers may follow their own claim procedure, and it is up to them whether to require the suggested declaration from passengers submitting claims.

PVA restated that it does not believe the Commission has legal authority to issue a rule on nonperformance of transportation and refund policy. PVA claims that 46 U.S.C. 44102 does not grant legal authority to the Commission to address the matter of what constitutes nonperformance. PVA further asserts the Commission lacks the legal authority to issue a rule mandating when and how passenger refunds are payable in the event of nonperformance of transportation.

The statute requires PVOs to file with the Commission evidence of financial responsibility to indemnify passengers for nonperformance of transportation. 46 U.S.C. 44102. The statute states that satisfactory evidence includes the information the Commission considers necessary and must be filed in the forms required by the Commission's regulation. 46 U.S.C. 44102 (a)-(b). Further, the Commission has broad authority to “prescribe regulations to carry out its duties and powers.” 46 U.S.C. 46105(a).

To satisfy the statutory mandate of protecting passengers from nonperformance of transportation, the Commission believes that it must clarify what constitutes nonperformance and what is UPR. Without clear definitions of those terms, the cruise industry and passengers may continue to experience confusion as to when and how to indemnify passengers for nonperformance under the submitted financial responsibility instruments. This final rule does not regulate PVOs' own practice or policy of indemnifying passengers for nonperformance. Rather, the Commission clarifies when and how nonperformance may be covered under the financial responsibility instruments that must be submitted to the Commission by PVOs. The Commission has the statutory authority to implement these changes.

SFAA recommends that the Commission add to the rule the surety's authority to require a “final court judgment” prior to paying a claim. SFAA recommends that the provision providing that authority be included in the new proposed bond form. It recommends that Commission add that authority to the Commission's regulations to make clear that only judgments finally adjudicated by a court are acceptable.

The Commission does not adopt SFAA's recommendation. The Commission believes that it is better to allow the sureties establish their own claim procedures satisfying their obligation under the surety bonds submitted to the Commission.

The Commission received a comment from Mr. Fredric Lazarus who stated that refunds should take place when (a) the passenger cancels a booking after the declaration by the Secretary of Health and Human Services of a nationwide Public Health Emergency and (b) the scheduled sailing is ultimately delayed or cancelled by the passenger vessel operator (PVO).

Presently, PVOs are required to file with the Commission evidence of financial responsibility to indemnify passengers for nonperformance of transportation. 46 U.S.C. 44102. The adopted definition of nonperformance also provides that it means cancellation or significant delay of voyages by PVOs. Passengers' own cancellation does not constitute a nonperformance by PVOs that should be covered by the PVOs financial responsibility instruments for nonperformance.

Under the Regulatory Flexibility Act (RFA), whenever an agency promulgates a final rule after being required to publish a proposed rulemaking under the Administrative Procedure Act (5 U.S.C. 553), the agency must prepare and make available a Final Regulatory Flexibility Analysis (FRFA) describing the impact of the rule on small entities, unless the head of the agency certifies that the rulemaking will not have a significant economic impact on a substantial number of small entities. 5 U.S.C. 604-605. Below is the FRFA for this final rule.

This rulemaking stems from the Commission's Fact Finding Investigation No. 30: COVID-19 Impact on Cruise Industry on PVO refund policies. Fact Finding 30's Interim Report concluded that clearer guidance is needed to determine whether a passenger is entitled to obtain a refund if a PVO cancels a voyage, makes a significant schedule change, or significantly delays a voyage. As part of the report, the Fact-Finding Officer recommended making regulatory changes with respect to the definition of nonperformance and to make clear how passengers may obtain refunds under the PVOs' financial responsibility instruments filed with the Commission.

This final rule establishes when passengers are entitled to a refund for nonperformance of transportation. First, the rule establishes a timeline for when a refund request can occur and requires PVOs to provide clear and precise instructions on how passengers may request refunds in the event of nonperformance. Second, it clarifies that nothing in the rulemaking precludes the passenger and PVO from entering into a mutually agreed settlement such as a future cruise credit. Third, it creates a small business accommodation by delaying implementation of the new UPR definition by two years for small entities. Fourth, it adds a definition of nonperformance which entitles passengers to a refund of their prepaid fares when voyages are canceled or delayed for three or more calendar days and the passenger does not opt to accept an alternative voyage. Finally, it changes the definition of UPR to include ancillary fees such as airfare, hotel accommodations, and tour excursions if the PVO offers and collects monies from the passenger for such services.

The Commission discussed comments received in response to the NPRM in Section IV above. Two commenters touched on issues related to the Initial Regulatory Flexibility Analysis (IRFA), and the commenters either are or represent small PVOs. The PVA believes that small PVOs may be disproportionately impacted by the regulation based on the regulation's broadening definition of UPR. PVA argues that by including ancillary fees for services collected by the PVO in the definition of UPR, UPR will increase. PVA states that large PVOs will not have to demonstrate any additional financial responsibility because of the cap on coverage demonstrating financial responsibility for UPR. The cap is currently set at $32 million and many large PVOs likely exceed the cap while small PVOs likely do not. PVA contends that UPR should not include ancillary fees collected by PVOs and expresses concerns companies offering financial instruments may leave the market because of the regulation. The SFAA also expressed concerns that some of the proposed changes in the regulation may reduce the number of surety companies offering financial responsibility instruments to PVOs. ADC expressed similar concerns regarding UPR. ADC believes the increased costs of instruments to demonstrate financial responsibility for UPR could be as high as $1-$1.5 million for the small family-owned business. Both PVA and ADC asked for the rule to not be adopted.

As part of the IRFA, the Commission considered alternatives for small entities including exemption from the rule, delayed compliance with the rule, and an alternative definition of nonperformance. The Commission ultimately decided the best way to balance the need for consumer protections while minimizing the impact on small entities was to delay the new definition of UPR for small entities. Therefore, the new definition of UPR created by this rulemaking will apply to small entities two years after the effective date of the regulation for all other PVOs. During this two-year period, the existing definition of UPR prior to this proposed rulemaking will remain in effect for small entities. The Commission believes the delay will lessen potentially disproportionate impacts of the regulation on small PVOs.

The Commission defines and identifies small entities according to the Small Business Administration (SBA) regulations in 13 CFR 121.201. PVOs typically fall under the classification of the North American Industry Classification System (NAICS) code 483112, Deep Sea Passenger Transportation, and under this classification, businesses with a total number of 1,500 employees or less qualify as small. PVOs operating exclusively on coastal, the Great Lakes, and inland waterways fall under NAISC codes 483114 and 483212 and qualify as small if they have a total number of 500 employees or less. Although there may be PVOs that report employees of less than 1,500, lines that are subsidiaries of much larger companies would not qualify as small entities for the purpose of receiving regulatory relief under the RFA. See 13 CFR 121.106(b).

As noted above, small PVOs expressed concerns about the regulation increasing the costs of financial responsibility instruments to demonstrate financial responsibility for nonperformance. Part of the concern is the uncertainty around how financial responsibility products will be priced given the expanded definition of UPR and new definition of nonperformance. A two-year delay of the new definition of UPR for small PVOs will allow the market for financial responsibility instruments to adjust. Providers of such financial responsibility instruments can analyze how the new definitions of UPR and nonperformance will impact large PVOs and better price such products for small PVOs after the delay. Large PVOs are likely better able to absorb potential costs of the regulation due to larger volume of sales, likely higher cash reserves, and the monetary cap on the amount of financial responsibility for nonperformance. The two-year delay will also allow small PVOs the chance to have two full seasons of operation to adjust to the coming regulatory changes. Small PVOs will have the opportunity to evaluate their business practices for potential changes that may make it less costly to comply with the regulation's requirements and learn from changes already implemented by large PVOs.

As part of the IRFA, the Commission estimated the number of small entities, small PVOs, to which the proposed rule would apply. The same methodology from the IRFA was used for the FRFA. The Commission does not believe market conditions have changed to impact the number of small PVOs nor has the regulation changed enough between the IRFA and the FRFA that additional small PVOs would be impacted.

The SBA has established regulations to determine whether businesses qualify as small entities. 13 CFR part 121. The regulations use the NAICS with codes and descriptions to classify businesses and measure their size by either annual receipts (gross annual revenue) or number of employees. See 13 CFR subpart A—Size Eligibility Provisions and Standards (January 1, 2020). The calculation of total annual receipts or number of employees for the purpose of determining the size of a business includes those of the business itself plus those of its domestic and foreign affiliates. See 13 CFR 121.104 and 121.106.

The final rule modifies the regulations in 46 CFR part 540 governing evidence of PVOs financial responsibility for nonperformance of transportation. The regulated businesses that the rule applies to are PVOs. At present, there are a total of 43 PVOs with certificates of financial responsibility for nonperformance issued by the Commission. Pursuant to the SBA regulations in 13 CFR 121.201, PVOs fall under the classification of NAICS codes 483112, 483114, and 483212. For Deep Sea Passenger Transportation, businesses with a total number of 1,500 employees or less qualify as small. For coastal, the Great Lakes, and inland waters passenger transportation, businesses with a total of 500 employees or less qualify as small. Accordingly, the Commission estimates that 14 out of the 43 PVOs (or 33 percent) qualify as small businesses under the size standard of the SBA. While there may be PVOs that report employees of less than 1,500 or 500 depending on where the PVO operates, lines that are subsidiaries of much larger companies would not qualify as small entities for the purpose of receiving regulatory relief under the RFA. See 13 CFR 121.106(b).

The Commission estimates the total annual cost of this final rule to the Federal government to be $145,356, offset by the collection of $64,482 in filing fees, for a net annual cost of $80,874.

The final rule would require that PVOs submit additional semi-annual reports on their instances of nonperformance. The estimated annual cost of the additional reports would be $41,670.

As part of the IRFA, the Commission discussed the types of costs likely to be incurred by PVOs and the challenges associated with accurately quantifying these costs. The Commission sought comments on additional data and methods that could help quantify compliance costs. ADC was the only commenter who responded with an estimate of compliance cost and believes the increased costs of instruments to demonstrate financial responsibility for nonperformance could be as high as $1-$1.5 million for their small family-owned business.

In the IRFA, the Commission discussed what it believes to be the current costs to demonstrate financial responsibility for nonperformance. Based on interviews with PVOs as part of the investigation in Fact Finding No. 30 and its additional research, the Commission estimates the cost of premiums for nonperformance coverage to range from $75,000 for the smallest of PVOs to around $600,000 for the largest. The total cost of current nonperformance coverage for all PVOs is estimated to be around $9,830,000. The Commission believes the regulation may increase the cost of nonperformance coverage to PVOs by 25 percent due to the change in the definition of nonperformance and UPR. The Commission estimates the percentage increase in premiums based on discussions it had with members of the financial services industry. Assuming a 25 percent increase, nonperformance coverage would increase by $2,457,500 to a total of $12,287,500. Breaking down the costs increases by size of PVOs, the total increase for small PVOs would be $425,000 for a total cost of $2,125,000 and for large PVOs would be $2,032,500 for a total cost of $10,162,500.

Determining exactly how much premiums will rise as a result of this regulation is difficult. Several factors impact the cost of premiums such as the incidence rate of nonperformance, how many customers would choose refunds over future cruise credits, and the total amount of ancillary fees collected by PVOs under the new definition of UPR. While the Commission was able to find data on rates of nonperformance, it was not able to find the other types of data necessary to fully quantify the costs of the regulation on PVOs. To minimize potential impacts to small PVOs, the Commission decided to delay compliance with the regulation for small PVOs. Based on the delay, the increase in the cost of premiums for small PVOs may be less than the initially estimated 25 percent increase.

As part of complying with the RFA, the Commission estimated the number of small entities that would be impacted by this rulemaking. The Commission was not able to ascertain that the proposed rule would not have a significant economic impact on a substantial number of small entities and thus provided an IRFA in the NPRM. As part of the IRFA, the Commission considered three alternatives for small entities including exemption from the regulation, delayed compliance with the regulation, and a separate definition of nonperformance with a longer time period. The Commission decided that the best way to minimize the economic impacts on small entities while maintaining consumer protections would be to delay for two years the new definition of UPR in the rulemaking for small entities. Small entities will have two additional years before they have to comply with the new definition of UPR during which time they will have the opportunity to better understand and adjust to how the new definition will impact their businesses. The Commission believes the delay will lessen potential impacts stemming from the regulation on small entities.

The Commission's regulations categorically exclude certain actions rulemakings from any requirement to prepare an environmental assessment or an environmental impact statement because they do not increase or decrease air, water or noise pollution or the use of fossil fuels, recyclables, or energy. 46 CFR 504.4. The final rule discusses amendments to Commission's program for certifying the financial responsibility of PVOs. This rulemaking thus falls within the categorical exclusion for “[c]ertification of financial responsibility of passenger vessels” under 46 CFR 504.4(a)(2). Therefore, no environmental assessment or environmental impact statement is required.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) (PRA) requires an agency to seek and receive approval from the Office of Management and Budget (OMB) before collecting information from the public. 44 U.S.C. 3507. The agency must submit collections of information in proposed rules to OMB in conjunction with the publication of the notice of proposed rulemaking. 5 CFR 1320.11.

The information collection requirements in part 540 are currently authorized under OMB Control Number 3072-0012. In compliance with the PRA, the Commission submitted the proposed revised information collection to the Office of Management and Budget. Notice of the revised information collections was published in the Federal Register and public comments were invited. See 86 FR 47441 (Aug. 25, 2021).

No comments specifically addressed the revised information collection in part 540.

The Commission will ensure that any proposed or final rule issued in this proceeding meets the applicable standards in E.O. 12988 titled, “Civil Justice Reform,” to minimize litigation, eliminate ambiguity, and reduce burden.

The Commission assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda). The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda, available at http://www.reginfo.gov/public/do/eAgendaMain.

For the reasons stated in the preamble, the Federal Maritime Commission amends 46 CFR part 540 as follows:

To ensure that regulations remain current and effective for their intended purpose, agencies periodically review and propose amendments to their regulations. Within this context, FRA reviewed its 49 CFR part 214-Railroad Workplace Safety regulations. As a result of this review, on December 11, 2020, FRA published a notice of proposed rulemaking (NPRM) proposing two amendments to subparts C and D of part 214 addressing Roadway Worker Protection and On-Track Roadway Maintenance Machines and Hi-Rail Vehicles, respectively. 85 FR 79973. First, FRA proposed to revise § 214.322 ( Exclusive track occupancy, electronic display ) to allow the use of alternative cybersecurity standards for electronic display systems used to view track authority information. Second, FRA proposed to revise § 214.505 ( Required environmental control and protection systems for new on-track roadway maintenance machines with enclosed cabs ) to exempt certain remotely operated maintenance machines from existing HVAC requirements.

FRA believes these provisions provide flexibility to allow for the incorporation of new and future technological advances that may further improve safety. FRA received two comments, both supporting the NPRM's proposals. Accordingly, in this final rule, FRA is adopting the NPRM's proposed amendments to part 214 as proposed. 1 Given that this final rule will relieve current regulatory restrictions, in accordance with 5 U.S.C. 553(d)(1), it is effective upon its publication in the Federal Register .

FRA estimates that railroads would experience approximately $5,900 in paperwork reduction benefits over the ten-year period of this analysis. The present value (PV)  2 of these paperwork reduction benefits, when discounted at 3- and 7-percent, is approximately $5,000 and $4,100, respectively. The annualized paperwork reduction benefits are estimated to be approximately $590 at both discount rates. The table below presents the estimated 10-year total paperwork reduction benefits associated with the final rule.

Because this final rule provides railroads the flexibility to utilize alternative cybersecurity standards for electronic display systems at their discretion, and codifies an existing waiver, FRA concludes that there are no associated costs.

As noted above, FRA received two comments in response to the NPRM, both supportive of the NPRM's proposals.

The Association of American Railroads and the American Short Line and Regional Railroad Association jointly filed a comment concurring with both NPRM proposals. Regarding FRA's proposal to revise § 214.322, the joint comment stated: “Standards incorporated by reference pose challenges both for railroads and regulators alike as they often quickly become outdated. FRA's approach [in the NPRM] does not substantively change the electronic authentication technology that can be used by railroads and avoids the need for unnecessary waivers from obsolete standards.”

The second comment, from a member of the public, expressed support for the NPRM's proposals, noting that the proposals would allow for the utilization of new technology and improve safety.

As explained in the NPRM, when a roadway worker or work group establishes exclusive track occupancy working limits, and an electronic display device is used to view track authority information for that worker or work group, § 214.322(h) requires the device to provide “Level 3 assurance” as defined by the security standards of the National Institute of Standards and Technology (NIST) Special Publication 800-63-2, Electronic Authentication Guideline, “Computer Security,” August 2013 (2013 Standard). “Level 3 assurance” means the display devices must provide multi-factor remote network authentication (for example, a password or a biometric factor, such as a fingerprint, used in combination with a software or hardware token).

As also noted in the NPRM, since adoption of § 214.322(h), NIST has updated its computer security standards several times. See 85 FR 79975 (identifying updates to the 2013 Standard). Further, FRA recognizes that as cybersecurity standards continue to change over time, other standards may also provide multi-factor authentication. Accordingly, FRA proposed to provide additional flexibility for meeting the electronic authentication requirements of § 214.322(h) by adding a new paragraph (i) to the section. As proposed and adopted in this final rule, new paragraph (i) provides that paragraph (h)'s requirements may be satisfied so long as an electronic display system uses multi-factor authentication.

As discussed in detail in the NPRM, FRA may waive compliance with its regulations if the waiver is “in the public interest and consistent with railroad safety.” 49 U.S.C. 20103(d); see also 49 CFR 1.89(a). As also noted in the NPRM, activity under a waiver of regulatory compliance may generate sufficient data and experience to support an expansion of its scope, applicability, and duration.

As also explained in the NPRM, in 2008, FRA granted a waiver from the environmental control requirements of § 214.505(a) (such as heating, air conditioning, and ventilation systems) to Harsco Track Technologies, a railroad equipment manufacturer for a newly developed roadway maintenance machine (RMM) designed to function without a dedicated operator located on the machine. See FRA-2008-0070 (available at www.regulations.gov ). Railroads have safely operated equipment subject to this waiver since 2008 and the waiver has been continually renewed. Accordingly, in this final rule, FRA is adopting the NPRM's proposal to incorporate the provisions of this waiver into regulation in new paragraph (i) of § 214.505.

As discussed above and in more detail in the NPRM, this final rule adds a new paragraph (i) to § 214.322. New paragraph (i) allows the use of alternative electronic security standards that provide multi-factor authentication, other than the currently required 2013 NIST Standard. With this flexibility to use alternative standards, FRA expects industry may be able to use new methods of electronic authentication that are more secure than those described by the 2013 Standard; more secure authentication methods in turn would make it more difficult for any malicious actors to access track authority information, and thus more difficult to interfere with roadway work. FRA therefore believes this amendment in particular could lead to increased safety for roadway workers.

Because FRA is adopting the proposed amendment to § 214.322 exactly as proposed in the NPRM, FRA refers readers to the section-by-section discussion in the NPRM for a more detailed discussion of this revision.

As discussed above and in more detail in the NPRM, this final rule adds a new paragraph (i) to § 214.505. New paragraph (i) exempts certain remotely operated RMMs from existing HVAC requirements.

The substance of the amendment adopted in the final rule is the same as that proposed in the NPRM; however, FRA has decided to use the term “remotely operated” instead of “drone” when describing the RMMs at issue, to avoid confusion with the usage of the term “drone” in other contexts. Because FRA is otherwise adopting the proposed amendment to § 214.505 exactly as proposed in the NPRM, FRA refers readers to the section-by-section discussion in the NPRM for a more detailed discussion of this revision.

FRA has analyzed this final rule in accordance with Section 3(f) of Executive Order 12866, “Regulatory Planning and Review” and determined that it is not a significant rule.

FRA is revising its regulations governing the minimum safety requirements for railroad workplace safety. These changes amend part 214 to permit the use of alternative security standards for electronic display systems used to view track authority information in § 214.322, and, consistent with an existing waiver, exempt certain remotely operated RMMs from environmental control requirements in § 214.505(a), which include heating, air conditioning, and ventilation systems.

Section 214.322(h) requires that electronic display systems used to view track authority information meet the security standards defined by NIST Special Publication 800-63-2, Electronic Authentication Guideline, “Computer Security,” August 2013. FRA is allowing electronic display systems subject to § 214.322 to use alternative standards for electronic authentication, provided those systems require stringent identity proofing through multi-factor authentication. FRA expects no additional costs for this requirement as it is simply adding flexibility.

As discussed above, in 2008, FRA approved Harsco's waiver petition for a five-year period with conditions and has since continually renewed the waiver. FRA expects no additional costs for this requirement because FRA is codifying a long-standing waiver.

The final rule will be beneficial for regulated entities seeking to use electronic display systems that meet alternative cybersecurity standards for electronic authentication and provide a comparable or better level of identity proofing and digital authentication as that required by the 2013 NIST Standard. The final rule will also reduce the paperwork burden on regulated entities by providing relief from submitting waivers to FRA for the use of certain roadway maintenance machines.

FRA has estimated that paperwork reduction benefits of this final rule will result due to waiver codification, as the final rule will reduce the need for industry to submit waivers. These estimates assume that, without the final regulation, Harsco Track Technologies will continue submitting a petition to extend the waiver every five years. The last renewal was approved in 2018. To date, Harsco has been the sole entity requesting this waiver from FRA, and FRA does not expect any other entities to apply for similar waivers over the period of analysis.

FRA assumes that the cost for Harsco to prepare and submit each waiver would be approximately the same as it is for FRA to process it. To calculate the paperwork reduction benefits associated with this waiver, FRA estimated the labor hours required for FRA to review and approve each waiver. Table V-1 below displays the breakdown of the waiver review and submission cost for each waiver.

For purposes of estimating waiver costs for this analysis, FRA estimates the associated renewals that would occur over the next 10 years. Table V-2 shows the total paperwork reduction benefits for regulated entities to review and submit waivers to FRA.

The final rule provides relief to regulated entities by allowing the use of alternative standards for electronic display systems to comply with § 214.322(h) and by not having to submit waivers to FRA. An alternative to the final rule would be to maintain the status quo.

If FRA does not modify § 214.322, entities will continue to use the 2013 NIST Standard as the standard for securing and transmitting data for electronic display systems. Although this standard is safe, FRA recognizes that updated standards after the 2013 NIST Standard could allow the industry to adopt newly developed technologies and methods of data transmission that are still compliant with § 214.322(h) while providing comparable, or better, levels of security.

FRA views the remotely operated RMMs subject to the existing waiver as an example of using emerging modern technology to make railroad roadway maintenance safer and more efficient. FRA has verified that waivers allowing remotely operated RMMs do not negatively impact safety because FRA has not seen an adverse impact to safety while railroads have been operating under this waiver. Therefore, issuing this final rule removes unnecessary paperwork burdens arising from avoiding petitioning for and processing waivers.

FRA has estimated the paperwork reduction benefits of this final rule and displayed them in the table below.

As noted in the table above, FRA estimates the total paperwork reduction benefits for this final rule to be approximately $5,000 (PV, 3-percent) and $4,100 (PV, 7-percent). The annualized paperwork reduction benefits are estimated to be approximately $590 (PV, 3-percent) and $590 (PV, 7-percent).

When an agency issues a rulemaking proposal, the Regulatory Flexibility Act requires the agency to “prepare and make available for public comment an initial regulatory flexibility analysis” which will “describe the impact of the proposed rule on small entities.” 5 U.S.C. 603(a). Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities. FRA certified this rule in the proposed stage. FRA requested comments regarding the certification and received no comments.

This final rule directly affects all railroads, of which there are approximately 746 on the general system, and FRA estimates that approximately 93 percent of these railroads are small entities. Therefore, FRA has determined that this final rule will have an impact on a substantial number of small entities.

However, FRA has determined that the impact on entities affected by the final rule will not be significant. The effect of the final rule will be to allow railroads the flexibility to choose the optimal electronic display equipment currently in the market, with the required level of security, without having to notify or seek approval from FRA. Further, equipment manufacturers will no longer need to seek FRA approval to forego HVAC systems on a remotely operated piece of equipment, consistent with the established safety of a longstanding waiver. FRA expects the impact of the final rule will be a reduction in the paperwork burden for railroads and manufacturers, as well as future benefits from allowing continually advancing security standards to be incorporated without a regulatory change. FRA asserts that the economic impact of the reduction in paperwork, if any, will be minimal and entirely beneficial to small railroads. Accordingly, the FRA Administrator hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities.

FRA is submitting the information collection requirements in this final rule to the Office of Management and Budget (OMB) for approval under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, et seq. The sections that contain the final and current information collection requirements and the estimated time to fulfill each requirement are as follows:

The purpose of this direct final rule is to notify the public that we are revising: (1) The List of Endangered and Threatened Wildlife in title 50 of the Code of Federal Regulations (CFR) at § 17.11(h) (50 CFR 17.11(h)) to reflect the scientifically accepted taxonomy and nomenclature of four freshwater mussel species listed under section 4 of the Act (16 U.S.C. 1531 et seq. ). These changes reflect the most recently accepted common and scientific names in accordance with 50 CFR 17.11(b) and (c). We are also updating the nomenclature for one of the species at 50 CFR 17.85.

We are publishing this rule without a prior proposal because this is a noncontroversial action that is in the best interest of the public and should be undertaken in as timely a manner as possible. This rule will be effective, as published in this document, on the effective date specified in DATES , unless we receive significant adverse comments by the comment due date specified in DATES . Significant adverse comments are comments that provide strong justification as to why our rule should not be adopted or why it should be changed.

If we receive significant adverse comments regarding the taxonomic changes for any of these species, we will publish a document in the Federal Register withdrawing this rule for the appropriate species before the effective date, and, if appropriate, we will publish a proposed rule to initiate promulgation of those changes to 50 CFR 17.11(h).

You may submit your comments and materials regarding this direct final rule by one of the methods listed in ADDRESSES . Please include sufficient information with your comment that allows us to verify any scientific or commercial information you include.

We will post all comments on https://www.regulations.gov. This generally means that we will post any personal information you provide us. Before including your address, phone number, email address, or other personal information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Comments and materials we receive, as well as supporting documentation we used in preparing this direct final rule, will be available for public inspection on the internet at https://www.regulations.gov or by appointment, during normal business hours at the U.S. Fish and Wildlife Service location listed above in FOR FURTHER INFORMATION CONTACT . Please note that comments posted to https://www.regulations.gov are not immediately viewable. When you submit a comment, the system receives it immediately. However, the comment will not be publicly viewable until we post it, which might not occur until several days after submission. Information regarding this rule is available in alternative formats upon request (see FOR FURTHER INFORMATION CONTACT ).

Sections 17.11(c) and 17.12(b) of title 50 of the CFR direct us to use the most recently accepted scientific name of any species that we have determined to be an endangered or threatened species. Using the best available scientific information, this direct final rule documents taxonomic changes of the scientific names to four entries under “Clams” on the current List of Endangered and Threatened Wildlife (“List”; 50 CFR 17.11(h)). This rule also makes slight modifications to two common names, and those changes have the result of changing the placement of these species on the List. The basis for these taxonomic changes is supported by published studies in peer-reviewed journals. Accordingly, we revise the common and scientific names of these species under section 4 of the Act (16 U.S.C. 1531 et seq. ) as follows:

The scientific name change of Epioblasma curtisii (Curtis pearlymussel) from Epioblasma florentina curtisii is supported by phylogenetic analyses, its distinctive shell morphology, and distinct geographical range. These findings support the elevation of curtisii from subspecies to species (Williams et al. 2017, p. 48). To the extent practicable, the Service relies on the Integrated Taxonomic Information System (ITIS) to determine a species' scientific name. ITIS incorporates the naming principles established by the International Code of Zoological Nomenclature, produced by the International Commission on Zoological Nomenclature, an organization that provides and regulates a uniform system of zoological nomenclature. While ITIS is a reliable database source of taxonomic information, in this instance ITIS is incomplete. The junior synonym, Epioblasma florentina curtisii, is considered to be invalid in ITIS. Upon review of ITIS's underlying data, we consider the information that displays the scientific name for Curtis pearlymussel to be incomplete as no valid name is provided for the species. The Service finds that the Curtis pearlymussel should be recognized as Epioblasma curtisii and is a valid listable entity. This species will continue to be listed as endangered, and no other aspect of the entry for this species in 50 CFR 17.11(h) will change as a result of this rule.

The scientific name change of Epioblasma obliquata (purple cat's paw pearlymussel) from Epioblasma obliquata obliquata is supported by phylogenetic analyses, its distinctive shell morphology, and distinct geographical range. These findings support the elevation of obliquata from subspecies to species (Williams et al. 2017, p. 48). In ITIS, Epioblasma obliquata is the accepted scientific name of purple cat's paw pearlymussel. ITIS includes an additional common name for Epioblasma obliquata, catspaw, which is recognized by species experts as an alternate common name. This species will continue to be listed as endangered, and no other aspect of the entry for this species in 50 CFR 17.11(h) will change as a result of this rule.

In addition to the listing of purple cat's paw pearlymussel in § 17.11(h), this species is also included in a rule that sets forth provisions for a nonessential experimental population of 17 mollusks in the Tennessee River at § 17.85. Therefore, we are also revising 50 CFR 17.85(a) to change the species' name in those regulations.

The scientific name change of Epioblasma perobliqua (white cat's paw pearlymussel) from Epioblasma obliquata perobliqua is supported by phylogenetic analyses, its distinctive shell morphology, and distinct geographical range. These findings support the elevation of perobliqua from subspecies to species (Williams et al. 2017, p. 48). While the Service often relies on ITIS as a reliable database source of taxonomic information, in this instance ITIS is incomplete. The junior synonym, Epioblasma obliquata perobliqua, is considered to be invalid in ITIS. Upon review of ITIS's underlying data, we consider the information that displays the scientific name for white cat's paw pearlymussel to be incomplete as no valid name is provided for the species. ITIS includes an additional common name for white cat's paw pearlymussel, white catspaw, which is recognized by species experts as an alternate common name. The Service finds that the white cat's paw pearlymussel should be recognized as Epioblasma perobliqua and is a valid listable entity. This species will continue to be listed as endangered, and no other aspect of the entry for this species in 50 CFR 17.11(h) will change as a result of this rule.

The scientific name change of Epioblasma rangiana (northern riffleshell) from Epioblasma torulosa rangiana is supported by phylogenetic analyses and the lack of intergradation between E. t. torulosa and E. t. rangiana. These findings support the elevation of rangiana from subspecies to species (Cummings and Berlocher 1990, p. 92; Williams et al. 2017, p. 48). Epioblasma rangiana is the accepted scientific name of northern riffleshell in ITIS. This species will continue to be listed as endangered, and no other aspect of the entry for this species in 50 CFR 17.11(h) will change as a result of this rule.

A complete list of the referenced materials is available at https://www.regulations.gov at Docket No. FWS-R3-ES-2022-0006 or upon request from the U.S. Fish and Wildlife Service (see FOR FURTHER INFORMATION CONTACT ).

For the reasons given in the preamble, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:

The New England Fishery Management Council manages a complex of seven skate species (barndoor, clearnose, little, rosette, smooth, thorny, and winter skate) in the New England and Mid-Atlantic regions under the Northeast Skate Complex Fishery Management Plan (FMP). Skates are harvested and managed in two different fishery sectors, one for food (the wing fishery) and one for bait used in other fisheries (the bait fishery). The FMP requires the review and specification of an acceptable biological catch (ABC), annual catch limit (ACL), annual catch target (ACT), fishery-level total allowable landings (TAL) limit, separate TALs for the wing and bait fisheries, and other management measures, as needed, for up to two fishing years at a time. This action implements skate specifications for the 2022 fishing year, and projects specifications for 2023, as recommended by the Council.

The proposed rule for this action published in the Federal Register on January 18, 2022 (87 FR 2587), and comments were accepted through February 17, 2022. NMFS did not receive any comments from the public during this period. Additional background information regarding the development of these specifications was provided in the proposed rule and is not repeated here.

This action implements the Council's recommended 2022 and projected 2023 skate catch specifications (Table 1), as outlined in the proposed rule. These specifications increase the ABC by 14 percent and annual quotas for both the wing and bait fisheries by 18 percent in fishing year 2022. Specifications for fishing year 2023 are projected to be unchanged from 2022.

All other fishery management measures, such as trip limits, remain unchanged under this action. The Council will review the projected specifications for fishing year 2023 in light of any new information to determine if any changes need to be made prior to their implementation. NMFS will publish a notice prior to the 2023 fishing year to confirm these limits as projected or propose any necessary changes.

The public comment period for the proposed rule ended on February 17, 2022. NMFS received no comments from the public during this period.

There are no changes from the proposed rule.

The NMFS Administrator, Greater Atlantic Region, has determined that these specifications are necessary for the conservation and management of the Northeast skate fishery, and that it is consistent with the Northeast Skate Complex FMP, other provisions of the Magnuson-Stevens Act, and other applicable laws.

This final rule is exempt from review under Executive Order 12866 because the action contains no implementing regulations.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification, and the initial certification remains unchanged. As a result, a final regulatory flexibility analysis was not required and none was prepared.

This final rule does not duplicate, conflict, or overlap with any existing Federal rules.

This action contains no information collection requirements under the Paperwork Reduction Act of 1995.