Through its terms and conditions of its grant awards, the EAC requires grant award recipients and sub-recipients to abide by all federal financial assistance requirements, including 2 CFR part 200. The EAC already has regulations adopting 2 CFR part 180, which can be found at 2 CFR part 5800.

On April 4, 2024, the Office of Management & Budget (OMB) issued memorandum M-24-11, Reducing Burden in the Administration of Federal Financial Assistance in effort to provide government-wide direction to federal agencies on improving the management of federal financial assistance and to ensure the consistent management of such assistance. On April 22, 2024, OMB issued a final rule officially revising its regulations pertaining to federal financial assistance management in title 2 of the CFR and requiring agencies to implement the newly revised regulations as quickly as possible by taking appropriate steps to ensure the regulations apply to all federal financial awards issued on or after October 1, 2024.

The Help America Vote Act of 2002 limits the EAC's rulemaking authority to only to the extent permitted under Section 9(a) of the National Voter Registration Act. However, the EAC in this instance is “adopting” 2 CFR part 200—the EAC is not “making” rules. Furthermore, 2 CFR 200.106 states agencies awarding federal funds must implement the OMB guidance in 2 CFR in codified regulations.

The rule issued by the EAC concerns matters relating to “grants, benefits, or contracts,” 5 U.S.C. 553(a)(2), and is therefore exempt from the requirement of prior notice and comment.

Under 5 U.S.C. 553(d), agencies may waive the delayed effective date requirement if they find good cause and explain the basis for the waiver in the final rulemaking document or if the regulations grant or recognize an exemption or relieve a restriction.

OMB informed the public on April 4, 2024, that agencies would be required to adopt the Uniform Guidance and make it effective by October 1, 2024. The public has had significant time to prepare for the promulgation of these final regulations. As such, the EAC has determined there is good cause to waive the delayed effective date.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, as amended (referred to below as the Bioterrorism Response Act or the Act) provides for the regulation of certain biological agents and toxins that have the potential to pose a severe threat to human, animal, and plant health, or to animal and plant products. The Animal and Plant Health Inspection Service (APHIS) has the responsibility for implementing the provisions of the Bioterrorism Response Act within the U.S. Department of Agriculture (USDA). Veterinary Services (VS) select agents and toxins, listed in 9 CFR 121.3, are those that have been determined to have the potential to pose a severe threat to animal health or animal products. Plant Protection and Quarantine (PPQ) select agents and toxins, listed in 7 CFR 331.3, are those that have been determined to have the potential to pose a severe threat to plant health or plant products. Overlap select agents and toxins, listed in 9 CFR 121.4, are those that have been determined to pose a severe threat to public health and safety, to animal health, or to animal products. Overlap select agents are subject to regulation by both APHIS and the Centers for Disease Control and Prevention (CDC), which has the primary responsibility for implementing the provisions of the Act for the U.S. Department of Health and Human Services (HHS). Together, APHIS and CDC comprise the Federal Select Agent Program (FSAP).

Title II, Subtitle B of The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, as amended, (which is cited as the “Agricultural Bioterrorism Protection Act of 2002,” and referred to below as the Act), section 212(a)(1)(A) (7 U.S.C. 8401(a)(1)(A)), provides, in part, that the Secretary of Agriculture (the Secretary) “shall by regulation establish and maintain a list of each biological agent and each toxin that the Secretary determines has the potential to pose a severe threat to animal or plant health, or to animal or plant products.”

In determining whether to include an agent or toxin in the list, the Secretary shall consider the following criteria stated in the Act (7 U.S.C. 8401(a)(1)(B)):

• “[T]he effect of exposure to the agent or toxin on animal or plant health, and on the production and marketability of animal or plant products;”

• “[T]he pathogenicity of the agent or the toxicity of the toxin and the methods by which the agent or toxin is transferred to animals or plants;”

• “[T]he availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by the agent or toxin;”

• “[W]hether such inclusion would have a substantial negative impact on the research and development of solutions for the animal or plant disease caused by the agent or toxin; and whether the negative impact [on research and development] would substantially outweigh the risk posed by the agent or toxin to animal or plant health if it is not included on the list” (added by the 2018 Farm Bill); and

• “[A]ny other criteria that the Secretary considers appropriate to protect animal or plant health, or animal or plant products.”

Paragraph (a)(2) of section 212 of the Act (7 U.S.C. 8401(a)(2)) requires the Secretary to review and republish the list of select agents and toxins every 2 years and to otherwise revise the list as necessary. To fulfill this statutory mandate, APHIS convenes separate interagency working groups in order to review the lists of PPQ and VS select agents and toxins, as well as any overlap select agents and toxins, and develop recommendations regarding possible changes to the list using the five criteria for listing, stated above, found in the Act. APHIS and CDC coordinate on the biennial review for overlap select agents and toxins that have been determined to pose a severe threat to human and animal health or animal products.

On March 17, 2020, we published in the Federal Register (85 FR 15078-01, Docket No. APHIS-2019-0018) an advance notice of proposed rulemaking (ANPR)  1 and request for comments in which we solicited public comment on the possible delisting of one PPQ select agent, Peronosclerospora philippinensis (P. sacchari), one VS select agent, African horse sickness virus, and five overlap select agents, Bacillus anthracis (Pasteur strain), Brucella abortus, B. suis, and B. melitensis, and Venezuelan equine encephalitis virus. We discussed the comments received on the ANPR in the proposed rule that followed. On January 30, 2024, we published in the Federal Register (89 FR 5795-5819, Docket No. APHIS-2019-0018) a proposal  2 to amend and republish the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. We proposed to delist P. philippinensis ( sacchari), African horse sickness virus, B. abortus, B. suis, and B. melitensis.

In the proposed rule, we also proposed additional changes to the regulations beyond those discussed in the ANPR. Certain of these changes were, in our assessment, codifications of existing operational policy. These included provisions related to: Discovery of a select agent or toxin, disposal of select agent waste after conclusion of patient care, the exclusion of animals naturally infected with select agents from the requirements of the regulations, allowing individuals other than the responsible official ( e.g., principal investigators) to revise inactivation procedure documentation, removal procedures, and the content of annual internal inspections.

Other changes were intended as clarifications of existing provisions of the regulations. These included proposed definitions of loss, release, and theft, clarifying reporting requirements for “discovered” select agents or toxins, a clarification regarding what constitutes an acceptable “validated inactivation procedure,” clarifications related to the existing reporting requirements, clarifying that certificates must accompany transfers of a select agent or toxin, including intra-entity transfers, clarifying that the documentation in the IT system for the FSAP program serves as official records required by the regulations, clarifying the documentation that may be needed for the issuance of a certificate of registration, clarifying that a responsible official cannot be approved as the responsible official at more than one registered entity and cannot be the sole alternate responsible official at another registered entity, clarifying requirements related to restricted experiments, clarifying the notification requirements for changes to the application for registration, and clarifying the scope of pre-access suitability assessments.

Finally, certain proposed provisions would have been new, including provisions regarding effluent decontamination system, biosafety provisions for facility verification requirements for registered biosafety level 3 and animal biosafety level 3 laboratories, and a new requirement related to restricted experiments.

We solicited comments concerning our proposal for 60 days, ending April 1, 2024. We received 69 comments by that date. The comments were from private citizens, research institutions, organizations representing research institutions, organizations representing the domestic cattle, bison, and equine industries, representatives from State fish and wildlife departments, and representatives from State departments of agriculture.

While commenters largely supported our proposed amendments to the list of select agents and toxins, commenters raised legal, operational, and policy concerns about many of our proposed codifications, clarifications, and additions to the regulations.

We proposed to delist P. philippinensis, African horse sickness virus, B. abortus, B. suis, and B. melitensis as select agents, and the comments we received regarding these select agents are discussed below.

We received one comment specifically addressing P. philippinensis. The commenter supported delisting P. philippinensis, citing cultivation characteristics that would make propagation difficult and unlikely to produce a dangerous agent. We did not receive any comments stating an opposition to delisting. Accordingly, we are delisting P. philippinensis as proposed.

We received two comments specifically addressing AHS virus.

One commenter agreed with delisting, citing limited communicability and the existence of countermeasures. Another commenter opposed delisting, citing the widespread presence of the disease's vectors in the United States, the high mortality rate for animals associated with the disease, and the absence of available vaccines for AHS virus within the United States. The commenter did acknowledge that vaccines were available internationally but stated that there were no guidelines for their use within the United States, nor did they think APHIS would authorize their use in the event of an outbreak. The commenter further stated that, even if APHIS were to authorize their use in the event of a domestic outbreak of AHS virus, the specific serotype would need to be identified, and a monovalent vaccine procured from a foreign source, which could take months.

We agree that AHS virus causes a life-threatening, hemorrhagic, noncontagious, nonzoonotic, arthropod-borne viral disease of equines. However, the Act's aim is not solely to determine whether a pathogen causes deadly disease, but whether it is likely to be used as a bioterrorism agent, and if used, what the potential impacts would be. In that regard, in deciding whether an agent or toxin should be included on the select agent and toxin list, the Act requires us to take into consideration not only the pathogenicity of the agent, but also the methods by which it is disseminated, and the availability and effectiveness of prophylaxis as well as treatments, such as vaccines and pharmaceuticals.

AHS virus must use arthropod vectors in order to be transmitted. While the commenter is correct that arthropod vectors for the disease do exist within the United States, both the AHS virus and its vector must be present in an environment for transmission to equines to occur, making the virus difficult to effectively disseminate in equine populations. Therefore, we concluded that the AHS virus will unlikely be used as a bioterrorism agent. Additionally, while the commenter is correct that currently there are no vaccines available in the United States for AHS, and, accordingly, no guidelines yet established for use of AHS vaccines within the United States, vaccines are available internationally and in the event of foreign animal disease outbreak, USDA can implement emergency response plans. USDA's manual for response to an introduction of a foreign animal diseases, such as AHS, is found at https://www.aphis.usda.gov/sites/default/files/fadprep_manual_1.pdf.

The difficulty in disseminating and transmitting AHS virus and the availability of vaccines played a significant role in the Agricultural Interagency Select Agents and Toxins Technical Advisory Committee, or Ag-ISATTAC's, recommendation to delist AHS virus as a select agent.

Based on the foregoing considerations, we are delisting AHS virus as a select agent, as proposed.

We received 44 comments supporting delisting of all three species of Brucella ( B. abortus, B. suis, and B. melitensis ). These commenters supported delisting for one or more of the following reasons:

• State animal health officials, researchers, and industry stakeholder groups stated that these species are unlikely to be intentionally used as an agent of bioterrorism. They commented that Brucella has a limited to negligible rate as a bioterrorism weapon and the benefits ( e.g., research, testing, etc.) outweigh the risks. Also, they stated that these organisms are effectively contained within appropriate biosafety and biosecurity facilities, limiting access to unauthorized individuals.

• Private citizens and animal health groups stated that existing regulatory burden prevents ongoing research into vaccine development specifically in the areas of vaccine efficacy and vaccine delivery in wildlife. We agree regarding the burden to the research community, and that more robust studies can help limit the spread of disease.

• Private citizens commented that brucellosis in humans is rarely fatal and easily treatable in the early stages.

• Stakeholders and private citizens, also, said intervention strategies to reduce the disease in animal populations exist: There are already nationally recognized biosafety measures used by U.S. researchers in handling these agents. For instance, there are effective and well-established antibiotic treatment regimens for brucellosis due to infections with B. abortus, B. melitensis, or B. suis.

We received an additional 11 comments that only addressed B. abortus and supported delisting it. In addition to the above considerations, these commenters supported delisting B. abortus to facilitate research and development of more effective vaccines for wildlife reservoirs of the agent.

We received two comments opposing delisting of one or more of the Brucella spp. One commenter opposed delisting Brucella spp. pending vaccine development, citing an incident where the commenter claimed more than 300 veterinary medical professionals in a foreign country were exposed to B. abortus while vaccinating cattle, with multiple mortalities.

While human health considerations generally fall outside of APHIS' administration of the Act, and are instead under the purview of CDC, because the commenter raised concerns related to transmissibility due to human interaction with livestock, we wish to provide context for the incident cited by the commenter and respond to the stated concerns.

The above-cited incident did not occur in the United States. While misuse of vaccines, and improper vaccination protocols have, on rare occasion, resulted in transmission of the vaccine strain of B. abortus to humans domestically, antibiotics are widely available within the United States to treat incidents of brucellosis in humans, and mortality is rare. The Act also directs us to consider not only the availability of prophylaxis, such as vaccines, but also pharmacotherapies, such as antibiotics. For these reasons, we disagree with the commenter that B. abortus should not be delisted pending vaccine development. The commenter also did not contest our reasons in the proposed rule for delisting B. abortus: The agent is unlikely to be used as an agent of bioterrorism for a large-scale population introduction due to the high concentration of the agent necessary to produce disease as well as modern cattle production processes that limit animal-to-animal transmission routes; there is an efficacious vaccine; there is moderate immunity status within vulnerable populations; there is limited farm-to-farm transmission risk; and there are effective quarantine procedures. In this regard, we note that several of the commenters who supported delisting B. abortus provided scientific research or articles that buttressed these considerations.

Another commenter claimed, without evidence, that B. abortus was not a real disease, and being used as a pretext to kill bison.

The commenter is incorrect. B. abortus is a documented disease of cattle and bison.

Multiple commenters supportive of delisting Brucella spp. stated that B. abortus is a serious human health risk, and supported delisting insofar as it would, among other things, facilitate vaccine development in cattle and bison that could reduce rancher exposure to the disease.

As we noted above, human health considerations generally fall outside of APHIS' administration of the Act. However, we disagree with the commenters' characterization of the human health risk presented by brucellosis. While it can be fatal, the case fatality rate and person-to-person transmission for B. abortus continues to be very low. In addition, the human illnesses caused by B. abortus are readily recognized and can be treated with widely available antibiotics.

One commenter requested clarification that the diseases would still be reportable, even if delisted as select agents, and that the domestic brucellosis eradication program would still remain.

Brucellosis is a livestock disease that is reportable to State and Federal animal health authorities in the United States when an outbreak occurs. Our domestic brucellosis eradication program is administered by APHIS and State animal health authorities under a different statute, the Animal Health Protection Act (7 U.S.C. 8301-8317), and will remain in effect. 3

One commenter stated that it was the commenter's understanding that CDC biosafety level 3 (BSL 3) requirements will still be in effect for Brucella spp. even if all three agents are delisted.

Delisting of an agent neither reduces nor affects the recommended biosafety level for laboratory work. BSL 3 laboratory safety and containment is currently recommended for laboratory work with Brucella spp. The current BSL 3 laboratory safety and containment recommendations for Brucella spp. are outlined in the Biosafety in Microbiological and Biomedical Laboratories (BMBL), available at: https://www.cdc.gov/labs/bmbl/index.html.

Finally, several commenters stated that research facilities registered with FSAP and currently conducting ongoing research on Brucella spp. will need guidance regarding the impacts of delisting on their work. FSAP will provide such guidance.

Accordingly, we are delisting B. abortus, B. melitensis, and B. suis as select agents, as proposed.

Finally, we received a few comments on CDC's list of select agents and toxins. These comments are outside of the scope of this rulemaking, and APHIS has routed them to CDC for consideration.

In its January 30, 2024, proposed rule (89 FR 5823-1), CDC proposed designating Nipah virus, an overlap select agent, as a Tier 1 select agent because of its human transmissibility, high case fatality rate, high severity of illness, and severe long-term effects. However, due to an inadvertent oversight in our proposed rule, APHIS did not propose parallel changes. In its final rule published elsewhere in this issue of the Federal Register , CDC is designating Nipah virus as a Tier 1 select agent as proposed based on consideration of the comments received. As a result of CDC's decision, because Nipah virus is an overlap select agent, in this final rule, we are amending 9 CFR 121.3(b) to add an asterisk before “Nipah virus,” thus indicating its designation as a Tier 1 select agent. We are doing this to ensure harmonization between our regulations and CDC's regulations regarding this designation.

Therefore, for the reasons given, we are adopting the proposed revisions to the lists of select agents and toxin set forth in 7 CFR 331.3(b) and 9 CFR 121.3(b) and (b) that arose out of the biennial review of the list as final, with the change discussed immediately above. Executive Orders 12866 and 13563 and Regulatory Flexibility Act

This final rule has been determined to be significant for the purposes of Executive Order 12866 as amended by Executive Order 14094, “Modernizing Regulatory Review,” and, therefore, has been reviewed by the Office of Management and Budget.

We have prepared an economic analysis for this final rule. The economic analysis provides a cost-benefit analysis, as required by Executive Orders 12866 and 13563, which direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The economic analysis also examines the potential economic effects of this rulemaking on small entities, as required by the Regulatory Flexibility Act.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188), as amended (referred to below as the Bioterrorism Response Act), provides for the regulation of certain biological agents and toxins that have the potential to pose a severe threat to human, animal, or plant health, or to animal or plant products. APHIS, Emergency & Regulatory Compliance Services (ERCS), and the Division of Agricultural Select Agents and Toxins (DASAT) have the primary responsibility for implementing the provisions of the Bioterrorism Response Act with the USDA. Within APHIS, VS select agents and toxins, listed in 9 CFR 121.3, are those that have been determined to have the potential to pose a severe threat to animal health or animal products, and PPQ select agents and toxins, listed in 7 CFR 331.3, are those that have been determined to have the potential to pose a severe threat to plant health or plant products. Overlap select agents and toxins, listed in 9 CFR 121.4, are those that have been determined to pose a severe threat to public health and safety, to animal health, or to animal products. Overlap select agents and toxins are subject to regulation by both APHIS, ERCS, DASAT, and the CDC's Division of Regulatory Science and Compliance (DRSC), which has the primary responsibility for implementing the provisions of the Bioterrorism Response Act for the U.S. Department of Health and Human Services (HHS). Together, APHIS, ERCS, DASAT, and CDC's DRSC comprise the Federal Select Agent Program (FSAP).

Title II, Subtitle B of the Bioterrorism Response Act (which is cited as the “Agricultural Bioterrorism Protection Act of 2002,” as amended, and referred to below as the Act), section 212(a)(1) (7 U.S.C. 8401(a)(1)), provides, in part, that the Secretary of Agriculture (the Secretary) must establish and maintain, by regulation, a list of each biological agent and each toxin that the Secretary determines has the potential to pose a severe threat to animal or plant health, or to animal or plant products. Paragraph (a)(2) of section 212 of the Act (7 U.S.C. 8401(a)(2)) requires the Secretary to review and republish the list of select agents and toxins every two years and to otherwise revise the list as necessary. To fulfill this statutory mandate, APHIS convenes separate interagency working groups to review the list of PPQ and VS select agents and toxins, as well as any overlap select agents and toxins, and develop recommendations regarding possible changes to the list using the five criteria for listing found in the Act. APHIS and CDC coordinate on the biennial review for overlap select agents and toxins that have been determined to pose a severe threat to human and animal health or animal products.

APHIS is delisting three overlap select agents: Brucella abortus, Brucella suis, and Brucella melitensis. CDC has made parallel regulatory changes with respect to these Brucella spp. APHIS is also delisting one PPQ select agent, Peronosclerospora philippinensis ( Peronosclerospora sacchari ), and one VS select agent, African horse sickness (AHS) virus. These delisting changes will economically benefit producers, research and reference laboratories, and State and Federal oversight agencies, while also maintaining adequate program oversight of delisted select agents and toxins through HHS CDC and National Institutes of Health guidelines along with USDA-APHIS permits for movement.

Previous regulatory restrictions had effectively prohibited vaccine trials using natural transmission models, limited the opportunity for large animal studies, inhibited available surveillance, and prohibited studies that would evaluate vaccine or diagnostic product efficacy through comingling vaccinated and naturally infected animals. Delisting these five agents could decrease disease management costs for State and Federal governments as well as livestock producers. Additionally, delisting will remove restrictions that limited courier availability for these five agents, a factor that previously resulted in prohibitive shipment costs for many laboratories. Previous shipment costs had inhibited isolate sharing between reference and research laboratories, thus leading to decreased advancements from researchers and laboratories involved in diagnostic improvements and disease eradication efforts. Delisting the three Brucella agents ( B. abortus, B. suis, and B. melitensis ) as overlap select agents and one VS agent, AHS virus, along with one plant agent, Peronosclerospora philippinensis, from the list of select agents and toxins will economically benefit producers, research and reference laboratories, and State and Federal oversight agencies.

B. abortus presents little economic or animal health risk as a bioterrorism agent as it is unlikely to result in large-scale population introduction due to the high concentration of the agent necessary to produce disease as well as modern cattle production processes that limit animal-to-animal transmission routes. There is an efficacious vaccine, moderate immunity status within vulnerable populations, limited farm-to-farm transmission risk, and effective quarantine procedures. (Center for Food Security and Public Health, 2009; Moreno, E., 2014; Olsen, S.C., 2011.) B. melitensis primarily affects goats and sheep and is of lesser concern because the low farm-to-farm transmission risk due to modern production practices limits the chance of introduction on a scale large enough to impact domestic production. (The Center for Food Security and Public Health, 2009; Moreno, E., 2014; Olsen, S.C., 2011.) B. suis also presents a low to moderate animal health risk due to limited farm-to-farm transmission risk because of modern production practices, which reduce the risk of a large-scale introduction. (The Center for Food Security and Public Health, 2009; Stoffregen, W.C., 2006; World Organizsation for Animal Health (OIE), 2017; Zhu, L., et al., 2016.) For these reasons and due to the overwhelming public support, APHIS, in conjunction with CDC, is delisting these three Brucella species.

Peronosclerospora philippinensis ( Peronosclerospora sacchari ) is only able to survive and reproduce in the host plant and requires specific environmental conditions to become infectious, for which mitigations exist. The production characteristics for large volume production and subsequent dissemination require extensive specialization and reflect high degree of difficulty for dissemination of the agent. Thus, the economic impact of possible misuse of this agent was deemed a low impact. We are delisting the agent based upon affirmative responses to proposed delisting.

AHS virus causes a life-threatening, hemorrhagic, noncontagious, nonzoonotic, arthropod-borne viral disease of equines. However, the Act's aim is not solely to determine whether a pathogen causes deadly disease, but whether it is likely to be used as a bioterrorism agent, and if used, what the potential impacts would be. In that regard, in deciding whether an agent or toxin should be included on the select agent and toxin list, the Act requires us to take into consideration not only the pathogenicity of the agent, but also the methods by which it is disseminated, and the availability and effectiveness of prophylaxis as well as treatments, such as vaccines and pharmaceuticals. AHS is an arthropod-borne illness that must be vectored to be transmitted. Because both the disease and its vector must be present in an environment for transmission to equines to occur, we considered AHS unlikely to be used as an agent of bioterrorism. Vaccines are also available internationally and in the event of foreign animal disease outbreak, we can implement emergency response plans. Based on the foregoing considerations, we are delisting AHS virus as a select agent.

Currently, there are 236 entities registered with APHIS and CDC. Of these entities, 13 are private entities, 30 are Federal entities, 42 are commercial entities, 84 are academic entities, and 67 are State entities. Less than 32 percent of all firms operating within these North American Industry Classification (NAICS) categories are considered to be small entities.

This document provides a cost-benefit analysis, as required by Executive Orders 12866, 13563, and 14094 which direct Federal agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This document also examines the potential economic effects of this rulemaking on small entities, as required by the Regulatory Flexibility Act.

Pursuant to the Agricultural Bioterrorism Protection Act of 2002, as amended (7 U.S.C. 8401(a)(2)) (Act), APHIS has completed its required biennial review of the current list of select agents and toxins in 7 CFR 331.3 (PPQ select agents) and 9 CFR 121.3 (VS select agents) and 121.4 (overlap select agents overseen jointly with CDC). This final rule implements the recommendations of the interagency working groups with respect to the list of select agents and toxins. APHIS, in conjunction with CDC, is removing the following overlap select agents from the list of select agents and toxins: Brucella abortus, Brucella suis, and Brucella melitensis. Public response showed overwhelming support for delisting all three Brucella species. Therefore, we consider it appropriate to delist these three Brucella spp.

We are also delisting Peronosclerospora philippinensis ( Peronosclerospora sacchari ). We received only supportive comments for this proposed delisting.

Finally, we are delisting AHS virus. While we received a comment opposed to this delisting, it did not call into question our considerations in proposing delisting.

As previously discussed, there are 236 entities registered with APHIS and CDC. Of these entities,13 are private entities, 30 are Federal entities, 42 are commercial entities, 84 are academic entities, and 67 are State entities. Of these, less than 32 percent of all entities within these NAICS categories are considered to be small entities. The delisting of B. abortus, B. suis, and B. melitensis is anticipated to economically benefit producers, research and reference laboratories, and State and Federal oversight agencies, while also maintaining adequate program oversight of delisted select agents and toxins through HHS CDC and National Institutes of Health guidelines along with USDA-APHIS permits for movement. Below we provide a cost-benefit analysis, as required by Executive Orders 12866, 13563, and 14094 to examine the potential economic effects of delisting B. abortus, B. suis, B. melitensis, Peronosclerospora philippinensis ( Peronosclerospora sacchari ), and AHS virus on small entities.

There are currently costs associated with registration of the select agents that we are delisting. There are no direct costs for regulated entities associated with the delisting of Brucella species, only benefits to facilities to participate in Brucella research. If Brucella species are delisted, APHIS regulations requiring permits for their movement pursuant to 9 CFR part 122 will be operative, however; new permits cost $150 and permitting information is found here: https://www.aphis.usda.gov/animal-product-import/organisms-vectors. Many entities have been requesting the delisting of the Brucella spp. for years. State Veterinarians have expressed concern regarding the limitation on brucellosis research because of the designation of Brucella as a select agent. 4

Livestock producer organizations and the United States Animal Health Association have voiced their support and the need for the development of a B. suis vaccine, as well as improved diagnostics for Brucella spp. 5 Similarly, Peronosclerospora philippinensis ( Peronosclerospora sacchari ) has received public support for delisting as the agent is only able to survive and reproduce in the host plant, and AHS, while a life-threatening viral disease of equines, is unlikely to be used as a bioterrorism agent. Previous regulatory restrictions had effectively prohibited vaccine trials using natural transmission models, limited the opportunity for large animal studies, inhibited available surveillance, and prohibited studies that would evaluate vaccine or diagnostic product efficacy through comingling vaccinated and naturally infected animals. These limitations increase disease management costs for State and Federal governments as well as livestock producers.

One previous example of the public requesting delisting of a select agent for research purposes was Valley Fever or Coccidiodes spp. Until October 2012, Valley Fever or Coccidiodes spp. had been listed as a select agent by both APHIS and CDC. Since delisting, additional research has taken place, resulting in enhanced outreach to inform potential infected citizens. Doctors and medical personnel also are more familiar with it and understand that climate change is contributing to this disease in California. Like Valley Fever, the high cost to work with Brucella spp. has prevented appropriate research and field studies to take place, thus hampering new information and research to limit or stop the spread of the disease or at least inform the public of its method of infection. Very few laboratories currently have the resources or ability to do Brucella spp. research due to the facility needs required by its current listing as a select agent under the regulations.

Due to the stringent transfer requirements in 9 CFR 121.16 for select agents, currently, there is limited courier availability for Brucella spp., Peronosclerospora philippinensis ( Peronosclerospora sacchari ), and AHS virus shipments. The lack of available couriers has resulted in prohibitive shipment costs for many laboratories. The increased shipment costs have inhibited isolate sharing between reference and research laboratories, thus leading to decreased advancements from researchers and laboratories involved in diagnostic improvements and disease eradication efforts. Removing the three Brucella species ( B. abortus, B. suis, and B. melitensis ) as overlap select agents and one VS agent, AHS virus, along with one plant agent, Peronosclerospora philippinensis, from the list of select agents and toxins will thus economically benefit producers, research and reference laboratories, and, for Brucella abortus delisting, State and Federal oversight agencies.

As described, any impacts of delisting these agents from the list of select agents and toxins are expected to be beneficial for the affected industries.

Entities that possess, use, or transfer B. abortus, B. suis, and B. melitensis along with Peronosclerospora philippinensis ( Peronosclerospora sacchari ) and AHS virus would either benefit or be unaffected by this final rule. Potentially affected entities include laboratories, other research institutions, and related entities in possession of the Brucella spp. Affected entities (other than Federal and State governmental entities) are likely found within the following NAICS categories:

• 541714, Research and Development in Biotechnology;

• 541715, Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology);

• 325412, Pharmaceutical Preparation Manufacturing;

• 325413, In-Vitro Diagnostic Substance Manufacturing;

• 325414, Biological Product (except Diagnostic) Manufacturing;

• 541940, Veterinary Services;

• 611310, Colleges, Universities and Professional Schools;

• 621511, Medical Laboratories;

• 622110, General Medical and Surgical Hospitals.

The Small Business Administration (SBA) has established small-entity size standards based on the NAICS categories. An entity classified within NAICS 541714 and NAICS 541715 is considered small with 1,000 or fewer employees, and one within NAICS, 325413, and 325414 is considered small with 1,250 or fewer employees and one with NAICS 325124 is considered small with 1,300 or fewer employees. An entity within NAICS 541940 is considered small with annual receipts of $10 million or less, and an entity within NAICS 611310 is considered small with annual receipts of not more than $34.5 million. Entities classified within NAICS 621511 are considered to be small if they have annual receipts of not more than $41.5 million. An entity classified within NAICS 622110 is considered to be small with annual receipts of not more than $47 million.

As described above, entities that possess, use, or transfer the delisted agents are not expected to be significantly affected by this final rule and will benefit from the enhanced ability to further perform research on the relevant agent.

Currently, there are 236 entities registered with APHIS and CDC. Of these entities, 13 are private entities, 30 are Federal entities, 42 are commercial entities, 84 are academic entities, and 67 are State entities. Approximately 32 percent of all entities within these NAICS categories of laboratories are considered to be small entities and 68 percent are considered large entities.

Of these 236 registered entities, potentially affected entities include laboratories, other research institutions, and related entities in possession of select agents. Potentially affected entities (other than Federal and State governmental entities) are likely found within the following NAICS categories:

• 541714, Research and Development in Biotechnology;

• 541715, Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology);

• 325412, Pharmaceutical Preparation Manufacturing;

• 325413, In-Vitro Diagnostic Substance Manufacturing;

• 325414, Biological Product (except Diagnostic) Manufacturing;

• 541940, Veterinary Services;

• 611310, Colleges, Universities and Professional Schools;

• 621511, Medical Laboratories; or

• 622110, General Medical and Surgical Hospitals.

The SBA has established small-entity size standards based on the NAICS categories. An entity classified within NAICS 541714 and NAICS 541715 is considered small with 1,000 or less employees, and an entity classified within NAICS 325412 is considered small with 1,300 or less employees, 325413, and 325414 is considered small with 1,250 or less employees. An entity in NAICS 541940 is considered small with annual receipts of $10 million or less, and an entity in NAICS 611310 is considered small with annual receipts of not more than $34.5 million. Entities classified within NAICS 621511 are considered to be small if they have annual receipts of not more than $41.5 million. An entity classified within NAICS 622110 is considered to be small with annual receipts of not more than $47 million.

While the breakdown of the size of the entities, as reported by the 2017 Economic Census (updated subset of 2021 County Business Patterns released on July 3, 2024), does not precisely fit the SBA guidelines, the data indicates that the majority (68 percent) of the entities in industries potentially affected by this final rule, other than post-secondary institutions, can be considered large entities. In other words, over 68 percent of all entities included in the above mentioned NAICS codes are large entities meaning only approximately 32 percent of these entities are small entities  6 (see table 1 below). According to the 2017 Economic Census and 2021 subset, the most recent census data available for all entities, 98 percent of entities in NAICS 541714 and 96 percent 541715, 93 percent of entities in NAICS 325412, 86 percent of entities in NAICS 325413, 86 percent of entities in NAICS 325414, 0 percent of entities in NAICS 541940, 13 percent of entities in NAICS 621511, 7 percent of entities in NAICS 611310, and 3 percent of entities in NAICS 622110 can be classified as small entities. 7

Table of Contents I. Authority and Background A. Authority B. Background II. Discussion III. Summary of Public Comments IV. Section 1008.12 Analysis V. Procedural Issues and Regulatory Review A. Review Under Executive Orders 12866, 13563, and 14094 B. Review Under the Regulatory Flexibility Act C. Review Under the Paperwork Reduction Act of 1995 D. Review Under the National Environmental Policy Act of 1969 E. Review Under Executive Order 12988 F. Review Under Executive Order 13132 G. Review Under Executive Order 13175 H. Review Under the Unfunded Mandates Reform Act of 1995 I. Review Under Executive Order 12360 J. Review Under Executive Order 13211 K. Review Under the Treasury and General Government Appropriations Act, 1999 L. Review Under the Treasury and General Government Appropriations Act, 2001 M. Congressional Notification VI. Approval by the Office of the Secretary of Energy I. Authority and Background A. Authority

DOE has broad authority to manage the agency's collection, use, processing, maintenance, storage, and disclosure of Personally Identifiable Information (PII) pursuant to the following authorities: 42 United States Code (U.S.C.) 7101 et seq., 50 U.S.C. 2401 et seq., 5 U.S.C. 1104, 5 U.S.C. 552, 5 U.S.C. 552a, 42 U.S.C. 7254, 5 U.S.C. 301, and 42 U.S.C. 405 note.

The Privacy Act of 1974 (the Act) (5 U.S.C. 552a) embodies fair information practice principles in a statutory framework governing the means by which the U.S. Government collects, maintains, uses, and disseminates personally identifiable information. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents.

The Privacy Act includes two sets of provisions that allow agencies to claim exemptions from certain requirements in the statute. These provisions allow agencies in certain circumstances to promulgate rules to exempt a system of records from certain provisions of the Privacy Act. For this system of records, pursuant to 5 U.S.C. 552a(k)(1), the Department exempts this system of records from subsections (c)(3); (d); (e)(1), (e)(4)(G), (4)(H), and (4)(I); and (f) of the Privacy Act. This exemption is needed to protect information relating to DOE activities from disclosure to subjects or others related to these activities. Specifically, the exemption is required to safeguard classified information. Pursuant to the Privacy Act and Office of Management and Budget (OMB) Circular A-108, Federal Agency Responsibilities for Review, Reporting, and Publication under the Privacy Act, DOE is issuing this Rule to make clear to the public the reasons why this particular exemption is being applied.

The Department is exempting portions of a newly established system of records—DOE-85, Research, Technology, and Economic Security Due Diligence Review Records—from subsections (c)(3); (d); (e)(1), (e)(4)(G), (4)(H), and (4)(I); and (f) of the Privacy Act of 1974. To claim this exemption, DOE is amending 10 CFR 1008.12 by adding a new paragraph, (b)(1)(ii)(N). The Department exempts portions of this system of records from these subsections of the Privacy Act because of requirements related to classified information.

The purpose of this system is to enhance DOE's capabilities to aggregate, link, analyze, and maintain information used by the Department to assess research, technology, and economic security (RTES) risk. RTES risks may include risk of foreign government interference and exploitation, intellectual property (IP) loss, national security risk, conflicts of interest, and conflicts of commitment, and other parameters defined in DOE/National Nuclear Security Administration (NNSA) policy. The RTES analysis builds on pre-existing information provided by individuals and organizations that interact with DOE/NNSA, paired with public records, and in some cases, classified information. Consistent with National Security Presidential Memorandum-33  1 (NSPM-33), applicable law, and existing DOE/NNSA policies, the system records may be shared as appropriate with other Federal funding agencies and internally within DOE/NNSA to help ensure a coordinated and consistent approach to risk assessment.

For this system of records, the system is exempted from subsections (c)(3); (d); (e)(1), (e)(4)(G), (4)(H), and (4)(I); and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(1). This exemption is needed to protect information relating to DOE activities from disclosure to subjects or others related to these activities. Specifically, the exemption is required to safeguard classified information.

This exemption is a standard national security exemption exercised by many Federal intelligence agencies. Although the RTES Office is not an intelligence agency, the system of records utilized by the RTES Office may include classified information obtained from Federal intelligence sources.

Exemptions for DOE-85 Research, Technology, and Economic Security Due Diligence Review Records from this particular subsection of the Privacy Act are justified on a case-by-case basis to be determined at the time a request is made for the following reasons:

From 5 U.S.C. 552a subsection (k)(1) because providing individuals access to classified information could cause serious damage to the national defense or foreign policy.

On September 10, 2024, DOE published a notice of proposed rulemaking (NOPR) (89 FR 73312). This NOPR claimed the 5 U.S.C. 552a(k)(1) exemption listed in the preceding paragraph. As a result of this NOPR, DOE received one comment, discussed in section III of this document.

As mentioned in previously, DOE received one comment in response to the NOPR (DOE-HQ-2023-0058-0005). The commenter requested a clearer explanation of how conflicts of interest and commitment necessitate exemptions from the Privacy Act and for DOE to consider narrowing the scope of Privacy Act exemptions, particularly the exemption from 5 U.S.C. 552a(e)(1). The commenter points out that the exemption from 5 U.S.C. 522a(e)(1) is too broad and could result in the accumulation of unnecessary information, creating unintended consequences such as the misuse of personal information. Finally, the commenter also stated that Freedom of Information Act (FOIA) liability may also be triggered from people trying to get information they believe is held under exemption.

As to the issue regarding conflicts of interest and commitment, DOE would like to clarify that the justification for exempting the system is based on the extent to which the system contains classified information. This is consistent with 10 CFR 1008.12(b)(1), where 5 U.S.C. 552a(k)(1) applies to the system only “to the extent [that the system] contain[s] classified information, in order to prevent serious damage to the national defense or foreign policy that could arise from providing individuals access to classified information.” Determining if something is exempt will be done on a case-by-case basis, and if there is no classified information or national security information, then included information under 5 U.S.C. 552a(k)(1) would not be exempt.

As to the commenters concerns that the exemption from 5 U.S.C. 522a(e)(1) is too broad and could result in collection of irrelevant information, risking misuse of personal information, as well as concerns that the regulation could lead to legal challenges to withholding such information under FOIA, DOE respectfully disagrees. DOE makes clear in the NOPR and restates here, information within the system that meets the criteria of 5 U.S.C. 552a(k)(1) is exempted from disclosure from 5 U.S.C. 552a(e)(1) and the other identified provisions. Information that fails to meet such criteria is not exempted from the provision. Therefore, the exemption from 5 U.S.C. 552a(e)(1) is sufficiently tailored for consistency with 10 CFR 1008.12(b)(1), and determinations will be made on a case-by-case basis.

This final rule amends 10 CFR 1008.12(b)(1)(ii), by adding paragraph (b)(1)(ii)(N), referencing line item “(N) Research, Technology, and Economic Security Due Diligence Review Records (DOE-85)” to paragraph (b)(1)(ii). This addition will demonstrate that SORN DOE-85 is included among the other SORNs taking a 5 U.S.C. 552a (k)(1) exemption under the Privacy Act of 1974. This exemption allows DOE to “prevent serious damage to the national defense or foreign policy that could arise from providing individuals access to classified information.”

Executive Order (“E.O.”) 12866, “Regulatory Planning and Review,” 58 FR 51735 (Oct. 4, 1993), as supplemented and reaffirmed by E.O. 13563, “Improving Regulation and Regulatory Review,” 76 FR 3821 (Jan. 21, 2011) and amended by E.O. 14094, “Modernizing Regulatory Review,” 88 FR 21879 (April 11, 2023), requires agencies, to the extent permitted by law, to (1) propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify); (2) tailor regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations; (3) select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) to the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt; and (5) identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees or marketable permits, or providing information upon which choices can be made by the public. DOE emphasizes as well that E.O. 13563 requires agencies to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible. In its guidance, the Office of Information and Regulatory Affairs (OIRA) has emphasized that such techniques may include identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes. For the reasons stated in this preamble, this final rule is consistent with these principles.

Section 6(a) of E.O. 12866 requires agencies to submit “significant regulatory actions” to OIRA for review. OIRA has determined that this final rule is not a “significant regulatory action” within the scope of E.O. 12866. Accordingly, this action is not subject to review under E.O. 12866 by OIRA of the Office of Management and Budget (OMB).

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq. ) requires that an agency prepare an initial regulatory flexibility analysis for any regulation for which a final rule is required, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities (5 U.S.C. 605(b)). As required by Executive Order 13272, Proper Consideration of Small Entities in Agency Rulemaking, 67 FR 53461 (Aug. 16, 2002), DOE published procedures and policies on February 19, 2003, to ensure that the potential impacts of its rules on small entities are properly considered during the rulemaking process. 68 FR 7990. DOE has made its procedures and policies available on the Office of the General Counsel's website ( www.energy.gov/gc/office-general-counsel ).

DOE reviewed this final rule under the provisions of the Regulatory Flexibility Act and the procedures and policies published on February 19, 2003. DOE certifies that the final rule will not have significant economic impact on a substantial number of small entities. The factual basis for this certification is set forth below.

This final rule will update DOE's policies and procedures concerning the disclosure of records held within a system of records pursuant to the Privacy Act of 1974. This final rule will apply only to activities conducted by DOE's Federal employees and contractors, who would be responsible for implementing the rule requirements. DOE does not expect there to be any potential economic impact of this final rule on small businesses. Small businesses, therefore, should not be adversely impacted by the requirements in this final rule. For these reasons, DOE certifies that this final rule will not have a significant economic impact on a substantial number of small entities, and therefore, no regulatory flexibility analysis has been prepared.

This final rule does not impose a collection of information requirement subject to review and approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

Pursuant to the National Environmental Policy Act of 1969 (NEPA), DOE has analyzed this action in accordance with NEPA and DOE's NEPA implementing regulations (10 CFR part 1021). DOE's regulations include a categorical exclusion (CX) for rulemakings interpreting or amending an existing rule or regulation that does not change the environmental effect of the rule or regulation being amended. 10 CFR part 1021, subpart D, appendix A, paragraph A5. DOE has determined that this final rule is covered under the CX found in DOE's NEPA regulations at paragraph A5 of appendix A to subpart D, 10 CFR part 1021, because it is an amendment to an existing regulation that does not change the environmental effect of the amended regulation and, therefore, meets the requirements for the application of this CX. See 10 CFR 1021.410. Therefore, DOE has determined that this final rule is not a major Federal action significantly affecting the quality of the human environment within the meaning of NEPA and does not require an Environmental Assessment or an Environmental Impact Statement.

With respect to the review of existing regulations and the promulgation of new regulations, Section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (February 7, 1996), imposes on Federal agencies the general duty to adhere to the following requirements: (1) eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; (3) provide a clear legal standard for affected conduct rather than a general standard; and (4) promote simplification and burden reduction. Section 3(b) of Executive Order 12988 specifically requires that executive agencies make every reasonable effort to ensure the regulation: (1) clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for the affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; (6) specifies whether administrative proceedings are to be required before parties may file suit in court and, if so, describes those proceedings and requires the exhaustion of administrative remedies; and (7) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of the standards. DOE has completed the required review and determined that, to the extent permitted by law, this final rule meets the relevant standards of Executive Order 12988.

Executive Order 13132, “Federalism,” 64 FR 43255 (August 10, 1999), imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. Agencies are required to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and carefully assess the necessity for such actions. The Executive order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. DOE has examined this final rule and has tentatively determined that it would not preempt State law and would not have 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. No further action is required by Executive Order 13132.

Under Executive Order 13175 (65 FR 67249, November 6, 2000) on “Consultation and Coordination with Indian Tribal Governments,” DOE may not issue a discretionary rule that has “Tribal” implications and imposes substantial direct compliance costs on Indian Tribal governments. DOE has determined that this final rule will not have such effects and concluded that Executive Order 13175 does not apply to this final rule.

Title II of the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4) requires each Federal agency to assess the effects of a Federal regulatory action on State, local, and Tribal governments, and the private sector. (Pub. L. 104-4, sec. 201 et seq. (codified at 2 U.S.C. 1531 et seq. )). For a regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a “significant Federal intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect them. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. (62 FR 12820) (This policy is also available at: www.energy.gov/gc/guidance-opinions under “Guidance & Opinions” (Rulemaking).) DOE examined this final rule according to UMRA and its statement of policy and has determined that this final rule contains neither an intergovernmental mandate, nor a mandate that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year. Accordingly, no further assessment or analysis is required under UMRA.

DOE has determined, under Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights” 53 FR 8859 (March 18, 1988), that this regulation would not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to the OIRA, which is part of OMB, a Statement of Energy Effects for any significant energy action. A “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to promulgation of a final rule, and that: (1)(i) is a significant regulatory action under Executive Order 12866, or any successor order; and (ii) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (2) is designated by the Administrator of OIRA as a significant energy action. For any significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use. This regulatory action is not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects.

Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any final rule that may affect family well-being. This final rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516) provides for Federal agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (February 22, 2002), and DOE's guidelines were published at 67 FR 62446 (October 7, 2002). Pursuant to OMB Memorandum M-19-15, Improving Implementation of the Information Quality Act (April 24, 2019), DOE published updated guidelines which are available at: www.energy.gov/sites/prod/files/2019/12/f70/DOE%20Final%20Updated%20IQA%20Guidelines%20Dec%202019.pdf.

DOE has reviewed this final rule and will ensure that information produced under this regulation remains consistent with the applicable OMB and DOE guidelines.

As required by 5 U.S.C. 801, DOE will report to Congress on the promulgation of this rule prior to its effective date. The report will state that the rule does not, meet the criteria set forth in 5 U.S.C. 804(2).

The Secretary of Energy has approved publication of this Final rule.

This document of the Department of Energy was signed on December 11, 2024, by Ann Dunkin, Senior Agency Official for Privacy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

For the reasons set forth in the preamble, the Department of Energy amends part 1008 of chapter X of title 10 of the Code of Federal Regulations as set forth below:

Table of Contents I. Authority and Background A. Authority B. Background II. Discussion III. Summary of Public Comments IV. Section 1008.12 Analysis V. Procedural Issues and Regulatory Review A. Review Under Executive Orders 12866, 13563, and 14094 B. Review Under the Regulatory Flexibility Act C. Review Under the Paperwork Reduction Act of 1995 D. Review Under the National Environmental Policy Act of 1969 E. Review Under Executive Order 12988 F. Review Under Executive Order 13132 G. Review Under Executive Order 13175 H. Review Under the Unfunded Mandates Reform Act of 1995 I. Review Under Executive Order 12360 J. Review Under Executive Order 13211 K. Review Under the Treasury and General Government Appropriations Act, 1999 L. Review Under the Treasury and General Government Appropriations Act, 2001 M. Congressional Review VI. Approval by the Office of the Secretary of Energy I. Authority and Background A. Authority

DOE has broad authority to manage the agency's collection, use, processing, maintenance, storage, and disclosure of Personally Identifiable Information (PII) pursuant to the following authorities: 42 United States Code (U.S.C.) 7101 et seq., 50 U.S.C. 2401 et seq., 5 U.S.C. 1104, 5 U.S.C. 552, 5 U.S.C. 552a, 42 U.S.C. 7254, 5 U.S.C. 301, and 42 U.S.C. 405 note.

The Privacy Act of 1974 (the Act) (5 U.S.C. 552a) embodies fair information practice principles in a statutory framework governing the means by which the U.S. Government collects, maintains, uses, and disseminates personally identifiable information. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents.

The Privacy Act includes two sets of provisions that allow agencies to claim exemptions from certain requirements in the statute. These provisions allow agencies in certain circumstances to promulgate rules to exempt a system of records from certain provisions of the Privacy Act. For this system of records, pursuant to 5 U.S.C. 552a(k)(2), the Department exempts this system of records from subsections (c)(3); (d); and (e)(1) of the Privacy Act. This exemption is needed to protect from disclosure investigatory material compiled for law enforcement purposes. Pursuant to the Privacy Act and Office of Management and Budget (OMB) Circular A-108, Federal Agency Responsibilities for Review, Reporting, and Publication under the Privacy Act, DOE is issuing this final rule to make clear to the public the reasons why this particular exemption is being applied.

DOE is claiming an exemption from certain requirements of the Privacy Act for a new system of records: DOE-42 Nondiscrimination in Federally Assisted Programs Files.

The Department is exempting portions of a newly established system of records—DOE-42 Nondiscrimination in Federally Assisted Programs Files—from subsections (c)(3); (d); and (e)(1) of the Privacy Act of 1974. To claim this exemption, DOE is amending 10 CFR 1008.12 by adding a new paragraph, (b)(2)(ii)(R). The Department exempts portions of this system of records from these subsections of the Privacy Act because of requirements related to the compilation of investigatory material for law enforcement purposes.

DOE-42 Nondiscrimination in Federally Assisted Programs Files will provide a central electronic repository to: (i) maintain all records used by OCR-EEO personnel in making Federal civil rights compliance determinations with accuracy, relevance, timeliness, and completeness to assure fairness to the individual(s) in the determination; (ii) create appropriate administrative, technical, and physical safeguards that ensure the security and confidentiality of records and protect against any anticipated threats to their security or integrity and; (iii) create rules of conduct for authorized OCR-EEO personnel involved in the operation, maintenance, and routine uses for this system records.

For this system of records, DOE is claiming the Privacy exemption from requirements in subsections (c)(3); (d); and (e)(1) of the Privacy Act. In addition, the system has been exempted from the Privacy Act, pursuant to 5 U.S.C. 552a(k)(2). These exemptions are needed to protect information relating to DOE activities from disclosure to subjects or others related to these activities. Specifically, these exemptions from the Privacy Act are necessary in order to preclude subjects of these activities from frustrating these processes; to avoid disclosure of activity techniques; to protect the identities and physical safety of confidential informants and law enforcement personnel; to ensure DOE's ability to obtain information from third parties and other sources; and to protect the privacy of third parties. Disclosure of information to the subject of the inquiry could also permit the subject to avoid detection or apprehension.

Exemption from these Privacy Act requirements is standard for law enforcement and national security matters and are often exercised by many Federal law enforcement and intelligence agencies. In appropriate circumstances, where compliance would not appear to interfere with or adversely affect the law enforcement purposes of this system and overall law enforcement process, the applicable exemption of these requirements may be waived on a case-by-case basis.

Exemption from these particular Privacy Act requirements for DOE-42 Nondiscrimination in Federally Assisted Programs Files is justified, on a case-by-case basis to be determined at the time a request is made for the following reasons:

In particular, exemption from the Privacy Act's requirement in subsections (c)(3) (Accounting for Disclosures) is necessary because release of the accounting of disclosures could alert the subject of an investigation of an actual or potential criminal, civil, or regulatory violation to the existence of that investigation and reveal investigative interest on the part of DOE as well as the recipient agency. Disclosure of the accounting would, therefore, present a serious impediment to law enforcement efforts or efforts to preserve national security. Disclosure of the accounting would also permit the individual who is the subject of a record to impede the investigation, to tamper with witnesses or evidence, and to avoid detection or apprehension, which would undermine the entire investigative process.

Exemption from the Privacy Act's requirement in subsection (d) (Access to Records) is necessary because access to the records contained in this system of records could inform the subject of an investigation of an actual or potential criminal, civil, or regulatory violation to the existence of that investigation and reveal investigative interest on the part of DOE or another agency. Access to the records could permit the individual who is the subject of a record to impede the investigation, to tamper with witnesses or evidence, and to avoid detection or apprehension. Amendment of the records could interfere with ongoing investigations and law enforcement activities and would impose an unreasonable administrative burden by requiring investigations to be continually reinvestigated. In addition, permitting access and amendment to such information could disclose security-sensitive information that could be detrimental to nuclear or energy sector security.

Exemption from the Privacy Act's requirements in subsection (e)(1) (Relevancy and Necessity of Information) is necessary because in the course of investigations into potential violations of Federal law, the accuracy of information obtained or introduced occasionally may be unclear, or the information may not be strictly relevant or necessary to a specific investigation. In the interests of effective law enforcement, it is appropriate to retain all information that may aid in establishing patterns of unlawful activity.

On September 20, 2024, DOE published a notice of proposed rulemaking (NOPR) (89 FR 77040), and received one comment, discussed in detail below.

DOE received one public comment in response to its NOPR, and while the commenter was generally supportive of the rule, it raised the following concerns:

1. Concerns about exemption from subsection (c)(3): According to the commenter, the exemption from 5 U.S.C. 552a(c)(3) could lead to unauthorized disclosure or misuse of sensitive data, and result in abuse or information leaks. In lieu of this exemption, the commenter recommended the creation of partial exemptions or delayed disclosures.

DOE respectfully disagrees with the commenter regarding the exemption from 5 U.S.C. 552a(c)(3). The record itself is protected from unauthorized disclosure and misuse pursuant to subsection (e)(9) of the Privacy Act, which requires the agency to establish appropriate administrative, technical, and physical safeguards to ensure the security and confidentiality of records. Additionally, the Privacy Act governs records about individuals, not about entities that are subject to the Federal civil rights laws that OCR-EEO enforces. Where such information does constitute a record about an individual, this system of records allows the exemption from 5 U.S.C. 552a(c)(3) to be waived on a case-by-case basis in appropriate circumstances where accounting for disclosures would not interfere with or otherwise adversely affect the law enforcement purposes of this system of records or the overall law enforcement process. Finally, this exemption protects against misuses of sensitive data by preventing an accounting for disclosures from being used to alter or destroy evidence, improperly influence or intimidate witnesses, or further other evasive actions that could impede or compromise an investigation. DOE does not agree with the commenter's recommendation to create partial exemptions or delayed disclosures, as this exemption prevents a record subject from using an accounting to retaliate against investigation witnesses or invade the privacy of victims or other persons who engaged in protected activity, including confidential sources who otherwise would be unwilling to come forward or participate in an OCR-EEO investigation.

2. Concerns about the exemption from subsection (d): The commenter also asserted that the exemption from 5 U.S.C. 552a(d) raises serious fairness and due process concerns. In lieu of this exemption, the commenter recommended a tiered approach allowing individuals to request access to their records under certain conditions, such as when the information no longer poses a threat to law enforcement, or portions of the record are non-sensitive, or based on the record's relevance to the investigation.

DOE respectfully disagrees with the commenter, and believes this exemption accords with the fairness and due process protections of subsection (k)(2) of the Privacy Act, which expressly provides that any individual who would be denied any right, privilege, or benefit that such person would otherwise be entitled by Federal law, or to which such individual would otherwise be eligible as a result of the maintenance of material within a system of records shall be provided such material, except to the extent that the disclosure of such material would reveal the identity of a source who furnished information to the Government under an express or implied promise that the identity of the source would be held in confidence. Additionally, subsection (e)(5) of the Privacy Act requires OCR-EEO to maintain all records used in making any determination about any individual with such accuracy, relevance, timeliness, and completeness as is reasonably necessary to assure fairness to the individual in the determination.

3. Concerns about the exemption from (e)(1): The commenter additionally asserted that the exemption from 5 U.S.C. 552a (e)(1) raises concerns that DOE may retain information that is outdated, irrelevant, or unnecessarily harmful to individuals, which the commentor believes may lead to individuals being unfairly scrutinized or targeted based on information that is no longer accurate or relevant to the investigation. In relation to this exemption, the commenter recommended that DOE implement a regular review process based on a well-defined and publicly justifiable review standard, and also implement a central electronic repository to keep this system of records.

For the following reasons, DOE respectfully disagrees with the commenter regarding the exemption from 5 U.S.C. 552a(e)(1). First, it is often impossible to determine the relevance and necessity of information in the early stages of collection, investigation, or adjudication. Second, the DOE regulations implementing Federal civil rights laws define a federally assisted program or activity to mean all of the operations of any entity, any part of which is a recipient of Federal financial assistance from DOE. Third, information obtained during an OCR-EEO investigation may be relevant and necessary to the civil or criminal law enforcement activities of other Federal agencies, or concern a matter before Congress or a court of competent jurisdiction. Fourth, in furtherance of the administrative, technical, and physical safeguards delineated in the NOPR, the security and privacy controls applicable to this system of records are reviewed on an ongoing basis and updated in accordance with well-defined Federal government standards and DOE directives.

In response to the commenter's conclusion that DOE should provide a more complete description of this system of records, DOE brings the commenter's attention to the ample description provided by the NOPR regarding the administrative, technical, and physical safeguards applicable to this system of records.

This final rule adds line-item paragraph (b)(2)(ii)(Q), referencing “Nondiscrimination in Federally Assisted Program Files (DOE-42)”. This addition demonstrates that SORN DOE-42 is included among the other SORNs taking a subsection (k)(2) exemption under the Privacy Act of 1974. Per current regulations located at 10 CFR 1008.12(b)(2)(ii), this exemption allows DOE to “prevent subjects of investigation from frustrating the investigatory process through access to records about themselves or as a result of learning the identities of confidential informants; to prevent disclosure of investigative techniques; to maintain the ability to obtain necessary information; and thereby to insure the proper functioning and integrity of law enforcement activities.”

Executive Order (“E.O.”) 12866, “Regulatory Planning and Review,” 58 FR 51735 (Oct. 4, 1993), as supplemented and reaffirmed by E.O. 13563, “Improving Regulation and Regulatory Review,” 76 FR 3821 (Jan. 21, 2011) and amended by E.O. 14094, “Modernizing Regulatory Review,” 88 FR 21879 (April 11, 2023), requires agencies, to the extent permitted by law, to (1) propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify); (2) tailor regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations; (3) select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) to the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt; and (5) identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees or marketable permits, or providing information upon which choices can be made by the public. DOE emphasizes as well that E.O. 13563 requires agencies to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible. In its guidance, the Office of Information and Regulatory Affairs (OIRA) has emphasized that such techniques may include identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes. For the reasons stated in this preamble, this regulatory action is consistent with these principles.

Section 6(a) of E.O. 12866 requires agencies to submit “significant regulatory actions” to OIRA for review. OIRA has determined that this regulatory action is not a “significant regulatory action” within the scope of E.O. 12866. Accordingly, this action is not subject to review under E.O. 12866 by OIRA of the Office of Management and Budget (OMB).

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq. ) requires that an agency prepare an initial regulatory flexibility analysis for any regulation for which a final rule is required, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities (5 U.S.C. 605(b)). As required by Executive Order 13272, Proper Consideration of Small Entities in Agency Rulemaking, 67 FR 53461 (Aug. 16, 2002), DOE published procedures and policies on February 19, 2003, to ensure that the potential impacts of its rules on small entities are properly considered during the rulemaking process. 68 FR 7990. DOE has made its procedures and policies available on the Office of the General Counsel's website ( www.energy.gov/gc/office-general-counsel ).

DOE reviewed this final rule under the provisions of the Regulatory Flexibility Act and the procedures and policies published on February 19, 2003. DOE certifies that the final rule, if adopted, would not have significant economic impact on a substantial number of small entities. The factual basis for this certification is set forth below.

This final rule would update DOE's policies and procedures concerning the disclosure of records held within a system of records pursuant to the Privacy Act of 1974. This final rule would apply only to activities conducted by DOE's Federal employees and contractors, who would be responsible for implementing the rule requirements. DOE does not expect there to be any potential economic impact of this final rule on small businesses. Small businesses, therefore, should not be adversely impacted by the requirements in this final rule. For these reasons, DOE certifies that this final rule will not have a significant economic impact on a substantial number of small entities, and therefore, no regulatory flexibility analysis has been prepared.

This final rule does not impose a collection of information requirement subject to review and approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

Pursuant to the National Environmental Policy Act of 1969 (NEPA), DOE has analyzed this action in accordance with NEPA and DOE's NEPA implementing regulations (10 CFR part 1021). DOE's regulations include a categorical exclusion (CX) for rulemakings interpreting or amending an existing rule or regulation that does not change the environmental effect of the rule or regulation being amended. 10 CFR part 1021, subpart D, appendix A5. DOE has determined that this final rule is covered under the CX found in DOE's NEPA regulations at paragraph A.5 of appendix A to subpart D, 10 CFR part 1021, because it is an amendment to an existing regulation that does not change the environmental effect of the amended regulation and, therefore, meets the requirements for the application of this CX. See 10 CFR 1021.410. Therefore, DOE has determined that this final rule is not a major Federal action significantly affecting the quality of the human environment within the meaning of NEPA and does not require an Environmental Assessment or an Environmental Impact Statement.

With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (February 7, 1996), imposes on Federal agencies the general duty to adhere to the following requirements: (1) eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; (3) provide a clear legal standard for affected conduct rather than a general standard; and (4) promote simplification and burden reduction. Section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure the regulation: (1) clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for the affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; (6) specifies whether administrative proceedings are to be required before parties may file suit in court and, if so, describes those proceedings and requires the exhaustion of administrative remedies; and (7) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of the standards. DOE has completed the required review and determined that, to the extent permitted by law, this final rule meets the relevant standards of Executive Order 12988.

Executive Order 13132, “Federalism,” 64 FR 43255 (August 10, 1999) imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. Agencies are required to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and carefully assess the necessity for such actions. The Executive order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. DOE has examined this final rule and has tentatively determined that it would not preempt State law and would not have 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. No further action is required by Executive Order 13132.

Under Executive Order 13175 (65 FR 67249, November 6, 2000) on “Consultation and Coordination with Indian Tribal Governments,” DOE may not issue a discretionary rule that has “Tribal” implications and imposes substantial direct compliance costs on Indian Tribal governments. DOE has determined that this final rule would not have such effects and concluded that Executive Order 13175 does not apply to this final rule.

Title II of the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4) requires each Federal agency to assess the effects of a Federal regulatory action on State, local, and Tribal governments, and the private sector. (Pub. L. 104-4, sec. 201 et seq. (codified at 2 U.S.C. 1531 et seq. )). For a regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a “significant Federal intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect them. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. (62 FR 12820) (This policy is also available at: www.energy.gov/gc/guidance-opinions under “Guidance & Opinions” (Rulemaking)). DOE examined the final rule according to UMRA and its statement of policy and has determined that the rule contains neither an intergovernmental mandate, nor a mandate that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year. Accordingly, no further assessment or analysis is required under UMRA.

DOE has determined, under Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights” 53 FR 8859 (March 18, 1988), that this regulation would not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001) requires Federal agencies to prepare and submit to the OIRA, which is part of OMB, a Statement of Energy Effects for any significant energy action. A “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to promulgation of a final rule, and that: (1)(i) is a significant regulatory action under Executive Order 12866, or any successor order; and (ii) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (2) is designated by the Administrator of OIRA as a significant energy action. For any significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use. This regulatory action is not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects.

Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any final rule that may affect family well-being. This final rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516) provides for Federal agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (February 22, 2002), and DOE's guidelines were published at 67 FR 62446 (October 7, 2002). Pursuant to OMB Memorandum M-19-15, Improving Implementation of the Information Quality Act (April 24, 2019), DOE published updated guidelines which are available at: www.energy.gov/sites/prod/files/2019/12/f70/DOE%20Final%20Updated%20IQA%20Guidelines%20Dec%202019.pdf.

DOE has reviewed this final rule and will ensure that information produced under this regulation remains consistent with the applicable OMB and DOE guidelines.

As required by 5 U.S.C. 801, DOE will report to Congress on the promulgation of this rule prior to its effective date. The report will state that the rule does not, meet the criteria set forth in 5 U.S.C. 804(2).

The Secretary of Energy has approved publication of this final rule.

This document of the Department of Energy was signed on [December 11, 2024, by Ann Dunkin, Senior Agency Official for Privacy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

For the reasons set forth in the preamble, the Department of Energy amends part 1008 of chapter X of title 10 of the Code of Federal Regulations as set forth below:

On January 27, 2022, BETA applied for a type certificate for its Model H500A electric engines. The BETA Model H500A electric engine initially will be used as a “pusher” electric engine in a single-engine airplane that will be certified separately from the engine. A typical normal category general aviation aircraft locates the engine at the front of the fuselage. In this configuration, the propeller attached to the engine pulls the airplane along its flightpath. A pusher engine is located at the rear of the fuselage, so the propeller attached to the engine pushes the aircraft instead of pulling the aircraft.

The BETA Model H500A electric engine is comprised of a direct drive, radial-flux, permanent-magnet motor, divided in two sections, each section having a three-phase motor, and one electric power inverter controlling each three-phase motor. The magnets are arranged in a Halbach magnet array, and the stator is a concentrated, tooth-wound configuration. A stator is the stationary component in the electric engine that surrounds the rotating hardware; for example: the BETA propeller shaft, which consists of a bonded core with coils of insulated wire, known as the windings. When alternating current is applied to the coils of insulated wire in a stator, a rotating magnetic field is created, which provides the motive force for the rotating components.

Under the provisions of 14 CFR 21.17(a)(1), generally, BETA must show that Model H500A electric engines meet the applicable provisions of 14 CFR part 33 in effect on the date of application for a type certificate.

If the Administrator finds that the applicable airworthiness regulations ( e.g., part 33) do not contain adequate or appropriate safety standards for the BETA Model H500A electric engines because of a novel or unusual design feature, special conditions may be prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other engine model that incorporates the same novel or unusual design feature, these special conditions would also apply to the other engine model under § 21.101.

The FAA issues special conditions, as defined in § 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.17(a)(2).

The BETA Model H500A electric engines will incorporate the following novel or unusual design features:

An electric motor, motor controller, and high-voltage electrical systems that are used as the primary source of propulsion for an aircraft.

Electric propulsion technology is substantially different from the technology used in previously certificated turbine and reciprocating engines. Therefore, these engines introduce new safety concerns that need to be addressed in the certification basis.

The BETA Model H500A electric engines have a novel or unusual design feature, which is the use of electrical sources of energy instead of fuel to drive the mechanical systems that provide propulsion for aircraft. Therefore, part 33 does not contain adequate or appropriate safety standards for the BETA Model H500A electric engine's novel or unusual design feature.

BETA's aircraft engines will operate using electrical power instead of air and fuel combustion to propel the aircraft. These electric engines will be designed, manufactured, and controlled differently than turbine or reciprocating aircraft engines. They will be built with an electric motor, motor controller, and high-voltage electrical systems that draw energy from electrical storage or electrical energy generating systems. The electric motor is a device that converts electrical energy into mechanical energy by electric current flowing through windings (wire coils) in the motor, producing a magnetic field that interacts with permanent magnets mounted on the engine's main rotor. The controller is a system that consists of two main functional elements: the motor controller and an electric power inverter to drive the motor. 1 The high-voltage electrical system is a combination of wires and connectors that integrate the motor and controller.

In addition, the technology comprising these high-voltage and high-current electronic components introduces potential hazards that do not exist in turbine and reciprocating aircraft engines. For example, high-voltage transmission lines, electromagnetic shields, magnetic materials, and high-speed electrical switches are necessary to use the physical properties of an electric engine for propelling an aircraft.

The requirements in part 33 ensure that the design and construction of aircraft engines, including the engine control systems, are proper for the type of aircraft engines considered for certification. However, part 33 does not fully address aircraft engines like the BETA Model H500A, which operates using electrical technology as the primary means of propelling the aircraft.

The requirements in part 33, subpart B, are applicable to reciprocating and turbine aircraft engines. Subparts C and D are applicable to reciprocating aircraft engines. Subparts E through G are applicable to turbine aircraft engines. As such, subparts B through G do not adequately address the use of aircraft engines that operate using electrical technology. Special conditions are needed to ensure a level of safety for electric engines that is commensurate with these subparts, as those regulatory requirements do not contain adequate or appropriate safety standards for electric aircraft engines that are used to propel aircraft.

The FAA proposed special conditions and received comments from many commenters. Some comments resulted in changes to the special conditions. These changes are explained in the Discussion of Comments.

Applicability: Special condition no. 1 requires BETA to comply with part 33, except for those airworthiness standards specifically and explicitly applicable only to reciprocating and turbine aircraft engines.

Engine Ratings and Operating Limitations: Special condition no. 2, in addition to compliance with § 33.7(a), requires BETA to establish engine operating limits related to the power, torque, speed, and duty cycles specific to BETA Model H500A electric engines. The duty or duty cycle is a statement of the load(s) to which the engine is subjected, including, if applicable, starting, no-load and rest, and de-energized periods, including their durations or cycles and sequence in time. This special condition also requires BETA to declare cooling fluid grade or specification, power supply requirements, and to establish any additional ratings that are necessary to define the BETA Model H500A electric engine capabilities required for safe operation of the engine.

Materials: Special condition no. 3 requires BETA to comply with § 33.15, which sets requirements for the suitability and durability of materials used in the engine, and which would otherwise be applicable only to reciprocating and turbine aircraft engines.

Fire Protection: Special condition no. 4 requires BETA to comply with § 33.17, which sets requirements to protect the engine and certain parts and components of the airplane against fire, and which would otherwise be applicable only to reciprocating and turbine aircraft engines. Additionally, this special condition requires BETA to ensure that the high-voltage electrical wiring interconnect systems that connect the controller to the motor are protected against arc faults. An arc fault is a high-power discharge of electricity between two or more conductors. This discharge generates heat, which can break down the wire's insulation and trigger an electrical fire. Arc faults can range in power from a few amps up to thousands of amps and are highly variable in strength and duration.

Durability: Special condition no. 5 requires the design and construction of BETA Model H500A electric engines to minimize the development of an unsafe condition between maintenance intervals, overhaul periods, and mandatory actions described in the Instructions for Continued Airworthiness (ICA).

Engine Cooling: Special condition no. 6 requires BETA to comply with § 33.21, which requires the engine design and construction to provide necessary cooling, and which would otherwise be applicable only to reciprocating and turbine aircraft engines. Additionally, this special condition requires BETA to document the cooling system monitoring features and usage in the engine installation manual (see § 33.5) if cooling is required to satisfy the safety analysis described in special condition no. 17. Loss of cooling to an aircraft engine that operates using electrical technology can result in rapid overheating and abrupt engine failure, with critical consequences to safety.

Engine Mounting Attachments and Structure: Special condition no. 7 requires BETA and the design to comply with § 33.23, which requires the applicant to define, and the design to withstand, certain load limits for the engine mounting attachments and related engine structure. These requirements would otherwise be applicable only to reciprocating and turbine aircraft engines.

Accessory Attachments: Special condition no. 8 requires the design to comply with § 33.25, which sets certain design, operational, and maintenance requirements for the engine's accessory drive and mounting attachments, and which would otherwise be applicable only to reciprocating and turbine aircraft engines.

Rotor Overspeed: Special condition no. 9 requires BETA to establish by test, validated analysis, or a combination of both, that—

(1) the rotor overspeed must not result in a burst, rotor growth, or damage that results in a hazardous engine effect;

(2) rotors must possess sufficient strength margin to prevent burst; and

(3) operating limits must not be exceeded in service.

The special condition associated with rotor overspeed is necessary because of the differences between turbine engine technology and the technology of these electric engines. Turbine rotor speed is driven by expanding gas and aerodynamic loads on rotor blades. Therefore, the rotor speed or overspeed results from interactions between thermodynamic and aerodynamic engine properties. The speed of an electric engine is directly controlled by electric current, and an electromagnetic field created by the controller. Consequently, electric engine rotor response to power demand and overspeed-protection systems is quicker and more precise. Also, the failure modes that can lead to overspeed between turbine engines and electric engines are vastly different, and therefore this special condition is necessary.

Engine Control Systems: Special condition no. 10(b) requires BETA to ensure that these engines do not experience any unacceptable operating characteristics, such as unstable speed or torque control, or exceed any of their operating limitations.

The FAA originally issued § 33.28 at amendment 33-15 to address the evolution of the means of controlling the fuel supplied to the engine, from carburetors and hydro-mechanical controls to electronic control systems. These electronic control systems grew in complexity over the years, and as a result, the FAA amended § 33.28 at amendment 33-26 to address these increasing complexities. The controller that forms the controlling system for these electric engines is significantly simpler than the complex control systems used in modern turbine engines. The current regulations for engine control are inappropriate for electric engine control systems; therefore, special condition no. 10(b) associated with controlling these engines is necessary.

Special condition no. 10(c) requires BETA to develop and verify the software and complex electronic hardware used in programmable logic devices, using proven methods that ensure that the devices can provide the accuracy, precision, functionality, and reliability commensurate with the hazard that is being mitigated by the logic. RTCA DO-254, “Design Assurance Guidance for Airborne Electronic Hardware,” dated April 19, 2000, 2 distinguishes between complex and simple electronic hardware.

Special condition no. 10(d) requires data from assessments of all functional aspects of the control system to prevent errors that could exist in software programs that are not readily observable by inspection of the code. Also, BETA must use methods that will result in the expected quality that ensures the engine control system performs the intended functions throughout the declared operational envelope.

The environmental limits referred to in special condition no. 10(e) include temperature, vibration, high-intensity radiated fields (HIRF), and all others addressed in RTCA DO-160G, “Environmental Conditions and Test Procedures for Airborne Electronic/Electrical Equipment and Instruments,” dated December 8, 2010, which includes RTCA DO-160G, Change 1—“Environmental Conditions and Test Procedures for Airborne Equipment,” dated December, 16, 2014, and DO-357, “User Guide: Supplement to DO-160G,” dated December 16, 2014. 3 Special condition 10(e) requires BETA to demonstrate by system or component tests in special condition no. 27 any environmental limits that cannot be adequately substantiated by the endurance demonstration, validated analysis, or a combination thereof.

Special condition no. 10(f) requires BETA to evaluate various control system failures to ensure that such failures will not lead to unsafe engine conditions. The FAA issued Advisory Circular (AC) 33.28-3, “Guidance Material for 14 CFR 33.28, Engine Control Systems,” on May 23, 2014 (AC 33.28-3), for reciprocating and turbine engines. 4 This AC provides guidance for defining an engine control system failure when showing compliance with the requirements of § 33.28. AC 33.28-3 also includes objectives for control system integrity requirements, criteria for a loss of thrust control (LOTC) and loss of power control (LOPC) event, and an acceptable LOTC/LOPC rate. The electrical and electronic failures and failure rates did not account for electric engines when the FAA issued this AC, and therefore performance-based special conditions are established to allow fault accommodation criteria to be developed for electric engines.

The phrase “in the full-up configuration” used in special condition no. 10(f)(2) refers to a system without any fault conditions present. The electronic control system must, when in the full-up configuration, be single-fault tolerant, as determined by the Administrator, for electrical, electrically detectable, and electronic failures involving LOPC events.

The term “local” in the context of “local events” used in special condition no. 10(f)(4) means failures or malfunctions leading to events in the intended aircraft installation such as fire, overheat, or failures leading to damage to engine control system components. These “local events” must not result in a hazardous engine effect due to engine control system failures or malfunctions.

Special condition no. 10(g) requires BETA to conduct a safety assessment of the control system to support the safety analysis in special condition no. 17. This control system safety assessment provides engine response to failures, and rates of these failures that can be used at the aircraft-level safety assessment.

Special condition no. 10(h) requires BETA to provide appropriate protection devices or systems to ensure that engine operating limits will not be exceeded in service.

Special condition no. 10(i) is necessary to ensure that the controllers are self-sufficient and isolated from other aircraft systems. The aircraft-supplied data supports the analysis at the aircraft level to protect the aircraft from common mode failures that could lead to major propulsion power loss. The exception “other than power command signals from the aircraft,” noted in special condition no. 10(i), is based on the FAA's determination that the engine controller has no reasonable means to determine the validity of any in-range signals from the electrical power system. In many cases, the engine control system can detect a faulty signal from the aircraft, but the engine control system typically accepts the power command signal as a valid value.

The term “independent” in the context of “fully independent engine systems” referenced in special condition no. 10(i) means the controllers should be self-sufficient and isolated from other aircraft systems or provide redundancy that enables the engine control system to accommodate aircraft data system failures. In the case of loss, interruption, or corruption of aircraft-supplied data, the engine must continue to function in a safe and acceptable manner without hazardous engine effects.

The term “accommodated,” in the context of “detected and accommodated,” referenced in special condition 10(i)(2) is to assure that, upon detecting a fault, the system continues to function safely.

Special condition no. 10(j) requires BETA to show that the loss of electric power from the aircraft will not cause the electric engine to malfunction in a manner hazardous to the aircraft. The total loss of electric power to the electric engine may result in an engine shutdown.

Instrument Connection: Special condition no. 11 requires BETA to comply with § 33.29(a), (e), and (g), which set certain requirements for the connection and installation of instruments to monitor engine performance. The remaining requirements in § 33.29 apply only to technologies used in reciprocating and turbine aircraft engines.

Instrument connections (wires, wire insulation, potting, grounding, connector designs, etc.) must not introduce unsafe features or characteristics to the aircraft. Special condition no. 11 requires the safety analysis to include potential hazardous effects from failures of instrument connections to function properly. The outcome of this analysis might identify the need for design enhancements or additional ICA to ensure safety.

Stress Analysis: Section 33.62 requires applicants to perform a stress analysis on each turbine engine. This regulation is explicitly applicable only to turbine engines and turbine engine components, and it is not appropriate for the BETA Model H500A electric engines. However, a stress analysis particular to these electric engines is necessary to account for stresses resulting from electric technology used in the engine.

Special condition no. 12 requires a mechanical, thermal, and electrical stress analysis to show that the engine has a sufficient design margin to prevent unacceptable operating characteristics. Also, the applicant must determine the maximum stresses in the engine by tests, validated analysis, or a combination thereof, and show that they do not exceed minimum material properties.

Critical and Life-Limited Parts: Special condition no. 13 requires BETA to show whether rotating or moving components, bearings, shafts, static parts, and non-redundant mount components should be classified, designed, manufactured, and managed throughout their service life as critical or life-limited parts.

The term “low-cycle fatigue,” referenced in special condition no. 13(a)(2), is a decline in material strength from exposure to cyclic stress at levels beyond the stress threshold the material can sustain indefinitely. This threshold is known as the “material endurance limit.” Low-cycle fatigue typically causes a part to sustain plastic or permanent deformation during the cyclic loading and can lead to cracks, crack growth, and fracture. Engine parts that operate at high temperatures and high mechanical stresses simultaneously can experience low-cycle fatigue coupled with creep. Creep is the tendency of a metallic material to permanently move or deform when it is exposed to the extreme thermal conditions created by hot combustion gasses, and substantial physical loads such as high rotational speeds and maximum thrust. Conversely, high-cycle fatigue is caused by elastic deformation, small strains caused by alternating stress, and a much higher number of load cycles compared to the number of cycles that cause low-cycle fatigue.

The engineering plan referenced in special condition no. 13(b)(1) informs the manufacturing and service management processes of essential information that ensures the life limit of a part is valid. The engineering plan provides methods for verifying the characteristics and qualities assumed in the design data using methods that are suitable for the part criticality. The engineering plan informs the manufacturing process of the attributes that affect the life of the part. The engineering plan, manufacturing plan, and service management plan are related in that assumptions made in the engineering plan are linked to how a part is manufactured and how that part is maintained in service. For example, environmental effects on life limited electric engine parts, such as humidity, might not be consistent with the assumptions used to design the part. BETA must ensure that the engineering plan is complete, available, and acceptable to the Administrator.

The term “manufacturing plan,” referenced in special condition no. 13(b)(2), is the collection of data required to translate documented engineering design criteria into physical parts, and to verify that the parts comply with the properties established by the design data. Because engines are not intentionally tested to failure during a certification program, documents and processes used to execute production and quality systems required by § 21.137 guarantee inherent expectations for performance and durability. These systems limit the potential manufacturing outcomes to parts that are consistently produced within design constraints.

The manufacturing plan and service management plan ensure that essential information from the engineering plan, such as the design characteristics that safeguard the integrity of critical and life-limited parts, is consistently produced and preserved over the lifetime of those parts. The manufacturing plan includes special processes and production controls to prevent inclusion of manufacturing-induced anomalies, which can degrade the part's structural integrity. Examples of manufacturing-induced anomalies are material contamination, unacceptable grain growth, heat-affected areas, and residual stresses.

The service-management plan ensures the method and assumptions used in the engineering plan to determine the part's life remain valid by enabling corrections identified from in-service experience, such as service-induced anomalies and unforeseen environmental effects, to be incorporated into the design process. The service-management plan also becomes the ICA for maintenance, overhaul, and repairs of the part.

Lubrication System: Special condition no. 14 requires BETA to ensure that the lubrication system is designed to function properly between scheduled maintenance intervals and to prevent contamination of the engine bearings. This special condition also requires BETA to demonstrate the unique lubrication attributes and functional capability of the BETA Model H500A electric engine design.

The corresponding part 33 regulations include provisions for lubrication systems used in reciprocating and turbine engines. The part 33 requirements account for safety issues associated with specific reciprocating and turbine engine system configurations. These regulations are not appropriate for the BETA Model H500A electric engines. For example, electric engines do not have a crankcase or lubrication oil sump. Electric engine bearings are sealed, so they do not require an oil circulation system. The lubrication system in these engines is also independent of the propeller pitch control system. Therefore, special condition no. 14 incorporates only certain requirements from the part 33 regulations.

Power Response: Special condition no. 15 requires the design and construction of the BETA Model H500A electric engines to enable an increase from the minimum—

(1) power setting to the highest rated power without detrimental engine effects, and

(2) within a time interval appropriate for the intended aircraft application.

The engine control system governs the increase or decrease in power in combustion engines to prevent too much (or too little) fuel from being mixed with air before combustion. Due to the lag in rotor response time, improper fuel/air mixtures can result in engine surges, stalls, and exceedances above rated limits and durations. Failure of the combustion engine to provide thrust, maintain rotor speeds below rotor burst thresholds, and keep temperatures below limits can have engine effects detrimental to the aircraft. Similar detrimental effects are possible in the BETA Model H500A electric engines, but the causes are different. Electric engines with reduced power response time can experience insufficient thrust to the aircraft, shaft over-torque, and over-stressed rotating components, propellers, and critical propeller parts. Therefore, this special condition is necessary.

Continued Rotation: Special condition no. 16 requires BETA to design the Model H500A electric engines such that, if the main rotating systems continue to rotate after the engine is shut down while in-flight, this continued rotation will not result in any hazardous engine effects.

The main rotating system of the BETA Model H500A electric engines consists of the rotors, shafts, magnets, bearings, and wire windings that convert electrical energy to shaft torque. For the initial aircraft application, this rotating system must continue to rotate after the power source to the engine is shut down. The safety concerns associated with this special condition are substantial asymmetric aerodynamic drag that can cause aircraft instability, loss of control, and reduced efficiency; and may result in a forced landing or inability to continue safe flight.

Safety Analysis: Special condition no. 17 requires BETA to comply with § 33.75(a)(1) and (a)(2), which require the applicant to conduct a safety analysis of the engine, and which would otherwise be applicable only to turbine aircraft engines. Additionally, this special condition requires BETA to assess its engine design to determine the likely consequences of failures that can reasonably be expected to occur. The failure of such elements, and associated prescribed integrity requirements, must be stated in the safety analysis.

A primary failure mode is the manner in which a part is most likely going to fail. Engine parts that have a primary failure mode, a predictable life to the failure, and a failure consequence that results in a hazardous effect, are life-limited or critical parts. Some life-limited or critical engine parts can fail suddenly in their primary failure mode, from prolonged exposure to normal engine environments such as temperature, vibration, and stress, if those engine parts are not removed from service before the damage mechanisms progress to a failure. Due to the consequence of failure, these parts are not allowed to be managed by on-condition or probabilistic means because the probability of failure cannot be sensibly estimated in numerical terms. Therefore, the parts are managed by compliance with integrity requirements, such as mandatory maintenance (life limits, inspections, inspection techniques), to ensure the qualities, features, and other attributes that prevent the part from failing in its primary failure mode are preserved throughout its service life. For example, if the number of engine cycles to failure are predictable and can be associated with specific design characteristics, such as material properties, then the applicant can manage the engine part with life limits.

Complete or total power loss is not assumed to be a minor engine event, as it is in the turbine engine regulation § 33.75, to account for experience data showing a potential for higher hazard levels from power loss events in single-engine general aviation aircraft. The criteria in these special conditions apply to an engine that continues to operate at partial power after a single electrical or electronic fault or failure. Total loss of power is classified at the aircraft level using special condition nos. 10(g) and 33(h).

Ingestion: Special condition no. 18 requires BETA to ensure that these engines will not experience unacceptable power loss or hazardous engine effects from ingestion. The associated regulations for turbine engines, §§ 33.76, 33.77, and 33.78, are based on potential performance impacts and damage from birds, ice, rain, and hail being ingested into a turbine engine that has an inlet duct, which directs air into the engine for combustion, cooling, and thrust. By contrast, the BETA electric engines are not configured with inlet ducts.

An “unacceptable” power loss, as used in special condition no. 18(b), is such that the power or thrust required for safe flight of the aircraft becomes unavailable to the pilot. The specific amount of power loss that is required for safe flight depends on the aircraft configuration, speed, altitude, attitude, atmospheric conditions, phase of flight, and other circumstances where the demand for thrust is critical to safe operation of the aircraft.

Liquid and Gas Systems: Special condition no. 19 requires BETA to ensure that systems used for lubrication or cooling of engine components are designed and constructed to function properly. Also, if a system is not self-contained, the interfaces to that system would be required to be defined in the engine installation manual. Systems for the lubrication or cooling of engine components can include heat exchangers, pumps, fluids, tubing, connectors, electronic devices, temperature sensors and pressure switches, fasteners and brackets, bypass valves, and metallic chip detectors. These systems allow the electric engine to perform at extreme speeds and temperatures for durations up to the maintenance intervals without exceeding temperature limits or predicted deterioration rates.

Vibration Demonstration: Special condition no. 20 requires BETA to ensure the engine—

(1) is designed and constructed to function throughout its normal operating range of rotor speeds and engine output power without inducing excessive stress caused by engine vibration, and

(2) design undergoes a vibration survey.

The vibration demonstration is a survey that characterizes the vibratory attributes of the engine. It verifies that the stresses from vibration do not impose excessive force or result in natural frequency responses on the aircraft structure. The vibration demonstration also ensures internal vibrations will not cause engine components to fail. Excessive vibration force occurs at magnitudes and forcing functions or frequencies, which may result in damage to the aircraft. Stress margins to failure add conservatism to the highest values predicted by analysis for additional protection from failure caused by influences beyond those quantified in the analysis. The result of the additional design margin is improved engine reliability that meets prescribed thresholds based on the failure classification. The amount of margin needed to achieve the prescribed reliability rates depends on an applicant's experience with a product. The FAA considers the reliability rates when deciding how much vibration is “excessive.”

Overtorque: Special condition no. 21 requires BETA to demonstrate that the engine is capable of continued operation without the need for maintenance if it experiences a certain amount of overtorque.

BETA's electric engine converts electrical energy to shaft torque, which is used for propulsion. The electric motor, controller, and high-voltage systems control the engine torque. When the pilot commands power or thrust, the engine responds to the command and adjusts the shaft torque to meet the demand. During the transition from one power or thrust setting to another, a small delay, or latency, occurs in the engine response time. While the engine dwells in this time interval, it can continue to apply torque until the command to change the torque is applied by the engine control. The allowable amount of overtorque during operation depends on the engine's response to changes in the torque command throughout its operating range.

Calibration Assurance: Special condition no. 22 requires BETA to subject the engine to calibration tests to establish its power characteristics and the conditions both before and after the endurance and durability demonstrations specified in special condition nos. 23 and 26. The calibration test requirements specified in § 33.85 only apply to the endurance test specified in § 33.87, which is applicable only to turbine engines. The FAA determined that the methods used for accomplishing those tests for turbine engines are not appropriate for electric engines. The calibration tests in § 33.85 have provisions applicable to ratings that are not relevant to the BETA Model H500A electric engines. Special condition no. 22 allows BETA to demonstrate the endurance and durability of the electric engine either together or independently, whichever is most appropriate for the engine qualities being assessed. Consequently, the special condition applies the calibration requirement to both the endurance and durability tests.

Endurance Demonstration: Special condition no. 23 requires BETA to perform an endurance demonstration test that is acceptable to the Administrator. The Administrator will evaluate the extent to which the test exposes the engine to failures that could occur when the engine is operated at up to its rated values, and determine if the test is sufficient to show that the engine design will not exhibit unacceptable effects in service, such as significant performance deterioration, operability restrictions, and engine power loss or instability, when it is run repetitively at rated limits and durations in conditions that represent extreme operating environments.

Temperature Limit: Special condition no. 24 requires BETA to ensure the engine can endure operation at its temperature limits plus an acceptable margin. An “acceptable margin,” as used in the special condition, is the amount of temperature above that required to prevent the least capable engine allowed by the type design, as determined by § 33.8, from failing due to temperature-related causes when operating at the most extreme engine and environmental thermal conditions.

Operation Demonstration: Special condition no. 25 requires the engine to demonstrate safe operating characteristics throughout its declared flight envelope and operating range. Engine operating characteristics define the range of functional and performance values the BETA Model H500A electric engines can achieve without incurring hazardous effects. The characteristics are requisite capabilities of the type design that qualify the engine for installation into aircraft and that determine aircraft installation requirements. The primary engine operating characteristics are assessed by the tests and demonstrations that would be required by these special conditions. Some of these characteristics are shaft output torque, rotor speed, power consumption, and engine thrust response. The engine performance data BETA will use to certify the engine must account for installation loads and effects. These are aircraft-level effects that could affect the engine characteristics that are measured when the engine is tested on a stand or in a test cell. These effects could result from elevated inlet cowl temperatures, aircraft maneuvers, flowstream distortion, and hard landings. For example, an engine that is run in a sea-level, static test facility could demonstrate more capability for some operating characteristics than it will have when operating on an aircraft in certain flight conditions. Discoveries like this during certification could affect engine ratings and operating limits. Therefore, the installed performance defines the engine performance capabilities.

Durability Demonstration: Special condition no. 26 requires BETA to subject the engine to a durability demonstration. The durability demonstration must show that the engine is designed and constructed to minimize the development of any unsafe condition between maintenance intervals or between engine replacement intervals if maintenance or overhaul is not defined. The durability demonstration also verifies that the ICA is adequate to ensure the engine, in its fully deteriorated state, continues to generate rated power or thrust, while retaining operating margins and sufficient efficiency, to support the aircraft safety objectives. The amount of deterioration an engine can experience is restricted by operating limitations and managed by the engine ICA. Section 33.90 specifies how maintenance intervals are established; it does not include provisions for an engine replacement. Electric engines and turbine engines deteriorate differently; therefore, BETA will use different test effects to develop maintenance, overhaul, or engine replacement information for their electric engine.

System and Component Tests: Special condition no. 27 requires BETA to show that the systems and components of the engine perform their intended functions in all declared engine environments and operating conditions.

Sections 33.87 and 33.91, which are specifically applicable to turbine engines, have conditional criteria to decide if additional tests will be required after the engine tests. The criteria are not suitable for electric engines. Part 33 associates the need for additional testing with the outcome of the § 33.87 endurance test because it is designed to address safety concerns in combustion engines. For example, § 33.91(b) requires the establishment of temperature limits for components that require temperature-controlling provisions, and § 33.91(a) requires additional testing of engine systems and components where the endurance test does not fully expose internal systems and components to thermal conditions that verify the desired operating limits. Exceeding temperature limits is a safety concern for electric engines. The FAA determined that the § 33.87 endurance test is not appropriate for testing the electronic components of electric engines because mechanical energy is generated differently by electronic systems than it is by the thermal conditions in turbine engines. Additional safety considerations also need to be addressed in the test. Therefore, special condition no. 27 is a performance-based requirement that allows BETA to determine when engine systems and component tests are necessary and to determine the appropriate limitations of those systems and components used in the BETA Model H500A electric engine.

Rotor Locking Demonstration: Special condition no. 28 requires the engine to demonstrate reliable rotor locking performance and that no hazardous effects will occur if the engine uses a rotor locking device to prevent shaft rotation.

Some engine designs enable the pilot to prevent a propeller shaft or main rotor shaft from turning while the engine is running, or the aircraft is in-flight. This capability is needed for some installations that require the pilot to confirm the functionality of certain flight systems before takeoff. The BETA engine installations are not limited to aircraft that will not require rotor locking. Section 33.92 prescribes a test that may not include the appropriate criteria to demonstrate sufficient rotor locking capability for these engines. Therefore, this special condition is necessary.

The special condition does not define “reliable” rotor locking but allows BETA to classify the hazard as major or minor and assign the appropriate quantitative criteria that meet the safety objectives required by special condition no. 17 and the applicable portions of § 33.75.

Teardown Inspection: Special condition no. 29 requires BETA to perform a teardown or non-teardown evaluation after the endurance, durability, and overtorque demonstrations, based on the criteria in special condition no. 29(a) or (b).

Special condition no. 29(b) includes restrictive criteria for “non-teardown evaluations” to account for electric engines, sub-assemblies, and components that cannot be disassembled without destroying them. Some electrical and electronic components like BETA's are constructed in an integrated fashion that precludes the possibility of tearing them down without destroying them. The special condition indicates that, if a teardown cannot be performed in a non-destructive manner, then the inspection or replacement intervals must be established based on the endurance and durability demonstrations. The procedure for establishing maintenance should be agreed upon between the applicant and the FAA prior to running the relevant tests. Data from the endurance and durability tests may provide information that can be used to determine maintenance intervals and life limits for parts. However, if life limits are required, the lifing procedure is established by special condition no. 13, Critical and Life-Limited Parts, which corresponds to § 33.70. Therefore, the procedure used to determine which parts are life-limited, and how the life limits are established, requires FAA approval, as it does for § 33.70. Sections 33.55 and 33.93 do not contain similar requirements because reciprocating and turbine engines can be completely disassembled for inspection.

Containment: Special condition no. 30 requires the engine to have containment features that protect against likely hazards from rotating components unless BETA can show the margin to rotor burst does not justify the need for containment features. Rotating components in electric engines are typically disks, shafts, bearings, seals, orbiting magnetic components, and the assembled rotor core. However, if the margin to rotor burst does not unconditionally rule out the possibility of a rotor burst, then the special condition requires BETA to assume a rotor burst could occur and design the stator case to contain the failed rotors, and any components attached to the rotor that are released during the failure. In addition, BETA must also determine the effects of subsequent damage precipitated by a main rotor failure and characterize any fragments that are released forward or aft of the containment features. Further, decisions about whether the BETA engine requires containment features, and the effects of any subsequent damage following a rotor burst, should be based on test or validated analysis. The fragment energy levels, trajectories, and size are typically documented in the installation manual because the aircraft will need to account for the effects of a rotor failure in the aircraft design. The intent of this special condition is to prevent hazardous engine effects from structural failure of rotating components and parts that are built into the rotor assembly.

General Conduct of Tests: Special condition no. 32 requires BETA to—

(1) Include any scheduled maintenance.

(2) Include any maintenance, in addition to the scheduled maintenance, which was needed during the test to satisfy the applicable test requirements; and

(3) Conduct any additional tests that the Administrator finds necessary, as warranted by the test results.

For example, certification endurance test shortfalls might be caused by omitting some prescribed engine test conditions, or from accelerated deterioration of individual parts arising from the need to force the engine to operating conditions that drive the engine above the engine cycle values of the type design. If an engine part fails during a certification test, the entire engine might be subjected to penalty runs, with a replacement or newer part design installed on the engine, to meet the test requirements. Also, the maintenance performed to replace the part, so that the engine could complete the test, would be included in the engine ICA. In another example, if the applicant replaces a part before completing an engine certification test because of a test facility failure and can substantiate the part to the Administrator through bench testing, they might not need to substantiate the part design using penalty runs with the entire engine.

The term “excessive” is used to describe the frequency of unplanned engine maintenance, and the frequency of unplanned test stoppages, to address engine issues that prevent the engine from completing the tests in special condition nos. 32(b)(1) and (2), respectively. Excessive frequency is an objective assessment from the FAA's analysis of the amount of unplanned maintenance needed for an engine to complete a certification test. The FAA's assessment may include the reasons for the unplanned maintenance, such as the effects test facility equipment may have on the engine, the inability to simulate a realistic engine operating environment, and the extent to which an engine requires modifications to complete a certification test. In some cases, the applicant may be able to show that unplanned maintenance has no effect on the certification test results, or they might be able to attribute the problem to the facility or test-enabling equipment that is not part of the type design. In these cases, the ICA will not be affected. However, if BETA cannot reconcile the amount of unplanned service, then the FAA may consider the unplanned maintenance required during the certification test to be “excessive,” prompting the need to add the unplanned maintenance to mandatory ICA to comply with the certification requirements.

Engine electrical systems: The current requirements in part 33 for electronic engine control systems were developed to maintain an equivalent level of safety demonstrated by engines that operate with hydromechanical engine control systems. At the time § 33.28 was codified, the only electrical systems used on turbine engines were low-voltage, electronic engine control systems (EEC) and high-energy spark-ignition systems. Electric aircraft engines use high-voltage, high-current electrical systems and components that are physically located in the motor and motor controller. Therefore, the existing part 33 control system requirements do not adequately address all the electrical systems used in electric aircraft engines. Special condition no. 33 is established using the existing engine control systems requirement as a basis. It applies applicable airworthiness criteria from § 33.28 and incorporates airworthiness criteria that recognize and focus on the electrical power system used in the engine.

Special condition no. 33(b) ensures that all aspects of an electrical system, including generation, distribution, and usage, do not experience any unacceptable operating characteristics.

Special condition no. 33(c) requires the electrical power distribution aspects of the electrical system to provide the safe transfer of electrical energy throughout the electric engine.

The term “abnormal conditions” used in special condition no. 33(c)(2) is based on the term “abnormal operation” used in MIL-STD-704F “Aircraft Electric Power Characteristics” which defines normal operation and abnormal operation. MIL-STD-704F is a standard that ensures compatibility between power sources that provide power to the aircraft's electrical systems and airborne equipment that receive power from the power source. This standard also establishes technical criteria for aircraft electric power. The term “abnormal conditions” refers to various engine operating conditions such as:

• System or component characteristics outside of normal statistical variation from circumstances such as systems degradation, installation error, and engine response to fault conditions;

• Unusual environmental conditions from extreme temperature, humidity, vibration, lightning, high-intensity radiated field (HIRF), atmospheric neutron radiation; and

• Unusual and infrequent events such as landing on icy runways, rejected take-offs or go-arounds, extended ground idling or taxiing in a hot environment, and abrupt load changes from foreign object damage or engine contamination.

The phrase “safe transmission of electric energy” used in special condition no. 33(c)(3) refers to the transmission of electrical energy in a manner that supports the operation of the electric engine(s) and the aircraft safety objectives without detrimental effects such as uncontrolled fire or structural failure due to severe overheating.

Special condition no. 33(d) requires the engine electrical system to be designed such that the loss, malfunction, or interruption of the electrical power source, or power conditions that exceed design limits, will not result in a hazardous engine effect.

Special condition no. 33(e) requires BETA to identify and declare, in the engine installation manual, the characteristics of any electrical power supplied from the aircraft to the engine, or electrical power supplied from the engine to the aircraft via energy regeneration, and any other characteristics necessary for safe operation of the engine.

Special condition no. 33(f) requires BETA to demonstrate that systems and components will operate properly up to environmental limits, using special conditions, when such limits cannot be adequately substantiated by the endurance demonstration, validated analysis, or a combination thereof. The environmental limits referred to in this special condition include temperature, vibration, HIRF, and all others addressed in RTCA DO-160G, “Environmental Conditions and Test Procedures for Airborne Electronic/Electrical Equipment and Instruments.”

Special condition 33(g) requires BETA to evaluate various electric engine system failures to ensure that these failures will not lead to unsafe engine conditions. The evaluation includes single-fault tolerance, ensures no single electrical or electronic fault or failure would result in hazardous engine effects, and ensures that any failure or malfunction leading to local events in the intended aircraft application does not result in certain hazardous engine effects. The special condition also implements integrity requirements, criteria for LOTC/LOPC events, and an acceptable LOTC/LOPC rate.

Special condition 33(h) requires BETA to conduct a safety assessment of the engine electrical system to support the safety analysis in special condition no. 17. This safety assessment provides engine response to failures, and rates of these failures, which can be used at the aircraft safety assessment level.

The FAA issued a notice of proposed special conditions (NPSC) Docket No. FAA-2022-1641 for the BETA Model H500A electric engines, which was published in the Federal Register on March 7, 2024 (89 FR 16474).

The FAA received comments from Transport Canada (TC), Transport Canada Civil Aviation (TCCA), United Parcel Service Flight Forward (UPSFF), Association for Uncrewed Vehicle Systems International (AUVSI), magniX USA, Inc. (magniX), General Aviation Manufacturers Association (GAMA), an individual, and an anonymous commenter.

The FAA received comments from TCCA.

TCCA indicated the discussion of proposed special condition no.10(e), Environmental limits of engine cooling systems, in the preamble states that the environmental limits referred to in this special condition are addressed in RTCA DO-160G. However, TCCA explained that some of the existing RTCA DO-160G test specifications, methods, and categories may not be adequate for high voltage systems, such as the high voltage components of this engine. Accordingly, TCCA recommended adding the language “or other appropriate industry standards” at the end of the discussion of special condition no. 10(e) in the preamble.

The FAA does not agree with the recommended change. Although RTCA DO-160G is not sufficient for the high voltage systems used in the BETA Model H500A electric engine motor and inverter/controller, tests that are appropriate for the BETA engine will be developed in accordance with special condition nos. 1(b) and 1(c) using the testing techniques in RTCA DO-160G and other aerospace environmental documents. Independent tests are done for radiated and conducted susceptibility and compared to the RTCA DO-160G HIRF spectrum for susceptibility to ensure all electric engine radio frequency energy emissions inherent to the engine design are addressed. If the equipment under test passes the emission test in RTCA-DO-160 the susceptibility spectrum is covered by RTCA DO-160G. The applicant can use the RTCA DO-160G test. If not, the spectrum from the emission test would be analyzed and could be adjusted for the applicant's design and applied during the susceptibility test with FAA concurrence. No changes were made to these special conditions as a result of this comment.

TCCA also indicated special condition no. 2, Engine ratings and operating limits, should require that component life be considered when establishing the engine operating limits. They explained, the engine system or the electrical motor design may have components or parts that require a life limit. For example, the insulation on the high voltage system wiring may degrade with time and operating conditions. TCCA requested the FAA add “(f) Component life” to special condition no. 2, Engine Ratings and Operating Limits, and explained that component life should be considered when establishing the engine operating limits, similar to § 33.07(b)(7).

The FAA does not concur with TCCA's request. Component life is an expected outcome of special conditions nos. 13 (Critical and life-limited parts) and 17 (Safety analysis). Special condition no. 17 determines whether special condition no. 13 applies to the engine part. Special condition no 13 determines the mandatory replacement times (component life) and implements a maintenance program to manage these parts composed of an engineering plan, manufacturing plan, and service management plan. No changes were made to these special conditions as a result of this comment.

TCCA requested the FAA confirm that special condition no. 33(a), applicability for engine electrical systems, is not applicable to energy storage systems (ESS) but it does include the interface between the electric engine and the propulsion power source. TCCA further explained this comment is a request for clarification, rather than modification, of this special condition.

Special condition no. 33 does not apply to ESS but does apply to the interface between the engine and ESS. No changes were made to these special conditions as a result of this comment.

TCCA stated that proposed special condition no. 33(b), Electrical systems, is written in a way that implies electrical load shedding is mandatory even when not needed and explained electrical load shedding should only be implemented if required. TCCA recommended adding “if required” between parenthesis like the following: “. . . , and electrical load shedding (if required), . . .” to special condition no. 33(b).

The FAA concurs with TCCA's recommendation and has revised special condition no. 33(b) accordingly. Load shedding is a capability of the electric engine's power distribution system.

TCCA requested the FAA define the term “abnormal condition,” which is used in special condition 33(c)(2), Electrical power distribution, and offered several potential interpretations of the term. They also asked if an abnormal condition is any failure condition not considered extremely improbable, and if it is equivalent to the definition from MIL-STD-704F. The FAA's use of the term “abnormal conditions” does not refer to internal malfunctions or failures. It refers to operating conditions such as:

• System or components outside of normal statistical variation due to degradation, or installation error

• Unusual environmental conditions such as extreme temperature, humidity, FOD impact, severe lightning, HIRF, or atmospheric radiation

• Infrequent scenarios such as landing on icy runways, rejected take-offs or balked landings, extended ground idling, or taxiing in hot environments.

TCCA also requested the FAA provide a definition for “safe transmission,” which is used in special condition 33(c)(3).

The FAA concurs with TCCA's requests and has added definitions of the terms “abnormal condition” and “safe transmission” to the preamble discussion for special condition no. 33.

TCCA observed that proposed special condition nos. 33(e)(1) and (e)(2), Electrical power characteristics, were linked with an “or” indicating that either condition could be applied, but not both. TCCA stated both (e)(1) and (e)(2) are applicable, and therefore recommended the FAA revise special condition no. 33(e) to replace the “or” with an “and.”

The FAA concurs with TCCA's recommendation and has revised special condition no. 33(e) accordingly.

TCCA indicated that noise certification requirements are applicable at the airframe level and not at the engine level. TCCA explained the NPSC implies that an engine applicant demonstration of compliance to 14 CFR part 36 is part of the special conditions. However, TCCA stated there is no definition of requirements within the special conditions other than the preamble section titled the Type Certification Basis. TCCA requested that the FAA remove the statement “In addition to the applicable airworthiness regulations and special conditions, the BETA Model H500A electric engines must comply with the noise certification requirements of 14 CFR part 36” from the preamble. GAMA also commented on this issue and stated the noise certification requirements do not apply to engines and requested the FAA remove this statement from the preamble.

The FAA concurs with TCCA's and GAMA's requests and has updated the preamble of these special conditions accordingly.

TCCA suggested that the reference to “consensus standards” in proposed special condition 1(b), Applicability, may not be necessary. TCCA stated that consensus standards are not a means of compliance but instead, they are derived/alternate requirements ( i.e., ASTM) that are formulated by industry to be used in lieu of published regulatory guidance material. TCCA further suggested that the use of derived/alternate requirements in lieu of the published standards is to be accepted by the Administrator as being equivalent to the published standards. Then, the means of compliance to the consensus standards are to be accepted by the Administrator. TCCA recommended reducing the text in special condition no. 1(b) to the following: “(b) the applicant must comply with this part using a means of compliance accepted by the administrator.”

The FAA does not concur with TCCA's suggested change. The reference to consensus standards provides clarification about potential sources of information that may be used to determine a means of compliance. The comment indicates a need to clarify how consensus standards are used. For example, consensus standards developed by the standards development organizations (SDOs) typically function as a method of compliance to 14 CFR requirements or special conditions. Published FAA guidance can function either as a means of compliance, method of compliance, or both. Special condition 1(b) permits consensus standards to be used for showing compliance to certification requirements, but they are not a requirement of that special condition. Therefore, special condition 1(b) supplements the performance-based special conditions by requiring a means of compliance, which could include consensus standards developed by SDOs. Further, special condition 1(b) is intended to be equivalent to § 23.2010(a), which also refers to consensus standards as a potential means of compliance. No changes were made to the special conditions as a result of this comment.

TCCA observed the BETA proposed special condition no. 17 does not include a reference to § 33.75(a)(3) which appears in the magniX special conditions and recommended that the FAA explain this difference in the discussion for that special condition in the preamble to avoid ambiguity between the relative project requirements.

The FAA does not concur with TCCA's recommendation. The NPSC for the magniX magni350 and magni650 model electric engines originally proposed to incorporate § 33.75(a)(3) into special condition no. 17. The FAA received a comment suggesting that § 33.75(a)(3) may not be needed for those engines. In the final special conditions (Docket No. FAA-2020-0894, Special Conditions No. 33-022-SC), the FAA agreed with the comment and removed the reference to § 33.75(a)(3). No changes were made to these special conditions as a result of this comment.

The FAA received comments from TC.

TC disagreed with the text in proposed special condition nos. 17(a) and 17(c) which say, “The applicant must comply . . .” TC stated that the onus to show compliance with the applicable requirements with the intent to obtain a type certificate is on the applicant and that the elements that comply with the requirements themselves are those objects of the type certificate, such as the engine and its systems. TC further explained it is not clear to state that the applicant must comply, where it is in fact the engine/systems which must comply with the requirements. Instead, the applicant shows compliance. TC suggested changing the phrase to read “The applicant must show compliance . . .”

TC's proposed change is not necessary. Section 21.20, “Compliance with Applicable Requirements” contains an example that supports the language used in special conditions nos. 17(a) and (c). Specifically, § 21.20(b) specifies the applicant must “provide a statement certifying that the applicant has complied with the applicable requirements,” which indicates the applicant complies with the applicable requirements. . No changes were made as a result of this comment.

TC observed the text in proposed special condition no. 17(d)(1), Safety Analysis, does not include special condition no. 31, Operation with Variable Pitch Propeller. TC recommended that the FAA either add a reference to special condition no. 31 in special condition no. 17(d)(1) because BETA's electric engine may be installed with a variable pitch propeller or provide a rationale for not including it.

The FAA does not concur with TC's suggestion to add a reference to special condition no. 31. Adding special condition no. 31 is not necessary because the specific engine model BETA intends to certify is not designed to use a variable pitch propeller. No changes were made to the special conditions as a result of this comment.

TC indicated there is a similar electrical engine special condition in the magniX special conditions (Special Conditions No. 33-022-SC) that contains an ingestion requirement that does not appear in the BETA special conditions. TC referred to special condition no. 18(d) in the magniX special conditions, which requires ingestion sources that are not evaluated must be declared in the engine installation manual. TC recommended that the FAA either revise the BETA special conditions to add this requirement or provide the rationale for not including it.

The FAA does not concur with TC's request to revise the BETA special conditions to include special condition no. 18(d) from the magniX special conditions. Special condition no. 18(d) was intended to ensure ingestion sources that are not applicable to an electric engine are enunciated in the engine documentation. The list of required ingestion sources in BETA special condition nos. 18(a) and (b) are more prescriptive compared to the ingestion requirements in the published magniX special condition no. 18(a). Therefore, the FAA has determined special condition no. 18(d) is not necessary to include in the BETA special conditions because exceptions to the ingestion requirement would be specified and managed using special condition no. 18(c), which is similar to how exceptions are managed by the existing part 33 ingestion requirements. No changes were made to the special conditions as a result of this comment.

TC noted that proposed special condition no. 33(c)(1) introduces the term “electrical power plant” and recommended that the FAA update the preamble to describe an electrical power plant.

The FAA disagrees with TC's recommendation to define “electrical power plant” because the FAA revised special condition no. 33(c)(1) in these final special conditions to change the term “electrical power plant” to “powerplant,” as that term is defined in part 23, subpart E, in § 23.2400(a) powerplant installation, to include each component necessary for propulsion, which affects propulsion safety, or provides auxiliary power to the airplane, and in the installation requirements in subpart E of parts 25, 27, and 29.

TC observed that the proposed system safety assessments in proposed special condition no. 33(h), and proposed special condition no.10(g) are different in that special condition no. 10(g) requires the rates of hazardous and major faults to be declared in the engine installation manual and special condition no. 33(h) does not. TC recommended that the FAA either revise special condition no. 33(h) to match special condition no. 10(g) or provide a rationale for why they are different.

The FAA agrees with TC's recommendation and has revised final special condition no. 33(h) to match special condition no. 10(g).

The FAA received comments from GAMA.

GAMA recommended that the FAA align the special conditions for the H500A electric engine with the electric engine requirements included in the certification basis for special class powered lift aircraft that certify an electric engine as part of the aircraft type certification. GAMA stated that there are technical variations between the H500A proposed special conditions and the electric engine airworthiness criteria outlined in the Special Class Airworthiness Criteria for the powered-lift and cited special condition no. 17(c) and special condition no. 33(c) as examples of these technical differences. GAMA further stated these variations could lead to two electric engines used in the same aircraft having different requirements based solely on whether the engine is certified as part of the aircraft or under part 33. AUVSI also commented on the importance of applying consistent requirements across projects and requested the FAA substantiate any inconsistencies introduced to the electric engine requirements.

There are no intended technical differences between the proposed special class airworthiness criteria for the powered lift in draft Advisory Circular 21.17-4 (AC 21.17-4) and the BETA special conditions. For example, the corresponding criteria to BETA special condition nos. 17(c) and 33(c) are PL.3375(f) and PL.3326(c) respectively. The engine requirements are documented differently between the BETA special conditions and powered-lift airworthiness criteria proposed in draft AC 21.17-4 because special conditions are written in accordance with the requirements of § 21.16, and the powered-lift airworthiness criteria in draft AC 21.17-4 are not specific to one applicant. There are also some minor differences in the documentation requirements because engines are approved with the special class aircraft, so some engine details may be included in the aircraft manuals. No changes were made to the special conditions as a result of this comment.

GAMA indicated proposed special condition no. 9, Overspeed, lacks clarity regarding whether “rotor” refers to an internal electric engine component or an actual propulsive propeller. GAMA recommended the FAA provide the necessary clarification to address this ambiguity.

The FAA agrees with GAMA's recommendation. The term “rotor” in the proposed special conditions is intended to refer to an engine component and not a propulsive propeller. A rotor in an electric engine may consist of a circular disk and magnets fixed at the outer circumference that rotates inside a stationary casing configured with electrical windings (or coils), or a rotating cylindrical casing with magnets fixed on the inside surface that rotates around a stationary set of windings (or coils). Each configuration is attached to a rotating shaft that drives a propulsive device, such as a propeller. Project-specific decisions will be made regarding which engine parts are applicable to the overspeed requirement. No changes were made to the special conditions as a result of this comment.

GAMA stated that proposed special condition nos. 30(a) and (b), Containment, utilize language tailored to an engine design featuring a non-rotating stator situated outside the rotor. GAMA recommended the FAA explore a rule version that is less design-specific. GAMA advised against presuming that all rotating components possess a case, particularly that the rotor is contained within the stator.

The FAA does not concur with GAMA's recommendation Special condition 30(a) is intended to account for rotor designs with exceedingly large margins to a rotor burst. The special condition does not specify a particular rotor design. However, the amount of margin needed to satisfy the requirement would be determined based on the engine's design. Special condition 30(b) is intended to account for rotors located inside a static stator case. No changes were made to the special conditions as a result of this comment.

GAMA commented proposed special condition nos. 33(c)(1) and (c)(3), Electrical power distribution for engine electrical systems, set forth distinct criteria for the automatic measures needed when electrical-energy generation encounters faults, which diverges from the corresponding requirements in the special class airworthiness criteria for powered-lift. GAMA indicated there are no evident variations in electric engine configurations that warrant this inconsistency. GAMA recommended that the FAA align these regulations to ensure that electric engines certified as part of an aircraft or under part 33 adhere to uniform standards.

Proposed special condition nos. 33(c)(1) and (c)(3) are not the same as the corresponding engine requirements in the powered-lift airworthiness criteria used in another project. Proposed special condition no. 33(c)(1) protects engine electrical systems from faulted electrical energy generation or storage devices. Proposed special condition no. 33(c)(3) prescribes a means of compliance (fault isolation) to address (c)(1), but the means of compliance should be tied to the safety assessment required in special condition no. 33(g), which accounts for aircraft-level effects from faulted electrical-energy generation or storage devices. The aircraft effects should not be assumed in the engine requirements, and therefore the FAA revised special condition no. 33(c)(3) to accommodate other potential protection systems that might be more appropriate. Accordingly, final special condition no. 33(c)(3) is changed to, “The system must provide mechanical or automatic means of isolating a faulted electrical energy generation or storage device from leading to hazardous engine effects, as defined in special condition no. 17(d)(2) of these special conditions, or detrimental effects in the intended aircraft application.”

The phrase, “or detrimental engine effects in the intended aircraft application” was relocated to special condition no. 33(c)(3) to maintain the connection with special condition no. 33(g).

GAMA commented proposed special condition no. 33(g), Electrical system failures of engine electrical systems, extends beyond the comparable part 33 regulation § 33.28(d), which is originally limited to the engine control system. GAMA suggested that expanding this special condition to encompass the engine electrical system instead of solely the engine control system entails subjecting electrical components within the engine, such as windings, to failure requirements historically not applied to engine mechanical components. GAMA also stated that field experience indicates that component failures are unpredictable based on wear and susceptible to random failures. Electric engine components, like windings and insulation, are better addressed using methods akin to those applied to traditional engines to address mechanical failure aspects. GAMA recommended the FAA revise this special condition to align with the existing regulatory framework. The FAA does not concur with GAMA's recommendation. By their nature, FAA special conditions are issued when the “existing regulatory framework” is inadequate or insufficient. 14 CFR 21.16; see also Amdt. 21-51. The existing requirements for engine control systems were developed to address the failure characteristics of electrical systems. For combustion engines, the only electrical system is the engine control, but this is not the case for electric engines where electrical systems extend beyond those addressed by § 33.28(d). Special condition no. 33(g) for the BETA electric engine provides the same level of safety as § 33.28(d) by applying the safety criteria for electrical systems to all the electrical systems in the engine. This includes the high-voltage systems used in the electric engine. No changes were made to the special conditions as a result of this comment.

The FAA received several comments from an individual commenter and received similar comments from magniX (although these commenters provided separate comments).

An individual and magniX commented proposed special condition nos. 1(b) and (c) state that a means of compliance, which may include consensus standards, must be “accepted by the Administrator” and “in a form and manner acceptable to the Administrator.” The individual and magniX stated that these paragraphs are directly out of § 23.2010, which contains performance-based language. The individual and magniX considered the BETA electric engine special conditions to be largely prescriptive and not performance-based, which they stated would make special condition nos. 1(b) and (c) superfluous. The individual suggested these requirements introduce a new regulatory layer to prescriptive requirements and may lead to inadvertent consequences, while magniX stated that requiring a performance-based process for establishing means of compliance with prescriptive regulations is unnecessary and overly burdensome to applicants and regulators. The individual and magniX recommended the FAA not adopt proposed special condition nos. 1(b) and (c), and the individual also recommended holding public consultations with stakeholders as was done when part 23 was being reworked into a performance-based form.

The FAA does not concur with the individual's and magniX's recommendation. While special conditions are rules of particular, not general applicability, the FAA expects that special condition nos. 1(b) and (c) support the FAA's transition to a performance-based approach for developing new requirements. Although the BETA special conditions are not prescriptive, they provide safety criteria that address hazards presented by the new electric engine technology used in the BETA H500A engine. Special condition nos. 1(b) and (c) will be used to incorporate the additional details that apply to the BETA H500A engine design using accepted means of compliance. No changes were made to these special conditions as a result of this comment.

GAMA and magniX commented that special condition nos. 10(g), 15(b), and 17(f) would require applicants to declare proprietary information in the engine installation manual, these documentation requirements establish a precedent beyond that required of their existing reciprocating or turbine counterparts, and these requirements increase the risk that sensitive information is disclosed. MagniX stated that while it is understood this information is used during aircraft-level certification efforts, traditional data sharing agreements sufficiently provide the integrator with the required information while respecting the proprietary nature of the data. MagniX also stated requiring additional data in the engine installation manual overly constrains the means whereby this information is shared when compared with established means, introducing additional commercial risk. GAMA also stated proposed special condition nos. 10(g), 15(b), and 17(f) are a requirement for a manufacturer to disclose sensitive proprietary safety analysis in the engine installation manual, a requirement not currently imposed on part 33 engines. Additionally, GAMA stated the FAA has not provided adequate justification for why an electric engine necessitates this information in a manual. An individual provided a similar comment regarding proposed special condition nos. 10(g) and 17(f), and stated that historically such information was captured in other documents such as the engine control systems interface control document and systems safety assessment, that were only provided to the installer.

MagniX requested the FAA not adopt the documentation requirements in proposed special conditions 10(g), 15(b), and 17(f), and proposed that these data be provided to integrators through generic “installation instructions” in lieu of the engine installation manual. GAMA also requested the FAA reconsider its approach and/or provide justification for the added requirement of disclosing sensitive proprietary safety analysis in the engine installation manual. An individual requested the FAA preserve the engine OEM's flexibility to document and protect proprietary data by changing “installation manual” to the more generic “installation instructions,” which consist of other documents such as interface control drawings, technical memorandums, or other installer requested documentation. The individual further stated that this change would harmonize the special condition with § 23.2400(e) which uses the verbiage of “installation instructions,” and this change could be promulgated to other special condition paragraphs which refer to the engine installation manual.

The FAA does not concur with magniX's and GAMA's comments that special conditions 10(g), 15(b), and 17(f) require disclosing sensitive information. The requirements cited in their comment do not require disclosure of sensitive information. As discussed in the NPSC, the documentation requirements in special conditions nos. 10(g), 15(b), and 17(f) are expected to ensure that the engine is used safely and properly by constraining the installation of electric engines to only aircraft types (configurations, flight capabilities, etc.) that were used by the engine manufacturer to determine the engine ratings, limits, performance characteristics, as well as the reliability and criticality of engine systems and parts.

These documentation requirements are intended, and the FAA finds necessary, to ensure enough information is included to safeguard compatibility between the electric engine and aircraft, and to prevent the engine from being used in an aircraft type that requires safety features or performance characteristics that are not available from a type certificated engine. For example, electric engines designed for vertical lift in distributed propulsion tilt-wing aircraft provide propulsion and act as flight control surfaces, and therefore these engines have different performance requirements than those used in conventional normal category airplanes. In addition, the FAA agrees with the commenters' suggestion to remove the requirement that specifies the information must be located in the engine installation manual. These special conditions do not need to specify the document that must have the information, but only that the information must be provided to the installer in accordance with the engine installation instructions under § 33.5, “Instruction manual for installing and operating the engine.”. The proposed special conditions are modified to incorporate this change.

The FAA received a comment from UPSFF.

UPSFF requested that the FAA align these special conditions with the electric engine requirements included in the certification basis for special class powered lift aircraft that certify an electric engine as part of the aircraft type certification.

As stated previously, the engine requirements in the BETA special conditions are documented differently from proposed powered lift airworthiness criteria in draft AC 21.17-4 because special conditions are written in accordance with the requirements of § 21.16, and the proposed powered-lift airworthiness criteria in draft AC 21.17-4 are not specific to one applicant. Special conditions are project-specific rules of particular applicability, and the special conditions for this electric engine are based on certain novel or unusual design features. Special conditions may evolve to a general standard as more experience is gained with certifying the new technology (see Amdt. 21-51). No changes were made to these special conditions as a result of this comment.

The FAA received an anonymous comment. The commenter stated the reference to § 21.17(a) in the preamble of the NPSC seems contradictory to the language in § 21.17(b). The commenter explained that since § 21.17(b) applies to “special classes of aircraft, including the engines and propellers installed thereon ( e.g., gliders, airships, and other nonconventional aircraft) . . .” an electric engine would be installed on a special class of aircraft as described in § 21.17(b) and referring to § 21.17(a) seems to contradict the language in paragraph (b) of that section.

The FAA does not concur with the comment that indicates the reference to § 21.17(a) is contradictory to the language in § 21.17(b). Section 21.17(a) provides requirements for developing a certification basis for an established aviation product, which includes aircraft, engines, and propellers. The BETA electric engine is an aircraft engine, which falls under § 21.17(a), and therefore § 21.17(a) is the appropriate reference for this project. Section 21.17(b) provides requirements for developing a certification basis for special classes of aircraft, such as powered-lift. No changes were made as a result of this comment.

The FAA also determined that the following changes were necessary. The phrase, “In addition” is added to special condition no. 4, Fire protection, to connect the introduction sentence to (a) and (b) and avoid confusion. The FAA also revised the special conditions to use consistent references to hazardous engine effects. Therefore, the phrase “as defined in special condition no. 17 of these special conditions” was added wherever “hazardous engine effects” is mentioned.

The FAA recognizes energy regeneration might not be a feature for some electric engines that operate at their limits, so special condition no. 23 was changed to specify that “The endurance demonstration must include increases and decreases of the engine's power settings, energy regeneration, and dwellings at the power settings and energy regeneration for sufficient durations that produce the extreme physical conditions the engine experiences at rated performance levels, operational limits, and at any other conditions or power settings, including energy regeneration that are required to verify the limit capabilities of the engine.”

In addition, proposed special condition no. 31 was not adopted because the specific engine model BETA intends to certify is not designed to use a variable pitch propeller. Except as discussed above, these special conditions are adopted as proposed.

As discussed above, these special conditions are applicable to BETA Model H500A electric engines. Should BETA apply at a later date for a change to the type certificate to include another model on the same type certificate, incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

This action affects only BETA Model H500A electric engines. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for BETA Technologies Inc. Model H500A electric engines. The applicant must also comply with the certification procedures set forth in part 21.

(a) Unless otherwise noted in these special conditions, the engine design must comply with the airworthiness standards for aircraft engines set forth in part 33, except for those airworthiness standards that are specifically and explicitly applicable only to reciprocating and turbine aircraft engines or as specified herein.

(b) The applicant must comply with this part using a means of compliance, which may include consensus standards, accepted by the Administrator.

(c) The applicant requesting acceptance of a means of compliance must provide the means of compliance to the FAA in a form and manner acceptable to the Administrator.

In addition to § 33.7(a), the engine ratings and operating limits must be established and included in the type certificate data sheet based on:

(a) Shaft power, torque, rotational speed, and temperature for:

(1) Rated takeoff power;

(2) Rated maximum continuous power; and

(3) Rated maximum temporary power and associated time limit.

(b) Duty cycle and the rating at that duty cycle. The duty cycle must be declared in the engine type certificate data sheet.

(c) Cooling fluid grade or specification.

(d) Power-supply requirements.

(e) Any other ratings or limitations that are necessary for the safe operation of the engine.

The engine design must comply with § 33.15.

The engine design must comply with § 33.17(b) through (g). In addition—

(a) The design and construction of the engine and the materials used must minimize the probability of the occurrence and spread of fire during normal operation and failure conditions and must minimize the effect of such a fire.

(b) High-voltage electrical wiring interconnect systems must be protected against arc faults that can lead to hazardous engine effects as defined in special condition no. 17(d)(2) of these special conditions. Any non-protected electrical wiring interconnects must be analyzed to show that arc faults do not cause a hazardous engine effect.

The engine design and construction must minimize the development of an unsafe condition of the engine between maintenance intervals, overhaul periods, or mandatory actions described in the applicable ICA.

The engine design and construction must comply with § 33.21. In addition, if cooling is required to satisfy the safety analysis as described in special condition no. 17 of these special conditions, the cooling system monitoring features and usage must be documented and provided to the installer as part of the requirements in § 33.5.

The engine mounting attachments and related engine structures must comply with § 33.23.

The engine must comply with § 33.25.

(a) A rotor overspeed must not result in a burst, rotor growth, or damage that results in a hazardous engine effect, as defined in special condition no. 17(d)(2) of these special conditions. Compliance with this paragraph must be shown by test, validated analysis, or a combination of both. Applicable assumed rotor speeds must be declared and justified.

(b) Rotors must possess sufficient strength with a margin to burst above certified operating conditions and above failure conditions leading to rotor overspeed. The margin to burst must be shown by test, validated analysis, or a combination thereof.

(c) The engine must not exceed the rotor speed operational limitations that could affect rotor structural integrity.

(a) Applicability. The requirements of this special condition apply to any system or device that is part of the engine type design that controls, limits, monitors, or protects engine operation, and is necessary for the continued airworthiness of the engine.

(b) Engine control. The engine control system must ensure that the engine does not experience any unacceptable operating characteristics or exceed its operating limits, including in failure conditions where the fault or failure results in a change from one control mode to another, from one channel to another, or from the primary system to the back-up system, if applicable.

(c) Design Assurance. The software and complex electronic hardware, including programmable logic devices, must be—

(1) Designed and developed using a structured and systematic approach that provides a level of assurance for the logic commensurate with the hazard associated with the failure or malfunction of the systems in which the devices are located; and

(2) Substantiated by a verification methodology acceptable to the Administrator.

(d) Validation. All functional aspects of the control system must be substantiated by test, analysis, or a combination thereof, to show that the engine control system performs the intended functions throughout the declared operational envelope.

(e) Environmental Limits. Environmental limits that cannot be adequately substantiated by endurance demonstration, validated analysis, or a combination thereof must be demonstrated by the system and component tests in special condition no. 27 of these special conditions.

(f) Engine control system failures. The engine control system must—

(1) Have a maximum rate of loss of power control (LOPC) that is suitable for the intended aircraft application. The estimated LOPC rate must be documented and provided to the installer as part of the requirements in § 33.5;

(2) When in the full-up configuration, be single-fault tolerant, as determined by the Administrator, for electrical, electrically detectable, and electronic failures involving LOPC events;

(3) Not have any single failure that results in hazardous engine effects as defined in special condition no. 17(d)(2) of these special conditions; and

(4) Ensure failures or malfunctions that lead to local events in the aircraft do not result in hazardous engine effects, as defined in special condition no. 17(d)(2) of these special conditions, due to engine control system failures or malfunctions.

(g) System safety assessment. The applicant must perform a system safety assessment. This assessment must identify faults or failures that affect normal operation, together with the predicted frequency of occurrence of these faults or failures. The intended aircraft application must be taken into account to assure that the assessment of the engine control system safety is valid. The rates of hazardous and major faults must be documented and provided to the installer as part of the requirements in § 33.5.

(h) Protection systems. The engine control devices and systems' design and function, together with engine instruments, operating instructions, and maintenance instructions, must ensure that engine operating limits that can lead to a hazard will not be exceeded in service.

(i) Aircraft supplied data. Any single failure leading to loss, interruption, or corruption of aircraft-supplied data (other than power-command signals from the aircraft), or aircraft-supplied data shared between engine systems within a single engine or between fully independent engine systems, must—

(1) Not result in a hazardous engine effect, as defined in special condition no. 17(d)(2) of these special conditions, for any engine installed on the aircraft; and

(2) Be able to be detected and accommodated by the control system.

(j) Engine control system electrical power.

(1) The engine control system must be designed such that the loss, malfunction, or interruption of the control system electrical power source will not result in a hazardous engine effect, unacceptable transmission of erroneous data, or continued engine operation in the absence of the control function. Hazardous engine effects are defined in special condition no. 17(d)(2) of these special conditions. The engine control system must be capable of resuming normal operation when aircraft-supplied power returns to within the declared limits.

(2) The applicant must identify, document, and provide to the installer as part of the requirements in § 33.5, the characteristics of any electrical power supplied from the aircraft to the engine control system, including transient and steady-state voltage limits, and any other characteristics necessary for safe operation of the engine.

The applicant must comply with § 33.29(a), (e), and (g).

(a) In addition, as part of the system safety assessment of special condition nos. 10(g) and 33(h) of these special conditions, the applicant must assess the possibility and subsequent effect of incorrect fit of instruments, sensors, or connectors. Where practicable, the applicant must take design precautions to prevent incorrect configuration of the system.

(b) The applicant must provide instrumentation enabling the flight crew to monitor the functioning of the engine cooling system unless evidence shows that:

(1) Other existing instrumentation provides adequate warning of failure or impending failure;

(2) Failure of the cooling system would not lead to hazardous engine effects before detection; or

(3) The probability of failure of the cooling system is extremely remote.

(a) A mechanical and thermal stress analysis, as well as an analysis of the stress caused by electromagnetic forces, must show a sufficient design margin to prevent unacceptable operating characteristics and hazardous engine effects as defined in special condition no. 17(d)(2) of these special conditions.

(b) Maximum stresses in the engine must be determined by test, validated analysis, or a combination thereof, and must be shown not to exceed minimum material properties.

(a) The applicant must show, by a safety analysis or means acceptable to the Administrator, whether rotating or moving components, bearings, shafts, static parts, and non-redundant mount components should be classified, designed, manufactured, and managed throughout their service life as critical or life-limited parts.

(1) Critical part means a part that must meet prescribed integrity specifications to avoid its primary failure, which is likely to result in a hazardous engine effect as defined in special condition no. 17(d)(2) of these special conditions.

(2) Life-limited parts may include but are not limited to a rotor or major structural static part, the failure of which can result in a hazardous engine effect, as defined in special condition no. 17(d)(2) of these special conditions, due to a low-cycle fatigue (LCF) mechanism. A life limit is an operational limitation that specifies the maximum allowable number of flight cycles that a part can endure before the applicant must remove it from the engine.

(b) In establishing the integrity of each critical part or life-limited part, the applicant must provide to the Administrator the following three plans for approval:

(1) an engineering plan, as defined in § 33.70(a);

(2) a manufacturing plan, as defined in § 33.70(b); and

(3) a service-management plan, as defined in § 33.70(c).

(a) The lubrication system must be designed and constructed to function properly between scheduled maintenance intervals in all flight attitudes and atmospheric conditions in which the engine is expected to operate.

(b) The lubrication system must be designed to prevent contamination of the engine bearings and lubrication system components.

(c) The applicant must demonstrate by test, validated analysis, or a combination thereof, the unique lubrication attributes and functional capability of (a) and (b).

(a) The design and construction of the engine, including its control system, must enable an increase—

(1) From the minimum power setting to the highest rated power without detrimental engine effects;

(2) From the minimum obtainable power while in-flight and while on the ground to the highest rated power within a time interval determined to be appropriate for the intended aircraft application; and

(3) From the minimum torque to the highest rated torque without detrimental engine effects in the intended aircraft application.

(b) The results of (a)(1), (a)(2), and (a)(3) of this special condition must be documented and provided to the installer as part of the requirements in § 33.5.

If the design allows any of the engine main rotating systems to continue to rotate after the engine is shut down while in-flight, this continued rotation must not result in any hazardous engine effects, as defined in special condition no. 17(d)(2) of these special conditions.

(a) The applicant must comply with § 33.75(a)(1) and (a)(2) using the failure definitions in special condition no. 17(d) of these special conditions.

(b) The primary failure of certain single elements cannot be sensibly estimated in numerical terms. If the failure of such elements is likely to result in hazardous engine effects, then compliance may be shown by reliance on the prescribed integrity requirements of § 33.15 and special condition nos. 9 and 13 of these special conditions, as applicable. These instances must be stated in the safety analysis.

(c) The applicant must comply with § 33.75(d) and (e) using the failure definitions in special condition no. 17(d) of these special conditions, and the ICA in § 33.4.

(d) Unless otherwise approved by the Administrator, the following definitions apply to the engine effects when showing compliance with this condition:

(1) A minor engine effect does not prohibit the engine from performing its intended functions in a manner consistent with § 33.28(b)(1)(i), (b)(1)(iii), and (b)(1)(iv), and the engine complies with the operability requirements of special condition no. 15 and special condition no. 25 of these special conditions, as appropriate.

(2) The engine effects in § 33.75(g)(2) are hazardous engine effects with the addition of:

(i) Electrocution of the crew, passengers, operators, maintainers, or others; and

(ii) Blockage of cooling systems that could cause the engine effects described in § 33.75(g)(2) and special condition 17(d)(2)(i) of these special conditions.

(3) Any other engine effect is a major engine effect.

(e) The intended aircraft application must be taken into account when performing the safety analysis.

(f) The results of the safety analysis, and the assumptions about the aircraft application used in the safety analysis, must be documented and provided to the installer as part of the requirements in § 33.5.

(a) Rain, ice, and hail ingestion must not result in an abnormal operation such as shutdown, power loss, erratic operation, or power oscillations throughout the engine operating range.

(b) Ingestion from other likely sources (birds, induction system ice, foreign objects—ice slabs) must not result in hazardous engine effects defined by special condition no. 17(d)(2) of these special conditions, or unacceptable power loss.

(c) If the design of the engine relies on features, attachments, or systems that the installer may supply, for the prevention of unacceptable power loss or hazardous engine effects, as defined in special condition no. 17(d)(2) of these special conditions, following potential ingestion, then the features, attachments, or systems must be documented and provided to the installer as part of the requirements in § 33.5.

(a) Each system used for lubrication or cooling of engine components must be designed and constructed to function properly in all flight attitudes and atmospheric conditions in which the engine is expected to operate.

(b) If a system used for lubrication or cooling of engine components is not self-contained, the interfaces to that system must be defined, documented and provided to the installer as part of the requirements in § 33.5.

(c) The applicant must establish by test, validated analysis, or a combination of both that all static parts subject to significant pressure loads will not:

(1) Exhibit permanent distortion beyond serviceable limits, or exhibit leakage that could create a hazardous condition when subjected to normal and maximum working pressure with margin;

(2) Exhibit fracture or burst when subjected to the greater of maximum possible pressures with margin.

(d) Compliance with special condition no. 19(c) of these special conditions must take into account:

(1) The operating temperature of the part;

(2) Any other significant static loads in addition to pressure loads;

(3) Minimum properties representative of both the material and the processes used in the construction of the part; and

(4) Any adverse physical geometry conditions allowed by the type design, such as minimum material and minimum radii.

(e) Approved coolants and lubricants must be listed, documented, and provided to the installer as part of the requirements in § 33.5.

(a) The engine must be designed and constructed to function throughout its normal operating range of rotor speeds and engine output power, including defined exceedances, without inducing excessive stress in any of the engine parts because of vibration and without imparting excessive vibration forces to the aircraft structure.

(b) Each engine design must undergo a vibration survey to establish that the vibration characteristics of those components subject to induced vibration are acceptable throughout the declared flight envelope and engine operating range for the specific installation configuration. The possible sources of the induced vibration that the survey must assess are mechanical, aerodynamic, acoustical, internally induced electromagnetic, installation induced effects that can affect the engine vibration characteristics, and likely environmental effects. This survey must be shown by test, validated analysis, or a combination thereof.

When approval is sought for a transient maximum engine overtorque, the applicant must demonstrate by test, validated analysis, or a combination thereof, that the engine can continue operation after operating at the maximum engine overtorque condition without maintenance action. Upon conclusion of overtorque tests conducted to show compliance with this special condition, or any other tests that are conducted in combination with the overtorque test, each engine part or individual groups of components must meet the requirements of special condition no. 29 of these special conditions.

Each engine must be subjected to calibration tests to establish its power characteristics, and the conditions both before and after the endurance and durability demonstrations specified in special conditions nos. 23 and 26 of these special conditions.

The applicant must subject the engine to an endurance demonstration, acceptable to the Administrator, to demonstrate the engine's limit capabilities. The endurance demonstration must include increases and decreases of the engine's power settings, energy regeneration, and dwellings at the power settings and energy regeneration for sufficient durations that produce the extreme physical conditions the engine experiences at rated performance levels, operational limits, and at any other conditions or power settings, including energy regeneration that are required to verify the limit capabilities of the engine.

The engine design must demonstrate its capability to endure operation at its temperature limits plus an acceptable margin. The applicant must quantify and justify the margin to the Administrator. The demonstration must be repeated for all declared duty cycles and ratings, and operating environments, which would impact temperature limits.

The engine design must demonstrate safe operating characteristics, including but not limited to power cycling, starting, acceleration, and overspeeding throughout its declared flight envelope and operating range. The declared engine operational characteristics must account for installation loads and effects.

The engine must be subjected to a durability demonstration to show that each part of the engine has been designed and constructed to minimize any unsafe condition of the system between overhaul periods, or between engine replacement intervals if the overhaul is not defined. This test must simulate the conditions in which the engine is expected to operate in service, including typical start-stop cycles, to establish when the initial maintenance is required.

The applicant must show that systems and components that cannot be adequately substantiated in accordance with the endurance demonstration or other demonstrations will perform their intended functions in all declared environmental and operating conditions.

If shaft rotation is prevented by locking the rotor(s), the engine must demonstrate:

(a) Reliable rotor locking performance;

(b) Reliable rotor unlocking performance; and

(c) That no hazardous engine effects, as specified in special condition no. 17(d)(2) of these special conditions, will occur.

(a) Teardown evaluation.

(1) After the endurance and durability demonstrations have been completed, the engine must be completely disassembled. Each engine component and lubricant must be eligible for continued operation in accordance with the information submitted for showing compliance with § 33.4.

(2) Each engine component, having an adjustment setting and a functioning characteristic that can be established independent of installation on or in the engine, must retain each setting and functioning characteristic within the established and recorded limits at the beginning of the endurance and durability demonstrations.

(b) Non-Teardown evaluation. If a teardown cannot be performed for all engine components in a non-destructive manner, then the inspection or replacement intervals for these components and lubricants must be established based on the endurance and durability demonstrations and must be documented in the ICA in accordance with § 33.4.

The engine must be designed and constructed to protect against likely hazards from rotating components as follows—

(a) The design of the stator case surrounding rotating components must provide for the containment of the rotating components in the event of failure, unless the applicant shows that the margin to rotor burst precludes the possibility of a rotor burst.

(b) If the margin to burst shows that the stator case must have containment features in the event of failure, then the stator case must provide for the containment of the failed rotating components. The applicant must define by test, validated analysis, or a combination thereof, and document and provide to the installer as part of the requirements in § 33.5, the energy level, trajectory, and size of fragments released from damage caused by the main-rotor failure, and that pass forward or aft of the surrounding stator case.

(a) Maintenance of the engine may be made during the tests in accordance with the service and maintenance instructions submitted in compliance with § 33.4.

(b) The applicant must subject the engine or its parts to any additional tests that the Administrator finds necessary if—

(1) The frequency of engine service is excessive;

(2) The number of stops due to engine malfunction is excessive;

(3) Major engine repairs are needed; or

(4) Replacement of an engine part is found necessary during the tests, or due to the teardown inspection findings.

(c) Upon completion of all demonstrations and testing specified in these special conditions, the engine and its components must be—

(1) Within serviceable limits;

(2) Safe for continued operation; and

(3) Capable of operating at declared ratings while remaining within limits.

(a) Applicability. Any system or device that provides, uses, conditions, or distributes electrical power, and is part of the engine type design, must provide for the continued airworthiness of the engine, and must maintain electric engine ratings.

(b) Electrical systems. The electrical system must ensure the safe generation and transmission of power, and electrical load shedding if required, and that the engine does not experience any unacceptable operating characteristics or exceed its operating limits.

(c) Electrical power distribution.

(1) The engine electrical power distribution system must be designed to provide the safe transfer of electrical energy throughout the powerplant. The system must be designed to provide electrical power so that the loss, malfunction, or interruption of the electrical power source will not result in a hazardous engine effect, as defined in special condition no. 17(d)(2) of these special conditions.

(2) The system must be designed and maintained to withstand normal and abnormal conditions during all ground and flight operations.

(3) The system must provide mechanical or automatic means of isolating a faulted electrical energy generation or storage device from leading to hazardous engine effects, as defined in special condition no. 17(d)(2) of these special conditions, or detrimental effects in the intended aircraft application.

(d) Protection systems. The engine electrical system must be designed such that the loss, malfunction, interruption of the electrical power source, or power conditions that exceed design limits, will not result in a hazardous engine effect, as defined in special condition no. 17(d)(2) of these special conditions.

(e) Electrical power characteristics. The applicant must identify, declare, document, and provide to the installer as part of the requirements in § 33.5, the characteristics of any electrical power supplied from—

(1) the aircraft to the engine electrical system, for starting and operating the engine, including transient and steady-state voltage limits, and

(2) the engine to the aircraft via energy regeneration, and any other characteristics necessary for safe operation of the engine.

(f) Environmental limits. Environmental limits that cannot adequately be substantiated by endurance demonstration, validated analysis, or a combination thereof must be demonstrated by the system and component tests in special condition no. 27 of these special conditions.

(g) Electrical system failures. The engine electrical system must—

(1) Have a maximum rate of loss of power control (LOPC) that is suitable for the intended aircraft application;

(2) When in the full-up configuration, be single-fault tolerant, as determined by the Administrator, for electrical, electrically detectable, and electronic failures involving LOPC events;

(3) Not have any single failure that results in hazardous engine effects; and

(4) Ensure failures or malfunctions that lead to local events in the intended aircraft application do not result in hazardous engine effects, as defined in special condition no. 17(d)(2) of these special conditions, due to electrical system failures or malfunctions.

(h) System safety assessment. The applicant must perform a system safety assessment. This assessment must identify faults or failures that affect normal operation, together with the predicted frequency of occurrence of these faults or failures. The intended aircraft application must be taken into account to assure the assessment of the engine system safety is valid. The rates of hazardous and major faults must be declared, documented, and provided to the installer as part of the requirements in § 33.5.

I. Authority for This Rulemaking

The FAA's authority to issue rules on aviation safety is found in title 49 of the United States Code. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the FAA's authority.

This rulemaking is issued under the authority described in subtitle VII, part A, subpart III, section 44701(a)(5). Under that section, the FAA is charged with promoting safe flight of civil aircraft in air commerce by prescribing regulations and minimum standards for practices, methods, and procedures the Administrator finds necessary to ensure safety in air commerce. This regulation is within the scope of that authority. Amending the regulations for applications for operations specifications under part 129 submitted by foreign air carriers or foreign persons, and the related standards for denial of such an application for operations specifications authorizations, improves the FAA's ability to manage these authorizations. These operations specifications are issued to foreign air carriers operating within the United States and to foreign air carriers or foreign persons conducting operations of U.S.-registered aircraft solely outside the United States.

Prior to this action, FAA regulations required that foreign applicants for operations specifications must hold a valid air operator certificate (AOC) issued by the State of the Operator. See 14 CFR 129.7(c)(5). Requiring the operator to hold an AOC issued by the State of the Operator is consistent with the standard in Annex 6, Volume 1 to the Convention on International Civil Aviation, which directs that an operator shall not engage in commercial transport operations unless in possession of a valid AOC issued by the State of the Operator. 1

Some International Civil Aviation Organization (ICAO) Contracting States have joined together to form Regional Safety Oversight Organizations (RSOO). These organizations may provide a uniform regulatory structure for safety oversight and provide technical assistance and the execution of safety oversight functions for their member States. RSOOs have been established in many parts of the world. These organizations may be formed based on a variety of differing arrangements among member States. The institutional structures of these organizations range from highly formalized intergovernmental organizations established on the basis of formal legal agreements to less formalized organizations established under the ICAO Cooperative Development of Operational Safety and Continuing Airworthiness Program. 2

As stated in ICAO guidance, “under the Chicago Convention, only the State has responsibility for safety oversight, and this responsibility may not be transferred.”  3 The guidance further states that, although the State may delegate specific safety oversight tasks and functions to an RSOO, such as inspections for the certification of an operator, the State must still retain the minimum capability required to carry out its responsibilities under the Chicago Convention. States must always be able to properly and effectively monitor the safety oversight functions delegated to the RSOO. 4

States participating in RSOOs may delegate or transfer various functions or tasks to these organizations as stipulated in the RSOO's formation documentation. As provided in ICAO guidance, one of the functions member States may delegate or transfer to a highly formalized and more fully resourced RSOO is the issuance of AOCs for the State of the Operator. 5

In those instances where an AOC is issued by an RSOO rather than the member State, this regulation change now allows the FAA to review supporting documentation for applications for foreign air carrier operation specifications and, if acceptable to the Administrator, recognize as valid ( i.e., ensure that it conforms to ICAO standards) AOCs issued by an RSOO to foreign air carriers if the State of the Operator is a member State of that RSOO.

This rule amends the regulations for applications by foreign air carriers and foreign persons for operations specifications under 14 CFR part 129 and amends regulations for the denial of applications for operations specifications. This rule amends three sections in subpart A of part 129: § 129.1, Applicability and definitions; § 129.7, Application, issuance, or denial of operations specifications; and § 129.9, Contents of operations specifications. Based on the comments received in response to the notice of proposed rulemaking, the FAA has revised the rule language to clarify the requirements and remove any ambiguity regarding the intent of the amendments. See section III.C. of this preamble.

On May 22, 2024, the FAA published the notice of proposed rulemaking (NPRM) titled “Foreign Air Operator Certificates issued by a Regional Safety Oversight Organization” (89 FR 44935). The FAA also posted draft guidance material for the proposal, “FAA Order 8900.1, Volume 12, Chapter 2, Section 2,” for comment in the NPRM docket. The NPRM proposed to amend the regulations for applications by foreign air carriers and foreign persons for operations specifications under 14 CFR part 129 and the regulations for the denial of applications for operations specifications.

The FAA received four comments. 6 The agency received comments from one individual and three associations representing industry and labor constituencies. One of the associations supported the rule. Two of the associations opposed the rule, as discussed more fully in section IV. The FAA received comments on the proposal that addressed: support for the rule change; International Aviation Safety Assessments (IASA) for RSOOs; the number of IASAs needed; legal basis concerns; validation of Safety Management Systems (SMS) in IASAs for RSOO member States; and safety concerns.

In addition, on September 17, 2024, after the comment period closed, representatives of the Department of Transportation, Department of State, Department of Commerce, and Federal Aviation Administration met with representatives from Directorate-General Mobility and Transport (DG MOVE), European Aviation Safety Agency (EASA), and European Union (EU) Member States for a special meeting of the Joint Committee established by the U.S.—EU Air Transport Agreement. During the meeting, DG MOVE raised concerns with this rulemaking effort. A summary of the meeting has been posted to the docket for this rulemaking.

In the NPRM, the FAA proposed to establish new definitions in 14 CFR 129.1 for “Regional Safety Oversight Organization” and “State of the Operator.” As discussed more fully later in the preamble, the final rule revises the RSOO definition to clarify the relationship between a member State and an RSOO and the transfer of responsibilities between the entities to fully address the Air Line Pilots Association's (ALPA's) comment, which expressed concerns about a “legal fiction.” The FAA is finalizing the definition of “State of the Operator” as proposed.

As proposed in the NPRM, the FAA is amending § 129.7 to accommodate the recognition as valid by the FAA of AOCs issued by an RSOO on behalf of the State of the Operator. Based on the comments received, the FAA is revising § 129.7(c)(5) in the final rule to eliminate the term “on behalf of” to clarify the relationship between, and responsibilities of, the State of the Operator and an RSOO. This final rule also clarifies the FAA will accept an AOC only “ if acceptable to the Administrator,” whereas the NPRM limited this to the RSOO-issued AOCs and used the phrase “ as acceptable to the Administrator” (emphasis added). The final rule adds “if acceptable to the Administrator” to § 129.7(c)(5) and adds paragraphs (c)(5)(i) and (ii) to stipulate the FAA may accept an AOC issued by (i) the State of the Operator, or (ii) an RSOO if the State of the Operator is a member State of that RSOO.

In the NPRM, the FAA proposed an additional amendment to § 129.7(d) to align the conditions for the FAA's denial of an application for operations specifications with the conditions for eligibility for issuance of operations specifications. This amendment is adopted as proposed.

The FAA also proposed to amend § 129.9(a)(3) to reflect the possible acceptance and recognition as valid by the FAA of AOCs issued by an RSOO on behalf of the State of the Operator. The final rule simplifies the regulatory text in § 129.9(a)(3) and (b)(3) by removing the specification that an AOC may be issued by the State of the Operator or an RSOO. The FAA determined that the regulatory text in § 129.7(c)(5) establishes the basis for the FAA to accept a valid AOC, if acceptable to the Administrator, issued by (i) the State of the Operator; or (ii) an RSOO if the State of the Operator is a member State of that RSOO. Repeating this language in § 129.9 is unnecessary and redundant.

Section 369 of the FAA Reauthorization Act of 2024 amended chapter 447 of title 49 U.S.C. by adding section 44747, titled “Aviation safety oversight measures carried out by foreign countries.”  7 This amendment codified the FAA's IASA program. The IASA program is the means by which the FAA determines whether another country's oversight of its air carriers that (1) operate, or seek to operate, services to/from the United States using their own aircraft and crews, or (2) seek to display the code of a U.S. air carrier on any services, complies with safety standards established by ICAO. The published IASA results of a country's placement in Category 1 or Category 2 is the notification to the U.S. traveling public as to whether a foreign air carrier's State civil aviation authority (CAA) meets ICAO safety standards. A Category 1 rating indicates that the CAA meets ICAO safety standards for these operations, and a Category 2 rating indicates that the CAA does not meet ICAO safety standards.

On August 16, 2024, the FAA published a notice in the Federal Register (89 FR 66546) announcing the agency's suspension of policy changes to the IASA program that had been announced in a September 28, 2022, 8 Policy Statement, and a second notice in the Federal Register on the same day inviting public comments on proposed changes to the FAA IASA program policy (89 FR 66645). The comment period for the proposed policy closed on September 16, 2024, and the FAA is currently considering the comments received.

The National Business Aviation Association (NBAA) expressed support for the FAA's proposed changes to part 129 that would recognize AOCs issued by an RSOO. NBAA cited as an example the EASA, which has developed competency across a growing range of aviation capabilities, and with the further growth of mutual recognition of capabilities between FAA and EASA, the acceptance of certificates issued by EASA will greatly enhance process efficiency and approval consistency for European commercial operators seeking to access the United States. NBAA also stated that RSOOs meeting the requirements set forth in the proposed changes will benefit from this recognition along with commercial operators.

NBAA stated that as regulators seek to improve safety oversight efficiency and reduce process redundancies for operators and government agencies, efforts like this rulemaking will allow governments and industry to more efficiently deploy safety resources to operate in a global environment.

Allied Pilots Association (APA), while not supporting the rulemaking, acknowledged in its comment that it recognizes the vital importance of collaboration and cooperation when it comes to global aviation safety. As a result, APA indicated it understands the value that RSOOs can provide in promoting aviation safety oversight and stated APA's position on the proposed rule change should not be viewed as a criticism of RSOOs in general or the desire for ICAO member States to collaborate in the name of aviation safety.

The FAA acknowledges the support of the rulemaking expressed by NBAA and the overall support of RSOOs and their contribution to safety oversight expressed by APA.

ALPA commented the FAA must conduct a detailed inquiry of the level of participation of a State's CAA in the activities of the RSOO and all associated safety activities but stated the NPRM is unclear on whether the FAA would conduct an IASA of the RSOO itself.

ALPA stated it is unclear whether any RSOO is currently equipped with the correct process, procedure, personnel, and financial stability to serve in the role as a permanent regulatory oversight agency “on behalf of” the State of the Operator. ALPA believed the FAA should ensure that the regional oversight entity has sufficient “boots on the ground” (auditors and line inspectors with the right skillsets and training, funded by adequate resources, and backed by management with the requisite will to ensure compliance) to be fit for the purpose of satisfying each of those States' treaty obligations.

ALPA contended the FAA could determine all eleven of the ICAO-recognized RSOOs to be IASA Category 1, by default, which would generate unacceptable safety risks.

ALPA asserted the FAA must first complete an IASA for each RSOO before approving or renewing any new AOC from an RSOO. Then, once a specific AOC application is received by the FAA that invokes an RSOO/State AOC arrangement, ALPA believed the FAA should conduct a separate IASA review of the RSOO/State plan for AOC oversight of the air carriers applying to operate under part 129.

Although APA did not specifically suggest the FAA conduct IASAs on RSOOs, APA stated that due to the varying levels of formality in structure among the currently existing RSOOs, each AOC issued by an RSOO would have to be reviewed and analyzed for validity and appropriateness before being recognized by the Administrator. APA asserted this would require the Administrator to review and understand the approval and issuance process of each RSOO to be able to determine if the applicant's operator certificate should be recognized as valid. As a result, APA believed the proposal makes the application review process more cumbersome and complex.

The FAA generally disagrees with the concern expressed by APA about this rule change, adding complexity and additional burden to the FAA's IASA program. However, the FAA agrees with APA that each AOC issued by an RSOO must be reviewed for validity before being recognized by the Administrator.

The responsibility for ensuring compliance with international standards established under the Chicago Convention falls to the member States as parties to the Convention. As such, the FAA IASA program assesses the CAA for the State of the Operator. Specifically, the IASA program assesses and determines the State of the Operator's compliance with the standards in ICAO Annex 1 (Personnel Licensing), Annex 6—Part 1 and Part 3 (Operation of Aircraft), and Annex 8 (Airworthiness of Aircraft). The FAA reviews the CAA's compliance by assessing ICAO's eight critical elements of effective aviation safety oversight in the ICAO Document 9734, Safety Oversight Manual. Those eight critical elements include:

When a CAA, as a member of an RSOO, transfers a task or function to the RSOO, the FAA expects the transfer to be documented in an agreement, treaty, or informal written record of the parties' understanding that is available for review by the Administrator. 9 This includes filings with ICAO outlining the arrangement between the RSOO and its member States.

While the State of the Operator may transfer responsibility for certain tasks and functions to an RSOO, it cannot transfer its responsibility under the Chicago Convention. The FAA will continue to assess the State of the Operator as the responsible party for compliance with the ICAO standards. This assessment will ensure the State maintains the responsibility for the issuance and continued oversight of the AOC by the RSOO. When the State transfers the function of issuance of an AOC to an RSOO, the transfer documentation established by the State and the RSOO will be used by the FAA to determine which organization has responsibility for each task and function associated with issuance of an AOC. The FAA will use existing IASA procedures to assess the State to ensure the correct process, procedure, personnel, and financial stability necessary to accomplish transferred tasks or functions meet ICAO standards. The FAA does not believe the nuance of determining if the transferred task or functions is accomplished by the RSOO or retained by the State of the Operator adds a significant level of complexity to the process.

As such, the FAA does not anticipate an IASA on an RSOO will be required to determine whether the CAA complies with the ICAO standards. For AOCs issued by the RSOO, however, the FAA will review the formation documentation for each RSOO and each RSOO-issued AOC for validity and consistency with ICAO standards. In the case of AOC issuance, the specific requirements that must be validated are only a small subset of ICAO standards. In most cases, the FAA expects that RSOO-issued AOCs will have been issued for States that have been assessed by the FAA, already resulting in an IASA Category 1 rating. Therefore, with the transfer of functions and duties to an RSOO, the FAA would conduct a more focused evaluation of the specific requirements associated with AOC issuance for the country in question. As a party to the Chicago Convention, the State remains the accountable organization to be assessed by the FAA under an IASA, and the RSOO is expected to participate in the IASA assessment as an observer for transferred functions.

For all RSOO member States that have not had an IASA conducted by the FAA previously, an assessment of compliance with the ICAO standards for issuance of an AOC (including any functions or tasks transferred to an RSOO) will be done as part of the initial IASA for that State. An initial IASA of the State of the Operator must be completed before the FAA may accept an RSOO-issued AOC for that State. The RSOO may observe and support the State during the IASA to provide information about the RSOO's roles and responsibilities for the tasks and functions as transferred by the State.

ALPA stated that the FAA has incorrectly assumed that it will not need to increase the number of IASA assessments. ALPA contended the FAA will need to assess each RSOO at issue, which has never been assessed before. ALPA stated the FAA will need to conduct specific reviews of the national CAAs to which an RSOO may delegate certain functions. ALPA was concerned that if more assessments are needed, the FAA “will simply subtract one” from its average number of five IASAs typically completed per year. ALPA contended that doing fewer assessments, not more, does not represent an equivalent level of safety and that a foreign entity's desire for an assessment must not overwhelm the FAA's obligation to determine what is in the U.S. public interest.

The FAA understands ALPA's concern but does not expect the number of IASA assessments to increase in the near term, given the FAA is aware of only one RSOO issuing AOCs for member States, to date. The FAA also does not expect a decrease in the number of IASAs conducted on average, historically.

As indicated previously, the FAA will continue to conduct IASAs for States that seek to initiate service to the United States, or for those States that have been identified as requiring a reassessment based on risk factors, whether the operator's AOC is issued by the State of the Operator or an RSOO. During an initial IASA evaluation of the State, the transferred functions will be assessed by the FAA to determine compliance with ICAO standards.

If a State previously assessed by the FAA as IASA Category 1 subsequently transfers the function of AOC issuance to an RSOO, the FAA's regulatory process for AOC validation includes ensuring the ICAO standards and eight critical elements for those standards are still being met for that specific function without conducting a full IASA. If the FAA's evaluation of the transferred function cannot establish ICAO compliance using the established validation process, the AOC will not be accepted by the FAA. The FAA does not anticipate conducting a complete IASA reassessment solely based on transfer of the function of issuance of an AOC to an RSOO. The lack of confirmation of compliance with ICAO AOC standards due to the transfer of the function to an RSOO would, however, be included as a risk consideration when the FAA is reviewing a State for IASA reassessment.

The FAA uses a risk analysis process to identify IASA Category 1 countries for reassessment. The risk analysis is performed at least annually and whenever new safety information is obtained on each country on the IASA Category Rating list to determine countries of highest risk to the U.S. National Airspace System (NAS) and the U.S. traveling public. The risk analysis was developed by FAA experts and is comprised of individual risk elements and grouped into the following five major IASA risk categories:

(1) Department of Transportation Economic Authority—New or existing U.S. DOT economic authority; own-metal U.S. service under part 129; new or current codeshare involving display of U.S. air carrier code on foreign operator flights; and any U.S. DOT administrative emphasis items and initiatives.

(2) Governance and Safety Culture—Areas of interest include: contracting of safety oversight functions; carrier wet lease to airlines of other countries; safety items identified by the CAA remain unresolved or not addressed; complaints received by FAA from other CAAs, operators, manufacturers, and the traveling public.

(3) IASA Information—Time passed since the last IASA, and other factors that indicate the Category 1 rating may no longer be valid.

(4) ICAO Requirements—Risk concerns include: negative ICAO Universal Safety Oversight Audit Program (USOAP) findings indicating noncompliance with one or more of the eight critical elements of safety oversight; ICAO reports indicating noncompliance with Standards and Recommended Practices (SARPs); inaction with respect to ICAO action plans; ICAO USOAP information over two years old thus limiting its value.

(5) FAA Information—FAA has safety concerns about the oversight provided by the CAA, which include the areas of: FAA and foreign ramp inspections; safety-related complaints about carrier(s) from other CAAs; active technical assistance activities; compliance issues are present in FAA certificated or approved entities in the country; Congressional inquiries; and existing bilateral agreement implementation procedures.

The risk associated with the FAA's inability to validate ICAO compliance due to a transfer of tasks or functions would be included in the ICAO requirements category of risks.

The FAA mitigates identified State safety oversight risks by placing all carriers from that State, authorized to operate to the United States, under heightened surveillance until the IASA reassessment is completed. 10 In extreme cases where safety or oversight risks cannot be mitigated, the FAA has regulatory authority to remove the authorization from any or all carriers authorized to operate from that State. 11

ALPA and APA expressed concerns about the legal basis and compliance with ICAO standards associated with the proposed rulemaking. ALPA stated the proposal seems contradictory. ALPA commented that on one hand, the FAA's proposal seeks to overcome the Chicago Convention's clear instruction by stating that the regional oversight entity would be acting “on behalf of” a State and thus would purportedly comply with the treaty. ALPA contended that as a result, the proposal would hold the State to account, even though the State would designate the regional entity as the responsible authority. ALPA stated, on the other hand, the proposal recognizes the regional entity would be responsible, and U.S. recognition of operating licenses would be at odds with U.S. obligations under the treaty, such that a “difference” would have to be filed by the United States with ICAO.

ALPA asserted the FAA's regulatory language “on behalf of,” as in “on behalf of the State of the Operator,” introduces ambiguity because the entity doing the acting (on behalf of) is the one with actual responsibility. ALPA commented that this “legal fiction is to be a workaround from what ICAO admits being the role of the RSOO . . .”

ALPA commented that the Chicago Convention recognizes the value in a clear line of responsibility from a national government authority to an air carrier and that only States are deemed the valid issuers of such a license, in accordance with ICAO Guidance on RSOOs. 12 ALPA had significant concerns about how an RSOO's relationship with the State of the Operator will work in practice, including a concern that an RSOO often delegates responsibilities for AOC oversight back to the State of the Operator. ALPA urged the FAA to deem the RSOO, not the State of the Operator, to be “ultimately responsible for the IASA” assessment.

For an existing IASA Category 1 State, the FAA's assessment has already established the State complies with ICAO standards for the issuance of an AOC. The FAA Order 8900.1, volume 12, chapter 2, section 2 procedure for the evaluation of AOC issuance and subsequent transfer of the tasks and functions then focuses on ensuring all the required tasks and functions for AOC oversight are addressed, and the responsibility for each of those tasks or functions is clearly defined. The FAA procedure also ensures that there is evidence in the transfer documentation that covers the roles and responsibilities necessary for the continued compliance of the AOC holder with the ICAO AOC standards during the life cycle of the AOC. If the FAA cannot determine compliance, the AOC will not be accepted by the FAA until compliance with the required ICAO standards can be confirmed by the FAA.

To the extent that ALPA suggests that, to act in compliance with the Chicago Convention, an AOC may only be issued by the State of the Operator, the FAA disagrees. The Chicago Convention does not speak directly to the issuance of AOCs. Rather, there is a standard in Annex 6, Volume 1 that prohibits an operator from engaging in commercial air transport operations unless the operator possesses a valid AOC issued by the State of the Operator. While a member State must comply with its obligations under the Chicago Convention, Article 38 allows a State to file a difference with ICAO to acknowledge differences between the State's own practices and those standards established in the Annexes to the Convention. Consistent with the obligation to provide notice of a difference, the FAA will file a difference to 4.2.1.1 of Annex 6, Volume 1, acknowledging the FAA's acceptance of RSOO-issued AOCs when the Administrator determines they are acceptable ( i.e., issued in conformance with ICAO standards for AOCs).

To the extent the commenters suggest the characterization that an RSOO issues AOCs “on behalf of” a member state is in conflict with the FAA's determination that a difference must be filed, the FAA finds that the two concepts are not irreconcilable. However, the FAA has determined that certain clarifying changes, identified in the following discussion, should be made to the regulatory text in this final rule.

ICAO acknowledges in its guidance that existing RSOOs have taken a variety of forms, ranging from a relatively loose association of CAAs that have agreed to cooperate in the development and implementation of requirements and procedures, to an intergovernmental organization with regulatory and, to some extent, enforcement authority. According to ICAO, the form that an RSOO takes will primarily be determined by the needs of its members, the level of available resources, the scope of activities, the level of authority delegated by member States, and, in certain cases, the legislative framework already established by the group or community of States creating the RSOO. 13

Given the varying frameworks that RSOOs may take, the FAA agrees that it is critical for States to maintain and demonstrate clear lines of responsibility  14 in order for the FAA to properly assess the acceptability of an AOC issued by an RSOO in place of the State of the Operator. The final rule enables FAA review of the RSOO and State of the Operator formation documentation to ensure the transferred tasks and functions associated with the issuance and continued surveillance of the AOC holder are clearly defined and that the ICAO standards for assessing the AOC applicant have been met. See definition of RSOO in § 129.1 of the final rule. This final rule further ensures the FAA review of all ICAO Standards related to AOC issuance that are assessed during an IASA.

The transferred function affected by this rulemaking, which the FAA has determined would necessitate filing a difference from ICAO standards, is limited to the transfer of responsibility for issuing the AOC from a member State to an RSOO. However, the FAA recognizes there could be significant variability between the responsibilities of RSOOs and which AOC issuance functions are transferred to them by member States. When a CAA transfers functions related to AOC issuance or the conduct of oversight-related tasks in conjunction with AOC issuance to an RSOO, the State of the Operator is still responsible for ensuring that the transferred functions continue to comply with ICAO standards. Therefore, the FAA disagrees with ALPA's assertion the FAA should hold the RSOO ultimately responsible for the IASA.

Nevertheless, the FAA agrees with ALPA that the language “on behalf of” included in the NPRM introduces unnecessary ambiguity and an apparent, though unintended, conflict with the FAA's position that a difference must be filed with ICAO as a result of this rulemaking.

Therefore, the FAA revised the text of the final rule in § 129.7 to remove this qualifier. This final rule also clarifies the FAA will only accept an AOC issued by the State of the Operator or an RSOO “ if acceptable to the Administrator” (emphasis added). In addition, the FAA is making corresponding changes to the definition of RSOO in § 129.1 to reflect that authority may either be formally delegated between the member States and the RSOO or tasks and functions may be less formally transferred or assigned. The changes to §§ 129.1 and 129.7 are otherwise adopted as proposed.

As for the concerns about transfer of tasks and functions related to the issuance of an AOC from the State of the Operator to the RSOO and subsequent transfer of oversight-related tasks or functions pertaining to AOC issuance back to the State of the Operator, the FAA agrees these roles and responsibilities must be clearly defined, documented, and understood. The final rule ensures the FAA must review the documented transfer of all tasks and functions related to the issuance of an AOC from the State of the Operator to the RSOO.

Consistent with the FAA's proposal for accepting an AOC from an RSOO, the RSOO must meet the FAA's definition of RSOO in 14 CFR 129.1, which, as updated for this final rule, is an association or organization that comprises a group of member States, which—(i) Has provided notification to ICAO of the scope of tasks and functions delegated or transferred to the RSOO, including but not limited to: sharing common or harmonized aviation regulations, licensing, certification, authorization, approval, and surveillance of civil aviation activities, and any legal authority delegated or transferred by a member State to the RSOO; and (ii) Has stipulated the specific tasks, functions, delegations, and transfers by member States discussed in paragraph (c)(2)(i) of § 129.1, and any other collective understandings of member States in RSOO formation documentation, such as an agreement, treaty, or informal record, that is available for review by the Administrator.

The FAA will verify that each task or function required by ICAO Annex 6 standards is included in the transfer and formation documentation and the organizational responsibility for each is clearly defined. Consistent with the definition of RSOO, the RSOO formation documentation should outline not only the roles and responsibilities for tasks and functions necessary for the issuance of the AOC but also for the tasks and functions for continued oversight of the AOC during its full life cycle, for the FAA to fully evaluate an RSOO-issued AOC. The FAA acknowledges that there may be a transfer of tasks and functions back to the State of the Operator. This is not an unusual practice and could be a result of the RSOO leveraging the member State's availability of trained and qualified personnel needed for the evaluation of the carrier for initial certification.

The FAA uses a similar practice for certification of United States part 121 air carriers. The part 121 certification process is a cooperative effort between the Certification and Evaluation Program Office (CEPO) of the Safety Analysis and Promotion Division and the Office of Air Carrier Safety Assurance (ACSA). The CEPO is a dedicated group of aviation safety inspectors (ASIs) with experience in the details and nuances of initial Air Carrier certification. The CEPO assigns an assistant manager as the Certification Front Line Manager (CFLM) and a qualified CEPO team leader as the certification project manager (CPM). The CEPO initiates the certification and directs the project through all phases of the certification process. The ACSA assigns the certificate management office (CMO) and establishes a Certificate Management Team (CMT) to perform Continued Operational Safety (COS) oversight after certification. The Certification Project Team (CPT) will include ASIs from the CEPO and the ACSA. These dedicated inspectors then turn the continued surveillance of the operator to the CMO to perform the oversight functions for the carrier. This is done to ensure standardization of air carrier certification.

Transfer of tasks or functions from the State of the Operator to an RSOO may provide a similar benefit of targeting resources with detailed experience in the initial certification of air carrier, working in concert with those responsible for continued oversight of the air carrier.

ALPA recommended the FAA take the opportunity to expand its own IASA program by ensuring the novel regional safety organization requires its licensees to fully comply with SMS, a critical element that ICAO has implemented to address a root cause of accidents and incidents. ALPA asserted the FAA has the discretionary power, as well as an obligation to flight crews, the traveling public, and the international community, to evaluate RSOO member State implementation of SMS. Moreover, ALPA noted one such RSOO, EASA, appears headed toward conducting such SMS audits, which ALPA stated is a welcome development.

The FAA's current IASA program includes evaluation of a State's aviation oversight program for compliance with ICAO Annex 1, Annex 6, and Annex 8. Neither the current IASA Notice of Policy Statement  15 nor section 369 of the FAA Reauthorization Act of 2024 codifying the IASA program in 49 U.S.C. 44747 include Annex 19 Safety Management requirements for this program. The inclusion of these requirements was not contemplated in the NPRM and is therefore beyond the scope of this rulemaking.

ALPA contended the proposed rule would create significant safety concerns that were not addressed in the NPRM. Specifically, ALPA contended an RSOO that has aircraft certification oversight, and oversees AOCs, could determine that when using certain aircraft certified by the RSOO, airline flights could be conducted with only a single pilot on the flight deck while the second pilot is resting or otherwise unavailable to serve as the second pilot. ALPA commented that the RSOO's certification and AOC approval combined would potentially allow a significant safety threat to occur in airspace managed by the United States, unraveling many of the advances in airline safety that have been achieved in the United States. ALPA urged the FAA to be extremely vigilant and consider unintended safety consequences of allowing RSOOs to simultaneously operate as an aircraft certification organization and AOC oversight organization.

APA stated that delegating the authority to determine whether a carrier or person has satisfied those standards to a regional organization, which may have competing political or industrial influences, allows for the possibility the standards will be unintentionally deteriorated or altered. To eliminate the possibility for such deterioration or alteration, the FAA should not amend the current regulations to allow the acceptance of an RSOO-issued operator certificate in lieu of one issued directly by the State of the Operator.

Finally, APA contended even where a member State has elected to delegate the authority to issue operator certificates to an RSOO, the member State must still retain the ability to issue operator certificates on its own. Accordingly, maintaining the regulatory status quo would not adversely impact a foreign applicant's ability to obtain operating specifications from the FAA because they remain able to obtain an operator certificate issued by the State of the Operator.

The FAA understands this concern but disagrees with the premise that the role of an RSOO in the issuance of an AOC alone, as promulgated in this rulemaking, could introduce risks such as foreign air carrier single pilot operations in the United States. The cited concern would not be the result of this rulemaking allowing the FAA to accept an RSOO-issued AOC. This could similarly be an issue for AOCs issued by the State of the Operator should that State apply a risk-based approach allowing one pilot to fly while the other rests. In either case, foreign air carriers approved for operations into the United States must still comply with all applicable FAA rules and regulations, including the conditions and limitations set forth in their operations specifications. The FAA notes that, to date, no part 121 or 129 air carriers have been authorized by the FAA to operate with a single pilot at the controls.

While not directly subject of this rulemaking, the FAA will consider the risk of single pilot operations identified by ALPA for all foreign AOC applicants and adjust our policy as required to ensure these risks are properly mitigated or prohibited during our evaluation of the proposed operation to ensure the operator is properly and adequately equipped to conduct the operations described in the operations specifications.

The FAA notes ICAO Annex 6, Part 1, paragraph 9.1.1 addresses composition of flight crews. It states:

The number of crew required not only drives the type certification requirements listed in the operations manual but also the type of operation. This standard allows the FAA to ensure the risks of any operation have been identified, assessed, and properly mitigated.

The FAA agrees the State of the Operator is responsible for establishing requirements for issuing AOCs that are compliant with the ICAO standards. The FAA's IASA program validates the State's compliance with these ICAO standards. When the tasks or functions related to AOC issuance or oversight activities pertaining to AOC issuance are transferred to an RSOO, the State of the Operator is still responsible for ensuring the transferred functions continue to comply with ICAO standards even if the State of the Operator did not issue the AOC. This remains true whether States transfer all or part of the AOC issuance tasks or functions for a specific carrier or retain the ability to issue other AOCs in their State.

The FAA also agrees that vigilance is needed when issuing part 129 operation specifications. As such, there are additional regulatory requirements, and a valid AOC is only one part of the requirements for issuing a foreign operator a part 129 authorization. Section 129.7(c) lists all the requirements for issuance of operations specifications for authorization to conduct service to the United States.

Introduction of risks when authorizing part 129 operations is addressed through the evaluation of the carrier to ensure they are properly and adequately equipped to conduct the operations described in the operations specifications and are in compliance with the requirements of part 129. Also, 14 CFR 129.5(b) states “Each foreign air carrier conducting operations within the United States must conduct its operations in accordance with the Standards contained in Annex 1 (Personnel Licensing), Annex 6 (Operation of Aircraft), Part I (International Commercial Air Transport—Aeroplanes) or Part III (International Operations—Helicopters), as appropriate, and in Annex 8 (Airworthiness of Aircraft) to the Convention on International Civil Aviation.”

These steps ensure all foreign commercial operations are properly assessed, and any associated risks are appropriately mitigated. This is true not only for carriers issued AOCs by RSOO but all carriers requesting authorization to operate to the United States.

The FAA intends to file a difference with ICAO because the acceptance of RSOO-issued AOCs reflects a departure from the international standard in ICAO Annex 6, paragraph 4.2.1.1 to the extent the means of compliance in this final rule is different from the corresponding standard in Annex 6. However, the FAA's assessment of the formation documentation between the member State and RSOO to validate the ICAO standards for issuing an AOC have been met will ensure an equivalent level of safety.

As previously noted, the FAA proposed to amend § 129.9(a)(3) to reflect the possible acceptance and recognition as valid by the FAA of AOCs issued by an RSOO on behalf of the State of the Operator. In this final rule, the FAA has revised the regulatory text proposed for 14 CFR 129.9(a)(3) and (b)(3) by removing the reference that an AOC may be issued by the State of the Operator or an RSOO. This language is unnecessary in this context since the application requirements in 14 CFR 129.7(c)(5) specify the issuing entities from which the FAA may accept AOCs. Removal of this duplicative language is a technical amendment and not a substantive change.

The FAA determined to apply a 30-day effective date to this final rule. Therefore, this final rule will take effect 30 days after publication in the Federal Register . The FAA generally applies a longer effective date to final rules to allow time for the impacted regulated community to prepare to come into compliance with the requirements of a final rule. However, this final rule is considered to be enabling to the extent the FAA is expanding the options for AOC acceptance by the FAA for purposes of applications for part 129 operations specifications. The FAA expects the effective date of this final rule to benefit the impacted community of operators seeking to apply for part 129 operations specifications based on an RSOO-issued AOC by allowing for the earlier submission of an application. The FAA notes that no such applications are currently considered pending before the FAA. Once this final rule takes effect, operators may submit an application to the FAA consistent with revised 14 CFR 129.7, and the FAA will be prepared to begin the review process. During this process, the FAA will ascertain if sufficient information has been provided to validate continued compliance with the required ICAO standards or if an IASA of the State will be required before the AOC can be considered acceptable to the Administrator. The FAA further notes that consistent with § 129.7(a)(2), the application must be submitted to the FAA at least 90 days before the intended date of operation.

Federal agencies consider the impacts of regulatory actions under a variety of executive orders and other requirements. First, Executive Orders 12866, 13563, and 14094 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify the costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. The current threshold after adjustment for inflation is $183,000,000 using the most current (2023) Implicit Price Deflator for the Gross Domestic Product.

In conducting these analyses, the FAA has determined that this rule: will result in benefits that justify costs; is not significant under section 3(f)(1) of Executive Order 12866, as amended; will not have a significant economic impact on a substantial number of small entities; will not create unnecessary obstacles to the foreign commerce of the United States; and will not impose an unfunded mandate on State, local, or Tribal governments, or on the private sector.

This rule will allow for the FAA's acceptance of AOCs issued by RSOOs, and it will update the regulatory basis for denial of applications for operations specifications. There are no changes to the analysis of this final rule as it was presented in the proposed rule.

Prior to this action, a foreign air carrier applying for operations within the United States or applying to operate U.S.-registered aircraft solely outside of the United States must hold a valid AOC issued by the State of the Operator. The existing regulations do not provide for acceptance of an AOC issued by any other entity other than the State of the Operator. This final rule will allow the FAA to recognize AOCs issued by an RSOO if the State of the Operator is a member State of that RSOO. This allows foreign air carriers with a valid AOC issued by an RSOO, if acceptable to the Administrator, to be issued authorization to operate to and from the United States, providing travel services to citizens of the United States and the foreign countries, economic opportunities for U.S. airlines through code share agreements with these operators, and expanded route structures for these code share partners. This final rule is consistent with ICAO resolutions and guidance, which address the development and use of RSOOs.

Under current practice for operations within the United States, before acceptance of the AOC, the FAA conducts an IASA of the State of the Operator. 16 These assessments involve pre-work and document review in the United States lasting several weeks, followed by an on-site assessment in the State of the Operator lasting five business days. When the State of the Operator is a member of an RSOO, and that State has delegated functions or tasks to the RSOO, this prework would include a review of functions or tasks that are delegated by the State to an RSOO, the scope and level of those delegations, and the need for RSOO participation in assessing the State's compliance with the ICAO standards. The assessments involve two to four inspectors and an attorney. An FAA IASA team incurs traveling costs, such as airfare, lodging, and per diem associated with the travel destination. However, these assessments, including the prework, are not expected to represent an additional cost of the rule because the FAA currently conducts them, and the FAA does not expect any increase in the number of assessments as a result of this rulemaking. Currently, when accomplishing an IASA on a State that has delegated functions or tasks to an RSOO, the FAA reviews that delegation to ensure that the State's and the RSOO's functions and tasks are in compliance with the ICAO requirements. Historically, the FAA has conducted, on average, five IASAs each year. As stated previously, there are many factors that determine the number of IASAs that will be accomplished in any given year. These include application for own metal service to the United States by a carrier from a State that has not been assessed where a risk assessment has identified concerns over the State's safety oversight functions which warrant a reassessment. Any risks identified in the course of the FAA's review of an RSOO-issued AOC for acceptance will be included as one factor in the risk assessment for the respective member State.

If the FAA has previously assessed a State of the Operator and that State subsequently delegated functions or tasks, such as issuance of AOCs by the RSOO, the FAA will review the RSOO formation documentation to determine if further assessment to evaluate the continued compliance with ICAO standards is required. If the FAA determines it needs to do further assessment, the State of the Operator's compliance with ICAO standards for issuance of AOCs will be reviewed as part of the annual risk assessment for all IASA-categorized States. Based on the result of the risk assessment, an IASA of that State may be accomplished as one of that year's or future year's IASAs. The FAA does not anticipate requiring an IASA reassessment based solely on the inability to determine compliance with ICAO standards for the transferred function of AOC issuance and the conduct of oversight-related tasks pertaining to AOC issuance between an RSOO and member States. The FAA has many means to reach out to the RSOO and the member State to obtain information concerning questions on compliance. This can involve sending letters for clarification and direct discussions to clarify issues. However, until the State's ICAO compliance can be validated, the RSOO-issued AOC of the operator will not be considered acceptable, and no authorization will be granted.

The FAA is also amending the conditions under which the FAA can deny the application for operations specifications in subpart A of part 129. Prior to this action, § 129.7(c) specifies that an applicant must meet five conditions to be issued operations specifications. These conditions require that the applicant meets the applicable requirements of part 129; holds the economic or exemption authority required by the Department of Transportation, applicable to the operations to be conducted; complies with the applicable security requirements of 49 CFR chapter XII; is properly and adequately equipped to conduct the operations described in the operations specifications; and holds a valid AOC issued by the State of the Operator. However, § 129.7(d) states that the application may be denied if the applicant is not properly and adequately equipped to conduct the operations described in the operations specifications. The change will expand the basis for denial to any of the five conditions listed in § 129.7(c). The updates to the regulatory basis for denial of applications for operations specifications will not result in any costs. The change will align the basis for denial of an application to the conditions that must be met for issuance of operations specifications. This will allow the FAA to formally deny applications that do not meet the requirements of § 129.7(c) instead of the FAA's current practice of holding the approval of ineligible applications in abeyance until the conditions are met or the applicant withdraws the application. There are no specific costs associated with holding an application in abeyance. The benefit of allowing denial of an application based on not meeting the regulatory criteria is reduction of applications in process and ensuring currency of information provided with an application.

The Regulatory Flexibility Act (RFA) of 1980, Public Law 96-354, 94 Stat. 1164 (5 U.S.C. 601-612), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121, 110 Stat. 857, Mar. 29, 1996) and the Small Business Jobs Act of 2010 (Pub. L. 111-240, 124 Stat. 2504, Sept. 27, 2010), requires Federal agencies to consider the effects of the regulatory action on small business and other small entities and to minimize any significant economic impact. 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.

This final rule will update the regulations for applications by foreign air carriers and foreign persons for operations specifications under part 129. The final rule will apply to foreign air carrier operations within the United States and to U.S.-registered aircraft in common carriage solely outside the United States. Since this final rule only impacts foreign applicants, this rule has no impact on U.S. small entities. If an agency determines that a rulemaking will not result in a significant economic impact on a substantial number of small entities, the head of the agency may so certify under section 605(b) of the RFA. Therefore, as provided in section 605(b) and based on the foregoing, the head of FAA certifies that this rulemaking will not result in a significant economic impact on a substantial number of small entities.

The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards.

The FAA has assessed the potential effect of this final rule and determined that it ensures the safety of the American public by allowing the acceptance of AOCs issued by an RSOO when reviewed and found acceptable to the Administrator. While this action will result in the United States' filing a difference with ICAO regarding compliance with ICAO Annex 6, paragraph 4.2.1.1, this rule change results in an equivalent action to the standard and is in the public's interest. As a result, the FAA does not consider this rule as creating an unnecessary obstacle to foreign commerce.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or Tribal government or the private sector to incur direct costs without the Federal Government having first provided the funds to pay those costs. The FAA determined that the final rule will not result in the expenditure of $183,000,000 or more by State, local, or Tribal governments, in the aggregate, or the private sector, in any one year.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. According to the 1995 amendments to the Paperwork Reduction Act (5 CFR 1320.8(b)(2)(vi)), an agency may not collect or sponsor the collection of information, nor may it impose an information collection requirement unless it displays a currently valid Office of Management and Budget (OMB) control number.

The FAA has determined that there is no new information collection associated with the requirement for application for foreign air carrier authorization under 14 CFR part 129. In order to apply for operation specifications, the applicant is required to provide a copy of their AOC to the FAA. Under the final rule, the FAA intends to rely on cooperation of RSOOs to obtain the necessary formation documentation referred to in the § 129.1 definition of RSOO. No new information is required from the applicant operator if the AOC is issued by an RSOO. The burden of validation of the AOC remains with the FAA in conjunction with the State of the Operator. Approval to collect such information previously was approved by OMB under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) and was assigned OMB Control Number 2120-0749.

In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to conform to ICAO Standards and Recommended Practices to the maximum extent practicable.

The FAA has reviewed the corresponding ICAO Standards and Recommended Practices and has identified the following differences with this final rule. ICAO Annex 6, Part 1, Paragraph 4.2.1.1 requires:

This regulatory change to allow the FAA acceptance of RSOO-issued AOCs for a member State does not comply with this standard.

The FAA has determined this regulatory change results in a different means of compliance to that of the standard in ICAO Annex 6, Part 1, paragraph 4.2.1.1. The FAA intends to notify ICAO of this difference.

FAA Order 1050.1F identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act (NEPA) in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 5-6.6f for regulations and involves no extraordinary circumstances.

The FAA has analyzed this final rule under the principles and criteria of Executive Order 13132, Federalism. The FAA has determined that this action will not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, will not have federalism implications.

Consistent with Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, 17 and FAA Order 1210.20, American Indian and Alaska Native Tribal Consultation Policy and Procedures, 18 the FAA ensures that Federally Recognized Tribes (Tribes) are given the opportunity to provide meaningful and timely input regarding proposed Federal actions that have the potential to have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes; or to affect uniquely or significantly their respective Tribes. At this point, the FAA has not identified any unique or significant effects, environmental or otherwise, on Tribes resulting from this final rule.

The FAA analyzed this final rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). The FAA has determined that it is not a “significant energy action” under the Executive order and is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

Executive Order 13609, Promoting International Regulatory Cooperation, promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The FAA has analyzed this action under the policy and agency responsibilities of Executive Order 13609. The FAA has determined that this action will eliminate differences between U.S. aviation standards and those of other civil aviation authorities in States where delegation or transfer of the responsibility for issuance of AOCs to an RSOO is permitted.

A copy of the NPRM, all comments received, this final rule, and all background material may be viewed online at www.regulations.gov using the docket number listed above. Electronic retrieval help and guidelines are available on the website. It is available 24 hours each day, 365 days each year. An electronic copy of this document may also be downloaded from the Office of the Federal Register's website at www.federalregister.gov and the Government Publishing Office's website at www.govinfo.gov . A copy may also be found on the FAA's Regulations and Policies website at www.faa.gov/regulations_policies .

Copies may also be obtained by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW, Washington, DC 20591, or by calling (202) 267-9677. Commenters must identify the docket or notice number of this rulemaking.

All documents the FAA considered in developing this final rule, including economic analyses and technical reports, may be accessed in the electronic docket for this rulemaking.

The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires the FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document may contact its local FAA official or the person listed under the FOR FURTHER INFORMATION CONTACT heading at the beginning of the preamble. To find out more about SBREFA on the internet, visit www.faa.gov/regulations_policies/rulemaking/sbre_act/ .

For the reasons discussed in the preamble, the Federal Aviation Administration amends 14 CFR part 129 as follows:

On December 6, 2024 (89 FR 96898), HUD published a final rule that adopts the 2020 Core Based Statistical Area (CBSA) standards as determined by the Office of Management and Budget's July 16, 2021, Federal Register notice for all HUD uses of CBSAs. The rule amended 24 CFR part 5 by adding a new subpart M. In reviewing the December 6, 2024, final rule, HUD identified an inadvertent error in § 5.3001. Specifically, HUD incorrectly designated two paragraphs as paragraph (e) and two paragraphs as paragraph (f). This document corrects these errors.

In FR Doc. 2024-28450, published December 6, 2024, at 89 FR 96898, the following corrections are made:

The final regulations (TD 10012) that are the subject of this correction are under sections 761(a), 6031(a), 6417(d) and (h), and 7805(a) of the Internal Revenue Code.

Accordingly, FR Doc. 2024-26944 (TD 10012), appearing on page 91552 in the Federal Register on Wednesday, November 20, 2024, is corrected as follows:

This rule outlines how an individual (inmate, staff member, or civilian) presents an administrative claim under the Federal Tort Claims Act to the Bureau of Prisons and explains the Bureau's procedures for processing such claims. After consideration of the one public comment, the Bureau finalizes the provisions of the interim rule and correcting amendment, while making minor edits to section 543.32(h).

On November 7, 2023, the Bureau published an interim final rule at 88 FR 76656 making minor revisions to regulations in 28 CFR part 543, subpart C—Federal Tort Claims Act, to clarify requirements for presenting claims and correct obsolete and/or correcting incorrect references to Bureau offices. On December 20, 2023, the Bureau published a correcting amendment at 88 FR 87903 to correct inadvertent errors and omissions in the interim rule. The correction was required for two reasons. First, we neglected to revise the headings of three paragraphs in § 543.31 to conform with the statement-like form of other paragraph headings we amended in the interim rule. Thus, the correction changed the headings of paragraphs (a), (b), and (e) in § 543.31 so that they are declarative rather than interrogative. Second, the third instruction in the interim rule omitted paragraphs (g) and (h) in § 543.32, so the regulatory text was not updated. Accordingly, the correction revised the instructions to include those missing paragraphs, thereby appropriately updating the Code of Federal Regulations.

Before, the comment period for the rule closed on January 8, 2024, we received one comment.

Comment: The commenter writes primarily about one of his own tort claims and argues in support of settlement of his claim. However, he makes two observations about the rule. First, he notes that the six-month investigatory period “might be a long time to let some problems fester.” Second, he suggests we add the following language in § 543.32: “The Associate General Counsel shall attempt to optimize any long-term benefits to prison operations and the public interest in reaching a settlement.”

Response: No response is required as to individualized disagreements with the general FTCA claim system, which are outside the scope of this rulemaking action, nor will the Bureau address the merits of any particular FTCA claim in this context.

The Bureau needs six months to fully investigate claims and to make informed decisions on whether to deny the claim or pursue settlement. This six‐month period is provided by statute, 28 U.S.C. 2675(a), and applies to all FTCA administrative claims presented to the required appropriate federal agency, no matter the agency involved. We decline to amend the rule based on this first suggestion.

Regarding the second suggestion, we note that Bureau legal staff already consider many factors in the settlement of administrative FTCA claims, including factors not specifically included in the regulations. For example, in evaluating each claim individually for settlement, the Bureau considers all information provided by the claimant, the investigation, relevant records, and applicable policy and legal authority. We also decline to amend the rule based on this second suggestion.

Upon further review of § 543.32(h), we decided to make two changes to that section to clarify the language and ensure it more closely aligns with the FTCA. The language of the second sentence to that section currently in effect via the interim final rule reads: “If you have not received a letter either proposing a settlement or denying your claim within six months after the date your claim was presented, you may assume your claim is denied.” The revised language included in the final rule reads: “If you have not received a letter denying your claim within six months after the date your claim was presented, you may deem the absence of a response to your claim as a denial.”

The first change is to the first clause of the second sentence in section § 543.32(h). We changed the language by removing the phrase “either proposing a settlement or” because we do not want to imply the Bureau's proposal of a settlement within six months precludes the option of the claimant deeming a claim denied. As discussed more in the next paragraph, what triggers the option for the claimant to deem a claim denied and to file suit is the failure of an agency to make a final disposition of a claim within six months. Since a settlement offer is not a “final disposition,” it cannot serve to preclude the claimant from filing suit.

The second change is to the second clause of the second sentence in § 543.32(h). In reviewing our draft of the final rule, we determined that use of the word “assume” in the second sentence to § 543.32(h) was unnecessary and confusing inasmuch as the statute itself, 28 U.S.C. 2675(a), does not mention “assumptions.” That language confers upon the claimant the “option” to deem their claim finally denied; the claimant is not required to “assume” that the sending of a settlement proposal means they are not entitled to file suit if six months have elapsed since presentment. Instead, the claimant retains the option to continue negotiating with no statute of limitations penalty, or they may opt instead to “deem” the claim denied and pursue a lawsuit in federal court.

Executive Orders 12866, 13563 and 14094. This rule does not fall within a category of actions that the Office of Management and Budget (OMB) has determined constitutes a “significant regulatory action” under section 3(f) of Executive Order 12866 and, accordingly, it was not reviewed by OMB. The economic impact of this final rule is limited to inmates in the custody of the Federal Bureau of Prisons.

Executive Order 13132. This rule will not have substantial direct effect on the States, on the relationship between the National Government and the States, or on distribution of power and responsibilities among the various levels of government. Therefore, under Executive Order 13132, the Bureau determines that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

Regulatory Flexibility Act. The Director of the Bureau of Prisons, under the Regulatory Flexibility Act (5 U.S.C. 605(b)), reviewed this rule and by approving it certifies that it will not have a significant economic impact upon a substantial number of small entities for the following reasons: This rule pertains to the correctional management of offenders committed to the custody of the Attorney General or the Director of the Bureau of Prisons, and its economic impact is limited to the Bureau's appropriated funds.

Unfunded Mandates Reform Act of 1995. This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

Congressional Review Act. This rule is a not major rule as defined by the Congressional Review Act, 5 U.S.C. 804.

Under rulemaking authority vested in the Attorney General in 5 U.S.C 301; 28 U.S.C. 509, 510 and delegated to the Director of the Bureau of Prisons in 28 CFR 0.96, the Bureau finalizes with minor changes, the interim rule published on November 7, 2023, (88 FR 76657) and the correction published on December 20, 2023 (88 FR 87903).

On February 7, 2024, BOP published an interim final rule that amended regulations related to attorney visits. 89 FR 8330 (Feb. 7, 2024). The comment period closed on April 8, 2024, and we received six comments. Of those six comments, only two were related to the rule; each of those comments is discussed more fully below. Of the four unrelated comments, one noted generally that BOP should review its regulations annually for improvement; one was mistakenly posted to this docket instead of to the docket for another BOP rulemaking; another laments the general treatment of January 6 defendants; and the last advocates for revised regulations regarding clergy visits to BOP facilities. After consideration of the two relevant public comments, BOP is adopting the interim final rule on this subject without change.

We received two relevant, substantive comments after publication of the interim final rule. Each comment is addressed below.

Comment 1: The commenter states that the revised rule does not go far enough to address other means that facilitate attorney-client communications, emphasizing that the availability of private telephone calls is essential to facilitate attorney-client communications. The commenter gave several examples where inmates and their attorneys encountered difficulties obtaining approval from officials at BOP institutions for unmonitored telephone calls. However, the commenter did not address the specific changes to the regulation addressing in-person visits by attorneys.

Response: BOP agrees that meaningful access to counsel includes reasonable access to unmonitored telephone calls to facilitate attorney-client communications. Through separate procedures, BOP enables confidential communications between an inmate and their attorney through legal visits, unmonitored telephone calls, and unmonitored legal correspondence. Title 28 CFR 540.102 and 540.103 address unmonitored telephone calls, while 28 CFR 540.18 and 540.19 address unmonitored legal correspondence.

However, the comment is out of scope as the interim final rule only addressed the procedures for in-person, confidential attorney visits as provided in Part 543, and did not address the different issue of rules applicable to telephone calls between inmates and their attorneys, which are in separate regulations at 28 CFR 540.102-540.103. To the extent the commenter's suggestion is intended to be construed as a petition for rulemaking pursuant to 5 U.S.C. 553(e), a comment to a rule pertaining to a different issue in a different set of regulations is not the proper mechanism to effectuate that provision. Individuals in BOP custody with individualized concerns or questions regarding the implementation of applicable regulations or policy are reminded of their rights to address such issues through the agency's Administrative Remedy Program, as outlined at 28 CFR part 542 and in BOP Program Statement 1330.18 (available at www.bop.gov/policy ). Thus, BOP concludes that no changes are needed in the final rule in light of this comment.

Comment 2: The commenter states that the rule should address attorney visits for individuals located at administrative facilities in holdover status; that the rule does not address circumstances where a pretrial or unsentenced individual is in holdover status at a BOP institution that houses convicted individuals; that BOP's explanation for the rule indicates that attorneys can visit a client in BOP custody like social visitors during normal visiting hours without advanced notice; that many attorneys are unwilling to be added to their client's regular social visiting list and that some attorneys are unwilling to provide personally identifying information on the social visit application forms; and that BOP should clarify if attorneys can show up at an institution during normal social visiting hours for a visit in the common area ( i.e., not in a private setting) without providing sensitive personal information.

Response: As background, BOP is responsible for the custody and care of sentenced federal inmates, felony offenders convicted and sentenced to a term of imprisonment under the DC criminal code a number of state and military offenders who are housed on a contractual basis, and pretrial detainees and pre-sentenced offenders housed in BOP facilities on behalf of the United States Marshals Service (USMS).

The USMS is responsible for the care and custody of individuals charged with a federal offense. Responsible for housing approximately 63,000 detainees, the USMS acquires detention bedspace through agreements with state and local governments in addition to available BOP pretrial cells. Approximately 75 percent of the detainees in the custody of the USMS are detained in state, local, and private facilities; the remainder are housed in BOP facilities. Ordinarily, pretrial inmates in BOP custody are housed in administrative institutions including Metropolitan Detention Centers (MDCs), Federal Detention Centers (FDCs), and Metropolitan Correctional Centers (MCCs). These institutions may also house convicted inmates awaiting sentencing or movement to designated institutions, or sentenced inmates who require further court appearances. A small number of other BOP institutions also house pretrial inmates in specific units within the main facility or in jail units located in satellite buildings separate from the main facility.

As explained in the preamble to the interim final rule, the prior version of § 543.13(c) provided that, to schedule any legal visit at any BOP institution, an attorney must make an advance appointment for a visit through the warden, and that the warden must make every effort to accommodate a legal visit when prior notification is not practicable. That prior rule was promulgated on June 27, 1979.

To clarify, the interim final rule updated § 543.13(c) to allow both scheduled and unscheduled attorney visits during designated attorney visitation hours at BOP institutions whose mission is to house pretrial detainees and unsentenced individuals. However, the rule retains the requirement that attorneys seeking to visit clients at BOP institutions whose mission is to house convicted individuals must make an advance appointment for a legal visit and that the warden must make every effort to accommodate a legal visit when prior notification is not practicable.

Attorney visits for holdover inmates. The term “holdover” refers to individuals in BOP custody who are transferring from one BOP institution to another. These individuals are categorized as being in holdover status until they arrive at the institution to which they are officially designated. The interim final rule did nothing more than allow both scheduled and unscheduled attorney visits during designated attorney visitation hours at BOP institutions that have a pretrial mission housing pretrial and unsentenced individuals, and it retains the requirement for an advanced appointment for attorney visits at all other BOP institutions. Accordingly, attorney visits with any individual in holdover status housed at an institution that does not have a pretrial mission must ordinarily make an advance appointment for a legal visit. Individuals in holdover status and their attorneys may coordinate legal visits in the same manner as the offender population at the particular facility in which the individual is temporarily housed en route to their designated institution. To clarify, it is the type of institution and its specific mission that are determinative for purposes of scheduling attorney visits; an individual's temporary status as a “holdover” is not determinative. Further changes to the rule addressing attorney visits for pretrial and unsentenced individuals on holdover status are unnecessary.

Adding attorneys to client's social visiting list. The commenter urges that this rule address the option for attorneys to be added to their client's social visiting list, but that subject is addressed by separate rules applicable to regular visitors at 28 CFR part 540, subpart D. In coordination with their client, attorneys may seek to be added to their client's regular social visiting list and visit under the same conditions as other visitors in accordance with part 540, subpart D.

Again, this comment is out of scope of what was addressed in the interim final rule. Such social visits are conducted in an open setting, not a confidential setting for attorneys to meet with their clients privately. By contrast, confidential attorney visits, which are the subject of this rule, are governed by part 543. To the extent the commenter's suggestion is intended to be construed as a petition for rulemaking pursuant to 5 U.S.C. 553(e), a comment to a rule pertaining to a different issue in a different set of regulations is not the proper mechanism to present such a petition. Thus, the BOP concludes that no changes are needed in the final rule in light of this comment.

The commenter also urges that the rule clarify whether attorneys are required to submit the same personal information as other visitors to be added to the inmate's approved social visitor list. As noted, attorneys may seek to be added to their client's regular social visiting list and visit under the same conditions as other visitors pursuant to separate rules applicable to regular visitors at 28 CFR part 540, subpart D, and the more granular details regarding the processing of social visits are addressed in the BOP policy implementing those provisions. The BOP declines to make changes to Part 543 in response to this comment.

For the foregoing reasons, we conclude that no changes are needed in the regulatory language in § 543.13(c) and (e) as adopted in the interim final rule, and that no other changes are needed in BOP's regulations in connection with this specific rulemaking action. Accordingly, this rule finalizes the interim final rule without change.

Executive Orders 12866, 13563 and 14094. This rule does not fall within a category of actions that the Office of Management and Budget (OMB) has determined constitutes a “significant regulatory action” under section 3(f) of Executive Order 12866 and, accordingly, it was not reviewed by OMB. The economic impact of this final rule is limited to inmates in the custody of the Bureau of Prisons and their attorneys.

Executive Order 13132. This rule will not have substantial direct effect on the States, on the relationship between the National Government and the States, or on distribution of power and responsibilities among the various levels of government. Therefore, under Executive Order 13132, BOP determines that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

Executive Order 12988—Civil Justice Reform (Plain Language). This final rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to specify provisions in clear language. Pursuant to section 3(b)(1)(I) of the Executive Order, nothing in this final rule or any previous rule (or in any administrative policy, directive, ruling, notice, guideline, guidance, or writing) directly relating to the Program that is the subject of this final rule is intended to create any legal or procedural rights enforceable against the United States.

Regulatory Flexibility Act. The Director of the Bureau of Prisons, under the Regulatory Flexibility Act (5 U.S.C. 605(b)), reviewed this rule and by approving it certifies that it will not have a significant economic impact upon a substantial number of small entities for the following reasons: This rule pertains to the correctional management of offenders and detainees committed to the custody of the Attorney General or the Director of the Bureau of Prisons, and its economic impact is limited to BOP's appropriated funds.

Unfunded Mandates Reform Act of 1995. This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (as adjusted for inflation) in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

Congressional Review Act. This rule is a not major rule as defined by the Congressional Review Act, 5 U.S.C. 804.

Section 6(a) of the FLSA requires covered employers to pay nonexempt employees a minimum wage of at least $7.25 per hour. See 29 U.S.C. 206(a). Since 1966, section 3(m) of the FLSA has permitted employers that meet certain requirements to satisfy a portion of their minimum wage obligation to a “tipped employee” by taking a partial credit, commonly known as a “tip credit,” toward the minimum wage based on the amount of tips that the tipped employee receives. 1 An employer that elects to take a tip credit cannot satisfy the entirety of the minimum wage requirement with tips because the employer must pay the tipped employee a direct cash wage of at least $2.13 per hour. 2 Based on the current Federal minimum wage of $7.25 per hour, the employer may claim a tip credit against its wage obligation of up to $5.12 per hour towards its minimum wage obligation for a tipped employee, provided—among other criteria—that the employee actually receives sufficient tips to earn not less than the FLSA minimum wage.

Section 3(t) of the FLSA defines a “tipped employee” as “any employee engaged in an occupation in which [the employee] customarily and regularly receives more than $30 a month in tips.”  3 The Department promulgated the original FLSA regulations for tipped employees in 1967, the year after Congress first created the tip credit provision. 4 As part of that rulemaking, the Department included a “dual jobs” provision, recognizing that an employee may be employed by the same employer both in a tipped occupation and in a non-tipped occupation, for example, “where a maintenance man in a hotel also serves as a waiter.” 29 CFR 531.56(e) (1967). 5 This provision explained that an employee is a “tipped employee” for the purposes of section 3(t) only while the employee is engaged in the tipped occupation, and their employer may take a tip credit against its minimum wage obligation only for the time the employee spends in that tipped occupation. Id. At the same time, the regulation recognized that tipped employees may perform “related” duties that are not “themselves . . . directed toward producing tips,” and used the example of a server who “spends part of her time” performing non-tipped duties, such as “cleaning and setting tables, toasting bread, making coffee and occasionally washing dishes or glasses.” Id. 6

On December 30, 2020, the Department published Tip Regulations Under the Fair Labor Standards Act (FLSA), 85 FR 86756 (2020 Tip Rule), a final rule revising various regulatory requirements related to the treatment of tipped employees under the FLSA. Among other changes, the 2020 Tip Rule would have revised the Department's original dual jobs regulation at 29 CFR 531.56(e) consistent with subregulatory guidance issued by the Department in 2018 and 2019, 7 but the dual jobs provisions in the 2020 Tip Rule never took effect.

The 2020 Tip Rule was published with a scheduled effective date of March 1, 2021. 8 However, on February 26, 2021, the Department delayed the effective date of the 2020 Tip Rule until April 30, 2021. 9 On March 25, 2021, the Department proposed to further delay the effective date of three portions of the 2020 Tip Rule, including the portion of the rule that would have amended the Department's dual jobs regulation, until December 31, 2021. 10 On April 29, 2021, the Department finalized the proposed partial delay. 11

On October 29, 2021, the Department published Tip Regulations Under the Fair Labor Standards Act (FLSA); Partial Withdrawal, 86 FR 60114 (2021 Dual Jobs Rule), which withdrew the dual jobs provisions of the 2020 Tip Rule. 12 Separately, the 2021 Dual Jobs Rule adopted at 29 CFR 531.56(e)-(f) a new dual jobs regulation, which—among other changes—set specific limits on the amount of time that tipped employees who are paid a direct cash wage which is less than the Federal minimum wage can spend performing “work that is not tip-producing, but directly supports tip-producing work.”  13 The 2021 Dual Jobs Rule took effect on December 28, 2021.

On October 29, 2024, the United States Court of Appeals for the Fifth Circuit issued a decision in Restaurant Law Center v. U.S. Department of Labor, vacating regulatory text codified at 29 CFR 531.56(e)-(f) from the Department's 2021 Dual Jobs Rule, with the effect of reinstating the Department's original dual jobs regulation. 115 F.4th 396 (5th Cir. 2024), superseded on reh'g (5th Cir. Oct. 29, 2024) (vacating the 2021 Dual Jobs Rule “insofar as it modifies 29 CFR 531.56 as promulgated in 1967”). Since the Fifth Circuit's mandate issued on October 29, 2024, the operative version of 29 CFR 531.56(e) is thus the dual jobs regulation that was in place on December 27, 2021, prior to the effective date of the 2021 Dual Jobs Rule.

Consistent with the Fifth Circuit's mandate, this rule amends 29 CFR 531.56 to reinstate the regulatory text as it appeared prior to the effective date of the 2021 Dual Jobs Rule. This action is a technical correction accounting for changes in the law which have already occurred.

Section 553(b)(B) of the Administrative Procedure Act (APA) provides that an agency is not required to publish a notice of proposed rulemaking in the Federal Register and solicit public comments when the agency has good cause to find that doing so would be “impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. 553(b)(B). The Department finds that good cause exists to dispense with public notice-and-comment rulemaking procedures in this final rule because such procedures are unnecessary. The final rule accounts for the effects of the Fifth Circuit's order in RLC, which already changed the operative regulatory provisions by vacating regulatory text codified at 29 CFR 531.56(e)-(f) from the Department's 2021 Dual Jobs Rule, with the effect of reinstating the Department's earlier original dual jobs regulation. The final rule makes technical non-substantive revisions to correct the CFR to reflect the court's mandate. These amendments ensure the accuracy of the CFR, but do not alter any regulatory obligations.

Section 553(d) of the APA provides that substantive rules should take effect not less than 30 days after the date they are published in the Federal Register unless “otherwise provided by the agency for good cause found[.]” 5 U.S.C. 553(d)(3). The Department finds that good cause also exists to make this final rule immediately effective because a delayed effective date is unnecessary and contrary to the public interest. A delayed effective date is unnecessary because the Fifth Circuit's order vacating regulatory text codified at 29 CFR 531.56(e)-(f) from the Department's 2021 Dual Jobs Rule has already taken effect. Delaying the ministerial act of removing the regulatory text of the vacated rule and restoring the operative regulatory text in the Federal Register would also be contrary to the public interest in light of the Department's need to expediently implement the court's final judgment, and because it could lead to confusion, particularly among employers and tipped employees, about the FLSA's requirements for the payment of minimum wages to tipped employees. The Department concludes that a delayed effective date is both unnecessary and is contrary to the public interest, providing good cause to bypass a delayed effective date.

The Regulatory Flexibility Act of 1980 (RFA) as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), hereafter jointly referred to as the RFA, requires that an agency prepare an initial regulatory flexibility analysis (IRFA) when proposing, and a final regulatory flexibility analysis (FRFA) when issuing, rules that will have a significant economic impact on a substantial number of small entities. However, the RFA only applies to “rule[s] for which the agency publishes a general notice of proposed rulemaking pursuant to section 553(b) of this title, or any other law.”  14 Because the Department has determined for good cause that public notice and comment is not required, the Department is not publishing a notice of proposed rulemaking for this final rule to comply with the court's order. Therefore, the RFA and its procedural requirements do not apply.

Under Executive Order 12866 (as amended by Executive Order 14094), OMB's Office of Information and Regulatory Affairs (OIRA) determines whether a regulatory action is significant and, therefore, subject to the requirements of the Executive order and OMB review. As amended by Executive Order 14094, section 3(f) of Executive Order 12866 defines a “significant regulatory action” as a regulatory action that is likely to result in a rule that may: (1) have an annual effect on the economy of $200 million or more; or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, territorial, or Tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees or loan programs or the rights and obligations of recipients thereof; or (4) raise legal or policy issues for which centralized review would meaningfully further the President's priorities or the principles set forth in the Executive order.

Executive Order 13563 directs agencies to, among other things, propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs; that it is tailored to impose the least burden on society, consistent with obtaining the regulatory objectives; and that, in choosing among alternative regulatory approaches, the agency has selected those approaches that maximize net benefits. Executive Order 13563 recognizes that some costs and benefits are difficult to quantify and provides that, when appropriate and permitted by law, agencies may consider and discuss qualitatively values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts. OIRA has determined that this final rule is not significant for the purpose of Executive Orders 12866 and 13563.

Before a rule can take effect, 5 U.S.C. 801, the Congressional Review Act (CRA) requires agencies to submit the rule and a report indicating whether it is a major rule to Congress and the Comptroller General. This final rule does not qualify as a major rule for purposes of the CRA and is therefore not subject to the timing requirements provided in 5 U.S.C. 801(a)(3).

The Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531-38, requires agencies to consider whether a rule will result in the expenditure of $100,000,000 or more (adjusted annually for inflation) in any one year by State, local, and Tribal governments, in the aggregate, or by the private sector. This technical amendment will not result in such an expenditure.

The Department has (1) reviewed this proposed rule in accordance with Executive Order 13132 regarding federalism and (2) determined that it does not have federalism implications. The proposed rule would not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.

The Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq., and its attendant regulations, 5 CFR part 1320, require the Department to consider the agency's need for its information collections, their practical utility, the impact of paperwork and other information collection burdens imposed on the public, and how to minimize those burdens. The PRA typically requires an agency to provide notice and seek public comments on any proposed collection of information contained in a proposed rule. See 44 U.S.C. 3506(c)(2)(B); 5 CFR 1320.8. The final rule is also not subject to the requirements of the PRA because it does not contain a collection of information as defined in 44 U.S.C. 3502(3).

The Department of the Treasury (Treasury) published a notice of proposed rulemaking (Systems Exemption NPRM) in the Federal Register , 89 FR 76783 (published September 19, 2024), proposing to exempt portions of the system of records from one or more provisions of the Privacy Act.

As background, on August 9, 2023, the President issued Executive Order 14105, 88 FR 54867 (the Outbound Order), which declares a national emergency to address the threat to the United States posed by countries of concern, which seek to develop and exploit sensitive technologies or products critical for military, intelligence, surveillance, or cyber-enabled capabilities. Among other things, the Outbound Order directs the Secretary of the Treasury to issue regulations that require U.S. persons to provide notification of information to Treasury regarding certain transactions involving a person of a country of concern that is engaged in certain activities involving covered national security technologies and products that may contribute to the threat to the national security of the United States as identified in the Outbound Order. The Outbound Order also directs the Secretary of the Treasury to issue regulations that prohibit certain transactions by a U.S. person involving a person of a country of concern that is engaged in certain activities involving covered national security technologies and products that pose a particularly acute national security threat to the United States. The Outbound Order authorizes the Secretary of the Treasury to exempt from applicable prohibitions or notification requirements any transaction determined to be in the national interest of the United States. On August 9, 2023, Treasury issued an advance notice of proposed rulemaking, 88 FR 54961 (published August 14, 2023), to explain initial considerations and seek public comment on implementation of the Outbound Order.

On June 21, 2024, Treasury issued a notice of proposed rulemaking to seek public comment on the proposed rule, 89 FR 55846 (published July 5, 2024). On October 28, 2024, Treasury issued a final rule, [89 FR 90398] (published November 15, 2024) (the Outbound Rule), setting forth the regulations that implement the Outbound Order. The Outbound Rule requires U.S. persons to provide notification of certain transactions. This information will include relevant details on the U.S. person(s) involved in the transaction as well as information on the transaction and the foreign person(s) involved. These notifications will increase the U.S. Government's visibility into transactions by U.S. persons or their controlled foreign entities and involving technologies and products relevant to the threat to the national security of the United States due to the policies and actions of countries of concern. These notifications would also be helpful in highlighting aggregate sector trends and related capital flows as well as informing future policy development. The Outbound Rule also requires any U.S. person seeking a national interest exemption for a particular transaction to submit information to Treasury regarding the scope of that transaction including, as applicable, the information that would be required for a notification under the Outbound Rule.

Treasury's Departmental Offices published separately the notice of a new system of records, 89 FR 76917 (published September 19, 2024), for information collected in connection with the implementation of the Outbound Order.

Treasury received five comments on the Systems Exemption NPRM. Four commenters support the proposed exemptions because of their importance to protect national security. One commenter urged Treasury to consider the importance of transparency and accountability in government, as well as the impact exemptions to the Privacy Act could have on public trust. The commenter expressed concern that the Systems Exemption NPRM was too broad and noted that exemptions to the Privacy Act should be clearly defined and limited to situations implicating national security. The commenter also questioned whether there were any checks and balances in place to ensure that data is only collected in the interest of national security and public safety.

Treasury notes the importance of transparency and accountability and the role of the Privacy Act in supporting those goals. As noted in the Systems Exemption NPRM, notification is limited to those transactions that may contribute to the threat to the national security of the United States identified in the Outbound Order, and the scope of notifiable transactions is linked to subsets of technologies and products and based on specific descriptions and technical thresholds provided in the Outbound Rule. In addition, the specific information required to be submitted to Treasury in the notifications is a limited universe of information related to the relevant transaction. Furthermore, as noted in the Outbound Rule, Treasury recognizes the importance of safeguarding sensitive information and has included specific confidentiality provisions in the regulations. Among the checks and balances in place, the Outbound Order requires annual reports be submitted to the President with an assessment of the effectiveness of the measures imposed under the Outbound Order in addressing threats to the national security of the United States, among other things. Treasury makes no changes to this final rule in response to these comments.

Treasury is hereby promulgating a final rule to exempt the Outbound Investment Security Program Notification System from certain provisions of the Privacy Act pursuant to 5 U.S.C. 552a(k)(1) and (k)(2) and the authority vested in the Secretary of the Treasury by 31 CFR 1.23(c).

Under 5 U.S.C. 552a(k)(1), the head of a Federal agency may promulgate rules to exempt a system of records from certain provisions of 5 U.S.C. 552a if the system of records is subject to the exemption contained in section 552(b)(1) of this title. (Freedom of Information Act, exemption (b)(1) protects from disclosure information that has been deemed classified “under criteria established by an Executive order to be kept secret in the interest of national defense or foreign policy” and is “in fact properly classified pursuant to such Executive order.”)

Under 5 U.S.C. 552a(k)(2), the head of a Federal agency may promulgate rules to exempt a system of records from certain provisions of 5 U.S.C. 552a if the system of records contains investigatory materials compiled for law enforcement purposes that are not within the scope of subsection (j)(2) of the Privacy Act (which applies to agencies and components thereof that perform as their principal function any activity pertaining to the enforcement of criminal laws).

To the extent that this system of records contains classified information protected by 5 U.S.C. 552a(k)(1) or investigatory materials compiled for law enforcement purposes protected by 5 U.S.C. 552a(k)(2), Treasury exempts the following system of records from various provisions of the Privacy Act:

Under 5 U.S.C. 552a(k)(1) and (k)(2), Treasury exempts certain records in the above-referenced system of records be exempt from 5 U.S.C. 552a(c)(3), (d)(1) through (4), (e)(1), (e)(4)(G) through (I), and (f) of the Privacy Act. See 31 CFR 1.36.

The following are the reasons why the classified records and investigatory materials contained in the above-referenced system of records may be exempted from various provisions of the Privacy Act pursuant to 5 U.S.C. 552a(k)(1) and (k)(2).

1. 5 U.S.C. 552a(c)(3) requires an agency to make any accounting of disclosures of records required by 5 U.S.C. 552a(c)(1) available to the individual named in the record upon his or her request. Exemption from this requirement is appropriate because release of the accounting of disclosures of the records in this system could alert individuals whether they have been identified as the subject of an analysis related to the national security interests of the United States, to the existence of the analysis, and reveal the interest on the part of Treasury as well as the recipient agency. Disclosure of the accounting would present a serious impediment to efforts to protect national security interests by giving individuals an opportunity to learn whether they have been identified as subjects of a national security-related analysis. As further described in the following paragraph, access to such knowledge would impair Treasury's ability to carry out its mission, since individuals could:

i. Take steps to avoid analysis;

ii. inform associates that a national security analysis is in progress;

iii. learn the nature of the national security analysis;

iv. learn the scope of the national security analysis;

v. begin, continue, or resume conduct that may pose a threat to national security upon inferring they may not be part of a national security analysis because their records were not disclosed; or

vi. destroy information relevant to the national security analysis.

2. 5 U.S.C. 552a(d)(1) through (4) grant individuals access to records containing information about them and permit them to request amendment of a record pertaining to them and require the agency either to amend the record or note the disputed portion of the record and, if the agency refuses to amend the record, to provide a copy of the individual's statement of disagreement with the agency's refusal, to persons or other agencies to whom the record is thereafter disclosed. Exemption from this requirement is appropriate because access to a portion of the records contained in this system of records could inform individuals whether they have been identified as the subject of an analysis related to the national security interests of the United States, to the existence of the analysis and reveal the interest on the part of Treasury or another agency. Access to the records would present a serious impediment to efforts to protect national security interests by permitting the individual who is the subject of a record to learn whether they have been identified as a subject of a national security-related analysis. Access to such knowledge would impair Treasury's ability to carry out its mission, since individuals could take steps to impede the analysis and avoid detection, including the steps described in paragraph 1.i-through vi of this section. Amendment of the records would interfere with ongoing analysis and impose an impossible administrative burden. The information contained in the system may also include classified information, the release of which would pose a threat to the national security of the United States. In addition, permitting access and amendment to such information could disclose sensitive security information that could be detrimental to Treasury.

3. 5 U.S.C. 552a(e)(1) requires an agency to maintain in its records only such information about an individual as is relevant and necessary to accomplish a purpose of the agency required to be accomplished by statute or Executive order. Exemption from this requirement is appropriate because what information is relevant and necessary may not always be apparent at the time of collection. In the interests of national security, it is appropriate to include a broad range of information that may aid in identifying and assessing the nature and scope of national security threats to the United States. Additionally, the accuracy of information obtained or introduced occasionally may be unclear, or the information may not be strictly relevant or necessary to a specific analysis. In the interests of national security, it is appropriate to retain all information that may aid in establishing patterns of suspicious activity.

4. 5 U.S.C. 552a(e)(4)(G) through (I) and 5 U.S.C. 552a(f) require an agency to publish the agency procedures whereby individuals can be notified if the system of records pertains to them, how they can gain access to any record pertaining to them in the system of records and contest its content, and the categories of sources of records in the system. Exemption from these requirements is appropriate because, as noted above, this system is exempt from the access and amendment provisions of subsection (d).

Any records from another Treasury system of records or another Executive Branch agency's system of records for which an exemption is claimed under 5 U.S.C. 552a(j) or (k) that may also be included in this system of records retains the same exempt status as such records have in the system for which such exemption is claimed.

This rule is not a “significant regulatory action” under Executive Order 12866. Pursuant to the requirements of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., it is hereby certified that this rule will not have a significant economic impact on a substantial number of small entities. This rule, issued pursuant to 5 U.S.C. 552a(k), exempts certain information maintained by Treasury in the above-referenced systems of records from certain provisions of the Privacy Act. Small entities, as defined in the RFA, are not provided rights under the Privacy Act and are outside the scope of this regulation.

The related information collections have been submitted to the Office of Management and Budget on July 8, 2024 under control number: 1505-0282.

For the reasons stated in the preamble, part 1 of title 31 of the Code of Federal Regulations is amended as follows:

I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port Sector Southeastern New England DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section TIR Temporary interim rule U.S.C. United States Code II. Background Information and Regulatory History

This temporary interim rule (TIR) amends the current temporary safety zone in the vicinity of the West Passage Narraganset Bay, Jamestown, RI. An earlier TIR published on August 29, 2024, established the first safety zone regulation for that waterway in 33 CFR 165.T01-0559 (89 FR 70100).

The Coast Guard is issuing this temporary rule under the authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The recently changed details of the project were not known to the Coast Guard in sufficient time to publish an NPRM. Delaying the effective date of this rule to wait for a comment period to run would be impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect the public and vessels from the hazards associated with the cable laying process. The expeditious implementation of this rule is in the public interest because it will help ensure the safety of personnel, waterway users, and the marine environment.

Also, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable because prompt action is needed to respond to the potential safety hazards associated with the cable installation being conducted by the cable laying vessel SKAGERRAK and the J.F. Brennan construction barge #4132.

Although the first regulation was published as an interim rule without prior notice, public comment was nevertheless desirable to ensure that the regulation is both workable and reasonable. No comments were received during a 30-day comment period that ended September 30, 2024. Accordingly, an additional 30-day comment period for this temporary interim rule will allow persons wishing to comment to do so by submitting written comments as set out under ADDRESSES in this preamble. Commenters should include their names and addresses, identify the docket number for the regulation, and give reasons for their comments. If the Coast Guard determines that changes to the temporary interim rule are necessary, we will publish a temporary final rule or other appropriate document.

The Coast Guard is issuing this rule under the authority in 46 U.S.C. 70034. The Captain of the Port Sector Southeastern New England (COTP) has determined that potential hazards associated with the cable installation that started on September 1, 2024, will be a safety concern for anyone within a 250-yard radius of the cable laying vessel SKAGERRAK and the J.F. Brennan construction barge #4132. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the cable installation is being conducted.

The Coast Guard is making the following amendments to the current temporary safety zone in the vicinity of the West Passage Narraganset Bay, Jamestown, RI, for cable laying operations:

i. We are extending the rule for an additional 30 days to allow for delays and a change to the process to the cable laying operations. The existing safety zone was effective until 11:59 p.m. December 31, 2024. The 30-day extension will now be effective until 11:59 p.m. on January 31, 2024. While the safety zone will be effective through this period, it will only be enforced during active submerged cable laying operations or other instances which may create a hazard to navigation.

ii. We are changing the name of the vessel that will be engaged in the cable laying operations. The existing safety zone was for the MARMAC 306 cable laying barge. The Coast Guard is establishing a safety zone that will cover all navigable waters within 250 yards of the barge cable laying vessel SKAGERRAK and the J.F. Brennan construction barge #4132 while they are engaged in cable laying operations in the vicinity of the West Passage Narraganset Bay, Jamestown, RI, between the Jamestown Verrazzano Bridge (41°31′43.7″ N 71°24′18.2″ W) and south to Dutch Island (41°29′47.3″ N, 71°24′16.5″ W). During times of enforcement, all persons or vessels would be prohibited from entering the safety zone without permission from the COTP or a designated representative. If cable laying operations and associated operations are completed before 11:59 p.m. on January 31, 2025, enforcement of the safety zone will be suspended, and notice given via Broadcast Notice to Mariners.

These amendments are being made to maintain safe navigation in the project area and to prevent accidental or intentional damage to persons or property on the work site.

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

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

This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic will be able to safely transit around the safety zone which would impact a 250-yard radius around the cable laying vessel SKAGERRAK and the J.F. Brennan construction barge #4132 while engaged in cable laying operations. The Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone, lasting only during the hours of operation of the cable laying vessel SKAGERRAK and J.F. Brennan construction barge #4132, that will prohibit entry within 250 yards of vessels and machinery being used by personnel to install the cable. It is categorically excluded from further review under paragraph L60a of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

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

We view public participation as essential to effective rulemaking and will consider all comments and material received during the comment period. If we determine that changes to the temporary interim rule are necessary, the Coast Guard will publish a temporary final rule or other appropriate document. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

Submitting comments. We encourage you to submit comments through the Federal Decision-Making Portal at https://www.regulations.gov. To do so, go to https://www.regulations.gov, type USCG-2024-0559 in the search box and click “Search.” Next, look for this document in the Search Results column, and click on it. Then click on the Comment option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER INFORMATION CONTACT section of this proposed rule for alternate instructions.

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

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

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

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

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

On January 9, 2024, Entergy Nuclear Operation, Inc, notified the Coast Guard that they had provided all the required documentation for disestablishment to the U.S. Nuclear Regulatory Commission as per 10 CFR 50.82(a)(1)(i). Power operations have ceased at the Pilgrim Nuclear Power Station.

In response, on August 30, 2024, the Coast Guard published a NPRM titled “Safety and Security Zones; Pilgrim Nuclear Power Plant, Plymouth Massachusetts” in the Federal Register (89 FR 70587). There we stated why we issued the NPRM and invited comments on our proposed regulatory action related to Safety and Security Zones: Pilgrim Nuclear Power Plant, Plymouth, Massachusetts. During the comment period that ended September 30, 2024, we received three written submissions.

The Coast Guard is issuing this rule under the authority in 46 U.S.C. 70034, 70051, and 70124. The Captain of the Port Sector Boston Massachusetts (COTP) has determined that disestablishing the safety and security zone cited in 33 CFR 165.115, Safety and Security Zones: Pilgrim Nuclear Power Plant, Plymouth Massachusetts, by removing that section.

As noted above the Coast Guard received three written submissions on our NPRM published on August 30, 2024. All three commenters were in favor of our proposal, no Public Meetings were requested or held. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM. The Coast Guard is disestablishing the safety and security zone cited in 33 CFR 165.115, Safety and Security Zones: Pilgrim Nuclear Power Plant, Plymouth, Massachusetts, by removing that section.

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

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

This regulatory action determination is based on the need to align the regulations with the current arrangements of the port as the waterfront facility safety and security zone is no longer required. The Captain of the Port of Boston Massachusetts is removing 33 CFR 165.115.

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 would not have a significant economic impact on a substantial number of small entities.

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 would not result in such an expenditure, we do discuss the potential 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 made a preliminary determination 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 the disestablishment of a security zone. Normally such actions are categorically excluded from further review under paragraph L60(b) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

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

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

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

The background for this action is discussed in detail in our August 2, 2024, proposal. 2 In that document, we proposed to determine that the Rusk-Panola area failed to attain the 2010 1-hour SO 2 NAAQS by the statutory attainment date of January 12, 2022. This proposed determination is based on the air quality, as evidenced by emissions and monitoring data, in the Rusk-Panola nonattainment area as of the January 12, 2022, attainment date.

In response to the August 2, 2024, proposal, we received several comments concerning our proposed finding of failure to attain by the January 12, 2022, attainment date. This final notification will only address comments on the finding of failure to attain by the attainment date portion of the proposal. Other comments on the August 2, 2024, proposal, including comments addressing the limited approval and limited disapproval, will be addressed in a future document. After careful consideration of public comments, the EPA is finalizing our proposed finding that the Rusk-Panola area has failed to attain the 2010 1-hour SO 2 NAAQS by the January 12, 2022, attainment date. In the following section, the EPA is providing responses to the relevant comments received on the proposal pertaining to the finding of failure to attain for the Rusk-Panola area.

Comment: The commenter, Texas Commission on Environmental Quality, requested that, upon finalization of the EPA's finding of failure to attain for the Rusk-Panola area, the deadline for the resulting SIP submittal requirement should be no earlier than 18 months from the effective date of the finding.

Response: CAA section 179(d)(1) explicitly states that if the EPA determines that an area did not attain the NAAQS by the applicable attainment date, “[w]ithin 1 year after the Administrator publishes the notice . . . relating to notice of failure to attain,” the responsible State “shall submit a revision to the applicable implementation plan” that meets the requirements of CAA section 179(d)(2) ( i.e., a SIP for the area that demonstrates attainment and shall include any additional measures that the EPA may reasonably prescribe, including all measures that can be feasibly implemented in the area in light of technological achievability, costs, and any non-air quality and other air quality-related health and environmental impacts as required).

The request from the commenter to extend the 12-month deadline for Texas to submit a revised SIP for the Rusk-Panola area is not permissible under the plain text of the CAA.

Comment: The commenter, Luminant Generation Company LLC, owner of the major source—Martin Lake facility (Luminant), claims that the EPA's proposed finding of failure to attain the 2010 1-hour SO 2 NAAQS is unsupported and should not be finalized. The commenter states that the Agreed Order containing the emissions limitations for the Martin Lake facility requires compliance by the attainment date and “simply phases in one additional control measure after the attainment date.” The commenter states that the EPA provided no evidence that the provisions implemented by the attainment date were insufficient to provide for attainment.

Another commenter, Sierra Club, offered support for EPA's finding and supporting evidence, stating that the EPA must determine attainment based on the area's design value as of the attainment date, and whether the area attained the standard by that date. The commenter references support for the EPA's finding in Texas's own monitoring data for 2019-2021—the time period with three full calendar years of data before the January 12, 2022, attainment date. The commenter then references EPA's proposal for this action, arguing the data in that proposal makes clear that the Martin Lake area did not meet the 2010 1-hour SO 2 NAAQS by the January 12, 2022, statutory attainment date.

Response: We disagree with the commenter Luminant on the claim that the finding of failure to attain is unsupported, and we agree with commenter Sierra Club that monitoring showing a violating design value for this area as of the attainment date is a sufficient basis for the EPA to find that the area failed to attain by its attainment date. The attainment date for the area was January 12, 2022. The EPA may only determine an area attained based on air quality monitoring data when the design value, based on complete, quality assured monitored air quality data from three consecutive calendar years (here, 2019-2021), at each eligible monitoring site is equal or less than the 75 ppb NAAQS. The Martin Creek monitoring site located within the Rusk-Panola area shows a 2019-2021 design value of 93 ppb in violation of the 2010 1-hour SO 2 NAAQS, and thus, the EPA is making the determination that the Rusk-Panola area did not attain by its statutory attainment date of January 12, 2022. 3 We also note that the 2020-2022 monitoring period (which goes beyond the attainment date) produced a design value of 81 ppb, also a violation of the 2010 1-hour SO 2 NAAQS.

The commenter Luminant's claims regarding the timing of the controls in the Agreed Order are therefore irrelevant to EPA's finding that the Rusk-Panola area failed to attain by the attainment date. The monitoring data evaluated prior to the attainment date is sufficient to support a finding of failure to attain.

While not determinative in light of the ambient monitoring data discussed above, we note that, regardless of the text of the Agreed Order, the Order was not entered into by the parties or enforceable until one month after the attainment date of January 12, 2022  4 In fact, one provision of the Agreed Order included a compliance deadline set for six months after the attainment date.

Commenter Luminant claims that a delay in compliance past the attainment date for the “additional control measure” ( i.e. the lb/MMBtu limits discussed in the preceding paragraph) established in the Agreed Order would not have a negative effect on the area attaining the standard. However, the modeling demonstration and statements made by TCEQ in the SIP refute Luminant's contention; both the modeling demonstration and TCEQ's statements establish that meeting these limits is necessary to ensure no modeled exceedances of the NAAQS. 5 Further, the commenter offers no evidence, modeling, or demonstration to support their claims that compliance with all of the SIP requirements (as provided for in the attainment demonstration modeling) was not necessary, and, monitoring data from the time period in question directly refutes commenter's position. Between January 12, 2022, and July 11, 2022, four exceedances of the standard were measured at the Martin Creek monitor in Rusk County, 6 suggesting that the area could not attain without the limits that had not yet taken effect.

Comment: One commenter, Sierra Club, stated that in addition to the EPA's finding of failure to attain by the attainment date for the Rusk-Panola area, the EPA should also prescribe additional measures that Texas must implement as expeditiously as practicable for the area to attain the standard.

Response: In accordance with CAA section 179(d), issuance of this finding of failure to attain triggers the requirement for the State of Texas to submit a SIP revision for the Rusk-Panola area within one year of the publication date of this document. The required SIP revision for the area must, among other elements, demonstrate attainment of the SO 2 NAAQS as expeditiously as practicable, but no later than 5 years from the date of this document. CAA section 179(d) also grants authority to the Administrator to reasonably prescribe additional measures that must be addressed, including all measures that can be feasibly implemented in the area in light of technological achievability, costs, and any non-air quality and other air quality-related health and environmental impacts. We are not prescribing additional measures for the SO 2 SIP revisions under CAA section 179(d)(2) in this document.

Under CAA section 179(c)(1)-(2), the EPA is making a determination that the Rusk-Panola area has failed to attain the 2010 1-hour SO 2 NAAQS of 75 ppb by the applicable statutory attainment date of January 12, 2022. In accordance with CAA section 179(d), issuance of this finding of failure to attain triggers the requirement for the State of Texas to submit a SIP revision for the Rusk-Panola area within one year of the publication date of this document. The required SIP revision for the area must, among other elements, demonstrate attainment of the 2010 1-hour SO 2 NAAQS as expeditiously as practicable, but no later than 5 years from the date of this document and shall include such additional measures as the Administrator may reasonably prescribe, including all measures that can be feasibly implemented in the area in light of technological achievability, costs, and any non-air quality and other air quality-related health and environmental impacts. At this time, we are not prescribing additional measures for the SO 2 SIP revisions under CAA section 179(d)(2). In addition to triggering requirements for a new SIP submittal, a final determination that a nonattainment area failed to attain the NAAQS by the attainment date triggers the implementation of contingency measures adopted under 172(c)(9).

Information on Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994) and how EPA defines environmental justice (EJ) can be found in the section titled “V. Statutory and Executive Order Reviews.” EPA provided analysis of environmental justice associated with this action solely for informational purposes, and the results of this analysis were presented in our proposal.

In accordance with section 179(c)(1)-(2) of the CAA, this final action formalizes EPA's determination that the Rusk and Panola Counties, Texas SO 2 nonattainment area has failed to attain the 2010 one-hour SO 2 NAAQS of 75 ppb by the applicable attainment date of January 12, 2022. This action provides notice to the public that the area has failed to attain the NAAQS and informs the State of Texas of CAA requirements the State needs to meet. After publishing this final rule, the State of Texas is required under CAA section 179(d) to submit revisions to the SIP for the Rusk-Panola area within one year of the publication of this document. The required SIP revision for the area must, among other elements, demonstrate attainment of the 2010 1-hour SO 2 NAAQS as expeditiously as practicable, but no later than 5 years. This final rule is not anticipated to have disproportionately high or adverse human health or environmental effects on communities with environmental justice concerns.

This action finds that an area has failed to attain the NAAQS by the relevant attainment date and does not impose additional or modify existing requirements. For that reason, this action:

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

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

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

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

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

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

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

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

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications and will not impose substantial direct costs on Tribal governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, Feb. 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on communities with environmental justice (EJ) concerns to the greatest extent practicable and permitted by law. Executive Order 14096 (Revitalizing Our Nation's Commitment to Environmental Justice for All, 88 FR 25251, April 26, 2023) builds on and supplements E.O. 12898 and defines EJ as, among other things, the just treatment and meaningful involvement of all people, regardless of income, race, color, national origin, or Tribal affiliation, or disability in agency decision-making and other Federal activities that affect human health and the environment.

TCEQ did not evaluate EJ considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. Consistent with EPA's discretion under the CAA, EPA has evaluated the EJ considerations of this action, as is described in the proposed action at 89 FR 63117 (August 2, 2024) in the section titled, “EJ Considerations.” Due to the nature of the action being taken here, this action is expected to have a neutral to positive impact on the air quality of the affected area. In addition, there is no information in the record inconsistent with the stated goal of E.O. 12898/14096 of achieving EJ for communities with EJ concerns.

This action is exempt from the Congressional Review Act because it is a rule of particular applicability. The rule makes factual determinations for an identified entity (the Rusk-Panola area of Texas), based on facts and circumstances specific to that entity. The determination of failure to attain the 2010 SO 2 NAAQS does not in itself create any new requirements beyond what is mandated by the CAA.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 18, 2025. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

For the reasons stated in the preamble, the Environmental Protection Agency amends 40 CFR part 52 as follows:

Throughout this document, wherever “we” or “our” is used, it means the EPA.

On September 27, 2024 (89 FR 79195), The EPA proposed to take the following four separate but related actions: (1) determine that the Whatcom County area is attaining the 2010 1-hour SO 2 NAAQS; (2) approve Washington's plan for maintaining the 2010 1-hour SO 2 NAAQS (maintenance plan), including proposed approval of a “reproducible approach” to representing the air quality of the affected area; (3) redesignate the Whatcom County area to attainment for the 2010 1-hour SO 2 NAAQS; and (4) determine that the Whatcom County area has clean monitoring data.

The public comment period for the proposed actions closed on October 28, 2024. We received two anonymous comments, document EPA-R10-OAR-2024-0371-0014 (comment #1) and EPA-R10-OAR-2024-0371-0015 (comment #2). Both comments expressed support for the EPA's approval of Washington's redesignation request and maintenance plan. However, comment #1 and comment #2 raised concerns about Washington's ability to verify continued attainment. In addition, comment #2 suggested the contingency measures contain more specificity and that Washington should include a public accessibility plan in its Maintenance Plan. The full text of the comments may be found in the docket for this action, and we have responded to the relevant comments in section II. of this preamble. Under the Clean Air Act (CAA), the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve State choices, provided that they meet the criteria of the CAA.

Comment: The EPA's proposed rulemaking provided a synopsis of Washington's strategy for verification of continued attainment in the area as part of the State's maintenance plan. 1 A more detailed explanation of Washington's “reproducible approach” to representing air quality, submitted to allow future monitor system modification under 40 CFR 58.14(c)(3), was provided in the maintenance plan itself. 2 With respect to this issue, comment #1 contains the statement, “although this has well solidified evidence, it is necessary to continue monitoring the nonattainment and attainment areas of Whatcom County to ensure the air quality stays in line with the EPA's NAAQS. If the EPA did approve the request from Washington State it would further confirm the EPA's dedication to implementing their own policies.” Comment #2 states, “while the plan allows for flexibility in adjusting SO 2 monitoring sites, it is crucial to consider that SO 2 impacts often disproportionately affect vulnerable communities. Could the EPA establish clearer criteria or a more rigorous review process before relocating or decommissioning monitors? This would ensure that communities previously affected by emissions from the Intalco facility continue to have adequate air quality protections, even in the absence of a large point source.”

Response: We agree that Washington's maintenance plan should contain provisions for monitoring air quality in the area and verifying continued attainment. As discussed in the preamble to the proposed rulemaking, the maintenance plan contains these provisions and otherwise meets the maintenance plan requirements in CAA section 175A and the EPA's associated guidance. 3 Neither comment directly addresses the EPA's evaluation of these provisions in the preamble to the proposed rulemaking nor provides a basis for disapproving Washington's maintenance plan. To the extent the comments imply that the maintenance plan is inadequate to monitor and verify continued attainment or lacks specificity in this regard, we disagree. The following discussion summarizes Washington's approach to monitoring air quality in the area post-redesignation and verifying continued attainment.

In the EPA's December 2020 technical support document for the nonattainment designation, we determined the region of violation was most likely due to plume downwash at the Intalco facility during certain wind conditions, that the modeled area of violation did not extend far from the Intalco facility fence line, that the gradient of concentration near the areas of violation was steep, quickly dropping with distance from the Intalco facility fence line, and that other nearby industrial facilities did not sufficiently contribute to violations of the 1-hour primary SO 2 NAAQS to warrant inclusion in the nonattainment area boundary. 4 In our final nonattainment boundary determination, we concurred with the Washington Department of Ecology (Ecology) and Northwest Clean Air Agency (NWCAA) that the boundary should be drawn to encompass the cause of the SO 2 violations, the Intalco facility.

With the permanent closure of the Intalco facility, Washington's comprehensive emissions inventory, prepared as part of the maintenance plan, shows no remaining significant sources of SO 2 , including mobile or area source emissions. 5 Therefore, in the absence of any current SO 2 emission sources, Washington's monitoring network and verification of continued attainment strategy focused on potential future emission sources that may be located within the area. 6

As described in our proposed rulemaking and the State's maintenance plan, the new source review (NSR) program ensures that any single facility applying for a permit to locate within the area complies with the NAAQS and other regulatory requirements. 7 In addition, Washington's maintenance plan included a stepwise process for assessing the cumulative impacts of new sources constructed in the area and triggering deployment of SO 2 monitors. This process ensures that cumulative impacts remain below the NAAQS should multiple facilities move to the area. Under the maintenance plan verification of continued attainment provisions, Washington, with NWCAA as the lead agency for the jurisdiction in coordination with Ecology, will evaluate the cumulative impacts of the new source or modifications using three sequential “Action Levels.”

Under Action Level 1, Washington will conduct cumulative dispersion modeling using potential emissions if two conditions are met: (1) the cumulative potential SO 2 emissions in the area are greater than or equal to 250 tons per year of SO 2 and (2) the proposed new source or modification has the potential to emit 40 tons per year of SO 2 (the significant emission rate under the major NSR program). Washington will use the EPA's preferred screening and dispersion modeling tools identified in 40 CFR part 51 appendix W (“Appendix W”) as normally applicable for any source seeking a construction permit under the NSR program. If the results of the modeling under Action Level 1 indicate a design concentration of greater than or equal to 90% of the 1-hour NAAQS, then Washington will proceed to Action Level 2.

Under Action Level 2, Washington will conduct refined dispersion modeling that uses actual emissions from existing sources and potential emissions from the new source or modification. If the results of that modeling indicate a design concentration of greater than or equal to 50% of the 1-hour SO 2 NAAQS, then Washington will proceed to Action Level 3.

Under Action Level 3, Washington will deploy SO 2 ambient monitors within 1 year of the initial startup of the new source or modification. Any new monitors established for verification of continued attainment will be operated as State and Local Air Monitoring Stations (SLAMS) as part of Ecology's Primary Quality Assurance Organization (PQAO). Ecology will verify that monitor siting complies with 40 CFR part 58 appendix E (Probe and Monitoring Path Siting Criteria for Ambient Air Quality Monitoring) and will include any new site proposals in its annual Ambient Air Monitoring Network Plan. This plan is available for public inspection and comment for at least 30 days before its submission to the EPA by July 1 of each year. Any such proposal will be subject to review and approval by the EPA Regional Administrator, following the process described in 40 CFR 58.10.

Therefore, we disagree with the implication in comment #2 that the verification of continued attainment framework described in the State's maintenance plan lacked clear criteria or a rigorous review process. The commenter provided no details for improving the methodology or raising specific concerns with the presented framework.

With respect to the broader issue of protecting “communities previously affected by emissions from the Intalco facility” we agree with the commenter that these communities should be protected against future violations of health-based air quality standards. Washington's maintenance plan does so, and the commenter did not provide any specific reasons why the EPA should find to the contrary. We note that during the operation of the Intalco facility, the areas impacted by the elevated levels of SO 2 were very close to the facility's fence line and did not reach the nearby city of Ferndale. 8 More importantly, there are no current SO 2 sources in the area or SO 2 exposure risks. Current 2021-2023 design value SO 2 concentrations in the area are 3 parts per billion (ppb), much lower than the EPA's health-based NAAQS of 75 ppb.

With respect to monitoring, we reiterate that the current monitors were sited for the specific purpose of measuring building downwash impacts immediately surrounding the Intalco facility and thus are not necessarily suitable to assessing impacts to the surrounding community. 9 Accordingly, Washington included in its maintenance plan its reproducible approach to assessing future impacts on the community from new sources. This approach—coupled with NWCAA and Washington's NSR program—is adequate to ensure future development does not cause or contribute to a violation of the SO 2 NAAQS.

Comment: Comment #2 stated “while the contingency measures are well-defined, additional detail about specific control measures and response timelines would help reassure the public of the plan's robustness. Particularly, if SO 2 levels approach the National Ambient Air Quality Standards (NAAQS) threshold, having a more explicit list of immediate actions the EPA or the Northwest Clean Air Agency (NWCAA) would take would demonstrate the agency's commitment to rapid response in the event of future exceedances.”

Response: We disagree that Washington's contingency measures should be more specific. As discussed in the preamble of our proposed rulemaking, the only significant source of SO 2 in the area has permanently shut down, thus the cause of any potential future NAAQS exceedance is unknown. Therefore, Washington cannot develop specific contingency measures as part of its maintenance plan. 10 Rather, Washington committed to concrete trigger levels and timelines for determining the appropriate contingency measures, but did not include specific measures in its maintenance plan. Therefore, our position remains that Washington's maintenance plan contains such contingency provisions as the Administrator deems necessary to assure that the State will promptly correct any violation of the standard which occurs after the redesignation of the area as an attainment area. 11

Comment: Comment #2 stated “while I understand that the Clean Air Act may not require environmental justice analysis for this action, it would be prudent to consider the impacts of future sources or monitoring changes on historically marginalized communities. The inclusion of a public accessibility plan to provide real-time air quality data would support EPA's goals under Executive Order 12898, ensuring fair treatment and meaningful involvement of all residents in air quality decisions.”

Response: The EPA responded to the commenter's concern regarding monitoring changes in section II.A of this preamble. With respect to impacts of future sources, our proposed rulemaking discussed how the NSR permitting program is the mechanism the EPA, States, and local clean air agencies use to assess the impacts of future sources. Washington's SIP includes NWCAA Rule 300 which establishes the minor NSR program applicable to sources constructed or modified in the Ferndale Area. Under Rule 300, save for certain limited exemptions, sources with a potential to emit more than 2.0 tons per year (tpy) of SO 2 must obtain approval prior to construction. 12 NWCAA may not approve construction or modification unless, among other things, the source will employ best available control technology and allowable emissions will not cause or contribute to a violation of any NAAQS. 13 As to the latter, NWCAA may require modeling using the EPA guidelines in appendix W of 40 CFR part 51 to determine whether construction and operation of the source will cause or contribute to a violation of any NAAQS.

Washington's SIP also includes a major new source review program to regulate the construction and modification of major sources constructed or modified in the Ferndale Area. 14 In general, Washington's major NSR program incorporates by reference the Federal major NSR program at 40 CFR 52.21. The major NSR program applies to sources with a potential to emit of 100 tpy of any regulated NSR pollutant for certain listed source categories, and 250 tpy of any regulated NSR pollutant for unlisted sources. Regulated NSR pollutant includes pollutants for which the EPA has established a NAAQS. Similar to the minor NSR program, all sources subject to the major NSR program must obtain a permit before commencing construction. In order to obtain a permit, the source must, among other things, demonstrate the source will apply best available control technologies for each regulated NSR pollutant that the source has the potential to emit in significant amounts. In the case of SO 2 , the significant emissions rate is 40 tpy. In addition, the source must demonstrate through dispersion modeling that construction and operation of the source will not cause or contribute to a violation of any NAAQS or violate any prevention of significant deterioration increment. We believe the NSR permitting programs described above provide the best tools available for assessing impacts to communities from future sources.

For the reasons stated in our proposed rulemaking (89 FR 79195, September 27, 2024) and in section II. of this preamble, we are taking the following three separate but related final actions: (1) determining that the Whatcom County area is attaining the 2010 1-hour SO 2 NAAQS; (2) approving Washington's plan for maintaining the 2010 1-hour SO 2 NAAQS, including approval of a “reproducible approach” to representing the air quality of the affected area; and (3) redesignating the Whatcom County area to attainment for the 2010 1-hour SO 2 NAAQS.

Specifically, as described in our proposed rulemaking, the EPA has determined that the Whatcom County area is attaining the 2010 1-hour primary SO 2 NAAQS based on the most recent complete monitoring data for the three-year (2021-2023) design value period.

The EPA is approving the maintenance plan under the 2010 1-hour SO 2 NAAQS for the Whatcom County area into the Washington SIP (under CAA section 175A). The maintenance plan demonstrates that the area will continue to maintain the 2010 1-hour SO 2 NAAQS and includes a process to develop and implement contingency measures to remedy any future violations of the 2010 1-hour SO 2 NAAQS and procedures for evaluating potential violations.

The EPA has determined that the Whatcom County area has met the criteria under CAA section 107(d)(3)(E) for redesignation from nonattainment to attainment for the 2010 1-hour SO 2 NAAQS. On this basis, the EPA is approving Washington's redesignation request for the area. Accordingly, the EPA is revising the legal designation of the portion of Whatcom County designated nonattainment at 40 CFR 81.348 to attainment for the 2010 1-hour SO 2 NAAQS.

The EPA is not finalizing a Clean Data Determination for the Whatcom County area. As noted in our proposed rulemaking, the EPA proposed the option to finalize a clean data determination in the event that the EPA did not finalize the proposed redesignation. However, because the EPA is finalizing the redesignation of the area to attainment, it is not finalizing this portion of the proposal.

Under the CAA, redesignation of an area to attainment is an action that affects the status of a geographical area and does not impose any additional regulatory requirements on sources beyond those imposed by State law. A redesignation to attainment does not in and of itself create any new requirements, but rather results in the applicability of requirements contained in the CAA for areas that have been redesignated to attainment.

In addition, the Administrator is required to approve a SIP submission that complies with the provisions of the Clean Air Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act.

Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For these reasons, this final action:

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

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

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

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

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

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

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

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

Executive Order 12898 (Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on communities with environmental justice (EJ) concerns to the greatest extent practicable and permitted by law. The EPA defines EJ as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” The EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.” The Washington Department of Ecology did evaluate environmental justice considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. The EPA did not perform an EJ analysis and did not consider EJ in this action. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goal of Executive Order 12898 of achieving environmental justice for communities with EJ concerns.

In addition, this final action, pertaining to redesignation of the Whatcom County area and approval of a maintenance plan for the area, would not be approved to apply on any Indian reservation land or in any other area where the EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule would not have Tribal implications and would not impose substantial direct costs on tribal governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). Consistent with EPA policy, the EPA provided a consultation opportunity to Tribes located near the Whatcom County area, in letters dated July 25, 2024 and July 29, 2024, included in the docket for this action.

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 18, 2025. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR parts 52 and 81 are amended as follows:

EPA is required to determine whether areas designated nonattainment for an ozone NAAQS attained the standard by the applicable attainment date, and to take certain steps for areas that failed to attain (see CAA section 181(b)(2)). EPA's determination of attainment for the 2015 ozone NAAQS is based on a nonattainment area's design value (DV) as of the attainment date. 1

The 2015 ozone NAAQS is met at an EPA regulatory monitoring site when the DV does not exceed 0.070 parts per million (ppm). For the Moderate nonattainment areas for the 2015 ozone NAAQS addressed in this action, the attainment date was August 3, 2024. Because the DV is based on the three most recent, complete calendar years of data, attainment must occur no later than December 31 of the year prior to the attainment date ( i.e., December 31, 2023, in the case of Moderate nonattainment areas for the 2015 ozone NAAQS). As such, EPA's determinations for each area are based upon the complete, quality-assured, and certified ozone monitoring data from calendar years 2021, 2022, and 2023.

This action addresses eight areas in Illinois, Indiana, Michigan, Missouri, Ohio, and Wisconsin that were classified as Moderate for the 2015 ozone NAAQS as of the Moderate area attainment date of August 3, 2024. EPA is addressing the remaining areas, including the Missouri portion of the St. Louis area, in separate actions. Table 1 provides a summary of the DVs and the EPA's air quality-based determinations for the eight Moderate areas addressed in this action.

EPA is finding that the eight Moderate areas in Table 1 did not attain by their attainment dates, because their 2021-2023 DVs are greater than 0.070 ppm. If EPA determines that a nonattainment area classified as Moderate failed to attain by the attainment date, CAA section 181(b)(2)(B) requires EPA to publish a determination in the Federal Register , no later than 6 months following the attainment date, identifying each such area and identifying the applicable reclassification.

Under CAA section 181(b)(2)(A), the effect of this determination is that these eight areas will be reclassified by operation of law as Serious on the effective date of this final rule. The reclassified areas will then be subject to the Serious area requirement to attain the 2015 ozone NAAQS as expeditiously as practicable, but not later than August 3, 2027.

Once reclassified as Serious, the relevant States must submit to EPA the SIP revisions for these areas that satisfy the statutory and regulatory requirements applicable to Serious areas established in CAA section 182(c) and in the 2015 Ozone NAAQS SIP Requirements Rule (see 83 FR 62998, December 6, 2018). EPA is establishing deadlines for submitting SIP revisions for these reclassified areas in a separate action.

On October 26, 2015, EPA issued its final action to revise the NAAQS for ozone to establish a new 8-hour standard ( see 80 FR 65452, October 26, 2015). In that action, EPA promulgated identical tighter primary and secondary ozone standards designed to protect public health and welfare that specified an 8-hour ozone level of 0.070 ppm. Specifically, the standards require that the 3-year average of the annual fourth highest daily maximum 8-hour average ozone concentration may not exceed 0.070 ppm.

Effective on August 3, 2018, EPA designated 52 areas throughout the country as nonattainment for the 2015 ozone NAAQS (see 83 FR 25776, June 4, 2018). In a separate action, EPA assigned classification thresholds and attainment dates based on the severity of an area's ozone problem, determined by the area's DV (see 83 FR 10376, May 8, 2018). EPA established the attainment date for Marginal, Moderate, and Serious nonattainment areas as 3 years, 6 years, and 9 years, respectively, from the effective date of the final designations. Thus, the attainment date for Marginal nonattainment areas for the 2015 ozone NAAQS was August 3, 2021, the attainment date for Moderate areas was August 3, 2024, and the attainment date for Serious areas is August 3, 2027. On October 7, 2022 (87 FR 60897), EPA determined that 22 areas, including the eight areas addressed in this action, did not attain the standards by the Marginal attainment date, and these areas were reclassified as Moderate by operation of law.

The statutory authority for these determinations is provided by the CAA, as amended (42 U.S.C. 7401 et seq. ). Relevant portions of the CAA include, but are not necessarily limited to, sections 181 and 182.

CAA section 107(d) provides that when the EPA establishes or revises a NAAQS, the agency must designate areas of the country as nonattainment, attainment, or unclassifiable based on whether an area is not meeting (or is contributing to air quality in a nearby area that is not meeting) the NAAQS, meeting the NAAQS, or cannot be classified as meeting or not meeting the NAAQS, respectively. Subpart 2 of part D of title I of the CAA governs the classification, State planning, and emissions control requirements for any areas designated as nonattainment for a revised primary ozone NAAQS. In particular, CAA section 181(a)(1) requires each area designated as nonattainment for a revised ozone NAAQS to be classified at the same time as the area is designated based on the extent of the ozone problem in the area (as determined based on the area's DV). Classifications for ozone nonattainment areas are “Marginal,” “Moderate,” “Serious,” “Severe,” and “Extreme,” in order of stringency. CAA section 182 provides the specific attainment planning and additional requirements that apply to each ozone nonattainment area based on its classification.

Section 181(b)(2)(A) of the CAA requires that within 6 months following the applicable attainment date, EPA shall determine whether an ozone nonattainment area attained the ozone standard based on the area's DV as of that date. Under CAA section 181(a)(5) as interpreted by EPA in 40 CFR 51.1307, upon application by any State, EPA may grant a 1-year extension to the attainment date when certain criteria are met. One criterion for a first attainment date extension is that an area's fourth highest daily maximum 8-hour value for the attainment year must not exceed the level of the standard.

In the event an area fails to attain the ozone NAAQS by the applicable attainment date and is not granted a 1-year attainment date extension, CAA section 181(b)(2)(A) requires the EPA to make the determination that an ozone nonattainment area failed to attain the ozone standard by the applicable attainment date, and requires the area to be reclassified by operation of law to the higher of: (1) The next higher classification for the area, or (2) the classification applicable to the area's DV as of the determination of failure to attain. 2 Section 181(b)(2)(B) of the CAA requires EPA to publish the determination of failure to attain and accompanying reclassification in the Federal Register no later than 6 months after the attainment date, which in the case of the Moderate nonattainment areas considered in this determination is February 3, 2025.

Once an area is reclassified, each State that contains a reclassified area is required to submit certain SIP revisions in accordance with its more stringent classification. The SIP revisions are intended to, among other things, demonstrate how the area will attain the NAAQS as expeditiously as practicable, but no later than August 3, 2027, the Serious area attainment date for the 2015 ozone NAAQS. Per CAA section 182(i), a State with a reclassified ozone nonattainment area must submit the applicable attainment plan requirements “according to the schedules prescribed in connection with such requirements” in CAA section 182(c) for Serious areas, but EPA “may adjust applicable deadlines (other than attainment dates) to the extent such adjustment is necessary or appropriate to assure consistency among the required submissions.” EPA is addressing the SIP revision and implementation deadlines for newly reclassified Serious areas, as well as the continued applicability of Moderate area requirements that these areas may not yet have met, in a separate rulemaking.

The level of the 2015 ozone NAAQS is 0.070 ppm. 3 Under EPA regulations at 40 CFR part 50, appendix U, the 2015 ozone NAAQS is attained at a site when the 3-year average of the annual fourth highest daily maximum 8-hour average ambient ozone concentration ( i.e., DV) does not exceed 0.070 ppm. When the DV does not exceed 0.070 ppm at each ambient air quality monitoring site within the area, the area is deemed to be attaining the ozone NAAQS. Each area's DV is determined by the highest DV among monitors with valid DVs. 4 The data handling convention in appendix P dictates that concentrations shall be reported in “ppm” to the third decimal place, with additional digits to the right being truncated. Thus, a computed 3-year average ozone concentration of 0.071 ppm is greater than 0.070 ppm and would exceed the standard, but a computed 3-year average ozone concentration of 0.0709 ppm is truncated to 0.070 ppm and attains the 2015 ozone NAAQS.

EPA's determination of attainment is based upon hourly ozone concentration data for calendar years 2021, 2022 and 2023 that have been collected and quality-assured in accordance with 40 CFR part 58 and reported to EPA's Air Quality System (AQS) database. 5

State and local monitoring network plans are subject to approval by EPA on an annual basis and any interim modifications to those plans must also be approved by EPA. 6 The annual monitoring network plan process is provided in 40 CFR 58.10 and the requirements governing system modifications and monitor discontinuations are laid out in 40 CFR 58.14. Where State or local agencies seek to modify the ambient air quality monitoring networks by discontinuing a monitor station, EPA may approve such modifications subject to the criteria established in 40 CFR 58.14(c). EPA may not approve such discontinuation if doing so would compromise data collection needed for implementation of a NAAQS. If a monitor has been discontinued subject to 40 CFR 58.14 such that the discontinuation results in insufficient data to calculate a valid DV according to appendix U to 40 CFR part 50, EPA will determine the applicable area's attainment status based on the remaining monitors in the area.

EPA is determining that the eight Moderate nonattainment areas addressed in this action failed to attain the 2015 ozone NAAQS by the attainment date of August 3, 2024. The eight areas are: Allegan County, MI; Berrien County, MI; Chicago, IL-IN-WI; Cleveland, OH; Milwaukee, WI; Muskegon County, MI; Sheboygan County, WI; and the Illinois portion of the St. Louis, MO-IL area. As shown in Table 1, at least one monitor in each of these areas had a 2021-2023 DV greater than 0.070 ppm. EPA has further determined that these areas did not meet the requirement under section 181(a)(5)(B) and 40 CFR 51.1307 necessary to grant a 1-year extension of the attainment date, because at least one monitor in each area had a 2023 fourth highest daily maximum 8-hour average that was greater than 0.070 ppm. Table 2 through Table 9 show the annual fourth highest daily maximum 8-hour average ozone concentration and 2021-2023 DV for each monitor in the eight areas.

The EPA is required by Clean Air Act (CAA) section 107(d) to designate all areas throughout the nation as attaining or not attaining the NAAQS within two years of the promulgation of any new or revised NAAQS. Pursuant to CAA section 107(d), the EPA must designate as “nonattainment” those areas that violate the NAAQS and those nearby areas that contribute to violations. Once an area has been designated, the EPA Administrator, under CAA section 107(d)(3), may at any time notify a state that a designation should be revised.

Under section 109 of the CAA, the EPA has established primary and secondary NAAQS for certain pervasive air pollutants and conducts periodic reviews of the NAAQS to determine whether they should be revised or whether new NAAQS should be established. The primary NAAQS represent ambient air quality standards, the attainment and maintenance of which the EPA has determined, including a margin of safety, are requisite to protect the public health. The secondary NAAQS represent ambient air quality standards, the attainment and maintenance of which the EPA has determined are requisite to protect the public welfare from any known or anticipated adverse effects associated with the presence of such air pollutant in the ambient air.

On June 22, 2010 (75 FR 35520), the EPA finalized the revision of the 1-hour primary SO 2 NAAQS, codified at 40 Code of Federal Regulations (CFR) 50.17, which became effective on August 23, 2010 (hereafter referred to as the 2010 SO 2 NAAQS). The 2010 SO 2 NAAQS is met at an ambient air quality monitoring site (or in the case of dispersion modeling, at an ambient air quality receptor location) when the 3-year average of the annual 99th percentile of daily maximum 1-hour average concentrations is less than or equal to 75 parts per billion (ppb), as determined in accordance with appendix T of 40 CFR part 50. 40 CFR 50.17(a) and (b).

The EPA was required to designate areas throughout the country for the 2010 SO 2 NAAQS by June 3, 2012. The EPA invoked a 1-year extension of the deadline to designate areas for the 2010 SO 2 NAAQS, as provided for under CAA section 107, after which the Agency completed an initial round of SO 2 designations for certain areas of the country on August 5, 2013 (referred to as “Round 1”). 1 In Round 1, the EPA designated Indiana County, Pennsylvania and a portion of Armstrong County, Pennsylvania as nonattainment (hereafter referred collectively as the “Indiana Area”). On January 9, 2018, 2 in a subsequent round of designations for the 2010 SO 2 NAAQS, Westmoreland County, Pennsylvania was designated as attainment/unclassifiable, and Cambria County, Pennsylvania was designated as unclassifiable.

In 2018, during the public comment period for the proposed approval of the SO 2 attainment SIP for the Indiana Area (83 FR 32606, July 13, 2018), the Sierra Club submitted a modeling analysis which claimed to also show violations of the SO 2 NAAQS within portions of Westmoreland and Cambria counties due to SO 2 emissions from sources located within the Indiana Area. 3 In 2022, during the public comment period for the proposed partial disapproval and partial approval of the Indiana Area's attainment SIP (87 FR 15166, March 17, 2022), the EPA received additional dispersion modeling from the Sierra Club, and from Keystone-Conemaugh Projects, LLC (KEY-CON), 4 focused on the Westmoreland and Cambria areas. The EPA also conducted its own modeling of those areas. Based on review of all modeling analyses, the EPA made the determination that there are modeled SO 2 NAAQS violations outside of the existing Indiana Area, in portions of Westmoreland and Cambria counties, and accordingly notified the Governor of Pennsylvania in a letter dated February 17, 2023, of our intent to redesignate portions of Westmoreland and Cambria counties as nonattainment for the 2010 1-hour primary SO 2 NAAQS, consistent with CAA section 107(d)(3)(A). 5 On June 22, 2023, Acting Secretary for the Pennsylvania Department of Environmental Protection (PA DEP), Richard Negrin, responded to the EPA's letter but did not specify whether the Commonwealth agreed or disagreed with the EPA's determination to redesignate portions of Westmoreland and Cambria counties as nonattainment for the 2010 1-hour primary SO 2 NAAQS. Instead, Pennsylvania's response included several comments questioning certain aspects of the Technical Support Document (TSD) that the EPA had developed and submitted to PA DEP with the February 17, 2023 redesignation letter. The EPA responded to the Commonwealth's comments in a January 2024 response to comments (RTC) document, which is in the docket associated with this action. 6

The EPA is not required under CAA section 107(d)(3) to seek public comment during the redesignations process, but we elected to do so for this area to provide the public with an opportunity to give input for the EPA's consideration before promulgating any final redesignation. The EPA published a NOA for this action in the Federal Register on February 12, 2024 (89 FR 9815). Upon publication of the NOA in the Federal Register , a 45-day public comment period began. This comment period closed on March 28, 2024, and yielded comments from seven commenters. A copy of the EPA's responses to the comments received from the public is also located in the docket for this action.

The 1-hour primary SO 2 standard is violated at an ambient air quality monitoring site (or in the case of dispersion modeling, at an ambient air quality receptor location) when the 3-year average of the annual 99th percentile of the daily maximum 1-hour average concentrations exceeds 75 ppb, as determined in accordance with appendix T of 40 CFR part 50. The EPA also believes that in certain cases, including when SO 2 monitors are lacking, air dispersion modeling is an appropriate tool to determine whether an area is in attainment, as discussed in the EPA's document titled, “SO 2 NAAQS Designations Modeling Technical Assistance Document” (Modeling TAD). 7 The Modeling TAD provides nonbinding recommendations on how to appropriately and sufficiently model ambient air in proximity to an SO 2 emission source to establish air quality data for comparison to the 2010 primary SO 2 NAAQS for the purposes of designations. For a short-term 1-hour standard, dispersion modeling of stationary sources can be the most technically appropriate, efficient, and effective because it accounts for fairly infrequent combinations of meteorological and source operating conditions that can contribute to peak ground-level concentrations of SO 2 . The EPA's Guideline on Air Quality Models, found at appendix W to 40 CFR part 51, provides recommendations on modeling techniques and guidance for estimating pollutant concentrations to assess control strategies and determine emission limits.

Information and data providing the basis for this action are provided in a designations TSD included in the docket for this action  8 and can also be found online at www.epa.gov/sulfur-dioxide-designations/sulfur-dioxide-designations-regulatory-actions. Additionally, other relevant documents and files regarding this SO 2 redesignation, including PA DEP's comments on the EPA's TSD, the EPA's RTC replying to these comments, and public comments are available for review in the public docket for this action. The information can also be reviewed online at www.epa.gov/sulfur-dioxide-designations/sulfur-dioxide-designations-regulatory-actions.

The EPA has issued multiple guidance documents for performing SO 2 designations, the most recent of which is a September 5, 2019 guidance from Peter Tsirigotis, Director, U.S. EPA, Office of Air Quality Planning and Standards, to Regional Air Division Directors, U.S. EPA Regions 1-10. 9 This memorandum supplements, where necessary, prior designations guidance documents on area designations for the 2010 1-hour primary SO 2 NAAQS issued on March 24, 2011, March 20, 2015, and July 22, 2016. The September 2019 memorandum identifies evaluation factors in determining whether areas are in violation of the 2010 SO 2 NAAQS and factors that the EPA intends to assess in determining the boundaries for such areas. These factors include: (1) air quality characterization via ambient monitoring or dispersion modeling results; (2) emissions-related data; (3) meteorology; (4) geography and topography; and (5) jurisdictional boundaries.

The EPA's modeling indicates that portions of Westmoreland and Cambria counties are violating the 2010 1-hour SO 2 NAAQS, and the Agency's detailed evaluation of the modeled violations, contributing sources, and intended area boundaries based on the weight of evidence of the previously identified factors are included in the TSD, which is located in the docket for this action. The EPA's boundaries of the relevant area encompass Lower Yoder Township in Cambria County, Pennsylvania and St. Clair Township, Seward Borough, and New Florence Borough in Westmoreland County, Pennsylvania. 10 A map showing these boundaries is included in the final TSD. 11

The purpose of this final action is to announce and promulgate EPA's area redesignation of a portion of Westmoreland County, Pennsylvania from attainment/unclassifiable to nonattainment and a portion of Cambria County, Pennsylvania from unclassifiable to nonattainment for the 2010 1-hour primary SO 2 NAAQS, creating a new area called the “Cambria-Westmoreland Area.”

The issuance of this final redesignation will require the Commonwealth of Pennsylvania to undertake certain planning requirements to reduce SO 2 concentrations within this newly redesignated nonattainment area, including, but not limited to, the requirement to submit within 18 months of redesignation, a revision to the Pennsylvania SIP that provides for attainment of the 2010 1-hour primary SO 2 NAAQS as expeditiously as practicable, but no later than five years after the effective date of redesignation to nonattainment.

When the EPA establishes a new or revised NAAQS, the CAA requires the EPA to designate all areas of the U.S. as either nonattainment, attainment, or unclassifiable. This action addresses designation determinations for certain areas for the 2010 SO 2 NAAQS. Area designations address environmental justice concerns by ensuring that the public is properly informed about the air quality in an area. In locations where air quality does not meet the NAAQS, the CAA requires relevant state authorities to initiate appropriate air quality management actions to ensure that all those residing, working, attending school, or otherwise present in those areas are protected, regardless of minority and economic status.

Under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011), this action is exempt and, therefore, is not subject to review by the Office of Management and Budget.

This action does not impose an information collection burden under the PRA. This action is a redesignation of portions of two counties to nonattainment and does not contain any information collection activities.

This action is not subject to the RFA. The RFA applies only to rules subject to notice and comment rulemaking requirements under the Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute. Section 107(d)(2)(B) of the CAA explicitly provides that designations are exempt from the notice-and-comment provisions of the APA. In addition, designations under CAA section 107(d) are not among the list of actions that are subject to the notice-and-comment rulemaking requirements of CAA section 307(d).

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

This action also does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. The division of responsibility between the Federal Government and the states for purposes of implementing the NAAQS is established under the CAA.

This action does not have tribal implications. It will neither impose substantial direct compliance costs on Federally recognized tribal governments, nor preempt tribal law. Thus, Executive Order 13175 does not apply to this action.

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

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

This rule does not involve technical standards.

Executive Order 12898 (59 FR 7629, February 16, 1994) directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations (people of color and/or Indigenous peoples) and low-income populations. The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). This action, on which the EPA offered public notice and comment, changes the air quality designation of an area and triggers an obligation on the part of the Commonwealth to develop an implementation plan to improve air quality in the area so that it meets the 2010 SO 2 NAAQS. A forthcoming implementation plan by the Commonwealth will also be available for public notice and comment.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 18, 2025. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See CAA section 307(b)(2).

The statutory authority for this action is provided by 42 U.S.C. 7401, et seq.

For the reasons stated in the preamble the Environmental Protection Agency amends title 40 CFR part 81 as follows:

Subpart C—Section 107 Attainment Status Designations

This final rule is organized as follows:

Federal water quality standards (WQS) promulgated by the EPA in this rule will be the applicable WQS for certain waters in California for Clean Water Act (CWA) purposes after the effective date of this rule. Specifically, the chronic freshwater selenium criterion in the final rule will apply to California waters in a manner consistent with the California Toxics Rule (CTR) and the EPA's proposed rulemaking for this action (83 FR 64059, December 13, 2018). The freshwater and saltwater aquatic life criteria listed in the CTR apply as follows: (1) the freshwater criteria apply at salinities of 1 part per thousand and below at locations where this occurs 95% or more of the time; (2) saltwater criteria apply at salinities of 10 parts per thousand and above at locations where this occurs 95% or more of the time; and (3) the more stringent of the two apply at salinities between 1 and 10 parts per thousand. As a result, many estuarine waters will be covered by this rule.

WQS serve as the basis for CWA programs, such as National Pollutant Discharge Elimination System (NPDES) permitting and identifying impaired waters under CWA section 303(d). Categories and entities that could potentially be affected by this rule include the following:

This table is not exhaustive but, rather, it provides a guide that identifies entities that could be affected by this action. If you have questions regarding the effect of this action on a particular entity, please consult the person listed in the FOR FURTHER INFORMATION CONTACT section.

On November 29, 2018, the Administrator of the EPA signed a proposed rulemaking to establish a selenium water quality criterion applicable to California that protects aquatic life and aquatic-dependent wildlife in certain waters of California. The proposal was published in the Federal Register at 83 FR 64059 on December 13, 2018. For the proposed rulemaking, the EPA provided a 60-day public comment period with a 45-day extension and held two public hearings on March 19 and March 20, 2019, to accept verbal public comments. By the end of the public comment period on March 28, 2019, the EPA received a total of 32 comments on a range of issues submitted by organizations and individuals to the docket for the rule and during the two public hearings.

For the final rule, the EPA carefully considered the public comments and feedback the Agency received on the proposed rulemaking. In relevant sections of the preamble below, the EPA provides brief summaries of certain comments. Some comments addressed issues beyond the scope of this rule. For all the comments the EPA received and the EPA's responses, see the EPA's Response to Comments document in the public docket for this rule: Docket ID No. EPA-HQ-OW-2018-0056.

The CWA establishes the basic structure for regulating pollutant discharges from point sources into the waters of the United States. In the CWA, Congress established the national objective to restore and maintain the chemical, physical, and biological integrity of the Nation's waters. The CWA also sets forth the interim goal of achieving water quality, wherever attainable, that provides for both: (1) the protection and propagation of fish, shellfish, and wildlife; and (2) recreation in and on the water (sections 101(a) and 101(a)(2)). 33 U.S.C. 1251(a), (a)(2). To help achieve these goals, the CWA created two complementary structures for regulating discharges in CWA section 402 NPDES permits: first, technology-based effluent limitations (TBELs) that set a floor for the performance for categories of regulated dischargers; and second, water quality-based effluent limitations (WQBELs) that are established where TBELs are insufficient to meet applicable WQS or site-specific water quality goals. See 33 U.S.C. 1342(a). TBELs in NPDES permits are derived from secondary treatment standards (for publicly owned treatment works), effluent limitations guidelines (CWA sections 301 and 304, 33 U.S.C. 1311 and 1314), new source performance standards (CWA section 306, 33 U.S.C. 1316) promulgated by the EPA, and/or established on a case-by-case basis under section 402(a)(1) of the Act (to the extent that EPA-promulgated effluent limitations are inapplicable). If TBELs are not sufficient to achieve the WQS in the receiving water, the CWA (section 301(b)(1)(c), 33 U.S.C. 1311(b)(1)(c)) and the EPA's NPDES regulation, 40 CFR 122.44(d), require that the permit writer develop more stringent WQBELs.

WQS are the foundation of the water quality-based pollution control programs required by the CWA. Such standards serve as a description of the desired water quality condition for particular waterbodies. In addition, WQS serve as the basis for several CWA programs, including:

• WQBELs in NPDES permits under section 402, 33 U.S.C. 1342;

• Waterbody assessments and establishment of total maximum daily loads (TMDLs) under section 303(d), 33 U.S.C. 1313(d);

• Certifications of Federal licenses and permits under section 401, 33 U.S.C., 1341.

CWA section 303(c) directs states to adopt WQS for their waters subject to the CWA. WQS consist of designated uses of the waters, water quality criteria to protect those uses, and an antidegradation policy to maintain water quality (CWA section 303(c)(2)(A) and (d)(4)(B)). The EPA's regulation at 40 CFR 131.11(a)(1) provides that “[s]uch criteria must be based on sound scientific rationale and must contain sufficient parameters or constituents to protect the designated use [and] [f]or waters with multiple use designations, the criteria shall support the most sensitive use.”

States are required to review applicable WQS at least once every three years and, if appropriate, revise or adopt new WQS (CWA section 303(c)(1) and 40 CFR 131.20). Any new or revised WQS must be submitted to the EPA for review and approval or disapproval (CWA section 303(c)(2)(A) and (c)(3) and 40 CFR 131.20 and 131.21). Under CWA section 303(c)(4)(B), the Administrator is authorized to determine that a new or revised standard is necessary to meet CWA requirements.

Under CWA section 304(a), the EPA is required to periodically publish national water quality criteria recommendations for states to consider when adopting water quality criteria for particular pollutants to meet the CWA section 101(a)(2) goals. In establishing numeric criteria, states should adopt water quality criteria based on the EPA's CWA section 304(a) criteria, section 304(a) criteria modified to reflect site-specific conditions, or other scientifically defensible methods (40 CFR 131.11(b)(1)). CWA section 303(c)(2)(B) requires states to adopt numeric criteria for all toxic pollutants listed pursuant to CWA section 307(a)(1) for which the EPA has published CWA section 304(a) criteria, where the presence or discharge of those pollutants could reasonably be expected to interfere with maintaining designated uses.

The EPA has promulgated selenium water quality criteria for various waterbodies in California. First, in 1992, the EPA promulgated selenium criteria for certain California waters as part of the Water Quality Standards; Establishment of Numeric Criteria for Priority Toxic Pollutants; States' Compliance at 57 FR 60848, December 22, 1992, (hereafter referred to as the National Toxics Rule or NTR), 1 and then again in 2000, as part of the Water Quality Standards; Establishment of Numeric Criteria for Priority Toxic Pollutants for the State of California at 65 FR 31681, May 18, 2000, (hereafter referred to as the California Toxics Rule or CTR). 2 In each case, the EPA promulgated the EPA's recommended aquatic life criteria values at the time. In addition to the NTR and CTR selenium criteria, California has also adopted site-specific acute and chronic selenium criteria (California uses the term “objectives” instead of criteria). The criteria that the EPA previously promulgated for California in the NTR, 3 together with the criteria promulgated in the CTR and California's site-specific objectives, established WQS for priority toxic pollutants for inland surface waters and enclosed bays and estuaries in California.

For a full summary of the applicable selenium criteria covered by the NTR, the CTR, and California site-specific selenium objectives, please refer to the preamble of the EPA's proposed rulemaking for this action, sections II.B and II.C (83 FR 64059, December 13, 2018). For a discussion on the scope of California waters covered by this rule, please see section V. of this preamble.

As required by section 7 of the Endangered Species Act (ESA) (16 U.S.C. 1531 et seq. ), the EPA consulted with the U.S. Fish and Wildlife Service (FWS) and the U.S. National Marine Fisheries Service (NMFS) (collectively, the Services) concerning the EPA's proposed and final CTR. The EPA initiated consultation with the Services in 1994. In March 2000, the Services issued a final Joint Biological Opinion. The final Joint Biological Opinion  4 recorded commitments by the EPA to: (1) withhold promulgation of ( i.e., reserve) the EPA's proposed acute  5 freshwater aquatic life criterion for selenium in the final CTR; (2) revise the national CWA section 304(a) recommended acute and chronic aquatic life criteria for selenium; and (3) later update the acute and chronic aquatic life criteria for California consistent with the revised national CWA section 304(a) recommendations. As a result, in the May 2000 CTR, the EPA finalized the chronic freshwater selenium criterion  6 and the acute and chronic saltwater selenium criteria but did not finalize the acute freshwater selenium criterion.

Section 303(c)(4)(B) of the CWA gives the EPA Administrator authority to promulgate water quality standards for a state where necessary to meet the requirements of CWA section 303. The EPA made an Administrator's determination under section 303(c)(4)(B) of the CWA, included in the 1997 proposed  7 and 2000 final CTR, that numeric criteria are necessary in California to meet the requirements of section 303(c)(2)(B) to protect the State's designated uses. 8 In 2013, two organizations filed a complaint against the EPA in the United States District Court for the Northern District of California. The complaint was based in part on the fact that the EPA had previously determined, in the CTR, that selenium criteria were necessary to implement section 303(c)(2)(B) of the CWA (62 FR 42160, August 5, 1997) and the work to update the reserved freshwater acute selenium criterion from the 2000 CTR had not yet been completed. In 2014, the EPA entered into a consent decree to resolve these claims ( Our Children's Earth Foundation and Ecological Rights Foundation v. U.S. Environmental Protection Agency, et al., 13-cv-2857 (N.D. Cal, August 22, 2014)).

Under the terms of the consent decree, the EPA committed to proposing selenium criteria for California fresh waters covered by the original CTR to protect aquatic life and aquatic-dependent wildlife by November 30, 2018. On November 29, 2018, the EPA satisfied this commitment when the Administrator of the EPA signed the proposed rulemaking to establish a selenium water quality criterion applicable to California that protects aquatic life and aquatic-dependent wildlife in certain waters of California. The consent decree also required that the EPA request to initiation of any necessary ESA section 7(a)(2) consultation with the Services on the proposed selenium criteria no later than nine months after the date the EPA proposed the criteria. The EPA satisfied this commitment by initiating ESA consultation with the Services on the proposed selenium criterion on August 12, 2019.

Further, under the consent decree, the EPA is required to finalize its proposed selenium criteria within six months of the later of the following: (1) the date of the EPA's conclusion (if any) that it will not seek ESA section 7(a)(2) consultation because some or all of the proposed selenium criteria have “no effect” on any listed ESA species or designated critical habitat; (2) the date of written concurrence from the Services with any EPA conclusion that some or all of the proposed selenium criteria are “not likely to adversely affect” listed ESA species or designated critical habitat; or (3) the date of the Services' Biological Opinion(s) concluding any formal consultation on the proposed selenium criteria.

Selenium is a naturally occurring, but relatively rare, element present in sedimentary rocks and soils. It is also present in the atmosphere as methyl derivatives of selenium. There are around 40 known selenium-containing minerals, some of which can have as much as 30% selenium, but all are rare and generally occur together with sulfides of metals such as copper, zinc, and lead. 9 The distribution of organic-enriched sedimentary rocks, black shales, petroleum source rocks, ore deposits, phosphorites, and coals, in which selenium typically co-occurs, is well characterized in the United States. 10 Two major anthropogenic ( i.e., human-caused) activities can cause selenium to become mobilized and introduced into aquatic systems. The first is extracting metals, minerals, and fossil fuels; the second is irrigation of selenium-rich soils. Once inorganic selenium is converted into a bioavailable form ( i.e., a form that can be absorbed into the body following skin contact, ingestion, or inhalation), it enters the food chain and can bioaccumulate ( i.e., can be taken up and retained by an aquatic organism from any surrounding media, e.g., water, food, sediment).

Elevated selenium levels above what is nutritionally required in fish and other wildlife inhibit normal growth and reduce reproductive success through effects that lower embryo survival, most notably teratogenesis ( i.e., embryo/larval deformities) (see 2021 Revision to: Final Aquatic Life Ambient Water Quality Criteria for Selenium—Freshwater 2016, US EPA, Office of Water, EPA 822-R-21-006, August 2021). The deformities associated with exposures to elevated selenium in fish may include skeletal, craniofacial, and fin deformities, and various forms of edema that result in mortality. Elevated selenium exposure in birds can reduce reproductive success including decreased fertility, reduced egg hatchability (embryo mortality), and increased incidence of deformities in embryos.

Scientific studies  11 indicate that selenium toxicity to aquatic life and aquatic-dependent wildlife is driven by diet ( i.e., the consumption of selenium-contaminated prey) rather than by direct exposure to dissolved selenium in the water column. Unlike other bioaccumulative contaminants, such as mercury, the single largest step in selenium accumulation in aquatic environments occurs at the base of the food web when algae and other particulate material take up selenium from water. The vulnerability of a species to selenium toxicity is determined by a number of factors, in addition to the amount of contaminated prey consumed. Those factors include a species' sensitivity to selenium, its population status, and the duration, timing, and life stage of exposure. In addition, the hydrologic conditions and water chemistry of a waterbody affect bioaccumulation; in general, slow-moving, calm waters or lentic waters enhance the production of bioavailable forms of selenium (selenite), while faster-moving waters or lotic waters limit selenium uptake by aquatic life and aquatic-dependent wildlife given the rapid movement and predominant form of selenium (selenate). The EPA considered these and other factors in determining the selenium criterion for California.

In 2016, the EPA published a revised national CWA section 304(a) recommended chronic freshwater aquatic life criterion for selenium to better account for bioaccumulation through the food chain in different ecosystems, and published an erratum in 2021, 2021 Revision to: Final Aquatic Life Ambient Water Quality Criterion for Selenium—Freshwater 2016, US EPA, Office of Water, EPA 822-R-21-006, August 2021. 12 For purposes of clarity in this preamble, all subsequent references to the EPA's current national CWA section 304(a) recommended chronic freshwater criterion for selenium refers to its 2021 published version. The recommended chronic freshwater criterion is comprised of four criterion elements, two of which are fish tissue concentrations and two of which are water column concentrations. The recommended elements are: (1) a fish egg-ovary element of 15.1 milligram per kilogram (mg/kg) dry weight; (2) a fish whole-body element of 8.5 mg/kg dry weight or a muscle element of 11.3 mg/kg dry weight; (3) a water column element of 3.1 µg/L in lotic aquatic systems and 1.5 µg/L in lentic aquatic systems; and (4) a water column intermittent exposure element derived from the chronic water column element to account for potential chronic effects from short-term exposures (one value for lentic and one value for lotic aquatic systems).

As stated previously, on November 29, 2018, the EPA Administrator signed the proposed rulemaking to establish a selenium water quality criterion that protects aquatic life and aquatic-dependent wildlife in certain fresh waters of California. The EPA proposed its recommended 2016 CWA section 304(a) selenium criterion for freshwater with two modifications to the criterion. First, the EPA proposed adding a bird tissue criterion element derived to protect aquatic-dependent wildlife to the EPA's national CWA section 304(a) selenium criterion. Second, the EPA proposed replacing the EPA's national CWA section 304(a) selenium monthly average exposure water column (lentic or lotic) criterion element (referred to as the default water column criterion element) with a performance-based approach (PBA) for translating a tissue criterion element into a corresponding water column criterion element on a site-specific basis and took comment on whether to keep the default water column criterion element, in addition to the PBA, in the final rule.

In this rule, the EPA considered the methodology and information used to derive the current national CWA section 304(a) recommended selenium criterion, additional information specific to aquatic-dependent wildlife in California, and the public comments and feedback the EPA received on the proposed rulemaking in order to ensure broad protection for both aquatic and aquatic-dependent species. The final freshwater chronic selenium criterion for certain waters in California adds a bird tissue criterion element to the national CWA section 304(a) selenium criterion, consistent with the proposed rulemaking, in addition to the PBA. The EPA also included the default water column criterion element from the EPA's national CWA section 304(a) selenium criterion, in addition to the PBA in the final rule. The PBA will allow the State to develop a site-specific water column element to be used instead of the default water column criterion element. For a further discussion of the EPA's final chronic freshwater selenium criterion and what the EPA considered in finalizing this rule, see section III.C of this preamble and also refer to the EPA's Response to Comments document in the public docket for this rule.

As mentioned previously, the chronic freshwater selenium criterion in this final rule will apply to California waters in a manner consistent with the CTR and the EPA's proposed rulemaking for this action (83 FR 64059, December 13, 2018).

The promulgated criterion establishes levels of selenium that protect California's aquatic life and aquatic-dependent wildlife designated uses (California uses the term “beneficial uses” instead of designated uses) for certain waters of California consistent with California's implementation of the CTR. California's applicable designated (beneficial) uses for the protection of aquatic life and aquatic-dependent wildlife are listed in table 1 of this preamble.

As previously noted, in the 1997 proposed and 2000 final CTR, the EPA Administrator determined under CWA section 303(c)(4)(B) that selenium criteria were necessary in California. In the 1997 proposed CTR, the EPA proposed both acute and chronic freshwater selenium criteria. In the 2000 final CTR, the EPA promulgated a chronic freshwater selenium criterion; withheld promulgation of ( i.e., reserved) an acute freshwater selenium criterion; and committed to revising the national CWA section 304(a) recommended acute and chronic aquatic life criteria for selenium and later updating the acute and chronic aquatic life criteria for California consistent with the revised national CWA section 304(a) recommendations. The Services incorporated the EPA's commitments as Terms and Conditions in the final Joint Biological Opinion for the CTR.

In November 2018, the EPA proposed a revised chronic selenium criterion based on the EPA's current national CWA section 304(a) recommended criterion for selenium, which only includes a chronic criterion. The EPA's current national CWA section 304(a) recommendation does not include a separate acute criterion because selenium is bioaccumulative and toxicity primarily occurs through dietary exposure. Although selenium may cause acute toxicity at high concentrations, the most harmful effect on aquatic organisms is due to its bioaccumulative properties; these chronic effects occur at lower concentrations of selenium in aquatic organisms than acute effects. In addition, as discussed further in section III.C of this preamble, application of the intermittent exposure criterion element (that the EPA is promulgating as part of the chronic criterion) to single day, high exposure events will provide protection from the most important selenium toxicity effect, reproductive toxicity, by protecting against selenium bioaccumulation in the aquatic ecosystem resulting from short-term, high exposure events. Since the time of the EPA's proposed rulemaking in November 2018, the EPA is not aware of any significant scientific updates to alter the scientific basis underlying the EPA's current national CWA section 304(a) recommended freshwater chronic selenium criterion. As a result, the EPA is not including a separate freshwater acute selenium criterion.

Accordingly, promulgation of the freshwater chronic selenium criterion in this rule completes the EPA's action pursuant to the Administrator's Determination as it pertains to selenium criteria, as provided in the 1997 and 2000 preambles to the CTR.

In addition, this promulgation satisfies the Services' Term and Condition included in the final Joint Biological Opinion for the CTR to update the selenium criterion for California consistent with the current national CWA section 304(a) recommendations (see section II.C. of this preamble). For more information about the ESA consultation completed for this final rule, see section IV. of this preamble.

In this final rule, the EPA is promulgating its current national CWA section 304(a) recommended chronic selenium criterion for certain fresh waters in California (including the default water column criterion element), with the addition of a bird tissue criterion element and a performance-based approach (PBA)  14 for translating a tissue criterion element into a corresponding water column criterion element on a site-specific basis. In its proposed rulemaking, the EPA solicited comment on whether to replace the default water column criterion element from the Agency's 2016 CWA section 304(a) selenium criterion with the PBA, replace the PBA with the default water column criterion element from the Agency's 2016 CWA section 304(a) selenium criterion, or include both. As discussed further in this section and in the EPA's Response to Comments document in the public docket for this rule, the EPA is including both the default water column criterion element and the PBA in its promulgation of the chronic criterion; a site-specific water column value developed using the PBA may be used in place of the default (lentic or lotic) water column criterion element.

The final freshwater chronic selenium criterion for California is depicted in table 2 of this preamble.

In the proposed rulemaking, the EPA solicited comment on two potential criteria structures: (1) one criterion that protects both the applicable aquatic life and aquatic-dependent wildlife designated uses; and (2) two separate criteria with one intended to protect the applicable aquatic life designated uses and one intended to protect the applicable aquatic-dependent wildlife designated uses. Most commenters requested that the EPA keep the proposed option of one criterion.

After considering comments, the EPA is finalizing the rule as proposed, meaning that one criterion (with multiple criterion elements as shown in table 2 of this preamble) will be used to protect both aquatic life and aquatic-dependent wildlife designated uses in the waters covered by this rule. The one criterion consists of the following criterion elements: fish egg-ovary tissue, fish muscle or whole-body tissue, bird egg tissue, default water column (lentic and lotic), intermittent exposure water column, and a PBA for translating the tissue criterion elements into corresponding water column criterion elements on a site-specific basis.

The tissue criterion elements consist of (1) a fish egg-ovary criterion element of 15.1 mg/kg dry weight, (2) a fish whole-body criterion element of 8.5 mg/kg dry weight or a fish muscle criterion element of 11.3 mg/kg dry weight, and (3) a bird egg criterion element of 11.2 mg/kg dry weight. The fish egg-ovary tissue (from which all other fish tissue elements were derived) and bird egg tissue criterion elements were developed to protect aquatic and aquatic-dependent wildlife populations from impacts caused by selenium: they reflect biological uptake of selenium through diet, which is the predominant pathway for selenium toxicity, and are most predictive of the observed biological endpoint of concern, reproductive toxicity.

The water column criterion elements consist of (1) the default water column criterion element for lentic waters, 1.5 µg/L, or for lotic waters, 3.1 µg/L and (2) the intermittent exposure water column criterion element. In addition to the default water column criterion element, EPA is also promulgating the PBA Method for Translating Selenium Tissue Criterion Elements into Site-specific Water Column Criterion Elements for California, Version 2, December 2024, which is available in the docket for this rulemaking and incorporated by reference as part of this rule.

The chronic selenium criterion applies to the entire aquatic community, including aquatic-dependent wildlife. Based on the analysis in the accompanying Technical Support Document (TSD) to this rule ( FINAL Aquatic Life and Aquatic-Dependent Wildlife Selenium Water Quality Criterion for Freshwaters of California (December 2024) ) and the EPA's previous work ( 2021 Revision to: Final Aquatic Life Ambient Water Quality Criterion for Selenium—Freshwater 2016, US EPA, Office of Water, EPA 822-R-21-006, August 2021), as well as currently available data, fish and birds are considered the most sensitive aquatic and aquatic-dependent taxa to selenium effects, respectively.

The available data indicate that applying the criterion in table 2 of this preamble would protect aquatic life and aquatic-dependent wildlife from the toxic effects of selenium, recognizing that the bird tissue criterion element is independently applicable from and equivalent to the fish tissue criterion elements; the fish egg-ovary criterion element supersedes all other fish tissue elements; the fish tissue criterion elements (egg-ovary, whole-body, and/or muscle) supersede water column criterion elements for aquatic life when fish tissue is measured; and the bird tissue criterion element supersedes water column criterion elements for aquatic-dependent wildlife when bird egg tissue is measured. This hierarchy reflects the fact that fish and bird tissue concentrations provide the most robust and direct information on potential selenium effects in fish and birds. See section III.D Implementation of the Final Chronic Selenium Criterion in California of this preamble for the discussion regarding implementation of the final chronic selenium criterion and one exception to the hierarchy described above when selenium inputs are increasing.

The EPA is promulgating the following chronic criterion in new paragraph (b)(1)(i) of 40 CFR 131.38. The EPA is also making revisions to footnote q in the criteria table in paragraph (b)(1) and clarifying edits regarding the applicability of this criterion in paragraphs (c)(3)(ii) and (iii). The EPA is not amending or revising the contents of the table in (b)(1) and language in 40 CFR 131.38, except as specified in the preceding two sentences.

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 174 through the Office of the Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-174.

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-2022-0231, 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 February 18, 2025. 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-2022-0231, 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/where-send-comments-epa-dockets.

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 19, 2023 (88 FR 87733) (FRL-10579-11-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 3F9076) by Bayer CropScience LP, 800 N. Lindbergh Blvd., St. Louis, Missouri 63167. The petition requested that 40 CFR part 174 be amended by establishing an exemption from the requirement of a tolerance for residues of the plant-incorporated protectants (PIPs) Brevibacillus laterosporus Mpp75Aa1.1 and Bacillus thuringienisis Vpb4Da2 in or on corn. That document referenced a summary of the petition prepared by the petitioner Bayer Crop Science LP, which is available in the docket at https://www.regulations.gov. There was one comment 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 it 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 evaluated the available toxicity and exposure data on Mpp75Aa1.1 and Vpb4Da2 proteins and considered their validity, completeness, and reliability, as well as 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. A summary of the data upon which EPA relied and its risk assessment based on those data can be found within the document entitled “Review of the Application for an Experimental Use Permit to Test MON 95275 Corn (OECD Unique Identifier MON-95275-7) Expressing Transgenic Plant-Incorporated Protectants Mpp75Aa1.1, Vpb4Da2, and Double Stranded RNA DvSnf7.1 and the Genetic Material Necessary for their Production (Vector PV-ZMIR525664)” (hereafter Human Health Risk Assessment). This document, as well as other relevant information, is available in the docket for this action EPA-HQ-OPP-2022-0231.

Mpp75Aa1.1 is a modified protein derived from the bacterium Brevibacillus laterosporus and is active against certain coleopteran pests of corn. Available data demonstrated that, with regard to humans, the Mpp75Aa1.1 protein does not pose a toxic or allergenic risk. An acute oral toxicity study using purified Mpp75Aa1.1 protein shows that the protein is not toxic to mammals via the oral route of exposure at levels well above those that are reasonably anticipated through normal dietary consumption of the crop. In addition, a bioinformatics analysis of the primary protein sequence did not identify any significant homologies of the Mpp75Aa1.1 protein to known mammalian toxins. Likewise, the potential for allergenicity is low because: (1) the bacterial source of the Mpp75Aa1.1 protein, Brevibacillus laterosporus, is ubiquitous in the environment, which implies widespread human and animal exposure, and a scientific literature search of the bacterium did not indicate any allergenic history; (2) bioinformatic analyses indicate no biologically relevant similarity between the Mpp75Aa1.1 protein and any known allergens; (3) the Mpp75Aa1.1 protein degrades rapidly when exposed to digestive enzymes (gastric proteases) present in the human gastrointestinal tract; (4) the Mpp75Aa1.1 protein shows loss of function under high temperatures (≥75 °C), indicating that it is heat labile and will likely denature in the course of normal thermal treatment during food preparation; and (5) the Mpp75Aa1.1 protein is not glycosylated, which further reduces its allergenicity potential. Glycosylation is an enzymatic post-translational process in which carbohydrates (glycans) link to proteins, creating structures which could lead to an immune response in humans.

The most likely route of exposure to this plant-incorporated protectant is dietary, via products produced from corn expressing the Mpp75Aa1.1 protein. Oral exposure from ingestion of drinking water is unlikely because the Mpp75Aa1.1 protein is present at very low levels within the plant cells, and the amounts likely to enter the water column from leaves, pollen or plant detritus are low. Further, if Mpp75Aa1.1 protein were to enter the water column, it is expected to break down rapidly through natural processes ( e.g., microbial or UV degradation) or normal communal water-treatment procedures. Even if there may be dietary exposure to residues of the Mpp75Aa1.1 protein, such exposure presents no concern for adverse effects based on the available toxicity and allergenicity analysis mentioned above.

Non-dietary non-occupational exposure via dermal or ocular routes is not likely since the Mpp75Aa1.1 protein is contained within plant cells. The most likely non-dietary route of exposure to the Mpp75Aa1.1 protein may be through inhalation of corn pollen. However, exposure to the Mpp75Aa1.1 protein through this route of exposure is expected to be negligible for several reasons: (1) its presence in pollen was demonstrated to be very low (below the limit of quantification), and (2) corn pollen is not respirable, as it consists of spherical particles ranging in size from 80 to 125 μm, in contrast with respirable particles that are less than 10 μm. Even if inhalation of dust-like particles were to occur, the Mpp75Aa1.1 protein is contained within plant cells, which essentially eliminates pulmonary exposure to the proteins. Further, as described above, such exposure would not be expected to present any risk due to the lack of toxicity or allergenicity observed for the Mpp75Aa1.1 protein. These findings are discussed in more detail in the Human Health Risk Assessment.

Vpb4Da2 is derived from the bacterium Bacillus thuringiensis ( Bt ) and is active against certain coleopteran pests of corn. Available data demonstrated that, with regard to humans, the Vpb4Da2 protein does not pose a toxic or allergenic risk. An acute oral toxicity study using purified Vpb4Da2 protein shows that the protein is not toxic to mammals via the oral route of exposure at levels well above those that are reasonably anticipated through normal dietary consumption of the crop. In addition, a bioinformatics analysis of the primary protein sequence did not identify any significant homologies of the Vpb4Da2 protein to known mammalian toxins. Likewise, the potential for allergenicity is low because: (1) the bacterial source of the Vpb4Da2 protein, Bacillus thuringiensis, has a long history of safe use, including use as a pesticide, and is not considered to be a source of allergenic proteins; (2) bioinformatic analyses indicate no biologically relevant similarity between the Vpb4Da2 protein and any known allergens; (3) the Vpb4Da2 protein degrades rapidly when exposed to digestive enzymes (gastric proteases) present in the human gastrointestinal tract; (4) the Vpb4Da2 protein shows loss of function under high temperatures (≥55 °C), indicating that it is heat labile and will likely denature in the course of normal thermal treatment during food preparation; and (5) the Vpb4Da2 protein is not glycosylated, which further reduces its allergenicity potential. Glycosylation is an enzymatic post-translational process in which carbohydrates (glycans) link to proteins, creating structures which could lead to an immune response in humans.

The most likely route of exposure to this plant-incorporated protectant is dietary, via products produced from corn expressing the protein. Oral exposure from ingestion of drinking water is unlikely because the Vpb4Da2 protein is present at very low levels within the plant cells and the amounts likely to enter the water column from leaves, pollen or plant detritus are low. Further, if protein were to enter the water column, it is expected to break down rapidly through natural processes ( e.g., microbial or UV degradation) or normal communal water-treatment procedures. Even if there may be dietary exposure to residues of the Vpb4Da2 protein, such exposure presents no concern for adverse effects based on the toxicity and allergenicity discussion above.

Non-dietary non-occupational exposure via dermal or ocular routes is not likely since the Vpb4Da2 protein is contained within plant cells. The most likely non-dietary route of exposure to the Vpb4Da2 protein may be through inhalation of corn pollen. However, exposure to the Vpb4Da2 protein through this route of exposure is expected to be negligible for several reasons: (1) its presence in pollen was demonstrated to be very low (below the limit of quantification), and (2) corn pollen is not respirable, as it consists of spherical particles ranging in size from 80 to 125 μm, in contrast with respirable particles that are less than 10 μm. Even if inhalation of dust-like particles were to occur, the Vpb4Da2 protein is contained within plant cells, which essentially eliminates pulmonary exposure to the proteins. Further, as described above, such exposure would not be expected to present any risk due to the lack of toxicity or allergenicity observed for the Vpb4Da2 protein These findings are discussed in more detail in the Human Health Risk Assessment.

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.” No risk of cumulative toxicity or effects from the Mpp75Aa1.1 protein has been identified as no toxicity or allergenicity has been shown for this protein in the submitted studies. Therefore, EPA has concluded that the Mpp75Aa1.1 protein does not have a common mechanism of toxicity with other substances. Similarly, no risk of cumulative toxicity or effects from the Vpb4Da2 protein has been identified as no toxicity or allergenicity has been shown for this protein in the submitted studies. Therefore, EPA has concluded that the Vpb4Da2 protein does not have a common mechanism of toxicity with other substances.

Although FFDCA section 408(b)(2)(C) provides for an additional tenfold margin of safety for infants and children in the case of threshold effects, EPA has determined that there are no such effects due to the lack of toxicity of the Mpp75Aa1.1 protein. As a result, an additional margin of safety for the protection of infants and children is unnecessary. Similarly, EPA has determined that there are no such effects due to the lack of toxicity of the Vpb4Da2 protein. As a result, an additional margin of safety for the protection of infants and children is unnecessary.

Based upon its evaluation described above and in the Human Health Risk Assessment, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of the Mpp75Aa1.1 protein derived from the bacterium Brevibacillus laterosporus. Therefore, an exemption from the requirement of a tolerance is established for residues of the Mpp75Aa1.1 protein in or on the food and feed commodities of corn: corn, field; corn, sweet; and corn, pop when used as a plant-incorporated protectant in corn.

Similarly, based upon its evaluation described above and in the Human Health Risk Assessment, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of the Vpb4Da2 protein derived from the bacterium Bacillus thuringiensis ( Bt ). Therefore, an exemption from the requirement of a tolerance is established for residues of the Vpb4Da2 protein in or on the food and feed commodities of corn: corn, field; corn, sweet; and corn, pop when used as a plant-incorporated protectant in corn.

EPA has determined that validated Enzyme-Linked Immunosorbent Assays (ELISA) are available for the detection of Mpp75Aa1.1 and Vpb4Da2 proteins. These assays have been demonstrated to reliably detect the levels of the Mpp75Aa1.1 and Vpb4Da2 proteins in the tissues of corn.

One comment was received during the public comment period for the notice of filing. The commentor provided general objections to EPA establishing exemptions from tolerances for pesticides but did not provide any specific or substantive objections to the petition to exempt the Mpp75Aa1.1 and Vpb4Da2 proteins when used as plant-incorporated protectants. Based on its review of the data and other information submitted in support of the tolerance exemption petition (as described above in Unit III.A), EPA has determined that a tolerance exemption for Mpp75Aa1.1 and Vpb4Da2 proteins, when used as plant-incorporated protectants, is safe under the FFDCA. Therefore, EPA is establishing an exemption from the requirement of a tolerance for residues of Mpp75Aa1.1 and Vpb4Da2 proteins in or on the food and feed commodities of corn.

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

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemptions from the requirement of a 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 final rule is organized as follows:

Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Response Act), the HHS Secretary must, by regulation, establish and maintain a list of biological agents and toxins that have the potential to pose a severe threat to public health and safety (42 U.S.C. 262a(a)(1)). In determining whether to include a biological agent or toxin on the list, the Bioterrorism Response Act requires that the HHS Secretary consider the following criteria:

• the effect on human health of exposure to an agent or toxin;

• the degree of contagiousness of the agent and the methods by which the agent or toxin is transferred to humans;

• the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent illnesses resulting from an agent or toxin; and

• any other criteria, including the needs of children and other vulnerable populations, that the HHS Secretary considers appropriate (42 U.S.C. 262a(a)(1)(B)).

Under 42 U.S.C. 262a(a)(2), the HHS Secretary must review and republish the list of HHS select agents and toxins at least biennially.

In the preparation of this rulemaking, HHS/CDC considered the statutory criteria and evaluated each agent and toxin based on the following:

• Effect on human health:

○ the degree of pathogenicity (ability of an organism to cause disease);

○ long-term health effects;

○ severity of illness;

○ case fatality rate;

○ status of host immunity ( e.g., whether an individual has already been exposed to the agent and generated an immune response);

○ vulnerability of special populations;

• Degree of contagiousness:

○ dissemination efficacy;

○ aerosol stability;

○ rate of transmission;

• Availability and effectiveness of pharmacotherapies:

○ available treatment;

• Other Criteria:

○ decontamination and restoration (the extent remediation efforts are needed due to agent persistence in the environment and population);

○ matrix stability;

○ ease of production;

○ ability to genetically manipulate or alter;

○ the burden or impact on the health care system.

The Federal Select Agent Program (FSAP) is the collaboration of the CDC, Division of Regulatory Science and Compliance (previously known as the Division of Select Agents and Toxins), and the USDA Animal and Plant Health Inspection Service (APHIS), Division of Agricultural Select Agents and Toxins. These two agencies administer the HHS and USDA select agent and toxin regulations and coordinate Federal oversight of select agents and toxins in a manner to minimize the administrative burden on the regulated community.

The list of HHS select agents and toxins is divided into two sections—agents and toxins regulated solely by HHS and agents that are regulated by both HHS and USDA. The biological agents and toxins listed in 42 CFR 73.3 (HHS select agents and toxins) have the potential to pose a severe threat to human health and safety and are regulated only by HHS. The biological agents listed in § 73.4 (overlap select agents and toxins) have the potential to pose a severe threat to human health and safety, as determined by HHS, and a severe threat to animals and animal products, as determined by the USDA, pursuant to USDA's authority under the Agriculture Bioterrorism Protection Act of 2002 (7 U.S.C. 8401). Accordingly, these biological agents are jointly regulated by HHS and USDA as “overlap” select agents. The Bioterrorism Response Act defines the term “overlap agents and toxins” to mean biological agents and toxins that are listed pursuant to 42 U.S.C. 262a(a)(1) and listed pursuant to 7 U.S.C. 8401(a)(1). If HHS/CDC removes any overlap select agents from its list, these agents might still be regulated as USDA select agents dependent on the outcome of the USDA biennial review.

On March 17, 2020, CDC published an advance notice of proposed rulemaking (ANPRM) (85 FR 15087) seeking public comments on potential changes to the current list of HHS and overlap select agents and toxins that are regulated by both HHS and USDA. The received comments broadly supported removal of the Brucella species—of the 335 comments received, 325 supported removal of one or more species of Brucella. Only two commenters were in favor of retaining the Brucella species.

HHS/CDC engaged the Intragovernmental Select Agents and Toxins Technical Advisory Committee (ISATTAC) to review and consider the public comments. The committee reviewed the public comments over a series of seven meetings held between June 12, 2020, and December 11, 2020. Other Federal subject-matter experts were invited to the meetings to address questions from the committee. The ANPRM also requested input on removal of other agents from the list ( e.g., Coxiella burnetii, Rickettsia prowazekii, Bacillus anthracis [Pasteur strain]). After considering public comments, ISATTAC advisory input, and Federal subject-matter experts' input, CDC proposed changes to the select agent and toxin list and removal of three species of Brucella.

On January 30, 2024, HHS issued a proposed rule entitled “Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins” (89 FR 5823). The proposed rule included two sets of proposals: (1) regulatory changes related to the select agents and toxins on the list ( i.e., remove three species of Brucella from the list of overlap select agents and toxins, raise one toxin's exclusion amounts, rename three viruses, designate a current agent as a Tier 1 agent, and remove the designation of Tier 1 status from one agent), and (2) regulatory changes related to the administration of FSAP. This second set of proposals included adding definitions and provisions to clarify inactivation of select agents, adding requirements to report discoveries of select agents and toxins, and codifying policies regarding effluent decontamination systems and biosafety provisions for facility verification requirements for registered biosafety level 3 and animal biosafety level 3 laboratories.

HHS/CDC has elected to finalize the January 30, 2024, proposed rule in two separate rulemakings—one final rule focused on changes to the select agents and toxins list (this final rule), and a second final rule focused on regulatory changes to the administration of the FSAP discussed above. This final rule will focus solely on removing three select agents, raising one toxin's exclusion limit, updating nomenclature, and designating an agent as Tier 1. HHS/CDC is proceeding with two final rules for clarity and to avoid any unnecessary delay in finalizing the revised select agents and toxins list. HHS/CDC will publish another regulatory action focused on the proposed rule's administrative and programmatic changes at a later date. Like HHS/CDC, USDA/APHIS is also proceeding with two separate final rules for this rulemaking.

Interested persons or organizations were invited to participate by submitting written views, recommendations, and data. HHS/CDC invited general comments as to whether there are additional biological agents or toxins that should be added or removed from the HHS list of select agents and toxins based on the following criteria outlined under 42 U.S.C. 262a(a)(1)(B):

(1) “the effect on human health of exposure to the agent or toxin;”

(2) “the degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to humans;”

(3) “the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or toxin;” and

(4) “any other criteria, including the needs of children and other vulnerable populations, that the Secretary considers appropriate”.

Comments were also requested on the following specific proposed changes to the list of HHS select agents and toxins:

• Removal of Brucella abortus, Brucella melitensis, and Brucella suis: Proposal to remove Brucella abortus, Brucella melitensis, and Brucella suis from the select agent list.

• Updates to nomenclature of select agents: To change “SARS coronavirus (SARS-CoV)” to “Severe acute respiratory syndrome coronavirus (SARS-CoV)” to correct the nomenclature; to remove the exclusion regarding South American genotype of Eastern Equine Encephalitis virus as this terminology is no longer the correct nomenclature; and to rename Ebola virus to Ebolavirus in accordance with the recent taxonomic change by the International Committee on Taxonomy of Viruses (ICTV) (this was initially included as its own section in the proposed rule but moved under this section for nomenclature changes).

• Updates to nomenclature of monkeypox virus: Proposal to update the terminology of “monkeypox virus,” which was initially proposed to be updated to “Mpox Clade I.”

• Removal of the Designation of Botulinum neurotoxin producing species of Clostridium as a Tier 1 Agent: Proposal to retain botulinum neurotoxin producing species of Clostridium as an HHS select agent, but no longer list it as a Tier 1 agent.

• No Addition of Hantaviruses: Proposal to not add Sin Nombre virus (SNV), Andes virus (ANDV), Hantaan virus (HTNV), and Dobrava virus (DOBV) to the select agent list.

• Toxin Review: Changes to Exclusion Limits for Short, Paralytic Alpha Conotoxins: Proposal to increase the exclusion amount for short, paralytic alpha conotoxins from 100 mg to 200 mg.

• Designation of Nipah virus as a Tier 1 Select Agent: Proposal to designate Nipah virus as a Tier 1 select agent.

• Addition of a Footnote to the HHS Select Agent List on the FSAP website: Proposal to add a footnote to the list for HHS and Overlap select agents indicating that the current nomenclature will be available on the FSAP website ( https://www.selectagents.gov ) to harmonize the list of select agent viruses with ICTV nomenclature.

The public comment period for the proposed rule ended on April 1, 2024. HHS/CDC received 44 unique comments from individuals, stakeholders, and groups and carefully reviewed and considered the comments in this preparation of the final rule. Of these 44 comments, 37 include discussion of the list of select agents discussed in this final rule. A summary of the comments relevant to the content of this final rule and responses to those comments are found at section II, below. Public comments addressing other topics from the proposed rule will be addressed in a separate regulatory action.

The following is a section-by-section discussion of the changes HHS/CDC is making to the list of select agents and toxins in 42 CFR 73.3 and 73.4 after consideration of public comments. As previously stated, the changes proposed in the proposed rule will be finalized in two separate rules. This final rule addresses changes to the list of select agents and toxins in 42 CFR 73.3 and 73.4. All other revisions to definitions, policies, and regulatory requirements addressed in the proposed rule will be addressed in a separate final rule.

Regarding the request for comment on whether to remove three species of Brucella ( B. abortus, B. melitensis, and B. suis ) from the select agent and toxins list, HHS/CDC received 37 comments from individuals, animal health groups, regulated entities, and public health associations that fully supported removing the three agents. No public comments proposed maintaining these agents on the select agent and toxins list.

Individuals and animal health groups stated that they support removing B. abortus, B. melitensis, and B. suis to allow for more robust studies on alternative methods of surveillance, effective delivery mechanisms for wildlife vaccination, and techniques to limit disease spread, such as contraception and novel sustained-release antibiotics in conjunction with immuno-contraception. Commenters stated the etiology and pathophysiology of the Brucella species make it poorly suited to cause a severe threat to human health. Commenters further noted that the disease is extremely rare in North America and has limited capacity for human-to-human transmission. The same commenters stated maintaining the Brucella species as select agents causes considerable burden to the research community, impairing necessary scientific developments of diagnostic tools and vaccine delivery methods. Regulatory constraints on Brucella species were further correlated to fewer individuals entering the field of Brucella research. The commenters agreed removal of these agents would not affect the nationally recognized biosafety measures used by U.S. researchers in handling these agents. Commenters also noted that, regardless of the FSAP's regulation of these agents, Brucella species remain endemic worldwide. This change would, however, enhance proactive measures for research and diagnostics.

State veterinarians, state agriculture departments, and livestock associations also support the removal of the Brucella species and believe delisting these agents will allow for faster production of improved diagnostics. These groups believe delisting ultimately will reduce the cost for ranching families and other taxpayers when performing the required testing on domestic livestock. These groups stated that current tests often cross-react or result in false positives that threaten animal agribusinesses; the benefits to delist the Brucella species are numerous; and the perceived risk to national security is not supported by peer-reviewed science. One group stated removal of these agents is a step toward using a modernized risk-based approach for biosafety and security.

Regulated entities ( i.e., entities registered with FSAP under 42 CFR 73.7) reported similar support for removing B. abortus, B. melitensis, and B. suis and included that they have no concerns with maintaining work using BSL-3/ABSL-3 practices. Commenters stated that guidance will be needed for the regulated community currently registered for these agents on how to remove registered space and/or removal of Brucella species from registration while active work is ongoing with Brucella.

Public health associations commented that B. abortus, B. melitensis, and B. suis should be removed because of the low mortality rate and because current molecular and diagnostic methods allow for the effective detection of the agents. Comments stated delisting these agents will remove substantial regulatory requirements on individuals, specifically the Responsible Official and Alternate Responsible Official, and allow for an expanded work staff to contribute to testing. Further, antibiotic treatment regimens are effective and well-established for treating brucellosis due to infections with B. abortus, B. melitensis, or B. suis.

In accordance with the proposed rule and public comments, HHS/CDC is removing B. abortus, B. melitensis, and B. suis from the select agent and toxins list upon publication of the final rule. This decision is based on the criteria and considerations outlined in 42 U.S.C. 262a, including the low mortality rate, rare human-to-human transmission, and availability of therapeutics, and is supported by the strong and unanimous support received through public comments in favor of removing these agents (Olsen et al., 2018). Please note that all entities currently working with B. abortus, B. melitensis, or B. suis will need to remove these agents from their APHIS/CDC Form 1 (registration), including Sections 3, 7A/C (and associated attachments), and 7B. FSAP will be reaching out to affected entities upon publication of this final rule. Further guidance can be found at https://www.selectagents.gov/efsap/using/form1/docs/eFSAP_Form_1_Amendments_Guidance_508.pdf.

For brucellosis case reporting and national notification, please visit https://www.cdc.gov/brucellosis/hcp/surveillance/index.html.

Additionally, BSL-3/ABSL-3 laboratory safety and containment recommendations for Brucella species are outlined in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) found at https://www.cdc.gov/labs/bmbl/index.html.

HHS/CDC proposed to amend the select agent list by updating “monkeypox virus” to the regulated virus variant “Mpox virus (clade I).” Initially, HHS/CDC based this change on the World Health Organization (WHO) recommendation to adopt a new disease name from monkeypox to mpox ( https://www.who.int/news/item/28-11-2022-who-recommends-new-name-for-monkeypox-disease ). This was updated in the International Classification of Diseases (ICD) system ( https://icd.who.int/browse/2024-01/mms/en#160886685 ).

Global experts, including the International Committee on the Taxonomy of Viruses, assigned new names to the monkeypox virus variants but not to the virus itself. The virus variants became known as monkeypox virus Clade I (formerly Congo Basin, Central African clade) and Clade II (formerly West African Clade) ( https://www.who.int/news/item/12-08-2022-monkeypox--experts-give-virus-variants-new-names ). These efforts were in part to align the disease name and virus variants with current best naming practices.

FSAP issued guidance during the 2022 mpox outbreak to assist individuals and entities to comply with select agent and toxin regulations after they identified monkeypox virus in diagnostic samples. The guidance clarified that when materials are identified as being or containing monkeypox virus, and the clade is unknown, the materials are considered select agents. The guidance also explained when regulatory exemptions and exclusions would apply. This guidance was issued based on current diagnostic assays not being specific to the monkeypox virus clade.

Based on these considerations and recognition that this change would have implications beyond a change in nomenclature, HHS/CDC will not change the listed agent from “monkeypox virus” to “Mpox virus (clade I).” The decision to retain the existing listing is to ensure consistency in nomenclature and the regulation of select agent material. FSAP does not include clade-specific designations for other select agents, but the regulations provide exclusions when appropriate. This ensures select agent material is possessed, used, and transferred in accordance with the regulations, which is critically important when clade-specific assays are generally used. Therefore, HHS/CDC is retaining the current listing and monkeypox virus, meaning monkeypox virus with clade unknown is a select agent. Likewise, monkeypox virus identified as clade I is a select agent. The decision to retain the current listing means no changes are made to the regulation of this select agent or the applicable exclusions and exemptions.

As mentioned above, monkeypox virus contains two virus variants, or clades. In 2012, HHS/CDC excluded the West African Clade of monkeypox virus from the select agent regulatory requirements ( https://www.selectagents.gov/sat/exclusions/hhs.htm ). Excluded select agents have been determined to not pose a severe threat to public health and safety and are not regulated as select agents. Though not explicitly proposed in the proposed rule, HHS/CDC has decided to rename the excluded West African Clade monkeypox virus to clade II monkeypox virus. This nomenclature change aligns with WHO recommendations (Ulaeto et al., 2023, https://www.who.int/news/item/28-11-2022-who-recommends-new-name-for-monkeypox-disease ). This change promotes consistent terminology in global and public health and will not impact regulated entities.

Additionally, HHS/CDC proposed to change SARS coronavirus (SARS-CoV) to “Severe acute respiratory syndrome coronavirus (SARS-CoV),” which is the correct nomenclature. This nomenclature change was also supported by two comments and is finalized as proposed.

Though “Eastern equine encephalitis virus” is an HHS select agent, the regulations exclude any South American genotype of Eastern Equine Encephalitis Virus from the requirements. HHS/CDC proposed to remove the exclusion regarding South American genotype of Eastern Equine Encephalitis virus as this no longer reflected the appropriate nomenclature, but did not provide the updated virus name. The updated nomenclature of the South American genotype of Eastern Equine Encephalitis virus is “Madariaga virus.” HHS/CDC received two comments requesting clarification on whether Madariaga virus would be excluded from regulatory requirements and one comment in favor of this exclusion. The nomenclature of the excluded South American genotype of Eastern Equine Encephalitis virus is finalized as “Madariaga virus.” For clarity, 42 CFR 73.3(d)(12) will now read as excluding “Madariaga virus” from the regulatory requirements.

Lastly, HHS/CDC proposed the renaming of Ebola virus to the genus Ebolavirus. HHS/CDC received 10 public comments that supported renaming Ebola virus to the genus Ebolavirus to align with the International Committee on Taxonomy of Viruses (ICTV). None of the commenters provided evidence or rationale for their support of this change. One commenter stated that HHS/CDC should also make it clear that any strain that is similar enough to this genus, whether naturally discovered or artificially derived, should be regarded as a select agent. HHS/CDC will not make any changes based on this comment but does note that any virus (including separate strains or species) that is classified as being a member of the genus Ebolavirus would be subject to the requirements of this part. The renaming of Ebolavirus is finalized as proposed.

HHS/CDC also received three public comments recommending the removal of monkeypox virus (clade I) from the HHS list of select agents and toxins. One commenter stated that given the virulence and transmission patterns of circulating strains of clade I combined with the similarity of prophylaxis and treatment measures for both clade I and II, they did not feel it should be regarded as a select agent any longer. Another commenter stated that the risk of a severe monkeypox virus (clade I) outbreak in the United States is likely minimal, given the low risk of casual human-to-human transmission; mild clinical symptoms for immunocompetent people; low mortality rate; an FDA-approved, effective vaccine; availability of pharmacotherapy treatment; and a robust healthcare infrastructure and public health response. The final commenter recommended removal of monkeypox virus (clade I), as its status as a select agent could potentially restrict early detection via wastewater surveillance and may lead to unnecessary burdens on healthcare facilities, particularly in under-resourced communities. This commenter stated that removing monkeypox virus (clade I) from the select agent list would remove barriers to rapid diagnosis, ensure equitable access to care, and streamline public health response efforts by increasing accessibility to testing in the event monkeypox virus (clade I) begins to circulate in the United States. The select agent regulations include provisions that exempt diagnostic laboratories from the requirements, as long as these laboratories secure, destroy, and report positive samples. This exemption allows for continued rapid diagnosis, equitable access to care, and a robust public health response effort. As new data from current outbreaks are collected and analyzed, HHS/CDC will take these comments along with future data into consideration during the next biennial review. The review process considers how the agent affects human health, the degree of transmissibility, if there are effective medical countermeasures available, and the needs of vulnerable populations. Appropriate departments and agencies with scientific experts will also be consulted. At present, more data would be needed to support the removal of monkeypox virus from the select agent list, so monkeypox virus will remain on the list as an HHS-only select agent, and monkeypox virus (clade I) will remain a regulated variant.

Additionally, one commenter stated that they do not support the addition of SARS-CoV/SARS-CoV-2 chimeric viruses, which were previously added as a select agent on November 17, 2021. HHS/CDC is not making changes to the final rule based on this comment. A final rule published on March 3, 2023 (88 FR 13322), outlines the basis for adding SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors as an HHS select agent.

One commenter inquired why H2N2 (a subtype of Influenza A virus) was not considered a select agent, especially since NIAID's Laboratory of Infectious Diseases published that the 1957 pandemic strain of H2N2 would most likely cause a pandemic. As mentioned above, changes to the list of select agents and toxins are carefully considered using specific criteria and in consultation with appropriate departments, agencies, and scientific experts. This review also takes into account current data to support changes to the list. FSAP will continue assessing changes to the select agent and toxin list as part of its ongoing biennial review process, but HHS/CDC is not making any changes based on this comment at this time.

Another commenter stated that, given the further development of reverse genetics systems, FSAP should consider oversight of the nucleic acids, in part or in whole, that could be used to create select agents. HHS/CDC is not making any changes based on this comment but does understand that the ability to synthetically create agents capable of posing a severe threat to public health and safety is becoming less difficult because of newer technologies. HHS/CDC will further review the risks posed by these technologies.

One additional public commenter thanked the Federal Government for transparency regarding the criteria for adding/delisting agents and toxins and strongly supported the continued use of these criteria and processes. Another commenter stated that a list-based approach no longer adequately addresses the current biological threat landscape, which includes unknown, accidental, engineered, and naturally occurring hazardous biological agents and toxins. To address the current biological threat landscape, the commenter stated that FSAP should take into account transmissibility, not just pathogenicity, and should move toward a “tiered, risk-based program” and away from a “list-based program.” HHS/CDC thanks these commenters for their thoughts. HHS/CDC does evaluate transmissibility in the assessments of whether to include an agent in our list, specifically under the direction of the statute that includes contagiousness as a criterion for inclusion. Also, FSAP derives its regulatory authority from section 351A(a)(1) of the Public Health Service Act (42 U.S.C. 262a(a)(1)), which states that HHS/CDC must maintain a list of select agents and toxins. HHS/CDC may consider additional tiering to the list of select agents and toxins at the next biennial review.

Botulinum neurotoxin, which causes botulism, is a Tier 1 select toxin, and botulinum neurotoxin producing species of Clostridium are a Tier 1 select agent, regulated by HHS/CDC. In the 2024 proposed rule, HHS/CDC requested comment on the proposal to retain botulinum neurotoxin producing species of Clostridium as an HHS select agent, but no longer designate it as a Tier 1 agent because the organism itself does not normally cause disease. Botulinum neurotoxin would still be designated as a Tier 1 toxin. HHS/CDC received mixed reactions and a total of 14 comments on whether to downgrade botulinum neurotoxin producing species of Clostridium from a Tier 1 agent, while keeping it as an HHS select agent.

Nine commenters supported downgrading the agent from Tier 1, three opposed the change, and two comments requested clarification of when nucleic acids that encode for toxic forms of botulinum neurotoxin would be considered Tier 1 or non-Tier 1. One commenter stated the most compelling rationale for no longer designating the agent as Tier 1 is that public health outbreaks with this organism are not likely or projected to be particularly disruptive.

Three commenters did not support the change. They stated that no longer designating botulinum neurotoxin producing species of Clostridium as a Tier 1 select agent—while keeping botulinum neurotoxin as a Tier 1 toxin—would introduce ambiguity to procedures related to storage, possession, use, and in the event of an accidental release. One commenter stated that if the neurotoxin remains as a Tier 1 agent and regulatory requirements are only reduced for the organism, it could potentially cause violations relating to an entity producing the toxin in an unregulated manner.

One commenter recommended that if botulinum neurotoxin remains a Tier 1 agent, then botulinum neurotoxin producing species of Clostridium should also remain as Tier 1. Another commenter pointed out that HHS/CDC would need to provide extensive guidance regarding differentiating between experiments or steps in experiments that include both the agent and toxin that require Tier 1 personnel and practices versus non-Tier 1 personnel and practices if this change were to take effect. Both commenters recommended that the agent, toxin, and regulated nucleic acids all be regulated as either non-Tier 1 or Tier 1 because regulating the related materials differently would create a substantial administrative burden to registered entities.

HHS/CDC agrees that public health outbreaks are unlikely to occur with botulinum neurotoxin producing species of Clostridium. Per Executive Order 13546, “Optimizing the Security of Biological Select Agents and Toxins in the United States,” botulinum neurotoxin producing species of Clostridium do not pose a great risk of deliberate misuse with the most significant potential for mass casualties, and therefore do not meet the standard of Tier 1. However, in accordance with several other comments, HHS/CDC agrees that downgrading the agent (or nucleic acids encoding for toxic forms of botulinum neurotoxin) from Tier 1, while continuing to regulate botulinum neurotoxin as a Tier 1 toxin would require registered entities to differentiate between the applicable regulatory requirements, which may cause confusion. Likewise, establishing different regulatory standards for the select agent and related toxin would create challenges for HHS/CDC in assessing compliance. The agent has the inherent ability to produce Tier 1 toxin. In consideration of the logistical challenges raised in the comments referenced above, HHS/CDC will continue to regulate botulinum neurotoxin producing species of Clostridium as a Tier 1 select agent.

In response to the 2024 proposed rule, HHS/CDC received nine public comments that unanimously supported the proposal to not add Hantaviruses [Sin Nombre virus (SNV), Andes virus (ANDV), Hantaan virus (HTNV), and Dobrava virus (DOBV)] to the select agent and toxins list. Eight commenters did not offer a rationale or evidence for their stance; however, one commenter stated that because there is no evidence of sustained person-to-person transmission of SNV, ANDV, HTNV, or DOBV, they concurred with the proposal not to add these viruses to the select agent list. Given the limited direct person-to-person transmission and difficulty propagating in a laboratory setting, it is unclear whether Hantaviruses would pose a severe threat to public health and safety. In accordance with the criteria and considerations for determining whether to include an agent or toxin on the list as articulated in 42 U.S.C. 262a, as proposed and in addition to the unanimous support for not adding these agents via public comment, HHS/CDC will not be adding SNV, ANDV, HTNV, and DOBV as HHS select agents.

In response to the 2024 proposed rule, HHS/CDC received eight public comments that unanimously supported the proposal to increase the exclusion amount for short, paralytic alpha conotoxins from 100 mg to 200 mg. HHS/CDC proposed this change based on assessments of lethal doses of conotoxin compared to other regulated toxins and the amount of the toxin that would be needed if a bad actor sought to weaponize it. To assess the amount necessary to weaponize a biological toxin, the Department of Homeland Security (DHS) developed toxin parameters and attack scenarios for potential inhalation and ingestion exposures to select toxins. The DHS models determined the impact of the dissemination of varying concentrations of toxins on public health. HHS/CDC reviewed the DHS models, and the lethal doses of conotoxins are comparable to other regulated toxins with a much higher permissible amount. Based on the DHS model and the public comments mentioned above, HHS/CDC is raising the exclusion limit for conotoxin from 100 mg to 200 mg as proposed.

In the 2024 proposed rule, HHS/CDC sought public comment on whether Nipah virus should be identified as a Tier 1 select agent because of its human transmissibility, high case fatality rate, low infectious dose, high severity of illness, and severity of long-term effects.

HHS/CDC received a total of 10 comments on this proposal. One commenter was in favor of designating Nipah virus as a Tier 1 select agent, especially given the known person-to-person transmissibility of the virus. There were nine commenters against this change. Eight of these commenters stated the justification is not sufficient support for designating Nipah virus as a Tier 1 select agent over other agents on the select agent list that are Risk Group 4 pathogens. One commenter thought it was unclear what value the Tier 1 designation would have for Nipah virus.

CDC disagrees with these commenters. Executive Order 13546, “Optimizing the Security of Biological Select Agents and Toxins in the United States,” directs the HHS Secretary to designate a subset of select agents and toxins as Tier 1 that present the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure, or public confidence. Nipah virus has high human transmissibility; a high case fatality rate (estimated between 40-100%); a low infectious dose (ranging from 10 1 −10 7 plaque forming units depending on route of infection); high severity of illness; and severe long-term effects, including neurological complications including encephalopathy, cranial nerve palsies, and dystonia (Sejvar et al., 2007 and Lo et al., 2008).

For these reasons, HHS/CDC is designating Nipah virus as a Tier 1 select agent.

In the 2024 proposed rule, HHS/CDC received one public comment that supported the proposal to add a footnote to the list of HHS and Overlap select agents indicating that the current ICTV nomenclature for select agent viruses, if different from that published in the HHS regulations, will be available on the FSAP website ( https://www.selectagents.gov ). This commenter stated that the FSAP website is a good place to provide this information. As proposed, HHS/CDC will proceed with adding a footnote to the list for HHS and Overlap select agents for this purpose.

In summary of the discussions in section II. of this rule, HHS/CDC is finalizing these revisions to the Federal Select Agent Program at 42 CFR part 73:

• Remove Brucella abortus, Brucella melitensis, and Brucella suis from the select agent list.

• Update the nomenclature of select agents:

○ Change “SARS coronavirus (SARS-CoV)” to “Severe acute respiratory syndrome coronavirus (SARS-CoV)” to correct the nomenclature;

○ Rename the exclusion of “South American genotype of Eastern Equine Encephalitis virus” to “Madariaga virus”;

○ Rename the exclusion of “West African Clade of Monkeypox virus” to “clade II monkeypox virus”;

○ Rename Ebola virus to Ebolavirus in accordance with the recent taxonomic change by the International Committee on Taxonomy of Viruses (ICTV);

• Retain nomenclature of monkeypox virus;

• Retain designation of botulinum neurotoxin producing species of Clostridium as a Tier 1 agent;

• No addition of Hantaviruses: specifically not adding Sin Nombre virus (SNV), Andes virus (ANDV), Hantaan virus (HTNV), and Dobrava virus (DOBV) to the select agent list;

• Increase the exclusion amount for short, paralytic alpha conotoxins from 100 mg to 200 mg;

• Designate Nipah virus as a Tier 1 Select agent;

• Add a footnote to the list for HHS and Overlap select agents indicating that the current nomenclature will be available on the FSAP website ( https://www.selectagents.gov ).

Under 42 U.S.C. 262a(a)(2), the HHS Secretary must review and republish the list of HHS select agents and toxins at least biennially. This ensures scientific advancements and gained knowledge are applied to each agent and toxin on the list.

Below are reasonable regulatory alternatives considered regarding key individual provisions listed in this final rule.

This final rule contains several updates to outdated nomenclature of agents, including monkeypox virus, Severe acute respiratory syndrome coronavirus (SARS-CoV), and Ebolavirus. Retaining outdated nomenclature is not scientifically accurate and causes confusion when organizations seek to be in compliance with the regulations. Retaining outdated nomenclature can also cause discrepancies between HHS/CDC and other global health organizations. There is a low, one-time cost associated with updating nomenclature. The alternative of finalizing the rule without the proposed changes, i.e., retaining outdated nomenclature, is not feasible or accurate.

Several changes in this final rule also ensure continued compliance with E.O. 13546.

If HHS/CDC were to retain Nipah virus without a Tier 1 designation, the select agent and toxin list would have an agent that has a great risk of deliberate misuse with the potential for mass casualties, like other Tier 1 select agents, but without the additional provisions outlined for Tier 1 select agents and toxins. These additional provisions include advanced security even compared to non-Tier 1 agents, laboratory personnel enrollment in an entity-specific Occupational Health Program, and that entity-specific risk assessments include Nipah virus as a Tier 1 agent. Not having Nipah virus designated as Tier 1 select agent could potentially result in entities or personnel handling the agent incorrectly, causing public health, biosafety, and biosecurity concerns. It also would not enable FSAP to ensure and require compliance with the enhanced Tier 1 biosafety and biosecurity requirements provided for in the regulations.

All entities currently registered with FSAP for Nipah virus are also registered for other Tier 1 select agents and toxins. Therefore, these entities have Tier 1 provisions in place already that can be applied to Nipah virus. If HHS/CDC were to retain Nipah virus as a select agent without Tier 1 designation, the department and agency would be out of compliance with E.O. 13546. It could also potentially cause public health and biosecurity concerns in that the agent is not handled appropriately. Nipah virus has high human transmissibility; a high case fatality rate (estimated between 40-100%); a low infectious dose; high severity of illness; and severe long-term effects.

Along similar reasoning, new models from DHS illustrate the lethal doses of conotoxins are comparable to other regulated toxins with a much higher permissible amount. The alternative to not raising the permissible toxin limit for short, paralytic alpha conotoxins would lead to irregularities of regulatory application as it pertains to select toxins. Keeping the permissible toxin limit at 100 mg for short, paralytic alpha conotoxins could prevent research and advancement of understanding the select toxin, with no advancement on biosafety and biosecurity. The raised permissible toxin limit of 200 mg will allow more research to occur with the select toxin with no effect on public health and safety. It is important that HHS/CDC considers new data while reviewing the select agent and toxin list to ensure the list is in accordance with criteria and considerations as articulated in 42 U.S.C. 262a.

Similarly, the final rule does not include adding Hantaviruses ( i.e., Sin Nombre virus (SNV), Andes virus (ANDV), Hantaan virus (HTNV), and Dobrava virus (DOBV)) to the list as was initially proposed in the ANPRM. Adding Hantaviruses to the list would lead to the agency regulating agents that are not proven to pose a severe threat to public health and safety. Hantaviruses have limited direct person-to-person transmission and are difficult to propagate in a laboratory setting. At this time, research shows it is not certain that Hantaviruses require any regulation in accordance with the criteria and considerations as articulated in 42 U.S.C. 262a. If FSAP were to begin regulating Hantaviruses, there would be costs associated with onboarding, inspecting, and managing those entities that would be required to register with FSAP, with no current need to regulate the agents.

The most significant impact of this rule is the delisting of Brucella species, and HHS/CDC has carefully considered the alternative of delisting the agents, which would be retaining the agents on the list and continuing regulating these agents.

Retaining the Brucella species on the list has several economic, agricultural, and economic effects with little biosecurity benefit. Most notably, retaining Brucella species on the list prevents researchers from progressing advancement of science with regards to study of the agents and development of countermeasures for this agent by subjecting these laboratories to FSAP's regulatory authority. These agents are designated as Risk Group 3 agents, meaning entities and organizations will continue working with these agents at the appropriate biosafety level (Biosafety Level 3), as outlined in the national standard Biosafety in Microbiological and Biomedical Laboratories, 6th edition.

Continuing regulation of Brucella melitensis, suis, and abortus has a one-time cost of approximately $29k to an entity that wishes to register with FSAP for work with these agents. This cost to the regulated community, due to the reasons listed above, does not enhance biosafety and biosecurity, and may be a regulatory burden to entities that wish to advance understanding of the agent and research medical countermeasures.

There is no alternative to foregoing review of the select agent and toxin list. This rulemaking is intended to meet the regulatory mandate under 42 U.S.C. 262a(a)(2) where the HHS Secretary must review and republish the list of HHS select agents and toxins at least biennially. CDC conducts the biennial review in consultation with CDC's Intragovernmental Select Agents and Toxins Technical Advisory Committee (ISATTAC). An alternative to the rule was to not delist three select agents, not raise the exclusion amount of a regulated toxin, not update nomenclature, and not add the Tier 1 designation to a select agent. Retaining the Brucella species would maintain the current status quo; it does not consider that these agents no longer pose a severe threat to public health and safety, does not promote better research and vaccine development, and does not align with USDA's decision to delist the Brucella agents. Additionally, the alternative to not amend the select agent list is inconsistent with USDA's rule, creating regulatory conflict. In addition, this option is not consistent with the public comment received to support amending the select agent list.

After carefully considering the technical input of subject-matter experts, both within the Federal Government and from public comments, and recommendations from Federal advisory groups, HHS/CDC is finalizing the changes listed in section II, part I (Summary of Final Rule Provisions) above to the list of select agents and toxins.

The HHS/CDC modifications to the list of select agents and toxins addressed in this rule will benefit producers, research and reference laboratories, and state and Federal oversight agencies, while also maintaining adequate program oversight of select agents and toxins. Specifically, HHS/CDC is removing Brucella abortus, Brucella melitensis, and Brucella suis from the select agent and toxin list; updating the nomenclature for several select agents (“SARS coronavirus (SARS-CoV),” removing the exclusion regarding “South American genotype of Eastern Equine Encephalitis virus,” renaming the exclusion regarding “West African Clade of Monkeypox virus,” and “Ebola virus”); retaining the nomenclature of Monkeypox virus; retain the Tier 1 designation of Botulinum neurotoxin producing species of Clostridium; no addition of Hantaviruses to the current select agent and toxin list; increase the exclusion amount for short, paralytic alpha conotoxins from 100 mg to 200 mg; and designating Nipah virus as a Tier 1 Select Agent. HHS/CDC is also adding a footnote to the list for HHS and Overlap select agents indicating that the current nomenclature will be available on the website ( www.selectagents.gov ).

Currently, 236 entities are registered with the Federal Select Agent Program (FSAP). Of these entities, there are 13 private entities, 30 Federal entities, 42 commercial entities, 84 academic entities, and 67 state entities (registered with either APHIS or CDC, depending on the select agents and toxins they work with). Less than 4 percent of all firms operating within these North American Industry Classification categories are considered to be small entities. This final rule will not have a significant economic impact on a substantial number of small entities.

The benefits of strengthened safeguards against the unintentional or deliberate release of a select agent or toxin greatly exceed the costs of complying with the regulatory requirements. As an example of losses that can occur due to a select agent release, the October 2001 anthrax attacks caused 5 fatalities and 17 illnesses, disrupted business and government activities (including $2 billion in lost revenues for the U.S. Postal Service) and required more than $23 million to decontaminate one Senate office building and $3 billion to decontaminate postal facilities and procure mail-sanitizing equipment. Deliberate introduction greatly increases the probability of a select agent becoming established and causing wide-ranging and devastating impacts to the economy, other disruptions to society, and diminished confidence in public and private institutions.

HHS has examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), Executive Order 14094, entitled “Modernizing Regulatory Review” (April 6, 2023), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), and Executive Order 13132 on Federalism (August 4, 1999). This final rule does not meet the criteria set forth in 5 U.S.C. 804(2) under the Congressional Review Act.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 14094 (the Modernizing E.O.) amends section 3(f) of Executive Order 12866 (Regulatory Planning and Review). The amended section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) having an annual effect on the economy of $200 million or more in any 1 year (adjusted every 3 years by the Administrator of Office of Information and Regulatory Affairs (OIRA) for changes in gross domestic product), or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or Tribal governments or communities; (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise legal or policy issues for which centralized review would meaningfully further the President's priorities or the principles set forth in this Executive order, as specifically authorized in a timely manner by the Administrator of OIRA in each case. OIRA has determined that this rule is significant.

As discussed above, HHS/CDC is removing Brucella abortus, Brucella melitensis, and Brucella suis from the select agent list; updating the nomenclature for several select agents (“SARS coronavirus (SARS-CoV),” the exclusion regarding “South American genotype of Eastern Equine Encephalitis virus,” the exclusion regarding “West African Clade of Monkeypox virus,” and “Ebola virus”); retaining the nomenclature of Monkeypox virus; retaining the Tier 1 designation of Botulinum neurotoxin producing species of Clostridium; not adding Hantaviruses to the current select agent list; increasing the exclusion amount for short, paralytic alpha conotoxins from 100 mg to 200 mg; and designating Nipah virus as a Tier 1 Select Agent. HHS/CDC is also adding a footnote to the list for HHS and Overlap select agents indicating that the current nomenclature will be available on the website ( www.selectagents.gov ).

Some of the regulatory changes described in the preamble and reported below are a minor in nature, and as such, are expected to have minimal impact on the costs and benefits of current regulations, except for the one-time costs of updating official documents for CDC. These regulatory changes are the updates to the nomenclature for several select agents (“SARS coronavirus [SARS-CoV],” the exclusion regarding “South American genotype of Eastern Equine Encephalitis virus,” the exclusion regarding “West African Clade of Monkeypox virus.” and “Ebola virus); retaining the nomenclature of Monkeypox virus, retaining the Tier 1 designation of Botulinum neurotoxin producing species of Clostridium; no addition of Hantaviruses to the current select agent list ; increasing the exclusion amount for short, paralytic alpha conotoxins from 100 mg to 200 mg; and designating Nipah virus as a Tier 1 Select Agent.

This final rule changes the regulatory baseline by removing Brucella abortus, Brucella melitensis, and Brucella suis from the select agent list. As of July 2024, of the 236 registered entities with FSAP, 112 were registered for select agents and toxins including Brucella abortus, melitensis, and/or suis, and three of those entities were registered for only Brucella species. CDC expects the three entities registered for only Brucella species will deregister from FSAP, which HHS/CDC expects will cause minimal savings for these laboratories, as well as CDC. The remaining 109 entities will likely submit amendments to their registrations to remove the delisted agents while maintaining the rest of their registration. Therefore, HHS/CDC expects no change in the costs for these entities; there is no cost to deregister with FSAP. Because of the small number of entities that will deregister due to the delisting of Brucella species, the cost-savings to the government will be minimal, roughly a net value (benefits-costs) of $8,795.78 in one-time cost savings.

This final rule does not impose any mandatory costs on the public and benefits laboratories who choose to develop research using Brucella abortus, Brucella melitensis, and Brucella suis. Nonetheless, the changes in this rule will have a minimal economic impact on CDC due to the process of updating official documentation for the implementation of the changes listed in this final rule.

To estimate the cost to CDC of including the changes listed in this final rule in official documents, HHS/CDC assumed that 1 GS-14, step 5 employee and one GS-15, step 5 employee each spend 40 hours ( i.e., 80 hours in total) for any updates to cite the language in this final rule. The hourly wage rates for two employees based in Washington-Baltimore-Arlington, DC-MD-VA-WV-PA are $75.70 (GS-14) and $89.03 (GS-15). 1 To account for the non-wage benefits, we multiplied the wage cost by two to result in a total cost estimate of $13,178 (table 1).

The changes in this final rule that are minor in nature and should not result in an additional regulatory burden to regulated entities. Instead, they should help reduce costs by reducing confusion regarding the requirements for the possession, use, and transfer of biological select agents and toxins.

The elimination of Brucella abortus, Brucella melitensis, and Brucella suis from the select agents and toxins list should not result in additional regulatory burden for CDC or regulated entities as this change would imply less regulatory burden. However, one concern about this reduction in regulatory burden is that it could cause costs or losses to the general public by increasing the risk of Brucella abortus, Brucella melitensis, and Brucella suis being accessed without authorization, stolen, lost, or released. Although this cost cannot be measured until after the regulation has been applied, HHS/CDC expects that the risk of Brucella abortus, Brucella melitensis, and Brucella suis being accessed without authorization, stolen, lost, or released would be minimal as the current recommended best practices in place to mitigate these biosafety and biosecurity risks ( Biosafety in Microbiological and Biomedical Laboratories ) will remain in place. USDA's prevention and eradication efforts against Brucellosis from livestock in the United States through the National Bovine Brucellosis Surveillance Plan and the National Brucellosis Eradication program will continue even with the changes in this rule.

Another concern linked to the reduction in regulatory burden to agencies and laboratories is that it could increase cost to the general public by increasing the risk of Brucella abortus, Brucella melitensis, and Brucella suis becoming an agent of interest to be used as a bioweapon. Although this risk cannot be measured by HHS/CDC currently, HHS/CDC expects this risk to be minimal as recent literature indicates that Brucella' s “minimal mortality, availability of treatment options, protracted inoculation period and the emergence of new, more virulent potential weapons means that its inclusion among agents of bioterrorism is nowadays mainly of historical significance.”  3

Increasing the exclusion limits for short paralytic alpha conotoxins will have a negligible impact on costs for regulated entities. There are only four registered entities currently working with these conotoxins, and increasing the exclusion limit will allow for additional research and testing without the additional burden of select agent and toxin regulatory requirements.

Change to the designation of Nipah virus as a Tier 1 select agent will have a negligible impact on costs for regulated entities. All eight of the entities that are currently registered for Nipah virus are already registered for other Tier 1 select agents; therefore they are already complying with the additional Tier 1 requirements and will not incur additional costs with this change.

HHS found the benefits of this rulemaking to outweigh the costs to regulated entities as all the changes described in this final rule have a zero cost to regulated entities. Furthermore, these changes are likely to reduce regulated entities' costs by simplifying their processes and reducing some of the regulatory burden. HHS/CDC is unable to quantify the cost reductions to regulated entities due to the minor changes but expects this final rule will potentially simplify processes for them. Nonetheless, at a minimum, costs of these changes are zero for regulated entities, thus any simplification of processes coming out of this change implies a gain.

As of July 2024, of the 236 registered entities with APHIS and CDC, 112 were registered for select agents and toxins including Brucella abortus, melitensis, and/or suis, and three of those entities are registered for only Brucella species. CDC expects the three entities registered for only Brucella species will deregister from FSAP, which HHS/CDC expects to cause small savings for these entities. Although FSAP registration does not have a direct cost for regulated entities, HHS/CDC estimates that it takes 12 hours of labor a week for eight months to perform the registration processes required to get an FSAP registration. These activities are usually performed by a Responsible Official/Biosafety Officer or an Alternate Responsible Official/Biosafety Officer. The GS scale for these professionals typically ranges from GS-9 to GS-14. Assuming a GS-14 scale, the hourly wage rate based in Washington-Baltimore-Arlington, DC-MD-VA-WV-PA is $75.70. Thus, the estimated one-time cost of registration with FSAP for an entity is $29,069. This estimated one-time cost savings will apply to any entities not registered with FSAP that wish to work with Brucella species. Renewal of registration with FSAP is a negligible cost as the process takes less than 10 minutes. Because three entities are currently registered solely for Brucella species, the exclusion of Brucella abortus, Brucella melitensis, and Brucella suis from the select agent list means they will not need to participate in the registration renewal process, which is a negligible cost.

HHS/CDC expects that the deregistration of the three entities registered only for Brucella species with FSAP will also cause small one-time cost-savings to CDC, as CDC personnel will no longer follow these entities throughout the registration process. HHS/CDC estimates that CDC personnel spend about three hours a week for six months reviewing laboratories' Standard Operating Procedures (SOPs) for entity's registration applications to FSAP. Assuming that the CDC staff reviewing SOPs is GS-13 step 5, the hourly salary in 2024 dollars would be $64.06, thus the one-time cost savings to CDC of reviewing the SOPs required for one entity's registration is $1,153.08, and this implies a total of $3,459.24 in cost savings for CDC of not going through the registration process of the three entities that would deregister after the publication of this rule.

In addition to these cost savings CDC will also have cost savings from not having to perform inspections on the three entities that are ending their FSAP registrations as a result of the exclusion of Brucella abortus, Brucella melitensis, and Brucella suis from the select agent list. Assuming that the personnel performing the inspections are a GS-12 step 5, and a GS-13 step 5 inspectors, the hourly wage is $53.87, and $64.06, respectively. Using an overhead multiplier of 2 to take into account non-wage benefits, and considering the travel costs of inspections, HHS/CDC estimates one-time costs savings of $10,564.18 per inspection not performed per entity (table 2). Since each entity goes through at least one inspection during registration, HHS/CDC estimates CDC will have a cost savings of at least $31,692.54 due to inspections not performed for the three entities deregistering from FSAP.

Executive Order 14094 reaffirms the principles of E.O. 12866 and E.O. 13563 and states that regulatory analysis should facilitate agency efforts to develop regulations that serve the public interest, advance statutory objectives, and are consistent with E.O. 12866, E.O. 13563, and the Presidential Memorandum of January 20, 2021 (Modernizing Regulatory Review). Regulatory analysis, as practicable and appropriate, should recognize distributive impacts and equity, to the extent permitted by law. HHS/CDC developed this final rule in a manner consistent with these requirements. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. HHS/CDC developed this final rule in a manner consistent with these requirements. In administering FSAP, HHS, along with USDA, regularly interact with the affected registered entities via email, phone, online webinars, through the eFSAP information system, and through designated points of contact at registered entities. All changes result from entity questions received or interaction with registered entities who have contacted FSAP when they had questions or regulatory interpretation requests. Therefore, HHS/CDC believes this final rule serves the public interest. Additionally, HHS/CDC encouraged public participation and informed registered entities of the proposed rule via a Select Agent (SA) Gram and a GovD message to ensure they were aware and had a chance to provide public comments. The FSAP website ( www.selectagents.gov ) was updated to share the proposed changes and provided a link to web visitors so that they could review and provide comments on the proposed rule. Lastly, HHS/CDC emailed outreach notes summarizing the proposed rule directly to national partner organizations ( e.g., the Association of Public Health Laboratories, American Society for Microbiology, American Biological Safety Association) so that they could share among their constituents. As discussed above, HHS/CDC carefully reviewed and considered public comments in the development of this final rule.

HHS/CDC examined the impacts of this final rule under the Regulatory Flexibility Act (5 U.S.C. 601-612). Unless HHS/CDC certifies that the final rule is not expected to have a significant economic impact on a substantial number of small entities, the RFA, as amended by SBREFA, requires agencies to analyze regulatory options that would minimize any significant economic impact of a rule on small entities. Currently, 236 entities are registered with FSAP. Of these entities, there are 13 private entities, 30 Federal entities, 42 commercial entities, 84 academic entities, and 67 state entities (registered with either APHIS or CDC, depending on the select agents and toxins they work with). Less than 4 percent of all firms operating within these North American Industry Classification System (NAICS) categories are considered to be small entities. HHS/CDC estimates that 13 entities will be impacted by the changes in this rule. Of these 13 entities, which are not considered small, 4 are associated with colleges, universities, and professional schools; 2 are categorized as research and development in biotechnology; and 7 are part of research and development in the physical, engineering, and life sciences. Applying NAICS' estimation of less than 4 percent of entities classified as small, we find that not even one small entity will be affected by the changes in this rule. Based on our analysis as described above, we certify that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the RFA. In addition, no public comments were received from any small entities on the RFA section.

Based on the information above, this regulatory action is not a major rule as defined by sec. 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This final rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in cost or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of U.S.-based companies to compete with foreign-based companies in domestic and export markets.

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), HHS/CDC determined that the Paperwork Reduction Act does apply to information collection and recordkeeping requirements included in this rule. This final rule focuses on the select agent and toxins list. Any changes to burden hours caused by the removal of Brucella abortus, Brucella suis, and Brucella melitensis from the list of select agents and toxins will be submitted for consideration by OMB under the existing approved PRA package (Possession, Use, and Transfer of Select Agents and Toxins (42 CFR part 73)). Other changes put forth in this final rule, i.e., updating entity registrations to reflect the nomenclature updates to the list, will be instituted by FSAP, resulting in no additional paperwork for the regulated community.

This rule has been reviewed under E.O. 12988, Civil Justice Reform. Once the final rule is in effect, HHS/CDC notes that (1) All state and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.

HHS/CDC reviewed this final rule in accordance with Executive Order 13132 regarding federalism and determined that it does not have federalism implications. The rule does not “have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

In accordance with section 361(e) of the PHSA [42 U.S.C. 264(e)], nothing in this rule would supersede any provisions of state or local law except to the extent that such a provision conflicts with this rule.

Under the Plain Language Act of 2010 (Pub. L. 111-274, October 13, 2010), executive departments and agencies are required to use plain language in documents that explain to the public how to comply with a requirement the Federal Government administers or enforces. HHS/CDC has attempted to use plain language in issuing this rule consistent with the Federal Plain Writing Act guidelines.

For the reasons discussed in the preamble, HHS amends 42 CFR part 73 as follows:

Table of Contents I. Executive Summary II. Final Rule and Responses to Comments A. General (§ 513.1) B. Definitions (§ 513.2(b)) i. Collected Monetary Sanctions ii. Contractor iii. Covered Action and Related Administrative or Judicial Action iv. Dealership v. Employee vi. Independent Knowledge or Analysis vii. Original Information viii. Potential Whistleblower ix. Whistleblower C. Procedures for Submitting Original Information (§ 513.4) D. Confidentiality (§ 513.5) E. Prerequisites to the Consideration of an Award (§ 513.6) F. Whistleblowers Ineligible for an Award (§ 513.7) G. Provision of False Information (§ 513.8) H. Procedures for Making a Claim for a Whistleblower Award (§ 513.9) I. Award Determinations (§ 513.10) J. Appeals of Award Determinations (§ 513.11) K. Form WB-INFO (Appendix A) L. Form WB-RELEASE (Appendix B) M. Form WB-AWARD (Appendix C) III. Regulatory Analyses and Notices I. Executive Summary

The Fixing America's Surface Transportation Act (FAST Act), Public Law 114-94, established important protections and incentives for motor vehicle safety whistleblowers. The Motor Vehicle Safety Whistleblower Act (Whistleblower Act), Sections 24351-25352 of the FAST Act, amended the National Traffic and Motor Vehicle Safety Act of 1966 (Safety Act) to authorize the Secretary of Transportation (the Secretary) to pay an award, subject to certain limitations, to eligible whistleblowers who voluntarily provide original information relating to any motor vehicle defect, noncompliance, or any violation or alleged violation of any notification or reporting requirement of 49 U.S.C. Chapter 301, which is likely to cause unreasonable risk of death or serious physical injury, if that information leads to the successful resolution of a covered action. Public Law 114-94, § 24351-52, 129 Stat. 1716 (2015) (codifying “Whistleblower incentives and protections” at 49 U.S.C. 30172).

In addition to the statutory whistleblower protections and incentives added by the FAST Act, Congress required NHTSA to promulgate whistleblower regulations. 1 NHTSA's notice of proposed rulemaking (NPRM), published on April 14, 2023, 2 proposed definitions of certain terms important to the operation of the whistleblower program, outlined the procedures for submitting original information to NHTSA and applying for awards, discussed NHTSA's procedures for making decisions on award applications, and generally explained the scope of the whistleblower program to the public and potential whistleblowers.

NHTSA received 14 comments on the NPRM. The proposal garnered comments from whistleblower counsel and advocates, vehicle manufacturers, industry associations, and individuals. These comments are available in the docket for this rulemaking. 3 After considering the public comments, the Agency is issuing this final rule and generally adopting the proposal without significant change.

In the NPRM, NHTSA proposed adding a new part to its regulations, 49 CFR part 513, to further implement the whistleblower program established by the Whistleblower Act and codified at 49 U.S.C. 30172. The proposal defined certain terms important to the operation of the whistleblower program, outlined the procedures for submitting original information to NHTSA and applying for awards, discussed the Agency's procedures for making decisions on award applications, and generally explained the scope of the whistleblower program to the public and potential whistleblowers. The proposed rule sought to help facilitate the Agency's identification of information provided by whistleblowers to ensure that whistleblowers receive the protections accorded under the statute and to inform the public of those limited circumstances where information that could reasonably be expected to reveal the identity of the whistleblower may be disclosed. NHTSA sought comments on all aspects of the NPRM.

In response to the NPRM, NHTSA received comments from whistleblower counsel and advocates, vehicle manufacturers, industry associations, and members of the general public. Whistleblower counsel and advocates submitting comments were Cohen Milstein Sellers & Toll PLLC (Cohen Milstein); Constantine Cannon LLP (Constantine Cannon); Kohn, Kohn, and Colapinto (Kohn); and the National Whistleblower Center. The individual vehicle manufacturers that commented were Ford Motor Company (Ford) and Hyundai Motor America (Hyundai). The industry associations that submitted comments were the Alliance for Automotive Innovation (Auto Innovators) and the vehicle supplier industry association Motor & Equipment Manufacturers Association (MEMA). NHTSA also received comments from some individuals.

Generally, most commenters shared their support for the creation of a new part to NHTSA's regulations governing NHTSA's whistleblower program. Commenters addressed many aspects of the rule, including the definitions of certain terms, procedures for submitting information and making a claim for an award, eligibility requirements for an award and award determinations. The order of the topics or comments discussed in this document is not intended to reflect the significance of the comment raised or the standing of the commenter. Additionally, this summary of the comments is intended to provide both a general understanding of the overall scope and themes raised by the commenters, as well as give some specific descriptions to provide context.

Whistleblower counsel and advocates generally commented in support of broadening the definition of “whistleblower,” “independent knowledge or analysis,” and “covered action.” These commenters proposed relaxing internal reporting requirements and more specifically defining protections against retaliation. Additionally, these commenters proposed removing agency discretion for granting an award.

Generally, vehicle manufacturers and industry associations commented in support of restricting the definition of whistleblower and the definition of independent knowledge or analysis. Additionally, these commenters suggested broadening disqualifications for an award. Specifically, these commenters proposed stricter internal reporting requirements and proposed eliminating exceptions to these requirements.

Finally, most individual commenters expressed general support for the goals and content of the proposed rule. Individual commenters focused on the definition of whistleblower and the definition of employee. Additionally, individual commenters expressed concerns about the formalized process to be eligible for an award and the Agency's discretion in granting an award.

This final rule generally adopts the proposal without substantive change. In response to comments, NHTSA has clarified in this final rule the timing for submitting an award claim. In the NPRM, NHTSA proposed a potential whistleblower must file a claim for a whistleblower award by completing the WB-AWARD form and submitting it to NHTSA no later than ninety (90) calendar days from the date of the Notice of Covered Action. This final rule specifies that if the ninetieth day falls on a weekend or federal holiday, the claim deadline is the next business day. NHTSA has also clarified in this final rule that the criminal exclusion is limited to criminal violations decided by a United States federal or state court—not by a foreign tribunal.

While NHTSA also agreed with many other issues raised by commenters, for the reasons discussed below, it does not believe those issues warrant additional or changed regulatory text. After consideration of the comments, NHTSA believes this final rule appropriately balances the need to provide additional guidance on aspects of the statute and Agency's processes, while leaving room for flexibility and case-by-case considerations. As NHTSA has learned through working with numerous whistleblowers since enactment of the FAST Act in 2015, each matter involves unique circumstances. NHTSA will continue to consider these issues as it implements its whistleblower program with the benefit of these new rules and will make future refinements through rulemaking or guidance as necessary and appropriate.

NHTSA maintains information about its whistleblower program on its website, https://www.nhtsa.gov/laws-regulations/whistleblower-program, which it will continue to update with additional information and developments.

Proposed rule § 513.1 provided a general description of NHTSA's whistleblower program. Specifically, it stated that Part 513 describes the whistleblower program that the Agency has established to implement the Motor Vehicle Safety Whistleblower Act, 49 U.S.C. 30172; explained the procedures that the potential whistleblower will need to follow to be eligible for an award; and discusses the circumstances under which information that may reasonably be expected to reveal the identity of a whistleblower may be disclosed by NHTSA. Additionally, it cautioned potential whistleblowers to read the procedures carefully because failure to take required steps within the time frames described could result in disqualification from receiving an award.

NHTSA received no comments on proposed § 513.1. NHTSA is adopting § 513.1 as proposed.

The NPRM contained a proposed definition clarifying that the term “collected monetary sanctions” means monies, including penalties and interest, ordered or agreed to be paid and that have been collected by the United States pursuant to the authority in 49 U.S.C. 30165 or under the authority of 49 U.S.C. 30170. This proposed definition sought consistency with the express terms of the statute, which provides: “Any amount payable [to a whistleblower] . . . shall be paid from the monetary sanctions collected, and any monetary sanctions so collected shall be available for such payment.” 49 U.S.C. 30172(b)(2).

Prior to publication of the NPRM, stakeholders advocated for court ordered restitution to parties other than the United States to be considered monetary sanctions under the regulation. The NPRM proposed that “collected monetary sanctions” cannot reasonably be construed to include such restitution intended to directly compensate victims and other affected third parties (as opposed to penalties paid to the United States).

Commenters Kohn and Constantine Cannon proposed that Congress intended for “collected monetary sanctions” to include restitution intended to directly compensate victims or other third parties. Kohn suggested that restitution required by statute is congressional allocation of monies owed to the United States and thus should be considered money collected and allocated by the United States. Kohn proposed that Congress could have decided to allocate those funds in a different way and thus any sanction paid as the result of an enforcement action must be considered a “collected monetary sanction.”

NHTSA declines to change its proposed definition. The FAST Act, section 31202, appropriates to the Highway Trust Fund amounts equivalent to “covered motor vehicle safety penalty collections.” The section defines “covered motor vehicle safety penalty collections” as any amount collected in connection with a civil penalty under 49 U.S.C. 30165, “reduced by any award authorized by the Secretary of Transportation to be paid to any person in connection with information provided by such person related to a violation of Chapter 301 of such title which is a predicate to such civil penalty.” Based on this section of the FAST Act, it is NHTSA's view that whistleblowers are paid out of the money collected from a paid Safety Act penalty or fine, which is further discussed below with respect to the definition of “covered action.” The Safety Act does not give NHTSA authority to reallocate money collected as restitution intended to directly compensate victims or other third parties. Additionally, Congress neither created a victim allocation fund like that created by the Dodd-Frank Act nor did Congress include restitution in its definition of “monetary sanctions” as it did in the Dodd-Frank Act. 4 It is NHTSA's view that “collected monetary sanctions” does not include restitution intended to directly compensate victims or other third parties because those funds are not “collected” by NHTSA.

Additionally, Kohn proposed that any monetary performance obligations, including agreements to pay a certain amount towards a performance obligation, 5 should be included in the definition of collected monetary sanctions. Kohn suggested that exclusion of money used to satisfy performance obligations would give discretion to NHTSA to manipulate a whistleblower's eligibility and the amount of an award. Kohn asserted that this exclusion sends the wrong message and is counter to legislative intent because it gives money back to the wrongdoer and blocks a whistleblower from obtaining a larger award.

NHTSA does not find this suggestion persuasive. NHTSA does not view performance obligations as constituting a “collected” monetary sanction. Additionally, NHTSA disagrees that exclusion of money used to satisfy performance obligations is in any way a pretext for allowing NHTSA to block whistleblowers from receiving a larger award. Unlike “collected” monetary sanctions, money used to satisfy performance obligations may be an important component of a resolution, helping to ensure that a regulated entity sufficiently addresses ongoing and sustainable compliance with the Safety Act and NHTSA's safety regulations. If there is a collection of the performance obligation amounts in the form of a monetary payment to the United States government as a result of a violation of a consent order, NHTSA agrees that amount is then considered a “collected” monetary sanction. Likewise, in those cases where the agreement specifies that if the total performance amount is not spent and the company is liable for a payment to NHTSA for the balance of the unspent performance amount, 6 and the company pays such amount to NHTSA, that is considered a “collected” monetary sanction.

Similarly, “deferred penalties” or “abeyance amounts” agreed to be paid as a monetary penalty in the event that the company violates the consent order, the Safety Act, or the regulations thereunder are “collected monetary sanctions” if and when the deferred penalty or abeyance amount is actually paid to the United States government.

These views are consistent with the statutory requirement that: “Any amount payable [to a whistleblower] . . . shall be paid from the monetary sanctions collected, and any monetary sanctions so collected shall be available for such payment.” 49 U.S.C. 30172(b)(2). Penalties allocated to performance obligations and deferred penalties that have not been paid to the United States government are neither “collected” nor “available for [ ] payment.”

The NPRM contained a proposed definition of “contractor” as an individual presently or formerly providing goods or services to a motor vehicle manufacturer, part supplier, or dealership pursuant to a contract. NHTSA continues to believe that the definition must include both present and former contractors to maximize the reach and effectiveness of the whistleblower program. For example, if a company terminates a contractor after the contractor reports safety issues, it would not serve the purpose of the Whistleblower Act to bar such a contractor from an award simply because the contractor no longer works for the company. Additionally, whether a contractor is currently or formerly employed has no bearing on whether the contractor has information that might assist NHTSA's vehicle safety work.

One commenter asked if the above definition of “contractor” includes independent contractors. The definition is inclusive of independent contractors and there is no restriction or minimum on how long they worked for or with the motor vehicle manufacturer, part supplier, or dealership.

NHTSA's proposed definitions of “covered action” and “related administrative or judicial action” are based on the definition found in 49 U.S.C. 30172(a)(1). The proposed definition of “covered action” includes any administrative or judicial action, including any related administrative or judicial action brought by the Secretary, NHTSA, or the U.S. Attorney General (Attorney General) under 49 U.S.C. Chapter 301, or the regulations in Chapter 301 that in the aggregate results in monetary sanctions exceeding $1,000,000. Additionally, the proposed rule explains that the more than $1,000,000 threshold can be satisfied if the total amount of monetary sanctions paid by multiple defendants or parties and collected by the United States totals more than $1,000,000 from the covered action. The proposed definition of “related administrative or judicial action” includes “an action that was brought under 49 U.S.C. Chapter 301 by the U.S. Department of Justice, the U.S. Department of Transportation, or the Agency, and is based on the original information provided by the whistleblower.”

NHTSA explained in the NPRM that since the statute specifies that an action is brought by the Secretary or Attorney General “under this chapter,” the statute is referring solely to 49 U.S.C. Chapter 301 and the regulatory obligations promulgated under 49 U.S.C. Chapter 301, as the Whistleblower Act was codified as part of 49 U.S.C. Chapter 301.

Some commenters supported NHTSA's proposed definition. Hyundai agreed that covered actions and related administrative and judicial actions should arise directly under Chapter 301 and the parenthetical phrase “including any related administrative and judicial action” does not encompass actions outside of Chapter 301.

Conversely, some commenters disagreed with this definition and proposed “related administrative and judicial action” to include any related administrative or judicial action, even those not under Chapter 301. Constantine Cannon asserted that interpreting “related” action to mean a subset of “any administrative or judicial action” makes the phrase superfluous and pointed to other areas of the statute that define related action to include actions taken outside of Chapter 301.

NHTSA disagrees that its reading of the statute renders the word “related” superfluous. An example of related actions under the Vehicle Safety Act might be a civil penalty action for a reporting violation of 49 U.S.C. 30166 and a criminal action with respect to the same reporting, pursuant to 49 U.S.C. 30170(a). Moreover, as stated in the NPRM, despite 49 U.S.C. 30172(c)(2)(A)'s mandate that no award shall be made to any whistleblower who is convicted of a criminal violation “related to the covered action” for which the whistleblower would otherwise receive an award, NHTSA does not believe the use of the word “related” in that context is relevant to the scope of a related action under 49 U.S.C. 30172(a)(1). The purpose of the criminal conviction provision in section 30172(c)(2)(A) is to ensure that a whistleblower cannot benefit from their own wrongdoing. That provision is not limited to a related action “under this chapter” and thus has a different (broader) scope based on the plain text of the statute.

The National Whistleblower Center proposed regulatory language that covered actions under the Whistleblower Act include federal enforcement actions outside of Chapter 301. The National Whistleblower Center also proposed a requirement that NHTSA work and coordinate with the U.S. Department of Labor, the U.S. Securities and Exchange Commission (SEC), the Internal Revenue Service, the U.S Commodity Futures Trading Commission (CFTC), the U.S. Environmental Protection Agency, the Federal Trade Commission, and/or the U.S. Department of Justice on any matters related to the Whistleblower Act that may also implicate the violation of laws enforced by these agencies. To further support these proposals, a few commenters pointed to the SEC and CFTC's ability to include actions brought by other agencies under their definitions of “covered action.” NHTSA does not find these proposals persuasive.

Unlike the Whistleblower Act, the SEC and CFTC's governing statutes include a definition of “related action.”  7 Both of these definitions of “related action” specifically incorporate by reference actions brought by other specified, federal agencies. The Whistleblower Act does not contain a definition of related action or any reference to actions other than those brought under Chapter 301. 8 “[R]elated action” under 49 U.S.C. Chapter 301 is given effect by considering two actions under 49 U.S.C. Chapter 301. For example, if NHTSA pursues two separate enforcement actions for violations of 49 U.S.C. Chapter 301, or regulations thereunder, against two different companies (for example, a supplier and a vehicle manufacturer) based on the same facts provided by a whistleblower, in that case, the two separate actions would be related. 9

NHTSA continues to believe that the plain language of the statute is clear and that NHTSA does not have discretion under the statute to consider actions taken under other statutes (such as separate criminal statutes) as part of a “covered action,” even if such actions involve vehicle safety issues and/or are based on facts common to an action taken under 49 U.S.C. Chapter 301.

Kohn outlined concerns that the Department of Justice has a historical preference for bringing actions under Title 18 and the exclusion of monetary sanctions from actions brought under Title 18 will dissuade whistleblowers from coming forward. Similarly, Cohen Milstein, along with other commenters, voiced concerns that a whistleblower would lose incentive to report if an award is dependent on how the government chooses to pursue a wrongdoer. Although NHTSA acknowledges these concerns, the plain language of the statute does not allow NHTSA to include every action under Title 18 or otherwise broaden the reach of the statute.

Additionally, a few commenters argued the specific fund from which NHTSA is obligated to pay a whistleblower should not constrict the definition of “covered action.” However, NHTSA does not believe that the existence of a particular fund is what is restricting the definition of “covered action.” Rather, NHTSA continues to believe that a whistleblower cannot be issued an award percentage of monies paid by a company for criminal violations of statutes other than the Safety Act. Such a reading would be inconsistent with the requirement of the statute that the action be brought “under this chapter.” For example, a criminal action for wire fraud under 18 U.S.C. 1343 is not an action under the Safety Act (49 U.S.C. Chapter 301). However, a criminal action brought under 49 U.S.C. 30170, the criminal penalties provision of the Safety Act, would constitute an action “under this chapter.”  10

In sum, a covered action does not include any action brought by the U.S. Department of Justice under any statute other 49 U.S.C. Chapter 301.

NHTSA proposed to define “dealership” using a broader definition than the statutory definition of “dealer” found in 49 U.S.C. 30102(a)(2). Specifically, NHTSA proposed a “dealership” means a person selling and distributing motor vehicles or motor vehicle equipment primarily to purchasers that in good faith purchase the vehicles or equipment other than for resale. The definition is not limited to a dealership selling new motor vehicles, as in the statutory definition of “dealer.” For example, an employee of a used car dealer could identify and bring to the Agency's attention a safety defect in a vehicle that has not been timely recalled.

Auto Innovators proposed that dealership should only include those with a franchise relationship to the manufacturer and whose products are being reported to NHTSA. Auto Innovators stated it does not believe dealerships without a franchise relationship will likely possess original information.

NHTSA disagrees. A dealership without a franchise relationship can obtain information gained from experiences, communications, and observations. For example, individuals who work at a dealership without a franchise relationship work with motor vehicles and motor vehicle equipment on daily basis and receive purchaser complaints and ready vehicles and vehicle parts for sale. Additionally, some of these dealerships specialize in a particular make and model of a car and would be able to detect issues with the motor vehicles or motor vehicle parts that are likely to cause a risk to motor vehicle safety. Therefore, NHTSA disagrees with Auto Innovators' proposal and believes a limited definition of dealership would not serve the purpose of the Whistleblower Act and would inhibit the reporting of potential safety defects that are likely to cause unreasonable risk of death or serious physical injury.

The proposed definition of “employee” defined “employee” as an individual presently or formerly employed by a motor vehicle manufacturer, part supplier, or dealership. The proposed definition included both present and former employees to maximize the reach and effectiveness of the whistleblower program. As noted above, it would not serve the purpose of the Whistleblower Act to bar a former employee from an award simply because he or she no longer works for the motor vehicle manufacturer, part supplier, or dealership.

The comments all favored the proposed definition of employee to include owners of a motor vehicle manufacturer, part supplier, or dealership. However, Auto Innovators proposed owners of these businesses should not be allowed to benefit if they are reporting their own misconduct or the misconduct of the business enterprise that they own. Constantine Cannon addressed Auto Innovators concern by pointing to proposed § 513.7, on whistleblower ineligibility, which bars whistleblowers who deliberately or substantially contribute to the alleged violation. NHTSA agrees with this view. Further, Auto Innovators proposed a definition of owner that specifies whether the term owner includes anyone with an ownership interest in a business regardless of the size of their interest or the size of their share of a publicly traded company. NHTSA disagrees with a need to define “owner.” Rather, it is NHTSA's position that an owner in this context is generally someone who both owns at least part of a company and holds a permanent employment position or manages at least one employee ( e.g., an owner does not need to be involved in a company's day-to-day operations, but instead can have some sort of limited managerial relationship with the person who manages a company's day-to-day operations).

For example, as proposed by Kohn, owners of dealerships are in an excellent position to gather customer complaints that have a significant impact on public safety. Similarly, NHTSA believes partial owners of businesses who manage employees and oversee operations can learn about and witness safety defects within the supply chain that were not otherwise reported to NHTSA.

Constantine Cannon also proposed the definition of employee should include employees of an automaker's foreign parent company. NHTSA agrees but does not find a need to change the proposed definition to encompass these individuals. The definition of whistleblower under 49 U.S.C. 30172(a)(6) is not limited to those in the United States. The definition in 49 U.S.C. 30172(a)(6) specifies that a whistleblower is an individual who, among other requirements, is an “employee or contractor of a motor vehicle manufacturer, part supplier, or dealership.” The definitions of motor vehicle manufacturer, part supplier, and dealership found in 49 U.S.C. 30102 are also not restricted to only businesses based in the United States. Thousands of motor vehicles and motor vehicle parts are imported and used in the United States every year. Potential whistleblowers who are currently or formerly employed outside the United States might possess vital information related to potential safety defects which are likely to cause unreasonable risk of death or serious physical injury. For example, NHTSA relied upon information from and issued an award to a whistleblower working in South Korea who supplied NHTSA with information in connection to Hyundai Motor America, Inc. and Kia Motors America, Inc.'s violations of the Safety Act. 11 Therefore, it is imperative for NHTSA's safety mission to include those employed outside the United States within the scope of the definition of “employee.” NHTSA has not limited the definition of employee to individuals within the United States and does not find a change to be necessary.

Finally, individual commenters proposed including relatives of employees and contractors and specifying whether there is a minimum time requirement to be considered an employee. NHTSA does not believe that relatives of employees and contractors meet the definition of “whistleblower” found in 49 U.S.C. 30172(a)(6). Congress specifically and unambiguously defined a “whistleblower” as an employee or contractor and made no mention of those related to an employee or contractor. NHTSA also does not believe that there needs to be a minimum time requirement that an individual worked at a motor vehicle manufacturer, part supplier, or dealership for that individual to be considered an employee. Since no time limitation was specified in the definition, NHTSA finds a change to be unnecessary.

NHTSA proposed a definition of “independent knowledge or analysis” because Section 30172(a)(3)(A) states that original information is information that “is derived from independent knowledge or analysis of an individual” (emphasis added). The proposed definition defines “independent knowledge” as factual information in the potential whistleblower's possession that is not generally known or available to the public and is not already known to NHTSA. Publicly available sources include both sources that are widely disseminated, such as corporate press releases and filings, and media reports, as well as sources that, while not widely disseminated, are generally available to the public, such as court filings and documents obtained through Freedom of Information Act requests.

The proposed definition does not require that a potential whistleblower have direct, first-hand knowledge of potential violations. The proposed definition states that the potential whistleblower may gain independent knowledge from the potential whistleblower's experiences, communications and observations in the potential whistleblower's business or social interactions.

MEMA disagreed with the proposed definition's inclusion of those without direct, first-hand knowledge of potential violations. MEMA proposed that those without first-hand knowledge would be unable to assess a potential safety violation resulting in the circumvention of internal processes and communications between part manufacturers and original equipment manufacturers (OEMs). NHTSA disagrees. Those without “first-hand” knowledge, such as an employee of a used-car dealership, may still have the requisite expertise to conduct their own personal analysis and identify a potential safety violation. They might get regular complaints about a particular issue or conduct repairs related to a particular issue on a regular basis. However, only those individuals who are employees or contactors of a motor vehicle manufacturer, part supplier, or dealership could be eligible for an award if they meet the other requirements of 49 U.S.C. 30172 and regulations thereunder.

The proposed definition of “independent knowledge or analysis” further provided that information will not be considered to have been derived from an individual's “independent knowledge or analysis” in some situations.

The first proposed exclusion was for information that was obtained solely through a communication that is subject to attorney-client privilege or the work product doctrine. When describing the proposed exclusion, the NPRM recognized that there are some exceptions to various privileges, such as Federal Rule of Civil Procedure 26(b)(3) (providing that materials prepared in anticipation of litigation may be discovered by an adverse party if the party shows “substantial need” and “undue hardship”), and the crime-fraud exception to the attorney-client privilege.

Several commenters proposed that all information that would be admissible in an administrative, civil, or criminal proceeding should be considered information upon which a reward can be based. Kohn supported this by stating NHTSA's proposed exclusion will encourage corporations to abuse attorney-client privilege. Auto Innovators proposed that NHTSA should establish a process to isolate information while a privileged information determination is made. The National Whistleblower Center proposed a definition excluding information subject to attorney-client or work-product privilege unless it would otherwise be permitted by applicable state attorney conduct rules or rules approved by the Secretary. Similarly, Constantine Cannon proposed that NHTSA use the same definition used by the SEC and CFTC, which includes exclusions for communications subject to attorney-client privilege or in connection with the legal representation that a putative whistleblower has been providing to an employer or firm, unless disclosure is authorized by the applicable federal or state attorney conduct rules.

NHTSA has determined that, pursuant to the District of Columbia Rules of Professional Conduct, attorneys in its Office of the Chief Counsel may not review materials protected by attorney-client privilege. This determination is based on our understanding of the District of Columbia Bar's Ethics Opinion 318: Disclosure of Privileged Material by Third Party. 12 The exclusion is not intended to preclude an individual who has independent knowledge or analysis of potential Safety Act violations from becoming a whistleblower if that person chooses to consult with an attorney or is an attorney. Rather, this exclusion prohibits an employee or contractor from revealing attorney-client privileged or work product information that they learned of solely through a privileged communication. Thus, NHTSA believes the proposed definition remains appropriate and is adopting it in this final rule.

The second proposed exclusion is for information that was obtained in a means or manner that is determined by a United States federal court or state court to violate applicable federal or state criminal law.

Some commenters disagreed with excluding information if the information was obtained in a means or manner found to be illegal by a state court. The National Whistleblower Center proposed language that limits excluded information to information obtained by means or in a manner determined by a United States federal court to violate federal or state criminal law. Kohn proposed removing the exclusion of information obtained in violation of state law because of the possibility of preemption and the differences between state and federal law.

NHTSA disagrees with this proposal. NHTSA believes information obtained in violation of state law should be excluded. NHTSA does not want to encourage employees to obtain information for NHTSA by any means or manner. For example, theft is generally a charge brought under state law rather than federal law. NHTSA does not want to encourage potential whistleblowers to illegally obtain information. In these cases, preemption would generally not be at issue.

In the NPRM, NHTSA urged potential whistleblowers to use caution when providing NHTSA with information covered by a legally binding order or a confidentiality agreement. NHTSA's NPRM recommended that those potential whistleblowers consult with private counsel before submitting such information to NHTSA.

Kohn disagreed with the Agency's proposed suggestion for potential whistleblowers under binding nondisclosure agreements to consult private counsel before providing NHTSA with information. Kohn proposed this suggestion will make whistleblowers think that they are forced to hire private counsel. Similarly, Kohn proposed that the regulations should prohibit private contracts, employment agreements or settlement agreements from interfering with a whistleblower's disclosure to NHTSA. NHTSA disagrees with Kohn on these issues.

NHTSA is obligated to adhere to and support a whistleblower's statutory protections, but NHTSA's attorneys do not represent whistleblowers. Whistleblowers should be aware that “[t]o the extent protective orders, settlement agreements, or other confidentiality provisions prohibit motor vehicle safety-related information from being transmitted to NHTSA, such limitations are contrary to established principles of public policy and law, including Rule 26 of the Federal Rules of Civil Procedure and its state corollaries which require a showing of good cause to impose confidentiality.”  13 However, NHTSA cannot advise a whistleblower that the agreement they are bound by lacks good cause to impose confidentiality. Therefore, if a whistleblower needs legal advice, they should obtain their own private legal counsel. NHTSA continues to suggest that potential whistleblowers who are aware of material protected by a protective order should not provide the documents subject to the order to NHTSA; whistleblowers should inform NHTSA about the existence of such documents without revealing the substance of the material under the protective order.

The NPRM also asked if commenters had suggestions for additional exclusions, including those similar to the exclusions under “independent knowledge” or “independent analysis” within the SEC and CFTC whistleblower programs. One example of a potential exclusion mentioned in the NPRM was excluding information obtained solely because the potential whistleblower is an officer, director, trustee or partner of an entity or a person whose principal duties involve compliance or internal audit responsibilities. The National Whistleblower Center (NWC) proposed that an officer, director, trustee, partner of an entity, or auditor of or within an entity who learns about information from another individual within the entity should generally be excluded from the rule because they lack original information from independent knowledge. Specifically, the NWC proposed that these individuals should be excluded from the rule if they learned about the subject information via an entity's normal processes for identifying, reporting, and addressing potential violations. Additionally, the NWC proposed that individuals whose duties include audits and internal investigations into possible violations also be excluded from the rule.

Conversely, Kohn agreed with NHTSA's proposal to not exclude a potential whistleblower solely because the potential whistleblower was or is an officer, director, trustee or partner. Additionally, Kohn supported NHTSA's proposal to include those participating in or observing internal audit processes. Kohn reasoned that auditors can be pressured to water down reports and this allowance would deter companies from enforcing this pressure. After consideration of the comments, NHTSA has decided it should not exclude officers, directors, trustees or partners. NHTSA believes officers, directors, trustees, partners, and persons whose principal duties involve compliance or internal audit responsibilities all have the potential to learn important information concerning vehicle safety. Furthermore, NHTSA disagrees with the NWC's proposed exclusion because NHTSA believes such individuals may have information that is not generally known or available to the public and is not already known to NHTSA. Excluding such individuals could prevent such valuable safety information from reaching the Agency. Consequently, NHTSA will not exclude such individuals.

However, as discussed above, any illegal action by these persons to obtain the information excludes them from receiving a whistleblower award.

Proposed § 513.2(b) defined “original information” as information that is derived from the independent knowledge or analysis of an individual, is not known to the Secretary or Agency from any other source, unless the individual is the original source of the information; and is not exclusively derived from an allegation made in a judicial or an administrative action, in a governmental report, a hearing, an audit, or an investigation, or from the news media, unless the individual is a source of the information. Proposed § 513.2(b) required that original information be provided to the Agency for the first time after December 4, 2015.

Thomas Kowalick commented, disagreeing with the Agency's proposed prohibition on information provided to the Agency prior to December 4, 2015. However, December 4, 2015 is the date on which Congress enacted the FAST Act. Consequently, this limitation in 513.2(b) is based on the rule of construction contained in Section 24352(b) of the FAST Act. Other commenters supported NHTSA's proposed limitation. 14

The Agency also is making minor edits to the definition of “original information that leads to a successful resolution” for clarity.

To differentiate from the statutory definition of “whistleblower” that contains a number of prerequisites that need to be met to fall under the definition, NHTSA proposed the term “potential whistleblower” for the sake of clarity. The proposed definition of potential whistleblower refers to an employee or contractor of a motor vehicle manufacturer, part supplier, or dealership submitting information to the Agency in accordance with and pursuant to Part 513. Potential whistleblowers will be treated as receiving the whistleblower protections set forth in 49 U.S.C. 30172(f).

Commenters agreed with NHTSA's proposal to treat potential whistleblowers as subject to the protections in 49 U.S.C. 30172(f). Kohn disagreed with limiting a potential whistleblower to an employee or contractor of a motor vehicle manufacturer, part supplier, or dealership. Kohn proposed that anyone who submits information to NHTSA should be considered a potential whistleblower and NHTSA's determination with respect to whether or not a potential whistleblower is eligible should be a separate analysis. NHTSA disagrees with this proposal. NHTSA will not be able to determine whether a person is a “whistleblower” until, at the very least, that person submits information to the Agency and it is evaluated. 49 U.S.C. 30172 limits whistleblower protections to “any employee or contractor of a motor vehicle manufacturer, part supplier, or dealership.” NHTSA does not have the authority to broaden that definition and does not want to encourage people who do not qualify to submit information to NHTSA's whistleblower program. For example, a significant quantity of information that NHTSA receives on vehicle safety issues comes from ordinary vehicle owners and that information is not appropriate for handling under the whistleblower program. NHTSA cannot reasonably consider anyone who submits information to the agency to be a whistleblower, and doing so would divert resources from and adversely impact legitimate whistleblowers. The definition of potential whistleblower as requiring someone to meet the basic requirement of being an employee or contractor of a motor vehicle manufacturer, part supplier, or dealership, in accordance with the statutory definition, appropriately protects those individuals for whom the statutory protections were designed.

Proposed § 513.2(b) defined “whistleblower” as any employee or contractor of a motor vehicle manufacturer, part supplier, or dealership who voluntarily provides to the Agency original information relating to any motor vehicle defect, noncompliance, or any violation or alleged violation of any notification or reporting requirement set forth in 49 U.S.C. Chapter 301 or regulations thereunder, which is likely to cause unreasonable risk of death or serious physical injury. 15

Commenters generally supported NHTSA's proposed definition of whistleblower. Auto Innovators proposed that the regulatory definition should not include entities not covered by the statutory definition of whistleblower such as advocacy groups, media reporters, industry trade associations, or third parties. NHTSA has concluded that the proposed scope was appropriate and consistent with the statute. While NHTSA requested comment on whether employees of trade groups should be included in the definition, after consideration of the comments, NHTSA believes that such an expansion would not be consistent with the statutory definition. However, as NHTSA explained in the NPRM, employees and contractors working for companies within a trade group's membership are eligible to be whistleblowers, provided that they fall into the definition of motor vehicle manufacturer, part supplier, or dealership.

Thomas Kowalick proposed that the definition should only include individuals and not entities. NHTSA agrees. The proposed definition and statutory definition uses the word “employee,” which denotes a single person, and based on this context it would likewise be anomalous to interpret “contractor” to encompass multi-person entities. Therefore, NHTSA does not believe this comment warrants a change.

In the NPRM, NHTSA specifically requested comment on whether a whistleblower must provide original information related to the company that employed or contracted with the whistleblower or whether the employee or contractor of any motor vehicle manufacturer, part supplier, or dealership can report original information regarding any motor vehicle manufacturer, part supplier or dealership (not just the one that employed them or that they were contractors of). Kohn supported NHTSA's proposal that competitors, partners, employees of another separate corporate entity should be entitled to an award under the plain meaning of the statute. NHTSA received no other comments in response to this question.

NHTSA proposed requiring potential whistleblowers to submit information on a standardized form—the proposed WB-INFO form. Proposed § 513.4(a) stated that the standard form must be submitted either by email to NHTSA's established account ( NHTSAWhistleblower@dot.gov ), which is monitored by NHTSA's Office of the Chief Counsel, or by any such method that the Agency may expressly designate on its website. On the WB-INFO form, a potential whistleblower must declare, under penalty of perjury, at the time the potential whistleblower submits information on the WB-INFO form that the information is true and correct to the best of the potential whistleblower's knowledge and belief. 16

Proposed § 513.4(c) provided that a potential whistleblower may submit original information to the Agency anonymously through use of a legal representative. The legal representative must submit the information on behalf of the potential whistleblower pursuant to the procedures specified in 513.4(a).

Kohn commented in support of NHTSA's proposed procedures but objected to requiring that the timing of the submission of a WB-INFO form be determinative of qualification for an award. However, NHTSA's proposed regulations do not specify when the WB-INFO form must be submitted to NHTSA. 17 Therefore, NHTSA agrees with Kohn and will not require the timing of the WB-INFO form to be determinative of qualification for an award, subject to other provisions of the statute and regulations. For example, if a whistleblower initially reaches out to NHTSA without submitting a form (because the person is unaware of the Agency's regulation), the whistleblower can still be eligible for an award if they subsequently submit the WB-INFO form to NHTSA.

In the NPRM, NHTSA proposed that a whistleblower or the whistleblower's legal representative must be the one to directly provide the information to NHTSA. This proposal was based on the statutory requirement that a whistleblower voluntarily provide information to the Secretary. NHTSA also requested comments on whether it should allow non-attorneys to submit information on behalf of a potential whistleblower. Kohn disagreed with requiring the whistleblower or their legal representative to make the submission. Kohn proposed that the statutory definition of original information implies that third parties who learned the information from a whistleblower can report the information to NHTSA, and those whistleblowers should be eligible for an award. Kohn proposed that NHTSA allow whistleblowers to submit information through third parties such as “news media, referrals from Congress or other investigatory agencies, civil society organizations, [or] international anti-corruption or law enforcement authorities.” Further, Kohn proposed that whistleblowers in countries outside the United States, especially in countries with no whistleblower protections, should not be ineligible for a whistleblower award because they used a third party, such as an advocacy group, to relay the information to NHTSA. NHTSA agrees with Kohn with respect to a whistleblower not being disqualified if the whistleblower is initially represented by an advocacy group. Rather, as long as it is clear that an advocacy group is making a submission on behalf of an individual, a whistleblower's eligibility will not be affected. However, to be eligible for an award, NHTSA believes it is important that a whistleblower subsequently contact NHTSA directly about the subject information (in other words, the whistleblower must submit the WB-INFO form). That will help ensure that the Agency can follow up on issues and has the direct, unfiltered perspective of that person.

Similarly, Kohn commented that NHTSA should not require that a whistleblower submit a WB-INFO form to be eligible for a whistleblower award. Kohn pointed to news sources and congressional testimony regarding whistleblowers who shared original information with news media and non-governmental safety organizations rather than directly to NHTSA. Kohn argued that NHTSA will likely continue to obtain useful, original information from these third-party sources where a whistleblower did not go through NHTSA's formal procedures. To support this proposal, Kohn pointed to a whistleblower in the Takata case's interaction with the press alongside that individual's reports to the Department of Justice and the Federal Bureau of Investigation (FBI).

NHTSA disagrees with this proposal. 49 U.S.C. 30172(a)(6) defines a “whistleblower” as someone who “voluntarily provides to the Secretary original information.” (emphasis added). Congress mandated that a whistleblower provide the information to NHTSA to receive a whistleblower award. Further, if a whistleblower provides information to a news source, there is no guarantee that NHTSA will be able to obtain that person's contact information. This is especially true if the source is anonymous. Nothing in this rule prevents a whistleblower from going to the press, the Department of Justice, the FBI, or other authorities in conjunction with a report to NHTSA. If a potential whistleblower goes to one of these other entities first, NHTSA hopes that the other entity would direct the whistleblower to submit information directly to NHTSA. If NHTSA receives a potential whistleblower's contact information from another government agency, news organization, law enforcement authorities, advocacy organizations, or a similar third-party, NHTSA intends to attempt to contact the potential whistleblower and provide them information about how to submit a WB-INFO form.

Consistent with the protections for whistleblowers in 49 U.S.C. 30172(f), NHTSA's proposed § 513.5(a) explained that notwithstanding 49 U.S.C. 30167, the Secretary and any officer or employee of the U.S. Department of Transportation shall not disclose any information, including information provided by a whistleblower to the Secretary, that could reasonably be expected to reveal the identity of a whistleblower, except in accordance with the provisions of 5 U.S.C. 552a, with certain exceptions as provided by statute.

In the NPRM, NHTSA stated it is the Agency's view that if an individual is not a whistleblower, as defined by the statute, the Agency is not bound by the limitations contained in 49 U.S.C. 30172(f). However, it is the Agency's intent to generally afford potential whistleblowers confidential protections, unless otherwise waived or permitted or required by law. NHTSA recognizes that potential whistleblowers often put themselves at risk of significant consequences, and thus maintaining their confidentiality is of the utmost importance.

In the NPRM, NHTSA proposed that an individual discloses information relating to a motor vehicle defect, noncompliance, or violation of notification or reporting requirement that is not likely to cause unreasonable risk of death or serious physical injury, then that person is not a whistleblower and is not entitled to the statutory protection contained in 49 U.S.C. 30172. 18

On September 10, 2014, we published a final rule listing D. cylindrus, along with 4 other Caribbean coral species and 15 Indo-Pacific coral species, as threatened under the ESA (79 FR 53851, September 10, 2014). In early 2021, we announced a 5-year review of 7 threatened Caribbean coral species, including D. cylindrus (86 FR 1091, January 7, 2021) to determine whether the listing classification of these species was still accurate. Based on the findings of the 5-year review (NMFS, 2022), we published a proposed rule to change the status of D. cylindrus from threatened to endangered (88 FR 59494, August 29, 2023). We solicited peer review of the scientific information contained in the proposed rule from three independent experts from the scientific community who have expertise in D. cylindrus biology, ecology, conservation, and threats to the species, and we incorporated their comments prior to publication of the proposed rule. We requested comments on the proposed rule from the public during a 60-day comment period and held a virtual public hearing on September 26, 2023, at which we also accepted public comments.

In this final rule, we are reclassifying D. cylindrus from a threatened species to an endangered species under the ESA. We have determined that D. cylindrus is in danger of extinction throughout all or a significant portion of its range. This final determination is based on the information in the 5-year review, from expert peer reviewers, and from public comments, which together comprise the best scientific and commercial data available.

Section 3 of the ESA defines an endangered species as any species that is in danger of extinction throughout all or a significant portion of its range and a threatened species as one that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range (16 U.S.C. 1532(6) and (20)). Thus, an “endangered species” is one that is presently in danger of extinction. A “threatened species,” on the other hand, is not presently in danger of extinction but is likely to become so within the foreseeable future ( i.e., at a later time). So, the primary statutory difference between a threatened and endangered species is the timing of when a species is in danger of extinction, either presently (endangered) or not presently but within the foreseeable future (threatened).

The statute requires us to determine whether a species is threatened or endangered as a result of any of the factors listed in section 4(a)(1) of the ESA: (A) the present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. Changes to a listed species' status must be determined on the basis of these factors using solely the best scientific and commercial data available (16 U.S.C. 1533(c)(2)(B)). Implementing regulations in 50 CFR 424.11(b) reiterate the requirement that changes in a species' classifications must be based solely on the best available scientific and commercial information regarding a species' status.

Public comments were accepted by standard mail, email, during the public hearing, and through the Federal eRulemaking portal. We received 17 public comments on the proposed rule from individuals, government agencies, and conservation organizations. Of these, 14 comments were supportive of the proposed reclassification of D. cylindrus, 1 comment was against reclassification, and 2 comments were neutral and asked for clarification on the effects of the reclassification. Most of the supportive comments expressed general support for the proposed rule but did not include substantive content. Several comments presented general information on threats or information that was already considered in the proposed rule. We received 3 comments that provided documentation that reinforced the information on demographic factors and threats considered in the proposed rule, including population declines and susceptibility to climate-induced ocean warming, ocean acidification, nutrients, sedimentation, and disease. We also received 1 comment that is outside the scope of the proposed rule that stated that we need to provide support for the increased administrative burden on state and Federal agencies that results from listing and changing the status of species under the ESA, and that we need to increase the Federal funds designated for the management and recovery of ESA-listed species. All substantive public comments on the proposed rule to reclassify D. cylindrus as endangered are addressed in the following summary. We have categorized comments by topic, and, where appropriate, we have combined similar comments from multiple people or groups and addressed them together.

Comment 1: Three commenters provided additional references (Jones et al., 2021, Alvarez-Filip et al., 2022) that addressed population decline of D. cylindrus from disease and were not included in the proposed rule or 5-year review (NMFS, 2022).

Response: We thank these commenters for the submission of additional data to inform the status of the species and this final rule. Jones et al. (2021) suggests that thermal stress in 2014 and 2015 exacerbated underlying disease and resulted in a disease outbreak that led to the extirpation of D. cylindrus in southeast Florida. Alvarez-Filip et al. (2022), reported that greater than 80 percent of D. cylindrus surveyed in Mexico suffered mortality or were infected by disease between 2018 and 2020. Population declines in Florida and Mexico and the threats of disease and ocean warming were considered in the proposed rule as factors leading to the extinction risk of D. cylindrus. The additional references are consistent with the information we considered in the proposed rule. Thus, these comments support our conclusions regarding the threats of ocean warming and disease and provide additional support for our conclusion that D. cylindrus meets the definition of an endangered species. These references were incorporated into the final rule.

Comment 2: We received several comments and references about the threat of climate change and its negative effects on corals that increase the extinction risk for D. cylindrus.

Response: We agree that the effects of climate change are contributing to the risk of extinction of D. cylindrus. In the original listing rule (79 FR 53851, September 10, 2014), we identified factors acting directly as stressors on D. cylindrus ( e.g., elevated ocean temperature and sedimentation) as distinct from the sources responsible for those factors ( e.g., climate change and land management practices) and evaluated the impact each threat has on the species' extinction risk. The susceptibility of D. cylindrus to ocean warming and ocean acidification was addressed in the 5-year review (NMFS, 2022) and in the proposed reclassification rule (88 FR 59494, August 29, 2023). The additional references are consistent with the information we considered in the proposed rule. Thus, these comments support our conclusions regarding the threats of ocean warming and ocean acidification and provide additional support for our conclusion that D. cylindrus meets the definition of an endangered species. Because stressors stemming from climate change are already identified as threats contributing to the extinction risk for D. cylindrus, no changes were made to the final rule in response to these comments.

Comment 3: We received a comment that human activities such as coastal development, dredging, wastewater disposal, and shipping have contributed to the susceptibility of D. cylindrus to stony coral tissue loss disease (SCTLD).

Response: In the original listing rule (79 FR 53851, September 10, 2014), we identified factors acting directly as stressors on D. cylindrus ( e.g., elevated ocean temperature and sedimentation) as distinct from the sources responsible for those factors ( e.g., climate change and land management practices) and evaluated the impact each threat has on the species' extinction risk. Although causative factors of coral disease remain poorly understood, we agree that the presence of stressors such as sedimentation and nutrient enrichment from human activities like coastal development and wastewater disposal can increase the susceptibility of corals to disease. A diseased state results from a complex interplay of factors including the cause or agent ( e.g., pathogen, environmental toxicant), the host, and the environment. The interaction of disease and other stressors was discussed in the original listing rule (79 FR 53851, September 10, 2014), and the susceptibility of D. cylindrus to disease, sedimentation, and nutrients was considered in the 5-year review (NMFS, 2022) and in the proposed reclassification rule (88 FR 59494, August 29, 2023). The public comments are consistent with the information we considered in the proposed rule. Thus, these comments support our conclusions regarding the threats of disease, nutrient enrichment, and sedimentation and provide additional support for our conclusion that D. cylindrus meets the definition of an endangered species.

Comment 4: We received a comment that there is no benefit to changing the status of D. cylindrus to endangered since the ESA has no mechanism of protecting against the major threats of climate change and disease.

Response: Under section 4(b) of the ESA, we are required to base listing decisions solely on the best scientific and commercial data available after conducting a review of the status of the species and after taking into account efforts to protect the species (16 U.S.C. 1533(b)(1)(A)). We may determine a species is threatened or endangered because of any of the following factors: (A) the present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. When making a listing or reclassification determination, we cannot consider impacts that may stem from the listing determination itself, and we cannot ignore threats for which there are no existing mitigation mechanisms (16 U.S.C. 1533(b), 50 CFR 424.11(b)). After considering the best scientific and commercial information available on status of the species and taking into account efforts being made to protect the species, we conclude that D. cylindrus is in danger of extinction and should be listed as endangered under the ESA.

Comment 5: We received a comment stating that there is a need for expanded and purposeful opportunities for states and territories with coral reefs in their jurisdiction to comment on, participate in, and lead efforts before the Federal government makes any decisions under the ESA, such as listing or reclassifying a species, and requesting that states and territories be consulted on which data are used as the best available science for informing decisions.

Response: The ESA and the implementing regulations describe the process NMFS must use when listing species under the ESA (16 U.S.C. 1533; 50 CFR part 424). This process includes giving actual notice of the proposed listing regulation to the state agency in each state in which the species is believed to occur and to each county or equivalent jurisdiction in which the species is believed to occur and inviting them to comment on the proposal (16 U.S.C. 1533(b)(5)(A)(ii); 50 CFR 424.16(c)(1)(ii)). In accordance with this requirement, we notified the states, counties, and territories where D. cylindrus is known to occur when we published the proposed rule to reclassify D. cylindrus as endangered. We accepted comments by standard mail, email, during the public hearing on September 26, 2023, and through the Federal eRulemaking portal. This allowed those government agencies the opportunity to participate in the decision to reclassify D. cylindrus as endangered, including providing input on the best scientific and commercial data available. We considered all relevant comments within the scope of this rulemaking received during the comment period when making this final determination to reclassify D. cylindrus from threatened to endangered.

We also note that we worked cooperatively with states and territories to obtain unpublished coral monitoring data to inform the 5-year review of ESA-listed Caribbean coral species. We considered the information in the 5-year review, including the population data obtained from the states and territories, when making the determination that D. cylindrus met the definition of an endangered species. By seeking unpublished monitoring data from states and territories, giving notice of the proposed listing regulation to states and territories in which the species occurs, and considering comments from states and territories, we provided opportunities for these groups to participate in the decision to change the status of D. cylindrus from threatened to endangered.

Comment 6: We received a comment that we should incorporate data from mesophotic reefs, which may serve as thermal refugia for shallow water species, into factors considered for listing and reclassifying species under the ESA.

Response: For the proposed rule to reclassify D. cylindrus to endangered, we evaluated the best scientific and commercial data available. As stated in the proposed rule, D. cylindrus inhabits most reef environments in depths between 1 and 25 meters (m) and is most common in reef environments in water depths between 5 and 15 m. We have found no evidence that D. cylindrus occurs at mesophotic depths (30-150 m), and the commenter did not provide any information to the contrary. Therefore, we did not consider the role of mesophotic reefs as a factor in the decision to change the status of D. cylindrus from threatened to endangered.

Comment 7: We received a comment asking if exporting dead samples of D. cylindrus for scientific research would require an ESA section 10(a)(1)(A) permit if they were collected prior to reclassification.

Response: If samples of D. cylindrus (alive, dead, or preserved) were collected prior to reclassification, an ESA section 10(a)(1)(A) permit is not needed to import or export them; rather, NMFS can issue a Letter of Determination to authorize import and export, provided certain criteria are met. In addition, D. cylindrus is listed on Appendix II of the Convention on International Trade in Endangered Species (CITES), and, therefore, a CITES export permit issued by the exporting country would be required. For more information on Letters of Determination, see https://www.fisheries.noaa.gov/permit/letter-determination-protected-species-parts-and-products. For more information on CITES, see https://www.fws.gov/international-affairs/cites.

Comment 8: We received a comment that it was unclear whether transport and transfer of captive D. cylindrus to another holding facility within the United States was a violation of the ESA section 9(a)(1) prohibitions and would require an ESA section 10(a)(1)(A) permit.

Response: Transportation of D. cylindrus or D. cylindrus parts within the United States is not a violation of the ESA section 9 prohibitions, provided that the corals were legally obtained and that the transport is not in the course of a commercial activity. Transfer of D. cylindrus between U.S. facilities is, therefore, allowable without the need for a NMFS ESA section 10(a)(1)(A) permit. Documentation of the transfer to a different holding facility should be maintained.

Comment 9: We received 2 comments that reclassification of D. cylindrus to endangered would have negative impacts on conservation efforts like restoration and rescue and cause delays, obstacles, and a greater administrative burden on restoration practitioners and state and territorial jurisdictions who would need to apply for an ESA section 10(a)(1)(A) permit. One of the commenters asked that NMFS minimize and streamline ESA section 10(a)(1)(A) permitting as much as possible to eliminate barriers to restoration and recovery. They recommended issuing a single permit to a state agency to authorize multiple practitioners to carry out restoration activities and developing a centralized database with online reporting that provides data access to all managing agencies.

Response: As explained in the response to Comment 4, listing and reclassification determinations must be made solely on the basis of the best available scientific and commercial information regarding a species' status and without reference to possible economic or other impacts of such determinations (16 U.S.C. 1533(b)(1)(A) and 50 CFR 424.11(b)). Thus, when making a listing or reclassification determination, we cannot consider whether the listing or reclassification will increase the administrative burden associated with applying for ESA permits for conservation activities.

NMFS is committed to making ESA section 10(a)(1)(A) permitting as clear and streamlined as possible within the bounds of the law. We will streamline the permitting process through several mechanisms, including issuing permits valid for up to 10 years, conducting programmatic consultation under section 7 of the ESA to eliminate the need for individual consultation on each permit application, and reprogramming the online application system, Authorizations and Permits for Protected Species (APPS) (see https://apps.nmfs.noaa.gov ) to accept applications for D. cylindrus. ESA section 10 Permit Holders can submit annual reports of their permitted activities in APPS. While these currently are not publically accessible in APPS, copies of submitted reports may be requested from the NMFS Office of Protected Resources, Permits and Conservation Division under the Freedom of Information Act. We are further recommending that individuals and groups that are working on the same project, at the same institution, or under the same funding to consider applying together to work under a single permit. These options allow for less frequent and reduced numbers of permit applications and can reduce processing times.

In anticipation of a final determination to reclassify D. cylindrus to endangered, we held webinars on April 16 and 19, 2024, to present information on the effects of a reclassification and the ESA section 10(a)(1)(A) permitting process. We announced the webinars to researchers and restoration practitioners known to work with D. cylindrus and agencies that issue research and restoration permits. We also announced these webinars on a coral listserv ( i.e., Coral List) to reach a broader audience. During the webinars, we included information on what activities would need an ESA permit should D. cylindrus be reclassified as endangered and how and when to submit an ESA permit application. We encouraged attendees to apply for an ESA permit before a final determination was made so that conservation activities could continue uninterrupted if a final rule went into effect. Additional permitting guidance can be found on our website at: https://www.fisheries.noaa.gov/species/pillar-coral/conservation-management.

We did not receive, nor did we find, data or references that presented substantial new information that would cause us to change our proposed listing determination. We received several sources of new information (see Comment 1), which provided population data that supported the information considered in the 5-year review report (NMFS, 2022) and proposed rule. We also received additional information related to threats ( e.g., ocean warming, ocean acidification, disease, sedimentation, and nutrient enrichment) which was consistent with or reinforced information in the 5-year review and proposed rule (see Comments 2 and 3). Therefore, while the new information contributed to our overall understanding of population dynamics and threats, it did not alter the outcome of the extinction risk analysis nor our interpretation of risk factors across the range of the species. Therefore, in this rule, we are finalizing the change in the classification of D. cylindrus from a threatened species to an endangered species under the ESA.

In response to questions received about ESA permits, we have added additional information to the Effects of Listing section of this final rule to clarify that a Letter of Determination is needed for import or export of D. cylindrus or D. cylindrus parts in possession before the reclassification takes effect. In consultation with our ESA permitting division, we also provide further clarification in the Effects of Listing section with respect to prohibited and non-prohibited activities. These clarifications include rephrasing some of the descriptions to focus on the activity rather than the impact to the species, rearranging or splitting the activities in the list to differentiate prohibited activities that would need an ESA section 10(a)(1)(A) permit from non-prohibited activities, and adding more detail to describe the particular prohibited and non-prohibited activities.

In the proposed rule to reclassify D. cylindrus from threatened to endangered under the ESA, we outlined the rationale for our determination. Below, we summarize our evaluation and final determination. We relied on the best scientific and commercial data available including the information in the 5-year review and the public comments received. Please refer to the proposed rule for additional information (88 FR 59494, August 29, 2023).

Dendrogyra cylindrus is a colonial coral that can form large pillars (up to 3 m) upon an encrusting base. It is a gonochoric ( i.e., separate sexes), broadcast spawning coral species, but some hermaphroditic colonies have been observed (Kabay, 2016; Neely et al., 2018; Neely et al., 2020a; O'Neil et al., 2021). Spawning observations have also suggested that eggs may be fertilized within female colonies prior to release (Marhaver et al., 2015). It has a relatively low annual egg production and low sexual recruitment, with no reports of observed sexual recruitment in the wild. Dendrogyra cylindrus can also reproduce asexually through fragmentation and reattachment to the substrate.

Dendrogyra cylindrus is present in the western Atlantic and throughout the greater Caribbean. It is absent in the Flower Garden Banks National Marine Sanctuary in the Gulf of Mexico and from the southwest Gulf of Mexico. It inhabits most reef environments in water depths ranging from 1 to 25 m and is most common in reef environments in water depths between 5 and 15 m. It has a naturally uncommon to rare occurrence, appearing as scattered, isolated colonies. It is sometimes found in highly clonal aggregations, likely resulting from fragmentation events (Chan et al., 2019).

Population trend information indicates the species has continued to decline since being listed in 2014. Surveys of D. cylindrus conducted in Colombia in 2012 show a reduced spatial extent, loss of colonies, and higher prevalence and amount of partial mortality 10 years after initial surveys (Bernal-Sotelo et al., 2019). Multiple thermal bleaching events in 2014 and 2015 and ongoing and emerging disease events (SCTLD) since 2014 have caused near extirpation of D. cylindrus in Florida (Jones et al., 2021; Lewis, 2018; Lewis et al., 2017; Neely et al., 2021a; Neely, 2024), and D. cylindrus is now considered functionally extinct ( i.e., the population is no longer viable and will not be able to sustain itself) along the Florida reef tract (Neely et al., 2021a).

Although quantitative population trend data are only available from Florida and Colombia, we assumed the species is in decline throughout most of its range based on the evidence from these regions (northern and southwestern portions of its range) and the more widespread evidence of severe disease impacts from SCTLD, which has spread from Florida to the eastern, western, and southern Caribbean (see https://www.agrra.org/coral-disease-outbreak/ for a map of confirmed sightings of SCTLD in the greater Caribbean). Dendrogyra cylindrus is highly susceptible to SCTLD (Florida Coral Disease Response Research & Epidemiology Team, 2018) and has been reported with high prevalence and confirmed or presumed mortality in multiple islands and countries across the Caribbean including the Bahamas (Dahlgren et al., 2021), Mexico (Alvarez-Filip et al., 2019; Alvarez-Filip et al., 2022; Estrada-Saldivar et al., 2021), and the U.S. Virgin Islands (Brandt et al., 2021; Costa et al., 2021). We assumed SCTLD will eventually reach all areas of the range of D. cylindrus based on its previous spread and the fact that it is waterborne (Aeby et al., 2019).

Dendrogyra cylindrus was listed as threatened in 2014 because of its susceptibility to and impacts from multiple threats, including ocean warming (ESA Factor E), disease (C), acidification (E), nutrient enrichment (A and E), sedimentation (A and E), trophic effects of fishing (A), and inadequate existing regulatory mechanisms to address global threats (D). As indicated in the proposed rule to reclassify D. cylindrus as endangered, these threats continue to contribute to the species' extinction risk. Several commenters provided additional information related to these threats, including ocean warming, ocean acidification, nutrient enrichment, sedimentation, and disease, which was consistent with the proposed rule and did not change our conclusions about any of these threats. Since its listing as threatened, D. cylindrus has declined in abundance and distribution in multiple locations with the most severe decline in the northern portions of its range. These declines are predominantly due to the effects of SCTLD, which emerged as a devastating and deadly new disease since the listing (Precht et al., 2016). Though the occurrence of D. cylindrus has historically been uncommon to rare, the species has become even rarer as a result of SCTLD. Furthermore, no observed sexual recruitment has been reported in the wild, and we concluded that reductions in population size and local extirpations will further inhibit the species' ability to persist and replenish diminished populations through asexual and sexual reproduction.

We evaluated conservation measures used to protect D. cylindrus, including treatment of individual colonies for SCTLD (Miller et al., 2020; Neely et al., 2020b; Neely et al., 2021c; O'Neil et al., 2018; Shilling et al., 2021; Walker et al. 2021), ex situ banking (Kabay, 2016; Neely et al., 2021b; Neely, 2024; O'Neil et al., 2021), and propagation of D. cylindrus for future restoration (Marhaver et al., 2015; Neely, 2019; Neely et al., 2020a; O'Neil et al., 2021; Villalpando et al., 2021). We concluded that the conservation actions would benefit the species but would not affect the status of D. cylindrus to the point at which listing as an endangered species is not warranted. Further, because current conservation actions do not directly address the root causes of threats such as disease, we concluded that they are insufficient to protect the species from the risk of extinction. See the proposed rule for additional discussion of conservation measures (88 FR 59497, August 29, 2023).

We reviewed the best scientific and commercial information available on the status of D. cylindrus, threats to the species, and conservation measures. Based on consideration of this information and public comments, we determine that D. cylindrus meets the definition of an endangered species. We find that D. cylindrus is in danger of extinction throughout all or a significant portion of its range. Dendrogyra cylindrus is susceptible to multiple threats including ocean warming (ESA Factor E), disease (C), acidification (E), nutrient enrichment (A and E), sedimentation (A and E), trophic effects of fishing (A), and inadequate existing regulatory mechanisms to address global threats (D). In addition, the following characteristics contribute to its risk of extinction:

(1) It is geographically located in the highly disturbed Caribbean where localized human impacts are high and threats are predicted to increase. A range constrained to this particular geographic area that is likely to experience severe and increasing threats indicates that a high proportion of the population of this species is likely to be exposed to those threats;

(2) It has an uncommon to rare occurrence throughout its range, which heightens the potential effect of localized mortality events and leaves the species vulnerable to becoming of such low abundance that it may be at risk from depensatory processes, environmental stochasticity, or catastrophic events;

(3) Its low sexual recruitment limits its capacity for recovery from threat-induced mortality events throughout its range; and

(4) It has experienced population declines, primarily due to SCTLD, in multiple locations throughout its range, including severe declines in the northern portion of its range, which has resulted in diminished distribution and local extirpation.

The combination of these characteristics indicates that D. cylindrus is in danger of extinction throughout its range and warrants listing as an endangered species due to factors A, C, D, and E.

Conservation measures provided for species listed as endangered or threatened under the ESA include recovery plans (16 U.S.C. 1553(f)), critical habitat designations, Federal agency consultation requirements (16 U.S.C. 1536), and prohibitions of certain acts under the ESA (16 U.S.C. 1538). Because D. cylindrus was previously listed as threatened, Federal agency consultation requirements are already in effect, and a recovery outline has been developed to guide recovery until a full recovery plan has been finalized. Critical habitat has also been designated for D. cylindrus (88 FR 54026, August 9, 2023).

All of the prohibitions in section 9(a)(1) of the ESA automatically apply to fish and wildlife listed as endangered species. Section 9(a)(1) includes prohibitions on importing, exporting, engaging in foreign or interstate commerce, or “taking” of the species. “Take” is defined under the ESA as “to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or an attempt to engage in any such conduct” (16 U.S.C. 1532(19)). These prohibitions apply to all persons subject to the jurisdiction of the United States, including in the United States, its territorial sea, or on the high seas. Upon the effective date of this rule to reclassify D. cylindrus as endangered, section 9 of the ESA would expressly prohibit the following:

(1) Taking of D. cylindrus within the United States or its territorial sea, or upon the high seas;

(2) Possessing, selling, delivering, carrying, transporting, or shipping any D. cylindrus that was illegally taken;

(3) Delivering, receiving, carrying, transporting, or shipping in interstate or foreign commerce any D. cylindrus in the course of a commercial activity;

(4) Selling or offering D. cylindrus for sale in interstate or foreign commerce; or

(5) Importing D. cylindrus into, or exporting D. cylindrus from, the United States.

On July 1, 1994, NMFS and the U.S. Fish and Wildlife Service (FWS) published a policy statement (59 FR 34272) that requires the agencies to identify, to the extent known at the time a species is listed, those activities that would or would not constitute a violation of section 9 of the ESA. The intent of this policy is to increase public awareness of the effect of a listing on proposed and ongoing activities within a species' range. Based on available information, we conclude the following categories of activities are likely to meet the ESA's definition of “take” and, therefore, result in a violation of the ESA section 9 prohibitions. We emphasize that whether a violation results from a particular activity is entirely dependent upon the facts and circumstances of each incident. The mere fact that an activity may fall within one of these categories does not mean that the specific activity will cause a violation. Further, an activity not listed may in fact result in a violation. Activities that are likely to result in a violation of section 9 prohibitions include, but are not limited to, the following:

(1) Collection of D. cylindrus, including colonies, fragments, tissue samples, and gametes, from the wild;

(2) Research outside the bounds of normal animal husbandry that results in harm ( e.g., injuring or killing) to captive D. cylindrus;

(3) Removing, relocating, or reattaching D. cylindrus in the wild;

(4) Damaging, poisoning, contaminating, or killing D. cylindrus;

(5) Scientific research activities on wild D. cylindrus involving the manipulation of the coral or its environment;

(6) Release of captive D. cylindrus into the wild. Release of a captive coral could have the potential to injure or kill the coral or to affect wild populations of D. cylindrus through introduction of disease;

(7) Habitat alternation, such as removal of substrate or alteration of water quality, resulting in injury or death of D. cylindrus;

(8) Discharging pollutants ( e.g., toxic chemicals, radioactive matter, carcinogens, mutagens, teratogens) or organic nutrient-laden water, including sewage water, into D. cylindrus habitat to an extent that harms or kills D. cylindrus;

(9) Shoreline and riparian disturbances (whether in the riverine, estuarine, marine, or floodplain environment) that may harm or kill D. cylindrus, for instance, by disrupting or preventing the reproduction, settlement, reattachment, development, or normal physiology of D. cylindrus. Such disturbances could include land development, run-off, dredging, and disposal activities that result in direct deposition of sediment on D. cylindrus, shading, or covering of substrate for fragment reattachment or larval settlement; and

(10) Activities that modify water chemistry in D. cylindrus habitat to an extent that disrupts or prevents the reproduction, development, or normal physiology of D. cylindrus.

Some categories of activities are unlikely to constitute a violation of the section 9 prohibitions. Again, we emphasize that whether a violation results from a particular activity is entirely dependent upon the facts and circumstances of each incident. The mere fact that an activity may fall within one of these categories does not mean that the specific activity will not cause a violation. We consider the following activities to be ones that are unlikely to violate the ESA section 9 prohibitions:

(1) Taking of wild D. cylindrus, including collection of colonies, fragments, tissue samples, and gametes, authorized by an ESA section 10(a)(1)(A) permit issued by NMFS for the purposes of scientific research or the enhancement of propagation or survival of the species and carried out in accordance with the terms and conditions of the permit;

(2) Incidental taking of D. cylindrus resulting from federally authorized, funded, or conducted projects for which consultation under section 7 of the ESA has been completed and when the project is conducted in accordance with any terms and conditions set forth by NMFS in an incidental take statement in a biological opinion pursuant to section 7 of the ESA;

(3) Import or export of D. cylindrus or D. cylindrus parts authorized by a CITES permit and an ESA section 10(a)(1)(A) permit (or Letter of Determination for D. cylindrus or D. cylindrus parts in possession before the reclassification takes effect) issued by NMFS;

(4) Continued possession of D. cylindrus parts or live D. cylindrus that were in captivity at the time of up-listing to an endangered species, including any progeny produced from captive corals after the rule is finalized, so long as the prohibitions of ESA section 9(a)(1) are not violated. Corals are considered to be in captivity if they are maintained in a controlled environment or under human care in ocean-based coral nurseries. Individuals or organizations should be able to provide evidence that D. cylindrus or D. cylindrus parts were in captivity prior to its listing as an endangered species. We suggest such individuals or organizations submit information to us on the D. cylindrus in their possession ( e.g., type, number, size, source, date of acquisition), to establish their claim of possession (see FOR FURTHER INFORMATION CONTACT );

(5) Providing normal care for captive D. cylindrus. Captive corals are still protected under the ESA and may not be killed or injured or otherwise harmed and must receive proper care. Normal husbandry care of captive corals includes handling, cleaning, maintaining water quality within an acceptable range, extracting tissue samples for the purposes of diagnosis of condition or genetics, treating or preventing spread of maladies such as disease or parasites using established methods proven to be effective, propagating corals by sexual or asexual means ( i.e., fragmenting larger coral colonies into smaller colonies to increase the number of corals, maintain corals of manageable size, or accelerate their growth rate) within the bounds of normal husbandry practices, attaching to artificial surfaces, and removing dead skeleton. Scientific studies that are intended to improve the husbandry practices of caring for captive D. cylindrus, where there is a reasonable expectation that they would not cause harm to D. cylindrus ( e.g., trialing new food supplements, comparing different lighting systems, testing different attachment substrates), would not require an ESA permit;

(6) Interstate and intrastate transportation of legally obtained captive D. cylindrus and D. cylindrus parts provided it is not in the course of a commercial activity. If captive corals or D. cylindrus parts are to be moved to a different holding location, records documenting transfer of corals should be maintained;

(7) Stabilization of loose or unattached D. cylindrus, including fragments, in the wild by experienced individuals and as authorized by an ESA section 10(a)(1)(A) permit issued by NMFS;

(8) Relocation of wild D. cylindrus from one site to another under the authorization of an ESA section 10(a)(1)(A) permit issued by NMFS;

(9) Use of captive D. cylindrus for scientific studies under the authorization of an ESA Section 10(a)(1)(A) permit issued by NMFS. Scientific studies that have the potential to injure or harm captive D. cylindrus ( e.g., altered temperature outside of ideal range, exposure to contaminants, potentially harmful chemicals, or disease, introduction of coral predators) require an ESA section 10(a)(1)(A) permit;

(10) Research activities that involve collection or manipulation of D. cylindrus in the wild under the authorization of an ESA section 10(a)(1)(A) permit;

(11) Observational studies on D. cylindrus in the wild that do not involve collection or manipulation of D. cylindrus such as benthic surveys, photographs, and videos;

(12) Release of captive D. cylindrus into the wild, as authorized by an ESA section 10(a)(1)(A) permit issued by NMFS; and

(13) Treatment of wild D. cylindrus for disease by experienced individuals using non-experimental methods proven to be effective and as authorized by state and territorial permits.

In December 2004, the Office of Management and Budget (OMB) issued a Final Information Quality Bulletin for Peer Review establishing minimum peer review standards, a transparent process for public disclosure of peer review planning, and opportunities for public participation. The OMB Peer Review Bulletin (the Bulletin), implemented under the Information Quality Act (Pub. L. 106-554), is intended to enhance the quality and credibility of the Federal Government's scientific information and applies to influential or highly influential scientific information disseminated on or after June 16, 2005. To satisfy our requirements under the Bulletin, the proposed rule was subject to peer review. A peer review plan was posted on the NOAA peer review agenda and can be found at: https://www.noaa.gov/information-technology/endangered-species-act-proposed-rule-for-pillar-coral-dendrogyra-cylindrus-id432. Our synthesis and assessment of scientific information supporting the proposed action was peer reviewed via individual letters soliciting the expert opinions of three qualified specialists selected from the academic and scientific community. The charge to the peer reviewers and the peer review report have been placed in the administrative record and posted on the agency's peer review agenda. In meeting the OMB Peer Review Bulletin requirements, we have also satisfied the requirements of the 1994 joint U.S. Fish and Wildlife Service/NMFS peer review policy (59 FR 34270; July 1, 1994).

A complete list of the references used in this rule is available online (see www.fisheries.noaa.gov/species/pillar-coral#conservation-management ) and upon request (see FOR FURTHER INFORMATION CONTACT ).

The 1982 amendments to the ESA, in section 4(b)(1)(A), restrict the information that may be considered when assessing species for listing. Based on this limitation of criteria for a listing decision and the opinion in Pacific Legal Foundation v. Andrus, 675 F. 2d 825 (6th Cir. 1981), NMFS has concluded that ESA listing actions are not subject to the environmental assessment requirements of the National Environmental Policy Act (NEPA).

As noted in the Conference Report on the 1982 amendments to the ESA, economic impacts cannot be considered when assessing the status of a species. Therefore, the economic analysis requirements of the Regulatory Flexibility Act are not applicable to the listing process.

This final rule is exempt from review under Executive Order 12866.

This final rule does not contain a collection-of-information requirement for the purposes of the Paperwork Reduction Act.

In accordance with Executive Order 13132, agencies are required to take into account any federalism impacts of regulations under development. This Executive order includes specific consultation directives for situations where a regulation will preempt state law or impose substantial direct compliance costs on state and local governments (unless required by statute). Neither of those circumstances is applicable to this final listing determination. In keeping with the intent of the Administration and Congress to provide continuing and meaningful dialogue on issues of mutual state and Federal interest, the proposed rule was provided to the relevant agencies in each state in which the subject species occurs, and these agencies were invited to comment. Their comments were addressed with other comments in the Public Comments and Our Responses section.

Executive Order 12898 requires that Federal actions address environmental justice in the decision-making process. In particular, the environmental effects of the actions should not have a disproportionately high and adverse effect on the health or environment of minority and low-income populations. The purpose of this rule is to update the classification of a coral species that is already protected under the ESA. This rule will serve to continue the protection and conservation of this coral species and is expected to promote a healthy ecosystem. Therefore, this rule is not expected to have a disproportionately high or adverse effect on the health or the environment of minority populations or low-income populations.

For the reason set out in the preamble, we amend 50 CFR parts 223 and 224 as follows: