The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain serial-numbered Pilatus Model PC-12, PC-12/45, PC-12/47, and PC-12/47E airplanes. The NPRM published in the Federal Register on February 27, 2023 (88 FR 12273). The NPRM was prompted by AD 2022-0212, dated October 18, 2022 (referred to after this as “the MCAI”), issued by the European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union.

The MCAI was prompted by a reported occurrence of a burning odor coming from the air conditioning vents during the climb phase of a Pilatus Model PC-12/47E airplane. An investigation identified that insufficient grounding of the VCCS compressor/condenser at frame 37 resulted in severe heat damage to the baseplate and adjacent metal support structure. It was determined that this condition may occur on airplanes equipped in production with the large oxygen bottle installed on the right-hand side of the rear fuselage. To address the unsafe condition, the MCAI requires a one-time inspection of the power return and chassis grounding cable attachment point at frame 37, including the attachment parts, and modification of the installation of the VCCS.

In the NPRM, the FAA proposed to require a one-time inspection of the power return and chassis grounding cable attachment point at frame 37, including the attachment parts, and modification of the installation of the VCCS. This condition, if not addressed, could, in the case of damage to the oxygen supply line, lead to an uncontrolled fire with damage to the airplane and injury to the occupants. The FAA is issuing this AD to address the unsafe condition on these products.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2023-0421.

The FAA received a comment from the Air Line Pilots Association, International (ALPA), who supported the NPRM without change. In addition, an individual commenter submitted a comment to the docket, but did not comment on the proposed required actions or the determination of the costs in the NPRM.

These products have been approved by the aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data, considered the comment received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, this AD is adopted as proposed in the NPRM.

The FAA reviewed Pilatus PC-12 Service Bulletin 21-016, dated August 15, 2022, which specifies procedures for inspecting the power return and chassis grounding cable attachment point on the airframe at frame 37, including the attachment parts, modifying the installation of the VCCS compressor/condenser power return cables, and installing an additional isolated VCCS chassis ground cable. This service bulletin also specifies contacting Pilatus if any damage is found.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in ADDRESSES .

The MCAI requires contacting the manufacturer for approved corrective action instructions if any discrepancy is found during the inspection. This AD requires contacting either the Manager, International Validation Branch, FAA; EASA; or Pilatus's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.

The FAA estimates that this AD affects 8 airplanes of U.S. registry.

The FAA estimates the following costs to comply with this AD:

The repair instructions that may be needed as a result of the inspection could vary significantly from airplane to airplane. The FAA has no data to determine the costs to accomplish the repair or the number of airplanes that would need this repair.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will 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.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The Delaware River Basin Commission (“DRBC” or “Commission”) is a Federal-interstate compact agency charged with managing the water resources of the Delaware River Basin on a regional basis without regard to political boundaries. Its members are the governors of the four basin states—Delaware, New Jersey, New York and Pennsylvania—and on behalf of the federal government, the North Atlantic Division Commander of the U.S. Army Corps of Engineers.

In accordance with 18 CFR 401.43(c), on July 1 of every year, the Commission's regulatory program fees as set forth in tables 1, 2 and 3 of that section are subject to an annual adjustment, commensurate with any increase in the annual April 12-month Consumer Price Index (CPI) for Philadelphia published by the U.S. Bureau of Labor Statistics during that year. Pursuant to 18 CFR 420.41(c), the same indexed adjustment applies to the Commission's schedule of water charges for consumptive and non-consumptive withdrawals of surface water within the basin. The referenced April 12-month CPI for 2023 showed an increase of 4.74%. Commensurate adjustments are thus required.

This notice is made in accordance with 18 CFR 401.43(c) and 18 CFR 420.41(c), which provide that a revised fee schedule will be published in the Federal Register by July 1. The revised fees also may be obtained by contacting the Commission during business hours or by checking the Commission's website.

For the reasons set forth in the preamble, the Delaware River Basin Commission amends parts 401 and 420 of title 18 of the Code of Federal Regulations as set forth below:

This document and additional information concerning OFAC are available on OFAC's website: www.treas.gov/ofac.

On May 5, 2023, OFAC issued GL 8G to authorize certain transactions otherwise prohibited by the Russian Harmful Foreign Activities Sanctions Regulations, 31 CFR part 587. GL 8G was made available on OFAC's website ( www.treas.gov/ofac ) when it was issued. The text of this GL is provided below.

The Coast Guard will enforce the safety zone in 33 CFR 165.786, Table to § 165.786, Item 6.2, for the 47th Annual Swim Around Key West from 6 a.m. until 4 p.m. on June 3, 2023. This action is being taken to provide for the safety of life on navigable waterways during this event. The regulation for recurring marine events within Sector Key West Captain of the Port (COTP) zone, 165.786, Table to § 165.786, Item 6.2, specifies the location of the regulated area. During the enforcement period, no person or vessel may enter, transit through, anchor in, or remain within the established regulated areas without approval from the Captain of the Port Key West or designated representative. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.

The Coast Guard will provide notice of the regulated area by Local Notice to Mariners and Broadcast Notice to Mariners. If the Captain of the Port Key West determines that the regulated area need not be enforced for the full duration stated in this publication, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area.

The Coast Guard will enforce the safety zone in 33 CFR 165.786, Table to § 165.786, Item 6.1, for the College of the Florida Keys Swim Around Key West from 8:30 a.m. until 4:30 p.m. on June 17, 2023. This action is being taken to provide for the safety of life on navigable waterways during this event. The regulation for recurring marine events within Sector Key West Captain of the Port (COTP) zone, 165.786, Table to § 165.786, Item 6.1, specifies the location of the regulated area. During the enforcement period, no person or vessel may enter, transit through, anchor in, or remain within the established regulated areas without approval from the Captain of the Port Key West or designated representative. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.

The Coast Guard will provide notice of the regulated area by Local Notice to Mariners and Broadcast Notice to Mariners. If the Captain of the Port Key West determines that the regulated area need not be enforced for the full duration stated in this publication, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area.

Purpose of Program: A purpose of the Activities for Underserved Populations program is to make awards to minority entities and Indian Tribes to conduct research, training, technical assistance, or a related activity to improve the quality, access, delivery of services, and competitive integrated employment outcomes under the Rehabilitation Act, especially for individuals with disabilities from underserved populations. As defined in section 21(b)(5) of the Rehabilitation Act, “minority entity” means “a historically Black college or university, a Hispanic-serving institution of higher education, an American Indian Tribal college or university, or another institution of higher education whose minority student enrollment is at least 50 percent.” The definition of “Indian Tribe” in section 7(19)(B) of the Rehabilitation Act is “any Federal or State Indian tribe, band, rancheria, pueblo, colony, or community, including any Alaskan native village or regional village corporation (as defined in or established pursuant to the Alaska Native Claims Settlement Act) and a Tribal organization (as defined in section 4(l) of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450b(l)).”

Program Authority: 29 U.S.C. 718(b)(2)(B).

We published a notice of proposed priority and definition (NPP) for this program in the Federal Register on February 8, 2023 (88 FR 8242). That document contained background information and our reasons for proposing the priority and definition.

There are no differences between the NPP and this notice of final priority and definition (NFP), as discussed in the Analysis of Comments and Changes section of this document.

Public Comment: In response to our invitation in the NPP, eight parties submitted comments on the proposed priority and definition. Generally, we do not address technical and other minor changes or suggested changes the law does not authorize us to make under the applicable statutory authority. In addition, we do not address general comments that raised concerns not directly related to the proposed priority and definition.

Analysis of Comments and Changes: An analysis of the comments and of any changes in the priority since publication of the NPP follows.

Comment: One commenter commended the Department for including Indian Tribes in the definition of “underserved populations” and shared that it demonstrates a tangible effort to expand opportunities for Indian Tribes and is a step forward in repairing and building trust with the Tribes. Another commenter agreed that the priority would strengthen the delivery of services to individuals with disabilities from underserved populations.

Discussion: The Department appreciates support for this priority.

Changes: None.

Comment: One commenter expressed opposition to the proposed priority, stating that by exclusively focusing on or prioritizing awards to minority entities and Indian Tribes as described in 29 U.S.C. 718(b)(2)(B), the priority limits the entities described in 29 U.S.C. 718(b)(2)(C), which permits awards to a State or public or private nonprofit agency or organization to provide outreach and technical assistance to minority entities and Indian Tribes in order to increase their participation in activities carried out under the Rehabilitation Act and enhance their capacity to do so. The commenter asserted that awards should be granted based on the best possible outcome, not the race or ethnicity of the applicant.

Discussion: The proposed priority and definition are directly aligned with the program statute. Section 21 of the Rehabilitation Act (29 U.S.C. 718(b)(2)(A-C)) establishes three allowable activities for this program and the entities eligible to receive awards for each of the allowable activities. The Department has provided funding opportunities under each of the allowable activities at different times since this program was authorized, including section 718(b)(2)(C). For this funding opportunity, as described in the NPP, the Department determined that there was a need for the activities authorized by section 718(b)(2)(B). The Department further determined that this priority and definition align with such activities, as well as the Secretary's Supplemental Priorities and Definitions for Discretionary Grant Programs, published in the Federal Register on December 10, 2021 (86 FR 70612), and Executive Order 13985 for Advancing Racial Equity and Support for Underserved Communities Through Federal Government, published in the Federal Register on January 20, 2021 (86 FR 7009).

Changes: None.

Comment: One commenter recommended that the priority include targeted research and interventions in educational settings for Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders, and other persons of color who identify as LGBTQ+. The commenter noted that LGBTQ+ youth of color experience higher rates of homelessness and poverty and should be included in the priority.

Discussion: We appreciate the recommendation for including targeted research and interventions in educational settings in the priority for Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders, and other persons of color who identify as LGBTQ+. However, the purpose of the priority is to improve the delivery of State vocational rehabilitation (VR) services to individuals with disabilities from underserved populations with the goal of improving competitive integrated employment outcomes. The Department anticipates that the training and technical assistance provided to State VR agencies through this priority will ultimately benefit Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders, and other persons of color, who are individuals with disabilities, including those who identify as LGBTQ+.

Changes: None.

Comment: One commenter stated that the priority should provide an avenue for minority-serving institutions to train pre-service students and build the capacity of future VR counselors to effectively serve underserved populations. The commenter also suggested that additional strategies are needed to build a critical mass of skilled researchers at minority-serving institutions to study long-term inequities in employment experienced by individuals with disabilities from underserved populations. The commenter also inquired if applicants could propose activities to build a pipeline at minority-serving institutions to train and mentor students as future research leaders who could generate novel knowledge that informs service intervention and policy innovation for reducing employment disparities among individuals with disabilities from underserved populations.

Discussion: The Department believes that pre-service training is essential to improving VR services to, and competitive integrated employment outcomes of, individuals with disabilities from underserved populations. As stated in the priority, applicants are required to disseminate training and technical assistance material, analysis of data collected, evidence-based and promising practices, and lessons learned to RSA-funded Rehabilitation Long-Term Training projects designed to provide pre-service training, as well as RSA-funded technical assistance centers, Department-funded programs, and Federal partners, as applicable. In addition, applicants must develop products, such as toolkits, guides, manuals, webinars, and communities of learning for instructors, facilitators, State VR agency directors, and human resource and professional development specialists to facilitate the implementation of training and technical assistance material in curriculum and relevant training and development activities.

The Department also agrees that research focused on inequities in employment for individuals with disabilities from underserved populations, and encouraging students at minority entities to engage in such research, could help the VR system better enable individuals with disabilities from underserved populations to access VR resources, secure competitive integrated employment, and reach future goals. To that end, the priority requires the grantee to contribute to VR research and pedagogical practices that promote access to approaches that are racially, ethnically, culturally, and linguistically inclusive. Further, as described in paragraph (c)(iv) of the Application Requirements, under “Quality of Project Services,” applicants may include any other training and technical assistance activity that improves understanding, responsiveness, and delivery of services to, and competitive integrated employment outcomes for, underserved populations. For example, applicants may propose an activity at a minority entity to train and mentor students who could generate new knowledge that informs service intervention and policy innovation for reducing employment disparities among individuals with disabilities from underserved populations. However, activities included under paragraph (c)(iv) should not be the entire focus of the project, since the applicant must propose a project that, at a minimum, provides direct training and technical assistance to VR agencies by conducting all of the activities described under Application Requirements, paragraphs (a) through (f) in a culturally appropriate manner.

Changes: None.

Comment: One commenter recommended that the Department also target vulnerable populations such as English learners and individuals living in rural or remote communities under this priority. The commenter added that underserved and vulnerable populations often experience disproportionate outcomes.

Discussion: The Department agrees with the commenter that English learners and individuals living in rural or remote communities have experienced inequities that have limited or prevented their ability to achieve competitive integrated employment; however, the program authority under which the funding is appropriated is based on congressional findings regarding the inequitable treatment of individuals from minority backgrounds in the VR process, and the statute instructs the Secretary to concentrate on improving the outcome of services provided under the Rehabilitation Act to individuals from minority backgrounds. 29 U.S.C. 718 (Section 21, “Traditionally Underserved Populations”). Therefore, in order to comply with statutory requirements, this priority focuses its definition of “underserved populations” on individuals from minority backgrounds: “Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders, and other persons of color.” While such underserved populations will likely include some English learners and individuals from rural or remote areas, they are not specifically included in the target population due to the statutory focus on individuals from minority backgrounds in this particular funding opportunity. However, under the priority, the grantee must contribute to VR research and pedagogical practices that promote access to approaches that are racially, ethnically, culturally, and linguistically inclusive.

Changes: None.

Comment: One commenter recommended that we clearly define short- and long-term goals in the priority. The commenter raised concerns about the five-year performance period and proposed that the priority set intervals for evaluating the effectiveness of the training and technical assistance that the grantee is providing to the identified State VR agencies. The commenter added that the Delphi method (a term generally used to describe a structured, iterative survey or feedback process to elicit and combine expert opinion to reach consensus) could help analyze different phases of development.

Discussion: The Department appreciates the commenter's concerns and suggestions. The Department notes that, under paragraph (d) of the Application Requirements, “Quality of the Project Evaluation,” applicants must include an evaluation plan for the project that includes such periodic review. The plan must describe a process or approach that will be used for gathering feedback from the identified State VR agencies throughout years two, three, four, and five of the project for continuous improvement and to evaluate the effectiveness of the training and technical assistance provided to a minimum of 15 State VR agencies. Additionally, under paragraph (d)(3), applicants must describe methodologies, including instruments, data collection methods, and analyses, that will be used to evaluate the project and how the methods of evaluation will produce quantitative and qualitative data to demonstrate whether the project activities achieved their intended outcomes. Applicants may propose the Delphi method or other appropriate methods to meet this requirement.

Changes: None.

Comment: One commenter responded to the Department's directed questions about the requirement for applicants to provide technical assistance to a minimum of 15 State VR agencies (Combined, General, or Agencies for the Blind) over a five-year period. The commenter spoke to how the requirement of providing technical assistance to a minimum of 15 State VR agencies may deter Indian Tribes from applying for this funding opportunity. The commenter recommended lowering the requirement from a minimum of 15 State VR agencies to five because of limited Tribal operating budgets, the rural location of many Tribes, andchanges in program staff resulting from Tribal elections. As it applies to Tribes located in Montana and the Rocky Mountain and Great Plains regions, the commenter explained that the minimum requirement may discourage Tribes from the funding opportunity altogether. The commenter indicated that Tribes in Montana operate under very limited budgets to meet the respective needs of the people they serve, and that providing training and technical assistance to a minimum of 15 State VR agencies over five years will likely contribute to additional budget constraints and concerns. The commenter added that it would also be difficult for Tribes in these regions to host or coordinate 15 trainings as Indian Reservations can be hundreds of miles from the neighboring county seat. Additionally, the commenter shared that Tribal elections could result in a change in the program applicant or program coordinator within the five-year grant period, particularly in Montana, where most Tribes hold elections every two years.

Discussion: We appreciate the commenter's concerns about the capability of Indian Tribes located in rural areas to successfully provide training and technical assistance to a minimum of 15 State VR agencies over a five-year performance period, including concerns about limited operating budgets and changes in Tribal government leadership. There are currently 78 VR agencies (34 Combined VR agencies, 22 General VR agencies, and 22 Blind VR agencies) and 93 Tribal VR programs. In addition, the Department funds the American Indian Vocational Rehabilitation Training and Technical Assistance Center and Tribal VR Institute (AIVRTTAC), which assists Tribal governments to develop or to increase their capacity to provide a program of vocational rehabilitation services, in a culturally relevant manner, to American Indians with disabilities residing on or near Federal or State reservations. The program's goal is to enable these individuals, consistent with their individual strengths, resources, priorities, concerns, abilities, capabilities, and informed choice, to prepare for and engage in gainful employment. Program services are provided under an individualized plan for employment and may include native healing services. The AIVRTTAC ensures that all materials and activities are culturally responsive through providing culturally responsive teaching, researching needs assessments, including examining and developing culturally based promising VR practices, assisting AIVRTTAC participants in adapting standard VR practices to the cultural and social needs of AIVRS projects, using the AIVRTTAC holistic AIVRS project model, and developing opportunities to bridge understanding between cultures. The Department identified a minimum number of State VR agencies based on factors such as cost, level of effort, scope of the project, duration of the training and technical assistance, and the unique challenges and demographics of State VR agencies. We note that the grantee may offer training and technical assistance in-person and remotely to the identified State VR agencies. The grantee may also determine how many State VR agencies to serve each year over a five-year period to meet the minimum requirement. In addition, applicants may subgrant to Indian Tribes to directly carry out project activities described in the priority, as stated in the notice inviting applications published elsewhere in this issue of the Federal Register .

In addition to these factors, the Department also recognizes the financial constraints of Indian Tribes, especially those located in rural areas, may be a potential barrier to applying for this competition. Therefore, the Department will expand the range of State VR agencies the grantee must serve in the Final Priority from 15 to a minimum range of 5 to 15 to ensure all applicants have an opportunity to successfully meet the goals of this program. When determining a minimum range of State VR agencies to serve, applicants should consider the estimated available funds described in the notice inviting applications published elsewhere in the Federal Register . Given the Department only plans to award one grant, applicants are encouraged to identify a meaningful number of State VR agencies to receive training and technical assistance from this project in order to increase competitive integrated employment outcomes for individuals with disabilities from underserved populations.

Changes: In the Final Priority, the Department provides funding for a cooperative agreement for a minority entity or an Indian Tribe to provide training and technical assistance to a minimum range of 5 to 15 State VR agencies (Combined, General, or Agencies for the Blind) over a five-year period of performance.

Comment: One commenter recommended that individuals with 8(a) certification (socially and economically disadvantaged small businesses) be included as eligible applicants.

Discussion: We appreciate the comment. However, for-profit entities, including small businesses, are not eligible applicants under 29 U.S.C. 718(b)(2)(B).

Changes: None.

Improving the Delivery of Vocational Rehabilitation Services to, and the Employment Outcomes of, Individuals with Disabilities from Underserved Populations.

Under this priority, the Department provides funding for a cooperative agreement for a minority entity or an Indian Tribe to provide training and technical assistance to a minimum range of 5 to 15 State VR agencies (Combined, General, or Agencies for the Blind) over a five-year period of performance so that the agencies are equipped to serve as role models for diversity, equity, inclusion, and accessibility in the workforce system by implementing policies, practices, and service delivery approaches that are designed to contribute to increasing competitive integrated employment outcomes for individuals with disabilities from underserved populations. Further, the grantee must contribute to VR research and pedagogical practices that promote access to approaches that are racially, ethnically, culturally, and linguistically inclusive.

During the first year of the project the grantee will focus on developing training and technical assistance material and gathering input and feedback from a diverse group of stakeholders including the Rehabilitation Services Administration (RSA), State VR agencies, and other relevant partners. During the period of performance, the grantee must enter into agreements with the State VR agencies receiving training and technical assistance. Each agreement must: specify the level of involvement from VR agency leadership and personnel and include an assurance that the VR agency is committed to sustainable systems change across the organization for improving delivery of services to underserved populations; explain how data will be collected and shared; identify training and technical assistance needs, intervention strategies, and implementation timelines; and describe how outcomes will be measured. The grantee must have a minimum of two agreements in place by the end of the first year of the grant.

To be considered for funding under this priority, applicants must, at a minimum, propose a project that will conduct the following activities in a culturally appropriate manner. The Department encourages innovative approaches to meet this requirement. To meet this requirement, applicants must—

(a) Demonstrate, in the narrative section of the application under “Significance of the Proposed Project,” an understanding of the inequities and challenges experienced by individuals with disabilities from underserved populations determined eligible to receive VR services. To meet this requirement, applicants must—

(1) Present information and relevant data about the disparities that exist with respect to VR services and employment outcomes for underserved populations; and

(2) Describe how the project proposes to improve VR services for, and competitive integrated employment outcomes of, underserved populations.

(b) Demonstrate, in the narrative section of the application under “Quality of Project Design,” how the project will address inequities and challenges experienced by underserved populations determined eligible to receive VR services. To meet this requirement, applicants must—

(1) Demonstrate knowledge and experience working with individuals with disabilities from underserved populations;

(2) Incorporate into the project design current research and promising and evidence-based practices (EBPs), 1 research about adult learning principles and implementation science, and relevant findings, recommendations, and relevant strategies identified by the Targeted Communities project  2 to overcome barriers to competitive integrated employment and VR participation for individuals with disabilities from underserved populations;

(3) Detail how the project will collect and examine data, including from the RSA-911 and other relevant sources, from a minimum range of 5 to 15 State VR agencies regarding VR applicants, VR-eligible individuals, and VR participants by race/ethnicity by—

(i) Exploring patterns, changes, or shifts in demographics for individuals with disabilities from underserved populations;

(ii) Exploring data, by race/ethnicity, from each State VR agency regarding VR applicants to identify opportunities for increased outreach to and referral of individuals with disabilities from underserved populations to VR services;

(iii) Examining data, by race/ethnicity, from each State VR agency regarding selected VR services and competitive integrated employment outcomes at exit to identify inconsistencies or gaps in the provision of services;

(iv) Examining data from each State VR agency to identify reasons for successful and unsuccessful closures between VR program participants from underserved populations and VR program participants who are not from underserved populations; and

(v) Reviewing each State VR agency's service delivery model from eligibility determination to exit; and

(4) Present approaches for how the information and data described above will be used to inform strategies to improve the delivery of services to individuals with disabilities from underserved populations for each of the identified State VR agencies. For example, applicants may consider conducting a needs assessment and asset map for each of the identified State VR agencies to identify existing programs and services and businesses and philanthropic organizations in the community, as well as potential gaps and opportunities for collaboration, to support individuals with disabilities from underserved populations in successfully obtaining competitive integrated employment. Applicants may also consider designing a long-term data collection tool and provide analytical support and training to the identified State VR agencies to identify additional data elements not captured in the RSA-911 or other case management systems to continually assess the quality of services and outcomes for individuals with disabilities from underserved populations and individuals with disabilities not from underserved populations.

(c) Demonstrate, in the narrative section of the application under “Quality of Project Services,” how the project will be designed so that policies, practices, and service delivery approaches will contribute to increased competitive integrated employment outcomes for individuals with disabilities from underserved populations. To meet this requirement, applicants must—

(1) Propose training and technical assistance activities that will be offered to the identified State VR agencies. Training and technical assistance activities will be further developed during the first year of the grant and described in the agreements with the identified State VR agencies based on needs and analysis of data. Training and technical assistance activities may include, but are not limited to, (i) assisting in State VR agency coordination and cross-agency partnerships with State and local agencies and community-based organizations, workforce programs, educational institutions, and other relevant local community agencies and organizations ( i.e., agencies and organizations that provide services and supports related to mental health, substance use, behavioral health, intellectual developmental disabilities, and other areas of need such as housing, food, transportation, and healthcare) to strengthen outreach and awareness about VR programs and services, build trust between State VR agency counselors and individuals with disabilities from underserved populations, and connect individuals with disabilities from underserved populations determined to be VR eligible with necessary supports to successfully obtain competitive integrated employment; (ii) reviewing policies, practices, and procedures from the identified State VR agencies and providing recommendations to help ensure they are culturally appropriate and implemented in an appropriate manner; (iii) developing strategies to strengthen diversity in the VR workforce ( e.g., reviewing hiring practices from the identified State VR agencies and identifying strategies that expand outreach to VR counselors from underserved populations and mentoring and coaching activities for new and existing VR counselors and paraprofessionals, human resource and professional development specialists, and VR management and leadership personnel from underserved populations); and (iv) any other activity that improves understanding, responsiveness, and delivery of services to, and competitive integrated employment outcomes for, individuals with disabilities from underserved populations;

(2) Detail how those activities will incorporate relevant strategies and promising and effective practices identified by the Targeted Communities Project and other EBPs or related sources to the extent possible;

(3) Explain how training and technical assistance activities will be of high quality and sufficient intensity and duration to achieve the intended outcomes of the project;

(4) Describe how remote learning  3 opportunities will be incorporated into the project. Remote learning opportunities should offer experiences that advance engagement and implementation ( e.g., synchronous and asynchronous professional learning, professional learning networks or communities, and coaching), which could also be incorporated into Rehabilitation Counseling programs, as well as other training and professional development activities designed for the VR workforce, as appropriate. The remote learning environment must be accessible to individuals with disabilities in accordance with Section 504 of the Rehabilitation Act of 1973;

(5) Describe their knowledge, skills, and experience to support the training and technical assistance activities described above;

(6) Describe how the project will contribute to VR research and pedagogical practices that promote access to approaches that are racially, ethnically, culturally, and linguistically inclusive. To meet this requirement, applicants must describe how they will—

(i) Disseminate to all State VR agencies, RSA-funded Rehabilitation Long-Term Training projects and technical assistance centers, Department-funded programs, and Federal partners, as applicable, training and technical assistance material, analysis of data collected, evidence-based and promising practices, and lessons learned;

(ii) Develop products, such as toolkits, guides, manuals, webinars, and communities of learning, for instructors, facilitators, State VR agency directors, and human resource and professional development specialists to facilitate the implementation of training and technical assistance material in curriculum and relevant training and development activities; and

(iii) Gather input and feedback from a diverse group of stakeholders and subject matter experts, including RSA, State VR agencies, and other relevant partners, throughout the project to inform the development and delivery of the material described above.

(d) In the narrative section of the application under “Quality of the Project Evaluation,” include an evaluation plan for the project. The evaluation plan must describe—

(1) Clear and measurable outcomes;

(2) Approaches for measuring the effectiveness of the intervention strategies identified in the agreements, including standards and targets for measuring knowledge, skills, and abilities of State VR agency personnel before and after completion of training activities. To address this requirement, applicants must provide an approach for determining—

(i) The most effective practices in improving the delivery of services to individuals with disabilities from underserved populations and the data that demonstrate the effectiveness of the practices; and

(ii) The most effective practices in creating a culture of systems change within the State VR agency and the data that demonstrate the effectiveness of the practices;

(3) Methodologies, including instruments, data collection methods, and analyses, that will be used to evaluate the project and how the methods of evaluation will produce quantitative and qualitative data to demonstrate whether the project activities achieved their intended outcomes;

(4) How the evaluation will be coordinated, implemented, and revised, as needed, during the project. The applicant must designate at least one individual with sufficient dedicated time, demonstrated experience in evaluation, and knowledge of the project to coordinate and conduct the evaluation. This may include, but is not limited to, making revisions to reflect any changes or clarifications, as needed, to the model and to the evaluation design and instrumentation with the logic model ( e.g., designing instruments and developing quantitative or qualitative data collections that permit collecting of progress data and assessing project outcomes);

(5) How evaluation results will be used to improve delivery of services to VR program participants from underserved populations from eligibility determination to exit. To address this requirement, applicants must provide an approach to gather input and feedback that includes the experiences of VR program participants from underserved populations. Applicants may consider voluntary focus groups, use of a unique identifier, or another approach that adheres to consumer confidentiality requirements in 34 CFR 361.38; and

(6) A process for gathering feedback from the identified State VR agencies for continuous improvement throughout years two, three, four, and five of the project.

(e) Demonstrate, in the narrative section of the application under “Quality of the Management Plan,” how applicants will ensure that—

(1) The project's intended outcomes, including the evaluation, will be achieved on time and within budget through—

(i) Clearly defined responsibilities of key project personnel, subawards, and contracts, as applicable;

(ii) Procedures to track and ensure completion of the action steps, timelines, and milestones established for key project activities, requirements, and deliverables;

(iii) Internal monitoring processes to ensure that the project is being implemented in accordance with the established application and management plan; and

(iv) Internal financial management controls to increase efficiency and cost-effectiveness, including by reducing waste or achieving better outcomes, and how the applicant will ensure accurate and timely obligations, drawdowns, and reporting of grant funds, as well as monitoring subawards as applicable, in accordance with the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards at 2 CFR part 200 and the terms and conditions of the Federal award;

(2) The allocation of key project personnel, subawards, as applicable, and levels of effort of key personnel are appropriate and adequate to achieve the project's intended outcomes;

(3) The products and services are of high quality, relevance, and usefulness, in both content and delivery and are accessible to individuals with disabilities in accordance with section 504 of the Rehabilitation Act of 1973, as applicable;

(4) The proposed project will benefit from a diversity of perspectives; and

(5) Projects will be awarded and operated in a manner consistent with nondiscrimination requirements contained in the Federal civil rights laws.

(f) Include the following:

(1) In Appendix A, personnel-loading charts and timelines, as applicable, to illustrate the management plan described in the narrative;

(2) In Appendix A, a logic model  4 that depicts, at a minimum, the goals, activities, outputs, and outcomes of the proposed project;

(3) An assurance to maintain a high-quality website, with an easy-to-navigate design that is accessible to individuals with disabilities in accordance with Section 504 of the Rehabilitation Act of 1973, as applicable; and

(4) An assurance that training and technical assistance materials such as outreach, training curricula, presentations, reports, outcomes, and other relevant information will be submitted to RSA's National Clearinghouse of Rehabilitation Training Materials (NCRTM) ( https://ncrtm.ed.gov/ ) at least 90 days before the end of the final budget period.

Underserved populations means Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders, and other persons of color.

When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the Federal Register . The effect of each type of priority follows:

Absolute priority: Under an absolute priority, we consider only applications that meet the priority (34 CFR 75.105(c)(3)).

Competitive preference priority: Under a competitive preference priority, we give competitive preference to an application by (1) awarding additional points, depending on the extent to which the application meets the priority (34 CFR 75.105(c)(2)(i)); or (2) selecting an application that meets the priority over an application of comparable merit that does not meet the priority (34 CFR 75.105(c)(2)(ii)).

Invitational priority: Under an invitational priority, we are particularly interested in applications that meet the priority. However, we do not give an application that meets the priority a preference over other applications (34 CFR 75.105(c)(1)).

This document does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.

Note: This document does not solicit applications. In any year in which we choose to use this priority, we invite applications through a notice in the Federal Register .

Under Executive Order 12866, the Office of Management and Budget (OMB) determines whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by OMB. Section 3(f) of Executive Order 12866, as amended by Executive Order 14094, defines a “significant regulatory action” as an action likely to result in a rule that may—

(1) Have an annual effect on the economy of $200 million or more (adjusted every 3 years by the Administrator of OIRA for changes in gross domestic product); or adversely 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 impacts 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 stated in the Executive order, as specifically authorized in a timely manner by the Administrator of OIRA in each case.

This final regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866 (as amended by Executive Order 14094).

We have also reviewed this final regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

(3) In choosing among alternative regulatory approaches, select 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 the behavior or manner of compliance a regulated entity must adopt; and

(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

We are issuing this final priority and definition only on a reasoned determination that their benefits justify the costs. In choosing among alternative regulatory approaches, we selected the approach that maximizes net benefits. Based on the analysis that follows, the Department believes that this regulatory action is consistent with the principles in Executive Order 13563.

We also have determined that this regulatory action does not unduly interfere with State, local, and Tribal governments in the exercise of their governmental functions.

In accordance with these Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.

The Department believes that the costs associated with the final priority and definition will be minimal, while the potential benefits are significant. The Department believes that this regulatory action does not impose significant costs on eligible entities. Participation in this program is voluntary, and the costs imposed on applicants by this regulatory action will be limited to paperwork burden related to preparing an application. The potential benefits of implementing the program will outweigh the costs incurred by applicants, and the costs of carrying out activities associated with the application will be paid for with program funds. For these reasons, we have determined that the costs of implementation will not be burdensome for eligible applicants, including small entities.

The final priority and definition contain information collection requirements that are approved by OMB under OMB control number 1820-0028; the final priority and definition do not affect the currently approved data collection.

Regulatory Flexibility Act Certification: The Secretary certifies that this final regulatory action will not have a significant economic impact on a substantial number of small entities. The U.S. Small Business Administration Size Standards define “small entities” as for-profit or nonprofit institutions with total annual revenue below $7,000,000 or, if they are institutions controlled by small governmental jurisdictions (that are comprised of cities, counties, towns, townships, villages, school districts, or special districts), with a population of less than 50,000.

The small entities that this regulatory action will affect are minority entities and Indian Tribes that may apply. We believe that the costs imposed on an applicant by the final priority and definition will be limited to paperwork burden related to preparing an application and that the benefits of the final priority and definition will outweigh any costs incurred by the applicant. We also believe that there are very few entities that can provide the type of technical assistance required under the final priority and definition. For these reasons, the final priority and definition will not impose a burden on a significant number of small entities.

Intergovernmental Review: This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.

Accessible Format: On request to the program contact person listed under FOR FURTHER INFORMATION CONTACT , individuals with disabilities can obtain this document in an accessible format. The Department will provide the requestor with an accessible format that may include Rich Text Format (RTF) or text format (txt), a thumb drive, an MP3 file, braille, large print, audiotape, or compact disc, or other accessible format.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register . You may access the official edition of the Federal Register and the Code of Federal Regulations at www.govinfo.gov. At this site you can view this document, as well as all other documents of this Department published in the Federal Register , in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

You may be potentially affected by this action if you are a developer or registrant of a PIP. This action also may affect any person or company who might petition the Agency for a tolerance or an exemption from the requirement of a tolerance for any residue of a PIP. 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:

• Pesticide and Other Agricultural Chemical Manufacturing (NAICS code 325320), e.g., pesticide manufacturers or formulators of pesticide products, importers or any person or company who seeks to register a pesticide or to obtain a tolerance for a pesticide.

• Crop Production (NAICS code 111), e.g., seed companies.

• Colleges, universities, and professional schools (NAICS code 611310), e.g., establishments of higher learning which are engaged in development and marketing of PIPs.

• Research and Development in the Physical, Engineering, and Life Sciences (except Nanobiotechnology) (NAICS code 541714), e.g., biotechnology research and development laboratories or services.

If you have any questions regarding the applicability of this action to a particular entity after reading the regulatory text, consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

This rule establishes exemptions under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. and codified at 40 CFR 174.26 and 174.27 and for the residues of such PIPs under the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a and codified at 40 CFR 174.541 for certain PIPs that are created in plants using biotechnology. In this final rule, the term “exemption” is applied to actions under both of these statutes. (EPA notes that this action only exempts qualifying PIPs from regulation under FIFRA and the need to establish a tolerance for residues of qualifying PIPs under section 408(e) of the FFDCA; other statutory or regulatory requirements may still apply, e.g., State, Tribal, or local requirements). This rule provides criteria and definitions that identify the two groups of PIPs that are exempted through this action, called “PIPs created through genetic engineering from a sexually compatible plant” and “loss-of-function PIPs,” and codifies the process through which the Agency determines their eligibility for exemption. The rule also codifies the recordkeeping requirements for exempted PIPs, and the preamble, along with the accompanying Response to Comments document (Ref. 1), addresses the public comments that the Agency received on the proposed rule (85 FR 64308; October 9, 2020; FRL-10014-10) (Ref. 2) during the public comment period. EPA's responses to those comments are summarized in Unit IV. and in the Response to Comments document (Ref. 1) that is available in docket for this action.

This action is being taken under the authority of FIFRA section 25 (7 U.S.C. 136w) and FFDCA section 408(e) (21 U.S.C. 346a(e)). FIFRA section 25(a)(1) authorizes EPA to issue regulations to carry out the provisions of FIFRA in accordance with certain procedures prescribed in that section. In addition, FIFRA section 25(b) allows EPA to promulgate regulations to exempt from the requirements of FIFRA any pesticide which the Administrator determines is “of a character which is unnecessary to be subject to [FIFRA] in order to carry out the purposes of [FIFRA].” FFDCA section 408(e) authorizes EPA to initiate actions to establish tolerances or exemptions for pesticide chemical residues that meet the safety standard. Section 408 of the FFDCA is focused on human risk. To make a safety finding under FFDCA to support a tolerance or exemption for pesticide residues on food, EPA considers, among other things: the toxicity of the pesticide and its metabolites and degradates, aggregate exposure to the pesticide in foods and from other sources of exposure, and any special risks posed to infants and children. The potential for pesticide exposure through food from food-producing animals that consume feed is part of the human health risk assessment used in EPA's FFDCA determinations. Risk to non-target organisms and risk associated with occupational exposure is evaluated under FIFRA. A more detailed discussion of EPA's statutory authority is available in Units III.A., III.B., and III.C. of the proposed rule (85 FR 64313-64314, October 9, 2020) (Ref. 2).

Recent advances in genetic engineering offer not only precise means by which genes coding for pesticidal substances can be inserted into a plant genome but also allow for modifications of genes that already exist within a plant. Due to the sophistication of these technologies, PIPs can now be created through genetic engineering that are virtually indistinguishable from those created through conventional breeding. These advances also allowed EPA to develop specific exemption criteria to circumscribe PIPs created through genetic engineering that pose no greater risk than the PIPs created through conventional breeding that have been exempt since 2001.

This rule is an effort to implement the policy goals articulated by multiple administrations to improve, clarify, and streamline regulations of biotechnology, beginning with the White House Office of Science and Technology Policy in a policy statement in 1986 on the “Coordinated Framework for the Regulation of Biotechnology” (51 FR 23302; June 26, 1986), the update to the Coordinated Framework in 2017 (Ref. 3), Executive Order 13874 (84 FR 27899, June 11, 2019) on “Modernizing the Regulatory Framework for Agricultural Biotechnology Products,” and more recently, Executive Order 14801 (87 FR 56849, September 12, 2022) on “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.”

EPA has evaluated the potential incremental impacts of the proposed exemptions in the document entitled “Cost Analysis For the Final Rule Exempting Certain Plant-Incorporated Protectants (PIPs) from Registration” (Ref. 4), which is available in the docket and is briefly summarized here.

This rule reduces the regulatory hurdle (primarily cost) of getting certain PIPs to market. Accordingly, this rule is likely to encourage more research and development in this area of biotechnology and better enable firms of all sizes to engage in the development of these types of PIPs. Entities producing products designed for minor crops may not support markets large enough to warrant fixed registration costs. These entities may feel the most regulatory relief as a result of this rule.

Crop varieties modified for greater pest and disease resistance could increase the diversity of options for pest and disease management, which in turn, could provide environmental benefits and lower exposure for workers who apply pesticides. Growers may also benefit because they will have more tools available to combat pest pressures.

The rule is estimated to reduce overall registration costs (fees plus information and data requirement costs) to developers of “PIPs created through genetic engineering from a sexually compatible plant” and “loss-of-function PIPs.” On a per-product basis, the cost savings are estimated to range from $472,000-$886,000 using a 3% discount rate on future maintenance fees. A range of cost savings is provided because “loss-of-function PIPs” have fewer data requirements than “PIPs created through genetic engineering from a sexually compatible plant” and are not required to submit a request for EPA confirmation (thereby avoiding an M009 PRIA fee). Therefore, the savings to developers for “loss-of-function PIPs” is higher.

On an annual basis, the Agency estimates that anywhere from one to ten PIPs may be eligible for exemption. This upper and lower bound estimate is provided because, while the number of PIPs eligible for exemption is unknown, EPA has determined that it is likely to be greater than one. This is an increase from the estimate provided in the cost analysis for the proposed rule, which only included savings from one PIP. Accordingly, EPA estimates the annual savings of this rule to range from $472,000-$8,856,000 using a 3% discount rate on future maintenance fees (the lower bound represents one PIP per year and the upper bound represents ten PIPs per year will be eligible for exemption).

Of the entities likely to develop the types of PIPs this rule exempts, EPA currently estimates that approximately 80% are small entities. These cost savings would be realized as EPA approval of new active ingredients are sought. These exemptions are likely to remove a potential barrier to market entry for small entities because the monetary investment via Pesticide Registration Improvement Act (PRIA) fees and information and data requirement costs are substantially reduced from what would have been required under the registration process (in the absence of this rulemaking).

The costs of the rule includes costs imposed on developers and differences to societal welfare as a result of the rulemaking. The cost imposed on developers of PIPs include the costs to:

• Meet the requirements of the eligibility determination process per 40 CFR 174, subpart E;

• Maintain records related to the requirements of the eligibility determination for five years starting from the effective date of the exemption per 40 CFR 174.73; and

• Report any information regarding adverse effects on human health and the environment alleged to be caused by the PIP be reported to EPA per 40 CFR 174.71.

These costs are outlined in the cost analysis for the final rule. In consideration of the benefits and costs of the rule, the net effect is a cost savings to regulated entities. This is because the requirements to meet the eligibility determination process are less than what is required under registration. In the baseline, or no rule scenario, developers must maintain records related to registration; in the rule scenario, developers must similarly maintain records related to the exemption and exemption eligibility determination process—the net effect therefore of this requirement on developers is zero. In both the baseline, or no rule scenario, and in the rule scenario, developers are subject to the adverse effects reporting requirement—the net effect therefore of this requirement on developers is also zero.

The costs of the rule also include differences to societal welfare as a result of the rulemaking, which in this case would be any increased risk to human health or the environment from the change in regulatory oversight from the rule. There are little to no costs such as these anticipated by the rule because the criteria for qualification were chosen to minimize any such risks. EPA has concluded that adverse effects due to aggregate exposure to residues of pesticidal substances from “PIPs created through genetic engineering from a sexually compatible plant” through the dietary, non-food oral, dermal and inhalation routes are highly unlikely.

In a proposed rule issued in October 2020 (Ref. 2), EPA proposed to:

1. Exempt “plant-incorporated protectants based on sexually compatible plants created through biotechnology” (40 CFR 174.26) from the requirement of a tolerance under FFDCA and from certain registration requirements under FIFRA, except for the following requirements: a proposed requirement of recordkeeping (40 CFR 174.73), a proposed eligibility determination process (40 CFR 174, subpart E), and the existing adverse effects reporting requirement for exempt plant-incorporated protectants (40 CFR 174.71);

2. Clarify the general qualifications for exemption for plant-incorporated protectants at 40 CFR 174.21;

3. Clarify how the proposed exemption relates to the existing exemption for plant-incorporated protectants derived from sexually compatible plants at 40 CFR 174.25; and

4. Allow the existing inert ingredient exemption at 40 CFR 174.705 to include biotechnology.

Unit VI. of the proposed rule explained the proposed exemption for “PIPs based on sexually compatible plants created through biotechnology,” detailed the rationale underlying that proposal, and described associated definitions that were proposed for codification or amendment (85 FR 64308) (Ref. 2), and also described the two primary considerations that EPA believed together would constitute the basis for meeting the FIFRA section 25(b)(2) standard for exemption (the pesticidal substance is found in plants that are sexually compatible with the recipient plant; and limitations on the expression profile). Also described were the details of the proposed eligibility determination process, and a proposed recordkeeping requirement for exempted PIPs listed under 40 CFR 174.21(d).

In addition, EPA proposed edits to 40 CFR 174.21 to clarify the applicability of this framework to other PIP exemptions and EPA proposed to clarify the relationship between the proposal on “PIPs based on sexually compatible plants created through biotechnology” and the exemptions currently at 40 CFR 174.25, “Plant-incorporated protectant from sexually compatible plant,” and 40 CFR 174.508, “Pesticidal substance from sexually compatible plant; exemption from the requirement of a tolerance.” EPA also proposed to allow the existing inert ingredient exemption at 40 CFR 174.705 to include inert ingredients created using biotechnology so long as they still meet the existing criteria.

In this action, EPA is finalizing the following:

1. An exemption for a category of “PIPs created through genetic engineering from a sexually compatible plant;”

2. An exemption for a category of “loss-of-function PIPs;”

3. An exemption eligibility determination process for certain exempted PIPs, including exemption specific information required for submission to support the exemption;

4. Recordkeeping requirements for certain exempted PIPs;

5. Clarifications for the general qualifications for exemption at 40 CFR 174.21;

6. Clarifications on the relationship between the existing exemptions for PIPs from sexually compatible plants and the newly issued exemption for “PIPs created through genetic engineering from a sexually compatible plant;” and

7. Allow the existing inert ingredient exemption at 40 CFR 174.705 to include genetic engineering.

This rule exempts from all FIFRA requirements, except for the adverse effects reporting requirements at 40 CFR 174.71, the recordkeeping requirements at 40 CFR 174.73 (as specified in 40 CFR 174.21(d)), and the eligibility determination process outlined in subpart E, “PIPs created through genetic engineering from a sexually compatible plant.” In the proposed rule, PIPs described under 40 CFR 174.26 were termed “PIPs based on sexually compatible plants created through biotechnology.” In this final rule, EPA has updated the name of the PIPs described under 40 CFR 174.26 to be “PIPs created through genetic engineering from a sexually compatible plant” based on public comment, as discussed in Unit IV.A.3.

The language describing the exemption appears in 40 CFR 174.26. Pertinent definitions associated with the exemption are found in 40 CFR 174.3 and include:

“ Gene ” and other grammatical variants such as “genic,” means a unit of heritable genetic material that is comprised of the genetic material necessary for the production of a substance.

The definition for “gene” was revised from the proposal to remove the word “functional” before the phrase “unit of heritable genetic material that is comprised of the genetic material necessary for the production of a substance.” EPA made this change because loss-of-function traits are created by targeting a gene underlying an unwanted trait by reducing or removing the gene's function. While the gene may no longer be functional, structurally it is still a gene. Although this is commonly understood in the scientific community, removing the word “functional” from the definition may reduce confusion over the relationship between the definition of “gene” and “loss-of-function PIPs.” Therefore, for the reasons outlined, EPA removed the word “functional” from the definition of “gene.” As discussed in Unit V.A. of the proposal, the two genic regions relevant to the exemptions under 40 CFR 174.26 are the coding and regulatory regions. These regions are delineated through use of the phrase “genetic material necessary for the production,” which as defined under 40 CFR 174.3 means both “genetic material that encodes a substance or leads to the production of a substance; and regulatory regions. It does not include noncoding nonexpressed nucleotide sequences.” “Noncoding, nonexpressed nucleotide sequences” is also defined under 40 CFR 174.3 and includes examples such as linkers, adapters, homopolymers, and sequences of restriction enzyme recognition sites (further discussed in the context of these exemptions in Unit IV.B.1.).

“ Genetic engineering ” means the modification of the genome of an organism using recombinant, synthesized, or amplified nucleic acids or other techniques excluded from the definition of conventional breeding. “Genome” is a defined term in 40 CFR 174.3 which means “the sum of the heritable genetic material in the plant, including genetic material in the nucleus and organelles.” EPA believes the use of the defined word “genome” in the “genetic engineering” definition would capture genetic engineering edits resulting in modifications to the proteome or transcriptome that are stably heritable.

As discussed in Unit IV.A.2., EPA received a comment suggesting a definition for “biotechnology.” However, for consistency across the Coordinated Framework, the Agency chose to instead define “genetic engineering.” EPA used the two phrases synonymously in its proposed rule and therefore does not consider the change from “biotechnology” to “genetic engineering” to be substantive. For additional discussion on maintaining consistency across the Coordinated Framework for exemptions of products derived from genetic engineering, see Unit III.H.: “Alignment of the proposed rule with USDA's amendment to 7 CFR 340” of the Response to Comments document in the docket associated with this rulemaking.

“ Native allele ” means a variant of a native gene that is identified in the genetic diversity of plants sexually compatible with the recipient plant.

“ Native gene ” means a gene that is identified in the recipient plant or source plants that are sexually compatible with the recipient plant. It does not include genes introduced through genetic engineering from a source organism that is not sexually compatible with the source plant.

The definition for “native gene” was revised from the proposal based on public comment (Unit IV.A.1.). In the proposal, rather than specifically excluding genes introduced through recombinant DNA or similar techniques from a non-sexually compatible source organism, EPA used the term “never derived.” EPA received comment suggesting that a greater focus on excluding transgenes ( i.e., genes introduced from non-sexually compatible organisms) may aid in clarity and in turn reduce uncertainty around genes originating through natural horizontal gene transfer. EPA agreed with the suggestion and revised the definition to state EPA's intent more explicitly as outlined in the proposed rule ( i.e., to exclude substances that conventional plant breeders do not have experience with, such as a bacterial endotoxin not historically found in a food plant). Screening practices and analyses performed as part of the standard conventional breeding process serve to eliminate plants that raise safety, quality or performance concerns. By limiting exempt substances to those in which conventional plant breeders have experience, EPA can have confidence that these conventional plant breeding practices would still be protective for substances of exempt PIPs.

In addition, EPA revised the definition in 40 CFR 174.3 for “ Sexually compatible. ” In the proposed definition EPA stated that “a viable zygote can be formed.” This phrase was minorly revised to state “plants must be capable of forming a viable zygote” for clarity.

PIPs that are created through genetic engineering but that could have otherwise been created through conventional breeding are exempt (40 CFR 174.26). The exemption criteria and associated definitions circumscribe PIPs that are created through genetic engineering using knowledge of nucleotide sequences in sexually compatible source plants to re-create a native allele or other functional nucleotide sequence identical to that which is found in a source plant. This would enable the use of genetic engineering of clonally-propogated cultivars of crops such as potato, grape, tree fruits, etc., to recreate pesticidal alleles found in sexually compatible cultivars or crop wild relatives. The exemption specifies criteria regarding the types of modifications that are allowed to be made to ensure that the exempt PIPs are characteristic in identity and in expression profile to those found in conventionally bred plants, and are therefore substances with which conventional plant breeders and conventional plant breeding screening methods have experience.

The scope of “PIPs created through genetic engineering from a sexually compatible plant” is delineated in 40 CFR 174.26(a). The regulatory text identifies two overarching categories that specify what will qualify as an exempt PIP pesticidal substance: (1) The insertion of new genetic material and (2) The modification of existing genetic material.

The provision at 40 CFR 174.26(a)(1) allows for insertions of new genetic material into the recipient plant so long as the genetic material is a native gene that is found in the sexually compatible plant population of that plant. This category requires that the entire pesticidal substance ( e.g., amino acid sequence for proteinaceous PIPs) that is created from the native gene be identical to that produced in the source plant. 40 CFR 174.26(a)(1) was revised from the proposed text to include a criterion related to inserted regulatory regions. 40 CFR 174.26(a)(1) now requires that any regulatory regions inserted as part of the native gene be identical to the regulatory regions of the native gene identified in the source plant. This change was made in response to comments EPA received stating that the proposed criterion related to expression profile (proposed 40 CFR 174.26(b)) was unclear (Units IV.C.2. and IV.E.4.b.). In response to these comments, EPA instead now provides specific criteria at codified 174.26(a)(1) related to the types of modifications that may impact expression. EPA is aware that intronic regions of genes may exhibit regulatory functions, but EPA does not expect that all introns necessarily need to be inserted as part of a native gene. Therefore, when describing the criterion related to identical sequences in the regulatory regions, EPA used the phrase “regulatory regions inserted as part of the native gene,” to specify that the criterion only applies to those regulatory regions that are ultimately inserted as part of the native gene ( i.e., it is not required that all regulatory regions be inserted, but those that are inserted must meet the criterion).

The final text in 40 CFR 174.26(a)(1) was revised from what was in the proposed text to remove the clause “into a non-genic location” in the phrase “A native gene is engineered into a non-genic location of the recipient plant genome [. . .].” In the proposal, EPA stated that this phrase was intended to preclude the insertion of the native gene into an existing gene to prevent the production of a novel substance ( e.g., a partial or modified substance) by the existing gene. However, upon further evaluation of this clause, prompted by public comment (Response to Comments document Unit III.A.3.), EPA determined that this restriction is not necessary as any novel substance that would be produced as a result of a fusion with the inserted PIP gene ( i.e., through the creation of a novel open reading frame), would not meet the exemption under 40 CFR 174.26.

The provision at 40 CFR 174.26(a)(2) describes permissible modifications to the existing genetic material in the recipient plant. 40 CFR 174.26(a)(2) allows for modifications of the existing native gene to match corresponding polymorphic sequence(s) in a native allele of that gene using a single source plant as a template. Polymorphisms are variants of a gene sequence that are shared between native alleles. These genetic variations may be composed of single nucleotides ( i.e., Single nucleotide polymorphisms (SNPs)) or larger DNA segments and they are found at the same locus within the genetic sequence of two or more native alleles. In some cases, enhanced pesticidal properties of a gene product can be attributed to one or more of these genetic variations within a native gene (Refs. 5, 6). The final rule (see 40 CFR 174.26(a)(2)) allows developers to utilize their knowledge of specific polymorphisms in regulatory and coding regions of native alleles to make changes to the native gene in their recipient plant. The phrase “using a single source plant as a template” in the provision limits the number of source plants for the polymorphic sequences to one. For example, it is not permissible to modify the polymorphic sequence of a native gene (in the recipient plant) to match a polymorphic sequence found in the native allele of a source plant and also modify a second polymorphic sequence in the native gene to match a sequence found in the native allele of a different source plant. This requirement is because EPA believes that increasing the amount of plants used as source plants for a single PIP may also lead to an increase in the likelihood that the substance is altered to something that plant breeders may not have experience. The second part of the phrase “as a template” indicates that the polymorphism that is engineered into the recipient plant must be identical in sequence to that which is found in the native allele of the source plant.

The final rule (see 40 CFR 174.26(a)(2)) differs from what was proposed at 40 CFR 174.26(a)(2)(ii) in that EPA previously proposed to require that modifications resulting in a native allele produce a pesticidal substance identical to that produced in the source plant. The exemption category at 40 CFR 174.26(a)(2) is promulgated in response to comments received indicating that the proposed exemption categories were too narrow in that they do not capture the full extent of genetic variation that can occur in plants (Unit IV.C.1.). While the final text in 40 CFR 174.26(a)(2) does not require the entire substance to be identical to a substance found in the sexually compatible population of the recipient plant, it does require the individual polymorphism(s) to have been identified. By requiring the polymorphic sequences to be identical, this new exemption category allows the Agency to capture more of the possible genetic variation that can occur in plants, while staying within the bounds of what could have been achieved through conventional breeding and what was proposed.

EPA acknowledges that the genetic variation that is observed in plants has the potential to be greater than what is captured at 40 CFR 174.26(a). Therefore, the Agency intends to revisit the question of capturing a broader range of genetic variation under 40 CFR 174.26 in the future; a new rulemaking process that would be initiated by the Agency if, for example, new scientific information becomes available or if prompted by an interested party through an Agency inquiry, e.g., based on a specific PIP product. Importantly, any new categories of exempt PIPs that would be added to 40 CFR 174.26 through this process in the future: (1) Would be required to fall within the previously defined scope of exempt PIPs, i.e., those that can be created through conventional breeding; (2) Would be subject to recordkeeping requirements and documentation for exemption (Unit III.D.); and (3) Would at least initially be subject to the EPA confirmation process (Unit III.C.3.). By adhering to these requirements, EPA can ensure that any future categories of PIPs created through genetic engineering from sexually compatible plants will remain within the scientific scope that was presented in the proposal, and that underlies the current exemptions at 40 CFR 174.26, and that these categories would remain subject to the procedural guard rails set in place by the eligibility determination process.

The proposed regulatory text included additional categories that are not being finalized under 40 CFR 174.26. To increase clarity, the category encompassing “loss-of-function PIPs” that was proposed at 40 CFR 174.26(a)(2)(iv) has been removed and a new, stand alone exemption for “loss-of-function PIPs” at 40 CFR 174.27 was created in its place (Unit III.B.). Proposed 40 CFR 174.26(a)(2)(i) allowed for regulatory region modifications so long as the pesticidal substance remained unchanged, but relied on proposed 174.26(b) to specify the bounds of the expression profile. However, EPA received public comment stating that the criterion related to expression profile at proposed 40 CFR 174.26(b) was unclear (Units IV.C.2. and IV.E.4.b.). In response to these comments, 40 CFR 174.26(a)(2) now includes a criterion related to inserted regulatory region modifications ( i.e., must match corresponding polymorphic sequences in a native allele), therefore making proposed 40 CFR 174.26(a)(2)(i) redundant. Because proposed 40 CFR 174.26(a)(2)(i) was removed, proposed 40 CFR 174.26(a)(2)(iii) was also removed as it was dependent on proposed 40 CFR 174.26(a)(2)(i). Proposed 40 CFR 174.26(a)(2)(ii) is effectively a subset of what is possible under codified 40 CFR 174.26(a)(2), and is therefore not finalized. Finally, proposed 40 CFR 174.26(b) previously specified expression profile bounds, but due to public comment, EPA now includes specific criteria related to allowable modifications that could impact expression in the subsections of 40 CFR 174.26(a), thereby making proposed 40 CFR 174.26(b) unnecessary.

EPA does not believe that the removal of the proposed categories from the final regulatory text at 40 CFR 174.26 reduces the scope of PIPs exempted through this rulemaking since proposed 40 CFR 174.26(a)(2)(iv) is now being finalized as 40 CFR 174.27, proposed 40 CFR 174.26(a)(2)(ii) represents a subset of what can be accomplished under codified 40 CFR 174.26(a)(2), and since proposed 40 CFR 174.26(a)(2)(i) and proposed 40 CFR 174.26(a)(2)(iii) were deemed redundant.

The final text of 40 CFR 174.26(b) states that the requirements in 40 CFR 174.21(d) ( i.e., the recordkeeping requirements and the eligibility determination procedures) must be met in order for the exemption to apply. This is minorly revised from the proposed regulatory text which stated that the “exemption does not apply until the requirements in subpart E of this part have been met;” however, the recordkeeping requirements are located in subpart D, and therefore citing to 40 CFR 174.21(d) is a more streamlined citation.

In addition to exempting the active ingredient of PIPs created through genetic engineering from sexually compatible plants from the requirements of FIFRA, EPA is also finalizing the exemption for residues of these substances from the requirement of a tolerance under the FFDCA at 40 CFR 174.541. The exemption criteria are identical to those at 40 CFR 174.26 except that in order to be exempted from the requirements of a tolerance, residues of the pesticidal substance must also not be present at levels that are injurious or deleterious to human health (40 CFR 174.541(b)). The “injurious or deleterious” language is included in this rule to align with the same criteria found in 40 CFR 174.508 for residues of PIPs in sexually compatible plants. ( https://www.govinfo.gov/content/pkg/FR-2001-07-19/pdf/01-17983.pdf ). This language was adopted in the 2001 rule in response to comments about the potential for naturally occurring compounds to be present in foods at hazardous levels and to be more consistent with FDA policy and the standard applied to evaluate adulterated food: “food shall be deemed to be adulterated . . . if it bears or contains any poisonous or deleterious substance which may render it injurious to health. . . .” 21 U.S.C. 342(a)(1). The purpose of this language was to allow expeditious removal of the offending food from the market if injurious or deleterious levels of a substance were present in food. All of the criteria in 174.541 must be met: the conditions in paragraph (a) limit the identity of the substance, the condition in paragraph (b) set limits on the level of expression in the plant, and the conditions in paragraph (c) ensure the application of the exemption is properly documented. Regarding the condition in paragraph (b), one example of how this might work is if a source plant were to produce a pesticidal substance at levels that are injurious or deleterious to human health, that PIP would not qualify for exemption if the level of expression in the recipient plant matched the injurious or deleterious levels seen in the source plant. It is also important to note that EPA considers multiple native gene insertions of the same gene to be one PIP (further discussed in Unit IV.B.2.), so the criterion related to safe expression levels in food plants (40 CFR 174.541(b)) would apply to the overall expression level from all inserted gene copies. Developers modifying or inserting genes that produce substances with sequence homology to known mammalian toxins, toxicants, or allergens should ensure that the levels of pesticidal substances are within the ranges of levels generally seen in plant varieties currently on the market and known to produce food safe for consumption ( i.e., ensure that their levels are not injurious or deleterious to human health). Such substances expressed above these levels would likely trigger additional review during the EPA confirmation and may not fit the exemption criteria.

Additionally, 40 CFR 174.541(c) has been edited to more specifically cite to 40 CFR 174.90, rather than the entire subpart E. This citation is different from that found at 40 CFR 174.26(b) due to a difference in statutes. Specifically, 40 CFR 174.26(b) cites to 40 CFR 174.21(d), which describes the general qualifications for exemption under FIFRA, whereas 40 CFR 174.541 is an exemption from the requirement of a tolerance under FFDCA and therefore would not cite to exemption qualifications under FIFRA. Because the regulatory text at 40 CFR 174.26 for the active ingredient of “PIPs created through genetic engineering from a sexually compatible plant” and the corresponding tolerance exemption for residues of these active ingredients at 40 CFR 174.541 are identical (except for the two clauses discussed in this paragraph) all other changes to the regulatory text that were discussed for 40 CFR 174.26 in this Unit were also applied to 40 CFR 174.541.

This rule exempts “loss-of-function PIPs” from all FIFRA requirements, except for the adverse effects reporting requirements at 40 CFR 174.71, the recordkeeping requirements at 174.73 (as specified in 40 CFR 174.21(d)), and the eligibility determination process outlined in subpart E. The exempt PIPs represent a subcategory of PIPs described in the proposed rule (Ref. 2). In this final rule, EPA is creating a separate exemption for “loss-of-function PIPs,” which allows the Agency to create criteria specific to these types of PIPs and an accompanying definition for increased clarity. EPA made this change in response to comments that indicated the need for greater clarity and the broadening of the exemption text related to “loss-of-function PIPs” regarding the identicality of the substance (Unit IV.D.2.). As discussed in Unit IV.D.1., the modified genetic material of a “loss-of-function PIP” constitutes both the pesticidal substance and the active ingredient. The language describing the exemption appears in 40 CFR 174.27.

Because EPA is creating a separate exemption for “loss-of-function PIPs,” EPA is also codifying a definition associated with the exemption in 40 CFR 174.3:

“ Loss-of-function plant-incorporated protectant ” means a plant-incorporated protectant in which the genetic material of a native gene is modified to result in a pesticidal effect through the reduction or elimination of the activity of that gene. For purposes of loss-of-function plant-incorporated protectants, the active ingredient and pesticidal substance are one and the same and are defined as the genetic material that has been modified to create the pesticidal trait ( i.e., modification of the sequence of nucleic acids). Loss-of-function plant-incorporated protectants do not include instances where the reduction or elimination of the activity of the modified native gene results in the intentional increase of activity of another pesticidal gene.

The first sentence of this definition specifies that for a PIP to be considered a “loss-of-function PIP,” a pesticidal effect must be created through the genetic modification of a native gene, which then leads to the reduction or elimination of the activity of that native gene. The second sentence defines the regulated substance (see Unit IV.D.1. for additional discussion). The third sentence explicitly excludes the scenario in which a modification of a native gene not only leads to the reduction in the expression of that native gene, but additionally leads to an increase of activity of another, “secondary” gene, with that “secondary” gene then conferring the pesticidal activity ( e.g., the altered gene encodes for a repressor whose absence does not itself lead to a pesticidal effect but rather the increased expression of a second gene that encodes a pesticidal substance). This definition is consistent with the description of “loss-of-function PIPs” in Unit VII.E. of the proposed rule (Ref. 2).

Both the definition at 40 CFR 174.3 and the exemption text at 40 CFR 174.27 focus on the loss-of-function trait that results from the modification ( i.e., the reduction or elimination of the activity of the modified gene), and do not include requirements related to source plants or limit the location within the gene to which modifications are allowed to be made ( i.e., regulatory region or coding region). Specifically, 40 CFR 174.27 specifies two requirements, the first of which at 40 CFR 174.27(a) is almost identical in language to the loss-of-function definition and specifies that the genetic modification must result in a “loss-of-function PIP.” The type of genetic modification to a native gene that results in the loss of activity of that gene is not relevant so long as a “loss-of-function PIP” is the result of that modification. As with the exemptions at 40 CFR 174.26, the second requirement at 40 CFR 174.27(b) specifies that the exemption for “loss-of-function PIPs” only goes into effect after the requirements for the eligibility determination in 40 CFR 174.21(d) have been met.

In the proposed rule, “loss-of-function PIPs” were a subcategory under 40 CFR 174.26 (specifically proposed 40 CFR 174.26(a)(2)(iv)), and they were held to the same “identical substance” criterion as other PIPs described in proposed 40 CFR 174.26. While the EPA does not find that it can make an a priori safety determination under FIFRA and FFDCA for non-identical pesticidal substances now exempted under 40 CFR 174.26 (Unit IV.C.1.), it finds that no such restriction is warranted for “loss-of-function PIPs” under 40 CFR 174.27 (Unit IV.D.2.). This conclusion is based on characteristics of “loss-of-function PIPs,” the common occurrence of pesticidal traits resulting from the loss-of-function of endogenous genes in conventional breeding, and the biological processes that all proteins undergo within plants (Unit IV.D.2.).

The absence of function is a hallmark of “loss-of-function PIPs,” e.g., loss of the activity of a native gene that would otherwise facilitate the susceptibility of that plant to a pathogen. Importantly, the criteria and definition state that for a “loss-of-function PIP,” the native gene modification results in a pesticidal effect from the reduction or elimination of the activity of that gene. This indicates a direct cause-and-effect relationship between the reduction in the expression of a specific native gene and a pesticidal effect. This direct cause-and-effect relationship also means that not all modifications that lead to a loss-of-function of a gene and that result in a pesticidal effect are considered “loss-of-function PIPs.” For example, this scenario may occur if a modification of a native gene not only leads to the reduction in the expression of that native gene, but also to an increase of the activity of another, “secondary” gene, with that “secondary” gene then conferring the pesticidal activity ( e.g., the altered gene encodes for a repressor protein whose absence does not itself lead to a pesticidal trait but rather the increased expression of a second gene that encodes a pesticidal substance). Because in this instance there is no direct cause-and-effect relationship between the reduction of the expression of the modified native gene and the pesticidal effect, that gene modification and resulting “secondary” activity would not be considered a “loss-of-function PIP” under 40 CFR 174.27. Further, in the scenario described, that gene modification and resulting “secondary” activity would only be exempt under the new regulations if it meets the criteria outlined in 40 CFR 174.26 and from FFDCA if the residues meet the requirements under 40 CFR 174.541. For “loss-of-function PIPs,” EPA clearly indicates the requirement for this direct cause-and-effect relationship of native gene modification and the pesticidal effect in the second sentence of the “loss-of-function PIP” definition.

The Agency is finalizing subpart E, which includes provisions describing the eligibility determination process and documentation required for an exemption of certain PIPs. Specifically, in order for a PIP listed under 40 CFR 174.21(d) to be eligible for exemption, an exemption eligibility determination must be completed prior to engaging in FIFRA-regulated activities. EPA agrees with commenters arguing that requiring an eligibility determination will provide additional clarity to developers of PIP products under certain circumstances and increase transparency and public trust in products containing these PIPs (Unit IV.E.1.). The primary difference between the proposal and the final rule is the restriction of the self-determination option to only certain PIPs exempted by this rulemaking. In the proposal, all exempted PIPs had the option of self-determination. However, in the final rule, only developers of “loss-of-function PIPs” (40 CFR 174.27) currently have the option to self-determine whether the exemption criteria are met. To that end, modifications were made to proposed 40 CFR 174.90, 40 CFR 174.91, and 40 CFR 174.93 (Units III.C.1., C.2., and C.3.). In addition, the titles of these three subsections were minorly revised from the proposal for clarity.

Given the straightforward criteria describing “loss-of-function PIPs” ( i.e., a focus on function rather than source plant or underlying sequence), EPA believes it is appropriate for “loss-of-function PIPs” to be eligible for the self-determination option as it is unlikely for a developer to accidentally misdetermine exemption eligibility of these PIPs. Additionally, the mode of action of “loss-of-function PIPs” ( i.e., reduction or elimination of an endogenous gene) is fundamentally different from “PIPs created through genetic engineering from a sexually compatible plant” ( e.g., intentional production of a pesticidal protein), and as such, further lends itself to the availability of a self-determination option. Although “PIPs created through genetic engineering from a sexually compatible plant” are not currently eligible for the self-determination option, EPA intends to reconsider this in future rulemakings.

A separate determination of eligibility of exemption for purposes of the FFDCA exemption for a PIP proposed for use in food or feed is required only if that determination has not already been submitted under FIFRA. This is because the exemption eligibility determination process described in 40 CFR 174.21 already requires the applicant to certify that the PIP meets the general qualifications for exemption, which includes exemption under the FFDCA for PIPs used in food or feed. A scenario in which a developer will need an exemption eligibility determination specifically for the purposes of FFDCA, but not FIFRA, would be when residues of a PIP are in or on food imported into the United States, but the PIP is not intended to be sold or distributed for pesticidal use ( e.g., PIP-containing seed or plant sold for planting) in the United States (and thus is not subject to FIFRA regulation). Additional discussion on the types of activities that warrant an eligibility determination can be found in Unit IV.E.5.

Regarding the process of an exemption eligibility determination under 40 CFR 174.90, this provision states at 40 CFR 174.90(a) that, depending on the applicable exemption, developers have two, non-mutually exclusive options to notify EPA that their PIP meets the exemption criteria: (1) Seek EPA confirmation that a PIP meets the exemption criteria, and (2) Submit a self-determination letter that a PIP meets the exemption criteria. For PIPs subject to the eligibility determination process, an EPA confirmation is mandatory unless the PIP is listed at 40 CFR 174.90(a)(2) as eligible for the self-determination option. For PIPs eligible for the self-determination option, an EPA confirmation can be sought instead of, in conjunction with, or subsequent to the submission of the self-determination letter.

As stated in Unit III.C., only “loss-of-function PIPs” under 40 CFR 174.27 are currently eligible for the self-determination option and no “PIPs created through genetic engineering from a sexually compatible plant” under 40 CFR 174.26 are currently listed under 40 CFR 174.90(a)(2). Therefore all “PIPs created through genetic engineering from a sexually compatible plant” are required to undergo an EPA confirmation process. However, EPA intends to reconsider this in future rulemakings, and as such, EPA has codified text at 40 CFR 174.90(a)(2)(ii) to accommodate this possibility.

The provision explains at 40 CFR 174.90(b) that submissions for a request for EPA confirmation or a letter of self-determination must be made electronically, which means that they may not be made by mailing the information in physical form to the Agency ( e.g., sending hard copies or data storage devices such as DVD). Specifically, electronic submissions are required to be made through EPA's electronic submission portal which receives legally acceptable data in a secure manner (see Unit IV.E.6. for additional discussion). That system is used, amongst other things, for submission of pesticide registration applications, and will now additionally accommodate the eligibility determination processes associated with the PIPs identified in this rule. The electronic submission process will accommodate submissions when the final rule is effective, specifically, 60 days after the date of publication in the Federal Register . This electronic submission process differs from the proposal, which included instructions on how to submit a self-determination or confirmation request via physical mail. Guidance for electronic submission can be found in Pesticide Registration Notice 2011-3 (Ref. 7) or any subsequent revision or replacement. The provision at 40 CFR 174.90(c) also explains the procedures that must be followed to claim information submitted as confidential.

For PIPs that are eligible for both the self-determination and EPA confirmation options, the provision at 40 CFR 174.90(d) further explains the relationship between the EPA confirmation processes and a letter of self-determination. Specifically, if a developer chooses to request EPA confirmation in accordance with 40 CFR 174.93 in conjunction with or subsequent to submitting a self-determination letter in accordance with 40 CFR 174.91, the exemption is effective from the time the company receives confirmation of submission of the self-determination letter. The exemption remains effective if EPA affirms the developer's determination that the PIP meets the exemption criteria and the self-determination is superseded by EPA's written confirmation in response to the confirmation request. Alternatively, in instances in which no prior self-determination has been provided to the Agency in accordance with 40 CFR 174.91, and the developer submits a request for confirmation to the Agency, the exemption applies only once EPA provides written notice to the developer confirming that the PIP meets the criteria for exemption.

The provision also includes text at 40 CFR 174.90(e) stating that EPA reserves the right to assess or revisit at any time after EPA issues a confirmation of eligibility or the letter of self-determination is submitted, whether a PIP meets, or has met, the criteria for exemption. If EPA finds or has reason to believe that, at any time before or during this review of eligibility for exemption, the product is non-compliant with FIFRA or presents an adverse risk to human health, the environment, or program integrity, the Agency can take immediate steps—including enforcement—to address that non-compliance or to protect against those adverse risks. This is revised from the proposed text to make explicitly clear that although EPA will generally notify the submitter in writing of EPA's intention to initiate a review of eligibility for exemption, EPA may take such action without first informing the submitter of an eligibility review if the situation warrants.

As exempt PIPs are still subject to 40 CFR 174.71, upon learning of any adverse effects ( i.e., that a person or nontarget organism allegedly suffered an adverse effect due to exposure to a PIP), EPA has the authority to evaluate whether the PIP still meets the criteria for exemption. As described in the preamble of the July 19, 2001, Federal Register notice implementing 40 CFR 174.71 (66 FR 37772; July 19, 2001; FRL-6057-7) (Ref. 8), reports involving food or feed ( i.e., those subject to enforcement under FFDCA) would be made to EPA, but EPA will share such reports with FDA. EPA and FDA will individually determine whether any action, including the possibility of enforcement, is necessary to protect the public health or the environment, and if so, what constitutes appropriate action based on their respective statutes (EPA-FIFRA; FDA-FFDCA). Additional discussion regarding EPA enforcement can be found in Unit III.D.7. of the Response to Comments document found in the docket associated with this rulemaking.

The provision outlines instances at 40 CFR 174.90(f) in which an exemption determination for a PIP can be extended to other PIPs. A determination that a PIP meets the exemption criteria would be required for each modified gene and plant species combination ( e.g., PIP “A” in corn and PIP “A” in tomato would each require their own determination). However, EPA is aware that a plant species can comprise multiple varieties and does not intend for the PIP in each variety to require its own submission. In order to extend the exemption for a PIP, the developer would need to comply with the provisions outlined in 40 CFR 174.21(d) for the first modification in that plant species and that exemption can then be extended in one of two ways. If the exempted PIP is moved through conventional breeding, the exemption is extended to the subsequent PIP. To extend the exemption of the PIP to subsequent genetic engineering events, the PIP must meet exemption-specific criteria outlined by EPA. The paragraph in this text was edited from the proposed rule to explicitly state that movement of exempt PIPs through conventional breeding also results in the extension of exemption status of that PIP and to clarify that the subparagraphs 40 CFR 174.90(f)(1) and 40 CFR 174.90(f)(2) are specific to genetic engineering.

For a “PIP created through genetic engineering from a sexually compatible plant,” the exemption extends to subsequent engineering of that PIP by the submitter into other varieties of that same plant species as long as the subsequent PIP produces the identical substance as in the exempt PIP and no new modifications were made to the regulatory regions. For example, if a developer first modifies an existing gene in a tomato variety to create a native allele, this would require a determination; however, if the developer subsequently creates the same native allele in another tomato variety, the developer would not be required to submit a second determination request for the additional variety. For a “loss-of-function PIP,” an exemption extends to subsequent engineering of that PIP by the submitter into other varieties of that same plant species as long as the submitter is targeting the same native gene to create the “loss-of-function PIP.” This text is modified from the proposal based on a comment arguing that the criteria should focus on the trait phenotype and function (Unit IV.E.2.). As described in Unit IV.D.2., “loss-of-function PIPs” now have their own exemption category with a focus on function rather than substance identity, and as such, the extension of the exemption for “loss-of-function PIPs” is now described in 40 CFR 174.90(f)(2) with a similar focus.

Finally, EPA has added a new paragraph (g) to 40 CFR 174.90, which explains that a duplicative eligibility submission is not required for purposes of 40 CFR 174.541(c), if it is already being submitted for purposes of 40 CFR 174.21(d). This provision was not in the proposal, but was added for clarification based on public comment (Unit IV.E.5.). Related to these comments, EPA is confirming that the Agency is requiring a separate eligibility determination to be made through EPA's electronic submission portal for residues of those PIPs under 40 CFR 174.541 that are imported into the United States and that are used for food or feed if the developer has not already obtained an exemption under 40 CFR 174.541. This submission includes an acknowledgement that the developer is only submitting an exemption eligibility determination for the purposes of FFDCA but not FIFRA, and therefore it is not permissible for the PIP to be sold or distributed for pesticidal use ( e.g., PIP-containing seed or plant sold for planting) in the United States. As discussed in the preamble of the proposed rule, a separate submission of the eligibility determination of the FFDCA exemption for a PIP proposed for use in food or feed is required only if it has not already been submitted under FIFRA.

This rule finalizes a new provision in subpart E, 40 CFR 174.91, entitled “Submitting a letter of self-determination” The provision describes the requirements and process of notifying EPA that the developer has determined (or “self-determined”) that a PIP qualifies for exemption.

The provision at 40 CFR 174.91 explains that a developer must submit the letter of self-determination prior to engaging in activities that would be subject to FIFRA for the proposed PIP ( e.g., distribution and sale of the PIP at issue). As specified in 40 CFR 174.90(b), self-determination letters must be submitted electronically. If a developer does not have an EPA company number, they will be required to obtain one in order to be able to submit a self-determination letter. Self-determination letters will not be submitted under FIFRA section 33 and will not be subject to application fees under the Pesticide Registration Improvement Extension Act of 2022 (PRIA 5). The exemption does not apply until EPA confirms receipt of the self-determination, but since the submission of the self-determination letter will be made electronically, the receipt confirmation by the Agency occurs automatically upon submission and is considered equivalent to written confirmation of receipt.

The provision at 40 CFR 174.91(b) includes information on the required contents of the self-determination letter. This includes a statement certifying the developer's determination of exemption eligibility, the identity of the recipient plant, a unique gene identifier for the native gene, the trait type ( e.g., insect resistance), and information on the applicable exemption. The gene identifier is for the native gene (not necessarily the exact sequence of the PIP) and must be from databases curated by the National Center for Biotechnology Information (NCBI), which is part of the National Library of Medicine of the National Institutes of Health (NLM) at the National Institutes of Health (NIH). These databases are available free of charge to scientists globally and will ensure availability of the gene information to EPA and a means to standardize that information. Based on public comment (Unit IV.E.3.), this provision was clarified to explicitly request the identity of the recipient plant, an identifier for the native gene, and the trait type, rather than the name of the PIP, which may or may not have included such information. Additionally, rather than listing PIP categories eligible for self-determination under 40 CFR 174.91(b)(2) as had been proposed, the provision now cites to the list under 40 CFR 174.90(a)(2). Lastly, EPA streamlined the regulatory text by merging 40 CFR 174.91(b)(4) with 40 CFR 174.91(b)(3) and removing the text of the certification statement from the provisions. The statement is captured in the electronic submission portal and thus listing it in the regulatory text was deemed redundant.

EPA notes that the developer is responsible at all times for ensuring the self-determination is accurate and if at any time EPA determines that a self-determination was fraudulently or incorrectly made, or is no longer accurate due to the availability of new information that was not available at the time the self-determination was made, EPA will notify FDA of this new information, and the Agencies can take action to protect the environment and public health, respectively. This includes the possibility of enforcement under FIFRA or FFDCA.

This rule establishes a new provision in subpart E entitled “Requesting EPA confirmation” (40 CFR 174.93), which describes the process through which a developer may seek confirmation from EPA as to whether a PIP meets the criteria for exemption codified in 40 CFR 174.21. A developer must submit information as outlined in 40 CFR 174.91 along with specific supporting documentation. For example, the information required to support the request for a “PIP created through genetic engineering from a sexually compatible plant” is described in 40 CFR 174.95 and discussed in Unit III.C.4.a.

In addition, the provision at 40 CFR 174.93 explains that upon receipt of the request, EPA will review the submission and determine whether the PIP meets all necessary criteria to be exempt under 40 CFR 174.21. The Agency will notify the submitter in writing of its determination. The exemption goes into effect only once the developer receives EPA's confirmation in writing, unless a self-determination letter was previously submitted. As discussed in Unit III.C.1., EPA reserves the right to reassess whether a PIP meets the criteria for exemption should the Agency learn of relevant information subsequent to confirming its eligibility to be exempt under 40 CFR 174.21.

Requests for EPA confirmation are to be submitted using the submission category (M009) and associated fee structure for a Non-FIFRA Regulated Determination under FIFRA section 33 (PRIA). The logistics of the submission for a request and EPA review times may change in the future if PRIA changes or a different structure for submissions is adopted.

The rule finalizes the documentation needed for an exemption for “PIPs created through genetic engineering from a sexually compatible plant.” There are four main information elements associated with the required documentation, which capture the: (1) Biology of the plant; (2) Description of how the trait was engineered into the plant; (3) Molecular characterization of the PIP; and (4) Information on the history of safe use for those PIPs that are either known mammalian toxins or toxicants or that are from a source plant that is a wild relative of the recipient plant. Collectively, this information allows EPA to ensure that a PIP meets the exemption criteria at 40 CFR 174.26 and 40 CFR 174.541.

The first element (40 CFR 174.95(a)) requires information on the biology of the plant and has two components: (1) The identity of the recipient plant, including genus and species; and, if the PIP was derived from another plant species, the identity of the source plant, including genus and species; and (2) Information to support that the recipient plant and the source plant are sexually compatible. The regulatory text regarding sexual compatibility was minorly revised from proposed “if the plant-incorporated protectant was derived from another plant species” to “if the plant-incorporated protectant was derived from a plant species other than the recipient plant species” to more directly articulate that this information is only needed if the source and recipient plant are taxonomically classified as belonging to different plant species. As stated in the preamble of the proposed rule (Unit VI.C.4.), to meet this requirement a developer may provide a peer-reviewed literature rationale ( e.g., breeding guides, journal articles) instead of generating empirical data to demonstrate that the two plant species are sexually compatible. Therefore, for clarity based on public comment (Unit IV.E.4.a.), the regulatory text regarding sexual compatibility was further modified to replace “demonstrate” with “information to support.”

The second element (40 CFR 174.95(b)) captures information on the pesticidal trait and how it was engineered into the plant. EPA anticipates that this element can be addressed through a narrative description of the intended pesticidal function of the PIP and information on the techniques used to make the genetic modification in the recipient plant ( e.g., the molecular tools used, transformation method). The text was revised from the proposal to also require information on the steps that were taken to ensure that no engineering components ( i.e., PIP inert ingredients) are expected to remain in the final plant product. Engineering components include, but are not limited to, those associated with the genetic engineering of the plant itself ( e.g., Cas protein) and selectable markers that, in the early steps of PIP development, aid in the selection of plant transformants that contain the desired traits ( e.g., herbicide resistant markers). Unless the engineering components themselves meet the requirements at 40 CFR 174.705, they would not be exempt inert ingredients. Thus, by requiring this information, EPA will be able to ensure that no unapproved inert ingredients are expected to remain in the final plant product. Similarly, based on public comment (Unit IV.A.2.), EPA has also included a requirement that the developer describe the measures taken to maximize the likelihood that the modification to the recipient plant is limited to the intended modification, including ensuring off-target mutations were minimized ( e.g., through the use of in silico techniques in guide RNA development). This could be information on the specificity of the endonuclease in the recipient plant species and the use of predictive in silico tools that can identify other potential target sites. As discussed in the preamble of the proposed rule (Unit V.A.), by using the definition of a “gene” the Agency restricts any genetic modifications made through biotechnology that would fall under the exemption to modifications to the gene itself. Thus, by requiring this information, EPA can determine that this is true.

The third element (40 CFR 174.95(c)) requires information on the molecular identity of the PIP. Specifically, EPA is requiring the sequence of the PIP in the recipient plant and its comparator. This was revised per public comment to clarify the required sequence information, which is based on the relevant comparator and the type of pesticidal substance (Unit IV.E.4.a.). For example, for native gene insertions the comparator is the sequence of the PIP in the source plant, whereas for native genes that are modified to match corresponding polymorphic site(s), the relevant comparators are the sequence of the PIP in the source plant, the modified recipient plant, and the original native gene in the unmodified recipient plant. What determines the type of sequence information that must be provided is the molecular composition of the pesticidal substance. Nucleic acid sequences must be provided for both native gene insertions and for genes modified to match a corresponding polymorphic site. In addition, if the pesticidal substance is proteinaceous, an amino acid sequence must also be provided. In addition to basic sequence information, if a native allele has been modified according to 40 CFR 174.26(a)(2), then documentation is also required that identifies the modified polymorphic sites within the relevant sequences.

To provide more clarity in response to several comments that were received on the proposal (Unit IV.E.4.b.), EPA has removed the requirement to provide information on the expression profile for those PIPs where the regulatory region has been modified. In the final rule, EPA was able to remove the requirement to provide information on the expression profile because the Agency now includes at 40 CFR 174.26(a) specific criteria related to allowable modifications that could impact expression, thereby restricting expression to what is found in the sexually compatible plant population.

The fourth element (40 CFR 174.95(d)) captures the requirement from proposed 40 CFR 174.95(b) for pesticidal substances that are known allergens or mammalian toxins/toxicants. For these substances, a description of how conventional breeding practices are being used to ensure they do not exceed human dietary safety levels in the recipient food plant must be provided. EPA revised this from the proposed text to specify “human dietary safety levels” rather than “safe levels” for clarity. EPA also added a clarifying parenthetical, “ensure residues of pesticidal substance are not present in food at levels that are injurious or deleterious and are within the ranges of levels generally seen in plant varieties currently on the market and/or known to produce food safe for consumption,” to further define what is meant by “human dietary safety levels.” EPA is aware that the conventional breeding process is generally comprised of three stages: trait mapping, trait introgression, and field testing (Ref. 9). Through genetic engineering, the second stage, trait introgression, can occur more quickly and more precisely ( i.e., insert only the trait of interest without linkage drag of undesirable traits). However, trait mapping (requires knowledge of plant genetics and biology, likely includes an understanding of any naturally occuring plant toxins) and field testing (evaluates traits related to agronomic parameters, consumer preferences, allergens/toxins/nutrition) are expected to still occur under their normal timeframes. The second component of this section is specific to those PIPs that are from a source plant that is a wild relative, i.e., a non-domesticated relative. 40 CFR 174.95(d)(2) is new and was added as a result of comments that the Agency received on the proposed rule (Unit IV.E.4.a.). For PIPs from wild relatives, a rationale as to why they do not pose a hazard to humans or the environment must be submitted. Several examples of the type of information that can be used to address this requirement are provided in the regulatory text itself.

Information described under elements one through four will inform whether the PIP meets criteria (a) and (b) of the FIFRA exemption and criteria (a) and (b) of the FFDCA exemption for the requirement of a tolerance for residues of PIPs.

This rule also finalizes the documentation needed for an exemption for “loss-of-function PIPs.” As discussed in Unit III.B., “loss-of-function PIPs” have now been removed as a subcategory from 40 CFR 174.26 and an exemption specific to “loss-of-function PIPs” has been created at 40 CFR 174.27. Consequently, establishment of documentation requirements for this PIP category were necessary (40 CFR 174.96). As the “loss-of-function PIPs” exemption is focused on phenotype rather than specific underlying nucleic acid sequences, the documentation associated with the exemption is similarly focused on the trait. To this end, the identity of the modified plant ( i.e., genus and species) and a description of the pesticidal trait is required (40 CFR 174.96(a)). Along with the description of the pesticidal trait, a description of how the trait was engineered is also required (40 CFR 174.96(b)). This includes a description of the steps that were taken to ensure that no engineering components ( e.g., Cas proteins) are expected to remain in the plant and measures taken to maximize the likelihood that the modification to the recipient plant is limited to the intended modification, including ensuring off-target mutations were minimized ( e.g., through the use of in silico techniques in guide RNA development). This information allows the EPA to ensure the criteria for exemption are met ( e.g., no non-exempt inert ingredients remain in the final plant).

At 40 CFR 174.73, subpart D, EPA is codifying a requirement under FIFRA section 3(a) that any person who is required to submit documentation for the eligibility determination of a PIP under 40 CFR 174.21(d), must maintain documentation of either the request for EPA confirmation or the letter of self-determination (or both, if applicable) along with all supporting documentation for the specific exemption as specified in subpart E. These documents must be maintained for five years starting with the effective date of the exemption. This text is minorly revised from the proposed text for clarity.

This rule finalizes edits to the “General Qualifications for Exemptions” provisions at 40 CFR 174.21 to clarify the applicability of this framework to other PIP exemptions. For paragraph (a), this revision simply clarifies that this paragraph is specific to the active ingredient of the PIP, rather than the PIP as a whole. This is because the definition of a PIP under 40 CFR 174.3 also includes “any inert ingredient,” and inert ingredients are not exempt under subpart B but rather subpart X. In the proposed rule, EPA used the phrase “pesticidal substance” in its proposed revisions to 40 CFR 174.21(a), while in the final rule, the Agency uses the phrase “active ingredient.” The active ingredient definition at 40 CFR 174.3 includes both the genetic material and any pesticidal substance produced ( e.g., a protein). Exemption criteria related to both the genetic material and the pesticidal substance are specified in exemptions under subpart B. As such, the titles for the exemptions in subpart B are similarly codified to specify “active ingredient.”

Paragraph (b) is revised to refer to subpart W, rather than the specific sections and is also revised to specify that the tolerance exemptions apply to the residues of the active ingredient, rather than the PIP as a whole for the same rationale as outlined for the edit to 40 CFR 174.21(a). It should be noted that although paragraph (b) specifies active ingredient, there are separate tolerance exemptions specific to both the residues of the pesticidal substance ( e.g., 40 CFR 174.541) and the genetic material ( i.e., 40 CFR 174.507) under subpart W.

Paragraph (c) is revised to refer to subpart X, rather than the specific section of 40 CFR 174.705.

EPA is also finalizing a new paragraph (d) in section 40 CFR 174.21 to accommodate the exemption eligibility determination process (Unit III.C.) and the recordkeeping requirements (Unit III.D.). This paragraph specifies that for PIPs listed in the subsequent subparagraphs, the exemption is contingent upon compliance with recordkeeping requirements and the eligibility determination process. The addition of paragraph (d) does not impact the exemption under section 40 CFR 174.25 for PIPs from sexually compatible plants through conventional breeding as this exemption is not identified in paragraph (d). EPA made two revisions to 40 CFR 174.21(d) since proposal of the rule. First, the Agency added a clarification that 40 CFR 174.73 is implemented “per sections 8 and 9 of FIFRA (U.S.C. 136f and 136g).” Those sections of FIFRA specify EPA's inspection authority and impose recordkeeping requirements and they still apply to the PIPs exempted under this rule. Secondly, “[Reserved]” was moved to 40 CFR 174.21(d)(3) and replaced in its proposed position at 40 CFR 174.21(d)(2) with “Loss-of-function plant-incorporated protectants,” to accommodate the newly created exemption for these types of PIPs at 40 CFR 174.27.

The rule finalizes clarifications of the relationship between the newly exempted “PIPs created through genetic engineering from a sexually compatible plant” and “loss-of-function PIPs” with the previous FIFRA and FFDCA exemptions related to conventionally bred plants ( i.e., 40 CFR 174.25 and 40 CFR 174.508). EPA inserted “created through conventional breeding” at the end of each section title, and inserted an additional criterion into 40 CFR 174.25 and 40 CFR 174.508, stating that the genetic material is transferred only through conventional breeding. The exemptions at 40 CFR 174.25 and 40 CFR 174.508 have always meant “only through conventional breeding,” but this clarification is necessary given the amended definition for “sexually compatible.”

While EPA revised 40 CFR 174.25 and 40 CFR 174.508 to include a criterion specifying that the genetic material is transferred from the source plant to the recipient plant only through conventional breeding, a parallel revision was not proposed or finalized at 40 CFR 174.705.

The amended definition for “sexually compatible” states that “plants must be capable of forming a viable zygote through the union of two gametes through conventional breeding” (emphasis added), which differs from the definition promulgated in 2001 that specified that “a viable zygote is formed only through the union of two gametes through conventional breeding” (emphasis added). The amendment of the “sexually compatible” definition therefore removes the criterion that the gamete formation may only occur through conventional breeding, which would otherwise preclude the use of genetic engineering to create PIPs that are exempt even if those PIPs are moved between sexually compatible plants. Because EPA is not adding an additional conventional breeding criterion to 40 CFR 174.705, like it is for 40 CFR 174.25 and 40 CFR 174.508, the inert ingredient exemption at 40 CFR 174.705 is no longer bound by conventional breeding and therefore allows for the exemption of inert ingredients that are initiated through biotechnology, so long as they still meet the existing criteria of that section.

EPA received a total of 8,120 comments on the proposed rule. Of those, 28 were unique and one of those unique comments was supported by 8,093 co-signers. Comments were received from private citizens, industry, academia, professional and trade associations, State regulatory associations, and public interest groups. Of the 28 unique comments, twenty-three were generally supportive of an exemption for PIPs created through biotechnology, while three comments, one of which included the mass mailer, were opposed. An additional two respondents commented on specific aspects of the rule while remaining silent as to their overall position on its promulgation.

In this unit, EPA provides a summary of the major issues raised by commenters and EPA's responses, as well as summaries of public comments that prompted changes to the proposed requirements for the final rule. All public comments and EPA's responses, including those that do not raise significant issues or substantially change the proposed requirements, are included in Response to Comments document (Ref. 1).

In the proposed rule, EPA sought comment on whether the intent behind the use of the terms “native” and “never derived” is clear or whether alternative phrasing should be used instead. Most of the commenters that responded to this request stated that EPA's intent was clear but had suggestions on edits to the definitions of “native gene” and “native allele.” A concern raised by several of the commenters was that alleles that emerged from the use of common conventional breeding techniques, such as induced mutagenesis, may be unintentionally excluded from the definition of “native allele.” Thus, some commenters suggested explicitly including the use of induced mutagenesis, embryo rescue, and other conventional breeding techniques in the 40 CFR 174.3 definitions for “native allele,” “native gene,” “sexually compatible,” or “conventional breeding.” Another commenter provided an alternative and suggested to focus on the exclusion of transgenes from the native gene definition more explicitly. EPA agreed with the suggestion to focus on the exclusion of transgenes and revised the definition accordingly (Unit III.A.1.). As stated in the proposal, the Agency does not mean to imply that using the term “native” would exclude genes originated through conventional breeding techniques like mutagenesis. Native genes comprising the gene pool of sexually compatible plant populations have been developed through the processes of mutation, selection, and genetic exchange. Mutations in any part of a gene can occur naturally or may be induced including through chemical mutagenesis used by plant breeders to create new varieties. Alleles found in sexually compatible plants that may have been created through conventional breeding would be included in the definition of “native allele” and “native gene.” Additionally, as the requirement does not specify an allele frequency that must be met to qualify as a native allele, identifying one individual with a particular allele is sufficient to claim an allele as a “native allele.” EPA also notes that there is no time component of the requirement, and so use of a native allele identified in a plant from the 1950s, for example, is permissible so long as that plant species is a species known to be sexually compatible with the recipient plant.

Regarding requests to explicitly list conventional breeding techniques like mutagenesis in one of the definitions, EPA does not find this to be necessary, and listing specific conventional breeding techniques may only serve to further cause confusion. EPA finds that the techniques listed in the conventional breeding definition ( e.g., bridging crosses and wide crosses) focus on the merging of genetic material from different organisms. Therefore, specific conventional breeding techniques, such as induced mutagenesis, are not explicitly included in the “conventional breeding” definition because they are not relevant techniques to the merging of genetic material between organisms.

Two commenters requested that the term “biotechnology” be defined. As the regulations have a definition for “conventional breeding” under 40 CFR 174.3, which forms the basis for the exemption under 40 CFR 174.25, EPA agrees that it would be prudent to similarly provide a definition to inform the exemption under 40 CFR 174.26. Given that USDA's recent revisions to 7 CFR 340 use the phrase “genetic engineering,” EPA chose to define “genetic engineering” rather than “biotechnology,” to provide consistency across the Coordinated Framework (Ref. 3). EPA thusly updated the term used in the exemption title to be “genetic engineering.” EPA used “genetic engineering” and “biotechnology” synonymously in its proposed rule as evidenced by Unit VI.A.3.g. titled “Are there any considerations associated with newer biotechnology techniques?,” where EPA discussed genetic engineering techniques like clustered regularly interspaced short palindromic repeats (CRISPR), zinc-finger nucleases, transcription activator-like effector nucleases, and oligonucleotide-directed mutagenesis.

EPA also received comments requesting the Agency limit the definition of “genetic engineering” and therefore the exemptions at 40 CFR 174.26 and 40 CFR 174.27 to high precision techniques such as CRISPR. The Agency has chosen to adopt a broader definition of “genetic engineering,” which is more consistent with the dictionary definition of the term. Although the exemptions at 40 CFR 174.26 and 40 CFR 174.27 are not restricted to specific genetic engineering techniques, the exemption criteria in the provisions themselves inherently limit the types of techniques which are likely to be used. For example, it is unlikely for a developer to be able to make the modifications described in 40 CFR 174.26(a)(2)(i) or 40 CFR 174.26(a)(2)(ii) using techniques other than high precision technologies.

Commenters also pointed out that such high precision techniques can be used to limit potential off-target effects from genetic engineering. EPA agrees with the commenters that existing gene editing technologies can be used in a manner to limit off-target effects ( e.g., through the use of in silico analyses in guide RNA development), and EPA notes that it is expected that the majority of developers already use these types of techniques (Ref. 10). Rather than explicitly limiting the exemption to specific gene modifying techniques, such as CRISPR, the Agency has added an item in the documentation required for developers in 40 CFR 174.95 to describe the measures taken to maximize the likelihood that the modification to the recipient plant is limited to the intended modification (Unit III.C.4.a.). As noted, it is anticipated that developers are already utilizing basic measures to reduce off-target effects, and as such, EPA does not anticipate that this requirement for a description would be unduly burdensome.

EPA received comments related to various aspects of the name EPA chose for PIPs proposed for exemption under 40 CFR 174.26. One commenter requested that EPA move the clause “created through biotechnology” to directly follow “PIP.” The concern was that the original phrasing of “PIPs based on sexually compatible plants created through biotechnology” may suggest that the plant has been modified to be sexually compatible, rather than the intended requirement that the resulting PIP be based on a PIP from a sexually compatible plant. EPA agreed with this comment and reordered the clauses as suggested for clarity.

EPA received several comments requesting clarification as to whether the presence of “noncoding, nonexpressed nucleotide sequences” would affect the exemption status of a PIP at 40 CFR 174.26(a). Commenters argued that because noncoding, nonexpressed sequences are currently excluded from the definition of “genetic material necessary for the production” at 40 CFR 174.3, their presence in the recipient plant should not affect the exemption status of a PIP that otherwise meets the exemption criteria.

“Noncoding, nonexpressed nucleotide sequences” are defined at 40 CFR 174.3, in part as “nucleotide sequences that are not transcribed and are not involved in gene expression.” One such example are the left and right border sequences that flank the genetic material that is inserted into the plant genome when using Agrobacterium -mediated transformation. These sequences facilitate the integration of the genetic cargo into the plant genome and will remain in the recipient plant together with the genetic material that the developer wishes to express to create the pesticidal trait. Other examples of “noncoding, nonexpressed nucleotide sequences” are linker sequences and restriction enzyme recognition sites.

As discussed in the preamble of the proposed rule, “EPA expects that any ingredients intentionally added during the development of “PIPs created through genetic engineering from a sexually compatible plant” that are specific to the production of the active ingredient ( e.g., guide RNA, DNA nuclease) and that could function as an inert ingredient would either be transiently transformed or would be removed ( e.g., through segregation of the trait) during the breeding process and that if these ingredients have not been removed from the final product the product would not meet the criteria proposed under the new 40 CFR 174.26 and would not qualify for the new exemptions.” Like the inert ingredients cited in this quote, noncoding, nonexpressed sequences are intentionally added during the development of the PIP to facilitate the integration of the genetic cargo. Thus, EPA finds that if these sequences are not removed from the final product, i.e., the recipient plant, they similarly do not meet the criteria for exemption under 40 CFR 174.26 and 40 CFR 174.27. In this way, the PIPs exempted under this rulemaking remain indistinguishable from those created through conventional breeding.

EPA received requests to clarify whether modifications to multiple genes within a single recipient plant would qualify for the exemptions at 40 CFR 174.26. The exemptions at 40 CFR 174.26 and 40 CFR 174.27 do not limit the number of PIPs that can be created in a single recipient plant. Therefore, changes to multiple genes in a single recipient plant are allowed, so long as each resulting PIP individually meets the exemption criteria. In these instances, the M009 PRIA fee for an EPA determination applies to each individual PIP, meaning that if one plant contains multiple unique PIPs, the M009 PRIA fee would apply multiple times ( e.g., the M009 PRIA fee is applied three times for the creation of three unique PIPs in a single recipient plant). The exception is a scenario in which the same gene is modified or inserted multiple times across the genome. For example, it may be necessary to modify several homologous genes of a native gene in a recipient plant to create a single PIP ( i.e., to create a loss-of-function PIP where the trait requires all homologous genes to be modified). Conversely, a developer may wish to insert multiple copies of the same native gene. In the instance of modifying/inserting the same gene multiple times across the genome, the M009 fee is only applied once, as the application contains only one PIP.

EPA received several comments on the “identical substance” criteria stating, amongst other things, that modifications that result in non-identical substances may not result in a change in risk profile and that the requirement for the production of an identical substance is not consistent with the requirements for PIPs from sexually compatible plants that are moved through conventional breeding. In response, EPA has edited the exemption category related to modifications in an existing native gene at 40 CFR 174.26(a)(2) to incorporate the use of polymorphic regions (Unit III.A.2.).

The exemption category at 40 CFR 174.26(a)(2) does not require the production of an identical substance, while still staying within the scope of what could be achieved through conventional breeding and thus within the scope of the proposed rulemaking. The exemption criterion at 40 CFR 174.26(a)(2) now allows for modifications of the existing native gene using a single source plant as a template to match corresponding polymorphic sequence(s) in a native allele of that gene. Polymorphisms are variants of a gene sequence that are shared between native alleles. These genetic variations may be composed of single nucleotides ( i.e., SNPs) or larger DNA segments and they are found at the same locus within the genetic sequence of two or more native alleles (Ref. 11). In some cases, enhanced pesticidal properties of a gene product can be attributed to one or more of these genetic variations within a native gene. 40 CFR 174.26(a)(2) allows developers to utilize their knowledge of specific polymorphisms in native alleles to make changes to the native gene in their recipient plant. While this category does not require the entire substance to be identical to a substance found in the sexually compatible population of the recipient plant, it does require the individual polymorphism(s) to have been identified. It is also important to note that this category requires the use of a single source plant as a template, meaning it is not allowed to combine polymorphisms from multiple native alleles in a single PIP. By requiring the polymorphic sequences to be identical and the use of a single source plant as a template, this separate exemption category allows the Agency to capture more of the possible genetic variation that can occur in plants, while staying within the bounds of what could have been achieved through conventional breeding.

EPA proposed at 40 CFR 174.26(b) a criterion that was intended to ensure that the expression profile of exempted PIPs falls within that which is found in the sexually compatible population. Limiting expression profiles of exempted PIPs in this way is a key limitation to prevent novel environmental and dietary exposures. However, commenters expressed concern over the feasibility to generate the information required to demonstrate eligibility for exemption and had several questions on how these requirements could be met (Unit IV.E.4.b.). Additionally, the Agency received requests to clarify whether the criteria that the pesticidal substance may not be expressed at higher levels, in different tissues, or at different developmental stages, would apply simultaneously or independently. Commenters also requested clarification on the identity of the appropriate comparator for the expression profile criteria at 40 CFR 174.26(b). These comments prompted the Agency to reevaluate the text proposed at 40 CFR 174.26(b).

Given the number of comments received surrounding the expression criteria, and that limiting expression profiles of exempted PIPs is a key limitation to prevent novel environmental and dietary exposures, EPA is not codifying proposed 40 CFR 174.26(b) and is instead finalizing specific criteria at codified 40 CFR 174.26(a) related to the types of permissible modifications that may impact expression. EPA now requires that regulatory regions inserted as part of a native gene per codified 40 CFR 174.26(a)(1), be identical to those found in the native gene in the source plant. The exemption category at 40 CFR 174.26(a)(2) specifies that modifications to an existing native gene, which includes regulatory and coding regions, must match corresponding polymorphic sequence(s) in a native allele. By requiring that inserted regulatory regions match those found in the native gene in the source plant and that modified regulatory regions match polymorphic sequences found in a native allele, EPA can ensure that the expression profile of PIPs exempted under 40 CFR 174.26 will stay within the bounds of what could be obtained through conventional breeding. Furthermore, this criterion coupled with the information on the history of safe use (40 CFR 174.95(d)) allows EPA to ensure that the expression profile of PIPs exempt from the requirement of a tolerance under 40 CFR 174.541 meet the requirement that expression be at levels that are not injurious or deleterious to human health.

EPA received a number of comments questioning whether loss-of-function traits conferring pesticidal effects are considered pesticides under FIFRA. As stated in the preamble of the proposed rule (Ref. 2), EPA considers the modification of existing native genes in a plant that elicit a loss-of-function trait conferring a pesticidal effect, i.e., “loss-of-function PIPs,” to be a pesticide. In the case of “loss-of-function PIPs,” the genetic material of the plant has been altered to reduce or eliminate the activity of a gene that would otherwise facilitate the susceptibility of that plant to a pathogen; therefore, the reduction or elimination of that activity has a mitigating or pesticidal effect.

FIFRA defines a “pesticide,” in relevant part, as “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.” FIFRA section 2(u), 7 U.S.C. 136(u). For “loss-of-function PIPs” (now exempted under 40 CFR 174.27), the modified genetic material, e.g., the modified gene or the genetic material surrounding an excised gene, is the pesticidal substance, since that material operates in the plant to mitigate the pest. Further, the modified genetic material has been modified with the intent to mitigate the pest. Therefore, any plant containing the loss of function trait sold or distributed with pesticidal claims would meet the statutory definition of a pesticide.

Under EPA's regulations, a substance is considered to be intended for a pesticidal purpose if, among other things, the person who distributes or sells the substance as a pesticide product claims, states, or implies that the substance can or should be used as a pesticide; the substance has no significant commercially valuable use other than use for pesticidal purpose; or a person sells or distributes a product with actual or constructive knowledge that the product will be used, or is intended to be used, for a pesticidal purpose. See 40 CFR 152.15. Therefore, products carrying a pesticidal claim, such as stating that the plant variety resists disease, indicate clear pesticidal intent. Further, even if such claims were not made, if the seller or distributor knew that the loss of function trait was contained in the plant, the substance would still be considered to be intended for a pesticidal purpose. Likewise, even for loss-of-function PIPs that result in the complete elimination of activity from the modified genetic material, the intentional modification of the plant's genetic material to result in a pesticidal effect indicates that the developer has actual or constructive knowledge that the substance will be used, or is intended to be used, for a pesticidal purpose and that there is not a significant commercially valuable use other than for a pesticidal purpose. The result is that “loss-of-function PIPs” are subject to regulation under FIFRA. This Final Rule exempts “loss-of-function PIPs” that meet the criteria under 40 CFR 174.27 from certain regulation under FIFRA. Without this exemption, sale and distribution of plants containing those modifications would require registration under FIFRA.

Furthermore, PIPs from sexually compatible plants have been exempt under 40 CFR 174.25 for over 20 years. Had a developer sought confirmation that their conventionally bred, disease-resistant plant was exempt, EPA would have exempted such a product under 40 CFR 174.25 on the basis that it is a PIP trait that has been created via conventional breeding. (See e.g., 66 FR 37772; July 19, 2001 (FRL-6057-7)). This determination would be made without making a distinction of mode of action ( e.g., gene loss-of-function or production of a protein). Disease-resistant traits are often caused by the loss-of-function of a gene, and the 2001 preamble focused on the presence of a pesticidal trait ( i.e., disease resistance) and claims of resistance in its determinations that such a trait would be considered a pesticide and a PIP, indicating that EPA did not make a distinction as to whether the disease-resistant trait was conferred via a gene loss-of-function or via production of a proteinaceous substance. Therefore, it is consistent to consider loss-of-function traits to be both pesticides and PIPs.

EPA received several comments from industry, trade, and academia on the criterion of substance identity, requesting that the exemptions should be broadened to include non-identical pesticidal substances. By creating a separate exemption for “loss-of-function PIPs” with specific criteria and an accompanying definition, EPA finds that “loss-of-function PIPs” as described by 40 CFR 174.27 do not require the “identical substance” criterion, as do PIPs exempt under 40 CFR 174.26, due to fundamental differences in the pesticidal activity of “loss-of-function PIPs” compared to PIPs exempt under 40 CFR 174.26.

“Loss-of-function PIPs” are characterized by a modification that leads to the reduction or elimination of the activity of that gene, which then results in a pesticidal trait ( e.g., the inactivation of a gene coding for a plant receptor confers disease resistance). Mutations that lead to a loss of gene function occur naturally and are prevalent within many organisms, including plants. For example, one study of 1,071 genomes of the model plant Arabidopsis thaliana showed a total of 60,819 loss-of-function variants within 12,907 genes, out of a genome-wide total of approximately 25,500 genes (Refs. 12, 13). In addition to their natural occurrence as a result of various biotic and abiotic factors, plant breeders have intentionally induced these types of mutations during the conventional breeding process. One example is the treatment of seeds by chemical mutagens, which is a technique used by breeders to create new plant varieties (Refs. 14, 15).

The traits that may result from the loss of function of a gene are diverse, ranging from altered grain size, increased drought tolerance, and resistance to plant diseases (Refs. 16-20). Disease resistance in plants from the loss of function of S-genes (susceptibility genes) have been identified in natural plant populations, and researchers have used knowledge about naturally occurring gene variants to create pest resistance in various plant species using genetic engineering (Refs. 18, 19). For example, genetically engineered deletions in parts of the regulatory region of the SWEET14 gene in rice created a plant line that is resistant to the Xanthomonas oryzae pv. oryzae ( Xoo ) pathogen, and genetically engineered loss-of-function of eIF4E achieved potyvirus resistance in cucumber (Refs. 21, 22).

As previously stated, EPA does not require an “identical substance” criterion for “loss-of-function PIPs,” and this is because mutations in any part of a gene have the potential to result in the loss of its function. Examples include deletions within the regulatory region that lead to the reduced expression (and thus reduced abundance) of an unmodified protein, or a single nucleotide change in the coding region, which can result in the creation of a premature stop codon, leading to the production of a shorter version of the protein originally encoded by that gene. Other changes to the coding region may also lead to mis-splicing of the pre-mRNA, which can subsequently result in the degradation of the pre-mRNA (no protein produced) or the production of a non-functional protein (Refs. 23, 24). If a non-functional protein is produced, a normal part of routine biological processes is for the cell to recognize it as such and target it for degradation into its amino acid constituents. This turnover of protein occurs independent of how the non-functional protein was created, be it the result from a permanent genetic change (either through natural or induced mutation) or errors created when cells transcribe and/or translate the genetic code (Refs. 25-28). The ability of the cell to recognize and break down non-functional proteins is a routine cell function, and it enables the organism to be economical with its resources by reusing the amino acids for those proteins that do serve a purpose.

Based on the prevalence of loss-of-function mutations in plants and the biological considerations of protein homeostasis, EPA finds that it does not need the same requirements on characteristics as it does for “PIPs created through genetic engineering from a sexually compatible plant.” Therefore, “loss-of-function PIPs,” as exempted under 40 CFR 174.27, are still supported by the risk assessment as presented in the proposed rule.

As the “loss-of-function PIP” exemption is focused on function, there is no nucleic acid sequence requirement in the exemption criteria under 40 CFR 174.27 or in the exemption documentation under 40 CFR 174.96. Commenters have stated a concern that minor crops may face a disadvantage due to fewer genomic resources being available for their specific crop species. For example, one commenter stated that knowledge of genes in major crops or model organisms can inform the development of minor crops due to conserved gene function from a shared common ancestor, even when those plants are no longer sexually compatible. EPA believes that the codified exemption for “loss-of-function PIPs” with its focus on function will allow for use of this knowledge and provide a benefit for developers, including those of minor crops.

In the proposal, all exempted “PIPs created through genetic engineering from a sexually compatible plant” had the option of self-determination. However, in the final rule, only developers of “loss-of-function PIPs” (40 CFR 174.27) have the option to self-determine whether the exemption criteria are met.

The Agency finds the approach to require an EPA confirmation for “PIPs created through genetic engineering from sexually compatible plants” justified. Commenters felt that a mandatory EPA confirmation process would prevent an incorrect exemption determination. EPA agrees with commenters arguing that doing so will provide additional clarity to developers of “PIPs created through genetic engineering from sexually compatible plants” and increase transparency and public trust in products containing these PIPs.

Other commenters were supportive of the flexibility that a mandatory self-determination process with a voluntary EPA confirmation process would provide. EPA acknowledges the value of this flexibility and has determined that developers of “loss-of-function PIPs” will have the option to either self-determine or request EPA confirmation of exemption eligibility. Given the straightforward nature of the criteria describing “loss-of-function PIPs” ( i.e., a focus on function rather than source plant or underlying sequence), EPA believes it appropriate for “loss-of-function PIPs” to be eligible for the self-determination option as it is unlikely for a developer to accidentally mis-determine these PIPs. Furthermore, the mode of action of “loss-of-function PIPs” ( i.e., reduction or elimination of an endogenous gene) is fundamentally different from “PIPs created through genetic engineering from a sexually compatible plant” ( e.g., intentional production of a pesticidal protein), and as such, further lends itself to the availability of a self-determination option.

Commenters were largely supportive of the option to transfer the exemption status of a particular PIP to other plant varieties. Regarding this option, one commenter felt that the criterion in the proposal at 40 CFR 174.90(e)(1)(ii) that required that the same phenotype be created through non-homologous end joining repair modifications was too narrow. EPA agreed with this comment and, given the creation of a separate exemption for “loss-of-function PIPs” focused on function, was able to revise the exemption extension criteria for “loss-of-function PIPs” to be similarly focused on function (Unit III.C.1.).

In the proposal, EPA proposed to require submitters of self-determination letters to identify the PIP (at proposed 40 CFR 174.91(b)(2) and 40 CFR 174.91(b)(3)). Two commenters stated that EPA should require additional information on the PIP with the submission of a self-determination letter. Specifically, it was requested that EPA require information on the plant species, a description of the pesticidal trait, and a short summary of how the pesticidal trait was introduced into the plant variety. It was also requested that EPA require developers to submit information that would be required for an EPA confirmation. EPA agrees that information on the recipient plant species and a unique gene identifier should be included in the self-determination letter and has updated the text at 40 CFR 174.91 to reflect this (Unit III.C.2.). Because the identity of the PIP may or may not include the name of the modified gene or plant species ( e.g., the identity of the PIP could also be a trade name), the Agency has clarified that a gene identifier and the identity of the recipient plant must also be included in the submission of a self-determination letter.

Regarding the other suggestions, such as a description of the pesticidal trait, a short summary of how the trait was introduced, and other information otherwise provided to the Agency as part of the EPA confirmation process, the Agency does not find this information necessary to be submitted with the self-determination letter. This is because the self-determination process does not involve an EPA review or confirmation. However, the information provided during an EPA confirmation is the same information required to be maintained by the recordkeeping requirements under 40 CFR 174.73, which equally applies to those submitting a self-determination of exemption. As part of the recordkeeping requirements, the information suggested by the commenters must already be made available to EPA upon request. Although the Agency is not requiring a summary description of the pesticidal trait and how it was introduced in the self-determination letter, the Agency agrees that identifying the trait type ( e.g., insect resistance or disease resistance) would provide useful information for the public and for State level agencies and edited 40 CFR 174.91(b)(2) to reflect this. Thus, the language at 40 CFR 174.91(b)(2) now requires information on plant species, gene identifier, and trait type.

EPA received comments on the scope of the documentation that is required to be produced to support an exemption for “PIPs created through genetic engineering from a sexually compatible plant.” One commenter requested that, in addition to discussing the categories of information needed to assess applicability of the exemption to a PIP, EPA furthermore establish expectations in the regulatory text on what information the Agency deems sufficient to satisfy each of the exemption criteria. In line with this, one commenter suggested to revise 40 CFR 174.95(a)(2) to replace “information to demonstrate the recipient plant and the source plant are sexually compatible” with “information to support that the recipient plant and the source plant are sexually compatible.” The Agency agrees with this suggestion as a developer may, for example, provide a peer-reviewed literature rationale instead of generating empirical data to demonstrate that two plants are sexually compatible. The Agency revised the regulatory text in the final rule accordingly (Unit III.C.4.a.).

The same commenter also suggested two revisions to 40 CFR 174.95(c)(1). First, the commenter suggested that the documentation requirements should limit sequence comparison to nucleic acids, rather than require both the nucleic acid and the amino acid sequence for proteinaceous PIPs and to limit the nucleic acid sequence comparison to the location of the intended modification(s) rather than the entire PIP. Second, the commenter requested that if an amino acid sequence was required, EPA further clarify the language on the sequence requirements to state “nucleotide sequence and deduced amino acid sequence.” EPA has revised the text at 40 CFR 174.95(c)(1) for increased clarity as to the required sequence information based on the relevant comparator, i.e., the specific comparator at 40 CFR 174.95(c) is now listed based on the corresponding exemption category at 40 CFR 174.26. The Agency maintains that the entire nucleic acid sequence must be provided for all PIPs exempted under 174.26(a), as both exemptions at 40 CFR 174.26(a) allow for modifications in the regulatory regions. Thus, providing EPA with the nucleic acid sequence of the entire gene will allow the determination if the modifications meet the exemption requirements (Unit III.C.4.a.). The Agency maintains that the full-length amino acid sequence must additionally be provided for proteinaceous PIPs but agrees with the commenter that the deduced amino acid sequence would be sufficient to inform the identity of that PIP in these instances.

Commenters requested that EPA exclude wild relatives as potential source plants and/or impose geographic restrictions on source plants, noting that non-target organisms living within the range of the wild donor plants would have adapted to exposures from these wild plants and that non-target organisms from outside this range may therefore be negatively impacted by a PIP from the wild plant due to lack of previous exposure. Additionally, it was noted that allowing sexually compatible wild relatives as source plants may result in toxins from these plants being missed as part of the plant breeder screening.

EPA understands that wild relatives provide an important source of genetic variation for developers and therefore has chosen not to exclude them from use as sexually compatible source plants for exempt PIPs. However, to address the concern raised by the commenters, EPA has added a requirement at 40 CFR 174.95(d)(2) that if the source plant is a wild relative of the recipient plant, the developer must describe why the PIP is not anticipated to pose a hazard to humans or the environment. EPA provides a list in the regulatory text at 40 CFR 174.95(d)(2) of the types of information that can be used to describe why a PIP is not anticipated to pose a hazard to humans or the environment.

EPA received several comments on the proposed rule regarding the PIP expression criteria at 40 CFR 174.26(b) and the associated documentation requirements at 40 CFR 174.95(c)(2). Several commenters raised concerns that meeting the documentation requirements would be impractical and cost prohibitive given the large variation in plant gene expression between tissues and growth stages, especially when considering gene expression in different environmental conditions. One commenter submitted that data to meet the expression limitation exemption criteria should only be required if the intent of the modification is to increase levels of the expressed pesticidal substance. This approach is consistent with the Agency's analysis of gene expression articulated in the proposal. Specifically, EPA found that although variations in the production of plant substances will occur in response to environmental conditions, there are physiological and practical considerations that limit the expression level, and thus the abundance of a particular substance in plants that are sexually compatible. EPA finds that this is especially true for regulatory regions and polymorphic sequences that are present in regulatory regions that are moved between native alleles. In other words, there is the expectation that the expression pattern of a PIP would be within that what is found within the sexually compatible population, so long as it is under the control of the regulatory elements found within a native allele.

Consistent with this assessment and taking into consideration the comments received on the impracticality and potential financial burden of determining the expression levels to comply with proposed 40 CFR 174.95(c)(2), the Agency removed the exemption criterion at proposed 40 CFR 174.26(a)(2)(i) that would have allowed modifications to regulatory regions for the purpose of altering the expression level of a pesticidal substance. Instead, EPA is now requiring at 40 CFR 174.26(a)(1) that any regulatory region that is inserted as part of a native gene must be identical in nucleotide sequence to the regulatory region of the native gene as it is identified in the source plant. Similarly, 40 CFR 174.26(a)(2) allows regulatory region changes only based on polymorphic sequence(s) identified in a native allele of the modified gene. In making these revisions to 40 CFR 174.26, EPA is able to remove the requirements for expression profile confirmation at proposed 40 CFR 174.95(c)(2), as the expectation is that the expression profiles of PIPs that meet these exemption criteria at 40 CFR 174.26(a) will not be outside of that what is found within the sexually compatible population of the recipient plant.

Two commenters requested clarification on which activities may require a separate notification of self-determination for a PIP under 40 CFR 174.541. Specifically, commenters requested clarification in those instances in which a plant containing the PIP is imported to the United States for the distribution in commerce for consumption or planting in the absence of a tolerance or tolerance exemption granted under FFDCA.

EPA is confirming that the Agency is requiring a separate eligibility determination under 40 CFR 174.541 for residues of those PIPs that are imported into the United States and that are used for food or feed if the developer has not already obtained an exemption under 40 CFR 174.21. As discussed in the preamble of the proposed rule, a separate submission of the eligibility determination of the FFDCA exemption for a PIP proposed for use in food or feed is required only if it has not already been submitted under FIFRA. To clarify, EPA has added a new paragraph (g) to 40 CFR 174.90, which explains that a duplicative eligibility submission is not required for purposes of 40 CFR 174.541(c), if it is already being submitted for purposes of 40 CFR 174.21(d). The proposal discussed one such scenario where this might be the case ( e.g., Unit VI.C.1. of the proposed rule). Briefly, a developer will need an exemption eligibility determination for the purposes of FFDCA but not FIFRA when residues of a PIP will be in or on food imported into the United States, but the PIP is not intended to be sold or distributed for pesticidal use ( e.g., PIP containing seed or plant sold for planting) in the United States. In that case, the PIP residues in the imported food would need a tolerance or tolerance exemption to allow for distribution in interstate commerce in the United States under the FFDCA, but would not need a FIFRA exemption since it is not intended to be sold or distributed for pesticidal purposes in the United States.

Other commenters inquired whether testing of PIPs at or under 10 acres of land would require an Experimental Use Permit (EUP) under FIFRA section 5 and therefore whether an eligibility determination for certain PIPs would be required at these acreages. 40 CFR 172.3 applies to PIPs. As described in 40 CFR 172.3, tests on 10 acres or less are presumed to not require an EUP so long as any food or feed crops involved in, or affected by, such tests (including, but not limited to, crops subsequently grown on such land which may reasonably be expected to contain residues of the tested pesticides) are destroyed or consumed only by experimental animals unless an appropriate tolerance or exemption from a tolerance has been established under FFDCA for residues of the pesticide. Further, pursuant to 40 CFR 172.3(e), EPA may, on a case-by-case basis, require that testing be carried out under an EUP even if such testing involves 10 acres or less. For a PIP subject to this rulemaking that would be used in testing taking place on 10 acres or less to be able to take advantage of the presumption in 40 CFR 172.3, that PIP would need to either demonstrate that the appropriate tolerance or exemption has been established or follow the requirements of crop destruction. Pursuant to subpart E of 40 CFR 174 as codified in this rule, for PIPs exempted under 40 CFR 174.26, demonstrating that the tolerance exemption at section 40 CFR 174.541 applied would require an EPA confirmation, and for PIPs exempted under 40 CFR 174.27, it would require the submission of a self-determination. For a PIP for which a tolerance exemption has not been established, in addition to requirements of crop destruction for field testing at or under 10 acres, EPA previously published and still relies on guidance (Ref. 29) detailing containment measures to restrict the flow of genetic material, including seeds, from field tests to minimize the potential for PIP residues that do not have a tolerance exemption to enter the food supply. These additional considerations are crucial to prevent PIPs lacking a tolerance exemption from entering the food supply and the consequences of adulteration under FFDCA. EPA notes that it is expecting to provide an update to the information and/or process provided in PRN 2007-2 (Ref. 29) regarding measures needed for containing small-scale testing of PIPs in light of changes in regulatory oversight due to USDA's recently revised 7 CFR part 340 regulations.

Several commenters noted that information included in a request for EPA confirmation may be classified as CBI and requested assurance and clarification for how EPA would protect intellectual property and other proprietary information. As EPA is using its existing electronic reporting site for receiving submissions, this information will be transmitted to EPA in a secure manner. As stated in 40 CFR 174.90(c), any claims of confidentiality for information submitted in the request for EPA confirmation must be made in accordance with the procedures outlined in 40 CFR 174.9 of subpart A. 40 CFR 174.9 instructs a submitter on how to claim data or other information as CBI. Information likely to be claimed as CBI may be part of the documentation for an exemption ( e.g., sequence information on the pesticidal substance). Developers also have the option to claim information submitted as part of the self-determination as CBI ( e.g., gene ID, plant species). However, it is important to note that every individual piece of information claimed as CBI must be supported by its own substantiation. For this reason, and for reasons of public transparency, as it has for all PIPs, EPA continues to encourage PIP developers to limit their claims to CBI to only the most pertinent pieces of information.

EPA received public comment regarding whether the proposed exemption may affect endangered species. EPA determined that this action invokes obligations under the Endangered Species Act because this is a discretionary action that exempts certain pesticidal substances from some requirements under FIFRA, such that the exemptions could cause potential exposures in the environment. Therefore, EPA conducted an Endangered Species Assessment for “PIPs created through genetic engineering from a sexually compatible plant” and for “loss-of-function PIPs.”

In the proposed rule, after careful consideration of potential interactions that the PIPs proposed for exemption may have with nontarget organisms (see Unit VI.A.3. of the proposed rule), EPA preliminarily determined that use of the PIPs proposed for exemption is not likely to cause unreasonable adverse effects on the environment and humans in the absence of regulatory oversight (although “regulatory oversight” still exists in the form of the adverse effects reporting requirement in existing 40 CFR 174.71) resulting in a reasonable expectation that no discernible effects to nontarget organisms will occur. As no discernible effects to nontarget organisms are reasonably expected to occur due to the use of these PIPs, which necessarily includes any threatened or endangered species (listed species), EPA therefore reaches a ”No Effect” determination for listed species and their critical habitats.

Herein, EPA provides brief summaries of key considerations used in the Agency's determination that the PIP exemptions proposed in the 2020 preamble and finalized in this rule are reasonably expected to result in no discernable effects to nontarget organisms, including listed species. In the proposed rule, EPA considered several factors in determining whether PIPs that meet the criteria under proposed 40 CFR 174.26 could be exempted from FIFRA requirements in order to meet the 40 CFR 174.21(a) requirement (Unit VI.A.3.h. of the proposed rule). In its assessment, the Agency relied on the large body of knowledge that currently exists on sexually compatible plants and genetic diversity. Briefly, with regard to the potential ecological effects, the Agency found that there is: “(1) Low potential for novel exposures; (2) Low potential for levels of “PIPs created through genetic engineering from a sexually compatible plant” to exceed levels found in sexually compatible plants; and (3) Low potential for “PIPs created through genetic engineering from a sexually compatible plant” to move from cultivated plants to wild or weedy relatives through gene flow and increase weediness.” (Unit VI.A.3. of the proposed rule). EPA also evaluated considerations specific to newer biotechnology techniques related to the PIPs proposed for exemption and found that their use in creating these PIPs would pose negligible risk to the environment. Lastly, the Agency found that the likelihood is negligible that the transfer of a PIP via biotechnology from a nonagricultural (wild) relative to an agricultural one would pose a greater risk than if it were transferred through conventional breeding.

In summary, PIPs that are exempted under 40 CFR 174.26 represent a subset of substances already present in related plants and are equivalent both in identity and in expression profile (how much, where, and when the substances are expressed in plants). As “loss-of-function PIPs” exempted under 40 CFR 174.27 were originally proposed as a subcategory of PIPs exempted under 40 CFR 174.26, they too fall within the scope of the Agency's analysis in the proposed rule preamble. Pesticidal traits resulting from the loss-of-function of an endogenous gene are common occurrences in wild plants and in conventional breeding (Refs. 18, 19) and EPA finds that there is no potential for novel exposures or hazards for “loss-of-function PIPs,” as this group of PIPs is characterized by a modification that leads to the reduction or elimination of the activity of a gene that had already been present in the recipient plant. As the PIPs exempted under this rule are considered to be equivalent to those already found in nature and used in conventional breeding, there is a reasonable expectation that no discernible effects to listed species will occur from their use. As no discernible effects are reasonably expected to occur to listed species due to the use of these PIPs, EPA therefore reaches a ”No Effect” determination for listed species and their critical habitats.

The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the person listed under FOR FURTHER INFORMATION CONTACT .

In FR Doc. 2023-07115 of April 12, 2023 (88 FR 22120), there were a number of technical errors that are identified and corrected in this correcting document. The provisions in this correction document are effective as if they had been included in the document published April 12, 2023. Accordingly, the corrections are effective June 5, 2023.

On page 22134, we inadvertently omitted § 422.514(d)(1) from the list of sections finalized.

On page 22135, we made errors in our discussion of the effective dates for the changes to the general enrollment period (GEP) made by the Consolidated Appropriations Act, 2021, and the Part D special enrollment period (SEP).

On page 22150, we made a typographical error in a regulatory reference.

On page 22226, we made a typographical error when specifying a term.

On page 22300, we made a technical error regarding an acronym.

On page 22336 in § 422.2267(a)(3), we made a typographical error.

On page 22341 in § 423.2264 we made a typographical error and technical errors in regulations text regarding election periods and third-party marketing.

On page 22344 in § 423.2536(c), we made a typographical error in a reference.

On page 22345 in § 460.70, we made a--typographical error in a paragraph designation; technical error in the use of an acronym; and technical error in the use of a term.

We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule in accordance with 5 U.S.C. 553(b) of the Administrative Procedure Act (APA). The notice of proposed rulemaking includes a reference to the legal authority under which the rule is proposed, and the terms and substances of the proposed rule or a description of the subjects and issues involved. This procedure can be waived, however, if an agency finds good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued.

We believe that this final rule correcting document does not constitute a rule that would be subject to the notice and comment or delayed effective date requirements. This document merely corrects typographical and technical errors in the final rule, but it does not make substantive changes to the policies or the implementing regulations that were adopted in the final rule. As a result, this final rule correcting document is intended to ensure that the information in the final rule accurately reflects the policies and regulatory amendments adopted in that document.

In addition, even if this were a rule to which the notice and comment procedures and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the minor corrections in this document into the final rule or delaying the effective date would be unnecessary, as we are not altering our policies or regulatory changes, but rather, we are simply implementing correctly the policies and regulatory changes that we previously proposed, requested comment on, and subsequently finalized. This final rule correcting document is intended solely to ensure that the final rule accurately reflects these policies and regulatory changes. Furthermore, such notice and comment procedures would be contrary to the public interest because it is in the public's interest to ensure that the final rule accurately reflects our policies and regulatory changes. Therefore, we believe we have good cause to waive the notice and comment and effective date requirements.

In FR Doc. 2023-07115 of April 12, 2023 (88 FR 22120), make the following corrections:

1. On page 22134, third column, third full paragraph, line 7, the reference “422.514(g)” is corrected to read “422.514(d)(1) and (g)”.

2. On page 22135, first column, second full paragraph, lines 4 and 5, the phrase “provide that on” is corrected to read, “provide that for GEPs on”.

3. On 22150, first column, sixth full paragraph, lines 6 and 7, the reference “§ 423.2508(d)(1) through (5)” is corrected to read “§ 423.2508(c)(1) through (5)”.

4. On page 22226, third column, third full paragraph, line 6, the phrase “anon-English” is corrected to read “a non-English”.

5. On page 22300, third column, first full paragraph, line 28, the phrase “and the SAA,” is corrected to read “and the State administering agency (SAA),”.

This final rule reflects the administrative action of changing the street addresses of the Colorado State Office, including the Public Room, of the BLM. This rule changes the postal and street address for the personal filing of documents relating to public lands in Colorado but makes no other changes in filing requirements. The BLM has determined that the rule has no substantive impact on the public, imposes no costs, and merely updates a list of addresses included in the Code of Federal Regulations for the convenience of the public. The Department of the Interior, therefore, for good cause finds that under 5 U.S.C. 553(b)(B), notice and public comment procedures are unnecessary.

This final rule is an administrative action to change the address for one BLM State Office. This rule was not subject to review by the Office of Management and Budget under Executive Order 12866. The rule imposes no costs, and merely updates a list of addresses included in the Code of Federal Regulations for the convenience of the public.

The BLM has found that the final rule is of a procedural nature and thus is categorically excluded from further documentation under the National Environmental Policy Act of 1969 in accordance with 43 CFR 46.210(i). In addition, the final rule does not present any of the 12 extraordinary circumstances listed at 43 CFR 46.215.

Congress enacted the Regulatory Flexibility Act of 1980 (5 U.S.C. 601, et seq. ) to ensure that Government regulations do not unnecessarily or disproportionately burden small entities. This final rule is a purely administrative regulatory action having no effects upon the public or the environment, and it has been determined that the rule will not have a significant effect on the economy or small entities.

This final rule is a purely administrative regulatory action having no effects upon the public or the economy. This is not a major rule under the Congressional Review Act (5 U.S.C. 804(2)). The rule will not have an annual effect on the economy of $100 million or more. The rule will not cause a major increase in costs of prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. The rule will not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to complete with foreign-based enterprises.

The BLM has determined that this final rule is not significant under the Unfunded Mandates Reform Act of 1995 because the rule will not 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 one year. Further, the administrative final rule will not significantly or uniquely affect small governments. It does not require action by any non-Federal government entity. Therefore, the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et. seq. ), is not required.

As required by Executive Order 12630, the Department of the Interior has determined that the rule will not cause a taking of private property. No private property rights will be affected by a rule that merely reports an address change for the Colorado State Office and its Public Room. The Department therefore certifies that this final rule does not represent a governmental action capable of interference with constitutionally protected property rights.

In accordance with Executive Order 13132, the BLM finds that the rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

The final rule does not have substantial direct effects on the States, on the relationship between the national governments and the States, or the distribution of power and the responsibilities among the various levels of government. This administrative final rule does not preempt State law.

This final rule is a purely administrative regulatory action having no effects upon the public and will not unduly burden the judicial system. This final rule meets the requirements of Sections 3(a) and 3(b)(2) of the Executive Order.

In accordance with the Executive Order 13175, the BLM finds that the rule does not include policies that have Tribal implications. This final rule is purely an administrative action having no effects upon the public or the environment, imposing no costs, and merely updates the Colorado State Office and its Public Room addresses included in the Code of Federal Regulations.

In accordance with Executive Order 13211, the BLM has determined that the final rule will not have substantial direct effects on the energy supply, distribution, or use, including a shortfall in supply or price increase. This final rule is a purely administrative action and has no implications under Executive Order 13211.

The Paperwork Reduction Act does not apply because the rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

For the reasons discussed in the preamble, the Bureau of Land Management amends 43 CFR part 1820 as follows:

The Federal Communications Commission (Commission) adopted amendments to 47 CFR 54.403(a)(3), 54.413, and 54.414(b) that were to become effective upon announcement in the Federal Register of OMB information collection approval (83 FR 2075, January 16, 2018) (FR Doc. 2018-00152). These amended rules were vacated by the Court of Appeals for the D.C. Circuit in National Lifeline Association v. Federal Communications Commission . 921 F.3d 1102. Accordingly, revisions to § 54.403(a)(3), third column on page 2084; § 54.413, first column on page 2085; and § 54.414(b), second column on page 2085 are being withdrawn and these rules are reverting back to their prior version.

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 54 to read as follows:

Background

The transboundary stock of Pacific whiting is managed through the Agreement Between the Government of the United States of America and the Government of Canada on Pacific Hake/Whiting of 2003 (Agreement). The Agreement establishes bilateral management bodies to implement the terms of the Agreement, including the Joint Management Committee (JMC), which recommends the annual catch level for Pacific whiting. NMFS issued a proposed rule on April 06, 2023 (88 FR 20457), that describes the Agreement, including the establishment of F-40 percent default harvest rate, the explicit allocation of Pacific whiting coastwide total allowable catch (TAC) to the United States (73.88 percent) and Canada (26.12 percent), the bilateral bodies to implement the terms of the Agreement, including the Joint Management Committee (JMC), and the process used to determine the coastwide TAC under the Agreement, including adjusting the TAC for carryovers from the prior year. The proposed rule also proposed allocating 17.5 percent of the U.S. TAC of Pacific whiting for 2023 to Pacific Coast Indian tribes that have a treaty right to harvest groundfish, and implementing a set-aside (750 metric tons (mt)) for Pacific whiting for research and incidental mortality in other fisheries.

The Treaty's Advisory Panel (AP) and JMC met in Vancouver, British Columbia, Canada February 28-March 1, 2023, to develop advice on a 2023 coastwide TAC. The AP provided its 2023 TAC recommendation to the JMC on March 1, 2023. The JMC reviewed the advice of the AP, as well the Treaty's Joint Technical Committee, and Science Review Group, and agreed on a TAC recommendation for transmittal to the United States and Canadian Governments.

The Agreement directs the JMC to base the catch limit recommendation on the default harvest rate unless scientific evidence demonstrates that a different rate is necessary to sustain the offshore Pacific whiting resource. After consideration of the 2023 stock assessment and other relevant scientific information, the JMC did not use the default harvest rate, and instead agreed on a more conservative approach. There were two primary reasons for choosing a TAC well below the level of F-40 percent. First, the JMC noted aging of the 2010, 2014, and 2016 year classes and wished to extend access to these stocks as long as possible, which a lower TAC would accomplish by lowering the rate of removal of these year-classes. Second, there is uncertainty regarding the current size of the apparent large 2020 year class because there has not yet been a post-recruitment observation of this cohort by an acoustic survey. The JMC recommended a moderate increase in the TAC, rather than a large increase up to the full F-40 percent harvest rate until a more certain estimate of the year class's size is available after one more year of fishing data, and conclusion of the 2023 acoustic survey.

This conservative TAC setting process, endorsed by the AP, resulted in a TAC that is less than what it would be using the default harvest rate under the Agreement.

The JMC agreed on a recommended and adjusted coastwide TAC of 625,000 mt, of Pacific whiting, which resulted in a U.S. TAC of 461,750 mt (73.88 percent of 625,000 mt). This recommendation is consistent with the best available scientific information, provisions of the Agreement, and the Pacific Whiting Act of 2006 (Whiting Act). The recommendation was transmitted via letter to the United States and Canadian Governments on March 2, 2023. Consistent with the Agreement, the Department of Commerce consulted with the Department of State on the recommended TAC. In a written communication to the NMFS West Coast Region on March 17, 2023, the State Department concurred with the NMFS recommendation to accept the JMC recommended adjusted TAC for 2023. NMFS, under delegation of authority from the Secretary of Commerce, approved the adjusted TAC recommendation of 461,750 mt for U.S. fisheries on March 23, 2023.

This final rule announces the adjusted coastwide TAC of 625,000 mt and adjusted U.S. TAC of 461,750 mt, and implements the domestic 2023 Pacific whiting harvest specifications, including, the 2023 tribal allocation of 80,806 mt, the preliminary allocations for three non-tribal commercial whiting sectors, and a set-aside for incidental mortality in research activities and non-groundfish) fisheries ( e.g., pink shrimp fishery). The tribal and non-tribal allocations for Pacific whiting, as well as the set-aside, are effective until December 31, 2023.

This final rule establishes the tribal allocation of Pacific whiting for 2023 as described in the proposed rule (88 FR 20457). Since 1996, NMFS has been allocating a portion of the U.S. TAC of Pacific whiting to the tribal fishery. Regulations for the Pacific Coast Groundfish Fishery Management Plan (FMP) specify that the tribal allocation is subtracted from the total U.S. Pacific whiting TAC. The tribal Pacific whiting fishery is managed separately from the non-tribal Pacific whiting fishery and is not governed by limited entry or open access regulations or allocations. NMFS is establishing the 2023 tribal allocation as 80,806 mt (17.5 percent of the U.S. TAC) in this final rule.

In 2009, NMFS, the states of Washington and Oregon, and the tribes with treaty rights to harvest Pacific whiting started a process to determine the long-term tribal allocation for Pacific whiting; however, no long-term allocation has been determined. While new scientific information or discussions with the relevant parties may impact that decision, the best available scientific information to date suggests that 80,806 mt is within the likely range of potential treaty right amounts. As with prior tribal Pacific whiting allocations, this final rule is not intended to establish precedent for future Pacific whiting seasons, or for the determination of the total amount of Pacific whiting to which the Tribes are entitled under their treaty right. The long-term tribal treaty amount will be based on further development of scientific information and additional coordination and discussion with and among the coastal tribes and the states of Washington and Oregon.

The U.S. non-tribal whiting fishery is managed under the Council's Pacific Coast Groundfish FMP. Each year, the Council recommends a set-aside of Pacific whiting to accommodate incidental mortality of the fish in research activities and non-groundfish fisheries based on estimates of scientific research catch and estimated bycatch mortality in non-groundfish fisheries. At its November 2022 meeting, the Council recommended an incidental mortality set-aside of 750 mt for 2023. This set-aside is unchanged from the 750 mt set-aside amount for incidental mortality in 2023. Consistent with section 303(c)(2) of the Magnuson-Stevens Fishery Management and Conservation Act (Magnuson-Stevens Act), on November 16, 2022, the Council deemed the proposed regulations for the research and incidental mortality set-aside to be necessary and appropriate to implement the FMP. This final rule will implement the Council's recommendations.

This final rule implements the fishery harvest guideline (HG), also called the non-tribal allocation as described in the proposed rule published on April 06, 2023 (88 FR 20457). The 2023 fishery HG for Pacific whiting is 380,194 mt. This amount was determined by deducting the 80,806 mt tribal allocation and the 750 mt allocation for scientific research catch and fishing mortality in non-groundfish fisheries from the adjusted U.S. TAC of 461,750 mt. Federal regulations further allocate the fishery HG among the three non-tribal sectors of the Pacific whiting fishery: The catcher/processor (C/P) Co-op Program, the Mothership (MS) Co-op Program, and the Shorebased Individual Fishing Quota (IFQ) Program. The C/P Co-op Program is allocated 34 percent (129,265 mt for 2023), the MS Co-op Program is allocated 24 percent (91,246 mt for 2023), and the Shorebased IFQ Program is allocated 42 percent (159,681 mt for 2023). The fishery south of 42° N lat. may not take more than 7,984 mt (5 percent of the Shorebased IFQ Program allocation) prior to May 1, the start of the primary Pacific whiting season north of 42° N lat.

This rule would be implemented under the statutory and regulatory authority of sections 304(b) and 305(d) of the Magnuson-Stevens Act, the Whiting Act, the regulations governing the groundfish fishery at 50 CFR 660.5 through 660.360, and other applicable laws. Additionally, with this final rule, NMFS, will ensure that the fishery is managed in a manner consistent with treaty rights of four Treaty Tribes to fish in their “usual and accustomed grounds and stations” in common with non-tribal citizens. United States v. Washington, 384 F. Supp. 313 (W.D. 1974).

NMFS issued a proposed rule on April 6, 2023 (88 FR 20457). The comment period on the proposed rule closed April 21, 2023. No comments were received during the public comment period.

NMFS has not made any changes to the proposed regulatory text and there are no substantive changes from the proposed rule.

The Administrator, West Coast Region, NMFS, determined that the final rule is necessary for the conservation and management of the Pacific whiting and that it is consistent with sections 304(b) and 305(d), and other provisions of the Magnuson-Stevens Act, the Pacific Coast Groundfish FMP, and other applicable laws.

Pursuant to 5 U.S.C. 553(d)(3), the NMFS Assistant Administrator finds good cause to waive the 30-day delay in the date of effectiveness for this final rule because such a delay would be contrary to the public interest. If this final rule were delayed by 30 days, Pacific coast whiting fishermen would not be able to fish under the final catch limits for Pacific whiting for that time period, and would not be able to realize the full level of economic opportunity this rule provides. Waiving the 30-day delay in the date of effectiveness will allow this final rule to more fully benefit the fishery through increased fishing opportunities as described in the preamble of this rule.

This rulemaking could not be completed prior to the May 1 start date of the 2023 Pacific Whiting primary fishing season due to the short time frame between the approval of the TAC recommendation and the start of the fishing season. The AP and JMC met in Vancouver, British Columbia, Canada on February 28-March 1, 2023, to develop advice on a 2023 coastwide TAC. At this meeting, the JMC agreed on a TAC recommendation, which was transmitted to the United States and Canadian Governments on March 2, 2023. The Department of Commerce consulted with the Department of State on the recommended TAC, and concurred with the NMFS West Coast Region on March 17, 2023 to accept the JMC recommended adjusted TAC for 2023. NMFS, under delegation of authority from the Secretary of Commerce, approved the TAC recommendation U.S. fisheries on March 23, 2023. This rulemaking was proceeded once the JMC agreed on a recommended coastwide TAC, and the Department of Commerce in consultation with the Department of State reviewed and approved the recommended U.S. TAC. The proposed rule published on April 6, 2023 and the public comment period closed on April 21, 2023 (88 FR 20457). The 2023 Pacific whiting primary fishing season began shortly thereafter on May 1, 2023.

In addition, because this rule increases catch limits for Pacific whiting compared to the interim allocation the fishery is currently operating under, it therefore finds good cause to waive the 30-day delay in the date of effectiveness requirement. The Pacific whiting fishery season began fishing on May 01, 2023 under interim allocations based on the lowest coastwide TAC considered in the proposed rule. This final rule implements a higher TAC for Pacific whiting than the interim allocation provided prior to the season opening, and implementing the rule upon publication provides the whiting fleet more opportunity and greater flexibility to harvest the optimal yield. Timely implementation of the full TAC will avoid the need to pause the Pacific whiting fishery if the interim allocations are fully harvested. Additionally, many vessels in the Pacific Whiting fishery also participate in the Alaskan Pollock fishery. Issuing complete 2023 whiting allocations to quota owners in a timely fashion ensures they can plan their participation for the year in both the Pacific Whiting and Alaskan Pollock fisheries.

Waiving the 30-day delay in effectiveness will not have a negative impact on any entities, as there are no new compliance requirements or other burdens placed on the fishing community with this rule. Making this rule effective immediately would also serve the best interests of the public because it will allow for the longest possible fishing season for Pacific whiting and therefore the best possible economic outcome for those whose livelihoods depend on this fishery.

The Office of Management and Budget has determined that this final rule is not significant for purposes of Executive Order 12866.

A range of potential total harvest levels for Pacific whiting have been considered under the Final Environmental Impact Statement for Harvest Specifications and Management Measures for 2015-2016 and Biennial Periods thereafter (2015/16 FEIS) and in the Amendment 30 to the Pacific Coast Groundfish Fishery Management Plan, 2023-2024 Harvest Specifications, and Management Measures Environmental Assessment (EA) and Regulatory Impact Review (RIR) and is available from NMFS (see ADDRESSES ). The 2015/16 FEIS examined the harvest specifications and management measures for 2015-16 and 10 year projections for routinely adjusted harvest specifications and management measures. The 10 year projections were produced to evaluate the impacts of the ongoing implementation of harvest specifications and management measures and to evaluate the impacts of the routine adjustments that are the main component of each biennial cycle. The EA for the 2023-24 cycle tiers from the 2015/16 FEIS and focuses on the harvest specifications and management measures that were not within the scope of the 10 year projections in the 2015/16 FEIS.

NMFS issued a proposed rule on April 6, 2023 (88 FR 20457), for the 2023 Harvest Specifications for Pacific Whiting, and 2023 tribal allocation for Pacific whiting. An Initial Regulatory Flexibility Analysis (IRFA) was prepared and summarized in the Classification section of the preamble to the proposed rule. The comment period on the proposed rule closed April 21, 2023. NMFS did not receive any public comments on the proposed rule. The Chief Counsel for Advocacy of the Small Business Administration (SBA) did not file any comments on the IRFA or the proposed rule. The description of this action, its purpose, and its legal basis are described in the preamble to the proposed rule and are not repeated here. A Final Regulatory Flexibility Analysis (FRFA) was prepared and incorporates the IRFA. There were no public comments received on the IRFA. NMFS also prepared a RIR for this action. A copy of the RIR/FRFA is available from NMFS (see ADDRESSES ). A summary of the FRFA, per the requirements of 5 U.S.C. 604 follows.

Under the Regulatory Flexibility Act (RFA), the term “small entities” includes small businesses, small organizations, and small governmental jurisdictions. The Small Business Administration has established size criteria for entities involved in the fishing industry that qualify as small businesses. A business involved in fish harvesting is a small business if it is independently owned and operated and not dominant in its field of operation (including its affiliates) and if it has combined annual receipts, not in excess of $11 million for all its affiliated operations worldwide (see 80 FR 81194, December 29, 2015). A wholesale business servicing the fishing industry is a small business if it employs 100 or fewer persons on a full time, part time, temporary, or other basis, at all its affiliated operations worldwide. A small organization is any nonprofit enterprise that is independently owned and operated and is not dominant in its field. A seafood processor is a small business if it is independently owned and operated, not dominant in its field of operation, and employs 750 or fewer persons on a full time, part time, temporary, or other basis, at all its affiliated operations worldwide (See North American Industry Classification System (NAICS) code 311710 at 13 CFR 121.201). For purposes of rulemaking, NMFS is also applying the seafood processor standard to catcher processors because whiting C/Ps earn the majority of the revenue from processed seafood product.

No public comments were received on the proposed rule.

This final rule announces the adjusted coastwide TAC and U.S. TAC and allocates Pacific whiting to the following sectors/programs: Tribal, Shorebased IFQ Program Trawl Fishery, MS Coop Program Whiting At-sea Trawl Fishery, and C/P Coop Program Whiting At-sea Trawl Fishery. The amount of Pacific whiting allocated to these sectors is based on the adjusted U.S. TAC.

We expect one tribal entity to fish for Pacific whiting in 2023. Tribes are not considered small entities for the purposes of RFA. Impacts to tribes are nevertheless considered in this analysis.

As of January 2023, the Shorebased IFQ Program is composed of 164 Quota Share permits/accounts (134 of which were allocated whiting quota pounds), and 35 first receivers, one of which is designated as whiting-only receivers and 11 that may receive both whiting and non-whiting.

These regulations also directly affect participants in the MS Co-op Program, a general term to describe the limited access program that applies to eligible harvesters and processors in the MS sector of the Pacific whiting at-sea trawl fishery. This program consists of six MS processor permits, and a catcher vessel fleet currently composed of a single co-op, with 34 Mothership/Catcher Vessel (MS/CV) endorsed permits (with three permits each having two catch history assignments).

These regulations also directly affect the C/P Co-op Program, composed of 10 C/P endorsed permits owned by three companies that have formed a single coop. These co-ops are considered large entities from several perspectives; they have participants that are large entities, and have in total more than 750 employees worldwide including affiliates.

Although there are three non-tribal sectors, many companies participate in two sectors and some participate in all three sectors. As part of the permit application processes for the non-tribal fisheries, based on a review of the Small Business Administration size criteria, permit applicants are asked if they considered themselves a “small” business, and they are asked to provide detailed ownership information. Data on employment worldwide, including affiliates, are not available for these companies, which generally operate in Alaska as well as the West Coast and may have operations in other countries as well. NMFS has limited entry permit holders self-report size status. For 2023, all 10 C/P permits reported they are not small businesses, as did 8 mothership catcher vessels. There is substantial, but not complete overlap between permit ownership and vessel ownership so there may be a small number of additional small entity vessel owners who will be impacted by this rule. After accounting for cross participation, multiple Quota Share account holders, and affiliation through ownership, NMFS estimates that there are 103 non-tribal entities directly affected by these regulations, 89 of which are considered “small” businesses.

This rule will allocate Pacific whiting between tribal and non-tribal harvesters (a mixture of small and large businesses). Tribal fisheries consist of a mixture of fishing activities that are similar to the activities that non-tribal fisheries undertake. Tribal harvests may be delivered to both shoreside plants and motherships for processing. These processing facilities also process fish harvested by non-tribal fisheries. The effect of the tribal allocation on non-tribal fisheries will depend on the level of tribal harvests relative to their allocation and the reapportionment process. If the tribes do not harvest their entire allocation, there are opportunities during the year to reapportion unharvested tribal amounts to the non-tribal fleets. For example, in 2022 NMFS reapportioned 40,000 mt of the original 70,463 mt tribal allocation. This reapportionment was based on conversations with the tribes and the best information available at the time, which indicated that this amount would not limit tribal harvest opportunities for the remainder of the year. The reapportioning process allows unharvested tribal allocations of Pacific whiting to be fished by the non-tribal fleets, benefitting both large and small entities. The revised Pacific whiting allocations for 2022 following the reapportionment were: Tribal 30,463 mt, C/P Co-op 126,287 mt; MS Co-op 89,144 mt; and Shorebased IFQ Program 156,002 mt.

The prices for Pacific whiting are largely determined by the world market because most of the Pacific whiting harvested in the United States is exported. The U.S. Pacific whiting TAC is highly variable, as have subsequent harvests and ex-vessel revenues. For the years 2016 to 2020, the total Pacific whiting fishery (tribal and non-tribal) averaged harvests of approximately 303,782 mt annually. The 2022 U.S. non-tribal fishery had a Pacific whiting catch of approximately 291,337 mt, and the tribal fishery landed less than 1,100 mt.

Impacts to the U.S. non-tribal fishery are measured with an estimate of ex-vessel revenue. The adjusted coastwide TAC of 625,000 mt would result in an adjusted U.S. TAC of 461,750 mt and, after deduction of the tribal allocation and the incidental catch set-aside, a U.S. non-tribal harvest guideline of 380,194 mt. Using the 2022 weighted-average non-tribal price per metric ton ( e.g., $233.5 per metric ton), the TAC is estimated to result in an ex-vessel revenue of $88.8 million for the U.S. non-tribal fishing fleet.

Impacts to tribal catcher vessels who elect to participate in the tribal fishery are measured with an estimate of ex-vessel revenue. In lieu of more complete information on tribal deliveries, total ex-vessel revenue is estimated with the 2022 average ex-vessel price of Pacific whiting, which was $233.50 per mt. At that price, the 2023 tribal allocation of 80,806.25 mt would have an ex-vessel value of $18.87 million.

For the allocations to the non-tribal commercial sectors the Pacific whiting tribal allocation, and the set-aside for research and incidental mortality NMFS considered two alternatives: “No Action” and the “Proposed Action.” No other alternatives were considered by the Council at their November 2022 meeting.

Under the no action alternative, NMFS would not implement allocations to the non-tribal sectors based on the JMC recommended U.S. TAC, which would not fulfill NMFS' responsibility to manage the U.S. fishery. This is contrary to the Whiting Act and Agreement, which requires sustainable management of the Pacific whiting resource, therefore this alternative received no further consideration.

Under the no action alternative, NMFS would not implement the set-aside amount of 750 mt recommended by the Council. Not implementing a set-aside of the U.S. whiting TAC would mean incidental mortality of the fish in research activities and non-groundfish fisheries would not be accommodated. This would be inconsistent with the Council's recommendation, the Pacific Groundfish Fishery Management Plan, the regulations setting the framework governing the groundfish fishery, and NMFS' responsibility to manage the fishery. Therefore the no action alternative received no further consideration.

NMFS did not consider a broader range of alternatives to the tribal allocation because the tribal allocation is a percentage of the U.S. TAC and is based primarily on the requests of the tribes. These requests reflect the level of participation in the fishery that will allow them to exercise their treaty right to fish for Pacific whiting. Under the Action alternative, NMFS will set the tribal allocation percentage at 17.5 percent, as requested by the Tribes. This would yield a tribal allocation of 80,806 mt for 2023. Consideration of a percentage lower than the tribal request of 17.5 percent is not appropriate in this instance. As a matter of policy, NMFS has historically supported the harvest levels requested by the Tribes. Based on the information available to NMFS, the tribal request is within their tribal treaty rights. A higher percentage would arguably also be within the scope of the treaty right. However, a higher percentage would unnecessarily limit the non-tribal fishery.

Under the no action alternative, NMFS would not make an allocation to the tribal sector. This alternative was considered, but the regulatory framework provides for a tribal allocation on an annual basis only. Therefore, the no action alternative would result in no allocation of Pacific whiting to the tribal sector in 2023, which would be inconsistent with NMFS' responsibility to manage the fishery consistent with the Tribes' treaty rights. Given that there is a tribal request for allocation in 2023, this alternative received no further consideration.

NMFS determined this final rule would not adversely affect small entities. The reapportioning process allows unharvested tribal allocations of Pacific whiting, fished by small entities, to be fished by the non-tribal fleets, benefitting both large and small entities.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. A small entity compliance guide will be sent to stakeholders, and copies of the final rule and guides ( i.e., information bulletins) are available from NMFS at the following website: https://www.fisheries.noaa.gov/species/pacific-whiting#management.

With this final rule, NMFS, acting on behalf of the Secretary, determined that the FMP is implemented in a manner consistent with treaty rights of four Treaty Tribes to fish in their “usual and accustomed grounds and stations” in common with non-tribal citizens. United States v. Washington, 384 F. Supp. 313 (W.D. Wash. 1974).

This final rule contains no information collection requirements under the Paperwork Reduction Act of 1995.

For the reasons set out in the preamble, NMFS amends 50 CFR part 660 as follows:

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

The 2023 Pacific cod total allowable catch (TAC) apportioned to vessels using jig gear in the Central Regulatory Area of the GOA is 111 metric tons (mt) as established by the final 2023 and 2024 harvest specifications for groundfish in the GOA (88 FR 13238, March 2, 2023).

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

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

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion, and would delay prohibiting the retention of Pacific cod by vessels using jig gear in the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of May 24, 2023.

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