The purposes of the proposed action are watershed protection and flood damage reduction. Watershed protection goals consist of reducing downstream nutrient loads, particularly phosphorus, and increasing quantity and quality of critical fish and wildlife habitats. The Watershed Project Plan is authorized under the authority of the Watershed Protection (XE “Watershed Protection) and Flood Prevention Act of 1954 (Pub. L. 83-566) as amended and the Regional Conservation Partnership Program Project (16 U.S.C. Chapter 58, Subchapter VIII). This action is needed because the North Branch Park River Watershed incurs $1,733,000 in average annual flood damage as a result of 4,485 acres of cropland inundation and damage to roads, buildings, and other property. The 100-year flood inundates 136 structures, including the community of Crystal, ND. The watershed annually contributes 36,412 pounds of phosphorus and 197,533 pounds of nitrogen to the Red River. for which United States agreed to nutrient objectives at the international border have not been achieved. Historic loss of wetland and upland habitat within the Red River Basin also threatens multiple species.

NRCS will provide technical and financial assistance for the proposed project through the NRCS Watershed Protection and Flood Prevention Program. The EIS is expected to evaluate 2 alternatives: one action alternative or no action alternative. The alternatives we intend to carry forward to final analysis are:

Alternative 1 — No Action: No federal action would be taken in the North Branch Park River Watershed and implementation of significant flood damage reduction or watershed protection projects is not expected to occur. The frequency and magnitude of flood damages in the watershed would remain at the current level, with average crop losses of $876,300 annually due to flooding. Flood damage to a total of 136 structures, including homes, schools, and businesses in the community of Crystal, ND, will continue to generate average losses of $770,800 annually. Road maintenance associated with overtopping during floods will continue to generate average costs of $79,500 annually. The watershed will continue to contribute 36,412 pounds of phosphorus and 197,533 pounds of nitrogen to the Park River as well as the Red River and Lake Winnipeg. Wetlands and wildlife habitat will remain unchanged, barring a significant change in federal conservation programs.

Alternative 2 — Cart Creek Site 1: The preliminary proposed alternative under consideration at Cart Creek Site 1 is a multi-purpose, off-channel, dry dam (XE “Preferred Alternative”) with a drainage area of 33.8 square miles, embankment length of 2.6 miles, maximum height of 17.3 feet, and average height of 9.7 feet. The dam would provide 2,593 acre-feet of temporary flood storage at the auxiliary spillway crest elevation and inundate 466-acres for a duration of less than a week during flood events. A diversion weir would be constructed in Cart Creek and existing road ditches would be enlarged to route flows above a 2-year flood flow to the dam from Cart Creek. Surface water runoff and existing road ditches south of Cart Creek and west of the dam would be re-routed into the dry dam site via construction of new inlet structures and culverts designed to recreate natural sheet flow conditions. (XE “Flood Prevention”) Within the temporary flood pool, 134 acres of shallow retention cells would be constructed and managed via water control and biomass harvest for removal of incoming nutrient loads. Water would be held in those cells via closed control structures from spring through early fall, to allow growing vegetation to uptake dissolved phosphorus. Water would be drained through control structures and via a pumped subsurface drainage system to allow vegetation to be cut, baled, and removed from the site prior to the first frost in 2 out of each 3 years. The alternative would also result in restoration of 284 acres of wetlands, enhancement of 16 acres of existing wetlands, and enhancement of 52 acres of uplands which would be managed for high quality wildlife habitat via grazing as needed.

The two alternatives described above will be evaluated against each other in the EIS.

An NRCS evaluation of this federally assisted action indicates that the proposed alternative may have a significant local, regional, national, or international impact on the environment. Hydrologic impacts include peak flow reductions of 64 percent and 66 percent of the 10- and 100-year recurrence interval flood events immediately downstream of the retention site, and 20 percent and 28 percent of the 10- and 100-year recurrence interval flood events at the downstream community of Crystal, ND. Immediately downstream of the retention site, average annual loads of total phosphorus, total nitrogen, and total suspended solids are reduced by 60 percent, 66 percent, and 38 percent respectively. The proposed alternative would result in a total loss of 5.7 acres of wetlands through fill placement and excavation, which will be mitigated for via onsite wetland restoration. The project generates a net restoration of 284 acres of wetlands (total of 289.7 acres) and enhances 16 acres of existing wetlands as a result of restored hydrology and vegetative communities, enhancement of 18 acres of existing wetlands that are currently cropped, and enhancement of 52 acres upland wildlife habitat for the benefit of migratory birds and other wildlife species. Short term negative impacts during construction are anticipated to be local only, and may occur in relation to soils, vegetation, noise, and traffic.

The following permits and other authorizations are anticipated to be required:

• CWA Section 404 permit. Implementation of the proposed federal action would require a Clean Water Act (CWA) Section 404 permit from the U.S. Army Corps of Engineers, which is a cooperating federal agency on the planning effort. Consultation is ongoing and no significant challenges are anticipated given the overall environmental benefits of the project.

• CWA Section 401 permit. The project would also require water quality certification under Section 401 of the CWA and permitting under Section 402 of the CWA (National Pollutant Discharge Elimination Permit), both of which would be issued by the ND Department of Environmental Quality, a cooperating state agency on the planning effort. Consultation is ongoing and no significant challenges are anticipated given the overall environmental benefits of the project and the fact this is an off-channel retention structure.

• Permit to Construct or Modify a Dam. The project will require authorization from the North Dakota Department of Water Resources (ND DWR) for construction of a dam. ND DWR is a cooperating state agency on the plan and is assisting in funding for the project.

• Water Appropriation Permit. The project may require a conditional water use permit from ND DWR for construction of a dam. ND DWR is a cooperating state agency on the plan and is assisting in funding for the project.

• Floodplain Permit. The project will require a floodplain development permit from Pembina County. Pembina County is a cooperating local agency on the project.

• NHPA Section 106 Consultation. Consultation with Tribal Nations and interested parties is being conducted as required by the National Historic Preservation Act of 1966.

A draft (DEIS) will be prepared and circulated for review and comment by agencies and the public for at least 45 days per 40 CFR 1503.1, 1502.2, 1506.11, 1502.17, and 7 CFR 650.13. The DEIS is anticipated to be published in the Federal Register approximately 6 months after publication of this NOI. A final EIS is anticipated to be published within 6 months of completion of the public comment period for the DEIS. NRCS will then decide whether to implement one of the alternatives as evaluated in the EIS. A Record of Decision will be completed after the required 30-day waiting period and will be publicly available. The responsible federal official for the NRCS is Mary Podoll, North Dakota State Conservationist.

Public scoping meetings will be held at the Cart Creek Site 1 Project to further develop the scope of the DEIS. A preliminary scoping meeting was held on February 17, 2016, in Mountain, ND. An additional scoping meeting will be held after the NOI is published. Comments received for both meetings, including names and addresses of those who comment, will be part of the public record. The date, time, and location for the second meeting will be provided on the ND NRCS website, the Pembina Water Resource District website, and published in the Cavalier Chronicle.

NRCS will coordinate the scoping process as provided in 36 CFR 800.2(d)(3) and 800.8 (54 U.S.C. 306108) to help fulfill the National Historic Preservation Act (NHPA), as amended, review process.

NRCS invites agencies, tribes, and individuals who have special expertise, legal jurisdiction, or interest in the Cart Creek Site 1 Project to provide comments concerning the scope of the analysis and identification of potential alternatives, information, and analyses relevant to the Proposed Action.

This document is published in line with the National Environmental Policy Act (NEPA) regulations regarding publication of a notice of intent to issue an environmental impact statement (40 CFR 1501.9(d)). The EIS will be prepared to evaluate potential environmental impacts as required by section 102(2)(C) of the National Environmental Policy Act of 1969 (NEPA, the Council on Environmental Quality regulations (40 CFR parts 1500-1508) and NRCS regulations that implement NEPA in 7 CFR part 650. Watershed planning is authorized under the Watershed Protection and Flood Prevention Act of 1954, as amended, (Pub. L. 83-566) and the Flood Control Act of 1944 (Pub. L. 78-534).

The titles and numbers of the Federal Domestic Assistance Programs found in the Catalog of Federal Domestic Assistance to which Notice of Funding Availability applies is 10.904 Watershed Protection and Flood Prevention.

Executive Order 12372, “Intergovernmental Review of Federal Programs,” requires consultation with State and local officials that would be directly affected by proposed Federal financial assistance. The objectives of the Executive order are to foster an intergovernmental partnership and a strengthened federalism, by relying on State and local processes for State and local government coordination and review of proposed Federal financial assistance and direct Federal development. This program is subject to the provisions of Executive Order 12372, which requires intergovernmental consultation with State and local officials.

In accordance with Federal civil rights law and USDA civil rights regulations and policies, USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family or parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

Persons with disabilities who require alternative means of communication for program information (for example, braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA TARGET Center at (202) 720-2600 (voice) or dial 711 for Telecommunications Relay Service (both voice and text telephone users can initiate this call from any telephone). Additionally, program information may be made available in languages other than English.

To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at https://www.usda.gov/oascr/how-to-file-program-discrimination-complaint and at any USDA office or write a letter addressed to USDA and provide in the letter all the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410 or email: OAC@usda.gov. USDA is an equal opportunity provider, employer, and lender.

The watershed project would be implemented as flood protection, as authorized under sections 3 and 4 of Public Law 83-566. The primary purpose for this watershed plan is to provide reliable and long-term flood prevention and damage reduction to the RD 1500 service area and improve public safety and emergency access. Watershed planning was authorized under Public Law 83-566, the Watershed Protection and Flood Prevention Act of 1954, as amended, and Public Law 78-534, the Flood Control Act of 1944.

RD 1500, one of the largest reclamation districts in California, was created by special act of the State Legislature in 1913. It provides drainage and flood control to an area of approximately 67,850 acres within its service area, including protecting the community of Robbins and surrounding rural residential property from flood damage, protecting over 60,000 acres of rural farmland from flooding, and providing flood protection of SR 113 and other local emergency response roadways. The project will address issues at the Karnak Drainage Facility which was originally built in 1914 with two additional facilities added in 1929 and 1952. These facilities have continued to protect the RD1500 for over 100 years. However, they are all past their useful service life. While RD1500 has continued to maintain these facilities, it has become increasingly difficult to obtain parts and keep the facilities functional during storm events.

The Karnak Drainage Facilities provided flood protection for 70 Year-Level storm events from January to March of 2017, which were the second highest precipitation events in the last 144 years record in the northern California area. Uncharacteristically of the facilities, all pumping stations were operational at the time. The Karnak Drainage Facility was able to provide flood reduction to approximately 31,200 acres of prime farmland within the Sutter Basin and the community of Robbins would have been under 5 to 6 feet of water, completely cutting off access to SR 113, which at the time was being use by residence of Oroville, California as an evacuation route from the Orville Dam crisis of February 2017.

To meet the purpose of continuing flood protection for the Sutter Basin, modernization of the existing Karnak Facilities will be necessary. A Preliminary Investigative Report (PIR), completed by RD1500 in 2021, investigated and studied possible solutions to address flood protection in the Sutter Basin. As a result of the new information obtained during an EA process, the level of analysis this watershed project needs is more extensive than anticipated during scoping in 2021. Estimated Federal funds required for the construction of the proposed action may exceed $25 million and the proposed action will therefore require congressional approval per the 2018 Agriculture Appropriations Act amended funding threshold. In accordance with 7 CFR 650.7(a)(2), an EIS is required for projects requiring congressional approval.

The objective of the EIS is to formulate and evaluate alternatives for flood prevention in the RD 1500 service area. Three Action Alternatives are expected to be evaluated in the EIS, given their anticipated viability of meeting the purpose and need of the Watershed Project.

— Proposed Action Alternative—Modernization. This alternative would evaluate rehabilitating the existing antiquated Karnak Facility by modernizing and repairing the facilities. The proposed action is to demolish two facilities on the west side of the levee and build a new facility. The district will install temporary cofferdams on the west side to remove these facilities and gain access to the existing outlets. The existing outlets will be reused to prevent need of disturbing the levee. A new facility will be built on the west side to replace the 1929 and 1952 facilities. The 1914 facility will remain and be rehabilitated with new systems/pumps. The existing outlet structures will be reused and relined at all three existing discharge culvert locations. This significantly reduces the environmental impacts from this project. Temporary cofferdams may need to be installed on the east side of the levee next to the East Canal depending on water level. This may be necessary to safely finish the installation of the liners and a fish barrier. No equipment will be driven into the East Canal and no permanent impacts will take place to habitat on the East Canal. Fill will be about 1,500 cubic yards on the west side for the new facility, but it will not change the existing footprint in the watercourse. This alternative will provide continued flood protection within the Sutter Basin and continually allow access to SR 113 for public emergencies.

—Flood Plain Restoration Alternative—Alternative 2. This alternative, a nonstructural alternative, would include purchasing land to restore the floodplain. This would include removing the town of Robbins and removing approximately 31,200 acres of prime farmland within the Sutter Basin. This alternative would not allow the continual use of SR 113 during emergencies.

—No Action. Taking no action alternative would consist of Karnak Drainage Facility continuing its current operations while the facility continually degrades until it becomes impossible to keep the facility operational during active storm events. The No Action Alternative is not expected to meet the project's purpose and need.

Initial cost estimates of the proposed actions have determined that the Federal contribution to construction will exceed $25 million, requiring congressional approval. Per 7 CFR 650.7, an EIS is required when projects require congressional action. The NRCS California State Conservationist, has determined that the preparation of an EIS is required for this watershed project. This EIS will be prepared as required by section 102(2)(C) of the National Environmental Policy Act of 1969 (NEPA); the Council on Environmental Quality Regulations (40 CFR parts 1500-1508); and NRCS regulations that implement NEPA in 7 CFR part 650.

Resource concerns for scoping were identified and categorized as relevant or not relevant to the proposed Project action. RD 1500 and NRCS evaluated the current Karnak Drainage Facility infrastructure along with relevant resource concerns for each proposed solution. Environmental resources in the project area consist of the natural and man-made environment. Resource concerns to be identified and addressed in the Watershed Plan-EIS include Cultural and Historic Resources; Land Resources/Prime Farmland; Geology and Soils; Public Safety; Socioeconomics/Environmental Justice; Water Resources; Vegetation/Invasive and Non-native Plant Species; Wetlands and Riparian Areas; Fish and Wildlife/Fish Habitat; and Special Status Species/Migratory Bird Treaty Act Species.

The following permits and authorizations are anticipated to be required:

A Draft EIS (DEIS) will be prepared and circulated for review and comment by agencies, Tribes, consulting parties, and the public for 45 days per 40 CFR 1503.1, 1502.20, 1506.11, and 1502.17, and 7 CFR 650.13. The DEIS is anticipated to be published in the Federal Register in 2023, approximately 6 months after publication of this NOI. A Final EIS is anticipated to be published within 6 months of completion of the public comment period for the DEIS. NRCS invites agencies and individuals who have special expertise, legal jurisdiction, or interest in the McGriff lakes—Sutter Basin Watershed to participate and identify potential alternatives. The responsible Federal official and decision maker for the NRCS is the California NRCS State Conservationist.

A public scoping meeting was held on March 30, 2021. Comments received, including the names and addresses of those who comment, will be part of the public record. Scoping meeting presentation materials are available on the project website: https://sutterbasinwater.com/flood-control-flood-safety-rehabilitation-project/. The date, time, and location for a second meeting will be announced on the project website.

Federal, State, Tribal, local agencies and representatives, and the public were invited to take part in this watershed plan scoping period. One public scoping meeting sought input on issues of economic, environmental, cultural, and social importance in the watershed. RD 1500 and NRCS organized the public scoping meeting to provide an opportunity to review and evaluate the Project alternatives, express concern or support, and gain further information regarding the Project. To determine the most viable alternatives to carry forward to the EIS, RD 1500 used input obtained during public scoping discussions to focus on relevant resource concerns and issues and eliminated those that were not relevant from further detailed study.

NRCS invites agencies, Tribes, consulting parties, and individuals who have special expertise, legal jurisdiction, or interest in the Watershed Project to provide comments concerning the scope of the analysis and identification of potential alternatives, information, and analyses relevant to the Proposed Action.

NRCS will coordinate the scoping process to correspond with any required NHPA processes, as allowed in 36 CFR 800.2(d)(3) and 800.8 (54 U.S.C. 306108). The information about historic and cultural resources within the area potentially affected by the proposed project will assist NRCS in identifying and evaluating impacts to such resources in the context of both NEPA and NHPA.

NRCS will consult with Native American tribes on a government-to-government basis in accordance with 36 CFR 800.2 and 800.3, Executive Order 13175, and other policies. Tribal concerns, including impacts on Indian trust assets and potential impacts to cultural resources and historic properties, will be given due consideration.

This document is published pursuant to the NEPA regulations regarding publication of a notice of intent to issue an environmental impact statement (40 CFR 1501.9(d)). Watershed planning is authorized under the Watershed Protection and Flood Prevention Act of 1954, as amended, (Pub. L. 83-566) and the Flood Control Act of 1944 (Pub. L. 78-534).

The title and number of the Federal assistance program as found in the Assistance Listing (formerly referred to as the Catalog of Federal Domestic Assistance) to which this document applies is 10.904 Watershed Protection and Flood Prevention.

Executive Order 12372, “Intergovernmental Review of Federal Programs,” requires consultation with State and local officials that would be directly affected by proposed Federal financial assistance. The objectives of the Executive order are to foster an intergovernmental partnership and a strengthened federalism, by relying on State and local processes for State and local government coordination and review of proposed Federal financial assistance and direct Federal development. This program is subject to the provisions of Executive Order 12372, which requires intergovernmental consultation with State and local officials.

In accordance with Federal civil rights law and USDA civil rights regulations and policies, USDA, its agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family or parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

Persons with disabilities who require alternative means of communication for program information (for example, braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA TARGET Center at (202) 720-2600 (voice and TTY). Additionally, program information may be made available in languages other than English.

To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at: https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint and at any USDA office or write a letter addressed to USDA and provide in the letter all the information requested in the form. To request a copy of the complaint form, call (866) 632 9992. Submit your completed form or letter to USDA by mail to: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410 or email: OAC@usda.gov.

USDA is an equal opportunity provider, employer, and lender.

Pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. app., notice is hereby given that the IoT Advisory Board will hold an open meeting Wednesday, January 18, 2023, and Thursday, January 19, 2023, from 11:00 a.m. until 5:00 p.m., Eastern Time. All sessions will be open to the public. The IoT Advisory Board is authorized by section 9204(b)(5) of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (Pub. L. 116-283), and advises the IoT Federal Working Group convened by the Secretary by providing recommendations on overcoming barriers to adoption of and challenges to achieving the benefits from IoT technology. Details regarding the IoT Advisory Board's activities are available at https://www.nist.gov/itl/applied-cybersecurity/nist-cybersecurity-iot-program/internet-things-advisory-board.

The agenda is expected to include the following items:

Note that agenda items may change without notice. The final agenda will be posted on the IoT Advisory Board event page at: https://www.nist.gov/itl/applied-cybersecurity/nist-cybersecurity-iot-program/internet-things-advisory-board.

Public Participation: Written comments from the public are invited and may be submitted electronically by email to Barbara Cuthill at the contact information indicated in the FOR FURTHER INFORMATION CONTACT section of this notice by 5 p.m. on Thursday, January 12, 2023.

The IoT Advisory Board agenda will include a period, not to exceed sixty minutes, for submitted comments from the public between 3:00 p.m. and 4:00 p.m. on Thursday, January 19, 2023. Submitted comments from the public will be selected on a first-come, first-served basis and limited to five minutes per person.

Members of the public who wish to expand upon their submitted statements, those who had wished to submit a comment but could not be accommodated on the agenda, and those who were unable to attend the meeting via webinar are invited to submit written statements. In addition, written statements are invited and may be submitted to the IoT Advisory Board at any time. All written statements should be directed to the IoT Advisory Board Secretariat, Information Technology Laboratory by email to: Barbara.Cuthill@nist.gov.

Admittance Instructions: Participants planning to attend via webinar, must register via the instructions found on the IoT Advisory Board's event page at: https://www.nist.gov/itl/applied-cybersecurity/nist-cybersecurity-iot-program/internet-things-advisory-board.

Pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. App., notice is hereby given that the NIST Safety Commission will meet on January 4, 2023, from 8:30 a.m. to 5:00 p.m. Eastern Time and January 5, 2023, from 8:30 a.m. to 5:00 p.m. Eastern Time. The meeting will be open to the public. Members of the Commission are appointed by the Director of NIST. The Commission is composed of not more than seven members who are qualified to provide advice to the NIST Director on matters relating to safety policies; safety management system, practices, and performance; and safety culture. The primary purpose of this meeting is for the Commission to begin its assessment of the state of NIST's safety culture and how effectively the existing safety protocols and policies have been implemented across NIST. The agenda may change to accommodate Commission business. The final agenda will be posted on the NIST website at https://www.nist.gov/document/nist-safety-commission-jan-2023-agenda.

Individuals and representatives of organizations who would like to offer comments and suggestions related to the Commission's business are invited to request a place on the agenda. Approximately 15 minutes will be reserved for public comments and speaking times will be assigned on a first-come, first-serve basis. The amount of time per speaker will be determined by the number of requests received but is likely to be about three minutes each. Questions from the public will not be considered during this period. Requests must be submitted by email to Corrine Lloyd at corrine.lloyd@nist.gov and must be received by 4:00 p.m. Eastern Time, December 28, 2022 to be considered. Speakers who wish to expand upon their oral statements, those who had wished to speak but could not be accommodated on the agenda, and those who were unable to participate are invited to submit written statements by email to corrine.lloyd@nist.gov.

All NIST staff and public participants will be attending via webinar and must contact Corrine Lloyd at corrine.lloyd@nist.gov by 4:00 p.m. Eastern Time, December 28, 2022 for detailed instructions on how to join the webinar.

Authority: 15 U.S.C. 1512 as amended, and the Federal Advisory Committee Act, as amended, 5 U.S.C. App.

The Council will host a presentation from NOAA entitled “NOAA's Recent Deep-Sea Coral Related Research, Exploration, and Mapping in the U.S. South Atlantic”. This presentation will share highlights of research funded by NOAA's Deep-Sea Coral Research & Technology Program between 2016 and 2019, and exploration and mapping conducted by NOAA Ocean Exploration in the South Atlantic region. Highlights include a summary of discoveries from nine expeditions to collect seafloor imagery, including the largest known deep-sea coral reef province in the world, and major mapping advances on the Blake Plateau and surrounding areas. A question-and-answer session will follow the presentation. Members of the public will have the opportunity to participate in the discussion. The presentation is for informational purposes only and no management actions will be taken.

The meeting is physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see ADDRESSES ) five days prior to the meeting.

Authority: 16 U.S.C. 1801 et seq.

The Shrimp AP meeting is open to the public and will be available via webinar as it occurs. Registration is required. Webinar registration information and other meeting materials will be posted to the Council's website at: https://safmc.net/advisory-council-meetings/ as it becomes available.

The AP will receive an overview of the Proposed Rule for the Restoration Blueprint for the Florida Key National Marine Sanctuary. The AP will develop recommendations for consideration by the Council.

The meeting is physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see ADDRESSES ) 5 days prior to the meeting.

Authority: 16 U.S.C. 1801 et seq.

The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a multi-step process including: (1) Data Workshop; (2) Assessment Process utilizing webinars; and (3) Review Workshop. The product of the Data Workshop is a data report that compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Assessment Process is a stock assessment report that describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a Summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, HMS Management Division, and Southeast Fisheries Science Center. Participants include data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and NGO's; International experts; and staff of Councils, Commissions, and state and federal agencies.

The items of discussion in the webinar are as follows:

Participants will discuss data analysis and report writing conducted since the SEDAR Procedural Workshop 8.

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Council office (see ADDRESSES ) at least 10 business days prior to each workshop.

The meeting will begin with Introductions and Adoption of Agenda, Approval of Verbatim Minutes and Meeting Summary from the September 21-23, 2022, meeting, and a review of the Scope of Work. The Committees will select an SSC Representative for the January 30-February 2, 2023, Gulf Council Meeting. Following, the Committees will review presentations and a stock assessment report for SEDAR 75: Gulf of Mexico Gray Snapper, including other background materials for SSC discussion. The Committees will hold a discussion on Acceptable Biological Catch Control Rule Modifications, receive presentations, and review background materials. Public comment will be heard at the end of the day.

The Committees will continue review and discuss any topics from the previous day if time is needed. The Committees will review and evaluate updated Red Snapper Calibration Ratios for Gulf state surveys to MRIP, along with presentations and background materials; and will receive public comment at the end of the day, if any.

The Committees will review and discuss the presentation and other background materials for Gulf Red Grouper Interim Analysis and Projections. If further discussions on the stock assessment report for SEDAR 75: Gulf of Mexico Gray Snapper are needed, they will be held prior to the Committees receiving public comment before addressing any items under Other Business.

The meeting will also be broadcast via webinar. You may register for the webinar by visiting www.gulfcouncil.org and clicking on the SSC meeting on the calendar.

The Agenda is subject to change, and the latest version along with other meeting materials will be posted on www.gulfcouncil.org as they become available.

Although other non-emergency issues not on the agenda may come before the Scientific and Statistical Committees for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the Scientific and Statistical Committee will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take-action to address the emergency.

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to Kathy Pereira, (813) 348-1630, at least 5 days prior to the meeting date.

Authority: 16 U.S.C. 1801 et seq.

On October 6, 2022, CPSC published a notice in the Federal Register to announce the agency's intention to seek extension of approval of the collection of information. 87 FR 60660. The Commission received no comments. Accordingly, CPSC seeks renewal approval for the following collection of information:

Title: Third party conformity assessment bodies seeking acceptance of accreditation or continuing accreditation.

OMB Number: 3041-0143.

Type of Review: Renewal of collection.

Frequency of Response: On occasion.

Affected Public: Third party conformity assessment bodies seeking acceptance of accreditation or continuing accreditation.

Estimated Burden: The CPSC estimates the burden of the collection of information in the Consumer Product Conformity Assessment Body Registration Form (CPSC Form 223) is as follows:

These estimates are based on the following information:

• Based on applications received from FY 2013 to date, we estimate the number of third party conformity assessment bodies that would register each year for the next 3 years would be 26.

• Under 16 CFR part 1112, third party conformity assessment bodies are required to resubmit CPSC Form 223 every 2 years. As all third party conformity assessment bodies have not submitted their first CPSC Form 223s at the same time, only about half would be expected to resubmit a CPSC Form 223 in any 1 year. As of August 2022, 606 third party conformity assessment bodies have registered with CPSC. Therefore, approximately 303 of these firms would be expected to reregister with CPSC each year.

• Under 16 CFR part 1112, third party conformity assessment bodies are required to ensure that the information submitted on CPSC Form 223 is current and must submit a new CPSC Form 223 whenever the information changes. Based on current experience with third party conformity assessment bodies, we estimate that each year 2 third party conformity assessment bodies will make revisions to update their information. A change in information is a change that does not require review of laboratory accreditation documents, such as scope or test methods. Examples of revised information include changes in the website URL, name of the laboratory, and name of laboratory point of contact.

The total burden, therefore, is 329.5 hours, which we round up to 330 hours. We estimate that hourly compensation for the time required for recordkeeping is $36.59 per hour (U.S. Bureau of Labor Statistics, “Employer Costs for Employee Compensation (ECEC),” Table 4: Total compensation for private industry workers in sales and office occupations within goods-producing industries, June 2022, public news release url: www.bls.gov/news.release/archives/ecec_09202022.pdf ). The total cost burden to the respondents is approximately $12,075 ($36.59 × 330 hours = $12,074.70).

General Description of Collection: The Consumer Product Safety Improvement Act of 2008 (CPSIA) requires third party testing to be conducted by a third party conformity assessment body for any children's product that is subject to a children's product safety rule, before importing for consumption or warehousing or distributing in commerce. The CPSIA allows accreditation of third party conformity assessment bodies to be conducted either by the Commission, or by an independent accreditation organization designated by the Commission. In addition, the CPSIA requires that the Commission maintain on its website an up-to-date list of entities that have been accredited to assess conformity with children's product safety rules. With the exception of firewalled third party conformity assessment bodies, which must be approved by Commission order, as stated in 16 CFR 1112.13(b), the Commission has chosen to accept the accreditation of third party conformity assessment bodies that meet accreditation requirements of an independent accreditation organization. 16 CFR 1112.13(a).

To assess a third party conformity assessment body's qualifications for acceptance by CPSC, information related to location, accreditation, and ownership must be collected from third party conformity assessment bodies. The CPSC uses an online collection form, CPSC Form 223, to gather information from third party conformity assessment bodies voluntarily seeking acceptance by CPSC. The information collected relates to location, accreditation, and ownership. Commission staff uses this information to assess:

• A third party conformity assessment body's status as an independent third party conformity assessment body, a government-owned or government-controlled conformity assessment body, or a firewalled conformity assessment body;

• Qualifications for acceptance by CPSC to test for compliance to specified children's product safety rules; and

• Eligibility for acceptance on the CPSC website.

Part 1112 requires the collection of information in CPSC Form 223:

• Upon initial application by the third party conformity assessment body for acceptance by CPSC;

• Whenever there is a change to accreditation or ownership information; and

• At least every 2 years as part of a regular audit process.

This information collection was previously published as 60-Day Notice for Request for Generic Clearance for website Satisfaction Surveys at 87 FR 54203 (September 2, 2022).

Title: Generic Clearance for the Collection of Qualitative Feedback on website Satisfaction.

Abstract: The proposed information collection activity provides a means to garner qualitative website user and stakeholder feedback in an efficient, timely manner. By qualitative feedback CIGIE means information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into website user or stakeholder perceptions, experiences, and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training, or changes in operations might improve delivery of information. These collections will allow for ongoing, collaborative, and actionable communications between CIGIE and its stakeholders and the public. It will also allow feedback to contribute directly to the improvement of program management.

The solicitation of feedback will target areas such as: timeliness, appropriateness, accuracy of information, courtesy, efficiency of information delivery, and resolution of issues. Responses will be assessed to plan and inform efforts to improve or maintain the quality of CIGIE's websites. If this information is not collected, vital feedback from users and stakeholders of CIGIE's websites will be unavailable.

CIGIE will only submit a collection for approval under this generic clearance if it meets the following conditions:

The collections are voluntary;

The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government;

The collections are non-controversial and do not raise issues of concern to other Federal agencies;

Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future;

Personally identifiable information (PII) is collected only to the extent necessary and is not retained;

Information gathered will be used only internally for general service improvement and program management purposes and is not intended for release outside of the agency;

Information gathered will not be used for the purpose of substantially informing influential policy decisions; and

Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study.

Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: the target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study.

As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.

Current Action: Request for approval for a collection of information.

Type of Review: Initial approval.

Affected Public: Individuals, households, professionals, public/private sector.

Annual Reporting Burden: Estimated Number of Respondents: 20,000.

Responses per Respondent: 1.

Estimated Total Annual Responses: 20,000.

Estimated Average Hours per Response: 4 minutes.

Estimated Total Burden Hours: 666 hours.

Request for Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose, or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) (5 U.S.C., app.), the Government in the Sunshine Act (“the Sunshine Act”) (5 U.S.C. 552b), and title 41 Code of Federal Regulations (CFR), sections 102-3.140 and 102-3.150.

Due to circumstances beyond the control of the Designated Federal Officer, the Defense Policy Board was unable to provide public notification required by 41 CFR 102-3.150(a) concerning its December 13-14, 2022 meeting. Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement. Purpose of the Meeting: To obtain, review, and evaluate classified information related to the DPB's mission to advise on (a) issues central to strategic DoD planning; (b) policy implications of U.S. force structure and modernization on DoD's ability to execute U.S. defense strategy; (c) U.S. regional defense policies; and (d) other defense policy topics of special interest to the DoD, as determined by the Secretary of Defense, the Deputy Secretary of Defense, or the Under Secretary of Defense for Policy.

Agenda: On December 13, 2022 and December 14, 2022, the DPB will receive classified briefings and hold classified discussions on DoD's current role, processes, capabilities, and organizational constructs for planning and conducting information operations, military information support operations, and psychological operations in an era of expanding strategic competition including the application of emerging technology and the continuing evolution of social media platforms. The Secretary of Defense and the Undersecretary of Defense for Policy will address the DPB. The DPB will receive classified briefings on the following: (1) DoD Information Operations Doctrine and Posture from Christopher P. Maier, Assistant Secretary of Defense for Special Operations and Low-Intensity Conflict; (2) intelligence briefings on the current information environment; and allies and partners and the information environment, both with a question and answer session; (3) the evolution of information operations and psychological operations from LTG Braga, Commander, U.S. Army Special Operations Command and BG Gil Ferguson, Deputy Commanding General for Operations; (4) Combined Joint Task Force-Operation Inherent Resolve (CJTF-OIR) and Iraq's Counterterrorism Service from MG John Brennan, Director of Operations, J-3, United States Special Operations Command and former Commander CJTF-OIR (to be confirmed); (5) the United States Cyber Command approach to force development and information effects from Lt. Gen Timothy D. Haugh, Deputy Commander, U.S. Cyber Command (to be confirmed); (6) information operations for perception management case studies led by RDML Ronald A. Foy, Deputy Director for Global Operations, Joint Staff; and (7) participate in an information operations scenario-based discussion led by the Under Secretary of Defense for Policy and RDML Ronald A. Foy. The DPB will also deliberate and discuss their findings and recommendations of the previous DPB meeting in September 2022 and then brief the Secretary of Defense on the DPB's findings and recommendations from that meeting.

Meeting Accessibility: In accordance with section 10(d) of the FACA and 41 CFR 102-3.155, the DoD has determined that this meeting shall be closed to the public. The Under Secretary of Defense (Policy), in consultation with the DoD FACA Attorney, has determined in writing that this meeting be closed to the public because the discussions fall under the purview of Section 552b(c)(1) of the Sunshine Act and are so inextricably intertwined with unclassified material that they cannot reasonably be segregated into separate discussions without disclosing classified material.

Written Statements: In accordance with section 10(a)(3) of the FACA and 41 CFR 102-3.105(j) and 102-3.140(c), the public or interested organizations may submit written statements to the membership of the DPB at any time regarding its mission or in response to the stated agenda of a planned meeting. Written statements should be submitted to the DPB's DFO, which is listed in this notice or can be obtained from the GSA's FACA Database— http://www.facadatabase.gov/. Written statements that do not pertain to a scheduled meeting of the DPB may be submitted at any time. However, if individual comments pertain to a specific topic being discussed at a planned meeting, then these statements must be submitted no later than two business days prior to the meeting in question. The DFO will review all submitted written statements and provide copies to all members.

The Board's charter is being renewed pursuant to 10 U.S.C. 1114(a)(1), and in accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C., Appendix) and 41 CFR 102-3.50(a). The Board's charter and contact information for the Board's Designated Federal Officer (DFO) can be found at http://www.facadatabase.gov/.

The Board provides independent advice and recommendations on actuarial matters associated with the DoD Medicare-Eligible Retiree Health Care Fund (the Fund) and other related matters. Pursuant to 10 U.S.C. 1114(b), the Board reports annually to the Secretary of Defense and the Deputy Secretary of Defense on the actuarial status of the Fund and shall furnish its advice and opinion on matters referred to it by the Secretary of Defense. Pursuant to 10 U.S.C. 1114(c), the Board reviews valuations of the Fund under 10 U.S.C. 1115(c) and reports periodically, not less than once every four years to the President and Congress on the status of the Fund. The Board shall include in such reports recommendations for such changes as in the Board's judgment are necessary to protect the public interest and maintain the Fund on a sound actuarial basis.

The Board, pursuant to 10 U.S.C. 1114(a)(1) and (2), shall consist of three members who shall be appointed by the Secretary of Defense from among qualified professional actuaries who are members of the Society of Actuaries. Board members will serve for a term of 15-years, except that a Board member appointed to fill a vacancy occurring before the end of the term of which the predecessor was appointed shall serve only until the end of such term. A Board member may serve after the end of the term until a successor has taken office. Of the members of the Board, one each shall be appointed for terms ending five, ten, and 15 years respectively, after the date of appointment, as designated by the Secretary of Defense at the time of appointment.

Board members who are not full-time or permanent part-time Federal civilian officers or employees, or active-duty members of the Uniformed Services, shall be appointed as experts or consultants pursuant to 5 U.S.C. 3109 to serve as special government employee members and are entitled, pursuant to 10 U.S.C. 1114(a)(3), to receive pay at the daily equivalent of the annual rate of basic pay of the highest rate of basic pay under the General Schedule of subchapter 53 of title 5, for each day the member is engaged in the performance of duties vested in the Board. Board members who are full-time or permanent part-time Federal civilian officers or employees, or members of the uniformed Services, shall be appointed pursuant to 41 CFR 102-3.130(a) to serve as regular government employee members.

Each Board member is appointed to exercise their own judgment on behalf of the DoD, without representing any particular point of view, and to discuss and deliberate in a manner that is free from conflict of interest.

The public or interested organizations may submit written statements to the Board membership about the Board's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of the Board. All written statements shall be submitted to the DFO for the Board, and this individual will ensure that the written statements are provided to the membership for their consideration.

The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: International Computer and Information Literacy Study (ICILS 2023) Main Study Questionnaire Revision.

OMB Control Number: 1850-0929.

Type of Review: A revision of a currently approved ICR.

Respondents/Affected Public: Individuals and households.

Total Estimated Number of Annual Responses: 9,860.

Total Estimated Number of Annual Burden Hours: 5,055.

Abstract: The International Computer and Information Literacy Study (ICILS) is a computer-based international assessment of eighth-grade students' computer and information literacy (CIL) skills. ICILS was first administered internationally in 2013 in 21 education systems and again in 2018, when the United States participated for the first time. Our participation in this study has provided data on students' skills and experience using technology to investigate, create, and communicate, and provided a comparison of U.S. student performance and technology access and use with those of the international peers. The next administration of ICILS will be in 2023. The 2023 study will allow the U.S. to begin monitoring the progress of its students compared to that of other nations and to provide data on factors that may influence student computer and information literacy skills. The data collected through ICILS will provide valuable information with which to understand the nature and extent of the “digital divide” and has the potential to inform understanding of the relationship between technology skills and experience and student performance in other core subject areas. ICILS is conducted by the International Association for the Evaluation of Educational Achievement (IEA), an international collective of research organizations and government agencies that create the assessment framework, assessment, and background questionnaires. The IEA decides and agrees upon a common set of standards and procedures for collecting and reporting ICILS data, and defines the study timeline, all of which must be followed by all participating countries. As a result, ICILS is able to provide a reliable and comparable measure of student skills in participating countries. In the U.S., the National Center for Education Statistics (NCES) conducts this study and works with the IEA and RTI International to ensure proper implementation of the study and adoption of practices in adherence to the IEA's standards. Participation in ICILS will allow NCES to meet its mandate of acquiring and disseminating data on educational activities and student achievement in the United States compared with foreign nations [The Educational Sciences Reform Act of 2002 (ESRA 2002) 20 U.S.C. 9543]. The U.S. ICILS main study will be conducted from March through May 2023 and will involve a nationally-representative sample of at least 3,000 eighth-grade students from a minimum of 150 schools. Because ICILS is a collaborative effort among many parties, the United States must adhere to the international schedule set forth by the IEA, including the availability of final field test and main study plans as well as draft and final questionnaires. In order to meet the international data collection schedule and to align with recruitment for other NCES studies ( e.g., TIMSS), approval for the main study sampling, recruitment, and data collection activities was approved in April 2022 (OMB# 1850-0929 v9). A 30D public comment period accompanied a set of revisions to the study timeline, study portal, main study contact materials, and the addition of COVID-related items in the questionnaires; those revisions were approved in October 2022 (OMB# 1850-0929 v10). This request is for approval of (1) updated descriptions of data collection plans; (2) updated burden estimates related to main study questionnaire changes; and (3) changes to the final adapted main study questionnaires based on review by IEA. This request is accompanied by 30 days of public comment. Changes are described below and are included in the supporting documentation.

The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: RISE Award.

OMB Control Number: 1860-0510.

Type of Review: Extension without change of a currently approved ICR.

Respondents/Affected Public: Individuals or Households.

Total Estimated Number of Annual Responses: 600.

Total Estimated Number of Annual Burden Hours: 18,000.

Abstract: The purpose of the Recognizing Inspirational School Employees (RISE) Award is to recognize and promote the commitment and excellence exhibited by classified school employees who provide exemplary service to students in pre-kindergarten through high school and to inspire innovation and excellence among all classified school employees. A classified school employee is an employee of a state or any political subdivision of a state, or an employee of a nonprofit entity, who works in any grade from pre-kindergarten through high school in any of the following occupational specialties: paraprofessional, clerical and administrative services, transportation services, food and nutrition services, custodial and maintenance services, security services, health and student services, technical services, and skilled trades. The terms used have the meaning given the terms in section 8101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801). The U.S. Department of Education (Department) invites the governor of each state to nominate up to two classified school employees. The Secretary of Education will select a single classified school employee to receive the RISE Award for that school year by spring. The Department will communicate the selectee's story in order to inspire other innovative practices and excellence among classified school employees.

EPA is announcing its intent to cancel the registrations of three pesticide products containing the insecticide chlorpyrifos due to the revocation of all chlorpyrifos tolerances. Specifically, EPA intends to cancel each of the following pesticide products, which allow for use on food crops, listed in sequence by EPA registration number.

• EPA Reg. No. 93182-3 Chlorpyrifos Technical.

• EPA Reg. No. 93182-7 Pilot 4E Chlorpyrifos Agricultural Insecticide.

• EPA Reg. No. 93182-8 Pilot 15G Chlorpyrifos Agricultural Insecticide.

The following information is the address on record for Gharda, the registrant of the products listed in this unit and subject to this notice, and includes the company number which corresponds to the first part of the EPA registration number of the products:

• EPA Co. No. 93182—Gharda Chemicals International, Inc., 4932 Crockers Lake Blvd., Suite 818, Sarasota, Florida 34238.

In addition, this document summarizes EPA's legal authority for the proposed cancellation (see unit II.); the revocation of tolerances for residues of chlorpyrifos on food commodities (see unit III.); the Agency's rationale for issuance of this NOIC (see unit IV.); the timing of the proposed cancellations, EPA's existing stocks determination, and the potential scope of any final cancellation order (see unit V.); the results of the Agency's coordination with the U.S. Department of Agriculture (USDA) and the FIFRA Science Advisory Panel (SAP) (see unit VI.); and how eligible persons may request a hearing and the consequences of requesting or failing to request such a hearing (unit VII.).

The Agency's authority to cancel a pesticide that does not comply with the provisions of FIFRA is contained in FIFRA section 6(b), 7 U.S.C. 136d(b).

This announcement will directly affect the pesticide registrant listed in unit I.A., supplemental distributors, and others who may distribute, sell, or use the products listed in unit I.A. This announcement may also be of particular interest to a wide range of stakeholders including environmental, human health, farmworker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. EPA believes the stakeholders described above encompass those likely to be affected; however, more remote interests may also be affected, and the Agency has not attempted to describe all specific entities that may be affected by this action.

With minor exceptions not at issue here, as provided in FIFRA section 3(a), a pesticide product may not be lawfully sold or distributed in the United States unless and until the product is registered by EPA. 7 U.S.C. 136a(a). A pesticide registration is a license allowing a pesticide product to be sold and distributed and includes a label with use instructions that delineates the specific uses for which the pesticide may be used, including precautions and other terms and conditions established by EPA when it grants the registration.

As a general matter, in order to obtain or maintain a registration for a pesticide under FIFRA, an applicant or registrant must demonstrate that the pesticide satisfies the statutory standard for registration. 7 U.S.C. 136a(c)(5). That standard requires, among other things, that the pesticide perform its intended function without causing “unreasonable adverse effects on the environment.” Id. The term “unreasonable adverse effects on the environment” is defined under FIFRA section 2(bb) as including two parts: (1) “[A]ny unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide” and (2) “[A] human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 346a of title 21.” 7 U.S.C. 136(bb). It is under the second part of the definition that the FIFRA registration standard incorporates the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, safety standard.

EPA establishes, modifies, or revokes tolerances for pesticide residues under FFDCA section 408. 21 U.S.C. 346a. A “tolerance” represents the maximum level for residues of a pesticide legally allowed in or on raw agricultural commodities and processed food. Under the FFDCA, “any pesticide chemical residues in or on a food shall be deemed unsafe,” unless a tolerance or exemption for such residues “is in effect”. 21 U.S.C. 346a(a)(1). In other words, without a tolerance or an exemption from the requirement of a tolerance, pesticide residues in or on food are considered unsafe, as a matter of law. The consequence of having pesticide residues in or on food that are not covered by a tolerance, or an exemption is that the food containing such residues is rendered adulterated under the FFDCA. 21 U.S.C. 342(a)(2)(B). It is a violation of the FFDCA to introduce adulterated food into interstate commerce. 21 U.S.C. 331(a).

Because the FIFRA registration standard incorporates the FFDCA safety standard, a pesticide that results in residues in or on food that are unsafe, which includes residues not covered by a tolerance or tolerance exemption, does not meet the FIFRA registration standard. EPA will not approve any application to register a pesticide with food uses that may reasonably be expected to result in pesticide residues on food without appropriate tolerances or exemptions in place, see 40 CFR 152.112(g), and registrations bearing labeling for food use must be modified or cancelled, pursuant to FIFRA section 6(b).

The burden of demonstrating that a pesticide product satisfies the statutory criteria for registration is at all times on the proponents of the initial or continued registration and continues as long as the registration is in effect. 40 CFR 164.80(b); see also Industrial Union Dept. v. American Petroleum Institute, 448 U.S. 607, 653 n.61 (1980); Stearns Electric Paste v. EPA, 461 F.2d 293 (7th Cir. 1972); Environmental Defense Fund v. EPA, 510 F.2d 1292, 1297 (D.C. Cir. 1975).

Under FIFRA section 6(b), the Agency may issue a notice of its intent to cancel a registration of a pesticide product whenever it appears either that “a pesticide or its labeling or other material required to be submitted does not comply with FIFRA, or when used in accordance with widespread and commonly recognized practice, the pesticide generally causes unreasonable adverse effects on the environment.” 7 U.S.C. 136d(b). The cancellation proposed in the notice shall become final 30 days after publication of the notice, or the date the registrant receives the notice, whichever is later, unless the registrant makes the necessary corrections to the registrations, or a hearing is requested by a person adversely affected by the notice. If a hearing is requested by an adversely affected person, the final order concerning cancellation of the product is not issued until after an administrative hearing.

A cancellation hearing shall be conducted in accordance with the regulations establishing the procedures for hearings under FIFRA set forth at 40 CFR part 164. Under those regulations, the Agency has the burden of presenting an affirmative case for cancellation. 40 CFR 164.80(a). However, the ultimate burden of proof is on the proponent of the registration. 40 CFR 164.80(b); Industrial Union Dept., 448 U.S. at 653, n. 61; Stearns Electric Paste v. EPA, 461 F.2d 293 (7th Cir. 1972). Once the Agency makes its prima facie case that a product's continued use fails to meet the FIFRA standard for registration, the responsibility to demonstrate that the product meets the FIFRA standard is upon the proponents of continued registration. 40 CFR 164.80(b); Dow v. Ruckelshaus, 477 F.2d 1317, 1324 (8th Cir. 1973).

Chlorpyrifos is a broad-spectrum, chlorinated organophosphate insecticide that is registered for a wide variety of food and non-food uses. In September 2007, Pesticide Action Network North America and Natural Resources Defense Council filed a petition with EPA requesting revocation of all chlorpyrifos tolerances alleging that, among other things, the pesticide caused adverse neurodevelopmental effects in children at exposure levels below the Agency's regulatory standard ( i.e., 10% acetylcholinesterase inhibition). See Petition to Revoke All Tolerances and Cancel All Registrations for the Pesticide Chlorpyrifos, available at https://www.regulations.gov, using document identification number EPA-HQ-OPP-2007-1005-0005. Following several years of proposed responses and litigation, EPA issued a final response to the petition on March 29, 2017. See 82 FR 16581, April 5, 2017 (FRL-9960-77). That response denied the many claims of the petition, including by concluding that, despite several years of study, the science addressing neurodevelopmental effects remained unresolved and that further evaluation of the science on this issue during the remaining time for completion of registration review was warranted. See id. at 16590. As permitted under the FFDCA, objections to EPA's denial were filed, and EPA responded to those objections on July 18, 2019. See 84 FR 35555, July 18, 2019 (FRL-9997-06). In its denial of those objections, rather than issuing a determination concerning the safety of chlorpyrifos, EPA denied the objections in part on the grounds that the data concerning neurodevelopmental toxicity were not sufficiently valid, complete, and reliable to meet the petitioners' burden. See id. at 35562. EPA's denial of the petition and denial of objections were subsequently challenged by several advocacy groups and states in the Ninth Circuit.

On April 29, 2021, the Ninth Circuit Court of Appeals ruled against EPA in litigation involving the question of whether the chlorpyrifos tolerances should be revoked. See League of United Latin American Citizens et al., v. Regan, 996 F.3d 673 (9th Cir. 2021) (“ LULAC” ). In that case, the Court concluded that EPA violated the FFDCA by not making a safety determination to support the retention of the chlorpyrifos tolerances, as required under the FFDCA. Consequently, the Court ordered EPA to issue a final rule in which the Agency would either revoke the tolerances (if it could not make the requisite safety finding to leave tolerances in place) or modify the existing chlorpyrifos tolerances, provided that the Agency concurrently issued a safety determination supporting the modified tolerances. The Court imposed a tight deadline for EPA to issue the final rule and told EPA not to engage in further fact-finding or delay. Specifically, the court said: “To be clear, however, this is not an open-ended remand or a remand for further factfinding. The EPA must act based upon the evidence and must immediately revoke or modify chlorpyrifos tolerances. For these reasons, the Court remands this matter to the EPA with instructions to publish a legally sufficient final response to the 2007 Petition within 60 days of the issuance of the mandate.”

In implementing the Court's order within the mandated timeframe, EPA found that it could not make a safety finding to support leaving the current tolerances for residues of chlorpyrifos in place, as required under the FFDCA section 408(b)(2). 21 U.S.C. 346a(b)(2). Under the FFDCA, a tolerance may be left in place only if the Agency determines that the tolerances are safe, i.e., that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residues, including all anticipated dietary exposures and all other exposures for which there is reliable information.” Id. Because EPA found that at the time it could not determine that there was a reasonable certainty that no harm would result from aggregate exposure to chlorpyrifos residues, including all anticipated dietary (food and drinking water) exposures and all other exposures, EPA published the final rule revoking all tolerances for chlorpyrifos in the Federal Register on August 30, 2021. 86 FR 48315, August 30, 2021 (FRL-5993-04-OCSPP) (the Final Rule). As described in greater detail in the Final Rule, the Agency's analysis indicated that aggregate exposures ( i.e., exposures from food, drinking water, and residential exposures), which stem from then-currently registered uses, exceeded safe levels. Id. at 48317. That analysis relied on the well-established 10% red blood cell acetylcholinesterase (RBC AChE) inhibition level as an endpoint for risk assessment and included the FFDCA default tenfold (10X) margin of safety to account for uncertainties related to the potential for adverse neurodevelopmental effects to infants, children, and pregnant women. Id. The Final Rule revoked the chlorpyrifos tolerances but provided a transition period of six months, until February 28, 2022. Id. at 48334.

Pursuant to FFDCA section 408(g)(2), EPA provided an opportunity to file objections to the Final Rule and seek an evidentiary hearing on those objections. See also 21 U.S.C. 346a(g)(2); 40 CFR 178.32(b). In response to the Final Rule, several objections, hearing requests, and requests to stay the Final Rule were filed by parties representing a wide variety of growers and pesticide users. On February 28, 2022, EPA published its order denying all objections, hearing requests, and requests to stay the Final Rule in the Federal Register (87 FR 11222, February 28, 2022) (FRL-5993-05-OCSPP) (the Denial Order). EPA's publication of the Denial Order completed the Agency's administrative process for the Final Rule. Pursuant to the terms of the Final Rule, all chlorpyrifos tolerances expired on February 28, 2022. EPA notes that EPA's Final Rule revoking chlorpyrifos tolerances is a separate final agency action, and as such, comments challenging EPA's action in that Final Rule are outside the scope of this Notice. Gharda and several other grower groups have challenged that rule in the U.S. Court of Appeals for the Eighth Circuit, see Red River Valley Sugarbeet Growers Ass'n et al., v. Regan (9th Cir. No. 22-1422).

Because at this time there are no tolerances or exemptions from the requirement of a tolerance for chlorpyrifos residues in or on food, there is no basis for allowing food uses to remain on chlorpyrifos registered products. See 21 U.S.C. 346a(a)(1). Therefore, between March 1 and March 9 of 2022, after EPA's publication of the Denial Order, EPA issued letters to all registrants of chlorpyrifos products with food uses confirming revocation of the tolerances and recommending that such registrants consider various cancellation and label amendment options. EPA requested that registrants submit a letter formally expressing their intention to submit registration amendments to remove food uses from product labels or to submit a voluntary cancellation for products where all uses are subject to the tolerance revocation by March 30, 2022. All chlorpyrifos registrants to whom that letter was sent have submitted requests to voluntarily cancel their pesticide products and/or label amendments to remove food uses from their chlorpyrifos pesticide product labels, with the exception of Gharda, the registrant of products listed in this Notice. While Gharda submitted requests for voluntary cancellation for some uses and some label amendments, that request does not fully align with the revocation of chlorpyrifos tolerances ( i.e., it does not result in the removal of all food uses from those registered products); therefore, Gharda's products identified in unit I.A. are subject to this Notice.

EPA has determined that the chlorpyrifos registrations listed in unit I.A. must be cancelled because they each bear labeling for use on food crops. Due to the lack of tolerances for residues of chlorpyrifos, these products, bearing labeling for use on food crops, (i) pose unreasonable adverse effects on the environment under FIFRA section 2(bb)(2), 7 U.S.C. 136(bb)(2), because use of chlorpyrifos on food results in unsafe pesticide residues under the FFDCA and (ii) are misbranded and thus not in compliance with FIFRA, 7 U.S.C. 136j(a)(1)(E).

As noted in unit II., tolerances establish the maximum amount of pesticide residues that are allowed in or on a food. In situations where no tolerance exists to cover residues of a particular pesticide in or on food, those residues are “deemed unsafe,” as a matter of law under the FFDCA. 21 U.S.C. 346a(a)(1). As a consequence, a pesticide resulting in residues in or on food for which there is no tolerance does not meet the FIFRA standard for registration. See 7 U.S.C. 136(bb). Moreover, any food containing “unsafe” pesticide chemical residues is “deemed to be adulterated,” and introduction of that food into interstate commerce is a violation of the FFDCA. 21 U.S.C. 342(a)(2)(B), 331(a).

As discussed in unit II., in order to maintain a registration for a pesticide under FIFRA, a registrant has the burden to demonstrate that the pesticide satisfies the statutory standard for registration. 40 CFR 164.80(b); see also 7 U.S.C. 136a(c)(5). One element of that standard is that the pesticide performs its intended function without unreasonable adverse effects on the environment, which is defined under FIFRA section 2(bb) to include “a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 346a of title 21.” 7 U.S.C. 136(bb). The standard referenced in the FIFRA definition is the FFDCA safety standard, i.e., that tolerances, which cover the amount of pesticide residues in or on food, must be safe. See 21 U.S.C. 346a(b)(2).

Also noted in unit II., it is a matter of law that pesticide chemical residues in or on food are “deemed unsafe,” unless covered by a tolerance or exemption. 21 U.S.C. 346a(a)(1). Any residues from pesticides used on food where no tolerances exist for those residues are, therefore, unsafe. Unsafe residues are not consistent with the FFDCA safety standard. Thus, any pesticide resulting in such residues, causes, as a legal matter, unreasonable adverse effects on the environment. Such pesticide is subject to cancellation under FIFRA section 6(b).

Because all tolerances for chlorpyrifos have been revoked, chlorpyrifos residues in or on food are unsafe as a matter of law. Because the chlorpyrifos registrations listed in unit I.A. bear labeling for use on food, use of which would result in unsafe pesticide residues on food, these products pose unreasonable adverse effects on the environment under FIFRA section 2(bb)(2). 7 U.S.C. 136(bb)(2).

Additionally, because the chlorpyrifos products in unit I.A. bear labeling for use on food, for which the registrant did not submit the necessary label amendments and/or cancellations to remove all food uses, and because all tolerances for chlorpyrifos have been revoked, these products are misbranded and thus not in compliance with FIFRA. It is a violation of FIFRA to sell and distribute pesticides that are misbranded. 7 U.S.C. 136j(a)(1)(E). FIFRA's definition of “misbranded” provides many ways in which a pesticide may be misbranded, including if its labeling “bears any statement . . . that is false or misleading.” 7 U.S.C. 136(q)(1)(A). Pesticide labeling bearing directions for use on food crops that results in adulterated food is misleading because it is illegal to distribute that food in commerce. A commercial farmer complying with approved use directions would apply the pesticide to crops but then, in the absence of necessary tolerances or an exemption, would be producing adulterated food, which cannot be delivered into interstate commerce without violating the FFDCA. Thus, the label misleads the consumer into believing a pesticide can be applied to food crops, but ultimately results in adulterated food or feed crops that cannot be sold. To avoid this conflict, EPA's regulations prevent EPA from issuing a registration for a pesticide that “bears labeling with directions for use on food, animal feed, or food or feed crops, or may reasonable be expected to result, directly or indirectly, in pesticide residues (or results of any active or inert ingredient of the product, or of any metabolite or degradate thereof) in or on food or animal feed,” unless tolerances or exemptions covering such residues have been issued. 40 CFR 152.112(g).

In summary, because the aforementioned products would result in pesticide residues in or on food that are, as a matter of law, unsafe, the products pose unreasonable adverse effects on the environment. Moreover, EPA has determined that because the aforementioned products are misbranded, continued sale and distribution would not comply with the provisions of FIFRA. Consequently, EPA has determined that these products must be cancelled.

The cancellation of registration for the specific products identified in unit I.A. of this document will be final and effective 30 days after the affected registrant receives notice of EPA's intent to cancel the pesticide registrations listed in unit I.A., or on January 13, 2023, unless within that time the registrant makes the necessary corrections (see unit V.C.) or a hearing is requested by an adversely affected person regarding such product. 7 U.S.C. 136d(b).

In the event a hearing is held concerning a particular product, the cancellation of the registration for that product will not become effective except pursuant to (i) an initial decision of the presiding Administrative Law Judge that becomes a final order pursuant to 40 CFR 164.90(b) or (ii) if the Administrative Law Judge's initial decision is appealed or subject to Administrator review pursuant to 40 CFR 164.101, a final order issued by the Environmental Appeals Board or (if the matter is referred to the Administrator pursuant to 40 CFR 164.2(g)) the Administrator. Final cancellation orders following a public hearing are subject to judicial review within 60 days of the entry of the order. 7 U.S.C. 136d(h).

FIFRA section 6(a)(1) allows the Agency to permit the continued sale and use of existing stocks of pesticides whose use has been cancelled, to the extent the Administrator determines that such sale or use would not be inconsistent with the purposes of this Act. 7 U.S.C. 136d(a)(1). EPA has defined “existing stocks” as “those stocks of a registered pesticide which are currently in the United States and which have been packaged, labeled, and released for shipment prior to the effective date of the cancellation action.” 56 FR 29362, June 26, 1991 (FRL-3846-4). This section addresses how the Agency intends to treat existing stocks when and if pesticide registrations are cancelled pursuant to this Notice.

The Agency does not believe that continued sale or use of existing stocks of any chlorpyrifos registrations identified in this Notice following cancellation would be consistent with FIFRA. The continued sale and distribution of products cancelled in a proceeding pursuant to this Notice would be the sale and distribution of misbranded products, which, if used in accordance with the labeling, would lead to the production of adulterated food and the use of products that would pose unreasonable adverse effects on human health due to residues in or on food that are inconsistent with the FFDCA safety standard. Accordingly, EPA has determined that the continued sale and distribution of existing stocks of pesticide products cancelled pursuant to this Notice should not be permitted, with the exception of movement of existing stocks for the sole purposes of lawful export consistent with FIFRA; disposal consistent with applicable state disposal requirements; or return to the registrant consistent with the terms of a return program agreement with EPA, if any. Moreover, EPA does not intend to allow existing stocks in the hands of end-users to continue to be used, unless they are being used for non-food uses. Any use of chlorpyrifos on food would result in adulterated food, which is illegal to deliver into interstate commerce; therefore, use of existing stocks for use on food cannot be permitted.

It is settled law that existing stocks issues are not required to be a part of a cancellation proceeding, and that the treatment of existing stocks issues is only included as an issue in a cancellation proceeding when the Notice giving rise to the right to a hearing voluntarily identifies and includes existing stocks as an issue for examination. See In the Matter of Cedar Chemical Co., et al., 2 E.A.D. 584, nn. 7, 9, 1988 WL 525242 (June 9, 1988) (Decision of the Administrator). The Administrator's decision in Cedar Chemical on whether existing stocks had to be included as an issue in the hearing was affirmed by the United States Court of Appeals for the Ninth Circuit in Northwest Food Processors Association v. Reilly, 886 F. 2d 1075, 1078 (9th Cir. 1989). In the case of this Notice, EPA has determined not to include existing stocks as an issue in any hearing arising from this Notice, since the lack of tolerances means that any continued sale, distribution, or use of the pesticide would be inconsistent with the purposes of FIFRA. Instead, the only issue for hearing under this Notice is whether the subject products should be cancelled.

FIFRA section 6(b) allows the registrant, within the 30 days following publication or receipt of EPA's notice, to “make the necessary corrections, if possible”. 7 U.S.C. 136d(b). As noted in unit IV., the chlorpyrifos products listed in unit I.A. must be cancelled because they bear labeling for use on food although no tolerances exist to cover chlorpyrifos residues in or on food for those uses. Terminating food uses and removing those uses from labels would resolve the violations EPA has identified in this Notice. Therefore, EPA recognizes that the registrant has an opportunity to make corrections by requesting cancellation of these uses and amending labels.

FIFRA section 6(b) also states “in taking any final action under this subsection, the Administrator shall consider restricting a pesticide's use or uses as an alternative to cancellation and shall fully explain the reasons for these restrictions, and shall include among those factors to be taken into account the impact of such final action on production and prices of agricultural commodities, retail food prices, and otherwise on the agricultural economy, and the Administrator shall publish in the Federal Register an analysis of such impact.” Id.

Accordingly, in any final action on this Notice, EPA may consider, as an alternative to cancellation of the whole registrations, cancelling only those uses that result in residues in or on food. As part of its registration review of chlorpyrifos, EPA considered the potential economic impacts on growers if chlorpyrifos use was eliminated for various registered food crops. See Revised Benefits of Agricultural Uses of Chlorpyrifos (PC# 059101) (November 18, 2020), available at https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0969; Chlorpyrifos Revocation Small Business and Employment Analysis (August 12, 2021), available at https://www.regulations.gov/document/EPA-HQ-OPP-2021-0523-0031. Although EPA may consider benefits for certain uses under FIFRA, economic impacts to growers is not a consideration for EPA in making a safety determination under the FFDCA. Because EPA determined that the tolerances did not meet the safety standard under the FFDCA, EPA revoked all chlorpyrifos tolerances. See 86 FR 48315. As a result, chlorpyrifos may not be used in or on food without resulting in adulterated food, which cannot be distributed in interstate commerce. Restricting the chlorpyrifos products listed in unit I.A. to only those uses that do not result in residues in or on food would have no economic impact, beyond the impact already resulting from the revocation of the chlorpyrifos tolerances, since these products already cannot be used on food due to the lack of tolerances.

When EPA intends to issue a NOIC, it must furnish a draft of that Notice and an analysis of the impact of the proposed action on the agricultural economy to the Secretary of the USDA for comment at least 60 days prior to sending such Notice to the registrant or making such Notice public. 7 U.S.C. 136d(b). When a public health use is affected, FIFRA section 6(b) also directs the Secretary of the Department of Health and Human Services (HHS) to provide available benefits and use information, or an analysis thereof. Within the same time period, the Agency must also submit the proposed cancellation action to the FIFRA Scientific Advisory Panel (SAP) for comment concerning the impact of the proposed action on health and the environment, unless the SAP agrees to waive its review. 7 U.S.C. 136w(d).

In the event that written comments are received from the USDA, HHS, or the SAP within 30 days of such referral, the Agency must publish those comments and the Agency's response to the comments.

Because all tolerances for chlorpyrifos have already been revoked for the reasons set forth in the Final Rule and Denial Order, this proposed cancellation action itself is not anticipated to have any impacts on the agricultural economy. This NOIC is purely an administrative action to address three registrations that the registrant is unable or unwilling to cancel or modify to comply with the Agency's tolerance revocation. EPA provided a draft of this NOIC to the SAP requesting a waiver due to the lack of scientific issues for consideration by the SAP. The SAP waived its review of this NOIC on August 19, 2022.

This NOIC is not subject to review by HHS because there are no public health uses affected by this NOIC.

On August 11, 2022, EPA provided a draft of this NOIC to USDA for review and received a response from USDA on September 11, 2022. USDA expressed three major concerns in its comments: (1) that an economic analysis was not provided for review in conjunction with the draft NOIC; (2) USDA's opinion that historical precedent and procedures was not followed; and (3) USDA's opinion that EPA could have retained some tolerances consistent with the proposal in the Proposed Interim Registration Review Decision for Chlorpyrifos (2020 PID) instead of revoking all tolerances and should initiate action to reestablish tolerances consistent with the conclusions of the 2020 PID. USDA's comments are available at https://www.regulations.gov in the docket for this action, docket ID EPA-HQ-OPP-2022-0417.

The Agency has considered each of these comments prior to finalizing this Notice. Below is a summary of these comments and the Agency's detailed responses to these comments.

Comment: USDA notes that FIFRA requires EPA to consider the impact of the action proposed in the NOIC on production and prices of agricultural commodities, retail food prices, and otherwise on the agricultural economy and to provide that analysis to the USDA. USDA expressed concern with statements in EPA's draft NOIC that the cancellation of the products would produce no negative effects beyond those that were already imposed when EPA revoked the chlorpyrifos tolerances. Since, as USDA notes in their comments, the FFDCA does not provide for consideration of economic impacts in a determination of whether to retain tolerances, the USDA had concerns about the lack of consideration to the economy.

EPA Response: As noted in unit III, EPA revoked the chlorpyrifos tolerances in a final rule issued in August 2021, as a result of concluding that the chlorpyrifos tolerances were not safe. As USDA recognizes, the FFDCA does not authorize EPA to consider economic impacts to farmers when determining whether to retain tolerances. As noted in the Final Rule and the Denial Order, the FFDCA permits EPA to leave a tolerance in place only if it is safe; whether a tolerance is important to the agricultural economy is not a permissible consideration for EPA in determining whether to leave a tolerance in place.

When the tolerances were revoked, chlorpyrifos was no longer permitted to be used on food crops. Although not a consideration under the FFDCA, as part of its assessment of chlorpyrifos in registration review, EPA prepared a benefits assessment and a small business analysis of the economic benefits of chlorpyrifos for a variety of crops as well as the potential economic impact if chlorpyrifos were not available. See Revised Benefits of Agricultural Uses of Chlorpyrifos (PC# 059101) (November 18, 2020), available at https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0969; Chlorpyrifos Revocation Small Business and Employment Analysis (August 12, 2021), available at https://www.regulations.gov/document/EPA-HQ-OPP-2021-0523-0031.

Although the benefits assessment and small business analysis did indicate some economic impacts as a result of chlorpyrifos not being available for growers, those impacts have already occurred as a result of the revocation of the tolerances and would not be attributable to the cancellation of these products. Even if these products were not cancelled, the products could still not be used as a result of the tolerance revocation; thus, the same economic impact would result with or without this cancellation action. To the extent the products being cancelled are registered for non-food uses, these are not the only chlorpyrifos products registered for these non-food uses. Consequently, EPA concluded that the cancellation action being proposed in this NOIC itself does not actually result in any impact on agricultural commodities, retail food prices, or the agricultural economy.

Comment: USDA notes that it considers EPA's process for revoking tolerances as “harmful precedent” that has created confusion and concern among agricultural stakeholders and international trading partners. USDA asserts that the lack of a phase-out period has caused a widespread disposal problem for existing stocks of chlorpyrifos, and that the “divergence from normal procedures caused confusion and concerns” and may “harm the economic viability of U.S. producers in the long-term” by undercutting U.S. credibility in future trade negotiations.

EPA Response: As an initial matter, EPA notes that this comment does not appear to be directly relevant to the cancellation of the particular products identified in this NOIC, but rather a commentary on EPA's issuance and implementation of the final rule revoking tolerances. Prior to the issuance of the final rule, EPA coordinated with FDA and USDA to ensure they could develop any necessary enforcement guidance, such as how long legally treated food and feed commodities may be in the channels of trade, and FDA released a document entitled Guidance for Industry: Questions and Answers Regarding Channels of Trade Policy for Human Food Commodities with Chlorpyrifos Residues, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-channels-trade-policy-human-food-commodities, in order to provide guidance to stakeholders in the food industry. In addition, in the Final Rule itself and contrary to the USDA's assertion, EPA did provide a six-month transition period between the publication of the final revoking tolerances and the effective date of the revocation consistent with the Agency's obligations under the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures. Although EPA recognizes that there has been confusion in the regulated community on what to do with registered chlorpyrifos products that can no longer be used on food, EPA is, and has been, working with registrants to provide for an appropriate transition. Specifically, the Agency continues to work with the registrants in the development of their return programs and update stakeholders and the Agency's website with the latest information regarding chlorpyrifos.

To the extent this comment expressed a concern about the process EPA used for terminating use of chlorpyrifos on food, EPA fully addressed this comment in its Denial Order. See 87 FR at 11247-49. Objectors to EPA's Final Rule alleged that EPA was required to negotiate with chlorpyrifos registrants and cancel food uses under FIFRA before revoking tolerances under the FFDCA. Consistent with EPA's position in the Denial Order, neither FIFRA nor the FFDCA direct that the Agency proceed with cancellation under FIFRA prior to revoking tolerances under the FFDCA. Id. Where EPA determines that tolerances are not safe, the FFDCA requires that tolerances be revoked, regardless of the economic impact of that revocation. In addition, in this particular instance, the Ninth Circuit prioritized the Agency taking action under the FFDCA over taking action under FIFRA, by ordering EPA to take action on the tolerances within 60 days of the issuance of the mandate in that case, i.e., August 20, 2021, and to take action to cancel food uses “in a timely fashion”. LULAC, 996 F.3d. at 703-04.

Nonetheless, even with the restricted timeframe imposed by the Ninth Circuit and the need to prioritize tolerance actions under the FFDCA over cancellations under FIFRA, EPA did attempt to coordinate the tolerance revocations with cancellation actions. While EPA was unable to complete the necessary steps for that process to impact the tolerance revocation rule for chlorpyrifos by the Court's deadline, EPA recognizes that coordinating tolerance revocations and FIFRA cancellations can be helpful since product cancellation orders can provide clarity around existing stocks and disposal procedures.

Comment: USDA's comments outline its opinion that the Agency could have pursued a pathway on the 11 high benefit uses outlined in the 2020 PID instead of revoking all tolerances. USDA also requests Agency-initiated action to reestablish tolerances consistent with the conclusions of the 2020 PID.

EPA Response: EPA notes that this comment appears to be more appropriately directed towards the Final Rule itself rather than the cancellation action that is the subject of this NOIC. Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of the 2021 final tolerance rule and may also request a hearing on those objections. USDA did not file any such objection, although several other parties did, asserting that EPA should have left tolerances in place associated with 11 uses as described in the 2020 PID rather than revoking all the tolerances. EPA denied that objection in its Denial Order. See 87 FR at 11244-47. The Denial Order fully explained the rationale for not adopting the proposal presented in the 2020 PID. Briefly, in the December 2020 PID, EPA proposed that all chlorpyrifos uses contributing aggregate exposures be cancelled except for 11 specific uses in specific geographic areas. Those 11 uses were identified by registrants and EPA as having high benefits, although the Agency recognized that it was just one possible subset of uses that might be retainable. The Agency's proposed safety determination for those uses was contingent on other uses being cancelled and additional use restrictions being in effect. It is also important to note that the findings in the PID were simply proposals, and those proposals, and the underlying risk assessments on which those proposals were based, were subject to public comment and did not represent a final safety determination. Despite the potential for supporting a safety finding consistent with the PID, at the time that EPA was required to expeditiously issue a rule by the Ninth Circuit, no concrete steps had been taken by registrants under FIFRA to implement the PID proposal: no uses had been cancelled, no labels had been revised to geographically limit applications or limit maximum application rates, nor had any applications to initiate such actions been filed with the Agency. Therefore, at the time of the Final Rule, the option to leave certain tolerances in place was not available. Thus, EPA assessed aggregate exposure based on all currently registered uses of chlorpyrifos as required by the FFDCA and consistent with its guidance, finding that it could not determine that there was a reasonable certainty of no harm from aggregate exposure. As a result, chlorpyrifos tolerances were revoked and expired as of February 28, 2022.

A challenge to the Final Rule is outside the scope of this NOIC. All the chlorpyrifos tolerances have been revoked, so the products identified in this document must be cancelled because they bear labeling for use on food. As noted above, the Agency views this NOIC as an administrative action, as once tolerances were revoked, chlorpyrifos products cannot bear labeling for use on food, since the products could no longer be used without rendering food and feed crops adulterated.

The request to reestablish tolerances associated with those 11 uses is also outside the scope of this NOIC. At this time, the Agency does not intend to initiate a rulemaking to re-establish those tolerances. Initiating tolerance rulemaking under section 408(e) of the FFDCA is a discretionary action, 21 U.S.C. 346a(e), and at this time, no petition has been submitted requesting specific tolerances to be established under section 408(d) of the FFDCA, 21 U.S.C. 346a(d). Even if EPA initiated such a rulemaking, or if a petition were submitted, EPA would need to follow the statutory process and make a determination that the tolerances were safe in order to establish them. It is important to note that the proposal in the 2020 PID was only a proposed safety finding based on a subset of uses; it was not a final determination of safety. Any final safety determination supporting the re-establishment of the tolerances would need to take into consideration aggregate exposures to chlorpyrifos.

This unit explains how eligible persons may request a hearing and the consequences of requesting or failing to request such a hearing.

A registrant or any other person who is adversely affected by a cancellation of registration as described in this Notice may request a hearing.

A request for a hearing by a registrant must be submitted in writing within 30 days after the date of receipt of the NOIC, or within 30 days after publication of this announcement in the Federal Register , whichever occurs later. A request for a hearing by any other person adversely affected by the Agency's proposed action must be submitted within 30 days after the date of publication of this Notice in the Federal Register . See the DATES section of this document.

All persons who request a hearing must comply with the Agency's Rules of Practice Governing Hearings, 40 CFR part 164. Among other requirements, these rules include the following requirements:

• Each hearing request must specifically identify by registration or accession number each individual pesticide product for which a hearing is requested, 40 CFR 164.22(a);

• Each hearing request must be accompanied by a document setting forth specific objections that respond to the Agency's reasons for proposing cancellation as set forth in this Notice, and stating the factual basis for each such objection, 40 CFR 164.22(a); and

• Each hearing request must be received by the OALJ within the applicable 30-day period, 40 CFR 164.5(a).

Failure to comply with any one of these requirements will invalidate the request for a hearing and, in the absence of a valid hearing request, result in final cancellation for the products in question by operation of law.

Requests for hearing must be submitted to the OALJ. The OALJ strongly encourages electronic filing due to the coronavirus pandemic. See Order Urging Electronic Service and Filing, issued by Chief ALJ Biro (April 10, 2020), available at https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.

1. Submitting the hearing request electronically. To file a document electronically, a party shall use a web-based tool known as the OALJ E-Filing System by visiting the OALJ's website at https://www.epa.gov/alj. Documents filed electronically are deemed to constitute both the original and one copy of the document.

Any party choosing to file electronically must first register with the OALJ E-Filing System at https://yosemite.epa.gov/oa/eab/EAB-ALJ_Upload.nsf. There may be a delay of one to two business days between the time a party applies for registration and the time at which the party is able to upload documents into the system.

A document submitted to the OALJ E-Filing System is considered “filed” at the time and date of electronic reception, as recorded by the OALJ E-Filing System immediately upon reception. To be considered timely, documents submitted through the OALJ E-Filing System must be received by 11:59 p.m. Eastern Time on the date the document is due, unless another time is specified by the Judge. Within an hour of a document being electronically filed, the OALJ E-Filing System will generate an electronic receipt of the submission that will be sent by email to both the party submitting the document and the Headquarters Hearing Clerk. This emailed electronic receipt will be the filing party's only proof that the OALJ received the submitted document. The absence or presence of a document on the OALJ's E-Docket Database web page, available at https://yosemite.epa.gov/oarm/alj/alj_web_docket.nsf, or on the Agency's Administrative Enforcement Dockets web page, available at https://yosemite.epa.gov/oa/rhc/epaadmin.nsf, is not proof that the document was or was not received. If the filing party does not receive an electronic receipt within one hour after submitting the document through the OALJ E-Filing System, the Headquarters Hearing Clerk may be able to confirm receipt of the document but not earlier than one hour after the document was submitted.

The OALJ E-Filing System will accept any type of digital file, but the file size is limited to 70 megabytes. Electronically filed textual documents must be in Portable Document Format (“PDF”). If a party's multimedia file exceeds 70 megabytes, the party may save the file on a compact disc and send it by U.S. mail to the Hearing Clerk mailing address identified in unit VII.D.2. of this Notice, or the party may contact the Headquarters Hearing Clerk at (202) 564-6281 for instructions on alternative electronic filing methods.

A motion and any associated brief may be filed together through the OALJ E-Filing System. However, any documents filed in support of a brief, motion, or other filing, such as copies of proposed exhibits submitted as part of party's prehearing exchange, should be filed separately as an attachment. Where a party wishes to file multiple documents in support of a brief, motion, or other filing, rather than filing a separate attachment for each such document, the documents should be compiled into a single electronic file and filed as a single attachment, to the extent technically practicable.

2. Submitting the hearing request by non-electronic means. Alternatively, if a party is unable to file a document utilizing the OALJ E-Filing System, e.g., the party lacks access to a computer, the party may file the document by U.S. mail or facsimile, although the OALJ's ability to receive filings via those methods is limited. U.S. mail is currently being delivered to the OALJ at an offsite location on a weekly basis only, and documents sent by facsimile will also be received offsite. If a party must file documents by U.S. mail or facsimile, the party shall notify the Headquarters Hearing Clerk each time it files a document in such a manner by calling (202) 564-6281.

To file a document using U.S. mail, the document shall be sent to the following mailing address: Mary Angeles, Headquarters Hearing Clerk, Office of Administrative Law Judges (Mail Code 1900R), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460.

Please note that mail deliveries to federal agencies are screened off-site, and this security procedure can delay delivery.

Facsimile may be used to file a document if it is fewer than 20 pages in length. To file a document using facsimile, the document shall be sent to OALJ's offsite location at (916) 550-9639.

A document submitted by U.S. mail or facsimile is considered “filed” when the Headquarters Hearing Clerk physically receives it, as reflected by the inked date stamp physically applied by the Headquarters Hearing Clerk to the paper copy of the document.

At this time, the OALJ is not able to accept filings or correspondence by courier or commercial delivery service, such as UPS, FedEx, and DHL. Likewise, the physical office of the OALJ is not currently accessible to the public, and the OALJ is not able to receive documents by personal delivery. For further information on filings with the OALJ, please see https://www.epa.gov/alj.

3. Important reminders. Regardless of the method of filing, all filed documents must be signed in accordance with 40 CFR part 164 and must contain the contact name, telephone number, mailing address, and email address of the filing party or its authorize representative. A copy of each document filed in this proceeding shall also be “served” by the filing party on the presiding judge and on all other parties.

If a hearing concerning any product affected by this Notice is requested in a timely and effective manner, the hearing will be governed by the Agency's Rules of Practice Governing Hearings, 40 CFR part 164, and the procedures set forth in this unit. Any interested person may participate in the hearing, in accordance with 40 CFR 164.31.

EPA's Rules of Practice forbid anyone who may take part in deciding this case, at any stage of the proceeding, from discussing the merits of the proceeding ex parte with any party or with any person who has been connected with the preparation or presentation of the proceeding as an advocate or in any investigative or expert capacity, or with any of their representatives. 40 CFR 164.7. To facilitate compliance with the ex parte rule, the following are designated as adjudicatory personnel for purposes of this proceeding: the Administrative Law Judges and their staff and the Environmental Appeals Board and its staff. None of the persons identified as adjudicatory personnel may discuss the merits of the proceeding with any person with an interest in the proceeding, or representative of such person, except in compliance with 40 CFR 164.7.

This action is directed to the public in general and may be of interest to those involved in the manufacture, processing, distribution, use, disposal, and/or the assessment of risks involving chemical substances and mixtures. You may be potentially affected by this action if you manufacture (defined under TSCA to include import), process (including recycling), distribute in commerce, use or dispose of PCE, including PCE in products. Since other entities may also be interested in this revision to the risk determination, EPA has not attempted to describe all the specific entities that may be affected by this action.

TSCA section 6, 15 U.S.C. 2605, requires EPA to conduct risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation (PESS) identified as relevant to the risk evaluation by the Administrator, under the conditions of use. 15 U.S.C. 2605(b)(4)(A). TSCA sections 6(b)(4)(A) through (H) enumerate the deadlines and minimum requirements applicable to this process, including provisions that provide instruction on chemical substances that must undergo evaluation, the minimum components of a TSCA risk evaluation, and the timelines for public comment and completion of the risk evaluation. TSCA also requires that EPA operate in a manner that is consistent with the best available science, make decisions based on the weight of the scientific evidence, and consider reasonably available information. 15 U.S.C. 2625(h), (i), and (k).

The statute identifies the minimum components for all chemical substance risk evaluations. For each risk evaluation, EPA must publish a document that outlines the scope of the risk evaluation to be conducted, which includes the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations that EPA expects to consider. 15 U.S.C. 2605(b)(4)(D). The statute further provides that each risk evaluation must also: (1) integrate and assess available information on hazards and exposures for the conditions of use of the chemical substance, including information that is relevant to specific risks of injury to health or the environment and information on relevant potentially exposed or susceptible subpopulations; (2) describe whether aggregate or sentinel exposures were considered and the basis for that consideration; (3) take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the conditions of use; and (4) describe the weight of the scientific evidence for the identified hazards and exposures. 15 U.S.C. 2605(b)(4)(F)(i) through (ii) and (iv) through (v). Each risk evaluation must not consider costs or other nonrisk factors. 15 U.S.C. 2605(b)(4)(F)(iii).

EPA has inherent authority to reconsider previous decisions and to revise, replace, or repeal a decision to the extent permitted by law and supported by reasoned explanation. FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009); see also Motor Vehicle Mfrs. Ass'n v. State Farm Mutual Auto. Ins. Co., 463 U.S. 29, 42 (1983). Pursuant to such authority, EPA has reconsidered and is now finalizing a revised risk determination for PCE.

EPA is announcing the availability of the final revision to the risk determination for the PCE risk evaluation issued under TSCA that published in December 2020 (Ref. 1). In June 2022, EPA sought public comment on the draft revisions (87 FR 39085, June 30, 2022). EPA appreciates the public comments received on the draft revision to the PCE risk determination. After review of these comments and consideration of the specific circumstances of PCE, EPA concludes that the Agency's risk determination for PCE is better characterized as a whole chemical risk determination rather than condition-of-use-specific risk determinations. Accordingly, EPA is revising and replacing section 5 of the December 2020 PCE Risk Evaluation (Ref. 2) where the findings of unreasonable risk to health were previously made for the individual conditions of use evaluated. EPA is also withdrawing the previously issued TSCA section 6(i)(l) order for two conditions of use previously determined not to present unreasonable risk which was included in section 5.4.1 of the December 2020 PCE Risk Evaluation (Ref. 2).

This final revision to the PCE risk determination is consistent with EPA's plans to revise specific aspects of the first ten TSCA chemical risk evaluations to ensure that the risk evaluations better align with TSCA's objective of protecting health and the environment. As a result of this revision, removing the assumption that workers always and appropriately wear PPE (see Unit II.C.) means that: one condition of use in addition to the original 59 conditions of use drives the unreasonable risk for PCE; an additional route of exposure ( i.e., inhalation) is also identified as driving the unreasonable risk to workers in many of those 59 conditions of use; and additional risks for acute non-cancer effects and cancer from inhalation and dermal exposures also drive the unreasonable risk in many of those 59 conditions of use (where previously those conditions of use were identified as presenting unreasonable risk only for chronic non-cancer effects or for chronic non-cancer effects and cancer). However, EPA is not making condition-of-use-specific risk determinations for those conditions of use, and for purposes of TSCA section 6(i), EPA is not issuing a final order under TSCA section 6(i)(1) for the condition of use that does not drive the unreasonable risk and does not consider the revised risk determination to constitute a final agency action at this point in time. Overall, 60 conditions of use out of 61 EPA evaluated drive the PCE whole chemical unreasonable risk determination due to risks identified for human health. The full list of the conditions of use evaluated for the PCE TSCA risk evaluation is in Table 1-4 of the December 2020 PCE Risk Evaluation (Ref. 2).

In accordance with Executive Order 13990 (“Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis”) and other Administration priorities (Refs. 3, 4, 5, and 6), EPA reviewed the risk evaluations for the first ten chemical substances, including PCE, to ensure that they meet the requirements of TSCA, including conducting decision-making in a manner that is consistent with the best available science.

As a result of this review, EPA announced plans to revise specific aspects of the first ten risk evaluations in order to ensure that the risk evaluations appropriately identify unreasonable risks and thereby help ensure the protection of human health and the environment (Ref. 7). Following a review of specific aspects of the December 2020 PCE Risk Evaluation (Ref. 2) and after considering comments received on a draft revised risk determination for PCE, EPA has determined that making an unreasonable risk determination for PCE as a whole chemical substance, rather than making unreasonable risk determinations separately on each individual condition of use evaluated in the risk evaluation, is the most appropriate approach for PCE under the statute and implementing regulations. In addition, EPA's final risk determination is explicit insofar as it does not rely on assumptions regarding the use of PPE in making the unreasonable risk determination under TSCA section 6, even though some facilities might be using PPE as one means to reduce worker exposures; rather, the use of PPE as a means of addressing unreasonable risk will be considered during risk management, as appropriate.

Separately, EPA is conducting a screening approach to assess risks from the air and water pathways for several of the first 10 chemicals, including this chemical. For PCE the exposure pathways that were or could be regulated under another EPA administered statute were excluded from the final risk evaluation (see section 1.4.2 of the December 2020 PCE Risk Evaluation). This resulted in the ambient air and ambient water pathways for PCE not being assessed. The goal of the recently-developed screening approach is to remedy this exclusion and to determine if there may be risks that were unaccounted for in the PCE risk evaluation.

The screening-level approach has gone through public comment and independent external peer review through the SACC. The Agency received the final peer review report on May 18, 2022, and has reviewed public comments and SACC comments. EPA expects to describe its findings regarding the chemical-specific application of this screening-level approach in the forthcoming proposed rule under TSCA section 6(a) for PCE.

This action pertains only to the risk determination for PCE. While EPA intends to consider and may take additional similar actions on other of the first ten chemicals, EPA is taking a chemical-specific approach to reviewing these risk evaluations and is incorporating new policy direction in a surgical manner, while being mindful of Congressional direction on the need to complete risk evaluations and move toward any associated risk management activities in accordance with statutory deadlines.

TSCA section 6 repeatedly refers to determining whether a chemical substance presents unreasonable risk under its conditions of use. Stakeholders have disagreed over whether a chemical substance should receive: A single determination that is comprehensive for the chemical substance after considering the conditions of use, referred to as a whole-chemical determination; or multiple determinations, each of which is specific to a condition of use, referred to as condition-of-use-specific determinations.

As explained in the Federal Register document announcing the availability of the draft revised risk determination for PCE (87 FR 39085, June 30, 2022 (FRL-9942-01-OCSPP)), the proposed Risk Evaluation Procedural Rule (Ref. 8) was premised on the whole chemical approach to making unreasonable risk determinations. In that proposed rule, EPA acknowledged a lack of specificity in statutory text that might lead to different views about whether the statute compelled EPA's risk evaluations to address all conditions of use of a chemical substance or whether EPA had discretion to evaluate some subset of conditions of use ( i.e., to scope out some manufacturing, processing, distribution in commerce, use, or disposal activities), but also stated that “EPA believes the word `the' [in TSCA section 6(b)(4)(A)] is best interpreted as calling for evaluation that considers all conditions of use.” The proposed rule, however, was unambiguous on the point that unreasonable risk determinations would be for the chemical substance as a whole, even if based on a subset of uses. See Ref. 8 at pages 7565-66 (“TSCA section 6(b)(4)(A) specifies that a risk evaluation must determine whether `a chemical substance' presents an unreasonable risk of injury to health or the environment `under the conditions of use.' The evaluation is on the chemical substance—not individual conditions of use—and it must be based on `the conditions of use.' In this context, EPA believes the word `the' is best interpreted as calling for evaluation that considers all conditions of use.”). In the proposed regulatory text, EPA proposed to determine whether the chemical substance presents an unreasonable risk of injury to health or the environment under the conditions of use. (Ref. 8 at 7480.)

The final Risk Evaluation Procedural Rule stated (82 FR 33726, July 20, 2017 (FRL-9964-38)) (Ref. 9): “As part of the risk evaluation, EPA will determine whether the chemical substance presents an unreasonable risk of injury to health or the environment under each condition of uses [sic] within the scope of the risk evaluation, either in a single decision document or in multiple decision documents” (40 CFR 702.47). For the unreasonable risk determinations in the first ten risk evaluations, EPA applied this provision by making individual risk determinations for each condition of use evaluated as part of each risk evaluation document ( i.e., the condition-of-use-specific approach to risk determinations). That approach was based on one particular passage in the preamble to the final Risk Evaluation Rule which stated that EPA will make individual risk determinations for all conditions of use identified in the scope. (Ref. 9 at 33744).

In contrast to this portion of the preamble of the final Risk Evaluation Rule, the regulatory text itself and other statements in the preamble reference a risk determination for the chemical substance under its conditions of use, rather than separate risk determinations for each of the conditions of use of a chemical substance. In the key regulatory provision excerpted previously from 40 CFR 702.47, the text explains that “[a]s part of the risk evaluation, EPA will determine whether the chemical substance presents an unreasonable risk of injury to health or the environment under each condition of uses [sic] within the scope of the risk evaluation, either in a single decision document or in multiple decision documents” (Ref. 9, emphasis added). Other language reiterates this perspective. For example, 40 CFR 702.31(a) states that the purpose of the rule is to establish the EPA process for conducting a risk evaluation to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment as required under TSCA section 6(b)(4)(B). Likewise, there are recurring references to whether the chemical substance presents an unreasonable risk in 40 CFR 702.41(a). See, for example, 40 CFR 702.41(a)(6), which explains that the extent to which EPA will refine its evaluations for one or more condition of use in any risk evaluation will vary as necessary to determine whether a chemical substance presents an unreasonable risk. Notwithstanding the one preambular statement about condition-of-use-specific risk determinations, the preamble to the final rule also contains support for a risk determination on the chemical substance as a whole. In discussing the identification of the conditions of use of a chemical substance, the preamble notes that this task inevitably involves the exercise of discretion on EPA's part, and “as EPA interprets the statute, the Agency is to exercise that discretion consistent with the objective of conducting a technically sound, manageable evaluation to determine whether a chemical substance—not just individual uses or activities—presents an unreasonable risk” (Ref. 9 at 33729).

Therefore, notwithstanding EPA's choice to issue condition-of-use-specific risk determinations to date, EPA interprets its risk evaluation regulation to also allow the Agency to issue whole-chemical risk determinations. Either approach is permissible under the regulation. A panel of the Ninth Circuit Court of Appeals also recognized the ambiguity of the regulation on this point. Safer Chemicals v. EPA, 943 F.3d. 397, 413 (9th Cir. 2019) (holding a challenge about “use-by-use risk evaluations [was] not justiciable because it is not clear, due to the ambiguous text of the Risk Evaluation Rule, whether the Agency will actually conduct risk evaluations in the manner Petitioners fear”).

EPA plans to consider the appropriate approach for each chemical substance risk evaluation on a case-by-case basis, taking into account considerations relevant to the specific chemical substance in light of the Agency's obligations under TSCA. The Agency expects that this case-by-case approach will provide greater flexibility in the Agency's ability to evaluate and manage unreasonable risk from individual chemical substances. EPA believes this is a reasonable approach under TSCA and the Agency's implementing regulations.

With regard to the specific circumstances of PCE, EPA has determined that a whole chemical approach is appropriate for PCE in order to protect health and the environment. The whole chemical approach is appropriate for PCE because there are benchmark exceedances for a substantial number of conditions of use (spanning across most aspects of the chemical lifecycle—from manufacturing (including import), processing, industrial and commercial use, consumer use, and disposal) for workers, occupational non-users, consumers, and bystanders and risk of irreversible health effects (specifically neurotoxicity and cancer) associated with PCE exposures. Because these chemical-specific properties cut across the conditions of use within the scope of the risk evaluation, a substantial amount of the conditions of use drive the unreasonable risk; therefore, it is appropriate for the Agency to make a determination for PCE that the whole chemical presents an unreasonable risk.

As explained later in this document, the revisions to the unreasonable risk determination (section 5 of the December 2020 PCE Risk Evaluation (Ref. 2)) follow the issuance of a draft revision to the TSCA PCE unreasonable risk determination (87 FR 39085, June 30, 2022) and the receipt of public comment. A response to comments document is also being issued with the final revised unreasonable risk determination for PCE (Ref. 10). The revisions to the unreasonable risk determination are based on the existing risk characterization section of the December 2020 PCE Risk Evaluation (Ref. 2) (section 4) and do not involve additional technical or scientific analysis. The discussion of the issues in this Federal Register document and in the accompanying final revised risk determination for PCE supersede any conflicting statements in the December 2020 PCE Risk Evaluation (Ref. 2) and the earlier response to comments document (Ref. 11). EPA views the peer reviewed hazard and exposure assessments and associated risk characterization as robust and upholding the standards of best available science and weight of the scientific evidence per TSCA sections 26(h) and (i).

For purposes of TSCA section 6(i), EPA is making a risk determination on PCE as a whole chemical. Under the revised approach, the “whole chemical” risk determination for PCE supersedes the no unreasonable risk determinations for PCE that were premised on a condition-of-use-specific approach to determining unreasonable risk and also contains an order withdrawing the TSCA section 6(i)(1) order in section 5.4.1 of the December 2020 PCE Risk Evaluation (Ref. 2).

In the risk evaluations for the first ten chemical substances, as part of the unreasonable risk determination, EPA assumed for several conditions of use that workers were provided and always used PPE in a manner that achieves the stated assigned protection factor (APF) for respiratory protection, or used impervious gloves for dermal protection. In support of this assumption, EPA used reasonably available information such as public comments indicating that some employers, particularly in the industrial setting, provide PPE to their employees and follow established worker protection standards ( e.g., OSHA requirements for protection of workers).

For the December 2020 PCE Risk Evaluation (Ref. 2), EPA assumed, based on reasonably available information that workers use PPE—specifically, respirators with an APF ranging from 25 to 50 and gloves with PF 10 or 20—for 26 occupational conditions of use. In the December 2020 PCE Risk Evaluation, EPA determined that there is unreasonable risk for 25 of those occupational conditions of use.

EPA is revising the assumption for PCE that workers always and properly use PPE. However, this does not mean that EPA questions the veracity of public comments which describe occupational safety practices often followed by industry. EPA believes it is appropriate when conducting risk evaluations under TSCA to evaluate the levels of risk present in baseline scenarios where PPE is not assumed to be used by workers. This approach of not assuming PPE use by workers considers the risk to potentially exposed or susceptible subpopulations of workers who may not be covered by OSHA standards, such as self-employed individuals and public sector workers who are not covered by a State Plan. It should be noted that, in some cases, baseline conditions may reflect certain mitigation measures, such as engineering controls, in instances where exposure estimates are based on monitoring data at facilities that have engineering controls in place.

In addition, EPA believes it is appropriate to evaluate the levels of risk present in scenarios considering applicable OSHA requirements ( e.g., chemical-specific permissible exposure limits (PELs) and/or chemical-specific PELs with additional substance-specific standards), as well as scenarios considering industry or sector best practices for industrial hygiene that are clearly articulated to the Agency. Consistent with this approach, the December 2020 PCE Risk Evaluation (Ref. 2) characterized risk to workers both with and without the use of PPE. By characterizing risks using scenarios that reflect different levels of mitigation, EPA risk evaluations can help inform potential risk management actions by providing information that could be used during risk management to tailor risk mitigation appropriately to address any unreasonable risk identified, or to ensure that applicable OSHA requirements or industry or sector best practices that address the unreasonable risk are required for all potentially exposed and susceptible subpopulations (including self-employed individuals and public sector workers who are not covered by an OSHA State Plan).

When undertaking unreasonable risk determinations as part of TSCA risk evaluations, however, EPA does not believe it is appropriate to assume as a general matter that an applicable OSHA requirement or industry practice related to PPE use is consistently and always properly applied. Mitigation scenarios included in the EPA risk evaluation ( e.g., scenarios considering use of various PPE) likely represent what is happening already in some facilities. However, the Agency cannot assume that all facilities have adopted these practices for the purposes of making the TSCA risk determination (Ref. 12).

Therefore, EPA is making a determination of unreasonable risk for PCE from a baseline scenario that does not assume compliance with OSHA standards, including any applicable exposure limits or requirements for use of respiratory protection or other PPE. Making unreasonable risk determinations based on the baseline scenario should not be viewed as an indication that EPA believes there are no occupational safety protections in place at any location, or that there is widespread non-compliance with applicable OSHA standards. Rather, it reflects EPA's recognition that unreasonable risk may exist for subpopulations of workers that may be highly exposed because they are not covered by OSHA standards, such as self-employed individuals and public sector workers who are not covered by a State Plan, or because their employer is out of compliance with OSHA standards, or because many of OSHA's chemical-specific permissible exposure limits largely adopted in the 1970's are described by OSHA as being “outdated and inadequate for ensuring protection of worker health,” (Ref. 13), or because EPA finds unreasonable risk for purposes of TSCA notwithstanding OSHA requirements.

In accordance with this approach, EPA is finalizing the revision to the PCE risk determination without relying on assumptions regarding the occupational use of PPE in making the unreasonable risk determination under TSCA section 6; rather, information on the use of PPE as a means of mitigating risk (including public comments received from industry respondents about occupational safety practices in use) will be considered during the risk management phase, as appropriate. This represents a change from the approach taken in the December 2020 PCE Risk Evaluation (Ref. 2). As a general matter, when undertaking risk management actions, EPA intends to strive for consistency with applicable OSHA requirements and industry best practices, including appropriate application of the hierarchy of controls, to the extent that applying those measures would address the identified unreasonable risk, including unreasonable risk to potentially exposed or susceptible subpopulations. Consistent with TSCA section 9(d), EPA will consult and coordinate TSCA activities with OSHA and other relevant Federal agencies for the purpose of achieving the maximum applicability of TSCA while avoiding the imposition of duplicative requirements. Informed by the mitigation scenarios and information gathered during the risk evaluation and risk management process, the Agency might propose rules that require risk management practices that may be already common practice in many or most facilities. Adopting clear, comprehensive regulatory standards will foster compliance across all facilities (ensuring a level playing field) and assure protections for all affected workers, especially in cases where current OSHA standards may not apply or be sufficient to address the unreasonable risk.

Removing the assumption that workers always and appropriately wear PPE in making the whole chemical risk determination for PCE means that: one condition of use in addition to the original 59 conditions of use drives the unreasonable risk for PCE; an additional route of exposure ( i.e., inhalation) is also identified as driving the unreasonable risk to workers in many of those 59 conditions of use; and additional risks for acute non-cancer effects and cancer from inhalation and dermal exposures also drive the unreasonable risk in many of those 59 conditions of use (where previously those conditions of use were identified as presenting unreasonable risk only for chronic non-cancer effects or for chronic non-cancer effects and cancer). The finalized revision to the PCE risk determination clarifies that EPA does not rely on the assumed use of PPE when making the risk determination for the whole substance; rather, the use of PPE as a means of addressing unreasonable risk will be considered during risk management, as appropriate.

PCE is a colorless liquid and a volatile organic compound that is manufactured (including imported), processed, distributed, used, and disposed of as part of industrial, commercial, and consumer conditions of use. PCE has a wide range of uses, including production of fluorinated compounds and as a solvent in dry cleaning and vapor degreasing. A variety of consumer and commercial products use PCE, such as adhesives (arts and crafts, as well as light repairs), aerosol degreasers, brake cleaners, aerosol lubricants, sealants, stone polish, stainless steel polish, and wipe cleaners. The total aggregate production volume reported for PCE under the Chemical Data Reporting rule ranged from 324 million to 388 million pounds between 2012 and 2015.

EPA determined that PCE presents an unreasonable risk to health under the conditions of use. EPA's unreasonable risk determination for PCE as a chemical substance is driven by risks associated with the following conditions of use, considered singularly or in combination with other exposures:

• Manufacturing (domestic manufacture);

• Manufacturing (import);

• Processing as a reactant/intermediate;

• Processing into formulation, mixture or reaction product for cleaning and degreasing products;

• Processing into formulation, mixture or reaction product for adhesive and sealant products;

• Processing into formulation, mixture or reaction product for paint and coating products;

• Processing into formulation, mixture or reaction product for other chemical products and preparations;

• Processing by repackaging;

• Recycling;

• Industrial and commercial use as solvent for open-top batch vapor degreasing;

• Industrial and commercial use as solvent for closed-loop batch vapor degreasing;

• Industrial and commercial use as solvent for in-line conveyorized vapor degreasing;

• Industrial and commercial use as solvent for in-line web cleaner vapor degreasing;

• Industrial and commercial use as solvent for cold cleaning;

• Industrial and commercial use as solvent for aerosol spray degreaser/cleaner;

• Industrial and commercial use as a solvent for aerosol lubricants;

• Industrial and commercial use as a solvent for penetrating lubricants and cutting tool coolants;

• Industrial and commercial use in solvent-based adhesives and sealants;

• Industrial and commercial use in solvent-based paints and coatings;

• Industrial and commercial use in maskants for chemical milling;

• Industrial and commercial use as a processing aid in pesticide, fertilizer and other agricultural chemical manufacturing;

• Industrial and commercial use as a processing aid in catalyst regeneration in petrochemical manufacturing;

• Industrial and commercial use in wipe cleaning;

• Industrial and commercial use in other spot cleaning and spot removers, including carpet cleaning;

• Industrial and commercial use in mold release;

• Industrial and commercial use in dry cleaning and spot cleaning post-2006 dry cleaning;

• Industrial and commercial use in dry cleaning and spot cleaning 4th/5th gen only dry cleaning;

• Industrial and commercial use in automotive care products ( e.g., engine degreaser and brake cleaner);

• Industrial and commercial use in non-aerosol cleaner;

• Industrial and commercial use in metal ( e.g., stainless steel) and stone polishes;

• Industrial and commercial use in laboratory chemicals;

• Industrial and commercial use in welding;

• Industrial and commercial use in other textile processing;

• Industrial and commercial use in wood furniture manufacturing;

• Industrial and commercial use in foundry applications;

• Industrial and commercial use in specialty Department of Defense uses (oil analysis and water pipe repair);

• Commercial use in inks and ink removal products (based on printing);

• Commercial use in inks and ink removal products (based on photocopying);

• Commercial use for photographic film;

• Commercial use in mold cleaning, release and protectant products;

• Consumer use in cleaners and degreasers (other);

• Consumer use as a dry cleaning solvent;

• Consumer use in automotive care products (brake cleaner);

• Consumer use in automotive care products (parts cleaner);

• Consumer use in aerosol cleaner (vandalism mark and stain remover);

• Consumer use in non-aerosol cleaner ( e.g., marble and stone polish);

• Consumer use in lubricants and greases (cutting fluid);

• Consumer use in lubricants and greases (lubricants and penetrating oils);

• Consumer use in adhesives for arts and crafts (including industrial adhesive, arts and crafts adhesive, gun ammunition sealant);

• Consumer use in adhesives for arts and crafts (livestock grooming adhesive);

• Consumer use in adhesives for arts and crafts (column adhesive, caulk and sealant);

• Consumer use in solvent-based paints and coatings (outdoor water shield (liquid));

• Consumer use in solvent-based paints and coatings (coatings and primers (aerosol));

• Consumer use in solvent-based paints and coatings (rust primer and sealant (liquid));

• Consumer use in solvent-based paints and coatings (metallic overglaze);

• Consumer use in metal ( e.g., stainless steel) and stone polishes;

• Consumer use in inks and ink removal products;

• Consumer use in welding;

• Consumer use in mold cleaning, release and protectant products; and

• Disposal.

The following condition of use does not drive EPA's unreasonable risk determination for PCE:

• Distribution in commerce.

EPA is not making a condition of use-specific risk determination for this condition of use, is not issuing a final order under TSCA section 6(i)(1) for this condition of use and does not consider the revised risk determination for PCE to constitute a final agency action at this point in time.

Consistent with the statutory requirements of TSCA section 6(a), EPA will propose a risk management regulatory action to the extent necessary so that PCE no longer presents an unreasonable risk. EPA expects to focus its risk management action on the conditions of use that drive the unreasonable risk. However, it should be noted that, under TSCA section 6(a), EPA is not limited to regulating the specific activities found to drive unreasonable risk and may select from among a suite of risk management requirements in section 6(a) related to manufacture (including import), processing, distribution in commerce, commercial use, and disposal as part of its regulatory options to address the unreasonable risk. As a general example, EPA may regulate upstream activities ( e.g., processing, distribution in commerce) to address downstream activities ( e.g., consumer uses) driving unreasonable risk, even if the upstream activities do not drive the unreasonable risk.

EPA received a total of 20 unique public comments on the June 30, 2022, draft revised risk determination for PCE during the comment period that ended August 1, 2022. Commenters included trade organizations, industry stakeholders, environmental groups, and non-governmental health advocacy organizations. A separate document that summarizes all comments submitted and EPA's responses to those comments has been prepared and is available in the docket for this notice (Ref. 10).

EPA is finalizing the revised risk determination for the PCE risk evaluation pursuant to TSCA section 6(b) and consistent with Executive Order 13990, (“Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis”) and other Administration priorities (Refs. 3, 4, 5, and 6). EPA is revising specific aspects of the first ten TSCA existing chemical risk evaluations in order to ensure that the risk evaluations better align with TSCA's objective of protecting health and the environment. For the PCE risk evaluation, this includes: (1) Making the risk determination in this instance based on the whole chemical substance instead of by individual conditions of use and (2) Emphasizing that EPA does not rely on the assumed use of PPE when making the risk determination.

EPA is now finalizing the revised risk determination for the December 2020 PCE Risk Evaluation (Ref. 2) pursuant to TSCA section 6(b). Under the revised determination (Ref. 1), EPA concludes that PCE, as evaluated in the risk evaluation as a whole, presents an unreasonable risk of injury to health when evaluated under its conditions of use. This revision replaces the previous unreasonable risk determinations made for PCE by individual conditions of use, supersedes the determinations (and withdraws the associated order) of no unreasonable risk for the conditions of use identified in the TSCA section 6(i)(1) no unreasonable risk order, and clarifies the lack of reliance on assumed use of PPE as part of the risk determination.

These revisions do not alter any of the underlying technical or scientific information that informs the risk characterization, and as such the hazard, exposure, and risk characterization sections are not changed, except to statements about PPE assumptions in section 2.4.1.4 (Consideration of Engineering Controls and PPE) and section 4.2.2.2 (Occupational Inhalation Exposure Summary and PPE Use Determinations by OES). The discussion of the issues in this Notice and in the accompanying final revision to the risk determination supersede any conflicting statements in the prior executive summary, section 2.4.1.4 and section 4.2.2.2 from the December 2020 PCE Risk Evaluation (Ref. 2), and the response to comments document (Ref. 11).

The revised unreasonable risk determination for PCE includes additional explanation of how the risk evaluation characterizes the applicable OSHA requirements, or industry or sector best practices, and also clarifies that no additional analysis was done, and the risk determination is based on the risk characterization (section 4) of the December 2020 PCE Risk Evaluation (Ref. 2).

The risk determination (section 5 of the December 2020 PCE Risk Evaluation (Ref. 2)) was not part of the scope of the Science Advisory Committee on Chemicals (SACC) peer review of the PCE risk evaluation. Thus, consistent with that approach, EPA did not conduct peer review of the final revised unreasonable risk determination for the PCE risk evaluation because no technical or scientific changes were made to the hazard or exposure assessments or the risk characterization.

EPA is also issuing a new order to withdraw the TSCA section 6(i)(1) no unreasonable risk order issued in section 5.4.1 of the December 2020 PCE Risk Evaluation (Ref. 2). This final revised risk determination supersedes the condition of use-specific no unreasonable risk determinations in the December 2020 PCE Risk Evaluation (Ref. 2). The order contained in section 5.5 of the revised risk determination (Ref. 1) withdraws the TSCA section 6(i)(1) order contained in section 5.4.1 of the December 2020 PCE Risk Evaluation (Ref. 2). Consistent with the statutory requirements of section 6(a), the Agency will propose risk management action to address the unreasonable risk determined in the PCE risk evaluation.

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 .

Authority: 15 U.S.C. 2601 et seq.

This action provides information that is directed to the public in general.

This document lists the statements of findings made by EPA after review of submissions under TSCA section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. This document presents statements of findings made by EPA during the reporting period.

TSCA section 5(a)(3) requires EPA to review a submission under TSCA section 5(a) and make one of several specific findings pertaining to whether the substance may present unreasonable risk of injury to health or the environment. Among those potential findings is that the chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment per TSCA section 5(a)(3)(C).

TSCA section 5(g) requires EPA to publish in the Federal Register a statement of its findings after its review of a submission under TSCA section 5(a) when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to PMNs, MCANs, and SNUNs submitted to EPA under TSCA section 5.

Anyone who plans to manufacture (which includes import) a new chemical substance for a non-exempt commercial purpose and any manufacturer or processor wishing to engage in a use of a chemical substance designated by EPA as a significant new use must submit a notice to EPA at least 90 days before commencing manufacture of the new chemical substance or before engaging in the significant new use.

The submitter of a notice to EPA for which EPA has made a finding of “not likely to present an unreasonable risk of injury to health or the environment” may commence manufacture of the chemical substance or manufacture or processing for the significant new use notwithstanding any remaining portion of the applicable review period.

No.

In this unit, EPA provides the following information (to the extent that such information is not claimed as Confidential Business Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this period, EPA has made findings under TSCA section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment:

The following list provides the EPA case number assigned to the TSCA section 5(a) submission and the chemical identity (generic name if the specific name is claimed as CBI).

• J-22-0014, J-22-0015, Modified yeast, chromosomally and stably modified to improve fermentation performance (Generic Name).

To access EPA's decision document describing the basis of the “not likely to present an unreasonable risk” finding made by EPA under TSCA section 5(a)(3)(C), look up the specific case number at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/chemicals-determined-not-likely.

Authority: 15 U.S.C. 2601 et seq.

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

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

This action is issued under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136-136y.

EPA is removing the following twelve chemicals from the current list of inert ingredients approved for use in pesticide products:

None of these twelve chemicals are currently being used as an inert ingredient in a pesticide product per EPA records of currently registered pesticide products. Additionally, no products containing any of these 12 chemicals were identified during the public comment period. EPA is removing these chemicals from the inert ingredient list to prevent the introduction of these PFAS into pesticide formulations without additional EPA review. This is in line with EPA's strategic roadmap to address PFAS ( https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf ).

Once an inert ingredient is removed from the list, any proposed future use of the inert ingredient would need to be supported by data provided to and reviewed by the EPA as part of a new inert ingredient submission request. The type of data needed to evaluate a new inert ingredient may include, among others, studies to evaluate potential carcinogenicity, adverse reproductive effects, developmental toxicity, genotoxicity as well as environmental effects associated with any chemical substance that is persistent or bioaccumulative. Information regarding the inert ingredient approval process may be found at https://www.epa.gov/pesticide-registration/inert-ingredients-overview-and-guidance.

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2022-0542, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room and the OPP docket is (202) 566-1744. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets.

Most pesticide products contain substances in addition to the active ingredient(s) that are referred to as inert ingredients or sometimes as “other ingredients.” An inert ingredient generally is any substance (or group of similar substances) other than an active ingredient that is intentionally included in a pesticide product. Examples of inert ingredients include emulsifiers, solvents, carriers, aerosol propellants, fragrances, and dyes. Additional information about inert ingredients, including requirements, and guidance can be accessed at https://www.epa.gov/pesticide-registration/inert-ingredients-regulation. The InertFinder tool, which contains the list of currently approved inert ingredients, can be found at https://ordspub.epa.gov/ords/pesticides/f?p=INERTFINDER:1::::1::.

On September 13, 2022 (87 FR 56051; FRL-9985-01-OCSPP), EPA published for comment a proposal to remove 12 chemicals from the Agency's list of inert ingredients approved for use in pesticide products because they have been identified as PFAS and they are no longer used in pesticide products. In response to EPA's request for comments, no specific information regarding those 12 chemical substances or any products that may include them was provided to the Agency.

EPA received six public comments on the proposal. A summary of the comments and EPA's responses is presented in this unit.

1. Support for removal of PFAS inert ingredients: Five commenters expressed support for the removal of the 12 PFAS inert ingredients. However, some commenters also expressed concern for other remaining PFAS inert and active ingredients in pesticide products apart from the 12 chemicals being removed. EPA will continue to look closely at existing pesticide products to determine whether they contain PFAS. As the Agency's understanding of PFAS grows and evolves, EPA will continue to follow the science and adjust, as appropriate, to help ensure that pesticide formulations do not cause unreasonable adverse effects on human health or the environment. EPA will also consider various regulatory options to address any concerns identified.

2. Administrative decision to remove chemical substances: One commenter stated that FIFRA requires that the Agency decision to remove chemical substances from the approved inert ingredient list must be based on risk. FIFRA does not state a standard for approval of an inert ingredient, specifying only the fee category and review time. While the statute incorporates the risk of unreasonable adverse effects on the environment as one of the factors in granting a registration for an individual pesticide product under FIFRA section 3, no such criteria apply to approval of an inert ingredient. Addition of an inert ingredient to the approved inert list is a prerequisite to approval of applications for registration of specific pesticide formulations that contain the inert ingredient. Approval of a registration application does incorporate risk and considers risks resulting from the formulation of the pesticide product including its inert ingredients.

As of the date of this notice, EPA is removing the twelve chemicals listed here from the current list of inert ingredients approved for use in pesticide products. These twelve chemicals are for nonfood use only and there are no food residue considerations related to this action.

Authority: 7 U.S.C. 136 et seq.

FDA is announcing the approval of a product redeeming a rare pediatric disease priority review voucher. Under section 529 of the FD&C Act (21 U.S.C. 360ff), which was added by FDASIA, FDA will report the issuance of rare pediatric disease priority review vouchers and the approval of products for which a voucher was redeemed. FDA has determined that the supplemental application for TYVASO DPI (treprostinil), approved May 23, 2022, meets the redemption criteria.

For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further information about TYVASO DPI (treprostinil), approved May 23, 2022, go to the “Drugs@FDA” website at https://www.accessdata.fda.gov/scripts/cder/daf/.

Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D)) permits debarment of an individual from importing or offering for import any drug into the United States if FDA finds, as required by section 306(b)(3)(C) of the FD&C Act, that the individual has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance.

On March 15, 2022, Mr. Kempema was convicted, as defined in section 306(l)(1) of FD&C Act, in the U.S. District Court for Northern District of Iowa, when the court entered judgment against him for the offense of Introduction into Interstate Commerce of Misbranded Drugs with Intent to Defraud After Having Been Previously Convicted of an Offense under 21 U.S.C. 331 and 333 in violation of sections 301(a), 301(k), and 303(a)(2) of the FD&C Act (21 U.S.C. 331(a), 331(k), and 333(a)(2)). FDA's finding that debarment is appropriate is based on the felony conviction referenced herein. The factual basis for this conviction is as follows: As contained in the Information, filed on October 4, 2021, and in the Plea Agreement from Mr. Kempema's case, Mr. Kempema was previously convicted, on February 8, 2012, of one count of introducing and causing the introduction of misbranded drugs into interstate commerce, and causing the misbranding of drugs held for sale after shipment in interstate commerce with intent to defraud or mislead, in violation of sections 301(a), 301(k), and 303(a)(2) of the FD&C Act in U.S. v. David Kempema, No. 5:11-cr-04140-MWB (N.D. Iowa). In that case, between October 2009 and July 2011, Mr. Kempema ordered pills from India that contained the same active ingredients as Viagra and Cialis, but that had not been approved by FDA for sale in the United States. Mr. Kempema then sold the non-FDA approved pills to U.S. consumers as Viagra and Cialis.

Subsequently, from about February 2014 through about December 2018, Mr. Kempema was the owner and operator of Canned Ads, a business located in Iowa. During that time, he obtained Silditop, Aurogra, and Tadalista pills from India and/or Germany. Mr. Kempema found suppliers by searching the internet for generic Viagra and Cialis. He then purchased the drugs online from vendors overseas and received the products at the location of his business Canned Ads in Iowa. Both Silditop and Aurogra were new drugs that contained sildenafil, the active ingredient in Viagra, while Tadalista was a new drug that contained tadalafil, the active ingredient in Cialis. Silditop, Aurogra, and Tadalista had not been approved by FDA for sale or distribution in the United States. FDA approved drugs containing the active ingredients sildenafil and tadalafil are only available by prescription, and the labeling for those products includes numerous warnings, including a warning that those drugs can cause blood pressure to drop suddenly to an unsafe level if taken with certain other medications.

Mr. Kempema placed advertisements that made claims about male enhancement dietary supplements in men's restrooms in businesses in Iowa, in truck stops along the Interstate 29 corridor, and other locations. If a customer placed an order with Mr. Kempema for male enhancement dietary supplements, he would supply the customer with Silditop, Aurogra, and/or Tadalista. Mr. Kempema did not identify the drugs he sold as Silditop, Aurogra, and/or Tadalista. Instead, Mr. Kempema offered the drugs for sale under the names of other drugs, such as “All Natural Male.” Mr. Kempema shipped the drugs to customers both inside and outside of the State of Iowa. The labeling on the drugs he shipped customers did not contain adequate directions for use and Mr. Kempema dispensed these prescription drugs without the prescription of a practitioner licensed by law to administer the drugs. During the course of this offense, Mr. Kempema obtained and attempted to obtain at least 4,059 pills for resale.

An undercover FDA agent made 3 controlled purchases from Mr. Kempema over a period of time for a product Mr. Kempema characterized as a dietary supplement called “All Natural Male” which came in the form of tablets in a pack of 10 at a cost of $5 per tablet. During the first controlled purchase, the agent purchased $50 worth of tablets from Mr. Kempema, which he shipped to the agent. FDA testing later revealed that the tablets the undercover FDA agent purchased contained sildenafil, an undeclared erectile dysfunction drug. After the FDA undercover agent made the second controlled purchase, Mr. Kempema shipped the agent two 10-count blister packs of Silditop 100 Sildenafil Citrate tablets IP 100mg. The labeling for the products indicated they had been manufactured in India by Centurion Remedies PVT.LTD, for Healing Pharma, and FDA confirmed the products were not approved for sale or distribution in the United States. After the third controlled purchase, Mr. Kempema shipped the undercover FDA agent two 10-count blister packets with labeling that indicated the products were “Aurogra 100” Sildenafil Tablets 100mg. The labeling listed the manufacturer as “Aurochem Pharmaceuticals” of India, and FDA confirmed the products were not approved for sale or distribution in United States.

As a result of this conviction, FDA sent Mr. Kempema, by certified mail, on August 9, 2022, a notice proposing to debar him for a 5-year period from importing or offering for import any drug into the United States. The proposal was based on a finding under section 306(b)(3)(C) of the FD&C Act that Mr. Kempema's felony conviction under Federal law for Introduction into Interstate Commerce of Misbranded Drugs with Intent to Defraud After Having Been Previously Convicted of an Offense under sections 301(a), 301(k), and 303(a)(2) of the FD&C Act was for conduct relating to the importation into the United States of any drug or controlled substance because he illegally imported and introduced misbranded prescription drug products into interstate commerce. In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr. Kempema's offense and concluded that the offense warranted the imposition of a 5-year period of debarment.

The proposal informed Mr. Kempema of the proposed debarment and offered him an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Kempema received the proposal and notice of opportunity for a hearing on August 15, 2022. Mr. Kempema failed to request a hearing within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment (21 CFR part 12).

Therefore, the Assistant Commissioner, Office of Human and Animal Food Operations, under section 306(b)(3)(C) of the FD&C Act, under authority delegated to the Assistant Commissioner, finds that Mr. David J. Kempema has been convicted of a felony under Federal law for conduct relating to the importation into the United States of any drug or controlled substance. FDA finds that the offense should be accorded a debarment period of 5 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act.

As a result of the foregoing finding, Mr. Kempema is debarred for a period of 5 years from importing or offering for import any drug into the United States, effective (see DATES ). Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for import into the United States of any drug by, with the assistance of, or at the direction of Mr. Kempema is a prohibited act.

Any application by Mr. Kempema for termination of debarment under section 306(d)(1) of the FD&C Act should be identified with Docket No. FDA-2022-N-0521 and sent to the Dockets Management Staff (see ADDRESSES ). The public availability of information in these submissions is governed by 21 CFR 10.20(j).

Publicly available submissions will be placed in the docket and will be viewable at https://www.regulations.gov or at the Dockets Management Staff (see ADDRESSES ) between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

On October 14, 2022, the Agency submitted a proposed collection of information entitled “Targeted Mechanism of Action Presentations in Prescription Drug Promotion” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0908. The approval expires on November 30, 2025. A copy of the supporting statement for this information collection is available on the internet at https://www.reginfo.gov/public/do/PRAMain.

Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services and by the General Services Administration, FDA is announcing the renewal of the Endocrinologic and Metabolic Drugs Advisory Committee (the Committee). The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility.

The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of endocrine and metabolic disorders and makes appropriate recommendations to the Commissioner.

The Committee shall consist of a core of 11 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of endocrinology, metabolism, epidemiology or statistics, and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. Non-Federal members of this committee will serve as Special Government Employees, representatives, or Ex-Officio members. Federal members will serve as Regular Government Employees or Ex-Officios. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting representative member who is identified with industry interests. There may also be an alternate industry representative.

Further information regarding the most recent charter and other information can be found at https://www.fda.gov/advisory-committees/endocrinologic-and-metabolic-drugs-advisory-committee/endocrinologic-and-metabolic-drugs-advisory-committee-charter or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT ). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

This proposed information collection was previously published in the Federal Register on September 26, 2022, pages 58364-58365 (87 FR 58364) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Mental Health (NIMH), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

Proposed Collection Title: Autism Spectrum Disorder (ASD) Research Portfolio Analysis, NIMH, 0925-0682, expiration date 1/31/2023, EXTENSION, National Institute of Mental Health (NIMH), National Institutes of Health (NIH).

Need and Use of Information Collection: The purpose of the ASD research portfolio analysis is to collect research funding data from U.S. and international ASD research funders, to assist the Interagency Autism Coordinating Committee (IACC) in fulfilling the requirements of the Combating Autism Act, and to inform the committee and interested stakeholders of the funding landscape and current directions for ASD research. Specifically, these analyses will continue to examine the extent to which current funding and research topics align with the IACC Strategic Plan for ASD Research. The findings will help guide future funding priorities by outlining current gaps and opportunities in ASD research as well as serving to highlight annual activities and research progress.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 408.

We encourage you to participate in this study by submitting comments and related materials. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided.

A. Submitting Comments: If you submit comments to the online public docket, please include the docket number for this rulemaking (USCG-2022-0347), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. We accept anonymous comments.

To submit your comment online, go to http://www.regulations.gov, and insert “USCG-2022-0347” in the “search box.” Click “Search”. Then click “Comment Now.” We will consider all comments and material received during the comment period.

B. Public Meetings: The Coast Guard may hold public meeting(s) if there is sufficient public interest. You must submit a request for one on or before January 13, 2023. You may submit your request for a public meeting online via http://www.regulations.gov. Please explain why you believe a public meeting would be beneficial. If we determine that a public meeting would aid in the study, we will hold a meeting at a time and place announced by a later notice in the Federal Register .

C. Viewing Comments and Documents: To view the comments and documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, click on the “read comments” box, which will then become highlighted in blue. In the “Keyword” box insert “USCG-2022-0347” and click “Search.” Click the “Open Docket Folder” in the “Actions” column.

D. Privacy Act: We accept anonymous comments. All comments received will be posted without change to https://www.regulations.gov and will include any personal information you have provided. For more about privacy and submissions in response to this document, see DHS's Correspondence System of Records notice (84 FR 48645, September 26, 2018). Documents mentioned in this notice as being available in the docket, and all public comments, will be in our online docket at https://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted, or a final rule is published.

Fairway or shipping safety fairway means a lane or corridor in which no artificial island or fixed structure, whether temporary or permanent, will be permitted. See 33 CFR 166.105 (a).

International Entry and Departure Transit Areas means navigation routes followed by vessels coming to or departing from the United States or an international seaport. For these studies, international entry and departure transit areas will connect to recommend shipping safety fairways at the outer limit of the U.S. Exclusive Economic Zone (EEZ).

Port Approaches mean navigation routes followed by vessels entering or departing a seaport from or to a primary transit route. These studies will consider port approaches that connect seaports to recommended shipping safety fairways described in the Atlantic Coast Port Access Route Study (ACPARS).

The Coast Guard is beginning a series of new studies regarding port approaches and international entry and departure transit areas, to ports on the Atlantic Coast of South Carolina, Georgia, Florida, Commonwealth of Puerto Rico, and the U.S. Virgin Islands. These routes are critical links of a robust and effective Marine Transportation System (MTS) and integral to efficient movement between ports and shipping safety fairways along the Atlantic Coast.

Section 50251 of the IRA allows the Department of the Interior to grant leases, easements, and rights-of-way previously withdrawn in the Presidential memorandum entitled “Memorandum on the Withdrawal of Certain Areas of the United States Outer Continental Shelf from Leasing Disposition” and dated September 8, 2020; or the Presidential memorandum entitled “Presidential Determination on the Withdrawal of Certain Areas of the United States Outer Continental Shelf from Leasing Disposition” and dated September 25, 2020. Additionally, section 50251 of the IRA expanded the authority under the Outer Continental Shelf Lands Act to include waters adjacent to any territory of the United States, specifically the Commonwealth of Puerto Rico. These new studies are focused on routes between port approaches and international entry and departure transit areas that would potentially be impacted through the creation of new, renewable offshore energy projects, created as a result of the implementation of the IRA.

The Ports and Waterways Safety Act, (PWSA)(46 U.S.C. 70003(c)(1)), authorizes the Commandant of the Coast Guard to designate necessary fairways and traffic separations schemes (TSSs) to provide safe access routes for vessels proceeding to and from United States ports. The designation of fairways and TSSs recognizes the paramount right of navigation over all other uses in the designated areas.

Before establishing or adjusting fairways, 46 U.S.C. 70003(c)(1) requires the Coast Guard to study potential traffic density and assess the need for safe access routes for vessels. During this process, the Coast Guard considers the views of the maritime community, environmental groups, and other stakeholders to reconcile the need for safe access routes with reasonable waterway uses. See 46 U.S.C. 70003(c)(3).

An analysis of potential traffic density, involving vessels proceeding to and from a U.S. port, is referred to as a Port Access Route Study (PARS). Several PARS will examine ports along the Southeast Atlantic Coast of the U.S. and U.S. Territories that are economically significant, support military operations, or are critical to national defense, and related international entry and departure transit areas. In particular the PARS will study areas that are integral to the safe, efficient and unimpeded flow of commerce to/from major international shipping lanes. Similar to the ACPARS, this PARS will use Automatic Identification System (AIS) data and information from stakeholders to identify and verify customary navigation routes as well as potential conflicts involving alternative activities, such as wind energy generation and offshore mineral exploitation and exploration.

The Seventh Coast Guard District will conduct this PARS. The study will commence upon publication of this notice and may take 12 months or more to complete.

The study area is bounded by a line connecting the following geographic positions:

1. 33°51′7″ N 078°32′27″ W to;

2. 32°26′38″ N 075°55′34″ W to;

3. 25°24′28″ N 079°56′37″ W to;

4. 25°09′2″ N 080°00′15″ W to;

5. 24°53′1″ N 080°12′27″ W to;

6. 24°25′53″ N 081°03′18″ W to;

7. 24°14′49″ N 081°53′7″ W thence following an arc of 12nm around a center point of Loggerhead Key, FL to;

8. 24°25′7″ N 082°55′50″ W to;

9. 24°50′16″ N 082°55′29″ W to;

10. 25°03′31″ N 081°22′23″ W to;

11. 25°11′41″ N 081°08′51″ W thence following the coastline back to origin.

This area extends approximately 185 nautical miles seaward of the North Carolina/South Carolina Border then approximately follows the territorial sea from Miami around the Florida Keys. An illustration showing the study area is available in the docket where indicated under ADDRESSES . Additionally, the study area is available for viewing on the Navigation Center's website at: https://www.navcen.uscg.gov/port-access-route-study-reports.

The Coast Guard will analyze ports that are economically significant, that support military operations, or are strategic for national defense along the Southeast Atlantic Coast and U.S. Territory. This study includes but is not limited to:

These studies will analyze navigation routes to and from the ports identified above to their proposed fairways, as well as international routes to and from the United States. Current capabilities and planned improvements in these ports to handle maritime conveyances will be considered. Analyses will be conducted in accordance with Marine Planning to Operate and Maintain the Marine Transportation System (MTS) and Implement National Policy, COMDTINST 16003.2B, and coordinated by the cognizant District Commander. This instruction is available at https://media.defense.gov/2019/Jul/10/2002155400/-1/-1/0/CI_16003_2B.PDF. Notices of study will be published in the Federal Register to inform and solicit public comments for each PARS.

We will publish the results of the PARS in the Federal Register . It is possible that the study may validate the status quo (no fairways or routing measures) and conclude that no changes are necessary. It is also possible that the study may recommend one or more changes to address navigational safety and the efficiency of vessel traffic management. The recommendations may lead to future rulemakings or appropriate international agreements.

This notice is issued under authority of 46 U.S.C. 70003(c) and 5 U.S.C.552(a).

The Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (Stafford Act), authorizes grants to assist State, local, and Tribal governments and certain private non-profit entities with the response to and recovery from disasters, following Presidentially-declared major disasters and emergencies. 44 CFR part 206 specifies the information collections necessary to facilitate the provision of assistance under the Public Assistance (PA) Program. 44 CFR 206.202 describes the general application procedures for the PA Program.

Title: Public Assistance Program.

Type of Information Collection: Extension, with change, of a currently approved information collection.

OMB Number: 1660-0017.

FEMA Forms: FEMA Form FF-104-FY-22-233 Organization Profile, FEMA Form FF-104-FY-22-234, Recipient Incident Information; FEMA Form FF-104-FY-21-131 (formerly FF 009-0-49), Request for Public Assistance; FEMA Form FF-104-FY-22-235, Applicant Impact Survey; FEMA Form FF-104-FY-22-238, Pre-Approval Request; FEMA Form FF-104-FY-22-236, Impact List; FEMA Form FF-104-FY-22-239; Project Application for Debris Removal; FEMA Form FF-104-FY-22-240, Project Application for Emergency Protective Measures; FEMA Form FF-104-FY-22-242, Project Application for Infrastructure Restoration; FEMA Form FF-104-FY-22-243, Project Application for Building Code and Floodplain Administration and Enforcement; FEMA Form FF-104-FY-22-244, Project Application for Management Costs; FEMA Form FF-104-FY-22-245, Damage Information; FEMA Form FF-104-FY-22-241, Project Application for COVID-19; FEMA Form FF-104-FY-21-137 (formerly FF 009-0-123), Force Account Labor Summary Record; FEMA Form FF-104-FY-21-135 (formerly FF 009-0-128), Applicant's Benefits Calculation Worksheet; FEMA Form FF-104-FY-21-141 (formerly FF 009-0-127), Force Account Equipment Summary Record; FEMA Form FF-104-FY-21-138 (formerly FF 009-0-124), Materials Summary Record; FEMA Form FF-104-FY-21-139 (formerly FF 009-0-125), Rented Equipment Summary Record; FEMA Form FF-104-FY-21-140 (formerly FF 009-0-126), Contract Work Summary Record; FEMA Form FF-104-FY-22-237, Donated Labor Sign-in; FEMA Form FF-104-FY-21-132 (formerly FF 009-0-111), Quarterly Progress Reports; FEMA Form FF-104-FY-22-248, Time Extension; FEMA Form FF-104-FY-22-249, State Administrative Plan; FEMA Form FF- 104-FY-21-250, Tribal Administrative Plan; Request for Appeals or Arbitrations; Request for Arbitration resulting from Hurricanes Katrina or Rita; FEMA Template 104-FY-21-100, Equitable COVID-19 Response and Recovery: Vaccine Administration Information; FEMA Form FF-104-FY-22-246, Environmental and Historic Preservation Addendum; FEMA Form FF-104-FY-22-247, Hazard Mitigation Addendum; and FEMA Form FF-104-FY-21-145 (formerly FF 009-0-141), FAC-TRAX System.

Abstract: The information collected is required for the Public Assistance (PA) Program eligibility determinations, grants management, and compliance with other Federal laws and regulations. The Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), authorizes grants to assist State, Tribal, and local governments and certain private non-profit entities with the response to and recovery from disasters following Presidentially declared major disasters and emergencies.

Affected Public: State, local or Tribal government and certain private non-profit entities.

Estimated Number of Respondents: 1,505.

Estimated Number of Responses: 635,269.

Estimated Total Annual Burden Hours: 341,635.

Estimated Total Annual Respondent Cost: $19,801,167.

Estimated Respondents' Operation and Maintenance Costs: $0.

Estimated Respondents' Capital and Start-Up Costs: $0.

Estimated Total Annual Cost to the Federal Government: $1,957,204.

Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

The Build America, Buy America Act (“BABA” or “the Act”) was enacted on November 15, 2021, as part of the Infrastructure Investment and Jobs Act (“IIJA”) (Pub. L. 117-58). The Act establishes a domestic content procurement preference, the BAP, for Federal infrastructure programs. Section 70914(a) of the Act establishes that no later than 180 days after the date of enactment, HUD must ensure that none of the funds made available for infrastructure projects may be obligated by the Department unless it has taken steps to ensure that the iron, steel, manufactured products, and construction materials used in a project are produced in the United States. In section 70912, the Act further defines a project to include “the construction, alteration, maintenance, or repair of infrastructure in the United States” and includes within the definition of infrastructure those items traditionally included along with buildings and real property. Thus, beginning May 14, 2022, new awards of FFA by HUD through a program for infrastructure, and any of those newly obligated funds then obligated by the grantee, are covered under BABA provisions of the Act, 41 U.S.C. 8301 note, unless covered by a waiver.

Since the enactment of the Act, HUD has worked diligently to implement the BAP. Consistent with the requirements of section 70913 of the Act, HUD produced a report identifying and evaluating all of HUD's Federal Financial Assistance programs for compliance with the BAP on January 19, 2022, by Federal Register notice “Identification of Federal Financial Assistance Infrastructure Programs Subject to the Build America, Buy America Provisions of the Infrastructure Investment and Jobs Act” (87 FR 2894). In order to ensure orderly implementation of the BAP across HUD's programs, HUD published two general applicability waivers for HUD's programs on May 3, 2022. The first notice, “General Applicability Waiver of Build America, Buy America Provisions as Applied to Recipients of HUD Federal Financial Assistance” (87 FR 26219), extended the implementation date for the BAP until November 14, 2022, unless covered by a subsequent waiver. Thus, no funds obligated by HUD before November 14, 2022, are subject to the BAP. The second notice, “General Applicability Waiver of Build America, Buy America Provisions as Applied to Tribal Recipients of HUD Federal Financial Assistance” (87 FR 26221), extended the implementation date for the BAP for Federal Financial Assistance provided to Tribal recipients for a period of one year. Additionally, on June 1, 2022 (87 FR 33193) HUD published a Request for Information “Request for Information Relating to the Implementation of the Build America, Buy America Act” to gather additional information necessary to fully implement the BAP for HUD programs and to adequately prepare necessary Paperwork Reduction Act notices relating to such implementation.

Following the expiration of the “General Applicability Waiver of Build America, Buy America Provisions as Applied to Recipients of HUD Federal Financial Assistance” (87 FR 26219), HUD published two additional long-term public interest waivers of the application of the BAP in exigent circumstances and in connection with Small Grants and De Minimis expenditures. Additionally, HUD determined that it will fully implement the BAP for purposes of the purchase of iron and steel products used in infrastructure projects funded with Federal Financial Assistance provided by HUD through its CDBG formula grants obligated by HUD on or after November 15, 2022, unless such purchases are covered by another applicable waiver issued by HUD. Additional details on HUD's implementation of the BABA requirements can be found at https://www.hud.gov/program_offices/general_counsel/BABA .

Under section 70914(b), HUD and other Federal agencies have authority to waive the application of a domestic content procurement preference when (1) application of the preference would be contrary to the public interest, (2) the materials and products subject to the preference are not produced in the United States at a sufficient and reasonably available quantity or satisfactory quality, or (3) inclusion of domestically produced materials and products would increase the cost of the overall project by more than 25 percent. Section 70914(c) provides that a waiver under 70914(b) must be published by the agency with a detailed written explanation for the proposed determination and provide a public comment period of not less than 15 days.

The Office of Management and Budget's April 18, 2022 memorandum, “Initial Implementation Guidance on Application of Buy America Preference in Federal Financial Assistance Programs for Infrastructure” (“OMB Memorandum M-22-11”), i encourages agencies to consider ways to provide the assistance to funding recipients that is necessary and effective for the implementation of the BAP, including consideration of phased implementation of BAP where appropriate.

In Fiscal Year 2022, HUD grantees will receive more than $15 billion through the Department's programs where infrastructure is an eligible activity that may be subject to the BAP. For example, Community Development Block Grant (“CDBG”) funds may be used for infrastructure projects ( e.g., water and sewer improvements, street improvements, neighborhood facilities) or non-infrastructure uses ( e.g., senior services, youth services, operation of food banks, administrative and planning expenses). HUD estimates that 40 percent of CDBG funds awarded in 2021 ($1.4 billion of $3.5 billion total) were used on infrastructure projects where the BAP could apply.

As HUD's previous notices advised and as supported by several comments received during the comment period, many of HUD's programs may be subject to the BAP and have previously not required compliance with similar Buy America preferences. Because the potential application of BAP mandated by the Act is new to the majority of HUD's programs and Federal Financial Assistance (“FFA”), HUD is choosing to implement the BAP first with respect to all iron and steel products used in infrastructure projects funded with FFA provided by HUD through its CDBG formula grants on or after November 15, 2022. In order to focus on this implementation, HUD is waiving the application of the BAP in connection with all other FFA provided by HUD. This will provide an additional limited period to allow for further consideration of the most efficient methods of implementation of the BAP across the remaining HUD programs for construction materials and manufactured products more generally. This waiver advances BABA by reducing the administrative burden to potential assistance recipients where the costs of uncertainty in compliance with BABA could distract from the focus on the efficient and effective implementation of BABA in one of HUD's largest FFA programs and allows for broader phased implementation once further clarity and guidance on the implementation is received. Failure to provide recipients such flexibilities could delay the award for infrastructure projects as grantees and funding recipients must exert considerable effort in accounting for the sourcing for miscellaneous, low-cost construction materials without the benefit of complete guidance on the Act's requirements.

HUD believes that better coordination with HUD FFA recipients in the implementation of BABA will avoid unnecessary and undue hardship. Such a waiver will allow grantees and funding recipients to focus their efforts on such critical projects. Issuing this waiver is not an alternative to increasing domestic production. Rather this waiver will allow HUD to focus (particularly in the early phases of BABA implementation) on key products and critical supply chains where increased U.S. manufacturing can best advance our economic and national security. This waiver also allows grantees and funding recipients to continue with projects in connection with iron and steel products where Made in America requirements have long been contemplated—providing greater ease of implementation for HUD's CDBG formula grantees. Without this waiver, HUD grantee and funding recipient participation could be impacted, such as modification of current plans.

By this notice, HUD announces that it is waiving the application of the BAP for all FFA obligated by HUD on or after November 23, the effective date of this waiver, and on or before February 21, 2023, except for those funds utilized in connection with the purchase of iron or steel products in infrastructure projects funded by CDBG formula grants obligated by HUD on or after November 15, 2022. In addition, in the case of FFA obligated by HUD on or after November 15, 2022 but prior to the effective date of the final waiver, HUD is waiving the application of the BAP for all expenditures incurred on or after the date of the final waiver, except for those funds utilized in connection with the purchase of iron or steel products in infrastructure projects funded by CDBG formula grants obligated by HUD on or after November 15, 2022.

As HUD's previous notice advised and as supported by several comments received during the comment period for that waiver, many of the HUD's programs that may be subject to the BAP and have previously not required compliance with similar Buy America preferences. Because the potential application of BAP mandated by the Act is new to the majority of HUD's FFA programs, this waiver advances BABA by targeting the initial phased implementation to a well-developed industry in connection with infrastructure projects being undertaken by sophisticated CDBG formula grantees. HUD intends to focus specific attention to the full implementation of the BAP in connection with the use of iron and steel in infrastructure projects in other FFA programs utilizing HUD funds within this waiver period.

No funds obligated by HUD or the grantee/funding recipient during the period of the waiver that would be exempted from compliance with BAP as a result of the waiver will be required to apply the BAP.

As required under section 70914 of the Act, HUD solicited comment from the public on the public interest waiver announced in this notice on its website and then published the proposed waiver in the Federal Register . A total of 15 comments were received in response to the proposed waiver. HUD thoroughly reviewed and considered each of the comments in determining to move forward with the issuance of this waiver as published in this final notice. The comments were supportive of the orderly implementation of the BAP, but were varied in the commenters' recommendations as to how to best accomplish such implementation.

A few commenters expressed support for a waiver of broader scope, potentially excluding all affordable housing programs from requirements to apply the BAP. A similar number of commenters requested that HUD move more expeditiously to fully implement the BAP across all HUD FFA programs. HUD appreciates the comments from both perspectives, but believes that the strategic implementation of iron and steel purchase requirements of the BAP in connection with CDBG formula grants obligated by HUD on or after November 15, 2022, is an appropriate first step towards the appropriate implementation of the BAP. Such a measured step forward in implementation of the Act represents an appropriate balancing of the intent of the Act with the public interest in the continued efficiency and success of infrastructure projects funded through HUD's affordable housing and community development programs, the majority of which have not previously been subject to Buy America requirements to the extent of those included in the BAP. HUD therefore declines to alter the scope of the proposed phased implementation waiver at this time. HUD will continue to monitor the implementation of the BAP across its programs to ensure the most robust application possible in light of the important public interests discussed above.

Several proponents of the waiver requested that HUD provide guidance regarding the implementation of the BAP and extend this waiver until after the provision of such guidance. HUD appreciates these comments as well and will continue to work to develop robust guidance regarding the implementation of the BAP across its programs. HUD remains committed to reviewing its plans to provide for the effective and efficient implementation of the Act across its programs but is declining to extend the term of this waiver at this time.

No funds that have been obligated by HUD on or before November 14, 2022, or during the pendency of this waiver will require compliance with the BAP, with the exception of iron and steel products used in connection with infrastructure projects funded through CDBG formula grants obligated by HUD on or after November 15, 2022, or unless otherwise required by another FFA award. Where the BAP or other BABA requirements are made applicable to a project of a grantee or funding recipient by another Federal agency, those requirements are not waived by this waiver, nor is the grantee or funding recipient exempt from the application of those requirements in accordance with the requirements of the Federal Agency providing such Federal Financial Assistance.

Under OMB Memorandum M-22-11, agencies are expected to assess “whether a significant portion of any cost advantage of a foreign-sourced product is the result of the use of dumped steel, iron, or manufactured products or the use of injuriously subsidized steel, iron, or manufactured products” as appropriate before granting a public interest waiver. HUD's analysis has concluded that this assessment is not applicable to this waiver, as this waiver is not based in the cost of foreign-sourced products. HUD will perform additional market research during the waiver period to better understand the market and to limit the use of waivers caused by dumping of foreign-sourced products.

The Build America, Buy America Act (“BABA” or “the Act”) was enacted on November 15, 2021, as part of the Infrastructure Investment and Jobs Act (IIJA). Public Law 117-58. The Act establishes a domestic content procurement preference, the BAP, for Federal infrastructure programs. Section 70914(a) of the Act establishes that no later than 180 days after the date of enactment, HUD must ensure that none of the funds made available for infrastructure projects may be obligated by the Department unless it has taken steps to ensure that the iron, steel, manufactured products, and construction materials used in a project are produced in the United States. In section 70912, the Act further defines a project to include “the construction, alteration, maintenance, or repair of infrastructure in the United States” and includes within the definition of infrastructure those items traditionally included along with buildings and real property. Thus, starting May 14, 2022, new awards of FFA from a program for infrastructure, and any of those funds obligated by the grantee, are covered under BABA provisions of the Act, 41 U.S.C. 8301 note, unless covered by a waiver.

Since the enactment of the Act, HUD has worked diligently to implement the BAP. Consistent with the requirements of section 70913 of the Act, HUD produced a report identifying and evaluating all of HUD's FFA programs for compliance with the BAP on January 19, 2022, through Federal Register notice “Identification of Federal Financial Assistance Infrastructure Programs Subject to the Build America, Buy America Provisions of the Infrastructure Investment and Jobs Act.” (87 FR 2894) In order to ensure orderly implementation of the BAP across HUD's programs, HUD published two general applicability waivers for HUD's programs on May 3, 2022. The first notice, “General Applicability Waiver of Build America, Buy America Provisions as Applied to Recipients of HUD Federal Financial Assistance” (87 FR 26219), extended the implementation date for the BAP until November 14, 2022, unless covered by a subsequent waiver. Thus, no funds obligated by HUD before November 14, 2022, are subject to the BAP. The second notice, “General Applicability Waiver of Build America, Buy America Provisions as Applied to Tribal Recipients of HUD Federal Financial Assistance” (87 FR 26221), extended the implementation date for the BAP for Federal Financial Assistance (“FFA”) provided to Tribal recipients for a period of one year. HUD published a notice proposing the waiver that is being finalized through this notice on its website on October 31, 2022, and via the Federal Register . Additional details on HUD's implementation of the BABA requirements can be found at https://www.hud.gov/programoffices/generalcounsel/BABA.

Under section 70914(b), HUD has authority to waive the application of a domestic content procurement preference when (1) application of the preference would be contrary to the public interest, (2) the materials and products subject to the preference are not produced in the United States at a sufficient and reasonably available quantity or satisfactory quality, or (3) inclusion of domestically produced materials and products would increase the cost of completing the infrastructure project by more than 25 percent. Section 70914(c) provides that a waiver under 70914(b) must be published by the agency with a detailed written explanation for the proposed determination and provide a public comment period of not less than 15 days.

The Office of Management and Budget's April 18, 2022, memorandum, “Initial Implementation Guidance on Application of Buy America Preference in Federal Financial Assistance Programs for Infrastructure” (M-22-11) encourages agencies to consider whether it is in the public interest to waive application of a BAP to awards below the Simplified acquisition threshold. HUD is issuing this waiver not as an alternative to increasing domestic production, but as an important tool to implement the Buy American provisions in the most efficient manner. HUD understands that advancing Made in America objectives is a continuous effort. HUD plans to move forward to implement the new requirements in a way that maximizes coordination and collaboration to support long-term investments in domestic production.

Through this notice, HUD has waived the application of the BAP for infrastructure projects whose total cost (including HUD funding and funding from any other source) is an amount equal to or less than the 2 CFR 200.1 Simplified acquisition threshold, which is currently $250,000. HUD has also waived the application of the BAP for all Small Grants of Federal Financial Assistance provided by HUD that are equal to or below the 2 CFR 200.1 Simplified acquisition threshold, which is currently $250,000. However, if FFA provided by HUD is combined with other FFA from another Federal agency, and the total amount of FFA in a single project is greater than the Simplified acquisition threshold, currently $250,000, then the waiver shall not apply to the FFA provided by HUD. HUD has also waived the application of the BAP for a De Minimis portion of an infrastructure project, meaning a cumulative total of no more than 5 percent of the total cost of the iron, steel, manufactured products, and construction materials used in and incorporated into the infrastructure project, up to a maximum of $1 million.

For purposes of the Act, an infrastructure project involves the undertaking of any “construction, alteration, maintenance, or repair” of “infrastructure,” which includes, among other things, the “structures, facilities and equipment” of “buildings and real property.”

In accordance with the Act, HUD has found that such De Minimis and Small Grants waivers are in the public interest. Such waivers will allow HUD, grantees and funding recipients to focus their efforts on such critical projects. Issuing the waivers is not an alternative to increasing domestic production. The waivers are in the interest of efficiency, to ease burdens for HUD grantees and funding recipients, and will also allow HUD to focus, particularly in the early phases of BABA implementation, on key products, and critical supply chains where increased U.S. manufacturing can best advance our economic and national security. These waivers will allow HUD grantees and funding recipients to continue with projects. Without these waivers, HUD grantee and funding recipient participation could be impacted, such as modification of current plans.

HUD is issuing this waiver to facilitate the effective implementation of the BAP and will therefore not permit the artificial subdivision of infrastructure projects to fit within the scope of this waiver of the BAP. Thus, for purposes of this waiver, HUD will evaluate the total cost of the infrastructure project as it would for purposes of the review contemplated under 24 CFR part 58, i.e., by defining the scope consistent with 24 CFR 58.2(a)(4), as “the activity, or a group of integrally related activities, designed by the recipient to accomplish, in whole or in part, a specific objective.” HUD believes its grantees and recipients of FFA that will be used for infrastructure projects are familiar with this regulation and understand the proper application of the concept in connection with their activities, or as otherwise defined by HUD in a notice. However, in connection with the public housing program, evaluation of certain maintenance and repair activities within the definition of infrastructure projects under the Act is not appropriate using this standard. Therefore, for the purposes of determining the applicability of this waiver in connection with the maintenance and repair of public housing, HUD will evaluate the infrastructure project as including the single relevant procurement contract for such maintenance or repairs, or, where applicable, the collection of procurements focused on the same specific objective ( e.g., construction of a resident service space) or limited scope of work ( e.g., lead based paint abatement).

In fiscal year 2022, HUD grantees will receive more than $15 billion through the Department's programs where infrastructure is an eligible activity and may be subject to the BAP. For example, Community Development Block Grant (“CDBG”) funds may be used for infrastructure projects ( e.g., water and sewer improvements, street improvements, neighborhood facilities) or non-infrastructure uses ( e.g., senior services, youth services, operation of food banks, administrative and planning expenses). HUD estimates that 40 percent of CDBG funds awarded in 2021 ($1.4 billion of $3.5 billion total) were used on infrastructure projects where the BAP could apply.

As HUD's initial waivers advised and as supported by several comments received during the comment period on those waivers, many of HUD's programs may be subject to the BAP and have previously not required compliance with similar Buy American preferences. Because the potential application of BAP mandated by the Act is new to the majority of HUD's programs and FFA, this waiver advances BABA by reducing the administrative burden to potential assistance recipients where the costs of compliance with BABA could distract from the focus on higher value BABA compliant items. Failure to provide recipients such flexibilities could delay the award for infrastructure projects as grantees and funding recipients must exert considerable effort accounting for the sourcing for miscellaneous, low-cost items. Moreover, HUD does not believe the waiver of the BAP for such awards will undermine the full and robust implementation of the Act or the ability of the agency to support the purposes behind the Act.

HUD expects to review this waiver every five years from the effective date of this waiver or more often as appropriate. No funds obligated by HUD or the grantee/funding recipient during the period of the waiver that are exempted from compliance with BAP as a result of the waiver will be required to apply the BAP.

As required under section 70914 of the Act, HUD solicited comment from the public on the public interest waiver announced in this notice on its website and then published the proposed waiver in the Federal Register . A total of 14 comments were received in response to the proposed waiver. HUD thoroughly reviewed and considered each of the comments in determining to move forward with the issuance of this waiver as published in this final notice. The comments generally favored a De Minimis and Small Dollar waiver as proposed.

A few commenters expressed support for a broader scope waiver, including requesting higher limits for a Small Grants exclusion, a higher percentage exclusion on portions of infrastructure projects, and a higher cap on the total cost under the De Minimis waiver. A similar number of commenters requested that the limits be lowered to afford more opportunities for the application of the BAP. HUD appreciates the comments from both perspectives, but believes that, as an initial matter, the limits proposed in the initial waiver are set at the appropriate levels to balance the intent of the Act with the public interest in the continued efficiency and success of infrastructure projects funded through HUD's affordable housing and community development programs. HUD declines to make changes to the amounts represented by these limits at this time, but is clarifying that all FFA, whether received by HUD or from another Federal source, in connection with infrastructure projects must be used to calculate the total, cumulative FFA in a single project to determine the applicability of a Small Grants waiver. HUD will continue to monitor the implementation of the BAP across its programs to ensure the most robust application possible in light of the important public interests discussed above.

Several proponents of the waiver requested that HUD provide greater clarity regarding the implementation of the BAP and the appropriate application of this waiver. HUD appreciates these comments and will continue to work to develop robust guidance regarding the implementation of the BAP across its programs. HUD remains committed to reviewing the waivers it issues every five years or more often if necessary and appropriate.

A few comments were received from manufacturers and trade organizations that opposed portions of the proposed waiver because they would prefer a more narrowly tailored waiver, if a waiver is issued at all. These commenters expressed confusion over the reference to Minor Components in the proposed waiver. HUD agrees that use of the term Minor Components did not accurately reflect the waiver HUD was proposing. As a result, the waiver issued by HUD and announced via this final notice deletes all references to Minor Components and instead focuses on the true intent of the waiver—coverage for small grants and a De Minimis waiver.

Additionally, several of the opponents expressed concern that the waiver could give rise to a loophole to avoid compliance with the BAP. HUD appreciates the comments but believes that the waiver is sufficiently narrowly tailored with protections in place to avoid artificial manipulation of project size and that the risk of abuse is outweighed by the need to provide this important flexibility for Small Grants and the De Minimis portions of larger infrastructure projects. HUD expects the future guidance and technical assistance it provides to grantees regarding the implementation of the Act to further address any concerns that the scope or applicability of this waiver will be misconstrued by grantees. HUD will not allow the use of the waiver in any artificial or contrived circumstances designed to avoid the proper application of the BAP requirements. HUD has therefore declined to modify the waiver at this time, beyond the clarification of the use of the cumulative total of all FFA funding the infrastructure project in determining application of this waiver. As previously indicated, HUD will continue to monitor the usage of the waiver so it may swiftly address any potential confusion concerning the proper application of the waiver.

The complexities of applying the BAP in connection with Small Grants and De Minimis portions of projects are such that the Agency maintains, for the reasons outlined herein, the public interest necessitates this waiver of the BAP. HUD will continue its work to assess compliance alternatives and options best suited to enable grantees and funding recipients to more efficiently and effectively implement the BAP in connection with Small Grants and De Minimis portions of infrastructure projects and will reevaluate this waiver in five years or sooner as appropriate. Additionally, HUD will continue to assess the need for and provide additional guidance for funding recipients and grantees to ensure the appropriate implementation of the BAP in its programs. At this time, however, HUD has issued this Small Grant and De Minimis waiver with the minimal substantive changes described herein and with other minor, inconsequential grammatical revisions.

Where the BAP or other BABA requirements are made applicable to projects of a grantee or funding recipient by another Federal agency, the grantee or funding recipient may not rely on this waiver as a waiver of any requirement imposed by the other Federal agency for the projects, nor is the grantee or funding recipient exempt from the application of those requirements in accordance with the requirements of the Federal agency providing such FFA.

Under OMB Memorandum M-22-11, “Memorandum for Heads of Executive Departments and Agencies,” published on April 18, 2022, agencies are expected to assess “whether a significant portion of any cost advantage of a foreign-sourced product is the result of the use of dumped steel, iron, or manufactured products or the use of injuriously subsidized steel, iron, or manufactured products” as appropriate before granting a public interest waiver. i HUD's analysis has concluded that this assessment is not applicable to this waiver, as this waiver is not based in the cost of foreign-sourced products. HUD will perform additional market research during the duration of the waiver to better understand the market to limit the use of waivers caused by dumping of foreign-sourced products.

The Build America, Buy America Act (“BABA” or “the Act”) was enacted on November 15, 2021, as part of the Infrastructure Investment and Jobs Act (IIJA). Public Law 117-58. The Act establishes a domestic content procurement preference, the BAP, for Federal infrastructure programs. Section 70914(a) of the Act establishes that no later than 180 days after the date of enactment, HUD must ensure that none of the funds made available for infrastructure projects may be obligated by the Department unless it has taken steps to ensure that the iron, steel, manufactured products, and construction materials used in a project are produced in the United States. In section 70912, the Act further defines a project to include “the construction, alteration, maintenance, or repair of infrastructure in the United States” and includes within the definition of infrastructure those items traditionally included along with buildings and real property. Thus, starting May 14, 2022, new awards of FFA from a program for infrastructure, and any of those funds obligated by the grantee, are covered under the BABA provisions of the Act, 41 U.S.C. 8301 note, unless covered by a waiver. Section 70912(4)(B) of the Act specifically exempts from the term Federal Financial Assistance certain assistance authorized under certain sections of the Robert T. Stafford Disaster Relief and Emergency Assistance Act or pre and post disaster or emergency response expenditures.

Since the enactment of the Act, HUD has worked diligently to implement the BAP. Consistent with the requirements of section 70913 of the Act, HUD produced a report identifying and evaluating all of HUD's FFA programs for compliance with the BAP on January 19, 2022, by Federal Register notice “Identification of Federal Financial Assistance Infrastructure Programs Subject to the Build America, Buy America Provisions of the Infrastructure Investment and Jobs Act” (87 FR 2894). In order to ensure orderly implementation of the BAP across HUD's programs, HUD published two general applicability waivers for HUD's programs on May 3, 2022. The first notice, “General Applicability Waiver of Build America, Buy America Provisions as Applied to Recipients of HUD Federal Financial Assistance” (87 FR 26219), extended the implementation date for the BAP until November 14, 2022, unless covered by a subsequent waiver. Thus, no funds obligated by HUD before November 14, 2022, are subject to the BAP. The second notice, “General Applicability Waiver of Build America, Buy America Provisions as Applied to Tribal Recipients of HUD Federal Financial Assistance” (87 FR 26221), extended the implementation date for the BAP for Federal Financial Assistance provided to Tribal recipients for a period of one year. HUD published a notice proposing the waiver that is being finalized through this notice on its website on October 31, 2022, and via the Federal Register . Additional details on HUD's implementation of the BABA requirements can be found at https://www.hud.gov/program_offices/general_counsel/BABA.

Under section 70914(b), HUD has authority to waive the application of a domestic content procurement preference when (1) application of the preference would be contrary to the public interest, (2) the materials and products subject to the preference are not produced in the United States at a sufficient and reasonably available quantity or satisfactory quality, or (3) inclusion of domestically produced materials and products would increase the cost of the overall project by more than 25 percent. Section 70914(c) provides that a waiver under 70914(b) must be published by the agency with a detailed written explanation for the proposed determination and provide a public comment period of not less than 15 days.

HUD is issuing this waiver not as an alternative to increasing domestic production, but as an important tool to implement the Buy American provisions in the most efficient manner. HUD understands that advancing Made in America objectives is a continuous effort. HUD plans to move forward to implement the new requirements in a way that maximizes coordination and collaboration to support long-term investments in domestic production.

HUD recognizes that there are exigent circumstances, particularly with respect to the conduct of maintenance and other rehabilitation and repair activities in connection with affordable housing and community development projects, that warrant the exclusion from the application of the BAP in the public interest. Specifically, where an award for FFA is being utilized to repair or conduct maintenance of infrastructure within the meaning of the Act in exigent circumstances, the ability to quickly respond and address the need is critical to ensuring the protection of life, safety and property of residents and community members. This ability to immediately respond to such situations could be compromised if the grantee or recipient is required to navigate the complex BAP requirements for such an activity in the midst of the exigent circumstances. i Such a waiver will allow HUD grantees and funding recipients to focus their efforts on such critical projects. Issuing this waiver is not an alternative to increasing domestic production. The waiver is in the interest of efficiency, to ease burdens for grantees and recipients, avoid unnecessary costs, and avoid delays to projects that are critical and time sensitive. The waiver will also allow HUD to focus, particularly in the early phases of BABA implementation, on key products and critical supply chains where increased U.S. manufacturing can best advance HUD's economic and national security. This waiver will also allow recipients to continue with projects. Without this waiver, delays may occur to critical activities to protect life, safety, and property, which may negatively impact the most vulnerable Americans HUD seeks to serve.

For example, if a public housing development is damaged by a boiler malfunction in the middle of the winter, the need to repair the damaged structure and replace the boiler is of immediate concern in protecting the life, safety, and property of the residents of that public housing development. Additionally, for example, if an emergency or fire exit door is damaged and becomes unusable, the need to repair the exit door is of immediate concern to protecting the life, safety and property of the residents of that public housing development. Included within the scope of exigent circumstances are the remediation of defects impacting housing quality standards that existing HUD policy requires to be completed within 30 days or less. The potential consequences and impact of incidents meeting these standards can endanger the life, safety or property of residents and the community, and necessitate urgent action to remediate the issue. Thus, for purposes of this waiver, HUD will consider exigent circumstances to include circumstances where undertaking the BAP-covered infrastructure project without delay is necessary to protect life, safety or provide necessary security to residents or community members, or to prevent the destruction of property. The waiver of BAP will apply provided such remediation is carried out within the time period required by HUD policy.

In fiscal year 2022, HUD grantees will receive more than $15 billion through the Department's programs where infrastructure is an eligible activity and may be subject to the BAP. For example, Community Development Block Grant (“CDBG”) funds may be used for infrastructure projects ( e.g., water and sewer improvements, street improvements, neighborhood facilities) or non-infrastructure uses ( e.g., senior services, youth services, operation of food banks, administrative and planning expenses). HUD estimates that 40 percent of CDBG funds awarded in 2021 ($1.4 billion of $3.5 billion total) were used on infrastructure projects where the BAP could apply. HUD does not currently track funds used on infrastructure projects for an exigent circumstance, but estimates that in an average year, less than 1 percent of annual CDBG funds are used for urgent needs activities.

HUD believes that full compliance with the BAP in exigent circumstances will create undue hardship due to the anticipated burdensome delays to ensure compliance with the BAP and, as noted, could jeopardize the life, health and safety of residents and community members unnecessarily for funds being utilized in exigent circumstances. As a result, HUD has determined that it is not in the public interest to impose the BAP on projects completing covered infrastructure activities in exigent circumstances.

HUD expects to review this waiver every five years from the effective date of this waiver or more often as appropriate. Funds obligated by HUD during the time period this waiver is effective will not be required to apply the BAP when funds are expended by the grantee or funding recipient in connection with exigent circumstances as described in this waiver.

As required under section 70914 of the Act, HUD solicited comment from the public on the public interest waiver announced in this notice on its website and then published the proposed waiver in the Federal Register . A total of 11 comments were received in response to the proposed waiver. HUD thoroughly reviewed and considered each of the comments in determining to move forward with the issuance of this waiver as published in this final notice. The comments generally favored an exigent circumstances waiver as proposed.

A few commenters expressed support for a broader waiver and greater deference to the determinations of grantees in terms of projects that fall within the scope of exigent circumstances. Several proponents of the waiver requested that HUD provide greater clarity regarding the implementation of the BAP and the appropriate application of this waiver. HUD appreciates these comments and will continue to work to develop robust guidance regarding the implementation of the BAP across its programs. HUD remains committed to reviewing the waivers it issues every five years or more often if necessary and appropriate.

A few comments were received from manufacturers and trade organizations that opposed portions of the proposed waiver because they would prefer a more narrowly tailored waiver, if a waiver is issued at all. Several of these comments expressed concern that the waiver would give rise to a loophole to avoid compliance with the BAP. HUD appreciates the comments but believes that the waiver is sufficiently narrowly tailored to specific actions necessary to protect life, safety and property from imminent threats that the risk of abuse is outweighed by the need to provide flexibility to act swiftly in exigent circumstances.

HUD expects the future guidance and technical assistance it provides to grantees regarding the implementation of the Act to address any concerns that the scope or applicability of this waiver will be misconstrued by grantees. HUD will not allow the use of the waiver in any artificial or contrived circumstances designed to avoid the proper application of the BAP requirements. HUD has therefore declined to modify the waiver at this time, but will continue to monitor the usage of the waiver so it may swiftly address any future confusion over the proper application of the waiver. The complexities of applying the BAP in exigent circumstances where there is a risk posed to life, safety, or property are such that HUD maintains, for the reasons outlined herein, the public interest necessitates this waiver of the BAP.

HUD will continue its work to assess compliance alternatives and options best suited to enable grantees and funding recipients to swiftly address projects necessitated by exigent circumstances and will reevaluate this waiver in five years or sooner as appropriate. Additionally, HUD will continue to assess the need for and provide additional guidance for funding recipients and grantees to ensure the appropriate implementation of the BAP in its programs. At this time, HUD is issuing, without substantive change other than minor, inconsequential grammatical revisions this Exigent Circumstances Waiver via this final notice.

Where the BAP or other BABA requirements are made applicable to projects of a grantee or funding recipient by another Federal agency, the grantee or funding recipient may not rely on this waiver as a waiver of any requirement imposed by the other Federal agency for the projects, nor is the grantee or funding recipient exempt from the application of those requirements in accordance with the requirements of the Federal agency providing such Federal Financial Assistance.

Under OMB Memorandum M-22-11, “Memorandum for Heads of Executive Departments and Agencies,” published on April 18, 2022, agencies are expected to assess “whether a significant portion of any cost advantage of a foreign-sourced product is the result of the use of dumped steel, iron, or manufactured products or the use of injuriously subsidized steel, iron, or manufactured products” as appropriate before granting a public interest waiver. ii HUD's analysis has concluded that this assessment is not applicable to this waiver, as this waiver is not based in the cost of foreign-sourced products. HUD will perform additional market research during the duration of the waiver to better understand the market to limit the use of waivers caused by dumping of foreign-sourced products.

In accordance with the Federal Advisory Committee Act, the BIE is announcing the Advisory Board will hold its next meeting in-person and online. The Advisory Board was established under the Individuals with Disabilities Act of 2004 (20 U.S.C. 1400 et seq. ) to advise the Secretary of the Interior, through the Assistant Secretary-Indian Affairs, on the needs of Indian children with disabilities. All meetings, including virtual sessions, are open to the public in their entirety.

The following agenda items will be for the January 19, 2023 and January 20, 2023 meeting. The reports are regarding special education topics from the:

• BIE Central Office.

• BIE Associate Deputy Director regions regarding Special Education updates for Bureau Operated Schools, Navajo Schools, and Tribally Controlled Schools.

• BIE's State Performance Plan/Annual Performance Report (SPP/APR)—Indicator 8, Parent Involvement target setting.

• Haskell Indian Nations University and the Southwest Indian Polytechnic Institute—to address challenges of preparing educators for schools serving significant numbers of Native American students in Bureau funded schools.

• BIE Human Resource Department—status of current vacant educator positions and turnover as compared to last year for educator positions at the school level, and how the BIE recruits and retains personnel to fill position vacancies.

• BIE/Division of Performance and Accountability (DPA)/Special Education Program Updates.

• Four Public Commenting Sessions will be provided during both meeting days.

○ On Thursday, January 19, 2022 two sessions (15 minutes each) will be provided, 11:15 a.m. to 11:30 a.m. MST and 1 p.m. to 1:15 p.m. MST. Public comments can be provided via webinar or telephone conference call. Please use the online access codes as listed below.

○ On Friday, January 20, 2022 two sessions (15 minutes each) will be provided, 11:15 a.m. to 11:30 a.m. MST and 1 p.m. to 1:15 p.m. MST. Public comments can be provided during the meeting or telephone conference call. Please register for each meeting day to obtain the online meeting access codes as listed below.

○ Public comments can also be emailed to the DFO at Jennifer.davis@bie.edu; or faxed to (602) 265-0293 Attention: Jennifer Davis, DFO; or mailed or hand delivered to the Bureau of Indian Education, Attention: Jennifer Davis, DFO, 2600 N Central Ave., 12th Floor, Suite 250, Phoenix, Arizona 85004.

• To attend the January 19, 2023, board meeting, please register at https://www.zoomgov.com/meeting/register/vJItd-uorzwpHX0JScKwuiQ5-_fhSLVprEg.

• To attend the January 20, 2023, board meeting, please register at https://www.zoomgov.com/meeting/register/vJIsceCvqDsvGeULtmV6M2Lp47zKlRfHfRY.

Authority: 5 U.S.C. Appendix 5; 20 U.S.C. 1400 et seq.

On November 4, 2022, the Commission determined that it should proceed to full reviews in the subject five-year reviews pursuant to section 751(c) of the Tariff Act of 1930 (19 U.S.C. 1675(c)). 1 The Commission found that both the domestic and respondent interested party group responses from Mexico and South Korea to its notice of institution (87 FR 47001, August 1, 2022) were adequate, and determined to conduct full reviews of the orders on imports from Mexico and South Korea. The Commission also found that the respondent interested party group responses from Brazil and Poland were inadequate but determined to conduct full reviews of the orders on imports from those countries in order to promote administrative efficiency in light of its determinations to conduct full reviews of the orders with respect to Mexico and South Korea. A record of the Commissioners' votes will be available from the Office of the Secretary and at the Commission's website.

Authority: These reviews are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.62 of the Commission's rules.