On August 13, 2018, the President signed Public Law 115-232, the National Defense Authorization Act (NDAA) for Fiscal Year 2019 ( i.e., the Act). Section 1108 of the Act established a new hiring authority, codified at 5 U.S.C. 3116, for appointing certain post-secondary students to certain positions in the competitive service. This section also directs OPM to issue regulations to implement this authority. Section 1108 of the Act also established a hiring authority for appointments of college graduates. OPM is issuing regulations to implement the hiring authority for college graduates in a separate notification. (New section 3116 was amended by Pub. L. 116-92, the NDAA for Fiscal Year 2020, which modified 5 U.S.C. 3116(d)(1).)

OPM is issuing interim regulations, with an opportunity for comments, that will create a new subpart I of part 316, title 5, Code of Federal Regulations (CFR), and revise part 330 Recruitment, Selection, and Placement (General).

The interim rule for post-secondary students allows agencies to make time-limited appointments per the statute of eligible individuals directly into the competitive service, without regard to 5 U.S.C. 3309-3319 and 3330. Readers should note that this new hiring authority is separate and distinct from the programs authorized under the Executive Order 13562 (establishing the Pathways Programs, which provide for appointments in the excepted service for Interns, Recent Graduates, and Presidential Management Fellows as described in 5 CFR part 362).

When using this authority, agencies must provide public notification and follow merit system principles, in accordance with Section 1108, as codified at 5 U.S.C. 3116 (The merit system principles are codified at 5 U.S.C. 2301). Because section 1108 of the Act waives the requirement for OPM to post a vacancy to be filled under this authority that would otherwise apply (5 U.S.C. 3330), agencies are not required to use www.USAJOBS.gov ( i.e., USAJOBS) to provide notice of these vacancies. Agencies may wish to use USAJOBS, nevertheless, in light of that system's ability to assist with the requirement to collect demographic information. Agencies must advertise positions in a manner that provides for “diverse and qualified applicants,” 5 U.S.C. 3116(c)(2)(B), “ensure[s] that potential applicants have appropriate information relevant to the position being filled,” id. at 3116(c)(2)(C), and adhere[s] to merit system principles,” id. at 3116(c)(2)(A). As indicated in 5 U.S.C. 3116, agencies must determine whether an applicant meets the eligibility requirements for the Post-Secondary Students hiring authority before giving that applicant further consideration. Agencies must then assess whether an eligible applicant meets the government-wide ( i.e., OPM-established) or OPM-approved agency-specific minimum qualification standard for the position being filled.

Agencies are not required to provide selection priority to eligible and qualified applicants entitled to selection priority in accordance with 5 CFR part 330, subparts F and G, pertaining to Agency Career Transition Assistance Plans (CTAP) and Interagency Career Transition Assistance Plans (ICTAP). OPM has revised these subparts to include exceptions to these provisions when appointments are made using this Post-Secondary Student authority.

OPM has revised 5 CFR part 315, subpart G, to provide for non-competitive conversion of Post-Secondary students.

Section 1108 of the Act also allows agencies to make appointments without regard to any provision of 5 U.S.C. 3309 through 3319. An agency may select any eligible individual who meets each minimum qualification standard, without regard to the application of veterans' preference, but, in accordance with new section 3116(c)(2)(A), must adhere to merit system principles, 5 U.S.C. 2301, in so doing. Agencies may appoint individuals under this authority to time-limited appointments in the competitive service at the grade levels specified in 5 U.S.C. 3116.

OPM is adding a new § 316.901 Agency authority establishing that an agency may noncompetitively appoint an eligible and qualified post-secondary student to any position in the competitive service, on a time-limited basis, at the General Schedule (GS) 11 level or below (or equivalent). An agency may appoint individuals, on a time-limited basis, to a temporary appointment (for an initial period not to exceed 1 year), or a term appointment (for an initial period expected to last more than 1 year but less than 4 years), to coincide with the individual's academic curriculum and calendar. In either case, an agency may extend an initial appointment for a period that will allow the student to complete his or her degree requirements, provided the criteria for the student appointment continue to be met. Appointments made under this authority, however, are nevertheless subject to the time limitations in 5 CFR part 316, unless the agency obtains OPM's permission to extend in individual cases. For example, an agency hires a student who is expected to complete his or her degree within 8 months. The agency would place the student on a temporary appointment ( i.e., the initial appointment is expected to last for up to 1 year). If the student takes longer than expected to complete his or her degree, the agency may extend the initial appointment for up to an additional year, for a total of 24 months. Any extensions beyond 24 months would require OPM approval. As another example an agency hires a student who is expected to complete his or her degree within 18 months. The agency would place the student on a term appointment not to exceed 4 years ( i.e., the initial appointment is expected to last for more than 1 year but not more than 4 years). If the student takes longer than expected to complete his or her degree, the agency may extend the initial appointment up to the 4-year limit in increments determined by the agency. The public notification should state that the agency has the option of extending a term appointment made under these provisions up to the 4-year limit. Any extensions beyond the 4-year limit would require OPM approval. Following publication of this rule, OPM will consider crafting a proposed rule to permit delegation of such extensions to agency heads.

Interim § 316.902 Eligibility defines an eligible post-secondary student as an individual who is enrolled or accepted for enrollment in an institution of higher education and pursuing a baccalaureate or graduate degree on at least a part-time basis as determined by the academic institution. An institution of higher education is an entity defined by the Higher Education Act of 1965, in a section codified at 20 U.S.C. 1001(a).

Interim § 316.903 Qualifications explains that individuals appointed under this authority must meet the government-wide OPM-prescribed minimum qualification standard, or OPM-approved agency-specific qualification standard, for the position being filled.

Interim § 316.904 Classification establishes that positions filled under this authority must be classified under the General Schedule or appropriate pay plan to the -99 series of the appropriate occupational group. This section also explains that positions filled under the Federal Wage System must be classified to the -01 series of the appropriate occupational group. Agencies may refer to OPM's, “Introduction to the Position Classification Standards” at https://www.opm.gov/policy-data-oversight/classification-qualifications/classifying-general-schedule-positions/positionclassificationintro.pdf for a definition of these positions. In addition, agencies can refer to the “Handbook of Occupational Groups and Families” available at https://www.opm.gov/policy-data-oversight/classification-qualifications/classifying-general-schedule-positions/occupationalhandbook.pdf.

Students may not be promoted while serving on the temporary appointment ( i.e., an appointment not expected to exceed 1 year). Students may be converted to a new temporary appointment at a higher grade/band level provided the student meets the qualification requirements for the higher grade/band position.

Interim § 316.905 Public notification contains the public notification requirements agencies must follow when using this provision. This section explains that if an agency using this authority does not use USAJOBS to post the position, it must post a job announcement on its home page, or at a minimum, provide a link displayed on the hiring agency's website to the job announcement. Agencies are free to additionally post announcements directly on 3rd party recruitment boards, ( e.g., LinkedIn, Monster, Yello) as long as the agency's homepage also includes a link to a specific announcement. This section also explains that the job announcement must include information about the position being filled to include: The position's title, series, grade level, minimum qualifications, and geographic location; the position's salary; whether the position will be filled on a temporary or term basis (and in the case of a term appointment whether they agency will extend the appointment up to the 4-year limit); whether individuals in the position will be eligible for promotion; the potential for conversion to the agency's permanent workforce; and any pertinent flexibilities that may be offered in conjunction with the position ( e.g., telework opportunities or student loan repayments); and information on how to apply. This section also requires the agency to adhere to the merit system principles and perform appropriate recruiting and advertising activities to foster a diverse and qualified applicant pool when using the authority.

Interim § 316.906 Acquisition of competitive status explains that competitive status is acquired only upon completion of a probationary period (in accordance with 5 CFR part 315, subpart H), after any non-competitive conversion to a permanent appointment pursuant to this subpart. Time spent on a time-limited appointment under this subpart may count toward fulfillment of the probationary period in accordance with 5 CFR 315.802(b).

Interim § 316.907 Tenure upon appointment states that an individual appointed under this provision becomes a career or career-conditional employee only upon completion of the individual's academic requirements and non-competitive conversion to a permanent appointment, unless the individual has already satisfied the requirements for career tenure or is exempt from the service requirement in § 315.201.

Interim § 316.908 Break in program defines break in program as a period of time when a student is working but is unable to go to school or is neither attending classes nor working at the agency. The intent of the program is for students to either attend classes, work at the agency or both. An agency may use its discretion in either approving or denying a request for a break in program.

Interim § 316.909 Promotion explains that post-secondary students appointed for an initial period expected to last more than 1 year but less than 4 years under this part may be promoted noncompetitively provided the individual meets the qualification requirements for the higher grade position and time in grade requirements in 5 CFR part 300, subpart F, and the job announcement used to fill the original position mentioned the possibility of promotions to higher grade levels. Students on initial appointments for less than 1 year are not eligible for promotion.

Interim § 316.910 Conversion establishes that an agency may convert a post-secondary student to a permanent appointment in the competitive service, within that same agency, without further competition if the student has completed the course of study leading to a baccalaureate or graduate degree and meets the qualification standards for the position to which converted. We have added § 315.201(b)(1)(xvii) to indicate that upon conversion, the time served by a post-secondary student under this authority is creditable toward career tenure and may count towards fulfillment of the probationary period in accordance with § 315.802(b).

Interim § 316.911 Reduction in Force (RIF), specifies the tenure groups that post-secondary students are placed in for purposes of 5 CFR part 351. Individuals whose initial appointment is for a period not to exceed 1 year are placed in tenure group 0. Individuals whose initial appointment is for a period expected to last more than 1 year are placed in tenure group III for purposes of 5 CFR part 351.

Interim § 316.912 Termination explains that any appointment made under this authority expires upon the not-to exceed date of that appointment, unless the agency extends the appointment prior to expiration, if not earlier. An agency must terminate the appointment of a student after completion of the individual's academic course of study, unless the student is noncompetitively converted to a permanent position in the competitive service as specified in interim § 316.914.

Interim § 316.913 Numerical limit on the number of appointments describes the restrictions on the number of appointments an agency may make using this authority in a fiscal year (FY). Section 1115 of the NDAA for FY2020 amended 5 U.S.C. 3116(d), limiting the total number of students eligible to be appointed under the expedited hiring authority for post-secondary students. This section specifies that the number of appointments in any FY may not exceed 15 percent of the number of students appointed during the previous fiscal year to positions at the GS-11 level, or below (or equivalent). An appointing agency may not count appointments made using direct hire authorities, non-competitive authorities, excepted service authorities (except Pathways Internship Program appointments under § 213.3402 (a) and 5 CFR part 362, subpart B), or selections under merit promotion authorities, when establishing the limit for a given fiscal year. An agency must count hires through programs that provide for conversion to the competitive service after a trial period, such as the Pathways Intern Program. In calculating this limitation agencies may round up or down to the nearest whole number, if necessary, to eliminate a decimal place. Values ending in “.5” or more may be rounded up to the nearest whole number in determining an agency's cap limitation. Values ending in less than “.5” should be rounded down to the nearest whole number in determining an agency's limitation. For example, 15% of 217 is 32.55, which should be rounded up to 33 or 15% of 235 is 35.25, which should be rounded down to 35. This section also provides that OPM may establish a lower percentage limitation based on any factor OPM deems appropriate. OPM shall notify agencies via the OPM website and other venues (such as the Chief Human Capital Officer's Council) of any changes to the numerical limitation, applicable governmentwide. Changes to the numerical limit for an individual agency will be communicated directly to the agency.

Interim § 316.914 Reporting Requirements, in paragraph (a), describes the type of data and frequency at which agencies must provide information to the Congress and OPM on their use of this authority. Agencies will be required to provide data on the total number of appointments; the grade levels and occupational series of the positions filled; the numerical limit established for the authority; the number of those appointed who have been separated; recruitment activities; and any difficulties encountered in using the authority. OPM will provide written guidance, around the time this rule is published, describing the means by which agencies should collect this information, the timing of such collections, and the groups as to which information should be collected.

Interim § 316.914(b) establishes that OPM may request from agencies any additional information it deems necessary to further evaluate the impact and effectiveness of this authority.

Interim § 316.915 describes the special provisions on the use of the authority by Department of Defense (DoD) in relation to other DoD specific hiring authorities.

Section 3116 of title 5, U.S. Code, as enacted by section 1108 of Public Law 115-232, the John S. McCain National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2019, directs this rulemaking shall be through “interim regulations, with an opportunity to comment.” Therefore, the general notice of proposed rulemaking typically required under 5 U.S.C. 553(b) and 1103(b) is statutorily waived for this rule.

This statute provides Federal agencies with authority to hire interns under a new scheme designed to facilitate an effective pipeline of new prospects for potential permanent appointment to help sustain the Federal workforce. OPM is issuing this rule to implement 5 U.S.C. 3116. This statute establishes a hiring authority for interns into positions at specified grade levels in the competitive service. This regulation allows agencies to make appointments of post-secondary students directly into the competitive service positions, without regard to rating, ranking, veterans' preference, and public notice provisions in 5 U.S.C. 3309-3319 and 3330. The purpose of the authority is to provide a useful tool as part of an overall strategy to implement strategic workforce and recruitment plans.

This interim final rule will affect the operations of over 80 Federal agencies—ranging from cabinet-level departments to small independent agencies. We estimate that this rule will require individuals employed by these agencies to develop policies and procedures to implement the rule and perform outreach and recruitment activities when using the authority. For the purpose of this cost analysis, the assumed average salary rate of Federal employees performing this work will be the rate in 2021 for GS-14, step 5, from the Washington, DC, locality pay table ($138,866 annual locality rate and $66.54 hourly locality rate). We assume that the total dollar value of labor, which includes wages, benefits, and overhead, is equal to 200 percent of the wage rate, resulting in an assumed labor cost of $133.08 per hour.

In order to comply with the regulatory changes in this interim final rule, affected agencies will need to review the rule and update their policies and procedures. We estimate that, in the first year following publication of the final rule, this will require an average of 250 hours of work by employees with an average hourly cost of $133.08. This would result in estimated costs in that first year of implementation of about $33,270 per agency, and about $2,661,600 in total Governmentwide. We do not believe this rule will substantially increase the ongoing administrative costs to agencies (including the administrative costs of administering the program and hiring and training new staff).

This authority will allow agencies to use strategic recruiting to hire post- secondary students to fill professional and administrative positions at general schedule (GS) 11 level and below. When using the authority agencies will have additional flexibility in how these students are hired. Federal agencies would determine recruitment sources and processes for the solicitation of applications and would be held responsible for merit-based selections. This authority when combined with agencies strategic recruitment plans may help agencies better recruit to fill mission critical occupations.

This flexibility is critical to agencies' ability to continue to meet current and future mission needs. Intern programs allow agencies to hire students, while in school, and provide them with on-the-job training to prepare them for a career in the Federal Government. It also introduces students to the wide range of occupations and employment opportunities that the Federal Government employs and offers. In FY 2020, the Federal Government hired fewer than 5,925 students Government-wide (a small portion of the number of interns hired under other authorities). The low number of intern hires is insufficient to build the pipeline needed to sustain the Federal Workforce.

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). In accordance with the provisions of Executive Order 12866, this rule was reviewed by the Office of Management and Budget as a significant, but not economically significant rule.

The Director of the Office of Personnel Management certifies that this rule will not have a significant economic impact on a substantial number of small entities.

This regulation will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant preparation of a Federalism Assessment.

This regulation meets the applicable standard set forth in Executive Order 12988.

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

Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (known as the Congressional Review Act or CRA) (5 U.S.C. 801 et seq. ) requires rules to be submitted to Congress before taking effect. OPM will submit to Congress and the Comptroller General of the United States a report regarding the issuance of this rule before its effective date, as required by 5 U.S.C. 801. The Office of Information and Regulatory Affairs in the Office of Management and Budget has determined that this rule is not a major rule as defined by the CRA (5 U.S.C. 804). The Office of Information and Regulatory Affairs in the Office of Management and Budget has determined that this rule is not a major rule as defined by the CRA (5 U.S.C. 804).

This final regulatory action will not impose any additional reporting or recordkeeping requirements under the Paperwork Reduction Act.

Accordingly, OPM is amending parts 315, 316, and 330 of title 5, Code of Federal Regulations, as follows:

The FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-0618 and Project Identifier 2019-CE-005-AD” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this final rule.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Mike Kiesov, Aviation Safety Engineer, General Aviation & Rotorcraft Section, International Validation Branch, FAA, 901 Locust, Room 301, Kansas City, MO 64106. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0181, dated August 27, 2018 (referred to after this as “the MCAI”), to address an unsafe condition for certain serial-numbered BALÓNY KUBÍČEK spol. s r.o. Model BB78Z, BB85Z, BB92Z, and BB130P balloons. The MCAI states:

You may examine the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-0618.

The FAA reviewed BALÓNY KUBÍČEK spol. s r.o. Servis Bulletin No. BB/52, dated July 23, 2018. This service information includes an example of a weaving defect in the load tape and specifies acceptable materials and procedures for repairing load tapes with visible yellow thread.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI and service information referenced above. The FAA is issuing this AD because it has determined the unsafe condition described previously is likely to exist or develop on other products of the same type design.

This AD requires inspecting the envelope load tape and repairing any envelope load tape having a weaving defect.

Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq. ) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without providing notice and seeking comment prior to issuance. Further, section 553(d) of the APA authorizes agencies to make rules effective in less than thirty days, upon a finding of good cause.

The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because there are no balloons currently on the U.S. registry and thus, it is unlikely that the FAA will receive any adverse comments or useful information about this AD from U.S. operators. Accordingly, notice and opportunity for prior public comment are unnecessary pursuant to 5 U.S.C. 553(b)(3)(B). In addition, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days for the same reasons the FAA found good cause to forego notice and comment.

There are currently no affected products on the U.S. registry. In the event an affected balloon becomes a U.S.-registered balloon, the following is an estimate of the costs to comply with this AD.

The FAA estimates that it would take 1 work-hour per balloon to comply with the inspection required by this AD. The average labor rate is $85 per work-hour. Based on these figures, the FAA estimates the cost of this AD to be $85 per balloon.

In addition, the FAA estimates that repairing the envelope load tape, if necessary, would take 10 work-hours and require parts costing $200 for a cost of $1,050 per balloon.

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

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

The requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because FAA has determined that it has good cause to adopt this rule without prior notice and comment, RFA analysis is not required.

The FAA determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

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

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

(2) Will not affect intrastate aviation in Alaska.

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

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all PW1519G, PW1521G, PW1521G-3, PW1521GA, PW1524G, PW1524G-3, PW1525G, PW1525G-3, PW1919G, PW1921G, PW1922G, PW1923G, and PW1923G-A model turbofan engines. The NPRM published in the Federal Register on June 3, 2021 (86 FR 29707). The NPRM was prompted by reports of cracks in the HPC rotor shaft that resulted in vibration and subsequent IFSDs and UERs. The manufacturer determined that the threads on the HPC rotor shaft were not optimized for load distribution, which resulted in vibration stresses. During one occurrence, oil was released at the high-pressure turbine (HPT) disk bore location. The manufacturer redesigned the HPC front hub and HPC rotor shaft for increased durability and decreased vibration stress. The redesigned HPC front hub is made from nickel to help with corrosion resistance. The threads on the HPC rotor shaft were also redesigned to help distribute the load on the threads and decrease vibration stress. In the NPRM, the FAA proposed to require removal and replacement of the HPC front hub and HPC rotor shaft. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA received comments from one commenter, the Air Line Pilots Association, International (ALPA). ALPA supported the NPRM without change.

The FAA reviewed the relevant data, considered the comments received, and determined that air safety requires adopting the AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. This AD is adopted as proposed in the NPRM.

The FAA reviewed Pratt & Whitney Service Bulletin (SB) PW1000G-A-72-00-0154-00A-930A-D, Issue No. 001, dated May 7, 2021 (PW1000G-A-72-00-0154-00A-930A-D), and Pratt & Whitney SB PW1000G-A-72-00-0101-00B-930A-D, Issue No. 001, dated May 7, 2021 (SB PW1000G-A-72-00-0101-00B-930A-D). These SBs describe procedures for removing and replacing the HPC front hub and HPC rotor shaft.

The FAA estimates that this AD affects 88 engines installed on airplanes of U.S. registry.

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

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

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

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

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

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

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

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

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

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to Leonardo Model A109S and AW109SP helicopters with a vertical fin vibration absorber installation part number (P/N) 109-B810-79-101 installed. The NPRM published in the Federal Register on May 13, 2021 (86 FR 26198). In the NPRM, the FAA proposed, within 30 hours time-in-service (TIS), and thereafter at intervals not to exceed 100 hours TIS, removing the vertical fin vibration absorber installation and, using a mirror and light source, inspecting the rib assembly and depending on the inspection results, removing certain parts from service. The NPRM also proposed to require inspecting the vertical fin vibration absorber installation for hole elongation; for fretting between the plate and the masses, and in between the masses; for fretting on the doubler; and the bolts for scratches and corrosion. Depending on the inspection results, the NPRM proposed removing the vertical fin vibration absorber installation from service. The NPRM also proposed to require, within 12 months TIS, removing the vertical fin vibration absorber installation from service. Finally, the NPRM proposed to prohibit installing an affected part on any helicopter, and provided a terminating action for the 100-hour TIS repetitive inspections.

The NPRM was prompted by EASA AD 2014-0150, dated June 18, 2014 (EASA AD 2014-0150), issued by EASA, which is the Technical Agent for the Member States of the European Union, to correct an unsafe condition for certain AgustaWestland S.p.A. (now Leonardo S.p.a. Helicopters) (formerly Agusta S.p.A.) Model A109S and AW109SP helicopters with an absorber P/N 109-B810-79-101installed. EASA advises that during a scheduled inspection on Model A109S and AW109SP helicopters, cracks and damage were detected on the vertical fin vibration absorber installation and the surrounding structure. EASA stated that investigation results determined the cracks and damage were likely related to the design of the vertical fin vibration absorber installation and incorrect installation. Accordingly, EASA AD 2014-0150 required repetitive inspections and removal of the affected part.

After EASA AD 2014-0150 was issued, EASA determined certain helicopters were not included in the applicability and may also be subject to the unsafe condition. Accordingly, EASA issued EASA AD 2019-0294, dated December 4, 2019 (EASA AD 2019-0294), which supersedes EASA AD 2014-0150. EASA AD 2019-0294 retains the requirements of EASA AD 2014-0150 and expands the applicability, prohibits vertical fin vibration absorber installation P/N 109-B810-79-101 from being installed on any helicopter, and considers removal of the affected part to constitute terminating action for the repetitive inspections. EASA states that the unsafe condition, if not detected and corrected, could affect the structural integrity of the helicopter.

The FAA received no comments on the NPRM or on the determination of the costs.

These helicopters have been approved by EASA and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the European Union, EASA has notified the FAA about the unsafe condition described in its AD. The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed except for a correction to the compliance time for removing the vertical fin vibration absorber installation from service. The NPRM stated that removing this part from service would be required “within 12 months TIS”; the term “TIS” was included in error and has been removed. This change does not increase the economic burden on any operator. Accordingly, the FAA is issuing this AD to address the unsafe condition on these helicopters.

The FAA reviewed AgustaWestland S.p.A. Bollettino Technico No. 109S-58 for Model A109S helicopters, and AgustaWestland S.p.A Bollettino Technico No. 109SP-074 for Model AW109SP helicopters, each dated May 7, 2014. This service information specifies instructions for removing the vertical fin vibration absorber installation, inspecting the rib assembly and vertical fin vibration absorber installation and depending on the inspection results, removing certain parts from service.

EASA AD 2019-0294 applies to certain serial-numbered Model A109S and AW109SP helicopters, whereas this AD applies to all serial-numbered Model A109S and AW109SP helicopters with a certain part-numbered vertical fin vibration absorber installation installed.

The FAA estimates that this AD affects 96 helicopters of U.S. Registry and that operators may incur the following costs in order to comply with this AD. Labor costs are estimated at $85 per work-hour.

Removing and inspecting the vertical fin vibration absorber installation and surrounding structure takes about 8 work-hours for an estimated cost of $680 per helicopter per inspection cycle and $65,280 for the U.S. fleet per inspection cycle.

Replacing the rib assembly, shim, doubler, and bracket will take about 16 work-hours and parts will cost about $10,000 for an estimated cost of $11,360 per helicopter.

According to Leonardo some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. The FAA does not control warranty coverage by Leonardo. Accordingly, all costs are included in this cost estimate.

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

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

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

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

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

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

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

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

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. The Coast Guard has published a special local regulation for this event in 33 CFR 100.704, Table 1 to § 100.704, Line No. 4; however, the existing special location regulation is dated for the first week of May while this year's event is scheduled for September 18, 2021.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be contrary to the public interest because the potential safety hazards associated with the Low Country Splash Open Water Swim taking place on September 18, 2021.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70041. The Captain of the Port Charleston (COTP) has determined that potential hazards associated with the Low Country Splash Open Water Swim event presents a safety concern for anyone in the vicinity of the regulated area during the event. This rule is needed to protect participants, spectators, and the general public in the navigable waters within the regulated area during the Low Country Splash Open Water Swim event.

This rule establishes a special local regulation from 7 a.m. until 11 a.m., on September 18, 2021. The special local regulation will cover all navigable waters within a moving zone, beginning at Daniel Island Pier, south along the coast of Daniel Island, across the Wando River to Hobcaw Yacht Club, south along the coast of Mt. Pleasant, S.C., to Charleston Harbor Resort Marina. The duration of the special local regulation is intended to ensure the safety of participants, spectators, vessels and these navigable waters before, during, and after the scheduled event. No vessel or person will be permitted to enter the regulated area without obtaining permission from Sector Charleston COTP or a designated representative.

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

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

This regulatory action determination is based on: (1) Non-participant persons and vessels may enter, transit through, anchor in, or remain within the regulated area during the enforcement periods if authorized by Sector Charleston COTP or a designated representative; (2) vessels not able to enter, transit through, anchor in, or remain within the regulated area without authorization from Sector Charleston COTP or a designated representative may operate in the surrounding areas during the enforcement period; (3) the Coast Guard will provide advance notification of the special local regulation to the local maritime community by Broadcast Notice to Mariners; (4) the regulated area will impact small designated areas of Wando River, Cooper River, and Charleston Harbor for only 4 hours and thus is limited in time and scope.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule a special local regulation lasting 4 hours. Normally such actions are categorically excluded from further review under paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1.

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. Immediate action is needed to protect persons and property from the potential safety hazards associated with dredging operations. The NPRM process would delay the establishment of the safety zone until after the date of the event and compromise public safety. We must establish this temporary safety zone immediately and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be contrary to the public interest because immediate action is needed to respond to the potential safety hazards associated with dredging operations in the vicinity of Waxhaw, MS starting August 13, 2021.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port (COTP) Sector Lower Mississippi River (LMR) has determined that potential hazards associated with dredging operations between Mile Marker (MM) 593 and 597, scheduled to start on August 13, 2021, would be a safety concern for all persons and vessels on the Lower Mississippi River between MM 593 and MM 597 through September 15, 2021. This rule is needed to protect persons, property, infrastructure, and the marine environment in all waters of the LMR within the safety zone while dredging operations are being conducted.

This rule establishes a temporary safety zone from August 13, 2021 through September 15, 2021. The safety zone will cover all navigable waters of the LMR from MM 593 to MM 597. The duration of this safety zone is intended to ensure the safety of waterway users on these navigable waters during dredging operations.

Entry of persons or vessels into this safety zone is prohibited unless authorized by the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector Lower Mississippi River. Persons or vessels seeking to enter the safety zones must request permission from the COTP or a designated representative on VHF-FM channel 16 or by telephone at 314-269-2332. If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative. The COTP or a designated representative will inform the public of the enforcement times and date for this safety zone through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs), as appropriate.

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

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the size, location, and duration of the safety zone. This safety zone will temporarily restrict navigation on the LMR from MM 593 through MM 597, from August 13, 2021 through September 15, 2021. Moreover, The Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the safety zone, and the rule allows vessels to seek permission to enter the zone.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone that will prohibit entry on a one-mile stretch of the Lower Mississippi River. It is categorically excluded from further review under paragraph L60 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1.

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

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

On December 27, 2020, the President signed into law the Copyright Alternative in Small-Claims Enforcement (“CASE”) Act of 2020. 1 The CASE Act establishes the Copyright Claims Board (“CCB” or “Board”), a voluntary, alternative forum to federal court for parties to seek resolution of copyright disputes that have a low economic value (“small copyright claims”). 2 The creation of the CCB does not displace or limit the ability to bring small copyright claims in federal court, but rather provides a more accessible alternative forum. 3 The CCB has authority to hear copyright infringement claims, claims seeking a declaration of noninfringement, and misrepresentation claims under section 512(f) of title 17. 4 Participation before the CCB is voluntary for all parties, 5 and all determinations are non-precedential. 6 The Copyright Office is in the process of standing up the CCB and intends to promulgate several operational and procedural rules. 7 Congress directed the CCB to begin operations by December 27, 2021, though the Register may, for good cause, extend that deadline by not more than 180 days. 8

Consistent with the overall goal of providing a cost-effective, streamlined alternative to federal litigation, the CASE Act includes provisions addressing the Copyright Act's registration prerequisite to filing an infringement action. In general, the owner of the copyright in a United States work may not initiate an infringement suit until the Office has issued or refused to issue a copyright registration. 9 Additionally, the Copyright Act provides that in most instances, for a copyright owner to qualify for an award of attorneys' fees or statutory damages, the infringed work must have been registered on or before the date the infringement commenced, unless registration is made within three months after the work's first publication. 10 In considering the challenges facing those involved in small copyright claims, the Office noted that while copyright registration “helps to produce a valuable public record of American creativity as well as material information to parties in litigation,” at times it may also act as “a procedural hurdle for copyright claimants . . . who may not be aware of the repercussions of not registering in a timely manner.”  11 Congress similarly noted that “many small claimants currently do not register their works because they do not expect to be able to enforce their rights in federal court.”  12

The CASE Act addresses these concerns by allowing a party to file an infringement claim with the CCB once “a completed application, a deposit, and the required fee for registration” have been delivered to the Office. 13 The legislative history characterizes this approach as taking “a more liberal attitude towards the commencement of a proceeding while registration of a work is in progress.”  14 But before the CCB renders a decision in any infringement dispute, the CASE Act mandates that the work at issue must be registered by the Office, and the other parties in the proceeding must have an opportunity to address the registration certificate. 15 Recognizing that some infringement claims may involve works for which a registration application has been submitted, but for which the Office has not yet rendered a decision, the statute directs the CCB to hold such proceedings in abeyance. 16 If the Office refuses the registration, the CCB action will be dismissed without prejudice. 17 The CCB also may dismiss an action without prejudice if it has been held in abeyance for at least one year, upon providing thirty days written notice to the parties. 18 As the legislative history explains, “[t]his process is intended to strike a balance between still encouraging timely registration of works with the promise of a higher damages caps [in federal court] with the reality that smaller creators may have numerous understandable reasons for not routinely engaging in the registration process.”  19

To ensure that the work at issue in a CCB proceeding is registered in a timely manner before the CCB issues a determination, the CASE Act directs the Office to “establish regulations allowing the Copyright Office to make a decision, on an expedited basis, to issue or deny copyright registration for an unregistered work that is at issue before the Board.”  20

The CASE Act also limits the materials related to a CCB proceeding that must be disclosed under the Freedom of Information Act (“FOIA”). Subject to certain conditions and exceptions, FOIA requires agencies to make their records available to the public either proactively or in response to a request. 21 The CASE Act provides that “[a]ll information relating to proceedings of the Copyright Claims Board under this chapter is exempt from disclosure” under FOIA, except for “determinations, records, and information” that are published on the Office's website and that relate to a CCB final determination. 22

On April 26, 2021, the Office issued a notice of proposed rulemaking (the “NPRM”) requesting public comment on proposed processes for small claims expedited registration and a conforming amendment for disclosures under FOIA. 23 The NPRM proposed to allow a claimant or counterclaimant with a pending copyright registration application to seek expedited review of that application by making such a request and paying the requisite fee, but only after he or she submitted the completed registration application and the respondent either opted in to the CCB proceeding or did not timely opt out. The proposed rule would not enable the CCB to proceed with a dispute involving a work for which registration is still pending or has been denied. Additionally, the NPRM proposed an amendment to the Office's FOIA regulations to reflect that, as required by the CASE Act, only those CCB “determinations, records, and information” that are published on the Office's website and that relate to a CCB final determination are subject to disclosure under FOIA.

The Office received four comments in response to the NPRM. The Office had asked stakeholders to try to submit joint comments where they had agreement, and one set of comments, submitted by the Copyright Alliance, was joined by twenty separate stakeholder groups. 24 One of those organizations, the National Press Photographers Association, also submitted separate comments. Comments were also filed by the Science Fiction and Fantasy Writers of America, Inc. (“SFWA”) and by Verizon. On the whole, the comments were broadly supportive of the proposed rule and conforming amendment, while providing substantive feedback on some specific provisions. Verizon's comments were generally critical of the creation of CCB as an institution and raised concerns about possible abusive actions by claimants.

Having carefully considered each of the comments, the Office now issues a final rule that closely follows the proposed rule, with certain modifications. First, the final rule adjusts the language pertaining to the initiation of an expedited registration request to provide that such a request may be made only after the proceeding has become active. Second, the final rule clarifies that the CCB will provide notice to all parties to a proceeding when a proceeding is dismissed without prejudice after being held in abeyance for more than one year pending a registration decision. Third, the final rule provides additional flexibility as to the methods of payment that may be accepted for small claims expedited registration. Fourth, the final rule specifies the standard governing denials of requests for small claims expedited registration. Finally, the final rule uses the word “request” rather than “claim” to refer to the action a claimant or counterclaimant takes to initiate small claims expedited registration, to remove possible confusion with other uses of the term “claim.”

In the NPRM, the Office noted that it anticipated publishing this rule as an interim rule. 25 Because, however, the public has had an opportunity to comment on the proposed rule, and in light of the limited number of comments received, the Office does not believe that additional written comments are necessary at this time. 26 The Office therefore is publishing the rule as final. As with other CCB regulations, the Office will carefully monitor the operation of these procedures and welcomes CCB participants' feedback as to whether further adjustments should be considered in the future.

The NPRM outlined several regulatory requirements to govern the expedited registration process. Commenters were generally supportive of the regulation's proposed framework and substance. Recommended amendments to the proposed rule were limited to the matters discussed below.

Under the CASE Act, a claim or counterclaim may be asserted before the CCB where “the legal or beneficial owner of the copyright has first delivered a completed application, a deposit, and the required fee for registration of the copyright to the Copyright Office,” and “a registration certificate has either been issued or has not been refused.”  27 The small claims expedited registration provision is designed to reduce the time required for examination of a party's application and, in doing so, streamline claim resolution before the CCB. The NPRM provided that small claims expedited registration may be requested only after a claimant or counterclaimant “has submitted a completed registration application and the respondent has either opted in or has not timely opted out” of the CCB proceeding. This requirement aimed to “ensure that registration applicants do not invoke the CCB to receive special handling treatment at a discounted rate when not genuinely intending to pursue their claim through the CCB.”  28

The Copyright Alliance et al. objected to the inclusion of the phrase “opting in,” noting that the statute does not contain that language and that it therefore could cause confusion. 29 To address that concern, the final rule amends the proposed rule, providing that a claimant or counterclaimant may request small claims expedited registration only after it “has submitted a completed registration application and the proceeding has become active.” The revision reflects that there are several ways for a proceeding to become active, including when a respondent fails to timely opt out or the case is referred from a district court with consent of the parties. 30

The proposed rule reflected the statutory requirement that if the proceeding cannot move forward because a registration certificate for the work is still pending, the CCB will hold the proceedings in abeyance until a decision is made on the application. 31 It also provided that “[i]f the proceeding has been held in abeyance for more than one year, the Copyright Claims Board may dismiss the claim or counterclaim without prejudice after providing thirty days written notice.”  32 The Copyright Alliance et al. asked the Office to clarify “to whom written notice will be provided.”  33 The final rule clarifies that the CCB will provide notice of the dismissal to all parties to the proceeding.

The NPRM provided that a fee would be required to seek small claims expedited registration. 34 In response, two commenters raised questions as to how the Office would handle small claims expedited registration requests for works included in a group registration application and whether the fee in such cases would be higher than for works not included in a group application. 35 To clarify, small claims expedited registration relates to examination of the registration application as a whole, and not to examination of the specific work or works at issue before the CCB. Because the expedited registration fee is paid per registration application, small claims expedited registration for a group application will incur the same fee as is applicable to a single-work application. Thus, there is no need to revise the proposed rule to provide unique fees and procedures for group registrations.

To keep the CCB accessible while helping to offset some of the anticipated cost increases related to small claims expedited registration, the Office has determined that a $50 fee is reasonable. Verizon argued that a $50 fee would be too low and “would incentivize claimants, large or small, to pay only $50 and file some claim at the CCB in order to gain access to a quick registration, a CCB decision, and possible statutory damages.”  36 The Office, however, believes it is important to keep fees low wherever possible to advance the statutory goal of providing a cost-effective alternative to federal court. While the Office appreciates the concerns over potential abuses, it should be noted that the statute specifically includes provisions to deter abusive behavior and empowers the Office to promulgate various regulations to safeguard the CCB, parties, and the public from such practices. 37 The Office believes that such concerns are more properly addressed through the regulatory process than through its fee-setting authority. The final rule thus does not revise the proposed fee and establishes that applicants seeking small claims expedited registration will pay a $50 fee for each request. This fee is in addition to the relevant copyright registration application fee. In line with its overall approach to fee-setting, the Office intends to periodically reassess the reasonableness of the small claims expedited registration fee once additional data about the operation of this service becomes available.

Separately, the Copyright Alliance et al. proposed expanding the permitted methods of payment available for small claims expedited registration. The proposed rule specified that “[t]he fee for small claims expedited registration must be submitted electronically to the Copyright Claims Board and not through the Copyright Office's electronic registration system,” and shall be paid, in accordance with Office instructions posted online, by “credit or debit cards, or directly from [parties'] bank accounts by means of automated clearing house (ACH) debit transactions.”  38 The Copyright Alliance et al. recommended providing greater flexibility by allowing payment using “prepaid cards and other widely accepted online payment options, like PayPal, Zelle, Venmo, and CashApp.”  39 The Office appreciates that providing additional payment options could help to advance the statute's accessibility goals. Presently, however, the Office is unable to accept the alternative forms suggested, including because some are not supported by Pay.gov , and due to additional administrative costs. Nevertheless, in the interest of providing future flexibility, the Office is revising this portion of the final rule to remove the references to specific payment methods and instead to simply state that a claimant or counterclaimant shall follow instructions on the Copyright Office website to make electronic payments by Pay.gov . Such an approach will enable the Office to consider possible additional methods of payment as Pay.gov expands its capabilities.

Finally, commenters addressed the proposed language allowing the Office to deny a request for small claims expedited registration if the requester did not pay the required fee or if the Office determines that the request would be unduly burdensome. Comments submitted by the Copyright Alliance et al. and by SFWA both expressed concern that the proposed rule did not define the term “unduly burdensome.”  40 The Copyright Alliance et al. recommended guarding against uncertainty by adopting language similar to that provided in the Compendium of U.S. Copyright Office Practices in the context of special handling requests. 41 The Compendium states that the Office may reject a request for special handling if the Office “is unable to process the request based on the Office's workload or budget at the time the request is made.”  42 The Office agrees that this language would provide greater certainty as to the considerations governing denial on this basis. Accordingly, the rule has been revised to provide that if the requisite fee has been paid for small claims expedited registration, the Office will grant the request unless the Office “determines that expedited registration under this section would be unduly burdensome based on the Office's workload or budget at the time the request is made.” As under the proposed rule, the Office is authorized to refund the fee in these circumstances.

The final rule also adopts a technical edit to the Office's FOIA regulations to reflect the CASE Act's reference to FOIA. The regulatory language provides that “Copyright Claims Board determinations published on the Copyright Office website and related records and information published on that website” may be disclosed under FOIA. 43 By statute, all other materials related to CCB proceedings are exempt from disclosure under FOIA. 44

Commenters raised two issues related to the proposed rule. First, the Copyright Alliance et al. argued that the rule required a technical edit—the addition of a comma before “and related records” to “clarify that only those records published on the Office's website are . . . subject to FOIA.”  45 In their view, “[w]ithout a comma preceding `and related records,' it is unclear whether `on that website' is intended to modify both `related records and information' or just `information.' ”  46 To clarify, the phrase “on that website” is intended to modify both terms, and therefore only those CCB records published on the Office's website will be subject to FOIA. The Office is not persuaded, however, that the addition of the suggested comma states that rule any more clearly than the text as proposed. Further, it appears that the commenters' concern relates primarily to questions regarding which records are considered confidential and subject to a protective order. 47 Those issues will be addressed in a separate rulemaking. Accordingly, the Office does not believe that the requested change is necessary.

Second, SFWA expressed concern that confidential sales figures submitted to the CCB in connection with proving damages could be “placed on [the CCB's] website or released in response to a FOIA request.”  48 SFWA argued that if such information is subject to FOIA, it “could easily discourage many writers and creators of copyrighted works, whom the CASE Act is intended to help, from bringing claims or raising counterclaims.”  49 The Office recognizes SFWA's concern about protecting sensitive or confidential information, but, as noted, the Office intends to address these issues in a separate rulemaking. Accordingly, the conforming amendment for the Office's FOIA regulations is unchanged in the final rule.

For reasons stated in the preamble, the Copyright Office amends 37 CFR chapter II as follows:

You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. 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:

• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import provisions. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR 721.20, any persons who export or intend to export a chemical substance that is the subject of this rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

The docket includes information considered by the Agency in developing the proposed and final rules. The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2019-0359, is available at https://www.regulations.gov and at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. 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 is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets.

Due to the public health emergency, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

EPA is finalizing SNURs under TSCA section 5(a)(2) for chemical substances which were the subject of PMNs P-16-400, P-17-119, P-17-191, P-17-220, P-17-387, P-17-388, P-18-7, P-18-8, P-18-77, P-18-85, P-18-101, P-18-107, P-18-118, P-18-119, P-18-152, P-18-169, P-18-238, P-18-307, P-18-312, P-19-8, P-19-9, P-19-26, P-19-27, and P-19-45. These SNURs require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.

Previously, in the Federal Register of August 6, 2019 (84 FR 38159) (FRL-9996-62), EPA proposed SNURs for the chemical substances being finalized in this Federal Register document, in addition to proposing SNURs for other chemical substances, which will be addressed in a subsequent Federal Register document. More information on the specific chemical substances subject to this final rule can be found in the Federal Register document proposing the SNURs. The docket includes information considered by the Agency in developing the proposed and final rules, including the public comments received on the proposed rules that are described in Unit IV.

TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four TSCA section 5(a)(2) factors listed in Unit III.

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before manufacture or processing for the significant new use can commence. If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register , a statement of EPA's findings.

TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

• The projected volume of manufacturing and processing of a chemical substance.

• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances and potential human exposures and environmental releases that may be associated with the substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this unit.

During its review of the chemical substances that are the subjects of these SNURs and as further discussed in Unit VI., EPA identified potential risk concerns associated with other circumstances of use that, while not intended or reasonably foreseen, may occur in the future. EPA is designating those other circumstances of use as significant new uses.

By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1) and has referenced it to apply to other SNURs.

Under these procedures a manufacturer or processor may request EPA to determine whether a specific use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in 40 CFR 721.1725(b)(1) with that under 40 CFR 721.11 into a single step.

If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.

EPA received public comments from three identifying entities on the proposed rule. The Agency's responses are presented in the Response to Public Comments document that is available in the docket for this rule. EPA made changes to two of the proposed rules based on these comments, as described in the response to comments.

EPA is establishing significant new use and recordkeeping requirements for chemical substances in 40 CFR part 721, subpart E. In Unit IV. of the proposed SNUR, EPA provided the following information for each chemical substance:

• PMN number.

• Chemical name (generic name, if the specific name is claimed as CBI).

• Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).

• Basis for the SNUR.

• Potentially useful information.

• CFR citation assigned in the regulatory text section of this final rule.

The regulatory text section of these rules specifies the activities designated as significant new uses. Certain new uses, including production volume limits and other uses designated in the rules, may be claimed as CBI.

The chemical substances that are the subjects of these SNURs received “not likely to present an unreasonable risk” determinations under TSCA section 5(a)(3)(C) based on EPA's review of the intended, known, and reasonably foreseen conditions of use. However, EPA has identified other circumstances that, should they occur in the future, even if not reasonably foreseen, may present risk concerns. Specifically, EPA has determined that deviations from the protective measures identified in the PMN submissions could result in changes in the type or form of exposure to the chemical substances, increased exposures to the chemical substances, and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substances. These SNURs identify as a significant new use manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the protective measures identified in the submissions. As a result, those significant new uses cannot occur without first going through a separate, subsequent EPA review and determination process associated with a SNUN.

EPA is issuing these SNURs because the Agency wants:

• To have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.

• To be obligated to make a determination under TSCA section 5(a)(3) regarding the use described in the SNUN, under the conditions of use. The Agency will either determine under section 5(a)(3)(C) that the significant new use is not likely to present an unreasonable risk, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, or make a determination under TSCA section 5(a)(3)(A) or (B) and take the required regulatory action associated with the determination, before manufacture or processing for the significant new use of the chemical substance can occur.

• To be able to complete its review and determination on each of the PMN substances, while deferring analysis on the significant new uses proposed in these rules unless and until the Agency receives a SNUN.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Inventory. Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at https://www.epa.gov/tsca-inventory.

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted, EPA concludes that the designated significant new uses are not ongoing.

When the chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, the identities of many of the chemical substances subject to this rule have been claimed as confidential (per 40 CFR 720.85). Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.

EPA designated August 6, 2019 (the date of FR publication of the proposed rule) as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule.

Persons who began commercial manufacture or processing of the chemical substances for a significant new use identified on or after that date will have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and EPA would have to take action under section 5 allowing manufacture or processing to proceed.

EPA recognizes that TSCA section 5 does not require development of any particular new information ( e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, Order or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.

In the absence of a rule, Order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. of the proposed rule lists potentially useful information for all SNURs listed here. Descriptions are provided for informational purposes. The potentially useful information identified in Unit IV. of the proposed rule will be useful to EPA's evaluation in the event that someone submits a SNUN for the significant new use. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance, which may assist with EPA's analysis of the SNUN.

EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol election. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). For more information on alternative test methods and strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.

The potentially useful information described in Unit IV. of the proposed rule may not be the only means of providing information to evaluate the chemical substance associated with the significant new uses. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA sections 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

• Human exposure and environmental release that may result from the significant new use of the chemical substances.

According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket for this rulemaking.

Additional information about these statutes and executive orders can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

This action establishes SNURs for new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).

According to PRA, 44 U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.

The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Regulatory Support Division, Office of Mission Support (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

Pursuant to RFA section 605(b), 5 U.S.C. 601 et seq., I hereby certify that promulgation of this SNUR would not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and 11 in FY2018. Only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. Therefore, the potential economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq. ).

This action will not have federalism implications because it is not expected to have a substantial direct effect on States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

This action will not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes, significantly or uniquely affect the communities of Indian Tribal governments, and does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply to this action.

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this action is not a significant regulatory action under Executive Order 12866.

In addition, since this action does not involve any technical standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action.

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994).

This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA will submit a rule report containing this rule and other required information to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, for the reasons stated in the preamble, 40 CFR chapter I is amended as follows:

You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. 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:

• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import provisions promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and Orders under TSCA, which would include the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

The dockets include information considered by the Agency in developing the proposed and final rules. The dockets for this action, identified by docket identification (ID) numbers EPA-HQ-OPPT-2018-0627, -2018-0777, -2019-0359, -2019-0228, -2019-0494, and -2019-0530, are available at https://www.regulations.gov and at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. 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 is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280.

Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

EPA is finalizing SNURs under TSCA section 5(a)(2) for certain chemical substances which were the subject of PMNs. EPA will address the other proposed SNURs in future Federal Register notices.

Previously, EPA proposed SNURs for these chemical substances and established the record for these SNURs in the following Federal Registers and docket ID numbers:

• October 3, 2018 (83 FR 49903) (FRL-9983-81); Docket ID No. EPA-HQ-OPPT-2018-0627;

• July 31, 2019 (84 FR 37199) (FRL-9994-62); Docket ID No. EPA-HQ-OPPT-2018-0777;

• August 6, 2019 (84 FR 38158) (FRL-9996-62); Docket ID No. EPA-HQ-OPPT-2019-0359;

• October 11, 2019 (84 FR 54816) (FRL-9998-64); Docket ID No. EPA-HQ-OPPT-2019-0228;

• November 4, 2019 (84 FR 59335) (FRL-10000-54); Docket ID No. EPA-HQ-OPPT-2019-0494; and

• December 6, 2019 (84 FR 66855) (FRL-10001-48); Docket ID No. EPA-HQ-OPPT-2019-0530.

The dockets include information considered by the Agency in developing the proposed and final rules, including public comments and EPA's responses to the public comments received.

TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III.

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1(c), persons subject to these SNURs must comply with the significant new use notice (SNUN) requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN and before the manufacture or processing for the significant new use can commence, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination. If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register , a statement of EPA's findings.

When the Agency issues an order under TSCA section 5(e), section 5(f)(4) requires that the Agency consider whether to promulgate a SNUR for any use not conforming to the restrictions of the TSCA Order or publish a statement describing the reasons for not initiating the rulemaking. TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

• The projected volume of manufacturing and processing of a chemical substance.

• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, and potential human exposures and environmental releases that may be associated with possible uses of these chemical substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this unit.

By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1) and has referenced it to apply to other SNURs.

Under these procedures a manufacturer or processor may request EPA to determine whether a specific use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in 40 CFR 721.1725(b)(1) with that under 40 CFR 721.11 into a single step.

If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.

EPA received public comments from nine identifying entities on the proposed rules. The Agency's responses are presented in the Response to Public Comments document that is available in each of the dockets for these rules. EPA made changes to three of the proposed rules as described in the response to comments.

EPA is establishing significant new use and recordkeeping requirements for chemical substances in 40 CFR part 721, subpart E. In Unit IV. of the proposed SNURs, EPA provided the following information for each chemical substance:

• PMN number.

• Chemical name (generic name, if the specific name is claimed as confidential business information (CBI)).

• Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).

• Effective date of and basis for the TSCA Order.

• Potentially Useful Information. This is information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substances if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR.

• CFR citation assigned in the regulatory text section of these rules.

The regulatory text section of these rules specifies the activities designated as significant new uses. Certain new uses, including production volume limits and other uses designated in the rules, may be claimed as CBI.

These final rules include PMN substances that are subject to orders issued under TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). Those TSCA Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The final SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA Orders, consistent with TSCA section 5(f)(4).

Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA Order usually requires that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL). The comprehensive NCELs provisions in TSCA Orders include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. No comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the 40 CFR 721.63 respirator requirements may request to do so under 40 CFR 721.30. EPA expects that persons whose 40 CFR 721.30 requests to use the NCELs approach for SNURs that are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA Order.

During review of the PMNs submitted for the chemical substances that are subject to these SNURs and as further discussed in Unit IV. of the proposed rules, EPA concluded that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. Based on such findings, TSCA Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. As a general matter, EPA believes it is necessary to follow TSCA Orders with a SNUR that identifies the absence of those protective measures as significant new uses to ensure that all manufacturers and processors—not just the original submitter—are held to the same standard.

EPA is issuing these SNURs because the Agency wants to

• Receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.

• Have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use; and

• Be obligated to make a determination under TSCA section 5(a)(3) regarding the use described in the SNUN, under the conditions of use. The Agency will either determine under TSCA section 5(a)(3)(C) that significant new use is not likely to present an unreasonable risk, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, or make a determination under TSCA section 5(a)(3)(A) or (B) and take the required regulatory action associated with the determination, before manufacture or processing for the significant new use of the chemical substance can occur.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at https://www.epa.gov/tsca-inventory.

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted, EPA concludes that the designated significant new uses are not ongoing.

When chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA Orders have been issued for all the chemical substances that are the subject of this rule, and the PMN submitters are prohibited by the TSCA Orders from undertaking activities which will be designated as significant new uses. The identities of 50 of the 57 chemical substances subject to this rule have been claimed as confidential (per 40 CFR 720.85). Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.

Furthermore, EPA designated the publication dates of the proposed rules (see Unit II.) as the cutoff dates for determining whether the new uses are ongoing. The objective of EPA's approach has been to ensure that a person could not defeat a SNUR by initiating a significant new use before the effective date of the final rule.

In the unlikely event that a person began commercial manufacture or processing of the chemical substances for a significant new use identified as of the abovementioned dates, that person will have to cease any such activity upon the effective date of the final rule. To resume their activities, that person would have to first comply with all applicable SNUR notification requirements and wait until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.

EPA recognizes that TSCA section 5 does not require development of any particular new information ( e.g., generating test data) before submission of a SNUN. There is an exception:

If a person is required to submit information for a chemical substance pursuant to a rule, TSCA Order or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.

In the absence of a rule, TSCA Order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to them or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. of the proposed rule lists potentially useful information for all SNURs listed in this document. Descriptions are provided for informational purposes. The information identified in Unit IV. of the proposed rule will be potentially useful to EPA's evaluation in the event that someone submits a SNUN for the significant new use. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance.

EPA strongly encourages persons, before performing any testing, to consult with the Agency. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). For more information on alternative test methods and strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.

In some of the TSCA Orders for the chemical substances identified in this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of specified tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. The SNURs contain the same production volume limits as the TSCA Orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture or processing.

Any request by EPA for the triggered and pended testing described in the TSCA Orders was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the PMN substances. Further, any such testing request on the part of EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models.

The potentially useful information identified in Unit IV. of the proposed rule may not be the only means of addressing the potential risks of the chemical substance associated with the designated significant new uses. However, submitting a SNUN without any test data or other information may increase the likelihood that EPA will take action under TSCA sections 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that provide detailed information on the following:

• Human exposure and environmental release that may result from the significant new use of the chemical substances.

• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPA's complete economic analyses are available in each docket listed in Unit II.

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

This action establishes SNURs for several new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).

This action is not subject to Executive Order 13771 (82 FR 9339, February 3, 2017), because this action is not a significant regulatory action under Executive Order 12866.

According to the PRA (44 U.S.C. 3501 et seq. ), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The information collection requirements associated with SNURs have already been approved by OMB pursuant to the PRA under OMB control number 2070-0012 (EPA ICR No. 574). This rule does not impose any burden requiring additional OMB approval.

The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this action. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. The Information Collection Request (ICR) covering the SNUR activities was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment.

If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Regulatory Support Division, Office of Mission Support (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

Pursuant to the RFA section 605(b) (5 U.S.C. 601 et seq. ), the Agency hereby certifies that promulgation of these SNURs would not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, EPA has concluded that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, EPA received 7 SNUNs in Federal fiscal year (FY) 2013, 13 in FY2014, 6 in FY2015, 10 in FY2016, 14 in FY2017, and 11 in FY2018 and only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. Therefore, the potential economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq. ).

This action will not have a substantial direct effect on States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

This action does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply to this action.

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children. EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order.

This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.

In addition, since this action does not involve any technical standards subject to NTTAA section 12(d) (15 U.S.C. 272 note).

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994).

This action is subject to the CRA (5 U.S.C. 801 et seq. ), and EPA will submit a rule report containing this rule and other required information to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, for the reasons stated in the preamble, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2020-0118 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before October 18, 2021. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2020-0118, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW, Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of April 15, 2020 (85 FR 20910) (FRL-10006-54), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petition (PP 9F8799) by Makhteshim Agan of North America (d/b/a ADAMA), 3120 Highwoods Blvd., Suite 100, Raleigh, NC 27604. The petition requested that 40 CFR 180.680 be amended by establishing tolerances for residues of the nematicide fluensulfone, in or on soybean, seed at 0.1 parts per million (ppm); soybean, forage at 7.0 ppm; and soybean, hay at 20 ppm. That document referenced a summary of the petition prepared by Makhteshim Agan of North America, the petitioner, which is available in the docket, http://www.regulations.gov. Two comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA is establishing a tolerance that varies from what is requested. The reason for these changes is explained in Unit IV.D.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified therein, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for fluensulfone, including exposure resulting from the tolerance established by this action. EPA's assessment of exposures and risks associated with fluensulfone follows.

In an effort to streamline Federal Register publications, EPA is not reprinting here summaries of its analyses that have previously appeared in the Federal Register in previous tolerance rulemakings for the same pesticide. To that end, this rulemaking refers the reader to several sections from the April 13, 2018 tolerance rulemaking for residues of fluensulfone that remain unchanged for an understanding of the Agency's rationale in support of this rulemaking. See 83 FR 15971 (FRL-9975-76). Those sections are: Units III.A (Toxicological Profile); III.B. (Toxicological Points of Departure/Levels of Concern); and III.C. (Exposure Assessment), except as explained in the next paragraphs; III.D. (Safety Factor for Infants and Children).

Exposure assessment updates. EPA's exposure assessments have been updated to include the additional exposure from use of fluensulfone on soybeans. EPA's aggregate exposure assessment incorporated this additional dietary exposure, as well as exposure from drinking water and from residential sources. The new use does not result in an increase in the estimated residue levels in drinking water or in exposure from residential sources relative to those used in the last assessment.

Further information about EPA's risk assessment and determination of safety supporting the new fluensulfone tolerance can be found at http://www.regulations.gov in the document titled “Fluensulfone. Human Health Risk Assessment for a New Use on Soybean.” in docket ID EPA-HQ-OPP-2020-0118.

Assessment of aggregate risks. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure (PODs) to ensure that an adequate margin of exposure (MOE) exists. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure.

Acute dietary risks are below the Agency's level of concern: The acute dietary risk estimate is 21% of the aPAD for infants (<1 year old), the group with the highest exposure. Chronic dietary risks are below the Agency's level of concern: 4.8% of the cPAD for infants (<1 year old), the group with the highest exposure. EPA has concluded the combined short-term food, water, and residential exposures result in aggregate margins of exposure above the level of concern of 100 for all scenarios assessed and are not of concern. EPA has determined that quantification of cancer risk using a non-linear approach ( i.e., reference dose) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to fluensulfone; the chronic aggregate assessment did not result in risk estimates of concern.

Determination of safety. Therefore, based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to fluensulfone residues. More detailed information on this action to establish a tolerance on soybean can be found in the document entitled, “Fluensulfone. Human Health Risk Assessment for a new use on Soybean” by going to the docket established by this action, which is described under ADDRESSES .

There are adequate residue analytical methods for enforcing tolerances for fluensulfone residues of concern in/on the registered plant and livestock commodities. These methods include two high-performance liquid chromatography methods with tandem mass-spectroscopy detection (HPLC/MS/MS) for determining residues in/on plant and livestock matrices.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for fluensulfone on soybean.

EPA received two comments from anonymous sources. One comment cited concern regarding fluoride; this comment is not relevant to the Agency's evaluation of a tolerance for the proposed new use of fluensulfone on soybean. The other comment expresses concern about pesticides in general, and requests that the Agency deny use of fluensulfone without specifically mentioning the new use on soybean. While the agency recognizes that some people do not like pesticides, the Agency has evaluated the aggregate risk of fluensulfone and has determined that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to fluensulfone residues.

The agency has determined that tolerances are not needed for soybean, forage and soybean, hay, as the label contains a feeding restriction for those commodities, and the commodities will not be in the channels of trade. Further, the agency has recommended amending the proposed tolerance for soybean, seed from 0.1 ppm to 0.07 ppm based upon the OECD MRL/Tolerance Calculation Procedures.

Therefore, a tolerance is established for residues of fluensulfone on soybean, seed at 0.07 ppm.

This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq. ).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows: