OPM is modifying eligibility for coverage under the FEDVIP to certain Federal employees on temporary appointments and certain employees on seasonal and intermittent schedules who became eligible for Federal Employees Health Benefits (FEHB) coverage in 2015, which includes Postal employees on temporary appointments and seasonal and intermittent schedules. This rule also expands access to FEDVIP benefits to certain firefighters on temporary appointments and intermittent emergency response personnel who became eligible for FEHB coverage in 2012. This rule also updates the provisions on enrollment for active duty service members who become eligible for FEDVIP as uniformed service retirees pursuant to the FY17 NDAA. In addition, this rule adds an exception to decrease an enrollment type and an exception to cancel an enrollment for certain enrollees who may become eligible for dental and/or vision services from the VA and who do not pay premiums on a pre-tax basis. Lastly, the rule also has technical corrections and clarifications to the part.

The authority to extend FEDVIP eligibility to additional groups of employees falls under OPM's regulatory authority at 5 U.S.C. 8962 and 5 U.S.C. 8992 to determine eligibility of employees based on the nature and type of employment. On October 21, 2021, OPM issued a proposed rule (86 FR 57764) to amend 5 CFR part 894. The proposed rule had a 60-day comment period during which OPM received a total of nine comments. This final rule adopts most of the rule as proposed and has amendments to §§ 894.101, 894.105, 894.201, 894.202, 894.203, 894.301, 894.302, 894.401, 894.403, 894.501, 894.502, 894.504, 894.507, 894.510, 894.602, 894.702, and 894.704. There are also technical corrections to §§ 894.511 and 894.601, and updates throughout 5 CFR part 894 that clarify certain provisions that apply to both Federal employees and employees of the United States Postal Service (USPS).

OPM received seven comments from individual members of the public, Federal employees, Federal agencies, and an employee union on the proposed rule, and an additional two comments were not responsive to the subject matter discussed in the rule. The majority of commenters expressed support for the regulation regarding the expansion of FEDVIP to additional Federal employees and Postal employees. This rule will align benefits for similarly situated employees, add exceptions for decreasing enrollment type and cancelling an enrollment, and clarify existing provisions.

Two commenters expressed general concerns about Federal benefits programs. One commenter stated that instead of opening up FEDVIP to more employees, OPM should consider requiring FEHB plans to include basic preventive dental care and eye exams/glasses as preventive care saves money. Another commenter suggested discontinuing FEDVIP stating that it favors insurance companies. OPM declines these suggestions and notes that FEDVIP dental plans include preventive services such as routine services like exams and cleanings at no cost to enrollees when using in-network dentists. FEDVIP vision plans offer annual coverage for routine care such as vision exams and routine products such as vision lenses and frames. There are FEHB plans that offer some dental and vision benefits, and eligible enrollees have an option to enroll in FEDVIP for comprehensive dental and/or vision insurance.

Several commenters had similar comments and supported the regulation stating that the expansion is necessary and overdue. The commenters stated Federal employees performing the same job should not receive different benefits. They stated that expanding FEDVIP to more Federal employees will have a positive impact, including on FEDVIP rates, and will foster more competition in hiring and the ability to retain a strong workforce in the Federal Government. They also stated this could foster greater competition with the private sector. One of the commenters stated that all Federal employees eligible for FEHB should be able to receive dental and vision coverage and suggested that the FEHB Program should include basic dental and vision benefits with the option of choosing a plan with more coverage for more serious dental care.

Another commenter who supports the rule detailed its importance for wildland firefighters and discussed the detrimental health effects of wildfires such as eye and respiratory tract irritation, reduced lung function, bronchitis, exacerbation of asthma and heart failure, and premature death. The commenter also discussed the importance of firefighters for public safety and the need for the Federal Government to hire more wildland firefighters. The commenter stated expansion of FEDVIP to seasonal, temporary, and/or intermittent employees, including firefighters, will allow the Federal Government to hire and retain a strong workforce that will overall benefit the public and the environment.

OPM appreciates the supportive comments about expanding FEDVIP to additional employees. In response to the comment that expanding FEDVIP will result in competitive rates for employees, OPM cannot estimate the impact on premium rates as we cannot predict the uptake of the eligible population. In response to the suggestion that FEHB plans should include basic dental and vision, OPM notes that is outside the scope of this rule and there are FEHB plans with dental and vision benefits which vary by plan.

OPM received several comments from a commenter in support of the proposed rule as it impacts non-career Postal employees as well as recommendations on the rule. The commenter supported the rule's proposal that newly eligible employees may enroll within 60 days of publication of the final rule, after the employing office notifies employees of their eligibility for FEDVIP. The commenter explained that the USPS normally uses 60 days to allow newly hired non-career employees to enroll in a non-career health benefit plan after they are hired. The commenter recommended that OPM authorize an enrollment procedure similar to the process that is used to enroll City Carrier Assistants in USPS's non-career health benefits health plan. OPM would like to clarify that authorization of a procedure is unnecessary, and that FEDVIP enrollment takes place through BENEFEDS, a secure enrollment website sponsored by OPM that allows eligible individuals to enroll or change enrollment in a FEDVIP plan.

The commenter also identified a possible ambiguity regarding eligibility as the preamble of the proposed rule states that certain Postal temporary employees and Postal employees on seasonal and intermittent schedules expected to work 130 hours per calendar month, for at least 90 days, would be eligible for FEDVIP. However, the proposed paragraph (e)(5) of 5 CFR 894.302 regarding the eligibility of temporary employees cross-referenced 5 CFR 890.102(j), a provision in the FEHB regulation stating that only non-Postal employees on temporary appointments, and non-Postal employees working on seasonal and intermittent schedules are eligible for FEHB. We have modified the regulatory text throughout 5 CFR 894.302 and added paragraphs (e)(5) and (6), (f)(3), and (g)(2) to clarify that Postal employees on temporary appointments and those on seasonal and intermittent schedules are eligible for FEDVIP.

In addition, the preamble to the proposed rule included an estimate of Federal employees in the impacted categories that would become eligible for FEDVIP. However, there was not an estimate of the impacted categories of Postal employees who would become eligible. As of September 2022, OPM estimates 72,100 Federal employees in the impacted categories would become eligible for FEDVIP. As of fiscal year 2022, approximately 118,609  1 Postal employees in the impacted categories would become eligible for FEDVIP. This estimate of Postal employees is based on the category of Postal employees referred to as full-time non-career (sometimes referred to as pre-career) employees and generally corresponds to the category of employees affected by the modification of FEDVIP eligibility under this final rule.

OPM has made several changes to this final rule regarding eligibility for Postal employees on temporary appointments and seasonal and intermittent schedules and technical corrections. First, we updated the List of Subjects in 5 CFR part 894 to remove the terms “Hostages, Iraq, Kuwait, and Lebanon” to update the topics currently in FEDVIP regulations. Second, the final rule updates 5 CFR 894.101 to clarify that the term “enrollee” also includes employees or annuitants of the USPS. Third, the proposed rule cross-referenced 5 CFR 890.102(j) in several paragraphs in § 894.302, which would inadvertently exclude Postal employees from eligibility for the FEDVIP modification. To correct this, the final rule in § 894.302 adds new paragraphs (e)(5) and (6), (f)(3), and (g)(2) to clarify that Postal employees on temporary appointments and seasonal and intermittent schedules are eligible for FEDVIP. Fourth, the final rule clarifies in 5 CFR 894.301(d) that employees in positions providing emergency response services for wildland fire protection as described in in 5 CFR 890.102(h), and employees performing similar types of emergency response services for whom, upon request by the employing agency, OPM granted eligibility, as described in 5 CFR 890.102(i), are eligible for FEDVIP. In § 894.403, the final rule adds paragraph (b)(6) to clarify that Postal Service employees who are not eligible for FEHB may not pay FEDVIP premiums on a pre-tax basis. This applies to Postal Service employees affected by the rule—generally non-career Postal employees (temporary Postal employees as well as certain Postal employees on seasonal and intermittent schedules).

The proposed rule proposed changing the term “service” to “Federal employment” in 5 CFR 894.501(c) to clarify that “service” refers to Federal employment. However, the final rule does not adopt this change and retains the original regulatory language since “service” refers to employment at both Federal agencies and USPS, and the clarification is not necessary. The proposed rule did add paragraph (h) to § 894.501 to clarify that an eligible individual may enroll within 60 days of the individual's annuity or compensation being restored after having been terminated, and that proposed change is adopted.

In addition, the final rule clarifies inconsistencies in the preamble and regulatory text of the proposed rule regarding a decrease in enrollment type or cancellation of an enrollment because of eligibility for dental or vision benefits from the VA. The proposed rule had inconsistencies in whether an enrollee or family member had to only be eligible for dental or vision benefits from the VA, or also enroll in VA dental or vision benefits for the decrease in enrollment type or cancellation to apply. The final rule clarifies that the enrollee or family member must only be eligible for dental or vision benefits from the VA to decrease enrollment type under new paragraph (a)(3) of § 894.510 and to cancel an enrollment under § 894.602(c). OPM is using the broader term of eligibility since in certain circumstances, veterans may not be required to enroll in order to receive certain VA benefits.

The final rule also clarifies that under new paragraph (a)(3) of 5 CFR 894.510 that enrollees, identified in § 894.403(b), who pay premiums on a post-tax basis may decrease enrollment type if an eligible family member becomes eligible for VA dental or vision benefits. Under 5 CFR 894.510(a)(3), the enrollee must submit the request within 60 days after notification of eligibility for VA dental or vision benefits of a family member or TRICARE-eligible individual (TEI) family member. The rule also clarifies that cancelling an enrollment under § 894.602(c) due to an enrollee becoming eligible for VA dental or vision benefits applies to enrollees, identified in § 894.403(b), who do not pay premiums on a pre-tax basis. For enrollees requesting to cancel enrollment under § 894.602(c), the enrollee must submit the request within 60 days of notification of eligibility for VA dental or vision benefits. OPM is also clarifying that these exceptions are not qualifying life events (QLEs), but rather exceptions for this group of enrollees, namely veterans, and only applies to enrollees who do not pay premiums on a pre-tax basis. OPM must follow Internal Revenue Service rules in determining which events are QLEs, and these exceptions do not implicate enrollees eligible for premium conversion (pre-tax payment of premiums). Enrollees who are eligible for premium conversion cannot decrease enrollment type under the exception at § 894.510 or cancel enrollment mid-year.

The final rule does not include the proposed changes to § 894.512 to change “Federal Government” to “Federal employment” or “service” to “employment” as this clarification is not necessary. Additionally, the final rule also amends § 894.601(i) to only discuss when FEDVIP coverage stops for an enrollee or sponsor who cancels coverage because they are eligible for or enrolled in VA dental or vision benefits. The proposed rule at § 894.601(i) included language that is more appropriate for § 894.602 regarding the responsibility of a sponsor to notify family members of changes in enrollment, and the final rule describes this responsibility of a sponsor at § 894.602. An enrollee or sponsor requesting to cancel an enrollment under § 894.601(i) must submit the request within 60 days after notification of eligibility for VA dental or vision benefits. The final rule also clarifies that § 894.602(b), which allows cancellation due to deployment to active military duty, not only applies to an employee and their spouse but also all enrollees, including an annuitant or their spouse. The final rule does not include the proposed change to § 894.704 to insert “Federal employment” in relation to where an individual may retire from and instead clarifies that this may also include the USPS in addition to the Federal Government.

The final rule also clarifies throughout 5 CFR part 894 that certain provisions that apply to Federal employees also apply to employees of the USPS. This clarification was needed since currently an employee of the USPS is included in the definition of “employee” only for purposes of subpart A.

The final rule also clarifies that the system of records notice for this collection is OPM Central-26 rather than OPM Central-1 as listed in the proposed rule.

This final rule will allow newly eligible individuals to enroll themselves and cover their eligible family members in FEDVIP. Under current FEDVIP regulations at 5 CFR 894.302, Federal employees in certain positions are not eligible to enroll in FEDVIP. This final rule extends eligibility to enroll in FEDVIP to certain temporary Federal employees and certain Federal employees on seasonal and intermittent schedules who are eligible for the FEHB Program. Consistent with Internal Revenue Code section 4980H, OPM expanded eligibility to enroll in the FEHB Program to these categories of Federal employees who are expected to work 130 hours per month, for at least 90 days, at 79 FR 62325 (October 17, 2014). This final rule expands eligibility to enroll in FEDVIP to this same group of employees under 5 CFR part 894 and allows them to enroll in FEDVIP.

In addition, the rule allows certain temporary Postal employees as well as certain Postal employees on seasonal and intermittent schedules expected to work 130 hours per calendar month, for at least 90 days, to enroll for FEDVIP coverage as the USPS does not offer separate dental and vision plans for these employees.

Current FEDVIP regulations do not allow certain firefighters on temporary appointments and intermittent emergency response personnel for wildland fire protection to enroll. These employees are distinct from the categories described above because they might not meet the requirement of being expected to work 130 hours per calendar month, for at least 90 days. In 2012, upon request by an employing agency, eligibility to enroll in the FEHB Program was extended to employees in positions that provide emergency response services for wildland fire protection, and to employees performing similar types of emergency response services if approved by OPM. This final rule similarly provides these employees eligibility to enroll in FEDVIP.

Enrollments for newly eligible individuals pursuant to this rule will be accepted during a 60-day period after the issuance of the final rule that begins when the employing office notifies employees of their eligibility to enroll in a FEDVIP plan. If a Federal or Postal employee is on a temporary appointment or seasonal or intermittent schedule and is expected to work or does work 130 hours per calendar month, for at least 90 days, then the individual is eligible to enroll upon notification by their employing office. If an employee is a firefighter or intermittent emergency response personnel, they are eligible upon notification of their employing office. Employing offices must determine eligibility of new and current employees and upon determining eligibility, promptly offer employees made eligible by this rule an opportunity to enroll in FEDVIP and coverage will become effective pursuant to 5 CFR 894.504.

This final rule clarifies when active duty service members who become uniformed services retirees may enroll in FEDVIP outside of open season. A sponsor on active duty becomes eligible for FEDVIP as a TEI, pursuant to Public Law 108-496, when the individual becomes a uniformed services retiree. Under current regulations at 5 CFR 894.501(b), an individual may enroll within 60 days of becoming eligible. Under 5 CFR 894.504, the individual's enrollment is effective the first day of the pay period following the one in which the Administrator receives the enrollment.

However, a sponsor on active duty who retires and becomes a TEI could experience a 30-day break in coverage if that individual enrolls when becoming eligible as a uniformed services retiree. OPM is revising § 894.501(e) and redesignating it as § 894.501(f) to allow these active duty service members who will experience a status change to a uniformed services retiree to enroll in FEDVIP. Such service members may enroll beginning 31 days before the service member loses other dental or vision coverage, and during an additional 60 days after becoming eligible to enroll. OPM is also amending 5 CFR 894.504(d) to make the effective date for these individuals enrolling outside of open season to be no earlier than the date the active duty service member lost other coverage.

This final rule amends certain provisions in 5 CFR part 894 to clarify a current qualifying life event applies to all enrollees and adds exceptions for enrollees to decrease an enrollment type and cancel a FEDVIP enrollment. In 5 CFR 894.511, OPM amends the language to clarify the QLE allowing an enrollee to decrease an enrollment if a spouse who is enrolled becomes deployed to active military duty. Section 894.511(b) has been amended to use the term “enrollee” as defined in § 894.101 since it includes Federal employees, employees of the USPS, annuitants, compensationers, and TEIs. In addition, the rule adds an exception at new paragraph (a)(3) of § 894.510 for an enrollee, as specified in § 894.403(b), whose FEDVIP premiums are not paid on a pre-tax basis, to decrease an enrollment type if a covered family member becomes eligible for dental or vision benefits from the VA.

In § 894.601, OPM amends paragraph (a) to clarify that an employee of the USPS is included in the provision on when FEDVIP coverage stops after the individual is no longer eligible. In 5 CFR 894.601, OPM also adds a new paragraph (i) that addresses when FEDVIP coverage stops if an enrollee or sponsor is eligible to cancel an enrollment outside of open season. In 5 CFR 894.602, OPM adds an exception to the current rules on cancellation for an enrollee identified in § 894.403(b), who does not pay FEDVIP premiums on a pre-tax basis, to cancel their FEDVIP enrollment if the enrollee is determined to be eligible for dental or vision benefits through the VA. If the enrollee is a sponsor who meets one of the conditions in 5 CFR 894.309(a)(3)(iii) and cancels a self plus one or self and family enrollment in a FEDVIP dental plan, the sponsor must notify eligible family members about the change in enrollment. Then pursuant to § 894.811, a TEI family member can accept the responsibility to self-certify and enroll in a FEDVIP dental plan as a TEI certifying family member and cover other TEI family members.

In addition, this final rule includes technical corrections. These technical corrections include the following: incorporated capitalization and italicization of certain defined terms throughout 5 CFR part 894; updated the definition of stepchild in 5 CFR 894.101; amended 5 CFR 894.201 to use the more inclusive terminology of “enrollee” instead of the terms “employee” and “annuitant” since TEIs are also enrollees; removed 5 CFR 894.203 since the situations for changing a family member under a self plus one enrollment or changing to a self only enrollment are covered in 5 CFR 894.510 and 894.511; and amended 5 CFR 894.511 to use the more inclusive terminology of “enrollee” instead of the terms “employee,” “annuitant,” or “compensationer” since Postal employees and TEIs are also enrollees. This rule also incorporates italicization of defined terms in 5 CFR 894.502.

While this rule expands the number of individuals who are potentially eligible for FEDVIP, OPM does not believe this regulation will have a large impact on the broader dental and vision insurance markets. FEDVIP generally constitutes a smaller percentage of dental and vision insurance carrier's overall books of business. OPM has contracted with twelve dental carriers and five vision carriers to offer plans under FEDVIP. There are currently twenty-three dental plan options available across FEDVIP from these twelve dental carriers. Within the five vision carriers, there are currently ten vision plan options that are nationwide and internationally available to all potential enrollees.

As of September 2022, OPM estimates 72,100 Federal employees in the impacted categories would become eligible for FEDVIP. As of fiscal year 2022, approximately 118,609  2 Postal employees in the impacted categories would become eligible for FEDVIP. This estimate of Postal employees is based on the category of Postal employees referred to as full-time non-career (sometimes referred to as pre-career) employees and generally corresponds to the category of employees affected by the modification of FEDVIP eligibility under this final rule. In the proposed rule published on October 19, 2021, at 86 FR 57764, OPM sought comments on the following to supplement its analysis on the affected population:

1. How will the regulation impact changes to enrollment in FEDVIP?

2. How will the allowance of new categories of employees impact FEDVIP?

While there were no comments on how the regulation will impact changes to enrollment in FEDVIP, OPM did receive comments on expanding FEDVIP to allow new categories of employees. Several commenters stated that expanding FEDVIP to more Federal employees will have a positive impact, including on FEDVIP rates, and will foster more competition in hiring and the ability to maintain a strong workforce in the Federal Government. They also stated this could foster greater competition with the private sector. One commenter stated that instead of opening up FEDVIP to more employees, OPM should consider requiring FEHB plans to include basic preventive dental care and eye exams/glasses as preventive care saves money. OPM declines this suggestion and notes that FEDVIP dental plans include preventive services such as routine services like exams and cleanings at no costs to enrollees when using in-network dentists.

Due to data limitations, OPM is unable to estimate the newly eligible populations' enrollment uptake in FEDVIP. While this population is currently eligible for FEHB, OPM cannot predict their uptake of dental and vision benefits based upon their uptake in health insurance benefits. However, due to the limited number of employees newly eligible to enroll in FEDVIP under this regulation, OPM does not anticipate a measurable impact on the overall FEDVIP risk pool.

We expect that the newly eligible population has a lower income compared to other Federal employees enrolled in FEDVIP. For instance, the current starting salary for entry-level wildland firefighters is $15 per hour. 3 Further, temporary Federal employees and certain Federal employees on seasonal and intermittent schedules are expected to work 130 hours per calendar month, for at least 90 days, to enroll for FEDVIP, which may mean less pay. There may be significant pent-up demand for services, at least initially, because it is likely that these individuals did not have dental or vision coverage. A 2020 review published in the Annual Review of Public Health found that individuals who are considered low income have a higher rate of insufficient or no dental coverage. 4 This leads to higher out-of-pocket costs for treatment, which is a deterrent for treatment. The same is true for vision care, with lack of access based on affordability, lack of transportation, and availability of optometrists, ophthalmologists, and other health professionals in close proximity to these individuals as some of the most common reasons explaining insufficient coverage. 5 This in turn correlates with higher dental, vision, and other health care needs.

While OPM does not anticipate a significant overall impact on the FEDVIP risk pool, in the case of firefighters and other emergency personnel, there is additional occupational risk, especially when it comes to vision but also overall health. To the extent this is true, the need to cover more costly dental and vision procedures could lead to a very slight increase in average premiums. This in turn may lead to a very small number of those enrolled to disenroll because they do not want to pay for the increased premium. If this occurs, the effect of an increase in disenrollment in the program would be negligible because current FEDVIP enrollment is 20 times larger than the newly eligible group. Any increase in premium from occupational risk may be counteracted by the likelihood that this newly eligible population is younger (especially pre-career postal employees), which correlates with lower age-related dental, vision, and health care risk.

Other than the small distributional effects described above, the net effect of expanding eligibility should be positive for society. Enrollees are responsible for paying the entire premium and should therefore enroll only to the extent that their expected benefit outweighs the cost (premium). It should increase dental, vision, and overall health for this population if needs that have been neglected due to lack of coverage are going to be addressed. This, in turn, correlates with fewer sick days and increased productivity. The expansion of coverage also promotes parity with other Federal employees in dental and vision access for employees with higher occupational risk, such as wildland firefighters and other emergency responders who may experience harmful impacts of fire and smoke on their vision and health.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. A regulatory impact analysis must be prepared for major rules with economically significant effects of $200 million or more in any one year. This rule has been designated as a “significant regulatory action,” under Executive Order 12866.

OPM certifies that this regulation will not have a significant economic impact on a substantial number of small entities.

Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act) (5 U.S.C. 801 et seq. ) requires rules (as defined in 5 U.S.C. 804) to be submitted to Congress before taking effect. The Office of Management and Budget's (OMB's) Office of Information and Regulatory Affairs has determined this is not a major rule as defined by the Congressional Review Act (5 U.S.C. 804(2)).

OPM examined this rule in accordance with Executive Order 13132, Federalism, and determined that it will not have any negative impact on the rights, roles and responsibilities of state, local, or tribal governments.

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.

Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid OMB Control Number.

This rule involves an OMB approved collection of information subject to the PRA for the FEDVIP Enrollment System, known as BENEFEDS, OMB Control Number: 3206-0272. The public reporting burden for this collection is estimated to average 7.19 minutes for a respondent to submit an enrollment, including time for reviewing education and support, but may not include time for reviewing a plan and specific benefits, which is a decrease in burden response due to increased system efficiency. The total burden hour estimate for this form is 76,828 hours. The systems of record notice for this collection is OPM/Central-26, “FEDVIP, FLTCIP, and FSAFEDS Records,” available at https://www.federalregister.gov/documents/2022/06/21/2022-13216/privacy-act-of-1974-system-of-records.

Accordingly, OPM amends 5 CFR part 894 as follows:

This action accompanies a DHS final rule, Optional Alternatives to the Physical Document Examination Associated with Employment Eligibility Verification (Form I-9), that appears in this edition of the Federal Register . Under the rule, the Secretary of Homeland Security (the Secretary) may, as an optional alternative to the in-person physical document examination (physical examination) method employers have followed as part of the Form I-9 process set forth in current regulations, authorize alternative documentation examination procedures. The Secretary may authorize alternative documentation examination procedures with respect to some or all employers as part of a pilot program, or upon a determination that such procedures offer an equivalent level of security, or as a temporary measure to address a public health emergency declared by the Secretary of Health and Human Services (pursuant to Section 319 of the Public Health Service Act) or a national emergency declared by the President (pursuant to Sections 201 and 301 of the National Emergencies Act). Consistent with that rule and following consideration of the public comments received on the notice of proposed rulemaking (NPRM) that preceded issuance of the final rule, this notice introduces the parameters of an alternative procedure to complete the Form I-9. 1

Separate from the Form I-9 flexibilities that were announced by DHS during the COVID-19 national emergency, 2 current regulations for the Form I-9 require that, within three business days after the first day of employment ( i.e., the first day of work in exchange for wages or other remuneration), employers must physically examine the documentation presented by new employees from the Lists of Acceptable Documents (“Form I-9 documents”), 3 or an acceptable receipt, 4 to ensure that the documentation presented reasonably appears to be genuine and to relate to the individual who presents it. See 8 CFR 274a.2(b)(1)(ii)(A), (b)(1)(vi). Employers must then complete Section 2, “Employer Review and Verification,” of the Form I-9. See 8 CFR 274a.2(b)(1)(ii)(B). If reverification is required, the employee or referred individual must present a document that shows continued employment authorization or a new grant of employment authorization. See 8 CFR 274a.2(b)(1)(vii). If the employer rehires an individual for whom it previously completed the Form I-9 and complied with the corresponding verification requirements, the employer may inspect the original Form I-9. See 8 CFR 274a.2(c). If the rehired employee's employment authorization, as noted on the original Form I-9, is expired when the individual is rehired, the employer must conduct reverification. See 8 CFR 274a.2(c). Employers cannot discriminate against employees based on citizenship, immigration status, or national origin during the Form I-9 process. See, e.g., 8 U.S.C. 1324b.

Currently, employers who physically examine the documentation presented by new employees may choose to make and retain copies or scans of the documentation presented by employees for the purpose of completing the Form I-9. However, employers that use E-Verify must make and retain copies of documentation presented by employees for List A of the Form I-9. If copies of an employee's Form I-9 documents are retained for reasons unrelated to E-Verify requirements, they must be retained for all employees, regardless of actual or perceived national origin, citizenship, or immigration status, or the employer may risk violating anti-discrimination laws. 5 Copies or electronic images of documents must be retrievable, consistent with DHS's standards on electronic retention, documentation, security, and electronic signatures for employers and employees, as specified in 8 CFR 274a.2(b)(3). Copies or electronic images of the employee's Form I-9 documents must be retained with the corresponding Form I-9 or with the employee's records according to the electronic records retention standards specified in 8 CFR 274a.2(b)(3) and be made available at the time of a Form I-9 audit by DHS.

DHS provides instructions and guidance to employers on how to complete the Form I-9 in the FormI-9 instructions and in other related guidance on the I-9 Central website, including additional guidance in the M-274, Handbook for Employers. 6

Under applicable regulations, employers or their authorized representatives must physically examine each original document from the employee (unless alternative procedures under 8 CFR 274a.2(b)(1)(ix) apply) to determine that the documentation reasonably appears to be genuine and to relate to the person presenting it. See 8 CFR 274a.2(b)(1)(ii)(A). Generally, the employer or employer's authorized representative examines these documents in the physical presence of the employee presenting them. 7

Physically examining identity and employment authorization documents offers important security benefits to enable employers to assess if the documents reasonably appear to be genuine and to relate to the individual who presents them. Employers who physically examine documents can touch and more clearly see identification security features like holograms and microprinting, as well as the card stock on which certain documents are printed.

Given the important benefits of physical inspection, DHS is proceeding with an alternative procedure, described more fully below, that does not require the physical examination of acceptable documents but instead includes additional requirements to offer at least an equivalent level of security, in exercise of the Secretary's authority at 8 CFR 274a.2(b)(1)(ix)(B).

At this time, the alternative procedure is available only to qualified employers, meaning those employers who are participants in good standing, in E-Verify. A participant in good standing in E-Verify is an employer that has enrolled in E-Verify with respect to all hiring sites in the United States that use the alternative procedure; is in compliance with all requirements of the E-Verify program, including but not limited to verifying the employment eligibility of newly hired employees in the United States; and continues to be a participant in good standing in E-Verify at any time during which the employer uses the alternative procedure. If a qualified employer chooses to offer the alternative procedure to new employees at an E-Verify hiring site, that employer must do so consistently for all employees at that site. However, a qualified employer may choose to offer the alternative procedure for remote hires only but continue to apply physical examination procedures to all employees who work onsite or in a hybrid capacity, so long as the employer does not adopt such a practice for a discriminatory purpose or treat employees differently based on their citizenship, immigration status, or national origin. 8 Qualified employers who use an alternative procedure with an employee must retain a clear and legible copy of all documents presented by the employee seeking to establish identity and employment eligibility for the Form I-9. 9

In part because DHS lacks data to assess the full impact of the Form I-9 COVID-19 flexibilities, DHS is limiting this alternative procedure to employers who are E-Verify participants in good standing. Such employers must confirm the identity and employment authorization of their newly hired employees by using E-Verify to electronically compare information from the Form I-9 to records available to DHS. Specifically, E-Verify electronically compares information entered by an employer from an employee's Form I-9, Employment Eligibility Verification, to records available to DHS and the SSA to confirm the validity of identity and employment authorization documents. E-Verify confirms List A documents that evidence identity and employment authorization, such as U.S. passports, Permanent Resident Cards, and Employment Authorization Documents (EADs), and electronically sends the photograph from the official record to the employer to compare with the photo on the document provided by the employee. E-Verify requires all cases to include the employee's Social Security number (SSN), and E-Verify electronically compares employer-entered data with SSA records. E-Verify requires that all List B identity documents presented by employees contain a photo and uses data sources available to DHS to electronically verify the identity information provided on most state-issued identification cards and driver's licenses. Ongoing user support is available in the form of webinars, E-Verify announcements communicated through E-Verify's robust distribution list, and a comprehensive resource web page. In addition to its normal roster of user training, E-Verify also grants enrolled employers access to training about employee rights and responsibilities. 10

Qualified employers who choose to use the alternative procedure must retain a clear and legible copy of all documents presented by the employee seeking to establish identity and employment eligibility for the Form I-9 under the alternative procedure. 11 Retained document copies allow DHS to assess the documents that were presented to, and remotely examined by, the employer in the event of an audit, and help to determine whether the documents examined by the employer reasonably appeared on their face to be genuine and to relate to the employee, that the employer has not discriminated against employees, and that the employer has complied with other Form I-9 requirements as required by statute (8 U.S.C. 1324a(b)(1)(A)(ii)) and regulation (8 CFR 274a.2(b)(1)(ii)(A).

Employers who enroll in E-Verify and any users who manage and create E-Verify cases must complete an E-Verify tutorial that includes fraud awareness and anti-discrimination training. The tutorial is free and accessible as part of the E-Verify enrollment process to any users who manage and create E-Verify cases. Anti-discrimination training provides an overview of how to avoid discrimination in the Form I-9 and E-Verify processes, such as by requesting more, different, or specific Form I-9 documents, or rejecting valid documentation, because of an employee's citizenship, immigration status, or national origin. The fraud awareness training provides an overview of fraud indicators in identity and employment eligibility documentation and describes how an employer can examine Form I-9 documentation at various angles to help identify common document anomalies. Employers can do this as part of a physical examination process or a remote examination process.

DHS has determined that the measures outlined in this notice, including (1) limiting participation to E-Verify participants in good standing; (2) expanding document retention requirements to include clear and legible copies of all presented documents for the Form I-9; (3) requiring training through E-Verify; and (4) conducting a live video interaction after the employee transmits a copy of the document(s) to the employer, offers at least an equivalent level of security as compared to physical document examination. These requirements appropriately mitigate the risk of undetected fraud or error and labor exploitation, position employers to ascertain whether the documents presented reasonably appear on their face to be genuine and to relate to the individual who presents them, ensure employers can confirm the validity of document information and therefore confirm employment eligibility via E-Verify, and provide additional accountability in the event of an audit. DHS believes these requirements appropriately address concerns about the potential for increased fraud in the Form I-9 process while allowing some employers to have access to this alternative procedure.

DHS currently lacks data on rates of fraud or error associated with use of the alternative procedure as it relates to the baseline physical inspection requirements. DHS has also been unable to determine whether any observable change in rates of fraud or error occurred during the COVID-19 flexibilities period. The requirements for the flexibilities first announced in March 2020 also differ from the requirements for this alternative procedure and are thus not directly comparable. Although DHS is confident that the alternative procedure offers at least an equivalent level of security, DHS will monitor and evaluate data and information from ICE Form I-9 audits after the implementation of this alternative procedure to assess any measurable impacts to system integrity (such as error or fraud rates). Based on this information, the Secretary may announce new procedures or requirements, or implement a pilot program to collect further data, or seek public comment thereon, as appropriate, in the Federal Register .

Within three business days of an employee's first day of employment, a qualified employer (or an authorized representative acting on such an employer's behalf, such as a third-party vendor) who chooses to use the alternative procedure must:

1. Examine copies (front and back, if the document is two-sided) of Form I-9 documents or an acceptable receipt  12 to ensure that the documentation presented reasonably appears to be genuine;

2. Conduct a live video interaction with the individual presenting the document(s) to ensure that the documentation reasonably appears to be genuine and related to the individual. The employee must first transmit a copy of the document(s) to the employer (per Step 1 above) and then present the same document(s) during the live video interaction;

3. Indicate on the Form I-9, by completing the corresponding box, that an alternative procedure was used to examine documentation to complete Section 2 or for reverification, as applicable;  13

4. Retain, consistent with applicable regulations, 14 a clear and legible copy of the documentation (front and back if the documentation is two-sided);  15 and

5. In the event of a Form I-9 audit or investigation by a relevant federal government official, make available the clear and legible copies of the identity and employment authorization documentation presented by the employee for document examination in connection with the employment eligibility verification process. 16

At this time, employers who are participants in good standing in E-Verify are qualified to use the alternative procedure. A participant in good standing in E-Verify in this context refers to an employer that has enrolled in E-Verify with respect to all hiring sites in the United States that use the alternative procedure; is in compliance with all requirements of the E-Verify program, including but not limited to verifying the employment eligibility of newly hired employees in the United States; and continues to be enrolled and a participant in good standing in E-Verify at any time during which the employer uses the alternative procedure.

Yes. Once enrolled in E-Verify, employers will be required to create a case for all newly hired employees, 17 whether or not the alternative procedure is used, at each hiring site that is enrolled in E-Verify, in accordance with the E-Verify Memorandum of Understanding.

E-Verify employers will be required to follow all applicable requirements, such as requirements imposed by the Federal Acquisition Regulation (FAR) E-Verify clause  18 for certain contracts or federal contractors. E-Verify employers must also avoid unlawful discrimination in the E-Verify process such as treating employees differently based on their citizenship, immigration status, or national origin, in order to avoid violating 8 U.S.C. 1324b and remain in compliance with E-Verify requirements.

Yes. Use of this alternative procedure is entirely optional. Nothing in the alternative procedure prevents qualified employers from physically examining documents for the Form I-9.

A qualified employer does not need to use the alternative procedure, but if a qualified employer chooses to offer the alternative procedure to some employees at an E-Verify hiring site, that employer must do so consistently for all employees at that site. However, a qualified employer may choose to offer the alternative procedure for remote hires only but continue to apply physical examination procedures to all employees who work onsite or in a hybrid capacity, so long as the employer does not adopt such a practice for a discriminatory purpose or treat employees differently based on a protected characteristic. 19 Under no circumstances can employers unlawfully discriminate, such as by deciding who is eligible for the alternative procedure based on a protected characteristic.

No. At this time, only employers who are participants in good standing in E-Verify are eligible to use the alternative procedure.

Yes, as noted above, qualified employers must indicate by completing the corresponding box, on the Form I-9, that an alternative procedure was used to examine documentation for either Section 2 or when conducting reverification.

Yes, as noted above, qualified employers applying the alternative procedure must retain clear and legible copies of all documents presented by the employee seeking to establish identity and employment eligibility for the Form I-9 and, in the event of an audit, provide access to these copies upon request. The alternative procedure retention requirement applies only to employees for whom the employer used the alternative procedure, not all employees of the employer.

Qualified employers may use the alternative procedure starting on August 1, 2023. Except as outlined in Question N below, employers cannot apply the alternative procedure to employees hired prior to the effective date of this notice. Other employers (those not enrolled in E-Verify) may do so after becoming a participant in good standing in E-Verify by enrolling and receiving the required training.

The alternative procedure described in this document does not expire. However, DHS may amend or cancel it upon the Secretary's determination that doing so is necessary to maintain an equivalent level of security or as a temporary measure to address a public health emergency declared by the Secretary of Health and Human Services pursuant to Section 319 of the Public Health Service Act, or a national emergency declared by the President pursuant to Sections 201 and 301 of the National Emergencies Act. The Secretary will announce any such changes to this alternative procedure, or seek public comment thereon, as appropriate, in the Federal Register .

No, qualified employers must allow employees who are unable or unwilling to submit documentation using the alternative procedure to submit documentation for physical examination. Nothing in the alternative procedure prevents an employer from physically examining documents when requested to do so by an employee.

To determine whether the documentation reasonably appears to be genuine, the qualified employer (or an authorized representative acting on the employer's behalf, such as a third-party vendor) must examine a copy of each document presented by the employee. In addition, the qualified employer must conduct a live video interaction with the employee who presents the document(s) to ensure that the documentation relates to the employee. The employee must first transmit a copy of the document(s) to the employer and then present the same document(s) during the live video interaction.

Yes, if certain conditions are met. Qualified employers that (1) were enrolled in E-Verify at the time they performed a remote examination of an employee's Form I-9 documentation for Section 2 or reverification while using the COVID-19 flexibilities, (2) created an E-Verify case for that employee (except for reverification), and (3) performed the remote inspection between March 20, 2020 and July 31, 2023, can use the alternative procedure to satisfy the required physical examination of the employee's documents for that Form I-9. Such employers should not create a new case in E-Verify.

All employers that use the alternative procedure instead of physical examination as described above must follow the steps of the alternative procedure and add “alternative procedure” with the date of examination ( i.e., the date the employer performed a live video interaction as required under the alternative procedure) to the Section 2 Additional Information field on the Form I-9 or in Section 3, as appropriate. 21 As noted in Question E above, under no circumstances can employers unlawfully discriminate, such as by deciding who is eligible for this use of the alternative procedure based on a protected characteristic.

Employers who were not enrolled in E-Verify at the time they initially performed a remote examination of an employee's documents ( i.e., within three business days of the employee's first day of employment) under the COVID-19 flexibilities between March 20, 2020 and July 31, 2023, are required to physically examine the employee's Form I-9 documents in the employee's physical presence. As previously announced, such physical examination must be completed no later than August 30, 2023. 22

The INA specifically authorizes DHS, IER, and DOL officers to inspect Forms I-9, including any copies of employee documents retained with the corresponding Form I-9. 23 All employers are subject to audits and investigations. DHS will monitor and evaluate data and information from ICE audits conducted to assess any measurable impacts to system integrity as between the employers that use the alternative procedure and those that continue with physical document inspection. Additionally, the final rule authorizes the Secretary to conduct a pilot program. DHS will evaluate all data and information collected through ICE audits after the implementation of this alternative procedure and future pilot programs with a continued goal of reducing unnecessary burdens and ensuring the security of any alternative procedures relative to physical document examination. The Secretary will announce any such pilot programs, new procedures, or changes to this alternative procedure, or seek public comment thereon, in the Federal Register .

As of August 1, 2023, employers should begin using Form I-9 with a version date of “(Edition: 08/01/2023)” to comply with their employment eligibility verification responsibilities. The version date is located in the bottom corner of the form. However, employers may continue using the prior version of Form I-9 (Edition: 10/21/2019) through October 31, 2023. If using the 10/21/2019 version of the Form I-9 for the alternative procedure, employers must indicate their use of the alternative procedure by writing “alternative procedure” in the Additional Information field in Section 2. After the grace period has elapsed, no later than November 1, 2023 employers must use the new Form I-9 (Edition: 08/01/2023) and indicate their use of the alternative procedure by completing the corresponding box in Section 2 or in the section corresponding to reverification (which is Supplement B in the August 1, 2023 edition of Form I-9), as appropriate.

After October 31, 2023, the prior version of Form I-9 will no longer be valid for use and will be obsolete. The public can download the new Form I-9 from www.uscis.gov/i-9. After October 31, 2023, employers who fail to use Form I-9 (Edition: 08/01/2023) may be subject to all applicable penalties under section 274A of the INA, 8 U.S.C. 1324a, as enforced by ICE.

Employers do not need to complete the new Form I-9 (Edition: 08/01/2023) for current employees who already have a properly completed Form I-9 on file, unless reverification applies. Unnecessary verification may violate the INA's anti-discrimination provision, section 274B of the INA, 8 U.S.C. 1324b, which is enforced by the Immigrant and Employee Rights Section (IER) in the Department of Justice's Civil Rights Division.

Employers may download the new Form I-9 (Edition: 08/01/2023) from the USCIS website at www.uscis.gov/i-9. Employers can order the paper Form I-9 at www.uscis.gov/forms/forms-by-mail. For more information, the public can contact the USCIS Contact Center at 800-375-5283 or visit USCIS' I-9 Central web page at www.uscis.gov/i-9central.

A Spanish-language version of the new Form I-9 is also available at www.uscis.gov/i-9 for use in Puerto Rico only.

The NRC is issuing a revision in the NRC's “Regulatory Guide” series. This series was developed to describe methods that are acceptable to the NRC staff for implementing specific parts of the agency's regulations, to explain techniques that the staff uses in evaluating specific issues or postulated events, and to describe information that the staff needs in its review of applications for permits and licenses.

The proposed Revision 4 to RG 1.152 was issued with a temporary identification of Draft Regulatory Guide, (DG)-1374 (ADAMS Accession No. ML23012A242). This revision (Revision 4) of the guide endorses, with some exceptions and clarifications, Institute of Electrical and Electronics Engineers (IEEE) Standard (Std) 7-4.3.2-2016, “IEEE Standard Criteria for Programmable Digital Devices in Safety Systems of Nuclear Power Generating Stations.” Specifically, this revision removes the previous SDOE guidance from this guide and instead endorses, with clarifications, the SDOE criteria within IEEE Std 7-4.3.2-2016. This revision also includes additional guidance for fault detection and self-diagnostics, if used, in digital instrumentation and controls systems. In addition, this revision endorses Annex D of IEEE Std 7-4.3.2-2016 and clarifies the applicability of the control of access guidance for safety-related PDDs.

The NRC published notice of the availability of DG-1374 in the Federal Register on March 10, 2023 (88 FR 14957), for a 30-day public comment period. The public comment period closed on April 10, 2023. Public comments on DG-1374 and the staff responses to the public comments are available in ADAMS under Accession No. ML23132A164.

As noted in the Federal Register on December 9, 2022 (87 FR 75671), this document is being published in the “Rules” section of the Federal Register to comply with publication requirements under 1 CFR chapter I.

This RG is a rule as defined in the Congressional Review Act (5 U.S.C. 801-808). However, the Office of Management and Budget has not found it to be a major rule as defined in the Congressional Review Act.

Issuance of RG 1.152, Revision 4, does not constitute backfitting as defined in § 50.109 of title 10 of the Code of Federal Regulations (10 CFR), “Backfitting,” and as described in NRC Management Directive (MD) 8.4, “Management of Backfitting, Forward Fitting, Issue Finality, and Information Requests”; affect the issue finality of an approval issued under 10 CFR part 52; or constitute forward fitting as defined in MD 8.4 because, as explained in this RG, licensees are not required to comply with the positions set forth in this RG.

A member of the public may, at any time, submit suggestions to the NRC for improvement of existing RGs or for the development of new RGs. Suggestions can be submitted on the NRC's public website at https://www.nrc.gov/reading-rm/doc-collections/reg-guides/contactus.html. Suggestions will be considered in future updates and enhancements to the “Regulatory Guide” series.

The NRC is issuing a new guide in the NRC's “Regulatory Guide” series. This series was developed to describe methods that are acceptable to the NRC staff for implementing specific parts of the agency's regulations, to explain techniques that the staff uses in evaluating specific issues or postulated events, and to describe information that the staff needs in its review of applications for permits and licenses.

RG 4.27 was issued with a temporary identification of Draft Regulatory Guide, DG-4029 (ADAMS Accession No. ML21049A181).

The NRC published a notice of the availability of DG-4029 in the Federal Register on June 24, 2021 (86 FR 33384) for a 45-day public comment period. The public comment period closed on August 9, 2021. Public comments on DG-4029 and the staff responses to the public comments are available under ADAMS under Accession No. ML23010A111.

As noted in the Federal Register on December 9, 2022 (87 FR 75671), this document is being published in the “Rules” section of the Federal Register to comply with publication requirements under 1 CFR chapter I.

This RG is not a rule as defined in the Congressional Review Act (5 U.S.C. 801-808).

Issuance of RG 4.27 would not constitute backfitting as that term is defined in section 50.109 of title 10 of the Code of Federal Regulations (10 CFR), “Backfitting,” and as described in NRC Management Directive (MD) 8.4, “Management of Backfitting, Forward Fitting, Issue Finality, and Information Requests”; constitute forward fitting as that term is defined and described in MD 8.4; or affect issue finality of any approval issued under 10 CFR part 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants.” As explained in RG 4.27, applicants and licensees are not required to comply with the positions set forth in RG 4.27.

A member of the public may, at any time, submit suggestions to the NRC for improvement of existing RGs or for the development of new RGs. Suggestions can be submitted on the NRC's public website at https://www.nrc.gov/reading-rm/doc-collections/reg-guides/ contactus.html. Suggestions will be considered in future updates and enhancements to the “Regulatory Guide” series.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all P&WC Model PW307D engines. The NPRM published in the Federal Register on May 11, 2023 (88 FR 30264). The NPRM was prompted by Transport Canada AD CF-2022-31, dated June 9, 2022, issued by Transport Canada, which is the aviation authority for Canada (referred to after this as the MCAI). The MCAI states that on March 18, 2020, an Airbus Model A321-231 airplane, powered by IAE Model V2533-A5 engines, experienced an uncontained HPT 1st-stage disk failure that resulted in an aborted takeoff and high-energy debris penetrating the engine cowling. In response to the March 2020 uncontained HPT 1st-stage disk failure, the FAA issued a series of ADs, including Emergency AD 2020-07-51, Amendment 39-21110 (85 FR 20402, April 13, 2020) (AD 2020-07-51). Since the FAA issued AD 2020-07-51, IAE determined that the failure of the V2533-A5 engine was due to an undetected subsurface material defect in the HPT 1st-stage disk that may affect the life of the part. In coordination with IAE, P&WC performed a records review and analysis of PW307A and PW307D engine parts made of similar material and identified two additional affected HPT 2nd-stage disks (S/Ns A004D8X1 and A004E9K3), installed on PW307D engines. These two additional HPT 2nd-stage disks may have a material defect which could reduce the life of the part. As such, the affected HPT 2nd-stage disks must be removed from service.

In the NPRM, the FAA proposed to require removing certain part-numbered HPT 2nd-stage disks from service and proposed to prohibit the installation of these HPT 2nd-stage disks onto any engine. The FAA is issuing this AD to address the unsafe condition on these products.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2023-0939.

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

These products have been approved by the aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA estimates that this AD affects 2 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's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it expands the availability of RNAV in Alaska and improves the efficient flow of air traffic within the National Airspace System by lessoning the dependency on ground-based navigation.

The FAA published a notice of proposed rulemaking for Docket No. FAA-2022-0265 in the Federal Register (87 FR 16672; March 24, 2022), establishing RNAV T-route T-386, in the vicinity of Fairbanks, AK, in support of a large and comprehensive T-route modernization project for the state of Alaska. Interested parties were invited to participate in this rulemaking effort by submitting comments on the proposal. No comments were received.

The NPRM misidentified the DEYEP, AK, point as a waypoint (WP) instead of a Fix. This rule corrects the error.

United States Area Navigation Routes are published in paragraph 6011 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11G, dated August 19, 2022, and effective September 15, 2022. FAA Order JO 7400.11G is publicly available as listed in the ADDRESSES section of this document. These amendments will be published in the next update to FAA Order JO 7400.11.

FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends 14 CFR part 71 by establishing RNAV route T-386 in the vicinity of Fairbanks, AK in support of a large and comprehensive T-route modernization project for the state of Alaska. The new route is described below.

T-386: T-386 extends from the Fairbanks, AK, (FAI) Very High Frequency (VHF) Omnidirectional Range and Tactical Air Navigation facility (VORTAC) to a new waypoint (WP), WEXIK, AK, WP, located over Circle City Airport, AK.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this airspace action of establishing RNAV route T-386 in the vicinity of Fairbanks, AK qualifies for categorical exclusion under the National Environmental Policy Act (42 U.S.C. 4321 et seq. ) and its implementing regulations at 40 CFR part 1500, and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5a, which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points), and paragraph 5-6.5i, which categorically excludes from further environmental review the establishment of new or revised air traffic control procedures conducted at 3,000 feet or more above ground level (AGL); procedures conducted below 3,000 feet AGL that do not cause traffic to be routinely routed over noise sensitive areas; modifications to currently approved procedures conducted below 3,000 feet AGL that do not significantly increase noise over noise sensitive areas; and increases in minimum altitudes and landing minima. As such, this action is not expected to result in any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the FAA has reviewed this action for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis. Accordingly, the FAA has determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment or environmental impact study.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it expands the availability of RNAV in Alaska and improves the efficient flow of air traffic within the National Airspace System (NAS) by lessening the dependency on ground-based navigation.

The FAA published a NPRM for Docket No. FAA-2022-0249 in the Federal Register (87 FR 16681; March 24, 2022), establishing an RNAV T-route in the vicinity of Sitka, AK in support of a large and comprehensive T-route modernization project for the state of Alaska. At that time, the proposed route was identified as T-383. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received.

The NPRM proposed to establish an RNAV T-route, identified as T-383, in Alaska. After the publication of the NPRM, the FAA realized that the number T-383 was already in use for another RNAV route in Minnesota. The existing RNAV T-route, T-383 was established in 2017 in Minnesota by a previous final rule (82 FR 27986; June 20, 2017). T-383 in Minnesota extends between the Gopher, MN (GEP), Very High Frequency (VHF) Omnidirectional Range and Tactical Air Navigational System (VORTAC) and the Baudette, MN (BDE), Distance Measuring Equipment (DME). To avoid duplicate route number designations in the NAS, and the confusion that would cause, the FAA corrects this error in the NPRM by identifying the Alaska route as T-481.

The route description of T-481 remains the same as was proposed in the March 24, 2022, NPRM. T-Route, T-383 in Minnesota is not affected by this action. It remains the same as currently published in FAA Order JO 7400.11G.

United States Area Navigation Routes are published in paragraph 6011 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11G, dated August 19, 2022, and effective September 15, 2022. FAA Order JO 7400.11G is publicly available as listed in the ADDRESSES section of this document. These amendments will be published in the next update to FAA Order JO 7400.11.

FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends 14 CFR part 71 by establishing RNAV T-route T-481, in the vicinity of Sitka, AK, in support of a large and comprehensive T-route modernization project in the state of Alaska. The new route is described below.

T-481: RNAV route T-481 extends between the Biorka Island, AK (BKA), VORTAC and the MAGNM, AK, waypoint (WP), located northwest of the Haines Airport, AK on the United States/Canada border.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this airspace action of establishing RNAV route T-481 in the vicinity of Sitka, AK qualifies for categorical exclusion under the National Environmental Policy Act (42 U.S.C. 4321 et seq. ) and its implementing regulations at 40 CFR part 1500, and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5a, which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points), and paragraph 5-6.5i, which categorically excludes from further environmental review the establishment of new or revised air traffic control procedures conducted at 3,000 feet or more above ground level (AGL); procedures conducted below 3,000 feet AGL that do not cause traffic to be routinely routed over noise sensitive areas; modifications to currently approved procedures conducted below 3,000 feet AGL that do not significantly increase noise over noise sensitive areas; and increases in minimum altitudes and landing minima. As such, this action is not expected to result in any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the FAA has reviewed this action for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis. Accordingly, the FAA has determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment or environmental impact study.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it expands the availability of RNAV in Alaska and improves the efficient flow of air traffic within the National Airspace System by lessening the dependency on ground-based navigation.

The FAA published a notice of proposed rulemaking for Docket No. FAA-2022-0182 in the Federal Register (87 FR 13237; March 9, 2022), amending RNAV route T-225 in the vicinity of Galena, AK, in support of a large and comprehensive T-route modernization project for the state of Alaska. Interested parties were invited to participate in this rulemaking effort by submitting comments on the proposal. No comments were received.

United States Area Navigation Routes are published in paragraph 6011 of FAA Order JO 7400.11G, dated August 19, 2022, and effective September 15, 2022, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11G, dated August 19, 2022, and effective September 15, 2022. FAA Order JO 7400.11G is publicly available as listed in the ADDRESSES section of this document. These amendments will be published in the next update to FAA Order JO 7400.11.

FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends 14 CFR part 71 by amending RNAV route T-225 in the vicinity of Galena, AK, in support of a large comprehensive T-route modernization project for the state of Alaska. The amendment is described below.

T-225: T-225 extends between the Hooper Bay, AK, Very High Frequency (VHF) Omnidirectional Range (VOR)/Distance Measuring Equipment (VOR/DME) and the Fairbanks, AK, VOR/Tactical Air Navigation (VORTAC) navigational aids (NAVAID). The KUHZE, AK and FECFO, AK, Fixes are added between the Galena, AK, VOR/DME and the Tanana, AK, VOR/DME NAVAIDs in the route since the Fixes are turn points along the route and must be included due to route description regulatory guidance. The unaffected portions of the route remain unchanged.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this airspace action of amending RNAV route T-225 in the vicinity of Galena, AK, qualifies for categorical exclusion under the National Environmental Policy Act (42 U.S.C. 4321 et seq. ) and its implementing regulations at 40 CFR part 1500, and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5a, which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points), and paragraph 5-6.5i, which categorically excludes from further environmental review the establishment of new or revised air traffic control procedures conducted at 3,000 feet or more above ground level (AGL); procedures conducted below 3,000 feet AGL that do not cause traffic to be routinely routed over noise sensitive areas; modifications to currently approved procedures conducted below 3,000 feet AGL that do not significantly increase noise over noise sensitive areas; and increases in minimum altitudes and landing minima. As such, this action is not expected to result in any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the FAA has reviewed this action for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis. Accordingly, the FAA has determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment or environmental impact study.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the route structure as necessary to preserve the safe and efficient flow of air traffic within the NAS.

The FAA published a NPRM for Docket No. FAA-2023-1276 in the Federal Register (88 FR 36976; June 6, 2023), proposing to amend six RNAV Q-routes in the eastern United States. This action supports the NEC ACR Optimization Project to improve the efficiency of the NAS. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received.

United States Area Navigation Routes (Q-routes) are published in paragraph 2006 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11G, dated August 19, 2022, and effective September 15, 2022. FAA Order JO 7400.11G is publicly available as listed in the ADDRESSES section of this document. These amendments will be published in the next update to FAA Order JO 7400.11.

FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends 14 CFR part 71 by amending RNAV routes Q-97, Q-117, Q-131, Q-167, Q-409, and Q-439 to enhance the efficiency of the NEC ACR Optimization Project, resolve issues of similar sounding waypoint (WP) names that may cause confusion in communications, and to remove points that are not required in the route descriptions.

Q-97 : Prior to this final rule, Q-97 extended from the TOVAR, FL, WP to the Presque Isle, ME (PQI), Very High Frequency (VHF) Omnidirectional Range/Distance Measuring Equipment (VOR/DME). This action removes the following WPs and one Fix from the route because they do not denote a turn of one degree or more: EBAYY, FL; ELMSZ, SC; YURCK, NC; YEASO, NC; KOHLS, NC; HEADI, NJ; SAILN, OA ( i.e., OA means Offshore Atlantic); BEEKN, ME; and the BRIGS, NJ, Fix. In addition, the DELAAY, MD, WP is moved, along the route, 11.5 nautical miles (NM) south of its current position. The move is required to deconflict New York arrival traffic from departures that are climbing southbound on RNAV routes Q-97 and Q-167. These changes do not affect the alignment of Q-97.

Q-117 : Prior to this final rule, Q-117 extended from the YLEEE, NC, WP to the SAWED, VA, WP. This action changes the name of the YLEEE, NC, WP to the PRONI, NC, WP to eliminate confusion with another similar sounding WP name. This has led to navigation system data entry errors. The PRONI, NC, WP has the same latitude/longitude coordinates as the YLEEE, NC, WP so the alignment of Q-117 remains unchanged. As amended, Q-117 extends from the PRONI, NC, WP to the SAWED, VA, WP.

Q-131 : Prior to this final rule, Q-131 extended from the ZILLS, NC, WP to the ZJAAY, MD, WP. To resolve confusion with similar sounding WP names, this action changes the name of the ZILLS, NC, WP to the WAALT, NC, WP; and changes the YLEEE, NC, WP to the PRONI, NC, WP. The new WP names retain the same latitude/longitude coordinates as the ones they replace. This action also removes the route segment from KALDA, VA, WP to the ZJAAY, MD, WP. That segment is being incorporated into RNAV route Q-101 in order to match the Q-route structure with preferred routing and air traffic control system automation, to improve the efficiency to the NAS. As amended, Q-131 extends from the WAALT, NC, WP to the KALDA, VA, WP.

Q-167 : Prior to this final rule, Q-167 extended from the ZJAAY, MD, WP to the SSOXS, MA, Fix. This action extends Q-167 12 NM southwestward from the ZJAAY, MD, WP to the KALDA, VA, WP in order to link with additional Q-routes. In addition, the following WPs are removed from the route description because they do not denote a turn of one degree or more: TOPRR, OA; SPDEY, OA; GRONC, NY, and NESTT, RI. The YAZUU, NJ, Fix, and the EMJAY, NJ, Fix are also removed for the same reason. The following Fixes in the Q-167 route description are reclassified as WPs to match the National Airspace System Resource (NASR) database updates: ZIZZI, NJ; RIFLE, NY; and HOFFI, NY. As amended, Q-167 extends from the KALDA, VA, WP to the SSOXS, MA, Fix.

Q-409 : Prior to this final rule, Q-409 extended from the ENEME, GA, WP to the WHITE, NJ, Fix. This action changes the name of the GNARO, DE, WP to the OYVAY, DE, WP due to word pronunciation issues causing confusion for flight crews during radio communications. In addition, the OYVAY, DE, WP is relocated 4.37 NM southwest of the GNARO, DE, WP position. The TRPOD, MD, WP is moved approximately 0.5 NM from its current position per air traffic control request. In addition, the JROSS, SC, WP and the DEEEZ, NC, WP are be removed from the route description because they do not denote a turn of one degree or more. As amended, Q-409 extends from the ENEME, GA, WP to the WHITE, NJ, Fix.

Q-439 : Prior to this final rule, Q-439 extended from the BRIGS, NJ, Fix to the Presque Isle, ME (PQI), VOR/DME. Air traffic control requested that Q-439 be extended southwest from the BRIGS, NJ, Fix to overlie a portion of existing RNAV route Q-445 from BRIGS to a new HOWYU, DE, WP. This adds the HOWYU, DE, WP as the new starting point for Q-439. The RADDS, DE, Fix, and the WNSTN, NJ, WP are added to the route description between the HOWYU, DE, WP and the MANTA, NJ, Fix.

The following Fixes are removed from the route description because they do not denote a turn of one degree or more: BRIGS, NJ; DRIFT, NJ; PLUME, NJ; SHERL, NJ; DUNDEE, NY; and FRIAR, ME. In addition, the RIFLE, NY, Fix is reclassified as a WP to match the NASR database updates. As amended, Q-439 extends from the HOWYU, DE, Fix to the Presque Isle, ME (PQI), VOR/DME.

Full descriptions of the amended routes are listed the amendments to part 71 set forth below. The FAA makes these changes in support of the NEC ACR Optimization Project to improve the efficiency of the NAS.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this airspace action of amending RNAV routes Q-97, Q-117, Q-131, Q-167, Q-409, and Q-439 qualifies for categorical exclusion under the National Environmental Policy Act (42 U.S.C. 4321 et seq. ) and its implementing regulations at 40 CFR part 1500, and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5a, which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points); and paragraph 5-6.5b, which categorically excludes from further environmental impact review “Actions regarding establishment of jet routes and Federal airways (see 14 CFR 71.15, Designation of jet routes and VOR Federal airways ) . . .”; and paragraph 5-6.5i, which categorically excludes from further environmental review the establishment of new or revised air traffic control procedures conducted at 3,000 feet or more above ground level (AGL); procedures conducted below 3,000 feet AGL that do not cause traffic to be routinely routed over noise sensitive areas; modifications to currently approved procedures conducted below 3,000 feet AGL that do not significantly increase noise over noise sensitive areas; and increases in minimum altitudes and landing minima. As such, this action is not expected to result in any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the FAA has reviewed this action for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis. Accordingly, the FAA has determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment or environmental impact study.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

This action prohibits certain flight operations in the Kabul FIR (OAKX) at altitudes below FL320 by all: U.S. air carriers; U.S. commercial operators; persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except when the operator of such aircraft is a foreign air carrier. The FAA finds this action necessary to address continuing significant hazards to persons and aircraft engaged in such flight operations due to the risk posed by violent extremist and militant activity and the lack of adequate risk mitigation capabilities to counter such activity.

However, the FAA has determined that U.S. civil overflights of the Kabul FIR (OAKX) at altitudes at and above FL320 may resume due to diminished risks to U.S. civil aviation operations at those altitudes. The FAA previously prohibited civil overflights of the Kabul FIR (OAKX) at all altitudes, except for the use of jet routes P500-G500, under Notice to Air Missions (NOTAM) KICZ A0029/21. Afghanistan has promulgated contingency measures based upon internationally recognized flight procedures and its published contingency plan. Afghanistan developed this contingency plan in consultation with the International Civil Aviation Organization (ICAO) and neighboring States. Consistent with other recently published flight prohibition SFARs, this action provides information about how to seek relief from this SFAR through the approval and exemption processes, as applicable. This rule expires on July 25, 2025.

The FAA is responsible for the safety of flight in the United States and for the safety of U.S. civil operators, U.S.-registered civil aircraft, and U.S.-certificated airmen throughout the world. Sections 106(f) and (g) of title 49, U.S. Code (U.S.C.), subtitle I, establish the FAA Administrator's authority to issue rules on aviation safety. Subtitle VII of title 49, Aviation Programs, describes in more detail the scope of the agency's authority. Section 40101(d)(1) provides that the Administrator shall consider, in the public interest, among other matters, assigning, maintaining, and enhancing safety and security as the highest priorities in air commerce. Section 40105(b)(1)(A) requires the Administrator to exercise this authority consistently with the obligations of the U.S. Government under international agreements.

The FAA is promulgating this rule under the authority described in 49 U.S.C. 44701, General Requirements. Under that section, the FAA is charged broadly with promoting safe flight of civil aircraft in air commerce by prescribing, among other things, regulations and minimum standards for practices, methods, and procedures that the Administrator finds necessary for safety in air commerce and national security. This regulation is within the scope of the FAA's authority because it prohibits the persons described in paragraph (a) of SFAR No. 119, § 91.1619, from conducting flight operations in the Kabul FIR (OAKX) at altitudes below FL320 due to the continuing significant hazards to the safety of U.S. civil flight operations at those altitudes, as described in the preamble to this final rule.

Section 553(b)(B) of title 5, U.S.C., 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.” Also, section 553(d) permits agencies, upon a finding of good cause, to issue rules with an effective date less than 30 days from the date of publication. In this instance, the FAA finds good cause to forgo notice and comment and the delayed effective date because they would be impracticable and contrary to the public interest.

Providing notice and the opportunity for the public to comment here would be impracticable. The FAA's flight prohibitions, and any amendments thereto, need to include appropriate boundaries that reflect the agency's current understanding of the risk environment for U.S. civil aviation. This allows the FAA to protect the safety of U.S. operators' aircraft and the lives of their passengers and crews without over-restricting or under-restricting U.S. operators' routing options. However, the risk environment for U.S. civil aviation in airspace managed by other countries with respect to the safety of flight is fluid in circumstances involving fighting, violent extremist and militant activity, or periods of heightened tensions, particularly where weapons capable of targeting or otherwise negatively affecting U.S. civil aviation are or may be present. This fluidity, and the potential for rapid changes in the risks to U.S. civil aviation, significantly limits how far in advance of a new or amended flight prohibition the FAA can usefully assess the risk environment. The delay that would be occasioned by providing an opportunity to comment on this action would significantly increase the risk that the resulting final action would not accurately reflect the current risks to U.S. civil aviation associated with the situation and thus would not establish boundaries for the flight prohibition commensurate with those risks.

While the FAA sought and responded to public comments, the boundaries of the area in which unacceptable risks to the safety of U.S. civil aviation existed might change due to: evolving military or political circumstances; violent extremist and militant group activity; the introduction, removal, or repositioning of more advanced anti-aircraft weapon systems; or other factors. As a result, if the situation improved while the FAA sought and responded to public comments, the rule the FAA finalized might be over-restrictive, unnecessarily limiting U.S. operators' routing options and potentially causing them to incur unnecessary additional fuel and operations-related costs, as well as potentially causing passengers to incur unnecessarily some costs attributed to their time. Conversely, if the situation deteriorated while the FAA sought and responded to public comments, the rule the FAA finalized might be under-restrictive, allowing U.S. civil aviation to continue operating in areas where unacceptable risks to their safety had developed. Such an outcome would endanger the safety of these aircraft, as well as their passengers and crews, exposing them to unacceptable risks of death, injury, and property damage that could occur if a U.S. operator's aircraft were shot down (or otherwise damaged) while operating in the Kabul FIR (OAKX) at altitudes below FL320.

Alternatively, if the FAA made changes to the area in which U.S. civil aviation operations would be prohibited between a notice of proposed rulemaking and a final rule due to changed conditions, the version of the rule the public commented on would no longer reflect the FAA's current assessment of the risk environment for U.S. civil aviation.

In addition, seeking comment would be contrary to the public interest because some of the rational basis for the rulemaking is based upon classified information and controlled unclassified information not authorized for public release. In order to meaningfully provide comment on a proposal, the public would need access to the basis for the agency's decision-making, which FAA cannot provide. Disclosing classified or controlled unclassified information in order to seek meaningful comment on the proposal would harm the public interest. Accordingly, FAA meaningfully seeking comment on the proposal is contrary to the public interest.

Therefore, providing notice and the opportunity for comment would be impracticable as it would hinder the FAA's ability to maintain appropriate flight prohibitions based on up-to-date risk assessments of the risks to the safety of U.S. civil aviation operations in airspace managed by other countries and contrary to the public interest as FAA cannot protect classified and controlled unclassified information and meaningfully seek public comment.

For the same reasons discussed above, the potential safety impacts and the need for prompt action on up-to-date information that is not public would make delaying the effective date impracticable and contrary to the public interest. For altitudes at and above FL320 in the Kabul FIR (OAKX), except for transiting overflights on jet routes P500-G500, any delay in the effective date of the rule would continue a prohibition on U.S. civil aviation operations at those altitudes that the FAA has determined is no longer needed for the safety of U.S. civil aviation and would thus unnecessarily restrict U.S. operators' routing options at those altitudes.

Accordingly, the FAA finds good cause exists to forgo notice and comment and any delay in the effective date for this rule.

The Taliban's takeover of Afghanistan and the ongoing threat of violent extremist organization (VEO) terrorist attacks, coupled with the coalition force withdrawal from Kabul International Airport (ICAO: OAKB), 1 resulted in a substantially degraded safety and security environment for U.S. civil aviation operations in the Kabul FIR (OAKX), including at Kabul International Airport (OAKB). The withdrawal of United States and coalition forces resulted in the removal of associated risk mitigation capabilities previously deployed at Kabul International Airport (OAKB). In addition, the absence of a functioning civil aviation authority and air navigation service provider created an unacceptable level of aviation safety risk for U.S. civil aviation operations in the Kabul FIR (OAKX) at all altitudes, with the exception of transiting overflight operations on jet routes P500-G500.

After the Taliban took over the country, the security environment in Afghanistan remained tenuous and complex and presented an enduring safety and security risk to U.S. civil aviation operating in the Kabul FIR (OAKX) at altitudes below FL260. 2 Thousands of individuals had been released from Afghan prisons, and various groups, including VEOs outside of Taliban control, had seized large quantities of military equipment. In addition, some VEOs operating in Afghanistan had demonstrated their capability and willingness to target civil aviation, as shown by attacks against Kabul International Airport (OAKB) during late August 2021 and previous instances of surface-to-air fire against U.S. Government-contracted aircraft over the course of the nearly 20-year U.S. presence in Afghanistan. On August 26, 2021, the Islamic State in Iraq and ash-Sham in Khorasan (ISIS-K) conducted a complex attack against Kabul International Airport (OAKB), killing hundreds, and, on August 30, 2021, ISIS-K employed indirect fire to target evacuation operations at the airport. Additionally, ISIS-K conducted an IED attack on a military security gate at Kabul International Airport (OAKB) on January 1, 2023, killing several people. Military and civil aircraft operating at lower altitudes had previously encountered weapons activity, and the FAA was concerned further incidents might occur from deliberate or inadvertent targeting that might endanger flight operations.

The FAA assessed that civil aircraft operating at lower altitudes might encounter direct or indirect surface-to-air fire threats, including small-arms fire, rocket-propelled grenades, and low-altitude anti-aircraft fire. The Taliban, ISIS-K, and other VEOs likely had access to weapons, including small arms, automatic machine guns, anti-aircraft artillery (AAA), anti-tank guided missiles (ATGMs), and unmanned aircraft systems (UAS), which posed a risk to aircraft during low-altitude flight operations, including the arrival and departure phases of flight, and while on the ground at targeted airports and airfields.

A limited threat also existed from the possible use of shoulder-fired man-portable air defense systems (MANPADS), which may be capable of reaching a maximum altitude of 25,000 feet above ground level (AGL). While the stockpile of MANPADS in Afghanistan was limited, there were VEOs seeking to acquire this capability. In the recent past, civil aircraft in Afghanistan had not been targeted with MANPADS. Military aircraft had been infrequently targeted with MANPADS since coalition operations in Afghanistan began in 2001. Although the FAA assessed it was unlikely the Taliban would target civil aviation in the Kabul FIR (OAKX) now that they had taken over the country, ISIS-K and some other VEOs operating in Afghanistan remained outside of Taliban control. The FAA assessed that ISIS-K and other VEOs had varying capabilities, including potentially having access to anti-aircraft weapons, including MANPADS.

In addition to the noted security risks, there was also an increased safety risk to U.S. civil aviation operations in the Kabul FIR (OAKX) at all altitudes. The Taliban takeover resulted in the lack of a functioning civil aviation authority and air navigation service provider. This included a lack of air traffic services (ATS) capabilities necessary to support en-route services for overflight operations without the implementation of appropriate contingency measures to enable safe flight operations under those conditions. In the immediate aftermath of the Taliban takeover, such contingency measures were not in place.

Taken together, these circumstances posed an unacceptable risk to the safety of U.S. civil aviation operations in the Kabul FIR (OAKX) at all altitudes, except for transiting overflight operations on jet routes P500-G500. To address these risks, on August 30, 2021, the FAA issued NOTAM KICZ A0029/21. This NOTAM prohibited, with certain limited exceptions, U.S. civil aviation operations in the Kabul FIR (OAKX) at all altitudes by all: U.S. air carriers; U.S. commercial operators; persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except when the operator of such aircraft is a foreign air carrier, due to the risk posed by violent extremist and militant activity, lack of adequate risk mitigation capabilities, and disruption to air traffic services. The NOTAM allowed U.S. civil aviation overflights to transit the Kabul FIR (OAKX) on jet routes P500-G500, as such operations are only in the Kabul FIR (OAKX) very briefly.

Following the Taliban takeover of Afghanistan, the ICAO Asia-Pacific Office made contact with Afghanistan's civil aviation authority and stood up a contingency coordination team (CCT) composed of Afghanistan and neighboring air navigation service providers, as well as International Air Transport Association (IATA) representation. Afghanistan's civil aviation authority and the CCT worked with neighboring air navigation service providers to establish a contingency plan for the safe resumption of civil overflights in the Kabul FIR (OAKX).

Subsequently, Afghanistan issued a series of NOTAMs delineating overflight procedures and established altitude blocks for specific categories of flight operations across various regions. The overflight procedures rely upon internationally-recognized traffic information by aircraft (TIBA) procedures, which pilots use in areas around the world where air traffic services are very limited or unavailable to maintain safe separation between aircraft. Consequently, the FAA has determined that U.S. civil aviation operations in the Kabul FIR (OAKX) may resume at altitudes at or above FL320 due to diminished risks to U.S. civil aviation operations at those altitudes.

However, the FAA continues to assess the situation in the Kabul FIR (OAKX) at altitudes below FL320 as being hazardous for U.S. civil aviation. Following the Taliban takeover of the country and the withdrawal of coalition forces, the Taliban have struggled to ensure security throughout Afghanistan. The Taliban face increasing attacks from ISIS-K, who have also threatened Western and international interests in the country. During the first half of 2022, ISIS-K conducted multiple attacks, in part in an effort to frustrate Taliban attempts to normalize relations with the international community. One incident of note took place in June 2022, in which ISIS-K attacked a bus serving Mazar-I-Sharif Airport (ICAO: OAMS), killing two airport workers.

The Taliban, ISIS-K, and other VEOs likely had and potentially maintain access to a variety of weapons, including small arms, automatic machine guns, AAA, ATGMs, and UAS, posing an ongoing risk to civil aircraft during low-altitude flight operations, including the arrival and departure phases of flight, and while on the ground at targeted airports and airfields. Possible VEO use of shoulder-fired MANPADS also remains a concern. While the stockpile of MANPADS in Afghanistan remains limited, VEOs continue to seek to acquire this capability. Some MANPADS may be capable of reaching a maximum altitude of 25,000 feet AGL; however, in the context of Afghanistan, the FAA must also account for the high altitude of some of the country's terrain. Allowing U.S. civil aviation operations in the Kabul FIR (OAKX) only at altitudes at or above FL320 accounts for risks associated with the capabilities of weapons systems potentially available to VEOs and the terrain under established international air routes in the Kabul FIR (OAKX). 3

In addition, VEOs active in Afghanistan have increased cross-border attacks into Pakistan, drawing Pakistani air strikes against targets in Afghanistan in response. In mid-April 2022, Pakistani airstrikes in eastern Afghanistan reportedly killed 47 civilians. Pakistan likely does not coordinate cross-border tactical military airstrikes with the Afghan civil aviation authority to de-conflict them with civil air traffic. Pakistan likely conducts such tactical military operations at altitudes below FL320.

Therefore, as a result of the remaining unacceptable risks to U.S. civil aviation operations in the Kabul FIR (OAKX) at altitudes below FL320 and the likelihood the risk concerns will endure, the FAA promulgates this final rule to incorporate a prohibition on U.S. civil aviation operations at those altitudes into the Code of Federal Regulations (CFR). The FAA will continue to monitor the situation and evaluate the extent to which U.S. civil operators and airmen might be able to operate safely in the Kabul FIR (OAKX) at altitudes below FL320. Amendments to SFAR No. 119, § 91.1619, could be appropriate if the risk to aviation safety and security changes. The FAA may amend or rescind SFAR No. 119, § 91.1619, as necessary, prior to its expiration date.

The FAA is also publishing the details concerning the approval and exemption processes in Sections V and VI of this preamble to enable interested persons to refer to this final rule for all relevant information about seeking relief from SFAR No. 119, § 91.1619.

In some instances, U.S. Government departments, agencies, or instrumentalities may need to engage U.S. civil aviation to support their activities in the Kabul FIR (OAKX) at altitudes below FL320. If a department, agency, or instrumentality of the U.S. Government determines that it has a critical need to engage any person described in paragraph (a) of SFAR No. 119, § 91.1619, including a U.S. air carrier or commercial operator, to transport civilian or military passengers or cargo or conduct other operations in the Kabul FIR (OAKX) at altitudes below FL320, that department, agency, or instrumentality may request the FAA to approve persons described in paragraph (a) of SFAR No. 119, § 91.1619, to conduct such operations.

The requesting U.S. Government department, agency, or instrumentality must submit the request for approval to the FAA's Associate Administrator for Aviation Safety in a letter signed by an appropriate senior official of the requesting department, agency, or instrumentality. 4 The FAA will not accept or consider requests for approval from anyone other than the requesting U.S. Government department, agency, or instrumentality. In addition, the senior official signing the letter requesting FAA approval must be sufficiently positioned within the requesting department, agency, or instrumentality to demonstrate that the organization's senior leadership supports the request for approval and is committed to taking all necessary steps to minimize aviation safety and security risks to the proposed flights. The senior official must also be in a position to (1) attest to the accuracy of all representations made to the FAA in the request for approval and (2) ensure that any support from the requesting U.S. Government department, agency, or instrumentality described in the request for approval is in fact brought to bear and is maintained over time. Unless justified by exigent circumstances, requesting U.S. Government departments, agencies, or instrumentalities must submit requests for approval to the FAA no less than 30 calendar days before the date on which the requesting department, agency, or instrumentality wishes the operator(s) to commence the proposed operation(s).

The requestor must send the request to the Associate Administrator for Aviation Safety, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591. Electronic submissions are acceptable, and the requesting entity may request that the FAA notify it electronically as to whether the FAA grants the request for approval. If a requestor wishes to make an electronic submission to the FAA, the requestor should contact the Air Transportation Division, Flight Standards Service, at (202) 267-8166 to obtain the appropriate email address. A single letter may request approval from the FAA for multiple persons described in SFAR No. 119, § 91.1619, or for multiple flight operations. To the extent known, the letter must identify the person(s) the requester expects the SFAR to cover on whose behalf the U.S. Government department, agency, or instrumentality seeks FAA approval, and it must describe—

• The proposed operation(s), including the nature of the mission being supported;

• The service the person(s) covered by the SFAR will provide;

• To the extent known, the specific locations in the Kabul FIR (OAKX) at altitudes below FL320 where the proposed operation(s) will occur, including, but not limited to, the flight path and altitude of the aircraft while it is operating in the Kabul FIR (OAKX) at altitudes below FL320 and the airports, airfields, or landing zones at which the aircraft will take off and land; and

• The method by which the requesting department, agency, or instrumentality will provide, or how the operator will otherwise obtain, current threat information and an explanation of how the operator will integrate this information into all phases of the proposed operations ( i.e., the pre-mission planning and briefing, in-flight, and post-flight phases).

The request for approval must also include a list of operators with whom the U.S. Government department, agency, or instrumentality requesting FAA approval has a current contract(s), grant(s), or cooperative agreement(s) (or its prime contractor has a subcontract(s)) for specific flight operations in the Kabul FIR (OAKX) at altitudes below FL320. The requestor may identify additional operators to the FAA at any time after the FAA issues its approval. Neither the operators listed in the original request nor any operators the requestor subsequently seeks to add to the approval may commence operations under the approval until the FAA issues them an Operations Specification (OpSpec) or Letter of Authorization (LOA), as appropriate, for operations in the Kabul FIR (OAKX) at altitudes below FL320. The approval conditions discussed below apply to all operators. Requestors should send updated lists to the email address they obtained from the Air Transportation Division by calling (202) 267-8166.

If an approval request includes classified information or controlled unclassified information not authorized for public release, requestors may contact Aviation Safety Inspector Bill Petrak for instructions on submitting it to the FAA. His contact information appears in the FOR FURTHER INFORMATION CONTACT section of this final rule.

FAA approval of an operation under SFAR No. 119, § 91.1619, does not relieve persons subject to this SFAR of the responsibility to comply with all other applicable FAA rules and regulations. Operators of civil aircraft must comply with the conditions of their certificates, OpSpecs, and LOAs, as applicable. Operators must also comply with all rules and regulations of other U.S. Government departments, agencies, or instrumentalities that may apply to the proposed operation(s), including, but not limited to, regulations issued by the Transportation Security Administration.

If the FAA approves the request, the FAA's Aviation Safety organization will send an approval letter to the requesting U.S. Government department, agency, or instrumentality informing it that the FAA's approval is subject to all of the following conditions:

(1) The approval will stipulate those procedures and conditions that limit, to the greatest degree possible, the risk to the operator while still allowing the operator to achieve its operational objectives.

(2) Before any approval takes effect, the operator must submit to the FAA:

(a) A written release of the U.S. Government from all damages, claims, and liabilities, including without limitation legal fees and expenses, relating to any event arising out of or related to the approved operations in the Kabul FIR (OAKX) at altitudes below FL320; and

(b) The operator's written agreement to indemnify the U.S. Government with respect to any and all third-party damages, claims, and liabilities, including without limitation legal fees and expenses, relating to any event arising out of or related to the approved operations in the Kabul FIR (OAKX) at altitudes below FL320.

(3) Other conditions the FAA may specify, including those the FAA might impose in OpSpecs or LOAs, as applicable.

The release and agreement to indemnify do not preclude an operator from raising a claim under an applicable non-premium war risk insurance policy the FAA issues under 49 U.S.C. chapter 443.

If the FAA approves the proposed operation(s), the FAA will issue an OpSpec or LOA, as applicable, to the operator(s) identified in the original request and any operators the requestor subsequently adds to the approval, authorizing them to conduct the approved operation(s). In addition, as stated in paragraph (3) of this section V.B., the FAA notes that it may include additional conditions beyond those contained in the approval letter in any OpSpec or LOA associated with a particular operator operating under this approval, as necessary in the interests of aviation safety. U.S. Government departments, agencies, and instrumentalities requesting FAA approval on behalf of entities with which they have a contract or subcontract, grant, or cooperative agreement should request a copy of the relevant OpSpec or LOA directly from the entity with which they have any of the foregoing types of arrangements, if desired.

Any operations not conducted under an approval the FAA issues through the approval process set forth previously may only occur in accordance with an exemption from SFAR No. 119, § 91.1619. A petition for exemption must comply with 14 CFR part 11. The FAA will consider whether exceptional circumstances exist beyond those the approval process described in the previous section contemplates. To determine whether a petition for exemption from the prohibition this SFAR establishes fulfills the standards described in 14 CFR 11.81, the FAA consistently finds necessary the following information:

• The proposed operation(s), including the nature of the operation;

• The service the person(s) covered by the SFAR will provide;

• The specific locations in the Kabul FIR (OAKX) at altitudes below FL320 where the proposed operation(s) will occur, including, but not limited to, the flight path and altitude of the aircraft while it is operating in the Kabul FIR (OAKX) at altitudes below FL320 and the airports, airfields, or landing zones at which the aircraft will take off and land;

• The method by which the operator will obtain current threat information and an explanation of how the operator will integrate this information into all phases of its proposed operations ( i.e., the pre-mission planning and briefing, in-flight, and post-flight phases); and

• The plans and procedures the operator will use to minimize the risks, identified in this preamble, to the proposed operations, to support the relief sought, and demonstrate that granting the exemption would not adversely affect safety or would provide a level of safety at least equal to that provided by this SFAR. The FAA has found comprehensive, organized plans and procedures of this nature to be helpful in facilitating the agency's safety evaluation of petitions for exemption from flight prohibition SFARs.

The FAA includes, as a condition of each such exemption it issues, a release and agreement to indemnify, as described previously.

The FAA recognizes that, with the support of the U.S. Government, the governments of other countries could plan operations that SFAR No. 119, § 91.1619, affects. While the FAA will not permit these operations through the approval process, the FAA will consider exemption requests for such operations on an expedited basis and in accordance with the order of preference set forth in paragraph (c) of SFAR No. 119, § 91.1619.

If a petition for exemption includes information that is sensitive for security reasons or proprietary information, requestors may contact Aviation Safety Inspector Bill Petrak for instructions on submitting it to the FAA. His contact information is listed in the FOR FURTHER INFORMATION CONTACT section of this final rule.

Congress authorized the FAA by statute to promote safe flight of civil aircraft in air commerce by prescribing, among other things, regulations and minimum standards for practices, methods, and procedures the Administrator finds necessary for safety in air commerce and national security. 49 U.S.C. 44701. Consistent with that mandate, the FAA is prohibiting certain persons from conducting flight operations in the Kabul FIR (OAKX) at altitudes below FL320 due to the continuing significant risks to the safety of U.S. civil flight operations. The purpose of this rule is to operate holistically in addressing a range of hazards and needs in the Kabul FIR (OAKX) at altitudes below FL320. However, the FAA recognizes that certain provisions focus on unique factors. Therefore, the FAA finds that the various provisions of this final rule are severable and able to operate functionally if severed from each other. In the event a court were to invalidate one or more of this final rule's unique provisions, the remaining provisions should stand, thus allowing the FAA to continue to fulfill its congressionally authorized role of promoting safe flight of civil aircraft in air commerce.

Federal agencies consider impacts of regulatory actions under a variety of executive orders and other requirements. First, Executive Order 12866 and Executive Order 13563, as amended by Executive Order 14094 (“Modernizing Regulatory Review”), direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as codified in 5 U.S.C. 603 et seq., requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act of 1979 (Pub. L. 96-39), as codified in 19 U.S.C. chapter 13, prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, the Trade Agreements Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), as codified in 2 U.S.C. chapter 25, requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or Tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this final rule.

In conducting these analyses, the FAA has determined this final rule has benefits that justify its costs. This rule is a significant regulatory action, as defined in section 3(f) of Executive Order 12866, as it raises novel policy issues contemplated under that Executive order. As 5 U.S.C. 553 does not require notice and comment for this final rule, 5 U.S.C. 603 and 604 do not require regulatory flexibility analyses regarding impacts on small entities. This rule will not create unnecessary obstacles to the foreign commerce of the United States. This rule will not impose an unfunded mandate on State, local, or Tribal governments, or on the private sector, by exceeding the threshold identified previously.

This rule prohibits U.S. civil flights in the Kabul FIR (OAKX) at altitudes below FL320 as a result of the continuing significant risks to U.S. civil aviation detailed in the preamble of this final rule. Overflights of the Kabul FIR (OAKX) may be conducted at altitudes at and above FL320. The FAA acknowledges this flight prohibition may result in additional costs to some U.S. operators, such as increased fuel costs and other operational-related costs, as well as some costs attributed to passenger time. However, the FAA expects the benefits of this action to exceed the costs because it will result in the avoidance of risks of fatalities, injuries, and property damage that could result from a U.S. operator's aircraft being shot down (or otherwise damaged) while operating in the Kabul FIR (OAKX) at altitudes below FL320.

The Regulatory Flexibility Act (RFA), in 5 U.S.C. 603, requires an agency to prepare an initial regulatory flexibility analysis describing impacts on small entities whenever 5 U.S.C. 553 or any other law requires an agency to publish a general notice of proposed rulemaking for any proposed rule. Similarly, 5 U.S.C. 604 requires an agency to prepare a final regulatory flexibility analysis when an agency issues a final rule under 5 U.S.C. 553 after that section or any other law requires publication of a general notice of proposed rulemaking. The FAA concludes good cause exists to forgo notice and comment and to not delay the effective date for this rule. As 5 U.S.C. 553 does not require notice and comment in this situation, 5 U.S.C. 603 and 604 similarly do not require regulatory flexibility analyses.

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

The FAA has assessed the potential effect of this final rule and determined that its purpose is to protect the safety of U.S. civil aviation from risks to their operations in the Kabul FIR (OAKX) at altitudes below FL320, a location outside the United States. Therefore, the rule complies with the Trade Agreements Act of 1979.

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and Tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $165 million in lieu of $100 million.

This final rule does not contain such a mandate. Therefore, the requirements of Title II of the Act do not apply.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires the FAA to consider the impact of paperwork and other information collection burdens it imposes on the public. The FAA has determined that no new requirement for information collection is associated with this final rule.

In keeping with U.S. obligations under the Convention on International Civil Aviation, the FAA's policy is to conform to ICAO Standards and Recommended Practices to the maximum extent practicable. The FAA has determined no ICAO Standards and Recommended Practices correspond to this regulation. The FAA finds this action is fully consistent with the obligations under 49 U.S.C. 40105(b)(1)(A) to ensure the FAA exercises its duties consistent with the obligations of the United States under international agreements.

While the FAA's flight prohibition does not apply to foreign air carriers, DOT codeshare authorizations prohibit foreign air carriers from carrying a U.S. codeshare partner's code on a flight segment that operates in airspace for which the FAA has issued a flight prohibition for U.S. civil aviation. In addition, foreign air carriers and other foreign operators may choose to avoid, or be advised or directed by their civil aviation authorities to avoid, airspace for which the FAA has issued a flight prohibition for U.S. civil aviation.

The FAA has analyzed this action under Executive Order 12114, Environmental Effects Abroad of Major Federal Actions, and DOT Order 5610.1C, Paragraph 16. Executive Order 12114 requires the FAA to be informed of environmental considerations and take those considerations into account when making decisions on major Federal actions that could have environmental impacts anywhere beyond the borders of the United States. The FAA has determined this action is exempt pursuant to Section 2-5(a)(i) of Executive Order 12114 because it does not have the potential for a significant effect on the environment outside the United States.

The FAA has determined that this action will not have a significant environmental effect abroad. In accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 8-6(c), the FAA has prepared a memorandum for the record stating the reason(s) for this determination and has placed it in the docket for this rulemaking.

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

The FAA analyzed this rule under Executive Order 13211. The agency has determined it is not a “significant energy action” under the Executive order and will not be likely to have a significant adverse effect on the supply, distribution, or use of energy.

Executive Order 13609 promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The FAA has analyzed this action under the policies and agency responsibilities of Executive Order 13609 and has determined that this action will have no effect on international regulatory cooperation.

Except for classified and controlled unclassified material not authorized for public release, all documents the FAA considered in developing this rule, including economic analyses and technical reports, may be accessed from the internet through the docket for this rulemaking.

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

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

The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (Pub. L. 104-121) (set forth as a note to 5 U.S.C. 601) requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document may contact its local FAA official, or the persons listed under the FOR FURTHER INFORMATION CONTACT heading at the beginning of the preamble. To find out more about SBREFA on the internet, visit http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations, as follows:

On December 15, 2016, USTR published a final rule comprehensively revising its FOIA regulation. See 81 FR 90715. This rule makes a technical change to § 2004.6 to align the USTR rule with the statute and Office of Information Policy guidance about the compelling circumstances under which an agency must grant expedited processing. 5 U.S.C. 552(a)(6)(E); https://www.justice.gov/oip/oip-guidance/guidance-agency-foia-regulations. More specifically, USTR is revising the instances in which a requester demonstrates a “compelling need” in § 2004.6(d)(2) to include when USTR determines that a failure to obtain requested records on an expedited basis could reasonably be expected to pose an imminent threat to the life or physical safety of an individual; or with respect to a request made by a person primarily engaged in disseminating information, there is urgency to inform the public concerning actual or alleged Federal Government activity.

USTR has considered the impact of the interim final rule and determined that it is not likely to have a significant economic impact on a substantial number of small business entities because it is applicable only to USTR's internal operations and legal obligations. See 5 U.S.C. 601 et seq.

The interim final rule does not contain any information collection requirement that requires the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

The interim final rule makes a technical, conforming amendment to a procedural rule applicable only to USTR's internal operations and legal obligations. Publication of a proposed rule is not required under 5 U.S.C. 553(b)(3)(A). For these reasons, USTR finds good cause for the rule to become effective upon publication. Because USTR values public input, it will accept comments on the interim final rule for 30 days, and will make changes to the final rule if warranted.

For the reasons stated in the preamble, USTR is amending chapter XX of title 15 of the Code of Federal Regulations as follows:

The regulations in 33 CFR 165.939 as listed in table 165.939 will be enforced for the safety zones identified below for the dates and times specified.

This notice of enforcement is issued under authority of 33 CFR 165.939 and 5 U.S.C. 552(a). Pursuant to 33 CFR 165.23, entry into, transiting, or anchoring within these safety zones during an enforcement period is prohibited unless authorized by the Captain of the Port Buffalo or their designated representative; designation need not be in writing. Those seeking permission to enter these safety zones may request permission from the Captain of the Port Buffalo via channel 16, VHF-FM. Vessels and persons granted permission to enter the safety zone shall obey the directions of the Captain of the Port Buffalo or their designated representative. While within a safety zone, all vessels shall operate at the minimum speed necessary to maintain a safe course.

In addition to this notice of enforcement in the Federal Register , the Coast Guard will provide the maritime community with advance notification of the enforcement periods via Broadcast Notice to Mariners or other suitable means. If the Captain of the Port Buffalo determines that the safety zone need not be enforced for the full duration stated in this notice, they may use a Broadcast Notice to Mariners to grant general permission to enter the respective safety zone.

This notification is being issued by the Coast Guard Sector Buffalo Prevention Department Head at the direction of the Captain of the Port.

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Federal Register Office's e-CFR site at https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1.

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2021-0172 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 September 25, 2023. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2021-0172, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets#express.

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

In the Federal Register of March 22, 2021 (86 FR 15162, FRL-10021-44), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11526) by International Specialty Products, an Ashland Inc. Company, 1005 US 202/206, Bridgewater, NJ 08807. The petition requested that 40 CFR 180.1130 be amended by establishing an exemption from the requirement of a tolerance for residues of N-(n-octyl)-2-pyrrolidone (CAS Reg. No. 2687-94-7) when used as an inert ingredient (solvent) in pesticide formulations containing prothioconazole at a maximum concentration of 15%. That document referenced a summary of the petition prepared by the petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the notice of filing.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. When making a safety determination for an exemption for the requirement of a tolerance FFDCA section 408(c)(2)(B) directs EPA to take into account the considerations in section 408(b)(2)(C) and (D). 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. . . .” Section 408(b)(2)(D) lists other factors for EPA's consideration in making safety determinations, e.g., the validity, completeness, and reliability of available data, nature of toxic effects, available information concerning the cumulative effects of the pesticide chemical and other substances with a common mechanism of toxicity, and available information concerning aggregate exposure levels to the pesticide chemical and other related substances, among other factors.

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no harm to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for N-(n-octyl)-2-pyrrolidone, including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with N-(n-octyl)-2-pyrrolidone follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by N-(n-octyl)-2-pyrrolidone as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

N-(n-octyl)-2-pyrrolidone has low acute toxicity via the oral and dermal routes. N-(n-octyl)-2-pyrrolidone is considered extremely irritating to the eyes and skin and is a dermal sensitizer. No acute inhalation study was available in the database for N-(n-octyl)-2-pyrrolidone alone; however, a product containing N-(n-octyl)-2-pyrrolidone and prothioconazole showed low concern for acute inhalation toxicity.

Clinical signs of neurotoxicity ( e.g., increased salivation, hunched posture, abnormal gait, and lethargy) are the most sensitive and common effects observed throughout the database following repeated dosing. These effects were observed in a 28-day study in rats, 13-week study in dogs, and a developmental toxicity study in rats.

No carcinogenicity studies were available in the database for N-(n-octyl)-2-pyrrolidone. The Agency used a qualitative structure activity relationship (SAR) database, DEREK11, to determine if there were structural alerts for potential carcinogenicity for N-(n-octyl)-2-pyrrolidone. No structural alerts for carcinogenicity were identified for N-(n-octyl)-2-pyrrolidone. In the absence of any structural alerts and lack of mutagenicity in available mutagenicity and genotoxicity studies, N-(n-octyl)-2-pyrrolidone is not expected to be carcinogenic. The is no evidence of offspring susceptibility, reproduction toxicity, or teratogenicity in the available developmental toxicity study in rats and the 1-generation reproduction toxicity study in rats.

No immunotoxicity or neurotoxicity studies were available in the database for N-(n-octyl)-2-pyrrolidone. However, no evidence of immunotoxicity was observed in the available database, and the selected endpoints are protective of the neurotoxicity effects observed in the database.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.

A summary of the toxicological endpoints for N-(n-octyl)-2-pyrrolidone used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to N-(n-octyl)-2-pyrrolidone, EPA considered exposure under the proposed exemption from the requirement of a tolerance and existing food uses. Dietary exposure may also occur from non-pesticidal uses but no reliable information is available for non-pesticidal exposures. Therefore, EPA assessed dietary exposures from pesticidal uses of N-(n-octyl)-2-pyrrolidone only. EPA assessed dietary exposures from N-(n-octyl)-2-pyrrolidone in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were not identified for N-(n-octyl)-2-pyrrolidone.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment using DEEM-FCID, Version 4.02, EPA used food consumption information from USDA's 2005-2010 NHANES/WWEIA. As to residue levels in food, no residue data were submitted for N-(n-octyl)-2-pyrrolidone. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Update to D361707: Dietary Exposure and Risk Assessments for the Inerts.” (12/21/2021), which can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2018-0090.

In the dietary exposure assessment, the Agency assumed that the residue level of the inert ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this assumption is that there would be similar rates of degradation (if any) between the active and inert ingredient and that the concentration of inert ingredient in the scenarios leading to these highest levels of tolerances would be no higher than the concentration of the active ingredient. While the current request is for use of N-(n-octyl)-2-pyrrolidone with the active ingredient prothioconazole at a limit of 15% in pesticide formulations, there are already existing food uses with other active ingredients up to 20% in pesticide formulations. In order to cover all possible exposure, the dietary exposure assessment utilized the 20% limitation in pesticide formulations except for all commodities except cotton, for which the assessment utilized a default 50% concentration.

The Agency believes the assumptions used to estimate dietary exposures lead to an extremely conservative assessment of dietary risk due to a series of compounded conservatisms. First, assuming that the level of residue for an inert ingredient is equal to the level of residue for the active ingredient will overstate exposure. The concentrations of active ingredient in agricultural products are generally at least 50 percent of the product and often can be much higher. Further, pesticide products rarely have a single inert ingredient; rather there is generally a combination of different inert ingredients used which additionally reduces the concentration of any single inert ingredient in the pesticide product in relation to that of the active ingredient.

Second, the conservatism of this methodology is compounded by EPA's decision to assume that, for each commodity, the active ingredient which will serve as a guide to the potential level of inert ingredient residues is the active ingredient with the highest tolerance level. This assumption overstates residue values because it would be highly unlikely, given the high number of inert ingredients, that a single inert ingredient or class of ingredients would be present at the level of the active ingredient in the highest tolerance for every commodity.

Finally, a third compounding conservatism is EPA's assumption that all foods contain the inert ingredient at the highest tolerance level. In other words, EPA assumed 100 percent of all foods are treated with the inert ingredient at the rate and manner necessary to produce the highest residue legally possible for an active ingredient. In summary, EPA chose a very conservative method for estimating what level of inert residue could be on food, then used this methodology to choose the highest possible residue that could be found on food and assumed that all food contained this residue. No consideration was given to potential degradation between harvest and consumption even though monitoring data shows that tolerance level residues are typically one to two orders of magnitude higher than actual residues in food when distributed in commerce.

Accordingly, although sufficient information to quantify actual residue levels in food is not available, the compounding of these conservative assumptions will lead to a significant exaggeration of actual exposures. EPA does not believe that this approach underestimates exposure in the absence of residue data.

2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for N-(n-octyl)-2-pyrrolidone, a conservative drinking water concentration value of 100 parts per billion (ppb) based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for N-(n-octyl)-2-pyrrolidone. These values were directly entered into the dietary exposure model.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., textiles [clothing and diapers], carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

N-(n-octyl)-2-pyrrolidone may be used as an inert ingredient in pesticide products that are registered for specific uses that may result in residential exposure ( e.g., products used in and around the home). Although there are non-pesticidal uses for N-(n-octyl)-2-pyrrolidone, no reliable exposure information is available for those uses. Therefore, a conservative residential exposure and risk assessment was completed for uses of N-(n-octyl)-2-pyrrolidone as a pesticide inert ingredient only. The Agency assessed pesticide products containing N-(n-octyl)-2-pyrrolidone using exposure scenarios that represent conservative residential handler exposure.

Short-term and intermediate-term residential exposure for adults combines high-end dermal and inhalation handler exposure from indoor hard surface, aerosol sprays and results in a margin of exposure (MOE) of 210. Short-term and intermediate-term high-end post-application dermal exposure from contact with mopping/wiping results in an MOE of 520. Short-term residential exposure for children includes total exposures associated with contact with indoor hard surface, aerosol sprays result in an MOE of 250. Because EPA's level of concern (LOC) for N-(n-octyl)-2-pyrrolidone is an MOE below 100, these MOEs are not of concern.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found N-(n-octyl)-2-pyrrolidone to share a common mechanism of toxicity with any other substances, and N-(n-octyl)-2-pyrrolidone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance exemption, therefore, EPA has assumed that N-(n-octyl)-2-pyrrolidone does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act safety factor. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

The Agency has concluded that the FQPA safety factor can be reduced to 1x for N-(n-octyl)-2-pyrrolidone for all exposure scenarios for the following reasons:

i. The toxicity database for N-(n-octyl)-2-pyrrolidone consists of a developmental toxicity study and 1-generation reproduction study. There is no evidence of effects on reproductive parameters in the 1-generation reproduction study, and the offspring effects observed in the database occurred at the same or higher doses than parental effects. Therefore, there is no evidence of increased susceptibility in the database.

ii. Additionally, the most sensitive endpoint selected, seen in the 13-week oral toxicity study on dogs, is protective of neurotoxic and all other effects observed in the database.

iii. There are no residual uncertainties identified in the exposure databases. As described earlier, EPA used worst case assumptions for the dietary food exposure assessment. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to N-(n-octyl)-2-pyrrolidone in drinking water. EPA used similarly conservative assumptions to assess residential post application exposure of children as well as incidental oral exposure of children 1-2. These assessments will not underestimate the exposure and risks posed by N-(n-octyl)-2-pyrrolidone.

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

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified, and no acute dietary endpoint was selected. Therefore, N-(n-octyl)-2-pyrrolidone is not expected to pose an acute risk.

2. Chronic risk. A chronic aggregate risk assessment takes into account chronic exposure estimates from dietary consumption of food and drinking water. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to N-(n-octyl)-2-pyrrolidone from food and water will utilize 45.9% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure.

3. Short-term and intermediate-term risk. Short- and intermediate term aggregate exposure takes into account short- and intermediate term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

N-(n-octyl)-2-pyrrolidone is currently used as an inert ingredient in pesticide products that are registered for uses that could result in short- and intermediate term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short- and intermediate term residential exposures to N-(n-octyl)-2-pyrrolidone.

Using the exposure assumptions described in this unit for short- and intermediate term exposures, EPA has concluded that the combined short- and intermediate term food, water, and residential exposures result in an aggregate MOE of 126 for adults. Adult residential pesticide exposure combines high-end dermal and inhalation handler exposure from indoor hard surface aerosol spray with high end post-application dermal exposure from indoor mopping/wiping. EPA has concluded that the combined short- and intermediate term food, water, and residential exposures result in an aggregate MOE of 121 for children. Children's residential pesticide exposure includes total exposures associated with contact with treated indoor surfaces (mopping/wiping; dermal and hand-to-mouth exposures). Because EPA's level of concern for N-(n-octyl)-2-pyrrolidone is an MOE of 100 or below, these MOEs are not of concern.

4. Aggregate cancer risk for U.S. population. Based on the absence of structural alerts for potential carcinogenicity in the database and the lack of mutagenicity concerns, N-(n-octyl)-2-pyrrolidone is not expected to pose a cancer risk to humans.

5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to N-(n-octyl)-2-pyrrolidone residues. More detailed information on this action can be found in the document titled “IN-11526; N-(n-octyl)-2-pyrrolidone: Human Health Risk and Ecological Effects Assessment of a Food Use Pesticide Inert Ingredient” in docket ID EPA-HQ-OPP-2021-0172.

An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of N-(n-octyl)-2-pyrrolidone in or on any food commodities. EPA is establishing a limitation on the amount of N-(n-octyl)-2-pyrrolidone that may be used in pesticide formulations. This limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. 136 et seq. EPA will not register any prothioconazole pesticide formulation for food use that exceeds 15% N-(n-octyl)-2-pyrrolidone in the final pesticide formulation.

Therefore, an exemption from the requirement of a tolerance is established for residues of N-(n-octyl)-2-pyrrolidone (CAS Reg. No. 2687-94-7) when used as an inert ingredient (solvent) in pesticide formulations containing prothioconazole at a maximum concentration of 15% under 40 CFR 180.1130.

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

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

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

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

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

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Office of the Federal Register's e- CFR site at https://www.ecfr.gov/current/title-40.

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2022-0479 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 September 25, 2023. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2022-0479, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.

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

In the Federal Register of July 20, 2022 (87 FR 43231) (FRL-9410-03-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2F9002) from Bayer CropScience, 800 N Lindbergh Blvd., St. Louis, MO 63141. The petition requested that 40 CFR 180.653 be amended by revising tolerances for residues of indaziflam N -[(1R,2S)-2,3-dihydro-2,6-dimethyl-1 H -inden-1-yl]-6-(1-fluoroethyl)-1,3,5-triazine-2,4-diamine, including its metabolites and degradates, in or on the following raw agricultural commodities: Grass Forage, Fodder, and Hay Group 17, forage at 50 parts per million (ppm); Grass Forage, Fodder, and Hay Group 17, hay at 80 ppm; and livestock fat, meat, meat byproducts, milk and milk, fat at 0.1, 0.01, 0.3, 0.015, and 0.4 ppm respectively. (The notice of filing published on July 20, 2022, incorrectly identified the tolerance levels for meat byproducts as 0.30 ppm and for milk, fat as 0.04 ppm, rather than 0.3 ppm and 0.4 ppm as the petition requested.) That document referenced a summary of the petition, which is available in the docket, https://www.regulations.gov. No comments were received in response to the July 20, 2022, notice of filing.

EPA is establishing one tolerance at a different level than requested by the petitioner. The reason for this change is explained in Unit IV.C. In addition, EPA is not revising the established tolerances for meat (i.e., Cattle, meat; Goat, meat; Horse, meat; and Sheep, meat) because the revised anticipated residues remain lower than the current tolerance level (0.01 ppm).

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 indaziflam including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with indaziflam follows.

In an effort to streamline its publications in the Federal Register, EPA is not reprinting sections that repeat what has been previously published for tolerance rulemakings for the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemakings, and EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking.

EPA has previously published tolerance rulemakings for indaziflam in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to indaziflam and established tolerances for residues of that chemical. EPA is incorporating previously published sections from these rulemakings as described further in this rulemaking, as they remain unchanged.

Toxicological profile. For a discussion of the Toxicological Profile of indaziflam, see Unit III.A. of the indaziflam tolerance rulemaking published in the Federal Register of October 10, 2019 (84 FR 54510) (FRL-9999-70).

Toxicological points of departure/Levels of concern. For a summary of the Toxicological Points of Departure/Levels of Concern for indaziflam used for human health risk assessment, please reference Unit III.B. of the October 10, 2019, rulemaking.

Exposure assessment. EPA's dietary exposure assessments have been updated to include the additional exposure from the proposed removal of the grass forage grazing restriction and the grass hay cutting restriction from certain indaziflam product labels, resulting in increased associated residues on animal commodities. The acute and chronic (food and drinking water) dietary exposure assessments in support of the proposed label amendments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 4.02. This software uses 2005-2010 food consumption data from the United States Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). The unrefined acute and chronic dietary exposure assessments assumed 100 percent crop treated (PCT), tolerance-level residues for all crops, and maximum anticipated residues to address all residues of concern in ruminant commodities.

Drinking water and non-occupational exposures. The drinking water numbers have not changed as a result of the proposed removal of the grass forage grazing restriction and the grass hay cutting restriction. For a detailed summary of the drinking water analysis for indaziflam used for the human health risk assessment, please reference Unit III.C.2. of the October 10, 2019, rulemaking.

Indaziflam is currently registered for the following uses that could result in residential exposures: turf, gardens, and trees. While there are no proposed residential uses in the current action, EPA's residential (non-occupational) exposure and risk assessment has been revised since the October 10, 2019, rulemaking. The following exposure estimates are used in the aggregate assessment for indaziflam because they are the most conservative of the residential handler and post-application scenarios. The residential exposure for children 1 to <2 years old is combined dermal and incidental oral (hand-to-mouth) exposure to turf (i.e., recreational premises/areas) applications via high contact lawn activities. The residential exposure for children 6 to <11 years old is dermal exposure to turf applications via golfing activities and for adults is combined dermal and inhalation exposure from handling indaziflam via ready-to-use (RTU) trigger spray bottle applications. None of the residential exposures are of concern.

Cumulative exposure. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to indaziflam and any other substances and indaziflam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that indaziflam has a common mechanism of toxicity with other substances.

Safety factor for infants and children. EPA continues to conclude that there are reliable data to support the reduction of the Food Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit III.D. of the October 10, 2019, rulemaking for a discussion of the Agency's rationale for that determination.

Aggregate risks and determination of safety. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing dietary exposure estimates to the acute population-adjusted dose (aPAD) and chronic population-adjusted dose (cPAD). Short-,intermediate-, and chronic-term aggregate risks are evaluated by comparing the estimated total food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure (MOE) exists.

Acute dietary (food and drinking water) risks are below the Agency's level of concern of 100% of the aPAD; they are 21% for all infants (<1 year old), the subgroup with the highest exposure. Chronic dietary (food and drinking water) risks are below the Agency's level of concern of 100% of the cPAD; they are 15% of the cPAD for the children 1 to 2 years old, the group with the highest exposure.

EPA aggregated short-term exposure to indaziflam based on the residential and dietary routes of exposure. The short-term aggregate MOEs were 360 for adults; 5,100 for children 6 to <11 years old; and 540 for children 1 to <2 years old. These values do not exceed the level of concern, which is an MOE below 100, so the risk estimates are not of concern. Acute and chronic aggregate risks are equivalent to the acute and chronic dietary risks and are not of concern. Indaziflam is not registered for any use patterns that would result in intermediate-term residential exposure, so intermediate-term aggregate risk is the same as the chronic dietary risk and is not of concern.

Based on the lack of evidence of carcinogenicity or genotoxicity, indaziflam is classified as “not likely to be carcinogenic to humans”. Therefore, EPA does not expect indaziflam to pose a cancer risk from aggregate exposure.

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 indaziflam residues. More detailed information on this action can be found in the document titled “Indaziflam. Human Health Risk Assessment for the Removal of Forage Grazing and Hay Cutting Intervals for Pastures, Rangeland, Natural Areas, and Grazed Non-Crop Areas, and the Increased Application Rate to Rights-of-Way” in docket ID EPA-HQ-OPP-2022-0479.

For a discussion of the available analytical enforcement method, see Unit IV.A. of the indaziflam tolerance rulemaking published in the Federal Register of June 24, 2020 (85 FR 37760) (FRL-10008-92).

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).

Codex Alimentarius has not established any Maximum Residue Limits (MRLs) for indaziflam.

EPA is amending the tolerance for residues of indaziflam in or on Grass, forage, fodder and hay, group 17, forage to 40 ppm rather than at 50 ppm as proposed by the petitioner. Both EPA and the petitioner entered the proportioned grass forage residue data into the Organization for Economic Development and Cooperation (OECD) tolerance calculator. The difference between the proposed and recommended tolerance values is likely due to a difference in rounding.

Therefore, the established tolerances for residues of indaziflam in or on the following commodities are revised to these levels: Cattle, fat at 0.1 ppm; Cattle, meat byproducts at 0.3 ppm; Goat, fat at 0.1 ppm; Goat, meat byproducts at 0.3 ppm; Grass, forage, fodder and hay, group 17, forage at 40 ppm; Grass, forage, fodder and hay, group 17, hay at 80 ppm; Horse, fat at 0.1 ppm; Horse, meat byproducts at 0.3 ppm; Milk at 0.015 ppm; Milk, fat at 0.4 ppm; Sheep, fat at 0.1 ppm; and Sheep, meat byproducts at 0.3 ppm.

This action establishes tolerances 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 to 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 tolerances 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 1 as follows:

You may be potentially affected by this action if you manufacture (defined by statute to include import) or process asbestos, as defined for purposes of this TSCA rulemaking. The use of the term “manufacture” in this document encompasses “import,” and the term “manufacturer” encompasses “importer.” Any use of the term “asbestos” will apply to asbestos in bulk form, in an article and/or product, as an impurity, or as a component of a mixture. For a more thorough discussion of the subject asbestos types, please see Unit IV.A. of this document. You may also be potentially affected by this action if you manufacture (including import) or process other chemical substances or mixtures that contain asbestos, including as an impurity, whether or not those chemical substances or mixtures are on the TSCA Chemical Substance Inventory. The TSCA Chemical Substance Inventory contains all existing chemical substances—including those with CBI claims protecting their identity—manufactured, processed, or imported in the United States that do not qualify for an exemption or exclusion under TSCA.

This rule does not require reporting on substances that are excluded from the definition of “chemical substance” in TSCA section 3(2)(B). Those exclusions include, but are not limited to: Any pesticide (as defined by the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a pesticide; any food, food additive, drug, cosmetic, or device, as defined by the Federal Food, Drug, and Cosmetic Act, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic or device; tobacco or any tobacco product; any source material, special nuclear material, or byproduct material as such terms are defined in the Atomic Energy Act of 1954; and, any article the sale of which is subject to the tax imposed by section 4181 of the Internal Revenue Code of 1954. Substances which have been manufactured or imported for intended use as any food, food additive, drug, cosmetic, or device as defined by the Federal Food, Drug, and Cosmetic Act, are not chemical substances under TSCA.

The following list of North American Industry Classification System (NAICS) codes are provided to assist in determining whether this action might apply to you. This list is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities, which although the terms “business,” “company,” and “firm” can have different meanings in some contexts, all are used to describe entities regulated under this rule, may include entities identified in:

• NAICS code 2122—Metal Ore Mining.

• NAICS code 2123—Nonmetallic Mineral Mining and Quarrying.

• NAICS code 322—Paper Manufacturing.

• NAICS code 323—Printing and Related Support Activities.

• NAICS code 324121—Asphalt Paving Mixture and Block Manufacturing.

• NAICS code 325—Chemical Manufacturing.

• NAICS code 326—Plastics and Rubber Products Manufacturing.

• NAICS code 327—Nonmetallic Mineral Product Manufacturing.

• NAICS code 331—Primary Metal Manufacturing.

• NAICS code 332—Fabricated Metal Product Manufacturing.

• NAICS code 333—Machinery Manufacturing.

• NAICS code 334—Computer and Electronic Product Manufacturing.

• NAICS code 335—Electrical Equipment, Appliance, and Component Manufacturing.

• NAICS code 336—Transportation Equipment Manufacturing.

• NAICS code 337—Furniture and Related Products Manufacturing.

• NAICS code 339—Miscellaneous Manufacturing.

• NAICS code 42—Wholesale Trade.

• NAICS code 441—Motor Vehicle and Parts Dealers.

• NAICS code 444—Building Material and Garden Equipment and Supplies Dealers.

• NAICS code 445110—Supermarkets and Other Grocery Retailers (except Convenience Retailers).

• NAICS code 445131—Convenience Retailers.

• NAICS code 449—Furniture, Home Furnishings, Electronics, and Appliance Retailers.

• NAICS code 455—General Merchandise Retailers.

• NAICS code 456110—Pharmacies and Drug Retailers.

• NAICS code 4571—Gasoline Stations.

• NAICS code 459—Sporting Goods, Hobby, Musical Instrument, Book, and Miscellaneous Retailers.

• NAICS code 56221—Hazardous Waste Treatment and Disposal.

• NAICS code 562920—Materials Recovery Facilities.

You should carefully examine the regulatory text in this document to determine if your business is impacted by this rule. If you have any questions regarding the applicability of this action to a particular entity, consult the technical contact person listed under FOR FURTHER INFORMATION CONTACT .

EPA is taking this action under section 8(a)(1) of TSCA, 15 U.S.C. 2607(a)(1), which generally authorizes EPA to promulgate rules that require each person, other than small manufacturers (including importers) or processors, who manufactures (including import) or processes, or proposes to manufacture (including import) or process, the chemical substance identified in the rule, to maintain such records and submit such reports as the EPA Administrator may reasonably require.

Although TSCA section 8(a)(1) provides an express exemption for small manufacturers (including importers) and processors, TSCA section 8(a)(3) enables EPA to require small manufacturers (including importers) and processors to report under TSCA section 8(a)(1) with respect to a chemical substance that is the subject of a rule proposed or promulgated under TSCA sections 4, 5(b)(4), or 6, an order in effect under TSCA sections 4 or 5(e), a consent agreement under TSCA section 4, or relief that has been granted under a civil action under TSCA sections 5 or 7. Asbestos is subject to TSCA section 6 rulemaking under the Asbestos Ban and Phaseout rule of 1989 (Ref. 1). A portion of this rule was overturned in Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991), however, a portion remains. The remaining portion of EPA's 1989 asbestos ban and phaseout rule prohibits the manufacture, importation, processing, and distribution in commerce of: Commercial Paper, Corrugated Paper, Rollboard, Specialty Paper, Flooring Felt, and New Uses if they contain asbestos (the manufacture, importation or processing of which would be initiated for the first time after August 25, 1989) (40 CFR 763.160 et seq. ).

Thus, EPA is exercising its authority provided under TSCA section 8(a)(3)(A)(ii) to require small manufacturers (including importers) and processors of asbestos or asbestos-containing mixtures (other than Libby amphibole asbestos) to maintain records and submit reports. However, Libby amphibole asbestos is not subject to an applicable proposed or promulgated rule under TSCA sections 4, 5(b)(4) or 6, an order in effect under TSCA section 4 or 5(e) or a consent agreement under TSCA section 4, nor is it the subject of relief that has been granted under a civil action under TSCA section 5 or 7. Therefore, small manufacturers (including importers) and processors of Libby amphibole asbestos are exempt from this reporting and recordkeeping rule with respect to Libby amphibole asbestos; this exemption does not extend to other types of asbestos. Note that small manufacturers (including importers) and processors of types of asbestos found in Libby amphibole ( e.g., tremolite) are subject to this rule.

For a more thorough discussion of the one-time reporting requirements for small manufacturers (including importers) and processors, see Unit IV.B. EPA has set an annual sales threshold, in any calendar year from 2019 to 2022, when combined with those of their ultimate parent company (if any) of $500,000, below which manufacturers and processors are not subject to the requirements of this rulemaking ( i.e., the manufacturer/processor would need to report if its annual sales, combined with its parent company, was above $500,000 during 2019, 2020, 2021, and/or 2022).

TSCA section 8(a)(1)(A) also excludes from the scope of EPA's regulatory authority under that paragraph any manufacturer (including importer) or processor of “a chemical substance described in subparagraph (B)(ii).” TSCA section 8(a)(1)(B)(ii), in turn, provides EPA authority to require recordkeeping and reporting by each person (other than a small manufacturer [including importer] or processor) who manufactures (including imports) or processes, or proposes to manufacture (including import) or process, a chemical substance “in small quantities. . .solely for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, including any such research or analysis for the development of a product,” but only to the extent EPA determines the recordkeeping and/or reporting is necessary for the effective enforcement of TSCA. EPA is not requiring recordkeeping or reporting by persons who manufacture (including import) or process, or propose to manufacture (including import) or process, asbestos in small quantities solely for research or analysis for the development of a product as described in TSCA section 8(a)(1)(B)(ii). “ Small quantities solely for research and development ” is defined in 40 CFR 704.3 to mean “quantities of a chemical substance manufactured, imported, or processed or proposed to be manufactured, imported, or processed solely for research and development that are not greater than reasonably necessary for such purposes.”

TSCA section 14 imposes requirements for the assertion, substantiation, and review of information that is claimed as confidential under TSCA (also known as confidential business information or CBI). Some information submitted at the time of the reporting under this rule may be claimed as confidential.

EPA is requiring asbestos manufacturers (including importers) and processors to report to EPA certain information known to or reasonably ascertainable by those entities. For this action, the term “asbestos” includes the following types of asbestos as described in more detail in Unit IV.A. of this document:

• Asbestos—CASRN 1332-21-4;

• Chrysotile—CASRN 12001-29-5;

• Crocidolite—CASRN 12001-28-4;

• Amosite—CASRN 12172-73-5;

• Anthophyllite—CASRN 77536-67-5;

• Tremolite—CASRN 77536-68-6;

• Actinolite—CASRN 77536-66-4; and

• Libby amphibole asbestos—CASRN not applicable (mainly consisting of tremolite [CASRN 77536-68-6], winchite [CASRN 12425-92-2], and richterite [CASRN 17068-76-7]).

If a specific asbestos type is unknown, a submitter will provide information under the general asbestos form (CASRN 1332-21-4). See Unit II.B. for more information about what is considered asbestos.

The following is a brief list of the primary data requirements in this rule. These requirements are described in detail in Unit IV.

1. Asbestos domestic manufacturers (Asbestos Mine and Mill): The provisions in this rule require asbestos domestic manufacturers to provide the quantity manufactured of each asbestos type, activity for each asbestos type ( i.e., mining and/or milling), and employee exposure information associated with each activity. This includes situations in which asbestos is being mined or milled as an intentional component or as an impurity, such as in vermiculite, talc, and other substances.

2. Asbestos importers: The provisions in this rule require importers of asbestos to provide the quantity imported of each asbestos type, activity for each asbestos type, and employee exposure information associated with each activity. This includes importers of mixtures containing asbestos, articles containing asbestos, and impurities (in articles, bulk materials, or mixtures).

3. Asbestos processors: The provisions in this rule require processors of asbestos (including processors of mixtures or articles) to provide the quantity processed per asbestos type, activity for each asbestos type ( i.e., primary and/or secondary processing), and employee exposure information associated with each activity. This includes both primary processors and secondary processors of asbestos, as described in Units IV.F.3. and 4. This includes situations in which asbestos occurs as an impurity, such as in vermiculite, talc, and other substances.

The Agency is taking this action to obtain certain information known to or reasonably ascertainable by manufacturers (including importers) and processors of asbestos that EPA believes will help the Agency better understand the exposures and uses associated with asbestos, including asbestos in articles and as an impurity (in articles, bulk materials, or mixtures, and other substances), that fall under the scope of this rule. Reported information will be used by EPA and other Federal agencies in considering potential actions involving asbestos, including EPA's TSCA risk evaluation and risk management activities. Requiring reporting may also increase public access to this information, which improves information quality overall, and may help inform and improve compliance assurance and accountability, and drive industry innovation. This action is also subject to a settlement agreement, as discussed in Unit II.C.3. of this document. For a more thorough discussion of the TSCA risk evaluation and risk management process, please see Unit II.C.5. of this document.

EPA has prepared an Economic Analysis (EA) (Ref. 2) of the potential impacts associated with this rule. The primary purpose of this rule is to collect detailed data on asbestos uses and exposures. Reported information will be used by EPA and other Federal agencies in considering potential actions involving asbestos, including EPA's TSCA risk evaluation and risk management activities. EPA estimates that 186 to 1,044 firms may submit reports for 268 to 1,126 sites based on the manufacturing (including importing) or processing of asbestos, including mixtures, products, and articles containing asbestos, including as an impurity. More detail on these estimates and related assumptions and uncertainties are provided in the revised EA for the final rule (Ref. 2).

The industry is expected to incur one-time burdens and costs associated with rule familiarization, form completion, CBI claim substantiation, recordkeeping, and electronic reporting activities. Rule familiarization costs for reporting firms are estimated to require an average of 24 hours and $2,036 per firm. Where asbestos is intentionally manufactured or processed, the estimated average form completion burden and cost per site ranges from 12 hours and $1,243 to approximately 26 hours and $2,372, depending on the type of activities in which the respondent is engaged and the information known to or reasonably ascertainable by them. For articles where asbestos occurs as an impurity, the estimated average form completion burden and cost per site ranges from approximately 17 hours and $1,674 to about 39 hours and $3,451, again depending on the type of activities and the information that is known or reasonably ascertainable. CBI claim substantiation, recordkeeping, and electronic reporting activities are estimated to require approximately 4 hours and $347 per firm. Manufacturers and processors of articles who believe that asbestos may have been present as an impurity are also expected to incur one-time burdens and costs associated with rule familiarization and compliance determination that average approximately 67 hours and $4,703.

EPA estimates a total industry quantified burden of approximately 4.5 million hours, with a quantified total cost of approximately $319 million to $323 million.

EPA estimates that approximately 66,000 small firms will be affected by the rule. Of those small firms, 99.93 percent are expected to have cost impacts of less than 1% of annual revenues, 0.07 percent are expected to have impacts between 1-3%, and none are expected to have impacts of more than 3% of annual revenues. Costs to small businesses range from $4,430 to $11,273 per firm. Total costs to small entities are approximately $279 million to $283 million. The Agency is expected to incur a cost of approximately $654,000. The total social burden and cost are therefore estimated to be approximately 4.5 million hours and $320 million to $324 million, respectively (Ref. 2).

EPA did not attempt to quantify the benefits of this action. As discussed in the economic analysis, EPA expects that information supplied as a result of this rule will allow EPA to more effectively and expeditiously evaluate risks posed by asbestos and manage them. Further, requiring reporting may provide the benefit of increased public access to this information, which improves information quality overall, and may help inform and improve compliance assurance and accountability, and drive industry innovation. Asbestos is hazardous to human health. Ultimately, enhancing the risk evaluation process will have positive consequences for human health and the environment and may enable a more efficient allocation of EPA's and society's resources.

TSCA section 8(a)(1) generally authorizes EPA to promulgate rules that require entities, other than small manufacturers (including importers) or processors, who manufacture (including import) or process, or propose to manufacture (including import) or process, a chemical substance to maintain such records and submit such reports as the EPA Administrator may reasonably require.

Under TSCA section 8(a)(2), EPA may require reporting and recordkeeping of the following information, to the extent the information is known to or reasonably ascertainable by the submitter:

• The common or trade name, chemical identity and molecular structure of each chemical substance or mixture;

• Categories or proposed categories of use for each substance or mixture;

• Total amount of each substance or mixture manufactured (including imported) or processed, the amounts manufactured (including imported) or processed for each category of use, and reasonable estimates of the respective amounts to be manufactured (including imported) or processed for each of its categories of use or proposed categories of use;

• Descriptions of byproducts resulting from the manufacture (including import), processing, use, or disposal of each substance or mixture;

• All existing information concerning the environmental and health effects of each substance or mixture;

• The number of individuals exposed, and reasonable estimates of the number of individuals who will be exposed, to each substance or mixture in their places of employment and the duration of their exposure; and

• The manner or method of disposal of each substance or mixture, and any change in such manner or method.

Asbestos is one or more of a group of highly fibrous silicate minerals that readily separate into long, thin, strong fibers that have sufficient flexibility to be woven, are heat resistant and chemically inert, are electrical insulators, and are therefore suitable for uses where incombustible, nonconducting, or chemically-resistant materials are required.

Asbestos is a mineral fiber that occurs in rock and soil. Because of its fiber strength and heat resistance, asbestos has been used in a variety of building construction materials for insulation and as a fire retardant. Asbestos has also been used in a wide range of manufactured goods, mostly in building materials (roofing shingles, ceiling and floor tiles, paper products, and asbestos cement products), friction products (automobile clutch, brake, and transmission parts), heat-resistant fabrics, packaging, gaskets, and coatings (Ref. 3).

For purposes of this rule, EPA considers “asbestos” to include the asbestiform varieties included in the definition of asbestos in TSCA Title II (added to TSCA in 1986), section 202 and Libby amphibole asbestos. “Asbestos” is defined in TSCA Title II, section 202 as the asbestiform varieties of six fiber types—chrysotile (serpentine), crocidolite (riebeckite), amosite (cummingtonite-grunerite), anthophyllite, tremolite, or actinolite. The general CAS Registry Number (CASRN) of asbestos is 1332-21-4; this is the only asbestos type on the TSCA Inventory. However, CASRNs are also available for specific fiber types. See Unit IV.A.1. for additional discussion.

In addition, EPA is including reporting for Libby amphibole asbestos (mainly consisting of tremolite [CASRN 77536-68-6], winchite [CASRN 12425-92-2], and richterite [CASRN 17068-76-7]) in order to help determine if this particular type of asbestos continues to be manufactured (including imported) or processed in the United States. The term “Libby amphibole asbestos” is used in this document to refer to the naturally occurring mixture of amphibole mineral fibers of varying elemental composition (winchite, richterite, tremolite, etc.) that have been identified in the Rainy Creek complex near Libby, Montana (Ref. 4). EPA does not anticipate that there is ongoing manufacture (including import) or processing of the Libby amphibole asbestos, but to help confirm this understanding has included this substance in the scope of this rule.

EPA has determined reporting on Libby amphibole asbestos' component parts, winchite and richterite, which are not asbestos types but commonly comprise Libby amphibole asbestos samples, shall be included in the scope of this TSCA section 8(a)(1) data collection and be reported on individually in addition to reporting on Libby amphibole asbestos (Ref. 5). Any reporting on Libby amphibole asbestos will improve EPA's understanding of this substance and will inform risk evaluation activities involving asbestos.

Asbestos is a hazard to human health (Ref. 6). Some of the health effects caused by exposure to asbestos are:

• Lung cancer;

• Ovarian cancer;

• Laryngeal cancer;

• Mesothelioma, a cancer of the thin lining of the lung, chest and the abdomen and heart; and

• Respiratory effects ( e.g., asbestosis, non-malignant respiratory disease, deficits in pulmonary function, diffuse pleural thickening and pleural plaques).

In the TSCA Risk Evaluation for Asbestos Part I: Chrysotile Asbestos published in December 2020 (Ref. 6), EPA identified and evaluated the reasonably available information for chrysotile asbestos, focusing on inhalation exposures and cancer outcomes as the hazards of asbestos exposure are well-established (Ref. 7).

For a more thorough discussion on the asbestos types addressed by this rule, see Unit IV.A.1 of this document.

In 1982, EPA finalized a rule entitled: “Asbestos Reporting Requirements” (47 FR 33198, August 30, 1982) (TSH-FRL-2124-4), under the authority of TSCA section 8(a) that required one-time reporting to EPA by asbestos manufacturers, importers, and processors. The information sought included data on the quantities of asbestos used in making products, employee exposure data, and waste disposal and pollution control equipment data. Reported information was used by EPA and other Federal agencies in considering the regulation of asbestos.

The information gathered as a result of the 1982 data collection rule was used in the drafting of the 1989 rule entitled “Asbestos: Manufacture, Importation, Processing, and Distribution in Commerce Prohibitions” (54 FR 29460, July 12, 1989 (FRL-3476-2)). In that action, EPA used TSCA section 6 authority to ban most asbestos-containing products. However, most of the ban was overturned in 1991 by the Fifth Circuit Court of Appeals. Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991). As a result, the 1989 asbestos regulation only bans new uses of asbestos in products that would be initiated “for the first time” after 1989 and five other specific product types (40 CFR part 763, subpart I).

It has been more than 40 years since the 1982 rule was implemented, and EPA needs an updated data collection to better understand the universe of asbestos types in commerce and the specific entities presently manufacturing (including importing) and processing asbestos, including asbestos-containing products. This rule is modeled after the 1982 data collection but requires more detailed information from manufacturers (including importers) and processors in addition to information about asbestos as an impurity.

In limited circumstances, asbestos has been reported under the Chemical Data Reporting (CDR) rule (40 CFR part 711). The CDR rule requires manufacturers (including importers) to provide EPA with information on the production and use of chemicals in commerce (Ref. 8). Under CDR, naturally occurring substances (including asbestos), impurities, and chemical substances when imported as part of articles are exempted from reporting (Ref. 9). This final rule differs from the existing CDR universe of data collected as it: (a) is a one-time data collection as opposed to a reoccurring data collection; (b) requires reporting for naturally-occurring asbestos; (c) requires processors of asbestos to report ( i.e., sites manufacturing (including importing) and/or processing asbestos are subject to this rule); and (d) requires reporting by entities who are manufacturing (including importing), and/or processing asbestos and to whom the asbestos content ( i.e., asbestos type and presence, or asbestos type and quantity, if known) is known or reasonably ascertainable (see TSCA section 8(a)(2)). “Known to or reasonably ascertainable by” is defined at 40 CFR 704.3 to include “all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.” EPA acknowledges that it is possible that an importer, particularly an importer of articles containing asbestos, including as an impurity, may not have knowledge that they have imported asbestos and thus not report under this rule, even after they have conducted their due diligence under this reporting standard as described in this paragraph. Such an importer should document its activities to support any claims it might need to make related to due diligence. This rule also differs from CDR data collection as it applies to impurities and imported articles, both of which are exempted from CDR data collection (40 CFR 711.10(b) & (c)) (Ref. 9 and Ref. 10).

On September 27, 2018, and January 31, 2019, respectively, petitioners Asbestos Disease Awareness Organization et al. (ADAO) (Ref. 11), and Attorneys General from ten states and the District of Columbia (the States) (Ref. 12) submitted petitions under TSCA section 21 (15 U.S.C. 2620) requesting EPA to amend the CDR Rule in ways that petitioners asserted would increase reporting of asbestos. Both petitions sought to close alleged asbestos CDR reporting gaps (including immediate submission of asbestos reports), remove the naturally occurring and byproduct exemptions, lower the reporting threshold, require reporting by processors, and eliminate the ability to claim information as confidential, in order to maximize the information reported to aid the Agency in conducting the ongoing TSCA section 6 risk evaluation of asbestos and subsequent TCSA Section 6(a) risk management rule (see Unit II.C.5. for more information). EPA denied the petitions on December 21, 2018, and April 30, 2019, respectively, and issued associated explanations for the denials in the Federal Register on February 12, 2019 (84 FR 3396 (FRL-9988-56)), and May 8, 2019 (84 FR 20062 (FRL-9992-67)), respectively, asserting that the petitioners failed to demonstrate that it is necessary to amend the CDR rule. EPA's denial was also in part due to a timing issue with the asbestos risk evaluation.

Petitioners filed lawsuits on February 18, 2019, and June 28, 2019, respectively, in the U.S. District Court in the Northern District of California, reiterating concerns about the need to amend the CDR rule to increase asbestos reporting. Asbestos Disease Awareness Organization v. EPA, No. 19-CV-00871; State of California et al. v. EPA, No. 19-CV-03807. The cases were consolidated. On December 22, 2020, after full briefing and oral argument, the Court issued an opinion granting summary judgment to Plaintiffs and denying summary judgment to EPA.

Following the litigation, EPA reached an agreement with the Plaintiffs on June 7, 2021. The parties agreed that no later than nine months from the effective date of the agreement (Ref. 13), EPA would sign for publication in the Federal Register , a notice of proposed action to promulgate a rule pursuant to TSCA section 8(a), 15 U.S.C. 2607(a), for the maintenance of records and submission to EPA of reports by manufacturers (including importers) and processors of asbestos (including asbestos that is a component of a mixture), and articles containing asbestos (including as an impurity) that address the information-gathering deficiencies identified in the Court's Summary Judgment Order. Additionally, the parties agreed that no later than eighteen months from the effective date of the agreement (Ref. 13), EPA would sign for publication in the Federal Register a notice of final action regarding the proposed TSCA section 8(a) rule. Pursuant to the agreement between the parties, EPA notified Plaintiffs in November 2022 that EPA would miss the deadline to sign the final rule within eighteen months from the effective date of the agreement, and that it expected signature in late April 2023.

In 2019, EPA promulgated a SNUR (84 FR 17345, April 25, 2019 (FRL-9991-33)) for the manufacturing (including import) or processing of asbestos for use in adhesives, sealants, and roof and nonroof coatings; arc chutes; beater-add gaskets; cement products; extruded sealant tape and other tape; filler for acetylene cylinders; friction materials (with certain exceptions); high-grade electrical paper; millboard; missile liner; packings; pipeline wrap; reinforced plastics; roofing felt; separators in fuel cells and batteries; vinyl-asbestos floor tile; woven products; any other building material; and any other use of asbestos that was not already prohibited under TSCA or under evaluation in the TSCA Risk Evaluation for Asbestos Part 1: Chrysotile Asbestos.

Activities that were under evaluation in the TSCA Risk Evaluation for Asbestos Part 1: Chrysotile Asbestos were not subject to the SNUR since there was ongoing manufacturing (including importing) or processing for those uses. Those activities not subject to the SNUR were manufacturing (including importing) or processing for the use of chrysotile in asbestos diaphragms; sheet gaskets; oilfield brake blocks; aftermarket automotive brakes/linings; other vehicle friction products; and other gaskets. Because all the ongoing uses of asbestos identified in the SNUR were for chrysotile, any use of crocidolite, amosite, anthophyllite, tremolite, or actinolite would be considered a significant new use.

A person wishing to begin manufacturing, importing, or processing asbestos (including as part of an article) for a significant new use must first submit a Significant New Use Notice (SNUN) to EPA. Before any significant new use of asbestos begins, EPA must evaluate it for potential risks to health and the environment and take any necessary regulatory action, which may include a prohibition.

Pursuant to TSCA section 6(b)(4)(A), EPA conducts risk evaluations to determine whether a chemical substance presents unreasonable risk of injury to health or the environment, without consideration of costs or non-risk factors, including an unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant by the Agency, under the conditions of use. (15 U.S.C. 2605(b)(4)(A)).

EPA is developing the TSCA Risk Evaluation on asbestos in two parts. In December 2020, EPA released the TSCA Risk Evaluation for Asbestos Part 1: Chrysotile Asbestos (Ref. 6), which determined that chrysotile asbestos presents an unreasonable risk of injury to health based upon the following conditions of use: processing and industrial use of chrysotile asbestos diaphragms in the chlor-alkali industry; processing and industrial use of chrysotile asbestos-containing sheet gaskets in chemical production; industrial use and disposal of chrysotile asbestos-containing brake blocks in the oil industry; commercial use and disposal of aftermarket automotive chrysotile asbestos-containing brakes/linings; commercial use and disposal of other chrysotile asbestos-containing vehicle friction products; commercial use and disposal of other asbestos-containing gaskets; consumer use and disposal of aftermarket automotive chrysotile asbestos-containing brakes/linings; and consumer use and disposal of other asbestos-containing gaskets.

EPA initially focused the risk evaluation for asbestos on chrysotile asbestos as this is the only asbestos type that EPA believes is currently imported, processed, or distributed in the United States. EPA informed the public of this decision to focus on ongoing uses of asbestos and exclude legacy uses and associated disposals in the Scope of the Risk Evaluation for Asbestos document, published in June 2017 (Ref. 14). However, in late 2019, the court in Safer Chemicals, Healthy Families v. EPA, 943 F.3d 397, 426-27 (9th Cir. 2019) held that EPA's Risk Evaluation Rule (82 FR 33726, July 20, 2017 (FRL-9964-38)) should not have excluded “legacy uses” ( i.e., uses without ongoing or prospective manufacturing (including importing), processing, or distribution) or “associated disposals” ( i.e., future disposal of legacy uses) from the definition of conditions of use, although the court did uphold EPA's exclusion of “legacy disposals” ( i.e., past disposal). Following this court ruling, EPA continued development of the risk evaluation for ongoing uses of chrysotile asbestos and determined that the complete TSCA Risk Evaluation for Asbestos would be issued in two parts. The TSCA Risk Evaluation for Asbestos Part 1: Chrysotile Asbestos was released in December 2020, allowing the Agency to move into risk management for the unreasonable risk for ongoing uses of asbestos identified in Part 1.

EPA is currently conducting the TSCA Risk Evaluation for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos. EPA intends to include in Part 2 of the risk evaluation the legacy uses and associated disposal of asbestos. For the purposes of scoping and risk evaluation, EPA has explained that its evaluation of asbestos includes the six fiber types listed in TSCA Title II (added to TSCA in 1986), section 202 (chrysotile (serpentine), crocidolite (riebeckite), amosite (cummingtonite-grunerite), anthophyllite, tremolite, or actinolite) and Libby amphibole asbestos (with tremolite, winchite, and richterite constituents), as well as asbestos present as an impurity in other substances. EPA expects that the one-time data collected from this rule will be used in TSCA Risk Evaluation for Asbestos Part 2 and will also inform risk management actions for asbestos under TSCA section 6(a).

Reported information will be used by EPA and other Federal agencies in considering potential actions on asbestos, including EPA's TSCA risk evaluation and risk management activities. Reporting may provide EPA with baseline information needed to assess whether certain “conditions of use” of asbestos drive unreasonable risk to human health or the environment under TSCA section 6(b). EPA must consider reasonably available information as part of the risk evaluation process under TSCA section 6(b), and as part of any subsequent risk management rulemaking efforts under TSCA section 6(a). Reported information would be useful in the risk management stage because EPA would consider potential risk management actions taking into account relevant information obtained through this rulemaking. Understanding the health risks of asbestos and protecting the public, including potentially exposed or susceptible subpopulations, from these risks is a priority for EPA.

As part of the risk evaluation process under TSCA section 6(b), EPA must determine whether asbestos presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including unreasonable risk to relevant potentially exposed or susceptible subpopulations, under the conditions of use. EPA must also use scientific information and approaches in a manner that is consistent with the requirements in TSCA for the best available science, and ensure decisions are based on the weight of scientific evidence. See TSCA section 26(h) and (i), 15 U.S.C. 2625(h) and (i). In order to follow this framework, EPA will take into consideration reasonably available information to inform the TSCA Risk Evaluation for Asbestos Part 2. Data collected by this rule could help to fill potential data gaps that EPA may have for asbestos that could better inform the Part 2 risk evaluation. Following risk evaluation, TSCA mandates that EPA take action if the Agency determines that asbestos presents unreasonable risk of injury to health or the environment. EPA needs to ensure that sufficient information is reasonably available on the uses and trends of asbestos activities to develop a risk management rule that eliminates the unreasonable risk. The information collected in this rulemaking may be available to support the Part 2 risk evaluation, which is expected on or before December 1, 2024. Additionally, the information collected in this rulemaking will help inform any required risk management actions following the risk evaluation process.

For these reasons, EPA believes that the reporting and recordkeeping requirements in this rule are reasonable. See TSCA section 8(a)(1)(A).

EPA received 27 comments on the proposed rule (87 FR 27060, May 6, 2022 (FRL-8632-02-OCSPP)). Of these, seven comments, from certain industry stakeholders and ADAO, were in whole or in part requests to extend the comment period, which EPA denied. Three of the comments were generally supportive of the proposed rulemaking, with the remainder of the comments being generally adverse. The comments and EPA responses, as well as a more thorough summary of the comments received, are presented in the Response to Public Comments document (Ref. 15) that is available in the docket for this rulemaking and summarized in this unit.

The majority of comments on the proposed rule addressed the economic analysis EPA developed for the proposed rule, with the majority of commenters stating EPA largely underestimated the burden the proposed rule would impose. Commenters also suggested the need for EPA to consider a threshold exemption to reporting, for which nearly all industry groups expressed support; and wholly exempting asbestos as an impurity in articles and/or naturally occurring chemical substances.

After considering the public comments, EPA made the following changes to the EA and rulemaking that are discussed in this unit.

In response to comments received, in its revised EA for the final rule, EPA estimates the total number of sites subject to this rulemaking to be 67,647 to 68,505, inclusive of all potentially affected manufactures and processors subject to this rule, with 186 to 1,044 firms reporting for 268 to 1,126 sites (Ref. 2). This is an increase of 168 to 1,026 firms and 241 to 1,099 sites from the estimate for the proposed rule, which did not quantify the number of entities potentially affected due to the potential presence of asbestos as an impurity. EPA maintains that use categories where the manufacturing or processing of asbestos (including asbestos mixtures) or articles containing asbestos is intended, known, or reasonably foreseen include chlor-alkali plants, sheeting gasket manufacturing, oilfield brake blocks, and aftermarket brakes. In response to comments that the number of estimated entities affected in the proposed rule and EA is unrealistically or unjustifiably low, as well as identification of industries that would be likely subject to the rulemaking, EPA has updated its EA for this rulemaking to estimate the number of affected entities potentially reporting for asbestos as in impurity (including impurities present in articles), which were not quantified in the analysis for the proposed rule. Details on affected entities are provided in the revised EA, which is available in the public docket for this rulemaking (Ref. 2).

In the proposed rule, EPA was unable to determine the number of potential manufacturers (including importers) or processors of asbestos as an impurity in bulk materials or articles that would report due to a lack of information on the extent to which asbestos occurs as an impurity in bulk materials or articles. The Agency also recognized that the universe of entities that would be subject to the rule if finalized as proposed—particularly with regard to rule familiarization—might be larger than what the draft EA had estimated. Thus, EPA specifically sought public comment on the number of manufacturers (including importers) and processors who may be subject to the proposed rule due to the presence of asbestos impurities in their products, and on the related burden and cost for reporting. EPA sought comment on ways to minimize reporting burden on small manufacturers and processors pursuant to TSCA section 8(a)(5)(B), such as providing a reporting threshold based on factors including production volume or asbestos concentration. EPA received public comment providing additional information on instances of asbestos being present in very low concentrations in various products. Therefore, a threshold based on asbestos concentration or quantity would not satisfy EPA's data needs.

After careful consideration of comments received on the number of firms that would potentially be subject to the rule (EPA-HQ-OPPT-2021-0357-0052, EPA-HQ-OPPT-2021-0357-0049), EPA has, based in part on specific comment and in part on its judgment, revised its EA for the final rule to estimate the number of firms that may be subject to the rule because they potentially manufacture or process products containing asbestos as an impurity, and has revised the total estimated burden based on that number. At the time of the proposal, EPA estimated that 27 facilities that were intentionally manufacturing or processing products containing asbestos would be affected by the rule at an estimated cost of $99,496 (with a total social cost of $659,839 estimated for the rulemaking, including EPA burden). With the inclusion of facilities that manufacture or process products containing asbestos as an impurity, EPA estimates that the rule will affect 96,687 to 97,545 facilities (of which an estimated 268 to 1,126 will submit reports) at an estimated cost of approximately $319 million to $323 million (with a total social cost estimated to be approximately $320 million to $324 million). More detail on these estimates and related assumptions and uncertainties are provided in the revised EA for the final rule (Ref. 2). The increase in estimated total cost from that in the proposed rule is not driven by an increased compliance or reporting cost per entity, but is the result of identifying the larger number of entities that will spend time determining whether they must report for asbestos present as an impurity. Despite the increased social cost, EPA estimates that for products where asbestos is used intentionally, the estimated average burden and cost per site will range from approximately 12 hours and $1,243 (for secondary processors or importers of articles or mixtures using Form A) to 26 hours and $2,372 (for bulk importers and primary processors using Form B). For products where asbestos occurs as an impurity, the estimated average burden and cost per site will range from approximately 17 hours and $1,674 (for secondary processors or importers of articles or mixtures using Form A) to 39 hours and $3,451 (for bulk importers and primary processors using Form B) and 244 sites are estimated to submit reports. The increased estimate of social costs in the EA of the final rule reflects the result of the notice and comment process. These costs reflect an updated analysis of entities subject to the rule, based on public comments (EPA-HQ-OPPT-2021-0357-0052, EPA-HQ-OPPT-2021-0357-0049) received on the proposed rule, rather than substantive changes to proposed reporting requirements.

TSCA Section 8(a)(5)(B) requires EPA to minimize, to the extent feasible, the cost of compliance for small manufacturers and processors, and EPA recognizes that it can alleviate some burden while continuing to address information needs and ensure that the information being sought is reported, per the requirements under Section 8(a)(5)(C). While all known or reasonably ascertainable information on asbestos is of interest to EPA, the Agency recognizes that ultimate parent companies with comparatively low sales may not have information on asbestos to submit to EPA and such information is anticipated to be of much lesser magnitude than submissions provided by entities with greater sales. EPA received comment (EPA-HQ-OPPT-2021-0357-0046) that large businesses are more likely than small businesses to have resources dedicated to collecting information and tracking supply chains. Small businesses are also more likely to have fewer products or COUs on which to report. Viewed together, these factors warrant alleviating the burden of rule familiarization and reporting on some small businesses for purposes of this rule. Further, EPA does not have information to suggest that any of the smallest entities would have reasonably ascertainable asbestos information on which to base their reporting or that they would have information on unique COUs. Such entities, then, would incur rule familiarization and compliance determination burden without providing the benefit of submitting data on asbestos. Thus, providing a sales threshold alleviates the burden of this rule from entities least positioned to report to the rule. EPA, therefore, has decided to set an annual sales threshold, when combined with those of their ultimate parent company (if any), of $500,000, below which manufacturers and processors are not subject to the requirements of this rulemaking. This figure represents a sales threshold where most entities throughout industry sectors that might report on manufacture or processing of asbestos to this rule remain regulated ( i.e., subject to reporting requirements). EPA estimates that 33,000 to 34,000 otherwise potentially affected businesses are below the $500,000 sales volume threshold and thus are not subject to this rulemaking, with the result that the $500,000 reporting threshold saves small businesses a total of $138 million to $140 million.

While EPA estimates that between 186 and 1,044 firms will meet the requirements to submit a report, approximately 67,000 firms with sales of $500,000 or more will incur average costs of nearly $5,000 for rule familiarization and compliance determination in order to determine that they do not need to report. Thus, only 0.3% to 1.5% of large firms incurring costs due to the rule are estimated to provide data to EPA. Given that smaller businesses may have fewer resources than large businesses for collecting information and tracking supply chains, an even smaller percentage of the 33,000 to 34,000 firms with revenues under $500,000 would be required to report. Since EPA does not have information to suggest that the smallest entities would have unique information on asbestos COUs on which to report, the $500,000 reporting threshold strikes the appropriate balance between collecting information on asbestos uses and exposures while minimizing, to the extent feasible, the cost of compliance for small manufacturers and processors. Thus, the reporting threshold provides burden relief for companies where reporting is least anticipated—based on EPA's analysis and expertise—while minimizing the risk that the Agency is deprived access to known or reasonably ascertainable information on asbestos.

This change also aligns with the requirement under TSCA Section 8(a)(5)(B) to minimize, to the extent feasible, the cost of compliance for small manufacturers and processors. Additionally, this change aligns with TSCA Section 8(a)(5)(C), which directs EPA to apply reporting obligations to those persons likely to have information relevant to the effective implementation.

Accordingly, based on EPA's expertise, the Agency anticipates that making manufacturers and processors with annual sales greater than or equal to $500,000 (at the ultimate parent company level) subject to the rulemaking ensures that EPA receives reporting on each industry sector impacted by the rule, thereby helping to ensure that the Agency receives information on as many conditions of use as possible involving asbestos. For purposes of this rulemaking, EPA is not aware of instances where entities in a given industry sector with annual sales less than $500,000 (combined with their parent company) are likely to have information regarding asbestos that other entities ( i.e., those with greater than or equal to $500,000 in annual sales) in the same sector would not be able to provide pursuant to the reporting standard. Further, EPA did not receive any comments on the proposed rule that identified any unique aspects of the smallest entities, thus based on EPA's analysis and expertise, and for the reasons identified above, EPA does not believe that such entities are likely to have information on their manufacturing or processing of asbestos.

In response to comments received, EPA added in 40 CFR 704.180(e) an explicit reference to 704.180(d) to clarify that persons exempted in 704.180(d) ( i.e., persons who manufacture or propose to manufacture a non-isolated intermediate, persons who manufacture or processes or propose to manufacture or process asbestos only in small quantities for research and development, persons who are small manufacturers and processors of Libby asbestos, and persons who manufacture or proposes to manufacture asbestos solely as a byproduct) are not required to report.

EPA has changed the appearance of “bulk materials containing asbestos” and its variations to “bulk materials containing asbestos, including as an impurity” and its variations throughout the preamble and regulatory text.

EPA maintains that talc and vermiculite are some examples of the bulk commodities that may contain asbestos as an impurity. However, based on comments received, EPA recognizes that its repeated identification of these specific bulk materials and solely these materials as examples of such bulk commodities could be misconstrued and lead to the belief that asbestos impurities in talc and vermiculite are both unique to and common in these materials. As such, EPA has changed the phrase to read “bulk materials where asbestos can be found as an impurity ( e.g., talc, vermiculite, and other substances)” on first reference only and “bulk materials where asbestos can be found as an impurity” thereafter.

EPA is requiring the reporting of information on specific asbestos types, or if specific information is not known or reasonably ascertainable, reporting on “asbestos” as it is more generally listed on the TSCA Inventory. EPA is also requiring the reporting of information related to asbestos as it is manufactured (including imported) or processed in bulk, as a component of a mixture, in an article or product, including as an impurity. This rule broadly covers asbestos and includes asbestos in the above non-exhaustive list of examples.

EPA is seeking manufacturing (including importing) and processing information associated with the following different fibrous asbestos types, and therefore is requiring that reporting be completed for each of the types, to the extent that the information is known or reasonably ascertainable:

• Asbestos—CASRN 1332-21-4;

• Chrysotile—CASRN 12001-29-5;

• Crocidolite—CASRN 12001-28-4;

• Amosite—CASRN 12172-73-5;

• Anthophyllite—CASRN 77536-67-5;

• Tremolite—CASRN 77536-68-6;

• Actinolite—CASRN 77536-66-4; and

• Libby amphibole asbestos—CASRN not applicable (mainly consisting of tremolite [CASRN 77536-68-6], winchite [CASRN 12425-92-2], and richterite [CASRN 17068-76-7]).

If a specific asbestos type is unknown, a submitter will provide information under the general asbestos form (CASRN 1332-21-4). See Unit II.B. for more information about what is considered asbestos.

Impurity means a chemical substance which is unintentionally present with another chemical substance as per 40 CFR 704.3. Asbestos may occur naturally as an impurity in other products such as talc, vermiculite, and potentially other substances. These products are distributed and used in commerce in the United States. For example, talc, a hydrous magnesium silicate mineral, is used in a wide variety of applications. Talc deposits can contain asbestos as an impurity (Ref. 16). If all other reporting conditions are met ( i.e., the person is not exempted and has annual sales above the reporting threshold), these products are subject to reporting under this rule. EPA is collecting data on asbestos as an impurity because EPA lacks data on the extent to which asbestos as an impurity occurs in products under TSCA jurisdiction that are currently being manufactured (including imported) or processed. In particular, data on asbestos as an impurity could better inform the TSCA Risk Evaluation for Asbestos Part 2 where EPA will determine and then evaluate the relevant conditions of use of asbestos.

This rule requires reporting on articles containing asbestos (including as an impurity). An “article” is defined in 40 CFR 704.3 as “a manufactured item which: (1) is formed to a specific shape or design during manufacture; (2) has end-use function(s) dependent in whole or in part upon its shape or design during end use; and (3) has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article, and that result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles; except that fluids and particles are not considered articles regardless of shape or design.” EPA will collect more data on imported articles containing asbestos; these data could inform the TSCA Risk Evaluation for Asbestos Part 2 where EPA will determine and then evaluate the relevant conditions of use of such articles containing asbestos. Articles included in the TSCA Risk Evaluation for Asbestos Part 1: Chrysotile Asbestos were limited to brake blocks for use in the oil industry, rubber sheets for gaskets used to create a chemical-containment seal in the production of titanium dioxide, certain other types of preformed gaskets, and some vehicle friction products (Ref. 17); EPA is interested in identifying if there are other articles containing asbestos or if there is information about specific types of asbestos in these articles.

Under TSCA section 3(10) (15 U.S.C. 2602(10)), the term “mixture” is defined as “any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction; except that such term does include any combination which occurs, in whole or in part, as a result of a chemical reaction if none of the chemical substances comprising the combination is a new chemical substance and if the combination could have been manufactured (including imported) for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined.” Under this reporting rule, EPA will collect data on asbestos in circumstances where it is a component of a mixture to inform the TSCA Risk Evaluation for Asbestos Part 2. In the Part 2 risk evaluation, EPA will determine the relevant conditions of use of asbestos.

Legislative history affirms that EPA can conduct risk evaluations on a chemical substance when the substance is present as a component of a mixture (See Senate Congressional Record, S3511, June 7, 2016): “In section 6(b) of TSCA, as amended by the Frank R Lautenberg Chemical Safety for the 21st Century Act, EPA is directed to undertake risk evaluations on chemical substances in order to determine whether they pose an unreasonable risk to health or the environment. The definition of ‘conditions of use’ plainly covers all uses of a chemical substance, including its incorporation in a mixture, and thus would clearly enable and require, where relevant, EPA to evaluate the risks of the chemical substance as a component of a mixture.”

Although TSCA section 8(a)(1) provides an exemption for small manufacturers (including importers) and processors, TSCA section 8(a)(3) enables EPA to require small manufacturers (including importers) and processors to report pursuant to TSCA section 8(a) with respect to a chemical substance that is the subject of a rule proposed or promulgated under TSCA sections 4, 5(b)(4), or 6, an order in effect under TSCA sections 4 or 5(e), a consent agreement under TSCA section 4, or relief that has been granted under a civil action under TSCA sections 5 or 7. Six of the asbestos types subject to this rule (chrysotile, crocidolite, amosite, anthophyllite, tremolite, and actinolite) are subject to a TSCA section 6 rule under the Asbestos Ban and Phaseout rule of 1989 (Ref. 1) (40 CFR 763.160 et seq. ) and therefore these types of asbestos may not be eligible for a small manufacturer (including importer) or processor exemption. Although most of the original ban was overturned in 1991 by the Fifth Circuit Court of Appeals, a portion of the section 6 rulemaking remains in effect ( See 40 CFR 763.160 et seq. ). Libby amphibole asbestos, however, is not subject to an applicable proposed or promulgated rule under TSCA sections 4, 5(b)(4), or 6; an order under TSCA sections 4 or 5(e); or a consent agreement under TSCA section 4; and is not the subject of relief that has been granted under a civil action under TSCA section 5 or 7. Therefore, small manufacturers and processors of Libby amphibole asbestos continue to be exempted from reporting.

EPA's experience with the TSCA Risk Evaluation for Asbestos Part 1: Chrysotile Asbestos indicates that small businesses (as defined by the Small Business Administration's size standards) are involved in certain identified conditions of use associated with asbestos. For some conditions of use, EPA identified a single business engaged in each of the activities and, in two cases, the companies were small businesses. In addition, EPA identified multiple conditions of use for which it was unable to identify a single company engaged in the condition of use. Because of the low number of companies found to be involved in specific conditions of use, it is possible that companies associated with other conditions of use that need to be considered in the TSCA Risk Evaluation for Asbestos Part 2 are small businesses.

Because EPA has much less information on the activities of small businesses, the Agency is concerned that certain conditions of use for which the Agency lacks detailed information may be conducted largely or entirely by small businesses. Given EPA's experience and the petitioners' concerns (Refs. 11 and 12), the Agency believes that exempting all small businesses from reporting may exclude most or all of the reporting for some conditions of use which could severely hinder EPA's risk evaluation or risk management activities. As a result, EPA is requiring that small businesses—small manufacturers (including importers) and processors of asbestos and asbestos mixtures (other than Libby amphibole asbestos)—will need to maintain records and, as necessary, report under this action.

Based on comments received, EPA determined that it can alleviate some burden while continuing to address information needs and ensure that the information being sought is reported. EPA, therefore, has decided to set an annual sales threshold, when combined with those of their ultimate parent company (if any) of $500,000, below which manufacturers (including importers) and processors are not subject to the requirements of this rulemaking. The burden reduction includes eliminating rule familiarization, form completion, CBI substantiation, electronic reporting, and recordkeeping requirements for such entities. This change aligns with the requirement under TSCA Section 8(a)(5)(B) to minimize, to the extent feasible, the cost of compliance for small manufacturers (including importers) and processors while ensuring that, pursuant to TSCA Section 8(a)(1), the submission of reports and maintenance of records is necessary for the effective enforcement of TSCA. EPA believes that making manufacturers (including importers) and processors with annual sales equal to or greater than $500,000 (at the ultimate parent company level) subject to the rulemaking ensures that EPA receives reporting on each industry sector impacted by the rule, thereby helping to ensure that the Agency receives information on as many COUs as possible involving asbestos. EPA is not aware of instances where entities in a given industry sector with sales lower than $500,000 are likely to have information that other entities ( i.e., those with equal to or greater than $500,000 in sales) in the same sector would not be able to provide pursuant to the reporting standard. This aligns with the requirement under TSCA Section 8(a)(5)(C) to apply, to the extent feasible, reporting obligations to those persons likely to have information relevant to the effective implementation of Title 1 of TSCA.

EPA believes a threshold based on sales will ensure that representative entities within each industry sector will provide information to EPA regarding their knowledge of asbestos in their products as required ( i.e., when information on the presence or quantity of asbestos in their products is known to or reasonably ascertainable by them). For sectors with varying product lines, EPA expects that entities with sales equal to or greater than $500,000 will generally have more products and thus will fairly represent what is known about the presence of asbestos in such sectors for purposes of providing information to the Agency. This sales-based threshold also serves as a proxy for a volume-based threshold ( i.e., reporting contingent on manufacturing or processing more than a certain quantity during any year of the reporting period) or a quantity- or concentration-based ( i.e., de minimis) threshold, which many commenters supported. EPA recognizes that certain companies with sales less than $500,000 may possess relevant information; however, the Agency anticipates that equivalent information would be known to or reasonably ascertainable by entities with greater sales, given what commenters (EPA-HQ-OPPT-2021-0357-0050, EPA-HQ-OPPT-2021-0357-0051) have stated to be a general lack of information being provided by large manufacturers (including importers) and suppliers on the presence of asbestos in materials provided to smaller downstream entities. Therefore, EPA would receive information on asbestos involving the given sector, which will inform the Agency's activities under TSCA section 6, as well as increase information on asbestos that is generally available. Further, EPA's analysis of industry sectors indicates that this threshold will ensure that representative sites of every particular sector are subject to the rulemaking requirements such that COUs unique to any sector(s) are included.

As noted previously, EPA has determined that it needs certain information from small businesses for the effective implementation of TSCA, therefore is not exempting all small businesses from this rule. The smallest annual sales-based small business size standard is $2.25 million and the largest is $47 million (13 CFR 121.201). Therefore, while the $500,000 annual sales threshold will limit information collected from the smallest subset of these companies, whom EPA does not anticipate would be likely to know or reasonably ascertain that they have manufactured or processed asbestos, it does not broadly exclude all small businesses. EPA anticipates larger firms are more likely to know or reasonably ascertain that they have manufactured or processed asbestos.

EPA will use the small manufacturer (including importer) definition already established at 40 CFR 704.3. Thus, any entity manufacturing (including importing) Libby amphibole asbestos is considered a small manufacturer and exempt from reporting if it meets either of these two standards (as adjusted by an inflation index):

• Total sales during the most recent year of the reporting period, combined with those of the parent company, domestic or foreign (if any), are less than $120 million and the annual production and importation volume of that chemical substance ( i.e., asbestos) does not exceed 100,000 pounds at any individual plant site. If the annual production and importation volume of the chemical substance ( i.e., asbestos) at any individual site owned or controlled by the submitter is greater than 100,000 pounds, the submitter is required to report for that particular site unless it qualifies as small under the following standard.

• Total sales during the most recent year of the reporting period, combined with those of the parent company, domestic or foreign (if any), are less than $12 million regardless of the quantity of asbestos produced or imported.

The definition for small manufacturer (including importer) in the general TSCA section 8 regulations, as written in the Small manufacturer and Small government definitions (40 CFR 704.3), applies to domestic manufacturers and importers, but does not cover processors. Therefore, EPA is using a definition for small processors functionally identical to that established in 40 CFR 704.20— Chemical substances manufactured or processed at the nanoscale (Ref. 18) which was prescribed after consultation with SBA. Likewise, in proposing this modified definition for this one-time reporting rule, EPA provided notice and comment on the criteria for small processors and consulted with the SBA in accordance with TSCA section 8(a)(3)(B). Comments received and responses thereof are provided in Response to Public Comments document (Ref. 15).

EPA is finalizing the slightly modified version of the nanoscale definition for small processors because it is most similar to the general small manufacturing (including importing) definition already promulgated. The definition for this rulemaking states: “Small processor means any processor whose total annual sales, when combined with those of its parent company (if any), are less than $12 million.” Note that in the nanoscale rule, the total annual sales threshold is $11 million. EPA increased the threshold for this asbestos rulemaking to $12 million to align with the non- volume portion of the TSCA small manufacturer definition in 40 CFR 704.3, which was updated in 2020. The small manufacturer definition has a second standard that exempts companies on a chemical-by-chemical volume basis ( i.e., 100,000-pound threshold when company sales are less than $120 million), thus exempting small manufacturers for some chemicals but not for others. The second standard is not appropriate to include in the small processor definition because the amount of asbestos in products may vary drastically. It is also not appropriate because EPA is not basing reporting requirements on volumes for this rule. Thus, the volume of asbestos is less applicable as a measure than sales.

This rule uses the reporting standard used for certain other TSCA section 8(a) reporting requirements, including CDR. This standard requires that manufacturers (including importers) and processors report information to the extent that the information is known to or reasonably ascertainable by the manufacturer (including importer) or processor (see TSCA section 8(a)(2)). “Known to or reasonably ascertainable by” includes “all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know” per 40 CFR 704.3. This reporting standard requires reporting entities to evaluate their current level of knowledge of their manufactured products (including imports) or processed products, as well as to evaluate whether there is additional information that a reasonable person, similarly situated, would be expected to know, possess, or control. This standard carries with it an exercise of due diligence, and the information-gathering activities that may be necessary for manufacturers (including importers) and processors to achieve this reporting standard may vary from case to case.

This standard requires that submitters conduct a reasonable inquiry within the full scope of their organization (not just the information known to managerial or supervisory employees). This standard may also entail inquiries outside the organization to fill gaps in the submitter's knowledge. Such activities may, though not necessarily, include phone calls or email inquiries to upstream suppliers or downstream users or employees or other agents of the manufacturer (including importer) or processor, including persons involved in the research and development, import or production, or marketing of asbestos. Examples of types of information that are considered to be in a manufacturer's (including importer's) or processor's possession or control, or that a reasonable person similarly situated might be expected to possess, control, or know include: files maintained by the manufacturer (including importer) or processor such as marketing studies, sales reports, or customer surveys; information contained in standard references showing use information or concentrations of chemical substances in mixtures, such as a Safety Data Sheet (SDS) or a supplier notification; and information from CAS or from Dun & Bradstreet (D-U-N-S). This information may also include knowledge gained through discussions, conferences, and technical publications.

EPA has provided CDR reporting guidance materials on this reporting standard, including hypothetical examples of applying the “known to or reasonably ascertainable by” reporting standard in the context of collecting processing and use data for CDR, which would be instructive for reporting under this rule as well (Ref. 9). Therefore, EPA anticipates some submitters under this rule will be familiar with this reporting standard, and resources are available to support those submitters who may not be familiar with the standard. In response to public comments, EPA will provide such guidance and a compliance guide.

EPA acknowledges that it is possible that a manufacturer (including importer) or processor, particularly an importer of articles containing asbestos (including as an impurity), may not have knowledge that they have imported asbestos and thus not report under this rule, even after they have conducted their due diligence under this reporting standard as described previously. Such an importer should document its activities to support any claims it might need to make related to due diligence.

In the event that a manufacturer (including importer) or processor does not have actual data ( e.g., measurements or monitoring data) to report to EPA, the manufacturer (including importer) or processor may make “reasonable estimates” of such information. “Reasonable estimates” may rely, for example, on approaches such as mass balance calculations, emissions factors, or best engineering judgment. See section A.2.2 of the Response to Comments document for further discussion of the reporting standard.

This rulemaking results in a one-time reporting obligation. EPA requires reporting for persons who have manufactured (including imported) or processed asbestos, including as an impurity in bulk materials or products, at any time during the four complete calendar years prior to the effective date of the final rule. The four calendar years are 2019 to 2022. These entities will report to EPA during a three-month submission period, which will begin six months following the effective date of the final rule. Therefore, manufacturers (including importers) and processors have up to nine months following the effective date of this final rule to collect and submit all required information to EPA.

EPA believes that providing six months between the effective date of the rule and the start of the submission period allows sufficient time for both the Agency to finalize the reporting tool and for submitters to familiarize themselves with the rule and compile the required information. Since this TSCA section 8(a)(1) reporting rule results in the collection of similar information to that collected under CDR, EPA anticipates some submitters will be familiar with the types of information requested and how to report. EPA received several comments on the proposed rule requesting that the reporting deadline be extended by as much as 18 months. EPA evaluated these comments and determined that three months is adequate time for submissions, in addition to the six-month period between the effective date and the start of the submission period. This period ( i.e., reporting due by nine months after the effective date of the rule) deadline is commensurate with the estimated time needed to obtain and report the data that this rulemaking requires. Further, ensuring prompt reporting of these data is necessary to inform EPA's TSCA risk evaluation and risk management activities involving asbestos.

EPA is establishing different reporting requirements based on a two-part knowledge-based reporting approach in order to obtain as complete a picture as possible of the manufacturing (including importing), processing, and use of asbestos. Because asbestos can be included in small quantities in some products, a threshold concentration for reporting might eliminate much of the information that may be useful to support EPA's TSCA risk evaluation and risk management efforts. Therefore, EPA is requiring reporting whenever the presence of asbestos is known or reasonably ascertainable.

However, EPA is also aware that there may be circumstances under which a manufacturer (including importer), or processor is unable to provide a quantity of the asbestos in their products because the percentage of asbestos in their products is not known to or reasonably ascertainable by them. For those situations, EPA is providing a short form (Form A) for attestation purposes. For other situations, submitters who can determine or estimate the quantity will provide more detailed information in the full form (Form B). EPA anticipates that most submitters would know or be able to estimate the quantity of the asbestos and would complete the full form. Because the reporting this rulemaking requires will be electronic, both Form A and Form B are integrated into a single reporting tool application; preparers will be prompted to provide additional Form B data when they indicate they know or are able to provide a reasonable estimate of the quantity of asbestos.

Submitters who are aware of asbestos in their product, but who are unable to determine or estimate the quantity manufactured (including imported) or processed, will use Form A to provide a subset of the information required on Form B. This subset of information consists of information related to manufacturing (including importing) or processing asbestos, including as an impurity, in an article, or as a component of a mixture, and information about the employees involved with such activities.

One of the goals of this rule is to ensure EPA has a complete picture of known or reasonably ascertainable information regarding of asbestos manufacturing (including importing) and processing in the United States. Therefore, EPA is requiring a reporting approach that will ensure that even circumstances where asbestos exists in unknown quantities are captured. Some entities manufacturing (including importing) or processing asbestos as a component of a mixture or articles containing asbestos (including as an impurity) ( e.g., the importers of articles), may be aware of asbestos in their products but unable to determine or estimate the quantity of the asbestos for reporting purposes. Therefore, EPA is including the short form (Form A) for such entities that are aware of presence of asbestos in their products, but unable to determine (or estimate) the quantity manufactured (including imported) or processed of asbestos to report.

For a more detailed discussion of the data elements, please see Unit IV.F. EPA anticipates that Form A will be the less common option of the two reporting forms.

EPA requires that if a quantity of asbestos in a product is known to or reasonably ascertainable by the submitter, then the submitter must provide the more detailed reporting information required by Form B. For example, if submitters are able to determine that their quantity of asbestos is close to a given quantity, they are required to report that quantity using Form B.

Form B requires specific quantity information per asbestos type, more detailed processing information, and employee information (including employee exposure information). For a more detailed discussion on specifics included in Form B, see Unit IV.F.

EPA is requiring certain information to be reported in either Form A or Form B. Unit IV.E. describes how to choose which form to use for reporting. This unit provides a more in-depth overview of the information to be reported. Each form has sections about respondent identification, mined ( i.e., extracted) or milled ( e.g., crushed, grinded) bulk asbestos and bulk material containing asbestos, imported bulk asbestos, primary processor production, secondary processor production, importation of mixtures, and importation of articles. Form A is a subset of Form B. If a data element is included in Form B only, it is indicated by “(Form B only)” following the name of the data element.

EPA is requiring that both Form A and B include information associated with identifying the respondent company and site and information about contacts at the company or site who can respond to any clarifying or other follow up questions from EPA. Specifically, EPA is requiring that submitters report the following information (40 CFR 704.180(e)(3)):

• U.S. Parent Company Information;

• Authorized Official Contact Information;

• Technical Contact Information; and

• Site Information (including NAICs codes and total number of employees at site).

In addition, submitters will identify the activity for which they are reporting, selecting from the list provided in 40 CFR 704.180(e)(4)(i). If more than one activity applies, the submitter will indicate all that apply. Each activity and the associated data elements are described in the remainder of this Unit.

An asbestos mine or mill is an entity that either mines or mills asbestos-containing ore. Mined ( i.e., extracted) asbestos-containing ore is further milled to produce bulk asbestos. Milling involves the separation of the fibers from the ore, grading and sorting the fibers, or fiberizing crude asbestos ore. An importer of bulk asbestos imports bulk asbestos into the customs territory of the United States. EPA anticipates that companies who are mining, milling, or importing bulk asbestos will report using Form B, because the volume of asbestos is likely known to or reasonably ascertainable by them.

For companies that are mining, milling, or importing bulk materials where asbestos can be found as an impurity, EPA anticipates that they would report using either Form A or Form B, based upon their knowledge of the quantity of asbestos in their bulk material. EPA does not anticipate that asbestos is produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance or mixture (see 40 CFR 704.3). Thus, EPA has not lifted the general reporting exemption for persons who manufacture, import, or proposes to manufacture or import asbestos solely as a byproduct (see 40 CFR 704.5(b)).

Specifically, EPA is requiring that sites involved in mining, milling, or importing asbestos or bulk materials containing asbestos, including as an impurity, report certain information associated with those activities, as listed in 40 CFR 704.180(e)(4)(ii) and (iii), and (e)(5). All submitters will report the applicable asbestos type associated with the mining, milling, or importing activity. Submitters who import asbestos or bulk materials containing asbestos, including as an impurity into the United States, but do not receive it at their physical location ( i.e., the material is instead received directly by a customer) can indicate such material was never physically present at the site of the importer, if appropriate.

a. Bulk asbestos. In addition, EPA is requiring that sites involved in mining, milling, or importing bulk asbestos, for each asbestos type and for each year, report the quantity of asbestos and the disposition of asbestos. Table 3 in 40 CFR 704.180(e)(4)(ii)(B) provides a list of dispositions from which to select, including: used on site, sent to another U.S. site, exported, or disposed of. EPA is requiring that a site selecting “Disposed of within the U.S.” provides additional explanation to indicate the quantity and type of disposal ( e.g., disposed in a landfill).

b. Bulk materials containing asbestos, including as an impurity. EPA is requiring that sites involved in mining, milling, or importing bulk materials containing asbestos, including as an impurity, also report the type of bulk material that is manufactured (including imported) or processed, and for each type of bulk material and year, report:

• The quantity of bulk material quantity by weight (Form B only);

• The percentage of asbestos in the bulk material (Form B only);

• The most specific types of asbestos. If a specific asbestos type is unknown, a submitter will provide information under the general asbestos form (CASRN 1332-21-4) (Form B only);

• Information describing how the amount of asbestos in the bulk material is known (Form B only); and

• The disposition of the bulk material as described in Unit IV.F.2.a.

A primary processor starts with bulk asbestos or bulk materials containing asbestos, including as an impurity and makes a mixture that contains asbestos as a component. A primary processor may simply mix or repackage different types or sizes of fibers and then sell that product. Mixtures that contain asbestos are products to which asbestos has been intentionally added and which can be used or processed further and incorporated into other products. For example, asbestos cement, asbestos paper, and asbestos-reinforced plastics are instances where asbestos is contained in a mixture. Primary processors are defined in the 40 CFR 704.180(a), a definition adapted from the definition of primary processor in the 1982 Asbestos Reporting Requirements Rule (see Unit II.C.1.).

EPA anticipates that primary processors starting with bulk asbestos are more likely to report using Form B while those starting with bulk materials containing asbestos, including as an impurity, may report using either Form A or Form B.

EPA is requiring that primary processors report, for each year, the total quantity of asbestos processed (Form B only) and the end product type (selected from Table 4 in 40 CFR 704.180(e)(4)(iv)(B)). For each product type, report by year:

• The most specific types of asbestos (Form B only);

• The total annual production quantity of end product, using the unit of measure as listed in Table 4 in 40 CFR 704.180(e)(4)(iv)(B);

• The percentage of asbestos in the end product (Form B only);

• If the asbestos content is an impurity, how the presence, amount, and type of asbestos is known ( i.e., do you have test results (provide the results), how often is testing conducted, other methods for identifying the asbestos content); and

• The disposition of the end product (Form B only) as described in Unit IV.F.2.a.

Secondary processors are those who start with asbestos when it is a component of a mixture and incorporate the mixture into their own products. For example, persons who fabricate asbestos cement sheet by cutting the sheet to make an electrical switch board, or persons who make garments by cutting an asbestos-containing textile, are secondary processors. Secondary processors are defined in 40 CFR 704.180(a), a definition adapted from the definition of primary processor in the 1982 Asbestos Reporting Requirements Rule (see Unit II.C.1.).

EPA anticipates that secondary processors may report using either Form A or Form B. EPA is requiring that secondary processors report, for each year, the total quantity of asbestos processed (Form B only) and the end product type (selected from Table 4 in 40 CFR 704.180(e)(4)(iv)(B)). For each product type, report by year:

• The most specific types of asbestos and the quantity of asbestos (Form B only);

• The total annual production quantity of end product, using the unit of measure as listed in Table 4 in 40 CFR704.180(e)(4)(iv)(B);

• The percentage of asbestos in the end product (Form B only);

• If the asbestos content is an impurity, how the presence, amount, and type of asbestos is known ( i.e., do you have test results (provide the results), how often is testing conducted, other methods for identifying the asbestos content); and

• The disposition of the end product (Form B only) as described in Unit IV.F.2.a.

An importer of asbestos contained in a mixture or article that contain asbestos, including as an impurity, imports these substances into the customs territory of the United States.

EPA anticipates that an importer of articles and/or products may report using either Form A or Form B. EPA is requiring that importers report, for each year, the total quantity of asbestos processed (Form B only) and the imported product type (selected from Table 4 in 40 CFR 704.180(e)(4)(iv)(B)). For each product type, report by year:

• Whether the imported product including asbestos is contained in a mixture or a part of an article;

• The most specific types of asbestos and the quantity of each asbestos type (Form B only);

• The total annual import quantity of the imported product, using the unit of measure as listed in Table 4 of 40 CFR 704.180(e)(4)(iv)(B);

• The percentage of asbestos in the imported product (Form B only);

• Information about how the presence, amount, and type of asbestos is known ( i.e., do you have test results (provide the results), how often is testing conducted, other methods for identifying the asbestos content); and

• The disposition of the imported product (Form B only) as described in Unit IV.F.2.a.

Submitters who import asbestos as a component of a mixture or an article that contains asbestos, including as an impurity can indicate such material was never physically present at the site of the importer, if appropriate.

For each activity reported, EPA is requiring that submitters also report certain information about the number of employees involved with the activity. Specifically, EPA is requiring that submitters report the number of employees associated with the activity, whether personal protective equipment was used and, if yes, the type of equipment used, and any workplace exposure measurement assessments such as monitoring data. When supplying the measurement assessment data, also include information about how the assessment was conducted and other explanations to help EPA better understand and use the data.

When evaluating which data elements to include in this final rule, EPA also considered potentially requiring reporting on additional information related to current employee exposures, wastewater treatment, disposal information, and customer sites. EPA specifically sought comment on if additional data elements should be required, and the majority of commenters were not supportive of additional data element. EPA chose not to include these additional data elements in this final rule in the interest of maintaining a manageable level of burden for reporting entities. EPA also believes that the data elements described in Unit IV.F. will provide sufficient information for use by EPA and other Federal agencies in potential actions involving asbestos, including EPA's TSCA risk evaluation and risk management activities.

EPA considered collecting information related to asbestos or asbestos-containing discharges, including releases, wastes, and disposal data. These data included a description of any discharges, such as to water or to off-site public treatment facilities, and descriptions of solids disposal, such as to land-based facilities. Wastewater related information included volumes of wastewater, amount of asbestos in the wastewater, on-site treatment methods (if any), National Pollutant Discharge Elimination System (NPDES) permit numbers and copies of reports, transport to off-site treatment, and removed solids management. General waste and disposal information included the identity of the end product being disposed, the form of the waste, the quantity of asbestos in the waste, the type of land disposal facility ( e.g., impoundment, waste pile, landfill, injection well), and whether the disposal is on- or off-site. Note, however, that EPA is requiring that a site reporting “Disposed of within the U.S.” in response to Table 3 must provide additional explanation to indicate the quantity, address of the disposal facility, and type of disposal ( e.g., disposed in a landfill). EPA believes this level of reporting on waste disposal data is sufficient for purposes of this data collection. Due to the anticipated burden for reporters in contrast to the usefulness of the data that the Agency could collect, EPA is not including reporting on additional data elements related to wastewater discharge and waste disposal in this final rule beyond the disposal explanation that will be included in response to reporting “Disposed of within the U.S.” in response to Table 3.

EPA considered collecting information related to air emissions at facilities that manufacture (including import) or process asbestos or asbestos-containing mixtures and products. The information included sources of emissions, methods of air pollution control, descriptions of control devices, and pollution control equipment operation and testing frequency and methods. Due to the anticipated burden for reporters in contrast to the usefulness of the data that the Agency could collect, EPA is not including reporting on these additional data elements in this final rule.

EPA also considered requiring additional information about the number of customers respondents have. For the reasons described previously, EPA is not including reporting on these additional data elements in this final rule; however, EPA is requiring manufacturers (including importers) and processors of asbestos that are selling a product that contains asbestos to report the number of customer sites they have.

EPA is requiring electronic reporting similar to the requirements established in 2013 for submitting other information under TSCA (see 40 CFR 704.20(e)). EPA is requiring that submitters use EPA's CDX (Central Data Exchange), the Agency's electronic reporting portal, for all reporting under this rule. In 2013, EPA finalized a rule to require electronic reporting of certain information submitted to the Agency under TSCA sections 4, 5, 8(a), and 8(d) (78 FR 72818, December 4, 2013 (FRL-9394-6)). The final rule followed two previous rules requiring similar electronic reporting of information submitted to EPA for TSCA CDR and for premanufacture notices (PMNs). By requiring similar electronic reporting under this rule, EPA expects that electronic reporting would save time, improve data quality, and increase efficiencies for both the submitters and the Agency.

EPA developed the Chemical Information Submission System (CISS) for use in submitting data electronically to the Agency for TSCA sections 4, 5, 6, 8(a), 8(b), 8(d), 8(e), and Title VI. CISS, a web-based reporting tool housed within the CDX environment, provides submitters with user-friendly applications to build and submit data packages to EPA within a secure, encrypted environment. CISS applications provide for the capture of both fielded data as well as the attachment of additional information using a wide variety of file types. Submitted information is rendered into PDF and XML formats, which are provided to submitters in the form of a Copy of Record.

EPA is requiring that submitters follow the same submission procedures used for other TSCA submissions ( i.e., to register with EPA's CDX and use CISS to prepare a data file for submission). Registration enables CDX to authenticate user identity. To submit electronically to EPA via CDX, individuals must first register with CDX at http://cdx.epa.gov/. To register in CDX, the CDX registrant (also referred to as “Electronic Signature Holder” or “Public/Private Key Holder”) agrees to the Terms and Conditions, provides information about the submitter and organization, selects a username and password, and follows the procedures outlined in the guidance document for CDX available at https://cdx.epa.gov/FAQ#CSPP.

Within CDX, CISS is available under the “Submission for Chemical Safety and Pesticide Program (CSPP)” CDX flow. Users who have previously submitted under TSCA through CDX, including submitting information under TSCA sections 4 and 5, CDR, or reporting under the TSCA Inventory Notification (Active-Inactive) Requirements rule (82 FR 37520, Aug. 11, 2017 (FRL-9964-22)), will already have the CSPP flow linked to their account. Users reporting to EPA using other CDX housed applications, including the Toxics Release Inventory TRI-MEweb, would be able to add the CSPP flow to their existing CDX accounts.

All submitters are required to use CISS to prepare their submissions. CISS guides users through a “hands-on” process of creating an electronic submission. Once a user completes the relevant data fields and attaches appropriate PDF files, or other file types, such as XML files, the web-based tool validates the submission by performing a basic error check and makes sure all the required fields and attachments are provided and complete. Further instructions for uploading PDF attachments or other file types, such as XML, and completing metadata information would be available through CISS reporting guidance.

CISS also allows the user to choose to “Preview,” “Save,” or “Submit” the data package. Once the submission process is initiated, the user is asked to certify the information and provide requested information to complete the submission process. The data package is then sent, in an encrypted state, to the Agency. The user can login to the application and check the submission status of their data package. Upon successful receipt of the submission by EPA, the submission status of the submissions will be flagged as “Completed” and a confirmation email will be sent to the submitter's CDX inbox. The CDX inbox is used to notify the users when submissions are received by EPA or to notify users when a submission-specific communication has been received and how to locate and access the communication. Information on accessing the CDX user inbox is provided in the guidance document for CDX at https://cdx.epa.gov/FAQ#CSPP. To access CISS log into CDX using the link: https://cdx.epa.gov and click on the appropriate user role associated with the CSPP data flow. For further instructions, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/electronic-reporting-requirements-certain-information. Procedures for reporting under this rule are similar.

EPA believes that electronic reporting reduces the reporting burden for submitters by reducing the cost and time required to review, edit, and transmit data to the Agency. It also allows submitters to share a draft submission within their organization, and more easily save a copy for their records or future use. Additionally, EPA believes that some of the anticipated submitters under this rule have experience with reporting electronically to EPA through CDX. The resource and time requirements to review and process data by the Agency will also be reduced and document storage and retrieval will require fewer resources. EPA expects to benefit from receiving electronic submissions and communicating electronically with submitters.

In a separate rulemaking, EPA proposed new provisions concerning the assertion and treatment of CBI claims for information reported to or otherwise obtained by EPA under TSCA (87 FR 29078, May 12, 2022 (FRL-8223-01-OCSPP)). Unless otherwise stated in specific TSCA regulations, EPA intends the proposed provisions to govern how CBI claims made for information submitted under TSCA, including information submitted under this part, will be asserted, reviewed, and maintained.

In this rulemaking, EPA is requiring in 40 CFR 704.180(h) that a person submitting a reporting form under this action may claim some information in the form as confidential at the time of submission, consistent with TSCA section 14. EPA is also providing that certain data elements cannot be claimed as confidential:

• Site NAICS code in 40 CFR 704.180(e)(3)(v), because it represents a general description associated with the manufacture (including import) or processing of a chemical substance.

• Chemical and bulk material identities (as identified in 40 CFR 704.180(h)(1)(ii)(B)), because the chemical identities are listed in the asbestos definition in 40 CFR 704.180(a) or are general identities of bulk materials that are already publicly known.

• Responses that are blank or “not known or reasonably ascertainable” (as identified in 40 CFR 704.180(h)(1)(ii)(C)) because there is no data to claim as confidential.

• Health and safety study data (as identified in 40 CFR 704.180(h)(1)(ii)(D)), because, under TSCA section 14(b)(2), such information is not protected from disclosure. Note, however, that CBI claims may be asserted to the extent that disclosure of data from studies would reveal certain information as provided in 40 CFR 704.180(h)(1)(ii)(D)(1)-(3). The electronic reporting tool described in 40 CFR 704.180(i) enables the submitter of a health and safety study containing CBI claims to attach a public copy of the study, as described in 40 CFR 704.180(h)(2)(vi).

TSCA section 14 also requires that the submitter attest to a statement concerning the confidential status of the information, that they have a reasonable basis to conclude that release of the information would likely result in substantial harm to the competitive position of their business and that the information is not readily discoverable through reverse engineering. The submitter must certify that this statement and any substantiation provided are true and correct. This certification statement will be incorporated into the electronic reporting tool identified in 40 CFR 704.180(i).

TSCA section 14(c)(3) further requires that substantiation be provided at the time a confidentiality claim is asserted. However, TSCA section 14(c)(2) exempts certain information from that substantiation requirement ( e.g., specific production volume). Under this rule, CBI claims for specific production or import volumes of the manufacturer need not be substantiated, as identified in 40 CFR 704.180(h)(2)(iv). For all other information submitted under this rule, submitters are required to substantiate their confidentiality claims at the time of submission. Substantiation questions are listed in 40 CFR 704.180(h)(2)(iii) and will be incorporated into the electronic reporting tool identified in 40 CFR 704.180(i). Responses to the substantiation questions that are not specific to the data element for which a claim of confidentiality is being substantiated may be inadequate to justify confidential protection.

Any information which is claimed as confidential will be disclosed by EPA only in accordance with the procedures and requirements of TSCA section 14 and 40 CFR part 2, or any TSCA-specific CBI provisions that may in the future replace or supplement portions of 40 CFR part 2. TSCA section 14(b)(2) limits confidentiality protections for health and safety studies and information from health and safety studies regarding chemical substances that have been offered for commercial distribution, except to the extent such studies or information reveals “information that discloses processes used in the manufacturing (including importing) or processing of a chemical substance or mixture or, in the case of a mixture, the portion of the mixture comprised by any of the chemical substances in the mixture.” The workplace exposure measurement data listed in 40 CFR 704.180(e)(5)(iii) are from studies pertaining to human exposure in the workplace and therefore are considered health and safety study data. Submitters asserting a confidentiality claim for such information as provided in 40 CFR 704.180(h)(1)(ii)(D)(1)-(3) in health and safety studies will be required to submit a sanitized copy of the study, removing only that information which is claimed as confidential. See 40 CFR 704.180(h)(1)(ii)(D) for additional information regarding health and safety studies and 40 CFR 704.180(h)(2)(vi)) regarding public copies.

EPA is requiring that each person who reports under this part must maintain records that document information reported under this part and, in accordance with TSCA, permit access to and the copying of such records by EPA officials. Consistent with the CDR rule, EPA is requiring a five-year recordkeeping period, beginning on the last date of the submission period. The five-year retention requirement generally corresponds with the statute of limitations for TSCA violations. Information in this one-time data collection will be used by EPA for risk evaluation and risk management activities, and the companies must maintain the records for five years in the event that EPA has follow-up questions as the associated Agency activities are completed. Further, EPA believes the burden of retaining these records, which are likely electronic, is minimal.

As demonstrated by the different reporting and recordkeeping requirements in this rulemaking and the structure of this rule in addressing them independently, EPA generally intends the rule's provisions to be severable from each other. As such, to the extent that any portion of this rule is declared invalid, EPA intends those provisions to be severable and the remaining provisions continue to be valid.

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

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

This action is a “significant regulatory action”, as defined under section 3(f)(1) of Executive Order 12866, as amended by Executive Order 14094. Accordingly, EPA, submitted this action to the Office of Management and Budget (OMB) for Executive Order 12866 review. Documentation of any changes made in response to the Executive Order 12866 review is available in the docket. EPA prepared an economic analysis of the potential costs and benefits associated with this action (Ref. 2), which is summarized in Unit I.E. and available in the docket.

The information collection requirements in this rule will be submitted to OMB for approval under the PRA, 44 U.S.C. 3501 et seq. The Information Collection Request (ICR) document that EPA prepared has been assigned EPA ICR No. 2711.02 (Ref. 19) and the OMB Control No. 2070-0222. You can find a copy of the ICR document in the docket for this action, and it is briefly summarized here. The information collection requirements are not enforceable until OMB approves them.

The information collection activities in the rule include a one-time reporting by companies that manufacture (including import) or process asbestos of certain information to EPA and the requirement to maintain corresponding records.

Reported information would be used by EPA and other Federal agencies in considering potential actions on asbestos, including EPA's TSCA risk evaluation and risk management activities. Reporting requirements may provide EPA with baseline information needed to assess whether certain “conditions of use” of asbestos pose an unreasonable risk to human health or the environment under TSCA section 6(b). EPA must consider reasonably available information as part of the risk evaluation process under TSCA section 6(b), and as part of any subsequent risk management rulemaking efforts under TSCA section 6(a). Understanding the health risks of asbestos and protecting the public and potentially exposed or susceptible subpopulations from these risks is a priority for EPA. Data collected by this rule could help to fill data gaps that EPA may have in exposure for asbestos that could better inform Part 2 of the asbestos risk evaluation. Following risk evaluation, TSCA mandates that EPA take action if the Agency determines that asbestos presents unreasonable risk to health or the environment. EPA needs to ensure that sufficient information is reasonably available on the uses and trends of asbestos activities to conduct the asbestos Part 2 Risk Evaluation, and if the Agency determines asbestos presents unreasonable risk based on that risk evaluation, then develop a risk management rule that would address any unreasonable risk.

TSCA section 14 imposes requirements for the assertion, substantiation, and review of information that is claimed as confidential under TSCA. Some information submitted at the time of the reporting under this rule may be claimed as confidential.

Respondents/affected entities: Asbestos manufacturers (including importers) and processors. See also Unit I.A.

Respondent obligation to respond: Mandatory. TSCA section 8(a) and 40 CFR 704.180.

Frequency of response: One time.

Total estimated number of respondents: 375.

Total estimated number of responses: 375.

Total estimated burden: 1.5 million hours (per year average). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $107.7 million (per year average), which includes no annualized capital or operation and maintenance costs.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves this ICR, the Agency will announce that approval in the Federal Register and publish a technical amendment to 40 CFR part 9 to display the OMB control number for the approved information collection activities contained in this final rule.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. The small entities subject to the requirements of this action are persons who have manufactured (including imported), or processed asbestos, including asbestos as a component of a mixture, in an article, and as an impurity in any of the four full calendar years prior to the effective date of this rule. The Agency has determined that approximately 66,000 small firms may be affected by the rule. In the proposed rule, because EPA did not estimate the number of manufacturers or processors of impurities, EPA estimated that 15 small businesses would be affected. The total cost to small businesses is $279 million to $283 million, essentially all of which is an increase compared to the estimates for the proposed rule (since EPA did not estimate the number of manufacturers or processors of impurities at the proposed rule stage). There are 32,000 to 33,000 small businesses that are not subject to this rule because their revenues are less than $500,000. (The range is based on the potential number of firms that otherwise would have reported for importing aftermarket automotive brakes in the absence of the $500,000 threshold.) The $500,000 reporting threshold saves small businesses a total of $138 million to $140 million.

Costs to small businesses range from $4,430 per firm (for firms reporting on products that intentionally contain asbestos) to $11,273 per firm (for firms reporting on asbestos present as an impurity). Of small firms affected by the rule, 99.93 percent are expected to have cost impacts of less than 1% of annual revenues, 0.07 percent are expected to have impacts between 1-3 percent, and none are expected to have impacts of more than 3 percent of annual revenues. Details of this analysis are presented in the Economic Analysis (Ref. 2).

One small oilfield brake block importer, 2 small gasket manufacturers, and 9 to 849 small firms in the aftermarket automotive brake industry are predicted to report. The average cost for these small firms is $4,430, as shown in Table 7-14 of the Economic Analysis (Ref. 2). The cost impact to these firms is less than 1% of revenues, which does not represent a significant impact on these small firms.

As shown in Table 7-14 of the Economic Analysis (Ref. 2), 166 small firms are predicted to report for asbestos present as an impurity, at an average cost of $11,273. Of these firms, 118 have a cost impact of less than 1% of revenues and 48 have a cost impact between 1% and 3% of revenues. This does not represent a significant impact on these small firms.

Table 7-14 of the Economic Analysis (Ref. 2) also indicates that there are 65,335 small firms estimated to conduct compliance determination for asbestos as an impurity but not submit a report, incurring an average cost of $4,703. All of these firms have cost impacts of less than 1% of revenues, and thus do not incur significant impacts.

This action contains a federal mandate under UMRA, 2 U.S.C. 1531-1538, that may result in expenditures of $100 million or more for state, local and tribal governments, in the aggregate, or for the private sector in any one year. Accordingly, the EPA has prepared a written statement (Ref. 20) as required under UMRA section 202 that is included in the docket for this action and is briefly summarized here.

1. Authorizing Legislation. This rule is issued under the authority of TSCA section 8(a)(1), 15 U.S.C. 2607 (a)(1).

2. Benefit-Cost Analysis. EPA has prepared an economic analysis to evaluate, among other things, the benefits and costs of this rule (Ref. 2). The rule is calculated to result in a total one-time cost to the private sector of $319 million to $323 million. When adjusted for inflation, the $100 million UMRA threshold is equivalent to approximately $170 million. Thus, the cost of the rule to the private sector in the aggregate exceeds the inflation-adjusted UMRA threshold.

Because this is an information-collecting rule, EPA is not able to quantitatively measure the associated benefits. However, the rule may supply information on asbestos to which Federal agencies (and the public) do not currently have access. By enhancing the data supplied to risk-screening and risk-management programs, EPA expects to more effectively and expeditiously evaluate and manage any potential unreasonable risk posed by asbestos. The more EPA can base its decisions on actual data rather than on assumptions, the better EPA is able to tailor its risk management decisions to the level of actual risk, whether higher or lower than it would be if based on assumptions alone. Ultimately, enhancing the risk evaluation process will have positive consequences for human health and the environment and may enable a more efficient allocation of EPA's and society's resources.

3. Impacts on State, local, and Tribal governments. This rule does not contain a significant Federal intergovernmental mandate because it neither imposes enforceable duties on State, local, or Tribal governments nor reduces an authorized amount of Federal financial assistance provided to State, local, or tribal governments. This rule contains no regulatory requirements that might significantly or uniquely affect small governments. The rule would require reporting from certain persons who manufactured (including imported) or processed asbestos and asbestos-containing articles (including as an impurity and as a component of a mixture). Governments do not typically engage in these activities, so State, local, and tribal government entities are not expected to be subject to the rule's requirements. This action is not subject to the requirements of UMRA section 203 because it contains no regulatory requirements that might significantly or uniquely affect small governments.

This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999) because it will not have substantial direct effects 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. Thus, Executive Order 13175 does not apply to this action.

This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000) because it will not have substantial direct effects on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. It does not have substantial direct effects on tribal government because EPA does not anticipate that asbestos was manufactured (including imported) or processed by tribes so this rulemaking is not expected to impose substantial direct compliance costs on tribal governments. Thus, Executive Order 13175 does not apply to this action.

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of Executive Order 13045. This action is not subject to Executive Order 13045, because it does not concern an environmental health or safety risk. Since this action does not concern human health, EPA's Policy on Children's Health also does not apply.

Although this action does not concern an environmental health or safety risk, this one-time data collection will provide information that will be used to support the ongoing EPA risk evaluation of asbestos under TSCA, among other activities. The purpose of a TSCA risk evaluation is to determine whether a chemical substance presents an unreasonable risk to health or the environment, under the conditions of use, including an unreasonable risk to a relevant potentially exposed or susceptible subpopulation. As required by TSCA section (6)(b), EPA established a process to conduct these risk evaluations, see the final rule entitled “Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act” (82 FR 33726, July 20, 2017 (FRL-9964-38)) (Risk Evaluation Rule). Pursuant to TSCA and the Risk Evaluation Rule, as part of the risk evaluation process, EPA must (1) evaluate both hazard and exposure, (2) exclude consideration of costs or other non-risk factors, (3) use scientific information and approaches in a manner that is consistent with the requirements in TSCA for the best available science, and (4) ensure decisions are based on the weight-of-scientific-evidence. EPA also believes that the information obtained as a result of this one-time data collection could also be used by the public, government agencies and others to identify potential problems, set priorities, and take appropriate steps to reduce any potential human health or environmental risks identified in the TSCA risk evaluation.

This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. Further, we have concluded that this action is not likely to have any adverse effect on the supply, distribution or use of energy.

This rulemaking does not involve technical standards under the NTTAA section 12(d), 15 U.S.C. 272.

Executive Order 12898 (59 FR 7629, February 16, 1994) directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations (people of color and/or Indigenous peoples) and low-income populations.

EPA believes that it is not practicable to assess whether the human health or environmental conditions that exist prior to this action result in disproportionate and adverse effects on people of color, low-income populations and/or Indigenous peoples. As explained in Unit II.B., asbestos exposure is a hazard to human health. This action establishes a one-time reporting requirement for asbestos that requires companies to report to EPA certain exposure-related information known to or reasonably ascertainable by those entities as discussed in detail in Unit IV.F. At this time, EPA is not able to provide an assessment of potential exposures that may be identified as a result of the one-time reporting requirement in this rule and thus cannot determine whether the human health or environmental conditions that exist prior to this action have the potential to result in disproportionate and adverse effects on people of color, low-income populations and/or Indigenous peoples. This action establishes a one-time reporting requirement and would not change any existing disproportionate and adverse effects on people of color, low-income populations and/or Indigenous peoples.

The information obtained as a result of this action may be used to support the ongoing EPA risk evaluation for asbestos, which may result in risk management activities. EPA also believes that the information obtained as a result of this action could be used by the public (including people of color, low-income populations and/or Indigenous peoples) to inform their behavior as it relates to sources of asbestos exposure or by government agencies and others to identify potential problems, set priorities, and take appropriate steps to reduce any potential human health or environmental risks.

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

Therefore, for the reasons set forth in the preamble, EPA is amending 40 CFR chapter I, Subchapter R as follows:

This final rule amends the NASA FAR Supplement (NFS) to change references to Title 10 of the U.S. Code. The William M. (Mac) Thornberry National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2021 (Pub. L. 116-283), contains Title XVIII, Transfer and Reorganization of Defense Acquisition Statutes, sections 1801-1885. Title XVIII, Sections 1801-1885, transfers, reorganizes (including making conforming changes), redesignates, and consolidates defense acquisition statutes into Part V of subtitle A, Acquisition, of Title 10 of the U.S. Code. Title XVIII also creates a more rational organization of acquisition statutes, loosely following the Federal Acquisition Regulation structure. The genesis of Title XVIII stems, in large part, from a Section 809 Panel recommendation to consolidate and reorganize all Department of Defense (DOD)-related acquisition statutes into a single Part V because the then-existing statutory structure was cumbersome, haphazardly arranged, confusing and difficult to navigate. Congress implemented a version of this recommendation when it established a new Part V in the FY 2019 NDAA, in Section 801—Framework for New Part V of Subtitle A, and Sections 806-809—Redesignation of Numerous DOD Statutes. The FY 2019 NDAA did not transfer statutes into the newly created Part V of Title 10. Title XVIII, sections 1801-1885, of the FY 2021 NDAA transfers existing Title 10 acquisition statutes into the Part V shell. FY 2021 NDAA Title XVIII sections 1801-1885 has an effective date of January 1, 2022.

This rule does not add any new solicitation provisions or contract clauses. This rule merely revises references to Title 10 of the U.S. Code in the NASA FAR Supplement (NFS) including in part 1852, as appropriate. It does not add any new burdens because the case does not add or change any requirements with which vendors must comply.

“Publication of proposed regulations”, 41 U.S.C. 1707, is the statute which applies to the publication of the Federal Acquisition Regulation. Paragraph (a)(1) of the statute requires that a procurement policy, regulation, procedure or form (including an amendment or modification thereof) must be published for public comment if it relates to the expenditure of appropriated funds, and has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure or form, or has a significant cost or administrative impact on contractors or offerors. This final rule is not required to be published for public comment, because NASA is not issuing a new regulation; rather, this rule is merely an editorial change to Title 10 of the U.S. Code in the NASA FAR Supplement (NFS).

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804 requirements with which vendors must comply.

The Congressional Review Act, 5 U.S.C. 801 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a “major rule” may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. A major rule cannot take effect until 60 days after it is published in the Federal Register . This rule has been reviewed and determined by OMB not to be a “major rule” under 5 U.S.C. 804(2).

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) does not apply to this rule, because an opportunity for public comment is not required to be given for this rule under 41 U.S.C. 1707(a)(1) (see section II. of this preamble). Accordingly, no regulatory flexibility analysis is required, and none has been prepared.

The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

Accordingly, 48 CFR parts 1803 and 1852 are amended as follows:

We are revising our regulations regarding seizure and administrative forfeiture of property and the disposal of any property forfeited or abandoned to the United States (whether through administrative or judicial forfeiture) under various laws that the Service administers. These regulations establish the procedures that we use for the seizure, bonded release, appraisement, administrative proceeding, petition for remission, and disposal of items subject to forfeiture and reflect the procedures required by CAFRA. This rule makes these regulations easier to understand using simpler language. This revision also more clearly explains the procedures used in administrative forfeiture proceedings, makes the process more efficient, and makes the Service's seizure and forfeiture procedures more uniform with those of other agencies subject to CAFRA.

The Service is not the only agency with seizure and administrative forfeiture authority. In general, all property subject to forfeiture under Federal law may be forfeited administratively by the enforcing Federal agency if the statutory authority for the forfeiture incorporates the Customs laws of 19 U.S.C. 1602 et seq., and if the property is neither real property nor personal property having a value of more than $500,000 (except as noted in 19 U.S.C. 1607(a)).

Since Congress enacted CAFRA in 2000, the Service has implemented that Act's requirements. For example, in written guidance that we issued in 2014 on providing notice of seizures and proposed forfeitures, we outlined administrative and judicial options to contest seizures and proposed forfeitures and advised which statutory deadlines apply (OLE Public Bulletin, Revision of Notice of Seizure and Proposed Forfeiture Letter, September 23, 2014). We are now updating the regulations in part 12 of title 50 of the Code of Federal Regulations (50 CFR part 12) to reflect these procedural changes.

We published a proposed rule on June 17, 2016, at 81 FR 39848. We held a 60-day public comment period on the proposed rule. After the comment period closed, we considered the comments, and we address them below. Today, we are finalizing the rule largely as proposed, with some minor changes.

The Service has enforcement and oversight responsibilities under Federal wildlife conservation laws and regulations. The regulations in 50 CFR part 12 establish procedures relating to property seized or subject to administrative forfeiture as well as to the disposal of any property forfeited or abandoned to the United States under various laws enforced by the Service. Authority to seize and conduct administrative forfeiture and/or to dispose of property forfeited or abandoned to the United States whether through administrative or judicial forfeiture is granted under the following statutes:

• the Bald and Golden Eagle Protection Act, 16 U.S.C. 668 et seq.;

• the National Wildlife Refuge System Administration Act, 16 U.S.C. 668dd et seq.;

• the Migratory Bird Treaty Act, 16 U.S.C. 703 et seq. (MBTA);

• the Migratory Bird Hunting and Conservation Stamp Act, 16 U.S.C. 718 et seq.;

• the Airborne Hunting Act, 16 U.S.C. 742j-1;

• the African Elephant Conservation Act, 16 U.S.C. 4201 et seq.;

• the Endangered Species Act of 1973, 16 U.S.C. 1531 et seq. (ESA);

• the Marine Mammal Protection Act of 1972, 16 U.S.C. 1361 et seq.;

• the Lacey Act, 18 U.S.C. 42;

• the Lacey Act Amendments of 1981, 16 U.S.C. 3371 et seq.;

• the Rhinoceros and Tiger Conservation Act, 16 U.S.C. 5301 et seq.;

• the Antarctic Conservation Act, 16 U.S.C. 2401 et seq.;

• the Archeological Resources Protection Act, 16 U.S.C. 470aa et seq.;

• the Paleontological Resources Preservation Act, 16 U.S.C. 470aaa et seq.; and

• the Native American Graves Protection and Repatriation Act, 25 U.S.C. 3001 et seq.

We note that the Service implements other statutes that may be enforced through the above-listed statutes. For example, importation in violation of the Wild Bird Conservation Act, 16 U.S.C. 4901 et seq., is also a violation of the Lacey Act Amendments of 1981. See 16 U.S.C. 4912(c).

CAFRA (Pub. L. 106-185; 18 U.S.C. 983) superimposes specific procedural requirements over the procedures in various forfeiture laws in existence prior to CAFRA's enactment. We are revising 50 CFR part 12 to reflect in one place the CAFRA procedural overlay and to make changes to increase the efficiency of the regulations, such as allowing the publication of notices through the internet and streamlining the process for claims and petitions for remission. The purposes of the civil forfeiture laws enforced by the Service are remedial, among other things, because forfeiture removes unlawful wildlife from society and is based upon the unlawful use of that wildlife.

We reviewed and considered all substantive information we received during the comment period on the proposed regulation revisions. We received five comments, two of which were identical. Below we summarize the substantive information in those public comments and our responses that explain why we do or do not incorporate the changes suggested by each commenter into this final rule. Comments supporting various provisions of the rulemaking are not included below. As comments were often similar or covered multiple topics, we grouped comments and responses by topic areas.

(1) Comment: Commenter stated that forfeiture has takings implication under Executive Order 12630 (Governmental Actions and Interference with Constitutionally Protected Property Rights; 53 FR 8859, March 18, 1988) and that exemptions alluded to by the Service contradict the spirit of E.O. 12630.

FWS Response: Executive Order 12630 specifically exempts seizure and forfeiture of property for violations of law. See E.O. 12630, sections 2(a)(3) (excluding from the takings implications law enforcement actions involving seizure, for violations of law, of property for forfeiture or as evidence in criminal proceedings) and 2(c) (excluding actions, including proposed Federal regulations and applications of Federal regulations to specific property, that are law enforcement actions involving seizure, for violations of law, of property for forfeiture or as evidence in criminal proceedings).

(2) Comment: Commenter stated that civil forfeiture is against constitutional rights to due process.

FWS Response: The Federal Government may forfeit people's property yet avoid violating their due process rights. There are two types of due process: procedural due process and substantive due process. Procedural due process concerns property owners' right to be notified of a seizure and a violation, and their right to be heard, i.e., to make their case. See United States v. James Daniel Good Real Property, 510 U.S. 43, 48 (1993). Substantive due process refers to the requirement that laws and regulations must be related to a legitimate government interest (as crime prevention) and may not contain provisions that result in the unfair or arbitrary treatment of an individual. Merriam-Webster.com Legal Dictionary, https://www.merriam-webster.com. Accessed March 7, 2023.

The final rule preserves property owners' procedural due process. If we seize property, 50 CFR 12.11 requires us to send property owners a notice of seizure and proposed forfeiture. Also, § 12.12 requires us to post public notice of seizure and proposed forfeiture. We wrote these sections with the intent to give property owners reasonable notice, as the law requires. Once a property owner receives a notice, they have a meaningful opportunity to be heard either by filing a petition for remission or by filing a claim, which removes the matter to court and converts it to judicial forfeiture. By incorporating notice and hearing into the rule, we have met the procedural due process requirements.

In this context, substantive due process generally concerns property owners' right to ownership in the property itself. If we seize property, we have made the preliminary determination that it is contraband. The United States Supreme Court has held that there are no fundamental property rights in contraband. See One 1958 Plymouth Sedan v. Pennsylvania, 380 U.S. 693 (1965). If we ultimately determine that property is contraband and forfeit the property, we do not deprive the property owner of their substantive due process right in the property.

(3) Comment: Commenter stated that no exemptions to CAFRA should be made.

FWS Response: The proposed part 12 regulations do not provide an exemption to CAFRA. They do, however, reflect certain exceptions that are written into and are part of CAFRA itself. Three of these CAFRA-mandated exceptions concern “contraband”: first, the release of property not properly noticed under 18 U.S.C. 983(a)(1)(F); second, the release of certain types of seized property under section 983(f); and third, the innocent owner defense in section 983(d). Two of these CAFRA-mandated exceptions concern “other property that is illegal to possess”: the release of certain types of seized property provisions contained in 18 U.S.C. 983(a)(1)(F) and the innocent owner defense of 18 U.S.C. 983(d). The part 12 regulations simply contain definitions of the terms “contraband” and “other property that is illegal to possess” that are used in these CAFRA-mandated exceptions.

(4) Comment: Commenter stated that FWS did not conduct a scoping notice before the publication of the proposed rule.

FWS Response: The Service conducted a review for the proposed rule in accordance with the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321 et seq.; NEPA), the Council on Environmental Quality (CEQ) NEPA regulations (40 CFR parts 1500-1508) and the Department of the Interior NEPA regulations (43 CFR part 46), and 516 Departmental Manual Chapters 1-4 and 8. Under 40 CFR 1501.9, scoping is required only for an environmental impact statement (EIS). The rule does not amount to a major Federal action significantly affecting the quality of the human environment; therefore, neither an EIS nor scoping is required. This rule is categorically excluded from further NEPA requirements under 43 CFR 46.210(i). This categorical exclusion addresses policies, directives, regulations, and guidelines that are of an administrative, financial, legal, technical, or procedural nature; or whose environmental effects are too broad, speculative, or conjectural to lend themselves to meaningful analysis and will later be subject to the NEPA process, either collectively or case-by-case.

(5) Comment: Commenter stated that the Service “fails to include a reference to animal welfare laws” in proposed § 12.70(c) and § 12.65 (which discuss disposal and destruction of forfeited and abandoned property).

FWS Response: We acknowledge that the Service must comply with all laws applicable to the destruction and disposal of fish, wildlife, and plants and any residue or wastes. Therefore, we are removing the modifiers “health, safety, and environmental protection” and have rewritten § 12.70(c) as follows: The Service will comply with all applicable laws regarding the destruction of the fish, wildlife, or plants and regarding the disposal of any residue or wastes resulting from the method of the destruction of the fish, wildlife, or plants.

(6) Comment: Commenter stated that the definition of “contraband” is too broad and should not include noncommercial goods that become unlawful to import due to harmless errors in the import process itself.

FWS Response: The definition of “contraband” in the proposed rule reflects the ordinary, common meaning of that term and judicial decisions that have construed the word “contraband” as used in CAFRA. Neither this common usage nor case law distinguishes between commercial and noncommercial goods. Several Federal wildlife protection laws apply not only to commercial but also to noncommercial import/export, transportation, use, and possession of wildlife and expressly provide for the seizure and forfeiture of wildlife involved in violations regardless of whether they occurred in connection with commercial activities. See, e.g., 16 U.S.C. 1538(c) (unlawful for any person to possess any specimens traded contrary to the provisions of the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)) and section 1540(e) (“all” fish or wildlife or plants involved in violations of the Endangered Species Act and its implementing regulations are subject to forfeiture to the United States); 50 CFR part 23 (Federal regulations implementing the trade protections for listed species provided through the CITES international treaty). Violations involving noncommercial property can and do make that property into contraband because of the manner or circumstances by which the noncommercial property is used.

Indeed, this was the situation in Conservation Force v. Salazar, 677 F. Supp. 2d 1203, 1207 (N.D. Cal. 2009), aff'd, 646 F.3d 1240 (9th Cir. 2011), where the District Court found that hunting trophies imported for noncommercial purposes had become contraband because they lacked valid CITES permits and so “the manner in which plaintiffs brought their trophies into the United States transformed the trophies into contraband.” As for the concern expressed by the commenter about “harmless errors,” this complaint was raised in the context of the importation of hunting trophies. In those cases, the violations giving rise to seizure typically are due to problems with required CITES documents. Maintenance of the integrity of the CITES permitting system is essential to the effectiveness of the entire system of wildlife trade restrictions established by CITES. Unless the system of permits and certificates used by CITES to enforce its trade restrictions is enforced uniformly, protected wildlife may be overexploited through international trade. See 50 CFR 23.1 and 23.4.

“Documentary violations are particularly troubling and significant in the CITES framework, where signatory nations attempt to monitor and conserve dwindling wildlife populations in an era of increased international trade.” Underwater Exotics, Ltd. v. Secretary of the Interior, 1994 U.S. Dist. LEXIS 2262 (D.D.C. 1994). CITES parties are directed by the treaty not to allow trade in CITES specimens except in accordance with CITES (CITES article II(4)), to enforce CITES through measures including “confiscation” of illegally traded specimens (CITES article VIII(1)), and as noted above it is unlawful for any person to possess any specimens traded contrary to the provisions of CITES (16 U.S.C. 1538(c); 50 CFR 23.13). The CITES parties have agreed that when specimens are exported or reexported in violation of CITES, the seizure and confiscation of such specimens are generally preferable to the definitive refusal of the import of the specimen. CITES Resolution Conf. 17.8 (Rev. CoP19).

(7) Comment: Commenter stated that the definitions of “contraband” and “other property that is illegal to possess” are overbroad, because they strip from ivory owners the CAFRA innocent owner defense that otherwise would protect them from the documentation requirements set under the African elephant section 4(d) rule.

FWS Response: We do not agree that the innocent owner defense would apply to items determined to be contraband. Further, the requirements of the African elephant 4(d) rule are not at issue in this rulemaking. When enacting the innocent owner defense in CAFRA (at 18 U.S.C. 983(d)), Congress specifically chose to exclude “contraband” as well as “other property that it is illegal to possess.” The proposed 50 CFR part 12 regulations simply apply this statutory decision made by Congress, implementing the exclusions for “contraband” and “other property that it is illegal to possess” set out in 18 U.S.C. 983(d)(4), and providing definitions reflecting the ordinary, common meaning of these terms and judicial decisions that have construed their use in CAFRA.

(8) Comment: Commenter takes the position that sport-hunted trophies imported with paperwork errors should not be considered contraband, and the innocent owner defense should apply. Commenter stated that the conclusion on page 39850 of the proposed rule (in the explanation of the definition of “contraband”) that the innocent owner defense does not apply is incorrect. Commenter describes United States v. 144,774 Lbs. of Blue King Crab, 410 F. 3d 1131, 1134 (9th Cir. 2005), cited on page 39850, as limited only to the second of the two phrases “contraband or other property illegal to possess” used in CAFRA to describe instances in which the innocent owner defense is unavailable due to the commenter's conclusion that the crab at issue in that case was illegally harvested and taken in violation of Russian law and thus an intentional violation of the Lacey Act. Second, the commenter stated that the defense's unavailability should be limited to commercial cases, as in 144,774 Lbs. of Blue King Crab. Commenter also stated that United States v. 1866.75 Bd. Ft. & 11 Doors & Casings, 587 F. Supp. 2d. 740, 750 (E.D. Va. 2008), does not apply because the shipment in that case was imported without any CITES paperwork. Commenter points to a definition of “contraband” found on page 39850 of the proposed rule (81 FR 39848, June 17, 2016): Courts have concluded that contraband includes property that, if not inherently illegal in nature, becomes illegal through the manner or circumstances by which it is used, possessed, or acquired. Commenter also states that hunting trophies are almost never illegally used, possessed, or acquired, but instead have errors in their permitting paperwork.

FWS Response: We cited United States v. 144,774 Lbs. of Blue King Crab, 410 F. 3d 1131 (9th Cir. 2005), to support the statement directly above the citation on page 39850 of the proposed rule (81 FR 39848, June 17, 2016) regarding the effect of Congress using two different phrases, separated by the word “or” to describe the circumstances under which the innocent owner defense is unavailable. As we stated on page 39850 and as the court did in 144,774 Lbs. of Blue King Crab, 410 F.3d at 1135, each of these phrases is separate and distinct from the other, and they mean two separate things. 144,774 Lbs. of Blue King Crab did not define the term “contraband” because the Ninth Circuit was able to conclude that the property seized was covered by the “other property illegal to possess” portion of the two phrases. Consistent with this express ruling of the Ninth Circuit (410 F.3d at 1135-36), the proposed regulations only cited (at page 38951) to 144,774 Lbs. of Blue King Crab as supporting the proposed definition of “other property illegal to possess” and not of the term “contraband.”

Although the commenter argues that 144,774 Lbs. of Blue King Crab should be read as being further limited to commercial cases, the holding of the court did not depend on the shipment at issue being commercial or illegally harvested as the comment suggests. Similarly, we cited 1866.75 Bd. Ft. & 11 Doors & Casings, 587 F. Supp. 2d. 740, 750 (E.D. Va. 2008), as support for the statement regarding the effect of Congress using two different phrases. The court in 1866.75 Bd. Ft. likewise determined that the wood in that case was “other property illegal to possess,” not contraband. The commenter's position that hunting trophies are almost never illegally used, possessed, or acquired, but instead may have errors in their permitting paperwork, misinterprets how we are defining contraband. Property imported without necessary, complete, error-free permits is illegally possessed. We addressed this issue in detail in our response to Comment 6.

(9) Comment: Commenter expressed concern with a statement in the proposed rule that the described approach to the innocent owner defense is consistent with pre-CAFRA case law and authority because CAFRA was meant to reform the errors and overreaching by government agencies.

FWS Response: Prior to the enactment of CAFRA, some but not all civil forfeiture statutes contained an innocent owner defense. To “provide such a defense for all federal civil forfeitures, to make that defense uniform, and to ensure that it offers protection in all appropriate cases,” CAFRA requires an innocent owner defense now be recognized in all civil forfeitures it covers. CAFRA, H.R. 106-192, 106th Cong., 1st Sess. at 15 (1999). The pre-CAFRA case law we reference on page 39850 continues to be relevant because it shows the rationale used over time by various Federal courts for rejecting a good-faith defense in the majority of pre-2000 wildlife forfeiture cases, including their recognition of the importance of strict permitting requirements to restrict trade in protected species and of the corresponding need to reject good-faith defenses if there is a violation of wildlife protection laws.

(10) Comment: Commenter stated that directed reexport should not be used as punishment for noncommercial trade when it is too late to correct the error.

FWS Response: Directed reexport is a remedial action, not a punishment. Refusal of clearance (resulting in return to the exporting or reexporting country) instead of confiscation generally is disfavored by the CITES Parties. For example, the CITES Parties have recommended in CITES Resolution Conf. 17.8 (Rev. CoP19) that importing countries “consider that the seizure and confiscation” of the specimens exported or reexported in violation of CITES to be “generally preferable to the definitive refusal of the import” of such specimens. Reexport creates a risk that specimens may reenter into illegal trade. Consequently, the CITES Parties also have recommended that, when an importing country refuses clearance of specimens, the exporting or reexporting country should take measures necessary to ensure that the specimens not reenter into illegal trade, including monitoring their return to the exporting or reexporting country and providing for their confiscation. CITES Resolution Conf. 17.8 (Rev. CoP19). Under some circumstances, it may be appropriate for the Service to allow reexport of wildlife imported in violation of Federal wildlife laws (and refused clearance by the Service) instead of pursuing forfeiture. We note that this course of action would not be allowed where the trade involved commercial activity with an Appendix I species. We are guided by the limited noncommercial purposes that the CITES Parties have provided for disposal of Appendix I specimens in CITES Resolution Conf. 17.8 (Rev. CoP19) and as provided in 50 CFR part 23.

(11) Comment: Commenter stated that value should not be determined by FWS, and that market value or the cost of acquisition should govern.

FWS Response: A market value may not be available in all instances, particularly those involving protected species that may not be legally sold in the United States. Likewise, the cost of acquisition may not reflect the actual value of the item (particularly for illegally acquired items). The definition of value in the proposed regulation takes these possibilities into account, providing that the Service will use the reasonable declared value or the estimated market value if there is a legal market for the property. For property that may not be sold in the United States, the Service may use other reasonable means. This approach to valuation is essentially the same as has been taken since 1982 in existing 50 CFR 12.12.

(12) Comment: Commenter stated that forfeiture should not be permitted unless and until criminal adjudication of guilt by court, and that property should be returned if no criminal charges are filed.

FWS Response: Congress has specifically authorized the use of administrative and civil judicial forfeiture procedures to forfeit property seized for violation of Federal law—not only by the Service but also by a variety of other Federal enforcing agencies. In general, all property subject to forfeiture under Federal law may be forfeited administratively by the enforcing Federal agency except for real property, personal property having a value of more than $500,000 (except as noted in 19 U.S.C. 1607(a)), and property forfeitable under a statute that does not incorporate the Customs laws of 19 U.S.C. 1602 et seq. Seized property also may be forfeited to the United States judicially, in civil and criminal judicial proceedings brought by the U.S. Department of Justice (DOJ). The statutes identified in § 12.2 grant the Service the authority to seize and conduct administrative forfeiture and/or to dispose of property forfeited or abandoned to the United States, whether through administrative or judicial forfeiture. Many of those statutes provide an administrative forfeiture remedy, and the Service is complying by following the requirements set forth in these statutes.

(13) Comment: Commenter stated that the proposed regulation's handling of notice relieves the Service of any duty to provide actual notice to accused violators of seizure by defining a “Declaration of Forfeiture” to include a “description of efforts made to deliver notice” instead of proof of actual notice.

FWS Response: The commenter references proposed § 12.13(b) for those circumstances when service of notice has been attempted, but it is effectively impossible. In that case, the declaration of forfeiture will describe the efforts made to deliver the notice of seizure and proposed forfeiture. However, the inclusion of that provision in § 12.13(b) does not mean that the Service has relieved itself of any duty to provide actual notice.

The proposed regulations at § 12.11(a) provide that the Service or the Solicitor will first send written notice of the seizure to each interested party by U.S. registered or certified mail, express mail, or commercial carrier, all with proof of delivery and return receipt requested. The notice will be sent to an address that has been provided on shipping or other documents accompanying the property or on the permit or license application, unless the Service or the Solicitor has actual notice of a different address. In addition, all seizures will be published either for at least 3 successive weeks in a generally circulated newspaper in the judicial district where the property was seized or on the official government internet site for at least 30 consecutive days (§ 12.12(a)). As a last resort, a property owner who does not receive a personal notice for any reason will have 30 days from the last posting of the public notice to file a petition for remission (§ 12.33(b)).

Finally, the notice provisions in part 12, subpart B, comply with the Supreme Court's ruling in Jones v. Flowers, 547 U.S. 220 (2006). Jones says that the government must take additional reasonable steps to notify a property owner if a first attempt at notice fails, if it is practicable to take additional steps. Id. at 225.

(14) Comment: Commenter questioned why the filing dates for the claimant's filing and for the government's filing are different and why the government gets the benefit of the “mailbox rule,” but the claimant does not.

FWS Response: The “mailbox” rule referred to by the commenter is a pre-CAFRA notion. The provisions for claimant's and the Government's filings are different because of the notice and filing requirements set by CAFRA. For example, 18 U.S.C. 983(a)(2)(B) provides that one of the dates used to set the deadline for a claimant to file a claim should run from the date the Government issues a notice of proposed forfeiture, while 18 U.S.C. 983(a)(2)(A) and 983(a)(2)(B) require that a claimant actually file a claim “with the appropriate official” by a specified date. Consistent with these provisions, § 12.4(a) of the regulations specifies filings from claimants must be received by the Service (and not mailed on or prior to) by specified dates. Several courts have found that claims are considered to be filed in a civil forfeiture action when received by the agency and not when mailed by the claimant. See, e.g., Sandoval v. United States, 2001 WL 300729 at *4 (S.D.N.Y. 2001).

(15) Comment: Commenter stated that the contents of the personal written notice sent to interested parties following seizure should contain a narrative statement of facts explaining the reason for the seizure. Commenter further stated that a reference to what laws and/or regulations were violated is not enough for a petitioner to respond to a notice of seizure.

FWS Response: Due process requires only that notice of a seizure and impending administrative forfeiture be “reasonably calculated, under all the circumstances, to apprise interested parties of the pendency of the action and afford them an opportunity to present their objections.” Lobzun v. United States, 422 F.3d 503, 507 (7th Cir. 2005) (quoting Mullane v. Cent. Hanover Bank & Trust Co., 339 U.S. 306, 314). The Service's notice of seizure and proposed forfeiture provides several pieces of information to the property owner. That information includes the port at which the property was seized, a description of the property and its value, citations to the regulations and laws violated, and the date of seizure. The information in the notice that the Service provides is sufficient for property owners to contest a seizure. Moreover, property owners should have additional information relevant to their shipments. A property owner may always contact the Service to ask for more information.

(16) Comment: Commenter stated it is unconstitutional to require a choice between filing a petition for remission or filing a claim.

FWS Response: While the commenter did not provide specific authority for the claim of unconstitutionality, we note that the comment was focused on due process concerns, which we addressed in comments 2 and 15 above. Under CAFRA, an interested party may choose to allow the forfeiture to proceed administratively or may compel the Government to initiate a judicial forfeiture action by filing a claim for the property. Moreover, several courts have considered due process claims challenging CAFRA's provision of alternative and not sequential remedies for administrative forfeiture and have upheld CAFRA's provisions, as described below. Malladi Drugs & Pharmaceuticals, Ltd. v. Tandy, 552 F.3d 885, 890 (D.C. Cir. 2009); Conservation Force v. Salazar, 677 F. Supp. 2d 1203, 1208 (N.D. Cal. 2009), aff'd, 646 F.3d 1240 (9th Cir. 2011).

Finding that the administrative remedy for forfeiture ( i.e., sought through a petition for remission) is distinct from the judicial remedy initiated through a claim, the Ninth Circuit concluded in Conservation Force v. Salazar, 646 F.3d 1240, 1242 (9th Cir. 2011), that applicable forfeiture statutes and regulations “provide alternative, not sequential, administrative and legal remedies for an administrative forfeiture.” The Ninth Circuit further concluded that, if a party pursues the administrative path, files a petition for remission, and the petition is denied, then the “exclusive remedy” for setting aside an administrative declaration of forfeiture is that provided in CAFRA, in 18 U.S.C. 983(e), and which is available only if the notice of forfeiture is not received. Put another way, if an interested party receives proper notice of a proposed administrative forfeiture and chooses to pursue an administrative path, filing a petition for remission that is reviewed and denied, then that party has “waived the opportunity for judicial forfeiture proceedings.” Id. The Ninth Circuit has followed its decision in Conservation Force in at least three subsequent opinions, United States v. Barnes, 647 Fed. Appx. 820, (9th Cir. 2016), Pert v. United States, 487 Fed. Appx. 396 (9th Cir. 2012), and Phillips v. United States, 464 Fed. Appx. 700 (9th Cir. 2011). Other courts have reached the same conclusion. See, e.g., United States v. Paulino, 2018 U.S. Dist. LEXIS 176893 (S.D.N.Y. Oct. 9, 2018); Martin v. Leonhart, 717 F. Supp. 2d 92 (D.D.C. 2010); Patterson v. Haaland, 2022 U.S. Dist. LEXIS 176407 (D.D.C. Sept. 28, 2022).

(17) Comment: Commenter stated that the notice of seizure and proposed forfeiture does not provide enough information to defend against, and claims are cost-prohibitive.

FWS Response: As discussed above, the contents of the notice of seizure and proposed forfeiture comply with the requirements of due process. The option of pursuing a claim is specifically provided for by statute, in CAFRA, as the judicial means of challenging a proposed forfeiture.

(18) Comment: Solicitors are not independent reviewers and often take the position that remission is to be granted too sparingly, even in cases of harmless error.

FWS Response: The Office of the Solicitor is a stand-alone office within the Department of the Interior and is separate and independent from the seizing bureau, the Service. Moreover, there is no doctrine of “harmless error” in forfeiture law. For cases involving illegal import of CITES species, CITES calls for strict enforcement, among other things, disfavoring the issuance of retrospective CITES permits (CITES Resolution Conf. 12.3 (Rev. CoP19)) and considering seizure and confiscation of specimens exported or reexported in violation of CITES to be generally preferable to refusal and reexport (CITES Resolution Conf. 17.8 (Rev. CoP19)). Decisions on petitions for remission made by the Solicitor's Office are equitable decisions based on the presumption that the underlying seizure was valid, and remission is discretionary. However, the Solicitor's Office will consider the factors listed in the rule in § 12.34 when making decisions, including whether there was an honest and good-faith intent to comply with the law and whether there are mitigating circumstances justifying remission.

(19) Comment: Commenter stated that the change to the practice of allowing the administrative process (petition for remission) and the judicial process (claim) for the return of seized property to proceed sequentially is not legally enforceable because no notice was published in the Federal Register .

FWS Response: Prior to October 7, 2014, the notice of seizure and proposed forfeiture used by the Service in administrative forfeiture proceedings advised interest holders that any petition for remission of forfeiture that interest holders submitted constituted a voluntary agreement that all forfeiture time periods would be suspended pending the outcome of the petition for remission, and in the event that a petition for remission was denied, the petitioner would be given the balance of time (if any) remaining to file a claim if the petitioner so chose. This opportunity to, in effect, suspend the period for filing a claim was provided by the Service as a matter of administrative discretion and not because of statutory mandate.

As discussed above in response to Comment 16, CAFRA itself provides alternative and not sequential remedies for administrative forfeiture. Effective October 7, 2014, the Service changed its notice letter to remove the provisions for suspending the period for filing a claim. This action was taken to address court decisions interpreting CAFRA, including, for example, the Ninth Circuit's decision in Conservation Force, 646 F.3d 1240 (9th Cir. 2011). The revision of the notice letter is not a binding rule, and consequently was not published for public notice and comment. Nevertheless, the Service did provide a written notice to the wildlife import/export community regarding this change to the notice letter. The notice was dated September 23, 2014, and was distributed to a list of interested parties as well as published on the FWS website on the Office of Law Enforcement's web page for Public Bulletins and Alerts (and currently available at https://www.fws.gov/library/collections/ole-public-bulletins ).

(20) Comment: Commenter stated that the holding in Conservation Force v. Salazar, 646 F.3d 1240 (9th Cir. 2011), is incorrect, and that the citation of Malladi Drugs & Pharmaceuticals, Ltd. v. Tandy, 552 F. 3d 885 (D.C. Cir. 2009), for the premise that the administrative remedy and the judicial remedy for the return of seized property are not sequential is distinguishable.

FWS Response: The Service disagrees, for the reasons discussed above.

(21) Comment: Commenter wrote that the statement in the proposed rule that “during the remission consideration, a valid seizure is presumed” is confusing and requested further clarification.

FWS Response: As stated further down on page 39853 (81 FR 39848, June 17, 2016), the statement that “during a remission consideration, a valid seizure is presumed,” means that forfeitability is presumed and the petitioner seeks relief from forfeiture on fairness grounds. In other words, “a petition for remission is a request for leniency, or an executive pardon, based upon the petitioner's representations of innocence or lack of knowledge of the underlying unlawful conduct.” Orallo v. United States, 887 F. Supp. 1367, 1370 (D. Haw. 1995). In contrast, the proper route for someone who wants to contest the legitimacy of the underlying forfeiture would be to file a judicial claim. See id. Note that we changed § 12.34(c) to reflect that the Solicitor will review the basis for the seizure, but this is a separate step from the remission consideration. See Summary of Changes from the Proposed Rule, below.

(22) Comment: Commenter stated that the discussion of petitions for remission being discretionary and retrospective CITES permits being disfavored violates CAFRA's proportionality requirement.

FWS Response: Remission or mitigation of penalties, fines, and forfeitures is discretionary. See 19 U.S.C. 1618. The text of CITES requires the grant of CITES documents prior to international trade and the presentation of valid CITES documents at the time of international trade in CITES specimens (CITES articles III-VII). The resolutions adopted by the Conference of the Parties to CITES have clearly stated that retrospective permits should be issued and/or accepted only in limited circumstances. See CITES Resolution Conf. 12.3 (Rev. CoP19). The proportionality section of CAFRA, 18 U.S.C. 983(g), allows a claimant to prove that a forfeiture is “grossly disproportional by a preponderance of the evidence at a hearing conducted by the court without a jury.” If the claimant meets the burden of proof and the court finds that the forfeiture is grossly disproportional to the offense, then the court shall reduce or eliminate the forfeiture “to avoid a violation of the Excessive Fines Clause of the Eighth Amendment of the Constitution.” Id . Thus, there are checks and balances in place to avoid a constitutionally excessive forfeiture. However, the fact that a petition for remission of forfeiture is denied or a retrospective CITES permit is not accepted does not equate to an automatic violation of CAFRA's proportionality requirement.

(23) Comment: Commenter inquired how the statement on page 39854 that forfeiture proceedings are brought against the guilty property itself and as such are in the nature of an in rem proceeding in which the property is the defendant and not the property owner works with Director's Order 212.

FWS Response: Director's Order 212 addresses using available legal and regulatory authority to deny wildlife violators ( i.e., those with prior violations of Federal wildlife protection laws) from obtaining Federal permits and licenses. Director's Order 212 says that the Director can use any information available that is relevant to the issue when considering a permit application under 50 CFR 13.21(d). Under that provision, the Service has discretion to consider past forfeitures that are relevant to the permit sought.

(24) Comment: Commenter stated that the requirement that a supplemental petition for remission be based on new evidence or evidence not previously considered would be more palatable if the original notice contained an adequate factual narrative.

FWS Response: As discussed above, the notice in current use by the Service as well as that required by the proposed regulations meets the requirements of due process.

(25) Comment: Commenter stated that it is not possible to include any documentary evidence relied upon when a claim is filed because the Service does not provide factual narratives when issuing notices of seizure and proposed forfeiture.

FWS Response: As discussed above, the Service's Notice of Seizure and Proposed Forfeiture meets the requirements of due process and complies with CAFRA. The Notice puts potential petitioners/claimants on notice as to the date and time of seizure, the laws relied upon as a basis for the seizure, and the options available to the petitioner/claimant.

(26) Comment: Commenter said there is an issue with the statement that the Solicitor will presume a valid seizure and will not consider whether the evidence is sufficient to support the seizure in determining whether remission should be granted because it suggests that the only way to challenge the legitimacy of a forfeiture is to go to court, which is a burden on hunters/owners.

FWS Response: The judicial route is not the only means of pursuing release of seized property. Either the administrative process (by filing a petition for remission with the Solicitor's Office) or the judicial process (by filing a claim with respect to the forfeiture, which causes the proposed forfeiture to be referred to the U.S. Attorney's Office for filing as a judicial forfeiture action) may be used to pursue release. However, the commenter is correct in that these two processes do provide different remedies: “A petition for remission `asks the agency for discretionary return of the property,' while a claim `initiate[s] the judicial process to decide whether the property should be forfeited.' ” Conservation Force v. Salazar, 646 F.3d 1240, 1242 (9th Cir. 2011) (quoting Malladi Drugs & Pharms., Ltd. v. Tandy, 552 F.3d 885, 889 (D.C. Cir. 2009)). Remission is an equitable remedy and is discretionary. See 19 U.S.C. 1618. Importantly, the Solicitor will follow the standards for remission in the rule at § 12.34 and consider the listed mitigating factors when deciding whether to return seized items. Also, as noted above, we made a change to § 12.34(c) noting that the Solicitor will review the basis for the seizure. We also explain this further below.

(27) Comment: Commenter stated that it is unlawful to require a claimant to file a civil judicial action requesting return of property pursuant to Federal Rules of Criminal Procedure (FRCP) Rule 41(g) when a judicial forfeiture action is not pursued within the required time period because CAFRA requires return of the property if a claim is not filed within 90 days. Commenter noted that there is no contraband exception to the 90-day requirement of subsection (a) of section 983 of CAFRA.

FWS Response: These two comments addressed § 12.38(b) and (c) of the proposed regulations. As we acknowledge below in Summary of Changes from the Proposed Rule, we removed those two paragraphs of § 12.38 for clarity and in response to the comments received.

This rule changes our procedures for seizure and forfeiture under the laws we enforce, listed above. This rule conforms our procedures to those in CAFRA, and it will clarify and better organize the provisions in 50 CFR part 12. Here, we present a summary of the final rule's provisions. In this summary, we do not attempt to capture every aspect of the final rule's changes to part 12. For more detailed descriptions of the changes and a section-by-section analysis, refer to the proposed rule (81 FR 39848, June 17, 2016).

In general, in this rulemaking, we reorganized, renamed, and removed some subparts and sections in 50 CFR part 12, as we proposed. The subpart titles below are the same as in the final regulatory text.

We expanded the list of laws to which the regulations apply, as indicated above; removed, revised, and added definitions of key terms; changed requirements for filing and issuing documents; clarified how we handle seizures made by other agencies; and clarified how we release seized property under a bond. Some, but not all, definitions of note that we added or revised include “contraband,” “directed reexport,” “other property that is illegal to possess,” “petition for remission,” and “value.” We added “contraband” to address an exemption to three CAFRA procedures—two regarding release, and one regarding the innocent owner defense. We added “directed reexport” to indicate explicitly that we may offer it for shipments that we refuse to clear for entry into the United States. Further, we included a definition of “other property that is illegal to possess” to highlight that two CAFRA exemptions regarding release do not apply to protected fish, wildlife, and plants, depending on circumstances, and “petition for remission,” as these regulations expand on the procedures for such petitions. We also revised the definition of “domestic value,” changing the term to “value,” and explained how we are responsible for assigning value to property seized, as well as how we will do so for property seized with and without a legal market value in the United States.

We are changing subpart B to clarify and update notification requirements and procedures in the case of seizure and proposed forfeiture. Electronic posting on our website is now an additional public notice method.

We clarify that there is a judicial and an administrative forfeiture option, the distinctions between them, and that they are mutually exclusive. We explain the standard for administrative forfeiture, how you will be notified of the Solicitor's decision on your petition for remission, and when you should file a supplemental petition. In this subpart, we also explain how to file a judicial claim for return of your property and for conditional return of your property while your claim is pending.

We clarify how property can be abandoned and whether you can request return of your abandoned property.

We added clarifications to most sections, and several remain largely the same as in the current regulations. We made more substantive changes to some sections, including, but not limited to, clarifying edits to indicate that forfeiture or abandonment ends the prior illegal status of property, but that owners must still comply with applicable laws. Other substantive changes include clarifying when we may dispose of forfeited or abandoned property to include donation to Tribes for traditional cultural practices, clarifying that we may reexport or destroy injurious species and recover associated costs, allowing donation of abandoned or forfeited property but not for human consumption, explaining when we may loan abandoned or forfeited property and that borrowers may not sell the property or its offspring, and that destruction of forfeited or abandoned wildlife must happen in accordance with applicable laws.

This subpart is largely unchanged from the prior version of the subpart.

We are making some minor changes from the proposed rule. The following paragraphs include descriptions of these changes that go beyond small grammatical changes to the regulatory text.

First, we removed the phrase “seized by the Service” in the definition of “abandon” in § 12.3, so the clause now reads: Abandon means to relinquish to the United States all legal right you have to own, claim, or possess property. . . . We made this change to clarify that voluntary abandonment is authorized. We added the phrase “or any other entity” in the definition of “authorized officer” to define the term more broadly. We also added the word “bred” to the definition of “contraband” in § 12.3, due to the passage of the Big Cat Public Safety Act on December 20, 2022, 117 Public Law 243, 136 Stat. 2336, which, among other prohibitions, makes it unlawful to breed any prohibited wildlife species as defined in that Act. Next, we are changing “sent” to “delivered” in the definition of “declaration of forfeiture” in § 12.3. Specifically, the clause will now read: if notice was never successfully delivered. That change aligns the clause logically with the remainder of the sentence, as we use the word “deliver” later in the sentence. We also removed the phrase “under the criteria in § 12.11(a)” in the definition of “interested party” in § 12.3, and we replaced the phrase with “in property.” Section 12.11(a), which is a notice provision, does not overtly state criteria that we use to identify interested parties, but it does describe ways the Service often identifies them. For example, we may infer that a person is an interested party based on their name and address appearing on shipping documents or on their permit or license application and send them a notice of seizure and proposed forfeiture. Thus, we made this change for clarity.

Next, we moved § 12.11(g)(1)-(2) to § 12.33(b) because the provisions concern deadlines for filing petitions for remission, not personal notification of seizure and forfeiture, so the heading of § 12.33 is a better fit.

We changed the heading of § 12.13 to “How is a declaration of forfeiture issued?” to better reflect the substance of the section. The previous heading implied that the section was only about the contents of the declaration of forfeiture.

We removed the requirement to provide a social security number or taxpayer identification number in a petition for remission. This requirement was in proposed § 12.33(c)(1). We do not need this information to manage or dispose of petitions. We also reworded § 12.33(d) and § 12.34(a) for clarity.

We revised § 12.34(b) to clarify that the petitioner carries the burden of proof for both initial petitions for remission and for supplemental petitions. Next, we address changes we are making to § 12.34(c): The first is a minor wording change regarding the scope of the information that the Solicitor will review. The proposed rule said that the Solicitor would consider any other available information relating to the matter, which arguably could unduly burden the Solicitor's Office with extensive independent investigating and fact-finding. We removed the word “any,” which is a reasonable choice given the extent of some of the cases that come before the Solicitor's Office that can involve many parties and several foreign countries. Moreover, the burden should be on the petitioner to bring the information to the Solicitor, as stated elsewhere in that section. We also qualified the type of information that the Solicitor will consider from the petitioner as “relevant” information; the Solicitor will not consider irrelevant information. Further, we clarified that the Solicitor will consider other information that is available to the Solicitor. Finally, we removed the first sentence of proposed § 12.33(h), which is inconsistent with these changes to § 12.34(c).

Second, we changed § 12.34(c) to reflect that a petitioner may submit relevant evidence showing that a seizure was invalid, and the Solicitor will consider that information. However, if nothing suggests the seizure was invalid or unlawful, the Solicitor will presume the seizure was valid. The first sentence of proposed § 12.34(c) stated that the Solicitor will presume that a seizure is valid and will not consider whether the evidence supports the seizure when considering a petition for remission. Our intent in drafting that sentence was to emphasize that remission is about equity, and that the standard for making a decision on the petition is based in equitable principles. We capture those principles in § 12.34(e). We also explain this issue in more detail in the proposed rule (81 FR 39848, June 17, 2016) at pages 39853-39854.

We made this change in the final rule because seizure and forfeiture must follow from a violation of the underlying law, whether it be the Endangered Species Act, the Lacey Act, or another law we enforce, and we need to follow the proper procedures in seizing and forfeiting the property. In first reviewing the seizure for validity, the Solicitor makes the determination that forfeiture should proceed. The Solicitor will confirm the existence of a violation and whether proper procedures were followed, among other things. Then the Solicitor will review the petition for remission, applying the equitable principles in § 12.34(e). We also amended the introductory language of § 12.34(e) for clarity.

This change provides property owners and petitioners with greater clarity on how we process petitions for remission. Specifically, they will understand that the Solicitor will review the underlying seizure before considering the petition. Relatedly, they will understand the value of submitting any evidence they have that questions the validity of the seizure.

Next, we added the phrase “but not limited to” to § 12.34(e)(3) to clarify that the Solicitor may consider cumulative conservation impacts other than the ones listed in § 12.34(e)(3).

Next, we removed proposed § 12.38(b) and (c) to better align § 12.38 with CAFRA requirements. If we seize property and send the owner a notice under § 12.11, one option for the owner is to file a claim under § 12.36. Filing a claim causes the Solicitor to refer the matter to DOJ. Under CAFRA, DOJ has 90 days to file a complaint for forfeiture, return the property, obtain a criminal indictment that includes a claim against the property, or otherwise comply with any applicable criminal forfeiture statute if DOJ chooses to hold the property. The property must be returned to the owner if DOJ does not do one of those things when 90 days have passed since the owner filed a claim.

Under proposed § 12.38(b), the Solicitor would send the owner a letter if 90 days had passed since the claim was filed and DOJ had not acted. We proposed that the letter would inform the owner that the 90 days had expired and state that, to have the property returned, the owner needed to file a motion under FRCP 41(g) in the district where the property was seized. We also proposed to publish a public notice, as in § 12.12, with the same information as the letter.

In proposed § 12.38(c), we stated that the disposal provisions in proposed §§ 12.61-12.70 would apply if a court determined that seized property was contraband or property illegal to possess under FRCP 41(g). We also stated that we would apply the disposal provisions if the owner did not file a motion for return of the property within 6 years of the Solicitor's letter and public notice.

We agree with the commenter who noted that CAFRA requires the government to release property to its owner if DOJ does not act after 90 days of the owner filing a claim, as explained above. CAFRA does not add any requirements beyond the expiration of the 90 days. It does not require agency counsel to send the owner a letter notifying the owner that the 90 days have expired or post a public notice, nor does it require the owner to file a motion under FRCP 41(g) for the government to return the owner's property. Therefore, those requirements in proposed § 12.38(b) are inconsistent with CAFRA, and we will not finalize proposed § 12.38(b).

Proposed § 12.38(c) followed proposed § 12.38(b) by stating how we would dispose of property if a court upheld the forfeiture of the owner's property under FRCP 41(g) or if the owner did not respond to the Solicitor's letter or public notice under proposed § 12.38(b). Because we are not finalizing proposed § 12.38(b), we are likewise not finalizing § 12.38(c).

Next, we are making a minor change to § 12.51, which addresses voluntary abandonment of seized property. The revised language clarifies that a property owner who wants to voluntarily abandon seized property may use a form other than the Service's Form 3-2096 or may write a letter, as long as the form or letter provides substantially the same information as the Service form. The previous language was less clear in terms of what an alternative form or letter needed to contain. Also, this revision will standardize the information that property owners must provide to abandon their property. We will treat all abandonments the same in this regard, which is fairer. It also ensures that we have the same information about each abandonment.

Next, we amended § 12.63(c) to clarify that there may be a variety of options regarding costs associated with returning confiscated specimens to the wild in countries with suitable habitat and in accordance with applicable law, such as requiring the violator or others, as provided by law, to meet the costs. CITES contemplates these options in Resolution Conf. 17.8 (Rev. CoP19), paragraph 5. We also amended § 12.63(c) for better flow and clarity.

Next, we streamlined language related to the applicable law in §§ 12.64(a), 12.67(b)(6), 12.68(b)(6), and 12.69(d) that speaks to duties of subsequent holders of abandoned or seized property. Specifically, the provisions note that subsequent holders of the property must follow applicable Federal, State, Tribal, and foreign laws and regulations. We deleted the phrase “or any applicable conservation, health, quarantine, agricultural, or Customs laws or regulations” because those applicable laws are covered by the revised text. We also noted that the Service may donate or loan property in §§ 12.67 and 12.68, respectively, when consistent with applicable law.

In addition to the revisions clarifying the applicable laws in §§ 12.67 and 12.68, we added “or their offspring” to §§ 12.67(b) and 12.68(b) to clarify that any offspring bred from live specimens donated or loaned by the Service is subject to all of the same requirements, consistent with the definition of “fish or wildlife” in 50 CFR 10.12.

We deleted § 12.67(b)(8), which concerned the re-transfer of donated property without the Service's prior authorization, because § 12.67(b)(7) already requires prior authorization for any subsequent transfers. We deleted the similarly worded clause in the next section, § 12.68(b)(8), which concerned the re-transfer of loaned property, for the same reason.

Next, we changed the reference to the genus of African elephants in § 12.69(a) to make it more general. Our proposed rule included both Loxodonta africana and Loxodonta cyclotis under the entry for African elephant in § 12.69(a)(7). However, we did not mean to imply that the species Loxodonta africana had been reclassified under the ESA or CITES. We note that the Service has been petitioned to reclassify the African elephant as endangered and to recognize two species of African elephants and classify them both as endangered under the ESA. Review of those petitions, through a process separate from this rulemaking, is ongoing. Accordingly, we are finalizing with the more general text “ Loxodonta species” to account for any future changes in taxonomy of the African elephant that might occur. We also added three statutes to § 12.69(a) limiting when the Service can sell forfeited or abandoned property: the Wild Bird Conservation Act, the Rhinoceros and Tiger Conservation Act, and the Big Cat Public Safety Act, because these statutes limit the commercialization of the species they protect.

Here we address the change we are making to § 12.70(c). We proposed to require ourselves to “comply with all Federal health, safety, and environmental protection laws” when destroying fish, wildlife, or plants or disposing of wastes or residues from destruction, as applicable. A commenter noted that we did not reference animal welfare laws and require ourselves to comply with them in disposing of and destroying animals. The commenter mentioned the Animal Welfare Act, 7 U.S.C. 2131 et seq. We acknowledge the commenter's concern, and we are revising the text at § 12.70(c) to require ourselves to comply with all laws applicable to destruction of fish, wildlife, and plants and disposal of residue or wastes. This language includes but is not limited to the Animal Welfare Act.

Lastly, we inadvertently proposed to remove current § 12.51, Return Procedure, from part 12. Current § 12.51 explains how property owners can get their property back from the Service if their petition for remission or claim is successful. Specifically, in repealing and replacing all of part 12, we neglected to bring current § 12.51 forward into the proposed rule, and by doing so, we proposed to remove it from part 12. Instead, we want to retain the substance of current § 12.51. Therefore, we are redesignating current § 12.51 as § 12.82 and including it in the final rule. We are also retitling it: How will my property be returned if my petition or claim is successful? We also made two minor wording changes: We changed “bailee” to “custodian” to use a more modern term, and we indicated that either the Solicitor or the Service may provide a property receipt for signature.

Executive Order (E.O.) 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will review all significant rules. OIRA has determined that this rule is not significant.

E.O. 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The Executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.

The Department has determined that this rule will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Neither a regulatory flexibility analysis nor a small entity compliance guide is required.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996), whenever an agency publishes a notice of rulemaking for any proposed or final rule, the agency must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities (such as small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency certifies the rule will not have a significant economic impact on a substantial number of small entities.

SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. We have examined this rule's potential effects on small entities as required by the Regulatory Flexibility Act. Most of the businesses that the Service will initiate administrative forfeiture proceedings against would be considered small businesses as defined under the Regulatory Flexibility Act. These businesses would be in many different economic sectors but would generally fall within the size standards established by the Small Business Administration for small businesses.

We have determined that this action will not have a significant economic impact on a substantial number of small entities because the purpose of this rule is to make our regulations governing the seizure, bonded release, appraisement, administrative proceeding, petition for remission, and disposal of items subject to forfeiture under laws administered by the Service, consistent with CAFRA. Small businesses will actually have more freedom in contesting administrative forfeitures if this proposed rule is finalized because CAFRA waived the requirement to file a cash bond before filing a claim for property. The changes we made to the proposed rule are minor and do not change the economic impact analysis or the impact on small entities. Therefore, we are certifying that this rule will not have a significant economic impact on a substantial number of small entities and that a regulatory flexibility analysis is not required.

This rule is not a major rule under 5 U.S.C. 804(2), the Congressional Review Act, as it will not have an annual effect on the economy of $100 million or more. Moreover, this rule will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. The changes to the regulations contained in this rule will ensure that 50 CFR part 12 complies with CAFRA, as well as clarify what procedures are available to claim items potentially subject to forfeiture. Finally, this rule does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises because foreign-based enterprises are subject to the same procedures as U.S.-based enterprises relating to property seized or subject to administrative forfeiture under various laws enforced by the Service.

Under the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ), this rule will not “significantly or uniquely” affect small governments. A small government agency plan is not required.

We are the lead agency for enforcing numerous conservation acts and Executive orders regulating wildlife trade through the declaration process, issuing permits to conduct activities affecting wildlife and their habitats, and carrying out U.S. obligations under CITES. No small government assistance or impact is expected as a result of this rule. The changes to the regulations contained in this rule will ensure that 50 CFR part 12 complies with CAFRA, as well as clarify what procedures are available to claim items potentially subject to forfeiture.

This rule will not produce a Federal requirement that may result in the combined expenditure by State, local, or Tribal governments of $100 million or greater in any year, so it is not a “significant regulatory action” under the Unfunded Mandates Reform Act. This rule will not result in any combined expenditure by State, local, or Tribal governments.

Under Executive Order 12630, this rule does not have significant takings implications, nor will it affect any constitutionally protected property rights. This rule has no private property takings implications as defined in Executive Order 12630 because the Executive Order specifically exempts seizure and forfeiture of property for violations of law.

Under Executive Order 13132, this rule does not have significant federalism effects. A federalism summary impact statement is not required. This rule will not have a substantial direct effect on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government because State wildlife agencies will forfeit items under their own applicable laws and regulations.

Under Executive Order 12988, the Office of the Solicitor has determined that this rule does not overly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order. The purpose of this rule is to simplify and update our regulations regarding seizure and forfeiture of property. Specifically, this rule has been reviewed to eliminate errors and ensure clarity, has been written to minimize lawsuits, provides a clear legal standard for affected actions, and specifies in clear language the effect on existing Federal law or regulation.

This rule does not contain collections of information that require approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995, (44 U.S.C. 3501 et seq. ). We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.

The Service has conducted a NEPA review in accordance with NEPA, the CEQ NEPA regulations (40 CFR parts 1500-1508) and the Department of the Interior NEPA regulations (43 CFR part 46), and the 516 Departmental Manual Chapters 1-4 and 8. This rule does not amount to a major Federal action significantly affecting the quality of the human environment. An environmental impact statement is not required. This rule is categorically excluded from further NEPA requirements under 43 CFR 46.210(i). This categorical exclusion addresses policies, directives, regulations, and guidelines that are of an administrative, financial, legal, technical, or procedural nature; or whose environmental effects are too broad, speculative, or conjectural to lend themselves to meaningful analysis under NEPA and will later be subject to the NEPA process, either collectively or case-by-case. We have also determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA.

Section 7 of the ESA, as amended (16 U.S.C. 1531 et seq. ), provides that Federal agencies shall “ensure that any action authorized, funded or carried out . . . is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of (critical) habitat.” This rule changes our administrative and seizure and forfeiture procedures and more closely aligns them with CAFRA. It is strictly administrative in nature and has no effect on endangered or threatened species. As a result, no section 7 consultation is required for this rule.

Under the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175, and 512 DM 2, we have evaluated this rule and have determined that there are no substantial direct effects on federally recognized Native American Tribes or on the government-to-government relationship between the Federal Government and Native American Tribes. Therefore, consultation under the Department's Tribal consultation policy is not required. This rule changes aspects of our seizure and forfeiture procedures, but it is strictly administrative in nature and will not affect how we enforce the underlying laws protecting fish, wildlife, and plants. For this reason, it also will not be more or less protective of Tribal trust resources. Further, individual Tribal members are subject to the same procedures as other individuals relating to property seized or subject to administrative forfeiture under various laws enforced by the Service, except for § 12.65(a)(2), which is wholly beneficial to Tribal members. Under that provision, we may transfer forfeited wildlife to a Tribe.

Executive Order 13211 requires agencies to prepare statements of energy effects when undertaking certain actions that significantly affect energy supply, distribution, and use. Because this rule applies only to U.S. Government administrative forfeiture procedures, it is not a significant regulatory action under Executive Order 12866 and is not expected to significantly affect energy supplies, distribution, and use. Therefore, this action is not a significant energy action, and no statement of energy effects is required.

For the reasons described above, we revise part 12, subchapter B of Chapter I, title 50 of the Code of Federal Regulations to read as follows: