Rural Development is a mission area within the USDA comprising RUS, Rural Housing Service, and Rural Business-Cooperative Service. Rural Development's mission is to increase economic opportunity and improve the quality of life for all rural Americans. The mission is met by providing loans, loan guarantees, grants, and technical assistance through numerous programs aimed at creating and improving housing, business, and infrastructure throughout rural America.

The final rule that published February 6, 2023 (88 FR 7557), included a 60-day comment period that ended on April 7, 2023. The intent of the changes outlined in the final rule are to update regulations, clarify audit policy, and streamline procedures. The uniformity and consistency for all awardees should benefit both the awardees and Agency. Professional standards and guidance provide a framework for conducting high quality audits.

The Agency received comments from 3 respondents. The following are the comments received and the Agency's responses:

Respondent One: Aurélien Enthoven.

Comment: The “Policy on Audits of Awardees” should address the disparate impact of the RUS on Native American Tribe borrowers.

Agency response: We disagree. This policy is specific to RUS Awardees who do not meet the requirements of non-Federal entities subject to 2 CFR part 200, subpart F. Per 2 CFR 200.1, the definition of non-Federal entity is a State, local government, Indian tribe, Institution of Higher Education (IHE), or nonprofit organization that carries out a Federal award as a recipient or subrecipient.

Respondent Two: Eide Bailly, CPAs and Business Advisors.

Comment (1): We believe that revising 7 CFR 1773.3(e) to read as follows would further clarify RUS's audit requirements for nonprofit organizations: “ Subpart F of 2 CFR part 200 shall apply to audits of RUS electric and telecommunications cooperatives and for-profit telecommunications awardees only if the awardee has expenditures of federal awards from Federal agencies other than the Department of Agriculture RUS and has contractually agreed with another Federal agency ( e.g., Federal Emergency Management Agency) to provide a financial audit performed in accordance with 2 CFR part 200, subpart F. If the awardee has expenditures of federal awards from Federal agencies other than the Department of Agriculture RUS, all applicable Department of Agriculture RUS expenditures shall be included in the audit performed in accordance with 2 CFR part 200, subpart F .”

Agency response (1): We disagree with the comment. This policy is specific to all RUS electric and telecommunication Awardees, which are defined as entities that have an outstanding RUS or Federal Financing Bank (FFB) loan or loan guarantee and/or a continuing responsibility under a grant agreement with RUS. The language in § 1773.3(e) uses language to clarify when the audit should not be in accordance with 2 CFR part 200, subpart F. We believe the current language in § 1773.3(e) is sufficient as it relates specifically to RUS electric and telecommunications awardees only.

Comment (2): The requirement in 1709.21(a), 1719.13(b), 1734.8(a), 1738.254(b)(1), and 1739.20(a) conflict with other guidance because it requires all nonprofit organizations to obtain a Uniform Guidance audit in accordance with 2 CFR 200 Subpart F; however, it appears that RUS's updates intend to impose a Uniform Guidance audit requirement on a nonprofit organization receiving RUS funding only when the nonprofit organization has received other Federal awards that would require the performance of the audit in accordance with 2 CFR 200 Subpart F.

Agency response (2): We disagree with the comment. We do not believe this language creates a conflict, as the primary language in §§ 1709.21(a), 1719.13(b)(1), 1734.8(a), 1738.254(b)(1), and 1739.20(a) states that if the awardee (borrower, grantee, or recipient) is a for-profit entity, an electric or telecommunications cooperative, or any other entity not covered by paragraph (b) (paragraph (b)(2)), the recipient shall provide an independent audit report in accordance with 7 CFR part 1773.

And paragraph (b) (paragraph (b)(2)) states that if the awardee (borrower, grantee, or recipient) is a non-Federal entity, as defined in 2 CFR 200.1, the awardee shall provide an audit in accordance with subpart F of 2 CFR part 200.

The Agency believes this language is sufficient.

Respondent Three: American Institute of CPAs (AICPA). This respondent provided a detailed response with the following items highlighted as their overarching comments:

Comment (1): (1) Clarify what the effective date means for borrowers.

Agency response (1): Thank you for pointing this out. We will provide additional guidance on the website to assist in explaining the effective date. In addition, RUS will notify current awardees of the revisions to this part.

Comment (2): RUS should be aware that the Government Accountability Office has issued an Exposure Draft that proposes changes to the Government Auditing Standards (GAS).

Agency response (2): The Agency acknowledges that the standards are being revised and will review those changes, when available, to see what changes that may entail. However, the desire is not to hold these needed revisions up until such time as updates are done and have been analyzed to determine what changes RUS needs to make.

Comment (3): Paragraphs 1773.9 and 1773.32 include details about the GAS that fail to accurately reflect the requirements and mischaracterize that the results of an audit are an opinion of the effectiveness of internal controls and the role of the audit.

Agency response (3): RUS agrees to amend the language in §§ 1773.9(b) and 1773.32(a) introductory text and (a)(2) and (3) with the next revision. This language was in the current version and has not been changed or amended with this revision. RUS disagrees with the suggested removal of § 1773.32(a)(4) and believes the current language is sufficient.

Comment (4): Other sections of 1773 are overly prescriptive. (a) Part 1773.40 seems to require that audit documentation evidence that all regulatory assets and liabilities be tested for compliance which implies that sampling is not acceptable. That is not consistent with standard auditing procedures. (b) Similar issues exist in Parts 1773.42 and 1773.45.

Agency response (4): Sections 1773.40 and 1773.45 were not amended thru this final rule and therefore, these sections were not open for public comment. Sections 1773.40 and 1773.45 apply to all RUS Electric and Telecom awardees, stating they must follow Financial Accounting Standards Board (FASB) requirements. Electric awardees have additional requirements to receive RUS approval for all regulatory assets or liabilities. Section 1773.42 was amended to remove all contents and reserve the section.

Comment (5): The amendment to Parts 1719.13(b)(1) and 1738.254 includes an incorrect reference to 1773.5 and should be 1773.4.

Agency response (5): RUS agrees. The reference in §§ 1719.13(b) and 1738.254(b) will be amended to § 1773.4 in the next revision. RUS does not consider this a significant deviation because while § 1773.4 addresses RUS approval of the auditor, § 1773.5 references the specific requirements for an auditor to be considered satisfactory to RUS.

Comment (6): Amendment to Part 1770.13(a) does not agree with changes made to 1773.3.

Agency response (6): The only change made to § 1770.13(a) was to remove the title of 7 CFR part 1773 in the last sentence. Your comments will be considered in future revisions to these parts.

Comment (7): RUS uses the terms must, shall and should in the various parts impacted by the FR notice. We recommend RUS eliminate “shall” throughout the various Parts, define what is meant by “must” and “should” and then ensure the appropriate term is used throughout the Parts.

Agency response (7): We understand your concern. We are leaving the final rule as is, but will look at the use of must, should, and shall for when future updates are made.

Comment (8): We believe the RUS intent is to not include any appendices or exhibits to Part 1773. However, we noted the following document on the USDA website at: https://www.rd.usda.gov/files/UET_Bulletin_1773-1.pdf. This document appears to include several exhibits including illustrative auditor reports. If RUS plans to include any type of exhibit including information that would be issued by the auditor, we ask that the AICPA be provided an opportunity before it is issued.

Agency response (8): The RUS Bulletin 1773-1 will be officially rescinded when this final rule becomes effective. The Agency will ensure the bulletin is removed from the website.

The Agency appreciates the time that AICPA took to review, comment and question each section and will use that when the Agency next looks to update these sections.

No change to the rulemaking is necessary at this time. The RUS appreciates the comments received. The Agency confirms the final rule without change.

EASA, which is the Technical Agent for the Member States of the European Union, has issued a series of ADs, the most recent previously being EASA AD 2021-0012, dated January 11, 2021 (EASA AD 2021-0012), to correct an unsafe condition for certain Airbus Model AS332C, AS332C1, AS332L, AS332L1, AS332L2, and EC225LP helicopters.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to Airbus Model AS332C, AS332C1, AS332L, AS332L1, AS332L2, and EC225LP helicopters. The NPRM published in the Federal Register on February 8, 2023 (88 FR 8238). The NPRM was prompted by modifications developed by Airbus to address a report of an emergency exit window that required excessive pushing force to jettison. The NPRM proposed to require accomplishing the actions specified in EASA AD 2021-0012, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this AD and except as discussed under “Differences Between this AD and EASA AD 2021-0012. The FAA is issuing this AD to address the unsafe condition on these products.

After the NPRM was issued, EASA AD 2021-0012 was revised with EASA AD 2021-0012R1, dated February 25, 2023 (EASA AD 2021-0012R1) to include an alternate method to modify the window jettisoning system. Because operators may request an alternate method of compliance for accomplishing the requirements of this AD, the FAA is not incorporating by reference EASA AD 2021-0012R1 but is incorporating by reference EASA AD 2021-0012 as proposed in the NPRM.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2023-0160.

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.

EASA AD 2021-0012 requires modifying the windows jettisoning system.

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

The FAA reviewed Airbus Alert Service Bulletin (ASB) No. AS332-56.00.16, Revision 0, dated February 10, 2020, Airbus ASB No. AS332-56.00.18, Revision 0, dated September 23, 2020, Airbus ASB No. AS332-56.00.20, Revision 0, dated September 23, 2020, Airbus ASB No. AS332-56.00.21, Revision 0, dated September 23, 2020, Airbus ASB No. AS332-56.90.14, Revision 0, dated April 10, 2019, Airbus ASB No. EC225-56A013, Revision 1, dated February 10, 2020, Airbus ASB No. EC225-56A015, Revision 0, dated February 10, 2020, Airbus ASB No. EC225-56A016, Revision 0, dated February 10, 2020, and Airbus ASB No. EC225-56A017, Revision 0, dated February 10, 2020. This service information specifies procedures for modifying the windows jettisoning system. Depending on your helicopter configuration, the service information specifies procedures for removing PTFE tape (if installed), discarding certain internal seal keys and external extraction tapes, installing plugs on certain snap fasteners, removing certain emergency exit installation indications, measuring the thickness of certain windows, replacing certain windows, measuring the clearance between certain windows and the airframe, modifying certain assemblies of the external extraction tape with its associated marking (if necessary), and replacing certain polychloroprene seals with silicone seals.

The FAA also reviewed EASA AD 2021-0012R1, which requires modifying the windows jettisoning system and provides an alternate method for modifying the window jettisoning system than that required in EASA AD 2021-0012.

EASA AD 2021-0012 requires compliance within 250 flight hours or 6 months for certain helicopters not operated over water and within 110 flight hours or 6 months for certain other helicopters operated over water. EASA AD 2021-0012 also requires compliance within 25 months for all other affected helicopters. However, this AD requires compliance within 110 hours time-in-service for all helicopters.

Where the service information referenced in EASA AD 2021-0012 specifies discarding parts, this AD requires removing those parts from service. The service information referenced in EASA AD 2021-0012 specifies contacting Airbus Helicopter to obtain a technical solution, whereas this AD requires repair done in accordance with a method approved by the FAA, EASA, or Airbus Helicopters' EASA Design Organization Approval. The service information referenced in EASA AD 2021-0012 specifies using a video, whereas this AD does not.

This AD also prohibits installing a jettisonable window unless the actions required by this AD have been accomplished, whereas EASA AD 2021-0012 does not require any installation limitations.

The FAA estimates that this AD affects 39 helicopters of U.S. Registry. Labor costs are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this AD.

Modifying a window takes about 2 work-hours and parts cost about $220 for an estimated cost of $390 per window. There may be up to twelve affected windows on a helicopter for an estimated cost of up to $4,680 per helicopter and up to $182,520 for the U.S. fleet.

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 would modify the Air Traffic Service (ATS) route structure as necessary to preserve the safe and efficient flow of air traffic within the National Airspace System.

The FAA published a notice of proposed rulemaking for Docket No. FAA-2022-1586 in the Federal Register (87 FR 75974; December 12, 2022), amending VOR Federal airway V-171 due to the planned decommissioning of the VOR portion of the Roseau, MN, VOR/DME NAVAID. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received.

VOR Federal airways are published in paragraph 6010(a) 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. This amendment action 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 VOR Federal airway V-171 due to the planned decommissioning of the VOR portion of Roseau, MN, VOR/DME NAVAID. The airway action is described below.

V-171: V-171 extends between the Lexington, KY, VOR/DME and the Joliet, IL, VOR/DME; and between the Nodine, MN, VOR/Tactical Air Navigation (VORTAC) and the Roseau, MN, VOR/DME. The airway segment between the Grand Forks, ND, VOR/DME and the Roseau, MN, VOR/DME is removed. As amended, the airway extends between the Lexington VOR/DME and the Joliet VOR/DME; and between the Nodine VORTAC and the Grand Forks VOR/DME.

The NAVAID radials contained in the V-171 airway description below are unchanged and stated in degrees True north.

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 action of amending VOR Federal airway V-171, due to the planned decommissioning of the VOR portion of the Roseau, MN, VOR/DME NAVAID, 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); 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 environment impact 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. 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:

In the Federal Register of April 14, 2023 (88 FR 22907), in FR Doc. 2023-07723, the following correction is made:

On page 22908, in the first column, under DATES , the compliance date is corrected to read: “January 1, 2024”.

On February 24, 2023, the Department of Labor (DOL or Department), the Internal Revenue Service (IRS) and the Pension Benefit Guaranty Corporation (PBGC) published Federal Register notices that announced changes to the Form 5500 Annual Return/Report of Employee Benefit Plan and Form 5500-SF Short Form Annual Return/Report of Small Employee Benefit Plan. For DOL, the final rule included a Notice of Final Forms Revisions (Final Forms Revisions) jointly issued by the DOL, IRS and PBGC, and a DOL-only Final Rule (Final Rule) that made corresponding changes to the DOL annual reporting regulations under Title I of ERISA. 1

Pursuant to the Congressional Review Act (CRA), OMB designated the final rule as a “major rule,” as defined by 5 U.S.C. 804(2). 2 The changes to the annual return/report forms, instructions, and regulations are applicable to annual return/reports for plan years beginning on or after January 1, 2023, (see 88 FR 11984). Annual return/reports generally are due to be filed beginning seven months after the end of the applicable plan year ( e.g., July 31, 2024, for 2023 annual return/reports for calendar year plans). The Final Rule had a stated effective date of April 25, 2023, (see 88 FR 11793).

The Final Rule included additions to the ERISA annual reporting regulations to implement the directive to the Secretary of Labor in section 202 of the Setting Every Community Up for Retirement Enhancement Act of 2019, commonly known as the SECURE Act, to jointly with the Secretary of the Treasury provide for a single, consolidated Form 5500 filing option that would satisfy the annual reporting obligations for the defined contribution pension plans participating in a Defined Contribution Group (DCG) reporting arrangement. The Final Rule included newly added regulations at 29 CFR 2520.103-14 and 2520.104-51 setting forth requirements applicable to the DCG reporting arrangement, the participating plans, and the content of the consolidated Form 5500 filing.

The CRA requires that before a final rule can take effect it must be submitted to the Senate and the House of Representatives and to the Government Accountability Office (GAO), along with a concise general statement of the rule and its effective date. 3 Under the CRA, as pertinent here, the effective date of a major rule (which corresponds to an operational date in a Federal Register rule document) must be no earlier than “the later of the date occurring 60 days after the date on which . . . the Congress received the [required] report . . . or . . . the rule is published in the Federal Register . . . .” As noted above, the Final Rule and Final Forms Revisions were designated as a major rule for DOL and were published in the Federal Register on February 24, 2023. Although the report to GAO was delivered via the GAO electronic process for CRA submissions  4 on February 24, 2023, the Congressional Record reflects that the House received the final rule on February 28, 2023, 169 Cong. Rec. H1111 (daily ed. Mar. 3, 2023), and the Senate on March 6, 2023, 169 Cong. Rec. S858 (daily ed. March 21, 2023). As noted above, the Final Rule's notice at 88 FR 11793 published on February 24, 2023, in the Federal Register , has a stated effective date of April 25, 2023 (which means that the Federal Register rule's operational date was also April 25, 2023). Therefore, based on the dates of House and Senate receipt, that stated CRA effective date is earlier than 60 days after the receipt by Congress of the published final rule. In light of the fact that the April 25 effective date has passed, this final rule changes the operational date of April 25, 2023 to May 31, 2023, a date that is later than 60 days after receipt of the published rule by Congress.

The Final Rule added 29 CFR 2520.103-14 as a new annual reporting regulation that sets forth requirements for the consolidated annual report for a DCG reporting arrangement. The preamble of the Final Rule stated that paragraph (c) of § 2520.103-14 provides that DCG reporting arrangements must comply with the electronic filing requirements that apply to all plan filers and direct filing entities, including the requirement that the common plan administrator of all the participating plans that is filing the consolidated Form 5500 must maintain an original copy, with all required signatures, as part of its records (which also would be treated as records of each of the participating plans). The published regulatory text, however, omitted paragraph (c) and designated the paragraph as paragraph (d). The Department is correcting the paragraph lettering to designate the paragraph as paragraph (c).

Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), an agency is required to publish a notice of the proposed rule in the Federal Register before the provisions of a rule take effect. In addition, section 553(d) of the APA mandates a 30-day delay in effective date after issuance or publication of a substantive rule. Sections 553(b)(3)(B) and 553(d)(3) of the APA provide for exceptions from the APA notice and comment, and delay in effective date requirements. Section 553(b)(3)(B) of the APA authorizes an agency to dispense with normal notice and comment rulemaking procedures for good cause if the agency makes a finding that the notice and comment process is impracticable, unnecessary, or contrary to the public interest, and includes a statement of the finding and the reasons for it in the rule. Similarly, section 553(d)(3) of the APA allows the agency to avoid the 30-day delay in effective date where good cause is found and the agency includes in the rule a statement of the finding and the reasons for it.

The Department is publishing the change of the operational date without advance notice or an opportunity for comment because it falls under the “good cause” exemption of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B). Undertaking notice and comment procedures to incorporate the corrections in this document would be contrary to the public interest because it is in the public interest to timely provide a final rule that accurately reflects changes to the annual return/report forms, instructions, and regulations that are applicable to annual return/reports for plan years beginning on or after January 1, 2023. Further, such procedures would be unnecessary because the Department is not making substantive revisions to the Final Rule, but rather, it is changing the operational date by 36 days from April 25, 2023, to May 31, 2023, to reflect the CRA requirement that the effective date be no earlier than 60 days from receipt of the rule by the Congress. The Department, accordingly, finds good cause under 5 U.S.C. 553(b)(3)(B) to waive public comment. For the same reasons, the Department similarly finds good cause under 5 U.S.C. 555(d)(3) to avoid the 30-day delay in effective date after issuance of a substantive rule. 5

For the reasons discussed in the preamble, 29 CFR part 2520 is amended as follows:

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

On July 1, 2014, OFAC issued the South Sudan Sanctions Regulations, 31 CFR part 558 (79 FR 37190, July 1, 2014) (the “Regulations”), to implement Executive Order (E.O.) 13664 of April 3, 2014, “Blocking Property of Certain Persons With Respect to South Sudan” (79 FR 19283, April 7, 2014), pursuant to authorities delegated to the Secretary of the Treasury in E.O. 13664. The Regulations were initially issued in abbreviated form for the purpose of providing immediate guidance to the public. OFAC is revising the Regulations to further implement E.O. 13664. OFAC is amending and reissuing the Regulations as a more comprehensive set of regulations that includes additional interpretive guidance and definitions, general licenses, and other regulatory provisions that will provide further guidance to the public. Due to the number of regulatory sections being updated or added, OFAC is reissuing the Regulations in their entirety.

On April 3, 2014, the President, invoking the authority of, inter alia, the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq. ) (IEEPA), issued E.O. 13664. In E.O. 13664, the President found that the situation in and in relation to South Sudan, which has been marked by activities that threaten the peace, security, or stability of South Sudan and the surrounding region, including widespread violence and atrocities, human rights abuses, recruitment and use of child soldiers, attacks on peacekeepers, and obstruction of humanitarian operations, poses an unusual and extraordinary threat to the national security and foreign policy of the United States and declared a national emergency to deal with that threat.

Section 1(a) of E.O. 13664 blocks, with certain exceptions, all property and interests in property that are in the United States, that come within the United States, or that are or come within the possession or control of any U.S. person of: any person determined by the Secretary of the Treasury, in consultation with the Secretary of State: (i) to be responsible for or complicit in, or to have engaged in, directly or indirectly, any of the following in or in relation to South Sudan: (A) actions or policies that threaten the peace, security, or stability of South Sudan; (B) actions or policies that threaten transitional agreements or undermine democratic processes or institutions in South Sudan; (C) actions or policies that have the purpose or effect of expanding or extending the conflict in South Sudan or obstructing reconciliation or peace talks or processes; (D) the commission of human rights abuses against persons in South Sudan; (E) the targeting of women, children, or any civilians through the commission of acts of violence (including killing, maiming, torture, or rape or other sexual violence), abduction, forced displacement, or attacks on schools, hospitals, religious sites, or locations where civilians are seeking refuge, or through conduct that would constitute a serious abuse or violation of human rights or a violation of international humanitarian law; (F) the use or recruitment of children by armed groups or armed forces in the context of the conflict in South Sudan; (G) the obstruction of the activities of international peacekeeping, diplomatic, or humanitarian missions in South Sudan, or of the delivery or distribution of, or access to, humanitarian assistance; or (H) attacks against United Nations missions, international security presences, or other peacekeeping operations; (ii) to be a leader of (A) an entity, including any government, rebel militia, or other group, that has, or whose members have, engaged in any of the activities described in subsection 1(a)(i) of E.O. 13664 or (B) an entity whose property and interests in property are blocked pursuant to E.O. 13664; (iii) to have materially assisted, sponsored, or provided financial, material, logistical, or technological support for, or goods or services in support of (A) any of the activities described in subsection 1(a)(i) of E.O. 13664 or (B) any person whose property and interests in property are blocked pursuant to E.O. 13664; or (iv) to be owned or controlled by, or to have acted or purported to act for or on behalf of, directly or indirectly, any person whose property and interests in property are blocked pursuant to E.O. 13664. The property and interests in property of the persons described above may not be transferred, paid, exported, withdrawn, or otherwise dealt in.

In Section 2 of E.O. 13664, the President determined that the making of donations of the type of articles specified in section 203(b)(2) of IEEPA (50 U.S.C. 1702(b)(2)), by, to, or for the benefit of any person whose property and interests in property are blocked pursuant to E.O. 13664 would seriously impair the President's ability to deal with the national emergency declared in E.O. 13664. The President therefore prohibited the donation of such items.

Section 3 of E.O. 13664 provides that the prohibition on any transaction or dealing in blocked property or interests in property includes the making of any contribution or provision of funds, goods, or services by, to, or for the benefit of any person whose property and interests in property are blocked pursuant to E.O. 13664, and the receipt of any contribution or provision of funds, goods, or services from any such person.

Section 5 of E.O. 13664 prohibits any transaction that evades or avoids, has the purpose of evading or avoiding, causes a violation of, or attempts to violate any of the prohibitions set forth in E.O. 13664, as well as any conspiracy formed to violate such prohibitions.

Section 8 of E.O. 13664 authorizes the Secretary of the Treasury, in consultation with the Secretary of State, to take such actions, including the promulgation of rules and regulations, and to employ all powers granted to the President by IEEPA as may be necessary to carry out the purposes of E.O. 13664. Section 8 of E.O. 13664 also provides that the Secretary of the Treasury may redelegate any of these functions to other officers and agencies of the U.S. government. In furtherance of the purposes of E.O. 13664, OFAC is revising 31 CFR part 558.

The Regulations implement targeted sanctions that are directed at persons determined to meet the criteria set forth in § 558.201 of the Regulations, as well as sanctions that may be set forth in any future Executive orders issued pursuant to the national emergency declared in E.O. 13664. The sanctions in E.O. 13664 do not generally prohibit trade or the provision of banking or other financial services to the country of South Sudan. Instead, the sanctions in E.O. 13664 apply where the transaction or service in question involves property or interests in property that are blocked pursuant to these sanctions.

Subpart A of the Regulations clarifies the relation of this part to other laws and regulations. Subpart B of the Regulations implements the prohibitions contained in sections 1, 2, 3, and 5 of E.O. 13664, as well as the prohibitions contained in any further Executive orders issued pursuant to the national emergency declared in E.O. 13664. See, e.g., §§ 558.201 and 558.205. Persons designated by or under the authority of the Secretary of the Treasury pursuant to E.O. 13664, or otherwise blocked pursuant to E.O. 13664, as well as persons who are blocked pursuant to any further Executive orders issued pursuant to the national emergency declared in E.O. 13664, are referred to throughout the Regulations as “persons whose property and interests in property are blocked pursuant to § 558.201.” The names of persons designated or identified as blocked pursuant to E.O. 13664, or any further Executive orders issued pursuant to the national emergency declared therein, are published on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List), which is accessible via OFAC's website. Those names also are published in the Federal Register as they are added to the SDN List.

Sections 558.202 and 558.203 of subpart B detail the effect of transfers of blocked property in violation of the Regulations and set forth the requirement to hold blocked funds, such as currency, bank deposits, or liquidated financial obligations, in interest-bearing blocked accounts. Section 558.204 of subpart B provides that all expenses incident to the maintenance of blocked tangible property shall be the responsibility of the owners and operators of such property, and that such expenses shall not be met from blocked funds, unless otherwise authorized. The section further provides that blocked property may, in OFAC's discretion, be sold or liquidated and the net proceeds placed in a blocked interest-bearing account in the name of the owner of the property.

Section 558.205 of subpart B prohibits any transaction that evades or avoids, has the purpose of evading or avoiding, causes a violation of, or attempts to violate any of the prohibitions set forth in § 558.201 of the Regulations, and any conspiracy formed to violate such prohibitions.

Section 558.206 of subpart B details transactions that are exempt from the prohibitions of the Regulations pursuant to section 203(b) of IEEPA (50 U.S.C. 1702(b)).

In subpart C of the Regulations, new definitions are being added to other key terms used throughout the Regulations. Because these new definitions were inserted in alphabetical order, the definitions that were in the prior abbreviated set of regulations have been renumbered. Similarly, in subpart D, which contains interpretive sections regarding the Regulations, certain provisions have been renumbered and others added to those in the prior abbreviated set of regulations. Section 558.411 of subpart D explains that the property and interests in property of an entity are blocked if the entity is directly or indirectly owned, whether individually or in the aggregate, 50 percent or more by one or more persons whose property and interests in property are blocked, whether or not the entity itself is incorporated into OFAC's SDN List.

Transactions otherwise prohibited by the Regulations but found to be consistent with U.S. policy may be authorized by one of the general licenses contained in subpart E of the Regulations or by a specific license issued pursuant to the procedures described in subpart E of 31 CFR part 501. General licenses and statements of licensing policy relating to this part also may be available through the South Sudan-related sanctions page on OFAC's website: www.treas.gov/ofac.

OFAC is adding a new general license to the Regulations, renumbering existing general licenses, and making technical edits to certain existing general licenses. The new general license, which authorizes U.S. financial institutions to invest and reinvest certain blocked assets, is being added at § 558.506. Existing § 558.506, regarding the provision of legal services, is being renumbered as § 558.507, and existing § 558.507, regarding payments for legal services from funds originating outside the United States, is being renumbered as § 558.508. The authorization for emergency medical services is being renumbered from existing § 558.508 to § 558.509, and OFAC is removing the requirement that the receipt of payment for emergency medical services be specifically licensed. Sections 558.509, 558.510, 558.511, and 558.512, authorizing official business of the U.S. government; official business of certain international organizations and entities; transactions in support of nongovernmental organizations; and transactions related to the provision of agricultural commodities, medicine, medical devices, and other items, respectively, are being renumbered as §§ 588.510, 558.511, 558.512, and 558.513, respectively.

Subpart F of the Regulations refers to subpart C of part 501 for recordkeeping and reporting requirements. Subpart G of the Regulations describes the civil and criminal penalties applicable to violations of the Regulations, as well as the procedures governing the potential imposition of a civil monetary penalty or issuance of a Finding of Violation. Subpart G also refers to appendix A of part 501 for a more complete description of these procedures.

Subpart H of the Regulations refers to subpart E of part 501 for applicable provisions relating to administrative procedures and contains a delegation of certain authorities of the Secretary of the Treasury. Subpart I of the Regulations sets forth a Paperwork Reduction Act notice.

Because the Regulations involve a foreign affairs function, the provisions of E.O. 12866 of September 30, 1993, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.

The collections of information related to the Regulations are contained in 31 CFR part 501 (the “Reporting, Procedures and Penalties Regulations”). Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information have been approved by the Office of Management and Budget under control number 1505-0164. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) because it is impracticable. This is a response to a vessel grounding and immediate action is needed to respond to potential safety hazards associated with vessel salvage operations. It is impracticable to publish an NPRM because we must establish this safety zone by May 15, 2023.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be contrary to public interest because immediate action is needed to ensure the safety of persons, vessels, and the marine environment in the vicinity of Chinese Harbor during vessel salvage operations.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231) and 46 U.S.C. 70011(b)(3). The Captain of the Port (COTP), Los Angeles—Long Beach has determined that potential hazards associated with salvage operations starting May 15, 2023, will be a safety concern for anyone within a 500-yard radius of the operations in Chinese Harbor. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while salvage operations take place in the vicinity of Chinese Harbor.

This rule establishes a safety zone from May 15, 2023, until May 25, 2023. The safety zone will cover all navigable waters from the surface to the sea floor in and around the M/V DANNY C (Official Number 506332) and extending out along a 500-yard radius from the vessel's location while it is in Chinese Harbor. These coordinates are based on North American Datum of 1983. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or his designated representative. Sector Los Angeles—Long Beach may be contacted on VHF-FM Channel 16 or (310) 521-3801. The marine public will be notified of the safety zone via Broadcast Notice to Mariners.

If the COTP determines that the zone need not be enforced during this entire period, the Coast Guard will announce via Broadcast Notice to Mariners when the zone will no longer be subject to enforcement.

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

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

This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. Vessel traffic will be able to safely transit around this safety zone, which will impact a small, designated area of Chinese Harbor, Santa Cruz Island, CA. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 regarding the safety zone and the rule allows vessels to seek permission to enter the zone.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01, Rev. 1, associated implementing instructions, and COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone encompassing an area extending 500-yards out from a vessel engaged in salvage operations in vicinity of Chinese Harbor and will last only 10 days while salvage operations are ongoing. It is categorically excluded from further review under paragraph L60(c), in Appendix A, Table 1 of DHS Instruction Manual 023-001-01, Rev. 1.

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

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

This rule updates National Park Service (NPS) regulations at 36 CFR 7.96(g)(3) to reflect the new address of the Division of Permits Management for the National Mall and Memorial Parks. This change is needed to provide accurate information about where permits for demonstrations and special events within the National Capital Region may be obtained by the public. The Division of Permits Management relocated on February 27, 2023. The NPS has already notified the public of the address change on its website and through other means of communication.

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

Executive Order 13563 reaffirms the principles of Executive Order 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. Executive Order 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. The NPS has developed this rule in a manner consistent with these requirements.

The Regulatory Flexibility Act, 5 U.S.C. 601 et seq., generally requires Federal agencies to prepare a regulatory flexibility analysis for rules that are subject to the notice-and-comment rulemaking requirements under the Administrative Procedure Act (APA) if the rule would have a significant economic impact on a substantial number of small entities. See 5 U.S.C. 601-612. The NPS certifies that this final rule will not have a significant economic effect on a substantial number of small entities. This is a technical, non-substantive rule that updates the street address in Washington, DC, where the public may obtain permit applications for activities within the National Capital Region.

This rule is not a major rule under 5 U.S.C. 804(2). This rule:

(a) Does not have an annual effect on the economy of $100 million or more.

(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

(c) 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.

This rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule will not have a significant or unique effect on State, local, or tribal governments or the private sector. It addresses public use of national park lands and imposes no requirements on other agencies or governments. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq. ) is not required.

This rule will not effect a taking of private property or otherwise have takings implications under Executive Order 12630. A takings implication assessment is not required.

Under the criteria in section 1 of Executive Order 13132, the rule will not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. A federalism summary impact statement is not required.

This rule complies with the requirements of Executive Order 12988. This rule:

(a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and

(b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.

The Department of the Interior strives to strengthen its government-to-government relationship with Indian Tribes through a commitment to consultation with Indian tribes and recognition of their right to self-governance and tribal sovereignty. The NPS has evaluated this rule under the criteria in Executive Order 13175 and under the Department's tribal consultation policy and has determined that tribal consultation is not required because the rule will have no substantial direct effect on federally recognized Indian tribes.

This rule does not contain information collection requirements, and a submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) is not required. The NPS 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.

This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the National Environmental Policy Act of 1969 (NEPA) is not required because this is a technical regulation. (For further information see 43 CFR 46.210(i).) 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.

This rulemaking is not a significant energy action under the definition in Executive Order 13211; the rule is not likely to have a significant adverse effect on the supply, distribution, or use of energy, and the rule has not otherwise been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. A Statement of Energy Effects is not required.

The NPS recognizes that under 5 U.S.C. 553(b) and (c), notice of proposed rules ordinarily must be published in the Federal Register and the agency must give interested parties an opportunity to submit their views and comments. The NPS has determined under 5 U.S.C. 553(b) and 318 DM HB 5.3, however, that notice and public comment for this rule are not required. We find good cause to treat notice and comment as unnecessary because this rule simply updates the address of the Division of Permits Management that appears in NPS regulations to reflect the current address of the Division.

In consideration of the foregoing, the National Park Service amends 36 CFR part 7 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:

You may access a frequently updated electronic version of 40 CFR part 180 through the Federal Register Office'se-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-2021-0612, 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 July 17, 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-2021-0612, 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 June 22, 2022 (87 FR 37287) (FRL-9410-02-OCSPP), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11613) by Spring Regulatory Sciences, on behalf of Lamberti-USA, Inc. (Lamberti), 161 Washington Street, Conshohocken, PA 19428. The petition requested that 40 CFR 180.910 be amended by establishing exemptions from the requirement of a tolerance for residues of D-glucopyranose, oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium salts (CAS Reg. No. 2585031-35-0); D-glucopyranose, oligomeric, maleates, C10-16-alkyl glycosides, sulfonated, potassium salts (CAS Reg. No. 2587364-77-8); and D-glucopyranose, oligomeric, maleates, C9-11-branched and linear alkyl glycosides, sulfonated, potassium salts (CAS Reg. No, 1228577-37-4) when used as inert ingredients (surfactants) in pesticide formulations pre- and post-harvest. That document referenced a summary of the petition prepared by Lamberti, which is available in the docket at 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 from 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 or exemption 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 these actions. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for D-glucopyranose, oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium salts; D-glucopyranose, oligomeric, maleates, C10-16-alkyl glycosides, sulfonated, potassium salts; and D-glucopyranose, oligomeric, maleates, C9-11-branched and linear alkyl glycosides, sulfonated, potassium salts, including exposure resulting from the exemptions established by this action. These three chemicals are potassium salts of alkyl (C8-C20) polyglucoside esters (AGEs) and are herein referred to as the AGE potassium salts. EPA's assessment of exposures and risks associated with the AGE potassium salts 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 the AGE potassium salts 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.

The toxicological database of the AGE potassium salts is supported by data used for the Agency's 2015 evaluation of two AGE sodium salts and one AGE lactate (80 FR 31481, June 3, 2015). When EPA previously reviewed those AGEs, limited data were available, and the Agency determined that it would be appropriate to bridge to data for similar chemicals. EPA has determined that a similar approach is appropriate for the three AGE potassium salts because of the similarities in the manufacturing processes, functional groups/structure, composition, physical/chemical properties, and expected toxicity of these chemicals to those previously reviewed.

The AGEs are reaction products of glucose and fatty acids in which the alcohol moiety is attached to the polyglucoside by a β-glucosides linkage. Alkyl polyglucoside is the first degradation product in the biodegradation pathway of the AGEs, and toxicity data for alkyl polyglucoside are very similar for the different alcohol chain lengths in the range C8-C20. The toxicity profile of the AGE potassium salts is therefore based upon data considered in the previous risk assessment for AGE sodium salts and AGE lactate where the alcohol component of the AGE substances is in the same C8-C20 range and is considered appropriate for read across purposes.

Specifically, EPA considered data for D-glucopyranose, oligomeric, 6-(dihydrogen 2-hydroxy-1,2,3-propanetricarboxylate), 1-(coco alky) ethers, sodium salts (CAS No. 151911-51-2); D-glucopyranose, oligomeric, 6-(hydrogen 2-sulfobutanedioate), 1-(coco alkyl) ethers, sodium salts (CAS No. 151911-53-4); D-glucopyranose, oligomeric, 6-[hydrogen (2R, 3R)-2,3-dihydroxybutanedioate], 1-(coco alkyl) ethers, sodium salts (CAS No. 151911-52-3); and D-Glucopyranose, oligomeric, maleates, C9-11-branched and linear alkyl glycosides, sulfonated, sodium salts (CAS No. 1228577-41-0), as well as the metabolites disodium sulfosuccinate and other sulfosuccinates.

In acute studies, the oral lethal dose, LD 50 for the AGEs was >5,000 milligrams/kilogram (mg/kg). There is no available data regarding acute exposure via the dermal, eye or inhalation routes. Repeat dose studies were conducted with alkyl polyglucosides and organic acids (metabolites) in which no toxicity was seen at doses as high as 1,000 mg/kg/day. No fetal, parental, or reproductive toxicity was seen in a reproduction/developmental toxicity screening test up to 1,000 mg/kg/day. In addition, no evidence of neurotoxicity was seen in the database. Ames studies conducted with various AGE sodium salts were negative for mutagenicity, and there was no indication of carcinogenicity when the Agency evaluated the carcinogenic potential of AGEs by conducting a qualitative structure activity relationship (SAR) using the database, DEREK Nexus Version 2.0. No structural alerts were identified for carcinogenicity.

Specific information on the studies reviewed and the nature of the adverse effects caused by the AGEs can be found at https://www.regulations.gov in the documents “IN-11613; Alkyl (C8-C20) polyglucoside esters (AGEs) potassium salts. Human Health Risk Assessment and Ecological Effects Assessment to Support Inert Ingredient Approval for use in Pesticide Formulations” in docket ID number EPA-HQ-OPP-2021-0612, and “PC Codes 911028, 911029, 911030: Alkyl (C8-C20) polyglucoside Esters (AGEs); Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations” in docket ID number EPA-HQ-OPP-2014-0678.

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.

The hazard profile of the AGE potassium salts is adequately defined. These salts are rapidly hydrolyzed in intestine and liver. The cleavage products, sugars, and long-chain alcohols enter the pathways of lipid and carbohydrate metabolism. Based on the low acute, subchronic, and developmental toxicity of AGEs, the body's ability to rapidly metabolize these substances, the expected metabolites being fatty acids and carbohydrates (which are normal constituents of the body), and the lack of observed adverse effects for repeat dose studies at the limit dose (1,000 mg/kg/day), no toxicological endpoint of concern or PODs were identified. Therefore, a qualitative risk assessment for the AGE potassium salts can be performed.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to the AGE potassium salts, EPA considered exposure under the proposed exemptions from the requirement of a tolerance. There are no other known food uses for these chemicals; therefore, EPA assessed the proposed dietary exposures from the AGE potassium salts in food as follows:

Dietary exposure (food and drinking water) to the AGE potassium salts may occur following ingestion of foods with residues from their use in accordance with these exemptions. However, a quantitative dietary exposure assessment was not conducted since a toxicological endpoint for risk assessment was not identified.

2. 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). AGE potassium salts may be present in pesticide and non-pesticide products that may be used in and around the home, including personal care products such as antiperspirants, shampoos, conditioners, and moisturizers. However, a quantitative residential exposure assessment was not conducted since a toxicological endpoint for risk assessment was not identified.

3. 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.”

Based on the lack of toxicity in the available database, EPA has not found the AGE potassium salts to share a common mechanism of toxicity with any other substances, and the AGE potassium salts do not appear to produce a toxic metabolite produced by other substances. For the purposes of these tolerance exemptions, therefore, EPA has assumed that AGE potassium salts do 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.

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.

Based on an assessment of surrogate data for the AGE potassium salts, EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children. Because there are no threshold effects associated with the AGE potassium salts, EPA conducted a qualitative assessment. As part of that assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children.

Because no toxicological endpoints of concern were identified, 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 the AGE potassium salt residues.

An analytical method is not required for enforcement purposes since the Agency is establishing exemptions from the requirement of a tolerance without any numerical limitation.

Therefore, exemptions from the requirement of a tolerance are established for residues of D-glucopyranose, oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium salts (CAS Reg. No. 2585031-35-0); D-glucopyranose, oligomeric, maleates, C10-16-alkyl glycosides, sulfonated, potassium salts (CAS Reg. No. 2587364-77-8); and D-glucopyranose, oligomeric, maleates, C9-11-branched and linear alkyl glycosides, sulfonated, potassium salts (CAS Reg. No. 1228577-37-4) when used as inert ingredients (surfactants) in pesticide formulations applied pre- and post-harvest under 40 CFR 180.910.

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

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemptions 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 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-2022-0942 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 July 17, 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-2022-0942, 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 January 3, 2023 (88 FR 38) FRL-9410-08), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11624) by Veto-Pharma SAS, 12-14 Rue de la Croix-Martre, 91120 Palaiseau, France. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of erucamide (CAS Reg. No. 112-84-5) when used as an inert ingredient (lubricant) in pesticide formulations when applied on the raw agricultural commodities honey and honeycomb. That document referenced a summary of the petition prepared by Veto-Pharma SAS, 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 from the requirement of a tolerance, FFDCA section 408(c)(2)(B) directs EPA to take into account the considerations set forth 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 erucamide, including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with erucamide 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 erucamide 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.

The available toxicity studies indicate that erucamide has low overall toxicity. Erucamide has low acute toxicity via the oral, dermal, and inhalation routes, is not an eye or skin irritant, and is not a skin sensitizer. No adverse effects were reported in the 90-day oral toxicity study in rats. This study also performed neurobehavioral screening, and no signs of neurotoxicity were reported. No adverse maternal or developmental effects were found in the developmental toxicity study in rats. Also, no effects were observed in the reproduction parameters assessed in the available 90-day study in rats, and predictive toxicology ( i.e., computer modeling) indicates that there is no known precedent for reproductive toxic potential for erucamide. Furthermore, concern for carcinogenicity is low, based on negative results in mutagenicity and genotoxicity studies, and the lack of structural alerts for carcinogenicity.

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.

The hazard profile of erucamide is adequately defined. Overall, erucamide is of low acute, subchronic, and developmental toxicity. No systemic toxicity is observed up to 1,000 mg/kg/day. Since signs of toxicity were not observed, no toxicological endpoints of concern or PODs were identified. Therefore, a qualitative risk assessment for erucamide was performed.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to erucamide, EPA considered exposure under the proposed exemption from the requirement of a tolerance and existing uses. EPA assessed dietary exposures from erucamide in food as follows:

Dietary exposure to erucamide may occur from eating foods treated with pesticide formulations containing this inert ingredient and drinking water containing runoff from soils containing the treated crops. Dietary exposure may also occur from non-pesticidal uses ( e.g., FDA-approved uses in food contact surfaces). However, a quantitative dietary exposure assessment was not conducted since a toxicological endpoint for risk assessment was not identified.

2. 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).

Erucamide may be present in pesticide and non-pesticide products that may be used in and around the home. However, a quantitative residential exposure assessment was not conducted since a toxicological endpoint for risk assessment was not identified.

3. 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.”

Based on the lack of toxicity in the available database, EPA has not found erucamide to share a common mechanism of toxicity with any other substances, and erucamide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance exemption, therefore, EPA has assumed that erucamide 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.

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.

Based on an assessment of erucamide, EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children. Because there are no threshold effects associated with erucamide, EPA conducted a qualitative assessment. As part of that assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children.

Because no toxicological endpoints of concern were identified, 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 erucamide residues.

Analytical Enforcement Methodology

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

Therefore, an exemption from the requirement of a tolerance is established for residues of erucamide (CAS Reg. No. 112-84-5) when used as an inert ingredient (lubricant) in pesticide formulations when applied on the raw agricultural commodities honey and honeycomb under 40 CFR 180.910.

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 exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

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

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

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

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

We received an application from the Navy requesting 5-year regulations and authorization to take multiple species of marine mammals. This rule establishes a framework under the authority of the Marine Mammal Protection Act (MMPA) (16 U.S.C. 1361 et seq. ) to allow for the authorization of take by Level A and Level B harassment of marine mammals incidental to the Navy's construction activities related to the replacement of Pier 3 at Naval Station Norfolk in Norfolk, Virginia. Please see Background below for definitions of harassment.

Section 101(a)(5)(A) of the MMPA (16 U.S.C. 1371(a)(5)(A)) directs the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region for up to 5 years if, after notice and public comment, the agency makes certain findings and issues regulations that set forth permissible methods of taking pursuant to that activity and other means of effecting the “least practicable adverse impact” on the affected species or stocks and their habitat (see the discussion below in the Mitigation section), as well as monitoring and reporting requirements. Section 101(a)(5)(A) of the MMPA and the implementing regulations at 50 CFR part 216, subpart I provide the legal basis for issuing this rule containing 5-year regulations, and for any subsequent LOAs. As directed by this legal authority, this rule contains mitigation, monitoring, and reporting requirements.

Following is a summary of the major provisions of this rule regarding Navy construction activities. These measures include:

• Required monitoring of the construction areas to detect the presence of marine mammals before beginning construction activities;

• Shutdown of construction activities under certain circumstances to avoid injury of marine mammals; and

• Soft start for impact pile driving to allow marine mammals the opportunity to leave the area prior to beginning impact pile driving at full power.

The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq. ) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are proposed or, if the taking is limited to harassment, a notice of a proposed IHA is provided to the public for review.

Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the mitigation, monitoring and reporting of the takings are set forth. The definitions of all applicable MMPA statutory terms cited above are included in the relevant sections below.

On April 8, 2022, NMFS received a request from the Navy for authorization to take marine mammals incidental to construction activities related to the replacement of Pier 3 at Naval Station Norfolk in Norfolk, Virginia. Following NMFS' review of the application, the Navy provided responses to questions on June 3, 2022, and August 29, 2022. A revised version of the application was submitted on September 22, 2022. The application was deemed adequate and complete on September 26, 2022, and published in the Federal Register for public review and comment on October 7, 2022 (87 FR 60998). We did not receive substantive comments on the notice of receipt (NOR).

On March 9, 2023, NMFS published a notice of proposed rulemaking in the Federal Register (88 FR 14560). The regulations are valid for 5 years (2023-2028) from the date of issuance, and authorize the Navy to take five species of marine mammals by Level B harassment and, for a subset of these species, Level A harassment incidental to construction activities related to the replacement of Pier 3 at Naval Station Norfolk, Norfolk, Virginia. Neither the Navy nor NMFS expect serious injury or mortality to marine mammals to result from this activity, and none has been authorized.

NMFS previously issued an Incidental Harassment Authorization (IHA) (87 FR 15945, March 21, 2022) to the Navy for authorization to take marine mammals during the first year of the construction project described in this rule. Upon request from the Navy, NMFS modified the 2022 IHA (88 FR 2880, January 18, 2023) to include concurrent pile driving and drilling activities due to a change in the contractor's construction plan that was not initially analyzed in the initial activity. This rule could not be completed prior to expiration of the Navy's modified 2022 IHA and, therefore, the Navy requested issuance of a renewal IHA associated with continued work towards completion of year 1 of the construction project. The requested renewal IHA was issued on March 30, 2023 (88 FR 20133, April 5, 2023). As required, the Navy provided monitoring reports (available at: https://www.fisheries.noaa.gov/action/incidental-take-authorization-replacement-pier-3-naval-station-norfolk-norfolk-virginia ) that confirm that it has implemented the required mitigation and monitoring, and also show that no impacts of a scale or nature not previously analyzed or authorized have occurred as a result of the activities conducted. No changes were made from the proposed to the final rule.

The Navy is currently conducting, and will continue, the replacement of Pier 3 at NAVSTA Norfolk, in Norfolk, VA. The aforementioned 2022 IHA (as modified) and subsequent renewal covered the first year of project activities, and this rule covers the remaining activities for the pier replacement. During this period demolition and construction activities will occur at existing Pier 3, new Pier 3, CEP-176 wharf, CEP-102 relieving platform, and on a fender system of CEP-175 bulkhead (See Figure 1). Activities under the rule include both vibratory pile driving and removal, impact pile driving, and pre-drilling (hereafter, referred to as “drilling”). Sounds resulting from pile driving, drilling, and removal may result in the incidental take of marine mammals by Level A and Level B harassment in the form of auditory injury or behavioral harassment.

The regulations are valid for a period of 5 years (2023-2028). The specified activities may occur at any time during the 5-year period of validity of the regulations. The Navy expects pile driving and drilling for the entire project to occur on approximately 513 non-consecutive days over a 4-year duration, with the greatest amount of work occurring during Year 4 (approximately 204 days). However, in the event of unforeseen delays, the project may occur over the full 5-year duration of this rule. The Navy plans to conduct all work during daylight hours.

Pier 3 at NAVSTA Norfolk is located at the confluence of the Elizabeth River, James River, Nansemond River, LaFeyette River, Willoughby Bay, and Chesapeake Bay (Figure 2).

Anthropogenic sound is a significant contributor to the ambient acoustic environment surrounding NAVSTA Norfolk, as it is located in close proximity to shipping channels as well as several Port of Virginia facilities with frequent vessel traffic that altogether have an annual average of 1,788 vessel calls (Port of Virginia, 2021). Other sources of human-generated underwater sound not specific to naval installations include sounds from echosounders on commercial and recreational vessels, industrial ship noise, and noise from recreational boat engines. Additionally, on average, maintenance dredging of the navigation channel occurs every 2 years (USACE and Port of Virginia, 2018).

The project involves the replacement of Pier 3 at NAVSTA waterfront. The existing Pier 3 will be completely demolished and a new Pier 3 will be constructed immediately north of the existing location (Figure 2). The project scope for the replacement of Pier 3 under this rule will also include construction of new CEP-176 wharf, construction of new CEP-102 relieving platform, and construction of a portion of fender system at CEP-175. The project includes six phases, the first of which has begun under the previously issued IHA (87 FR 15945, March 21, 2022). A preliminary work schedule and activity details for the work under this rule are provided in Table 1. In-water construction activities, including pile driving, pile removal, and drilling are described in detail below:

Pile Removal— Piles are anticipated to be removed with a vibratory hammer, however, direct pull or clamshell removal may be used depending on site conditions. All three pile removal methods are described below. Take is not expected to occur for clamshell and direct pull removal, therefore they will not be described past what is provided below nor included in our analysis:

• Vibratory Extraction—This method uses a barge-mounted crane with a vibratory driver to remove all pile types. The vibratory driver is a large mechanical device (5 to 16 tons (4.5 to 14.5 metric tons)) suspended from a crane by a cable and positioned on top of a pile. The pile is then loosened from the sediments by activating the driver and slowly lifting up on the driver with the aid of the crane. Once the pile is released from the sediments, the crane continues to raise the driver and pull the pile from the sediment. The driver is typically shut off once the pile is loosened from the sediments. The pile is then pulled from the water and placed on a barge. Vibratory extraction usually takes between less than 1 minute (for timber piles) to 30 minutes per pile depending on the pile size, type, and substrate conditions;

• Clamshell—In cases where use of a vibratory driver is not possible ( e.g., when the pile may break apart from clamp force and vibration), a clamshell apparatus may be lowered from the crane in order to remove pile stubs. The use and size of the clamshell bucket would be minimized to reduce the potential for generating turbidity during removal; and

• Direct Pull—Piles may be removed by wrapping the piles with a cable or chain and pulling them directly from the sediment with a crane. In some cases, depending on access and location, piles may be cut at or below the mudline.

Pile Installation —Pile installation/removal would occur using land-based or barge-mounted cranes, as appropriate. Concrete piles would be installed using an impact hammer. Steel piles and polymeric piles can be installed using an impact hammer or vibratory hammer. Hammers can be steam, air, or diesel drop, single-acting, double-acting, differential-acting, or hydraulic type. Additionally, pre-drilling may occur for installation of concrete piles and at locations where there may be a higher likelihood of obstructions or where soil layers are harder to penetrate. Drilling is not permitted for installation of steel piles on this project or for concrete piles at Pier 3 because hard soil layers are not expected at these locations.

Table 1 provides the estimated construction schedule and production rates for the construction activities considered for this rulemaking beginning with Year 2. As indicated above, Year 1 of the Pier 3 replacement project was authorized under the 2022 IHA and subsequent renewal. Therefore, Year 2 of the project aligns with year 1 of the rule. Some project elements will use only one method of pile installation ( e.g., impact hammer or vibratory hammer or impact hammer and drilling), but all methods have been analyzed. The method of installation will be determined by the construction crew once demolition and installation has begun.

Concurrent Activities —In order to maintain project schedules, it is likely that multiple pieces of equipment would operate at the same time within the project area. Table 2 provides a summary of the possible equipment combinations by structure and construction year where a maximum of four in-water activities may be occurring simultaneously. As mentioned above, the method of installation, and whether concurrent pile driving scenarios will be implemented, will be determined by the construction crew once the project has begun. Therefore, the total take estimate reflects the worst case scenario for the project.

Mitigation, monitoring, and reporting measures are described in detail later in this document (please see Mitigation and Monitoring and Reporting).

NMFS' notice of proposed rulemaking was published in the Federal Register on March 9, 2023 (88 FR 14560). That proposed rule described, in detail, the Navy's activities, the marine mammal species that may be affected by the activities, and the anticipated effects on marine mammals. In that proposed rule, we requested public input on the request for authorization described therein, our analyses, the proposed authorization, and any other aspect of the notice of proposed rulemaking, and requested that interested persons submit relevant information, suggestions, and comments. The proposed rule was available for a 30-day public comment period.

During the 30-day public comment period, NMFS received one substantive comment submission, from a member of the public. NMFS' responses to the comments in the submission are provided below, and all comments are available online at: https://www.regulations.gov/document/NOAA-NMFS-2022-0110-0001/comment.

Comment 1: A member of the public noted that the Navy's construction work has the potential to cause sediment runoff into the marine environment, which can smother marine plants and reduce light availability for primary productivity. The individual indicated agreement with the mitigation measures as outlined in the notice of proposed rulemaking and recommends that extra vegetation be planted and heavy monitoring of substrates occur throughout the project. The individual also noted concerns with the impact of underwater noise on the life history of marine fish species as well as sea turtles.

Response: NMFS appreciates the commenter's engagement in the rulemaking process, but notes that concerns regarding sediment runoff are outside NMFS' purview under the MMPA, except inasmuch as such impacts may affect marine mammal habitat (including prey). Similarly, concerns related to species other than marine mammals (and marine mammal habitat), such as sea turtles, are outside NMFS' purview under the MMPA. As required under the MMPA, NMFS assessed the impacts of the Navy's construction project on marine mammals and their habitat and made the necessary findings in support of issuance of this rule and subsequent LOA. NMFS notes that mitigation and monitoring prescribed will affect the least practicable adverse impact on marine mammals and their habitat.

As described in the proposed rule (88 FR 14560, March 9, 2023), NMFS finds that the most likely impact to fish ( i.e., potential prey) from pile driving activities at the project areas would be temporary behavioral avoidance of the area. The duration of fish avoidance of this area after pile driving stops is unknown, but a rapid return to normal recruitment, distribution and behavior is anticipated. Any behavioral avoidance by fish of the disturbed area would still leave significantly large areas of fish and marine mammal foraging habitat in the nearby vicinity.

Construction activities, in the form of increased turbidity, have the potential to adversely affect forage fish in the project area. Forage fish form a significant prey base for many marine mammal species that occur in the project area. Increased turbidity is expected to occur in the immediate vicinity of construction activities. However, suspended sediments and particulates are expected to dissipate quickly within a single tidal cycle. Given the limited area affected, any effects on forage fish are expected to be minor or negligible.

Comment 2: The commenter indicated concern regarding the length of time for which the rule is valid, noting five years is a significant amount of time and believes the regulations should be valid for a shorter period of time so NMFS is able to reevaluate the success of the mitigation and monitoring plan.

Response: MMPA section 101(a)(5)(A) allows the authorization of incidental taking of marine mammals by U.S. citizens incidental to specified activities for up to 5 consecutive years, as requested by the Navy in this case. Therefore, NMFS has determined that 5 years is an appropriate length of time for effectiveness of the rule. Additionally, the regulations governing the take of marine mammals incidental to Navy construction activities contains an adaptive management component. Please see the Adaptive Management section for more detail.

Comment 3: The individual recommends that trained professionals report on any harm to marine life, the use of visual and acoustic monitoring techniques, and measures to limit noise pollution in the marine environment.

Response: NMFS concurs with the recommendation to use trained professional protected species observers (PSOs), which were included in the proposed rule as well as this final rule. These PSOs will provide adequate visual monitoring to ensure the Navy complies with the requirements outlined in their issued LOA. The Navy will also collect acoustic data for specified piles as outlined in their Marine Mammal Monitoring Plan. Additionally, the Navy will submit a visual and acoustic monitoring report to NMFS annually, well as a comprehensive report at the conclusion of the five years. Please see the Mitigation and Monitoring and Reporting sections of this final rule for additional details.

Sections 3 and 4 of the application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history of the potentially affected species. NMFS fully considered all of this information, and we refer the reader to these descriptions, incorporated here by reference, instead of reprinting the information. Additional information regarding population trends and threats may be found in NMFS' Stock Assessment Reports (SARs; www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments ) and more general information about these species ( e.g., physical and behavioral descriptions) may be found on NMFS' website ( https://www.fisheries.noaa.gov/find-species ).

Table 3 lists all species or stocks for which take is expected and is authorized for this activity, and summarizes information related to the population or stock, including regulatory status under the MMPA and Endangered Species Act (ESA) and potential biological removal (PBR), where known. PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS' SARs). While no serious injury or mortality is expected to occur, PBR and annual serious injury and mortality from anthropogenic sources are included here as gross indicators of the status of the species or stocks and other threats.

Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS' stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All stocks managed under the MMPA in this region are assessed in NMFS' U.S. Atlantic and Gulf of Mexico SARs. All values presented in Table 2 are the most recent available at the time of publication, including from the draft 2022 SARs, and are available online at: www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments.