This action, pursuant to 5 U.S.C. 551 et seq., amends regulations, at 7 CFR part 800 and part 810, issued under the United States Grain Standards Act (7 U.S.C. 71-87k), as amended (USGSA). Section 4 of the USGSA (7 U.S.C. 76(a)) grants the Secretary of Agriculture the authority to establish standards for grain regarding kind, class, quality, and condition.

In response to requests from grain industry representatives, AMS published a proposed rule in the Federal Register on March 31, 2023 (88 FR 19229), inviting interested parties to comment on the proposed removal of SBOC as an official factor for soybeans.

AMS regularly reviews grain standards to ensure their effectiveness in meeting the quality requirements of grain moving in the value chain. An increase in the amount of SBOC in officially graded soybean lots over the past two years has led to a decrease in the marketability of U.S. soybeans versus those from other exporting countries. In the proposed rule, AMS invited stakeholders to comment on the effect of removing SBOC as an official grade-determining factor.

Additionally, the proposed rule addressed making the standards effective on an expediated timeline. According to the USGSA, “No standards established or amendments or revocations of standards under this chapter shall become effective less than one calendar year after promulgation thereof, unless in the judgment of the Secretary, the public health, interest, or safety require that they become effective sooner” (7 U.S.C. 76(b)(1)). In the proposed rule, AMS argued that effecting the standards change in a shorter timeframe is in the public's interest and invited comments to determine if this is the case.

AMS received 14 comments in response to the proposed rule. All 14 comments were in favor of the proposed changes. The comments received were submitted by individuals, small businesses, trade organizations, and producer advocacy groups. Two commenters were national and state organizations representing soybean growers. Another comment was submitted by a large grain trade organization and was cosigned by 43 organizations that represent grain handling, storage, export, processing, as well as seed and feed sectors. The remainder of comments were from individuals representing small producers and trade businesses.

Many comments expressed favor toward the proposed rule, noting that there is no significant difference in end-use quality between soybeans with differing levels of SBOC. Nine of the comments included this information, in some form or another. Of these, four specifically cited the study that AMS conducted, based on the recommendation of the Grain Inspection Advisory Committee. 1

Five of the comments noted that the inclusion of SBOC, as a grade factor, causes U.S. soybeans to be less competitive in the world export market. Two of these comments also noted that other major soybean producing countries do not use a factor like SBOC to determine soybean quality.

Some comments referenced the negative impact that higher levels of SBOC had on growers and handlers of soybeans. Five commenters mentioned that SBOC, as a grade determining factor, has led to reduced income for growers who failed to meet the standard for U.S. No. 2 Yellow Soybeans on SBOC alone. Two comments noted that higher SBOC levels has led to increased operational cost, such as having to pay for extra inspections or trucking soybeans longer distances to find buyers.

Commenters also asserted that keeping SBOC, as a grading criterion, would be contrary to the stated objectives of the USGSA, which states that the grading standards shall “offer users of such standards the best possible information from which to determine end-product yield and quality of grain” and “reflect the economic value-based characteristics in the end uses of grain” (7 U.S.C. 74(b)(3)).

AMS agrees with the commentors. The comment process is designed to give interested parties an opportunity to present data, views, and arguments. The needs of the trade in soybeans requires this change for U.S. soybeans to be competitive in the export market, and the available data shows that SBOC does not affect soybean quality. Therefore, AMS is amending the standards for soybeans.

AMS invited interested parties to comment on whether the proposed changes should go into effect by September 1, 2023. The Agency sought such comments because the USGSA requires that changes to the grain standards may not be made effective within one calendar year of their promulgation “unless in the judgment of the Secretary, the public health, interest, or safety require that they become effective sooner” (7 U.S.C. 76(b)(1)). This provision was put into place to allow industry participants adequate time to adjust and transition to new standards. However, in this case, the soybeans that are more likely to exhibit discolored seedcoats and trigger higher determinations of SBOC in soybean samples are already present in the supply chain. Additionally, based on AMS research showing that the color variation does not materially affect the end use of the soybeans, the Agency did not foresee any deleterious effects to farmers or merchandisers by making the rule effective sooner.

As a result of the request for comments regarding the implementation period, AMS received a comment from a national producer organization that strongly urged the Agency to implement the rule in advance of the 2023-2024 soybean marketing year, which begins on September 1, 2023. All other comments were in support of implementing the proposed rule, as published.

In light of the comment urging AMS to adopt the new standard quickly, the standard “shall become effective less than one calendar year after promulgation thereof” because “the public health, interest, or safety require that [this standard] become effective sooner [than one year.]” (7 U.S.C. 76(b)(1)). The current standard is unnecessarily increasing costs to the public and farmers, and unnecessarily foreclosing markets for otherwise commercially indistinguishable soybeans. Therefore, AMS will maintain September 1, 2023, as the effective date for implementing the changes contained in this final rule.

AMS is revising 7 CFR part 810, Subpart J, United States Standards for Soybeans to eliminate SBOC as an official factor but retain it in the standards as part of the definition of the class Yellow soybeans. AMS is also revising 7 CFR 800.86 Inspection of shiplot, unit train, and lash barge grain in single lots, paragraph (c)(2), by removing SBOC from Table 17.

For reasons set forth in the preamble, the Agricultural Marketing Service amends 7 CFR parts 800 and 810 as follows:

I. Statutory and Regulatory Background

For monetary policy purposes, section 19 of the Federal Reserve Act (“Act”) requires the Board to impose reserve requirements on certain types of deposits and other liabilities of depository institutions within ratios specified by the Act. 1 The Board's Regulation D implements section 19 of the Act. 2

Three of the definitions in Regulation D—footnote 3 to the definition of “time deposit,” footnote 6 to the definition of “nonpersonal time deposit,” and footnote 11 to the definition of “international banking facility time deposit or IBF time deposit”—refer to liabilities maintained by depository institutions for “[a]ny other foreign, international, or supranational entity specifically designated by the Board.”  3 The foreign, international, or supranational entities specifically designated by the Board for these purposes are set forth at 12 CFR 204.125 of Regulation D as an interpretation of the regulation. 4 This interpretation was originally promulgated as § 217.126 of former Regulation Q (Prohibition Against Payment of Interest on Demand Deposits). 5 The interpretation was deleted from Regulation Q and redesignated as § 204.125 of Regulation D in 1987. 6 However, while the references to the interpretation in footnotes 3 and 11 of Regulation D were updated to refer to § 204.125 instead of § 217.126, the reference in footnote 6 (formerly footnote 8) of Regulation D was not and continues to refer to § 217.126 instead of referring to § 204.125. 7 Accordingly, footnote 6 of Regulation D is amended to refer to § 204.125 instead of § 217.126 in order to conform the provision to Regulation D amendments finalized in 1987.

In addition, the heading and the introductory text of the interpretation set forth at 12 CFR 204.125 require two amendments to conform the interpretation to prior regulatory amendments. In 12 CFR 204.125, the heading currently reads “§ 204.125 Foreign, international, and supranational entities referred to in §§ 204.2(c)(1)(iv)(E) and 204.8(a)(2)(i)(B)(5)” and the introductory text reads “The entities referred to in §§ 204.2(c)(1)(iv)(E) and 204.8(a)(2)(i)(B)(5) are:”.

First, the references to § 204.2(c)(1)(iv)(E) in the heading and the introductory text are amended to refer to § 204.2(c)(1)(iii)(E) in order to conform the heading and the introductory text to Regulation D amendments finalized in 2020. 8 Second, the heading and the introductory text are amended to add a reference to the definition of “nonpersonal time deposit,” 12 CFR 204.2(f)(1)(iv)(E), to conform the heading and the introductory text to Regulation D amendments finalized in 1991. 9

In general, the Administrative Procedure Act (“APA”)  10 imposes three principal requirements when an agency promulgates legislative rules (rules made pursuant to congressionally-delegated authority): (1) publication with adequate notice of a proposed rule; (2) followed by a meaningful opportunity for the public to comment on the rule's content; and (3) publication of the final rule not less than 30 days before its effective date. The APA provides that notice and comment procedures do not apply if the agency for good cause finds them to be “unnecessary, impracticable, or contrary to the public interest.”  11 Section 553(d) of the APA also provides that publication at least 30 days prior to a rule's effective date is not required for (1) a substantive rule which grants or recognizes an exemption or relieves a restriction; (2) interpretive rules and statements of policy; or (3) a rule for which the agency finds good cause for shortened notice and publishes its reasoning with the rule. 12

The Board has determined that good cause exists for finding that the notice, public comment, and delayed effective date provisions of the APA are unnecessary, impracticable, or contrary to the public interest with respect to these final amendments to Regulation D. The amendments are technical in nature and do not change any of the substantive provisions of the rule. Notice, public comment, and a delayed effective date under these circumstances would not serve any useful purpose. Accordingly, the Board has determined that good cause exists to dispense with the notice, public comment, and delayed effective date procedures of the APA with respect to these final amendments to Regulation D.

The Regulatory Flexibility Act (“RFA”) does not apply to a rulemaking where a general notice of proposed rulemaking is not required. 13 As noted previously, the Board has determined that it is unnecessary and contrary to the public interest to publish a general notice of proposed rulemaking for this final rule. Accordingly, the RFA's requirements relating to an initial and final regulatory flexibility analysis do not apply.

In accordance with the Paperwork Reduction Act (“PRA”) of 1995, 14 the Board reviewed the final rule under the authority delegated to the Board by the Office of Management and Budget. The final rule contains no requirements subject to the PRA.

For the reasons set forth in the preamble, the Board amends 12 CFR part 204 as follows:

Authority for This Rulemaking

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

The FAA published a notice of proposed rulemaking for Docket No. FAA-2023-0721 in the Federal Register (88 FR 17437; March 23, 2023), proposing to revoke Jet Route J-184 and establish RNAV route Q-180 due to service limitations associated with signal coverage issues of the Deming, NM, Very High Frequency (VHF) Omni-Directional Range/Tactical Air Navigation (VORTAC) navigational aid (NAVAID). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received.

Jet Routes are published in paragraph 2004 and United States Area Navigation Routes (Q-routes) are published in paragraph 2006 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11G, dated August 19, 2022, and effective September 15, 2022. FAA Order JO 7400.11G is publicly available as listed in the ADDRESSES section of this document. These amendments will be published in the next update to FAA Order JO 7400.11.

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

This action amends 14 CFR part 71 by revoking Jet Route J-184 and establishing RNAV route Q-180 due to service limitations associated with signal coverage issues on J-184. The Air Traffic Service (ATS) route actions are described below.

J-184: J-184 is removed in its entirety.

Q-180: Q-180 is established and extends between the Buckeye, AZ, VORTAC and the Newman, TX, VORTAC NAVAIDs. This new Q-route provides RNAV routing along the same route of flight J-184 provided prior to its removal and retains flight safety and NAS efficiency for aircraft transiting between the Phoenix, AZ, and El Paso, TX, areas.

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 revoking Jet Route J-184 and establishing RNAV route Q-180, due to service limitations associated with signal coverage issues of the Deming, NM, VORTAC 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); and paragraph 5-6.5i, which categorically excludes from further environmental 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:

This rule amends 14 CFR part 97 by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained on FAA form documents is unnecessary. This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.

The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.

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. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, CFR part 97, (is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:

This rule amends 14 CFR part 97 by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, 8260-15B, when required by an entry on 8260-15A, and 8260-15C.

The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers or aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the typed of SIAPS, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPs as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flights safety relating directly to published aeronautical charts.

The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.

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. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, 14 CFR part 97 is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:

FDA is amending 21 CFR chapter I to update Dockets Management Staff's name change and information regarding copies.

Publication of this document constitutes final action on the changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because this amendment to the regulations provides only a technical change to update the organizational information for Dockets Management Staff.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR chapter I is amended as follows:

I. What changes to 22 CFR 41.12, 41.84, and 42.11 does this Final Rule make?

The Department is amending 22 CFR 41.12 to include classification symbols and related descriptions for the CW-1, CW-2, E-2C, and T-6 visa classifications. The Department is also amending 22 CFR 42.11 to include classification symbols and related descriptions for surviving spouses and children, as described in Section 403(a) of the Emergency Security Supplemental Appropriations Act, 2021 (“ESSAA”), Public Law 117-31, 135 Stat. 309, as well as classification symbols and related descriptions for EB-5 immigrant visas initiated by the EB-5 Reform and Integrity Act of 2022, Division BB of the Consolidated Appropriations Act, 2022, Public Law 117-103 (“EB-5 Reform and Integrity Act”). The changes in the classification descriptions under this Final Rule will have no impact on who may qualify for such a visa; as such, this Final Rule will not practically impact any current applicant for any visa. This rule also makes technical corrections to the classification symbols for visa classifications to ensure the accurate inclusion of all active immigrant visa classifications.

The Trafficking Victims Protection Reauthorization Act of 2008, Public Law 106-386 amended Section 101(a)(15)(T)(ii)(III) of the INA to include parents and unmarried siblings under the age of 18 whose eligibility for T derivative classification is not tied to the age of the principal applicant, but rather to their present danger of retaliation as a result of the principal's escape from trafficking or cooperation with law enforcement, as determined by U.S. Citizenship and Immigration Services. These derivatives receive T-4 and T-5 visa classifications. Additionally, Section 1221 of the Violence Against Women Reauthorization Act of 2013, Public Law 113-4, amended Section 101(a)(15)(T)(ii)(III) of the INA by adding the T-6 derivative classification, which is available to an eligible adult or minor child of a T-1 principal applicant's derivative family member, if such derivative's adult or minor child themself faces a present danger of retaliation as a result of the principal's escape from trafficking or cooperation with law enforcement.

Classification symbols in existing regulations at 22 CFR 41.12 do not reflect the 2013 expansion of eligibility for the adult or minor child of a derivative beneficiary, and to address this, this rule amends 22 CFR 41.12 to add the T-6 classification symbol and description. This rule also adds details to existing descriptions of the T-4 and T-5 visa classification to better reflect the statutory criteria. The rule further amends 22 CFR 41.84 to reflect the current language more closely in INA section 101(a)(15)(T)(ii) which describes the family members who may qualify for T nonimmigrant status as certain accompanying or following-to-join derivative family members of a principal T-1 nonimmigrant. These classification codes are consistent with those used by the Department of Homeland Security.

Section 6 of the Covenant to Establish a Commonwealth of the Northern Mariana Islands in Political Union with the United States of America, Public Law 94-241, as amended by Section 702(a) of the Consolidated Natural Resources Act of 2008, Public Law 110-229, provides for nonimmigrant visas for certain CNMI transitional workers, investors, and their spouses and children. The Department classifies CNMI transitional workers as CW-1, spouses, or children of a CW-1 as a CW-2, and CNMI investors and their spouses or children as E-2C. This rule adds these nonimmigrant visa classifications to 22 CFR 41.12. These classification codes are consistent with those used by the Department of Homeland Security.

Section 403(a) of the ESSAA amended INA Section 101(a)(27)(D), 8 U.S.C. 1101(a)(27)(D), to change the definition of a special immigrant to include “the surviving spouse or child of an employee of the United States Government abroad: Provided, [t]hat the employee performed faithful service for a total of not less than 15 years or was killed in the line of duty.” The Department classifies each surviving spouse and child of an employee of the United States Government abroad as an SS1. While this Final Rule does not address the parameters under which a noncitizen may qualify for issuance of an SS1 immigrant visa, this rule adds these special immigrant visa classifications to 22 CFR 42.11.

The EB-5 Reform and Integrity Act made substantial changes to Section 203(b)(5) of the INA, 8 U.S.C. 1153(b)(5). The EB-5 Reform and Integrity Act sets forth an allocation of visas to qualified immigrant investors who invest in new commercial enterprises and satisfy applicable job creation requirements. Certain percentages of these visas are reserved for investors in rural areas, investors in areas designated by the Department of Homeland Security (DHS) as high unemployment areas, and investors in infrastructure projects.

The EB-5 Reform and Integrity Act repealed the former Regional Center Program under section 610 of Public Law 102-395 and authorized a new Regional Center Program. As a result of the new legislation, the Visa Office is adding new EB-5 classification symbols. An investor in a non-regional center for an unreserved visa is classified as NU-1 and the spouse and children of an NU-1 applicant are classified as an NU-2 and NU-3, respectively. An investor in a regional center for an unreserved visa is classified as an RU-1 applicant, and the spouse and children of an RU-1 applicant are classified as an RU-2 and RU-3, respectively. An applicant for a reserved visa who is an investor in a non-regional center in a rural area is classified as an NR-1, and the spouse and children of an NR-1 applicant are classified as an NR-2 and NR-3, respectively. An applicant for a reserved visa who is an investor in a non-regional center in an area with high unemployment is classified as an NH-1, and the spouse and children of an NH-1 applicant are classified as an NH-2 and NH-3, respectively. An applicant for a reserved visa who is an investor in a regional center in a rural area is classified as an RR-1, and the spouse and children of an RR-1 applicant are classified as an RR-2 and RR-3, respectively. An applicant for a reserved visa who is an investor in a regional center in an area of high unemployment is classified as an RH-1, and the spouse and children of an RH-1 applicant are classified as an RH-2 and RH-3, respectively. An applicant for a reserved visa who is an investor in an infrastructure project is classified as an RI-1, and the spouse and children of an RI-1 applicant are classified as an RI-2 and RI-3, respectively. The previously used visa classifications for employment fifth preference immigrant visas (C51, C52, C53, T51, T52, T53, R51, R52, R53, I51, I52, and I53) will continue to be used for EB-5 immigrant visa applicants who had petitions pending with DHS at the time of the passage of the EB-5 Reform and Integrity Act. These classification symbols and descriptions are currently in use, and merely reflect the availability of these classifications for qualified applicants. The publication of these symbols will not impact processing of visas in other categories for any current or future applicant. These classification symbols are consistent with those used by the Department of Homeland Security.

Additionally, this rule makes a technical change to remove a reference to H2R, which is a classification symbol no longer in use. The H2R nonimmigrant visa classification was introduced by Section 402 of the Emergency Supplemental Appropriations Act for Defense, the Global War on Terror, and Tsunami Relief, 2005, Public Law 109-13, as amended by Section 565 of the Consolidated Appropriations Act, 2016, Public Law 114-113. The H2R nonimmigrant visa classification was only authorized through the end of the 2016 fiscal year and has not been reauthorized.

President Biden's Executive Order 14012, Executive Order on Restoring Faith in Our Legal Immigration Systems and Strengthening Integration and Inclusion Efforts for New Americans (Feb. 2, 2021), affirms that the “Federal Government should develop welcoming strategies that promote integration [and] inclusion.” That Executive Order and Executive Order 14010, Creating a Comprehensive Regional Framework to Address the Causes of Migration, to Manage Migration Throughout North and Central America, and to Provide Safe and Orderly Processing of Asylum Seekers at the United States Border (Feb. 2, 2021), do not use the terms “alien” or “illegal alien” to describe migrants.

Some opinions of the Supreme Court now use the term “noncitizen” in place of “alien.” See, e.g., United States v. Palomar-Santiago, 141 S. Ct. 1615, 1619 (2021); Barton v. Barr, 140 S. Ct. 1442, 1446 n.2 (2020) (“This opinion uses the term `noncitizen' as equivalent to the statutory term `alien.' ”) (citing 8 U.S.C. 1101(a)(3)). 1 Other agencies have begun to use noncitizen in place of alien in regulations and guidance and the Department has been using noncitizen and applicant in place of alien in guidance to consular officers since mid-2021. The Department intends to gradually replace or remove references to alien as it makes other amendments to its regulations in 22 CFR parts 41, and 42, and has done so in several descriptions of its nonimmigrant and immigrant visa classifications in this rule.

The publication of this rule as a final rule is based upon the “good cause” exception found at 5 U.S.C. 553(b)(3)(B) and (d)(3). A rule benefits from the good cause exception when the “agency for good cause finds . . . that notice and public procedure thereon are impractical, unnecessary, or contrary to the public interest.”  1 The Department finds that notice and comment for this rule are unnecessary as this rule proposes no new policy or procedure. This rule merely updates the list of classification symbols found in 22 CFR 41.12 and 42.11 to more closely reflect the classifications authorized under the Immigration and Nationality Act and other federal statutes; and provides clarifying descriptions in the associated classification-specific subsections.

For this reason, this rule is excepted from the notice and comment requirements of 5 U.S.C. 553(a)(1).

As this final rule is excepted from notice and comment rulemaking under 5 U.S.C. 553(b) and 553(a), it is exempt from the regulatory flexibility analysis requirements set forth by the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ).

The Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532, generally requires agencies to prepare a statement before proposing any rule that may result in an annual expenditure of $100 million or more by State, local, or Tribal governments, or by the private sector. This rule does not require the Department of State to prepare a statement because it will not result in any such expenditure, nor will it significantly or uniquely affect small governments. This rule involves visas, which involve foreign individuals, and does not directly or substantially affect state, local, or tribal governments, or businesses.

This rule is not a major rule as defined in 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based companies to compete with foreign-based companies in domestic and import markets.

Executive Orders 12866 and 13563 direct agencies to assess costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributed impacts, and equity). These Executive Orders stress the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The Department of State has examined this rule considering Executive Order 13563 and has determined that the rulemaking is consistent with the guidance therein. The Department of State has reviewed this rulemaking to ensure its consistency with the regulatory philosophy and principles set forth in Executive Order 12866. The Office of Information and Regulatory Affairs has designated this rule “significant” in accordance with E.O. 12866. There are no anticipated direct costs to the public associated with this rule.

This regulation will not have substantial direct effect on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. Nor will the rule have federalism implications warranting the application of Executive Orders 12372 and 13132.

The Department of State has reviewed the rule considering sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.

The Department of State has determined that this rulemaking will not have Tribal implications, will not impose substantial direct compliance costs on Indian Tribal governments, and will not pre-empt Tribal law. Accordingly, the requirements of Section 5 of Executive Order 13175 do not apply to this rulemaking.

This rule does not impose any new reporting or record-keeping requirements subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 35.

Accordingly, for the reasons stated in the preamble, and under the authority 8 U.S.C. 1104 and 22 U.S.C. 2651(a), 22 CFR parts 41 and 42 are amended as follows:

Purpose

The USPTO amends 37 CFR parts 1 and 11 to better protect the public and improve compliance with the requirements of part 11. 35 U.S.C. 2(b)(2)(A) and 2(b)(2)(D) provide the USPTO with the authority to establish regulations to govern “the conduct of proceedings in the Office” and “the recognition and conduct of agents, attorneys, or other persons representing applicants or other parties before the Office,” respectively. Title 37 CFR part 11 contains those regulations that govern the representation of others before the USPTO, including regulations related to the recognition to practice before the USPTO, investigations, disciplinary proceedings, and the USPTO Rules of Professional Conduct.

The USPTO formalizes its OED Diversion Pilot Program (Pilot Program) initiated in September 2017 for patent and trademark practitioners whose physical or mental health issues or law practice management issues resulted in minor misconduct. The public has been supportive of the Pilot Program. Making the Pilot Program permanent will proactively encourage practitioners to address the root causes of their misconduct so that they may provide valuable service to the public. It aligns the USPTO's disciplinary practice with a majority of state attorney disciplinary systems.

The USPTO also requires foreign attorneys or agents granted reciprocal recognition in trademark matters to provide and update their contact and licensure status information or have their recognition withdrawn in order to provide the public with current information.

Certain state attorney licensing authorities have begun permitting alternative business structures between an attorney and a non-attorney, generally consisting of an arrangement where the non-attorney is permitted to partner with the attorney in the practice of law, possess an ownership interest in a law firm, or otherwise share in legal fees. However, such arrangements were previously prohibited by the USPTO Rules of Professional Conduct, creating potential conflicts for patent and trademark practitioners who are licensed to practice law in those states. Therefore, this rule changes the USPTO Rules of Professional Conduct so that, hereafter, the USPTO defers to a state's attorney licensing authority regarding certain aspects pertaining to the sharing of legal fees between a practitioner and a non-practitioner in order to reduce the potential for such conflicts.

Lastly, the USPTO makes revisions to promote efficiency and clarity in its regulations, such as to remove a fee required when changing one's status from a patent agent to a patent attorney in order to encourage more practitioners to update their status; align the rule governing the limited recognition of persons ineligible to become registered to practice before the Office in patent matters because of their immigration status with existing practice; clarify procedures and improve efficiencies regarding disciplinary proceedings and appeals; and remove a reference to “emeritus status.”

The USPTO amends part 11 to formalize its OED Diversion Pilot Program for patent and trademark practitioners whose physical or mental health issues or law practice management issues resulted in minor misconduct. For example, a practitioner who lacked diligence in a matter due to a law practice management issue that resulted in minimal impact on their clients and/or the public may wish to consider diversion. The program allows those practitioners to avoid formal discipline by successfully completing diversion agreements with the OED Director. The goal of the program is to help practitioners address the root causes of such misconduct and adhere to high standards of ethics and professionalism in order to provide valuable service to the public.

Diversion is intended to be an action that the OED Director may take to dispose of a disciplinary investigation. The program is not typically available to a practitioner after the filing of a disciplinary complaint by the OED Director under 37 CFR 11.34. However, in extraordinary circumstances, the OED Director may enter into a diversion agreement with an eligible practitioner after a complaint has been filed. If diversion is requested after a complaint has been filed, the matter will be referred to the OED Director for consideration. The terms of any diversion agreement will be determined by the OED Director and the practitioner.

In 2017, the USPTO initiated the OED Diversion Pilot Program for patent and trademark practitioners. The USPTO extended the Pilot Program until November 15, 2023 or until a formalized program superseded the pilot. See Extension of Diversion Pilot Program, 1503 OG 314 (Oct. 18, 2022). The Pilot Program has enabled practitioners to successfully implement specific remedial measures and improve their practice, and the USPTO received public comment urging that the Pilot Program be incorporated into part 11. See Changes to Representation of Others Before the United States Patent and Trademark Office, 86 FR 28442, 28446 (May 26, 2021). This final rule amends part 11 to formalize the Pilot Program, thus emphasizing the USPTO's commitment to wellness within the legal profession and aligning the USPTO with the practices of more than 30 attorney disciplinary systems in the United States.

The criteria for participation are set forth at 37 CFR 11.30. The criteria address eligibility, completion of the program, and material breaches of the diversion agreement. (Any other aspects of diversion not fully addressed in § 11.30, such as specific details regarding the material breach of an agreement, will be addressed in individualized diversion agreements.) Based on the American Bar Association Model Rules for Lawyer Disciplinary Enforcement, the criteria also draw from experience gained during the administration of the Pilot Program. Specifically, the criteria now allow practitioners who have been disciplined by another jurisdiction within the past three years to participate if the discipline was based on the conduct that forms the basis for the OED Director's investigation. For example, participation in the USPTO's diversion program may be appropriate in cases in which the practitioner was recently publicly disciplined by a jurisdiction that does not have a diversion program. See Changes to Representation of Others Before the United States Patent and Trademark Office, 86 FR 28442, 28443 (May 26, 2021). Additional experience gained from the Pilot Program also indicated that eligibility could be extended to practitioners evidencing a pattern of similar misconduct if the misconduct at issue is minor and related to a chronic physical or mental health condition or disease. Under the Pilot Program criteria, practitioners recently disciplined by another jurisdiction and practitioners evidencing a pattern of similar misconduct were not eligible to participate.

The OED Director may consider all relevant factors when determining whether a practitioner meets the criteria. See generally, Model Rules of Lawyer Disciplinary Enforcement Rule 11 cmt. (American Bar Association, 2002) (“Both mitigating and aggravating factors should also be considered. The presence of one or more mitigating factors may qualify an otherwise ineligible respondent for the program.”).

The USPTO believes that the diversion program is a valuable tool that will benefit the public by fostering the skills and abilities of those individuals who represent others before the USPTO. Additional information may be found in a diversion guidance document, available at https://www.uspto.gov/sites/default/files/documents/OED-Diversion-Guidance-Document.pdf.

The USPTO amends § 11.14 to ascertain the licensure status and contact information of foreign attorneys or agents who are granted reciprocal recognition in trademark matters under § 11.14(c)(1). The amendments in this final rule provide potential clients with more certainty regarding the good standing of a foreign attorney or agent.

This final rule requires that any foreign attorney or agent granted reciprocal recognition in trademark matters under § 11.14(c)(1) must provide the OED Director their postal address, at least one and up to three email addresses where they receive email, and a business telephone number, as well as any change to their postal address, email addresses, and business telephone number, within 30 days of the date of any change. A foreign attorney or agent granted reciprocal recognition under § 11.14(c)(1) must also notify the OED Director of any lapse in their authorization to represent clients before the trademark office in the country in which they are registered and reside within 30 days of the lapse.

The USPTO also amends the rules of practice so that the OED Director may address a letter to any foreign attorney or agent granted reciprocal recognition under § 11.14(c)(1) for the purposes of ascertaining the validity of the foreign attorney or agent's contact information and good standing with the trademark office or other duly constituted authority in the country in which they are registered and reside (for Canadian trademark agents, the term “trademark office” shall mean the College of Patent Agents and Trademark Agents with respect to matters of practice eligibility in Canada). Any such foreign attorney or agent failing to reply and provide any information requested by the OED Director within a time limit specified will be subject to having their reciprocal recognition withdrawn by the OED Director. Withdrawal of recognition by the OED Director does not obviate the foreign attorney's or agent's duty to comply with any other relevant USPTO rules, such as the requirement to withdraw from pending trademark matters.

Unless good cause is shown, the OED Director shall promptly withdraw the reciprocal recognition of foreign attorneys or agents who: (1) are no longer eligible to represent others before the trademark office of the country upon which reciprocal recognition is based, (2) no longer reside in such country, (3) have not provided current contact information, or (4) failed to reply to the letter from the OED Director within the time limit specified and/or provide any of the information requested by the OED Director in that letter. The amended rule requires the OED Director to publish a notice of any withdrawal of recognition.

Lastly, in this final rule the USPTO amends the rules of practice so that any foreign attorney or agent whose recognition has been withdrawn may reapply for recognition upon submission of a request to the OED Director and payment of the application fee in § 1.21(a)(1)(i), as provided under amended § 11.14(f).

This final rule amends § 11.9(b) in regard to limited recognition for individuals who are neither U.S. citizens nor lawful permanent residents, but who nevertheless have been granted status and the authority to work in the United States by the U.S. Government in order to practice before the USPTO in patent matters. Specifically, the USPTO removes the term “nonimmigrant alien” from § 11.9(b) because the term does not include all individuals eligible for limited recognition under this provision. For example, the term “nonimmigrant alien” does not include all individuals who are neither U.S. citizens nor lawful permanent residents, but who nevertheless have been granted status and the authority to work in the United States by the U.S. Government. Rather, the appropriate description for those who may qualify for limited recognition includes individuals who: (1) are ineligible to become registered under § 11.6 because of their immigration status, (2) are authorized by the U.S. Government to be employed or trained in the United States to represent a patent applicant by preparing or prosecuting a patent application, and (3) meet the requirements of paragraphs (d) and (e) of § 11.9. This revision results in no change in practice.

In this final rule, the USPTO amends § 11.9(b) to clarify that limited recognition to practice before the USPTO in patent matters for individuals who are neither U.S. citizens nor lawful permanent residents, but who nevertheless have been granted status and the authority to work in the United States by the U.S. Government, shall not be granted or extended to non-U.S. citizens residing outside the United States. This is consistent with current practice in which an individual's limited recognition will not terminate if the individual has been approved by the U.S. Government to temporarily depart from the United States, but will terminate when the individual ceases to reside in the United States.

In this final rule, the USPTO eliminates the $110.00 fee in § 1.21(a)(2)(iii) that is charged when a registered patent agent changes their registration from an agent to an attorney. It is expected that the removal of this fee will improve the accuracy of the register of patent attorneys and agents by incentivizing patent agents who become patent attorneys to promptly update their status in that register.

This final rule adds § 11.504(e) to address when a practitioner enters into an arrangement to share legal fees with a non-practitioner, to form a partnership with a non-practitioner, or to be part of a for-profit association or corporation owned by a non-practitioner. In the event of such arrangement, § 11.504(e) is intended to defer to the attorney licensing authority of the State(s) (as defined in § 11.1, “any of the 50 states of the United States of America, the District of Columbia, and any commonwealth or territory of the United States of America”) that affirmatively regulate(s) such arrangement, in order to avoid a conflict between § 11.504(a), (b), and (d)(1) and (2) of the USPTO Rules of Professional Conduct and the laws, rules, and regulations of the attorney licensing authority of any such State(s). It is further intended to treat an attorney subject to the USPTO Rules of Professional Conduct and a registered patent agent similarly when both participate together in the same such arrangement. No deference to an attorney licensing authority of a State is intended when that licensing authority has no laws, rules, and regulations that address such arrangement or the State does not affirmatively regulate such arrangement.

However, the added flexibility does not obviate the practitioner's obligations under any other USPTO rules, including the USPTO Rules of Professional Conduct, that may be relevant to such an arrangement. Further, this addition does not permit a person who recommends, employs, or pays the practitioner to render legal services for another to direct or regulate the practitioner's professional judgment in rendering such legal services as described in § 11.504(c), nor does this addition permit the practitioner to practice with or in the form of a professional corporation or association authorized to practice law for a profit, if a non-practitioner has the right to direct or control the professional judgment of the practitioner as described in § 11.504(d)(3).

In this final rule, the USPTO amends § 11.43 to clarify that, while all motions must set forth a basis for the requested relief, including a concise statement of the facts and arguments along with a citation of the authorities upon which the movant relies, (1) only motions for summary judgment and motions to dismiss are required to be accompanied by a written memorandum setting forth that basis, and (2) the prescribed time periods to file response and reply memoranda regarding such motions only apply to motions for summary judgment and motions to dismiss. While parties must provide support for all motions, limiting memoranda and the specified briefing schedule to motions for summary judgment and motions to dismiss promotes the goal of continued efficient progress of disciplinary proceedings. Hearing officers retain the discretion to order memoranda and set time limits for other types of motions and papers.

This final rule amends § 11.44(a) to clarify that hearings may be held by videoconference. The amendment reflects the current practice of scheduling and conducting remote hearings. The amendment also clarifies that the transcript of the hearing need not be created by a stenographer.

In this final rule, the USPTO amends § 11.52 to improve the procedures for written discovery in disciplinary proceedings and to order those procedures in a more chronological fashion. Accordingly, the contents of paragraphs (a) and (b) are restructured into revised paragraphs (a), (b), and (c). Former paragraph (c) is redesignated as paragraph (d), and the cross-reference to former paragraph (a) is updated. Former paragraphs (d) through (f) are redesignated as paragraphs (e) through (g).

First, under paragraph (a), the amended rule sets forth the types of requests for which a party may seek authorization in a motion for written discovery. While the previous rule sets forth that information in paragraph (b), the amended rule logically sets forth that information in paragraph (a) because paragraph (a) pertains to the content of the initial motion for written discovery.

Second, under paragraph (b), the amended rule requires a copy of the proposed written discovery requests and a detailed explanation, for each request made, of how the discovery sought is reasonable and relevant to an issue actually raised in the complaint or the answer. Any response to the motion shall include specific objections to each request, if any. Any objection not raised in the response will be deemed to have been waived.

Third, under paragraph (c), the amended rule requires the moving party to serve a copy of any authorized discovery requests following the issuance of an order authorizing discovery within a default deadline of five days following the order. This requirement ensures that the opposing party promptly receives a copy of the authorized requests to which the party must respond. Amended paragraph (c) also sets a default deadline of 30 days from the date of service of the authorized requests for the opposing party to serve responses. Setting the default period to begin on the date of service provides the opposing party a predictable and definitive time period for responding to authorized discovery requests in circumstances in which the hearing officer's order does not specify a different deadline.

In this final rule, the USPTO amends § 11.55(m) to remove the requirement to submit a supporting affidavit when moving for an extension of time to file a brief regarding an appeal of the initial decision of a hearing officer and to place the amended requirement to file a motion for an extension in a new paragraph (p) at the end of § 11.55. Affidavits are removed to eliminate an unnecessarily burdensome requirement in requesting the extension of time, while retaining the necessity to show good cause. The provision is moved to the new paragraph (p) because it logically falls at the end of § 11.55.

The USPTO removes the reference to “emeritus status” in § 11.19(a) because no such status was ever finalized and inadvertently remains from a previous rulemaking.

The USPTO published a proposed rule on September 8, 2022, at 87 FR 54930, soliciting comments on the proposed amendments to 37 CFR parts 1 and 11. The USPTO received five unique comments from four organizations and one individual. These comments are publicly available at the Federal eRulemaking Portal at www.regulations.gov. The Office received comments both generally supporting and objecting to the revisions to the rules of practice. A summary of the comments and the USPTO's responses are provided below.

Comment 1. Two commenters support the proposal to formalize the USPTO's Diversion Pilot Program. One commenter encourages expanding the eligibility criteria for participation and increasing the use of the program.

Response 1. The USPTO appreciates the support for formalizing its Diversion Pilot Program. The eligibility criteria for participation in the Diversion Program are set forth in 37 CFR 11.30 in this final rule. The criteria are based upon the American Bar Association Model Rules for Lawyer Disciplinary Enforcement (amended August 12, 2002) and are now broadened based on experience gained during the Pilot Program. Specifically, eligibility is extended to a practitioner who evidences a pattern of similar misconduct if the misconduct at issue is minor and related to a chronic physical or mental health condition or disease. Eligibility is also extended to a practitioner who has been disciplined by another jurisdiction within the past three years as long as the discipline was based on the conduct that forms the basis for the OED Director's investigation. Under the Pilot Program, a practitioner who evidenced a pattern of similar misconduct or a practitioner who was recently disciplined by their state bar was not eligible to participate. The USPTO believes that the Diversion Program is a valuable proactive tool that will provide a practitioner the opportunity to curtail future misconduct. Accordingly, the USPTO will continue to evaluate the eligibility criteria over the course of the program.

Comment 2. Two commenters express concerns regarding the proposal to require a written memorandum of law only for a motion for summary judgment or a motion to dismiss. Specifically, the commenters contend that the proposal may impact the due process rights of respondents; eliminate memoranda of law in other important motions; and impact the ability of the respondent (and tribunal) to understand the relevant facts, the applicable law, and the application of the law to the facts in support of the relief requested. The commenters also express concern that no data or objective evidence has been provided in support of a benefit to respondents when motions unsupported by a memorandum of law are filed against them. The commenters suggest that the USPTO should either withdraw the proposal or amend it to permit a motion to be filed without a supporting memorandum of law only for narrowly defined, non-substantive issues.

Response 2. The USPTO appreciates the comments and, after review and consideration, has amended 37 CFR 11.43 to clarify that each motion must set forth a basis for the requested relief, including a concise statement of the facts and supporting reasons, along with a citation of the authorities upon which the movant relies. The amended text requires the moving party to advance in their motion any facts and supporting reasons deemed necessary to support the requested relief. The USPTO notes that the prior provision in 37 CFR 11.43 that required memoranda to accompany all motions had only been in place since June 25, 2021. Before then there was no requirement that a motion be accompanied by a memorandum of law. Instead, the form and content of motions and accompanying papers were governed by the hearing officer's orders, which typically required all motions to be so accompanied. However, respondents who are unrepresented by counsel often failed to file memoranda of law with their motions, regardless of the orders. Accordingly, the change to § 11.43 may benefit such unrepresented respondents who may find preparing a memorandum of law burdensome or may overlook the requirement. Nothing in the amended text authorizes or endorses the filing of motions that are not adequately supported by facts, reasons, and legal authorities. Rather, the amendment removes the current requirement that a separate legal memorandum must be filed for all motions and limits the requirement to only certain dispositive motions.

Comment 3. One commenter recommends that in developing policies regarding the use of video hearings, the USPTO may wish to consult Recommendation 2021-4, Virtual Hearings in Agency Adjudication, 86 FR 36083 (July 8, 2021), which identifies best practices for improving existing virtual-hearing programs and establishing new ones in accord with principles of fairness and efficiency and with due regard for participant satisfaction.

Response 3. The USPTO appreciates the comment. The USPTO will endeavor to ensure that hearing officers and the USPTO's counsel keep abreast of recommendations, developments, and updates with respect to virtual hearings, including the referenced Recommendation 2021-4, in order to promote remote hearings that proceed efficiently, fairly, and to the satisfaction of participants.

Comment 4. Three commenters raise concerns in regard to amended 37 CFR 11.44(a), pertaining to remote hearings, stating that disciplinary proceedings are quasi-criminal in nature and that due process must be considered. Two of the commenters particularly assert that respondents and their counsel are entitled to, or should be entitled to, an in-person right to confront witnesses, if so desired.

Response 4. The USPTO appreciates the comments and endeavors to fully protect respondents' due process rights in all disciplinary proceedings, whether conducted remotely or in-person. USPTO disciplinary proceedings provide respondents with notice of the charges against them and opportunities to be heard, explain, and defend themselves. See In re Ruffalo, 390 U.S. 544, 550 (1968). Federal courts have consistently distinguished the rights of respondents in disciplinary cases from those of criminal defendants. See In re Sibley, 564 F.3d 1335, 1341 (D.C. Cir. 2009); Rosenthal v. Justices of the Supreme Court of Cal., 910 F.2d 561, 564 (9th Cir. 1990), cert. denied, 498 U.S. 1087 (1991); In re Stamps, 173 Fed. App'x. 316, 318 (5th Cir. 2006) (per curiam) (unpublished); In re Marzocco, No. 98-3960, 1999 WL 968945, at *1 (6th Cir. 1999) (unpublished). Nonetheless, whether the hearing is held in-person or remotely, respondents have the opportunity to cross-examine witnesses and have the witnesses' credibility evaluated by a neutral hearing officer.

Comment 5. Two commenters express concerns related to subpoenas that may be used in USPTO disciplinary proceedings. The commenters note the geographic limitations of Federal Rule of Civil Procedure 45 and assert that the “place” of hearing for USPTO disciplinary hearings is where the hearing officer is located, not where a witness may be located in the case of a remote hearing. Therefore, the commenters argue that hearing officers can only authorize parties to apply to the court in the jurisdiction where the trial is held to obtain a hearing subpoena and compel the in-person appearance of a witness. Accordingly, the commenters assert that the proposed amendment in regard to remote hearings incorrectly presumes that hearing officers have nationwide hearing subpoena power. The commenters add that the only way to ensure testimony by witnesses outside the subpoena power of a trial court is to have them testify by deposition.

Response 5. The USPTO disagrees with the sentiments in these comments. Although hearing officers do not issue subpoenas, they have the power to authorize the issuance of subpoenas by federal district courts nationwide pursuant to 35 U.S.C. 24 and 37 CFR 11.38, 11.39, and 11.51. The legitimacy and enforceability of a subpoena issued to a witness in a particular disciplinary proceeding may be determined on a case-by-case basis. In addition to authorizing hearing subpoenas, hearing officers may authorize subpoenas for remote depositions and have done so in the past. There is a benefit to hearing officers conducting remote hearings, where they can hear and observe testimony in real time and ask questions of the witness, instead of being presented with deposition transcripts or videos, where the hearing officers have no opportunity to interact with the witness or observe the witness in real time.

Comment 6. Three commenters object to characterizing the amendment in regard to remote hearings as a “clarification” of existing practice. The commenters assert that conducting remote hearings is not authorized by the existing rules and that doing the same since the beginning of the COVID pandemic does not authorize them or make them legitimate. One commenter also noted that members of the public had no way to know that hearing officers had been conducting remote hearings because disciplinary proceedings are subject to the Privacy Act of 1974.

Response 6. The USPTO disagrees with the sentiments in these comments. The amendment reflects existing practice. Hearing officers have invoked their broad authority under 37 CFR 11.39(c) to conduct remote hearings in USPTO disciplinary proceedings. At least one other jurisdiction has also recognized this authority. See Atty. Grievance Commn. of Maryland v. Agbaje, 93 A.3d 262, 275-76 (Md. 2014). It is further noted that the USPTO conducts hearings in proceedings between parties where some or all participants appear remotely. For example, the Trademark Trial and Appeal Board has held such hearings since before the COVID pandemic began, and the Patent Trial and Appeal Board has held numerous remote hearings since the advent of the pandemic. Regarding notice to the public, the amendment expressly states that a virtual hearing is an additional option for the hearing officer. Parties may proactively move for or against a virtual hearing. Further, the amended provision provides notice to the public that a virtual hearing is available, thereby potentially giving the respondent additional time in the early stages of a proceeding either to request and prepare for a remote hearing or to formulate a request against a remote hearing. Nothing in this amendment is intended to preclude or restrict a hearing officer's authority to order an in-person hearing.

Comment 7. Three commenters posit that remote hearings should be available only if a respondent elects one or, similarly, that remote hearings should be available only if both parties agree.

Response 7. The USPTO declines to adopt such a limit on a hearing officer's discretion to order a remote hearing. The amendment does not mandate remote hearings, but rather recognizes that a hearing officer may exercise discretion to order a hearing to be remote in whole or in part. Hearing officers will need to consider various factors in determining whether to conduct a remote hearing in whole or in part, including but not limited to the stated preferences and needs of the parties. For example, remote hearings may reduce the cost of the disciplinary proceeding for the Office and respondent. See generally, 37 CFR 11.60(d)(1).

Comment 8. One commenter states that the phrase “the hearing officer shall set the time and place for the hearing” in 37 CFR 11.44(a) refers to a physical location, and states that virtual hearings depart from this meaning.

Response 8. To the extent that the commenter appears to suggest that the quoted phrase obviates the possibility of remote hearings, the USPTO disagrees because amended 37 CFR 11.44(a) explicitly provides for remote hearings. Further, hearing officers have invoked their broad authority under 37 CFR 11.39(c) to “determine the time and place of any hearing and regulate its course and conduct” to include conducting the hearing via videoconference. In addition, at least one tribunal has found that the parties, witnesses, and hearing officers are still “located” at some place during a remote proceeding, just simply not all at the same location. See Legaspy v. Fin. Indus. Regul. Auth., Inc., No. 20 C 4700, 2020 WL 4696818, at *3 (N.D. Ill. Aug. 13, 2020).

Comment 9. Three commenters express support for the amendment to require reciprocally recognized trademark practitioners to update their contact information with the USPTO within 30 days of any changes thereto. One commenter expresses a concern, however, that such requirement lacks an effective enforcement mechanism. As such, the commenter suggests imposing escalating fees for late submissions of contact information updates. The commenter posits that the threat of penalties would increase compliance with the new rule. Finally, the commenter appears to suggest that practitioners who are late in providing updated contact information by a full year, should be automatically removed from the rolls.

Response 9. The USPTO declines to impose such new fees at this time because the public would not have had a chance to review and comment on the proposal. The USPTO also declines to create automatic removal provisions because such provisions may implicate the Administrative Procedure Act's requirements to provide notice and a hearing before a license may be revoked.

Comment 10. One commenter suggests that the text requiring a foreign attorney or agent granted reciprocal recognition in trademark matters to provide and update their contact information with the USPTO be included under 37 CFR 11.11(a) which currently requires a registered patent practitioner and any person granted limited recognition under 37 CFR 11.9(b) to provide and update their contact information. The commenter appears to make the suggestion under the understanding that “those who have reciprocal recognition are granted limited recognition.”

Response 10. The USPTO thanks the commenter for the suggestion. Assuming the USPTO correctly understands the suggestion, the USPTO wishes to clarify there is no overlap between the categories of: (1) foreign trademark practitioners who are reciprocally recognized to practice before the USPTO in certain trademark matters under 37 CFR 11.14 as long as they do not reside in the United States, and (2) foreigners who reside in the United States and are granted limited recognition to practice before the USPTO in patent matters under 37 CFR 11.9.

Comment 11. One commenter supports in principle the proposed amendment to defer to the laws, rules, and regulations of the attorney licensing authority of the State of a practitioner who enters into an arrangement to share legal fees with a non-practitioner, form a partnership with the non-practitioner, or be part of an organization owned by a non-practitioner. However, the commenter believes that the USPTO should undertake further study and review of the potential outcomes resulting from the amendment, as well as review the efforts of the American Bar Association and other jurisdictions as they modify and interpret their rules to clarify or reconsider existing positions on alternative business arrangements with non-attorneys. Another commenter views the sharing of legal fees with non-attorneys as inconsistent with the core values of the legal profession but recognizes that some jurisdictions now permit such fee-sharing and others may follow. Accordingly, the commenter notes that fear of violating the then-effective rule, which generally prohibited such arrangements, may have made practitioners who are admitted to a jurisdiction that permits such fee sharing reluctant to enter into the same. Therefore, while the commenter appreciates the USPTO's clarity, the commenter suggests that the USPTO monitor the use of non-practitioners to make filings, as well as the commoditization of legal services by non-practitioner owned companies.

Response 11. The USPTO appreciates these comments as well as the concerns identified. The USPTO will continue to consider the potential and actual outcomes of the addition of 37 CFR 11.504(e) as well as related changes in other jurisdictions. The USPTO notes prior reports by Supreme Court of Arizona's Task Force on the Delivery of Legal Services in 2019, which preceded that state's elimination of the equivalent of 37 CFR 11.504; the State Bar of California Task Force on Access through Innovation of Legal Services' Final Report and Recommendations in 2020, which appear to have been partially implemented; and the Utah Supreme Court's Standing Order No. 15 of 2020 (as amended in 2021) implementing changes to the equivalent of 37 CFR 11.504. The USPTO also notes that Georgia has implemented changes very similar to this final rule's addition of 37 CFR 11.504(e) in Georgia Rule of Professional Conduct 5.4(e) and (f).

In regard to the second commenter's concern regarding the use of non-practitioners to make filings, the USPTO notes that existing provisions regarding who may practice before the USPTO, prohibitions regarding the unauthorized practice of law before the USPTO, and provisions on who may properly present a document to the USPTO remain unchanged. In addition to the suggestions of the commenters, the USPTO has identified a situation of concern in which a registered patent agent ( i.e., a non-attorney registered to practice before the Office in patent matters) could be in violation of the proposed 11.504(e) even though an attorney in the same firm who is also subject to the USPTO Rules of Professional Conduct would not be in violation of the same provision. As such, the USPTO has simplified proposed 11.504(e) to clarify that a practitioner need not also be authorized to practice law by the attorney licensing authority in the State(s) that affirmatively regulate(s) the arrangement if the arrangement is fully compliant with the laws, rules, and regulations of the attorney licensing authority of any such State(s).

Comment 12. One commenter supports the proposal to eliminate the fee imposed upon a registered patent practitioner for requesting a status change from patent agent to patent attorney. The commenter also requests that the USPTO remove fees to convert an individual's status from limited recognition to either patent agent or patent attorney status, or when a practitioner changes their status from patent attorney to patent agent.

Response 12. The USPTO is unable to consider the removal of additional fees in this rulemaking, as further study will be required.

As discussed in more detail below, the following sections contain changes from the proposed rule:

Section 11.14 is modified after further consideration to clarify that a practitioner granted reciprocal recognition under paragraph (c)(1) shall notify the OED Director of a lapse in authorization within 30 days of the lapse, which was previously unspecified in paragraph (g) but is a logical outgrowth of the proposed rule. The section is further modified to add a header to paragraph (d) in conformity with the other paragraphs of that section. Paragraph (h) is further modified to clarify that the transmission of the letter to a practitioner recognized under paragraph (c)(1) is sufficient rather than receipt. This recognizes the challenge of verifying service on a practitioner who is definitionally located outside the United States per paragraph (c)(1) in light of the duty of the practitioner to be reachable by clients and tribunals in accordance with the USPTO disciplinary rules. Lastly, after further consideration, references to “must” in paragraphs (g) and (h) have been changed to “shall” for consistency with other paragraphs in § 11.14.

Section 11.43 is modified after further consideration and in response to public comment to clarify that each motion must set forth a basis for the requested relief, including a concise statement of the facts and supporting reasons, along with a citation of the authorities upon which the movant relies. This change may benefit unrepresented respondents who may find preparing a memorandum of law burdensome. See Comment and Response 2.

Section 11.52(d) is modified to update a cross-reference in the proposed rule that unintentionally referred to paragraph (a). The cross-reference has been updated to refer to paragraph (c).

Section 11.504(e) is modified after further consideration and in response to public comment to clarify that a practitioner who enters into an alternative business arrangement with a non-practitioner need not also be authorized to practice law by the attorney licensing authority in the State(s) that affirmatively regulate(s) the arrangement if the arrangement is fully compliant with the laws, rules, and regulations of the attorney licensing authority of any such State(s). A registered patent agent and an attorney who participate together in the same such arrangement and are both subject to the USPTO Rules of Professional Conduct are to be treated similarly in regard to § 11.504(a), (b), and (d)(1), and (d)(2) in cases when the attorney licensing authority of any such State(s) affirmatively regulate(s) an alternative business structure with a non-practitioner. Further, these changes clarify that the exception created by § 11.504(e) does not apply when the attorney licensing authority of any such State(s) has no laws, rules, and regulations that address an alternative business structure with a non-attorney, and that the exception does not apply when the State does not affirmatively regulate such arrangement. See Comment and Response 11.

The USPTO eliminates the fee in § 1.21(a)(2)(iii) for changing one's status from a registered patent agent to a registered patent attorney.

The USPTO amends § 11.7(l) to reflect the elimination of the fee set forth in § 1.21(a)(2)(iii).

The USPTO amends § 11.9(b) to remove the term “nonimmigrant alien” and to clarify that limited recognition shall not be granted or extended to a non-U.S. citizen residing outside the United States.

The USPTO amends § 11.14(c)(1) to remove unnecessary references to paragraph (c).

The USPTO amends § 11.14(d) to add a header in conformity with the other paragraphs of that section.

The USPTO amends § 11.14(f) to add references to § 11.14(c)(1) where § 11.14(c) was previously referenced.

The USPTO adds § 11.14(g) to create a requirement for a foreign attorney or agent granted reciprocal recognition under § 11.14(c)(1) to notify the OED Director of updates to contact information within 30 days of the date of the change and to notify the OED Director of any lapse in their authorization to represent clients before the trademark office in the country in which they are registered and reside within 30 days of the date of the lapse.

The USPTO adds § 11.14(h) to ascertain the validity of a reciprocally recognized foreign attorney's or agent's contact information and good standing with the trademark office or other duly constituted authority in the country in which the agent is registered and resides. Any foreign attorney or agent failing to give any information requested by the OED Director within a time limit specified is subject to having their reciprocal recognition withdrawn.

The USPTO adds § 11.14(i) to create a process to withdraw reciprocal recognition of a foreign attorney or agent registered under paragraph (c)(1) if they: (1) are no longer registered with, in good standing with, or otherwise eligible to practice before, the trademark office of the country upon which reciprocal recognition is based; (2) no longer reside in such country; or (3) have not provided current contact information or have failed to validate their good standing with the trademark office in the country in which they are registered and reside as required in amended § 11.14(g) and (h).

The USPTO adds § 11.14(j) to specify that the process for a foreign attorney or agent whose recognition has been withdrawn and who desires to become reinstated is to reapply for recognition under § 11.14(f).

The USPTO amends § 11.19(a) to remove the term “emeritus status.”

The USPTO amends § 11.22(h)(3) and (4) and adds § 11.22(h)(5) to state that the OED Director may dispose of an investigation by entering into a diversion agreement with a practitioner.

The USPTO adds § 11.30 to state the criteria by which the OED Director may enter into a diversion agreement with a practitioner.

The USPTO amends § 11.43 to clarify that all motions shall set forth the basis for requested relief, but prescribed time periods apply to only certain motions and that those motions shall be accompanied by a written memorandum.

The USPTO amends § 11.44(a) to clarify that hearings may be held by videoconference and that the transcript of the hearing need not be created by a stenographer.

The USPTO amends § 11.52 to revise and restructure the contents of paragraphs (a) and (b) into revised paragraphs (a), (b), and (c) to provide clarity regarding certain discovery obligations on the part of the propounding and responding parties. Former paragraph (c) is redesignated as paragraph (d), and the cross-reference to former paragraph (a) is updated. Former paragraphs (d) through (f) are redesignated as paragraphs (e) through (g).

The USPTO amends § 11.55(m) to eliminate the requirement to submit an affidavit of support with a motion for an extension of time to file a brief regarding an appeal to the USPTO Director and to reorganize the section to move to new paragraph (p) the provision allowing the USPTO Director to extend, for good cause, the time for filing such a brief.

The USPTO adds § 11.504(e) to address circumstances when a practitioner enters into an arrangement to share legal fees with a non-practitioner, to form a partnership with a non-practitioner, or to be part of a for-profit association or corporation owned by a non-practitioner. Specifically, § 11.504(e) defers to the attorney licensing authority of the State(s) that affirmatively regulate(s) such arrangement provided such arrangement fully complies with the laws, rules, and regulations of the attorney licensing authority of any such State(s).

The changes in this rulemaking involve rules of agency practice and procedure, and/or interpretive rules. See Perez v. Mortgage Bankers Ass'n, 135 S. Ct. 1199, 1204 (2015) (interpretive rules “advise the public of the agency's construction of the statutes and rules which it administers”) (citations and internal quotation marks omitted); Nat'l Org. of Veterans' Advocates v. Sec'y of Veterans Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 2001) (rule that clarifies interpretation of a statute is interpretive); Bachow Commc'ns Inc. v. FCC, 237 F.3d 683, 690 (D.C. Cir. 2001) (rules governing an application process are procedural under the Administrative Procedure Act); Inova Alexandria Hosp. v. Shalala, 244 F.3d 342, 350 (4th Cir. 2001) (rules for handling appeals are procedural where they do not change the substantive standard for reviewing claims).

Accordingly, prior notice and opportunity for public comment for the changes in this rulemaking are not required pursuant to 5 U.S.C. 553(b) or (c), or any other law. See Perez, 135 S. Ct. at 1206 (notice-and-comment procedures are not required when an agency “issue[s] an initial interpretive rule” or when it amends or repeals that interpretive rule); Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), do not require notice-and-comment rulemaking for “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice”) (quoting 5 U.S.C. 553(b)(A)). Nevertheless, the USPTO has chosen to seek public comment before implementing the rule to benefit from the public's input.

For the reasons set forth in this rulemaking, the Senior Counsel for Regulatory and Legislative Affairs, Office of General Law, of the USPTO, has certified to the Chief Counsel for Advocacy of the Small Business Administration that the changes in this rule will not have a significant economic impact on a substantial number of small entities. See 5 U.S.C. 605(b).

This rule eliminates the $110.00 fee that is charged when a registered patent agent changes their registration from an agent to an attorney to incentivize patent agents who become patent attorneys to promptly update their status in the register. This change is expected to impact approximately 340 patent agents each year. Patent agents who become licensed attorneys are expected to request a change in status in order to accurately convey their status to the public. The USPTO does not collect or maintain statistics on the size status of impacted entities, which would be required to determine the number of small entities that would be affected by the rule. However, assuming that all patent agents impacted by this rule are small entities, the elimination of the fee will not impact a substantial number of small entities because the approximately 340 patent agents do not constitute a significant percentage of the approximately 47,000 patent practitioners registered to appear before the Office. In addition, the elimination of the $110.00 fee will result in a modest benefit to those patent agents, as they are no longer be required to pay the fee when changing their designation from patent agent to patent attorney.

This rule also amends the rules regarding the representation of others before the USPTO by implementing new requirements and clarifying or improving existing regulations to better protect the public. This rule makes changes to the rules governing reciprocal recognition for the approximately 400 recognized foreign attorneys or agents who practice before the Office in trademark matters. These changes require any reciprocally recognized foreign attorney or agent to keep contact information up to date, provide proof of good standing as a trademark practitioner before the trademark office of the country in which they reside, and notify the OED Director of any lapse in their authorization to represent clients before the trademark office in the country in which they are registered and reside. Absent a showing of cause, failure to comply shall result in the withdrawal of the reciprocal recognition, but an opportunity for reinstatement may be offered.

The Office also makes changes to its disciplinary procedures to formalize a diversion program for patent and trademark practitioners who struggle with physical or mental health issues or law practice management issues. The program assists those practitioners in addressing the root causes of those issues, in lieu of formal discipline.

Finally, this rule makes other minor administrative changes to the regulations to simplify and otherwise improve consistency with existing requirements, thereby facilitating the public's compliance with existing regulations, including aligning with existing practice the rule governing practice before the Office by persons ineligible to become registered under § 11.6 because of their immigration status; changing the rule governing the professional independence of a practitioner to allow a practitioner to share legal fees with a non-practitioner, to form a partnership with a non-practitioner, or to be part of a for-profit association or corporation owned by a non-practitioner, provided such arrangement fully complies with the laws, rules, and regulations of the attorney licensing authority of the State(s) that affirmatively regulate(s) such arrangement; clarifying the procedures regarding disciplinary hearings and appeals of the same; and removing an inadvertent reference to “emeritus status.”

These changes to the rules governing the recognition to practice before the Office apply to the approximately 400 reciprocally recognized trademark practitioners who currently appear before the Office and approximately 47,000 patent practitioners registered or granted limited recognition to appear before the Office, as well as licensed attorneys practicing in trademark and other non-patent matters before the Office. The USPTO does not collect or maintain statistics on the size status of impacted entities, which would be required to determine the number of small entities that would be affected by the rule. However, a large number of the changes in this rule are not expected to have any impact on otherwise regulated entities because the changes to the regulations are procedural in nature. The one change that may impose a new requirement is the provision for the approximately 400 reciprocally recognized foreign attorneys or agents to provide contact information and certificates of good standing as trademark practitioners before the trademark offices of the countries in which they reside. However, this provision is not expected to place a significant burden on those foreign attorneys or agents. The changes are expected to be of minimal or no additional burden to those practicing before the Office.

For the reasons discussed above, this rulemaking will not have a significant economic impact on a substantial number of small entities.

This rulemaking has been determined to be significant for purposes of E.O. 12866 (Sept. 30, 1993).

The Office has complied with E.O. 13563 (Jan. 18, 2011). Specifically, the Office has, to the extent feasible and applicable: (1) made a reasoned determination that the benefits justify the costs of the rule; (2) tailored the rule to impose the least burden on society consistent with obtaining the regulatory objectives; (3) selected a regulatory approach that maximizes net benefits; (4) specified performance objectives; (5) identified and assessed available alternatives; (6) involved the public in an open exchange of information and perspectives among experts in relevant disciplines, affected stakeholders in the private sector, and the public as a whole, and provided online access to the rulemaking docket; (7) attempted to promote coordination, simplification, and harmonization across Government agencies and identified goals designed to promote innovation; (8) considered approaches that reduce burdens and maintain flexibility and freedom of choice for the public; and (9) ensured the objectivity of scientific and technological information and processes.

This rulemaking does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under E.O. 13132 (Aug. 4, 1999).

This rulemaking will not: (1) have substantial direct effects on one or more Indian Tribes; (2) impose substantial direct compliance costs on Indian Tribal governments; or (3) preempt Tribal law. Therefore, a Tribal summary impact statement is not required under E.O. 13175 (Nov. 6, 2000).

This rulemaking is not a significant energy action under E.O. 13211 because this rulemaking is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required under E.O. 13211 (May 18, 2001).

This rulemaking meets applicable standards to minimize litigation, eliminate ambiguity, and reduce burden, as set forth in sections 3(a) and 3(b)(2) of E.O. 12988 (Feb. 5, 1996).

This rulemaking does not concern an environmental risk to health or safety that may disproportionately affect children under E.O. 13045 (Apr. 21, 1997).

This rulemaking will not effect a taking of private property or otherwise have taking implications under E.O. 12630 (Mar. 15, 1988).

Under the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq. ), the USPTO will submit a report containing the final rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the Government Accountability Office. The changes in this rulemaking are not expected to result in an annual effect on the economy of $100 million or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises in domestic and export markets. Therefore, this rulemaking is not expected to result in a “major rule” as defined in 5 U.S.C. 804(2).

The changes in this rulemaking do not involve a Federal intergovernmental mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, of $100 million (as adjusted) or more in any one year, or a Federal private sector mandate that will result in the expenditure by the private sector of $100 million (as adjusted) or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 1501 et seq.

This rulemaking will not have any effect on the quality of the environment and is thus categorically excluded from review under the National Environmental Policy Act of 1969. See 42 U.S.C. 4321 et seq.

The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because this rulemaking does not contain provisions that involve the use of technical standards.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) requires that the Office consider the impact of paperwork and other information collection burdens imposed on the public. This rulemaking involves information collection requirements that are subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. The collections of information involved in this rulemaking have been reviewed and previously approved by OMB under OMB control numbers 0651-0012 (Admission to Practice and Roster of Registered Patent Attorneys and Agents Admitted to Practice Before the USPTO) and 0651-0017 (Practitioner Conduct and Discipline).

This rulemaking benefits the public by improving the accuracy of the register of attorneys and agents who are permitted to practice before the USPTO in patent matters. Specifically, removing the fee to change from agent to attorney is expected to incentivize a registered patent agent who is an attorney but has not updated their registration status to do so. The fee removal reduces the estimated cost burdens associated with 0651-0012 by $27,720; (252 respondents × $110 fee = $27,720). Accordingly, the current estimate of patent agents who change to attorney in 0651-0012 are expected to increase from 252 practitioners to the new estimate of at least 340 practitioners.

The expected increase in practitioners who change their registration status will result in a slight hourly burden increase of 44 hours; (88 practitioners × 0.5 hours = 44 hours). The USPTO further estimates that this increase of 88 respondents will add seven hours of recordkeeping burden to 0651-0012; (88 practitioners × 0.083 hours = 7 hours). These burden estimates are based on the prior OMB approved burdens associated with information collection 0651-0012 and may be different from any forecasts mentioned in other parts of this rule. Overall, this final rule adds 51 burden hours and removes $27,720 in cost burdens.

Notwithstanding any other provision of law, no person is required to respond to, nor shall a person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act, unless that collection of information has a currently valid OMB control number.

The USPTO is committed to compliance with the E-Government Act to promote the use of the internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes.

For the reasons set forth in the preamble, the USPTO amends 37 CFR parts 1 and 11 as follows:

I. Executive Summary A. Does this action apply to me?

You may be potentially affected by this action if you own or operate a facility that manufactures, processes, or otherwise uses any chemicals in the diisononyl phthalate (DINP) category. 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. Facilities subject to reporting under EPCRA section 313 include:

• Facilities included in the following NAICS manufacturing codes (corresponding to Standard Industrial Classification (SIC) codes 20 through 39): 311*, 312*, 313*, 314*, 315*, 316, 321, 322, 323*, 324, 325*, 326*, 327*, 331, 332, 333, 334*, 335*, 336, 337*, 339*, 111998*, 113310, 211130*, 212323*, 212390*, 488390*, 512230*, 512250*, 5131*, 516210*, 519290*, 541713*, 541715* or 811490*. *Exceptions and/or limitations exist for these NAICS codes.

• Facilities included in the following NAICS codes (corresponding to SIC codes other than SIC codes 20 through 39): 211130* (corresponds to SIC code 1321, Natural Gas Liquids, and SIC 2819, Industrial Inorganic Chemicals, Not Elsewhere Classified); or 212114, 212115, 212220, 212230, 212290*; or 2211*, 221210*, 221330 (limited to facilities that combust coal and/or oil for the purpose of generating power for distribution in commerce) (corresponds to SIC codes 4911, 4931, and 4939, Electric Utilities); or 424690, 424710 (corresponds to SIC code 5171, Petroleum Bulk Terminals and Plants); 425120 (limited to facilities previously classified in SIC code 5169, Chemicals and Allied Products, Not Elsewhere Classified); or 562112 (limited to facilities primarily engaged in solvent recovery services on a contract or fee basis (previously classified under SIC code 7389, Business Services, NEC)); or 562211*, 562212*, 562213*, 562219*, 562920 (limited to facilities regulated under the Resource Conservation and Recovery Act, subtitle C, 42 U.S.C. 6921 et seq. ) (corresponds to SIC code 4953, Refuse Systems). *Exceptions and/or limitations exist for these NAICS codes.

• Federal facilities.

• Facilities that the EPA Administrator has specifically required to report to TRI pursuant to a determination under EPCRA section 313(b)(2).

A more detailed description of the types of facilities covered by the NAICS codes subject to reporting under EPCRA section 313 can be found at: https://www.epa.gov/toxics-release-inventory-tri-program/tri-covered-industry-sectors. To determine whether your facility would be affected by this action, you should carefully examine the applicability criteria in 40 CFR part 372, subpart B. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

This action is issued under EPCRA sections 313(d), 313(e)(1) and 328, 42 U.S.C. 11023(d), 11023(e)(1) and 11048. EPCRA is also referred to as Title III of the Superfund Amendments and Reauthorization Act of 1986.

EPCRA section 313, 42 U.S.C. 11023, requires owners/operators of certain facilities that manufacture, process, or otherwise use listed toxic chemicals in amounts above reporting threshold levels to report their facilities' environmental releases and other waste management information on such chemicals annually. These facility owners/operators must also report pollution prevention and recycling data for such chemicals, pursuant to PPA section 6607, 42 U.S.C. 13106.

Under EPCRA section 313(c), Congress established an initial list of toxic chemicals subject to EPCRA toxic chemical reporting requirements that was comprised of 308 individually listed chemicals and 20 chemical categories.

EPCRA section 313(d) authorizes EPA to add or delete chemicals from the list and sets criteria for these actions. EPCRA section 313(d)(2) states that EPA may add a chemical to the list if the Administrator determines, in his judgment, that there is sufficient evidence to establish that any of the listing criteria in EPCRA section 313(d)(2) are met. Therefore, to add a chemical, EPA must determine that at least one criterion is met, but need not determine whether any other criterion is met. Conversely, to delete a chemical from the list, EPCRA section 313(d)(3) dictates that EPA must determine that there is not sufficient evidence to establish any of the criteria described in EPCRA section 313(d)(2). The listing criteria in EPCRA section 313(d)(2)(A)-(C) are as follows:

• The chemical is known to cause or can reasonably be anticipated to cause significant adverse acute human health effects at concentration levels that are reasonably likely to exist beyond facility site boundaries as a result of continuous, or frequently recurring, releases.

• The chemical is known to cause or can reasonably be anticipated to cause in humans: cancer or teratogenic effects, or serious or irreversible reproductive dysfunctions, neurological disorders, heritable genetic mutations, or other chronic health effects.

• The chemical is known to cause or can be reasonably anticipated to cause, because of its toxicity, its toxicity and persistence in the environment, or its toxicity and tendency to bioaccumulate in the environment, a significant adverse effect on the environment of sufficient seriousness, in the judgment of the Administrator, to warrant reporting under this section.

EPA often refers to the EPCRA section 313(d)(2)(A) criterion as the “acute human health effects criterion;” the EPCRA section 313(d)(2)(B) criterion as the “chronic human health effects criterion;” and the EPCRA section 313(d)(2)(C) criterion as the “environmental effects criterion.”

Under EPCRA section 313(e)(1), any person may petition EPA to add chemicals to or delete chemicals from the list. EPA issued a statement of policy in the Federal Register of February 4, 1987 (52 FR 3479) providing guidance regarding the recommended content of and format for petitions. On May 23, 1991 (56 FR 23703), EPA issued guidance regarding the recommended content of petitions to delete individual members of the metal compounds categories reportable under EPCRA section 313. EPA published in the Federal Register of November 30, 1994 (59 FR 61432) (FRL-4922-2) a statement clarifying its interpretation of the EPCRA section 313(d)(2) and (d)(3) criteria for modifying the EPCRA section 313 list of toxic chemicals.

In response to a petition, EPA is adding DINP as a category to the list of toxic chemicals subject to the reporting requirements under section 313 of EPCRA. As discussed in more detail later in this document, EPA is concluding that the members of the DINP category meet the EPCRA section 313(d)(2)(B) criterion for listing.

Additionally, as indicated in the supplemental proposal and as is now being finalized via this rulemaking, EPA is listing DINP as a chemical category that includes all branched alkyl di-esters of 1,2 benzenedicarboxylic acid in which alkyl ester moieties contain a total of nine carbons. This category includes but is not limited to the chemicals covered by the CAS numbers and names identified by EPA at the time of this rulemaking. In the supplemental proposal, EPA identified the following chemicals: Diisononyl phthalate (CAS Number 28553-12-0), Branched dinonyl phthalate (CAS Number 71549-78-5), Branched dinonyl phthalate (CAS Number 14103-61-8), and Di(C8-10, C9 rich) branched alkyl phthalate (CAS Number 68515-48-0). EPA has since identified that Bis(7-methyloctyl) phthalate (CAS Number 20548-62-3) and Bis(3-ethylheptan-2-yl) benzene-1,2-dicarboxylate (CAS Number 111983-10-9) also meet the definition of DINP being used for this listing and thus are also being included in the listing at 40 CFR 372.65(c) to assist facilities in identifying members of the DINP chemical category.

Further, in response to public comments and further review of available information, EPA has updated the 2022 Technical Review of DINP (Ref. 1) provided with the supplemental notice of proposed rulemaking (87 FR 48128, August 8, 2022). The updated 2023 Technical Review of DINP (Ref. 2) is in the docket for this rule. For the reasons more fully explained in the updated 2023 Technical Review of DINP (Ref. 2), EPA is now listing the DINP category based on our conclusion that it is reasonably anticipated to cause serious or irreversible reproductive dysfunctions and other serious or irreversible chronic health effects in humans, including developmental, kidney, and liver toxicity. EPA has determined that the DINP can reasonably be anticipated to cause serious or irreversible chronic human health effects at moderately low to low doses and thus data show that DINP has moderately high to high human health toxicity.

As indicated previously, EPCRA section 313(d)(2) states that EPA may add a chemical to the list if the Administrator determines, in his judgment, that there is sufficient evidence to establish that any of the listing criteria in EPCRA section 313(d)(2) are met. Therefore, to add a chemical, EPA must determine that at least one criterion is met, but need not determine whether any other criterion is met. Accordingly, EPA is basing this addition on its conclusion that DINP is reasonably anticipated to cause serious or irreversible reproductive dysfunctions and other serious or irreversible chronic health effects in humans, including developmental, kidney, and liver toxicity.

Given multiple endpoint findings of serious or irreversible chronic noncancer health effects, it was not necessary for the Agency to rely on hazards related to cancer concerns as a basis for a TRI listing of a DINP chemical category. The Agency is not, with this action, taking a position as to whether or not DINP presents cancer concerns that would support a TRI listing of the chemical category. In response to comments received on the supplemental proposal, EPA has updated it hazard analysis to include additional literature on cancer-related research on DINP. However, EPA is forgoing further analysis of this particular topic as it relates to the EPCRA 313 listing criteria. Given forthcoming additional hazard analyses being conducted by the EPA ( e.g., pursuant to section 6 of the Toxic Substances Control Act) and ensuring that the Agency has adequate resources to conduct its other TRI activities, EPA has determined it appropriate to reduce the scope of analysis for purposes of this listing.

EPA is taking this action in response to a petition submitted under EPCRA section 313(e)(1) (Ref.3). In this case, EPA is granting the petition to list DINP. Additional details about the petition are included in the 2000 proposed rule and the 2022 supplemental proposed rule (87 FR 48128, August 8, 2022).

EPA prepared an economic analysis for this action entitled, “Economic Analysis for the Addition of Diisononyl Phthalate Category; Community Right-to-Know Toxic Chemical Release Reporting” (Ref. 4), which presents an analysis of the costs of the addition of the DINP category. EPA estimates that this action would result in an additional 198 to 396 reports being filed annually. EPA estimates that the costs of this action will be approximately $968,546 to $1,935,041 in the first year of reporting and approximately $461,212 to $921,448 in the subsequent years. In addition, EPA has determined that of the 181 to 365 small businesses affected by this action, none are estimated to incur annualized cost impacts of more than 1%. Thus, this action is not expected to have a significant adverse economic impact on a substantial number of small entities.

On September 5, 2000 (65 FR 53681; FRL-6722-3), in response to a petition filed under the EPCRA, EPA issued a proposed rule to add a DINP category to the list of toxic chemicals subject to the reporting requirements under EPCRA section 313 and PPA section 6607. EPA proposed to add this chemical category to the EPCRA section 313 toxic chemical list based on the Agency's preliminary conclusion that this category met the EPCRA chronic human health effects toxicity criterion. In response to comments on the proposal, EPA revised its hazard assessment for DINP and issued a notice of data availability (NODA) requesting comments on the revised hazard assessment (70 FR 34437, June 14, 2005 (FRL-7532-4)). In the NODA, EPA proposed to list DINP based on serious or irreversible chronic health effects including liver, kidney, and developmental toxicity but reserved judgment on whether cancer was an endpoint of concern for DINP. On August 8, 2022 (87 FR 48128; FRL-2425.1-04-OCSPP), EPA published a supplemental proposal, providing updated supporting materials for the proposal ( e.g., hazard assessment for DINP ( i.e., 2022 Technical Review of DINP) (Ref. 1)).

EPA received 15 comments on the supplemental proposed rule. Two comments came from trade associations: the American Chemistry Council (ACC) and the National Association of Chemical Distributors (NACD). Two comments came from environmental/public interest groups: Earthjustice (including Alaska Community Action on Toxics, Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Defend Our Health, Learning Disabilities Association of America, Sierra Club) and Environmental Defense Fund (EDF). One comment also came from an individual company: UPC Technology Corporation (UPC). Nine of the on-topic comments came from both private citizens and an anonymous commenter. There was also one off-topic anonymous comment. This unit provides summaries of the most significant comments and EPA's responses. A complete set of comments and EPA's detailed responses can be found in the Response to Comments (RTC) document that is available in the docket for this rulemaking (Ref. 5).

Earthjustice, EDF, and all private citizens and the anonymous commenter expressed support for EPA's proposed addition of DINP to the TRI list. Additionally, Earthjustice urged EPA to work quickly to publish the rule as EPCRA does not require multiple toxicity endpoints for listing.

Comment: UPC disagreed with EPA's proposed listing. UPC claimed that adding DINP to the TRI chemicals list will cause companies to shift away from DINP, instead dealing with chemicals which have not been as well reviewed as DINP, and might be more toxic than DINP, and that listing DINP would create a barrier to international trade. They cited European Chemicals Agency 's (ECHA's) 2018 decision not to label DINP as a hazardous chemical as justification for why DINP would not satisfy EPCRA's requirements for listing.

EPA response: EPA respectfully disagrees with the commenter that DINP does not meet the TRI chemical listing criteria specified in EPCRA section 313(d)(2). Additionally, the fact that a chemical is not on a given organization's “hazardous chemical” list does not mean that the chemical fails to meet the EPCRA section 313(d)(2) listing criteria. The Agency's full rationale for listing the DINP category is detailed in the 2023 Technical Review of DINP (Ref. 2) and Response to Comments (Ref. 5).

Comment: ACC also disagreed with EPA's proposed listing of DINP. They asserted that EPA did not apply the correct legal standard because the Agency did not list DINP based on “cancer, birth defects, or serious or irreversible reproductive dysfunctions, neurological disorders, or heritable genetic mutations.” ACC also asserts that EPA improperly put the onus on the commenters to prove that DINP is not adverse to humans, rather than EPA showing that it is adverse to humans; and that EPA is assuming or “suspects” that DINP is a hazard, rather than having sufficient information that it does, in fact, meet the listing criteria.

EPA response: Section 313(d)(2) of EPCRA sets out the legal standard for adding new chemicals to the TRI list, and EPA applied this standard when deciding to add DINP. Commenters incorrectly describe this standard, which allows for listing based on sufficient evidence to establish any one of several criteria, including that the chemical is known to cause or can reasonably be anticipated to cause in humans “cancer or teratogenic effects, or serious or irreversible reproductive dysfunctions, neurological disorders, heritable genetic mutations, or other chronic health effects”. The Agency reasonably relied on hazards identified from animal studies which could plausibly be extrapolated to humans based on a weight of evidence (WoE) evaluation of health hazards posed by DINP in determining that DINP can reasonably be anticipated to cause one or more serious or irreversible chronic health effects in humans.

As documented in the 2023 Technical Review of DINP (Ref. 2), the evidence available to EPA is sufficient to establish that DINP can reasonably be anticipated to cause in humans serious or irreversible reproductive dysfunctions as well as other serious or irreversible chronic health effects in humans, specifically, developmental, kidney, and liver toxicity. This evidence includes evidence of developmental toxicity, such as: reduced pup weights, skeletal variations, and dilated renal pelvises; and also evidence of reproductive dysfunctions such that “gestational exposure to DINP has been shown to induce effects consistent with the spectrum of effects such as reduced fetal testicular testosterone, decreased AGD, increased male pup nipple retention, altered reproductive organ weight, testicular pathology, and a low incidence of reproductive tract malformation in some studies (such effects are sometimes generally referred to as `phthalate syndrome').” (Ref. 2). This evidence also includes evidence of other serious or irreversible chronic health effects; specifically, non-cancer liver and kidney toxicity.

Comment: ACC points to studies in non-human primates to argue that primates are much less sensitive to DINP than are rodents. ACC argues that the timeline of the primate studies was similar to that of rodent studies, so they should be considered.

EPA response: The commenter's argument does not consider the explanation that the short study duration (especially relative to the lifespan of the test species) accounts for the lack of treatment-related effects, and instead attributes the differential toxicity to differences in species sensitivity. ACC was referring to a 14-day study in macaques (Ref. 6) and a 90-day study in marmosets (Ref. 7). The marmoset study did show decreases in body weights and body weight gains in both sexes. However, the non-human primate studies were not further evaluated due to being considered insufficient in study design and duration to evaluate DINP for carcinogenicity as well as for potential reproductive and developmental effects.

Comment: ACC commented on EPA's proposal to list DINP based on cancer as an endpoint, and stated that the EPA could not list DINP on the TRI simply because it was on the California Prop 65 list. ACC further commented that certain animal tumors discussed in the 2022 Technical Review of DINP (Ref. 1) as evidence for listing DINP due to carcinogenicity (including alpha-2u-globulin-mediated kidney cancers in male rats, mononuclear cell leukemia (MNCL), and PPARα-mediated liver tumors) are not indicative of human hazard. The comment claimed that there is significant evidence to show that all three DINP-induced rodent tumors are specific to rodents and not relevant to human cancer.

EPA response: EPA's decision to list DINP on the TRI is based on EPA's analysis of the available data, and not, as the commenter appears to suggest, on a decision made by another regulatory body. Moreover, as explained in greater detail in the Response to Comments (Ref. 5), EPA has decided not to rely on a cancer endpoint for this action to add a DINP chemical category to the TRI chemical list.

As explained in greater detail in the 2023 Technical Review of DINP (Ref. 2), in this action EPA is adding DINP to the TRI chemical list based on toxicity data demonstrating that these chemicals can be reasonably anticipated to cause serious or irreversible reproductive dysfunctions and other serious or irreversible chronic human health effects, including developmental, liver, and kidney effects. EPA revised the 2022 Technical Review of DINP (Ref. 1) regarding the evaluation of MNCL and tumors in the liver and kidney, in addition to including a new section on “Tumors Observed in Other Organs” under the Conclusions on Carcinogenicity Section of the 2023 Technical Review of DINP (Ref. 2). This section provides a brief discussion of the data for pancreatic islet cell carcinomas, testicular interstitial (Leydig) cell carcinomas and uterine adenocarcinomas. EPA did not, however, base its decision to list DINP on these data.

Comment: ACC asserted that, “in addition to animal evidence, human evidence, where available, would be crucial to the EPA's evaluation, including the developmental endpoint for DINP. However, neither the EPA's Supplemental Notice nor the Revised Technical Review for DINP includes any of the growing epidemiological evidence”.

EPA response: The Agency acknowledges that the evidence of developmental hazard presented to support the listing of DINP on the TRI focused on the evidence in developmental toxicity and reproduction studies in laboratory animals. The Agency determined that this evidence is extensive and unambiguous in interpretation. EPA notes that the epidemiology data on developmental hazard, although pertinent, do not negate the importance of the animal data, especially given the extent of evidence provided by animal data. Further, inconsistent results make it difficult to draw a definitive conclusion on hazard concerns from epidemiological data on DINP. Therefore, EPA determined that the epidemiological studies are not required to inform the Agency's decision to list DINP on the TRI. EPA's discussion of the epidemiological data referenced by ACC in its comment is addressed further in the Response to Comment document (Ref. 5). Furthermore, the Agency does not consider the lack of presentation of epidemiological evidence to detract from the strength of evidence of both developmental and reproductive hazard posed by DINP represented in the animal studies.

Comment: Reduced pup weights were reversible or transient, inconsistently observed, not statistically significant, and did not cause any adverse effects in older rats, so they should not be considered “serious or irreversible” effects.

EPA response: EPA disagrees with the characterization of the body weight decreases as transient, which is typically interpreted in evaluation of toxicology studies as the effect being temporary in the presence of continued exposure. In the two major studies cited (both discussed in Waterman et al., 2000 (Ref. 8)), statistical significance was achieved at multiple timepoints. Particularly in the two-generation study (Ref. 8), the decreased F1 offspring body weights became more pronounced in statistical significance and in magnitude difference from controls, and occurred at lower doses as the post-natal period proceeded. The effects of DINP on body weight occurred in both sexes and across generations and generally increased in significance and magnitude with time; and importantly, occurred at lower doses in offspring compared to parents.

Regarding ACC's comment that reduced pup weight results are inconsistent, EPA acknowledges that in some studies with shorter exposure durations, longer term effects on growth may not be apparent. In the study by Clewell et al. (Ref. 9), pregnant rats were administered DINP in the diet from gestational day (GD) 12 through postnatal day (PND) 14. However, even with this shorter exposure duration, dams exhibited reduced body weight, body weight gain, and food consumption during gestation and lactation at 750 mg/kg/day. Offspring body weights of males were decreased at PND 14 at the high dose on PND 2 (↓12%) and dose-dependently at both the mid- and high-dose on PND 14 (↓10-27%) at termination of dosing. The fact that the male offspring body weights were not significantly decreased by PND 49-50 (↓4%; NS) with no exposure to DINP since PND 14 (~35 days) does not equate to transient decreases (those that occur with continued exposure).

Furthermore, an additional study showed that decreased body weights persisted after the treated period ended. Masutomi et al. (Ref. 10) evaluated developmental effects in the offspring of female Sprague-Dawley rats exposed to DINP in the diet at concentrations of 0, 400, 4,000, or 20,000 ppm from GD 15 to PND 10. Even though treatment ceased on PND 10, prepubertal body weights of offspring were still significantly decreased on PND 27. Importantly, the decreased body weight in male offspring occurred at a lower dose than affected maternal body weights, indicating heightened relative sensitivity of male offspring exposed in utero compared to parents. Finally, it is important to note that these decreases were substantial, with decreases of 18% in mid-dose males and 39-47% in high dose males and females, and were highly significant (p<0.01). This supporting evidence shows that adverse effects are seen in prepubertal rats born to exposed pregnant females; it can be reasonably expected that results would persist into adulthood.

In short, the decreases in body weight and weight gain in the animals in the reproduction and developmental toxicity studies on DINP are “serious,” in part, because they increase in magnitude and significance with time exposed and across generations and occur at lower doses in offspring than in parents.

Comment: ACC questioned EPA's use of skeletal effects and dilated renal pelvises as evidence of DINP toxicity to developmental health. ACC stated that the conclusions of the ECHA and Australia's National Industrial Chemicals Notification and Assessment Scheme (NICNAS) are that supernumerary ribs are common anomalies in rodents which can only be “indicative of slight developmental effects.” ACC asserted that animals in multi-generation studies thrived and there was no evidence of adverse effects related to these variations. ACC also asserted that the agency itself is unsure of the biological relevance of increased rib variations in rats. For the renal pelvises effects, ACC stated that the dilated renal pelvises reported in Waterman et al. (2000) (Ref. 8) and Hellwig et al. (1997) (Ref. 11) are transient, of doubtful biological and statistical significance, and occur only at maternally toxic doses.

EPA response: Supernumerary ribs are larger (longer) structures with distal cartilage present and are likely to be permanent, ultimately remaining as distinct ribs; whereas ossification sites are smaller (shorter) structures without distal cartilage and are likely to be transient.

The developmental variations seen in Waterman et al. (1999) (Ref. 12) include significantly increased incidences of rudimentary lumbar ribs at 500 and 1,000 mg/kg-day, compared to controls. Additionally, incidences of supernumerary cervical ribs were significantly increased at 1000 mg/kg-day, compared to controls. The authors noted that supernumerary lumbar ribs “have been associated with nonspecific maternal toxicity”; however, this does not preclude its relevance, and it is important to note that significantly increased incidences of rudimentary lumbar ribs were noted at a dose lower than that at which maternal toxicity was observed. Furthermore, no corroborating findings of delayed fetal ossification, which would suggest that fetal effects were secondary to maternal effects, were reported at the high dose in this study. ACC has taken the Agency's statement from the 2022 Technical Review of DINP (Ref. 1) out of context. The full statement was: “Therefore, although the biological significance of a statistically significant increase in rib variations is uncertain, the Agency believes that the dose-related response observed in the Waterman et al. (1999) (Ref. 12) study may represent growth alterations that are indicative of DINP's potential to disrupt normal developmental patterns and produce a developmental hazard.” The Agency reiterates its conclusion that DINP can reasonably be anticipated to be developmentally toxic to humans.

EPA acknowledges that the dilated renal pelvises observed in Hellwig et al. (1997) (Ref. 11) were consistently increased over controls only at the high dose of 1000 mg/kg-day. However, the fact that this fetal finding in this study was noted at a dose that was toxic to the maternal animals does not preclude its toxicological relevance to offspring. And it is important to note that, for DINP-3, increased dilated renal pelvises observed at 1000 mg/kg-day were accompanied in some instances by renal malformations ( e.g., hydroureter, agenesis or absence of kidney). Furthermore, in the developmental toxicity study in rats conducted by Waterman et al. (1999) (Ref. 12), fetal and litter incidences of dilated renal pelvis were statistically significant and dose-dependently increased in all treated groups, whereas maternal toxicity, as evidenced by decreased body weights and weight gains during treatment, was affected only at the high dose of 1000 mg/kg-day. EPA disagrees with the characterization that dilated renal pelvis is a “normal developmental phenomenon” (as stated by NICNAS), but acknowledges that the toxicological relevance is dependent upon the incidence and severity. Nevertheless, the commenters mischaracterized NICNAS's conclusion on these variations. The full statement from NICNAS reads: “These variations are relatively common in rodents; however, the induced frequencies (78% vs 25% control for rudimentary lumbar ribs, and 26% vs 0% control for dilated renal pelvises) were outside historical control ranges and thus interpreted as indicative of slight developmental effects.” (Ref. 13, emphases added). Therefore, NICNAS also interpreted the renal pelvis and additional lumbar ribs to be indicative of adverse effects of DINP.

To summarize, dilated renal pelvises incidences in these studies are treatment-related, and it remains to be seen whether the findings are reversible/transient because that depends on the severity of the effects. However, it is the Agency's determination that dilated renal pelvises, in addition to renal malformations, even at doses with observed maternal toxicity, are biologically significant, and contribute to the WoE for DINP as a developmental toxicant.

Comment: ACC asserted that DINP does not cause a serious or irreversible effect on anogenital distance (AGD) or nipple retention in animals, citing a lack of statistical significance in Clewell et al. (2013) (Ref. 14) for AGD and Gray et al. (2000) (Ref. 15) for nipple retention. ACC stated that these effects, if they occur, are only transient and do not persist into adulthood. Finally, ACC asserts that DINP is not associated with male reproductive malformations in humans.

EPA response: EPA acknowledges that there is some inconsistency in reporting of significant effects on AGD across available studies of DINP and that permanent, statistically significant reductions in AGD have not been reported in adult offspring following gestational exposure to DINP. However, reduced AGD in males is only one of many effects that make up phthalate syndrome (or androgen insufficiency syndrome). As described in EPA's 2023 Technical Review of DINP (Ref. 2), gestational exposure to DINP has been shown to induce effects consistent with the spectrum of effects that comprise phthalate syndrome ( e.g., reduced fetal testicular testosterone, decreased AGD, increased male pup nipple retention, altered reproductive organ weight, testicular pathology, and a low incidence of reproductive tract malformation in some studies). Therefore, EPA still considers a decrease in AGD to be a potential adverse and serious outcome of DINP exposure and a reflection of the suite of effects that comprise phthalate syndrome.

EPA also acknowledges that there is some inconsistency in reporting of nipple retention across available studies of DINP. In Gray et al. (2000) (Ref. 15), the finding of permanent nipples in DINP-treated rats was accompanied by several abnormalities in the testes, including testicular atrophy, epididymal agenesis with hypospermatogenesis, and scrotal fluid-filled testis devoid of spermatids. This syndrome may result from inhibition of fetal testis hormone production during sexual differentiation, a process that is critical in all mammals including humans. Furthermore, the finding of nipple retention was not exclusively noted in Gray et al. (2000) (Ref. 15). For example, Boberg et al. (2011) (Ref. 16) demonstrated a dose-dependent and statistically significant increase in the number of retained nipples in DINP-exposed (GD 7 to PND 19) male pups on PND 13 at 750 mg/kg-day (3.14) and 900 mg/kg-day (3.17) compared to controls (1.98), which ACC failed to mention when citing the findings in the study at PND 90.

In addition to the male reproductive malformations noted in the two studies by Gray et al. (2000 (Ref. 15), 2023 (Ref. 17)), EPA discussed the findings of ten additional studies in its 2023 Technical Review of DINP (Ref. 2) which support the WoE for serious adverse impacts on the male reproductive tract. Such effects include: decreased body weight at the onset of puberty; decreased weights of the testes, levator ani plus bulbocavernosus muscles (LABC), and seminal vesicles; decreased testosterone, percent motile sperm, and AGD; increased incidences of multinucleated gonocytes (MNGs) in testes, large Leydig cell aggregates, degeneration of stage XIV meiotic spermatocytes, vacuolar degeneration of Sertoli cells, and scattered cell debris in the epididymal ducts; and effects on male copulatory behavior (reduced number of mounts, intromissions, and ejaculations).

Phthalate syndrome may result from inhibition of fetal testis hormone production during sexual differentiation, a process that is critical in all mammals including humans. EPA concludes that humans can reasonably be anticipated to be affected if exposed to sufficient concentrations of DINP or its metabolites at critical stages of reproductive development.

Comment: ACC commented on EPA's identification of spongiosis hepatis as a treatment-related lesion in rats exposed to DINP, and the Agency's position that the occurrence is relevant to human health; more specifically, ACC asserted that the mere fact that a lesion is treatment-related in a rat does not mean it will occur in humans. ACC further stated that the effect did not occur in mice exposed to similar levels of DINP, and that it is not a serious or irreversible effect, even in rats, because EPA did not state whether spongiosis hepatis is linked to any other adverse pathological or toxicological process detrimental to the health of affected rats. ACC added that liver enzyme changes in studies appeared to be sporadic and not indicative of serious liver damage. ACC concluded that spongiosis hepatis is not relevant to human health.

Response: EPA disagrees with ACC's conclusion and maintains that the finding of spongiosis hepatis in rats has human relevance as one of multiple indicators of adverse outcomes to the liver post-DINP exposure. While the human relevance of spongiosis hepatis, in particular, is unclear, that does not preclude its relevance in a WoE evaluation of evidence of hepatotoxicity in the rat, and the Agency does not consider the lack of evidence of a direct human correlate of spongiosis hepatis to detract from the extrapolation of that evidence in animals to relevance to human health. The Agency references Lington et al. (1997) (Ref. 18) for the co-occurring findings of other histopathology effects in the liver due to DINP treatment including focal necrosis, hepatopathy associated with leukemia, and hepatocellular enlargement in both sexes, in addition to sinusoid ectasia in males. The Agency also references Moore et al. (1998a) (Ref. 19) and Bio/dynamics (1987) (Ref. 20) for co-occurring findings in the liver, including cytoplasmic eosinophilia, diffuse hepatocellular enlargement, and increased pigment in both sexes, and additionally individual cell degeneration/necrosis in the males. Moore et al. (1998b) (Ref. 21) also conducted a 2-year study in mice and found similar adverse treatment-related effects on the liver. In all these studies, increases in key indicator enzymes were also observed.

The Agency acknowledges that treatment-related effects on the liver are often along a continuum, with effects early on and at lower doses reflecting an adaptive response (often indicated by increased liver weights and/or hepatocellular hypertrophy) but progressing to an adverse response at prolonged or higher doses, characterized by adverse findings in clinical chemistry and histopathology. While induction of CYP450s as a metabolic activation response of the liver may be an adaptive response, increases in ALT are indicative of liver damage and inherently adverse, and the clinical interpretation of this finding is conserved across species, including humans. For certain enzymes ( e.g., ALT), increases, as well as various enzymatic activities when considered with other effects such as histopathology lesions, are adverse effects and support the conclusion that DINP induces serious chronic effects in the liver beyond liver enlargement. Thus, the Agency disagrees with ACC's assertion that the increases in liver weights and enzymes seen in these studies are an adaptive response or are non-serious in the total weight of evidence.

Comment: ACC commented that: (a) DINP does not cause and cannot reasonably be anticipated to cause rodent chronic progressive nephropathy (CPN) in human kidneys, as no human analog exists; (b) while EPA may “speculate,” per ACC's characterization, that chemicals that cause CPN in rodents may cause other kidney effects in humans, such “speculation” is not appropriate for a TRI listing; and (c) even the EPA's “speculation” is unlikely to be supported, as there is minimal evidence that DINP is associated with any kidney disease in humans. ACC further points to the lack of adverse effects seen in primate studies as evidence that DINP is not relevant to human health.

EPA response: Although the mechanism of DINP-induced kidney toxicity may not be clear, the kidneys are clearly a target of DINP-induced toxicity which can reasonably be anticipated to cause serious or irreversible chronic health effects in humans, as evidenced by increases in absolute and relative kidney weights, clinical chemistry ( e.g., increased blood urea nitrogen), urinalysis changes, and findings in gross pathology ( e.g., granular pitted/rough kidneys), and histopathology ( e.g., reduction in the tubular space and oedema of epithelial cells in the glomeruli, a loss of loop points in the glomerular capillaries, increased granular casts and regenerative/basophilic tubules) in rats and mice. EPA disagrees with ACC's conclusion that the changes in kidney weights in rats are not relevant to human kidney toxicity, and asserts that the lack of an effect in the primate studies ACC mentioned is plausibly related to the shorter duration of dosing relative to the life span of the animal instead of indicating a lack of relevance to humans. (See the “Generally: EPA has Failed to Apply the Correct Legal Standard in this Case” section.) Given that increased kidney weight appears as a consistent effect among other kidney injuries following DINP exposure, EPA believes it to be relevant in the WoE supporting DINP kidney toxicity. EPA acknowledges that, in a letter to the U.S. EPA IRIS Program (NIEHS 2019) (Ref. 22), U.S. NTP concluded that the “morphological spectrum of CPN have no analog in the human kidney and that CPN is distinct entity in the rat (Hard et al., 2009) (Ref. 23).” However, NTP also acknowledged that “The etiology of CPN is unknown and represents a complex disease process in rats. Given the fact that there is no definitive pathogenesis for this multifactorial disease process, it cannot be fully ruled out that chemicals which exacerbate CPN in rats may have the potential to exacerbate disease processes in the human kidney.” Subsequently, the EPA IRIS Program in its toxicological reviews of tert-Butanol (EPA 2021a) (Ref. 24) and ethyl tertiary butyl ether (EPA 2021b) (Ref. 25) (chemicals which cause CPN in male and female rats) concluded that “a chemical that exacerbates CPN in rats could also exacerbate disease processes in the human kidney” and that other effects in the kidney were observed that were not confounded by alpha 2u-globulin related processes, and kidney toxicity was selected as the basis of the oral noncancer reference doses that were derived. Similarly, for DINP, available studies demonstrate a spectrum of effects on the kidney. Given the WoE when considering the other effects involving the kidney, and EPA's position, based on the Agency's technical expertise, that chemicals which exacerbate CPN in rodents could also exacerbate disease processes in the human kidney, DINP can reasonably be anticipated to cause serious and/or irreversible harm to the kidney based on the literature reviewed.

Furthermore, the EPA disagrees with ACC's assertion that the kidney toxicity seen in female mice is irrelevant to human health. Although α-2u-globulin MOA is male rat-specific and has been shown not to be relevant to humans, the MOA for kidney toxicity for female rats and male and female mice remains unclear and so in order to be protective of human health, EPA maintains that CPN is relevant to human health and contributes to the WoE for kidney toxicity for this non-cancer endpoint. A study by Ma et al. (Ref. 26) found that oxidative stress may be involved in the hepatic and renal toxicities associated with DINP exposure. In order to be protective of human health, the EPA maintains that oxidative stress-related mechanism are relevant to human health. EPA would like to direct ACC's attention to the “Conclusions on Chronic Non-cancer Toxicity” section 2.5.6.2 on “Kidney Effects” in the 2023 Technical Review of DINP (Ref. 2) for further details.

Comment: ACC argued that due to its physico/chemical properties, community exposure to DINP via environmental release is negligible.

EPA response: As EPA has previously stated, including in the supplemental proposal for this rulemaking (87 FR 48128), it is not appropriate to consider exposure for chemicals that are moderately high to highly toxic based on a hazard assessment when determining if a chemical should be added for chronic human health effects pursuant to EPCRA section 313(d)(2)(B) (see 59 FR 61440-61442). EPA concludes that DINP can reasonably be anticipated to cause serious or irreversible chronic human health effects at moderately low to low doses including serious or irreversible reproductive dysfunctions as well as other serious or irreversible chronic health effects in humans, specifically, developmental, kidney, and liver toxicity. The data for DINP demonstrates that DINP has moderately high to high human health toxicity. For listings pursuant to EPCRA section 313(d)(2)(A), EPA must consider whether “chemical is known to cause or can reasonably be anticipated to cause significant adverse acute human health effects at concentration levels that are reasonably likely to exist beyond facility site boundaries as a result of continuous, or frequently recurring, releases.” However, even pursuant to such listings, the Agency need not confirm that communities are actually exposed to the given chemical, but rather that concentration levels of concern are reasonably likely to exist beyond a facility's boundaries as a result of releases. Further, listings based on EPCRA section 313(d)(2)(B) (as well as EPCRA section 313(d)(2)(C)) do not require an exposure assessment, but rather are based on hazard alone.

Therefore, in accordance with EPA's standard policy on the use of exposure assessments (see November 30, 1994 (59 FR 61432, FRL-4922-2), an exposure assessment is neither necessary nor appropriate for determining whether DINP meets the criteria of EPCRA section 313(d)(2)(B).

Additionally, EPA notes that EPCRA indicates that TRI reporting forms are intended to provide information to governments and the public to inform persons about releases of toxic chemicals to the environment, assist in the conduct of research and data gathering, and to aid in the development of regulations and other similar purposes (see EPCRA section 313(h)). Accordingly, even if releases are very small, the data reported is still useful. For example, such reporting might indicate that a toxic chemical being used in the community is not being released at levels of concern, which would be reassuring to residents. Further, how the public or any particular entity may make use of TRI data on a particular chemical need not factor into whether or not that chemical is on the TRI list of chemicals.

EPA is finalizing the addition of a DINP category to the EPCRA section 313 list of toxic chemicals. Based on EPA's review of the available toxicity data, EPA has determined that these chemicals can be reasonably anticipated to cause serious or irreversible reproductive dysfunctions as well as serious or irreversible chronic human health effects in humans, including developmental, kidney, and liver toxicity. Therefore, EPA has determined that the evidence is sufficient for listing the DINP category on the EPCRA section 313 toxic chemicals list pursuant to EPCRA section 313(d)(2)(B).

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

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

This action is not a significant regulatory action as defined in Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by Executive Order 14094 (88 FR 21879, April 11, 2023), and was therefore not subject to a requirement for Executive Order 12866 review.

This action does not impose any new information collection burden under the PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR 1320.3(b). OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control numbers 2070-0212 and 2050-0078.

Currently, the facilities subject to the reporting requirements under EPCRA section 313 and PPA section 6607 may use either EPA Toxic Chemicals Release Inventory Form R (EPA Form 9350-1), or EPA Toxic Chemicals Release Inventory Form A (EPA Form 9350-2). The Form R must be completed if a facility manufactures, processes, or otherwise uses any listed chemical above threshold quantities and meets certain other criteria. For the Form A, EPA established an alternative threshold for facilities with low annual reportable amounts of a listed toxic chemical. A facility that meets the appropriate reporting thresholds, but estimates that the total annual reportable amount of the chemical does not exceed 500 pounds per year, can take advantage of an alternative manufacture, process, or otherwise use threshold of 1 million pounds per year of the chemical, provided that certain conditions are met, and submit the Form A instead of the Form R. In addition, respondents may designate the specific chemical identity of a substance as a trade secret pursuant to EPCRA section 322, 42 U.S.C. 11042, 40 CFR part 350.

OMB has approved the reporting and recordkeeping requirements related to Forms A and R, supplier notification, and petitions under OMB Control number 2070-0212 (EPA Information Collection Request (ICR) No. 2613.02) and those related to trade secret designations under OMB Control 2050-0078 (EPA ICR No. 1428). As provided in 5 CFR 1320.5(b) and 1320.6(a), an Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers relevant to EPA's regulations are listed in 40 CFR part 9 and displayed on the information collection instruments ( e.g., forms, instructions).

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. The small entities subject to the requirements of this action are small manufacturing facilities. The Agency has determined that no small governments or small organizations are expected to be affected by this action; and that of the 198 to 396 entities estimated to be impacted by this action, 181 to 365 are small businesses. All small businesses affected by this action are estimated to incur annualized cost impacts of less than 1%. Thus, this action is not expected to have a significant adverse economic impact on a substantial number of small entities. A more detailed analysis of the impacts on small entities is located in EPA's economic analysis (Ref. 4).

This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments and EPA did not identify any small governments that would be impacted by this action. EPA's economic analysis indicates that the total industry cost of this action is estimated to be $968,546 to $1,935,041 in the first year of reporting and $461,212 to $921,448 in subsequent years (Ref. 4).

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

This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have substantial direct effects on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. This action relates to toxic chemical reporting under EPCRA section 313, which primarily affects private sector facilities. Thus, Executive Order 13175 does not apply to this action.

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

Although this action does not concern an environmental health or safety risk, the data collected as a result of this action will provide information about releases to the environment that could be used to inform the public on potential exposures to toxic chemical releases, pursuant to the right-to-know principles. EPA also believes that the information obtained as a result of this action could be used by government agencies, researchers, and others to identify potential problems, set priorities, and take appropriate steps to reduce any potential exposures and related human health or environmental risks identified as a result of increased knowledge of exposures to DINP.

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

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

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

EPA believes that it is not practicable to assess whether the human health or environmental conditions that exist prior to this action result in disproportionate and adverse effects on people of color, low-income populations and/or indigenous peoples. This action adds a chemical category to the EPCRA section 313 reporting requirements; it does not directly address any human health or environmental risks and does not affect the level of protection provided to human health or the environment. However, EPA believes that the information obtained as a result of this action could be used by the public (including people of color, low-income populations and/or Indigenous peoples) to inform their behavior as it relates to sources of DINP exposure, or by government agencies and others to identify potential problems, set priorities, and take appropriate steps to reduce those exposures, as well as assess any potential human health or environmental risks.

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

Therefore, for the reasons set forth in the preamble, EPA is amending 40 CFR part 372 as follows:

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

The 2023 total allowable catch (TAC) of Pacific ocean perch in the West Yakutat District of the GOA is 1,370 metric tons (mt) as established by the final 2023 and 2024 harvest specifications for groundfish of the GOA (88 FR 13228, March 2, 2023).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2023 TAC of Pacific ocean perch in the West Yakutat District of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 1,270 mt, and is setting aside the remaining 100 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific ocean perch in the West Yakutat District of the GOA. While this closure is effective the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

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

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing of Pacific ocean perch in the West Yakutat district of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of July 10, 2023.

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

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

The 2023 total allowable catch (TAC) of dusky rockfish in the West Yakutat District of the GOA is 90 metric tons (mt) as established by the final 2023 and 2024 harvest specifications for groundfish of the GOA (88 FR 13238, March 2, 2023).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2023 TAC of dusky rockfish in the West Yakutat District of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 60 mt, and is setting aside the remaining 30 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for dusky rockfish in the West Yakutat District of the GOA. While this closure is effective, the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

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

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion, and would delay the closure of directed fishing of dusky rockfish in the West Yakutat district of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of July 10, 2023.

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