This action, pursuant to 5 U.S.C. 553, amends regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This rule is issued under Marketing Order No. 927, as amended (7 CFR part 927), regulating the handling of pears grown in Oregon and Washington. Part 927 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of growers and handlers of pears operating within the production area, and a public member.

The Agricultural Marketing Service (AMS) is issuing this rule in conformance with Executive Orders 12866 and 13563. Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review.

This rule has been reviewed under Executive Order 13175—Consultation and Coordination with Indian Tribal Governments, which requires agencies to consider whether their rulemaking actions would have tribal implications. AMS has determined this rule is unlikely to have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the Order now in effect, Oregon and Washington fresh pear handlers are subject to assessments. Funds to administer the Order are derived from such assessments. It is intended that the assessment rate be applicable to all assessable fresh pears for the 2021-22 fiscal period, and continue unless amended, suspended, or terminated.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with Department of Agriculture (USDA) a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed no later than 20 days after the date of the entry of the ruling.

The Order authorizes the Committee, with the approval of AMS, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. Members are familiar with the Committee's needs and with the costs of goods and services in their local area, and are in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

This final rule increases the assessment rate from $0.463 per 44-pound standard box or equivalent of fresh “summer/fall” and “winter” pears, the rate that was established for the 2018-19 and subsequent fiscal periods, to $0.468 per 44-pound standard box or equivalent of assessable fresh “summer/fall” pears and “winter” pears for the 2021-22 and subsequent fiscal periods.

For the 2018-19 and subsequent fiscal periods, the Committee recommended, and AMS approved, an assessment rate of $0.463 per 44-pound standard box or equivalent of assessable fresh “summer/fall” pears and “winter” pears. That assessment rate continued in effect from fiscal period to fiscal period unless modified, suspended, or terminated by AMS upon recommendation and information submitted by the Committee or other information available to AMS.

The Committee met on June 3, 2021, and unanimously recommended expenditures of $8,472,263 and an assessment rate of $0.468 per 44-pound standard box or equivalent of assessable fresh “summer/fall” pears and “winter” pears handled for the 2021-22 and subsequent fiscal periods. In comparison, last year's budgeted expenditures were $8,901,114. The assessment rate of $0.468 is $0.005 higher than the rate previously in effect. The Committee recommended increasing the assessment rate due to a smaller estimated 2021 crop and to provide adequate income, along with reserve funds and interest income, to cover all of the Committee's budgeted expenses for the 2021-22 fiscal period.

Major expenditures recommended by the Committee for the 2021-22 fiscal period include $391,047 for contracted administration, $159,540 for industry development, $964,476 for production research and market development, $27,200 for miscellaneous expenses, and $6,930,000 for promotion and paid advertising for “summer/fall” and “winter” varieties of fresh pears. Budgeted expenses for these items for the 2020-21 fiscal period were $388,520, $172,000, $997,394, $28,200, and $7,315,000, respectively.

The Committee derived the recommended assessment rate by considering anticipated expenses, and an estimated 2021 crop of 18,000,000 44-pound standard boxes or equivalent of assessable fresh “summer/fall” pears and “winter” pears. Income derived from handler assessments, calculated at $8,424,000 (18,000,000 standard boxes or equivalent multiplied by $0.468 assessment rate), along with reserve funds and interest income ($48,263), will be adequate to cover budgeted expenses of $8,472,263.

The assessment rate established in this rule will continue in effect indefinitely unless modified, suspended, or terminated by AMS upon recommendation and information submitted by the Committee or other available information.

Although this assessment rate will be in effect for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or AMS. Committee meetings are open to the public and interested persons may express their views at these meetings. AMS will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Committee's 2021-22 fiscal period budget, and those for subsequent fiscal periods, will be reviewed and, as appropriate, approved by AMS.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order to ensure that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 708 growers of fresh pears in the production area and 27 handlers subject to the regulation under the Order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $1,000,000, and small agricultural service firms have been defined as those whose annual receipts are less than $30,000,000 (13 CFR 121.201).

According to the National Agricultural Statistics Service, the 2020 average grower price received for fresh pears produced in Oregon and Washington was $11.39 per standard 44-pound box or equivalent. Committee data indicates total production was 16,290,225 44-pound standard boxes or equivalent in the 2019-20 fiscal period. The total 2019-20 fiscal period value of assessable fresh “summer/fall” and “winter” pears grown in Oregon and Washington was $185,545,663 (16,290,225 44-pound standard boxes or equivalent times $11.39 per box equals $185,545,663). Dividing the crop value by the estimated number of growers (708) yields an estimated average receipt per grower of $262,070.

According to AMS Market News data, the reported average terminal price for 2020 Oregon and Washington fresh pears was $34.87 per 44-pound standard box or equivalent (data reported in 4/5 bushel). Multiplying the Committee-reported 2019-20 Oregon and Washington total production of 16,290,225 44-pound standard boxes or equivalent by the estimated average price per box or equivalent of $34.87 equals $568,040,146. Dividing this figure by 27 regulated handlers yields estimated average annual handler receipts of $21,038,524. Therefore, using the above data, the majority of growers and handlers of Oregon and Washington fresh pears may be classified as small entities.

As noted above, the average price received by growers in the 2019-20 crop year was $11.39 per 44-pound standard box or equivalent of assessable fresh “summer/fall” pears and “winter” pears. Given the Committee-estimated production of 18,000,000 44-pound standard boxes or equivalent of assessable fresh pears for the 2021-22 crop year, the total grower revenue is estimated to be $205,020,000. The total assessment revenue is expected to be $8,424,000 (18,000,000 boxes multiplied by $0.468 per box). Thus, the total assessment revenue compared to total grower revenue is 4.1 percent ($8,424,000 divided by $205,020,000).

This rule increases the assessment rate collected from handlers for the 2021-22 and subsequent fiscal periods from $0.463 to $0.468 per 44-pound standard box or equivalent of assessable fresh “summer/fall” pears and “winter” pears. The Committee unanimously recommended 2021-22 fiscal period expenditures of $8,472,263 and an assessment rate of $0.468 per 44-pound standard box or equivalent of assessable fresh “summer/fall” pears and “winter” pears handled. The assessment rate of $0.468 per 44-pound standard box or equivalent of assessable fresh “summer/fall” pears and “winter” pears is $0.005 higher than the rate previously in effect. The volume of assessable fresh “summer/fall” pears and “winter” pears in the production area for the 2021-22 fiscal period is estimated to be 18,000,000 44-pound standard boxes or equivalent. Thus, the $0.468 per 44-pound standard box or equivalent of assessable fresh “summer/fall” pears and “winter” pears assessment rate should provide $8,424,000 in assessment income (18,000,000 multiplied by $0.468). Income derived from handler assessments, along with reserve funds and interest income, will be adequate to cover budgeted expenses for the 2021-22 fiscal period.

Major expenditures recommended by the Committee for the 2021-22 fiscal period include $391,047 for contracted administration, $159,540 for industry development, $964,476 for production research and market development, $27,200 for miscellaneous expenses, and $6,930,000 for promotion and paid advertising for “summer/fall” and “winter” varieties of fresh pears. Budgeted expenses for these items for the 2020-21 fiscal period were $388,520, $172,000, $997,394, $28,200, and $7,315,000, respectively.

The Committee recommended increasing the assessment rate due to a smaller crop and to provide adequate income, along with reserve funds and interest income, to cover the Committee's budgeted expenses for the 2021-22 fiscal period. Prior to arriving at this budget and assessment rate recommendation, the Committee discussed various alternatives, including maintaining the previous assessment rate and increasing the assessment rate by a different amount. However, the Committee determined that the recommended assessment rate, along with reserve funds and interest income, will adequately fund budgeted expenses.

This rule increases the assessment obligation imposed on handlers. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to growers. However, these costs are expected to be offset by the benefits derived by the operation of the Order.

The Committee's meeting was widely publicized throughout the Oregon and Washington pear industry. All interested persons were invited to attend the meeting and encouraged to participate in Committee deliberations on all issues. Like all Committee meetings, the June 3, 2021, meeting was a public meeting, and all entities, both large and small, were able to express views on this issue. Finally, interested persons were invited to submit comments on this rule, including the regulatory and information collection impacts of this action on small businesses.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0189, Fruit Crops. No changes in those requirements will be necessary as a result of this rule. Should any changes become necessary, they would be submitted to OMB for approval.

This rule will not impose any additional reporting or recordkeeping requirements on either small or large Oregon and Washington pear handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

AMS is committed to complying 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.

AMS has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.

A proposed rule concerning this action was published in the Federal Register on November 19, 2021 (86 FR 64830). Copies of the proposed rule were also mailed or sent via email to all fresh pear handlers. A copy of the proposed rule was made available through internet by AMS and Office of the Federal Register. A 30-day comment period ending December 20, 2021, was provided for interested persons to respond to the proposal. One comment was received in support of the action. Accordingly, no changes have been made to the rule as proposed.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: https://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Richard Lower at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant material presented, including the information and recommendation submitted by the Committee and other available information, it is hereby found that this rule will tend to effectuate the declared policy of the Act.

For the reasons set forth in the preamble, the Agricultural Marketing Service amends 7 CFR part 927 as follows:

Pursuant to section 217 of the Immigration and Nationality Act (INA), 8 U.S.C. 1187, the Secretary of Homeland Security, in consultation with the Secretary of State, may designate countries for participation in the Visa Waiver Program (VWP) if certain requirements are met. Eligible citizens and nationals of VWP countries  1 may apply for admission to the United States at a U.S. port of entry as nonimmigrant visitors for a period of ninety (90) days or less for business or pleasure without first obtaining a nonimmigrant visa, provided that they are otherwise eligible for admission under applicable statutory and regulatory requirements. Other nonimmigrant visitors must obtain a visa from a U.S. embassy or consulate and generally must undergo an interview by consular officials overseas in advance of travel to the United States.

On August 3, 2007, the President signed into law the Implementing Recommendations of the 9/11 Commission Act of 2007 (9/11 Act), Public Law 110-53. Section 711 of the 9/11 Act required the Secretary of Homeland Security, in consultation with the Secretary of State, to develop and implement a fully automated electronic travel authorization system to collect biographical and other information as the Secretary of Homeland Security determines necessary to evaluate, in advance of travel, the eligibility of the applicant to travel to the United States under the VWP, and whether such travel poses a law enforcement or security risk. 2

On June 9, 2008, DHS published an interim final rule in the Federal Register (73 FR 32440) announcing the creation of the ESTA program for nonimmigrant visitors traveling to the United States by air or sea under the VWP, and regulations have since been codified in the Code of Federal Regulations (CFR), at 8 CFR 217.5. ESTA provided for an automated collection of the information required on the Form I-94W, Nonimmigrant Visa Waiver Arrival/Departure paper form (Form I-94W), in advance of travel. ESTA is intended to fulfill the statutory requirements described in section 711 of the 9/11 Act.

On November 13, 2008, DHS published a notice in the Federal Register (73 FR 67354) announcing that the use of ESTA would be mandatory for all VWP travelers traveling to the United States seeking admission at air and sea ports of entry beginning January 12, 2009. Since that date, VWP travelers have been required to receive travel authorization through ESTA prior to boarding a conveyance destined for an air or sea port of entry in the United States. Travelers unable to receive authorization through ESTA to travel under the VWP may still apply for a visa to travel to the United States. 3

There have been several laws enacted that include provisions regarding ESTA fees, which have been incorporated into the DHS regulations. The relevant statutes and prior DHS rules are described below. However, some recent statutory changes have not yet been incorporated into the DHS regulations. This rule incorporates those changes.

On March 4, 2010, the United States Capitol Police Administrative Technical Corrections Act of 2009, Public Law 111-145, was enacted. Section 9 of this law, the Travel Promotion Act of 2009 (TPA), mandated that the Secretary of Homeland Security establish a fee for the use of ESTA and begin assessing and collecting the fee no later than six months after enactment. 4 The TPA provided that the initial fee consists of the sum of “$10 per travel authorization” (travel promotion fee) to fund the newly authorized Corporation for Travel Promotion plus “an amount that will at least ensure recovery of the full costs of providing and administering the System, as determined by the Secretary” (known as the “operational fee” or the “processing charge”). 5 The TPA authorized collection of the $10 travel promotion fee through September 30, 2014. On July 2, 2010, the Homebuyer Assistance and Improvement Act of 2010, Public Law 111-198 at §  5, amended the TPA by extending the sunset provision of the travel promotion fee and authorizing the Secretary to collect this fee through September 30, 2015.

On August 9, 2010, DHS published an interim final rule in the Federal Register (75 FR 47701) announcing that, beginning September 8, 2010, a $4 operational fee would be charged to each ESTA applicant to ensure recovery of the full costs of providing and administering the system in addition to the $10 travel promotion fee that would be charged to each applicant receiving a travel authorization through September 30, 2015. Accordingly, the regulations at 8 CFR 217.5(h) were amended to provide that until September 30, 2015, the fee for an approved ESTA was $14, the sum of the $10 travel promotion fee and the $4 operational fee, and that beginning October 1, 2015, and after the sunset of the travel promotion fee, the fee for using ESTA would be just the operational fee of $4.

On December 16, 2014, section 605 of the Travel Promotion, Enhancement, and Modernization Act of 2014, Public Law 113-235, further extended the sunset provision of the travel promotion fee through September 30, 2020. It did not make any changes to the operational fee and CBP continues to collect that fee. In contrast to the travel promotion fee, which is set by Congress, the operational fee does not include a sunset provision or a statutory amount. The Secretary of Homeland Security has discretion to determine the operational fee amount pursuant to the TPA. CBP will reassess the $4 operational fee on a regular basis to ensure that it is set at a level to fully recover ESTA operating costs. Any changes to this operational fee with be done through a subsequent rulemaking.

On June 8, 2015, DHS published a final rule in the Federal Register (80 FR 32267) finalizing the June 9, 2008 interim final rule regarding the ESTA program and the August 9, 2010 interim final rule regarding the ESTA fee for nonimmigrant visitors traveling to the United States by air or sea under the VWP. Due to oversight, 8 CFR 217.5(h)(1) was not appropriately amended to provide the sunset date of September 30, 2020. Nonetheless, in accordance with section 217(h)(3)(B) of the Immigration and Nationality Act, 8 U.S.C. 1187(h)(3)(B), CBP continued to collect the $10 travel promotion fee.

On February 9, 2018, section 30203(a) of the Bipartisan Budget Act of 2018, Public Law 115-123, extended the sunset provision of the travel promotion fee through September 30, 2027.

On December 20, 2019, section 806 of the Further Consolidated Appropriations Act of 2020, Public Law 116-94, increased the travel promotion fee from $10 to $17. As a result of this provision, the ESTA fee, which includes both the travel promotion fee and the $4 operational fee, was increased to $21. CBP will begin collecting the new fee following the effective date of this rule. Pursuant to the Bipartisan Budget Act of 2018, this is the ESTA fee through September 30, 2027. Beginning on October 1, 2027, the ESTA fee will be $4. Pursuant to the TPA, the Secretary of Homeland Security has discretion to determine the operational fee amount. CBP will reassess the $4 operational fee on a regular basis to ensure that it is set at a level to fully recover ESTA operating costs. Any changes to this operational fee will be done through a separate rulemaking.

This rule updates the ESTA fee regulations to incorporate the most recent statutory provisions. To incorporate the new sunset provision for the travel promotion fee contained in section 30203(a) of the Bipartisan Budget Act of 2018, Public Law 115-123, this document amends 8 CFR 217.5(h)(1) by replacing “September 30, 2015” with “September 30, 2027”. To reflect the fact that, after September 30, 2027, the only ESTA fee will be the operational fee, this document amends 8 CFR 217.5(h)(2) by replacing “October 1, 2020” with “October 1, 2027”.

To implement the new travel promotion fee amount as set forth in section 806 of the Further Consolidated Appropriations Act of 2020, Public Law 116-94, this document amends 8 CFR 217.5(h)(1) by replacing the amount “$14.00” with “$21” and replacing the amount “$10” with “$17”. Additionally, this document removes extraneous decimal points and zeros after the references to “$4” throughout section 217.5(h).

The Administrative Procedure Act (APA) requirements in 5 U.S.C. 553 govern agency rulemaking procedures. Section 553(b) of the APA generally requires notice and public comment before issuance of a final rule. In addition, section 553(d) of the APA requires that a final rule have a 30-day delayed effective date. The APA, however, provides exceptions from the prior notice and public comment requirement and the delayed effective date requirements, when an agency for good cause finds that such procedures are “impracticable, unnecessary, or contrary to the public interest.” See 5 U.S.C. 553(b)(3)(B), (d)(3). Prior notice and comment is “unnecessary” when, “so far as the public is concerned,” the regulatory change is minor or merely technical. 6 Prior notice and comment has also been deemed “unnecessary” when there is no need to allow “affected parties an opportunity to participate in agency decision making early in the process, when the agency is more likely to consider alternative ideas,”  7 and where Congress requires an agency to perform a non-discretionary act, and where no extent of notice or commentary could have altered the obligation of the agency. 8 Additionally, courts have held that when there is a Congressionally approved extension to a program, further delay in implementing that program contravenes the program's purpose. 9

In this case, CBP finds that good cause exists for dispensing with prior notice and public procedure as unnecessary because the amendments to the regulations are simply conforming amendments to reflect statutory changes and a non-substantive administrative change regarding how the $4 fee is referenced in the regulations. Specifically, the amendments in this document are necessary to reflect the changes to the sunset provision regarding the travel promotion fee in the Bipartisan Budget Act of 2018 and to reflect the change to the travel promotion fee amount in the Further Consolidated Appropriations Act of 2020. CBP has no discretion in raising the fee.

For the same reasons, CBP finds that good cause exists for dispensing with the requirement for a delayed effective date as provided in 5 U.S.C. 553(d)(3).

Executive Orders 13563 and 12866 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action” that is economically significant under section 3(f)(1) of Executive Order 12866 as it results in transfers of over $100 million in a given year. Accordingly, OMB has reviewed this regulation.

The ESTA program pertains to nonimmigrant visitors traveling to the United States by air or sea under the Visa Waiver Program. ESTA provides for an automated collection of information from these travelers in advance of travel. Under the current regulations, the ESTA fee is $14 for an approved ESTA and consists of both a $10 travel promotion fee and a $4 operational fee. The Bipartisan Budget Act of 2018 extended the sunset provision for the travel promotion fee to 2027, and the Further Consolidated Appropriations Act of 2020 increased the travel promotion fee from $10 to $17. As a result of these statutory changes, the total fee for an approved ESTA has increased from $14 to $21. This final rule makes conforming amendments to DHS regulations to reflect the increase and extension of the travel promotion fee. CBP will begin collecting the new fee following the effective date of this rule. In accordance with the statutory changes, CBP could collect the new $17 fee even if this regulation were not promulgated. This rule is being promulgated for consistency between the statute and the regulations and to minimize the confusion any inconsistency would cause. Although the effects of the fee increase are not a result of this rule, but rather a result of the statutory changes, we analyze the effects here to inform the public of the effect of this fee increase.

The travel promotion fee is collected by CBP, but the fee revenue is not kept by CBP or DHS. Instead, up to $100 million of fee revenue goes to the Travel Promotion Fund, which is made available to the Corporation for Travel Promotion (subject to a matching requirement) to carry out its functions. Any remaining fee revenue is retained by the general fund of the Treasury. As annual collections are already over $100 million before the increase in the fee, all of the additional revenue generated by this fee increase will be retained by the general fund of the Treasury. As the $7 fee increase is relatively small compared to costs involved to travel to the United States, CBP anticipates that the fee increase will not adversely affect travel to the United States.

Table 1 shows the number of approved ESTA applications from fiscal year (FY) 2016 to 2021. Prior to the COVID pandemic, the average annual number of approved ESTA applications was approximately 15 million. After FY 2019, travel decreased substantially, and we expect that travel will remain lower through FY 2022, though forecasting travel coming out of a pandemic is difficult. For the purposes of this analysis, we project travel returning to normal in FY 2022. To the extent that it takes longer than that, the effects of the fee change will be lower.

In the absence of any publicly available forecast for post-pandemic travel, CBP uses an ordinary least squares (OLS) linear trend based on pre-pandemic data to forecast future approved ESTA applications once ESTA travel returns to pre-pandemic levels. Table 2 shows the forecasted future approved applications until FY 2027. 10

Using the forecast and applying the proposed $7 increase would result in the following forecast of additional revenue from the travel promotion fee. As shown in Table 3, the corresponding revenue forecasted is $108 million in FY 2022 to approximately $115 million in FY 2027. As this fee is not tied to the costs of the services provided by ESTA, this effect is not a cost but rather a transfer  11 of funds from one party to another within society. In this case, it is a transfer from ESTA travelers to the U.S. Government.

Table 4 presents the estimated discounted future revenue that would result from the fee increase of $7. The estimated travel promotion fee revenue is discounted at both 3-percent and 7-percent. The total revenue generated from the fee increase over the six-year period of analysis from fiscal year 2022 to 2027 is expected to be $603,619,432 after applying a 3-percent discount rate, and $539,391,804 using a 7-percent discount rate. The annualized amount using a 3-percent discount rate is $111,426,638, and $111,273,973 using a 7-percent discount rate.

On July 28, 2021, FSIS proposed to remove the certified pet food provisions (9 CFR part 355) from the regulations because they are outdated and no companies use the voluntary service. In addition, because FDA also maintains regulations concerning pet food, the FSIS regulations have led to industry and consumer confusion (86 FR 40369).

As FSIS explained in the proposed rule, under the Federal Food, Drug, and Cosmetic Act (FFDCA), FDA is responsible for ensuring that pet food is safe for animals, produced under sanitary conditions, contains no harmful substances, and is truthfully labeled. FDA has had authority to regulate pet food since the FFDCA was passed in 1938. FDA does not charge pet food producers a fee for any FDA activities related to pet food. Individual States also regulate and inspect pet food, which also minimizes the need for FSIS's program.

Since 1958, under the Agricultural Marketing Act (7 U.S.C. 1622(h)), USDA also provided for the voluntary certification of pet food as having been produced under sanitary conditions and meeting compositional and labeling requirements. Under the regulations at 9 CFR part 355, participating facilities pay for this certification. The regulations governing FSIS certification services for pet food have not been substantively amended since the 1960s; therefore, the requirements are outdated ( e.g., requirements regarding pet food ingredients and the submission of firm blueprints). Additionally, the regulations allow for certification of only certain categories of pet food ( i.e., canned or semi-moist maintenance food, canned or fresh frozen certified supplemental animal foods, and canned certified variety meats). Many types of pet foods that were developed in the last few decades are thus not eligible for FSIS certification ( e.g., pet jerky, pet treats, pet rawhides, raw pet food, freeze-dried pet food, and prescription pet food). Likely for these reasons, no firms are participating in the FSIS certified pet food program.

After considering the comments received on the proposed rule, discussed below, FSIS is finalizing the proposed rule without changes.

FSIS received 149 comments on the proposed rule from individuals and pet food industry groups. Below is a summary of the comments received and FSIS' responses.

Comments: FSIS received comments from several individuals and two industry groups that supported the removal of 9 CFR part 355. These commenters agreed that FSIS' voluntary pet food certification program is outdated and that having pet food under the jurisdiction of a single Federal agency will eliminate confusion by pet food consumers and manufacturers.

FSIS also received comments from pet food buyers and an industry group stating that FSIS should update its certified pet food program instead of removing it. The commenters suggested rewriting the regulation to remove obsolete references and updating the language to reflect more modern types of pet food.

Response: FSIS is not updating its certified pet food program because it would not be the best use of Agency resources. As noted above, no companies are currently participating in the FSIS certified pet food program, and FDA is responsible for ensuring that pet food is safe for animals, produced under sanitary conditions, contains no harmful substances, and is truthfully labeled.

Comments: Several individuals argued that FSIS should not remove its certified pet food program because they disagree with FDA's pet food inspection regulations. These individuals stated that FSIS' requirements are stricter than FDA's requirements.

Response: This final rule will not impact the safety of pet food products. As explained above and in the proposed rule (86 FR 40369), no firms are participating in FSIS' certified pet food program. Comments on FDA's regulation of pet food are outside the scope of this rulemaking.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has been designated as a “non-significant” regulatory action under section 3(f) of E.O. 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget (OMB) under E.O. 12866.

This final rule clarifies that FDA has sole jurisdiction over pet food inspection, which benefits industry and consumers by reducing confusion. No firms are participating in the FSIS certified pet food program. Therefore, the final rule will not increase industry or Agency costs or have a negative impact on public health.

The FSIS Administrator certifies that, for the purposes of the Regulatory Flexibility Act (5 U.S.C. 601-602), this final rule is not expected to increase costs to industry.

There are no new paperwork or recordkeeping requirements associated with this final rule under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

This proposed rule will have no implications for Indian Tribal governments. More specifically, it does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Therefore, the consultation requirements of Executive Order 13175 do not apply.

Pursuant to the National Environmental Policy Act (42 U.S.C. 4321, et seq. ) (NEPA), Federal agencies must prepare an environmental impact statement (EIS) for any “major Federal actions significantly affecting the quality of the human environment” (42 U.S.C. 4332(2)(C)). NEPA established the Council on Environmental Quality (CEQ), which promulgated regulations (40 CFR parts 1501-1508) to govern NEPA compliance. When a major Federal action is unlikely to have significant environmental effects or the significance of the effects is unknown, the Agency may prepare an environmental assessment (EA) (40 CFR 1501.3(a)(2), 1501.5) (2020). Federal agencies also may identify classes of actions that normally do not have significant environmental effects and therefore do require the preparation of either an EA or EIS (40 CFR 1501.4(a)). Such classes of actions are “categorically excluded” from NEPA review unless extraordinary circumstances exist in which a normally excluded action may have a significant environmental effect (40 CFR 1501.3(a)(1), 1501.4)).

USDA's NEPA implementing regulations establish a categorical exclusion for specified categories of actions and the actions of certain USDA agencies and agency units (7 CFR 1b.3, 1b.4). USDA has determined that the listed agencies, including FSIS (7 CFR 1b.4(b)(6)), “conduct programs and activities that have been found to have no individual or cumulative effect on the human environment” (7 CFR 1b.4(a)). Accordingly, all FSIS actions are categorically excluded from preparation of an EA or EIS unless the Agency head determines that a particular action may have a significant environmental effect (Id.). The action thus is categorically excluded unless FSIS anticipates that extraordinary circumstances from ending the certification program may have a significant environmental effect (7 CFR 1501.4(b)). This final rule, which removes 9 CFR 355 from the Code of Federal Regulations, will not create any extraordinary circumstances that will result in this normally excluded action having a significant effect on the human environment. Therefore, this action is appropriately subject to the categorical exclusion from the preparation of an environmental assessment or environmental impact statement provided under 7 CFR 1b.4 of the USDA regulations.

This final rule has been reviewed under E.O. 12988, Civil Justice Reform. Under this rule: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) no administrative proceedings will be required before parties may file suit in court challenging this rule.

FSIS and USDA are committed to achieving the purpose of the E-Government Act (44 U.S.C. 3601, et seq. ) by, among other things, promoting the use of the internet and other information technologies and providing increased opportunities for citizens access to Government information and services, and for other purposes.

Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS website located at: https://www.fsis.usda.gov/policy/federal-register-rulemaking.

FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Constituent Update is available on the FSIS website. Through the website, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: https://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves and have the option to password protect their accounts.

Pursuant to the Congressional Review Act (5 U.S.C. 801, et seq. ), the Office of Information and Regulatory Affairs has determined that this rule is not a “major rule,” as defined by 5 U.S.C. 804(2).

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

Persons with disabilities who require alternative means of communication for program information ( e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint and at any USDA office or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by: (1) Mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410; (2) fax: (202) 690-7442; or (3) email: program.intake@usda.gov.

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

DOE maintains a previously approved incorporation by reference (IEC 62301 (Second Edition)) and incorporates by reference the following industry standards into the Code of Federal Regulations (“CFR”) at 10 CFR part 430:

Copies of ANSI/ASHRAE 103-2017 can be obtained from the American Society of Heating, Refrigerating, and Air-Conditioning Engineers, Inc., 180 Technology Parkway NW, Peachtree Corners, GA 30092, (800) 527-4723 or (404) 636-8400, or online at: www.ashrae.org.

Copies of ANSI Z21.86-2016 can be obtained from the CSA Group, 178 Rexdale Blvd., Toronto, ON, Canada M9W 1R3 or the American National Standards Institute, 25 W 43rd Street, 4th Floor, New York, NY 10036, (212) 642-4900, or online at: www.csagroup.org/store/ or www.ansi.org.

Copies of ASTM D2156-09 (R2018) can be obtained from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428-2959 or online at: www.astm.org.

Copies of IEC 62301 (Second Edition) can be obtained from the American National Standards Institute, 25 W 43rd Street, 4th Floor, New York, NY 10036, (212) 642-4900, or online at: www.webstore.ansi.org.

Copies of UL 729-2016, UL 730-2016, and UL 896-2016 can be obtained from Underwriters Laboratories, Inc., 2600 NW Lake Rd., Camas, WA 98607-8542 or online at: www.ul.com.

See section IV.N of this document for a further discussion of these standards.

Direct heating equipment (“DHE”) is included in the list of “covered products” for which DOE is authorized to establish and amend energy conservation standards and test procedures. (42 U.S.C. 6292(a)(9)) DOE defines “direct heating equipment” as vented home heating equipment and unvented home heating equipment. 10 CFR 430.2. (Hereafter in this final rule, the terms “vented heater” and “unvented heater” are used to describe the two types of DHE). DOE's energy conservation standards and test procedures for vented heaters are currently prescribed at 10 CFR 430.32(i) and 10 CFR part 430, subpart B, appendix O, “Uniform Test Method for Measuring the Energy Consumption of Vented Home Heating Equipment” (“appendix O”), respectively. DOE's test procedures for unvented heaters are prescribed at 10 CFR part 430, subpart B, appendix G, “Uniform Test Method for Measuring the Energy Consumption of Unvented Home Heating Equipment” (“appendix G”). DOE currently does not prescribe energy conservation standards for unvented heaters because, as the Department explained in an April 2010 final rule for DHE, DOE has previously determined that a standard would produce little energy savings (largely due to the fact that any heat losses are dissipated directly into the conditioned space) and because of limitations in the applicable DOE test procedure. 75 FR 20112, 20130 (April 16, 2010). The appendix G test procedure includes neither a method for measuring energy efficiency nor a descriptor for representing the efficiency of unvented heaters. Instead, appendix G provides a method to measure and calculate the rated output (for all unvented heaters) and annual energy consumption (for primary electric unvented heaters). The following sections discuss DOE's authority to establish and amend test procedures for vented and unvented heaters, as well as relevant background information regarding DOE's consideration of and amendments to test procedures for these products.

The Energy Policy and Conservation Act, as amended (“EPCA”), 1 authorizes DOE to regulate the energy efficiency of a number of consumer products and certain industrial equipment. (42 U.S.C. 6291-6317) Title III, Part B  2 of EPCA established the Energy Conservation Program for Consumer Products Other Than Automobiles, which sets forth a variety of provisions designed to improve energy efficiency. These products include DHE, the subject of this document. (42 U.S.C. 6292(a)(9))

The energy conservation program under EPCA consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. Relevant provisions of EPCA specifically include definitions (42 U.S.C. 6291), test procedures (42 U.S.C. 6293), labeling provisions (42 U.S.C. 6294), energy conservation standards (42 U.S.C. 6295), and the authority to require information and reports from manufacturers (42 U.S.C. 6296).

The Federal testing requirements consist of test procedures that manufacturers of covered products must use as the basis for: (1) Certifying to DOE that their products comply with the applicable energy conservation standards adopted under EPCA (42 U.S.C. 6295(s)), and (2) making representations about the efficiency of those products (42 U.S.C. 6293(c)). Similarly, DOE must use these test procedures to determine whether the products comply with any relevant standards promulgated under EPCA. (42 U.S.C. 6295(s)) EPCA defines the efficiency descriptor for DHE to be annual fuel utilization efficiency (“AFUE”). (42 U.S.C. 6291(22)(A))

Federal energy efficiency requirements for covered products established under EPCA generally supersede State laws and regulations concerning energy conservation testing, labeling, and standards. (42 U.S.C. 6297) DOE may, however, grant waivers of Federal preemption for particular State laws or regulations, in accordance with the procedures and other provisions of EPCA. (42 U.S.C. 6297(d))

Under 42 U.S.C. 6293, EPCA sets forth the criteria and procedures DOE must follow when prescribing or amending test procedures for covered products. EPCA requires that any test procedures prescribed or amended under this section shall be reasonably designed to produce test results which measure energy efficiency, energy use or estimated annual operating cost of a covered product during a representative average use cycle (as determined by the Secretary) or period of use and shall not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3))

In addition, EPCA requires that DOE amend its test procedures for all covered products to integrate measures of standby mode and off mode energy consumption into the overall energy efficiency, energy consumption, or other energy descriptor, taking into consideration the most current versions of Standards 62301  3 and 62807  4 of the International Electrotechnical Commission (IEC), unless the current test procedure already incorporates the standby mode and off mode energy consumption, or if such integration is technically infeasible. (42 U.S.C. 6295(gg)(2)(A)) If an integrated test procedure is technically infeasible, DOE must prescribe separate standby mode and off mode energy use test procedures for the covered product, if a separate test is technically feasible. Id.

EPCA also requires that, at least once every 7 years, DOE evaluate test procedures for each type of covered product, including DHE, to determine whether amended test procedures would more accurately or fully comply with the requirements for the test procedures to not be unduly burdensome to conduct and be reasonably designed to produce test results that reflect energy efficiency, energy use, and estimated operating costs during a representative average use cycle or period of use. (42 U.S.C. 6293(b)(1)(A))

If the Secretary determines, on her own behalf or in response to a petition by any interested person, that a test procedure should be prescribed or amended, the Secretary shall promptly publish in the Federal Register proposed test procedures and afford interested persons an opportunity to present oral and written data, views, and arguments with respect to such procedures. The comment period on a proposed rule to amend a test procedure shall be at least 60 days and may not exceed 270 days. In prescribing or amending a test procedure, the Secretary shall take into account such information as the Secretary determines relevant to such procedure, including technological developments relating to energy use or energy efficiency of the type (or class) of covered products involved. (42 U.S.C. 6293(b)(2)) If DOE determines that test procedure revisions are not appropriate, DOE must publish in the Federal Register its determination not to amend the test procedures. DOE is publishing this final rule in satisfaction of the 7-year review requirement specified in EPCA. (42 U.S.C. 6293(b)(1)(A))

As mentioned previously, DOE's existing test procedures for unvented heaters and vented heaters appear at appendix G and appendix O, respectively. DOE published a notice of proposed rulemaking (“NOPR”) on April 16, 2021 (“April 2021 NOPR”) that provides the full history of test procedure rulemakings for unvented heaters and vented heaters. 86 FR 20053, 20055-20056.

For unvented electric heaters that are the primary heating source for the home, appendix G includes provisions for measuring electric power and calculating annual energy consumption in sections 2.1 and 3.1, respectively. For all unvented heaters, appendix G includes provisions for determining the rated output, in section 3.3 for electric heaters and section 3.4 for natural gas, propane, or oil heaters. Appendix G does not contain provisions for determining energy efficiency, as unvented heaters are considered to be 100-percent efficient during the heating season because any heat losses are lost to the conditioned living space in which the unit is installed. Accordingly, DOE has not established energy conservation standards for unvented heaters.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2019-22-05, Amendment 39-19784 (84 FR 63569, November 18, 2019), (AD 2019-22-05). AD 2019-22-05 applied to all GE CF34-8C1, CF34-8C5, CF34-8C5A1, CF34-8C5B1, CF34-8C5A2, and CF34-8C5A3 (CF34-8C) model turbofan engines. The NPRM published in the Federal Register on December 29, 2021 (86 FR 73997). The NPRM was prompted by multiple reports of fuel leaks, some leading to engine fires, which have occurred as a result of malfunctions related to the OBV. Since the FAA issued AD 2019-22-05, the manufacturer redesigned the OBV, which terminates the need for the repetitive inspections of the OBV fuel tubes, OBV bleed air manifold link rod assemblies, and the OBV fuel fittings. Additionally, the FAA determined that GE CF34-8E2, CF34-8E2A1, CF34-8E5, CF34-8E5A1, CF34-8E5A2, CF34-8E6, and CF34-8E6A1 (CF34-8E) model turbofan engines are susceptible to the same unsafe condition as the CF34-8C model turbofan engines, and therefore, added the GE CF34-8E model turbofan engines to the applicability of this AD. GE published service information specifying procedures to replace certain OBVs installed on GE CF34-8C and CF34-8E model turbofan engines. In the NPRM, the FAA proposed to continue to require initial and repetitive inspections of the OBV fuel tubes, OBV bleed air manifold link rod assemblies, the OBV fuel fittings installed on GE CF34-8C model turbofan engines, and replacement of OBVs or related OBV link rod hardware that fail inspection. In the NPRM, the FAA proposed to require replacement of certain OBVs installed on GE CF34-8C model turbofan engines as a terminating action to the repetitive inspections. In the NPRM, the FAA also proposed to require replacement of certain OBVs installed on GE CF34-8E model turbofan engines. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA received comments from four commenters. The commenters were Air Line Pilots Association, International (ALPA), Horizon Air, Japan Airlines (JAL), and SkyWest Airlines, Inc. (SkyWest). The following presents the comments received on the NPRM and the FAA's response to each comment.

Horizon Air requested that the FAA provide guidance for compliance with the Required Actions, paragraphs (g)(4) and (5), in the event the FHs since new of the OBV is unknown. Horizon Air commented that paragraphs (g)(4) and (5) of the NPRM would require replacement of the OBV with a part eligible for installation within prescribed periods, which are predicated on the FHs since new of the OBV. Horizon Air reasoned that the NPRM does not include guidance for replacing an OBV if the FHs since new of the OBV is unknown.

In response to this comment, the FAA has added paragraph (g)(6) to this AD, allowing use of the FHs since new of the engine if the accumulated FHs since new of the OBV is unknown.

JAL requested that the FAA update paragraph (g)(4) of this AD to include a reference date for OBV FHs since new. JAL noted that although paragraph (g)(4) of the NPRM has the OBV FHs since new, it does not provide a reference date.

The FAA revised paragraphs (g)(4)(i) through (iii) of this AD to identify the reference date as requested by the commenter.

JAL requested that the FAA add a note referenced in GE CF34-8E Service Bulletin (SB) 75-0021 R00 to the Required Actions, which states, “For all OBVs, if the OBV was upgraded per S/B 75-0018 or the OBV cap was replaced per GEK 117619, CF34-8E Component Maintenance Manual (CMM), 80-12-41, Revision 03 or higher, the flight hours since upgrade or flight hours since the cap was replaced, as applicable, can be used instead of flight hours since new.”

In response to JAL's request, the FAA added paragraph (g)(7) to this AD.

SkyWest commented that they have found the costs to convert part number (P/N) 4123T71P02 or P/N 4123T71P03 are closer to $25,000 to $30,000 than the estimated $17,000 stated in the NPRM. SkyWest also commented that replacing the OBV on CF34-8E engines would take more than the 2 hours estimated in the NPRM. SkyWest reasoned that in their experience, it could take 8 hours to replace the OBV on CF34-8E engines.

In response to SkyWest's comment regarding the estimated costs to replace the OBV, the FAA updated the estimated parts costs from $17,230 to $20,330 in the Costs of Compliance section of this AD. The FAA disagrees with revising the estimated labor cost to replace the OBV. The cost analysis in AD rulemaking actions typically includes only the costs associated with complying with the AD and does not include secondary costs. The FAA's cost estimate includes the estimated work hours and parts costs to perform the required actions.

SkyWest noted concerns with OBVs modified to P/N 4123T71P06 since only the original equipment manufacturer (OEM) could modify the OBVs. SkyWest also commented that the OEM is currently having parts supply shortages that could jeopardize modifying the OBVs in the required timeline as proposed in paragraphs (g)(3) and (4) of the NPRM.

In response to SkyWest's comments, GE has communicated with the supplier and confirmed there is sufficient capacity and margin to meet the compliance times required by this AD. GE has also requested that the supplier plan improvements for engagement and logistics with the operators.

ALPA expressed support for the AD as written.

The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting the AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, and any other changes described previously, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA reviewed GE CF34-8C SB 75-0020 R04, dated May 10, 2019 (GE SB 75-0020). This SB specifies procedures for inspecting the bleed air manifold link rod assemblies; the supply, return, and drain fuel fittings; and the fuel tubes on the OBV. This SB also specifies procedures for performing corrective actions and replacing any OBVs or related OBV link rod hardware that fail the inspection criteria. The Director of the Federal Register approved the incorporation by reference of GE SB 75-0020 as of December 23, 2019 (84 FR 63569, November 18, 2019).

The FAA reviewed GE CF34-8C SB 75-0025 R01, dated August 1, 2019. This SB specifies procedures for replacing and upgrading the suspect population of OBVs VIN 5000728-104 (P/N 4123T71P02), VIN 5000728-106 (P/N 4123T71P03), and VIN 5080046-101 (P/N 4123T71P04).

The FAA reviewed GE CF34-8E SB 75-0019 R01, dated August 1, 2019. This SB specifies procedures for replacing and upgrading the suspect population of OBVs VIN 5000728-104 (P/N 4123T71P02), VIN 5000728-106 (P/N 4123T71P03), and VIN 5080046-101 (P/N 4123T71P04).

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

The FAA reviewed GE CF34-8C SB 75-0026 R00, dated February 21, 2020. This SB introduces OBV VIN 5080046-103 (P/N 4123T71P06).

The FAA also reviewed GE CF34-8E SB 75-0021 R00, dated February 21, 2020. This SB introduces OBV VIN 5080046-103 (P/N 4123T71P06).

The FAA estimates that this AD affects 1,172 engines installed on airplanes of U.S. registry.

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

The FAA estimates the following costs to do any necessary replacements that would be required based on the results of the inspection. The agency has no way of determining the number of aircraft that might need this replacement.

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

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

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

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

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

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

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

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

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain serial-numbered Pilatus Model PC-12/47E airplanes. The NPRM published in the Federal Register on February 10, 2022 (87 FR 7774). The NPRM was prompted by MCAI from the European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union. EASA issued AD 2020-0229, dated October 20, 2020 (referred to after this as “the MCAI”), to correct an unsafe condition on Pilatus Model PC-12/47E airplanes with serial number 2001 and larger. The MCAI states:

You may examine the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-0092.

In the NPRM, the FAA proposed to require removing the affected fuel transfer ejectors from service and proposed to prohibit installation of an affected fuel transfer ejector. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA received comments from Pilatus and the Airline Pilots Association, International (ALPA). The following presents the comments received on the NPRM and the FAA's response to each comment.

ALPA supported the NPRM without change.

Pilatus requested the FAA clarify the unsafe condition statement in paragraph (e) of the proposed AD. Pilatus disagreed with the conclusion that reduction in safety margins in the fuel system could result in loss of control of the airplane. Pilatus explained that a reduction in safety margins would not lead to loss of control of the airplane; in the event the engine is starved of fuel, it will shut down but not necessarily lead to a loss of control because the airplane could glide controllably for a period of time.

The FAA agrees and has revised paragraph (e) of this AD to state that the unsafe condition could lead to “loss of engine power or engine shutdown.”

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

The FAA reviewed Pilatus PC-12 Service Bulletin No. 28-014, dated August 12, 2020. This service information contains the serial numbers of the affected fuel transfer ejectors and specifies procedures for replacing the affected fuel transfer ejectors. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 10 airplanes of U.S. Registry. Although there are 54 affected fuel transfer ejectors worldwide, the FAA has no way of knowing how many affected parts may be installed on airplanes of U.S. Registry. The estimated cost on U.S. operators reflects the maximum possible cost based on the 10 airplanes of U.S. registry.

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

On October 10, 2021, the Coast Guard received an Application for Marine Event from the Castleton Boat Club for the Horsepower on the Hudson event. In response, on March 16, 2022, the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Special Local Regulation; 2022 Horsepower on the Hudson, Hudson River, Castleton, NY” (87 FR 14814). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this high speed boating event. During the comment period that ended April 15, 2022, we received one comment.

The Coast Guard is establishing a special local regulation for the Horsepower on the Hudson event from 10 a.m. to 4 p.m. on August 6, 2022. The special local regulation will cover all navigable waters of the Hudson River between Hudson River Lighted Buoy 202 (LLNR 38905) to Hudson River Light 204 (LLNR 38910).

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70041. The Captain of the Port New York/New Jersey (COTP) has determined that to ensure the safety of participants, vessels, and the navigable waters in the vicinity of the high speed race route and the spectator zone before, during, and after the scheduled event on August 06, 2022. The purpose of this rule is to protect all waterway users, including event participants and spectators, during the event.

As noted above, we received one comment on our NPRM published March 16, 2022. The comment was solely in favor of the rule. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

This rule establishes a special local regulation from 10 a.m. to 4 p.m. on August 6, 2022. The special local regulation will cover all navigable waters of the Hudson River between Hudson River Lighted Buoy 202 (LLNR 38905) to Hudson River Light 204 (LLNR 38910). The duration of the special local regulation is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled 10 a.m. to 4 p.m. high speed event. No vessel or person will be permitted to enter the regulated area without obtaining permission from the COTP or a designated representative.

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

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

This regulatory action determination is based on the size, location, duration, and time-of-day of the special local regulation.

Marine traffic will continue to be able to transit via the main navigable channel. The special local regulation is limited in duration and to a narrowly tailored geographic area with designated and adequate space for transiting vessels to pass via the main navigation channel when permitted by the COTP or designated representative. In addition, although this rule restricts access to the waters encompassed by the local regulation, the effect of this rule will not be significant because the local waterway users will be notified in advance via public Broadcast Notice to Mariners. To ensure the special local regulation will result in minimum impact the main navigation channel will be maintained allowing vessels to transit the Hudson River outside of the high speed area or the spectator area. Mariners will therefore be able to plan ahead and either transit through the available transit area or outside the periods of enforcement of the special local regulation. Moreover, mariners may be able to transit the high speed area or spectator areas with approval from the COTP.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a regulated area lasting 6 hours that would limit persons or vessels from transiting certain regulated areas during the scheduled event. It is categorically excluded from further review under paragraph L[61] of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

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

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

The event sponsor notified the Coast Guard that it will be conducting the Lady Liberty Sharkfest Swim on July 16, 2022, from 7:30 a.m. to 8:30 a.m. with approximately 200 participants and several support vessels. Participants will swim between Liberty Island, New York and Morris Canal, New Jersey. In response, on March 1, 2022, the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Safety Zone; Lady Liberty Sharkfest Swim, Upper New York Harbor, Liberty Island, NY” (87 FR 11371). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this marine event. During the comment period that ended March 31, 2022, we received one comment.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port New York (COTP) has determined that potential hazards associated with swim events occurring in high traffic areas of the Upper New York Harbor on July 16, 2022, will be a safety concern for anyone within a 100-yard radius of swimmers. The purpose of this rule is to protect maritime public and event participants from the hazards associated with the swim event until the conclusion of the event.

As noted above, we received one comment on our NPRM published March 1, 2022. This comment was in support of the rule. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

This rule establishes a temporary safety zone within 100 yards of each participant for the swim event on the navigable waters of the Upper New York Bay located between Liberty Island, New York, and Morris Canal, New Jersey. A portion of the navigable waters will be closed during the effective period to all vessel traffic except patrol crafts. The swim event will occur from approximately 7:30 a.m. until approximately 8:30 a.m. on July 16, 2022. In order to coordinate the safe movement of vessels within the area and to ensure that the area is clear of unauthorized persons and vessels before, during, and immediately after the swim event, this zone will be effective from approximately 7 a.m. until approximately 10 a.m. on July 16, 2022.

Vessels will still be able to transit the surrounding area and may be authorized to transit through the safety zone with the permission from the COTP or the designated representative. The COTP does not anticipate any negative impact on vessel traffic due to this safety zone.

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

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. Vessel traffic will be able to safely transit around this safety zone which will impact a small designated area of the Upper New York Harbor in vicinity of Ellis and Liberty Islands for 3 hours and during a time of day when vessel traffic is normally low. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission to enter the zone.

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

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

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

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

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

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

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting approximately 3 hours that will prohibit entry within 100 yards of participating swimmers for the Lady Liberty Sharkfest Swim. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration for Categorically Excluded Actions is available in the docket where indicated under ADDRESSES .

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

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

The Coast Guard will enforce the Safety Zones; Annual Events in the Captain of the Port Buffalo Zone listed in 33 CFR 165.939, Table 165.939(c)(1) for the Whiskey Island Paddlefest in Cleveland, OH. on all U.S. waters of Lake Erie; Cleveland Harbor, from 41°29′59.5″ N and 081°42′59.3″ W to 41°30′4.4″ N and 081°42′44.5″ W to 41°30′17.3″ N and 081°43′0.6″ W to 41°30′9.4″ N and 081°43′2.0″ W to 41°29′54.9″ N and 081°43′34.4″ W to 41°30′0.1″ N and 081°43′3.1″ W and back to 41°29′59.5″ N and 081°42′59.3″ W (NAD 83) from 7:15 a.m. through 1:15 p.m. on August 13, 2022. The scheduled date of zone enforcement differs from that published in 33 CFR 165.939 in order to accommodate the sponsoring organization's priority to better align their event schedule with co-occurring special local events, other paddle races taking place in the Great Lakes region, and to ensure availability of the personnel and material resources required.

Pursuant to 33 CFR 165.23, entry into, transiting, or anchoring within the safety zone during an enforcement period is prohibited unless authorized by the Captain of the Port Buffalo or a designated representative. Those seeking permission to enter the safety zone may request permission from the Captain of the Port Buffalo via channel 16, VHF-FM. Vessels and persons granted permission to enter the safety zone shall obey the directions of the Captain of the Port Buffalo or a designated representative. While within a safety zone, all vessels shall operate at the minimum speed necessary to maintain a safe course.

This notice of enforcement is issued under authority of 33 CFR 165.939 and 5 U.S.C. 552 (a). In addition to this notice of enforcement in the Federal Register , the Coast Guard will provide the maritime community with advance notification of this enforcement period via Broadcast Notice to Mariners or Local Notice to Mariners. If the Captain of the Port Buffalo determines that the safety zone need not be enforced for the full duration stated in this notice he or she may use a Broadcast Notice to Mariners to grant general permission to enter the respective safety zone.

On January 19, 2022, the H1 Unlimited notified the Coast Guard that it will be conducting a hydroplane testing event from 9 a.m. to 3 p.m. on May 20, 2022. The hydroplane event will consist of individual testing of 10 hydroplane vessels in between the I-5 and I-205 bridges on the Columbia River. The Captain of the Port Columbia (COTP) has determined that potential hazards associated with the high-speed hydroplane boat testing would be a safety concern for anyone within the regulated area.

In response, on March 30, 2022 the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone; Columbia River, Vancouver, WA (87 FR 18757). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this fireworks display. During the comment period that ended May 2, 2022, we received two comments.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable because immediate action is needed to respond to the potential safety hazards associated with the high-speed hydroplane boat testing. The Coast Guard's limited notice of the parameters of the high-speed boat testing makes it necessary to expedite the effective date of this rule.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector Columbia River (COTP) has determined that the potential hazards associated with high-speed hydroplane boat testing would be a safety concern for anyone within the regulated area. The purpose of this rule is to ensure safety of vessels and the navigable waters in the safety zone before, during, and after the scheduled event.

As noted above, we received two comments on our NPRM published May 30, 2022. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

One comment expressed concern that the waterway would be completely taken over for use by a private company. However, the safety zone only covers a specific duration of 7 hours for a single day. Vessels that need or want to enter the safety zone may seek permission from the COTP to do so. Another comment raises concerns about the environmental impact of the boat racing event itself, conflating the event and the safety zone. Due to the size and length of time the zone will be in effect, the safety zone will have a miminal expected impact on the environment.

This rule establishes a safety zone from 8:30 a.m. to 3:30 p.m. on May 20, 2022. The safety zone covers all navigable waters of the Columbia River, from surface to bottom, starting approximately 700 yards east of the I-5 bridge from shoreline to shoreline heading east for approximately 1.2 miles; specifically beginning at the shoreline at 45°36′40.7″ N, 122°40′11.2″ W, northeast to 45°37′08.7″ N, 122°39′53.8″ W, southeast to 45°36′41.3″ N, 122°38′32.0″ W, thence southwest to 45°36′15.8″ N, 122°38′53.0″ W, and along the shoreline back to the beginning point. The duration of the safety zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled 9 a.m. to 3 p.m. high-speed hydroplane boat testing. No vessel or person is permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

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

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

This regulatory action determination is based on the size, location, and the duration of the safety zone. The safety zone will impact a 1.2 mile stretch of the Columbia River during the hydroplane boat testing for 7 hours and thus is limited in scope. The Coast Guard will issue a Broadcase Notice to Mariners via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission to enter.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting 7 hours that would prohibit entry within an approximate 1.2 miles of the Columbia River for the duration of a high-speed hydroplane testing event. It is categorically excluded from further review under L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

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

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

WIPO Standard ST.26 is the new international standard developed and adopted by WIPO and member states for purposes of presenting biotechnology information in patent applications. It will apply to international and national applications filed on or after July 1, 2022. New provisions in 37 CFR 1.831 through 1.835 implement WIPO Standard ST.26. Applications pending prior to July 1, 2022, will not have to comply with WIPO Standard ST.26; rather, such applications will require the submission of a “Sequence Listing,” as defined in 37 CFR 1.821(a), in compliance with 37 CFR 1.8211.825.

Under WIPO Standard ST.26 (as implemented by 37 CFR 1.831 through 1.835), patent applications that contain disclosures of nucleotide and/or amino acid sequences must present the associated biological sequence data in a standardized electronic format (a “Sequence Listing XML”) as a separate part of the specification. In particular, WIPO Standard ST.26 permits applicants to submit a single, internationally acceptable sequence listing in a language-neutral format using specified International Nucleotide Sequence Database Collaboration (INSDC) identifiers in international applications filed under the Patent Cooperation Treaty (PCT) and in national and regional applications in the intellectual property offices (IPOs) of WIPO member states. As a result, a single sequence listing in compliance with WIPO Standard ST.26 can be prepared for use in the IPOs of WIPO member states.

For applications filed on or after July 1, 2022, the changes in this final rule include the: (1) Creation of new rules (37 CFR 1.831 through 1.839) that incorporate by reference WIPO Standard ST.26; (2) use of INSDC sequence data elements to replace numeric identifiers used in the previous Standard ST.25 for the submission of nucleotide and/or amino acid sequences; (3) modification of rules of practice to include reference to a “Sequence Listing XML”; (4) elimination of the ability to file a paper or Portable Document Format (PDF) copy of nucleotide and/or amino acid sequences; (5) elimination of the option to include within a “Sequence Listing XML,” sequences with fewer than 4 specifically defined amino acids and fewer than 10 specifically defined nucleotides; and (6) clarification and simplification of the rules to aid in understanding the requirements set forth.

In an effort to streamline and reduce existing procedural requirements and to implement WIPO Standard ST.26, the USPTO is amending its rules of practice (by adding 37 CFR 1.831 through 1.839) for submitting biological sequence data associated with disclosures of nucleotide and/or amino acid sequences in patent applications filed on or after July 1, 2022. These changes also respond to the needs of our customers to comply with WIPO Standard ST.26.

To decrease the burden on applicants who file patent applications containing nucleotide and/or amino acid sequences internationally, the USPTO has worked with other WIPO member states as part of the Committee on WIPO Standards (CWS) to develop a single, internationally acceptable sequence listing standard for use in patent applications filed in those member states. Beginning in October of 2010, the CWS established a task force to propose a revised standard for the filing of nucleotide and/or amino acid sequence listings in XML file format. To obtain public input on the content of WIPO Standard ST.26, the USPTO issued requests for comments in 2012 and 2016. See Request for Comments on the Recommendation for the Disclosure of Sequence Listings Using XML (Proposed ST.26), 77 FR 28541 (May 15, 2012); and Standard ST.26—Request for Comments on the Recommended Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings Using XML (eXtensible Markup Language), 81 FR 74775 (October 27, 2016). The adopted version of WIPO Standard ST.26 takes those comments into account. To achieve the goals WIPO and its member states (including the United States) set out by developing the sequence listing standard for presenting data consistently across all IPOs, all WIPO member states agreed to implement WIPO Standard ST.26 for international and national applications filed on or after July 1, 2022. Therefore, in view of this final rule, applications filed in the United States on or after July 1, 2022, will need to conform to WIPO Standard ST.26 as implemented in 37 CFR 1.831 through 1.839, which requires submitting sequence listings in XML format.

Under the final rule, applications that claim benefit or priority to an earlier application, where the earlier application contained a sequence listing that complied with the requirements of Standard ST.25 or other earlier requirements, must comply with the new rules that incorporate by reference WIPO Standard ST.26. To facilitate compliance, WIPO, with input from WIPO member states, developed WIPO Sequence, a sequence listing authoring and validating tool that applicants can use to prepare and validate their sequence listings in XML format, as discussed below. The USPTO is adding to the patent rules (37 CFR part 1) by incorporating by reference WIPO Standard ST.26, and providing conforming amendments to the current rules.

To ensure that biological sequence data associated with the disclosures of nucleotide and/or amino acid sequences in patent applications can be widely disseminated and searchable by the public and IPOs, the USPTO works with the National Center for Biotechnology Information (NCBI) on the inclusion of patent sequence data in the GenBank searchable database. For the NCBI to include all sequence data from the USPTO, the data must be provided in INSDC format so it is compatible with GenBank. The Standard ST.25 format sequence listings cannot be readily converted to INSDC format, resulting in only a fraction of patent sequence information appearing in GenBank. This data loss limits the sequence information available to the public and exchanged with other sequence database providers ( e.g., the National Institute of Genetics (NIG) in Japan, the DNA Data Bank of Japan (DDBJ), and the European Molecular Biology Laboratory, European Bioinformatics Institute (EMBL-EBI). WIPO has been working with the WIPO member states to create, adopt, and implement WIPO Standard ST.26 for sequence listing submissions in XML file format, which has the INSDC data elements to address the data loss. WIPO Standard ST.26 aims to enhance the accuracy and quality of biological sequence data that is publicly disseminated. With the adoption and implementation of WIPO Standard ST.26, more complete biological sequence data from patents and patent applications will be included in GenBank and thus be accessible by the public. The change from American Standard Code for Information Interchange (ASCII) plain text format to XML format will result in sequence data having computer tags that facilitate sorting and retrieving and will permit ease of access to the data. Additionally, the NCBI plans to stop accepting data in Standard ST.25 format for inclusion in GenBank approximately three to five years after the WIPO Standard ST.26 transition date (July 1, 2022).

The WIPO “Handbook on Industrial Property Information and Documentation” sets forth standards for the presentation of data in many contexts. WIPO Standard ST.26 is titled “RECOMMENDED STANDARD FOR THE PRESENTATION OF NUCLEOTIDE AND AMINO ACID SEQUENCE LISTINGS USING XML (EXTENSIBLE MARKUP LANGUAGE).” The CWS adopted the current version (version 1.5) in November of 2021. In October of 2021, at the Assemblies of Member States of WIPO, the member states agreed on July 1, 2022, as the implementation date of WIPO Standard ST.26. This final rule incorporates by reference WIPO Standard ST.26. The standard is available from WIPO, 34 chemin des Colombettes, 1211 Geneva 20 Switzerland, www.wipo.int. and also as provided for in 37 CFR 1.839.

WIPO Standard ST.26 is composed of eight documents, namely, the main body of the standard, a first annex (Annex I) setting forth the controlled vocabulary for use with the main body, a second annex (Annex II) setting forth the Document Type Definition (DTD) for the Sequence Listing, a third annex (Annex III) containing a sequence listing specimen (XML file), a fourth annex (Annex IV) setting forth the character subset from the Unicode Basic Latin Code Table, a fifth annex (Annex V) setting forth additional data exchange requirements for IPOs, a sixth annex (Annex VI) containing a guidance document with illustrated examples, and a seventh annex (Annex VII) setting forth recommendations for the transformation of a sequence listing from Standard ST.25 format to WIPO Standard ST.26 format, including guidance on how to avoid adding or deleting subject matter.

The main body of WIPO Standard ST.26 defines the disclosures of nucleotide and/or amino acid sequences in patent applications that must be presented in a sequence listing in XML format in the manner specified in the standard. As detailed in paragraph eight of the main body, a sequence listing in XML format must not include any sequences having fewer than 10 specifically defined nucleotides, or fewer than 4 specifically defined amino acids. If such sequences are included in the disclosure, they must not be assigned a sequence identification number. The main body establishes the requirements for the representation of nucleotide and/or amino acid sequences and the requirements for the XML file format for a sequence listing. Annex I contains controlled vocabulary that provides nucleotide base codes, lists of modified nucleotides and their abbreviations, amino acid codes, and a list of modified amino acids and their abbreviations. In addition, Annex I provides defined feature keys and qualifiers used for nucleotide and/or amino acid sequences in the XML file for a sequence listing. Annex I specifically identifies qualifiers with language-dependent “free text” values that may require translation for national and regional procedures. Annex II provides the DTD setting forth the technical specifications to which a submitted Sequence Listing XML must conform. Annex III provides a link to a specimen of a sequence listing that is compliant with WIPO Standard ST.26 and that shows a representation of an entire sequence listing in XML format. Annex IV provides a table of the character subset from the Unicode Basic Latin Code that will be used in the XML file for the sequence listing. Annex V provides guidance to WIPO member states on how certain sequence elements should be populated when data is exchanged with database providers. Annex VI, containing the guidance document, ensures that all applicants and WIPO member states understand the requirements for inclusion and representation of sequence disclosures. This guidance document was developed, in part, to address concerns raised in response to the USPTO's requests for comments in 2012 and 2016, mentioned above. The guidance document illustrates the requirements of selected paragraphs in the main body of WIPO Standard ST.26 through specific examples of nucleotide and amino acid biological sequence data. Additionally, the document provides guidance on the manner in which biological sequence data is represented in a sequence listing in XML format that is compliant with WIPO Standard ST.26. Annex VII addresses the mandatory requirements of WIPO Standard ST.26, and the potential consequence of these requirements when transforming a compliant Standard ST.25 sequence listing into a WIPO Standard ST.26 sequence listing. Annex VII also provides detailed guidance on how to avoid adding or deleting subject matter due to the additional requirements of WIPO Standard ST.26.

Transitioning from rules based on WIPO Standard ST.25 ( i.e., the basis for USPTO rules 37 CFR 1.821 through 1.825, regarding “Sequence Listings”) to rules based on WIPO Standard ST.26 will be beneficial to both patent applicants filing sequence listings and IPOs receiving applications containing disclosures of nucleotide and/or amino acid sequences requiring sequence listings. WIPO Standard ST.26 provides clear requirements for what must be included in a sequence listing and how sequences must be represented. For example, it standardizes the representation of modified nucleotide sequences and amino acid sequences as well as variants derived from primary sequences. Since WIPO Standard ST.26 contains a guidance document that illustrates the requirements for the inclusion and representation of biological sequence data, patent applicants will have a better understanding of the requirements for the presentation of biological sequence data in a compliant sequence listing under WIPO Standard ST.26 (as implemented by 37 CFR 1.831 through 1.839). Additionally, since WIPO Standard ST.26 only allows XML format (an electronic computer readable format), this final rule eliminates the potential for differences between a sequence listing filed in paper/PDF format and the required electronic computer readable format (CRF). As a further benefit, the IPOs of WIPO member states will no longer need to expend resources to process paper sequence listings and perform necessary checks on the contents of paper documents.

Unlike rules based on Standard ST.25, rules based on WIPO Standard ST.26 will allow patent applicants to file a single sequence listing with the USPTO (with the exception of changes to comply with national language requirements) that will be acceptable to the IPOs of all WIPO member states. Under Standard ST.25, IPOs have interpreted and enforced rules differently due to the imprecise language in that standard. This has resulted in the frustrating situation in which applicants generate sequence listings that may be accepted in one IPO but not another.

WIPO Standard ST.26 was drafted to precisely define what must and must not be included in a sequence listing and how sequences must be represented in a sequence listing. The “Guidance document with illustrated examples” in Annex VI of WIPO Standard ST.26 demonstrates the application of the rules to real-world sequence disclosure examples, reducing the possibility of misinterpretation by IPOs or applicants.

Due to the improved data structure of XML, transitioning to rules based on WIPO Standard ST.26 will increase the quality of the examination of patent applications containing biological sequence data since a more comprehensive search will be possible. Sequence listings submitted in accordance with WIPO Standard ST.26 allow for targeted searching of both sequence annotation and newly required sequence types, such as D-amino acids, nucleotide analogues, and linear portions of branched sequences. Finally, sequence listing submissions under rules based on WIPO Standard ST.26 will enhance public database content, as they include the sequence annotations ( e.g., feature keys and qualifiers) used by database providers to describe biological sequence data. WIPO Standard ST.26 standardizes sequence variant presentation, the annotation of modified and unusual residues, feature location descriptors, the use of feature keys and qualifiers, organism names, and the presentation of coding regions. Incorporation by reference of WIPO Standard ST.26 into USPTO rules promotes data exchange between the USPTO and the NCBI due to the use of INSDC identifiers required by database providers. The presence of additional data, as well as the enhanced compatibility to facilitate the exchange of data, will increase the value of database searches that relate to nucleotide and amino acid sequences for biotechnology stakeholders.

Requiring compliance with WIPO Standard ST.26 for an application filed on or after July 1, 2022, will reduce the complexity and cost of the long-term maintenance of information technology (IT) systems for accepting sequence listings in multiple formats, provide a clear implementation date, and facilitate the transition to the format requirements of database providers. In addition, a requirement to submit a single sequence listing in XML format will result in better preservation, accessibility, and sorting of the submitted sequence data for the public.

To comply with rules based on WIPO Standard ST.26, patent applicants will be able to generate a sequence listing compliant with WIPO Standard ST.26 using WIPO Sequence, a desktop application developed by WIPO and adopted by WIPO member states. WIPO Sequence has two functions: An authoring function and a validation function. Patent applicants will be able to author and validate their sequence listing using WIPO Sequence to comply with the requirements of WIPO Standard ST.26. Such a sequence listing will be accepted by all the IPOs of the WIPO member states. Thus, the burden of generating a sequence listing that is acceptable across all WIPO member states will be significantly decreased for patent applicants under WIPO Standard ST.26. This tool is downloadable, free of charge, from the WIPO website. The current version of WIPO Sequence is accessible at www.wipo.int/standards/en/sequence/index.html. This version, subject to updates, will allow the public to become familiar with the tool and its dual functionalities.

WIPO Sequence will allow a user to create and save (author) patent application data and biological sequence data in a project, validate the project to ensure all required information is present, and generate a sequence listing in WIPO Standard ST.26 XML format. Information can be entered into a project manually, or data can be imported from a source file in one of a number of file types. WIPO Sequence can import data from other WIPO Standard ST.26 projects, WIPO Standard ST.26 XML sequence listings, Standard ST.25 sequence listing text files, raw files, multi-sequence format files, and FASTA (FAST-All-a DNA and protein sequence alignment software package) files. Feature keys, qualifiers, and organism names are available to select from drop-down lists, simplifying the creation of sequence listings. Applicant and inventor names, as well as custom organism names, can be stored in WIPO Sequence for easy access. To facilitate the review of data entered into a project, WIPO Sequence can generate a “human-readable” version (a text version of the sequence data) of the sequence listing in addition to the XML sequence listing.

WIPO Sequence includes an integrated validation function that will alert users to most errors in a project or sequence listing data. The validation function generates a report that clearly lists every detected error, the location of the error, and the detected value of the error, along with a link to the sequence in question, thereby ensuring users can correct errors before generating a final sequence listing. While the validation function will alert a user to most errors in a project or sequence listing, there are a small number of errors that can be detected only by human review (for example, an inappropriate organism name). In those cases, the integrated validation function will list a “warning” in the validation report, reminding users of the applicable/relevant rule and urging them to check their input values before generating a final sequence listing.

A sequence listing in Standard ST.25 format cannot automatically be converted into WIPO Standard ST.26 format because certain data elements required for a sequence listing compliant with WIPO Standard ST.26 are not present in Standard ST.25. Therefore, conversion of a sequence listing in Standard ST.25 format to Standard ST.26 format necessarily requires additional input from the applicant. WIPO Sequence, supplemented by significant guidance from WIPO and the USPTO (in Annex VI and Annex VII of WIPO Standard ST.26), will help applicants accomplish this task. Users can import a Standard ST.25 sequence listing into a project, and WIPO Sequence automatically performs many of the necessary conversions. An Import Report is generated that alerts the user to all data conversions and lists all sequence entries that require additional input. In response to concerns raised regarding the USPTO's requests for comments in 2012 and 2016, the USPTO, in conjunction with WIPO, developed Annex VII to provide detailed guidance to help applicants avoid added or deleted subject matter when converting a sequence listing from Standard ST.25 format into Standard ST.26 format.

To ensure that IPOs can validate and accept sequence listing projects from applicants generated with WIPO Sequence, WIPO is developing a Standard ST.26 sequence listing validation tool, WIPO Sequence Validator. WIPO Sequence Validator will be for use by IPOs. WIPO Sequence Validator will be synchronized with the validation function in the WIPO Sequence tool. The USPTO is integrating WIPO Sequence Validator into its internal IT systems. The WIPO Sequence Validator will apply the same validation rules as WIPO Sequence. Therefore, filers will have a greater level of confidence that a sequence listing authored and validated by WIPO Sequence will comply with the USPTO rules for a “Sequence Listing XML” (37 CFR 1.831 through 1.835) and be accepted, given that the WIPO Sequence Validator that the USPTO will use is based on WIPO Standard ST.26.

In accordance with this final rule, an application that has a filing date on or after July 1, 2022, will be required to provide a “Sequence Listing XML” in accordance with 37 CFR 1.831 through 1.835 for disclosures of any nucleotide and/or amino acid sequences that meet the definitions of 37 CFR 1.831(a) and (b). This includes applications having an international filing date on or after July 1, 2022, that claim benefit or priority to applications with filing dates before July 1, 2022. Such applications include, but are not limited to, applications having one or more benefit or priority claims under 35 U.S.C. 119(e) (claiming the benefit of a provisional), 35 U.S.C. 120 (claiming the benefit as a continuation and/or continuation-in-part), 35 U.S.C. 121 (claiming the benefit as a divisional), 35 U.S.C. 365(c) (claiming the benefit as a continuing application to a PCT application), or 35 U.S.C. 119(a)-(d) or 35 U.S.C. 365(a) (claiming the priority to a foreign filed application or a prior filed PCT). If a prior application to which benefit or priority is claimed contains a “Sequence Listing” in Standard ST.25 format (in compliance with 37 CFR 1.821 through 1.825), the applicant will be required to convert that “Sequence Listing” to WIPO Standard ST.26 format (a “Sequence Listing XML” in compliance with 37 CFR 1.831 through 1.835) for inclusion in the new application filed on or after July 1, 2022.

As provided in 35 U.S.C. 363, the filing date of an international stage application is also the filing date for the national stage application filed under 35 U.S.C. 371. Accordingly, for applications submitted under 35 U.S.C. 371, WIPO Standard ST.26 will apply to such applications based on the international filing date of the corresponding international application, rather than the date of submission of the national stage application in the USPTO.

Compliance with 37 CFR 1.831 through 1.835 (rules based on WIPO Standard ST.26) is also applicable to any reissue application filed on or after July 1, 2022, where the disclosure or claims contain nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(a) or (b). The filing date of the originally granted patent for which reissue is sought is not relevant in determining the applicability date of this final rule.

Relying on the actual filing date of an application to determine whether sequence information must conform to 37 CFR 1.821 through 1.825 (rules based on Standard ST.25) or 37 CFR 1.831 through 1.835 (rules based on WIPO Standard ST.26) will simplify the application of the sequence rules, both for the USPTO and the applicant. Though 37 CFR 1.821 through 1.825 are not revised by this final rule, note that 37 CFR 1.821 through 1.825 will not be applicable to applications filed on or after July 1, 2022, as a result of this final rule.

For applications filed on or after July 1, 2022, the USPTO patent electronic filing system will prohibit an applicant from submitting both a “Sequence Listing XML” (a sequence listing that conforms to WIPO Standard ST.26 as implemented in 37 CFR 1.831 through 1.835) and a “Sequence Listing” (a sequence listing that conforms to ST.25 as implemented in 37 CFR 1.821 through 1.825) in the same submission. Filing a “Sequence Listing” in an application filed on or after July 1, 2022, will result in a notice informing applicant that the submission fails to comply with 37 CFR 1.831 through 1.834 and will require submission of a “Sequence Listing XML.”

While implementing regulations and procedures for ST.26, the USPTO recognized that an applicant might erroneously provide a “Sequence Listing” (one in ASCII plain text file format) even though a “Sequence Listing XML” is required. Therefore, in the rare circumstance in which a “Sequence Listing” is submitted in an application filed on or after July 1, 2022, the “Sequence Listing” present in the Office file wrapper of the application at issue may be used to provide support for the submission of a compliant “Sequence Listing XML.” The applicant's reliance on the “Sequence Listing” to support the compliant “Sequence Listing XML” would be by way of the safeguard under 37 CFR 1.57(b), if an earlier filed application contains a proper “Sequence Listing” in .txt file format, or via a grantable petition under 37 CFR 1.182, only if the application does not have a proper benefit or priority claim present on the filing date to an earlier filed application.

An applicant may rely on the provisions in 37 CFR 1.57(b), as described in the Manual of Patent Examining Procedure at section 217, to support the required “Sequence Listing XML” as an “inadvertently omitted portion of the specification or drawing(s).” To rely on 37 CFR 1.57(b), a compliant “Sequence Listing” must have been submitted in an earlier filed application to which the present application makes a proper benefit or priority claim, and the “Sequence Listing” was present on the filing date of the earlier filed application ( i.e., the earlier filed application contains a compliant “Sequence Listing” submitted under 37 CFR 1.821(c)(1) as an ASCII plain text file (with a proper incorporation by reference statement in the specification), 37 CFR 1.821(c)(2) as a PDF copy, or 37 CF 1.821(c)(3) on physical sheets of paper). An applicant would be required to submit: (1) A compliant “Sequence Listing XML” under 37 CFR 1.835(a)(1); (2) a statement identifying where the inadvertently omitted portion of the specification can be found ( e.g., identifying the nucleotide and/or amino acid sequence information in the compliant “Sequence Listing” from the earlier filed application that forms the basis for the “Sequence Listing XML”), see 37 CFR 1.835(a)(3); (3) a statement identifying the nucleotide and/or amino acid sequences of the “Sequence Listing,” submitted (in the earlier filed application) under 37 CFR 1.821(c)(1) as an ASCII plain text file (with a proper incorporation by reference statement in the specification), 37 CFR 1.821(c)(2) as a PDF copy, or 37 CFR 1.821(c)(3) as physical sheets of paper, which forms the basis for the compliant “Sequence Listing XML”; (4) a statement that the “Sequence Listing XML” does not introduce new matter into the application, see 37 CFR 1.835(a)(4); and (5) a statement that all or a portion of the specification or drawings, as found in the “Sequence Listing XML,” were inadvertently omitted from the application. The availability of relief under 37 CFR 1.57(b) precludes the filing of a grantable petition under 37 CFR 1.182 seeking the same relief.

A petition under 37 CFR 1.182 would require: (1) A compliant “Sequence Listing XML” under 37 CFR 1.835(a)(1); (2) a statement identifying the nucleotide and/or amino acid sequence information of the “Sequence Listing” submitted as an ASCII plain text file that forms the basis for the “Sequence Listing XML” ( i.e., identifying the nucleotide and/or amino acid sequence information found in the “Sequence Listing” from the earlier submitted ASCII “Sequence Listing”) that is relied on for submission of a compliant “Sequence Listing XML,” see 37 CFR 1.835(a)(3); and (3) a statement that the “Sequence Listing XML” does not introduce new matter into the application, as required by 37 CFR 1.835(a)(4). In such circumstances, for record retention purposes, any “Sequence Listing” submitted as an ASCII plain text file will be retained in the official record for the application.

Section 1.52: Section 1.52 (e)(1)(ii) is amended to include reference to a “Sequence Listing XML” submitted under § 1.831(a) in compliance with §§ 1.832 through 1.834.

Section 1.52(e)(3)(iii) is amended to more explicitly indicate that the contents of each read-only optical disc must be in ASCII plain text and if compressed, must be compressed in accordance with § 1.58 for “Large Tables,” § 1.96 for a “Computer Program Listing Appendix,” or § 1.824 for a “Sequence Listing” or CRF of the “Sequence Listing,” as applicable.

Section 1.52(e)(3)(iv) is added to require that the contents of each read-only optical disc for a “Sequence Listing XML” must be in XML file format and, if compressed, must be compressed in accordance with § 1.834.

Section 1.52(e)(7) is amended to add that any amendment to the information on a read-only optical disc previously submitted in relation to a “Sequence Listing XML” must be made by way of a replacement read-only optical disc in accordance with § 1.835(b).

Section 1.52(f)(1) is amended to add that any XML file submitted on a read-only optical disc is excluded from the application size fee determination if the read-only optical disc contains a “Sequence Listing XML” in compliance with § 1.831(a). The provision at 35 U.S.C. 41(a)(1)(G) provides the basis for excluding “any sequence listing,” when filed in electronic medium, from the application size fee determination. A “Sequence Listing XML” is considered as “any sequence listing.”

Section 1.52(f)(1)(i) is amended to reference any “Sequence Listing XML” in compliance with § 1.831(a).

Section 1.52(f)(2) is amended to indicate that any XML file, submitted via the USPTO patent electronic filing system for a “Sequence Listing XML” in compliance with § 1.831(a) is excluded from the application size fee determination. The provision at 35 U.S.C. 41(a)(1)(G) provides the basis for excluding “any sequence listing,” when filed in an electronic medium, from the application size fee determination. A “Sequence Listing XML” is considered as “any sequence listing.”

Section 1.52(f)(2)(i) is amended to add a reference to any “Sequence Listing XML” in compliance with § 1.831(a).

Section 1.52(f)(3) is amended to add that any “Sequence Listing XML” of 300 MB-800 MB is subject to the surcharge set forth in § 1.21(o)(1) and also add that any “Sequence Listing XML” over 800 MB is subject to the surcharge set forth in § 1.21(o)(2).

Section 1.53: Section 1.53(c)(4) is revised to indicate that a separate sequence listing in a provisional application disclosing nucleotide and/or amino acid sequences is not required, but any biological sequence data submitted in a provisional application filed on or after July 1, 2022, must be a “Sequence Listing XML” in compliance with §§ 1.831 through 1.834. This change does not apply to provisional applications filed before July 1, 2022.

Section 1.77: Section 1.77(b)(5) is amended to reorganize the provisions to § 1.77(b)(5)(i) for an incorporation by reference statement for ASCII plain text files submitted for a “Computer Program Listing Appendix” (§ 1.77(b)(5)(i)(A)), a “Sequence Listing” (§ 1.77(b)(5)(i)(B)), and “Large Tables” (§ 1.77(b)(5)(i)(C)). Section 1.77(b)(5)(ii) is added to provide for the provisions for an incorporation by reference statement for a “Sequence Listing XML” submitted via the USPTO patent electronic filing system or on one or more read-only optical discs.

Section 1.121: Section 1.121(b) is amended to revise the reference for a “Sequence Listing” and eliminate the reference to a CRF of a “Sequence Listing,” since a separate CRF (under § 1.821(e)(1) or (2)) is not part of the specification. The amendment also adds an exception to amendment practice for a “Sequence Listing XML” (§ 1.831(a)).

Section 1.121(b)(6) is amended to require that changes to a “Sequence Listing XML” be made in accordance with § 1.835.

Section 1.173: The heading of § 1.173(b)(1) is amended to include “ `Sequence Listing XML' (§ 1.831(a)).”

Section 1.173(b)(1)(i) is amended to add an exception to reissue amendment practice for a “ `Sequence Listing XML' (§ 1.831(a)).”

Section 1.173(b)(1)(ii) is amended to provide that changes to a “Sequence Listing XML” must be made in accordance with § 1.835.

Section 1.173(d) is amended to add a “Sequence Listing XML” (§ 1.831(a)) among the items that are excluded from the manner of making amendments in a reissue application. Reference to specific CFR provisions for “Large Tables” (§ 1.58(c)), a “Computer Program Listing Appendix” (§ 1.96(c)), and a “Sequence Listing” (§ 1.821(c)) were added.

Section 1.211: Section 1.211(c) is amended to add a “Sequence Listing” in compliance with §§ 1.821 through 1.825 (if applicable) for an application filed before July 1, 2022, and a “Sequence Listing XML” in compliance with §§ 1.831 through 1.835 (if applicable) for an application filed on or after July 1, 2022, to the currently listed items that may delay application publication if not present.

Section 1.495: Section 1.495(c)(5) is amended to delineate between translations needed for a sequence listing in international applications entering the national stage in the United States and having an international filing date before July 1, 2022, and a sequence listing in XML format for international applications entering the national stage in the United States and having an international filing date on or after July 1, 2022. Specifically, the amendment indicates that a sequence listing need not be translated for national stage entry if it complies with PCT Rule 12.1(d) and the description complies with PCT Rule 5.2(b) for applications having an international filing date before July 1, 2022. However, the amendment indicates that a sequence listing in XML format must be translated for national stage entry if it was submitted in an international application having an international filing date on or after July 1, 2022, with non-English language values for any language-dependent free text qualifiers. Note that an invention title is not considered a “language-dependent free text qualifier” for purposes of this rule, and translation of the invention title is not required.

Section 1.495(c)(5), as well as §§ 1.833(b)(3) and 1.835(d)(2) as discussed below, were proposed to require that the “Sequence Listing XML” contain at least one invention title in English. This proposal has not been adopted in this final rule. The proposed requirement for a translation of the title into English was not adopted in the final rule because applicants in the international phase need only provide a title in the language of filing, which can be in a language other than English.

Section 1.530: The heading of § 1.530(d)(1) is amended to include “ `Sequence Listing XML' (§ 1.831(a)).”

Section 1.530(d)(1)(i) is amended to add an exception to reexamination amendment practice for a “ `Sequence Listing XML' (§ 1.831(a)).”

Section 1.530(d)(1)(ii) is amended to provide that changes to a “Sequence Listing XML” must be made in accordance with § 1.835.

Section 1.704: Section 1.704(f) is amended to add a “Sequence Listing XML” in compliance with §§ 1.831 through 1.835 (if applicable) to the list of items required for an application filed under 35 U.S.C. 111(a) to be in condition for examination for purposes of calculating a reduction in patent term adjustment. The amendment also adds a “Sequence Listing XML” in compliance with §§ 1.831 through 1.835 (if applicable) to the list of items that must be submitted in an international application for such an application to be in condition for examination when the application has entered the national stage as defined in § 1.491(b). Lastly, the rule is also amended to add a “Sequence Listing XML” in compliance with §§ 1.831 through 1.835 (if applicable) to the current list of items required for an application to be considered compliant, for purposes of determining a patent term adjustment reduction, on the filing date of the latest reply (if any) correcting the papers, drawings, or “Sequence Listing” that is prior to the date of the mailing of either an action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151, whichever occurs first. Lastly, the term “Sequence Listing” replaces “sequence listing,” since §§ 1.821 through 1.825 specifically define a “Sequence Listing.”

Section 1.831: Section 1.831 is added to provide the heading of “requirements for patent applications filed on or after July 1, 2022, having disclosures of nucleotide and/or amino acid sequences.”

Section 1.831(a) is added to specify that patent applications disclosing nucleotide and/or amino acid sequences by enumeration of their residues, as defined in paragraph (b) of the section, must contain, as a separate part of the disclosure, a “Sequence Listing XML”. Disclosed nucleotide and/or amino acid sequences that do not meet the definition in paragraph (b) of the section must not be included in the “Sequence Listing XML.” The “Sequence Listing XML” contains information of the nucleotide and/or amino acid sequences disclosed in the patent application using the symbols and format in accordance with the requirements of §§ 1.832 through 1.834.

Section 1.831(b)(1) and (2) are added to define the nucleotide and amino acid sequences for which a “Sequence Listing XML” is required. Specifically, nucleotide and/or amino acid sequences, as used in these rules, encompass: an unbranched sequence or linear region of a branched sequence containing 4 or more specifically defined amino acids, wherein the amino acids form a single peptide backbone or an unbranched sequence or linear region of a branched sequence of 10 or more specifically defined nucleotides, wherein adjacent nucleotides are joined by a 3′ to 5′ (or 5′ to 3′) phosphodiester linkage or, for nucleotide analogs, any chemical bond that results in an arrangement of adjacent nucleobases that mimics the arrangement of nucleobases in naturally occurring nucleic acids.

Section 1.831(c) is added to state that, where the description or claims of a patent application discuss a nucleotide and/or amino acid sequence that is set forth in the “Sequence Listing XML” in accordance with paragraph (a) of the section, reference must be made to the sequence by use of the sequence identifier, preceded by “SEQ ID NO:” or the like, in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application. Where a sequence is presented in a drawing, reference must be made to the sequence by use of the sequence identifier (§ 1.832(a)), either in the drawing or in the Brief Description of the Drawings, where the correlation between multiple sequences in the drawing and their sequence identifiers (§ 1.832(a)) in the Brief Description is clear. The use of SEQ ID NO: Is preferred, but including “or the like” is intended to ensure that a formalities notice is not sent when an application uses, for example, “SEQ NO.” or “Seq. Id. No.” or any similar identification of an amino acid or nucleotide sequence in the description or claims where it is clear that a sequence from the “Sequence Listing XML” is shown in the description, claims, or drawings. When identifying the sequence in the description, claims, or drawings, the numeric sequence identifier from the “Sequence Listing XML” must identify the same sequence.

Section 1.831(d) is added to define the expression “enumeration of its residues,” consistent with the definition in paragraph 3(c)(i) or (ii) of WIPO Standard ST.26 (incorporated by reference, see 37 CFR 1.839).

Section 1.831(e) is added to define the expression “specifically defined,” consistent with the definition in paragraph 3(k) of WIPO Standard ST.26.

Section 1.831(f) is added to define the expression “amino acid,” consistent with the definition in paragraph 3(a) of WIPO Standard ST.26.

Section 1.831(g) is added to define the expression “modified amino acid,” consistent with the definition in paragraph 3(e) of WIPO Standard ST.26.

Section 1.831(h) is added to define the expression “nucleotide,” consistent with paragraphs 3(f) and 3(g) of WIPO Standard ST.26.

Section 1.831(i) is added to define the expression “modified nucleotide,” consistent with paragraph 3(f) of WIPO Standard ST.26.

Section 1.831(j) is added to indicate that a “Sequence Listing XML” must not include any sequences having fewer than 10 specifically defined nucleotides, or fewer than 4 specifically defined amino acids. Even though § 1.831(a) states that “[d]isclosed nucleotide or amino acid sequences that do not meet the definition in paragraph (b) of this section must not be included in the “Sequence Listing XML,” ” adding § 1.831(j) makes explicit the prohibition of including such sequences in the “Sequence Listing XML.”

Section 1.832: Section 1.832 is added to provide the manner in which a nucleotide and/or amino acid sequence is represented in the “Sequence Listing XML” part of a patent application having a filing date on or after July 1, 2022.

Section 1.832(a) is added to define the requirements for the representation of sequences in the “Sequence Listing XML” part of the application. Specifically, each nucleotide and/or amino acid sequence represented in the “Sequence Listing XML” must be assigned a separate sequence identifier, and sequence identifiers must begin with the number 1 and increase sequentially by integers, as defined in paragraph 10 of WIPO Standard ST.26 (incorporated by reference, see 37 CFR 1.839).

Section 1.832(b)(1) through (4) are added to define the requirements for the representation of nucleotide sequence data in the “Sequence Listing XML.” Specifically, a nucleotide sequence must be represented in the manner described in paragraphs 11-12 of WIPO Standard ST.26. All nucleotides, including nucleotide analogs, modified nucleotides, and “unknown” nucleotides, within a nucleotide sequence must be represented and described using symbols in the manner described in paragraphs 13-19 and 21 of WIPO Standard ST.26. For a region containing a known number of contiguous “a,” “c,” “g,” “t,” or “n” residues for which the same description applies, the entire region may be jointly described as provided in paragraph 22 of WIPO Standard ST.26.

Section 1.832(c)(1) through (4) are added to define the requirements for the representation of amino acid sequence data in the “Sequence Listing XML.” Specifically, an amino acid sequence must be represented in the manner described in paragraphs 24 and 25 of WIPO Standard ST.26. All amino acids, including modified amino acids and “unknown” amino acids, within an amino acid sequence must be represented and described using symbols in the manner described in paragraphs 26-30 and 32 of WIPO Standard ST.26. For a region containing a known number of contiguous “X” residues for which the same description applies, the entire region may be jointly described as provided in paragraph 34 of WIPO Standard ST.26.

Section 1.832(d) is added to define the manner in which a single continuous sequence, derived from one or more non-contiguous segments of a larger sequence, or of segments from different sequences, must be represented in the “Sequence Listing XML,” as described in paragraph 35 of WIPO Standard ST.26.

Section 1.832(e) is added to define the manner in which a nucleotide and/or amino acid sequence that contains regions of specifically defined residues separated by one or more regions of contiguous “n” or “X” residues of specified length must be represented in the “Sequence Listing XML,” as described in paragraph 36 of WIPO Standard ST.26.

Section 1.832(f) is added to define the manner in which a nucleotide and/or amino acid sequence that contains regions of specifically defined residues separated by one or more gaps of an unknown or undisclosed number of residues must be represented in the “Sequence Listing XML,” as described in paragraph 37 of WIPO Standard ST.26.

Section 1.833: Section 1.833 is added to describe the requirements for a “Sequence Listing XML,” which is required by § 1.831(a) for disclosures of nucleotides and/or amino acid sequences in patent applications with a filing date on or after July 1, 2022, to comply with WIPO Standard ST.26 (incorporated by reference, see 37 CFR 1.839).

Section 1.833(a) is added to require that the “Sequence Listing XML” must be presented as a single XML 1.0 file and encoded using Unicode UTF-8. Section 1.833(a) also incorporates by reference paragraphs 40 and 41, and Annex IV of WIPO Standard ST.26 for character sets.

Section 1.833(b)(1) is added to require that the “Sequence Listing XML” presented in accordance with § 1.833(a) must further be valid according to the DTD as presented in Annex II of WIPO Standard ST.26.

Section 1.833(b)(2) is added to recite that a “Sequence Listing XML” must comply with the requirements of WIPO Standard ST.26, to include the items enumerated in § 1.833(b)(2)(i) through (v) as discussed in the following paragraphs.

Section 1.833(b)(2)(i) is added to require that the “Sequence Listing XML” contain an XML declaration as defined in paragraph 39(a) of WIPO Standard ST.26.

Section 1.833(b)(2)(ii) is added to require that the “Sequence Listing XML” contain a document type declaration as defined in paragraph 39(b) of WIPO Standard ST.26.

Section 1.833(b)(2)(iii) is added to require that the “Sequence Listing XML” contain a root element as defined in paragraph 43 of WIPO Standard ST.26.

Section 1.833(b)(2)(iv) is added to require that the “Sequence Listing XML” contain a general information part that complies with paragraphs 45, 47, and 48 of WIPO Standard ST.26, as applicable.

Section 1.833(b)(2)(v) is added to require that the “Sequence Listing XML” contain a sequence data part that complies with paragraphs 50-55, 57, 58, 60-69, 71-78, 80-87, 89-98, and 100 of WIPO Standard ST.26, as applicable.

Section 1.833(b)(3) is added to require that an INSDQualifier_value element includes a value for that element in English for each language-dependent free text qualifier in the “Sequence Listing XML,” as required by § 1.52(b)(1)(ii), and where an INSDQualifier_value element is defined in paragraphs 76 and 85-87 of WIPO Standard ST.26. The proposed requirement for a translation of the title into English was not adopted in the final rule because applicants in the international phase need only provide a title in the language of filing, which can be in a language other than English.

Section 1.834: Section 1.834 is added to provide details on the form and format for nucleotide and/or amino acid sequence submissions as the “Sequence Listing XML” in patent applications filed on or after July 1, 2022.

Section 1.834(a) is added to indicate that a “Sequence Listing XML” in Unicode UTF-8 created by any means ( e.g., text editors, nucleotide/amino acid sequence editors, or other custom computer programs) in accordance with §§ 1.831 through 1.833 must: (1) Be compatible with a PC or Mac® and with MS-DOS®, MS-Windows®, Mac OS®, or Unix®/Linux® operating systems; (2) be in XML format, where all permitted printable characters (including the space character) and non-printable (control) characters are defined in paragraph 40 of WIPO Standard ST.26 (incorporated by reference, see 37 CFR 1.839); and (3) be named as *.xml, where “*” is one character or a combination of characters limited to upper- or lowercase letters, numbers, hyphens, and underscores and the name does not exceed 60 characters in total, excluding the extension. No spaces or other types of characters are permitted in the file name.

Section 1.834(b) is added to require that the “Sequence Listing XML” must be in a single file containing the sequence information and be submitted either: (1) Electronically via the USPTO patent electronic filing system, where the file size must not exceed 100 MB and file compression is not permitted; or (2) on read-only optical disc(s) in compliance with § 1.52(e), where (i) a file that is not compressed must be contained on a single read-only optical disc, (ii) the file may be compressed using WinZip®, 7-Zip, or Unix®/Linux® Zip, (iii) a compressed file must not be self-extracting, and (iv) a compressed XML file that does not fit on a single read-only optical disc may be split into multiple file parts in accordance with the target read-only optical disc size and labeled in compliance with § 1.52(e)(5)(vi).

Section 1.834(c)(1) is added to require that when a “Sequence Listing XML” required by § 1.831(a) is submitted in XML file format via the USPTO patent electronic filing system or on a read-only optical disc (in compliance with § 1.52(e)), the specification must contain a statement in a separate paragraph ( see § 1.77(b)(5)) that incorporates by reference the material in the XML file identifying: (1) The name of the file, (2) the date of creation, and (3) the size of the file in bytes, so long as § 1.834(c)(2) does not apply. This provision was added in the final rule to expressly require an incorporation by reference statement in the specification to the “Sequence Listing XML,” which was only implicitly required by § 1.835(c).

Section 1.834(c)(2) is added to indicate that if the “Sequence Listing XML” required by § 1.831(a) is submitted in XML file format via the USPTO patent electronic filing system or on a read-only optical disc (in compliance with § 1.52(e)) for an international application during the international stage, then an incorporation by reference statement of the material in the XML file is not required. This provision was added in the final rule to specifically exempt the requirement for an incorporation by reference statement in the specification to the “Sequence Listing XML” (as in § 1.834(c)(1)) for a national stage application when the “Sequence Listing XML” constituted part of the international application during the international stage.

Section 1.835: Section 1.835 is added to provide the requirements for submission of an amendment to add or replace a “Sequence Listing XML” for applications filed on or after July 1, 2022.

Section 1.835(a) is added to require that any amendment to a patent application adding an initial submission of a “Sequence Listing XML” as required by § 1.831(a) after the application filing date must include: (1) A “Sequence Listing XML” file submitted either (i) via the USPTO patent electronic filing system, or (ii) on a read-only optical disc in compliance with § 1.52(e); (2) a request to amend the specification to include an incorporation by reference statement of the material in the “Sequence Listing XML” file, identifying the name of the file, the date of creation, and the size of the file in bytes ( see § 1.77(b)(5)(ii)), except when submitted to the United States International Preliminary Examining Authority for an international application; (3) a statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed (specification, claims, drawings) for all sequence data in the “Sequence Listing XML”; and (4) a statement that the “Sequence Listing XML” includes no new matter.

Section 1.835(b) is added to require that any amendment adding to, deleting from, or replacing sequence information in a “Sequence Listing XML” submitted as required by § 1.831(a) must include: (1) A replacement “Sequence Listing XML” containing the entire “Sequence Listing XML,” including any additions, deletions, or replacements of sequence information, and shall be submitted either (i) via the USPTO patent electronic filing system, or (ii) on a read-only optical disc, in compliance with § 1.52(e) labeled as “REPLACEMENT MM/DD/YYYY” (with the month, day, and year of creation indicated); (2) an instruction to amend the specification to include an incorporation by reference statement of the material in the replacement “Sequence Listing XML” file that identifies the name of the file, the date of creation, and the size of the file in bytes ( see § 1.77(b)(5)(ii)), except when the replacement “Sequence Listing XML” is submitted to the United States International Preliminary Examining Authority for an international application; (3) a statement that identifies the location of all additions, deletions, or replacements of sequence information relative to the replaced “Sequence Listing XML”; (4) a statement that indicates the support for the additions, deletions, or replacements of the sequence information, with specific references to particular parts of the application as originally filed (specification, claims, drawings) for all amended sequence data in the replacement “Sequence Listing XML”; and (5) a statement that the replacement “Sequence Listing XML” includes no new matter.

Section 1.835(c) is added to require that the specification of a complete application with a “Sequence Listing XML” as required under § 1.831(a), present on the application filing date but without an incorporation by reference of the material contained in the “Sequence Listing XML” file, must be amended to contain a separate paragraph incorporating by reference the material contained in the “Sequence Listing XML” file, in accordance with § 1.77(b)(5)(ii), except for international applications.

Section 1.835(d)(1) is added to provide that, when any of the requirements of §§ 1.831 through 1.834 are not satisfied in an application under 35 U.S.C. 111(a) or in a national stage application under 35 U.S.C. 371, the applicant will be notified and given a period of time in which to comply with such requirements to prevent the abandonment of the application. This final rule indicates that, subject to § 1.835(d)(2), any amendment to add or replace a “Sequence Listing XML” in response to a requirement under this paragraph must be submitted in accordance with the requirements of § 1.835(a) through (c).

Section 1.835(d)(2) is added to explicitly provide that compliance with § 1.835(a) through (c) is not required for the submission of a “Sequence Listing XML” that is solely an English translation of a previously submitted “Sequence Listing XML” that contains non-English values for any language-dependent free text elements (as per § 1.833(b)(3)). The required submission will be a translated “Sequence Listing XML” in compliance with §§ 1.831 through 1.834. Updated values for attributes in the root element (§ 1.833(b)(2)(iii)) or elements of the general information part (§ 1.833(b)(2)(iv)) are not considered amendments for purposes of complying with § 1.835(a) through (c). Even though §§ 1.52(b)(1)(ii) and 1.495(c)(1)(i) require a translation for applications filed under 35 U.S.C. 111(a) and for those entering the national stage, respectively, this rule makes explicit that when a translated “Sequence Listing XML” is provided as a reply to a notice that the “Sequence Listing XML” contains non-English values for any language-dependent free text elements, and the translation does not include the deletion, addition, or replacement of sequence information, the translated “Sequence Listing XML” need not comply with the requirements for an amended “Sequence Listing XML” as set forth in § 1.835(a) through (c). The proposed requirement for a translation of the title into English was not adopted in the final rule because applicants in the international phase need only provide a title in the language of filing, which can be in a language other than English.

Section 1.835(e) is added to provide that, when any of the requirements of §§ 1.831 through 1.834 are not satisfied at the time of filing an international application under the PCT, where the application is to be searched by the United States International Searching Authority or examined by the United States International Preliminary Examining Authority, the applicant may be sent a notice calling for compliance with the requirements within a prescribed time period. Under PCT Rule 13 ter, the applicant may provide, in response to such a requirement or otherwise, a sequence listing that is a “Sequence Listing XML” in accordance with § 1.831(a). The “Sequence Listing XML” must be accompanied by a statement that the information recorded does not go beyond the disclosure in the international application as filed. In response to such a requirement, the late furnishing fee set forth in § 1.445(a)(5) is also required. If the applicant fails to timely provide the required “Sequence Listing XML,” the United States International Searching Authority shall search only to the extent that a meaningful search can be performed without the “Sequence Listing XML,” and the United States International Preliminary Examining Authority shall examine only to the extent that a meaningful examination can be performed without the “Sequence Listing XML.”

Section 1.835(f) is added to provide that any appropriate amendments to the “Sequence Listing XML” in a patent ( e.g., by reason of reissue, reexamination, or certificate of correction) must comply with the requirements of paragraph (b) of this section.

Section 1.839: Section 1.839 is added to provide the location of WIPO Standard ST.26 that is being incorporated by reference.

The USPTO published a proposed rule on July 6, 2021, at 86 FR 35432, soliciting public comments on the proposed amendments to 37 CFR part 1 being adopted in this final rule. The USPTO received no comments from the public on the proposed rule. Even though no comments were received, the proposed changes to §§ 1.495(c)(5), 1.833(b)(3) and 1.835(d)(2) to require a title in English in the “Sequence Listing XML” were not adopted in the final rule. The proposed requirement for a translation of the title into English was not adopted since applicants in the international phase need only provide a title in the language of filing, which can be in a language other than English. Additionally, even though § 1.831(a) states that “[d]isclosed nucleotide or amino acid sequences that do not meet the definition in paragraph (b) of this section must not be included in the “Sequence Listing XML,” ” § 1.831(j) was added to make explicit the prohibition of including such sequences in the “Sequence Listing XML.” Section 1.834(c)(1) was added to expressly require an incorporation by reference statement in the specification to the “Sequence Listing XML,” which was only implicitly required by § 1.835(c). Lastly, § 1.834(c)(2) was added to specifically exempt the requirement for an incorporation by reference statement in the specification to the “Sequence Listing XML” (as in § 1.834(c)(1)) for a national stage application when the “Sequence Listing XML” constituted part of the international application during the international stage.

A. Administrative Procedure Act: The changes in this rulemaking involve rules of agency practice and procedure, and/or interpretive rules. See Bachow Commc'ns Inc. v. FCC, 237 F.3d 683, 690 (D.C. Cir. 2001) (changes to procedural rules are not subject to notice and comment review under the Administrative Procedure Act (APA)); Inova Alexandria Hosp. v. Shalala, 244 F.3d 342, 349 (4th Cir. 2001) (rules for handling appeals are procedural where they do not change the substantive standard for reviewing claims); Nat'l Org. of Veterans' Advocates v. Sec'y of Veterans Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 2001) (Substantive rules “effect a change in existing law or policy or which affect individual rights and obligations,” whereas interpretative rules “clarify or explain existing law or regulation and are exempt from notice and comment” review under the APA.).

Accordingly, prior notice and opportunity for public comment for the changes in this rulemaking were not required pursuant to 5 U.S.C. 553(b) or (c), or any other law. See 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))). However, the USPTO chose to seek public comment before implementing the rule to benefit from the public's input.

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

The USPTO amends the rules of practice to require the submission of biological sequence data in XML where the rules of practice incorporate by reference WIPO Standard ST.26, “Recommended Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings Using XML (eXtensible Markup Language),” including Annexes I-VII, version 1.5, approved November 5, 2021, as disclosed in the WIPO Handbook on Industrial Property Information and Documentation.

This rulemaking makes more technical data associated with biotechnology inventions available to the public because the new rules of practice based on WIPO Standard ST.26 provide for enhanced biological sequence data related to disclosures of nucleotide and/or amino acid sequences in patent applications. WIPO Standard ST.26 provides clear rules as to what must be included in a sequence listing and how sequences must be represented ( e.g., standardization of the representation of modified nucleic acids and amino acids as well as variants derived from primary sequences). WIPO Standard ST.26 contains a guidance document that demonstrates the requirement for inclusion and representation of biological sequence data. As a result, patent applicants will have a clearer understanding as to the requirements and presentation of biological sequence data in a compliant sequence listing under WIPO Standard ST.26. Additionally, since WIPO Standard ST.26 only allows XML format, applicants will not be burdened with or confused by the requirements of filing a sequence listing in paper or PDF format, and IPOs will not be burdened with processing paper sequence listings and performing necessary checks on the contents of the paper documents. The changes in this rulemaking are largely procedural in nature, and do not impose any additional requirements or fees on applicants. For the foregoing reasons, the changes in this rule will not have a significant economic impact on a substantial number of small entities.

C. Executive Order 12866 (Regulatory Planning and Review): This rulemaking has been determined to be not significant for purposes of Executive Order 12866 (Sept. 30, 1993).

D. Executive Order 13563 (Improving Regulation and Regulatory Review): The USPTO has complied with Executive Order 13563 (Jan. 18, 2011). Specifically, to the extent feasible and applicable, the USPTO has: (1) Reasonably determined that the benefits of the rule justify its costs; (2) tailored the rule to impose the least burden on society consistent with obtaining the agency's 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 while maintaining flexibility and freedom of choice for the public; and (9) ensured the objectivity of scientific and technological information and processes.

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

F. Executive Order 13175 (Tribal Consultation): 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 Executive Order 13175 (Nov. 6, 2000).

G. Executive Order 13211 (Energy Effects): This rulemaking is not a significant energy action under Executive Order 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 Executive Order 13211 (May 18, 2001).

H. Executive Order 12988 (Civil Justice Reform): 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 Executive Order 12988 (Feb. 5, 1996).

I. Executive Order 13045 (Protection of Children): This rulemaking does not concern an environmental risk to health or safety that may disproportionately affect children under Executive Order 13045 (Apr. 21, 1997).

J. Executive Order 12630 (Taking of Private Property): This rulemaking will not affect a taking of private property or otherwise have taking implications under Executive Order 12630 (Mar. 15, 1988).

K. Congressional Review Act: 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 United States Senate, the United States 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 United States-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).

L. Unfunded Mandates Reform Act of 1995: The changes set forth 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.

M. National Environmental Policy Act of 1969: 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.

N. National Technology Transfer and Advancement Act of 1995: 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.

O. Paperwork Reduction Act of 1995: The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3549) requires that the USPTO consider the impact of paperwork and other information collection burdens imposed on the public. In accordance with section 3507(d) of the Paperwork Reduction Act of 1995, the majority of the paperwork and other information collection burdens discussed in this rule have already been approved under the following Office of Management and Budget (OMB) Control Numbers: 0651-0024 (Sequence Listing), 0651-0031 (Patent Processing), 0651-0032 (Initial Patent Applications), and 0651-0064 (Patent Reexaminations and Supplemental Examinations).

Modifications to 0651-0024 because of this rulemaking will be submitted to OMB for approval. Modifications include the removal of the Sequence Listing in Application (paper), which will result in an estimated reduction in the burden associated with this information collection by 5,000 responses and 30,000 burden hours. These burden estimates are based on the current OMB approved burdens (response volumes) associated with this information collection, which may be different from any forecasts mentioned in other parts of this rule.

The changes discussed in this rule do not affect the information collection requirements or burdens associated with 0651-0031, 0651-0032, and 0651-0064 listed above; therefore, the USPTO does not plan to take any additional actions on these information collections as a result of this rulemaking. 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.

P. E-Government Act Compliance: 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 stated in the preamble and under the authority contained in 35 U.S.C. 2, as amended, the USPTO amends 37 CFR part 1 as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

On March 3, 2022 (87 FR 12033), EPA proposed to determine that the Indiana portion of the Chicago-Naperville, IL-IN-WI area is attaining the 2008 ozone NAAQS, and that the State has met the statutory requirements for redesignation under the CAA. EPA proposed to approve, as a revision to the Indiana SIP, the State's plan for maintaining the 2008 ozone NAAQS through 2035 for the Indiana portion. EPA also proposed to approve a waiver, for the Indiana portion of the Chicago area, from the NO X requirements of section 182(f) of the CAA. EPA proposed to approve and find adequate Indiana's 2030 and 2035 VOC and NO X motor vehicle emissions budgets for the Indiana portion of the Chicago area. EPA proposed to approve the VOC RACT, the CFVP, and the EMP. Finally, EPA proposed to approve the State's enhanced I/M certification, because it satisfies the enhanced I/M requirements for “serious areas” for the Indiana portion of the Chicago area. The public comment period for this proposed rule ended on April 4, 2022. EPA received one supportive comment on the proposed redesignation. EPA also received adverse comments on the proposal from the Wisconsin Department of Natural Resources (WDNR). These comments will be addressed below.

On April 8, 2022, Indiana submitted new on-road emissions inventory information, which the State generated using EPA's MOVES3 model. Indiana requested that the new MOVES3 inventory information should replace the MOVES2014 emissions inventory, motor vehicle emissions budgets, and I/M performance standard modeling analysis that were included in the State's December 6, 2021 submission. MOVES3 is the latest MOVES version and is EPA's state-of-the-art model for estimating emissions from on-road mobile sources. 1 Consistent with our proposal based on the MOVES2014 modeling, the projected emissions inventory for 2035 incorporating the updated MOVES3 budgets demonstrates maintenance of the 2008 ozone NAAQS through the 2035 maintenance period. The MOVES3 I/M performance standard demonstration is consistent with the findings in EPA's proposal and supports Indiana's certification that its current I/M program in Lake and Porter counties meets the applicable Enhanced I/M performance standard requirements in 40 CFR part 51, subpart S for the 2008 ozone NAAQS. With this additional MOVES3 information, EPA has determined that the Indiana portion of the Chicago area has met the requirements for redesignation under section 107(d)(3)(E) of the CAA.

Below are the revised emissions data tables that contain the new on-road emissions inventory information from MOVES3. Tables 1 and 2 contain emissions with changes in VOC and NO X emissions from 2011 to 2019 for the Indiana portion of the Chicago area.

As shown in Tables 1 and 2, NO X and VOC emissions in the Indiana portion of the Chicago area declined by 63.57 tons/day and 27.71 tons/day, respectively, between 2011 and 2019. NO X and VOC emissions throughout the entire Chicago area declined by 316.52 tons/day and 55.32 tons/day, respectively, between 2011 and 2019.

Projected emissions data are shown in Tables 3 and 4 below.

Table 5 contains the NOx and VOC motor vehicle budgets for the Indiana portion of the Chicago area for 2030 and 2035. The budgets include a 15% margin of safety applied to NO X and VOC emission estimates for both years.

EPA provided a 30-day review and comment period for the March 3, 2022, proposed rule. The comment period ended on April 4, 2022. We received one supportive comment on the proposed redesignation. We also received adverse comments from WDNR requesting that EPA not approve the NO X RACT waiver. These comments are summarized and addressed below.

Comment 1: A NO X RACT program was required for the three-state Chicago-Naperville 2008 ozone nonattainment area by January 1, 2017, after the area was reclassified to moderate. In response to this requirement, Indiana submitted several NO X RACT waiver requests: The first in February 2017, the second in January 2020, and the third in January 2022. The Chicago nonattainment area did not attain the 2008 ozone standard in the 2019 ozone season and was reclassified to serious in August 2019. The Chicago nonattainment area briefly attained after the 2019 ozone season, but then violated the standard in 2020. The commenter states that this action is in response to Indiana's third NO X waiver request, which was submitted in January 2022. The commenter argues that EPA's delayed decision-making means Indiana is now 5 years overdue in implementing the CAA required NO X RACT program.

Response: CAA section 182(f)(1)(A) provides that the plan provisions to address RACT for major stationary sources of NO X for nonattainment areas not within an ozone transport region do not apply if EPA determines “that additional reductions of [NO X ] would not contribute to attainment of the national ambient air quality standard for ozone in the area.” The Chicago area is attaining the 2008 ozone NAAQS, based on the most recent certified monitoring data from the 2019-2021 period. It is EPA's longstanding interpretation, as stated in EPA's January 2005 document, “Guidance on Limiting Nitrogen Oxides Requirements Related to 8-Hour Ozone Implementation,” that when an ozone nonattainment area is attaining the ozone standard, as demonstrated by three consecutive years of adequate monitoring data, “it is clear that the section 182(f)[(1)(A)] language is met since `additional reductions of oxides of nitrogen would not contribute to attainment.' That is, since attainment has already occurred, additional NO X reductions could not improve the area's attainment status and, therefore, the NO X exemption request could be approved.”

EPA never acted on the waiver request submitted in February 2017 and, the waiver was withdrawn by IDEM in January 2020. Also, EPA never acted on the waiver request submitted in January 2020 and, that waiver was withdrawn by IDEM in November 2021. The NO X RACT waiver under consideration in this action was submitted by IDEM in January 2022 and is based on CAA section 182(f)(1)(A). This waiver can be approved because the area qualifies for the NO X RACT waiver due to the achievement of three years of clean monitoring data.

Comment 2: The implementation of NO X RACT is a cost-effective way to address ozone-forming compounds from stationary sources and NO X RACT technologies are widely available. Wisconsin has a fully approved NO X RACT program and Illinois implements a NO X emissions control program. Given this information, the commenter argues that there are no barriers in preventing the implementation of a NO X RACT program in Indiana.

Response: The Chicago area is attaining the 2008 ozone NAAQS, based on the most recent certified monitoring data from the 2019-2021 period. EPA is finalizing our approval of the NO X RACT waiver because as per the discussion above regarding the CAA section 182(f)(1)(A) the area qualifies for the NO X RACT waiver due to the achievement of three years of clean monitoring data. The fact that other states (Wisconsin and Illinois) have implemented NO X controls on stationary sources has no bearing on the availability of this waiver under the CAA.

Comment 3: The Chicago nonattainment area continues to struggle to meet Federal ozone standards. The Chicago area has failed to meet its August 3, 2021, marginal attainment date for the more stringent 2015 ozone standard. The commenter further states that EPA is overdue in meeting its statutory obligation to reclassify this area to moderate for the 2015 standard, which was due within 6 months of that attainment date. When this reclassification to moderate under the 2015 ozone standard is finalized, Indiana will be required to submit a NO X RACT program under the CAA. Given this forthcoming NO X RACT requirement, the commenter argues EPA's proposed approval to waive an emissions control requirement that will soon be reinstated by statute should not be granted.

Response: In this action, EPA is granting a NO X RACT waiver only for the 2008 ozone standard based on three years of clean monitoring data for that standard. A CAA section 182(f) NO X exemption granted for the 2008 ozone standard does not relieve the area from any CAA section 182(f) NO X obligations under the 2015 ozone NAAQS ( see 40 CFR 51.1313(c)). Therefore, a potential future reclassification of the Chicago area under the 2015 ozone standard does not prevent EPA from approving the NO X RACT waiver for the 2008 ozone standard.

Comment 4: The CAA does not compel EPA to grant this waiver request and that the approval of the NO X waiver relies on EPA's 2005 guidance. In EPA's 2005 guidance, EPA cautions that actions relying on the guidance might not be approvable in every situation. The commenter requests that EPA explain how it is appropriate to apply that guidance when the Chicago area remains in nonattainment for ozone and needs additional NO X emissions reductions in the area to meet all of the ozone standards.

Response: The Chicago area is attaining the 2008 ozone NAAQS, based on the most recent certified monitoring data from the 2019-2021 period. In this action, EPA is granting a NO X RACT waiver only for the 2008 ozone standard because, as per the discussion above regarding the CAA section 182(f)(1)(A) and EPA's January 2005 document, the area qualifies for the NO X RACT waiver due to the achievement of three years of clean monitoring data. A CAA section 182(f) NO X exemption granted for the 2008 standard does not relieve the area from any CAA section 182(f) NO X obligations under the 2015 ozone NAAQS (see 40 CFR 51.1313(c)). Therefore, approval of a NO X RACT waiver only as it applies to the 2008 ozone NAAQS is appropriate.

Comment 5: EPA's recently released ozone transport modeling for the 2015 standard shows that Indiana significantly contributes to downwind nonattainment at several monitors along Wisconsin's Lake Michigan shoreline. Also, both the Sheboygan and Chicago nonattainment areas will continue to be nonattainment for the 2015 ozone standard in 2032 based on EPA's ozone transport modeling. Given these modeling results, the commenter states that additional, timely reductions in ozone precursor emissions, including NO X, are needed to ensure attainment of the 2015 ozone standard throughout the region.

Response: The Chicago area is attaining the 2008 ozone NAAQS, based on the most recent certified monitoring data from the 2019-2021 period. In this action, EPA is finalizing our approval of the NO X RACT waiver only for the 2008 ozone standard because, as discussed above regarding the CAA section 182(f)(1)(A), the area qualifies for the NO X RACT waiver based on three years of clean monitoring data and EPA's modeling indicates that the Chicago area will continue to attain the 2008 NAAQS in the future. In this regard, further NO X reductions will not improve the area's ability to attain the 2008 ozone standard. In contrast, EPA's ozone transport modeling indicates that, barring further emissions reductions, this area will continue to have difficulty attaining or maintaining the 2015 NAAQS in 2024 (the Moderate Area attainment date for the 2015 NAAQS) and beyond. CAA section 182(f) NO X exemption granted for a prior ozone standard (in this case the 2008 standard) does not relieve the area from any CAA section 182(f) NO X obligations under the 2015 ozone NAAQS ( see 40 CFR 51.1313(c)). If finalized, EPA's determination that the Chicago area failed to attain the 2015 ozone NAAQS by the attainment date and accompanying reclassification to Moderate would impose the CAA's NO X RACT requirements for the 2015 ozone standard.

EPA is determining that the Chicago area is attaining the 2008 ozone NAAQS, based on quality-assured and certified monitoring data for 2019-2021. EPA is approving Indiana's January 18, 2022, NO X exemption request as meeting section 182(f) requirements of the CAA. EPA is approving the VOC RACT, CFVP, EMP, and Enhanced I/M program SIP revisions included in Indiana's December 29, 2020, and January 18, 2022, submittals, because they satisfy the Serious requirements of the CAA for the Indiana portion of the Chicago area. EPA has determined that the Indiana portion of the Chicago area has met the requirements for redesignation under section 107(d)(3)(E) of the CAA. EPA is thus changing the legal designation of the Indiana portion of the Chicago-Naperville, IL-IN-WI area from nonattainment to attainment for the 2008 ozone NAAQS. EPA is also approving, as a revision to the Indiana SIP, the state's maintenance plan for the area. The maintenance plan is designed to keep the Indiana portion of the Chicago area in attainment of the 2008 ozone NAAQS through 2035. Finally, EPA is finding adequate and is approving the newly established 2030 and 2035 motor vehicle emissions budgets for transportation conformity purposes in the Indiana portion of the Chicago area.

In accordance with 5 U.S.C. 553(d) of the Administrative Procedure Act (APA), EPA finds there is good cause for this action to become effective immediately upon publication. The immediate effective date for this action is authorized under 5 U.S.C. 553(d)(1).

Section 553(d)(1) of the APA provides that final rules shall not become effective until 30 days after publication in the Federal Register “except . . . a substantive rule which grants or recognizes an exemption or relieves a restriction.” The purpose of this provision is to “give affected parties a reasonable time to adjust their behavior before the final rule takes effect.” Omnipoint Corp. v. Fed. Commc'n Comm'n , 78 F.3d 620, 630 (D.C. Cir. 1996); see also United States v. Gavrilovic , 551 F.2d 1099, 1104 (8th Cir. 1977) (quoting legislative history). However, when the agency grants or recognizes an exemption or relieves a restriction, affected parties do not need a reasonable time to adjust because the effect is not adverse. EPA has determined that this rule relieves a restriction because this rule relieves sources in the area of Nonattainment New Source Review (NNSR) permitting requirements; instead, upon the effective date of this action, sources will be subject to less restrictive Prevention of Significant Deterioration (PSD) permitting requirements. For this reason, EPA finds good cause under 5 U.S.C. 553(d)(1) for this action to become effective on the date of publication of this action.

Under the CAA, redesignation of an area to attainment and the accompanying approval of a maintenance plan under section 107(d)(3)(E) are actions that affect the status of a geographical area and do not impose any additional regulatory requirements on sources beyond those imposed by state law. A redesignation to attainment does not in and of itself create any new requirements, but rather results in the applicability of requirements contained in the CAA for areas that have been redesignated to attainment. Moreover, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For these reasons, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

This action is subject to the Congressional Review Act, 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).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 19, 2022. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

For the reasons stated in the preamble, 40 CFR parts 52 and 81 are amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

On March 10, 2022 (87 FR 13668), EPA proposed to find that the Illinois portion of the Chicago area is attaining the 2008 ozone NAAQS and to act in accordance with a January 25, 2022, request from Illinois to redesignate the Illinois portion of the Chicago area to attainment for the 2008 ozone NAAQS because the request meets the statutory requirements for redesignation under the CAA. EPA proposed to approve, as a revision to the Illinois SIP, the State's plan for maintaining the 2008 ozone NAAQS through 2035 in the Illinois portion of the Chicago area. EPA proposed to find adequate and approve the 2035 VOC and NO X motor vehicle emission budgets (budgets) for the Illinois portion of the Chicago area. Pursuant to section 110 and part D of the CAA, EPA proposed to approve the VOC RACT, Enhanced I/M, the CFVP, and the EMP SIP revisions submitted by Illinois, because they satisfy serious SIP requirements of the CAA for the Illinois portion of the Chicago area. Finally, EPA proposed to approve a CAA section 182(f) waiver from NO X RACT requirements for the Illinois portion of the Chicago area under the 2008 ozone NAAQS. An explanation of CAA requirements, a detailed analysis of how these requirements apply to the Illinois portion of the Chicago area, a discussion of how Illinois has met these requirements, and EPA's reasons for proposing these actions were provided in the notice of proposed rulemaking and will not be restated here.

EPA provided a 30-day review and comment period for the March 10, 2022, proposed rule. The comment period ended on April 11, 2022. We received one adverse comment from the Wisconsin Department of Natural Resources (WDNR) on our proposed approval of the CAA section 182(f) waiver from NO X RACT requirements. The adverse comment is summarized and addressed below.

Comment 1: WDNR requested that EPA not approve the NO X RACT waiver for the following reasons:

Comment 1a: The commenter states that a NO X RACT program was required for the three-state Chicago-Naperville 2008 ozone nonattainment area by January 1, 2017, after the area was reclassified to moderate. While Illinois has a NO X program, it is not federally approved and does not fully meet all NO X RACT requirements.

Response 1a: CAA section 182(f)(1)(A) provides that a state is not required to implement RACT for major stationary sources of NO X for nonattainment areas not within an ozone transport region if EPA determines “that additional reductions of [NO X ] would not contribute to attainment of the [NAAQS] for ozone in the area.” The Illinois portion of the Chicago area is attaining the 2008 ozone NAAQS, based on the most recent certified monitoring data from the 2019-2021 period. It is EPA's longstanding interpretation, as stated in EPA's January 2005 document, “Guidance on Limiting Nitrogen Oxides Requirements Related to 8-Hour Ozone Implementation,” that when an ozone nonattainment area is attaining the ozone standard, as demonstrated by three consecutive years of adequate monitoring data, “it is clear that the section 182(f)[(1)(A)] language is met since `additional reductions of oxides of nitrogen would not contribute to attainment.' That is, since attainment has already occurred, additional NO X reductions could not improve the area's attainment status and, therefore, the NO X exemption request could be approved.” The NO X RACT waiver under consideration in this action was submitted by Illinois on January 25, 2022, and is based on CAA section 182(f)(1)(A). This waiver can be approved because the area is attaining the 2008 ozone NAAQS, as demonstrated by the three years of clean monitoring data, and additional NO X reductions would not improve the area's attainment status.

Comment 1b: The commenter states that the Chicago nonattainment area continues to struggle to meet Federal ozone standards, such as by failing to meet its August 3, 2021, marginal attainment date for the more stringent 2015 ozone standard. The commenter further states that EPA is overdue in meeting its statutory obligation to reclassify this area to moderate for the 2015 ozone standard, which was due within 6 months of that attainment date. When the reclassification to moderate under the 2015 ozone standard is finalized, Illinois will be required to submit a NO X RACT program under the CAA. Given this forthcoming NO X RACT requirement, the commenter argues EPA's proposed approval to waive an emissions control requirement that will soon be reinstated by statute should not be granted.

Response 1b: In this action, EPA is granting a NO X RACT waiver only for the 2008 ozone standard based on three years of clean monitoring data for that standard. A CAA section 182(f) NO X exemption granted for a prior ozone standard (in this case the 2008 ozone standard) does not relieve the area from any CAA section 182(f) NO X obligations under the 2015 ozone NAAQS (see 40 CFR 51.1313(c)). Therefore, potential future reclassification of the Chicago area under the 2015 ozone standard does not prevent EPA from approving the NO X RACT waiver for the 2008 ozone standard.

Comment 1c: The commenter states that the CAA does not compel EPA to grant this waiver request and that the approval of the NO X waiver relies on EPA's 2005 guidance, in which EPA cautions that actions relying on the guidance might not be approvable in every situation. The commenter requests that EPA explain how it is appropriate to apply that guidance when the Chicago area remains in nonattainment for ozone and needs additional NO X emissions reductions in the area to meet all of the ozone standards.

Response 1c: The Chicago area is attaining the 2008 ozone NAAQS, based on the most recent certified monitoring data from the 2019-2021 period. In this action, EPA is granting a NO X RACT waiver only for the 2008 ozone standard because, as per the discussion above regarding the CAA section 182(f)(1)(A) and EPA's January 2005 document, the area qualifies for the NO X RACT waiver due to the achievement of three years of clean monitoring data. A CAA section 182(f) NO X exemption granted for the 2008 ozone standard does not relieve the area from any CAA section 182(f) NO X obligations under the 2015 ozone NAAQS (see 40 CFR 51.1313(c)). Therefore, approval of a NO X RACT waiver only as it applies to the 2008 ozone NAAQS is appropriate.

Comment 1d: The commenter states that EPA's recently released ozone transport modeling for the 2015 standard shows that Illinois significantly contributes to downwind nonattainment at several monitors along Wisconsin's Lake Michigan shoreline. Also, both the Sheboygan and Chicago nonattainment areas will continue to be nonattainment for the 2015 ozone standard in 2032 based on EPA's ozone transport modeling. Given these modeling results, the commenter states that additional, timely reductions in ozone precursor emissions, including NO X , are needed to ensure attainment of the 2015 ozone standard throughout the region.

Response 1d: The Illinois portion of the Chicago area is attaining the 2008 ozone NAAQS, based on the most recent certified monitoring data from the 2019-2021 period. In this action, EPA is finalizing our approval of the NO X RACT waiver only for the 2008 ozone standard because, as per the discussion above regarding CAA section 182(f)(1)(A), the area is attaining the 2008 ozone NAAQS, as demonstrated by three consecutive years of clean monitoring data, and EPA's modeling indicates that the Illinois portion of the Chicago area will continue to attain the 2008 ozone NAAQS in the future. In this regard, further NO X reductions will not improve the area's ability to attain the 2008 ozone standard. In contrast, EPA's ozone transport modeling indicates that, barring further emissions reductions, this area will continue to have difficulty attaining or maintaining the 2015 ozone NAAQS in 2024 (the Moderate Area attainment date for the 2015 ozone NAAQS) and beyond. A CAA section 182(f) NO X exemption granted for the 2008 standard does not relieve the area from any CAA section 182(f) NO X obligations under the 2015 ozone NAAQS (see 40 CFR 51.1313(c)). If finalized, EPA's determination that the Chicago area failed to attain the 2015 ozone NAAQS by the attainment date and accompanying reclassification to Moderate would impose the CAA's NO X RACT requirements for the 2015 ozone standard.

EPA finds that the Illinois portion of the Chicago area is attaining the 2008 ozone NAAQS and is acting in accordance with a January 25, 2022, request from Illinois to redesignate the Illinois portion of the Chicago area to attainment for the 2008 ozone NAAQS because the request meets the statutory requirements for redesignation under the CAA. EPA is approving, as a revision to the Illinois SIP, the State's plan for maintaining the 2008 ozone NAAQS through 2035 in the Illinois portion of the Chicago area.

EPA finds adequate and is approving the 2035 VOC and NO X motor vehicle emission budgets for use in transportation conformity determinations in the Illinois portion of the Chicago area. Specifically, EPA is finding adequate and approving the budgets for 2035 as proposed ( i.e., the last year of the maintenance plan) of 65 tons/day of VOCs and 110 tons/day of NO X ).

Pursuant to section 110 and part D of the CAA, EPA is also approving the VOC RACT, Enhanced I/M, CFVP, and the EMP SIP revisions submitted by Illinois, because they satisfy serious SIP requirements of the CAA for the Illinois portion of the Chicago area. Finally, EPA is approving a CAA section 182(f) waiver from NO X RACT requirements for the Illinois portion of the Chicago area under the 2008 ozone NAAQS.

In accordance with 5 U.S.C. 553(d) of the Administrative Procedure Act (APA), EPA finds there is good cause for this action to become effective immediately upon publication. The immediate effective date for this action is authorized under 5 U.S.C. 553(d)(1).

Section 553(d)(1) of the APA provides that final rules shall not become effective until 30 days after publication in the Federal Register “except . . . a substantive rule which grants or recognizes an exemption or relieves a restriction.” The purpose of this provision is to “give affected parties a reasonable time to adjust their behavior before the final rule takes effect.” Omnipoint Corp. v. Fed. Commc'n Comm'n, 78 F.3d 620, 630 (D.C. Cir. 1996); see also United States v. Gavrilovic, 551 F.2d 1099, 1104 (8th Cir. 1977) (quoting legislative history). However, when the agency grants or recognizes an exemption or relieves a restriction, affected parties do not need a reasonable time to adjust because the effect is not adverse. EPA has determined that this rule relieves a restriction because this rule relieves sources in the area of Nonattainment New Source Review (NNSR) permitting requirements; instead, upon the effective date of this action, sources will be subject to less restrictive Prevention of Significant Deterioration (PSD) permitting requirements. For this reason, EPA finds good cause under 5 U.S.C. 553(d)(1) for this action to become effective on the date of publication of this action.

Under the CAA, redesignation of an area to attainment and the accompanying approval of a maintenance plan under section 107(d)(3)(E) are actions that affect the status of a geographical area and do not impose any additional regulatory requirements on sources beyond those imposed by state law. A redesignation to attainment does not in and of itself create any new requirements, but rather results in the applicability of requirements contained in the CAA for areas that have been redesignated to attainment. Moreover, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For these reasons, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

This action is subject to the Congressional Review Act, 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).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 19, 2022. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

For the reasons stated in the preamble, E 40 CFR parts 52 and 81 are amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2021-0582 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before July 19, 2022. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2021-0582, by one of the following methods:

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

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

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

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

In the Federal Register of September 22, 2021 (86 FR 52624) (FRL8792-03), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11268) by SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192 on behalf of Albaugh, LLC. The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of cocamidopropylamine oxide when used as an inert ingredient (surfactant) at a concentration not to exceed 6% by weight in glyphosate formulations. That document referenced a summary of the petition prepared by SciReg, Inc on behalf of Albaugh, LLC, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

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

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

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

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

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

Available acute toxicity studies on cocamidopropylamine oxide show low oral, dermal, and inhalation toxicity. Cocamidopropylamine oxide was determined to be a severe eye irritant and moderate dermal irritant. Dermal sensitization studies showed cocamidopropylamine oxide was a non-sensitizer to a mild sensitizer. No mutagenic effects were noted in mutagenicity studies with cocamidopropylamine oxide. In a 28-day repeat-dose oral toxicity study in rats, hematological changes , statistically significant increase in spleen weight, and treatment-related changes in liver, spleen, kidneys, urinary bladder, and stomach were observed at the 150 mg/kg/day dose level. No adverse effects of treatment were seen in reproduction/developmental toxicity study at the highest dose tested (100 mg/kg/day). Therefore, the NOAEL for the 28-day repeat-dose oral toxicity study is 15 mg/kg/day and the parental, reproductive, and developmental NOAELs are 100 mg/kg/day.

There was no evidence of carcinogenicity or neuropathological changes or effects reported in any of the studies. The agency does not believe cocamidopropylamine oxide will be carcinogenic or neurotoxic.

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

The toxicity endpoint selected for use in risk assessment is taken from the 28-day repeat-dose toxicity study of cocamidopropylamine oxide in which a NOAEL was established at 15 mg/kg/day based on hematological changes, a statistically significant increase in spleen weight, and treatment-related changes in liver, spleen, kidneys, urinary bladder, and stomach seen at 150 mg/kg/day. The uncertainty factors include 10X for interspecies extrapolation, 10X for intraspecies variation, and a 1X for the FQPA Safety Factor, bringing the combined uncertainty factor to 100. The resultant chronic Population Adjusted Dose (cPAD) is 0.15 mg/kg/day.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to cocamidopropylamine oxide, EPA considered exposure under the proposed exemption from the requirement of a tolerance. Dietary exposure to cocamidopropylamine oxide may occur from eating foods treated with pesticide formulations containing this inert ingredient and drinking water containing runoff from soils containing the treated crops. Because no acute endpoint of concern was identified, a quantitative acute dietary exposure assessment is unnecessary. In conducting the chronic dietary exposure assessment using the Dietary Exposure Evaluation Model (DEEM)—FCIDTM, Version 3.16, EPA used food consumption information from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. Dietary exposure is estimated using the Agency's Dietary Exposure Estimate Model (DEEM). The Inert Dietary Exposure Evaluation Model (I-DEEM) is a highly conservative model with the assumption that the residue level of the inert ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this assumption is that there would be similar rates of degradation between the active and inert ingredient (if any) and that the concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient. The model assumes 100 percent crop treated (PCT) for all crops and that every food eaten by a person each day has tolerance-level residues. In the case of cocamidopropylamine oxide a 6% by weight limitation in glyphosate formulations was incorporated into the model. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

2. Dietary exposure from drinking water. For the purpose of the screening-level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for cocamidopropylamine oxide, a conservative drinking water concentration value of 100 ppb based on screening-level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

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

Cocamidopropylamine oxide may be used as an inert ingredient in pesticide products that are registered for specific uses that may result in residential exposure, such as pesticides used in and around the home, and in non-pesticide products such as personal care products and cosmetics. In a conservative effort to assess residential exposure, EPA has conducted a screening-level assessment using high-end residential exposure scenarios, such as pesticides used on lawns/turf and as antimicrobial cleaning products. Cocoamidopropylamine oxide is also used in some cosmetics, however the primary cosmetic use of cocoamidopropylamine oxide is in rinse-off hair care products in which dermal absorption would be unlikely given its highly polarized molecular structure and short contact time. As a result, such uses would result in negligible residential exposure to cocamidopropylamine oxide.

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

EPA has not found cocamidopropylamine oxide to share a common mechanism of toxicity with any other substances, and cocamidopropylamine oxide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that cocamidopropylamine oxide does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

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

2. Prenatal and postnatal sensitivity. The Agency has concluded that there is reliable data to determine that infants and children will be safe if the FQPA SF of 10X is reduced to 1X for the assessment of all exposure for the following reasons. The toxicity database for cocamidopropylamine oxide contains subchronic, developmental, reproduction, and mutagenicity studies. There is no indication of immunotoxicity or neurotoxicity in the available studies; therefore, there is no need to require an immunotoxicity or neurotoxicity study. No fetal susceptibility is observed in developmental/reproductive toxicity studies in the rat. Neither maternal, offspring nor reproduction toxicity is observed in any of the studies. Therefore, based on the adequacy of the toxicity database, the conservative nature of the exposure assessment and the lack of concern for prenatal and postnatal sensitivity, the Agency has concluded that there is reliable data to determine that infants and children will be safe if the FQPA SF of 10x is reduced to 1x all exposure scenarios.

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

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

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to cocamidopropylamine oxide from food and water will utilize 82% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure.

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

Cocamidopropylamine oxide may be used as an inert ingredient in pesticide products that are registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to cocamidopropylamine oxide.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 195 for both adult males and females and 105 for children. Because EPA's level of concern for cocamidopropylamine oxide is a MOE of 100 or below, these MOEs are not of concern.

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

Cocamidopropylamine oxide may be used as an inert ingredient in pesticide products that are registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to cocamidopropylamine oxide.

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in aggregate MOEs of 195 for adult males and females and 105 for children. Because EPA's level of concern for cocamidopropylamine oxide is a MOE of 100 or below, these MOEs are not of concern.

5. Aggregate cancer risk for U.S. population. Based on the lack of structural alerts in the DEREK expert-based knowledge analysis regarding carcinogenicity, cocamidopropylamine oxide is not expected to pose a cancer risk to humans.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to cocamidopropylamine oxide residues.

An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of cocamidopropylamine oxide ADAOs in or on any food commodities. EPA is establishing limitations on the amount of cocamidopropylamine oxide that may be used in glyphosate formulations. These limitations will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. 136 et seq. EPA will not register any glyphosate formulation for food use that contains cocoamidopropylamine oxide at concentations that exceed 6% by weight of the glyphosate formulation.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180. 910 for cocamidopropylamine oxide (CAS Reg. No. 68155-09-9) when used as inert ingredient (surfactant) in glyphosate formulations at a concentration not to exceed 6% by weight in the formulation.

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

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

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

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

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

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

This is a summary of the Commission's document, Public Notice, in WT Docket No. 21-333; DA 22-300, released on March 21, 2022. The complete text of this document is available on the Commission's website at https://www.fcc.gov/document/wtb-announces-appeal-procedures-c-band-clearinghouse-decisions.

This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

The Commission will not send a copy of this document to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A), because the adopted action is an action of particular applicability.

With this document, the Wireless Telecommunications Bureau (WTB or Bureau) establishes procedures for the filing and processing of challenges to decisions made by the 3.7-4.2 GHz (C-band) Relocation Payment Clearinghouse (Clearinghouse).

In the 3.7 GHz Report and Order (85 FR 22804, April 23, 2020), the Commission found that selecting a single, independent clearinghouse to oversee cost-related aspects of the C-band transition in a fair and transparent manner, subject to Commission oversight, would best serve the public interest. Among its duties set forth by the Commission, the Clearinghouse is responsible for making initial determinations about the reasonableness of transition-related cost reimbursement claims. The Clearinghouse also apportions costs among 3.7 GHz Service Licensees and distributes payments to claimants that incur compensable costs. The 3.7 GHz Report and Order also specified that the Clearinghouse will serve “in an administrative role and in a function similar to a special master in a judicial proceeding” and “may mediate any disputes regarding cost estimates or payments that may arise in the course of band reconfiguration; or refer the disputant parties to alternative dispute resolution fora.” Any unresolved issues relating to Clearinghouse decisions may be appealed to the Bureau.

This document sets forth the procedures by which eligible parties may appeal Clearinghouse decisions to the Bureau. As an initial matter, we clarify that before the Bureau will consider any appeal, the relevant party or parties, whether an eligible incumbent claimant or eligible 3.7 GHz Service Licensee, must first timely file a notice of objection with the Clearinghouse as required by the Commission's rules and pursuant to the process established in the Clearinghouse Dispute Resolution Plan (RPC DRP). Interlocutory appeals, before a timely notice of objection is filed with the Clearinghouse, will not be considered by the Bureau.

The RPC DRP identifies different scenarios and timeframes within which eligible parties must file a notice of objection. Specifically, the RPC DRP requires eligible incumbent claimants or eligible 3.7 GHz Service Licensees to file a notice of objection with the Clearinghouse within twenty (20) days of invoice issuance following Clearinghouse review of lump sum or reimbursement claims. Where the eligible incumbent claimant first files a notice of objection to the Clearinghouse's decision on its lump sum or reimbursement claim within the applicable twenty (20) day timeline, and an eligible 3.7 GHz Service Licensee also wishes to be a party to that objection, that eligible 3.7 GHz Licensee must itself file an objection within thirty (30) days of invoice issuance. We clarify that the same approach and timeline will apply in cases where the first notice of objection to a lump sum or reimbursement claim is filed by the eligible 3.7 GHz Service Licensee within the applicable twenty (20) day timeline and the eligible incumbent claimant wishes to be a party to that appeal. In such cases, that eligible incumbent claimant must itself file an objection with the Clearinghouse within thirty (30) days of invoice issuance. Where one or more eligible 3.7 GHz Service Licensees wish to dispute any type of payment or cost sharing decision by the Clearinghouse other than a lump sum or reimbursement claim, they must file an objection within twenty (20) days of statement or invoice issuance. We further clarify that any other eligible 3.7 GHz Service Licensee wishing to be a party to an objection of this type first filed by a different eligible 3.7 GHz Service Licensee must itself file an objection with the Clearinghouse within thirty (30) days of statement or invoice issuance.

There are two possible paths pursuant to which an appeal of a Clearinghouse decision can be made to the Bureau, depending on which party or parties submit a timely notice of objection with the Clearinghouse. The first path is a single-party dispute where one eligible party (whether an incumbent claimant or 3.7 GHz Service Licensee) files a timely notice of objection with the Clearinghouse and no other eligible party elects to join by filing its own timely notice of objection with the Clearinghouse. The second path is a multi-party dispute where more than one eligible party files a timely notice of objection regarding the same determination with the Clearinghouse, and the mediation and arbitration provisions in § 27.1421(b) of the Commission's rules have already been satisfied (47 CFR 1421(b)). For example, a multi-party dispute could involve both an eligible incumbent claimant or one or more eligible 3.7 GHz Service Licensees in the case of lump sum or reimbursement claim review, or multiple eligible 3.7 GHz Service Licensees where the apportionment of relocation costs is at issue. Below, we detail the specific procedures applicable to each path. In all cases, the requirements (including deadlines) of the 3.7 GHz Report and Order and this document, and any other requirements established by the Commission or WTB, must be satisfied before the Bureau will consider an appeal.

Single-Party Disputes: If an eligible incumbent claimant or eligible 3.7 GHz Service Licensee submits a timely objection to the Clearinghouse that is not joined by any other eligible party, the following process applies:

1. The appealing party must directly submit a written appeal to the Bureau seeking review of the Clearinghouse's decision no later than thirty (30) days from the date any other eligible party fails to file a timely notice of objection with the Clearinghouse. While the Clearinghouse should provide notice to the appealing party that no other eligible party has joined its dispute within three (3) business days of such event, we clarify that the appealing party must directly file a written appeal to the Bureau by the requisite thirty (30) day deadline in order for its appeal to be considered by the Bureau.

2. The burden of proof lies on the appealing party to demonstrate in its appeal that the Clearinghouse decision was incorrect. Appealing parties bear responsibility for their costs associated with an appeal, none of which are reimbursable transition expenses.

3. The Bureau will issue regular public notices setting pleading cycles for any single-party appeals received in a given week and assigning file numbers to each appeal.

4. The Clearinghouse will automatically be joined as the opposing party to any such appeal and have ten (10) days from the date of any such public notice to respond, including the submission of any decisional paperwork or supporting materials.

5. The appealing party will have five (5) days thereafter for any reply. Filings by third parties are not permitted.

6. All pleadings and documentation relating to an appeal shall be submitted electronically, using the Commission's Electronic Comment Filing System (ECFS) in WT Docket No. 21-333, with a copy thereof served electronically on the Clearinghouse as opposing party. These pleadings and documents must also comply with § 1.49 of the Commission's rules (47 CFR 1.49).

7. The first page of any pleading or other document filed by a party shall be captioned with the name and address of the parties and the file number assigned by the Bureau.

8. Any party may request confidential treatment of any document, or portion thereof, pursuant to § 0.459 of the Commission's rules (47 CFR 0.459).

9. The Bureau may, at its discretion, designate the matter for an evidentiary hearing before an Administrative Law Judge, making the Enforcement Bureau a party.

Multi-Party Disputes: If an eligible incumbent claimant or eligible 3.7 GHz Service Licensee submits a timely objection to the Clearinghouse that is joined by at least one other eligible party, the following process applies:

1. Following the filing of timely notices of objection by multiple eligible parties with the Clearinghouse, such parties must first satisfy the mediation and arbitration provisions in § 27.1421(b) of the Commission's rules (47 CFR 27.1421(b)).

2. Should any issues still remain unresolved and the parties have not opted for arbitration pursuant to Section 9 of the RPC DRP, the Clearinghouse may refer the matter to the Bureau within ten (10) days of the recommended decision or advice of the Clearinghouse (qua mediator) or other mediator. Should all parties elect to seek non-binding expedited arbitration, the same ten (10) day timeframe will be applicable to referral of the matter to the Bureau for review following issuance of a recommended decision or advice from the Clearinghouse (qua arbitrator) or other arbitrator.

3. The Clearinghouse shall forward the entire record on any disputed issues, including such dispositions thereof that the Clearinghouse has considered. The Bureau will rely on the factual record before it as provided by the Clearinghouse.

4. The burden of proof is on each party to demonstrate that their view is correct. All eligible parties that filed timely notices of objection with the Clearinghouse and participated in the underlying mediation or arbitration will automatically be parties to the appeal unless they opt out by providing written notice to the Bureau as set forth below. Appealing parties bear responsibility for their costs associated with an appeal, none of which are reimbursable transition expenses.

5. The Bureau will issue a public notice upon receipt of the record from the Clearinghouse and assign a file number to the appeal.

6. Each party has ten (10) days from the date of such public notice to either submit statements of position or opt out of the appeal by providing written notice to the Bureau. Statements shall comply with § 1.49 of the Commission's rules (47 CFR 1.49). Statements must be strictly limited to issues raised in the course of mediation and/or arbitration and facts contained in the record. In their statements, parties may not introduce facts not contained in the record or introduce arguments on issues that were not presented to the mediator and/or arbitrator for consideration. Any material not conforming to these restrictions will be stricken. Reply filings and filings by third parties are not permitted. The Clearinghouse and any party to the appeal may file other documents or pleadings only if specifically requested by the Commission.

7. Parties' statements, any record documents, and opt out notices shall be submitted electronically, using the Commission's ECFS in WT Docket No. 21-333, with a copy thereof served electronically on any other party to the appeal and the Clearinghouse. These documents must also comply with § 1.49 of the Commission's rules (47 CFR 1.49).

8. The first page of any statement or other document filed by a party shall be captioned with the name and address of the parties and the file number assigned by WTB.

9. The Clearinghouse and any party to the appeal may request confidential treatment of any document, or portion thereof, pursuant to § 0.459 of the Commission's rules (27 CFR 0.459).

10. The Bureau may, at its discretion, designate the matter for an evidentiary hearing before an Administrative Law Judge, making the Enforcement Bureau a party.

Following a Bureau decision in either a single-party or multi-party dispute, any party to a specific matter wishing to appeal that decision may do so by filing with the Commission, within ten (10) days of the effective date of the Bureau decision, a petition for de novo review, whereupon the Commission will set the matter for an evidentiary hearing before an Administrative Law Judge. Parties seeking de novo review of a decision by the Bureau are advised that, in the course of the evidentiary hearing, the Commission may require complete documentation relevant to any disputed matters, and, where necessary, and at the presiding judge's discretion, require expert engineering, economic, or other reports, or testimony, and that the cost of producing such documentation is not a reimbursable transition expense. Parties may therefore wish to consider possibly less burdensome and expensive means of resolving their disputes, such as alternative dispute resolution.

A party to any appeal, whether single-party or multi-party, must certify in each submission that it attests to the truthfulness of the information it is providing and is making the submission in good faith. We remind parties of their obligations under § 1.17 of the Commission's rules (47 CFR 1.17), and note that violators will be subject to potential enforcement action. The Bureau will determine a submission has been made in bad faith if, for example, the submitting party makes a statement that is false and if it finds the party did not use due diligence in providing information that is correct and not misleading to the Commission, including taking appropriate affirmative steps to determine the truthfulness of what is being submitted.

Restricted Proceeding. This docket and each appeal is a “restricted” proceeding under § 1.1208 (47 CFR 1.1208) of the Commission's rules, and thus ex parte presentations to or from Commission decision-making personnel, including the Chief and staff of the Wireless Telecommunications Bureau, are prohibited, except as otherwise provided in the Commission's rules.

Atlantic HMS fisheries, including BFT fisheries, are managed under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq. ) and the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq. ). The 2006 Consolidated Atlantic HMS Fishery Management Plan (FMP) and its amendments are implemented by regulations at 50 CFR part 635. Section 635.27 divides the U.S. BFT quota recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT) and as implemented by the United States among the various domestic fishing categories, per the allocations established in the 2006 Consolidated HMS FMP and its amendments. NMFS is required under the Magnuson-Stevens Act to provide U.S. fishing vessels with a reasonable opportunity to harvest quotas under relevant international fishery agreements such as the ICCAT Convention, which is implemented domestically pursuant to ATCA.

Under § 635.28(a)(1), NMFS files a closure notice with the Office of the Federal Register for publication when a BFT quota (or subquota) is reached or is projected to be reached. Retaining, possessing, or landing BFT under that quota category is prohibited on and after the effective date and time of a closure notice for that category, for the remainder of the fishing year, until the opening of the subsequent quota period or until such date as specified.

The 2022 BFT fishing year, which is managed on a calendar-year basis and subject to an annual calendar-year quota, began January 1, 2022. The Angling category season opened January 1, 2022, and continues through December 31, 2022. The Angling category baseline quota is 232.4 metric tons (mt), of which 5.3 mt is allocated for the harvest of large medium and giant (trophy) BFT by vessels fishing under the Angling category quota, with 1.8 mt allocated for each of the following areas: North of 39°18′ N lat. (off Great Egg Inlet, NJ); south of 39°18′ N lat. and outside the Gulf of Mexico (the “southern area”); and in the Gulf of Mexico. Trophy BFT measure 73 inches (185 cm) curved fork length or greater.

Based on landings data from the NMFS Automated Catch Reporting System, as well as average catch rates and anticipated fishing conditions, NMFS projects the Angling category Gulf of Mexico incidental trophy BFT subquota of 1.8 mt has been reached and exceeded. Therefore, retaining, possessing, or landing large medium or giant ( i.e., measuring 73 inches (185 cm) curved fork length or greater) BFT in the Gulf of Mexico by persons aboard Angling and HMS Charter/Headboat permitted vessels must cease at 11:30 p.m. local time on May 17, 2022. This closure will remain effective through December 31, 2022. This action applies to HMS Angling and HMS Charter/Headboat permitted vessels, and is taken consistent with the regulations at § 635.28(a)(1). This action is intended to prevent overharvest of the Angling category Gulf of Mexico incidental trophy BFT subquota.

If needed, subsequent Angling category adjustments will be published in the Federal Register . Information regarding the Angling category fishery for Atlantic tunas, including daily retention limits for BFT measuring 27 inches (68.5 cm) to less than 73 inches (185 cm) and any further Angling category adjustments, is available at hmspermits.noaa.gov or by calling (978) 281-9260. HMS Angling and HMS Charter/Headboat permit holders may catch and release (or tag and release) BFT of all sizes, subject to the requirements of the catch-and-release and tag-and-release programs at § 635.26. Anglers are also reminded that all BFT that are released must be handled in a manner that will maximize survival, and without removing the fish from the water, consistent with requirements at § 635.21(a)(1). For additional information on safe handling, see the “Careful Catch and Release” brochure available at https://www.fisheries.noaa.gov/resource/outreach-and-education/careful-catch-and-release-brochure/.

HMS Angling and HMS Charter/Headboat permitted vessel owners are required to report the catch of all BFT retained or discarded dead, within 24 hours of the landing(s) or end of each trip, by accessing hmspermits.noaa.gov, using the HMS Catch Reporting app, or calling (888) 872-8862 (Monday through Friday from 8 a.m. until 4:30 p.m.).

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act and regulations at 50 CFR part 635 and is exempt from review under Executive Order 12866.

The Assistant Administrator for NMFS finds that it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons:

The regulations implementing the 2006 Consolidated HMS FMP and its amendments provide for inseason adjustments and fishery closures to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. This fishery is currently underway and delaying this action could result in excessive trophy BFT landings that may result in future potential quota reductions for the Angling category, depending on the magnitude of a potential Angling category overharvest. NMFS must close the Gulf of Mexico incidental trophy BFT fishery before additional landings of these sizes of BFT occur. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For all of the above reasons, there is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.