On November 2, 2015, the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act), which further amended the Federal Civil Penalties Inflation Adjustment Act of 1990, was signed into law to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. The 2015 Act requires agencies to adjust for inflation annually.

This rule amends 7 CFR part 3 to update the amount of civil monetary penalties that may be levied by U.S. Department of Agriculture (USDA) agencies to reflect inflationary adjustments for 2025 in accordance with the 2015 Act. As required by the 2015 Act, the annual adjustment was made for inflation based on the Consumer Price Index for the month of October 2024 and rounded to the nearest dollar after an initial adjustment. The civil monetary penalties are listed according to the applicable administering agency.

This rule is required by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, with no issue of policy discretion. Accordingly, pursuant to the administrative procedure provisions in 5 U.S.C. 553, we find upon good cause that prior notice and other public procedure with respect to this action are not necessary. We also find good cause for making this action effective less than 30 days after publication in the Federal Register .

The Office of Management and Budget (OMB) has determined that this regulatory action does not meet the criteria for significant regulatory action pursuant to Executive Order 12866, Regulatory Planning and Review.

This rule contains inflation adjustments in compliance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. The great majority of individuals, organizations, and entities participating in the programs affected by this regulation do not engage in prohibited activities and practices that would result in civil monetary penalties being incurred. Accordingly, we believe that any aggregate economic impact of this revised regulation will be minimal, affecting only the limited number of program participants that may engage in prohibited behavior in violation of the statutes. Moreover, USDA has determined that this revised regulation is expressly exempt from the requirements of Executive Order 14192, Unleashing Prosperity Through Deregulation, because it pertains to agency organization and management.

The provisions of the Regulatory Flexibility Act relating to an initial and final regulatory flexibility analysis (5 U.S.C. 603, 604) are not applicable to this final rule because USDA was not required to publish notice of proposed rulemaking under 5 U.S.C. 553 or any other law. Accordingly, a regulatory flexibility analysis is not required.

This final rule imposes no new reporting or recordkeeping requirements necessitating clearance by OMB.

Accordingly, we are amending 7 CFR part 3, subpart I, as follows:

Part I of subtitle B of title III of the Agricultural Adjustment Act of 1938 (7 U.S.C. 1311 et seq. ) authorized the establishment of a national marketing quota program for tobacco to facilitate the orderly marketing of tobacco, thus avoiding abnormally excessive supplies being produced and dumped indiscriminately on the Nation-wide market. However, the Fair and Equitable Tobacco Reform Act of 2004 (sec. 611(b), Pub. L. 108-357, 118 Stat. 1522; Oct. 22, 2004) eliminated the price support and quota system for tobacco produced in the United States as well as mandatory grading of types of tobacco eligible for price support.

AMS's regulations governing tobacco marketed under the quota program are contained in 7 CFR 29. Upon reviewing these regulations in light of changes to the law and in alignment with Executive Order 14192, AMS has determined that regulations in 7 CFR part 29 pertaining to the obsolete market quota program should be removed and, where appropriate, amended.

AMS is removing the statutory authorities listed under this subpart B heading since these authorities are redundant—already cited under the heading for part 29. Paragraph (2) under paragraph (a) of § 29.47a is amended to remove provisions directly related to market quota provisions. Likewise, paragraph (6) under paragraph (a) of § 29.47a are removed as they directly pertain to market quota provisions.

AMS is removing redundant and obsolete statutory authorities listed under subpart C heading.

The language in the heading of subpart F is amended to remove references to obsolete market quota program, and the obsolete statutory authorities listed under this subpart heading are being removed. Multiple sections throughout subpart F, including §§ 29.9207, 29.9221, 29.9240, and 29.9261-9262, are being removed as they pertain to the obsolete market quota program. Lastly, §§ 29.9232-9234, and 29.9236, are amended by removing the word “nonquota,” and § 29.9241 is amended by removing the phrase “with no other quota, nonquota.”

Given that AMS has not provided services related to the tobacco quota program in twenty years, there are no known costs or benefits associated with removing AMS's regulations governing tobacco marketed under the quota program. Mandatory inspection and grading of tobacco subject to marketing quota were user-fee based services, which are services paid for by the industry through fees. Fee rates for tobacco inspection and grading services were set such that all costs associated with these services were covered by revenues generated from providing these services. To the extent there is any uncertainty about the costs and benefits of these regulations, it is the policy of USDA to err on the side of deregulation and focus resources on fairly and rationally enforcing a discrete and manageable number of regulations.

Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq. ) authorizes agencies to dispense with prior notice and comment for rules when the agency for “good cause” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without first publishing a proposed rule. Removing regulations pertaining to tobacco market quotas and making conforming amendments will provide transparency and may reduce confusion for tobacco producers and other stakeholders. Further, AMS views this action as noncontroversial and anticipates no adverse public comment. This rule will become effective, as published in this document, July 28, 2025 without further action, unless adverse comments are received on or before June 30, 2025. Adverse comments are considered to be those comments that suggest the rule should not be adopted or suggest the rule should be changed.

If AMS receives adverse comments, we will publish a document in the Federal Register , withdrawing this rule before the effective date. AMS will then publish a proposed rule for public comment. Following the close of that comment period, the comments will be considered, and a final rule addressing the comments will be published.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), AMS certifies that this direct final rule will not, if issued, have a significant economic impact on a substantial number of small entities. AMS has not provided services related to the tobacco quota program in twenty years. The amendments made by the direct final rule will merely conform the CFR with AMS' current operating practices. This rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by OMB. There are no current information collections associated with the regulations related to the tobacco market quota program.

USDA has determined that there is no reliance interest in obsolete regulations. Moreover, regardless of the lawfulness, USDA has no interest in maintaining regulations that have expired authorizing statutes or govern non-operational programs. Maintaining regulations pertaining to the obsolete tobacco market quota program in 7 CFR part 29 are not a priority. Therefore, AMS is amending 7 CFR 29 to remove, and where appropriate, references and provisions pertaining to mandatory inspection and grading required by the obsolete market quota program.

For the reasons set forth in the preamble, AMS amends 7 CFR part 29 as follows:

Background

The President's Executive Order 14219 of February 19, 2025, Ensuring Lawful Governance and Implementing the President's “Department of Government Efficiency” Deregulatory Initiative, 90 FR 10583, and subsequent implementing memorandum directed all agency heads to review regulations within their purview and rescind those that are, among other things, unlawful or unnecessary. FSA has undertaken such a review and is accordingly rescinding the following provisions from title 7 of the Code of Federal Regulations.

This document does not meet the criteria for a significant regulatory action as specified by Executive Order (E.O.) 12866. This action also has no federalism or tribal implications and will not impose substantial unreimbursed compliance costs on States, local governments, or Indian Tribal governments. Therefore, impact statements are not required under E.O. 13132 or 13175.

This rule will have no significant effect on the human environment; therefore, neither an environmental assessment nor impact statement is required.

This rule does not contain reporting or recordkeeping requirements subject to the Paperwork Reduction Act.

The regulations removed are:

The regulations at 7 CFR part 750, published at 21 FR 6289 and redesignated by 26 FR 5788, are no longer carried in the CFR. Thus, for the reasons explained in the preamble, FSA is eliminating this part to streamline title 7.

For the reasons described in the preamble, FSA is eliminating the regulations for the Tree Assistance Program (TAP) and the Supplemental Revenue Assistance Payments Program (SURE) codified at 7 CFR part 760 subpart F and subpart G, respectively.

The TAP regulations in 760 subpart F are obsolete as the operative assistance program regulations have been moved to 7 CFR part 1416 subpart E. The regulations in 760 subpart G are obsolete as the time to claim eligible losses under the SURE has passed.

For the reasons described in the preamble, FSA is eliminating the regulations codified at 7 CFR part 784 related to the 2004 Ewe Lamb Replacement and Retention Payment Program. This 2004 program, authorized by Section 32 of the Act of August 24, 1935, as amended, is no longer available as all funds have been used. The regulations at 7 CFR part 784 implementing the program are therefore obsolete and unnecessary.

For the purposes outlined in the preamble, FSA is rescinding the payment limitations codified at 7 CFR Part 795.

Part 795 formerly described the payment limitations applicable to certain FSA programs. However, the current payment limitations are set forth at 7 CFR part 1400. The regulations in part 795 are accordingly obsolete and unnecessary. Since part 795 is the only part remaining in subchapter E, FSA is also removing and reserving that subchapter.

For the reasons stated in the preamble, and under the authority of 5 U.S.C. 553 and as set forth below, FSA amends 7 CFR chapter VII as follows:

Background

Title I of the Disaster Relief Supplemental Appropriations Act, 2025 (Division B of the American Relief Act, 2025; Pub. L. 118-158; referred to as “the Act” in this document) provides $30,780,000,000, to remain available until expended, for necessary expenses related to losses of revenue, quality or production of crops (including milk, on-farm stored commodities, crops prevented from planting, and harvested adulterated wine grapes), trees, bushes, and vines, as a consequence of droughts, wildfires, hurricanes, floods, derechos, excessive heat, tornadoes, winter storms, freeze, including a polar vortex, smoke exposure, and excessive moisture occurring in calendar years 2023 and 2024. From that amount, the Act directs the Secretary of Agriculture to use up to $2 billion to provide assistance to livestock producers, as determined by the Secretary, for losses incurred during calendar years 2023 and 2024 due to drought, wildfires, or floods.

This rule specifies how FSA will implement ELRP 2023 and 2024, which will use approximately $1 billion of the $2 billion provided by the Act to provide financial assistance to eligible livestock producers for losses incurred during 2023 and 2024. Payments will be made to offset foregone profits resulting from the loss of quality and quantity of forage due to qualifying drought and qualifying wildfires, using a streamlined process as described below. Livestock producer losses due to flooding which will be addressed in a later rule. If funding remains available after issuing assistance for flooding, FSA may make additional payments to ELRP 2023 and 2024 participants.

According to USDA National Agricultural Statistics Service (NASS) data, average corn prices have steadily decreased and livestock prices have increased since September 2022, meaning that margins have substantially increased. 1 This trend would normally cause producers to maintain or expand their livestock operations. NASS data, however, indicate that livestock inventories, particularly beef cattle, have steadily decreased since 2018  2 despite cattle prices increasing over 60 percent during that period. 3 With limited grazing capacity caused by drought and wildfires, livestock producers were unable to expand and take advantage of increased margins. 4

Drought and wildfires in the 2023 and 2024 calendar years, particularly in the western United States, have had a significantly negative impact on:

• Forage availability and quality—decreased grazing options equated to reduced carrying capacities and increased expenses for supplemental feed;  5

• Livestock inventories and retention—the inability to lease or purchase additional grazing land made it more difficult for farmers and ranchers to sustain operations, and producers were forced to cull animals rather than expand their operations;  6 and

• Livestock revenue and production losses—poor forage quality and quantity contributed to a reduction in livestock production, typically through a decline in livestock condition and body weight, which results in lower livestock weaning weights and lower conception rates in breeding livestock. 7

As explained in the ELRP 2023 and 2024 Cost Benefit Analysis (CBA), persistent and severe drought and wildfire events have significantly impacted forage availability and herd sustainability, underscoring the necessity of federal intervention to stabilize the livestock industry and mitigate economic losses.

ELRP 2023 and 2024 is designed to compensate livestock producers for losses incurred during 2023 and 2024 by making payments in order to offset foregone profits due to qualifying drought and qualifying wildfires. 8 Note that foregone profits represent the difference between profits realized by a producer and the profits that could have been achieved by the producer in the absence of certain adverse circumstances. During 2022, feed and grazing costs were extreme, while livestock prices were relatively normal. As a result, livestock production returns were reduced, which became the basis for the ELRP 2022 payment. Since that time, with systemic drought occurring year after year, livestock producers have been forced to reduce the number of cattle grazed per acre as grazing capacity has been woefully short. ELRP 2023 and 2024 compensates for livestock production that would have occurred had there not been extensive drought.

As an example, a livestock producer with 500 acres of pastureland could normally graze 100 head of cattle, but with continuous annual drought conditions during 2023 and 2024, producers have been forced to reduce their stocking rates or livestock inventories as the availability of grazing and supplemental feed is limited or may be cost prohibitive. As explained above, despite increasing livestock prices and profit margins, many producers were unable to sustain their operations, let alone expand. In addition, drought and wildfire impacted the quality and quantity of forage, which negatively impacted livestock production and profits due to decreased livestock body condition, weights, and breeding conception rates. 9 Without these adverse conditions, producers could have realized significantly higher earnings.

Illustrating the decline in livestock capacity nationally due to drought and wildfires, NASS data on the total inventory of cattle, including calves, was 86.7 million head on January 1, 2025, compared to the pre-pandemic and lower-drought-impact inventory of 94.7 million head on January 1, 2019  10 —a drop of 8.45 percent. 11 In order to estimate losses incurred during 2023 and 2024 as measured by foregone profits, USDA used the average fair market value for non-adult beef cattle weighing over 800 lbs., representing 1 animal unit (AU), which is established for the Livestock Indemnity Program (LIP) and is consistent with Animal Plant Health and Inspection Service programs. The values are $1,659.50 for 2023 and $2,187.00 for 2024. 12

For 2023, the estimated foregone profits due to drought and wildfire are equal to: (2018 inventory of 94.7 million—2023 inventory of 87.2 million) × $1,659.50 per AU × 10% profit margin  13 = approximately $1.25 billion or $165.95 per AU.

For 2024, the estimated foregone profits due to drought and wildfire are equal to: (2018 inventory of 94.7 million—2024 inventory of 86.7 million) × $2,187.00 per AU × 10% profit margin = approximately $1.75 billion dollars or $218.70 per AU.

These calculations result in an average annual foregone profit value of $192.32 per AU ($165.90 in 2023 + $218.70 in 2024, divided by 2), or total foregone profit for 2023 and 2024 of about $3.0 billion to the nation's beef cattle industry or $384.65 per AU.

Similar to previous programs, ELRP 2023 and 2024 will use 2023 and 2024 LFP data already submitted by an eligible producer as a proxy for the payment calculation, representing a percentage of the payment made through LFP for losses incurred during 2023 and 2024 as a direct result of a qualifying drought or wildfire that impacted a producer's foregone profits. This eliminates the requirement for producers to resubmit information to FSA. 14 This approach reduces application burdens for livestock producers by eliminating the need to submit an additional application form, and it streamlines administrative processes for FSA county offices by eliminating the need to process an additional application and enter data into software when the necessary data is already on file with FSA.

Although LFP payments do not compensate livestock producers for their foregone profits, LFP payments directly reflect the severity of the drought or wildfire experienced by an LFP participant. 15 LFP payments are made to eligible owners and contract growers of covered livestock who suffered livestock grazing losses due to qualifying drought or fire, not to exceed five months of assistance during the normal grazing period for drought, based on the documented livestock inventory eligible for LFP. The gross LFP calculated payment represents a 60 percent reimbursement of monthly feed costs for a maximum of 5 months for drought, or 50 percent of feed costs for the number of days of prohibited grazing due to fire, not to exceed 180 days. 16 In 2023, the LFP monthly payment rate per AU was $58.12, while in 2024, it decreased to $52.56. Producers receive drought payments equal to 60 percent of their estimated feed costs, amounting to $34.87 per AU in 2023 and $31.54 per AU in 2024 (see Column A in Table 1 below). 17

FSA has determined the calculated national average foregone profits for livestock producers in 2023 and 2024 were $165.95 and $218.70 per AU, respectively (see calculation above). ELRP 2023 and 2024 uses the average of the calculated 2023 and 2024 foregone profits, $192.32 per AU (see Column E in Table 1 below), as the identified loss to producers that is compensated by ELRP 2023 and 2024. This approach streamlines the payment calculation and provides a commensurate level of assistance for similar losses. Total payments under ELRP 2023 and 2024, including any subsequent payments if funding remains available, will not exceed 60 percent of the calculated foregone profits per AU for the applicable calendar year.

FSA has determined that the initial ELRP 2023 and 2024 payment factor is 35 percent of the LFP gross calculated payment to stay within the funding amount that will be used for losses due to drought and wildfire and streamline delivery of assistance. Table 1 illustrates the percentage of calculated foregone profits per year per AU that would be covered by the corresponding ELRP 2023 and 2024 payment—32 percent for 2023 and 29 percent for 2024 (see Column F in Table 1). LFP compensates for grazing losses suffered in a calendar year using the drought severity as published by the U.S. Drought Monitor which determines the number of months of assistance provided by LFP.

The calculations in Table 1 are based on an LFP payment for D4 (Exceptional Drought) intensity for at least 4 weeks, which results in the maximum LFP payment equal to a five-month payment. The ELRP 2023 and 2024 calculated benefit per AU (Table 1, Column D) and the corresponding percentage of foregone profits (Table 1, Column F) would be lower if the LFP gross payment, used as a proxy, was based on less than a five-month payment for drought or a payment for wildfire.

Table 2 illustrates a situation where a producer received an LFP payment for both 2023 and 2024, representing five months of disaster assistance for each program year. In this example, the producer has 250 head of cattle eligible for 2023 ELRP and 250 head eligible for 2024 ELRP, and received the maximum LFP payment. Therefore, the producer is also eligible for the maximum ELRP benefit per head. In this example, this producer's estimated gross 2023 and 2024 ELRP payments, using an ELRP payment factor of 35 percent, are calculated to be $15,256 for 2023 losses and $13,799 for 2024 losses (Table 2 Column F), or $61.02 per AU for 2023 and $55.20 per AU for 2024 (Table 2 Column G).

Additional ELRP 2023 and 2024 payments may be issued if funding is available after losses for flooding are issued, not to exceed 60 percent of calculated foregone profits.

To be eligible for ELRP 2023 and 2024, a livestock producer must have an approved LFP application for the 2023, 2024, or both program years. 18 Eligible producers may receive payment for one or both years. The eligibility criteria applicable to LFP also apply to ELRP 2023 and 2024, excluding the LFP average adjusted gross income (AGI) limitation, consistent with other disaster programs including ELRP, ELRP 2022, the Emergency Relief Program (ERP), ERP 2022, 2017 Wildfire and Hurricane Indemnity Program (WHIP), and WHIP+.

Because ELRP 2023 and 2024 is based on a producer's gross LFP calculated payment, the resulting ELRP 2023 and 2024 payments will be based on the following data reported on an eligible livestock producer's approved CCC-853, Livestock Forage Disaster Program Application, for the 2023 or 2024 program year:

• livestock inventories/AUs,

• forage acreage,

• restricted AUs and grazing days due to fire, and

• qualifying drought and fire information.

ELRP 2023 and 2024 payments will be calculated separately for each year by multiplying the gross LFP calculated payment for the applicable program year (2023 or 2024) by the ELRP payment factor of 35 percent to determine the total gross payment for the program year, prior to any applicable payment reductions.

FSA will issue ELRP 2023 and 2024 payments as 2023 and 2024 LFP applications are processed and approved. If a producer becomes eligible for the increased payment limitation described below by filing the FSA-510 form and the accompanying certification by the deadline announced by the Deputy Administrator but after their ELRP 2023 or 2024 payment is issued, FSA will recalculate the ELRP 2023 or 2024 payment and issue the additional amount.

As required by the Act, ELRP 2023 and 2024 is subject to payment limitations consistent with 7 CFR 760.1507, as in effect on December 21, 2024. Separate payment limitations apply to each year (2023 and 2024). The payment limitation for ELRP 2023 and 2024 is determined by the person's or legal entity's average adjusted gross farm income. Specifically, a person or legal entity, other than a joint venture or general partnership, cannot receive, directly or indirectly, more than $125,000 for each year if their average adjusted gross farm income is less than 75 percent of their average adjusted gross income (AGI) for the applicable base period. If at least 75 percent of the person or legal entity's average AGI is average adjusted gross farm income and the participant provides the required certification and documentation, as discussed below, the person or legal entity, other than a joint venture or general partnership, is eligible to receive, directly or indirectly, up to $250,000 for each year.

Average adjusted gross farm income includes income derived from farming, ranching, and forestry operations, which has the same meaning for ELRP 2023 and 2024 as in other recent FSA programs such as ERP, ELRP, and ELRP 2022. If the average adjusted gross farm income derived from the items listed in the definition of “income derived from farming, ranching, and forestry operations” (7 CFR 760.2002) is at least 66.66 percent of the average adjusted gross income of the person or legal entity, then the average adjusted gross farm income may also take into consideration income or benefits derived from the sale, trade, or other disposition of equipment to conduct farm, ranch, or forestry operations, and the provision of production inputs and production services to farmers, ranchers, foresters, and farm operations. Inclusion of those items and benefits in this manner was first introduced by section 1604 of the Food Conservation and Energy Act of 2008 (Pub. L. 110-234), which amended section 1001D of the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171). This provision has been applied in other recent FSA and Commodity Credit Corporation programs that use a producer's average adjusted gross farm income for payment eligibility or payment limitation purposes.

As provided in 7 CFR 1400.105, a payment made to a legal entity will be attributed to those members who have a direct or indirect ownership interest in the legal entity unless the payment to the legal entity has been reduced by the proportionate ownership interest of the member due to that member's ineligibility. As in other FSA programs, attribution of payments made to legal entities will be tracked through four levels of ownership as follows:

• First level of ownership—any payment made to a legal entity that is owned in whole or in part by a person will be attributed to the person in an amount that represents the direct ownership interest in the first level or payment legal entity;  19

This direct final rule will remove part 1147, “Dairy Donation Program,” from title 7 of the CFR and make conforming amendments to part 1146, “Milk Donation Reimbursement Program.” The Dairy Donation Program (DDP) was established in 2021 under the authority of section 762 of the Consolidated Appropriations Act of 2021 (Pub. L. 116-260) (86 FR 48887; Sept. 1, 2021). Under the program, eligible dairy organizations that accounted to a Federal milk marketing order and incurred a qualified expense related to certain dairy product donations could apply for and receive reimbursements for those donations. The DDP was run along with an existing Milk Donation Reimbursement Program (MDRP). The MDRP is a USDA dairy milk donation program that was established as part of the 2018 Farm Bill (Pub. L. 115-334) to facilitate the donation of fluid milk products and avoid food waste (84 FR 46653; Sept. 5, 2019).

Like the MDRP, the DDP was intended to encourage the donation of dairy products and to prevent and minimize food waste. It was also created to assist in balancing the supply chain during the COVID-19 pandemic. The DDP is no longer funded by Congress; therefore, AMS has no authority to take further action under the DDP and its implementing regulations are obsolete.

In the DDP rulemaking, AMS made conforming changes to the MDRP regulations in part 1146 to allow the two programs to operate simultaneously (86 FR 48887; Sept. 1, 2021). With this recission of the DDP regulations, AMS is removing all references in part 1146 to “Dairy Donation and Distribution Plan” and replacing them with “Milk Donation and Distribution Plan”. AMS is also reverting the text of part 1146 to its form prior to the establishment of the DDP in September 2021 (the “2021 regulatory text”)—with three exceptions. First, rather than removing the definition of “qualified expense” (which was added to part 1146 when the DDP was established), AMS is revising the existing definition to remove the reference to dairy products, which are not eligible for reimbursement under MDRP.

Second, AMS is reverting the text of § 1146.102 to the 2021 regulatory text, except AMS is updating the words “new and continuing program participants” to “eligible partnerships,” which is the term currently used for participants, and eliminating the reference to published deadline.

Third, in § 1146.106, AMS is reverting to the 2021 regulatory text, with a few exceptions. In the paragraph (a) introductory text, AMS is reverting to the 2021 regulatory text but is removing the words “partner”, “qualified expenses,” and the term “report.” With this direct final rule, the term “report” is replaced with the term “Reimbursement Claim Form.” Removal of these words and the addition of “Reimbursement Claim Form” is in conformance with the current operation of MDRP. In the paragraph (a)(1) introductory text, AMS is retaining current regulatory text, aside from removing the reference to the DDP and replacing it with reference to the MDRP. AMS is doing so because the 2021 regulatory text required that participants submit a report for each month of the fiscal year. Under the current operation of the MDRP, eligible dairy organizations must submit the Form once; therefore, the retention of the current regulatory text will allow the current practice to continue. With respect to the subparagraphs to paragraph (a)(1), AMS is reverting to the 2021 regulatory text; however, AMS is not adding paragraph (a)(1)(v) back to the CFR. This paragraph, which required that reimbursement claims include applicable announced Federal milk marketing order prices for the month the milk was pooled, is not necessary because the information is now programmed to be automatically included. Finally, AMS is not reverting § 1146.106(a)(2) to the 2021 regulatory text. Under the current regulatory text, the documents act to “verify” the donations were made. The reporting requirements of the two versions are identical, however the current regulatory text refers to the Reimbursement Claim Form and Eligible Distributor Certification Form by title.

Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq. ) authorizes agencies to dispense with prior notice and comment for rules when the agency for “good cause” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without first publishing a proposed rule. Removing the DDP regulations and amending the MDRP regulations will provide transparency and may reduce confusion for dairy processors and other stakeholders. Further, AMS views this action as noncontroversial and anticipates no adverse public comment. This rule will become effective, as published in this document, July 28, 2025 without further action, unless adverse comments are received on or before June 30, 2025. Adverse comments are considered to be those comments that suggest the rule should not be adopted or suggest the rule should be changed.

If AMS receives adverse comments, we will publish a document in the Federal Register withdrawing this rule before the effective date. AMS will then publish a proposed rule for public comment. Following the close of that comment period, the comments will be considered, and a final rule addressing the comments will be published.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), AMS certifies that this direct final rule will not, if issued, have a significant economic impact on a substantial number of small entities. The DDP is no longer funded by Congress and is no longer in operation. The amendments made by the direct final rule will merely conform the CFR with AMS' current operating practices. This rule has been determined to be not significant for purposes of Executive Order 12866 and, therefore, has not been reviewed by OMB. The information collection associated with the DDP, approved under the Paperwork Reduction Act (44 U.S.C. chapter 35) under the OMB Control Number 0581-0327, will be discontinued. The forms required for participation in MDRP will continue to be used and are exempt from the Paperwork Reduction Act, as explained in the final rule establishing MDRP (84 FR 46653, 46657; Sept. 5, 2019).

It is not the interest of the public or USDA to maintain regulations that are obsolete. USDA has determined that there is no current reliance on this regulation. Further, USDA has determined the benefits of rescinding the DDP regulations and amending the MDRP regulations outweigh any cost associated with rescission.

For the reasons set forth in the preamble, AMS amends 7 CFR chapter X as follows:

AMS is rescinding the referendum procedures at 7 CFR part 1240 for the Sod Proposed Order issued December 10, 2024, (89 FR 99059). The Sod Proposed Order was authorized by the Commodity Promotion, Research, and Information Act of 1996 (1996 Act or Act) (7 U.S.C. 7411-7425). AMS initiated regulatory action upon receipt and review of a proposal from Turfgrass Producers International (TPI) on June 18, 2021, requesting the establishment of a natural grass sod research and promotion program (Program). The purpose of the Program was to maintain and expand markets for natural grass sod products. The Program would have been financed by an assessment on domestic sod producers.

As part of this rulemaking process, AMS initially published two proposed rulemakings in the Federal Register on October 16, 2023. The first rulemaking contained the Sod Proposed Order (88 FR 71306), and the second rulemaking proposed referendum procedures for the Sod Proposed Order (88 FR 71302). In both, AMS provided additional background on the industry and the need for the Program. On December 10, 2024, AMS issued a final rule, codifying the referendum procedures at part 1240 of title 7 of the CFR (89 FR 99059). On the same day, AMS published a proposed rulemaking and referendum announcing that it would be conducting an initial referendum among eligible producers to determine whether they favored establishing the Program (89 FR 99149). The proposed rulemaking stated that the Program would be established if it was favored by a majority of industry producers voting in the referendum.

AMS conducted the initial referendum from January 13, 2025, through February 11, 2025. To be eligible to vote, current natural grass sod producers must have sold natural grass sod products in the United States during the representative period from January 1, 2024, through December 31, 2024. The Sod Proposed Order would have been implemented if approved by a simple majority of producers voting in the referendum that had been engaged in the production and sale of natural grass sod products in the United States. In the referendum, 36.49 percent of those who voted favored implementation of the Sod Proposed Order. Therefore, the Sod Proposed Order failed the referendum vote. Accordingly, based upon the referendum results, AMS is rescinding 7 CFR part 1240, “Natural Grass Sod Promotion, Research, And Information Order; Referendum Procedures” because it is no longer needed.

The proposed rule codifying 7 CFR part 1240 did not meet the criteria of a “significant regulatory action” under Executive Order (E.O.) 12866, as amended by E.O. 13563, and this direct final rule to rescind that rule does not either. Therefore, the Office of Management and Budget (OMB) has not reviewed this rulemaking under those EOs.

On January 31, 2025, President Trump issued E.O. 14192, “Unleashing Prosperity Through Deregulation” (90 FR 9065). The E.O. states the policy of the executive branch is to be prudent and financially responsible in the expenditure of funds, from both public and private sources, and to alleviate unnecessary regulatory burdens placed on the American people. This action is considered an E.O. 14192 deregulatory action because it removes part 1240 from title 7 of the agency's regulations in the CFR.

In accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS is required to examine the impact of this rulemaking on small entities. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such action so that small businesses will not be disproportionately burdened. The affected industry falls under the North American Industry Classification System (NAICS) code: 111421—Nursery and Tree Production. The Small Business Administration (SBA) defines, in 13 CFR part 121, small agricultural producers in this industry as those having annual receipts of no more than $3,250,000. Using these criteria, under the Sod Proposed Order, most producers and handlers would be considered small businesses. However, pursuant to the requirements set forth in the RFA, it has been determined that this rulemaking will not have a significant economic impact on a substantial number of small entities. The Sod Proposed Order was never implemented. No additional cost or burden is expected to result from this action.

Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq. ) authorizes agencies to dispense with prior notice and comment for rules when the agency for “good cause” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without first publishing a proposed rule. Removing regulations at 7 CFR part 1240 will provide transparency and may reduce confusion among sod producers and other industry stakeholders. Further, AMS views this action as noncontroversial and anticipates no adverse public comment. This rule will become effective, as published in this document, July 28, 2025 without further action, unless adverse comments are received on or before June 30, 2025. Adverse comments are considered to be those comments that suggest the rule should not be adopted or suggest the rule should be changed.

If AMS receives adverse comments, we will publish a document in the Federal Register , withdrawing this rule before the effective date. AMS will then publish a proposed rule for public comment. Following the close of that comment period, the comments will be considered, and a final rule addressing the comments will be published.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the information collection requirements being terminated were approved previously by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0348. This direct final rule is deregulatory and so would not impose any additional information collection requirements; rather, it would reduce future collection requirements by removing reporting burdens.

The Department is committed to complying with the E-Government Act, 2002 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.

This direct final rule is deregulatory and has little effect on States and local governments, so AMS anticipates that this rule will not have implications for federalism. Therefore, under E.O. 13132, section 6(b), a federalism summary is not required. States and local governments are invited to comment if they believe a federalism summary is necessary.

This direct final rulemaking has been reviewed and meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, “Civil Justice Reform.” It is not intended to have a retroactive effect. The Commodity Promotion, Research, and Information Act of 1996 (1996 Act or Act) (7 U.S.C. 7411-7425) provides that the Act shall not affect or preempt any other Federal or State law authorizing promotion or research relating to an agricultural commodity.

Under section 519 of the Act, a person subject to an order may file a petition with USDA stating that an order, any provision of an order, or any obligation imposed in connection with an order, is not established in accordance with the law, and requesting a modification of an order or an exemption from an order. Any petition filed challenging an order, any provision of an order, or any obligation imposed in connection with an order, shall be filed within two years after the effective date of an order, provision or obligation subject to challenge in the petition. The petitioner will have the opportunity for a hearing on the petition. Thereafter, USDA will issue a ruling on the petition. The Act provides that the district court of the United States for any district in which the petitioner resides or conducts business shall be the jurisdiction to review a final ruling on the petition, if the petitioner files a complaint for that purpose not later than 20 days after the date of entry of USDA's final ruling.

This direct final rule has been reviewed under E.O. 13175, “Consultation and Coordination with Indian Tribal Governments,” which requires Federal agencies to consult and coordinate with Tribes on a government-to-government basis on: (1) policies that have Tribal implications, including regulations, legislative comments, or proposed legislation; and (2) other policy statements or actions that 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.

AMS has assessed the impact of this direct final rule on Indian Tribes and determined that this rulemaking would not have Tribal implications that require consultation under E.O. 13175. AMS hosts a quarterly teleconference with Tribal leaders where matters of mutual interest regarding the marketing of agricultural products are discussed. Information about the proposed regulation will be shared during an upcoming quarterly call, and Tribal leaders will be informed about the proposed regulation and referendum procedures. AMS will work with the USDA Office of Tribal Relations to ensure meaningful consultation is provided as needed with regards to the regulations.

In the Federal Register of January 17, 2025 (90 FR 5590), we amended the color additive regulations to add § 73.297 (21 CFR 73.297) “Myoglobin,” to provide for the safe use of myoglobin as a color additive in ground meat and ground poultry analogue products.

We gave interested persons until February 18, 2025, to file objections or requests for a hearing. We received no objections or requests for a hearing on the final order. Therefore, we find that the effective date of the final order that published in the Federal Register of January 17, 2025, should be confirmed.

I. Background

Upon request, FDA has classified the plazomicin test system as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On June 25, 2018, FDA received Microgenics Corporation's request for De Novo classification of the QMS Plazomicin Immunoassay. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on November 19, 2018, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 862.3460. 1 We have named the generic type of device plazomicin test system, and it is identified as a device intended to measure plazomicin in human specimens. Measurements obtained by this device are used in monitoring levels of plazomicin to ensure appropriate therapy in patients with complicated urinary tract infection.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding the quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 862 is amended as follows:

Upon request, FDA has classified the inherited nucleotide repeat disorder DNA test as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On April 18, 2019, FDA received Asuragen, Inc.'s request for De Novo classification of the AmplideX Fragile X Dx & Carrier Screen Kit. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on February 21, 2020, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 866.5970. 1 We have named the generic type of device inherited nucleotide repeat disorder DNA test, and it is identified as a prescription in vitro diagnostic device that is intended to detect and identify the number of nucleotide repeats in a gene using genomic DNA isolated from post-natal patient specimens. It is solely intended as an aid for carrier testing and as an aid for the diagnosis of inherited nucleotide repeat-associated disorders. Assay results are solely intended to be used in conjunction with other clinical and diagnostic findings. These tests do not include those indicated for use for fetal diagnostic testing or newborn screening.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

Upon request, FDA has classified Zika virus serological reagents as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On December 26, 2018, FDA received InBios International, Inc.'s request for De Novo classification of the ZIKV Detect 2.0 IgM Capture ELISA. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on May 23, 2019, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 866.3935. 1 We have named the generic type of device “Zika virus serological reagents,” and it is identified as in vitro diagnostic devices that consist of antigens or antibodies for the detection of Zika virus or Zika antibodies in human specimens from individuals who have signs and symptoms consistent with Zika virus infection and/or epidemiological risk factors. The detection aids in the diagnosis of current or recent Zika virus infection or serological status. Negative results obtained with this test do not preclude the possibility of Zika virus infection, past or present. Positive results should be interpreted with consideration of other clinical information and laboratory findings and should not be used as the sole basis for treatment or other patient management decisions.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding the quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

Upon request, FDA has classified the temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 & (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD & C Act, defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On April 2, 2019, FDA received Medi-Tate Ltd.'s request for De Novo classification of the iTind System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on February 25, 2020, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 876.5510. 1 We have named the generic type of device temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia, and it is identified as a prescription use device that is inserted transurethrally and deployed at the prostate. The implant is designed to increase prostatic urethral patency by increasing prostatic opening. It is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

At the time of classification, temporarily-placed urethral opening systems for symptoms of benign prostatic hyperplasia are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows:

The Coast Guard will enforce special local regulations in 33 CFR 100.501 for the Washington, DC Dragon Boat Festival regulated area from 7:30 a.m. to 6:30 p.m. on May 31, 2025. This action is being taken to provide for the safety of life on navigable waterways during this event. As stated in footnote one to table 2 to paragraph (i)(2), the enforcement dates and times for each of the listed events in the table are subject to change. Due to inclement weather, the Washington, DC Dragon Boat Festival has been rescheduled (for this year only) from the third weekend in May to May 31, 2025, for a one-day event. Our regulation for marine events within the Fifth Coast Guard District, § 100.501, specifies the location of the regulated area for the Washington, DC Dragon Boat Festival, which encompasses portions of the navigable waters of the Upper Potomac River. During the enforcement periods, as reflected in § 100.100(c), the operator of a vessel in the regulated area must comply with directions from the Patrol Commander or any Official Patrol displaying a Coast Guard ensign.

In addition to this notification of enforcement in the Federal Register, the Coast Guard plans to provide notification of this enforcement period via the Local Notice to Mariners and marine information broadcast.

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule under the authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. The sponsor did not notify the Coast Guard of this marine event with adequate time to provide a reasonable comment period and consider those comments before issuing the rule and establishing the safety zone by May 31, 2025.

Also, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be contrary to the public interest because immediate action is needed to ensure the safety of participants during the duration of the US Rowing Beach Sprints Mini Camp.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Sector, Eastern Great Lakes (COTP) has determined that a safety zone is required to ensure the safety of participants and the navigable waters before, during, and after the scheduled marine event.

This rule establishes a safety zone from 6:30 a.m. to 7:30 p.m. on May 31, 2025, and from 1:30 p.m. to 3:30 p.m. on June 1, 2025. The safety zone will cover all navigable waters and tributaries within 250 meters (820 ft) offshore Edgewater Park Beach. There will be 2 parallel lines of 3 buoy's perpendicular to shore extending 250 meters from water's edge. The boundaries of the safety zone form a rectangle with the four corners of the polygon located in the following positions: (1) 41°29′22″ N, 081°44′20″ W; (2) 41°29′29″ N, 081°44′25″ W; (3) 41°29′25″ N, 081°44′34″ W; (4) 41°29′18″ N, 081°44′29″ W. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the US Rowing Mini Camp is in session. No vessel or person will be 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.

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 section 3(f) of 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 size, location, and duration of rule. This safety zone would restrict navigation for a relatively small area near Edgewater Beach for the course area for 13 hours on one day, and 2 hours on the second day.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone that will restrict navigation through the course area for 13.0 hours one day, and 2.5 hours on the second day. 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 supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

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

I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port Sector Delaware Bay DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

On April 1, 2025, an organization notified the Coast Guard that it will be conducting a clay shoot from the decommissioned, historic Battleship New Jersey, in Camden, NJ, from 1 p.m. to 6 p.m. on June 26, 2025. The participants will fire bird shot at clay targets from the port side of the Battleship New Jersey into the Delaware River.

The Coast Guard is issuing this temporary rule under the authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable to do so. There is insufficient time to publish an NPRM, allow for a reasonable comment period, and publish a final rule, given that the rule must be in force by June 26, 2025 to serve its purpose.

Also, 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 . It is impracticable to delay the effective date of this rule because it must be in place by June 26 to serve its intended purpose.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port, Sector Delaware Bay (COTP) has determined that clay shoot from the Battleship New Jersey could pose a risk to waterway users if normal vessel traffic were allowed to transit within 800 feet of the Battleship New Jersey. Possible hazards include risks of injury or death from dangerous projectiles hitting vessels traversing through the regulated area.

This rule establishes a safety zone from 1 p.m. through 6 p.m. on June 26, 2025, or on a rain date no later than July 4, 2025. The specific date and time of any rain date will be published via Local Notice to Mariners and Broadcast Notice to Mariners. The safety zone will cover all navigable waters within 800 feet of the Battleship New Jersey, on the Delaware River, in Camden, NJ. The coordinates of the safety zone are provided in the proposed language of the rule, below. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled clay shoot. No vessel or person would be 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.

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 section 3(f) of 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 and duration of the regulated area, which would impact a small, designated area of the Delaware River. Vessels will be able to safely transit around the regulated area during the enforcement period. The Coast Guard will provide advance notification of the special local regulation to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners.

The regulatory flexibility analysis provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, do not apply this rule. They do not apply because this rule fits a 5 U.S.C. 553(b)(B) good-cause exception for notice-and-comment rulemaking, and rules not subject to notice and comment are not required to do regulatory flexibility analyses.

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 safety zone lasting only 5 hours that will prohibit entry within 800 feet of the Battleship New Jersey, on the Delaware River, in Camden, NJ. 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 supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

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

The Coast Guard will enforce a safety zone regulation in 33 CFR 165.929 for the Lakeshore State Park fireworks event in item 2 in Table 4 to § 165.929 from 10:00 p.m. to 11:30 p.m. on May 31, 2025. The regulation for recurring marine events within the State of Wisconsin in item 2 in Table 4 to § 165.929, specifies the location of the regulated area for this event. All vessels must obtain permission from the Captain of the Port (COTP) Lake Michigan, or designated on-scene representative to enter, move within, or exit this safety zone during the enforcement time listed in this notice of enforcement. Vessels and persons granted permission to enter the safety zone must obey all lawful orders or directions of the COTP Lake Michigan or designated representative. Upon being hailed by the U.S. Coast Guard by siren, radio, flashing light or other means, the operator of a vessel must proceed as directed.

In addition to this notification of enforcement in the Federal Register, the Coast Guard will provide the maritime community with notification of this enforcement period via Broadcast Notice to Mariners. The COTP Lake Michigan may be reached by contacting the Coast Guard Sector Lake Michigan Command Center at (414) 747-7182. An on-scene designated representative may be reached via VHF-FM Channel 16.

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule under the authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. On April 28, 2025, the United States (U.S.) Army notified the Coast Guard that it would be conducting training on June 7, 2025, involving Army personnel jumping from the deck of the museum vessel USS Lexington into Corpus Christi Bay. This safety zone must be established prior to the exercise to protect United States Army personnel, the public, vessels, and the marine environment from potential hazards created during this training exercise. The Coast Guard therefore lacks sufficient time to provide a reasonable comment period and then a period to consider those comments before issuing the rule.

Also, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be contrary to the public interest because prompt action is needed to respond to potential safety hazards associated with this U.S. Army training exercise.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Sector Corpus Christi (COTP) has determined that potential hazards associated with a jump training exercise on June 7, 2025, will be a safety concern for participating U.S. Army personnel and for anyone within the safety zone off the port side of the USS Lexington. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the exercise occurs.

This rule establishes a safety zone from 7 a.m. through 11 a.m. on June 7, 2025. The safety zone will cover all navigable waters within the area encompassed by a line connecting the following points: beginning at Point 1: 27°48′57.76″ N, 97°23′19.17″ W; thence to Point 2: 27°48′50.75″ N, 97°23′16.62″ W; thence to Point 3: 27°48′54.34″ N, 97°23′5.73″ W; thence to Point 4: 27°49′0.15″ N, 97°23′11.33″ W; thence returning to Point 1. No vessel or person will be permitted to enter the temporary safety zone during the period in which the rule is subject to enforcement without obtaining permission from the COTP or a designated representative, who may be contacted on Channel 16 (156.8 MHz) or by telephone at (361) 939-0450. The Coast Guard will issue Broadcast Notices to Mariners and Safety Marine Information Broadcasts to inform the public of these restrictions.

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.

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 section 3(f) of Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the size, location, and duration of the safety zone. The safety zone covers 1 quarter of a square mile area of the Corpus Christi Bay outside of the navigational channel, and vessels will be able to transit around this area unimpeded. The temporary safety zone will be subject to enforcement for a period of only four hours on June 7, 2025. Vessels may also be allowed to enter the zone during the enforcement period with prior approval of 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 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 will 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 establishing a temporary safety zone for navigable waters in Corpus Christi Bay lasting approximately four hours on one day. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created during a U.S. Army jump training exercise. 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 supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 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).

If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

EPA is issuing this rulemaking under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. FFDCA section 408(b)(2)(A)(i) allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” FFDCA section 408(b)(2)(A)(ii) 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. FFDCA section 408(b)(2)(C) 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 . . .”

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. If you fail to file an objection to the final rule within the time period specified in the final rule, you will have waived the right to raise any issues resolved in the final rule. 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 the docket ID number EPA-HQ-OPP-2020-0449 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 28, 2025.

The EPA's Office of Administrative Law Judges (OALJ), in which the Hearing Clerk is housed, urges parties to file and serve documents by electronic means only, notwithstanding any other particular requirements set forth in other procedural rules governing those proceedings. See “Revised Order Urging Electronic Filing and Service,” dated June 22, 2023, which can be found at https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf. Although the EPA's regulations require submission via U.S. Mail or hand delivery, the EPA intends to treat submissions filed via electronic means as properly filed submissions; therefore, the EPA believes the preference for submission via electronic means will not be prejudicial. When submitting documents to the OALJ electronically, a person should utilize the OALJ e-filing system at https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf.

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 at https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. If you wish to include CBI in your request, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice.

In the Federal Register of October 27, 2020 (85 FR 68030 (FRL-10015-86-OCSPP)), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0F8836) by Dow AgroSciences LLC (currently Corteva Agriscience, LLC), 9330 Zionsville Road, Indianapolis, IN. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide florylpicoxamid, (1S)-2,2-bis(4-fluorophenyl)-1-methylethyl N-[[3-(acetyloxy)-4-methoxy-2-pyridinyl]carbonyl]-L-alaninate in or on barley, bran at 0.2 parts per million (ppm); barley, grain at 0.05 ppm; barley, hay at 2.0 ppm; barley, straw at 0.9 ppm; beans, dried shelled (except soybean), straw at 0.9 ppm; beet, sugar, dried pulp at 0.4 ppm; beet, sugar, roots at 0.05 ppm; beet, sugar, tops at 0.3 ppm; pea and bean, dried shelled, except soybean, subgroup 6C at 0.02 ppm; pea, dried shelled, hay at 8.0 ppm; pea, dried shelled, vines at 3.0 ppm; rapeseed subgroup 20A, fodder/straw at 2.0 ppm; rapeseed subgroup 20A, seed at 0.04 ppm; wheat, aspirated grain fractions at 0.1 ppm; wheat, bran at 0.05 ppm; wheat, forage at 2.0 ppm; wheat, grain at 0.02 ppm; wheat, hay at 4.0 ppm; wheat, straw at 0.3 ppm; and in or on the raw agricultural commodity cattle, fat at 0.02 ppm; cattle, meat at 0.02 ppm; cattle, meat byproducts at 0.02 ppm; egg at 0.02 ppm; goat, fat at 0.02 ppm; goat, meat at 0.02 ppm; goat, meat byproducts at 0.02 ppm; hog, fat at 0.02 ppm; hog, meat at 0.02 ppm; hog, meat byproduct at 0.02 ppm; horse, fat at 0.02 ppm; horse, meat at 0.02 ppm; horse, meat byproduct at 0.02 ppm; milk at 0.02 ppm; poultry, fat at 0.02 ppm; poultry, liver at 0.02 ppm; poultry, muscle at 0.02 ppm; sheep, fat at 0.02 ppm; sheep, meat at 0.02 ppm; sheep, meat byproducts at 0.02 ppm. The Agency's notice of filing document referenced a summary of the petition prepared by Corteva Agriscience, LLC, the registrant, which is available in the docket. Two comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA has modified several tolerance expressions, the tolerances, and commodity definitions. The reasons for these changes are explained in this document.

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), 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 florylpicoxamid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with florylpicoxamid follows.

EPA has evaluated the available toxicity data and considered its 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. Florylpicoxamid is a picolinamide fungicide that inhibits the quinone oxidase enzyme of Complex III in the mitochondrial electron transport chain, leading to disruption of cellular respiration. A mammalian mode of action is not known. The studies available in the toxicity database indicate that toxicity is low for florylpicoxamid and are protective of toxicity from mammalian metabolites of florylpicoxamid. The only adverse effects were observed in a 90-day oral study in dogs, a developmental study in rabbits, and a combined chronic/carcinogenicity study in rats. In the other studies, effects were not observed at the highest doses tested, ranging from 123 mg/kg/day to the limit dose of 1000 mg/kg/day. The systemic effect of decreased body weight, an effect common to the picolinamide chemical class, was the most consistent seen throughout the database.

Adaptive liver effects including increased liver weights and very slight to slight hepatocellular hypertrophy were among the most common observations in the florylpicoxamid database. In the absence of corroborating toxic effects such as clinical chemistry ( e.g., liver enzymes) or other histopathological changes ( e.g., hepatocellular necrosis and inflammation), these effects are considered an adaptive response of the liver as it activates to metabolize the xenobiotic, rather than being adverse.

No increased fetal or offspring susceptibility was observed in developmental toxicity studies in rats and rabbits or in reproductive and fertility effects studies in rats. The only effect of note in those studies was late abortions seen in two maternal rabbits.

No evidence of neurotoxicity or immunotoxicity was seen throughout the toxicity database for florylpicoxamid, and a non-guideline 90-day oral study in rats that evaluated these systems did not reveal treatment-related effects up to the highest dose tested (185 mg/kg/day). No toxicity was seen up to the limit dose in a 28-day dermal study. Florylpicoxamid has low acute oral, inhalation, and dermal toxicity, and is not a skin or eye irritant (Toxicity Category IV, except for oral and dermal Toxicity Categories of III), or a skin sensitizer.

Specific information on the studies received and the nature of the adverse effects caused by florylpicoxamid as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found in the document “Florylpicoxamid: Human Health Risk Assessment for the New Active Ingredient” at pages 20-23 in docket ID number EPA-HQ-OPP-2020-0449.

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 NOAEL and the LOAEL. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https://www.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.

For more detailed information on the toxicological endpoints for florylpicoxamid used for human risk assessment can be found in the document “Florylpicoxamid Human Health Risk Assessment for the New Active Ingredient” in docket ID number EPA-HQ-OPP-2020-0449.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to florylpicoxamid, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from florylpicoxamid in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for florylpicoxamid; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America (USDA 2005-2010 NHANES/WWEIA). As to residue levels in food, EPA conducted a partially refined chronic aggregate dietary (food and drinking water) exposure and risk assessment and incorporated 100% crop treated (PCT) for all commodities. The chronic dietary exposure analysis incorporated recommended tolerances for livestock commodities, as the residues of concern for both tolerance enforcement and risk assessment are the same in livestock. While the residue of concern for tolerance enforcement in plants is parent florylpicoxamid only, the residues of concern for risk assessment are florylpicoxamid and metabolite X12485649. Therefore, to account for the residues of concern for risk assessment, the chronic dietary exposure analysis incorporated average field trial residues of florylpicoxamid and metabolite X12485649 for all plant commodities (raw and processed) in this action.

The analysis incorporated default processing factors. Additionally, the submitted wheat and barley residue data demonstrate that residues of X12485649 concentrate in wheat bran and barley bran. Therefore, anticipated residues of 0.054 ppm and 0.051 ppm based on the residues of concern for risk assessment were used for barley bran and wheat bran, respectively.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that florylpicoxamid does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is not required.

iv. Anticipated residue and PCT information. EPA did not use PCT information in the dietary assessment for florylpicoxamid. Tolerance level residues were assumed for all livestock commodities. 100 PCT was assumed for all crop commodities.

Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for florylpicoxamid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of florylpicoxamid. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment.

Based on the Pesticide in Water Calculator model (PWC Version 2.001), which utilizes the Pesticide Root Zone Model (PRZM5) and the Variable Volume Water Model (VVWM), the estimated drinking water concentrations (EDWCs) of florylpicoxamid residues of concern for acute exposures are estimated to be 37.5 parts per billion (ppb) for surface water and 318 ppb for ground water. EDWCs for chronic exposures for non-cancer assessments are estimated to be 32 ppb for surface water and 212 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 212 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Florylpicoxamid is not currently registered for any specific use patterns that would result in residential handler exposure, but there are residential post-application exposures expected from contact with previously treated turf on golf courses. There is the potential for dermal post-application exposure for youth (11 to <16 years old) and adults exposed as a result of golfing on treated turf. Residential post-application exposure is expected to be short-term in duration. Intermediate-term exposures are not likely. Dermal exposures only are anticipated while golfing on treated turf; however, there is no dermal endpoint selected for children. Therefore, only dermal exposures for adults and youths (11 to <16 years old) have been quantitatively assessed and there are no additional routes to combine.

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.”

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to florylpicoxamid and any other substances. For the purposes of this tolerance action, therefore, EPA has assumed that florylpicoxamid does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework.

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. No increased prenatal or postnatal susceptibility was detected in developmental or reproductive studies in rats and rabbits, as no fetal or offspring effects were observed in either study. The late abortions observed in rabbit are considered a maternal effect only.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for florylpicoxamid is complete.

ii. There is no indication that florylpicoxamid is a neurotoxic chemical, and there is no need for a developmental neurotoxicity study or additional Uncertainty Factors to account for neurotoxicity.

iii. There is no evidence that florylpicoxamid results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the two-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The partially refined chronic dietary assessment utilized tolerance-level residues for livestock commodities, field trial residue data for all plant commodities (raw and processed) to account for residues of concern for risk assessment, 100 PCT, and default processing factors. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to florylpicoxamid in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by florylpicoxamid.

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, florylpicoxamid 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 florylpicoxamid from food and water will utilize 4.3% of the cPAD for females 13-49 years old the population group with the highest risk estimate. The population subgroup with the highest dietary exposure is all infants (<1 year old), with an exposure of 0.016275 mg/kg/day at 3.5% of the cPAD. As there are no anticipated long-term residential exposures based on the explanation in Unit III.C.3., the chronic aggregate assessment is equivalent to the chronic dietary assessment.

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).

Florylpicoxamid is currently 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 florylpicoxamid.

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 2,200 for adults and 2,900 for youth (11 to <16 years). Dermal exposures only are anticipated while golfing on treated turf. Because EPA's level of concern for florylpicoxamid 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). Because there are no residential exposure scenarios which are expected to be intermediate-term, florylpicoxamid is not expected to pose an intermediate-term risk.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, florylpicoxamid 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 florylpicoxamid residues.

The petitioner has proposed a multi-residue method (quick, easy, cheap, effective, rugged and safe; QuEChERS; JRFA Method No. AU298R0) for the determination of florylpicoxamid in plant and livestock commodities.

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

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established MRLs for florylpicoxamid.

Two comments were received in response to the October 27, 2020, notice of filing. One comment was from Sheryl Kunickis, Ph.D., Director at the United States Department of Agriculture in support of the petition, discussing reported efficacy of florylpicoxamid, describing it as having “excellent foliar uptake and redistribution properties on dicot and monocot plants, as well as excellent curative reachback activity” and being “highly active against a broad spectrum of diseases”. Dr. Kunickis discussed the benefits of florylpicoxamid as a novel mode of action with no cross resistance and states “[b]ased on its reported efficacy and novel mode of action, USDA believes that florylpicoximide [ sic ] demonstrates potential to serve as a beneficial new tool for U.S. growers.” The Agency appreciates the supportive comments from Dr. Kunickis, and one additional Anonymous commenter, and is moving forward with issuing the tolerance.

Based on EPA's review of the data supporting the petition, EPA is establishing tolerances that vary from what the petitioner requested under its authority in FFDCA section 408(d)(4)(A)(i). Some commodity terms are altered to be consistent with Agency nomenclature and to reflect the crop group definition updates from 2022. EPA is not establishing tolerances on barley, bran; beet, sugar, dried pulp; wheat, aspirated grain fractions; and wheat, bran. The Agency determined that the residue of concern is parent only and parent did not concentrate in these processed commodities. Therefore, separate tolerances are not required as they are covered by the tolerances on the associated raw agricultural commodities.

EPA is removing the plant metabolite X12485649 as a residue of concern for tolerance enforcement for plants. Both parent and metabolite X12485649 were the major residues in plant metabolism studies, and both were found in quantifiable amounts in magnitude of the residue for crops. Residues of parent florylpicoxamid would be sufficient to detect misuse and serve as the residue of concern for tolerance enforcement for plants. Therefore, the tolerance expression for plant commodities is parent only.

To support the updated 2022 crop group definitions, EPA updated the crop commodity definitions by changing pea and bean, dried shelled, except soybean, subgroup 6C to vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E and vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F; and pea, dried shelled, vines and pea, dried shelled, hay to vegetable, legume, forage and hay, except soybean, subgroup 7-22A. EPA also corrected the commodity definitions by changing poultry, muscle to poultry, meat, and beet, sugar, tops to beet, sugar, leaves. To align with the labeled uses, the Agency is not establishing tolerances on the full rapeseed subgroup 20A and is instead establishing a tolerance only on canola.

EPA is establishing tolerance levels lower than what the petitioner requested for barley, grain corrected to 0.03 ppm, barley, hay to 1.5 ppm, barley, straw to 0.5 ppm, beet, sugar, leaves to 0.1 ppm, beet, sugar, roots to 0.01 ppm, vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E to 0.01 ppm, vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F to 0.01 ppm, vegetable, legume, forage and hay, except soybean, subgroup 7-22A to 6 ppm, rapeseed subgroup 20A to 0.015 ppm, wheat, forage to 1.5 ppm, wheat, grain to 0.01 ppm, wheat, hay to 3 ppm, and wheat, straw to 0.05 ppm. This corrects for the plant residue of concern for tolerance expression being the florylpicoxamid parent compound only.

Therefore, tolerances are established for residues of florylpicoxamid, (1 S )-2,2-bis(4-fluorophenyl)-1-methylethyl N -[[3-(acetyloxy)-4-methoxy-2-pyridinyl]carbonyl]-L-alaninate, in or on barley, grain at 0.03; barley, hay at 1.5; barley, straw at 0.5; beet, sugar, leaves at 0.1; beet, sugar, roots at 0.01; vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E at 0.01; vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F at 0.01; vegetable, legume, forage and hay, except soybean, subgroup 7-22A at 6; canola at 0.015; wheat, forage at 1.5; wheat, grain at 0.01; wheat, hay at 3; wheat, straw at 0.05 ppm. Tolerances are established for residues of florylpicoxamid, (1 S )-2,2-bis(4-fluorophenyl)-1-methylethyl N -[[3-(acetyloxy)-4-methoxy-2-pyridinyl]carbonyl]-L-alaninate, and its metabolite, (2 S )-1,1-bis(4-fluorophenyl)propan-2-yl N -[(3-hydroxy-4-methoxypyridin-2-yl)carbonyl]-L-alaninate, in or on cattle, fat at 0.02; cattle, meat at 0.02; cattle, meat byproducts at 0.02; egg at 0.02; goat, fat at 0.02; goat, meat at 0.02; goat, meat byproducts at 0.02; hog, fat at 0.02; hog, meat at 0.02; hog, meat byproducts at 0.02; horse, fat at 0.02; horse, meat at 0.02; horse, meat byproducts at 0.02; milk at 0.02; poultry, fat at 0.02; poultry, liver at 0.02; poultry, meat at 0.02; sheep, fat at 0.02; sheep, meat at 0.02; sheep, meat byproducts at 0.02 ppm.

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

This action is exempt from review under Executive Order 12866 (58 FR 51735, October 4, 1993), because it establishes or modifies a pesticide tolerance or a tolerance exemption under FFDCA section 408 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.

Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply because actions that establish a tolerance under FFDCA section 408 are exempted from review under Executive Order 12866.

This action does not impose an information collection burden under the PRA 44 U.S.C. 3501 et seq., because it does not contain any information collection activities.

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

This action does not contain an unfunded mandate of $100 million or more (in 1995 dollars and adjusted annually for inflation) as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any State, local, or Tribal governments or on the private sector.

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

This action does not have Tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have substantial direct effects on Tribal governments, on the relationship between the Federal Government and the Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because tolerance actions like this one are exempt from review under Executive Order 12866.

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

This action does not involve technical standards that would require Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.

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

For the reasons set forth in the preamble, EPA is amending 40 CFR chapter I as follows:

I. Background

In FR Doc. 2025-06008 of April 15, 2025 (90 FR 15792), there were a few technical and typographical errors that are identified and corrected in this correcting document. The corrections in this correcting document are applicable to the effective date beginning June 3, 2025, as if they had been included in the document that appeared in the April 15, 2025, Federal Register .

On page 15899, we made an error in the CMS identification number of a collection of information request.

On page 15903, we made errors in Table 11 which provides the summary of the transfers and costs for the final rule. For the entry regarding costs, we made errors in the first year and year range of the costs.

Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rule in the Federal Register before the provisions of a rule take effect. Specifically, 5 U.S.C. 553 requires the agency to publish a notice of the proposed rule in the Federal Register that includes a reference to the legal authority under which the rule is proposed, and the terms and substance of the proposed rule or a description of the subjects and issues involved. Further, 5 U.S.C. 553 requires the agency to give interested parties the opportunity to participate in the rulemaking through public comment on a proposed rule. Similarly, section 1871(b)(1) of the Social Security Act (the Act) requires the Secretary to provide for notice of the proposed rule in the Federal Register and provide a period of not less than 60 days for public comment for rulemaking to carry out the administration of the Medicare program under title XVIII of the Act. In addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) of the Act mandate a 30-day delay in effective date after issuance or publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the notice and comment and delay in effective date APA requirements. In cases in which these exceptions apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act also provide exceptions from the notice and 60-day comment period and delay in effective date requirements of the Act. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an agency to dispense with normal rulemaking requirements for good cause if the agency makes a finding that the notice and comment process are impracticable, unnecessary, or contrary to the public interest. In addition, both section 553(d)(3) of the APA and section 1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay in the effective date where such delay is contrary to the public interest and an agency includes a statement of support.

We believe that this correcting document does not constitute a rule that would be subject to the notice and comment or delayed effective date requirements of the APA or section 1871 of the Act. This correcting document corrects typographical and technical errors in the preamble of the final rule but does not make substantive changes to the policies that were adopted in the final rule. As a result, this correcting document is intended to ensure that the information in the final rule accurately reflects the policies adopted in that final rule.

In addition, even if this were a rule to which the notice and comment procedures and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the regulatory text correction in this document into the final rule or delaying the effective date would be unnecessary, as we are not altering our policies or regulatory changes, but rather, we are simply implementing the policies and regulatory changes that we previously proposed, requested comment on, and subsequently finalized.

This final rule correcting document is intended solely to ensure that the final rule accurately reflects policies and regulatory changes that have been adopted through rulemaking. Furthermore, such notice and comment procedures would be contrary to the public interest because it is in the public's interest to ensure that the final rule accurately reflects our policies. Therefore, we believe we have good cause to waive the notice and comment and effective date requirements.

In FR Doc. 2025-06008 of April 15, 2025 (90 FR 15792), make the following corrections:

1. On page 15899, second column, third full paragraph, lines 4 and 5, the parenthetical reference “(CMS-10662)” is corrected to read “(CMS-10062)”.

2. On page 15903, top half of the page, in the table titled “Table 11—Summary of the Transfers and Costs of the Final Rule by Provision and Year”, the fourth row (COSTS),

a. Second column, the year “2026” is corrected to read “2025”.

b. Last column, the years “2026-2035” are corrected to read “2025-2034”.

Executive Summary

Why we need to publish a rule. Under the Act, a species warrants delisting if it no longer meets the definition of an endangered species (in danger of extinction throughout all or a significant portion of its range) or a threatened species (likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range). The Colorado hookless cactus is listed as a threatened species, and we are delisting it. Delisting a species can be completed only by issuing a rule through the Administrative Procedure Act rulemaking process (5 U.S.C. 551 et seq. ).

What this document does. We are delisting the Colorado hookless cactus because the species has recovered to the point at which it no longer meets the definition of an endangered or threatened species.

The basis for our action. Under the Act, we may determine that a species is an endangered species or a threatened species because of any of five factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. The determination to delist a species must be based on an analysis of the same factors.

Under the Act, we must review the status of all listed species at least once every 5 years. We must delist a species if we determine, on the basis of the best available scientific and commercial data, that the species is neither a threatened species nor an endangered species. Our regulations at 50 CFR 424.11(e) identify four reasons why we might determine a species shall be delisted: (1) The species is extinct, (2) the species has recovered to the point at which it no longer meets the definition of an endangered species or a threatened species, (3) new information that has become available since the original listing decision shows the listed entity does not meet the definition of an endangered species or a threatened species, or (4) new information that has become available since the original listing decision shows the listed entity does not meet the definition of a species. Here, we have determined that the Colorado hookless cactus has recovered to the point at which it no longer meets the definition of an endangered species or a threatened species; therefore, we are delisting it.

Please refer to the proposed rule to delist the Colorado hookless cactus published on April 11, 2023 (88 FR 21582), for a detailed description of previous Federal actions concerning this species.

A species status assessment (SSA) team prepared the SSA report for Colorado hookless cactus to inform the 2021 5-year review and updated it in 2024. The SSA team was composed of Service biologists, in consultation with other species experts. The SSA report represents a compilation of the best scientific and commercial data available concerning the status of the species, including the impacts of past, present, and future factors (both negative and beneficial) affecting the species.

In accordance with our joint policy on peer review published in the Federal Register on July 1, 1994 (59 FR 34270), and our August 22, 2016, memorandum updating and clarifying the role of peer review of listing and recovery actions under the Act ( https://www.fws.gov/sites/default/files/documents/peer-review-policy-directors-memo-2016-08-22.pdf ), we solicited independent scientific review of the information contained in the Colorado hookless cactus SSA report. As discussed in the proposed rule, we sent the SSA report to five independent peer reviewers and received three responses. The peer reviews can be found at https://www.regulations.gov. In preparing the proposed rule, we incorporated the results of these reviews, as appropriate, into the SSA report, which was the foundation for the proposed rule and this final rule. A summary of the peer review comments and our responses can be found in the proposed rule (88 FR 21582, April 11, 2023).

We considered all comments and information we received during the comment period on our proposed rule to delist Colorado hookless cactus (88 FR 21582, April 11, 2023). This consideration resulted in the following changes from the proposed rule and draft post-delisting monitoring (PDM) plan to this final rule and the updated PDM plan.

In this final rule, we changed the scientific name Sclerocactus dawsonii to S. dawsoniae based on taxonomic nomenclature standards and a recently published article establishing it as a new species (McGlaughlin and Naibauer 2024, entire).

In the proposed rule and SSA version 1.1, we reported a minimum population estimate of 103,086 plants for Sclerocactus glaucus with a 90 percent lower confidence level estimate of 68,120 plants (88 FR 21582 at 21592, April 11, 2023; Service 2022, p. 14). We now consider the 90 percent lower confidence value of 68,120 plants to be a better reflection of the minimum population estimate for the S. glaucus total population size than the mean estimate of 103,086 plants provided by the Bureau of Land Management (BLM) (Krening et al. 2021a, p. 8), as this allows us to be more conservative given the less comprehensive sampling in the study that produced these estimates (as compared to the sampling effort from the S. dawsoniae study (see Current Condition; Service 2025, pp. 20-21)).

Similarly, in the proposed rule and SSA version 1.1, we reported a minimum population estimate of 31,867 and the 90 percent lower confidence level estimate of 21,058 plants for Sclerocactus dawsoniae (88 FR 21582 at 21592, April 11, 2023; Service 2022, p. 14). This minimum population estimate was derived using S. glaucus macroplot estimates as a surrogate for S. dawsoniae (Krening et al. 2021a, p. 8). We have updated in this rule the minimum population estimate for S. dawsoniae to 17,362 plants based on a BLM technical report that used S. dawsoniae data to derive the estimate (Krening and Holsinger 2024, entire). We consider the updated minimum population estimate to better reflect S. dawsoniae' s total population size. We also provide additional explanation of the BLM methodology to derive population estimates for both species. We note that the updated minimum population estimates do not necessarily reflect a change in the species' numbers per se, but rather an improvement in the accuracy of information about their population sizes.

In this final rule we have also provided additional information about protections afforded to BLM sensitive species, and livestock grazing effects to Colorado hookless cactus, in our pessimistic future scenario.

In this final rule, we no longer consider or rely on the protections identified in the 2012 livestock grazing programmatic biological opinion for Colorado hookless cactus (Service 2012, entire). Once this final rule goes into effect, the grazing terms and conditions identified in the biological opinion will not apply to S. glaucus or S. dawsoniae. Therefore, in this rule we do not mention the protections afforded to Colorado hookless cactus under the programmatic biological opinion, as these protections have no bearing on our determination of the status of the listed entity under the Act.

We have also revised the PDM plan by updating the baseline densities for both species with 2022 and 2023 trend monitoring data (Service 2024, entire). We and our partners will use the baseline densities to track the trend of the species over the PDM timeframe.

In the proposed rule published on April 11, 2023 (88 FR 21582), we requested that all interested parties submit written comments on the proposal by June 12, 2023. We also contacted appropriate Federal and State agencies, scientific experts and organizations, and other interested parties and invited them to comment on the proposal. On April 10, 2023, we published a press release on our website inviting the public to comment. Newspaper notices inviting the general public to comment were published in the Grand Junction Daily Sentinel. We did not receive any requests for a public hearing. We received 13 public comments addressing the proposed rule, representing 10 individuals and 3 organizations. All substantive information received during the comment period has either been incorporated directly into this final determination or is addressed below.

Comment (1): Several commenters stated that invasive species can negatively affect survival and recruitment of Colorado hookless cactus and increase the risk of fire in the species' habitat, and that invasive species were underrepresented in the current and future condition analyses of Colorado hookless cactus. One commenter stated that we relied on optimistic measures to support delisting even though invasive species could have greater effects in the future.

Response (1): The commenters did not provide information to support their comment or suggestions for how to better represent the negative effects of invasive species in our analysis. The BLM Colorado hookless cactus technical assessment and habitat condition analysis provide the best scientific and commercial data available to examine current invasive species levels within Colorado hookless cactus analysis units (AUs) and potential effects to the species (Krening and Dawson 2020, p. 35; Holsinger and Krening 2021, entire). According to this information, current invasive species levels do not negatively affect the species or habitat quality at the AU level. Only individual plants experience detrimental effects of invasive weeds in localized areas (Service 2025, pp. 16-21; Krening and Dawson 2020, p. 35). We also evaluated future increases in effects from invasive species in combination with other stressors (livestock grazing, off-highway-vehicle (OHV) use, oil and gas development, utility corridor development and climate change) in our pessimistic future scenario (see Future Scenarios and Future Condition ).

While fire extent and severity may increase as invasive species cover increases, wildfires within the range of Colorado hookless cactus have resulted in only very localized impacts to both species. One example of a recent fire is the Logan Fire in the Roan Creek AU in 2023 that killed 11 plants (Freitag 2023, pers. comm.; Service 2025, pp. 37-38); this number represents far less than 1 percent of S. dawsoniae plants in an AU that has a minimum population estimate of 14,901. The Logan Fire was small in extent despite the high levels of invasive plant cover in the area (Service 2025, appendix 1). We expect both species will continue to experience localized effects from fire in the future. The majority of their habitat is sparsely vegetated; both species are widely dispersed across the landscape; and their ranges contain many barriers such as canyons, roads, and rivers that serve as firebreaks despite potential future increases in invasive species cover.

Comment (2): Several commenters stated that the BLM minimum population size estimates for Colorado hookless cactus are not reliable because the monitoring plot (macroplot) locations were subjectively selected by the researchers. One commenter recommended that we carefully evaluate the validity of the study before delisting the species, and another commenter considered our reliance on the BLM population size estimates to delist Colorado hookless cactus to be arbitrary and capricious.

Response (2): We disagree with the commenters that the Colorado hookless cactus minimum population size estimates are arbitrary and capricious and not reliable. We used the S. glaucus minimum population size estimates reported in a published peer-reviewed journal article (Krening et al. 2021a, entire). The sampling methods and analysis in this study—rather than reliance on census counts—are commonly used for plants with large populations sizes (Elzinga et al. 1999, pp. 37-38, 61-88). In this final rule, we relied on the S. dawsoniae minimum population size estimates reported in a BLM Technical Note with S. dawsoniae data (Krening and Holsinger 2024, entire) that used the same methodology as the published study (Krening et al. 2021a, entire) and received internal peer review.

We consider the BLM methods and population estimates of Krening et al. 2021a (entire) and Krening and Holsinger 2024 (entire) to be better and more reliable than earlier methods and population estimates. The BLM methods have been peer reviewed, were systematically implemented rangewide, and provide minimum population estimates that are smaller than the actual population size. Earlier methods were not peer reviewed and were applied inconsistently across the species' range with data collected opportunistically from different sources. While macroplots were placed subjectively for both species, transect locations within macroplots were randomly selected and represent a variety of habitat conditions for Colorado hookless cactus according to the BLM's habitat condition index. We relied on the minimum population estimates that were conservatively based on the transect data (see Current Condition ). We consider the S. glaucus and S. dawsoniae minimum population estimates to be reliable and the best scientific information available, and we are not aware of better estimates of population size for the two species. Therefore, we continue to rely on the Colorado hookless cactus minimum population size estimates provided by the studies mentioned herein (Krening et al. 2021a, entire; Krening and Holsinger 2024, entire; Holsinger and Krening 2024, entire; Service 2025, pp. 13-14, 24-27). Furthermore, the PDM plan relies on the sampling protocols in Krening et al. (2021a, entire).

Comment (3): Several commenters stated that the SSA report and proposed rule downplayed the effects and future risk of oil and gas development on S. dawsoniae and failed to analyze the cumulative impacts of this and other stressors. The commenters considered widespread habitat degradation and a downward trend to be likely for S. dawsoniae because the entire population is subject to oil and gas leasing, there are producing wells throughout its range, and over half of its range is unprotected from development.

Response (3): We review the best scientific and commercial information available when conducting a threats analysis. The identification of factors that could impact a species negatively is not sufficient to compel a finding that listing (or maintaining a currently listed species) on the Federal Lists of Endangered and Threatened Wildlife and Plants is appropriate. In determining whether a species meets the definition of a threatened or endangered species, we must evaluate all identified threats by considering the species' expected response and the effects of the threats—in light of those actions and conditions that will ameliorate the threats—on an individual, population, and species level, as well as the cumulative effect of the threats (see Regulatory Framework ).

The commenters did not provide additional information to support their comment. As we discuss below, leased areas do not equate to areas of surface disturbance; only small subsets of these areas are actively being explored or developed (see Stressors ). We evaluated current and future scenarios with the SSA framework, which analyzes the cumulative impact of stressors on the species (see Cumulative Impacts). We evaluated the potential for increases in oil and gas development, along with other stressors, in the pessimistic future scenario, and found that the loss of resiliency for S. dawsoniae AUs will be modest and no major changes in redundancy or representation are expected (see Future Scenarios and Future Condition ).

Comment (4): Two commenters questioned the protections afforded to Colorado hookless cactus by its designation as a BLM sensitive species. The first commenter cited an oil and gas project that resulted in the loss of 53 plants of another BLM sensitive species, Harrington's beardtongue ( Penstemon harringtonii ), as evidence of the limited protections that designation provides. The first commenter was concerned that we are considering only the species-level viability when evaluating the status of Colorado hookless cactus. The second commenter stated that we do not acknowledge the risk of losing the BLM 200-meter (m) 656 feet (ft) avoidance buffer for oil and gas development if Colorado hookless cactus is delisted.

Response (4): We disagree with the first commenter that we can expect the loss of Colorado hookless cactus populations despite its designation as a BLM sensitive species. The example provided by the commenter identifies localized, not population-level, loss of Harrington's beardtongue. We assess the viability of Colorado hookless cactus at the population and species levels as described in the Analytical Framework section, below. We acknowledge that the avoidance buffer for Colorado hookless cactus on BLM lands will decrease from the 200 m (656 ft) applied to federally listed plant species to 100 m (328 ft) afforded to BLM sensitive species for oil and gas development and other surface-disturbing activities (see Conservation Efforts and Regulatory Mechanisms ). In addition, BLM has discretion to relocate proposed energy development projects up to and beyond 200 m (656 ft) for BLM sensitive species in areas with a controlled surface use stipulation (see Conservation Efforts and Regulatory Mechanisms, below).

Comment (5): Several commenters provided a published journal article about dust effects to a federally listed plant in Utah outside of Colorado hookless cactus' range that estimated 2.5 tons of dust are deposited along a road corridor every year (Lewis et al. 2017, p. 431). Commenters stated that there is no substantive discussion or evaluation of dust effects to S. dawsoniae in the SSA report and proposed rule.

Response (5): We considered dust effects to both species in the SSA report as a stressor that is generated from multiple threats, including oil and gas development, OHV recreational use, and utility corridors. The best available information indicates that dust is not negatively impacting S. glaucus or S. dawsoniae at the population or species levels (Service 2025, pp. 17-18). The Lewis et al. (2017) paper specifically mentions the estimated dust deposition reported by the commenters is a generalization and was not measured. We note that the commenters provided information on dust effects for other species and locations but did not provide new information on dust within the ranges of S. glaucus or S. dawsoniae or dust effects specific to the two species.

Comment (6): Several commenters stated that our analysis in the SSA report and proposed rule underestimated the effects of livestock grazing on Colorado hookless cactus and ignored the best available science regarding this stressor. Commenters were concerned that livestock grazing may pose a demographic threat at the population level for Colorado hookless cactus because cattle can uproot and crush larger plants crucial to reproduction and cactus occurrences have been extirpated by concentrated sheep use. Additionally, several commenters stated that many grazing allotments within the Colorado hookless cactus' range do not meet BLM land health assessment standards.

Response (6): We considered the effects of livestock grazing to both species in the SSA report. Despite some grazing allotments within the two species' ranges not meeting BLM land health assessment standards, the best available information indicates that livestock grazing is not negatively impacting S. glaucus or S. dawsoniae at the population or species level (see Stressors, below; Service 2025, pp. 16-19). The BLM rangeland health assessment standards are not tailored to Colorado hookless cactus; rather, they describe specific conditions needed for public land health, such as the presence of streambank vegetation and adequate canopy or ground cover (43 CFR part 4100, subpart 4180). In the pessimistic scenario in the SSA report, we considered the potential for increased impacts from livestock grazing into the future. Even in this scenario, we project high or moderate resiliency in all but one of the S. glaucus AUs and in both S. dawsoniae AUs. We note that the commenters provided information on livestock grazing effects for other species and locations but did not provide new information on livestock grazing within the ranges of S. glaucus or S. dawsoniae or evidence of livestock grazing effects specific to the two species.

Comment (7): One commenter stated that BLM would not provide any restrictions on their lands for livestock grazing if the two Sclerocactus species were delisted.

Response (7): We disagree with the commenter that BLM would not provide any restrictions on their lands for livestock grazing if the two species were delisted. BLM administers special land management designations called Areas of Critical Environmental Concern (ACECs). Across the range of S. glaucus and S. dawsoniae, BLM has 11 ACECs, including 5 totaling 18,093 acres (ac) (7,321 hectares (ha)) where livestock use is managed or prohibited to benefit listed and BLM sensitive species in all or part of the management area (the River Rims, Escalante Canyon, Adobe Badlands, Pyramid Rock, and Atwell Gulch ACECs; see Stressors ). In addition, on lands without special designations, BLM includes standard permit terms and conditions for their livestock grazing permits such as seasonal utilization levels, reductions due to drought or fire, and other restrictions on open grazing (see Conservation Efforts and Regulatory Mechanisms ). These measures are not dependent on the listed status of Colorado hookless cactus.

Comment (8): Two commenters stated that we did not consider any levels of increased livestock grazing in our pessimistic future scenario or the cumulative impacts from climate change, invasive species, oil and gas development, and OHV recreation.

Response (8): We included a plausible range of livestock grazing levels on BLM lands in our future scenarios, including an increase in effects from livestock grazing on Colorado hookless cactus habitat and individuals in the pessimistic future scenario. Even in this pessimistic scenario, S. glaucus is projected to maintain high or moderate resiliency for all but one AU, and S. dawsoniae is projected to maintain high or moderate resiliency in both AUs, along with continued redundancy and representation for both species. Regarding our evaluation of cumulative effects, see our response to Comment (3), above.

Comment (9): One commenter stated that we failed to consider the well-known impacts of livestock grazing on biological soil crusts (BSCs) that influence water availability, nutrient cycling, and soil erosion in semi-arid high-elevation deserts; nor did we consider the severity of future drought conditions caused by climate change. However, the commenter acknowledged that BSCs are difficult to detect and their reductions by livestock grazing may not be readily apparent. The commenter provided supporting published literature on this topic (Duniway et al. 2018, entire; Belnap and Eldridge 2001, entire).

Response (9): We recognize the function of BSCs to promote soil stability and nutrient cycling, and we considered the published literature provided by the commenter. We agree with the commenter that BSCs may be difficult to detect; the best available information within Colorado hookless cactus' range identifies the amount of bare ground and native and invasive plant cover and no information on BSCs. The commenter does not provide additional information on BSCs' impact to Colorado hookless cactus, and we have no information to indicate that BSCs, or the lack thereof, are having lasting population-level effects for the two species. We evaluated the effects of stressors that impact BSCs, such as livestock grazing or invasive species, as part of the habitat condition index metric in our SSA report. We evaluated water availability during the growing season with a water deficit metric. These two metrics provide two of the four scores in the current and future resiliency evaluation.

Comment (10): One commenter considered our cumulative effects evaluation to be inadequate because we determined that predation, herbicides, pesticides, and collection and commercial trade were not AU- or species-level threats, and thus were not addressed in the current or future resiliency analysis.

Response (10): While some of these threats to the species were identified in the initial 1979 listing rule or may be threats at a localized level, all of them are known to impact only individual plants and are less of a concern than originally suggested. Only threats that had the potential now or in the future to have AU- or species-level effects to either species were included in the resiliency analysis. The threats mentioned by the commenter are limited in magnitude such that they will not cause a measurable impact to either cactus species currently or in the future. More information on these stressors and how we considered them can be found in section 4.1 of the SSA report (Service 2025, pp. 16-19).

Comment (11): One commenter stated that we did not mention that Colorado OHV registrations have increased dramatically since 2000, which would lead to an increase in OHV use in the species' habitat. The commenter also stated that we did not evaluate the many possible indirect impacts of OHV use to Colorado hookless cactus. Further, the commenter stated that the exclusion of non-motorized recreation (mountain bikes, hiking, camping, etc.) as a stressor is backed with no direct evidence and may be criticized because the likelihood for these activities would coincide with OHV recreation.

Response (11): The purpose of the SSA is to gather and compile information on the status of these species to assess their current condition and project the species' future condition. The commenter did not provide information on how OHV use has changed in the species' range. Moreover, the commenter did not specify or provide information regarding any other possible indirect impacts of OHV use to the species that we did not evaluate. We evaluated the effects of OHV use that include plant loss or damage; soil compaction; and increased erosion, sedimentation, and dust in the SSA report (Service 2025, pp. 17-18). As we stated in our response to a peer reviewer ( Comment 2 ) in the proposed rule (88 FR 21582 at 21584, April 11, 2023), we did not include non-motorized recreation (mountain bikes, hiking, camping, etc.) in our resiliency evaluation due to the relatively small footprint and localized impacts of these activities, BLM's general avoidance of Colorado hookless cactus when designing non-motorized trail routes, and the lack of species- or AU-level effects.

Comment (12): One commenter stated that our assertion in the proposed rule that collection is not causing population- or species-level effects to Colorado hookless cactus is counter to the species' final listing rule and justification for not designating critical habitat. The commenter claims that we are being arbitrary and capricious with respect to the threat of collection when we know the species is “highly desirable.”

Response (12): We disagree with the commenter's claim that we were arbitrary and capricious in regard to our evaluation of the threat of collection for Colorado hookless cactus. As we stated in our response to a peer reviewer ( Comment 8 ) in the proposed rule (88 FR 21582 at 21585, April 11, 2023), the best available information indicates that collection has not occurred at the level anticipated at the time of listing and is not having population- or species-level effects on either species (Krening and Dawson 2020, p. 36). Furthermore, given the taxonomic splits since listing between the two Utah Sclerocactus species and Colorado's S. glaucus and S. dawsoniae, the species mentioned in the final listing rule (44 FR 58868, October 11, 1979) as prized by cactus collectors for its beautiful purplish-red flowers is now known to be Uinta Basin hookless cactus ( Sclerocactus wetlandicus ), not S. glaucus or S. dawsoniae. Finally, the Convention on International Trade in Endangered Species (CITES) is a regulatory mechanism that helps to prevent and enforce against the illegal collection and trade of protected species, including Colorado hookless cactus. CITES protections apply to all members of the cactus family ( Cactaceae ), and as such, S. glaucus or S. dawsoniae will receive protections after delisting under the Act (see Conservation Efforts and Regulatory Mechanisms ).

Comment (13): One commenter stated that we did not demonstrate how conservation measures to protect Colorado hookless cactus would continue to be enforced and be effective post-delisting in the BLM National Conservation Areas (NCAs), Areas of Critical Environmental Concern (ACECs), and Wilderness Study Areas (WSAs).

Response (13): Protections for Colorado hookless cactus will remain in NCAs, ACECs, and WSAs regardless of its Federal listing status. These areas represent approximately 30 percent of the land in S. glaucus AUs and 41 percent of the land in S. dawsoniae AUs (see Conservation Efforts and Regulatory Mechanisms ). Species-specific protections are afforded to Colorado hookless cactus in BLM's current Dominguez-Escalante NCA resource management plan (RMP), and 8 of 11 ACECs across the range of the species specifically reference the protection of Colorado hookless cactus as a foundational goal. Likewise, NCAs, ACECs, Wilderness Areas, and WSAs are designed to protect multiple resources, not only the Colorado hookless cactus. The 1964 Wilderness Act (Pub. L. 88-577) and the Federal Land Policy and Management Act (FLPMA; 43 U.S.C. 1782) afford protections to wilderness areas and WSAs and do not allow for permanent disturbances. BLM manages these areas and will also manage for Colorado hookless cactus as a BLM sensitive species, affording both species protections.

Comment (14): Several commenters stated that the draft PDM plan's reliance on 17 macroplots provides insufficient monitoring of the two species and new or increasing site-specific stressors within their ranges. The commenters recommended that the PDM plan include rangewide monitoring of site-specific stressors across the two species' range, and that monitoring should begin prior to delisting.

Response (14): The PDM plan relies on the sampling protocols used in Krening et al. (2021a, entire), which are sufficient to detect rangewide trends for both species (see Comment (2)). We also consider the PDM sufficient to detect new or increasing stressors within the two species' ranges because BLM will provide information on newly approved, permitted, or implemented projects and impacts to Colorado hookless cactus on an annual basis (Service 2024, pp. 13-15). While the final PDM plan does not identify a specific mechanism to intervene following stressor impacts, it identifies actions that may be taken should monitoring indicate a substantial decline in the Colorado hookless cactus' density or distribution. These actions include meeting with conservation partners, extending the monitoring period, modifying monitoring practices, initiating a rangewide status assessment, or relisting Colorado hookless cactus, if warranted. During the PDM monitoring period, we will continue to work with our conservation partners to develop and implement an effective PDM plan for Colorado hookless cactus that includes an appropriate duration to detect trends, identifies potential and increasing stressors, and evaluates the impact of stressors. The monitoring identified in the PDM plan began before work began on this rulemaking action, starting in 2011 by BLM and in 2007 by the Denver Botanic Gardens (Krening et al. 2021b, p. 4; DePrenger-Levin and Hufft 2021, pp. 3-5; Service 2024, entire).

Comment (15): Two commenters were concerned that we relied on an unpublished genetic study (McGlaughlin and Naibauer 2021, entire) to inform the proposed delisting rule and noted that the genetic results have not been recognized by NatureServe.

Response (15): Since the publication of the proposed listing rule, the authors of the genetic study published their results in a peer-reviewed journal in December 2023 (McGlaughlin and Naibauer 2023, entire) and published the official species description for S. dawsoniae in 2024 (McGlaughlin and Naibauer 2024, entire). Because of the recency of this taxonomic split, there may be a delay in recognizing the Colorado hookless cactus ( S. glaucus) and Dawson's hookless cactus ( S. dawsoniae ), on websites such as NatureServe ( https://explorer.natureserve.org ) and the Integrated Taxonomic Information System ( https://www.usgs.gov/tools/integrated-taxonomic-information-system-itis ). However, the information we relied upon in drafting this rulemaking action still constitutes the best available scientific information on these species' taxonomy.

Comment (16): One commenter stated that we should not have confidence in BLM's ability to prevent livestock grazing from harming the Colorado hookless cactus because BLM has a long history of ignoring illegal grazing as identified in a 2016 U.S. Government Accountability Office (GAO) report.

Response (16): We have no information that illegal grazing is occurring in the Colorado hookless cactus' range (Lincoln 2025, pers. comm). The 2016 GAO report identifies 38 incidences of non-compliances in the State of Colorado, but the report does not identify the locations where unauthorized grazing is occurring. Therefore, we did not include this information in our SSA report. BLM's management plans allow it to include obligatory stipulations in its grazing permit renewals that require reductions in the number of livestock and adjustments to the timing, duration, and season of livestock use for the benefit of natural resources (see Livestock Grazing, below). BLM will address impacts to Colorado hookless cactus from a variety of stressors, including livestock grazing, with additional monitoring and management interventions, as identified in the PDM plan (Service 2024, entire).

A thorough review of the taxonomy, life history, and ecology of the Colorado hookless cactus ( S. glaucus and S. dawsoniae ) is presented in the SSA Report Version 1.2 (Service 2025, entire). Colorado hookless cactus has undergone a series of taxonomic revisions since its original 1979 listing. When listed, the range of Sclerocactus glaucus was considered to include western Colorado and northeastern Utah (Uinta Basin hookless cactus complex). A reevaluation of morphological characteristics, phylogenetic studies, and common garden experiments led to the determination that the Uinta Basin hookless cactus complex was in fact three distinct species: Sclerocactus glaucus (Colorado hookless cactus), Sclerocactus brevispinus (Pariette cactus), and Sclerocactus wetlandicus (Uinta Basin hookless cactus) (Heil and Porter 2004, pp. 197-207; Hochstätter 1993, pp. 82-92). Sclerocactus glaucus was determined to be restricted to the Colorado and Gunnison River basins in western Colorado, while Sclerocactus brevispinus and Sclerocactus wetlandicus are limited to the Uinta Basin in eastern Utah. In 2009, the Service published a final rule recognizing and accepting this revised taxonomy of the three species and determined that all three species would continue to be listed as threatened (74 FR 47112, September 15, 2009). Most recently, in 2017, genetic studies identified three distinct regional groups of Colorado hookless cactus in Colorado: the northern, Grand Valley, and Gunnison River groups (Schwabe et al. 2015, p. 447; McGlaughlin and Ramp-Neale 2017, p. 5). The most recent genetic analyses, using Random Site-Associated DNA sequencing, determined that the northern group should be recognized as a distinct species, hereinafter Sclerocactus dawsoniae, or S. dawsoniae (McGlaughlin and Naibauer 2023, p. 5). The Grand Valley and Gunnison River groups share connectivity and form a genetically cohesive group, which represents a second distinct species, hereinafter collectively referred to as Sclerocactus glaucus, or S. glaucus (McGlaughlin and Naibauer 2023, p. 5). Because of the recency of this taxonomic split, the currently listed entity is still considered to be the Colorado hookless cactus, which encompasses both S. glaucus and S. dawsoniae; thus, both Sclerocactus glaucus and Sclerocactus dawsoniae are the subjects of our SSA report and this final delisting rule.

Given the recent nature of this new taxonomic information, most literature on the species draws conclusions regarding both S. glaucus and S. dawsoniae without distinguishing between the two. Thus, when we use the common name “Colorado hookless cactus” in this final rule, we are referring to information or conclusions regarding both species ( S. glaucus and S. dawsoniae ). When we are referring to information or analysis pertaining to one species, we will use the new scientific names of S. glaucus or S. dawsoniae.

S. glaucus and S. dawsoniae are endemic cactus species found in the Colorado and Gunnison River basins and their tributary canyons in Garfield, Mesa, Montrose, and Delta Counties in western Colorado. The species occur on alluvial benches and colluvial slopes from 1,372 to 2,195 m (4,500 to 7,200 ft) in semi-arid high-elevation desert (Holsinger 2021, pers. comm.; Service 2025, p. 9). The species display a patchy, generalist distribution and have been found to grow primarily in small, discrete colonies of individuals in various upland desert habitats and communities (Krening and Dawson 2020, p. 18; Service 2025, p. 9).

For the purposes of analysis in our SSA report, we divided the ranges of S. glaucus and S. dawsoniae into analysis units (AUs). S. glaucus occurs in eight AUs in a range that extends approximately 2,802 square kilometers (km 2 ) (1,082 square miles (mi 2 )) from the Grand Valley, through the high desert at the foot of the Grand Mesa, and along the alluvial terraces of the Gunnison River and the Dominguez and Escalante Creek drainages to near Montrose. S. dawsoniae occurs over an area of approximately 505 km 2 (195 mi 2 ) in two AUs along the Colorado River from DeBeque downstream toward the Grand Valley and along the Roan and Plateau Creek drainages. BLM owns and manages approximately 72 percent and 68 percent, respectively, of the land that comprises the S. glaucus and S. dawsoniae AUs (Service 2025, pp. 19-22).

S. glaucus and S. dawsoniae are morphologically indistinguishable from each other and can be identified from one another only by genetic analysis or location. They are both leafless, flowering, stem-succulent plants with short, cylindrical bodies usually 3 to 12 centimeters (cm) (1.2 to 4.8 inches (in)) but up to 30 cm (12 in) tall and 4 to 9 cm (1.6 to 3.6 in) in diameter (Service 2025, pp. 7-8). The brown coloring of the spines on mature plants is unique to S. glaucus, S. dawsoniae, and S. parviflorus, as compared to other cactus species in the area (Service 2025, p. 7).

Colorado hookless cactus has three life stages: seeds, seedlings, and mature reproductive adults. Colorado hookless cactus plants are considered hardy, long-lived perennial species ( i.e., high survival probabilities and low levels of recruitment) (BLM 2018, p. 15). Based on high observed seedling survival, once a seedling is established, there is a high probability of an individual persisting to reproductive stage (BLM 2018, p. 14; Service 2025, p. 13). Pollinator-assisted outcrossing (xenogamy) is the primary mode of genetic exchange for the Colorado hookless cactus (Janeba 2009, p. 67; Tepedino et al. 2010, p. 382; Service 2025, p. 8). Plants usually flower in late April and early May. Plants do not flower until they reach a diameter of more than 4 cm (1.6 in) (BLM 2018, p. 14); plants are likely at least 4 to 6 years old before they become reproductive and continue to flower throughout their relatively long life (DePrenger-Levin 2021, pers. comm.; Service 2025, p. 13). Colorado hookless cactus can live for many years, but their exact longevity is unknown.

Section 4(f) of the Act directs us to develop and implement recovery plans for the conservation and survival of endangered and threatened species unless we determine that such a plan will not promote the conservation of the species. Under section 4(f)(1)(B)(ii), recovery plans must, to the maximum extent practicable, include objective, measurable criteria which, when met, would result in a determination, in accordance with the provisions of section 4 of the Act, that the species be removed from the Lists of Endangered and Threatened Wildlife and Plants.

Recovery plans provide a roadmap for us and our partners on methods of enhancing conservation and minimizing threats to listed species, as well as measurable criteria against which to evaluate progress towards recovery and assess the species' likely future condition. However, they are not regulatory documents and do not substitute for the determinations and promulgation of regulations required under section 4(a)(1) of the Act. A decision to revise the status of a species or to delist a species is ultimately based on an analysis of the best scientific and commercial data available to determine whether a species is no longer an endangered species or a threatened species, regardless of whether that information differs from the recovery plan.

There are many paths to accomplishing recovery of a species, and recovery may be achieved without all of the criteria in a recovery plan being fully met. For example, one or more criteria may be exceeded while other criteria may not yet be accomplished. In that instance, we may determine that the threats are minimized sufficiently and that the species is robust enough that it no longer meets the definition of an endangered species or a threatened species. In other cases, we may discover new recovery opportunities after having finalized the recovery plan. Parties seeking to conserve the species may use these opportunities instead of methods identified in the recovery plan. Likewise, we may learn new information about the species after we finalize the recovery plan. The new information may change the extent to which existing criteria are appropriate for identifying recovery of the species. The recovery of a species is a dynamic process requiring adaptive management that may, or may not, follow all of the guidance provided in a recovery plan.

A recovery plan for Colorado hookless cactus was not prepared due to lack of staff capacity; therefore, specific delisting criteria were not developed for the species. However, we developed a recovery outline for Colorado hookless cactus in 2010 (Service 2010, entire). A recovery outline is a succinct document that presents a preliminary recovery strategy and actions to direct recovery efforts for a newly listed species until a recovery plan is completed. Additionally, we reviewed the status of the species in the 2008 and 2021 5-year status reviews (Service 2008, entire; Service 2021, entire). In the 2008 review, we identified remaining threats to the species and actions that could be taken to make progress in addressing those threats and ensuring long-term management. One such recommendation was to conduct rangewide inventories and improve population monitoring (Service 2008, p. 4). Denver Botanic Gardens and BLM have closely monitored Colorado hookless cactus at multiple sites throughout its range since 2007 (DePrenger-Levin and Hufft 2021, entire; Krening et al. 2021b, entire). Based on over a decade of this rich monitoring data, BLM developed a method of estimating population size and trends in 2021 for S. glaucus (Krening et al. 2021a, entire) and in 2023 for S. dawsoniae (Krening and Holsinger 2024, entire), representing the best available scientific and commercial information for the species regarding total population size (Krening et al. 2021a, entire; Krening and Holsinger 2024, entire).

The 2010 recovery outline also included an initial action plan for the species' recovery that included actions such as (1) expanding comprehensive surveying to improve our understanding of trends; (2) establishing formal land management designations to provide for long-term protection of important populations and habitat; (3) directing development projects to avoid cactus occurrences and incorporate standard conservation measures; (4) encouraging investigations into Sclerocactus species' vulnerability to climate change; and (5) resolving open taxonomic questions for the species. The Service and its partners have since accomplished all five of these actions.

Since 2010, BLM and the Denver Botanic Gardens have expanded their annual monitoring program to assess demographic trends and improve estimation of the species' population sizes; these estimates indicate there are substantially more Colorado hookless cactus plants on the landscape than were known at the time of listing and have changed our understanding of the degree to which the species are resilient to the threats apparent at the time of listing. As stated previously, BLM has also established multiple ACECs and an NCA that provide long-term protection to BLM sensitive plants and habitats. In the past 11 years, multiple assessments of the species' vulnerability to climate change have concluded that Colorado hookless cactus has low vulnerability to future climatic changes (Price 2018, appendix 3 of Krening and Dawson 2020, p. 60; Still et al. 2015, p. 116; Treher et al 2012, pp. 8, 52). Finally, as discussed at length above in this document, recent genetic research has determined that Colorado hookless cactus is in fact two separate species: S. glaucus and S. dawsoniae, thus resolving an open taxonomic question for the species, as identified by the recovery outline.

Section 4 of the Act (16 U.S.C. 1533) and the implementing regulations in title 50 of the Code of Federal Regulations set forth the procedures for determining whether a species is an endangered species or a threatened species, issuing protective regulations for threatened species, and designating critical habitat for endangered and threatened species. On April 5, 2024, jointly with the National Marine Fisheries Service, the Service issued a final rule that revised the regulations in 50 CFR part 424 regarding how we add, remove, and reclassify endangered and threatened species and what criteria we apply when designating listed species' critical habitat (89 FR 23919). That final rule is now in effect and is incorporated into the current regulations. Our analysis for this decision applied our current regulations. Given that we proposed delisting this species under our prior regulations (revised in 2019), we have also undertaken an analysis of whether the decision would be different if we had continued to apply the 2019 regulations and we concluded that the decision would be the same. The analyses under both the regulations currently in effect and the 2019 regulations are available on https://www.regulations.gov.

The Act defines an “endangered species” as a species that is in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act requires that we determine whether any species is an endangered species or a threatened species because of any of the following factors:

(A) The present or threatened destruction, modification, or curtailment of its habitat or range;

(B) Overutilization for commercial, recreational, scientific, or educational purposes;

(C) Disease or predation;

(D) The inadequacy of existing regulatory mechanisms; or

(E) Other natural or manmade factors affecting its continued existence.

These factors represent broad categories of natural or human-caused actions or conditions that could have an effect on a species' continued existence. In evaluating these actions and conditions, we look for those that may have a negative effect on individuals of the species, as well as other actions or conditions that may ameliorate any negative effects or may have positive effects. The determination to delist a species must be based on an analysis of the same five factors.

We use the term “threat” to refer in general to actions or conditions that are known to or are reasonably likely to negatively affect individuals of a species. The term “threat” includes actions or conditions that have a direct impact on individuals (direct impacts), as well as those that affect individuals through alteration of their habitat or required resources (stressors). The term “threat” may encompass—either together or separately—the source of the action or condition or the action or condition itself.

However, the mere identification of any threat(s) does not necessarily mean that the species meets the statutory definition of an “endangered species” or a “threatened species.” In determining whether a species meets either definition, we must evaluate all identified threats by considering the species' expected response and the effects of the threats—in light of those actions and conditions that will ameliorate the threats—on an individual, population, and species level. We evaluate each threat and its expected effects on the species, then analyze the cumulative effect of all of the threats on the species as a whole. We also consider the cumulative effect of the threats in light of those actions and conditions that will have positive effects on the species—such as any existing regulatory mechanisms or conservation efforts. The Secretary determines whether the species meets the definition of an “endangered species” or a “threatened species” only after conducting this cumulative analysis and describing the expected effect on the species.

The Act does not define the term “foreseeable future,” which appears in the statutory definition of “threatened species.” Our implementing regulations at 50 CFR 424.11(d) set forth a framework for evaluating the foreseeable future on a case-by-case basis, which is further described in the 2009 Memorandum Opinion on the foreseeable future from the Department of the Interior, Office of the Solicitor (M-37021, January 16, 2009; “M-Opinion,” available online at https://www.doi.gov/sites/doi.opengov.ibmcloud.com/files/uploads/M-37021.pdf ). The foreseeable future extends as far into the future as the U.S. Fish and Wildlife Service and National Marine Fisheries Service (hereafter, the Services) can make reasonably reliable predictions about the threats to the species and the species' responses to those threats. We need not identify the foreseeable future in terms of a specific period of time. We will describe the foreseeable future on a case-by-case basis, using the best available data and taking into account considerations such as the species' life-history characteristics, threat-projection timeframes, and environmental variability. In other words, the foreseeable future is the period of time over which we can make reasonably reliable predictions. “Reliable” does not mean “certain”; it means sufficient to provide a reasonable degree of confidence in the prediction, in light of the conservation purposes of the Act.

The SSA report documents the results of our comprehensive biological review of the best scientific and commercial data regarding the status of the species, including an assessment of the potential threats to the species. The SSA report does not represent our decision on whether the species should be delisted. However, it does provide the scientific basis that informs our regulatory decisions, which involve the further application of standards within the Act and its implementing regulations and policies. To assess Colorado hookless cactus' viability, we used the three conservation biology principles of resiliency, redundancy, and representation (Shaffer and Stein 2000, pp. 306-310). Briefly, resiliency is the ability of the species to withstand environmental and demographic stochasticity (for example, wet or dry, warm or cold years); redundancy is the ability of the species to withstand catastrophic events (for example, droughts, large pollution events), and representation is the ability of the species to adapt to both near-term and long-term changes in its physical and biological environment (for example, climate conditions, pathogens). In general, species viability will increase with increases in resiliency, redundancy, and representation (Smith et al. 2018, p. 306). Using these principles, we identified the species' ecological requirements for survival and reproduction at the individual, population, and species levels, and described the beneficial and risk factors influencing the species' viability.

The SSA process can be categorized into three sequential stages. During the first stage, we evaluated individual species' life-history needs. The next stage involved an assessment of the historical and current condition of the species' demographics and habitat characteristics, including an explanation of how the species arrived at its current condition. The final stage of the SSA involved making predictions about the species' responses to positive and negative environmental and anthropogenic influences. Throughout all of these stages, we used the best available information to characterize viability as the ability of a species to sustain populations in the wild over time, which we then used to inform our regulatory decision.

The following is a summary of the key results and conclusions from the SSA report; the full SSA report can be found at Docket FWS-R6-ES-2022-0093 on https://www.regulations.gov.

In this discussion, we review the biological condition of the species and its resources, and the threats that influence the species' current and future condition, in order to assess the species' overall viability and the risks to that viability. In addition, the SSA report (Service 2025, entire) documents our comprehensive biological status review for the species, including an assessment of the potential threats to the species.

The following is a summary of this status review and the best available information gathered since that time that has informed this decision.

Individuals of both species of Colorado hookless cactus need certain habitat factors, including shallow exposed sandy or shale soils of sedimentary parent material or gravelly deposits of river alluvium; a semi-arid, high-elevation desert climate (elevations from 1,200-2,000 m (3,937-6,561 ft) with 20-30 cm (8-12 in) of rain per year; and a period of deep cold during winter months to facilitate germination the following spring (Service 2025, pp. 8, 11-12). To be sufficiently resilient, populations, referred to as analytical units (AUs) of both species require survivorship and recruitment at rates that are able to sustain AUs, in addition to pollinator connectivity between individuals and clusters of plants within the AU. Adequately resilient AUs also contain enough individuals across each life stage (seed, seedling, and mature reproductive adult) to bounce back after experiencing environmental stressors such as intermediate disturbance, occasional drought, or intensive grazing.

The number of AUs across the landscape influence redundancy of Colorado hookless cactus. AUs, synonymous with populations, include many cactus individuals and were delineated by natural geological and ecological features and management boundaries within each species' range (Service 2025, pp. 6-8). More AUs across the range of each species increase each species' ability to withstand catastrophic events. Individuals and AUs inhabiting diverse ecological settings and exhibiting genetic or phenological variation add to the level of representation across the species' ranges. The greater diversity observed in genetics, habitats, and morphology, the more likely Colorado hookless cactus is to be able to adapt to change over time. Thus, both species need (1) a sufficient number and distribution of sufficiently resilient AUs to withstand catastrophic events (redundancy) and (2) a range of genetic, morphologic, and habitat variation that allows the species to adapt to changing environmental conditions (representation) (Service 2025, pp. 15-16). The SSA report provides additional detail on the species' individual-, population-, and species-level needs (Service 2025, pp. 10-16).

In our SSA, we evaluated stressors and other actions that can positively or negatively affect Colorado hookless cactus at the individual, AU (population), or species levels, either currently or into the future (Service 2025, pp. 16-19). A wide variety of stressors may influence the resiliency of Colorado hookless cactus, either by directly affecting individuals or by reducing the quality and quantity of habitats.

Stressors that have the potential to present AU-level effects for both species include livestock use, invasive species, oil and gas development, OHV recreational use, development and maintenance of utility corridors, and the effects of global climate change (Krening and Dawson 2020, p. 30; Service 2025, pp. 16-19). We determined that oil shale deposit development and gold mining, predation, herbicide and pesticide application, or collection and commercial trade are not threats to the existence of the species (even though they were identified as such in the 1979 listing rule), so we do not discuss them in detail in this rule (Service 2025, pp. 16-19).

Additionally, approximately 30 percent of the land in S. glaucus AUs and 41 percent of the land in S. dawsoniae AUs have special BLM land management designations in the form of NCAs, ACECs, a WSA, and a Wilderness Area. These designations limit or exclude the authorization of certain land uses, and some designations were specifically created for the conservation of natural resources. The protections provided by these management designations are not contingent upon the species' federally listed status, and these designations help to facilitate the maintenance and recovery of cactus occurrences because they are areas where Colorado hookless cactus is not likely to be disturbed or adversely altered by land-use actions (Krening and Dawson 2020, p. 26). Eight of 11 ACECs specifically reference the protection of Colorado hookless cactus as a foundational goal. We discuss the specific protections each of these areas provides, and the ways in which they reduce specific stressors, under the relevant stressors below; we also discuss these conservation measures further under Conservation Efforts and Regulatory Mechanisms. While the majority of the remaining habitat is on private lands, approximately 28 percent for S. glaucus and 32 percent for S. dawsoniae, we do not have reliable information for Colorado hookless cactus on private lands. Since the private lands are interspersed with BLM lands, we assume that the stressors are the same on BLM and private lands (Service 2025, pp. 20-22).

BLM owns and manages approximately 72 percent and 68 percent, respectively, of the land that comprises S. glaucus and S. dawsoniae AUs (Service 2025, pp. 19-22). While approximately 5 percent of this habitat excludes or manages for livestock use for the purposes of minimizing impacts to Colorado hookless cactus, nearly all habitat that occurs on BLM lands allows for livestock use. Moderate to heavy domestic livestock grazing has been observed to cause physical damage to Sclerocactus plants through trampling; however, on rare occasions do cattle directly trample or dislodge cactus plants (Service 1990, p. 11). We have no information to indicate that cattle browse on individual Sclerocactus plants since their spines generally make them undesirable livestock forage (Dawson 2025, entire; Hornbeck 2025, entire). A study on another federally listed cactus, S. wrightiae, found that cacti density increased more rapidly in a fenced plot excluded from cattle grazing than in an unfenced plot with a reduced cattle stocking rate (Clark and Clark 2007, p. 21). Overgrazing (the continued heavy grazing beyond the recovery capacity of forage plants) by domestic livestock can have a negative impact on North American xeric (very dry and low humidity) ecosystems (Jones 2000, p. 158). For example, overgrazing can facilitate the establishment of invasive species like Bromus tectorum, known as cheatgrass (Masters and Sheley 2001, p. 503; DiTomaso et al. 2016, p. 435), which are difficult to eradicate and tend to outcompete native vegetation, including cacti.

Currently, BLM manages livestock activities to protect sensitive plants in the Adobe Badlands, River Rims, and Escalante Canyon ACECs (BLM 2017, p. 240, p. 258; Krening and Dawson 2020, p. 28; Service 2025, pp. 19-22). In the Atwell Gulch ACEC, BLM excludes livestock grazing entirely on 2,600 ac (1,052 ha), and in the Pyramid Rock ACEC, no livestock grazing is allowed (Krening and Dawson 2020, p. 29; Service 2025, pp. 20-22). BLM monitoring indicates that livestock are not present in these protected areas (Krening and DePrenger-Levin 2023, entire). BLM's management plans allow it to include obligatory stipulations in its grazing permit renewals that require reductions in the number of livestock and adjustments to the timing, duration, and season of livestock use for the benefit of natural resources; such changes in grazing permits would primarily affect future grazing intensity in the Cactus Park ( S. glaucus ), Devil's Thumb ( S. glaucus ), Gunnison River East ( S. glaucus ), Roan Creek ( S. dawsoniae ), and Plateau Creek AUs ( S. dawsoniae ).

Currently, livestock use is affecting individual plants in localized areas and is not resulting in population-level effects based on stable or increasing population-level trends (Service 2025, pp. 18-19; Krening and DePrenger-Levin 2023, entire); however, these effects could increase in the future if no corrective action is taken to address future problem areas. Thus, we included an analysis in the SSA to examine the species' potential response to future changes and increases to this stressor (Service 2025, pp. 28-36).

Invasive weeds, including Bromus tectorum (cheatgrass) and Halogeton glomeratus (halogeton), are prevalent on BLM and private lands within the range of Colorado hookless cactus (Krening and Dawson 2020, p. 35). Invasive weeds alter the ecological characteristics of cactus habitat, making it less suitable for the species (Service 1990, p. 11). In addition, invasive annual weeds are often able to outcompete perennial native species for the essential nutrient nitrogen under drought conditions (Everard et al. 2010, pp. 85, 93-94). However, despite their prevalence throughout the range of Colorado hookless cactus species, individual plants experience extreme detrimental effects of invasive weeds only in localized areas (Service 2025, pp. 16-22; Krening and DawsonBLM 2020, p. 35).

Currently, invasive vegetation affects only individual Colorado hookless cactus plants; invasive species are not causing any broad-scale reductions in recruitment or survival in entire AUs. However, the effects of invasive vegetation could increase in the future if infestations expand or if treatments become less effective. Thus, we included an analysis in the SSA to examine the species' potential response to future changes and increases to this stressor (Service 2025, pp. 16-22, 28-36).

Oil and gas development can also affect Colorado hookless cactus plants and habitat. Increased surface disturbance from wells, roads, and pipelines for oil and gas projects can fragment or destroy habitat; disturb individuals; increase erosion, soil compaction, and sedimentation; destroy pollinator habitat; increase airborne dust and subsequent dust accumulation on cacti, which can increase tissue temperature and reduce photosynthesis, thus decreasing plant growth, vigor, and water use efficiency; indirectly increase recreational access to habitat through increased road construction; and increase invasive vegetation because of the associated surface disturbances (Service 2010, pp. 6-7).

For S. glaucus, only 5 percent of the AUs (19,365 ac (7,837 ha) of 379,348 total ac (153,517 ha) of habitat) are within BLM lands leased for oil and gas (BLM 2021, unpaginated). This proportion is higher for S. dawsoniae; 58 percent of the area within AUs are leased for oil and gas development on BLM lands (65,384 ac (26,419 ha) of 112,723 total ac (45,617 ha) of habitat) (BLM 2021, unpaginated). However, leased areas do not equate to areas of surface disturbance; even if these areas are leased for oil and gas development, only small subsets of these areas are actually being actively explored or extracted (Colorado Oil and Gas Conservation Commission (COGCC) 2022a, unpaginated). Moreover, oil and gas development does not occur throughout all of the species' ranges; for S. glaucus, active wells are only in the Devil's Thumb AU (one active well site), North Fruita Desert AU (10 active well sites), Whitewater AU (26 active well sites), and a very small portion of the Palisade AU (one active well site) (COGCC 2022b, unpaginated). For S. dawsoniae, while oil and gas development occurs in both AUs (Roan Creek (60 active well sites) and Plateau Creek (51 active well sites)), 42 percent of these AUs are not leased for oil and gas development (COGCC 2022b, unpaginated; BLM 2021, unpaginated). Additionally, there are no new or pending permits to drill new oil and gas wells within either species' range; however, as we describe in more detail below, development could increase within portions of S. dawsoniae' s range in the future (COGCC 2022c, unpaginated; COGCC 2022d, unpaginated).

Additionally, BLM's resource planning documents include conservation measures to minimize adverse impacts of natural resource extraction to listed and sensitive species, including the Colorado hookless cactus; these measures include limiting oil and gas development within a 100-m (328-ft) buffer around any currently occupied or historically occupied Colorado hookless cactus habitat, when possible and with some exceptions (Krening and Dawson 2020, p. 34; BLM 2015a, p. B-13; BLM 2015b, p. B-22; BLM 2020, p. B-9). While these limitations and buffers are not obligatory, BLM applies them, with certain exceptions, to BLM sensitive species, which S. glaucus and S. dawsoniae will become once Colorado hookless cactus is removed from the List of Endangered and Threatened Plants (see Conservation Efforts and Regulatory Mechanisms ). Even without the protections given to BLM sensitive species, based on our analysis of Colorado Oil and Gas Conservation Commission (COGCC) data, current oil and gas extraction is relatively limited throughout the range of both species compared to the amount of occupied habitat (COGCC 2022a, unpaginated; COGCC 2022b, unpaginated; COGCC 2022c, unpaginated; COGCC 2022d, unpaginated). Moreover, due to their biology and life history characteristics, both species are relatively resilient to nearby disturbance (as we discuss further in our analysis of Current Condition below).

Furthermore, approximately 30 percent of the land in S. glaucus AUs and 41 percent of the land in S. dawsoniae AUs have special BLM land management designations in the form of NCAs, ACECs, a WSA, and a Wilderness Area, which further protect the species from the impacts of oil and gas development (Service 2025, pp. 16-22). The protections provided by these management designations are not contingent upon the species' federally listed status, and these designations help to facilitate the maintenance and recovery of cactus occurrences because they are areas where neither the Colorado hookless cactus is likely to be disturbed nor will its habitat be adversely altered by land-use actions (Krening and Dawson 2020, p. 26). All 30 percent of the areas within S. glaucus AUs that have special land management designations include stipulations that either withdraw lands from oil, gas, and mineral development, implement “no-surface-occupancy” stipulations, or prohibit surface-disturbing activities (Service 2025, pp. 19-22). Therefore, no new oil and gas activity is permitted in almost 30 percent of S. glaucus' s range (with the exception of portions of the Devil's Thumb AU); these areas where no new oil and gas activity is permitted coincide with over half (over 56 percent) of the estimated S. glaucus occurrences (Service 2025, pp. 14, 21-22). Similarly, all 41 percent of the areas within S. dawsoniae AUs that have special land management designations include no-surface-occupancy stipulations that limit oil and gas development in these portions of the species' range.

Thus, currently, oil and gas development is affecting only a small proportion of individual Colorado hookless cactus plants, due to limited leasing and development and BLM's protective measures; however, the effects of oil and gas development could increase in the future. Nevertheless, given the variable oil and gas potential (none, low, medium, and high potential) of the area, and the protections outlined above, the only AUs where oil and gas development could plausibly increase in the future are the Roan Creek and Plateau Creek AUs ( S. dawsoniae ) with high oil and gas potential (BLM 2024, entire; Service 2025, p. 30). Thus, we included an analysis in the SSA to examine the species' potential response to future changes in this stressor (Service 2025, pp. 28-36).

Off-highway vehicle (OHV) use can cause soil compaction and erosion, which can physically damage habitat, the surrounding plant community, and the hydrology of the area. OHVs can also carry invasive and introduced plants to new sites and present a risk of spilled contaminants, such as oil spills, gasoline, and grease. OHV use can also injure or kill above-ground plants or cause direct harm to plants through accumulation of dust. OHV use can create especially negative impacts when users travel off designated routes (Service 2025, pp. 16-19).

The relatively barren nature and other topographical features of Colorado hookless cactus habitat make it desirable to OHV users (Krening and Dawson 2020, p. 38). Even though OHV recreation is popular and widespread within Colorado hookless cactus habitat, there is little evidence of direct negative impacts to plants (Service 2010, p. 8; Krening and Dawson 2020, p. 38).

BLM's resource planning documents include conservation measures to minimize adverse impacts of land use to listed and sensitive species, including the Colorado hookless cactus (BLM 2015a, pp. 49, 102-105; BLM 2015b, pp. 26, 101-103, 123, 145, 147, 150; BLM 2015c, p. M-25; BLM 2020, pp. II-87, I-4-I-10). In their Travel Management Plans for the Grand Junction and Uncompahgre Field Offices, BLM identified multiple routes for closure to protect sensitive areas (BLM 2015c, p. M-24; BLM 2020, p. I-7). These two travel management plans cover the entirety of S. glaucus' s range and the majority of S. dawsoniae' s range. While the resource management plan for the Colorado River Valley Field Office, which covers the remainder of S. dawsoniae' s range, does not contain a travel management plan specifically, it includes strategies for “Comprehensive Trails and Travel Management,” including limiting recreational use to designated routes (BLM 2015b, pp. 102-104). Additionally, as stated previously in this document, approximately 30 percent of the land in S. glaucus AUs and 41 percent of the land in S. dawsoniae AUs have special BLM land management designations in the form of NCAs, ACECs, a WSA, and a Wilderness Area, which further protect the species from the impacts of OHV use by limiting routes within 200 m (656 ft) of sensitive plants or prohibiting all motorized travel (Krening and Dawson 2020, pp. 27-29; Service 2025, pp. 19-22). For example, when the Dominguez-Escalante NCA was created in 2009, which covers 210,172 ac (85,053 ha) within the Dominguez-Escalante, Gunnison River East, and Cactus Park AUs, 268 miles of routes were closed to mechanized and motorized travel, which includes the use of OHVs (BLM 2017, p. 282; Krening and Dawson 2020, p. 27).

As human populations continue to grow in the areas surrounding Colorado hookless cactus, demand for OHV recreation is likely to continue to increase. However, BLM would be able to add routes only in areas outside of the aforementioned ACECs, WSA, and Wilderness Area. Any increases in designated OHV routes would occur as a result of land use planning processes that would comply with the stipulations of the FLPMA and the National Environmental Policy Act (Krening and Dawson 2020, p. 38). Given the protections detailed above, and the accessibility of certain areas to OHV users, the only AUs where OHV use could plausibly increase in the future are the North Fruita Desert, Devil's Thumb, Gunnison Gorge, and Whitewater AUs ( S. glaucus ) (Service 2025, p. 30). The area represented in these four AUs constitutes approximately half of S. glaucus' AU range, but it is unlikely that OHV use would occur across the entire area of these AUs. Through similar processes, BLM may also choose to close areas to recreation or access if necessary to protect sensitive resources (Krening and Dawson 2020, p. 38). It is plausible that implementation of travel management plans could lead to route closures in S. glaucus AUs (Devil's Thumb, Gunnison Gorge, Whitewater, Palisade, Dominguez-Escalante, North Fruita Desert) and S. dawsoniae AUs (Plateau Creek, and Roan Creek AUs).

Thus, currently, OHV use is affecting only a small proportion of individual Colorado hookless cactus plants; however, the effects of OHV use could increase in the future if recreational opportunities expand. Therefore, we included an analysis in the SSA to examine the species' potential response to future changes in this stressor (Service 2025, pp. 28-36).

The installation and maintenance of utility corridors can result in damage, loss, or relocation of plants; fragmentation of habitat; and increases in invasive species (Krening and Dawson 2020, p. 34; Service 2025, pp. 17-19). Multiple transmission lines occur within Colorado hookless cactus habitat and “approximately 1,200 plants have been transplanted in association with these projects” (Bio-Logic 2008 as cited in Krening and Dawson 2020, p. 34). While every AU has a utility corridor within it, most corridors intersect only a small portion of the AU. Additionally, some of these utility lines are along already-disturbed corridors ( e.g., major highways).

In addition to the limited scope of utility corridor development and maintenance within Colorado hookless cactus habitat, federally protected areas further limit the impacts that utility corridor development can have on the species. Six of the seven ACECs within S. glaucus' range and all four of the ACECs within S. dawsoniae' s range include right-of-way exclusion or avoidance areas (Service 2025, pp. 19-22).

Based on practical locations for utility corridors, and on these protections, it is plausible that development could increase in the energy corridor that intersects the Whitewater, Devil's Thumb, and Cactus Park AUs and along the I-70 corridor in the Palisade AU (Service 2025, p. 30). It is also plausible that developers could replace an existing powerline with a larger structure in the Devil's Thumb and Whitewater AUs to increase capacity, which could cause significant ground disturbance (Service 2025, p. 30). Finally, developers could build additional pipelines in the Roan Creek and Plateau Creek AUs (Service 2025, p. 30).

Thus, currently, development and maintenance of utility corridors are affecting only individual Colorado hookless cactus plants, partly due to BLM's avoidance and mitigation measures; however, the effects of this stressor could increase in the future if development expands. Therefore, we included an analysis in the SSA to examine the species' potential response to future changes in this stressor.

Climate change may affect long-term survival of native species, including Sclerocactus, especially if longer or more frequent droughts occur. Within the range of Colorado hookless cactus, under lower emission scenarios, summer maximum temperature is expected to increase 4 °F (2.2 °C) and under higher emission scenarios summer maximum temperature is expected to increase 10 °F (5.6 °C) by mid-century, compared to the historical average between 1971 and 2000 (North Central Climate Adaptation Science Center and CIRES 2021, unpaginated). Extreme droughts, like those that occurred in 2002 and 2018, could also become more frequent by mid-century. Historically, droughts of this scale did not occur with this frequency within the range of the species (North Central Climate Adaptation Science Center and CIRES 2021, unpaginated). By mid-century, under lower emissions scenarios, these extreme droughts could occur two to three times per decade or, under higher emissions scenarios, eight to nine times per decade (North Central Climate Adaptation Science Center and CIRES 2021, unpaginated).

In addition, invasive annual weeds are often able to outcompete perennial native species for the essential nutrient nitrogen under drought conditions (Everard et al. 2010, pp. 85, 93-94). Drought conditions could further hinder BLM's efforts to control invasive weeds and restore native vegetation, which is already difficult due to the extreme environment of the Colorado and Gunnison River basins (Service 1990, p. 11).

Climate change vulnerability analyses concluded that Colorado hookless cactus likely has low vulnerability to climate change (Krening and Dawson 2020, pp. 43-44); however, these analyses predated the taxonomic split of Colorado hookless cactus and thus analyzed the range that contains both S. glaucus and S. dawsoniae. First, NatureServe's Climate Change Vulnerability Index (CCVI), which evaluates species' vulnerability to climate change based on multiple factors, indicated that Colorado hookless cactus was “not vulnerable” or “presumed stable” rangewide, meaning the number of plants or range extent is not likely to increase or decrease considerably by mid-century (Treher et al. 2012, pp. 8, 52). Second, a combination of CCVI and species distribution modeling (SDM) methods indicated that Colorado hookless cactus “will not be vulnerable to climate change” within the next 30 years (Still et al. 2015, p. 116). This analysis predicted that the Colorado hookless cactus' range could shift or increase under projected changes in climate given the Colorado hookless cactus has no dispersal constraints and vast areas of suitable habitat beyond known occurrences (Still et al. 2015, p. 116). Finally, an additional SDM effort, which aimed to predict changes to the species' range under five different future climate scenarios, concluded that climate change does not present a threat, because all but one model indicates that either no range contraction will occur or that range extent will expand by midcentury (Price 2018, appendix 3 of Krening and Dawson 2020, p. 60).

Although multiple different models predict the Colorado hookless cactus has low vulnerability to climate change, Colorado Natural Heritage Program's (CNHP) CCVI suggested that Colorado hookless cactus is extremely vulnerable to climate change given “(1) natural and anthropogenic barriers to movement; (2) likelihood of short seed dispersal distances; (3) lack of variation in annual precipitation in occupied habitat over last 50 years; (4) potential increase in climate influenced disturbances within its habitat, (5) potential for wind and solar energy development within its range, and (6) pollinator specificity” (CNHP 2015, p. 533). Although the weight of research indicates both species likely have low vulnerability to climate change, given the uncertainty that this CNHP study introduced, we included an analysis in the SSA to examine the species' potential response to future changes in this stressor.

Positive actions, in the form of conservation efforts such as land protections and regulations, have reduced sources of habitat degradation, and multiple agencies, volunteers, and community members are committed to the conservation and preservation of Colorado hookless cactus. BLM owns and manages approximately 72 percent and 68 percent, respectively, of the land that comprises S. glaucus and S. dawsoniae AUs (Service 2025, pp. 19-22). The majority of the remaining habitat is privately owned; less than 1 percent is owned by State or local governments (Service 2025, p. 19).

Within the range of the Colorado hookless cactus, BLM has included conservation measures in its resource planning documents to minimize adverse impacts of land use to listed and BLM sensitive species, including the Colorado hookless cactus (Krening and Dawson 2020, p. 26). For example, BLM RMPs for the Colorado River Valley, Grand Junction, and Uncompahgre field offices (the three BLM field offices within the range of the species) include restrictions on surface-disturbing activities for BLM sensitive species, such as controlled surface use stipulations 100 m (328 ft) away from occupied habitat, and the ability to move a project more than 200 m (656 ft) away from occupied habitat (BLM 2015a, B-39; BLM 2015b, B-30; BLM 2020, B-21). In addition, the RMPs have motorized recreation restrictions, energy development restrictions, and grazing management; provisions for research to aid in better understanding the effects of stressors on the species and guide conservation efforts; and provisions for habitat improvements and vegetation management ( e.g., reducing encroachment of woody species, fuels management, closing of livestock allotments, or maintaining rangeland health standards) (Service 2025, pp. 19-22, 28-36; BLM 2015a, pp. 41, 68; BLM 2020, p. II-24).

Even without the protections of the Act, both species would remain BLM sensitive species for at least 10 years (BLM 2008, entire; Dawson 2023, pers. comm.). Beyond this timeframe, they may remain BLM sensitive species as long as they meet either of the following criteria: (1) either species has recently undergone, is undergoing, or is predicted to undergo a downward trend such that the viability of the species or a distinct population segment of the species is at risk across all or a significant portion of the species' range; or (2) either species depends on ecological refugia or specialized or unique habitats on BLM-administered lands, and there is evidence that such areas are threatened with alteration such that the continued viability of the species in the area would be at risk (BLM 2008, entire; Dawson 2023, pers. comm.).

Once delisted, or if S. glaucus or S. dawsoniae are removed from BLM's sensitive species list, the measures specific to listed and sensitive species in these RMPs would no longer apply ( e.g., buffers around oil and gas development). However, the majority of measures in these RMPs are not unique to Colorado hookless cactus, but rather provide protections for resources in NCAs and ACECs and for other BLM sensitive species where the species occur. While these conservation measures are not obligatory, BLM implements them to meet the goals and objectives identified in RMPs, unless there are waivers, exceptions, or modifications for a specific project, for effective land management and rangeland health as required under FLPMA (43 U.S.C. 1701 et seq. ). Continued responsible management of the landscapes in which the Colorado hookless cactus occurs, even if not directed specifically towards the species, will still provide benefit.

Further, approximately 30 percent of the land in S. glaucus AUs and 41 percent of the land in S. dawsoniae AUs have special BLM land management designations in the form of NCAs, ACECs, a WSA, and a Wilderness Area (Service 2025, pp. 19-22). These designations limit or exclude the authorization of certain land uses, and some designations were specifically created for the conservation of natural resources; of 11 ACECs across the species' range, 8 specifically reference the protection of Colorado hookless cactus as a foundational goal. The protections provided by these management designations are not contingent upon the species' federally listed status, and these designations help to facilitate the maintenance and recovery of cactus occurrences, because they are areas where Colorado hookless cactus is not likely to be disturbed or adversely altered by land-use actions (Krening and Dawson 2020, p. 26). We discuss the specific protections each of these areas provides under the relevant stressors above.

The BLM RMP for the Dominguez-Escalante NCA identifies Colorado hookless cactus as a priority species and includes species-specific protections that will continue into the future under the existing RMP. The species-specific protections include controlling noxious weeds, minimizing livestock use in Escalante Canyon, reducing route density within 200 m (656 ft) of Colorado hookless cactus occurrences, and limiting trail development and permitted activities in known habitat. BLM will continue monitoring and have a conservation goal that at least 80 percent of populations show evidence of recruitment. Species-specific restrictions will also be applied within 100 m (328 ft) of any known occurrences for Colorado hookless cactus as long as it is a BLM sensitive species, in addition to the protections described above (BLM 2017, pp. II., 34-35). The NCA contains the Dominguez Canyon WSA and the Dominguez Canyon Wilderness.

BLM designates ACECs under FLPMA (43 U.S.C. 1702(a), 1712(c)(3)). ACECs do not have an expiration date, and removing an ACEC designation is not simple. A withdrawal of an ACEC can be made only by the Office of the Secretary (43 U.S.C. 1714); additionally, the ACECs that include S. glaucus and S. dawsoniae habitat were designated to protect multiple species and resources in addition to the Colorado hookless cactus (Service 2025, table 6, pp. 19-22). Likewise, NCAs, WSAs, and Wilderness Areas are designated to protect multiple resources, not only the Colorado hookless cactus (1964 Wilderness Act (Pub. L. 88-577)). Therefore, it is unlikely that these special management designations will change in the coming decades.

We describe each of these BLM areas with special management designations, and the specific protections they provide, in table 6 of the SSA report (Service 2025, pp. 19-22) and in table 2 of the 5-year status review (Service 2021, pp. 10-11). The current condition of the species provides insight into the effectiveness of these protected areas; all but one of the S. glaucus AUs and both S. dawsoniae AUs have high resiliency, including moderate to high habitat condition (see Current Condition, below; Service 2025, pp. 26-27). This conclusion demonstrates that both due to the species' natural hardiness and to these land protections and other conservation efforts, stressors are not currently meaningfully affecting the species' survival and growth.

No regulatory mechanisms or conservation efforts protect Colorado hookless cactus on private, State, or local lands.

International trade in all Sclerocactus species is regulated by the Convention on International Trade in Endangered Species of Wild Flora and Fauna (CITES), an international agreement ratified by most countries worldwide since 1975. The purpose of CITES is to regulate the international wildlife trade to safeguard certain species from over-exploitation. S. glaucus is currently listed as an Appendix I species under CITES and will remain an Appendix I species after delisting under the Act. Trade in Appendix I species is permitted only in exceptional circumstances. Under CITES, exporters must obtain a permit for international shipment of specimens. Because Appendix I applies to the cactus family ( Cactaceae ), S. dawsoniae is also considered an Appendix I species (CITES 2024, entire; Leuteritz 2024, entire). More information on CITES can be found at: https://cites.org/eng/disc/how.php.

We note that, by using the SSA framework to guide our analysis of the scientific information documented in the SSA report, we have analyzed the cumulative effects of identified threats and conservation actions on the species. To assess the current and future condition of the species, we evaluate the effects of all the relevant factors that may be influencing the species, including threats and conservation efforts. Because the SSA framework considers not just the presence of the factors, but to what degree they collectively influence risk to the entire listed entity, our assessment integrates the cumulative effects of the factors and replaces a standalone cumulative-effects analysis.

For example, to assess current resiliency, we used a condition category table (see Current Condition below) to analyze how livestock use, invasive species, oil and gas development, OHV recreational use, development and maintenance of utility corridors, and the effects of global climate change, taken together, may influence habitat condition, survivorship, population size, and water availability. Similarly, we analyzed how changes in these stressors, when considered together, may influence habitat condition, survivorship, population size, and water availability in the future. We also considered how these same stressors may affect the species' current and future redundancy and representation.

In our SSA report, we evaluate current condition by examining current levels of resiliency in the eight S. glaucus AUs and two S. dawsoniae AUs, and implications for redundancy and representation. Here, we summarize our evaluation of current condition for resiliency, redundancy, and representation. Additional detail regarding our analysis is provided in the SSA report (Service 2025, pp. 22-28).

We describe the resiliency for each of the 10 AUs in terms of the habitat and demographic factors needed by the Colorado hookless cactus (Service 2025, pp. 10-16, 22-28). We developed a categorical model to calibrate resiliency based on the range of habitat and demographic conditions in each AU. In a categorical model, we first identify resource or demographic factors that contribute to the species' resiliency; typically, these factors align with the individual resource needs and population-level needs we identified in the SSA analysis. We then define threshold values for each identified resource or demographic factor that represent high, moderate, or low levels of that factor. Finally, we evaluate whether the current levels of each resource or demographic factor in an AU fall within the predetermined thresholds for a high, moderate, or low score for the category; we then average these scores for each category to develop an overall current resiliency score for each AU.

For Colorado hookless cactus, our categorical model assessed the resiliency of each AU by evaluating (1) the condition of habitat in each AU based on an index that evaluates a number of habitat factors including invasive species cover, bare ground, native perennial cover, the relative size of the AU, and the probability of occurrence based on a BLM habitat suitability model (Holsinger and Krening 2021, p. 5); (2) the summer water deficit, a proxy for drought and soil moisture that approximates the availability of water; (3) survival rates for each species, calculated from long-term monitoring data collected by BLM and the Denver Botanic Gardens; and (4) a minimum population size estimate for each AU provided by BLM (Service 2025, pp. 22-24). We selected these habitat and demographic factors based on their importance to the species' resiliency and because we could evaluate them relatively consistently across all 10 AUs. We then used this categorical model as a key to evaluate resiliency for each AU by systematically evaluating the current condition of each habitat and demographic factor. The AUs with higher overall resiliency are at less risk from potential stochastic events, such as climatic variation, than AUs with lower overall resiliency. Our SSA report provides additional detail regarding the methodology we used to evaluate resiliency for each of the 10 AUs (Service 2025, pp. 22-28).

When measured against the metrics outlined in our categorical model (Service 2025, pp. 22-24), all but one of the S. glaucus AUs have high resiliency. This finding is due to the large estimated number of individuals in each AU, high levels of survivorship, adequate habitat resources, and a current summer water deficit (averaged over the past decade) that is similar to the historical average. The only AU that does not have high resiliency is the Palisade AU, which has moderate resiliency overall due to its extremely small population size and moderate score for the habitat condition index. This AU is considerably smaller in area than the other AUs. A major highway (U.S. Interstate 70) and the Colorado River also cut through this AU, fragmenting the habitat. Additionally, a high proportion of this AU is on private and State lands, which contain existing forms of development ( e.g., truck stop, shooting range, power plant) that present additional stressors to the species and its habitat (Lincoln 2021, pers. comm.).

Both S. dawsoniae AUs have high resiliency (see table 1 below). This score is due to the high estimated number of individuals in each AU, high levels of survivorship, high and moderate availability of habitat features that support the species, and a current summer water deficit that is similar to the historical average. The stressors operating in the Plateau Creek AU and the Roan Creek AU are comparable, but the Plateau Creek AU is geographically smaller, which partly influences its lower rating for the population size category (Lincoln 2021, pers. comm.).

Rangewide monitoring efforts have demonstrated a stable trend over recent years and have also provided a detailed understanding of demographic features and population dynamics. Across their limited ranges, both species of Colorado hookless cactus are relatively abundant, which contributes to the high levels of resiliency in all but one AU. At the time of listing in 1979 (prior to current taxonomic revisions—See Background for discussion of taxonomy), it was thought that the combined total for what are now considered to be four separate species ( S. glaucus, S. dawsoniae, S. brevispinus, and S. wetlandicus ) consisted of approximately 15,000 individual plants in both Colorado and Utah (44 FR 58868, October 11, 1979). After the taxonomic split in 2009, estimates from CNHP suggested there were approximately between 19,000 and 22,000 plants for the total rangewide number of individuals in both species ( S. glaucus and S. dawsoniae ), based on observations within element occurrence records, which do not represent a total count of plants for the entire range of the species (Service 2025, pp. 13-14). However, as we discuss below, we now know that there are many more plants than previously reported.

BLM conducted a novel sampling-based procedure to estimate the minimum population size of S. glaucus from 16 sampled macroplots across the species' range that encompass a variety of different habitat conditions informed by a species-specific habitat index (Krening et al. 2021a, entire). They estimated the total minimum population size for the taxon by applying the average minimum plant density estimate of the sampled macroplots to S. glaucus' total rangewide occupied habitat acreage. To provide a conservative rangewide estimate across all landownerships (BLM, private, State, and local lands), BLM applied the 90 percent lower confidence level value as the minimum population size for each AU. Despite their conservative approach, this method produced a population size estimate for the species that is much higher than previous estimates (Krening et al. 2021a, entire).

BLM conducted a similar procedure to estimate the minimum population size for S. dawsoniae (Krening and Holsinger 2024, entire; Service 2025, pp. 20-21). BLM estimated minimum plant densities in 30 sampled macroplots using the same methods as the S. glaucus study described above. BLM did not apply the 90 percent lower confidence level value as the minimum population size for each S. dawsoniae AU because of the increased sample size and spatially balanced design (Krening and Holsinger 2024, entire).

Using this sampling-based procedure to determine the minimum number of plants in each AU, S. glaucus has a minimum population estimate of at least 68,120 plants (90 percent lower confidence level estimate), and S. dawsoniae has a minimum population estimate of 17,362 plants (Service 2025, p. 14; Krening et al. 2021a, p. 8; Krening and Holsinger 2024, entire). Based on the most recent (2023) BLM monitoring report for the species, both species demonstrate an increasing trend compared to the baseline density (Krening and DePrenger-Levin 2023, pp. 6-7).

Redundancy describes the number and distribution of AUs, such that the greater the number and the wider the distribution of the AUs, the better the Colorado hookless cactus can withstand catastrophic events. The plausibility of catastrophic events also influences species' redundancy; if catastrophic events are unlikely within the range of the species, catastrophic risk is inherently lower. We are unaware of any plausible activity or naturally occurring event that would constitute a catastrophic event for Colorado hookless cactus. For example, fire is not a common occurrence in S. glaucus or S. dawsoniae habitat as this habitat lacks the fuels to sustain a burn, though increased invasive species presence could elevate this risk (Service 2025, p. 28). Additionally, the range of S. glaucus and S. dawsoniae contains natural and humanmade barriers ( i.e., rivers, canyons, highways) that would constrain the spread of any catastrophic fire throughout the entire range of Colorado hookless cactus. Redundancy for narrow endemic species is intrinsically limited; however, S. glaucus plants are distributed broadly across the range of the species in eight AUs, providing redundancy throughout its relatively small geographic range. With only two AUs, S. dawsoniae redundancy is limited; however, as a narrowly endemic plant, it has likely always had a small range and limited redundancy, and there has not been a known decrease in redundancy compared with its historical range. Additionally, given the lack of plausible catastrophic events across the range of S. glaucus and S. dawsoniae, even the narrow range of S. dawsoniae does not introduce appreciable catastrophic risk.

S. glaucus and S. dawsoniae exhibit some ecological and morphological variability, coupled with low to moderate genetic diversity among AUs (McGlaughlin and Naibauer 2021, p. 22). Inbreeding is not an immediate concern for either species (McGlaughlin and Naibauer 2021, p. 22). Additionally, S. glaucus demonstrates sufficient connectivity, which results in ongoing and recent genetic exchange (McGlaughlin and Naibauer 2021, p. 2). S. dawsoniae is genetically isolated and diverged from S. glaucus; all genetic analyses support that S. dawsoniae is a distinct entity (McGlaughlin and Naibauer 2024, entire).

In our SSA report, we forecasted the resiliency of S. glaucus and S. dawsoniae AUs and their redundancy and representation to mid-century (the mean of projections for 2040 to 2069) using a range of plausible future scenarios. After mid-century, the changes in climate conditions that different climate models and emissions scenarios project begin to diverge widely (Rangwala et al. 2021, p. 4); in other words, the spread of potential projected temperature increases broadens substantially after mid-century. Therefore, we focused our analysis of future condition on mid-century to avoid the large uncertainty in climate change at the end of the twenty-first century (Rangwala et al. 2021, p. 4). We also selected this timeframe because we can make reliable predictions regarding changes in other stressors to S. glaucus and S. dawsoniae, such as land management. This timeframe encompasses at least one revision to BLM resource management plans and is biologically meaningful to S. glaucus and S. dawsoniae for us to begin to understand the response of ecosystems to those changes.

We used future climate models downscaled to the ranges of S. glaucus and S. dawsoniae, in combination with forecasted changes in the location and intensity of stressors, to develop three future scenarios and evaluate the condition of S. glaucus and S. dawsoniae under each of those scenarios. By capturing a range of plausible future scenarios, we can assume that actual future conditions will likely fall somewhere between these projected scenarios. Detailed descriptions of each scenario are available in the SSA report (Service 2025, pp. 28-36).

As many of the stressors that affect S. glaucus and S. dawsoniae occur on BLM lands, future scenarios were developed with input from BLM about plausible changes in the location and intensity of stressors on BLM land. Given some level of uncertainty about the conditions that will occur by mid-century, these scenarios represent three future conditions—optimistic, continuation, and pessimistic—to capture the plausible range of future conditions the species may experience. Therefore, our evaluation of future conditions presents a plausible range of expected species responses. While the metrics used to assess the current resiliency of S. glaucus and S. dawsoniae AUs are quantitative, we do not have a reliable way to quantitatively forecast these metrics into the future. Instead, future conditions are expressed qualitatively, using the results of our current condition analysis as the baseline. Species experts used professional judgment to predict how the species and their habitats would respond to each future scenario (Krening 2021, pers. comm.).

Optimistic. In the optimistic scenario, the overall resiliency of each AU for both species remains the same as the current condition. Although the overall resiliency of each AU does not change, the resiliency of the Plateau Creek ( S. dawsoniae ) and Devil's Thumb ( S. glaucus ) AUs increases slightly due to higher ratings for habitat conditions and population size, respectively. Under this scenario, decreases in activities such as grazing and OHV use (consistent with current stipulations in BLM grazing permits and travel management plans) that degrade S. glaucus and S. dawsoniae habitat allow for passive restoration, which leads to improved habitat conditions in the Plateau Creek AU and an increase in population size in the Devil's Thumb AU. Summer water deficit is expected to slightly decrease, meaning more water is available for germination, growth, and reproduction. Redundancy and representation for S. dawsoniae increase under this scenario, as compared to the current condition, due to an increase in resiliency in the Plateau Creek AU. Redundancy and representation of S. glaucus also increase slightly under this scenario due to an increase in resiliency in the Devil's Thumb AU.

Continuation. In the continuation scenario, we expect resiliency, redundancy, and representation to remain relatively unchanged from the current condition. Resiliency of the Palisade AU ( S. dawsoniae ) is moderate; resiliency of all other AUs is high. Despite the increase in water deficit as compared to historical conditions under this scenario (meaning that less water would be available to the plants), this slight decrease in water availability would have minimal impact because it is well within the range of variability that S. glaucus and S. dawsoniae have historically experienced.

Pessimistic. In the pessimistic scenario, hot and dry conditions may negatively affect survivorship and recruitment of the species. Water deficit is more than one standard deviation higher than the historical mean, meaning that, on average, less water is available to support germination, growth, and reproduction. Under the pessimistic scenario, although BLM land management direction and special land management designations do not change, continued ground disturbance and habitat degradation may occur. This projection could be driven by several factors: Livestock grazing without corrective action for impacts to the range may lead to increased impacts to habitat and plant communities; and increasing OHV use (due to increased demand from population growth), increasing demand for oil and gas development and utility corridor development, and an increase in invasive plant species may negatively affect the amount and quality of habitat available and reduce survival rates and overall population sizes, leading to a decrease in resiliency in the Whitewater, Palisade, North Fruita Desert, Devil's Thumb, Cactus Park, Gunnison Gorge, and Gunnison River East AUs ( S. glaucus ) and in the Plateau Creek AU ( S. dawsoniae ). Overall, one S. glaucus AU is in high condition, six S. glaucus AUs are in moderate condition, and one is in low condition. S. dawsoniae has one AU in high condition and one AU in moderate condition.

Redundancy and representation of S. glaucus decreases slightly in this scenario due to the decrease in resiliency in all but one AU; although no AUs are expected to be extirpated, each AU contains multiple clusters of plants, and some diversity within AUs could be lost. However, even in the most pessimistic plausible scenario, all but 1 of the 8 AUs are expected to have at least 500 to 10,000 plants, thereby preserving much of the species' redundancy and representation. Despite high and moderate resiliency of the two S. dawsoniae AUs, representation and redundancy are lower than under the optimistic and continuation scenarios and under current condition due to the Plateau Creek AU's moderate resiliency; this AU had high resiliency under all other scenarios. With only two known S. dawsoniae AUs, the loss of one of these AUs due to catastrophic, natural, or human-caused events would cause a severe loss of redundancy and representation of the species; however, loss of either AU is not expected, even under the pessimistic scenario. As with S. glaucus, some variation within AUs could be reduced under this scenario; however, ecological, morphological, and genetic variation will continue to be represented by the multiple AUs across S. dawsoniae' s range.

Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for determining whether a species meets the definition of an endangered species or a threatened species. The Act defines an “endangered species” as a species in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act requires that we determine whether a species meets the definition of an endangered species or a threatened species because of any of the following factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) Overutilization for commercial, recreational, scientific, or educational purposes; (C) Disease or predation; (D) The inadequacy of existing regulatory mechanisms; or (E) Other natural or manmade factors affecting its continued existence.

When we listed the Colorado hookless cactus as threatened on October 11, 1979, we identified the potential development of oil shale deposits and gold mining (Factor A), off-road vehicle use (Factor A), collecting pressure (Factor B), livestock grazing (Factor C), and an inadequacy of existing regulatory mechanisms (Factor D) as threats to the existence of the species (44 FR 58868, October 11, 1979). In our SSA, we evaluated these stressors and additional stressors that were identified after the time of listing. Much more is presently known about the species' stressors than at the time of listing.

Several of the stressors identified in the original listing decision are no longer relevant. Given the taxonomic changes, and thus range extent changes, that the species has undergone in the past 40 years, oil shale and tar sands development and hybridization are no longer relevant stressors (Service 2025, p. 16). Additionally, collection from the wild has not occurred at the level anticipated at the time of listing; collection is not having population- or species-level effects on either species (Krening and Dawson 2020, p. 36). Thus, stressors that could influence both species of the Colorado hookless cactus at the AU or species scale include livestock use (Factor A), invasive species (Factor A), oil and gas development (Factor A), OHV recreational use (Factor A), development and maintenance of utility corridors (Factor A), and the effects of global climate change (Factor A). Although livestock grazing was categorized as a stressor under Factor C at the time of listing, we believe that the effects of livestock grazing are better characterized by Factor A. The spines on cactus plants generally make them undesirable forage to livestock; however, livestock can degrade habitat conditions by trailing through and trampling habitat. Only on rare occasions do cattle directly trample or dislodge cactus plants.

We also evaluated a variety of conservation efforts and mechanisms across the 10 AUs of both species that either reduce or ameliorate stressors or improve the condition of habitats or demographics. These conservation efforts and mechanisms include five BLM RMPs that, taken together, cover the range of the species. They include motorized recreation restrictions, energy development restrictions, and grazing management; research to aid in better understanding the effects of stressors on the species and guide conservation efforts; and habitat improvements and vegetation management (Service 2025, pp. 19-22, 28-36). With 72 percent of S. glaucus and 68 percent of S. dawsoniae AU acres occurring on BLM land, BLM's implementation of the regulatory mechanisms in their resource planning documents on all of their lands within the range of the species (Factor D) has helped to address the stressors we identified under Factors A and B. While we cannot attribute the currently high resiliency of both species ( S. glaucus and S. dawsoniae ) to one specific conservation measure, this high resiliency demonstrates the amelioration of relevant stressors and the adequacy of the existing regulatory mechanisms, both due to the combination of conservation measures in place and the hardiness of the plants (having a demonstrated ability to tolerate nearby disturbance).

In addition to the implementation of measures that minimize impacts to the Colorado hookless cactus on all BLM lands, approximately 30 percent of the land in S. glaucus AUs and 41 percent of the land in S. dawsoniae AUs have special BLM land management designations (Factor D), which further limit or exclude the authorization of certain land uses and further help to facilitate the maintenance and recovery of cactus occurrences, because they are areas where Colorado hookless cactus occurrences are not likely to be disturbed or adversely altered by land-use actions (Krening and Dawson 2020, p. 26). The protections provided by these management designations are not contingent upon the species' federally listed status.

Currently, seven of the eight S. glaucus AUs have high resiliency, and one AU has moderate resiliency (Service 2025, pp. 26-28). The highly resilient AUs have high estimated numbers of individuals, high levels of survivorship, adequate habitat resources, and a current water deficit that is similar to the historical average. One AU has moderate resiliency due to its extremely small population size and moderate score for the habitat index; this AU covers a considerably smaller area than the other AUs. Rangewide monitoring has shown a stable trend for Colorado hookless cactus, with no indication of widespread decline. This monitoring has also informed our understanding that S. glaucus is currently much more abundant than originally estimated at the time of listing in 1979. At the time of listing, and prior to the taxonomic splits between the 2 Utah Sclerocactus species and Colorado's S. glaucus and S. dawsoniae, it was thought that the combined total for the now 4 species consisted of approximately 15,000 individual plants in both Colorado and Utah; now, the minimum population estimate for S. glaucus alone is 68,120 plants (90 percent lower confidence level).

We are unaware of any plausible activity or naturally occurring event that would constitute a catastrophic event for this species. Thus, while the species is a narrow endemic with a small range compared to wide-ranging species, S. glaucus' s relatively large range for a narrow endemic, with eight AUs, and the lack of plausible catastrophic events reduce catastrophic risk for this species, thereby enhancing redundancy. The individuals within and among the AUs also exhibit genetic, ecological, and morphological diversity, contributing to the species' representation.

Moreover, our understanding of the species' stressors has changed since the time Colorado hookless cactus was listed. Multiple identified stressors are no longer relevant to the species, given past taxonomic changes and subsequent changes in the geographic range of the species ( i.e., oil shale and tar sands development) or because they are not occurring at a scale anticipated at the time of listing ( i.e., collection). We also have found that, while OHV use and invasive species have the potential to detrimentally impact Colorado hookless cactus, they have caused only minor, localized impacts (Krening and Dawson 2020, pp. 35, 38). Oil and gas development occurs in only a small portion of three of the eight S. glaucus AUs.

Since Colorado hookless cactus was listed, the BLM land in the species' range now includes NCAs, ACECs, a WSA, and a Wilderness Area (Service 2025, pp. 19-22). These designations limit or exclude the authorization of certain land uses, and most of these designations specifically reference the protection of Colorado hookless cactus as a foundational goal. The protections provided by these management designations are not contingent upon the species' federally listed status, and these designations have helped to facilitate the maintenance and recovery of cactus occurrences, because they are areas where Colorado hookless cactus is not likely to be disturbed or its habitat adversely altered by land-use actions (Krening and Dawson 2020, p. 26). While we cannot attribute the currently high resiliency of all but one AU to one specific conservation measure, this high resiliency demonstrates the amelioration of relevant stressors, both due to the combination of conservation measures in place and the hardiness of the plant (which has shown an ability to tolerate nearby disturbance).

Given the currently high level of resiliency in seven of the eight S. glaucus AUs and moderate resiliency of one AU, the additional plants we now know to occur throughout the species' range, the lack of significant imminent stressors, and the low likelihood of catastrophic events, we find that S. glaucus currently has sufficient ability to withstand stochastic and catastrophic events, and to adapt to environmental changes.

For the purposes of our analysis of the species' future condition, we defined the foreseeable future for both S. glaucus and S. dawsoniae to mid-century (the mean of 2040 to 2069). After mid-century, the changes in climate conditions that different climate models and emissions scenarios project begin to diverge widely (Rangwala et al. 2021, p. 4); in other words, after mid-century, there is a wide variability in temperature projections among different climate models. This variability makes future conditions beyond the mid-century difficult to reliably assess. Therefore, we focused our analysis of future condition on mid-century to avoid the large degree of uncertainty in how climate change is projected to manifest at the end of the twenty-first century (Rangwala et al. 2021, p. 4). We also selected this timeframe because it allows us to reliably predict changes in species' stressors and land management and is biologically meaningful to both species for us to begin to understand the response of ecosystems to those changes.

By mid-century, we anticipate a range of plausible future conditions for S. glaucus. Under the optimistic scenario, the condition of the species is likely to improve over the current condition, with resiliency projected to increase slightly in one S. glaucus AU. BLM's closure of certain OHV routes and effective implementation of changes in grazing permit stipulations would lead to decreased grazing and OHV pressures, causing improved habitat conditions and an increase in the number of individuals in the AU (Service 2025, pp. 31-32). In the continuation scenario, we expect resiliency, redundancy, and representation to remain relatively unchanged from the current condition, because stressors and conservation efforts would remain very similar to what the species is currently experiencing.

In the pessimistic scenario, although BLM management planning documents and special land management designations do not change, grazing without corrective action for impacts to the range, an increase in OHV use, increased demand for utility corridor development, an increase in invasive plant species, and a considerable decrease in water availability due to climate change may negatively affect the amount and quality of habitat available, and reduce survival rates and overall population sizes. This is the only scenario in which the condition of S. glaucus is projected to decline: One AU's resiliency remains high, six AUs decrease from high to moderate resiliency, and one AU decreases to low resiliency. Even under this pessimistic scenario, the species maintains moderate levels of survival and high or moderate habitat condition in the majority of AUs, despite increasing stressors. In all three scenarios, all eight AUs will remain extant, thereby continuing to contribute to the redundancy and representation of the species.

Given these future projections of resiliency, redundancy, and representation to mid-century, S. glaucus could experience a slight decrease in viability under one of the three future scenarios (the pessimistic scenario); however, even in this most pessimistic scenario, all AUs will remain extant and seven of the eight AUs will have moderate to high resiliency.

Two factors support this consistently moderate to high future resiliency: BLM conservation actions and the species' biological characteristics. First, the high to moderate resiliency of S. glaucus AUs is, in part, due to land protections and regulations implemented by BLM (Factor D) that will continue to be implemented into the future, even in the absence of protections afforded by the Act, as described under Conservation Efforts and Regulatory Mechanisms above. These protections will continue to limit the potential effects of stressors on S. glaucus in the future.

Second, independent of future BLM management, the species' biological characteristics moderate its response to increasing stressors. S. glaucus is a habitat generalist, which means the species is not constrained to a specific habitat niche; the species' flexible resource requirements increase its resiliency to potential future increases in stressors and its ability to adapt to future change (representation). This determination is evidenced by S. glaucus' past ability to maintain high survivorship and resiliency, even in the face of ongoing stressors that the Service originally determined could lead to decline ( e.g., OHV use, invasive species). Additionally, multiple modeling efforts have concluded that Colorado hookless cactus likely has low vulnerability to climate change, given its dispersal capabilities and opportunities for expansion into vast areas of suitable habitat (Krening and Dawson 2020, pp. 43-44). Although conditions could become considerably drier under the pessimistic climate scenario, S. glaucus is hardy and already adapted to arid environments. Individuals of this species live many decades and have maintained healthy recruitment and survival, even through droughts and other climatic variation in the past (BLM 2018, pp. 14-15; Hegewisch and Abatzoglou 2020, entire). These characteristics allow the species to maintain moderate survivorship and resiliency, even under the pessimistic scenario.

After evaluating threats to the species and assessing the cumulative effect of the threats under the Act's section 4(a)(1) factors, the species currently has sufficient levels of resiliency, redundancy, and representation, and is anticipated to maintain sufficient levels under each of the future scenarios, such that S. glaucus will be able to withstand stochastic events, catastrophic events, and environmental change now and into the foreseeable future. Thus, after assessing the best available information, we conclude that S. glaucus is not in danger of extinction now or likely to become so in the foreseeable future throughout all of its range.

Currently, both S. dawsoniae AUs have high resiliency (Service 2025, pp. 26-28). The highly resilient AUs have moderate to high estimated numbers of individuals ( i.e., a minimum population estimate of 17,362 plants total), high levels of survivorship, high and moderate condition of habitat features, and a current water deficit that is similar to the historical average. These high current levels of resiliency reduce the current extinction risk for S. dawsoniae because they lower the risk to the species from stochastic variation. Rangewide monitoring has shown a stable trend for S. dawsoniae, with no indication of widespread decline and greater abundance than originally estimated. When Colorado hookless cactus was listed in 1979 and prior to the taxonomic splits between the 2 Utah Sclerocactus species and Colorado's S. glaucus and S. dawsoniae, it was thought that the combined total for the now 4 species consisted of approximately 15,000 individual plants in both Colorado and Utah; now, the minimum population estimate for S. dawsoniae plants alone is 17,362.

Additionally, the two AUs and the individuals within the AUs exhibit ecological and morphological variability (McGlaughlin and Naibauer 2021, p. 22), contributing to the representation of the species. In terms of redundancy, we are unaware of any plausible activity or naturally occurring event that would constitute a catastrophic event for this species. Given the lack of plausible catastrophic events across the range of S. dawsoniae, even its narrow range (two AUs) does not introduce appreciable catastrophic risk.

Moreover, our understanding of stressors to the Colorado hookless cactus has changed since the time of the original listing rule (44 FR 58868; October 11, 1979). Multiple identified stressors are no longer relevant to the species, given past taxonomic changes and subsequent changes in the geographic range of the species ( e.g., oil shale and tar sands development) or because they are not occurring at a scale anticipated at the time of listing ( i.e., collection). We also have found that, while OHV use and invasive species had the potential to detrimentally impact the species, they have caused only minor, localized impacts (Krening and Dawson 2020, pp. 35, 38).

Since Colorado hookless cactus was listed, NCAs, ACECs, a WSA, and a Wilderness Area have been designated on BLM land where the species occurs (Service 2025, pp. 19-22). These designations limit or exclude the authorization of certain land uses, and most of these designations specifically reference the protection of Colorado hookless cactus as a foundational goal. The protections provided by these management designations are not contingent upon the species' federally listed status, and these designations have helped to facilitate the maintenance and recovery of cactus occurrences, because they are areas where Colorado hookless cactus is not likely to be disturbed or adversely altered by land-use actions (Krening and Dawson 2020, p. 26). While we cannot attribute the currently high resiliency of both AUs to one specific conservation measure, this high resiliency demonstrates the amelioration of relevant stressors, both due to the combination of conservation measures in place and the hardiness of the plant (which has shown an ability to tolerate nearby disturbance).

By mid-century (the foreseeable future), we anticipate a range of plausible future conditions for S. dawsoniae. Under the optimistic scenario, the condition of the species improves, with resiliency expected to increase slightly in one S. dawsoniae AU due to decreased grazing and OHV pressures, causing improved habitat conditions. In the continuation scenario, we expect resiliency, redundancy, and representation to remain relatively unchanged from the current condition, as stressors and conservation efforts remain very similar to what the species is currently experiencing. In the pessimistic scenario, although BLM management planning documents and special land management designations do not change, continued livestock grazing without corrective action for impacts to the range, increasing demand for oil and gas development and utility corridor development, and an increase in invasive plant species will cause ground disturbance and habitat degradation that is projected to negatively affect the species, which would cause a decrease in resiliency in one of the two S. dawsoniae AUs. Additionally, only under this pessimistic scenario does water availability drop considerably below the historical average ( i.e., more than one standard deviation). This is the only scenario in which we foresee resiliency decreasing for either of the species' two AUs; one AU's resiliency remains high, and one AU decreases to moderate resiliency. Even in the pessimistic scenario, survivorship in both AUs remains high. In all three scenarios, both AUs will remain extant, thereby continuing to contribute to the redundancy and representation of the species.

Given these future projections of resiliency, redundancy, and representation to mid-century, S. dawsoniae could experience a slight increase in extinction risk under one of the three future scenarios; however, even in the pessimistic scenario, both AUs will remain extant with moderate to high resiliency. Two factors support this moderate to high future resiliency: BLM conservation actions and the species' biological characteristics. First, this high to moderate resiliency of S. dawsoniae AUs is, in part, due to land protections and regulations implemented by BLM (Factor D) that will continue to be implemented into the future even in the absence of protections afforded by the Act, as described under Conservation Efforts and Regulatory Mechanisms above. These protections will continue to limit the potential effects of stressors on S. dawsoniae in the future.

Second, independent of future BLM management, the species' biological characteristics moderate its response to increasing stressors. Like S. glaucus, S. dawsoniae is a habitat generalist, which means the species is not constrained to a specific habitat niche; the species' flexible resource requirements increase its resiliency to potential future increases in stressors and its ability to adapt to future change (representation). This finding is evidenced by S. dawsoniae' s past ability to maintain high survivorship and resiliency, even in the face of ongoing stressors that the Service originally determined could lead to decline ( e.g., OHV use, invasive species). Additionally, multiple modeling efforts have indicated that Colorado hookless cactus likely has low vulnerability to climate change, given its dispersal capabilities and opportunities for expansion into vast areas of suitable habitat (Krening and Dawson 2020, pp. 43-44). Although conditions could become considerably drier under the pessimistic climate scenario, S. dawsoniae is hardy and already adapted to arid environments. Individuals of this species live many decades and have maintained healthy recruitment and survival, even through droughts and other climatic variation in the past (BLM 2018, pp. 14-15; Hegewisch and Abatzoglou 2020, entire). These characteristics would allow S. dawsoniae to maintain high survivorship and moderate to high resiliency, even under the pessimistic scenario.

After evaluating threats to the species and assessing the cumulative effect of the threats under the Act's section 4(a)(1) factors, the species currently has sufficient levels of resiliency, redundancy, and representation, and is anticipated to maintain sufficient levels in each of the plausible future scenarios, such that S. dawsoniae will be able to withstand stochastic events, catastrophic events, and environmental change now and within the foreseeable future. Therefore, after assessing the best available information, we conclude that S. dawsoniae is not in danger of extinction now or likely to become so in the foreseeable future throughout all of its range.

Under the Act and our implementing regulations, a species may warrant listing if it is in danger of extinction or likely to become so within the foreseeable future throughout all or a significant portion of its range. Having determined that S. glaucus and S. dawsoniae are not in danger of extinction or likely to become so in the foreseeable future throughout all of their range, we now consider whether either may be in danger of extinction ( i.e., endangered) or likely to become so in the foreseeable future ( i.e., threatened) in a significant portion of its range—that is, whether there is any portion of the species' range for which both (1) the portion is significant; and (2) the species is in danger of extinction or likely to become so in the foreseeable future in that portion. Depending on the case, it might be more efficient for us to address the “significance” question or the “status” question first. We can choose to address either question first. Regardless of which question we address first, if we reach a negative answer with respect to the first question that we address, we do not need to evaluate the other question for that portion of the species' range.

In undertaking this analysis for S. glaucus and S. dawsoniae, we choose to address the status question first. We began by identifying portions of the range where the biological status of the species may be different from their biological status elsewhere in their range. For this purpose, we considered information pertaining to the geographic distribution of (a) individuals of the species, (b) the threats that the species face, and (c) the resiliency condition of populations.

For S. glaucus, we evaluated the range of the species to determine if the species is in danger of extinction now or likely to become so in the foreseeable future in any portion of its range. The range of a species can theoretically be divided into portions in an infinite number of ways. We focused our analysis on portions of the species' range that may meet the definition of an endangered species or a threatened species. For S. glaucus, we considered whether the threats or their effects on the species are greater in any biologically meaningful portion of the species' range than in other portions such that the species is in danger of extinction now or likely to become so in the foreseeable future in that portion. We examined the following threats: livestock use, invasive species, oil and gas development, OHV use, development and maintenance of utility corridors, and climate change, including cumulative effects.

Livestock use, invasive species, OHV use, development and maintenance of utility corridors, and climate change occur uniformly across the species' range; there are no portions of the species' range where these stressors occur more intensely. Oil and gas development is occurring in only three AUs (North Fruita Desert, Whitewater, and Palisade AUs), so this threat may be elevated in this area. However, despite this development activity, the North Fruita Desert and Whitewater AUs currently have high resiliency and are expected to maintain this high resiliency under two of three future scenarios. Under the pessimistic scenario, North Fruita Desert and Whitewater AUs have moderate resiliency. Oil and gas development is occurring in only a small portion of the Palisade AU (there is only one active well site across more than 9,269 ac (3,751 ha)), and, while this AU has moderate resiliency currently and could drop to low resiliency under the pessimistic scenario, this possible change is due to the AU's small size and thus inherently low number of plants, not due to oil and gas development. Thus, even though oil and gas development may be concentrated in these AUs, it is not producing a species' response that would indicate the plants therein are in danger of extinction now or in the foreseeable future.

Moreover, although the Palisade AU has a low population size and is the only AU to rank low in resiliency in any future scenario, the AU occupies the smallest area of any S. glaucus AU and contributes the least to the species' redundancy and representation. Therefore, this AU is not considered to be a biologically meaningful portion of the species' range where threats are impacting individuals differently from how they are affecting the species elsewhere in its range such that the status of the species in that portion differs from its status in any other portion of the species' range.

Overall, we found no biologically meaningful portions of S. glaucus' range where threats are impacting individuals differently from how they are affecting the species elsewhere in its range such that the status of the species in that portion differs from its status in any other portion of the species' range.

Therefore, we find that the species is not in danger of extinction or likely to become so within the foreseeable future in any significant portion of its range. This does not conflict with the courts' holdings in Desert Survivors v. Department of the Interior, 321 F. Supp. 3d 1011, 1070-74 (N.D. Cal. 2018) and Center for Biological Diversity v. Jewell, 248 F. Supp. 3d. 946, 959 (D. Ariz. 2017) because, in reaching this conclusion, we did not apply the aspects of the Final Policy on Interpretation of the Phrase “Significant Portion of Its Range” in the Endangered Species Act's Definitions of “Endangered Species” and “Threatened Species” (79 FR 37578, July 1, 2014), including the definition of “significant” that those court decisions held to be invalid.

For S. dawsoniae, we evaluated the range of the species to determine if the species is in danger of extinction now or likely to become so in the foreseeable future in any portion of its range. The range of a species can theoretically be divided into portions in an infinite number of ways. We focused our analysis on portions of the species' range that may meet the definition of an endangered species or a threatened species. For S. dawsoniae, we considered whether the threats or their effects on the species are greater in any biologically meaningful portion of the species' range than in other portions such that the species is in danger of extinction or likely to become so within the foreseeable future in that portion. We examined the following threats: livestock use, invasive species, oil and gas development, OHV use, development and maintenance of utility corridors, and climate change, including cumulative effects.

Overall, the threats to this species are uniformly distributed throughout its range, and we did not identify a significant concentration of threats or the species' response to those threats that would increase extinction risk in any portion. Oil and gas development occurs in both AUs, as does livestock use, OHV use, invasive species infestation, and development and maintenance of utility corridors. The small range of the species will not experience substantially different temperature or precipitation changes as a result of climate change.

We found no biologically meaningful portions of S. dawsoniae' s range where threats are impacting individuals differently from how they are affecting the species elsewhere in its range such that the status of the species in that portion differs from its status in any other portion of the species' range.

Therefore, we find that the species is not in danger of extinction or likely to become so within the foreseeable future in any significant portion of its range. This finding does not conflict with the courts' holdings in Desert Survivors v. Department of the Interior, 321 F. Supp. 3d 1011, 1070-74 (N.D. Cal. 2018) and Center for Biological Diversity v. Jewell, 248 F. Supp. 3d. 946, 959 (D. Ariz. 2017) because, in reaching this conclusion, we did not apply the aspects of the Final Policy on Interpretation of the Phrase “Significant Portion of Its Range” in the Endangered Species Act's Definitions of “Endangered Species” and “Threatened Species” (79 FR 37578, July 1, 2014), including the definition of “significant” that those court decisions held to be invalid.

Based on the best scientific and commercial data available, we determine that S. glaucus and S. dawsoniae do not meet the definition of an endangered species or a threatened species in accordance with sections 3(6) and 3(20) of the Act. In accordance with our regulations at 50 CFR 424.11(e)(2) currently in effect, S. glaucus and S. dawsoniae have recovered to the point at which they no longer meet the definition of an endangered species or a threatened species. Therefore, we are removing Colorado hookless cactus ( S. glaucus and S. dawsoniae ) from the Federal List of Endangered and Threatened Plants.

This rule revises 50 CFR 17.12(h) by removing Colorado hookless from the Federal List of Endangered and Threatened Plants. On the effective date of this rule (see DATES , above), the prohibitions and conservation measures provided by the Act, particularly through sections 7 and 9, will no longer apply to this species. Federal agencies will no longer be required to consult with the Service under section 7 of the Act in the event that activities they authorize, fund, or carry out may affect Colorado hookless cactus ( S. glaucus and S. dawsoniae ).

There is no critical habitat designated for this species, so there will be no effect to 50 CFR 17.96.

Section 4(g)(1) of the Act requires us, in cooperation with the States, to implement a monitoring program for not less than 5 years for all species that have been recovered. Post-delisting monitoring (PDM) refers to activities undertaken to verify that a species delisted due to recovery remains secure from the risk of extinction after the protections of the Act no longer apply. The primary goal of PDM is to monitor the species to ensure that its status does not deteriorate, and if a decline is detected, to take measures to halt the decline so that proposing it as endangered or threatened is not again needed. If at any time during the monitoring period data indicate that protective status under the Act should be reinstated, we can initiate listing procedures, including, if appropriate, emergency listing.

We have prepared a PDM plan for Colorado hookless cactus ( S. glaucus and S. dawsoniae ). We published a notice of availability of a draft PDM plan with the proposed delisting rule (88 FR 21582, April 11, 2023), and we addressed all comments to the plan under Summary of Comments and Recommendations and revised the draft PDM plan according to the information we received. Therefore, we consider the plan final. As discussed in the proposed rule, the PDM plan: (1) Summarizes the status of Colorado hookless cactus ( S. glaucus and S. dawsoniae ) at the time of proposed delisting; (2) describes frequency and duration of monitoring; (3) discusses monitoring methods and potential sampling regimes; (4) defines what potential triggers will be evaluated to address the need for additional monitoring; (5) outlines reporting requirements and procedures; (6) proposes a schedule for implementing the PDM plan; and (7) defines responsibilities. It is our intent to work with our partners toward maintaining the recovered status of Colorado hookless cactus ( S. glaucus and S. dawsoniae ).

In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951, May 4, 1994), Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments), the President's memorandum of November 30, 2022 (Uniform Standards for Tribal Consultation; 87 FR 74479, December 5, 2022), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with federally recognized Tribes and Alaska Native Corporations on a government-to-government basis. In accordance with Secretaries' Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for healthy ecosystems, to acknowledge that Tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to Tribes. We notified the Ute Mountain, Jicarilla Apache Nation, Southern Ute, Ute Mountain Ute, and Navajo Nation Tribes of our recommendation to delist the Colorado hookless cactus in our 5-year status review in 2021, and of the proposed delisting rule (88 FR 21582, April 11, 2023). We did not receive comments from Tribes, and we are not aware of any Tribal interests or concerns associated with this final determination.

A complete list of references cited in this rulemaking is available on the internet at https://www.regulations.gov and upon request from the Colorado Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT ).

The primary authors of this rule are the staff members of the Fish and Wildlife Service's Species Assessment Team and the Colorado Ecological Services Field Office.

Paul Souza, Regional Director, Region 8, Exercising the Delegated Authority of the Director of the U.S. Fish and Wildlife Service, approved this action on April 24, 2025, for publication. On May 21, 2025, Paul Souza authorized the undersigned to sign the document electronically and submit it to the Office of the Federal Register for publication as an official document of the U.S. Fish and Wildlife Service.

Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below: