This rule does not meet the definition of significant regulatory action contained in section 3(f) of Executive Order (E.O.) 12866 and is not subject to review by the Office of Management and Budget (OMB).

This final rule has been reviewed under E.O. 12988, Civil Justice Reform. It is not intended to have a retroactive effect. The Pork Promotion, Research, and Consumer Information Act of 1985 (Act) states that the statute is intended to occupy the field of promotion and consumer education involving pork and pork products and of obtaining funds thereof from pork producers and that the regulation of such activity (other than a regulation or requirement relating to a matter of public health or the provision of State or local funds for such activity) that is in addition to or different from the Act may not be imposed by a State.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under Sec. 1625 of the Act, a person subject to an order may file a petition with the United States Department of Agriculture (USDA) stating that such order, a provision of such order or an obligation imposed in connection with such order is not in accordance with the law; and requesting a modification of the order or an exemption from the order. Such person is afforded the opportunity for a hearing on the petition. After the hearing, the USDA would rule on the petition. The Act provides that the district court of the United States in the district in which a person resides or does business has jurisdiction to review the USDA's determination, if a complaint is filed no later than 20 days after the date such person receives notice of such determination.

This final rule has also been reviewed under E.O. 13175, Consultation and Coordination with Indian Tribal Governments. E.O. 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on: (1) policies that have tribal implication, including regulation, 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. The Agricultural Marketing Service (AMS) has assessed the impact of this final rule on Indian tribes and determined that this rule will not have tribal implications that require consultation under E.O. 13175. AMS participates on teleconference with tribal leaders where matters of mutual interest regarding the marketing of agricultural products are discussed. Information about the changes to the assessment rate will be relayed through a notice to trade. AMS will work with the USDA, Office of Tribal Relations to ensure meaningful consultation is provided as needed with regards to the final rule.

This action was reviewed under the Regulatory Flexibility Act (5 United States Code (U.S.C.) 601 et seq. ) in the Order initially published in the September 5, 1986, issue of the Federal Register (51 FR 31898). The AMS Administrator determined at that time that the Order would not have significant economic impact on a substantial number of small entities; therefore, a regulatory impact analysis was not required. The Census of Agriculture reports that 64,871 U.S. farms produced hogs and pigs in 2017. Many of those farms are likely to be classified as small business by having total sales less than the $3.5 million threshold set by the Small Business Administration (SBA) definition (13 CFR 121.201). AMS does not believe that this rule change will have a significant or differential economic impact on small producers because total assessments paid are proportionate to the value of hogs sold by a producer.

This final rule decreases the rate of the assessment from 0.40 percent of the market value of porcine animals to 0.35 percent and decreases the amount of assessment per pound due on imported pork and pork products. While domestic assessments are only made to live porcine animals, assessments on imports are made to both live animal imports and post-slaughter pork and pork products. This update to the regulations updates assessments on the imported product based on the Harmonized Tariff Schedule (HTS) to bring the equivalent market value of live animals from which imported pork and pork products are derived in line with the market value of domestic porcine animals.

From 2018 to 2020, total checkoff revenue ranged from $72.3 million to $77.6 million. In that time, 95.6 percent of all revenue was from domestic sales and 4.4 percent was derived from assessments on imported hogs and pork products. Of domestic revenue, 98.6 percent was derived from market hogs and 1.4 percent was derived from feeder hogs. In 2021, total checkoff revenue increased approximately 41 percent to $103.6 million, an increase primarily reflecting the 47 percent increase in live hog prices. 1 Despite the price increase, both the share of all revenue derived from imports and the share of domestic revenue derived from live hogs was mostly unchanged in 2021 relative to previous years.

The assessment decrease reduces annual funding of the promotion, research, and consumer information program by an estimated $13.5 million under the assumption that 2021 market conditions persist. This decrease reflects both a $12.3 million reduction in domestic assessments stemming from the 12.5 percent decrease in the rate of assessment for live hogs ( i.e., the change from 0.40 to 0.35 percent assessment for live weight hogs), which totaled $98.4 million in 2021 and a $1.2 million reduction in importer assessments.

In 2021, the gross market value of all swine marketed in the United States was approximately $27 billion. The assessment decrease reflects the Delegate Body's desire to lessen the assessment burden on producers and make such funds available to pork producers and the industry. The expected benefit of the rule change is savings of $13.5 million in assessments that would have been paid under the existing rule. The expected cost of the rule is the potential loss of returns accruing to the industry from promotion, research, and consumer information programs paid for by the National Pork Board using assessment funds. While these programs have been shown to earn positive returns in academic studies when considering pre-2021 data, the sharp 2021 increase in assessment revenue is likely to create diminishing marginal returns to advertising. 2 However, even with the reduction in assessment rates, total program funds will have still increased significantly above 2020 levels owing to the ongoing increase in price levels, assuming the general market conditions of 2021 persist. For these reasons, the economic impact of the assessments is not expected to be a significant part of the total market value of swine. Accordingly, the AMS Administrator determined that this action will not have a significant economic impact on substantial number of small entities.

The information collection requirements have been previously approved by the OMB and have been assigned OMB control number 0581-0093. Reapproval for the information collection will not be necessary since the rate assessment does not substantially change the assessment collection process.

The Act (7 U.S.C. 4801-4819), enacted on December 23, 1985, authorized the establishment of a national pork promotion, research, and consumer information program. The final Order at 7 CFR part 1230 establishing a pork promotion, research, and consumer information program was published in the September 5, 1986, issue of the Federal Register (51 FR 31898; as corrected, at 51 FR 36383 and amended at 53 FR 1909, 53 FR 30243, 56 FR 4, 56 FR 51635, 60 FR 29962, 61 FR 28002, 62 FR 26205, 63 FR 45935, 64 FR 44643, 66 FR 67071, 67 FR 58320, and 69 FR 9924) and assessments began on November 1, 1986. The program was funded by an initial assessment rate of 0.25 percent of the market value of all porcine animals marketed in the United States and on imported porcine animals with an equivalent assessment on pork and pork products. However, that rate was increased to 0.35 percent effective December 1, 1991 (56 FR 51635) and to 0.45 percent effective September 3, 1995 (60 FR 29962). Further, the rate was decreased to 0.40 percent effective September 30, 2002 (67 FR 58320). The import assessments were decreased by five-hundredths to seven-hundredths of a cent per pound effective April 2, 2004, to reflect a decrease in the 2002 average price for domestic barrows and gilts (69 FR 9924). The total annual assessment rate collected in 2021 was $103.6 million. Assessments on imported pork and pork products accounted for about $4.5 million of the total.

The Order requires that producers pay to the National Pork Board an assessment of 0.40 percent of the market value of each porcine animal upon sale (7 CFR 1230.112). However, for purposes of collecting and remitting assessments, porcine animals are divided into three separate categories (1) feeder pigs, (2) slaughter hogs, and (3) breeding stock. Regulations under 7 CFR 1230.71 specifies that purchasers of feeder pigs, slaughter hogs, and breeding stock shall collect an assessment on these animals if assessments are due. Section 1230.71(b) of the Order further provides that for the purpose of collecting and remitting assessments persons engaged as a commission merchant, auction market, or livestock market in the business of receiving such porcine animals for sale on commission for or on behalf of a producer shall be deemed to be a purchaser.

Section 1230.110(a) requires importers of porcine animals to pay U.S. Customs Service (USCS), upon importation, the assessment of 0.40 percent of the porcine animal's declared value and importers of pork and pork products to pay USCS, upon importation, the assessment of 0.40 percent of the market value of the live porcine animals from which such pork and pork products were produced.

The Act and Order contain provisions for adjusting the rate of assessment. The Delegate Body has the responsibility to recommend the rate of assessment to the Department. The 2022 Delegate Body, at its annual meeting March 9-11, 2022, in Louisville, Kentucky, voted to recommend to the USDA the rate of assessment of 0.40 percent be decreased to 0.35 percent. In 2022, the Secretary appointed 155 members to serve on the Delegate Body, including 150 producers and 5 importers. At the Delegate Body annual meeting, 145 Delegates were present representing 101,017.5 valid share votes. There were 98,797.6 share votes cast following floor debate of the resolution for the rate assessment reduction. There were 93,151.3 share votes cast in favor of the 0.05 percent decrease in checkoff rate assessment. A simple majority of share votes is required to pass the resolution (7 CFR 1230.36). The assessment rate decrease also applies to the amount of assessment on imported pork and pork products pursuant to the 7 CFR 1230.110.

AMS weighed the costs and benefits of the change in pork assessment rates, acknowledging the role the Delegate Body plays in the disposition of funds and its insight into the effect of an assessment decrease. The cost of the assessment reduction is the reduced funds available for research, promotion and consumer information of pork and pork products and activities that strengthen and increase demand for lives hogs sold by producers paying the assessment. Economic research has shown that such research and promotion programs generally yield positive net returns to producers, a finding confirmed in the National Pork Board's own commissioned evaluation of the program based on data through 2020. While this finding would initially suggest that a reduction in the assessment would reduce returns to pork producers (and thus fails a cost benefit analysis test), AMS notes the sharp increase in pork prices in the intervening period as a mitigating factor to relying solely on that study.

Between 2018 and 2020, the national barrows and gilt national base live weight equivalent price for 51-51% lean hogs was $45.69 per cwt on a slaughter of 131.5 million head. In 2021, the price rose 47% to $67.29 per cwt while slaughter only fell 2 percent to 129.0 million head. Together, these changes have caused checkoff revenue to increase 41 percent between 2020 and 2021. While the reduced assessment will lower expected assessment revenue in future years from 2021, AMS still expects revenue to be greater than the 2018-2020 average in 2022 and in future years owing to the expected continuation of elevated prices.

In its assessments of the costs of the final rule, AMS assumed that demand for hogs and pork products is unchanged in the short run by any reduction in promotion expenditure that may result from the reduced assessment. As such, AMS finds there will be no cost to the final rule change in terms of reduced demand for pork. AMS notes that research and promotion spending is likely to exhibit diminishing marginal returns, meaning that the large increase in promotion expenditure from the 2021 increase in assessment revenue is unlikely to generate economic returns as those returns estimated from data in earlier periods, which started at a lower level. 3 AMS also notes that the National Pork Board, subject to the Secretary's approval, determines specifically how assessment revenue is spent to promote pork consumption and enhance demand. Subsequently, the National Pork Board is also likely to know the point at which the highest return promotional opportunities have been exhausted and that additional advertising becomes ineffective. Based on its independent analysis of market trends and the research on returns to the pork checkoff program, AMS agrees that this reduction in assessment rate will effectuate the purposes of the Act.

AMS notes that total assessment revenue is expected to remain above the 2020 level despite the assessment rate reduction. On this point, AMS calculated the total reduction in assessment revenue as the sum of the reduction in domestic and foreign revenue. Between 2018 and 2020, about 95.6 percent of assessment revenue was from domestic assessments on live hogs, most of which are market hogs although all types of hogs pay the same assessment rate. AMS estimated the reduction in domestic revenue of $12.3 by multiplying 2021 domestic revenue level of $97.3 million by the 12.5 percent reduction in the rate of assessment ( i.e., the change in the assessment rate from 0.4 to 0.35 dollars per hundred weight.)

AMS estimated the reduction in import assessment revenue using trade data available from the USDA Foreign Agricultural Service. This data shows that approximately 49 percent of assessment revenue from imports in 2021 was derived from live hog assessments, which, like domestic hogs, will see a 12.5 percent reduction in the rate of assessment. The remaining 51 percent of pork and processed pork products will see variable decreases in the rate of assessments, all of which are larger in magnitude than the 12.5 percent in the live hog rate. AMS calculated the average rate reduction for these pork and processed products to be 38.6 percent based on each product's average value share of imports between 2019 and 2021. AMS then calculated a change in the rate of all import assessments of 25.9 percent, calculated as the sum of the 49 percent revenue share for live hogs times the 12.5 assessment reduction plus the 51 percent revenue share for pork products times the 38.6 percent reduction. Applying the average rate of assessment to the $4.53 million in assessment revenue from imports in 2021, AMS found that import revenue will fall by $1.2 million.

The adjustment in importer assessments will bring the equivalent market value of live animals from which imported pork and pork products are derived in line with the market value of domestic porcine animals. Since the original rule was put in place, the wholesale-to-farm price spread for pork has increased from 38.7 percent in 2002 to 74 percent between 2019 and 2021, as report by the USDA Economic Research Service. Other things equal, a widening price spread will cause assessments on finished wholesale products to increase relative to hogs. This rule reduces the assessment rate for imported processed products by 38.6 percent on average but only 12.5 percent for live hogs.

This is not the first reduction in assessment rate for this program. As mentioned above, the program was funded by an initial assessment rate of 0.25 percent. The rate was increased to 0.35 percent effective December 1, 1991 (56 FR 51635) and then to 0.45 percent effective September 3, 1995 (60 FR 29962). Further, the rate was decreased to 0.40 percent effective September 30, 2002 (67 FR 58320). The import assessments were decreased by five-hundredths to seven-hundredths of a cent per pound effective April 2, 2004, to reflect a decrease in the 2002 average price for domestic barrows and gilts (69 FR 9924).

From 2012 to current, working off a comparable rate decrease, the Board has continued to build industry initiatives that have long-term return on investment impact for pork producers. Over the years, the Board has initiated several major projects that continue to add value to the industry regardless of budget such as building trust and adding value through a positive image of US Pork, establishing US Pork as the global leader in sustainability agriculture, preventing and preparing for foreign animal diseases, and strengthening state and industry partnerships to build support that keeps people, pigs and the planet as leading fundamentals. Even with the rate reduction, AMS has no reason to believe that the Board cannot effectively continue its goal to develop and expand markets for pork and pork products by funding promotion, research, and consumer information initiatives.

Further, over the past 10 years the National Pork Board has averaged producer checkoff revenue of $80.6 million. Even with an estimated $13.5 million ($12.3 million of that decrease deriving from reduced domestic assessments and $1.2 million deriving from reduced importer assessments) reduction in assessment revenue, the total assessment revenue will continue to fall above the last 10-year average assessment revenue.

AMS assumes that the reduction in promotional spending from the new rates will have a negligibly small effect on demand, especially given the still substantial increase in promotion spending above historic levels. For this reason, the costs of the rule will be small as well. The benefits of the rule, however, will be the direct saving to producers of $13.5 million in reduced assessment payments. Together, AMS assesses that the benefits to this rule change will exceed its costs.

The proposed rule describing the decrease in rate of assessment of market value of live porcine animals and assessment per pound due on imported pork and pork products was published on July 20, 2022, in the Federal Register (87 FR 43222). The 30-day public comment period closed on August 19, 2022. The Department received a total of 3 comments. Two comments did not support the rate decrease but instead recommended switching to plant-based farming or diet. The third comment was submitted by 27 state associations supporting the assessment rate decrease and encouraging the Final Rule be effective January 1, 2023, to allow appropriate time to adjust processes for collecting checkoff funds.

USDA carefully considered the comments and the recommendation of the Delegate Body and determined that a decrease in the assessment rate would effectuate the purposes of the Act. This action lessens the assessment burden on producers and importers. The effective date of January 1, 2023 gives the Board ample time to communicate this change and will not burden those that remit pork checkoff assessments. This final rule adopts the decrease in the assessment rate from 0.40 percent of market value of porcine animals to 0.35 percent as proposed and decreases the amount of assessment per pound due on imported pork and pork products.

For the reasons set forth in the preamble, the Agricultural Marketing Service amends 7 CFR part 1230 as follows:

Please refer to Docket ID NRC-2022-0144 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:

• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2022-0144. Address questions about NRC dockets to Dawn Forder, telephone: 301-415-3407, email: Dawn.Forder@nrc.gov. For technical questions contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to PDR.Resource@nrc.gov. For the convenience of the reader, instructions about obtaining materials referenced in this document are provided in the “Availability of Documents” section.

• NRC's PDR: You may examine and purchase copies of public documents, by appointment, at the NRC's PDR, Room P1 B35, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8:00 a.m. and 4:00 p.m. (ET), Monday through Friday, except Federal holidays.

Please include Docket ID NRC-2022-0144 in your comment submission. The NRC requests that you submit comments through the Federal rulemaking website at https://www.regulations.gov. If your material cannot be submitted using https://www.regulations.gov, call or email the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

This rule is limited to the changes contained in Amendment No. 10 to Certificate of Compliance No. 1031 and does not include other aspects of the NAC International, Inc. MAGNASTOR® Storage System design. The NRC is using the “direct final rule procedure” to issue this amendment because it represents a limited and routine change to an existing certificate of compliance that is expected to be non-controversial. Adequate protection of public health and safety continues to be reasonably assured. The amendment to the rule will become effective on January 18, 2023. However, if the NRC receives any significant adverse comment on this direct final rule by December 5, 2022, then the NRC will publish a document that withdraws this action and will subsequently address the comments received in a final rule as a response to the companion proposed rule published in the Proposed Rules section of this issue of the Federal Register , or as otherwise appropriate. In general, absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action.

A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

(1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

(a) The comment causes the NRC to reevaluate (or reconsider) its position or conduct additional analysis;

(b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

(c) The comment raises a relevant issue that was not previously addressed or considered by the NRC.

(2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

(3) The comment causes the NRC to make a change (other than editorial) to the rule, certificate of compliance, or technical specifications.

Section 218(a) of the Nuclear Waste Policy Act of 1982, as amended, requires that “[t]he Secretary [of the Department of Energy] shall establish a demonstration program, in cooperation with the private sector, for the dry storage of spent nuclear fuel at civilian nuclear power reactor sites, with the objective of establishing one or more technologies that the [Nuclear Regulatory] Commission may, by rule, approve for use at the sites of civilian nuclear power reactors without, to the maximum extent practicable, the need for additional site-specific approvals by the Commission.” Section 133 of the Nuclear Waste Policy Act states, in part, that “[t]he Commission shall, by rule, establish procedures for the licensing of any technology approved by the Commission under Section 219(a) [sic: 218(a)] for use at the site of any civilian nuclear power reactor.”

To implement this mandate, the Commission approved dry storage of spent nuclear fuel in NRC-approved casks under a general license by publishing a final rule that added a new subpart K in part 72 of title 10 of the Code of Federal Regulations (10 CFR) entitled “General License for Storage of Spent Fuel at Power Reactor Sites” (55 FR 29181; July 18, 1990). This rule also established a new subpart L in 10 CFR part 72 entitled “Approval of Spent Fuel Storage Casks,” which contains procedures and criteria for obtaining NRC approval of spent fuel storage cask designs. The NRC subsequently issued a final rule on November 21, 2008 (73 FR 70587), that approved the NAC International, Inc. MAGNASTOR® Storage System design and added it to the list of NRC-approved cask designs in § 72.214 as Certificate of Compliance No. 1031.

On December 9, 2019, NAC International, Inc. submitted a request to the NRC to amend Certificate of Compliance No. 1031. The NAC International, Inc. supplemented its request on the following dates: May 13, 2020, February 25, 2021, April 20, 2021, and September 2, 2021. Amendment No. 10 revises the certificate of compliance by adding a new metal storage overpack, which provides for additional structural strength and radiation shielding.

As documented in the preliminary safety evaluation report, the NRC performed a safety evaluation of the proposed certificate of compliance amendment request. The NRC determined that this amendment does not reflect a significant change in design or fabrication of the cask. Specifically, the NRC determined that the design of the cask would continue to maintain confinement, shielding, and criticality control in the event of each evaluated accident condition per § 72.236. In addition, any resulting occupational exposure or offsite dose rates from the implementation of Amendment No. 10 would remain well within the limits specified by 10 CFR part 20, “Standards for Protection Against Radiation.” Thus, the NRC found there will be no significant change in the types or amounts of any effluent released, no significant increase in the individual or cumulative radiation exposure, and no significant increase in the potential for or consequences from radiological accidents per § 72.236.

The NRC staff determined that the amended NAC International Inc. MAGNASTOR® Storage System cask design, when used under the conditions specified in the certificate of compliance, the technical specifications, and the NRC's regulations, will meet the requirements of 10 CFR part 72; therefore, adequate protection of public health and safety will continue to be reasonably assured. When this direct final rule becomes effective, persons who hold a general license under § 72.210 may, consistent with the license conditions under § 72.212, load spent nuclear fuel into NAC International, Inc. MAGNASTOR® Storage System casks that meet the criteria of Amendment No. 10 to Certificate of Compliance No. 1031.

The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this direct final rule, the NRC revises the NAC International, Inc. MAGNASTOR® Storage System design listed in § 72.214, “List of approved spent fuel storage casks.” This action does not constitute the establishment of a standard that contains generally applicable requirements.

Under the “Agreement State Program Policy Statement” approved by the Commission on October 2, 2017, and published in the Federal Register on October 18, 2017 (82 FR 48535), this rule is classified as Compatibility Category NRC—Areas of Exclusive NRC Regulatory Authority. The NRC program elements in this category are those that relate directly to areas of regulation reserved to the NRC by the Atomic Energy Act of 1954, as amended, or the provisions of 10 CFR chapter I. Therefore, compatibility is not required for program elements in this category. Although an Agreement State may not adopt program elements reserved to the NRC, and the Category “NRC” does not confer regulatory authority on the State, the State may wish to inform its licensees of certain requirements by means consistent with the particular State's administrative procedure laws.

The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31885).

Under the National Environmental Policy Act of 1969, as amended, and the NRC's regulations in 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions,” the NRC has determined that this direct final rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement is not required. The NRC has made a finding of no significant impact on the basis of the environmental assessment that follows.

The proposed action is to amend § 72.214 to revise the NAC International, Inc. MAGNASTOR® Storage System listing within the “List of approved spent fuel storage casks” to include Amendment No. 10 to Certificate of Compliance No. 1031.

This direct final rule amends the certificate of compliance for the NAC International, Inc. MAGNASTOR® Storage System design within the list of approved spent fuel storage casks to allow power reactor licensees to store spent fuel at reactor sites in casks with the approved modifications under a general license. Specifically, Amendment No. 10 revises the certificate of compliance to add a new metal storage overpack.

On July 18,1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent fuel under a general license in cask designs approved by the NRC. The potential environmental impact of using NRC-approved storage casks was analyzed in the environmental assessment for the 1990 final rule. The environmental assessment for this Amendment No. 10 tiers off of the environmental assessment for the July 18, 1990, final rule. Tiering on past environmental assessments is a standard process under the National Environmental Policy Act of 1969, as amended.

The NAC International, Inc. MAGNASTOR® Storage System is designed to mitigate the effects of design basis accidents that could occur during storage. Design basis accidents account for human-induced events and the most severe natural phenomena reported for the site and surrounding area. Postulated accidents analyzed for an independent spent fuel storage installation, the type of facility at which a holder of a power reactor operating license would store spent fuel in casks in accordance with 10 CFR part 72, can include tornado winds and tornado-generated missiles, a design basis earthquake, a design basis flood, an accidental cask drop, lightning effects, fire, explosions, and other incidents.

This amendment does not reflect a significant change in design or fabrication of the cask. Because there are no significant design or process changes, any resulting occupational exposure or offsite dose rates from the implementation of Amendment No. 10 would remain well within the 10 CFR part 20 limits. The NRC has also determined that the design of the cask as modified by this rule would maintain confinement, shielding, and criticality control in the event of an accident. Therefore, the proposed changes will not result in any radiological or non-radiological environmental impacts that significantly differ from the environmental impacts evaluated in the environmental assessment supporting the July 18, 1990, final rule. There will be no significant change in the types or significant revisions in the amounts of any effluent released, no significant increase in the individual or cumulative radiation exposures, and no significant increase in the potential for, or consequences from, radiological accidents. The NRC documented its safety findings in the preliminary safety evaluation report.

The alternative to this action is to deny approval of Amendment No. 10 and not issue the direct final rule. Consequently, any 10 CFR part 72 general licensee that seeks to load spent nuclear fuel into NAC International, Inc. MAGNASTOR® Storage System in accordance with the changes described in proposed Amendment No.10 would have to request an exemption from the requirements of §§ 72.212 and 72.214. Under this alternative, interested licensees would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee. The environmental impacts would be similar to the proposed action.

Approval of Amendment No. 10 to Certificate of Compliance No. 1031 would result in no irreversible commitment of resources.

No agencies or persons outside the NRC were contacted in connection with the preparation of this environmental assessment.

The environmental impacts of the action have been reviewed under the requirements in the National Environmental Policy Act of 1969, as amended, and the NRC's regulations in subpart A of 10 CFR part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions.” Based on the foregoing environmental assessment, the NRC concludes that this direct final rule, “List of Approved Spent Fuel Storage Casks: NAC International, Inc. MAGNASTOR® Storage System, Certificate of Compliance No. 1031, Amendment No. 10,” will not have a significant effect on the human environment. Therefore, the NRC has determined that an environmental impact statement is not necessary for this direct final rule.

This direct final rule does not contain any new or amended collections of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Existing collections of information were approved by the Office of Management and Budget, approval number 3150-0132.

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid Office of Management and Budget control number.

Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the NRC certifies that this direct final rule will not, if issued, have a significant economic impact on a substantial number of small entities. This direct final rule affects only nuclear power plant licensees and NAC International, Inc. These entities do not fall within the scope of the definition of small entities set forth in the Regulatory Flexibility Act or the size standards established by the NRC (§ 2.810).

On July 18, 1990 (55 FR 29181), the NRC issued an amendment to 10 CFR part 72 to provide for the storage of spent nuclear fuel under a general license in cask designs approved by the NRC. Any nuclear power reactor licensee can use NRC-approved cask designs to store spent nuclear fuel if (1) it notifies the NRC in advance; (2) the spent fuel is stored under the conditions specified in the cask's certificate of compliance; and (3) the conditions of the general license are met. A list of NRC-approved cask designs is contained in § 72.214. On November 21, 2008 (73 FR 70587), the NRC issued an amendment to 10 CFR part 72 that approved the NAC International, Inc. MAGNASTOR® Storage System design by adding it to the list of NRC-approved cask designs in § 72.214.

On December 9, 2019, and as supplemented on May 13, 2020, February 25, 2021, April 20, 2021, and September 2, 2021, NAC International, Inc. submitted a request to amend the MAGNASTOR® Storage System as described in Section IV, “Discussion of Changes,” of this document.

The alternative to this action is to withhold approval of Amendment No. 10 and to require any 10 CFR part 72 general licensee seeking to load spent nuclear fuel into the NAC International, Inc. MAGNASTOR® Storage System under the changes described in Amendment No. 10 to request an exemption from the requirements of §§ 72.212 and 72.214. Under this alternative, each interested 10 CFR part 72 licensee would have to prepare, and the NRC would have to review, a separate exemption request, thereby increasing the administrative burden upon the NRC and the costs to each licensee.

Approval of this direct final rule is consistent with previous NRC actions. Further, as documented in the preliminary safety evaluation report and environmental assessment, this direct final rule will have no adverse effect on public health and safety or the environment. This direct final rule has no significant identifiable impact or benefit on other government agencies. Based on this regulatory analysis, the NRC concludes that the requirements of this direct final rule are commensurate with the NRC's responsibilities for public health and safety and the common defense and security; therefore, this action is recommended.

The NRC has determined that the backfit rule (§ 72.62) does not apply to this direct final rule. Therefore, a backfit analysis is not required. This direct final rule revises Certificate of Compliance No. 1031 for the NAC International, Inc. MAGNASTOR® Storage System, as currently listed in § 72.214. The revision consists of the changes in Amendment No. 10 previously described, as set forth in the revised certificate of compliance and technical specifications.

Amendment No. 10 to Certificate of Compliance No. 1031 for the NAC International, Inc. MAGNASTOR® Storage System was initiated by NAC International, Inc. and was not submitted in response to new NRC requirements, or an NRC request for amendment. Amendment No. 10 applies only to new casks fabricated and used under Amendment No. 10. These changes do not affect existing users of the NAC International, Inc. MAGNASTOR® Storage System, and the current Amendment No. 9 continues to be effective for existing users. While current users of this storage system may comply with the new requirements in Amendment No. 10, this would be a voluntary decision on the part of current users.

For these reasons, Amendment No.10 to Certificate of Compliance No. 1031 does not constitute backfitting under § 72.62 or § 50.109(a)(1), or otherwise represent an inconsistency with the issue finality provisions applicable to combined licenses in 10 CFR part 52. Accordingly, the NRC has not prepared a backfit analysis for this rulemaking.

This direct final rule is not a rule as defined in the Congressional Review Act.

The documents identified in the following table are available to interested persons as indicated.

The NRC may post materials related to this document, including public comments, on the Federal rulemaking website at https://www.regulations.gov under Docket ID NRC-2022-0144. In addition, the Federal rulemaking website allows members of the public to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) navigate to the docket folder (NRC-2022-0144); (2) click the “Subscribe” link; and (3) enter an email address and click on the “Subscribe” link.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the following amendments to 10 CFR part 72:

In the Federal Register of October 11, 2022, in FR Doc. 2022-21354, on page 61232, in the first column, correct the RIN to read: RIN 2120-AL00.

The FAA published a final rule in the Federal Register (87 FR 65011; October 27, 2022), amending VOR Federal airways V-198, V-212, V-556, and V-558; amending RNAV route T-256; and establishing RNAV route T-466. Subsequent to publication, the FAA determined that the CHILD, TX, route point was inadvertently identified as a WP and the SEEDS, TX, route point was inadvertently identified as a Fix, in error. The correct route point references are the CHILD, TX, Fix and the SEEDS, TX, WP. This rule corrects those errors by changing the reference of the CHILD, TX, WP to the CHILD, TX, Fix; and the reference of the SEEDS, TX, Fix to the SEEDS, TX, WP.

These are editorial changes only to match the FAA NASR database information and do not alter the alignment of the affected T-466 route.

United States Area Navigation Routes are published in paragraph 6011 of FAA Order JO 7400.11G, dated August 19, 2022, and effective September 15, 2022, which is incorporated by reference in 14 CFR 71.1. The RNAV T-route listed in this document will be published subsequently in FAA Order JO 7400.11.

Accordingly, pursuant to the authority delegated to me, references to the CHILD, TX, WP and to the SEEDS, TX, Fix that are reflected in Docket No. FAA-2022-0436, as published in the Federal Register of October 27, 2022 (87 FR 65011), FR Doc. 2022-22164, are corrected as follows:

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. L. 108-214), the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), among other amendments, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (general controls and special controls), and class III (general controls and premarket approval).

Section 513(a)(1) of the FD&C Act defines the three classes of devices. Class I devices are those devices for which the general controls of the FD&C Act (controls authorized by or under sections 501, 502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h, 360i, or 360j) or any combination of such sections) are sufficient to provide reasonable assurance of safety and effectiveness; or those devices for which insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of safety and effectiveness or to establish special controls to provide such assurance, but because the devices are not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury, are to be regulated by general controls (section 513(a)(1)(A) of the FD&C Act). Class II devices are those devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness and for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions the Agency deems necessary to provide such assurance (section 513(a)(1)(B) of the FD&C Act). Class III devices are those devices for which insufficient information exists to determine that general controls and special controls would provide a reasonable assurance of safety and effectiveness, and are purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury (section 513(a)(1)(C) of the FD&C Act).

Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices) are automatically classified by section 513(f)(1) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until: (1) FDA reclassifies the device into class I or class II, or (2) FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. FDA determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act and part 807 (21 CFR part 807), subpart E, of the regulations.

A postamendments device that has been initially classified in class III under section 513(f)(1) of the FD&C Act may be reclassified into class I or II under section 513(f)(3) of the FD&C Act. Section 513(f)(3) of the FD&C Act provides that FDA, acting by administrative order, can reclassify the device into class I or class II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the proposed new class must have sufficient regulatory controls to provide a reasonable assurance of the safety and effectiveness of the device for its intended use.

In the Federal Register of November 24, 2021 (86 FR 66982), FDA published a proposed order to reclassify HIV viral load monitoring tests from class III to class II (special controls), subject to premarket notification. The comment period on the proposed order closed on January 24, 2022.

In response to the November 24, 2021, proposed order, FDA received three comments (two comments from public health organizations and one comment from a device manufacturer) by the close of the comment period, each containing one or more comments on one or more issues. We describe and respond to the comments in this section of the document. The order of response to the commenters is purely for organizational purposes and does not signify the comment's value or importance nor the order in which the comments were received.

(Comment 1) All three commenters expressed general support for the proposed reclassification and proposed special controls.

(Response 1) We acknowledge and appreciate the supportive comments. In this final order, we are reclassifying HIV viral load monitoring tests into class II and establishing the special controls published in the proposed order (86 FR 66982) without modifications except for minor editorial changes. See Section III, below, for a summary of the final order.

(Comment 2) One commenter requested that FDA provide more detail regarding the application in various analytical studies of the proposed requirement under § 866.3958(b)(2)(iii) (21 CFR 866.3958(b)(2)(iii)) that “[s]amples selected for use in analytical studies or used to prepare samples for use in analytical studies must be from subjects with clinically relevant genotypes circulating in the United States.”

(Response 2) FDA does not agree that additional detail is necessary to describe the requirement under § 866.3958(b)(2)(iii). The requirement to use or prepare samples from subjects with clinically relevant genotypes circulating in the United States is intended to ensure that the device will detect HIV genotypes that are of clinical concern at the time the device is cleared. How this requirement should be implemented for a particular analytical study would depend on other details regarding study design, the specific device at issue, and the currently circulating genotypes in the United States. Therefore, it is not practical to describe how this requirement would apply for all future analytical studies of HIV viral load monitoring tests in this final order. If the developer of an HIV viral load monitoring test seeks feedback about the design of an analytical study specific to the developer's device, such feedback can be provided through the Q-submission program. 1

(Comment 3) One commenter addressed proposed § 866.3958(b)(2)(v) and agreed with the requirement that “[s]amples tested to demonstrate analytical specificity must include appropriate numbers and types of samples from patients with underlying illness and infection. . . .” With respect to the requirement under proposed § 866.3958(b)(2)(v) that samples tested to demonstrate analytical specificity “include appropriate numbers and types of samples . . . from patients with potential interfering substances[,]” the commenter suggested that there be an option to test the effect of specific interfering substances “in accordance to [sic] CLSI EP07—Interference Testing in Clinical Chemistry; Ed 3. Approved Guideline.” The commenter added that, “[i]n this case both HIV-1 positive and HIV-1 negative specimens would be spiked with each potentially interfering substance (endogenous and exogenous) and tested in the investigational device.”

(Response 3) We agree with the comment that in some circumstances, a combination of clinical and spiked samples is appropriate based on the study goals and design, as discussed in EP07. The special control provision at § 866.3958(b)(2)(v) does not preclude this possibility. FDA believes that studies conducted to meet the requirements under § 866.3958(b)(2)(v) should use clinical samples to the extent possible because spiked samples may not mimic natural samples from individuals. We encourage device developers to consult the study designs and recommendations in the FDA recognized voluntary consensus standard EP07, Interference Testing in Clinical Chemistry, 3rd Ed. (see https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=37749 ).

(Comment 4) One commenter requested that FDA clarify the meaning of “production lots” in § 866.3958(b)(2)(iv), which requires that device verification and validation include a “[m]ultisite reproducibility study that includes the testing of three independent production lots.” Specifically, the commenter asked if “these [could] be premarket lots, which are equivalent to what would be commercialized”.

(Response 4) FDA believes the language in § 866.3958(b)(2)(iv) is sufficiently clear on this issue. The phrase “three independent production lots” means three lots of the finished device, where the lots are produced independently of each other. While the three independent lots may be produced in a premarket validation run, the devices must be manufactured by a process equivalent to that for the devices that will be commercialized.

(Comment 5) Two commenters recommended harmonizing reclassification of HIV viral load monitoring tests with the proposed reclassification of HIV diagnostic and supplemental tests and indicated that doing so could encourage development of or reduce barriers to marketing devices intended for use in both monitoring and diagnosis. Another comment recommended that FDA align the special controls for HIV tests with the requirements for HCV nucleic acid (NAT) tests in the final reclassification order “Microbiology Devices; Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, To Be Renamed Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests” (Docket No. FDA-2020-N-1088; April 2, 2020; 86 FR 66169).

(Response 5) Where appropriate, the special controls for HIV viral load monitoring tests in § 866.3958 are aligned with the special controls for HIV NAT diagnostic and/or supplemental tests in 21 CFR 866.3957, which were established in a final order published May 16, 2022 (Microbiology Devices: Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests, 87 FR 29661). However, although a test may use the same technology for two different intended uses, e.g., use of NAT tests as an aid in diagnosis of HIV infection and for viral load monitoring, the risks of a false negative result from a diagnostic test are not identical to and are potentially greater than the risks of a false negative result of a viral load test. For example, an individual living with HIV whose viral load is being monitored is under the care of a healthcare provider. In this instance, the risk of an incorrect result may be mitigated by clinical oversight. However, an individual undergoing diagnostic testing may have no signs or symptoms of infection, and one risk of an incorrect result is that they may be lost to care altogether. FDA is committed to working with manufacturers seeking clearance of a device for both intended uses using a least-burdensome approach. 2

With respect to the comment regarding alignment of special controls for HIV tests with those finalized for nucleic acid-based HCV ribonucleic acid (RNA) tests, we note that the special controls necessary to provide reasonable assurance of safety and effectiveness of an in vitro diagnostic device are based on, among other things, the specific analyte measured, the disease or condition for which the particular device is intended to be used in diagnosis, and the conditions of use. This means that the special controls may vary between devices that measure different analytes ( e.g., HIV and HCV) or with different conditions of use ( e.g., point of care versus lab-based) because the risks associated with each device are different. FDA has determined that the special controls identified in the proposed order are, together with general controls, sufficient to provide reasonable assurance of safety and effectiveness for HIV viral load monitoring tests. Therefore, FDA is finalizing those special controls in this order without making changes to align them further with those for nucleic acid-based HCV RNA tests.

To the extent the comment addresses alignment of special controls for HIV diagnostic and supplemental tests with those for nucleic acid-based HCV RNA tests, the comment is outside of the scope of this final order. For a discussion of comments received on FDA's proposed special controls for HIV NAT diagnostic and supplemental tests and HIV serological diagnostic and supplemental tests, please refer to the final order, “Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests” (Docket No. FDA-2019-N-5192; May 16, 2022; 87 FR 29661).

Based on the information discussed in the preamble to the proposed order (86 FR 66982), the comments received on the proposed order, and FDA's experience over the years with this device type, FDA concludes that special controls, in conjunction with general controls, will provide reasonable assurance of the safety and effectiveness of HIV viral load monitoring tests. FDA is adopting its findings under section 513(f)(3) of the FD&C Act, as published in the preamble to the proposed order.

FDA is issuing this final order to reclassify HIV viral load monitoring tests from class III into class II and to establish special controls that will be codified at § 866.3958. 3 In this final order, the Agency has identified special controls under section 513(a)(1)(B) of the FD&C Act which, together with general controls, provide a reasonable assurance of the safety and effectiveness of HIV viral load monitoring tests. FDA is reclassifying these devices and establishing special controls as published in the proposed order (86 FR 66982) with minor editorial changes for clarity in § 866.3958(a), (b)(1)(iii), and (b)(2)(vii).

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA has determined that premarket notification is necessary to provide a reasonable assurance of the safety and effectiveness of HIV viral load monitoring tests. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market HIV viral load monitoring tests must submit and obtain clearance of a premarket notification and demonstrate compliance with the special controls in this final order, prior to marketing the device.

The devices that are the subject of this reclassification are assigned the generic name “human immunodeficiency virus (HIV) viral load monitoring tests”. HIV viral load monitoring tests are identified as in vitro diagnostic prescription devices for the quantitation of the amount of HIV RNA in human body fluids. HIV viral load monitoring tests are intended for use in the clinical management of individuals living with HIV and are for professional use only. These devices are not intended for use as an aid in diagnosis or for screening donors of blood or blood products or human cells, tissues, or cellular and tissue-based products (HCT/Ps).

Under this final order, the HIV viral load monitoring tests are identified as prescription use only devices. As such, these prescription devices must satisfy prescription labeling requirements for in vitro diagnostic products (see 21 CFR 809.10(a)(4) and (b)(5)(ii)). A premarket notification submission for these devices will be required in the circumstances described in 21 CFR 807.81.

Under section 513(f)(3) of the FD&C Act, FDA may issue final orders to reclassify devices. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as newly codified orders. In accordance with section 513(f)(3) of the FD&C Act, we are codifying in this final order the classification of HIV viral load monitoring tests in the new § 866.3958, under which these devices are reclassified from class III to class II.

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.

FDA concludes that this final order contains no new collection of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required.

This final order refers to previously approved FDA collections of information. These collections of information are subject to review by the OMB under the PRA. 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 have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 803 have been approved under OMB control number 0910-0437; and the collections of information in 21 CFR parts 801 and 809 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:

In 2021, the United States Parole Commission issued an interim rule revising 28 CFR 2.34(a) (86 FR 51271, September 15, 2021). The comment period expired on November 15, 2021, and the Parole Commission did not receive any comments on the change. On October 13, 2022, the Parole Commission voted to

After the U.S. Parole Commission has granted a prisoner a parole effective date, but before the prisoner has signed the parole certificate, if the prisoner violates the rules of the institution, the Parole Commission may reopen the case and schedule a rescission hearing. 28 CFR 2.34(a). At that hearing, the Parole Commission may consider the report of the Bureau of Prisons (“BOP”) Disciplinary Hearing Officer (“DHO”) following a disciplinary hearing, that a prisoner has violated disciplinary rules as “conclusive evidence of institutional misconduct,” and does not need to conduct a full hearing to consider witnesses and evidence. 28 CFR 2.34(c). The disciplinary hearing conducted by the DHO complies with the procedural due process requirements established by the Supreme Court in Wolff v. McDonnell, i.e., the prisoner has notice of the alleged violations at least 24 hours in advance of hearing, a statement of factfinding, the right to call witnesses and present documentary evidence. Thus, the Parole Commission may rely on the findings and conclusions of the DHO to take action in response to the information.

For prisoners who are housed at a Residential Reentry Center (“RRC”) prior to their release and violate the rules, the in-person disciplinary hearing is conducted before the RRC's Center Disciplinary Committee (“CDC”). Under the BOP's Program Statement 7300.09, the CDC then refers its findings to the DHO for review, final action, and sanctions. Every court which has examined the procedures established by Program Statement 7300.09 has held that hearing procedures used by the CDC satisfy the procedural due process requirements established by the Supreme Court in Wolff v. McDonnell.

This rule permits the U.S. Parole Commission to rely on the CDC's findings to promote the smooth transition to the community or to return a prisoner who has demonstrated that he or she is not ready to be released to the community without requiring a second hearing by the DHO or a fully contested disciplinary hearing conducted by the U.S. Parole Commission.

The Parole Commission has added a phrase to clarify that parole may also be rescinded without a hearing for DC Code prisoners for up to 120 days. The interim rule only referenced the 90-day rescission of parole that pertains to US Code prisoners and the rule will apply correspondingly to US Code prisoner and DC Code prisoners under the Parole Commission's jurisdiction. The Parole Commission is publishing the revised rule at § 2.34(a) as a final rule without seeking public comment because this does not create a substantive change to parole decision-making.

This regulation has been drafted and reviewed in accordance with Executive Order 12866, “Regulation Planning and Review,” section 1(b), Principles of Regulation, and in accordance with Executive Order 13565, “Improving Regulation and Regulatory Review,” section 1(b), General Principles of Regulation. The Commission has determined that this rule is not a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review, and accordingly this rule has not been reviewed by the Office of Management and Budget.

This rule 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. Under Executive Order 13132, this rule does not have sufficient federalism implications requiring a federalism assessment.

This rule will not have a significant economic impact upon a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 605(b).

This rule will not cause State, local, or tribal governments, or the private sector, to spend $100,000,000 or more in any one year, and will not significantly or uniquely affect small governments. No action under the Unfunded Mandates Reform Act of 1995 is necessary.

This rule is not a “major rule” as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 Subtitle E—Congressional Review Act, now codified at 5 U.S.C. 804(2). This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on the ability of United States-based companies to compete with foreign-based companies. Moreover, this is a rule of agency practice or procedure that does not substantially affect the rights or obligations of non-agency parties, and does not come within the meaning of the term “rule” as used in Section 804(3)(C), now codified at 5 U.S.C. 804(3)(C). Therefore, the reporting requirement of 5 U.S.C. 801 does not apply.

Accordingly, the interim rule amending 28 CFR part 2 which was published at 86 FR 51271 on September 15, 2021, is adopted as final with the following change:

The Coast Guard will enforce the safety zone regulation for fireworks at The Wharf DC from 7 to 9 p.m. on December 3, 2022. This action is being taken to provide for the safety of life on navigable waterways during this event. Our regulation for Fireworks Displays within the Fifth Coast Guard District, 33 CFR 165.506, specifies the location of the safety zone for the fireworks show which encompasses portions of the Washington Channel in the Upper Potomac River as item 1 to table 2 to paragraph (h)(2). During the enforcement period, as reflected in § 165.506(d), if you are the operator of a vessel in the safety zone you 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 broadcasts.

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable The Coast Guard lacks sufficient time to provide for a comment period and then consider those comments before issuing the rule. It would be contrary to the public interest since the rule is needed by November 11, 2022 to ensure the safety of participants, spectators, the public, and vessels transiting the waters of Augusta, GA during the Head of the South Regatta.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable because immediate action is needed to respond to the potential safety hazards associated with a regatta of rowing vessels on the Savannah River near Augusta, GA.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port (COTP) Savannah has determined that potential hazards associated with a rowing regatta starting November 11, 2022, will be a safety concern for anyone on the Savannah River between mile markers 197 and 200. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the rowing regatta is underway.

This rule establishes a temporary safety zone from noon until 5 p.m. from November 11, 2022 through November 12, 2022. The safety zone will cover all navigable waters of the Savannah River near Augusta, GA between mile markers 197 and 200. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters during the rowing regatta. 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, and we discuss First Amendment rights of protestors.

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

This regulatory action determination is based on the rule being limited in duration, size, and scope. The temporary safety zone is limited in duration and size as it will be enforced for only 10 cumulative hours over the course of two consecutive days and will cover all navigable waters on the Savannah River between mile markers 197 and 200. The zone is limited in scope as vessels and persons and vessels may still enter, transit through, anchor in, or remain within the areas during the enforcement period if authorized by the COTP or a designated representative. The Coast Guard will provide notification of the regulated area to the local maritime community by Marine Safety Information Bulletin.

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 temporary safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a temporary safety zone lasting only 10 hours that will prohibit entry on the Savannah River between mile markers 197 and 200 near Augusta, GA. 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.

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

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

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 without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the event sponsor did not submit notice of the fireworks display to the Coast Guard with sufficient time remaining before the event to publish an NPRM. Delaying the effective date of this rule to wait for a comment period to run would be impracticable and contrary to the public interest by inhibiting the Coast Guard's ability to protect spectators and vessels from the hazards associated with this fireworks display.

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 . For the same reasons discussed in the preceding paragraph, waiting for a 30-day notice period to run would be impracticable and contrary to the public interest.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port (COTP) Buffalo has determined that fireworks over the water presents significant risks to public safety and property. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the fireworks display is taking place.

This rule establishes a safety zone from 5:30 through 7 p.m. on November 26, 2022. The safety zone will cover all navigable waters within a 420-foot diameter of land launched fireworks over the Oswego River, in Oswego, NY. The duration of the zone is intended to protect spectators, vessels, and the marine environment in these navigable waters during the fireworks display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP Buffalo or a designated representative.

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

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

This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. The safety zone will encompass a 420-foot diameter of land launched fireworks in the Oswego River, in Oswego, NY, lasting approximately 2 hours during the evening when vessel traffic is normally low. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting approximately 1.5 hours that will prohibit entry within a 420-foot diameter in the Oswego River, in Oswego, NY. for a fireworks display. 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.

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

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

I. General Information A. Does this action apply to me?

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2022-0505 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 January 3, 2023. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2022-0505, by one of the following methods.

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

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

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

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

In the Federal Register of August 30, 2022 (87 FR 52868) (FRL-9410-04-OCSPP), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-11671) filed by SciReg, Inc. (12733 Director's Loop, Woodbridge, VA 22192), on behalf of Eastman Chemical Company (P.O. Box 431, Kingsport, TN 37662). The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 1,3-benzenedicarboxylic acid, 5-sulfo-, sodium salt (1:1), polymer with 1,3-benzenedicarboxylic acid, 1,4-cyclohexanedimethanol and 2,2′-oxybis[ethanol] (CAS Reg. No. 54590-72-6), with a minimum number average molecular weight of 30,400 Daltons. That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. The Agency did not receive any public comments.

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

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

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information 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. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). 1,3-Benzenedicarboxylic acid, 5-sulfo-, sodium salt (1:1), polymer with 1,3-benzenedicarboxylic acid, 1,4-cyclohexanedimethanol and 2,2′-oxybis[ethanol], with a minimum number average molecular weight 30,400 Daltons, conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.

In FR Doc. 2022-48780 of August 10, 2022 (87 FR 48780), there were a number of technical and typographical errors that are identified and corrected in this final rule correction and correcting amendment. The final rule corrections and correcting amendment are applicable to discharges occurring on or after October 1, 2022, as if they had been included in the document that appeared in the August 10, 2022 Federal Register .

On pages 48781, 48785, and 49313, we made typographical and technical errors in specifying certain fiscal years.

On pages 49195, 49197, 49207, 49217, 49223, 49229, 49263, 49267, and 49311, we made typographical errors in referencing a statutory citation.

On page 48789, in the table of the summary of costs and benefits of certain major provisions, we are making conforming corrections to the estimates discussed in the “Update to the IPPS Payment Rates and Other Payment Policies” row resulting from the correction to the maximum new technology add-on payment for cases involving the use of Defencath TM discussed later in this section of this final rule correction and correcting amendment.

On page 48790, in the table of the summary of costs and benefits of certain major provisions, we are making corrections to the description of the estimates discussed for the Hospital-Acquired Condition Program.

On pages 48790, 49308, 49327, 49335, 49377, and 49398, we made technical and typographical errors in Federal Register citations and cross-references.

On pages 48981 through 48982, in our discussion of new medical services and technologies, we are correcting the cost per case and maximum new technology add-on payment for a case involving the use of Defencath TM .

On page 49071, we made typographical errors and an omission in our discussion of revisions to Worksheet E-4 of the hospital cost report instructions.

On page 49087, we made and are correcting a typographical error in our discussion of the Hospital Readmission Reduction Program.

On pages 49095, 49106, 49129, 49248, 49266, 49283, and 49295, we made and are correcting typographical errors in several footnotes and footnote references.

On pages 49201, 49230, 49232, 49233, 49297, and 49308, in the discussion of the Hospital Inpatient Quality Reporting (IQR) Program, we are correcting inadvertent omissions as well as typographical and technical errors.

On pages 49315, 49317, and 49318, in the discussion of the Long-term Care Hospital Quality Reporting Program (LTCH QRP) we are correcting several technical and typographical errors.

On pages 49347 and 49362, in the discussion of the Medicare Promoting Interoperability Program, we made and are correcting typographical and technical errors.

On page 49410, we inadvertently made a typographical error in the paragraph numbering for a paragraph in § 482.42(f)(2).

As discussed further in section II.D. of this final rule correction and correcting amendment, we made updates to the calculation of Factor 3 of the uncompensated care payment methodology to reflect updated information on hospital mergers received in response to the final rule and made corrections for report upload errors and an update to the DSH eligibility for one provider that was inadvertently projected not DSH eligible in the final rule. Based on the March 2022 Provider Specific File's Medicaid fraction and the FY 2020 SSI fractions, this provider is projected DSH eligible for purposes of interim uncompensated care payments during FY 2023. Specifically, there were two merger updates, one update on a report upload discrepancy, and one update on DSH eligibility projection. We recalculated the total uncompensated care amount for all DSH-eligible hospitals to reflect these updates. In addition, because the Factor 3 for each hospital reflects that hospital's uncompensated care amount relative to the uncompensated care amount for all DSH hospitals, we also recalculated Factor 3 for all DSH-eligible hospitals. The hospital-specific Factor 3 determines the total amount of the uncompensated care payment a hospital is eligible to receive for a fiscal year. This hospital-specific payment amount is then used to calculate the amount of the interim uncompensated care payments a hospital receives per discharge. Given the small number of updates to the information used in the calculation of Factor 3, the change to the previously calculated Factor 3 for the majority of hospitals is of limited magnitude.

We note that the fixed-loss cost threshold was unchanged after these Factor 3 recalculations. (As discussed elsewhere, however, we incorporated the revised uncompensated care payment amounts into our recalculation of the FY 2023 fixed-loss threshold and related figures to reflect the use of supplemental outlier reconciliation data.) We further note that while for certain prior years, we have also recalculated the budget neutrality factors to reflect revisions to the calculation of Factor 3, in combination with the correction of other errors, given the limited magnitude of the changes to uncompensated care payments, and because we are not making corrections to any other components of the calculation of these budget neutrality factors for FY 2023, we did not recalculate any budget neutrality factors due to the changes to Factor 3.

On pages 49420 through 49421 and 49427 through 49428, we are revising the calculation of the percentage of operating outlier reconciliation dollars to total Federal operating payments based on the FY 2017 cost reports, which is used in our projection of operating outlier reconciliation payments for the FY 2023 outlier threshold calculation, to reflect the use of supplemental outlier reconciliation data, as discussed in the FY 2023 IPPS/LTCH PPS final rule, including additional supplemental data from some hospitals that had an outlier reconciliation amount recorded on Worksheet E, Part A, Line 2.01. In addition to revising the percentage of operating outlier reconciliation dollars to total Federal operating payments, we are also revising the percentage of capital outlier payments to total capital Federal payments for FY 2017 to reflect these additional supplemental data for hospitals that had an outlier reconciliation amount recorded on Worksheet E, Part A, Line 93, Column 1. Accordingly, under our established methodology, this correction to the percentage of operating outlier reconciliation dollars to total Federal operating payments results in a change in the targeted operating outlier percentage and the FY 2023 outlier threshold. In addition, under our established methodology, the correction to the percentage of capital outlier payments to total capital Federal payments and the change in the FY 2023 outlier threshold results in a change in the estimated capital outlier percentage. We note that these recalculations also reflect the revisions to Factor 3 of the uncompensated care payment methodology described previously.

On pages 49433 through 49437, in our discussion of the determination of the Federal hospital inpatient capital related prospective payment rate update, due to the correction of the combination of errors listed previously (the revisions to Factor 3 of the uncompensated care payment methodology, and, in particular, the corrections to the outlier reconciliation projections and outlier threshold), we have made conforming corrections to the capital outlier adjustment, capital Federal rate and related figures. On page 49453, we are also making conforming corrections to the capital standard Federal payment rate in Table 1D.

On page 49438, we made a typographical error in referencing a statutory citation.

In addition, on page 49450, we are making conforming changes to the fixed-loss amount for FY 2023 site neutral payment rate discharges, and the high cost outlier threshold (based on the corrections to the IPPS outlier threshold (that is, fixed-loss amount) discussed previously).

We are correcting the errors in the following IPPS table that is listed on page 49453 of the FY 2023 IPPS/LTCH PPS final rule and is available on the internet on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/index.html. The tables that are available on the internet have been updated to reflect the revisions discussed in this final rule correction and correcting amendment.

Table 18—FY 2023 Medicare DSH Uncompensated Care Payment Factor 3. For the FY 2023 IPPS/LTCH PPS final rule, we published a list of hospitals that we identified to be subsection (d) hospitals and subsection (d) Puerto Rico hospitals projected to be eligible to receive interim uncompensated care payments for FY 2023. As stated in the FY 2023 IPPS/LTCH PPS final rule (87 FR 49046) we allowed the public an additional period after the issuance of the final rule to review and submit via email any updated information on mergers and/or to report upload discrepancies. We are updating this table to reflect the information on mergers, upload discrepancy, and DSH eligibility received in response to the final rule and to revise the Factor 3 calculations for purposes of determining uncompensated care payments for the FY 2023 IPPS/LTCH PPS final rule. We are revising Factor 3 for all hospitals to reflect the updated merger information, upload discrepancy information, and DSH eligibility information received in response to the final rule. We are also revising the amount of the total uncompensated care payment calculated for each DSH eligible hospital. The total uncompensated care payment that a hospital receives is used to calculate the amount of the interim uncompensated care payments the hospital receives per discharge. As previously discussed, given the limited magnitude of these uncompensated care payment corrections, and because we are not making corrections to any other components of the calculation of the budget neutrality factors for FY 2023, we do not believe the revisions to the uncompensated care payment amounts merit recalculating all budget neutrality factors. However, the revised uncompensated care payment amounts were incorporated into our recalculation of the outlier fixed-loss cost threshold and related figures to reflect the corrections to the outlier reconciliation projections used in the FY 2023 outlier threshold calculation, as described previously.

On pages 49457, 49494, and 49495 we are making conforming corrections to the estimated overall impact, estimated overall change in new technology add-on payments, and the accounting statement and table for acute care hospitals under the IPPS, resulting from the correction to the maximum new technology add-on payment for cases involving the use of Defencath TM discussed in section II.A. of this final rule correction and correcting amendment.

On pages 49461 through 49463, 49467 through 49468, and 49482 through 49485 in our regulatory impact analyses, we have made conforming corrections to certain factors, values, tables and accompanying discussion of the changes in operating and capital IPPS payments for FY 2023 as a result of the technical errors that lead to changes in our calculation of the outlier threshold and capital Federal rate (as discussed in section II.B. of this final rule correction and correcting amendment). These conforming corrections include changes to the following:

• On pages 49461 through 49463, the table titled “Table I—Impact Analysis of Changes to the IPPS for Operating Costs for FY 2023”.

• On pages 49467 through 49468, the table titled “Table II—Impact Analysis of Changes for FY 2023 Acute Care Hospital Operating Prospective Payment System (Payments per discharge)”.

• On pages 49484 and 49485, the table titled “TABLE III.—COMPARISON OF TOTAL PAYMENTS PER CASE [FY 2022 PAYMENTS COMPARED TO FY 2023 PAYMENTS]”.

On pages 49469 through 49470, we are correcting values in tables and estimated total payment values in accompanying discussion resulting from the correction to the maximum new technology add-on payment for cases involving the use of Defencath TM .

On page 49470, under the table displaying the FY 2023 Estimates for New Technology Add-On Payments for FY 2023, we are correcting the inadvertent omission of the heading for the next section.

On pages 49471 through 49474 we are correcting the discussion of the “2. Effects of Changes to Medicare DSH and Uncompensated Care Payments for FY 2023 and the New Supplemental Payment for Indian Health Service Hospitals and Tribal Hospitals and Hospitals Located in Puerto Rico” for purposes of the Regulatory Impact Analysis in Appendix A of the FY 2023 IPPS/LTCH PPS final rule, including the table titled “Modeled Uncompensated Care Payments* and Supplemental Payments for Estimated FY 2023 DSHs by Hospital Type*” on pages 49472 and 49473, in light of the corrections discussed in section II.D. of this final rule correction and correcting amendment.

Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rulemaking in the Federal Register before the provisions of a rule take effect. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of the proposed rulemaking in the Federal Register and provide a period of not less than 60 days for public comment. 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 provide exceptions from the notice and 60-day comment period and delay in effective date requirements of the Act as well. 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 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. This document corrects technical and typographical errors in the preamble, regulations text, addendum, payment rates, tables, and appendices included or referenced in the FY 2023 IPPS/LTCH PPS final rule, but does not make substantive changes to the policies or payment methodologies that were adopted in the final rule. As a result, this correcting document is intended to ensure that the information in the FY 2023 IPPS/LTCH PPS final rule accurately reflects the policies adopted in that document.

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 corrections in this document into the final rule or delaying the effective date would be contrary to the public interest because it is in the public's interest for providers to receive appropriate payments in as timely a manner as possible, and to ensure that the FY 2023 IPPS/LTCH PPS final rule accurately reflects our policies. Furthermore, such procedures would be unnecessary, as we are not altering our payment methodologies or policies, but rather, we are simply implementing correctly the methodologies and policies that we previously proposed, requested comment on, and subsequently finalized. This correcting document is intended solely to ensure that the FY 2023 IPPS/LTCH PPS final rule accurately reflects these payment methodologies and policies. Therefore, we believe we have good cause to waive the notice and comment and effective date requirements. Moreover, even if these corrections were considered to be retroactive rulemaking, they would be authorized under section 1871(e)(1)(A)(ii) of the Act, which permits the Secretary to issue a rule for the Medicare program with retroactive effect if the failure to do so would be contrary to the public interest. As we have explained previously, we believe it would be contrary to the public interest not to implement the corrections in this final rule correction for discharges occurring on or after October 1, 2022, because it is in the public's interest for providers to receive appropriate payments in as timely a manner as possible, and to ensure that the FY 2023 IPPS/LTCH PPS final rule accurately reflects our policies.

In FR Doc. 2022-16472 of August 10, 2022 (87 FR 48780), we are making the following corrections:

1. On page 48781, first column,

a. Lines 23 and 24, the phrase “S-3 Wage Data for the FY 2022 Wage Index” is corrected to read “S-3 Wage Data for the FY 2023 Wage Index”.

b. Lines 27 and 28, the phrase, “Computing the FY 2022 Unadjusted Wage Index” is corrected to read “Computing the FY 2023 Unadjusted Wage Index”.

c. Line 74, the phrase ” Updates for FY 2022 (§ 412.64(d))” is corrected to read “Updates for FY 2023 (§ 412.64(d))”.

2. On page 48785, second column, third paragraph, the phrase “FY 2024” is corrected to read “FY 2023”.

3. On page 48789, in the untitled table, second column (Description of Costs, Transfers, Savings, and Benefits), third row (Update to the IPPS Payment Rates and Other Payment Policies),

a. Line 2, the figure “$1.4 billion” is corrected to read “$1.5 billion”.

b. Line 4, the figure “$1.0 billion” is corrected to read “$0.9 billion”.

4. On page 48790, in the untitled table,

a. Second column (Description of Costs, Transfers, Savings, and Benefits),

(1) First row, lines 3 and 4, the phrase, “specific HSRs and a 30-day preview period for the NHSN CDC HAI measures.” is corrected to read “specific HSRs and a 30-day preview period.”.

(2) Last row, line 1, the reference, “section XII.B.10.” is corrected to read “section XII.B.11.”

b. Following the table (Table Note 1), the sentence beginning with the phrase “ 1 For the purpose” and ending with the phrase “and CABG).” is corrected by removing the sentence.

5. On page 48981,

a. First column, fourth full paragraph, lines 14 and 15, the phrase “$5,850 to the hospital, per patient” is corrected to read “$1,950 per 5mL vial. “

b. Third column, last partial paragraph, lines 2 and 3, the language “the cost per case of the DefenCath TM is $5,850” is corrected to read “the cost of DefenCath TM is $1,950 per vial. Per the applicant, the average utilization of DefenCath TM is 9.75 vials per patient, resulting in an average cost per case of $19,012.50.”

6. On page 48982, first column, first partial paragraph, line 5, the figure “$4,387.50” is corrected to read “$14,259.38”.

7. On page 49071,

a. Second column, last partial paragraph,

(1) Line 15, the phrase “line 9 minus line 8” is corrected to read “line 8 minus line 9”.

(2) Lines 18 and 19, the phrase “line 9 minus line 8” is corrected to read “line 8 minus line 9”.

(3) Lines 19 and 20, the phrase “line 9 minus line 8” is corrected to read “line 8 minus line 9”.

b. Third column, first partial paragraph, lines 1 and 2, the phrase “minus line 8 on line 20,' but we believe they meant to say `on line 22').” is corrected to read “minus line 8' but we believe they meant to state `line 8 minus line 9.' We also note that the commenters indicated to enter the result `on line 20,' but we believe they meant to state `on line 22').”.

8. On page 49087, second column, third full paragraph, line 13, the phrase “COVID-10 specific ICD-10” is corrected to read “COVID-19 specific ICD-10”.

9. On page 49095, first column, third footnote paragraph (footnote 232), the parenthetical web address, “(statnews.com)” is corrected to read “ https://www.statnews.com/2021/09/20/covid-19-set-to-overtake-1918-spanish-flu-as-deadliest-disease-in-american-history/ ”.

10. On page 49106,

a. First column, first paragraph (footnote 275), lines 3 through 5, the phrase, “Fleisher et al. (2022). New England Journal of Medicine. Article available here:” is corrected to read “Fleisher et al. (2022). Health Care Safety During the Pandemic and Beyond—Building a System That Ensures Resilience. New England Journal of Medicine. Available at:”

b. Second column—

(1) Sixth footnote paragraph (footnote 283), lines 4 through 10, the hyperlink, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-oral-antiviral-treatment-covid-19-certain#:~:text=Today%2C%20the%20U.S.%20Food%20and,progression%20to%20severe%20COVID%2D19%2C is corrected to read: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-oral-antiviral-treatment-covid-19-certain

(2) Eighth footnote paragraph (footnote 285), lines 3 through 7, the hyperlink, “ https://www.washingtonpost.com/politics/biden-to-give-away-400-million-n95-masks-starting-next-week/2022/01/19/5095c050-;7915-11ec-9dce-7313579de434_story.html ” is corrected to read “ https://www.washingtonpost.com/kidspost/2022/01/19/biden-give-away-400-million-n95-masks/ ”.

11. On page 49129, first column, footnote paragraph (Footnote 314), line 5 and 6, the hyperlink “ https://oig.hhs.govAd/oei/reports/OEI-06-18-00400.asp ” is corrected to read https://oig.hhs.gov/oei/reports/OEI-06-18-00400.asp.

12. On page 49195, third column, first full paragraph, lines 3 and 4, the reference “section 1866” is corrected to read “section 1886”.

13. On page 49197, second column, third full paragraph, lines 11 and 12, the reference “section 1866” is corrected to read “section 1886”.

14. On page 49201, first column, second full paragraph, lines 11 through 17, the sentence “First, because social risk factors disproportionately impact historically 481 ” is corrected to read “First, because social risk factors disproportionately impact underserved communities, promoting screening for these factors could serve as evidence-based building blocks for supporting hospitals and health systems in actualizing commitment to address disparities, improve health equity through addressing the social needs with community partners, and implement associated equity measures to track progress.”.

15. On page 49207, first column, second full paragraph, lines 3 and 4, the reference “section 1866” is corrected to read “section 1886”.

16. On page 49217, first column, second full paragraph, line 3, the reference “section 1866” is corrected to read “section 1886”.

17. On page 49223, second column, first full paragraph, lines 7 and 8, the reference “section 1866” is corrected to read “section 1886”.

18. On page 49229, first column, first full paragraph, lines 4 and 5, the reference “section 1866” is corrected to read “section 1886”.

19. On page 49230, top third of the page, second column, second full paragraph, lines 2 through 6, the sentence “The measure is designed to be calculated by the hospitals' CEHRT using the patient-level data and then submitted by hospitals to CMS.” is corrected to read “Patient-level data is to be submitted to CMS where risk-adjustment and measure calculation will occur.”.

20. On page 49232, lower two-thirds of the page, first column, last full paragraph, lines 5 and 6, the phrase “an additional hospital unaffiliated with the first 25” is corrected to read ” an additional 5 hospitals unaffiliated with the first 25”.

21. On page 49233, third column, first full paragraph, lines 1 through 5, the sentence “We reiterate that this is an eCQM in which the data is collected through hospitals' EHR and designed to be calculated by the hospital's CEHRT (87 FR 28513).” is corrected to read “We reiterate that this is an eCQM in which the data is collected through hospitals' EHR (87 FR 28514). The measure is designed for patient-level data to be submitted to CMS where risk-adjustment and measure calculation will occur.”.

22. On page 49248, first column, 10th footnote paragraph (Footnote 919), lines 1 and 2, the phrase, “Ma kela K.T., Peltola M., Sund R, Malmivaara A., Ha kkinen U., Remes V.” is corrected to read “Mäkelä K.T., Peltola M., Sund R., Malmivaara A., Häkkinen U., Remes V.”.

23. On page 49263, third column, second full paragraph, lines 5 and 6, the reference “section 1866” is corrected to read “section 1886”.

24. On page 49266, third column, before the first footnote paragraph (Footnote 981), the footnote paragraphs are corrected by adding a footnote (Footnote 980) to read as follows:

“National Quality Forum. Surgery Fall Cycle 2020. Measure Testing (subcriteria 2a2, 2b1-2b6) Document. November 3, 2020. Available at: https:// nqfappservicesstorage.blob.core.windows.net/proddocs/22/Fall/2020/measures/1550/shared/1550.zip. ”.

25. On page 49267, third column, second full paragraph, lines 4 and 5, the reference “section 1866” is corrected to read “section 1886”.

26. On page 49283, first column, sixth footnote paragraph (footnote 1021), lines 6 and 7, the hyperlink “ https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2787181 ” is corrected to read “ https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2787184 ”.

27. On page 49295, second column, first partial footnote paragraph (footnote 1074), lines 1 through 4, the hyperlink “Accessed on Available at: https://arpsp.cdc.gov/profile/infections/clabsi?year-select-report=year2019&year-select-hai-state-list=year2019 ” is corrected to read “Accessed July 27, 2021. Available at: https://arpsp.cdc.gov/profile/nhsn/clabsi. ”

28. On page 49297, second column, first full paragraph, lines 17 and 18, the phrase “increase the risk of developing CDIs. ” is corrected to read “increase the risk of contracting HAIs.”.

29. On page 49308, second column, last partial paragraph, line 18, the citation (85 FR 58952 through 58944)” is corrected read “(85 FR 58942 through 58953)”.

30. On page 49311, first column, first full paragraph, line 3, the reference “section 1866” is corrected to read “section 1886”.

31. On page 49312, first column, last partial paragraph, line 1, the reference “section 1866” is corrected to read “section 1886”.

32. On page 49313, third column, third full paragraph, line 7, the phrase “FY 2021 confidential” is corrected to read “FY 2022 confidential”.

33. On page 49315, middle of the page, in the table titled “Table IX.G.-01. Quality Measures Currently Adopted for the FY 2023 LTCH QRP”, the entries in rows 3 and 4 are corrected to read as follows:

34. On page 49317, first column, fifth paragraph, lines 10 and 11, the phrase, “This commenter also suggested CMS to work with CMS to determine” is corrected to read “This commenter also suggested CMS determine”.

35. On page 49318—

a. Second column, third full paragraph, line 1, the phrase, “A number of commenters provider” is corrected to read “A number of commenters provided”.

b. Third column, first full paragraph, lines 36 through 40, the sentence, “We also received one comment recommending CMS use a combination of peer group benchmarking and statistical significance. ” is corrected read “A commenter also suggested additional guiding principles.”

36. On page 49327, third column, first partial paragraph, line 3, the reference “[TABLE XX]” is corrected to read “Table IX.H.-07”.

37. On page 49335, third column, second full paragraph, line 14, the citation “(87 FR 28586 through 28587)” is corrected to read “(87 FR 28585 through 28587)”.

38. On page 49347, third column, first partial paragraph, line 15, the phrase, “We finalized our proposal” should read “We are finalizing our proposal”.

39. On page 49362, second column, first partial paragraph, lines 11 through 15, the sentence “Testing established the feasibility of the measure, first in 25 hospitals across eight healthcare sites and then in additional hospital unaffiliated with the first 25.” is corrected to read “The measure developer's testing established the feasibility of the measure, first in 25 hospitals across 8 healthcare sites and then in an additional 5 hospitals unaffiliated with the first 25, and across several different electronic health record systems.”.

40. On page 49377, third column, first partial paragraph, lines 31 and 32, the reference “sections XII.B.10. and XII.H.11, ” is corrected to read “sections XII.B.11. of the preamble and I.H.11. of the Appendix,”.

41. On page 49398, second column, first full paragraph, lines 1 and 2, the reference, “section XX.B.2.” is corrected to read “section X.B.2.”.

1. On page 49420, first column, second full paragraph,

a. Line 24, the phrase “2 additional” is corrected to “8 additional”.

b. Line 32, the phrase “2 hospitals' ” is corrected to “8 hospitals' ” .

c. Line 40, the phrase “2 additional” is corrected to “8 additional”.

d. Lines 42 and 43, the phrase “2 hospitals, a total of 17 hospitals” is corrected to read as follows “8 hospitals, a total of 23 hospitals”.

e. Line 47, the phrase “negative $17,153,313 (Step 2)” is corrected to read as follows “negative $25,475,549 (Step 2)”.

f. Line 50, the phrase, “2 hospitals is $88,414,357,653 (Step 3)” is corrected to read as follows “8 hospitals is $88,407,788,794 (Step 3)”.

g. Lines 51 and 52, the phrase “negative 0.019401 percent” is corrected to read “negative 0.028816 percent”.

h. Line 53, the phrase “negative 0.02 percent” is corrected to read “negative 0.03 percent”.

i. Lines 57 and 58, “5.12 percent [5.1 percent−(− 0.02 percent)]” is corrected to read “5.13 percent [5.1 percent−(− 0.03 percent)]”.

2. On page 49421,

a. Second column,

(1) First partial paragraph, lines 4 and 5, the phrase “supplemented for 2 hospitals for a total of 14 hospitals,” is corrected to read “supplemented for 8 hospitals for a total of 20 hospitals,”.

(2) First full paragraph,

(a) Lines 2 and 3, the phrase “2 hospitals, 14 hospitals” is corrected to read “8 hospitals, 20 hospitals”.

(b) Line 6, the figure “$1,101,225” is corrected to read “$2,556,541”.

(c) Line 9, the figure “$7,995,731,783” is corrected to read “$7,994,424,546”.

(d) Line 10, the figure, “0.013773” is corrected to read “0.031979”.

(e) Line 11, the figure, “0.01” is corrected to read “0.03”.

(f) Line 17, the figure “0.01” is corrected to read “0.03”.

(g) Line 20, the figure “0.01” is corrected to read “0.03”.

b. Third column, last full paragraph,

(1) Line 2, the figure “5.66 percent” is corrected to read “5.67 percent”.

(2) Line 4, the phrase “$406,733,862 divided by $7,190,928,057” is corrected to read “$407,648,341 divided by “$7,190,718,976”.

(3) Line 6, the figure “$406,733,862” is corrected to read “$407,648,341”.

(4) Line 7, the figure “$6,784,194,195” is corrected to read “$6,783,070,635”.

(5) Line 11, the figure “5.40 percent” is corrected to read “5.41 percent”.

(6) Line 12, the figure “$346,066,050” is corrected to read “$346,855,738”.

(7) Line 13, the figure “$6,412,816,596” is corrected to read “$6,412,729,550”.

(8) Line 14, the figure “$346,066,050” is corrected to read “$346,855,738”.

(9) Line 16, the figure “$6,066,750,547” is corrected to read “$6,065,873,812”.

(10) Line 20, the figure “5.53 percent” is corrected to read “5.54 percent”.

(11) Line 26, the figure “0.01 percent” is corrected to read “0.03 percent”.

(12) Line 30, the figure “5.53 percent” is corrected to read “5.54 percent”.

(13) Lines 34 and 35, the equation “5.52 percent (5.53 percent−0.01 percent)” is corrected to read 5.51 percent (5.54 percent−0.03 percent)”.

3. On page 49427, third column, second full paragraph, line 31, the figure “5.12” is corrected to “5.13”.

4. On page 49428,

a. Top of the page,

(1) First column,

(a) First partial paragraph,

(i) Lines 3 through 5, the phrase “0.019401 percent, which when rounded to the second digit, is 0.02 percent” is corrected to “0.028816 percent, which when rounded to the second digit, is 0.03 percent”

(ii) Lines 8 and 9, the mathematical expression “5.12 percent [5.1 percent−(0.02 percent)]” is corrected to read “5.13 percent [5.1 percent−(−0.03 percent)]”.

(b) Third full paragraph,

(i) Line 4, the figure “$39,389” is corrected to read “$39,317”.

(ii) Line 6, the figure “$4,658,400,549” is corrected to read “$4,667,954,052”.

(iii) Line 7, the figure “$86,325,462,972” is corrected to read “$86,324,951,579”.

(iv) Line 11, the figure “5.12” is corrected to read “5.13”.

(c) Second partial paragraph, line 2, the figure “$38,328” is corrected to read “$38,259”.

(2) Second column,

(a) First partial paragraph,

(i) Line 2, the figure “$4,073,729,554” is corrected to read “$4,081,975,259”

(ii) Line 3, “$75,488,568,943” is corrected to “$75,488,113,785”

(iii) Line 7, the figure “5.12” is corrected to read “5.13”.

(b) First full paragraph, last line, the mathematical expression “$38,859 (($39,389 + $38,328)/2)).” is corrected to read “$38,788 (($39,317 + $38,259)/2)).”

(3) Third column, first partial paragraph, lines 33 and 34, the figure “5.52 percent” is corrected to read “5.51 percent”.

b. Lower fourth of the page, in the untitled table, the figure “0.944837” is corrected to read “0.944910”.

4. On page 49433, second column, first full paragraph, line 6, the figure “2.36 percent” is corrected to read “2.37 percent”.

5. On page 49435, first column,

a. First partial paragraph, line 22, the figure “5.53 percent” is corrected to read “5.54 percent”.

b. First full paragraph,

(1) Line 6, the figure “0.01 percent” is corrected to read “0.03 percent”.

(2) Lines 8 through 12, the phrase “estimated outlier payments for capital-related PPS payments would equal 5.52 percent (5.53 percent −0.01 percent) of inpatient capital-related payments” is corrected to read “estimated outlier payments for capital-related PPS payments would equal 5.51 percent (5.54 percent−0.03 percent) of inpatient capital-related payments”.

(3) Line 14, the figure “0.9448” is corrected to read “0.9449”.

c. Second full paragraph,

(1) Lines 4 through 7, the sentence “The FY 2023 outlier adjustment of 0.9448 is a −0.24 percent change from the FY 2022 outlier adjustment of 0.9471” is corrected to read “The FY 2023 outlier adjustment of 0.9449 is a −0.23 percent change from the FY 2022 outlier adjustment of 0.9471”.

(2) Lines 9 and 10, the mathematical phrase “0.9976 (0.9448/0.9471)” is corrected to read “0.9977 (0.9449/0.9471)”.

(3) Line 12, the figure “−0.24” is corrected to read “−0.23”.

6. On page 49436, third column,

a. First full paragraph,

(1) Line 9, the figure $483.76” is corrected to read “$483.79”.

(2) Last line, the figure “0.9448” is corrected to read “0.9449”.

b. Last paragraph,

(1) Line 18, the figure “0.24” is corrected to read “0.23”.

(2) Line 22, the figure “2.36” is corrected to read “2.37”.

7. On page 49437,

a. Top of the page, the table “Comparison of Factors and Adjustments: FY 2022 Capital Federal Rate and the FY 2023 Capital Federal Rate” is corrected to read as follows:

b. Lower two-thirds of the page, first column, second full paragraph, last line, the figure “38,859” is corrected to read “$38,788”.

8. On page 49438, second column, first full paragraph, lines 45 and 46, the reference “section 1866(m)(5)” is corrected to read “section 1886(m)(5)”.

9. On page 49450, first full paragraph,

a. Line 11, the figure “$38,859” is corrected to read “$38,788”.

b. Last line, the figure “$38,859” is corrected to read “$38,788”.

10. On page 49453, bottom of the page, the table titled “TABLE 1D—CAPITAL STANDARD FEDERAL PAYMENT RATE—FY 2023” is corrected to read as follows:

1. On page 49457, third column, last paragraph,

a. Line 8, the figure “$1.4 billion” is corrected to read “$1.5 billion”.

b. Line 14, the figure “$1.0 billion” is corrected to read “$0.9 billion”.

2. On pages 49461 through 49463, the column titled “All FY 2023 Changes” in the table titled, “Table I—Impact Analysis of Changes to the IPPS for Operating Costs for FY 2023” is corrected to read as follows:

3. On pages 49467 through 49468, the table titled “Table II—Impact Analysis of Changes for FY 2023 Acute Care Hospital Operating Prospective Payment System (Payments per discharge)” is corrected to read as follows:

The purpose of this rule is to extend the maximum validity period of merchant mariner medical certificates issued to first-class pilots (FCPs), and masters or mates serving as pilot, from 2 years to 5 years, which will reduce the frequency that they must submit a medical certificate application to the Coast Guard. Reducing the frequency of medical certificate applications will reduce the administrative burden on the mariner submitting the application and on the Coast Guard when processing the application and issuing the medical certificate. First-class pilots, and masters and mates serving as pilot on vessels of 1,600 gross registered tons or more, will be required to submit the results of their annual physical examinations to the Coast Guard between medical certificate applications if the mariner (1) does not meet the physical ability requirements; (2) has a condition that does not meet the medical, vision, or hearing requirements; (3) is deemed “not recommended” by a medical practitioner for a medical certificate; or (4) if the results are requested by the Coast Guard. We are delaying the effective date of this final rule several months after publication in the Federal Register because the Coast Guard needs additional time to fully implement the necessary changes to the Merchant Mariner Licensing and Documentation database used by the National Maritime Center to issue Merchant Mariner Credentials and maintain records of U.S. merchant mariners.

The legal basis of this rule is Title 46 of the United States Code (U.S.C.), Section 7101(c), which authorizes the Coast Guard to issue licenses to pilots who are found qualified as to physical fitness and other qualifications in Section 7101(c). Title 46 U.S.C. Section 7101(e)(2) further specifies that an individual may only be issued a license as pilot if they are found to be of sound health and have no physical limitations that would hinder or prevent them in the performance of a pilot's duties. Section 7101(e)(3) also requires each pilot serving on vessels 1,600 gross registered tons (GRT) or greater to have a thorough physical examination each year while holding the license. The Secretary of the Department of Homeland Security (DHS) has delegated these statutory authorities to the Coast Guard through DHS Delegation No. 00170.1(92)(e), Revision No. 01.2, which generally authorizes the Coast Guard to determine and establish the experience and professional qualifications required for the issuance of credentials. Additionally, 14 U.S.C. 102(3) grants the Coast Guard broad authority to issue and enforce regulations for the promotion of safety of life and property on waters subject to the jurisdiction of the United States.

On August 27, 2021, the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Pilots' Medical Certificate Validity Period” (volume 86 of the Federal Register (FR) at page 48090), requesting comments on extending the pilot medical certificate validity period to 5 years and adding specific reporting requirements for the interim years. The Coast Guard received six comment submissions to the docket. A detailed description of the background and discussion of the proposed changes can be found in that NPRM.

The Coast Guard issues Merchant Mariner Credentials (MMCs) and medical certificates to qualified mariners who meet the requirements in Title 46 of the Code of Federal Regulations (CFR), subchapter B, parts 10 through 13. The requirements for medical certification are described in 46 CFR part 10, subpart C. According to § 10.301, a medical certificate will be issued for various periods of time based upon the endorsements the mariner holds. Under this final rule, the maximum validity period of the medical certificate for mariners serving as an FCP, or masters or mates serving as pilot under 46 CFR 15.812, for which the maximum validity period of the medical certificate had been 2 years, will now have a maximum validity period of 5 years. The validity period of the medical certificate will remain 5 years for mariners serving on national MMC endorsements, and will remain 2 years for mariners engaged on vessels to which the International Convention on Standards of Training, Certification and Watchkeeping for Seafarers (STCW Convention) applies. Mariners may not be employed in a position requiring an MMC unless they hold a valid medical certificate, as described in § 15.401(c).

In accordance with § 11.709, FCPs, and masters or mates serving as pilot on vessels of 1,600 GRT or more, are required to have an annual physical examination that meets the medical and physical requirements described in part 10 subpart C. This annual physical examination requirement for pilots serving on vessels of 1,600 GRT or more has been in place since the enactment of the Port and Tanker Safety Act of 1978 (Pub. L. 95-474) and is codified in 46 U.S.C. 7101(e)(3). This annual physical examination is a statutory requirement and will still be required after this rulemaking.

In July 2017, the Coast Guard tasked the Merchant Marine Personnel Advisory Committee, the Merchant Mariner Medical Advisory Committee, and the Great Lakes Pilotage Advisory Committee with identifying regulations, guidance, or information collections that that were outdated, ineffective, or exceeded benefits and imposed administrative burdens or costs on the maritime industry (see 82 FR 32511, 82 FR 32513, and 82 FR 34909).

The advisory committees concluded that the 2-year maximum validity period of the medical certificate for FCPs poses a burden on mariners and suggested the Coast Guard extend the period of validity to 5 years. Additionally, in July 2018, the Coast Guard received a petition for rulemaking from the American Pilots Association requesting that we change the maximum period of validity of the medical certificate from 2 years to 5 years for FCPs and masters or mates serving as pilot. You can view the American Pilots' Association's petition for rulemaking and our response by searching the docket number “USCG-2018-0709” on https://www.regulations.gov.

In response to the August 27, 2021 NPRM (86 FR 48090), the Coast Guard received six comment submissions to the docket. Three comments expressed support for the proposed rule, two comments disagreed with the proposed rule, and the final comment neither expressed support nor disagreement with the proposed rule. We summarize the comments below. In situations where multiple commenters raised similar issues, we attempt to provide one response.

At the end of this section, we also discuss three clarifying changes to the regulatory text from what was proposed in the NPRM.

A comment from a towing company supported the Coast Guard's proposed rule, stating that it would consolidate all phases of the process to renew an MMC and make the process, as a whole, less burdensome. The commenter also expressed belief that the overall risk of a marine incident occurring on navigable waters due to a pilot's or master's medical condition to be relatively low.

A comment from the American Pilots Association supported the changes in the proposed rule, including the reporting requirements. The American Pilots Association concurred with our statement in the NPRM that this change would not compromise or decrease navigational safety. The American Pilots Association asserted that these changes would actually increase safety because of the new requirement that pilots must submit the results of their annual physical examination to the Coast Guard for review if the medical practitioner determines that they no longer meet the medical and physical standards of 46 CFR, part 10, subpart C.

Another comment simply stated that they agreed with the NPRM.

Two comments from mariners disagreed with the proposed rule. Both raised concerns that the proposed rule would decrease safety because pilots would receive less medical scrutiny at a time when aging pilots are more likely to develop physical ailments and limitations. One of these comments suggested that the proposed rule would mean that the Coast Guard would have less opportunity to remove an endorsement or review further medical proof of ability to act in the capacity of shipboard pilot. This same comment also pointed out that the actual physical examination is only a few hours long and should be considered part of the requirements of the job. The other comment disagreeing with the NPRM suggested that it would be better to require a stress test from a board-certified cardiologist for those mariners seeking to hold a first class pilot endorsement.

The Coast Guard disagrees that the rule would decrease safety and that we should add a stress test for FCPs. We expect the final rule will not decrease safety because it maintains the current medical and physical requirements for FCPs and for masters and mates serving as pilot. Specifically, the final rule maintains the provisions of 46 CFR 11.709 requiring an annual physical examination for FCPs and those serving as pilot. Each annual physical examination must meet the requirements of 46 CFR part 10 subpart C by ensuring that the mariner has no conditions that pose a significant risk of sudden incapacitation or debilitating complication, and by documenting any condition requiring medication that impairs cognitive ability, judgment, or reaction time. The examination must also document the individual's ability to meet the physical ability requirements of 46 CFR 10.304(c), the vision requirements of 46 CFR 10.305, and the hearing requirements of 46 CFR 10.306. Therefore, this final rule will continue to provide an opportunity to identify individuals who no longer meet the medical standards of 46 CFR part 10 subpart C.

The Coast Guard also expects the final rule to maintain the same level of safety on navigable waters because the rule will require FCPs and those serving as pilot to submit the results of their annual physical examinations to the Coast Guard no later than 30 calendar days after completion of the physical examination if the mariner does not meet the physical ability requirements or the medical, vision, or hearing requirements; if the mariner is deemed “not recommended” by a medical practitioner for a medical certificate; or within 30 days upon request by the Coast Guard. If the results of an examination are requested by the Coast Guard, the mariner must submit the results no later than 30 days after the date of the request. This will allow the Coast Guard the opportunity to review the examination to determine whether the individual is physically and medically fit to pilot a vessel.

Furthermore, the Coast Guard expects the final rule to maintain the same level of safety on navigable waters because it retains the provisions of revised 46 CFR 11.709(c), which declares, in part, that an individual's FCP endorsement becomes invalid if the person does not meet the physical examination and reporting requirements in this section. Individuals may not operate under the authority of an invalid endorsement, and those who do may be subject to enforcement action, up to and including suspension and revocation under § 10.235. Additionally, the revised provision in § 11.709(d) states that masters and mates may not serve as pilot on vessels 1600 GRT or more if they do not comply with the physical examination and reporting requirements.

Lastly, Coast Guard expects that the final rule will maintain the same level of safety on navigable waters because it does not extend the medical certificate validity period for individuals who have medical conditions that warrant time-limited medical certificates; nor does it remove reporting requirements for individuals with medical waivers.

With regard to the comment that all FCPs should be required to undergo stress testing by a cardiologist, changing the components of the physical examination requirements for FCPs and masters and mates is outside the scope of this rulemaking. It is important to note that the Coast Guard did not propose any changes to the components of the physical examination requirements for FCPs and masters and mates. The Coast Guard believes that the current physical examination requirements are sufficient for pilots at this time and would not propose changes to the physical examination requirements without information to support such a proposal. No changes to the physical examination requirements would be made without first issuing a proposed rulemaking and following notice-and-comment procedures.

The sixth comment submission we received was from an instructor who stated that their students reviewed the NPRM while studying regulatory policy and took a vote, with the majority supporting the proposed changes.

There are three clarifying changes to the regulatory text of this final rule from the NPRM.

The first change is separating the two general physical examination reporting requirements that, in the NPRM, were combined in § 11.709(b). In the final rule, we are placing the 5-year physical exam submission requirement into new paragraph (b)(1), and the four supplemental reporting requirements into paragraph (b)(2). The four reporting requirements, for when the mariner does not meet the medical requirements or when requested by the Coast Guard, will be in (b)(2)(i) through (b)(2)(iv). Separating the reporting requirements into subparagraphs will make it clearer to the reader that there are multiple reporting requirements.

The second clarifying edit is in § 11.709(b)(2)(iii), regarding when the examining medical practitioner documents that the individual is not recommended for a medical certificate or needs further review by the Coast Guard. This edit clarifies that the recommendation should be recorded on form CG-719K, the “Application for Medical Certificate.”

The third clarifying change is in § 11.709(b)(2)(iv). This edit clarifies that the physical examination results must be submitted to the Coast Guard no later than 30 days from the date of the request, and not within 30 days of completion of the physical examination, as stated in the proposed rule. Because submission within 30 days of completion of the physical examination would not have been applicable in all cases where the Coast Guard requests the results, we clarified that the mariner must submit the results of an examination no later than 30 days after the request.

A detailed description of the regulatory changes implemented by this final rule follows.

This rule increases the 2-year maximum period of validity of the medical certificate for FCPs and masters or mates serving as pilot to a 5-year maximum period of validity. FCPs and masters or mates serving as pilot will be required to submit the results of a physical examination, recorded on form CG-719K, the “Application for Medical Certificate,” every 5 years to the Coast Guard. The following provides a section-by-section discussion of the changes.

The Coast Guard is amending 46 CFR 10.301, which contains the general requirements for meeting the medical and physical standards for the issuance of medical certificates to mariners. We are extending the 2-year maximum period of validity of the medical certificate for FCPs, and those serving as pilot, by deleting § 10.301(b)(2), which contains the 2-year maximum provision. This section will state that pilots will be issued a medical certificate with a maximum validity period of 5 years.

The standard maximum periods of validity for medical certificates in § 10.301(b)(1) for all persons employed or engaged onboard vessels to which the STCW Convention applies remains 2 years. With this final rule, the standard maximum period of validity for medical certificates in § 10.301(b) for national endorsements (including FCPs and mariners serving as pilot) will be 5 years. FCPs and masters or mates serving as pilot will generally only have to submit a medical certificate application to the Coast Guard every 5 years. Pilots holding a medical certificate with a 2-year validity period will be issued a medical certificate with 5-year maximum period of validity at their next medical certificate issuance, unless the certificate is time-limited due to a medical condition. This change reduces the administrative burden on FCPs, masters and mates serving as pilot, and the Coast Guard.

This rule does not change the regulations in § 10.303 regarding medical waivers, limitations, and restrictions for not meeting the medical and physical requirements of § 10.302. If the medical or physical standards are not met, the Coast Guard may grant waivers with conditions, such as operational limitations or restrictions on the medical certificate. Certain conditions, such as a need for more frequent monitoring of the mariner's medical condition, may result in the issuance of a time-limited medical certificate that would be valid for a shorter period than the maximum period of 5 years.

The medical certificate maximum validity period of 5 years will apply to all pilots (excluding pilots with time limited medical certificates due to medical condition), regardless of the tonnage of the vessel they are serving on. The Coast Guard believes that this increase in the validity period will not compromise maritime safety, as the rule does not relax the annual physical examination requirement for FCPs or masters and mates serving as pilot. Instead, we expect that the rule will support greater transparency regarding a pilot's medical fitness because it includes a new requirement that pilots must submit the results of their annual examination to the Coast Guard for review if the medical practitioner determines that they no longer meet the medical and physical standards of 46 CFR, part 10, subpart C.

Prior to this final rule taking effect, FCPs and masters or mates serving as pilot exclusively on vessels of less than 1,600 GRT were issued medical certificates with a maximum validity period of 2 years, and were required to submit the physical examination results with their application for a new medical certificate every 2 years. These mariners are not subject to the annual physical examination requirement in § 11.709 and are not subject to the new submission requirements in § 11.709 of this rule. Pilots, masters, and mates who serve as pilot only on vessels less than 1,600 GRT will be issued medical certificates with a maximum validity period of 5 years and will submit the results of a physical examination to the Coast Guard every 5 years when applying for a new medical certificate.

In the rule titled “Implementation of the Amendments to the International Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978, and Changes to National Endorsements,” (78 FR 77796, Dec. 24, 2013)(STCW final rule), which took effect on March 24, 2014, an error was made in Table 15.812(e)(1) indicating that mariners serving as pilot on vessels less than 1,600 GRT were required to complete an annual physical examination. The supporting text in § 15.812 remained accurate and did not require these mariners to complete the annual physical examination. This rule corrects the table by removing the requirement for an annual physical examination. Masters and mates serving as pilots on vessels less than 1,600 GRT were not required to take an annual physical examination either before or after the STCW final rule.

Lastly, paragraph § 10.301(b) is dedicated to establishing periods of validity, and § 10.301(b)(4) is not related to periods of validity. Therefore, in this rule, § 10.301(b)(4) is redesignated into its own paragraph in § 10.301(c). As a result, current § 10.301(c) is redesignated as § 10.301(d).

Section 11.709 contains the requirement for pilots of vessels 1,600 GRT or more to undergo an annual physical examination. This section specifies when the annual physical examinations must be conducted, how the examination results are recorded, and how often the examination results are reported to the Coast Guard.

To ensure consistency with 46 U.S.C. 7101(e)(3), we clarify the applicability of this section by including masters or mates serving as pilot on vessels of 1,600 GRT or more, under § 15.812, in the introductory text of § 11.709(b). Adding these mariners to § 11.709(b) clarifies the applicability of the annual physical examination requirements.

Paragraph (b) of this section currently states that the examination results are to be reported to the Coast Guard every other year to coincide with the current 2-year maximum period of validity of medical certificates. Because this rule extends the pilot's medical certificate to a 5-year maximum period of validity, we are also removing the every-other-year submission requirement of form CG-719K for pilots. This rule revises the section to state that the physical examination results must be submitted on form CG-719K to the Coast Guard every 5 years, in accordance with the medical certificate application requirements in §§ 10.301 and 10.304. In practice, pilots who meet the medical and physical standards in 46 CFR part 10 will generally be required to report the results of the annual examination to the Coast Guard only when applying for a medical certificate, every 5 years.

The Coast Guard recognizes that when medical certificates remain valid for 5 years, as opposed to 2 years, there is a higher risk that someone could have a valid medical certificate for a significant period after developing a disqualifying medical condition. In order to reduce the risk created by extending the validity period of the medical certificate, this rule requires FCPs and masters or mates who serve as pilot on vessels of 1,600 GRT or more to submit their annual physical examination results to the Coast Guard no later than 30 days after completion of the physical examination if any of the following circumstances occur: (1) the examining medical practitioner documents that the individual does not meet the physical ability requirements described in § 10.304(c); (2) the examining medical practitioner documents that the individual has a condition that does not meet the general medical examination requirements described in § 10.304(a), the vision requirements described in § 10.305, or the hearing requirements described in § 10.306; (3) the examining medical practitioner documents that the individual is not recommended for a medical certificate or needs further review by the Coast Guard; or (4) if the Coast Guard requests the results. If the Coast Guard requests the results, they should be submitted no later than 30 calendar days after the request.

We are requiring self-submission of medical examinations to the Coast Guard when the examined pilot does not meet the requirements for physical abilities, general medical examination, vision, or hearing, or is not recommended for a medical certificate, so that the Coast Guard can further review the results of the medical examination. As part of the review, the Coast Guard may request additional information in the interest of mariner safety and full performance of the pilot's duties.

Service on vessels may be arduous, and imposes unique physical and medical demands on pilots. The submission requirements support our statutory responsibility under 46 U.S.C. 7101 to ensure that pilots are physically and medically fit to pilot a vessel. The public safety risks associated with the medical and physical condition of pilots on vessels are important considerations for the safe operation of vessels and the safety and well-being of the crew. As stated in § 11.709(b), the pilot's annual physical examination will continue to be recorded on form CG-719K, which documents physical ability, medical conditions, and hearing and vision requirements. Form CG-719K also documents whether a mariner is “not recommended,” which could prompt a submission under the requirements in § 11.709(b)(2)(i)-(iii). If a pilot or a master or mate serving as pilot on a vessel 1,600 GRT or more is “not recommended” on their Form CG-719K and fails to report their physical examination results as required under § 11.709(b), they may not serve as pilot on a vessel 1,600 GRT or more until they come into compliance and the Coast Guard makes a determination on whether they are fit to serve under the provisions in 46 CFR subchapter B. The annual physical examination documentation and scope are unchanged and remain the same under this rule.

Moreover, the Coast Guard can request the results of the physical examination as part of marine casualty investigations, where more frequent monitoring of a medical condition is specified in a waiver, and in other cases that prompt further review.

As stated in § 11.701(d), the Coast Guard only issues FCP endorsements for tonnages of 1,600 GRT or more. Therefore, all FCPs serving under the authority of their FCP endorsement will continue to be required to undergo the statutorily required annual physical examinations and will be subject to the submission requirements in § 11.709.

In § 11.709, we also move the text specifying that each annual physical examination must meet the requirements in 46 CFR, part 10, subpart C, and be recorded on form CG-719K, from existing paragraph (c) into paragraph (b). We move this requirement into paragraph (b) so that all information regarding annual physical examination requirements is in the same paragraph.

In conjunction with moving paragraph (c) into paragraph (b), this rule redesignates current § 11.709(d) as § 11.709(c), without change.

Finally, this rule adds a new paragraph 11.709(d) to clarify that masters or mates serving as pilot on vessels of 1,600 GRT or more under § 15.812 may not serve on these vessels if they do not meet the annual physical examination and submission requirements specified in § 11.709(b). New paragraph (d) does not change any of the current requirements or consequences for masters or mates serving as pilot on vessels of 1,600 GRT or more, but reiterates the annual physical examination requirements for masters or mates serving as pilot already required in § 15.812. Masters or mates serving as pilot on vessels of 1,600 GRT or more who do not comply with the physical examination or reporting requirements in § 11.709(b) may still operate under the authority of their master or mate endorsement, but cannot pilot a vessel of 1,600 GRT or more until they come into compliance and the Coast Guard makes a determination on whether they are fit to serve under the provisions of 46 CFR 15.812 and 46 CFR subchapter B.

This rule also aligns the employment requirements in § 15.401 with the 5-year maximum period of validity of medical certificates for FCPs or masters or mates serving as pilot so that it reflects the change made in § 10.301(b). Section 15.401(c) states that a person may not employ or engage an individual in a position required to hold an MMC unless that individual maintains a current medical certificate. This section currently lists the maximum validity period of the medical certificate as 2 years for FCPs and masters or mates serving as a pilot. This rule amends this section to say that the maximum validity period of the medical certificate for FCPs and masters or mates serving as pilot is 5 years.

Additionally, throughout § 15.401, this rule removes obsolete terminology referring to licenses, certificates of registry, and Merchant Mariner's Documents (MMDs). The Coast Guard ceased issuing licenses, certificates of registry, and MMDs in 2009 when we transitioned to the streamlined MMC with the “Consolidation of Merchant Mariner Qualification Credentials” final rule (see 74 FR 11195, March 16, 2009). All credentialed mariners now hold an MMC.

We also revise § 15.401(c)(1) by removing the outdated grandfathering clause, “[a]fter January 1, 2017,” because the referenced date has passed and the section is now applicable to all medical certificates issued to individuals serving on vessels where the STCW Convention applies.

This rule includes a correction to Table 1 to § 15.812(e)(1). Section 15.812(b)(2) contains the requirements for masters or mates to serve as pilot on vessels of not more than 1,600 GRT. There is no requirement in paragraph (b)(2) of this section for these masters and mates serving on vessels less than 1,600 GRT to undergo an annual physical examination. This is consistent with § 11.709(a), which stipulates that the annual physical examination requirement only applies to individuals who pilot a vessel of 1,600 GRT or more. However, in Table 1 to § 15.812(e)(1), “Quick Reference Table for Federal Pilotage Requirements for U.S.-Inspected, Self-Propelled Vessels, Not Sailing on Register,” the requirement for a master or mate serving as pilot on vessels not more than 1,600 GRT to have an annual physical examination was added in error. This error was incorporated into the table with the implementation of the STCW final rule, which took effect on March 24, 2014. We are removing the erroneous annual physical examination requirement in Table 1, under the third column, “Non-designated areas of pilotage waters (between the 3-mile limit and start of traditional pilotage routes).” This correction aligns the table with the corresponding regulatory text in section § 15.812(b)(2), as well as the applicability of the annual physical examination requirements in § 11.709(a). This correction does not change the requirements for these mariners, because the Coast Guard has not required masters or mates serving as a pilot on vessels of less than 1,600 GRT to complete an annual physical examination.

The Coast Guard received six comment submissions during the 60-day comment period that ended on October 26, 2021. We received no public comments on the estimated benefits and costs; therefore, the methodology employed in the regulatory analyses in the NPRM remains unchanged.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on these statutes or Executive orders.

Executive Orders 12866 (Regulatory Planning and Review) and 13563 (Improving Regulation and Regulatory Review) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

The Office of Management and Budget (OMB) has not designated this rule a significant regulatory action under section 3(f) of Executive Order 12866. A regulatory analysis follows.

This rule extends the maximum validity period of merchant mariner medical certificates issued to FCPs and masters or mates serving as pilot from 2 years to 5 years. This rule reduces the frequency of medical certification application submissions to the Coast Guard. FCPs and masters and mates who serve as pilot on vessels of 1,600 GRT or more will be required to submit the results of their annual physical examinations to the Coast Guard between medical certificate applications if the mariner: (1) does not meet the physical ability requirements; (2) has a condition that does not meet the medical, vision, or hearing requirements; (3) is deemed “not recommended” by a medical practitioner for a medical certificate; or (4) is so requested by the Coast Guard.

The Merchant Mariner Licensing and Documentation database (MMLD) is used by the NMC to issue MMCs and maintain records of U.S. merchant mariners. Based on data obtained from the MMLD, we determined that a total of 3,897 mariners hold MMC endorsements as FCPs. This rule will not impact FCPs holding medical certificates issued with waivers requiring more frequent reporting of medical examination results to the Coast Guard. Based on data from the MMLD, this group currently consists of 195 mariners, which is 5 percent of the total affected population of 3,897 mariners. We reduced the total population (3,897 mariners) by this number (195) to obtain a net affected population of 3,702 mariners who will be impacted by this rule.

Additionally, we determined that there are 89,713 mariners who hold an MMC endorsement as master or mate, without holding an FCP endorsement, who could serve as pilot. Because there is no requirement to report when a master or mate serves as pilot, we are unable to determine how many masters or mates are serving as pilot; therefore, we limited the affected population in this analysis to mariners holding FCP endorsements and medical certificates without time-limited medical waivers. Table 2 presents this population.

This final rule reduces the frequency of mariner medical certificate applications to the Coast Guard, resulting in a cost savings to both mariners and the government. Industry cost savings are the costs avoided by reducing the frequency with which FCPs and masters or mates serving as pilot apply for a medical certificate. Consequently, fewer applications will reduce the NMC's workload, generating cost savings for the government. The total 10-year discounted cost savings of this rule will be $257,511, and the annualized total cost savings will be approximately $36,664, both discounted at 7 percent. This includes the 10-year industry and government savings of $146,847 and $110,664 respectively, discounted at 7 percent.

We did not factor mariner turnover into this analysis. “Mariner turnover” means the number or percentage of mariners leaving employment within a certain period of time, combined with the number or percentage of mariners obtaining employment within the same period of time. There are two reasons for not factoring in mariner turnover. First, the MMC serves as a certificate of mariner identity, service, and qualification. In order to serve under the authority of an endorsement on an MMC, a mariner must be physically and medically qualified for that endorsement, as evidenced by holding a valid medical certificate. Medical certification is not an endorsement of qualification on an MMC, but, instead, is a separate document certifying medical and physical fitness to serve in the capacity of an endorsement listed on the MMC.

The second reason mariner turnover is not factored into this analysis is because the FCP endorsement represents a maritime qualification that can lead to permanent employment with a pilot association. This career path is highly competitive, due to the rigorous, time-consuming, and highly specialized training required. As presented in table 3, data from the MMLD indicates that the number of mariners holding an FCP endorsement has declined at an annual average rate of 0.48 percent in the last 11 years. We did not include mariner turnover because the Coast Guard believes it will have a negligible effect in assessing the costs or cost savings for this regulatory analysis. We did not receive any comments related to the impact of mariner turnover in response to the NPRM.

This final rule amends requirements so that the results of the annual physical examinations for pilots, and masters or mates serving as pilot, on vessels of 1,600 GRT or more will be submitted to the Coast Guard on form CG-719K every 5 years instead of every 2 years, unless one of the four conditions noted previously, and listed in § 11.709(b), is applicable. 1 Although mariners will still be required to complete an annual physical examination, the cost savings to industry will include the time savings of the affected population not having to submit an application for a merchant mariner medical certificate every 2 years, after the second year of the implementation of this rule.

Mariners may submit medical certificate applications either directly to the NMC via email or to a Regional Examination Center (REC) via email, fax, or mail. Additionally, applications may be submitted at a REC in person. Cost savings to industry will include the time saved by mariners by faxing, emailing, mailing, or delivering in-person the form CG-719K to the Coast Guard on a less frequent basis. According to data obtained from the MMLD, 95 percent of medical certificates issued to FCPs, or 3,702 (0.95 × 3,897), are renewed every 2 years. The remaining 5 percent are renewed annually, for those pilots with time-limited certificates due to medical waivers. Since the merchant mariner medical certificate for FCPs and masters or mates serving as pilot is only valid for 2 years under current regulations, half the total number of FCPs and masters or mates serving as pilot are currently applying for a new medical certificate each year.

Current data from the MMLD indicates that 195 mariners from the affected population will not benefit directly under this rule. This is the number of FCPs and masters or mates serving as pilot who have been issued medical certificates with a waiver, which require more frequent reporting of the results of their annual physical examinations to the Coast Guard. These mariners will still be required to submit the form CG-719K to the Coast Guard on an annual basis.

We analyzed the number of endorsed FCPs who will experience a reduction in burden from only needing to submit their medical certificate applications once every 5 years, after the second year of the implementation of this rule, as opposed to once every 2 years under the regulations that existed prior to this final rule. We then analyzed the number of endorsed FCPs to estimate a population growth rate for mariners with MMCs who will become newly endorsed as FCPs. Using 11 years of data from the MMLD, from 2010 to 2020, 2 which is presented in table 3, we found that the number of endorsed FCPs is declining at an average rate of 0.48 percent per year. The highest number of endorsed FCPs was observed in 2017, while the lowest number of endorsed FCPs was observed in 2020.

We used this estimated annual average decline of 0.48 percent as a constant when forecasting the endorsed FCP population for the next 10 years. This constant rate represents the average decline experienced by FCPs throughout a 10-year period of analysis. We applied this 0.48 percent rate of decline to both the affected population in former regulations (the baseline) and the affected population in this final rule to determine the number of medical certificate application submissions in a given year. Table 3 presents the data from the MMLD used to determine the estimated annual rate of decline for the endorsed FCP population where t denotes the period of time, and t is discrete and positive.

Table 4 illustrates the following discussion of our baseline analysis. In order to calculate the cost savings of this rule, and to determine our baseline industry costs, we first estimated the number of endorsed FCPs who will be applying for a merchant mariner medical certificate in any given year for the next 10 years, excluding those with medical waivers. To obtain this number, we took the total number of endorsed FCPs holding a medical certificate with or without time-limited medical waivers, 3,897, as shown in table 2. We then subtracted the number of endorsed FCPs who submit medical certificate applications on an annual basis due to time-limited restrictions, 195. We obtained a population of 3,702 endorsed FCPs who will submit their medical certificate applications every 5 years under the rule. We then divided this number (3,702) by 2, which is the application rate of FCPs who are currently issued medical certificates (1 application every 2 years) to obtain an annual estimate of 1,851 medical certificates issued (3,702 ÷ 2). However, the number of endorsed FCPs has decreased over time, at an average annual rate of 0.48 percent from 2011-2020. We incorporated this average annual rate of decline in order to obtain the expected number of endorsed FCPs in a 10-year period of analysis. Column (d) in table 4, “Pre-NPRM Regulation Medical Certificate Applications With Decline,” captures the affected population after applying the annual average rate of decline in column (b) and the application rate in column (c). The equation for column (d) is represented as (d) t = (c) t + ([1 + (b)] t ) for all t. Table 4 presents the number of medical certificate applications under the baseline analysis.

Table 5 illustrates the following discussion of our methodology for estimating the number of medical certificate applications for the affected population under this rule. This is similar to the previously discussed “Baseline” section. The population and the estimated rate of decline are assumed to be identical under both the baseline scenario and the final rule. The difference in the methodology for the final rule is reflected in the application frequency for FCPs. We calculated this by taking the number of FCPs expected to submit a medical certificate application in a given year, incorporating the rate of decline, and assuming that each eligible remaining FCP will only submit a medical certificate application at intervals of 5 years, starting in year 1. Column (e) reflects this periodicity; FCPs who submit a medical certificate application in year 1 will not have to submit a new medical certificate application until year 6. FCPs who submit their medical certificate application in year 2 will not have to submit their medical certificate application until year 7. After accounting for the yearly attrition projected for this analysis, values for column (e) will be equivalent to values of column (d) t for t = 1,2,6,7, and 0 for any other period. This periodicity holds true for any given 10-year interval into the future.

In contrast, column (f) reflects the reduction in medical certificate applications under this rule. For any given period t, the reduction in medical certificate applications is calculated as the difference between FCPs who otherwise submit a medical certificate application every other year under the regulations that existed prior to this final rule, column (d), and the number of FCPs who no longer have to submit a medical certificate application during years 3,4,5,8,9,10. Hence, column (f) t = 0 for t = 1,2,6,7, and column (f) t = (d) t − (e) t for any other year. Finally, column (g) reflects the number of FCPs lost to the industry on a given year due to the projected attrition.

As reflected in sum of column (f) of table 5, we project an aggregate reduction in medical certificate applications of 10,766 over a 10-year period following the implementation of this rule. Under this final rule, on average, FCPs will not have to submit 1,794 medical certificate applications in 3 years out of a given 5-year period horizon.

Table 6 illustrates the analysis of cost savings to industry as discussed in the following paragraphs. We first determine the number of FCPs who will submit a medical certificate application via mail, previously estimated by the NMC at 15 percent of the affected population. The number of FCPs who no longer have to submit a medical application on a given year is reflected on column (f) of table 5. Therefore, column (a) of table 6 is the product of reduced FCPs × 15%. We then estimate the reduction in hours under the final rule.

We calculate the reduction in time burden in a given year from FCPs who no longer have to submit a medical certificate application. The reduction in time burden is calculated as the product of the average time per medical certificate application submitted by mail for evaluation, and the number of FCPs who no longer have to submit a medical certificate application in a given year. The current collection of information approval for MMC application forms estimates the total time required to fill out and submit the medical certificate application by mail to be 18 minutes. Subject matter experts holding MMCs, with experience submitting a medical certificate application, estimate that, on average, 13 minutes are required to fill out the application and the remaining 5 minutes, or 0.083 hours (5 ÷ 60), are required to mail the application. Column (f) in table 6 is the product of (a) and (b). In order to calculate the government cost savings from time saved by NMC employees having fewer medical certificate applications to evaluate, we use an estimated loaded hourly wage rate of $94.03. 3 We derive the estimated wage by using the Office of Personnel Management's 2020 Salary Table for the locality adjusted general service (GS) pay scale for the Washington, DC metropolitan area.

We estimate that the average hourly wage rate for a GS-13 medical evaluator at the NMC is $56.57. 4 To account for employee benefits, we use a load factor of 1.66, which we calculate from the Congressional Budget Office report, “Comparing the Compensation of Federal and Private-Sector Employees, 2011 to 2015.”  5 We obtain this figure (the loaded factor) by dividing the total hourly compensation of a typical GS-13 employee, $74.80, 6 by the hourly wage of a typical GS-13 employee, $45.00;  7 hence, $74.80 ÷ $45.00 = 1.66. 8 Therefore, we estimate the loaded wage rate of a typical GS-13 employee as the product of the wage rate and the load factor, or $56.57 × 1.66 = $94.03.

We recognize that many mariners holding FCP endorsements are compensated at higher wage rates than what is published by the Bureau of Labor Statistics (BLS); however, we used the BLS Occupational Series due to the lack of official records for FCP wages and salaries.

In order to calculate the cost of time saved by FCPs submitting fewer applications under this rule, we use the loaded hourly wage rate per FCP, estimated at $64.90. We obtain an estimated hourly wage rate for a mariner of $43.14, using BLS' Occupational Series 53-5021, Captains, Mates, and Pilots of Water Vessels (May 2020). 9 To determine the load factor per FCP, we divide the BLS total compensation for the transportation and material moving series, 10 $32.27, by the wages and salaries for the same series, which is $21.45. We estimate the load factor as 1.50, as $32.27 ÷ $21.45 = 1.50. Therefore, we calculate the loaded hourly wage rate by multiplying the hourly wage rate by the loaded factor, or $43.14 × 1.50 = $64.90. 11

After determining the total reduction in time for FCPs not submitting medical certificates in a given year, we estimate the aggregate cost of the time for all FCPs to submit their medical certificates applications to the Coast Guard by multiplying the loaded hourly wage-rate per each endorsed FCP, $64.90, by the total annual reduction in time burden. Therefore, the cost-time burden, column (g) of table 6, is the product of column (d) and column (f).

Mariners may submit medical certificate applications either directly to the NMC or to a REC. Whether submitting to the NMC or a REC, applications can be submitted by email, fax, or mail. An application may also be submitted to a REC in person.

Using data from the NMC on the submission of medical certificate applications, we estimate that approximately 39 percent of medical certificate applications are submitted directly to the NMC. Of these applications, 89 percent are submitted by email, 6 percent are submitted by fax, and 5 percent are submitted by mail. The remaining 61 percent of medical certificate applications are submitted to RECs, where 52 percent of the applications are submitted by email, 1 percent are submitted by fax, 22 percent are submitted by mail, and 25 percent are submitted in person. 12 Therefore, of the total medical certificate applications submitted to the Coast Guard (to both the NMC and RECs), approximately 66 percent are submitted via email, 3 percent are submitted via fax, 15 percent are submitted via mail, and 15 percent are submitted in person. 13

We estimate the expected cost of mailing applications through the U.S. Postal Service (USPS) in any given year as the product of the total number of medical certificate applications that will be submitted under this rule, the 55-cent cost of mailing an application to the Coast Guard through the USPS using a first-class letter postage stamp, and the percentage of endorsed FCPs expected to submit their medical certificate applications through the mail, approximately 15.4 percent. Thus, column (h) of table 6 = (a) × (c). Finally, the undiscounted industry cost savings, column (i), is the sum of the cost-time burden, column (g), and the USPS cost, column (h).

Table 7 illustrates the analysis of cost savings to industry, as discussed in the following sections. We first determine the number of FCPs who will submit a medical certificate application in person, previously estimated by the NMC at 15 percent of the affected population. Therefore, column (a), the expected number of medical certificate applications submitted in person in a given year = reduced FCPs × 15%. We assume that each eligible FCP will commute an average of 27.6 minutes in each direction  14 to submit their medical certificate application to a REC, for an average total commuting time of 55.2 minutes, shown in column (c). We assume that FCPs who have a longer commute to the REC will submit the applications by mail or email. We also assume that FCPs will drive at an average speed of approximately 57 miles per hour (MPH) based on calculations from data in the Department of Transportation's National Traffic Speeds Survey II, Overall Speed Estimates (in MPH) by Road Class (Free-Flow) by Year. That survey provided mean speed figures for three road classes: limited access (70.5 MPH), major arterial (53.28 MPH), and minor arterial (47.01 MPH). We took the mean of those values to obtain an average speed of 56.93 MPH [(70.5 + 53.28 + 47.01) ÷ 3]. 15 Considering the estimated average speed, we assume that 55.2 minutes of commuting time will be traveled in approximately 1 hour (55.2 minutes ÷ 57 miles per hour ≉ 0.97 hrs.), reflected in column (b).

In order to calculate the opportunity cost of having to commute to submit a medical certificate application to a REC on a less frequent basis, we use the General Services Administration's (GSA's) “Privately Owned Vehicle (POV) Mileage Reimbursement Rates,”  16 which is used as a proxy for the wear and tear incurred while commuting to a REC. As of January 2021, the reimbursement rate is $0.56 per mile, column (d). We then estimate the net reduction in time burden hours in column (e).

The net reduction in time burden is calculated as the product of the average time it will take FCPs to commute to and from a REC, column (b), and the number of FCPs who no longer have to submit a medical certificate on a given year, column (a). Hence, column (e) = (a) × (b). Next we estimate the net reduction in distance (miles avoided) by FCPs who no longer have to drive to submit a medical certificate application in a given year. The net reduction in distance (miles), column (f), is the product of the average miles avoided by FCPs who would otherwise commute to and from a REC, column (c), and the aggregate time of commuting avoided by FCPs in hours. Finally, we estimate the undiscounted cost savings of FCPs who no longer have to submit a medical certificate application in person, column (g). This column is calculated as the product of GSA's reimbursement rate, column (d), and the aggregate distance (miles) avoided by FCPs on a given year, column (e). Hence, column (g) = (d) × (f).

Table 8 illustrates an analysis similar to table 7, but in terms of the compensation that FCPs will otherwise forgo in order to commute to a REC to submit a medical certificate application. Based on data provided from each REC, we determined that, considering security protocols, a mariner requires an average of 25 minutes to arrive at, enter, and then exit a REC, column (c). It requires, on average, an additional 5 minutes of wait time to be seen by the legal instruments examiner at the customer service counter, column (d), and an additional 1 minute for the examiner to verify that the medical certificate application is complete and filled out properly, column (e). The time burden for FCPs is no different than for any other mariner.

To quantify the savings associated to mariners not using a full hour of their time to commute to a REC, column (b), we use the FCP's loaded hourly wage rate, estimated at $64.90, column (f). The undiscounted cost savings associated to FCPs who no longer have to commute to submit a medical certificate application, column (g), is calculated as the product of the number of reduced FCPs, column (a), the average commuting time to and from a REC, column (b), the average time to it takes an FCP to enter and exit a REC, column (c), the average time to it takes for an FCP to be seen by a legal instruments examiner at the customer service counter, column (d), and the average time it takes for the examiner to verify that the medical certificate application is complete and filled out properly, column (e). Hence, (g) t = (a) t × [(b) + (c) + (d) + (e)] × (f).

Using a 7-percent discount rate, we estimate the annualized cost savings for this rule at $20,908 and the 10-year total at $146,847. We obtain this value by adding the yearly cost savings associated with the number of medical certificate applications not submitted in a given period, which is column (i) of table 6, and the number of medical certificate applications not delivered to the Coast Guard in a given period, which is the sum of column (g) of table 7 and column (g) of table 8. We present these industry cost-savings amounts, discounted at 7 percent and 3 percent, in table 9.

Table 10 illustrates the following methodology to calculate the cost savings to the government. We first estimate the reduction in hours associated with the reduction in medical certificate application submissions previously discussed as the product of the reduction in medical certificate applications and the estimated time it will take a GS-13 employee at the NMC to process an application for a medical certificate. Using medical certificate application information records obtained from NMC medical evaluation staff, we estimate that the time needed to evaluate a medical certificate application is approximately 10 minutes, or 0.166 hours (10 ÷ 60 = 0.166 hours).

Using the loaded hourly wage rate of $94.03 for a GS-13 employee, we estimate that the government will save $15.67 ($94.03 × 0.17 hour) on each application it no longer has to evaluate. The annual reduction in the number of medical certificate applications for the rule is the product of the number of applications the government will no longer have to review and the hours saved by not having to review an additional medical application. Therefore, (d) = (a) × 0.166 hrs. On average, the government will save 299 hours annually under this final rule.

Next, we estimate the total undiscounted government cost savings in a given year. We calculated this by multiplying the estimated loaded hourly wage rate for a GS-13 employee, $94.03, by the yearly reduction in hours. This captures the difference in the medical certificate applications under the former regulations and the final rule. On average, the government will save $18,444 annually under this rule, discounted at 7 percent, as presented in table 10.

Over a 10-year period of analysis, the total estimated cost savings of this rule to mariners and the government is $257,511, discounted at 7 percent. The annualized cost savings are $36,664, also discounted at 7 percent. Table 11 presents the total cost savings of this rule, which is the sum of the undiscounted industry savings, column (c) of table 9, and the undiscounted government savings, which is column (e) of table 10. Therefore, the undiscounted total cost savings is the sum of the undiscounted industry savings and the undiscounted government savings.

The cost savings accounted for above, including savings to mariners from less frequent submissions of medical certificate applications, are quantifiable benefits from this rule. This rule will reduce the NMC's workload and generate government cost savings.

When analyzing alternatives, we considered two factors: the period of validity of the medical certificate for FCPs; and the requirement to submit physical examination results to the Coast Guard. Prior to this final rule, the period of validity of the medical certificate was 2 years for FCPs, and the submission of physical examination results was correspondingly every other year, unless the medical certificate contained a waiver requiring more frequent submission of the physical examination results.

Alternative 1. The first alternative we considered in this analysis was no change, where FCPs would continue to apply for their medical certificates every other year. This alternative would also continue to require FCPs to report their physical examination results every other year, unless their medical certificate contains a waiver requiring more frequent submission. As shown in table 11, we estimate the opportunity cost of maintaining a 2-year pilot medical certificate validity period at $36,664, annualized at 7 percent; or a total of $257,511 over a 10-year period of analysis, also discounted at 7 percent. We rejected this alternative. Although there would be no additional costs to mariners or the government, there would also be no cost savings, and this alternative would not lead to an increase in safety in the maritime industry.

Alternative 2. The second alternative we considered was extending the maximum period of validity of medical certifications to 5 years without interim self-reporting requirements, which require mariners to submit the results of their medical examination to the Coast Guard if they no longer meet the medical standards. FCPs would only submit the results of the physical examination every 5 years with a medical certificate application, unless their medical certificate contains a waiver and requires more frequent submission. We rejected this alternative. The Coast Guard finds the potential for increased risk from mariners with underlying health issues operating as FCPs, and not self-reporting medical or health conditions that may impact their piloting performance and maritime safety, unacceptable. We made this determination after considering the unique physical and cognitive demands placed on pilots in performing their duties, and maritime casualties that were directly related to a FCP's physical ability to perform their duties. We considered casualties such as the 2003 Staten Island Ferry allision, which resulted in more than $8 million in damages and losses, and the 2007 Cosco Busan incident, which resulted in more than $70 million in environmental damages and other losses. Both casualties were directly attributed to the pilot's inability to properly manage the vessel due to underlying medical conditions that were not reported to the Coast Guard within the 5-year medical certificate validity period. The risk that mariners can develop new medical conditions within the 5-year medical certificate validity period is mitigated by the self-reporting requirements. Taking into account these maritime casualties, and the potential for extraordinary damages to the public, the environment, and the maritime industry, the Coast Guard does not deem any potential benefit derived from excluding the interim self-reporting requirement on behalf of FCPs to be worth the risk involved.

Alternative 3. The third alternative we considered was extending the maximum period of validity of the medical certificate to 5 years, and requiring FCPs to submit the results of their annual physical examinations to the Coast Guard between medical certificate applications if the mariner: (1) does not meet the physical ability requirements; (2) has a condition that does not meet the medical, vision, or hearing requirements; (3) is deemed “not recommended” by a medical practitioner for a medical certificate; or (4) is so requested by the Coast Guard. With this third alternative, FCPs would apply for the medical certificates every 5 years and would have to report the results of their medical examination between applications only if any of the four conditions apply. This alternative mitigates the potential for increased safety risks identified under the second alternative, resulting from having mariners with underlying medical issues operating as FCPs. The potential for risk is increased when the Coast Guard does not have the opportunity to review the physical examinations of mariners whose medical practitioners have diagnosed them with medical conditions that may impact their piloting performance. Therefore, the third alternative was chosen in this rule.

Under the Regulatory Flexibility Act, 5 U.S.C. 601-612, we have considered whether this rule will have a significant economic impact on a substantial number of small entities. 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.

This rule will reduce the burden on industry by extending the maximum period of validity of merchant mariner medical certificates for FCPs and masters and mates serving as pilot from 2 years to 5 years. Because the medical certificate application is submitted by the mariner and not an employer, the affected mariners will receive the cost savings from this rule. Hence, the changes in this rule will affect individuals, not businesses or other small entities as defined by the Small Business Administration in 13 CFR 121.201.

Therefore, 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.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121, we offer to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking. 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.

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).

This rule calls for a change to an existing collection of information under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 3520. As defined in 5 CFR 1320.3(c), “collection of information” comprises reporting, recordkeeping, monitoring, posting, labeling, and other similar actions. The title and description of the information collection, a description of those who must collect the information, and an estimate of the total annual burden follow. The estimate covers the time for reviewing instructions, searching existing sources of data, gathering and maintaining the data needed, and completing and reviewing the collection.

The information collection associated with this rule is the currently approved collection, OMB Control No. 1625-0040, Application for Merchant Mariner Credentials and Medical Certificates, which covers all information collected for merchant mariner credentialing. The revisions to 46 CFR 10.301 and 15.401 will extend the maximum validity period of the mariner medical certificate for FCPs and masters or mates serving as pilot from 2 years to 5 years. The change to the maximum validity period of the medical certificate for pilots will reduce the frequency and burden of response estimates of the current information collection request.

Title: Application for Merchant Mariner Credentials and Medical Certificates.

OMB Control Number: 1625-0040.

Summary of the Collection of Information: The Coast Guard currently collects information from merchant mariners with their applications for MMCs and merchant mariner medical certificates. This collection includes the following information requests: signature of the applicant and supplementary material required to show that the mariner meets the mandatory requirements for the credential or medical certificate sought; proof of the applicant passing all applicable vision, hearing, medical, and physical examinations; negative chemical test for dangerous drugs; discharges or other documentary evidence of sea service indicating the name, tonnage, propulsion mode and power of the vessels, dates of service, capacity in which the applicant served, and on what waters; and disclosure documentation for narcotics, driving while intoxicated or under the influence, or other convictions.

Need for Information: Title 46 U.S.C. Subtitle II, Part E, 46 CFR part 10 subpart B, the STCW Convention and STCW Code, including the STCW final rule (78 FR 77796), require MMC and medical certificate applicants to apply at one of the Coast Guard's 17 RECs located nationwide, or any other location designated by the Coast Guard. MMCs are established for individuals who are required to hold a credential under Subtitle II. The Coast Guard has the responsibility of issuing MMCs and medical certificates to applicants found qualified as to age, character, and habits of life, experience, professional qualifications, and physical fitness. The instruments contained within OMB Control No. 1625-0040 serve as a means for the applicant to apply for an MMC and a medical certificate.

Proposed Use of Information: The Coast Guard conducts this collection of information solely for the purpose of determining eligibility for the issuance of an MMC or medical certificate, in accordance with applicable statutes and regulations. This evaluation is performed on occasion, meaning as submitted by the respondent when they apply for an MMC or medical certificate. In general, applicants for an MMC must submit the “Application for Merchant Mariner Credential,” form CG-719B, every 5 years for renewal, or when seeking a new endorsement or raise of grade, and applicants for a medical certificate must submit the form CG-719K every 2 years or every 5 years, depending upon the type of credential endorsements held and the applicant's medical status. The Coast Guard evaluates the collected information to determine whether applicants are qualified to serve under the authority of the requested credential with respect to their medical fitness, their professional qualifications, and their safety and suitability.

Description of the Respondents: All applicants for an MMC, whether original, renewal, duplicate, raise of grade, or a new endorsement on a previously issued MMC, are included in this collection. Medical certificates are issued with three expiration dates based on the endorsement type. The effective expiration date depends upon the authority upon which the mariner is currently sailing, which may be on a National MMC endorsement, an international STCW endorsement, or a pilot endorsement. This rule only changes the maximum validity period of the pilot endorsement merchant mariner medical certificate from 2 years to 5 years, which applies only to FCPs and masters or mates serving as pilot.

Number of Respondents: This rule will reduce the annual number of respondents by 7,324 over a 10-year period of analysis. As a result, the total annual respondents for this collection will change from 18,316 to 10,992.

Frequency of Response: For FCP endorsements, the annual average reduction will be 1,794. The responses are annual and will result in a reduction in the number of medical certificate submissions of the form CG-719K from 54,800 to 44,034 (54,800−10,766 = 44,034).

Burden of Response: The total hourly burden per response is estimated at 18 minutes, or 0.30 hours. This rule will reduce the aggregate burden of hours associated with the submission of the medical certification applications by extending the validity period from every 2 years to every 5 years. Therefore, the total annual response time for submitting a new medical certificate will decrease by approximately 3,587 hours (138 hrs. via mail submissions + 1,654 hrs. in person submissions + 1,794 government hrs. review). However, the hourly burden per response will remain unchanged.

Estimate of Total Annual Burden: The Coast Guard estimates that the total annual burden with the change to the medical certificate validity period for FCPs will be 16,286 hours a year, which is a 154-hour reduction in burden from the current corresponding collection total of 16,440 hours.

As required by 44 U.S.C. 3507(d), we will submit a copy of this rule to OMB for its review of the collection of information. You are not required to respond to a collection of information unless it displays a currently valid OMB control number.

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

It is well settled that States may not regulate in categories reserved for regulation by the Coast Guard. It is also well settled that all of the categories covered in 46 U.S.C. 3306, 3703, 7101, and 8101 (design, construction, alteration, repair, maintenance, operation, equipping, personnel qualification, and manning of vessels), as well as the reporting of casualties and any other category in which Congress intended the Coast Guard to be the sole source of a vessel's obligations, are within the field foreclosed from regulation by the States. See the Supreme Court's decision in United States v. Locke and Intertanko v. Locke, 529 U.S. 89, 120 S.Ct. 1135 (2000) (finding that the states are foreclosed from regulating tanker vessels). See also Ray v. Atlantic Richfield Co., 435 U.S. 151, 157 (1978) (state regulation is preempted where “the scheme of federal regulation may be so pervasive as to make reasonable the inference that Congress left no room for the States to supplement it [or where] the Act of Congress may touch a field in which the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject.” (Citations omitted). Because this rule involves the credentialing of mariners under 46 U.S.C. 7101, it relates to personnel qualifications and, as a result, is foreclosed from regulation by the States. Therefore, because the States may not regulate within these categories, this rule is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

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. Although this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630 (Governmental Actions and Interference with Constitutionally Protected Property Rights).

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988 (Civil Justice Reform) to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045 (Protection of Children from Environmental Health Risks and Safety Risks). This rule is not an economically significant rule and will not create an environmental risk to health or risk to safety that might disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments), because it will 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.

We have analyzed this rule under Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use). We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

The National Technology Transfer and Advancement Act, codified as a note to 15 U.S.C. 272, directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management 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. 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.

This rule is categorically excluded under paragraphs L56 and L54 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev 1. Paragraph L56 pertains to regulations concerning the training, qualifying, licensing, and disciplining of maritime personnel. Paragraph L54 pertains to regulations which are editorial or procedural. This rule involves amending the maximum period of validity of merchant mariner medical certificates from 2 years to 5 years for FCPs, and masters or mates serving as pilot on vessels of 1,600 GRT or more. Additionally, the rule includes an extension of the annual physical examination submission requirement from every other year to every 5 years, as long as circumstances do not require more frequent submissions of annual physical examination results to ensure maritime and public safety.

For the reasons discussed in the preamble, the Coast Guard amends 46 CFR parts 10, 11, and 15 as follows:

Why we need to publish a rule. Under the Act, a species warrants reclassification from endangered to threatened if it no longer meets the definition of an endangered species (in danger of extinction throughout all or a significant portion of its range). The palo de rosa was listed as endangered May 10, 1990 (55 FR 13488, April 10, 1990), and we are finalizing our proposed reclassification of the palo de rosa as threatened. We have determined the palo de rosa does not meet the Act's definition of an endangered species but it does meet the definition of a threatened species (likely to become an endangered species throughout all or a significant portion of its range). Reclassifying a species as a threatened 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. This rule revises part 17 of title 50 of the Code of Federal Regulations (50 CFR part 17) to reclassify the palo de rosa from an endangered to a threatened species on the Federal List of Endangered and Threatened Plants and establish provisions under section 4(d) of the Act that are necessary and advisable to provide for the conservation of this species (a “4(d) rule”).

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. Based on the status review, the current threats analysis, and evaluation of conservation measures discussed in this rule, we conclude that the palo de rosa no longer meets the Act's definition of an endangered species and should be reclassified to a threatened species. The species is no longer in danger of extinction throughout all or a significant portion of its range, but is likely to become so within the foreseeable future. The palo de rosa is affected by the following current and ongoing threats: habitat loss, degradation, and fragmentation from urban development; agricultural practices and rights-of-way maintenance coupled with habitat intrusion by exotics; other natural or manmade factors, such as hurricanes; and the species' slow growth, limited dispersal, and low recruitment.

We are promulgating a section 4(d) rule. We are adopting the Act's section 9(a)(2) prohibitions as a means to provide protective mechanisms to the palo de rosa. We include specific tailored exceptions to these prohibitions to allow certain activities covered by a permit or actions with seeds of cultivated specimens accompanied by a statement of “cultivated origin.”

For the convenience of the reader, the following list explains abbreviations and acronyms used in this document:

Please refer to the proposed rule to reclassify the palo de rosa published on July 14, 2021 (86 FR 37091), for a detailed description of previous Federal actions concerning this species.

In the proposed rule published on July 14, 2021 (86 FR 37091), we requested that all interested parties submit written comments on the proposal by September 13, 2021. We also contacted appropriate Federal and State agencies, scientific experts and organizations, and other interested parties and invited them to comment on the proposal. Newspaper notices announcing the proposed rule and inviting general public comment were published in Spanish and English in the El Nuevo Dia newspaper. We did not receive any requests for a public hearing or public comments on the proposed rule.

In accordance with our policy, “Notice of Interagency Cooperative Policy for Peer Review in Endangered Species Act Activities,” which was published on July 1, 1994 (59 FR 34270), and our August 22, 2016, Director's Memorandum “Peer Review Process,” we sought the expert opinion of five appropriate and independent specialists regarding scientific data and interpretations contained in the proposed rule and received no responses. We also requested review from our Federal and Territorial partners and received no comments.

We have made minor typographical or stylistic changes and corrections, but no substantive changes, to the July 14, 2021, proposed rule (86 FR 37091).

A thorough review of the taxonomy, life history, ecology, and overall viability of the palo de rosa was presented in the 5-year review (USFWS 2017, entire) and the proposed rule published July 14, 2021 (86 FR 37091). Below, we present a brief summary of the biological and distributional information for the palo de rosa. Please refer to the 5-year review and proposed rule for more detailed information.

The palo de rosa is a small evergreen tree that may reach up to 15 meters (m) (49 feet (ft)) in height and is a member of the Icacinaceae family (USFWS 1994, p. 1). The branches are smooth and dark gray with ovate, round, or elliptic leaves (Liogier 1994, p. 41). Flowers are solitary or grouped in a three- to five-flower cluster, and the small fruit is smooth with a thin outer layer that turns dark purple when ripe. The seed is about 2 centimeters (cm) (0.8 inches (in)) long (Liogier 1994, p. 41; Santiago Valentín and Viruet-Oquendo 2013, p. 62). Palo de rosa trees may be difficult to identify based on sterile material.

When the palo de rosa recovery plan was written, information about the flowering and fruiting pattern was limited due to the species not being well-studied and the infrequent observation of reproductive events, although flowering was observed in May and July 1993 (USFWS 1994, p. 5). The species bears hermaphrodite flowers, flowers for a short period at the beginning of the rainy season and develops fruits subsequently until November (Breckon and Kolterman 1993, p. 15; Santiago-Valentín and Viruet-Oquendo 2013, p. 62). Few buds and flowers occur from April to May with an explosive flowering in June coinciding with the beginning of the rainy season in May. Herbarium specimens demonstrated flowering and fruiting between May and July (Santiago-Valentin and Viruet-Oquendo 2013, p. 62). Flower and fruit production are documented in individuals with diameters at breast height greater than 5 in (12.7 cm). Despite the high number of adult individuals reported, only a few reach that stem size (Breckon and Kolterman 1993, p. 15; USFWS 2009, unpubl. data).

The cluster distribution of seedlings under the parent trees indicates that seeds are dispersed by gravity. Subpopulations in northern Puerto Rico are located on top of limestone hills indicating that some disperser ( e.g., animal vector) took them there in the past although no species has been observed acting as a seed disperser (Breckon and Kolterman 1993, p. 15); USFWS 2017, p. 12). Dispersal by water has been hypothesized for the subpopulations in the southern coast located at the bottom of small drainages. However, establishment of seedlings in these drainages is low likely because seeds are buried by sediments and small plants are uprooted by high flows (Monsegur-Rivera 2007, pers. obs.).

Due to the infrequency of fruit production, germination experiments have been limited. Attempts to germinate seeds from the Dorado (Mogotes de Higuillar) population (northern Puerto Rico) have proven to be difficult (10 percent success) as the majority of seeds were attacked by insects (Coleoptera) (Ruiz Lebrón 2002, p. 2). The species also has been germinated by PRDNER and the University of Puerto Rico with a 50 percent germination success (Caraballo 2009, pers. comm.). Propagation of the species is feasible and may be used in palo de rosa recovery efforts. Palo de rosa saplings have been planted in the Susúa and Guajataca Commonwealth Forests as well as on lands within Fort Buchanan, which is owned by the U.S. Army. Palo de rosa is not known to reproduce vegetatively although multiple stems may regrow from a tree that has been cut.

The palo de rosa was described by Ignatius Urban (1908) from material collected by Leopold Krug near the municipality of Mayagüez in 1876 (Liogier 1994, p. 42). Based on the description of the type locality, the collection site may correspond to an area known as Cerro Las Mesas. At the time of listing, the palo de rosa was known from nine individuals in three areas and considered endemic to Hispaniola and Puerto Rico (55 FR 13488, April 10, 1990, p. 13489). Subpopulations and populations were not defined or identified at the time of listing. The species was known from the limestone hills near the municipality of Bayamón in northern Puerto Rico, several sites in the Guánica Commonwealth Forest (GCF) in southwest Puerto Rico, and one individual on the southern slopes of the Maricao Commonwealth Forest (55 FR 13488, April 10, 1990, p. 13489).

At the time the recovery plan was written in 1994, there was little information on the species' distribution, ecology, and reproductive biology; therefore, in the recovery plan, species experts considered each subpopulation or cluster of individuals as a population. The recovery plan describes additional individuals observed as a result of increased survey efforts in suitable habitat. In the 1994 recovery plan, we estimated 200 palo de rosa individuals in 16 populations (now defined as subpopulations and noted with “(RP)” in the table in the proposed rule). An additional population (now considered a subpopulation) was reported in 1996, increasing the total number of trees to 207 adult individuals (Breckon and Kolterman 1996, p. 4).

The current understanding of the palo de rosa's biological and ecological requirements has led us to define a population as a geographical area with unique features (substrate or climate) and continuous forested habitat that provides for genetic exchange among subpopulations ( i.e., cross-pollination) where the species occurs. We further considered natural barriers ( e.g., mountain ranges and river valleys) and extensive gaps of forested habitat to discern the boundaries of these broader populations because connectivity between subpopulations is critical to support a functional palo de rosa population due to the cross-pollination requirement of the species. Furthermore, the flowering of the palo de rosa is sporadic and not synchronized, thus prompting us to further define a population as groups of subpopulations that show connectivity to secure cross-pollination. Based on the above information, we have determined the palo de rosa to be distributed across Puerto Rico in 14 populations composed of 66 subpopulations containing 1,144 individuals (not including seedlings). Following this approach, 8 of the 14 current populations (containing 47 subpopulations with approximately 804 individuals) occur in the geographical areas associated with the 16 populations (now defined as subpopulations) included in the Service's 1994 recovery plan. Since 1994, we have identified 6 additional populations (as currently defined) composed of 19 subpopulations (342 individuals) ranging in size from 5 to 124 individuals in areas associated with remnants of forested habitat suitable for the species. Thus, these additional occurrences are key in understanding the current condition of the species.

Currently, the number of palo de rosa individuals has increased from 9 individuals on protected lands at the time of listing to 407 individuals (representing 36 percent of known individuals or 32 percent of subpopulations) occurring in areas managed for conservation ( e.g., Commonwealth Forest and Federal lands). An additional 396 individuals (38 percent of subpopulations) occur in areas subject to little habitat modification due to the steep topography in the northern karst region of Puerto Rico. The remaining 30 percent of the subpopulations (containing approximately 341 individuals) occur within areas severely encroached upon by and vulnerable to urban or infrastructure development. However, the resiliency of all subpopulations depends on interaction (cross-pollination) with nearby subpopulations. Despite the increase in the number of known subpopulations and individuals, there are no records of recruited individuals reaching reproductive size in the past three decades. We also do not have any records of recent dispersal and range expansion of the species. The following discussion provides the most updated information on these populations, and their respective geographical areas. Please refer to our July 14, 2021, proposed rule (86 FR 37097-37100) for a table of the currently known natural populations, subpopulations, and numbers of adult individuals of palo de rosa in Puerto Rico.

The distribution of the palo de rosa extends along the southern coast of Puerto Rico from the municipality of Cabo Rojo east to the municipality of Guayanilla in five geographical areas or populations: (1) Guánica Commonwealth Forest (GCF), (2) Montes de Barinas, (3) Guayanilla-Peñuelas, (4) Susúa Commonwealth Forest (SCF), and (5) Cerro Las Mesas-Sierra Bermeja. In addition, the palo de rosa extends along the northern coast of Puerto Rico from the municipality of Aguadilla east to the municipality of Fajardo in the following nine areas or populations: (1) Aguadilla-Quebradillas, (2) Camuy-Hatillo, (3) Arecibo, (4) Utuado-Ciales, (5) Arecibo-Vega Baja, (6) Dorado, (7) La Virgencita, (8) Mogotes de Nevares, and (9) San Juan-Fajardo (USFWS 2017, p. 11).

The range of the species extends to Hispaniola (Dominican Republic and Haiti) (Acevedo-Rodríguez and Strong, 2012, p. 369; Axelrod 2011, p. 184); however, there is little information on the population structure and status of the palo de rosa in these countries, and information is limited to scattered herbarium collections. In the Dominican Republic, the species occurs in Provincia (Province) de La Altagracia, Provincia de Samaná, Provincia de Puerto Plata, Provincia de Pedernales, and Provincia de San Cristobal (Jardín Botánico Santo Domingo (JBSD), unpubl. data). On the northern coast of Haiti, the palo de rosa has been recorded at “Massif du Nord” along a dry river (JBSD, unpubl. data). However, these herbarium specimens provide no data on the subpopulation or population abundance or number of associated individuals. The palo de rosa is categorized as critically endangered according to the Red List of Vascular Flora in the Dominican Republic ( Lista Roja de la Flora Vascular en República Dominicana ), an assessment of the conservation status of all vascular plants in the Dominican Republic as determined by the Ministry of Higher Education Science and Technology Ministry (Garcia et al. 2016, p. 4).

The palo de rosa occurs in variable habitats but is dependent on the specific microhabitat conditions. On dry limestone forest like the GCF, the species occurs at the bottom of drainages that provide moisture, whereas at the SCF, the palo de rosa occurs along the borders of rivers. The subpopulations along the northern karst of Puerto Rico are found on the top of limestone hills, possibly because those areas have no agricultural value, and so were not impacted by conversion to agricultural lands. Such variability in habitats indicates the species' current fragmented distribution and lack of connectivity between populations are the result of earlier land-clearing and habitat modification. Information from specimens deposited at multiple herbaria ( i.e., New York Botanical Garden, Smithsonian Institution, UPR, UPRRP, and MAPR) suggests the palo de rosa was originally more common and widespread throughout Puerto Rico, even extending to the coastal lowlands of Puerto Rico, including dune ecosystems. Our July 14, 2021, proposed rule (86 FR 37097-37100) includes additional details and information on the current abundance, distribution, and habitat of palo de rosa populations in Puerto Rico.

At least 25 of the 66 subpopulations show evidence of fruit production and seedling or sapling recruitment (USFWS 2017, pp. 8, 11-12). Fruit production and seed germination have been documented in several subpopulations (Monsegur-Rivera 2016, pers. obs.). However, individual palo de rosa saplings and trees grow extremely slowly, with an estimated height of less than 1 m (3.3 ft) after 20 years growth. Under natural conditions, palo de rosa individuals may require at least 40 years to reach a reproductive size, and the currently known subpopulations are experiencing slow recruitment (Monsegur-Rivera 2018, pers. obs.). Palo de rosa seeds are dispersed by gravity, limiting recruitment to the proximity of the parental tree. Thus, the species' potential to colonize further suitable habitat is limited and survival of clustered seedlings may be reduced due to closed canopy conditions and competition with the parental tree.

Population dynamics and survey assessments support the hypothesis that the palo de rosa is a late-successional species whose saplings may remain dormant under closed canopy conditions until there is some natural disturbance that provides favorable conditions for the development of the saplings. Thus, the species may require an open canopy to promote seedling growth and is adapted to natural disturbances such as hurricanes (Breckon and Kolterman 1996). Under this scenario, the natural populations show a slow natural recruitment that requires stable habitat conditions with a regime of natural disturbance ( i.e., tropical storms or hurricanes). Although natural disturbances (e.g ., tropical storms or hurricanes) can promote the recruitment of saplings into adulthood, the palo de rosa population should be composed of different size classes in order to be able to withstand such stochastic events.

Reproductive events ( i.e., flowering and fruiting) have been associated with bigger trees as observed in four subpopulations, where tree diameters reach 13-20.5 cm (5.1-8.1 in) and canopies are higher (at least 10 m) (32.8 ft) (Breckon et al.1992, p. 8; USFWS 2009, p. 4). For example, one large tree in the El Costillar-Río Guajataca subpopulation had an estimated 1,000 seedlings under 1 tree with an almost 90 percent survivorship of 156 monitored seedlings after 18 months (Breckon et al. 1992, p. 8). Further visits to this subpopulation indicate the survival of seedlings and saplings remains high with evidence of additional recruitment (Monsegur-Rivera 2007, 2012, and 2014, pers. obs.).

Recruitment may be intermittent in some subpopulations. For example, a subpopulation with no seedling survival following a fruiting event in 2004 was noted to contain about 30 small saplings in the post-Hurricane María assessment in 2018, suggesting the subpopulation is slowly recruiting (USFWS 2018, p. 25). Since 2009, hundreds of seedlings have been recorded in the Fort Buchanan subpopulation (Monsegur-Rivera 2009-2020, pers. obs.). In 2018, at least 12 saplings ranging from 0.3-1.0 m (0.9-3.3 ft) were observed. Saplings this size can withstand seasonal drought stress, and individuals are likely to persist in the long term if the habitat remains unaltered. Cross-pollination between subpopulation maximizes the likelihood of fruit production and contributes to recruitment, which underscores the importance of conserving the species through a landscape approach.

Of the 26 subpopulations currently showing evidence of natural recruitment, 9 of the 26 occur in areas that are managed for conservation. The 9 subpopulations constitute 36 percent of subpopulations showing natural recruitment and contain nearly 300 individuals in total. There is no evidence of natural recruitment at this time for the remaining 40 subpopulations although the species' life history implies that recruitment may still occur in these subpopulations when a canopy opening is created and suitable conditions for recruitment are present. Forest cover in Puerto Rico has increased since the widespread deforestation in the 1930s-1950s (Marcano-Vega et al. 2015, p. 67), but the availability of suitable habitat prior to deforestation and habitat fragmentation implies the palo de rosa may have had greater abundance and wider distribution. Although current information on population structure indicates the species requires some open canopy areas to promote recruitment, widespread deforestation fragments habitat and creates edges (habitat transition zones). The possible long-term negative effects of habitat fragmentation and edge effect on subpopulations with recruitment adjacent to habitat disturbance are still unknown. Current observations from the 2018 post-hurricane assessment suggest subpopulations encroached by development or agriculture were negatively affected by weedy vegetation invading the habitat following Hurricane María ( e.g., Cayaponia americana (bejuco de torero), Dioscorea alata (ñame), and Thunbergia grandiflora (pompeya). However, the extent of such impact remains uncertain, and further monitoring is needed. Such information highlights the effect of habitat fragmentation on the natural recruitment of the palo de rosa.

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. 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 list.

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, recovery plans 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 criteria 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 or threatened species. In other cases, we may discover new recovery opportunities after having finalized the recovery. 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 fully follow all of the guidance provided in a recovery plan.

The following discussion provides an analysis of the recovery criteria and goals as they relate to evaluating the status of the taxon. The recovery plan for this species does not provide downlisting criteria (USFWS 1994, entire) but indicates the species could be considered for delisting when the following criteria are met: (1) Populations known to occur on privately owned land are placed under protective status; (2) an agreement between the Service and the U.S. Army concerning the protection of the species on their land (Fort Buchanan) has been prepared and implemented; and (3) mechanisms for the protection of the palo de rosa have been incorporated into management plans for Maricao, Guánica, Susúa, and Cambalache Commonwealth Forests. The plan also notes that, given the discovery of additional populations, priority should be given to enhancement and protection of existing populations in protected areas and on privately owned land (USFWS 1994, p. 13). At the time the recovery plan was written, only 200 individuals in 16 populations (currently defined as subpopulations) were known. In addition, the lack of recruitment in palo de rosa populations was not known to be a concern; therefore, recovery criteria primarily address protection of palo de rosa habitat. We apply our current understanding of the species' range, biology, and threats to these delisting criteria to support our rationale for why downlisting is appropriate. Details regarding the delisting criteria and the degree to which they have been met are described in the proposed reclassification rule and have not changed.

Delisting criterion 1 has been partially met. At the time the recovery plan was written, 4 of 16 populations (now defined as subpopulations) occurred on private lands. Currently, of the 66 known palo de rosa subpopulations, 45 are located on private lands with 3 of these managed for conservation.

Federal and Territorial conservation efforts have resulted in habitat protections that benefit the Yauco Landfill palo de rosa subpopulation and maintain connectivity between subpopulations (PRDNER 2015b, p. 1). In addition, the PRDNER has increased the protected area in the GCF from the approximately 4,016 ha (9,923 ac) in 1996 to at least 4,400 ha (10,872 ac) (Monsegur 2009, p. 8). While delisting criterion 1 has been only partially met, with the identification of additional individuals, populations, and subpopulations, only 341 (29 percent) of the known 1,144 palo de rosa individuals occur on private lands with no protection. Currently, 407 individuals (representing 36 percent of known individuals or 32 percent of subpopulations) occur in areas managed for conservation.

Together with our partners, we have met delisting criterion 2 through an MOU specifying protection and management of the Fort Buchanan populations (U.S. Army, Fort Buchanan 2015, entire). Lastly, we determine delisting criterion 3 to be obsolete. Although species-specific management plans do not exist for Commonwealth forests, the natural reserves are managed for conservation by PRDNER as recommended by the Master Plan for the Commonwealth Forests of Puerto Rico (DNR 1976, entire). We continue working with PRDNER and other partners to monitor and survey suitable unexplored habitat for the palo de rosa, to develop sound conservation strategies, and to proactively identify priority areas for conservation.

In conclusion, the implementation of recovery actions, in addition to the identification of numerous additional individuals and subpopulations, have reduced the risk of extinction for the palo de rosa. Of the 1,144 adult palo de rosa individuals known, only 341 (29 percent) occur on private lands with no protection. Currently, 407 individuals (representing 36 percent of known individuals or 32 percent of subpopulations) occur in areas managed for conservation. Furthermore, a total of 396 individuals (38 percent of subpopulations) occur in areas subject to little habitat modification due to the steep topography in the norther karst region of Puerto Rico Although many individuals occur on protected lands, we have identified 20 subpopulations throughout Puerto Rico where habitat modification and fragmentation still can occur. Although Puerto Rico's laws and regulations protect the palo de rosa on both public and private lands and other protection mechanisms ( i.e., conservation easements) have been implemented, impacts to palo de rosa subpopulations may occur due to lack of enforcement, misidentification of the species, unsustainable agricultural practices, and unregulated activities (see Summary of Biological Status and Threats, below). Based on the biology of the palo de rosa and its dependence on cross-pollination, impacts that reduce connectivity between subpopulations may affect the breeding capacity of the species and, thus, its long-term recruitment and viability. The recovery of the palo de rosa will include collaboration and partnership efforts with PRDNER and private landowners to develop conservation strategies and recommendations when evaluating urban and infrastructure development projects that could affect these subpopulations. Recovery efforts should be directed toward landscape planning and management strategies that would ensure abundance and distribution of palo de rosa subpopulations to allow cross-pollination and recruitment and contribute to the long-term recovery of the species.

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 is an “endangered species” or a “threatened species,” issuing protective regulations for threatened species, and designating critical habitat for threatened and endangered species. In 2019, jointly with the National Marine Fisheries Service, the Service issued final rules that revised the regulations in 50 CFR parts 17 and 424 regarding how we add, remove, and reclassify threatened and endangered species and the criteria for designating listed species' critical habitat (84 FR 45020 and 84 FR 44752; August 27, 2019). At the same time, the Service also issued final regulations that, for species listed as threatened species after September 26, 2019, eliminated the Service's general protective regulations automatically applying to threatened species the prohibitions that section 9 of the Act applies to endangered species (collectively, the 2019 regulations).

However, on July 5, 2022, the U.S. District Court for the Northern District of California vacated the 2019 regulations ( Center for Biological Diversity v. Haaland, No. 4:19-cv-05206-JST, Doc. 168 (N.D. Cal. July 5, 2022) ( CBD v. Haaland )), reinstating the regulations that were in effect before the effective date of the 2019 regulations as the law governing species classification and critical-habitat decisions. Accordingly, in developing the analysis contained in this final rule, we applied the pre-2019 regulations, which may be reviewed in the 2018 edition of the Code of Federal Regulations at 50 CFR 17.31, 17.71, 424.02, 424.11(d)-(e), and 424.12(a)(1) and (b)(2)). Because of the ongoing litigation regarding the court's vacatur of the 2019 regulations, and the resulting uncertainty surrounding the legal status of the regulations, we also undertook an analysis of whether the final rule would be different if we were to apply the 2019 regulations. That analysis, which we described in a separate memo in the decisional file and posted on https://www.regulations.gov, concluded that we would have reached the same decision if we had applied the 2019 regulations. This is because both before and after the 2019 regulations, the standard for whether a species the meets the definition of an endangered species or a threatened species remains the same under the 2019 regulations as under the pre-2019 regulations. Further, we concluded that our determination of the foreseeable future would be the same under the 2019 regulations as under the pre-2019 regulations.

On September 21, 2022, the U.S. Circuit Court of Appeals for the Ninth Circuit stayed the district court's July 5, 2022, order vacating the 2019 regulations until a pending motion for reconsideration before the district court is resolved ( In re: Cattlemen's Ass'n, No. 22-70194). The effect of the stay is that the 2019 regulations are the governing law. Because of our desire to promptly reclassify a species in a timely manner whenever species meets the definition of a threatened species, rather than revise the proposal in response to the Ninth Circuit's decision for submission of a final rule to the Federal Register , we hereby adopt the analysis in the separate memo that applied the 2019 regulations as our primary justification for the final rule. However, due to the continued uncertainty resulting from the ongoing litigation, we also retain the analysis in this preamble that applies the pre-2019 regulations and we conclude that, for the reasons stated in our separate memo analyzing the 2019 regulations, this final rule would have been the same if we had applied the 2019 regulations.

The Act defines an “endangered species” as a species that is in danger of extinction throughout all or a significant portion of its range. A “threatened species” is defined 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 a species is an “endangered species” or a “threatened species” based on one or any combination 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 have positive effects. We consider these same five factors in downlisting a species from endangered to threatened.

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 expected response by the species 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 now and in the foreseeable future.

The Act does not define the term “foreseeable future,” which appears in the statutory definition of “threatened species.” Because the decision in CBD v. Haaland vacated our 2019 regulations regarding the foreseeable future, we refer to a 2009 Department of the Interior Solicitor's opinion entitled “The Meaning of `Foreseeable Future' in Section 3(20) of the Endangered Species Act” (M-37021). That Solicitor's opinion states that the foreseeable future “must be rooted in the best available data that allow predictions into the future” and extends as far as those predictions are “sufficiently reliable to provide a reasonable degree of confidence in the prediction, in light of the conservation purposes of the Act.” Id. at 13.

It is not always possible or necessary to define foreseeable future as a particular number of years. Analysis of the foreseeable future uses the best scientific and commercial data available and should consider the timeframes applicable to the relevant threats and to the species' likely responses to those threats in view of its life-history characteristics. Data that are typically relevant to assessing the species' biological response include species-specific factors such as lifespan, reproductive rates or productivity, certain behaviors, and other demographic factors.

We consider 50 years to be the foreseeable future within which we can reasonably determine the threats, the magnitude of those threats, and the species' response to those threats. The foreseeable future for the individual factors and threats vary. However, based on the available information from ongoing monitoring of populations known at the time of listing, it is estimated that under natural conditions palo de rosa individuals may require at least 40 years to reach a reproductive size and that the species' reproductive ecology is consistent with late-successional species. Within 50 years, an individual palo de rosa tree would reach a reproductive size and effectively contribute to the next generation. Therefore, this timeframe accounts for maturation, the probability of flowering, effective cross-pollination, setting viable fruits, seed germination, and early seedling survival and establishment while taking into account environmental stochastic events such as drought periods. Some palo de rosa life stages are more sensitive to a particular threat ( e.g., seedling and sapling susceptibility to drought conditions); therefore, the species' response to threats in all life stages and the effects of these responses can be reasonably determined within the foreseeable future (50 years).

We can also reasonably predict development and habitat fragmentation and modification within the next 50 years based on current trends. Furthermore, the established timeframe for the foreseeable future provides for the design and implementation of conservation strategies to protect and enhance currently known populations over the next 50 years.

In terms of climate, we recognize that modelled projections for Puerto Rico are characterized by some divergence and uncertainty later in the century (Khalyani et al. 2016, p. 275). However, we have reasonable confidence in projections within a 50-year timeframe representing the foreseeable future for the palo de rosa because uncertainty is reduced within this timeframe. We assessed the climate changes expected in the year 2070 and determined that downscaled future climate change scenarios indicate that Puerto Rico is predicted to experience changes in climate that will affect the palo de rosa (Khalyani et al. 2016, entire). Thus, using a 50-year timeframe for the foreseeable future allows us to account for the effects of projected changes in temperature, shifting of life zones, and increases in droughts in the habitat.

The 5-year review (USFWS 2017, entire) documents the results of our comprehensive biological status review for the species, including an assessment of the potential threats to the species. The following is a summary of the key results and conclusions from the 5-year review and the best available information gathered since that time. The 5-year review can be found at https://www.regulations.gov under Docket No. FWS-R4-ES-2020-0059.

Below, we review the biological condition of the species and its resources and the threats that influence the species' current and future condition to assess the species' overall viability and the risks to that viability.

Habitat destruction and modification, including forest management practices, were identified as factors affecting the continued existence of the palo de rosa when it was listed in 1990 (55 FR 13488, April 10, 1990). At present, forest management practices within Commonwealth forests are not considered a threat to the palo de rosa because of existing regulatory mechanisms and lack of evidence of direct impacts to the species due to forest management practices. For example, although there is evidence of palo de rosa individuals with multiple stems due to historical deforestation and harvesting for charcoal production in the GCF, selective harvesting and deforestation is no longer a threat to the GCF population. Similar to the GCF, the palo de rosa SCF population (i.e ., Quebrada Peces, Quebrada Grande, and Río Loco subpopulations) is also entirely under conservation, and we have no evidence of adverse impacts to the species due to forest management practices.

However, that is not necessarily the case on private lands; the subpopulations of Montes de Barinas and Guayanilla-CORCO (Commonwealth Oil Refining Company) remain vulnerable to deforestation and habitat modification. In Montes de Barinas, the palo de rosa occurs on private properties subject to urban development resulting in encroachment of native dry forest areas and, thus, in the isolation of the palo de rosa (see 79 FR 53303, September 9, 2014, p. 53307, with reference to threats in the same area). These areas also are threatened by deforestation for cattle grazing and the extraction of timber for fence posts (Román-Guzman 2006, p. 40; see 79 FR 53303, September 9, 2014, p. 53307). In fact, active extraction of timber for fence posts has been reported adjacent to the Montes de Barinas subpopulation and on a neighboring property with other endemic species with palo de rosa individuals in the Montes de Barinas population likely to be cut if harvesting continues (Monsegur-Rivera 2003-2006, pers. obs.; Morales 2011, pers. comm.). In addition, the area of Montes de Barinas showed evidence of bulldozing and subdivision for urban development (Román-Guzman 2006, p. 40).

The habitat at the Guayanilla-CORCO population is impacted on a regular basis by the Puerto Rico Energy and Power Authority (PREPA) for the maintenance of power lines and associated rights-of-way (USFWS 2017, p. 16). Impacts to the species' habitat have been reported in that area as a result of construction of access roads to PREPA towers (Monsegur-Rivera 2014-2020, pers. obs.). Such habitat disturbance and modification affect the integrity of palo de rosa habitat and likely result in direct and indirect impacts to individuals. In fact, some access roads go through drainages that provide good habitat for the palo de rosa and could affect microhabitat conditions necessary for seedling germination and recruitment. In addition, these dirt access roads provide corridors for the establishment of exotic plant species like guinea grass ( Megathyrsus maximus) and zarcilla ( Leucaena leucocephala ), which outcompete the native vegetation (including the palo de rosa) and promote favorable conditions for human-induced fires (USFWS 2017, p. 16). Moreover, these dirt roads are used to access the forested habitat for harvesting of timber for fence posts (Monsegur-Rivera 2014, pers. obs.). Similarly, the habitat in the municipalities of Peñuelas and Ponce ( i.e., Punta Cucharas) near the Guayanilla-Peñuelas population has been severely fragmented by urban development ( e.g., housing development, hotels, a jail, a landfill, rock quarries, and highway PR-2) (see 79 FR 53307, September 9, 2014), and due to maintenance of PREPA power lines (Monsegur-Rivera 2020, pers. obs.).

In Sierra Bermeja and Cerro las Mesas, private forested lands also have been impacted through deforestation mainly for agricultural practices ( i.e., grazing by cattle and goats, and associated conversion of forested habitat to grasslands) and urban development ( i.e., construction of houses and roads) (Cedeño-Maldonado and Breckon 1996, p. 349; USFWS 1998, p. 6; Envirosurvey, Inc. 2016, p. 6). Most of the Sierra Bermeja mountain range was zoned with specific restrictions on development activities to protect the natural resources of the area (Junta de Planificación Puerto Rico (JPPR) 2009, pp. 151-153). This zoning allows for agricultural activities and construction of residential homes with the implementation of best management practices and some limitations (JPPR 2009, p. 151; JPPR 2015, pp. 118-129). Nonetheless, landowners continue impacting the habitat through activities like cutting new access roads on their properties and conversion of forested land to pasture (Pacheco and Monsegur-Rivera 2017, pers. obs.). The palo de rosa population in Sierra Bermeja is limited to two isolated individuals on protected lands (Laguna Cartegena National Wildlife Refuge (LCNWR) and PLN conservation easement) with no evidence of natural recruitment. Similarly, the other two palo de rosa individuals in Guaniquilla-Buye, also in southwest Puerto Rico, are found within private lands subject to urban and tourist development although these plants are not yet impacted.

Core palo de rosa subpopulations occur in the northern karst belt of Puerto Rico (Lugo et al. 2001, p. 1) where approximately 80 percent of the known palo de rosa sites occur on private lands not managed for conservation. These private lands are encroached upon by development and subject to habitat modification activities ( e.g., urban development) detrimental to the palo de rosa. The palo de rosa subpopulation at Guajataca Commonwealth Forest (GuCF) is the westernmost record of the species in northern Puerto Rico that lies within an area managed for conservation. As previously discussed, the GuCF subpopulations extend to private lands along the Guajataca Gorge. Although the steep terrain and low agricultural value of this area has protected the subpopulations from habitat modification, some remain vulnerable to infrastructure development ( e.g., possible expansion of Highway PR-22 between the municipalities of Hatillo and Aguadilla). For example, three previously unknown subpopulations (including one showing recruitment) were located during the biological assessments for the proposed expansion of Highway PR-22 (PRHTA 2007, p. 19).

Another subpopulation vulnerable to habitat modification is the Merendero-Guajataca; this area is managed for recreation, and the habitat remains threatened by vegetation management activities ( e.g., maintenance of green areas and vegetation clearing along trails). Habitat modification can also have implications beyond the direct impacts to a subpopulation. Although the palo de rosa in the Merendero-Guajataca subpopulation have produced flowers, there are no records of fruit production or seedlings (Monsegur-Rivera 2009-2020, pers. obs.); this is likely due to habitat modification at the site. Nonetheless, this subpopulation may interact through cross-pollination with the nearby El Túnel-Guajataca subpopulation and, thus, contribute to observed recruitment in other Guajataca Gorge subpopulations. A palo de rosa subpopulation was located during a biological assessment for the proposed expansion of an existing quarry adjacent to the Río Camuy (Sustache-Sustache 2010, p. 7). We expect that impacts to this subpopulation from the quarry activities will interfere with the natural recruitment of the species along the Río Camuy.

Habitat encroachment is evident on private lands surrounding the Cambalache Commonwealth Forest (CCF), Hacienda La Esperanza Natural Reserve, and Tortuguero Lagoon Natural Preserve where at least six known subpopulations occur within private lands adjacent to areas subject to development or infrastructure projects. The subpopulations at Hacienda Esperanza extend to private lands on their southern boundary where development projects have been proposed ( e.g., Ciudad Médica del Caribe; PRDNER 2013, pp. 24-25). Habitat modification in those areas can result in direct impacts to palo de rosa individuals and interrupt the connectivity between subpopulations ( e.g., cross-pollination). In addition, the analysis of aerial images indicates four additional subpopulations occurring on private lands in the proximity of Hacienda Esperanza are encroached upon by urban development, rock quarries, and agricultural areas (Monsegur-Rivera 2018, pers. obs.).

The palo de rosa subpopulations at Hacienda Sabanera in Dorado have been encroached upon by development. We prepared a biological opinion during the consultation process for the construction of Hacienda Sabanera and its associated impacts on the palo de rosa (USFWS 1999, entire). The biological opinion indicates that approximately 83 of the 200 acres (including forested mogote habitat) would be impacted, and 6 palo de rosa adults, 12 saplings, and 35 seedlings would be directly affected by the proposed project (USFWS 1999, p. 6). Although we concluded that the project would not jeopardize the continued existence of the palo de rosa (USFWS 1999, p. 7), the project resulted in substantial loss of forested habitat promoting edge habitat favorable for intrusion by weedy species. In addition, a series of mogotes along Higuillar Avenue, south of Hacienda Sabanera, are expected to be impacted by proposed road construction (PRDNER 2013, pp. 22-24), and we have no information that plans for the road have been withdrawn.

Encroachment conditions similar to those in Hacienda Sabanera also occur in the areas of La Virgencita (north and south), Mogotes de Nevares, Sabana Seca, Parque de las Ciencias, Parque Monagas, and Fort Buchanan. For example, at La Virgencita, the palo de rosa population is bisected by Highway PR-2 and could be further impacted if the road is widened in the future. Landslides have occurred in this area in the past, and road maintenance in this vulnerable area may trigger slide events (PRDNER 2015a, pp. 13-15). In addition, palo de rosa individuals are found within the PREPA power line rights-of-way (Power Line 41500), and there is evidence the overall decrease or absence of saplings or juveniles in the La Virgencita south population may be the result of habitat modification and resulting edge habitat due to maintenance of the PREPA power line rights-of-way (PRDNER 2015a, pp. 13-15; USFWS 2018, p. 33). In addition, the westernmost palo de rosa subpopulation occurs in the municipality of Aguadilla in an area identified by the Puerto Rico Highway and Transportation Authority (PRHTA) as part of the proposed expansion of highway PR-22 (USFWS 2017, p. 7).

The Mogotes de Nevares, Sabana Seca, Parque de las Ciencias, Parque Monagas, and Fort Buchanan subpopulations are also severely fragmented by urban development and a rock quarry (USFWS 2017, p. 12). Such fragmentation compromises the connectivity between subpopulations. Some of these areas are vulnerable to landslides due to changes in the contour of the terrain associated with a high density of urban development, encroachment, and quarry operations ( e.g., Parque Monagas and Fort Buchanan) (U.S. Army 2014, p. 3). Although Fort Buchanan habitat is set aside for conservation, landslides have occurred within and near the fort, and the subpopulation remains threatened due to potential landslides. Fort Buchanan is evaluating a possible slope stabilization project for the site (U.S. Army 2014, pp. 4, 9-11).

The palo de rosa occurs within several National Parks on Hispaniola (Dominican Republic and Haiti) ( e.g., Parque Nacional del Este, Parque Nacional Los Haitises, and Parque Nacional Sierra de Bahoruco). Despite the occurrence of the species within areas managed for conservation ( e.g., Parque del Este and Sierra de Bahoruco), these areas continue to be affected by illegal deforestation for agriculture and charcoal production, and enforcement of existing regulations is limited (Jiménez 2019, pers. comm.). The dependence of the human population of Haiti on wood-based cooking fuels ( e.g., charcoal and firewood) has resulted in substantial deforestation and forest conversion to marginal habitat in both Haiti and adjacent regions of the Dominican Republic ( e.g., Sierra de Bahoruco). The expected increases in the human population in Haiti will result in an increase in the demand for such fuel resources (USFWS 2018, p. 4).

In fact, deforestation and habitat degradation in the Sierra de Bahoruco and the surrounding region has recently been increasing (Grupo Jaragua 2011, entire; Goetz et al. 2011, p. 5; Simons et al. 2013, p. 31). In 2013, an estimated 80 square kilometers (19,768.4 acres) of forest in the area were lost primarily due to illegal clearing of forested habitat for agricultural activities (Gallagher 2015, entire). Vast areas (including suitable habitat for the palo de rosa) along the border between Haiti and Dominican Republic (including within National Parks) are being cleared and converted to avocado plantations (Monsegur-Rivera 2017, pers. obs.). Such deforestation extends to other National Parks, such as Parque Nacional del Este and Isla Saona, where illegal vegetation clearing for agriculture and tourism development continue to occur (Monsegur-Rivera 2011, pers. obs.). For example, analysis of aerial images from Isla Saona (Parque Nacional del Este) show extensive deforestation and conversion of forested habitat to agricultural lands during the last decade (Monsegur-Rivera 2019, pers. obs.). Impacts to palo de rosa populations due to development and habitat destruction and modification in Hispaniola are not described in the final listing rule for the species (55 FR 13488, April 10, 1990), but current information indicates that the palo de rosa and its habitat are being affected by deforestation for agricultural practices and extraction for fuel resources.

To summarize, forest management practices within Commonwealth Forests are no longer considered a threat to the palo de rosa. The palo de rosa populations at the CCF, GCF, GuCF, Río Abajo Commonwealth Forest (RACF), and SCF are protected as these forest reserves are protected by Commonwealth laws and managed for conservation. Nonetheless, populations extending onto private lands in southern Puerto Rico are vulnerable to impacts from urban development, agricultural practices ( e.g., harvesting fence posts), and maintenance of power lines and rights-of-way (Monsegur-Rivera 2019, pers. obs.). In addition, the majority of the subpopulations along the northern karst of Puerto Rico occur on private lands where habitat encroachment occurs and creates edge habitat conditions (habitat intrusion by exotics that precludes seedling establishment) and affects connectivity and natural recruitment. For example, despite the abundance of individuals at the palo de rosa subpopulation adjacent to the former CORCO in Guayanilla-Peñuelas, recruitment is limited due to the multiple stressors, including maintenance of power line rights-of-way, fence post harvest, and intrusion of exotic plant species, as well as the changes in microhabitat conditions at these sites, which preclude seedling establishment. Furthermore, habitat fragmentation along the northern coast may affect cross-pollination among subpopulations resulting in the lack of fruit production at isolated subpopulations with a smaller number of individuals ( e.g., Merendero-Guajataca).

In the final listing rule (55 FR 13488, April 10, 1990), we identified the inadequacy of existing regulatory mechanisms as one of the factors affecting the continued existence of the palo de rosa. At that time, the species had no legal protection because it had not been included in Puerto Rico's list of protected species. Once the palo de rosa was federally listed, legal protection was extended by virtue of an existing cooperative agreement (under section 6 of the Act) with the Commonwealth of Puerto Rico. Federal listing ensured the addition of the palo de rosa to the Commonwealth's list of protected species, and the Commonwealth designated the palo de rosa as endangered in 2004 (PRDNER 2004, p. 52).

In 1999, the Commonwealth of Puerto Rico approved Law No. 241, also known as the New Wildlife Law of Puerto Rico ( Nueva Ley de Vida Silvestre de Puerto Rico ), which legally protects the palo de rosa. The purpose of this law is to protect, conserve, and enhance both native and migratory wildlife species and declare as property of Puerto Rico all wildlife species within its jurisdiction. The law also regulates permits, hunting activities, and exotic species among other activities. This law also has provisions to protect habitat for all wildlife species, including plants. In 2004, the PRDNER approved Regulation 6766 or Regulation to Govern Vulnerable Species and Species in Danger of Extinction in the Commonwealth of Puerto Rico ( Reglamento para Regir el Manejo de las Especies Vulnerables y en Peligro de Extinción en el Estado Libre Asociado de Puerto Rico ). Article 2.06 of Regulation 6766 prohibits, among other activities, collecting, cutting, and removing of listed plant individuals within the jurisdiction of Puerto Rico (PRDNER 2004, p. 11). The provisions of Law No. 241-1999 and Regulation 6766 extend to private lands. However, the protection of listed species on private lands is challenging as landowners may be unaware that species are protected and may damage those species ( e.g., by cutting, pruning, or mowing) (USFWS 2017, p. 23), which might be the case were a palo de rosa tree cut for fence posts.

Commonwealth of Puerto Rico Law No. 133 (1975, as amended in 2000), also known as Puerto Rico Forests' Law ( Ley de Bosques de Puerto Rico ), protects the areas of the GCF, SCF, GuCF, RACF, and CCF, and, by extension, the palo de rosa individuals on them. Section 8(a) of this law prohibits cutting, killing, destroying, uprooting, extracting, or in any way hurting any tree or vegetation within a Commonwealth forest. The PRDNER also identifies these forests as “critical wildlife areas.” This designation constitutes a special recognition with the purpose of providing information to Commonwealth and Federal agencies about the conservation needs of these areas and to assist permitting agencies in precluding adverse impacts as a result of project endorsements or permit approvals (PRDNER 2005, pp. 211-216). In addition, Commonwealth of Puerto Rico Law No. 292 (1999), also known as Puerto Rico Karst Physiographic Protection and Conservation Law ( Ley para la Protección y Conservación de la Fisiografía Cársica de Puerto Rico ), regulates the extraction of rock and gravel for commercial purposes and prohibits the cutting of native and endemic vegetation in violation of other laws (e.g ., Law No. 241-1999 and Regulation 6766). Law No. 292-1999 applies to karst habitat in both southern and northern Puerto Rico.

On the Laguna Cartegena National Wildlife Refuge (LCNWR), habitat is managed in accordance with the National Wildlife Refuge System Administration Act of 1966 (16 U.S.C. 668dd-668ee, as amended by the National Wildlife Refuge System Improvement Act of 1997 [Improvement Act]), and collection of plants within refuge lands is prohibited by 50 CFR 27.51. The LCNWR has a comprehensive conservation plan that includes measures for the protection and recovery of endangered and threatened plant species (USFWS 2011, p. 35). Furthermore, the Puerto Rico Planning Board (Junta de Planificación de Puerto Rico) classified most of the mountain range of Sierra Bermeja as a District of Conservation of Resources (Distrito de Conservación de Suelos) (JPPR 2009, p. 151). This conservation category identifies lands with particular characteristics that need to be maintained or enhanced ( e.g., provide habitat for species of concern) and establishes specific restrictions for development (JPPR 2009, p. 151). Also, in 2015, the Puerto Rico Planning Board approved the Land Use Plan for Puerto Rico and categorized most of the Sierra Bermeja Mountains, including the LCNWR, as Rustic Soil Specially Protected (Suelo Rustico Especialmente Protegido) where no urban development is considered due to location, topography, aesthetic value, archaeological value, or ecological value of land (Puerto Rico Planning Board Interactive Map 2020).

The palo de rosa individuals found at Hacienda La Esperanza Natural Reserve are protected as this reserve also is managed for conservation by PLN, and the management plan considers the palo de rosa in its activities (PLN 2011a, p. 67). The PLN also manages the Río Encantado Natural Protected Area, a mosaic of at least 1,818 ac (736 ha) of forested habitat (including extensive areas of suitable habitat for the palo de rosa) in the municipalities of Florida, Manatí, and Ciales, and PLN plans to continue acquiring habitat at this geographical area (PLN 2011b, p. 5). Also, the palo de rosa is protected and managed under an MOU among the U.S. Army Garrison, Fort Buchanan, the Service, and PRDNER (U.S. Army, Fort Buchanan 2015, entire). This palo de rosa subpopulation is found in a mogote designated for conservation (USACE 2014, p. 3).

In addition, the private natural reserves of El Tallonal and Mata de Plátano, which contain subpopulations of the palo de rosa in the municipality of Arecibo, are protected from habitat modification and have approved private forest stewardship management plans that include measures for the protection of listed species within the properties (PRDNER 2005, 47 pp.). We have an extended history of collaboration with these two reserves in providing financial and technical assistance for the implementation of recovery actions to benefit listed species.

In addition to protections provided by the Act, the species is protected from collection and provided management considerations by the Improvement Act within one national wildlife refuge (LCNWR). In addition, the Commonwealth of Puerto Rico legally protects the palo de rosa, including protections to its habitat, through Commonwealth Law No. 241-1999 and Regulation 6766, which prohibit, among other actions, collecting, cutting, and removing listed plants. While we are downlisting this species, we do not expect this species to be removed from legal protection by the Commonwealth. Although these protections extend to both public and private lands, as discussed above, protection of this species on private land is challenging. Habitat that occurs on private land is subject to pressures from agricultural practices ( e.g., grazing, harvesting fence posts) and development. Accidental damage or extirpation of individuals has occurred because private landowners or other parties on the property may not be able to identify the species or may not be aware that the palo de rosa is a protected species. Habitat modifications and fragmentation continue to occur on private lands, which can increase the likelihood of habitat intrusion by exotic plants and human-induced fires and reduce connectivity between populations and the availability of suitable habitat for the species' recruitment. In short, this plant is now more abundant and widely distributed, including within conservation land, so the threat due to inadequacy of regulatory mechanisms has been reduced. However, the palo de rosa occurrences on private lands continue to need enforcement of existing prohibitions as well as increased attention and associated outreach to highlight the species' conservation and importance.

Here, we summarize the continuing threat of low recruitment on palo de rosa populations. We describe this influence on palo de rosa viability in greater detail under Recruitment and Population Structure, above. Characteristics of the palo de rosa's life history may contribute to the slow or lack of recruitment observed in current subpopulations (Monsegur-Rivera 2018, pers. obs.). Individual palo de rosa trees grow extremely slowly and may require at least 40 years to reach a reproductive size. Dispersal and colonization of gravity-dispersed palo de rosa seeds are limited, and seedlings face competition from the parental tree. As a late-successional species, palo de rosa requires an open canopy to promote seedling growth and is adapted to stable habitat conditions with a regime of natural disturbances such as hurricanes (Breckon and Kolterman 1996). Cross-pollination between or among subpopulations maximizes the likelihood of fruit production and contributes to recruitment, which underscores the importance of conserving the species through a landscape approach to promote effective crosspollination and natural recruitment. Although current information on population structure indicates the species requires some open canopy areas to promote recruitment, widespread deforestation fragments the remnants of suitable habitat and creates edges (habitat transition zones).

There is no evidence of natural recruitment at this time for 40 of the 66 known subpopulations, although the species' life history implies that recruitment may still occur in these populations when a canopy opening is created and suitable conditions for recruitment are present. Forest cover in Puerto Rico has increased since the widespread deforestation in the 1930s (Marcano-Vega et al. 2015, p. 67), but palo de rosa was likely more widespread prior to deforestation and habitat fragmentation. A life history requirement for a closed canopy forest for adult individuals with canopy openings to promote seedling and sapling recruitment was likely more sustainable in populations with greater abundance and distribution than the species currently exhibits. Smaller and more isolated subpopulations are less able to provide closed canopy conditions with small pockets of openings; thus, inherent palo de rosa life history characteristics have an effect on recruitment, and this effect is expected to continue in the future.

At the time of listing, we considered palo de rosa individuals vulnerable to flash flood events (see 55 FR 13490, April 10, 1990). Flash floods remain a moderate threat and may compromise the natural recruitment of seedlings, particularly on subpopulations along the southern coast of Puerto Rico where the species occurs at the bottom of drainages (USFWS 2017, p. 17). Below, we describe these threats and other natural and human-caused factors affecting the continued existence of the palo de rosa.

As an endemic species to the Caribbean, the palo de rosa is expected to be well adapted to tropical storms and associated disturbances such as flash floods. Under natural conditions, healthy populations with robust numbers of individuals and recruitment should withstand tropical storms, and these weather and climatic events may be beneficial for the population dynamics of the palo de rosa by creating small openings in the closed canopy to allow seedling and sapling growth. The islands of the Caribbean are frequently affected by hurricanes. Puerto Rico has been directly affected by four major hurricanes since 1989. Successional responses to hurricanes can influence the structure and composition of plant communities in the Caribbean islands (Lugo 2000, p. 245; Van Bloem et al. 2003, p. 137; Van Bloem et al. 2005, p. 572; Van Bloem et al. 2006, p. 517). Examples of the visible effects of hurricanes on the ecosystem includes massive defoliation, snapped and wind-thrown trees, large debris accumulations, landslides, debris flows, and altered stream channels, among others (Lugo 2008, p. 368). Hurricanes can produce sudden and massive tree mortality, which varies among species but averages about 41.5 percent (Lugo 2000, p. 245). Hence, small palo de rosa populations may be severely impacted by hurricanes resulting in loss of individuals or extirpation. The impact of catastrophic hurricanes is exacerbated in small populations.

There is evidence of damage to palo de rosa individuals due to previous hurricane events ( e.g., Hurricane Georges in 1998) at the Hacienda Sabanera and Hacienda Esperanza subpopulations (USFWS 2017, p. 17). A post-hurricane assessment of selected palo de rosa populations was conducted to address the impact of Hurricane María (USFWS 2018, entire). Even though Hurricane María did not directly hit the GCF, evidence of damage to palo de rosa trees was recorded at Cañon Las Trichilias ( e.g., uprooted trees and main trunk broken) (USFWS 2018, p. 3). Additional evidence of direct impacts (including mortality) due to Hurricane María were recorded in the Hacienda Esperanza, Hacienda Sabanera, Parque Monagas, and La Virgencita subpopulations (USFWS 2018, entire). An analysis of high-resolution aerial images from these sites following Hurricane María shows extensive damage and modification to the forest structure with subpopulations in southern Puerto Rico exposed to less wind damage (Hu and Smith 2018, pp. 1, 17). When comparing affected subpopulation abundance, the evidence of direct impacts to palo de rosa individuals due to Hurricane María appear to be discountable. However, this post-hurricane assessment focused on previously surveyed robust subpopulations (USFWS 2018, entire). Overall, the subpopulations along the northern coast of Puerto Rico suffered severe defoliation with trees showing mortality of the crown apex, but some trees showed regrowth 6 months post-hurricane (USFWS 2018, entire).

Hurricane damage extends beyond the direct impacts to individual palo de rosa trees. As mentioned above, the subpopulations along the northern coast of Puerto Rico are severely fragmented due to prior land-use history. Disturbance and edge effects associated with urban development and infrastructure corridors may promote the establishment and spread of invasive, nonnative plant species, and lianas (woody vines) typical of early or intermediate successional stages, which may result in rare and endemic plant species being outcompeted (Hansen and Clevenger 2005, p. 249; Madeira et al. 2009, p. 291). Hurricanes may not introduce nonnative species to the forest structure, but they can promote favorable conditions for these species and, therefore, increase the relative abundance of nonnatives.

Habitat intrusion by exotics is positively correlated to the distance of the disturbance gap (Hansen and Clevenger 2005, p. 249). Thus, the adverse effects from human-induced habitat disturbance ( e.g., deforestation and urban development) can be exacerbated by hurricanes by creating or increasing this disturbance gap. A post-hurricane assessment provided evidence that all palo de rosa subpopulations along the north coast of Puerto Rico showed habitat intrusion by weedy vines ( e.g., Dioscorea alata (ñame), Thunbergia grandiflora (pompeya), Cissus erosa (caro de tres hojas), and Cayaponia americana (bejuco de torero)) following Hurricane María (USFWS 2018, entire).

In the same assessment, weedy vegetation and vines densely covered an area in the Hacienda Esperanza subpopulation where the palo de rosa occurs at a low-elevation mogote and the Hacienda Sabanera where the habitat that harbors the palo de rosa subpopulation was cut to the edge due to urban development (USFWS 2018, pp. 8-18). Examination of aerial images of the habitat shows a flattened forest structure indicative of hurricane damage with standing trees missing main branches and canopy. Competition with nonnative species and weedy vines for necessary resources (space, light, water, nutrients) may reduce natural recruitment by inhibiting germination and outcompeting seedlings of native species (Rojas-Sandoval and Meléndez-Ackerman 2013, p. 11; Thomson 2005, p. 615). The palo de rosa seedlings at Hacienda Esperanza were covered (and outcompeted) by weedy vines following Hurricane María (USFWS 2018, p. 8). At Fort Buchanan, 6 months after Hurricane María, the vegetation at the base of the mogote on that property was overgrown and dominated by weedy species. However, weedy vegetation had not reached palo de rosa individuals at the top of the mogote, and there was little evidence of adverse impacts to seedlings and saplings due to competition with exotics (USFWS 2018, p. 8).

The GCF palo de rosa subpopulations are surrounded by a large tract of intact native forest providing a buffer zone that precludes habitat invasion by exotics. Despite the overall evidence of canopy opening and some impacts to palo de rosa individuals due to Hurricane María, there was no evidence of habitat intrusion by exotics at Cañon Las Trichilias and Cañon Hoya Honda (USFWS 2018 pp. 3-8), which highlights the importance of maintaining native forested habitat that provides a buffer for palo de rosa subpopulations.

The above discussion indicates that the potential adverse impacts due to hurricanes and the associated habitat intrusion by exotic plant species are variable depending on habitat fragmentation, topography, distance to disturbance, and the size of the subpopulation. It further highlights the importance of having healthy populations with robust numbers of individuals and a stratified population structure ( i.e., seedlings, saplings, and adults) to allow for recovery following hurricanes and associated habitat disturbance.

Regarding the effects of climate change, the Intergovernmental Panel on Climate Change (IPCC) concluded that warming of the climate system is unequivocal (IPCC 2014, p. 3). Observed effects associated with climate change include widespread changes in precipitation amounts and aspects of extreme weather, including droughts, heavy precipitation, heat waves, and the intensity of tropical cyclones (IPCC 2014, p. 4). Rather than assessing climate change as a single threat in and of itself, we examined the potential effects to the species and its habitat that arise from changes in environmental conditions associated with various aspects of climate change.

We examined a downscaled model for Puerto Rico based on three IPCC global emissions scenarios from the CMIP3 data set—mid-high (A2), mid-low (A1B), and low (B1)—as the CMIP5 data set was not available for Puerto Rico at that time (Coupled Model Intercomparison Project; Khalyani et al. 2016, pp. 267, 279-280). These scenarios are generally comparable and span the more recent representative concentration pathways (RCP) scenarios from RCP 4.5 (B1) to RCP 8.5 (A2) (IPCC 2014, p. 57). The B1 and A2 scenarios encompass the projections and effects of the A1B scenario; we will describe our analyses for the B1 (RCP 4.5) and A2 (RCP 8.5) scenarios and recognize the A1B (RCP 6.0) projections and effects that fall into this range.

The modelling of climate projections expected in Puerto Rico in our analysis extends to 2100. We acknowledge inherent divergence in climate projections based on the model chosen with uncertainty increasing later in the century (Khalyani et al. 2016, p. 275). However, we assessed the climate changes expected in the year 2070, a 50-year timeframe representing the foreseeable future for the palo de rosa (as described in Regulatory Framework, above). Under the RCP 4.5 and 8.5 scenarios, precipitation declines while temperature and total dry days increase resulting in extreme drought conditions that would result in the conversion of subtropical dry forest into dry and very dry forest (Khalyani et al. 2016, p. 280). Downscaled future climate change scenarios indicate that by 2070, Puerto Rico is predicted to experience a decrease in rainfall along with increased drought intensity under RCP 4.5 and 8.5 (Khalyani et al. 2016, p. 265; Bhardwaj et al. 2018, p. 133; U.S. Global Change Research Program 2018, 20:820). The western region of Puerto Rico has already experienced negative trends in annual rainfall (PRCCC 2013, p. 7).

Temperatures are also expected to rise between 2020 and 2070. Under RCP 4.5, a mean temperature increase of 4.6-5.4 degrees Celsius (°C) (40.3-41.7 degrees Fahrenheit (°F)) is projected, and an increase of 7.5-9 °C (45.5-48.2 °F) is projected under RCP 8.5 (Khalyani et al. 2016, p. 275). Precipitation decreases influenced by warming will tend to accelerate the hydrological cycles resulting in wet and dry extremes (Jennings et al. 2014, p. 4; Cashman et al. 2010, p. 1). Downscaled general circulation models predict dramatic shifts in the life zones of Puerto Rico with potential loss of subtropical rain, moist, and wet forests, and the appearance of tropical dry and very dry forests are anticipated under both RCP 4.5 and 8.5 scenarios (Khalyani et al. 2016, p. 275). Nonetheless, such predicted changes in life zones may not severely affect the palo de rosa due to its distribution throughout Puerto Rico, which includes different life zones and habitat types.

Vulnerability to climate change impacts is a function of sensitivity to those changes, exposure to those changes, and adaptive capacity (IPCC 2007, p. 89; Glick and Stein 2010, p. 19). As described earlier, the palo de rosa is a species with low recruitment and seed dispersal limited to gravity diminishing its potential to reach areas with suitable microhabitat conditions for establishment. Despite the evidence of multiple reproductive events (fruit production) in one subpopulation, low recruitment of saplings and a population structure dominated by adult trees could be the result of mortality and thinning of individuals at the seedling stage due to drought stress. The projected prolonged droughts expected with climate change may affect the phenology of the palo de rosa resulting in the loss of developing flowers and fruits or reduce the viability of the few produced seeds reducing the likelihood of natural recruitment. In addition, hurricanes followed by extended periods of drought caused by climate change may result in microclimate alterations that could allow other plants (native or nonnative) to become established and invasive (Lugo 2000, p. 246), which would preclude the recruitment of palo de rosa seedlings.

Based on the distribution of the palo de rosa and its habitat, we have determined that conditions associated with climate change could impact this species. Climate change is almost certain to affect terrestrial habitats and the palo de rosa; however, the future extent and timing of those effects beyond the foreseeable future is uncertain. Some terrestrial plant populations are able to adapt and respond to changing climatic conditions (Franks et al. 2013, entire), but the palo de rosa's ability to do so is unknown. A sound, long-term monitoring of known palo de rosa populations is needed to understand the effects on the species' viability.

In summary, other natural and manmade factors, such as hurricanes and related threats due to habitat fragmentation, edge habitat, habitat intrusion by exotic plant species, and the low recruitment and limited dispersal of the palo de rosa, are current threats to the species. Hurricanes and post-hurricane habitat encroachment and nonnative plant invasion have affected subpopulations along the northern coast of Puerto Rico (USFWS 2018, entire). Invasive species can preclude the establishment of new palo de rosa individuals through competition for sunlight, nutrients, water, and space to grow. Although climate change is almost certain to affect terrestrial habitats, there is uncertainty about how predicted future changes in temperature, precipitation, and other factors will influence the palo de rosa.

At the time of listing (55 FR 13488, April 10, 1990), we considered small population size as a threat affecting the continued survival of the palo de rosa based on the species' limited distribution and low number of individuals ( i.e., only nine individuals throughout the species' range in Puerto Rico). Based on this information, we considered the risk of extinction of the palo de rosa very high. New distribution and abundance information available since the species was listed reflects that the palo de rosa is more abundant and widely distributed than previously thought (USFWS 2017, entire); thus, we no longer consider limited distribution as an imminent threat to this species. However, at least 37 (56 percent) of the known subpopulations are composed of 10 or fewer individuals. The effect of small population size exacerbates other threats and makes these subpopulations vulnerable to extirpation by stochastic and catastrophic events.

We have carefully assessed the best scientific and commercial information available regarding the threats faced by the palo de rosa in developing this rule. Limited distribution and a low number of individuals were considered a threat to the palo de rosa when we listed the species (55 FR 13488, April 10, 1990), but recent information indicates the species is more abundant and widely distributed than known at the time of listing. However, other threats are still affecting the palo de rosa. Based on the analysis above, although we no longer consider limited distribution as an imminent threat to this species, we conclude that habitat destruction and modification on privately owned lands (particularly along the northern coast of Puerto Rico) and other natural or manmade factors ( e.g., hurricanes, habitat fragmentation resulting in lack of connectivity between individuals, and habitat encroachment by invasive species), while greatly reduced, continue to threaten palo de rosa populations. In addition, low recruitment related to sporadic flowering and fruit production and the slow growth of seedlings under close canopy conditions ( e.g., species reproductive biology and ecology) coupled with the threats discussed above are expected to remain threats to the palo de rosa.

It is also expected that the palo de rosa will be affected by climate change within the foreseeable future, particularly by generalized changes in precipitation and drought conditions. Climate change is expected to result in more intense hurricanes and extended periods of drought. Increased hurricanes are expected to cause direct mortality of adult trees downed due to high winds whereas more intense drought conditions are expected to reduce the species' reproductive output (reduced flowering and fruiting events) and preclude seedling and sapling recruitment. However, based on the best available data, we do not consider climate change to represent a current or an imminent threat to this species across its range.

Species viability, or the species' ability to sustain populations over time, is related to the species' ability to withstand catastrophic population- and species-level events (redundancy) to adapt to novel changes in its biological and physical environment (representation) and to withstand environmental and demographic stochasticity and disturbances (resiliency). The viability of a species is also dependent on the likelihood of new stressors or continued threats, now and in the future, that act to reduce a species' redundancy, representation, and resiliency. A highly resilient palo de rosa population should be characterized by sufficient abundance and connectivity between reproductive individuals to allow for reproductive events and cross-pollination, an age class structure representative of recruitment greater than mortality, multiple subpopulations within the population, and the availability of high-quality habitat to allow for recruitment. High representation for the species is characterized by multiple populations occurring within a wide range of environmental conditions ( e.g., substrate and precipitation) that allow for sufficient genetic variability. Multiple resilient populations across the range of the species characterize high redundancy for the palo de rosa.

We evaluated the biological status of the palo de rosa both currently and into the future considering the species' viability as characterized by its resiliency, redundancy, and representation. Based on the analysis of available herbarium specimens, we have determined the species' distribution and abundance was once more common and widespread and likely was a dominant late-successional species of coastal to middle elevation (500 m (1,640 ft)) habitats and even extended to coastal valleys and sand dunes (Monsegur-Rivera 2019, pers. obs.).

The current known palo de rosa subpopulations are remnants of the species' historical distribution persisting on areas of low agricultural value ( e.g., top of the mogotes ) that were affected by deforestation for charcoal production as evidenced by individuals with multiple trunks of palo de rosa sprouting from the same base. Based on the available information on the palo de rosa's natural distribution at the time of listing as well as considering that 40 of the known 66 subpopulations currently show no recruitment and that no subpopulations appear to be expanding due to natural dispersal, palo de rosa populations exhibit reduced resiliency. No subpopulations appear to be dispersing, and no populations are highly resilient. None of the currently known palo de rosa subpopulations are considered a recent colonization event or natural expansion of the species within its habitat.

The species persisted through the almost entire deforestation of Puerto Rico with less than 6 percent of remaining forested habitat across the island by the 1930s (Franco et al. 1997, p. 3) when the low-elevation coastal valleys habitat of the palo de rosa was extensively deforested for agricultural practices ( e.g., sugar cane and tobacco plantations). There are broad accounts regarding the extensive deforestation and habitat modification that occurred in Puerto Rico until the 1950s (Franco et al. 1997, p. 3), which resulted in changes in forest structure and diversity, pollinators' assemblages, seed dispersers, and the prevailing microhabitat conditions in which the palo de rosa evolved. Despite the return from such deforestation, known subpopulations show a clustered and patchy distribution and are characterized by a population structure dominated by adults. Moreover, the species faces a low recruitment rate and slow growth resulting in few saplings reaching a reproductive size; in addition, the species shows minimal or no dispersal (limited to gravity). Based on our observations, it has taken about 60 years from the peak of deforestation (1930s) for the palo de rosa to show some initial evidence of recruitment.

We consider that the palo de rosa has limited redundancy as it is known from multiple subpopulations (66) throughout its geographical range representing 14 natural populations distributed throughout the southern and northern coasts of Puerto Rico. Nonetheless, about 37 (56 percent) of the known subpopulations are composed of 10 or fewer individuals and show little or no recruitment and, thus, reduced resiliency. As described above, the species faces a low recruitment rate, slow growth and limited dispersal, and patchy and small subpopulations resulting in an increased vulnerability to extirpation of these subpopulations. All of these characteristics are limiting factors and make the species vulnerable to catastrophic and stochastic events, such as hurricanes and droughts, that can cause local extirpations. The best available information indicates that the palo de rosa is not naturally expanding into or colonizing habitats outside the areas where it is known to occur.

In terms of the representation of the palo de rosa, we have no data on its genetic variability. Although the species occurs in a wide range of habitats and environmental conditions, it has a fragmented distribution, scattered (sporadic) flowering events, and a low recruitment rate. Thus, little or no genetic exchange is thought to occur between extant subpopulations likely resulting in outbreeding depression, which may explain the lack of effective reproduction and recruitment (Frankham et al. 2011, p. 466). The low recruitment rate results in little transfer of genetic variability into future generations, limits the expansion of the species outside its current locations, and limits its ability to adapt to changing environmental conditions. For example, the loss or reduction of connectivity between subpopulations in areas like Arecibo-Vega Baja, Dorado, La Virgencita, Mogotes de Nevares, and San Juan-Fajardo can be detrimental to the long-term viability of the species as it affects cross-pollination and, therefore, gene flow. In fact, the only populations that occur entirely within native forest areas managed for conservation are GCF and SCF. This continued protected habitat provides for an effective cross-pollination (gene flow) that can secure the long-term viability of the species. However, the overall representation of the palo de rosa is reduced as the GCF and SCF populations are restricted to the southern coast, and the genetic representation of the palo de rosa in the northern karst area, a different ecological environment, is vulnerable because that habitat is threatened by destruction or modification.

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 threatened species. 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 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 endangered species or threatened species based on one or more 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.

After evaluating threats to the species and assessing the cumulative effect of the threats under the section 4(a)(1) factors, we have determined that the palo de rosa's current viability is higher than was known at the time of listing (population current estimate of 1,144 individuals in 66 subpopulations) based on the best available information. The increase in the number of known individuals and new localities reflects increased survey efforts but does not necessarily indicate that previously known populations are naturally expanding their range. The number of palo de rosa individuals has changed from 9 individuals in protected lands at the time of listing to 407 individuals (32 percent of subpopulations) occurring in areas managed for conservation ( e.g., Commonwealth Forest and Federal lands). Furthermore, 396 individuals (38 percent of subpopulations) occur in areas subject to little habitat modification due to the steep topography in the northern karst region of Puerto Rico. The remaining 30 percent of the subpopulations (containing approximately 341 individuals) occur within areas severely encroached upon by and vulnerable to urban or infrastructure development. Nonetheless, habitat destruction and modification on privately owned lands (particularly along the northern coast of Puerto Rico) and other natural or manmade factors (such as hurricanes, habitat fragmentation, lack of connectivity between populations, habitat intrusion by invasive species, and the species' reproductive biology) continue to threaten the viability of the palo de rosa.

Although population numbers and abundance of the palo de rosa have increased and some identified threats have decreased, our analysis indicates that threats remain. After assessing the best available information, we conclude that the palo de rosa no longer meets the Act's definition of an endangered species throughout all of its range. We therefore proceed with determining whether the palo de rosa meets the Act's definition of a threatened species ( i.e., is likely to become endangered within the foreseeable future) throughout all of its range.

In terms of habitat destruction and modification, we can reasonably determine that 70 percent of subpopulations (71 percent of individuals) are not expected to be substantially affected by habitat destruction and modification in the foreseeable future. This majority occurs within protected lands managed for conservation (36 percent of the known individuals or 32 percent of subpopulations) or on private lands with low probability of modification due to steep topography (35 percent of the known individuals or 38 percent of subpopulations). However, for the 30 percent of subpopulations (30 percent of the known individuals) occurring in areas severely encroached upon by and vulnerable to urban or infrastructure development now and into the future, we are reasonably certain these subpopulations will continue to have a lower resiliency (due to reduced connectivity (cross-pollination) and lack of recruitment) and, in some cases, may experience the loss of individuals or subpopulations adjacent to critical infrastructure such as highways or other development within the foreseeable future ( e.g., Hacienda Sabanera, PR-2 and PR-22 maintenance and expansion, Islote Ward extirpation).

We have evidence that some populations are showing signs of reproduction and recruitment. However, due to the slow growth of the species it may take several decades to ensure these recruitment events effectively contribute to a population's resiliency (new individuals reach a reproductive size). Despite no longer considering limited distribution as an imminent threat to this species, we have identified factors associated with habitat modification and other natural or manmade factors that still have some impacts on the palo de rosa and affect the species' viability and effective natural recruitment. The species still faces dispersal problems, and the recruitment is still limited to the proximity of parent trees; we have no evidence of a palo de rosa population that is the result of a recent colonization event or a significant population expansion. This renders the known subpopulations vulnerable to adverse effects related to habitat fragmentation and lack of connectivity, which may preclude future recruitment and the population's resiliency.

In addition, despite the presence of regulations protecting the species both on public and private lands, the protection of palo de rosa trees on private lands remains challenging. Habitat modifications and fragmentation continue to occur on private lands, which can increase the likelihood of habitat intrusion by exotic plants and human-induced fires and reduce connectivity between populations (affecting cross-pollinations) and the availability of suitable habitat for the natural recruitment of the species. Still, none of these is an imminent threat to the species at a magnitude such that the taxon warrants endangered status across its range. Thus, after assessing the best available information, we conclude that the palo de rosa is not currently in danger of extinction but likely to become in danger of extinction 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 in the foreseeable future throughout all or a significant portion of its range. The court in Center for Biological Diversity v. Everson, 2020 WL 437289 (D.D.C. Jan. 28, 2020) ( Center for Biological Diversity ) vacated the aspect 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) that provided that the Services do not undertake an analysis of significant portions of a species' range if the species warrants listing as threatened throughout all of its range. Therefore, we proceed to evaluating whether the species is endangered 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 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.

Following the court's holding in Center for Biological Diversity, we now consider whether there are any significant portions of the species' range where the species is in danger of extinction now ( i.e., endangered). In undertaking this analysis for the palo de rosa, we choose to address the status question first—we consider information pertaining to the geographic distribution of both the species and the threats that the species faces to identify any portions of the range where the species may be endangered. Kinds of threats and levels of threats are more likely to vary across a species' range if the species has a large range rather than a very small natural range, such as the palo de rosa. Species with limited ranges are more likely to experience the same kinds and generally the same levels of threats in all parts of their range.

For the palo de rosa, we considered whether the threats are geographically concentrated in any portion of the species' range at a biologically meaningful scale in the context of its small natural range or if the status of the species differs in a portion of the range due to other factors. We examined the following threats: habitat destruction, fragmentation, and modification; invasive species; hurricanes; and the effects of climate change, including cumulative effects. We have identified habitat destruction and modification as threatening known populations in three of the five areas along the southern coast of Puerto Rico and eight of nine populations along the northern coast of Puerto Rico, particularly on privately owned lands throughout the range of the species. In addition, habitat destruction and modification are occurring within the species' range in Hispaniola. Habitat encroachment by invasive plant species and habitat fragmentation caused by harvesting of timber for fence posts and maintaining rights-of-way are also considered to be further stressors to the viability of the palo de rosa across its range. Changes in climatic conditions are expected to result in more intense hurricanes and extended periods of drought under RCPs 4.5 and 8.5, but the effect of these changes on the palo de rosa is unknown. The expected changes in climatic conditions will affect all palo de rosa populations uniformly across the range of the species. Lastly, palo de rosa populations across the range experience low recruitment rates, slow growth, and limited dispersal.

Overall, the threats to palo de rosa viability affect the species similarly across the range of the species. We found no concentration of threats and no other factors in any portion of the palo de rosa's range at a biologically meaningful scale that place the palo de rosa in that geographic area in danger of extinction. Thus, there are no portions of the species' range where the species has a different status from its rangewide status. Therefore, no portion of the species' range provides a basis for determining that the species is in danger of extinction in a significant portion of its range; however, we determine that the species is likely to become endangered within the foreseeable future throughout all of its range. This is consistent with the courts' holdings in Desert Survivors v. Department of the Interior, No. 16-cv-01165-JCS, 2018 WL 4053447 (N.D. Cal. Aug. 24, 2018), and Center for Biological Diversity v. Jewell, 248 F. Supp. 3d 946, 959 (D. Ariz. 2017).

Our review of the best available scientific and commercial information indicates that the palo de rosa meets the Act's definition of a threatened species. Therefore, we are reclassifying the palo de rosa as a threatened species in accordance with sections 3(20) and 4(a)(1) of the Act.

Section 4(d) of the Act contains two sentences. The first sentence states that the Secretary shall issue such regulations as she deems necessary and advisable to provide for the conservation of species listed as threatened. The U.S. Supreme Court has noted that statutory language like “necessary and advisable” demonstrates a large degree of deference to the agency (see Webster v. Doe, 486 U.S. 592 (1988)). Conservation is defined in the Act to mean the use of all methods and procedures that are necessary to bring any endangered species or threatened species to the point at which the measures provided pursuant to the Act are no longer necessary. Additionally, the second sentence of section 4(d) of the Act states that the Secretary may by regulation prohibit with respect to any threatened species any act prohibited under section 9(a)(1), in the case of fish or wildlife, or 9(a)(2), in the case of plants. Thus, the combination of the two sentences of section 4(d) provides the Secretary with wide latitude of discretion to select and promulgate appropriate regulations tailored to the specific conservation needs of the threatened species. The second sentence grants particularly broad discretion to the Service when adopting the prohibitions under section 9 of the Act.

The courts have recognized the extent of the Secretary's discretion under this standard to develop rules that are appropriate for the conservation of a species. For example, courts have upheld rules developed under section 4(d) as a valid exercise of agency authority where they prohibited take of threatened wildlife or include a limited taking prohibition (see Alsea Valley Alliance v. Lautenbacher, 2007 U.S. Dist. Lexis 60203 (D. Or. 2007); Washington Environmental Council v. National Marine Fisheries Service, 2002 U.S. Dist. Lexis 5432 (W.D. Wash. 2002)). Courts have also upheld 4(d) rules that do not address all of the threats a species faces (see State of Louisiana v. Verity, 853 F.2d 322 (5th Cir. 1988)). As noted in the legislative history when the Act was initially enacted, “once an animal is on the threatened list, the Secretary has an almost infinite number of options available to [her]with regard to the permitted activities for those species. [She] may, for example, permit taking, but not importation of such species, or [she] may choose to forbid both taking and importation but allow the transportation of such species” (H.R. Rep. No. 412, 93rd Cong., 1st Sess. 1973).

In the early days of the Act, the Service published at 50 CFR 17.71 a general protective regulation that would apply to each threatened plant species, unless we were to promulgate a separate species-specific protective regulation for that species. In the wake of the court's CBD v. Haaland decision vacating a 2019 regulation that had made 50 CFR 17.71 inapplicable to any species listed as a threatened species after the effective date of the 2019 regulation, the general protective regulation applies to all threatened species, unless we adopt a species-specific protective regulation. As explained below, we are adopting a species-specific rule that sets out all of the protections and prohibitions applicable to palo de rosa.

Exercising the Secretary's authority under section 4(d) of the Act, we have developed a species-specific rule that is designed to address the palo de rosa's specific threats and conservation needs. As discussed above under Summary of Biological Status and Threats, we have concluded that the palo de rosa is likely to become endangered within the foreseeable future primarily due to habitat destruction and modification, particularly by urban development, right-of-way maintenance, rock quarries, and grazing. Additionally, other natural or manmade factors like hurricanes, invasive species, and landslides still threaten the species. The provisions of this 4(d) rule promote conservation of the palo de rosa by encouraging conservation programs for the species and its habitat and promoting additional research to inform future habitat management and recovery actions for the species. Section 4(d) requires the Secretary to issue such regulations as she deems necessary and advisable to provide for the conservation of each threatened species and authorizes the Secretary to include among those protective regulations any of the prohibitions that section 9(a)(2) of the Act prescribes for endangered species. Our current regulations at 50 CFR 17.71 apply many of the prohibitions in section 9(a)(2) of the Act to all threatened plants, as clarified at 50 CFR 17.61. However, if we promulgate species-specific protective regulations for a given species, the species-specific regulations replace 50 CFR 17.71. We find that the protections, prohibitions, and exceptions in this rule as a whole satisfy the requirement in section 4(d) of the Act to issue regulations deemed necessary and advisable to provide for the conservation of the palo de rosa.

The protective regulations we are proposing for palo de rosa incorporate prohibitions from section 9(a)(2) to address the threats to the species. Section 9(a)(2) prohibits the following activities for endangered plants: importing or exporting; certain acts related to removing, damaging, and destroying; delivering, receiving, carrying, transporting, or shipping in interstate or foreign commerce in the course of commercial activity; or selling or offering for sale in interstate or foreign commerce.

As discussed above under Summary of Biological Status and Threats, the present or threatened destruction, modification, or curtailment of the species' habitat or range (specifically, urban development, maintenance of power lines and associated rights-of-way, infrastructure development, rock quarries, grazing by cattle, and extraction of fence posts), inadequacy of existing regulatory mechanisms, and other natural or manmade factors affecting the species' continued existence (specifically, hurricanes, invasive plant species, landslides, and habitat fragmentation and lack of connectivity between subpopulations) are affecting the status of the palo de rosa. A range of activities have the potential to impact this plant, including recreational and commercial activities. Regulating these activities will help preserve the species' remaining populations, slow their rate of potential decline, and decrease synergistic, negative effects from other stressors. As a whole, the regulation would help in the efforts to recover the species.

Despite these prohibitions regarding threatened species, we may under certain circumstances issue permits to carry out one or more otherwise-prohibited activities, including those described above. The regulations that govern permits for threatened plants state that the Director may issue a permit authorizing any activity otherwise prohibited with regard to threatened species (50 CFR 17.72). Those regulations also state that the permit shall be governed by the provisions of § 17.72 unless a special rule applicable to the plant is provided in §§ 17.73 to 17.78. Therefore, permits for threatened species are governed by the provisions of § 17.72 unless a species-specific 4(d) rule provides otherwise. We note that, although our recent revisions to § 17.71 had made the prohibitions in § 17.71(a) inapplicable to any plant listed as a threatened species after September 26, 2019, the general protective regulation at 50 CFR 17.71 now applies because of the court's decision vacating the 2019 regulations. We anticipate that permitting provisions would generally be similar or identical for most species, so applying the provisions of § 17.72 unless a species-specific 4(d) rule provides otherwise would likely avoid substantial duplication. Under 50 CFR 17.72 with regard to threatened plants, a permit may be issued for the following purposes: for scientific purposes, to enhance propagation or survival, for economic hardship, for botanical or horticultural exhibition, for educational purposes, or for other purposes consistent with the purposes and policy of the Act. Additional statutory exemptions from the prohibitions are found in sections 9 and 10 of the Act.

We recognize the special and unique relationship with our State and Territorial natural resource agency partners in contributing to conservation of listed species. State and Territorial agencies often possess scientific data and valuable expertise on the status and distribution of endangered, threatened, and candidate species of wildlife and plants. State and Territorial agencies, because of their authorities and their close working relationships with local governments and landowners, are in a unique position to assist the Services in implementing all aspects of the Act. In this regard, section 6 of the Act provides that the Services shall cooperate to the maximum extent practicable with the States in carrying out programs authorized by the Act. Therefore, any qualified employee or agent of a State conservation agency that is a party to a cooperative agreement with the Service in accordance with section 6(c) of the Act, who is designated by his or her agency for such purposes, would be able to conduct activities designed to conserve the palo de rosa that may result in otherwise prohibited activities without additional authorization.

Once the palo de rosa was federally listed, legal protection was extended by virtue of an existing cooperative agreement (under section 6 of the Act) with the Commonwealth of Puerto Rico. Therefore, this provision will work in concert with the cooperative agreement to ensure that conservation actions conducted by employees or agents of the Commonwealth are not prohibited.

We also recognize the beneficial and educational aspects of activities with seeds of cultivated plants, which generally enhance the propagation of the species and, therefore, would satisfy permit requirements under the Act. We intend to monitor the interstate and foreign commerce and import and export of these specimens in a manner that will not inhibit such activities providing the activities do not represent a threat to the survival of the species in the wild. In this regard, seeds of cultivated specimens would not be regulated provided a statement that the seeds are of “cultivated origin” accompanies the seeds or their container.

Nothing in this 4(d) rule would change in any way the recovery planning provisions of section 4(f) of the Act, the consultation requirements under section 7 of the Act, or our ability to enter into partnerships for the management and protection of the palo de rosa. However, interagency cooperation may be further streamlined through planned programmatic consultations for the species between us and other Federal agencies, where appropriate.

We have determined that environmental assessments and environmental impact statements, as defined in the National Environmental Policy Act of 1969 ( 42 U.S.C. 4321 et seq. ), need not be prepared in connection with determining a species' listing status under the Endangered Species Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244). We also determine that 4(d) rules that accompany regulations adopted pursuant to section 4(a) of the Act are not subject to the National Environmental Policy Act.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), E.O. 13175, and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial 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 have determined that there are no Tribal lands affected by this rule.

A complete list of references cited is available on https://www.regulations.gov under Docket Number FWS-R4-ES-2020-0059 and upon request form the Caribbean Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT ).

The primary authors of this document are staff members of the Caribbean Ecological Services Field Office.

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

The reef fish fishery of the Gulf is managed under the Fishery Management Plan (FMP) for Reef Fish Resources of the Gulf of Mexico (Reef Fish FMP), prepared by the Gulf of Mexico Fishery Management Council (Gulf Council). The CMP fishery is managed under the FMP for CMP Resources in the Gulf of Mexico and Atlantic Region, prepared by the Gulf Council and South Atlantic Fishery Management Council (South Atlantic Council). These FMPs are implemented through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

Amendment 26 to the Reef Fish FMP established an IFQ program for the commercial red snapper component of the Gulf reef fish fishery (71 FR 67447, November 22, 2006). Amendment 29 to the Reef Fish FMP established an IFQ program for the commercial grouper and tilefish components of the Gulf reef fish fishery (74 FR 44732, August 31, 2009). Regulations implementing these IFQ programs (50 CFR 622.21 and 622.22) require that IFQ participants have access to a computer and the internet and that they conduct administrative functions associated with the IFQ program, e.g., landing transactions, online. However, these regulations also specify that during catastrophic conditions, as determined by the RA, the RA may authorize IFQ participants to use paper-based forms to complete administrative functions for the duration of the catastrophic conditions. The RA must determine that catastrophic conditions exist, specify the duration of the catastrophic conditions, and specify which participants or geographic areas are deemed affected.

The Generic Dealer Amendment established Federal dealer reporting requirements for federally permitted dealers in the Gulf and South Atlantic (79 FR 19490, April 9, 2014). The Gulf For-Hire Reporting Amendment implemented reporting requirements for Gulf reef fish and CMP owners and operators of Gulf for-hire vessels (85 FR 44005, July 21, 2020). Regulations implementing these Gulf dealer reporting requirements (50 CFR 622.5) and for-hire vessel reporting requirements (50 CFR 622.26 and 622.374) state that dealers must submit electronic reports and that Gulf reef fish and CMP vessels with the applicable charter vessel/headboat permit must submit electronic fishing reports of all fish harvested and discarded. However, these regulations also specify that during catastrophic conditions, as determined by the RA, the RA may waive or modify the reporting time requirements for dealers and for-hire vessels for the duration of the catastrophic conditions.

Hurricane Ian made landfall in the U.S. near Cayo Costa, Florida, in the Gulf as a Category 4 hurricane on September 28, 2022, then moved across the Florida peninsula into the South Atlantic and made another U.S. landfall as a Category 1 hurricane near Georgetown, South Carolina, on September 30, 2022. Strong winds and flooding from this hurricane impacted communities throughout coastal Florida and coastal South Carolina. This resulted in power outages and damage to homes, businesses, and infrastructure. As a result, the RA has determined that catastrophic conditions continue to exist in the Gulf for the Florida counties of Charlotte, Collier, and Lee.

The RA previously authorized Federal dealers and Federal for-hire operators in these affected areas to delay reporting of trip tickets and for-hire logbooks to NMFS, and IFQ participants in this affected area to use paper-based forms, from October 6, 2022, through November 7, 2022 (87 FR 61540, October 12, 2022). As stated in that temporary rule, NMFS continues to monitor the conditions in these areas.

NMFS has received numerous reports of continued damage to the infrastructure in the Florida counties of Charlotte, Collier, and Lee, on the Gulf coast of Florida, such as power outages and interruption of water service. Therefore, to provide Federal dealers and Federal for-hire operators in the affected area the continued flexibility to delay reporting of trip tickets and for-hire logbooks to NMFS, and allow IFQ participants in the affected area to use paper-based forms, NMFS extends the current catastrophic conditions determination through December 5, 2022. This determination remains in effect for Charlotte, Collier, and Lee counties in Florida.

Through this temporary rule, the RA is authorizing Federal dealers and Federal for-hire operators in these affected areas to delay reporting of trip tickets and for-hire logbooks to NMFS, and authorizing IFQ participants in this affected area to use paper-based forms, from November 8, 2022, through December 5, 2022. NMFS will provide additional notification to affected dealers via NOAA Weather Radio, Fishery Bulletins, and other appropriate means. NMFS will continue to monitor and re-evaluate the areas and duration of the catastrophic conditions, as necessary.

Dealers may delay electronic reporting of trip tickets to NMFS during catastrophic conditions. Dealers are to report all landings to NMFS as soon as possible. Assistance for Federal dealers in affected area is available from the NMFS Fisheries Monitoring Branch at 1-305-361-4581. NMFS previously provided IFQ dealers with the necessary paper forms and instructions for submission in the event of catastrophic conditions. Paper forms are also available from the RA upon request. The electronic systems for submitting information to NMFS will continue to be available to all dealers, and dealers in the affected area are encouraged to continue using these systems, if accessible.

Federal for-hire operators may delay electronic reporting of logbooks to NMFS during catastrophic conditions. Federal for-hire operators are to report all landings to NMFS as soon as possible. Assistance for Federal for-hire operators in affected area is available from the NMFS Southeast For-Hire Integrated Electronic Reporting Program at 1-833-707-1632, Monday through Friday, between 8 a.m. and 4:30 p.m., Eastern Time. The electronic systems for submitting information to NMFS will continue to be available to all Federal for-hire operators, and for-hire operators are encouraged to continue using the these systems, if accessible.

The administrative program functions available to IFQ participants in the area affected by catastrophic conditions will be limited under the paper-based system. There will be no mechanism for transfers of IFQ shares or allocation under the paper-based system in effect during catastrophic conditions. Assistance in complying with the requirements of the paper-based system will be available via the NMFS Catch Share Support line, 1-866-425-7627 Monday through Friday, between 8 a.m. and 4:30 p.m., Eastern Time.

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is consistent with the regulations in 50 CFR 622.5(c)(1)(iii), 622.21(a)(3)(iii), and 622.22(a)(3)(iii), which were issued pursuant to section 304(b) of the Magnuson-Stevens Act, and are exempt from review under Executive Order 12866.

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment are unnecessary and contrary to the public interest. Such procedures are unnecessary because the final rules implementing the Gulf IFQ programs, the Gulf and South Atlantic Federal dealer reporting requirements, and the Gulf for-hire vessel reporting requirements have already been subject to notice and public comment. These rules authorize the RA to determine when catastrophic conditions exist, and which participants or geographic areas are deemed affected by catastrophic conditions. The final rules also authorize the RA to provide timely notice to affected participants via publication of notification in the Federal Register , NOAA Weather Radio, Fishery Bulletins, and other appropriate means. All that remains is to notify the public that catastrophic conditions exist, that IFQ participants may use paper forms, and that Federal dealers and Gulf for-hire permit holders may submit delayed reports. Such procedures are also contrary to the public interest because of the need to immediately implement this action because affected dealers continue to receive these species in the affected area and need a means of completing their landing transactions. With the power outages and damages to infrastructure that have occurred in the affected area due to Hurricane Ian, numerous businesses are unable to complete landings transactions, fishing reports, and dealer reports electronically. In order to continue with their businesses, IFQ participants need to be aware they can report using the paper forms, and Federal dealers and Gulf for-permit holders need to be aware that they can delay reporting.

For the aforementioned reasons, there is good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).

The 2022 annual management measures for ocean salmon fisheries (87 FR 29690, May 16, 2022) announced management measures for the commercial and recreational fisheries in the area from the U.S./Canada border to the U.S./Mexico border, effective from 0001 hours Pacific Daylight Time (PDT), May 16, 2022, until the effective date of the 2023 management measures, as published in the Federal Register . NMFS is authorized to implement inseason management actions to modify fishing seasons and quotas as necessary to provide fishing opportunity while meeting management objectives for the affected species (50 CFR 660.409). Inseason actions in the salmon fishery may be taken directly by NMFS (50 CFR 660.409(a)—Fixed inseason management provisions) or upon consultation with the Chairman of the Pacific Fishery Management Council (Council), and the appropriate State Directors (50 CFR 660.409(b)—Flexible inseason management provisions).

Management of the salmon fisheries is divided into two geographic areas: north of Cape Falcon (NOF) (U.S./Canada border to Cape Falcon, OR), and south of Cape Falcon (SOF) (Cape Falcon, OR, to the U.S./Mexico border). The actions described in this document affect the NOF commercial and recreational salmon fisheries, as set out under the heading Inseason Actions below.

Consultations with the Council Chairperson on these inseason actions occurred on September 13, 2022. Representatives from NMFS, Washington Department of Fish and Wildlife (WDFW), Oregon Department of Fish and Wildlife (ODFW), and Council staff participated in these consultations. The Salmon Advisory Subpanel and Salmon Technical Team (STT) were also on the calls.

These inseason actions were announced on NMFS' telephone hotline and U.S. Coast Guard radio broadcast on the date of the consultations (50 CFR 660.411(a)(2)).

Description of the action: Inseason action #46 modifies the NOF recreational salmon fishery. To cover an overage in the Columbia River subarea guideline, 600 Chinook salmon from the U.S./Canada border to Cape Alava, Washington (Neah Bay subarea) guideline is transferred to the Leadbetter Point to Cape Falcon, Oregon (Columbia River subarea), on an impact-neutral basis, which adds 390 Chinook salmon to the Columbia River subarea guideline. The adjusted Chinook salmon subarea guidelines are 5,510 for the Neah Bay subarea, and 8,090 for the Columbia River subarea. The adjusted overall north of Falcon recreational fishery Chinook salmon quota is 26,790.

Effective date: Inseason action #46 took effect on September 14, 2022, at 12:01 a.m. and remains in effect until the end of the commercial salmon season on September 30, 2022, at 11:59 p.m.

Reason and authorization for the action: Provisions for this type of inseason impact-neutral transfer of uncaught quota is specified in the 2022 ocean salmon regulations (87 FR 29690, May 16, 2022). The action was necessary to cover an overage of 253 Chinook salmon in the Columbia River subarea recreational fishery so that impacts of the fishery were consistent with preseason expectations and conservation objectives for salmon stocks managed under the jurisdiction of the Council, and to preserve season length which provides economic benefits to fishery-dependent communities.

The West Coast Regional Administrator (RA) considered the landings of Chinook salmon to date and projected catch, fishery effort occurring to date and projected effort, and quotas set preseason and determined that this inseason action was necessary to meet management goals set preseason and address the overage in the Columbia River subarea Chinook salmon catch. Modification of quotas and/or fishing seasons is authorized by 50 CFR 660.409(b)(1)(i).

Description of the action: Inseason action #47 modifies the commercial salmon troll fishery NOF landing and possession limits of 15 Chinook salmon and 225 coho salmon per vessel per landing week (Thursday through Wednesday).

Effective date: Inseason action #47 took effect on September 15, 2022, at 12:01 a.m. and remains in effect until superseded.

Reason and authorization for the action: Inseason action #47 was necessary to provide access to the available Chinook and coho salmon quota without exceeding the Chinook salmon guideline. The RA considered the landings of Chinook and coho salmon to date and projected catch, fishery effort occurring to date and projected effort, and quotas set preseason and determined that this inseason action was necessary to provide greater fishing opportunity and provide economic benefit to the fishery-dependent community while remaining consistent with conservation objectives for coho and Chinook salmon stocks managed under the Council jurisdiction. The modification of commercial landing and possession limits is authorized by 50 CFR 660.409(b)(1)(i).

All other restrictions and regulations remain in effect as announced for the 2022 ocean salmon fisheries (87 FR 29690, May 16, 2022), as modified by previous inseason action (87 FR 41260, July 12, 2022; 87 FR 49534, August 11, 2022; 87 FR 52353, August 25, 2022; 87 FR 54171, September 2, 2022; 87 FR 60105, October 4, 2022).

The RA determined that these inseason actions were warranted based on the best available information on Pacific salmon abundance forecasts, landings to date, anticipated fishery effort and projected catch, and the other factors and considerations set forth in 50 CFR 660.409. The states and tribes manage the fisheries in state waters adjacent to the areas of the U.S. exclusive economic zone (3-200 nautical miles; 5.6-370.4 kilometers) off the coasts of the states of Washington, Oregon, and California consistent with these Federal actions. As provided by the inseason notice procedures at 50 CFR 660.411, actual notice of the described regulatory actions was given, prior to the time the actions became effective, by telephone hotline numbers 206-526-6667 and 800-662-9825, and by U.S. Coast Guard Notice to Mariners broadcasts on Channel 16 VHF-FM and 2182 kHz.

NMFS issues these actions pursuant to section 305(d) of the Magnuson-Stevens Fishery Conservation and Management Act (MSA). These actions are authorized by 50 CFR 660.409, which was issued pursuant to section 304(b) of the MSA, and are exempt from review under Executive Order 12866.

Pursuant to 5 U.S.C. 553(b)(3)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest. Prior notice and opportunity for public comment on this action was impracticable because NMFS had insufficient time to provide for prior notice and the opportunity for public comment between the time Chinook and coho salmon abundance, catch, and effort information were developed and fisheries impacts were calculated, and the time the fishery modifications had to be implemented in order to ensure that fisheries are managed based on the best scientific information available and that fishery participants can take advantage of the additional fishing opportunity these changes provide. As previously noted, actual notice of the regulatory actions was provided to fishers through telephone hotline and radio notification. These actions comply with the requirements of the annual management measures for ocean salmon fisheries (87 FR 29690, May 16, 2022), the Pacific Salmon Fishery Management Plan (FMP), and regulations implementing the FMP under 50 CFR 660.409 and 660.411.

There is good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effective date, as a delay in effectiveness of this action would restrict fishing at levels inconsistent with the goals of the FMP and the current management measures.

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

The 2022 ITAC of BS “other rockfish” was established as 638 metric tons (mt), the 2022 ITAC of BS Pacific ocean perch was established as 8,799 mt, the 2022 ITAC of BS sablefish was established as 4,343 mt, and the 2022 ITAC of BSAI skates was established as 25,500 mt by the final 2022 and 2023 harvest specifications for groundfish of the BSAI (87 FR 11626, March 2, 2022). In accordance with § 679.20(a)(3) the Regional Administrator, Alaska Region, NMFS, has reviewed the most current available data and finds that the ITACs for BS “other rockfish,” BS Pacific ocean perch, BS sablefish, and BSAI skates need to be supplemented from the non-specified reserve to promote efficiency in the utilization of fishery resources in the BSAI and allow fishing operations to continue.

Therefore, in accordance with § 679.20(b)(3), NMFS apportions from the non-specified reserve of groundfish to ITACs in the BSAI management area as follows: 281 mt to BS “other rockfish,” 1,553 mt to BS Pacific ocean perch, 197 mt to BS sablefish, and 5,600 mt to BSAI skates. These apportionments are consistent with § 679.20(b)(1)(i) and do not result in overfishing of any target species because the revised ITACs and total allowable catches (TACs) are equal to or less than the specifications of the acceptable biological catch in the final 2022 and 2023 harvest specifications for groundfish in the BSAI (87 FR 11626, March 2, 2022).

The harvest specification for the 2022 ITACs and TACs included in the harvest specifications for groundfish in the BSAI are revised as follows: 919 mt for BS “other rockfish,” 10,352 mt for BS Pacific ocean perch, 4,540 mt for BS sablefish, and 31,100 mt to BSAI skates.

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

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion, and would delay the apportionment of the non-specified reserves of groundfish to the BS “other rockfish,” BS Pacific ocean perch, BS sablefish, and BSAI skates. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of October 26, 2022.

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

Under § 679.20(b)(3)(iii), interested persons are invited to submit written comments on this action (see ADDRESSES ) until November 17, 2022.

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

The 2022 TAC of Pacific ocean perch, in the WAI, allocated to vessels participating in the BSAI trawl limited access sector fishery was established as a directed fishing allowance of 196 metric tons by the final 2022 and 2023 harvest specifications for groundfish in the BSAI (87 FR 11626, March 2, 2022).

In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific ocean perch in the WAI by vessels participating in the BSAI trawl limited access section fishery. While this closure is effective, the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

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

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion, and would delay the closure of directed fishing of Pacific ocean perch in the WAI of the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of November 2, 2022.