Please refer to Docket ID NRC-2019-0160 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-2019-0160.

• 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 at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

Please include Docket ID NRC-2019-0160 in your comment submission.

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 direct final rule is limited to the changes contained in Amendment No. 14 to Certificate of Compliance No. 1014 and does not include other aspects of the Holtec International HI-STORM 100 Multipurpose Canister Cask System (HI-STORM 100 Cask 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 noncontroversial. Adequate protection of public health and safety continues to be ensured. The amendment to the rule will become effective on December 17, 2019. However, if the NRC receives significant adverse comments on this direct final rule by November 4, 2019, 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 . 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.

For detailed instructions on filing comments, please see the companion proposed rule published in the Proposed Rules section of this issue of the Federal Register .

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 “[the 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 which 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 May 1, 2000, that approved the HI-STORM 100 Cask System design and added it to the list of NRC-approved cask designs in 10 CFR 72.214 as Certificate of Compliance No. 1014 (65 FR 25241).

On October 31, 2018, as supplemented on November 6, 2018, February 28, 2019, April 5, 2019, April 23, 2019, May 13, 2019, and August 8, 2019, Holtec International submitted a request to amend Certificate of Compliance No. 1014 for the HI-STORM 100 Cask System. Amendment No. 14 revises the technical specifications to: (1) Add three new regionalized Quarter Symmetric Heat Load loading patterns for the multipurpose canister (MPC)-68M; (2) reduce the minimum cooling time to 1 year for all fuel types for storage in the MPC-68M; (3) use a damaged fuel isolator for damaged fuel stored in the MPC-68M; and (4) modify the description of the vents in the overpack in the certificate of compliance and remove the word “four” from Section 1.b describing the air inlet and outlet vents. Amendment No. 14 also makes other administrative changes to the technical specifications. The revised certificate of compliance and technical specifications are identified and evaluated in the preliminary safety evaluation report.

As documented in that preliminary safety evaluation report, the NRC performed a safety evaluation of the proposed certificate of compliance amendment request. There are no significant changes to cask design requirements in the proposed amendment.

Considering the specific design requirements for each accident condition, the design of the cask would prevent loss of containment, shielding, and criticality control in the event of an accident. The amendment does not reflect a significant change in design or fabrication of the cask. In addition, any resulting occupational exposure or offsite dose rates from the implementation of Amendment No. 14 would remain well within the limits specified by 10 CFR part 20, “Standards for Protection Against Radiation.” 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.

The amended Holtec International HI-STORM 100 Cask System design, when used under the conditions specified in the certificate of compliance, 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 ensured. 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 those HI-STORM 100 Cask System casks that meet the criteria of Amendment No. 14 to Certificate of Compliance No. 1014.

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 will revise the Holtec International HI-STORM 100 Cask System design listed in § 72.214. This action does not constitute the establishment of a standard that contains generally applicable requirements.

Under the “Policy Statement on Adequacy and Compatibility of Agreement State Programs” approved by the Commission on June 30, 1997, and published in the Federal Register on September 3, 1997 (62 FR 46517), this rule is classified as Compatibility Category “NRC.” Compatibility is not required for Category “NRC” regulations. 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. 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 subpart A of 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 this environmental assessment.

The action is to amend § 72.214 to revise the Holtec International HI-STORM 100 Cask System listing within the “List of approved spent fuel storage casks” to include Amendment No. 14 to Certificate of Compliance No. 1014.

This direct final rule amends the certificate of compliance for the Holtec International HI-STORM 100 Cask System design within the list of approved spent fuel storage casks that power reactor licensees can use to store spent fuel at reactor sites under a general license. Specifically, Amendment No. 14 updates the certificate of compliance to: (1) Add three new regionalized Quarter Symmetric Heat Load loading patterns for the MPC-68M; (2) reduce the minimum cooling time to 1 year for all fuel types for storage in the MPC-68M; (3) use a damaged fuel isolator for damaged fuel stored in the MPC-68M; and (4) modify the description of the vents in the overpack in the certificate of compliance and remove the word “four” from Section 1.b describing the air inlet and outlet vents. Amendment No. 14 also makes other administrative changes to the technical specifications.

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 initially analyzed in the environmental assessment for the 1990 final rule. The environmental assessment for this Amendment No. 14 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.

Holtec International HI-STORM 100 Cask Systems are 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, 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.

Considering the specific design requirements for each accident condition, the design of the cask would prevent loss of confinement, shielding, and criticality control in the event of an accident. If there is no loss of confinement, shielding, or criticality control, the environmental impacts resulting from an accident would be insignificant. 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. 14 would remain well within 10 CFR part 20 limits. Therefore, the proposed certificate of compliance 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 of, radiological accidents.

The NRC documented its safety findings in a preliminary safety evaluation report.

The alternative to this action is to deny approval of Amendment No. 14 and not issue the direct final rule. Consequently, any 10 CFR part 72 general licensee that seeks to load spent nuclear fuel into the Holtec International HI-STORM 100 Cask System in accordance with the changes described in proposed Amendment No. 14 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 the same as the proposed action.

Approval of Amendment No. 14 to Certificate of Compliance No. 1014 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. Based on the foregoing environmental assessment, the NRC concludes that this direct final rule entitled “List of Approved Spent Fuel Storage Casks: Holtec International HI-STORM 100 Multipurpose Canister Cask System, Certificate of Compliance No. 1014, Amendment No. 14,” 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 Holtec International. 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 it notifies the NRC in advance, the spent fuel is stored under the conditions specified in the cask's certificate of compliance, and the conditions of the general license are met. A list of NRC-approved cask designs is contained in § 72.214. On May 1, 2000 (65 FR 25241), the NRC issued an amendment to 10 CFR part 72 that approved the HI-STORM 100 Cask System design by adding it to the list of NRC-approved cask designs in § 72.214.

On October 31, 2018, and as supplemented on November 6, 2018, February 28, 2019, April 5, 2019, April 23, 2019, May 13, 2019, and August 8, 2019, Holtec International submitted an application to amend the Holtec International HI-STORM 100 Multipurpose Canister Cask System as described in Section IV, “Discussion of Changes,” of this document.

The alternative to this action is to withhold approval of Amendment No. 14 and to require any 10 CFR part 72 general licensee seeking to load spent nuclear fuel into the Holtec International HI-STORM 100 Cask System under the changes described in Amendment No. 14 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. No other available alternative is believed to be as satisfactory, and 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. 1014 for the Holtec International HI-STORM 100 Cask System, as currently listed in § 72.214. The amendment consists of the changes in Amendment No. 14 previously described, as set forth in the revised certificate of compliance and technical specifications.

Amendment No. 14 to Certificate of Compliance No. 1014 for the Holtec International HI-STORM 100 Cask System was initiated by Holtec International and was not submitted in response to new NRC requirements, or an NRC request for amendment. Amendment No. 14 applies only to new casks fabricated and used under Amendment No. 14. These changes do not affect existing users of the Holtec International HI-STORM 100 Cask System, and previous amendments continue to be effective for existing users. While current certificate of compliance users may comply with the new requirements in Amendment No. 14, this would be a voluntary decision on the part of current users.

For these reasons, Amendment No. 14 to Certificate of Compliance No. 1014 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 staff 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 through the following methods.

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-2019-0160. The Federal Rulemaking website allows you to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) Navigate to the docket folder (NRC-2019-0160); (2) click the “Sign up for Email Alerts” link; and (3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

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:

The Federal Reserve Banks make primary and secondary credit available to depository institutions as a backup source of funding on a short-term basis, usually overnight. The primary and secondary credit rates are the interest rates that the twelve Federal Reserve Banks charge for extensions of credit under these programs. In accordance with the Federal Reserve Act, the primary and secondary credit rates are established by the boards of directors of the Federal Reserve Banks, subject to the review and determination of the Board.

On September 18, 2019, the Board voted to approve a 1/4 percentage point decrease in the primary credit rate in effect at each of the twelve Federal Reserve Banks, thereby decreasing from 2.75 percent to 2.50 percent the rate that each Reserve Bank charges for extensions of primary credit. In addition, the Board had previously approved the renewal of the secondary credit rate formula, the primary credit rate plus 50 basis points. Under the formula, the secondary credit rate in effect at each of the twelve Federal Reserve Banks decreased by 1/4 percentage point as a result of the Board's primary credit rate action, thereby decreasing from 3.25 percent to 3.00 percent the rate that each Reserve Bank charges for extensions of secondary credit. The amendments to Regulation A reflect these rate changes.

The 1/4 percentage point decrease in the primary credit rate was associated with a decrease in the target range for the federal funds rate (from a target range of 2 to 2 1/4 percent to a target range of 1 3/4 to 2 percent) announced by the Federal Open Market Committee on September 18, 2019, as described in the Board's amendment of its Regulation D published elsewhere in today's Federal Register .

In general, the Administrative Procedure Act (“APA”)  1 imposes three principal requirements when an agency promulgates legislative rules (rules made pursuant to Congressionally-delegated authority): (1) Publication with adequate notice of a proposed rule; (2) followed by a meaningful opportunity for the public to comment on the rule's content; and (3) publication of the final rule not less than 30 days before its effective date. The APA provides that notice and comment procedures do not apply if the agency for good cause finds them to be “unnecessary, impracticable, or contrary to the public interest.”  2 Section 553(d) of the APA also provides that publication at least 30 days prior to a rule's effective date is not required for (1) a substantive rule which grants or recognizes an exemption or relieves a restriction; (2) interpretive rules and statements of policy; or (3) a rule for which the agency finds good cause for shortened notice and publishes its reasoning with the rule. 3 The APA further provides that the notice, public comment, and delayed effective date requirements of 5 U.S.C. 553 do not apply “to the extent that there is involved . . . a matter relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.”  4

Regulation A establishes the interest rates that the twelve Reserve Banks charge for extensions of primary credit and secondary credit. The Board has determined that the notice, public comment, and delayed effective date requirements of the APA do not apply to these final amendments to Regulation A. The amendments involve a matter relating to loans and are therefore exempt under the terms of the APA. Furthermore, because delay would undermine the Board's action in responding to economic data and conditions, the Board has determined that “good cause” exists within the meaning of the APA to dispense with the notice, public comment, and delayed effective date procedures of the APA with respect to the final amendments to Regulation A.

The Regulatory Flexibility Act (“RFA”) does not apply to a rulemaking where a general notice of proposed rulemaking is not required. 5 As noted previously, a general notice of proposed rulemaking is not required if the final rule involves a matter relating to loans. Furthermore, the Board has determined that it is unnecessary and contrary to the public interest to publish a general notice of proposed rulemaking for this final rule. Accordingly, the RFA's requirements relating to an initial and final regulatory flexibility analysis do not apply.

In accordance with the Paperwork Reduction Act (“PRA”) of 1995, 6 the Board reviewed the final rule under the authority delegated to the Board by the Office of Management and Budget. The final rule contains no requirements subject to the PRA.

For the reasons set forth in the preamble, the Board is amending 12 CFR chapter II to read as follows:

I. Statutory and Regulatory Background

For monetary policy purposes, section 19 of the Federal Reserve Act (“the Act”) imposes reserve requirements on certain types of deposits and other liabilities of depository institutions. 1 Regulation D, which implements section 19 of the Act, requires that a depository institution meet reserve requirements by holding cash in its vault, or if vault cash is insufficient, by maintaining a balance in an account at a Federal Reserve Bank (“Reserve Bank”). 2 Section 19 also provides that balances maintained by or on behalf of certain institutions in an account at a Reserve Bank may receive earnings to be paid by the Reserve Bank at least once each quarter, at a rate or rates not to exceed the general level of short-term interest rates. 3 Institutions that are eligible to receive earnings on their balances held at Reserve Banks (“eligible institutions”) include depository institutions and certain other institutions. 4 Section 19 also provides that the Board may prescribe regulations concerning the payment of earnings on balances at a Reserve Bank. 5 Prior to these amendments, Regulation D specified a rate of 2.10 percent for both IORR and IOER. 6

The Board is amending § 204.10(b)(5) of Regulation D to specify that IORR is 1.80 percent and IOER is 1.80 percent. This 0.30 percentage point decrease in each rate was associated with a decrease in the target range for the federal funds rate, from a target range of 2 to 2 1/4 percent to a target range of 1 3/4 to 2 percent, announced by the FOMC on September 18, 2019, with an effective date of September 19, 2019. The FOMC's press release on the same day as the announcement noted that:

A Federal Reserve Implementation note released simultaneously with the announcement stated:

As a result, the Board is amending § 204.10(b)(5) of Regulation D to change IORR to 1.80 percent and IOER to 1.80 percent.

In general, the Administrative Procedure Act (“APA”)  7 imposes three principal requirements when an agency promulgates legislative rules (rules made pursuant to Congressionally-delegated authority): (1) Publication with adequate notice of a proposed rule; (2) followed by a meaningful opportunity for the public to comment on the rule's content; and (3) publication of the final rule not less than 30 days before its effective date.

The APA provides that notice and comment procedures do not apply if the agency for good cause finds them to be “unnecessary, impracticable, or contrary to the public interest.”  8 Section 553(d) of the APA also provides that publication at least 30 days prior to a rule's effective date is not required for (1) a substantive rule which grants or recognizes an exemption or relieves a restriction; (2) interpretive rules and statements of policy; or (3) a rule for which the agency finds good cause for shortened notice and publishes its reasoning with the rule. 9

The Board has determined that good cause exists for finding that the notice, public comment, and delayed effective date provisions of the APA are unnecessary, impracticable, or contrary to the public interest with respect to these final amendments to Regulation D. The rate changes for IORR and IOER that are reflected in the final amendments to Regulation D were made with a view towards accommodating commerce and business and with regard to their bearing upon the general credit situation of the country.

Notice and public comment would prevent the Board's action from being effective as promptly as necessary in the public interest and would not otherwise serve any useful purpose. Notice, public comment, and a delayed effective date would create uncertainty about the finality and effectiveness of the Board's action and undermine the effectiveness of that action.

Accordingly, the Board has determined that good cause exists to dispense with the notice, public comment, and delayed effective date procedures of the APA with respect to these final amendments to Regulation D.

The Regulatory Flexibility Act (“RFA”) does not apply to a rulemaking where a general notice of proposed rulemaking is not required. 10 As noted previously, the Board has determined that it is unnecessary and contrary to the public interest to publish a general notice of proposed rulemaking for this final rule. Accordingly, the RFA's requirements relating to an initial and final regulatory flexibility analysis do not apply.

In accordance with the Paperwork Reduction Act (“PRA”) of 1995, 11 the Board reviewed the final rule under the authority delegated to the Board by the Office of Management and Budget. The final rule contains no requirements subject to the PRA.

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

Discussion

In September 2019, the FAA received reports of cracking discovered in the left and right hand side outboard chords of the station (STA) 663.75 frame fittings and failsafe straps adjacent to the stringer S-18A straps on multiple Boeing Model 737-800 airplanes during a passenger-to-freighter conversion. The affected airplanes had accumulated between 35,578 and 37,329 total flight cycles. Cracking in the STA 663.75 frame fitting outboard chords and failsafe straps adjacent to the stringer S-18A straps, if not addressed, could result in failure of a Principal Structural Element (PSE) to sustain limit load. This condition could adversely affect the structural integrity of the airplane and result in loss of control of the airplane.

The FAA reviewed Boeing Multi-Operator Message MOM-MOM-19-0536-01B, dated September 30, 2019. This service information describes procedures for a detailed inspection for cracking of the left and right hand side outboard chords of the STA 663.75 frame fittings and failsafe straps adjacent to the stringer S-18A straps. This service information also provides procedures for reporting inspection results to Boeing. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA is issuing this AD because the agency evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This AD requires repetitive inspections for cracking of the left and right hand side outboard chords of the STA 663.75 frame fittings and failsafe straps adjacent to the stringer S-18A straps. This AD also requires repair of all cracking using a method approved by the FAA or The Boeing Company Organization Designation Authorization (ODA). This AD also requires sending a report of all results of the initial inspection to Boeing.

The FAA considers this AD interim action. The inspection reports that are required by this AD will enable the manufacturer to obtain better insight into the nature, cause, and extent of the cracking, and eventually to develop final action to address the unsafe condition. Once final action has been identified, the FAA might consider further rulemaking.

Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C.) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without seeking comment prior to the rulemaking. Similarly, Section 553(d) of the APA authorizes agencies to make rules effective in less than thirty days, upon a finding of good cause.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies forgoing notice and comment prior to adoption of this rule because cracking in the STA 663.75 frame fitting outboard chords and failsafe straps adjacent to the stringer S-18A straps could result in failure of a PSE to sustain limit load. This condition could adversely affect the structural integrity of the airplane and result in loss of control of the airplane. The compliance time for the required action is shorter than the time necessary for the public to comment and for publication of the final rule.

Accordingly, notice and opportunity for prior public comment are impracticable and contrary to the public interest pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for the reasons stated above, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, the FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2019-0711 and Product Identifier 2019-NM-167-AD at the beginning of your comments. The FAA specifically invites comments on the overall regulatory, economic, environmental, and energy aspects of this final rule. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

The FAA will post all comments the agency receives, without change, to http://www.regulations.gov, including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact the agency receives about this final rule.

The requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 1,911 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it makes the necessary updates for airspace areas within the National Airspace System.

Federal Aviation Administration Airspace Order 7400.11, Airspace Designations and Reporting Points, incorporated by reference in 14 CFR 71.1, is published yearly. Amendments referred to as “effective date straddling amendments” were published under Order 7400.11C (dated August 13, 2018, and effective September 15, 2018), but became effective under Order 7400.11D (dated August 8, 2019, and effective September 15, 2019). This action incorporates these rules into the current FAA Order 7400.11D.

Accordingly, as this is an administrative correction to update final rule amendments into FAA Order 7400.11D, notice and public procedure under 5 U.S.C. 553(b) are unnecessary. Also, to bring these rules and legal descriptions current, I find that good cause exists, under 5 U.S.C. 553(d), for making this amendment effective in less than 30 days.

This document amends FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019. FAA Order 7400.11D is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11D lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by incorporating certain final rules into the current FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019, which are depicted on aeronautical charts.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

1. For Docket No. FAA-2018-0250; Airspace Docket No. 17-AGL-3 (84 FR 8414; March 8, 2019)

a. On page 8414, column 2, line 17, and line 30, under ADDRESSES , “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

b. On page 8414, column 3, line 32, and line 34, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

c. On page 8414, column 3, line 28, under History, “. . .FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019 . . .”.

d. On page 8414, column 3, line 28, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019, . . .”.

2. For Docket No. FAA-2019-0035; Airspace Docket No. 19-ASW-2 (84 FR 20257, May 9, 2019).

a. On page 20257, column 2, line 49, and line 3, under ADDRESSES , “ . . . FAA Order 7400.11C. . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

b. On page 20257, column 3, line 61, and line 63, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

c. On page 20257, column 3, line 47, under History, “. . . FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019 . . .”.

d. On page 20257, column 3, line 57, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019, . . .”.

3. For Docket No. FAA-2019-0107; Airspace Docket No. 19-ASW-4 (84 FR 22701, May 20, 2019).

a. On page 22701, column 1, line 27, and line 10, under ADDRESSES , “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

b. On page 22701, column 2, line 42, and line 44, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

c. On page 22701, column 2, line 28, under History, “. . . FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019 . . .”.

d. On page 22701, column 2, line 38, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019, . . .”.

4. For Docket No. FAA-2018-0985; Airspace Docket No. 18-AWP-19 (84 FR 34051, July 17, 2019).

a. On page 34051, column 1, line 45, and column 2, line 3, under ADDRESSES , “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

b. On page 34051, column 3, line 8, and line 10, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

c. On page 34051, column 2, line 53, under History, “. . . FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019 . . .”.

d. On page 34051, column 3, line 4, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019, . . .”.

5. For Docket No. FAA-2018-1026; Airspace Docket No. 18-AEA-20 (84 FR 34054, July 17, 2019).

a. On page 34054, column 3, line 40, and line 53, under ADDRESSES , “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D. . .”.

b. On page 34055, column 1, line 58, and line 60, under Availability and Summary of Documents for Incorporation by Reference “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

c. On page 34055, column 1, line 44, under History, “. . . FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019 . . .”.

d. On page 34055, column 1, line 54, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019, . . . ”.

6. For Docket No. FAA-2018-0816; Airspace Docket No. 18-AWP-7 (84 FR 34055, July 17, 2019).

a. On page 34056, column 1, line 16, under ADDRESSES , “. . . FAA Order 7400.11C. . .” is corrected to read “. . . FAA Order 7400.11D. . .”.

b. On page 34056, column 2, line 29, and line 31, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D. . .”.

c. On page 34056, column 2, line 15, under History, “. . . FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019 . . .”.

d. On page 34056, column 2, line 25, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019, . ”.

7. For Docket No. FAA-2019-0347; Airspace Docket No. 19-AEA-6 (84 FR 35290, July 23, 2019).

a. On page 35291, column 1, line 4, and line 17, under ADDRESSES , “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

b. On page 35291, column 2, line 38, and line 40, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

c. On page 35291, column 2, line 24, under History, “. . . FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019. . .”.

d. On page 35291, column 2, line 34, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019, . . .”.

8. For Docket No. FAA-2018-0713; Airspace Docket No. 18-AWP-10 (84 FR 35292, July 23, 2019).

a. On page 35292, column 2, line 11, and line 24, under ADDRESSES , “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

b. On page 35292, column 3, line 15, and line 17, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C. . .” is corrected to read “ . . . FAA Order 7400.11D. . .”.

c. On page 35293, column 1, line 26, under The Rule, “. . . FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019 . . .”.

d. On page 35292, column 3, line 11, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018,. . .” is corrected to read “. . . FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019, . . .”.

9. For Docket No. FAA-2019-0060; Airspace Docket No. 18-ASO-20 (84 FR 35538, July 24, 2019).

a. On page 35538, column 2, line 28, and line 41, under ADDRESSES , “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

b. On page 35538, column 3, line 41, and line 43, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

c. On page 35538, column 3, line 27, under History, “. . . FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019 . . .”.

d. On page 35538, column 3, line 37, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019, . . .”.

10. For Docket No. FAA-2019-0222; Airspace Docket No. 19-ASW-5 (84 FR 35819, July 25, 2019).

a. On page 35819, column 1, line 30, and line 43, under ADDRESSES , “. . . FAA Order 7400.11C. . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

b. On page 35819, column 2, line 41, and line 43, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

c. On page 39587, column 2, line 37, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

11. For Docket No. FAA-2019-0273; Airspace Docket No. 19-AGL-10 (84 FR 36466, July 29, 2019).

a. On page 36466, column 2, line 17, and line 30, under ADDRESSES , “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

b. On page 36466, column 3, line 29, and line 32, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

c. On page 36466, column 3, line 16, under History, “. . . FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019. . .”.

d. On page 36466, column 3, line 26, under Availability and Summary of Documents for Incorporation by Reference “. . . FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019, . . ”.

12. For Docket No. FAA-2018-1022; Airspace Docket No. 18-ANE-8 (84 FR 36467, July 29, 2019).

a. On page 36467, column 1, line 9, under ADDRESSES , “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

b. On page 36467, column 3, line 45, and line 47, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

c. On page 36467, column 3, line 31, under History, “. . . FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019. . .”.

d. On page 36467, column 3, line 41, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019, . . .”.

13. For Docket No. FAA-2019-0310; Airspace Docket No. 19-ACE-7 (84 FR 37961, August 5, 2019).

a. On page 37961, column 2, line 33, and line 46, under ADDRESSES , “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

b. On page 37961, column 3, line 51, and line 53, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C . . .” is corrected to read “. . . FAA Order 7400.11D . . .”.

c. On page 37961, column 3, line 37, under History, “. . . FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, . . .” is corrected to read “. . . FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019 . . .”.

d. On page 37961, column 3, line 47, under Availability and Summary of Documents for Incorporation by Reference, “. . . FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018,. . .” is corrected to read “. . . FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019, . . .”.

I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port San Francisco DHS Department of Homeland Security § Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary final 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 with respect to this rule because it is impracticable.

On September 21, 2019, the Coast Guard was informed of forecasted extreme environmental conditions occurring near three respective locations of California likely to exceed the maximum environmental limits of the 47-foot Motor Lifeboat employed by the Coast Guard as the primary rescue asset in each area. These three locations are: The Humboldt Bay Bar and Entrance Channel, near Eureka, CA; the Noyo River Entrance Channel, near Fort Bragg, CA; and the Crescent City Harbor Entrance Channel, near Crescent City, CA. The National Oceanic and Atmospheric Administration's National Weather Service forecasts up to 19-foot breaking seas in the area from 25 September, 2019 through 26 September, 2019. This area is subject to extreme weather annually, but this year's forecast of extreme weather starting in September is earlier than is typical. Last year's comparable forecast of 24-foot breaking seas occurred in November, which is typically the month when the Coast Guard has historically established temporary safety zones in the navigable waters of the Humboldt Bay Bar and Entrance Channel, of Eureka, CA, Noyo River Entrance Channel, of Fort Bragg, CA, and Crescent City Harbor Entrance Channel, of Crescent City, CA. Due to the consistency of extreme environmental conditions typically observed between the months of November and March each winter, the Coast Guard is in the process of establishing a permanent regulation to account for intermittent periods of hazardous conditions, such as high wind or breaking surf. That regulation is expected to begin the notice and comment phase of public rulemaking shortly. Between now and the implementation of the permanent regulation, if enacted, these three safety zones are necessary to provide for the safety of mariners transiting the area due to the dangers posed by these extreme environmental conditions and the resulting limited availability of rescue assets. The Coast Guard learned of the extreme weather forecast on 21 September 2019, and must establish the three safety zones before 25 September 2019, and so lacks sufficient time to provide a reasonable comment period and to consider comments before issuing the rule.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause also exists for making this rule effective less than 30 days after publication in the Federal Register . For similar reasons as stated above, notice and comment procedures would be impracticable in this instance because the hazardous conditions associated with the extreme environmental conditions precipitating the rulemaking will occur before the full rulemaking process could be completed.

The Coast Guard is issuing this rule under authority 46 U.S.C. 70034 (previously 33 U.S.C. 1231). Notable hazards associated with the extreme environmental conditions have been observed in the Humboldt Bay Bar and Entrance Channel near Eureka, CA; the Noyo River Entrance Channel, near Fort Bragg, CA; and the Crescent City Harbor Entrance Channel, of Crescent City, CA. These safety zones establish temporary restricted areas on the navigable waters of the Humboldt Bay Bar and Entrance Channel near Eureka, CA; the Noyo River Entrance Channel, near Fort Bragg, CA; and the Crescent City Harbor Entrance Channel, of Crescent City, CA. Because extreme environmental conditions are predicted for September 25, 2019 which is outside of the typical season between November and March when dangerous sea state conditions have historically been observed, these restricted areas are necessary to mitigate the risks associated with vessels transiting the area while extreme environmental conditions exist on scene.

The Coast Guard will enforce, independent of each other, three respective safety zones in the navigable waters of the Humboldt Bay Bar and Entrance Channel near Eureka, CA; the Noyo River Entrance Channel, near Fort Bragg, CA; and the Crescent City Harbor Entrance Channel, of Crescent City, CA, when the COTP determines that the on scene conditions are hazardous and unsafe for vessel transits, typically expected to be 20-foot breaking seas at each location. Enforcement will be announced via Broadcast Notice to Mariners. These safety zones are effective from September 25, 2019, through December 31, 2019. These safety zones will be enforced with actual notice until this rulemaking is published in the Federal Register , and with constructive notice thereafter.

The effect of the temporary safety zones is to restrict navigation in the vicinity of the Humboldt Bay Bar and Entrance Channel; Noyo River Entrance Channel; and Crescent City Harbor Entrance Channel while the hazardous conditions associated with extreme environmental conditions exist, and until the Coast Guard deems the safety zone is no longer needed. Except for persons or vessels authorized by the COTP or the COTP's designated representative, no person or vessel may enter or remain in the restricted areas during times of enforcement. As used in the rule, “designated representative” means a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer on a Coast Guard vessel or at a Coast Guard unit or a Federal, State, or local officer designated by or assisting the COTP in the enforcement of the safety zones. These three regulated areas are needed to keep vessels away from the immediate vicinity of the hazardous conditions associated with the forecasted extreme weather to ensure the safety of transiting vessels in each respective area.

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. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. 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), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the limited duration and narrowly tailored geographic area of the safety zones. Although this rule restricts access to the waters encompassed by the safety zones, the effect of this rule will not be significant because the local waterway users will be notified via public Broadcast Notice to Mariners to ensure the safety zones will result in minimum impact, and because the rule will be enforced only during dangerous conditions caused by extreme weather. The entities most likely to be affected are waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities.

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.

This rule may affect the following entities, some of which may be small entities: Owners and operators of waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities and sightseeing, if these facilities or vessels are in the vicinity of the safety zones at times when the zones are being enforced. This rule will not have a significant economic impact on a substantial number of small entities for the following reasons: (i) This rule will encompass only a small portion of the waterway for a limited period of time while hazardous conditions exist, and (ii) the maritime public will be advised in advance of this safety zones via Broadcast Notice to Mariners.

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

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

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

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

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

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such 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 and U.S. Coast Guard Environmental Planning Policy, 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 three safety zones which will be implemented during periods of extreme environmental conditions in Humboldt Bay Bar and Entrance Channel near Eureka, CA; the Noyo River Entrance Channel, near Fort Bragg, CA; and the Crescent City Harbor Entrance Channel, of Crescent City, CA. It is categorically excluded from further review under paragraph L60(a) in Table 3-1 of Department of Homeland Security Directive 023-01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES .

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

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

Throughout this document, “we,” “us” and “our” refer to the EPA.

On April 25, 2019, the EPA proposed to determine that the West Central Pinal County nonattainment area attained the 2006 24-hour PM 2.5 NAAQS by December 31, 2017, the statutory attainment date for the area. 1 Our proposed action is based on the three-year average of annual 98th percentile 24-hour concentrations for the 2015-2017 period, using complete, quality-assured, and certified PM 2.5 monitoring data.

For an area classified as Moderate under the Clean Air Act (CAA), such as the West Central Pinal County PM 2.5 nonattainment area, section 188(c) provides that the statutory attainment date is “as expeditiously as practicable but no later than the end of the sixth calendar year after the area's designation as nonattainment.” Therefore, the applicable attainment date for West Central Pinal County, designated nonattainment in 2011 and classified as Moderate in 2014, is attainment as expeditiously as practicable, but no later than December 31, 2017. 2 Section 188(b)(2) of the CAA requires that the Administrator determine whether the state has attained the NAAQS in a nonattainment area by the applicable attainment date. Consequently, the EPA's proposed determination of attainment is pursuant to the Agency's statutory obligation, under CAA section 188(b)(2), to determine whether the West Central Pinal County nonattainment area has attained the 2006 24-hour PM 2.5 NAAQS by no later than December 31, 2017. Given this attainment date and the form of the 2006 24-hour PM 2.5 NAAQS, the applicable 3-year data review period is calendar years 2015 to 2017.

Under 40 CFR part 50, § 50.13 and in accordance with appendix N, a nonattainment area meets the 2006 24-hour PM 2.5 NAAQS when the area's design value is less than or equal to 35 micrograms per cubic meter (µg/m 3 ). As discussed in detail in Section III of our proposal, the determination of whether an area's air quality meets the 2006 24-hour PM 2.5 NAAQS is generally based upon three years of complete, quality-assured data gathered at established state and local air monitoring stations (SLAMS) in a nonattainment area and entered into the EPA's Air Quality System (AQS) database. 3 Because we are determining attainment of the PM 2.5 NAAQS as of December 31, 2017, the applicable 3-year data review period is 2015-2017. Ambient air quality data must generally meet data completeness or substitution requirements for each year under evaluation. The data completeness requirements are met when at least 75 percent of the scheduled sampling days for each quarter have valid data. 4 The state must submit data from ambient air monitors operated by state or local agencies in compliance with the EPA monitoring requirements to AQS. Monitoring agencies certify annually that these data are accurate to the best of their knowledge. Accordingly, the EPA relies primarily on data in AQS when determining the attainment status of areas.

The PM 2.5 ambient air quality monitoring data collected within the West Central Pinal County nonattainment area for the 2015-2017 period must meet data completeness or substitution criteria according to 40 CFR part 50, appendix N. The ambient air quality monitoring data completeness requirements are met when quarterly data capture rates for all four quarters in a calendar year are at least 75 percent. 5 For the purposes of our proposal, we reviewed the data for the 2015-2017 period for completeness and determined that the PM 2.5 data collected by Pinal County met the completeness criterion for all 12 quarters at PM 2.5 monitoring sites in the West Central Pinal County nonattainment area. The 2015 Cowtown data were complete, and the 2016 and 2017 Hidden Valley data, the relocated Cowtown monitoring site, were complete. 6

The EPA's proposed determination as to whether the West Central Pinal County area has attained the PM 2.5 NAAQS pursuant to CAA section 188(b)(2) was based on monitored ambient air quality data. The validity of this determination depends in part on whether the monitoring network adequately measures ambient PM 2.5 levels in the nonattainment area. Pinal County, the local agency responsible for collecting PM 2.5 data in the nonattainment area, submits annual monitoring network plans to the EPA. These plans describe the status of the air monitoring network, including monitor siting, as required under 40 CFR part 58. The EPA reviews these annual network plans for compliance with the applicable monitoring requirements in 40 CFR 58.10. With respect to PM 2.5 , we have found that the annual network plans submitted by Pinal County meet the applicable requirements under 40 CFR part 58. 7 Furthermore, we concluded in our “Technical Systems Audit Report” of Pinal County's ambient air quality monitoring program that the ambient air monitoring network currently meets or exceeds the requirements for the minimum number of monitoring sites designated as SLAMS for PM 2.5 in the West Central Pinal County nonattainment area. 8 Pinal County certifies annually that the data it submits to AQS are quality-assured and has done so for each year relevant to this determination of attainment, 2015-2017. 9

Our proposal also discussed the EPA's review and approval of Pinal County's January 2016 relocation of the PM 2.5 SLAMS monitoring site from the Cowtown location to a new location at Hidden Valley. 10 Beginning in late 2013 and through 2015, Pinal County and the EPA engaged in a cooperative multi-year process to review alternative locations and relocate the Cowtown PM 2.5 SLAMS monitoring site. Over the course of 2014 and 2015, Pinal County operated temporary monitors at two other potential replacement monitoring site locations ( i.e., Hidden Valley; and White and Parker). This allowed Pinal County and the EPA to assess the data from each location and to determine if either of the proposed monitoring site locations met the applicable system modification requirements in 40 CFR 58.14 for monitoring site relocation. Based on an assessment of PM 2.5 concentrations, land use, and nearby sources, the EPA approved the relocation of the Cowtown PM 2.5 SLAMS monitoring site to the new Hidden Valley location. 11 The EPA stated in its Relocation Approval Letter that the data from the old and new monitoring site locations would be combined to form one continuous data record for design value calculations. 12 Consequently, the 2015-2017 design value is a composite data record consisting of 2015 data from the Cowtown monitoring site and 2016 and 2017 data from the relocated Cowtown site, now operating at Hidden Valley.

In summary, the EPA's evaluation of whether the West Central Pinal County nonattainment area has met the 2006 PM 2.5 24-hour NAAQS is based on our review of the monitoring data, the adequacy of the PM 2.5 monitoring network in the nonattainment area, and the reliability of the data collected by the network, as discussed in detail in our proposal for this action. The data indicate that the 24-hour design value for the 2015-2017 period, 32 µg/m 3 , was less than or equal to 35 µg/m 3 , the 2006 PM 2.5 24-hour NAAQS. Therefore, the EPA proposed to determine, based upon three years of complete, quality-assured and certified data from 2015-2017, that the West Central Pinal County nonattainment area attained the 2006 24-hour PM 2.5 NAAQS by the applicable outermost attainment date, December 31, 2017.

The public comment period on the proposed rule opened on April 25, 2019, the date of its publication in the Federal Register , and closed on May 28, 2019. During this period, the EPA received one comment letter submitted by the Center for Biological Diversity (CBD). The CBD's comments are addressed below. A copy of their comment letter is included in the docket for this final action.

Comment #1: The EPA did not follow Federal regulations and erred in determining attainment of the 24-hour PM 2.5 NAAQS over the 2015-2017 timeframe for two reasons. First, three years of annual data is needed at “each eligible monitoring site” to determine a design value. The Cowtown and Hidden Valley monitors constitute separate monitoring sites, and the EPA did not have three years of annual data at either site. Second, for a combined site data record, the monitoring sites must be collocated. 13 Cowtown and Hidden Valley, however, are not collocated monitoring sites as defined by Federal regulations. Therefore, the EPA's calculated 2015-2017 design value was calculated incorrectly and is inconsistent with Federal regulations for developing design values from two separate monitoring sites.

Response #1: The EPA disagrees with the commenter's contention that combining the data from the two sites is not permitted under the Act and applicable Federal regulations. The EPA's monitoring regulations addressing “[s]ystem modification” contain a specific provision that allows for relocating an air quality monitoring site: “[a] SLAMS monitor not eligible for removal under any of the criteria in paragraphs (c)(1) through (c)(5) of this section may be moved to a nearby location with the same scale of representation if logistical problems beyond the State's control make it impossible to continue operation at its current site.”  14 By referring to “mov[ing]” a monitor, as opposed to “remov[ing]” it, 15 the monitoring regulations allow for such monitors to be treated as a single site for design value calculation purposes.

As discussed in our proposal, in 2013 logistical problems beyond the State's control made it impossible for Pinal County to continue operation of the Cowtown monitor. From late 2013 through 2015, Pinal County and the EPA engaged in a cooperative multi-year process to review and evaluate alternative locations and to relocate the Cowtown PM 2.5 SLAMS monitoring site, ultimately to the Hidden Valley monitoring site. Because Pinal County moved the Cowtown monitor in accordance with the appropriate EPA regulations and guidance, including a notice and opportunity for public comment, and the EPA approved the site relocation, it is appropriate to combine the data from before and after the relocation for the purpose of calculating valid design values. We review this monitor relocation effort in more detail below.

In 2013, the private landowners of the Cowtown monitoring site notified Pinal County that they would no longer allow the County's long-term use of their property for the monitoring site. In response, Pinal County negotiated a two-year lease extension to allow for continued data collection at the site while the County and the EPA worked to relocate the monitor appropriately according to Federal regulations and EPA guidance. Generally, the EPA interprets “nearby location with same scale of representation” to mean a nearby location that measures similar pollutant concentrations from similar emissions sources. In 2014, Pinal County initiated a special study to evaluate locations throughout the West Central Pinal County PM 2.5 nonattainment area that would meet the EPA's monitor siting and relocation requirements, i.e., nearby locations with the same scale of representation.

Viable long-term monitoring locations in the immediate vicinity of the Cowtown monitor were not available. As a result, from June 2014 to June 2015, Pinal County conducted parallel ambient monitoring at two nearby locations with a similar source mix and proximity to sources as the Cowtown monitor: Hidden Valley; and White and Parker. The monitoring at the three different sites revealed that with respect to the 98th percentile PM 2.5 value, the key value for 24-hour NAAQS design value calculations, the Cowtown monitors and the Hidden Valley monitor tracked closely (28.5 and 29.0 µg/m 3 for the two Cowtown monitors, compared to 30.6 µg/m 3 for the Hidden Valley monitor). The other candidate location, White and Parker, did not track as closely (with a value of 24.9 µg/m 3 ), even though it was closer to the Cowtown monitors. 16 The concurrent monitoring over a year at multiple monitoring sites demonstrates that the County was able to find another very similar site less than ten miles from the original site, thus satisfying the regulatory requirements for an air quality monitor relocation.

To conclude our review of this multi-year relocation effort, at Pinal County's request, the EPA evaluated the collected data and approved the relocation of the Cowtown monitoring site to the current Hidden Valley monitoring site location. The EPA determined that Pinal County met all applicable requirements of 40 CFR 58.14(c)(6) and specifically stated in our October 22, 2015 approval letter that “[a]s this is a relocation, the data from the old and new sites will be combined to form one continuous data record for design value calculations.”  17 The EPA notes that Pinal County's analysis and the EPA's approval letter were subject to public comment as part of Pinal County's 2017 annual network plan submission and that the County received no adverse comments. 18 Because the transition from the Cowtown monitor to the Hidden Valley monitor constituted a relocation and was subject to the EPA's approval under 40 CFR 58.14(c)(6), it was appropriate for the EPA to use the old and new monitoring sites in calculating a design value for the West Central Pinal County nonattainment area. 19

The combination of data from two monitoring sites to calculate a valid design value following an approved relocation has been a longstanding and common EPA practice. The EPA's 2017 Design Value Report for PM 2.5 shows 18 PM 2.5 monitoring sites nationwide for which pre- and post-relocation monitors are linked for design value calculation purposes. 20 The design value reports for other pollutants show even more linked monitors. 21

The EPA's longstanding practice of combining data from two monitoring sites when calculating a design value was explained in the recent 2015 Ozone (O 3 ) NAAQS revision. In that rulemaking, the EPA specifically codified the existing convention in 40 CFR part 50, appendix U, and explained that “although data handling appendices for previous O 3 standards do not explicitly mention site combinations, the EPA has approved over 100 site combinations since the promulgation of the first 8-hour O 3 NAAQS in 1997”. 22 The EPA explained, “the EPA's intention in proposing this addition was merely to codify an existing convention, and to improve transparency by implementing site combinations in AQS design value calculations.”  23 The final rulemaking also noted that “[p]ublic commenters unanimously supported” the change in regulatory text and further clarified that “[s]ince this provision has already been used in practice under previous O 3 standards, site combinations will be applied to AQS design value calculations for both the revised O 3 standards and previous O 3 standards.”  24 The EPA's preamble in the proposed rule for the 2015 Ozone NAAQS revision further expands on the EPA's rationale concerning site combinations and states that “[s]ite combinations may be approved by the Regional Administrator, after he or she has determined that the measured air quality concentrations do not differ substantially between the two sites.”  25 Although this specific rulemaking was for the 2015 ozone NAAQS, the EPA has used the same longstanding convention for PM 2.5 site combinations, as described above. As with the ozone NAAQS design value calculations in advance of the 2015 ozone NAAQS final rule, the fact that the EPA has not at this point expressly codified this practice in regulatory provisions for PM 2.5 does not prevent the EPA from combining PM 2.5 data for relocated monitors in line with its longstanding practice and as allowed under 40 CFR 58.14(c)(6).

To summarize our response to the commenter's first point challenging our use of data from relocated monitors, in order to locate a site that constituted a “nearby location with the same scale of representation” under § 58.14(c)(6), Pinal County and the EPA engaged in a cooperative multi-year process to review alternative locations and relocate the Cowtown PM 2.5 SLAMS monitoring site due to logistical problems beyond the control of the State or the District. Pinal County and the EPA analyzed the data from candidate locations to determine if the proposed monitoring site locations met the applicable system modification requirements in 40 CFR 58.14 for monitoring site relocation. Specifically, based on an assessment of PM 2.5 concentrations (which concurrent ambient monitoring demonstrated to track closely), land use, and nearby sources, the EPA approved the relocation of the Cowtown PM 2.5 SLAMS monitoring site to the new Hidden Valley location. As noted in the EPA's Relocation Approval Letter, the data from the Cowtown and Hidden Valley monitoring site locations are suitable for combination to form one continuous data record for design value calculations. This approach is both authorized by the EPA's monitoring regulations, and consistent with the EPA's longstanding practice. Consequently, the 2015-2017 design value the EPA used for this determination of attainment is consistent with Federal regulations concerning monitor relocations and the EPA's past policy and precedent for combining monitoring site data when computing a design value in such circumstances.

The commenter's second argument, that “[f]or a combined site data record, monitors have to be [collocated],” is inapposite. The definition of “combined site data record,” given in 40 CFR part 50, appendix N, section 1.0(c) is “the data set used for performing calculations in appendix N. It represents data for the primary monitors augmented with data from collocated monitors . . . .” Although this provision makes clear that data from collocated monitors may be used to augment data from primary monitors, it does not prohibit the combination of data from a primary monitor, before and after it is relocated. Accordingly, the EPA does not agree that the regulation defining “combined site data record” indicates that the proposed determination of attainment was inappropriate.

Comment #2: The CBD writes that the 98th percentile value for the 2016-2018 period is above the NAAQS. The CBD suggests that this indicates three things: First, compared to the 2016-2018 Hidden Valley monitor's annual concentration, the 2015 Cowtown monitor's annual concentration is so low as to suggest that it is not representative of the Cowtown monitoring site;  26 second, the area has a PM 2.5 pollution problem, as evidenced by the fact that it is violating the NAAQS based on 2018 data; and third, over 2016-2018, the Hidden Valley monitoring site concentration values are trending upward.

Response #2: In this notice, the EPA is acting pursuant to its statutory obligation to “[w]ithin 6 months following the applicable attainment date for a PM 10 [or PM 2.5 ] nonattainment area . . . determine whether the area attained the standard by that date.”  27 As explained above, and in our proposal, the attainment date for the West Central Pinal County PM 2.5 nonattainment area is December 31, 2017. 28 The statutory requirement to determine whether the area has attained “by that date” sets the timeframe for the EPA's analysis. The Act requires the EPA to determine whether the West Central Pinal County PM 2.5 nonattainment area attained the standard by December 31, 2017. Accordingly, to the extent that CBD's comment suggests that the EPA must evaluate monitoring data that was collected subsequent to the applicable attainment date, the EPA disagrees. The EPA will continue to review data for 2018 and subsequent years, but these data are outside the scope of the present action.

The CBD's comment regarding whether the Cowtown site is “representative” is unclear. To the extent that CBD's comment argues that the 2018 data from Hidden Valley site indicates that the 2015 data from the Cowtown site is not representative of the Cowtown site and ambient air quality at that site, this statement is unsubstantiated. The fact that the 2015 Cowtown design value is lower than the 2016, 2017, and 2018 measurements at Hidden Valley does not mean that the 2015 Cowtown data is not representative of the Cowtown site and ambient air quality at that location, as measured in 2015. The State and the EPA evaluated the respective monitor locations in 2015 and 2018 as part of the annual monitoring network review process, and both were consistent with applicable regulatory siting requirements. 29 Some annual variation in monitor data is not particularly unusual for a 24-hour NAAQS and does not automatically call into question the validity of a monitor location. Absent some indication of a technical problem with the Cowtown monitor, which the commenter does not suggest, the 2015 data collected at the Cowtown site is representative of the ambient PM 2.5 concentrations at the Cowtown site in 2015.

To the extent that CBD's comment argues that the 2018 data and CBD's calculated 2016-2018 design value indicate that the Cowtown site is not representative of the Hidden Valley site, or vice versa, in our response to Comment #1, we discussed our rationale for approving the relocation of the Cowtown monitoring site and determining a design value using data from both the Cowtown and Hidden Valley monitors. The EPA concluded through that process, involving more than two years of cooperation with the District and substantial concurrent monitoring at the Cowtown and Hidden Valley sites, followed by a public notice and comment period, that the Hidden Valley site was a “nearby location with the same scale of representation” as the Cowtown site. 30 That analysis demonstrated, based on almost a year of concurrent sampling, from June 2014 to June 2015, that the 98th percentile PM 2.5 concentration between the two sites tracked closely. 31 Moreover, the EPA's relocation analysis included an investigation of the land use, and nearby sources surrounding the two sites, and concluded that they were similar. 32 In light of the substantial concurrent monitoring data and additional analysis completed by the EPA, the commenter's suggestion that a cross-year comparison of data streams from different locations shows that one monitoring site is either not representative of the other, or not representative of ambient PM 2.5 concentrations at the time they were observed, is not persuasive. In general, pollution levels can exhibit annual variation, with particulate matter pollution in arid regions showing a strong dependency on variable factors such as variations in levels of local and/or regional anthropogenic emissions, the effectiveness of existing local measures, and meteorology. Considering these varying factors, a simple cross-year comparison of the monitoring data at each location does not establish the comparability of the two sites and is not a useful means of determining that the different monitor locations are validly measuring ambient PM 2.5 concentrations accurately. Accordingly, the EPA disagrees with the commenter that the 2018 monitoring data, and any design value calculations stemming from it, indicate that the 2015 Cowtown data are not representative of ambient PM 2.5 concentrations in 2015, or that the Cowtown and Hidden Valley sites are not sufficiently representative of each other, and the ambient PM 2.5 concentrations at these sites.

The CBD's remaining comments, that the 2018 data shows that the West Central Pinal County nonattainment area has a pollution problem and that it shows an upward trend over time, address issues that are outside the scope of the present action. As explained above, the statutory timeframe for the EPA's analysis in this determination of attainment ends at the applicable attainment date of December 31, 2017. Although the EPA may consider the more recent air quality monitoring data after this date in future actions, it does not bear on the EPA's statutory obligation under 42 U.S.C. 7513(b)(2) to determine whether the West Central Pinal County nonattainment area has attained the standard “by that date.”   33 Accordingly, the EPA disagrees with the commenter that the EPA should determine that the West Central Pinal County nonattainment area did not attain the 2006 24-hour PM 2.5 NAAQS by its December 31, 2017 attainment date because of monitoring data from 2018.

For the reasons discussed in our proposed action and in this final rule, under section 188(b)(2) of the CAA, the EPA is taking final action to determine that the West Central Pinal County Moderate nonattainment area attained the 2006 24-hour PM 2.5 NAAQS by its applicable attainment date, December 31, 2017. Our determination of attainment is based on complete, quality-assured and certified PM 2.5 monitoring data for the appropriate three-year period, 2015-2017.

Once effective, this action satisfies the EPA's obligation pursuant to CAA section 188(b)(2) to determine whether this area attained the standards by the applicable attainment date. This determination of attainment does not constitute a redesignation to attainment. Rather, redesignations require states to meet several statutory criteria in CAA section 107(d)(3), including EPA approval of a state plan demonstrating maintenance of the air quality standards for 10 years after redesignation.

This final action determines that West Central Pinal County has met the 2006 24-hour PM 2.5 NAAQS as a statement of fact according to regulations and requirements discussed in this action and in the prior proposal. For that reason, this action:

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

• Is not expected to be an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because this action is not significant under Executive Order 12866;

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

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

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

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

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

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

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

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

This action does not have tribal implications as specified in Executive Order 13175. No tribal areas are located within the West Central Pinal County PM 2.5 nonattainment area. The CAA and the Tribal Authority Rule establish the relationship of the Federal Government and tribes in developing plans to attain the NAAQS, and this rule does nothing to modify that relationship. Thus, Executive Order 13175 (65 FR 67249, November 9, 2000) does not apply to this action.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 2, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review, does not extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

For the reasons stated in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2018-0243 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 December 2, 2019. 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-2018-0243, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets .

In the Federal Register of October 18, 2018 (83 FR 52787) (FRL-9984-21), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP IN-11139) by Monsanto, 1300 I Street NW, Washington, DC 20005. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of furilazole when used as an inert ingredient (safener) in pesticide formulations applied to corn, sweet, forage at 0.01 parts per million (ppm); corn, sweet, kernel plus cob with husks removed at 0.01 ppm; and corn, sweet, stover at 0.01 ppm. That document referenced a summary of the petition prepared by Monsanto, the registrant, which is available in the docket, http://www.regulations.gov .

Based upon review of the data supporting the petition, EPA is establishing the tolerances as requested.

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

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

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The toxicological profile of furilazole is discussed in the final tolerance rule found in the Federal Register of October 10, 2007 (72 FR 57489) (FRL-8145-2). Specific information on the studies received and the nature of the adverse effects caused by furilazole as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in Unit III.A. of that Federal Register document and in the supporting documents for that rule. In addition, due to the similarities between that rule and this, EPA is incorporating the findings concerning the children's safety factor and cumulative exposure into this rule because they also apply to this rulemaking. The summary of toxicological endpoints the Agency used to assess risk are discussed in the final tolerance rule found in the Federal Register of April 3, 2002 (67 FR 15727) (FRL-6828-4).

1. Dietary exposure (food and drinking water). In evaluating dietary exposure to furilazole, EPA considered exposure under the proposed exemption from the requirement of a tolerance as well as the already established tolerances for furilazole.

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

No such effects were identified in the toxicological studies for the general population for furilazole; therefore, a quantitative acute dietary exposure assessment for the general population is unnecessary.

However, such effects were identified for furilazole for females 13 to 50 years old. In estimating acute dietary exposure, EPA used 2003-2008 food consumption information from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA conducted an unrefined acute dietary exposure and risk assessment assuming 100 percent crop treated (PCT), default processing factors, and tolerance-level residues for all food commodities.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used 2003-2008 food consumption data from the USDA's NHANES/WWEIA. As to residue levels in food, EPA conducted an unrefined chronic dietary exposure and risk assessment assuming 100 PCT, default processing factors (when available), and tolerance level residues for all food commodities.

iii. Cancer. As indicated in the 2002 Federal Register document, EPA has concluded that furilazole should be classified as a possible human carcinogen and a linear approach has been used the quantify cancer risk since no mode of action data are available. The aggregate cancer risk assessment for adults takes into account exposure estimates from dietary consumption of furilazole from food and drinking water sources. Dietary exposure assessments were quantified using the same estimates as discussed in Unit III.B.1.ii, Chronic Exposure.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for furilazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of furilazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide .

The estimated drinking water concentrations (EDWCs) of furilazole for acute exposures are estimated to be 1.2 parts per billion (ppb) for surface water and 0.02 ppb for ground water; for chronic exposures for non-cancer assessments are estimated to be 0.8 ppb for surface water and 0.02 ppb for ground water; and for chronic exposures for cancer assessments are estimated to be 0.22 ppb for surface water and 0.02 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the acute dietary risk assessment, a water concentration value of 1.2 ppb was used to assess the contribution to drinking water, for the chronic dietary risk assessment, the water concentration value of 0.8 ppb was used to assess the contribution to drinking water. For the cancer dietary risk assessment, the water concentration value of 0.22 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables). There are no residential uses of furilazole; therefore, a residential exposure assessment was not conducted.

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

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to furilazole and any other substances; furilazole does not appear to produce any other toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that furilazole has a common mechanism of toxicity with other substances.

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to furilazole will be less than 1% for females 13 to 49 years old, the only population group of concern.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to furilazole from food and water will utilize 13.3% of the cPAD for non-nursing infants, the population group receiving the greatest exposure. There are no expected residential uses and therefore chronic residential exposure to residues of furilazole is not expected.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there are no proposed or registered residential uses of furilazole a short-term assessment was not performed. The chronic risk assessment is protective for any short-term exposures from food and drinking water.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there are no proposed or registered residential uses of furilazole an intermediate-term assessment was not performed. The chronic risk assessment is protective for any intermediate-term exposures from food and drinking water. Furilazole is not currently registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that intermediate-term aggregate exposure assessment is not necessary.

5. Aggregate cancer risk for U.S. population. A cancer aggregate assessment was conducted for furilazole since it is classified as a “Group C, Possible Human Carcinogen” with a Q 1 * of 0.0274 (mg/kg/day) −1 based upon hepatocellular ademonas and carcinomas in rats and mice, branchioalveolar adenomas and carcinomas in female mice, testicular interstitial cell interstitial cell tumors in male rats, and stomach tumors in female mice. The cancer risk estimate for adults is 1.1 × 10 −6 .

EPA generally considers cancer risks (expressed as the probability of an increased cancer case) in the range of 1 in 1 million (or 1 × 10 −6 ) or less to be negligible. The precision which can be assumed for cancer risk estimates is best described by rounding to the nearest integral order of magnitude on the logarithmic scale; for example, risks falling between 3 × 10 −7 and 3 × 10 −6 are expressed as risks in the range of 10 −6 . Considering the precision with which cancer hazard can be estimated, the conservativeness of low-dose linear extrapolation, and the rounding procedure described above, cancer risk should generally not be assumed to exceed the benchmark level of concern of the range of 10 −6 until the calculated risk exceeds approximately 3 × 10 −6 . This is particularly the case where some conservatism is maintained in the exposure assessment. EPA has concluded the cancer risk for all existing furilazole uses and the uses associated with the tolerances established in this action fall within the range of 1 × 10 −6 and are thus negligible.

EPA has concluded that using the nonlinear approach based on the chronic RfD will be protective of potential carcinogenicity.

Because the chronic risk is below the Agency's level of concern, EPA concludes there is no aggregate cancer risk from exposure to furilazole.

6. Determination of safety. Taking into consideration all available information on furilazole, EPA has determined that there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure to furilazole.

Adequate enforcement methodology (capillary gas chromotography using electron capture detection) is available to enforce the tolerance exemption expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov .

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established any MRLs for furilazole.

Three comments were submitted to the docket for this action. One dealt with “relaxing” current EPA standards; another argued that inert ingredients should be regulated through tolerances. A third comment took issue with data submitted about the toxicity of “Florazole” (which EPA assumes is a typographical error and is meant to apply to furilazole).

This action establishes tolerances for an inert ingredient used as a safener in pesticide products; it is not relaxing EPA standards or ignoring the potential adverse effects of inert ingredients. Inert ingredients are evaluated under the same safety standard as active ingredients under the FFDCA. Under the existing legal framework provided by FFDCA section 408, EPA is authorized to establish pesticide chemical tolerances or exemptions where persons seeking such tolerances or exemptions have demonstrated that the pesticide chemical meets the safety standard imposed by the statute. EPA has evaluated the potential adverse effects from exposure to this pesticide chemical, taking into consideration data on the potential for developmental toxicity and carcinogenicity. No new toxicity data were submitted in connection with the present petition. After evaluating the available data and other information, EPA has determined that the tolerances for this chemical are safe. The commenters have provided no other information for the Agency to consider in making its safety determination.

Based on available data, the Agency concludes that tolerances for residues of furilazole as discussed in this document are safe. Accordingly, the Agency is establishing tolerances for residues of furilazole in or on corn, sweet, forage; corn, sweet, kernel plus cob with husks removed; and corn, sweet, stover at 0.01 ppm. In addition, EPA is revising the tolerance expression to clarify that (1) as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of furilazole not specifically mentioned and (2) compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression. EPA has determined that it is reasonable to make this change final without prior proposal and opportunity for comment, because public comment is not necessary, in that the change has no substantive effect on the tolerance, but rather is merely intended to clarify the existing tolerance expression.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq. ). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

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

Therefore, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0046 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 December 2, 2019. 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-2017-0046, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of June 8, 2017 (82 FR 26641) (FRL-9961-14), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (IN-11012) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268. The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of nicotinamide (CAS Reg. No. 98-92-0) when used as an inert ingredient (corrosion inhibitor) in pesticide formulations applied to growing crops, limited to 5% in the pesticide formulation. That document referenced a summary of the petition prepared by Dow AgroSciences LLC, the petitioner, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit V.B.

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

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

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

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

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

Nicotinamide is a water-soluble B-complex vitamin which is present naturally in animal products, whole cereals and legumes. Together with nicotinic acid (niacin), nicotinamide belongs to vitamin B3 and is required as a nutrient to prevent niacin deficiency disorders such as pellagra. It functions as a coenzyme or co-substrate in many biological reduction and oxidation reactions required for energy metabolism in mammalian systems. It is used as a nutritional supplement, therapeutic agent, skin and hair conditioning agent in cosmetics and a constituent of consumer, household solvent and cleaning products.

As a nutritional supplement and vitamin, recommended daily dietary allowances and maximum daily doses have been established by the Institute of Medicine (US) Standing Committee on the Scientific Evaluation of Dietary Reference Intakes and its Panel on Folate, Other B Vitamins, and Choline. The committee also established the tolerance upper intake level at 35 mg/day based on flushing as a critical adverse effect. The level applies to all forms of niacin added to foods or taken as supplements, including nicotinamide. Although nicotinamide is not associated with flushing effects, a UL for nicotinic acid based on flushing is protective against the other effects seen in the available toxicity studies.

Nicotinamide exhibits low levels of acute toxicity. The rat acute oral lethal dose (LD 50 ) is 3,000-7,000 milligrams/kilogram (mg/kg). The acute dermal LD 50 for rabbits is > 2,000 mg/kg. Nicotinamide is negative for skin sensitization in the guinea pig. It is not irritating to rabbit skin. Nicotinamide is considered irritating to rabbit eyes.

In a 4-week oral toxicity via gavage, no adverse effects were observed in female rats at dose levels below treated with 1,000 mg/kg/day of nicotinamide.

In a developmental toxicity study involving exposure to nicotinic acid, no effects in the dams (decreased body weight gains and significantly decreased placental weights) and fetuses (significantly lower body weights in male offspring) were observed at dose levels below 1,000 mg/kg/day. The NOAEL for maternal and developmental toxicity is 200 mg/kg/day (198 mg/kg/day for nicotinamide). This study is deemed relevant to the assessment of nicotinamide since nicotinamide converts to nicotinic acid in the gut.

Nicotinamide was negative in Ames tests, micronucleus tests, with and without metabolic activation. No chromosomal effects were reported in mammalian cells. Positive results were seen in a sister chromatid exchange induction study. However, it was noted that activity was only seen at excessively high concentrations. Based on the weight of evidence, nicotinamide is considered negative for mutagenicity.

Nicotinamide is not carcinogenic. No increased incidence of tumors was observed in a lifetime carcinogenicity study with Swiss mice receiving 1.0% (equivalent to 66.3 and 100 mg/kg/day in female and male rats, respectively) nicotinamide in the diet.

There were no data directly regarding the potential for neurotoxicity or immunotoxicity of nicotinamide. However, there is no evidence of potential neurotoxicity or immunotoxicity in the available data.

Metabolism of nicotinamide in humans is well understood. Nicotinamide is necessary for lipid metabolism, tissue respiration and glycogenolysis. It is readily absorbed in the gastrointestinal (g.i.) tract. In vivo, nicotinamide is formed from the conversion of nicotinic acid (niacin), while some dietary nicotinamide is oxidized to nicotinic acid and then to nicotinamide. Nicotinamide is incorporated into two coenzymes: Nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP) which act as hydrogen-carrier molecules in glycogenolysis, tissue respiration and lipid metabolism. It can be incorporated into NADP either directly or after deamidation, or metabolized in the liver and excreted in the urine. The primary metabolites are N-methylniacinamide and N-methyl-2-pyridone-5- carboxamide, though it may also be excreted unchanged.

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

The available toxicity studies indicate that nicotinamide has a very low overall toxicity. No effects are observed below 1,000 mg/kg/day, the limit dose. Since signs of toxicity were not observed below the limit dose an endpoint of concern for risk assessment purposes was not identified.

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

Nicotinamide is already approved for use (synergist) on growing crops. The current request (for use as a corrosion inhibitor) increases dietary exposure (food and drinking water) to nicotinamide that can occur following ingestion of foods with residues from treated crops. In addition, dietary exposure to nicotinamide may also occur through foods that contain it naturally, such as grains, meat and milk; fortified foods, and dietary supplements. However, a quantitative dietary exposure assessment was not conducted since a toxicological endpoint for risk assessment was not identified.

2. Dietary exposure from drinking water. Since a hazard endpoint of concern was not identified for the acute and chronic dietary assessment, a quantitative dietary exposure risk assessment for drinking water was not conducted, although exposures may be expected from use on food crops.

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

Nicotinamide may be used as an inert ingredient in pesticide products that are registered for specific uses that may result in residential exposure, such as pesticides used in and around the home, and in non-pesticide products such as household products, personal care products and cosmetics. However, based on the lack of a hazard endpoint of concern, a quantitative residential exposure assessment for nicotinamide was not conducted.

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

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

Based on the lack of threshold effects, EPA has not identified any toxicological endpoints of concern and is conducting a qualitative assessment of nicotinamide. The qualitative assessment does not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children. Based on an assessment of nicotinamide, EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children.

Because no toxicological endpoints of concern were identified, EPA concludes that aggregate exposure to residues of nicotinamide will not pose a risk to the U.S. population, including infants and children, and that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to nicotinamide residues.

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

Two comments were received concerning the safety and impact of pesticides on food and human health. Although the Agency recognizes that some individuals believe that no residue of pesticides should be allowed in or on food, the existing legal framework provided by section 408 of the FFDCA authorizes the establishment of pesticide tolerances or exemptions where the Agency determines that tolerance or exemption meets the safety standard imposed by the statute. EPA has sufficient data to support a safety determination for the exemption from the requirement of a tolerance for nicotinamide. The commenters have provided no additional information supporting a determination that the exemption is not safe.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.920 for nicotinamide (CAS Reg. No. 98-92-0) when used as an inert ingredient (corrosion inhibitor) in pesticide formulations applied to growing crops, limited to 5.0% in a pesticide formulation.

This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001); Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2019-0138 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 December 2, 2019. 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-2019-0138, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html . Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets .

In the Federal Register of May 13, 2019 (84 FR 20843) (FRL-9991-91), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11248) by Exponent, on behalf of LNouvel, Inc., 4657 Courtyard Trail, Plano, TX 75024-2114. The petition requested that 40 CFR 180.930 be amended by establishing an exemption from the requirement of a tolerance for residues of poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy)disiloxanyl)propyl)-ω-hydroxy- (CAS Reg. No. 67674-67-3) when used as an inert ingredient in pesticide formulations applied to animals. That document referenced a summary of the petition prepared by Exponent, on behalf of LNouvel, Inc., the petitioner, which is available in the docket, http://www.regulations.gov . There were no comments received in response to the notice of filing.

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

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

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

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

Poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy exhibits low levels of acute toxicity. Acute studies in rats showed oral LD 50 of >1,600 mg/kg. The dermal LD 50 in rats was >3,200 mg/kg. No acute inhalation studies were available. Poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- is considered to be an eye irritant and a mild skin irritant. However, it was not found to be a dermal sensitizer.

Repeat dose studies on poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- are limited. In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in rats, effects seen at 1,000 mg/kg/day, the highest dose tested ( i.e., 800 mg/kg/day to poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy-) included decreased body weight, body weight gain, and food consumption and reduced body temperature in males. No developmental/reproductive adverse effect attributed to the test substance were observed in the study.

There is no evidence that exposure to poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- suppresses or otherwise harms immune function in humans. No signs of neurotoxicity were reported in acute or repeat-dose oral studies. There were also no signs of carcinogenicity in the database. Similarly, all tests were negative for genotoxicity and mutagenicity. The available data suggests that poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- is not carcinogenic.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment.

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

A summary of the toxicological endpoints for poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- used for human risk assessment are described in this unit. The Point of Departure (POD) for all durations of oral, dermal, and inhalation exposure is based on the NOAEL of 300 mg/kg/day and the LOAEL of 1,000 mg/kg/day based on decreased body weight, body weight gain, and food consumption and reduced body temperature in males from the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test. Once corrected for the percent inert ingredient in the test formulation, the NOAEL was 240 mg/kg/day and the LOAEL was 800 mg/kg/day poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy-.

A 100-fold uncertainty factor was used (10X interspecies extrapolation, 10X for intraspecies variability, and 1X FQPA safety factor (SF)). The FQPA SF is reduced to 1X because the reproductive and developmental toxicity database is complete and there is no evidence of increased risk to infants and children.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy-, EPA considered exposure under the proposed exemption from the requirement of a tolerance as well as the existing tolerance exemption for this chemical. Poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- is currently approved as a food use inert ingredient under 40 CFR 180.910. EPA assessed dietary exposures from poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- in food as follows:

Because no acute endpoint of concern was identified, a quantitative acute dietary exposure assessment is unnecessary. In conducting the chronic dietary exposure assessment using the Dietary Exposure Evaluation Model DEEM-FCID TM , Version 3.16, EPA used food consumption information from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What we eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. The Inert Dietary Exposure Evaluation Model (I-DEEM) is a highly conservative model with the assumption that the residue level of the inert ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this assumption is that there would be similar rates of degradation between the active and inert ingredient (if any) and that the concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient. The model assumes 100 percent crop treated (PCT) for all crops and that every food eaten by a person each day has tolerance-level residues. This model incorporates all current and proposed pesticidal food uses for this inert ingredient.

2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy-, a conservative drinking water concentration value of 100 ppb based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables). A review of residential products containing this inert ingredient revealed that it is currently used in fungicides, herbicides, and insecticides applied to residential settings, mainly on lawns and turf. In an effort to assess exposure, the EPA has conducted a conservative screening-level assessment using high-end exposure scenarios for pesticidal use on lawns/turf. For each residential scenario, short-term exposure for both the handler (adult) and post-application exposure (adult and child) is expected. Based on the use pattern ( e.g., pre- and post-harvest uses, use on lawns), intermediate-term and long-term pesticidal exposures from residential uses are not expected.

In addition to the proposed and current pesticidal uses of poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy-, poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- is also used in various non-pesticidal products; however, quantifiable exposure data are not available for these exposure scenarios.

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

EPA has not found poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- to share a common mechanism of toxicity with any other substances, and poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative .

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

2. Prenatal and postnatal sensitivity. A combined repeated dose toxicity study with a reproduction/developmental toxicity screening test showed no effect on reproductive parameters of fertility in the absence of maternal toxicity.

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

i. The toxicity database for poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- is complete.

ii. There is no indication that poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- results in increased susceptibility in in utero rats in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in rats.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy-.

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

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- from food and water will utilize 29.4% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- is currently used as an inert ingredient in pesticide products that are registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy-.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 390 for adults and 175 for children 1 to 2 years old. Because EPA's level of concern for poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- is a MOE of 100 or below, these MOEs are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). A potential intermediate-term adverse effect was identified; however, poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- is not currently used as an inert ingredient in pesticide products that are registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy-.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity, poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- is not expected to pose a cancer risk to humans.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy-residues.

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

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.930 for poly(oxy-1,2-ethanediyl), α-(3-(1,3,3,3-tetramethyl-1-((trimethylsilyl) oxy) disiloxanyl) propyl)-ω-hydroxy- (CAS Reg. No. 67674-67-3) when used as an inert ingredient (surfactant) in pesticide formulations applied to animals.

This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), nor is it considered a regulatory action for purposes of Executive Order 13771, entitled “reducing Regulations and Controlling Regulatory Costs (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq. ). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

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

Therefore, 40 CFR chapter I is amended as follows:

States that have received final approval from the EPA under RCRA Section 9004(b) of RCRA, 42 U.S.C. 6991c(b), must maintain an underground storage tank program that is equivalent to, consistent with, and no less stringent than the Federal UST program. Either EPA or the approved state may initiate program revision. When EPA makes revisions to the regulations that govern the UST program, states must revise their programs to comply with the updated regulations and submit these revisions to the EPA for approval. Program revision may be necessary when the controlling Federal or state statutory or regulatory authority is modified or when responsibility for the state program is shifted to a new agency or agencies.

On October 12, 2018, in accordance with 40 CFR 281.51(a), Maine submitted a complete program revision application seeking the EPA approval for its UST program revisions (State Application). Maine's revisions correspond to the EPA final rule published on July 15, 2015 (80 FR 41566), which revised the 1988 UST regulations and the 1988 state program approval (SPA) regulations (2015 Federal Revisions). As required by 40 CFR 281.20, the State Application contains the following: A transmittal letter requesting approval, a description of the program and operating procedures, a demonstration of the State's procedures to ensure adequate enforcement, a Memorandum of Agreement outlining the roles and responsibilities of the EPA and the implementing agency, a statement of certification from the Attorney General, and copies of all relevant state statutes and regulations. We have reviewed the State Application and determined that the revisions to Maine's UST program are equivalent to, consistent with, and no less stringent than the corresponding Federal requirements in subpart C of 40 CFR part 281, and that the Maine program provides for adequate enforcement of compliance (40 CFR 281.11(b)).

The statement of certification from the Attorney General asserts that the State “possesses authority over UST activities on Indian lands in the State” pursuant to the Act to Implement the Maine Indian Claims Settlement (“Maine Implementing Act” or “MIA”), 30 M.R.S. Sections 6201 to 6214, and the Federal Maine Indian Claims Settlement Act (“MICSA”), 1980 Public Law 96-420 (Oct. 10, 1980).

Under basic principles of Federal Indian law, states generally lack civil regulatory jurisdiction within Indian country as defined in 18 U.S.C. Section 202F;1151. Alaska v. Native Village Of Venetie Tribal Government, 522 U.S. 520, 527 n.1 (1998). Thus, EPA cannot presume a state has authority to regulate in Indian country, including with regard to UST activities. Instead, a state must demonstrate its jurisdiction, and EPA must determine that the state has made the requisite demonstration and expressly determine that the state has authority, before a state can implement a program in Indian country.

Based on the unique jurisdictional framework established in MIA, MICSA, and the two companion laws for the Aroostook Band of Micmacs  1 and Houlton Band of Maliseet Indians, 2 EPA has previously determined that the State of Maine has civil regulatory jurisdiction in Indian country in two contexts. In 2012, EPA determined that the State has jurisdiction to issue National Pollution Discharge Elimination System (“NPDES”) permits under the Clean Water Act in the territories of the Penobscot Indian Nation and Passamaquoddy Tribe. 77 FR 23481, 23482 (April 19, 2012); see also Maine v. Johnson, 498 F.3d 37 (1st Cir. 2007); 78 FR 13339, 13349 (“EPA proposes to approve the state to implement its NPDES program in the territories of the Houlton Band of Maliseet Indians and the Aroostook Band of Micmacs. . . .”). In 2015, EPA determined that the State has authority to set water quality standards under the Clean Water for waters in Tribal lands. February 2, 2015, Letter from H. Curtis Spalding, EPA Regional Administrator, to Patricia W. Aho, Maine Department of Environmental Protection Commissioner, Re: Review and Decision on Water Quality Standards Revisions, available at https://www.epa.gov/sites/production/files/2016-04/documents/me_let_020215.pdf .

In recognition of the significant time and resources needed to address the State's assertion of authority to regulate UST activities on Tribal lands, the EPA is not making a determination on such authority as part of this decision. This approach allows EPA to move forward with approval of the State's program elsewhere in the State while it continues to work on the State's assertion in Tribal lands. EPA is committed to acting on the State's assertion of authority. It will do so following the necessary consultation with the federally recognized Indian tribes in Maine, consistent with Executive Order 13175 (Nov. 6, 2000) and EPA's Policy on Consultation and Coordination with Indian Tribes (May 4, 2011).

Therefore, the EPA grants Maine final approval to operate its UST program with the changes described in the State Application, and as outlined below in Section I.G of this document, except as is relates to USTs on Indian lands.

This action does not impose additional requirements on the regulated community because the regulations being approved by this rule are already effective in Maine, and they are not changed by this action. This action merely approves the existing State regulations as meeting the Federal requirements and renders them federally enforceable.

EPA is publishing this direct final rule concurrent with a proposed rule because we view this as a noncontroversial action and anticipate no adverse comment. EPA is providing an opportunity for public comment now.

Along with this direct final, the EPA is publishing a separate document in the “Proposed Rules” Section of this issue of the Federal Register that serves as the proposal to approve the State's UST program revisions, providing opportunity for public comment. If EPA receives comments that oppose this approval, EPA will withdraw the direct final rule by publishing a document in the Federal Register before the rule becomes effective. The EPA will base any further decision on the approval of the State program changes after considering all comments received during the comment period. EPA will then address all public comments in a later final rule. You may not have another opportunity to comment. If you want to comment on this approval, you must do so at this time.

On June 11, 1992, the EPA finalized a rule approving the UST program, effective July 13, 1992, to operate in lieu of the Federal program. On February 21, 1996, effective April 22, 1996, the EPA codified the approved Maine program, incorporating by reference the State statutes and regulatory provisions that are subject to EPA's inspection and enforcement authorities under RCRA Sections 9005 and 9006, 42 U.S.C. 6991d and 6991e, and other applicable statutory and regulatory provisions.

On October 12, 2018, in accordance with 40 CFR 281.51(a), Maine submitted a complete application for final approval of its UST program revisions adopted on September 26, 2018. The EPA now makes an immediate final decision, subject to receipt of written comments that oppose this action, that Maine's UST program revisions satisfy all of the requirements necessary to qualify for final approval. Therefore, EPA grants Maine final approval, except as it relates to USTs on Indian lands, for the following program changes:

The State also demonstrates that its program provides adequate enforcement of compliance as described in 40 CFR 281.11(b) and part 281, subpart D. The ME DEP has broad statutory authority with respect to USTs to regulate installation, operation, maintenance, closure, and UST releases, and to the issuance of orders. These statutory authorities are found in: Maine Revised Statutes Annotated, Title 4: Judiciary, Title 5: Administrative Procedures and Services, Title 14: Court Procedure—Civil, Title 17: Crimes, Title 38: Waters and Navigation.

The following statutory and regulatory provisions are considered broader in scope than the Federal program, and are therefore not enforceable as a matter of Federal law:

A facility owner or operator may use the Maine Ground and Surface Waters Cleanup and Response Fund in accordance with the eligibility requirements and financial assurance limits of the Oil Discharge Prevention and Pollution Control Law, 38 M.R.S. Section 551 and the Oil Storage Facilities Groundwater Protection Law, 568-A, in combination with one or more of the other mechanisms to assure full coverage of third party damage liability in accordance with the minimum financial assurance requirements of Chapter 691, Rule for Underground Oil Storage Facilities, Sections 5(D)(15)(a) and (b) in meeting the State's and EPA's financial responsibility requirements for underground storage tanks containing petroleum.

The owner of a facility is responsible for ensuring that the entire facility is inspected annually for compliance. The facility owner shall submit annual inspection results to the Commissioner on each July 1st, unless the Department agrees to an alternate schedule for submittal that is no less frequent than once every 12 months. The inspection results must be recorded on a form provided by the Commissioner and must include a certification statement, signed by a Certified Underground Oil Storage Tank Installer or Inspector. The statement must certify that the entire facility was inspected and any deficiencies discovered have been corrected.

A tank and its associated piping must be taken out of operation and properly abandoned upon the expiration date of the tank warranty. When the length of the tank warranty is either unknown or the tank was installed after January 1, 2008, the tank will be deemed to have a tank warranty of 30 years from the date of installation. An extension may be granted if the tank, its associated piping and other facility components pass integrity testing. Single walled waste oil tanks and their associated piping are required to be taken out of operation and properly abandoned by October 13, 2019. A deed notation is required for all tanks and piping abandoned in place. All abandoned facilities and tanks used for the storage of Class I liquids that require removal must be removed under the direct, on-site supervision of a certified underground storage tanks installer.

New or replacement tanks and piping at heating oil or process oil storage facilities used for consumption on the premises or by the owner or operator are required to be constructed of fiberglass, cathodically protected steel, or other noncorrosive material approved by the Commissioner. All tanks and piping must be secondarily contained with continuous interstitial space monitoring. Tanks with a capacity over 1,100 gallons must have spill and overfill prevention equipment.

Only a properly certified Underground Oil Storage Tank Installer with the appropriate class of certification and that has paid the required certification fee may install an underground oil storage facility. The Certified Installer shall be present and supervise all aspects of the underground storage tank facility installation, including the excavation and replacement of a concrete pad, backfill, or soil within ten feet of an underground oil storage tank or facility product piping. Within 30 days of installation completion, the Certified Installer is responsible for providing the Commissioner with a certification that the facility, materials, design, and installation are in compliance with all State requirements.

Tanks are prohibited from installation within one foot of bedrock. In sensitive geologic areas with known contamination, bedrock blasting during installation may not occur without the Department's approval.

For all new installations and replacements of tanks and piping the facility owner shall maintain a to-scale, as-built drawing of the facility at the facility or the owner's primary place of business. The drawing is to show the location of tanks, piping, dispensers and other major underground facility components to facilitate safe facility maintenance, repairs, replacement, and remediation. No permanent structures, underground utilities or other objects may be installed or constructed near a tank such that it would impede the tank's safe removal.

If a tank is replaced, all associated underground piping not meeting the design requirements of Chapter 691 shall be replaced. Underground piping meeting the requirements of Chapter 691 must be precision tested in accordance with Appendix B prior to continued use. If product piping is replaced and structural damage to the associated tank has occurred, impairing its physical integrity, the tank must also be replaced or repaired. Tanks that cannot be repaired must be abandoned in accordance with Chapter 691, Section 11.

Repairs of a galvanic cathodic protection system must be completed by a Maine Certified Underground Oil Storage Tank Installer (Certified Installer) within 180 days of a failed test. If anodes are added to a tank, the Certified Installer shall submit written documentation that all repairs were conducted in accordance with recommended practices of STI or NACE. Testing and recalibration of overfill and spill prevention alarms and shutoff systems must be conducted by a Certified Installer or Maine Certified Underground Oil Storage Tank Inspector (Certified Inspector) who is also certified by the manufacturer of the equipment if available. Repairs of automatic overfill and spill prevention alarm and shutoff systems must be done by a Certified Installer or for certain minor repairs a Certified Inspector within 30 days. Repairs, other than corrosion induced or product incompatibility caused leaks, to fiberglass, cathodically protected steel and other approved noncorrosive material tanks and piping must be properly conducted by a Certified Installer. The Certified Installer must also be certified by the tank or piping manufacturer, when available, to conduct a repair without a manufacturer representative, so as not to void the manufacturer warranty.

New and replacement underground waste oil facilities may not be located beneath a building or other permanent structure or within 25 feet of a classified body of surface water.

At least 60 days prior to new and replacement field constructed underground oil storage tank registration, design and installation plans must be submitted to the Commissioner for review and approval. The tank must be designed by a professional engineer in compliance with Maine's professional regulation statute, and constructed in accordance with UL Standard 1746, “Corrosion Protection Systems for Underground Storage Tanks”, and API Standard 650 “Welded Steel Tanks or Oil Storage”. All phases of assembly and installation must be supervised by the professional engineer. Within 30 days of installation completion, the engineer shall submit a certification to the Commissioner stating that the facility materials, design, and installation meet all applicable State requirements. If a tank is replaced, all associated piping not meeting the design and installation requirements of Chapter 691, Rule for Underground Oil Storage Facilities, Section 8. (Chapter 691, Section 8.) must be replaced except if the piping is part of an airport hydrant piping system. Piping connected to field constructed tanks must be designed and constructed in accordance with the requirements of Chapter 691, Rule for Underground Oil Storage Facilities, Sections 5., 6., 7., 9., or 10. depending on the type of facility and piping system proposed. If product piping attached to a field constructed tank is replaced and structural damage to the associated tank occurred impairing its physical integrity, the tank must also be replaced if not designed and installed in accordance with Chapter 691, Section 8.

New or replacement tanks at facilities storing heavy oils; oil that must be heated during storage, including but not limited to #5 and #6 oil; and #4 oil only when it must be heated during storage, must be installed in accordance with National Fire Protection Association Code 31 and the requirements of Chapter 691, Section 6(B)(4), (5), and (6), except that the installation of copper and PVC piping is prohibited and the heating system must be electrically isolated from the cathodic protection system if the tank is steel. All facility construction materials must be compatible with the temperature at which the product is to be stored. Fiberglass or plastic jacketed component may not be installed in facilities where the oil temperature will exceed 150 °F. Only a properly certified Class 2 underground storage tank installer may install an underground heavy oil storage facility. New and replacement fiberglass and plastic jacketed steel tanks must have continuous product temperature monitoring equipment which much be tested, and if necessary, calibrated at least annually. If a tank is replaced, all associated underground piping not meeting the design requirements of Chapter 691 must be replaced. Any replacement piping must be designed and installed in accordance with Chapter 691. If product piping is replaced and structural damage to the tank has occurred, the associated tank must also be replaced if not constructed of fiberglass, cathodically protected steel, or other noncorrosive material approved by the Commissioner. Repairs of damaged fiberglass, cathodically protected steel, and other Commissioner approved tanks may only be made if conducted in accordance with Chapter 691, Sections 5(D)(13) or (14). Tanks that cannot be repaired must be abandoned in accordance with Chapter 691, Section 11.

At least 60 days prior to new or replacement airport hydrant piping registration, installation plans must be submitted for Department review and approval. New and replacement airport hydrant piping must be designed by a professional engineer and constructed in accordance with American National Standards Institute (ANSI) standard for “Chemical Plant and Petroleum Refinery Piping”, ANSI/ASME B 31.1. New and replacement airport hydrant piping must be installed according to good engineering practices using radiograph inspected welded joints and under the supervision of a professional engineer licensed in Maine or otherwise working in compliance with 32 M.R.S. Sections 1351-1362. Within 30 days of installation completion the professional engineer is required to submit to the Commissioner a certification that the materials, design, and installation meet the applicable Chapter 691 Rules for Underground Oil Storage Facilities requirements. Repairs of new, replacement and existing piping must in accordance with good engineering practice and under the surveillance of a Maine professional engineer. The repaired section must be tested for leaks and for proper operation of the cathodic protection system. A report describing the repairs made and test results must be submitted to the Commissioner for approval.

The following statutory and regulatory provisions are considered more stringent than the Federal program and are therefore enforceable as a matter of Federal law:

Tank registrations require additional information from the Federal notification requirements, such as depth to bedrock and water table (when known), proximity to sensitive areas, site drawing, manufacturer warranty date.

New and replacement spill buckets must be double walled.

If more than 25% of a piping run is replaced, the entire piping run must be replaced with piping that meets the current new piping standards.

Methods of leak detection for tanks and piping that are not allowed include: For tanks, manual tank gauging, groundwater monitoring and vapor monitoring and for piping, line tightness testing.

Walkthrough inspections are conducted weekly.

Sump testing and the correction of any deficiencies must be certified by a Maine Certified Underground Oil Storage Tank Installer or Inspector.

All new and replacement field constructed tanks must have secondary containment, continuous interstitial space monitoring, and overfill and spill prevention equipment. New or replacement field constructed tank piping must have secondary containment regardless of the size of the field constructed tank.

New and replacement airport hydrant piping must have secondary containment and continuous interstitial space monitoring.

Wastewater treatment tank systems and aboveground oil storage tanks associated with field constructed tanks and airport hydrant systems are required to be registered and meet financial assurance for corrective action and third-party insurance for discharges.

Codification is the process of placing a state's statutes and regulations that comprise the state's approved UST program into the CFR. Section 9004(b) of RCRA, as amended, allows the EPA to approve State UST programs to operate in lieu of the Federal program. The EPA codifies its authorization of state programs in 40 CFR part 282 and incorporates by reference state statutes and regulations that the EPA will enforce under Sections 9005 and 9006 of RCRA and any other applicable state provisions. The incorporation by reference of state authorized programs in the CFR should substantially enhance the public's ability to discern the current status of the approved state program and state requirements that can be federally enforced. This effort provides clear notice to the public of the scope of the approved program in each state.

EPA incorporated by reference the Maine DEP approved UST program effective April 22, 1996 (61 FR 6555; February 21, 1996). In this document, EPA is revising 40 CFR 282.69 to include the approved revisions.

Incorporation by reference: In this rule, we are finalizing regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, we are finalizing the incorporation by reference of the Maine statutes and regulations described in the amendments to 40 CFR part 282 set forth below. The EPA has made, and will continue to make, these documents generally available through www.regulations.gov and at the EPA Region 1 office (see the ADDRESSES Section of this preamble for more information).

The purpose of this Federal Register document is to codify Maine's approved UST program. The codification reflects the State program that would be in effect at the time EPA's approved revisions to the Maine UST program addressed in this direct final rule become final. The document incorporates by reference Maine's UST statutes and regulations and clarifies which of these provisions are included in the approved and federally enforceable program. By codifying the approved Maine program and by amending the CFR, the public will more easily be able to discern the status of the federally-approved requirements of the Maine program.

EPA is incorporating by reference the Maine approved UST program in 40 CFR 282.69. Section 282.69(d)(1)(i)(A) incorporates by reference for enforcement purposes the State's statutes and regulations, except as it relates to USTs on Indian lands.

Section 282.69 also references the Attorney General's Statement, Demonstration of Adequate Enforcement Procedures, the Program Description, and the Memorandum of Agreement, which are approved as part of the UST program under Subtitle I of RCRA. These documents are not incorporated by reference.

The EPA retains the authority under sections 9005 and 9006 of Subtitle I of RCRA, 42 U.S.C. 6991d and 6991e, and other applicable statutory and regulatory provisions to undertake inspections and enforcement actions and to issue orders in approved states. With respect to these actions, EPA will rely on Federal sanctions, Federal inspection authorities, and Federal procedures rather than the state authorized analogues to these provisions. Therefore, the EPA is not incorporating by reference such particular, approved Maine procedural and enforcement authorities. Section 282.69(d)(1)(ii) of 40 CFR lists those approved Maine authorities that would fall into this category.

The public also needs to be aware that some provisions of the State's UST program are not part of the federally approved State program. Such provisions are not part of the RCRA Subtitle I program because they are “broader in scope” than Subtitle I of RCRA. Title 40 CFR 281.12(a)(3)(ii) states that where an approved state program has provisions that are broader in scope than the Federal program, those provisions are not a part of the federally approved program. As a result, State provisions which are broader in scope than the Federal program are not incorporated by reference for purposes of enforcement in part 282. Section 282.69(d)(1)(iii) lists for reference and clarity the Maine statutory and regulatory provisions which are broader in scope than the Federal program and which are not, therefore, part of the approved program being codified in this document. Provisions that are broader in scope cannot be enforced by EPA; the State, however, will continue to implement and enforce such provisions under State law.

This action only applies to Maine's UST Program requirements pursuant to RCRA section 9004 and imposes no requirements other than those imposed by State law. It complies with applicable Executive Orders (E.O.s) and statutory provisions as follows:

The Office of Management and Budget (OMB) has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). This action approves and codifies State requirements for the purpose of RCRA section 9004 and imposes no additional requirements beyond those imposed by State law. Therefore, this action is not subject to review by OMB.

This action is not an Executive Order 13771 (82 FR 9339, February 3, 2017) regulatory action because actions such as this final approval of Maine's revised underground storage tank program under RCRA are exempted under Executive Order 12866. Accordingly, I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ).

Because this action approves and codifies pre-existing requirements under State law and does not impose any additional enforceable duty beyond that required by State law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538). As discussed above, EPA is not acting on approval to operate the State's UST program as it applies to Tribal lands in the State. Therefore, this action also does not significantly or uniquely affect the communities of Tribal governments, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

This action 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely approves and codifies State requirements as part of the State RCRA underground storage tank program without altering the relationship or the distribution of power and responsibilities established by RCRA.

This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant, and it does not make decisions based on environmental health or safety risks.

This rule is not subject to Executive Order 13211, “Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a “significant regulatory action” as defined under Executive Order 12866.

Under RCRA section 9004(b), EPA grants a State's application for approval as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for EPA, when it reviews a State approval application, to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.

As required by Section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct.

EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order.

This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). “Burden” is defined at 5 CFR 1320.3(b).

Executive Order 12898 (59 FR 7629, February 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. Because this rule approves pre-existing State rules which are at least equivalent to, and no less stringent than existing Federal requirements, and imposes no additional requirements beyond those imposed by State law, and there are no anticipated significant adverse human health or environmental effects, the rule is not subject to Executive Order 12898.

The Congressional Review Act, 5 U.S.C. 801-808, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this document and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). However, this action will be effective December 2, 2019 because it is a direct final rule.

For the reasons set forth in the preamble, EPA is amending 40 CFR part 282 as follows:

The purpose of this action is to remove the Monito gecko from the Federal List of Endangered and Threatened Wildlife in title 50 of the Code of Federal Regulations (50 CFR 17.11(h)) ( i.e., “delisting” it) based on its recovery.

We may delist a species if the best scientific and commercial data indicate the species is neither a threatened species nor an endangered species for one or more of the following reasons: (1) The species is extinct; (2) the species has recovered; or (3) the original data used at the time the species was classified were in error (50 CFR 424.11). Here, we have determined that the species may be delisted based on recovery as follows:

• Rat predation, the threat suspected to be the main cause of an apparent population decline for the Monito gecko (factor C), was eliminated by August 1999 when the last rat eradication campaign was completed by the Puerto Rico Department of Natural and Environmental Resources (PRDNER). From August 1999 to May 2016, no rats or other potential exotic predators have been detected on Monito Island.

• The species' apparent small population size (factor E), noted as a threat at the time of listing, may have been an artifact of bias as surveys were conducted under conditions when the species was not easily detectable. The Monito gecko is currently considered abundant and widely distributed on Monito Island.

• The Monito gecko and its habitat have been and will continue to be protected under Commonwealth laws and regulations (factor D). These existing regulatory mechanisms are adequate to protect the Monito gecko now and in the future.

Despite potential climate change effects from a gradual warming trend for Puerto Rico, we expect the population to persist into the foreseeable future, especially with the current absence of other potential threats ( e.g., habitat loss, disease, predation).

On October 15, 1982, we published a final rule in the Federal Register (47 FR 46090) listing the Monito gecko as an endangered species and designating the entire island of Monito as critical habitat. On March 27, 1986, we published the Monito Gecko Recovery Plan (USFWS 1986, 18 pp.). The 5-year review, which was completed on August 8, 2016 (USFWS 2016, 25 pp.), recommended delisting the species due to recovery. On January 10, 2018 (83 FR 1223), we published a proposed rule to delist the Monito gecko.

For additional details on previous Federal actions, see discussion under the Recovery section below. Also see http://www.fws.gov/endangered/species/us-species.html for the species profile for this reptile.

In the proposed delisting rule and draft post-delisting monitoring (PDM) plan published on January 10, 2018 (83 FR 1223), we requested that all interested parties submit written comments on the proposal and plan by March 12, 2018. We also contacted appropriate Federal and State agencies, scientific experts and organizations, and other interested parties and invited them to comment on the proposal. A newspaper notice inviting general public comments was published in Primera Hora (major local newspaper) and also announced using online and social media sources. We did not receive any requests for a public hearing.

In accordance with our policy published in the Federal Register on July 1, 1994 (59 FR 34270), and the Office of Management and Budget's Final Information Quality Bulletin for Peer Review, dated December 16, 2004, we solicited the expert opinions from five appropriate and independent specialists regarding the science in the proposed rule and the draft PDM plan. The purpose of such review is to ensure that we base our decisions on scientifically sound data, assumptions, and analyses. We sent peer reviewers copies of the proposed rule and the draft PDM plan immediately following publication of the proposed rule in the Federal Register . We invited peer reviewers to comment, during the public comment period, on the specific assumptions and conclusions regarding the proposed delisting rule and draft PDM plan. We received responses from one of the peer reviewers.

We reviewed all comments received from the peer reviewer for substantive issues and new information regarding the delisting rule and PDM plan for the Monito gecko. The peer reviewer generally concurred with our methods and conclusions and provided additional information, clarifications, and suggestions to improve the final delisting rule. Peer reviewer comments are summarized below and incorporated into the final rule as appropriate.

(1) Comment: The peer reviewer mentions that the evidence for the success of the Monito rat eradications is strong, but not compelling. The reviewer specified that, given the multiple trips to Monito Island with uniformly negative results, eradication success is the most likely explanation, but longer term monitoring would elevate confidence in this conclusion.

Our response: Since the rat eradication campaign in 1999, no rats have been detected on Monito Island. Based on the information available and consistent with the peer reviewer's interpretation of the evidence, is it highly unlikely there are still rats on Monito, unless there has been a reinvasion after May 2016, which is also unlikely. In addition, if rats had been present during our 2014 and 2016 trips we would likely have detected them, given the number of persons out at night searching for geckos, the relatively small size of the island, the rat detection devices used, and the scraps of food left out on purpose in the camp area. None of these methods produced even a suspicion of rats being present. Based on the best available information, the Service and its partners concluded that eradication was successful in 1998-1999.

(2) Comment: The peer reviewer mentioned that the gecko abundance estimate is based on a model that is reasonable but that has not been validated for this population. Several other commenters questioned the validity of the model used for the population estimate. They stated that the model was inaccurate and the estimated abundance was extremely biased and does not meet the assumptions of the model specified. Specifically, the model is intended for multi-temporal replication. Commenters explained that the Service is relying on just a single visit survey in its erroneous estimates that have overly broad confidence limits and high statistical error.

Our response: The Service used abundance modeling based on repeated surveys across multiple days across multiple sites. Specifically, we observed 84 geckos during 96 surveys among 40 plots across two nights. The high numbers of geckos detected (84) during the 96 surveys during the 2016 site visit was the first systematic attempt to survey the Monito gecko population. Recommendations for future survey efforts have been noted; for example, marking plots more visibly (Island Conservation 2016). During the development of the model and survey methods, the Service wanted methods and models that can be replicated in order to adjust and improve the abundance estimates accordingly over time ( i.e., validate). Per our Post-Delisting Monitoring Plan, we recommend conducting surveys every other year for the next 5 years.

For a complete review of the methods and results, a copy of Island Conservation (2016) report is available at http://www.regulations.gov in Docket No. FWS-R4-ES-2017-0082. In addition, the methods and a reproducible code set are freely available online at: https://github.com/nangeli1/Contracts.

(1) Comment: One commenter asked the Service to explain the process for finding independent specialists when soliciting expert opinion for peer review.

Our response: In accordance with our joint policy on peer review published in the Federal Register on July 1, 1994 (59 FR 34270) and our August 22, 2016, memorandum updating and clarifying the role of peer review of listing actions under the Act, we sought the expert opinions of seven reviewers. We are required by our peer review policy to find at least three peer reviewers, and we often choose more than three if they are available. In doing so, the Service looked for experts in the species, including its life history, habitat and threats that it may face. The experts cannot have been involved in the production of the draft rule.

(2) Comment: The peer reviewer stated that the Service does not have a population trajectory for this species, but rather only a single snapshot in time. Several other commenters also recommended that more surveys are needed to assess population trends before delisting, as well as more ecological studies.

Our response: Gecko detections during 2014 and the 2016 survey provide substantial evidence that the species is consistently abundant and widespread across the island. Further, our analysis of the listing factors shows how the Service determined that the Monito gecko should be delisted, and survey information is just one of the parameters used to make that determination. Ultimately, there is no indication that any of the threats are operating on the population at levels that meet an endangered or threatened species as defined under the Act. In addition, conducting ecological studies was considered in the species Recovery Plan (1986). However, based on the most recent observations, achievement of the most critical recovery actions ( i.e., rat eradication and survey), and our 5-factor analysis, we have determined that no additional ecological studies are needed to determine the listing status for this species. Future needs for studies, status evaluations, and recommendations will be addressed with the Post-Delisting Monitoring Plan and its primary goal of monitoring to ensure the status of the species does not deteriorate and, if a substantial decline in the species population size or an increase in threats is identified, to enact measures to halt and reverse unfavorable trends.

(3) Comment: Several commenters specified that there is evidence-based support that climate change will impact S. micropithecus and provided scientific articles to support their claim.

Our response: In our proposed rule, we analyzed the potential effects of climate-related sea-level rise on the Monito gecko and determined that it was not a threat to the species because the topography of Monito Island will insulate the species from the effects of sea-level rise. We asked the public to provide any data or new information particularly on the possible effects of climate change to the Monito gecko. Based on the comments and information received, we evaluated new information and conducted a thorough review of the relevant literature. We continue to conclude that climate change does not constitute a threat to the species to the extent that it is endangered or threatened throughout all or a significant portion of its range (Refer to Factor E, below, for a discussion of the potential implications of climate change on the Monito gecko).

(4) Comment: One commenter opined that lack of genetic analysis hinders the Service's ability to assess effective population size, inbreeding rates, deleterious alleles, and any proactive genetic rescue plans.

Our response: The Service recognizes that this determination does not include a genetic analysis of the Monito gecko population but has determined that one is not needed. The fact that the species is found throughout Monito Island in the thousands, and that juveniles and gravid females were found (past and most current surveys), all demonstrate a large well-represented population with abilities to recover and adapt from disturbances. Thus, there do not seem to be any perceptible indications that a lack of genetic representation is causing species mortality or limiting the species' ability to adapt or reproduce. Still, any potential genetic rescue plan would need to consider that the Monito gecko population is endemic, closed to immigration from other Sphaerodactylus species, and has been isolated for millions of years.

(5) Comment: Several commenters request the Service recognize the severe vulnerability of Monito Island and its inhabitants to catastrophic events such as hurricanes and fires.

Our response: Catastrophic events such as fires or hurricanes were discussed under Factors A and E, respectively. Neither of these factors were found to be operating currently, or are expected to be found in the foreseeable future, on the Monito gecko population to require its continued listing under the Act. In addition, even though several hurricanes have potentially affected Monito Island in the past, the species remains abundant and widespread throughout the island. The recent Hurricane Maria (Sept. 2017), which caused extensive damage in Puerto Rico, did not cause significant damage to Monito Island.

The Monito gecko, Sphaerodactylus micropithecus, (Schwartz 1977, entire) is a small lizard (approximately 36 millimeters (1.42 inches) snout-vent length) with an overall pale-tan body and dark-brown mottling on the dorsal surface. It is closely related to the Sphaerodactylus macrolepis complex of the Puerto Rican Bank, but variation in dorsal pattern and scale counts confirm the distinctiveness of the species; probably resulting from a single invasion to Monito Island and its subsequent isolation (Schwartz 1977, p. 990, Dodd and Ortiz 1984, p. 768). Little is known about the biology of this species, including its diet, reproduction, or potential predators. Other more common Sphaerodactylus species in Puerto Rico eat a diverse content of small invertebrates, such as mites, springtails, and spiders (Thomas and Gaa Kessler 1996, pp. 347-362). Out of the 18 individuals counted by Dodd and Ortiz (1983, p. 120), they found juveniles and gravid females suggesting that the species was reproducing. Dodd and Ortiz (1983, p. 121) suspected reproduction occurs from at least March through November as suggested by the egg found by Campbell in May 1974, by the gravid females found by Dodd and Ortiz (1982, p. 121) in August 1982, and the fact that Monito gecko eggs take 2 to 3 months to hatch (Rivero 1998, p. 89). During a plot survey in May 2016, two gravid females and several juveniles were found (USFWS 2016, p. 13). Potential natural predators of the Monito gecko may include the other native lizard Anolis monensis and/or the Monito skink ( Spondilurus monitae ).

The Monito gecko is restricted to Monito Island, an isolated island located in the Mona Passage, about 68 km (42.3 mi) west of the island of Puerto Rico, 60 km (37.3 mi) east of Hispaniola and about 5 km (3.1 mi) northwest of Mona Island (USFWS 1986, p. 2). Monito Island is a flat plateau surrounded by vertical cliffs rising about 66 m (217 ft) with no beach and is considered the most inaccessible island within the Puerto Rican archipelago (Garcia et al. 2002, p. 116). With an approximate area of 40 acres (c.a. 16 hectares) (Woodbury et al. 1977, p. 1), Monito Island is part of the Mona Island Reserve, managed for conservation by the PRDNER (no date, p. 2). The remoteness and difficulty of access to Monito Island make studying the Monito gecko difficult (Dodd 1985, p. 2).

The only life zone present on Monito Island is subtropical dry forest (Ewel and Whitmore 1973, p. 10). In this life zone, the Monito gecko has been found in areas characterized by loose rock sheets or small piles of rocks, exposed to the sun, and with little or no vegetation cover. Vegetation may or may not be associated with these areas. On Monito Island, such areas include small groves of Guapira discolor (barrehorno), Pithecellobium unguis-cati (escambrn colorado), or Capparis flexuosa (palo de burro) where some leaf litter is present; areas with loose rocks on the ground; or rock sheets that provide shady refuges, and numerous regions where large pieces of metal (remnant ordnance) lay on the ground (Ortiz 1982, p. 2). Being a small, ground-dwelling lizard, the Monito gecko, like other members of its genus, is usually found under rocks, logs, leaf litter, and trash (Rivero 1998, p. 89).

When the species' recovery plan was completed in 1986, only two island-wide surveys had been completed (Dodd and Ortiz 1983, entire; Hammerson 1984, entire), with the higher count from Dodd and Ortiz (1983, p. 120) reporting a total of 18 geckos during a 2-day survey. During both of these surveys, all geckos were found during the day and under rocks. Subsequent surveys of variable length and area covered detected from 0 to 13 geckos during the day as well (PRDNER 1993, pp. 3-4; USFWS 2016, p. 9).

These previous attempts to survey for the Monito gecko are considered underestimates, because the surveys were done during the day when the species is more difficult to detect: It seems to be less active and mostly hiding under rocks, debris, crevices, or other substrates. Although geckos in the Sphaerodactylinae group are considered mostly diurnal or crepuscular (Rivero, p. 89; Pianka and Vitt 2003, p. 185), we suspect that the Monito gecko is more active at night and thus easier to detect during night surveys. This nocturnal behavior was confirmed during a May 2014 rapid assessment and a May 2016 systematic survey. During the May 2014 rapid assessment, at least one gecko was seen during each of the three nights of the trip; some encounters were opportunistic, and others occurred while actively searching for the species (USFWS 2016, p. 9). In fact, no geckos were seen during daylight hours. Geckos were seen on exposed substrates and not hidden under rocks or litter, although some were seen within leaf litter mixed with rocks under a Ficus citrifolia tree. Geckos were observed escaping into the cracks and solution holes of the limestone rock.

The May 2016 systematic gecko survey involved setting up of 40 random plots on Monito Island (USFWS 2016, p. 10). Each plot was 20 m × 20 m (400 m 2 ), so that the survey covered a total of 16,000 m 2 or approximately 11 percent of Monito Island. Four two-person teams visited 10 plots each. Each observer surveyed each plot independently. All sites were surveyed at least twice, and all took place during the night. A total of 84 geckos were observed during 96 surveys among the 40 plots, most on exposed rock. Only 8 out of the 84 counted were found under a rock or other substrate; all others were out during the night. Only two geckos were opportunistically found during the day while observers were turning rocks and dry logs.

Gecko occupancy and abundance were estimated using a standard mathematical population model accounting for the abundance and detection bias that allows individuals to go unseen during surveys (Island Conservation (IC) 2016, p. 5). Occupancy of the geckos on Monito Island was determined to be 27.8 percent (confidence interval 11.3-68.6 percent). The mean number of geckos per plot was 73.3 (Range: 1-101). The abundance model indicates a total of 1,112 geckos present within the surveyed plots (95 percent confidence interval: 362-2,281). Extrapolated across the entire island, Monito Island hosts approximately 7,661 geckos (50 percent confidence interval: 5,344-10,590).

Section 4(f) of the Act directs us to develop and implement recovery plans for the conservation and survival of threatened and endangered species unless we determine that such a plan will not promote the conservation of the species. Recovery plans are not regulatory documents and are instead intended to establish goals for long-term conservation of a listed species, define criteria that are designed to indicate when the threats facing a species have been removed or reduced to such an extent that the species may no longer need the protections of the Act, and provide guidance to our Federal, State, and other governmental and nongovernmental partners on methods to minimize threats to listed species. There are many paths to accomplishing recovery of a species, and recovery may be achieved without all recovery criteria being fully met. For example, one or more criteria may have been exceeded while other criteria may not have been accomplished or become obsolete, yet the Service may judge that, overall, the threats have been minimized sufficiently, and the species is robust enough, to reclassify the species from endangered to threatened or perhaps delist the species. In other cases, recovery opportunities may have been recognized that were not known at the time the recovery plan was finalized. These opportunities may be used instead of methods identified in the recovery plan.

Likewise, information on the species may subsequently become available that was not known at the time the recovery plan was finalized. The new information may change the extent that criteria need to be met for recognizing recovery of the species. Recovery of species is a dynamic process requiring adaptive management that may, or may not, fully follow the guidance provided in a recovery plan.

The following discussion provides a brief review of recovery planning and implementation for the Monito gecko, as well as an analysis of the recovery criteria and goals as they relate to evaluating the status of the taxon.

The Monito Gecko Recovery Plan (Plan) was approved on March 27, 1986 (USFWS 1986, entire). The objective of the Plan was to conduct a systematic status survey and ecological study of the species, and to reevaluate the species' status and formulate a quantitative recovery level and specific recovery actions (USFWS 1986, p. 7). This Plan is considered outdated and does not contain recovery criteria that could lead to delisting the Monito gecko. However, the Plan does provide recovery objectives that, when accomplished, would aid in developing such criteria. No quantitative recovery level was defined due to the lack of data on historical population levels, population trends, and apparent historical population size. The objectives were accomplished as follows:

The Plan identifies five primary recovery actions:

(1) Determine the status of the present population;

(2) Conduct basic ecological studies;

(3) Determine extent, if any, of predation and competition by rats and other native lizards (see Factor C);

(4) Update the Plan; and

(5) Continue protection of the present population.

The following discussion provides specific details for each of these actions.

Recovery action 1: Determine the status of the species.

From 1982 to 1993, several Monito gecko surveys were conducted (USFWS 2016, p. 9). However, some of these surveys were either done before the Plan was completed (USFWS 1986) or did not provide enough information to answer the population objectives of the Plan, and current information (see Population Size and Trends above) suggests that surveys underestimated the number of geckos. Data from the 2014 rapid assessment and the 2016 systematic plot survey show that, overall, the Monito gecko is abundant across the whole island and numbers in the thousands, indicating a large healthy population, as specified in the Species Information section above.

Recovery action 2: Conduct basic ecological studies.

Besides the population survey efforts, no basic ecological studies have been conducted for the Monito gecko. Conducting ecological studies, as described in the Plan (USFWS 1986, pp. 7-8), is not crucial to further assess the species' listing status. There is no indication that ecological factors such as habitat preferences (species occurs throughout the island) and fluctuations in reproductive biology or activity patterns (both unknown), are critical for the species' listing status. The adjustment of surveys from diurnal to nocturnal was a key factor for researchers to discover in order to obtain reliable data and provide optimal population information. We will further discuss any possible needs of ecological evaluations in relation to post-delisting monitoring with our partners, but we will likely not need detailed research on the gecko's ecology based on the status of threats in its native habitat on Monito Island.

Recovery action 3: Determine the extent, if any, of predation and competition by rats and native reptiles.

At the time of listing, the presence of rats on Monito Island was identified as the main threat to the Monito gecko. This threat was suspected to be the main cause of an apparent population decline for the Monito gecko, since rats are effective predators and are known to feed on both lizards and lizard eggs (Dodd and Ortiz 1983, p. 120; Case and Bolger 1991, pp. 273-278). However, the net effect, if any, of the potential rat predation on the geckos is debatable. For example, in comments quoted in the final listing rule (47 FR 46091, October 15, 1982), Dr. H. Campbell indicated that the scarcity of the Monito geckos was an artifact of the intense predation by black rats ( Rattus rattus ), while Dr. A. Schwartz expressed doubts that rats could have any effect on the gecko or its eggs. Dodd and Ortíz (1983, p. 121) also explained that, during their surveys, predator pressure on the gecko could not be proven and that more studies were needed to determine if rats or other predators do affect the Monito gecko. The potential effect of rats on two other relatively common small geckos ( Sphaerodactylus monensis and Sphaerodactylus levinsi ) on nearby Mona and Desecheo Islands (respectively) is also unknown. Nevertheless, there is ample evidence that the Monito gecko would fare better without rats (Case and Bolger 1991, entire; Towns et al. 2006, entire; Jones et al. 2016, entire; Thibault et al. 2017, entire).

In October 1992, the PRDNER began a black rat eradication and survey project on Monito Island to benefit native and endemic species on that Island (García et al. 2002, p. 116). The eradication campaign continued in March 1993 with poisoning (rodenticide) and snap traps to assess changes in the rat population. A second eradication campaign started in October 1998, with three eradication events at 4-month intervals, and again using, in addition to snap traps, chew blocks ( i.e., soft wood pieces soaked in canola oil) as a monitoring tool.

García et al. (2002, pp. 117-118) evaluated the status of the rat population seven times during the first campaign and five times during the second campaign. Since the completion of the second eradication campaign (August 1999), no rats have been detected on Monito Island. García et al. (2002, p. 118) concluded that in order to be certain that eradication had been achieved, it was essential to continue an appropriate rat monitoring program on the island, and recommended using chew blocks. However, no systematic rat monitoring has been implemented on the island since September 1999. Nonetheless, during a seabird blood sampling trip in August 2000, Anderson and Steeves (2000, p. 1) reported not seeing any rats on Monito Island, as did subsequent PRDNER bird survey trips in 2003.

On May 2014, the Service organized an expedition to Monito Island with the PRDNER in order to confirm the eradication of black rats from the island, and to evaluate the status of and threats to the Monito gecko. The Service and the PRDNER placed 27 snap traps and 70 chew blocks distributed along transects covering 870 meters in length (USFWS 2016, p. 7). In addition, some food items ( i.e., watermelon, left-over canned food) were intentionally left exposed and available for rats. No signs of rats were detected on these available sources during this 4-day/3-night trip. During surveys conducted in May 2016, the Service and the PRDNER also placed 80 chew blocks, two within each gecko sampling plot (USFWS 2016, p. 10). No rats were seen or detected with the chew blocks during this 5-day/4-night trip. This is a marked contrast from when the species was listed in 1982, when rats were observed island-wide at all times during a 2-day expedition (47 FR 46090, October 15, 1982).

In short, although it cannot be ascertained when the last rat died, Monito Island appears to have been rat free since August-September 1999. Thus, the suspected main threat to the species has not been present for at least the past 18 years.

Other lizards ( i.e., Anolis monensis and Spondilurus monitae, formerly Mabuya mabouya sloani ) that naturally occur on the Island may also prey on the Monito gecko. These other species are considered diurnal (active during the day), while the Monito gecko is considered nocturnal (active during the night). Determining the extent of these potential predator-prey interactions would be challenging. However, this should no longer be necessary, as the species has persisted despite potential predatory threats.

Recovery action 4: Update Recovery Plan.

Because of the information on threats and recovery progress that is provided in the Monito gecko 5-year review (USFWS 2016) and this final rule, the Monito gecko no longer meets the definition of an endangered or threatened species. Therefore, a formal update of the 1986 Plan is not needed.

Recovery action 5: Continue protection of the present population.

Monito Island has been protected by the PRDNER as a nature reserve since 1986 (PRDNER, no date, p. 2). There are no permanent human residents on Monito Island and access is allowed only under special permits issued by the PRDNER, which also maintains a ranger detachment and biologist on nearby Mona Island. Monito Island is also visited by illegal immigrants. The frequency of these events varies from year to year, and illegal immigrants are evacuated fairly quickly by the U.S. Coast Guard. Furthermore, the impacts of these visitations seem to be minimal (see discussion below).

Section 4 of the Act and its implementing regulations (50 CFR part 424) set forth the procedures for listing, reclassifying, or removing species from the Federal List of Endangered and Threatened Species. “Species” is defined by the Act as including any species or subspecies of fish or wildlife or plants, and any distinct vertebrate population segment of fish or wildlife that interbreeds when mature (16 U.S.C. 1532(16)). Once the species is determined, we then evaluate whether that species may be an endangered species or a threatened species because of any of one or a combination of the five factors described in section 4(a)(1) of the Act:

(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.

We must consider these same five factors in reclassifying or delisting a species. In other words, for species that are already listed as endangered or threatened, the analysis for a delisting due to recovery must include an evaluation of the threats that existed at the time of listing, the threats currently facing the species, and the threats that are reasonably likely to affect the species in the foreseeable future following the delisting or downlisting and the removal of the Act's protections.

The following discussion examines the factors that were believed to affect the Monito gecko at the time of its listing, are currently affecting it, or are likely to affect the Monito gecko within the foreseeable future.

At the time of listing (47 FR 46090, October 15, 1982), the destruction, modification, or curtailment of its habitat was not considered a threat to the Monito gecko. In 1940, the U.S. Government acquired Monito Island, and the entire island was used by the Air Corps/U.S. Air Force as a high-level radar bombing and gunnery range (Parsons Corp. 2010, pp. 2-5). In 1961, Monito Island was declared surplus and was returned to the Commonwealth of Puerto Rico in September 1965 (Parsons Corp. 2010, pp. 2-5). Monito Island is managed by the PRDNER for conservation as part of the Mona Island Reserve (PRDNER, no date, p. 2). The final listing rule indicated that there were no plans to continue to use Monito Island for bombing practices at the time, and any major alteration of the island could be detrimental to the continued survival of the Monito gecko. In fact, the large amount of scattered debris on Monito Island suggests significant historical habitat modification from bombing activities (USFWS 1986, p. 5).

A Monito Island site inspection was conducted in August 2009 (Parsons Corp. 2010, entire). A qualitative reconnaissance and munitions constituents sampling was performed to confirm the range location and to evaluate the potential presence of munitions and explosives of concern (Parsons Corp. 2010, p. ES-1). Although unexploded ordnance (UXO) and munitions debris was found on Monito Island, immediate munitions removal actions were not warranted.

The potential for future UXO detonation activities may have an effect on the Monito gecko and its critical habitat. Since Monito Island is a natural reserve, all activities must be coordinated with the PRDNER. The Service has been conducting informal consultations with the U.S. Army Corps of Engineers in order to develop species-specific standard operating procedures (SOPs) for the Monito gecko and other federally listed species that occur on Monito Island. These site-specific SOPs would be considered the appropriate conservation measures required to avoid and minimize potential adverse effects on the species or its critical habitat. Based on the current consultation, the magnitude of threat of these future U.S. Army Corps of Engineers' actions on the Monito gecko is considered minimal and non-imminent (USCOE 2017).

Monito Island receives illegal immigrants, usually from the western islands of Cuba and Hispaniola, that are trying to enter U.S. territory. The PRDNER has stated that illegal immigrants sometimes light fires on Monito Island in order to be detected and rescued. This information was documented during the May 2016 trip, where two recent fire pits were found, along with a small pile of firewood cuttings, on the south-southeast side of the island on exposed rock with no vegetation in the immediate vicinity. The presence of fire pits on Monito Island had not been documented in the past. At least for the two fire pits found in May 2016, their placement and construction demonstrates these were controlled fires and their intention was not of criminal nature. Although there is no information available on the frequency and damage these fires may be causing, based on what was documented in May 2016, the potential effects of such fires may also be considered minimal. To date, there is no indication that any potential fires have spread throughout the Island.

The final listing rule (47 FR 46091, October 15, 1982) mentioned that, because of the rarity of the Monito gecko, removal of specimens could be detrimental. At present, we are not aware of any individuals taken after listing for commercial, recreational, scientific, or educational purposes. The remoteness and difficult access of Monito Island limits any collecting efforts. In addition, access is only allowed under special permits issued by the PRDNER, mostly for research, security, or management purposes. Furthermore, the Monito gecko's apparent rarity may have been an artifact of sampling bias, because surveys from 1982 to 1993 were done during daylight hours when the species is mostly hiding and the species has a low detection probability (see Species Information section).

The final listing rule (47 FR 46091, October 15, 1982) indicates that the presence of large numbers of introduced black rats was thought to be the major factor in the precarious state of the Monito gecko because, although predation by black rats on this species has not been confirmed, rats are predaceous and are known to feed on both lizards and lizard eggs (Dodd and Ortiz 1983, p. 120; Case and Bolger 1991, pp. 273-278). Thus, predation by rats was considered a possible cause of population decline for the Monito gecko (USFWS 1986, p. 5). As previously explained above under Recovery Action 3, Monito Island has been rat free since August-September 1999. Thus, the main threat to the species has not been present for at least the past 18 years.

Although Monito Island is currently rat free, there is still the possibility that rats could reach the island again. Rats may be transferred from Mona Island by floating debris or more likely by human means. In addition to illegal immigrants, as discussed above, there is limited evidence of public use of Monito Island for recreational or unknown purposes. Although it is logistically difficult to disembark on the island and prohibited because of unexploded ordinances from the previous military activities, these disembarking events could increase the chance of invasion and establishment of rats or other exotic species. However, this possibility is considered very low. The rat eradication campaign was completed in 1999, and 18 years later, no rats have been found.

Ortiz (1982, p. 7) included the endemic Monito skink Spondilurus monitae (formerly Mabuya mabouya sloani ) as a potential predator of the Monito gecko. Other species of Mabuya feed primarily on small invertebrates, but the diversity of prey types in stomach contents, including small vertebrates, indicates that some skink species (such as M. bistriata ) most likely feed on any moving animal of the appropriate size (Vitt and Blackburn 1991, p. 920). Mabuya mabouya live in places where Sphaerodactylus abound (Rivero 1998, p. 106) and it is probable that geckos constitute an important food item for this skink. During the 2016 trip, biologists observed one adult skink active at night within the same exposed rock habitat used by the Monito gecko ( i.e., exposed karst rock with lots of crevices and holes). It is also highly probable that another native lizard, Anolis monensis, will prey on the Monito gecko as well, except that Anolis are considered diurnal. The Monito gecko's trait of tail autotomy (tail loss) is certainly an effective predator defense mechanism (Pianka and Vitt 2003, p. 76). During our May 2014 site visit, 2 out of the 8 geckos captured for measurements were missing the tips of their tails, and during May 2016, only 5 geckos out of the 84 seen had missing tail parts. Although difficult to determine, this suggests natural predation pressure from the two other native lizard species mentioned above is low.

When the Monito gecko was listed (47 FR 46091; October 15, 1982), the species did not have any other statutory or regulatory protections. Now, territorial laws and regulations protect the Monito gecko. In 1999, the Commonwealth of Puerto Rico enacted Law No. 241-1999, known as the New Wildlife Law of Puerto Rico ( Nueva Ley de Vida Silvestre de Puerto Rico ). The purpose of this law is to protect, conserve, and enhance both native and migratory wildlife species; declare property of Puerto Rico all wildlife species within its jurisdiction; provide provisions to issue permits; regulate hunting activities; and regulate exotic species, among other actions. In 2004, the PRDNER approved Regulation 6766—to regulate the management of threatened and endangered species in Puerto Rico ( Reglamento 6766—Reglamento para Regir el Manejo de las Especies Vulnerables y en Peligro de Extinción en el Estado Libre Asociado de Puerto Rico ), including the Monito gecko, which was listed as endangered. Article 2.06 of this regulation prohibits collecting, cutting, removing, among other activities, listed animals within the jurisdiction of Puerto Rico. There is no evidence that either the law or the regulation is not being adequately implemented.

Additionally, the PRDNER has managed Monito Island as a natural reserve since 1986, protecting its wildlife and vegetation. Monito Island is managed for conservation because it harbors one of the largest seabird nesting colonies in the Caribbean, in addition to other endemic and federally listed species like the Higo chumbo cactus ( Harrisia portoricensis ) and the yellow-shouldered blackbird ( Agelaius xanthomus ). No human permanent residents live on the island, and public access is prohibited. The best available information indicates that Monito Island will remain permanently protected as a nature reserve and managed for conservation. In addition, Monito Island harbors additional species protected by the ESA and the Migratory Bird Treaty Act. Any potential future federal actions on Monito Island will still require consultation with the USFWS for those species ( e.g., Harrisia cactus, Yellow-shouldered black bird), thereby potentially also benefiting the Monito gecko from conservation measures developed for those other species.

In listing the Monito gecko, we considered as a factor the species' extremely small population size (47 FR 46090, October 15, 1982). As previously explained in Species Information and Recovery and Recovery Plan Implementation, the Monito gecko is a small and cryptic species and difficult to detect, especially during the day. However, all of the historical surveys documented (USFWS 2016, p. 9) were done during daylight hours, when the species is apparently less active, safely hiding from diurnal native reptile predators, and/or exhibiting behavioral adaptations to avoid the hot temperatures within its xeric dry forest environment. As discussed above (see Population Size and Trends), these and other biases cause us to question the validity of these historical surveys. In contrast, as also discussed above (see Population Size and Trends), the best available population estimate for the species, completed during the May 2016 systematic plot survey, shows that the Monito gecko is widely distributed throughout Monito Island and gecko abundance appears to number in the thousands, indicating a large well-represented population (IC 2016, pp. 5-6). Our post-delisting monitoring will demonstrate the continued recovery of this species. In general, lizard populations remain fairly stable and are influenced by predation and amount of resources available, and predation and competition usually result in populations existing below their carrying capacity (Pianka and Vitt 2003, p. 64). Based on the May 2014 and 2016 observations and results, there is no indication that limited resources are acting on the population to warrant listing under the Act.

Potential sea level rise as a result of climate change is not a threat to this species or its habitat, because the Monito gecko is found only on Monito Island, which is 66 m (217 ft) above sea level and has no beach areas. The current rate of sea level rise in the Caribbean is 10 cm (3.9 inches) per century, with more specific sea level rise estimates for Puerto Rico ranging from 0.07 to 0.57 meters (m) (0.20 to 1.87 feet) above current sea level by the year 2060 and between 0.14 to 1.70 m (0.40 to 5.59 feet) by the year 2110 (Puerto Rico Climate Change Council 2013, p. 64). Thus, the habitat occupied by the Monito gecko will remain well above the area of Monito Island predicted to be affected by sea-level rise in the foreseeable future.

Hurricanes, such as the recent Hurricanes Irma and Maria are not considered a threat to the Monito gecko in part because the island is 66 m above sea level. The vegetation on the island is short and therefore hurricane impacts are expected to be minimal. Additionally, the Monito gecko is adapted to living under cover mostly during the day when the species seems to be less active. Typical forms of cover include rocks, debris, crevices, or other substrates.

We further evaluated the potential effects of the predicted scenario of a gradual trend toward a dryer and hotter climate for Puerto Rico (Henareh et al. 2016, p. 265; Bhardwaj et al. 2018, pp. 133-134). To a certain extent, evaluating the vulnerability of the Monito gecko to climate change would require linking the magnitude of changes ( i.e., temperature and humidity) with the physiological response of the species to those changes (Deutsch et al. 2008, p. 6668; Huey et al. 2009, p. 1; Glick et al. 2011, pp. 39-43; Pacifici et al. 2015, p. 215). For example, the fact that Sphaerodactylus are particularly vulnerable to overheating and desiccation is an important criterion to evaluate.

Based on the available information, the Monito gecko should have low evaporative water loss rates, with behavioral adaptions similar to other Sphaerodactylus (or other lizards) that exploit arid microhabitats (Snyder 1979, p. 110; Dunson and Bramham 1981, pp. 257-258; Nava 2001, pp. 461-463; López-Ortiz and Lewis 2004, p. 438; Nava 2004, pp. 18-26; Steinberg et al. 2007, pp. 334-335; Turk et al. 2010, pp. 128-129; Bentz et al. 2011, pp. 46-47; Allen and Powell 2014, pp. 594-596). Research suggests that these tiny lizards have behavioral and physiological traits that allow them to acclimate to and survive under each particular local environment and climate. In the case of the Monito gecko, the species usually hides and is undetectable during the day (unless an active search of turning rocks and debris is conducted) and shifts to a more active and detectable lifestyle during the night. This is consistent with microhabitat selection and activity patterns exhibited by other Sphaerodactylus lizards to minimize exposure to physiologically challenging diurnal conditions of lower humidity and higher temperatures. Cover during the day not only provides insulation from higher temperatures, but also protection from predators such as the relatively abundant Anole lizard on Monito Island. In addition, Sphaerodactylus eggs are considered extremely resistant to dessication (Dunson and Bramham 1981, p. 255).

Without any specific climate change studies for the Monito gecko, it is difficult to predict with certainty how the Monito gecko will respond to predicted climate change scenarios and how they might affect the species' fitness and viability. Some researchers suggest that climate change will increase the thermal stress on tropical lizards, suggesting a detrimental effect on the basic physiological functions of these ectotherms (Deutsch 2008, entire; Tewksbury 2008, entire; Huey et al. 2009, entire). However, with the current absence of other potential threats ( e.g., habitat loss, disease, rat predation, etc.) and the perpetual legal protection of the species and its habitat as a nature reserve, the Monito gecko should have the best opportunity to survive and adapt well past the foreseeable future. Thus, we do not expect the Monito gecko to be endangered nor threatened currently or in the foreseeable future by potential climate change effects.

Under section 4(a)(1) of the Act, we determine whether a species is an endangered species or threatened species because of any one or a combination of the following: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) Overutilization for commercial, recreational, scientific, or educational purposes; (C) Disease or predation; (D) The inadequacy of existing regulatory mechanisms; or (E) Other natural or manmade factors affecting its continued existence. The Act defines an endangered species as any species that is “in danger of extinction throughout all or a significant portion of its range” and a threatened species as any species “which is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.”

As required by section 4(a)(1) of the Act, we conducted a review of the status of this species and assessed the five factors to evaluate whether it is in danger of extinction currently or likely to become so in the foreseeable future throughout all of its range. The Monito gecko is endemic to Monito Island, a small island (approx. 40 acres; 16.2 hectares) off the west coast of Puerto Rico, and it has not been introduced elsewhere. There are no landscape barriers within Monito Island that might be of biological or conservation importance. The most recent survey found that the species occurs across most of the Island. The basic ecological components required for the species to complete its life cycle are considered present throughout Monito Island. We found that Monito gecko populations are persistent with an estimate of approximately 7,661 geckos (50 percent confidence interval: 5,344-10,590). During our analysis, we found that impacts thought to be threats at the time of listing (primarily predation by rats, factor C) are either not as significant as originally anticipated or have been eliminated or reduced since listing, and we do not expect any of these conditions to substantially change post-delisting and into the foreseeable future, nor do we expect climate change to affect this species in the foreseeable future. We conclude that the previously recognized impacts ( i.e., rat predation, small population size) to the Monito gecko no longer threaten the species, such that the species is no longer in danger of extinction throughout all of its range now or in the foreseeable future. In order to make this conclusion, we analyzed the five threat factors used in making Endangered Species Act listing (and delisting) decisions. This analysis indicates that the Monito gecko is not in danger of extinction throughout all of its range, nor is it likely to become so in the foreseeable future.

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 (SPR). Where the best available information allows the Services to determine a status for the species rangewide, that determination should be given conclusive weight because a rangewide determination of status more accurately reflects the species' degree of imperilment and better promotes the purposes of the Act. Under this reading, we should first consider whether the species warrants listing “throughout all” of its range and proceed to conduct a “significant portion of its range” analysis if, and only if, a species does not qualify for listing as either an endangered or a threatened species according to the “throughout all” language.

Having determined that the Monito gecko is not in danger of extinction now or likely to become so in the foreseeable future throughout all of its range, we now consider whether it may be in danger of extinction or likely to become so in the foreseeable future in an SPR. The range of a species can theoretically be divided into portions in an infinite number of ways, so we first screen the potential portions of the species' range to determine if there are any portions that warrant further consideration. To do the “screening” analysis, we ask whether there are portions of the species' range for which there is substantial information indicating that: (1) The portion may be significant; and (2) the species may be, in that portion, either in danger of extinction or likely to become so in the foreseeable future. For a particular portion, if we cannot answer both questions in the affirmative, then that portion does not warrant further consideration and the species does not warrant listing because of its status in that portion of its range. We emphasize that answering these questions in the affirmative is not a determination that the species is in danger of extinction or likely to become so in the foreseeable future throughout a significant portion of its range—rather, it is a step in determining whether a more detailed analysis of the issue is required.

If we answer these questions in the affirmative, we then conduct a more thorough analysis to determine whether the portion does indeed meet both of the SPR prongs: (1) The portion is significant and (2) the species is, in that portion, either in danger of extinction or likely to become so in the foreseeable future. Confirmation that a portion does indeed meet one of these prongs does not create a presumption, prejudgment, or other determination as to whether the species is an endangered species or threatened species. Rather, we must then undertake a more detailed analysis of the other prong to make that determination. Only if the portion does indeed meet both SPR prongs would the species warrant listing because of its status in a significant portion of its range.

At both stages in this process—the stage of screening potential portions to identify any portions that warrant further consideration and the stage of undertaking the more detailed analysis of any portions that do warrant further consideration—it might be more efficient for us to address the “significance” question or the “status” question first. Our selection of which question to address first for a particular portion depends on the biology of the species, its range, and the threats it faces. 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 second question for that portion of the species' range.

For Monito gecko, we chose to evaluate the status question ( i.e., identifying portions where the Monito gecko may be in danger of extinction or likely to become so in the foreseeable future) first. To conduct this screening, we considered whether the threats are geographically concentrated in any portion of the species' range at a biologically meaningful scale. If a species is not in danger of extinction or likely to become so in the foreseeable future throughout all of its range and the threats to the species are essentially uniform throughout its range, then the species would not have a greater level of imperilment in any portion of its range than it does throughout all of its range and therefore no portions would qualify as an SPR.

We examined the following threats: The destruction and modification of habitat by humans and exotic foreign species introduced to the Monito Island, such as rats and mice, including cumulative effects. We found no concentration of threats in any portion of the Monito gecko's range at a biologically meaningful scale. Since we found no portions of the species' range where potential threats are significantly concentrated or substantially greater than in other portions of its range, we did not identify any portions where the species may be in danger of extinction or likely to become so in the foreseeable future. Therefore, no portions warrant further consideration through a more detailed analysis, and the species is not in danger of extinction or likely to become so in the foreseeable future in any significant portion of its range. Our approach to analyzing SPR in this determination is consistent with the court's holding in Desert Survivors v. Department of the Interior, No. 16-cv-01165-JCS, 2018 WL 4053447 (N.D. Cal. Aug. 24, 2018).

Our review of the best available scientific and commercial information indicates that the Monito gecko is not in danger of extinction nor likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. Therefore, we find that listing the Monito gecko as an endangered species or a threatened species under the Act is not warranted at this time.

The Monito gecko has demonstrated the ability to persist despite changing environmental conditions over time from both anthropogenic and natural disturbances. Although the Monito gecko population is considered to have low redundancy ( i.e., one population endemic to Monito Island), no risk of extirpation was identified and no other populations outside of Monito Island are needed for its recovery. In addition, the fact that the species was found throughout the Island, gecko abundance is in the thousands, and past and current occurrence of juveniles and gravid females, indicates a large, well-represented population with demonstrated abilities to recover and adapt from disturbances.

Because the Monito gecko population is considered self-sustaining, contains a large number of individuals, and has demonstrated high resilience and viability, we expect this population to persist into the future. The species is considered abundant within its habitat, which consists of adequate area and quality to maintain survival and reproduction in spite of disturbances. Thus, the Monito gecko appears to have highly resilient population attributes ( e.g., habitat generalist, potential high adult survival rate) that allow at least some degree of disturbance within a harsh xeric environment.

For the Monito gecko, we determined that a foreseeable future of 20 to 30 years is reasonable. Based on the available information, making threat projections beyond this time frame increases speculation. For example, although rats could potentially reinvade Monito Island, the probability of rats reinvading is considered low since rats have not been detected after the eradication effort was completed in 1999. In addition, lifespan data for almost all of the Sphaerodactylus species is not available. One species from Martinique in the West Indies, Sphaerodactylus vicenti ronaldi, estimated longevity did not exceed 4 years (Leclair and Leclair 2011). Assuming the Monito gecko would have a similar lifespan, a foreseeable future of 20 to 30 years would allow for multiple generations and detection of any population changes. The Monito gecko has been listed since 1982, has persisted apparent mayor threats ( i.e. bombing effects, rat predation), and is currently well represented. Further, we do not anticipate significant impacts in the foreseeable future from climate change factors. Therefore, without no immediate risk of extinction, we have a baseline to continue assessing how the Monito gecko population may respond in the foreseeable future.

We carefully assessed the best scientific and commercial information available regarding the threats faced by the Monito gecko in developing the proposed rule and this final rule. The Service finds that the present or threatened destruction, modification, or curtailment of its habitat (factor A) is not a threat to the continued existence of the Monito gecko, and we do not expect it to be a threat in the future. We also conclude that overutilization (factor B) and disease (factor C) are not a threat to the Monito gecko. Natural predation by other native lizards may occur, but this activity is considered a low-magnitude threat because the Monito gecko has persisted despite potential predation and there is no indication that the magnitude of an undetermined natural predation pressure significantly affects the gecko's survival. No rats have been detected on Monito Island since August 1999. Therefore, we conclude that predation (factor C) is no longer a threat to the Monito gecko.

The species' apparent small population size (factor E), noted at the time of listing, may have been an artifact of bias as surveys were conducted under conditions when the species was not easily detectable. There are no known potential climate change effects ( i.e., sea level rise or changes in air temperature) (factor A) that negatively affect the Monito gecko. No other natural or manmade factors are considered threats (factor E). The Monito gecko and its habitat have been and will continue to be protected under Commonwealth laws and regulations (factor D), and these existing regulatory mechanisms are adequate to protect the Monito gecko now and in the future. The information indicates that this species is no longer at risk of extinction, nor is it likely to experience reemergence of threats and associated population declines in the foreseeable future. Based on the analysis above and after considering the best available scientific and commercial information, we conclude that the Monito gecko does not currently meet the Act's definition of either an endangered or threatened species throughout all or a significant portion of its range.

This final rule revises 50 CFR 17.11(h) to remove the Monito gecko from the Federal List of Endangered and Threatened Wildlife. The prohibitions and conservation measures provided by the Act would no longer apply to the Monito gecko. Federal agencies will no longer be required to consult with us under section 7 of the Act to ensure that any action authorized, funded, or carried out by them is not likely to jeopardize the gecko's continued existence. The prohibitions under section 9(a)(1) of the Act will no longer make it illegal for any person subject to the jurisdiction of the United States to import or export, transport in interstate or foreign commerce, or take, possess, sell, deliver, carry, transport, or ship Monito geckos. Finally, this rule will also remove the Federal regulations related to the Monito gecko listing: The critical habitat designation at 50 CFR 17.95(c).

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

Section 4(g) of the Act explicitly requires cooperation with the States (which includes Territories such as Puerto Rico) in development and implementation of PDM programs. However, we remain responsible for compliance with section 4(g) and, therefore, must remain actively engaged in all phases of PDM. We also seek active participation of other entities that are expected to assume responsibilities for the species' conservation after delisting. In April 2017, the PRDNER and the Service agreed to be cooperators in the PDM for the Monito gecko.

We have prepared a PDM Plan for the Monito gecko (USFWS 2017). The plan is designed to detect significant declines in the Monito gecko with reasonable certainty and precision, and detect possible new or reoccurring threats ( i.e., presence of rats). The plan:

(1) Summarizes the species' status at the time of delisting;

(2) Defines thresholds or triggers for potential monitoring outcomes and conclusions;

(3) Lays out frequency and duration of monitoring;

(4) Articulates monitoring methods including sampling considerations;

(5) Outlines data compilation and reporting procedures and responsibilities; and

(6) Proposes a PDM implementation schedule including timing and responsible parties.

It is our intent to work with our partners towards maintaining the recovered status of the Monito gecko.

We have determined that we do not need to prepare an Environmental Assessment or Environmental Impact Statement, as defined in the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), in connection with regulations adopted pursuant to section 4(a) of 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).

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 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. We have determined that no tribal lands are affected by this proposal.

A complete list of references cited is available on http://www.regulations.gov under Docket Number FWS-R4-ES-2017-0082.

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

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

This final rule implements regulatory amendments for Pacific halibut charter fishing in International Pacific Halibut Commission (IPHC) Regulatory Areas 2C (Southeast Alaska) and 3A (Southcentral Alaska). When Pacific halibut are simultaneously retained on a fishing vessel from both guided and unguided fishing, the daily bag limits, possession limits, size restrictions, and carcass retention requirements for guided fishing will apply to all Pacific halibut on board.

NMFS published the proposed rule for these regulatory amendments on February 12, 2019 (84 FR 3403). The comment period on the proposed rule ended on March 14, 2019. NMFS received seven comment letters on the proposed rule. From these letters, NMFS identified and considered seven unique, relevant comments. A summary of the comments and NMFS' responses are provided in the Comments and Responses section of this preamble.

A detailed review of this rule and the rationale for these regulations is provided in the preamble to the proposed rule (84 FR 3403, February 12, 2019). Electronic copies of the proposed rule and the Analysis may be obtained from www.regulations.gov or from the NMFS Alaska Region website at https:// www.fisheries.noaa.gov/region/alaska. All public comment letters submitted during the comment period may be obtained from www.regulations.gov.

The IPHC and NMFS manage fishing for Pacific halibut ( Hippoglossus stenolepis ) through regulations established under authority of the Northern Pacific Halibut Act of 1982 (Halibut Act). The IPHC adopts regulations governing the Pacific halibut fishery under the Convention between the United States and Canada for the Preservation of the Halibut Fishery of the Northern Pacific Ocean and Bering Sea (Convention), signed in Ottawa, Ontario, on March 2, 1953, as amended by the Protocol Amending the Convention (signed in Washington, DC on March 29, 1979). For the United States, regulations developed by the IPHC are subject to acceptance by the Secretary of State with concurrence from the Secretary of Commerce. After acceptance by the Secretary of State and concurrence by the Secretary of Commerce, NMFS publishes the IPHC regulations in the Federal Register as annual management measures pursuant to 50 CFR 300.62.

The Halibut Act, at 16 U.S.C. 773c(a) and (b), provides the Secretary of Commerce with general responsibility to carry out the Convention and the Halibut Act. In adopting regulations that may be necessary to carry out the purposes and objectives of the Convention and the Halibut Act, the Secretary of Commerce is directed to consult with the Secretary of the department in which the U.S. Coast Guard is operating, which is currently the Department of Homeland Security.

The Halibut Act, at section 16 U.S.C. 773c(c), also provides the North Pacific Fishery Management Council (Council) with authority to develop regulations, including limited access regulations, that are in addition to, and not in conflict with, approved IPHC regulations. Regulations developed by the Council may be implemented by NMFS only after approval by the Secretary of Commerce. The Council has exercised this authority in the development of subsistence halibut fishery management measures, the limited access program for charter operators in the charter halibut fishery, and the catch sharing plan and domestic management measures in waters in and off Alaska, codified at 50 CFR 300.61, 300.65, 300.66, and 300.67. The Council also developed the Individual Fishing Quota (IFQ) Program for the commercial halibut and sablefish fisheries, codified at 50 CFR part 679, under the authority of section 5 of the Halibut Act (16 U.S.C. 773c(c)) and section 303(b) of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1853(b)).

In addition to this summary, the preamble to the proposed rule and Section 2.7 of the Regulatory Impact Review (RIR) for this rule provide detail on charter halibut management programs that have been implemented in Areas 2C and 3A.

Throughout the proposed rule and this preamble, regulatory areas established by the IPHC are referred to as “IPHC Regulatory Areas” for the IFQ program regulations at 50 CFR part 679 and as “Commission regulatory areas” for the halibut management regulations at 50 CFR 300.61, 300.65, 300.66, and 300.67. This preamble uses the terms “Area 2C” and “Area 3A” to refer to IPHC Regulatory Areas 2C and 3A, respectively.

The harvest of halibut in Alaska occurs in three fisheries—the commercial, sport, and subsistence fisheries. The commercial halibut fishery is managed under the IFQ Program. The sport fishery includes guided and unguided anglers. Guided anglers are “charter vessel anglers” as defined at 50 CFR 300.61, and means persons, paying or non-paying, receiving sport fishing guide services for halibut. Throughout this preamble, the term “charter halibut fishery” is used to refer to the sport fishery prosecuted by charter operators who hold Charter Halibut Permits (CHPs) and offer sport fishing guide services for halibut. This preamble uses the terms “guided fishing” to refer to sport fishing by an angler who receives sport fishing guide services for halibut, and “guided angler” to an angler receiving those sport fishing guide services. This preamble uses the terms “unguided fishing” to refer to sport fishing by an angler who does not receive sport fishing guide services for halibut sport fishing, and “unguided angler” to an angler who does not receive those sport fishing guide services.

Essential background on the charter halibut fishery was presented in the proposed rule for this action, and in the Analysis. Among the topics described in the proposed rule is a summary of management of the charter halibut fishery and the development of the Charter Halibut Limited Access Program (CHLAP) that established a limited number of CHPs in the sport fishing sector in Areas 2C and 3A. The proposed rule also provides details on the Catch Sharing Plan (CSP) that annually allocates Pacific halibut harvests between the charter fishery and the commercial fisheries in Areas 2C and 3A. A component of the CSP describes the public process for determining annual management measures to limit charter harvest to the allocations in each management area. As part of this process, the Council develops recommendations that are forwarded to the IPHC.

The effect of the CSP and the annual charter fishing management measures result in distinct halibut sport fishing regulations in Areas 2C and 3A, depending upon whether anglers are guided (charter) or unguided. In general, to keep the charter fishery within its annual allocation, guided fishing regulations are more stringent than unguided fishing. Guided angling restrictions have become more pronounced in recent years, as halibut abundance has dropped and charter catch limits have been reduced.

Currently, unguided anglers are managed under a two-fish of any size daily bag limit in Alaska; however, since 2008, guided anglers in Area 2C have been managed under more restrictive limits. In Area 3A, guided anglers have been managed under more restrictive limits since 2014. For example, in 2019, guided anglers in Area 2C are limited to a daily bag limit of one fish and size limits that prohibit retention of halibut greater than 38 inches and less than 80 inches. In Area 3A in 2019, guided anglers may retain two halibut per day; however, one fish must be 28 inches or less, and guided anglers are allowed to retain a maximum of four fish in a calendar year. Additionally, guided anglers in Area 3A in 2019 are prohibited from retaining halibut on any Wednesday, and on five Tuesdays from July 16 through August 13. To enforce the halibut size limit restrictions in Areas 2C and 3A, if the fish are filleted on board the charter vessel, guided anglers are required to retain the carcasses of fish until all fillets are offloaded from Convention waters.

The maximum number of halibut an angler may possess at any one time in Areas 2C and 3A is two daily bag limits. Those possession limits correspond to the respective daily bag limits for guided or unguided anglers. For example, the 2019 daily bag limit for unguided anglers in Area 2C is two halibut, so the possession limit for unguided anglers is four halibut; however, for guided anglers in Area 2C in 2019, the daily bag limit is one halibut (within the size limit), so the possession limit for that sector is two halibut (within the size limit).

The CSP also authorizes limited annual leases of commercial IFQ for use in the charter fishery as guided angler fish (GAF). Charter vessel anglers can use GAF to retain halibut up to the limits provided for unguided halibut anglers.

This final rule changes regulations for the management of the charter halibut fishery in IPHC Regulatory Areas 2C and 3A. It implements a regulatory amendment that applies to situations in Areas 2C and 3A where Pacific halibut are caught and retained by guided and unguided anglers, and those halibut are on board a fishing vessel at the same time. In these situations, where halibut are comingled from both guided and unguided fishing, the bag limits, possession limits, size limits, and carcass retention requirements for guided fishing will apply to all halibut on board the vessel.

The preamble to the proposed rule provided a detailed description of the purpose and need for this final rule. A brief summary is provided here.

This final rule is intended to aid the enforcement and to ensure the proper accounting of halibut taken when sport fishing in Areas 2C and 3A. This final rule provides uniform halibut retention regulations, provides clearer regulatory standards for the public, reduces the amount of time needed by enforcement officers when boarding fishing vessels, and improves overall compliance with daily bag limits, possession limits, size limits, and carcass retention requirements.

When halibut are caught and retained by both guided and unguided anglers and those halibut are on the same fishing vessel, it presents enforcement challenges due to the different regulations for guided versus unguided anglers. The greatest challenge is for accountability under the bag and possession limits and halibut size restrictions. Under the current regulations, when halibut are caught and retained by guided and unguided anglers and those halibut are on the same fishing vessel, enforcement officers have no effective means to verify which angler harvested a particular fish, or whether that angler harvested the fish while fishing unguided or while being guided. It is important to note these enforcement challenges occur when the halibut from guided and unguided anglers is on board a fishing vessel in Convention waters. Therefore, this rule will not apply to Pacific halibut that is not on a fishing vessel. Section 2.3 of the RIR provides additional information on the history of this action.

This final rule adds a new paragraph at 50 CFR 300.65(d)(6). This paragraph applies to Areas 2C and 3A under circumstances when Pacific halibut are retained by both guided and unguided anglers, and those halibut are on the same fishing vessel.

The new paragraph at § 300.65(d)(6) requires all Pacific halibut on board a fishing vessel to be subject to the daily bag limit, the possession limit, size restrictions, and carcass retention requirements for guided anglers for that IPHC Area if any halibut caught and retained by a guided angler is on board that vessel. If sport fishing guide services are performed at any point during a charter fishing trip, then all anglers on board, for the full extent of the fishing trip, will be subject to the daily bag limit, possession limits, size restrictions, and carcass retention requirements for guided charter vessel anglers, as specified for the applicable IPHC regulatory area, and determined by the annual management measures recommended by the IPHC and NMFS and published by NMFS in the Federal Register .

Attention to both the IPHC and NMFS regulations is critical because there may be differences between the IPHC management measures and NMFS regulations. For example, in 2018, the IPHC adopted management measures for halibut size restrictions in Area 2C that were initially accepted by the Secretary of State and published by NMFS (83 FR 10390, March 9, 2018), but those regulations were eventually superseded by a subsequent action implemented by NMFS in an interim final rule (83 FR 12133, March 20, 2018).

This final rule does not modify regulations related to the management of GAF. Regulations for GAF are principally found in § 300.65(c)(5). These regulations allow transfers of commercial halibut IFQ to a charter operator, where the IFQ is translated to fish that individual anglers can use to increase their harvests up to the limits of unguided anglers, which is currently two fish of any size per day, with no annual limit. Under this rule, guided anglers will be able to continue to use GAF on charter vessel fishing trips. Regulations applicable to GAF permitting, transfer, use, and reporting requirements in § 300.65 will still apply.

NMFS did not make changes to the final rule from the proposed rule.

NMFS received seven comment letters on the proposed rule. Among the letters, NMFS identified and considered 7 unique, relevant comments, which are grouped, summarized, and responded to below. Three of the individual commenters identified themselves as either operators in the charter sector or representing charter fishing interests.

Comment 1: Several comments expressed support for the proposed regulations by recognizing the difficulty of adequately enforcing bag and possession limits when halibut from guided and unguided angling are comingled on a common fishing vessel.

Response: NMFS acknowledges the comments.

Comment 2: Some comments expressed support for the proposed rule by citing conservation concerns for halibut, and mentioned the more restrictive bag limits associated with guided halibut fishing.

Response: NMFS acknowledges that sport fishing bag limits are an important component in halibut conservation. NMFS also acknowledges the primary consideration of this final rule is the effective enforcement of those bag limits, which in turn supports the proper monitoring of catch necessary for conservation.

Comment 3: Halibut conservation and a decline in the resource are rationales to implement regulations that are different from the regulatory amendment suggested in the proposed rule. Halibut size limits that apply to guided fishing result in catch and release mortality by anglers who release many fish that fall outside of the allowable size restrictions. A simple solution is to establish the same regulations for both guided and unguided anglers, where all anglers are allowed one halibut of any size, per day.

Response: Establishing a one-fish daily bag limit for both guided and unguided anglers would require coordinated action by both the Council and IPHC and is outside of the scope of this rule. Catch and release mortality for sport caught halibut is estimated on an annual basis and is factored into the IPHC decisions on the combined commercial and charter catch limits in Areas 2C and 3A.

Comment 4: Some charter guides rent boats to clients so the clients can retain two halibut per day under the unguided fishing regulations. Regulations should allow only one halibut per day for all guests statewide, whether they fish from a charter vessel or from a lodge. This would be more equitable. Guides seem to always find a way to work around the rules. No person needs more than one halibut per day.

Response: Although this rule does not establish a bag limit of one halibut per day for all guests statewide, NMFS acknowledges the comment and points to the enforcement concerns that resulted in this final rule. NMFS also notes this rule applies to circumstances where halibut from both guided and unguided fishing are comingled on a fishing vessel, as defined by the Halibut Act, and operating in Convention waters.

Comment 5: The issue of the proposed regulation is an unquantified problem in a very minute segment of the sport fishery. The ratio of bad actors in guided fishing is likely the same as among unguided anglers; therefore, the burden of enforcement efforts should be on the agency to find ways to discover illicit activity while preserving the rights of the majority of people who act in compliance.

Response: NMFS agrees that the number of charter fishing vessels that offer mixed guided and unguided fishing is likely to be relatively small, compared to the total number of active charter vessels in any given year. NMFS agrees there is not currently information that can precisely identify the number of charter fishing vessels and the number of charter fishing trips where mixed guided and unguided halibut fishing occurs. However, the Council expressed its intent, and NMFS agrees, that the enforcement concerns are significant for those operations where mixed guided and unguided halibut fishing occurs, and that this issue warrants the regulatory amendment implemented by this final rule. NMFS also notes the enforcement issue, if left unaddressed, could continue to grow as more charter operations decide to offer the option of mixed guided and unguided fishing on their vessels.

NMFS also notes this final rule does not prevent charter fishing vessels from continuing to offer mixed guided and unguided fishing. As mentioned in the proposed rule, public testimony to the Council suggests that—in addition to the bag, possession, and size limits addressed by this rule—pricing, convenience, and the personal preferences of the client anglers can also be reasons for sport fishing businesses to offer unguided fishing along with guided fishing.

Comment 6: GAF is still allowed under the proposed regulations; therefore, the number and size of halibut that are onboard the fishing vessel may already exceed the guided fishing limits, although GAF must be accounted for on GAF permits. A similar requirement could be implemented for unguided fish, rather than alter size and bag limits.

Response: NMFS acknowledges that the regulatory amendment implemented under this rule allows the continued and unchanged use of GAF. When halibut regulations place size or harvest restrictions on anglers, qualified charter halibut permit holders may offer GAF to their clients as a means to retain halibut of any size, and up to the limits allowed for unguided anglers, which is currently two fish of any size per day, with four fish in possession. Under this final rule, when fishing vessels employ a mix of guided and unguided fishing, all anglers will be subject to the guided angler harvest restrictions; therefore, all anglers on the vessel will be eligible to use GAF.

As stated in the comment, regulations require that GAF harvests must be recorded on a GAF permit log. GAF must also be physically identified by removing the tips of the upper and lower lobes of the halibut tail fin. A marking and logging system similar to GAF that would be used to account for halibut retained by unguided anglers was not an alternative that was analyzed or recommended by the Council for this action.

Comment 7: Typical enforcement happens by boarding vessels engaged in fishing or by conducting dockside interviews at the termination of a trip. Nothing prohibits enforcement officers from boarding guided or unguided vessels associated with a mother ship during fishing activity or upon return to the mother vessel to determine compliance with existing regulation. There is no current or proposed requirement that anglers remain on board a mother vessel with their processed catch, so investigation of preserved fish after transfer from other fishing vessels, or fish harvested and processed on the same vessel, becomes an independent issue.

Response: NMFS acknowledges the comment, and agrees that enforcement boardings and interviews will continue on all fishing vessels, whether those vessels fish independently or whether they are associated with a mothership. NMFS also notes the primary enforcement issue that is addressed by this final rule, which is the proper determination of regulatory compliance after halibut are brought back to a common fishing vessel ( i.e., a mothership), and those halibut come from a mix of guided and unguided fishing. Under these circumstances, enforcement officers currently have no effective means to properly account for the retained catch. The Council indicated, and NMFS agrees, that uniform regulations in these situations will enhance compliance and eliminate confusion among both anglers and enforcement officers.

Regulations governing the U.S. fisheries for Pacific halibut are developed by the IPHC, the Pacific Fishery Management Council, the North Pacific Fishery Management Council, and the Secretary of Commerce. Section 5 of the Halibut Act (16 U.S.C. 773c) allows the regional fishery management council having authority for a particular geographical area to develop regulations governing fishing for halibut in U.S. Convention waters as long as those regulations do not conflict with IPHC regulations. The Halibut Act at 16 U.S.C. 773c(a) and (b) provides the Secretary of Commerce with the general responsibility to carry out the Convention with the authority to, in consultation with the Secretary of the department in which the U.S. Coast Guard is operating, adopt such regulations as may be necessary to carry out the purposes and objectives of the Convention and the Halibut Act. This final rule is consistent with the Halibut Act and other applicable laws. This final rule is also consistent with the Secretary of Commerce's authority under the Halibut Act to implement management measures for the halibut fishery.

This final rule has been determined to be not significant for purposes of Executive Order 12866.

A Regulatory Impact Review was prepared to assess the costs and benefits of available regulatory alternatives. A copy of this final analysis is available from NMFS (see ADDRESSES ). The Council recommended the regulatory revisions in this final rule based on those measures that maximized net benefits to the Nation. Specific aspects of the economic analysis related to the impact of this final rule on small entities are discussed below in the Final Regulatory Flexibility Analysis section.

This FRFA incorporates the initial regulatory flexibility analysis (IRFA), a summary of the significant issues raised by the public comments in response to the IRFA, if any, and NMFS' responses to those comments, and a summary of the analyses completed to support this action.

Section 604 of the Regulatory Flexibility Act (RFA) (5 U.S.C. 604) requires that, when an agency promulgates a final rule under section 553 of Title 5 of the U.S. Code, after being required by that section or any other law to publish a general notice of proposed rulemaking, the agency shall prepare a FRFA. Section 604 describes the required contents of a FRFA: (1) A statement of the need for and objectives of the rule; (2) a statement of the significant issues raised by the public comments in response to the IRFA, a statement of the assessment of the agency of such issues, and a statement of any changes made to the proposed rule as a result of such comments; (3) the response of the agency to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA) in response to the proposed rule, and a detailed statement of any change made to the proposed rule in the final rule as a result of the comments; (4) a description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available; (5) a description of the projected reporting, recordkeeping, and other compliance requirements of the rule, including an estimate of the classes of small entities that will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; and (6) a description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in this final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.

A description of this final rule, along with the need for and objectives of the rule, are contained in the preamble to this final rule and the preamble to the proposed rule (84 FR 3403, February 12, 2019), and are not repeated here.

NMFS published the proposed rule on February 12, 2019 (84 FR 3403). An IRFA was prepared and included in the Classification section of the preamble to the proposed rule. The comment period on the proposed rule ended on March 14, 2019. One of the comments indirectly referenced the IRFA and has been addressed in the Comments and Responses section of the preamble (Comment 5; number of entities affected by this rule). The Chief Counsel for Advocacy of the SBA did not file any comments on the proposed rule.

This final rule directly regulates (1) sport fishing businesses that currently offer, or would offer, both guided and unguided halibut fishing opportunities, and the sport fishing guides that work for those businesses (“charter operations”); and (2) unguided anglers who retain halibut on board vessels at the same time as guided anglers who have also retained halibut.

NMFS does not collect information on the number of entities that offer mixed guided and unguided halibut fishing, and there appears to be no systematic means to determine an accurate number of those entities. An informal survey by enforcement officers, combined with testimony and comments from the public, indicates the practice of mixing guided and unguided fishing primarily occurs on larger charter vessels that provide multi-day fishing trips. This analysis indicates that approximately 30 fishing vessel businesses in Area 2C and 14 similar businesses in Area 3A currently offer multi-day fishing trips for their clients. This should be considered an upper-bound estimate of the number of businesses directly regulated by this action at this time because the number of those operations that offer mixed guided and unguided fishing is unknown. Public comment also indicates that on relatively rare occasions, anglers will mix guided and unguided fishing when they are based out of a shoreside lodge or facility that provides rental boats.

For Regulatory Flexibility Act (RFA) purposes only, the SBA has established a small business size standard for businesses, including their affiliates, whose primary industry is scenic and sightseeing transportation on water, or all other amusement and recreation (NAICS codes 487210, and 713990, respectively).

On July 18, 2019, the Small Business Administration (SBA) issued an interim final rule (84 FR 34261) effective August 19, 2019, that adjusted the monetary-based industry size standards ( i.e., receipts- and assets-based) for inflation for many industries. For fisheries for-hire businesses and marinas, the rule changes the small business size standard from $7.5 million in annual gross receipts to $8 million. See 84 FR at 34273 (adjusting NAICS 487990 (Scenic and Sightseeing Transportation, Other) and 713930 (Marinas)).

Pursuant to the Regulatory Flexibility Act, and prior to SBA's July 18, 2019 interim final rule, a final regulatory flexibility analysis was developed for this action using SBA's former size standards. NMFS has reviewed the analyses prepared for this action in light of the new size standards. Under the former SBA size standards, all entities subject to this action were considered small entities, and they all would continue to be considered small under the new standards.

NMFS has determined that the new size standards do not affect analyses prepared for this action. It is unlikely that the largest of the affected charter vessel operations would be considered large entities under either the former or current SBA standards; however, that cannot be confirmed because NMFS does not have or collect economic data on lodges or charter vessels necessary to definitively determine total annual receipts. Thus, all charter vessel operations are considered small entities, based on SBA criteria, because NMFS cannot confirm if any entities have annual gross revenues greater than either the former $7.5 million or current $8.0 million standards.

Community quota entities (CQEs) may apply for and receive community CHPs and some of those charter operations could potentially offer mixed guided and unguided halibut fishing; therefore, this final rule may directly regulate CQEs, and the CQEs are non-profit entities that represent small, remote communities in Areas 2C and 3A. There are 20 communities in Area 2C and 14 in Area 3A eligible to receive community CHPs. Of these 34 communities, 20 hold community CHPs. Again, the number of these CHP holders who offer, or would offer, mixed guided and unguided fishing is unknown.

This final rule applies more restrictive halibut bag and possession limits on clients that take multi-day charters with mixed guided and unguided halibut fishing activity. These individuals are not considered directly regulated small entities under the RFA. However, this action will also apply these more restrictive catch and possession limits on vessel crew and guides who choose to fish for halibut in any time off they may have during a guided trip. It is possible that these crew and guides may operate as subcontractors to the primary vessel and, as such, may be defined as small entities. However, the applicability of the more restrictive limits to any of these potential small entities is as an indirect consequence of their being aboard the vessel on a mixed guided and unguided trip. Thus, they are not considered to be directly regulated small entities for RFA purposes.

Based on this analysis, NMFS has determined that there are directly regulated small entities affected by this action. The RIR notes that the action could increase costs for multi-day vessels that continue to offer both guided and unguided fishing due to transporting halibut to shore to prevent mixing. However, the analysts were unable to determine if these costs would occur or, if they did, the magnitude of these costs. NMFS indicated in the proposed rule that it may consider certifying that this action will not have a significant economic impact on a substantial number of small entities prior to publication of the final rule. However, due to the assumptions necessary to establish the factual basis for certification and the lack of information available to conduct this analysis, NMFS decided to prepare a FRFA for this action.

This final rule does not change the recordkeeping and reporting requirements for charter halibut fishing or unguided halibut fishing in the affected Areas 2C and 3A. In terms of other compliance requirements, the final rule applies the daily bag limits, possession limits, size restrictions, and carcass retention requirements for guided fishing to all Pacific halibut on board a fishing vessel when Pacific halibut caught and retained by both guided anglers and unguided anglers are on the same vessel.

NMFS and the Council considered three alternatives for this rule. Alternative 1 was the no action alternative. This alternative would have continued to maintain different daily bag limits, possession limits, size restrictions, and carcass retention requirements for guided anglers and unguided anglers even if halibut caught and retained by both guided and unguided anglers are on the same fishing vessel simultaneously. The benefit of status quo is the flexibility and business advantages for operators seeking to accommodate the desires of a broad range of clients, and their anglers can choose guided fishing, unguided fishing, or alternating between guided and unguided fishing at different times.

The concerns about status quo are expressed in the Council's purpose and need statement and in the RIR analysis. In Areas 2C or 3A, guided anglers are frequently subject to greater harvest restrictions than unguided anglers. When halibut from guided and unguided fishing are commingled on a vessel in these management areas, it is difficult for enforcement officers to determine whether the halibut were caught by guided or unguided anglers. When vessels are boarded by enforcement officers, establishing each person's catch and whether that person was guided or unguided can become a lengthy and complicated process for both officers and charter operators.

Alternative 2 was also considered by NMFS and the Council. It would have prevented the commingling of halibut catches from guided and unguided anglers on fishing vessels by prohibiting the possession of halibut retained by guided anglers with halibut retained by unguided anglers on the same fishing vessel simultaneously. The primary advantage of this alternative is that it would have maximized compliance of the regulations and likely reduced the duration of at-sea boardings by enforcement officers.

The RIR describes the disadvantages of Alternative 2, which are primarily the reduced flexibility and potential lost revenue for multi-day fishing vessels that currently provide, or would seek to provide, the option of mixed guided and unguided fishing. If charter operations wanted to switch from guided to unguided fishing, the vessels would need to assume the time and cost of returning to port, offloading the fish, and then beginning a new trip to prevent comingling of halibut.

Alternative 3 is the adopted alternative and is also described in detail in the RIR. Alternative 3 is intended to balance the enforcement concerns that result from commingling of halibut from guided and unguided fishing with an allowance for charter operations to maintain the flexibility of offering a mix of guided and unguided fishing, as they do now. Moreover, Alternative 3 allows other operations to assume the practice of offering both guided and unguided fishing in the future. The Council's enforcement concerns are addressed by establishing uniform bag limits, possession limits, size restrictions, and carcass retention requirements for all halibut retained by anglers on a fishing vessel, irrespective of whether the angler was guided or unguided.

Under Alternative 3, some of the requirements for guided anglers would not be imposed on unguided anglers, largely because the proposed alignment of bag and possession limits, size restrictions, and carcass retention requirements effectively serve to mitigate the compliance risks associated with the commingling of halibut on a fishing vessel that were caught and retained by both guided and unguided anglers. For example, this final rule will not require unguided anglers to individually record their daily catch and accrue it toward guided angler annual limits, which is currently a maximum of four fish in Area 3A. Additionally, day of the week closures for guided anglers, which is a restriction to catching and retaining Pacific halibut on specific days and is currently used in Area 3A, will not apply to unguided anglers.

The RIR examines the potential negative effects of this final rule, which largely relates to reduced harvest limits for unguided anglers who have their halibut on the same fishing vessel as guided anglers. One of the advantages of fishing unguided is that anglers are allowed to keep two fish of any size per day and keep a possession limit of four fish. Relative to the status quo, it is possible that this final rule which would reduce the number and size of halibut that can be retained by unguided anglers in some situations, could also reduce the incentive to purchase charter halibut trips.

As noted above, the entities directly regulated under this final rule are assumed to be small, by the SBA definition. Overall, however, this action is likely to have a limited effect on net benefits to the Nation. The majority of Area 2C and 3A halibut charter operations, which includes business owners, guides and crew members, would not be subject to significant negative economic impacts by this final rule. Thus, NMFS is not aware of any alternatives, in addition to the alternatives considered, that would more effectively meet the RFA criteria, the objectives of the Halibut Act and other applicable statutes at a lower economic cost to directly regulated small entities.

This final rule contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA),which have been approved by the Office of Management and Budget (OMB) under OMB control number 0648-0575 (Alaska Pacific Halibut Fisheries: Charter Recordkeeping). Public reporting burden per response is estimated to average 4 minutes for the ADF&G Saltwater Sport Fishing Charter Trip Logbook, 5 minutes for the GAF Landing Report, and 2 minutes for the GAF Permit Log. The response time includes time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

The ADF&G Saltwater Sport Fishing Charter Trip Logbook, GAF Electronic Landing Report, and GAF Permit Log are mentioned in this final rule. Each of these are reporting requirements specified by NMFS regulations. The requirements apply only to the harvest accounting of charter vessel anglers by charter vessel guides. Under this final rule, the harvests of unguided charter vessel anglers will not be subject to these requirements; therefore, this rulemaking imposes no additional burden or cost on the regulated community.

Send comments regarding this burden estimate, or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see ADDRESSES ), and by email to OIRA_Submission@omb.eop.gov, or fax to (202) 395-5806.

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number. All currently approved NOAA collections of information may be viewed at: https://www.cio.noaa.gov/services_programs/prasubs.html.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a final regulatory flexibility analysis, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. The preambles to the proposed rule and this final rule serve as the small entity compliance guide. Copies of the proposed rule and this final rule are available from the NMFS website at https://fisheries.noaa.gov/region/alaska.

For the reasons set out in the preamble, NMFS amends 50 CFR part 300 as follows:

Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq. ) and the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq. ) governing the harvest of BFT by persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. Section 635.27 subdivides the U.S. BFT quota recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT) among the various domestic fishing categories, per the allocations established in the 2006 Consolidated Highly Migratory Species Fishery Management Plan (2006 Consolidated HMS FMP) (71 FR 58058, October 2, 2006) and amendments. NMFS is required under ATCA and the Magnuson-Stevens Act to provide U.S. fishing vessels with a reasonable opportunity to harvest the ICCAT-recommended quota.

The current baseline General and Reserve category quotas are 555.7 mt and 29.5 mt, respectively. See § 635.27(a). Each of the General category time periods (January, June through August, September, October through November, and December) is allocated a “subquota” or portion of the annual General category quota. The baseline subquotas for each time period are as follows: 29.5 mt for January; 277.9 mt for June through August; 147.3 mt for September; 72.2 mt for October through November; and 28.9 mt for December. Any unused General category quota rolls forward within the fishing year, which coincides with the calendar year, from one time period to the next, and is available for use in subsequent time periods. To date for 2019, NMFS has taken six actions that resulted in adjustments to the Reserve category, leaving 165.3 mt of quota currently available (84 FR 3724, February 13, 2019; 84 FR 6701, February 28, 2019; 84 FR 35340, July 23, 2019; 84 FR 47440, September 10, 2019; and 84 FR 48566, September 16, 2019).

Under § 635.27(a)(9), NMFS has the authority to transfer quota among fishing categories or subcategories, after considering regulatory determination criteria provided under § 635.27(a)(8). NMFS has considered all of the relevant determination criteria and their applicability to this inseason quota transfer. These considerations include, but are not limited to, the following:

Regarding the usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock (§ 635.27(a)(8)(i)), biological samples collected from BFT landed by General category fishermen and provided by bluefin tuna dealers continue to provide valuable data for ongoing scientific studies of bluefin tuna age and growth, migration, and reproductive status. Additional opportunity to land bluefin tuna in the General category would support the continued collection of a broad range of data for these studies and for stock monitoring purposes.

NMFS also considered the catches of the General category quota to date and the likelihood of closure of that segment of the fishery if no adjustment is made (§ 635.27(a)(8)(ii) and (ix)). NMFS anticipates that the current October through November subquota of 72.2 mt could be reached in a few days, given the high daily landings rates that were occurring when the September fishery closed and that commercial-sized bluefin tuna remain available in the areas where General category permitted vessels operate at this time of year. Without a quota transfer, NMFS would have to close the General category fishery for the remainder of the October through November subquota period very early, while unused quota remains in the Reserve category. Transferring 100 mt of quota from the Reserve category would result in 172.2 mt being available for the October through November 2019 subquota period, thus effectively providing additional opportunities to harvest the U.S. bluefin tuna quota while avoiding exceeding it.

Regarding the projected ability of the vessels fishing under the particular category quota (here, the General category) to harvest the additional amount of BFT before the end of the fishing year (§ 635.27(a)(8)(iii)), NMFS anticipates that all of the 100 mt of quota will be used by November 30, based on current figures and the amount of quota being transferred, but this is also subject to weather conditions and bluefin tuna availability. In the unlikely event that any of this quota is unused by November 30, such quota will roll forward to the next subperiod within the calendar year ( i.e., the December period), and NMFS anticipates that it would be used before the end of the fishing year.

NMFS also considered the estimated amounts by which quotas for other gear categories of the fishery might be exceeded (§ 635.27(a)(8)(iv)) and the ability to account for all 2019 landings and dead discards. In the last several years, total U.S. BFT landings have been below the available U.S. quota such that the United States has carried forward the maximum amount of underharvest allowed by ICCAT from one year to the next. NMFS will need to account for 2019 landings and dead discards within the adjusted U.S. quota, consistent with ICCAT recommendations, and anticipates having sufficient quota to do that, even with the 100 mt transfer to the General category for the October through November fishery. NMFS anticipates that General category participants in all areas and time periods will have opportunities to harvest the General category quota in 2019, through active inseason management such as the timing of quota transfers, as practicable. Thus, this quota transfer would allow fishermen to take advantage of the availability of fish on the fishing grounds to the extent consistent with the available amount of transferrable quota and other management objectives, while avoiding quota exceedance.

NMFS also considered the effects of the adjustment on the BFT stock and the effects of the transfer on accomplishing the objectives of the FMP (§ 635.27(a)(8)(v) and (vi)). This transfer would be consistent with the current quotas, which were established and analyzed in the 2018 BFT quota final rule (83 FR 51391, October 11, 2018), and with objectives of the 2006 Consolidated HMS FMP and amendments and is not expected to negatively impact stock health or to affect the stock in ways not already analyzed in those documents. Another principal consideration is the objective of providing opportunities to harvest the full annual U.S. BFT quota without exceeding it based on the goals of the 2006 Consolidated HMS FMP and amendments, including to achieve optimum yield on a continuing basis and to optimize the ability of all permit categories to harvest their full BFT quota allocations (related to § 635.27(a)(8)(x)). Specific to the General category, this includes providing opportunity equitably across all time periods.

Based on the considerations above, NMFS is transferring 100 mt of the available 165.3 mt of Reserve category quota to the General category for the October through November 2019 fishery, resulting in a subquota of 172.2 mt for the October through November 2019 fishery and 65.3 mt in the Reserve category.

NMFS will continue to monitor the BFT fishery closely. Dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. Late reporting by dealers compromises NMFS' ability to timely implement actions such as quota and retention limit adjustment, as well as closures, and may result in enforcement actions. Additionally, and separate from the dealer reporting requirement, General and HMS Charter/Headboat category vessel owners are required to report the catch of all BFT retained or discarded dead within 24 hours of the landing(s) or end of each trip, by accessing hmspermits.noaa.gov, using the HMS Catch Reporting app, or calling (888) 872-8862 (Monday through Friday from 8 a.m. until 4:30 p.m.).

Depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional action ( e.g., quota adjustment, daily retention limit adjustment, or closure) is necessary to ensure available subquotas are not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas. If needed, subsequent adjustments will be published in the Federal Register . In addition, fishermen may call the Atlantic Tunas Information Line at (978) 281-9260, or access hmspermits.noaa.gov, for updates on quota monitoring and inseason adjustments.

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

The regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason quota transfers to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Affording prior notice and opportunity for public comment to implement the quota transfer is impracticable and contrary to the public interest as such a delay would likely result in exceedance of the General category October through November fishery subquota or earlier closure of the fishery while fish are available on the fishing grounds. Subquota exceedance may result in the need to reduce quota for the General category later in the year and thus could affect later fishing opportunities. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For all of the above reasons, there also is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.

This action is being taken under §§ 635.27(a)(9) and 635.28(a)(1), and is exempt from review under Executive Order 12866.