The EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0082, dated April 11, 2018 (EASA AD 2018-0082) (also referred to as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for Leonardo S.p.a. Model AW189 helicopters, if equipped with bubble windows kit part number 8G5620F00111.

This AD was prompted by a report of a bubble window departing from the helicopter during flight. The FAA is issuing this AD to address degradation of the installation of the bubble windows, which could cause loss of a bubble window during flight, possibly resulting in damage to the helicopter and injury to persons on the ground. See the MCAI for additional background information.

EASA AD 2018-0082 specifies procedures for, among other actions, modifying the left-hand and right-hand bubble windows with an improved bubble window kit. This material 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.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, the FAA has been notified of the unsafe condition described in the MCAI referenced above. The FAA is issuing this AD after evaluating all pertinent information and determining that the unsafe condition exists and is likely to exist or develop on other products of the same type design.

This AD requires accomplishing the actions specified in EASA AD 2018-0082, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this AD and except as discussed under “Differences Between this AD and the MCAI.”

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA initially worked with Airbus and EASA to develop a process to use certain EASA ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has since coordinated with other manufacturers and civil aviation authorities (CAAs) to use this process. As a result, EASA AD 2018-0082 is incorporated by reference in this final rule. This AD, therefore, requires compliance with EASA AD 2018-0082 in its entirety, through that incorporation, except for any differences identified as exceptions in the regulatory text of this AD. Using common terms that are the same as the heading of a particular section in the EASA AD does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in the EASA AD. Service information specified in EASA AD 2018-0082 that is required for compliance with EASA AD 2018-0082 is available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-0446.

The requirements specified in paragraphs (1), (2), (3) and (5) of EASA AD 2018-0082 do not apply to this AD.

Section 553(b)(3)(B) of the Administrative Procedure Act (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.

There are currently no domestic operators of these products. Therefore, the FAA finds that notice and opportunity for prior public comment are unnecessary and that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days.

The FAA invites you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-0446; Project Identifier 2018-SW-029-AD” at the beginning of your comments. The most helpful comments reference a specific portion of the AD, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this AD because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this AD.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Andrea Jimenez, Aerospace Engineer, Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: 516-228-7330; fax: 516-794-5531; email: 9-avs-nyaco-cos@faa.gov. Any commentary that the FAA receives that is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The requirements of the 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.

Currently, there are no affected U.S.-registered helicopters. If an affected helicopter is imported and placed on the U.S. Register in the future, the FAA provides the following cost estimates to comply with this AD:

According to the manufacturer, some or all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. The FAA does not control warranty coverage for affected individuals. As a result, the FAA has included all known costs in the cost estimate.

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

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

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

For the reasons discussed above, I certify this regulation:

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

(2) Will not affect intrastate aviation in Alaska.

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

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 airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the Class E airspace at Missoula International Airport, Missoula, MT, to ensure the safety and management of instrument flight rules (IFR) operations at the airport.

The FAA published a notice of proposed rulemaking in the Federal Register (86 FR 18488; April 9, 2021) for Docket No. FAA-2021-0208 to modify the Class E airspace at Missoula International Airport, Missoula, MT. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. One comment was received. The commenter suggested that the Class E5 airspace boundaries should be expanded to encompass all of the Class G airspace, extending upward from 1,200 feet above the surface, near the airport. The FAA does not agree. Title 49 of the US Code provides the FAA with its legal authority to manage the NAS. It also provides that citizens of the United States have a public right of transit through navigable airspace. Minimizing the volume of regulated airspace ensures the FAA is being consistent to its legislated responsibilities. Class E5 airspace is designed to contain IFR operations transitioning to or from the terminal and en route environments. Expanding the airspace boundaries for the sole purpose of reducing areas of Class G airspace would not be appropriate.

Class E5 airspace designations are published in paragraph 6005 of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to 14 CFR part 71 modifies the Class E airspace, extending upward from 1,200 feet above the surface, at Missoula International Airport, Missoula, MT. This airspace is designed to contain IFR aircraft transitioning to/from the terminal and en route environments. This action proposes to increase the airspace's radius of the airport from 35 miles to 46 miles. The 46-mile radius will properly contain IFR aircraft transitioning to/from the airport.

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

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, is non-controversial, and unlikely to result in adverse or negative comments. 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 will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant the preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The Entity List (supplement no. 4 to part 744 of the EAR) identifies entities for which there is reasonable cause to believe, based on specific and articulable facts, that the entities have been involved, are involved, or pose a significant risk of being or becoming involved in activities contrary to the national security or foreign policy interests of the United States. The EAR (15 CFR parts 730-774) impose additional license requirements on, and limit the availability of most license exceptions for, exports, reexports, and transfers (in-country) to listed entities. The license review policy for each listed entity is identified in the “License Review Policy” column on the Entity List, and the impact on the availability of license exceptions is described in the relevant Federal Register document adding entities to the Entity List. BIS places entities on the Entity List pursuant to part 744 (Control Policy: End-User and End-Use Based) and part 746 (Embargoes and Other Special Controls) of the EAR.

The ERC, composed of representatives of the Departments of Commerce (Chair), State, Defense, Energy and, where appropriate, the Treasury, makes all decisions regarding additions to, removals from, or other modifications to the Entity List and the Military End User (MEU) List. The ERC makes all decisions to add an entry to the Entity List and MEU List by majority vote and all decisions to remove or modify an entry by unanimous vote.

This rule implements a decision of the ERC to remove Satori Corporation, an entity located in France and the UAE, from the Entity List on the basis of a removal request. The entries for Satori Corporation under the destinations of France and the UAE were added to the Entity List on December 22, 2020 (85 FR 83420, December 22, 2020). The ERC decided to remove this one entity with two entries based on information BIS received pursuant to § 744.16 of the EAR and the review the ERC conducted in accordance with procedures described in supplement no. 5 to part 744 of the EAR.

This final rule implements the decision to remove the following one entity under two entries, located in France and the UAE, from the Entity List:

• Satori Corporation.

• Satori Corporation.

On August 13, 2018, the President signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which included the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4801-4852). ECRA provides the legal basis for BIS's principal authorities and serves as the authority under which BIS issues this rule.

1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has been designated to be not significant for purposes of Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond to or be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves collections previously approved by OMB under control number 0694-0088, Simplified Network Application Processing System, which includes, among other things, license applications, and carries a burden estimate of 29.6 minutes for a manual or electronic submission. Total burden hours associated with the PRA and OMB control number 0694-0088 are not expected to increase as a result of this rule.

3. This rule does not contain policies with federalism implications as that term is defined in Executive Order 13132.

4. Pursuant to section 1762 of ECRA (50 U.S.C. 4821), this action is exempt from the Administrative Procedure Act (5 U.S.C. 553) requirements for notice of proposed rulemaking, opportunity for public participation, and delay in effective date.

5. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., are not applicable. Accordingly, no regulatory flexibility analysis is required and none has been prepared.

Accordingly, part 744 of the Export Administration Regulations (15 CFR parts 730-774) is amended as follows:

The Convention on Cultural Property Implementation Act, Public Law 97-446, 19 U.S.C. 2601 et seq. (hereinafter, “the Cultural Property Implementation Act”) implements the 1970 United Nations Educational, Scientific and Cultural Organization (UNESCO) Convention on the Means of Prohibiting and Preventing the Illicit Import, Export and Transfer of Ownership of Cultural Property (hereinafter, “the Convention” (823 U.N.T.S. 231 (1972)). Pursuant to the Cultural Property Implementation Act, the United States entered into a bilateral agreement with the Republic of Turkey (Turkey) to impose import restrictions on certain archaeological and ethnological material from Turkey. This rule announces that the United States is now imposing import restrictions on certain archaeological and ethnological material from Turkey.

Under 19 U.S.C. 2602(a)(1), the United States must make certain determinations before entering into an agreement to impose import restrictions under 19 U.S.C. 2602(a)(2). On March 27, 2020, the Assistant Secretary for Educational and Cultural Affairs, United States Department of State, after consultation with and recommendation by the Cultural Property Advisory Committee, made the determinations required under the statute with respect to certain archaeological and ethnological material originating in Turkey that is described in the Designated List set forth below in this document.

These determinations include the following: (1) That the cultural patrimony of Turkey is in jeopardy from the pillage of archaeological material representing Turkey's cultural heritage dating from approximately 1.2 million years ago to A.D. 1770, and ethnological material dating from approximately the 1st century A.D. to A.D. 1923; (2) that the Turkish government has taken measures consistent with the Convention to protect its cultural patrimony (19 U.S.C. 2602(a)(1)(B)); (3) that import restrictions imposed by the United States would be of substantial benefit in deterring a serious situation of pillage and remedies less drastic are not available (19 U.S.C. 2602(a)(1)(C)); and (4) that the application of import restrictions as set forth in this final rule is consistent with the general interests of the international community in the interchange of cultural property among nations for scientific, cultural, and educational purposes (19 U.S.C. 2602(a)(1)(D)). The Assistant Secretary also found that the material described in the determinations meets the statutory definition of “archaeological or ethnological material of the State Party” (19 U.S.C. 2601(2)).

On January 19, 2021, the United States and Turkey signed a bilateral agreement, “Memorandum of Understanding between the Government of the United States of America and the Government of the Republic of Turkey Concerning the Imposition of Import Restrictions on Categories of Archaeological and Ethnological Material of Turkey” (“the Agreement”), pursuant to the provisions of 19 U.S.C. 2602(a)(2). The Agreement entered into force on March 24, 2021, upon the exchange of diplomatic notes, and enables the promulgation of import restrictions on categories of archaeological material, ranging in date from approximately 1.2 million years ago to A.D. 1770, and ethnological material, ranging in date from the 1st century A.D. to A.D. 1923, representing Turkey's cultural heritage. A list of the categories of archaeological and ethnological material subject to the import restrictions is set forth later in this document.

In accordance with the Agreement, importation of material designated below is subject to the restrictions of 19 U.S.C. 2606 and § 12.104g(a) of title 19 of the Code of Federal Regulations (19 CFR 12.104g(a)) and will be restricted from entry into the United States unless the conditions set forth in 19 U.S.C. 2606 and § 12.104c of the CBP Regulations (19 CFR 12.104c) are met. CBP is amending § 12.104g(a) of the CBP Regulations (19 CFR 12.104g(a)) to indicate that these import restrictions have been imposed.

Import restrictions listed as 19 CFR 12.104g(a) are effective for no more than five years beginning on the date on which the Agreement enters into force with respect to the United States. This period may be extended for additional periods of not more than five years if it is determined that the factors which justified the Agreement still pertain and no cause for suspension of the Agreement exists. The import restrictions will expire on March 24, 2026, unless extended.

The Agreement between the United States and Turkey includes, but is not limited to, the categories of objects described in the Designated List set forth below. Importation of material on this list is restricted unless the material is accompanied by documentation certifying that the material left Turkey legally and not in violation of the export laws of Turkey.

The Designated List includes archaeological material from Turkey ranging in date from approximately 1.2 million years ago to A.D. 1770, and ethnological material from Turkey from the 1st century A.D. to the end of the Ottoman Empire with the foundation of the Republic of Turkey in A.D. 1923.

Archaeological material covered by the Agreement includes material from Turkey ranging in date from approximately 1,200,000 B.C. to A.D. 1770. Examples of archaeological material covered by the agreement include, but are not limited to, the following objects:

A. Stone

1. Sculpture

a. Architectural Elements—Primarily in basalt, limestone, and marble; including blocks from walls, floors, and ceilings; acroterion, antefix, architrave, columns, capitals, bases, lintels, jambs, friezes, pediments, tympanum, metopes, and pilasters; doors, door frames, and window fittings; caryatids, columns, altars, prayer niches, mihrab, screens, wellheads, fountains, mosaics, and tiles. This category also includes relief and inlay sculpture that may have been part of a building, such as friezes of sculpted stone figures set into inlaid stone or bitumen backgrounds. May be plain, molded, carved, or inscribed. Decorative motifs may be incised or in high relief. Approximate date: 10th millennium B.C. to the 18th century A.D.

b. Monuments and Stelae—Types include triumphal arches and columns, obelisk, herms, and stone blocks. This category also includes votive and funerary stelae with or without relief sculpture and/or inscriptions, usually in limestone, basalt, and marble. Common subject matter also includes human and animal figures, floral motifs, and geometric designs. Approximate date: 10th millennium B.C. to the 18th century A.D.

c. Sarcophagi and Ossuaries—In marble and limestone. The sides and lids of sarcophagi and ossuaries ( osthoteks ) may have relief sculptures of human and animal figures, inscriptions, monograms, and floral and geometric decoration. Approximate date: 10th millennium B.C. to the 18th century A.D.

d. Large Statuary—Primarily in basalt and marble, some examples in limestone, steatite (soapstone), and other types of stone. Subject matter includes human, animal, and mythological figures, icons, busts, models, molds, and groups of figures in the round, as well as parts of figures commonly used for adoration such as hands, arms, and phallus. Approximate date: 10th millennium B.C. to the 18th century A.D.

e. Small Statuary—This type includes humans, deities (idols), mythological creatures, animals, and groups of figures in the round, as well as parts of figures. Some early examples of human idols are stylized, such as “violin-shaped” figures. Approximate date: 10th millennium B.C. to the 18th century A.D.

f. Small Scale Inlay Sculpture—Small-scale examples include flat, cut-out figures in light-colored stones set against dark stone or bitumen backgrounds. These may decorate boxes or furniture. Subject matter includes narrative scenes such as warfare and banquet scenes. Approximate date: 10th millennium B.C. to the 18th century A.D.

g. Furniture—In limestone, basalt, and marble. Types include tables ( trapezas ), one-legged tables ( monopodias ), thrones, fulcras, and beds. Approximate date: 10th millennium B.C. to the 18th century A.D.

2. Vessels—In marble, steatite, rock crystal, and other stone. These may belong to conventional shapes such as bowls, cups, jars, jugs, and lamps, or may occur in the shape of a human or animal, or part of human or animal. Approximate date: 10th millennium B.C. to the 18th century A.D.

3. Tools and Weapons—In flint, quartz, obsidian, silex, limestone, and other hard stones. Types of stone tools include large and small blades, borers, scrapers, sickles, awls, harpoons, cores, and arrow heads. Ground stone types include grinders ( e.g., mortars, pestles, millstones, whetstones), choppers, axes, hammers, molds, and mace heads. Approximate date: 1.2 million years ago to the 18th century A.D.

4. Seals and Stamps—These are small devices with at least one side engraved with a design for stamping or sealing, often in marble, limestone, and various semiprecious stones including rock crystal, amethyst, jasper, agate, steatite, and carnelian. This category includes seals, scarabs and scaraboids, and gems engraved with a design, scene, pattern, or inscription. Shapes can include cylinders, buttons, and prismatic. Approximate date: 10th millennium B.C. to the 18th century A.D.

5. Jewelry and Beads—Jewelry of or decorated with colored and semi-precious stones, including beads, necklaces, pendants, cameos, crowns, earrings, finger rings, bracelets, anklets, belts, girdles, pins, hair ornaments, and arm bands. May be incised or cut as gems or cameos. Approximate date: 1.2 million years ago to the 18th century A.D.

B. Metal

1. Sculpture

a. Large Statuary and Portraits—Primarily in bronze, in a variety of styles. Subject matter includes human, animal, and mythological figures, icons, busts, and groups of figures in the round, as well as parts of figures commonly used for adoration such as hands, arms, and phallus. Sarcophagi lids, including kline lids with recumbent figures, are also included. Approximate date: 5th millennium B.C. to the 18th century A.D.

b. Small Statuary—In bronze, copper, gold, silver, electrum, iron, and lead. Subject matter includes human, animal, and mythological figures. In early examples, idols representing deities for religious purposes may be very stylized, such as twin idols, or semi-circular idols. Approximate date: 5th millennium B.C. to the 18th century A.D.

c. Reliefs—In bronze, copper, gold, silver, electrum, iron, and lead. Types include plaques, appliqués, burial masks, and leaves. Approximate date: 5th millennium B.C. to the 18th century A.D.

d. Inscribed and Decorated Metal Sheets and Plates—In bronze, copper, gold, silver, electrum, iron, and lead. Thin metal sheets with engraved or impressed designs, often used as attachments to furniture. Approximate date: 5th millennium B.C. to the 18th century A.D.

2. Vessels—In bronze, copper, gold, silver, electrum, iron, and lead. This type includes conventional forms such as pitchers, bowls, cauldrons, jugs, globular flasks ( aryballos ), goblets, phials, ladles, lamps, and candelabra. Objects may be in conventional shapes or may be in human or animal shapes. Approximate date: 5th millennium B.C. to the 18th century A.D.

3. Jewelry and Personal Adornment—In bronze, copper, gold, silver, electrum, iron, and lead. This type includes earrings, ear caps, finger rings, beads, bracelets, cuffs, necklaces, pendants, straight and safety pins ( fibulae ), crowns, wreaths, diadems, fibulas, pectoral decorated sheets, belts, buckles, and textile decorations. Approximate date: 5th millennium B.C. to the 18th century A.D.

4. Tools—This category includes hammers, saws, hooks, axes, chisels, scissors, scrapers ( strigils ), weights, bells, trowels, mirrors, forks, spoons, nails, scales, curling rods ( calamistrum ), locks, keys, ingots, medical tools such as forceps, probes, and cautery tools, and door knockers which may be in the form or human or animal figures. Approximate date: 5th millennium B.C. to the 18th century A.D.

5. Weapons and Armor—In bronze, copper, gold, silver, electrum, iron, and lead. This category includes common weapon types, such as daggers, arrows, swords, spears, harpoons, javelins, axes, rapiers, and maces. Body armor is also included, such as helmets, shields, cuirasses, horse armor, and chariot decoration. Some may have inscriptions or be otherwise decorated. Approximate date: 5th millennium B.C. to the 18th century A.D.

6. Seals and Stamps—These are small devices with at least one side engraved with a design for sealing or stamping, often in bronze, copper, gold, silver, electrum, iron, or lead. Types include rings, amulets, stamps, and seals with shank. Approximate date: 5th millennium B.C. to the 18th century A.D.

7. Ceremonial Objects—Ritual and ceremonial objects pertaining to Turkey's religious communities, in bronze, copper, gold, silver, electrum, iron, and lead. This type includes libation vessels, ritual cauldrons and pitchers, rhytons, masks, chalices, plates, censers, candelabras, crosses, pendants, bells, reliquaries, liturgical spoons, Kiddush cups, book covers and boxes, decorated book spines, Torah pointers, finials, and ampoules. Approximate date: 5th millennium B.C. to the 18th century A.D.

8. Musical Instruments—Trumpets, clappers, sistrums, castanets, cymbalon, aulos, plagiaulos, cornu, lituus, buccina, tuba, hydraulis, lyre, xylophone, and metal parts of other instruments otherwise primarily in wood or bone. Approximate date: 5th millennium B.C. to the 18th century A.D.

9. Coins

a. Greek coins—Archaic coins, dated to 640-480 B.C., in electrum, silver and billon, that circulated primarily in Turkey; Classical coins, dated to 479-332 B.C., in electrum, silver, gold, and bronze, that circulated primarily in Turkey; and Hellenistic coins, dated to 332-31 B.C., in gold, silver, bronze and other base metals, that circulated primarily in Turkey. Greek coins were minted by many authorities for trading and payment and often circulated all over the ancient world, including in Turkey. All categories are based on find information provided in Thompson, M., Mørkholm, O., Kraay, C., Inventory of Greek Coin Hoards, 1973 (available online at http://coinhoards.org/ ) and the updates in Coin Hoards I-X as well as other hoard and single find publications. Mints located in Turkey and surrounding areas are found in Head, B. V., Historia Numorum, A Manual of Greek Numismatics, 1911 (available online at http://snible.org/coins/hn/ ).

b. Roman provincial coins—Roman provincial coins, dated from the end of 2nd century B.C. to the early 6th century A.D., in gold, silver, and bronze and copper that circulated primarily in Turkey.

c. Byzantine period coins—Byzantine period coins, in gold, silver, bronze, copper coins, and sometimes electrum, dating from the early 6th century to the 15th century A.D., that circulated primarily in Turkey, ( e.g., coins produced at mints in Nicaea and Magnesia under the Empire of Nicaea).

d. Medieval and Islamic coins—Medieval and Islamic coins, in gold, silver, bronze, and copper coins from approximately A.D. 1077-1770, that circulated primarily in Turkey.

C. Ceramic, Terracotta, and Faience

1. Sculpture

a. Architectural Elements—Baked clay (terracotta) elements used to decorate buildings. Elements include tiles, roof coverings, antefixes, plates, and decorative elements such as reliefs, votive tablets ( pinakes ), friezes and acroters, and wall decorations such as cones, glazed bricks, and decorated knobs. Approximate date: 2nd millennium B.C. to the 18th century A.D.

b. Sarcophagi and Ossuaries—Sarcophagi and coffins, with separate lids, either in the form of a large rectangular box, or human-shaped and carved with modeled human features. Sarcophagi may be painted, inlaid, and/or decorated with incised or sculpted relief of floral or geometric motifs and inscriptions. Ossuaries are rectangular or in the shape of stylized animals and may be decorated. Approximate date: 2nd millennium B.C. to the 18th century A.D.

c. Large Statuary—Subject matter includes human and animal figures, icons, models, molds, and groups of figures in the round. Common types are large-scale, free-standing statuary approximately 1-2.5 m. in height and life-size busts (head and shoulders of an individual). Approximate date: 5th millennium B.C. to the 18th century A.D.

d. Small Statuary—Subject matter is varied and includes humans, deities (idols), mythological creatures, animals, and groups of figures in the round, as well as parts of figures. These range in height: Approximately 10 cm.-1 m. Approximate date: 5th millennium B.C. to the 18th century A.D.

e. Terracotta Plaques—These are produced by carving or using molds; may have a variety of subject matter. Type also includes molds and models used in production. Approximate date: 5th millennium B.C. to the 18th century A.D.

f. Models—These are small-scale objects in terracotta, including chariots, boats, buildings, and furniture such as chairs and beds. Approximate date: 11th millennium B.C. to the 18th century A.D.

2. Vessels—Ceramic types, forms, and decoration vary among archaeological styles over time. Forms may be handmade or produced with ceramic lathe, plain or decorated, and may be glazed, unglazed, varnished, painted, engraved, and/or incised. They may be produced in Turkey or imported into Turkey at or near the time of production. Some of the most well-known types are highlighted below:

a. Neolithic and Chalcolithic Period—This type includes bowls, cups, jars, pots, urns, and ritual vessels in the shape of a woman or animal. Some examples are painted with yellow, brown, or red; patterns include concentric circles, horizontal lines, and geometric motifs over cream or red slip.

b. Early Bronze Age—This type includes two-handled goblets ( depas amphikypellon ), beak-spouted pitchers, anthropomorphic jars, pedestal bowls, amphorae, vases, double-/triple-/quadruple vessels (two or more cups or bowls attached at a central point to form a single vessel), mugs, boxes, and small pots with lids ( pyxis ).

c. Middle and Late Bronze Age—This type includes Assyrian Trade Colonial, Hittite, and early Mycenaean pottery. In this period, ceramic lathe and glaze techniques became common and forms became thinner. Type includes ceremonial vessels in the shape of animals ( rythons ), plates, double-handled drinking vessels ( kantharos ), bathing bowls, and vases.

d. Geometric, Orientalizing, Archaic, and Classical Periods—This type includes vessels used for holding oil or perfume ( alabastron, lekythos, aryballos, lydion ), jars used for storage ( amphorae, pelike, pithoi, hydria ), pitchers and jugs ( oinochoe, olpe ), boxes for holding cosmetics or jewelry ( pyxis ), drinking cups ( kylix, kantharoi, skyphoi ), tankards, other vessels ( krater, askos ), ceremonial vases ( lebes gamikos ), plates, and lamps. Black-figure technique was common in Greek city-states in Western Anatolia, starting in 7th century B.C. Vessels in this technique are decorated with black painted figures on a clear clay ground. Vessels with red-figure technique (decorative elements in reserve with background fired black) are also common in Western Anatolia. Most black- and red-figure vessels are decorated with scenes of daily life or mythology.

e. Hellenistic and Roman Periods—This type includes vessel forms noted in previous time periods, as well as small bottles ( unguentarium ) and wine jars ( lagynos ). There is less decorative painting in this period; instead, types display simple motifs and/or reliefs. Fine red Roman tableware ( terra sigillata ) is also common.

f. Byzantine Period—Vessel types include amphorae, bowls, plates, chalices, beakers, and special shapes such as pilgrim flasks. Types include red slipwares, as well as glazed and unglazed vessels. Unglazed wares are usually undecorated; other examples may be decorated with various techniques and motifs such as human figures, animals, florals, and other symbolic motifs.

g. Islamic Period—Early examples include green and turquoise vessels that may be in the vessel shapes mentioned above. In addition, this type includes inkstands, chalices, lamps, rose water flasks, censers, incense cases, kitchenware, and tableware. Sizes and shapes are varied; colors include blue-white, red, blue, yellow, purple, and green and may include floral or other painted or inscribed decorations.

3. Objects of Daily Use—This type includes objects of daily use including toys, weights, and lamps. Approximate date: 5th millennium B.C. to the 18th century A.D.

4. Seals, Stamps, and Tablets—This type includes cuneiform tablets from Anatolia during the Assyrian Colonial Period and Hittite Period; some tablets may be encased with a clay envelope. This type also includes seals used to mark ceramics, textiles, leather, other organic materials, and live animals. Approximate date: 5th millennium B.C. to the 18th century A.D.

5. Islamic Period Tiles—Tiles were used mainly for adorning walls, roofs, and floors of buildings such as mosques, masjids, mausoleums, and palaces. During the Seljuk Period, common motifs included star and cross, mythological creatures, human and animal figures, natural and floral motifs, geometric motifs, and inscriptions. During the Ottoman Period, most tiles are decorated with floral motifs, including the saz style with composite flowers and saz leaves. Glazed bricks used in this period are also included. Approximate date: 11th century to the 18th century A.D.

D. Bone, Ivory, and Other Organic Material

1. Small Statuary and Figurines—This type includes human, animal, and other figures in the round. Size may range between 5 cm.-1 m. in height. Approximate date: c. 20,000 B.C. to the 18th century A.D.

2. Objects of Daily Use—This type includes materials in bone, ivory, mother of pearl, seashell, and tortoise shell that may be used as decoration or inlay for architectural elements, furniture, or relief plaques. Type also includes amulets and pendants, other jewelry and beads, buckles, combs, pins, pyxis, boxes, needles, dice, mirror backs, handles, carved diptychs, writing and painting equipment, and musical instruments. Approximate date: 350,000 B.C. to the 18th century A.D.

3. Seals and Stamps—These are small objects with at least one side with engraved designs for stamping or sealing. They may be cuboid, conoid, or in the shape of animals or mythological creatures. Approximate date: 7th millennium B.C. to the 18th century A.D.

4. Weapons and Tools—Bone, ivory, and horn were also used to produce and decorate weapons and tools. In addition to conventional types, such as needles, awls, chisels, picks, knives, spearheads, and blades, these materials were also used for zighir (thumb ring used to draw a bow) and wrist shields. Found as early as 1.2 million years ago.

5. Human and Animal Remains—Skeletal remains from human and animal bodies, preserved in burials or other contexts. Some examples may be plastered or painted with ochre. Found as early as 1.2 million years ago.

E. Wood

1. Architectural Elements—This type includes walls, ceilings, floors, panels, balconies, doors, altars, parts of vaults, minbar, mihrab, muqarnas, decorative elements, ladders, or pieces of any of these objects. May be engraved, painted, inlaid, or otherwise decorated. Approximate date: 9th millennium B.C. to the 18th century A.D.

2. Objects of Daily Use—This type includes furniture such as chairs, stools, beds, tables, chests, and desks; kitchen and tableware, book cases, book holders, lecterns, prayer panels, carved diptychs, writing and painting equipment, games, game boxes, combs, clasps, needles, beads, and musical instruments. May be engraved, painted, inlaid, or otherwise decorated. Approximate date: 9th millennium B.C. to the 18th century A.D.

3. Tools and Weapons—This includes bows, arrows, knives, axe and adze handles, bow drills, and spears. Approximate date: 9th millennium B.C. to the 18th century A.D.

4. Ships and Other Vehicles—This includes whole or pieces used in composing a ship, chariot, or any other vehicle. Approximate date: 7th millennium B.C. to the 18th century A.D.

F. Glass

1. Architectural Elements—This includes glass inlay and tesserae pieces from floor and wall mosaics, mirrors, and windows. Approximate date: 4th millennium B.C. to the 18th century A.D.

2. Vessels—This type includes containers for holding perfume or oil ( alabastron, unguanteria, aryballos ), wine jugs ( oinochoe ), other drinking, storage, and serving vessels of various shapes and sizes, and lighting objects such as lamps. Approximate date: 2nd millennium B.C. to the 18th century A.D.

3. Beads and Jewelry—Jewelry such as bracelets and rings (often twisted with colored glass), pendants, and beads in various shapes ( e.g., circular, globular), may be decorated with symbolic and/or floral motifs. This category also includes beads in various shapes including animal figures. Approximate date: 2nd millennium B.C. to the 18th century A.D.

G. Plaster and Stucco —This category includes various types of objects including containers from the pre-pottery Neolithic onward, column capitals, pedestals, wall murals or paintings and other architectural elements, and vessels and containers. These may be plain or painted and/or gilded. Approximate date: 9th millennium B.C. to the 18th century A.D.

H. Textile —These include linen, wool, cotton, and silk. This category includes clothing or clothing fragments, carpets, sanjaks (flags or banners), flag bags, wall hangings, blankets, and textiles used during religious practice. Approximate date: 9th millennium B.C. to the 18th century A.D.

I. Leather, Parchment, and Paper

1. Leather—This category includes bags, furniture parts, masks, shields, cases and containers for a variety of uses, sandals, clothing, and manuscript covers. There are also examples of religious and/or rare books written on leather pages.

2. Papyrus—Documents made from papyrus and written upon in ink. These are often rolled and/or fragmentary. Approximate date: 5th millennium B.C. to the 12th century A.D.

3. Parchment—Writing material made of animal skin and used to produce manuscripts including religious, liturgical, and scientific works. These may be single leaves or bound as books or scrolls. These may also have illustrations or illuminated paintings with gold and other colors. Approximate date: 3rd millennium B.C. to the 18th century A.D.

4. Paper—This includes manuscripts and individual pages thereof, written on paper and bound as books or scrolls. These may also have illustrations. Approximate date: 8th century to the 18th century A.D.

J. Rock Art, Painting, and Drawing

1. Rock Art—This type includes human-made markings on stone, cave walls, or rocks in open air. This type includes petroglyphs (carved into the rock surface); pictographs (painted); and earth figures (formed on the ground). Subject matter may include human and animal figures, deities, geometric designs, and religious signs and markings. Approximate date: 10th millennium B.C. to the 18th century A.D.

2. Wall Paintings—This category includes paintings from buildings and tombs. Several methods were used, such as wet-fresco and dry-fresco, and the paintings may be applied to plaster, wood, or stone. Types include simple applied color, bands and borders, landscapes, scenes of people and/or animals in natural or built settings, and religious themes. Approximate date: 7th millennium B.C. to the 18th century A.D.

3. Panel Paintings (Icons)—An icon is a work of art for religious devotion, normally depicting saints, angels, or other religious figures. These are painted on a wooden panel, often for inclusion in a wooden screen (iconostasis), or else painted onto ceramic panels. May be partially covered with gold or silver, sometimes encrusted with precious or semi-precious stone. Approximate date: 4th century A.D. to the 18th century A.D.

K. Mosaics —May be a combination of small three-dimensional pieces of colored stone or glass (tesserae) to create motifs such as geometric shapes, mythological scenes, floral or animal designs, natural motifs such as landscapes, and daily chores. The opus sectile technique is also used. These were generally applied to walls, ceilings, or floors. Approximate date: 7th century B.C. to the 18th century A.D.

Ethnological material covered by the agreement includes architectural elements, funerary objects, ritual and ceremonial objects, paintings, written records, and military material that contribute to the knowledge of the origins, development, and history of the Turkish people. This includes objects from the 1st c. A.D. starting in the Roman Empire, through the Byzantine, Seljuk, Beyliks, and Ottoman periods, and ending in A.D. 1923, with the foundation of the Republic of Turkey.

A. Architectural Elements —This category includes architectural elements and decoration from religious and public buildings in all materials. These buildings have distinctive characteristics described below. Examples of architectural elements covered in the Agreement include, but are not limited to, the following objects:

1. Structural and Decorative Architectural Elements—This category includes material from religious or public buildings in stone, ceramic, plaster, wood, and other organic elements, which includes blocks; columns, capitals, bases, lintels, jambs, friezes, and pilasters; panels, doors, door frames, and window fittings; altars, prayer niches (mihrab), screens, iconostasis, fountains, ceilings, tent poles, and carved and molded brick. Metal elements are primarily in copper, brass, lead, and alloys, and may include doors, door fixtures, lathes, finials, chandeliers, screens, and sheets to protect domes. Glass may be incorporated into either structural or decorative elements. This category also includes relief and inlay sculpture, including appliques and plaques that may have been part of a building. May be plain, molded, carved, or inscribed. Decorative motifs may be incised or in high relief.

2. Tiles—Ceramic tiles were often used for adorning walls, roofs, and floors of mosques, masjids, mausoleums, shrines, and palaces. During the Seljuk Period, subject matter included star- and cross-shaped tiles with creatures such as harpies, sphinxes, and double-headed eagles. Human and animal figures were also common, as well as natural motifs such as the tree of life, scrolling branches with pomegranates, floral and geometric patterns, and inscriptions. During the Ottoman Period, subject matter included mainly floral motifs; the saz style motif with composite flowers, smaller rosettes, and saz leaves was also common. This type also includes glazed bricks.

3. Mosaics—May be a combination of small three-dimensional pieces of colored stone or glass (tesserae) to create motifs such as geometric shapes, floral or animal designs, natural motifs such as landscapes, and scenes of religious or historical events. These were generally applied to walls, ceilings, or floors.

B. Funerary Objects —This category includes objects related to funerary rites and burials in all materials. Examples of funerary objects covered in the Agreement include, but are not limited to, the following objects:

1. Sepulchers—Sepulchers are repositories for remains of the dead, in stone (usually marble or limestone), metal, and wood. Types of burial containers include sarcophagi, caskets, coffins, and urns. These may also have associated sculpture in relief or in the round. May be plain or have figural, geometric, or floral motifs either painted or carved in relief. May also contain human or animal remains.

2. Inscriptions, Memorial Stones, Epitaphs, and Tombstones—This category includes inscribed funerary objects, primarily slabs in marble and ceramic; most frequently engraved with Ottoman Turkish, Turkish, Arabic, Greek, Armenian, or Hebrew. These may also have associated sculpture in relief or in the round.

3. Funerary Offerings—This category includes objects in all materials; shrouds and body adornment such as clothing, jewelry, and accessories; idols, figurines, vessels, beads, weapons, or other ritual or ceremonial offerings; and writing implements, books, and manuscripts.

C. Ritual and Ceremonial Objects —This category includes objects for use in religious services (Christian, Islamic, Jewish, and others) or for imperial use by the state (Byzantine Empire, Seljuk Empire, Anatolian Beyliks, and Ottoman Empire). Examples of ritual and ceremonial objects covered in the Agreement include, but are not limited to, the following objects:

1. Religious Objects—This category includes objects in all materials such as lamps, libation vessels, pitchers, chalices, plates, censers, candelabra, crosses and cross pendants, pilgrim flasks, tabernacles, boxes and chests, carved diptychs, liturgical spoons, Kiddush cups, bells, ampoules, Torah pointers and finials, prayer beads, icons, amulets, and Bektashi surrender stones. This type also includes reliquaries and reliquary containers, which may or may not include human remains. Often engraved or otherwise decorated.

2. Imperial—This category includes objects in all materials, such as ceremonial garments, clothing emblematic of imperial position, and other accessories thereof such as shoes, headdresses and hats, belts, and jewelry; objects of imperial office such as scepters, staffs, insignia, relics, and monumental boxes, trays, and containers; flags, flagstaffs, and alem (finials); stamps, seals, and writing implements for official use by the state; tapestries, or other representations of the imperial court; musical instruments; and boats, chariots, and other forms of official transportation, and parts thereof.

3. Furniture—This category includes objects primarily in stone or wood, including altars, tables, platforms, pulpits, fonts, screens, thrones, minbar, lecterns, desks, and other types of furniture used for religious or official imperial purpose.

4. Textiles—Generally in linen, silk, and wool. This category includes textiles and fragments from religious contexts including garments such as tapestries, hangings, prayer rugs and carpets, shrine covers, altar cloths; clothing and accessories such as robes, vestments, kaftans, turbans, hats, and talismanic shirts. Commonly decorated with embroidered designs including religious, floral, and geometric motifs. This category also includes imperial objects such as clothing including vestments and robes; flags and flag bags ( sanjaks ); and carpets and tapestries.

5. Musical Instruments—This category includes instruments important for religious or imperial ceremonies such as a baglama or saz, tambur, rebab, and ud (string instruments); harps; ney (reed flute); pipes; whistles; kudum (small double drum); kos (drum); kanun (zither); trumpets and bugles; and cymbals.

D. Paintings —This category includes works of paint on plaster, wood, or ceramic from religious or public contexts. Paintings from these periods provide information on social and religious history of the people of Turkey that may be absent from written records. Examples of paintings include, but are not limited to:

1. Wall Paintings—This category includes paintings on various types of plaster, which generally portray religious images and/or scenes of Biblical events. Types may also include simple applied color, bands and borders, animal, floral, and geometric motifs.

2. Panel Paintings (Icons)—Icons are smaller versions of the scenes on wall paintings, and may be partially covered with gold or silver, sometimes encrusted with semi-precious or precious stones and are usually painted on a wooden panel, often for inclusion in a wooden screen. May also be painted on ceramic.

3. Works on Paper—Paintings may be on papyrus, parchment, and paper. Images depicted may include religious scenes, representations of imperial court life, simple applied color, bands and borders, animal, floral, and geometric motifs.

E. Written Records —This category includes written records of religious, political, or scientific importance, including, but not limited to, the following. Works may be on papyrus, parchment, paper, or leather. Papyrus documents are often rolled and/or fragmentary. Parchment and paper documents may be single leaves or bound as scrolls or books. They may have illustrations or illuminated paintings with gold or other colors. There are also examples of Qurans and other religious and/or rare books written on leather pages. This category includes boxes for books or scrolls made of wood or other organic materials, and book or manuscript covers made of leather, textile, or metal.

F. Military Material —This category includes imperial military objects from the Byzantine, Seljuk, Beyliks, and Ottoman periods, in all materials.

1. Uniforms—Uniform clothing either meant to be worn under armor or without, is usually made of textile or leather. This includes clothing emblematic of military position, and other accessories thereof such as shoes, headdresses and hats, belts, and jewelry.

2. Weapons and Armor—These are often in iron, steel, or other metal. This category includes arrows, daggers, swords, saifs, scimitars, other blades with or without sheaths, spears, and pre-industrial firearms and cannon; may be for use in combat or ceremonial. May be inlaid with gemstones, embellished with silver or gold, or engraved with floral or geometric motifs. Grips or hilts may be made of metal, wood, or semi-precious stones such as agate, or bound with leather. Armor may consist of small metal scales, originally sewn to a backing of textile or leather. This type also includes helmets, body armor, shields, and horse armor. Other objects may be made of leather, including archer's bags, shields, and masks. This category also includes: Auxiliary objects such as powder horns and belts; military standards; and boats, chariots, or other means of imperial military transportation.

3. Musical Instruments—These instruments were used to encourage and direct military operations. This category includes pipes and other wind instruments, trumpets and bugles, and drums and other percussion instruments such as the çevgan (a long-handled rattle with bells and chimes).

This amendment involves a foreign affairs function of the United States and is, therefore, being made without notice or public procedure under 5 U.S.C. 553(a)(1). For the same reason, a delayed effective date is not required under 5 U.S.C. 553(d)(3).

Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply.

CBP has determined that this document is not a regulation or rule subject to the provisions of Executive Order 12866 because it pertains to a foreign affairs function of the United States, as described above, and therefore is specifically exempted by section 3(d)(2) of Executive Order 12866.

This regulation is being issued in accordance with 19 CFR 0.1(a)(1) pertaining to the Secretary of the Treasury's authority (or that of his/her delegate) to approve regulations related to customs revenue functions.

For the reasons set forth above, part 12 of title 19 of the Code of Federal Regulations (19 CFR part 12), is amended as set forth below:

Troy A. Miller, the Senior Official Performing the Duties of the Commissioner, having reviewed and approved this document, is delegating the authority to electronically sign this notice document to Robert F. Altneu, who is the Director of the Regulations and Disclosure Law Division for CBP, for purposes of publication in the Federal Register .

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and prompt action is needed to respond to the potential safety hazards associated with the Savannah boat parade. The Coast Guard received initial notice of the event on April 26, 2021 regarding the event beginning on July 4, 2021, but did not have final details to prepare a regulation until May 25, 2021. The event would begin before the rulemaking process would be completed. Because of the dangers posed by the parade, a safety zone is necessary to provide for the safety of persons, vessels, and the marine environment in the event area. It is impracticable and contrary to the public interest to delay promulgating this rule because the rule is necessary to protect personnel, vessels, and the marine environment from potential hazards created by the boat parade.

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

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port (COTP) Savannah has determined that potential hazards associated with the boat parade starting July 4, 2021, will be a safety concern for anyone on the Savannah River from the Elba Island Cut Jetty Light to the Eugene Talmage Memorial Bridge, Savannah, GA. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the parade is underway.

This rule establishes a safety zone from 2 p.m. until 5 p.m. on July 4, 2021. The safety zone will cover all navigable waters from the Savannah River from the Elba Island Cut Jetty Light to the Eugene Talmage Memorial Bridge, Savannah, GA. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the bridge is being repaired. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

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

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

This regulatory action determination is based on the size, duration, and scope of the safety zone. The safety zone is limited in duration and size as it will be enforced for only three hours and will cover all navigable waters from the Savannah River from the Elba Island Cut Jetty Light to the Eugene Talmage Memorial Bridge, Savannah, GA. The zone is limited in scope as vessels and persons seeking to transit through the regulated area may seek authority from the COTP or a designated representative. The Coast Guard will provide notification of the regulated area to the local maritime community by Local Notice to Mariners, Broadcast Notice to Mariners via VHF-FM marine channel 16, and a Marine Safety Security Bulletin.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting only 3 hours that will prohibit entry on the Savannah River from the Elba Island Cut Jetty Light to the Eugene Talmage Memorial Bridge. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

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

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

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

On March 16, 2021, the EPA proposed to rescind the FIP for NGS that we promulgated on October 3, 1991 (“1991 FIP”), March 5, 2010 (“2010 FIP”), and August 8, 2014 (“2014 FIP”). 1 The provisions of the 1991 action are codified in the Code of Federal Regulations (CFR) at 40 CFR 52.145(d), the provisions of the 2010 action are codified at 40 CFR 49.5513(a) through (i), and provisions of the 2014 action are codified at 40 CFR 49.5513(j). We refer collectively to the provisions from the 1991, 2010, and 2014 actions as the “FIP” or the “NGS FIP.” The NGS FIP includes federally enforceable emissions limitations that apply to the fossil fuel-fired steam generating equipment, designated as Units 1, 2, and 3, equipment associated with the coal and ash handling, and the two auxiliary steam boilers at NGS. These emissions limitations apply to emissions of particulate matter (PM), opacity, sulfur dioxide (SO 2 ), and oxides of nitrogen (NO X ). The EPA is proposing to rescind the NGS FIP and remove the provisions of the FIP from 40 CFR 52.145(d) and 40 CFR 49.5513.

NGS was a coal-fired power plant that ceased operation in 2019, located on the reservation lands of the Navajo Nation, just east of Page, Arizona, and approximately 135 miles north of Flagstaff. NGS was co-owned by several entities and operated by Salt River Project Agricultural Improvement and Power District (SRP). 2 The facility consisted of three electric generating units, each with a capacity of 750 megawatts (MW) net generation, with a total capacity of 2250 MW. Operations at the facility produced air pollutant emissions, including emissions of SO 2 , NO X , and PM. Pollution control equipment at NGS included wet flue gas desulfurization units for SO 2 and PM removal, electrostatic precipitators for PM removal, and low-NO X burners with separated over-fire air to reduce NO X formation during the combustion process. Had the facility not ceased operations, the owner or operator of NGS would have taken additional steps by December 31, 2019 to reduce emissions of NO X , pursuant to the requirements of the 2014 FIP.

The EPA's proposed action published on March 16, 2021 described the EPA's authority to promulgate a FIP in Indian country, provided an historical overview of the NGS FIP actions, and described the EPA's basis for our proposed action to rescind the NGS FIP, including consideration of whether the rescission of the FIP would interfere with any Clean Air Act requirements. Briefly, because NGS has permanently ceased operation and all equipment subject to the NGS FIP is no longer operational, and because the facility no longer holds a valid CAA title V permit to operate, the EPA proposed to rescind the FIP for NGS at 40 CFR 52.145(d) and 40 CFR 49.5513. Please see our proposed rule for additional details.

The EPA's proposed action provided a 30-day public comment period that ended on April 15, 2021. During this period, the EPA received two comments, one from a private individual and the other from SRP, both in support of our proposed action to rescind the FIP for NGS. 3 We are not providing responses to these comments because they express support for our proposed action.

For the reasons discussed in detail in the proposed rule and summarized herein, the EPA is taking final action to rescind the FIP for NGS at 40 CFR 52.145(d) and 40 CFR 49.5513.

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

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget for review. This rule applies to only one facility and is therefore not a rule of general applicability.

This action does not impose an information collection burden under the PRA because this action does not contain any information collection activities.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities.

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications, as specified in Executive Order 13175. The Navajo Generating Station is located on the reservation lands of the Navajo Nation, and the EPA recognizes there has been significant community and tribal interest in this facility. The facility has already permanently ceased operations and this action simply rescinds previously promulgated requirements applicable to this shuttered facility. In addition, the Navajo Nation EPA has already determined that NGS no longer has the right to operate. This action to rescind the NGS FIP will not have substantial direct effects on any 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. Thus, Executive Order 13175 does not apply to this action. However, on January 7, 2021, we invited the Navajo Nation to consult on this proposed action. 4 The Navajo Nation did not request consultation on this FIP rescission.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.

This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

The EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. The facility has already permanently ceased operations and this action simply rescinds previously promulgated requirements applicable to this shuttered facility. Therefore, the EPA considers this action to have no impacts to human health and the environment, and to have no potential disproportionately high and adverse effects on minority, low-income, or indigenous populations.

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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 16, 2021. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

For reasons discussed in the preamble, EPA amends Chapter I, title 40, of the Code of Federal Regulations as follows:

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

On February 11, 2021, EPA proposed to approve a revision to the Illinois SIP by updating the definition of volatile organic material or volatile organic compound at 35 IAC 211.7150 to exclude (Z)-1,1,1,4,4,4-hexafluorobut-2-ene. See 86 FR 9307. This revision is consistent with an EPA rulemaking exempting this compound from the Federal definition of VOC at 40 CFR 51.100(s) due to its negligible contribution to tropospheric ozone formation. See 83 FR 61127 (Nov. 28, 2018). An explanation of the Clean Air Act (CAA) requirements, a detailed analysis of the revisions, and EPA's reasons for proposing approval were provided in the notice of proposed rulemaking (NPRM) and will not be restated here. The public comment period for this proposed rule ended on March 15, 2021. All the comments received are included in the docket for this action.

During the comment period, EPA received one comment that requested EPA to consider the global warming potential of chemicals for future actions of this type. We do not consider the comment to be germane or relevant to this action and therefore not adverse to this action. The comment lacks the required specificity to the proposed SIP revision and the relevant requirements of CAA section 110. Moreover, the comment does not address a specific regulation or provision, nor does it suggest a change in, or recommend a different action on, the SIP submission from what EPA proposed. Therefore, the comment requires no further response, and we are finalizing our action as proposed.

EPA is approving the revision to the Illinois SIP at 35 IAC 211.7150 by removing 1,1,1,4,4,4-hexafluorobut-2-ene from the definition of VOM and VOC in accordance with the Illinois submittal on October 20, 2020.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Illinois Regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available through www.regulations.gov, and at the EPA Region 5 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the State implementation plan, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 1

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For 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);

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

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

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

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

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

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

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

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

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

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. 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 16, 2021. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2) of the CAA.)

For the reasons stated in the preamble, EPA amends title 40 CFR part 52 as follows:

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

This rule acts on the July 16, 2020 request from the IDEM to incorporate revisions to Indiana's emission reporting rule, 326 IAC 2-6. An explanation of the CAA requirements, a detailed analysis of the revisions, and EPA's reasons for proposing approval were provided in EPA's notice of proposed rulemaking (NPRM), dated February 11, 2021 (86 FR 9036), and will not be restated here.

In the NPRM, EPA provided a 30-day review and comment period for the proposed rule. The comment period ended on March 15, 2021. We received three comments during the comment period. The full comments are in the rulemaking docket, see Addresses for details on accessing the docket.

Two of the comments received were supportive of EPA's action. Comments from a third individual expressed several issues of concern not addressed in EPA's proposed rulemaking. Those comments are summarized and addressed below.

Comment: The commenter asserted that the decision to remove reporting requirements for Lawrenceburg Township and LaPorte County could have permanent impacts on Indiana's citizens. IDEM should reconsider removing the two areas from attainment.

Response: Because Lawrenceburg Township and LaPorte County have demonstrated attainment with the ozone NAAQS, EPA designated them as attainment areas under Section 107(d) of the CAA on June 4, 2018 (83 FR 25776). Consequently, section 182(a)(3)(B) of the CAA authorizes IDEM to remove the emissions reporting requirements for those two areas. The commenter's suggestion that IDEM should remove the ozone attainment designation status for LaPorte County and Lawrenceburg Township in Dearborn County is outside the scope of this rulemaking.

Comment: The commenter noted that the Federal website, Airnow.com, shows acceptable levels of ozone in all the counties involved. The commenter expressed concern about ozone's adverse biophysical impact, especially in those with chronic respiratory conditions, but acknowledged that those impacts of this rulemaking should remain minimal.

Response: EPA agrees that ozone causes adverse health effects. As noted above, EPA has designated both Lawrenceburg Township (Dearborn County) and LaPorte County as areas that have attained the applicable NAAQS for ozone.

Comment: The commenter expressed concern that the proposal did not consider the potential for ozone levels rising in attainment areas and the potential repercussions of not recording ozone levels. The commenter further stated that, if the State discontinues recording ozone emission rates and they rise beyond a safe level, this could cause negative economic impacts and endanger the health of residents.

Response: This action addresses the requirement for stationary sources to report emissions of volatile organic compounds (VOC) and oxides of nitrogen (NO X ). It does not affect Indiana's requirements with respect to ozone monitoring. Indiana remains obligated to meeting ozone monitoring requirements and to continue to quality-assure monitoring data in accordance with 40 CFR part 58, and to enter all data into EPA's air quality system (AQS) in accordance with Federal guidelines. EPA and IDEM continue to monitor ozone to ensure concentrations remain below the NAAQS.

Comment: The commenter claimed that not requiring certain areas to report ozone emissions can lead to ignored regulations and increased pollution. The commenter further noted that, even if an area has good air quality, it is still our responsibility to prevent ozone levels from becoming worse. The commenter suggested that all municipalities involved continue to report ozone levels as if they were not in attainment of the ozone standard.

Response: As discussed previously, this action does not affect Indiana's requirements with respect to ozone monitoring. Indiana remains obligated to meet ozone monitoring requirements and continue to quality assure monitoring data in accordance with 40 CFR part 58, and to enter all data into EPA's AQS in accordance with Federal guidelines. Further, this does not relieve sources in any of the areas from existing controls on ozone precursors. In addition, while sources in Lawrenceburg Township in Dearborn County and LaPorte County are no longer subject to the emissions reporting requirements of 326 IAC 2-6, all areas in the state remain subject to EPA's Air Emission Reporting Rule (AERR) under 40 CFR 51, subpart A. The AERR requires states to collect and report annual emissions directly to EPA, including emissions of all criteria pollutants (and/or precursors) from all sources (point, non-point, on-road, and off-road mobile source types) regardless of an area's attainment status.

Comment: The commenter asserted that ozone levels do not currently impact the economies of the counties mentioned in this action. The commenter expressed the concern, however, that while steel mills play a large part in Indiana's economy, providing jobs and stability, they also contribute to pollution that threatens Indiana's citizens. The commenter further asserted that nitrogen dioxide and ozone pollution cost billions of dollars and lead to millions of premature deaths; and that, by taking precautionary steps, these costs will be reduced in the long run.

Response: These comments address subjects outside the scope of our proposed action. EPA notes, however, that the commenter does not explain (or provide a legal basis for) how the final rule should differ in any way from the proposed action. That being said, it should be reiterated that both EPA and IDEM continue to monitor ozone to ensure concentrations remain below the NAAQS.

EPA is approving the revision to the emission reporting rule, 326 IAC 2-6-1, into Indiana's SIP, as submitted on July 16, 2020, to address the CAA emission statement requirement in section 182(a)(3)(B).

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Indiana Regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available through www.regulations.gov, and at the EPA Region 5 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 1

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For 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);

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

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

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

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

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

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

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

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

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

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. 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 16, 2021. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

For the reasons stated in the preamble, EPA amends title 40 CFR part 52 as follows:

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

This rule approves EGLE's December 18, 2020 submission to revise Michigan's Air Pollution Control Rules, Part 9. Specifically, the State requested that we approve a revision to R 336.1902, Adoption of standards by reference. The background for this action is discussed in detail, and EPA's reasons for proposing approval were provided in EPA's notice of proposed rulemaking (NPRM), dated March 25, 2021 (86 FR 15837), and will not be restated here.

In the NPRM, EPA provided a 30-day review and comment period for the proposed rule. The comment period ended on April 26, 2021. We received no comments on the proposed rule.

EPA is approving the revision to Part 9 into Michigan's SIP, as submitted on December 18, 2020.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Michigan Regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available through www.regulations.gov, and at the EPA Region 5 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 1

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For 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);

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

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

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

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

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

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

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

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

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

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. 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 16, 2021. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2) of the CAA.)

For the reasons stated in the preamble, EPA amends title 40 CFR part 52 as follows:

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

On March 12, 2021, EPA proposed to approve the removal of four lead emissions rules in OAC Chapter 3745-71 from the Ohio SIP (86 FR 14061). Three of the lead emissions rules applied to Master Metals, Inc., a secondary lead smelter facility in Cleveland, Ohio, which has permanently shut down. The remaining lead emissions rule applied to the air quality sampling requirements in OAC 3745-71-03. This rule was removed because these requirements are consolidated into OAC rule 3745-25-02, which is approved into the Ohio SIP. The removal of the four lead emissions rules result in no OAC Chapter 3745-71 rules remaining in the Ohio SIP. An explanation of the CAA requirements, a detailed analysis of the revisions, and EPA's reasons for proposing approval were provided in the notice of proposed rulemaking and will not be restated here. The public comment period for this proposed rule ended on April 12, 2021.

During the comment period, EPA received one comment asking some general questions about the limits. The comment received is included in the docket for this action.

We do not consider the comment as adverse to this action. The comment lacks the required specificity to the proposed SIP revision and the relevant requirements of CAA section 110. Moreover, the comment does not recommend a different action on the SIP submission from what EPA proposed. Accordingly, we are finalizing our action as proposed.

EPA is approving the removal of OAC rules 3745-71-01, 3745-71-03, 3745-71-05, and 3745-71-06 from the Ohio SIP.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. As described in the amendments to 40 CFR part 52 set forth below, EPA is removing provisions of the EPA-Approved Ohio Regulations from the Ohio SIP, which is incorporated by reference in accordance with the requirements of 1 CFR part 51. EPA has made, and will continue to make, the SIP generally available through www.regulations.gov, and at the EPA Region 5 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For 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);

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

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

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

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

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

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

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

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

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

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. 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 16, 2021. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

For the reasons stated in the preamble, EPA amends title 40 CFR part 52 as follows:

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

For this document, we are giving meaning to certain words or initials as follows:

(i) The words or initials Act or CAA mean or refer to the Clean Air Act, unless the context indicates otherwise.

(ii) The initials ADEQ mean or refer to the Arizona Department of Environmental Quality.

(iii) The initials Ag BMP mean or refer to the State of Arizona's Agricultural Best Management Practices program.

(iv) The initials ARS mean or refer to the Arizona Revised Statutes.

(v) The initials CBI mean or refer to confidential business information.

(vi) The initials CFR mean or refer to the Code of Federal Regulations.

(vii) The initials CO mean or refer to carbon monoxide.

(viii) The words EPA, we, us or our mean or refer to the United States Environmental Protection Agency.

(ix) The initials FIP mean or refer to Federal Implementation Plan.

(x) The initials MMBtu/hr mean or refer to million British thermal units per hour.

(xi) The initials NAAQS mean or refer to the National Ambient Air Quality Standards.

(xii) The initials NESHAP mean or refer to the National Emission Standards for Hazardous Air Pollutants.

(xiii) The initials NNSR mean or refer to Nonattainment New Source Review.

(xiv) The initials NO X mean or refer to oxides of nitrogen.

(xv) The initials NSPS mean or refer to New Source Performance Standards.

(xvi) The initials NSR mean or refer to New Source Review.

(xvii) The initials PM 2.5 mean or refer to particulate matter with an aerodynamic diameter of less than or equal to 2.5 micrometers, or fine particulate matter.

(xviii) The initials PM 10 mean or refer to particulate matter with an aerodynamic diameter of less than or equal to 10 micrometers.

(xix) The initials PSD mean or refer to Prevention of Significant Deterioration.

(xx) The initials SER mean or refer to significant emission rate.

(xxi) The initials SIP mean or refer to State Implementation Plan.

(xxii) The initials SO 2 mean or refer to sulfur dioxide.

(xxiii) The words State or Arizona mean the State of Arizona, unless the context indicates otherwise.

(xxiv) The initials TSD mean or refer to the technical support document for this action unless the context indicates otherwise.

On December 23, 2020 (85 FR 83868), the EPA proposed to approve revisions to the ADEQ portion of the Arizona SIP consisting of several rule revisions and demonstrations submitted by the ADEQ related to the ADEQ's CAA NSR permitting program.

First, we proposed to approve a July 22, 2020 SIP submittal from the ADEQ that contains rule revisions and other demonstrations primarily intended to correct deficiencies in the ADEQ's minor NSR program (referred to hereinafter as the “2020 Minor NSR submittal”). The deficiencies being corrected by the 2020 Minor NSR submittal were identified in a November 2, 2015  1 final limited approval and limited disapproval action by the EPA (referred to hereinafter as the EPA's “2015 NSR action”). 2 Our 2015 NSR action was the result of an extensive review of the ADEQ's NSR program, in response to a comprehensive NSR program update submitted by the ADEQ to the EPA in a 2012 SIP revision (referred to hereinafter as the “2012 NSR SIP submittal”). The 2012 NSR SIP submittal represented the ADEQ's first comprehensive update to its SIP-approved NSR program since the 1980s. Our review of the 2012 NSR SIP submittal for compliance with CAA requirements therefore included all aspects of the ADEQ's minor NSR, Prevention of Significant Deterioration (PSD), and nonattainment NSR (NNSR) permitting programs, including NSR-related visibility requirements for major stationary sources. In a May 4, 2018 final rule, 3 we approved revisions to the ADEQ's NSR program, submitted to the EPA in 2017, that corrected a large portion of the deficiencies identified in our 2015 NSR action, primarily related to the PSD and NNSR programs (referred to hereinafter as the “2018 Major NSR action”). Thus, the 2020 Minor NSR submittal that is the subject of our present action addresses the remaining deficiencies from our 2015 NSR action.

Second, our December 23, 2020 proposed action also included our proposed approval of a March 29, 2019 SIP submittal, and a January 14, 2020 supplemental submittal, from the ADEQ. These two submittals are intended to resolve an ADEQ NNSR program deficiency related to the permitting of ammonia as a precursor to PM 2.5 in the West Central Pinal and Nogales PM 2.5 nonattainment areas (the March 29, 2019 submittal and January 14, 2020 supplement are collectively referred to hereinafter as the “Ammonia PM 2.5 NSR submittal”). In a June 22, 2016  4 final limited disapproval rule action, we had identified additional deficiencies in the ADEQ's NNSR program related to PM 2.5 precursors (referred to hereinafter as the EPA's “2016 PM 2.5 precursor action”). In our 2018 Major NSR action, in addition to approving rule revisions to the ADEQ's NSR program, the EPA conditionally approved  5 the ADEQ's NNSR program pursuant to CAA section 110(k)(4) solely with respect to ammonia as a precursor to PM 2.5 under section 189(e) of the Act. 6 We found in our 2018 Major NSR action that the ADEQ's SIP revisions otherwise resolved the deficiencies identified in our 2016 PM 2.5 precursor action. 7 In addition to resolving the deficiency that was the basis for our conditional approval for ammonia as a precursor to PM 2.5 under CAA section 189(e), the Ammonia PM 2.5 NSR submittal also includes other minor and technical rule revisions to the ADEQ's NSR program that we proposed to approve in our December 23, 2020 proposed action. 8

Finally, our December 23, 2020 proposal also included our proposed determination that the ADEQ's SIP-approved NSR program meets the visibility requirements for major NSR programs in 40 CFR 51.307. Accordingly, we proposed to update 40 CFR 52.145(b) to remove the existing visibility FIPs  9 for those stationary sources subject to the ADEQ's permitting jurisdiction.

The EPA's proposal and technical support document (TSD) for this rulemaking action have more information about the content of the ADEQ's SIP submittals (collectively referred to hereinafter as the “2019-20 NSR submittals”), the deficiencies in the ADEQ's NSR program that are being corrected, and our rationale for proposing approval.

The rules that the EPA proposed to approve into the ADEQ's portion of the Arizona SIP are listed in Table 1 of this notice, and the existing SIP-approved rules that we proposed to remove or supersede from the SIP are listed in Table 2 of this notice. The rules are from the Arizona Administrative Code, Title 18—Environmental Quality, Chapter 2—Department of Environmental Quality—Air Pollution Control, Articles 1, 3, and 4. 10 These rules apply to all areas and stationary sources in Arizona for which the ADEQ has permitting jurisdiction. The ADEQ has permitting jurisdiction for the following stationary source categories in all areas of Arizona: Smelting of metal ores, coal-fired electric generating stations, petroleum refineries, Portland cement plants, and portable sources. The ADEQ also has permitting jurisdiction for major and minor sources in the following counties: Apache, Cochise, Coconino, Gila, Graham, Greenlee, La Paz, Mohave, Navajo, Santa Cruz, Yavapai, and Yuma. Finally, the ADEQ has permitting jurisdiction over major sources in Pinal County (currently delegated to Pinal County Air Quality Control District) and any source in Maricopa, Pima, or Pinal County for which the ADEQ asserts jurisdiction.

On January 15, 2021, EPA published in the Federal Register the “National Primary Drinking Water Regulation: Lead and Copper Rule Revisions” (86 FR 4198) (LCRR) with an effective date of March 16, 2021, and a compliance date of January 16, 2024. On January 20, 2021, President Biden issued the “Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis.” (86 FR 7037, January 25, 2021) (Executive Order 13990). Section 1 of Executive Order 13990 states that our nation has an abiding commitment to empower our workers and communities; promote and protect our public health and the environment; and conserve our national treasures and monuments, places that secure our national memory. Where the Federal Government has failed to meet that commitment in the past, it must advance environmental justice. In carrying out this charge, the Federal Government must be guided by the best science and be protected by processes that ensure the integrity of Federal decision-making. It is, therefore, the policy of the Administration to listen to the science, to improve public health and protect our environment, to ensure access to clean air and water, to limit exposure to dangerous chemicals and pesticides, to hold polluters accountable, including those who disproportionately harm communities of color and low-income communities, to reduce greenhouse gas emissions, to bolster resilience to the impacts of climate change, to restore and expand our national treasures and monuments, and to prioritize both environmental justice and the creation of the well-paying union jobs necessary to deliver on these goals. Section 2 of Executive Order 13990 directs the heads of all Federal agencies to immediately review regulations that may be inconsistent with, or present obstacles to, the policy set forth in Section 1 of Executive Order 13990. The January 20, 2021 White House “Fact Sheet: List of Agency Actions for Review,” identified the LCRR as an agency action to be reviewed in conformance with Executive Order 13990 ( https://www.whitehouse.gov/briefing-room/statements-releases/2021/01/20/fact-sheet-list-of-agency-actions-for-review/ ).

In conducting its review, EPA will carefully consider the concerns raised by stakeholders, including disadvantaged communities that have been disproportionately impacted, states that administer national primary drinking water regulations, consumer and environmental organizations, water systems, and other organizations.

Stakeholders have a range of concerns about the LCRR. For example, a primary source of lead exposure in drinking water is lead service lines. Stakeholders have raised concerns that despite the significance of this source of lead, the LCRR fails to require, or create adequate incentives, for public water systems to replace all of their lead service lines. In addition, stakeholders have raised concerns that portions of many lead service lines are privately owned and disadvantaged homeowners may not be able to afford the cost of replacing their portion of the lead service line and may not have this significant source of lead exposure removed if their water system does not provide financial assistance. Other stakeholders have raised concerns regarding the significant costs public water systems and communities would face to replace all lead service lines. Based upon information from the Economic Analysis for the Final Lead and Copper Rule, EPA estimates that there are between 6.3 and 9.3 million lead service lines nationally and the cost of replacing all of these lines is between $25 and $56 billion.

Another key element of the LCRR relates to requiring public water systems to conduct an inventory of lead service lines so that systems know the scope of the problem, can identify potential sampling locations, and can communicate with households that are or may be served by lead service lines to inform them of the actions they may take to reduce their risks. Some stakeholders have raised concerns that the LCRR's inventory requirements are not sufficiently rigorous to ensure that consumers have access to useful information about the locations of lead service lines in their community. Other stakeholders have raised concerns that water systems do not have accurate records about the composition of privately owned portions of lead service lines and also concerns about public water systems publicly releasing information regarding privately owned property.

A core component of the LCRR is maintaining an “action level” of 15 parts per billion (ppb), which serves as a trigger for certain actions by public water systems such as lead service line replacement and public education. The LCRR did not modify the existing lead action level but established a 10 ppb “trigger level” to require public water systems to initiate actions to decrease their lead levels and take proactive steps to remove lead from the distribution system. Some stakeholders support this new trigger level, while others argue that EPA has unnecessarily complicated the regulation. Some stakeholders suggest that the agency should eliminate the new trigger level and instead lower the 15 ppb action level.

Some stakeholders have indicated that the agency has provided too much flexibility for small water systems and that it is feasible for many of the systems serving 10,000 or fewer customers to take more actions to reduce drinking water lead levels than those actions under the LCRR. Other stakeholders have highlighted the limited technical, managerial, and financial capacity of small water systems and support the flexibilities provided by the LCRR to all of these small systems.

Stakeholders have divergent views of the school and childcare sampling provisions of the LCRR; some believe that the sampling should be more extensive, while others do not believe that community water systems should be responsible for provisions and that such a program would be more effectively carried out by the school and childcare facilities.

Finally, some stakeholders have expressed concerns that the agency did not provide adequate opportunities for a public hearing and did not provide a complete or reliable evaluation of the costs and benefits of the proposed LCRR.

In addition, the LCRR has been challenged in court by the Natural Resources Defense Council, Newburgh Clean Water Project, NAACP, Sierra Club, United Parents Against Lead, and the Attorneys General of New York, California, Illinois, Maryland, Minnesota, New Jersey, Oregon, Pennsylvania, Wisconsin, and the District of Columbia. Those cases have been consolidated in Newburgh Clean Water Project, et al. v EPA, No. 21-1019 (D.C. Cir.). EPA also received a letter on March 4, 2021, from 36 organizations and 5 individuals requesting that EPA suspend the March 16, 2021 effective date of the LCRR to review the rule and initiate a new rulemaking. EPA also received a letter on February 4, 2021, from the American Water Works Association requesting that EPA not delay the rule.

Consistent with Executive Order 13990 and the Memorandum for the Heads of Executive Departments and Agencies titled, “Regulatory Freeze Pending Review” (86 FR 7424, January 28, 2021), EPA decided to review the LCRR. EPA published a final rule on March 12, 2021 (86 FR 14003), which provided for a short delay of the LCRR's effective date from March 16, 2021 to June 17, 2021, to allow the agency to seek comment on a separate proposal, also published on March 12, 2021 (86 FR 14063), to extend the effective date further to December 16, 2021. EPA explained that the further delay was needed to allow the agency adequate time to conduct a thorough review of the complex set of LCRR requirements and to assess whether the regulatory changes are inconsistent with, or present obstacles to, the policy set forth in Section 1 of Executive Order 13990, and to consult with stakeholders, including those who have been historically underserved by, or subject to discrimination in, Federal policies and programs prior to the LCRR going into effect. In the proposal, EPA also sought comment on an extension of the compliance dates by nine months from January 16, 2024, to September 16, 2024.

The LCRR's effective date ( i.e., when the rule is codified into the Code of Federal Regulations ) is different from the compliance dates. Section 1412(b)(10) of the Safe Drinking Water Act (SDWA) specifies that drinking water regulations shall generally take effect ( i.e., require compliance) three years after the date the regulation is promulgated. 1 This 3-year period is used by states to adopt laws and regulations in order to obtain primary enforcement responsibility (primacy) for the rule and by water systems to take any necessary actions to meet the compliance deadlines in the rule. EPA is extending the January 16, 2024 compliance date in the LCRR by nine months to October 16, 2024, to correspond to the delay in the effective date. EPA set the compliance date to October 16, 2024, to be consistent with its intent, described in the proposal, to provide a full nine month delay, to maintain the same time period between the effective date and the compliance date in the LCRR, published on January 15, 2021. EPA expects that the duration of the compliance date extension will provide drinking water systems with adequate time to take actions needed to assure compliance with the LCRR after it takes effect.

EPA recognizes that under Section 1413(a)(1) and 40 CFR 142.12(b), states must submit complete and final requests for approval of program revisions to adopt new or revised EPA regulations not later than two years after promulgation of the LCRR (with the possibility for an extension of up to two years based on certain criteria in EPA's regulations). After completion of the stakeholder engagement process, EPA will consider whether to let the rule take effect on December 16, 2021, with a compliance deadline of October 16, 2024, or whether the agency intends to initiate a new rulemaking to withdraw or modify the LCRR. At that time, EPA and states will have greater clarity with respect to the primary enforcement (primacy) application process and relevant timeframes. If EPA decides to withdraw the LCRR before it takes effect, then there will be no revised regulation that triggers the duty for primacy agencies to submit a program revision to EPA since the previous regulation ( i.e., those regulations that are in place until such time that the LCRR takes effect) will remain in effect. If EPA modifies the LCRR, the agency will establish a new deadline for primacy applications as a part of that regulatory action. If EPA decides to make no further changes to the rule, the agency intends to use the date on which EPA announces that decision in the Federal Register —no later than December 16, 2021—as the promulgation date for the LCRR for purposes of the primacy revision application deadline under 40 CFR 142.12(b)(1). Accordingly, EPA recommends that states consider each of these possibilities in their planning and resource allocation decision-making and that states do not submit primacy applications to the agency at this time because EPA is not expecting to begin review of primacy packages until there is more certainty as to the agency's path forward on the LCRR.

The impact of lead exposure, including from drinking water, is a public health issue of paramount importance and its adverse effects on children and the general population are serious and well known. For example, exposure to lead is known to present serious health risks to the brain and nervous system of children. Lead exposure causes damage to the brain and kidneys and can interfere with the production of red blood cells that carry oxygen to all parts of the body. Lead has acute and chronic impacts on the body. The most robustly studied and most susceptible subpopulations are the developing fetus, infants, and young children. Even low-level lead exposure is of particular concern to children because their growing bodies absorb more lead than adults do, and their brains and nervous systems are more sensitive to the damaging effects of lead. EPA estimates that drinking water can make up 20 percent or more of a person's total exposure to lead. Infants who consume mostly formula mixed with tap water can, depending on the level of lead in the system and other sources of lead in the home, receive 40 to 60 percent of their exposure to lead from drinking water used in the formula. Scientists have linked lead's effects on the brain with lowered intelligence quotient (IQ) and attention disorders in children. Young children and infants are particularly vulnerable to lead because the physical and behavioral effects of lead occur at lower exposure levels in children than in adults. During pregnancy, lead exposure may affect prenatal brain development. Lead is stored in the bones and it can be released later in life. Even at low levels of lead in blood, there is an increased risk of health effects in children ( e.g., less than 5 micrograms per deciliter) and adults ( e.g., less than 10 micrograms per deciliter).

The 2013 Integrated Science Assessment for Lead and the Health and Human Services National Toxicology Program Monograph on Health Effects of Low-Level Lead have both documented the association between lead and adverse cardiovascular effects, renal effects, reproductive effects, immunological effects, neurological effects, and cancer. EPA's Integrated Risk Information System (IRIS) Chemical Assessment Summary provides additional health effects information on lead.

Because of disparities in the quality of housing, community economic status, and access to medical care, lead in drinking water (and other media) disproportionately affects lower-income people. Minority and low-income children are more likely to live in proximity to lead-emitting industries and to live in urban areas, which are more likely to have contaminated soils, contributing to their overall exposure. Additionally, non-Hispanic black individuals are more than twice as likely as non-Hispanic whites to live in moderately or severely substandard housing, which is more likely to present risks from deteriorating lead based paint. The disparate exposure to all sources of environmental lead experienced by low-income and minority populations may be exacerbated because of their more limited resources for remediating lead service lines, which if present in a home, can be a significant source of lead exposure.

For example, stakeholders have raised concerns that, to the extent water systems rely on homeowners to pay for replacement of customer-owned portions of lines, lower-income homeowners may be unable to afford to replace lines, resulting in disparate levels of protection. In addition, a higher incidence of renting among lower-income people may prevent residents from removing lines where the property owner does not consent or finance replacement of the customer-owned portion of the line. Moreover, the crisis in Flint, Michigan, has brought increased attention to the challenge of lead in drinking water systems across the country.

Prior to EPA's actions to delay the effective and compliance dates of the LCRR, litigants and stakeholders had expressed a wide range of concerns about the LCRR's requirements that addressed both the rule's ability to protect public health and the implementation burden that will be placed on systems and states. Specific components of the rule for which concerns have been raised include: The 15 parts per billion (ppb) action level; the 10 ppb trigger level; the lead service line inventory requirements, the lead service line replacement requirements; the flexibility given to small systems; and the sampling of drinking water at schools and child care facilities.

Given the paramount significance to the public's health for ensuring that lead in drinking water is adequately addressed under the SDWA, and the concerns raised by litigants and other stakeholders about the LCRR, it is critically important that EPA's review of the LCRR be deliberate and have the benefit of meaningful engagement with the affected public, including overburdened and underserved communities disproportionately affected by exposure to lead, prior to the rule going into effect.

In the proposed rulemaking, EPA solicited public comment on “the duration of the effective date and compliance date extensions and whether the compliance date extension should apply to the entire LCRR or certain components of the final rule.” A summary of the comments received on the extensions, as well as the agency's responses is provided in this section.

The majority of commenters expressed support for the delay of the effective and compliance dates of the LCRR. These commenters, representing states, water systems, environmental and public health organizations, provided a number of reasons for their support as well as suggestions for how EPA should utilize the additional time. Commenters indicated that the delay would allow time for the agency to conduct a more thorough and complete review, collect and analyze new data, engage with stakeholders, and hold public meetings to solicit further comment on the LCRR as it relates to state and local implementation of drinking water standards, public health protections, lead in school drinking water issues, and specifically to listen to people who are living in communities disproportionately affected by exposure to lead and underserved communities suffering from lead-contaminated drinking water about their recommendations for the rule. Several commenters urged EPA to suspend the March 16, 2021 effective date of the LCRR to review the rule and initiate a new rulemaking to address issues with the rule published in the Federal Register on January 15, 2021 at 86 FR 4198. Commenters also expressed support for the 9-month compliance date extension from the current compliance date of January 16, 2024. Commenters stated that if the rule's effective date were delayed from March 16, 2021, to December 16, 2021, the compliance date should be delayed the same amount of time, ensuring that utilities do not lose any of the time they had been expecting to have available to implement the rule once there is regulatory certainty. Additional commenters indicated that the extension of the compliance date would allow resource-constrained systems and communities needed time to implement the regulatory requirements of the LCRR in general, and more specifically, the lead service line (LSL) inventory and school and child care facility monitoring requirements. Two commenters indicated that the compliance date should be delayed as long as possible.

EPA agrees with commenters that support a delay of the effective date of the LCRR to December 16, 2021. This time is necessary and sufficient to accommodate a thorough review of the requirements of the LCRR and engage with a wide range of stakeholders, including disproportionally affected and underserved communities on the issue of controlling lead in drinking water. The additional 6-month delay of the June 17, 2021 effective date to December 16, 2021, is necessary to develop, publicize, and implement a public engagement process that accommodates the significant and widespread public interest in this rulemaking, coupled with the time needed to compile and evaluate input received during the public engagement process and make a decision as to whether to let the LCRR as published take effect or initiate a rulemaking to withdraw or modify the rule. EPA is currently implementing a public engagement plan that includes public listening sessions, community, tribal, and stakeholder roundtables, and a co-regulator meeting in addition to receiving written public comment on the LCRR as part of its engagement process. EPA believes that the extension of the effective date to December 16, 2021, is sufficient for the review of the LCRR in accordance with Executive Order 13990.

EPA also agrees with commenters that support the 9-month delay of the compliance date. The SDWA typically provides a 3-year time period for drinking water systems and states to assure compliance with new or revised drinking water standards. If the compliance date is not delayed, systems and states would expend resources now to assure compliance with the LCRR by January 16, 2024, particularly given the significant effort required to develop the LSL inventory, LSL replacement plan, and to re-evaluate the tap sampling locations used in their sampling pool, all of which are required before the compliance date and underpin the implementation of the larger requirements of the LCRR. EPA estimated in the economic analysis of the final LCRR that systems and states would spend between $57-60 million, in 2016 dollars, in the first year following promulgation of the rule, working towards compliance by January 16, 2024. The majority of these funds are spent by systems to read and understand the new regulatory requirements, develop implementation plans, train staff, and participate in trainings and technical assistance interactions with the states; and by states to adopt the rule and develop the changes needed to their implementation programs, modify their data systems, provide training to their staff, and provide training and technical assistance to the regulated systems.

If EPA determines to initiate a rulemaking to withdraw the LCRR or significantly revise it as a result of the Executive Order 13990 review process, then these compliance expenditures might be unnecessary to comply with applicable regulatory requirements. Without a delay in the effective and compliance dates of the rule, states and regulated entities may make decisions and spend scarce resources on compliance obligations that could change at the end of EPA's review period. To avoid imposing unnecessary costs on water systems and states, and to allow systems and states sufficient time to prepare for compliance once regulatory certainty has been achieved, EPA has determined to delay both the effective and compliance dates of the LCRR to December 16, 2021, and October 16, 2024, respectively.

EPA received a small number of comment letters that, in general, supported a delay in the effective date and compliance dates, but did not want the agency to delay the implementation of some of the regulatory requirements they felt would increase public health protection. These commenters indicated that the following improvements could be implemented during EPA's reconsideration of the other aspects of the LCRR: The LSL inventory requirements, improved corrosion control treatment requirements, and strengthened monitoring provisions, including provisions that would prevent sampling that is likely to underestimate the actual lead levels in drinking water. Other commenters indicated that any delay to the LCRR effective date and compliance date must apply to the entire LCRR given the interrelated nature of the different aspects of the rule. According to these commenters, having the compliance date extension apply to the LCRR in its entirety will simplify communication, reduce complexity and confusion, improve compliance by the regulated community, and provide additional time to obtain the data management tools and resources required to implement the rule.

Because there is only one effective date for the LCRR, it can take effect or be withdrawn only in its entirety. EPA cannot selectively allow some aspects of the rule to become effective in advance of other parts of the rule without undertaking a separate notice and comment rulemaking. While EPA could establish different compliance dates for different parts of the LCRR as part of a notice and comment rulemaking, the agency has determined not to do so at this time because it would pre-determine the outcome of the public stakeholder process, create confusion for implementing authorities and regulated entities, impose potentially unnecessary costs, and undermine the re-evaluation process by diverting agency and stakeholder resources that would otherwise be devoted to the re-evaluation process. EPA is currently seeking input on all aspects of the rule as part of the stakeholder engagement process. To proceed with implementation of selected portions of the rule during EPA's review of the entire rule would be both impractical and inconsistent with the agency's stated intention to re-evaluate the LCRR in light of stakeholder input on the entire LCRR. Moreover, as explained in the proposal, stakeholders have raised concerns with nearly all aspects of the LCRR, including the LSL inventory requirements. Therefore, EPA has determined to delay the effective date and all of the compliance dates in the rule at this time.

EPA received a total of four comment letters indicating opposition to the extensions of the effective and compliance dates, and an additional two that did not explicitly support or oppose the delay in the effective and compliance dates of the LCRR. In general, the commenters opposing the extensions stated that delaying the effective and compliance dates would delay the public health improvements that would be achieved with implementing the LCRR, in part or in total, as finalized on January 15, 2021.

The comments opposing a delay in the compliance deadline include the following, from the Association of Metropolitan Water Agencies (AMWA), which stated that it “has concerns that EPA's proposal to delay the effective date . . . would postpone the significant public health improvements that will be achieved by implementing the rule as finalized.” They go on to state, “the benefits of this [delay] must be weighed against the costs of postponing the public health improvements that will be achieved when water systems begin to comply with the final rule in its current form.” AMWA identifies the customer-initiated LSL replacement provision, the LSL inventory, and the school and child-care testing provisions as public health improvements that would be postponed by a delay of the rule effective and compliance dates. Also, the Kentucky and Tennessee Water Utility Councils (KY/TN WUC) of the American Water Works Association stated that they “are concerned that extending the dates of the Rule could delay the enhanced awareness, detection, communication, and elimination of potential lead exposure in communities.” Another public commenter opposed the effective and compliance date extensions, arguing that EPA should instead simultaneously implement and revise the LCRR because of certain aspects of the rule that the commenter claims “would provide immediate public health benefits”—such as the LSL inventory and associated public notification requirements, as well as changes in the sampling requirements.

Similarly, one anonymous commenter argued that to delay the rule is tantamount to repeal of the rule and that EPA has not analyzed the effects on human health of the delay that the LCRR was designed to benefit, or considered why it is worth forgoing the benefits of the rule for nine months in exchange for evaluation of the LCRR which, the commenter claims, could be done without delaying the compliance dates. The commenter also claims that EPA has failed to provide a meaningful opportunity for the public to comment “[b]ecause of these substantive oversights, including the failure to consider the merits of the LCRR and the deficiencies of the preexisting requirements in its proposal that would allow those preexisting requirements to remain in effect for a longer period of time.”

The KY/TN WUC opposed the delay of the LCRR effective and compliance dates, noting that EPA has already conducted extensive outreach during the development of the LCRR, stating, “EPA's thorough and extensive review and stakeholder engagement process resulted in a final Rule that strengthens every aspect of the current rule and accelerates actions that can reduce lead in drinking water.” This concept of EPA having already conducted extensive outreach was echoed by AMWA, noting that the agency “has been discussing options for the rule with these communities, other stakeholders, and the public since at least 2010.” However, AMWA “agrees that engagement with at-risk communities is critical.” The commenter opposing the delay and arguing that EPA should simultaneously implement and revise the LCRR, also expressed support for EPA's effort to seek additional stakeholder input on the LCRR. Another comment letter, from the American Water Works Association (AWWA) recommended that EPA consider the extensive outreach that the agency has already conducted on the LCRR.

EPA received two comment letters that did not explicitly support or oppose the delay in the effective and compliance dates of the LCRR. One comment letter, jointly signed by the U.S. Conference of Mayors, the National League of Cities, and the National Association of Counties, indicated that the LCRR as published on January 15, 2021, at 86 FR 4198 “satisfactorily addressed the local government perspective in both protecting public health and reducing lead contamination of drinking water.” Another comment letter from AWWA requests that the effective and compliance dates be extended in an amount commensurate with the additional time used for stakeholder outreach. AWWA noted that the “[u]ncertainty . . . which is naturally generated through reconsideration efforts” will make it difficult for public water systems to prepare for compliance and make investments needed to meet the interrelated requirements of the rule, as such efforts may prove to be wasted or wasteful if the Rule ultimately changes in its particulars.” Accordingly, AWWA requests that “all extensions to the effective date of the LCRR and any subsequent agency activity that seeks to change the LCRR should be accompanied by an extension to the compliance timeframes.” AMWA, though opposing the delays in the LCRR implementation, also expressed support for an extension of the compliance dates by nine months if EPA delays the June 17, 2021 effective date of the rule.

For reasons discussed in the proposal and this action, EPA disagrees with the commenters asserting that the LCRR, as published on January 15, 2021, at 86 FR 4198, should take effect on June 17, 2021. EPA provided a reasoned explanation in the proposal for the delayed effective and compliance dates while the agency conducts this re-evaluation. The explanation identified EPA's concern that water systems and states could unnecessarily expend significant resources on compliance with a rule that may ultimately be withdrawn or substantially modified and, which many commenters have urged, may not be a sufficient improvement in public health protection in comparison to the existing protection of the LCR, or even possibly reduce public health protections.

This action will enable EPA to engage with communities, stakeholders, tribes, and states to gather more information about their concerns with the LCRR and to share information about actions that can reduce drinking water lead exposure. The LCRR virtual engagement process is providing benefits in three ways. First, the engagement is increasing public and community awareness of the potential harmful health effects of lead and the ways individuals and communities may proactively reduce their exposure. Because the effective implementation of drinking water lead reduction requirements, such as LSL replacement, depends on the actions of both water systems and private citizens, the increased awareness fostered by EPA's LCRR review outreach activities will improve the implementation of the LCRR and/or a future lead in drinking water regulatory action. Second, the information gained by the agency from listening to the public and communities that have been dealing with lead in drinking water issues across the country will provide EPA with new information that will help in the development of more effective implementation guidance for the LCRR or any future revisions of the LCRR. Information gathered from this process may be especially useful for the guidance on developing the initial LSL inventory and the LSL replacement plan. Third, the delay of the effective date, to engage with communities, will allow the agency to potentially develop future regulatory revisions to the Lead and Copper Rule, consistent with Executive Order 13990, that will be more effective at reducing the lead in drinking water in real world communities and better at targeting disadvantaged underserved communities.

EPA's economic analysis of the LCRR supports the conclusion that the relatively-short delay in the effective date and compliance dates for this rule, in particular, will not significantly reduce the benefits of the LCRR. The economic analysis of the final LCRR estimated that the annual total incremental cost of the regulatory requirements, in 2016 dollars, would range from $161 to $335 million at the 3 percent discount rate, and $167 to $372 million at the 7 percent discount rate. The annual total incremental monetized benefits, in 2016 dollars, of the final rule were estimated to be between $223 to $645 million, at a 3 percent discount rate, and $39 to $119 million at the 7 percent discount rate. The delay of the original compliance date, of January 16, 2024, by nine months pushes back in time both the cost born by complying entities and the monetized benefits received by the public as a result of lower lead levels in drinking water, by nine months, assuming all other environmental and regulatory conditions remain the same. EPA selected the conservative assumption of modeling a one year delay in the regulatory costs and benefits impacts. The estimated annual total incremental cost of the rule given the one-year delay ranged from $153 to $320 million, at the 3 percent discount rate, and $155 to $346 million at the 7 percent discount rate, in 2016 dollars. The monetized annual incremental benefits, in 2016 dollars, given a one-year delay of the compliance date would range from $213 to $616 million, at the 3 percent discount rate, and $37 to $111 million at the 7 percent discount rate. The estimated change in the monetized incremental annualized social costs and benefits of the delay in the compliance date are approximately of equal size over the 35-year period of analysis ($7 to $27 million for costs and $3 to $29 million for benefits in 2016 dollars), but, as previously discussed, the expected first year (post rule effective date) expenditures by systems and states would be between $57-60 million, in 2016 dollars. These first-year expenditures to prepare for regulatory compliance with the LCRR could be unnecessary if EPA determines to initiate a rulemaking to withdraw or significantly revise the LCRR as a result of the Executive Order 13990 review process. The estimated first year (post rule effective date) benefits are zero given that the regulatory requirements that produce monetized benefits are not implemented until the compliance date three years after the effective date.

Moreover, EPA notes that there is an existing National Primary Drinking Water Rule, the Lead and Copper Rule, that will continue to provide public health protection and benefits during this short delay in the most recent revisions to that rule. Water systems will continue to implement the LCR, which includes requirements to monitor for lead and optimize corrosion control treatment.

Given the relatively small impact to the stream of monetized social costs and benefits over the 35-year period of analysis, which has the potential to dramatically change based on the results of EPA's Executive Order 13990 review process, the significant and potentially unnecessary implementation expenses estimated in the first year following the original effective date, of March 16, 2021; the need to provide systems and states sufficient time to prepare for compliance; the potential positive gains to implementation and collection of new information; and, the existing safeguards to protect against lead contamination in drinking water, EPA has determined to delay both the effective and compliance dates of the LCRR to December 16, 2021, and October 16, 2024, respectively.

EPA also disagrees with those commenters that suggested EPA let the LCRR take effect on June 17, 2021, and then initiate a process to revise it. Although EPA carefully considered whether to allow the rule to take effect on June 17, 2021, while postponing the compliance dates for only certain aspects of the rule, EPA has determined not to do so at this time because it would pre-determine the outcome of the public stakeholder process, create confusion for implementing authorities and regulated entities, impose potentially unnecessary costs, and undermine the re-evaluation process by diverting EPA and stakeholder resources that would otherwise be devoted to the re-evaluation process. Moreover, as explained in the proposal, stakeholders have raised concerns with nearly all aspects of the LCRR, including the LSL inventory requirements. Accordingly, EPA has determined that this approach, to let the rule take effect while postponing compliance dates for some aspects of the rule, is not appropriate at this time.

EPA agrees that in developing the LCRR it has already conducted extensive stakeholder engagements. However, to the extent commenters are suggesting that additional stakeholder input is not warranted at this time, the agency disagrees. EPA did not conduct any public meetings on the LCRR revisions in the two years prior to promulgation of the final rule, which includes the time period between the proposal and the final rule. Similarly, in the two years preceding promulgation of the final rule, EPA did not conduct any targeted meetings to get input on the proposed revisions from communities historically underserved by, or subject to discrimination in, Federal policies and programs, or those communities that have been significantly affected by lead in drinking water. The information shared by these communities could prove to be valuable in understanding potential rule implementation issues that could lead to improved and more effective LCRR requirements and implementation guidance. As discussed previously, EPA agrees with commenters that the delay of the effective date warrants a delay in the compliance dates for the rule. EPA's re-evaluation of the LCRR creates regulatory uncertainty during the 3-year time period typically provided for drinking water systems and states to assure compliance with new or revised drinking water standards. If the compliance date is not delayed, systems and states would expend resources now, to assure compliance with the LCRR by January 16, 2024. EPA estimated in the economic analysis of the final LCRR that systems and states would spend between $57-60 million, in 2016 dollars, in the first year following promulgation of the rule working towards compliance. If EPA were to initiate a rulemaking to withdraw or significantly revise the LCRR, then these compliance expenditures would be unnecessary to comply with applicable regulatory requirements. Therefore, EPA is delaying the compliance date of the LCRR to October 16, 2024, to avoid imposing these potentially unnecessary costs on water systems and states, and to allow systems and states sufficient time to prepare for compliance once regulatory certainty has been achieved.

EPA has complied with the applicable Administrative Procedure Act and SDWA requirements for this rule. If EPA decides that further regulatory changes are necessary, EPA will comply with the applicable requirements of the Administrative Procedure Act and the SDWA, and conform to the relevant EOs, including EOs 13132 and 13175, regarding federalism and tribal consultations, respectively.

Many commenters on the proposal to extend the effective and compliance dates also provided input on all aspects of the LCRR, including the action and trigger levels, LSL inventories, LSL replacement requirements, as well as the requirements for optimal corrosion control treatment, tap sampling, public education and notification, and school sampling, and EPA's compliance with both the substantive and procedural requirements for promulgation of a revised drinking water regulation. The extent and breadth of these comments demonstrates the significant concern that stakeholders, from a range of perspectives, have with the LCRR and the procedures EPA followed in promulgating the rule. EPA appreciates this input on the LCRR and is considering these comments as part of its re-evaluation process.

This final rule extends the effective date of the National Primary Drinking Water Regulations: Lead and Copper Rule Revisions (LCRR) to December 16, 2021. This rule also extends the compliance date to October 16, 2024.

The significant factual, legal, and policy issues identified by stakeholders and litigants, and summarized in Section II of this document, warrant careful and considerate review of the rule, as well as relief from the compliance deadlines as EPA considers these issues. After publication of the final National Primary Drinking Water Regulation, states and water systems commence activities to achieve compliance with the rule by the deadline established in the LCRR based on the requirements of Section 1412(b)(10) of the SDWA. Under the final rule promulgated on January 15, 2021, water systems will begin the actions to prepare LSL inventories, and, as appropriate, to prepare LSL replacement plans. The postponement of compliance dates through this action is intended as a stopgap measure to prevent the unnecessary expenditure of resources by water systems on those efforts until EPA completes its review of the LCRR and can provide some certainty that the regulatory requirements will not be changed. Without a delay in the effective and compliance dates of the rule, regulated entities may make decisions and spend scarce resources on compliance obligations that could change at the end of EPA's review period.

Section 1412(b)(9) of the SDWA authorizes EPA to review and revise national primary drinking water rules “as appropriate” and directs that any revision “shall maintain, or provide for greater, protection of the health of persons.” 42 U.S.C. 300g-1(b)(9). This delay is consistent with EPA's exercise of this discretionary authority to revise its drinking water rules.

EPA will engage with stakeholders during this time period to evaluate the rule and determine whether to initiate a process to revise components of the rule. If EPA decides to withdraw the LCRR, the agency will propose, take comment on, and issue a withdrawal prior to December 16, 2021. If EPA decides it is appropriate to modify the LCRR, it will consider whether those modifications warrant further extensions to compliance dates for the requirements that will be modified to provide time to promulgate those revisions before water systems and states must take actions to comply. If EPA decides to revise the LCRR, the agency will follow the requirements of the SDWA and other applicable statues and EOs to propose and promulgate those revisions.

Section 553(d) of the Administrative Procedure Act (APA), 5 U.S.C. Chapter 5, generally provides that rules may not take effect until 30 days after they are published in the Federal Register . The purpose of this APA provision is to “give affected parties a reasonable time to adjust their behavior before the final rule takes effect.” Omnipoint Corp. v. Fed. Commc'n Comm'n, 78 F.3d 620, 630 (D.C. Cir. 1996); see also United States v. Gavrilovic, 551 F.2d 1099, 1104 (8th Cir. 1977) (quoting legislative history). However, when an agency grants or recognizes an exemption or relieves a restriction, affected parties do not need a reasonable time to adjust because the effect is not adverse. Thus, APA Section 553(d) allows an effective date less than 30 days after publication for any rule that “grants or recognizes an exemption or relieves a restriction” (see 5 U.S.C. 553(d)(1)). An accelerated effective date may also be appropriate for good cause pursuant to APA Section 553(d)(3) where an agency can “balance the necessity for immediate implementation against principles of fundamental fairness, which require that all affected persons be afforded a reasonable amount of time to prepare for the effective date of its ruling.” Gavrilovic, 551 F.2d at 1105.

EPA has determined that this final rule is effective immediately upon publication because it relieves a restriction by extending the effective date and compliance deadlines of the LCRR, thereby providing water systems with additional time to come into compliance. In addition, there is good cause for immediate implementation of these provisions because, as previously explained, the impact of this rule is to ensure that water systems do not unnecessarily expend resources to come into compliance with the LCRR until EPA concludes its review and stakeholder engagement process and makes a decision as to whether to revise the LCRR in whole or in part or to let it take effect as published on January 15, 2021.

This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. Any changes made in response to OMB recommendations have been documented in the docket.

This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2040-0204. This action delays of the effective and compliance dates of the LCRR until December 16, 2021 and October 16, 2024, respectively, and does not alter any of the information collection activities required under the LCRR.

EPA certifies that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. This action delays compliance with the regulatory requirements of the LCRR and does not impose any additional requirements on either large or small entities. EPA has therefore concluded that this action will have no net regulatory burden for all directly regulated small entities.

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the National Government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications as specified in Executive Order 13175. The Executive order defines tribal implications as “actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.” The delay of the effective and compliance dates of the LCRR until December 16, 2021 and October 16, 2024, respectively, will not have a substantial direct effect on one or more tribes, change the relationship between the Federal Government and tribes, or affect the distribution of power and responsibilities between the Federal Government and Indian Tribes. Thus, Executive Order 13175 does not apply to this action.

EPA interprets Executive Order 13045 as applying only to those regulatory actions that are economically significant, per the definition of “covered regulatory action” in Section 2-202 of the Executive order. This action is not subject to Executive Order 13045 because the delays of the effective and compliances dates, until December 16, 2021 and October 16, 2024, respectively, do not have a significant economic impact.

This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. EPA has concluded that the delay of the effective and compliance dates of the LCRR, which were published in the Federal Register on January 15, 2021, until December 16, 2021 and October 16, 2024, respectively, is not likely to have adverse energy effects. This conclusion is based on the fact that delaying the regulatory requirements of the LCRR will reduce near term demand for energy commodities that would be required to install and operate corrosion control equipment, remove LSLs, or produce and deliver public education materials.

This rulemaking does not involve technical standards.

EPA believes that it is not feasible to determine whether this action has disproportionately high and adverse effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994).

The purpose of this rule is to extend effective date of the LCRR to December 16, 2021, to allow EPA to conduct a review of the LCRR, under Executive Order 13990, and consult with stakeholders, including those who have been historically underserved by, or subject to discrimination in, Federal policies and programs prior to the LCRR going into effect. Because EPA is still in the collection process of potentially significant environmental justice information on the distributional impacts of drinking water lead-related regulatory requirements, it is not feasible to determine with certainty the impact of the delay of the effective and compliance dates of the LCRR.

This action is subject to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act or CRA), and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. The Office of Information and Regulatory Affairs has determined that this action is not a “major rule” as defined by 5 U.S.C. 804(2).

For the reasons stated in the preamble, the Environmental Protection Agency amends 40 CFR part 141 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(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0073 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 August 16, 2021. 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-2016-0073, 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 August 24, 2018 (83 FR 42818) (FRL-9982-37), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 8F8690) by LAM International Corporation, 117 South Parkmont St., Butte, MT 59701. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Purpureocillium lilacinum strain PL11 in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner LAM International Corporation, which is available in the docket via http://www.regulations.gov. One comment was received on the notice of filing. EPA's response to this comment is discussed in Unit III.C.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in making a safety determination to establish an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance exemption 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. . . .” Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] residues and other substances that have a common mechanism of toxicity.”

EPA evaluated the available toxicity and exposure data on Purpureocillium lilacinum strain PL11 and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on that data can be found within the May 20, 2021, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Safety Determination for Purpureocillium lilacinum strain PL11.” This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES .

The available data demonstrated that, with regard to humans, Purpureocillium lilacinum strain PL11 is not toxic, pathogenic, or infective via any reasonably foreseeable route of exposure. Although there may be dietary and non-occupational exposure to residues when Purpureocillium lilacinum strain PL11 is used on food commodities, there is not a concern due to the lack of potential for adverse effects. EPA also determined that retention of the Food Quality Protection Act safety factor for infants and children under FFDCA 408(b)(2)(C) was not necessary as part of the qualitative assessment conducted for Purpureocillium lilacinum strain PL11.

Based upon its evaluation, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Purpureocillium lilacinum strain PL11. Therefore, an exemption from the requirement of a tolerance is established for residues of Purpureocillium lilacinum strain PL11 in or on all food commodities when used in accordance with label directions and good agricultural practices.

An analytical method for enforcement purposes is not required because EPA has determined that reasonably foreseeable exposure to residues of Purpureocillium lilacinum strain PL11 from use of the pesticide will be safe, due to lack of toxicity, pathogenicity, and infectivity. Under those circumstances, it is unnecessary to have an analytical method to monitor for residues.

One comment was received in response to the notice of filing. The comment discusses concerns regarding the use of “GRAS” (generally recognized as safe) determinations to support decisions regarding pesticide products and promotes a complete review of data. Consistent with FFDCA section 408(b)(2)(D), EPA reviews the available scientific data and other relevant information and considers their validity, completeness, and reliability, as well as the relationship of this information to human risk. EPA also considers available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. EPA relied on a variety of data and information to make a risk determination on Purpureocillium lilacinum strain PL11. For more information on the human health risk assessment of Purpureocillium lilacinum strain PL11, please see the supporting documentation provided in the associated regulatory docket (search for “EPA-HQ-OPP-2016-0079” at www.regulations.gov ).

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

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance exemption in this action, 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. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 EPA's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

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

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

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-2020-0067 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 August 16, 2021. 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-2020-0067, 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 https://www.epa.gov/dockets/where-send-comments-epa-dockets. 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 8, 2020 (85 FR 27346) (FRL-10008-38), 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 9E8807) by the Interregional Project Number 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.675 be amended by establishing a tolerance for residues of the insecticide tolfenpyrad, (4-choro-3-ethyl-1-methyl-N-[[4-(4-methylphenoxy)phenyl]methyl]-1H-pyrazole-5-carboxamide), in or on artichoke, globe at 5 parts per million (ppm). That document referenced a summary of the petition prepared by IR-4, the petitioner, which is available in the docket for this action, Docket ID EPA-HQ-OPP-2020-0067, at http://www.regulations.gov. There were no comments received in response to the notice of filing.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

The toxicology database is considered complete. A variety of toxic effects were noted in the toxicology database for tolfenpyrad. However, the most consistent findings across species and studies were effects on bodyweight and bodyweight gain. Decreases in bodyweight and/or bodyweight gain were observed in adults of all species (rat, mice, rabbit, and dog) in the majority of the subchronic oral and dermal toxicity studies, and all chronic toxicity studies. Bodyweight decreases in rats were observed at much lower doses than in other species. Chronic exposure resulted in bodyweight and bodyweight gain decreases in mice and dogs at lower doses than the effects that were observed from acute and subchronic exposures. In addition, quantitative susceptibility was observed in the database; in the rat developmental study, decreased fetal weights and number of ossified metacarpals were observed in the absence of adverse maternal toxicity and in the one-generation reproduction study, decreased pup weights were observed at a lower dose than the dose at which parental bodyweight decreases reached biological significance. Tolfenpyrad is classified as “not likely to be carcinogenic to humans”.

A complete discussion of the toxicological profile for tolfenpyrad as well as specific information on the studies received and the nature of the adverse effects caused by tolfenpyrad as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found in the document titled “Tolfenpyrad—Human Health Risk Assessment of the New Use on Globe Artichoke” (hereinafter “Tolfenpyrad Human Health Risk Assessment”) in docket ID number EPA-HQ-OPP-2020-0067 at https://regulations.gov.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (PODs) 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for tolfenpyrad used for human risk assessment can be found in the Tolfenpyrad Human Health Risk Assessment.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to tolfenpyrad, EPA considered exposure under the petitioned-for tolerances as well as all existing tolfenpyrad tolerances in 40 CFR 180.675. EPA assessed dietary exposures from tolfenpyrad in food as follows:

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

Such effects were identified for tolfenpyrad. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, the acute assessment assumed tolerance-level residues and 100% crop treated (PCT) for all commodities. Refinements include a factor to account for the reduction in residues when wrapper leaves are removed from head lettuce, radicchio, cabbage, Chinese Napa cabbage, and Brussels sprouts. Empirical processing factors were available for processed commodities of apple, orange, cottonseed, grape, plum, potato and tomato, and were translated to other crop processed commodities where appropriate. Where empirical processing factors were not available or were not translated, the Agency's 2018 default processing factors were used. Several factors were used to account for metabolite residues in/on bulb onion subgroup 3-07A commodities and livestock commodities.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the food consumption data from the USDA's 2003-2008 NHANES/WWEIA. As to residue levels in food, EPA used average residues from field trials. The chronic assessment includes estimates of PCT for some crops and all the refinements described above for the acute assessment.

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

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

Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.

• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition c: Data are available on pesticide use and food consumption in a particular area, and the exposure estimate does not understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The acute assessment assumes 100 PCT. The Agency incorporated estimates of average PCT in the chronic assessment for the following crops: Grapefruit (15%), grapes (2.5%), lettuce (10%), onion (2.5%), oranges (5%), peppers (less than 2.5%), potatoes (2.5%), tangerines (2.5%), and tomatoes (2.5%).

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and California Department of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the chemical/crop combination for the most recent 10 years. EPA uses an average PCT for chronic dietary risk analysis and a maximum PCT for acute dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than 1% or less than 2.5%. In those cases, the Agency would use less than 1% or less than 2.5% as the average PCT value, respectively. The maximum PCT figure is the highest observed maximum value reported within the most recent 10 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except where the maximum PCT is less than 2.5%, in which case, the Agency uses less than 2.5% as the maximum PCT.

The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which tolfenpyrad may be applied in a particular area.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for tolfenpyrad in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of tolfenpyrad. 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.

Residues of tolfenpyrad in surface and ground water were modeled with the Pesticide in Water Calculator (PWC Version 1.52). Groundwater estimated drinking water concentrations were modeled with the Pesticide Root Zone Model Groundwater (PRZM GW) model within the Pesticide in Water Calculator (Version 1.52). For tolfenpyrad, the assessment uses the total residues approach, which is commonly used to assess chemicals that have residues of concern with similar toxicity to parent compound. The recommended estimated drinking water concentrations (EDWCs) for tolfenpyrad acute exposures are estimated to be 32.6 parts per billion (ppb) for surface water and 168 ppb for ground water. For chronic exposures for non-cancer assessments, EDWCs are estimated to be 14.1 ppb for surface water and 125 ppb for ground water. For the acute dietary exposure assessment, EPA used an EDWC of 168 ppm. For the chronic dietary exposure assessment, EPA used a value of 125 ppb.

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

Tolfenpyrad is not registered for any specific use patterns that would result in residential exposure. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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 tolfenpyrad and any other substances, and tolfenpyrad does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that tolfenpyrad has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework.

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

2. Prenatal and postnatal sensitivity. There is no evidence of increased quantitative or qualitative susceptibility in the guideline rabbit developmental studies, the rat two-generation reproduction study, or the developmental immunotoxicity (DIT) study. Quantitative susceptibility was observed in the developmental rat study and the range-finding one-generation reproduction study. In the developmental rat study, decreased fetal weights and number of ossified metacarpals were observed in the absence of adverse maternal toxicity (only a 9% decrease in bodyweight). In the one-generation reproduction study, decreased pup weights were observed at a dose lower than the dose at which parental bodyweight decreases reached biological significance. All of the reviewed studies (developmental toxicity studies in the rat and rabbit and the one- and two-generation reproductive toxicity studies in the rat) include decreased bodyweight in the maternal LOAEL statement, as well as mortality in both of the developmental rabbit studies and the two-generation rat reproduction study. Reproductive toxicity was seen in rats as increased total litter loss in the two-generation study and decreased pup viability in the one- and two-generation study. Decreased pup weight was observed in all six studies, and additional offspring effects include: An increase in skeletal variation in both developmental toxicity studies; blackish abdominal cavity, dark green intestinal contents, and decreased survival of offspring in the developmental immunotoxicity study; decreased pup viability in both reproduction studies, with the addition of a delay in developmental landmarks in the two-generation reproductive toxicity study. Since most of these effects occurred in the presence of comparable or more severe maternal toxicity, or were partially attributable to the maternal animal behavior, they were not considered evidence of qualitative susceptibility.

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 tolfenpyrad is complete and includes acceptable developmental and reproductive toxicity studies.

ii. Based on the available toxicity database, there is no indication that tolfenpyrad is a neurotoxic chemical, and there is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity.

iii. While there was evidence of quantitative susceptibility in two studies, the Agency's degree of concern for the susceptibility is low because the offspring effects consistently occurred at or near doses which caused maternal toxicity (bodyweight decrease), and because endpoints and doses selected for risk assessment are protective of the observed susceptibility.

iv. There are no residual uncertainties identified in the exposure databases. The dietary exposure assessment is partially refined but does not underestimate potential dietary exposure to tolfenpyrad. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to tolfenpyrad in drinking water. These assessments will not underestimate the exposure and risks posed by tolfenpyrad.

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 tolfenpyrad will occupy 69% of the aPAD for children 1 to 2 years of age, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to tolfenpyrad from food and water will utilize 59% of the cPAD for all infants less than 1-year old, the population group receiving the greatest exposure. There are no residential uses for tolfenpyrad.

3. Short-term and Intermediate-term risks. Short-term and intermediate-term aggregate exposures take into account short-term and intermediate-term residential exposures plus chronic exposures to food and water (considered to be a background exposure level).

Short-term and intermediate-term adverse effects were identified; however, tolfenpyrad is not registered for any use patterns that would result in short-term or intermediate-term residential exposures. Short-term and intermediate-term risks are assessed based on short-term and intermediate-term residential exposures plus chronic dietary exposure. Because there are no short-term or intermediate-term residential exposures and chronic dietary exposures have already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term and intermediate-term risk), no further assessments of short-term and intermediate-term risks are necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term and intermediate-term risks for tolfenpyrad.

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, tolfenpyrad is not expected to pose a cancer risk to humans.

5. 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 tolfenpyrad residues.

An acceptable high-performance liquid chromatography method with tandem mass spectrometry detection (LC/MS/MS) is available for enforcement of tolfenpyrad residue tolerances in/on plant commodities (Morse Laboratories Analytical Method #Meth-183, Revision #2). For livestock, a method described in PTRL West Study No. 1841W is available. Residues are determined by LC/MS/MS analysis.

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 has not established an MRL for tolfenpyrad in globe artichoke.

Therefore, a tolerance is established for residues of tolfenpyrad, (4-choro-3-ethyl-1-methyl-N-[[4-(4-methylphenoxy)phenyl]methyl]-1H-pyrazole-5-carboxamide), in or on artichoke, globe at 5 ppm.

This action establishes a tolerance under FFDCA section 408(d) in response to petitions 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 to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

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

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

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

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

The proposed rule was published at 86 FR 16686 on March 31, 2021. The Licensee filed comments in support of the petition reaffirming its commitment to apply for channel 22. No other comments were filed. The Licensee states that VHF channels have certain propagation characteristics which may cause reception issues for some viewers and that the reception of VHF signals requires larger antennas generally not well suited to the mobile applications expected under flexible use, relative to UHF channels. In addition, KHQA-TV has received numerous complaints from viewers unable to receive the Station's over-the-air signal, despite being able to receive signals from other stations. Moreover, there would be no loss of service because the noise limited contour of the proposed channel 22 facility completely encompasses the licensed channel 7 facility's noise limited contour.

This is a synopsis of the Commission's Report and Order, MB Docket No. 21-71; RM-11887; DA 21-601, adopted May 21, 2021, and released May 21, 2021. The full text of this document is available for download at https://www.fcc.gov/edocs. To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4). Provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to this proceeding.

The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:

Why we need to publish a rule. Under the Act, if a species is determined to no longer be an endangered or threatened species, we may reclassify the species or remove it from the Federal Lists of Endangered and Threatened Wildlife and Plants due to recovery. A species is an “endangered species” for purposes of the Act if it is in danger of extinction throughout all or a significant portion of its range and is a “threatened species” if it is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act does not define the term “foreseeable future.” However, we consider “foreseeable future” as that period of time within which a reasonable prediction can be relied upon in making a determination about the future conservation status of a species. Water howellia is listed as threatened. We are removing this species from the Federal List of Endangered and Threatened Plants ( i.e., “delist” this species) because we have determined that it is not likely to become an endangered species now or within the foreseeable future. Delisting a species can only be completed by issuing a rule.

The basis for our action. Under the Act, we can determine that a species is an endangered or threatened species based on any one or more of the following five factors or the cumulative effects thereof: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. Based on an assessment of the best available information regarding the status of and threats to water howellia, we have determined that the species no longer meets the definition of an endangered or threatened species under the Act.

This final rule recognizes that based on the best available science, water howellia has reached recovery. Collaborative conservation efforts including increased surveys, land transfers, and land management plans have all aided in the discovery of additional occurrences of the species and provided for long-term protection of the species.

On October 7, 2019, we proposed to remove water howellia from the Federal List of Endangered and Threatened Plants ( i.e., to “delist” the species) (84 FR 53380). For previous Federal actions occurring before October 7, 2019, please see the Previous Federal Actions section of the proposed rule.

In this final rule, we discuss only those topics directly related to delisting water howellia. For more information on the description, biology, ecology, and habitat of water howellia, please refer to the final listing rule published in the Federal Register on July 14, 1994 (59 FR 35860); the most recent 5-year review for water howellia completed in August of 2013 (USFWS 2013, entire); the draft recovery plan for water howellia, completed in September 1996 (USFWS 1996, entire); and the proposed delisting rule published in the Federal Register on October 7, 2019 (84 FR 53380). These documents are available as supporting materials on http://www.regulations.gov under Docket No. FWS-R6-ES-2018-0045. We use concepts of resiliency, redundancy, and representation (Smith et al. 2018) in considering the species' viability. Resiliency is the ability of the species to maintain healthy populations that can withstand annual environmental variation and stochastic events. Redundancy is the ability of the species to maintain an adequate number and distribution of populations that can withstand catastrophic events. Representation is the ability of the species to adapt to changing environmental conditions through genetic, ecological, demographic, and behavioral diversity across its range.

Water howellia was first collected in 1879, along the Columbia River in Multnomah County, Oregon (Gray 1880, entire), and is native to the northwestern United States. The taxonomy of water howellia as a full species in a monotypic genus is widely accepted as valid by the scientific community (The Plant List 2013, unpaginated; ITIS 2017).

Water howellia is an annual, aquatic herb in the bellflower family (Campanulaceae). The entire plant is smooth, possessing no hairs or projections. The stems are fragile, submerged and floating, reaching up to 39 inches (in) (100 centimeters (cm)) in length. Stems branch several inches from the base, and each branch extends to the water surface. The numerous leaves are narrow and range from 1-2 in (25-50 millimeters (mm)) long.

Water howellia produce two types of flowers: Cleistogamous (closed) and chasmogamous (showy, open for pollination). Small cleistogamous flowers are produced along the stem below the water surface and are self-fertilizing. Chasmogamous flowers are produced on the water surface and commonly self-pollinate (Lesica et al. 1988, p. 276; Shelly and Moseley 1988, pp. 5-6).

Suitable water howellia habitat typically includes small, vernal freshwater wetlands and ponds with an annual cycle of filling with water in spring and drying up in summer or autumn (USFWS 1996, p. 14). These habitats can be glacial potholes or depressions (Shapley and Lesica 1997, p. 8; U.S. Department of Defense (USDOD) 2017a, p. 1) or river oxbows (Lesica 1997, p. 366) in Montana and western Washington, riverine meander scars (Idaho NHP 2017, p. 1; Wiechmann 2014a, p. 3) in Idaho, glacial-flood remnant wetlands (Robison 2007, p. 8) in eastern Washington, or landslide depressions (Johnson 2013, pers. comm.) in California, but are all ephemeral (transitory) to some degree. Depending on annual patterns of temperature and precipitation, the drying of the ponds may be complete or partial by autumn; these sites are usually shallow and less than 3 feet (ft) (1 meter (m)) in depth. Some ponds supporting water howellia are dependent on complex ground and surface water interactions. Snow melt runoff is important in maintaining suitable conditions in the spring, while localized groundwater flow mitigates water loss from evaporation and plant transpiration later in the summer (Reeves and Woessner 2004, pp. 7-9).

The drying of water howellia habitat in late summer and autumn is important because water howellia seeds only germinate when exposed to air (Lesica 1990). Upon air exposure, seeds either germinate in the fall and produce seedlings that overwinter under snowcover, or germinate the following spring, with seeds lying on top of the soil through winter. Water howellia seedlings that overwinter in soil resume growth in spring in northern climates (Mincemoyer 2005, p. 3) or begin growing after fall germination in southern climates ( e.g., California) (Johnson 2013, pers. comm.). Spring growth in California and low-elevation occurrences in western Washington typically commence in early April, and in eastern Washington, Idaho, and Montana by early May. Rangewide, emergent (chasmogamous) flowers bloom soon after the stems reach the water surface and are typically present from May through July. Seed dispersal starts in June from submerged (cleistogamous) flowers and extends until late summer from emergent flowers (Shelly and Moseley 1988, p. 5).

Decreased germination rates have been documented for seeds residing in the soil longer than 8 months (Lesica 1992, pp. 415-416). However, monitoring data and observations from Montana (U.S. Forest Service (USFS) 2002, pp. 6-7; USFWS 1996, pp. 17-18) and Washington (Gilbert 2008, pers. comm.) show the presence of water howellia after 2 consecutive years with no plant observations, suggesting seeds may remain viable for at least 3 years. This life-history strategy likely provides a buffer against unfavorable growing conditions in consecutive years.

Composition and depth of substrates in vernal wetlands are also important characteristics of suitable water howellia habitat. Substrates composed of both coarse organic and mineral sediments are correlated with presence of water howellia (Lesica 1992, p. 417). Similarly, water howellia growth in a laboratory setting was highest in coarse organic substrate (Lesica 1992, p. 416). However, mean depth of the organic sediment layer was significantly less in ponds with water howellia, relative to depth in ponds without water howellia (Lesica 1992, p. 417). These results indicate a moderate amount of organic sediment (with some mineral soil) in wetland substrates may be optimum for water howellia presence and growth.

Water howellia occupies habitats across its range that vary in the extent of canopy cover, suggesting some flexibility to potential effects of disturbance on canopy cover. Many water howellia occurrences are surrounded or nearly surrounded by forested vegetation (Mincemoyer 2005, p. 7), with numerous observations reporting water howellia occupying shaded portions of ponds and wetlands (Isle 1997, p. 32; McCarten et al. 1998, p. 4). Conversely, on the Joint Base Lewis-McChord (JBLM) military base in Washington, occupied ponds were historically surrounded by prairie vegetation and, as a result of years of fire suppression, are now surrounded by forest (Gilbert 2017, pers. comm.). Currently, water howellia is occurring in portions of ponds that receive the most light and least shade (Gilbert 2017, pers. comm.). In Montana's Swan Valley, water howellia was present in 78 percent of sites with prior disturbance (roads, fire, grazing, and/or vegetation treatments) of vegetation surrounding the ponds (Pipp 2017, p. 6), indicating some plasticity to the effects of disturbance on extent of canopy cover.

The distribution of water howellia before European settlement and modern development in the Pacific Northwest is unknown. However, after European settlement, water howellia is known from the Pacific Northwest, with historical occurrences documented in California, Oregon, Washington, Idaho, and Montana (Shelly and Moseley 1988, pp. 6, 9). The species still occurs in all five States. Since listing in 1994, new occurrences of water howellia have been documented in all five States, generally in areas within these States known historically to support the species.

At the time of Federal listing (1994), 107 water howellia occurrences were known across the species' range (59 FR 35860; July 14, 1994). In 2020, a minimum of 307 occurrences were documented (see Table 1, below). The majority of extant occurrences (91 percent) are within three metapopulations occupying distinct geographic areas in Montana's Swan Valley (Lake and Missoula Counties); Department of Defense property at JBLM, Pierce County in western Washington; and Turnbull National Wildlife Refuge (Turnbull Refuge), Spokane County in northeastern Washington (see the figure, below). The three metapopulations have enabled the species to remain viable across its range (Freckleton and Watkinson 2002, p. 419). Small, isolated occurrences that are not part of a metapopulation can be more vulnerable to extirpation (Lesica 1992, p. 420). Consequently, identification of these metapopulations is important for directing conservation efforts toward the regional availability of suitable habitat (Freckleton and Watkinson 2002, p. 432). Currently, 258 of the 307 (84 percent) reported water howellia occurrences are on lands administered by the Federal Government. There are 37 reported occurrences of water howellia on private property; however, little is known about them, as limited monitoring of these occurrences has taken place over the years. Two occurrences of water howellia are on State land and the remaining occurrences exist in areas with several jurisdictions ( i.e., straddle public and private lands).

Population trends for water howellia are difficult to determine. Substantial numbers of new occurrences have been discovered since listing in 1994, and, most recently, occurrences have been documented in Oregon, where the species was thought to be extirpated. However, this may not necessarily indicate a positive population trend. Rather, this could indicate increased efficiency at finding new occurrences. Consistent, standardized monitoring has not occurred across the range of the species, making it difficult to document trends, even when repeat monitoring has occurred at occupied sites (Fertig 2019, pp. 40-45). Additionally, an occurrence is broadly defined, and abundance of individual water howellia plants within occurrences fluctuates widely. This is due, in part, to environmental conditions of the preceding autumn, which affect seed germination rates. Nevertheless, based on the discovery of many new occurrences and few recent extirpations of existing occurrences, distribution of the species appears to be currently stable.

Genetic variation among water howellia occurrences is low. Occurrences in California and Montana are genetically similar; however, occurrences in Idaho and Washington are more distantly related (Schierenbeck and Phipps 2010, p. 5). These data suggest that gene flow is occurring between occurrences separated by large geographic distances, albeit at a relatively low rate. A correlation between migratory waterfowl routes with either genetic similarity or distance indicates that waterfowl may be transporting seed or plant material between water howellia population areas (Schierenbeck and Phipps 2010, pp. 6-7). A more robust sampling and genetic analysis of water howellia occurrences across the species' range would be necessary to support or refute this hypothesis.

A recovery plan for water howellia was drafted in 1996, but never finalized (USFWS 1996, entire). Despite having not been finalized, the draft recovery plan constitutes the best available information on what objective, measurable criteria should be met in order to delist the species. Here, we provide a summary of progress made on the draft recovery criteria for water howellia. More detailed information related to conservation efforts can be found below under Summary of Factors Affecting the Species.

1. Recovery criterion: Management practices, in accordance with habitat management plans, have reduced and/or controlled anthropogenic threats, thereby maintaining the species and its habitat integrity throughout the currently known range on public lands in five geographic areas for 10 years after the effective date of the final recovery plan (when finalized). Monitoring will demonstrate the effectiveness of management plans. Management plans will be in place for, at a minimum, the occurrences listed in the following table:

Progress: Despite the recovery plan not being finalized, management plans are in place on Federal lands for the minimum number of occurrences identified in Table 2, above.

Monitoring indicates management plans have been effective at maintaining the minimum number of occurrences by reducing or eliminating anthropogenic threats associated with land management activities ( e.g., timber harvest, road construction, and maintenance) and other threats ( e.g., invasive species). Prior to formalized management plans, some conservation efforts were occurring on Federal, State, and some private land. In addition, survey efforts have documented substantially more occurrences of water howellia rangewide than were known at the time of listing (Mincemoyer 2005, pp. 4-5; Frymire 2017, pers. comm.; Gilbert 2017, pers. comm.; Johnson 2017, pers. comm.; Lichthardt and Pekas 2017, p. 1; ORBIC 2017, unpaginated; Rule 2017, pers. comm.).

2. Recovery criterion: Foster or promote the conservation of occurrences on lands not addressed by agency management plans. Specifically, this recovery criterion recommends long-term conservation measures for the occurrence in Latah County, Idaho.

Progress: Long-term conservation measures for water howellia have been established through land transfers, conservation easements, and management plans on some private lands. In Montana's Swan Valley, large-scale land transfers (67,000 acres (ac) (27,000 hectares (ha)) for the benefit of many species have occurred, and land supporting known water howellia occurrences has been transferred from private to Federal ownership. These occurrences are now protected under Federal agency management plans and conservation strategies. One occurrence located on private land in Latah County, Idaho, is protected under a conservation agreement, held in perpetuity by the Palouse Land Trust. In the 5-year review (USFWS 2013, p. 6), it was noted that, in addition to the conservation agreement, a management plan for this occurrence was being developed (Trujillo 2017, pers. comm.). However, recent communications with Palouse Land Trust indicate that a management plan still needs to be developed for this occurrence (Englund 2020, pers. comm.). Two other occurrences of water howellia on the Coeur d'Alene Reservation in Idaho are being actively managed under the direction of a tribal water howellia management plan (Green 2018, pp. 3-9). The Coeur d'Alene tribe is planning to use active stream/wetland and floodplain restoration, riparian buffering, and outplanting to conserve existing water howellia occurrences and expand the distribution of the species into nearby potentially suitable habitat (Green 2018, entire). The Service is unaware of any information regarding additional efforts to protect water howellia occurrences on private land in other parts of the species' range.

3. Recovery criterion: A post-delisting strategy for monitoring the species' population dynamics is in place.

Progress: We have developed a post-delisting monitoring plan in cooperation with State, Federal, Tribal, and nongovernmental conservation partners. The final post-delisting monitoring plan is available for public review on http://www.regulations.gov under Docket No. FWS-R6-ES-2018-0045.

Additionally, the 5-year review recommended development of a memorandum of understanding (MOU) with the USFS and U.S. Department of Defense (USDOD) to ensure the continuation of existing conservation measures currently benefitting water howellia. Although a formal MOU has not been developed, both agencies have specific conservation strategies in place for the conservation of water howellia (for specific conservation strategies, see discussion of land management effects under A. The Present or Threatened Destruction, Modification, or Curtailment of Its Habitat or Range, below).

Based on public comments on our October 7, 2019, proposed rule (84 FR 53380) and information provided to us by peer reviewers, we made updates or provided additional clarity on information concerning population monitoring vs. surveying, predicted effects of invasive species, regulatory mechanisms, climate change, wetland/pond hydrology, genetic diversity, cumulative effects, post-delisting monitoring, and metapopulation structure. We also made other minor editorial clarifications and corrections in this final rule.

Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for listing species, reclassifying species, or removing species from listed status. “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)). The Act defines an “endangered species” as a species that is “in danger of extinction throughout all or a significant portion of its range,” and a “threatened species” as a species that is “likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” The Act requires that we determine whether any species is an “endangered species” or a “threatened species” because of any of the following factors:

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

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

(C) disease or predation;

(D) the inadequacy of existing regulatory mechanisms; or

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

We must consider these same five factors in delisting a species. For species that are already listed as endangered or threatened species, this analysis of threats is an evaluation of both the threats currently facing the species and the threats that are reasonably likely to affect the species in the foreseeable future following the removal of the Act's protections. According to 50 CFR 424.11(e), we may delist a species if our status review of the best available scientific and commercial data indicates that the species is neither endangered nor threatened for the following reasons: (1) The species is extinct; (2) the species does not meet the definition of an endangered species or a threatened species ( e.g., due to recovery); or (3) the listed entity does not meet the statutory definition of a species.

Water howellia is currently listed as threatened. Section 3(20) of the Act defines 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. The Act does not define the term “foreseeable future.” Our implementing regulations at 50 CFR 424.11(d) set forth a framework for evaluating the foreseeable future on a case-by-case basis. The term “foreseeable future” extends only so far into the future as we can reasonably determine that both the future threats and the species' responses to those threats are likely. In other words, the foreseeable future is the period of time in which we can make reliable predictions. “Reliable” does not mean “certain”; it means sufficient to provide a reasonable degree of confidence in the prediction. Thus, a prediction is reliable if it is reasonable to depend on it when making decisions.

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

For water howellia, we consider 30 years to be a reasonable period of time within which reliable predictions can be made for the species. This time period includes multiple generations of water howellia. Additionally, various global climate models and emission scenarios provide consistent predictions within that timeframe (IPCC 2014, p. 11). We consider 30 years a relatively conservative timeframe in view of the long-term protections in place for 84 percent of the species' occupied habitat occurring on Federal land.

A recovered species has had threats removed or reduced to the point that it no longer meets the Act's definition of an “endangered species” or a “threatened species.” A species is an “endangered species” for purposes of the Act if it is in danger of extinction throughout all or a significant portion of its range and is a “threatened species” if it is likely to become endangered within the foreseeable future throughout all or a significant portion of its range. For the purposes of this analysis, we will evaluate whether or not the currently listed species, water howellia, should continue to be listed as threatened, based on the best scientific and commercial information available.

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

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

The following analysis examines the factors currently affecting water howellia or that are likely to affect it within the foreseeable future.

At the time of listing (59 FR 35860; July 14, 1994), the following potential habitat-based threats were identified for this species: (1) Invasive species, (2) land management (primarily timber harvest and road building), (3) trampling by domestic livestock, (4) direct habitat loss from urbanization or dam construction, and (5) the narrow ecological requirements of the species. In the analysis that follows, we also considered climate change in the context of the species' narrow ecological requirements.

In the final listing rule (59 FR 35860; July 14, 1994), invasive plant species were identified as a threat to water howellia in habitats where they overlap. Invasive species, such as reed canarygrass ( Phalaris arundinacea ), sweet flag ( Acorus calamus ), and yellow flag iris ( Iris pseudacorus ), were identified to have the capacity to outcompete water howellia, presumably for nutrients and space (Lesica 1997, p. 367; Clegg et al. 2000, p. 13; Lichthardt and Pekas 2017, entire). These invasive species may have the potential to extirpate water howellia occurrences (59 FR 35860; July 14, 1994), and as a result, we focus our analysis on these species. The best available information does not indicate any potentially significant negative impacts to water howellia from any other invasive species.

Reed canarygrass is present in water howellia habitat in all States, except California (Johnson 2017, pers. comm.), but the extent of invasion varies by site (Gilbert 2017, pers. comm.; Rule 2017, pers. comm.; Shelly 2017, pers. comm.; Lesica 1997, pp. 367-368). Abundance of reed canarygrass in ponds occupied by water howellia on the Turnbull National Wildlife Refuge (NWR) has fluctuated through time, with no definitive long-term trend (Rule 2017, pers. comm.; Rule 2020, in progress). Abundance of reed canarygrass in ponds occupied by water howellia on the JBLM has also fluctuated through time, with no definitive long-term trend (Gilbert 2017, pers. comm.; Gilbert 2020, pers. comm.). In Montana, reed canarygrass is present in many ponds occupied by water howellia, but increased distribution has not been detected recently (Shelly et al. 2016, entire; Shelly 2017, pers. comm.). However, reed canarygrass invaded Swan River Oxbow Preserve in the Swan Valley in Montana, and water howellia was subsequently extirpated at that site (Lesica 1997, pp. 367-368; Lesica 2001, p. 2). In Idaho, monitoring efforts have not detected any decreases in pond size, which may act as a surrogate for reed canarygrass colonization; however, detailed monitoring of the species has not been conducted (Lichthardt and Pekas 2017, p. 6). Little is known about the extent of reed canarygrass invasion with regard to water howellia occurrences in Oregon.

The mechanisms driving the invasive potential of reed canarygrass within water howellia habitats are unclear. The invasive potential may be due to some sites being occupied by a native genotype of reed canarygrass and other sites being occupied by a highly invasive variety (Casler et al. 2009, entire; Lichthardt and Pekas 2017, p. 8; Wiechmann 2014a, p. 31; Jakubowski et al. 2013, entire; Merigliano and Lesica 1998, entire). Density of reed canarygrass is a better determinant of impact to water howellia occurrences than presence alone (Wiechmann 2014a, pp. 31, 34, 38). Additionally, in some ponds, reed canarygrass was found to be dominant at shallower water depths and water howellia dominant at deeper depths (Wiechmann 2014a, p. 32).

Success of mechanical and chemical treatment efforts to decrease the abundance and distribution of reed canarygrass have varied across the range of water howellia. In California, mechanical treatment has limited the spread of reed canarygrass in ponds and wetlands adjacent to water howellia occurrences, and chemical treatment is further reducing the size of reed canarygrass patches (Johnson 2011, 2017, pers. comm.). Similarly, consistent suppression of reed canarygrass at JBLM (military base) in Washington has reduced patch sizes of the plant in the past (TNC 2006, p. 65; Engler 2008, pers. comm.; Gilbert 2008, pers. comm.). Currently, no suppression efforts are underway at JBLM, due to little change in reed canarygrass distribution and the risk of harming water howellia plants in the process (Gilbert 2017, pers. comm.). In Idaho, the success of suppression efforts to limit abundance and distribution of reed canarygrass were mixed (Lichthardt and Gray 2010, p. 9). However, once suppression efforts were stopped, distribution and abundance of reed canarygrass appeared to vary more with fluctuating environmental conditions than with the presence of suppression effort (Lichthardt and Gray 2010, p. 9). No suppression efforts to control or eradicate reed canarygrass on the Turnbull NWR in Washington are currently underway; the species is present, but trends indicate variability in abundance with fluctuating environmental conditions (Rule 2009, 2013a, 2017, pers. comm.). In Montana, suppression efforts of reed canarygrass have been somewhat successful in some areas (Annen 2010, entire; Healy 2015 and references therein, entire) and not successful in other areas (Lesica and Martin 2004, entire; Lesica 2001, entire).

Sweet flag was identified by the State of Idaho as an invasive species that may be displacing water howellia at one location (Idaho Department of Fish and Game (IDFG) 2016, p. 3). Monitoring at this location has been ongoing since 1999, and water howellia has not been observed since 2001 (Lichthardt and Pekas 2017, p. 2). However, we are unaware of any other water howellia occurrences being affected by sweet flag. As a result, sweet flag is unlikely to become a threat to water howellia.

Yellow flag iris is an invasive plant that has been identified in ponds occupied by water howellia on JBLM in Washington. While it appears yellow flag iris may have the ability to displace or outcompete water howellia in some environments, the infestations on JBLM occur in relatively small areas, and their spread has been controlled by herbicides or mechanical removal (Clegg et al. 2000, p. 13; Gilbert 2019, pers. comm.).

Invasive plants can be aggressive and quickly displace native plants in some situations. While there are some small sites that may have been completely or partially overtaken by invasive plants, water howellia metapopulations appear to maintain viability in the face of invasive species. This conclusion is reinforced by reed canarygrass coexisting with extant water howellia occurrences; large-scale displacement of water howellia by reed canarygrass is not occurring in any of the metapopulations (Swan Valley, Montana; Turnbull NWR and JBLM, Washington), even in the absence of suppression efforts. Given the absence of displacement of water howellia by reed canarygrass within the three metapopulations of water howellia, and the success of existing suppression efforts where they have been applied, we do not consider reed canarygrass to be a significant threat to water howellia. The best available information does not indicate that any other invasive species likely pose a threat to water howellia.

Land management activities that cause disturbance to vegetation surrounding water howellia occurrences were identified as a threat to the species in the final listing rule (59 FR 35860; July 14, 1994). Previous modeling efforts suggested that these activities, singularly or in combination, could result in a loss of vegetation at the pond fringe, disrupting the hydrological cycle and negatively impacting the phenology of water howellia (Reeves and Woessner 2004, pp. 10, 15). However, more recent evidence indicates that effects from land management activities are no longer a threat to the species.

Most land management activities that could disturb vegetation surrounding water howellia occurrences on USFS land are now prohibited or designed to minimize impacts to water howellia. For example, land management activities on the Flathead National Forest in Montana must create a favorable physical environment that protects against hydrological changes that may adversely impact water howellia (USDA 2018, pp. 45-46). These desired conditions and guidelines were incorporated as part of the revised Flathead National Forest Plan in 2018. On the Mendocino National Forest in California, activities that could disturb vegetation within 300 ft (91 m) of water howellia occurrences are typically not allowed because of standards and guidelines to protect the plant (USFS 1995, p. IV-32; Johnson 2013, pers. comm.). Limited activities (including prescribed fire) may be allowed within the 300-ft (91-m) buffer, but only if needed to maintain the integrity of the buffer (USDA 2018, pp. 18-23, 44-46; Johnson 2013, pers. comm.). The 2018 revised Flathead National Forest Plan in Montana has also incorporated the conservation strategy for water howellia, which was finalized in 1997 (USFS 1997, entire; for a more in-depth discussion of land management plans, see Existing Regulatory Mechanisms, below). As a result of these actions, abundance and distribution of water howellia have remained stable in Montana's Swan Valley from 1978 to 2014 (Pipp 2017, p. 14).

On State land in Montana, clear-cutting of timber and prescribed fire are prohibited within defined buffers surrounding waterbodies (Montana Code Annotated 2019, title 77, chapter 5, part 3, at 77-5-303). In Washington, buffer zones are established in wetlands containing water howellia on Turnbull NWR when mechanical thinning and prescribed fire are used to treat conifer encroachment (Rule 2009, pers. comm.). Timber harvest and prescribed fire were not identified as potential threats to other water howellia occurrences in Washington (USDOD 2006, entire; USDOD 2012, entire; USDOD 2017a, entire; Anderson 2013, pers. comm.; Gilbert 2013, 2017, pers. comm.), or occurrences in Oregon or Idaho (Currin 2013, pers. comm.; USFWS 2009, entire; IDFG 2016, entire).

Some disturbance of vegetation surrounding water howellia occurrences from land management activities occurred historically, prior to existing guidelines and standards in Federal land management plans. For example, in Montana's Swan Valley, historical disturbances caused from land management activities ( e.g., timber harvest, timber thinning, prescribed fire, road building, grazing) have occurred in vegetated buffers surrounding many of the existing water howellia occurrences (Pipp 2017, p. 6). However, 79 percent of existing water howellia occurrences in the Swan Valley have experienced at least one historical disturbance event in the surrounding vegetation and are still viable, indicating some tolerance of water howellia to buffer disturbance. In addition, abundance or distribution of water howellia in the Swan Valley has remained stable, despite these historical disturbances from land management activities (Pipp 2017, p. 14). Furthermore, despite experiencing a stand-replacing fire in 2003, water howellia occurrences in the affected area of the Swan Valley are stable; buffer vegetation appears to have recovered, and hydrology is adequately functioning (Pipp 2017, pp. 14-15).

The effects of historical road building within vegetated buffers surrounding water howellia occurrences have largely been mitigated on Federal and State lands. Guidance established in the revised Flathead National Forest Plan indicates that maintenance on roads within 300 ft (92 m) of ponds providing habitat for water howellia should maintain or improve hydrological integrity to protect habitat conditions (USDA 2018, pp. 45-46). No effects of historical roads occurring within vegetated buffers on water howellia in the Swan Valley were found in a recent analysis (Pipp 2017, p. 16). Similarly, in California, small spur roads are being closed and hydrologically stabilized in areas occupied by water howellia on the Mendocino National Forest to minimize anthropogenic contribution to landscape instability per direction in the Mendocino National Forest Plan (USFS 1995, p. III-26; Johnson 2008, pers. comm.). These conservation measures appear to be working in California, as six of the seven known occurrences of water howellia are still viable. In Idaho, the Idaho Transportation Department (ITD) avoids adverse effects to wetlands during project implementation, and a Best Management Practices Manual identifies measures to minimize any potential effects during project implementation (ITD 2014, entire; ITD 2017, p. 1). The State of Idaho identified two water howellia occurrences within 98 ft (30 m) of an established highway and expressed concern about indirect effects of road work resulting in sedimentation and, of less concern, potential removal of shade (IDFG 2016, p. 4). However, the best available information does not indicate any potential effects that road work may pose to this population. Roads were not cited as a threat to water howellia occurrences in Washington or Oregon (USDOD 2006, entire; USDOD 2012, entire; USDOD 2017a, entire; USFWS 2007, entire; USFWS 2010; entire; Anderson 2013, pers. comm.; Currin 2013, pers. comm.).

Land management activities ( e.g., timber harvest, timber thinning, road building, grazing, and prescribed fire) that disturb vegetation surrounding water howellia occurrences were once considered a threat to the species. However, most land management activities that have the potential to disturb surrounding vegetation are prohibited by land management plans or other Federal or State policy. Some of these prohibitions were put in place as a result of the species being listed, but will remain in effect for the duration of the land management plan or other policy, even when the species is delisted. Where disturbance of vegetation from land management activities has occurred, water howellia has shown some tolerance for disturbance and no downward trend in presence or distribution. Given that all three metapopulations currently have conservation measures in place to avoid vegetative buffer disturbance from land management activities and that water howellia has shown some tolerance to disturbance when it occurs, we no longer consider land management activities to be a significant threat to water howellia.

Trampling of water howellia by domestic livestock was cited as a threat in the final listing rule for the species (59 FR 35860; July 14, 1994). Direct effects of plant crushing, seed bank disturbance, and alterations to substrate are likely to occur when livestock enter and exit ponds and wetlands. In addition, increased nutrient loading may be an indirect effect of livestock occupancy in and near water howellia habitat. Some water howellia occurrences are within habitats actively used by livestock. However, the level of livestock-caused disturbance that water howellia can withstand is not known and likely varies with site-specific conditions, as well as timing, severity, and duration of livestock use of occupied water howellia habitat.

The effects of trampling on water howellia occurrences on Federal and State land have largely been mitigated by fencing, cattle barricades, elimination of grazing in some areas occupied by water howellia, or limitations on the duration of time livestock have access to sensitive pond and wetland habitats (USFS 2002, p. 6; Mincemoyer 2005, p. 11; Johnson 2008, 2013, pers. comm.; Frymire 2017, pers. comm.). In Montana, analyses of monitoring data spanning nearly 30 years have concluded that despite some grazing in occupied habitat, the presence of water howellia has not been affected (Pipp 2017, p. 17).

Although no causal link was made between grazing levels and the probability of water howellia presence in the Pipp (2017) analysis, it appears that management actions such as fencing, cattle guards, and exclusion implemented concurrently with grazing have provided protections to water howellia habitat and allowed the species to be conserved in Montana's Swan Valley (Pipp 2017, p. 17). In California, specific grazing regimes near five occupied ponds within an active grazing allotment on National Forest land appear to be effective; monitoring indicates no effects to water howellia occurrences from livestock trampling (Johnson 2013, pers. comm.). Two other water howellia occurrences in California are within inactive grazing allotments, where livestock are not currently present and not expected to be present in the future (Johnson 2013, 2017, pers. comm.). Trampling is not reported as a threat in Washington, Idaho, or Oregon (USDOD 2006, entire; USDOD 2017a, entire; USFWS 2007, entire; USFWS 2010, entire; Currin 2013, pers. comm.; IDFG 2016, entire). It is unknown where grazing may occur on the 37 occurrences (12 percent of total known occurrences) on private property. Therefore, the extent of trampling and other livestock-related alterations to water howellia habitat on these private lands is unknown. However, potential trampling effects from livestock on Federal and State land have been largely mitigated.

Trampling of water howellia by domestic livestock is not a threat to the species on Federal or State land at current grazing levels because of mitigation measures being implemented, including riparian fencing, cattle guards, and timely removal or relocation of livestock from sensitive pond and wetland habitats. The best available information does not indicate that levels of livestock use (and thus potential trampling) will increase beyond current levels in the future. The severity and frequency of trampling of water howellia occurrences on private land are unknown, but as significantly fewer water howellia occurrences are known from private lands, any impacts are likely not significant at the species level and have not affected recovery, which has been achieved based on species viability on State and Federal lands. We conclude, based on the available information, that trampling by domestic livestock is not a significant threat to water howellia.

Habitat loss from urbanization and dam construction occurred historically, particularly in Oregon, and was considered a threat to water howellia at the time of listing in 1994. However, additional habitat loss from urbanization and dam construction is no longer a threat to the species because conservation strategies implemented following listing and increased Federal ownership now provide additional protections (see Conservation Efforts, above).

Direct habitat loss from urbanization and dam construction occurred along the Columbia River in Oregon, and water howellia was thought to be extirpated from that area prior to 2015 (USFWS 2017, entire; Norman 2010, pers. comm.). However, since then, two occurrences of water howellia have been located in the Portland, Oregon, metro area (ORBIC 2017, unpaginated).

Most of the water howellia occurrences on corporate or private lands in Montana were previously owned by Plum Creek Timber. In 2007, approximately 67,000 ac (27,000 ha) of Plum Creek land in the Swan Valley were sold to The Nature Conservancy (TNC) and Trust for Public Land; ownership was then transferred to either the USFS or the State of Montana (Swan Valley Connections 2017, entire). The 47 water howellia occurrences and potential habitat that were formerly on Plum Creek land are now protected from urbanization through either the Flathead National Forest Plan (USFS 1997, entire) or State agency direction for managing timberlands (DNRC 1996, p. 1). The Flathead National Forest Plan mandates avoidance of disturbance, including urbanization, in forested buffers of a minimum of 300 ft (91 m) from water howellia occurrences. The State of Montana manages its timberlands for long-term revenue and biodiversity (DNRC 1996, p. 2) and not for short-term revenue from selling timbered State lands and the potential urbanization that may follow.

It is unknown if historical habitat loss occurred in California; however, most known occurrences of water howellia are within USFS lands, including some within designated wilderness areas (Johnson 2013, pers. comm.). Therefore, no current or future threat of habitat loss from urbanization is expected because any disturbance of vegetated buffers surrounding water howellia ponds is prohibited under the Mendocino National Forest Plan unless it is necessary to promote natural ecological and hydrological function (USFS 1995, pp. IV-19, 35). It is unknown how urbanization has affected the 37 water howellia occurrences on private land, but because there are significantly fewer occurrences known from private lands (12 percent of total known occurrences), these impacts are likely not significant at the species' level.

In sum, habitat loss from urbanization and dam construction occurred historically, particularly in Oregon, but is no longer considered a significant threat. In Oregon, recent new discoveries of water howellia indicate that the species has been able to remain extant on the landscape where it was once considered extirpated. In areas surrounding the extant, larger metapopulations, habitat loss from urbanization and dam construction is not considered a threat to the species because of conservation strategies and land transfers implemented in Montana (USFS) and Washington (USDOD and the Service). Furthermore, known habitat in California is largely within USFS lands, including designated wilderness; thus, there is no significant threat of habitat loss from urbanization or dam construction in California.

Based on the final listing rule (59 FR 35860; July 14, 1994), the following stressors warranted consideration as possible current or future threats to water howellia: Invasive species, land management activities, trampling by domestic livestock, and direct habitat loss from urbanization or dam construction. However, as described below, these stressors have not occurred to the extent determined or anticipated at the time of listing in 1994, or the stressors are being adequately managed, or the species is more tolerant of the stressor than was previously thought.

• Land management plans and conservation management strategies have been adopted by Federal and State agencies to mitigate the effects of land management activities on water howellia and are in place for all three metapopulations. These plans vary in duration, but are longer term (15+ years) and are expected to continue to provide protections to water howellia habitat into the future because the plans (and all future revisions to the plans) are mandated by Federal laws to conserve fish, wildlife, and plant species. For a more in-depth discussion of land management plans and relevant Federal laws, see Existing Regulatory Mechanisms, below.

• Suppression efforts directed at reed canarygrass have resulted in some success. Furthermore, water howellia occurrences are not currently being displaced by reed canarygrass, and the best available data do not indicate that they are being displaced by other invasive species.

• The installation of riparian fencing and cattle barricades and the implementation of specific grazing routines have effectively mitigated the effects of trampling on water howellia.

• The extant metapopulations, as well as most occurrences in California, are largely managed by Federal agencies that have conservation strategies in place. Therefore, neither urbanization nor dam construction is a threat to water howellia.

• Limited information is available regarding the 37 occurrences (12 percent of known occurrences) that occur on private property. Due to the low number of occurrences on private land relative to Federal and State land, impacts to water howellia on private lands are likely not significant at the species level.

Therefore, based on the available information, we do not consider there to be any significant habitat-based threats for water howellia.

Overutilization, for any purpose, was not considered a threat in the final rule to list water howellia (59 FR 35860; July 14, 1994). The best available information does not indicate any current use of water howellia for commercial, recreational, scientific, or educational purposes. Regarding future utilization, interest has been expressed by the Valencia Wetland Mitigation Bank in Priest River, Idaho, to collect seed via soil plugs from vigorous water howellia occurrences for use in establishing new occurrences where appropriate habitat exists (Wiechmann 2014b, entire). Initially, a harvest of 5 to 7 soil plugs from other Idaho occurrences has been proposed. The proposed project would be beneficial if it created another occurrence of water howellia in northern Idaho or had educational value. Recent communications with Valencia Wetland Mitigation Bank indicate that they are still interested in pursuing this project (Collier 2020, pers. comm.). We are not aware of any other current or future plans for use of the species. Therefore, based on the available information, we find that there are no significant threats to water howellia related to overutilization for commercial, recreational, scientific, or educational purposes.

Predation (herbivory) on water howellia by domestic livestock was considered a threat in the final rule to list the species (59 FR 35860; July 14, 1994). As described in more detail above, grazing is limited within the species' habitat, and the occurrence of water howellia in ponds accessible to livestock in the Swan Valley metapopulation has not been affected (Pipp 2017, p. 17). As a result, we conclude that predation does not affect the species throughout its range at the population or species level. The best available information does not indicate that levels of livestock grazing will increase within known occurrences of water howellia in the future. The best available information also does not indicate any issues or potential stressors regarding disease or insect predation. Therefore, based on the available information, we do not consider there to be any significant threats to water howellia from disease or predation.

In this section, we discuss: (1) The narrow ecological requirements of the species in the context of climate change, (2) small population size/low genetic diversity, and (3) the potential for cumulative effects of stressors.

Here, we consider the narrow ecological requirements of water howellia in the context of observed or projected changes in climate. The July 14, 1994, listing rule (59 FR 35860) did not discuss the potential impacts of climate change on water howellia. The terms “climate” and “climate change” are defined by the Intergovernmental Panel on Climate Change (IPCC). The term “climate” refers to the mean and variability of relevant quantities ( i.e., temperature, precipitation, wind) over time (IPCC 2014, pp. 119-120). The term “climate change” thus refers to a change in the mean or variability of one or more measures of climate ( e.g., temperature or precipitation) that persists for an extended period, typically decades or longer, whether the change is due to internal processes or anthropogenic changes (IPCC 2014, p. 120).

Global climate projections are informative, and in some cases, the only or the best scientific information available for us to use. However, projected changes in climate and related impacts can vary substantially across and within different regions of the world ( e.g., IPCC 2013c, 2014, entire) and within the United States (Melillo et al. 2014, entire). Therefore, we use “downscaled” projections when they are available and have been developed through appropriate scientific procedures, because such projections provide higher resolution information that is more relevant to spatial scales used for analyses of a given species (see Glick et al. 2011, pp. 58-61, for a discussion of downscaling).

Climate change trends predicted for the Pacific Northwest (Oregon, Washington, Idaho, and Montana) broadly consist of an increase in annual average temperature; an increase in extreme precipitation events; and, with less certainty, variability in annual precipitation (Dalton et al. 2013, pp. 31-38, Figure 1.1; Snover et al. 2013, pp. 5-1-5-4). Lee et al. (2015) describe potential hydrological changes in response to predicted climate change on montane wetlands in the Pacific Northwest. These observations appear to vary with local conditions and include earlier drawdown, more rapid drying out in the summer, and reduced minimum water levels.

Yearly weather patterns influence abundance of water howellia. Abundance of water howellia is typically lower if the preceding season had higher precipitation and/or cooler summer temperatures (Shelly et al. 2016, entire). This decrease is likely due to limited pond drying, which negatively affects seed germination rates due to their need for air exposure to germinate. Conversely, abundance of water howellia is typically higher if the preceding season had lower precipitation and/or hotter summer temperatures (Shelly et al. 2016, entire), due to more pond drying and increased rates of seed germination.

There is uncertainty regarding how the predicted trends in precipitation and air temperature due to climate change in the Pacific Northwest will influence water howellia. In western Montana, where all the known statewide occurrences of water howellia occur, regional climate data predict (1) increasing average annual air temperatures and (2) precipitation increasing in winter, spring, and fall and decreasing in summer (Montana 2017, pp. 40-63). These predicted conditions are similar to those observed to increase water howellia abundance ( e.g., increased pond drying with annual recharge in the winter, spring) in Montana historically. Thus, future climate conditions may be favorable, on average, for water howellia. In Washington, predicted increases in air temperature and more rapid drying of montane wetlands could be favorable to water howellia, assuming adequate recharge in the winter and spring (Shelly et al. 2016, entire). The effects of predicted increased variability in precipitation on water howellia remains unclear. A potential increase in precipitation as a result of climate change may affect the species in several ways. First, increases in precipitation may increase the surface area of existing ponds and wetlands, or create new ones. These new habitats would be available for colonization by water howellia and could increase the range and resiliency of the species. However, new habitats would also be available to invasive species such as reed canarygrass and may also promote their expansion on the landscape. An important factor in increased habitat would likely be the site-specific conditions within each habitat; new habitat with deeper water and longer periods of inundation would likely preclude the establishment of reed canarygrass and be beneficial to water howellia. Conversely, the creation of shallower habitat may favor reed canarygrass. Another possible effect of increased precipitation may be the alteration of the hydrologic cycle of water howellia habitats. Specifically, these habitats may fill earlier (with heavier spring rainfall) and dry later in the season than they did historically, thereby reducing the timing window for air exposure needed for seed germination of water howellia in late summer and autumn.

Alternatively, a potential decrease in precipitation as a result of climate change also may affect water howellia in several ways. Decreases in precipitation may result in water levels that are too low to support the submergent flower production. Additionally, earlier drawdowns and the faster receding of water in these wetlands as a result of decreased precipitation may ultimately limit the continued persistence of ephemeral ponds. This could provide an opportunity for expansion of reed canarygrass and other invasive species. On the other hand, amplified drying may allow for increased germination and expansion of water howellia. Another scenario with decreased precipitation is that the hydrological cycles could be altered in a way that would favor water howellia. Ponds that were previously perennial could potentially become ephemeral in nature, providing the wetting and drying cycle necessary for water howellia reproduction and, consequently, additional habitat for the species to occupy. Again, the site-specific conditions for each habitat would be an important factor.

Changes in precipitation from snow to rain may also affect water howellia, particularly in the southernmost occurrences ( e.g., California) (California DWR 2013, p. 22). More precipitation falling as rain rather than snow would likely alter the hydrologic cycle within these habitats. These alterations could include faster drying of wetlands than was observed historically, due to a lack of spring run-off from snow fields and increased annual air temperature. More frequent extreme precipitation events are predicted for California (California DWR 2013, p. 23). The effect of more extreme precipitation events on water howellia habitat in California is unclear, especially given the potential for interactions among precipitation and other environmental variables predicted to change ( e.g., reduced snowpack, increased annual air temperature).

The ability of water howellia to self-fertilize and produce seeds at both the early season submergent and later season emergent forms may be an advantage to surviving lengthened, shortened, or generally more inconsistent growing seasons than occurred historically. Seed production from both flower forms in one growing season may increase the opportunity for surviving subsequent inclement years. It is uncertain how increases in water temperature and increased evaporation due to increased ambient temperatures would affect growth and reproduction of water howellia; however, climate conditions that restrict the dual seed production and seed banking could reduce the ability of water howellia to sustain populations over time.

Associated wetland vegetation that positively contributes to suitable microclimates for water howellia could be altered by predicted variance in temperatures and precipitation; the effects of which are uncertain. Occurrences of water howellia in Montana and eastern Washington could be more resilient to these processes than other occurrences because of their distribution over a larger landscape with many separate occurrences. Increasing temperatures combined with increased demand for ground and surface water for human development may compound negative impacts to water howellia in eastern Washington and northern Idaho. Climate-induced effects on water howellia may appear first in California, as these occurrences are at the southern edge of the known range. However, these effects may be buffered by the higher elevation (approximately 3,800 ft (1,158 m)) at which the California occurrences are found compared to elsewhere in the range (western Washington: approximately 15 ft (5 m)).

Predicted environmental changes resulting from climate change may have both positive and negative effects on water howellia, depending on the extent and type of impact and depending on site-specific conditions within each habitat type (Lee et al. 2015, p. 14). The primary predicted negative effect is the alteration of hydrologic regimes (Lee et al. 2015, p. 14) potentially resulting in inconsistent growing seasons. This effect will likely be buffered by the ability of water howellia to produce seeds during both early and late seasons. Predicted environmental effects that may be positive for water howellia include increased habitat, seed dispersal, and species distribution in some areas, including within the three metapopulations due to predicted increases in precipitation across the northern range of the species (IPCC 2014, p. 61). The intact nature and current spatial arrangement (geographically diverse and at varying elevations) of the three large metapopulations will likely provide more resilience to climate change than the smaller, isolated occurrences. Effects of potential composition shifts in vegetation surrounding water howellia occurrences as a result of climate change are unknown.

In summary, climate change is affecting and will continue to affect temperature and precipitation events. The extent, duration, and impact of those changes are unknown, but could potentially increase or decrease precipitation in some areas. Water howellia may experience climate change-related effects in the future, most likely at the individual or local population level. Regional occurrences may experience some shifts. However, it is anticipated that the metapopulations important to the viability of the species would continue to be viable because of resiliency due to geographic and elevational diversity rangewide and because some of the future predicted air temperature and precipitation conditions are similar to the yearly weather conditions that promote larger abundances of water howellia (lower precipitation and/or hotter summer temperatures). Available information indicates that increased variability in future climate conditions is likely, but that water howellia has some plasticity to environmental change as evidenced by the species' viability despite a changing climate and its life-history strategy of dual seed production and longer-term seed viability to buffer against several consecutive years of unfavorable environmental conditions. Therefore, based upon the best available information, we conclude that climate change is not a significant threat to water howellia.

The final rule to list water howellia (59 FR 35860; July 14, 1994) cited small population size ( i.e., limited extent of occupied habitat) as a contributor to its vulnerability. Species that occupy limited amounts of habitat often have reduced viability because they may lack resiliency to recover from stochastic events. Water howellia currently occupies about 400 acres of habitat rangewide, comprised of 307 occurrences with most occurrences occupying less than 1 acre. While most of the occurrences of water howellia are small in areal extent, the arrangement of occupied habitat across 5 States is advantageous to water howellia because increased redundancy and representation increase the capacity of water howellia to survive a catastrophic event. Stochastic events still may affect individual occurrences, but the widespread arrangement of the occurrences increases redundancy and representation. Further, long-term monitoring has shown that water howellia are more tolerant of natural stochasticity or manmade disturbance in buffer areas surrounding occupied ponds than previously thought (Pipp 2017, p. 6). In addition, the documentation of 200 additional occurrences of water howellia since 1994 has increased the redundancy and representation of habitats for water howellia rangewide. This increased redundancy and representation of habitats increases the viability of water howellia, relative to 1994, because of an increased buffer against stochastic and catastrophic events.

The final rule to list water howellia (59 FR 35860; July 14, 1994) cited lack of genetic variation within and among occurrences as a contributor to its vulnerability. Low genetic diversity could limit a species' or population's ability to respond to novel changes in its environment, necessitating redundancy of occurrences across larger areas to increase the probability of survival. At the time of listing in 1994, the only genetic investigation of the species showed very low genetic diversity within and among occurrences in Washington and Montana (Lesica et al. 1988, p. 278). More current genetic results indicate greater genetic diversity within and among occurrences than previously thought; however, diversity is still relatively low (Brunsfeld and Baldwin 1998, p. 2; Schierenbeck and Phipps 2010, p. 5). Another genetic investigation documented that all occurrences are distantly related and that gene flow is likely occurring between the States (Schierenbeck and Phipps 2010, p. 6). However, it is also possible that these results indicate that infrequent, long-distance dispersal events (likely facilitated by waterfowl) do occur, but actual gene flow is not occurring or rarely occurring.

The effects of low genetic diversity of water howellia on adaptability to future climate conditions are unknown. Water howellia is a self-pollinating species; thus, genetic diversity is expected to be lower, in general, than that for cross-pollinating species (Hamrick and Godt 1996, entire). Water howellia populations have remained stable despite rapidly changing air temperatures since the late 1990s (Snover et al. 2013, p. ES-3); however, it is unknown whether future air temperature trajectories will remain similar to those observed from the late 1990s to present. Another consideration is the time scale on which genetic diversity operates. For example, there has been considerable debate about what effective population size is adequate to conserve genetic diversity and long-term adaptive potential (see Jamieson and Allendorf 2012 for review, p. 579). However, loss of genetic diversity is typically not an immediate threat even in isolated populations (Palstra and Ruzzante 2008, p. 3441), but rather is a symptom of deterministic processes acting on the population (Jamieson and Allendorf 2012, p. 580). In other words, loss of genetic diversity typically does not drive species to extinction (Jamieson and Allendorf 2012, entire); other processes, such as habitat degradation, have a more immediate and greater impact on species viability (Jamieson and Allendorf 2012). We acknowledge the documented low genetic diversity of water howellia; however, the best available information indicates that the potential effects from low genetic diversity on water howellia's viability would not occur within the foreseeable future. In addition, the redundancy of smaller occurrences across the species' range may help mitigate for reduced genetic plasticity within individual occurrences because unfavorable environmental conditions affecting one or several occurrences may not affect other occurrences in different parts of the range. The current spatial arrangement of multiple occurrences spread across 5 States is favorable to the species' long-term viability because these occurrences are at different elevations and within varying climatic regimes rangewide (see discussion under “Narrow Ecological Requirements/Climate Change,” above). Thus, we do not consider small population size or low genetic diversity to be a significant threat to water howellia.

Many of the stressors faced by water howellia are interrelated and could work in concert with each other, resulting in a cumulative adverse effect on the species. For example, stressors discussed under Factor A that individually do not rise to the level of a threat could together result in habitat loss. Similarly, small population size in combination with stressors discussed under Factor A could present a potential concern.

Climate change is occurring across the range of the species, coinciding with all other identified stressors. As described previously, variations in climatic conditions may favor or preclude invasive species, depending on site-specific habitat factors. Also described previously, climate change may alter hydrological cycles. However, despite changing climate conditions, water howellia has sustained populations across its range. Analysis of long-term datasets and observations indicate the species has maintained viability even with climate change interacting with other potential stressors (Gilbert 2017, pers. comm.; Rule 2017, pers. comm.; Pipp 2017, entire; Rule 2020, in progress). This indicates that water howellia has some capacity to survive and reproduce, despite potential cumulative effects of climate change and other stressors to date. Nevertheless, we recognize that there are uncertainties associated with future climate change predictions and potential cumulative effects. Ongoing management and monitoring of water howellia (via the post-delisting monitoring plan) is designed to detect potential future changes in the species' distribution and abundance.

There may be locations of water howellia occurrences where invasive species are present, and cattle have access to occupied ponds. Grazing may limit the expansion of invasive species in these instances. Otherwise, we are not aware of particular locations within water howellia occurrences where multiple stressors occur. Also, we do not anticipate stressors to increase on federally managed lands, which afford protection to the species in most of the occupied habitat. Furthermore, the documented new occurrences and greater distribution of the species since it was listed in 1994 provide additional resiliency, redundancy, and representation across the range of the species, which is expected to increase the viability of the species in the face of cumulative threats. Therefore, we conclude, based on the available information, that cumulative effects are not a significant threat to water howellia.

Given the lack of threats within water howellia occurrences and increases in the species' known distribution since listing in 1994, we conclude that climate change, small population size and low genetic diversity, and cumulative effects are not significant threats to water howellia.

We examined the stressors identified within the other factors as ameliorated or exacerbated by any existing regulatory mechanisms or conservation efforts for water howellia. Section 4(b)(1)(A) of the Act requires the Service to take into account those efforts, if any, being made by any State or foreign nation, or any political subdivision of a State or foreign nation, to protect endangered or threatened species. We consider relevant Federal, State, and Tribal laws, regulations, and other such binding legal mechanisms that may ameliorate or exacerbate any of the threats we describe in the threats analysis or otherwise enhance the conservation of the species. We give the strongest weight to statutes and their implementing regulations and to management direction that stems from those laws and regulations; an example is State governmental actions enforced under a State statute or constitution or Federal action under the statute.

For currently listed species, we consider the adequacy of existing regulatory mechanisms to address threats to the species absent the protections of the Act. Therefore, we examine whether other regulatory mechanisms would remain in place if the species were delisted, and the extent to which those mechanisms will continue to help ensure that future threats will be reduced or eliminated.

In our previous discussion of threats, we evaluate the significance of threats as mitigated by any conservation efforts and existing regulatory mechanisms. Where threats exist, we analyze the extent to which conservation measures and existing regulatory mechanisms address the specific threats to the species. Regulatory mechanisms, if they exist, may reduce or eliminate the impacts from one or more identified threats.

Although inadequacy of existing regulatory mechanisms was not specifically identified as a threat to water howellia at the time of listing in 1994, we did mention the very limited number of protections that existed for the species (59 FR 35860, July 14, 1994, see p. 59 FR 35862). Specifically, we discussed the designation of water howellia as a sensitive species by the USFS and referred to wetland protection measures provided under section 404 of the Federal Clean Water Act (33 U.S.C. 1251 et seq. ), title XII of the Food Security Act of 1985 (16 U.S.C. 3801 et seq. ), and some State laws.

Clean Water Act: The Clean Water Act (CWA) was designed, in part, to protect surface waters of the United States from unregulated pollution from point sources. The CWA provides some benefit to water howellia through the regulation of discharge into surface waters through a permitting process; however, the historical threats to water howellia habitat have not typically been associated with point sources of pollution, and current information does not point to these as threats for occurrences today.

Under section 404 of the CWA, the U.S. Army Corps of Engineers (USACE) regulates the discharge of fill material into waters of the United States, including wetlands. In general, the term “wetland” refers to areas meeting the USACE's criteria of hydric soils, hydrology (either sufficient annual flooding or water on the soil surface), and hydrophytic vegetation (plants specifically adapted for growing in wetlands). Some habitat occupied by water howellia is considered isolated waters under the CWA. As a result of various Supreme Court decisions, the CWA's jurisdiction over isolated waters has been uncertain and generally determined case-by-case. Further, Federal agencies are currently considering removing isolated waters from CWA jurisdiction (82 FR 34899; July 27, 2017). Thus, the extent of water howellia receiving the protections of the CWA now and in the future is uncertain. However, the protections of the CWA to water howellia habitat that is under CWA jurisdiction are expected to remain when the species is delisted and the protections of the Act removed.

Food Security Act: The Food Security Act was designed, in part, to protect wetlands by removing incentives for farmers to convert wetlands into crop fields. The Food Security Act likely provides some indirect protection of potential water howellia habitats on private land, but not those on Federal or State land. Although there are no data directly linking the Food Security Act and water howellia, historically, it has been demonstrated that the Food Security Act has had positive impacts on wetland function (Gleason et al. 2011, p. S65). Although the future of the Food Security Act in its current form is uncertain, any protections afforded to wetlands would confer benefit to water howellia should the species be present.

National Environmental Policy Act: Environmental review of potential effects of Federal actions is mandated under the National Environmental Policy Act (NEPA; 42 U.S.C. 4321 et seq. ). When NEPA analysis reveals significant environmental effects, the Federal agencies must disclose those effects to the public and consider mitigation that could offset the effects. These mitigations usually provide some protections for listed species. However, the NEPA does not require that adverse impacts be mitigated, only disclosed. Therefore, because NEPA is procedural, it does not independently provide protection for the species.

National Forest Management Act: Federal activities on USFS lands are subject to the National Forest Management Act of 1976 (NFMA; 16 U.S.C. 1600 et seq. ). The NFMA requires the development and implementation of resource management plans that guide the maintenance of ecological conditions that support natural distributions and abundance of species and not contribute to their extirpation.

In 2018, the Flathead National Forest in Montana revised its resource management plan (often called a forest plan), and the Mendocino National Forest in California anticipates revising their forest plan in the near future. The revised Flathead National Forest plan includes measures for conservation of the known water howellia occurrences on USFS land in Montana by incorporating the existing USFS conservation strategy for water howellia into the revised forest plan (USFS 2018, pp. 20, 45-46, 52, 99-100, 143-144; Shelly 2019, pers. comm.; USFS 1997, pp. 17-18). The inclusion of the conservation strategy into the revised forest plan is important, because in addition to providing conservation measures for known water howellia occurrences, it also provides for conservation of ponds that are suitable habitat but are currently unoccupied. Guidance provided in the Mendocino National Forest plan has resulted in the use of buffer strips to protect riparian species and function surrounding ponds occupied by water howellia in California. Both the Flathead National Forest plan and Mendocino National Forest plan are expected to continue to be implemented when water howellia is delisted, based on discussions with the USFS (see Conservation Efforts and Habitat-based Threats, above) and the fact that these plans are longer term (15+ years; NFMA, 16 U.S.C. 1600 et seq. ) forest planning documents. Further, NFMA requires forest plans to provide protection for streams, stream banks, shorelines, lakes, wetlands, and other bodies of water from detrimental changes in water temperatures, blockages of water courses, and deposits of sediment, where tree harvests are likely to seriously and adversely affect water conditions or fish habitat. Thus, any future revisions to the Flathead National Forest or Mendocino National Forest plans would still provide some protections to water howellia and its habitat.

Water howellia is given consideration as a Federal species at risk by Federal agencies under the 2012 National Forest System land management planning rule (77 FR 21162; April 9, 2012). When delisted, water howellia will be evaluated for designation as a species of special concern and designated as such if there is substantial concern for its viability in the plan area. The USFS anticipates that water howellia will be given the status of “species of conservation concern” in both plans when the species is delisted (Shelly 2016, pers. comm.; Johnson 2017, pers. comm.). If water howellia is not given the status of “species of conservation concern” upon delisting, the 2012 planning rule still requires any forest plan to provide for the diversity of plant and animal communities and the long-term persistence of native species in the plan area. Further, the planning rule also requires a forest plan to provide ecological conditions to keep common native species common, contribute to the recovery of endangered and threatened species, conserve candidate species and species proposed for listing, and maintain viable populations of species of conservation concern within the plan area. Thus, any future revisions to the Flathead National Forest or Mendocino National Forest plans will provide some protections to water howellia and its habitat.

Federal Land Policy and Management Act: Similar to NFMA, the Federal Land Policy and Management Act of 1976 (43 U.S.C. 1701 et seq. ) applies to the Bureau of Land Management (BLM) with regard to the conservation and use of public lands under their management. Water howellia is given consideration as a federally listed species by Federal agencies, and when delisted, will likely be included on the sensitive species list for the BLM as it was at the time of listing (59 FR 35860; July 14, 1994). Special status species policies (BLM manual, section 6840, p. 37) detail the need to conserve these species and the ecosystems on which they depend using all methods and procedures which are necessary to improve the condition of special status species and their habitats to a point where their special status recognition is no longer warranted. The one occurrence of water howellia in Washington on BLM land is vulnerable to localized actions. However, application of best management practices (BMPs) consistent with resource management plan (RMP) direction appears to have maintained this occurrence since 1993 (Frymire 2017, pers. comm.). The implementation of BMPs is expected to continue in the absence of protections under the Act.

Sikes Act: Water howellia occurrences and habitats on Federal military installations (JBLM in Pierce County, Washington) are managed under an integrated natural resources management plan (INRMP) (USDOD 2006, pp. 4-6) authorized by the Sikes Act (16 U.S.C. 670a et seq. ). Protections for water howellia habitat in the INRMP include restrictions on motorized equipment and military training activities in wetlands occupied by water howellia. In concert with the INRMP, JBLM has developed an Endangered Species Management Plan for water howellia that establishes conservation goals, management prescriptions, and monitoring efforts (USDOD 2012, entire). These protections are expected to continue when the species is delisted because the Sikes Act mandates USDOD to conserve and rehabilitate wildlife, fish, and game on military reservations.

National Wildlife Refuge System Improvement Act: As directed by the National Wildlife Refuge System Improvement Act (Pub. L. 105-57, 16 U.S.C. 668dd), Refuge managers have the authority and responsibility to protect native ecosystems, fulfill the purposes for which an individual refuge was founded, and implement strategies to achieve the goals and objectives stated in management plans. For example, Turnbull NWR (Spokane County, Washington) includes extensive habitat for water howellia, including 35 known occupied sites. The NWR's comprehensive conservation plan (CCP) is a land management plan with a 15-year term that directs protection of these habitats and identifies specific objectives relative to research and monitoring, invasive species management, and education regarding water howellia (USFWS 2007, p. 2-22). Given the 15-year timeframe of CCPs, unless the CCPs are modified earlier, these protections will remain in place until at least 2022 regardless of water howellia's Federal listing status. After 2022, the Turnbull NWR can revise the CCP, if needed. However, the likelihood of future CCP revisions including conservation of water howellia are high, because the National Wildlife Refuge System Improvement Act mandates conservation of fish, wildlife, and plants, and their habitats within the Refuge System. In addition, the overarching goal of the National Wildlife Refuge System is to manage their lands and waters for the conservation of fish, wildlife, and plant resources and their habitats, further underscoring the high likelihood of future protections for water howellia and its habitat.

In 2010, Ridgefield NWR in western Washington finalized a CCP that includes several conservation strategies for water howellia. These strategies include allowing natural flooding cycles and various methods ( e.g., mechanical, biological, chemical) for invasive species control (USFWS 2010, pp. 2-37, 2-54). Given the 15-year timeframe of CCPs, protections outlined in the Ridgefield NWR CCP for water howellia are expected to remain in place until at least 2025, regardless of water howellia's Federal listing status. After 2025, the Ridgefield NWR can revise the CCP, if needed. However, the likelihood of future CCP revisions including conservation of water howellia are high, because the National Wildlife Refuge System Improvement Act mandates conservation of fish, wildlife, and plants, and their habitats within the Refuge System. In addition, the overarching goal of the National Wildlife Refuge System is to manage their lands and waters for the conservation of fish, wildlife, and plant resources and their habitats, further underscoring the high likelihood of future protections for water howellia and its habitat.

Montana Streamside Management Zone Act: The Montana Streamside Management Zone Act (SMZ), in part, designates vegetated buffer strips around surface waters, including wetlands adjacent to streams (and thus potential water howellia habitat), within the boundaries of timber harvest units in Montana. The SMZ law covers Federal, State, and private commercial timber practices (Montana Code Annotated 2019, title 77, chapter 5, part 3). The SMZ law specifically prohibits slash fill of wetlands, off-road vehicle use, and clear cutting within 50 ft (15 m) of water bodies (Montana Code Annotated 2019, title 77, chapter 5, part 3, at 77-5-303). There are no buffer strips designated for isolated wetlands (those not adjacent to a stream/river) under the SMZ and only voluntary restrictions on equipment travel through isolated wetlands. Although unclear, some water howellia occurrences in Montana's Swan Valley may occur in isolated wetlands. Thus, the direct loss of habitat or plants for a small number of occurrences from timber harvest activities is a possibility if water howellia plants occupy isolated wetlands within a timber harvest unit. However, audits of timber sale practices conducted by interdisciplinary review teams have consistently documented few violations of the SMZ law and generally high (greater than 90 percent) compliance with voluntary regulations in the recent past (Montana DNRC 2016, entire). Thus, while there is potential for water howellia habitat to be lost for occurrences in isolated wetlands, the magnitude of the stressor appears small. As State law, the protections of the SMZ are expected to continue when we delist water howellia.

Washington Natural Heritage Plan: Washington State's Natural Heritage Plan identifies priorities for preserving natural diversity, including wetlands, in Washington State (Washington Department of Natural Resources (DNR) 2007, 2011, entire). The plan aids Washington DNR in conserving key habitats that are currently imperiled or expected to be in the future. The prioritization of conservation efforts provided by this plan is expected to remain in place when we delist water howellia.

Washington Forest Practices Act: Washington State's Forest Practices Act, and associated regulations and rules (Revised Code of Washington, title 76, chapter 76.09; Washington Administrative Code, title 222, chapter 222-08), provides protection of wetlands from the fill and cutting that could result from commercial timber harvest operations. Minimum buffers of 25 ft (8 m) are designated around ponds and wetlands inside timber sale boundaries, effectively prohibiting most harvest and all heavy equipment used in these areas. These buffers protect water howellia habitat from disturbance and minimize impacts to water quality. As State law, these protections are expected to remain in place when we delist water howellia.

Oregon Revised Statutes (ORS), Chapter 564: ORS 564 requires non-Federal public agencies to protect State-listed plant species found on their lands. Any land action on Oregon non-Federal public lands which results, or might result, in the taking of an endangered or threatened species requires consultation with the Oregon Department of Agriculture (ODA) staff. Removal of Federal protections for water howellia will remove State protection of the species under this statute because water howellia was never formally listed by ODA. However, protections are expected to remain in place due to other rare, sensitive plant species in the area inhabited by water howellia and the commitment of the Metro (Portland-area regional government) to protect the only known occurrences of water howellia in Oregon (Currin 2013, pers. comm.).

As discussed above and under the other factors, conservation measures and existing regulatory mechanisms (such as Federal and State land management plans and conservation strategies) have ameliorated, or are continuing to minimize, the previously identified threats of invasive species, land management activities (primarily timber harvest and road building), trampling by domestic livestock, and direct habitat loss from urbanization or dam construction to all three water howellia metapopulations. As indicated above, the majority of these mechanisms will remain in place regardless of the species' Federal listing status. In Montana, the existing conservation strategy for water howellia is now part of the Flathead National Forest Plan; thus, the Montana metapopulation will continue to receive protections regardless of its status under the Act. In Washington on National Wildlife Refuges, there is a high likelihood that any future CCP revisions will include protections for water howellia because the mission of the National Wildlife Refuge System is to manage their lands specifically for conservation of fish, wildlife, and plant resources and their habitats; thus, water howellia and its habitat on Refuge land are expected to be conserved into the future. In Washington on JBLM, an Endangered Species Management Plan specifically speaks to the management of wetlands to benefit water howellia, and the Sikes Act mandates wetland protection, enhancement, and restoration, where necessary for the support of fish, wildlife, or plants, regardless of the species' status under the Act. Thus, all three metapopulations are protected by regulatory mechanisms that have been shown to be effective and are expected to continue to be effective regardless of the species' status under the Act. Consequently, we find that conservation measures, along with existing regulatory mechanisms, are adequate to address these specific stressors.

In the proposed rule published in the Federal Register on October 7, 2019 (84 FR 53380), we requested that all interested parties submit written comments on our proposal to delist water howellia by December 6, 2019. We also contacted appropriate Federal and State agencies, scientific experts and organizations, and other interested parties and invited them to comment on the proposal. Newspaper notices inviting general public comment were published in California (Times Standard in Eureka and Mendocino Beacon in Fort Bragg), Montana (Missoulian in Missoula and Interlake in Kalispell), Oregon (Oregonian in Portland), and Washington (News Tribune in Tacoma and Spokesman Review in Spokane). We did not receive any requests for a public hearing. All substantive information provided during the comment period was either incorporated directly into this final rule or is addressed below.

In accordance with our joint policy on peer review policy published 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 (USFWS 2016, entire), we solicited expert opinion from nine knowledgeable individuals with scientific expertise and familiarity with water howellia, its habitat, its taxonomy, its biological needs and potential threats, or principles of conservation biology. We received responses from three peer reviewers.

We reviewed and addressed all comments we received from the peer reviewers for substantive issues and new information regarding the proposed delisting of water howellia. The peer reviewers provided additional information, clarifications, and suggestions to improve the final rule. All changes suggested by peer reviewers are incorporated into the text of this final rule. Such changes include additional details and/or clarity concerning population monitoring vs. surveying, predicted effects of invasive species, regulatory mechanisms, climate change, wetland/pond hydrology, genetic diversity, cumulative effects, post-delisting monitoring, and metapopulation structure. We also made other minor editorial clarifications and corrections in this final rule based on peer reviewer comments.

We received six letters from the public that provided comments on the proposed rule. Most of these commenters either generally supported or generally opposed the delisting of the species without providing further information.

One commenter opposed our use of 2013 data to support our proposed delisting action; this commenter argues that these data are outdated. We have incorporated updated sources of information (118 instances of using data more recent than 2013), where applicable, in this rule and have not relied solely on data from 2013 (32 instances of using data from 2013, where appropriate). In accordance with section 4(b)(1)(a) of the Act, we use the “best scientific and commercial information available,” regardless of its date, to inform our determinations under section 4(a)(1) of the Act.

Another commenter provided substantive comments, mainly related to the occurrences of water howellia in California. We incorporated the updated information provided by this public commenter into this final rule.

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

We have carefully assessed the best scientific and commercial information available regarding the past, present, and future threats to water howellia, including invasive species (Factor A), land management activities (Factor A), trampling by domestic livestock (Factor A), direct habitat loss from urbanization or dam construction (Factor A), predation (herbivory) by domestic livestock (Factor C), narrow ecological requirements of the species in the context of climate change (Factor E), small population size/low genetic variation (Factor E), and cumulative effects of stressors (Factor E). Based on the best available information, and as described in our threats analysis, above, the identified stressors fall into one or more of the following categories:

• Stressors that have not occurred to the extent anticipated at the time of listing and existing information indicates that this will not change in the future (trampling by domestic livestock, predation (herbivory), direct habitat loss from urbanization or dam construction).

• Stressors that are adequately managed and existing information indicates that this will not change in the future (invasive species, land management activities).

• Stressors for which the species is tolerant and existing information indicates that this will not change in the future (narrow ecological requirements of the species in the context of climate change, small population size/low genetic variation, cumulative effects).

Thus, our analysis of this information indicates that these stressors are not of sufficient imminence, intensity, or magnitude to indicate that water howellia is in danger of extinction or likely to become so within the foreseeable future throughout all of its range. Therefore, after assessing the best available information, we determine that water howellia is not in danger of extinction throughout all of its range nor is it likely to become so in the foreseeable future throughout all of its range.

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

In undertaking this analysis for water howellia, we choose to address the status question first—we consider information pertaining to the geographic distribution of both the species and the threats that the species faces to identify any portions of the range where the species may be endangered or threatened.

For water howellia, we considered whether the threats are geographically concentrated in any portion of the species' range at a biologically meaningful scale. We examined the following threats:

• Invasive species--Invasive species, particularly reed canarygrass, are widely scattered throughout the species' range, with no concentration in any particular area. Furthermore, water howellia metapopulations appear to be able to coexist with invasive species even in the absence of suppression efforts.

• Land management activities--On Federal lands (where 84 percent of water howellia occurrences are), most land management activities that could disturb vegetation surrounding water howellia are now either prohibited or designed to minimize impacts. On State lands, clear-cutting of timber and broadcast burning are either prohibited within defined buffers or not identified as threats. Therefore, adverse practices on Federal and State lands are very infrequent and are not concentrated in any particular area of the species' range.

• Trampling by domestic livestock--Effects of trampling on water howellia occurrences on Federal and State land have largely been mitigated with fencing, cattle barricades, elimination of grazing in some areas occupied by water howellia, or limitations on the duration of time livestock have access to sensitive pond and wetland habitats. Therefore, effects from trampling on Federal and State lands are very infrequent and are not concentrated in any particular area of the species' range.

• Direct habitat loss from urbanization or dam construction--Further habitat loss from urbanization and dam construction is no longer a threat to the species because conservation strategies and increased Federal ownership now provide additional protections. Consequently, direct habitat loss from these activities is minimal and is not concentrated in any particular area of the species' range.

• Predation (herbivory) by domestic livestock--Similar to trampling, the effects from grazing are limited within water howellia habitat, and the species has maintained viability in ponds accessible to livestock. Therefore, its effects on Federal and State lands and are not concentrated in any particular area of the species' range.

• Narrow ecological requirements of the species in the context of climate change--Metapopulations important to the viability of the species are expected to sustain occurrences because of resiliency due to geographic and elevational diversity rangewide. Some of the future predicted air temperature and precipitation conditions are similar to the yearly weather conditions that promote larger abundances of water howellia (lower precipitation and/or hotter summer temperatures). Available information indicates that increased variability in future climate conditions is likely, but water howellia has some plasticity to environmental change as evidenced by its viability despite a changing climate and its life-history strategy of dual seed production and longer-term seed viability to buffer against several consecutive years of unfavorable environmental conditions. Therefore, despite occurring throughout the species' range, the potential effects are minimal and are not concentrated in any particular area of the species' range.

• Small population size/low genetic variation--Most occurrences of water howellia are small in areal extent; however, the arrangement of occupied habitat across five States increases redundancy, representation, and the capacity to survive a catastrophic event. In addition, the documentation of 200 additional occurrences of water howellia since 1994 has increased the redundancy and representation of habitats for water howellia rangewide. Small populations are not concentrated in any particular area of the species' range.

• Cumulative effects--Analysis of long-term datasets indicates the species has maintained viability and has the capacity to survive and reproduce, despite potential cumulative effects of climate change and other stressors. Potential cumulative effects are not concentrated in any particular area of the species' range.

We found no concentration of threats in any portion of the water howellia's range at a biologically meaningful scale. Therefore, no portion of the species' range can provide a basis for determining that the species is in danger of extinction now or likely to become so in the foreseeable future in a significant portion of its range, and we find that the species is not in danger of extinction now or likely to become so in the foreseeable future throughout all of its range. This 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) and Center for Biological Diversity v . Jewell, 248 F. Supp. 3d, 946, 959 (D. Ariz. 2017).

Our review of the best available scientific and commercial information indicates that water howellia does not meet the definition of an endangered species or a threatened species in accordance with sections 3(6) and 3(20) of the Act. Therefore, we are removing water howellia from the List of Endangered and Threatened Plants.

This rule revises 50 CFR 17.12(h) to remove water howellia from the Federal List of Endangered and Threatened Plants. Because no critical habitat was ever designated for this species, this rule does not affect 50 CFR 17.96.

The prohibitions and conservation measures provided by the Act, particularly through sections 7 and 9, will no longer apply to this species. Federal agencies will no longer be required to consult with the Service under section 7 of the Act in the event that activities they authorize, fund, or carry out may affect water howellia.

Section 4(g)(1) of the Act requires us, in cooperation with the States, to implement a monitoring program for not less than 5 years for all species that have been delisted due to recovery. The purpose of this requirement is to develop a program that detects the failure of any delisted species to sustain itself without the protective measures provided by the Act. If at any time during the monitoring period, data indicate that protective status under the Act should be reinstated, we can initiate listing procedures, including, if appropriate, emergency listing.

We are delisting water howellia based on new information we have received as well as conservation actions taken. Since delisting is, in part, due to conservation taken by stakeholders, we have prepared a post-delisting monitoring (PDM) plan for water howellia. The PDM plan was drafted collaboratively with stakeholders and was reviewed by both peer and public reviewers during the comment period for the proposed delisting rule (84 FR 53380; October 7, 2019). The PDM plan discusses the current status of the taxon and describes the methods for monitoring the taxon. The PDM plan: (1) Summarizes the status of water howellia at the time of delisting; (2) describes frequency and duration of monitoring; (3) discusses monitoring methods and sampling regimes; (4) defines what potential triggers will be evaluated to address the need for additional monitoring; (5) outlines reporting requirements and procedures; (6) outlines a schedule for implementing the PDM plan; and (7) defines responsibilities. It is our intent to work with our partners towards maintaining the recovered status of water howellia. The PDM plan is available on the internet at http://www.regulations.gov at Docket No. FWS-R6-ES-2018-0045.

We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), need not be prepared in connection with regulations pursuant to section 4(a) of the 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), E.O. 13175, and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for healthy ecosystems, to acknowledge that Tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to Tribes. We are aware of two water howellia occurrences that occur on Tribal lands; we have notified the Tribes that may be affected by this rule and offered government-to-government consultation.

A complete list of all references cited in this rule is available on the internet at http://www.regulations.gov at Docket No. FWS-R6-ES-2018-0045, or upon request from the Montana Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT ).

The authors of this final rule are staff members of the Montana Ecological Services Field Office and field and regional offices in California, Colorado, Idaho, Oregon, and Washington.

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

Why we need to publish a rule. Under the Act, a species may be delisted ( i.e., removed from the Federal Lists of Endangered and Threatened Wildlife and Plants (Lists)) if it is determined that the species has recovered and no longer meets the definition of an endangered or threatened species. Removing a species from the Lists can only be completed by issuing a rule.

What this document does. This rule removes Lepanthes eltoroensis from the Federal List of Endangered and Threatened Plants, based on its recovery.

The basis for our action. We may delist a species if we determine, after a review of the best scientific and commercial data, that: (1) The species is extinct; (2) the species does not meet the definition of an endangered species or a threatened species; or (3) the listed entity does not meet the statutory definition of a species (50 CFR 424.11(e)). Here, we have determined that the species may be delisted because it no longer meets the definition of an endangered species or a threatened species, as it has recovered.

On March 10, 2020, we published in the Federal Register (85 FR 13844) a proposed rule to remove Lepanthes eltoroensis (no common name) from the Federal List of Endangered and Threatened Plants (List). Please refer to that proposed rule for a detailed description of previous Federal actions concerning this species. The proposed rule and supplemental documents are provided at http://www.regulations.gov under Docket No. FWS-R4-ES-2019-0073.

A team of Service biologists, in consultation with other species experts, prepared a species status assessment (SSA) report for Lepanthes eltoroensis. The SSA report represents a compilation of the best scientific and commercial data available concerning the status of the species, including the impacts of past, present, and future factors (both negative and beneficial) affecting the species. We solicited independent peer review of the SSA report by five individuals with expertise in L. eltoroensis or similar epiphytic ( i.e., a plant that grows on another plant for support but not for food) orchid species' biology or habitat, or climate change. The final SSA, which supports this final rule, was revised, as appropriate, in response to the comments and suggestions received from our peer reviewers. The SSA report and other materials relating to this rule can be found on the Service's Southeast Region website at http://www.regulations.gov under Docket No. FWS-R4-ES-2019-0073.

In preparing this final rule, we reviewed and fully considered all comments we received during the comment period from the peer reviewers and the public on the proposed rule to delist Lepanthes eltoroensis. Minor, nonsubstantive changes and corrections were made throughout the document in response to comments. However, the information we received during the public comment period on the proposed rule did not change our determination that L. eltoroensis no longer meets the definition of endangered or threatened under the Act.

A thorough review of the taxonomy, life history, and ecology of Lepanthes eltoroensis is presented in the SSA report (Service 2019, entire), which is available at http://www.regulations.gov under Docket No. FWS-R4-ES-2019-0073 and summarized in this final rule.

Lepanthes eltoroensis is a member of a large genus of more than 800 orchid species. Approximately 118 species in this genus are from the Caribbean, and all but one are single-island endemics (Stimson 1969, p. 332; Barre and Feldmann 1991, p. 11; Tremblay and Ackerman 1993, p. 339; Luer 2014, p. 260). This species is a small, epiphytic orchid about 1.57 inches (in.) (4 centimeters (cm)) tall and is distinguished from other members of the genus by its obovate to oblanceolate leaves, ciliate sepals, and the length of the inflorescence (Vivaldi et al. 1981, p. 26; Luer 2014, p. 260). The inflorescence is a small (0.03 in.; 0.75 millimeters (mm)), peduncled raceme (flower cluster with flowers on separate short stalks) with reddish flowers. No more than two flowers are produced at the same time, and the flowers are open on the inflorescence for about 10 days (Meléndez-Ackerman and Tremblay 2017, p. 1).

We considere Lepanthes eltoroensis to be a single metapopulation, with the individual trees that host the L. eltoroensis plants as subpopulations, and the host tree aggregates as patches (Service 2019, p. 16). A number of characteristics (see below) indicate that a metapopulation approach may be appropriate to understand orchid population dynamics (see Service 2019, pp. 14-15) and epiphytic species (Snall et al. 2003, p. 567; Snall et al. 2004, p. 758; Snall et al. 2005, pp. 209-210) like L. eltoroensis. Metapopulations are defined as a set of subpopulations with independent local dynamics occupying discrete patches (Hanski 1999, entire; Hanski and Gaggiotti 2004, pp. 3-22) so that simultaneous extinction of all subpopulations is unlikely.

Metapopulations of Lepanthes orchids exhibit high variance in reproductive potential, high variance in mean reproductive lifespan (Tremblay 2000, pp. 264-265), and few adults per subpopulation (Tremblay 1997a, p. 95). Less than 20 percent of individuals reproduce, and most subpopulations (60 percent of host trees) have fewer than 15 individuals. In addition, the distribution of individuals (seedling, juvenile, and adults) varies enormously among subpopulations ( i.e. host trees) and is skewed towards few individuals per tree (Tremblay and Velazquez-Castro 2009, p. 214). The lifespan of L. eltoroensis can reach 30 to 50 years (Tremblay 1996, pp. 88-89, 114). However, the mean is 5.2 years, with an average percent mortality of 10 percent per year, although this varies greatly among life stages. Survival increases as individual orchids reach later life stages, but fewer plants reach adulthood and have the opportunity to contribute offspring to the next generation (Tremblay 2000, p. 265; Rosa-Fuentes and Tremblay 2007, p. 207). Because the species occurs within a protected National Forest, access to moss, dispersal ability, reproductive success, and lifespan influence survivorship more than other potential human-induced threats (Tremblay 2000, p. 265; Rosa-Fuentes and Tremblay 2007, p. 207).

The reproductive success of Lepanthes eltoroensis subpopulations is highly sensitive to temporal variation in environmental conditions (Tremblay and Hutchings 2002, entire). Further, reproductive success of L. eltoroensis, as in most orchids, is pollinator-limited (Tremblay et al. 2005, p. 6). This obligate cross-pollinated species (Tremblay et al. 2006, p. 78) uses a deceptive pollination system (the plants send false signals to the insects, imitating some rewarding conditions), typically characterized by very few reproductive events (~ less than 20 percent chance; Tremblay et al. 2005, p. 12). Although we do not know the pollinator for L. eltoroensis, elsewhere fungus gnats visit Lepanthes orchids (Blanco and Barboza 2005, p. 765) and pollinate by pseudocopulation ( i.e., attempted copulation by a male insect with the orchid flower that resembles the female, carrying pollen to it in the process). Therefore, it is likely fungus gnats are a pollinator for L. eltoroensis. Fungus gnats do not travel far—perhaps tens of meters or even a few hundred meters (Ackerman 2018)—limiting pollen dispersal for L. eltoroensis. Most L. eltoroensis pollination occurs among individuals within a host tree, resulting in high inbreeding and low genetic variability (Tremblay and Ackerman 2001, pp. 55-58). The seeds of L. eltoroensis are wind-dispersed and require a mycorrhizal association for germination and survival until plants start photosynthesis (Tremblay and Ackerman 2001, p. 55; Tremblay 2008, p. 85).

Lepanthes eltoroensis is endemic to EYNF, Puerto Rico. It is restricted to one general area within the Sierra Palm, Palo Colorado, and dwarf forests of the El Toro and Trade Winds trails (Service 2015, p. 5) at elevations above 2,461 feet (750 meters) (Service 1996, p. 2). At the time of listing, the species consisted of an estimated 140 individual plants. Since then, surveys have located additional individuals and subpopulations (groups of L. eltoroensis on the same host tree), resulting in a much greater estimate of individuals than at the time of listing. Surveys for L. eltoroensis have been infrequent, sparse, and done with varying spatial spread and methodology, making the results difficult to compare over time (Service 2019, pp. 34-52). However, partial surveys conducted periodically from 2000 to 2018 have found greater numbers of L. eltoroensis (Service 2019, pp. 49-50). In addition, surveys conducted between 2000 and 2005 indicated the subpopulations surveyed along El Toro Trail and Trade Winds Trail were relatively stable over the 5-year period (Service 2019, p. 39). The best available metapopulation estimate is 3,000 individual plants (Tremblay 2008, p. 90; Service 2015, p. 5). Overall, data do not indicate a general pattern of decline, but rather natural fluctuations (Service 2019, p. 52).

The 3,000 plant population estimate was made prior to category 5 Hurricane Maria making landfall in 2017. A post-hurricane partial survey along the El Toro Trail was completed in 2018, and found 641 total plants, including over 300 that had not been previously identified (Meléndez-Ackerman 2018, pers. comm.). We note that this was only a partial survey; there has never been a complete census of the entire metapopulation because most of the areas off the two main trails (El Toro and Trade Winds) are dangerous and inaccessible.

The forest types Lepanthes eltoroensis is most affiliated with—Palo Colorado, Sierra Palm, and Dwarf Forest—cover over 13,000 acres (5,261 hectares) within the EYNF (Service 2019, p. 8). Given the amount of unreachable habitat that has not been surveyed, all estimates are likely to underestimate the true abundance of the species (Service 2019, p. 50). Surveys of habitat outside traditionally surveyed sites (on or just off trails) could result in discovery of additional plants (Tremblay 2008, p. 90; Service 2019, pp. 18, 50, 73). In addition, since the time of listing, the species has faced multiple strong hurricanes (Hugo, Georges, Hortense, Irma, and Maria), while the species' abundance has remained stable (with all age classes represented and in good health); thus, we conclude the species has the ability to recover from stochastic disturbances (Service 2019, pp. 51-52). Therefore, although the species and its habitat were harmed by the recent hurricanes (namely Maria), the previous estimate of 3,000 individual plants is still our best estimate.

Lepanthes eltoroensis occurs on moss-covered trunks ( i.e., host trees) within upper elevation cloud forests in the Sierra Palm, Palo Colorado, and Dwarf Forest associations of EYNF (Luer 2014, p. 260; Ewel and Whitmore 1973, pp. 41-49), where humidity ranges from 90 to 100 percent, and cloud cover is continuous, particularly during the evening hours (55 FR 41248; October 10, 1990). Important habitat components seem to be elevation, adequate temperature and moisture regimes, open/semi-open gaps in the canopy, and presence of moss.

Section 4(f) of the Act directs us to develop and implement recovery plans for the conservation and survival of endangered and threatened species, unless we determine that such a plan will not promote the conservation of the species. Recovery plans are not regulatory documents. Rather, they are intended to establish goals for long-term conservation of a listed species and 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. Recovery plans also 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 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 we 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 be 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 that was not known at the time the recovery plan was finalized may become available. 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 Lepanthes eltoroensis as well as an analysis of the recovery criteria and goals as they relate to evaluating the status of this orchid. Lepanthes eltoroensis was listed as an endangered species in 1991, due to its rarity (Factor E), its restricted distribution (Factor E), forest management practices (Factor A), impacts from hurricane damage (Factor E), and collection (Factor B) (56 FR 60933, November 29, 1991, p. 56 FR 60935). The most important factor affecting L. eltoroensis at that time was its limited distribution. Additionally, we concluded at the time that the species' rarity made it vulnerable to impacts from hurricanes, such as unfavorable microclimatic conditions resulting from numerous canopy gaps. Because so few individuals were known to occur, the risk of extinction was considered to be extremely high (56 FR 60933, November 29, 1991, p. 56 FR 60935).

The Lepanthes eltoroensis recovery plan was approved on July 15, 1996. The objective of the recovery plan is to provide direction for reversing the decline of this orchid and for restoring the species to a self-sustaining status, thereby permitting eventual removal from the Federal List of Endangered and Threatened Plants (Service 1996, p. 8). However, the recovery plan provides only criteria for reclassifying the species from endangered to threatened (“downlisting”). The specific criteria are: (1) Prepare and implement an agreement between the Service and the USFS concerning the protection of L. eltoroensis within EYNF, and (2) establish new populations capable of self-perpetuation within protected areas (Service 1996, p. 8). The plan also includes the following recovery actions intended to address threats to the species:

(1) Prevent further habitat loss and population decline;

(2) Continue to gather information on the species' distribution and abundance;

(3) Conduct research;

(4) Establish new populations; and

(5) Refine recovery criteria.

The following discussion provides specific details for each of these actions and the extent to which the recovery criteria have been met.

This action has been completed. In the past, the species' primary threat was identified as destruction and modification of habitat associated with forest management practices ( e.g., establishment and maintenance of plantations, selective cutting, trail maintenance, and shelter construction; 56 FR 60933, November 29, 1991). As described below under “Forest Management Practices,” the best available data indicate that forest management practices are no longer negatively affecting Lepanthes eltoroensis. The area where the species is found is within a protected area (EYNF), part of which is the El Toro Wilderness designated in 2005, where the land is managed to preserve its natural conditions and species like L. eltoroensis (USFS 2016, p. 32). We expect this wilderness area will remain permanently protected as a nature reserve and be managed for conservation. Additionally, because this area is within a National Forest, the National Forest Management Act of 1976 (16 U.S.C. 1600 et seq. ) requires the USFS to develop management plans, and EYNF has. As noted below, the EYNF plan specifically includes a set of standards and guidelines to protect the natural resources within the El Toro Wilderness.

Moreover, Federal agencies are mandated to carry out programs for the conservation of endangered species under section 7 of the Act to ensure that any action authorized, funded, or carried out by a Federal agency is not likely to jeopardize the continued existence of a federally listed species. The USFS consults with the Service as necessary to avoid and minimize impacts to listed species and their habitat at EYNF. L. eltoroensis shares habitat with other federally listed species ( e.g., the endangered plants Ilex sintenisii (no common name) and Ternstroemia luquillensis (palo colorado), and the threatened elfin-woods warbler ( Setophaga angelae )), so L. eltoroensis will benefit from efforts to conserve their habitat.

This action has been completed. Since the species was listed in 1991, several surveys for Lepanthes eltoroensis have been conducted. Although these surveys have been done with varying spatial spread and methodology, making the results difficult to compare over time, even partial surveys have found greater numbers of L. eltoroensis. Surveys have indicated stable growth rates. While the best available estimate of the metapopulation is 3,000 individuals (Tremblay 2008, p. 90), surveys likely underestimate the species' true abundance, as suitable habitat off the two main trails is dangerous and mostly inaccessible, preventing additional surveys. Surveys of habitat outside traditional population sites may result in additional individuals.

Much research has been completed; however, we continue to conduct research on the species. Information has been collected throughout the years on the distribution and dispersion patterns of Lepanthes eltoroensis (Tremblay 1997a, pp. 85-96), variance in floral morphology (Tremblay 1997b, pp. 38-45), and genetic differentiation (Tremblay and Ackerman 2001, pp. 47-62). In 2016, the Service and the Puerto Rico Department of Natural and Environmental Resources (PRDNER) provided funding to researchers at the University to evaluate the current population status of L. eltoroensis and model its demographic variation in response to climatic variability ( i.e., temperature and relative humidity). This research suggests that L. eltoroensis population growth rates are highly dynamic depending on drought conditions (Meléndez-Ackerman et al. 2018, entire). Partners continue analyzing the extent by which these changes may be related to changes in climatic variation in detail by analyzing data from meteorological stations in the region, and they recommend periodic monitoring of L. eltoroensis' s population status (Meléndez-Ackerman et al. 2018, p. 10). The Service will address this recommendation as part of the post-delisting monitoring plan (PDM) and will include criteria to determine whether population trends allow for completion of monitoring, or if additional monitoring or a status review is needed. Moreover, the University, in collaboration with the USFS and the Service, developed a habitat model showing that further suitable habitat extends outside traditionally surveyed areas, including areas of Pico El Yunque and Pico del Este (Sparklin 2020, unpublished data). This model is still pending validation in the field. Despite species experts recording direct impacts to L. eltoroensis due to Hurricane Maria and high mortality of seedlings following the disturbance, they also recorded at least 16 previously unknown host trees with live plants (new populations), showing the species may be more widespread within its habitat (Hernández-Muñiz et al., accepted for publication, entire).

This action has not been met but is no longer necessary. At the time of listing, only 140 plants were thought to exist; we now estimate a population size of 3,000 individuals (Tremblay 2008, p. 90). The 2015 5-year status review of Lepanthes eltoroensis states that the action to establish new populations is not necessary at this time for the recovery of the species because additional subpopulations and individuals have been found since the species was listed (Service 2015, p. 5). Additionally, relocation of plants from fallen trees onto standing trees following hurricane events was found to be an effective management strategy to improve and maximize survival and reproductive success (Benítez and Tremblay 2003, pp. 67-69). Recent work and habitat modeling also show that further suitable habitat extends outside traditionally surveyed areas, including areas of Pico El Yunque and Pico del Este.

This action has not been met but will no longer be necessary. The recovery plan states that as additional information on Lepanthes eltoroensis is gathered, it will be necessary to better define, and possibly modify, recovery criteria. Based on the information compiled in the SSA report (Service 2019, entire), this orchid is projected to remain viable over time such that it no longer meets the Act's definition of an endangered or threatened species (see Determination of Status of Lepanthes eltoroensis, below).

This criterion has been met. Existing populations and the species' habitat are protected by the USFS. This orchid species occurs within the El Toro Wilderness Area where habitat destruction or modification is no longer considered a threat to the species or its habitat. Thus, although there is not a specific agreement between the Service and the USFS concerning the protection of Lepanthes eltoroensis, the intent of this criterion—to provide long-term protection for the species—has been met. The implementation of management practices in the forest has improved, no selective cutting is conducted, and the USFS coordinates with the Service to avoid impacts to listed species as part of their management practices. Furthermore, Commonwealth laws and regulations protect the species' habitat, as well as protect the species from collection and removal. There is no evidence that L. eltoroensis or its habitat is being negatively impacted by forest management. Due to the high level of protection provided by the wilderness designation and other protections, we have determined that an agreement between the Service and the USFS is no longer necessary for protecting this species. Incidentally, because this species overlaps with other listed species, the USFS will continue to consult on projects that may affect this area.

As stated above under Recovery Action 4, we have found that the action to establish new populations is no longer necessary because additional subpopulations and individuals have been found since the species was listed (Service 2015, p. 5). Further, suitable habitat extends outside traditionally surveyed areas, including areas of Pico El Yunque and Pico del Este. Additionally, relocation of plants is an effective management strategy to improve and maximize survival and reproductive success, as has been demonstrated after hurricane events (Benítez and Tremblay 2003, pp. 67-69).

The recovery plan for Lepanthes eltoroensis provided direction for reversing the decline of this species, thereby informing when the species may be delisted. The recovery plan outlined two criteria for reclassifying the species from endangered to threatened: (1) Prepare and implement an agreement between the Service and the USFS concerning the protection of L. eltoroensis within EYNF, and (2) establish new populations capable of self-perpetuation within protected areas. These criteria have either been met or are no longer considered necessary. This species is protected by Commonwealth law and regulations and will continue to be should the species no longer require Federal protection, and the species occurs within a protected wilderness area that will remain protected and managed using techniques that are beneficial for this species and co-occurring federally listed species. There is no evidence that L. eltoroensis or its habitat is being negatively impacted by forest management activities or will be in the future. Additionally, the designation of wilderness where the species occurs has eliminated the need for an agreement between the Service and the USFS to protect this species. Since the species was listed under the Act and the recovery plan was written, additional plants have been found, additional plants likely exist in areas that are unsuitable for surveying, and the best available information indicates that additional habitat likely exists. Therefore, establishment of new populations is not necessary for recovery of L. eltoroensis at this time. Additionally, the five recovery actions intended to address threats to the species have all been either met or determined no longer to be necessary for recovery.

Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for determining whether a species is an “endangered species” or a “threatened species.” The Act defines an “endangered species” as a species that is in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act requires that we determine whether any species is an “endangered species” or a “threatened species” because of any of the following factors:

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

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

(C) Disease or predation;

(D) The inadequacy of existing regulatory mechanisms; or

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

These factors represent broad categories of natural or human-caused actions or conditions that could have an effect on a species' continued existence. In evaluating these actions and conditions, we look for those that may have a negative effect on individuals of the species, as well as other actions or conditions that may ameliorate any negative effects or may have positive effects. We consider these same five factors in reclassifying a species from endangered to threatened and in delisting a species (50 CFR 424.11(c)-(e)).

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

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

The Act does not define the term “foreseeable future,” which appears in the statutory definition of “threatened species.” Our implementing regulations at 50 CFR 424.11(d) set forth a framework for evaluating the foreseeable future on a case-by-case basis. The term foreseeable future extends only so far into the future as the Services can reasonably determine that both the future threats and the species' responses to those threats are likely. In other words, the foreseeable future is the period of time in which we can make reliable predictions. “Reliable” does not mean “certain”; it means sufficient to provide a reasonable degree of confidence in the prediction. Thus, a prediction is reliable if it is reasonable to depend on it when making decisions.

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

Given the average lifespan of the species (approximately 5 years), a period of 20 to 30 years allows for multiple generations and detection of any population changes. Additionally, the species has been listed for close to 30 years, so we have a baseline to understand how populations have performed in that period, which is a similar length of time as between now and mid-century. Therefore, the “foreseeable future” used in this determination is 20 to 30 years, which is the length of time into the future that the Service can reasonably determine that both the future threats and the species' responses to those threats are likely.

The SSA report documents the results of our comprehensive biological review of the best scientific and commercial data regarding the status of the species, including an assessment of the potential threats to the species. The SSA report does not represent our decision on whether the species should be reclassified as a threatened species or delisted under the Act. It does, however, provide the scientific basis that informs our regulatory decisions, which involve the further application of standards within the Act and its implementing regulations and policies. The following is a summary of the key results and conclusions from the SSA report; the full SSA report can be found at http://www.regulations.gov under Docket No. FWS-R4-ES-2019-0073.

To assess Lepanthes eltoroensis viability, we used the three conservation biology principles of resiliency, redundancy, and representation (Shaffer and Stein 2000, pp. 306-310). Briefly, resiliency supports the ability of the species to withstand environmental and demographic stochasticity (for example, wet or dry, warm or cold years); redundancy supports the ability of the species to withstand catastrophic events (for example, droughts, large pollution events), and representation supports the ability of the species to adapt over time to long-term changes in the environment (for example, climate changes). In general, the more resilient and redundant a species is and the more representation it has, the more likely it is to sustain populations over time, even under changing environmental conditions. Using these principles, we identified the species' ecological requirements for survival and reproduction at the individual, population, and species levels, and described the beneficial and risk factors influencing the species' viability.

The SSA process can be categorized into three sequential stages. During the first stage, we evaluated individual species' life-history needs. The next stage involved an assessment of the historical and current condition of the species' demographics and habitat characteristics, including an explanation of how the species arrived at its current condition. The final stage of the SSA involved making predictions about the species' responses to positive and negative environmental and anthropogenic influences. Throughout all of these stages, we used the best available information to characterize viability as the ability of a species to sustain populations in the wild over time. We use this information to inform our regulatory decision. Lepanthes eltoroensis was listed as an endangered species in 1991, due to its rarity (Factor E), its restricted distribution (Factor E), forest management practices (Factor A), impacts from hurricane damage (Factor E), and collection (Factor B) (56 FR 60933, November 29, 1991, p. 56 FR 60935). The most important factor affecting L. eltoroensis at that time was its limited distribution. Additionally, its rarity made the species vulnerable to impacts from hurricanes, such as unfavorable microclimatic conditions resulting from numerous canopy gaps. Because so few individuals were known to occur, the risk of extinction was considered to be extremely high (56 FR 60933, November 29, 1991, p. 56 FR 60935).

In this section, we review the biological condition of the species and its resources, and the threats that influence the species' current and future condition, in order to assess the species' overall viability and the risks to that viability.

At the time of listing (1991), management practices such as establishment and maintenance of plantations, selective cutting, trail maintenance, and shelter construction were considered threats to Lepanthes eltoroensis (56 FR 60933, November 29, 1991, p. 56 FR 60935). The recovery plan further indicated that destruction and modification of habitat might be the most significant factors affecting the number of individuals and distribution of the species (Service 1996, p. 5).

Since the species was listed, several laws have been enacted that provide protections to this species. In 1999, Commonwealth Law No. 241 (New Wildlife Law of Puerto Rico or Nueva Ley de Vida Silvestre de Puerto Rico ) was enacted to protect, conserve, and enhance native and migratory wildlife species (including plants). This law requires authorization from the PRDNER Secretary for any action that may affect the habitat of any species. Furthermore, part of EYNF (including the habitat where Lepanthes eltoroensis is currently known to occur) was congressionally designated as the El Toro Wilderness in 2005, to preserve its natural conditions, including species like L. eltoroensis, inhabiting the area (Caribbean National Forest Act of 2005 (Pub. L. 109-118); the Wilderness Act (16 U.S.C. 1131 et seq. ); U.S. Forest Service (USFS) 2016, p. 32). The El Toro Wilderness consists of undeveloped USFS lands and is managed to preserve its natural conditions without any permanent improvements or human habitation (USFS 2016, p. 32). All known populations of L. eltoroensis occur within this wilderness area.

Scientists who have conducted research on Lepanthes eltoroensis do not consider destruction, curtailment, or modification of this species' habitat to be a factor threatening this species (Ackerman 2007, pers. comm.). In 2019, the USFS finalized a revised land and resources management plan to guide the general direction of EYNF for the next 15 years. This plan specifically includes a set of standards and guidelines to protect the natural resources within the El Toro Wilderness, including listed species. Standards specific to the El Toro Wilderness include no salvaging of timber, no issuing permits for collection of plants or plant material unless for a scientific purpose, no new special-use permits for facilities or occupancy, managing recreation to minimize the number of people on the trails, and no construction of new trails (USFS 2019, pp. 1, 32-35). Standards and guidelines for at-risk (including listed) species detailed in the plan include not allowing collection of orchids unless approved for scientific purposes and making sure forest management activities are consistent with recovery plans (USFS 2019, p. 62). Implementation of management practices in EYNF has also improved; there is no selective cutting, and maintenance is minimal, as both El Toro and Trade Winds trails receive few visitors. Mostly researchers and forest personnel use El Toro and Trade Winds trails; therefore, few human encounters are expected (USFS 2016, p. 32). Additionally, the USFS coordinates with the Service to avoid or minimize impacts to a number of federally listed species ( e.g., the endangered plants Ilex sintenisii and palo colorado, and the threatened elfin-woods warbler) that co-occur with L. eltoroensis as part of their management practices in accordance with section 7 of the Act.

There is no evidence suggesting current forest management practices are negatively affecting the species or its specialized habitat (adequate temperature and moisture regimes, and presence of moss) (Service 2019, p. 24). Furthermore, based on existing laws, we expect EYNF will remain permanently protected as a nature reserve and be managed for conservation. Therefore, we no longer consider forest management practices or destruction and modification of habitat to be threats to the species.

The restricted distribution of Lepanthes eltoroensis makes it particularly vulnerable to large-scale disturbances, such as hurricanes and tropical storms, that frequently affect islands of the Caribbean (NOAA 2018, unpaginated). Hurricanes are more frequent in the northeastern quadrant of Puerto Rico, where EYNF is located (White et al. 2014, p. 30). Current global climate models are rather poor at simulating tropical cyclones; however, the Intergovernmental Panel on Climate Change's climate simulations project that the Caribbean will experience a decrease in tropical cyclone frequency, but the most intense events will become more frequent (PRCC 2013, p. 10; Service 2019, p. 56).

Cloud forests, where this species occurs, are much taller than other vegetation and are higher in elevation, making them more exposed and more easily affected by high winds, and they take more time to recover post-disturbance (Hu and Smith 2018, p. 827). Heavy rains and winds associated with tropical storms and hurricanes cause tree defoliation, habitat modification due to trees falling, and landslides (Lugo 2008, p. 368). Surveys in 2018 conducted along El Toro Trail following Hurricane Maria focused on assessing the impacts to the species and its host trees (subpopulations). Nineteen host trees were not found and assumed to be lost due to the hurricane. An additional nine host trees were found knocked down. In total, 641 plants, including seedlings, juveniles, and reproductive and non-reproductive adults, were found; 322 were found on previously marked host trees (including 191 individuals on those host trees that were knocked to the ground), and 319 were new individuals not previously surveyed (Melendez-Ackerman 2018, pers. comm.). Given that Lepanthes eltoroensis does not persist on felled or dead trees (Benítez and Tremblay 2003, pp. 67-69), we assume many of these 191 individuals (approximately 30 percent of individuals found) will not survive, resulting in the loss of those individuals from the metapopulation. However, individual plants moved to new host trees do quite well, highlighting the feasibility of relocation to increase the species' long-term viability in the context of severe hurricanes such as Hurricane Maria. University researchers translocated some of these 191 individuals, but because the translocations occurred months after the hurricane, we do not expect survival to be as high as if it had occurred immediately after the hurricane. Furthermore, this species has persisted from past hurricane events without active management of translocating species from felled host trees.

In addition, associated microclimate changes resulting from downed trees and landslides after severe storms ( e.g., increased light exposure, reduction in relative humidity) may negatively affect the growth rate of Lepanthes eltoroensis populations (Tremblay 2008, pp. 89-90). Following Hurricane Georges in 1998, non-transplanted populations of L. eltoroensis had negative growth rates, while groups of plants that were transplanted to better habitats within the forest had positive growth rates (Benitez-Joubert and Tremblay 2003, pp. 67-69). Furthermore, based on data on related species, L. eltoroensis growth rates may be negatively affected by excess light from gaps caused by felled trees during hurricanes (Fernandez et al. 2003, p. 76).

The inherently low redundancy (the ability of a species to withstand catastrophic events) of Lepanthes eltoroensis due to its limited range makes hurricanes and tropical storms a primary risk factor. However, given the observed stable trend from past surveys and recent partial surveys in 2018 (Service 2019, pp. 39, 45-48), it appears that the species has the ability to recover from disturbances like hurricanes Hugo, Georges, Hortense, Irma, and Maria (Service 2019, pp. 51-52). Additionally, relocation has proven to be a viable conservation strategy for this species (Benítez and Tremblay 2003, pp. 67-69). Relocating plants from fallen trees to standing trees following hurricane events results in higher survival of those transplanted individuals. This management strategy can improve and maximize species' survival and reproductive success after hurricane events (Benítez and Tremblay 2003, pp. 67-69; Tremblay 2008, pp. 83-90). Following this recommendation after Hurricane Maria, researchers from the University translocated some L. eltoroensis individuals along the El Toro Trail. These individuals are currently being monitored to assess survival. In addition, since L. eltoroensis is part of the USFS' “Plant Species of Conservation Interest of El Yunque” (USFS 2018, p. 37) and is included in the 2016 revised land and resource management plan that details a management concept focused on conservation, particularly to protect unique ecological resources (USFS 2016, p. 1), the USFS will continue to implement conservation actions, such as habitat protection, enhancement, and relocation of L. eltoroensis individuals following hurricanes, as deemed necessary.

Collection for commercial or recreational purposes eliminated one population of Lepanthes eltoroensis prior to listing under the Act (56 FR 60933; November 29, 1991). The rarity of the species made the loss of even a few individuals a critical loss to the species as a whole.

The USFS regulations in title 36 of the Code of Federal Regulations at part 261, section 261.9 (36 CFR 261.9) prohibit damaging or removing any plant that is classified as a threatened, endangered, sensitive, rare, or unique species in wilderness areas. Additionally, since the species was listed under the Act in 1991, other laws have been enacted that provide protections to the species from collection or removal. Commonwealth Law No. 241 (New Wildlife Law of Puerto Rico or Nueva Ley de Vida Silvestre de Puerto Rico ), enacted in 1999, protects, conserves, and enhances native and migratory wildlife species. Specifically, Article 5 of this law prohibits collection and hunting of wildlife species, including plants within the jurisdiction of Puerto Rico, without a permit from the PRDNER Secretary. In 2004, Lepanthes eltoroensis was included in the list of protected species of Regulation 6766 ( Reglamento 6766 para Regir el Manejo de las Especies Vulnerables y en Peligro de Extinción en el Estado Libre Asociado de Puerto Rico ), which governs the management of endangered and threatened species within the Commonwealth of Puerto Rico. Article 2.06 of this regulation prohibits collecting, cutting, and removing, among other activities, listed plant individuals within the jurisdiction of Puerto Rico.

Lepanthes eltoroensis will likely remain protected under Commonwealth laws and regulations after Federal delisting. Commonwealth Regulation 6766 provides protection to species that are not federally listed or that have been removed from the Federal Lists, and the species will remain protected under the wilderness provisions from the 2016 revised land and resource management plan for EYNF (USFS 2016, entire). According to this plan, any influences by humans on the natural process that take place in the wilderness area will be to protect endangered and threatened species in addition to human life (USFS 2016, p. 33). As such, the standards of the plan include conducting wildlife and plant habitat/population surveys and monitoring in a manner compatible with the goals and objectives of wilderness (USFS 2016, p. 34). Additional protection measures include not issuing forest product permits for collection of plants or plant material in wilderness areas (unless for scientific and educational purposes and approved by the forest biologist/ecologist), and management strategies to design, construct, and maintain trails to the appropriate trail standard in order to meet wilderness standards protections (USFS 2016, p. 34).

Despite the one documented instance of collection, the threat of collection is low, given that few people venture into the El Toro Wilderness (Tremblay 2007, pers. comm.) and that the small size (less than 2 in. (4 cm) tall) and inconspicuousness of this species makes it easy to overlook (Ackerman 2007, pers. comm.; Tremblay 2007, pers. comm.). Additionally, this species is not used for commercial or recreational purposes and is not considered to have ornamental value (Service 2015, p. 8). Despite photos of the species on the internet, there is no direct evidence that the species is in private collections or that it has been advertised for sale. In addition, since early 2017, researchers from the University monitored population trends on all known host trees on a monthly basis, and recorded no evidence of poaching ( e.g., unusual missing plants or scars on the trees). Thus, there is no evidence that collection is currently impacting Lepanthes eltoroensis (Service 2019, p. 24) or is likely to do so in the future.

The smaller the population, the greater the probability that fluctuations in population size from stochastic variation ( e.g., reproduction and mortality) will lead to extirpation. There are also genetic concerns with small populations, including reduced availability of compatible mates, genetic drift, and inbreeding depression. Small subpopulations of Lepanthes eltoroensis are particularly vulnerable to stochastic events, thus contributing to lower species viability (Service 2019, p. 24).

Lepanthes eltoroensis may experience declining growth related to the uneven distribution of individuals among host trees and demographic processes ( e.g., reproductive success, survival), which can be negatively influenced by environmental and catastrophic risks (Service 2019, p. 25). Fruit production is limited; therefore, opportunities for establishment are limited. Less than 20 percent of individuals reproduce, and most subpopulations (60 percent of host trees) have fewer than 15 individuals. In addition, the distribution of individuals (seedling, juvenile, and adults) varies enormously among trees and is skewed towards few individuals per tree (Tremblay and Velazquez-Castro 2009, p. 214). Despite small subpopulations of L. eltoroensis with limited distribution and naturally limited fruit production, this species has continued to recover even after regular exposure to disturbances. We now estimate the species population to be 3,000 individuals, which is a significant increase from the 140 individuals known at the time of listing (Tremblay 2008, p. 90). This is because surveys have located additional individuals and subpopulations (groups of L. eltoroensis on the same host tree), resulting in a much greater estimate of individuals than at the time of listing. Therefore, the species' vulnerability to extinction due to catastrophic events is reduced.

The main genetic risk factor for the species is low genetic variability. The effective population size (number of individuals in a population that contribute offspring to the next generation) ranges from 3 to 9 percent of the standing population (number of individuals in a population) (Tremblay and Ackerman 2001, entire). In other words, for every 100 adults, maybe 9 will transfer genes to the next generation. In addition, although Lepanthes eltoroensis can survive for up to 50 years, most seedlings and juveniles die (Tremblay 2000, p. 264). Therefore, very few individuals are responsible for the majority of seed production, decreasing the genetic diversity as a whole in subpopulations (Meléndez-Ackerman and Tremblay 2017, pp. 5-6). Low genetic diversity may be reflected in reduced genetic and environmental plasticity, and, thus, low ability to adapt to environmental changes. However, L. eltoroensis has demonstrated the ability to withstand environmental change; therefore, low genetic diversity does not appear to be affecting the species' viability.

There is evidence of low gene flow in the species. Estimated gene flow in Lepanthes eltoroensis is less than two effective migrants per generation (Tremblay and Ackerman 2001, p. 54). This result implies that most mating is among individuals within a host tree, potentially resulting in high inbreeding, low genetic variability, and inbreeding depression (Tremblay and Ackerman 2001, pp. 55-58). If there are high rates of inbreeding, this could lead to inbreeding depression, and could have profound long-term negative impacts to the viability of the species (Service 2019, pp. 28-29). However, the species is likely an obligate cross-pollinated species (Tremblay et al. 2006, p. 78), which is a mechanism to reduce inbreeding. Although the effects of potential inbreeding in the future is possible, the species has demonstrated the ability to adapt to changing environmental conditions ( i.e., natural disturbances) over time (Service 2019, p. 54). Thus, both low genetic diversity and low gene flow do not appear to be affecting species' viability currently, nor do we believe it will in the foreseeable future.

The average temperatures at EYNF have increased over the past 30 years (Jennings et al. 2014, p. 4; Khalyani et al. 2016, p. 277). Climate projections indicate a 4.6 to 9 degrees Celsius (°C) (8.2 to 16.2 degrees Fahrenheit (°F)) temperature increase for Puerto Rico from 1960-2099 (Khalyani et al. 2016, p. 275). Additionally, projections indicate a decrease in precipitation and acceleration of the hydrological cycles resulting in wet and dry extremes (Jennings et al. 2014, p. 4; Cashman et al. 2010, pp. 52-54). In one downscaled model, precipitation is projected to decrease faster in wetter regions like the Luquillo Mountains, where EYNF is located, and the central mountains of Puerto Rico (Khalyani et al. 2016, p. 274). In contrast, higher elevations may have a buffering effect on declining trends in precipitation (Bowden 2018, pers. comm.; Service 2019, pp. 65-66).

Downscaled modeling for Puerto Rico was based on three Intergovernmental Panel on Climate Change global emissions scenarios from phase 3 of the Coupled Model Intercomparison Project (the CMIP3 data set): Mid-high (A2), mid-low (A1B), and low (B1) as the CMIP5 data set was not available for Puerto Rico at that time (Khalyani et al. 2016, p. 267 and 279-280). These scenarios are generally comparable and span the more recent representative concentration pathways (RCP) scenarios from RCP4.5 (B1) to RCP8.5 (A2) (IPCC 2014, p. 57). Under all of these scenarios, emissions increase, precipitation declines, temperature and total dry days increase, and portions of subtropical rain and wet forests (that Lepanthes eltoroensis occupies) are lost, while all wet and moist forest types decrease in size in Puerto Rico; the differences in the scenarios depends on the extent of these changes and the timing of when they are predicted to occur (Service 2019, p. 67).

In general, projections show similar patterns of changes in precipitation and drought intensity and extremes, although total changes were greater for the A2 scenario (Khalyani et al. 2016, pp. 272-273, 274; Service 2019, pp. 59-60). Under scenarios A2, A1B, and B1, annual precipitation is projected to decrease. Current annual precipitation in Puerto Rico averages 745 to 4,346 mm (29 to 171 in.). However, differences in precipitation between the three scenarios were greater after mid-century, as was uncertainty of species' response to the various scenarios past mid-century (Khalyani et al. 2016, p. 274). Before then, decreases in rainfall are expected to be far less; rainfall decreases are expected to be 0.0012 to 0.0032 mm per day per year through 2050 (PRCC 2013, p. 7). Additionally, for all three climate scenarios, significant decreases in precipitation for the northern wet forests (like EYNF) are not predicted until after 2040 (Service 2019, p. 60). Furthermore, the U.S. Geological Survey projection for Puerto Rico predicts an overall drying of the island and a reduction in extreme rainfall occurrence; however, this model suggests higher elevations, like those supporting L. eltoroensis, may have a buffering effect on declining trends in precipitation (Bowden 2018, pers. comm.). Therefore, precipitation declines are not likely to occur in the area supporting L. eltoroensis during the foreseeable future. On the other hand, drought intensity increased steadily under all three scenarios (Khalyani et al. 2016, pp. 274-275). This increase is linear for all three scenarios. Given that the projections for precipitation and drought diverge significantly after midcentury, it is difficult to reasonably determine the species' response to the coming changes.

All three scenarios predict increases in temperature (Khalyani et al. 2016, p. 275). However, like with precipitation, projected increases in temperature are not substantial until after 2040. Projections show only a 0.8 °C (1.4 °F) increase by mid-century under all three scenarios. These scenarios differentiate the most from each other in later time intervals (after 2040) (Khalyani et al. 2016, pp. 275, 277). Also, we are not aware of any information that indicates these air temperature increases will influence formation of the cloud cover over EYNF in the foreseeable future, which could in turn impact interior temperatures and humidity of the forest where Lepanthes eltoroensis is found. The divergence of all scenarios after 2040 makes it difficult to predict the species' likely future condition; therefore, we are relying on species' response 20 to 30 years into the future.

Climatic changes are projected in the life zone distributions in Puerto Rico, although the changes vary by life zone and are predicted to be much more significant after mid-century. Because life zones are derived from climate variables ( e.g., precipitation and temperature), general changes in life zone distribution are similar to changes in climatic variables. For example, annual precipitation changes will result in shifts from wet and moist zones to drier zones (Khalyani et al. 2016, p. 275), and changes in temperature will result in changes from subtropical to tropical. Under all three scenarios, models show decreasing trends in size for areas currently classified as wet and moist zones, while increasing trends were observed in the size covered by dry zones (Khalyani et al. 2016, pp. 275, 279). Therefore, under all scenarios, reduction of the size of areas covered by subtropical rain and wet forests are anticipated. Nonetheless, the loss of wet and moist zones in the northeastern mountain area that supports Lepanthes eltoroensis is not predicted to be substantial, and the area is predicted to remain relatively stable until after 2040 (Service 2019 p. 69). This may be due to possible buffering effects of elevation across the island.

This projected shift of the life zones of Puerto Rico from humid to drier is the most important potential risk to Lepanthes eltoroensis. This includes changes in relative area and distribution pattern of the life zones, and the disappearance of humid life zones (Khalyani et al. 2016, p. 275). Decreased rainfall in northeastern Puerto Rico could cause migration, distribution changes, and potential extirpation of many species that depend on the unique environmental conditions of the rain forest (Weaver and Gould 2013, p. 62). These projections may have direct implications for L. eltoroensis because the acreage of the lower montane wet forest life zone it occupies could decrease, resulting in less habitat being available for the species. Epiphytes like L. eltoroensis could experience moisture stress due to higher temperatures and less cloud cover with a rising cloud base, affecting their growth and flowering (Nadkarni and Solano 2002, p. 584). Due to its specialized ecological requirements and restricted distributions within the dwarf forest, L. eltoroensis could be more adversely impacted by the effects of climate change than other species with wider distribution ( e.g., lower elevation species) and greater plasticity, thus reducing its viability. However, predictions of life zone changes are not expected to affect resiliency of L. eltoroensis within the foreseeable future (Service 2019, p. 69).

Overall, we anticipate the range of Lepanthes eltoroensis could contract due to changes in climatic variables leading to loss of wet and tropical montane habitats. Although changes to precipitation and drought, temperature, life zones, and hurricane severity are expected to occur on Puerto Rico, thereby affecting the species' habitat, they are not predicted to be substantial over the next 20 to 30 year foreseeable future. Modeling shows the divergence in these projections increases substantially after mid-century, making projections beyond 20 to 30 years more uncertain; as a result, the species' response to those changes beyond 30 years into the future is also uncertain (Khalyani et al. 2016, p. 275).

Climate change is a primary risk factor to the species; however, under all climate emission scenarios, Lepanthes eltoroensis is projected to remain moderately resilient within the foreseeable future. There is very little projected contraction of the wet and moist forests 30 years into the future. Although increasing catastrophic hurricanes are possible, relocation of plants and appropriate forest management can ameliorate some of these impacts. Overall, the viability of the species is predicted to remain stable despite climate change impacts.

We note that, by using the SSA framework to guide our analysis of the scientific information documented in the SSA report, we have not only analyzed individual effects on the species, but we have also analyzed their potential cumulative effects. We incorporate the cumulative effects into our SSA analysis when we characterize the current and future condition of the species. To assess the current and future condition of the species, we undertake an iterative analysis that encompasses and incorporates the threats individually and then accumulates and evaluates the effects of all the factors that may be influencing the species, including threats and conservation efforts. Because the SSA framework considers not just the presence of the factors, but to what degree they collectively influence risk to the entire species, our assessment integrates the cumulative effects of the factors and replaces a standalone cumulative effects analysis.

Viability is defined as the ability of the species to sustain populations in the wild over time. To assess the viability of Lepanthes eltoroensis, we used the three conservation biology principles of resiliency, representation, and redundancy (Shaffer and Stein 2000, pp. 306-310).

Factors that influence the resiliency of Lepanthes eltoroensis include abundance and growth trends within host trees; habitat factors such as elevation, slope, aspect, precipitation, temperature, and canopy cover; and presence of moss, mycorrhizal fungi, and pollinators. Influencing those factors are elements of L. eltoroensis' s ecology that determine whether populations can grow to maximize habitat occupancy, thereby increasing resiliency. Stochastic factors that have the potential to affect L. eltoroensis include impacts to its habitat from hurricanes and effects of climate change ( i.e., changes in temperature and precipitation regimes). Beneficial factors that influence resiliency include the protected status of the species' habitat, as the known range of the species is entirely within the El Toro Wilderness and, therefore, protected from human-caused habitat loss and collection.

The number of Lepanthes eltoroensis individuals is greater than at the time of listing (Tremblay 2008, p. 90), approximately 3,000 individual plants currently. The distribution of L. eltoroensis has not been investigated outside of traditional areas ( i.e., just off El Toro and Trade Wind trails); however, additional populations may occur within suitable habitat outside El Toro Trail. In fact, additional individuals have been found near, but outside of, El Toro Trail (Tremblay 2008, p. 90). Assuming a metapopulation size of 3,000 individuals and observed stable subpopulations from past surveys (including recent partial surveys in 2018), these numbers indicate that the species has the ability to recover from normal stochastic disturbances; thus, we consider the species to be moderately resilient.

We lack the genetic and ecological diversity data to characterize representation for Lepanthes eltoroensis. In the absence of species-specific genetic and ecological diversity information, we typically evaluate representation based on the extent and variability of habitat characteristics across the geographical range. Because the species does not appear to have much physiological flexibility given that it has a rather restricted distribution (cloud forests on ridges), representative units were not delineated for this species. Available data suggest that conditions are present for genetic drift and inbreeding depression (Tremblay 1997a, p. 92). However, the most updated L. eltoroensis information shows that the species survived the almost entire deforestation of the lowlands of EYNF (habitat surrounding the known localities of L. eltoroensis ) and the associated changes in microhabitat conditions, and thus the species has the ability to adapt to changing environmental conditions ( i.e., natural disturbances) over time and does not appear to be effected by genetic drift at present. Furthermore, some of the factors that we concluded would reduce representation at the time of listing, such as habitat destruction and collection, are no longer acting as stressors upon the species. Finally, because the population is significantly larger than was known at the time of listing, representation has improved. Redundancy for Lepanthes eltoroensis is the total number and resilience of subpopulations and their distribution across the species' range. This species is endemic to EYNF, and it has not been introduced elsewhere. Despite the presence of multiple subpopulations ( i.e., host trees), these subpopulations are located within a narrow/restricted range at El Toro Wilderness and are all exposed to similar specific habitat and environmental conditions. Although redundancy is naturally low due to the narrow range that the species inhabits, it has recovered from past natural disturbances ( i.e., hurricanes, tropical storms, etc.) and is considered more abundant within its habitat than previously documented, as noted above.

Lepanthes eltoroensis only occurs within the protected EYNF lands where stressors—including forest management practices, urban development surrounding EYNF, and overcollection—are not expected to be present or are expected to remain relatively stable. Because L. eltoroensis occurs on protected lands managed by the USFS, it will benefit from their ongoing conservation practices, which include the relocation of plants from fallen host trees after a hurricane, as deemed necessary, to alleviate the negative impacts of these storm events. The effect of genetic drift on the species into the future is unknown, but L. eltoroensis has thus far demonstrated the ability to adapt to changing environmental conditions ( i.e., natural disturbances) over time (Service 2019, pp. 51-52). The primary stressors affecting the future condition of L. eltoroensis are current and ongoing climate change (Meléndez-Ackerman and Tremblay 2017, p. 1) and the associated shifts in rainfall, temperature, and storm intensities. These stressors account for indirect and direct effects at some level to all life stages and across the species' range.

To examine the potential future condition of Lepanthes eltoroensis, we used three future scenarios based on climate change predictions for Puerto Rico (Khalyani et al. 2016, entire), which used global emission scenarios (mid-high (A2), mid-low (A1B), and low (B1) (Nakicenovic and Swart 2000, entire)) to capture a range of possible scenarios. Our assessment of future viability includes qualitative descriptions of the likely impacts of climate change under the above three scenarios from the literature and is intended to capture the uncertainty in the species' response to climate stressors as well as capture our lack of information on abundance and growth rates relative to each scenario.

Although modeling projects large changes in temperature and precipitation to Puerto Rico through 2100, the divergence in these projections increases substantially after mid-century, making projections beyond 20 to 30 years more uncertain (Khalyani et al. 2016, p. 275). By mid-21st century, Puerto Rico is predicted to be subject to a decrease in rainfall, along with increase drought intensity, particularly in wetter regions like EYNF (Khalyani et al. 2016, pp. 265, 274-275). Given the average lifespan of the species (approximately 5 years), a period of 20 to 30 years allows for multiple generations and detection of any population changes.

In summary, changes to precipitation and drought, temperature, and life zones are expected to occur on Puerto Rico, but are not predicted to be substantial within the foreseeable future. Although modeling shows changes to Puerto Rico through 2100, the divergence in these projections increases after mid-century, making projections beyond 20 to 30 years more uncertain; as a result, the species' response beyond 20 to 30 years is also uncertain.

These projected changes may have direct or at least indirect effects on Lepanthes eltoroensis; however, viability of the species under all scenarios is expected to remain stable within the foreseeable future (Service 2019, p. 71). Potential direct effects include a reduced number of seedlings as the number of dry days increase, a reduced number of fruits as minimum average temperature increases, and a reduced number of adults as maximum temperature increases (Olaya-Arenas et al. 2011, p. 2042). Indirect effects are related to potential changes in moss cover and composition due to temperature and precipitation changes. Data from related species showed that orchid density, growth, and establishment were positively associated with moss species richness (Crain 2012, pp. 15-16; Garcia-Cancel et al. 2013, p. 6). Therefore, a change in forest temperature and humidity could affect the establishment and distribution of moss and also L. eltoroensis (Service 2019, p. 11).

Persistence of the species through repeated past hurricanes and other storms indicates that the species has the ability to recover and adapt from disturbances. In fact, many researchers at EYNF have concluded that hurricanes are the main organizing force of the forests (Service 2019, p.71). The forests go through a cycle that averages 60 years, starting with great impact by winds and rain of a hurricane, and then 60 years of regrowth (Lugo 2008, p. 371). In those 60 years of regrowth, complete changes in the species that dominate the landscape can occur. Although the hurricane appears destructive, it can be constructive because it makes the area more productive—it rejuvenates the forest (Service 2019, p. 71). Currently, EYNF is at the initial phase of early succession following Hurricane Maria (2017), which produced severe tree mortality and defoliation, including Lepanthes eltoroensis host trees.

In general, we anticipate the range of the species may contract somewhat due to changes in climatic variables, although the loss of wet and moist zones in the northeastern mountain area that supports Lepanthes eltoroensis is not predicted to be substantial within the foreseeable future (Service 2019, p. 66). Any range contraction may be exacerbated by an increase in the frequency and severity of hurricanes. However, as the species occurs within EYNF, synergistic negative effects of development and deleterious forest management practices are unlikely threats to the species in the future. Lepanthes eltoroensis and its habitat at the EYNF are protected by congressional designation of El Toro Wilderness Area (Forest Plan 2016, p. 32), thus precluding human disturbance. Because the EYNF management plan includes a set of standards and guidelines to protect the natural resources within the El Toro Wilderness, including co-occurring federally listed species ( e.g., Ilex sintenisii and palo colorado) (Service 2019, pp. 1, 32-35), the Service anticipates continued implementation of conservation and management practices to improve the habitat of all species within the area, including actions to mitigate hurricane impacts.

To summarize the future viability of Lepanthes eltoroensis, resiliency is projected to remain moderate through at least the next 20 to 30 years under all future scenarios. As mentioned above, very little contraction of the wet and moist forests is predicted within this timeframe. Although increasing catastrophic hurricanes are possible, relocation of plants can ameliorate some of these impacts. Redundancy is expected to remain stable under all scenarios for the next 20 to 30 years. However, Lepanthes eltoroensis has persisted through catastrophic events in the past, and we expect it to remain viable within the foreseeable future. Because the species has a rather restricted distribution, representative units were not delineated for this species. The current condition of low genetic and environmental diversity, and little breadth to rely on if some plants are lost, is expected to continue under all scenarios, at least through the next 20 to 30 years. Available data suggest that conditions are present for genetic drift and inbreeding. However, Lepanthes eltoroensis has demonstrated the ability to adapt to changing environmental conditions ( i.e., natural disturbances) over time and does not appear to be affected by genetic drift.

In the proposed rule published on March 10, 2020 (85 FR 13844), we requested that all interested parties submit written comments on the proposed delisting of Lepanthes eltoroensis and the draft post-delisting monitoring (PDM) plan by May 11, 2020. We also contacted appropriate Federal and State agencies, scientific experts and organizations, and other interested parties and invited them to comment on the proposal and plan. 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 joint policy on peer review published in the Federal Register on July 1, 1994 (59 FR 34270), and the Service's August 22, 2016, Director's Memo on the Peer Review Process, we sought the expert opinions of five appropriate and independent specialists regarding the SSA report for Lepanthes eltoroensis. These peer reviewers have expertise in L. eltoroensis or similar epiphytic orchid species' biology or habitat, or climate change. We received comments from one of the five peer reviewers. The purpose of peer review is to ensure that our decisions are based on scientifically sound data, assumptions, and analyses.

We reviewed all comments received from the peer reviewer for substantive issues and new information contained in the Lepanthes eltoroensis SSA report. The peer reviewer generally concurred with our methods and conclusions, and provided additional information, clarifications, and suggestions to improve the final SSA report. We revised the final SSA, which supports this final rule, as appropriate, in response to the comments and suggestions we received from the peer reviewer.

We reviewed all public comments for substantive issues and new information regarding the species. Substantive comments we received during the comment period are addressed below and, where appropriate, are incorporated directly into this final rule.

(1) Comment: One commenter indicated that the species should not be delisted because the population growth rate is highly variable, and the population is generally decreasing; further, seedling individuals are slowly decreasing, and plant mortality is slowly increasing following Hurricane Maria in September 2017.

Our Response: The commenter did not provide substantial new information to support this comment. In addition, we do not have evidence indicating the species shows a long-term (over the past three decades) decreasing trend. In fact, the overall number of individuals detected has increased since the time of listing (1991) from 140 to approximately 3,000 individuals estimated along the Trade Winds Trail (Tremblay 2008, p. 90). Further populations (host trees) are expected to occur within suitable habitat just outside this trail in areas that have not yet been surveyed due to the inaccessibility and steepness of the terrain (Tremblay 2008, p. 90). Thus, the species' viability is supported by information showing an increased number of individuals over the past three decades.

The species' mean lifespan is approximately 5.2 years, with an average annual mortality rate of 10 percent; however, this mortality rate varies greatly among life stages, with increased survival of older stages (adults) (Tremblay 2000, p. 265; Rosa-Fuentes and Tremblay 2007, p. 207). This relatively short lifespan coupled with a relatively high mortality rate indicates that the species probably would have gone extinct were it not currently viable.

A seasonal decrease in number of seedlings may also be associated with transition to more mature stages (juveniles and non-reproductive adults). As expected, a higher mortality of seedlings (80.3 percent) was found 6 months after Hurricane Maria due to the changes in canopy structure and associated microhabitat conditions that promoted drought stress (Melendez-Ackerman et al. 2019, p. 4). However, an overall survival rate for monitored plants was found to be approximately 80 percent (Melendez-Ackerman et al. 2019, p. 5). In addition, in August 2018, at least 1,105 live individuals (768 in the El Toro trail and 337 in a portion of the Trade Winds trail) distributed across 61 phorophytes (host trees) were recorded after Hurricane Maria. While the surveyed number (1,105 individuals) is less than the estimated 3,000 population size, this is the result of monitoring of accessible habitat following the hurricane, and there is a consensus among experts that the species' distribution extends beyond the surveyed areas.

(2) Comment: Several commenters indicated that the species should not be delisted based on the impacts from hurricanes, including expected higher frequency and intensity of hurricanes associated with climate change. Commenters indicated that the species' habitat is still recovering from the impacts of Hurricane Maria in 2017, as shown by low percentage of forest cover (34 percent in June 2019), increase in higher monthly averages in minimum temperatures, and lower number of moss species. One commenter expressed that, in general, the occurrences of Lepanthes spp. are correlated with high levels of moss cover, moss cover seems to be important for orchid growth and survival, and moss cover was affected by the hurricane. The commenter also mentioned that the L. eltoroensis population is still at pre-hurricane levels, having only added 100 individuals during surveys conducted post-hurricane and comparing with the numbers obtained as part of the assessments commissioned by the Service prior to Hurricane Maria.

Our Response: As recognized in the proposed rule and the SSA report, we acknowledge the impacts from hurricanes and their expected higher frequency due to climate change. Lepanthes eltoroensis is endemic to El Toro and Trade Winds trails at El Yunque National Forest (EYNF), an area subject to recurrent hurricanes and storms. The continued presence and viability of the species through repeated past hurricanes ( e.g., Hugo, Hortense, Georges, Irma, and Maria) shows the species has the ability to overcome and adapt from such disturbances. In fact, the species survived the peak in deforestation in Puerto Rico, including deforestation of the lowlands of EYNF, and the impact of Hurricane San Felipe II in 1928, the only category 5 hurricane on record to directly impact Puerto Rico. Thus, the species has been exposed to extreme natural disturbance and landscape modification via forest cover loss and moss reduction at EYNF that likely resulted in changes in microhabitat conditions ( i.e., higher temperature and evapotranspiration) caused by these disturbances and stochastic events.

As addressed in the Lepanthes eltoroensis SSA report (Service 2019, p. 73), hurricanes are the main organizing force of the forests of EYNF, and the forests goes through a cycle that averages 60 years (Lugo 2008, p. 383). The cycle starts with great impact from winds and rain of a hurricane followed by 60 years of regrowth. Thus, L. eltoroensis is naturally adapted to hurricane disturbance, and we expected it to remain viable in habitats subject to such intermittent disturbances ( e.g., hurricanes) (Crain et al. 2019, p. 89).

Direct impacts to L. eltoroensis occurred from Hurricane Maria, and seedlings experienced high mortality following the disturbance (Melendez-Ackerman 2019, p. 4; Hernández-Muñiz et al., accepted for publication, entire). However, 16 previously unknown host trees (new populations) were recorded during post-hurricane surveys, indicating the species may be more widespread within its habitat (Melendez-Ackerman 2019, p. 2; Hernández-Muñiz et al., accepted for publication, entire).

Despite the species' apparent preference for caimitillo ( Micropholis garciniifolia ) (endemic to the higher elevations of EYNF) as a host tree, there are records of L. eltoroensis growing on palma de sierra ( Prestoea acuminata ) and helecho arboreo ( Cyathea arborea ), which are fast-growing species with widespread distributions within L. eltoroensis habitat whose abundance is favored by hurricanes. Therefore, the availability of potential host trees for L. eltoroensis should not be a limiting factor following hurricanes.

(3) Comment: One commenter indicated that the species should not be delisted because there is a need of crucial data on the species' reproductive biology ( e.g., breeding system and pollinators), the feasibility of propagation, habitat requirements, and the ecology of the species.

Our Response: We are required to make our determinations based on the best available scientific and commercial data at the time the determination is made. A need for further research on a species is not necessarily relevant to the question of whether the species meets the definition of an “endangered species” or a “threatened species.” Regardless of the mechanism for pollination of the species, reproduction and recruitment of Lepanthes eltoroensis is occurring, evidenced by the presence of different size classes. The reportedly low fruit set of the species is not atypical of orchids of this type; thus, we do not consider it a concern for the future viability of the species. Finally, delisting the species does not prevent continued research on the species.

(4) Comment: One commenter indicated that the species should not be delisted because its habitat has not been completely surveyed, and there is a need to gather information on the species' distribution and abundance.

Our Response: As stated above, we make our status determinations based on the best available scientific and commercial data at the time the determination is made. Our analysis of the best commercial and scientific information available indicates that Lepanthes eltoroensis does not meet the Act's definitions of an “endangered species” or a “threatened species.” Despite the limited range of this species, we determined that stressors either have not occurred, have been ameliorated, or are not expected to occur to the extent anticipated at the time of listing in 1991.

We acknowledge that the species has not been extensively surveyed outside the El Toro and Trade Winds trails due to the areas' remoteness and steep topography (Service 2019, p. 19). However, new occupied host trees were identified after Hurricane Maria, indicating the species extends beyond previously known areas. Additionally, species experts from University of Puerto Rico (University), in collaboration with the USFS and the Service, developed a habitat model using environmental variables such as elevation, aspect, and a topographic position index and heat load (Sparklin 2020, unpublished data). Although this model is pending field validation, the result from this analysis shows that further suitable habitat extends outside traditionally surveyed areas, including areas of Pico El Yunque and Pico del Este (Sparklin 2020, unpublished data).

For these reasons, current population numbers are likely underestimated as the species is expected to be more widespread particularly considering the pristine status of its habitat. Further, delisting the species does not prevent future study or habitat surveys.

(5) Comment: We received public comments indicating that the species should not be delisted because the Service has not completed the recovery actions stated in the species recovery plan. Two commenters indicated that the species should not be delisted because an agreement between the Service and the USFS concerning the protection of Lepanthes eltoroensis within the El Yunque National Forest property has not been prepared and implemented (Recovery Objective #1). In addition, two commenters indicated that the species should not be delisted because new populations (the number of which should be determined following the appropriate studies) capable of self-perpetuation have not been established within protected areas (Recovery Objective #2).

Our Response: Recovery plans provide roadmaps to species recovery, but are not required in order to achieve recovery of a species or to evaluate it for delisting. In addition, recovery plans are also nonbinding documents that rely on voluntary participation from landowners, land managers, and other recovery partners. A determination of whether a valid, extant species should be delisted is made solely on the question of whether it meets the Act's definitions of an “endangered species” or a “threatened species.” We have determined that Lepanthes eltoroensis does not.

As addressed under Recovery and Recovery Plan Implementation in the proposed rule (85 FR 13844, pp. 13852-13854), we consider the need for an agreement between the Service and USFS as obsolete. At the time the recovery plan was approved in 1996, this agreement was deemed as needed because the potential of habitat modification due to forest management practices ( e.g., establishment and maintenance of plantations, selective cutting, trail maintenance, and shelter construction). However, the habitat where L. eltoroensis is found was congressionally designated as El Toro Wilderness Area in 2005. This designation provides stronger protection for L. eltoroensis than a conservation agreement would. The designated wilderness area is managed to retain primitive character without any permanent improvements or human habitation, and to preserve its natural conditions (USFS 2016, pp. 32-35). Currently, trails across L. eltoroensis habitat are used mostly by researchers and forest personnel; few human encounters are expected on these trails (USFS 2016, pp. 32-35), and no evidence indicates that forest management practices are negatively impacting the species.

Also addressed under Recovery and Recovery Plan Implementation in the proposed rule (85 FR 13844, pp. 13852-13854), the second recovery criterion regarding establishment of new populations capable of self-perpetuation within protected areas is no longer necessary because additional populations (host trees) and individuals have been found since the species was listed. In addition, new host trees have been found as part of increased survey efforts. Moreover, recent habitat modeling indicates suitable habitat extends beyond traditional surveyed areas; thus, population numbers are expected to be higher.

(6) Comment: Several commenters indicated that the species should not be delisted because it is still threatened by potential overutilization for commercial, recreational, scientific, or educational purposes (Factor B); disease or predation (Factor C); the inadequacy of existing regulatory mechanisms (Factor D); and other natural or manmade factors (Factor E). Particularly, one commenter highlighted the potential impacts due to overutilization for commercial and recreational purposes and that the species may be in private collections. One commenter indicated that several Lepanthes species may exist ex-situ in private collections in the Netherlands, provided a photo, and suggested further investigation to potential poaching is needed.

Our Response: The commenters did not provide substantial new information indicating that Factors B, C, D, and E are threats to Lepanthes eltoroensis. We are proactively collaborating with the species' experts, and no specific information on these issues have been brought to our attention or highlighted as a threat. As for the potential poaching of the species, the known populations and prime habitat occur on Federal lands congressionally designated as the El Toro Wilderness to preserve its natural conditions, including L. eltoroensis. Standards specific to the El Toro Wilderness include no salvaging of timber, no issuing permits for collection of plants or plant material unless for a scientific purpose, no new special-use permits for facilities or occupancy, managing recreation to minimize the number of people on the trails, and no construction of new trails. In addition, the known populations of L. eltoroensis occur on remote areas with little human traffic, and are subject to surveillance by USFS law enforcement officers. The Netherlands record is from a photo, and it is not clear that it is actually from a private collection. There is no evidence indicating that Lepanthes eltoroensis has been advertised for sale or that it is in private collections. In addition, there is no historical or current evidence of poaching of the species.

Section 4 of the Act (16 U.S.C. 1533), and its implementing regulations (50 CFR part 424), set forth the procedures for determining whether a species meets the definition of “endangered species” or “threatened species.” The Act defines an “endangered species” as a species that is in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. For a more detailed discussion on the factors considered when determining whether a species meets the definition of an endangered species or a threatened species and our analysis on how we determine the foreseeable future in making these decisions, please see Regulatory and Analytical Framework.

After evaluating threats to the species and assessing the cumulative effect of the threats under the section 4(a)(1) factors, we note that more individuals are known to occur than at the time of listing. Additionally, the best metapopulation estimate of 3,000 individuals is likely an underestimate, as not all potential habitat has been surveyed. Despite the effects of a small population size, continued limited distribution, and conditions rife for low gene flow (Factor E), the species has adapted to changing environmental conditions. Threats from incompatible forest management practices (Factor A) and collection (Factor B) have been addressed by regulatory changes, and are not anticipated to negatively affect Lepanthes eltoroensis in the future. Although hurricanes (Factor E) have the potential to negatively impact growth rates and survival of L. eltoroensis, stable subpopulations, even after recent severe hurricanes, indicate this species recovers from these natural disturbances. The greatest threat to the future of L. eltoroensis comes from the effects of climate change (Factor E); however, while changes to precipitation and drought, temperature, and life zones are expected to occur on Puerto Rico, they are not predicted to be substantial within the foreseeable future, and the viability of the species is expected to remain stable. We anticipate small population dynamics (small population size and restricted gene flow) (Factor E) will continue to be a concern, as conditions for genetic drift are present, nonetheless L. eltoroensis has demonstrated the ability to adapt to changing environmental conditions over time at population levels lower than they are currently or projected to be in the future.

The species was originally listed as an endangered species due to its rarity, restricted distribution, specialized habitat, and vulnerability to habitat destruction or modification, as well as because of collection for commercial/recreational uses. We find that these threats are no longer affecting the status of the species, as they have been minimized or eliminated. Surveys over the past 18 years, including following two strong hurricanes in 2018, documented more individuals than known at the time of listing, and the population appears to be relatively stable. The habitat at EYNF, where the species occurs, is a designated wilderness area and managed for its natural conditions; we conclude that this legal protection has addressed the threat of habitat modification or destruction to the degree that it is no longer a threat to the species continued existence. In addition, collection is prohibited under Puerto Rican law and USFS regulations, and there is no indication this is a current threat to the species. Stability of the species through repeated past strong hurricanes indicates the species has the ability to coexist with disturbances. While a narrow endemic, the species has continued to be viable across its historical range with all life stages represented and in good health. While projections show increasing temperatures and decreasing precipitation over time into the future, projected impacts to the species' habitat ( e.g., life zone changes) are not expected to be significant within the foreseeable future (Service 2019, p. 69). Recent, yet unpublished, downscaled climate modeling (Bowden 2018, pers. comm.) indicates that higher elevation areas, like those supporting L. eltoroensis, may be buffered from the more generally predicted level of precipitation changes. This species has also demonstrated the ability to adapt to changes in its environment. Since the species was listed, warming temperatures have been documented and precipitation levels have decreased, yet the species has demonstrated resiliency. Additionally, following strong hurricanes that affected the species' habitat, abundance has remained stable, with all age classes represented and in good health. While suitable habitat conditions for the species may contract some over the foreseeable future, the species is likely to continue to maintain close to current levels of resiliency, redundancy, and representation. We conclude that there are no existing or potential threats that, either alone or in combination with others ( i.e., forest management practices, climate change, and hurricane damage), are likely to cause the species' viability to decline. Thus, after assessing the best available information, we determine that L. eltoroensis is not in danger of extinction now nor likely to become so within the foreseeable future throughout all of its range.

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

In undertaking this analysis for Lepanthes eltoroensis, we choose to address the status question first—we consider information pertaining to the geographic distribution of both the species and the threats that the species faces to identify any portions of the range where the species is endangered or threatened. Lepanthes eltoroensis is a narrow endemic that functions as a single, contiguous population (with a metapopulation structure) and occurs within a very small area (EYNF, Puerto Rico). Thus, there is no biologically meaningful way to break this limited range into portions, and the threats that the species faces affect the species throughout its entire range. This means that no portions of the species' range have a different status from its rangewide status. Therefore, no portion of the species' range can provide a basis for determining that the species is in danger of extinction now or likely to become so in the foreseeable future in a significant portion of its range, and we find the species is not in danger of extinction now or likely to become so in the foreseeable future in any significant portion of its range. This is consistent with the courts' holdings in Desert Survivors v. Department of the Interior, No. 16-cv-01165-JCS, 2018 WL 4053447 (N.D. Cal. Aug. 24, 2018), and Center for Biological Diversity v. Jewell, 248 F. Supp. 3d, 946, 959 (D. Ariz. 2017).

Our review of the best available scientific and commercial data indicates that Lepanthes eltoroensis does not meet the definition of an endangered species or a threatened species in accordance with sections 3(6) and 3(20) of the Act. Therefore, we are removing Lepanthes eltoroensis from the Federal List of Endangered and Threatened Plants.

This final rule revises 50 CFR 17.12(h) to remove Lepanthes eltoroensis from the Federal List of Endangered and Threatened Plants. Therefore, revision of the species' recovery plan is not necessary. On the effective date of this rule (see DATES , above), the prohibitions and conservation measures provided by the Act, particularly through sections 7 and 9, no longer apply to this species. Federal agencies will no longer be required to consult with the Service under section 7 of the Act in the event that activities they authorize, fund, or carry out may affect L. eltoroensis. There is no critical habitat designated for this species.

Section 4(g)(1) of the Act requires us to monitor 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 monitor the species to ensure that its status does not deteriorate, and if a decline is detected, to take measures to halt the decline so that proposing it as an endangered or threatened species is not again needed. If at any time during the monitoring period data indicate that protective status under the Act should be reinstated, we can initiate listing procedures, including, if appropriate, emergency listing. At the conclusion of the monitoring period, we will review all available information to determine if relisting, the continuation of monitoring, or the termination of monitoring is appropriate.

Section 4(g) of the Act explicitly requires that we cooperate with the States in development and implementation of PDM programs. However, we remain ultimately 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. The Service has coordinated with PRDNER and USFS on the PDM.

We prepared a PDM plan for Lepanthes eltoroensis (Service 2019, entire). We published a notice of availability of a draft PDM plan with the proposed delisting rule (85 FR 13844; March 10, 2020), and we did not receive any comments on the plan. Therefore, we consider the plan final. The plan is designed to detect substantial declines in the species, with reasonable certainty and precision, or an increase in threats. The plan:

(1) Summarizes the species' status at the time of proposed 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) Provides a PDM implementation schedule, funding, and responsible parties.

The final PDM plan is available at https://ecos.fws.gov and at http://www.regulations.gov in Docket No. FWS-R4-ES-2019-0073. It is our intent to work with our partners towards maintaining the recovered status of Lepanthes eltoroensis.

We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act (NEPA; 42 U.S.C. 4321 et seq. ), need not be prepared in connection with determining a species' listing status under the Endangered Species Act. In an October 25, 1983, notice in the Federal Register (48 FR 49244), we outlined our reasons for this determination, which included a compelling recommendation from the Council on Environmental Quality that we cease preparing environmental assessments or environmental impact statements for listing decisions.

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 (Consultation and Coordination With Indian Tribal Governments), 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 there are no Tribal interests affected by this rule.

A complete list of references cited in this rulemaking is available on the internet at http://www.regulations.gov under Docket No. FWS-R4-ES-2019-0073 and upon request from the Caribbean Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT ).

The primary authors of this rule are the staff members of the Service's Species Assessment Team and 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: