Federal Register Vol. 81, No.193,

Background

A federally inspected meat or poultry establishment is required to use labels that are in compliance with the Federal Meat Inspection Act (FMIA; 21 U.S.C. 601 et seq., 607), the Poultry Products Inspection Act (PPIA; 21 U.S.C. 451 et seq., 457), and the implementing regulations. Requirements include all mandatory labeling requirements as prescribed in Title 9 of the Code of Federal Regulations section 317.2 and 381 Subpart N.

All labels with special claims, including animal-raising claims, need to be submitted to FSIS prior to being used on the product under 9 CFR 412.1(c)(3). As with all labels with special claims, labels with animal-raising claims must be submitted to the Labeling and Program Delivery Staff, Office of Policy and Program Development in FSIS with specific documentation to support all such claims that appear on that label. Examples of animal-raising claims include, but are not limited to: “Raised Without Antibiotics,” “Organic,” “Grass-Fed,” “Free-Range,” and “Raised without the use of hormones.” For most animal-raising claims, the documentation typically needed to support these claims includes:

1. A detailed written description explaining the controls used for ensuring that the raising claim is valid from birth to harvest or the period of raising being referenced by the claim;

2. A signed and dated document describing how the animals are raised (e.g., vegetarian-fed, raised without antibiotics, grass-fed), to support that the specific claim made is truthful and not misleading;

3. A written description of the product-tracing and segregation mechanism from time of slaughter or further processing through packaging and wholesale or retail distribution;

4. A written description for the identification, control, and segregation of non-conforming animals or products; and

5. If a third party certifies a claim, a current copy of the certificate.

FSIS previously issued a compliance guideline on animal-raising claims in 2002. The changes included in this version of the guideline include definitions for frequently used animal-raising claims, the detailed supporting documentation required for each specific claim that appears on the label, additional information regarding the claim grass fed, information required for duplicating raising claims from purchased product, and examples of labels bearing claims.

This guideline represents FSIS's current position and procedures for approving animal-raising claims, and although FSIS is requesting comments on this guideline and may update it in response to comments, FSIS encourages establishments that wish to submit request for approvals of animal raising claims on product labels to begin using this guideline.

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

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

No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination, any person in the United States under any program or activity conducted by the USDA.

To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at: http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your authorized representative.

Send your completed complaint form or letter to USDA by mail, fax, or email:

Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410.

Fax: (202) 690-7442.

Email: [email protected].

Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.) should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).

The final regulations (TD 9784) that are the subject of this correction are under section 856 of the Internal Revenue Code.

As published, the final regulations (TD 9784) contain errors that may prove to be misleading and are in need of clarification.

Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments:

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency, for good cause, finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. While the Arkansas Boathouse Club notified the Coast Guard that it will be conducting a rowing regatta, the “Six Bridges Regatta”, from 7 a.m. until 7 p.m. on October 14 and 15, 2016, the final details of this event were not made known to the Coast Guard until early September, leaving an insufficient amount of time remaining to publish an NPRM. It is impracticable to publish an NPRM because we must establish this safety zone by October 14, 2016.

We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this temporary rule effective less than 30 days after publication in the Federal Register. For the same reasons discussed in the preceding paragraph, waiting for a 30 day notice period to run would be impracticable.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. The COTP has determined that potential hazards posed to participants of a rowing regatta in this section of river would be a safety concern for anyone transiting the river from mile marker 117.4 to 118.6. The purpose of this rulemaking is to ensure the safety of event participants and other waterway users in U.S. navigable waters from mile marker 117.4 to 118.6 before, during, and after the scheduled event.

This rule establishes a special local regulation, enforced from 7 a.m. until 7 p.m. each day on October 14 and 15, 2016. In light of the aforementioned hazards, the COTP has determined that a special local regulation is necessary to protect spectators, vessels, and participants. The special local regulation will encompass the following waterway: All waters of the Arkansas River between mile markers 117.4 and 118.6 in the vicinity of Little Rock, AR.

This regulation prohibits entry by all vessels, mariners, and persons into the event area, a 1.2 mile stretch of the Arkansas River extending 25-yards from the left descending bank. All vessels transiting the regulated area outside of the 25-yard zone will be limited to slowest speed for safe navigation to minimize wake unless specifically authorized by the Captain of the Port Memphis.

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 (E.O.) 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. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

The Coast Guard's use of this special local regulation will be only 12 hours in duration each day on a Friday and a Saturday, and it is designed to minimize the impact on navigation. Moreover, vessels will be allowed to transit the marked navigation channel outside the 25 yards from left descending bank from mile marker 117.4 to mile marker 118.6 at the slowest speed for safe navigation to minimize wake unless specifically authorized by the Captain of the Port Memphis. Overall, the Coast Guard expects minimal impact to vessel movement from the enforcement of this special local regulation.

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

This rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in this portion of the Arkansas River in the vicinity of Little Rock, AR between 7 a.m. on October 14, 2016 and 7 p.m. on October 15, 2016.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. 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 E.O. 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 E.O. 13132.

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination 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 the establishment of a special local regulation lasting 12 hours each day over the course of a Friday and Saturday. Normally such actions are categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist and Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

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

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

Tropospheric ozone, commonly known as smog, occurs when VOC and nitrogen oxides (NOX) react in the atmosphere in the presence of sunlight. Because of the harmful health effects of ozone, EPA and state governments limit the amount of VOC and NOX that can be released into the atmosphere. VOC are those compounds of carbon (excluding carbon monoxide, carbon dioxide, carbonic acid, metallic carbides or carbonates, and ammonium carbonate) that form ozone through atmospheric photochemical reactions. Compounds of carbon (or organic compounds) have different levels of reactivity; they do not react at the same speed or do not form ozone to the same extent.

Section 302(s) of the CAA specifies that EPA has the authority to define the meaning of “VOC,” and hence what compounds shall be treated as VOC for regulatory purposes. It has been EPA's policy that compounds of carbon with negligible reactivity need not be regulated to reduce ozone and should be excluded from the regulatory definition of VOC. See 42 FR 35314 (July 8, 1977), 70 FR 54046 (September 13, 2005). EPA determines whether a given carbon compound has “negligible” reactivity by comparing the compound's reactivity to the reactivity of ethane. EPA lists these compounds in its regulations at 40 CFR 51.100(s) and excludes them from the definition of VOC. The chemicals on this list are often called “negligibly reactive.” EPA may periodically revise the list of negligibly reactive compounds to add or delete compounds.

EPA issued final rules approving the addition of trans-1,3,3,3-tetrafluropropene (also known as HFO-1234ze) and 2-amino-2-methyl-1-propanol (AMP) to the list of those compounds excluded from the regulatory definition of VOC. See 77 FR 37610 (June 22, 2012) and 79 FR 17037 (March 27, 2014). Georgia is updating its SIP to be consistent with those changes to federal regulations.

On July 25, 2014, and November 1, 2015, Georgia submitted SIP revisions 1 to EPA for review and approval. The revisions modify the definition of VOC found at Georgia's Rule 391-3-1-.01(llll), “Volatile Organic Compounds.” Specifically, the revisions add trans-1,3,3,3-tetrafluropropene (also known as HFO-1234ze) and 2-amino-2-methyl-1-propanol (AMP) to the list of compounds excluded from the VOC definition on the basis that each of these compounds makes a negligible contribution to tropospheric ozone formation.

These changes are consistent with section 110 of the CAA and meet the regulatory requirements pertaining to SIPs. Pursuant to CAA section 110(l), the Administrator shall not approve a revision of a plan if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress (as defined in CAA section 171), or any other applicable requirement of the Act. The revisions to Rule 391-3-1-.01(llll), “Volatile Organic Compounds,” are approvable under section 110(l) because they reflect changes to federal regulations based on findings that the aforementioned compounds are negligibly reactive.

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 Rule 391-3-1-.01 “Definitions” effective August 3, 2015, which revised the definition of VOC.2 Therefore, this material has been approved by EPA for inclusion in the SIP, has been incorporated by reference by EPA into that plan, is 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 by the Director of the Federal Register in the next update to the SIP compilation.3 EPA has made, and will continue to make, these materials generally available through www.regulations.gov and/or at the EPA Region 4 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

Pursuant to section 110 of the CAA, EPA is approving the aforementioned changes to Georgia's SIP for Rule 391-3-1-.01(llll). EPA has evaluated the relevant portions of Georgia's July 25, 2014, and November 1, 2015, SIP revisions and has determined that they meet the applicable requirements of the CAA and EPA regulations and are consistent with EPA policy.

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should adverse comments be filed. This rule will be effective December 5, 2016 without further notice unless the Agency receives adverse comments by November 4, 2016.

If EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on December 5, 2016 and no further action will be taken on the proposed rule.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. See 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 (Public Law 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).

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 as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

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 December 5, 2016. 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. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR part 52 is amended as follows:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 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-2016-0193 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 5, 2016. 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-2016-0193, 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.

EPA, on its own initiative, in accordance with FFDCA sections 408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing time-limited tolerances for residues of tolfenpyrad, 4-chloro-3-ethyl-1-methyl-N-[4-(p-tolyloxy)benzyl]pyrazole-5-carboxamide, in or on agricultural commodities in the group “vegetable, fruiting, group 8-10” at 0.70 parts per million (ppm). These time-limited tolerances expire on December 31, 2019.

Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of FFDCA section 408 and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

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

Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

The Florida Department of Agriculture and Consumer Services (FDACS) requested an emergency exemption for the use of tolfenpyrad on fruiting vegetables to reduce damage incurred by thrips. Thrips have become a severe problem in Florida on account of their developing resistance to the insecticides currently registered for use on fruiting vegetable crops, combined with the appearance of Tomato Chlorotic Spot Virus, a newly established invasive virus disease vectored by thrips attacking fruiting vegetables. According to FDACS, substantial economic damage is occurring and 30% to 90% yield loss has been documented due to the insufficient efficacy of registered alternatives.

After having reviewed the submission, EPA determined that an emergency condition exists for this State, and that the criteria for approval of an emergency exemption are met. EPA has authorized a specific exemption under FIFRA section 18 for the use of tolfenpyrad on vegetable, fruiting, group 8-10 for control of thrips in Florida.

As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of tolfenpyrad in or on vegetable, fruiting, group 8-10. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerances under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent, non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in FFDCA section 408(l)(6). Although these time-limited tolerances expire on December 31, 2019, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on vegetable, fruiting, group 8-10 after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether tolfenpyrad meets FIFRA's registration requirements for use on vegetable, fruiting, group 8-10 or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of tolfenpyrad by a State for special local needs under FIFRA section 24(c), nor does this tolerance by itself serve as the authority for persons in any State other than Florida to use this pesticide on the applicable crops under FIFRA section 18, absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for tolfenpyrad, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.

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

Consistent with the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of, and to make a determination on, aggregate exposure expected as a result of this emergency exemption request and the time-limited tolerances for residues of tolfenpyrad on vegetable, fruiting, group 8-10 at 0.70 ppm. EPA's assessment of exposures and risks associated with establishing time-limited tolerances follows.

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

A summary of the toxicological profile and endpoints for tolfenpyrad used for human health risk assessment is discussed in Table 1 of the final rule published in the Federal Register of January 9, 2014, (79 FR 1599) (FRL-9904-70).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to tolfenpyrad, EPA considered exposure under the time-limited tolerances established by this action 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 assessment 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 (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). For purposes of this acute exposure assessment, EPA assumed 100 percent crop treated (PCT) and tolerance-level residues.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption information from the USDA 2003-2008 NHANES/WWEIA. For purposes of this chronic exposure assessment, EPA relied upon average residue levels from crop field trials. EPA also used PCT estimates (discussed further in Unit IV.B.1.iv., below) for certain commodities that were shown to have a high contribution to the overall dietary exposure, while assuming 100 PCT for the rest of the commodities.

iii. Cancer. Based on the data summarized in Unit IV.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, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

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, 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.

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT for chronic 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 one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.

In this case, EPA used data from the USDA NASS Agricultural Chemical Usage—Fruit Summary (2003, 2005, 2007, 2009), Vegetable Summary (2004, 2006, 2010), along with proprietary data to estimate PCT for four commodities (all others being assumed to be 100 PCT). Based on that data, EPA estimated average PCTs of 40% for oranges, 60% for apples, 65% for table grapes, and 50% for spinach.

The Agency believes that the three conditions discussed in Unit IV.B1.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. 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://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of tolfenpyrad for acute exposures are estimated to be 26.9 parts per billion (ppb) for surface water and 11 ppb for ground water. For chronic exposures for non-cancer assessments, the EDWCs are estimated to be 12.2 ppb for surface water and 11 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.

For acute dietary risk assessment, the water concentration value of 26.9 ppb was used to assess the contribution to drinking water.

For chronic dietary risk assessment, the water concentration value of 12.2 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). 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://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

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

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

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

2. Prenatal and postnatal sensitivity. No evidence of increased quantitative or qualitative susceptibility was observed in developmental toxicity studies in rats or rabbits or a reproduction toxicity study in rats. However, the developmental immunotoxicity study (DIT) in rats suggests increased qualitative susceptibility in the young, since toxicity observed in offspring animals was more pronounced than toxicity seen in maternal animals at the same dose. No evidence of quantitative susceptibility was seen in the study. There is low concern and there are no residual uncertainties regarding the increased qualitative prenatal and/or postnatal susceptibility observed for tolfenpyrad. When the DIT and the reproduction study are considered together, the offspring toxicity in the DIT is comparable in severity to maternal toxicity observed at the same dose in the reproduction study. Since the adverse effects in young occurred at exposure levels that have shown comparable effects in adults, EPA does not consider the DIT persuasive evidence of an increased susceptibility of infants or children to tolfenpyrad. Additionally, the effects observed in the DIT study are well-characterized, a clear NOAEL was identified, and the endpoints chosen for risk assessment are protective of potential offspring effects, since a dermal hazard was not identified for tolfenpyrad, inhalation risk assessments are based on a route specific inhalation study, and the POD used for chronic dietary risk assessment is lower than where offspring effects were seen in the DIT study.

3. Conclusion. EPA has determined that reliable data show that 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.

ii. There is no indication that tolfenpyrad is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. Although there is possibly increased qualitative susceptibility in the young in the DIT study in rats, there are no residual uncertainties regarding increased susceptibility for tolfenpyrad since, (1) comparable maternal toxicity was observed at the same dose in the reproduction study, (2) the offspring effects observed in the DIT study are well characterized and there is a clear NOAEL for the effects seen, (3) no evidence of quantitative susceptibility was seen in the DIT study and susceptibility was not observed (quantitative or qualitative) in rat or rabbit developmental toxicity or reproduction studies tested at similar doses, (4) the endpoints and PODs selected for risk assessment are protective, and (5) direct non-dietary exposure to children is not anticipated since there are no residential uses for tolfenpyrad. Thus, a 10X FQPA safety factor is not necessary to protect infants and children.

iv. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to tolfenpyrad in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by 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. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water and relevant residential exposure scenarios. Since acute residential exposure is not anticipated, acute aggregate risk from exposure to tolfenpyrad results from exposure to residues in food and drinking water alone. Therefore, acute aggregate risk estimates are equivalent to the acute dietary risk estimates. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to tolfenpyrad will occupy 56% of the aPAD for the U.S. general population. Children 3-5 years old are the highest-exposed population subgroup with an estimated exposure of 81% of the aPAD. Typically, EPA has concerns when estimated exposures exceed 100% of the acute or chronic population-adjusted dose (aPAD or cPAD). Acute dietary risk estimates are below EPA's level of concern for all populations.

2. Chronic risk. A chronic aggregate risk assessment takes into account chronic exposure estimates from dietary consumption of food and drinking water and relevant residential exposure scenarios. Since chronic residential exposure is not anticipated for tolfenpyrad, chronic aggregate risk from exposure to tolfenpyrad results from exposure to residues in food and drinking water alone. Therefore, chronic aggregate risk estimates are equivalent to the chronic dietary risk estimates. 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 69% of the cPAD for (children 1-2 years old) the population group receiving the greatest exposure. There are no residential uses for tolfenpyrad.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background (average) exposure level). A short-term adverse effect was identified; however, tolfenpyrad is not registered for any use patterns that would result in short-term residential exposure. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for tolfenpyrad.

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

An intermediate-term adverse effect was identified; however, tolfenpyrad is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for tolfenpyrad.

5. 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.

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

An adequate enforcement methodology (liquid chromatography/tandem mass spectrometry (LC/MS/MS)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

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

The Codex has not established a MRL for tolfenpyrad residues in/on fruiting vegetables.

Therefore, a time-limited tolerance is established for residues of tolfenpyrad, (4-chloro-3-ethyl-1-methyl-N-[4-(p-tolyloxy)benzyl]pyrazole-5-carboxamide, in or on the agricultural commodity “vegetable, fruiting, group 8-10” at 0.70 ppm. This tolerance expires on December 31, 2019.

This action establishes a tolerance under FFDCA sections 408(e) and 408(l)(6). 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 in accordance with FFDCA sections 408(e) and 408(l)(6), 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, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing 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-2016-0330 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 5, 2016. 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-2016-0330, 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 July 20, 2016 (81 FR 47150) (FRL-9948-45), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-10925) filed by Momentive Performance Materials, 260 Hudson River Rd., Waterford, NY 12188. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of acrylic acid-butyl acrylate-styrene copolymer; CAS Reg. No. 25586-20-3. That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. The Agency did not receive any comments.

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

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

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). Acrylic acid-butyl acrylate-styrene copolymer conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.

1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.

3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).

4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.

5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.

7. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as listed in 40 CFR 723.250(d)(6).

Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e).

8. The polymer's number average MW of 5,200 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups.

Thus, acrylic acid-butyl acrylate-styrene copolymer meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to acrylic acid-butyl acrylate-styrene copolymer.

For the purposes of assessing potential exposure under this exemption, EPA considered that acrylic acid-butyl acrylate-styrene copolymer could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of acrylic acid-butyl acrylate-styrene copolymer is 5,200 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since acrylic acid-butyl acrylate-styrene copolymer conforms to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

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

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

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold 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 data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of acrylic acid-butyl acrylate-styrene copolymer, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of acrylic acid-butyl acrylate-styrene copolymer.

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

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

The Codex has not established a MRL for acrylic acid-butyl acrylate-styrene copolymer.

Accordingly, EPA finds that exempting residues of acrylic acid-butyl acrylate-styrene copolymer from the requirement of a tolerance will be safe.

This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). 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, 40 CFR chapter I is amended as follows:

I. Background

In FR Doc. 2016-18476 of August 22, 2016 (81 FR 56761) there were a number of technical and typographical errors identified and corrected in the Correction of Errors section of this correcting document. The provisions in this correcting document are effective as if they had been included in the document that appeared in the August 22, 2016 Federal Register. Accordingly, the corrections are effective October 1, 2016.

On page 56775, we made a typographical error in stating the cost reduction.

On page 56796, we are correcting errors and inadvertent omissions in the summary and response to a comment on the assignment of 18 additional diagnosis codes.

On page 56797, we erroneously referred to the wrong table.

On page 56801, we are correcting errors and inadvertent omissions in our response to comments on our proposal to redesignate four ICD-10-PCS procedure codes.

On page 56803 and in the table on page 56804 describing ICD-10-PCS Endovascular Thrombectomy Procedure Codes Reassigned to MS-DRGs 270, 271, and 272 for FY 2017, we are correcting technical errors in our discussion in response to comments to remove 34 ICD-10-PCS procedure codes describing endovascular thrombectomy of non-lower limbs from the proposed list of codes to be reassigned to MS-DRGs 270, 271 and 272. In this response, we erroneously referred to 34 procedure codes describing non-lower limb procedures (as included in the list submitted by the commenter) rather than 32 non-lower limb procedure codes. Two of the 34 procedure codes identified by the commenter, ICD-10-PCS procedure codes 04CT3ZZ (Extirpation of matter from right peroneal artery, percutaneous approach) and 04CU3ZZ (Extirpation of matter from left peroneal artery, percutaneous approach), describe endovascular thrombectomy of lower limbs. These codes are assigned to MS-DRGs 270, 271 and 272, accurately replicating the logic of ICD-9-CM MS-DRGs Version 32 and supporting clinical and resource use homogeneity as originally proposed and in accordance with the finalized policy to add procedures describing endovascular thrombectomy of lower limbs to ICD-10 Version 34 MS-DRGS 270, 271 and 272.

On page 56804, as a result of our correction of the MS-DRG assignment in Table 6B—New Procedure Codes for 13 ICD-10-PCS procedure codes that describe endovascular thrombectomy procedures of the lower limb, as described in section II.D. of this correction document, we are making additional conforming corrections to the table describing ICD-10-PCS Endovascular Thrombectomy Procedure Codes Reassigned to MS-DRGs 270, 271, and 272 for FY 2017.

On pages 56821 and 56823, we erroneously stated there were 58 additional combination codes for removal and replacement of knee joints. There were 57 additional combination codes.

On pages 56822 and 56823, we erroneously listed the code number for (Replacement of Left Knee Joint, Femoral Surface with Synthetic Substitute, Cemented, Open Approach) as code 0SRU0JA three times within the table. The correct code number should be 0SRU0J9 (Replacement of Left Knee Joint, Femoral Surface with Synthetic Substitute, Cemented, Open Approach).

As a result of the corrections to pages 56803, 56804, 56821, 56822, and 56823, we have made conforming changes to the ICD-10 MS-DRG Definitions Manual Version 34 and ICD-10 MS-DRG Grouper Software Version 34 for FY 2017.

On page 56858, we erroneously omitted MS-DRG 265 from the table of MS-DRGs subject to the policy for replaced devices offered without cost or with a credit.

On pages 56895 and 56897, we inadvertently made an error to the title of ICD-10-PCS procedure code XW03331 and omitted an additional procedure code that describes Idarucizumab. Cases involving Idarucizumab that are eligible for new technology add-on payments will be identified by ICD-10-PCS procedure codes XW03331 (Introduction of Idarucizumab, Dabigatran reversal agent into peripheral vein, percutaneous approach, New Technology Group 1) and XW04331 (Introduction of Idarucizumab, Dabigatran reversal agent into central vein, percutaneous approach, New Technology Group 1).

On page 56927, as a result of the correction of the technical errors described in section II.B of this correction document, we have made conforming changes to the following: The number of hospitals approved for wage index reclassifications by the Medicare Geographic Classification Review Board (MGCRB) starting in FY 2017 and the number of hospitals in a MGCRB reclassification status for FY 2017.

On page 57002 in the table titled, “Previously Adopted and Newly Finalized Baseline and Performance Periods for the FY 2021 Program Year” we erroneously repeated the same information three times, and in the first instance provided incorrect performance period years for the Mortality (MORT-30-AMI, MORT-30-HF, MORT-30-COPD) and THA/TKA measures.

On page 57033, we made a typographical error and omitted a dash within the web link address creating a non-functional link.

On pages 57195, 57196, 57199, 57211, 57213, 57218, and 57220 through 57223 we inadvertently made technical and typographical errors to the Long-Term Care Hospital Quality Reporting Program section and have corrected those errors for clarification.

As discussed in section II.D. of this correcting document, we made technical errors with regard to the calculation of Factor 3 of the uncompensated care payment methodology. The revisions made to address some of these errors directly affected and required the recalculation of all the budget neutrality factors and final outlier threshold. Factor 3 is used to determine the amount of total uncompensated care payment a hospital is eligible to receive as well as the amount of the uncompensated care payment a hospital receives per discharge. Per discharge uncompensated care payments are then included when determining total payments for purposes of all of the budget neutrality factors and the final outlier threshold. Therefore, we made conforming changes to pages 57278 through 57280, 57286, and 57291 to take into account the updated per-discharge uncompensated care payments determined using revised Factor 3 amounts. We made further conforming corrections to the national outlier adjustment factors on page 57286 and the table on page 57288 as a result of these changes. Finally, we made conforming corrections to the national operating standardized amounts.

We made inadvertent errors related to the MGCRB reclassification status of one provider as well as the status of three providers reclassified as urban to rural under section 1886(d)(8)(E) of the Act (codified in the regulations under § 412.103 and hereinafter referred to as § 412.103).

Specifically, the reclassification status in the FY 2017 IPPS/LTCH PPS final rule did not properly reflect the following:

• Withdrawal of a MGCRB reclassification for FY 2017 for one provider.

• Application of urban to rural reclassification under § 412.103 for three providers.

Therefore, on page 57279, we recalculated the reclassification hospital budget neutrality adjustment.

The reclassification errors also required the recalculation of additional budget neutrality adjustment factors, the fixed-loss cost threshold, the final wage indexes, and the national operating standardized amounts. Therefore, we made conforming changes to the following:

• On page 57280, the rural floor budget neutrality adjustment and the wage index transition budget neutrality adjustment.

• On page 57286, the calculation of the outlier fixed-loss cost threshold and the national outlier adjustment factors.

• On page 57288, the table titled “Change of FY 2016 Standardized Amounts to the FY 2017 Standardized Amounts”.

On pages 57291 and 57293 through 57295, in our discussion of the determination of the Federal hospital inpatient capital related prospective payment rate update, we have made conforming corrections to the increase in the capital Federal rate, the incremental and cumulative budget neutrality adjustment factors for changes in the GAFs and the MS-DRG relative weights, the GAF/MS-DRG budget neutrality adjustment factor (due to the errors in our calculation of the GAFs, which are computed from the wage index), the capital Federal rate, and the outlier threshold (as discussed previously).

Also, as a result of these errors, on pages 57294 and 57295, we have made conforming corrections in the tables showing the comparison of factors and adjustments for the FY 2016 capital Federal rate and FY 2017 capital Federal rate and the proposed FY 2017 capital Federal rate and final FY 2017 capital Federal rate.

On page 57307, we are making conforming corrections the fixed-loss amount for site neutral discharges due to corrections in the IPPS rates and factors discussed previously.

On page 57312, we have made conforming corrections to the national operating standardized amounts and capital standard Federal payment rate (which also include the rates payable to hospitals located in Puerto Rico) in Tables 1A, 1B, 1C, and 1D as a result of the conforming corrections to certain budget neutrality factors and the outlier threshold (as described previously).

On pages 57312, 57315 through 57317, 57319 through 57323, 57330 through 57332 in our regulatory impact analyses, we made conforming corrections to the factors, values, and tables and accompanying discussion of the changes in operating and capital IPPS payments for FY 2017 and the effects of certain budget neutrality factors as a result of the technical errors that lead to conforming changes in our calculation of the operating and capital IPPS budget neutrality factors, outlier threshold, final wage indexes, operating standardized amounts, and capital Federal rate (as described in section II.B. of this correction document).

On pages 57324 through 57326, in the table titled “Modeled Disproportionate Share Hospital Payments for Estimated FY 2017 DSHs by Hospital Type: Model DSH $ (In Millions) From FY 2016 To FY 2017” and the accompanying discussion, we made corrections to address technical and formatting errors in the estimated impacts resulting from inadvertent errors in the calculation of Factor 3 for certain hospitals.

On pages 57331 through 57332, we made conforming corrections to Table III—Comparison of Total Payments Per Case [FY 2016 Payments Compared to FY 2017 Payments].

On page 57342, we made conforming corrections to the discussion of the estimated changes in operating and capital IPPS payments and the accounting statement and table for acute care hospitals that arose from the corrections of errors and conforming changes as described in sections II.B. and II.D. of this correcting document.

We are correcting the errors in the following IPPS tables that are listed on page 57311 of the FY 2017 IPPS/LTCH PPS final rule and are available on the Internet on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2017-IPPS-Final-Rule-Home-Page.html. The tables that are available on the Internet have been updated to reflect the revisions discussed in this correcting document.

Table 2—Case-Mix Index and Wage Index Table—FY 2017. Because the uncompensated care and reclassification errors discussed in section II.B. of this correction document required that we recalculate the rural and imputed floor budget neutrality factor, we are correcting the values in the column titled FY 2017 Wage Index for all providers. For the three providers for which we are applying urban to rural reclassification under § 412.103, we are correcting the values in the column titled “FY 2017 Wage Index”, inserting the rural reclassified CBSA in the column titled “Reclassified/Redesignated CBSA”, and inserting a “Y” in the column titled “Hospital Reclassified as Rural Under Section 1886(d)(8)(E) of the Act (§ 412.103)”. For the provider that withdrew its MGCRB reclassification for FY 2017, we are revising the wage index in the column titled FY 2017 Wage Index, and we are removing the MGCRB flag in the column titled MGCRB Reclass.

Table 3—Wage Index Table by CBSA—FY 2017. Because the uncompensated care and reclassification errors discussed in section II.B. of this correction document required that we recalculate the rural and imputed floor budget neutrality factor, we are making corresponding changes to the wage indexes and GAFs of all CBSAs listed in Table 3. Specifically, we are correcting the values and flags in the columns titled “Wage Index”, “Reclassified Wage Index”, “GAF”, “Reclassified GAF”, “Pre-Frontier and/or Pre-Rural Floor Wage Index” and “Eligible for Rural Floor Wage Index”.

Table 6B—New Procedure Codes for FY 2017. In Table 6B—New Procedure Codes, we inadvertently listed the incorrect MS-DRG assignment for 13 ICD-10-PCS procedure codes that describe endovascular thrombectomy procedures of the lower limb involving a bifurcation. We are correcting the MS-DRG assignment of these 13 ICD-10-PCS codes in Table 6B.

Table 10—New Technology Add-On Payment Thresholds for Applications for FY 2018. We are correcting the thresholds in this table as a result of the corrections to the operating standardized amounts discussed in section II.B. of this correcting document.

Table 18—FY 2017 Medicare DSH Uncompensated Care Payment Factor 3 and Projected DSH Eligibility. For the FY 2017 IPPS/LTCH PPS final rule, we published a list of hospitals that we identified to be subsection (d) hospitals and subsection (d) Puerto Rico hospitals eligible to receive empirically justified Medicare DSH payment adjustments and uncompensated care payments for FY 2017. We also published, in the Supplemental Medicare DSH File located in the FY 2017 IPPS/LTCH PPS final rule data files page at https://www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/AcuteInpatientPPS/FY2017-IPPS-FinalRule-Home-Page-Items/FY2017-IPPSFinal-Rule-Data-Files.html, the data used to calculate each hospital's Factor 3, total uncompensated care payment, and estimated uncompensated care payment per discharge.

Shortly after the publication of the FY2017 IPPS/LTCH PPS final rule, we discovered that, in calculating Factor 3 of the uncompensated care payment methodology, we had understated the low-income insured days of hospitals that merged after 2011 with one surviving provider number because we inadvertently excluded the low income insured days of acquired hospitals from the low income insured days used in the Factor 3 calculation of surviving hospitals that were projected to receive Medicare DSH in FY 2017. In addition, we discovered that we had calculated a Factor 3 for hospitals that have ceased operations and erroneously calculated Factor 3 using Medicaid days reported on Worksheet S-3 instead of Worksheet S-2 of certain hospitals' FY 2013 cost reports. We are revising Factor 3 for all hospitals to correct these errors. These corrections to the uncompensated care payments impacted the calculation of all the budget neutrality factors as well as the outlier fixed-loss cost threshold for outlier payments.

In addition, we discovered that we had inadvertently excluded the Medicaid days from the 2011 cost report for a provider as well as the Medicaid days from the 2012 cost report for another provider from the calculation of Factor 3. Due to technical errors by our Medicare Administrative Contractors the Medicaid days from these cost reports were not included in the March 2016 update of HCRIS. We projected that both providers would be eligible to receive Medicare DSH in FY 2017. Accordingly, we are revising Factor 3 for all hospitals to reflect these Medicaid days; however, the impact of these revisions is too small to affect other aspects of the IPPS ratesetting, such as the calculation of the fixed-loss threshold for outlier payments.

We are also correcting the errors in the following LTCH PPS table that is listed on page 57311 of the FY 2017 IPPS/LTCH PPS final rule and is available on the Internet on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/LongTermCareHospitalPPS/index.html under the list item for regulation number CMS-1655-F. The table that is available on the Internet has been updated to reflect the revisions discussed in this correcting document.

Table 11—MS-LTC-DRGs, Relative Weights, Geometric Average Length of Stay, Short Stay Outlier (SSO) Threshold, and “IPPS Comparable Threshold” for LTCH PPS Discharges Occurring from October 1, 2016 through September 30, 2017. We are correcting this table by correcting typographical errors for MS-LTC-DRGs 627 and 658 in the columns titled “Relative Weight,” “Geometric Average Length of Stay,” “Short-Stay Outlier (SSO) Threshold,” and “IPPS Comparable Threshold.”

We ordinarily publish a notice of proposed rulemaking in the Federal Register to provide a period for public comment before the provisions of a rule take effect in accordance with section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). However, we can waive this notice and comment procedure if the Secretary finds, for good cause, that the notice and comment process is impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and the reasons therefore in the notice.

Section 553(d) of the APA ordinarily requires a 30-day delay in the effective date of final rules after the date of their publication in the Federal Register. This 30-day delay in effective date can be waived, however, if an agency finds for good cause that the delay is impracticable, unnecessary, or contrary to the public interest, and the agency incorporates a statement of the findings and its reasons in the rule issued.

We believe that this correcting document does not constitute a rule that would be subject to the APA notice and comment or delayed effective date requirements. This correcting document corrects technical and typographic errors in the preamble, addendum, payment rates, tables, and appendices included or referenced in the FY 2017 IPPS/LTCH PPS final rule but does not make substantive changes to the policies or payment methodologies that were adopted in the final rule. As a result, this correcting document is intended to ensure that the information in the FY 2017 IPPS/LTCH PPS final rule accurately reflects the policies adopted in that final rule.

In addition, even if this were a rule to which the notice and comment procedures and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the final rule or delaying the effective date would be contrary to the public interest because it is in the public's interest for providers to receive appropriate payments in as timely a manner as possible, and to ensure that the FY 2017 IPPS/LTCH PPS final rule accurately reflects our policies. Furthermore, such procedures would be unnecessary, as we are not altering our payment methodologies or policies, but rather, we are simply implementing correctly the policies that we previously proposed, received comment on, and subsequently finalized. This correcting document is intended solely to ensure that the FY 2017 IPPS/LTCH PPS final rule accurately reflects these payment methodologies and policies. Therefore, we believe we have good cause to waive the notice and comment and effective date requirements.

In FR Doc. 2016-18476 of August 22, 2016 (81 FR 56761), we are making the following corrections:

1. On page 56775, third column, second bulleted paragraph, line 25, the figure “$50.4 million” is corrected to read “$56.4 million”.

2. On page 56796—

a. Top half of the page, third column, third full paragraph,

(1) Lines 4 and 5, the phrase “describing similar conditions” is corrected to read “displayed in Table 6A—New Diagnosis Codes associated with the proposed rule (which is available via the Internet on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html) that describe similar conditions”.

(2) Lines 9 and 10, the phrase, “18 ICD-10-CN diagnosis codes in the following table be reassigned” is corrected to read “18 ICD-10-CM diagnosis codes in the following table also be reassigned”.

b. Lower half of the page, first column, last paragraph—

(1) Lines 6 and 7, the phrase “describing procedures performed on” is corrected to read “describing conditions affecting”.

(2) Line 14, the phrase “MS DRGs 091, 092 and 093.” is corrected to read “MS-DRGs 091, 092, and 093 because they are also nervous system codes.”

3. On page 56797, first column, first paragraph, lines 15 and 16, the phrase “These 18 codes also are reflected in Table 6E” is corrected to read “These 18 codes are reflected in Table 6A”.

4. On page 56801, second column, second full paragraph—

a. Lines 11 and 12, the phrase “performing such procedures because loop” is corrected to read “performing such procedures because, as noted in the FY 2017 IPPS/LTCH PPS proposed rule, loop”.

b. Lines 25 and 26, the phrase “were not able to finalize that specific request.” is corrected to read “were not able to replicate that specific request in the ICD-9-CM based MS-DRGs.”.

c. Lines 26 through 29, the sentence “Rather, we finalized an alternative option, which was to change the designation for four of the six codes requested.” is corrected to read “Rather, we proposed an alternative option, which was to change the designation for four of the six codes requested, because we believed that if we limited the change in designation to these four codes, the change would not have any impact.”.

d. Lines 40 through 41, the phrase “not finalizing the proposal to change the two” is corrected to read “not changing the designation of the two”.

5. On page 56803, bottom of the page—

a. First column, last paragraph, lines 7 and 8, the phrase “removing the 34 codes” is corrected to read “removing 32 of the 34 codes”.

b. Second column, first partial paragraph—

(1) Lines 5 and 6, the phrase “34 non-lower” is corrected to read “32 non-lower”.

(2) Lines 8 and 9, the phrase “These 34 non-lower” is corrected to read “These 32 non-lower”.

(3) Line 13, after the phrase “for FY 2017.” the paragraph is corrected by adding sentences to read as follows:

“Two of the procedure codes identified by the commenter, ICD-10-PCS procedure codes 04CT3ZZ (Extirpation of matter from right peroneal artery, percutaneous approach) and 04CU3ZZ (Extirpation of matter from left peroneal artery, percutaneous approach) describe endovascular thrombectomy of lower limbs and are not non-lower limb procedure codes.”.

c. Third column, first full paragraph, line 11, the phrase “34 procedure” is corrected to read “32 procedure”.

6. On page 56804, top of page, the table titled “ICD-10-PCS ENDOVASCULAR THROMBECTOMY PROCEDURE CODES REASSIGNED TO MS-DRGs 270, 271, AND 272 FOR FY 2017” is corrected by adding the following entries:

7. On page 56821, middle of the page—

a. Second column, first partial paragraph, line 2, the phrase “identified 58” is corrected to read “identified 57”.

b. Third column, first partial paragraph, line 3, the phrase “following 58” is corrected to read “following 57”.

8. On pages 56821 through 56823, in the table titled “ICD-10-PCS CODE PAIRS PROPOSED TO BE ADDED TO VERSION 34 ICD-10 MS-DRGs 466, 467, and 468: PROPOSED NEW KNEE REVISION ICD-10-PCS COMBINATIONS”, the codes (in the 4th column) for the following entries are corrected to read as follows:

9. On page 56823, lower half of the page—

a. First column, second paragraph, line 10, the phrase “58 new” is corrected to read “57 new”.

b. Second column—

(1) First partial paragraph, line 11, the phrase “58 new” is corrected to read “ new”.

(2) First full paragraph, lines 3 and 4, the phrase “58 new” is corrected to read “57 new”.

10. On page 56858, top of the page, the untitled table is corrected by adding the following entry after line 34 (which is the entry for MDC 5, MS-DRG 262):

11. On page 56895, third column, first partial paragraph—

a. Lines 8 and 9, the phrase “a unique ICD-10-PCS procedure code” is corrected to read “two unique ICD-10-PCS procedure codes”.

b. Lines 10 through 15, the sentence “The approved procedure code is XW0331 (Introduction of Idarucizumab, Dabigatran reversal agent into central vein, percutaneous approach, New Technology Group 1).” is corrected to read “The approved procedure codes are XW0331 (Introduction of Idarucizumab, Dabigatran reversal agent into peripheral vein, percutaneous approach, New Technology Group 1) and XW04331 (Introduction of Idarucizumab, Dabigatran reversal agent into central vein, percutaneous approach, New Technology Group 1).”.

12. On page 56897, third column, third full paragraph, line 11, the phrase “procedure code XW03331.” is corrected to read “procedure codes XW03331 and XW04331.”.

13. On page 56927—

a. Second column, last partial paragraph, line 5 the phrase “265 hospitals” is corrected to read “264 hospitals”.

b. Third column, first partial paragraph, line 12, the phrase “817 hospitals” is corrected to read “816 hospitals”.

14. On page 57002, bottom of the page, the table titled “PREVIOUSLY ADOPTED AND NEWLY FINALIZED BASELINE AND PERFORMANCE PERIODS FOR THE FY 2021 PROGRAM YEAR” is corrected to read as follows:

15. On page 57033, first column, last paragraph, lines 2 through 4, the web link “http://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/dgme.html” is corrected to read “http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/dgme.html.”

16. On page 57195—

a. First column, last partial paragraph, lines 4 and 5, the phrase “it recommended” is corrected to read “the commenters recommended”.

b. Third column, third full paragraph—

(1). Line 14, the phrase “This measure” is corrected to read “The Drug Regimen Review Conducted with Follow-Up for Identified Issues-PAC LTCH QRP quality measure”.

(2) Lines 23 through 25, the phrase “ and Potentially Preventable 30-Day Post-Discharge Readmission Measure for LTCH QRP,” is corrected to read “, Potentially Preventable 30-Day Post-Discharge Readmission Measure for LTCH QRP and Medicare Spending Per Beneficiary-PAC LTCH QRP,”.

17. On page 57196, third column, first full paragraph, lines 13 through 16, the phrase “with information more frequently, such as unadjusted counts of potentially preventable readmissions (PPRs) and discharge data.” is corrected to read “with information, such as unadjusted counts of potentially preventable readmissions (PPRs) and discharge data, more frequently.”

18. On page 57199, first column, second full paragraph, lines 3 and 4, the phrase “SES or SDS status.” is corrected to read “SES or SDS.”

19. On page 57211, third column, second full paragraph, line 16, the phrase “to discharge” is corrected to read “to be discharged”.

20. On page 57213—

a. Second column, last partial paragraph, lines 6 through 8, the phrase “and a SNF stay within a 30-day window, the SNF stay is a candidate to for” is corrected to read “and then a SNF stay within a 30-day window, the SNF stay is a candidate for”.

b. Third column, after the last paragraph, Footnote 280, lines 1 and 2, the measure name “Hospital-Wide All-Cause Readmission Measure (HWR) (CMS/Yale).” is corrected to read “Hospital-Wide All-Cause Unplanned Readmission Measure (HWR) (CMS/Yale).”

21. On page 57218, third column, first full paragraph, lines 4 and 5, the phrase “The commenter was correct in its interpretation of” is corrected to read “The commenter's interpretation was correct regarding”.

22. On page 57220, second column, second footnoted full paragraph (Footnote 311), lines 1 through 6, the footnote “311Greenwald, J.L., Halasyamani, L., Greene, J., LaCivita, C., et al. (2010). Making inpatient medication reconciliation patient centered, clinically relevant and implementable: A consensus statement on key principles and necessary first steps. Journal of Hospital Medicine, 5(8), 477-485.” is corrected to read “311Institute of Medicine. Preventing Medication Errors. Washington, DC: National Academies Press; 2006.”

23. On page 57221, second column, second full paragraph, lines 3 and 4, the phrase “cross-setting and quality measure” is corrected to read “cross-setting quality measure”.

24. On page 57222—

a. Second column, first full paragraph, lines 11 and 12, the phrase “however, the adoption of the measure” is corrected to read “however, the measure”.

b. Third column, first full paragraph—

(1) Line 4, the word “facilities” is corrected to read “facility's”.

(2) Line 22, the phrase “collected admission” is corrected to read “collected at admission”.

25. On page 57223—

a. First column, second paragraph—

(1) Lines 1 through 4, the phrase “Since the time of the MAP consideration, with our measure contractor, we tested this measure in a pilot test involving twelve PAC facilities,” is corrected to read “Since the time of the NQF-convened MAP consideration we have further tested this measure in a pilot test involving twelve PAC facilities”.

(2) Lines 7 and 8, the phrase, “record collection system” is corrected to read “records system”.

b. Second column, third full paragraph, lines 9 and 10, the phrase “PAC facility.” is corrected to read “PAC facility. We appreciate MedPAC and other commenters' recommendation for a quality measure that assesses post-discharge medication communication with primary care providers for patients discharged to home.”

1. On page 57278, third column, fifth full paragraph,

a. Line 3, the figure “0.999079” is corrected to read “0.999078”.

b. Line 9, the figure “0.999079” is corrected to read “0.999078”.

2. On page 57279—

a. Second column, first full paragraph, line 9, the figure “1.000209” is corrected to read “1.00021”.

b. Third column, third full paragraph, line 12, the figure “0.988224” is corrected to read “0.988136”.

3. On page 57280—

a. First column, fifth full paragraph, line 4, the figure “0.993200” is corrected to read “0.991987”.

b. Third column, second full paragraph,

(1) Line 3, the figure “0.999994” is corrected to read “0.999997”.

(2) Line 6, the figure “0.999994” is corrected to read “0.999997”.

4. On page 57286—

a. Second column, last paragraph—

(1) Line 6, the figure “$23,570” is corrected to read “$23,573”.

(2) Line 8, the figure “$83,347,416,971” is corrected to read “$83,364,479,923”.

(3) Line 9, the figure “$4,479,256,519” is corrected to read “$4,479,256,368”.

b. Third column—

(1) First partial paragraph, line 11, the figure “$23,570” is corrected to read “$23,573”.

(2) Following the third full paragraph, the untitled table is corrected to read as follows:

5. On page 57288, middle of the page, the table titled “CHANGE OF FY 2016 STANDARDIZED AMOUNTS TO THE FY 2017 STANDARDIZED AMOUNTS”, is corrected to read as follows:

6. On page 57291—

a. First column, second full paragraph, line 15, the figure “0.999079” is corrected to read “0.999078”.

b. Third column, first full paragraph line 6, the figure “1.84” is corrected to read “1.83”.

7. On page 57293, third column—

a. First partial paragraph—

(1) Line 1, the figure “0.9995” is corrected to read “0.9994”.

(2) Line 4, “0.9855” is corrected to read “0.9854”.

b. First full paragraph, line 16, the figure “0.9851” is corrected to read “0.9850”.

c. Last paragraph—

(1) Line 2, the figure “0.9991”is corrected to read “0.9990”.

(2) Line 4, “0.9995” is corrected to read “0.9994”.

8. On page 57294—

a. Top of the page—

(1) Second column—

(a) First full paragraph, line 17, the figure “$446.81” is corrected to read “$446.79”.

(b) Second bulleted paragraph, line 6, the figure “0.9991” is corrected to read “0.9990”.

(2) Third column, second full paragraph—

(a) Line 13, the figure, “0.09” is corrected to read “0.10”.

(b) Line 26, the figure, “1.84” is corrected to read “1.832”.

b. Bottom of the page, the table titled “COMPARISON OF FACTORS AND ADJUSTMENTS: FY 2016 CAPITAL FEDERAL RATE AND FY 2017 CAPITAL FEDERAL RATE” is corrected to read as follows:

9. On page 57295—

a. The top of the page, the table titled “COMPARISON OF FACTORS AND ADJUSTMENTS: PROPOSED FY 2017 CAPITAL FEDERAL RATE AND FINAL FY 2017 CAPITAL FEDERAL RATE” is corrected to read as follows:

b. Lower three-fourths of the page, first column, second paragraph, line 21, the figure, “$23,570.” is corrected to read “$23,573.”

10. On page 57307, second column, first full paragraph—

a. Line 15, the figure “$23,570” is corrected to read “$23,573”.

b. Line 35, the figure “$23,570” is corrected to read “$23,573”.

11. On page 57312—

a. Top of the page—

(1) Table 1A titled “NATIONAL ADJUSTED OPERATING STANDARDIZED AMOUNTS, LABOR/NONLABOR (69.6 PERCENT LABOR SHARE/30.4 PERCENT NONLABOR SHARE IF WAGE INDEX IS GREATER THAN 1)—FY 2017” is corrected to read as follows:

(2) Table 1B titled “NATIONAL ADJUSTED OPERATING STANDARDIZED AMOUNTS, LABOR/NONLABOR (62 PERCENT LABOR SHARE/38 PERCENT NONLABOR SHARE IF WAGE INDEX IS LESS THAN OR EQUAL TO 1)—FY 2017” is corrected to read as follows:

b. Middle of the page—

(1) Table 1C titled “ADJUSTED OPERATING STANDARDIZED AMOUNTS FOR HOSPITALS IN PUERTO RICO, LABOR/NONLABOR (NATIONAL: 62 PERCENT LABOR SHARE/38 PERCENT NONLABOR SHARE BECAUSE WAGE INDEX IS LESS THAN OR EQUAL TO 1);—FY 2017” is corrected to read as follows:

(2) Table 1D titled “CAPITAL STANDARD FEDERAL PAYMENT RATE—FY 2017” is corrected as follows:

1. On page 57312, bottom of the page, third column, first partial paragraph,

a. Line 8, the figure “$987” is corrected to read “$990”.

b. Line 10, the figure “$66” is corrected to read “$72”.

2. On page 57315, upper three-fourths of the page—

a. Second column, third full paragraph,

(1) Line 7, the figure “1,380” is corrected to read “1,369”.

(2) Line 9, the figure “1,135” is corrected to read “1,146”.

b. Third column, first full paragraph, line 13—

(1) The figure “1,372” is corrected to read “1,369”.

(2) The figure “1,150” is corrected to read “1,153”.

3. On pages 57315 through 57317, the table titled “TABLE I—IMPACT ANALYSIS OF CHANGES TO THE IPPS FOR OPERATING COSTS FOR FY 2017” is corrected to read as follows:

4. On page 57319,

a. First column, second full paragraph,

(1) Line 6, the figure “0.988224” is corrected to read “0.988136”.

(2) Line 13, the figure “1.4” is corrected to read “1.3”.

b. Second column—

(1) First full paragraph—

(a) Line 8, the figure “0.9930” is corrected to read “0.991987”.

(b) Line 9, the figure “0.7” is corrected to read “0.8”.

(2) Third full paragraph—

(a) Line 1, the figure “397” is corrected to read “436”.

(b) Line 5—

(1) The figure “0.9930” is corrected to read “0.991987”.

(2) The figure “0.7” is corrected to read “0.8”.

(c) Line 23, the figure “1.0” is corrected to read “0.9”.

(d) Line 31, the figure “$24” is corrected to read “$22”.

(e) Line 33, the figure “0.7” is corrected to read “0.6”.

c. Third column—

(1) First full paragraph,

(a) Line 7, the figure “$10” is corrected to read “$6.4”.

(b) Line 18, the figure “$17” is corrected to read “$18”.

(2) Second full paragraph, line 28, the figure “0.999994” is corrected to read “0.999997”.

5. On page 57320, the table titled “FY 2017 IPPS Estimated Payments Due to Rural Floor and Imputed Floor with National Budget Neutrality” is corrected to read as follows:

6. On page 57321, second column, first partial paragraph —

a Line 1, the figure “277” is corrected to read “278”.

b Line 7, the figure “1.0” is corrected to read “0.9”.

7. On pages 57321 through 57323, the table titled “TABLE II—IMPACT ANALYSIS OF CHANGES FOR FY 2017 ACUTE CARE HOSPITAL OPERATING PROSPECTIVE PAYMENT SYSTEM [PAYMENTS PER DISCHARGE]” is corrected to read as follows:

7. On page 57324, top of the page, third column, last paragraph, line 1, the figure “2,426” is corrected to read “2,419”.

8. On pages 57324 and 57325, the table titled “Modeled Disproportionate Share Hospital Payments for Estimated FY 2017 DSHs by Hospital Type: Model DSH $ (In Millions) From FY 2016 to FY 2017” is corrected to read as follows:

9. On page 57325, bottom of the page, third column, last paragraph, line 8, the figure “6.4” is corrected to read “5.9”.

10. On page 57326, first column—

a. First partial paragraph—

(1) Line 7 the figure “5.2” is corrected to read “5.5”.

(2) Line 8, the figure “5.9” is corrected to read “0.2”.

b. First full paragraph, line 12, the figure “11.4” is corrected to read “11.3”.

c. Third full paragraph (last paragraph)—

(1) Line 12, the figure “11.4” is corrected to read “11.3”.

(2) Line 18, the figure “$9.5 million” is corrected to read “$9.4 million”.

11. On page 57330, third column—

a. Fourth bulleted paragraph, line 4, the figure “0.9991” is corrected to read “0.9990”.

b. Last paragraph, line 6, the figure “1.84” is corrected to read “1.83”.

12. On page 57331, top half of the page—

a. First column—

(1) First partial paragraph—

(a) Line 1, the phrase “Less than half of the hospitals” is corrected to read “Most of the hospitals”.

(b) Lines 4 through 6, the phrase “the effects of changes to the GAFs, while the remainder of these urban area hospitals would experience no change or a decrease in” is corrected to read “the effects of changes to the GAFs, while hospitals in one urban area are expected to experience a decrease in”.

(c) Line 11, the phrase “except for two rural areas where changes in” is corrected to read, “except for one rural area where changes in”.

(2) Third paragraph, lines 8 and line 9, the phrase “0.7 percent, while hospitals in rural areas, on average, are expected to experience a 0.8” is corrected to read “0.7 percent, and hospitals in rural areas, on average, are also expected to experience a 0.7”.

b. Second column—

(1) First partial paragraph, lines 2 through 6, the sentence “The primary factor contributing to the small difference in the projected increase in capital IPPS payments per case for urban hospitals as compared to rural hospitals is the changes to the GAFs.” is corrected by deleting the sentence.

(2) First full paragraph—

(a) Lines 4 through 8, “range from a 4.2 percent increase for the Puerto Rico urban hospitals, and a 1.4 percent increase for the West South Central urban region to a 0.7 percent increase for the Mountain urban region.” is corrected to read “range from a 4.1 percent increase for the Puerto Rico urban hospitals, and a 2.1 percent increase for the Mountain urban region to a 0.7 percent increase for several other urban regions.”.

(b) Line 13, the figure “4.2” is corrected to read “4.1”.

(c) Line 23, the figure “1.6” is corrected to read “2.1”.

(d) Line 26, the figure “0.4” should read “0.1”.

c. Third column—

(1) First full paragraph, line 9, the figure “0.7” is corrected to read “0.6”.

(2) Second full paragraph—

(a) Line 13, the figure “1.0” is corrected to read “0.9”.

(b) Line 17, the figure “1.0” is corrected to read “0.9”.

(c) Line 20, the figure “0.2” is corrected to read “0.3”.

13. On pages 57331 and 57332, the table titled “Table III.—Comparison of Total Payments Per Case [FY 2016 Payments Compared To FY 2017 Payments]” is corrected to read as follows:

14. On page 57342—

a. Top of the page—

(1) First column, first full paragraph—

(a) Line 11, the figure “987” is corrected to read “990”.

(b) Line 23, the figure “809” is corrected to read “811”.

(2) Second column, first partial paragraph—

(a) Line 12, the figure “809” is corrected to read “811”.

(b) Line 14, the figure”680” is corrected to read “683”.

(c) Line 19, the figure “66” is corrected to read “72”.

(d) Line 23, the figure “746” is corrected to read “755”.

b. Middle of the page, the table titled “TABLE V—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES UNDER THE IPPS FROM FY 2016 TO FY 2017” is corrected to read as follows:

Executive Summary

Why we need to publish a rule. Under the Endangered Species Act (Act), we may list a species if it is endangered or threatened throughout all or a significant portion of its range. Listing a species as an endangered or threatened species can only be completed by issuing a rule.

What this document does. This rule finalizes the listing of the Kentucky arrow darter (Etheostoma spilotum) as a threatened species. It also includes provisions published under section 4(d) of the Act that are necessary and advisable for the conservation of the Kentucky arrow darter.

The basis for our action. Under the Act, we may determine that a species is an endangered or threatened species based on any of five factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. This decision to list the Kentucky arrow darter as threatened is based on three of the five factors (A, D, and E).

Under section 4(d) of the Act, the Secretary of the Interior has discretion to issue such regulations as she deems necessary and advisable to provide for the conservation of threatened species. The Secretary also has the discretion to prohibit by regulation, with respect to a threatened species, any act prohibited by section 9(a)(1) of the Act.

Summary of the major provisions of the 4(d) rule. The regulations in title 50 of the Code of Federal Regulations at 50 CFR 17.31(a) apply to threatened wildlife all the general prohibitions for endangered wildlife set forth at 50 CFR 17.21, and 50 CFR 17.31(c) states that whenever a 4(d) rule applies to a threatened species, the provisions of § 17.31(a) do not apply to that species. The regulations at 50 CFR 17.32 contain permit provisions for threatened species.

Some activities that would normally be prohibited under 50 CFR 17.31 and 17.32 will contribute to the conservation of the Kentucky arrow darter because habitat within some of the physically degraded streams must be improved before they are suitable for the species. Therefore, the Service has authorized certain species-specific exceptions for the Kentucky arrow darter under section 4(d) of the Act that may be appropriate to promote the conservation of this species. This 4(d) rule also exempts from the general prohibitions in 50 CFR 17.32 take that is incidental to the following activities when conducted within habitats currently occupied by the Kentucky arrow darter:

(1) Channel reconfiguration or restoration projects that create natural, physically stable, ecologically functioning streams (or stream and wetland systems) that are reconnected with their groundwater aquifers.

(2) Bank stabilization projects that use bioengineering methods specified by the Kentucky Energy and Environment Cabinet and the Kentucky Transportation Cabinet.

(3) Bridge and culvert replacement/removal projects that remove migration barriers (e.g., collapsing, blocked, or perched culverts) or generally allow for improved upstream and downstream movements of Kentucky arrow darters.

(4) Repair and maintenance of U.S. Forest Service (USFS) concrete plank stream crossings in the Daniel Boone National Forest (DBNF).

Peer review and public comment. We sought comments from independent specialists to ensure that our listing determination is based on scientifically sound data, assumptions, and analyses. We invited these peer reviewers to comment on our listing proposal. We also considered all comments and information received during the comment period.

Elsewhere in this Federal Register, we finalize designation of critical habitat for the Kentucky arrow darter under the Act.

Please refer to the proposed listing rule for the Kentucky arrow darter (80 FR 60962, October 8, 2015) for a detailed description of previous Federal actions concerning this species.

In the proposed rule published on October 8, 2015 (80 FR 60962), we requested that all interested parties submit written comments on the proposal by December 7, 2015. 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 the Lexington Herald-Leader and Louisville Courier Journal. We did not receive any requests for a public hearing. During the comment period, we received 47 comment letters in response to the proposed rule: 5 from peer reviewers, 1 from a State agency, and 41 from organizations or individuals. Two comment letters from organizations were accompanied by petitions containing a total of 15,388 signatures of persons supporting the proposed listing. Another organization submitted a separate comment letter on behalf of itself and 14 other organizations. None of the 47 comment letters objected to the proposed rule to list the Kentucky arrow darter as threatened. All substantive information provided during the comment period has either been incorporated directly into this final determination or addressed below.

In accordance with our peer review policy published on July 1, 1994 (59 FR 34270), we solicited expert opinion from seven knowledgeable individuals with scientific expertise that included familiarity with Kentucky arrow darter and its habitat, biological needs, and threats. We received responses from five of the peer reviewers.

We reviewed all comments received from the peer reviewers for substantive issues and new information regarding the listing of Kentucky arrow darter. The peer reviewers all generally concurred with our methods and conclusions and provided additional information on the taxonomy, life history, and threats; technical clarifications; and suggestions to improve the final rule. The comments and supplementary information provided by the peer reviewers improved the final version of this document, and we thank them for their efforts. Peer reviewer comments are addressed in the following summary and incorporated into the final rule as appropriate.

(1) Comment: One peer reviewer stated that the Service should include any new information on growth, feeding, reproduction, or spawning of the Kentucky arrow darter obtained from recent captive-propagation efforts by Conservation Fisheries, Inc. (CFI) in Knoxville, Tennessee.

Our Response: New observations on spawning behavior and the growth and viability of eggs and larvae were made by CFI during recent captive-propagation efforts (2010 to present). We have incorporated language summarizing these findings under the Background—Habitat and Life History section of this final listing determination.

(2) Comment: Two of the peer reviewers asked that we discuss the detectability of the Kentucky arrow darter during survey efforts and how this could affect our conclusions regarding the status of the species. More specifically, the peer reviewers raised the issue of imperfect detection, which is the inability of the surveyor to detect a species (even if present) due to surveyor error, low-density or rareness of the target species, or confounding variables such as environmental conditions (e.g., stream flow). The peer reviewers asked the Service to explain how it accounted for imperfect detection when evaluating the species' current distribution and status.

Our Response: We recognize the importance and significance of imperfect detection when conducting surveys for rare or low-density species, and we agree that is possible a species can go undetected within a particular survey reach when it is actually present. However, we are also required, by statute and regulation, to base our determinations solely on the basis of the best scientific and commercial data available. We are confident that the survey data available to us at the time we prepared our proposed listing determination represented the best scientific and commercial data available. These data were collected by well-trained, professional biologists, who employed similar sampling techniques (single-pass electrofishing) across the entire potential range of the Kentucky arrow darter, which included historical darter locations, random locations, and locations associated with regulatory permitting, such as mining or transportation. Nearly 245 surveys were conducted for the species between 2007 and 2015, and the results of these surveys revealed a clear trend of habitat degradation and range curtailment for the species. Kentucky arrow darters may have gone undetected at a few sites (i.e., our detection of the species may have been imperfect at a few collection sites), but the species' overall decline and pattern of associated habitat degradation (e.g., elevated conductivity) was clear based on our review of available survey data.

(3) Comment: One peer reviewer pointed out that some information we included on the reproductive behavior of the Kentucky arrow darter was actually based on research conducted on its closest relative, the Cumberland arrow darter (Etheostoma sagitta).

Our Response: We concur with the peer reviewer and have incorporated language to address this topic under the Background—Habitat and Life History section of this final listing determination.

(4) Comment: Two peer reviewers suggested we expand our discussion of the effects of elevated conductivity on aquatic communities by including additional information related to the vulnerability of salamanders or other aquatic organisms.

Our Response: We have added language to address this topic under the Factor A. The Present or Threatened Destruction, Modification, or Curtailment of its Habitat or Range—Water Quality Degradation section of this final listing determination.

(5) Comment: One peer reviewer recommended we discuss the potential threat posed by anthropogenic barriers (e.g., perched culverts).

Our Response: We added language to address this topic under the Factor E. Other Natural or Manmade Factors Affecting Its Continued Existence—Restricted Range and Population Size section of this final listing determination.

(6) Comment: One peer reviewer suggested that the spatial degree of impacts facing the Kentucky arrow darter could be more accurately estimated using the Kentucky Division of Water's probabilistic sampling data from the upper Kentucky River basin, as opposed to relying on data generated from fixed monitoring sites across the species' range.

Our Response: We agree with the peer reviewer and have added language to address this topic under the Factor A. The Present or Threatened Destruction, Modification, or Curtailment of its Habitat or Range section of this final listing determination.

(7) Comment: One peer reviewer offered new information on gill parasites and sewage bacteria, suggesting that these organisms represent potential threats to the Kentucky arrow darter under Factor C. Disease or Predation.

Our Response: We agree with the peer reviewer that these organisms have the potential to adversely affect the Kentucky arrow darter, and we have added language to address this topic under the Factor C. Disease or Predation section of this final listing determination.

(8) Comment: One peer reviewer commented that generalized natural channel design projects (i.e., Rosgen) may not be sufficient under provisions of the proposed section 4(d) rule, and individual designs would be needed to benefit the Kentucky arrow darter.

Our Response: In the proposed listing determination, we proposed a species-specific section 4(d) rule to further promote the conservation of the Kentucky arrow darter. We concluded that activities such as stream reconfiguration/riparian restoration, bridge and culvert replacement or removal, bank stabilization, and stream crossing repair and maintenance would improve or restore physical habitat quality for the species and would provide an overall conservation benefit to the species. We concur with the peer reviewer that, under the proposed 4(d) rule, generalized stream restoration designs may not be sufficient to benefit the species. For this reason, the Service provided references and detailed descriptions of stream reconfigurations in the proposed rule, with an emphasis on stability, ecological function, and reconnection with groundwater systems.

(9) Comment: One peer reviewer and one other commenter stated that the Service needed to clarify potentially conflicting statements regarding threats under Factor D (the inadequacy of the Surface Mining Control and Reclamation Act (SMCRA) as an existing regulatory mechanism) and our conclusion that surface coal mining and reclamation activities conducted in accordance with the 1996 biological opinion (1996 BO) between the Service and the Office of Surface Mining Reclamation and Enforcement (OSM) are unlikely to result in a violation of section 9 of the Act.

Our Response: The peer reviewer and commenter are correct in stating that we considered existing regulatory mechanisms such as SMCRA to be inadequate in protecting the Kentucky arrow darter and its habitats. Habitats across the species' range have been degraded by water pollution and sedimentation associated with coal mining (e.g., elevated conductivity), and there is evidence of recent extirpations in watersheds impacted by mining (16 historical streams since the mid-1990s).

In the Provisions of the 4(d) Rule section of the proposed listing rule, we also stated that surface coal mining and reclamation activities, if conducted in accordance with existing regulations and permit conditions, would not result in violations of section 9 of the ESA. The 1996 BO is the result of a formal section 7 consultation between OSM and the Service on OSM's approval of State regulatory programs (primacy) under SMCRA. In Kentucky, the State has approved primacy under SMCRA and, therefore, operates under the 1996 BO to address adverse effects to federally listed species. Under the 1996 BO, SMCRA regulatory authorities are exempt from prohibitions of section 9 of the ESA if they comply with the terms and conditions of the 1996 BO. The terms and conditions of the 1996 BO require that each SMCRA regulatory authority implement and comply with species-specific protective measures for federally listed species as developed by the Service and the regulatory authority. These measures may not eliminate all adverse effects (“take”) on the species or its habitat, but they are intended to minimize and avoid impacts to the greatest extent practical and to ensure that the proposed activity will not jeopardize the species' continued existence.

(10) Comment: One peer reviewer stated the Service needs to coordinate with other agencies on protective conductivity levels under Kentucky's narrative aquatic life standards in order to protect the species.

Our Response: We continue to share information with the Kentucky Department of Environmental Protection (KYDEP) on the species' status and threats; however, any future modifications to Kentucky's narrative aquatic life standards will be the responsibility of KYDEP and the U.S. Environmental Protection Agency (USEPA). We will continue to provide technical assistance when requested.

(11) Comment: One peer reviewer commented that the Service should explain if recorded Kentucky arrow darter movements in Elisha Branch, Long Fork, and Hector Branch represent simple movements within home ranges (intrapopulational movements from pool to pool) or dispersal events (interpopulational movements).

Our Response: We can only speculate as to whether the recorded movements in these streams represent simple movements within home ranges or dispersal events. Most are likely intrapopulational (pool to pool within the same stream), but a few observations on Elisha Creek and Long Fork may provide evidence of dispersal events (interpopulational). We have added language to address this topic under the Background—Habitat and Life History section of this final listing determination.

(12) Comment: One peer reviewer stated that the Service should explain how we estimated abundance and recruitment of Kentucky arrow darters.

Our Response: Kentucky arrow darter abundance per sampling reach was estimated based on observed captures during single-pass electrofishing surveys. As described in the proposed rule, these surveys typically involved qualitative searches of all available habitats within a 100- to 150-meter survey reach. Evidence of recruitment was based on the presence of multiple age-classes within a survey reach. All captured Kentucky arrow darters were measured (total length in millimeters), allowing for the discrimination of age classes.

(13) Comment: One peer reviewer stated that the Service did not mention or discuss the relationship between land use and instream habitat conditions.

Our Response: We do not specifically mention the influence of land use and how it relates to instream habitat conditions; however, the Factor A discussion offers multiple examples of how differing land uses (e.g., resource extraction, residential development) can affect water quality and physical habitat conditions.

(14) Comment: One peer reviewer asked us to clarify whether the Kentucky arrow darter was sensitive to high light conditions (loss of riparian vegetation and stream canopy).

Our Response: Increased light conditions have been shown to be a threat to other aquatic organisms, but its impact on the Kentucky arrow darter is unknown. We have added language to address this topic under the Factor A. The Present or Threatened Destruction, Modification, or Curtailment of its Habitat or Range section of this final listing determination.

(15) Comment: One peer reviewer commented that nonnative rainbow trout may compete with Kentucky arrow darters for food resources and space.

Our Response: Within Big Double Creek, the only stream occupied by both species, nonnative rainbow trout and Kentucky arrow darters could complete for food and space as both feed on aquatic insects and both occupy similar habitats (pools). However, we do not believe that competition from nonnative trout represents a widespread, high-magnitude threat to the species across its range. Potential competition from nonnative trout is limited to Big Double Creek, and recent surveys in Big Double Creek demonstrate that the Kentucky arrow darter population is healthy and stable (see Factor C: Disease or Predation).

(16) Comment: One peer reviewer, the Kentucky Division of Forestry, and several other commenters provided comments on the effectiveness of best management practices (BMP) and compliance issues related to the Kentucky Forest Conservation Act. In general, the peer reviewers and commenters stated that BMPs were effective at preventing sediment runoff from logging sites, thereby protecting water quality and instream habitats. They also explained that BMP implementation rates in the upper Kentucky River basin were higher than those reported in the proposed listing determination. Based on these factors, the reviewers stated the Service should reconsider its claim that the Kentucky Forest Conservation Act is an ineffective regulatory mechanism. To support their request, the reviewers provided updated and revised inspection data and new information related to BMP elements designed to improve BMP effectiveness.

Our Response: We agree with the commenters that BMP implementation rates are relatively high in the upper Kentucky River basin (greater than 70 percent), and forestry BMPs are effective in protecting water quality and instream habitats. However, as we discuss in the Factor D. The Inadequacy of Existing Regulatory Mechanisms section of this final listing determination, BMP compliance at inspected sites in the upper Kentucky River basin was only 73 percent between May 2014 and October 2015. Remedial actions were implemented at most noncompliant sites (74 percent) within a few months, but 26 percent of these sites remained noncompliant. The primary reason for noncompliance was related to the inadequate control of sediment laden runoff from skid trails, roads, and landings. Therefore, we agree with the commenters that forestry BMPs are effective in protecting water quality and preventing sedimentation; however, these impacts continue to occur within the upper Kentucky River basin due to BMP noncompliance. We have incorporated new compliance information provided by the commenters under the Factor D—The Inadequacy of Existing Regulatory Mechanisms section of this final listing determination. We have also included additional text regarding recent changes to Kentucky's BMP standards, which will be more protective of stream habitats. We agree with the peer reviewer and other commenters that BMP compliance rates were higher than those reported in the proposed listing rule, and recent changes to Kentucky's BMP standards will be more protective of stream habitats. However, BMP noncompliance continues to occur at some sites (about 26 percent), remedial actions at these sites sometimes take several months to complete, and some of these sites (6.5 percent) are never remediated.

(17) Comment: One peer reviewer recommended that the Service modify the discussion regarding genetic variation and gene flow because a detailed study of these factors is lacking.

Our Response: We concur with the peer reviewer and have modified our text accordingly in the Factor E. Other Natural or Manmade Factors Affecting Its Continued Existence—Restricted Range and Population Size section of this final listing determination.

(18) Comment: One commenter stated that the Service failed to consider how the Kentucky arrow darter's habitat is affected by the surrounding human population. This same commenter also suggested that mountaintop mining and fracking were not considered as potential threats to the species in the proposed rule, but should have been.

Our Response: We discussed a variety of human-induced habitat threats under the Factor A. The Present or Threatened Destruction, Modification, or Curtailment of its Habitat or Range section of this listing determination. In that section, we also provided a detailed summary of threats related to fracking and described specific impacts associated with a spill of chemicals used during the drilling process. Mountaintop coal mining is not mentioned within the proposed rule, but any potential impacts associated with mountaintop mining are addressed in our detailed discussion of impacts associated with surface coal mining in the Factor A. The Present or Threatened Destruction, Modification, or Curtailment of its Habitat or Range section of this listing determination. Surface coal mining is a broad category of coal mining that includes a variety of methods, such as area, auger, contour, and mountaintop mining.

(19) Comment: One commenter had concerns over perceived regulatory gaps associated with oil and gas development (and related infrastructure) on the Redbird Ranger District of the DBNF. Because some oil and gas resources within the Redbird Ranger District are privately owned, the commenter believed resource extraction activities in these areas would be exempt from National Environmental Policy Act (NEPA) requirements, and these projects would not be evaluated as closely for potential adverse effects to natural resources as activities occurring in areas under public ownership.

Our Response: The commenter is correct that mineral resources (i.e., coal, natural gas, oil) underlying much of the Redbird District of the DBNF are in private ownership, and that no Federal nexus exists with regard to actions associated with these minerals (including coal, oil/gas) in the DBNF. Because these mineral resources are in private ownership, oil and gas exploration activities taking place within them would not be subject to NEPA, and there would be no requirement for the DBNF to consult with the Service under section 7 of the ESA or apply standards of the DBNF's Land and Resource Management Plan (Forest Plan) to these privately held areas. The Service recognizes these regulatory gaps (with respect to privately held minerals) on the DBNF and has added language to the Factor D. The Inadequacy of Existing Regulatory Mechanisms section in this final listing determination.

(20) Comment: One commenter stated that the recently signed Candidate Conservation Agreement (CCA) between the Service and U.S. Forest Service fails to create new conservation measures that will be implemented on the DBNF to protect the Kentucky arrow darter.

Our Response: The CCA involves several new conservation measures that will benefit the species. Some of these measures include (1) the development and implementation of a long-term management and monitoring program for Kentucky arrow darter populations on the DBNF; (2) an inventory and mapping project of natural gas lines, oil wells, roads, other facilities, land ownership, and mineral ownership within Kentucky arrow darter watersheds on the DBNF; (3) the identification of restoration or enhancement opportunities for Kentucky arrow darter streams in coordination with Forest Plan standards, implementing those opportunities as funding and other resources allow; and (4) the initiation of an annual Kentucky arrow darter conservation meeting between the Service and DBNF to discuss the results of implementing the CCA. These and other conservation measures included in the CCA will benefit the species; however, these actions did not influence our final listing determination. The actions outlined in the CCA apply only to portions of Kentucky arrow streams located within the DBNF. The majority of Kentucky arrow populations (streams) and about 74 percent of the species' occupied habitat are located in areas outside of the DBNF that are not covered by the CCA. These populations will not benefit from specific conservation measures described in the CCA and will continue to be vulnerable to a variety of threats (see Factor A: The Present or Threatened Destruction, Modification, or Curtailment of Its Habitat or Range).

(21) Comment: One commenter disagreed with our description of roads on Robinson Forest, a 59.9-km 2 (14,800-acre (ac)) experimental forest owned and managed by the University of Kentucky (UK). The commenter stated that the roads on Robinson Forest are used for forest access and management and should not be described as logging roads. The same commenter also stated that, in addition to protection from mining provided through the Lands Unsuitable for Mining designation in the Kentucky Administrative Regulations (405 KAR 24:040), habitats within Robinson Forest are protected from potential habitat disturbance associated with private or recreational all-terrain vehicle (ATV) use.

Our Response: We agree with the commenter that roads on Robinson Forest should not be described as logging roads, and we have revised the corresponding text under the Population Estimates and Status section of this final rule. Under the Factor D. The Inadequacy of Existing Regulatory Mechanisms section of this final listing determination, we have added a description of UK's management guidelines for Robinson Forest. Under these guidelines, public access to Robinson Forest is controlled, and potential impacts from such activities as recreational ATV use are avoided.

We have considered all comments and information received during the open comment period for the proposed rule to list the Kentucky arrow darter as threatened. In this final rule, we have added species description and life-history information to the background section, and we have revised and updated the threats discussion (Summary of Factors Affecting the Species section). We added new information on spawning behavior and the development and viability of eggs, based on observations made during captive-propagation efforts by CFI. We also clarified information related to darter movements, discussing the difference between dispersal (intertributary movement) and simple movements within the same stream (intratributary movement). We added a more detailed description of feeding behavior, relying on observations made for the closely related Cumberland arrow darter in Tennessee. With regard to threats, we:

A thorough account of Kentucky arrow darter life history is presented in the preamble to the proposed rule (October 8, 2015, 80 FR 60962), and that information is incorporated here by reference. The following is a summary of that information. We have incorporated new information into the final rule, as appropriate (see Summary of Changes from the Proposed Rule).

The Kentucky arrow darter, Etheostoma spilotum Gilbert, is a small and compressed fish, with a background color of straw yellow to pale greenish and a body covered by a variety of stripes and blotches. During the spawning season, breeding males exhibit vibrant coloration. Most of the body is blue-green in color, with scattered scarlet spots and scarlet to orange vertical bars laterally.

The Kentucky arrow darter belongs to the Class Actinopterygii (ray-finned fishes), Order Perciformes, and Family Percidae (perches) (Etnier and Starnes 1993, pp. 18-25; Page and Burr 2011, p. 569). A similar darter species, the Cumberland arrow darter, E. sagitta (Jordan and Swain), is restricted to the upper Cumberland River basin in Kentucky and Tennessee, and the Kentucky arrow darter is restricted to the upper Kentucky River basin in Kentucky.

Kentucky arrow darters typically inhabit pools or transitional areas between riffles and pools (glides and runs) in moderate- to high-gradient, first- to third-order streams with rocky substrates (Thomas 2008, p. 6). The species is most often observed near some type of cover in depths ranging from 10 to 45 centimeters (cm) (4 to 18 in) and in streams ranging from 1.5 to 20 meters (m) (4.9 to 65.6 feet (ft)) wide. During spawning (April to June), the species utilizes riffle habitats with moderate flow (Kuehne and Barbour 1983, p. 71). Kentucky arrow darters typically occupy streams with watersheds of 25.9 square kilometers (km2) (10 square miles (mi2)) or less, and many of these habitats, especially in first-order reaches, can be intermittent in nature (Thomas 2008, pp. 6-9). During drier periods (late summer or fall), some Kentucky arrow darter streams may cease flowing, but the species appears to survive these conditions by retreating into shaded, isolated pools or by dispersing into larger tributaries (Lotrich 1973, p. 394; Lowe 1979, p. 26; Etnier and Starnes 1993, p. 523; ATS 2011, p. 7; Service unpublished data).

Little information is available on the reproductive behavior of the Kentucky arrow darter; however, general details were provided by Kuehne and Barbour (1983, p. 71), and more specific information can be inferred from studies of the closely related Cumberland arrow darter conducted by Bailey (1948, pp. 82-84) and Lowe (1979, pp. 44-50). Male Kentucky arrow darters establish territories over riffles and defend a fanned out depression in the substrate. After spawning, it is assumed the male continues to defend the nest until the eggs have hatched. The spawning period extends from April to June, but peak activity occurs when water temperatures reach 13 degrees Celsius (°C) (55 degrees Fahrenheit (°F)), typically in mid-April. Females produce between 200 and 600 eggs per season, with tremendous variation resulting from size, age, condition of females, and stream temperature (Rakes 2014, pers. comm.).

Captive-propagation efforts by CFI (2010-present) have yielded observations related to spawning behavior and the development and viability of eggs and larvae (Petty et al. 2015, pp. 4-7). The spawning period is dependent on several factors, but laboratory observations suggest that water temperature is likely a significant determinant of when spawning begins and how long it continues (Petty et al. 2015, p. 7). The appearance of larvae in the laboratory appeared to be delayed by cool water temperatures (less than10 °C), suggesting that cooler temperatures may (1) affect egg viability and/or larval survivorship or (2) simply increase development times of eggs and/or larvae. Another potential factor related to spawning period is the age and size of breeding darters. In the laboratory, large, older individuals spawned earlier and terminated earlier, while smaller, younger individuals matured and spawned later. Petty et al. (2015, p. 7) cautioned that hatchery observations are necessarily biased by the selection and use of mostly larger individuals in attempts to maximize production, so these larger individuals may not reflect the natural variation in wild populations with greater demographic (and environmental) diversity.

Kentucky arrow darters can reach 50 mm (2 in) in length by the end of the first year (Lotrich 1973, pp. 384-385; Lowe 1979, pp. 44-48; Kuehne and Barbour 1983, p. 71). One-year-olds are generally sexually mature and participate in spawning with older age classes (Etnier and Starnes 1993, p. 523). Juvenile Kentucky arrow darters can be found throughout the channel but are often observed in shallow water along stream margins near root mats, rock ledges, or some other cover. As stream flow lessens and riffles begin to shrink, most Kentucky arrow darters move into pools and tend to remain there even when late autumn and winter rains restore stream flow (Kuehne and Barbour 1983, p. 71).

Limited information exists with regard to upstream or downstream movements of Kentucky arrow darters; however, a movement study at Eastern Kentucky University (EKU) and a reintroduction project in the DBNF suggest that Kentucky arrow darters can move considerable distances (Baxter 2015, entire; Thomas 2015a, pers. comm.), which we summarize below.

The EKU study used PIT-tags (electronic tags placed under the skin) and placed antenna systems (installed in the stream bottom) to monitor intra- and inter-tributary movement of Kentucky arrow darters in Gilberts Big Creek and Elisha Creek, two second-order tributaries of Red Bird River in Clay and Leslie Counties (Baxter 2015, pp. 9-11). PIT-tags were placed in a total of 126 individuals, and Kentucky arrow darter movements were tracked from May 2013 to May 2014 (Baxter 2015, pp. 15, 19-21, 35-36). Recorded movements ranged from 134 m (439 ft) (upstream movement) to 4,078 m (13,379 ft or 2.5 mi) (downstream movement by a female in Elisha Creek). Intermediate recorded movements included 328 m (1,076 ft) (downstream), 351 m (1,151 ft) (upstream), 900 m (2,952 ft) (upstream/downstream), 950 m (3,116 ft) (downstream), 1,282 m (4,028 ft) (downstream), and 1,708 m (5,603 ft) (downstream). Based on this research, we believe it is likely that most of these documented movements could best be described as intrapopulational and represent individual darters moving between stream pools of Elisha Creek. In the case of the female arrow darter that moved unidirectionally from the headwaters of Elisha Creek to its mouth (a distance of more than 4,000 m (2.5 mi)), this documented movement could represent an interpopulational event (dispersal), where an individual leaves one population and travels to another population (or stream). Further research is needed to differentiate these behaviors.

Since August 2012, the Kentucky Department of Fish and Wildlife Resources (KDFWR) and CFI have been releasing captive-bred Kentucky arrow darters into a 1.5-km (0.9 mi) reach of Long Fork, a DBNF stream and first-order tributary to Hector Branch in eastern Clay County, Kentucky, where the species formerly occurred but has been extirpated. Researchers have tagged and released a total of 1,447 Kentucky arrow darters (about 50-55 mm TL) and have conducted monitoring on 14 occasions since the initial release using visual searches and seining methods. Tagged darters have been observed throughout the Long Fork mainstem, and some individuals have moved considerable distances (up to 1.0 km (0.4 mi)) downstream into Hector Branch. Based on these results, it is clear that young Kentucky arrow darters can disperse both upstream and downstream from their place of origin and can move considerable distances.

Kentucky arrow darters feed primarily on mayflies (Order Ephemeroptera), with larger darters also feeding on small crayfishes. Other food items include larval blackflies, midges, caddisfly larvae, stonefly nymphs, beetle larvae, microcrustaceans, and dipteran larvae (Lotrich 1973, p. 381; Etnier and Starnes 1993, p. 523).

A thorough account of the Kentucky arrow darter's historical range is presented in the preamble to the proposed rule (October 8, 2015, 80 FR 60962), and that information is incorporated here by reference. The following is a summary of that information with new information added as appropriate (see Summary of Changes from the Proposed Rule).

The Kentucky arrow darter occurred historically in at least 74 streams in the upper Kentucky River basin of eastern Kentucky (Gilbert 1887, pp. 53-54; Woolman 1892, pp. 275-281; Kuehne and Bailey 1961, pp. 3-4; Kuehne 1962, pp. 608-609; Branson and Batch 1972, pp. 507-514; Lotrich 1973, p. 380; Branson and Batch 1974, pp. 81-83; Harker et al. 1979, pp. 523-761; Greenberg and Steigerwald 1981, p. 37; Branson and Batch 1983, pp. 2-13; Branson and Batch 1984, pp. 4-8; Kornman 1985, p. 28; Burr and Warren 1986, p. 316; Measel 1997, pp. 1-105; Kornman 1999, pp. 118-133; Stephens 1999, pp. 159-174; Ray and Ceas 2003, p. 8; Kentucky State Nature Preserves Commission (KSNPC) unpublished data). Its distribution spanned portions of 6 smaller sub-basins or watersheds (North Fork Kentucky River, Middle Fork Kentucky River, South Fork Kentucky River, Silver Creek, Sturgeon Creek, and Red River) in 10 Kentucky counties (Breathitt, Clay, Harlan, Jackson, Knott, Lee, Leslie, Owsley, Perry, and Wolfe) (Thomas 2008, p. 3) (figure 1).

Based on surveys completed since 2006, extant populations of the Kentucky arrow darter are known from 47 streams in the upper Kentucky River basin in eastern Kentucky. These populations are scattered across 6 sub-basins (North Fork Kentucky River, Middle Fork Kentucky River, South Fork Kentucky River, Silver Creek, Sturgeon Creek, and Red River) in 10 Kentucky counties: Breathitt, Clay, Harlan, Jackson, Knott, Lee, Leslie, Owsley, Perry, and Wolfe Counties (Thomas 2008, pp. 3-6; Service unpublished data). Populations in eight of these streams have been discovered since 2006, and one additional population (Long Fork, Clay County) was reestablished through a reintroduction project led by KDFWR. Current populations occur in the following Kentucky River sub-basins (and smaller watersheds):

• North Fork Kentucky River (Troublesome, Quicksand, Frozen, Holly, Lower Devil, Walker, and Hell Creek watersheds);

• Middle Fork Kentucky River (Big Laurel, Rockhouse, Hell For Certain Creek, and Squabble Creek watersheds);

• South Fork Kentucky River (Red Bird River, Hector Branch, and Goose, Bullskin, Buffalo, and Lower Buffalo Creek watersheds);

• Silver Creek;

• Sturgeon Creek (Travis, Wild Dog, and Granny Dismal Creek watersheds); and

• Red River (Rock Bridge Fork watershed).

The species' status in all streams of historical or recent occurrence is summarized in table 1, below, which is organized by sub-basin, beginning at the southeastern border (upstream end) of the basin (North Fork Kentucky River) and moving downstream. In this final rule, the term “population” is used in a geographical context and not in a genetic context, and is defined as all individuals of the species living in one stream at a given time. Using the term in this way allows the status, trends, and threats to be discussed comparatively across streams where the species occurs. In using this term, we do not imply that the populations are currently reproducing and recruiting or that they are distinct genetic units. We considered populations of the Kentucky arrow darter as extant if live specimens have been observed or collected since 2006, and habitat conditions are favorable for reproduction (e.g., low siltation, water chemistry at normal levels).

We are using the following generalized sets of criteria to categorize the relative status of populations of 83 streams (74 historical and 9 nonhistorical, discovered or established since 2006) included in table 1. Similar criteria have been used by the Service in previous proposed listing rules (76 FR 3392, January 19, 2011; 77 FR 63440, October 16, 2012):

The status of a population is considered “stable” if: (1) There is little evidence of significant habitat loss or degradation; (2) darter abundance has remained relatively constant or increased during recent surveys; or (3) evidence of relatively recent recruitment has been documented since 2006.

The status of a population is considered “vulnerable” if: (1) There is ample evidence of significant habitat loss or degradation since the species' original capture; (2) there is an obvious decreasing trend in abundance since the historical collection; or (3) no evidence of relatively recent recruitment (since 2006) has been documented.

The status of a population is considered “extirpated” if: (1) All known suitable habitat has been destroyed or severely degraded; (2) no live individuals have been observed since 2006; or (3) live individuals have been observed since 2006, but habitat conditions do not appear to be suitable for reproduction to occur (e.g., elevated conductivity, siltation) and there is supporting evidence that the observed individuals are transients (fishes originating from another stream that occupy a particular habitat for only a short time).

In the period 2007-2012, the Service, KSNPC, and KDFWR conducted a status review for the Kentucky arrow darter (Thomas 2008, pp. 1-33; Service 2012, pp. 1-4). Surveys were conducted qualitatively using single-pass electrofishing techniques (Smith-Root backpack electrofishing unit) within an approximate 100-m (328-ft) reach. During these efforts, fish surveys were conducted at 69 of 74 historical streams, 103 of 119 historical sites, and 40 new (nonhistorical) sites (sites correspond to individual sampling reaches and more than one may be present on a given stream). Kentucky arrow darters were observed at 36 of 69 historical streams (52 percent), 53 of 103 historical sites (52 percent), and 4 of 40 new sites (10 percent). New sites were visited in an effort to locate additional populations and were specifically selected based on habitat suitability and the availability of previous collection records (sites lacking previous collections were chosen).

From June to September 2013, KSNPC and the Service initiated a study that included quantitative surveys at 80 randomly chosen sites within the species' historical range (Service unpublished data). Kentucky arrow darters were observed at only seven sites, including two new localities (Granny Dismal Creek in Owsley County and Spring Fork Quicksand Creek in Breathitt County) and one historical stream (Hunting Creek, Breathitt County) where the species was not observed during status surveys by Thomas (2008, pp. 1-33) and Service (2012, pp. 1-4).

During 2014-2015, additional qualitative surveys (single-pass electrofishing) were completed at more than 20 sites within the basin. Kentucky arrow darters were observed in Bear Branch, Big Double Creek, Big Laurel Creek, Bullskin Creek, Clemons Fork, Coles Fork, Cortland Fork, Laurel Fork Buffalo Creek, and Squabble Creek. Based on the poor habitat conditions observed in Bear Branch (e.g., elevated conductivity, siltation, and embedded substrates) and its close proximity to Robinson Forest, we suspect that the few individuals observed in Bear Branch were transients originating from Clemons Fork.

Based on historical records and survey data collected at more than 200 sites since 2006, the Kentucky arrow darter has declined significantly rangewide and has been eliminated from large portions of its former range, including 36 of 74 historical streams (figure 2) and large portions of the basin that would have been occupied historically by the species (figure 3). Forty-four percent of the species' extirpations (16 streams) have occurred since the mid-1990s, and the species has disappeared completely from several watersheds (e.g., Sexton Creek, South Fork Quicksand Creek, Troublesome Creek headwaters). Of the species' 47 extant streams, we consider half of these populations (23) to be “vulnerable” (table 1), and most remaining populations are isolated and restricted to short stream reaches.

A synopsis of the Kentucky arrow darter's current range and status is provided in the preamble to the proposed rule, and that information is incorporated here by reference.

Our recent survey data (Thomas 2008, pp. 25-27; Service 2012, pp. 1-4) indicate that Kentucky arrow darters occur in low densities. Sampling reaches where arrow darters were observed had an average of only 3 individuals per 100-m (328-ft) reach and a median of 2 individuals per reach (range of 1 to 10 individuals). ATS (2011, pp. 4-6) observed similar densities at occupied sampling reaches in the Buckhorn Creek watershed. Surveys in 2011 by the DBNF from Laurel Fork and Cortland Branch of Left Fork Buffalo Creek (South Fork Kentucky River sub-basin) produced slightly higher capture rates (an average of 5 darters per 100-m (328-ft) sampling reach) (Mulhall 2014, pers. comm.). The low abundance values (compared to other darters) are not surprising since Kentucky arrow darters generally occur in low densities, even in those streams where disturbance has been minimal (Thomas 2015b, pers. comm.).

Detailed information on population size is generally lacking for the species, but estimates have been completed for three streams: Clemons Fork (Breathitt County), Elisha Creek (Clay and Leslie Counties), and Gilberts Big Creek (Clay and Leslie Counties) (Service unpublished data). Based on field surveys completed in 2013 by EKU, KSNPC, and the Service, population estimates included 986-2,113 individuals (Clemons Fork), 592-1,429 individuals (Elisha Creek), and 175-358 individuals (Gilberts Big Creek) (ranges reflect 95 percent confidence intervals) (Baxter 2015, pp. 14-15, 18-19).

Based on observed catch rates and habitat conditions throughout the upper Kentucky River basin, the most stable and largest populations of the Kentucky arrow darter appear to be located in the following streams:

• Hell For Certain Creek, Leslie County;

• Laurel and Middle Forks of Quicksand Creek, Knott County;

• Frozen and Walker Creeks, Breathitt and Lee Counties;

• Clemons Fork and Coles Fork, Breathitt and Knott Counties;

• Several direct tributaries (e.g., Bowen Creek, Elisha Creek, and Big Double Creek) of the Red Bird River, Clay and Leslie Counties; and

• Wild Dog Creek, Jackson and Owsley Counties.

The Kentucky arrow darter is considered “threatened” by the State of Kentucky and has been ranked by KSNPC as a G2G3/S2S3 species (imperiled or vulnerable globally and imperiled or vulnerable within the State) (KSNPC 2014, p. 40). Kentucky's Comprehensive Wildlife Conservation Strategy (KDFWR 2013, pp. 9-11) identified the Kentucky arrow darter as a Species of Greatest Conservation Need (rare or declining species that requires conservation actions to improve its status).

Section 4 of the Act (16 U.S.C. 1533), and its implementing regulations at 50 CFR part 424, set forth the procedures for adding species to the Federal Lists of Endangered and Threatened Wildlife and Plants. Under section 4(a)(1) of the Act, we may list a species based on (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. Listing may be warranted based on any of the above threat factors, singly or in combination.

A thorough discussion of Kentucky arrow darter habitat destruction or modification is presented in the preamble to the proposed rule (October 8, 2015, 80 FR 60962), and that information is incorporated here by reference. The following is a summary of that information.

The Kentucky arrow darter's habitat and range have been destroyed, modified, and curtailed due to a variety of anthropogenic activities in the upper Kentucky River drainage. Resource extraction (e.g., coal mining, logging, oil/gas well development), land development, agricultural activities, and inadequate sewage treatment have all contributed to the degradation of streams within the range of the species (Branson and Batch 1972, pp. 513-516; Branson and Batch 1974, pp. 82-83; Thomas 2008, pp. 6-7; KDOW 2010, pp. 70-84; KDOW 2013a, pp. 189-214, 337-376; KDOW 2013b, pp. 88-94). These land use activities have led to chemical and physical changes to stream habitats that have adversely affected the species. Specific stressors have included inputs of dissolved solids and elevation of instream conductivity, sedimentation/siltation of stream substrates (excess sediments deposited in a stream), turbidity, inputs of nutrients and organic enrichment, and elevation of stream temperatures (KDOW 2010, p. 84; KDOW 2013a, pp. 189-214, 337-376). KDOW (2013a, pp. 337-376) provided a summary of specific threats within the upper Kentucky River drainage, identifying impaired reaches in 21 streams within the Kentucky arrow darter's historical range (table 2). Six of these streams continue to support populations of the species, but only one of these populations (Frozen Creek) is considered to be stable (see table 1, above). Results of probabilistic surveys (i.e., surveys conducted at randomly selected sites with sites selected in a statistically valid way) by KDOW demonstrate the spatial degree of threats across the species' range. Out of 22 probabilistic sites (streams) visited within the upper Kentucky River basin in 2003, 18 were considered to be impaired (Payne 2016, pers. comm.), suggesting habitats across the species' range are impacted by the specific stressors identified above.

One threat to the Kentucky arrow darter is water quality degradation caused by a variety of nonpoint-source pollutants (contaminants from many diffuse and unquantifiable sources). Within the upper Kentucky River drainage, coal mining has been the most significant historical source of these pollutants, and this activity continues to occur throughout the drainage.

Activities associated with coal mining have the potential to contribute high concentrations of dissolved salts, metals, and other solids that (1) elevate stream conductivity (a measure of electrical conductance in the water column that increases as the concentration of dissolved solids increases), (2) increase sulfates (a common dissolved ion with empirical formula of SO4 −2), and (3) cause wide fluctuations in stream pH (a measure of the acidity or alkalinity of water) (Curtis 1973, pp. 153-155; Dyer and Curtis 1977, pp. 10-13; Dyer 1982, pp. 1-16; Hren et al. 1984, pp. 5-34; USEPA 2003, pp. 77-84; Hartman et al. 2005, p. 95; Pond et al. 2008, pp. 721-723; Palmer et al. 2010, pp. 148-149; USEPA 2011, pp. 27-44). The coal mining process also results in leaching of metals and other dissolved solids that can result in elevated conductivity, sulfates, and hardness in the receiving stream. Stream conductivity in mined watersheds can be significantly higher compared to unmined watersheds, and conductivity values can remain high for decades (Merricks et al. 2007, pp. 365-373; Johnson et al. 2010, pp. 1-2).

Elevated levels of metals and other dissolved solids (i.e., elevated conductivity) in Appalachian streams have been shown to negatively impact biological communities, including losses of mayfly and caddisfly taxa (Chambers and Messinger 2001, pp. 34-51; Pond 2004, p. 7; Hartman et al. 2005, p. 95; Pond et al. 2008, pp. 721-723; Pond 2010, pp. 189-198), reduced occupancy and conditional abundance of salamanders (Price et al. 2015, pp. 6-9), and decreases in fish diversity (Kuehne 1962, pp. 608-614; Branson and Batch 1972, pp. 507-512; Branson and Batch 1974, pp. 81-83; Stauffer and Ferreri 2002, pp. 11-21; Fulk et al. 2003, pp. 55-64; Mattingly et al. 2005, pp. 59-62; Thomas 2008, pp. 1-9; Service 2012, pp. 1-4; Black et al. 2013, pp. 34-45; Hitt 2014, pp. 5-7, 11-13; Hitt and Chambers 2014, pp. 919-924; Daniel et al. 2015, pp. 50-61; Hitt et al. 2016, pp. 46-52).

There is a pattern of increasing conductivity and loss of arrow darter populations that is evident in the fish and water quality data from the Buckhorn Creek basin (1962 to present) in Breathitt and Knott Counties.

Kentucky arrow darters tend to be less abundant in streams with elevated conductivity levels (Service 2012, pp. 1-4; Service 2013, p. 9), and are typically excluded from these streams as conductivity increases (Branson and Batch 1972, pp. 507-512; Branson and Batch 1974, pp. 81-83; Thomas 2008, pp. 3-6). Recent range-wide surveys of historical sites by Thomas (2008, pp. 3-6) and the Service (2012, pp. 1-4) demonstrated that Kentucky arrow darters are excluded from watersheds when conductivity levels exceed about 250 μS/cm. The species was observed at only two historical sites where conductivity values exceeded 250 μS/cm, and average conductivity values were much lower at sites where Kentucky arrow darters were observed (115 μS/cm) than at sites where the species was not observed (689 μS/cm). Hitt et al. (2016, entire) reported that conductivity was a strong predictor of Kentucky arrow darter abundance in the upper Kentucky River drainage, and sharp declines in abundance were observed at 258 μS/cm (95 percent confidence intervals of 155-590 μS/cm). Based on the research presented in the preamble to the proposed rule and incorporated by reference here, we believe it is clear that the overall conductivity level is important in determining the Kentucky arrow darter's presence and vulnerability, but the species' presence is more likely tied to what individual metals or dissolved solids (e.g., sulfate) are present. Determination of discrete conductivity thresholds or the mechanisms through which the Kentucky arrow darter is influenced will require additional study (KSNPC 2010, p. 3; Pond 2015, pers. comm.); however, conductivity thresholds have been evaluated for other aquatic species. Elevated specific conductance has been positively correlated with decreased macroinvertebrate abundance (Pond et al. 2008, pp. 725-726; Pond 2012, p. 111), and Johnson et al. (2015, pp. 170-171) showed that daily growth rates and development of a mayfly (Neocleon triagnulifer) declined with increasing ionic concentrations. Increased levels of specific conductance have been shown to influence the behavior (Karraker et al. 2008, pp. 728-732) and corticosterone levels (a hormone secreted by the adrenal cortex that regulates energy, immune reactions, and stress responses) of amphibians (Chambers 2011, pp. 220-222). Embryonic and larval survival of amphibians were reduced significantly at moderate (500 μS/cm) and high (3,000 μS/cm) specific conductance levels (Karraker et al. 2008, pp. 728-732).

Mine drainage can also cause chemical (and some physical) effects to streams as a result of the precipitation of entrained metals and sulfate, which become unstable in solution (USEPA 2003, pp. 24-65; Pond 2004, p. 7). Precipitants accumulate on substrates, encrusting and cementing stream sediments, making them unsuitable for colonization by invertebrates and rendering them unsuitable as foraging or spawning habitat for the Kentucky arrow darter.

Oil and gas exploration and drilling activities represent another significant source of harmful pollutants in the upper Kentucky River basin (KDOW 2013a, pp. 189-214). Once used, fluid wastes containing chemicals used in the drilling and fracking process (e.g., hydrochloric acid, surfactants, potassium chloride) are stored in open pits (retention basins) or trucked away to treatment plants or some other storage facility. If spills occur during transport or releases occur due to retention basin failure or overflow, there is a risk for surface and groundwater contamination. Any such release can cause significant adverse effects to water quality and aquatic organisms that inhabit these watersheds (Wiseman 2009, pp. 127-142; Kargbo et al. 2010, pp. 5,680-5,681; Osborn et al. 2011, pp. 8,172-8,176; Papoulias and Velasco 2013, pp. 92-111).

Other nonpoint-source pollutants common within the upper Kentucky River drainage with potential to affect the Kentucky arrow darter include domestic sewage (through septic tank leakage or straight pipe discharges) and agricultural pollutants such as animal waste, fertilizers, pesticides, and herbicides (KDOW 2013a, pp. 189-214). Nonpoint-source pollutants can cause increased levels of nitrogen and phosphorus, excessive algal growths, oxygen deficiencies, and other changes in water chemistry that can seriously impact aquatic species (KDOW 2010, pp. 70-84; KDOW 2013a, pp. 189-214; KDOW 2013b, pp. 88-94). Nonpoint-source pollution may be correlated with impervious surfaces and storm water runoff (Allan 2004, pp. 266-267) and include sediments, fertilizers, herbicides, pesticides, animal wastes, septic tank and gray water leakage, pharmaceuticals, and petroleum products.

Sedimentation (siltation) has been listed repeatedly by KDOW as the most common stressor of aquatic communities in the upper Kentucky River basin (KDOW 2010, pp. 70-84; KDOW 2013a, pp. 189-214; KDOW 2013b, pp. 88-94). Sedimentation comes from a variety of sources, but KDOW identified the primary sources of sediment as loss of riparian habitat, surface coal mining, legacy coal extraction, logging, and land development (KDOW 2010, pp. 70-84; KDOW 2013b, pp. 88-94). All of these activities can result in canopy removal, channel disturbance, and increased siltation, thereby degrading habitats used by Kentucky arrow darters for both feeding and reproduction.

Resource extraction activities (e.g., surface coal mining, legacy coal extraction, logging, oil and gas exploration and drilling) are major sources of sedimentation in streams (Paybins et al. 2000, p. 1; Wiley et al. 2001, pp. 1-16; KDOW 2013a, pp. 189-214). Similarly, logging activities can adversely affect Kentucky arrow darters and other fishes through removal of riparian vegetation, direct channel disturbance, and sedimentation of instream habitats (Allan and Castillo 2007, pp. 332-333). Stormwater runoff from unpaved roads, ATV trails, and driveways represents a significant but difficult to quantify source of sediment that impacts streams in the upper Kentucky River basin.

Sediment has been shown to damage and suffocate fish gills and eggs, larval fishes, bottom-dwelling algae, and other organisms; reduce aquatic insect diversity and abundance; and, ultimately, negatively impact fish growth, survival, and reproduction (Berkman and Rabeni 1987, pp. 285-294; Waters 1995, pp. 5-7; Wood and Armitage 1997, pp. 211-212; Meyer and Sutherland 2005, pp. 2-3).

The hemlock woolly adelgid (Adelges tsugae), an aphid-like insect native to Asia, represents a potential threat to the Kentucky arrow darter because it has the potential to severely damage stands of eastern hemlocks (Tsuga canadensis) that occur within the species' range. Loss of hemlocks along Kentucky arrow darter streams has the potential to result in increased solar exposure and subsequent elevated stream temperatures, bank erosion, and excessive inputs of woody debris that will clog streams and cause channel instability and erosion (Townsend and Rieske-Kinney 2009, pp. 1-3). We expect these impacts to occur in some Kentucky arrow darter watersheds; however, we do not believe these impacts will be widespread or severe because eastern hemlocks are not abundant in all portions of the Kentucky arrow darter's range, and even where hemlocks are more common, we expect them to be replaced by other tree species.

In summary, habitat loss and modification represent threats to the Kentucky arrow darter. Severe degradation from contaminants, sedimentation, and physical habitat disturbance have contributed to extirpations of Kentucky arrow darter populations, and these threats continue to impact water quality and habitat conditions across the species' range. Contaminants associated with surface coal mining (metals, other dissolved solids), domestic sewage (bacteria, nutrients), and agriculture (fertilizers, pesticides, herbicides, and animal waste) cause degradation of water quality and habitats through increased conductivity and sulfates, instream oxygen deficiencies, excess nutrification, and excessive algal growths. Sedimentation from surface coal mining, logging, agriculture, and land development negatively affect the Kentucky arrow darter by burying or covering instream habitats used by the species for foraging, reproduction, and sheltering. These impacts can cause reductions in growth rates, disease tolerance, and gill function; reductions in spawning habitat, reproductive success, and egg, larval, and juvenile development; modifications of migration patterns; decreased food availability through reductions in prey; and reduction of foraging efficiency. Furthermore, these threats faced by the Kentucky arrow darter are the result of ongoing land uses that are expected to continue indefinitely.

The Kentucky arrow darter is not believed to be utilized for commercial, recreational, scientific, or educational purposes. Individuals may be collected occasionally in minnow traps by recreational anglers and used as live bait, but we believe these activities are practiced infrequently and do not represent a threat to the species. Our review of the available information does not indicate that overutilization is a threat to the Kentucky arrow darter now or likely to become so in the future.

No specific information is available suggesting that disease is a threat to the Kentucky arrow darter; however, in marginal Kentucky arrow darter streams (those with impacts from industrial or residential development), the occurrence of sewage-bacteria (Sphaerotilus) may a pose a threat with respect to fish condition and health (Pond 2015, pers. comm.). These bacteria are prevalent in many eastern Kentucky streams where straight-pipe sewage discharges exist and can often affect other freshwater organisms. The presence of these bacteria could also indicate the presence of other pathogens. Gill and body parasites such as flukes (flatworms) and nematodes (roundworms) have been noted in other species of Etheostoma (Page and Mayden 1981, p. 8), but it is unknown if these parasites infest or harm the Kentucky arrow darter.

Although the Kentucky arrow darter is undoubtedly consumed by native predators (e.g., fishes, amphibians, and birds), this predation is naturally occurring and a normal aspect of the species' population dynamics. Nonnative rainbow trout (Oncorhynchus mykiss) represent a potential predation threat (Etnier and Starnes 1993, p. 346) in one Kentucky arrow darter stream, Big Double Creek (Clay County), because KDFWR stocks up to 1,000 trout annually in the stream, with releases occurring in March, April, May, and October. To assess the potential predation of rainbow trout on Kentucky arrow darters or other fishes, the Service and DBNF surveyed a 2.1-km (1.3-mile) reach of Big Double Creek on April 21, 2014, which was 17 days after KDFWR's April stocking event (250 trout). A total of seven rainbow trout were captured, and the gut contents of these individuals were examined. Food items were dominated by Ephemeroptera (mayflies), with lesser amounts of Plecoptera (stoneflies), Trichoptera (caddisflies), Diptera (flies), Decapoda (crayfish), and terrestrial Coleoptera (beetles). No fish remains were observed. Based on all these factors and the absence of rainbow trout from the majority (98 percent) of Kentucky arrow darter streams demonstrates that predation by nonnative rainbow trout does not pose a threat to the species.

In short, our review of available information indicates that neither disease nor predation is currently a threat to the species or likely to become a threat to the Kentucky arrow darter in the future.

The Kentucky arrow darter has been identified as a threatened species within Kentucky (KSNPC 2014, p. 40), but this State designation conveys no legal protection for the species or its habitat. Kentucky law prohibits the collection of the Kentucky arrow darter (or other fishes) for scientific purposes without a valid State-issued collecting permit (Kentucky Revised Statutes (KRS) sec. 150.183). Kentucky regulations (301 KAR 1:130, sec. 1(3)) also allow persons who hold a valid Kentucky fishing license (obtained from KDFWR) to collect up to 500 minnows per day (a minnow is defined as any nongame fish less than 6 inches in length, with the exception of federally listed species). These existing regulatory mechanisms provide some protections for the species.

Streams within UK's Robinson Forest (Coles Fork, Snag Ridge Fork, and Clemons Fork) are currently protected from the effects of surface coal mining due to a 1990 “lands unsuitable for mining” designation (405 KAR 24:040). Streams within Robinson Forest (e.g., Clemons Fork and Coles Fork) are also protected from general disturbance by management guidelines approved by the UK's Board of Trustees in 2004 (Stringer 2015, pers. comm.). These guidelines provide general land use allocations, sustainable allowances for active research and demonstration projects involving overstory manipulation, allocations of net revenues from research and demonstration activities, and management and oversight responsibilities (Stringer 2015, pers. comm.). Under these guidelines, public access to Robinson Forest is controlled and potential impacts from such activities as recreational ATV use are avoided.

A significant portion (about 47 percent) of the species' remaining populations are located on the DBNF and receive management and protection through DBNF's land and resource management plan (LRMP) (USFS 2004, pp. 7-16) and a recently signed CCA between the DBNF and the Service (see Comment and Response #20 in the Summary of Comments and Recommendations section). Both of these documents contain conservation measures and protective standards that are intended to conserve the Kentucky arrow darter on the DBNF. Populations within the DBNF have benefited from management goals, objectives, and protective standards included in the LRMP. Collectively, these streams contain some of the best remaining habitats for the species and support some of the species' most robust populations.

The Kentucky arrow darter and its habitats are afforded some protection from water quality and habitat degradation under the Federal Water Pollution Control Act of 1977, commonly referred to as the Clean Water Act (33 U.S.C. 1251 et seq.); the Federal Surface Mining Control and Reclamation Act (SMCRA) (30 U.S.C. 1201 et seq.) of 1977; Kentucky's Forest Conservation Act of 1998 (KRS secs. 149.330-355); Kentucky's Agriculture Water Quality Act of 1994 (KRS secs. 224.71-140); and additional Kentucky laws and regulations regarding natural resources and environmental protection (KRS secs. 146.200-360; KRS sec. 224; 401 KAR secs. 5:026, 5:031). While these laws have undoubtedly resulted in some improvements in water quality and stream habitat for aquatic life, including the Kentucky arrow darter, sedimentation and other nonpoint-source pollutants continue to pose a threat to the species.

The KDOW has not established total maximum daily load (TMDLs) pursuant to the Clean Water Act for identified pollutants within portions of the upper Kentucky River basin historically occupied by the Kentucky arrow darter. TMDLs do not address chemical pollutants or sedimentation of aquatic habitats. The Service is also not aware of any other current or future changes to State or Federal water quality or mining laws that will substantially address the currently observed degradation of water quality.

Despite the current laws to prevent sediment and other pollutants from entering waterways, nonpoint-source pollution, originating from mine sites, unpaved roads, ATV trails, driveways, logging skid trails, and other disturbed habitats is considered to be a continuing threat to Kentucky arrow darter habitats.

Kentucky State laws and regulations regarding oil and gas drilling are generally designed to protect fresh-water resources like the Kentucky arrow darter's habitat, but these regulatory mechanisms do not contain specific provisions requiring an analysis of project impacts to fish and wildlife resources (Kentucky Division of Oil and Gas et al. 2012, entire). Current regulations also do not contain or provide any formal mechanism requiring coordination with, or input from, the Service or the KDOW regarding the presence of federally endangered, threatened, or candidate species, or other rare and sensitive species.

In July of 2015, the Office of Surface Mining Reclamation and Enforcement published in the Federal Register a notice of availability for a draft environmental impact statement regarding a proposed Stream Protection Rule (80 FR 42535, July 17, 2015) and the proposed Stream Protection Rule itself (80 FR 44436, July 27, 2015). The preamble for that proposed rule stated that the rule would better protect streams, fish, wildlife, and related environmental values from the adverse impacts of surface coal mining operations and provide mine operators with a regulatory framework to avoid water pollution and the long-term costs associated with water treatment (80 FR 44436, July 27, 2015; see SUMMARY). While the OSM proposed rule may provide benefits for the Kentucky arrow darter in the future, until the rule is finalized and implemented, we are unable to evaluate its potential effectiveness with regard to the Kentucky arrow darter and its habitat.

In summary, degradation of habitat for the Kentucky arrow darter is ongoing despite existing regulatory mechanisms.

The disjunct nature of some Kentucky arrow darter populations (figures 2 and 3, above) likely restricts the natural exchange of genetic material between populations and could make natural repopulation following localized extirpations of the species unlikely without human intervention. Populations can be further isolated by anthropogenic barriers, such as dams, perched culverts, and fords, which can limit natural dispersal and restrict or eliminate connectivity among populations (Eisenhour and Floyd 2013, pp. 82-83). Such dispersal barriers can prevent reestablishment of Kentucky arrow populations in reaches where they suffer localized extinctions due to natural or human-caused events. The localized nature and small size of many populations also likely makes them vulnerable to extirpation from intentional or accidental toxic chemical spills, habitat modification, progressive degradation from runoff (nonpoint-source pollutants), natural catastrophic changes to their habitat (e.g., flood scour, drought), and other stochastic disturbances (Soulé 1980, pp. 157-158; Hunter 2002, pp. 97-101; Allendorf and Luikart 2007, pp. 117-146). Inbreeding and loss of neutral genetic variation associated with small population size can further reduce the fitness of the population (Reed and Frankham 2003, pp. 230-237), subsequently accelerating population decline (Fagan and Holmes 2006, pp. 51-60).

Species that are restricted in range and population size are more likely to suffer loss of genetic diversity due to genetic drift, potentially increasing their susceptibility to inbreeding depression, decreasing their ability to adapt to environmental changes, and reducing the fitness of individuals (Soulé 1980, pp. 157-158; Hunter 2002, pp. 97-101; Allendorf and Luikart 2007, pp. 117-146). It is likely that some of the Kentucky arrow darter populations are below the effective population size required to maintain long-term genetic and population viability (Soulé 1980, pp. 162-164; Hunter 2002, pp. 105-107). The long-term viability of a species is founded on the conservation of numerous local populations throughout its geographic range (Harris 1984, pp. 93-104). These separate populations are essential for the species to recover and adapt to environmental change (Noss and Cooperrider 1994, pp. 264-297; Harris 1984, pp. 93-104).

The Intergovernmental Panel on Climate Change (IPCC) concluded that warming of the climate system is unequivocal (IPCC 2014, p. 3). Species that are dependent on specialized habitat types, limited in distribution, or at the extreme periphery of their range may be most susceptible to the impacts of climate change (see 75 FR 48911, August 12, 2010); however, while continued change is certain, the magnitude and rate of change is unknown in many cases.

Climate change has the potential to increase the vulnerability of the Kentucky arrow darter to random catastrophic events (McLaughlin et al. 2002, pp. 6060-6074; Thomas et al. 2004, pp. 145-148) associated with an expected increase in both severity and variation in climate patterns with extreme floods, strong storms, and droughts becoming more common (Cook et al. 2004, pp. 1015-1018; Ford et al. 2011, p. 2065; IPCC 2014, pp. 58-83). Estimates of the effects of climate change using available climate models typically lack the geographic precision needed to predict the magnitude of effects at a scale small enough to discretely apply to the range of a given species. However, data on recent trends and predicted changes for Kentucky (Girvetz et al. 2009, pp. 1-19), and, more specifically, the upper Kentucky River drainage (Alder and Hostetler 2013, entire), provide some insight for evaluating the potential threat of climate change to the Kentucky arrow darter. These models provide estimates of average annual increases in maximum and minimum temperature, precipitation, snowfall, and other variables.

There is uncertainty about the specific effects of climate change (and their magnitude) on the Kentucky arrow darter; however, climate change is almost certain to affect aquatic habitats in the upper Kentucky River drainage of Kentucky through increased water temperatures and more frequent droughts (Alder and Hostetler 2013, entire), and species with limited ranges, fragmented distributions, and small population size are thought to be especially vulnerable to the effects of climate change (Byers and Norris 2011, p. 18). Thus, we consider climate change to be a threat to the Kentucky arrow darter.

In summary, we have determined that other natural and manmade factors, such as geographical isolation, small population size, and climate change, are threats to remaining populations of the Kentucky arrow darter across its range. The severity of these threats is high because of the species' reduced range and population size, which result in a reduced ability to adapt to environmental change. Further, our review of the best available scientific and commercial information indicates that these threats are likely to continue or increase in the future.

We have carefully assessed the best scientific and commercial information available regarding the past, present, and future threats to the Kentucky arrow darter. As described in detail above, the Kentucky arrow darter has been extirpated from about 49 percent of its historical range (36 of 74 historical streams), 16 of these extirpations have occurred since the mid-1990s, populations in nearly half of the species' occupied streams are ranked as vulnerable (see table 1, above), and remaining populations are fragmented and isolated. Despite existing regulatory mechanisms (Factor D) and conservation efforts, the species continues to be at risk throughout all of its range due to the immediacy, severity, and scope of threats from habitat degradation and range curtailment (Factor A and other natural or manmade factors affecting its continued existence (Factor E).

Anthropogenic activities such as surface coal mining, logging, oil/gas development, land development, agriculture, and inadequate sewage treatment have all contributed to the degradation of stream habitats within the species' range (Factor A). These land use activities have led to chemical and physical changes to stream habitats that continue to affect the species. Specific stressors include inputs of dissolved solids and elevation of instream conductivity, sedimentation/siltation of stream substrates, turbidity, and inputs of nutrients and organic enrichment. These high-magnitude stressors, especially the inputs of dissolved solids and sedimentation, have had profound negative effects on Kentucky arrow darter populations and have been the primary factor in the species' decline. Existing regulatory mechanisms (e.g., the Clean Water Act) have provided for some improvements in water quality and habitat conditions across the species' range; however, recent extirpations have occurred (16 streams since the 1990s), and 21 streams within the species' historical range have been added to Kentucky's 303(d) list of impaired streams. The Kentucky arrow darter's vulnerability to these threats is even greater due to its reduced range, fragmented populations, and small or declining population sizes (Factor E) (Primack 2012, pp. 146-150). The effects of certain threats, particularly habitat degradation and loss, increase in magnitude when population size is small (Primack 2012, pp. 150-152).

The Act defines an endangered species as any species that is “in danger of extinction throughout all or a significant portion of its range” and a threatened species as any species “that is likely to become endangered throughout all or a significant portion of its range within the foreseeable future.” We find that the Kentucky arrow darter meets the definition of a threatened species based on the immediacy, severity, and scope of the threats identified above. The species' overall range has been reduced substantially, most of the species' historical habitat has been degraded, and much of the remaining habitat exists primarily in fragmented patches. Despite existing regulatory mechanisms and conservation efforts, current Kentucky arrow darter habitats continue to be lost or degraded due to surface coal mining, logging, oil/gas development, land development, agriculture, and inadequate sewage treatment, and it appears this trend will continue in the future. Extant populations are known from 47 streams, but these populations continue to be threatened by small population size, isolation, fragmentation, climate change, and the habitat degradation summarized above. All of these factors make the species particularly susceptible to extinction in the future.

We find that endangered status is not appropriate for the Kentucky arrow darter because we do not consider the species' threats to be so severe that extinction is imminent. Although threats to the species are ongoing, often severe, and occurring across the range, populations continue to occupy 47 scattered streams, 23 of which appear to support stable populations (see table 1, above). Additionally, a significant number of extant Kentucky arrow darter populations (49 percent) occur primarily on public lands (i.e., DBNF and Robinson Forest) that are at least partially managed to protect habitats used by the species. For example, the CCA with the U.S. Forest Service (USFS) for DBNF should provide an elevated level of focused management and conservation for portions of 20 streams that support populations of the Kentucky arrow darter. Based on all these factors, the Kentucky arrow darter does not meet the definition of an endangered species. Therefore, on the basis of the best available scientific and commercial information, we are listing the Kentucky arrow darter as a threatened species in accordance with sections 3(19) and 4(a)(1) of the Act.

Under the Act and our implementing regulations, a species may warrant listing if it is an endangered or threatened species throughout all or a significant portion of its range. Because we have determined that the Kentucky arrow darter is a threatened species throughout all of its range, no portion of its range can be “significant” for purposes of the definitions of “endangered species” and “threatened species.” See the Final Policy on Interpretation of the Phrase “Significant Portion of Its Range” in the Endangered Species Act's Definitions of “Endangered Species” and “Threatened Species” (79 FR 37577, July 1, 2014).

Conservation measures provided to species listed as endangered or threatened under the Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing results in public awareness and conservation by Federal, State, Tribal, and local agencies; private organizations; and individuals. The Act encourages cooperation with the States and calls for recovery actions to be carried out for listed species. The protection required by Federal agencies and the prohibitions against certain activities are discussed, in part, below.

The primary purpose of the Act is the conservation of endangered and threatened species and the ecosystems upon which they depend. The ultimate goal of such conservation efforts is the recovery of these listed species, so that they no longer need the protective measures of the Act. Subsection 4(f) of the Act calls for the Service to develop and implement recovery plans for the conservation of endangered and threatened species. The recovery planning process involves the identification of actions that are necessary to halt or reverse the species' decline by addressing the threats to its survival and recovery. The goal of this process is to restore listed species to a point where they are secure, self-sustaining, and functioning components of their ecosystems.

Recovery planning includes the development of a recovery outline shortly after a species is listed and preparation of a draft and final recovery plan. The recovery outline guides the immediate implementation of urgent recovery actions and describes the process to be used to develop a recovery plan. The plan may be revised to address continuing or new threats to the species, as new substantive information becomes available. The recovery plan also identifies recovery criteria for review of when a species may be ready for reclassification from endangered to threatened or for delisting and methods for monitoring recovery progress. Recovery plans also establish a framework for agencies to coordinate their recovery efforts and provide estimates of the cost of implementing recovery tasks. Recovery teams (composed of species experts, Federal and State agencies, nongovernmental organizations, and stakeholders) are often established to develop recovery plans. When completed, the recovery outline, draft recovery plan, and the final recovery plan will be available on our Web site (http://www.fws.gov/endangered), or from our Kentucky Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).

Implementation of recovery actions generally requires the participation of a broad range of partners, including other Federal agencies, States, Tribes, nongovernmental organizations, businesses, and private landowners. Examples of recovery actions include habitat restoration (e.g., restoration of native vegetation), research, captive propagation and reintroduction, and outreach and education. The recovery of many listed species cannot be accomplished solely on Federal lands because their range may occur primarily or solely on non-Federal lands. To achieve recovery of these species requires cooperative conservation efforts on private, State, and Tribal lands.

Following publication of this final rule, funding for recovery actions will be available from a variety of sources, including Federal budgets, State programs, and cost-share grants for non-Federal landowners, the academic community, and nongovernmental organizations. In addition, pursuant to section 6 of the Act, the State of Kentucky would be eligible for Federal funds to implement management actions that promote the protection or recovery of the Kentucky arrow darter. Information on our grant programs that are available to aid species recovery can be found at: http://www.fws.gov/grants.

Please let us know if you are interested in participating in recovery efforts for the Kentucky arrow darter. Additionally, we invite you to submit any new information on this species whenever it becomes available and any information you may have for recovery planning purposes (see FOR FURTHER INFORMATION CONTACT).

Section 7(a) of the Act requires Federal agencies to evaluate their actions with respect to any species that is listed as an endangered or threatened species and with respect to its critical habitat, if any is designated. Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR part 402. Section 7(a)(2) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of the species or destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into consultation with the Service.

Federal agency actions within the species' habitat that may require consultation as described in the preceding paragraph include management and any other landscape-altering activities on Federal lands administered by the USFS; issuance of section 404 Clean Water Act permits by the U.S. Army Corps of Engineers; construction and maintenance of gas pipeline and power line rights-of-way by the Federal Energy Regulatory Commission; USEPA pesticide registration; construction and maintenance of roads or highways by the Federal Highway Administration; and projects funded through Federal loan programs, which may include, but are not limited to, roads and bridges, utilities, recreation sites, and other forms of development.

The Service, in cooperation with KDFWR, KSNPC, the U.S. Geological Survey (USGS), KDOW, DBNF, CFI, and The Appalachian Wildlife Foundation, Inc., completed a conservation strategy for the Kentucky arrow darter in 2014 (Service 2014, entire). The strategy was developed as a guidance document that would assist the Service and its partners in their conservation efforts for the species. The strategy is divided into four major sections: (1) Biology and status, (2) listing factors/current threats, (3) current conservation efforts, and (4) conservation objectives/actions. The strategy's first conservation objective addresses current informational needs on the species' biology, ecology, viability, and survey methods, while the remaining three conservation objectives address specific threats facing the species (Factors A and E, respectively).

Several conservation efforts have been completed or are ongoing for the Kentucky arrow darter, and some of these efforts have been described previously in this listing determination. Previously mentioned efforts include the development of a CCA with the USFS (see Public Comments, Comment 20), a propagation and reintroduction study by KDFWR and CFI (see Background—Habitat and Life History), field investigations to determine the predatory risk posed by nonnative trout (see Factor C: Disease or Predation), and a movement and ecological study by EKU, KDFWR, and the Service (Baxter 2015, entire). Other important conservation actions include studies on the species' distribution, status, and population size; movement and microhabitat characteristics; genetics; and response to changes in water quality (e.g., conductivity). Details of these efforts are provided below.

In 2013, KSNPC and the Service initiated a study to investigate the distribution, status, population size, and habitat use of the Kentucky arrow darter within the upper Kentucky River basin. One important aspect of the study was to account for imperfect detection when surveying for the species. Studies that do not account for imperfect detection can often lead to an underestimation of the true proportion of sites occupied by a species and can bias assessments and sampling efforts (MacKenzie et al. 2002, entire; MacKenzie et al. 2005, entire). From June to September 2013, KSNPC and the Service visited 80 randomly chosen sites (ranging from first- to third-order) across the upper Kentucky River basin in order to address these concerns and meet project objectives. As expected, Kentucky arrow darters were rare during the study and were observed at only 7 of the 80 sites, including two new localities (Granny Dismal Creek in Owsley County and Spring Fork Quicksand Creek in Breathitt County) and one historical stream (Hunting Creek, Breathitt County) where the species was not observed during status surveys by Thomas (2008, pp. 1-33) and the Service (2012, pp. 1-4). Presently, KSNPC and the Service are in the data analysis stage of this project.

In July 2013, EKU, the Service, and KSNPC initiated a population estimate and microhabitat characterization study on Clemons Fork, Breathitt County. The study was designed to estimate the Kentucky arrow darter's current population size and average density within Clemons Fork and to compare current densities with historical densities reported by Lotrich (1973). Additionally, population densities and habitat parameters will be compared to data from Gilberts Big Creek and Elisha Creek (both DBNF) to aid in delineation of essential habitat characteristics and development and implementation of conservation efforts. Field surveys were completed in August 2013. Data analyses are incomplete, but initial results include a mean density of 9.69 Kentucky arrow darters per sampling reach and a population estimate of 986 to 2,113 darters in Clemons Fork (95 percent confidence intervals). Preliminary findings of this study were presented at the 2013 Southeastern Fishes Council Meeting, Lake Guntersville, Alabama (November 14-15, 2013).

Austin Peay State University is currently working with KDFWR and the Service on the first comprehensive assessment of genetic variation and gene flow patterns across the range of the Kentucky arrow darter (Johansen et al. 2013, pp. 1-3). Approximately 25 individuals per population from up to 12 populations across the range of the species will be genotyped using microsatellite markers. Resulting data will be used to generate robust estimates of effective population sizes and overall population and species' variability. This information is essential to the development of effective conservation and recovery measures to ensure the long-term persistence of the species. Funding for this project is being provided through the Service's section 6 program.

Through Service-USGS Quick Response funding, the USGS Leetown Science Center evaluated the relationship between Kentucky arrow darter abundance and stream conductivity in the upper Kentucky River basin (Hitt 2014, entire). Nonlinear regression techniques were used to evaluate significant thresholds and associated confidence intervals for Kentucky arrow darter abundance related to conductivity levels. As a contrast to Kentucky arrow darter, Dr. Hitt also evaluated blackside dace occurrence in this regard. Data for the study were supplied by the Service's Kentucky and Tennessee field offices, KDFWR, and KSNPC. Nonlinear regressions indicated a distinct decline in Kentucky arrow darter abundance at 258 µS/cm (95 percent confidence intervals 155-590 µS/cm), above which abundances were negligible. Nonlinear threshold declines for blackside dace were observed at 343 µS/cm, and 95 percent confidence intervals bounded this relationship between 123-632 µS/cm. Boosted regression results indicated that stream conductivity was the strongest predictor in separate analyses of Kentucky arrow darter and blackside dace abundance. Hitt (2014, pp. 7-8) concluded that the similar responses of these ecologically distinct taxa suggest the general importance of this water quality attribute for stream fish ecology in central Appalachia.

Under section 4(d) of the Act, the Service has discretion to issue regulations that we find necessary and advisable to provide for the conservation of threatened wildlife. We may also prohibit by regulation, with respect to threatened wildlife, any act that is prohibited by section 9(a)(1) of the Act for endangered wildlife. Exercising this discretion, the Service has developed general prohibitions that are appropriate for most threatened species at 50 CFR 17.31 and exceptions to those prohibitions at 50 CFR 17.32. While most of the prohibitions of §§ 17.31 and 17.32 are appropriate for the Kentucky arrow darter, we find that some activities that would normally be prohibited under §§ 17.31 and 17.32 are necessary for the conservation of this species because the species could benefit from habitat improvements in first- to third-order streams that are physically degraded (e.g., unstable stream channels, eroding banks, no canopy cover). Therefore, the Service has determined that a species-specific section 4(d) rule is appropriate to promote the conservation of the Kentucky arrow darter. As discussed in the Summary of Factors Affecting the Species section of this rule, the primary threat to the species is the continuing loss and degradation of habitat. Physical habitat degradation is widespread within the species' range, and sediment has been identified as the most common stressor (KDOW 2013a, pp. 189-214; KDOW 2013b, pp. 88-94). Sedimentation may originate from areas outside of the stream channel as a result of land use activities associated with surface coal mining, legacy coal extraction, logging, land development, channel relocations, and riparian clearing. All of these activities can cause sedimentation, but they may also lead to canopy removal, clearing of riparian vegetation, and elevation of stream temperatures, thereby degrading habitats used by Kentucky arrow darters for feeding, sheltering, and reproduction. Sedimentation may also originate from areas within the stream channel as a result of channel instability and bank or stream bed erosion. Numerous streams within the species' current range have been identified as impaired (primarily due to siltation) and have been included on Kentucky's 303(d) list of impaired waters (see table 2, above). Activities such as stream reconfiguration/riparian restoration, bridge and culvert replacement or removal, bank stabilization, and stream crossing repair and maintenance that follow the provisions of the species-specific 4(d) rule below will improve or restore physical habitat quality for the Kentucky arrow darter and will provide an overall conservation benefit to the species.

The 4(d) rule will not remove or alter in any way the consultation requirement under section 7 of the Act. However, we expect the 4(d) rule to provide greater certainty to Federal agencies and any third parties (e.g., permit applicants) in the consultation process for activities conducted in accordance with the provisions of the 4(d) rule. The consultation process may be further streamlined through programmatic consultations between Federal agencies and the Service for these activities.

This 4(d) rule exempts from the general prohibitions in 50 CFR 17.32 take that is incidental to the following activities when conducted within habitats currently occupied by the Kentucky arrow darter. All of the activities listed below must be conducted in a manner that (1) maintains connectivity of suitable Kentucky arrow darter habitats, allowing for dispersal between streams; (2) minimizes instream disturbance by conducting activities during low-flow periods when possible; and (3) maximizes the amount of instream cover that is available for the species:

(1) Channel reconfiguration or restoration projects that create natural, physically stable, ecologically functioning streams (or stream and wetland systems) that are reconnected with their groundwater aquifers (Parola and Biebighauser 2011, pp. 8-13; Parola and Hansen 2011, pp. 2-7; Floyd et al. 2013, pp. 129-135). These projects can be accomplished using a variety of methods, but the desired outcome is a natural, sinuous channel with low shear stress (force of water moving against the channel); low bank heights and reconnection to the floodplain; a reconnection of surface and groundwater systems, resulting in perennial flows in the channel; riffles and pools composed of existing soil, rock, and wood instead of large imported materials; low compaction of soils within adjacent riparian areas; and inclusion of riparian wetlands. First- to third-order, headwater streams reconstructed in this way would offer suitable habitats for the Kentucky arrow darter and contain stable channel features, such as pools, glides, runs, and riffles, which could be used by the species for spawning, rearing, growth, feeding, migration, and other normal behaviors.

(2) Bank stabilization projects that utilize bioengineering methods outlined by the Kentucky Energy and Environment Cabinet and Kentucky Transportation Cabinet (Kentucky Environmental and Public Protection Cabinet and Kentucky Transportation Cabinet 2005, pp. 116-128) to replace pre-existing, bare, eroding stream banks with vegetated, stable stream banks, thereby reducing bank erosion and instream sedimentation and improving habitat conditions for the species. Following these methods, stream banks may be stabilized using live stakes (live, vegetative cuttings inserted or tamped into the ground in a manner that allows the stake to take root and grow), live fascines (live branch cuttings, usually willows, bound together into long, cigar-shaped bundles), or brush layering (cuttings or branches of easily rooted tree species layered between successive lifts of soil fill). These methods would not include the sole use of quarried rock (rip-rap) or the use of rock baskets or gabion structures.

(3) Bridge and culvert replacement/removal projects that remove migration barriers (e.g., collapsing, blocked, or perched culverts) or generally allow for improved upstream and downstream movements of Kentucky arrow darters while maintaining normal stream flows, preventing bed and bank erosion, and improving habitat conditions for the species.

(4) Repair and maintenance of USFS concrete plank stream crossings in the DBNF that allow for safe vehicle passage while maintaining instream habitats, reducing bank and stream bed erosion and instream sedimentation, and improving habitat conditions for the species. These concrete plank crossings have been an effective stream crossing structure in the DBNF and have been used for decades. Over time, the planks can be buried by sediment or undercut during storm events, or simply break down and decay. If these situations occur, the DBNF must make repairs or replace the affected plank.

We believe that these actions and activities, while they may have some minimal level of mortality, harm, or disturbance to the Kentucky arrow darter, are not expected to adversely affect the species' conservation and recovery efforts. In fact, we believe that they would have a net beneficial effect on the species. Across the species' range, instream habitats have been degraded physically by sedimentation and by direct channel disturbance. The activities identified in this rule will correct some of these problems, creating more favorable habitat conditions for the species.

Based on the rationale above, the provisions included in this 4(d) rule are necessary and advisable to provide for the conservation of the Kentucky arrow darter. Nothing in this 4(d) rule would change in any way the recovery planning provisions of section 4(f) of the Act, the consultation requirements under section 7 of the Act, or the ability of the Service to enter into partnerships for the management and protection of the Kentucky arrow darter.

We may issue permits to carry out otherwise prohibited activities involving threatened wildlife under certain circumstances. Regulations governing permits are codified at 50 CFR 17.32. With regard to threatened wildlife, a permit may be issued for scientific purposes, to enhance the propagation or survival of the species, economic hardship, zoological exhibition, educational purposes, and for incidental take in connection with otherwise lawful activities. There are also certain statutory exemptions from the prohibited activities, which are found in sections 9 and 10 of the Act.

It is our policy, as published in the Federal Register on July 1, 1994 (59 FR 34272), to identify to the maximum extent practicable at the time a species is listed, those activities that would or would not constitute a violation of section 9 of the Act (for this species, those section 9 prohibitions adopted through the 4(d) rule). The intent of this policy is to increase public awareness of the effect of a final listing on proposed and ongoing activities within the range of a listed species. Based on the best available information, the following actions are unlikely to result in a violation of section 9, if these activities are carried out in accordance with existing regulations and permit requirements, although this list is not comprehensive:

(1) Normal agricultural and silvicultural practices, including herbicide and pesticide use, which are carried out in accordance with any existing regulations, permit and label requirements, and best management practices; and

(2) Surface coal mining and reclamation activities conducted in accordance with the 1996 BO between the Service and OSM.

However, we believe the following activities may potentially result in a violation of section 9 of the Act, although this list is not comprehensive:

(1) Unauthorized collecting or handling of the species.

(2) Destruction or alteration of the habitat of the Kentucky arrow darter (e.g., unpermitted instream dredging, impoundment, water diversion or withdrawal, channelization, discharge of fill material) that impairs essential behaviors such as breeding, feeding, or sheltering, or results in killing or injuring a Kentucky arrow darter.

(3) Discharges or dumping of toxic chemicals, contaminants, or other pollutants into waters supporting the Kentucky arrow darter that kills or injures individuals, or otherwise impairs essential life-sustaining behaviors such as breeding, feeding, or sheltering.

Questions regarding whether specific activities would constitute a violation of section 9 of the Act should be directed to the Kentucky Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).

We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act, need not be prepared in connection with listing a species as an endangered or threatened species under the Endangered Species Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

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. 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. No tribal lands or other interests are affected by the rule.

A complete list of references cited in this rulemaking is available on the Internet at http://www.regulations.gov in Docket No. FWS-R4-ES-2015-0132 and upon request from the Kentucky Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).

The primary authors of this final rule are the staff members of the Kentucky 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:

Why we need to publish a rule. Under the Endangered Species Act, a species may warrant protection through listing if it is endangered or threatened throughout all or a significant portion of its range. Listing a species as an endangered or threatened species can only be completed by issuing a rule.

The basis for our action. Under the Endangered Species Act, we may determine that a species is an endangered or threatened species based on any of five factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. We have determined that the threats to the Miami tiger beetle consist of habitat loss, degradation, and fragmentation, and proposed future development of habitat (Factor A); collection, trade, and sale (Factor B); inadequate protection from existing regulatory mechanisms (Factor D); and a small isolated population with a restricted geographical range, limited genetic exchange, and restricted dispersal potential that is subject to demographic and environmental stochasticity, including climate change and sea level rise (Factor E).

Peer review and public comment. We sought comments from independent specialists to ensure that our designation is based on scientifically sound data, assumptions, and analyses. We invited these peer reviewers to comment on our listing proposal. We also considered all other comments and information received during the comment period.

Please refer to the proposed listing rule for the Miami tiger beetle (80 FR 79533), published on December 22, 2015, for a detailed description of previous Federal actions concerning this species. We will also be proposing a designation of critical habitat for the Miami tiger beetle under the Act in the near future.

The discussion below incorporates revisions to the discussion in the proposed listing rule for the Miami tiger beetle (80 FR 79533; December 22, 2015) on taxonomy, distribution, and population estimates and status based on internal and peer review and public comments. Please refer to the proposed listing rule for discussion of the species' description, habitat, and biology.

Determining the taxonomy of a plant or animal and the relationship that this plant or animal has with similar, closely related members of its taxon involves the review of comparative morphology and descriptive characteristics, geographic range and separation of members, reproductive capabilities between members, and the genetic distinctiveness between them. Together the available information is assessed to determine the validity of a species.

The Miami tiger beetle (Cicindelidia floridana Cartwright) is a described species in the Subfamily Cicindelinae of the Family Carabidae (ground beetles). Previously, tiger beetles were considered a separate family, but are now classified as a subfamily of the family Carabidae on the basis of recent genetic studies and other characters (Bousquet 2012, p. 30). The Miami tiger beetle is in the C. abdominalis group that also includes the eastern pinebarrens tiger beetle (C. abdominalis), scabrous tiger beetle (C. scabrosa), and Highlands tiger beetle (C. highlandensis). New treatments of tiger beetles (Bousquet 2012, p. 30; Pearson et al. 2015, p. 138) have also elevated most of the previous subgenera of tiger beetles to genera, resulting in a change of the genus of the tiger beetles in the C. abdominalis group from Cicindela to Cicindelidia. These genera were originally proposed by Rivalier (1954, entire) and are widely used by European scientists (Wiesner 1992, entire), but are considered subgenera by many American scientists. The return to Rivalier's system has also been supported by genetic evidence (Pearson et al. 2015, p. 16).

The four species in the Cicindelidia abdominalis group all share a small body size (7-11 mm (0.28-0.43 in) long) and orange underside, and they occur in inland sandy habitats. The four beetles maintain separate ranges along the U.S. east coast and exhibit a significant gradient in range size: The eastern pinebarrens tiger beetle occurs from New York south along the coastal plain to north Florida; the scabrous tiger beetle is present throughout much of peninsular Florida, south to Ft. Lauderdale; the Highlands tiger beetle is restricted to the Lake Wales Ridge of Highlands and Polk Counties, Florida; and the Miami tiger beetle is found only in Miami-Dade County, Florida.

The Miami tiger beetle was first documented from collections made in 1934, by Frank Young (see Distribution, below). There were no observations after this initial collection, and the species was thought to be extinct until it was rediscovered in 2007, at the Zoo Miami Pine Rockland Preserve in Miami-Dade County. The rediscovery of a Miami tiger beetle population provided additional specimens to the 1934 collection and prompted a full study of its taxonomic status, which elevated it to a full species, Cicindelidia floridana (Brzoska et al. 2011, entire).

The Miami tiger beetle is distinguished from the three other species of the abdominalis group based on: (1) Morphology (color, maculation (spots or markings), and elytral (modified front wing) microsculpture); (2) distribution; (3) habitat requirements; and (4) seasonality (Brzoska et al. 2011, entire; Bousquet 2012, p. 313; Pearson et al. 2015, p. 138). This array of distinctive characters is comparable to the characters used to separate the other three species of the C. abdominalis group.

Although color is often variable and problematic as a sole diagnostic trait in tiger beetles, it is useful when combined with other factors (Brzoska et al. 2011, p. 4). In comparison with the closely related scabrous tiger beetle, the Miami tiger beetle has a green or bronze-green elytra, rarely with a post median marginal spot, and without evidence of a middle band, while the scabrous tiger beetle has a black elytra, with a post median marginal spot, usually with a vestige of a middle band (Brzoska et al. 2011, p. 6) (see Brzoska et al. 2011 for detailed description, including key). There are also noticeable differences in the width of the apical lunule (crescent shape), with the Miami tiger beetle's being thin and the scabrous tiger beetle's medium to thick.

In addition, the Miami tiger beetle has a narrower, restricted range where its distribution does not overlap with the other three species in the C. abdominalis group (i.e., the Miami tiger beetle has only been documented in Miami-Dade County). The Miami tiger beetle also occupies a unique habitat type (i.e., pine rockland versus scrub or open sand and barren habitat). These habitats also provide different larval microhabitat, which has been recognized as an important factor that separates species (T. Schultz, 2016, pers. comm.).

Lastly, the Miami tiger beetle has a broader period of adult activity than the “late spring to mid-summer” cycle that is observed in the scabrous tiger beetle (Brzoska et al. 2011, p. 6) (see also Distribution, Habitat, and Biology sections, below). Adult Miami tiger beetles have been observed from early May through mid-October; this is an unusually long flight period that suggests either continual emergence or two emergence periods (Brzoska et al. 2011, p. 6). In summary, the Miami tiger beetle is recognized as a distinct full species, based upon its differences in morphology, distribution, habitat, and seasonality (Brzoska et al. 2011, entire; Bousquet 2012, p. 313; Pearson et al. 2015, p. 138).

Genetics information is also commonly used to identify taxonomic relatedness. Genetic analyses for the Miami tiger beetle to date are limited to one non-peer-reviewed study, and available techniques (e.g., genomics, which can better study the process of speciation) are evolving. A limited genetic study using mitochondrial DNA (mtDNA) suggested that the eastern pinebarrens tiger beetle, Highlands tiger beetle, scabrous tiger beetle, and Miami tiger beetle are closely related and recently evolved (Knisley 2011a, p. 14). As with other similar Cicindela groups, these three sister species were not clearly separable by mtDNA analysis alone (Knisley 2011a, p. 14). The power of DNA sequencing for species resolution is limited when species pairs have very recent origins, because in such cases new sister species will share alleles for some time after the initial split due to persistence of ancestral polymorphisms, incomplete lineage sorting, or ongoing gene flow (Sites and Marshall 2004, pp. 216-221; McDonough et al. 2008, pp. 1312-1313; Bartlett et al. 2013, pp. 874-875). Changing sea levels and coincidental changes in the size of the land mass of peninsular Florida during the Pleistocene Era (2.6 million years ago to 10,000 years ago) is thought to be the key factor in the very recent evolutionary divergence and speciation of the three Florida species from C. abdominalis (Knisley 2015a, p. 5; Knisley 2015b, p. 4).

Despite the apparent lack of genetic distinctiveness from the one non-peer-reviewed, limited genetic study, tiger beetle experts and peer-reviewed scientific literature agree that, based on the morphological uniqueness, geographic separation, habitat specialization, and extended flight season, the Miami tiger beetle warrants species designation (Brzoska et al. 2011, entire; Bousquet 2012, p. 313; Pearson et al. 2015, p. 138). The most current peer-reviewed scientific information confirms that Cicindelidia floridana is a full species, and this taxonomic change is used by the scientific community (Brzoska et al. 2011, entire; Bousquet 2012, p. 313; Pearson et al. 2015, p. 138; Integrated Taxonomic Information System (ITIS), 2016, p. 1).

The ITIS was created by a White House Subcommittee on Biodiversity and Ecosystem Dynamics to provide scientifically credible taxonomic information and standardized nomenclature on species. The ITIS is partnered with Federal agencies, including the Service, and is used by agencies as a source for validated taxonomic information. The ITIS recognizes the Miami tiger beetle as a valid species (ITIS, 2016, p. 1). Both the ITIS (2016, p. 1) and Bousquet (2012, p. 313) continue to use the former genus, Cicindela (see discussion above). The Florida Natural Areas Inventory (FNAI) (2016, p. 16) and NatureServe (2015, p. 1) also accepts the Miami tiger beetle's taxonomic status as a species; however, FNAI uses the new generic designation, Cicindelidia. In summary, although there is some debate about the appropriate generic designation (Cicindelidia versus Cicindela), based upon the best available scientific information, the Miami tiger beetle is a valid species.

The historical range of the Miami tiger beetle is not completely known, and available information is limited based on the single historical observation prior to the species' rediscovery in 2007. It was initially documented from collections made in 1934 by Frank Young within a very restricted range in the northern end of the Miami Rock Ridge, in a region known as the Northern Biscayne Pinelands. The Northern Biscayne Pinelands, which extend from the city of North Miami south to approximately SW. 216th Street, are characterized by extensive sandy pockets of quartz sand, a feature that is necessary for the Miami tiger beetle (Service 1999, p. 3-162). The type locality (the place where the specimen was found) was likely pine rockland habitat, though the species is now extirpated from the area (Knisley and Hill 1991, pp. 7, 13; Brzoska et al. 2011, p. 2; Knisley 2015a, p. 7). The exact location of the type locality in North Miami was determined by Rob Huber, a tiger beetle researcher who contacted Frank Young in 1972. Young recalled collecting the type specimens while searching for land snails at the northeast corner of Miami Avenue and Gratigny Road (119th Street), North Miami. Huber checked that location the same year and found that a school had been built there. A more thorough search for sandy soil habitats throughout that area found no potential habitat (Knisley and Hill 1991, pp. 7, 11-12). Although the contact with Young did not provide habitat information for the type locality, a 1943 map of habitats in the Miami area showed pine rockland with sandy soils reaching their northern limit in the area of the type locality (Knisley 2015a, p. 27), and Young's paper on land snails made reference to pine rockland habitat (Young 1951, p. 6). Recent maps, however, show that the pine rockland habitat has been mostly developed from this area, and remaining pine rockland habitat is mostly restricted to sites owned by Miami-Dade County in south Miami (Knisley 2015a, p. 7).

In summary, it is likely that the Miami tiger beetle historically occurred throughout pine rockland habitat on the Miami Rock Ridge. Given the lack of recorded collection of the species for nearly 70 years, it may have always had a localized distribution (Schultz, 2016, pers. comm.).

The Miami tiger beetle was thought to be extinct until 2007, when a population was discovered at the Richmond Heights area of south Miami, Florida, known as the Richmond Pine Rocklands (Brzoska et al. 2011, p. 2; Knisley 2011a, p. 26). The Richmond Pine Rocklands is a mixture of publicly and privately owned lands that retain the largest area of contiguous pine rockland habitat within the urbanized areas of Miami-Dade County and outside of the boundaries of Everglades National Park (ENP). Surveys and observations conducted at Long Pine Key in ENP have found no Miami tiger beetles, and habitat conditions are considered unsuitable for the species (Knisley 2015a, p. 42; J. Sadle, 2015, pers. comm.). At this time, the Miami tiger beetle is known to occur in only two separate locations within pine rockland habitat in Miami-Dade County. The Richmond population occurs on four contiguous parcels within the Richmond Pine Rocklands: (1) Zoo Miami Pine Rockland Preserve (Zoo Miami) (293 hectares (ha); 723 acres (ac)), (2) Larry and Penny Thompson Park (121 ha; 300 ac), (3) U.S. Coast Guard property (USCG) (96 ha; 237 ac), and (4) University of Miami's Center for Southeastern Tropical Advanced Remote Sensing property (CSTARS) (31 ha; 76 ac) (see Table 1 in Supporting Documents on http://www.regulations.gov). The second population, which was recently identified (September 2015) is within approximately 5.0 km (3.1 mi) of the Richmond population and separated by urban development (D. Cook, 2015a, pers. comm.). Based on historical records, current occurrences, and habitat needs of the species (see Habitat section, below), the current range of the species is considered to be any pine rockland habitat (natural or disturbed) within the Miami Rock Ridge (Knisley 2015a, p. 7; CBD et al. 2014, pp. 13-16, 31-32).

Miami tiger beetles within the four contiguous occupied parcels in the Richmond population are within close proximity to each other. There are apparent connecting patches of habitat and few or no barriers (contiguous and border each other on at least one side) between parcels. Given the contiguous habitat with few barriers to dispersal, frequent adult movement among individuals is likely, and the occupied Richmond parcels probably represent a single population (Knisley 2015a, p. 10). Information regarding Miami tiger beetles at the new location is very limited, but beetles here are within approximately 5.0 km (3.1 mi) of the Richmond population and separated by ample urban development, which likely represents a significant barrier to dispersal, and the Miami tiger beetles at the new location are currently considered a second population.

The Richmond population occurs within an approximate 2-square-kilometer (km2) (494-ac) block, but currently much of the habitat is overgrown with vegetation, leaving few remaining open patches for the beetle. Survey data documented a decline in the number of open habitat patches, and Knisley (2015a, pp. 9-10) estimated that less than 10 percent of the mostly pine rockland habitat within this area supports the species in its current condition.

The visual index count is the standard survey method that has been used to determine presence and abundance of the Miami tiger beetle. Using this method, surveyors either walk slowly or stand still in appropriate open habitats, while taking a count of any beetle observations. Although the index count has been the most commonly used method to estimate the population size of adult tiger beetles, various studies have demonstrated it significantly underestimates actual numbers present. As noted earlier, several studies comparing various methods for estimating adult tiger beetle abundance have found numbers present at a site are typically two to three times higher than that produced by the index count (Knisley and Schultz 1997, p. 15; Knisley 2009, entire; Knisley and Hill 2013, pp. 27, 29). Numbers are underestimated because tiger beetles are elusive, and some may fly off before being detected while others may be obscured by vegetation in some parts of the survey area. Even in defined linear habitats like narrow shorelines where there is no vegetation and high visibility, index counts produce estimates that are two to three times lower than the numbers present (Knisley and Schultz 1997, p. 152).

Information on the Richmond population size is limited because survey data are inconsistent, and some sites are difficult to access due to permitting, security, and liability concerns. Of the occupied sites, the most thoroughly surveyed site for adult and larval Miami tiger beetles is the Zoo Miami parcel (over 30 survey dates from 2008 to 2014) (Knisley 2015a, p. 10). Adult beetle surveys at the CSTARS and USCG parcels have been infrequent, and access was not permitted in 2012 through early summer of 2014. In October 2014, access to both the CSTARS and USCG parcels was permitted, and no beetles were observed during October 2014 surveys. As noted earlier, Miami tiger beetles were recently found at Larry and Penny Thompson Park (D. Cook, 2015b, pers. comm.); however, thorough surveys at this location have not been conducted. For details on index counts and larval survey results from the three surveyed parcels (Zoo Miami, USCG, and CSTARS), see Table 2 in Supporting Documents on http://www.regulations.gov.

Raw index counts found adults in four areas (Zoo A, Zoo B, Zoo C, and Zoo D) of the Zoo Miami parcel. Two of these patches (Zoo C and Zoo D) had fewer than 10 adults during several surveys at each location. Zoo A, the more northern site where adults were first discovered, had peak counts of 17 and 22 adults in 2008 and 2009, but declined to 0 and 2 adults in six surveys from 2011 to 2014, despite thorough searches on several dates throughout the peak of the adult flight season (Knisley 2015a, pp. 9-10). Zoo B, located south of Zoo A, had peak counts of 17 and 20 adults from 2008 to 2009, 36 to 42 adults from 2011 to 2012, and 13 and 18 adults in 2014 (Knisley 2015a, pp. 9-10). These surveys at Zoo A and Zoo B also recorded the number of suitable habitat patches (occupied and unoccupied). Surveys between 2008 and 2014 documented a decline in both occupied and unoccupied open habitat patches. Knisley (2015, pp. 9-10) documented a decrease at Zoo A from 7 occupied of 23 patches in 2008, to 1 occupied of 13 patches in 2014. At Zoo B, there was a decrease from 19 occupied of 26 patches in 2008, to 7 occupied of 13 patches in 2014 (Knisley 2015a, pp. 9-10). Knisley (2015a, p. 10) suggested this decline in occupied and unoccupied patches is likely the result of the vegetation that he observed encroaching into the open areas that are required by the beetle.

At the CSTARS site, the only survey during peak season was on August 20, 2010, when much of the potential habitat was checked. This survey produced a raw count of 38 adults in 11 scattered habitat patches, with 1 to 9 adults per patch, mostly in the western portion of the site (Knisley 2015a, p. 10). Three surveys at the USCG included only a portion of the potential habitat and produced raw adult counts of two, four, and two adults in three separate patches from 2009, 2010, and 2011, respectively (Knisley 2015a, p. 10). Additional surveys of the CSTARS and the USCG parcels on October 14 to 15, 2014, surveyed areas where adults were found in previous surveys and some new areas; however, no adults were observed. The most likely reasons for the absence of adults were because counts even during the peak of the flight season were low (thus detection would be lower off-peak), and mid-October is recognized as the end of the flight season (Knisley 2014a, p. 2). As was noted for the Zoo Miami sites, habitat patches at the CSTARS and USCG parcels that previously supported adults seemed smaller due to increased vegetation growth, and consequently these patches appeared less suitable for the beetle than in the earlier surveys (Knisley 2015a, p. 10).

Surveys of adult numbers over the years, especially the frequent surveys in 2009, did not indicate a bimodal adult activity pattern (two cohorts of adults emerge during their active season) (Knisley 2015a, p. 10). Knisley (2015a, p. 10) suggests that actual numbers of adult Miami tiger beetles could be two to three times higher than indicated by the raw index counts. Several studies comparing methods for estimating population size of several tiger beetle species, including the Highlands tiger beetle, found total numbers present were usually more than two times that indicated by the index counts (Knisley and Hill 2013, pp. 27-28). The underestimates from raw index counts are likely to be comparable or greater for the Miami tiger beetle, because of its small size and occurrence in small open patches where individuals can be obscured by vegetation around the edges, making detection especially difficult (Knisley 2015a, p. 10).

Surveys for larvae at the Zoo Miami parcel (Zoos A and B) were conducted for several years during January when lower temperatures would result in a higher level of larval activity and open burrows (Knisley and Hill 2013, p. 38) (see Table 2 in Supporting Documents on http://www.regulations.gov). The January 2010 survey produced a count of 63 larval burrows, including 5 first instars, 36 second instars, and 22 third instars (Knisley 2013, p. 4). All burrows were in the same bare sandy patches where adults were found. In March 2010, a followup survey indicated most second instar larvae had progressed to the third instar (Knisley 2015a, p. 11). Additional surveys to determine larval distribution and relative abundance during January or February in subsequent years detected fewer larvae in section Zoo B: 5 larvae in 2011, 3 larvae in 2012, 3 and 5 larvae in 2013, 3 larvae in 2014, and 15 larvae in 2015 (Knisley 2013, pp. 4-5; Knisley 2015c, p. 1). The reason for this decline in larval numbers (i.e., from 63 in 2010, to 15 or fewer in each survey year from 2011 to 2015) is unknown. Possible explanations are that fewer larvae were present because of reduced recruitment by adults from 2010 to 2014, increased difficulty in detecting larval burrows that were present due to vegetation growth and leaf litter, environmental factors (e.g., temperature, precipitation, predators), or a combination of these factors (Knisley 2015a, pp. 10-11).

Larvae, like adults, also require open patches free from vegetation encroachment to complete their development. The January 2015 survey of Zoo B observed vegetation encroachment, as indicated by several of the numbered tags marking larval burrows in open patches in 2010 covered by plant growth and leaf litter (Knisley 2015c, p. 1). No larvae were observed in the January 2015 survey of Zoo A (Knisley 2015c, p. 1). Knisley (2015c, p. 3) reported that the area had been recently burned (mid-November) and low vegetation was absent, resulting in mostly bare ground with extensive pine needle coverage below trees, which made the identification of previous open patches with adults difficult.

Surveys for the beetle's presence outside of its currently known occupied range found no Miami tiger beetles at a total of 42 sites (17 pine rockland sites and 25 scrub sites) throughout Miami-Dade, Broward, Palm Beach, and Martin Counties (Knisley 2015a, pp. 9, 41-45). The absence of the Miami tiger beetle from sites north of Miami-Dade was probably because it never ranged beyond pine rockland habitat of Miami-Dade County and into scrub habitats to the north (Knisley 2015a, p. 9). Sites without the Miami tiger beetle in Miami-Dade County mostly had vegetation that was too dense and were lacking the open patches of sandy soil that are needed by adults for oviposition and larval habitat (Knisley 2015a, pp. 9, 41-45).

The Miami tiger beetle is considered as one of two tiger beetles in the United States most in danger of extinction (Knisley et al. 2014, p. 93). The viability of the remaining population is unknown, as no population viability analysis is available (B. Knisley, 2015d, pers. comm.). The Florida Fish and Wildlife Conservation Commission (FWC) (2012, p. 89) regarded it as a species of greatest conservation need. The Miami tiger beetle is currently ranked S1 and G1 by the FNAI (2016, p.16), meaning it is critically imperiled globally because of extreme rarity (5 or fewer occurrences, or fewer than 1,000 individuals) or because of extreme vulnerability to extinction due to some natural or manmade factor.

In summary, the overall population size of the Miami tiger beetle is exceptionally small and viability is uncertain. Based upon the index count data to date, it appears that the two populations exist in extremely low numbers (Knisley 2015a, pp. 2, 10-11, 24).

In the proposed rule published on December 22, 2015 (80 FR 79533), we requested that all interested parties submit written comments on the proposal by February 22, 2016. 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 the Miami Herald. We held a public hearing on January 13, 2016.

In accordance with our peer review policy published on July 1, 1994 (59 FR 34270), we solicited expert opinion from seven knowledgeable individuals with scientific expertise that included familiarity with tiger beetles and their habitat, biological needs, and threats. We appreciate the responses received from five of the peer reviewers.

We reviewed all comments received from the peer reviewers for substantive issues and new information regarding the listing of the Miami tiger beetle. All peer reviewers supported the endangered listing, and four of the five specifically stated that the best available scientific information was used in the proposed listing. The peer reviewers concurred with our methods and conclusions and provided additional information, clarifications, and suggestions to improve the final rule. Peer reviewer comments are addressed in the following summary and incorporated into the final rule as appropriate.

(1) Comment: One peer reviewer recommended the immediate use of fire management in pine rockland habitat for the Miami tiger beetle.

Our Response: We also recognize, as discussed below (see Summary of Factors Affecting the Species), the need for better land management, including the use of prescribed fire, additional survey and life-history data, further investigation into laboratory rearing for possible reintroduction, more extensive genetic analysis, and designation of critical habitat.

(2) Comment: One peer reviewer stated that one of the most relevant ecological factors that separate tiger beetle species is soil type and microhabitat of the larvae, and the limestone substrate of the Miami tiger beetle as opposed to the sandy habitats of the scabrous tiger beetle (C. scabrosa) reflect subsequent adaptation to a local habitat following a geographic separation.

Our Response: We have modified the language under Taxonomy above to incorporate this statement regarding larval microhabitat.

(3) Comment: One peer reviewer stated that the lack of collection of the Miami tiger beetle for decades after its initial discovery may indicate that it has always been very localized in its distribution.

Our Response: We have modified the language under Distribution above to incorporate this statement regarding a localized distribution.

(4) Comment: One peer reviewer stated that development in and around Miami tiger beetle habitat will present a decline to habitat quality through runoff from structures.

Our Response: We have modified Factor A below to incorporate this information.

(5) Comment: One peer reviewer stated that the negative impact of pesticides may be increased with the spread of the Zika virus.

Our Response: We have incorporated this information under Factor E below.

The Miami tiger beetle occurs only in Florida, and we received one comment letter from the Florida Fish and Wildlife Conservation Commission (FWC). FWC stated its plans to continue working with stakeholders to assess known and potential Miami tiger beetle habitat, conduct surveys, and advise on issues relating to Miami tiger beetle conservation and habitat management.

During the comment period for the proposed listing rule, we received a total of 73 comments from local governments, nongovernmental organizations, and private citizens. Of these 73 comments, 65 indicated support of the proposed listing. We appreciate all comments and have incorporated them into the final rule or responded to them below, as appropriate.

(6) Comment: Several commenters questioned the taxonomy as a result of Choate's work, use of best scientific and commercial data, morphological characteristics, and seasonality of the Miami tiger beetle.

Our Response: In accordance with section 4 of the Act, we are required to make listing determinations on the basis of the best scientific and commercial data available. Further, our Policy on Information Standards under the Act (published in the Federal Register on July 1, 1994 (59 FR 34271)), the Information Quality Act (section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (Pub. L. 106-554; H.R. 5658)), and our associated Information Quality Guidelines (www.fws.gov/informationquality/), provide criteria and guidance, and establish procedures to ensure that our decisions are based on the best scientific data and commercial data available.

The Taxonomy section above discusses the taxonomic designation of the Miami tiger beetle. The most currently peer-reviewed scientific information confirms that the Miami tiger beetle is a full species, and this taxonomic designation is used by the scientific community (Brzoska et al. 2011, entire; Bousquet 2012, p. 313; Pearson et al. 2015, p. 138; ITIS, 2016, p. 1; FNAI 2016, p. 16; NatureServe 2015, p. 1). The works referenced by commenters (Choate 1984 and 2003) pre-date the rediscovery of the Miami tiger beetle in 2007 and do not include the most currently accepted taxonomic standing of the species. Prior to the rediscovery, the species had not been observed since its original collection in 1934. Choate did not examine specimens of the Miami tiger beetle when he synonymized it with the scabrous tiger beetle (NatureServe 2015, p. 1).

Brzoska et al. (2011, entire) established taxonomic criteria and did not intend for color and other morphological features to be used in isolation as intended in the taxonomic criteria set. Color and maculation are commonly used to identify tiger beetles, especially in combination with geographic range and habitat (Knisley and Schultz 1997, pp. 5-10; Pearson et al. 2015, pp. 19-20). Color, morphological features (post median marginal spot, middle band, and apical (apex, the top or highest part forming a point) lunule (crescent-shaped), distribution, seasonality, and habitat type of the Miami tiger beetle are only used in combination to differentiate it from the scabrous tiger beetle (Brzoska et al. 2011, entire), so minor overlap in individual features, such as post median marginal spot as noted by the commenters, is not necessarily a uniquely identifying feature until taken into consideration with the other identifying factors.

Regarding color, all specimens of the Miami tiger beetle observed by Brzoska et al. (2011, entire) were bright metallic green dorsally on the head, pronotum, and elytron, while the scabrous tiger beetle is metallic black dorsally, with only a few individuals having a greenish head and pronotum (prominent plate-like structure that covers all or part of the thorax). Likewise, no Miami tiger beetles had a thick lunule or a middle band. This suite of characteristics identified by Brzoska et al. (2011, entire), clearly differentiate the Miami tiger beetle from the scabrous tiger beetle. Since Brzoska et al. (2011, entire), there has been no debate in the scientific literature about the taxonomic characters used to identify the Miami tiger beetle as a species, and to our knowledge all literature since Brzoska et al. (2011, entire) recognize it as a valid species (Bousquet 2012, p. 313; Pearson et al. 2015, p. 138; ITIS 2016, p. 1; FNAI 2016, p. 16; NatureServe 2015, p. 1).

Finally, we agree that there is some overlap in the adult activity period between the Miami tiger beetle and its closely related sister species, the scabrous tiger beetle; however, the adult flight season for the Miami tiger beetle extends into October, while that of the scabrous tiger beetle, which is far more widespread and has been collected on a more routine basis, does not. The Miami tiger beetle has been observed during October surveys for three separate years (2008, 2009, and 2011). Seasonality is only one of several factors used to differentiate the Miami tiger beetle from the scabrous tiger beetle.

(7) Comment: Three commenters stated that the genetic study on the Miami tiger beetle should not be rejected.

Our Response: We agree that distinct differences in DNA can be helpful in delineating species. The single genetic study that is available on the Miami tiger beetle was used in the listing determination process and is discussed in Taxonomy above. This genetic study concluded that the Miami, Highlands, scabrous, and eastern pinebarrens tiger beetles are all closely related, recently evolved, and not clearly separable by the mtDNA analysis conducted. This finding is not uncommon among closely related Cicindela groups (Woodcock and Knisley 2009, entire; Knisley 2011a, p. 14). The lack of genetic distinctiveness in the study does show that the mtDNA markers used (cytochrome b and cytochrome oxidase subunit 1) were not in agreement with the morphological, seasonal, ecological, and geographic criteria that have been used to identify the species (Choate 1984, entire; Brzoska et al. 2011, entire), but this finding is not necessarily an indication that they are not separate species.

Determining the taxonomy of a species and its evolutionary relationships with similar, closely related members of its taxon involves the review of comparative morphology and descriptive characteristics, geographic range and separation of members, reproductive capabilities between members, and the genetic distinctiveness between them. Together the available information is assessed to determine the validity of a species. This determination is not based on any one single factor in isolation, but rather on the weight of evidence from the suite of factors available. The identifying criteria that clearly define the sister species used in the genetic study (Choate 1984, entire; Brzoska et al. 2011, entire) have been peer reviewed and are accepted in the scientific literature (Bousquet 2012, p. 313; Pearson et al. 2015, p. 138; ITIS 2016, p. 1; FNAI 2016, p. 16; NatureServe 2015, p. 1). As suggested by one peer reviewer, an analysis using nuclear DNA, with multiple different genes, instead of the two that were used in the genetic analysis, may be more useful in the case of these closely related sister species.

(8) Comment: Five commenters provided information on observations of Miami tiger beetles at the following locations: University of Miami, Zoo Miami, Larry and Penny Thompson Park, Gold Coast Railroad Museum, U.S. Coast Guard, and an undisclosed location, miles away from the Richmond Pine Rocklands.

Our Response: The proposed rule listed the Miami tiger beetle as occurring on Zoo Miami, the University of Miami CSTARS Campus, Larry and Penny Thompson Park, the U.S. Coast Guard, and an undisclosed location within approximately 5 km (3 mi) of the Richmond Pine Rocklands. The Gold Coast Railroad Museum was not included in the proposed rule because it is the first reported observation of Miami tiger beetles. Since receiving this information, we have searched scientific and commercial data to validate this location. The Gold Coast Railroad Museum parcel is within close proximity to known occupied sites within the Richmond Pine Rocklands. Because of the contiguous habitat with few barriers to dispersal, many of the parcels within the Richmond Pine Rocklands are suitable or potentially suitable for the Miami tiger beetle.

(9) Comment: Two commenters expressed concern that the proposed rule lacked specificity in range or habitat boundaries for the Miami tiger beetle, which presents uncertainty for anyone planning development within the range of the species. So that the economic consequence of the rule can be appropriately evaluated, one commenter requested that the Service collect more survey data to better delineate habitat boundaries and make this data available for review and comment, prior to publication of a final rule.

Our Response: Under the Endangered Species Act, listing determinations must be made based on the best available scientific and commercial information. Economic and other potential impacts are not considered in the listing determination, but rather in the consideration of exclusion of areas from critical habitat under section 4(b)(2) of the Act, when in the process of designating critical habitat for a species. As discussed below (see Critical Habitat), we have found that critical habitat is not determinable at this time.

The Distribution section, above, discusses the historical and current range of the Miami tiger beetle. Additionally, we are continuing to study and define the specificity in range and habitat boundaries for the Miami tiger beetle.

(10) Comment: One commenter stated that the proposed rule did not appropriately capture the single-season survey data points collected by Miami-Dade County and Fairchild Tropical Botanic Garden, which provide some perspective on the population of the Miami tiger beetle in the Richmond Pine Rocklands.

Our Response: We received the survey data points collected by Miami-Dade County and others on January 29, 2016, after the proposed listing rule publication on December 22, 2015. Our description of the species' extant occurrences within the Richmond Pine Rocklands in the Distribution section above is consistent with the new data presented to us by Miami-Dade County (i.e., the Miami tiger beetle is known from four contiguous parcels within the Richmond Pine Rocklands: Zoo Miami Pine Rockland Preserve, Larry and Penny Thompson Park, University of Miami's Center for Southeastern Tropical Advanced Remote Sensing, and U.S. Coast Guard).

(11) Comment: One commenter stated that we incorrectly reported that no robber flies have been observed in areas where the Miami tiger beetles occur.

Our Response: We have revised Factor C below to include observations of potential predators, such as robber flies.

(12) Comment: One commenter recommended 12 pine rockland sites throughout Miami-Dade County be thoroughly surveyed for the Miami tiger beetle.

Our Response: We support further surveys for the species at sites throughout Miami-Dade County and appreciate the list provided of areas to target.

(13) Comment: Two commenters stated that the range of the Miami tiger beetle is unknown and improperly assumed to be limited. Both questioned why we did not reference Choate's (2003) field guide, which lists the scabrous tiger beetle as occurring in Miami-Dade County.

Our Response: Since Choate's published work considered the Miami tiger beetle a synonym for the scabrous tiger beetle, then it is logical that he listed the distribution as within Miami-Dade County. We used the more recent publication by Brzoska et al. (2011, entire) that elevated the Miami tiger beetle to species and is widely accepted in the scientific literature (Bousquet 2012, p. 313; Pearson et al. 2015, p. 138; ITIS 2016, p. 1; FNAI 2016, p. 16; NatureServe 2015, p. 1).

(14) Comment: Two commenters stated that the surveying efforts have been inadequate to conclude that the Miami tiger beetle is rare.

Our Response: Surveys (during the summers of 2008 and 2010) for the Miami tiger beetle have included 42 sites (17 pine rockland sites and 25 scrub sites) throughout Miami-Dade, Broward, Palm Beach, and Martin Counties (Knisley 2015a, pp. 9, 41-45). To date, the Miami tiger beetle is known to occur in only two small populations: The Richmond Pine Rocklands and an undisclosed pine rockland within 5 km (3.1 mi) of the Richmond population and separated by urban development. Limitations to surveys are noted above in Population Estimates and Status.

(15) Comment: Four of the comments received raised a question about the habitat of the type locality.

Our Response: The original description of the Miami tiger beetle (Cartwright 1939, p. 364) provided no detailed information regarding habitat type, other than being in Miami, Florida. Based on later correspondence between tiger beetle researchers and the collector of the type specimen, the general area of the collection was narrowed down to the vicinity of Gratigny Road and present-day Barry University (Brzoska et al. 2011, pp. 1-2). This general area was just north (approximately 2.2 km (1.4 mi)) of the northern extent of the pine rocklands on the Miami Rock Ridge in the 1940s (Davis 1943, entire), approximately 10 years after the collection from the type locality. In the 1980s and 1990s, collectors did look for the species in this general location, but this area was fully developed, with no remaining natural habitat. Based on the habitat types of the other closely related Cicindelidia that occur in Florida, it was assumed that the Miami tiger beetle, too, likely occupied scrub habitats. The species was then rediscovered in 2007 from pine rockland habitat. Based on historical photos and documents on Barry University (http://www.barry.edu/about/history/historic-photo-tour/ [accessed April 27, 2016]; Rice 1989, pp. 7, 10), there is evidence that the land currently occupied by Barry University had pine habitat with abundant pine trees and sandy soils. While this information is not irrefutable proof that it was pine rockland habitat, this area is consistent with the habitat type at the known currently occupied locations.

(16) Comment: One commenter stated that data do not support the conclusion that collection is a threat to the Miami tiger beetle.

Our Response: Based on data from other insects, including tiger beetles, we consider collection to be a significant threat to the Miami tiger beetle in light of the few known remaining populations, low abundance, and highly restricted range. Since publication of the proposed rule, we have received information on known unpermitted collection of Miami tiger beetles (Wirth, 2016a, pers. comm.). This new information is incorporated under Factor B below.

(17) Comment: One commenter expressed concern that disease and predation was not identified as a threat for the Miami tiger beetle.

Our Response: This topic is addressed under Factor C. below. We concluded that potential impact from predators or parasites to the Miami tiger beetle is unknown at this time, and, therefore it was not identified as a threat in the listing determination. However, Factor C below has been updated to include new observations on potential predators at a location known to have Miami tiger beetles.

(18) Comment: One commenter stated that existing regulatory mechanisms are adequate to protect the Miami tiger beetle, citing existing critical habitat for other listed species.

Our Response: These topics are discussed under Factor D below. The Miami tiger beetle is far rarer (i.e., fewer populations with fewer individuals within a limited distribution) than any of the other listed species with critical habitat that occur within pine rocklands in Miami-Dade County. As an unlisted species, the Miami tiger beetle is afforded limited protection from sections 7 and 10 of the Act based on its co-occurrence with listed species or their critical habitat; however, effects determinations and minimization and avoidance criteria for any of these listed species are unlikely to be fully protective. Critical habitat designations for other species also would not afford the beetle protections from take.

(19) Comment: One commenter stated that Miami-Dade County's regulatory and land protection programs protect Miami tiger beetle habitat. The commenter also specified that county's Environmentally Endangered Lands (EELs) program should be included under Factor A.

Our Response: This topic, including EELs, is addressed under Factor D below. Because Miami-Dade County's Natural Forested Communities (NFCs) designation allows for partial development of pine rockland habitat and there is known unpermitted development and destruction of pine rockland that continues to occur, the regulation is not fully protective against loss of Miami tiger beetles or their habitat. The county's EELs program funds the acquisition and maintenance of pine rockland habitat. Because these lands are not burned as frequently as needed to maintain suitable beetle habitat, they are not included in the discussion under Factor A, Conservation Efforts to Reduce the Present or Threatened Destruction, Modification, or Curtailment of Habitat or Range. We have incorporated this clarification into the final rule under Factor D below.

(20) Comment: One commenter stated that listing could be counter-productive to conducting valuable prescribed burns and habitat management by the Florida Forest Service.

Our Response: We agree that habitat management, including fire break and trail maintenance, prescribed fire, and mechanical and chemical treatment, is highly valuable for the Miami tiger beetle, but disagree that listing could be counter-productive to implementing prescribed burns or other habitat management activities by the Florida Forest Service. The Act requires us to make a determination using the best available scientific and commercial data after taking into account those efforts, if any, being made by any State, or any political subdivision of a State to protect such species, whether by predatory control, protection of habitat and food supply, or other conservation practices, within any area under its jurisdiction. Further, the listing of a species does not obstruct the development of conservation agreements or partnerships to conserve the species. Once a species is listed as either endangered or threatened, the Act provides many tools to advance the conservation of listed species. Conservation of listed species in many parts of the United States is dependent upon working partnerships with a wide variety of entities, including the voluntary cooperation of non-Federal landowners.

(21) Comment: One commenter stated that the best available science does not indicate that few, small, isolated populations are a threat for the Miami tiger beetle. They concluded that the Miami tiger beetle can persist in the long term with relatively small populations, and that we fail to explain why the Miami tiger beetle requires a different population target than other beetles.

Our Response: We acknowledge that populations of some tiger beetle species (e.g., northeastern beach, puritan, and Highlands tiger beetles) are able to persist with low population size, while other populations (e.g., Coral Pink Sand Dunes tiger beetles) have been extirpated. One peer reviewer stated that, given the small population sizes, the Miami tiger beetle could be extirpated by environmental fluctuations. Another peer reviewer stated that the vulnerability of the Miami tiger beetle is clearly established in the proposed rule due to the few remaining small populations and little remaining habitat. Given that the Miami tiger beetle is known only from two remaining isolated populations with few individuals, any significant decrease in the population size could easily result in extinction of the species. This issue is discussed under Factor E, below.

The proposed rule set no specific population target for the Miami tiger beetle. The species is considered rarer than any of the listed tiger beetle species (Knisley et al. 2014, p. 106). In an evaluation on the status of 62 tiger beetles in the United States, the Miami tiger beetle was considered as one of two tiger beetles most in danger of extinction (Knisley et al. 2014, p. 93). Florida Natural Areas Inventory (2016, p. 16) considered the species extremely vulnerable to extinction. One peer reviewer stated that the Miami tiger beetle is probably the most endangered species of tiger beetle in North America. Survey data to date indicate that the two populations exist in extremely low numbers. This topic is discussed under Population Estimates and Status above.

(22) Comment: One commenter stated that pesticide exposure in the Richmond Pine Rocklands is largely mitigated by current efforts to protect the Bartram's scrub-hairstreak butterfly. The commenter states that we fail to present the differing opinion on pesticides from Knisley (2014).

Our Response: We acknowledge that Miami-Dade Mosquito Control's (MDMCs) recent implementation of truck-based spray buffers around critical habitat for the Bartram's scrub-hairstreak butterfly have greatly reduced pesticide exposure to the Miami tiger beetle, and mosquito control is currently not considered a major threat for the known populations at this time. However, the current spray buffers are not regulations and are subject to change based on human health concerns, which is likely with the spread of the Zika virus as pointed out by one peer reviewer (see peer review comment (5) above). In addition, if the Miami tiger beetle was found to occur on habitat that is not protected by the butterfly's critical habitat, then exposure is possible. This topic is discussed under Factor E, below.

Regarding the Service not disclosing a differing opinion by Knisley (2014), it is unclear which Knisley (2014) opinion is referenced by the commenter. The supplemental documents provided by the commenter do not include a Knisley (2014) reference that addresses pesticides. Knisley's (2015a, pp. 15-16) species assessment on the Miami tiger beetle, which was modified from a Service species assessment, identified pesticides as a potential threat.

(23) Comment: One commenter stated that our analysis on the threat of climate change failed to present evidence on how the Miami tiger beetle is affected, since it has survived operations of a former naval air station, hurricanes, and operations by Zoo Miami. In addition, the commenter stated that, under most climate change predictions, Miami-Dade County's efforts should protect the pine rockland habitat from saltwater intrusion and must be included as the best available data.

Our Response: We agree that the Miami tiger beetle has survived operations of a former naval air station, hurricanes, and operations by Zoo Miami; however, we do not know the impact of these events on the Miami tiger beetle, because no surveys were conducted until after its rediscovery in 2007. All of the projected climate change scenarios indicate negative effects on pine rockland habitat throughout Miami-Dade County. This includes everything from rising temperatures, increased storm frequency and severity, changes in rainfall patterns, rising sea levels, and “coastal squeeze,” which occurs when the habitat is pressed between rising sea levels and coastal development. Even before projected inundation, pine rocklands are likely to undergo transitions including increased salinity in the water table and soils, which would cause vegetation shifts and potential impacts to the beetle. This issue is addressed in Factor E below. The commenter did not provide a reference to support its statement that Miami-Dade County's efforts should protect the pine rockland habitat from saltwater intrusion. Based on the best available scientific and commercial data available, we consider climate change a threat to the Miami tiger beetle.

(24) Comment: One commenter identified an editorial error under Factor A of the proposed rule (80 FR 79533, December 22, 2015; page 79540), which states that the two known populations of the Miami tiger beetle occur within the Richmond Pine Rocklands.

Our Response: We acknowledge that this was an editorial error, as the Miami tiger beetle is known from two populations, only one of which is found within the Richmond Pine Rocklands. We have revised this text under Factor A, below.

(25) Comment: One commenter stated that the proposed listing rule failed to present the positive examples of using prescribed fire in an urban landscape in citations from Snyder and URS. The commenter pointed out that the URS citation discussed the necessity of prescribed fire to avoid catastrophic risk to surrounding property, including homes, and even loss of life.

Our Response: We have incorporated these concepts under Factor A below.

(26) Comment: One commenter stated that the Service has been presented with the boundary limits of the proposed Miami Wilds development.

Our Response: We agree that the proposed boundary limits of the proposed Miami Wilds development have been presented to us. However, the statement in the proposed rule under Factor A, below, that plans have yet to be finalized, is accurate, since no formal review of the project has been initiated by the proposed applicant.

(27) Comment: One commenter expressed concern that routine operational maintenance in existing and potential future transmission and distribution right-of-ways (ROW), such as but not limited to vegetation management and power restoration, may be limited or hindered. The commenter requested that “utilities development” be excluded from the section 9 prohibited actions and that language be added indicating that permits will not be required for ROW maintenance activities.

Our Response: This type of request can be covered under a rule issued under section 4(d) of the Act, which allows for some “take” of a threatened species when the overall outcome of the allowed actions are “necessary and advisable to provide for the conservation of the species.” However, a special rule may not be promulgated for species listed as endangered, such as the Miami tiger beetle.

We strongly encourage that anyone conducting activities, including utilities development and maintenance on lands potentially supporting Miami tiger beetles to consult with the Service on their activities to ensure they do not jeopardize the continued survival and recovery of the beetle and that incidental take may be authorized. The Miami tiger beetle is one of several federally listed species that occurs in Miami-Dade County. Consultation could be done on a programmatic basis for power restoration and routine maintenance of ROWs for all listed species.

(28) Comment: Three comments received addressed the FWC's biological status review of the Miami tiger beetle. Two of the comments questioned how the FWC and Service would coordinate efforts. One of the commenters stated that the FWC should take the lead without duplication of efforts at the Federal level.

Our Response: It is our policy to coordinate with the FWC on all proposed and final listings, and we will continue to do so for all future actions. As stated in the Previous Federal Actions section of the proposed rule, the Service was petitioned to list the Miami tiger beetle. The Service's listing process and the Commission's biological status review are two separate and independent actions. However, we have incorporated language under Factor D below to reflect that the FWC was requested to undertake a biological status review on the Miami tiger beetle and is currently doing so.

(29) Comment: One commenter requested that any underlying data that were used in the proposed rule (e.g., field notes; photographs with notes on use of lighting, equipment, filters, or adjustments; any statistical analyses, collection, and laboratory data from genetic work; and peer review comments from Brzoska et al. (2011)) be included in a re-publication of the proposed rule.

Our Response: In rulemaking decisions under the Act, the Service makes available all cited literature used that is not already publicly available. We post grey literature, information from States, or other unpublished resources on http://www.regulations.gov concurrent with the Federal Register publication.

(30) Comment: One commenter stated that it was inappropriate to make references to the Coral Reef Commons proposed development and habitat conservation plan (HCP) in the proposed rule.

Our Response: Under Factor A below we discuss the threat of proposed development in the Richmond Pine Rocklands, but we do not directly use the name “Coral Reef Commons.” Information about this proposed development was cited using the publicly available draft HCP. This discussion is appropriate and required under section 4 of the Act (16 U.S.C. 1533), because the proposed development of Coral Reef Commons is within suitable Miami tiger beetle habitat and, therefore, must be included in an analysis of the threatened destruction of habitat.

(31) Comment: Two commenters questioned the peer review of documents used in the proposed listing rule, the reliance on the work of Dr. Barry Knisley, and the affiliation between Dr. Knisley and one of the petitioners.

Our Response: Dr. Knisley is regarded as one of the nation's foremost experts on tiger beetles generally (e.g., has (co)authored 58 publications including 3 books on tiger beetles) and the Miami tiger beetle specifically, and he has performed the vast majority of research on the Miami tiger beetle, including extensive surveys under contract with the Service. Thus, the heavy reliance on his work in the listing rule is fully appropriate. Christopher Wirth, one of the petitioners, was a former student and research assistant under Dr. Knisley; however, Dr. Knisley is not included as one of the petitioners. As noted by the commenters, Dr. Knisley has stated that his research focuses on the conservation of rare tiger beetles and unique natural areas. There is no basis or evidence to support the commenters' claims of bias on Dr. Knisley's part.

(32) Comment: Two commenters claim that photographs published in Brzoska et al. (2011, entire) appear to be digitally enhanced and, if so, must be fully disclosed. One of these commenters also presents pictures of the Miami and scabrous tiger beetles from the Florida State Collection of Arthropods (FSCA) and claims there are no discernible differences other than color.

Our Response: Photographs of specimens in Brzoska et al. (2011, entire) were taken by Christopher Wirth. He has informed us that the photographs were not digitally enhanced, and rely only on reflected flash lighting (Wirth, 2016b, pers. comm.). In regard to the photographs taken from the FSCA, it appears that the Miami and scabrous tiger beetles not only differ in coloration, but also the presence of a medial spot and thicker apical lunule (crescent shape) in the scabrous tiger beetle.

Based on information we received in peer review and public comments, we made the following changes:

In the Background section:

(1) We included larval microhabitat as an important factor to differentiate species.

(2) We revised the historical range of the Miami tiger beetle as possibly localized considering the lack of collection for nearly 70 years.

(3) We updated literature citations to those most currently available and replaced and removed citations from Duran and Gwiazdowski (in preparation) and Spomer (2014, pers. comm.), respectively.

In the Summary of Factors Affecting the Species section:

(4) We included run-off from potential development as a threat to habitat quality.

(5) We included discussion of the Zika virus under the potential for pesticide exposure.

(6) We included new observations of robber fly species in Miami tiger beetle habitat.

(7) We revised wording related to the location of the two known Miami tiger beetle populations.

(8) We added a citation and text pertaining to the necessity of fire to maintain pine rockland habitat.

(9) We included the State of Florida's biological status review of the Miami tiger beetle.

(10) We included new information on known collection of the Miami tiger beetle.

(11) We included text regarding maintenance of EELs lands within Miami-Dade County.

(12) We made minor editorial changes in verb tense, language clarification, and redundant word usage.

Section 4 of the Act and its implementing regulations at 50 CFR part 424 set forth the procedures for adding species to the Federal Lists of Endangered and Threatened Wildlife and Plants. Under section 4(a)(1) of the Act, we may list a species based on any of the following five factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; and (E) other natural or manmade factors affecting its continued existence. Listing actions may be warranted based on any of the above threat factors, singly or in combination. Each of these factors is discussed below:

The Miami tiger beetle is threatened by habitat loss and modification caused by changes in land use and inadequate land management, including the lack of prescribed burns and vegetation (native and nonnative) encroachment (discussed separately below). Habitat loss and modification are expected to continue and increase, affecting any populations on private lands as well as those on protected lands that depend on management actions (i.e., prescribed fire) where these actions could be precluded by surrounding development.

The Miami tiger beetle has experienced substantial destruction, modification, and curtailment of its habitat and range (Brzoska et al. 2011, pp. 5-6; Knisley 2013, pp. 7-8; Knisley 2015a, p. 11). The pine rockland community of south Florida, on which the beetle depends, is critically imperiled globally (FNAI 2013, p. 3). Destruction of the pinelands for economic development has reduced this habitat by 90 percent on mainland south Florida (O'Brien 1998, p. 208). Outside of ENP, only about 1 percent of the Miami Rock Ridge pinelands have escaped clearing, and much of what is left is in small remnant blocks isolated from other natural areas (Herndon 1998, p. 1).

One of the two known populations of the Miami tiger beetle occurs within the Richmond Pine Rocklands, on parcels of publicly or privately owned lands that are partially developed, yet retain some undeveloped pine rockland habitat. In the 1940s, the Naval Air Station Richmond was built largely on what is currently the Zoo Miami parcel. Much of the currently occupied Miami tiger beetle habitat on the Zoo Miami parcel was scraped for the creation of runways and blimp hangars (Wirth 2015, entire). The fact that this formerly scraped pine rockland area now provides suitable habitat for the Miami tiger beetle demonstrates the restoration potential of disturbed pine rockland habitat (Possley 2015, entire; Wirth 2015, entire).

Any current known or unknown, extant Miami tiger beetle populations or potentially suitable habitat that may occur on private lands or non-conservation public lands, such as elsewhere within the Richmond Pine Rocklands or surrounding pine rocklands, are vulnerable to habitat loss. Miami-Dade County leads the State in gross urban density at 8,343 people per square mile (https://www.bebr.ufl.edu/population/publications/measuring-population-density-counties-florida [accessed May 18, 2016]), and development and human population growth are expected to continue in the future. By 2025, Miami-Dade County is predicted to near or exceed a population size of 3 million people (Rayer and Wang 2016, p. 7). This predicted economic and population growth will further increase demands for land, water, and other resources, which will undoubtedly exacerbate the threats to the survival and recovery of the Miami tiger beetle.

Remaining habitat is at risk of additional losses and degradation. Of high and specific concern are proposed development projects within the Richmond Pine Rocklands (CBD et al. 2014, pp. 19-24). In 2013, plans for potential development on portions of the Zoo Miami and USCG parcels were announced in local newspapers (Munzenrieder 2013, entire) and subsequently advertised through other mechanisms (https://www.miamidade.gov/dpmww/SolicitationDetails.aspx?Id=Invitation%20To%20Negotiate%20(ITN) [accessed April 24, 2014]). The proposed development includes the following: Theme park rides; a seasonally opened water park; a 400-room hotel with a Sony Music Theatre performance venue; a 2,900-square meter (30,000-square feet) retail and restaurant village; an entertainment center with movie theaters and bowling; an outdoor area for sports; a landscaped pedestrian and bike path; parking; and a 2.4-km (1.5-mi) transportation link that unifies the project's parts (Dinkova 2014a, p. 1). The proposed development will require at least a portion of the USCG parcel, which would occur through purchase or a land swap (Dinkova 2014b, p. 1).

The Service notified Miami-Dade County in a December 2, 2014, letter about proposed development concerns with potential impacts to listed, candidate, and imperiled species, including the Miami tiger beetle. Plans for the proposed development on the Zoo Miami and USCG parcels have yet to be finalized, so potential impacts to the Miami tiger beetle and its habitat cannot be fully assessed. However, based upon available information provided to date, it appears that the proposed development will impact suitable or potentially suitable beetle habitat.

In July 2014, the Service became aware of another proposed development project on privately owned lands within the Richmond Pine Rocklands. In a July 15, 2014, letter to the proposed developer, the Service named the Miami tiger beetle (along with other federally listed and proposed species and habitats) as occurring within the project footprint, and expressed concern over indirect impacts (e.g., the ability to conduct prescribed fire within the Richmond Pine Rocklands). Based upon applicant plans received in May 2015, the proposed project will contain a variety of commercial, residential, and other development within approximately 56 ha (138 ac) (Ram 2015, p. 4). It is unknown if the Miami tiger beetle occurs on the proposed development site, as only one limited survey has been conducted on a small portion (approximately 1.7 ha (4.3 ac)) of the proposed development area and more surveys are needed. Based upon available information, it appears that the proposed developments will likely impact suitable or potentially suitable beetle habitat, because roughly 13 ha (33 ac) of the proposed development are planned for intact and degraded pine rocklands (Ram 2015, p. 91). The Service has met with the developers to learn more about their plans and how they will address listed, candidate, and imperiled species issues; negotiations are continuing, and a draft habitat conservation plan has been developed (Ram 2015, entire).

Given the species' highly restricted range and uncertain viability, any additional losses are significant. Additional development might further limit the ability to conduct prescribed burns or other beneficial management activities that are necessary to maintain the open areas within pine rockland habitat that are required by the beetle. The pattern of public and private ownership presents an urban wildland interface, which is a known constraint for implementing prescribed fire in similar pine rockland habitats (i.e., at National Key Deer Refuge and in southern Miami-Dade County) (Snyder et al. 2005, p. 2; Service 2009, p. 50; 79 FR 47180, August 12, 2014; 79 FR 52567, September 4, 2014). The Florida Department of Forestry has limited staff in Miami-Dade County, and they have been reluctant to set fires for liability reasons (URS 2007, p. 39) (see “Land Management,” below). In addition to constraints with fire management, run-off from development (e.g., structures, asphalt, concrete) into adjacent pine rockland habitat will likely increase and further alter the habitat quality (Schultz, 2016, pers. comm.).

In summary, given the Miami tiger beetle's highly restricted range and uncertain viability, any additional losses of habitat within its current range present substantial threats to its survival and recovery.

The threat of habitat destruction or modification is further exacerbated by a lack of adequate fire management (Brzoska et al. 2011, pp. 5-6; Knisley 2013, pp. 7-8; Knisley 2015a, p. 2). Historically, lightning-induced fires were a vital component in maintaining native vegetation within the pine rockland ecosystem, as well as for opening patches in the vegetation required by the beetles (Loope and Dunevitz 1981, p. 5; Slocum et al. 2003, p. 93; Snyder et al. 2005, p. 1; Knisley 2011a, pp. 31-32). Open patches in the landscape, which allow for ample sunlight for thermoregulation, are necessary for Miami tiger beetles to perform their normal activities, such as foraging, mating, and oviposition (Knisley 2011a, p. 32). Larvae also require these open patches to complete their development free from vegetation encroachment.

Without fire, successional change from tropical pineland to hardwood hammock is rapid, and displacement of native plants by invasive, nonnative plants often occurs, resulting in vegetation overgrowth and litter accumulation in the open, bare, sandy patches that are necessary for the Miami tiger beetle. In the absence of fire, pine rockland will succeed to tropical hardwood hammock in 20 to 30 years, as a thick duff layer accumulates and eventually results in the appearance of organic rich humic soils rather than organic poor mineral soils (Alexander 1967, p. 863; Wade et al. 1980, p. 92; Loope and Dunevitz 1981, p. 6; Snyder et al. 1990, p. 260). Fire is not only a necessity for maintaining pine rockland habitat, but also for preventing catastrophic loss to surrounding property and life in an urban landscape (URS 2007, p. 38). Studies and management plans have emphasized the necessity of prescribed fire in pine rockland habitat and highlighted it as preferential, compared to the alternatives to prescribed fire (e.g., herbicide application and mechanical treatment) (Snyder et al. 2005, p. 1; URS 2007, p. 39).

Miami-Dade County has implemented various conservation measures, such as burning in a mosaic pattern and on a small scale, during prescribed burns, to help conserve the Miami tiger beetles and other imperiled species and their habitats (URS, 2007, p. J. Maguire, 2010, pers. comm.). Miami-Dade County Parks and Recreation staff has burned several of its conservation lands on fire return intervals of approximately 3 to 7 years. However, implementation of the county's prescribed fire program has been hampered by a shortage of resources, logistical difficulties, smoke management, and public concern related to burning next to residential areas (Snyder et al. 2005, p. 2; FNAI 2010, p. 5). Many homes and other developments have been built in a mosaic of pine rockland, so the use of prescribed fire in many places has become complicated because of potential danger to structures and smoke generated from the burns. The risk of liability and limited staff in Miami-Dade County has hindered prescribed fire efforts (URS 2007, p. 39). Nonprofit organizations, such as the Institute for Regional Conservation, have faced similar challenges in conducting prescribed burns, due to difficulties with permitting and obtaining the necessary permissions, as well as hazard insurance limitations (Bradley and Gann 2008, p. 17; G. Gann, 2013, pers. comm.). Few private landowners have the means or desire to implement prescribed fire on their property, and doing so in a fragmented urban environment is logistically difficult and costly (Bradley and Gann 2008, p. 3). Lack of management has resulted in rapid habitat decline on most of the small pine rockland fragments, with the disappearance of federally listed and candidate species where they once occurred (Bradley and Gann 2008, p. 3).

Despite efforts to use prescribed fire as a management tool in pine rockland habitat, sites with the Miami tiger beetle are not burned as frequently as needed to maintain suitable beetle habitat. Most of the occupied beetle habitat at Miami-Dade County's Zoo Miami parcel was last burned in January and October of 2007; by 2010, there was noticeable vegetation encroachment into suitable habitat patches (Knisley 2011a, p. 36). The northern portion (Zoo A) of the Zoo Miami site was burned in November 2014 (Knisley 2015c, p. 3). Several occupied locations at the CSTARS parcel were burned in 2010, but four other locations at CSTARS were last burned in 2004 and 2006 (Knisley 2011a, p. 36). No recent burns are believed to have occurred at the USCG parcel (Knisley 2011a, p. 36). The decline in adult numbers at the two primary Zoo Miami patches (A and B) in 2014 surveys, and the few larvae found there in recent years, may be a result of the observed loss of bare open patches (Knisley 2015a, p. 12; Knisley 2015c, pp. 1-3). Surveys of the CSTARS and USCG parcels in 2014 found similar loss of open patches from encroaching vegetation (Knisley 2015a, p. 13).

Alternatives to prescribed fire, such as mechanical removal of woody vegetation, are not as ecologically effective as fire. Mechanical treatments do not replicate fire's ability to recycle nutrients to the soil, a process that is critical to many pine rockland species (URS 2007, p. 39). To prevent organic soils from developing, uprooted woody debris requires removal, which adds to the required labor. The use of mechanical equipment can also damage soils and inadvertently include the removal or trampling of other nontarget species or critical habitat (URS 2007, p. 39).

Nonnative plants have significantly affected pine rocklands (Bradley and Gann 1999, pp. 15, 72; Bradley and Gann 2005, numbers not applicable; Bradley and van der Heiden 2013, pp. 12-16). As a result of human activities, at least 277 taxa of nonnative plants have invaded pine rocklands throughout south Florida (Service 1999, p. 3-175). Neyraudia neyraudiana (Burma reed) and Schinus terebinthifolius (Brazilian pepper), which have the ability to rapidly invade open areas, threaten the habitat needs of the Miami tiger beetle (Bradley and Gann 1999, pp. 13, 72). S. terebinthifolius, a nonnative tree, is the most widespread and one of the most invasive species. It forms dense thickets of tangled, woody stems that completely shade out and displace native vegetation (Loflin 1991, p. 19; Langeland and Craddock Burks 1998, p. 54). Acacia auriculiformis (earleaf acacia), Melinis repens (natal grass), Lantana camara (shrub verbena), and Albizia lebbeck (tongue tree) are some of the other nonnative species in pine rocklands. More species of nonnative plants could become problems in the future, such as Lygodium microphyllum (Old World climbing fern), which is a serious threat throughout south Florida.

Nonnative, invasive plants compete with native plants for space, light, water, and nutrients, and make habitat conditions unsuitable for the Miami tiger beetle, which responds positively to open conditions. Invasive nonnatives also affect the characteristics of a fire when it does occur. Historically, pine rocklands had an open, low understory where natural fires remained patchy with low temperature intensity. Dense infestations of Neyraudia neyraudiana and Schinus terebinthifolius cause higher fire temperatures and longer burning periods. With the presence of invasive, nonnative species, it is uncertain how fire, even under a managed situation, will affect habitat conditions or Miami tiger beetles.

Management of nonnative, invasive plants in pine rocklands in Miami-Dade County is further complicated because the vast majority of pine rocklands are small, fragmented areas bordered by urban development. Fragmentation results in an increased proportion of “edge” habitat, which in turn has a variety of effects, including changes in microclimate and community structure at various distances from the edge (Margules and Pressey 2000, p. 248); altered spatial distribution of fire (greater fire frequency in areas nearer the edge) (Cochrane 2001, pp. 1518-1519); and increased pressure from nonnative, invasive plants and animals that may out-compete or disturb native plant populations. Additionally, areas near managed pine rockland that contain nonnative species can act as a seed source of nonnatives, allowing them to continue to invade the surrounding pine rockland (Bradley and Gann 1999, p. 13).

In 2005, the Service funded the Institute for Regional Conservation (IRC) to facilitate restoration and management of privately owned pine rockland habitats in Miami-Dade County. This initiative included prescribed burns, nonnative plant control, light debris removal, hardwood management, reintroduction of pines where needed, and development of management plans. The Pine Rockland Initiative includes 10-year cooperative agreements between participating landowners and the Service/IRC to ensure restored areas will be managed appropriately during that time. Although most of these objectives regarding nonnative plant control, creation of firebreaks, removal of excessive fuel loads, and management plans have been achieved, IRC has not been able to conduct the desired prescribed burns, due to logistical difficulties as discussed above (see “Land Management”). IRC has recently resolved some of the challenges regarding contractor availability for prescribed burns and the Service has extended IRC's funding period through August 2016. Results from anticipated fire management restoration activities will be available in the fall of 2016.

Fairchild Tropical Botanic Garden, with the support of various Federal, State, local, and nonprofit organizations, has established the “Connect to Protect Network.” The objective of this program is to encourage widespread participation of citizens to create corridors of healthy pine rocklands by planting stepping stone gardens and rights-of-way with native pine rockland species, and restoring isolated pine rockland fragments. Although these projects may serve as valuable components toward the conservation of pine rockland species and habitat, they are dependent on continual funding, as well as participation from private landowners, both of which may vary through time.

We have identified a number of threats to the habitat of the Miami tiger beetle that occurred in the past, continue currently, and are expected to impact the species in the future. Habitat loss, fragmentation, and degradation, and associated pressures from increased human population, are major threats; these threats are expected to continue, placing the species at greater risk. The species' occurrence on pine rocklands that are partially protected from development (see “Local” under Factor D, below) tempers some impacts, yet the threat of further loss and fragmentation of habitat remains. Various conservation programs are in place, and while these help to reduce some threats of habitat loss and modification, these programs are limited in nature. In general, available resources and land management activities (e.g., prescribed fire and invasive plant control) on public and private lands are inadequate to prevent modification and degradation of the species' habitat. Therefore, based on our analysis of the best available information, the present and future loss and modification of the species' habitat are major threats to the Miami tiger beetle throughout its range.

Rare beetles, butterflies, and moths are highly prized by collectors. Tiger beetles are the subject of more intense collecting and study than any other single beetle group (Pearson 1988, pp. 123-124; Knisley and Hill 1992a, p. 9; Choate 1996, p. 1; Knisley et al. 2014, p. 94). Interest in the genus Cicindela (and Cicindelidia) is reflected in a journal entitled “Cicindela,” which has been published quarterly since 1969 and is exclusively devoted to the genus. Tiger beetle collecting and the sale and trade of specimens have increased in popularity in recent years (Knisley et al. 2014, p. 138). Among the professional researchers and many amateurs that collect tiger beetles are individuals that take only small numbers; however, there are also avid collectors who take as many specimens as possible, often for sale or trade. At present, it is estimated that nationally 50 to 100 individuals collect tiger beetles, and approximately 50 individuals are avid collectors (Knisley 2015b, p. 14). Knowledge of and communication with many of these collectors suggest sale and trading of specimens has become much more common in recent years. The increased interest in collecting, along with photographing specimens, seems to have been stimulated in part due to the publication of the tiger beetle field guide (Pearson et al. 2006, entire). Collectors are especially interested in the less common forms, and may have little regard for their conservation (Knisley 2015b, p. 14). Recently, there was posting on social media from a tiger beetle collector with images of several rare species, including nine specimens of the Miami tiger beetle that are thought to have been collected at Zoo Miami (Wirth, 2016a, pers. comm.). There is ample evidence of collectors impacting imperiled and endangered butterflies (Gochfeld and Burger 1997, pp. 208-209) and even contributing to extirpations (Duffey 1968, p. 94). For example, the federally endangered Mitchell's satyr (Neonympha mitchellii mitchellii) is believed to have been extirpated from New Jersey due to overcollecting (57 FR 21567, May 20, 1992; Gochfeld and Burger 1997, p. 209).

Collection is a serious threat to the Miami tiger beetle due to the species' extreme rarity (a factor that increases demand by collectors) and vulnerability (i.e., uncertain status and viability with just two known populations and few individuals). Collection is especially problematic if adults are taken prior to oviposition or from small, isolated, or poor-quality sites. Because no large, high-quality sites are currently known, any collection can have serious ramifications on the survival of the remaining population(s).

The recent description of the species did not disclose the exact locations of occurrence, due to concerns with collection (Brzoska et al. 2011, p. 5); however, it is now believed that occurrences at Zoo Miami, USCG, and CSTARS in the Richmond population are fairly well known, especially in the tiger beetle collecting community (B. Knisley, 2014b, pers. comm.). We have no specific information on the collection pressure for the Miami tiger beetle, but it is expected to be high based upon what has transpired in comparable situations with other federally listed and imperiled tiger beetles and butterflies both nationwide and in Florida. For example, the federally endangered Ohlone tiger beetle (Cicindela ohlone) was collected from its type locality in California after its description in the scientific literature (66 FR 50340, October 3, 2001) (Knisley 2015a, p. 14). Similarly, overcollection of the Highlands tiger beetle may have contributed to the extirpation of that species from its type locality in Florida (Knisley and Hill 1992a, p. 9). An estimated 500 to 1,000 adult Highlands tiger beetles had been collected at this site during a several year period after its initial discovery (Knisley and Hill 1992a, p. 10).

Markets currently exist for tiger beetles. Specimens of two Florida tiger beetles, the Highlands tiger beetle, a Federal candidate species, and the scabrous tiger beetle are regularly offered for sale or trade through online insect dealers (The Bugmaniac 2015 and eBay 2015). Considering the recent rediscovery of the Miami tiger beetle and concerns regarding its continued existence, the desirability of this species to private collectors is expected to increase, which may lead to similar markets and increased demand.

Another reason it is not possible to assess actual impacts from collection is that known occurrences of the Miami tiger beetle are not regularly monitored. Two known occurrences on the USCG and CSTARS parcels are gated and accessible only by permit, so collection from these sites is unlikely unless authorized by the property owners. However, other occupied and potential habitats at neighboring and surrounding areas are much more accessible. Risk of collection is concerning at any location and is more likely at less secure sites. Collection potential at Zoo Miami and other accessible sites is high, in part because it is not entirely gated and only periodically patrolled (Knisley, 2014b, pers. comm.). Most of the remaining pine rockland habitat outside of ENP in Miami-Dade County is owned by the County or in private ownership and not regularly monitored or patrolled.

We consider collection to be a significant threat to the Miami tiger beetle in light of the few known remaining populations, low abundance, and highly restricted range. Even limited collection from the remaining populations could have deleterious effects on reproductive and genetic viability of the species and could contribute to its extinction. Removal of adults early in the flight season or prior to oviposition can be particularly damaging, as it further reduces potential for successful reproduction. A population may be reduced to below sustainable numbers (Allee effect) by removal of females, reducing the probability that new occurrences will be founded. Small and isolated occurrences in poor habitat may be at greatest risk (see Factor E discussion, below) as these might not be able to withstand additional losses. Collectors may be unable to recognize when they are depleting occurrences below the thresholds of survival or recovery (Collins and Morris 1985, pp. 162-165).

With regard to scientific research, we do not believe that general techniques used to date have had negative impacts on the species or its habitat. Visual index surveys and netting for identification purposes have been performed during scientific research and conservation efforts with the potential to disturb or injure individuals or damage habitat. Limited collection as part of laboratory rearing studies or taxonomic verification has occurred at some sites, with work authorized by permits. Based on the extreme rarity of the species, various collecting techniques (e.g., pitfall traps, Malaise traps, light traps) for other more general insect research projects should be considered a potential threat.

Collection interest in tiger beetles, especially rare species, is high, and markets currently exist. While it is not possible to quantify the impacts of collection on the Miami tiger beetle, collection of the Highlands tiger beetle has been documented in large numbers, and collection is currently occurring. The risk of collection of the Miami tiger beetle from both occupied and other potential habitat is high, as some sites are generally accessible and not monitored or patrolled. Due to the combination of few remaining populations, low abundance, and restricted range, we have determined that collection is a significant threat to the species and could potentially occur at any time. Even limited collection from the remaining populations could have negative effects on reproductive and genetic viability of the species and could contribute to its extinction.

There is no evidence of disease or pathogens affecting the Miami tiger beetle, although this threat has not been investigated. Parasites and predators, however, have been found to have significant impacts on adult and larval tiger beetles. In general, parasites are considered to have greater effects on tiger beetles than predators (Nagano 1982, p. 34; Pearson 1988, pp. 136-138). While parasites and predators play important roles in the natural dynamics of tiger beetle populations, the current small size of the Miami tiger beetle populations may render the species more vulnerable to parasitism and predation than historically, when the species was more widely distributed and, therefore, more resilient.

Known predators of adult tiger beetles include birds, lizards, spiders, and especially robber flies (family Asilidae) (Pearson et al. 2006, p. 183). Researchers and collectors have often observed robber flies in the field capturing tiger beetles out of the air. Pearson (1985, pp. 68-69; 1988, p. 134) found tiger beetles with orange abdomens (warning coloration) were preyed upon less frequently than similar-sized tiger beetles without the orange abdomens. His field trials also determined that size alone provided some protection from robber flies, which are usually only successful in killing prey that is smaller than they are. This was the case with the hairy-necked tiger beetle (Cicindela hirticollis) being attacked at a significantly higher rate than the larger northeastern beach tiger beetle in Maryland (Knisley and Hill 2010, pp. 54-55).

On the basis of these field studies, it was estimated that robber flies may cause over 50 percent mortality to the hairy-necked tiger beetle and 6 percent to the northeastern beach tiger beetle population throughout the flight season (Knisley and Hill 2010, pp. 54-55). The small body size of the Miami tiger beetle, even with its orange abdomen, suggests it would be susceptible to robber fly attack. A few species of robber flies (Polacantha gracilis, Triorla interrupta, Efferia sp., and Diogmites sp.) have been observed in pine rocklands where the Miami tiger beetle is present (Mays and Cook 2015, p. 5; J. Kardys, 2016, pers. comm.); however, they are a common predator of the closely related Highlands tiger beetle (Knisley and Hill 2013, p. 40). In 24 hours of field study, Knisley and Hill (2013, p. 40) observed 22 attacks by robber flies on Highlands tiger beetles, 5 of which resulted in the robber fly killing and consuming the adult beetles.

Most predators of adult tiger beetles are opportunistic, feeding on a variety of available prey and, therefore, probably have only a limited impact on tiger beetle populations. However, predators, and especially parasites, of larvae are more common, and some attack only tiger beetles. Ants are regarded as important predators on tiger beetles, and although not well studied, they have been reported having significant impact on first instar larvae of some Arizona tiger beetles (Cicindela spp.) (Knisley and Juliano 1988, p. 1990). A study with the Highlands tiger beetle found ants accounted for 11 to 17 percent of larval mortality at several sites, primarily involving first instars (Knisley and Hill 2013, p. 37). During surveys for the Miami tiger beetle, various species of ants were commonly seen co-occurring in the sandy patches with adults and larvae, but their impact, if any, is unknown at this time.

Available literature indicates that the most important tiger beetle natural enemies are tiphiid wasps and bombyliid flies, which parasitize larvae (Knisley and Schultz 1997, pp. 53-57). The wasps enter the larvae burrows, and paralyze and lay an egg on the larvae. The resulting parasite larva consumes the host tiger beetle larva. Bombyliid flies (genus Anthrax) drop eggs into larval burrows with the resulting fly larvae consuming the tiger beetle larva. These parasitoids accounted for 20 to 80 percent mortality in larvae of several northeastern tiger beetles (Pearson and Vogler 2001, p. 172). Parasitism from bombyliid flies accounted for 13 to 25 percent mortality to larvae of the Highlands tiger beetle at several sites (Knisley and Hill 2013, p. 37). Generally, these rates of parasitism are similar to those reported for other species of tiger beetles (Bram and Knisley 1982, p. 99; Palmer 1982, p. 64; Knisley 1987, p. 1198). No tiphiid wasps or bombyliid flies were observed during field studies with the Miami tiger beetle (Knisley 2015a, p. 15); however, tiphiid wasps are small, secretive, and evidence of their attacks is difficult to find (Knisley 2015b, p. 16).

Potential impacts from predators or parasites to the Miami tiger beetle are unknown. Given the small size of the Miami tiger beetle's two populations, the species is likely vulnerable to predation and parasitism.

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 such species. . . .” In relation to Factor D, we interpret this language to require the Service to consider relevant Federal, State, and Tribal laws, plans, regulations, and other such mechanisms that may minimize any of the threats we describe in threat analyses under the other four factors, or otherwise enhance conservation of the species. We give strongest weight to statutes and their implementing regulations and to management direction that stems from those laws and regulations. An example would be State governmental actions enforced under a State statute or constitution, or Federal action under statute.

The Miami tiger beetle currently has no Federal protective status and has limited regulatory protection in its known occupied and suitable habitat. The species is not known to occur on National Wildlife Refuge System or National Park Service land. The Miami tiger beetle is known to occur on USCG lands within the Richmond Pinelands Complex, and there are limited protections for the species on this property; any USCG actions or decisions that may have an effect on the environment would require consideration and review under the National Environmental Policy Act (NEPA) (42 U.S.C. 4321 et seq.). No Federal permit or other authorization is currently needed for potential impacts to known occurrences on county-owned and private land. The Miami tiger beetle could be afforded limited protections from sections 7 and 10 of the Act based on its co-occurrence with listed species or their critical habitat, if applicable, within the Richmond Pine Rocklands, including species such as the Bartram's scrub-hairstreak butterfly (Strymon acis bartrami), Florida leafwing butterfly (Anaea troglodyta floridalis), Florida bonneted bat (Eumops floridanus), Brickellia mosieri (Florida brickell-bush), Linum carteri var. carteri (Carter's small-flowered flax), Chamaesyce deltoidea ssp. deltoidea (deltoid spurge), and Polygala smallii (tiny polygala). However, effect determinations and minimization and avoidance criteria for any of these listed species are unlikely to be fully protective to the Miami tiger beetle considering its extreme rarity. The listed species have broader distributions that allow for more flexibility with appropriate conservation measures. In contrast, with only two known populations and few remaining adults, the Miami tiger beetle has a much lower threat tolerance. Although the beetle is not currently federally protected, the Service has met with Miami-Dade County, the USCG, the University of Miami, and potential developers to express our concern regarding listed, proposed, candidate, and imperiled species in the Richmond Pine Rocklands, including the Miami tiger beetle. We have recommended that management and habitat conservation plans include and fully consider this species and its habitat.

The Miami tiger beetle is not currently listed as endangered or threatened by the State of Florida, so there are no existing regulations designated to protect it. The Miami tiger beetle is recognized as a species of greatest conservation need by the FWC (FWC 2012, p. 89). Species of greatest conservation need designation is part of the State's strategy to recognize and seek funding opportunities for research and conservation of these species, particularly through the State Wildlife Grants program. The list is extensive and, to date, we are unaware of any dedicated funding from this program for the beetle. The State was also petitioned and has started a biological status review of the species. The Miami tiger beetle is not known to occur on lands owned by the State of Florida; however, not all State-owned pine rockland parcels have been adequately surveyed. It is possible that some State-owned parcels do provide potentially suitable habitat for, and support occurrences of, the Miami tiger beetle.

In 1984, section 24-49 of the Code of Miami-Dade County established regulation of County-designated Natural Forested Communities (NFCs), which include both pine rocklands and tropical hardwood hammocks. These regulations were placed on specific properties throughout the county by an act of the Board of County Commissioners in an effort to protect environmentally sensitive forest lands. The Miami-Dade County Department of Regulatory and Economic Resources (RER) has regulatory authority over NFCs, and is charged with enforcing regulations that provide partial protection on the Miami Rock Ridge. Miami-Dade Code typically allows up to 20 percent of a pine rockland designated as NFC to be developed, and requires that the remaining 80 percent be placed under a perpetual covenant. In certain circumstances, where the landowner can demonstrate that limiting development to 20 percent does not allow for “reasonable use” of the property, additional development may be approved. NFC landowners are also required to obtain an NFC permit for any work within the boundaries of the NFC on their property. The NFC program is responsible for ensuring that NFC permits are issued in accordance with the limitations and requirements of the code and that appropriate NFC preserves are established and maintained in conjunction with the issuance of an NFC permit. The NFC program currently regulates approximately 600 pine rockland or pine rockland/hammock properties, comprising approximately 1,200 ha (3,000 ac) of habitat (J. Joyner, 2013, pers. comm.). When RER discovers unpermitted activities, it takes appropriate enforcement action, and seeks restoration when possible. Because these regulations allow for development of pine rockland habitat, and because unpermitted development and destruction of pine rockland continues to occur, the regulations are not fully effective at protecting against loss of Miami tiger beetles or their potential habitat.

Under Miami-Dade County ordinance (section 26-1), a permit is required to conduct scientific research (rule 9) on county environmental lands. In addition, rule 8 of this ordinance provides for the preservation of habitat within County parks or areas operated by the Parks and Recreation Department. The scientific research permitting effectively allows the County to monitor and manage the level of scientific research and collection of the Miami tiger beetle, and the preservation of pine rockland habitat benefits the beetle.

Fee Title Properties: In 1990, Miami-Dade County voters approved a 2-year property tax to fund the acquisition, protection, and maintenance of environmentally endangered lands (EEL). The EEL Program identifies and secures these lands for preservation. Under this program to date, Miami-Dade County has acquired a total of approximately 255 ha (630 ac) of pine rocklands. In addition, approximately 445 ha (1,550 ac) of pine rocklands are owned by the Miami-Dade County Parks and Recreation Department and managed by the EEL Program, including some of the largest remaining areas of pine rockland habitat on the Miami Rock Ridge outside of ENP (e.g., Larry and Penny Thompson Park, Zoo Miami pinelands, and Navy Wells Pineland Preserve) (http://www.miamidade.gov/environment/endangered-lands.asp#1 [Accessed May 11, 2016]). Unfortunately, many of these pine rocklands are not managed to maintain the open, sparsely vegetated areas that are needed by the beetle.

There are some regulatory mechanisms currently in place to protect the Miami tiger beetle and its habitat on non-Federal lands. However, there are no Federal regulatory protections for the Miami tiger beetle, other than the limited protections afforded for listed species and critical habitat that co-occur with the Miami tiger beetle. While local regulations provide some protection, they are generally not fully effective (e.g., NFC regulations allow development of 20 percent or more of pine rockland habitat) or implemented sufficiently (e.g., unpermitted clearing of pine rockland habitat) to alleviate threats to the Miami tiger beetle and its habitat. The degradation of habitat for the Miami tiger beetle is ongoing despite existing regulatory mechanisms. Based on our analysis of the best available information, we find that existing regulatory measures, due to a variety of constraints, are inadequate to fully address threats to the species throughout its range.

The Miami tiger beetle is vulnerable to extinction due to its severely reduced range, the fact that only two small populations remain, and the species' relative isolation.

Demographic stochasticity refers to random variability in survival or reproduction among individuals within a population (Shaffer 1981, p. 131). Demographic stochasticity can have a significant impact on population viability for populations that are small, have low fecundity, and are short-lived. In small populations, reduced reproduction or die-offs of a certain age-class will have a significant effect on the whole population. Although of only minor consequence to large populations, this randomly occurring variation in individuals becomes an important issue for small populations.

Environmental stochasticity is the variation in birth and death rates from one season to the next in response to weather, disease, competition, predation, or other factors external to the population (Shaffer 1981, p. 131). For example, drought or predation, in combination with a low population year, could result in extirpation. The origin of the environmental stochastic event can be natural or human-caused.

In general, tiger beetles that have been regularly monitored consistently exhibit extreme fluctuations in population size, often apparently due to climatic or other habitat factors that affect recruitment, population growth, and other population parameters. In 20 or more years of monitoring, most populations of the northeastern beach and puritan tiger beetles (Cicindela puritan) have exhibited 2 to 5 or more fold differences in abundance (Knisley 2012, entire). Annual population estimates of the Coral Pink Sand Dunes tiger beetle (Cicindela albissima) have ranged from fewer than 600 to nearly 3,000 adults over a 22-year period (Gowan and Knisley 2014, p. 124). The Miami tiger beetle has not been monitored as extensively as these species, but in areas where Miami tiger beetles were repeatedly surveyed, researchers found fluctuations that were several fold in numbers (Knisley 2015a, p. 24). While these fluctuations appear to be the norm for populations of tiger beetles (and most insects), the causes and effects are not well known. Among the suggested causes of these population trends are annual rainfall patterns for the Coral Pink Sand Dunes tiger beetle (Knisley and Hill 2001, p. 391; Gowan and Knisley 2014, p. 119), and shoreline erosion from storms for the northeastern beach and puritan tiger beetles (Knisley 2011b, p. 54). As a result of these fluctuations, many tiger beetle populations will experience episodic low numbers (bottlenecks) or even local extinction from genetic decline, the Allee effect, or other factors. Given that the Miami tiger beetle is known from only two remaining populations with few adult individuals, any significant decrease in the population size could easily result in extinction of the species.

Dispersal and movement of the Miami tiger beetle is unknown, but is considered to be very limited. A limited mark-recapture study with the closely related Highlands tiger beetle found that adult beetles moved no more than 150 m (490 ft), usually flying only 5-10 m (16-33 ft) at a time (Knisley and Hill 2013). Generally, tiger beetles are known to easily move around, so exchange of individuals among separated sites will commonly occur if there are habitat connections or if the sites are within dispersal range—which is not the case with the population structure of the Miami tiger beetle. Species in woodland, scrub, or dune habitats also seem to disperse less than water-edge species (Knisley and Hill 1996, p. 13). Among tiger beetles, there is a general trend of decreasing flight distance with decreasing body size (Knisley and Hill 1996, p. 13). The Miami tiger beetle has a small body size. Given these factors, dispersal may be limited for the Miami tiger beetle.

Small, isolated population size was listed as one of several of the threats in the petition received to list the Miami tiger beetle (CBD et al. 2014, pp. 17, 30). The effects of low population size on population viability are not known for tiger beetles, but population viability analyses for the northeastern beach, puritan, and Coral Pink Sand Dunes tiger beetles determined that stochasticity, specifically the fluctuations in population size, was the main factor accounting for the high risk of extinction (Gowan and Knisley 2001, entire; 2005, p. 13; Knisley and Gowan 2009, pp. 13-23). The long-term monitoring of northeastern beach and puritan tiger beetles found that, despite the fluctuations, some small populations with fewer than 50 to 100 adults experienced several fold declines, but persisted (Knisley 2015b, p. 20). Several Highlands tiger beetle sites with fewer than 20 to 50 adults were lost over the past 15-20 years, while several others have persisted during that period (Knisley 2015b, p. 20). Losses may have been due to habitat disturbance or low population size effects. Knisley predicts that the Highlands tiger beetle populations (extinct and extant) are isolated from each other with little chance for dispersal between populations and immigration rescues (Knisley, 2015d, pers. comm.). With only two known populations of the Miami tiger beetle, separated by substantial urban development, the potential for immigration rescue is low.

Pesticides used in and around pine rockland habitat are a potential threat to the Miami tiger beetle through direct exposure to adults and larvae, secondary exposure from insect prey, overall reduction in availability of adult and larval prey, or any combination of these factors. The use of pesticides for agriculture and mosquito control presents potential risks to nontarget insects, especially imperiled insects (EPA 2002, p. 32; 2006a, p. 58; 2006b, p. 44). The negative effect of insecticides on several tiger beetle species was suggested by Nagano (1982, p. 34) and Stamatov (1972, p. 78), although impacts from pesticides do not appear to be well studied in tiger beetles.

Efforts to control mosquitoes and other insect pests in Florida have increased as human activity and population size have increased. To control mosquito populations, organophosphate (naled) and pyrethroid (permethrin) adulticides are applied by mosquito control districts throughout south Florida, including Miami-Dade County. These compounds have been characterized as being highly toxic to nontarget insects by the U.S. Environmental Protection Agency (2002, p. 32; 2006a, p. 58; 2006b, p. 44). The use of such pesticides (applied using both aerial and ground-based methods) for mosquito control presents a potential risk to the Miami tiger beetle, and this risk may increase with the spread of any mosquito-borne disease, such as the Zika virus, as current guidelines to incorporate no-spray buffers around butterfly critical habitat are not necessarily adhered to if there is a public health concern (Florida Administrative Code 5E-13.036; Service 2015, entire).

In order for mosquito control pesticides to be effective, they must make direct contact with mosquitoes. For this to happen, pesticides are applied using methods to promote drift through the air, so as to increase the potential for contact with their intended target organism. Truck-based permethrin application methods are expected to produce a swath of suspended pesticides approximately 91 m (300 ft) wide (Prentiss 2007, p. 4). The extent of pesticide drift from this swath is dependent on several factors, including wind speed, wind direction, and vegetation density. Hennessey and Habeck (1989, pp. 1-22; 1991, pp. 1-68) and Hennessey et al. (1992, pp. 715-721) illustrated the presence of mosquito spray residues long after application in habitat of the federally endangered Schaus swallowtail butterfly (Heraclides aristodemus ponceanus), as well as the Florida leafwing butterfly (Anaea troglodyta floridalis), Bartram's scrub-hairstreak butterfly, and other imperiled species. Residues of aerially applied naled were found 6 hours after application in a pineland area that was 750 m (2,460 ft) from the target area; residues of fenthion (an adulticide previously used in the Florida Keys) applied via truck were found up to 50 m (160 ft) downwind in a hammock area 15 minutes after application in adjacent target areas (Hennessey et al. 1992, pp. 715-721).

More recently, Pierce (2009, pp. 1-17) monitored naled and permethrin deposition following mosquito control application. Permethrin, applied by truck, was found to drift considerable distances from target areas, with residues that persisted for weeks. Permethrin was detected at concentrations lethal to three butterfly species at a distance of approximately 227 m (745 ft) away from targeted truck routes. Naled, applied by plane, was also found to drift into nontarget areas, but was much less persistent, exhibiting a half-life (time for half of the naled applied to chemically break down) of approximately 6 hours. To expand this work, Pierce (2011, pp. 6-11) conducted an additional deposition study in 2010, focusing on permethrin drift from truck spraying, and again documented low but measurable amounts of permethrin in nontarget areas. In 2009, Bargar (2012, p. 3) conducted two field trials that detected significant naled residues at locations within nontarget areas up to 366 m (1,200 ft) from the edge of zones targeted for aerial applications. After this discovery, the Florida Keys Mosquito Control District recalibrated the on-board model (Wingman, which provides flight guidance and flow rates). Naled deposition was reduced in some of the nontarget zones following recalibration (Bargar 2012, p. 3).

In addition to mosquito control chemicals entering nontarget areas, the toxic effects of such chemicals to nontarget organisms have also been documented. Lethal effects on nontarget moths and butterflies have been attributed to fenthion and naled in both south Florida and the Florida Keys (Emmel 1991, pp. 12-13; Eliazar and Emmel 1991, pp. 18-19; Eliazar 1992, pp. 29-30). Zhong et al. (2010, pp. 1961-1972) investigated the impact of single aerial applications of naled on the endangered Miami blue butterfly (Cyclargus thomasi bethunebakeri) larvae in the field. Survival of butterfly larvae in the target zone was 73.9 percent, which was significantly lower than in both the drift zone (90.6 percent) and the reference (control) zone (100 percent), indicating that direct exposure to naled poses significant risk to Miami blue butterfly larvae. Fifty percent of the samples in the drift zone also exhibited detectable concentrations, once again exhibiting the potential for mosquito control chemicals to drift into nontarget areas. Bargar (2012, p. 4) observed cholinesterase activity depression, to a level shown to cause mortality in the laboratory, in great southern white (Ascia monuste) and Gulf fritillary butterflies (Agraulis vanillae) exposed to naled in both target and nontarget zones.

Based on these studies, it can be concluded that mosquito control activities that involve the use of both aerial and ground-based spraying methods have the potential to deliver pesticides in quantities sufficient to cause adverse effects to nontarget species in both target and nontarget areas. Pesticide drift at a level of concern to nontarget invertebrates (butterflies) has been measured up to approximately 227 m (745 ft) from truck routes (Pierce 2011, pp. 3-5, 7; Rand and Hoang 2010, pp. 14, 23) and 400 m (1,312 ft) from aerial spray zones (Bargar 2012, p. 3). It should be noted that many of the studies referenced above dealt with single application scenarios and examined effects on only one or two butterfly life stages. Under a realistic scenario, the potential exists for exposure to all life stages to occur over multiple applications in a season. In the case of a persistent compound like permethrin, whose residues remain on vegetation for weeks, the potential exists for nontarget species to be exposed to multiple pesticides within a season (e.g., permethrin on vegetation coupled with aerial exposure to naled).

Prior to 2015, aerial applications of mosquito control pesticides occurred on a limited basis (approximately two to four aerial applications per year since 2010) within some of Miami-Dade County's pine rockland areas. The Miami tiger beetle is not known to occupy any of these aerial spray zone sites, but any unknown occupied sites could have been exposed, either directly or through drift. The Richmond Pine Rocklands region is not directly treated either aerially or by truck (C. Vasquez, 2013, pers. comm.), so any potential pesticide exposure in this area would be through drift from spray zones adjacent to the Richmond area. Pesticide drift from aerial spray zones to the two known populations of Miami tiger beetles is unlikely, based on the considerable distance from spray zone boundaries to known occurrences of the beetle (estimated minimum distances range from 2.0-3.0 km (1.2-1.9 mi) from the Richmond population and 434 m (0.3 mi) for the second population). In the past, truck-based applications occurred within 227 m (745 ft) of known occupied Miami tiger beetle habitat, a distance under which pesticide drift at a concentration of concern for nontarget invertebrates had been measured (Pierce 2011, pp. 3-5, 7; Rand and Hoang 2010, pp. 14, 23).

For the 2015 mosquito season (May through October), Miami-Dade Mosquito Control coordinated with the Service to institute 250-m truck-based and 400-m aerial spray buffers around critical habitat for the Bartram's scrub-hairstreak butterfly, with the exclusion of pine rocklands in the Navy Wells area, which is not known to be occupied by the Miami tiger beetle. These newly implemented buffers will also reduce exposure to any other imperiled species occurring on pine rockland habitat within Bartram's scrub-hairstreak butterfly critical habitat, such as the Miami tiger beetle. Assuming that the Miami tiger beetle is no more sensitive to pesticide exposure than the tested butterfly species, these spray buffers should avoid adverse impacts to the Miami tiger beetle population.

Based on Miami-Dade Mosquito Control's implementation of spray buffers, mosquito control pesticides are not considered a major threat for the Miami tiger beetle at this time. If these buffers were to change or Miami tiger beetles were found to occur on habitat that is not protected by Bartram's scrub-hairstreak butterfly critical habitat, then the threat of pesticide exposure would have to be reevaluated.

Human disturbance, depending upon type and frequency, may or may not be a threat to tiger beetles or their habitats. Knisley (2011b, entire) reviewed both the negative and positive effects of human disturbances on tiger beetles. Vehicles, bicycles, and human foot traffic have been implicated in the decline and extirpation of tiger beetle populations, especially for species in more open habitats like beaches and sand dunes. The northeastern beach tiger beetle was extirpated throughout the northeast coincidental with the development of recreational use from pedestrian foot traffic and vehicles (Knisley et al. 1987, p. 301). Habroscelimorpha dorsalis media (southeastern beach tiger beetle) was extirpated from a large section of Assateague Island National Seashore, Maryland, after the initiation of off-highway vehicle (OHV) use (Knisley and Hill, 1992b, p. 134). Direct mortality and indirect effects on habitat from OHVs have been found to threaten the survival of Coral Pink Sand Dunes tiger beetle (Gowan and Knisley 2014, pp. 127-128). The Ohlone tiger beetle has been eliminated from nearly all natural grassland areas in Santa Cruz, California, except where pedestrian foot traffic, mountain bike use, or cattle grazing has created or maintained trails and open patches of habitat (Knisley and Arnold 2013, p. 578). Similarly, over 20 species of tiger beetles, including Cicindela decemnotata (Badlands tiger beetle) at Dugway Proving Ground in Utah, are almost exclusively restricted to roads, trails, and similar areas kept open by vehicle use or similar human disturbances (Knisley 2011b, pp. 44-45).

Vehicle activity on seldom-used roads may have some negative effect on the Miami tiger beetle (i.e., lethal impacts to adults or larvae or impacts to the habitat), but limited field observations to date indicate that effects are minimal (Knisley 2015a, p. 16). Observations in 2014 at Zoo Miami found a few adults along a little-used road and the main gravel road adjacent to interior patches where adults were more common (Knisley 2015a, p. 16). These adults may have dispersed from their primary interior habitat, possibly due to vegetation encroachment (Knisley 2015a, p. 16). Several of the adults at both CSTARS and the USCG parcels were also found along dirt roads that were not heavily used and apparently provided suitable habitat.

The parcels that comprise the two known populations of the Miami tiger beetle are not open to the public for recreational use, so human disturbance is unlikely. For any unknown occurrences of the species, human disturbance from recreational use is a possibility, as some of the remaining pine rockland sites in Miami-Dade County are open to the public for recreational use. Miami-Dade County leads the State in gross urban density at 8,343 people per square mile (https://www.bebr.ufl.edu/population/publications/measuring-population-density-counties-florida [accessed May 18, 2016]), and development and human population growth are expected to continue in the future. By 2025, Miami-Dade County is predicted to near or exceed a population size of 3 million people (Rayer and Wang 2016, p. 7). With the expected future increase in human population and development, there will likely be an increase in the use of recreational areas, including sites with potentially suitable habitat and unknown occurrences of Miami tiger beetles. Projected future increases in recreational use may increase the levels of human disturbance and negatively impact any unknown occurrences of the Miami tiger beetle and their habitat.

In summary, vehicular activity and recreational use within the known population of the Miami tiger beetle presents minimal impacts to the species. However, future negative impacts to unknown beetle occurrences on lands open to the public are possible and are expected to increase with the projected future population growth.

Climatic changes, including sea level rise (SLR), are major threats to Florida, and could impact the Miami tiger beetle and the few remaining parcels of pine rockland habitat left in Miami-Dade County. Our analyses include consideration of ongoing and projected changes in climate. The terms “climate” and “climate change” are defined by the Intergovernmental Panel on Climate Change (IPCC). “Climate” refers to the mean and variability of different types of weather conditions over time, with 30 years being a typical period for such measurements, although shorter or longer periods also may be used (IPCC 2007a, p. 78). 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 natural variability, human activity, or both (IPCC 2007a, p. 78).

Scientific measurements spanning several decades demonstrate that changes in climate are occurring, and that the rate of change has been faster since the 1950s. Based on extensive analyses of global average surface air temperature, the most widely used measure of change, the IPCC concluded that warming of the global climate system over the past several decades is “unequivocal” (IPCC 2007a, p. 2). In other words, the IPCC concluded that there is no question that the world's climate system is warming. Examples of other changes include substantial increases in precipitation in some regions of the world and decreases in other regions (for these and additional examples, see IPCC 2007a, p. 30; Solomon et al. 2007, pp. 35-54, 82-85). Various environmental changes (e.g., shifts in the ranges of plant and animal species, increasing ground instability in permafrost regions, conditions more favorable to the spread of invasive species and of some diseases, changes in amount and timing of water availability) are occurring in association with changes in climate (see IPCC 2007a, pp. 2-4, 30-33; Global Climate Change Impacts in the United States 2009, pp. 27, 79-88).

Results of scientific analyses presented by the IPCC show that most of the observed increase in global average temperature since the mid-20th century cannot be explained by natural variability in climate, and is “very likely” (defined by the IPCC as 90 percent or higher probability) due to the observed increase in greenhouse gas (GHG) concentrations in the atmosphere as a result of human activities, particularly carbon dioxide emissions from fossil fuel use (IPCC 2007a, pp. 5-6 and figures SPM.3 and SPM.4; Solomon et al. 2007, pp. 21-35). Further confirmation of the role of GHGs comes from analyses by Huber and Knutti (2011, p. 4), who concluded it is extremely likely that approximately 75 percent of global warming since 1950 has been caused by human activities.

Scientists use a variety of climate models, which include consideration of natural processes and variability, as well as various scenarios of potential levels and timing of GHG emissions, to evaluate the causes of changes already observed and to project future changes in temperature and other climate conditions (e.g., Meehl et al. 2007, entire; Ganguly et al. 2009, pp. 11555, 15558; Prinn et al. 2011, pp. 527, 529). All combinations of models and emissions scenarios yield very similar projections of average global warming until about 2030. Although projections of the magnitude and rate of warming differ after about 2030, the overall trajectory of all the projections is one of increased global warming through the end of this century, even for projections based on scenarios that assume that GHG emissions will stabilize or decline. Thus, there is strong scientific support for projections that warming will continue through the 21st century, and that the magnitude and rate of change will be influenced substantially by the extent of GHG emissions (IPCC 2007a, pp. 44-45; Meehl et al. 2007, pp. 760-764; Ganguly et al. 2009, pp. 15555-15558; Prinn et al. 2011, pp. 527, 529).

In addition to basing their projections on scientific analyses, the IPCC reports projections using a framework for treatment of uncertainties (e.g., they define “very likely” to mean greater than 90 percent probability, and “likely” to mean greater than 66 percent probability; see Solomon et al. 2007, pp. 22-23). Some of the IPCC's key projections of global climate and its related effects include: (1) It is virtually certain there will be warmer and more frequent hot days and nights over most of the earth's land areas; (2) it is very likely there will be increased frequency of warm spells and heat waves over most land areas; (3) it is very likely that the frequency of heavy precipitation events, or the proportion of total rainfall from heavy falls, will increase over most areas; and (4) it is likely the area affected by droughts will increase, that intense tropical cyclone activity will increase, and that there will be increased incidence of extreme high sea level (IPCC 2007b, p. 8, table SPM.2). More recently, the IPCC published additional information that provides further insight into observed changes since 1950, as well as projections of extreme climate events at global and broad regional scales for the middle and end of this century (IPCC 2011, entire).

Various changes in climate may have direct or indirect effects on species. These may be positive, neutral, or negative, and they may change over time, depending on the species and other relevant considerations, such as interactions of climate with other variables such as habitat fragmentation (for examples, see Franco et al. 2006; IPCC 2007a, pp. 8-14, 18-19; Forister et al. 2010; Galbraith et al. 2010; Chen et al. 2011). In addition to considering individual species, scientists are evaluating possible climate change-related impacts to, and responses of, ecological systems, habitat conditions, and groups of species; these studies include acknowledgement of uncertainty (e.g., Deutsch et al. 2008; Euskirchen et al. 2009; McKechnie and Wolf 2009; Berg et al. 2010; Sinervo et al. 2010; Beaumont et al. 2011; McKelvey et al. 2011; Rogers and Schindler 2011).

Many analyses involve elements that are common to climate change vulnerability assessments. In relation to climate change, vulnerability refers to the degree to which a species (or system) is susceptible to, and unable to cope with, adverse effects of climate change, including climate variability and extremes. Vulnerability is a function of the type, magnitude, and rate of climate change and variation to which a species is exposed, its sensitivity, and its adaptive capacity (IPCC 2007a, p. 89; see also Glick et al. 2011, pp. 19-22). There is no single method for conducting such analyses that applies to all situations (Glick et al. 2011, p. 3). We use our expert judgment and appropriate analytical approaches to weigh relevant information, including uncertainty, in our consideration of various aspects of climate change.

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 2007a, pp. 8-12). 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). For our analysis for the Miami tiger beetle, downscaled projections are available.

According to the Florida Climate Center, Florida is by far the most vulnerable State in the United States to hurricanes and tropical storms (http://climatecenter.fsu.edu/topics/tropical-weather). Based on data gathered from 1856 to 2008, Klotzbach and Gray (2009, p. 28) calculated the climatological probabilities for each State being impacted by a hurricane or major hurricane in all years over the 152-year timespan. Of the coastal States analyzed, Florida had the highest climatological probabilities, with a 51 percent probability of a hurricane (Category 1 or 2) and a 21 percent probability of a major hurricane (Category 3 or higher). From 1856 to 2008, Florida actually experienced more major hurricanes than predicted; out of the 109 hurricanes, 36 were major hurricanes. The most recent hurricane to have major impacts to Miami-Dade County was Hurricane Andrew in 1992. While the species persisted after this hurricane, impacts to the population size and distribution from the storm are unknown, because no surveys were conducted until its rediscovery in 2007. Given the few, isolated populations of the Miami tiger beetle within a location prone to storm influences (located approximately 8 km (5 mi) from the coast), the species is at substantial risk from stochastic environmental events such as hurricanes, storm surges, and other extreme weather that can affect recruitment, population growth, and other population parameters.

Other processes to be affected by climate change, related to environmental stochasticity, include temperatures, rainfall (amount, seasonal timing, and distribution), and storms (frequency and intensity). Temperatures are projected to rise from 2-5 degrees Celsius (°C) (3.6-9 degrees Fahrenheit (°F)) for North America by the end of this century (IPCC 2007a, pp. 7-9, 13). Based upon predictive modeling, Atlantic hurricane and tropical storm frequencies are expected to decrease (Knutson et al. 2008, pp. 1-21). By 2100, there should be a 10-30 percent decrease in hurricane frequency. Hurricane frequency is expected to drop, due to more wind shear impeding initial hurricane development. However, hurricane winds are expected to increase by 5-10 percent. This is due to more hurricane energy available for intense hurricanes. These stronger winds will result in damage to the pine rockland vegetation and an increased storm surge (discussed below). In addition to climate change, weather variables are extremely influenced by other natural cycles, such as El Niño Southern Oscillation, with a frequency of every 4-7 years; solar cycle (every 11 years); and the Atlantic Multi-decadal Oscillation. All of these cycles influence changes in Floridian weather. The exact magnitude, direction, and distribution of all of these changes at the regional level are difficult to project.

The long-term record at Key West shows that sea level rose on average 0.229 cm (0.090 in) annually between 1913 and 2013 (National Oceanographic and Atmospheric Administration (NOAA) 2013, p. 1). This equates to approximately 22.9 cm (9.02 in) over the last 100 years. IPCC (2008, p. 28) emphasized it is very likely that the average rate of SLR during the 21st century will exceed the historical rate. The IPCC Special Report on Emission Scenarios (2000, entire) presented a range of scenarios based on the computed amount of change in the climate system due to various potential amounts of anthropogenic greenhouse gases and aerosols in 2100. Each scenario describes a future world with varying levels of atmospheric pollution, leading to corresponding levels of global warming and corresponding levels of SLR. The IPCC Synthesis Report (2007a, entire) provided an integrated view of climate change and presented updated projections of future climate change and related impacts under different scenarios.

Subsequent to the 2007 IPCC Report, the scientific community has continued to model SLR. Recent peer-reviewed publications indicate a movement toward increased acceleration of SLR. Observed SLR rates are already trending along the higher end of the 2007 IPCC estimates, and it is now widely held that SLR will exceed the levels projected by the IPCC (Rahmstorf et al. 2012, p. 1; Grinsted et al. 2010, p. 470). Taken together, these studies support the use of higher end estimates now prevalent in the scientific literature. Recent studies have estimated global mean SLR of 1.0-2.0 m (3.3-6.6 ft) by 2100 as follows: 0.75-1.90 m (2.5-6.2 ft; Vermeer and Rahmstorf 2009, p. 21530), 0.8-2.0 m (2.6-6.6 ft; Pfeffer et al. 2008, p. 1342), 0.9-1.3 m (3.0-4.3 ft; Grinsted et al. 2010, pp. 469-470), 0.6-1.6 m (2.0-5.2 ft; Jevrejeva et al. 2010, p. 4), and 0.5-1.40 m (1.6-4.6 ft; National Research Council 2012, p. 2).

All of the scenarios, from small climate change shifts to major changes, indicate negative effects on pine rockland habitat throughout Miami-Dade County. Prior to inundation, pine rocklands are likely to undergo habitat transitions related to climate change, including changes to hydrology and increasing vulnerability to storm surge. Hydrology has a strong influence on plant distribution in these and other coastal areas (IPCC 2008, p. 57). Such communities typically grade from salt to brackish to freshwater species. From the 1930s to 1950s, increased salinity of coastal waters contributed to the decline of cabbage palm forests in southwest Florida (Williams et al. 1999, pp. 2056-2059), expansion of mangroves into adjacent marshes in the Everglades (Ross et al. 2000, pp. 101, 111), and loss of pine rockland in the Keys (Ross et al. 1994, pp. 144, 151-155).

In one Florida Keys pine rockland with an average elevation of 0.89 m (2.9 ft), Ross et al. (1994, pp. 149-152) observed an approximately 65 percent reduction in an area occupied by South Florida slash pine over a 70-year period, with pine mortality and subsequent increased proportions of halophytic (salt-loving) plants occurring earlier at the lower elevations. During this same time span, local sea level had risen by 15.0 cm (6.0 in), and Ross et al. (1994, p. 152) found evidence of groundwater and soil water salinization. Extrapolating this situation to pine rocklands on the mainland is not straightforward, but suggests that similar changes to species composition could arise if current projections of SLR occur and freshwater inputs are not sufficient to prevent salinization.

Furthermore, Ross et al. (2009, pp. 471-478) suggested that interactions between SLR and pulse disturbances (e.g., storm surges) can cause vegetation to change sooner than projected based on sea level alone. Effects from vegetation shifts in the pine rockland habitat on the Miami tiger beetle are unknown, but because the beetle occurs in a narrow range and microhabitat parameters are still being studied, vegetation shifts could cause habitat changes or disturbance that would have a negative impact on beetle recruitment and survival. Alexander (1953, pp. 133-138) attributed the demise of pinelands on northern Key Largo to salinization of the groundwater in response to SLR. Patterns of human development will also likely be significant factors influencing whether natural communities can move and persist (IPCC 2008, p. 57; USCCSP 2008, p. 76).

The Science and Technology Committee of the Miami-Dade County Climate Change Task Force (Wanless et al. 2008, p. 1) recognized that significant SLR is a very real threat to the near future for Miami-Dade County. In a January 2008 statement, the committee warned that sea level is expected to rise at least 0.9-1.5 m (3-5 ft) within this century (Wanless et al. 2008, p. 3). With a 0.9-1.2 m (3-4 ft) rise in sea level (above baseline) in Miami-Dade County: “Spring high tides would be at about 6 to 7 ft; freshwater resources would be gone; the Everglades would be inundated on the west side of Miami-Dade County; the barrier islands would be largely inundated; storm surges would be devastating; landfill sites would be exposed to erosion contaminating marine and coastal environments. Freshwater and coastal mangrove wetlands will not keep up with or offset SLR of 0.6 m (2 ft) per century or greater. With a 1.5-m (5-ft) rise (spring tides at ~2.4 m (~8 ft)), Miami-Dade County will be extremely diminished” (Wanless et al. 2008, pp. 3-4).

Drier conditions and increased variability in precipitation associated with climate change are expected to hamper successful regeneration of forests and cause shifts in vegetation types through time (Wear and Greis 2012, p. 39). Although it has not been well studied, existing pine rocklands have probably been affected by reductions in the mean water table. Climate changes are also forecasted to extend fire seasons and the frequency of large fire events throughout the Coastal Plain (Wear and Greis 2012, p. 43). While restoring fire to pine rocklands is essential to the long-term viability of the Miami tiger beetle (see Factor A discussion, above), increases in the scale, frequency, or severity of wildfires could have negative effects on the species (e.g., if wildfire occurs over the entire area occupied by the two known populations during the adult flight season when adults are present).

To accommodate the large uncertainty in SLR projections, researchers must estimate effects from a range of scenarios. Various model scenarios developed at Massachusetts Institute of Technology (MIT) and GeoAdaptive Inc. have projected possible trajectories of future transformation of the south Florida landscape by 2060, based upon four main drivers: Climate change, shifts in planning approaches and regulations, human population change, and variations in financial resources for conservation (Vargas-Moreno and Flaxman 2010, pp. 1-6). The scenarios do not account for temperature, precipitation, or species habitat shifts due to climate change, and no storm surge effects are considered. The current MIT scenarios range from an increase of 0.09-1.00 m (0.3-3.3 ft) by 2060.

Based on the most recent estimates of SLR and the data available to us at this time, we evaluated potential effects of SLR using the current “high” range MIT scenario, as well as comparing elevations of remaining pine rockland fragments and extant occurrences of the Miami tiger beetle. The “high” range (or “worst case”) MIT scenario assumes high SLR (1.0 m (3.3 ft) by 2060), low financial resources, a `business as usual' approach to planning, and a doubling of human population. Based on this scenario, pine rocklands along the coast in central Miami-Dade County would become inundated. The “new” sea level (1.0 m (3.3 ft) higher) would come up to the edge of pine rockland fragments at the southern end of Miami-Dade County, translating to partial inundation or, at a minimum, vegetation shifts for these pine rocklands. While sea level under this scenario would not overtake other pine rocklands in urban Miami-Dade County, including the known locations for the Miami tiger beetle, changes in the salinity of the water table and soils would surely cause vegetation shifts that may negatively impact the viability of the beetle. In addition, many existing pine rockland fragments are projected to be developed for housing as the human population grows and adjusts to changing sea levels under this “high” range (or “worst case”) MIT scenario. Actual impacts may be greater or less than anticipated based upon high variability of factors involved (e.g., SLR, human population growth) and assumptions made in the model.

When simply looking at current elevations of pine rockland fragments and occurrences of the Miami tiger beetle, it appears that an SLR of 1 m (3.3 ft) will inundate the coastal and southern pine rocklands and cause vegetation shifts largely as described above. SLR of 2 m (6.6 ft) appears to inundate much larger portions of urban Miami-Dade County. The western part of urban Miami-Dade County would also be inundated (barring creation of sea walls or other barriers), creating a virtual island of the Miami Rock Ridge. After a 2-m rise in sea level, approximately 75 percent of the remaining pine rockland would still be above sea level, but an unknown percentage of these fragments would be negatively impacted by salinization of the water table and soils, which would be exacerbated due to isolation from mainland fresh water flows. Above 2 m (6.6 ft) of SLR, very little pine rockland would remain, with the vast majority either being inundated or experiencing vegetation shifts.

The climate of southern Florida is driven by a combination of local, regional, and global events, regimes, and oscillations. There are three main “seasons”: (1) The wet season, which is hot, rainy, and humid from June through October; (2) the official hurricane season that extends 1 month beyond the wet season (June 1 through November 30), with peak season being August and September; and (3) the dry season, which is drier and cooler, from November through May. In the dry season, periodic surges of cool and dry continental air masses influence the weather with short-duration rain events followed by long periods of dry weather.

Climate change may lead to increased frequency and duration of severe storms (Golladay et al. 2004, p. 504; McLaughlin et al. 2002, p. 6074; Cook et al. 2004, p. 1015). Hurricanes and tropical storms can modify habitat (e.g., through storm surge) and have the potential to destroy the only known population of the Miami tiger beetle and its suitable habitat. With most of the historical habitat having been destroyed or modified, the two known remaining populations of the beetle are at high risk of extirpation due to stochastic events.

The Miami tiger beetle is anticipated to face major risks from coastal squeeze, which occurs when habitat is pressed between rising sea levels and coastal development that prevents landward movement (Scavia et al. 2002, entire; FitzGerald et al. 2008, entire; Defeo et al. 2009, p. 8; LeDee et al. 2010, entire; Menon et al. 2010, entire; Noss 2011, entire). Habitats in coastal areas (i.e., Charlotte, Lee, Collier, Monroe, Miami-Dade Counties) are likely the most vulnerable. Although it is difficult to quantify impacts due to the uncertainties involved, coastal squeeze will likely result in losses in habitat for the beetles as people and development are displaced further inland.

Based on our analysis of the best available information, we have identified a wide array of natural and manmade factors affecting the continued existence of the Miami tiger beetle. The beetle is immediately vulnerable to extinction, due to the effects of few remaining small populations, restricted range, and isolation. Aspects of the Miami tiger beetle's natural history (e.g., limited dispersal) and environmental stochasticity (including hurricanes and storm surge) may also contribute to imperilment. Other natural (e.g., changes to habitat, invasive and exotic vegetation) and anthropogenic (e.g., habitat alteration, impacts from humans) factors are also identifiable threats. Climate change, sea-level rise, and coastal squeeze are major concerns. Collectively, these threats have occurred in the past, are impacting the species now, and will continue to impact the species in the future.

The limited distribution, small population size, few populations, and relative isolation of the Miami tiger beetle makes it extremely susceptible to further habitat loss, modification, degradation, and other anthropogenic threats. The Miami tiger beetle's viability at present is uncertain, and its continued persistence is in danger, unless protective actions are taken. Mechanisms causing the decline of this beetle, as discussed above, range from local (e.g., lack of adequate fire management, vegetation encroachment), to regional (e.g., development, fragmentation, nonnative species), to global influences (e.g., climate change, SLR). The synergistic effects of threats (such as hurricane effects on a species with a limited distribution consisting of just two known populations) make it difficult to predict population viability now and in the future. While these stressors may act in isolation, it is more probable that many stressors are acting simultaneously (or in combination) on the Miami tiger beetle.

We have carefully assessed the best scientific and commercial information available regarding the past, present, and future threats to the Miami tiger beetle. Habitat loss, degradation, and fragmentation have destroyed an estimated 98 percent of the historical pine rockland habitat in Miami-Dade County, with only two known populations remaining. The threat of habitat loss is continuing from development, inadequate habitat management resulting in vegetation encroachment, and environmental effects resulting from climatic change (see discussions under Factors A and E). Due to the restricted range, small population size, few populations, and relative isolation (see Factor E), collection is a significant threat to the species and could potentially occur at any time (see discussions under Factor B). Additionally, the species is currently threatened by a wide array of natural and manmade factors (see Factor E). Existing regulatory mechanisms do not provide adequate protection for the species (see Factor D). As a result, impacts from increasing threats, singly or in combination, are likely to result in the extinction of the species because the magnitude of threats is high.

The Act defines an endangered species as any species that is “in danger of extinction throughout all or a significant portion of its range” and a threatened species as any species “that is likely to become endangered throughout all or a significant portion of its range within the foreseeable future.” We find that the Miami tiger beetle is presently in danger of extinction throughout its entire range based on the severity and immediacy of threats currently affecting the species. The overall range has been significantly impacted because of significant habitat loss, degradation, and fragmentation of pine rockland habitat. Newly proposed development is currently threatening one of only two known populations of this species. The fragmented nature of Miami-Dade County's remaining pine rockland habitat and the influx of development around them may preclude the ability to conduct prescribed burns or other beneficial management actions that are needed to prevent vegetation encroachment. The two known, small populations of the Miami tiger beetle appear to occupy relatively small habitat patches, which make them vulnerable to local extinction from normal fluctuations in population size, genetic problems from small population size, or environmental catastrophes. Limited dispersal abilities in combination with limited habitat may result in local extirpations.

Therefore, on the basis of the best available scientific and commercial information, we are listing the Miami tiger beetle as endangered in accordance with sections 3(6) and 4(a)(1) of the Act. We find that a threatened species status is not appropriate for the Miami tiger beetle because of significant habitat loss (i.e., 98 percent of pine rockland habitat in Miami-Dade County) and degradation; the fact that only two known small populations of the species remain; and the imminent threat of development projects in the Richmond pine rocklands.

Under the Act and our implementing regulations, a species may warrant listing if it is endangered or threatened throughout all or a significant portion of its range. Because we have determined that the Miami tiger beetle is endangered throughout all of its range, no portion of its range can be “significant” for purposes of the definitions of “endangered species” and “threatened species.” See the Final Policy on Interpretation of the Phrase “Significant Portion of Its Range” in the Endangered Species Act's Definitions of “Endangered Species” and “Threatened Species” (79 FR 37577).

Conservation measures provided to species listed as endangered or threatened species under the Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing results in public awareness and conservation by Federal, State, Tribal, and local agencies, private organizations, and individuals. The Act encourages cooperation with the States and requires that recovery actions be carried out for all listed species. The protection required by Federal agencies and the prohibitions against certain activities are discussed, in part, below.

The primary purpose of the Act is the conservation of endangered and threatened species and the ecosystems upon which they depend. The ultimate goal of such conservation efforts is the recovery of these listed species, so that they no longer need the protective measures of the Act. Subsection 4(f) of the Act requires the Service to develop and implement recovery plans for the conservation of endangered and threatened species. The recovery planning process involves the identification of actions that are necessary to halt or reverse the species' decline by addressing the threats to its survival and recovery. The goal of this process is to restore listed species to a point where they are secure, self-sustaining, and functioning components of their ecosystems.

Recovery planning includes the development of a recovery outline shortly after a species is listed and preparation of a draft and final recovery plan. The recovery outline guides the immediate implementation of urgent recovery actions and describes the process to be used to develop a recovery plan. Revisions of the plan may be done to address continuing or new threats to the species, as new substantive information becomes available. The recovery plan identifies site-specific management actions that set a trigger for review of the five factors that control whether a species remains endangered or may be downlisted or delisted, and methods for monitoring recovery progress. Recovery plans also establish a framework for agencies to coordinate their recovery efforts and provide estimates of the cost of implementing recovery tasks. Recovery teams (composed of species experts, Federal and State agencies, nongovernmental organizations, and stakeholders) are often established to develop recovery plans. When completed, the recovery outline, draft recovery plan, and the final recovery plan will be available on our Web site (http://www.fws.gov/endangered) or from our South Florida Ecological Services Office (see FOR FURTHER INFORMATION CONTACT).

Implementation of recovery actions generally requires the participation of a broad range of partners, including other Federal agencies, States, Tribal, nongovernmental organizations, businesses, and private landowners. Examples of recovery actions include habitat restoration (e.g., restoration of native vegetation), research, captive propagation and reintroduction, and outreach and education. The recovery of many listed species cannot be accomplished solely on Federal lands because their range may occur primarily or solely on non-Federal lands. To achieve recovery of these species requires cooperative conservation efforts on private, State, and Tribal lands.

Following publication of this final listing rule, funding for recovery actions will be available from a variety of sources, including Federal budgets, State programs, and cost-share grants for non-Federal landowners, the academic community, and nongovernmental organizations. In addition, pursuant to section 6 of the Act, the State of Florida will be eligible for Federal funds to implement management actions that promote the protection or recovery of the Miami tiger beetle. Information on our grant programs that are available to aid species recovery can be found at: http://www.fws.gov/grants.

Please let us know if you are interested in participating in recovery efforts for the Miami tiger beetle. Additionally, we invite you to submit any new information on this species whenever it becomes available and any information you may have for recovery planning purposes (see FOR FURTHER INFORMATION CONTACT).

Section 7(a) of the Act requires Federal agencies to evaluate their actions with respect to any species that is listed as an endangered or threatened species and with respect to its critical habitat, if any is designated. Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR part 402. Section 7(a)(2) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of any endangered or threatened species or destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into consultation with the Service.

Federal agency actions within the species' habitat that may require conference or consultation or both as described in the preceding paragraph include management and any other landscape-altering activities on Federal lands administered by the U.S. Coast Guard; issuance of section 404 Clean Water Act permits by the Army Corps of Engineers; and construction and maintenance of roads or highways by the Federal Highway Administration.

The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to endangered wildlife. The prohibitions of section 9(a)(1) of the Act, codified at 50 CFR 17.21, make it illegal for any person subject to the jurisdiction of the United States to take (which includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or to attempt any of these) endangered wildlife within the United States or on the high seas. In addition, it is unlawful to import; export; deliver, receive, carry, transport, or ship in interstate or foreign commerce in the course of commercial activity; or sell or offer for sale in interstate or foreign commerce any listed species. It is also illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken illegally. Certain exceptions apply to employees of the Service, the National Marine Fisheries Service, other Federal land management agencies, and State conservation agencies.

We may issue permits to carry out otherwise prohibited activities involving endangered wildlife under certain circumstances. Regulations governing permits are codified at 50 CFR 17.22. With regard to endangered wildlife, a permit may be issued for the following purposes: For scientific purposes, to enhance the propagation or survival of the species, and for incidental take in connection with otherwise lawful activities. There are also certain statutory exemptions from the prohibitions, which are found in sections 9 and 10 of the Act.

It is our policy, as published in the Federal Register on July 1, 1994 (59 FR 34272), to identify to the maximum extent practicable at the time a species is listed, those activities that would or would not constitute a violation of section 9 of the Act. The intent of this policy is to increase public awareness of the effect of a final listing on proposed and ongoing activities within the range of a listed species. Based on the best available information, the following actions may potentially result in a violation of section 9, of the Act; this list is not comprehensive:

(1) Unauthorized possession, collecting, trapping, capturing, killing, harassing, sale, delivery, or movement, including interstate and foreign commerce, or harming or attempting any of these actions, at any life stage without a permit (research activities where Miami tiger beetles are surveyed, captured (netted), or collected will require a permit under section 10(a)(1)(A) of the Act).

(2) Incidental take without a permit pursuant to section 10(a)(1)(B) of the Act.

(3) Sale or purchase of specimens, except for properly documented antique specimens of this taxon at least 100 years old, as defined by section 10(h)(1) of the Act.

(4) Unauthorized use of pesticides/herbicides that results in take.

(5) Release of biological control agents that attack any life stage.

(6) Discharge or dumping of toxic chemicals, silts, or other pollutants into, or other alteration of the quality of, habitat supporting the Miami tiger beetles that result in take.

(7) Unauthorized activities (e.g., plowing; mowing; burning; herbicide or pesticide application; land leveling/clearing; grading; disking; soil compaction; soil removal; dredging; excavation; deposition of dredged or fill material; erosion and deposition of sediment/soil; grazing or trampling by livestock; minerals extraction or processing; residential, commercial, or industrial developments; utilities development; road construction; or water development and impoundment) that take eggs, larvae, or adult Miami tiger beetles or that modify Miami tiger beetle habitat in such a way that take Miami tiger beetles by adversely affecting their essential behavioral patterns, including breeding, foraging, sheltering, or other life functions. Otherwise lawful activities that incidentally take Miami tiger beetles, but have no Federal nexus, will require a permit under section 10(a)(1)(B) of the Act.

Questions regarding whether specific activities would constitute a violation of section 9 of the Act should be directed to the South Florida Ecological Services Office (see FOR FURTHER INFORMATION CONTACT).

Section 3(5)(A) of the Act defines critical habitat as “(i) the specific areas within the geographical area occupied by the species, at the time it is listed . . . on which are found those physical or biological features (I) essential to the conservation of the species and (II) which may require special management considerations or protection; and (ii) specific areas outside the geographical area occupied by the species at the time it is listed . . . upon a determination by the Secretary that such areas are essential for the conservation of the species.” Section 3(3) of the Act (16 U.S.C. 1532(3)) also defines the terms “conserve,” “conserving,” and “conservation” to mean “to use and the use of all methods and procedures which are necessary to bring any endangered species or threatened species to the point at which the measures provided pursuant to this chapter are no longer necessary.”

In the proposed listing rule (80 FR 79533, December 22, 2015), we determined that designation of critical habitat for the Miami tiger beetle was prudent. See the Prudency Determination in the proposed rule for more information.

Once we determine that the designation is prudent, we must find whether critical habitat for Cicindelidia floridana is determinable. Our regulations (50 CFR 424.12(a)(2)) state that critical habitat is not determinable when one or both of the following situations exists: (1) Information sufficient to perform required analysis of the impacts of the designation is lacking; or (2) the biological needs of the species are not sufficiently well known to permit identification of an area as critical habitat.

In our proposed listing rule, we found that critical habitat was not determinable because the specific information sufficient to perform the required analysis of the impacts of the designation was lacking. We are still in the process of obtaining that information, but anticipate that a proposed rule designating critical habitat for the Miami tiger beetle will be published before the end of fiscal year 2017.

We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act (NEPA), need not be prepared in connection with listing a species as an endangered or threatened species under the Endangered Species Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

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. 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 not aware of any Cicindelida floridana populations on tribal lands.

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

The primary authors of this final rule are the staff members of the South Florida Ecological Services Field Office.

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

The snapper-grouper fishery of the South Atlantic includes vermilion snapper and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

The commercial quota for vermilion snapper in the South Atlantic is divided into separate quotas for two 6-month time periods each year, January through June and July through December. For the July through December 2016 period, the commercial quota is 388,703 lb (176,313 kg), gutted weight (431,460 lb (195,707 kg), round weight), as specified in 50 CFR 622.190(a)(4)(ii)(D).

On August 25, 2016 (81 FR 58411), NMFS published a temporary rule in the Federal Register to reduce the commercial trip limit for vermilion snapper in or from the EEZ of the South Atlantic to 500 lb (227 kg), gutted weight. The temporary rule was effective at 12:01 a.m., local time, August 28, 2016, until January 1, 2017, or until the commercial quota is reached and the commercial sector closes, whichever occurs first.

In accordance with regulations at 50 CFR 622.193(f)(1), NMFS is required to close the commercial sector for vermilion snapper when the commercial quota for that 6-month portion of the fishing year is reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined that the commercial quota for South Atlantic vermilion snapper for the July through December 2016 period will be reached by October 11, 2016. Accordingly, the commercial sector for South Atlantic vermilion snapper is closed effective 12:01 a.m., local time, October 11, 2016, until 12:01 a.m., local time, January 1, 2017. The commercial quota for vermilion snapper in the South Atlantic is 388,703 lb (176,313 kg), gutted weight (431,460 lb (195,707 kg), round weight), for the January 1 through June 30, 2017 period as specified in 50 CFR 622.190(a)(4)(i)(D).

The operator of a vessel with a valid commercial vessel permit for South Atlantic snapper-grouper having vermilion snapper onboard must have landed and bartered, traded, or sold such vermilion snapper prior to 12:01 a.m., local time, October 11, 2016. During the closure, the bag limit specified in 50 CFR 622.187(b)(5) and the possession limits specified in 50 CFR 622.187(c)(1), apply to all harvest or possession of vermilion snapper in or from the South Atlantic EEZ. During the closure, the sale or purchase of vermilion snapper taken from the EEZ is prohibited. As specified in 50 CFR 622.190(c)(1)(i), the prohibition on sale or purchase does not apply to the sale or purchase of vermilion snapper that were harvested, landed ashore, and sold prior to 12:01 a.m., local time, October 11, 2016, and were held in cold storage by a dealer or processor. For a person on board a vessel for which a Federal commercial or charter vessel/headboat permit for the South Atlantic snapper-grouper fishery has been issued, the bag and possession limits and the prohibition on sale and purchase apply regardless of whether the fish are harvested in state or Federal waters, as specified in 50 CFR 622.190(c)(1)(ii).

The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of South Atlantic vermilion snapper and is consistent with the Magnuson-Stevens Act and other applicable laws.

This action is taken under 50 CFR 622.193(f)(1) and is exempt from review under Executive Order 12866.

These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.

This action responds to the best scientific information available. The Assistant Administrator for NOAA Fisheries (AA) finds that the need to immediately implement this action to close the commercial sector for vermilion snapper constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures are unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule implementing the AMs has already been subject to notice and comment, and all that remains is to notify the public of the closure. Allowing prior notice and opportunity for public comment is contrary to the public interest because of the need to immediately implement this action to protect vermilion snapper since the capacity of the fishing fleet allows for rapid harvest of the commercial quota. Prior notice and opportunity for public comment could result in a harvest well in excess of the established commercial quota.

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