Federal Register Vol. 80, No.210,

On November 13, 2014, OPM published proposed regulations in the Federal Register (79 FR 67377—67379) to (1) Expand the definition of “qualified relative” under 5 U.S.C. 9001(5)(D) to include both same-sex and opposite-sex domestic partners of Federal and U.S. Postal Service employees and annuitants and members and retired members of the uniformed services; (2) expand the definition of “qualified relative” to include adult children of domestic partners of Federal and U.S. Postal Service employees and annuitants, and members and retired members of the uniformed services; (3) allow the workforce member or his or her domestic partner to provide notice to the employing office if at any time between the time of application and the time coverage is scheduled to go into effect, any of the conditions for a domestic partnership are no longer met, in which case a domestic partnership is deemed terminated; (4) require domestic partners to provide documentation to establish that they meet the criteria for domestic partnership; (5) clarify that once coverage has begun, termination of a domestic partnership does not terminate a domestic partner's insurance coverage as long as the Carrier continues to receive the required premium when due; and (6) make other technical conforming amendments to the FLTCIP rules in connection with the extension of coverage to domestic partners and to adult children of domestic partners.

Comments were requested to be received on or before January 12, 2015. After reviewing the comments received OPM is issuing the final regulation as proposed.

We received three comments on the proposed rule. All commenters expressed support for the proposed rule that extends important coverage to domestic partners and to children of domestic partners under the FLTCIP. One commenter approved the wording of the proposed rule with no suggested changes and this comment is not addressed. Below, please find our response to the remaining two comments we received.

Comment: The commenter had concerns as to the wording or the implications of this expansion primarily concerning states that do not recognize domestic partnerships, and requested to know how eligibility would be treated for qualified partners in states that do not recognize domestic partnerships. The commenter requested to know whether a couple that is considered, and could register as a domestic partnership in one state would be deemed ineligible in a state that does not recognize and does not register domestic partnerships or whether this would prohibit same-sex partnerships in states that prevent same-sex marriage. This commenter also noted that the FLTCIP regulation explains that one would not be deemed eligible if related in a way that would prohibit legal marriage in the U.S. jurisdiction in which the domestic partnership was formed and requested further clarification of how would this impact same-sex domestic partnerships in states that prevent same-sex marriage.

Response: The proposed and final regulations expand the definition of “qualified relative” to cover all individuals who are domestic partners (both same-sex and opposite-sex) of Federal and U.S. Postal Service employees, annuitants, members of the uniformed services, and retired members of the uniformed services no matter their state of residence. The regulation allows coverage for individuals who certify to their employing office that they meet the criteria in the regulatory definition of domestic partnership. The requirement in paragraph (v)(ii) of the definition of domestic partnership does not prevent those who reside in states that prohibit same-sex marriage to register as domestic partners. The requirement is meant to prevent those who are related by blood to certify to a domestic partnership as determined by their state of residence. This requirement already applies to same-sex domestic partners who can currently apply for coverage.

Comment: The commenter recommended that we amend the proposed rulemaking to ensure that all children of same-sex parents are eligible to access FLTCIP Benefits, regardless of their parents' ability to marry. The commenter stated that this can be achieved by redefining an eligible child to include the child of a person standing in loco parentis, where in loco parentis means those persons with day-to-day responsibilities to care for and financially support a child, and with whom a biological or legal relationship is not necessary.

Response: The proposed rule clarifies that OPM intends for children of domestic partners to be treated the same as currently eligible individuals. The eligibility of the stepchild does not depend upon the parent's ability to marry. The FLTCIP regulation provides that a “stepchild,” as defined in the proposed rule, may qualify for FLTCIP coverage as a qualified relative, if all eligibility requirements are met. The stepchild must be the child of the spouse or domestic partner of an employee, annuitant, member of the uniformed services, or retired member of the uniformed services. The stepchild(ren) may apply for coverage even if the employee does not apply, and his or her eligibility for FLTICP coverage is determined independent of the workforce member's ability to marry.

I certify that this regulation will not have a significant economic impact on a substantial number of small entities because the regulation only adds additional groups to the list of groups eligible to apply for coverage under the FLTCIP. The FLTCIP is a voluntary, self-pay, benefits program with no Government contribution.

This rule has been reviewed by the Office of Management and Budget in accordance with Executive Order 12866.

We have examined this rule in accordance with Executive Order 13132, Federalism, and have determined that this rule will not have any negative impact on the rights, roles and responsibilities of State, local, or tribal governments.

Accordingly, OPM is amending 5 CFR part 875 as follows:

This interim final rule is necessary because in Bernard v. Dep't of Agric., 788 F.3d 1365, 1367-70 (Fed. Cir. 2015), the United States Court of Appeals for the Federal Circuit held that the MSPB's regulations provide no clear guarantee that parties are authorized to undertake discovery in enforcement proceedings. This interim final rule amends the MSPB's regulations to address this holding and make clear that the parties have a right to discovery in such cases under the Board's existing discovery procedures.

A new provision, section 1201.183(a)(9), is inserted to make clear that discovery may be undertaken in enforcement matters. This new provision makes clear that the Board's regular discovery procedures apply in enforcement matters and sets a deadline by which initial discovery requests must be filed. As in other Board cases, this deadline may be changed by the judge.

Ordinarily, the Administrative Procedure Act (APA) requires an agency to provide notice of proposed rulemaking and a period of public comment before the promulgation of a new regulation. 5 U.S.C. 553(b) and (c). However, section 553(b) of the APA specifically provides that the notice and comment requirements do not apply:

(A) To interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice; or

(B) when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest. The APA also requires the publication of any substantive rule at least thirty days before its effective date, 5 U.S.C. 553(d), except where the rule is interpretive, where the rule grants an exception or relieves a restriction, or “as otherwise provided by the agency for good cause found and published with the rule.” Id.

The Board finds that use of an immediately effective interim final rule instead of notice and comment rulemaking is appropriate here because the amendments contained herein merely reflect the decision of the Federal Circuit in Bernard and are necessary to avert any further confusion regarding the Board's practice and procedures governing the right to discovery in compliance cases. Under these circumstances, notice and comment rulemaking is unnecessary and not required by any public interest.

Accordingly, for the reasons set forth in the preamble, the Board amends 5 CFR part 1201 as follows:

On October 11, 2006, Honda Aircraft Company applied for a type certificate for their new Model HA-420. On October 10, 2013, Honda Aircraft Company requested an extension with an effective application date of October 1, 2013. This extension changed the type certification basis to amendment 23-62.

The HA-420 is a four to five passenger (depending on configuration), two crew, lightweight business jet with a 43,000-foot service ceiling and a maximum takeoff weight of 9963 pounds. The airplane is powered by two GE-Honda Aero Engines (GHAE) HF-120 turbofan engines.

The HA-420 airplane will use a cruise speed control system (CSC), which is part of the automatic flight control system (AFCS), to reduce pilot workload during cruise flight only. The intended function is automatic airplane speed control during altitude hold AFCS mode by adjustment of the engine thrust within a narrow authority band utilizing the existing engine synchronization control. The CSC system does not back drive the throttles. The command authority is limited to values used for engine synchronization and can only be engaged when the throttle is positioned in a pre-determined range typically used for cruise power. This significantly reduces the CSC authority such that failure modes of the system should be minor. The proposed CSC system functions in a manner similar to an auto-throttle system, but has significantly less authority when compared to a traditional auto-throttle system.

Under the provisions of 14 CFR 21.17, Honda Aircraft Company must show that the HA-420 meets the applicable provisions of part 23, as amended by amendments 23-1 through 23-62, thereto.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 23) do not contain adequate or appropriate safety standards for the HA-420 because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, the HA-420 must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36. In addition, the FAA must issue a finding of regulatory adequacy pursuant to § 611 of Public Law 92-574, the “Noise Control Act of 1972.”

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type-certification basis under § 21.17(a)(2). Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.

The HA-420 will incorporate the following novel or unusual design features: Cruise Speed Control system

As defined in the summary section, this airplane makes use of a CSC system, which is a novel design for this type of airplane. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. Mandating additional requirements, developed in part by adapting relevant portions of 14 CFR 25.1329, Automatic pilot systems, applicable to auto-throttle systems along with FAA experience with similar autothrust systems, mitigates the concerns associated with installation of the proposed CSC system.

Notice of proposed special conditions No. 23-15-05-SC for the Honda Aircraft Company model HA-420 airplanes was published in the Federal Register on September 23, 2015 (80 FR 57312). No comments were received; therefore, the special conditions are adopted as proposed.

As discussed above, these special conditions are applicable to the HA-420. Should Honda Aircraft Company apply at a later date for a change to the type certificate to include another model on the same type certificate incorporating the same novel or unusual design feature, the special conditions would apply to that model as well.

Under standard practice, the effective date of final special conditions would be 30 days after the date of publication in the Federal Register; however, as the certification date for the Honda Aircraft Company model HA-420 airplane is imminent, the FAA finds that good cause exists to make these special conditions effective upon issuance.

This action affects only certain novel or unusual design features on one model of HA-420 airplane. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Honda Aircraft Company HA-420 airplanes.

1. Cruise Speed Control.

In addition to the requirements of §§ 23.143, Controllability and Maneuverability—General; 23.1309, Equipment, systems, and installations; and 23.1329, Automatic pilot system; auto throttle systems of limited authority that do not back drive the throttles and for which all failure modes are shown to be no greater than minor, the following requirements apply:

(a) Quick disengagement controls for the autothrust functions must be provided for each pilot. Quick disengagement controls must be readily accessible to each pilot while operating the thrust control levers.

(b) The effects of a failure of the system to disengage the autothrust functions when manually commanded by the pilot must be assessed in accordance with the requirements of § 23.1309.

(c) Engagement or switching of the flight guidance system, a mode, or a sensor may not cause the autothrust system to effect a transient response that alters the airplane's flight path any greater than a minor transient, as defined in paragraph (l)(1) of this section.

(d) Under normal conditions, the disengagement of any automatic control function of a flight guidance system may not cause a transient response of the airplane's flight path any greater than a minor transient.

(e) Under rare normal and non-normal conditions, disengagement of any automatic control function of a flight guidance system may not result in a transient any greater than a significant transient, as defined in paragraph (l)(2) of this section.

(f) The function and direction of motion of each command reference control (such as CSC) must be plainly indicated on, or adjacent to, each control, if necessary to prevent inappropriate use or confusion.

(g) Under any condition of flight appropriate to its use, the flight guidance system may not produce hazardous loads on the airplane, nor create hazardous deviations in the flight path. This applies to both fault-free operation and in the event of a malfunction, and assumes that the pilot begins corrective action within a reasonable period of time.

(h) When the flight guidance system is in use, a means must be provided to avoid excursions beyond an acceptable margin from the speed range of the normal flight envelope. If the airplane experiences an excursion outside this range, a means must be provided to prevent the flight guidance system from providing guidance or control to an unsafe speed.

(i) The flight guidance system functions, controls, indications, and alerts must be designed to minimize flightcrew errors and confusion concerning the behavior and operation of the flight guidance system. Means must be provided to indicate the current mode of operation, including any armed modes, transitions, and reversions. Selector switch position is not an acceptable means of indication. The controls and indications must be grouped and presented in a logical and consistent manner. The indications must be visible to each pilot under all expected lighting conditions.

(j) Following disengagement of the autothrust function, a caution (visual and, unless there are no misleading or hazardous consequences associated with its absence, auditory) must be provided to each pilot.

(k) During autothrust operation, it must be possible for the flightcrew to move the thrust levers without requiring excessive force. The autothrust may not create a potential hazard when the flightcrew applies an override force to the thrust levers.

(l) For purposes of this section, a transient is a disturbance in the control or flight path of the airplane that is not consistent with response to flightcrew inputs or environmental conditions.

(1) A minor transient would not significantly reduce safety margins and would involve flightcrew actions that are well within their capabilities. A minor transient may involve a slight increase in flightcrew workload or some physical discomfort to passengers or cabin crew.

(2) A significant transient may lead to a significant reduction in safety margins, an increase in flightcrew workload, discomfort to the flightcrew, or physical distress to the passengers or cabin crew, possibly including non-fatal injuries. Significant transients do not require, in order to remain within or recover to the normal flight envelope, any of the following:

(i) Exceptional piloting skill, alertness, or strength.

(ii) Forces applied by the pilot which are greater than those specified in § 23.143(c).

(iii) Accelerations or attitudes in the airplane that might result in further hazard to secured or non-secured occupants.

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to add an AD that would apply to all Fiberglas-Technik Rudolf Lindner GmbH & Co. KG Models G103 TWIN ASTIR, G103 TWIN II, and G103A TWIN II ACRO gliders. The NPRM was published in the Federal Register on August 10, 2015 (80 FR 47871). The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states:

The MCAI can be found in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-3300-0003.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the proposal and the FAA's response to each comment.

William Tisdale requested that the AD give credit for inspections that were done following Fiberglas-Technik Rudolf Lindner Service Bulletin (SB-G08), Edition April 24, 2015; and Fiberglas-Technik Rudolf Lindner Anweisung (English translation: Instructions), (A/I-G08), Ausgabe (English translation: Edition) April 24, 2015, within the year before the AD being issued as meeting the initial inspection requirement for both the tension and crack inspection.

We infer that the commenter made this request in order to prevent duplication of work already done.

We agree with the commenter. In paragraph (f) of this AD, the first sentence reads, “Unless already done, do the following actions:.” This sentence gives compliance credit to owners/operators of the affected gliders for actions required by this AD that have already been done before the effective date of this AD, if done following the service information required by this AD.

Because the requested change is already part of this AD, we have not changed the final rule AD action based on this comment.

William Tisdale requested the use of a lighted borescope from either the wing rib root or access through the spoiler box push rod opening to inspect the bell-crank.

We infer that the commenter wants us to incorporate into the AD an allowance to use a lighted borescope to do the inspection of the bell-crank installed in the air brake control system.

We agree with the commenter about using a lighted borescope for the inspection from the wing rib root as it is already allowed in Fiberglas-Technik Rudolf Lindner Service Bulletin (SB-G08), Edition April 24, 2015; and Fiberglas-Technik Rudolf Lindner Anweisung (English translation: Instructions), (A/I-G08), Ausgabe (English translation: Edition) April 24, 2015. In the service information it states, “This inspection is done using an endoscope or small camera working through the wing root rib or using a mirror when working through an inspecting opening.” An endoscope consists of an optical system with a high intensity light source and is sometimes referred to as a borescope.

We disagree with the commenter with using a lighted borescope to do the inspection by accessing the area through the spoiler box push rod opening since this procedure is not specified in the required service information. The commenter may request an alternative method of compliance (AMOC) for this process. The request, including all substantiating data, may be submitted following 14 CFR 39.19 as specified in paragraph (g)(1) of this AD.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (80 FR 47871, August 10, 2015) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 47871, August 10, 2015).

We reviewed Fiberglas-Technik Rudolf Lindner Service Bulletin (SB-G08), Edition April 24, 2015; and Fiberglas-Technik Rudolf Lindner Anweisung/(English translation: Instructions), (A/I-G08), Ausgabe (English translation: Edition) April 24, 2015. The service information describes procedures for inspecting the air brake locking forces; inspecting the bell-crank; and, if cracks are found during the inspections, replacing the bell-crank. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of the AD.

We consider this AD interim action. The design approval holder is working toward a terminating action for the repetitive inspections. We may take further AD action in the future.

We estimate that this AD will affect 106 products of U.S. registry. We also estimate that it will take about 2 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the cost of this AD on U.S. operators to be $18,020, or $170 per product.

In addition, we estimate that any necessary follow-on actions will be as follows:

• Replacement of bell-crank will take about 5 work-hours per product. Required parts will cost about $566 for a total of $991 per product.

• Installation of optional inspection openings will take about 15 work-hours per product. Required parts will cost about $1,004 for a total of $2,279 per product.

We have no way of determining the number of products that may need these actions.

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591. ATTN: Information Collection Clearance Officer, AES-200.

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

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

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

For the reasons discussed above, I certify this AD:

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

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-3300; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

Background

The Independent Offices Appropriations Act of 1952 (IOAA), which is codified at 31 U.S.C. 9701, authorizes agencies to prescribe regulations that establish user fees for services provided by the agency. The charges must be fair and must be based on the costs to the government, the value of the service to the recipient, the public policy or interest served, and other relevant facts. The IOAA provides that regulations implementing user fees are subject to policies prescribed by the President; these policies are set forth in the Office of Management and Budget Circular A-25, 58 FR 38142 (July 15, 1993) (OMB Circular A-25).

Under OMB Circular A-25, federal agencies that provide services that confer benefits on identifiable recipients are to establish user fees that recover the full cost of providing the special benefit. An agency that seeks to impose a user fee for government-provided services must calculate the full cost of providing those services. In general, a user fee should be set at an amount that allows the agency to recover the direct and indirect costs of providing the service, unless the Office of Management and Budget grants an exception. OMB Circular A-25 provides that agencies are to review user fees biennially and update them as necessary.

Section 6109(a)(4) of the Internal Revenue Code authorizes the Secretary to prescribe regulations for the inclusion of a tax return preparer's identifying number on a return, statement, or other document required to be filed with the IRS. On September 30, 2010, the Treasury Department and IRS published final regulations under section 6109 (REG-134235-08) in the Federal Register (TD 9501) (75 FR 60315) (PTIN regulations) to provide that, for returns or claims for refund filed after December 31, 2010, the identifying number of a tax return preparer is the individual's PTIN or such other number prescribed by the IRS in forms, instructions, or other appropriate guidance. The PTIN regulations require a tax return preparer who prepares or who assists in preparing all or substantially all of a tax return or claim for refund after December 31, 2010 to have a PTIN. The PTIN regulations also state that the IRS will set forth in forms, instructions or other appropriate guidance PTIN application and renewal procedures, including the payment of a user fee. The PTIN regulations further state that the IRS may conduct a Federal tax compliance check on an individual who applies for or renews a PTIN.

In accordance with section 1.6109-2(d) of the PTIN regulations, the IRS has set forth application and renewal procedures in Form W-12, IRS Paid Preparer Tax Identification Number (PTIN) Application and Renewal, and the Form W-12 Instructions. Individuals may also apply for or renew a PTIN and pay the user fee online at irs.gov/ptin. The annual PTIN application and renewal period generally begins in the fall (on October 15 in previous years) of the year preceding the filing season to which the PTIN relates. A third-party vendor processes applications to obtain or renew a PTIN and charges a reasonable fee that is separate from the user fee charged by the government.

Requiring the use of PTINs improves tax administration and tax compliance and benefits tax return preparers by allowing them to provide an identifying number on the return that is not an SSN. Requiring the use of PTINs enables the IRS to better collect and track data on tax return preparers, including the number of persons who prepare returns, the qualifications of those who prepare returns, and the number of returns each person prepares. PTIN use allows the IRS to more easily identify and communicate with tax return preparers who make errors on returns, which benefits tax return preparers by improving compliance and therefore reducing the number of client returns that are examined. The PTIN also enables the IRS to more easily locate and review returns prepared by a tax return preparer when instances of misconduct or potential misconduct are detected, which aids tax administration and compliance. These aids to tax administration and compliance in turn benefit taxpayers and tax return preparers by working to reduce preparer error and misconduct.

Section 1.6109-2(d) states that only individuals authorized to practice before the IRS under 31 U.S.C. 330 are eligible to obtain a PTIN. Under section 1.6109-2(h), the IRS may prescribe in forms, instructions, or other appropriate guidance exceptions to the requirements of the PTIN regulations, including the requirement that an individual must be authorized to practice before the IRS to be eligible to receive a PTIN. On December 30, 2010, the IRS released Notice 2011-6 (2011-3 IRB 315 (Jan. 17, 2011)), which stated that, until December 31, 2013, a provisional PTIN could be renewed upon proper application and payment of the applicable user fee, even if the individual holding the provisional PTIN was not authorized to practice before the IRS.

On June 3, 2011, the Treasury Department and the IRS published in the Federal Register (76 FR 32286) amendments to Treasury Department Circular No. 230 (31 CFR part 10), to regulate all tax return preparers under 31 U.S.C. 330. In Loving v. IRS, 917 F.Supp.2d 67 (D.D.C. 2013), the district court concluded that the IRS and Treasury Department lacked statutory authority to regulate tax return preparation as practice before the IRS under 31 U.S.C. 330 and enjoined the IRS and Treasury from enforcing the regulation of registered tax return preparers. The district court subsequently modified its order to clarify that the IRS's authority to require that tax return preparers obtain a PTIN is unaffected by the injunction. Loving v. IRS, 920 F.Supp.2d 108, 109 (D.D.C. 2013) (stating “Congress has specifically authorized the PTIN scheme by statute . . . [and that] scheme, therefore, does not fall within the scope of the injunction and may proceed as promulgated.”). The United States Court of Appeals for the District of Columbia Circuit affirmed the district court's decision and order for injunction. Loving v. IRS, 742 F.3d 1013 (D.C. Cir. 2014).

Final regulations (REG-139343-08) published in the Federal Register (TD 9503) (75 FR 60316) (PTIN user fee regulations) on September 30, 2010, established a $50 user fee to apply for or renew a PTIN. The $50 user fee was based on an annual PTIN renewal period and an estimate that 1.2 million individuals would be applying for or renewing a PTIN each year.

The IRS and Treasury Department determined that a $50 user fee to apply for or renew a PTIN would recover the full direct and indirect costs that the government incurs to administer the PTIN application and renewal process. The initial determination of a $50 annual fee took into account certain costs that the IRS ascertained it would incur to provide the special benefit associated with the provision of PTINs. As explained in the PTIN user fee regulations, the initial projected costs included the development and maintenance of the IRS information technology system that would interface with a third-party vendor, the development and maintenance of internal applications that would have the capacity to process and administer the anticipated increase in PTIN applications, customer service support activities, which included Web site development and maintenance and call center staffing to respond to questions regarding PTIN usage and renewal. The $50 user fee was also determined to recover costs for personnel, administrative, and management support needed to evaluate and address tax compliance issues of individuals applying for and renewing a PTIN, to investigate and address conduct and suitability issues, and otherwise support and enforce the programs that required an individual to apply for and renew a PTIN.

The vendor's fee, currently set at $14.25 for new applications and $13 for renewal applications, is paid directly to the vendor and covers the costs incurred by the vendor to process applications and renewals. The agency user fee and the vendor fee pay for different aspects of the PTIN program, each of which is essential to the program.

Pursuant to the guidelines in OMB Circular A-25, the IRS has re-calculated its cost of providing services under the PTIN application and renewal process. The IRS has determined that the full cost of administering the PTIN program going forward has been reduced from $50 to $33 per application or renewal. Individuals who prepare or assist in preparing all or substantially all of a tax return or claim for refund for compensation are required to have a PTIN. The ability to prepare tax returns and claims for refund for compensation is a special benefit, for which the IRS may charge a user fee to recover the full costs of providing the special benefit.

The amount of the user fee is $33 for both initial PTIN applications and renewals because the activities the IRS is required to perform to issue a new PTIN or renew an existing PTIN are the same. Pursuant to the authority granted in section 6109(c), the IRS has determined that it requires certain information to assign (or, in the case of a renewal, re-assign) a PTIN to an individual. The required information is set forth in the Form W-12 and Form W-12 Instructions.

The PTIN user fee is based on direct costs of the PTIN program, which include staffing and contract-related costs for activities, processes, and procedures related to the electronic and paper registration and renewal submissions; tax compliance and background checks; professional designation checks; foreign preparer processing; compliance and IRS complaint activities; information technology and contract-related expenses; and communications. The PTIN user fee also takes into account various indirect program costs, including management and support costs.

The reduction in the fee amount is attributable to several factors, which include the reduced number of PTIN holders (approximately 700,000) from the number originally projected (1.2 million) in 2010, which reduced associated costs; the absorption of certain development costs in the early years of the program; and the fact that certain activities that would have been required to regulate registered tax return preparers will not be performed. In particular, the determination of the user fee no longer includes expenses for personnel who perform functions primarily related to continuing education and testing for registered tax return preparers. Additionally, expenses related to personnel who perform continuing education and testing for enrolled agents and enrolled retirement plan agents were also removed from the user fee.

Individuals who apply for or renew a PTIN will continue to pay a fee directly to a third-party vendor, which is separate from the user fee described in this Treasury decision. The vendor fee is increasing from $14.25 for original applications and $13 for renewal applications to $17 for original applications and $17 for renewal applications.

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866, as supplemented by Executive Order 13563.

Historically, the annual PTIN application and renewal period has begun on October 15. For 2015, the date has been postponed to November 1. There is insufficient time before November 1 to provide an opportunity for notice and public comment and issue a final regulation prior to that date. To enable the reduced fee amount to be in effect for PTINs issued or renewed by tax return preparers preparing returns in 2016, the IRS and Treasury find that there is good cause to dispense with (1) notice and public comment pursuant to 5 U.S.C. 553(b) and (c) and (2) a delayed effective date pursuant to 5 U.S.C. 553(d). It would be impracticable, unnecessary, and contrary to the public interest to continue to charge the current fee when the IRS has determined pursuant to the biennial review conducted under OMB Circular A-25 that the fee should be reduced going forward. The IRS and Treasury Department will consider public comments submitted in response to the cross-referenced notice of proposed rulemaking published elsewhere in this issue of the Federal Register and will promulgate a final rule after considering those comments.

For applicability of the Regulatory Flexibility Act, please refer to the cross-referenced notice of proposed rulemaking published elsewhere in this issue of the Federal Register. Pursuant to section 7805(f), this Treasury decision has been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

The principal author of these regulations is Hollie M. Marx, Office of the Associate Chief Counsel (Procedure and Administration).

Accordingly, 26 CFR part 300 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), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

• Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

• Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR cite 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-2014-0607 in the subject line on the first page of your submission. All requests must be in writing, and must be received by the Hearing Clerk on or before December 29, 2015. 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-2014-0607, 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.

In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-9918-90), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP #4F8286) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.657 be amended by establishing a tolerance for the combined residues of the insecticide metaflumizone (2-[2-(4-cyanophenyl)-1-[3-(trifluoromethyl)phenyl]ethylidene]-N-[4-(trifluoromethoxy)phenyl] hydrazinecarboxamide; E and Z isomers) and its metabolite 4-{2-oxo-2-[3-(trifluoromethyl)phenyl]ethyl}-benzonitrile, in or on the raw agricultural commodities citrus (crop group 10-10) at 0.04 ppm; pome fruit (crop group 11-10) at 0.04 ppm; stone fruit (crop group 12-12) at 0.04 ppm; and tree nut (crop group 14-12) at 0.04 ppm. In addition, that petition requested removal of the existing tolerances for metaflumizone in or on fruit, citrus group 10 at 0.04 ppm and nut, tree, group 14 at 0.04 ppm upon establishment of the petitioned-for tolerances. That document included a summary of the petition prepared by BASF Corporation, the registrant. There were no substantive comments received in response to the notice of filing.

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

Consistent with FFDCA section 408(b)(2)(D), 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, consistent with FFDCA section 408(b)(2), for a tolerance for metaflumizone, including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

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

Hematotoxicity (toxicity of the blood) was the primary toxic effect of concern following subchronic or chronic oral exposures to metaflumizone. Splenic extramedullary hematopoiesis, increased hemosiderin, and anemia were the most common hematotoxic effects reported after repeated oral dosing with metaflumizone. Chronic oral (gavage) exposures to dogs resulted in slight decreases in mean corpuscular hemoglobin concentration and total hemoglobin, leading to increased plasma bilirubin, increased urinary urobilinogen, and increased hemosiderin in the liver. In a chronic toxicity/carcinogenicity study in mice, anemia was observed in the form of increased hemosiderin in the spleen, increased mean absolute reticulocyte count, decreased mean corpuscular volume, and mean corpuscular hemoglobin.

The postulated pesticidal mode of action of metaflumizone involves inhibition of sodium channels in target insect species; however, in mammals (rats), there were only clinical signs of neurotoxicity (i.e., piloerection and body temperature variations) with no neuropathology in the presence of systemic toxicity (e.g., recumbency and poor general state) following acute or repeated exposures. Similarly, several immune system organs seem to be affected following metaflumizone administration via the oral, dermal, and inhalation routes (e.g., the presence of macrophages in the thymus, lymphocyte necrosis in the mesenteric lymph nodes, and diffuse atrophy of the mandibular); however, there was no evidence of any functional deficits at the highest dose tested in a recently submitted and reviewed guideline immunotoxicity study. Therefore, the clinical neurotoxicity signs and the effects on the immune system organs following metaflumizone administration are likely to be secondary to the hematotoxic effects.

Metaflumizone induced an increased incidence of a missing subclavian artery at a relatively high dose that also caused severe maternal toxicity (e.g., late term abortions) in the developmental toxicity study in rabbits. There was no evidence (quantitative or qualitative) of increased susceptibility following in utero exposures to rats or rabbit and following pre- and post natal exposures. There was no evidence that metaflumizone is genotoxic and carcinogenicity studies with mice and rabbits were negative.

Specific information on the studies received and the nature of the adverse effects caused by metaflumizone as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document entitled, “Metaflumizone: Human Health Risk Assessment in Support of Section 3 Registrations for Application of Metaflumizone to Pome Fruit (crop group (CG) 11-10) and Stone Fruit (CG 12-12); Updating the CG Designation for Citrus to 10-10 and Tree Nuts to 14-12; and Permitting Aerial Application to Citrus Fruits, Grapes, Tree Nuts, and Nurseries Containing Field-/Container-Grown Nonbearing Stone and Pome Fruit Trees” in docket ID number EPA-HQ-OPP-2014-0607.

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

A summary of the toxicological endpoints for metaflumizone used for human risk assessment is provided below:

i. Acute Dietary Endpoint (General population including infants and children). An acute dietary endpoint was not established for this population group since an endpoint of concern (effect) attributable to a single dose was not identified in the database. Studies considered for this endpoint included the acute neurotoxicity study for which a LOAEL was not observed.

ii. Acute Dietary Endpoint (Females 13-49 years old). This endpoint was established based on a developmental effect observed in the rabbit developmental toxicity study that can be potentially due to a single dose of metaflumizone. This effect consisted of an increased incidence of an absent subclavian artery in the offspring at the LOAEL of 300 milligram/kilogram (mg/kg) body weight/day (bw/day) metaflumizone (NOAEL = 100 mg/kg bw/day). The rat developmental toxicity study was also considered for this endpoint; however, no developmental effects were observed in this study at the highest dose tested of 120 mg/kg bw/day metaflumizone. A combined uncertainty factor (UF) of 300 was applied to account for interspecies (10x) and intraspecies (10x) extrapolation. A Food Quality Protection Act (FQPA) safety factor (SF) of 3x was retained because the rabbit developmental toxicity study was performed via oral gavage dosing. In an absorption study submitted by the petitioner, dietary exposures (which are more relevant for human exposures) exhibited an approximately 2-fold greater absorption into the systemic circulation than oral gavage dosing and, thus, can potentially lead to toxicity at 2-fold lower levels of exposure. Thus, aPAD for females 13-49 years old is estimated to be 0.33 mg/kg bw/day.

iii. Chronic Dietary Endpoint. This endpoint was established based on results of a chronic toxicity study with dogs via capsule administration. The effects at the LOAEL of 30 mg/kg bw/day (NOAEL = 12 mg/kg bw/day), consisted of reduced general health condition, slight to severe ataxia, recumbency, and severe salivation, decreases in mean cell hemoglobin concentration (MCHC) and total hemoglobin (Hb) and increased bilirubin, increased urobilinogen, and increased hemosiderin in the liver. A combined UF of 300 was applied to account for interspecies (10x) and intraspecies (10x) extrapolation and an FQPA SF of 3x was retained for the higher absorption observed in dietary exposures to metaflumizone (see above). Thus, the chronic population adjusted dose (cPAD) is estimated to be 0.040 mg/kg bw/day.

iv. Incidental Oral (Short- and Intermediate-Term). This endpoint was selected on the basis of the maternal effects observed in the rat two-generation reproductive toxicity study at the LOAEL of 50 mg/kg bw/day metaflumizone (NOAEL = 20 mg/kg bw/day). Maternal toxicity consisted of poor general health and body weight deficits which were also associated with improper nursing behavior. Similar effects were also noted in a developmental neurotoxicity study (gavage, range finding) also considered for this endpoint. In this study, poor maternal health was also observed at the LOAEL of 120 mg/kg bw/day metaflumizone (NOAEL = 80 mg/kg bw/day). Both studies considered for this endpoint achieved a clear maternal NOAEL for the offspring effects, but the NOAEL of 20 mg/kg bw/day for the 2-generation reproductive toxicity study is considered more protective. A combined UF of 300 was applied to account for interspecies (10x) and intraspecies (10x) extrapolation, and an FQPA SF of 3x to account for the 2-fold greater absorption observed in dietary versus oral gavage exposures (see above). The LOC is 300.

v. Dermal (Short- and Intermediate-Term). This endpoint was based on a rat 90-day dermal toxicity study in which deficits in body weight, body-weight gain, and food consumption (in males and females); anogenital smearing; increased macrophages in the thymus; lymphocyte necrosis in the mesenteric lymph nodes; diffuse atrophy of the mandibular lymph node; and increased hemosiderin in the liver (females only) were observed at the LOAEL of 300 mg/kg bw/day (NOAEL = 100 mg/kg bw/day). The LOC, for both occupational and residential exposure is 100, based on a combined UF of 100 for interspecies (10x) and in intraspecies (10x) extrapolation. The FQPA SF is reduced to 1x for this exposure scenario because there is no residual uncertainty concerning potential effects on infants and children.

vi. Inhalation (Short- and Intermediate-Term). There is a 28-day inhalation study that is adequate for both exposure durations. There was no NOAEL identified for female rats. At the LOAEL of 0.10 milligrams per Liter (mg/L) metaflumizone (NOAEL = 0.03 mg/L), histopathology of the nasal tissues, lungs, thymus, prostate, and adrenal cortex was observed in males. The LOAEL of 0.03 mg/L identified in females resulted in lymphocyte necrosis in the mesenteric lymph node.

The methods and dosimetry equations described in EPA's reference concentration (RfC) guidance (1994) are suited for calculating human-equivalent concentrations (HECs) based on the inhalation toxicity point of departure (NOAEL, LOAEL, or Benchmark Dose Lower Confidence Limit (BMDL)) for use in MOE calculations. The regional-deposited-dose ratio (RDDR), which accounts for the particulate diameter (mass median aerodynamic diameter (MMAD) and geometric standard deviation (σg) of aerosols), can be used to estimate the different dose fractions deposited along the respiratory tract. The RDDR accounts for interspecies differences in ventilation and respiratory-tract surface areas. Thus, the RDDR can be used to adjust an observed inhalation particulate exposure of an animal to the predicted inhalation exposure for a human. For the subchronic inhalation toxicity study with metaflumizone, an RDDR was estimated at 2.81 based on systemic effects (lymphocyte necrosis in the mesenteric lymph node) in females at the LOAEL of 0.03 mg/L (no NOAEL established), and a MMAD of 1.7 micrometer (μm) and σg of 2.7.

For this action with metaflumizone, residential and occupational handler scenarios are being assessed. For residential handler scenarios, 2-hr/day inhalation exposures are assumed. Adjustment to shorter exposure scenarios relative to the animal toxicity study duration (e.g., 2 hr. residential exposures) should only be made if there is time-course information that would support a shorter time-frame. Since there is no such information available for metaflumizone, the unadjusted animal POD was used to assess the shorter duration residential handler exposures. Thus, the HEC equals the LOAEL from the study, and was calculated to be 0.084 mg/L. The FQPA SF of 10x is being retained for lack of a NOAEL for females in the study. The standard interspecies extrapolation UF can be reduced from 10x to 3x due to the HEC calculation accounting for pharmacokinetic (not pharmacodynamic) interspecies differences. The intraspecies UF remains at 10x. Therefore, the LOC for this scenario is 300, which includes the FQPA SF of 10x, interspecies (3x), and intraspecies (10x) extrapolation.

1. Dietary Exposure from Food and Feed Uses. Tolerances have been established in (40 CFR 180.657) for the residues of metaflumizone, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from metaflumizone in food as follows:

i. Acute Exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for metaflumizone. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. As to residue levels in food, EPA assumed tolerance-level residues. It was further assumed that 100% of crops with the requested uses of metaflumizone were treated.

ii. Chronic Exposure. In conducting the chronic dietary exposure assessment, EPA used the food consumption data from the USDA NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance-level residues. It was further assumed that 100% of crops with the requested uses of metaflumizone were treated.

iii. Cancer. EPA has concluded that metaflumizone 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. EPA did not use anticipated residue or PCT information in the dietary assessment for metaflumizone. Tolerance-level residues and 100 PCT were assumed for all food commodities.

2. Dietary Exposure from Drinking Water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for metaflumizone in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of metaflumizone. 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 metaflumizone for acute exposures are estimated to be 1.03 parts per billion (ppb) for surface water and 1.09 x 10− 12 ppb for ground water. The EDWCs of metaflumizone for chronic exposures for non-cancer chronic assessments are estimated to be 0.487 ppb for surface water and 1.09 x 10− 12 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 1.03 ppb was used to assess the contribution of drinking water. For chronic dietary risk assessment, the water concentration value of 0.487 ppb was used to assess the contribution of 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). Metaflumizone is currently registered for the following uses that could result in residential exposures: As a fire ant bait for application to lawns, landscapes, golf courses, and other non-cropland area; and as a fly bait for use around industrial buildings, commercial facilities, agricultural structures/premises, and recreational facilities/areas.

EPA assessed residential exposure using the following assumptions: Fire ant bait applications to home lawns are expected to result in short-term, residential handler exposure to adults. Fire ant bait applications to lawns and golf-courses are expected to result in short-term, post-application dermal exposure to adults, children 11 to <16 years old, and children 1 to <2 years old, and incident oral exposure for children 1 to <2 years old. For the fly bait product, residential handler exposure is not expected, because the product is applied by commercial handlers. The fly bait product is expected to result in short-term, post-application dermal exposure to adults, children 11 to <16 years old, and children 1 to <2 years old, and incident oral exposure for children 1 to <2 years old.

For residential handlers, dermal and inhalation exposures are combined since the endpoints are similar for these routes. For children (1- to <2-year-olds), post-application hand-to-mouth and dermal exposures are combined. Since the LOCs for the dermal, inhalation and incidental oral routes are not the same (dermal LOC = 100, inhalation LOC = 300, and incidental oral LOC = 300), these routes were combined using the aggregate risk index approach. 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.”

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to metaflumizone and any other substances and metaflumizone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action; therefore, EPA has not assumed that metaflumizone has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's Web site at http://www.epa.gov/pesticides/cumulative.

1. In general. Section 408 of FFDCA provides that EPA shall apply an additional ten-fold 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 on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA SFs, as appropriate.

2. Prenatal and Postnatal Sensitivity. There is no evidence for increased qualitative or quantitative sensitivity/susceptibility resulting from pre- and/or postnatal exposures. In the rat prenatal development toxicity study, there was no offspring toxicity reported at any dose tested whereas in the rabbit study a maltransformation based on an absent subclavian artery was noted to occur only in the presence of severe maternal toxicity. Similarly, offspring mortality in the 2-generation reproductive toxicity occurred only in the presence of a poor maternal health state. Thus, there is no evidence for increased susceptibility.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced from 10x to 3x for all oral exposure scenarios; retained at 10x for inhalation exposure scenarios; and reduced to 1x for dermal exposures. That decision is based on the following findings:

i. The toxicological database for metaflumizone is adequate for risk assessment and FQPA SF evaluation. Several studies are available for evaluating the safety of metaflumizone, although differences in dose administration and a missing NOAEL warrant retention of various FQPA safety factors in this instance.

Dietary exposures exhibited an approximately 2-fold greater absorption into the systemic circulation as compared to oral gavage and, thus, can potentially lead to toxicity at 2-fold lower levels of exposure. Applying an FQPA SF of 3x for all oral exposure scenarios is adequate to protect against any greater toxicity that might occur in dietary exposures (absorption was noted to be 2-fold greater in dietary versus oral gavage studies).

The FQPA SF of 10x is being retained for inhalation exposure scenarios for the use of a LOAEL instead of a NOAEL (no NOAEL achieved) for histopathological lesions consisting of lymphocyte necrosis in the mesenteric lymph node. The FQPA SF of 10x is adequate because the effect (lymphocyte necrosis) is considered minimal to slight and does not exhibit a strong dose dependence.

The FQPA SF for dermal exposure scenarios is being reduced from 10x to 1x since there is a route-specific study with a clear NOAEL.

ii. There is no indication that metaflumizone directly affects the nervous system. Clinical signs indicative of neurotoxicity were observed in several studies; however, these signs were generally observed in the presence of poor animal health (e.g., reduced general health condition, loss of body weight, or death). In addition, no neuropathology was observed in any study with metaflumizone. There is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity.

iii. There are no residual concerns or uncertainties for increased sensitivity/susceptibility in developing animals resulting from pre- and/or postnatal exposure.

iv. There are no residual uncertainties identified in the exposure databases.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and 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. Based on the proposed/registered uses and since inhalation, dermal, and incidental oral exposures can be combined, aggregate acute (dietary), short-term (dietary, incidental oral, and/or dermal), and chronic (dietary) assessments were conducted.

1. Acute Risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute aggregate exposure assessment consists of exposure from only food and water. The acute dietary exposure assessment for females 13-49 years old was 1.6% of the aPAD and therefore, does not exceed EPA's LOC.

2. Chronic Risk. Since there are no registered/proposed uses that result in chronic residential exposure, the chronic aggregate exposure assessment consists of exposure from only food and water. The chronic dietary exposure estimate was ≤7.2% the cPAD and therefore, does not exceed EPA's LOC.

3. Short-Term Risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Metaflumizone is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to metaflumizone. Since the LOC and toxicological points of departure for the short-term dermal and oral routes of exposure differ, the aggregate risk index method was used to determine aggregate risk (aggregate risk indices >1 are not a risk of concern).

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate risk indices of 42 for the general population, and 22 for children 1-2 years old. Because EPA's LOC for metaflumizone is an aggregate risk index less than 1, the aggregate risks are not of concern.

4. Intermediate-Term Risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Metaflumizone is not currently registered for uses that could result in intermediate-term residential exposure; however, since the PODs for the short- and intermediate-term durations are the same for metaflumizone, the short-term aggregate assessment is protective of intermediate-term exposures.

5. Aggregate Cancer Risk for U.S. Population. As discussed in Unit III.A., EPA does not expect metaflumizone 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, and to infants and children from aggregate exposure to metaflumizone residues.

EPA previously reviewed method validation and independent laboratory validation (ILV) studies for the BASF high-performance liquid chromatography (HPLC)/mass spectrometry (MS)/MS analytical method 531/0 and forwarded the method to FDA for tolerance enforcement (46264221.der; D308394, T. Bloem, 30-Nov-2005; D328915, T. Bloem, 17-May-2006). It is noted that following method validation, BASF incorporated several minor modifications to method 531/0 with this revised method specified as 531/1 (method 531/1 is the current enforcement method). Based on the similarities of the proposed crops to that currently registered and since the grape, citrus, and tree nut residue samples were analyzed using a method very similar to the current enforcement method and since adequate validation data were submitted, EPA concludes that the current enforcement method is suitable for enforcement of the tolerances recommended herein. The limit of quantitation (LOQ) is 0.01 ppm for metaflumizone (E and Z isomers) and 0.018 ppm for M320I04 (expressed in parent equivalents).

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.

Codex MRLs are not established in/on the relevant crops for metaflumizone; therefore, harmonization is not an issue for this petition.

Therefore, the tolerance is established for the combined residues of the insecticide metaflumizone (2-[2-(4-cyanophenyl)-1-[3-(trifluoromethyl)phenyl]ethylidene]-N-[4-(trifluoromethoxy)phenyl] hydrazinecarboxamide; E and Z isomers), in or on the following raw agricultural commodities: Fruit, citrus, group 10-10 at 0.04 ppm; fruit, pome, group 11-10 at 0.04 ppm; fruit, stone, group 12-12 at 0.04 ppm; and nut, tree, group 14-12 at 0.04 ppm. The existing tolerances for fruit, citrus, group 10 at 0.04 ppm and for nut, tree, group 14 at 0.04 ppm are removed because they are superseded by the tolerances being established in this action.

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

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 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 Office of Chemical Safety and Pollution Prevention (OCSPP) test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

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-2013-0035 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 29, 2015. 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-2013-0035, 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 athttp://www.epa.gov/dockets.

In the Federal Register of July 19, 2013 (78 FR 43115) (FRL-9392-9), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2F8131) by E.I. du Pont de Nemours and Company, 1007 Market Street, Wilmington, DE 19898. The petition requested that 40 CFR 180.478 be amended by establishing tolerances for residues of the herbicide rimsulfuron, N-((4,6-dimethoxypyrimidin-2-yl)aminocarbonyl)-3-(ethylsulfonyl)-2-pyridinesulfonamide, in or on sorghum, forage; sorghum, grain; and sorghum, stover at 0.01 parts per million (ppm). That document referenced a summary of the petition prepared by E.I. du Pont de Nemours and Company, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has revised the proposed commodity definitions. EPA has also revised the chemical name nomenclature for rimsulfuron in the tolerance expression. The reasons for these changes are explained in Unit IV.C.

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

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

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

Rimsulfuron has low acute toxicity by oral, dermal, and inhalation routes of exposure. It is moderately irritating to the eye, non-irritating to the skin, and is not a skin sensitizer. In subchronic and chronic toxicity studies in rats, toxic effects included decreased body weight, decreased body weight gain, increased relative liver and absolute kidney weights, and diuresis. In the subchronic study in mice, increased red blood cell and hemoglobin, and decreased body weight gain and food efficiency were observed. In the chronic study in mice, decreased body weight, increased incidences of dilation and cysts in the glandular stomach, and degeneration of the testicular artery and tunica albuginea were observed. In the subchronic study in dogs, diuresis was indicated by urinary volume, platelet concentration, and kidney weights accompanied by decreased urinary osmolality. In the chronic study in dogs, increased absolute liver and kidney weights, increased seminiferous tubule degeneration, and increased number of spermatid giant cells present in epididymides in males were observed. In both sexes, decreases in mean body weights and body weight gain, and increases in serum cholesterol levels, alkaline phosphatase activity, absolute liver weight, relative liver, and relative kidney weights were observed.

In the developmental toxicity study in rats, no toxicity was seen at the highest dose tested. In the developmental toxicity study in rabbits (in which both maternal and fetal death were observed), and in the 2-generation reproduction toxicity study in rats (in which decreases in body weight gain were observed in both parents and offspring), developmental and offspring effects were seen in the presence of maternal/systemic toxicity at the same dose levels.

In the acute and subchronic neurotoxicity studies, no evidence of neurotoxicity was observed. In the immunotoxicity study, no evidence of immunosuppression was observed. In the mutagenicity studies, no evidence of clastogenicity or mutagenicity was observed. Rimsulfuron is classified as “Not Likely to be Carcinogenic to Humans” based on lack of evidence of carcinogenicity in rats and mice studies.

Specific information on the studies received and the nature of the adverse effects caused by rimsulfuron as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Rimsulfuron. Human Health Risk Assessment for Proposed Section 3 Use on Acetolactase Synthase (ALS) Tolerant Grain Sorghum” at pp. 27-32 in docket ID number EPA-HQ-OPP-2013-0035.

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

A summary of the toxicological endpoints for rimsulfuron used for human risk assessment is shown in Table 1 of this unit.

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0600 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 29, 2015. 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-2014-0600, 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 January 28, 2015 (80 FR 4525) (FRL-9921-55), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4E8230) by BASF Corporation, 26 Davis Dr., Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide teflubenzuron, in or on apple at 0.5 parts per million (ppm); apple, wet pomace at 0.8 ppm; broccoli at 0.2 ppm; cattle, meat byproducts at 0.01 ppm; cattle, muscle at 0.01 ppm; cauliflower at 0.01 ppm; citrus, oil at 90 ppm; coffee, bean, green at 0.6 ppm; corn, field, grain at 0.01 ppm; corn, field, refined oil at 0.02 ppm; egg at 0.01 ppm; goat, meat byproducts at 0.01 ppm; goat, muscle at 0.01 ppm; horse, meat byproducts at 0.01 ppm; horse, muscle at 0.01 ppm; lemon at 0.9 ppm; mango at 1.5 ppm; melon, at 0.3 ppm; milk at 0.01 ppm; orange at 0.6 ppm; papaya at 0.4 ppm; pineapple at 0.8 ppm; pork, muscle at 0.01 ppm; pork, meat byproducts at 0.01 ppm; poultry, meat byproducts at 0.01 ppm; poultry, muscle at 0.01 ppm; sheep, meat byproducts at 0.01 ppm; sheep, muscle at 0.01 ppm; soybean, hulls at 0.4 ppm; soybean, seed at 0.05 ppm; sugarcane, cane at 0.01 ppm; sunflower, seed at 0.3 ppm; tomato at 1.5 ppm; and tomato, paste at 5 ppm. That document referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket, http://www.regulations.gov. No tolerance-related comments were submitted. Based upon review of the data supporting the petition, EPA has edited tolerance levels for some food commodities, and declined to grant tolerances for others. The reasons for these changes are explained in Unit IV.C.

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

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

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Exposure of animals to teflubenzuron has shown no evidence of neurotoxicity, immunotoxicity, or genotoxicity. It is categorized as having low acute lethality by oral, dermal and inhalation routes of exposure. It is not a dermal sensitizer or eye irritant. In all species tested, hepatotoxicity was indicated. The liver is the primary target organ for teflubenzuron. In the mouse, which is the most sensitive species compared to the rat and the dog, liver adenomas were observed following chronic exposure. Increased enzyme release and numerous microscopic indicators of liver injury (diffuse hypertrophy, disseminated single-cell necrosis, patchy glycogen storage, Kupffer cell proliferation, phagocytic foci, lipofuscin accumulation and centrilobular fatty change) were observed in all species exposed to teflubenzuron.

The 2-generation reproductive study shows evidence of increased quantitative offspring susceptibility. There were no effects of teflubenzuron exposure on the parental generation, but effects on offspring consisted of decreased F2 litter weights and increased incidence of unilateral dilatation of the renal pelvis in F1 offspring. There is no evidence of increased fetal susceptibility in either the rat or rabbit developmental studies.

Because rare liver tumors were observed only in male mice and there was no evidence of carcinogenicity from teflubenzuron in female mice or in male or female rats, the Agency is using a non-linear approach (i.e. reference dose (RfD)) to account for the observed carcinogenicity that could result from exposure to teflubenzuron. Moreover, there is no concern for mutagenicity.

Specific information on the studies received and the nature of the adverse effects caused by teflubenzuron as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, “Teflubenzuron: Human Health Risk Assessment” at pp. 4, 13, 21, and 22 in docket ID number EPA-HQ-OPP-2014-0600.

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

A summary of the toxicological endpoints for teflubenzuron used for human risk assessment is shown in Table 1 of this unit.

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

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

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed teflubenzuron residues are present in all commodities at tolerance levels and that 100% of all crops are treated.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a non-linear RfD approach is appropriate for assessing cancer risk to teflubenzuron. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii. chronic exposure.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for teflubenzuron. Tolerance-level residues and/or 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. Because there are no domestic agricultural or residential uses registered or proposed for teflubenzuron, there will be no exposure in drinking water; therefore, a drinking water assessment is not necessary.

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).

Teflubenzuron is not registered for any specific use patterns that would result in residential exposure.

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 teflubenzuron to share a common mechanism of toxicity with any other substances, and teflubenzuron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that teflubenzuron 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 athttp://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 Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. The rat 2-generation reproductive study showed evidence of increased quantitative offspring susceptibility to teflubenzuron. While there were no parental effects, adverse offspring effects were observed and consisted of decreased F2 litter weights and increased incidence of unilateral dilatation of the renal pelvis in F1 offspring. There were no effects of teflubenzuron in the developmental rat study up to the highest dose tested. In the developmental rabbit study, maternal effects were observed at the limit dose and were consistent with liver toxicity; no fetal effects were observed.

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

i. The toxicity database for teflubenzuron is complete for assessing the safety of tolerances for which there is no associated U.S. pesticide registration.

ii. There is no indication that teflubenzuron is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.

iii. As discussed in Unit III.D.2., there is evidence of quantitative susceptibility in the rat in the 2-generation reproductive study. There is no residual concern or uncertainty regarding these effects as the study established a clear NOAEL and LOAEL. Moreover, the Agency is using a lower POD in its assessment, which will be protective of these effects.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. There are no drinking water or residential exposures as there are no U.S. registrations of pesticides containing teflubenzuron. These assessments will not underestimate the exposure and risks posed by teflubenzuron.

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

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, teflubenzuron is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to teflubenzuron from food and water will utilize 50% of the cPAD for children 1-2 years old the population group receiving the greatest exposure. There are no residential uses for teflubenzuron.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Teflubenzuron is for use on imported commodities only, no residential exposure or chronic exposure from water is expected. Because no short-term adverse effect was identified, teflubenzuron is not expected to pose a short-term risk.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because no intermediate-term adverse effect was identified, teflubenzuron is not expected to pose an intermediate-term risk.

5. Aggregate cancer risk for U.S. population. Based on the results of the chronic assessment, EPA concludes that teflubenzuron will not pose a cancer risk for the U.S. population.

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 teflubenzuron residues.

The petitioner submitted a high-performance liquid chromatography method with tandem mass-spectrometry detection (LC/MS/MS) analytical method, BASF Method L0160/01, for analysis of residues of teflubenzuronin/on dry and oily crop commodities. The method has been adequately validated by the petitioner as well as by an independent laboratory, and was also adequately radio validated using weathered samples obtained from metabolism studies. In addition, the Quechers multi residue method (MRM) is considered suitable for the analysis of teflubenzuron in fruits and vegetables.

Adequate enforcement methodology (high-performance liquid chromatography with tandem mass spectrometry) is available to enforce the tolerance expression.

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 established a MRL for teflubenzuron in or on pome fruit at 1.0 ppm. The U.S. tolerance being established for residues of teflubenzuron on apples is harmonized with this value.

The petition requested tolerances for several livestock commodities (cattle, meat byproducts; cattle, muscle; egg; goat, meat byproducts; goat, muscle; horse, meat byproducts; horse, muscle; milk; pork, meat byproducts; pork, muscle; poultry, meat byproducts; poultry, muscle; sheep, meat byproducts; and sheep, muscle.) Based on the results of livestock feeding studies, EPA is not establishing tolerances for these commodities because there is no expectation of finite residues in livestock commodities. The tolerance proposal for apple, wet pomace is not being established because the commodity is not likely to be imported. The petitioned-for tolerance for tomato, paste is not being established because concentration of residues is not expected above the tolerance established for tomato (1.5 ppm); the tolerance for tomato will be adequate to cover any residues in tomato paste.

In the case of apple, EPA is establishing a higher tolerance (from 0.5 ppm to 1.0 ppm) to harmonize with the established Codex MRL. Based on EPA's methods for calculating residue levels on processed commodities, EPA is establishing a higher tolerance for citrus, oil (90 ppm to 100 ppm) and a lower tolerance for soybean, hulls (0.4 ppm to 0.15 ppm) than what was requested. Using the Organization for Economic Cooperation and Development (OECD) calculation procedures, EPA is establishing a higher tolerance for papaya tolerance (0.4 ppm to 0.5 ppm) and a lower tolerance for the lemon (0.90 ppm to 0.80 ppm) than was requested.

In addition, EPA is adding significant figures to tolerance levels in accordance with EPA policy for the following commodities: Broccoli; coffee, bean, green; melon, subgroup 9A; orange; pineapple; and sunflower, seed. EPA is also revising the commodity term “corn, field” to “corn, field, grain” to be consistent with the food and feed commodity vocabulary used for tolerances. Finally, EPA is establishing a tolerance for “melon, subgroup 9A” instead of “melon” as requested because the regulatory definition of “melon” includes all commodities listed under “melon, subgroup 9A.”

Therefore, tolerances are established for residues of teflubenzuron, in or on apple at 1.0 ppm; broccoli at 0.20 ppm; cauliflower at 0.01 ppm; citrus, oil at 100 ppm; coffee, bean, green at 0.60 ppm; corn, field, grain at 0.01 ppm; corn, field, refined oil at 0.02 ppm; lemon at 0.80 ppm; mango at 1.5 ppm; melon, subgroup 9A at 0.30 ppm; orange at 0.60 ppm; papaya at 0.50 ppm; pineapple at 0.80 ppm; soybean, seed at 0.05 ppm; soybean, hulls at 0.15 ppm; sugarcane, cane at 0.01 ppm; sunflower, seed at 0.30 ppm; and tomato at 1.5 ppm.

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

The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the Federal Register.

In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

Accordingly, 44 CFR part 64 is amended as follows:

A battery-powered portable electronic smoking device (e-cigarette), also called an e-cig, a personal vaporizer or electronic nicotine delivery system, is a battery-powered device that simulates tobacco smoking. E-cigarettes contain a liquid, an atomizer or heating element, and a battery. When an e-cigarette is operated by a user, the heating element vaporizes the liquid. Many e-cigarettes are designed to look like traditional cigarettes, but they are also made to look like cigars, pipes, and even everyday products such as pens. The use of e-cigarettes has been rising substantially and e-cigarettes have increasingly become a common item in passenger baggage. Airline passengers and crewmembers are currently permitted to carry these devices under the provisions for portable electronic devices contained in 49 CFR 175.10(a)(18). However, the provisions for portable electronic devices do not adequately address the safety risks posed by e-cigarettes, which include a heating element as a function of their design.

Recent fire incidents involving e-cigarettes in checked baggage, along with actions taken by the Federal Aviation Administration (FAA) and ICAO, highlight the need for PHMSA to take prompt action to address this issue.

On August 9, 2014, at Boston's Logan Airport, an e-cigarette contained in a passenger's checked bag in the cargo hold of a passenger aircraft caused a fire that forced an evacuation of the aircraft. An airline ramp agent noticed smoke coming from the bag. The bag was removed from the aircraft cargo compartment and investigators determined the source of the fire was an e-cigarette, which continued to burn after it was removed from the bag. Air carrier personnel extinguished the fire. Massport Fire responded and ensured the fire was no longer burning. The fire burned a hole approximately 4 inches in diameter in the outer pocket of the bag. Passengers were deplaned as a precaution.

On January 4, 2015, at Los Angeles International Airport, a checked bag that arrived late and missed its connecting flight was found to be on fire in a baggage area. Emergency responders attributed the fire to an overheated e-cigarette inside the bag.

These incidents have shown that e-cigarettes can overheat and cause fires when the heating element is accidentally activated or turned on. This danger may be exacerbated by the growing trend of users modifying and rebuilding their reusable e-cigarette devices and swapping components, which may include the use of batteries, heating elements, and electronic components not original to the manufactured e-cigarette.

An October 2014 report from the U.S. Fire Administration 1 identified at least 25 incidents of explosion and fire involving e-cigarettes between 2009 and 2014. Many of these incidents occurred while the device was charging and resulted in the ignition of nearby combustible materials. This report highlights the risks associated with charging e-cigarettes.

Following the fire at Logan Airport, on December 10, 2014, the ICAO issued an Electronic Bulletin (EB) titled, Dangerous Goods Carried by Passenger and Crew—Incidents Related to Electronic Cigarettes (EB 2014/074).2 The ICAO bulletin recommended that a passenger's e-cigarettes be carried in the cabin of the aircraft and not in checked baggage.

On January 22, 2015, the FAA issued a Safety Alert for Operators (SAFO) 3 that highlighted current provisions of the hazardous materials regulations (HMR), which state, “transportation of battery-powered devices that are likely to create sparks or generate a dangerous evolution of heat is prohibited unless they are packaged in such a manner to preclude such an occurrence (see 49 CFR 173.21(c)).” The SAFO further recommended that air operators require their passengers to carry e-cigarettes only in the cabin of the aircraft.

Effective June 9, 2015, the ICAO published an addendum to the 2015-2016 ICAO Technical Instructions for the Safe Transport of Dangerous Goods by Air to prohibit carriage of e-cigarettes in checked baggage and restrict the charging of these devices while on board the aircraft. This addendum constitutes an amendment to the 2015-2016 ICAO Technical Instructions, which took effect on January 1, 2015. On January 8, 2015, PHMSA published a rulemaking harmonizing the HMR with the 2015-2016 ICAO Technical Instructions. This issuance of this interim final rule is necessary to incorporate the June 9, 2015 amendment to the Technical Instructions to address the known safety risk.

The partial restriction in this interim final rule applies only to battery-powered portable electronic smoking devices (e.g., e-cigarettes, e-cigs, e-cigars, e-pipes, e-hookahs, personal vaporizers, electronic nicotine delivery systems). Passengers and crewmembers can continue to carry battery-powered portable electronic smoking devices in carry-on baggage. This interim final rule does not prohibit a passenger from transporting other devices containing batteries for personal use (such as laptop computers, cell phones, cameras, etc.) in checked or carry-on baggage nor does it restrict a passenger from transporting batteries for personal use in carry-on baggage.

PHMSA is issuing this interim final rule without providing an opportunity for prior public notice and comment as is normally required by the Administrative Procedure Act (APA). See 5 U.S.C. 553. The APA authorizes agencies to dispense with certain notice and comment procedures if the agency finds for good cause that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest. See 5 U.S.C. 553(b)(3)(B). “Good cause” exists in impracticable situations when notice unavoidably prevents the due and required execution of agency functions or when an agency finds that due and timely execution of its functions is impeded by the notice otherwise required by the APA. For example, an “impracticable” good cause situation might be where air safety rules should be amended without delay if the FAA determines that the safety of the traveling public is at stake. Public notice is unnecessary when the public does not need or benefit from the notice and comment, such as with a minor or technical amendment. “Public interest” supplements the other terms and requires that public rulemaking procedures must not prevent an agency from operating and that a lack of public concern warrants an agency dispensing with public procedure.

In this case, the agency finds, for good cause, that notice and public comment is impracticable, unnecessary, and contrary to the public interest. The importance of the safety of the flying public provides good cause for this measure. Here, there is a credible indication of an emerging transportation safety risk from two recent incidents involving battery-powered portable electronic smoking devices in checked baggage and additional non-transportation incidents that occurred while these types of devices were being charged. In August 2014 at Boston's Logan Airport, an e-cigarette contained in a passenger's checked bag caught fire pre-flight and caused the evacuation of an airplane. Similarly, in January 2015 at Los Angeles International Airport, a bag containing an e-cigarette was found to be on fire in a baggage area. The bag in question had missed a flight connection, and should have been in the air at the time of the incident. Although neither airplane was in the air when the fires ignited, these incidents represent two near misses for the safety of aviation passengers. E-cigarettes in checked bags present a safety risk because the devices are capable of generating extreme heat and an incident can result in the ignition of nearby contents. Carriage of e-cigarettes in the passenger cabin addresses this safety risk by ensuring that if an incident does occur, it can be immediately identified and mitigated. PHMSA believes that a delay in implementing this measure could result in serious harm to the traveling public.

Under these circumstances, notice is impracticable and contrary to the public interest. Because ICAO issued the addendum on a very short timeframe due to the gravity of the safety risk, the HMR are currently not harmonized with the ICAO Technical Instructions. Given the safety risks posed by e-cigarettes in checked baggage, PHMSA believes that public notice would frustrate the due and required execution of agency functions. Although some airlines have voluntarily complied with the SAFO recommendations, there is no domestic regulation to require continued compliance with the recently adopted ICAO amendment. Typically, PHMSA amends the HMR to conform to recent amendments to the ICAO Technical Instructions through periodic international harmonization rulemaking. If PHMSA utilized this process, this HMR amendment would become effective no earlier than January 1, 2017. The accelerated effective date of the addendum to the ICAO Technical Instructions ensures that passengers that travel on international airlines are subject to this provision before PHMSA would have time to issue a final rule through its regular harmonization rulemaking process. In light of the recent incidents and the serious harm that could result from the public safety risk of e-cigarettes in checked baggage, PHMSA believes that a delay caused by adhering to the APA notice-and-comment process to adopt conforming amendments is impracticable and contrary to the public interest.

Further, PHMSA believes that APA notice and comment would be unnecessary because the public would not benefit from such notice. The scope of this regulatory change is very limited; PHMSA is including a new entry for e-cigarettes in 49 CFR 175.10 with carriage instructions. The change does not impact whether passengers may bring their e-cigarettes on an airplane. Instead, the new language affects how the e-cigarettes must be stowed. This rulemaking does not impact the ability to travel by air with these devices. FAA's January 2015 SAFO recommended that air carriers require their passengers to carry e-cigarettes and related devices exclusively in the cabin of the aircraft. In voluntary compliance with the SAFO, many airlines instruct passengers to carry their e-cigarettes in carry-on baggage only. Because a substantial degree of compliance with this safety provision already exists through voluntary airline actions, this amendment is limited in scope yet pivotal for the safety of the traveling public. Thus, in light of the recent safety incidents and limited scope of the June 9, 2015, ICAO amendment, PHMSA has determined that the notice and comment rulemaking process is unnecessary, impracticable, and contrary to the public interest in this instance.

The DOT is taking immediate action to strengthen safeguards for the carriage of battery-powered portable electronic smoking devices in passenger checked baggage and prohibit passengers and crewmembers from charging the devices and/or batteries on board the aircraft. This interim final rule is effective seven days after publication in the Federal Register. The APA requires agencies to delay the effective date of regulations for 30 days after publication, unless the agency finds good cause to make the regulations effective sooner. See 5 U.S.C. 553(d). This interim final rule meets the good cause exception in this instance because of credible evidence from two separate incidents involving battery-powered portable electronic smoking devices in checked baggage and additional non-transportation incidents that occurred while the devices were being charged. The retroactive nature of the ICAO amendments makes a 30-day effective date impracticable and contrary to the public interest, because such a delay would further extend the time period in which the HMR does not harmonize with ICAO. Because several incidents have highlighted the safety risks of the charging and cargo carriage of these devices, the public interest is served by providing a seven-day effective date for this interim final rule.

The Regulatory Policies and Procedures of DOT (44 FR 110034; February 26, 1979) provide that, to the maximum extent possible, DOT operating administrations should provide an opportunity for public comment on regulations issued without prior notice. Accordingly, PHMSA encourages persons to participate in this rulemaking by submitting comments containing relevant information, data, or views. We will consider all comments received on or before the closing date for comments. We will consider late filed comments to the extent practicable. This interim final rule may be amended based on comments received.

This interim final rule is published under authority of Federal hazardous materials transportation law (Federal hazmat law; 49 U.S.C. 5101 et seq.) and 49 U.S.C. 44701. Section 5103(b) of Federal hazmat law authorizes the Secretary of Transportation to prescribe regulations for the safe transportation, including security, of hazardous material in intrastate, interstate, and foreign commerce. 49 U.S.C. 44701 authorizes the Administrator of the Federal Aviation Administration to promote safe flight of civil aircraft in air commerce by prescribing regulations and minimum standards for practices, methods, and procedures the Administrator finds necessary for safety in air commerce and national security. 49 U.S.C. 5120(b) authorizes the Secretary of Transportation to ensure that, to the extent practicable, regulations governing the transportation of hazardous materials in commerce are consistent with standards adopted by international authorities. This final rule is amending the HMR to maintain alignment with the ICAO Technical Instructions.

The Department has determined that the transportation of battery-powered portable electronic smoking devices in checked baggage is an immediate safety threat. Therefore, this rule is being issued to address an emergency situation within the meaning of Section 6(a)(3)(D) of Executive Order 12866. Under section 6(a)(3)(D), in emergency situations, an agency must notify OMB as soon as possible and, to the extent practicable, comply with subsections (a)(3)(B) and (C) of section 6 of EO 12866. The Department has notified and consulted with OMB on this interim final rule. We do not anticipate the actions in this interim final rule will impose a significant impact on airlines, airline passengers, crewmembers, or the Federal government. We expect airlines will incur minimal costs associated with updating notifications to airline passengers (e.g. Web sites, automated check-in facilities, signage and verbal notifications from the operator). Airlines already have mechanisms to notify airline passengers of hazardous materials restrictions and we expect that airlines would incorporate this additional provision into existing notifications. Airline passengers will still be permitted to carry their e-cigarettes in their carry-on baggage or on their person. Spare lithium batteries must be individually protected so as to prevent short circuits (by placement in original retail packaging or by otherwise insulating terminals, e.g., by taping over exposed terminals or placing each battery in a separate plastic bag or protective pouch). This is consistent with existing requirements for the carriage of spare lithium batteries for portable electronic devices. We do not anticipate this would result in any impact on passengers because these devices are a type of portable electronic device and spare lithium batteries for portable electronic devices are already required to be protected from short circuits and carried in carry-on baggage only. Some passengers may incur a non-quantifiable cost in the lost opportunity to charge their device while on board the aircraft. We expect that this will be a small number of passengers and that the per-passenger cost will also be small. The Transportation Security Administration may incur new costs associated with amending security procedures for checked baggage to inform security officers that these items should be treated as hazardous materials. PHMSA welcomes public comments on potential costs and benefits of this regulatory action.

Under the Department of Transportation's Regulatory Policies and Procedures (44 FR 11034), this rule is considered to be an emergency regulation. The Department has determined that an immediate safety threat exists in the carriage of battery-powered portable electronic smoking devices in checked baggage and, therefore, this rule is considered to be an emergency regulation. Because of the need to move quickly to address this risk, it would be impractical, unnecessary, and contrary to the public interest to follow the usual procedures under the DOT order.

This final rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13132 (“Federalism”). This rule preempts State, local and Indian tribe requirements but does not impose any regulation that has substantial direct effects on the States, the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. Therefore, the consultation and funding requirements of Executive Order 13132 do not apply.

The Federal hazardous materials transportation law, 49 U.S.C. 5101-27, contains express preemption provisions (49 U.S.C. 5125) that preempt inconsistent State, local, and Indian tribe requirements, including requirements on the following subjects:

(1) The designation, description, and classification of hazardous materials;

(2) The packing, repacking, handling, labeling, marking, and placarding of hazardous materials;

(3) The preparation, execution, and use of shipping documents related to hazardous materials and requirements related to the number, contents, and placement of those documents;

(4) The written notification, recording, and reporting of the unintentional release in transportation of hazardous material; or

(5) The design, manufacture, fabrication, marking, maintenance, recondition, repair, or testing of a packaging or container represented, marked, certified, or sold as qualified for use in transporting hazardous material.

This rule addresses subject items (1) and (2) described above and, accordingly, State, local, and Indian tribe requirements on these subjects that do not meet the “substantively the same” standard will be preempted.

Federal hazardous materials transportation law provides at § 5125(b)(2) that, if DOT issues a regulation concerning any of the covered subjects, DOT must determine and publish in the Federal Register the effective date of Federal preemption. The effective date may not be earlier than the 90th day following the date of issuance of a final rule and not later than two years after the date of issuance. The effective date of Federal preemption is 90 days from publication of this interim final rule in this matter in the Federal Register. This effective date for preemptive effect should not provide a conflict with the overall effective date for this interim final rule because the FAA Act, and various court decisions dealing with the regulation of air transport, generally preempts State and local requirements. Historically the States and localities are aware of this preemptive effect and do not regulate in conflict with Federal requirements in these situations.

This final rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13175 (“Consultation and Coordination with Indian Tribal Governments”). Because this interim final rule does not have tribal implications and does not impose direct compliance costs, the funding and consultation requirements of Executive Order 13175 do not apply.

Section 603 of the Regulatory Flexibility Act (RFA) requires an agency to prepare an initial regulatory flexibility analysis describing impacts on small entities whenever an agency is required by 5 U.S.C. 553 to publish a general notice of proposed rulemaking for any proposed rule. Similarly, section 604 of the RFA requires an agency to prepare a final regulatory flexibility analysis when an agency issues a final rule under 5 U.S.C. 553 after being required to publish a general notice of proposed rulemaking. Because of the need to move quickly to address the identified risk, prior notice and comment would be contrary to the public interest. As prior notice and comment under 5 U.S.C. 553 are not required to be provided in this situation, the analyses in 5 U.S.C.s 603 and 604 are not required.

This rule does not impose unfunded mandates under the Unfunded Mandates Reform Act of 1995. It does not result in costs of $155,000,000 or more, adjusted for inflation, to either State, local or tribal governments, in the aggregate, or to the private sector in any one year, and is the least burdensome alternative that achieves the objective of the rule.

There are no new information collection requirements in this final rule.

A regulation identifier number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN number contained in the heading of this document may be used to cross-reference this action with the Unified Agenda.

The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321-4347), requires Federal agencies to consider the consequences of major Federal actions and prepare a detailed statement on actions significantly affecting the quality of the human environment. This interim final rule prohibits the carriage of battery-powered portable electronic smoking devices in checked baggage and the charging of such devices on board a passenger-carrying aircraft. Airline passengers will still be permitted to carry their e-cigarettes in their carry-on baggage or on their person. In other words, the interim final rule only impacts how a passenger may carry battery-powered portable electronic smoking devices on aircraft, not whether a passenger can carry such devices. We find that there are no significant environmental impacts associated with this interim final rule.

Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the document (or signing the document, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit http://www.regulations.gov/search/footer/privacyanduse.jsp

In consideration of the foregoing, we amend 49 CFR Chapter I as follows:

Executive Summary Purpose of the Regulatory Action

This is a final rule to designate the black-footed ferret (Mustela nigripes) nonessential experimental population (NEP) area in the State of Wyoming in accordance with section 10(j) of the Endangered Species Act (Act). This designation increases the Service's flexibility and discretion in managing reintroduced endangered species and allows promulgation of regulations deemed appropriate for conservation of the reintroduced species. We have determined that the issuance of this rule will advance the recovery of the endangered black-footed ferret. Specifically, this rulemaking will facilitate the establishment of free-ranging populations of ferrets within the species' historical range in Wyoming, thereby contributing to the numerical and distributional population targets laid out in the recovery plan's delisting and downlisting (reclassifying from endangered to threatened) criteria (U.S. Fish and Wildlife Service 2013a, p. 6)

Under section 10(j) of the Act and our regulations at 50 CFR 17.81, the Service may establish an NEP, outside of the current range of the species, but within its historical range, for the purposes of reintroducing the species into formerly occupied habitat. Under this 10(j) rule, the Service is classifying any reestablished black-footed ferret population in the State of Wyoming as an NEP. The Service has determined that this NEP designation meets the requirements of the Act; the population is wholly geographically separate from other populations, and the experimental population is not essential to the continued existence of the black-footed ferret in the wild.

This NEP designation will apply to all ferrets reintroduced to Wyoming, with the exception of animals found on lands managed by the National Park Service or U.S. Fish and Wildlife Service. Under a section 10(j) designation as an NEP, both the take prohibitions and consultation requirements of the Act are relaxed, easing regulatory burden associated with endangered species and facilitating acceptance by local landowners and managers.

Once this rule takes effect, the Service, the Wyoming Game and Fish Department (WGFD), and other partners propose to reintroduce the black-footed ferret at one or more additional sites within the species' historical range in Wyoming. The WGFD will serve as the lead agency in the reintroduction and subsequent management of black-footed ferret in Wyoming; however, WGFD will continue to coordinate closely with the Service on these restoration efforts.

Costs and benefits of a Statewide NEP designation in Wyoming will depend upon the number and type of reintroduction efforts initiated. The Black-footed Ferret Recovery Plan estimates that 35,000 acres (ac) (14,000 hectares (ha)) of purposefully managed prairie dog occupied habitat will be needed to meet Wyoming's portion of the rangewide habitat goal for downlisting, and 70,000 ac (28,000 ha) to meet their portion of the rangewide habitat goal for delisting (USFWS 2013a, Table 8). This equates to purposeful management of approximately 2 percent of prairie dog occupied habitat in Wyoming to meet their portion of the rangewide habitat goal for delisting. We completed an environmental assessment for this action, which analyzes potential impacts of reestablishing black-footed ferrets in Wyoming under section 10(j) of the Act. Participation in this recovery effort is entirely voluntary and would not occasion any substantive change in land use by participants; consequently, we anticipate that the benefits of reintroduction will off-set the costs incurred for any recovery partners who choose to participate.

The black-footed ferret was listed as endangered throughout its range on March 11, 1967 (32 FR 4001), and again on June 2, 1970 (35 FR 8491), under early endangered species legislation and was “grandfathered” under the Endangered Species Act of 1973, as amended (Act; 16 U.S.C. 1531 et seq.) without critical habitat. The Act provides that species listed as endangered are afforded protection primarily through the prohibitions of section 9 and the requirements of section 7. Section 9 of the Act, among other things, prohibits the take of endangered wildlife. “Take” is defined by the Act as harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or attempt to engage in any such conduct. Section 7 of the Act outlines the procedures for Federal interagency cooperation to conserve federally listed species and protect designated critical habitat. It mandates that all Federal agencies use their existing authorities to further the purposes of the Act by carrying out programs for the conservation of listed species. It also states that Federal agencies must, in consultation with the Service, ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. Section 7 of the Act does not affect activities undertaken on private land unless they are authorized, funded, or carried out by a Federal agency.

The 1982 amendments to the Act (16 U.S.C. 1531 et seq.) included the addition of section 10(j), which allows for the designation of reintroduced populations of listed species as “experimental populations.” Under section 10(j) of the Act and our regulations at 50 CFR 17.81, the Service may designate as an experimental population a population of endangered or threatened species that has been or will be released into suitable natural habitat outside the species' current natural range (but within its probable historical range, absent a finding by the Director of the Service in the extreme case that the primary habitat of the species has been unsuitable and irreversibly altered or destroyed). With the experimental population designation, the relevant population is treated as threatened for purposes of section 9 of the Act, regardless of the species' designation elsewhere in its range. Threatened designation allows us discretion in devising management programs and special regulations for such a population. Section 4(d) of the Act allows us to adopt whatever regulations are necessary and advisable to provide for the conservation of a threatened species. In these situations, the general regulations that extend most section 9 prohibitions to threatened species do not apply to that species, and the rule issued under section 10(j) of the Act (hereafter referred to as a 10(j) rule) contains the prohibitions and exemptions necessary and appropriate to conserve that species.

Before authorizing the release as an experimental population of any population (including eggs, propagules, or individuals) of an endangered or threatened species, and before authorizing any necessary transportation to conduct the release, the Service must find, by regulation, that such release will further the conservation of the species. In making such a finding, the Service uses the best scientific and commercial data available to consider: (1) Any possible adverse effects on extant populations of a species as a result of removal of individuals, eggs, or propagules for introduction elsewhere; (2) the likelihood that any such experimental population will become established and survive in the foreseeable future; (3) the relative effects that establishment of an experimental population will have on the recovery of the species; and (4) the extent to which the introduced population may be affected by existing or anticipated Federal or State actions or private activities within or adjacent to the experimental population area.

Furthermore, as set forth in 50 CFR 17.81(c), all regulations designating experimental populations under section 10(j) must provide: (1) Appropriate means to identify the experimental population, including, but not limited to, its actual or proposed location, actual or anticipated migration, number of specimens released or to be released, and other criteria appropriate to identify the experimental population(s); (2) a finding, based solely on the best scientific and commercial data available, and the supporting factual basis, on whether the experimental population is, or is not, essential to the continued existence of the species in the wild; (3) management restrictions, protective measures, or other special management concerns of that population, which may include but are not limited to, measures to isolate and/or contain the experimental population designated in the regulation from natural populations; and (4) a process for periodic review and evaluation of the success or failure of the release and the effect of the release on the conservation and recovery of the species.

Under 50 CFR 17.81(d), the Service must consult with appropriate State fish and wildlife agencies, local governmental entities, affected Federal agencies, and affected private landowners in developing and implementing experimental population rules. To the maximum extent practicable, section 10(j) rules represent an agreement between the Service, the affected State and Federal agencies, and persons holding any interest in land which may be affected by the establishment of an experimental population.

Based on the best scientific and commercial data available, we must determine whether the experimental population is essential or nonessential to the continued existence of the species. The regulations (50 CFR 17.80(b)) state that an experimental population is considered essential if its loss would be likely to appreciably reduce the likelihood of survival of that species in the wild. All other populations are considered nonessential. We have determined that any future experimental populations of black-footed ferrets in Wyoming would not be essential to the continued existence of the species in the wild. This determination has been made because loss of an experimental population in Wyoming will not affect the captive population or the 24 existing reintroduction sites in Arizona, Colorado, Kansas, Montana, New Mexico, South Dakota, Utah, and Wyoming; in Chihuahua, Mexico; and in Saskatchewan, Canada. Therefore, loss of an experimental population in Wyoming will not appreciably reduce the likelihood of future survival of the ferret rangewide.

For the purposes of section 7 of the Act, we treat an NEP as a threatened species only when the NEP is located within a National Wildlife Refuge or unit of the National Park Service. In these areas, the Federal agency conservation requirements under section 7(a)(1) and the Federal agency consultation requirements of section 7(a)(2) of the Act apply. Section 7(a)(1) requires all Federal agencies to use their authorities to carry out programs for the conservation of listed species. Section 7(a)(2) requires that Federal agencies, in consultation with the Service, ensure that any action authorized, funded, or carried out is not likely to jeopardize the continued existence of a listed species or adversely modify its critical habitat.

When NEPs are located outside a National Wildlife Refuge or National Park Service unit, then, for the purposes of section 7, we treat the population as proposed for listing and only section 7(a)(1) and section 7(a)(4) apply. In these instances, NEPs provide additional flexibility because Federal agencies are not required to consult with us under section 7(a)(2). Section 7(a)(4) requires Federal agencies to confer (rather than consult) with the Service on actions that are likely to jeopardize the continued existence of a species proposed to be listed. The results of a conference are in the form of conservation recommendations that are optional as the agencies carry out, fund, or authorize activities. Because the NEP is, by definition, not essential to the continued existence of the species, the effects of proposed actions affecting the NEP will generally not rise to the level of jeopardizing the continued existence of the species. As a result, a formal conference will likely never be required for black-footed ferrets established within the NEP area. Nonetheless, some agencies voluntarily confer with the Service on actions that may affect a proposed species. Activities that are not carried out, funded, or authorized by Federal agencies are not subject to provisions or requirements in section 7.

On April 10, 2015, the Service published a proposed rule in the Federal Register to establish a nonessential experimental population of black-footed ferrets in Wyoming, and announced the availability of a draft environmental assessment (EA) in accordance with the National Environmental Policy Act of 1969, as amended (NEPA) (80 FR 19263). This EA analyzed the potential environmental impacts associated with the proposed reintroduction of ferrets in Wyoming. We contacted interested parties including Federal and State agencies, local governments, scientific organizations, interest groups, and private landowners through a press release and related fact sheets, and emails. In addition, we notified the public and invited comments through news releases to local media outlets. The public comment period for the proposed rule and the draft EA closed on June 9, 2015. Prior to the April 10, 2015, publication of the proposed rule, we also held a series of informational public meetings across the State in concert with Wyoming Game and Fish Department.

Section 10(j)(2)(C)(ii) of the Act states that critical habitat shall not be designated for any experimental population that is determined to be nonessential. Accordingly, we cannot designate critical habitat in areas where we establish an NEP.

The endangered black-footed ferret is the only ferret species native to the Americas (Anderson et al. 1986, p. 24). It is a medium-sized mustelid, typically weighing 1.4 to 2.5 pounds (645 to 1,125 grams) and measuring 19 to 24 inches (479 to 600 millimeters) in total length; upper body parts are yellowish buff, occasionally whitish, feet and tail tip are black, and a black “mask” occurs across the eyes (Hillman and Clark 1980, p. 30).

The black-footed ferret depends almost exclusively on prairie dogs for food and on prairie dog burrows for shelter (Hillman 1968, p. 438; Biggins 2006, p. 3). Historical habitat of the ferret coincided with the ranges of the black-tailed prairie dog (Cynomys ludovicianus), white-tailed prairie dog (C. leucurus), and Gunnison's prairie dog (C. gunnisoni), which collectively occupied approximately 100 million ac (40 million ha) of intermountain and prairie grasslands extending from Canada to Mexico (Anderson et al. 1986, pp. 25-50; Biggins et al. 1997, p. 420). This amount of prairie dog habitat could have supported 500,000 to 1,000,000 ferrets (Anderson et al. 1986, p. 58). Since the late 1800s, ferret specimens have been collected from Arizona, Colorado, Kansas, Montana, Nebraska, New Mexico, North Dakota, Oklahoma, South Dakota, Texas, Utah, and Wyoming in the United States and Saskatchewan and Alberta in Canada (Anderson et al. 1986, pp. 25-50). In the 1990s, we concluded that the ferret's historical range also included Mexico, which is within the contiguous range of the black-tailed prairie dog as previously noted (Biggins et al. 1997, p. 420). This inclusion of Mexico in the ferret's historical range is described in more detail in the recovery plan and resulted in a ferret reintroduction initiated in 2001 (USFWS 2013a, pp. 16-17). This final rule also corrects the historical range of the species at 50 CFR 17.11(h); this action has no regulatory impact as this column is strictly informational.

Black-footed ferrets historically occurred throughout most of Wyoming. Specifically, black-footed ferrets occurred within black-tailed prairie dog habitat in the eastern portion of the State and white-tailed prairie dog habitat in the west; black-footed ferrets did not occur in the extreme northwest corner of the State (Anderson et al. 1986, p. 48). The last wild population of ferrets (from which all surviving black-footed ferrets descend) was discovered near Meeteetse, Wyoming, in 1981, after the species was presumed extinct (Clark et al. 1986, p. 8; Lockhart et al. 2006, p. 8). Following disease outbreaks at Meeteetse, all surviving wild ferrets were removed from the wild between 1985 and 1987, to initiate a captive-breeding program (Lockhart et al. 2006, p. 8). No wild populations have been found since the capture of the last Meeteetse ferret despite extensive and intensive rangewide searches; it is unlikely that any undiscovered wild populations remain. Therefore, the Service considers the State of Wyoming unoccupied by wild ferrets, with the exception of reintroduced populations, which alleviates the requirement for project proponents to conduct presence/absence surveys for ferrets under section 7 of the Act prior to developing projects (USFWS 2013c).

In 1991, a reintroduced population of ferrets was established in Shirley Basin, Wyoming as an NEP in accordance with section 10(j) of the Act. In 2001, the Wolf Creek, Colorado, reintroduction site was also established as an NEP under section 10(j), and includes a small portion of Sweetwater County, Wyoming, in the experimental population area. However, no evidence of ferrets from the Wolf Creek reintroduction effort has been found in Sweetwater County or elsewhere in Wyoming. The Shirley Basin NEP persists today. The map at the conclusion of this rule identifies the existing NEPs in Wyoming.

All known black-footed ferrets in the wild are the result of reintroduction efforts. There have been 24 ferret reintroduction projects, beginning in 1991, at Shirley Basin in the southeastern portion of Wyoming. Shirley Basin contains the only ferret population currently in Wyoming.

The downlisting criteria for the black-footed ferret include establishing at least 1,500 free-ranging breeding adults in 10 or more populations, in at least 6 of 12 States within the historical range of the species, with no fewer than 30 breeding adult ferrets in any population; delisting criteria include establishing at least 3,000 free-ranging breeding adults in 30 or more populations, in at least 9 of 12 States within the historical range of the species, with no fewer than 30 breeding adults in any population (USFWS 2013a, pp. 61-62). In our recovery plan for the ferret, we suggest recovery guidelines for the States that are proportional to the amount of prairie dog habitat historically present. A proportional share for Wyoming would include approximately 171 free-ranging breeding adult ferrets to meet their portion of the rangewide numerical goal for downlisting and 341 breeding adults to meet their portion of the rangewide numerical goal for delisting (USFWS 2013a, Table 8).

Approximately 100 breeding adult black-footed ferrets have been established at Shirley Basin, Wyoming (USFWS 2013a, Table 8). Shirley Basin is one of four currently successful ferret reintroduction sites—other successful sites include two in South Dakota and one in Arizona (USFWS 2013a, p. 73). We are confident that Wyoming can support additional successful reintroduction sites, based on the amount of available habitat (see the following section on Likelihood of Population Establishment and Survival) and a history of successful ferret management at Shirley Basin since 1991. Additional viable ferret populations within Wyoming will aid recovery of the species.

The NEP area for Wyoming is Statewide, with the exception of the two areas where a NEP designation for black-footed ferret already exists (see below). In combination, these three NEPs collectively cover the entire State of Wyoming. Suitable habitat for ferret reintroduction will likely be limited to Albany, Big Horn, Campbell, Carbon, Converse, Crook, Fremont, Goshen, Hot Springs, Johnson, Laramie, Lincoln, Natrona, Niobrara, Park, Platte, Sheridan, Sublette, Sweetwater, Uinta, Washakie, and Weston Counties because these counties have sufficient prairie dog habitat to support viable ferret populations. We are not aware of any prairie dog complexes suitable for ferret reintroduction on or adjacent to Tribal lands in Wyoming. The nearest potential reintroduction sites to Tribal lands are two white-tailed prairie dog complexes--Fifteen-mile Complex near Worland in Hot Springs County and Sweetwater Complex near Sweetwater Station in Fremont County (Luce 2008, pp. 29-30). Both sites are of intermediate potential for ferret reintroduction and are located approximately 19 miles (30 kilometers) from any reservation boundaries.

Any ferrets found in Wyoming would be considered part of an NEP. There are many historical records of ferrets in Wyoming (Anderson et al. 1986, pp. 36-37). However, the species has been extirpated from the State since 1987, with the exception of a reintroduced ferret population in the Shirley Basin. As previously noted, a 10(j) designation already exists for the Shirley Basin ferret population in Albany County and portions of Carbon and Natrona Counties that are east of the North Platte River. A 10(j) designation also exists for the Wolf Creek, Colorado, ferret reintroduction site, which includes a small portion of Sweetwater County in Wyoming. Both of these reintroduction sites would remain outside the boundary of this newly designated NEP area and would continue to operate under their respective management plans. Any new reintroduction sites within this newly designated NEP area would require development of a new management plan approved by the Service.

Several sites in Wyoming are suitable for reintroduction of black-footed ferrets in addition to the Shirley Basin site. The main requirements for ferret reintroduction are: (1) An area of occupied prairie dog habitat that is purposefully managed and of sufficient size to support a viable population of ferrets (a minimum of 1,500 ac (608 ha) of black-tailed prairie dog occupied habitat or 3,000 ac (1,215 ha) of white-tailed or Gunnison's prairie dog occupied habitat); (2) a willing landowner; and (3) a management plan that addresses sylvatic plague. Recent estimates of prairie dog occupied habitat in Wyoming include 2,893,487 ac (1,171,862 ha) in the white-tailed prairie dog range and 229,607 ac (92,991 ha) in the black-tailed prairie dog range (Van Pelt 2013, pp. 8, 14). Luce (2008, pp. 28-31) identified several sites in Wyoming with potential for ferret reintroduction including one site with potential for reintroduction within less than 3 years, 24 sites with potential for reintroduction within 3 to 10 years, and two sites with long-term potential for reintroduction.

The Service and its partners have initiated 24 black-footed ferret reintroduction projects since 1991. These projects have experienced varying degrees of success. However, all reintroduction efforts have contributed to our understanding of the species' needs. Recovery of the species is a dynamic process that requires adaptive management.

Some transfers of individual black-footed ferrets between populations will likely be necessary in perpetuity to maintain genetic diversity in the face of habitat fragmentation and as a management tool for sylvatic plague (until additional plague vaccines can be adapted for field use). Nevertheless, we believe that recovery can be achieved through a combination of expansion of ferret populations at existing reintroduction sites and reintroduction of ferrets at new sites, both of which are possible if conservation of prairie dog occupied habitat and disease management are aggressively pursued.

Participation by all States within the historical range of the black-footed ferret is important to maximize resilience of ferret populations in the wild and to allow for an equitable distribution of the responsibility for achieving recovery goals. Federal, State, and local agencies in Wyoming have been active participants in ferret recovery since the last wild population was found at Meeteetse in 1981. We estimate 100 breeding adult ferrets are already established at Shirley Basin. The suggested numerical recovery guidelines for Wyoming are 171 breeding adults to support the State's share of the rangewide downlisting target and 341 breeding adults to support the State's share of the rangewide delisting target. Meeting their portion of the rangewide numerical goal for downlisting would require establishing one additional large reintroduction site similar to Shirley Basin or two to three smaller sites. Meeting their portion of the rangewide numerical goal for delisting would require establishing two large sites, six small sites, or a combination of large, medium, and small sites, in addition to the sites previously established for meeting their portion of the rangewide numerical goal for downlisting. The Recovery Plan estimates that 35,000 ac (14,000 ha) of purposefully managed prairie dog occupied habitat will be needed to meet Wyoming's portion of the rangewide habitat goal for downlisting and 70,000 ac (28,000 ha) to meet their portion of the rangewide habitat goal for delisting (USFWS 2013a, Table 8). This equates to purposeful management of approximately 2 percent of prairie dog occupied habitat in Wyoming to meet their portion of the rangewide habitat goal for delisting.

Sustaining black-footed ferret numbers during periodic outbreaks of sylvatic plague will require ongoing management, potentially including dusting prairie dog burrows with flea control powder and vaccinating ferrets prior to release. Additionally, research is currently underway investigating the potential for supporting ferrets at reintroduction sites by providing a vaccine to wild prairie dogs via oral bait.

Based upon the past history of successful management at Shirley Basin, Wyoming, and the substantial amount of prairie dog occupied habitat available for additional reintroduction of black-footed ferrets, we believe there is a high likelihood of population establishment and survival in Wyoming.

The black-footed ferret rangewide population declined for three principal reasons: (1) A major conversion of native rangeland to cropland, particularly in the eastern portion of the species' range, beginning in the late 1800s; (2) poisoning of prairie dogs to reduce competition with domestic livestock for forage, beginning in the early 1900s; and (3) the inadvertent introduction of sylvatic plague, which causes mortality to both ferrets and prairie dogs, beginning in the 1930s. The combined effects of these three factors resulted in a rangewide decrease in the amount of habitat occupied by prairie dogs from approximately 100 million ac (40.5 million ha) historically to 1.4 million ac (570,000 ha) in the 1960s (USFWS 2013a, pp. 23-24). This habitat loss and fragmentation resulted in a corresponding decrease in ferrets, which require relatively large areas of prairie dog occupied habitat to maintain viable populations. By the 1960s, only two remnant ferret populations remained—in Mellette County, South Dakota, and in Meeteetse, Wyoming (Lockhart et al. 2006, pp. 7-8).

Wyoming has had less rangeland converted to cropland than most other States within the historical range of the black-footed ferret (U.S. Department of Agriculture 2005, Table 1). Consequently, prairie dog poisoning and sylvatic plague are likely the two primary reasons for extirpation of ferrets from the State. Extensive poisoning of prairie dogs had begun in Wyoming by 1916 (Clark 1973, p. 89), and plague was present in Wyoming by 1936 (Eskey and Haas 1940, p. 4). Occupied prairie dog habitat reached a low in Wyoming in the early 1960s when approximately 64,336 ac (26,056 ha) were reported (U.S. Bureau of Sport Fisheries and Wildlife 1961, Table 1). However, large-scale poisoning of prairie dogs no longer occurs, and the use of poisons is more closely regulated than it was historically. Improved plague management, including dusting prairie dog burrows with insecticide to control fleas (the primary vector for plague transmission), is also being used, and the development of vaccines that prevent plague in prairie dogs and black-footed ferrets is underway. The most recent surveys estimate 3,123,094 ac (1,264,853 ha) of occupied prairie dog habitat in Wyoming (Van Pelt 2013, pp. 8, 14). This considerable increase over the past 50 years indicates that there has been a reduction in threats and improved management of prairie dogs. This increases the likelihood of successful reintroduction of ferrets in Wyoming.

The Service will cooperate with other Federal agencies, WGFD, Tribes, landowners, and other stakeholders to develop, implement, and maintain long-term site management before, during, and after releases. Partners will collect habitat data for site evaluation and documentation of baseline conditions and develop management plans for prairie dogs and plague prior to any release of black-footed ferrets. All applicable laws regulating the protection of ferrets will be followed (see section on Management Considerations and Protective Measures, below). Partners will develop annual site-specific reintroduction plans and submit them to the Service by mid-March as part of an annual ferret allocation process (which allocates available captive ferrets for release in specific numbers for specific sites). Reintroduction plans will include current estimates of prairie dog numbers and density, disease prevalence and management, and proposed reintroduction and monitoring methods. If the reintroduction plan covers years subsequent to the initial releases, it will also include a recent description of the status of ferrets on the site.

All reintroduction efforts will follow techniques described in Roelle et al. (2006) as appropriate, which presents recommendations for managing captive populations, evaluating potential habitat, reestablishing populations, and managing disease. Captive-reared black-footed ferrets exposed to prairie dog burrows and natural prey in outdoor preconditioning pens prior to their release survive in the wild at significantly higher rates than cage-reared, non-preconditioned ferrets (Biggins et al. 1998, pp. 651-652; Vargas et al. 1998, p. 77). Therefore, all captive-reared ferrets released within the Wyoming NEP area will receive adequate preconditioning in outdoor pens at the National Black-footed Ferret Conservation Center or at another facility approved by the Service. We will vaccinate all ferrets for canine distemper and sylvatic plague, and mark them with passive integrated transponder tags prior to release. We will transport ferrets to the reintroduction site and release them directly from transport cages into prairie dog burrows. In conformance with standard ferret reintroduction protocol, no fewer than 20 captive-raised or wild-translocated ferrets will be released at any reintroduction site in Wyoming during the first year of the project. Twenty or more additional animals will be released annually for the next 2 to 4 years. Released ferrets will be excess to the needs of the captive-breeding program.

Eighteen black-footed ferrets were captured from the last wild population at Meeteetse, Wyoming in 1985-1987, and used to initiate a captive-breeding program (Lockhart et al. 2006, pp. 11-12). Of the 18 captured ferrets, 15 individuals, representing the genetic equivalent of 7 distinct founders, produced a captive population that is the foundation of present recovery efforts (Garelle et al. 2006, p. 4). Extant populations, both captive and reintroduced, descend from these “founder” animals. The purpose of the captive-breeding program is to provide animals for reintroduction to achieve recovery of the species, while maintaining maximum genetic diversity in the captive population (USFWS 2013a, p. 81).

Black-footed ferrets used to establish any experimental population in the Wyoming NEP area will either be translocated wild-born kits from another self-sustaining reintroduced population (such as Shirley Basin) or come from one of six captive-breeding populations currently housed at the U.S. Fish and Wildlife Service National Black-footed Ferret Conservation Center near Wellington, Colorado; the Cheyenne Mountain Zoological Park, Colorado Springs, Colorado; the Louisville Zoological Garden, Louisville, Kentucky; the Smithsonian Biology Conservation Institute, Front Royal, Virginia; the Phoenix Zoo, Phoenix, Arizona; or the Toronto Zoo, Toronto, Ontario.

The Service and its partners maintain a captive-breeding population of approximately 280 breeding adult black-footed ferrets in order to provide a sustainable source of ferrets for reintroduction. The captive-breeding facilities produce approximately 120 to 240 juvenile ferrets annually. Approximately 80 juveniles are retained annually at these facilities for future captive-breeding purposes. The remaining juveniles are allocated annually for reintroduction, or occasionally for research (USFWS 2013a, p. 81). Ferrets selected for reintroduction under this final rule will be genetically redundant to animals maintained for captive-breeding. Consequently, any loss of reintroduced ferrets will not impact the genetic diversity of the species. Only ferrets that are surplus to the needs of the captive-breeding program are used for reintroduction into the wild. Therefore, any loss of an experimental population in the wild will not threaten the survival of the species as a whole. Therefore, there will be no effects on donor populations beyond those which are intended and accounted for in the management of wild or captive populations.

The effects of using black-footed ferrets from any captive or wild-born donor populations for releases into the Wyoming NEP area will be examined through our section 10 permitting authority and section 7 consultation process to ensure that their use is not likely to jeopardize the continued existence of the species in the wild. We based this determination on the following: (1) As an NEP, black-footed ferrets utilized for reintroductions are not essential to the survival of the species; (2) The 10(j) rule is expected to result in the creation of additional reintroduction areas in Wyoming; (3) Measures to avoid and minimize the incidental take of black-footed ferrets will be implemented within reintroduced populations; (4) The 10(j) rule will likely constitute a beneficial effect for the black-tailed and white-tailed prairie dog, as it includes measures to reduce the incidence of sylvatic plague, the primary factor responsible for the decline of these two species. This will result in an increase in the reproduction, numbers and distribution of the black-footed ferret, and therefore not resulting in reducing appreciably the likelihood of survival and recovery.

Additional successful reintroductions of ferrets are necessary for recovery of the species. Once this rule takes effect (see DATES, above), any releases of ferrets in Wyoming will be part of an NEP because of the need for increased management flexibility, which will encourage landowner participation and alleviate concerns regarding possible land use restrictions.

This 10(j) rule is designed to broadly exempt from the section 9 take prohibitions any take of black-footed ferrets that is incidental to otherwise lawful activities. We provide this exemption because we believe that such incidental take of members of the NEP associated with otherwise lawful activities is necessary and advisable for the conservation of the species.

This designation is justified because no adverse effects to extant wild or captive black-footed ferret populations will result from release of progeny from either a wild or captive donor population onto a new reintroduction site. We also expect that any reintroduction efforts in Wyoming will result in the successful establishment of a self-sustaining population, which will contribute to the recovery of the species.

We conclude that the effects of Federal, State, or private actions and activities will not pose a substantial threat to black-footed ferret establishment and persistence in Wyoming because most activities currently occurring in the NEP area are compatible with ferret recovery and there is no information to suggest that future activities would be incompatible with ferret recovery. We base this conclusion on experience at previous reintroduction sites, where incidental take associated with otherwise lawful activities such as ranching and energy development has been low. Poisoning of prairie dogs can occur in prairie dog habitat and could result in habitat loss or incidental take of ferrets. However, poisoning within a reintroduction site is very restricted, occurring only in specific instances where protection of residences, resources, or infrastructure on participating farm and ranch lands becomes necessary. These considerations are planned for in cooperation with participating landowners and stakeholders and documented in site-specific management plans that must be approved by the Service before ferrets are allocated to any reintroduction sites. Poisoning with the anticoagulant Rozol® at current and future reintroduction sites, however, is prohibited by Environmental Protection Agency label that governs use of Rozol (USFWS 2013a, p. 50). Prairie dog control programs may also be necessary at the boundary between ferret reintroduction sites and adjacent properties in order to maintain local support for the reintroduction. If boundary control is necessary because prairie dogs have encroached onto adjacent properties where prairie dogs are not wanted, it is carefully managed. Lethal control of prairie dogs should not be employed at a level that would reduce prairie dog occupied habitat to the extent that the viability of any potential ferret population is compromised—a minimum of 1,500 ac (608 ha) of black-tailed prairie dog occupied habitat or 3,000 ac (1,215 ha) of white-tailed or Gunnison's prairie dog occupied habitat is needed to sustain a viable ferret population.

The Service will coordinate closely with WGFD and other partners in the management of any black-footed ferrets in Wyoming that are reintroduced under section 10(j) authorities. Management of ferret populations in the Wyoming NEP area will be guided by provisions in site-specific management plans developed by partners (WGFD) with input from any affected landowners and stakeholders such as U.S Animal and Plant Health Inspection Service, U.S. Bureau of Land Management (BLM), U.S. Forest Service (USFS), Natural Resources Conservation Service, Wyoming Department of Agriculture, or potentially affected Tribes. The responsibilities and commitments of the participating agencies will be documented in the management plan. As mentioned above, management plans must be approved by the Service before ferrets are allocated to any reintroduction sites.

Management plans will be site-specific with management strategies based on site-specific characteristics (e.g., prairie dog distribution and expansion potential, sylvatic plague history, ferret movement barriers) and land use patterns (e.g., livestock grazing, recreational use, mineral development potential). Management plans are tailored to achieve conservation objectives using management strategies compatible with existing ranch, livestock, and mineral extraction operations so that neither lifestyles nor income potential are negatively affected. We expect that future management plans under this 10(j) rule will have many similarities to past plans for other reintroduction sites. Some examples of management strategies for Shirley Basin in Wyoming include: (1) Attempting to schedule ferret releases so overlap with hunting opening weekends does not occur; (2) allowing landowners and land managers the opportunity to cooperatively decide the number and distribution of prairie dogs (and correspondingly ferrets) that may occur on privately owned and leased lands; (3) annually obtaining landowner approval of human activity necessary for actions specified in this plan; (4) biannual review of the progress of ongoing activities by all concerned parties. Other management plans may contain provisions similar to these, although the specific content and details will vary by site.

Most of the area containing suitable release sites with high potential for ferret establishment is managed by the BLM, the USFS, or private landowners, and is currently protected through the following mechanisms.

(1) Federal Land Policy and Management Act of 1976 (43 U.S.C. 1701 et seq.)—The BLM's mission is set forth under the Federal Land Policy and Management Act, which mandates that BLM manage public land resources for a variety of uses, such as energy development, livestock grazing, recreation, and timber harvesting, while protecting the natural, cultural, and historical resources on those lands. The BLM manages listed and sensitive species under guidance provided in the BLM MS-6840 Manual—Special Status Species Management. The Manual directs BLM to proactively conserve species listed under the Act and the ecosystems upon which they depend, ensure that all actions authorized or carried out by BLM are in compliance with the Act, and cooperate with the planning and recovery of listed species. The BLM has experience in managing the black-footed ferret at four reintroduction sites in four States that occur at least in part on lands it manages, including Shirley Basin, Wyoming, and Wolf Creek, Colorado, which includes a small portion of Sweetwater County, Wyoming. Therefore, we anticipate appropriate management by BLM on any future ferret reintroduction sites that include BLM lands.

(2) National Forest Management Act of 1976, as amended (16 U.S.C. 1600 et seq.)—The National Forest Management Act instructs the USFS to strive to provide for a diversity of plant and animal communities when managing national forest lands. The USFS identifies species listed as endangered or threatened under the Act, including the black-footed ferret, as Category 1 species at risk based on rangewide and national imperilment. The USFS has experience in managing the black-footed ferret at one reintroduction site in South Dakota that occurs at least in part on USFS lands. Therefore, we anticipate appropriate management by the USFS on any future ferret reintroduction sites that include USFS lands.

(3) Wyoming State Law—The responsibilities of WGFD are defined in Wyoming Statute section 23-1-103, which instructs the WGFD to provide an adequate and flexible system for the control, management, protection, and regulation of all Wyoming wildlife. The Statute defines the black-footed ferret as a protected animal. The WGFD also defines the ferret as a “species of greatest conservation need” (Wyoming Game and Fish Department 2010, pp. IV-2-10-IV-2-13). This final rule has been developed in cooperation with the State to address any concerns and initiate additional ferret reintroductions in Wyoming. The WGFD has successfully managed the ferret at the Shirley Basin Reintroduction site since 1991. Therefore, we anticipate appropriate management by WGFD on any future ferret reintroduction sites in Wyoming.

Management issues related to the black-footed ferret Wyoming NEP area that have been considered include:

(a) Incidental Take: The regulations implementing the Act define “incidental take” as take that is incidental to, and not the purpose of, carrying out an otherwise lawful activity (50 CFR 17.3), such as agricultural activities and other rural development, and other activities that are in accordance with Federal, State, Tribal, and local laws and regulations. Experimental population rules contain specific prohibitions and exceptions regarding the taking of individual animals. Once this 10(j) rule becomes effective, incidental take of black-footed ferrets within the Wyoming NEP area will not be prohibited, provided that the take is unintentional and is in accordance with this 10(j) rule. However, if there is evidence of intentional take of this species within the NEP area that is not authorized by the 10(j) rule, we would refer the matter to the appropriate law enforcement entities for investigation.

(b) Special handling: In accordance with 50 CFR 17.21(c)(3), any employee or agent of the Service or of a State wildlife agency may in the course of their official duties, handle black-footed ferrets to aid sick or injured ferrets, or to salvage dead ferrets. Employees or agents of other Federal, Tribal, or State agencies would need to acquire the necessary permits from the Service for these activities.

(c) Coordination with landowners and land managers: This NEP designation under section 10(j) of the Act was discussed with potentially affected State and Federal agencies, Tribes, local governments, and other stakeholders within the expected reestablishment area. These agencies, landowners, and land managers have either indicated support for, or no opposition to, the establishment of future populations, provided an NEP is designated and a rule is promulgated to exempt incidental take from the section 9 take prohibitions. The Service and the WGFD will continue to coordinate to ensure local communities are fully engaged in any future black-footed ferret reintroduction efforts.

(d) Public awareness and cooperation: We informed the general public of the importance of this reintroduction project for the overall recovery of the black-footed ferret through the proposed rule and associated public meetings. We notified a comprehensive list of stakeholders of the meetings including affected Federal and State agencies, Tribal entities, local governments, landowners, nonprofit organizations, and other interested parties. The comments we received are listed in the final EA, were included in the formulation of alternatives considered in the NEPA process, and are considered in this final rule designating an NEP area for reintroduced black-footed ferrets in Wyoming. Designation of the NEP area will increase reintroduction opportunities and provide greater flexibility in management of the reintroduced ferret. The NEP designation is necessary to secure needed cooperation of the State, landowners, and other interests in the affected area.

(e) Potential impacts to other federally listed species: There are several federally listed, proposed (any species of fish, wildlife, or plant that is proposed in the Federal Register to be listed), and candidate (the Service has concluded that they should be proposed for listing) species in Wyoming. These species are identified in the following table.

Nearly all of the aforementioned species have habitat requirements such as forests, dunes, wetlands, or river systems that differ from the grassland prairie habitat requirements for the black-footed ferret. The only species that may be affected by reintroduction projects for the ferret in the Wyoming NEP area, other than the ferret, is the greater sage-grouse. At the time of the proposed 10(j) rule, the greater sage-grouse was a candidate species. Recently, the Service determined that the greater sage-grouse is no longer warranted for listing under the Act (80 FR 59858; October 2, 2015). The greater sage-grouse requires large, interconnected expanses of sagebrush (Connelly et al. 2004, p. 3-2; Stiver et al. 2006, p. I-2; Knick and Connelly 2011, p. 1). Habitat loss, degradation, and fragmentation are the primary stressors to the greater sage-grouse. A detailed description of the species' natural history, seasonal habitats, threats, and population trends can be found in the Service's recent 12-month not warranted finding (80 FR 59858; October 2, 2015). The ferret also requires large expanses of intact habitat, although it is dependent on prairie dogs, not sagebrush. However, some prairie dog habitat, particularly white-tailed prairie dog habitat, contains sagebrush.

Direct adverse effects to greater sage-grouse can occur from the application of zinc phosphide-based pesticides to manage expanding prairie dog colonies at reintroduction sites. Because the application of zinc phosphide will occur in July through February, greater sage-grouse (males, hens, and broods) may ingest zinc phosphide and become sickened or die. We determined that the issuance of this Federal rule to designate the black-footed ferret as a nonessential experimental population in the State of Wyoming in accordance with section 10(j) of the Act is not likely to jeopardize the continued existence of the greater sage-grouse based on the following: (1) The use of zinc phosphide is anticipated to be relatively rare at reintroduction sites, which minimizes exposure risk; (2) zinc phosphide can only be applied by a certified pesticide applicator, which minimizes misapplication and exposure risk to non-targeted species; and (3) there are approximately 43,000,000 acres of estimated greater sage-grouse habitat in Wyoming. To meet delisting guidelines in the Black-footed Ferret Recovery Plan, there must be 70,000 acres of prairie dog habitat. Thus, most greater sage-grouse habitat in Wyoming would not be impacted by the proposed action.

(f) Monitoring and Evaluation: Monitoring is a required element of all black-footed ferret reintroduction projects. The following types of monitoring will be conducted.

Reintroduction Effectiveness Monitoring: Partners will monitor population demographics and potential sources of mortality, including plague, annually for 5 years following the last release using spotlight surveys, snow tracking, other visual survey techniques, and possibly radio-telemetry of some individuals. Thereafter, demographic and genetic surveys will be completed periodically to track population status. Surveys will incorporate methods to monitor breeding success and long-term survival rates. In general, the Service anticipates that monitoring will be conducted by the lead for each reintroduction site, which in Wyoming will be the WGFD and participating partners. The WGFD will present monitoring results in their annual reports.

Donor Population Monitoring: Ferrets used for reintroduction will either be from the captive-breeding population or translocated from another viable reintroduction site. Ferrets in the captive-breeding population are managed and monitored in accordance with the Association of Zoos and Aquariums (AZA) Black-footed Ferret Species Survival Plan (SSP®). A breeding population of 280 animals will be maintained to provide a sustainable source of ferrets for reintroduction. The AZA SSP® Husbandry Manual provides up-to-date protocols for the care, propagation, preconditioning, and transportation of captive ferrets, and is used at all participating captive-breeding facilities. Ferrets may also be translocated from other reintroduction sites (which also originated from captive sources), provided their removal will not create adverse impacts upon the donor population and provided appropriate permits are issued in accordance with our regulations (50 CFR 17.22) prior to their removal. Population monitoring will be conducted at all donor sites.

Monitoring Impacts to Other Listed Species: We do not expect impacts to other federally listed species (see discussion under (e), above). The greater sage-grouse is the only species with habitat that might overlap with the black-footed ferret. However, we do not expect ferret reintroduction efforts to adversely impact greater sage-grouse for the reasons previously discussed. The WGFD conducts annual monitoring of the greater sage-grouse statewide. Additional monitoring will occur on non-federal lands enrolled in the Wyoming Candidate Conservation Agreement with Assurances for the greater sage-grouse and on Federal lands enrolled in the Wyoming Candidate Conservation Agreement for the greater sage-grouse.

In the proposed rule published on April 10, 2015 (80 FR 19263), we requested that all interested parties submit written comments on the proposal by June 9, 2015. We also contacted appropriate federal and state agencies, Tribes, scientific experts and organizations, and other interested parties and invited them to comment on the proposal.

During the public comment period on the proposed rule, we received a total of 29 comment letters addressing the proposed rule and several comments that were not relevant to the proposed rule. All substantive information provided during comment periods 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 three knowledgeable individuals with scientific expertise that included familiarity with the black-footed ferret and its habitat, biological needs, recovery efforts, and threats. We received responses from all three of the peer reviewers.

We reviewed all comments we received from the peer reviewers for substantive issues and new information regarding the establishment of a nonessential experimental population designation for black-footed ferret in the State of Wyoming. In general, the peer reviewers stated that the proposed rule provided an accurate summation of the best available scientific information on the biology, current status, and recovery efforts for black-footed ferret, and that the proposed establishment of an NEP area in Wyoming to facilitate black-footed ferret reintroduction is well supported by the best available scientific information. The peer reviewers generally 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 reviewer and several commenters were concerned with the statement in the proposed rule that the WGFD would have primary management responsibilities for ferret reintroduction in Wyoming. The reviewer stated that “[t]urning primary authority for management of a federally endangered species over to a state, even under 10(j), would be unprecedented as far as I can determine”.

Our Response: The Service will maintain authority for black-footed ferrets under the Act until the species is recovered and subsequently delisted. That said, as is true for nearly every endangered species recovery effort, recovery is a collaborative effort with success depending on the coordination and collaboration of a multitude of partners working towards a common goal. The WGFD is anticipated to play a lead role in recovery for the black-footed ferret in Wyoming under this 10(j) rule, likely conducting the actual on-the-ground ferret reintroduction and management work. This situation is in no way unprecedented, as on-the-ground reintroduction efforts under 10(j) are often managed by non-Service groups, including state agencies, non-governmental organizations, and Tribes. The Service considers participation by the WGFD invaluable to this recovery effort given their long history with black-footed ferret conservation and recovery, leadership in successful reintroductions in Shirley Basin (also under a 10(j) rule), intimate knowledge of local biological conditions, and familiarity with local landowners and other stakeholders.

This cooperative approach is consistent with our 2013 Memorandum Of Uderstanding (MOU), which committed the Service, the State of Wyoming, and other Federal partners (“Parties”) to work collaboratively to develop and implement the NEP area designation (WGFD and USFWS 2013). This MOU includes the following guiding principles, among others: (1) The Parties agree that they will collaboratively identify, and prioritize, prospective ferret reintroduction sites in Wyoming outside of the current 10(j) areas (i.e., Shirley Basin and Wolf Creek); and (2) the Parties agree that future reintroductions of the ferret will be based on mutually affirmed prioritization of prospective reintroduction sites (WGFD and USFWS 2013, pp. 5-6).

The Service will continue to play an active role in black-footed ferret recovery in Wyoming as outlined in the MOU and through the Service's oversight of the black-footed ferret allocation process. The Service determines, based on reintroduction proposals, which reintroduction sites receive captive born ferrets (i.e., kits) for release into the wild. Ferret allocation decisions made by the Service are based on the biological and scientific merit of the proposals, the suitability of proposed reintroduction sites, management capabilities of reintroduction programs, comprehensiveness of site work plans, the overall contribution to species recovery each project represents, and other considerations that may be unforeseen. Furthermore, the Service must be kept apprised of any post allocation changes in project design, direction, management, or field implementation of ferret reintroduction projects. No ferrets may be translocated, relocated, or removed from the wild (except for emergency health concerns) without prior Service notification and authorization.

(2) Comment: One peer reviewer stated that our determination of “nonessential” is misleading and erroneous, as it is was based on the conclusion that a loss of the proposed NEP in Wyoming will not appreciably reduce the likelihood of future survival of the ferret rangewide (i.e., at the 23 reintroduction sites outside of Wyoming). This reviewer further stated that “it is not whether the loss of a future population in Wyoming will affect the survival of another population somewhere else, but whether that population is intended to contribute to the recovery of the species.” Another peer reviewer and several commenters also questioned how all populations in Wyoming could be designated as nonessential despite the anticipated future “essential” role of such populations for the recovery of the species. In other words, some collection of reintroduction sites will necessarily comprise an “essential” part of the future recovered population.

Our Response: We agree with the contention that successfully reintroduced populations under this 10(j) rule will be a central part of black-footed ferret recovery. This is consistent with the Act's requirements for 10(j) experimental populations. Specifically, the Act requires that experimental populations further the conservation of the species. Conservation is defined by the Act as the use of all methods and procedures which are necessary to bring any endangered or threatened species to the point at which the measures provided pursuant to the Act are no longer necessary (16 U.S.C. 1532(3)). In short, experimental populations must further the species' recovery.

Under the revised Black-footed Ferret Recovery Plan, the species may be downlisted from endangered to threatened when at least 10 ferret populations, each with at least 30 breeding adults, are established. Thus, downlisting is based on biological parameters (e.g., number of breeding adults, number of successful sites). The recovery plan makes no distinction as to how these populations are designated once biological criteria are satisfied; each population will contribute toward recovery of the species whether it is designated as endangered, essential experimental, or nonessential experimental. The importance of future reintroduction sites to recovery, however, does not mean these populations are “essential” under section 10(j) of the Act. All reintroduction efforts are undertaken with the primary goal to move a species toward recovery. If importance to recovery was equated with essentiality, no reintroductions would qualify for nonessential status. This interpretation would conflict with Congress' expectation that “in most cases, experimental populations will not be essential” (H.R. Conference Report No. 835, supra at 34; USFWS 1984) and our 1984 implementing regulations, which indicated an essential population will be a special case and not the general rule (USFWS 1984).

(3) Comment: Two reviewers and one commenter expressed concern over the reliance of the black-footed ferret recovery program on the captive population. Selection acts on captive populations, potentially resulting in animals adapted for survival in captivity and maladapted for life in the wild.

Our Response: We agree that reliance on captive populations for species conservation is never ideal for numerous reasons, including those noted by the reviewers. Unfortunately, there are few alternatives for the black-footed ferret at this time. Thus, we recognize that it is vitally important for species persistence to expedite the establishment of reintroduction sites and wild populations whenever possible. For this reason, our recovery strategy emphasizes the rapid expansion of ferret recovery in the wild (USFWS 2013a, p. 68). Working in close coordination with the WGFD and other stakeholders, we fully expect establishment of additional wild populations in Wyoming under this 10(j) rule. An increase in successful reintroductions will result in a reduced reliance on the captive population in the future and allow for translocations of wild individuals to more fully support recovery efforts.

(4) Comment: One reviewer stated that due to a potential for genetic adaptation to the captive environment, the assumption by the Service that replacing wild animals with captive animals is equivalent to maintaining wild populations is biologically and legally flawed. The reviewer further stated that this assertion should be clarified and/or deleted entirely.

Our Response: Both in our proposal and this final rule, we state that animals lost during reintroduction efforts can be readily replaced through captive breeding, which produces juvenile ferrets in excess of the numbers needed to maintain the captive-breeding population. We do not make the assumption that replacement of wild animals with captive animals is equivalent to maintaining wild populations. It is always the Service's goal for reintroductions to be successful and contribute to recovery, which means the establishment of secure, self-sustaining populations in the wild. We recognize, however, that reintroductions are, by their nature, experiments whose outcome is uncertain. The point we are making with the above statement that “animals lost during reintroduction can be readily replaced through captive breeding” reflects the very real conservation status of the black-footed ferret; at this time, loss of the captive population could be catastrophic to the species, whereas the reverse is not true. The captive population of ferrets has been responsible for establishment of every wild ferret population in existence today, either wholly or primarily. Animals lost at reintroduction sites can be replaced by reintroduction of captive-bred individuals. We expect this trend will continue for the foreseeable future. Specifically, the captive population will remain important until establishment of the at least 30 wild populations needed for recovery is accomplished; both as a source of animals for reintroduction and as insurance against stochastic environmental events in wild populations (e.g., plague epizootics). Conversely, the populations in the Wyoming NEP can be established or re-established from the captive population. Thus, until the species is recovered, the Service considers the captive population to be far more important to the survival of the species in the wild than the planned Wyoming NEP. Whether the Wyoming NEP is essential to recovery of the species “in the wild” was discussed in more detail under Comment 2.

(5) Comment: One reviewer suggested that instead of giving reasons why the NEP is not “essential” the Service should indicate its intentions for the experimental population as follows: “Once the ferret population reaches its delisting goal this 10(j) rule will be mooted, as the species will no longer require protection of the [Act]. The FWS will then enter into post-delisting monitoring and management agreements with Wyoming to ensure adequate persistence of and protection for reintroduced populations of ferrets to ensure that ferrets are no longer subject to relisting under the [Act].”

Our Response: We are required under the Act to designate any experimental population as either “essential” or “nonessential.” Our nonessential determination is based on the best scientific and commercial data available and thus meets the requirements under the Act. This population satisfies all requirements for a 10(j) population and meets the standards for a nonessential population under this section of the Act. Although post-delisting management agreements are beyond the scope of this 10(j) rule, we do anticipate reintroductions authorized by this rule to advance the conservation of the species and that this progress may contribute to an eventual reclassification to threatened or full species recovery and delisting. Prior to delisting, it is likely we would pursue management agreements to provide us adequate confidence that recovery progress achieved will be maintained. This is consistent with the Black-footed Ferret Recovery Plan, which calls for the completion and implementation of a post-delisting monitoring and management plan, in cooperation with the states and Tribes, to ensure recovery goals are maintained (USFWS 2013a, p.6).

(6) Comment: Two reviewers and several commenters were concerned about the potential use of anticoagulant poisons like Rozol® to control prairie, dogs due to the potential for secondary toxicities to predators like black-footed ferrets. While they recognized that details on anticoagulant poison use may be more appropriately addressed in site-specific plans, they thought a framework for how the Service intends to approach this issue needed to be set out in this rule.

Our Response: Anticoagulant poisons can result in secondary impacts to any wildlife that consumes a poisoned prairie dog. In 2012, the Service completed formal consultation with the Environmental Protection Agency (EPA) to evaluate potential impacts to endangered and threatened species, including the black-footed ferret, from the use of the anticoagulant Rozol® to poison prairie dogs. Label restrictions resulting from this process prohibit application of Rozol® within current and future ferret recovery sites. It is a violation of Federal law to use a pesticide in a manner inconsistent with its labeling.

The Service would have no additional section 7 consultation role regarding the use of Rozol® at reintroduction sites in Wyoming, except in National Parks and National Wildlife Refuges. However, through the allocation process of providing captive ferrets to reintroduction sites, we determine which sites will receive ferrets. We do not support the use of Rozol® or other anticoagulants for control of prairie dogs, particularly at black-footed ferret reintroduction sites. Boundary control of prairie dogs at reintroduction sites is sometimes necessary because prairie dogs have encroached onto adjacent properties where prairie dogs are not wanted. If boundary control becomes necessary to maintain relations with neighboring landowners, we support the use of zinc phosphide in these instances. In comparison with Rozol®, which has a high risk of secondary poisoning of wildlife, zinc phosphide-based pesticides pose fewer risks to non-target wildlife when properly applied by a certified pesticide applicator as required by label.

(7) Comment: One reviewer expressed concern over WGFD management of future reintroductions, noting that WGFD has not consistently conducted annual monitoring for the Shirley Basin black-footed ferret population.

Our Response: Long-term wildlife management and monitoring programs seldom are able to achieve 100 percent success when it comes to meeting monitoring goals. Potential impediments to meeting monitoring goals include such things as changing staff workloads and turnover, budget limitations, inclement weather, and equipment failures, among many others. Overall, we believe that during the last 20 years, WGFD has demonstrated a meaningful commitment to black-footed ferret conservation in Shirley Basin through data reporting, multiple scientific publications on the black-footed ferret, plague management, and the release of over 500 ferrets into the area. Therefore, we are confident in their ability to manage future reintroduction efforts in Wyoming.

(8) Comment: One reviewer and several commenters requested we provide a specific timeline for completion of the identification and evaluation of reintroduction sites.

Our Response: Stakeholders in Wyoming essentially viewed the implementation of a Statewide 10(j) rule as a prerequisite to participation in any ferret recovery actions in the State of Wyoming. Thus, implementation of this rule is only a first step in advancing black-footed ferret recovery in Wyoming. Under the 2013 MOU guiding principles, the WGFD and the Service will collaboratively identify and prioritize prospective reintroduction sites in the Wyoming NEP area. The steps that must be taken before a site can receive ferrets are substantial and calculated with the goal of selecting sites with the best potential of success. Steps include, but are not limited to: (1) Identification of interested and willing landowners; (2) biological evaluation of each site's potential to support at least 30 ferrets; and (3) creation of site-specific management plans (see Location of the Nonessential Experimental Population Area). At this time we do not have precise information on locations of all suitable habitat, nor have any prospective reintroduction sites been approved yet for allocation of captive-bred ferrets. Therefore, we believe reporting a specific timeline would be arbitrary and premature.

Implementation of this Statewide 10(j) rule will significantly reduce the administrative burden that would have been associated with development of multiple site-specific rules. In this case, the WGFD is not precluded from coordinating simultaneously with multiple landowners and evaluating sites for potential reintroduction. We believe under this Statewide 10(j) rule, the process for black-footed ferret reintroductions in Wyoming will be effectively streamlined. Encouragingly, following publication of the proposed rule in the Federal Register, WGFD has reported that a number of landowners have approached them expressing interest in establishing a ferret population on their land following implementation of the 10(j) rule.

(9) Comment: One reviewer and several commenters wanted greater detail on specific reintroduction and sylvatic plague management plans.

Our Response: Many of the specific questions raised in the comments are answered under Release Procedures, above. Development of management plans for reintroductions and sylvatic plague are a cooperative effort between the Service, WGFD, other federal agencies, landowners, and affected stakeholders. Final plans must be approved by the Service as part of the ferret allocation process. Ferret allocation decisions are based on the considerations mentioned in our response to Comment 1. We expect that future site-specific management plans will have many similarities to past plans for other reintroduction sites.

(10) Comment: One reviewer and several commenters wondered if the public would have an opportunity to comment on potential reintroduction sites in the future.

Our Response: There is no formal public comment period for potential reintroduction sites or site-specific management plans, but there will be opportunities for public involvement. The Service and the WGFD recognize that local involvement is important to the success of recovery efforts and the long-term conservation of the black-footed ferret in Wyoming. Consequently, as required in the 2013 MOU, the Service and WGFD will coordinate to ensure local communities, including potentially affected landowners, stakeholder groups, local governments, and Tribes are fully engaged in any future black-footed ferret reintroduction efforts. Future management plans may contain provisions similar to the following, although the specific content and details will vary by reintroduction site. Public involvement may include but is not limited to the following: (1) Public meetings to outreach to all interested parties on determining potential reintroduction sites; (2) Coordination with all interested parties after a reintroduction site is determined; (3) Direct involvement of management plan development which could include state and federal agencies, County Commissioners, landowners, companies, academia, and other stakeholders, and tribes; (4) Allowing landowners and land managers the opportunity to cooperatively decide the number and distribution of prairie dogs (and correspondingly black-footed ferrets) that may occur on privately owned and leased lands; (5) Annually obtaining landowner approval of human activity necessary for actions specified in a plan; (6) Biannual review of the progress of ongoing activities by all concerned parties; (7) Direct involvement any interested parties in monitoring activities on reintroduction sites.

(11) Comment: Two reviewers questioned whether the estimates for the number of black-footed ferrets currently in the wild were the most current estimates available.

Our Response: As is true for many species, and particularly with one that is largely fossorial (i.e., lives mostly underground) and nocturnal like the black-footed ferret, determining precise population numbers is challenging. Black-footed ferret populations are difficult to count due to their remote locations, difficult accessibility, nocturnal habits, small population sizes, and logistical problems and costs associated with the requisite field work. More importantly, ferret populations can also fluctuate significantly from one year to the next depending on the presence or absence of plague and active plague management, or due to other environmental factors like drought. Accordingly, a tally of adult ferret numbers at any one point in time is likely a poor indicator of recovery progress. We view ferret population estimates at most sites as minimum numbers because of the aforementioned issues.

We stated in the EA and proposed rule that there are approximately 418 breeding adult ferrets in the wild, including approximately 102 breeding adults in the reintroduced population at Shirley Basin, Wyoming, as was reported in the 2013 Black-footed Ferret Recovery Plan (USFWS 2013a, Table 2). The reviewers are correct that the value for Shirley Basin is an estimate derived from surveys conducted in 2010. A more recent report gives the same estimate of approximately 100 breeding adults in Shirley Basin based on the 2010 survey and approximately 295 breeding adults rangewide (Black-footed ferret Recovery and Implementation Team Conservation Subcommittee Report 2014, Table 1). The current Shirley Basin estimate is based on the best available science and is meant to provide the most accurate assessment of the magnitude of the population size rather than the precise number of individuals, which can fluctuate considerably for the reasons given above.

(12) Comment: One reviewer questioned the meaning of the phrase “occupied prairie dog habitat,” noting that one could ask “occupied by what?”

Our Response: When we use the phrase “occupied prairie dog habitat,” we mean areas that are occupied by prairie dogs. A review of the scientific literature on prairie dogs shows both “occupied prairie dog habitat” and “prairie dog occupied habitat” are commonly used terms to indicate habitat that is occupied by prairie dogs. While we agree with the comment in general as prairie dog colonies can and typically are “occupied” by a number of other species, in this case we believe, however, it is clear by the context that what is being referenced in this rule is occupancy by prairie dogs.

(13) Comment: One reviewer questioned the criteria for evaluating potential reintroduction sites. The reviewer stated that occupancy of habitat by prairie dogs is a simplistic criterion considering prairie dog populations can fluctuate significantly over time, expanding and contracting for a number of reasons, including plague.

Our Response: Determining occupancy by prairie dogs is simply a first step in determining the potential for reintroduction site. A large number of other factors are considered for determining the suitability of proposed reintroduction sites. Foremost in consideration for prioritizing black-footed ferret allocations (i.e., young ferrets available for release into the wild) is the size, density, health, and overall stability of potential ferret habitat. Additional non-biological requirements for ferret allocations include a willing landowner and a management plan that addresses sylvatic plague.

(14) Comment: One reviewer agreed with our identification of plague as a major impediment to the recovery of black-footed ferret, but noted that the management of plague only “during periodic outbreaks of sylvatic plague” understates the problem. Recent research has shown that plague has serious negative effects on prairie dog populations not only during major “outbreaks” but also when present at lower levels.

Our Response: Currently, management for sylvatic plague is carried out largely by dusting the impacted area with pesticides meant to kill the fleas that host the plague bacteria. This type of management can be effective. We agree, however, that this approach is not ideal, as it is typically only applied after plague has been detected, which is often too late, as mortality of ferrets and prairie dogs has already been significant. A new oral vaccine, currently being field tested, could provide a more effective, less expensive way to protect prairie dogs.

The Service recognizes that understanding how to control or preferably eradicate sylvatic plague is critical to black-footed ferret conservation. The complex dynamics of sylvatic plague are not fully understood. As scientific knowledge of sylvatic plague advances, that information will be incorporated into management plans that address sylvatic plague. Although research projects are not required program elements for ferret allocations to reintroduction sites, the Service encourages, supports, and may give greater priority to projects that incorporate research elements addressing specific ferret recovery problems or questions.

(15) Comment: One reviewer wanted to see affirmation that the Wind River Tribes concur with the application of 10(j) to tribal lands within the Wind River Indian Reservation. The reviewer stated that Tribes may have an interest in maintaining full protection for ferrets within their boundaries.

Our Response: We contacted the Eastern Shoshone and Northern Arapaho Tribes of the Wind River Indian Reservation and invited them to comment on the proposal. We did not receive comments from either Tribe. It is unlikely that these two Tribes have adequate prairie dog occupied habitat that would be suitable for a future reintroduction of the black-footed ferret. This does not preclude coordination with the Tribes in the future if circumstances change.

(16) Comment: The State of Wyoming and several commenters were concerned that the Service could change the NEP designation to experimental essential, endangered, or threatened in the future. The Service should clarify under what conditions a change in designation could occur.

Our Response: We do not foresee the need to change the NEP designation for any reintroduced black-footed ferret population. One of the benefits of an NEP designation is that it provides flexibility in the regulatory requirements in the area where the reintroduction occurs. This regulatory relief is important because, prior to reintroduction, these sites had no regulation related to the subject species because the species was not present. Thus, State, tribal, and private landowners typically resist endangered species reintroductions that bring with them new Federal regulation. This resistance can be nearly insurmountable. Fewer black-footed ferret reintroductions would have been initiated during the past 20 years without the added flexibility of nonessential experimental designations. To date, 11 black-footed ferret reintroductions have occurred through use of section 10(j) designated NEP areas in the United States, including in the Shirley Basin in Wyoming (USFWS 2013a, pp. 38-39). We do not believe ferrets would likely exist today in Wyoming if not for their nonessential experimental designation in Shirley Basin and the resulting reduced regulatory burden.

All determinations on essentiality are made prior to any reintroduction action being taken. It is instructive that Congress did not put requirements in section 10(j) to reevaluate the classification after a reintroduction has occurred. While our regulations require a “periodic review and evaluation of the success or failure of the release and the effect of the release on the conservation and recovery of the species” (50 CFR 17.81(c)(4)), this has not been interpreted as requiring reevaluation and reconsideration of sites' nonessential experimental status (USFWS 1991, 1994, and 1996). We believe Congressional intent was to ensure that our partners could rely upon the original rules promulgated for the reintroduction effort. We also contend that retracting the nonessential experimental designation following implementation of this 10(j) rule would be extremely detrimental to ferrets in Wyoming and the partnerships that sustain them. Furthermore, such an alteration of the regulatory framework post-reintroduction would undermine future reintroduction efforts.

Typically, endangered species recovery efforts, including those for ferrets, depend on a myriad of partners working together to accomplish a common goal. In most cases, and particularly for ferrets, recovery would not be possible without substantial partner efforts. In looking back on ferret recovery over the last 25 years, we have gone from no ferret populations known in the wild to having 24 ferret reintroduction sites in the wild, with 17 of those sites continuing to have ferrets through 2015. Hundreds of partners have made this possible. We believe these are not trivial accomplishments. At nearly all the 24 ferret reintroduction sites, it is our partners who accomplish the actual on-the-ground ferret reintroduction and management work. The same will be true in this case, with WGFD taking the lead on implementation of reintroductions. Absent those partnerships, there would be far fewer reintroductions and likely no ferrets in Wyoming. Accordingly, the Service highly values those local partnerships that accomplish ferret recovery and is understandably cautious about undertaking actions that disrupt those partnerships.

In 2009, the Service received a petition to reclassify three reintroduced black-footed ferret populations from nonessential experimental to endangered, including the Shirley Basin NEP in Wyoming. This petition was submitted pursuant to section 553 of the Administrative Procedure Act (5 U.S.C. 553) (WildEarth Guardians et al. 2009). The Service strongly believed and continues to believe that the ramifications of such an action would be detrimental to ferrets at these sites and the partnerships that sustain them. As we anticipated, the petition had immediate negative impacts to ferret recovery, prompting landowners to withdraw support for another planned reintroduction in Wyoming. The Service denied the petition in 2010 (USFWS 2010).

As mentioned above, we do not foresee the need to change the NEP designation for any wild black-footed ferret population. The captive population is crucial to survival of the species in the wild at this time, and likely for the foreseeable future. However, a substantial loss of the captive population is highly improbable, as captive ferrets have been purposefully dispersed among six facilities, protecting the species from a single catastrophic event. In any circumstance, any change in the 10(j) listing would require a new proposed rule, a public comment period (including, if requested, public hearings), public meetings, NEPA compliance, and other documentation prior to publication of a final rule to change or abandon the NEP designation.

(17) Comment: The State of Wyoming and several commenters requested that the Service provide assurance that if the 10(j) designation changed in any respect, the Service would remove the ferrets.

Our Response: Under 50 CFR 17.84(g)(12), the following will apply to any reintroduced ferret populations under this 10(j) rule:

(18) Comment: The State of Wyoming requested assurance from the Service that there will be thorough and appropriate consultation before any ferrets are brought into Wyoming under this rule.

Our Response: We fully expect that all reintroductions efforts under this 10(j) rule will be conducted in close coordination with the WGFD, landowners, and affected stakeholders. This coordination will take place under previsions in the 2013 MOU and as part of the ferret allocation process.

(19) Comment: Two commenters stated that the Service's current prairie dog range estimate is not based on the best available science and information. Specifically the commenters point out that the Service claims there to be nearly 3.1 million acres of prairie dog occupied habitat in Wyoming, but previously (in USFWS 2009) has stated that the prairie dog occupies 2.4 million acres across its entire range.

Our Response: It is important to clarify that the 2.4 million acres of occupied habitat estimated in USFWS 2009 is a rangewide estimate for black-tailed prairie dogs (one of four species of prairie dog) only. Our estimate in the proposed rule and above of the amount of prairie dog occupied habitat in Wyoming includes estimates for both species of prairie dog that occur in Wyoming. We cite recent estimates of prairie dog occupied habitat in Wyoming at 2,893,487 ac (1,171,862 ha) in the white-tailed prairie dog range and 229,607 ac (92,991 ha) in the black-tailed prairie dog range (Van Pelt 2013, pp. 8, 14). Black-tailed prairie dogs have a much smaller estimated range in the State of Wyoming while the estimated white-tailed prairie dog habitat in Wyoming is much larger. The combined estimate for both species of prairie dog in Wyoming is based on the best available scientific information.

(20) Comment: Two commenters noted that aerial surveys overestimate occupied prairie dog habitat by as much as 94 percent (Sidle et al. 2012). One commenter stated that if the estimate of prairie dog habitat is inaccurate then the area to which black-footed ferrets may be introduced is exaggerated. The commenter also alleged that the Service has used inaccurate data to formulate population goals of both the black-footed ferret and black tailed prairie dogs.

Our Response: We acknowledge that aerial surveys can overestimate the extent of active or occupied prairie dog habitat and that there is some degree of error attached to any such estimate. Overestimates of prairie dog colonies result because observers may have difficulty distinguishing active, occupied burrows from unoccupied burrows from the air. Researchers continue working to refine methods for accurately assessing active prairie dog populations from the air.

It is important to note, however, that in the case of black-footed ferret reintroductions, aerial surveys are used only as a rough guide for identifying potential black-footed ferret habitat for reintroductions. Measurable fluctuations in prairie dog occupancy are a part of the natural dynamics of prairie dog populations, but fluctuations can be especially pronounced in areas experiencing plague or subjected to poisoning. The presence of unoccupied burrows conclusively indicates that prairie dogs occupied the area sometime in the recent past. Thus, while we may use aerial surveys as rough estimate of prairie dog habitat, we do not rely on aerial surveys to identify areas with the highest biological potential for black-footed ferret reintroductions. Reintroduction sites are chosen instead based on a number of other factors including the size, density, health, and overall stability of the prairie dog occupied habitat, information that is gathered from ground surveys and local knowledge of prairie dog colonies in a given area.

States are encouraged to contribute to recovery goals in proportion to the amount of historical ferret habitat (i.e., prairie dog colonies) that once occurred on these lands. The Black-footed Ferret Recovery Plan estimates that 35,000 ac (14,000 ha) of purposefully managed prairie dog occupied habitat will be needed to meet Wyoming's portion of the rangewide habitat goal for downlisting and 70,000 ac (28,000 ha) to meet their portion of the rangewide habitat goal for delisting (USFWS 2013a, Table 8). For the State of Wyoming, this equates to purposeful management of approximately 2 percent of the estimated prairie dog habitat in Wyoming to meet their portion of the rangewide habitat goals for delisting. The best available science supports our estimates of occupied prairie dog habitat and potentially suitable habitat for black-footed ferret reintroductions.

(21) Comment: Several commenters were concerned with potential impacts of black-footed ferret reintroductions on federal oil and gas lessees. They asserted that because federal oil and gas leases are interests in real property, the holder of a federal oil and gas lease is no different than a private surface owner.

Our Response: We concluded in the proposed rule and the EA that the most prevalent land use activities, including energy development, currently occurring in the NEP area are compatible with ferret recovery and that there is no information to suggest that future activities would be incompatible with ferret recovery. Federal oil and gas leases will certainly be considered and lessees likely consulted during development of reintroduction proposals for the ferret allocation process. Current and future land management, principal land uses, and potential for change or land management conflicts are serious considerations for all potential reintroduction sites. Reintroduction allocation decisions are made based on a potential reintroduction site's probability for long-term success. We have little interest in allocating ferrets, an exceptionally limited resource, to areas where land management conflicts will be an obvious problem, either currently or in the future.

(22) Comment: One commenter stated that black-footed ferrets are believed to be predators of sage-grouse nests and therefore will have negative impacts on sage-grouse.

Our Response: Based on our extensive experience with both species in the wild and our review of the scientific literature, we are not aware of any evidence that black-footed ferrets are predators on sage-grouse at any life stage, including nests (eggs), adults, or chicks. Black-footed ferrets depend almost exclusively on prairie dogs for food.

In our proposed rule, the language under paragraph (g)(9)(viii) stated that “Any black-footed ferret found within the Wyoming Experimental Population Area will be considered part of the nonessential experimental population after the first breeding season following the first year of black-footed ferret release. A black-footed ferret occurring outside of the State of Wyoming would initially be considered as endangered, but may be captured for genetic testing.”

As noted by one reviewer, this language was included in earlier 10(j) rules at a time when the discovery of other extant wild ferret populations was still considered plausible. There have been no verified reports of any extant black-footed ferret individuals or populations in any prairie dog complex since the discovery of the last known wild black-footed ferret population near Meeteetse, Wyoming, in 1981. Recently, the Service issued a `block clearance' letter for the ferret in the State of Wyoming (Service 2013c). Block clearance provides an acknowledgement that the likelihood of identifying ferrets in Wyoming, outside of those resulting from reintroductions, is distinctly minimal. Our revision of paragraph (g)(9)(viii) reflects this determination. Thus, once this 10(j) rule becomes effective, any black-footed ferret found within the Wyoming NEP Experimental Population Area will be considered part of the nonessential experimental population. A black-footed ferret that disperses beyond the boundaries of the nonessential experimental population takes on the status of that area (endangered, unless within another nonessential experimental population area).

We followed the procedures required by the Act, NEPA, and the Administrative Procedure Act during this Federal rulemaking process. We solicited public comment on the proposed NEP designation. We have considered all comments we received on the proposed rule and the draft EA before making this final determination. Based on the above information, and using the best scientific and commercial data available (in accordance with 50 CFR 17.81), we find that establishing this Wyoming NEP area will further conservation of the species, but that any future experimental populations of black-footed ferrets in Wyoming would not be essential to the continued existence of the species in the wild.

Therefore, we are finalizing our proposal to designate most of Wyoming (the remainder of the State of Wyoming not covered under past NEPs) as an NEP area under section 10(j) of Act. The result of this designation and the two previous designations is that all black-footed ferrets found within the entire State of Wyoming are considered as an NEP. Black-footed ferrets will be managed under the associated NEP regulations, allowing greater management flexibility. We anticipate this will encourage partners to undertake new reintroductions, advancing the conservation and recovery of the species.

Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is not significant.

Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.

Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 801 et seq.), whenever a Federal agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare, and make available for public comment, a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e., small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. We certify that this rule will not have a significant economic effect on a substantial number of small entities. The following discussion explains our rationale.

The area that will be affected by this rule includes release sites in Wyoming and adjacent areas in Wyoming into which black-footed ferrets may disperse. Because of the regulatory flexibility for Federal agency actions provided by the NEP designation and the exemption for incidental take in the 10(j) rule, we do not expect this rule to have significant effects on any activities within Federal, State, or private lands within the NEP. When NEPs are located outside a National Wildlife Refuge or National Park Service unit, then, for the purposes of section 7, we treat the population as proposed for listing and only section 7(a)(1) and section 7(a)(4) apply. In these instances, NEPs provide additional flexibility because Federal agencies are not required to consult with us under section 7(a)(2). Section 7(a)(4) requires Federal agencies to confer (rather than consult) with the Service on actions that are likely to jeopardize the continued existence of a species proposed to be listed. However, because the NEP is, by definition, not essential to the survival of the species, conferring will likely never be required for the black-footed ferret populations within the NEP area. Furthermore, the results of a conference are advisory in nature and do not restrict agencies from carrying out, funding, or authorizing activities. In addition, section 7(a)(1) requires Federal agencies to use their authorities to carry out programs to further the conservation of listed species, which would apply on any lands within the NEP area. As a result, and in accordance with these regulations, some modifications to proposed Federal actions within the NEP area may occur to benefit the black-footed ferret, but we do not expect projects to be halted or substantially modified as a result of these regulations.

This 10(j) rule will broadly authorize incidental take of the black-footed ferret within the NEP area. The regulations implementing the Act define “incidental take” as take that is incidental to, and not the purpose of, the carrying out of an otherwise lawful activity such as, agricultural activities and other rural development, camping, hiking, hunting, vehicle use of roads and highways, and other activities in the NEP area that are in accordance with Federal, Tribal, State, and local laws and regulations. Intentional take for purposes other than authorized data collection or recovery purposes would not be permitted. Intentional take for research or recovery purposes would require a section 10(a)(1)(A) recovery permit under the Act.

The principal activities on private property in the NEP area are livestock grazing and associated ranch management practices (e.g., fencing, weed treatments). We believe the presence of the black-footed ferret would not affect the use of lands for these purposes because there would be no new or additional economic or regulatory restrictions imposed upon states, non-federal entities, or members of the public due to the presence of the black-footed ferret, and federal agencies would only have to comply with sections 7(a)(1) and 7(a)(4) of the Act in these areas. Therefore, this rulemaking is not expected to have any significant adverse impacts to activities on private lands within the NEP area.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.):

(1) This rule will not “significantly or uniquely” affect small governments. We have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502 et seq., that this rulemaking will not impose a cost of $100 million or more in any given year on local or state governments or private entities. A Small Government Agency Plan is not required. Small governments will not be affected because the NEP designation does not place additional requirements on any city, county, or other local municipalities.

(2) This rule will not produce a Federal mandate of $100 million or greater in any year (i.e., it is not a “significant regulatory action” under the Unfunded Mandates Reform Act). This NEP designation for the black-footed ferret will not impose any additional management or protection requirements on the States or other entities.

In accordance with Executive Order 12630, this final rule does not have significant takings implications. This rule allows for the take of reintroduced black-footed ferret when such take is incidental to an otherwise legal activity, such as recreation (e.g., hiking, hunting, fishing, bird watching), forestry, agriculture, and other activities that are in accordance with Federal, State, and local laws and regulations. Therefore, we do not believe that establishment of this NEP will conflict with existing or proposed human activities or hinder public use of ferret habitat in Wyoming.

A takings implication assessment is not required because this rule: (1) Will not effectively compel a property owner to suffer a physical invasion of property, and (2) will not deny any economically beneficial or productive use of the land or aquatic resources. This rule will substantially advance a legitimate public interest (conservation and recovery of a listed species) and will not present a barrier to all reasonable and expected beneficial use of private property.

In accordance with Executive Order 13132 (70 FR 23775), we have considered whether this final rule has significant Federalism effects and have determined that a federalism summary impact statement is not required. This rule will not have substantial direct effects on the states, on the relationship between the Federal government and the states, or on the distribution of power and responsibilities among the various levels of government. In keeping with Department of the Interior policy, we requested information from and coordinated development of this final rule with the affected resource agencies in Wyoming. Achieving the recovery goals for this species will contribute to its eventual delisting and return to state management. No intrusion on state policy or administration is expected, roles or responsibilities of Federal or State governments will not change, and fiscal capacity will not be substantially directly affected. The final 10(j) rule operates to maintain the existing relationship between the State and the Federal governments and is being undertaken in coordination with the State of Wyoming. We have cooperated with WGFD in the preparation of this final rule. Therefore, this final rule does not have significant Federalism effects or implications to warrant the preparation of a federalism summary impact statement pursuant to the provisions of Executive Order 13132.

In accordance with Executive Order 12988, the Office of the Solicitor has determined that this rule does not unduly burden the judicial system and meets the requirements of sections (3)(a) and (3)(b)(2) of the Order.

Office of Management and Budget (OMB) regulations at 5 CFR 1320, which implement provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), require that Federal agencies obtain OMB approval before collecting information from the public. This final rule does not include any new collections of information that require OMB approval under the Paperwork Reduction Act. OMB has approved our collection of information associated with reporting the taking of experimental populations (50 CFR 17.84) and assigned OMB Control Number 1018-0095, which expires on October 31, 2017. We may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

In compliance with all provisions of the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 et seq.), we have analyzed the impact of this rule. Based on this analysis and information resulting from public comment on the proposed action, we determined that this action will not have significant impacts or effects. We have prepared a final EA and finding of no significant impact on this action, which are available for public inspection: (1) In person at the Wyoming Ecological Services Field Office (see ADDRESSES) and (2) online at http://www.regulations.gov. All appropriate NEPA documents were finalized before this rule was finalized.

In accordance with the presidential memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 229511), Executive Order 13175 (65 FR 67249), and the Department of the Interior Manual Chapter 512 DM 2, we have considered possible effects on federally recognized Indian Tribes and have determined that Tribal lands overlap the Wyoming NEP in portions of Fremont and Hot Springs Counties. However, participation in black-footed ferret recovery is entirely voluntary. If suitable habitat for ferret recovery is available, non-Federal landowners, including Tribes, may choose to either not participate, or to participate through authorities under 10(j), 10(a)(1)(A), or the Safe Harbor Agreement (USFWS 2013b). If ferrets were reintroduced on non-tribal lands adjacent to Tribal lands and subsequently dispersed onto Tribal lands, the aforementioned authorities will provide a more relaxed regulatory situation under the Act through allowances for incidental take. However, as stated previously, we are not aware of any prairie dog complexes suitable for ferret reintroduction on or adjacent to Tribal lands. The nearest potential reintroduction sites are two white-tailed prairie dog complexes—Fifteen-mile Complex near Worland in Hot Springs County, and Sweetwater Complex near Sweetwater Station in Fremont County (Luce 2008, pp. 29-30). Both sites are of intermediate potential for ferret reintroduction and are located approximately 19 miles (30 kilometers) from reservation boundaries. We sent letters, describing our proposed action and requesting input, to the Northern Arapaho and Eastern Shoshone Tribes of the Wind River Reservation on September 4, 2014. We did not receive a response from either Tribe.

Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This rule is not expected to significantly affect energy supplies, distribution, or use. Therefore, this action is not a significant energy action, and no Statement of Energy Effects is required.

A complete list of all references cited in this rule is available on the Internet at http://www.regulations.gov at Docket No. FWS-R6-ES-2015-0013, or upon request from the Wyoming Ecological Services Field Office (see ADDRESSES).

The authors of this final rule are staff members of the Wyoming Ecological Services Field Office (see ADDRESSES).

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

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

The 2015 rock sole and yellowfin sole CDQ reserves specified in the BSAI are 6,875 metric tons (mt) and 17,321 mt as established by the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015) and following revisions (80 FR 65663, October 27, 2015). The 2015 rock sole, and yellowfin sole CDQ ABC reserves are 12,567 mt and 9,301 mt as established by the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015) and following revisions (80 FR 65663, October 27, 2015).

The Bristol Bay Economic Development Corporation has requested that NMFS exchange 600 mt of rock sole CDQ reserves for 600 mt of yellowfin sole CDQ ABC reserves under § 679.31(d). Therefore, in accordance with § 679.31(d), NMFS exchanges 600 mt of rock sole CDQ reserves for 600 mt of yellowfin sole CDQ ABC reserves in the BSAI. This action also decreases and increases the TACs and CDQ ABC reserves by the corresponding amounts. Tables 11 and 13 of the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015) and following revisions (80 FR 65663, October 27, 2015) are further revised as follows: