The proposed rule was published in the November 22, 2006 Federal Register for a public comment period to end on January 22, 2007. Copies of the proposed rule also were posted on the Board's Web site and on the Federal Rulemaking Portal. This rule sets forth the procedures to be used by members of the public when requesting records from the Board under the Privacy Act of 1974. It also establishes time frames for responses from the Board, a fee schedule for copying records, and charges for obtaining information, when applicable. No comments were received on the proposed rule.

The proposed regulation does not meet the criteria for a significant regulatory action under Executive order 12866. Therefore, review by the Office of Management and Budget is not required.

The proposed rule adds Privacy Act regulations to 10 CFR part 1304 and will not have a significant economic impact on a substantial number of small entities.

The rule is exempt from the requirements of the Paperwork Reduction Act.

On June 4, 2002, Dassault Aviation, 9 rond Point des Champs Elysées, 75008, Paris, France, applied for a type certificate for its new Model Falcon 7X airplane. The Model Falcon 7X is a 19 passenger transport category airplane, powered by three aft mounted Pratt & Whitney PW307A high bypass ratio turbofan engines. The airplane is operated using a fly-by-wire (FBW) primary flight control system. This will be the first application of a FBW primary flight control system in an airplane primarily intended for private/corporate use.

The Dassault Aviation Model Falcon 7X design incorporates equipment that was not envisioned when part 25 was created. This equipment affects the interaction of systems and structures, limit pilot forces, and high intensity radiated fields (HIRF) protection. Therefore, special conditions are required to provide the level of safety equivalent to that established by the regulations.

Under the provisions of 14 CFR 21.17, Dassault Aviation must show that the Model Falcon 7X airplane meets the applicable provisions of part 25, as amended by Amendments 25-1 through 25-108.

If the Administrator finds that the applicable airworthiness regulations ( i.e. , 14 CFR part 25) do not contain adequate or appropriate safety standards for the Model Falcon 7X 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 Model Falcon 7X 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.

The FAA issues special conditions, as defined in § 11.19, are issued under § 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 Model Falcon 7X airplane will incorporate the following novel or unusual design features: interaction of systems and structures, limit pilot forces, and electrical and electronic flight control systems. These special conditions address equipment which may affect the airplane's structural performance, either directly or as a result of failure or malfunction; pilot limit forces; and electrical and electronic systems which perform critical functions that may be vulnerable to HIRF.

These special conditions are identical or nearly identical to those previously required for type certification of other Dassault airplane models. In general, the special conditions were derived initially from standardized requirements developed by the Aviation Rulemaking Advisory Committee (ARAC), comprised of representatives of the FAA, Europe's Joint Aviation Authorities (now replaced by the European Aviation Safety Agency), and industry.

Additional special conditions will be issued for other novel or unusual design features of the Dassault Model Falcon 7X airplane. These additional proposed special conditions will pertain to the following topics:

Final special conditions have been issued for the Model Falcon 7X pertaining to Pilot Compartment View—Hydrophobic Coatings in Lieu of Windshield Wipers January 10, 2007 (72 FR 1135).

Notice of proposed special conditions no. 26-06-10-SC for Dassault Aviation Model Falcon 7X airplanes was published in the Federal Register on October 18, 2006 (FR 71 61427). No comments were received, and the special conditions are adopted as proposed.

Because of these rapid improvements in airplane technology, the applicable airworthiness regulations do not contain adequate or appropriate safety standards for these design features. Therefore, in addition to the requirements of part 25, subparts C and D, the following three special conditions apply.

The Dassault Model Falcon 7X is equipped with systems that may affect the airplane's structural performance either directly or as a result of failure or malfunction. The effects of these systems on structural performance must be considered in the certification analysis. This analysis must include consideration of normal operation and of failure conditions with required structural strength levels related to the probability of occurrence.

Previously, special conditions have been specified to require consideration of the effects of systems on structures. The special condition for the Model Falcon 7X is nearly identical to that issued for other fly-by-wire airplanes.

Like some other certificated transport category airplane models, the Dassault Model Falcon 7X airplane is equipped with a side stick controller instead of a conventional wheel or control stick. This kind of controller is designed to be operated using only one hand. The requirement of § 25.397(c), which defines limit pilot forces and torques for conventional wheel or stick controls, is not appropriate for a side stick controller. Therefore, a special condition is necessary to specify the appropriate loading conditions for this kind of controller.

The Dassault Model Falcon X will utilize electrical and electronic systems which perform critical functions. These systems may be vulnerable to HIRF external to the airplane. There is no specific regulation that addresses requirements for protection of electrical and electronic systems from HIRF. With the trend toward increased power levels from ground-based transmitters and the advent of space and satellite communications, coupled with electronic command and control of the airplane, the immunity of critical avionics/electronics and electrical systems to HIRF must be established.

To ensure that a level of safety is achieved that is equivalent to that intended by the regulations incorporated by reference, a special condition is needed for the Dassault Model Falcon 7X airplane. This special condition requires that avionics/electronics and electrical systems that perform critical functions be designed and installed to preclude component damage and interruption.

It is not possible to precisely define the HIRF to which the airplane will be exposed in service. There is also uncertainty concerning the effectiveness of airframe shielding for HIRF. Furthermore, coupling of electromagnetic energy to cockpit-installed equipment through the cockpit window apertures is undefined. Based on surveys and analysis of existing HIRF emitters, adequate protection from HIRF exists when there is compliance with either paragraph 1 OR 2 below:

1. A minimum threat of 100 volts rms (root-mean-square) per meter electric field strength from 10 KHz to 18 GHz.

a. The threat must be applied to the system elements and their associated wiring harnesses without the benefit of airframe shielding.

b. Demonstration of this level of protection is established through system tests and analysis.

2. A threat external to the airframe of the field strengths indicated in the table below for the frequency ranges indicated. Both peak and average field strength components from the table are to be demonstrated.

The threat levels identified above are the result of an FAA review of existing studies on the subject of HIRF, in light of the ongoing work of the Electromagnetic Effects Harmonization Working Group of the Aviation Rulemaking Advisory Committee.

As discussed above, these special conditions are applicable to the Dassault Model Falcon 7X. Should Dassault Aviation apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

This action affects only certain novel or unusual design features of the Dassault Model Falcon 7X airplane. It is not a rule of general applicability.

Sections 234 and 235 of the James W. Nance and Meg Donovan Foreign Relations Authorization Act, Fiscal Years 2000 and 2001 (Pub. L. 106-113), (hereinafter “the Act”), as codified in 22 U.S.C. 2715b and 2715c.

The Department published a proposed rule, Public Notice 5582 at 71 FR 62219, on October 24, 2006, with a request for comments regarding the proposed changes in the Department's Death and Estate Regulations. This rule details the handling of deaths and estates of American citizens who die abroad. Legislation was passed in the year 2000 amending many of the statutes authorizing the State Department to perform this function. Many of the CFR provisions are unchanged since 1957. Some need revision because of the legislation; others are out of date.

This rule amends the existing regulations in 22 CFR Part 72 and implements sections 234 and 235 of the James W. Nancy and Meg Donovan Foreign Relations Authorization Act, Fiscal Years 2000 and 2001 (Pub. L. 106-113), (hereinafter ``the Act''), as codified in 22 U.S.C. sections 2715(b), 2715b, and 2715c. The current Part 72 will be removed in its entirety, and replaced with the proposed rules.

Section 234 of the Act provides an explicit statutory mandate, codified as 22 U.S.C. 2715b(a), to a consular officer to endeavor to notify, or assist the Secretary of State in notifying, the next of kin or legal guardian as soon as possible when a United States citizen or non-citizen national dies abroad, with certain exceptions. 22 U.S.C. 2715b(a) essentially codifies existing practices concerning consular reporting and notification regarding deaths of United States citizens or non-citizen nationals as reflected in the existing 22 CFR 72.1 through 72.8, with some variations in the exceptions to normal notification procedures. 22 U.S.C. 4196, which provides for the consular officer to notify the legal representative and the Secretary of State of the death of a United States citizen or national abroad, is unaffected by Section 234.

Under the amended regulations, when notifying next of kin of the death of a United States citizen or non-citizen national abroad, such notifications will be made by telephone and confirmed in writing, for example, through an e-mail or fax. The State Department previously used a commercial telegram service to make such notifications.

Section 234 of the Act also explicitly authorizes a consular officer to issue a report of death or of presumptive death in the case of a finding of death by the appropriate local authorities. In addition, it explicitly authorizes a consular officer to issue a report of presumptive death in the absence of a finding of death by the appropriate local authorities. This latter provision is intended to allow the consular officer to issue a report of presumptive death in exceptional circumstances where the evidence that the individual has died ( e.g. , he or she was listed as a passenger on an aircraft that crashed leaving no survivors) is persuasive, but local authorities have not issued and are not likely to issue a finding of death (because e.g. , issuance of a local death certificate requires forensic evidence that is not available or there is no local authority that clearly has jurisdiction.) The Section 234 authorities to issue reports of death are codified at 22 U.S.C. 2715b(b).

Section 234 of the Act further preserves and updates the authority of a consular officer to serve as provisional conservator of the portion of the personal estate of a deceased United States citizen or non-citizen national that is located abroad. It also preserves and updates the authority of a consular officer in “exceptional circumstances” to serve as the administrator of the estate. This authority is now codified at 22 U.S.C. 2715c. (The predecessor statute, 22 U.S.C. 4195, was repealed by Section 234.)

Pursuant to 22 U.S.C. 2715c, a consular officer may serve as provisional conservator or administrator of the personal estate of a United States citizen or non-citizen national only when this is authorized by treaty provisions, permitted by the laws and authorities of the foreign country where the death occurs, or the decedent is domiciled, or permitted by established usage in that foreign country. Serving as a provisional conservator or administrator with respect to the personal estate of a deceased United States citizen or non-citizen national is, however, not authorized if the decedent has left or there is otherwise appointed in the foreign country where the death occurred or where the decedent was domiciled, a legal representative, partner in trade, or trustee appointed to take care of the personal estate. If such a legal representative, partner in trade or trustee appears at any time prior to the transmission of the property to the Secretary of State and demands the proceeds and effects held by the consular officer, the consular officer must deliver them after collecting any fees prescribed for the services performed under 22 U.S.C. 2715c. Consistent with previous statutory authority, 22 U.S.C. 2715c(a)(1) confirms that a consular officer, when serving as provisional conservator of an estate may (A) take possession of the personal effects of the decedent within the consular officer's jurisdiction, (B) inventory and appraise the personal effects, (C) when appropriate in the exercise of prudent administration, collect the debts due to the decedent in the officer's jurisdiction and pay from the estate obligations owed by the decedent, (D) sell or otherwise dispose of, as appropriate, in the exercise of prudent administration, all perishable items of property, (E) sell, after reasonable public notice and notice to such next of kin as can be ascertained with reasonable diligence, additional items of property as necessary to provide funds for the decedent's debts, local property taxes, funeral expenses and other expenses incident to the disposition of the estate; and (F) if no claimant has appeared within the one year period beginning on the date of death (or such reasonable additional period as may be required for final settlement of the estate), sell the residue of the personal estate in the same manner as United States Government-owned foreign excess property, after reasonable public notice and notice to such next of kin as can be ascertained with reasonable diligence.

Prior to enactment of the Legislative Appropriations Act of 1996 (Pub. L. 104-53), the General Accounting Office (GAO) (now the Government Accountability Office) had responsibility for receiving the final statement of account and the personal effects of deceased United States citizens and non-citizen nationals that had been held by consular officers for over one year. Pub. L. 104-53 divested GAO of some of its “operational responsibilities,” including accepting the personal estates of United States citizens and non-citizen nationals who die abroad, and gave such responsibilities to the Executive Branch. Pursuant to Section 234 of the Act, the Department of State now has explicit responsibility for estates formerly transmitted to the GAO. 22 U.S.C. 2715c(a)(1)(G) provides that any proceeds from sale of the residue of the estate shall be transmitted to the Secretary of State, who will have the authority to seek payment of debts to the estate and may take other action that is reasonably necessary for the conservation of the estate. 22 U.S.C. 2715c(b)(1) conveys title of the residue of the estate to the United States if no legal claimant appears within five fiscal years beginning on October 1 after the date on which a consular officer took possession of the personal estate, and gives the Secretary of State the authority to dispose of the estate as surplus United States Government-owned property or such other means as may be appropriate in light of the nature and value of the property involved. The net cash estate after disposition goes to the miscellaneous receipts account of the Treasury.

Another new statutory authority conferred by Section 234 of the Act, and codified in 22 U.S.C. 2715c(a)(1)(H) and 22 U.S.C. 2715c(b)(2), addresses the situation where real property belonging to a deceased United States citizen or non-citizen national lays dormant for lack of a claimant while taxes and other assessments accrue, with the possibility, therefore, that ownership of the property will be transferred to a foreign government authority. In that situation, if local law so provides, the consular officer may provide for title to the property to be conveyed to the United States Government unless the Secretary of State declines to accept the conveyance. Real property conveyed to the Secretary of State may be treated as foreign excess property, or, if the Department of State wants the property for its own use, may be treated as an unconditional gift.

Finally, Section 234 of the Act provides a new authority, codified in 22 U.S.C. 2715c(c), for the Secretary of State to compensate the estate of any United States citizen or non-citizen national who has died overseas for property that was lost, stolen or destroyed while in the custody of officers or employees of the State Department and with respect to which a consular officer was exercising the role of provisional conservator pursuant to 22 U.S.C. 2715 (relating to major disasters and incidents abroad affecting United States citizens) or 22 U.S.C. 2715c(a). Any compensation provided under this provision is in lieu of personal liability of the State Department's officers and employees. State Department officers and employees may be liable to the State Department for any such compensation provided, however, and liability determinations are to be made pursuant to the State Department's procedures for determining accountability for United States Government property. The proposed regulations provide procedures for an estate to claim compensation by reference to Department of State regulations on overseas tort claims under 22 U.S.C. 2669(f).

Existing statutory provisions, 22 U.S.C. 4197 and 22 U.S.C. 4198, prescribe the posting of bond by a consular officer who is appointed by a foreign state as an administrator, guardian or other office of trust for an estate and providing penalties for failure to post bond or for embezzlement, remain in force.

Section 235 of the Act amended 22 U.S.C. 2715 (Procedures regarding major disasters and incidents abroad affecting United States citizens) by, inter alia, defining “consular officer” for the purpose of 22 U.S.C. 2715 and Section 234 of the Act to include any United States citizen employee of the Department of State who is designated by the Secretary of State to perform consular services pursuant to such regulations as the Secretary may prescribe. Accordingly, such designated United States citizen employees now may make notifications of deaths, issue reports of death and presumptive death, and act as provisional conservators of estates.

As stated above, the proposed rule was published on October 24, 2006. The Department received one comment regarding the proposed rule. There were no comments that objected to the proposed changes or the substance of the changes.

The one comment received was intended to improve the language of the proposed rule by making the rule more easily understood. The commenter suggested that Section 72.2 should not begin with an exception and stated that section would read clear if the exception were placed at the end of the rule. The comment is well taken and we have adopted this suggestion, along with additional suggestions by the commenter to make the rule clearer and the language less bureaucratic.

In accordance with provisions of the Administrative Procedure Act governing rules promulgated by Federal agencies that affect the public (5 U.S.C. 533), the State Department is publishing this proposed rule and inviting public comment. All comments received before the close of business on the comment closing date indicated above will be considered.

In accordance with the Regulatory Flexibility Act 5 U.S.C. 605(b), the Department of State has evaluated the effects of this proposed action on small entities, and has determined, and hereby certifies, pursuant to 5 U.S.C. 605(b), that it would not have a significant economic impact on a substantial number of small entities.

This rule is not a major rule as defined by 5 U.S.C. 804 for purposes of congressional review of agency rulemaking under the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121. This rule would not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UFMA), Public Law 104-4; 109 Stat. 48; 2 U.S.C. 1532, generally requires agencies to prepare a statement, including cost-benefit and other analyses, before proposing any rule that may result in an annual expenditure of $100 million or more by State, local, or tribal governments, or by the private sector. This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year. Moreover, because this rule will not significantly or uniquely affect small governments, section 203 of the UFMA, 2 U.S.C. 1533, does not require preparation of a small government agency plan in connection with it.

A rule has federalism implications under Executive Order 13132 if it has substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. This regulation will not have such effects, and therefore does not have sufficient federalism implications to require consultations or to warrant the preparation of a federalism summary impact statement under section 6 of Executive Order 13132.

The Department of State does not consider this rule to be a “significant regulatory action” within the scope of section 3(f)(1) of Executive Order 12866. Nonetheless, the State Department has reviewed the regulation to ensure its consistency with the regulatory philosophy and principles set forth in the Executive Order.

The State Department has reviewed this rule in light of sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden. The State Department has made every reasonable effort to ensure compliance with the requirements in Executive Order 12988.

This rule does not impose any new reporting or recordkeeping requirements subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 35.

Since the enactment of the Jacob Wetterling Crimes Against Children and Sexually Violent Offender Registration Act (42 U.S.C. 14071) in 1994, there have been national standards for sex offender registration and notification in the United States. All states currently have sex offender registration and notification programs and have endeavored to implement the Wetterling Act standards in their existing programs.

Title I of the Adam Walsh Child Protection and Safety Act of 2006 (Pub. L. 109-248), the Sex Offender Registration and Notification Act (SORNA), contains a comprehensive revision of the national standards for sex offender registration and notification. The SORNA reforms are generally designed to strengthen and increase the effectiveness of sex offender registration and notification for the protection of the public, and to eliminate potential gaps and loopholes under the pre-existing standards by means of which sex offenders could attempt to evade registration requirements or the consequences of registration violations. Broadly speaking, the SORNA requirements are of two sorts:

First, SORNA directly imposes registration obligations on sex offenders as a matter of federal law and provides for federal enforcement of these obligations under circumstances supporting federal jurisdiction. These obligations include registration, and keeping the registration current, in each jurisdiction in which a sex offender resides, is an employee, or is a student, with related provisions concerning such matters as the time for registration, the information to be provided by the registrant, and keeping the information up to date. See 42 U.S.C. 16913-16917, enacted by SORNA §§ 113-17.

The enforcement mechanisms for these registration obligations include requirements that the Federal Bureau of Prisons and federal probation offices inform offenders released from federal custody or sentenced to probation who are required to register under SORNA that they must comply with SORNA's requirements, as well as requirements that these federal agencies notify state and local authorities concerning the release of such offenders to their areas. See 18 U.S.C. 4042(c), as amended by SORNA § 141(f)-(h). Federal offenders subject to SORNA are also obligated to comply with its requirements as mandatory conditions of their supervision. See 18 U.S.C. 3563(a)(8), 3583(d), 4209(a), as amended by SORNA § 141(d)-(e), (j). More broadly, 18 U.S.C. 2250, enacted by section 141(a) of SORNA, creates federal criminal liability for any person required to register under SORNA if: (i) the registration requirement is based on a conviction under federal, District of Columbia, Indian tribal, or U.S. territorial law, or the person travels in interstate or foreign commerce or enters or leaves or resides in Indian country, and (ii) the person knowingly fails to register or update a registration as required under SORNA. Because circumstances supporting federal jurisdiction—such as conviction for a federal sex offense as the basis for registration, or interstate travel by a state sex offender who then fails to register in the destination state—are required predicates for federal enforcement of the SORNA registration requirements, creation of these requirements for sex offenders is within the constitutional authority of the Federal Government.

The second broad aspect of SORNA is incorporation by non-federal jurisdictions of the SORNA standards in their own sex offender registration and notification programs. The affected jurisdictions are the states, the District of Columbia, the principal territories, and Indian tribes to the extent provided in SORNA § 127. See 42 U.S.C. 16911(10), enacted by SORNA § 111(10). Section 124 of SORNA generally provides a three-year period for jurisdictions to implement SORNA, subject to possible extension by the Attorney General. See 42 U.S.C. 16924. Jurisdictions that fail to substantially implement SORNA within the applicable period are subject to a 10% reduction of federal justice assistance (Byrne Grant) funding. The SORNA provisions cast as directions to jurisdictions and their officials are, in relation to the states, only conditions required to avoid this funding reduction. See 42 U.S.C. 16925(d), enacted by SORNA § 125(d). Since the SORNA requirements are only partial funding eligibility conditions in relation to the states, and beyond that apply only to jurisdictions that are generally subject to federal legislative authority under the Constitution (D.C., Indian tribal, and U.S. territorial jurisdictions), creation of these requirements is also within the constitutional authority of the Federal Government.

In contrast to SORNA's provision of a three-year grace period for jurisdictions to implement its requirements, SORNA's direct federal law registration requirements for sex offenders are not subject to any deferral of effectiveness. They took effect when SORNA was enacted on July 27, 2006, and currently apply to all offenders in the categories for which SORNA requires registration.

As in the Wetterling Act provisions (42 U.S.C. 14071) that preceded SORNA, Congress recognized in SORNA that supplementation of the statutory text by administrative guidance and rules would be helpful, and in some contexts necessary, to fully realize the legislation's objectives. Section 112(b) of SORNA accordingly directs the Attorney General to issue guidelines and regulations to interpret and implement SORNA. In addition, there are provisions in SORNA that identify specific contexts in which clarification or supplementation of the statutory provisions by the Attorney General is contemplated.

One of these specific contexts appears in section 113(d) of SORNA, which states that “[t]he Attorney General shall have the authority to specify the applicability of the requirements of this title to sex offenders convicted before the enactment of this Act or its implementation in a particular jurisdiction, and to prescribe rules for the registration of any such sex offenders and for other categories of sex offenders who are unable to comply with subsection (b).” 42 U.S.C. 16913(d). (The cross-referenced “subsection (b)” states the normal timing rules for initial registration by sex offenders—before release for imprisoned offenders, and within three business days of sentencing for offenders not sentenced to imprisonment.) Section 113(d) ensures that there will be a means to resolve issues about the scope of SORNA's applicability, including any questions that may arise concerning the retroactive applicability of its requirements to sex offenders convicted prior to its enactment, and a means to fill any gaps there may be concerning registration procedures or requirements for sex offenders to whom the Act's normal procedures cannot be applied.

For example, consider the case of an offender who was convicted of, and sentenced to probation for, a sex offense within the categories for which SORNA requires registration prior to the enactment of SORNA, but who did not register near the time of his sentencing because the offense in question was not subject to a registration requirement under federal law or applicable state law at the time. Following the enactment of SORNA, registration by the sex offender within the normal time period specified in SORNA § 113(b)(2)—not later than three business days after sentencing—is not possible, because that time is past. Under section 113(d), the Attorney General has the authority to specify alternative timing rules for registration of offenders of this type.

The purpose of this interim rule is not to address the full range of matters that are within the Attorney General's authority under section 113(d), much less to carry out the direction to the Attorney General in section 112(b) to issue guidelines and regulations to interpret and implement SORNA as a whole. The Attorney General will hereafter issue general guidelines to provide guidance and assistance to the states and other covered jurisdictions in implementing SORNA, as was done under the Wetterling Act, see 64 FR 572 (Jan. 5, 1999), and may also issue additional regulations as warranted.

The current rulemaking serves the narrower, immediately necessary purpose of foreclosing any dispute as to whether SORNA is applicable where the conviction for the predicate sex offense occurred prior to the enactment of SORNA. This issue is of fundamental importance to the initial operation of SORNA, and to its practical scope for many years, since it determines the applicability of SORNA's requirements to virtually the entire existing sex offender population.

Considered facially, SORNA requires all sex offenders who were convicted of sex offenses in its registration categories to register in relevant jurisdictions, with no exception for sex offenders whose convictions predate the enactment of SORNA. See SORNA §§ 111(1), (5)-(8), 113(a). Nor is there any ex post facto problem in applying the SORNA requirements to such offenders because the SORNA sex offender registration and notification requirements are intended to be non-punitive, regulatory measures adopted for public safety purposes, and hence may validly be applied (and enforced by criminal sanctions) against sex offenders whose predicate convictions occurred prior to the creation of these requirements. See Smith v. Doe, 538 U.S. 84 (2003). Likewise, in terms of underlying policy, the general purpose of SORNA is to “protect the public from sex offenders and offenders against children” by establishing “a comprehensive national system for the registration of those offenders.” 42 U.S.C. 16901, enacted by SORNA § 102. If SORNA were deemed inapplicable to sex offenders convicted prior to its enactment, then the resulting system for registration of sex offenders would be far from “comprehensive,” and would not be effective in protecting the public from sex offenders because most sex offenders who are being released into the community or are now at large would be outside of its scope for years to come. For example, it would not apply to a sex offender convicted of a rape or child molestation offense in 2005, who is sentenced to imprisonment and released in 2020.

Nevertheless, sex offenders with predicate convictions predating SORNA who do not wish to be subject to the SORNA registration requirements, or who wish to avoid being held to account for having violated those requirements, have not been barred from attempting to devise arguments that SORNA is inapplicable to them, e.g., because a rule confirming SORNA's applicability has not been issued. This rule forecloses such claims by making it indisputably clear that SORNA applies to all sex offenders (as the Act defines that term) regardless of when they were convicted. The Attorney General exercises his authority under section 113(d) of SORNA to specify this scope of application for SORNA, regardless of whether SORNA would apply with such scope absent this rule, in order to ensure the effective protection of the public from sex offenders through a comprehensive national system for the registration of such offenders.

The rule adds a new Part 72 to 28 CFR with three sections. Section 72.1 explains that the purpose of this rule is to specify the applicability of the SORNA requirements to sex offenders convicted prior to the Act's enactment. Section 72.2 states that terms used in the regulations have the same meaning as in SORNA § 111. Thus, the statutory definitions may be consulted as to the meaning of such terms as “sex offender,” “convicted,” and “jurisdiction.” Section 72.3 states that the SORNA requirements apply to all sex offenders, including sex offenders convicted of their registration offenses before the enactment of SORNA, and provides illustrations.

The implementation of this rule as an interim rule, with provisions for post-promulgation public comments, is based on the “good cause” exceptions found at 5 U.S.C. 553(b)(3)(B) and (d)(3), for circumstances in which “notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. 553(b)(3)(B).

The rule specifies that the requirements of the Sex Offender Registration and Notification Act apply to all sex offenders (as defined in that Act), including those convicted of the offense for which registration is required prior to the enactment of the Act. The applicability of the Act's requirements promotes the effective tracking of sex offenders following their release, by means described in sections 112-17 and 119 of the Act, and the availability of information concerning their identities and locations to law enforcement and members of the public, by means described in sections 118 and 121 of the Act.

The immediate effectiveness of this rule is necessary to eliminate any possible uncertainty about the applicability of the Act's requirements—and related means of enforcement, including criminal liability under 18 U.S.C. 2250 for sex offenders who knowingly fail to register as required—to sex offenders whose predicate convictions predate the enactment of SORNA. Delay in the implementation of this rule would impede the effective registration of such sex offenders and would impair immediate efforts to protect the public from sex offenders who fail to register through prosecution and the imposition of criminal sanctions. The resulting practical dangers include the commission of additional sexual assaults and child sexual abuse or exploitation offenses by sex offenders that could have been prevented had local authorities and the community been aware of their presence, in addition to greater difficulty in apprehending perpetrators who have not been registered and tracked as provided by SORNA. This would thwart the legislative objective of “protect[ing] the public from sex offenders and offenders against children” by establishing “a comprehensive national system for the registration of those offenders,” SORNA § 102, because a substantial class of sex offenders could evade the Act's registration requirements and enforcement mechanisms during the pendency of a proposed rule and delay in the effectiveness of a final rule.

It would accordingly be contrary to the public interest to adopt this rule with the prior notice and comment period normally required under 5 U.S.C. 553(b) or with the delayed effective date normally required under 5 U.S.C. 553(d).

The Attorney General, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and by approving it certifies that this regulation will not have a significant economic impact on a substantial number of small entities for the purposes of that Act because the regulation concerns the application of the requirements of the Sex Offender Registration and Notification Act to certain offenders.

This regulation has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review,” section 1(b), Principles of Regulation. The Department of Justice has determined that this rule is a “significant regulatory action” under Executive Order 12866, section 3(f), and accordingly this rule has been reviewed by the Office of Management and Budget.

This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. There has been substantial consultation with state officials regarding the interpretation and implementation of the Sex Offender Registration and Notification Act. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism assessment.

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996. 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, or innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

Background: The Oil Pollution Act of 1990 (OPA 90) (Pub. L. 101-380) expanded and strengthened MMS's authority to impose penalties for violating regulations promulgated under the Outer Continental Shelf (OCS) Lands Act. Section 8201 of OPA 90 (43 U.S.C. 1350) authorizes the Secretary of the Interior (Secretary) to assess a civil penalty without providing notice and time for corrective action where a failure to comply with applicable regulations results in a threat of serious, irreparable, or immediate harm or damage to human life or the environment. The goal of the MMS OCS Civil Penalty Program is to ensure safe and clean operations on the OCS. By pursuing, assessing, and collecting civil penalties, the program is designed to encourage compliance with OCS statutes and regulations.

Not all regulatory violations warrant a review to initiate civil penalty proceedings; however, violations that cause injury, death, or environmental damage, or pose a threat to human life or the environment, will trigger such review.

Every 3 years, in accordance with OPA 90 (43 U.S.C. 1350(b)(1)), MMS analyzes the civil penalty maximum amount in conjunction with the CPI prepared by the U.S. Department of Labor. If an adjustment is necessary, MMS informs the public through the Federal Register of the new maximum amount. MMS uses Office of Management and Budget (OMB) guidelines for determining how penalty amounts should be rounded. In computing this new civil penalty maximum amount, MMS divided the August 2006 CPI of 203.9 by the previously used August 2002 CPI of 180.7. This resulted in a multiplying factor of 1.13. The previous maximum amount of $30,000 per violation per day was multiplied by the 1.13 factor and resulted in a new maximum penalty amount of $33,900. This amount was rounded to $35,000 as per OMB guidelines. The new civil penalty maximum amount is now $35,000 per violation per day. It must be remembered that this is a maximum amount and is only used when a non-compliance issue warrants it.

OPA 90 also established civil penalties for failure to comply with financial responsibility regulations. Section 4303 of OPA 90 (33 U.S.C. 2716a) authorized the President (and, by delegation, the Secretary) to assess a civil penalty of up to $25,000 per day for each violation. The Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410) established a 4-year cycle for review and adjustment of all federally imposed civil monetary penalties in order to maintain the deterrent effect of such penalties, and promote compliance with the law. The cost-of-living adjustment process (set out in a note to 28 U.S.C. 2461) is the same as that described above. Applying the multiplying factor of 1.13 to the previous maximum amount of $25,000, results in a new maximum civil penalty of $28,250 per violation per day. However, Section 3720E of the Omnibus Appropriations Act of 1996 (Pub. L. 104-134) included a provision limiting the first adjustment of any civil penalty pursuant to the 1990 Act to 10 percent. This is the first adjustment of 33 U.S.C. 2716a. The new civil penalty maximum amount under 33 U.S.C. 2716a is therefore $27,500 per violation per day.

This final rule is not a significant rule as determined by the OMB and is not subject to review under E.O. 12866.

(1) This final rule will not have an annual effect of $100 million or more on the economy. It will not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. This final rule simply adjusts the maximum civil penalty amount using the CPI.

(2) This final rule will not create a serious inconsistency or otherwise interfere with action taken or planned by another agency because the rule only adjusts the civil penalty maximum.

(3) This final rule will not alter the budgetary effects of entitlements, grants, user fees or loan programs, or the rights or obligations of their recipients. The changes in this final rule simply adjust the civil penalty maximum.

(4) This final rule will not raise novel legal or policy issues.

The Department of the Interior (DOI) certifies that this final rule will not have a significant economic effect on a substantial number of small entities under the RFA (5 U.S.C. 601 et seq. ). This final rule applies to all lessees that operate on the OCS. Generally, lessees that operate under this rule would fall under the Small Business Administration's (SBA) North American Industry Classification System Codes 211111, Crude Petroleum and Natural Gas Extraction and 213111, Drilling Oil and Gas Wells. Under these codes, the SBA considers all companies with fewer than 500 employees to be a small business. We estimate that of the 130 lessees that explore for and produce oil and gas on the OCS, approximately 90 are small businesses (70 percent). The primary effect of the final rule is the increase in civil penalties assessed only for those operators that do not comply with Federal OCS regulations.

This rule will have no impact on the oil and gas industry operators that comply with Federal OCS regulations. For those operators whose non-compliance results in a civil penalty, the increase resulting from the inflation factor of 1.13 amounts to an increase of less than $170,000 spread over an average of 39 cases per year or slightly under $4,400 additional per case. This is using data over the past 10 years and averaging civil penalties paid and number of cases paid per year. This dollar amount is minor considering the substantial costs of operations on the OCS. This is true for even the smallest of OCS operators.

Your comments are important. The Small Business and Agriculture Regulatory Enforcement Ombudsman and 10 Regional Fairness Boards were established to receive comments from small business about Federal agency enforcement actions. The Ombudsman will annually evaluate the enforcement activities and rate each agency's responsiveness to small business. If you wish to comment on the actions of MMS, call 1-888-734-3247. You may comment to the SBA without fear of retaliation. Disciplinary action for retaliation by an MMS employee may include suspension or termination from employment with the DOI.

This final rule is not a major rule under the SBREFA (5 U.S.C. 804(2)). This final rule:

a. Will not have an annual effect on the economy of $100 million or more. As described above, we estimate an annual increase of $4,400 per civil penalty case.

b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. The minor increase in cost will not change the way the oil and gas industry conducts business, nor will it affect regional oil and gas prices. Therefore, it will not cause major cost increases for consumers, the oil and gas industry, or any Government agencies.

c. Will not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. Leasing on the U.S. OCS is limited to residents of the U.S. or companies incorporated in the U.S. This final rule will not change that requirement.

This final rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The final rule will not have a significant or unique effect on State, local, or tribal governments or the private sector. A statement containing the information required by UMRA (2 U.S.C. 1531 et seq. ) is not required. This is because the final rule will not affect State, local, or tribal governments, and the effect on the private sector is small.

The final rule is not a governmental action capable of interference with constitutionally protected property rights. Thus, MMS did not need to prepare a Takings Implication Assessment according to E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

With respect to E.O. 13132, this final rule will not have federalism implications. This final rule will not substantially and directly affect the relationship between the Federal and State governments. To the extent that State and local governments have a role in OCS activities, this final rule will not affect that role.

With respect to E.O. 12988, The Office of the Solicitor has determined that the final rule does not unduly burden the judicial system and does meet the requirements of sections 3(a) and 3(b)(2) of the Order.

This final rule does not contain any information collection subject to the PRA, and does not require a submittal to OMB for review and approval under section 3507(d) of the PRA.

The final rulemaking does not introduce requirements that would cause lessees or operators to perform or change any activities on the OCS which would result in environmental impacts beyond those addressed in the NEPA documents associated with the OCS plans.

MMS has analyzed this final rule according to the criteria of the NEPA and 516 Department Manual 6, Appendix 10.4C(1), “Issuance and/or modification of regulations.” This final rule does not constitute a major Federal action significantly affecting the quality of the human environment and falls within the categorical exclusion of Appendix 10.4C(1) because the impact of the final rule will be limited to administrative and economic effects. A detailed statement under the NEPA is not required.

Executive Order 13211 requires the agency to prepare a Statement of Energy Effects when it takes a regulatory action that is identified as a significant energy action. This final rule is not a significant energy action, and therefore would not require a Statement of Energy Effects because it:

a. Is not a significant regulatory action under E.O. 12866,

b. Is not likely to have a significant adverse effect on the supply, distribution, or use of energy, and

c. Has not been designated by the Administrator of the Office of Information and Regulatory Affairs, OMB, as a significant energy action.

Under the criteria in E.O. 13175, we have evaluated this final rule and determined that it has no potential effects on federally recognized Indian tribes. There are no Indian or tribal lands on the OCS.

Background: Since 1987, OCS operators have reported encountering SWF problems while drilling in specific areas of the Gulf of Mexico (GOM). Between 1987 and 2004, MMS is aware of at least 113 wells, drilled by approximately 25 different operators, that encountered problems with SWF. General information on SWFs, and maps showing the location of areas in the GOM that have had documented cases of SWF, can be viewed at our Web site: http://www.gomr.mms.gov/homepg/offshore/safety/wtrflow.html.

This final rule updates the requirements for cementing operations in 30 CFR Part 250 Subpart A—General, and Subpart D—Oil and Gas Drilling Operations. Subpart A is amended to incorporate by reference “API RP 65, Recommended Practice for Cementing SWF Zones in Deep Water Wells,” First Edition, September 2002. Subpart D is amended by adding new subparagraph (e) to § 250.415, detailing when API RP 65 is to be evaluated by an operator in designing a cementing program. Some of the key points of this final rulemaking include the following:

• Use of this standard is not warranted for every OCS well, or for all casing strings in a particular well. Its use is limited to situations where there is a risk of encountering a SWF based upon past drilling activity, seismic data or interpretation, or correlation of data from offset wells in water depths greater than 500 feet (SWF has not been encountered in wells in water depths less than 500 feet).

• The risk associated with encountering a SWF is characterized in one of two ways: (1) An area with an unknown SWF potential, or (2) an area known to contain a SWF hazard.

• For purposes of this final rule, these terms are defined as follows:

• Use of this standard is limited to water depths greater than 500 feet for areas with an unknown SWF potential or areas known to contain a SWF hazard. Data available to the MMS on the 113 wells that have encountered SWF show that the water depths for these wells ranged from approximately 500 feet to 9,675 feet, with an average water depth of 3,560 feet.

• As part of an operator's Application for Permit to Drill (Form MMS-123), a statement needs to be included concerning how API RP 65 was evaluated by the operator. The operator must also detail which of the cementing techniques from this standard were used as part of the cementing program for a well drilled in either “areas with an unknown SWF potential” or “areas known to contain a SWF hazard.” This information will be evaluated by MMS during the review of the application for permit to drill, and discussed with the operator as appropriate.

• Particular attention should be placed on evaluating, designing, and implementing the cementing programs of both the surface and conductor casing strings in wells requiring review under API RP 65. Data available to the MMS on the 113 wells that have encountered SWF show that the tops of the SWF zones ranged from approximately 450 feet below mud line to 3,005 feet below mud line, with an average depth of encounter of 1,305 feet below mud line. These depths are typical of the setting depths of either conductor or surface casings.

Comments on the Rule: On May 22, 2006, MMS published a proposed rule (71 FR 29280) to incorporate API RP 65. The public comment period ended on July 21, 2006. MMS received six comments on the proposed rule. All the comments came from companies or organizations working in the oil and gas industry, including ExxonMobil, BP, Devon, BJ Services Company, Schlumberger, and the Offshore Operators Committee (OOC). A majority of the comments addressed similar issues mostly on the bias toward using foam cement to address the SWF issue in sections of the RP. Other comments expressed concern that singling out a specific cementing technique hinders new methods and technology development, and that this RP is not appropriate for other cementing applications. You may view these comments on MMS' Public Connect on-line commenting system at: http://www.mms.gov/federalregister/PublicComments/APIRP65.htm.

Discussion of Comments:

Comment: Five out of the six comments wanted MMS to omit appendix F of API RP 65. The comments suggest omitting this appendix due to a perceived bias toward use of foam cementing. At the time the RP was developed, foam was the best available cement system for use in combating SWFs. Since development of this standard, new options have been developed that are similarly efficient, i.e., non-compressible systems. A few comments also recommend omitting appendices D and E due to bias toward foam cement.

Response: MMS agrees that there appears to be a bias toward the use of foam cement in appendices D, E, and F. However, under this final rulemaking, MMS does not require a company to comply with the provisions contained in these appendices or submit any information related to these appendices. MMS views the appendices in this RP as examples and background information. With specific reference to appendix F, even with the apparent bias towards use of foam cement, MMS still views the cementing matrix as a useful tool that can help a company evaluate the performance of their cement jobs and improve upon subsequent cement operations.

Comment: One comment provided further recommendations and alternate language to change sections 11.1, 11.2, and 11.3 of the RP to eliminate bias towards foam cement.

Response: MMS does not have the authority to change an API document. While MMS could elect not to incorporate by reference specified provisions of the document, it has instead opted to incorporate API RP 65, First Edition (September 2002) in its entirety. API updates these recommended practices periodically through a consensus-based process. MMS believes it best that the changes suggested by this commenter be proposed to the API review committee so that they can be considered by a cross-section of industry. If the proposals are adopted by API, and incorporated into a revised edition of this RP, MMS would then have the option to consider incorporating the revised edition into the regulations.

This final rule is not a significant rule as determined by the Office of Management and Budget (OMB), and is not subject to review under E.O. 12866.

(1) The final rule will not have an annual effect of $100 million or more on the economy. It will not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities.

The economic analysis prepared by the MMS indicates that, if the techniques included in API RP 65 are evaluated by operating companies in the planning phases of wells drilled in Areas with an Unknown SWF Potential or Areas Known to Contain a SWF Hazard, this process will increase the planning costs associated with these wells by no more than $20,000 per well (industry estimate). This cost includes planning associated with a full range of SWF mitigation measures. The measures include casing centralization; pipe movement; use of light weight cements such as a foam system; use of non-compressible systems; proper mud circulation prior to cementing; site selection; the drilling of pilot holes; setting extra strings of casing; use of measurement while drilling technology; pressure while drilling technology; and use of a drilling riser for shallow sections of a deep water well. Today, most lessees conducting operations in SWF-prone areas already use most of these techniques. As a result, additional costs associated with implementing these techniques under this final rule will be negligible.

Based on information available to MMS, there have been a total of 1,275 wells drilled on the OCS in water depths of 500 feet or greater during the period 2000-2004. The cost to industry over the past 5 years for SWF mitigation would have been approximately $25.5 million ($20,000 per well × 1,275 wells = $25.5 million) if the evaluations required for this final rule were conducted prior to drilling all of these wells. In reality, a significant number of the 1,275 wells would have been located in areas known to be free of SWF, and would not have required an operating company to implement the techniques included in API RP 65 as part of their well planning efforts, resulting in a significantly lower cost to the offshore industry.

Using the well data trends from 2000-2004, in water depths greater than 500 feet, MMS estimates an average of 200 wells will be drilled per year. Using the average of 200 wells, the estimated annual cost to industry will be approximately $4 million ($20,000 per well × 200 wells = $4 million). Based on actual drilling figures, estimated total well costs are in excess of $40 million per well. Industry estimates of $20,000 per well for SWF mitigation represents only 0.05 percent of total well costs. The possible consequences of SWF, well abandonment, or well loss are far more severe than the 0.05 percent of well costs for SWF mitigation.

For the above reasons, the final rule will have a minor economic effect on the offshore oil and gas industry.

(2) The final rule will not create a serious inconsistency or otherwise interfere with action taken or planned by another agency. It will not change the relationships of the OCS oil and gas leasing program with other agencies' actions.

(3) This final rule will not alter the budgetary effects of entitlements, grants, user fees or loan programs, or the rights or obligations of their recipients. The changes proposed in this rule are strictly planning requirements for specific well cementing processes to prevent accidents and environmental pollution on the OCS.

(4) This final rule will not raise novel legal or policy issues.

The Department certifies that this final rule will not have a significant economic effect on a substantial number of small entities under the RFA (5 U.S.C. 601 et seq. ).

The changes in the final rule will affect lessees and operators of leases on the OCS. This could include about 130 active Federal oil and gas lessees. Small lessees that operate under this rule fall under the Small Business Administration's (SBA) North American Industry Classification System (NAICS) codes 211111, Crude Petroleum and Natural Gas Extraction, and 213111, Drilling Oil and Gas Wells. For these NAICS code classifications, a small company is one with fewer than 500 employees. Based on these criteria, an estimated 70 percent of these companies are considered small. This final rule will therefore affect a substantial number of small entities.

As previously stated, there have been a total of 1,275 wells drilled on the OCS in water depths of 500 feet or greater during the period 2000-2004. Of the total 1,275 wells drilled, 1,107 were drilled by large businesses and 168 by small businesses. The 168 wells were drilled by a total of 15 small businesses. The 1,107 large business wells correspond to 87 percent of all wells drilled, leaving 13 percent as small business wells.

The final rule will have a minor economic effect on the oil and gas offshore lessees and operators on the OCS, regardless of company size. This is due to the relatively small SWF mitigation costs in relation to the high drilling costs. Because of the high potential costs of SWF, well abandonment, or well loss, in the overwhelming majority of cases operators choose to perform improved and safer well cementing procedures on their own initiative, not because of MMS safety requirements. The final rule will add relatively little to the cost of a well cementing procedure. Thus, there will not be a significant impact on a substantial number of small entities under the RFA (5 U.S.C. 601 et seq. ). The final rule will not cause the business practices of any of these companies to change.

Your comments are important. The Small Business and Agriculture Regulatory Enforcement Ombudsman and 10 Regional Fairness Boards were established to receive comments from small businesses about Federal agency enforcement actions. The Ombudsman will annually evaluate the enforcement activities and rate each agency's responsiveness to small business. If you wish to comment on the actions of MMS, call 1-888-734-3247. You may comment to the Small Business Administration without fear of retaliation. Disciplinary action for retaliation by an MMS employee may include suspension or termination from employment with the DOI.

The final rule is not a major rule under the SBREFA (5 U.S.C. 804(2)). This final rule:

a. Will not have an annual effect on the economy of $100 million or more.

b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

c. Will not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. Leasing on the OCS is limited to residents of the U.S. or companies incorporated in the U.S. This final rule will not change that requirement.

This final rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The final rule will not have a significant or unique effect on State, local, or tribal governments or the private sector. A statement containing the information required by UMRA (2 U.S.C. 1531 et seq. ) is not required.

This final rule is not a governmental action capable of interference with constitutionally protected property rights. Thus, MMS did not need to prepare a Takings Implication Assessment according to E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

With respect to E.O. 13132, this final rule will not have federalism implications. This final rule will not substantially and directly affect the relationship between the Federal and State governments. To the extent that State and local governments have a role in OCS activities, this final rule will not affect that role.

With respect to E.O. 12988, the Office of the Solicitor has determined that the final rule does not unduly burden the judicial system and does meet the requirements of sections 3(a) and 3(b)(2) of the Order.

The revisions to 30 CFR 250 refer to, but do not change, information collection requirements in current regulations. They impose no new reporting or recordkeeping requirements and a submission to OMB under § 3507(d) of the PRA is not required. The PRA provides that an agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. Until OMB approves a collection of information and assigns a number, you are not required to respond. OMB approved the referenced information collection requirements for 30 CFR part 250 under OMB Control Numbers 1010-0114 (22,538 burden hours), expiration October 31, 2007, and 1010-0141 (163,714 burden hours), expiration August 31, 2008.

This rule does not constitute a major Federal action significantly affecting the quality of the human environment. MMS has analyzed this rule under the criteria of the NEPA and 516 Departmental Manual 6, Appendix 10.4C(1). MMS completed a Categorical Exclusion Review for this action and concluded that “the rulemaking does not represent an exception to the established criteria for categorical exclusion; therefore, preparation of an environmental analysis or environmental impact statement will not be required.”

Executive Order 13211 requires the agency to prepare a Statement of Energy Effects when it takes a regulatory action that is identified as a significant energy action. This final rule is not a significant energy action; and therefore, will not require a Statement of Energy Effects because it:

a. Is not a significant regulatory action under E.O. 12866,

b. Is not likely to have a significant adverse effect on the supply, distribution, or use of energy, and

c. Has not been designated by the Administrator of the Office of Information and Regulatory Affairs, OMB, as a significant energy action.

Under the criteria in E.O. 13175, we have evaluated this final rule and determined that it has no potential effects on federally recognized Indian tribes. There are no Indian or tribal lands on the OCS.

The SIP is a living document which the State revises as necessary to address the unique air pollution problems. Therefore, EPA from time to time must take action on SIP revisions containing new and/or revised regulations to make them part of the SIP. On May 22, 1997 (62 FR 27968), EPA revised the procedures for incorporating by reference Federally-approved SIPs, as a result of consultations between EPA and the Office of the Federal Register (OFR). The description of the revised SIP document, IBR procedures and “Identification of plan” format are discussed in further detail in the May 22, 1997 Federal Register document. On February 10, 2005 (70 FR 7024), EPA published a Federal Register beginning the new IBR procedure for West Virginia. In this document, EPA is doing the following:

1. Announcing the update to the IBR material as of December 15, 2006.

2. Making corrections to the following entries listed in the paragraph 52.2520(c) chart, as described below:

a. 45 CSR 14, “State citation [Chapter 16-20 or 45 CSR]” column—revising the entries for the regulation citation and Sections 45-14-2, 45-14-3, and 45-14-19.

b. 45 CSR 14, “Title/subject” column—revising the entry for Section 45-14-25.

c. 45 CSR 14, “State effective date” column, all entries—revising the effective date from “6/2/05” to “6/1/05.”

d. 45 CSR 19—Adding entries for Tables 45-19A and 45-19B. These tables were part of the regulatory text of 45 CSR 19 which EPA approved as a revision of the West Virginia SIP on November 2, 2006 (71 FR 64668), but were inadvertently omitted from the amended rule for 40 CFR 52.2520(c) published at 71 FR 64670.

e. 45 CSR 19, “State citation [Chapter 16-20 or 45 CSR]” column—revising the entries for the regulation citation and Sections 45-14-2, 45-14-3, and 45-14-17.

f. 45 CSR 19, “Title/subject” column—revising the entry for Section 45-19-23.

g. 45 CSR 19, “State effective date” column, all entries—revising the effective date from “6/2/05” to “6/1/05.”

h. 45 CSR 14 and 45 CSR 19, “Additional explanation at 40 CFR 52.2565” column, all entries—adding the SIP effective date for each entry.

3. Making corrections to the title of the “Additional information” column in the paragraph 52.2520(d) chart.

EPA has determined that today's rule falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedures Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation, and section 553(d)(3) which allows an agency to make a rule effective immediately (thereby avoiding the 30-day delayed effective date otherwise provided for in the APA). Today's rule simply codifies provisions which are already in effect as a matter of law in Federal and approved State programs. Under section 553 of the APA, an agency may find good cause where procedures are “impractical, unnecessary, or contrary to the public interest.” Public comment is “unnecessary” and “contrary to the public interest” since the codification only reflects existing law. Immediate notice in the CFR benefits the public by removing outdated citations and incorrect chart entries.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this 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 rule is not a “major rule” as defined by 5 U.S.C. 804(2).

EPA has also determined that the provisions of section 307(b)(1) of the Clean Air Act pertaining to petitions for judicial review are not applicable to this action. Prior EPA rulemaking actions for each individual component of the West Virginia SIP compilations had previously afforded interested parties the opportunity to file a petition for judicial review in the United States Court of Appeals for the appropriate circuit within 60 days of such rulemaking action. Thus, EPA sees no need in this action to reopen the 60-day period for filing such petitions for judicial review for this “Identification of plan” reorganization update action for West Virginia.

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you may access this “ Federal Register ” document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr .

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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-2006-0603 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before April 30, 2007.

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 that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0603, by one of the following methods.

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line instructions for submitting comments.

• Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

• Delivery : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is (703) 305-5805.

In the Federal Register of July 26, 2006 (71 FR 42393) (FRL-8079-5), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 6E7085) by MonoSol, LLC, 1701 County Line Road, Portage, IN 46368. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts; CAS Reg. No. 886993-11-9. That notice included a summary of the petition prepared by the petitioner. There were no comments in response to the notice of filing.

Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) of the 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 the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . .” and specifies factors EPA is to consider in establishing an exemption.

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

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

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

1. The polymer, 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts, is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

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

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

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

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

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

Additionally, the polymer, 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts, also meets as required the following exemption criteria specified in 40 CFR 723.250(e).

7. The polymer's number average MW is greater than or equal to 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000.

Thus, 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts meet all the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the above criteria, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts.

For the purposes of assessing potential exposure under this exemption, EPA considered that 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts is 36,200 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts conform to the criteria that identify a low risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, the Agency consider “available information” concerning the cumulative effects of a particular chemical's residues and “other substances that have a common mechanism of toxicity.” EPA does not have, at this time, available data to determine whether 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts has a common mechanism of toxicity with other substances. 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 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts and any other substances and 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts 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 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts 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 website at http://www.epa.gov/pesticides/cumulative .

Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

Based on the conformance to the criteria used to identify a low risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts.

There is no available evidence that 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts is an endocrine disruptor.

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

The Agency is not aware of any country requiring a tolerance for 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.

Accordingly, EPA finds that exempting residues of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts from the requirement of a tolerance will be safe.

This final rule establishes an exemption from the tolerance requirement under section 408(d) of the FFDCA 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 rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). 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); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

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

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

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

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm .

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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-2006-0321 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before April 30, 2007.

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 that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0321, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov . Follow the on-line instructions for submitting comments.

•  Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

•  Delivery : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is (703) 305-5805.

In the Federal Register of July 5, 2006 (71 FR 38154) (FRL-8074-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 0E6204 and 4E6885) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petitions requested that 40 CFR 180.412 be amended by establishing tolerances for combined residues of the herbicide sethoxydim {2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one} and its metabolites containing the 2-cyclohexen-1-one moiety in or on turnip tops at 5.0 parts per million (ppm) (PP 0E6204) and buckwheat, grain at 20 ppm; buckwheat, flour at 20 ppm; borage; seed at 5.0 ppm; borage, meal at 40 ppm; borage, oil at 40 ppm; dill, fresh leaves at 10 ppm; dill, dried leaves at 10 ppm; okra at 4.0 ppm; vegetable root, except sugar beet, group 1B at 4.0 ppm; and radish tops at 5.0 ppm (4E6885). That notice referenced a summary of the petition prepared by BASF Corporation, the registrant, that is available in EPA's electronic docket. There were no comments received in response to the notice of filing.

Upon completing review of the current sethoxydim database, the Agency concluded that the appropriate tolerance levels and preferred commodity terms for sethoxydim residues in or on pending crops should be established as follows: Buckwheat, grain at 19 ppm; buckwheat, flour at 25 ppm; okra at 2.5 ppm; borage, seed at 6.0 ppm; borage, meal at 10 ppm; dillweed, fresh leaves at 10 ppm; radish, tops at 4.5 ppm; turnip, greens at 5.0 ppm and Vegetable, root and tuber, group 1 at 4.0 ppm. Vegetable, root and tuber, group 1 incorporates both the request for vegetable root, except sugar beet, group 1B at 4.0 ppm and existing tolerances for carrot, roots at 1.0 ppm; horseradish at 4.0 ppm; beet, garden at 1.0 ppm; beet, sugar, root at 1.0 ppm; and tuberous and corm vegetable subgroup 1D at 4.0 ppm. Turnip, greens replaces the term turnip tops. In addition, the proposed tolerance for borage oil was withdrawn because no separate tolerance is required since oil is covered by the borage seed tolerance and the proposed tolerance for dill, dried leaves was withdrawn because no separate tolerance is required since dried dillweed is covered by the fresh dillweed tolerance.

EPA is also deleting several established tolerances in section 180.412(a) that are no longer needed as a result of this action. The revisions to section 180.412(a) are as follows: Delete beet, garden at 1.0 ppm; beet, sugar, roots at 1.0 ppm; carrot, roots at 1.0 ppm; horseradish at 4.0 ppm; and tuberous and corm vegetable crop subgroup at 4.0 ppm. All of these tolerances are replaced with vegetable, root and tuber, group 1 at 4.0 ppm.

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. . . .”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm and http://www.epa.gov/fedrgstr/EPA-PEST/2003/July/Day-30/p19357.htm.

Consistent with section 408(b)(2)(D) of FFDCA, 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 section 408(b)(2) of FFDCA, for tolerances for combined residues of sethoxydim and its metabolites containing the 2-cyclohexen-1-one moiety on buckwheat, grain at 19 ppm; buckwheat, flour at 25 ppm; okra at 2.5 ppm; borage, seed at 6.0 ppm; borage, meal at 10 ppm; dillweed, fresh leaves at 10 ppm; radish, tops at 4.5 ppm; turnip, greens at 5.0 ppm and vegetable, root and tuber, group 1 at 4.0 ppm. 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. Specific information on the studies received and the nature of the toxic effects caused by sethoxydim as well as the no-observed-adverse-effect-level (the NOAEL) and the lowest-observed-adverse-effect-level (the LOAEL) from the toxicity studies can be found in the final rule published in the Federal Register of September 29, 2003 (68 FR 55858) (http://www.epa.gov/EPA-PEST/2003/September/Day-29/p24562.htm).

For hazards that have a threshold below which there is no appreciable risk, the dose at which the (NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the (LOAEL) of concern are identified is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at be found on the general principles EPA uses in risk characterization at http://www.epa.gov/pesticides/health/human.htm.

A summary of the toxicological endpoints for sethoxydim used for human risk assessment can be found at www.regulations.gov in document 0003 (page 9) in Docket ID EPA-HQ-OPP-2006-0321. To locate this information on the Regulations.gov website follow these steps:

Select “Advanced Search”, then “Docket Search.”

In the “Keyword” field type the chemical name or insert the applicable “Docket ID number.” (example: EPA-HQ-OPP-2005-9999).

Click the “Submit”button.

Follow the instructions on the regulations.gov web site to view the index for the docket and access available documents.

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.412) for the combined residues of sethoxydim and its 2-cyclohexen-1-one moiety containing metabolites, in or on a variety of raw agricultural commodities. Tolerances have also been established for combined residues of sethoxydim in or on milk, egg, and fat, meat, and meat byproducts of cattle, goat, hog, horse, poultry and sheep. Risk assessments were conducted by EPA to assess dietary exposures from sethoxydim 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 one-day or single exposure.

In conducting the acute dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: For all proposed new uses and for all commodities in Vegetable, root and tuber, group 1, tolerance level residues and 100 percent crop treated (PCT) were assumed. For the remaining crops with existing tolerances available maximum PCT values were used. Tolerance level residues were assumed for most crops except for grapes, oranges, potatoes, tomatoes, strawberries, apples, pears and other pome fruits where anticipated residues were calculated through the incorporation of field trial data. Empirical processing data for apples, grapes, tomatoes, potatoes and oranges were used, and were sometimes translated to other members of the crop group. For livestock commodities, the available PCT information was incorporated into the dietary burden calculation and the feeding studies were used to determine the appropriate residue level, however at least one food item in each diet was assumed to be 100 PCT. PCT information was incorporated into the acute exposure and risk assessments through use of probabilistic risk assessment model.

ii. Chronic exposure . In conducting the chronic dietary exposure assessment EPA used the DEEM TM software with the Food Commodity Intake Database, which incorporates food consumption data as reported by respondents in the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: For the proposed new uses and all commodities in Vegetable, root and tuber, group 1 tolerance level residues and 100% CT were assumed. For most of the crops with existing tolerances, tolerance level residues and average PCT values were assumed. PCT data for some livestock feeds were incorporated into the calculations of the theoretical dietary burdens for livestock, which were then used in conjunction with the available feeding studies to determine the anticipated residues in livestock commodities.

iii. Cancer . The Agency has classified sethoxydim as not likely to be a human carcinogen based on lack of evidence of carcinogenicity in rats and mice. Therefore, a cancer dietary exposure assessment was not performed

iv. Anticipated residue and PCT information . Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must pursuant to section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. For the present action, EPA will issue such Data Call-Ins for information relating to anticipated residues as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such Data Call-Ins will be required to be submitted no later than 5 years from the date of issuance of this tolerance.

Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT.

The Agency used PCT information for the chronic dietary risk assessment as follows: 1% apples, 1% apricots, 6% globe artichokes, 5% asparagus, 14% dry beans, 9% lima beans, 8% snap beans, 5% garden beet tops, 1% broccoli, 5% cabbage, 8% cantaloupes, 2% cauliflower, 1% cherries, 2% collards, 1% corn, 1% cotton, 8% cranberries, 6% cucumbers, 5% eggplants, 38% flax, 1% grapes, 1% grapefruits, 5% lemons, 1% lettuce, 1% nectarines, 3% oranges, 2% succulent peas, 14% dry peas, 1% peaches, 5% peanuts, 1% pears, 3% bell peppers, 6% nonbell peppers, 4% potatoes, 8% pumpkins, 4% rapeseed, 6% rhubarb, 2% soybeans, 1% spinach, 8% summer squash, 5% strawberry, 14% sunflower, 4% tomatoes, 5% turnip greens, and 12% watermelons.

EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available Federal, State, and private market survey data for that use, averaging by year, averaging across all years, and rounding up to the nearest multiple of five percent except for those situations in which the average PCT is less than one. In those cases < 1% is used as the average and < 2.5% is used as the maximum. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the single maximum value reported overall from available federal, state, and private market survey data on the existing use, across all years, and rounded up to the nearest multiple of five percent. In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), Proprietary Market Surveys, and the National Center for Food and Agriculture Policy (NCFAP) for the most recent six years.

The Agency believes that the three conditions listed III.C.1.iv. have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which sethoxydim may be applied in a particular area.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for sethoxydim in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of sethoxydim. 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 First Index Screening Tool Reservoir (FIRST) and Screening Concentration in Groundwater (SCI-GROW) models, the estimated environmental concentrations (EECs) of sethoxydim for acute exposures are estimated to be 130 parts per billion (ppb) for surface water and 1.5 ppb for ground water. The EECs for chronic exposures are estimated to be 16 ppb for surface water and 1.5 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 130 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration value of 16 ppb was used to assess the contribution to drinking water.

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

Sethoxydim is currently registered for use on the following residential non-dietary sites: Ornamentals and flowering plants, recreational areas, rights-of-way, along fences and hedgerows, and public and commercial buildings/structures (non-agricultural-outdoors). The risk assessment was conducted using the following residential exposure assumptions: Homeowners who apply sethoxydim to ornamental gardens and turf may be exposed for short-term (up to 30 days) durations via the dermal and inhalation routes. Short-term post application exposures to children may result from incidental oral contact via hand-to-mouth, turf-to-mouth, and soil-to-mouth activities with treated turf. No dermal toxicity endpoints were identified, therefore, only exposure from inhalation (adult handlers) and incidental ingestion (children) were assessed. For short-term and intermediate-term aggregate exposure, the inhalation exposures estimated for adult handlers cannot be combined with dietary exposure due to lack of common toxicity via the oral [transitory clinical signs: Irregular gait at doses of 650 milligrams/kilogram (mg/kg) and 1,000 mg/kg and inhalation (hepatotoxicity)] routes of exposure. Therefore, only short-term aggregate exposures from incidental ingestion for children via hand-to-mouth, turf-to-mouth, and soil-to-mouth activities with treated turf were assessed.

4. Cumulative effects from substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) of the 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 sethoxydim and any other substances and sethoxydim 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 sethoxydim 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 website at http://www.epa.gov/pesticides/cumulative .

1. In general . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base 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 safety factors, as appropriate.

2. Prenatal and postnatal sensitivity . Since there is evidence of increased susceptibility of the young following exposure to sethoxydim in the rat developmental study and the rat reproduction study, the EPA performed a Degree of Concern Analysis to: 1. Determine the level of concern for the effects observed when considered in the context of all available toxicity data; and 2. Identify any residual uncertainties after establishing toxicity endpoints and traditional uncertainty factors to be used in the risk assessment of this chemical. If residual uncertainties are identified, EPA examines whether these residual uncertainties can be addressed by a special FQPA safety factor and, if so, the size of the factor needed. The results of Degree of Concern analysis for sethoxydim are presented as follows:

The degree of concern is low for the fetal effects in the developmental rat study since the fetal anomalies were seen only at the high dose (650 mg/kg/day) which is close to the Limit Dose (1,000 mg/kg/day), they were seen in the presence of maternal toxicity (irregular gait) and clear NOAELs/LOAELs were established for maternal and developmental toxicities.

EPA has determined that the degree of concern was low for prenatal and/or postnatal toxicity resulting from exposure to sethoxydim toxicity.

3. Conclusion. In the final rule published in the Federal Register of September 29, 2003 (68 FR 55858) (FRL-7328-6) ( http://www.epa.gov/EPA-PEST/2003/September/Day-29/p24562.htm ). EPA retained the additional 10X FQPA safety factor in the form of a Data base Uncertainty Factor because EPA had required submission of subchronic and developmental neurotoxicity studies due to various clinical signs in the rat developmental study and evidence of developmental abnormalities in the rat developmental and reproductive studies. In December of 2004, the EPA revisited the requirement for the subchronic and developmental neurotoxicity studies and determined that the evidence does not support the need for neurotoxicity studies for the reasons discussed below.

First, EPA concluded that the clinical signs seen in the rat developmental study were not neurotoxicity. The clinical signs following sethoxydim exposure in that study were irregular gait, decreased activity, excessive salivation, and anogenital staining. These effects were only observed in animals receiving very high doses of sethoxydim (650 mg/kg/day and 1,000 mg/kg/day). Irregular gait was observed in 12/24 dams at 650 mg/kg/day and 10/10 dams at 1,000 mg/kg/day on the first day of dosing, after 3 doses the signs began to dissipate. Decreased activity was noted in 1/34 dams at 650 mg/kg/day and in 4/10 dams at 1,000 mg/kg/day and reversed after several days. Excessive salivation was noted in 23/34 dams at 650 mg/kg/day and 10/10 dams at 1,000 mg/kg/day. Anogenital staining was documented in 13/34 dams at 650 mg/kg/day and 7/10 dams at 1,000 mg/kg/day. All clinical signs reported were transient, with the exception of the anogenital staining which did not reverse. Because the clinical signs occurred shortly after dosing, only occurred at very high treatment doses (over one half the limit dose) and were transitory, it is unlikely that the signs observed are the result of a primary systemic effect on the nervous system but, rather, are reflective of the general toxicity at the high dose. It should be noted that clinical signs indicative of nervous system effects were not observed in any other standard toxicity study for sethoxydim. Although none of these other studies dosed up to 650 and 1,000 mg/kg/day, a maximum tested dose was reached because of evidence of other toxicities (e.g., liver effects or body weight reductions).

Second, EPA found that there were no developmental effects seen in the rat and rabbit prenatal studies indicative of an effect on the nervous system. The main effect seen in the rat and rabbit prenatal studies was an increased incidence of fetal skeletal variations due to delayed ossification. In the rat prenatal study, tail abnormalities (filamentous tail or lack of a tail) were noted. These abnormalities were observed at a very low incidence (10 fetuses in 7 litters, 650 milligrams/kilogram/body weight/day (mg/kg/bwt/day and at high treatment doses (650 and 1,000 mg/kg/day). In the 2-generation reproduction study in rat, a tail anomaly (short, thread-like tail, no anal opening, hindlimbs curved toward central midline) was found in one pup in the F2b generation (1/344 total pups; in 1/4 litters). Tail abnormalities are sometimes thought to relate to central nervous system (CNS) malformations; however, in this case, these tail abnormalities are not likely to be the result of a primary neurotube effect. In the rat prenatal study, there is no description of any effect on neural tube derived structures. Furthermore, the class of compounds, cyclohexones (which sethoxydim is a member), do not demonstrate neurotoxicity or developmental malformations of the nervous system.

Therefore, after a weight-of-evidence examination of all the toxicological studies available in the data base, the previous requirement for a neurotoxicity studies have been waived.

In light of its finding that neurotoxicity studies are not needed, EPA has now determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings:

1. The toxicity database for sethoxydim is complete.

2. There is no indication that sethoxydim is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity.

3. Although there is qualitative evidence of increased susceptibility in the prenatal developmental studies in rats and rabbits, the risk assessment team did not identify any residual uncertainties after establishing toxicity endpoints and traditional uncertainty factors to be used in the risk assessment for sethoxydim. The degree of concern for pre-and/or postnatal toxicity is low.

4. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on tolerance level residues and 100 PCT for all proposed new uses and for all commodities in Vegetable, root and tuber, group 1. For most of the remaining crops available maximum PCT treated values were used for acute dietary assessment and average PCT values were assumed for chronic dietary assessment. Tolerance level residues were assumed for crops with existing tolerances or anticipated residues were calculated through the incorporation of field trial data. Conservative ground and surface water modeling estimates were used. Similarly conservative Residential SOPs were used to assess post-application exposure to children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by sethoxydim.

Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (“aPAD”) and chronic population adjusted dose (“cPAD”). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (“MOE”) called for by the product of all applicable uncertainty/safety factors is not exceeded.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to sethoxydim will occupy 11% of the aPAD for the U.S. population, 7.2% of the aPAD for females 13 years and older, 14% of the aPAD for all infants ( < 1 year old), and 20% of the aPAD for children 1-2 years old, the subpopulation at greatest exposure

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to sethoxydim from food and water will utilize 6.9% of the cPAD for the U.S. population, 15% of the cPAD for all infants ( < 1 year old), and 16% of the cPAD for children 1-2 years old, the subpopulation at greatest exposure. Based on the use pattern, chronic residential exposure to residues of sethoxydim is not expected.

3. Short-term risk . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Sethoxydim is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for sethoxydim.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food, water and residential exposures aggregated result in aggregate MOEs of 5,700 for children/toddlers 1-2 years of age. Since this is the subpopulation with the highest estimated food and water exposures and the calculated MOE of 5,700 is substantially greater than the target MOE of 100 EPA has no concern for short-term aggregate risk for other subpopulations as well.

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

Though residential exposure could occur with the use of sethoxydim intermediate-term exposures are not expected. Only risks associated with short-term exposures of up to 30 days were assessed.

5. Aggregate cancer risk for U.S. population . The Agency has classified sethoxydim as not likely to be a human carcinogen based on lack of evidence of carcinogenicity in rats and mice. Sethoxydim is not expected to pose a cancer risk.

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 sethoxydim residues.

Adequate enforcement methodology (gas-liquid chromatography with flame photometric detection in the sulfur mode) is available BASF Wyandotte Corporations' (BWCs) Method No. 30, 3/15/82; MRID 44864501; Method I, PAM II to enforce the tolerance expression for the purpose of this request.

There are currently no Codex maximum residue levels for sethoxydim.

Therefore, the tolerance is established for combined residues of sethoxydim {2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one}and its metabolites containing the 2-cyclohexen-1-one moiety (calculated as sethoxydim), in or on buckwheat, grain at 19 ppm; buckwheat, flour at 25 ppm; okra at 2.5 ppm; borage, seed at 6.0 ppm; borage, meal at 10 ppm; dillweed, fresh leaves at 10 ppm; radish, tops at 4.5 ppm; turnip, greens at 5.0 ppm and vegetable, root and tuber, group 1 at 4.0 ppm.

This final rule establishes a tolerance under section 408(d) of FFDCA 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 rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). 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); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, 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. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• 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 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr .

Under section 408(g) of FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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-2006-0205 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before April 30, 2007.

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 that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0205, by one of the following methods:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• 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.

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr .

Under section 408(g) of FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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-2007-0010 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before April 30, 2007.

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 that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2007-0010, by one of the following methods:

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line instructions for submitting comments.

• Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

• Delivery : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is (703) 305-5805.

In the Federal Register of July 27, 2005 (70 FR 43421) (FRL-7727-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5F 6957) by ISAGRO S.p.A., Centro Uffici S. Siro — Fabbricato D — ALA 3, Via Caldera, 21, 20153 Milano, Italy. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of the herbicide orthosulfamuron in or on rice, grain and rice, straw at 0.05 ppm. That notice referenced a summary of the petition prepared by ISAGRO S.p.A., Centro Uffici S. Siro — Fabbricato D — ALA 3, Via Caldera, 21, 20153 Milano, Italy, the registrant, that is included in the public docket. There were no 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....”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .

Consistent with section 408(b)(2)(D) of FFDCA, 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 section 408(b)(2) of FFDCA, for a tolerance for residues of orthosulfamuron in or on rice, grain and rice, straw at 0.05 ppm. 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. Specific information on the studies received and the nature of the toxic effects caused by orthosulfamuron 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 0002 (pages 38-44) in docket ID number EPA-HQ-OPP-2007-0010.

For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at http://docket.epa.gov/edkpub/index.jsp .

A summary of the toxicological endpoints for orthosulfamuron used for human risk assessment can be found at http://www.regulations.gov in document 2 (pages 19-20) in docket ID number EPA-HQ-OPP-2007-0010.

1. Dietary exposure from food and feed uses . Risk assessments were conducted by EPA to assess dietary exposures from orthosulfamuron 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 orthosulfamuron; therefore, a quantitative acute dietary exposure assessment was not performed.

ii. Chronic exposure . In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The chronic analysis is based on tolerance level residues and 100% of the crop treated.

iii. Cancer . Orthosulfamuron is classified as demonstrating “suggestive evidence of carcinogenicity” based on thyroid follicular cell adenomas observed in male rats. The Agency has concluded that quantification of human cancer risk is not warranted and the NOAEL selected for the chronic reference dose (cRfD) is protective of cancer effects.

iv. Anticipated residue and percent crop treated (PCT) information . The chronic dietary exposure analysis was based on tolerance level residues and 100 PCT assumptions.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for orthosulfamuron in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of orthosulfamuron. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://docket.epa.gov/edkpub/index.jsp

Based on the interim rice model and screening concentration in groundwater (SCI-GROW) models, the estimated environmental concentration (EECs) of orthosulfamuron in drinking water for chronic exposures is estimated to be 40.5 parts per billion (ppb) for surface water and 0.611 ppb for groundwater.

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).

Orthosulfamuron is not registered for use on any sites 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.”

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 orthosulfamuron and any other substances and orthosulfamuron 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 orthosulfamuron 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 website at http://www.epa.gov/pesticides/cumulative .

1. In general . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the 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. 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 UFs and/or special FQPA safety factors, as appropriate.

2. Prenatal and postnatal sensitivity . There is no concern for increased quantitative and/or qualitative susceptibility after exposure to orthosulfamuron in developmental toxicity studies in rats and rabbits, or a reproduction study in rats. In the developmental studies, there was no treatment-related maternal or developmental toxicity observed. In the reproduction study, decreased motor activity was seen in 6-week old males (F1) at 354.5 milligrams/kilograms/day (mg/kg/day). However, the offspring effects were observed in the presence of maternal toxicity (kidney lesions), seen in adult females of both generations (F0 and F1). The NOAEL (5 mg/kg/day) selected for the cRfD is lower (70X) than the dose at which the motor activity was observed and; thus, considered protective of the effects.

3. Conclusion . EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings:

i. The toxicity database for orthosulfamuron is complete.

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

iii. There is no evidence that orthosulfamuron results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

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. Conservative groundwater and surface water modeling estimates were used. Similarly conservative. These assessments will not underestimate the exposure and risks posed by orthosulfamuron.

1. Acute risk . Review of applicable toxicity studies indicated that orthosulfamuron is not expected to pose an acute risk.

2. Short-term risk . Orthosulfamuron is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC.

3. Intermediate-term risk . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be background exposure level).

Orthosulfamuron is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC.

4. Chronic risk . EPA considers chronic aggregate risk to consist of risks resulting from exposure to residues in food, drinking water, and residues resulting from residential applications. As there are no residential uses for orthosulfamuron, chronic aggregate risk consists of risks resulting from exposure to residues in food and drinking water alone, which do not exceed the Agency's LOC.

5. Aggregate cancer risk for U.S. population . The long-term chronic risk assessment outlined in this unit is considered to be protective of cancer effects.

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 orthosulfamuron residues.

An adequate high performance liquid chromatography-mass spectrometry analytical method for enforcement purposes is available. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft Meade, Maryland 20755-5350. Telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

No Codex maximum residue limits (MRLs) have been established for residues of orthosulfamuron on any crops at this time.

Therefore, the tolerance is established for residues of orthosulfamuron, in or on rice, grain and rice, straw at 0.05 ppm.

This final rule establishes a tolerance under section 408(d) of FFDCA 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 rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). 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); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, 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. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

The Congressional Review Act, 5 U.S.C. 801 et seq. , generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Migratory birds are of great ecological and economic value and are an important international resource. They are a key ecological component of the environment, and they also provide immense enjoyment to millions of Americans who study, watch, feed, or hunt them. Recognizing their importance, the United States has been an active participant in the internationally coordinated management and conservation of migratory birds. The Migratory Bird Treaty Act (16 U.S.C. 703-712) (MBTA) is the primary legislation in the United States established to conserve migratory birds. The U.S. Fish and Wildlife Service (Service), is the Federal agency within the United States responsible for administering and enforcing the statute.

The MBTA, originally passed in 1918, implements the United States' commitment to four bilateral treaties, or conventions, for the protection of a shared migratory bird resource. The original treaty upon which the MBTA was based was the Convention for the Protection of Migratory Birds, signed with Great Britain in 1916 on behalf of Canada for the protection “of the many species of birds that traverse certain parts of the United States and Canada in their annual migration.” The MBTA was subsequently amended after treaties were signed with Mexico (1936, amended 1972, 1997), Japan (1972), and Russia (1976), and the amendment of the treaty with Canada (1995).

While the terms of the treaties vary in their particulars, each treaty and subsequent amendments impose substantive obligations on the United States for the conservation of migratory birds and their habitats. For example, the Canada treaty, as amended, includes the following conservation principles:

• To manage migratory birds internationally;

• To ensure a variety of sustainable uses;

• To sustain healthy migratory bird populations for harvesting needs;

• To provide for, maintain, and protect habitat necessary for the conservation of migratory birds; and

• To restore depleted populations of migratory birds.

The Canada and Mexico treaties protect selected families of birds, while the Japan and Russia treaties protect selected species of birds. All four treaties provide for closed seasons for hunting game birds. The list of the species protected by the MBTA appears in title 50, section 10.13, of the Code of Federal Regulations (50 CFR 10.13).

Under the MBTA, it is unlawful “by any means or in any manner, to pursue, hunt, take, capture, [or] kill” any migratory birds except as permitted by regulation (16 U.S.C. 703). The Secretary is authorized and directed, from time to time, having due regard to the zones of temperature and to the distribution, abundance, economic value, breeding habits, and times and lines of migratory flight of such birds to adopt suitable regulations permitting and governing the take of migratory birds when determined to be compatible with the terms of the treaties (16 U.S.C. 704). Furthermore, the regulations at 50 CFR 21.11 prohibit the take of migratory birds except under a valid permit or as permitted in the implementing regulations. The Service has defined “take” in regulation to mean to “pursue, hunt, shoot, wound, kill, trap, capture, or collect” or to attempt these activities (50 CFR 10.12).

On July 18, 2000, the United States Court of Appeals for the District of Columbia ruled in Humane Society v. Glickman, 217 F.3d 882 (D.C. Cir. 2000), that Federal agencies are subject to the take prohibitions of the MBTA. The United States had previously taken the position, and two other courts of appeals held or suggested, that the MBTA does not by its terms apply to Federal agencies. See Sierra Club v. Martin, 110 F.3d 1551, 1555 (11th Cir. 1997); Newton County Wildlife Ass'n v. U.S. Forest Service, 113 F.3d 110, 115 (8th Cir. 1997). Subsequently, on December 20, 2000, we issued Director's Order 131 to clarify the Service's position that, pursuant to Glickman, Federal agencies are subject to the permit requirements of the Service's existing regulations.

Because the MBTA is a criminal statute and does not provide for citizen-suit enforcement, a private party who violates the MBTA is subject to investigation by the Service and/or prosecution by the Department of Justice. However, the Administrative Procedure Act (5 U.S.C. 551 et seq.) (APA) allows private parties to file suit to prevent a Federal agency from taking “final agency action” that is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law” (5 U.S.C. 706(2)(A)). If the prohibitions of the MBTA apply to Federal agencies, private parties could seek to enjoin Federal actions that take migratory birds, unless such take is authorized pursuant to regulations developed in accordance with 16 U.S.C. 704, even when such Federal actions are necessary to fulfill Government responsibilities and even when the action poses no threat to the species at issue.

In Center for Biological Diversity v. Pirie, a private party obtained an injunction prohibiting live-fire military training exercises of the Department of the Navy that had the effect of killing some migratory birds on the island of Farallon de Medinilla (FDM) in the Pacific Ocean. On March 13, 2002, the United States District Court for the District of Columbia ruled that the Navy activities at FDM resulting in a take of migratory birds without a permit from the Service violated the MBTA and the APA (191 F. Supp. 2d. 161 and 201 F. Supp. 2d 113). On May 1, 2002, after hearing argument on the issue of remedy, the Court entered a preliminary injunction ordering the Navy to apply for a permit from the Service to cover the activities, and preliminarily enjoined the training activities for 30 days. The United States Court of Appeals for the District of Columbia Circuit stayed the District Court's preliminary injunction pending appeal. The preliminary injunction, and associated stay, expired on May 31, 2002. A permanent injunction was issued by the District Court on June 3, 2002. The Circuit Court also stayed this injunction pending appeal on June 5, 2002. On December 2, 2002, the President signed the Authorization Act creating an interim period during which the prohibitions on incidental take of migratory birds would not apply to military readiness activities. During the interim period, Congress also directed the Secretary of the Interior to develop regulations that exempt the Armed Forces from incidental take during authorized military readiness activities. The Department of Defense must concur with the regulations before they take effect. The Circuit Court subsequently dismissed the Pirie case as moot. In light of the Glickman and Pirie decisions, the authorization that this rule provides is essential to preserving the Service's role in determining what military readiness activities, if any, create an unacceptable risk to migratory bird resources and therefore must be modified or curtailed.

The Armed Forces are responsible for protecting the United States from external threats. To provide for national security, they engage in military readiness activities. “Military readiness activity” is defined in the Authorization Act to include all training and operations of the Armed Forces that relate to combat, and the adequate and realistic testing of military equipment, vehicles, weapons, and sensors for proper operation and suitability for combat use. It includes activities carried out by contractors, when such contractors are performing a military readiness activity in association with the Armed Forces, including training troops on the operation of a new weapons system or testing the interoperability of new equipment with existing weapons systems. Military readiness does not include (a) the routine operation of installation operating support functions, such as: administrative offices; military exchanges; commissaries; water treatment facilities; storage facilities; schools; housing; motor pools; laundries; morale, welfare, and recreation activities; shops; and mess halls, (b) the operation of industrial activities, or (c) the construction or demolition of facilities listed above.

Section 315 of the 2003 National Defense Authorization Act (Pub. L. 107-314, 116 Stat. 2458, Dec. 2, 2002, reprinted in 16 U.S.C. 703 note) (hereinafter “Authorization Act”) requires the Secretary of Defense, in consultation with the Secretary, to identify ways to minimize, mitigate, and monitor take of migratory birds during military readiness activities and requires the Secretary to prescribe, with the concurrence of the Secretary of Defense, a regulation that exempts military readiness activities from the MBTA's prohibitions against take of migratory birds. With the passage of the Authorization Act, Congress determined that such regulations are consistent with the MBTA and the underlying treaties by requiring the Secretary to promulgate such regulations. Furthermore, Congress clearly expressed its intention that the Armed Forces give appropriate consideration to the protection of migratory birds when planning and executing military readiness activities, but not at the expense of diminishing the effectiveness of such activities. Any diminishment in effectiveness could impair the ability of the Armed Forces to fulfill their national security mission. Diminishment could occur when military training or testing is modified in ways that do not allow the full range of training methods to be explored.

This rule authorizes the Armed Forces to take migratory birds incidental to military readiness activities, subject to certain limitations and subject to withdrawal of the authorization to ensure consistency with the provisions of the migratory bird treaties. The authorization provided by this rule is necessary to ensure that the work of the Armed Forces in meeting their statutory responsibilities can go forward. This rule is also appropriate and necessary to ensure compliance with the treaties and to protect a vital resource in accordance with the Secretary's obligations under Section 704 of the MBTA as well as under Section 315 of the Authorization Act. This rule will continue to ensure conservation of migratory birds as the authorization it provides is dependent upon the Armed Forces conferring and cooperating with the Service to develop and implement conservation measures to minimize or mitigate significant adverse effects to migratory birds. This rule has been developed by the Service in coordination and cooperation with the Department of Defense, and the Secretary of Defense concurs with the requirements herein.

Migratory bird conservation relative to activities of the Department of Defense and the Coast Guard other than military readiness activities are addressed separately in Memoranda of Understanding (MOUs) developed in accordance with Executive Order 13186, Responsibilities of Federal Agencies to Protect Migratory Birds, signed January 10, 2001. The MOU with the Department of Defense was published in the Federal Register August 30, 2006 (Volume 71, Number 168). Upon completion of the MOUs with additional Federal agencies, and in keeping with the intent of the Executive Order for Federal agencies to promote the conservation of migratory bird populations, the Service may issue incidental take authorization to address specific actions identified in the MOUs.

On June 2, 2004, we published in the Federal Register (69 FR 31074) a proposed rule to authorize the take of migratory birds, with limitations, that result from Department of Defense military readiness activities. We solicited public comment on the proposed rule for 60 days ending on August 2, 2004.

By this date, we received 573 comments in response to the proposed rule; 24 were from identified organizations or agencies. The following text discusses the substantive comments received and provides our response to those comments. Additionally, it provides an explanation of significant changes from the proposed rule. We do not specifically address the comments that simply opposed the rule unless they included recommendations for revisions. Comments are organized by topic.

To more closely track the language in the Authorization Act and to clarify that the rule applies to the incidental taking of a migratory bird by a member of the Armed Forces during a military readiness activity, we have replaced the “Department of Defense” with “Armed Forces,” where applicable.

Comment: The statement that the rule allows take only in “narrow instances” of military readiness activities goes against the spirit and letter of the MBTA, which forbids the take of migratory birds and thus abrogates the MBTA.

Service Response: The MBTA regulates, rather than absolutely forbids, take of migratory birds. The Secretary is authorized and directed, from time to time, having due regard to the zones of temperature and to the distribution, abundance, economic value, breeding habits, and times and lines of migratory flight of such birds to adopt suitable regulations permitting and governing the take of migratory birds when determined to be compatible with the terms of the treaties (16 U.S.C. 704). In the Authorization Act, Congress directed the Secretary to utilize his/her authority to permit incidental take for military readiness activities. Furthermore, Congress itself by passing the Authorization Act determined that allowing incidental take of migratory birds as a result of military readiness activities is consistent with the MBTA and the treaties. Thus, this rule does not abrogate the MBTA.

Comment: Citing broad take authorization language in the current text of the treaty with Canada, concern was expressed regarding the analysis in the proposed rule that the treaty with Canada has a narrower focus than the treaties with Japan and Russia.

Service Response: We agree with the commenter that the Canada treaty, as amended by the 1995 Protocol, now includes broad exception language similar to that in the Japan and Russia treaties. We have expanded upon and added additional clarification in the section “Is the rule consistent with the MBTA?” discussing compatibility of this rule with the MBTA and the four treaties.

Comment: The Department of Defense should avoid take of migratory birds by avoiding areas inhabited by migratory birds including restricting construction and active use of airfields in the vicinity of wildlife refuges, prohibiting military operations over wildlife refuges or sensitive migratory bird habitat areas, and avoiding areas where migratory birds nest, breed, rest, and feed.

Service Response: Military lands often support a diversity of habitats and their associated species, including migratory birds; thus it would be difficult for the Armed Forces to completely avoid areas inhabited by birds or other wildlife species. When determining the location for a new installation, such as an airfield, the applicable Armed Force must prepare environmental documentation in accordance with the National Environmental Policy Act (42 U.S.C. 4321 et seq.) (NEPA) that gives due consideration to the impacts of the proposal on the environment, including migratory birds. With respect to wildlife refuges, Congress in the 2000 amendments to the National Wildlife Refuge System Administration Act noted specifically that the provisions of the Act relating to determinations of the compatibility of a use would not apply to overflights above a refuge (Pub. L. 106-580; December 29, 2000). Nevertheless, as noted in this rule, the Armed Forces have made significant investments in acquiring data on the distribution of bird populations and identification of migration routes, as well as the use of military lands for breeding, stopover sites, and over-wintering areas, to protect and conserve these areas. The Armed Forces actively utilize radar ornithology to plan new construction and testing and training operations in areas and times of least constraints. The Armed Forces also have a strong interest in avoiding bird/aircraft conflicts and use this type of information to assist range planners in selecting training times when bird activity is low.

In accordance with the Sikes Act (included in Pub. L. 105-85), the Department of Defense must provide for the conservation and rehabilitation of natural resources on military installations. Thus, potential conflicts with natural resources, including migratory birds, should be addressed in Integrated Resource Management Plans (INRMP), where applicable. Although the Sikes Act does not apply to the Coast Guard, they are also starting to encourage applicable bases to develop INRMPs.

Comment: Provision should be included that the Department of Defense cannot ignore scientific evidence and proceed on a course of action where take is inevitable.

Service Response: None of the four treaties strictly prohibit the taking of migratory birds without exception. Furthermore, the Service acknowledges that regardless of the entity implementing an activity, some birds may be killed even if all reasonable conservation measures are implemented. With the passage of the Authorization Act, Congress directed the Secretary to authorize incidental take by the Armed Forces. Thus, they will be allowed to take migratory birds as a result of military readiness activities, consistent with this rule. This rule, however, will continue to ensure conservation of migratory birds as it requires the Armed Forces to confer and cooperate with the Service to develop and implement conservation measures to minimize or mitigate adverse effects to migratory birds when scientific evidence indicates an action may result in a significant adverse effect on a population of a migratory bird species.

As stated in the Principles and Standards section of this rule, the Armed Forces will use the best scientific data available to assess through the NEPA process, or other environmental requirements, the expected impact of proposed or ongoing military readiness activities on migratory bird species likely to occur in the action areas.

Comment: The Department of Defense should not have the sole authority/responsibility to determine whether the survival of the species is threatened, and only then initiate consultation with the Service.

Service Response: We assume that, despite the commenter's use of the term “consultation”, this is a reference to the requirement under § 21.15(a)(1) to “confer and cooperate,” and not to the requirement of “consultation” under section 7 of the Endangered Species Act (ESA), 16 U.S.C. 1536. Section 21.15(a)(1) does condition the requirement to “confer and cooperate” on a determination by the Armed Forces that a military readiness activity may result in a significant adverse effect on a population of a migratory birds species. However, we expect that the Armed Forces will notify the Service of any activity that even arguably triggers this requirement. In addition, putting aside the requirements of this regulation, the Armed Forces would, as a matter of course share such information in a number of circumstances.

First, NEPA, and its regulations at 40 CFR 1500-1508, require that Federal agencies prepare environmental impact statements for “major Federal actions significantly affecting the quality of the human environment.” These statements must include a detailed analysis of the impacts of an agency's proposed action and any reasonable alternatives to that proposal. NEPA also requires the responsible Federal official to “consult with and obtain comments of any Federal agency which has jurisdiction by law or special expertise with respect to any environmental impact involved.”

Second, the Sikes Act (16 U.S.C. 670a-670o), as amended in 1997, requires the development of INRMPs by the Department of Defense that reflect the mutual agreement of the Department of Defense, the Service, and the appropriate State wildlife agency. The Sikes Act has provided the Service, as well as the public, with an opportunity to review natural resources management on military lands, including any major conflicts with migratory birds or their habitat. NEPA documentation is also completed on new or revised INRMPs. Department of Defense policy requires installations to review INRMPs annually in cooperation with the Service and State resource agencies. Annual reviews facilitate adaptive management by providing an opportunity for the parties to review the goals and objectives of the plans and to evaluate any new scientific information that indicates the potential for adverse impacts on population of a migratory bird species from ongoing (or new) military readiness activities.

Third, if the military readiness activity may affect a species listed under the ESA, the Armed Forces would communicate with the Service to determine whether formal consultation is necessary under section 7 of the ESA.

If, as a result these formal processes or by any other mechanism the Service obtains information which raise concerns about the impacts of military readiness on migratory bird populations, the Service can request additional information from the Armed Services. Under section 21.15(b)(2)(iii), failure to provide such information can form the basis for withdrawal of the authorization to take migratory birds. In any case, based on this information, the Service can, under appropriate circumstances, suspend or withdraw the authorization even if the Armed Forces do not themselves determine that a military readiness activity may result in a significant adverse effect on a population of a migratory bird species.

Comment: The threshold for requiring the Department of Defense to confer with the Service when a “significant adverse effect on the sustainability of a population of migratory bird species of concern” is too high. This could allow significant damage to resources that could be avoided with criteria that are more stringent.

Service Response: We agree. We have modified the threshold to “significant adverse effect on a population of migratory bird species.” The definitions of “population” and “significant adverse effect” have also been modified accordingly in this rule.

Comment: The provision that the rule must be promulgated with the concurrence of the Secretary of Defense requires the regulator to get permission of the regulated agency.

Service Response: The 2003 Defense Authorization Act required that the regulation be developed with the concurrence of the Secretary of Defense. However, as indicated in § 21.15(b), we have the authority to withdraw authorization if it is determined that a proposed military readiness activity may be in violation of any of the migratory bird treaties or otherwise is not being implemented in accordance with this regulation.

Comment: Encourage more emphasis on upfront planning and evaluation of minimum-impact alternatives to foster more opportunities to avoid or mitigate impacts.

Service Response: As stated in this rule, the Department of Defense currently incorporates a variety of conservation measures into their INRMP documents to address migratory bird conservation. Additional measures will be developed in the future with all the Armed Forces in coordination with the Service and implemented where necessary to avoid, minimize, or mitigate significant adverse effects on migratory bird populations. This rule also indicates the Armed Forces shall engage in early planning and scoping and involve agencies with special expertise in the matters related to the potential impacts of a proposed action.

Comment: The proposed rule grants the Department of Defense greater authority to take and kill migratory birds than authorized in the Defense Authorization Act, which is the only statutory authority for the proposed rule and requires that the Department of Defense minimize and mitigate impacts to migratory birds.

Service Response: We do not agree that the rule provides greater authority to take birds than authorized in the Defense Authorization Act. What this rule does is provide clarity regarding the processes the Armed Forces are required to initiate to minimize and mitigate adverse impacts of authorized military readiness activities on migratory birds while ensuring compliance with the migratory bird treaties and meeting the Secretary's obligations under Section 704 of the MBTA.

Comment: The rule should require mitigation options be formally assessed and evaluated prior to undertaking the activity and that mitigation be commensurate with the extent of the impact.

Service Response: We agree that mitigation can be very complex both from the perspective of replicating all the ecosystem components that a species needs to successfully survive and reproduce regardless of whether mitigation is ex-situ or in-situ.

The Service's Mitigation Policy (Fish and Wildlife Service Manual, 501 FW 2) is designed to assist the Service in the development of consistent and effective recommendations to protect and conserve valuable fish and wildlife resources to help ensure that mitigation be commensurate with the extent of the impact.

In addition, as indicated in this rule, the Armed Forces will confer and cooperate with the Service to develop and implement conservation measures when an ongoing or proposed activity may have a significant adverse effect on a population of migratory bird species. The public, and the Service, also have the opportunity to review and comment on proposed military readiness activities in accordance with NEPA.

Comment: Section 21.15(a) of the proposed regulation must be revised to provide a system of oversight by the Service both in determining whether Department of Defense military readiness activities would likely adversely impact a migratory bird population and in setting a timeline for the implementation of conservation measures.

Service Response: As previously indicated, the Service and the public have the opportunity to review and comment on proposed military readiness activities in accordance with NEPA or other environmental review. Thus, we will be provided an opportunity to evaluate whether a proposed activity may have an adverse effect on migratory bird populations.

Comment: Pursuant to authority granted by 10 U.S.C. 101 and 14 U.S.C. 1, the U.S. Coast Guard is a branch of the armed forces of the USA at all times. Under this authority, the Coast Guard engages in military readiness activities. Furthermore, under the definition of “Secretary of Defense,” the Department of Homeland Security is included with respect to military readiness activities of the U.S. Coast Guard. The rule should be revised accordingly to reflect this.

Service Response: Section 315 of the Authorization Act provides for the Secretary “to prescribe regulations to exempt the Armed Forces for the incidental taking of migratory birds during military readiness activities authorized by the Secretary of Defense or the Secretary of the military department concerned.” We agree that “Armed Forces” includes the Coast Guard.

Comment: In order for potential impacts of the implementation of this rule to be effectively analyzed, the rule should not be categorically excluded. A full NEPA analysis should be conducted for the rule.

Service Response: Because of the broad spectrum of activities, activity locations, habitat types, and migratory birds potentially present that may be affected by this rule, it is not foreseeable or reasonable to anticipate all the potential impacts in a meaningful manner of military readiness activities conducted by the Armed Forces on the affected environment; thus it is premature to examine potential impacts of the rule in accordance with NEPA. We have determined that any environmental analysis of the rule would be too broad, speculative, and conjectural.

Part 516 Departmental Manual 2.3 A (National Environmental Policy Act Part 1508.4) allows an agency (Bureau) in the Department of Interior to determine if an action is categorically excluded from NEPA. We have made the determination that the rule is categorically excluded in accordance with 516 Departmental Manual 2, Appendix 1.10. This determination does not diminish the responsibility of the Armed Forces to comply with NEPA. Whenever the Armed Forces propose to undertake new military readiness activities or to adopt a new, or materially revised, INRMP where migratory bird species may be affected, the Armed Forces invite the Service to comment as an agency with “jurisdiction by law or special expertise” upon their NEPA analysis. In addition, if the potential for significant effects on migratory birds makes it appropriate, the Armed Forces may invite the Service to participate as a cooperating agency in the preparation of their NEPA analysis. Moreover, authorization under this rule requires that if a proposed military readiness activity may result in a significant adverse impact on a population of migratory bird species, the Armed Forces must confer and cooperate with the Service to develop and implement appropriate measures to minimize or mitigate these effects. The environmental consequences of the proposed military readiness activity, as well as the potential of any such measures to reduce the adverse impacts of the proposed activity, would be covered in NEPA documentation prepared for the proposed action.

Comment: Section 21.15(a) of the proposed regulation is unclear as to who is to determine that ongoing or proposed activities are likely to result in significant adverse effects.

Service Response: We have revised § 21.15(a) to clarify that this responsibility initially lies with the action proponent, i.e., the Armed Forces. Just as the Armed Forces make the initial determination that consultation is required under similar statutes, such as the Endangered Species Act (16 U.S.C. 1531 et seq.) (ESA) or the National Historic Preservation Act (16 U.S.C. 470), the action proponent will consider the likely effects of its proposed action and whether such effects require that it confer with the Service to develop and implement appropriate conservation measures to minimize or mitigate potential significant adverse effects. Where significant adverse impacts are likely, existing requirements under NEPA for federal agencies to prepare environmental documentation will ensure that both the public and the Service have an opportunity to review a proposed action and the Armed Force's determination with respect to migratory birds.

The Service and State wildlife agencies (and the general public if plan revisions are proposed) also have an opportunity to review the Department of Defense's management of installation natural resources, including the impacts of land use on such resources, during the quintennial review of INRMPs for Department of Defense lands. Consultation under the Endangered Species Act offers yet another opportunity for the Service to provide input on the potential effects of a proposed military readiness activity on federally listed migratory birds.

Comment: The document uses both the terms “may” affect migratory birds and “likely” to affect migratory birds. “May” should be used to be consistent with the NEPA threshold for impacts on the environment.

Service Response: The Service has intentionally established different standards for when the Armed Forces are required to confer with the Service and for when we may propose withdrawal of authorization. We have established a broad standard for triggering when the Armed Forces must notify the Service of potential adverse effects on migratory birds. We agree that requiring the Armed Forces to confer with the Service when applicable activities “may” result in a significant adverse effect is consistent with the analysis threshold utilized in NEPA. The Secretary determined that the more restrictive threshold of suspending or withdrawing authorization was warranted when a military readiness activity likely would not be compatible with one or more of the treaties or is likely to result in a significant adverse effect on a migratory bird population.

Comment: The Department of Defense is given too much decision power in the rule. Concern was expressed that the final decision regarding whether a military readiness activity is authorized or not is made by political appointees rather than unbiased career employees.

Service Response: Our political system is based upon a structure whereby policy decisions are made by political appointees rather than career employees. To address what may be perceived as too much power by the Armed Forces, it is the Secretary of the Interior who has, and retains, the final determination regarding whether an activity is authorized under the MBTA, not the Secretary of Defense.

Comment: The rule should require sufficient monitoring to detect significant impacts and provide for diligent oversight by the Department of the Interior to head off problems well before jeopardy is near and withdrawal of authorization is suspended or proposed to be withdrawn.

Service Response: We concur that monitoring can play a key role in providing valuable data needed to evaluate potential impacts of activities, inform conservation decisions, and evaluate effectiveness of conservation measures. For monitoring to be relevant, it should focus on specific objectives, desired outcomes, key hypotheses, and conservation measures. As stated in § 21.15(b)(2)(ii) of the rule, in instances where it is appropriate, the Armed Forces are required to “conduct mutually agreed upon monitoring to determine the effects of military readiness activity on migratory bird species and/or the efficacy of the conservation measures implemented by the Armed Forces.” This rule also states that the Armed Forces will consult with the Service to identify techniques and protocols to monitor impacts of military readiness activities. We have also added additional text clarifying the monitoring requirements of the Armed Forces.

Comment: The procedure for withdrawal of the authority is so cumbersome and subject to so many exclusions as to make the withdrawal procedure non-functional.

Service Response: We have clarified the procedures for when the Secretary may propose withdrawing authorization in § 21.15(b)(2), (4) and (5).

Comment: The statutory language of the Defense Authorization Act says nothing about requiring input from the State Department prior to suspending authorization. Thus, the rule needlessly goes beyond its statutory authority.

Service response: In accordance with the MBTA (16 U.S.C. 704), the Secretary of the Interior has the authority to “determine when, and to what extent, if at all, and by what means, it is compatible with the terms of the conventions to allow hunting, taking, capture, killing * * * and to adopt suitable regulations permitting and governing the same.” The Defense Authorization Act does not limit that authority. Requiring the input of the State Department is within the standards of § 704.

Comment: The provision that the Secretary must seek the view of the Department of Defense prior to suspending authorization due to a violation with any of the treaties it affects permits the Department of Defense to itself determine its compliance with the migratory bird treaties. The statutory language of the Defense Authorization Act did not address this in any way.

Service Response: Section 21.15(b)(1) of this regulation provides that the Secretary retains the discretion to make the ultimate determination that incidental take of migratory birds during a specific military readiness activity would be incompatible with the treaties. Although the Defense Authorization Act required the Secretary to promulgate a regulation, it did not mandate the specific text or all of the conditions in this regulation. This regulation is consistent with the Defense Authorization Act as well as with 16 U.S.C. 704. Moreover, seeking the views of the Armed Forces is appropriate given the possible impacts that suspension of the take authorization could have on national security. Similarly, consulting with the State Department on issues of treaty interpretation is appropriate because of the State Department's expertise and authority in this area as well as its responsibility for maintaining the relationship of the United States with its treaty partners.

Comment: The Secretary should not have unilateral power to suspend or withdraw take authorization as the Defense Authorization Act states the Secretary must exercise authority with the concurrence of the Secretary of Defense.

Service Response: In accordance with § 315(d)(1) and (2) of the Authorization Act, the regulation “to exempt the Armed Forces for the incidental take of migratory birds during military readiness activities” shall be developed by the Secretary of the Interior with the concurrence of the Secretary of Defense. However, the Defense Authorization Act does not restrict or limit our authority in 16 U.S.C. 704 and 712 relative to administering and enforcing the MBTA and complying with the four migratory bird treaties.

Comment: Incidental take is not defined in the rule or the Defense Authorization Act. Concern was expressed that the Department of Defense being authorized to take migratory birds incidental to military readiness activities without “incidental” being defined will result in the Department of Defense reading this as the ability to actively kill migratory birds and destroy their habitat in anticipation of the potential for such problems.

Service Response: Current regulations authorize permits for take of migratory birds for activities such as scientific research, education, and depredation control (50 CFR parts 13, 21 and 22). However, these regulations do not expressly address the issuance of permits for incidental take. “Incidental take of migratory birds” is not defined under the MBTA or in any subsequent regulation, and the Service does not anticipate having a regulatory definition for “incidental take” in the short term. Neither the MBTA, the Defense Authorization Act, nor this rule authorize the take of migratory birds simply in anticipation of the potential for future problems, i.e., removing the potential source of problems before any conflicts may arise with military readiness activities.

Comment: Blanket exemption for any and all military readiness activities should not be authorized. In particular, those activities that involve acquisition of new land and construction of facilities in sensitive migratory bird habitat areas should not be authorized. Authorization to take birds should only include those types of activities that are too time or mission-sensitive for thorough evaluation, and where incidental take is unavoidable.

Service Response: As defined in the 2003 Defense Authorization Act, military readiness activities include all training and operations of the Armed Forces that relate to combat, and the adequate and realistic testing of military equipment, vehicles, weapons, and sensors for proper operation and suitability for combat use. Military readiness does not include (a) routine operation of installation operating support functions, such as: administrative offices; military exchanges; commissaries; water treatment facilities; storage facilities; schools; housing; motor pools; laundries; morale, welfare, and recreation activities; shops; and mess halls, (b) operation of industrial activities, or (c) construction or demolition of facilities listed above.

Acquisition of lands by the Armed Forces is not covered by this authorization as the acquisition itself does not take birds even when the land is being acquired for implementing future military readiness activities. In accordance with NEPA, environmental analysis of any major Federal agency action, which may include land acquisition and future proposed activities on these lands, must be addressed prior to the action occurring. Likewise, construction of facilities in sensitive migratory bird habitat would be addressed through NEPA.

Comment: The rule covers all military branches of service and includes contractors and agents. These should be clearly delineated in order to minimize the number of exempt entities.

Service Response: The rule applies to contractors only when such contractors are performing a military readiness activity in association with the Armed Forces—i.e., the contractors are performing a federal function. For example, a contractor training troops on the operation of a new weapons system or testing its interoperability with existing weapons systems would be covered. The regulation does not cover routine contractor testing performed at an industrial activity that is privately owned and operated.

Comment: The Defense Authorization Act does not limit applicability of minimization and mitigation measures to just “species of concern” but applies to all “affected species of migratory birds.” In addition, concern was expressed that this level of threshold could result in avoidable impacts to species that are not included in the “species of concern lists” but are nevertheless valuable public resources.

Service Response: We agree that the Defense Authorization Act is not specifically limited to species of concern, nor did we envision that the rule prevents the Armed Forces from addressing adverse impacts on all affected species of migratory birds through the NEPA process, including those that are locally endemic or otherwise have limited distribution within a State. The rule has been modified by requiring the Armed Forces to confer with the Service when they determine an action may result in a significant adverse effect on the population of any migratory bird species.

Comment: Use of population status at the Bird Conservation Region (BCR) level as a criterion for action could reduce consideration of locally important bird resources, concentrations of birds and special habitats, and populations that do not coincide closely with BCRs.

Service Response: We have revised the definition of population so that it is not based upon species distribution or occurrence within a Bird Conservation Region and thus eliminates the concerns expressed above. As used in the rule, a population is defined as “a group of distinct, coexisting (conspecific) individuals of a single species, whose breeding site fidelity, migration routes, and wintering areas are temporally and spatially stable, sufficiently distinct geographically (at some time of the year), and adequately described so that the population can be effectively monitored to discern changes in its status.”

What constitutes a population for the purposes of determining potential effects of military readiness activities will be scientifically based. A population could be defined as one that occurs spatially across a geographically broad area, such as the Western Atlantic red knot population that migrates along the Atlantic seaboard, to a more geographically limited species, such as breeding population of Bicknell's thrush whose breeding range is limited to mountain tops in the northeastern U.S. and southeastern Canada. When requested, the Service will provide technical assistance to the Armed Forces in identifying specific populations of migratory bird species that may be affected by a military readiness activity.

Comment: The definition of conservation measure does not adequately recognize international treaty obligations and the right of the Secretary of the Interior to withdraw take authorization should the treaties be violated. In the definitions, after the words “while allowing for completion of the action in a timely manner,” insert “if such action would be consistent with the international treaties underlying the MBTA.”

Service Response: If conservation measures implemented by the Armed Forces in accordance with the rule are not sufficient to render the action compliant with the treaties, the Secretary will suspend the authorization. Failure to implement conservation measures is not the sole criterion for proposing withdrawal.

Comment: “Conservation measures” is defined to include monitoring when it has the potential to produce data relevant to substantiating impacts, validating effectiveness of mitigation, or providing other pertinent information. However, in the absence of a monitoring requirement, this provision is unworkable.

Service Response: Monitoring is required in § 21.15(b)(ii) of the rule. This section indicates that the Department of Defense's failure “to conduct mutually agreed upon monitoring to determine the effects of military readiness activity on migratory bird species and/or the efficacy of the conservation measures implemented by the Department of Defense” is potential cause for the Secretary to propose withdrawing authorization. However, as indicated in the response below, reference to monitoring has been removed from the definition of conservation measures.

Comment: Monitoring should not be considered a conservation measure, rather it should be conducted separately and apart from any necessary and reasonable mitigation actions.

Service Response: Although monitoring can play a key role in the continued growth of bird conservation by providing the information needed to inform conservation decisions and evaluate their effectiveness, we have removed it from the definition of conservation measures.

Comment: The threshold of “significant adverse effect on the sustainability of a population” is too high.

Service Response: The threshold for when the Armed Forces will be required to confer with the Service and implement appropriate conservation measures has been modified to when a “significant adverse effect on a population of migratory bird species” may result from an ongoing or proposed military readiness activity. The definition of significant adverse effect has also been accordingly revised in the rule.

Comment: The rule has a different standard than what was indicated by Congress in the Defense Authorization Act. The Act indicates measures are to be identified that minimize and mitigate “any adverse impacts” not just “significant adverse effects.” The Service is inserting thresholds of both likelihood and significance that are not any way implied by the statute.

Service Response: As indicated in Section 315(b) of the Authorization Act, the identification of measures to minimize and mitigate any adverse impacts of authorized military readiness activities pertains to the period of interim authority. The standard for authorization of take is established by the Secretary's authority under § 704 of the MBTA, whereby in exercising this authority he/she may prescribe regulations that exempt the Armed Forces for the incidental taking of migratory birds during military readiness activities. As indicated in the rule, the Secretary established thresholds for granting authority to incidentally take migratory birds. For those military readiness activities that would not have a significant adverse effect on migratory bird species populations take is authorized without conferring with the Service, subject to the withdrawal provision of § 21.15(b)(1). If a proposed or ongoing activity may result in a significant adverse effect, the Armed Forces must confer and cooperate with the Service. Take authorization would be suspended or withdrawn only when a military readiness activity likely would not be compatible with one or more of the treaties or is likely to result in a significant adverse effect on a migratory bird population.

Comment: Conservation measures that are project designs or mitigation activities should be changed from those that are “reasonable and feasible” to “reasonable and necessary.” This will result in a conservation measure that is appropriate to its purpose and essential to conservation.

Service Response: This revision has been made to the definition of conservation measures.

Comment: “Conservation measures” fails to place any restrictions or requirements on the amount of time that the Department of Defense would be given to apply the mitigation actions. The phrase “over time” implicitly grants the Department of Defense the ability to ignore the need for immediate action to counter adverse impacts.

Service Response: “Over time” was deleted from the definition.

Many comments were received on the Supplementary section of the proposed rule which did not pertain to any recommended revisions to § 21.15. These were taken into consideration in the final rule.

Comment: Ambiguous terms such as “should,” “encourage,” “anticipates,” etc., relative to Department of Defense activities contributing towards the conservation of migratory birds should be replaced with stronger terms such as “require.”

Service Response: The SUPPLEMENTARY INFORMATION text has no regulatory force and thus use of stronger terms has no regulatory weight. However, this comment was given due consideration and several revisions were made to strengthen the measures the Armed Forces are currently undertaking to address migratory bird conservation. These terms are not applicable in the actual rule, and therefore, no revisions were made relative to the authorization in this regard.

Comment: Integrated Natural Resources Management Plans (INRMPs) as informal mechanisms may not provide prompt and diligent efforts to minimize permitted take of birds. State wildlife agencies encourage more rigorous and thorough planning requirements and offer their considerable expertise and assistance.

Service Response: The Sikes Act Improvement Act of 1997 (included in Pub. L. 105-85) requires the development and implementation of INRMPs for relevant Department of Defense installations and mandates that plans be prepared in cooperation with the Service and State fish and wildlife agencies. The purpose of INRMPs is to plan natural resource management activities within the capabilities of the biological setting to support military training requirements. Although the Sikes Act does not apply to the Coast Guard, the Coast Guard is also starting to encourage their bases to address natural resource activities through INRMPs. The Service has been and continues to be committed to expanding partnerships with the Department of Defense. Updated Department of Defense guidance stresses that installations shall work in cooperation with the Service and States while developing or revising INRMPs. Each installation will invite annual feedback from the Service and States concerning how effectively the INRMP is being implemented. Installations have also established and maintain regular communications with the Service and State fish and wildlife agencies to address issues concerning natural resources management including migratory birds.

The Sikes Act also offers opportunities beyond the INRMP process for States and the Service to offer their expertise and assistance on military lands and with respect to migratory birds. For example, under the Sikes Act, the Department of Defense can enter into cooperative agreements with the Service, States, and nonprofit organizations to benefit birds and other species. Programs such as the Chesapeake Bay Program, Coastal America, and Partners In Flight also offer opportunities to partner with States and to share information and advice.

Comment: If the Service must rely on INRMPs for monitoring and mitigation of bird take, we recommend a requirement to complete, revise, and update plans to address bird monitoring and assessment of military readiness impacts and that migratory bird conservation activities receive adequate funding.

Service Response: The Sikes Act and Department of Defense guidance provide mechanisms to address emerging needs related to bird monitoring and assessment of military readiness impacts. The Sikes Act requires INRMPs to be reviewed, and revised as necessary, as to operation and effect by the parties (i.e., the Service and State resource agencies) on a regular basis, but not less often than every 5 years. In October 2004, the Department of Defense issued supplemental guidance for implementation of the Sikes Act relating to INRMP reviews. Department of Defense policy requires installations to review INRMPs annually in cooperation with the Service and State resource agencies. Annual reviews facilitate adaptive management by providing an opportunity for the parties to review the goals and objectives of the plans and to establish a realistic schedule for undertaking proposed actions. During annual reviews of the INRMPs, the Department of Defense will also discuss with the Service conservation measures implemented and the effectiveness of these measures in avoiding, minimizing, or mitigating take of migratory birds.

This rule relies on the Armed Forces utilizing the NEPA process to determine whether any ongoing or proposed military readiness activity is likely to result in a significant adverse effect on a population of a migratory bird species. The rule requires the Armed Forces to develop and implement appropriate conservation measures if a proposed action may have a significant adverse effect on a population of migratory bird species. To ensure that such conservation measures adequately address impacts to migratory birds, the rule also requires the Armed Forces to monitor the effects of such military readiness activities on migratory bird species taken during the military readiness activities at issue, and to retain records of these measures and monitoring data for 5 years from the date the Armed Forces commence their action.

Comment: We do not believe that impacts addressed by this rule can be adequately monitored or remedied without commitment of more resources to gather new bird data, conduct additional efforts to monitor impacts, or spend more money.

Service Response: Although the rule requires the Armed Forces to conduct mutually agreed upon monitoring to determine the effects of a military readiness activity on migratory bird species and the efficacy of the conservation measures implemented by the Armed Forces, we cannot require the Armed Forces to provide additional funding or resources towards monitoring. However, we do agree that monitoring is an important component of activities the Armed Forces undertake to address migratory bird conservation. We have expanded the monitoring discussion under “Rule Authorization” below.

Comment: Concern was expressed that the proposed broad exemption will be perceived as precluding the need for full NEPA consideration for covered activities.

Service Response: As stated in this rule, the Armed Forces will continue to be responsible for being in compliance with NEPA, and all other applicable regulations, and ensuring that whenever they propose to undertake new military readiness activities or to adopt a new, or materially revised, INRMP and migratory bird species may be affected, the Armed Forces invite the Service to comment as an agency with “jurisdiction by law or special expertise” upon their NEPA analysis. In addition, if the potential for significant effects on migratory birds makes it appropriate, the Armed Forces may invite the Service to participate as a cooperating agency in the preparation of their NEPA analysis. Moreover, authorization under this rule requires that if a proposed military readiness activity may result in a significant adverse impact on a population of migratory bird species, the Armed Forces must confer and cooperate with the Service to develop and implement appropriate measures to minimize or mitigate these effects. The environmental consequences of the proposed military readiness activity, as well as the potential of any such measures to reduce the adverse effects of the proposed activity, would be covered in NEPA documentation prepared for the proposed action.

Comment: The Department of Defense should be required to demonstrate that all “practicable” means of avoiding the “take” of migratory birds have been considered prior to the implementation of a new readiness program or construction of a new installation.

Service Response: The Armed Forces will be addressing “take” in a variety of ways. As stated above, through the NEPA process, the environmental consequences of their proposed military readiness activities will be evaluated, as well as any measures to reduce take of migratory birds. In addition, the INRMPs currently incorporate conservation measures to address migratory bird conservation. The Service will continue to work with the Armed Forces to develop additional measures in the future.

Comment: Nowhere does the rule mention how and when the Department of Defense will assess current, ongoing activities for which NEPA compliance is complete. The rule should be amended to require, within a specified time period of 90-120 days, a report by the Department of Defense to the Secretary on the impacts of their current military readiness activities on migratory birds.

Service Response: As a preliminary matter, it is important to note that where NEPA compliance has been completed, that compliance should have included consideration of the impacts on migratory birds. Since the enactment of NEPA, the Service has been notified of, and provided the opportunity to comment on, proposed military readiness activities that have the potential for significant impacts on the environment, including significant impacts on migratory birds. Nevertheless, it is possible that ongoing military readiness activities might in the future be determined to meet the threshold for the requirement under § 21.15(a)(1) to “confer and cooperate.” There are at least three mechanisms in place that require the Armed Forces to address environment impacts of ongoing activities for which NEPA is complete; supplementary statements under NEPA, INRMP reviews, and the monitoring requirements in the rule.

In accordance with NEPA Part 1502.9, an agency shall prepare a supplement to either a draft or a final environmental impact statement whenever: (1) The agency makes substantial changes in the proposed action that are relevant to environmental concerns; or (2) the agency learns of significant new circumstances or information relevant to environmental concerns and bearing on the proposed action or its impacts. This rule relies on the Armed Forces to use the NEPA process to determine whether an ongoing military readiness activity may result in a significant adverse effect on a population of a migratory bird species.

The Sikes Act (16 U.S.C. 670a-670o), enacted in 1960, has required cooperation among the Department of Defense, the Service, and State wildlife agencies. The 1997 amendments to the Sikes Act require the development of INRMPs that reflect the mutual agreement of the Department of Defense, the Service, and the appropriate State wildlife agency. The Sikes Act provides the Service, as well as the public, an opportunity to review natural resources management on military lands, including any potential effects on migratory birds or their habitat. NEPA documentation is prepared to support new or revised INRMPs. Department of Defense policy requires installations to review INRMPs annually in cooperation with the Service and State resource agencies. Annual reviews facilitate adaptive management by providing an opportunity for the parties to review the goals and objectives of the plans and to evaluate any new scientific information that indicates the potential for adverse impacts on migratory birds from new or ongoing military readiness activities. In addition, during annual INRMP reviews, the Department of Defense, the Service and the State resources agency evaluate the conservation measures implemented and the effectiveness of these measures in avoiding, minimizing, or mitigating take of migratory birds.

This rule requires the Armed Forces to develop and implement appropriate conservation measures if a proposed action may have a significant adverse effect on a population of migratory bird species. When conservation measures implemented in accordance with § 21.15(a)(1) require monitoring, the Armed Forces must retain records of these measures and monitoring data for 5 years from the date the Armed Forces commence their action.

Comment: We disagree with the interpretation of the statute that Congress “signaled that the Department of Defense should give appropriate consideration to the protection of migratory birds when planning and executing military readiness activities, but not at the expense of diminishing the effectiveness of such activities.” This suggests a diminishment of protection for migratory birds. It was Congress's intent that the Department of Defense should not be forced to halt these activities but rather should modify them to minimize impacts, or, if such activities cannot be practicably altered to minimize impacts, that mitigation measures must be in place to ensure conservation of migratory birds.

Service Response: This rule will not diminish the protection of migratory birds. Rather, by requiring the Armed Forces to confer with the Service to develop and implement conservation measures when a military readiness activity may significantly affect a population of a migratory bird species, a greater benefit to birds will result than the current status operandi. Increased coordination and technical assistance between the Service and the Armed Forces will reduce the number of migratory birds that are incidentally taken as a result of military readiness activities.

As the basis for this rule, under the authority of the MBTA and in accordance with Section 315 of the Authorization Act, the Armed Forces will consult with the Service to identify measures to minimize and mitigate adverse impacts of authorized military readiness activities on migratory birds and to identify techniques and protocols to monitor impacts of such activities. The inventory, avoidance, habitat enhancement, partnerships, and monitoring efforts described below illustrate the efforts currently undertaken by the Armed Forces to minimize or mitigate adverse impacts to migratory birds from testing and training activities to maintain a ready defense. Additional conservation measures, designed to minimize and mitigate adverse impacts of authorized military readiness activities on affected migratory bird species, with emphasis on species of concern, will be developed in joint coordination with the Service when evaluation of specific military readiness activities indicates the need for additional measures.

We have a long history of working with natural resources managers at Armed Forces installations through our Field Offices to develop and implement these conservation initiatives. Many of the conservation measures detailed below represent state-of-the-art techniques and practices to inventory, protect, and monitor migratory bird populations. In accordance with provisions of the Sikes Act, as amended, these conservation measures are detailed in Department of Defense INRMPs for specific installations and endorsed by the Service and State fish and wildlife agencies. Additional conservation measures may be incorporated into future revisions of the INRMPs if determined necessary during their quintennial review.

Bird Conservation Planning. The Department of Defense prepares INRMPs for most Department of Defense installations. Under the Sikes Act, the Department of Defense must provide for the conservation and rehabilitation of natural resources on military installations. To facilitate the program, the Secretary of Defense prepares and implements an INRMP for each military installation in the United States on which significant natural resources are found. The resulting plans must reflect the mutual agreement of the military installation, the Service, and the appropriate State fish and wildlife agency on conservation, protection, and management of fish and wildlife resources. The importance of a cooperative relationship among these parties is also stressed in Department of Defense and Service guidances concerning INRMP development and review. In accordance with the Department of Defense guidance, each installation will invite annual feedback from the Service and States concerning how effectively the INRMP is being implemented. Installations also maintain regular communications with the Service and State fish and wildlife agencies to address issues concerning natural resources management including migratory birds. Although the Sikes Act does not apply to the Coast Guard, they are also starting to encourage applicable bases to develop INRMPs.

INRMPs incorporate conservation measures addressed in Regional or State Bird Conservation Plans to ensure that the Department of Defense does its part in landscape-level management efforts. INRMPs are a significant source of baseline conservation information and conservation initiatives used to develop NEPA documents for military readiness activities. This linkage helps to ensure that appropriate conservation measures are incorporated into mitigation actions, where needed, that will protect migratory birds and their habitats.

To-date, over 370 INRMPs have been approved. Through cooperative planning in the development, review and revision of INRMPs, the Department of Defense, the Service and the States can effectively avoid or minimize adverse impacts on migratory bird populations. Through this process, the Service and the Department of Defense will continue to work together to design and develop monitoring surveys that effectively evaluate population trends and cumulative impacts on installations.

The Fish and Wildlife Conservation Act of 1980, as amended in 1988, directs the Secretary of the Interior to “identify species, subspecies, and populations of all migratory non-game birds that, without additional conservation action, are likely to become candidates for listing under the Endangered Species Act of 1973.” This list is prepared and updated at 5-year intervals by the Service's Division of Migratory Bird Management. The current list of the “Birds of Conservation Concern” is available at http://migratorybirds.fws.gov/reports/bcc2002.pdf .

“Birds of Conservation Concern 2002” includes species that are of concern because of (a) documented or apparent population declines, (b) small or restricted populations, or (c) dependence on restricted or vulnerable habitats. It includes three distinct geographic scales: Bird Conservation Regions, Service Regions, and National. The Service Regions include the seven Service Regions plus the Hawaiian Islands and Puerto Rico/U.S. Virgin Islands.

Bird Conservation Regions (BCRs), adopted by the North American Bird Conservation Initiative (NABCI), are the most basic geographical unit by which migratory birds are designated as birds of conservation concern. The BCR list includes certain species endemic to Hawaii, the Pacific Island territories, and the U.S. Caribbean Islands that are not protected by the MBTA, and thus are not subject to this rule. These species are clearly identified in the list. The complete BCR list contains 276 species. NABCI is a coalition of U.S., Canadian, and Mexican governmental agencies and private organizations working together to establish an inclusive framework to facilitate regionally based, biologically driven, landscape-oriented bird conservation partnerships. A map of the NABCI BCRs can be viewed at http://www.nabci-us.org .

The comprehensive bird conservation plans, such as the North American Waterfowl Management Plan, the U.S. Shorebird Conservation Plan, Partners in Flight (PIF) Bird Conservation Plans, and the North American Waterbird Conservation Plan, are the result of coordinated partnership-based national and international initiatives dedicated to migratory bird conservation. Each of these initiatives has produced landscape-oriented conservation plans that lay out population goals and habitat objectives for birds. Additional information on these plans and their respective migratory bird conservation goals can be found at:

North American Waterfowl Management Plan ( http://birdhabitat.fws.gov/NAWMP/nawmphp.htm ).

North American Waterbird Conservation Plan ( http://www.waterbirdconservation.org ).

U.S. Shorebird Conservation Plan ( http://shorebirdplan.fws.gov/ ).

Partners in Flight ( http://www.partnersinflight.org ).

Conservation Partnerships. The Department of Defense has entered into a number of conservation partnerships with nonmilitary partners to improve habitats and protect avian species. In 1991, the Department of Defense, through each of the military services, joined the PIF initiative. The Department of Defense developed a PIF Strategic Plan in 1994, and revised it in 2002. The Department of Defense PIF program is recognized as a model conservation partnership program. Through the PIF initiative, the Department of Defense works in partnership with over 300 Federal and State agencies and nongovernmental organizations (NGOs) for the conservation of neotropical migratory and resident birds and enhancement of migratory bird survival. For example, bases have worked with NGOs to develop management plans that address such issues as grazing and the conversion of wastewater treatment ponds to wetlands and suitable habitat. Universities use Department of Defense lands for migratory bird research and, on occasion, re-establish nesting pairs to take advantage of an installation's hospitable habitat. The Department of Defense PIF program tracks this research and provides links between complementary research on different installations and service branches.

The Authorization Act included a provision that allows the Department of Defense to provide property at closed bases to conservation organizations for use as habitat and another provision that, in order to lessen problems of encroachment, allows the Department of Defense to purchase conservation easements on suitable property in partnership with other groups. Where utilized, these provisions will offer further conservation benefits to migratory birds.

Bird Inventories. The most important factor in minimizing and mitigating takes of migratory birds is an understanding of when and where such takes are likely to occur. This means developing knowledge of migratory bird habits and life histories, including their migratory paths and stopovers as well as their feeding, breeding, and nesting habits.

The Department of Defense implements bird inventories and monitoring programs in numerous ways. Some Department of Defense installations have developed partnerships with the Institute for Bird Populations to Establish Monitoring Avian Productivity and Survivorship (MAPS) stations. The major objective of the MAPS program is to contribute to an integrated avian population monitoring system for North American land birds by providing annual regional indices and estimates for four populations and demographic parameters for select target species in seven different regions of North America. The MAPS methodology provides annual regional indices of adult population size and post-fledgling productivity from data on the numbers and proportions of young and adult birds captured; annual regional estimates of adult population size, adult survivorship, and recruitment into the adult population from capture-recapture data on adult birds; and additional annual estimates of adult population size from point-count data collected in the vicinity of MAPS stations. Without these critical data, it is difficult or impossible to account for observed population changes. The Department of Defense is helping to establish a network of MAPS stations in all seven biogeographical regions and build the program necessary to monitor neotropical migratory bird population changes nationwide. Approximately 20% of the continental MAPS network involves military lands.

Since the early 1940s, radar has been used to monitor bird migration. The newest weather surveillance radar, WSR-88D or NEXRAD (for Next Generation Radar), is ideal for studies of bird movements in the atmosphere. This sophisticated radar system can be used to map geographical areas of high bird activity (e.g., stopover, roosting and feeding, and colonial breeding areas). It also provides information on the quantity, general direction, and altitudinal distribution of birds aloft. Currently, the United States Air Force is using NEXRAD, via the U.S. Avian Hazard Advisory System (AHAS), to provide bird hazard advisories to all pilots, military and civilian, in an attempt to warn air traffic of significant bird activity. The information is publicly available for the contiguous United States on line at http://www.usahas.com and will soon be available for the State of Alaska.

NEXRAD information is critically important for the protection of habitats used by migratory birds during stopover periods. This information is vital to Department of Defense land managers who protect stopover areas on military land. The data is also particularly important to land managers of military air stations where bird/aircraft collisions threaten lives and cost millions of dollars in damages every year. The Department of Defense established a partnership with the Department of Biological Sciences at Clemson University to collect, analyze, and use the biological information from the NEXRAD network to identify important stopover habitat in relation to Department of Defense installations. Initial efforts were concentrated in the Southeast to complement existing radar data from the Gulf Coast. This partnership has enabled the collection and transfer of radar data from all NEXRAD sites, via modem, to one remote station at Clemson University, where the data can be archived and analyzed.

The Department of Defense uses bird inventory and survey information in connection with the preparation of INRMPs. The Department of Defense also uses bird inventory and survey information when undertaking environmental analyses required under the NEPA. An environmental assessment or an environmental impact statement is used to determine the potential effects of any new, planned activity on natural resources, including migratory birds.

The Department of Defense PIF program is currently developing a database of migratory bird species of concern that are likely to occur on each installation utilizing the Service's published list of Birds of Conservation Concern ( http://migratorybirds.fws.gov/reports/bcc2002.pdf ); priority migratory bird species documented in the comprehensive bird conservation plans (North American Waterbird Conservation Plan ( http://www.waterbirdconservation.org ), United States Shorebird Conservation Plan ( http://shorebirdplan.fws.gov ), Partners in Flight Bird Conservation Plans ( http://www.partnersinflight.org/ ); species or populations of waterfowl identified as high, or moderately high, continental priority in the North American Waterfowl Management Plan; listed threatened and endangered bird species in 50 CFR 17.11; and Migratory Bird Treaty Act-listed game birds below desired population sizes ( http://migratorybirds.fws.gov/reports/reports.html ).

Avoidance. Avoidance is the most effective means of minimizing takes of migratory birds. Where practicable, the Department of Defense avoids potentially harmful use of nesting sites during breeding and nesting seasons and of resting sites on migratory pathways during migration seasons. Avoidance sometimes involves using one area of a range rather than another. On some sites in which bombing, strafing, or other activities involving the use of live military munitions could affect birds in the area, the Department of Defense may conduct an initial, benign sweep of the site to ensure that any migratory birds in the area are dispersed before live ordnance is used. Another tool used by the Department of Defense to deconflict flight training activities is the U.S. Air Force Bird Avoidance Model (BAM). This model places breeding bird and Christmas count data into a Geographic Information Systems model to assist range planners in selecting training times when bird activity is low. The BAM is available online at the http://www.usahas.com Web site.

Pesticide Reduction. Reducing or eliminating pesticide use also benefits migratory birds. The Armed Forces maintain an integrated pest management (IPM) program that is designed to reduce the use of pesticides to the minimum necessary. The Department of Defense policy requires all operations, activities, and installations worldwide to establish and maintain safe, effective, and environmentally sound IPM programs. IPM is defined as a planned program, incorporating continuous monitoring, education, record-keeping, and communication to prevent pests and disease vectors from causing unacceptable damage to operations, people, property, material, or the environment. IPM uses targeted, sustainable (i.e., effective, economical, and environmentally sound) methods, including education, habitat modification, biological control, genetic control, cultural control, mechanical control, physical control, regulatory control, and the judicious use of least-hazardous pesticides. Department of Defense policy mandates incorporation of sustainable IPM philosophy, strategies, and techniques in all aspects of Department of Defense pest management planning, training, and operations, including installation pest-management plans and other written guidance to reduce pesticide risk and prevent pollution.

Habitat Conservation and Enhancement. Habitat conservation and enhancement generally involve improvements to existing habitat, the creation of new habitat for migratory birds, and enhancing degraded habitats. Improvements to existing habitat include wetland protection, maintenance and enhancement of forest buffers, elimination of feral animals (in particularly feral cats) that may be a threat to migratory birds, and elimination of invasive species that crowd out other species necessary to migratory bird survival. Examples of the latter include control and elimination of brown tree snake, Japanese honeysuckle, kudzu, and brown-headed cowbirds.

Efforts to eliminate invasive species are being undertaken in association with natural resources management under Sikes Act INRMPs. For example, at one site, grazing was reduced from more than 60,000 to about 23,000 acres, and has become a management tool to enhance the competitive advantage of native plants, especially perennial grasses. Special projects are under way on Department of Defense property to control exotic plants and to remove unused structures that occupy potentially valuable habitat or unnaturally increase predator populations. At some locations, native forest habitat is being reestablished.

The preparation of INRMPs continues to offer opportunities to consider such land management measures as converting to uneven-age and/or other progressive forest management that enhances available habitat values, establishing native warm-season grasslands, maintaining and enhancing bottomland hardwood forests, and promoting positive water-use modifications to improve hydrology and avian habitat in arid areas. Department of Defense installations are active in promoting the use of nest boxes and, where appropriate, the use of communications towers for nesting. In addition, the Department of Defense PIF program has prepared fact sheets addressing such issues as communications towers and power lines, West Nile virus, wind energy development, the Important Bird Areas program, and bird/aircraft strike hazards (BASH).

Other. At a few sites where the potential for migratory bird take is more severe, the Department of Defense has implemented extensive mitigation measures. In such instances, the responsible military service has taken practicable measures to minimize the impacts of its operations on protected migratory birds. Such measures include limiting the type and quantity of ordnance; limiting target areas and activities to places and times that protect key nesting areas for migratory birds; implementing fire-suppression programs or measures where wildfire can potentially damage nesting habitat; conducting environmental monitoring; and implementing mitigation measures, such as predator removal, on the site or nearby.

The Authorization Act requires the Armed Forces to identify measures to monitor the impacts of military readiness activities on migratory birds. For military lands where migratory bird data may be lacking, monitoring may include the collection of baseline demographic, population, or habitat-association data. Where feasible, the Armed Forces will conduct agreed-upon monitoring to determine the level of take from military readiness activities.

Monitoring provides important data regarding the impacts of military readiness on migratory birds. It also contributes valuable information where data on species of migratory birds may be limited. In addition, monitoring data assists the Armed Forces in guiding their decisions regarding migratory bird conservation, particularly in developing or amending INRMPs.

The Department of Defense monitors bird populations that may be affected by military readiness activities in numerous ways. In addition to the MAPS program discussed above, Department of Defense facilities participate in the Breeding Biology Research and Monitoring Database (BBIRD) program to study nesting success and habitat requirements for breeding birds. Many installations also engage in Christmas bird counts, migration counts (Point, Circle, Area, or Flyover Counts), standardized and/or customized breeding and wintering point counts, grassland-bird flush counts, NEXRAD (discussed above) and BIRDRAD studies, point count surveys, hawk watches, overflight surveys, and/or rookery surveys. At sites where bird takes are a concern, such as Farallon de Medinilla in the Northern Marianas, the Department of Defense engages in more extensive monitoring, including overflight and rookery surveys several times a year, so that it can monitor trends in bird populations.

The Department of Defense is not alone in monitoring the status of birds on its installations. Much of its monitoring is done through formal partnerships with conservation organizations. In addition, Watchable Wildlife programs provide opportunities for the public to provide feedback on the numbers and types of birds they have observed from viewing sites on Department of Defense installations.

The Armed Forces can use clear evidence of bird takes, such as the sight of numerous dead or injured birds, as a signal that it should modify its activities, as practicable, to reduce the number of takes. With respect to the problem of bird/aircraft collisions, the Department of Defense undertakes intensive, bird-by-bird monitoring. The U.S. Air Force Safety Center's Bird/Wildlife Aircraft Strike Hazard team at Kirtland Air Force Base, NM, and the Navy Safety Center at Norfolk, VA, track aircraft/wildlife (bird and mammal) collisions because of the danger such collisions represent to pilots, crews, and aircraft. By focusing on local, regional, and seasonal populations and movements of birds, pilots and airport personnel have been better able to avoid collisions, in many cases by modifying those conditions at airfields that are attractive to birds.

NEPA, and the Council on Environmental Quality's (CEQ) NEPA implementing regulations at 40 CFR 1500-1508, require that Federal agencies prepare environmental impact statements for “major Federal actions significantly affecting the quality of the human environment.” These statements must include a detailed analysis of the impacts of an agency's proposed action and any reasonable alternatives to that proposal. NEPA requires the responsible Federal official to “consult with and obtain comments of any Federal agency which has jurisdiction by law or special expertise with respect to any environmental impact involved” (42 U.S.C. 4332(2)(C)). NEPA also provides for public involvement in the decision-making process. The CEQ's regulations implementing NEPA emphasize the integration of the NEPA process with the requirements of other environmental laws. The CEQ regulations at 40 CFR 1500.2 state: “Federal agencies shall to the fullest extent possible * * * integrate the requirements of NEPA with other planning and environmental review procedures required by law or by agency practice so that all such procedures run concurrently rather than consecutively.” Regulations at 40 CFR 1502.25 state: “To the fullest extent possible, agencies shall prepare draft environmental impact statements concurrently with and integrated with environmental impact analyses and related surveys and studies required by * * * other environmental review laws and executive orders.”

In keeping with this emphasis, the rule relies on the Armed Forces utilizing the NEPA process to determine whether any ongoing or proposed military readiness activity is “likely to result in a significant adverse effect on the population of a migratory bird species.” More particularly, the Armed Forces prepare NEPA analyses whenever they propose to undertake a new military readiness activity that may significantly affect the quality of the human environment; propose to make a substantial change to an ongoing military readiness activity that is relevant to environmental concerns; learn of significant new circumstances or information relevant to the environmental concerns bearing on an ongoing military readiness activity; or prepare or revise an INRMP covering an area used for military readiness activities. During the preparation of environmental impact statements analyzing the effects of proposed military readiness activities on migratory bird species, the Armed Forces consult with the Service as an agency with “jurisdiction by law and special expertise.” If the Armed Forces identify a significant adverse effect on migratory birds during the preparation of a NEPA analysis, this rule requires the Armed Forces to confer and cooperate with the Service to develop and implement appropriate conservation measures to minimize or mitigate any such significant adverse effects. The Armed Forces will continue to be responsible for ensuring that military readiness activities are implemented in accordance with all applicable statutes including NEPA and ESA.

Section 7(a)(1) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq. ) (ESA), provides that, “[t]he Secretary [of the Interior] shall review other programs administered by him and utilize such programs in furtherance of the purposes of this Act.” Furthermore, section 7(a)(2) requires all Federal agencies to insure that any action authorized, funded, or carried out is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of critical habitat. We completed an Intra-Service Consultation on the proposed rule and we have determined that this rule to authorize take under the MBTA will have no effect on listed species. The rule does not authorize take under the ESA. If a military readiness activity may affect a listed species, the Armed Forces retains responsibility for consulting with the Service under section 7(a)(2) of the ESA. Similarly, if a military readiness activity is likely to jeopardize the continued existence of a species proposed for listing, the Armed Forces retain responsibility for conferring with the Service in accordance with section 7(a)(4) of the ESA.

This rule authorizes the Armed Forces to take migratory birds as an incidental result of military readiness activities. The Armed Forces must continue to apply for and receive an MBTA permit for scientific collecting, control of birds causing damage to military property, or any other activity that is addressed by our existing permit regulations (50 CFR part 13, 21, 22). These activities may not be conducted under the authority of this rule. If any activity of the Armed Forces falls within the scope of our existing regulations, we will consider, when processing the application, the specific take requested as well as any other take authorized by this rule that may occur.

Authorization of take under this rule applies to take of migratory birds incidental to military readiness activities, including (a) all training and operations of the Armed Forces that relate to combat, and (b) the adequate and realistic testing of military equipment, vehicles, weapons, and sensors for proper operation and suitability for combat use. Authorization of take does not apply to (a) routine operation of installation operating support functions, such as: administrative offices; military exchanges; commissaries; water treatment facilities; storage facilities; schools; housing; motor pools; laundries; morale, welfare, and recreation activities; shops; and mess halls, (b) operation of industrial activities, or (c) construction or demolition of facilities listed above.

The authorization provided by this rule is subject to the military service conducting an otherwise lawful military readiness activity in compliance with the provisions of the rule. To ensure the Service maintains the ability to manage and conserve the resource, the Secretary retains the authority to withdraw or suspend authorization of take with respect to any specific military readiness activity under certain circumstances.

With respect to a military readiness activity of the Armed Forces likely to take migratory birds, the rule authorizes take provided the Armed Forces are in compliance with the following requirement:

The Armed Forces will continue to be responsible for addressing their activities other than military readiness through a MOU developed in accordance with Executive Order 13186, “Responsibilities of Federal Agencies to Protect Migratory Birds,” January 10, 2001.

If a proposed or an ongoing action may have a significant adverse effect on a population of a migratory bird species, as that term is defined in Section 21.3, the Armed Forces must confer with the Service so that we may recommend conservation measures. In certain circumstances, the Secretary must suspend the take authorization with respect to a particular military readiness activity; in other circumstances, the Secretary has the discretion to initiate a process that may result in withdrawal. We will make every effort to work with the Armed Forces in advance of a potential determination to withdraw take authorization in order to resolve migratory bird take concerns and avoid withdrawal. With respect to discretionary withdrawal, the rule provides an elevation process if the Secretary of Defense or other national defense official appointed by the President and confirmed by the Senate determines that protection of national security requires continuation of the activity.

The Secretary will immediately suspend authorization for take if continued authorization likely would not be compatible with any one of the migratory bird treaties. Withdrawal of authorization may be proposed if the Secretary determines that failure to do so is likely to result in a significant adverse effect on a population of a migratory bird species and one or more of the following circumstances apply:

The determination as to whether an immediate suspension of authorization is warranted (i.e., whether the action likely would not be compatible with a migratory bird treaty), or withdrawal of an authorization is proposed will be made independent of each other. Regardless of whether the circumstances of paragraphs (A) through (C) above exist, there will be an immediate suspension if the Secretary determines, after seeking the views of the Secretary of Defense and after consulting with the Secretary of State, that incidental take of migratory birds during a specific military readiness activity likely would not be compatible with one or more of the migratory bird treaties.

Proposed withdrawal of authorization will be provided in writing to the Secretary of Defense including the basis for the determination. The notice will also specify any conservation measures or other measures that would, if the Armed Forces agree to implement them, allow the Secretary to cancel the proposed withdrawal of authorization. Any take incidental to a military readiness activity subject to a proposed withdrawal of authorization will continue to be authorized by this regulation until the Secretary of the Interior, or his/her delegatee, makes a final determination on the withdrawal.

The Secretary may, at his/her discretion, cancel a suspension or withdrawal of authorization at any time. A suspension may be cancelled in the event new information is provided that the proposed activity would be compatible with the migratory bird treaties. A proposed withdrawal may be cancelled if the Armed Forces modify the proposed activity to alleviate significant adverse effects on a population of a migratory bird species or the circumstances in paragraphs (A) through (C) above no longer exist. Cancellation of suspension or withdrawal of authorization becomes effective upon delivery of written notice from the Secretary to the Department of Defense.

In order to ensure that the action of the Secretary in not authorizing take does not result in significant harm to the Nation, any proposal to withdraw authorization under 50 CFR 21.15(b)(2) will be reconsidered by the Secretary or his/her delegatee who must be an official nominated by the President and confirmed by the Senate, if, within 45 days of the notification with respect to a military readiness activity, the Secretary of Defense, or other national defense official, who also must be an official nominated by the President and confirmed by the Senate, determines that protection of the national security requires continuation of the action.

The take authorization provided by the rule applies to military readiness activities of the Armed Forces, including those implemented through contractors of the Armed Forces and their agents.

As discussed above, the only condition applicable to the authorization under this rule is that the Armed Forces confer and cooperate with the Service if the Armed Forces determine that a proposed or an ongoing military readiness activity may result in a significant adverse effect on a population of a migratory bird species. To avoid this threshold from being reached, as well as to provide for migratory bird conservation, it is in the best interest of the Armed Forces to address potential migratory bird impacts from military readiness activities by adopting the following principles and standards.

To proactively address migratory bird conservation, the Armed Forces should engage in early planning and scoping and involve agencies with special expertise in the matters relating to the potential impacts of a proposed action. When a proposed action by the Armed Forces related to military readiness may result in the incidental take of birds, the Armed Forces should contact the Service so we can assist the Armed Forces in addressing potential adverse impacts on birds and mitigating those impacts. As stated in this rule, the Armed Forces must confer with the Service when these actions may have a significant adverse effect on a population of a migratory bird species.

The Armed Forces will, in close coordination with the Service, develop a list of conservation measures designed to minimize and mitigate potential adverse impacts of authorized military readiness activities on affected migratory bird species. A cooperative approach initiated early in the project planning process will have the greatest potential for successfully reducing or eliminating adverse impacts. Our recommendations will emphasize avoidance, minimization, and rectifying adverse impacts. The Armed Forces should consider obvious avoidance measures at the outset of project planning, such as siting projects to avoid important nesting areas or to avoid collisions of birds with structures, or timing projects to avoid peak breeding activity. In addition, models such as the AHAS and BAM should be used to avoid bird activity when planning flight training and range use. The Armed Forces will consider these conservation measures for incorporation in new NEPA analyses, INRMPs, INRMP revisions, and base comprehensive or master plans, whenever adverse impacts to migratory birds may result from proposed military readiness activities.

“Conservation measures” are project designs or mitigation activities that are technically and economically reasonable, and minimize the take of migratory birds and adverse impacts while allowing for completion of an action in a timely manner. When appropriate, the Armed Forces should adopt existing industry guidelines supported by the Service and developed to avoid or minimize take of migratory birds. We recognize that implementation of conservation measures will be subject to the availability of appropriations.

The Armed Forces should promote the inclusion of comprehensive migratory bird management objectives from bird conservation plans into the planning documents of the Armed Forces. The bird conservation plans, available either from the Service's Regional Offices or via the Internet, include: North American Waterfowl Management Plan, PIF, and the U.S. Shorebird Conservation Plan. The North American Waterbird Conservation Plan, the newest planning effort, addresses conservation of seabirds, wading birds, terns, gulls, and some marsh birds, and their habitats. The Armed Forces should also work collaboratively with partners to identify, protect, restore, and manage Important Bird Areas, Western Hemisphere Shorebird Reserve Network sites, and other significant bird sites that occur on Department of Defense lands. The Department of Defense should continue to work through the PIF program to incorporate bird habitat management efforts into INRMPs.

In accordance with the Authorization Act and the 2002 revised Sikes Act guidelines, the annual review of INRMPs by the Department of Defense, in cooperation with the Service and State fish and wildlife agencies, will include monitoring results of any migratory bird conservation measures.

The Armed Forces will use the best available databases to determine which migratory bird species are likely to occur in the area of proposed military readiness activities. This includes species likely to occur in the project area during all phases of the project.

The Armed Forces will use the best scientific data available to assess, through the NEPA process or other environmental requirements, the expected impact of proposed or ongoing military readiness activities on migratory bird species likely to occur in action areas. Special consideration will be given to priority habitats, such as important nesting areas, migration stop-over areas, and wintering habitats.

The Armed Forces will adopt, to the maximum extent practicable, conservation measures designed to minimize and mitigate any adverse impacts of authorized military readiness activities on affected migratory bird species. The term “to the maximum extent practicable” means without limiting the subject readiness activities in ways that compromise the effectiveness of those activities, and to the extent economically feasible.

At the Department of Defense's request, the Service will provide technical assistance in identifying the migratory bird species and determining those likely to be taken as a result of the proposed action, assessing impacts of the action on migratory bird species, and identifying appropriate conservation measures to mitigate adverse impacts.

Yes. This issue has two components. First is the question of whether the MBTA prohibits promulgation of regulations authorizing incidental take of migratory birds pursuant to military readiness activities. Second is the question of whether the details of this rule, individually and collectively, conflict with the MBTA in some way.

The starting point for answering both questions is the fact that Sections 704 and 712(2) of 16 U.S.C. provide us with broad authority to promulgate regulations allowing for the take of migratory birds when compatible with the terms of the migratory bird treaties. We find the take that is authorized in this rule is compatible with the terms of the treaties and consistent with the purposes of the treaties.

Regarding the first question, whether any such regulations are permissible under the MBTA, Congress itself by passing the Authorization Act determined that such regulations are consistent with the MBTA and the underlying treaties by requiring us to promulgate such regulations. Even in the absence of the Authorization Act, regulations authorizing take incidental to military readiness activities are compatible with the terms of the treaties, and therefore authorized by the MBTA.

The MBTA implements four treaties: a 1916 treaty with Great Britain on behalf of Canada that was substantially amended by a 1995 protocol; a 1936 treaty with Mexico, amended by a 1997 protocol; a 1972 treaty with Japan; and a 1978 treaty with the former Soviet Union. These international agreements recognize that migratory birds are important for a variety of purposes. They provide a food resource, insectivorous birds are useful to agriculture, they provide recreational benefits and are useful for scientific and educational purposes, and they are important for aesthetic, social, and spiritual purposes. Collectively, the treaties require the Unites States to provide mechanisms for protecting the birds and their habitats, and include special emphasis on protecting those birds that are in danger of extinction.

The Japan and Russia treaties each call for implementing legislation that broadly prohibits the take of migratory birds. At the same time, those treaties allow the implementing legislation to include exceptions to the take prohibitions. The treaties recognize a variety of purposes for which take may be authorized, including scientific, educational, and propagative purposes; the protection of persons or property; and hunting during open seasons. The treaties also contemplate authorizing takings “for specific purposes not inconsistent with the objectives [or principles]” of the treaties. The Canada treaty, since adoption of the 1995 Protocol, now includes similar language: “the taking of migratory birds may be allowed * * * for * * * specific purposes consistent with the conservation principles of this Convention.”

In contrast, the take prohibitions required by the 1936 Mexico treaty have a narrower focus than the later treaties. The Mexico treaty is more clearly directed at stopping the indiscriminate killing of migratory birds by hunting and for commercial purposes through the establishment of closed seasons. In addition, even the language of the Mexico treaty that addresses the need for domestic regulation prohibiting certain activities with respect to migratory birds is subject to the objective “to satisfy the need set forth in * * * Article[I].” Article I provides: “In order that the species may not be exterminated, the high contracting parties declare that it is right and proper to protect birds denominated as migratory, whatever may be their origin, which in their movements live temporarily in the United States of America and the United Mexican States, by means of adequate methods which will permit, in so far as the respective high contracting parties may see fit, the utilization of said birds rationally for purposes of sport, food, commerce and industry.” Therefore, to the extent that the Mexico treaty is interpreted to have application to take beyond hunting and the like, that treaty must also be interpreted to allow the parties to authorize take that is consistent with the needs set forth in Article I.

The broad language of the exceptions in the Japan, Russia, and Canada treaties clearly indicate that the intent of the parties was not to prohibit all take of migratory birds. Just as clearly, the take of large absolute numbers of birds (e.g. millions of birds taken in sport hunting) is allowable under the treaties, so long as that take is ultimately limited in a way that is consistent with the conservation principles and objectives of the treaties. Thus, allowing for take incidental to military readiness activities is, as a general matter, consistent with the conservation principles and objectives of all three of these treaties.

The Mexico treaty does not require the parties to prohibit incidental take, and therefore allowing take incidental to military readiness activities cannot conflict with the terms of that treaty. And even if that treaty was read to apply more broadly, it is clear that the parties intended it only to require the rational regulation of take, not an absolute prohibition. Allowing take incidental to military readiness activities is consistent with the needs set forth in Article I. More broadly, we conclude that any incidental take allowed under the broad exceptions of the other three treaties is consistent with the Mexico treaty.

Turning to the second question, whether this particular rule governing take incidental to military readiness activities is consistent with the treaties (and therefore the MBTA), the take that is authorized here is for a special purpose consistent with the principles and objectives of the treaties. The authorization allows take of birds only in limited instances—take that results from military readiness activities. Furthermore, the rule expressly requires the Armed Forces to develop conservation measures to minimize or mitigate impacts where such impacts may have a significant adverse effect on a population of a migratory bird species. Moreover, the Secretary must suspend the take authorization if he/she concludes that a specific military readiness activity likely would not be compatible with the migratory bird treaties and may withdraw the authorization if he/she is unable to obtain from Armed Forces the information needed to assure compliance. Thus, the authorization in this rule in effect incorporates a safeguard that provides for compliance with the requirements of the treaties.

It is not entirely clear what level of effect on a migratory bird population would be required to constitute a violation of any of the treaties. It is clear, however, that the relatively minor (at a population level) amount of take caused by military readiness activities is exceedingly unlikely to constitute a possible violation, even in the absence of any safeguards. When combined with the procedural safeguards set forth in this rule, there is no reasonable chance that a violation of the treaties will occur under this rule. In these circumstances, the take that would be authorized by this rule is thus compatible with the terms of the treaties and consistent with the purposes of those treaties.

The rule's process of broad, automatic authorization subject to withdrawal is particularly appropriate to military readiness activities. First, as noted above, we expect that military readiness activities will rarely, if ever, have the broad impact that would lead to a significant adverse effect on a population of migratory bird species, even absent the conservation measures that the Armed Forces undertake voluntarily or pursuant to another statute, such as the ESA. Second, the Armed Forces, like other federal agencies, have a special role in ensuring that the United States complies with its obligations under the four migratory bird treaties, as evidenced by the Migratory Bird Executive Order 13186 (January 10, 2001). Like other Federal agencies, the Armed Forces strive not only to lessen detrimental effects of their actions on migratory birds but to actively promote the conservation of the resource and integrate conservation principles and practices into agency programs. Numerous internal programs and collaborative ventures among Federal agencies and non-Federal partners have contributed significantly to avian conservation. These efforts are grounded in the tenets of stewardship inherent in our treaty obligations. Third, given the importance of military readiness to national security, it is especially important not to create a complex process that, while perhaps useful in other contexts, might impede the timely carrying-out of military readiness activities.

This rule was developed in accordance with the Authorization Act, which created an interim period, during which the prohibitions on incidental take of migratory birds would not apply to military readiness activities, and required the development of regulations authorizing the incidental take of migratory birds associated with military readiness activities. This rule carries out the mandates of the Authorization Act. This rule authorizes take resulting from otherwise lawful military readiness activities subject to certain limitations and subject to withdrawal of the authorization to ensure consistency with the provisions of the treaties.

Regulatory Planning and Review (E.O. 12866). In accordance with the criteria in Executive Order 12866, this rule is a significant regulatory action. OMB makes the final determination of significance under Executive Order 12866.

a. Analysis indicates this rule will not have an annual economic effect of $100 million or adversely affect an economic sector, productivity, jobs, the environment, or other units of government. This rule is intended to benefit the Department of Defense, and all of its branches of the Armed Forces, by providing a mechanism to comply with the MBTA and the treaties. A full cost-benefit and economic analysis is not required.

This rule will not affect small businesses or other segments of the private sector. It applies only to the Armed Forces. Thus, any expenditure under this rule will accrue only to the national defense agencies. Our current regulations allow us to permit take of migratory birds only for limited types of activities. This rule authorizes take resulting from the military readiness activities of the Armed Forces, provided the Armed Forces comply with certain requirements to minimize or mitigate significant adverse effects on a population of a migratory bird species.

Analysis of the annual economic effect of this rule indicates that it will have de minimis effects for the following reasons. Without the rule, the Armed Forces could be subject to injunction by third parties via the APA for lack of authorization under the MBTA for incidental takes of migratory birds that might result from military readiness activities. This rule will enable the Armed Forces to alleviate costs associated with responding to litigation as well as costs associated with delays in military training. Furthermore, the rule is structured such that the Armed Forces are not required to apply for individual permits to authorize take for every individual military readiness activity. The take authorization is conveyed by this rule. This avoids potential costs associated with staff necessary to prepare and review applications for individual permits to authorize military readiness activities that may result in incidental take of migratory birds, and the costs that would be attendant to delay.

The principal annual economic cost to the Armed Forces will likely be related to costs associated with developing and implementing conservation measures to minimize or mitigate impacts from military readiness activities that may have a significant adverse effect on a population of a migratory bird species. However, we anticipate that this threshold of potential effects on a population has a low probability of occurring. The Armed Forces are already obligated to comply with a host of other environmental laws, such as NEPA, which requires them to assess impacts of their military readiness activities on migratory birds, endangered and threatened species, and other wildlife. Most of the requirements of this rule will be subsumed by these existing requirements.

With this rule, the Armed Forces will have a regulatory mechanism to enable the Armed Forces to effectively implement otherwise lawful military readiness activities. Without the rule, the Armed Forces might not be able to complete certain military readiness activities that could result in the take of migratory birds pending issuance of an MBTA take permit or resolution of any lawsuits.

b. This rule will not create serious inconsistencies or otherwise interfere with the actions of the Armed Forces, including those other than military readiness. The Armed Forces must already comply with numerous environmental laws intended to minimize impacts to wildlife.

c. This rule will not materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients. This rule does not have anything to do with such programs.

d. This rule raises novel legal or policy issues. This rule raises a novel policy issue in that it implements a new area of our program to carry out the MBTA. Under 50 CFR 21.27, the Service has the authority to issue special purpose permits for take that is otherwise outside the scope of the standard form permits of section 21. Special purpose permits may be issued for actions whereby take of migratory birds could result as an unintended consequence. However, the Service has previously issued such permits only in very limited circumstances.

Regulatory Flexibility Act. For the reasons discussed under Regulatory Planning and Review above, I certify that this rule will not have a significant economic effect on a substantial number of small entities as defined under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). A final Regulatory Flexibility Analysis is not required. Accordingly, a Small Entity Compliance Guide is not required.

Small Business Regulatory Enforcement Fairness Act. This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

a. Will not have an annual effect on the economy of $100 million or more.

b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

c. Will not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

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

a. This rule will not “significantly or uniquely” affect small governments. A Small Government Agency Plan is not required. We have determined and certified 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 government or private entities.

b. 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.

Takings. In accordance with Executive Order 12630, the rule does not have significant takings implications. A takings implication assessment is not required. The only effect of this rule is to authorize incidental takes of migratory birds by the Armed Forces as a result of military readiness activities. This rule will not result in the physical occupancy of property, the physical invasion of property, or the regulatory taking of any property.

Federalism. In accordance with Executive Order 13132, and based on the discussions in Regulatory Planning and Review above, this rule will not have significant Federalism effects. A Federalism assessment is not required. Due to the migratory nature of certain species of birds, and given the Federal Government's responsibility to implement the migratory bird treaties, Congress assigned the Federal Government responsibility over these species when it enacted the MBTA. This rule will not have a substantial direct effect on fiscal capacity, change the roles or responsibilities of Federal or State governments, or intrude on State policy or administration.

Civil Justice Reform. In accordance with Executive Order 12988, the Office of the Solicitor has determined that this rule will not unduly burden the judicial system and that it meets the requirements of sections 3(a) and 3(b)(2) of the Order. The intent of the rule is to relieve the Armed Forces and the judicial system from potential litigation resulting from potential take of migratory birds during military readiness activities. The Department of the Interior has certified to the Office of Management and Budget that this rule meets the applicable standards provided in Sections 3(a) and 3(b)(2) of Executive Order 12988.

Paperwork Reduction Act. This rule will not require any new information collections under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Under the Paperwork Reduction Act, we do not need to seek Office of Management and Budget (OMB) approval to collect information from current Federal employees, military personnel, military reservists, and members of the National Guard in their professional capacities. Because this rule will newly enable us to collect information only from employees of the Armed Forces in their professional capacity, we do not need to seek OMB approval under the Paperwork Reduction Act. In other cases, Federal agencies may not conduct or sponsor, and members of the public are not required to respond to, a collection of information unless it displays a currently valid OMB control number.

National Environmental Policy Act. We have determined that this rule is categorically excluded under the Department of the Interior's NEPA procedures in Part 516 of the Departmental Manual, Chapter 2, Appendix 1, Categorical Exclusion 1.10. Categorical Exclusion 1.10 applies to: “policies, directives, regulations, and guidelines of an administrative, financial, legal, technical or procedural nature and whose environmental effects are too broad, speculative, or conjectural to lend themselves to meaningful analysis and will later be subject to the NEPA process, either collectively or case-by-case.”

Military readiness activities of the Armed Forces occur across a broad geographic area covering a wide diversity of habitat types and potentially affecting a high diversity of migratory birds. Potential impacts on migratory birds will also vary spatially and temporally across the landscape. In addition, the specific type of military readiness activity will vary significantly among the Armed Forces, and the biological and geographical spectrum across which these activities may occur is potentially unique. Because of the broad spectrum of activities, their locations, habitat types, and migratory birds potentially present that may be affected by this rule, the potential impacts of military readiness activities conducted by the Armed Forces on the affected environment are too broad, speculative and conjectural to lend themselves to meaningful analysis. Thus, it is premature to examine potential impacts of the rule.

However, this determination does not diminish the responsibility of the Armed Forces to comply with NEPA and individual military readiness activities at issue will be subject to the NEPA process by the Armed Forces to evaluate any environmental impacts. Whenever the Armed Forces propose to undertake new military readiness activities or to adopt a new, or materially revised, Integrated Natural Resources Management Plan, and migratory bird species may be affected, the Armed Forces will consult with and obtain comments from the Service, an agency with “jurisdiction by law or special expertise,” upon their NEPA analysis. The NEPA analysis will include cumulative effects where applicable. In addition, if the potential for significant effects on migratory birds makes it appropriate, the Armed Forces may invite the Service to participate as a cooperating agency in the preparation of their NEPA analysis. Moreover, authorization under this rule requires that if a proposed military readiness activity may result in a significant adverse impact on a population of migratory bird species, the Armed Forces must confer and cooperate with the Service to develop and implement appropriate measures to minimize or mitigate these effects. The environmental consequences of the proposed military readiness activity, as well as the potential of any such measures to reduce the adverse effects of the proposed activity, would be covered in NEPA documentation prepared for the proposed action.

We have also determined that this authorization would not result in “extraordinary circumstances” whereby actions cannot be categorically excluded pursuant to 516 DM 2.3A(2). This rule only authorizes the incidental take of migratory birds (with limitations) as a result of military readiness activities. We are not authorizing the Armed Forces to implement military readiness activities that may have significant adverse impacts on natural resources, have highly controversial environment effects, or result in significant cumulative impacts. If an individual military readiness action by the Armed Forces or the cumulative impacts of multiple activities may result in such an impact, then the Armed Forces will be responsible for completing an environmental analysis in accordance with NEPA. We are also not authorizing the take of a federally listed or proposed species. The Armed Forces must still comply with the Endangered Species Act.

Furthermore, we expect that military readiness activities will rarely, if ever, have the broad impact that would lead to a significant adverse effect on a population of a migratory bird species, even absent the conservation measures that the Armed Forces undertakes voluntarily or pursuant to another statute. The Armed Forces also have an important role in ensuring that the United States complies with the four migratory bird treaties, the Endangered Species Act, and other applicable regulations for individual ongoing or proposed military readiness activities.

A copy of the Service's Categorical Exclusion determination is available upon request at the address indicated in the ADDRESSES section of this rule.

Government-to-Government Relationship with Tribes. In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), E.O. 13175, and 512 DM 2, we have evaluated possible effects on federally recognized Indian tribes and have determined that there are no effects. This rule applies only to military readiness activities carried out by the Armed Forces that take migratory birds. It will not interfere with the Tribes' ability to manage themselves or their funds.

Energy Effects. On May 18, 2001, the President issued Executive Order 13211 on regulations that significantly affect energy supply, distribution, or use. This Executive Order requires agencies to prepare Statements of Energy Effects when undertaking certain actions. As this rule is not expected to significantly affect energy supply, distribution, or use, this action is not a significant energy action, and no Statement of Energy Effects is required.