I. Background A. HERA

Effective July 30, 2008, Division A of HERA, Public Law No. 110-289, 122 Stat. 2654 (2008), created FHFA as an independent agency of the Federal Government. HERA transferred the supervisory and oversight responsibilities over the Federal National Mortgage Association (Fannie Mae), Federal Home Loan Mortgage Corporation (Freddie Mac) (collectively, Enterprises), the Banks, and the Bank System's Office of Finance, from the Office of Federal Housing Enterprise Oversight (OFHEO) and the Federal Housing Finance Board (FHFB), respectively, to FHFA. FHFA is responsible for ensuring that the Enterprises and the Banks operate in a safe and sound manner, including being capitalized adequately, and carry out their public policy missions, including fostering liquid, efficient, competitive, and resilient national housing finance markets. The Enterprises and the Banks continue to operate under regulations promulgated by OFHEO and FHFB until such regulations are superseded by regulations issued by FHFA. See HERA at sections 1302, 1312, 122 Stat. 2795, 2798.

Section 10(j) of the Federal Home Loan Bank Act (Bank Act) requires each Bank to establish an affordable housing program, the purpose of which is to enable a Bank's members to finance homeownership by households with incomes at or below 80 percent of the area median income (AMI) (low- or moderate-income households), and to finance the purchase, construction or rehabilitation of rental projects in which at least 20 percent of the units will be occupied by and affordable for households earning 50 percent or less of AMI (very low-income households). See 12 U.S.C. 1430(j)(1) and (2). The Bank Act requires each Bank to contribute 10 percent of its previous year's net earnings to its AHP annually, subject to a minimum annual combined contribution by the 12 Banks of $100 million. See 12 U.S.C. 1430(j)(5)(C). Section 1218 of HERA amended section 10(j) by adding a new section 10(j)(2)(C) which requires FHFA to allow the Banks until July 30, 2010, to use AHP homeownership set-aside funds to refinance low- or moderate-income households' first mortgage loans on their primary residences. See 12 U.S.C. 1430(j)(2)(C). The Director of FHFA must establish the percentage of set-aside funds eligible for this use by regulation.

The AHP regulation authorizes a Bank, in its discretion, to set aside a portion of its annual required AHP contribution to establish homeownership set-aside programs for the purpose of promoting homeownership for low- or moderate-income households. See 12 CFR 1291.6. Under the homeownership set-aside programs, a Bank may provide AHP direct subsidy (grants) to members to pay for down payment assistance, closing costs, and counseling costs in connection with a household's purchase of its primary residence, and for rehabilitation assistance in connection with a household's rehabilitation of an owner-occupied residence. See 12 CFR 1291.6(c)(4). Currently, a Bank may allocate up to the greater of $4.5 million or 35 percent of its annual required AHP contribution to homeownership set-aside programs in that year.

In January 2008, FHFB waived certain homeownership set-aside program provisions of the AHP regulation to allow the Federal Home Loan Bank of San Francisco (San Francisco Bank) to establish a temporary pilot program to provide AHP direct subsidy to enable eligible households with subprime or nontraditional loans held by a San Francisco Bank member or its affiliate to refinance or restructure the loans into affordable, long-term fixed-rate mortgages. See FHFB Resolution No. 2008-01 (Jan. 15, 2008). The authority expired on December 31, 2009, without funds being committed.

In April 2008, FHFB published a proposed rule that would have extended the temporary authority to use AHP set-aside funds for mortgage refinancing or restructuring to all 12 Banks. See 73 FR 20552 (Apr. 16, 2008). FHFB received 36 comments on the proposal. Commenters who supported use of AHP funds for refinancing recommended flexibility in the rules governing use of the funds so that the Banks and their members would be able to assist a greater number of borrowers in distress, including allowing the use of AHP set-aside funds in conjunction with other federal, state or local mortgage refinancing programs.

Before FHFB took final action on the proposed amendments to the AHP regulation, section 1218 of HERA added section 10(j)(2)(C) to the Bank Act. Title IV of Division A of HERA also required establishment of the Hope for Homeowners Program, a temporary mortgage refinancing program under the Federal Housing Administration (FHA), which will expire on September 30, 2011. To implement the requirements of section 1218 of HERA, on October 17, 2008, FHFA published an interim final rule (2008 interim final rule), which added new § 1291.6(f) to the AHP homeownership set-aside regulation authorizing the Banks, in their discretion, to temporarily establish an AHP set-aside refinancing program. See 73 FR 61660 (Oct. 17, 2008). Specifically, § 1291.6(f) authorized the Banks to provide AHP direct subsidy to their members to assist in the refinancing of low- or moderate-income homeowners' mortgage loans under the Hope for Homeowners Program through the use of AHP subsidy to reduce loan principal and pay FHA-approved closing costs. By linking the use of the AHP subsidy with the Hope for Homeowners Program, FHFA intended to leverage and enhance the effectiveness of each program, ensure that the full range of federal assistance to affected homeowners was available quickly, and provide the flexibility that the Banks and their members need to make the AHP refinancing program successful.

FHFA received 40 comments on the 2008 interim final rule. Thirteen commenters generally supported the use of AHP subsidies for refinancing households with unaffordable mortgages, but recommended a number of changes to the rule. The other 27 commenters opposed the use of AHP subsidies for refinancing, citing the ongoing, critical need for AHP homeownership set-aside subsidies to assist home purchases.

Based on public comments received on the 2008 interim final rule, and in light of continuing adverse conditions of the mortgage market, FHFA determined that in order for the AHP set-aside refinancing program to be implemented successfully for the benefit of the intended households, the scope of the program authority should be broadened and the Banks should have greater flexibility in implementing the program. Accordingly, on August 4, 2009, FHFA published an interim final rule (2009 interim final rule) that authorized the Banks to provide AHP direct subsidy to their members to assist in the refinancing of low- or moderate-income homeowners' mortgage loans under eligible targeted refinancing programs through the use of AHP subsidy to reduce loan principal and pay closing costs. See 74 FR 38514 (Aug. 4, 2009). By linking the use of the AHP subsidy with eligible targeted refinancing programs, including the Hope for Homeowners Program and the Administration's Home Affordable Refinance Program (HARP), FHFA intended to leverage and enhance the effectiveness of each program, ensure that the full range of federal, state and local government assistance to affected homeowners was available quickly, and provide the flexibility that the Banks and their members need to make the AHP refinancing program successful. Five Banks are offering refinancing set-aside programs as authorized under the 2009 interim final rule.

FHFA received 11 comment letters on the 2009 interim final rule, representing 12 commenters. 1 Commenters included: seven Banks; one Bank Advisory Council; and four trade associations. All 12 commenters supported the expanded use of AHP subsidies provided under the rule. All five Banks that are offering refinancing set-aside programs commented on the 2009 interim final rule. FHFA did not receive any comments that generally opposed the rule. The Analysis of the Final Rule section, below, discusses the comments expressed on particular subjects.

Section 1201 of HERA requires the FHFA Director to consider the differences between the Banks and the Enterprises in rulemakings that affect the Banks with respect to the Banks' cooperative ownership structure, mission of providing liquidity to members, affordable housing and community development mission, capital structure and joint and several liability. See 12 U.S.C. 4513(f). In preparing the final rule, the Director considered these factors and determined that the rule is appropriate, particularly because the rule implements a statutory provision of the Bank Act that applies only to the Banks. See 12 U.S.C. 1430(j). FHFA did not receive any comments on whether these factors should result in a revision of the rule as it relates to the Banks.

The 2009 interim final rule provided that a household's loan is eligible to be refinanced with AHP direct subsidy if the loan is secured by a first mortgage on an owner-occupied unit that is the primary residence of the household, and the loan is refinanced under an “eligible targeted refinancing program.” An “eligible targeted refinancing program” is defined in § 1291.1 as a program offered by the Department of Housing and Urban Development (HUD), U.S. Department of Agriculture (USDA), Fannie Mae, Freddie Mac, a state or local government, or a state or local housing finance agency (HFA) for the limited purpose of refinancing first mortgages on primary residences for households that cannot afford or are at risk of not being able to afford their monthly payments, as defined by the program, in order to prevent foreclosure. This provision expanded the eligible targeted refinancing programs to include these other eligible targeted refinancing programs, in addition to the Hope for Homeowners Program included in the 2008 interim final rule.

Ten commenters specifically supported expanding the refinance set-aside eligibility to include these additional eligible targeted refinancing programs. No commenters opposed the expansion of the refinance set-aside authority to include these additional eligible targeted refinancing programs, and no commenters addressed the definition of “eligible targeted refinancing program.” Three commenters reiterated their comments on the 2008 interim final rule that FHFA should allow AHP subsidy to be used to restructure or refinance mortgages originated by members and purchased by the Banks for their Mortgage Partnership Finance and Mortgage Purchase Program portfolios. One commenter reiterated its previous comment on the 2008 interim final rule that members should also be able to use AHP subsidies to refinance loans in their portfolios with their own funds, within guidelines to be set by the Bank. Like the 2008 and 2009 interim final rules, the final rule does not authorize the use of AHP subsidy in conjunction with such private refinancing outside of eligible targeted refinancing programs for the reasons discussed in the 2009 interim final rule. One commenter suggested that the authority should be expanded to assist other troubled loan restructuring and modification initiatives; however, HERA authorizes AHP subsidies to be used for refinancing only. This temporary authority does not extend to use of the subsidies to assist in restructuring or modifying troubled loans without refinancing them into a new loan.

One commenter expressed concern that the regulation does not permit a Bank member to refinance its own mortgages that it has originated, even though it permits a member to refinance another member's mortgages. The 2009 interim final rule did not preclude a member from using AHP subsidy to assist households that have mortgages in the member's portfolio to be refinanced through an eligible targeted refinancing program. For example, a member that is a participating lender in a state HFA's bond program that is an eligible targeted refinancing program would be able to originate a mortgage under that bond program to refinance a mortgage in its own portfolio. However, as discussed in the 2009 interim final rule, FHFA rejected using AHP subsidy to assist members that are privately refinancing loans, whether in their portfolios or not, because of the regulatory, administrative and operational burdens of safeguarding the households and the AHP subsidies in such transactions.

The AHP regulation permits a Bank, in its discretion, to set aside annually, in the aggregate, a maximum of the greater of $4.5 million or 35 percent of its annual required AHP contribution to provide funds to members participating in homeownership set-aside programs, including mortgage refinancing programs established under § 1291.6(f). See 12 CFR 1291.2(b)(2)(i). The 2009 interim final rule amended the 2008 interim final rule to require that at least one-third of a Bank's aggregate annual set-aside allocation, including any set-aside allocation for a mortgage refinancing program, be targeted for first-time homebuyers. See id. As discussed in the 2009 interim final rule, in the current market where many existing homeowners are unable to sell their homes and purchase move-up homes because their mortgages exceed their homes' value, efforts to promote new home purchases could contribute to recovery and stabilization of the housing market. Ensuring that at least some portion of AHP set-aside subsidies are available for home purchase assistance is also consistent with HERA's establishment of Federal funding for the Neighborhood Stabilization Program (NSP), which provides funding to state and local government programs for purchasing, rehabilitating and renting or selling foreclosed properties. See HERA sections 2301 through 2305. A number of state HFAs are using NSP and mortgage-revenue bond funds to assist first-time homebuyers in purchasing these foreclosed properties.

Three commenters specifically supported applying the first-time homebuyers allocation requirement to a Bank's aggregate set-aside allocation, including allocations for both homeownership and set-aside refinancing programs. No commenters opposed this provision. The final rule does not change this provision.

Under the Bank Act, a Bank must contribute at least 10 percent of its prior year's net earnings to its current year's AHP. See 12 U.S.C. 1430(j)(5)(C). The 2009 interim final rule increased the maximum amount that a Bank, in its discretion, may reallot ( i.e., accelerate) from the subsequent year's required annual AHP contribution for use in the current year, to the greater of $5 million or 20 percent of the Bank's required annual AHP contribution for the current year. See 12 CFR 1291.2(b)(3). As discussed in the 2009 interim final rule, this provision was intended to address the fact that the Banks' earnings potential in the near future is uncertain and more unpredictable than in previous years because of market instability. The enhanced ability to account for accelerated funds from future required AHP contributions would facilitate the Banks making some amount of AHP funding available in the current year during the housing market and economic crisis even when they are uncertain about the amount of the subsequent year's earnings. In addition, because of the uncertainty of future earnings and the possibility that a Bank may find itself in the same situation of having little or no required AHP contribution in the subsequent year, the 2009 interim final rule allowed a Bank to credit the amount of the accelerated contribution against required AHP contributions over one or more of the subsequent five years. Four commenters specifically supported the amendments to the provision for accelerating future AHP contributions for use in the current year. No commenters opposed the amendments. This provision is unchanged in the final rule.

Section 1291.6(f)(1) authorizes a Bank, in its discretion, to establish a homeownership set-aside program for the use of AHP direct subsidy by its members to assist in the refinancing of a household's mortgage loan that meets the requirements in § 1291.6, except for certain specified provisions, as well as with the requirements of part 1291. The 2009 interim final rule required that a household assisted under the AHP set-aside refinancing program be subject to an AHP five-year retention agreement in accordance with § 1291.6(c)(5). As discussed in the 2009 interim final rule, under the Banks' current AHP competitive application and home purchase set-aside programs, AHP retention agreements, which may be subordinate liens or other forms of legally enforceable agreements, are used in conjunction with all types of mortgage financing provided by all federal, state and local agencies, including other FHA programs. Because the AHP regulation requires that AHP subsidy be repaid only from any net gain from the sale or refinancing of the home, the AHP repayment requirement should not interfere with any appreciation or equity sharing requirements of the eligible targeted refinancing programs. Requiring AHP retention agreements for the AHP set-aside refinancing program also maintains consistency between the refinancing program and all other AHP programs, which are subject to the retention agreement requirement.

Six commenters specifically supported the requirement for AHP retention agreements under the AHP set-aside refinancing program. One commenter opposed the retention agreement requirement for the AHP set-aside refinancing program because the retention agreement, which also applies to the AHP homeownership set-aside and competitive application programs, allows a household, under certain circumstances, to subsequently refinance and take out equity without repaying the AHP subsidy. FHFA does not see a reason to treat households obtaining AHP assistance under the set-aside refinancing program differently from households obtaining AHP assistance under the homeownership set-aside or competitive application programs with respect to the retention agreement requirements.

Accordingly, the final rule retains the AHP retention agreement requirement for the set-aside refinancing program.

As discussed above, the 2009 interim final rule amended § 1291.6(f)(2) to permit the use of AHP subsidy to assist households that need the subsidy in order to refinance their mortgages under eligible targeted refinancing programs. To be eligible for AHP refinancing assistance, a household must meet the terms of refinancing established by the eligible targeted refinancing program, such as the mortgage debt-to-income ratio, loan-to-value ratio, payment history, type of original loan ( e.g., subprime or nontraditional), and reasons for delinquency. 2 The requirements and standards of the other eligible targeted refinancing programs included in the 2009 interim final rule protect borrowers and the integrity of the AHP. Three commenters specifically supported this approach, which is unchanged in the final rule.

Section 1291.6(c)(2)(i) of the existing AHP regulation requires a Bank or member to determine a household's income eligibility at the time the member enrolls the household in the AHP homeownership set-aside program. Consistent with this requirement, the 2009 interim final rule provided that the Bank or member must determine that the household is at or below 80 percent of AMI at the time of enrollment in the AHP set-aside refinancing program. In addition, consistent with the AHP homeownership set-aside and competitive application programs, the 2009 interim final rule did not establish specific requirements for how a Bank should calculate a household's income. Thus, a Bank may make its own calculation of total household income, or may use the eligible targeted refinancing program's calculation of total household income. In this way, a Bank or member may rely on the total household income provided by the eligible targeted refinancing program regardless of when that program calculated the amount.

Four commenters specifically supported the provisions on calculation of household income, and no commenters opposed them. The final rule does not change these provisions.

The 2009 interim final rule permitted use of the AHP subsidy to reduce the outstanding loan principal balance to the eligible targeted refinancing program's maximum loan-to-value ratio even if this results in the household having a mortgage debt-to-income ratio below the program's maximum mortgage debt-to-income ratio. The maximum amount of AHP subsidy that may be provided for the refinancing is the least amount that results in the loan meeting both the program's maximum loan-to-value ratio and maximum mortgage debt-to-income ratio. See 12 CFR 1291.6(f)(3). The 2009 interim final rule also made a technical change to clarify that the applicable program underwriting debt-to-income ratio is the mortgage debt-to-income ratio. Three commenters specifically supported the amendment, which is unchanged in the final rule.

To maintain consistency with the AHP home purchase set-aside program, the 2009 interim final rule removed language in the 2008 interim final rule that restricted eligible closing costs under the set-aside refinancing program to FHA-approved closing costs. Two commenters specifically supported this change, and no commenters opposed it. The provision is unchanged in the final rule.

In addition, to maintain consistency with the AHP home purchase set-aside program, the 2009 interim final rule made applicable to the set-aside refinancing program the current requirement of the AHP home purchase set-aside program that the rate of interest, points, fees and any other charges for all loans made in conjunction with the AHP subsidy cannot exceed a reasonable market rate of interest, points, fees and other charges for loans of similar maturity, terms and risk. See 12 CFR 1291.6(c)(7). FHFA received no comments specifically addressing this provision, which is unchanged in the final rule.

The final rule includes a new provision that makes the payment of counseling costs for assisted households an eligible use of AHP subsidy under the set-aside refinancing program. In requiring counseling under the National Foreclosure Mitigation Counseling (NFMC) program, the 2009 interim final rule did not also authorize the use of AHP subsidies to pay for these counseling costs because counseling under the NFMC program is free to the households and, therefore, AHP subsidy is not needed to pay for the counseling. However, NFMC counselors may charge a household for the cost of obtaining its credit report from a third party. Because the household's credit report is an integral part of foreclosure mitigation counseling and qualification of the household for an eligible targeted refinancing program, the cost of the credit report would be an eligible counseling cost under the AHP. In addition, it is possible that other counseling services used by state and local governments or HFAs for their eligible targeted refinancing programs, as authorized by this regulation, may charge the households for counseling. Consequently, in order to accommodate such cases, the final rule permits the use of AHP subsidy to pay for such counseling costs. This provision is also consistent with similar authorization under the AHP home purchase set-aside and competitive application programs.

Accordingly, § 1291.6(f)(3)(iii) of the final rule permits the use of AHP subsidy to pay for counseling costs to the household under the refinancing set-aside program where the costs are incurred in connection with counseling of homeowners that actually refinance their homes with AHP assistance under the AHP set-aside refinancing program, and the cost of the counseling has not been covered by another source, including the counseling organization, a funding source, or the member.

The 2009 interim final rule permitted any member, rather than only members that are FHA-approved lenders, to obtain AHP direct subsidy for the purpose of refinancing an eligible loan. As discussed in the 2009 interim final rule, relatively few Bank members are FHA-approved lenders and many Bank members participate in HFA mortgage-revenue bond programs and are Fannie Mae- and Freddie Mac-approved sellers/servicers. AHP assistance should be available to households based on their qualifications, regardless of whether the member providing the AHP subsidy is FHA-approved. In addition, requiring members to be FHA-approved is too restrictive since the rule permits the use of the AHP subsidy with other eligible targeted refinancing programs in addition to FHA's Hope for Homeowners Program. One commenter specifically supported this change, and no commenters were opposed. The final rule does not change this provision.

The 2009 interim final rule also removed the requirement in the 2008 interim final rule that a Bank must consult with its Advisory Council before determining that a household may use a lender other than a member of the Bank. In addition, § 1291.6(f)(4) of the 2009 interim final rule permitted the Banks the discretionary authority to require a household to obtain its refinancing loan through a member participating as a lender in the eligible targeted refinancing program that is providing the new mortgage to the household. 3 Three commenters specifically supported these changes, and no commenters opposed them. These changes are retained in the final rule.

Section 1291.6(f)(5) of the 2009 interim final rule required that, prior to enrollment in an AHP set-aside refinancing program, a household seeking AHP assistance must obtain counseling for foreclosure mitigation which would include whether the household qualifies for refinancing by an eligible targeted refinancing program, through the NFMC program or other counseling program used by a state or local government or HFA. 4 By using the counseling requirement as a gateway, Bank members would be able to manage enrollments and commitments of AHP subsidies to households that would be able to use the subsidies. Households determined by a counseling organization to qualify for refinancing under an eligible targeted refinancing program would then be referred to participating Bank members, who would enroll the households in the AHP set-aside refinancing program upon determination of their AHP income eligibility at the time of enrollment. If households contacted a Bank member directly, the member would refer the households to an NFMC program participant, or to a state or local government or HFA counseling program, which would determine whether the households were eligible to have their loans refinanced through an eligible targeted refinancing program before the member would enroll the households in the AHP refinancing set-aside program and commit AHP subsidy.

Much of the NFMC counseling is one-on-one, during which a counselor can determine if a household's loan can be refinanced by one of the eligible targeted refinancing programs and whether AHP subsidy will be needed in order for the household to obtain the refinancing. A primary purpose of the 2009 interim final rule amendment was to ensure that the household receives counseling on a variety of available refinancing options that are suitable for that household. For example, a lender, such as an FHA lender or Fannie Mae/Freddie Mac seller/servicer, may be able to determine if a household is eligible for refinancing under HARP, but is not likely to know if the household has other options if it is not eligible for HARP. Even if the household could not qualify for an eligible targeted refinancing program or would not be eligible for AHP assistance, the NFMC program participant would be able to review the household's individual circumstances and identify other refinancing options that could assist the household. Consequently, under the 2009 interim final rule, when a household contacts a member directly, the member would refer the household to the NFMC program participant or other state or local government or HFA counseling program participant, to determine the household's eligibility for refinancing.

In the 2009 interim final rule, FHFA specifically requested comment on whether a household should be required to obtain counseling for foreclosure mitigation including counseling on whether the household qualifies for refinancing by an eligible targeted refinancing program, prior to enrollment in the AHP set-aside refinancing program. Six commenters specifically supported the counseling requirement, but three of these commenters expressed concern about the requirement that the household obtain the counseling and a determination of whether the household can qualify for an eligible targeted refinancing program prior to being enrolled by a member in the AHP set-aside refinancing program. One of these commenters recommended that counseling be required prior to the transfer of AHP subsidies committed to the household, rather than prior to enrollment. Two of the commenters also expressed concerns about access to in-person counseling for rural households. One commenter recommended that rural households or households with limited access to counseling be referred by members directly to eligible targeted refinancing programs for eligibility determinations until such counseling can be made available to the household. The 2009 interim final rule did not require in-person counseling because the NFMC program provides one-on-one counseling, often by telephone through a toll-free number accessible to rural households, which FHFA deemed to be sufficient in lieu of in-person counseling.

One commenter opposed the requirement that a household obtain the counseling and determination of whether the household qualifies for an eligible targeted refinancing program through the NFMC program. This commenter supported allowing Bank members to provide the counseling to determine if a household could qualify for refinancing under an eligible targeted refinancing program. In establishing the counseling requirement in the 2009 interim final rule, FHFA was concerned that it would be administratively unworkable for members to enroll, and commit AHP subsidy to, any number of households seeking assistance from the AHP set-aside refinancing program without knowing whether such households could obtain refinancing through an eligible targeted refinancing program. FHFA also recognized that the AHP set-aside refinancing program is designed to assist households that could not otherwise qualify for an eligible targeted refinancing program on their own without some amount of AHP subsidy. The nature of the AHP set-aside refinancing program, where AHP subsidy would be used for principal reduction, is such that a household needing AHP subsidy cannot qualify for refinancing under an eligible targeted refinancing program without the AHP subsidy. Consequently, where a household is seeking refinancing eligibility information directly from an eligible targeted refinancing program, a representative of that eligible targeted refinancing program, if unaware of the potential assistance of the AHP refinancing set-aside program, would likely tell the household that it does not qualify for refinancing under that program, thereby ending the household's efforts to refinance. An NFMC program counselor would be aware of the availability of the AHP set-aside refinancing program and have the capacity to sit down with an individual household to determine whether and how the household would be able to qualify under an eligible targeted refinancing program's eligibility and underwriting requirements if it had AHP or other subsidy assistance.

Nevertheless, FHFA recognizes that members may be prepared to accept the responsibility of working with individual households to identify available alternative eligible targeted refinancing programs and their respective eligibility and underwriting requirements, and to go through the process of calculating whether AHP subsidy assistance would allow the households to qualify for one of these eligible targeted refinancing programs. Consequently, § 1291.6(f)(5)(ii) of the final rule permits a Bank, in its discretion, to allow its members to refer potential household applicants for AHP assistance directly to an eligible targeted refinancing program for a determination on the households' eligibility for refinancing under that program, or to allow its members to determine, prior to counseling, whether household applicants for AHP assistance could qualify, in conjunction with AHP subsidy, for refinancing under available eligible targeted refinancing programs. At the same time, the final rule continues to require that the household obtain foreclosure mitigation counseling through an NFMC program or other counseling program used by a state or local government or HFA. Nevertheless, the final rule permits a Bank, in its discretion, to allow members to enroll households in the AHP set-aside refinancing program prior to counseling. In all cases, the household must obtain the counseling prior to disbursement of the AHP subsidy on behalf of the household.

The 2009 interim final rule provided that the Banks' authority to commit AHP subsidy for refinancing terminates after July 30, 2010, which is the expiration date of the two-year period in section 1218 of HERA. FHFA further stated that it may consider an extension of the sunset date in the future should program experience appear to justify such an extension.

Three commenters supported an extension of the sunset date, with one commenter suggesting September 30, 2011 to coincide with the sunset date for the Hope for Homeowners Program ( see HERA, section 1402(a) (National Housing Act sec. 257(r))), one commenter suggesting at least December 31, 2010, and one commenter suggesting no specific date. Of the five Banks that are offering a refinancing set-aside program, two did not address the sunset date, two supported FHFA's leaving open the possibility of an extension, and one supported an extension to December 31, 2010.

The final rule retains the sunset date of July 30, 2010 in § 1291.6(f)(6). However, the final rule makes two changes in order to accommodate operational procedures. First, under the homeownership set-aside program, Banks may commit available AHP subsidies in one of two ways. Some Banks commit AHP subsidies under their set-aside programs on an individual household basis as each household is enrolled by a member. Other Banks operate their homeownership set-aside programs using a model in which the Bank commits AHP subsidies on a member-basis, with the Bank committing a specified amount of AHP subsidies to an individual member which that member then uses to commit to individual households as the member enrolls them. The final rule amends § 1291.6(f)(6) to recognize both operational models for set-aside commitments by providing that a Bank may commit AHP subsidy to members or households under its AHP set-aside refinancing program until July 30, 2010.

Second, in light of the amendment permitting Banks to commit AHP subsidies to specific members up until the sunset date and in order to accommodate amendments in the final rule that allow the Banks more flexibility in permitting their members to enroll, and commit AHP subsidies to, households prior to counseling, or to determine whether households could qualify for an eligible targeted refinancing program, the final rule extends the date by which households must have submitted applications for refinancing to an eligible targeted refinancing program from July 30, 2010 to December 31, 2010. The final rule also clarifies that a member may use committed subsidy for a loan submitted to an eligible targeted refinancing program prior to December 31, 2010, that is approved subsequent to December 31, 2010.

The 2009 interim final rule amended § 1291.5(d)(5)(vii) of the AHP regulation to permit a Bank to establish one or more housing needs in the Bank's district under the Second District Priority scoring criterion, which is used in scoring applications under the AHP competitive application program. The amendment was intended primarily to provide more flexibility in the Banks' capacity to respond to the current housing crisis by allowing the AHP competitive application program to complement the efforts of the AHP set-aside refinancing program and other targeted refinancing programs for foreclosure prevention and HERA's NSP for the disposition of foreclosed properties. FHFA specifically requested comments on whether this scoring change benefits the AHP competitive application program.

Eight commenters specifically supported this amendment, citing the importance of the additional flexibility for the Banks to use their competitive application programs to address a variety of housing needs in their respective districts. FHFA received no comments opposing this amendment, which is unchanged in the final rule.

Pursuant to the Administrative Procedures Act, FHFA for good cause finds that the effective date of the final rule should not be delayed for 30 days and that the final rule should become effective on May 28, 2010. See 5 U.S.C. 553(d)(3). Section 1218 of HERA requires that FHFA's regulations authorize the use of AHP set-aside subsidy for mortgage refinancing for a two-year period commencing on July 30, 2008, with a resulting sunset date of July 30, 2010. The final rule retains the substance of FHFA's August 4, 2009 interim final rule currently in effect, while amending the regulation to allow the Banks to make administrative changes to the AHP set-aside refinancing program designed to facilitate household participation in the program. Making the final rule effective immediately will enable the Banks to expedite implementation of these program administrative changes. A 30-day delayed effective date could adversely impact households who, as a result of the flexibility of the program administrative changes, could have received the AHP subsidy commitment needed to qualify for an eligible targeted refinancing program or closed on their refinancing mortgage during the 30-day period.

The final rule does not substantively or materially modify the approved information collection entitled “Affordable Housing Program (AHP),” which is assigned control number 2590-0007 by the Office of Management and Budget (OMB). See http://www.fhfa.gov/webfiles/13095/AHP_Data_Reporting_Instructions.pdf.

Consequently, FHFA has not submitted any information to OMB for review under the Paperwork Reduction Act of 1995. See 44 U.S.C. 3501 et seq.

Because no notice of proposed rulemaking is required for this final rule, the provisions of the Regulatory Flexibility Act do not apply. See 5 U.S.C. 601(2) and 603(a). Moreover, the final rule applies only to the Banks, which do not come within the meaning of “small entities,” as defined in the Regulatory Flexibility Act. See id. sec. 601(6).

The Entity List provides notice to the public that certain exports, reexports, and transfers (in-country) to entities identified on the Entity List require a license from the Bureau of Industry and Security (BIS) and that availability of license exceptions in such transactions is limited. Entities are placed on the Entity List on the basis of certain sections of part 744 (Control Policy: End-User and End-Use Based) of the EAR.

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

This rule amends the Export Administration Regulations (EAR) to implement changes to the Entity List (Supplement No. 4 to part 744) on the basis of the 2009 annual review of the Entity List conducted by the ERC, in accordance with the procedures outlined in Supplement No. 5 to part 744 (Procedures for End-User Review Committee Entity List Decisions).

As of January 1, 2009, entities on the Entity List were listed under one or more of eighteen different destinations. The changes from the 2009 annual review of the Entity List that were approved by the ERC will be implemented in two rules. The first rule published today implements the results of the annual review for listed entities under eleven destinations on the Entity List: Canada, Egypt, Germany, Hong Kong, Israel, Kuwait, Lebanon, Malaysia, South Korea, Singapore, and the United Kingdom. The second rule will implement the results of the annual review for entities listed under the remaining seven destinations: China, India, Iran, Pakistan, Russia, Syria, and the United Arab Emirates. Entities listed under the destinations of Armenia, Ireland or Taiwan were not included in the 2009 annual review because they were added to the Entity List in 2009 or 2010.

This rule removes one entity from the Entity List under Hong Kong. This rule also makes two modifications to the Entity List: by making a correction to the address of one entity listed under Egypt, and by making a clarification to the license requirement for one entity listed under Israel. On the basis of the 2009 annual review, no additional changes will be made to listed entities under the following eight destinations: Canada, Germany, Kuwait, Lebanon, Malaysia, South Korea, Singapore, and the United Kingdom.

The entity being removed from the Entity List is located in Hong Kong:

(1) Speedy Electronics Ltd., 1206-7, 12/F New Victory House, Hong Kong.

The removal of Speedy Electronics Ltd. from the Entity List (from Hong Kong, as described above) eliminates the existing license requirement in Supplement No. 4 to part 744 for exports, reexports and transfers (in-country) to this entity. However, the removal of Speedy Electronics Ltd. from the Entity List does not relieve persons of other obligations under part 744 of the EAR or under other parts of the EAR. Neither the removal of an entity from the Entity List nor the removal of Entity List-based license requirements relieves persons of their obligations under General Prohibition 5 in § 736.2(b)(5) of the EAR which provides that, “you may not, without a license, knowingly export or reexport any item subject to the EAR to an end-user or end-use that is prohibited by part 744 of the EAR.” Nor do such removals relieve persons of their obligation to apply for export, reexport or in-country transfer licenses required by other provisions of the EAR. BIS strongly urges the use of Supplement No. 3 to part 732 of the EAR, “BIS's `Know Your Customer' Guidance and Red Flags,” when persons are involved in transactions that are subject to the EAR.

(1) This rule amends one Egyptian entry currently on the Entity List by adding an additional address for the entity listed, as follows:

H Logic, Behind 14 Mahmoud Sedky St., El Ekbal, Alexandria, Egypt; and 11 Abd El-Hamid Shoman St., Nasser City, Cairo.

A BIS license is required for the export, reexport or transfer (in-country) of any item subject to the EAR to H Logic, including any transaction in which this listed entity will act as purchaser, intermediate consignee, ultimate consignee, or end-user of the items. This listing of this entity also prohibits the use of license exceptions ( see part 740 of the EAR) for exports, reexports and transfers (in-country) of items subject to the EAR involving this entity.

(2) Finally, this rule amends one Israeli entry currently on the Entity List ( i.e., Ben Gurion University) by revising the license requirement for the entity listed. This change was needed because the license requirement for this listed entity prior to publication of this rule was based on a section of the EAR that is no longer in the EAR ( i.e., Section 742.12 (High Performance Computers)). This section of the EAR was removed and reserved on April 24, 2006 (71 FR 20876). To conform to the April 2006 change and to clarify the Entity List based license requirement for this listed entity, this rule is revising the license requirement to indicate the license requirement applies to computers above the Tier 3 level described in Section 740.7(d) of License APP (Computers). The entity column and the revision to the license requirement column for this listed entity is, as follows:

Ben Gurion University, Israel.

For computers above the Tier 3 level described in Section 740.7(d) ( i.e., Tier 3 under APP).

A BIS license is required for the export, reexport or transfer (in-country) of any computers above the Tier 3 level described in Section 740.7(d) ( i.e., Tier 3 under APP) subject to the EAR to Ben Gurion University, including any transaction in which this listed entity will act as purchaser, intermediate consignee, ultimate consignee, or end-user of the items. This listing of this entity also prohibits the use of license exceptions (see part 740 of the EAR) for exports, reexports and transfers (in-country) of these types of computers subject to the EAR involving this entity.

Shipments of items removed from eligibility for a License Exception or export or reexport without a license (NLR) as a result of this regulatory action that were on dock for loading, on lighter, laden aboard an exporting or reexporting carrier, or en route aboard a carrier to a port of export or reexport, on May 28, 2010 pursuant to actual orders for export or reexport to a foreign destination, may proceed to that destination under the previous eligibility for a License Exception or export or reexport without a license (NLR) so long as they are exported or reexported before June 28, 2010. Any such items not actually exported or reexported before midnight, on June 28, 2010, require a license in accordance with this rule.

Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as extended by the Notice of August 13, 2009, 74 FR 41325 (August 14, 2009), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act.

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

2. Notwithstanding any other provision of law, no person is required to respond to nor be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et. seq. ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves collections previously approved by the OMB under control numbers 0694-0088, “Multi-Purpose Application,” which carries a burden hour estimate of 58 minutes to prepare and submit form BIS-748. Miscellaneous and recordkeeping activities account for 12 minutes per submission. Total burden hours associated with the Paperwork Reduction Act and Office and Management and Budget control number 0694-0088 are expected to increase slightly as a result of this rule.

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

4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military or foreign affairs function of the United States. ( See 5 U.S.C. 553(a)(1)). Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et. seq., are not applicable.

Regulatory Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because delaying the effective date would be contrary to the public interest since immediate action is needed to ensure the public's safety during the 34th Annual Norfolk Harborfest Celebration.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date would be contrary to the public interest since immediate action is needed to ensure the public's safety during 34th Annual Norfolk Harborfest Celebration.

Marine events are frequently held on the navigable waters within the boundary of the Fifth Coast Guard District. The on water activities that typically comprise marine events include sailing regattas, power boat races, swim races and holiday boat parades. For a description of the geographical area of each Coast Guard Sector—Captain of the Port Zone, please see 33 CFR 3.25.

This regulation temporarily changes the enforcement period of special local regulations for recurring marine events within the Fifth Coast Guard District. This regulation applies to one marine event in 33 CFR 100.501, Table to § 100.501.

On June 11, 12, and 13, 2010, Norfolk Festevents Ltd. will sponsor the “34th Annual Norfolk Harborfest Celebration” on the waters of the Southern Branch of the Elizabeth River near Norfolk, Virginia. The regulation at 33 CFR 100.501 is effective annually for this marine event. The event will consist of several boat races and parades on the Southern Branch of the Elizabeth River in the vicinity of Town Point Reach, Norfolk, Virginia. A fleet of spectator vessels is expected to gather near the event site to view the competition. To provide for the safety of participants, spectators, support and transiting vessels, the Coast Guard will temporarily restrict vessel traffic in the event area during the river boat races and parade. The regulation at 33 CFR 100.501 would be enforced for the duration of the event. Under provisions of 33 CFR 100.501, on June 11, 12, and 13, 2010, vessels may not enter the regulated area unless they receive permission from the Coast Guard Patrol Commander.

The Coast Guard is establishing a temporary special local regulation on specified waters of the Southern Branch, Elizabeth River, near Norfolk, Virginia. The regulated area will be established in the interest of public safety during the 34th Annual Norfolk Harborfest Celebration, and will be enforced on June 11, 12, and 13, 2010. Access to the regulated area will be restricted during the specified dates or until the river boat races and parades are complete, whichever is sooner. Except for participants and vessels authorized by the Captain of the Port or his Representative, no person or vessel may enter or remain in the regulated area.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

Although this rule prevents traffic from transiting a portion of certain waterways during specified events, the effect of this regulation will not be significant due to the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via marine information broadcasts, local radio stations and area newspapers so mariners can adjust their plans accordingly. Additionally, this rulemaking does not change the permanent regulated areas that have been published in 33 CFR 100.501, Table to § 100.501. In some cases vessel traffic may be able to transit the regulated area when the Coast Guard Patrol Commander deems it is safe to do so.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule would affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in the areas where marine events are being held. This regulation will not have a significant impact on a substantial number of small entities because it will be enforced only during marine events that have been permitted by the Coast Guard Captain of the Port. The Captain of the Port will ensure that small entities are able to operate in the areas where events are occurring when it is safe to do so. In some cases, vessels will be able to safely transit around the regulated area at various times, and, with the permission of the Patrol Commander, vessels may transit through the regulated area. Before the enforcement period, the Coast Guard will issue maritime advisories so mariners can adjust their plans accordingly.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.

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

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

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

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(h), of the Instruction. This rule involves implementation of regulations within 33 CFR Part 100 that apply to organized marine events on the navigable waters of the United States that may have potential for negative impact on the safety or other interest of waterway users and shore side activities in the event area. The category of water activities includes but is not limited to sail boat regattas, boat parades, power boat racing, swimming events, crew racing, and sail board racing.

Under figure 2-1, paragraph (34)(h), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule.

Regulatory Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the potential dangers posed by vessel traffic operating in close proximity to high speed power boats makes special local regulations necessary to provide for the safety of participants, event support vessels, spectator craft and other vessels. Delaying the effective date would be contrary to the public interest, since immediate action is needed to ensure the safety of the event participants, patrol vessels, spectator craft and other vessels transiting the event area. For these reasons, it is in the public interest to have these regulations in effect during the event. The Coast Guard will issue broadcast notice to mariners to advise vessel operators of navigational restrictions. On scene Coast Guard and local law enforcement vessels will also provide actual notice to mariners.

For the same reasons, the Coast Guard also finds under 5 U.S.C. 553(d)(3) that good cause exists for making this rule effective less than 30 days after publication in the Federal Register.

This regulation temporarily changes the enforcement period of special local regulations for a recurring marine event in 33 CFR 100.501 and 33 CFR Table to § 100.501, No. 54. On June 5 and 6, 2010, Carolina Cup Regatta, Inc. will sponsor the 2010 International Cup Regatta hydroplane races on the waters of the Pasquotank River adjacent to Elizabeth City, North Carolina. The event will consist of approximately 75 hydroplane powerboats conducting high-speed competitive races on the Pasquotank River from shoreline to shoreline in the vicinity of the Elizabeth City Waterfront, Elizabeth City, North Carolina. A fleet of spectator vessels is expected to gather near the event site to view the competition.

The regulation at 33 CFR 100.501 and 33 CFR Table to 100.501 is effective annually for this marine event on the second Saturday and Sunday of June, which is June 12 and 13 this year. Because the dates of the event this year differ from the effective dates in the CFR, this rule temporarily changes the effective dates of the existing regulation. To provide for the safety of participants, spectators, support and transiting vessels, the Coast Guard will temporarily restrict vessel traffic in the event area during the hydroplane races. The existing regulation in the CFR will be enforced for the duration of the event this year on June 5 and 6 instead of June 12 and 13.

The Coast Guard is temporarily changing the effective dates of special local regulations, in 33 CFR Table to 100.501, No. 54, for the 2010 International Cup Regatta from “June—2nd Saturday and Sunday” to “June—1st Saturday and Sunday” because the regatta will be held on the latter dates this year. The temporary special local regulations in 33 CFR 100.501 will be enforced from 9 a.m. to 6:30 p.m. on June 5 and June 6, 2010, and will restrict general navigation in the regulated area described in 33 CFR Table to 100.501, No. 54. The name of the event has also changed this year from the Carolina Cup Regatta to the 2010 International Cup Regatta, and the event sponsor's name has changed from the Virginia Boat Racing Association to Carolina Cup Regatta, Inc. Except for participants and vessels authorized by the Coast Guard Patrol Commander, no person or vessel will be allowed to enter or remain in the regulated area. These regulations are needed to control vessel traffic during the event to enhance the safety of participants, spectators and transiting vessels.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

Although this rule prevents traffic from transiting a portion of the Pasquotank River during the event, the effect of this regulation will not be significant due to the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via marine information broadcasts, local radio stations and area newspapers so mariners can adjust their plans accordingly. Additionally, this rulemaking does not change the permanent regulated areas that have been published in 33 CFR 100.501, Table to § 100.501. In some cases vessel traffic may be able to transit the regulated area when the Coast Guard Patrol Commander deems it is safe to do so.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule would affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in the Pasquotank River in the regulated area. This regulation will not have a significant impact on a substantial number of small entities because it will be enforced only in a limited area for a short duration. The Captain of the Port will ensure that small entities are able to operate in the areas where events are occurring when it is safe to do so. In some cases, vessels will be able to safely transit around the regulated area and, with the permission of the Patrol Commander, vessels may transit through the regulated area. Before the enforcement period, the Coast Guard will issue maritime advisories so mariners can adjust their plans accordingly.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.

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

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

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

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(h), of the Instruction because the rule involves promulgation of special local regulations issued in conjunction with a regatta or marine parade.

Under figure 2-1, paragraph (34)(h), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule.

Regulatory Information

On July 8, 2009 we published an Interim Rule with a request for comments entitled, Special Local Regulation, Maggie Fischer Memorial Great South Bay Cross Bay Swim, Great South Bay, NY, in the Federal Register (74 FR 32428). We did not receive any comments or requests for meetings in response to the Interim Rule.

The Cross Bay Swim has been successfully held off and on from the early 1900's on the waters of Great South Bay, NY. This 5.25 mile swim has historically involved up to 100 swimmers and accompanying safety craft that travel along a course located directly north of the Fire Island Lighthouse Dock, NY and extending to Gilbert Park in Brightwaters, NY. Prior to this rule there was not a regulation in place to protect the swimmers or safety craft from the hazards imposed by marine traffic.

To ensure the continued safety of the swimmers, safety craft and the boating public, the Coast Guard is establishing a permanent special local regulation on the navigable waters of the Great South Bay, New York that would exclude all unauthorized persons and vessels from approaching within 100 yards of any swimmer or safety craft on the race course from 6:30 a.m. to 12:30 p.m. on the day of the race.

Entry into this zone is prohibited unless authorized by the Captain of the Port Long Island Sound or by designated on-scene patrol personnel. Any violation of the safety zone described herein is punishable by, among other things, civil and criminal penalties, in rem liability against the offending vessel, and the initiation of suspension or revocation proceedings against Coast Guard-issued merchant mariner credentials.

A small number of changes are being made to minimize the size of the regulated area and reduce the burden on vessel traffic by minimizing the restrictions in the regulated area. Even though the bounds of the regulated area were discussed in the Small Entities section, and no comments were received, we are clarifying sections (a) and (c) to read as set forth in the regulatory text of this final rule.

The changes in the text redefined the regulated area from “within 100 yards of the swim event race course” to “within 100 yards from each swimmer or safety craft on the swim event race course” so the regulated area would not block the entire waterway. This will reduce the burden on vessels by allowing them to pass through the race course as long as they stay clear of the swimmers and safety craft.

Also, paragraph (d) has been revised to provide the public additional notice of enforcement dates and times through publication of an advance notice each year in the Federal Register.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit in those portions of Great South Bay, NY covered by the special local regulation. Although the safety zone would apply to the entire width of the bay, traffic would be allowed to pass through the zone, outside 100 yards of any swimmer or safety craft. Before the activation of the zone, we would issue maritime advisories widely available to users of the waterway. Additionally, the rule would only be in effect for a period of 6-7 hours for one day per year.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), in the Interim Rule we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process.

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

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

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

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(h), of the Instruction. This rule finalizes the establishment of a special local regulation that was published as an Interim Rule with an invitation to comment on July 8, 2009. No comments were received that would affect the assessment of environmental impacts from this action. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES.

Currently, customers can apply for BRM permits and QBRM authorization online or in person at any Post Office TM facility. The ability to obtain a BRM permit online has been available since 2004 and has not sustained the volume of users to support maintaining the system.

Beginning May 2010, the ability to obtain a BRM permit online will be eliminated and customers will be required to visit a Post Office and submit a completed hardcopy PS Form 3615, Mailing Permit Application and Customer Profile, to obtain a BRM permit. In addition, customers requesting authorization for QBRM will also be required to visit a Post Office to complete a printed PS Form 6805.

The Postal Service adopts the following changes to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), incorporated by reference in the Code of Federal Regulations. See 39 CFR 111.1.

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

EPA's Phase 1 8-hour ozone implementation rule, published on April 30, 2004 (69 FR 23951), referred to as the Phase 1 Rule, specifies that states must submit attainment demonstrations to EPA by no later than three years from the effective date of designation, that is, submit them by June 15, 2007.

On November 9, 2005, EPA published Phase 2 of the 8-hour ozone implementation rule (70 FR 71612), referred to as the Phase 2 Rule, which addressed the control obligations that apply to areas designated nonattainment for the 8-hour national ambient air quality standard. Among other things, the Phase 1 and Phase 2 Rules outline the SIP requirements and deadlines for various requirements in areas designated as moderate nonattainment. For such areas, reasonably available control technology (RACT) plans were due by September 2006 (40 CFR 51.912(a)(2)). The rules further require that modeling and attainment demonstrations, reasonable further progress plans, reasonably available control measure (RACM) analysis, projection year emission inventories, motor vehicle emissions budgets and contingency measures were all due by June 15, 2007 (40 CFR 51.908(a), and (c)).

On October 21, 2009 and November 23, 2009, the New York State Department of Environmental Conservation (NYSDEC), submitted to EPA proposed revisions to the SIP which included State adopted revisions to two regulations which consist of, respectively, Title 6 of the New York Code of Rules and Regulations (6 NYCRR) Part 235, “Consumer Products” with a State effective date of October 15, 2009 and 6 NYCRR Part 239, “Portable Fuel Container Spillage Control” with a State effective date of July 30, 2009. These revisions will provide volatile organic compound (VOC) emission reductions to address, in part, attainment of the 1997 8-hour ozone standard in the New York portion of the New York-Northern New Jersey-Long Island, NY-NJ-CT nonattainment area which is composed of the five boroughs of New York City and the surrounding counties of Nassau, Suffolk, Westchester and Rockland. These revisions will also address, in part, the RACT and RACM requirements by providing VOC emission reductions statewide.

On March 2, 2010 (75 FR 9373), EPA proposed to approve the proposed revisions to the New York SIP for ozone concerning the amendments to 6 NYCRR Parts 235 and 239. The reader is referred to that proposal for a more detailed discussion of this action. No comments were received in response to that proposal.

EPA has evaluated New York's submittal for consistency with the Clean Air Act, EPA regulations, and EPA policy. EPA has determined that the revisions made to Part 235 and Part 239 of Title 6 of the New York Codes, Rules and Regulations, entitled, “Consumer Products” and “Portable Fuel Container Spillage Control,” respectively, meet the SIP revision requirements of the Clean Air Act with the following exceptions.

The provisions related to innovative products exemptions in subpart 239-5, variances in subpart 239-7 and alternate test methods in subpart 239-8 do not explicitly require submission of an innovative product exemption, variance or alternative test method to EPA for approval into the SIP. Since the rule does not explicitly state that innovative product exemptions, variances or alternative test methods have to be submitted to EPA for approval in the SIP, there is the possibility that such exemptions, variances and alternatives will not be submitted for review and approval into the SIP and therefore will not, even though approved by the State, become federally enforceable. Failure to submit such exemptions, variances or alternatives to EPA for review and approval can lead to sources not understanding that the original rule still applies and can be enforced by the United States. In order to be federally enforceable, any exemption, variance or alternative test method approved by NYSDEC must be approved by EPA into the SIP.

Therefore, EPA is approving the proposed revisions to Part 239, “Portable Fuel Container Spillage Control” with a State effective date of July 30, 2009, as part of the New York SIP with the understanding that the specific application of provisions associated with innovative product exemptions, variances, and alternate test methods, pursuant to Part 239, must be submitted to EPA as SIP revisions. EPA is also approving the proposed revisions to Part 235, “Consumer Products” with a State effective date of October 15, 2009, as part of the New York SIP.

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

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

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

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

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

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

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

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

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

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

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 27, 2010. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

Citizens concerned with water quality in Pennsylvania may be interested in this rulemaking. Entities discharging pollutants to the surface waters of Pennsylvania could be indirectly affected by this rulemaking since water quality standards are used in determining National Pollutant Discharge Elimination System (NPDES) permit limits. Because this action withdraws a redundant Federal antidegradation policy, the effect of this rulemaking should be insignificant. Categories and entities which may ultimately be affected include:

Section 303 (33 U.S.C. 1313) of the Clean Water Act (CWA or Act) directs States, with oversight by EPA, to adopt water quality standards to protect the public health and welfare, enhance the quality of water and serve the purposes of the CWA. Under section 303, States are required to develop water quality standards for their navigable waters, and Section 303(c) and EPA's implementing regulations at 40 CFR part 131 require State and Tribal water quality standards to include the designated use or uses to be made of the waters, water quality criteria sufficient to protect those uses, and an antidegradation policy. Under the CWA and EPA's regulations, States are required to review their water quality standards at least once every three years and, if appropriate, revise or adopt new standards. The results of this triennial review must be submitted to EPA, and EPA must approve or disapprove any new or revised standards. Section 303(c) of the CWA authorizes the EPA Administrator to promulgate water quality standards to supersede State standards that EPA has disapproved or in any case where the Administrator determines that a new or revised standard is needed to meet the CWA's requirements.

In June 1994, EPA disapproved Pennsylvania's antidegradation regulation after determining the regulation was not consistent with the Federal antidegradation regulation found at 40 CFR 131.12. When the Pennsylvania Department of Environmental Protection (PADEP) did not act within the statutory timeframe to address EPA's findings, EPA promulgated a Federal antidegradation policy for all waters of the United States within the Commonwealth of Pennsylvania at 40 CFR 131.32 on December 9, 1996 (61 FR 64816). In August 1999, PADEP submitted to EPA revisions to its antidegradation policy found in 25 Pa. Code Chapter 93. On March 17, 2000, EPA approved most of the revisions to Pennsylvania's regulations as meeting the requirements of Federal regulations at 40 CFR 131.12(a)(1) and 131.12(a)(2), but withheld action on Section 93.4b, PADEP's Exceptional Value (EV) Waters designation, or Tier 3, until PADEP ensured that EV designated waters would be protected at the level consistent with Federal regulations at 40 CFR 131.12(a)(3). In 2003, PADEP published “Water Quality Antidegradation Implementation Guidance” (Document Number 391-0300-002). In it, PADEP provides guidance to its staff and information to help the regulated community and the public understand the implementation of the antidegradation policy in Pennsylvania. Based on a review of the document in combination with the PADEP's antidegradation regulation, EPA approved PADEP's antidegradation policy for Tier 3 waters on March 7, 2007. Because Pennsylvania now has an EPA-approved antidegradation policy meeting the Federal requirements at 40 CFR 131.12, the Federal antidegradation regulation promulgated by EPA for Pennsylvania is no longer needed and EPA is withdrawing it with this action.

This action withdraws Federal requirements applicable in Pennsylvania and imposes no regulatory requirements or costs on any person or entity. It does not interfere with the action or planned action of another agency, and does not have any budgetary impacts or raise novel legal or policy issues. Thus, it has been determined that this rule is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to Office of Management and Budget (OMB) review.

This action does not impose any new information collection burden because it is administratively withdrawing Federal requirements that no longer need to apply in Pennsylvania. However, the Office of Management and Budget (OMB) has previously approved the information collection requirements contained in the existing regulations 40 CFR part 131 under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2040-0049. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, generally requires an agency to prepare a regulatory flexibility analysis of a rule that is subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. This action imposes no regulatory requirements or costs on any small entity. Therefore, I certify that this action will not have a significant impact on a substantial number of small entities.

Title III of the Unfunded Mandates Reform Act (UMRA) (Pub. L. 104-4) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, Tribal, and local governments and the private sector. Today's rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, Tribal, or local governments or the private sector because it imposes no enforceable duty on any of these entities. Thus, today's rule is not subject to the requirements of UMRA sections 202 and 205 for a written statement and small government agency plan.

Similarly, EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments and is therefore not subject to UMRA section 203.

This rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. Thus, Executive Order 13132 does not apply to this action.

This rule does not have Tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). This rule imposes no regulatory requirements or costs on any Tribal government. It does 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. Thus, Executive Order 13175 does not apply to this rule.

This rule is not subject to E.O. 13045, entitled “Protection of Children from Environmental Risks and Safety Risks” (62 FR 19885, April 23, 1997) because it is not economically significant and EPA has no reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children.

This action is not subject to Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not a significant regulatory action under Executive Order 12866.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104-113, 12(d) (15 U.S.C. 272 note), directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

The requirements of section 12(d) of the NTTAA do not apply because this rule does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.

EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. As explained above, EPA has approved Pennsylvania's antidegradation policy because it is consistent with 40 CFR 131.12. This rule withdraws a redundant antidegradation policy.

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. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective on June 28, 2010.

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 those engaged in the following activities:

• 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 to provide 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 .

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at www.gpoaccess.gov/ecfr .

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2009-0268 on the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before July 27, 2010. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2009-0268, 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 Facility'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 Facility telephone number is (703) 305-5805.

In the Federal Register of August 19, 2009 (74 FR 41898) (FRL-8426-7), 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 9F7527 and PP 9F7529 by BASF Corporation, Research Triangle Park, NC 27709. PP 9F7527, which was incorrectly written as PP 9F7529 in the notice, requested that 40 CFR 180.589 be amended by establishing tolerances for residues of the fungicide boscalid, 3-pyridinecarboxamide, 2-chloro- N -(4'-chloro[1,1′-biphenyl]-2-yl), in or on alfalfa, forage at 35 part per million (ppm); alfalfa, hay at 85 ppm; and citrus, crop group 10 at 2 ppm. PP 9F7529 requested to increase the existing tolerance in or on fruit, stone, group 12 from 1.7 ppm to 5 ppm. That notice referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket, http://www.regulations.gov . There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has revised several proposed tolerances and has determined that separate tolerances are necessary for citrus, dried pulp and citrus, oil. The Agency has also revised several established livestock commodities. Finally, EPA has revised the tolerance expression for all established commodities to be consistent with current Agency policy. The reasons for these changes are explained in Unit IV.C.

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

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in 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 for boscalid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with boscalid 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.

Boscalid has low acute toxicity via the oral, dermal, and inhalation routes of exposure, and it is not an eye or skin irritant. Following subchronic and chronic exposure to boscalid, the liver and thyroid appeared to be the target organs in several species. In mice, subchronic exposure to boscalid resulted in increased liver weights and an increased incidence of marked fatty changes in the liver. Subchronic and chronic studies in dogs resulted in increases in alkaline phosphatase levels as well as hepatic weights. In subchronic and chronic studies in rats, thyroid changes (including increases in weights and incidences of follicular cell hyperplasia and hypertrophy) were considered to have been the result of liver adaptive responses. Additionally, in three mechanistic rat studies, increases in liver microsomal activity, induction of total cytochrome P450 activity, and disruption of thyroid homeostasis (by decreasing circulating T3 and T4 and increasing TSH resulting from hepatic microsomal glucuronyltransferase) were noted. The liver and thyroid effects were reversed with the cessation of test article administration.

In the rabbit developmental toxicity study, abortions and early deliveries were observed in at the highest dose tested. Decreased pup body weights and/or body weight gains were noted in both the 2-generation reproductive toxicity study in rats and in the rat developmental neurotoxicity (DNT) study at a level that did not induce parental toxicity.

In two chronic/carcinogenicity studies in rats that were assessed together, statistically significant increases in thyroid follicular cell adenomas and significant differences in a pair-wise comparison with the controls were noted in males; thyroid hypertrophy and hyperplasia of follicular cells, as well as increased thyroid weights and mechanistic data were also noted. Female rats exhibited a slightly significant increase in thyroid follicular cell adenomas in these studies. A carcinogenicity study in mice showed no evidence of tumor formation in either sex, and no evidence of malignancies or mutagenicity was found in the toxicity database for boscalid. Based on the overall weak evidence of carcinogenic effects, EPA has classified boscalid as having suggestive evidence of carcinogenicity.

Specific information on the studies received and the nature of the adverse effects caused by boscalid 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: “Boscalid. Human Health Risk Assessment for Proposed Use on Alfalfa and Citrus (Crop Group 10), and for Proposed Increase in Tolerance on Stone Fruits (Crop Group 12).” Pages 41-44 in docket ID number EPA-HQ-OPP-2009-0268.

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

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

Additional information regarding the toxicological endpoints for boscalid used for human risk assessment can be found at http://www.regulations.gov in docket ID numbers EPA-HQ-OPP-2009-0268 and EPA-HQ-OPP-2005-0145.

1. Dietary exposure from food and feed uses . In evaluating dietary exposure to boscalid, EPA considered exposure under the petitioned-for tolerances as well as all existing boscalid tolerances in 40 CFR 180.589. EPA assessed dietary exposures from boscalid 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 boscalid; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure . In conducting the chronic dietary exposure assessment, EPA used the food consumption data from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA utilized tolerance-level residues and assumed 100 percent crop treated (PCT) data for all commodities.

iii. Cancer . As discussed in Unit III.A., EPA has classified boscalid as having suggestive evidence of carcinogenicity due to some evidence of thyroid follicular cell adenomas in male and female rats. Nonetheless, EPA concluded that the cPAD would be protective of these effects based on the following:

The adenomas occurred at dose levels above the level used to establish the cPAD, statistically significant increases were only seen for benign tumors (adenomas) and not for malignant ones (carcinomas), the increase in adenomas in females was slight, and there was no concern for mutagenicity. EPA's estimate of chronic exposure as described above is relied upon to evaluate whether any exposure could exceed the cPAD and thus pose a cancer risk.

iv. Anticipated residue and PCT information . EPA did not use anticipated residue or PCT information in the dietary assessment for boscalid. Tolerance level residues or 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water . The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for boscalid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of boscalid. 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 Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of boscalid for chronic exposures for non-cancer assessments are estimated to be 29.6 parts per billion (ppb) for surface water and 0.63 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 29.6 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).

Boscalid is currently registered for use on turf at golf courses and for use on several fruit commodities at “pick-your-own” (PYO) farms and orchards; therefore, post-application exposure to golfers and people harvesting fruit at PYO farms and orchards is possible. EPA assessed residential exposure using the following assumptions: For adult and adolescent (12 years of age or older) golfers, short-term post-application dermal exposure to turf treated with boscalid was assessed. PYO activities may result in potential acute post-application exposure to boscalid; however, because no adverse effects were noted in the boscalid toxicity database resulting from a single exposure to the chemical, a post-application exposure and risk assessment is not necessary for this scenario. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf .

EPA also notes that while adolescents are likely to represent the vast majority of youth who play golf on a routine basis, it is possible for younger children (less than 12 years old) to be exposed to golf course turf that has been treated with boscalid. However, assessing risk for younger golfers is difficult because of the uncertainties associated with the extrapolation of adult dermal exposure data and because of the increased likelihood of other behaviors that might contribute to exposure, such as incidental oral exposure resulting from contact with treated turf. Therefore, younger golfers were assessed qualitatively for this exposure scenario after selecting an appropriate target age of 5 years old to assess risk. The surface area to body weight ratio (SA/BW) for male children, when calculated and compared to that of the average adult, was found to be approximately 70% greater. Based on this parameter alone, the exposure to children could be almost twice that of the adult golfer; however, younger golfers are not expected to use the golf course for the same length of time as an adult. The shorter duration on the golf course for younger golfers offsets the higher SA/BW; therefore, risks from short-term post-application exposures to young golfers are likely to be similar to risks for adult golfers.

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

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

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

2. Prenatal and postnatal sensitivity . The prenatal and postnatal toxicology database for boscalid includes rat and rabbit prenatal developmental toxicity studies, a 2-generation reproductive toxicity study in rats, and a DNT study in rats. No qualitative or quantitative evidence of increased susceptibility was noted in the developmental toxicity study in rats. However, in the 2-generation reproduction study in rats, body weight effects were seen in the mid and high doses in the second generation male pups. However, the degree of concern is low for the quantitative evidence of susceptibility seen in this study, since the body weight effects were seen in only one sex and only after dosing for two generations. Also, there is a clear NOAEL for the body weight effects seen in the rat 2-generation reproduction study, and EPA is regulating based on a POD below where these effects were seen.

In the rat DNT study, transient body weight effects were seen in one sex at postnatal days 1-4 with the animals recovering by postnatal day 11. Body weight effects were also seen in the high dose, which was the limit dose. The degree of concern for these effects is low since the effects were either transient in nature or occurred at the limit dose, and EPA is regulating based on a POD below where these effects were seen. In the rabbit developmental study there was evidence of qualitative sensitivity; however, fetal effects were seen only at the limit dose in the presence of maternal toxicity. Further, since EPA is regulating based on a POD which is an order of magnitude below where these effects were seen in the rabbit developmental study, EPA concludes that there is a low degree of concern for the qualitative sensitivity evidenced in the fetuses in the rabbit developmental study.

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

i. The toxicity database for boscalid is complete, except for immunotoxicity testing. Recent changes to 40 CFR part 158 make immunotoxicity testing (OPPTS Guideline 870.7800) required for pesticide registration; however, the existing data are sufficient for endpoint selection for exposure/risk assessment scenarios, and for evaluation of the requirements under the FQPA. The available data for boscalid show no evidence of treatment-related effects on the immune system, and the Agency does not believe that conducting an immunotoxicity study will result in a lower point of departure than currently selected for overall risk assessment. Therefore, an additional database uncertainty factor to account for potential immunotoxicity does not need to be applied.

ii. A rat DNT study is available which provides no indication that boscalid is a neurotoxic chemical, and there is no evidence of reproductive or developmental neurotoxicity in the toxicity database.

iii. Data involving the testing of young animals did show increased quantitative sensitivity in the young with regard to body weight effects, and qualitative sensitivity was seen in one developmental study. However, clear NOAELs were identified for all of these effects. Moreover, the body weight effects at the LOAELs in these studies were either transient or inconsistent, and qualitative sensitivity occurred at the limit dose in the presence of maternal toxicity. Additionally, EPA is regulating based on a POD below where these effects are seen. EPA concludes that there are no residual uncertainties for prenatal and/or postnatal toxicity.

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. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to boscalid in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of adult golfers, which is expected to be similar to potential post-application exposure of children. These assessments will not underestimate the exposure and risks posed by boscalid.

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

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

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to boscalid from food and water will utilize 37% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of boscalid is not expected.

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

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in an aggregate MOE of 840 for the general U.S. population and an aggregate MOE of 1,140 for youth (13-19 years old). As described above, the level of risk to younger golfers is expected to be similar. Because EPA's level of concern for boscalid is a MOE of 100 or below, these MOEs are not of concern.

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

5. Aggregate cancer risk for U.S. population . Based on the discussion in Unit III.A., EPA has concluded that the cPAD is protective of possible cancer effects. Given the results of the chronic risk assessment above, cancer risk resulting from exposure to boscalid is not of concern.

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

Adequate gas chromatography with mass spectrometric detection (GC/MS) and GC with electron capture (EC) methods are available to enforce boscalid tolerances in or on plant and livestock commodities, respectively. The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

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

There are currently no Codex, Canadian, or Mexican MRLs for residues of boscalid in or on alfalfa forage, alfalfa hay, or citrus fruits. However, there is a Codex MRL for stone fruits at 3 ppm and a Canadian MRL for stone fruits at 1.7 ppm. At this time, the revised U.S. tolerance on fruit, stone, group 12 at 3.5 ppm cannot be harmonized because residue field trial data support a tolerance that is higher than the Codex and Canadian MRLs. Codex and Canadian MRLs for boscalid also exist for various livestock commodities. However, because Codex and Canadian MRLs on boscalid do not exist for some animal feed commodities which have U.S. tolerances, the dietary burden of boscalid is higher for animals in the U.S., and U.S. livestock tolerances cannot be harmonized with equivalent Codex or Canadian MRLs at this time.

Based on analysis of the data supporting the petition, EPA has revised the proposed tolerances on alfalfa, forage from 35 ppm to 30 ppm; alfalfa, hay from 85 ppm to 65 ppm; fruit, citrus, group 10 from 2.0 to 1.6 ppm; and fruit, stone, group 12 from 5.0 to 3.5 ppm. The Agency has also determined that individual tolerances are necessary for citrus, dried pulp at 4.5 ppm; and citrus, oil at 85 ppm because boscalid residues concentrate in these commodities. EPA revised these tolerance levels based on analysis of the residue field trial data using the Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial Data. Because tolerances are being established on alfalfa forage and alfalfa hay under 40 CFR 180.589(a)(1), which applies to residues resulting from intentional or inadvertent use, EPA has also revised current inadvertent residue tolerance entries so that they exclude alfalfa, as follows: animal feed, nongrass, group 18, forage, except alfalfa and animal feed, nongrass, group 18, hay, except alfalfa.

Additionally, EPA is modifying several tolerances for secondary residues in animal commodities. In conjunction with assessing potential residues in animal commodities from the proposed and established uses of boscalid, EPA has determined that the established tolerances for secondary residues in or on poultry and hog commodities need to be raised. Therefore, the Agency is increasing the established tolerances for hog, fat from 0.10 ppm to 0.20 ppm; poultry, fat from 0.05 ppm to 0.20 ppm; and poultry, meat byproducts from 0.10 to 0.20 ppm. Finally, EPA has revised the tolerance expression to clarify (1) that, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of boscalid not specifically mentioned; and (2) that compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression.

Therefore, tolerances are established for residues of boscalid, 3-pyridinecarboxamide, 2-chloro- N -(4′-chloro[1,1′-biphenyl]-2-yl), in or on alfalfa, forage at 30 ppm; alfalfa, hay at 65 ppm; fruit, citrus, group 10 at 1.6 ppm; citrus, dried pulp at 4.5 ppm; and citrus, oil at 85 ppm. Additionally, previously established tolerances are revised for fruit, stone, group 12 at 3.5 ppm; hog, fat at 0.20 ppm; poultry, fat at 0.20 ppm; and poultry, meat byproducts at 0.20 ppm. Finally, this regulation deletes a time-limited tolerance on tangerine at 2.0 ppm, as it expired on December 31, 2008.

This final rule establishes tolerances 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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This 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 ., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not 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).

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).

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).

i. Revising the introductory text for paragraphs (a)(1) and (a)(2);

ii. Revising the entry for “Fruit, stone, group 12” and alphabetically adding “Alfalfa, forage”; “Alfalfa, hay”; “Citrus, dried pulp”; “Citrus, oil”; and “Fruit, citrus, group 10”; to the table in paragraph (a)(1);

iii. Revising the entries for “Hog, fat”; “Poultry, fat”; and “Poultry, meat byproducts” in the table in paragraph (a)(2);

iv. Revising paragraph (b);

v. Revising paragraph (d) introductory text and revising the entries for “Animal feed, nongrass, group 18, forage” and “Animal feed, nongrass, group 18, hay” in the table in paragraph (d) to read as follows:

(a) General . (1) Tolerances are established for residues of the fungicide boscalid, including its metabolites and degradates, in or on the commodities listed below. Compliance with the tolerance levels specified below is to be determined by measuring only boscalid, 3-pyridinecarboxamide, 2-chloro- N -(4′-chloro[1,1'-biphenyl]-2-yl), in or on the following raw agricultural commodities:

(2) Tolerances are established for residues of the fungicide boscalid, including its metabolites and degradates, in or on the commodities listed below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of boscalid, 3-pyridinecarboxamide, 2-chloro- N -(4'-chloro[1,1'-biphenyl]-2-yl), and metabolites 2-chloro- N -(4'-chloro-5-hydroxy-biphenyl-2-yl) nicotinamide and glucuronic acid conjugate of 2-chloro- N -(4′-chloro-5-hydroxy-biphenyl-2-yl) nicotinamide, calculated as the stoichiometric equivalent of boscalid in or on the following food commodities:

(b) Section 18 emergency exemptions . Time-limited tolerances are established for residues of the fungicide boscalid, including its metabolites and degradates, in connection with use of the pesticide under section 18 emergency exemptions granted by EPA. Compliance with the tolerance level specified below is to be determined by measuring only boscalid, 3-pyridinecarboxamide, 2-chloro- N -(4′-chloro[1,1'-biphenyl]-2-yl). This tolerance will expire and is revoked on the date specified in the following table:

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 those engaged in the following activities:

• 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 to provide 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 .

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr . To access the harmonized test guidelines referenced in this document electronically, please go http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2009-0279 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before July 27, 2010. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing 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 this copy, identified by docket ID number EPA-HQ-OPP-2009-0279, 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 Facility'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 Facility telephone number is (703) 305-5805.

In the Federal Register of August 19, 2009 (74 FR 41898) (FRL-8426-7), 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 8F7485) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.626 be amended by establishing tolerances for residues of the fungicide prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thion, in or on grain, cereal, group 15, except sweet corn, sorghum and rice at 0.35 parts per million (ppm); forage, cereal, group 16, except sweet corn, sorghum and rice at 8.0 ppm; stover, cereal, group 16, except sweet corn, sorghum and rice at 10 ppm; hay, cereal, group 16, except sweet corn, sorghum and rice at 7.0 ppm; straw, cereal, group 16, except sweet corn, sorghum and rice at 5.0 ppm; corn, sweet, forage at 7.0 ppm; corn, sweet, stover at 8.0 ppm; and corn, sweet, kernel plus cob with husks removed at 0.02 ppm. That notice referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov . A comment was received on the notice of filing. EPA's response to the comment is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA has established and increased the proposed tolerance of 0.02 ppm for combined residues in/on sweet corn to a higher tolerance of 0.04 ppm. Further, EPA has modified crop group terminology and established tolerances for grain, cereal, group 15, except sweet corn, sorghum, and rice at 0.35 ppm; grain, cereal, group 16, except sorghum and rice; forage at 8.0 ppm; grain, cereal, group 16, except sorghum and rice; stover at 10 ppm; grain, cereal, group 16, except sorghum and rice; hay at 7.0 ppm; grain, cereal, group 16, except sorghum and rice; straw at 5.0 ppm. With the establishment of the above tolerances, EPA has revoked the following tolerances: barley, grain; barley, hay; barley, straw; wheat, forage; wheat, grain; wheat, hay; and wheat, straw. EPA is also not establishing the proposed tolerances for sweet corn forage at 7 ppm and sweet corn stover at 8 ppm because the commodities will be covered under grain, cereal, group 16; forage and stover. The reasons for these changes are explained in Unit IV.D.

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

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in 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 for prothioconazole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with prothioconazole 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. Prothioconazole has low acute toxicity by oral, dermal, and inhalation routes. It is not a dermal sensitizer, or a skin or eye irritant. Prothioconazole's metabolite, prothioconazole-desthio, also has low acute toxicity by oral, dermal, and inhalation routes. It is not a dermal sensitizer, or a skin irritant, but it is a slight eye irritant. The subchronic and chronic studies show that the target organs at the lowest observable adverse effects level (LOAEL) include the liver, kidney, urinary bladder, thyroid and blood. In addition, the chronic studies showed body weight and food consumption changes. Prothioconazole and its metabolites may be primary developmental toxicants, producing effects including malformations in the conceptus at levels equal to or below maternally toxic levels in some studies, particularly those studies conducted using prothioconazole-desthio. Reproduction studies in the rat with prothioconazole and prothioconazole-desthio suggest that these chemicals may not be primary reproductive toxicants. Acute and subchronic neurotoxicity studies were conducted in the rat using prothioconazole. A developmental neurotoxicity study was conducted in the rat using prothioconazole-desthio.

The available data show that the prothioconazole-desthio metabolite produces toxicity at lower dose levels in subchronic, developmental, reproductive, and neurotoxicity studies as compared with prothioconazole and the two additional metabolites that were tested.

The available carcinogenicity and/or chronic studies in the mouse and rat, using both prothioconazole and prothioconazole-desthio, show no increase in tumor incidence. Therefore, EPA has concluded that prothioconazole and its metabolites are not carcinogenic, and are classified as “Not likely to be Carcinogenic to Humans” according to the 2005 Cancer Guidelines.

Specific information on the studies received and the nature of the adverse effects caused by prothioconazole 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 “Prothioconazole. Human Health Risk Assessment for Proposed Section 3 Uses on Crop Group 15 and 16 (Cereal Grains and Forage, Fodder and Straw of the Cereal Grains Group Except Sweet Corn, Sorghum and Rice) and Sweet Corn,” pages 14 to 17 in docket ID number EPA-HQ-OPP-2009-0279.

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

A summary of the toxicological endpoints for prothioconazole used for human risk assessment is shown in the following Table.

1. Dietary exposure from food and feed uses . In evaluating dietary exposure to prothioconazole and its metabolites and/or degradates, EPA considered exposure under the petitioned-for tolerances as well as all existing prothioconazole tolerances in 40 CFR 180.626. EPA assessed dietary exposures from prothioconazole 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.

In estimating acute dietary exposure, EPA used food consumption information from the U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA conducted a moderately refined acute dietary exposure assessment. Average field trial values (because all of the crops included in this assessment are blended food forms, except sweet corn), empirical processing factors, and livestock maximum residues were incorporated into the refined acute assessment. The assessment also assumed 100% crop treated (CT). Since no observed effects would be attributable to a single dose exposure for the general U.S. population, females 13 to 49 years of age was the only population subgroup included in the acute assessment.

ii. Chronic exposure . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA conducted a moderately refined chronic dietary exposure assessment. Empirical processing factors, average field trial residues, and livestock commodity residues derived from feeding studies and a reasonably balanced dietary burden (RBDB) were incorporated into the chronic assessment; 100% crop treated was assumed.

iii. Cancer . EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight-of-the-evidence from cancer studies and other relevant data. Cancer risk is quantified using a linear or non-linear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or non-linear approach is used and a cancer RfD is calculated based on an earlier non-cancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized.

Based on the data summarized in Unit III.A., EPA has concluded that prothioconazole is classified as “Not Likely to be Carcinogenic to Humans.” Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information . Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by section 408(b)(2)(E) of FFDCA and authorized under section 408(f)(1) of FFDCA. Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances. Average residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water . The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for prothioconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of prothioconazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm .

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of prothioconazole for the acute dietary risk assessment, the water concentration value of 94.7 parts per billion (ppb) was used to assess the contribution to drinking water. For the chronic dietary risk assessment, the water concentration value of 84.3 ppb was used to assess the contribution to drinking water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.

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

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

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

Prothioconazole is a member of the triazole-containing class of pesticides, often referred to as the triazoles. EPA is not currently following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. The conazole pesticides, as a whole, tend to exhibit carcinogenic, developmental, reproductive, and/or neurological effects in mammals. Additionally, all the members of this class of compounds are capable of forming, via environmental and metabolic activities, 1,2,4-triazole, triazolylalanine and/or triazolylacetic acid. These metabolites have also been shown to cause developmental, reproductive, and/or neurological effects. That these compounds, however, have structural similarities and share some common effects does not alone show a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same sequence of major biochemical events. A number of potential events could contribute to the toxicity of conazoles (e.g., altered cholesterol levels, stress responses, altered DNA methylation). At this time, there is not sufficient evidence to determine whether conazoles share common mechanisms of toxicity. Without such understanding, there is no basis to make a common mechanism of toxicity finding for the diverse range of effects found. Investigations into the conazoles are currently being undertaken by the EPA's Office of Research and Development. When the results of this research are available, the Agency will make a determination of whether there is a common mechanism of toxicity and, therefore, a basis for assessing cumulative risk. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's website at http://www.epa.gov/pesticides/cumulative .

To support existing tolerances and to establish new tolerances for conazole pesticides, including prothioconazole, EPA conducted human health risk assessments for exposure to 1,2 4-triazole, triazolylalanine, and triazolylacetic acid resulting from the use of all current and pending uses of triazole-containing pesticides (as of 9/1/05). The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with the common metabolites (e.g., use of maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high-end estimates of both dietary and non-dietary exposures). Acute and chronic aggregate risk estimates associated with these compounds are below the Agency's level of concern for all durations of exposure and for all population subgroups, including those of infants and children. The Agency's risk assessment for these common metabolites is available in the propiconazole reregistration docket at http://www.regulations.gov , Docket ID Number EPA-HQ-OPP-2005-0497.

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

2. Prenatal and postnatal sensitivity . There is evidence of increased susceptibility following prenatal/or postnatal exposure in:

i. Rat developmental toxicity studies with prothioconazole as well as its prothioconazole-desthio and sulfonic acid K salt metabolites.

ii. Rabbit developmental toxicity studies with prothioconazole-desthio.

iii. A rat developmental neurotoxicity study with prothioconazole-desthio; and

iv. Multi-generation reproduction studies in the rat with prothioconazole-desthio. Effects include skeletal structural abnormalities, such as cleft palate, deviated snout, malocclusion, extra ribs, and developmental delays. Available data also show that the skeletal effects such as extra ribs are not completely reversible after birth in the rat, but persist as development continues.

Although increased susceptibility was seen in these studies, the Agency concluded that there is a low concern and no residual uncertainties for prenatal and/or postnatal toxicity effects of prothioconazole because:

• Developmental toxicity NOAELs and LOAELs from prenatal exposure are well characterized after oral and dermal exposure;

• The off-spring toxicity NOAELs and LOAELs from postnatal exposures are well characterized; and

• The NOAEL for the fetal effect, malformed vertebral body and ribs, is used for assessing acute risk of females 13 years and older and, because it is lower than the NOAELs in other developmental studies, is protective of all potential developmental effects.

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

i. The toxicity database for prothioconazole is considered complete, with the exception of required functional immunotoxicity testing. The Agency began requiring functional immunotoxicity testing of all food and non-food use pesticides on December 26, 2007. Although an immunotoxicity study in the mouse is part of the existing prothioconazole toxicity database, this study as reported does not satisfy the current guideline requirements for an immunotoxicity study (OPPTS 870.7800). As such, EPA is requiring that an immunotoxicity study be submitted which meets guideline requirements. EPA has evaluated the available prothioconazole toxicity database (including the non-guideline study in the mouse) to determine whether an additional database uncertainty factor is needed to account for potential immunotoxicity. In one chronic study in the rat (but not in the mouse or dog), blood leukocyte counts were significantly elevated at the high dose level (750 mg/kg/day) along with increased thrombocyte counts and decreased hemoglobin. However, this finding is made in the presence of toxicity to a broad range of organ systems such as the liver, urinary bladder, kidney, thyroid, and decreased body weight gains. In a chronic dog study, splenic effects (increased spleen weight with pigmentation and/or fibrosiderotic plaques) were seen at 40 mg/kg/day and above, but these effects are not considered to be indicative of immunotoxicity, and occurred in the presence of toxicity to the liver, kidney, thyroid, and decreased body weights. Furthermore, no signs of immunotoxicity, such as changes in leukocyte counts and albumin/globulin ratio, changes in thymus and spleen weights, or histopathological changes in lymphoid tissues, were observed at dose levels up to 400 mg/kg/day in the non-guideline immunotoxicity study in the mouse. There appears to be no basis for concern for immunotoxicity, particularly at the Points of Departure (POD) for prothioconazole and its metabolites which, at 2.0 and 1.1 mg/kg/day (Acute and Chronic Reference Dose (aRfD and cRfD), respectively) are two orders of magnitude lower than the 400 and 750 mg/kg/day dose levels mentioned in this Unit. This finding, along with the absence of immunotoxicity observed in the subchronic and chronic studies with prothioconazole and its metabolites supports the reduction of the FQPA factor to 1X in the interim, pending receipt of an acceptable guideline immunotoxicity study.

ii. There is an acceptable battery of neurotoxicity studies including a developmental neurotoxicity study. Although offspring neurotoxicity was found, characterized by peripheral nerve lesions in the developmental neurotoxicity studies on prothioconazole-desthio, the increase was seen only in the highest dose group at 105 mg/kg/day, was not considered treatment related, and a clear NOAEL was established for this study.

iii. Although increased susceptibility was seen in the developmental and reproduction studies, the Agency concluded that there is a low concern and no residual uncertainties for prenatal and/or postnatal toxicity effects of prothioconazole for the reasons explained in Unit III.D.2.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessment utilized empirical processing factors, 100% crop treated, average crop field trial residue levels, and livestock maximum residues. Results from ruminant feeding studies and poultry metabolism studies were used to determine the maximum residue levels for livestock commodities. The crop field trials were performed using maximum application rates and minimum pre-harvest intervals. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to prothioconazole in drinking water. These assessments will not underestimate the exposure and risks posed by prothioconazole.

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

Based on the proposed and existing crop uses for prothioconazole, dietary aggregate exposures (i.e., food plus drinking water) are anticipated. There are no residential uses for prothioconazole and, therefore, no residential exposures are anticipated. Consequently, only dietary (food plus drinking water) exposures were aggregated for this assessment.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to prothioconazole will occupy 38% of the aPAD for females 13 to 49 years of age, the population group receiving the greatest exposure.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to prothioconazole from food and water will utilize 21% of the cPAD for the general U.S. population and 62% of the cPAD for all infants <1 year old, the population group receiving the greatest exposure. There are no residential uses for prothioconazole.

3. Short-term risk . Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there is no residential exposure, prothioconazole is not expected to pose a short-term risk.

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

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

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

Adequate liquid chromatography methods with tandem mass spectrometry detection (LC/MS/MS) are available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

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

The Codex has established MRLs for residues of desthio-prothioconazole in barley at 0.2 ppm (04/2010), and in oats, rye, and wheat at 0.05 ppm each and in the fodder (dry) of cereal grains at 4 ppm and in the straw (dry) of cereal grains at 5 ppm. There are currently no established Mexican MRLs for prothioconazole. Canadian MRLs have been established for prothioconazole per se in/on several commodities, including barley (0.35 ppm), wheat (0.07 ppm), meat byproducts of cattle, goats, horses and sheep (0.2 ppm), meat byproducts of hogs (0.05 ppm), liver of poultry (0.02 ppm), meat of cattle, goats, horses, and sheep (0.02 ppm), and milk (0.02 ppm). Harmonization of the proposed tolerances with the existing Codex for prothioconazole is not possible at this time because of differences in tolerance expression and use patterns. The MRL expression for Codex is prothioconazole-desthio and is thus not compatible with the U.S. tolerance definition, the sum of prothiocoanzole and prothioconazole-desthio. Much of the Codex cereal grain supervised field trial data is from Europe, where the use pattern is different resulting in lower measured residues. The straw numerical value (5 ppm) is matched between the U.S. and Codex.

The tolerance definition for plant commodities in Canada were recently changed (02/10/2010) and is now harmonized with the U.S. residue definition. The barley tolerance of Canada agrees with the recommended U.S. tolerance for cereal grains (except sweet corn, sorghum, and rice) of 0.35 ppm. However, the Canadian tolerance for wheat is lower (0.07 ppm) than the recommended U.S. group tolerance. The 0.07 ppm value is the current U.S. tolerance value for wheat, but will be replaced by the cereal grain group tolerance. Canada does not routinely establish animal feed commodity tolerances, and therefore there are no harmonization issues with forage, stover, hay, and straw.

One comment was received from an anonymous source objecting to establishment of tolerances and stating that the Agency is not protecting human health. The response contained no scientific data or evidence to rebut the Agency's conclusion that there is a reasonable certainty that no harm will result from aggregate exposure to prothioconazole, including all anticipated dietary exposures and other exposures for which there is reliable information.

Prothioconazole tolerances for crop commodities listed in 40 CFR 180.626(a)(1) are expressed in terms of the combined residues of the fungicide prothioconazole and prothioconazole-desthio, calculated as parent. EPA has also revised the tolerance expression to clarify (1) that, as provided in section 408(a)(3) of FFDCA, the tolerance covers metabolites and degradates of prothioconazole not specifically mentioned; and (2) that compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression.

Tolerances are established for residues of prothioconazole, 2-[2-(1-chlorocylcopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thion, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only prothioconazole and its metabolite prothioconazole-desthio, or α-(1-chlorocyclopropyl)-α-[(2-chlorophenyl)methyl]-1H-1,2,4-triazole-1-ethanol, calculated as parent in or on the commodity.

Tolerances are established for residues of prothioconazole, 2-[2-(1-chlorocylcopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thion, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only prothioconazole and its metabolites prothioconazole-desthio, or α-(1-chlorocyclopropyl)-α-[(2-chlorophenyl)methyl]-1H-1,2,4-triazole-1-ethanol, and conjugates that can be converted to these two compounds by acid hydrolysis, calculated as parent in or on the commodity.

The proposed tolerance of 0.02 ppm for combined residues in/on sweet corn K+CWHR should be increased to 0.04 ppm (reflecting the combined limit of quantitation of 0.02 ppm each for prothioconazole and prothioconazole-desthio).

The proposed tolerances of 7 ppm for sweet corn forage and 8 ppm for sweet corn stover should be removed. These commodities will be covered by the tolerance for group 16 grain, cereal, forage and group 16, cereal, grain, stover, respectively.

With the establishment of the requested crop group tolerances for group 15 and 16, the established tolerances for the following commodities are no longer necessary and should be removed: barley, grain; barley, hay; barley, straw; wheat, forage; wheat, grain; wheat, hay; and wheat, straw.

Therefore, tolerances are established for residues of prothioconazole, 2-[2-(1-chlorocylcopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thion, including its metabolites and degradates, in or on grain, cereal, group 15, except sweet corn, sorghum, and rice at 0.35 ppm; grain, cereal, group 16, except sorghum and rice; forage at 8.0 ppm; grain, cereal, group 16, except sorghum and rice; stover at 10 ppm; grain, cereal, group 16, except sorghum and rice; hay at 7.0 ppm; grain, cereal, group 16, except sorghum and rice; straw at 5.0 ppm.; corn, sweet, kernel plus cob with husks removed at 0.04 ppm.

Further, the EPA is revoking the following eight existing tolerances because they are no longer needed as a result of this rule: barley, grain; barley, hay; barley, straw; wheat, forage; wheat, grain; wheat, hay; and wheat, straw. The EPA is also revising the prothioconazole crop and animal tolerance expressions.

This final rule establishes tolerances 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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This 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 ., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under 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.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not 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).

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).

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).

This document announces that, on November 23, 2009, OMB approved, for a period of three years, the information collection requirements contained in the Commission's Second Report and Order and in the Commission's rules at 47 CFR 64.605, FCC 08-275, published at 73 FR 79683, December 30, 2008. The OMB Control Number is 3060-1089. The Commission publishes this document as an announcement of the effective date of the revised rules. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 1-C823, 445 12th Street, SW, Washington, DC 20554. Please include the OMB Control Number, 3060-1089, in your correspondence. The Commission will also accept your comments via the Internet if you send them to PRA@fcc.gov and Cathy.Williams@fcc.gov.

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an e-mail to fcc504@fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

SYNOPSIS

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received OMB approval on November 23, 2009, for the information collection requirements contained in the Commission's Second Report and Order and the Commission's rules at 47 CFR 64.605. The OMB Control Number is 3060-1089. The total annual reporting burden for respondents for these collections of information, including the time for gathering and maintaining the collection of information, is estimated to be: 12 respondents, 5,608,692 responses, total annual burden hours of 206,061 hours, and $4,251,635 in total annual costs.

Under 5 CFR 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current valid OMB Control Number.

The foregoing document is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The Administrative Procedure Act (APA) (5 U.S.C. 553) specifically provides that notice and comment rulemaking procedures are not required where the Agency determines that there is good cause to dispense with them. Generally, good cause exists where the procedures are impracticable, unnecessary, or contrary to the public interest. 5 U.S.C. 553(b)(B). FMCSA proposes to use direct final rulemaking to streamline the rulemaking process where the rule is noncontroversial and the Agency does not expect adverse comment.

Direct final rulemaking will make more efficient use of FMCSA resources by reducing the time and resources necessary to develop, review, clear, and publish separate proposed and final rules for rules the Agency expects to be noncontroversial and unlikely to result in adverse public comment. A number of Federal agencies use this process, including various Department of Transportation operating administrations. For example, on January 30, 2004, the Office of the Secretary of Transportation published a final rule adopting direct final rule procedures (69 FR 4455) and the Federal Railroad Administration published a final rule adopting direct final rule procedures on March 7, 2007 (72 FR 10086).

FMCSA proposed direct final rulemaking procedures in an NPRM published on March 17, 2010, in the Federal Register (75 FR 12720). The NPRM described the process of how FMCSA will determine whether a particular rulemaking is noncontroversial and unlikely to result in adverse comments. The NPRM also described how FMCSA determines whether a comment is adverse or not.

FMCSA provided a 30-day comment period that ended on April 16, 2010. In response, the Agency received three comments and one question on the NPRM.

The Commercial Vehicle Safety Alliance, Advocates for Highway and Auto Safety (Advocates), and the American Trucking Associations submitted comments supporting the direct final rule procedures that were proposed in the NPRM. Advocates additionally stated that FMCSA should not use direct final rule procedures on safety-related rules, as these rules should be considered controversial and subject to full public notice and comment proceedings. They further maintain that FMCSA's granting of applications for waivers and two-year exemptions, under 49 U.S.C. 31315(a) and (b), and the renewal of such exemptions, should always be treated as controversial and subject to full public notice and comment procedures. As stated in the NPRM, FMCSA will use the direct final rule process for routine and noncontroversial rules. In the event that FMCSA publishes a direct final rule on an action that proves to be controversial, the public will have sufficient time and opportunity to submit adverse comments, or submit notices of intent to file adverse comments by the date specified in the direct final rule. If this occurs, FMCSA will publish a notice in the Federal Register withdrawing the direct final rule before it goes into effect.

Arkema Incorporated inquired about the number of days FMCSA is considering for a direct final rule to become effective after the date of publication in the Federal Register. As FMCSA intends to use the direct final rule process for routine and noncontroversial rules, the Agency will typically use 60 days after the date of publication in the Federal Register for the direct final rule to go into effect and 30 days after the date of publication in the Federal Register for the submission of adverse comments or notices of intent to submit adverse comments. FMCSA has the discretion to use a longer time period for a direct final rule to go into effect and a longer period for the submission of adverse comments if the Agency determines that it is necessary. If FMCSA receives adverse comments, or receives notice of intent to file adverse comments by the date specified in the direct final rule, it will publish a notice in the Federal Register withdrawing the direct final rule before it goes into effect.

FMCSA has determined that this action is not a significant regulatory action under Executive Order 12866 or under DOT's Regulatory Policies and Procedures. There are no costs associated with the final rule. There will be some cost savings in Federal Register publication costs and may be savings in efficiencies for the public and FMCSA personnel in eliminating duplicative reviews. I certify that this rule will not have a significant impact on a substantial number of small entities. Finally, FMCSA states that there are no Federalism implications.

This rulemaking contains no information collection requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

FMCSA has determined that the requirements of Title II of the Unfunded Mandates Act of 1995 do not apply to this final rule.

FMCSA considered the environmental impacts of this final rule under the National Environmental Policy Act of 1969, and determined it is categorically excluded from further environmental analysis under FMCSA Order 5610.1 paragraph 6.x of Appendix 2. FMCSA Order 5610.1 was published on March 1, 2004 (69 FR 9680). A Categorical Exclusion Determination is available for inspection or copying in the regulations.gov Web site listed under ADDRESSES .

Background

On October 27, 2003, we published a final rule in the Federal Register (68 FR 61123) to establish regulations for the issuance of permits to rehabilitate migratory birds in the United States. These regulations are at 50 CFR 21.31. Prior to issuance of the rehabilitation permit rule, migratory bird rehabilitators were required to obtain a special use permit to engage in rehabilitation activities. The last paragraph in the rehabilitation permit rule dealt with how we would handle issuing permits during the transition to the (then) new regulations. Since publication of that rule, all persons interested in having a permit to rehabilitate migratory birds must have transitioned from a special purpose permit to a rehabilitation permit. Because special purpose permits are valid for only 3 years, all of those permits in existence in 2003 have expired by now.

Therefore, the text in 50 CFR 21.31(i), “Will I need to apply for a new permit under this section if I already have a special purpose permit to rehabilitate birds, issued under § 21.27 (Special purpose permits)?” is no longer needed. With this final rule, our only change to the rehabilitation regulations is to remove all of the language under paragraph (i). This change is simply a ministerial administrative action to remove text that is no longer necessary from the Code of Federal Regulations and, therefore, will have no substantive effect on the general public.

In accordance with section 553 (b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 551 et seq. ), we are issuing this final rule without prior opportunity for public comment because public notice and comment procedures are unnecessary. We find that good cause exists to delete paragraph (i) of section 21.31 without going through the public-notice-and-comment procedure because the transition language is anachronistic and no public input received through an open comment period could justify retention of this paragraph. For the same reasons stated above, we find that there is good cause to have this final rule take effect immediately upon publication in the Federal Register (5 U.S.C. 553(d)(3).

The Office of Management and Budget (OMB) has determined that this rule is not significant under Executive Order 12866. OMB bases its determination upon the following four criteria:

a. Whether the rule will have an annual effect of $100 million or more on the economy or adversely affect an economic sector, productivity, jobs, the environment, or other units of the government.

b. Whether the rule will create inconsistencies with other Federal agencies' actions.

c. Whether the rule will materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients.

d. Whether the rule raises novel legal or policy issues.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 (Pub. L. 104-121)), whenever an agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities (that is, small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency certifies the rule will not have a significant economic impact on a substantial number of small entities.

SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide the statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. We have examined this rule's potential effects on small entities as required by the Regulatory Flexibility Act, and have determined that this action will not have a significant economic impact on a substantial number of small entities because the change in the regulation is simply to eliminate language that is no longer needed. Consequently, we certify that because this rule will not have a significant economic effect on any entity, let alone a substantial number of small entities, a regulatory flexibility analysis is not required.

This rule is not a major rule under the SBREFA (5 U.S.C. 804(2)). It will not have a significant economic impact on a substantial number of small entities.

a. This rule does not have an annual effect on the economy of $100 million or more. There are no costs to permittees or any other part of the economy associated with these regulation changes.

b. This rule will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. The practice of migratory bird rehabilitation does not significantly affect costs or prices in any sector of the economy.

c. This rule 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. Neither regulation nor practice of migratory bird rehabilitation significantly affects business activities.

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

a. This rule will not “significantly or uniquely” affect small governments. A small government agency plan is not required. Neither regulation nor practice of migratory bird rehabilitation affects small government activities.

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. No revisions of State, tribal, or territorial regulations will be necessary.

In accordance with E.O. 12630, the rule does not have significant takings implications. A takings implication assessment is not required. This rule does not contain a provision for taking of private property.

This rule does not have sufficient Federalism effects to warrant preparation of a Federalism assessment under E.O. 13132. It will not interfere with the States' abilities to manage themselves or their funds. No significant economic impacts are expected to result from the regulation of migratory bird rehabilitation.

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

We examined this rule under the Paperwork Reduction Act of 1995. OMB has approved the information collection requirements of the Migratory Bird Permits Program and assigned OMB control number 1018-0022, which expires November 30, 2010. This rule does not change the approved information collection. Information from the collection is used to ensure that rehabilitation permit applicants are qualified and that their activities are documented. A Federal agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

We evaluated the environmental impacts of the change to the regulations, and determined that, within the spirit and intent of the Council on Environmental Quality's regulations for implementing the National Environmental Policy Act (NEPA), and other statutes, orders, and policies that protect fish and wildlife resources, the regulatory change does not have a significant effect on the human environment. Under the guidance in Appendix 1 of the Department of the Interior Manual at 516 DM 8, we conclude that the regulatory change is categorically excluded because it has “no or minor potential environmental impact” (516 DM 8.5(A)(1)). No more comprehensive NEPA analysis of the regulations change is required.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175, and 512 DM 2, we have evaluated potential effects on Federally recognized Indian Tribes and have determined that this rule will not interfere with tribes' ability to manage themselves or their funds or to regulate migratory bird rehabilitation on tribal lands.

E.O. 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. Because this rule only affects the practice of migratory bird rehabilitation in the United States, it is not a significant regulatory action under E.O. 12866, and will not significantly affect energy supplies, distribution, or use. No Statement of Energy Effects is required.

This action has no environmental or socioeconomic impacts.

Section 7 of the Endangered Species Act (ESA) of 1973, as amended (16 U.S.C. 1531 et seq. ), requires that “The Secretary [of the Interior] shall review other programs administered by him and utilize such programs in furtherance of the purposes of this chapter” (16 U.S.C. 1536(a)(1)). It further states that the Secretary must “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” (16 U.S.C. 1536(a)(2)). This regulatory change will not affect threatened or endangered species or their habitats in the United States.