The Federal Retirement Thrift Investment Board (Agency) administers the Thrift Savings Plan (TSP), which was established by the Federal Employees' Retirement System Act of 1986 (FERSA), Public Law 99-335, 100 Stat. 514. The TSP provisions of FERSA are codified, as amended, largely at 5 U.S.C. 8351 and 8401-79. The TSP is a defined-contribution retirement savings plan for Federal civilian employees and members of the uniformed services. The TSP is similar to a private-sector “401(k) plan,”i.e.,a cash or deferred arrangement described in section 401(k) of the Internal Revenue Code (26 U.S.C. 401(k)).

The Thrift Savings Plan Enhancement Act of 2009, Public Law 111-31, Division B, Title I, authorized the Agency to implement a qualified Roth contribution program described in section 402A of the Internal Revenue Code. This feature will allow participants to make TSP contributions on an after-tax basis and receive tax-free earnings upon distribution if (1) five years have passed since January 1 of the year in which they made their first Roth contribution, and (2) a qualifying event has occurred (i.e.,attainment of age 591/2permanent disability, or death). The TSP Roth feature is similar to a designated Roth account maintained by a 401(k) plan.

On February 8, 2012, the Agency published a proposed rule with request for comments in theFederal Register(77 FR 6504, February 8, 2012). The Agency received one or more comments from five individuals.

One individual commented that requiring distributions to be made pro rata from participants' Roth and traditional balances is disadvantageous to participants who wish to withdraw a portion of their account balance within five years after having made their first Roth contribution. The Agency is aware that this rule will have tax consequences for participants who wish to withdraw a portion of their account balance within five years after having made their first Roth contribution. The Agency also understands that this rule is unique to the TSP.

The Agency adopted this rule to facilitate the availability of Roth contributions as early as possible. To allow participants to designate the source of their distributions would require significant modifications to Optical Character Recognition (OCR) forms and system applications which would delay the availability of Roth contributions. The Agency intends to revisit this rule in three to five years.

Two individuals objected to the pro rata distribution of Roth contributions and earnings. The allocation of Roth contributions and earnings to a distribution from a Roth TSP balance is dictated by the Internal Revenue Code. A distribution from a Roth TSP balance is treated differently under the Internal Revenue Code than a distribution from a Roth IRA. Roth IRAs are governed by section 408A of the Internal Revenue Code, whereas the Roth TSP feature is governed by section 402A of the Internal Revenue Code. The ordering rules in section 408A(d)(4),which provide that the first distributions from a Roth IRA are a nontaxable return of contributions until all contributions have been returned, do not apply to distributions from a TSP Roth balance. Instead, the Agency is required treat distributions from a Roth balance as consisting proportionately of contributions and proportionately of earnings.See26 CFR 1.402A-1, Q&A-3.

One individual suggested that Roth TSP balances should not be subject to the required minimum distribution rules provided in section 401(a)(9) of the Internal Revenue Code. Pursuant to guidance issued by the Internal Revenue Service, the Agency must apply the required minimum distribution rules with respect to a participant's Roth TSP balance in the same manner as any other portion of the participant's account balance.See26 CFR 1.401(k)-1(f)(4).

Two individuals suggested that the TSP permit in-plan Roth rollovers. The Small Business Jobs Act of 2010, Public Law 111-240, allowed employer-sponsored plans to offer “in-plan Roth rollovers.” An in-plan Roth rollover in the context of the TSP would be a transfer or rollover of funds from a participant's traditional balance to the participant's Roth balance.1 However, the Small Business Jobs Act of 2010 was not effective until September 27, 2010, well after the TSP began its work to implement the Roth feature. In addition, the Internal Revenue Code places significant limitations on in-plan Roth rollovers. For example, the Agency cannot permit a participant to transfer or rollover non-Roth TSP funds to a Roth TSP balance unless that participant is eligible to make an existing withdrawal election. Therefore, a TSP participant who is still employed by the Federal government could elect an in-plan Roth rollover only if he/she has attained age 591/2. The Agency does not have the authority to expand its withdrawal elections without seeking an amendment to its governing statute. For these reasons, the Agency has decided to postpone any formal consideration of offering in-plan Roth rollovers until after the TSP Roth contribution feature is fully implemented.

The Thrift Savings Plan will begin accepting Roth contributions from Federal agency and uniformed service payroll offices on May 7, 2012.However, not all agencies or services have completed the technical and programmatic modifications of their payroll systems required to implement Roth TSP. These agencies or services will require additional time to modify their payroll systems and will permit their employees to make Roth contributions as soon after May 7, 2012 as they are able.

The TSP offers the following four types of accounts: Civilian accounts, uniformed services accounts, civilian beneficiary participant accounts, and uniformed services beneficiary participant accounts. A participant's Roth contributions and associated earnings may be one balance among several balances maintained in one or more of these four types of accounts. The Agency has adopted new terminology by which to refer to each of these balances.

Within each of these four types of accounts, the Agency may maintain a “Roth balance.” A Roth balance consists of (1) Roth contributions and associated earnings and (2) Roth money transferred into the TSP and associated earnings. No other contributions (e.g.matching or Agency Automatic (1%) Contributions) will be allocated to the participant's Roth balance. The Agency will separately account for all Roth balance contributions, gains, and losses in order to determine the taxable and nontaxable portions of a distribution from a participant's account.

Within each of these four types of accounts, the Agency may also maintain a “traditional balance.” A traditional balance consists of (1) Tax-deferred employee contributions and associated earnings; (2) tax-deferred amounts rolled over or transferred into the TSP and associated earnings; (3) tax-exempt contributions and associated earnings; (4) matching contributions and associated earnings; and (5) Agency Automatic (1%) Contributions and associated earnings.

Within a traditional balance, the Agency may maintain a “tax-deferred balance” and a “tax-exempt balance.” A tax-deferred balance consists of all amounts in a participant's traditional balance that would otherwise be includible in gross income if paid directly to the participant. A tax-exempt balance consists only of tax-exempt contributions made to a participant's traditional balance. Earnings on tax-exempt contributions will be included in the participant's tax-deferred balance. Because a tax-exempt balance includes only tax-exempt contributions, the terms “tax-exempt balance” and “tax-exempt contributions” are interchangeable.

Tax-exempt contributions are employee contributions made to a uniformed services participant's traditional balance from pay which is exempt from taxation under 26 U.S.C. 112 because it was earned in a combat zone. Consequently, only a traditional balance that is in a uniformed services account or a uniformed services beneficiary participant account may contain tax-exempt contributions.

The term “tax-exempt contributions” does not include contributions made to the participant's Roth balance from pay which is exempt from taxation under 26 U.S.C. 112. Whether a Roth contribution is made from taxable pay or tax-exempt pay, the Agency will maintain all Roth contributions in a participant's Roth balance.

After the effective date of this rule, any reference in the Agency's regulations to a participant's “account balance” will mean the aggregate of the participant's traditional balance and the participant's Roth balance.

Section 1600.11 currently permits the following types of contribution elections: (1) To make employee contributions; (2) to change the amount of employee contributions; and (3) to terminate employee contributions. The Agency is amending § 1600.11 to add an election to change thetypeof employee contributions.

This final rule also adds a new section, 1600.20, to describe the types of employee contributions that a participant may make. Section 1600.20 permits employees to make traditional contributions, Roth contributions, or a combination of both. Paragraph (c) of § 1600.20 ensures that a uniformed services participant's tax-exempt pay will be contributed to his or her traditional or Roth balance (or a combination of both) in accordance with the contribution election made under § 1600.11.

Section 1690.1 contains definitions generally applicable to the TSP. This final rule adds definitions for the terms “employee contributions,” “traditional contributions,” and “Roth contributions.” Employee contributions are traditional contributions and Roth contributions made at the participant's election pursuant to § 1600.12 and deducted from compensation paid to the participant.2

Traditional contributions are tax-deferred employee contributions and tax-exempt employee contributions made to the participant's traditional balance. Roth contributions are employee contributions made to the participant's Roth balance. A participant's employing agency will deduct Roth contributions from taxable pay on an after-tax basis or from pay exempt from taxation under 26 U.S.C. 112.

Section 1600.22 currently provides that contributions, other than catch-up contributions, made at the participant's election are subject to the elective deferral limit contained in section 402(g) of the Internal Revenue Code. Like tax-deferred employee contributions, Roth contributions are subject to the Internal Revenue Code's elective deferral limit.See26 U.S.C. 402A(c)(2); 26 CFR 1.402(g)-1(b)(5).

The Agency is revising § 1600.22 to provide that tax-deferred contributions and Roth contributions, but not tax-exempt contributions to a participant's traditional balance, are subject to the Internal Revenue Code's elective deferral limit. Elective deferrals are, by definition, tax-deferred contributions unless they are Roth contributions.See26 CFR 1.402(g)-1(a). Tax-exempt contributions to a participant's traditional balance are neither tax-deferred contributions nor Roth contributions. These tax-exempt contributions are treated as basis for tax purposes and the Agency does not track them against the maximum elective deferral limit set forth in 26 U.S.C. 402(g).

A participant may make traditional contributions and Roth contributions during the same year, but the combined total of tax-deferred employee contributions and Roth contributions cannot exceed the Internal Revenue Code's elective deferral limit. Likewise, a participant may make employee contributions to both a civilian account and a uniformed services account during the same year, but the combined total of tax-deferred employee contributions and Roth contributions to both accounts cannot exceed the Internal Revenue Code's elective deferral limit.

This final rule also removes all references to the percentage limitation on contributions that existed prior to 2006. Those references are obsolete. The Consolidated Appropriations Act for Fiscal Year 2001, Public Law 106-554, changed the limits on FERS and CSRS TSP employee contributions by raising the percentage limitation by one percenteach year until 2006, when the limits were removed altogether. The maximum TSP employee contribution is now limited only by the provisions of the Internal Revenue Code.

This final rule relocates the catch-up contribution rules from paragraph (b) of § 1600.22 to a new section numbered 1600.23.

FERSA provides that an eligible participant (as defined by section 414(v) of the Internal Revenue Code) may make catch-up contributions to the Thrift Savings Fund to the extent permitted by section 414(v) and Agency regulations. 5 U.S.C. 8432(a)(3). The Internal Revenue Code permits eligible participants to make Roth catch-up contributions. The Agency will therefore allow eligible participants to designate catch-up contributions as Roth catch-up contributions.

Under section 414(v) of the Internal Revenue Code, catch-up contributions must be elective deferrals. For reasons explained above, the Agency does not treat tax-exempt contributions to a traditional balance as elective deferrals. Therefore, members of the uniformed services are not permitted to make catch-up contributions to a traditional balance from tax-exempt pay. However, members of the uniformed services may make catch-up contributions to a Roth balance from tax-exempt pay. All catch-up contributions are subject to the limit described in section 414(v) of the Internal Revenue Code.

A participant may make traditional catch-up contributions and Roth catch-up contributions during the same year, but the combined total amount of catch-up contributions of both types cannot exceed the Internal Revenue Code's catch-up contribution limit. Likewise, a participant who has both a civilian account and a uniformed services account may make catch-up contributions to both accounts during the same year, but the combined total amount of catch-up contributions to both accounts cannot exceed the Internal Revenue Code's catch-up contribution limit.

This final rule adds a new section, 1600.19, to address rules and procedures related to employing agency contributions. Section 1600.19 provides that a participant's eligibility to receive matching contributions is the same whether the participant chooses to make traditional contributions, Roth contributions, or a combination of both. Section 1600.19 also provides that the Agency will allocate all employing agency contributions to the tax-deferred balance within a participant's traditional balance.

For example, suppose a FERS participant elects to contribute 1% of his or her basic pay as a traditional contribution and 2% of his or her basic pay as a Roth contribution. The employing agency must contribute 3% of that employee's basic pay to the employee's tax-deferred balance as a matching contribution. Because the employee is a FERS participant, the employing agency must also contribute Agency Automatic (1%) Contributions to the employee's tax-deferred balance whether or not he or she continues to make employee contributions.

The Agency is amending § 1690.1 to add a definition for the term “trustee-to-trustee transfer” (or “transfer”). A trustee-to-trustee transfer is a payment of an eligible rollover distribution directly from one eligible employer plan, traditional IRA, or Roth IRA to another eligible employer plan, traditional IRA, or Roth IRA at the participant's request.3

Section 1600.32 provides two methods for transferring an eligible rollover distribution into the TSP: (1) Trustee-to-trustee transfer (i.e.,direct rollover), and (2) rollover by the participant within 60 days of receipt. The Agency is revising § 1600.32 by redesignating it as § 1600.31 and by providing the conditions under which the Agency will accept a transfer consisting of Roth money.

Specifically, the Agency must receive (1) a statement from the plan administrator indicating the first year of the participant's 5 year Roth non-exclusion period (as defined by 26 U.S.C. 402A(d)(2)(B)) under the distributing plan, and (2)eitherthe portion of the transfer amount that represents Roth contributions (i.e.,tax basis) or a statement that the entire amount of the transfer is a qualified Roth distribution (as defined by 26 U.S.C. 402A(d)(2)(A)). This requirement is necessary to enable the TSP to determine whether the earnings portion of any subsequent distribution from the participant's Roth balance may be received tax-free.

The Agency is also revising § 1600.32 to provide that the TSP will not accept Roth money that is rolled over by a participant after the participant has received the distribution. A rollover by the participant in lieu of a transfer would result in several disadvantages to the participant. First, when a participant does a rollover after he or she receives a distribution of Roth money in lieu of doing a transfer, the first taxable year in which the participant made a Roth contribution to the distributing plan does not carry over to the TSP for purposes of determining whether the earnings portion of a subsequent distribution from the participant's Roth balance may be received tax-free.See26 CFR 1.402A-1, Q&A-5(c). Second, the Internal Revenue Service prohibits participants from rolling over any nontaxable portion of a distribution from a designated Roth account (i.e.,a Roth 401(k), Roth 403(b), or Roth 457(b) account) after the participant has received the distribution.See26 CFR 1.402A-1, Q&A-5(a). For these reasons, the TSP will accept Roth money only if the TSP receives the money via trustee-to-trustee transfer (i.e.,direct rollover).

FERSA provides that the maximum amount permitted to be transferred to the Thrift Savings Fund shall not exceed the amount which would otherwise have been included in the participant's gross income for Federal income tax purposes.See5 U.S.C. 8432(j)(2). In accordance with FERSA, § 1600.31 prohibits the transfer of after-tax or tax-exempt money into the TSP. This final rule redesignates § 1600.31 as § 1600.30 and revises paragraph (c)(1)(vi) of redesignated § 1600.30 to clarify that FERSA's prohibition against transferring after-tax money or tax-exempt money into the TSP does not apply to Roth money. Although FERSA's prohibition against transferring after-tax money or tax-exempt money into the TSP does not apply to Roth money, the Internal Revenue Code prohibits the transfer of Roth money from a Roth IRA to the TSP Roth balance. Therefore, the TSP will only accept Roth money if it is transferred from a designated Roth account (i.e.,a Roth 401(k) account, Roth 403(b) account, or Roth 457(b) account).

In summary, the Agency will not accept a rollover of Roth money distributed from any plan or IRA after the participant has received the money. The Agency cannot accept Roth money that is transferred from a Roth IRA. The Agency will, however, accept Roth money that is transferred from a designated Roth account (i.e.,a Roth 401(k) account, Roth 403(b) account, or Roth 457(b) account).

Section 1600.34 currently provides that all newly hired Federal employees eligible to participate in the TSP (andFederal employees rehired after a separation in service of 31 or more calendar days and eligible to participate in the TSP) will automatically have 3% of their basic pay contributed to the TSP. These default employee contributions will be made unless the employee elects not to contribute or to contribute at some other level before the end of the employee's first pay period. The introduction of Roth contributions makes it necessary to establish whether default employee contributions are traditional contributions or Roth contributions. Accordingly, the Agency is amending § 1600.34 to provide that all default employee contributions shall be contributed to the employee's traditional balance.

Section 1600.34 also currently provides that an employee can opt out of automatic enrollment and/or terminate default employee contributions by submitting a contribution election. Under newly revised § 1600.11, a contribution election includes an election to change, add, or terminate any type of contribution. For consistency, the Agency is amending § 1600.34 to provide that an employee can opt out of automatic enrollment and/or terminate default employee contributions by submitting an election to make Roth contributions. A participant can opt out of automatic enrollment or terminate default employee contributions by submitting an election to make Roth contributions even if the election does not result in a change to the employee's total contribution percentage or amount (e.g.,a participant elects to contribute 3% of his or her basic pay as Roth contributions and thus terminates all traditional contributions).

This final rule removes Part 1604 of the Agency's regulations. Part 1604 currently contains rules that are uniquely applicable to uniformed services accounts. However, Part 1604 also contains some redundant rules and some rules not uniquely applicable to uniformed services accounts. In addition, the Agency's regulations have evolved such that other parts also contain rules that are uniquely applicable to uniformed services accounts. For this reason, the Agency is eliminating Part 1604 by deleting redundant provisions and relocating the remaining provisions as follows:

This final rule adds definitions to § 1605.1 for the terms “recharacterization” and “redesignation.” Recharacterization is the process of changing a contribution erroneously submitted by an employing agency as a tax-deferred contribution to a tax-exempt contribution or vice versa. Redesignation is the process of changing a contribution erroneously submitted by an employing agency as a traditional contribution to a Roth contribution or vice versa. The rule also sets forth the rules and procedures for redesignation and recharacterization in a new section numbered 1605.17.

The term “recharacterization” is not synonymous with that term as it is used in regulations or guidance published by the Internal Revenue Service.4 The Agency uses “recharacterization” and “redesignation” to refer to methods of error correction only. That is, a TSP contribution cannot be recharacterized or redesignated at the participant's request. Once a contribution has been made to the participant's account, it cannot be recharacterized or redesignated unless the employing agency erred in its submission. Therefore, a participant cannot elect to retroactively change the tax characteristics of contributions that have already been made.See26 CFR 1.401(k)-1(f)(i).

The Agency is revising § 1605.12 to provide that positive earnings on an erroneous contribution to a participant's Roth balance will be moved to the participant's traditional balance when the error is corrected. If the Agency were to permit earnings attributable to an erroneous contribution to remain in the Roth balance when the contribution should have been to the participant's traditional balance, the Agency would arguably permit a transfer of value from the participant's traditional balance to the participant's Roth balance. The Internal Revenue Service prohibits any transaction or accounting method involving a participant's Roth balance and any other balance that has the effect of directly or indirectly transferring value from the other balance into the Roth balance.See26 CFR 1.402A-1, Q&A-13.

The Agency is amending paragraph (c)(1) of § 1605.11 to provide that the schedule of makeup contributions elected by the participant must establish the type of contribution (i.e.,traditional, Roth, or both) to be made each pay period over the duration of the schedule. The Agency is also adding paragraph (c)(12) to 1605.11 in order to provide that a participant cannot contribute a makeup contribution with an “as of” date occurring prior to May 5, 2012 to his or her Roth balance. If the “as of” date of a late or makeup Roth contribution is earlier than the existing date of a participant's first Roth contribution, the Agency will adjust the start date of the participant's 5-year non-exclusion period (as defined by 26 U.S.C. 402A(d)(2)(B) accordingly.

The Agency is revising §§ 1650.2, 1650.23, 1651.14, 1653.3, and 1653.5 to add Roth IRAs to the types of retirement savings vehicles to which a participant, beneficiary, or alternate payee might choose to transfer or roll over a TSP distribution. This final rule also adds a new section, 1650.25, to address rules and procedures pertaining to transfers from the TSP.

Section 1650.25 permits a participant to elect to transfer an eligible rollover distribution consisting of funds from his or her traditional balance to a single eligible employer plan or IRA and funds from his or her Roth balance to another eligible employer plan or IRA. The Agency will also allow a participant to elect to transfer the traditional and Roth portions of a payment to the same plan or IRA but, for each type of balance, the election must be made separately and each type of balance will be transferredseparately. The Agency will not transfer portions of a participant's traditional balance to two different eligible employer plans and/or IRAs or portions of a participant's Roth balance to two different eligible employer plans and/or IRAs.

Paragraph (c) of § 1650.25 requires the TSP to inform the plan administrator or trustee of the plan or Roth IRA receiving a distribution from a Roth TSP balance of (1) the start date of the participant's Roth 5 year non-exclusion period or the date of the participant's first Roth contribution, and (2) the portion of the distribution that represents Roth contributions. If a participant elects not to transfer a distribution from his or her Roth balance, the Agency will inform the participant of the amount of the distribution that represents Roth contributions.

Paragraph (e) of § 1650.25 clarifies that a participant may transfer a distribution from the TSP to another eligible employer plan or to an IRA only to the extent the transfer is permitted by the Internal Revenue Code.

The Agency is amending its regulations to provide that all withdrawals, loan distributions, death benefit distributions, court-ordered payments, and required minimum distributions will be disbursed pro rata from a participant's traditional and Roth balance.

The Agency is also amending its regulations to require distributions from a traditional balance to be pro rated between the tax-deferred balance and tax-exempt contributions (if any) and to require distributions from a Roth balance to be pro rated between contributions in the Roth balance and earnings in the Roth balance. This requirement is necessary because Internal Revenue Code section 72 precludes the TSP from allocating the portion of an account balance that has already been taxed to a distribution in a manner that is other than pro rata.

The Internal Revenue Service prohibits any transaction involving a participant's Roth balance and any other balances that would have the effect of directly or indirectly transferring value from the other balance(s) into the Roth balance. 26 CFR 1.402A-1, Q&A-13. The Internal Revenue Service has noted that it may be difficult for a single annuity contract to have guarantees that apply to both Roth and non-Roth balances without the potential for a prohibited transfer of value between the balances.See72 FR 21107 (third column). Accordingly, the Agency is amending § 1650.14 to prohibit the purchase of one annuity contract with both the traditional portion and the Roth portion of a withdrawal. If a participant who has a Roth balance and a traditional balance desires to purchase an annuity, he or she must purchase two separate contracts; one with the traditional balance and one with the Roth balance.

Section 1650.14 currently requires a minimum amount of $3,500 to purchase an annuity. The Agency is amending § 1650.14 to provide that the $3,500 minimum threshold applies to each annuity purchased. If a participant who has a Roth balance elects to use 100% of a withdrawal to purchase life annuities and both the traditional balance and the Roth balance are below $3,500, the TSP will reject the participant's withdrawal request. If only one balance is below $3,500, then the TSP will pay that balance to the participant in a single payment and use the balance that is $3,500 or above to purchase an annuity.

If a participant who has a Roth balance makes a mixed withdrawal election and both the traditional balance and the Roth balance are below $3,500, the TSP will reject the withdrawal request. If only one balance is below $3,500, then the TSP will pro rate that balance among the participant's other elected withdrawal options and will use the balance that is $3,500 or above to purchase an annuity.

Section 1650.14 currently allows a participant to select from several types of annuities: (1) Single life, (2) joint life of the participant and spouse, and (3) joint life of the participant and a person with an insurable interest in the participant. The Agency is amending § 1650.14 to provide that, if a participant is required to purchase two separate annuities, the participant's withdrawal election among the types of annuities and any available options and features, will apply to both annuities purchased. A participant cannot elect more than one type of annuity per account.

The Agency is amending § 1651.3 to provide that a beneficiary designation form is not valid if it attempts to designate beneficiaries for the participant's traditional balance and the participant's Roth balance separately. The Agency is also amending § 1651.17 to provide that a valid disclaimer cannot specify which balance shall be disclaimed.

A TSP participant's account balance cannot be assigned or alienated and is not subject to execution, levy, attachment, garnishment, or other legal process except as provided for in 5 U.S.C. 8437(e)(3). Section 8437(e)(3) provides that a participant's account balance shall be subject to an obligation of the Executive Director to make a payment to another person under a domestic relations court order described in section 8467.

A domestic relations court order is enforceable against the TSP only if it is a “qualifying retirement benefits court order” or “qualifying legal process” as defined by 5 CFR part 1653. A retirement benefits court order or legal process is qualifying only if it satisfies the requirements and conditions set forth in 5 CFR 1653.2 or 5 CFR 1653.12, respectively. The Agency is amending §§ 1653.2 and 1653.12 to provide that a retirement benefits court order or legal process is not qualifying if it purports to designate the TSP Fund, source of contributions, or balance (e.g.traditional, Roth, or tax-exempt) from which the payment or portions of the payment shall be made.

The Agency is amending § 1655.9 to provide that the TSP will credit loan payments to a participant's traditional and Roth balances in the same proportion that the loan was distributed from the participant's account. This requirement is necessary to ensure that the loan repayment requirements under Internal Revenue Code section 72(p)(2)(C) (i.e.,at least quarterly amortization of principal and interest) are satisfied separately with respect to the Roth balance.

I certify that this regulation will not have a significant economic impact on a substantial number of small entities. This regulation will affect Federal employees and members of the uniformed services who participate in the Thrift Savings Plan, which is a Federal defined contribution retirement savings plan created under the Federal Employees' Retirement System Act of 1986 (FERSA), Public Law 99-335, 100 Stat. 514, and which is administered by the Agency.

I certify that these regulations do not require additional reporting under the criteria of the Paperwork Reduction Act.

Pursuant to the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 602, 632, 653, 1501-1571, the effects of this regulation on state, local, and tribal governments and the private sector have been assessed. This regulation will not compel the expenditure in any one year of $100 million or more by state, local, and tribal governments, in the aggregate, or by the private sector. Therefore, a statement under § 1532 is not required.

Pursuant to 5 U.S.C. 810(a)(1)(A), the Agency submitted 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 before publication of this rule in theFederal Register.This rule is not a major rule as defined at 5 U.S.C. 814(2).

For the reasons stated in the preamble, the Agency amends 5 CFR chapter VI as follows:

In the first stage of its eFiling initiative, the FLRA enabled parties to use eFiling to file requests for Federal Service Impasses Panel assistance in the resolution of negotiation impasses.See77 FR 5987 (Feb. 7, 2012).

This final rule accompanies the second of three stages of the FLRA's eFiling initiative. In this stage, parties will be able to use the FLRA's eFiling system to electronically file 11 types of documents in cases that are filed with the FLRA's three-Member adjudicatory body, the Authority. This rule modifies the FLRA's existing regulations to allow for eFiling of such documents, clarifies some of the FLRA's procedural regulations, and explains how to calculate the due date for filing when parties are served with documents by more than one method. In addition, the rule provides that parties may use electronic mail (“email”) to serve one another, but only if the served party agrees to email service. Further, it modifies 5 CFR 2423.40(a)(3) to conform to 5 CFR 2429.29, and deletes the statement in 5 CFR 2429.24 that provides for parties filing carbon copies of typewritten material.

As the FLRA's eFiling procedures develop, the revisions set forth in this action may be evaluated and revised further.

Sectional analyses of the amendments and revisions to part 2423, Unfair Labor Practice Proceedings, part 2424, Negotiability Proceedings, part 2425, Review of Arbitration Awards, and part 2429, Miscellaneous and General Requirements, are as follows:

This section is amended to state that part 2423 is applicable to any unfair labor practice cases that are pending or filed with the FLRA on or after June 4, 2012.

This section is amended to state that a charging party in an unfair labor practice case may serve the charge on the charged party by email, but only if the charged party has agreed to email service.

Paragraph (a)(3) of this section, which requires a table of contents and table of authorities for exceptions containing 25 or more pages, is amended to eliminate the reference to a table of contents. While a table of contents is still required under 5 CFR 2429.29, the table of contents requirement in this section is inconsistent with 5 CFR 2429.29, which requires a table of contents for documents exceeding 10 double-spaced pages.

This section is amended to state that part 2424 is applicable to all petitions for review filed on or after June 4, 2012.

Paragraph (b) of this section is amended to state that a petition for review filed electronically through use of the FLRA's eFiling system satisfies the content requirements of this paragraph, and that a petition need not be dated if it is eFiled. Paragraph (b) also is amended to state that copies of petition forms are available on the FLRA's Web site. Finally, paragraph (b)(2) is amended to state that documents submitted along with a petition may be uploaded as attachments in the eFiling system if the exclusive representative eFiles its petition.

Paragraph (c) of this section is amended to state that a statement of position filed electronically through use of the FLRA's eFiling system satisfies the content requirements of this paragraph, and that a statement need not be dated if it is eFiled. Paragraph (c) also is amended to state that copies of statement forms are available on the FLRA's Web site. Finally, paragraph (c)(2) is amended to state that documents submitted along with a statement may be uploaded as attachments in the eFiling system if the agency eFiles its statement.

Paragraph (c) of this section is amended to state that a response filed electronically through use of the FLRA's eFiling system satisfies the content requirements of this paragraph, and that a response need not be dated if it is eFiled. Paragraph (c) also is amended to state that copies of response forms are available on the FLRA's Web site. Finally, paragraph (c)(1) is amended to state that documents submitted along with a response may be uploaded as attachments in the FLRA's eFiling system if the exclusive representative eFiles its response.

Paragraph (c) of this section is amended to state that a reply filed electronically through use of the FLRA's eFiling system satisfies the content requirements of this paragraph, and that a reply need not be dated if it is eFiled. Paragraph (c) also is amended to state that copies of reply forms are available on the FLRA's Web site. Finally, paragraph (c) is amended to state that documents submitted along with a reply may be uploaded as attachments in the FLRA's eFiling system if the agency eFiles its reply.

This section is amended to state that part 2425 is applicable to all arbitration cases in which exceptions are filed with the Authority, pursuant to 5 U.S.C. 7122, on or after June 4, 2012.

Paragraph (a) of this section is amended to state that arbitration exceptions filed electronically through use of the FLRA's eFiling system need not be dated. In addition, paragraph (a)(3) of this section is amended to provide that documents may be uploaded as attachments in the FLRA's eFiling system if the excepting party uses that system to file exceptions.

Paragraph (d) of this section is amended to provide that an exception form is provided on the FLRA's Website, and that filing an exception electronically through use of the FLRA's eFiling system complies with the formatting requirements of this paragraph.

This section is amended to provide that an opposition form is provided on the FLRA's Web site. It also is amended to provide that filing an opposition electronically through use of the FLRA's eFiling system complies with the formatting requirements of this section, and that documents may be uploaded as attachments in the eFiling system if the opposing party uses that system to file an opposition.

This section is renamed, “How to compute the due date for filing documents with the FLRA; how the FLRA determines the date on which documents have been filed.”

Paragraph (a) of this section is renamed, “How to compute the due date for filing documents with the FLRA,” and is revised to clarify the existing rules regarding how to calculate the due date for filing documents with the FLRA. Paragraph (a)(1) is revised to specify that, if the last day of the filing period falls on a Saturday, Sunday, or federal legal holiday, then the due date falls to the next day that is not a Saturday, Sunday, or federal legal holiday, even if the party is eFiling.

Paragraph (b) of this section is renamed, “How the FLRA determines the date on which documents have been filed,” and is revised to clarify the existing rules regarding how the FLRA determines the date on which a party has filed documents. Paragraph (b)(1)(v) adds that, if a party files documents electronically through use of the FLRA's eFiling system, then the date of filing is the calendar day (including Saturdays, Sundays, and federal legal holidays) on which the document is transmitted in the eFiling system. It also notes that, consistent with paragraph (a)(1)(v), an eFiled document is not required to be filed on a Saturday, Sunday, or federal legal holiday.

This section is renamed, “Additional time for filing with the FLRA if you are filing in response to a document that has been served on you by first-class mail or commercial delivery,” and is divided into paragraphs.

Paragraph (a) of this section, “General rules,” clarifies the existing, general rules regarding adding 5 days to the filing period when a party is filing in response to a document that has been served on that party by first-class mail or commercial delivery.

Paragraph (b) of this section, “Rules that apply when you have been served by more than one method,” explains the rules that apply when a filing party is filing in response to a document that has been served on that party by more than one method. It provides that, as a general rule, the first method of service is controlling for purposes of determining the due date for a responsive filing. It also provides that the filing party is entitled to the additional 5 days only if first-class mail or commercial delivery is the first method of service. It further provides that, if a party is served by first-class mail or commercial delivery on one day, and served by any method other than first-class mail or commercial delivery on the same day, then the party may not add 5 days—even if the served document was postmarked or deposited with a commercial-delivery service earlier in the day than the other method(s) of transmission.

Paragraph (c) of this section, “Exception for applications for review filed under 5 CFR 2422.31,” restates an existing rule that a filing party does not receive an extra 5 days to file an application for review under 5 CFR 2422.31.

Paragraph (d) of this section, “Exception where extension of time has been granted,” restates an existing rule that a filing party does not get an extra 5 days if that party already has received an extension of time.

Paragraph (e) of this section, “Rules that apply to exceptions to arbitration awards,” refers the reader to 5 CFR 2425.2(c) for rules that apply when a party is filing exceptions to an arbitration award.

Paragraph (a) of this section is amended to clarify that the rules in paragraph (a) apply to documents filed with the Authority, and not documents filed with the General Counsel, a Regional Director, or an Administrative Law Judge. It also is amended to clarify that the times discussed in the paragraph are Eastern Time (“E.T.”). Further, it is amended to provide that documents that are filed electronically through use of the FLRA's eFiling system may be filed on any calendar day—including Saturdays, Sundays, and federal legal holidays, although they are not required to be filed on those days—and will be considered filed on a particular day if they are filed by midnight E.T. that day. Finally, paragraph (a) is amended to clarify that documents may not be filed with the Authority by email.

Paragraph (e) of this section is amended to provide that the general rule in the first sentence of existing paragraph (e) is subject to new paragraphs (f) and (g), and to move the existing exceptions discussed in current paragraph (e) to paragraph (g).

New paragraph (f) of this section provides that, as an alternative to filing by the methods discussed in paragraph (e), a party may file the following 11 types of documents electronically through use of the FLRA's eFiling service: (1) Applications for review under 5 CFR 2422.31(a)-(c); (2) oppositions to applications for review under 5 CFR 2422.31(d); (3) exceptions to Administrative Law Judges' decisions under 5 CFR 2423.40(a); (4) oppositions to exceptions to Administrative Law Judges' decisions under 5 CFR 2423.40(b); (5) cross-exceptions under 5 CFR 2423.40(b); (6) exclusive representatives' petitions for review under 5 CFR 2424.22; (7) agency statements of position under 5 CFR 2424.24; (8) exclusive representatives' responses under 5 CFR 2424.25; (9) agency replies under 5 CFR 2424.26; (10) exceptions to arbitration awards under 5 CFR part 2425; and (11) oppositions to exceptions to arbitration awards under 5 CFR part 2425.

New paragraphs (g)(1)-(4) of this section clarify the existing rules (currently in paragraph (e)) for filing certain documents by facsimile.

New paragraph (h) of this section restates an existing requirement (currently in paragraph (f)) that matters filed under § 2429.24 be legibly printed, typed, or otherwise duplicated. It also deletes the sentence, “Carbon copies of typewritten matter will be accepted if they are clearly legible,” as parties generally do not submit such carbon copies. Further, new paragraph (h) provides that, for purposes of documents that are filed electronically through use of the eFiling system, “legibly duplicated” means that documents that are uploaded as attachments in the eFiling system must be legible.

Paragraph (i) of this section restates, more clearly, existing wording (currently in paragraph (g)).

Paragraph (j) of this section restates existing paragraph (h) and adds that, for documents that are eFiled, the documents must contain the mailing address, email address, and telephone number of the individual who is filing the document, but not that individual's signature.

Paragraph (k) of this section restates and clarifies existing paragraph (i).

This section is revised and divided into paragraphs.

New paragraph (a) of this section, “General rule,” restates and clarifies the existing, general rule regarding the number of copies and paper size of documents that are filed with the Authority, General Counsel, Administrative Law Judge, Regional Director, or Hearing Officer. It also provides that the general rule is subject to the exceptions set forth in new paragraph (b).

New paragraph (b)(1), (3), and (4) of this section restate and clarify the existing exceptions to the general rule that is now set forth in paragraph (a). New paragraph (b)(2) adds a new exception for documents that are filed electronically through use of the FLRA's eFiling system.

Paragraph (b) of this section is revised and divided into paragraphs (1) through (6). Paragraphs (1) through (5) restate existing, authorized methods of service. Paragraph (6) states that parties may serve one another by email, but only if the receiving party agrees to email service.

Paragraph (c) of this section clarifies the existing requirements regarding filing statements of service with the FLRA. It also states that, for documents that are eFiled, the filing party or individual must certify, in the eFiling system and at the time of filing, that copies of the filing and any supporting documents have been served on the appropriate individuals specified in § 2429.27(a). Finally, paragraph (c) provides that statements of service must be signed and dated, unless they are eFiled.

Paragraph (d) of this section clarifies the existing rules regarding calculating the date of service, and adds that, for documents served by email, the date of service is the date on which the documents were transmitted by email.

This section is amended to provide that the existing table-of-contents requirement for documents exceeding 10 double-spaced pages in length applies to briefs that are uploaded as attachments in the eFiling system, but that a party using the fillable forms on the FLRA's eFiling system is not required to submit a separate table of contents.

The FLRA is an independent regulatory agency, and as such, is not subject to the requirements of E.O. 12866.

The FLRA is an independent regulatory agency, and as such, is not subject to the requirements of E.O. 13132.

Pursuant to section 605(b) of the Regulatory Flexibility Act, 5 U.S.C. 605(b), the Chairman of the FLRA has determined that this rule, as amended, will not have a significant impact on a substantial number of small entities, because this rule applies only to federal agencies, federal employees, and labor organizations representing those employees.

This rule change will not result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This action is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

The amended regulations contain no additional information collection or record-keeping requirements under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501,et seq.

For the reasons stated in the preamble, the FLRA amends 5 CFR Parts 2423, 2424, 2425, as follows:

Multnomah County has requested that the Hawthorne lift bridge remain closed to vessel traffic to facilitate safe, uninterrupted roadway passage of participants of the Rock-n-Roll Half Marathon event. The Hawthorne Bridge crosses the Willamette River at mile 13.1 and provides 49 feet of vertical clearance above Columbia River Datum 0.0 while in the closed position. Vessels which do not require a bridge opening may continue to transit beneath the bridge during this closure period. Under normal conditions this bridge operates in accordance with 33 CFR § 117.897 which allows for the bridge to remain closed between 7 a.m. and 9 a.m. and 4 p.m. and 6 p.m. Monday through Friday. This deviation period is from 4 a.m. on May 20, 2012 through 10 a.m. May 20, 2012. The deviation allows the Hawthorne Bridge across the Willamette River, mile 13.1, to remain in the closed position and need not open for maritime traffic from 4 a.m. through 10 a.m. on May 20, 2012. The bridge shall operate in accordance to 33 CFR 117.897 at all other times. Waterway usage on this stretch of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft. Mariners will be notified and kept informed of the bridge's operational status via the Coast Guard Notice to Mariners publication and Broadcast Notice to Mariners as appropriate. The draw span will be required to open, if needed, for vessels engaged in emergency response operations during this closure period.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

On October 12, 2011, MDE submitted revisions to its SIP for the GenOn Chalk Point generating station located at 25100 Chalk Point Road in Aquasco, Maryland. These revisions approve a 2011 Consent Decree between MDE and GenOn to control PM, SOXand NOXfrom Chalk Point. These revisions also remove the 1978 and 1979 Consent Orders for Chalk Point from the Maryland SIP as those Consent Orders have been superseded by the 2011 Consent Decree. The purpose of the 2011 Consent Decree is to address stack test violations at Chalk Point Unit #4. As part of the settlement with MDE, GenOn has agreed to combust natural gas in Units #3 and #4 for no less than 75% of the annual heat input of the units, and for at least 95% of the ozone season (May 1st—September 30th) heat input instead of #6 fuel oil. Burning natural gas instead of #6 fuel oil results in a significant decrease in emissions of PM, SOXand NOX. These SIP revisions to reduce PM, SOX, and NOXemissions are beneficial for reducing ambient levels of the criteria pollutants PM, SO2, and NO2. As NOXis a precursor pollutant of ground level ozone, these reductions are also beneficial for reducing ambient levels of the criteria pollutant ozone. In addition, these revisions reduce visible emissions from Chalk Point.

The Chalk Point generating station consists of four steam electric generating units located in Aquasco, Maryland which is part of Prince George County. Units #1 and #2 are coal fired baseload units each rated at 355 megawatts. Units #3 and #4 are cycling units permitted to burn natural gas and oil, each rated at 640 megawatts. Consent Orders signed in 1978 and 1979 with the Potomac Electric Power Company (Pepco, the former owner) allowed Chalk Point Units #1-#3 to combust higher sulfur fuels than Maryland regulations allow and Unit #3 was also allowed to emit higher PM and visible emissions than Maryland regulations allow. In 2006, MDE and Pepco signed a Consent Decree to address opacity (visible emissions) violations from Chalk Point Units #3 and #4. That 2006 Consent Decree required Units #3 and #4 to burn natural gas during the ozone season for 95% of the heat input. The 2006 Consent Decree for Chalk Point also terminated the 1978 and 1979 Consent Orders with Pepco, effective May 1, 2007. However, the Maryland SIP was not revised at that time to remove the 1978 and 1979 Consent Orders and replace them with the 2006 Consent Decree.

In 2011, MDE and GenOn (new owner of Chalk Point) signed a Consent Decree, effective on March 10, 2011, for Chalk Point which amends, restates, and replaces the 2006 Consent Decree. On October 11, 2012, MDE submitted specific provisions of the 2011 Consent Decree to EPA for approval as a SIP revision. A copy of the provisions of the 2011 Consent Decree for Chalk Point for which MDE is requesting approval as SIP revisions is included in the docket for this rulemaking. Hereafter in describing the SIP revision, EPA is referring to the provisions of the 2011 Consent Decree that are being made part of the SIP. The October 11, 2012 SIP revision submittal from MDE also includes a request to remove the 1978 and 1979 Consent Orders for Chalk Point from the Maryland SIP.

Under the 2011 Consent Decree, Chalk Point Units #3 and #4 must burn natural gas for no less than 75% of the annual heat input of the units. In addition, the 2011 Consent Decree reiterates the 2006 Consent Decree's requirement that Chalk Point Units #3 and #4 use natural gas for at least 95% of the ozone season heat input. The 2011 Consent Decree also requires Chalk Point to perform a stack test for PM while burning residual fuel oil in 2011, and to perform stack testing for PM from Units #3 and #4 any calendar year that either unit exceeds 570,000 MBTU from the burning of residual fuel oil. The 2011 Consent Decree submitted for approval as a revision to the Maryland SIP also includes provisions for determining compliance, operating control equipment, determining the sulfur content of fuel, as well as recordkeeping and reporting requirements consistent with Federal regulations and the CAA.

GenOn's compliance with the 2006 Consent Decree, the requirements of which are reiterated in the 2011 Consent Decree, have resulted in significant annual emission reduction benefits because of the shift to natural gas during the ozone season. In 2005, Chalk Point Units #3 and #4 emitted 3, 978 tons per year (TPY) of NOX, 744 TPY of PM, and 12,379 TPY of sulfur oxides (SOX). In 2008, as a result of compliance with the 2006 Consent Decree, the requirements of which are reiterated in the 2011 Consent Decree, Chalk Point Units #3 and #4 emitted 446 TPY of NOX, 49 TPY of PM, and 244 TPY of sulfur oxides (SOX), thereby reducing annual emissions by 3,532 TPY, 695 TPY, and 12,135 TPY, respectively. The additional provision of the 2011 Consent Decree that requires Chalk Point Units #3 and #4 to maximize the use of natural gas during the non-ozone season will result in even further reductions of NOX, PM, and SOXand further reductions in visible emissions.

EPA's review of the SIP revisions submitted by MDE on October 12, 2011 indicates that they strengthen the SIP requirements applicable to Chalk Point; result in significant emission reductions of NOX, PM, SOXand visible emissions; and meet all applicable Federal regulations and the CAA. The SIP revisions to remove the 1978 and 1979 Consent Orders for Chalk Point are approvable as they have been superseded by the more stringent 2011 Consent Decree. Therefore, EPA is approving the SIP revisions submitted by MDE on October 12, 2011. EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today'sFederal Register, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on July 3, 2012 without further notice unless EPA receives adverse comment by June 4, 2012. If EPA receives adverse comment, EPA will publish a timely withdrawal in theFederal Registerinforming the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

This action finalizes minor amendments to the “Final Response to Petition From New Jersey Regarding SO2Emissions From the Portland Generating Station” published on November 7, 2011.See76 FR 69052. We initially proposed this rule revision in parallel with a direct final rule because we viewed this as a noncontroversial action and anticipated no adverse public comments. However, the EPA did receive one adverse comment, and therefore we have withdrawn the direct final rule. In this document, we have addressed the public comment received on the proposal and are finalizing the “Revisions to Final Response to Petition From New Jersey Regarding SO2Emissions From the Portland Generating Station” published on December 22, 2011.See76 FR 79574.

The preamble and rule text to the “Final Response to Petition From New Jersey Regarding SO2Emissions From the Portland Generating Station” (76 FR 69052) contain minor misstatements that the EPA is revising in this action. In the preamble section IV.A,Summary of the Modeling for the Proposed Rule,the EPA inadvertently referred to four specific counties in New Jersey when discussing violations of the 1-hour SO2NAAQS. The statement reads, “The EPA also modeled the emissions from Portland using the AERMOD dispersion model and determined that the modeled concentrations from Portland, when combined with the relatively low background concentrations, cause violations of the 1-hour SO2NAAQS in Morris, Sussex, Warren and Hunterdon Counties in New Jersey.” (Seeid. at 69057.) This conclusion is not correctly stated as the EPA's modeling did not separately examine air quality in each of the four counties identified. A more accurate description of the EPA's conclusion was presented in the April 7, 2011, proposal (76 FR 19662 at 19680) which did not refer to those counties in our explanations of the modeling results. Furthermore, between proposal and promulgation, the EPA did not separately examine each of the four counties identified, so in the final rule there was no reason to change this proposed description to specifically list counties. Therefore, we are now revising the statement in the November 7, 2011, final rule preamble to be consistent with the description in the April 7, 2011, proposal by removing the references to Morris, Sussex, Warren, and Hunterdon Counties. The statement will now read, “The EPA also modeled the emissions from Portland using the AERMOD dispersion model and determined that the modeled concentrations from Portland, when combined with the relatively low background concentrations, cause violations of the 1-hour SO2NAAQS in New Jersey.”

Similarly, in the rule text, Part 52—[Amended], Subpart NN—Pennsylvania, section 52.2039 in 40 CFR part 52, of the final rule, the EPA inadvertently referred to those same four counties in describing the finding of significant contribution to nonattainment and interference with maintenance of the 1-hour SO2NAAQS. The provision reads, “The EPA has made a finding pursuant to section 126 of the Clean Air Act (the Act) that emissions of sulfur dioxide (SO2) from the Portland Generating Station in Northampton County, Upper Mount Bethel Township, Pennsylvania (Portland) significantly contribute to nonattainment and interfere with maintenance of the 1-hour SO2national ambient air quality standard (NAAQS) in Morris, Sussex, Warren, and Hunterdon Counties in New Jersey.” With this action, the rule text now reads, “The EPA has made a finding pursuant to section 126 of the Clean Air Act (the Act) that emissions of sulfur dioxide (SO2) from the Portland Generating Station in Northampton County, Upper Mount Bethel Township, Pennsylvania (Portland) significantly contribute to nonattainment and interfere with maintenance of the 1-hour SO2national ambient air quality standard (NAAQS) in New Jersey.”

Although the New Jersey Department of Environmental Protection (NJDEP) modeling analysis submitted with the September 2010 petition identified NAAQS violations at receptors in certain counties, the purpose of the EPA modeling was not to identify or corroborate the entire geographic footprint of the violations in New Jersey. The EPA modeling analysis was conducted for the purpose of corroborating the existence of NAAQS violations in New Jersey caused by Portland and for determining the remedy needed to eliminate all NAAQS violations caused by Portland. The EPA modeling thus focused upon identifying only the area where the maximum concentration was expected to occur. We used the same receptor grid for the final rule as for the proposed rule, which was focused on the area of maximum impacts occurring in Warren County, New Jersey. The remedy was determined by assessing the emission reduction needed to eliminate the maximum modeled violation in New Jersey, which occurs in close proximity to Portland in Warren County. There was no need to make an assessment of impacts at all locations within New Jersey since eliminating the NAAQS violations at the highest impacted receptor provided the basis for the remedy which, by its nature, would eliminate all modeled violations caused by Portland in the entire state. Therefore, the EPA finding pursuant to section 126 of the Clean Air Act (the Act) applies to New Jersey generally. The revision is consistent with NJDEP's request for a finding that emissions from Portland significantly contribute to nonattainment or interfere with maintenance of the 1-hour SO2NAAQS in New Jersey. The revision is also consistent with the language in sections 110 and 126 of the Act which is phrased such that the petitioner can request a finding that a source in one state is significantly contributing to nonattainment or interfering with maintenance of the NAAQS in another state. The addition of the counties was neither necessary nor intentional and did not arise from a request from the petitioner or any other commenter.

The revisions will not affect the emission limits, increments of progress, compliance schedules, or reporting provisions specified in the November 7, 2011, final rule and do not change theconclusions that the EPA made in the final rule. No adjustments to the existing modeling or other technical analyses and no new analyses were necessary to make the revisions.

On February 21, 2012, the Pennsylvania Department of Environmental Protection (PADEP) provided comments to the EPA on the direct final rule and the concurrent proposal for this rule. The direct final rule was subsequently withdrawn. (See77 FR 15608.)

PADEP commented that our revision to the November 7, 2011, final rule is a “revision” to a final rule which, in light of other similar actions, constitutes a pattern for EPA. PADEP specifically refers to recent revisions to the final Cross-State Air Pollution Rule (CSAPR) as an example of this alleged pattern. The commenter argues that this alleged pattern is the result of a “rush to judgment” causing mistakes to be made. The commenter claims that the EPA admits that the inadvertent reference to the four counties in New Jersey was a “major misstatement” and that the EPA committed a significant error with respect to the air modeling.

The EPA does not agree that the revisions to the final rule resulted from any significant errors with the modeling nor did we characterize the issue as a major misstatement. As explained in the December 22, 2011, notice of the proposed revision (76 FR 79541), we inadvertently made reference to the four counties in New Jersey in the November 7, 2011, final rule. (See76 FR at 69077; 40 CFR 52.2039.) This was inconsistent with the correct characterization of the finding described in the April 7, 2011, proposal (76 FR at 19680) in which the finding was proposed for the State of New Jersey generally and not in specific counties within the state. The changes do not affect the emission limits, increments of progress, compliance schedules, or the reporting provisions of the final rule.

Moreover, the commenter's claim that these misstatements demonstrate a significant error in the air modeling is unsupported. First, as explained above, the modeling was targeted at corroborating the existence of NAAQS violations in New Jersey caused by Portland and determining the remedy needed to eliminate all NAAQS violations caused by Portland. The EPA modeling thus focused on identifying the area where the maximum concentration was expected to occur, which was identified as Warren County, New Jersey, and assessing the emission reduction needed to eliminate the maximum modeled violation in New Jersey. The commenter has failed to identify any error in this modeling approach. Therefore, no new technical analyses or any changes to the modeling are necessary to make these revisions. Second, comments on the modeling are beyond the scope of comment solicited by the proposal since no modifications to the modeling approach were proposed in this rule. If the commenter wished to raise any concerns with respect to the scope of EPA's modeling approach, they should have been raised when the modeling approach was initially proposed. Finally, comments regarding CSAPR are clearly beyond the scope of this rulemaking as CSAPR is a separate and unrelated rulemaking.

The comment provides no basis for us to change the characterization of our finding, namely that emissions from Portland significantly contribute to nonattainment or interfere with maintenance of the 1-hour SO2NAAQS in New Jersey. Therefore, we are not making any changes to the December 22, 2011, proposal in this final rule.

This action revises minor wording errors in the November 7, 2011, final rule. This action corrects a response to a petition that is narrow in scope and affects a single facility. This type of action is exempt from review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).

This action does not impose an information collection burden under the provisions of thePaperwork Reduction Act,44 U.S.C. 3501et seq.,because under section 126 of the CAA, it will not create any new information collection burdens but revises minor wording errors in the November 7, 2011, rule. Burden is defined at 5 CFR 1320.3(b).

The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule 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. Small entities include small businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of this rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of this rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. The revisions in this action do not impose any new requirements on small entities. This action revises minor wording errors in the November 7, 2011, rule. These revisions clarify the EPA's finding that Portland significantly contributes to nonattainment or interferes with maintenance of the 1-hour SO2NAAQS in the State of New Jersey, and removes the specific references to the New Jersey counties identified in the November 7, 2011, rule.

This action does not contain a federal mandate under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538 for State, local or tribal governments or the private sector. This action is not expected to result in expenditures of $100 million or more for state, local, and tribal governments, in the aggregate, or the private sector in any 1 year. This action makes minor wording revisions to the November 7, 2011, final rule. These revisions clarify the EPA's finding that Portland significantly contributes to nonattainment or interferes with maintenance of the 1-hour SO2NAAQS in the State of New Jersey, and removes the specific references to the New Jersey counties identified in the November 7, 2011, rule. Thus, this rule is not subject to the requirements of sections 202 or 205 of UMRA.

This rule is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. The November 2011 final rule primarily affects private industry, and does not impose significant economic costs on state or local governments. This action revises minor wording errors in the November 7, 2011, rule. These revisions clarify the EPA's finding that Portland significantly contributes to nonattainment or interferes with maintenance of the 1-hour SO2NAAQS in the State of New Jersey, and removes the specific references to the New Jersey counties identified in the November 7, 2011, rule. Thus, Executive Order 13132 does not apply to this action.

This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have a substantial direct effect on tribal governments, on the relationship between the federal government and Indian tribes, or the distribution of power and responsibilities between the federal government and Indian tribes. This action revises minor wording errors in the November 7, 2011, rule.

The EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks.

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 the 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 the EPA to provide Congress, through OMB, explanations when the agency decides not to use available and applicable voluntary consensus standards.

This rulemaking does not involve technical standards. Therefore, the EPA is not considering the use of any voluntary consensus standards.

Executive Order 12898 (59 FR 7629, February 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.

The 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. This action revises minor wording errors in the November 7, 2011, rule. These revisions clarify the EPA's finding that Portland significantly contributes to nonattainment or interferes with maintenance of the 1-hour SO2NAAQS in the State of New Jersey, and removes the specific references to the New Jersey counties identified in the November 7, 2011, rule.

The Congressional Review Act, 5 U.S.C. 801et 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. Section 804 exempts from section 801 the following types of rules (1) Rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). The EPA is not required to submit a rule report regarding this action under section 801 because this is a rule of particular applicability. Nonetheless, this action will be effective June 4, 2012.

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the Third Circuit Court within 60 days from the date the final action is published in theFederal Register, Filing a petition for review by the Administrator of this final action 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 must be filed, and shall not postpone the effectiveness of such action.

For the reasons set forth in the preamble part 52 of chapter I of title 40 of the Code of Federal regulations are amended as follows:

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

Table 1 lists the rule we are rescinding and the rules we are approving with the dates that they were adopted by the local air agencies and submitted by the California Air Resources Board (CARB).

On July 15, 2011, EPA determined that the submittal for AVAQMD Rule 1119, EKAPCD Rule 102, and SBCAPCD Rule 102 met the completeness criteria in 40 CFR Part 51 Appendix V, which must be met before formal EPA review.

We approved earlier versions of these rules into the SIP on the dates listed: AVAQMD Rule 1119 on September 28, 1981 (46 FR 47451), EKAPCD Rule 102 on March 7, 2011 (76 FR 12280), and SBCAPCD Rule 102 on May 6, 2009 (74 FR 20872). The SBCAPCD amended revisions to the SIP-approved version on September 20, 2010 and CARB submitted them to us on April 5, 2011. While we can act on only the most recently submitted version, we have reviewed materials provided with previous submittals.

Section 110(a) of the CAA requires states to submit regulations that control volatile organic compounds, oxides of nitrogen, particulate matter, and other air pollutants which harm human health and the environment. These rules were developed as part of the local agency's program to control these pollutants.

Antelope Valley AQMD Rule 1119 applies to the operation of petroleumcoke calcining equipment. The AVAQMD has determined that there are no petroleum coke calcining operations located within the District and none are anticipated in the future. The AVAQMD has rescinded this rule and has certified that there are no sources covered by this rule in the jurisdiction of the AVAQMD. Since this rule is currently part of the SIP for AVAQMD, a resolution certifying that no sources exist in the AVAQMD is required by section 182(b)(2).

Eastern Kern APCD Rule 102, Definitions, is being amended to define a number of terms that are used in other District rules. The amendments include updating the name of the District, adding ten new definitions, revising language in three definitions, and adding one compound to the Exempt Compounds list. Minor formatting issues are also being corrected.

Santa Barbara County Rule 102, is amended by adding a new definition for “greenhouse gas or greenhouse gases.” In addition, the definition of “attainment pollutant” has been clarified to exclude greenhouse gases.

EPA's technical support documents (TSDs) have more information about these rules.

These rules describe administrative provisions and definitions that support emission controls found in other local agency requirements. In combination with the other requirements, these rules must be enforceable (see section 110(a) of the Act) and must not relax existing requirements (see sections 110(l) and 193). EPA policy that we used to evaluate enforceability requirements consistently includes the Bluebook (“Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988) and the Little Bluebook (“Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001).

We believe these rules are consistent with the relevant policy and guidance regarding enforceability and SIP relaxations. The TSDs have more information on our evaluation.

As authorized in section 110(k)(3) of the Act, EPA is fully approving the submitted rules because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of thisFederal Register, we are simultaneously proposing approval of the same submitted rules. If we receive adverse comments by June 4, 2012, we will publish a timely withdrawal in theFederal Registerto notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on July 3, 2012. This will incorporate these rules into the federally enforceable SIP.

Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

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 disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, these rules do 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 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 theFederal Register. A major rule cannot take effect until 60 days after it is published in theFederal 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 3, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the Proposed Rules section of today'sFederal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final ruleand address the comment in the proposed rulemaking. This action may not be challenged in later proceedings to enforce its requirements (see section 307(b)(2)).

Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows:

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 underFOR 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 athttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-0179 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 3, 2012. 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 hearingrequest, identified by docket ID number EPA-HQ-OPP-2011-0179, by one of the following methods:

•Federal eRulemaking Portal: http://www.regulations.gov. Follow the online 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 theFederal Registerof April 20, 2011 (76 FR 22067) (FRL-8869-7), 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 0F7807) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide metconazole, 5-[(4-chlorophenyl)methyl]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol, measured as the sum of cis- and trans-isomers, in or on sugarcane, cane at 0.06 parts per million (ppm); and sugarcane, molasses at 0.08 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, tolerances for sugarcane, molasses are not being established. The reason for this change is 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 metconazole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with metconazole 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.

Acute oral and dermal toxicities to metconazole are moderate, while acute inhalation toxicity is low. Metconazole is a moderate eye irritant and a mild skin irritant. It is not a skin sensitizer.

Metconazole was shown to affect the liver, kidney, spleen, and certain blood parameters in all the species tested. Dose levels at which these effects occur are similar across species with the rat and dog being slightly more sensitive than the mouse. Like other triazoles, a primary target organ in mammalian toxicity studies is the liver. Liver toxicity was seen in the mouse, rat and dog following oral exposure to metconazole via subchronic or chronic exposure durations. While liver effects have been reported consistently across multiple durations and species, these effects were considered slight and minimal in some studies and appeared to be “adaptive” responses. However, based on the weight of evidence from the consistency of these reported effects and evidence that these effects increase in severity with duration, and leading to liver tumors in the chronic mouse study, they were considered “adverse” and formed the basis of the study lowest observed adverse effect levels (LOAELs). Metconazole is considered nongenotoxic and the liver tumors appear to have been formed via a mitogenic mode of action and therefore, metconazole is classified as “not likely to be carcinogenic to humans” at levels that do not cause mitogenesis. There is evidence of liver effects (microsomal induction, liver weight increases, hypertrophy) at 47.6 milligrams/kilograms/day (mg/kg/day), but no effects at 4.5 mg/kg/day in the mode of action studies in the mouse. There is no concern for mutagenicity. The chronic Reference Dose of 0.04 mg/kg/day based on the 2-year chronic rat study with a no observed adverse effect level (NOAEL) of 4.3 mg/kg/day would be protective of early liver disturbances seen in the mouse studies. Therefore, the Agency has determined that the quantification of risk using a non-linear approach (i.e., Reference dose (RfD)) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to metconazole.

Other major critical effects observed in oral studies were decreased body weight, decreased body weight gains, and blood effects (reductions in erythrocyte and/or platelet parameters) in the mouse, rat, dog and/or rabbit. Splenic effects including increased spleen weight and hyperplasia were observed in the mouse, rat and dog at dose levels where liver effects were also observed. In dogs, lenticular degeneration (cataracts) was observed at the highest dose tested (HDT) (114 mg/kg/day). Furthermore, at high dietary levels, there is evidence that metconazole is a gastrointestinal irritant in the dog.

There was no evidence of immunotoxicity at dose levels that produced systemic toxicity. No immunotoxic effects are evident for metconazole at dose levels as high as 52 mg/kg/day in rats, which is 12 times higher than the chronic dietary point of departure (4.3 mg/kg/day).

Metconazole did not demonstrate neurotoxicity in the standard battery of tests submitted. Information available from the submitted studies including acute, subchronic and chronic studies in several species, developmental toxicity studies in the rat and rabbit and a 2-generation reproduction study in the rat do not indicate any neurotoxic signs. No effects were noted on brain weights and no clinical signs possibly related to neurotoxicity were noted up to and including the high doses in all studies.

Specific information on the studies received and the nature of the adverse effects caused by metconazole as well as the NOAEL and the LOAEL from the toxicity studies can be found athttp://www.regulations.govin document “Metconazole: Human Health Risk Assessment for Proposed Uses on Sugarcane,” at page 36 in docket ID number EPA-HQ-OPP-2011-0179.

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, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for metconazole used for human risk assessment is shown in the following Table.

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to metconazole, EPA considered exposure under the petitioned-for tolerances as well as all existing metconazole tolerances in 40 CFR 180.617. EPA assessed dietary exposures from metconazole in food as follows:

i.Acute exposure.Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for metconazole. 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 made the following assumptions for the acute exposure assessment: Tolerance-level residues and 100 percent crop treated (PCT). EPA used Dietary Exposure Evaluation Model (DEEMTM) version 7.81 default processing factors.

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 made the following assumptions for the chronic exposure assessment: Tolerance-level residues and 100 PCT. EPA used DEEMTMversion 7.81 default processing factors.

iii.Cancer.Based on the data summarized in Unit III.A., EPA has determined that the quantification of risk using a non-linear approach will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to metconazole. Therefore, the chonic RfD is expected to be protective of chronic toxicity including carcinogenicity. For the purpose of assessing cancer risk under this approach EPA relied upon the exposure estimate discussed in Unit III.C.1.ii.

iv.Anticipated residue and PCT information.EPA did not use anticipated residue and/or PCT information in the dietary assessment for metconazole. Tolerance level residues and/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 metconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of metconazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found athttp://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 metconazole for acute exposures are estimated to be 45.48 parts per billion (ppb) for surface water and 0.38 ppb for ground water.

Chronic exposures for non-cancer assessments are estimated to be 38.16 ppb for surface water and 0.38 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 45.48 ppb was used to assess the contribution to drinking water.

For chronic dietary risk assessment, the water concentration of value 38.16 ppb was used to assess the contribution to drinking water.

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

Metconazole is currently registered for the following uses that could result in residential exposures: Turf and ornamentals. EPA assessed residential exposure using the following assumptions: Adults, adolescents and children may be exposed to metconazole from its currently registered turf and ornamental uses. Adults and adolescents may experience short- and intermediate-term dermal exposure from golfing and other activities on treated turf, as well as from tending treated ornamentals. Children may experience short- and intermediate-term dermal and incidental oral exposure from activities on treated turf. However, because dermal toxicity endpoints for the appropriate durations of exposure were not identified, and because inhalation exposure is considered to be insignificant for postapplication exposures, only children's incidental oral postapplication exposures have been assessed. Postapplication risks to children following the application of metconazole to home lawns were calculated for short- and intermediate-term incidental oral exposures. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

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

Metconazole is a member of the triazole-containing class of pesticides. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute 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 (EPA, 2002). In conazoles, however, a variable pattern of toxicological responses is found; some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's Web siteat http://www.epa.gov/pesticides/cumulative.

Triazole-derived pesticides can form the metabolite 1,2,4-triazole (T) and two triazole conjugates triazolylalanine (TA) and triazolylacetic acid (TAA). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, EPA conducted an initial human-health risk assessment for exposure to T, TA, and TAA resulting from the use of all current and pending uses of any triazole-derived fungicide as of September 1, 2005. The risk assessment was a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high-end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the additional 10X Food Quality Protection Act (FQPA) safety factor (SF) for the protection of infants and children. The assessment included evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's complete risk assessment can be found in the propiconazole reregistration docket athttp://www.regulations.gov,Docket Identification (ID) Number EPA-HQ-OPP-2005-0497 and an update to the aggregate human health risk assessment for free triazoles and its conjugates may be found in Docket Identification (ID) Number EPA-HQ-OPP-2011-0179 entitled “Common Triazole Metabolites: Updated Aggregate Human Health Risk Assessment to Address Tolerance Petitions for Metconazole.”

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 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.Developmental studies in rats and rabbits show some evidence of developmental effects, but only at dose levels that are maternally toxic. There was no quantitative susceptibility to the fetuses of rats or rabbits followingin uteroexposure to metconazole. In the developmental toxicity study in rats, skeletal variations (predominantly lumbar ribs) occurred in the presence of maternal toxicity (decreased body weight gains). In the prenatal developmental toxicity study in rabbits, developmental effects (increased post-implantation loss and reduced fetal body weights) were observed at the same dose that caused maternal toxicity (decreased body weight gains, reduced food consumption and alterations in hematology parameters). In the 2-generation reproduction study in rats, offspring toxicity (reduced fetal body weights F2 offspring and decreased viability in F1 and F2 offspring) was observed only at the HDT, a dose which also resulted in parental toxicity as evidenced by reduced parental body weight and body weight gains, increased incidence of fatty hepatocyte changes in male parental animals and increased incidence of spleen congestion in F1 parental females. In the rat study, there is a concern for qualitative susceptibility (skeletal variation in the presence of minimal maternal toxicity) due to the presence of more severe effects at higher dose levels such as post-implantation loss, hydrocephaly and visceral anomalies. However, there is a clear NOAEL for these effects and the point of departure for this endpoint is based on skeletal variations. Therefore, it is concluded that there is no residual uncertainty for prenatal and/or postnatal toxicity.

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:

• The toxicity database is complete except for an acute neurotoxicity study.

• There is no concern for neurotoxicity with metconazole. However, in accordance with the revised 40 CFR part 158 data requirements, a neurotoxicity battery is required for risk assessment. The existing metconazole database does not include an acute neurotoxicity study, and thus remains a data deficiency. An acceptable subchronic neurotoxicity study showed no neurotoxic effects at levels that produced systemic toxicity in the study, as well as in other subchronic and chronic studies. Therefore, concern for potential neurotoxicity is low and the 10X FQPA factor is not retained.

• There is no evidence of susceptibility followingin uteroexposure in the rabbit developmental study. In the rat developmental study there is qualitative evidence of susceptibility, however the concern is low since the developmental effects occur in the presence of maternal toxicity, the NOAELs are well defined, and the dose/endpoint is used for acute dietary risk assessment for the sensitive population. There is no evidence of increased susceptibility in the offspring based on the result of the 2-generation reproduction study. Dietary exposure assessments were conducted using tolerance level residues and assumed 100 PCT. Therefore, the acute and chronic dietary (food only) exposure is considered an upper bound conservative estimate. The contribution from drinking water is minimal. The Agency concludes that the acute andchronic exposure estimates in this analysis are unlikely to underestimate actual exposure. The drinking water component of the dietary assessment utilizes water concentration values generated by model and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations which will not likely be exceeded. While there is potential for postapplication residential exposure, the Agency used the current conservative approaches for residential assessment. Exposures are unlikely to be under estimated because the assessment was a screening level assessment.

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

1.Acute risk.Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to metconazole will occupy 3.8% of the aPAD for females 13-49 years old, the only population subgroup of concern.

2.Chronic risk.Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to metconazole from food and water will utilize 12.6% 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 metconazole is not expected.

3.Short-term risk.Short-term risk takes into account short-term residential exposure plus chronic exposure to food and drinking water (considered to be a background exposure level). Metconazole 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 metconazole.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and non-occupational/residential post application exposures result in aggregate MOEs of 420 for children 1-2 years old and 1,700 for adults. Because EPA's level of concern for metconazole is a MOE of 100 or below, these MOEs are not of concern.

4.Intermediate-term risk.Intermediate-term risk takes into account intermediate-term residential exposure plus chronic exposure to food and drinking water (considered to be a background exposure level). Metconazole is currently registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to metconazole.

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and non-occupational residential exposures result in aggregate MOEs of 460 for children 1-2 years old and 1,700 for adults. Because EPA's level of concern for metconazole is a MOE of 100 or below, these MOEs are not of concern.

5.Aggregate cancer risk for U.S. population.As explained in Unit III.A., the Agency has determined that the quantification of risk using a non-linear (i.e., RfD) approach will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to metconazole. Therefore, based on the results of the chronic risk assessment discussed in Unit III.E.2., metconazole 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 metconazole residues.

Adequate enforcement methodology (high performance liquid chromatography/tandem mass spectrometry (HPLC/MS/MS) method BASF D0604) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: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 not established a MRL for metconazole on sugarcane.

Based on the results of the sugarcane crop field data and the tolerance calculation procedures, EPA has determined that separate tolerances for sugarcane, molasses are unnecessary. The highest metconazole residue from the sugarcane field trials is 0.036 ppm. This residue multiplied by the processing factor for molasses (0.036 × 1.2) yields 0.043 ppm. As this is less than the tolerance for sugarcane, cane at 0.06 ppm, the sugarcane, cane tolerance will cover molasses.

Therefore, tolerances are established for residues of metconazole, 5-[(4-chlorophenyl)methyl]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol, including its metabolites and degradates in or on sugarcane, cane at 0.06 ppm.

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, entitledRegulatory 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, entitledActions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use(66 FR 28355, May 22, 2001) or Executive Order 13045,entitledProtection 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. 3501et seq.,nor does it require any special considerations under Executive Order 12898, entitledFederal 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. 601et 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, entitledFederalism(64 FR 43255, August 10, 1999) and Executive Order 13175, entitledConsultation 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) (Pub. L. 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. 801et 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 theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. 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 ofentities 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 underFOR 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 athttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-0428 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 3, 2012. 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-2011-0428, by one of the following methods:

•Federal eRulemaking Portal: http://www.regulations.gov. Follow the online 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 theFederal Registerof July 6, 2011 (76 FR 39360) (FRL-8875-6), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 1F7839) by FMC Corporation, 1735 Market St., Philadelphia, PA 19103. The petition requested that 40 CFR 180.515 be amended by establishing tolerances for residues of the herbicide, carfentrazone-ethyl and its metabolite, carfentrazone-ethyl chloropropionic acid, in or on alfalfa, forage at 5 parts per million (ppm); alfalfa, hay at 18 ppm; alfalfa, seed at 10 ppm; clover, forage at 5 ppm; clover, hay at 18 ppm; and clover, seed at 10 ppm. That notice referenced a summary of the petition prepared by FMC 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 the proposed individual alfalfa and clover tolerances to crop group 18 tolerances. The reason for this change is explained in Unit IV.C.

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

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

Carfentrazone-ethyl was ranked low in acute oral toxicity in rats via the oral, dermal, and inhalation routes of exposure. It was minimally irritating to eyes, non-irritating to skin, and not a skin sensitizer.

The proposed mode of action of carfentrazone-ethyl in target plants is through inhibition of the enzyme protoporphyrinogen oxidase (PPO) which is involved in chlorophyll biosynthesis. In mammals, PPO is also an important enzyme in heme biosynthesis and its inhibition can lead toxic effects where heme is utilized (e.g., red blood cells). Some of the toxicities reported for carfentrazone-ethyl are consistent with this mode of action. The target tissues/organs identified are the blood and liver and the most sensitive species was the rat. Subchronic toxicity studies in rats, mice, and dogs demonstrated that the primary effects were on hematological parameters (decreased mean corpuscular hemoglobin (MCH) and mean corpuscular volume (MCV)). There was also increased urinary porphyrin excretion, increased liver weights, and liver histopathology findings consisting of hepatic pigment deposition, hepatocytomegaly, single cell necrosis, and cell mitosis. Similarly, chronic toxicity studies in rats and dogs demonstrated increased urinary porphyrin excretion and liver histopathology findings in rats and mice consisting of liver pigmentation and increases in red fluorescence. Fluorescence microscopy on liver sections also revealed red fluorescent granules consistent with porphyrin deposits in rats and mice.

There was no evidence of increased susceptibility in prenatal developmental toxicity studies (rats and rabbits) or the multigenerational reproductive toxicity study in rats. Carfentrazone-ethyl induced a significant increase in litter incidences of wavy and thickened ribs in rats at a dose (1,250 mg/kg/day) much higher than the dose (600 mg/kg/day) that caused maternal toxicity consistent with interference with porphyrin metabolism (i.e., staining of the abdominogenital area and of the cage pan liner). The rabbit prenatal developmental toxicity study did not yield any evidence of treatment-related prenatal developmental toxicity even at the highest dose tested (HDT) (300 mg/kg/day). The offspring effects from the 2-generation reproduction study consisted of decreased pup body weight in both sexes of the F2generation at the HDT (343 mg/kg/day) and at which maternal toxicity was observed in the form of decreased body-weight gains, increased liver weights, liver and bile duct histopathology, and reductions in the mean cell volume (F0and F1males, F1females), mean cell hemoglobin (F0and F1males, F1females), hematocrit (F1males), and hemoglobin (F1males).

There is no concern for neurotoxicity. The results of the acute neurotoxicity study indicate clinical signs (i.e., salivation) and mild decreases in motor activity only on the treatment day and the subchronic neurotoxicity showed no signs of neurotoxicity up to the limit dose (1,178 mg/kg/day for males and 1,434 mg/kg/day for females).

In a 21-day dermal toxicity study, carfentrazone-ethyl did not induce any type of dermal or systemic toxicity up to the limit dose of 1,000 mg/kg/day. There are no toxicity studies based on repeated inhalation exposures to carfentrazone-ethyl. A waiver of a 28-day inhalation toxicity study was previously accepted based on its relatively low volatility, low acute inhalation lethality, and the large inhalation MOEs associated with the requested applications.

The mutagenic test battery demonstrated that carfentrazone-ethyl is not mutagenic. In accordance with the Draft Proposed Guidelines for Carcinogen Risk Assessment (April, 1999), carfentrazone-ethyl is classified as a “not likely human carcinogen,” based on the lack of evidence for carcinogenicity in the mouse and rat.

Specific information on the studies received and the nature of the adverse effects caused by carfentrazone-ethyl 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 athttp://www.regulations.govin document: “Carfentrazone-ethyl. Section 3 Registration for Application to the Non-grass Animal Feed Crop Group 18. Human-Health Risk Assessment” pp. 30-32 in docket ID number EPA-HQ-OPP-2011-0428.

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, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for carfentrazone-ethyl used for human risk assessment is shown in the Table of this unit.

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to carfentrazone-ethyl, EPA considered exposure under the petitioned-for tolerances as well as all existing carfentrazone-ethyl tolerances in 40 CFR 180.515. EPA assessed dietary exposures from carfentrazone-ethyl in food as follows:

i.Acute and chronic 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. Since such effects were identified for carfentrazone-ethyl, both acute and chronic dietary risk assessments were conducted. In estimating acute and chronic dietary exposure, EPA used food consumption information 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 assumed tolerance-level residues or, if necessary, tolerance-level residues adjusted to account for the residues of concern for risk assessment, 100 PCT.

ii.Cancer.Based on the data summarized in Unit III.A., EPA has concluded that carfentrazone-ethyl does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk was not conducted.

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

Based on the Tier 1 Rice Model and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of carfentrazone-ethyl for acute exposures are estimated to be 126 parts per billion (ppb) for surface water and 13 ppb for ground water. Chronic exposures for non-cancer assessments are estimated to be 48 ppb for surface water and 13 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 126 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 48 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). Carfentrazone-ethyl is currently registered for the following uses that could result in residential exposures: Golf courses, residential lawns, and aquatic areas. EPA assessed residential exposure with the assumption that homeowner handlers wear shorts, short-sleeved shirts, socks, and shoes, and that they complete all tasks associated with the use of a pesticide product including mixing/loading, if needed, as well as the application. Residential handler exposure scenarios for residential lawn applications are considered to be short-term only, due to the infrequent use patterns associated with homeowner products. Therefore, short-term inhalation risk was assessed for residential handlers; however, since no hazard was identified via the dermal route of exposure, a dermal risk assessment was not conducted for residential handlers.

EPA uses the term “post-application” to describe exposure to individuals that occur as a result of being in an environment that has been previously treated with a pesticide. Carfentrazone-ethyl can be used in many areas that can be frequented by the general population including home lawns, golf courses and aquatic recreational areas such as ponds and lakes that have been treated for removal of aquatic vegetation. As a result, individuals can be exposed by entering these areas if they have been previously treated. Therefore, short-term post-application exposure and risk were also assessed for carfentrazone-ethyl. The most conservative exposure scenario for adults, the aquatic exposure scenario (combined incidental oral and inhalation), was used to estimate post-application risk. For children, the most conservative exposure scenario, the hand-to-mouth exposure in residential turf scenario (incidental oral), was used to estimate post-application risk. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found athttp://www.epa.gov/pesticides/science/residential-exposure-sop.html.

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

1.In general.Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the 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.As discussed in Unit III.A., based on the results of the rat/rabbit prenatal developmental toxicity studies and the rat 2-generation reproductive toxicity study, there is no evidence of increased pre- and/or postnatal sensitivity.

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. Although an immunotoxicity study is currently lacking in the toxicity database for carfentrazone-ethyl, there is no evidence in the current database that the immune system organs are directly affected following carfentrazone-ethyl exposure.

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

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

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to carfentrazone-ethyl in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by carfentrazone-ethyl.

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

1.Acute risk.Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to carfentrazone-ethyl will occupy 1% of the aPAD for all infants (<1 year old), 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 carfentrazone-ethyl from food and water will utilize 69% 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 carfentrazone-ethyl 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). Carfentrazone-ethyl 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 carfentrazone-ethyl. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that children (1-2 years old) provide the most conservative short-term exposure scenario. Chronic dietary estimates (food + water) for this age group, combined with incidental oral exposure from turf use (hand-to-mouth) results in aggregate MOEs of 2,300. Because EPA's level of concern for carfentrazone-ethyl 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). Although intermediate-term residential exposures are not anticipated, the relevant short-/intermediate-term PODs are the same and, therefore, the short-term risk assessment is protective of intermediate-term exposure.

5.Aggregate cancer risk for U.S. population.Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, carfentrazone-ethyl 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 carfentrazone-ethyl residues.

Adequate enforcement methodology is available to enforce the tolerance expression. This analytical enforcement method involves separate analyses for parent and the metabolite. The parent is analyzed by evaporation and reconstitution of the sample prior to analysis by LC/MS/MS GC/ECD. The metabolite is refluxed in the presence of acid and cleaned up with solid phase extraction prior to analysis by LC/MS/MS.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an internationalfood 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 no Codex, Canadian, or Mexican MRLs established for carfentrazone-ethyl in or on the requested crops.

Based on the proposed uses and the submitted data, the Agency concludes that crop group 18 tolerances are appropriate for carfentrazone-ethyl, as opposed to individual tolerances on alfalfa and clover as proposed. These crop group tolerances are based on the submitted field trial data, which were conducted on the representative commodities for crop group 18, and the Organization for Economic Co-operation and Development (OECD) tolerance calculation procedure.

Therefore, tolerances are established for residues of carfentrazone-ethyl, including its metabolites and degradates, as set forth in the regulatory text. Compliance with the tolerance levels is to be determined by measuring only the sum of carfentrazone-ethyl (ethyl-alpha-2-dichloro-5-[-4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-fluorobenzenepropanoate) and its metabolite carfentrazone-chloropropionic acid (alpha, 2-dichloro-5-[-4-difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-fluorobenzenepropanoic acid), calculated as the stoichiometric equivalent of carfentrazone-ethyl.

This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this 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. 3501et seq.,nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et 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 FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this 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) (Pub. L. 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. 801et 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 theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. 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 underFOR 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 athttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-0388 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 3, 2012. 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-2011-0388, by one of the following methods:

•Federal eRulemaking Portal: http://www.regulations.gov.Follow the online 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 theFederal Registerof July 20, 2011 (76 FR 43231) (FRL-8880-1), 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 0F7800) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709. The petition requested that EPA amend 40 CFR part 180 by raising tolerances for residues of the fungicide dimethomorph, in or on brassica, head and stem, subgroup 5A from 2.0 ppm to 5.0 ppm; brassica, leafy greens, subgroup 5B from 20.0 ppm to 30.0 ppm; green onion, subgroup 3B from 2.0 ppm to 11.0 ppm. The petition also requested that 40 CFR part 180 be amended by establishing a tolerance for the residues of the fungicide dimethomorph, in or on vegetable, leafy at 16 ppm (PP 0F7816). The noticereferenced 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.

In theFederal Registerof October 27, 2010 (75 FR 66092) (FRL-8848-3), 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 0F7751) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709. The petition requested that EPA establish a tolerance for residues of the fungicide dimethomorph, in or on grape at 3.5 ppm. The notice referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket,http://www.regulations.gov.One comment was received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

Based upon review of the data supporting the petitions, EPA has revised the proposed tolerance level and commodity definition for vegetable, bulb, group 3 and removed the established tolerance for the regional registration for grape. Tolerances for the national registration for grape and onion, bulb subgroup 3-07A were lowered. Tolerances for brassica, head and stem, subgroup 5A; brassica, leafy greens, subgroup 5B; vegetable, leafy except brassica, group 4; onion, green, subgroup 3-07B were raised. Tolerances for grape, raisin were established for domestic registrations and were also raised. EPA is also establishing rotational crop tolerances for wheat, forage; wheat, hay; and wheat, straw. EPA has made various changes to the commodity definitions and tolerance levels sought in the petition and also is establishing rotational crop tolerances. The reason 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 FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for dimethomorph including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with dimethomorph 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.

Dimethomorph has low acute toxicity via the oral and dermal routes of exposure. Chronic risk is regulated based on effects seen in body weight decrements and liver effects in the female rat. There was no evidence of increased incidence of any neoplasms at the limit dose tested in carcinogenicity studies tested in rats and mice. Dimethomorph is classified as “not likely” to be a human carcinogen based on the lack of evidence of carcinogenicity in carcinogenicity studies in rats and mice. The available data for dimethomorph does not show evidence of neurotoxicity. There is a subchronic neurotoxicity study available which demonstrated no neurotoxic effects in the study. In addition, neither the subchronic nor chronic toxicity studies in rats or dogs, nor the developmental toxicity studies indicated that the nervous system was affected by treatment with dimethomorph.

Specific information on the studies received and the nature of the adverse effects caused by dimethomorph 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 athttp://www.regulations.govin document “Dimethomorph: Human Health Risk Assessment to Support Amended Use on Grapes, Bulb Vegetables, LeafyBrassicaVegetables, and Leafy Vegetables,” pp. 35-38 in docket ID number EPA-HQ-OPP-2011-0388.

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, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.

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

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to dimethomorph, EPA considered exposure under the petitioned-for tolerances as well as all existing dimethomorph tolerances in 40 CFR 180.493. EPA assessed dietary exposures from dimethomorph 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 toxic effects attributable to a single dose were observed in the toxicological studies for dimethomorph; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii.Chronic exposure.In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT). Dietary Evaluation Exposure Model (DEEM) default processing factors were used.

iii.Cancer.Based on the data summarized in Unit III.A., dimethomorph has been classified as “not likely” to be a human carcinogen. EPA has concluded that dimethomorph does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and PCT information.EPA did not use anticipated residue and/or PCT information in the dietary assessment for dimethomorph. Tolerance level residues and/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 dimethomorph in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of dimethomorph. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found athttp://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 dimethomorph for acute exposures are estimated to be 81.1 parts per billion (ppb) for surface water and 0.264 ppb for ground water.

For chronic exposures for non-cancer assessments are estimated to be 24.7 ppb for surface water and 0.264 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 24.7 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). Dimethomorph is not registered for any specific use patterns that would result in residential exposure.

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

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

1.In general.Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (FQPA) Safety Factor (SF). In applying thisprovision, 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 available data did not provide evidence of any increased susceptibility in the offspring in either of the two developmental toxicity studies or in the 2-generation reproduction study. In either of these two studies toxicity was not seen in the offspring occurring at doses lower than in the parent in any of the studies. Additionally, the effects seen in the young were qualitatively similar to those in the parents.

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 dimethomorph is complete.

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

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

iv. There are no residual uncertainties identified in the exposure databases. The unrefined chronic dietary risk assessment used tolerance level residues, included modeled drinking water estimates, assumed 100 PCT, and incorporated DEEM default processing factors. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to dimethomorph in drinking water. These assessments will not underestimate the exposure and risks posed by dimethomorph.

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

1.Acute risk.An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, dimethomorph 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 dimethomorph from food and water will utilize 27% of the cPAD for children 1-2 years old the population group receiving the greatest exposure. There are no residential uses for dimethomorph and thus residential exposure to residues of dimethomorph 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). Dimethomorph is not registered for any use patterns that would result in residential exposure. Therefore, the short-term aggregate risk is the sum of the risk from exposure to dimethomorph through food and water and will not be greater than the chronic aggregate 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). Dimethomorph is not registered for any use patterns that would result in intermediate-term residential exposure. Therefore, the intermediate-term aggregate risk is the sum of the risk from exposure to dimethomorph through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk.

5.Aggregate cancer risk for U.S. population.Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, dimethomorph 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 dimethomorph residues.

FAMS-002-04 which utilizes high pressure liquid chromatography with ultraviolet detection (HPLC/UV) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: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 United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has established MRLs for dimethomorph in or on grape at 2 ppm; and grape, raisin at 5 ppm. These MRLs are different than the tolerances being established for dimethomorph in this action because the MRLs are based on residue data derived from Europe.

One comment was received from a private citizen (in reference to tolerance petition 0F7751) who encouraged the Agency to continue to reduce the risk to human health and the environment from pesticide usage. The Agency recognizes that some individuals believe that pesticide use should not be permitted. However, under the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA), EPA is authorized to establish pesticide tolerances or exemptions where persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by the statute.

The crop group regulations (40 CFR 180.41) were recently amended pertaining to Crop Group 3—Bulb Vegetables, and the revised Crop group is designated Crop group 3-07 Bulb Vegetable. The revised crop group now contains two subgroups: Bulb, subgroup3-07A and onion, green, subgroup 3-07B. Because BASF proposed to modify its existing Crop Group 3 tolerance by adding a revised green onion tolerance, EPA has determined it is appropriate to establish both onion, bulb subgroup 3-07A and onion, green, subgroup 3-07B tolerances rather than a Crop Group 3 tolerance and a green onion tolerance. Based on analysis of residue levels from crop field trail data and tolerance calculation procedures, EPA is setting the onion, bulb subgroup 3-07A tolerance at 0.6 ppm and the onion, green, subgroup 3-07B tolerance at 15 ppm. EPA is removing the existing Crop Group 3 tolerance.

Additionally, based on analysis of residue levels from crop field trail data and tolerance calculation procedures, EPA is raising tolerance levels for grape, raisin; brassica, head and stem, subgroup 5A; brassica, leafy greens, subgroup 5B; and vegetable, leafy, except brassica, group 4. For the same reason, EPA is lowering the tolerance for grape. Additionally, because the Agency is amending the BASF registration to allow use on grapes in the U.S., EPA is removing the footnote in the tolerance stating that such a registration does not exist.

Subsequent to the filing of the petition, the petitioner requested that the Agency establish tolerances in cereal grain commodities (forage, hay and straw) that are rotated to fields following use dimethomorph on commodities covered by the tolerances established in this action. The Agency determined that rotated crop tolerances would be appropriate for wheat, forage; wheat, hay; and wheat, straw.

Therefore, amended tolerances are established for residues of dimethomorph, in or on brassica, head and stem, subgroup 5A at 6.0 ppm; brassica, leafy greens, subgroup 5B at 30.0 ppm; onion, bulb subgroup 3-07A at 0.6 ppm; onion, green, subgroup 3-07B at 15.0 ppm; grape at 3.0 ppm; and grape, raisin at 7.0 ppm. A tolerance is established for residues of dimethomorph, in or on vegetable, leafy except brassica, group 4 at 30.0 ppm. This regulation also establishes tolerances for the indirect or inadvertent residues of dimethomorph, in or on wheat, forage at 0.15 ppm; wheat hay at 0.15 ppm and wheat, straw at 0.4 ppm. Furthermore, this regulation removes established tolerances on vegetable, bulb, group 3 and footnote pertaining the lack of a registration for use on grapes.

This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this 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. 3501et seq.,nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et 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 FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this 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) (Pub. L. 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. 801et 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 theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. 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 underFOR 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 athttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2009-0677 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 3, 2012. 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-2009-0677, by one of the following methods:

•Federal eRulemaking Portal: http://www.regulations.gov.Follow the online 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 theFederal Registerof July 20, 2011 (76 FR 43236) (FRL-8880-1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP #1F7871) by Arysta LifeScience North America, LLC, 15401 Weston Parkway, Suite 150, Cary, NC 27513. The petition requested that 40 CFR 180.609 be amended by revising tolerances for residues of the fungicide fluoxastrobin in or on peanut and peanut oil, from 0.01 and 0.03 to 0.02 and 0.06 parts per million (ppm) respectively. That notice referenced a summary of the petition prepared by Arysta LifeScinece North America, LLC, 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 corrected the commodity definition for peanut oil. The reason for this change is explained in Unit IV.C.

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

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for fluoxastrobin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fluoxastrobin 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. The most recent human health risk assessment for fluoxastrobin was conducted for use on the squash/cucumber crop subgroup 9B. Since that time, no new toxicology data have been submitted to the Agency and the hazard characterization and toxicity endpoints for risk assessment remain unchanged. Specific information on the studies received and the nature of the adverse effects caused by fluoxastrobin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule that established a tolerance for residues of fluoxastrobin in or on squash/cucumber subgroup 9B. This rule was published in theFederal Registerof August 17, 2011 (76 FR 50893) (FRL-8884-4).

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, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for fluoxastrobin used for human risk assessment is shown in Table 1 of the final rule published in theFederal Registerof August 17, 2011.

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to fluoxastrobin, EPA considered exposure under the petitioned-for tolerances as well as all existing fluoxastrobin tolerances in 40 CFR 180.609. EPA assessed dietary exposures from fluoxastrobin 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 fluoxastrobin; 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 Continuing Survey of Food Intake by Individuals (CSFII). As to residue levels in food, EPA conducted a conservative dietary exposure assessment for fluoxastrobin. The assumptions of this dietary assessment included tolerance level residues and 100 percent crop treated (PCT).

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

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

2.Dietary exposure from drinking water.Based on laboratory studies, fluoxastrobin persists in soils for several months to several years and is slightly to moderately mobile in soil.

The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for fluoxastrobin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fluoxastrobin. Further informationregarding EPA drinking water models used in pesticide exposure assessment can be found athttp://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 fluoxastrobin for chronic exposures for non-cancer assessments are estimated to be 52.9 parts per billion (ppb) for surface water and 0.23 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 53 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). Fluoxastrobin is currently registered for the following uses that could result in residential exposures: Spot treatment and/or broadcast control of diseases on turf, including lawns and golf courses. EPA assessed residential exposure using the following assumptions: Because of the potential for application four times per year, exposure duration is expected to be short-term and intermediate-term. A short-term dermal endpoint was not identified; therefore, only intermediate-term dermal risks as well as short- and intermediate-term inhalation risks were assessed. Homeowner residential applicators are expected to be adults.

There is also the potential for homeowners and their families (of varying ages) to be exposed as a result of entering areas that have previously been treated with fluoxastrobin. Exposure might occur on areas such as lawns used by children or recreational areas such as golf courses used by adults and youths. Potential routes of exposure include dermal (adults and children) and incidental oral ingestion (children). Since no acute hazard has been identified, an assessment of episodic granular ingestion was not conducted. While it is assumed that most residential use will result in short-term (1 to 30 days) post-application exposures, it is believed that intermediate-term exposures (greater than 30 days up to 180 days) are also possible. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at:http://www.epa.gov/pesticides/science/residential-exposure-sop.html.

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

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

2.Prenatal and postnatal sensitivity.The database for evaluatingin uteroor postnatal susceptibility includes developmental toxicity studies in both rats and rabbits and a 2-generation reproduction study in the rat. The data provide no indication of increased susceptibility of rats or rabbits to prenatal and postnatal exposure to fluoxastrobin.

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 fluoxastrobin is complete with the exception of an acceptable functional immunotoxicity study. The Agency does have an immunotoxicity study for fluoxastrobin but it has deficiencies that make it unacceptable at this time. The study may be acceptable if additional information is submitted. Nonetheless, the Agency does not believe that conducting a new immunotoxicity study will result in a lower NOAEL than the regulatory dose for risk assessment. First, the available data do not indicate that fluoxastrobin results in primary immune system effects; a NOAEL for decreased spleen weight in the absence of histopathological findings (male rats) was 53 milligrams/kilogram/day (mg/kg/day). In addition, there was no indication of a functional effect on the immune system in the unacceptable mouse immunotoxicity study at doses as high as 2,383 mg/kg/day. Finally, the registrant recently submitted a new immunotoxicity study. The Agency has not fully reviewed the study at this time, but a preliminary screen indicates that fluoxastrobin does not appear to significantly affect the immune system and would not provide a Point of Departure lower than that currently used for risk assessment. For all of these reasons, the Agency therefore believes that no additional safety factor is needed to account for the deficiencies in the first immunotoxicity study.

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

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

iv. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to fluoxastrobin in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by fluoxastrobin.

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

1.Acute risk.An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, fluoxastrobin 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 fluoxastrobin from food and water will utilize 47% 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 fluoxastrobin is not expected.

3.Short- and intermediate-term risk.Short- and intermediate-term aggregate exposure take into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Fluoxastrobin is currently registered for uses that could result in both short- and intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short- and intermediate-term residential exposures of adults and children to fluoxastrobin. Because all short- and intermediate-term quantitative hazard assessments (via the dermal and incidental oral routes) for fluoxastrobin are based on the same endpoint, a screening-level, conservative aggregate risk assessment was conducted that combined the short-term incidental oral and intermediate-term exposure estimates (i.e., the highest exposure estimates) in the risk assessments for adults. The Agency believes that most residential exposure will be short-term, based on the use pattern.

There is potential short- and intermediate-term exposure to fluoxastrobin via the dietary (which is considered background exposure) and residential (which is considered primary) pathways. For adults, these pathways lead to exposure via the oral (background), and dermal and inhalation (primary) routes. For children, these pathways lead to exposure via the oral (background), and incidental oral and dermal (primary) routes.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short- and intermediate-term food, water, and residential exposures result in aggregate MOEs of 630 for adults; 170 for children (1-2 years old). Because EPA's level of concern for fluoxastrobin is a MOE of 100 or below, these MOEs are not of concern.

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

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

Adequate enforcement methodology (liquid chromatography/mass spectrometry/mass spectrometry) is available to enforce the tolerance expression. Method No. 00604 is available for plant commodities and Method No. 00691 is available for animal commodities. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex 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 established Mexican, Canadian, or Codex MRLs or tolerances for fluoxastrobin in/on peanuts.

The proposed commodity term has been revised to agree with the Agency's Food and Feed Commodity Vocabulary. The petitioned for commodities were peanut and peanut oil. The correct commodity definitions are peanut and peanut, refined oil.

Therefore, tolerances are established for residues of fluoxastrobin, in or on peanut and peanut, refined oil at s 0.02 and 0.06 ppm respectively.

This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this 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. 3501et seq.,nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et 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 provisionsof FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this 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) (Pub. L. 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. 801et 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 theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

For its drug testing regulation, the Department of Transportation (DOT) is required by the Omnibus Transportation Employee Testing Act of 1991 (Omnibus Act) to incorporate the laboratory testing protocols and standards established by the U.S. Department of Health and Human Services (HHS). The Omnibus Act requires that we utilize HHS-certified laboratories and that we follow the HHS Mandatory Guidelines for identifying the specific drugs for which we test and the scientific methodologies the laboratories must use for testing. Because of these requirements and to create consistency with certain aspects of the new HHS Mandatory Guidelines effective October 1, 2010 [73 FR 71858], the DOT published its final rule on August 16, 2010 [75 FR 49850], also effective October 1, 2010, to harmonize with many aspects of the revised Mandatory Guidelines.

One item with which the DOT harmonized was the laboratory testing for 6-acetylmorphine (6-AM) without a morphine marker. 6-AM is a unique metabolite produced when a person uses the illicit drug heroin. Prior to the October 1, 2010 rulemaking, both HHS and DOT regulations required the laboratory to first test for morphine, and if it detected morphine at the HHS/DOT cutoff of 2000ng/mL, the lab would then test for 6-AM.

In our final rule, we discussed the concern some commentors had about whether morphine needed to be present with a confirmed positive 6-AM result. We discussed the data and studies submitted to the docket addressing the question of whether there was research or studies showing that morphine must also be present and at what quantitations. As stated at 75 FR 49856, based on the comments to the docket and multiple scientific publications, the facts were:

• 6-AM confirmed positive tests do not need a morphine marker;

• Data showed that when one looks for morphine as a marker, it most always exists above the morphine confirmation cutoffs or above Limit of Detection (LOD); and

• If the morphine marker does not exist on a 6-AM positive result, there is ample scientific reason to strongly suggest recent heroin use.

We decided that, until more experience was gained with the new testing procedures for 6-AM, we would place additional requirements on the laboratories and the MROs. Specifically, when morphine was not detected at the HHS/DOT cutoff of 2000ng/mL, we added a requirement for the laboratory and MRO to determine whether morphine was detected at the laboratory's LOD. If morphine was not detected at the laboratory's LOD, the laboratory and MRO were to report that result to DOT's Office of Drug and Alcohol Policy and Compliance (ODAPC). After consulting with ODAPC, the MRO would make a verified result determination, keeping in mind that there is no legitimate explanation for 6-AM in the employee's specimen [see § 40.151(g)].

From the October 1, 2010 effective date of the final rule through September 30, 2011, ODAPC has received, on average, 14 results per month from the laboratories and MROs that a specimen was positive for 6-AM with no morphine at the laboratory's LOD. During this period, we learned that the laboratory LODs ranged from 100ng/mL to 600ng/mL, and were set in accordance with National Laboratory Certification Program guidance to them.

As part of our monitoring process and with the varying LODs in mind, DOT worked with HHS to have their contractor, RTI International (RTI), conduct a study of those DOT specimens reported to ODAPC as confirmed positive for 6-AM and negative for morphine. The scope of the study was “* * * to verify the atypical results obtained by the laboratories, to determine if other drugs or metabolites present in the specimen could explain the absence of morphine, and to determine if something other than heroin use could explain the presence of 6-AM.”1 The study consisted of aliquots (from the A bottles) of DOT specimens received by the laboratories between October and December 2010 and reported by the laboratory to the MRO as confirmed positive for 6-AM and negative for morphine.

The study reconfirmed the presence of 6-AM in all the specimens. By reconfirming the 6-AM results, the study confirmed “* * * that the presence of 6-AM in these specimens was not due to laboratory contamination or 6-AM production during analysis.” Morphine levels of >5ng/mL were also detected in all but 6 of the specimens. For these 6 specimens, the report went on to say that, “While atypical for heroin exposure and metabolism, the remaining 6 specimens' results are consistent with literature reports of atypical 6-AM results after heroin exposure.” The authors determined that other drugs or metabolites present in the specimen were not responsible for the absence of morphine. Furthermore, the study concluded, “There was no evidence indicating that the 6-AM originated from a source other than heroin.”2

Based upon these facts and research-based conclusions, there is no longer a need for laboratories to detect the present of morphine below the HHS/DOT established morphine cutoff of 2000ng/mL and for MROs to confer with ODAPC on verifying these 6-AM results. Based on the RTI study, morphine may be present below the laboratory's LOD. As we indicated in the preamble of the final rule [75 FR 49856], for those specimens where morphine was not present we believe there is a scientific explanation. Therefore, we will amend 49 CFR 40.87 and 40.97 to say that if the laboratory confirms a specimen as positive for 6-AM, and morphine is not at or above the 2000ng/mL cutoff, the laboratory will report the specimen results to the MRO without any additional testing for morphine. We will also revise 49 CFR 40.139 and remove section 40.140. Furthermore, the MRO will conduct the verification as he or she would for any other laboratory confirmed positive test result, with the understanding there is no legitimate explanation for the presence of 6-AM in the employee's specimen regardless of the morphine result.

The statutory authority for this rule derives from the Omnibus Transportation Employee Testing Act of 1991 (49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 54101et seq.) and the Department of Transportation Act (49 U.S.C. 322).

The Department has determined this rule may be issued without a prior opportunity for notice and comment because providing prior notice and comment would be unnecessary, impracticable, or contrary to the public interest since this rule was thoroughly discussed in a prior final rule effective October 1, 2010 [75 FR 49850]. This rule will reduce the burden on laboratories and MROs since it will remove certain provisions of the drug testing regulation which currently require the laboratories and MROs to confer with each other and ODAPC regarding laboratory tests positive for 6-AM with no morphine at the laboratory's LOD. It will also remove requirements for further laboratory testing where 6-AM is detected without the presence of morphine.

Providing an opportunity for prior notice and comment before publishing this interim final rule (IFR) would be unnecessary since it is based upon a final rule [75 FR 49850, August 16, 2010] that followed public notice and comment. In that rule we indicated we would determine what our first year of testing would reveal regarding the screening and confirmation testing of 6-AM and the presence of morphine. The first year has passed and from the information provided by the laboratories and MROs, and the collaborative scientific study with HHS, we learned morphine may be present below the laboratory's LOD. In addition, for those few specimens where morphine was not present the study stated that such results were consistent with literature reports of atypical 6-AM results after heroin use.

Providing an opportunity for notice and comment before publishing this IFR is also unnecessary since it makes only minor procedural and burden-relieving amendments to the rule text. Specifically, the rule will no longer require laboratories and MROs to consult with one another regarding the testing for the presence of morphine when the laboratory confirms thepresence of 6-AM. In addition, laboratories and MROs will no longer be required to notify ODAPC of 6-AM only positive results.

This Interim Final Rule is not significant for purposes of Executive Order 12866 or the DOT's regulatory policies and procedures. The rule makes minor procedural amendments to its rule text. The rule will impose no new burdens on any parties, and will actually decrease the burden upon the laboratories and the MROs. The Department consequently certifies, under the Regulatory Flexibility Act, that this rule does not have a significant economic impact on a substantial number of small entities.

For reasons discussed in the preamble, the Department of Transportation amends Title 49 of the Code of Federal Regulations, Part 40, as follows: