Need for Correction

The Grain Inspection, Packers and Stockyards Administration published two documents in the Federal Register on January 20, 2011 (76 FR 3485) and on April 4, 2011 (76 FR 18348), concerning required scale tests. Those documents incorrectly defined limited seasonal basis in § 201.72(a) (9 CFR 201.72(a)). This document corrects § 201.72 by revising the last sentence of paragraph (a).

Accordingly, 9 CFR part 201 is corrected by making the following correcting amendment:

We received a report of an M7 Aerospace LP Model SA226-T airplane experiencing loss of rudder control during single-engine occurrence training requiring applied full rudder to compensate for yaw effect. The airplane made an uneventful landing. A visual inspection found the left-hand primary rudder control cable had failed where the cable makes a 30 degree angle over a small pulley to accommodate re-routing of the control cable alongside the camera system installed in the center of the cabin.

AD 87-02-02 (52 FR 2511, January 23, 1987) requires periodic inspection or replacement of all flight control cables on Models SA226 and SA227 airplanes. This new AD action requires repetitive replacement of specific flight control cables on affected serial number Model SA226 airplanes that have been modified by installation of a camera system requiring rerouting of the affected flight control cables.

This condition, if not corrected, could result in loss of controlled flight due to failure of a rudder, aileron and/or elevator control cable.

We reviewed M7 Aerospace LP Service Bulletin 226-27-072, dated June 27, 2011. The service information describes procedures for repetitive inspection and replacement of all elevator, rudder, aileron, and aileron-to-rudder interconnect primary control cables.

We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of these same type designs.

This AD requires accomplishing the actions specified in the service information described previously.

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because if an elevator cable or another cable in certain situations breaks, the outcome can be catastrophic. Therefore, we find that notice and opportunity for prior public comment are impracticable and that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2011-0832; Directorate Identifier 2011-CE-025-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD.

We estimate that this AD affects 4 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

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

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

For the reasons discussed above, I certify that this AD:

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

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

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

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

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

Background

On March 16, 2010, U.S. Customs and Border Protection (“CBP”) published a proposed rule in the Federal Register (75 FR 12483) proposing to amend title 19 of the Code of Federal Regulations (“19 CFR”) to discontinue mailing paper courtesy notices to importers of record whose entry summaries are filed in the Automated Broker Interface (“ABI”). The proposed amendments were intended to streamline the notification process and reduce printing and mailing costs, as provided in the proposed rule. See 75 FR 12483.

While CBP is not statutorily required to provide advance notice of the liquidation date to the importer or his agent, CBP does issue informal, courtesy notices of liquidation (hereinafter “courtesy notice” or “courtesy notices”). See 19 CFR 159.9(d).

Currently, CBP issues electronic courtesy notices to all ABI filers: importers of record who file their own entries and customs brokers who file as the duly authorized agents of the importer of record. CBP's Technology Center also mails paper courtesy notices, on CBP Form 4333-A, to all importers of record whose entry summaries are scheduled to liquidate by each port of entry. As a result, two courtesy notices are issued for importers of record whose electronic entry summaries are filed in ABI: An electronic courtesy notice to the ABI filer, that is either the importer of record or a customs broker filing on behalf of the importer of record, and a paper courtesy notice to the importer of record. Therefore, this renders duplicative the paper courtesy notice sent by CBP to importers of record that file their own entries in ABI because, as an ABI filer, they already receive an electronic courtesy notice. See 19 CFR part 143.

Under the proposed rule, when electronic entry summaries are filed in ABI, ABI filers would only receive electronic courtesy notices; paper courtesy notices would not also be sent to importers of record that do not file their own entries. Importers of record filing a paper formal entry with CBP would continue to receive a mailed courtesy notice. See 19 CFR parts 141 and 142. In addition, all importers of record with an Automated Commercial Environment (“ACE”) Secure Data Portal Account can monitor the liquidation of their entries by using the reporting tool in the ACE Secure Data Portal Account.

The following analysis details the cost savings that would be realized by the agency as a result of eliminating paper courtesy notices to importers of record who personally receive an electronic courtesy notice or whose broker receives an electronic courtesy notice on their behalf. In FY 2009, CBP sent approximately 7.2 million paper courtesy notices. Under this rule, CBP estimates that over 90 percent of paper courtesy notices will be eliminated. For the purpose of this analysis, we assume 6.5 million paper notices (90 percent) will be eliminated. Additionally, we assume that the number of notices does not change from year to year.

By decreasing the number of paper courtesy notices distributed, CBP will significantly reduce postage costs required to mail the notices. Current U.S. Postal Service first-class letter rates are 44 cents within the United States, 75 cents to Canada, 79 cents to Mexico, and 98 cents to the rest of the world. Exhibit 1 shows the total estimated savings on postage in 2010, an estimated $3 million.

CBP estimates that each courtesy notice form costs $0.027. Decreasing the number of paper forms by 6.5 million will save the agency approximately $175,599 per year.

CBP estimates the cost of contractors employed to print the paper courtesy notices is $0.08 per copy. Based on this estimate, the cost savings on labor for printing is approximately $520,294 per year.

Exhibit 2 displays all of the cost savings that have been quantified for this analysis.

We total these savings over the next 10 years at a 3 and 7 percent discount rate, per guidance provided in the OMB's Circular A-4. Total estimated savings range from $28.4 million to $33.3 million over the period of analysis. Annualized savings are $3.8 million. Total present value and annualized savings are presented in Exhibit 3.

CBP has service contracts with fixed monthly costs for the equipment used to print and mail the paper courtesy notices. Current maintenance costs are approximately $45,048 per year for two printers and approximately $3,478 per year for a finishing machine. CBP is exploring lower cost options to replace these machines, but we are unable to quantify these savings or predict when they might occur. Additional costs associated with the printing and distribution of paper courtesy notices include labor by government employees on the CBP Mail Management Team and mainframe processing time. Reducing the number of paper notices will allow both Mail Management Team and mainframe resources to be used for other purposes. While we do not have enough data to quantify these savings at this time, they are important to consider in the analysis of the total impact of the reduction of paper courtesy notices.

CBP estimates that this rule will save the agency $3.8 million annually by eliminating 90 percent, or approximately 6.5 million, of the paper courtesy notices currently sent to importers. If more than 90 percent are eliminated, savings could be higher. Quantified savings include reduced postage, forms, and contract labor costs. Additional savings may be realized by reducing maintenance costs on equipment used to produce the paper notices and allowing more efficient use of other government resources.

CBP solicited public comments on the proposed rule.

Eight commenters responded to the solicitation of public comments in the proposed rule. Several of these commenters applauded CBP's effort to achieve cost savings by eliminating the mailing of paper. However, three commenters objected to CBP entirely eliminating the paper courtesy notice for ABI filers for several reasons discussed below, and four commenters requested that the courtesy mailing continue until CBP develops an alternative means of notifying importers of the liquidation of their entries.

Several commenters stated that the proposal will make importers of record reliant upon their brokers for liquidation information. Importers stated that they use the liquidation information on the courtesy notices to: monitor their entries for fraudulent activities; determine liquidation dates, protest deadlines, and contingent liability periods; check for errors; and track the status of antidumping and countervailing duty entries.

Without the courtesy notice, importers who are ABI filers state that they would need to contact their brokers for the liquidation information. However, a commenter noted that many importers utilize more than one customs broker to make their entries, and sometimes, the importer's broker will use outport brokers (those from other customs broker districts) to make entry on behalf of the importer for whom they have a power of attorney.

Moreover, it was noted that brokers sometimes fail to provide importers with timely notification of liquidation information. When such instances occur, the broker's liability is limited to $50, whereas importers may lose their ability to challenge a CBP decision, thereby potentially resulting in a loss of millions of dollars.

Pursuant to 19 CFR 111.39, “[a] broker must not withhold information relative to any customs business from a client who is entitled to that information.” Liquidation information is information related to “customs business”; therefore, brokers cannot withhold this information from their importer clients.

In addition, ACE is being reprogrammed to allow all importers of record to monitor liquidation of entries filed under their importer of record number(s) through the ACE Portal. Importers can establish an ACE Portal Account to access reports that will help them monitor entry filings for potential fraudulent entries and access liquidation dates for entries filed by any filer using the importer of record number belonging to the importer, regardless of the filer code used.

Furthermore, whether or not the importer has an ACE Portal Account, the importer may gain limited access to a broker's ACE Portal Account to obtain reports for entries filed by the broker using the importer of record number belonging to that importer, if the broker that filed the entry grants the importer such access.

Given data storage limitations, at this time, the ACE Portal only contains entry data for entries filed in the current CBP fiscal year and the previous four CBP fiscal years. (The CBP fiscal year runs from October 1 through September 30.) Importers needing liquidation dates for entries filed beyond that time period may contact their broker, who can obtain that information by running an ABI query. As for antidumping and countervailing duty entries, depending on the entry date, importers may be able to check their status via a report in the ACE Portal. Please note that contractual terms of liability between importers and brokers are not controlled by CBP.

Additional information on the ACE Portal capabilities and instructions for applying for access to the ACE Portal, which is accessible free of charge, are available on the following Web site: http://www.cbp.gov/xp/cgov/trade/automated/modernization/ace_app_info/.

The instructions for managing ACE Portal user accounts are available on the following Web site: http://www.cbp.gov/xp/cgov/trade/automated/modernization/ace_welcome/ace_welcome_package/.

One commentator was concerned about the accessibility of liquidation information entered with a filer code that subsequently became inactive at the time of liquidation.

Even if the filer code is no longer active, the importer will be able to access the liquidation date associated with the importer's importer of record number using the reporting tool in the ACE Portal.

Several commenters suggested alternatives to CBP's proposal, such as: creating a system for importers to obtain the liquidation information that is available on the courtesy notices; sending courtesy notifications via e-mail; surveying importers who file their entries via ABI to determine whether they wish to discontinue receiving mailed courtesy notices allowing importers to opt out of receiving paper courtesy notices at the time CBP assigns an importer of record number for importers, or notifying the importers at that time that that they will have either to rely upon ABI for liquidation information or participate in ACE; ensuring that the information listed in ACE is accurate, particularly the data regarding older entries; and developing an electronic bulletin notice of liquidation.

Also, several commenters suggested delaying implementation of the proposal until ACE becomes capable of issuing complete liquidation reports and/or until all entry filers begin using ACE.

On the effective date of this document, through the ACE Portal reporting mechanism, CBP will be able to make available complete liquidation reports to importers with ACE accounts, including liquidation dates for all entries. Furthermore, an e-mail courtesy notification of liquidation would just duplicate this information.

CBP does not plan on surveying the trade community to determine which ABI-filing importers wish to discontinue receiving mailed courtesy notices, which CBP believes would not garner further substantial input. CBP agrees that training will help importers transition into using the ACE system. Currently, CBP provides Web-based training for new ACE Account holders, and help desk support to aid with account access, account management, and report generation in the ACE Portal. Please see the following Web site for further information: https://nemo.customs.gov/ace_online/.

Although this training resource and the ACE Portal are already available and functional, importers will have until September 17, 2011 to enroll in the ACE Portal Account and familiarize themselves with the reporting system.

Moreover, CBP has considered the option of posting an electronic bulletin notice of liquidation and will continue to explore the feasibility of that option. Courtesy notices of liquidations, rather than the statutorily mandated bulletin notice of liquidation, are the focus of this rulemaking. Accordingly, this suggestion is outside the scope of this rulemaking.

The purpose of this proposal is to reduce printing and mailing costs by eliminating duplicative notice to importers that file their entries via ABI. Therefore, CBP does not intend to provide importers with the option of receiving paper courtesy notices or opting out of receiving paper courtesy notices.

Regarding the suggestion that CBP should ensure that the information in ACE is accurate, particularly regarding older entries, CBP agrees that maintaining accurate data in any system of record is of paramount concern. As discussed above, the entry data in the ACE Portal is confined to the current CBP fiscal year and the previous four CBP fiscal years because of data storage limitations. ABI filers may run an ABI query for liquidation dates for entries filed beyond that time period. Please note that for a historical report on all of an importer's importation activity over a set time period, an importer can file a request with CBP for an ITRAC (Importer Trade Activity) report for a fee, see http://www.cbp.gov/xp/cgov/admin/fl/foia/itrac/itrac.xml. If one is a C-TPAT member, this report is provided free of cost.

Finally, the ACE report contains the same data elements as the paper courtesy notice, with the exception of: (1) Importer address; (2) series; (3) refer inquiries to; and (4) liquidation code. The “importer address” data element will not appear in the ACE Portal report because the report will not be mailed. The “series” data element will not appear because it has not been used since 1986 when the entry format configuration was changed to eliminate the series, that is, the “2-digit Fiscal Year” code which appeared in the 5th and 6th place of the entry number format. The “refer inquiries to” data element will not appear in the ACE Portal report; however, the report will provide the name and code for the port of entry. Importers can refer any inquiries to the appropriate port of entry using the following Web site: http://www.cbp.gov/xp/cgov/toolbox/contacts/ports/. Finally, the “liquidation code” data element is an internal CBP-assigned code used for managing various liquidation types and will not appear in the report.

One commenter indicated that courtesy notices deemed undeliverable by the U.S. Postal Service help the Revenue Division update its importer address database.

The Revenue Division now relies on the importer to keep its address and contact information current with CBP.

After review of the comments and further consideration, CBP has decided to adopt the proposed rule published in the Federal Register (75 FR 12483) on March 16, 2010, without substantive change. Accordingly, the effective date will be September 30, 2011. The implementation date will be the first day on or after September 30, 2011, that CBP can provide importers with complete liquidation reports, including liquidation dates, electronically through the ACE Portal. CBP will confirm implementation through electronic notification (see http://www.cbp.gov ).

This final rule is not a “significant regulatory action” per Executive Order 12866 because it will not result in savings or expenditures totaling $100 million or more in any one year. The Office of Management and Budget (“OMB”) has not reviewed this regulation under that order. The final rule will result in cost savings as discussed earlier in the preamble.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) requires Federal agencies to examine the impact a rule would have on small entities. A small entity may be a small business (defined as any independently owned and operated business not dominant in its field that qualifies as a small business per the Small Business Act); a small not-for-profit organization; or a small governmental jurisdiction (locality with fewer than 50,000 people).

This final rule will eliminate paper courtesy notices that are sent to importers who file entry summaries via ABI or who hire a third party to file via ABI on their behalf. The primary impact of this final rule will be the savings realized by CBP as a result of eliminating a large portion of its annual printing and mailing costs associated with paper courtesy notices. Those importers that do not file using ABI will continue to receive paper courtesy notices. Those importers that file via ABI themselves will not be significantly impacted because they will continue to receive an electronic notification. Those importers that hire a broker to file via ABI on their behalf (with the broker filing as an agent and not an importer of record) will now have to obtain the notification from their broker or view the information via CBP's ACE Portal. To the extent that brokers send the notification to the importer, they will bear a small cost, but because of the low cost of forwarding this information either electronically or by mail, this cost does not rise to the level of significance. CBP solicited comments on the economic impact of this rule on small entities in the Notice of Proposed Rulemaking, but did not receive any of substance. For these reasons, CBP certifies that this final rule will not have a significant economic impact on a substantial number of small entities.

As there is no collection of information in this document, the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) are inapplicable.

This document is being issued in accordance with 19 CFR 0.1(a)(1) pertaining to the Secretary of the Treasury's authority (or that of his delegate) to approve regulations related to certain customs revenue functions.

For the reasons set forth in the preamble, part 159 of title 19 of the CFR (19 CFR part 159) is amended as set forth below.

This document contains final amendments to the Income Tax Regulations (26 CFR part 1) under sections 195, 248, and 709 of the Internal Revenue Code to reflect amendments made by section 902 of the American Jobs Creation Act of 2004 (Pub. L. 108-357, 118 Stat. 1418) (the Act). The amendments made by section 902 of the Act are effective for amounts paid or incurred after October 22, 2004, the date of the enactment of the Act.

As amended by section 902(a) of the Act, section 195(b) allows an electing taxpayer to deduct, in the taxable year in which the taxpayer begins an active trade or business, an amount equal to the lesser of (1) the amount of the start-up expenditures that relate to the active trade or business, or (2) $5,000, reduced (but not below zero) by the amount by which the start-up expenditures exceed $50,000. The remainder of the start-up expenditures is deductible ratably over the 180-month period beginning with the month in which the active trade or business begins.

As amended by section 902(b) of the Act, section 248(a) allows an electing corporation to deduct, in the taxable year in which the corporation begins business, an amount equal to the lesser of (1) the amount of the organizational expenditures of the corporation, or (2) $5,000, reduced (but not below zero) by the amount by which the organizational expenditures exceed $50,000. The remainder of the organizational expenditures is deductible ratably over the 180-month period beginning with the month in which the corporation begins business.

As amended by section 902(c) of the Act, section 709(b) allows an electing partnership to deduct, in the taxable year in which the partnership begins business, an amount equal to the lesser of (1) the amount of the organizational expenses of the partnership, or (2) $5,000, reduced (but not below zero) by the amount by which the organizational expenses exceed $50,000. The remainder of the organizational expenses is deductible ratably over the 180-month period beginning with the month in which the partnership begins business.

On July 8, 2008, temporary regulations (TD 9411) regarding elections to deduct start-up and organizational expenditures under sections 195, 248, and 709 were published in the Federal Register (73 FR 38910). A notice of proposed rulemaking (REG-164965-04) cross-referencing the temporary regulations was published in the Federal Register (73 FR 38940) on the same day. One written comment responding to the notice of proposed rulemaking was received. No public hearing was requested or held. After consideration of the comment, the regulations are adopted as amended by this Treasury decision. The comment is discussed elsewhere in this preamble.

These regulations apply to expenditures paid or incurred after August 16, 2011. However, taxpayers may apply all the provisions of these regulations to expenditures paid or incurred under sections 195, 248, and 709 after October 22, 2004, provided the period of limitations on assessment of tax has not expired for the year the election under section 195, 248, or 709 is deemed made. Expenditures paid or incurred on or before October 22, 2004, may be amortized over a period of not less than 60 months as provided for under prior law.

The commentator recommended that the final regulations clarify what is meant in the proposed regulations by “clearly electing to capitalize” start-up and organizational costs. The commentator noted that it is unclear whether a taxpayer that unintentionally does not deduct or amortize start-up and organizational costs could be considered to have “clearly elected to capitalize” them. The IRS and the Treasury Department agree with the recommendation to clarify the election requirements, and the final regulations provide that a taxpayer wishing to make an election to capitalize start-up and organizational costs must “affirmatively elect to capitalize” the costs on a timely filed Federal income tax return.

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866 as supplemented by Executive Order 13563. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. Because the regulations do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Code, the notice of proposed rulemaking preceding these final regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

The principal author of these regulations is R. Matthew Kelley of the Office of the Associate Chief Counsel (Income Tax & Accounting). However, other personnel from the IRS and Treasury Department participated in their development.

Accordingly, 26 CFR part 1 is amended as follows:

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

On October 5, 2010 (75 FR 61367), EPA proposed to approve the following rule into the California SIP.

We proposed to approve this rule because we determined that it complied with the relevant CAA requirements. Our proposed action contains more information on the rule and our evaluation.

EPA's proposed action provided a 30-day public comment period. During this period, we received comments from the following parties.

1. Dan Pourreau and Dave Roznowski, Lyondell Chemical; letter dated October 25, 2010.

2. David Darling, American Coatings Association; letter dated November 3, 2010.

The comments and our responses are summarized below.

Comment #1: Lyondell Chemical commented that, in 2009, they requested that EPA remove all reporting and recordkeeping requirements for tertiary-butyl acetate (TBAc), but has not yet received a formal response from EPA. Lyondell's comment requests that EPA respond to the 2009 request by removing the unique tracking requirement for TBAc and moving TBAc to the 40 CFR 51.100(s)(1) list of exempt compounds. Lyondell further requests that EPA remove the proposed recommendation to include a recordkeeping requirement for future Rule 1113 revisions, because this is complicating the rule development process and making TBAc a less attractive VOC-compliance option than it should be regarding Rule 1113 as well as coatings subject to other South Coast rules.

In support of these requests, Lyondell states that EPA is not using the TBAc data for modeling purposes and does not require reporting for any other exempt compound with “borderline” reactivity, that TBAc has low toxicity and negligible environmental impact, and that reporting and tracking its emissions does not help protect human health or the environment. Lyondell also states most States do not track and report TBAc emissions. Lyondell feels that tracking and reporting TBAc emissions is a new and burdensome requirement, and that Lyondell has provided and continues to provide TBAc sales data by State to the EPA, so requiring that users and the States also report emissions is redundant, an unnecessary bureaucratic burden, and fraught with error.

American Coatings Association (ACA) similarly objects to EPA's recordkeeping recommendations on the grounds that the reporting and recordkeeping requirements created in 2004 specifically for TBAc in 40 CFR 51.100(s)(5) are burdensome, arbitrary, contrary to the goals of the CAA, and should be rescinded.

Response #1: Similar comments were summarized and replied to in EPA's final action to revise treatment of TBAc in 40 CFR 51.100(s)(5) (See 69 FR 69298, November 29, 2004). The comments have not provided new information that changes EPA's previous response to these issues. In addition, we note that TBAc is only addressed in recommendations discussed in the preamble to today's action. Today's final action does not require any revisions to South Coast's treatment of TBAc.

Comment #2: ACA states it is questionable whether the Averaging Compliance Option is an Economic Incentive Program (EIP) as defined in EPA's guidance. Emissions occur during the activity of applying coatings, which is not regulated under Rule 1113. The limits of Rule 1113 apply to the VOC contents, not emissions, of coating expressed as mass of VOC per volume of coating, not activity level. ACA further comments that, given the extremely low limits of Rule 1113, additional discounting is not feasible for specific compliance, averaging compliance, or a combination of the two.

Response #2: As ACA noted, part of the regulatory approach in architectural coatings requires manufacturers to meet specified VOC standards in their products. EPA's EIP guidance applies broadly and is not limited to only direct emitters of pollution. EIP is defined as a program which may include State established measures directed toward stationary, area, and/or mobile sources, to achieve emissions reductions milestones, to attain and maintain ambient air quality standards, and/or provide more flexible, lower-cost approaches to meeting environmental goals. The Averaging Compliance Option in Rule 1113 provides manufacturers a more flexible and potentially lower cost approaches to meeting the standards. As such, Rule 1113 is an EIP. Please see page 158 of the EIP Guidance (see http://www.epa.gov/ttn/oarpg/t1/memoranda/eipfin.pdf ).

Comment #3: ACA states that a shorter averaging period is not feasible because of the complexity involved in gathering and verifying retail sales data, and making program adjustments to ensure continuous compliance.

Response #3: The recommendation was made based on the EIP guidance. However, after a review of the provision, we feel an averaging period longer than 30 days is acceptable for this rule. Therefore, we are no longer recommending the district reduce the averaging period to 30 days or less and we have communicated this to the district.

No comments were submitted that change our assessment that the submitted rules comply with the relevant CAA requirements. Therefore, as authorized in section 110(k)(3) of the Act, EPA is fully approving these rules into the California SIP.

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 17, 2011. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

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 under FOR FURTHER INFORMATION CONTACT .

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://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-2010-0725 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 October 17, 2011. 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-2010-0725, by one of the following methods:

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

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

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

In the Federal Register of September 23, 2010 (75 FR 57942) (FRL-8845-4), 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 0F7726) by Arysta LifeScience North America, LLC, 15401 Weston Pkwy., Suite 150, Cary, NC 27513. The petition requested that 40 CFR 180.609 be amended by establishing a tolerance for residues of the fungicide, fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4- pyrimydinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O- methyloxime, and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimydinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O- methyloxime, in or on raw agricultural commodities listed under crop squash/cucumber subgroup 9B at 0.50 parts per million (ppm). That notice referenced a summary of the petition prepared by Arysta LifeScience, 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 made the following changes to the proposed fluoxastrobin tolerance. A minor change has been made to the commodity name to conform to the Agency's Food and Feed Commodity Vocabulary.

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 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.

Fluoxastrobin has a low order of acute toxicity via the oral, dermal and inhalation routes of exposure. Fluoxastrobin is a moderate eye irritant but is neither a dermal irritant nor a skin sensitizer.

Fluoxastrobin appears to have mild or low toxicity following repeated administration in all tested species other than the dog. In both the 90-day and 1-year oral feeding dog studies, there was liver toxicity in the form of cholestasis as evidenced by hepatocytomegaly and cytoplasmic granular changes associated with increased liver weight and increased serum liver alkaline phosphatase (ALP). In addition, several phase I and phase II liver drug metabolizing enzymes were induced.

In the rat and rabbit developmental toxicity studies and the 2-generation reproduction rat study, there was no increased susceptibility to prenatal or postnatal exposure to fluoxastrobin and no effects on reproduction.

Fluoxastrobin is not acutely neurotoxic in rats up to a single high dose of 2,000 milligrams/kilogram/day (mg/kg/day) or by repeated dietary feeding in the rat subchronic neurotoxicity screening study where the top dose was nearly half the limit dose of 1,000 mg/kg/day. Other studies in rats including the subchronic, chronic toxicity/carcinogenicity, 2-generation reproduction, and developmental toxicity were tested to or above the limit dose with no indication of clinical signs, histopathology or other signs of toxicity that could be attributed to neurotoxicity. Also, in both the 90-day and 1-year dog studies, neurologic examinations, including mental status/behavior, gait characteristics, postural status and reactions, and spinal/cranial reflexes, were carried out and were found to be within normal limits.

Fluoxastrobin is not immunotoxic based on repeated dosing studies in rats and mice. In the 90-day oral toxicity rat study, there was no difference between the controls and treated animals in spleen cell count, macrophage activities after phorbol myristate acetate (PMA) stimulation and plaque-forming cell assay after challenge with sheep erythrocytes. Slight decreases were noted in immunoglobulin G concentration in the high dose males but not females. An unacceptable subchronic immunotoxicity study in mice found no apparent decrease on B-cell activated, T-cell mediated immunoglobulin M (IgM) response to sheep red blood cell (SRBC) at doses as high as 2,383 mg/kg/day.

Fluoxastrobin and major metabolites were negative in a battery of genotoxicity tests. The carcinogenic potential of fluoxastrobin was adequately tested in rats and mice of both sexes. The results demonstrated a lack of treatment-related increase in tumor incidence in rats or mice. There was no mutagenicity concern and no structure activity relationship alert. It was concluded that there was no incidence of carcinogenicity for fluoxastrobin.

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 published in the Federal Register of September 16, 2005 (70 FR 54640) (FRL-7719-9).

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

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

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site http://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-2011-0481 (summary docket) or the individual docket for a specific new use: EPA-HQ-OPP-2010-0041 (peanut), EPA-HQ-OPP-2010-0324 (alfalfa), or EPA-HQ-OPP-2010-0602 (food/feed commodities in food/feed handling establishments) 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 October 17, 2011. 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-2011-0481 (summary docket) or the individual docket for a specific new use: EPA-HQ-OPP-2010-0041 (peanut), EPA-HQ-OPP-2010-0324 (alfalfa), -HQ-OPP-2010-0602 (food/feed commodities in food/feed handling establishments) 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.

This final rule addresses three petitions for tolerances.

1. Peanut. In the Federal Register of March 24, 2010 (75 FR 14154) (FRL-8815-6), 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 9F7657) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.565 be amended by establishing tolerances for residues of the insecticide thiamethoxam, 3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl- N -nitro-4 H -1,3,5-oxadiazin-4-imine and its metabolite, N -(2-chloro-thiazol-5-ylmethyl)- N′ -methyl- N′ -nitro-guanidine, in or on peanut at 0.05 parts per million (ppm) and peanut hay at 0.25 ppm. That notice referenced a summary of the petition prepared by Syngenta Crop Protection, Inc., 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 determined that a tolerance must also be established for peanut meal at 0.15 ppm. The reasons for this change are explained in Unit IV.D.

2. Alfalfa. In the Federal Register of June 8, 2010 (75 FR 32463) (FRL-8827-5), 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 0F7707) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.565 be amended by establishing tolerances for residues of the insecticide thiamethoxam, 3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl- N -nitro-4 H -1,3,5-oxadiazin-4-imine and its metabolite, N -(2-chloro-thiazol-5-ylmethyl)- N′ -methyl- N′ -nitro-guanidine, in or on alfalfa, forage at 0.05 ppm and alfalfa, hay at 0.12 ppm. That notice referenced a summary of the petition prepared by Syngenta Crop Protection, Inc., the registrant, which is available in the docket, http://www.regulations.gov. One comment was received from a private citizen who opposes any pesticide that leaves a residue on food. The Agency has received this same comment from this commenter on numerous previous occasions and rejects it for reasons previously stated. 70 FR 1349, 1354 (January 7, 2005).

3. Food/feed commodities in food/feed handling establishments. In the Federal Register of June 22, 2011 (76 FR 36479) (FRL-8878-1), 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 0F7734) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.565 be amended by establishing tolerances for residues of the insecticide thiamethoxam, 3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl- N -nitro-4 H -1,3,5-oxadiazin-4-imine and its metabolite, N -(2-chloro-thiazol-5-ylmethyl)- N′ -methyl- N′ -nitro-guanidine, in or on food commodities and feed commodities (other than those covered by a higher tolerance as a result of use on growing crops) in food/feed handling establishments at 0.01 ppm. That notice referenced a summary of the petition prepared by Syngenta Crop Protection, Inc., the registrant, which is available in the docket, http://www.regulations.gov. One comment was received from a private citizen who opposes any pesticide that leaves a residue on food. The Agency has received this same comment from this commenter on numerous previous occasions and rejects it for reasons previously stated. 70 FR 1349, 1354 (January 7, 2005).

Based upon review of the data supporting the petition, EPA has determined that the tolerance for food commodities and feed commodities (other than those covered by a higher tolerance as a result of use on growing crops) in food/feed handling establishments be raised to 0.02 ppm. The reasons for this change are explained in Unit IV.D.

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

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

Thiamethoxam shows toxicological effects primarily in the liver, kidney, testes, and hematopoietic system. In addition, developmental neurological effects were observed in rats. This developmental effect is being used to assess risks associated with acute exposures to thiamethoxam, and the liver and testicular effects are the bases for assessing longer term exposures. Although thiamethoxam causes liver tumors in mice, the Agency has classified thiamethoxam as “not likely to be carcinogenic to humans” based on convincing evidence that a non-genotoxic mode of action for liver tumors was established in the mouse and that the carcinogenic effects are a result of a mode of action dependent on sufficient amounts of a hepatotoxic metabolite produced persistently. The non-cancer (chronic) assessment is sufficiently protective of the key events (perturbation of liver metabolism, hepatotoxicity/regenerative proliferation) in the animal mode of action for cancer. Refer to the Federal Register of June 22, 2007 (72 FR 34401) (FRL-8133-6) for more information regarding the cancer classification of thiamethoxam.

Thiamethoxam produces a metabolite known as CGA-322704 (referred to in the remainder of this rule as clothianidin). Clothianidin is also registered as a pesticide. While some of the toxic effects observed following testing with the thiamethoxam and clothianidin are similar, the available information indicates that thiamethoxam and clothianidin have different toxicological effects in mammals and should be assessed separately. A separate risk assessment of clothianidin has been completed in conjunction with the registration of clothianidin. The most recent assessments, which provide details regarding the toxicology of clothianidin, are available in the docket EPA-HQ-OPP-2008-0945, at http:///www.regulations.gov. Refer to the documents “Clothianidin: Human Health Risk Assessment for Proposed Uses on Berries (Group 13-07H), Brassica Vegetables (Group 5), Cotton, Cucurbit Vegetables (Group 9), Fig, Fruiting Vegetables (Group 8), Leafy Green Vegetables (Group 4A), Peach, Pomegranate, Soybean, Tree Nuts (Group 14), and Tuberous and Corm Vegetables (Group 1C)”; and “Clothianidin: Human Health Risk Assessment for Proposed Seed Treatment Uses on Root and Tuber Vegetables (Group 1), Bulb Vegetables (Group 3), Leafy Green Vegetables (Group 4A), Brassica Leafy Vegetables (Group 5), Fruiting Vegetables (Group 8), Cucurbit Vegetables (Group 9), and Cereal Grains (Group 15, except rice).”

Specific information on the studies received and the nature of the adverse effects caused by thiamethoxam 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 published in the Federal Register of June 22, 2007.

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

A summary of the toxicological endpoints for thiamethoxam used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of June 22, 2007.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to thiamethoxam, EPA considered exposure under the petitioned-for tolerances as well as all existing thiamethoxam tolerances in 40 CFR 180.565. EPA assessed dietary exposures from thiamethoxam in food as follows.

For both acute and chronic exposure assessments for thiamethoxam, EPA combined residues of clothianidin coming from thiamethoxam with residues of thiamethoxam per se. As discussed in this unit, thiamethoxam's major metabolite is CGA-322704, which is also the registered active ingredient clothianidin. Available information indicates that thiamethoxam and clothianidin have different toxicological effects in mammals and should be assessed separately; however, these exposure assessments for this action incorporated the total residue of thiamethoxam and clothianidin from use of thiamethoxam because the total residue for each commodity for which thiamethoxam has a tolerance has not been separated between thiamethoxam and its clothianidin metabolite. The combining of these residues, as was done in this assessment, results in highly conservative estimates of dietary exposure and risk. A separate assessment was done for clothianidin.

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 thiamethoxam. In estimating acute 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 of thiamethoxam and clothianidin. It was also assumed that 100% of crops with registered or requested uses of thiamethoxam and 100% of crops with registered or requested uses of clothianidin are treated.

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 and/or anticipated residues from thiamethoxam field trials. It was also assumed that 100% of crops with registered or requested uses of thiamethoxam and 100% of crops with registered or requested uses of clothianidin are treated.

A complete listing of the inputs used in these assessments can be found in the following documents: “Thiamethoxam. Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration as a Seed Treatment for Alfalfa and Peanuts, and for Use in Food Handling Establishments,” available in the dockets EPA-HQ-OPP-2009-0041, EPA-HQ-OPP-2010-0324, and EPA-HQ-OPP-2010-0602, at http://www.regulations.gov; and “Clothianidin Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments,” available in the docket EPA-HQ-OPP-2008-0771, at http://www.regulations.gov.

iii. Cancer. EPA concluded that thiamethoxam is “not likely to be carcinogenic to humans” based on convincing evidence that a non-genotoxic mode of action for liver tumors was established in the mouse, and that the carcinogenic effects are a result of a mode of action dependent on sufficient amounts of a hepatotoxic metabolite produced persistently. The non-cancer (chronic) assessment is sufficiently protective of the key events (perturbation of liver metabolism, hepatotoxicity/regenerative proliferation) in the animal mode of action for cancer and thus a separate exposure assessment pertaining to cancer risk is not necessary. Because clothianidin is not expected to pose a cancer risk, a quantitative dietary exposure assessment for the purposes of assessing cancer risk was not conducted.

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

2. Dietary exposure from drinking water. Thiamethoxam is expected to be persistent and mobile in terrestrial and aquatic environments. These fate properties suggest that thiamethoxam has a potential to move into surface water and shallow ground water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for thiamethoxam in drinking water. Because the Agency does not have comprehensive monitoring data, the Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for thiamethoxam in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of thiamethoxam. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

For surface water, the estimated drinking water concentrations (EDWCs) are based on thiamethoxam concentrations in water from rice paddies and cranberry bogs that drains into adjacent surface water bodies (often referred to as “tail water”). Because the uses on rice and cranberries involve flooding, for which Pesticide Root Zone Model/Exposure/Analysis Modeling System (PRZM/EXAMS) is not currently parameterized, these uses were assessed using the modified Tier I Rice Model and the Provisional Cranberry Model. Exposure estimates were refined with a default percent cropped area factor of 87%. The Tier I Rice Model is expected to generate conservative EDWCs that exceed peak measured concentrations of pesticides in water bodies well downstream of rice paddies by less than one order of magnitude to multiple orders of magnitude.

For ground water, the EDWCs are based on thiamethoxam concentrations resulting from use on dry bulb onions. Exposure in ground water due to leaching was assessed with the Screening Concentration in Groundwater (SCI-GROW) models.

Based on the Tier I Rice Model and SCI-GROW models, the EDWCs of thiamethoxam for acute exposures are 131.77 parts per billion (ppb) for tail water (i.e. surface water) and 4.66 ppb for ground water. The EDWCs for chronic exposures for non-cancer assessments are 11.31 ppb for tail water and 4.66 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. The most conservative EDWCs in both the acute and chronic exposure scenarios were for rice tail water, and represent worst case scenarios. Therefore, for the acute dietary risk assessments for thiamethoxam, the upper-bound EDWC value of 131.77 ppb was used to assess the contribution to drinking water. For the chronic dietary risk assessments for thiamethoxam, the upper-bound EDWC value of 11.31 ppb was used to assess the contribution to drinking water.

The registrant has conducted small-scale prospective ground water studies in several locations in the United States to investigate the mobility of thiamethoxam in a vulnerable hydrogeological setting. A review of those data show that generally, residues of thiamethoxam, as well as clothianidin, are below the limit of quantification (0.05 ppb). When quantifiable residues are found, they are sporadic and at low levels. The maximum observed residue levels from any monitoring well were 1.0 ppb for thiamethoxam and 0.73 ppb for clothianidin. These values are well below the modeled estimates summarized in this unit, indicating that the modeled estimates are, in fact, protective of what actual exposures are likely to be.

Clothianidin is not a significant degradate of thiamethoxam in surface or ground water sources of drinking water and, therefore, was not included in the EDWCs used in the thiamethoxam dietary assessments. For the clothianidin assessments, the acute EDWC value of 7.29 ppb for clothianidin was incorporated into the acute dietary assessment and the chronic EDWC value of 5.88 ppb for clothianidin was incorporated into the chronic dietary assessment.

A complete listing of the inputs used in these assessments can be found in the following documents: “Thiamethoxam. Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Section 3 Registration as a Seed Treatment for Alfalfa and Peanuts, and for Use in Food Handling Establishments,” available in the dockets EPA-HQ-OPP-2009-0041, EPA-HQ-OPP-2010-0324, and EPA-HQ-OPP-2010-0602, at http://www.regulations.gov; and “Clothianidin Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments,” available in the docket EPA-HQ-OPP- 2008-0771, at http://www.regulations.gov.

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).

Thiamethoxam is currently registered for the following uses that could result in residential exposures: Turfgrass on golf courses, residential lawns, commercial grounds, parks, playgrounds, athletic fields, landscapes, interiorscapes, and sod farms; indoor crack and crevice or spot treatments to control insects in residential settings. EPA assessed residential exposure using the following assumptions: Thiamethoxam is registered for use on turfgrass (on golf courses, residential lawns, commercial grounds, parks, playgrounds, athletic fields, landscapes, interiorscapes and sod farms) and for indoor use to control insects in residential settings. Thiamethoxam is applied by commercial applicators only. Therefore, exposures resulting to homeowners from applying thiamethoxam were not assessed. However, entering areas previously treated with thiamethoxam could lead to exposures for adults and children. As a result, risk assessments have been completed for postapplication scenarios.

Short-term exposures (1 to 30 days of continuous exposure) may occur as a result of activities on treated turf. Short-term and intermediate-term exposures (30 to 90 days of continuous exposure) may occur as a result of entering indoor areas previously treated with a thiamethoxam indoor crack and crevice product. The difference between short-and intermediate-term aggregate risk is the frequency of hand-to-mouth events for children. For short-term exposure there are 20 events per hour and for intermediate-term exposure there are 9.5 events per hour. The doses and end-points for short- and intermediate-term aggregate risk are the same.

EPA combined all non-dietary sources of post application exposure to obtain an estimate of potential combined exposure. These scenarios consisted of adult and toddler dermal postapplication exposure and oral (hand-to-mouth) exposures for toddlers. Since postapplication scenarios for turf occur outdoors, the potential for inhalation exposure is negligible and therefore does not require an inhalation exposure assessment. Since thiamethoxam has a very low vapor pressure (6.6 × 10 −9 Pa @ 25 °C), inhalation exposure is also expected to be negligible as a result of indoor crack and crevice use. Therefore, a quantitative postapplication inhalation exposure assessment was not performed.

A complete listing of the inputs used in these assessments can be found in the following documents: “Thiamethoxam: Occupational and Residential Exposure/Risk Assessment for Proposed Section 3 Registration for Seed Treatment Use on Peanut and Alfalfa” available in the dockets EPA-HQ-OPP-2010-0041 and EPA-HQ-OPP-2010-0324 at http://www.regulations.gov; and “Thiamethoxam: Occupational and Residential Exposure/Risk Assessment for Proposed Section 3 Registration for Use in Food/Feed Handling Establishments” available in the docket EPA-HQ-OPP-2010-0602 at http://www.regulations.gov.

Thiamethoxam use on turf or as an indoor crack and crevice or spot treatment does not result in significant residues of clothianidin. In addition, clothianidin residential and aggregate risks are not of concern. For further details, refer to the documents “Clothianidin: Human Health Risk Assessment for Proposed Uses on Berries (Group 13-07H), Brassica Vegetables (Group 5), Cotton, Cucurbit Vegetables (Group 9), Fig, Fruiting Vegetables (Group 8), Leafy Green Vegetables (Group 4A), Peach, Pomegranate, Soybean, Tree Nuts (Group 14), and Tuberous and Corm Vegetables (Group 1C)”; and “Clothianidin: Human Health Risk Assessment for Proposed Seed Treatment Uses on Root and Tuber Vegetables (Group 1), Bulb Vegetables (Group 3), Leafy Green Vegetables (Group 4A), Brassica Leafy Vegetables (Group 5), Fruiting Vegetables (Group 8), Cucurbit Vegetables (Group 9), and Cereal Grains (Group 15, except rice),” available in the docket EPA-HQ-OPP- 2008-0945, at http://www.regulations.gov.

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.”

Thiamethoxam is a member of the neonicotinoid class of pesticides and produces, as a metabolite, another neonicotinoid, clothianidin. Structural similarities or common effects 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). Although clothianidin and thiamethoxam bind selectively to insect nicotinic acetylcholine receptors (nAChR), the specific binding site(s)/receptor(s) for clothianidin, thiamethoxam, and the other neonicotinoids are unknown at this time. Additionally, the commonality of the binding activity itself is uncertain, as preliminary evidence suggests that clothianidin operates by direct competitive inhibition, while thiamethoxam is a non-competitive inhibitor. Furthermore, even if future research shows that neonicotinoids share a common binding activity to a specific site on insect nicotinic acetylcholine receptors, there is not necessarily a relationship between this pesticidal action and a mechanism of toxicity in mammals. Structural variations between the insect and mammalian nAChRs produce quantitative differences in the binding affinity of the neonicotinoids towards these receptors, which, in turn, confers the notably greater selective toxicity of this class towards insects, including aphids and leafhoppers, compared to mammals. While the insecticidal action of the neonicotinoids is neurotoxic, the most sensitive regulatory endpoint for thiamethoxam is based on unrelated effects in mammals, including effects on the liver, kidney, testes, and hematopoietic system.

Additionally, the most sensitive toxicological effect in mammals differs across the neonicotinoids ( e.g., testicular tubular atrophy with thiamethoxam; mineralized particles in thyroid colloid with imidacloprid).

Thus, EPA has not found thiamethoxam or clothianidin to share a common mechanism of toxicity with any other substances. For the purposes of this tolerance action, therefore, EPA has assumed that thiamethoxam and clothianidin do not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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

2. Prenatal and postnatal sensitivity. In the developmental studies, there is no evidence of increased quantitative or qualitative susceptibility of rat or rabbit fetuses to in utero exposure to thiamethoxam. The developmental NOAELs are either higher than or equal to the maternal NOAELs. The toxicological effects in fetuses do not appear to be any more severe than those in the dams or does. In the rat DNT study, there was no quantitative evidence of increased susceptibility.

There is evidence of increased quantitative susceptibility for male pups in two 2-generation reproductive studies. In one study, there are no toxicological effects in the dams whereas for the pups, reduced bodyweights are observed at the highest dose level, starting on day 14 of lactation. This contributes to an overall decrease in bodyweight gain during the entire lactation period. Additionally, reproductive effects in males appear in the F1 generation in the form of increased incidence and severity of testicular tubular atrophy. These data are considered to be evidence of increased quantitative susceptibility for male pups (increased incidence of testicular tubular atrophy at 1.8 milligrams/kilogram/day (mg/kg/day)) when compared to the parents (hyaline changes in renal tubules at 61 mg/kg/day; NOAEL is 1.8 mg/kg/day).

In a more recent 2-generation reproduction study, the most sensitive effect was sperm abnormalities at 3 mg/kg/day (the NOAEL is 1.2 mg/kg/day) in the F1 males. This study also indicates increased susceptibility for the offspring for this effect.

Although there is evidence of increased quantitative susceptibility for male pups in both reproductive studies, NOAELs and LOAELs were established in these studies and the Agency selected the NOAEL for testicular effects in F1 pups as the basis for risk assessment. The Agency has confidence that the NOAEL selected for risk assessment is protective of the most sensitive effect (testicular effects) for the most sensitive subgroup (pups) observed in the toxicological database.

3. Conclusion. i. In the final rule published in the Federal Register of January 5, 2005 (70 FR 708) (FRL-7689-7), EPA had previously determined that the FQPA SF should be retained at 10X for thiamethoxam, based on the following factors: Effects on endocrine organs observed across species; significant decrease in alanine amino transferase levels in companion animal studies and in dog studies; the mode of action of this chemical in insects (interferes with the nicotinic acetylcholine receptors of the insect's nervous system); the transient clinical signs of neurotoxicity in several studies across species; and the suggestive evidence of increased quantitative susceptibility in the rat reproduction study. Since that determination, EPA has received and reviewed a city DNT study in rats, and an additional reproduction study in rats.

Taking the results of these studies into account, as well as the rest of the data on thiamethoxam, 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 (June 23, 2010, 75 FR 35653; FRL-8830-4); (June 22, 2007, 72 FR 34401). That decision is based on the following findings:

a. The toxicity database for thiamethoxam is largely complete, including acceptable/guideline developmental toxicity, 2-generation reproduction, and DNT studies designed to detect adverse effects on the developing organism, which could result from the mechanism that may have produced the decreased alanine amino transferase levels.

The registrant must now submit, as a condition of registration, an immunotoxicity study.

This study is now required under 40 CFR part 158.

The available data for thiamethoxam show the potential for immunotoxic effects. In the subchronic dog study, leukopenia (decreased white blood cells) was observed in females only, at the highest dose tested (HDT) of 50 mg/kg/day; the NOAEL for this effect was 34 mg/kg/day. The overall study NOAEL was 9.3 mg/kg/day in females (8.2 mg/kg/day in males) based on hematology and other clinical chemistry findings at the LOAEL of 34 mg/kg/day (32 mg/kg/day in males). In the subchronic mouse study, decreased spleen weights were observed in females at 626 mg/kg/day; the NOAEL for this effect was the next lowest dose of 231 mg/kg/day. The overall study NOAEL was 1.4 mg/kg/day (males) based on increased hepatocyte hypertrophy observed at the LOAEL of 14.3 mg/kg/day. The decreased absolute spleen weights were considered to be treatment related, but were not statistically significant at 626 mg/kg/day or at the HDT of 1,163 mg/kg/day. Since spleen weights were not decreased relative to body weights, the absolute decreases may have been related to the decreases in body weight gain observed at higher doses.

Overall, the Agency has a low concern for the potential for immunotoxicity related to these effects for the following reasons: In general, the Agency does not consider alterations in hematology parameters alone to be a significant indication of potential immunotoxicity. In the case of thiamethoxam, high-dose females in the subchronic dog study had slight microcytic anemia as well as leukopenia characterized by reductions in neutrophils, lymphocytes and monocytes; the leukopenia was considered to be related to the anemic response to exposure. Further, endpoints and doses selected for risk assessment are protective of the observed effects on hematology. Spleen weight decreases, while considered treatment-related, were associated with decreases in body weight gain, and were not statistically significant. In addition, spleen weight changes occurred only at very high doses, more than 70 times higher than the doses selected for risk assessment. Therefore, an additional 10X safety factor is not warranted for thiamethoxam at this time.

b. For the reasons discussed in Unit III.D.2., there is low concern for an increased susceptibility in the young.

c. Although there is evidence of neurotoxicity after acute exposure to thiamethoxam at doses of 500 mg/kg/day including drooped palpebral closure, decrease in rectal temperature and locomotor activity and increase in forelimb grip strength, no evidence of neuropathology was observed. These effects occurred at doses at least fourteen-fold and 416-fold higher than the doses used for the acute, and chronic risk assessments, respectively; thus, there is low concern for these effects since it is expected that the doses used for regulatory purposes would be protective of the effects noted at much higher doses.

In the DNT study, there was no evidence of neurotoxicity in the dams exposed up to 298.7 mg/kg/day; a dose that was associated with decreases in body weight gain and food consumption. In pups exposed to 298.7 mg/kg/day, there were significant reductions in absolute brain weight and size ( i.e., length and width of the cerebellum was less in males on day 12, and there were significant decreases in Level 3-5 measurements in males and in Level 4-5 measurements in females on day 63). However, there is low concern for this increased qualitative susceptibility observed in the DNT study because the doses and endpoints selected for risk assessment are protective of the effects in the offspring. As noted previously, the Agency selected the NOAEL for testicular effects in F1 pups based on two reproductive toxicity studies for risk assessment to be protective of all sensitive subpopulations.

d. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed using tolerance-level and/or anticipated residues that are based on reliable field trial data observed in the thiamethoxam field trials. Although there is available information indicating that thiamethoxam and clothianidin have different toxicological effects in mammals and should be assessed separately, the residues of each have been combined in these assessments to ensure that the estimated exposures of thiamethoxam do not underestimate actual potential thiamethoxam exposures. An assumption of 100 PCT was made for all foods evaluated in the assessments. For the acute and chronic assessments, the EDWCs of 131.77 ppb and 11.3 ppb, respectively, were used to estimate exposure via drinking water. Compared to the results from small scale prospective ground water studies where the maximum observed residue levels from any monitoring well were 1.0 ppb for thiamethoxam and 0.73 ppb for clothianidin, the modeled estimates are protective of what actual exposures are likely to be. Similarly conservative residential standards of procedures, as well as a chemical specific turf transfer residue (TTR) study were used to assess postapplication exposure to children and incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by thiamethoxam.

ii. In the final rule published in the Federal Register of February 6, 2008 (73 FR 6851) (FRL-8346-9), EPA had previously determined that the FQPA SF for clothianidin should be retained at 10X because EPA had required the submission of a DNT study to address the combination of evidence of decreased absolute and adjusted organ weights of the thymus and spleen in multiple studies in the clothianidin database, and evidence showing that juvenile rats in the 2-generation reproduction study appear to be more susceptible to these potential immunotoxic effects. In the absence of a DNT study, EPA concluded that there was sufficient uncertainty regarding immunotoxic effects in the young that the 10X FQPA factor should be retained as a database uncertainty factor.

Since that determination, EPA has received and reviewed an acceptable/guideline DNT study, which demonstrated no treatment-related effects. Taking the results of this study into account, as well as the rest of the data on clothianidin, EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF for clothianidin were reduced to 1X (February 11, 2011, 76 FR 7712) (FRL-8858-3). That decision is based on the following findings:

a. The toxicity database for clothianidin is complete. As noted, the prior data gap concerning developmental immunotoxicity has been addressed by the submission of an acceptable DNT study.

b. A rat DNT study is available and shows evidence of increased quantitative susceptibility of offspring. However, EPA considers the degree of concern for the DNT study to be low for prenatal and postnatal toxicity because the NOAEL and LOAEL were well characterized, and the doses and endpoints selected for risk assessment are protective of the observed susceptibility; therefore, there are no residual concerns regarding effects in the young.

c. While the rat multi-generation reproduction study showed evidence of increased quantitative susceptibility of offspring compared to adults, the degree of concern is low because the study NOAEL and LOAEL have been selected for risk assessment purposes for relevant exposure routes and durations. In addition, the potential immunotoxic effects observed in the study have been further characterized with the submission of a DNT study that showed no evidence of susceptibility. As a result, there are no concerns or residual uncertainties for prenatal and postnatal toxicity after establishing toxicity endpoints and traditional UFs to be used in the risk assessment for clothianidin.

d. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on assumptions that were judged to be highly conservative and health-protective for all durations and population subgroups, including tolerance-level residues, adjustment factors from metabolite data, empirical processing factors, and 100 PCT for all commodities. Additionally, EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to clothianidin in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children and adults as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by clothianidin.

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 thiamethoxam will occupy 9.5% of the aPAD for all infants (<1 year), the population group receiving the greatest exposure. Acute dietary exposure from food and water to clothianidin is estimated to occupy 23% of the aPAD for children 1 to 2 years 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 thiamethoxam from food and water will utilize 43% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. Chronic exposure to clothianidin from food and water will utilize 19% of the cPAD for children 1 to 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 thiamethoxam and clothianidin 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).

Thiamethoxam 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 thiamethoxam. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures for thiamethoxam result in aggregate MOEs of: 370 for the general U.S. population; 490 for all infants (<1 year); 440 for children 1 to 2 years; 450 for children 3-5 years; 370 for children 6-12 years; 380 for youth 13-19 years, adults 20-49 years, adults 50+ years, and females 13-49 years. Because EPA's level of concern for thiamethoxam is a MOE of 100 or below, these MOEs are not of concern.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures for clothianidin result in aggregate MOEs of: 1,700 for the general U.S. population; 480 for all infants (<1 year); 380 for children 1 to 2 years; 500 for children 3-5 years; 1,400 for children 6-12 years; 2,200 for youth 13-19 years, adults 20-49 years, and females 13-49 years; 2,100 for adults 50+ years. Because EPA's level of concern for clothianidin 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).

Thiamethoxam 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 thiamethoxam.

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in aggregate MOEs of 370 for the general U.S. population; 540 for all infants (<1 year); 470 for children 1 to 2 years; 490 for children 3-5 years; 370 for children 6-12 years; 380 for youth 13-19 years, adults 20-49 years, adults 50+ years, and females 13-49 years. Because EPA's level of concern for thiamethoxam is a MOE of 100 or below, these MOEs are not of concern.

Using the exposure assumptions described in this unit for intermediate exposures, EPA has concluded the combined intermediate food, water, and residential exposures for clothianidin result in aggregate MOEs of 1,700 for the general U.S. population; 480 for all infants (<1 year); 380 for children 1 to 2 years; 500 for children 3-5 years; 1,400 for children 6-12 years; 2,200 for youth 13-19 years, adults 20-49 years, and females 13-49 years; 2,100 for adults 50+ years. Because EPA's level of concern for clothianidin is a MOE of 100 or below, these MOEs are not of concern.

5. Aggregate cancer risk for U.S. population . The Agency has classified thiamethoxam as not likely to be a human carcinogen based on convincing evidence that a non-genotoxic mode of action for liver tumors was established in the mouse and that the carcinogenic effects are a result of a mode of action dependent on sufficient amounts of a hepatotoxic metabolite produced persistently. Therefore, thiamethoxam is not expected to pose a cancer risk.

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

Adequate enforcement methodology (high-performance liquid chromatography/ultraviolet (HPLC/UV) or mass spectrometry (MS)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

For further details, refer to the document “Thiamethoxam—Human Health Risk Assessment for New Seed Treatment Uses on Alfalfa and Peanuts, and Use in Food Handling Establishments” in the dockets EPA-HQ-2010-0041, EPA-HQ-OPP-2010-0324, EPA-HQ-OPP-2010-0602, at http://www.regulations.gov and “Thiamethoxam. Petition to Establish a Permanent Tolerance for Residues of the Insecticide Resulting from Food/Feed Use as a Seed Treatment on Bulb Onions. Response to Data Gaps from Conditional Registration of Various Food/Feed Crops (as Specified in HED Memo D281702; M. Doherty; 17 April 2007). Summary of Analytical Chemistry and Residue Data,” available in the docket EPA-HQ-OPP-2009-0737, at http://www.regulations.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 thiamethoxam.

Comments were received in dockets EPA-HQ-OPP-2010-0324 and EPA-HQ-OPP-2010-0602 from a private citizen who opposes any pesticide that leaves a residue on food. The Agency has received these same comments from this commenter on numerous previous occasions and rejects them for reasons previously stated. 70 FR 1349, 1354 (January 7, 2005).

EPA made two revisions to the tolerances as proposed: The addition of a tolerance for peanut meal and an increase in the proposed tolerance for food commodities and feed commodities (other than those covered by a higher tolerance as a result of use on growing crops) in food/feed handling establishments.

In addition to the two requested raw agricultural commodity tolerances for peanut and peanut hay, EPA considered the residues on processed peanut commodities. The processed commodities associated with the proposed use on peanuts are peanut meal and refined oil. Two peanut field trials were conducted in the U.S. during the 1999 growing season in which peanut seeds treated at an exaggerated (roughly 6-6.5X) rate were grown for processing into peanut meal and refined oil. Thiamethoxam residues were not detected in the nutmeat nor processed fractions of peanuts grown from peanut seeds treated at the 6-6.5X rate. Residues were not detected in any of the peanut oil samples upon processing. Residues were observed in the nutmeat and meal of peanuts, grown from peanut seeds treated at roughly a 2X rate, from both field trials. The theoretical concentration factor for peanut meal (EPA Residue Chemistry Test Guideline 860.1520, Table 3) is 2.2X. The empirical concentration factors for thiamethoxam in meal (range 2.0-3.1X, average 2.6X) conform well to the theoretical value. A tolerance is not required in peanut oil. However, based on the highest average field trial combined residues of 0.05 ppm (0.09 ppm at a 2X rate) in peanut nutmeat, and the theoretical concentration factor for peanut meal of 2.2X, EPA is setting a tolerance of 0.15 ppm in peanut meal.

The submitted data for thiamethoxam use in food handling areas are acceptable and support the proposed use (spot, void, and crack and crevice treatment) in food handling establishments. An adequate variety of food commodities were exposed to thiamethoxam, in two different types of food handling establishments, at 1X the maximum proposed rate. Maximum thiamethoxam and clothianidin residues were each <0.01 ppm in food commodities exposed to 1X treatment in food handling areas (with the vast majority of samples containing non-detectable residues). The registrants proposed tolerance had failed to add these two sources together. EPA is setting a tolerance of 0.02 ppm in food commodities and feed commodities (other than those covered by a higher tolerance as a result of use on growing crops) in food/feed handling establishments based on the presence of detectable residues of thiamethoxam added to detectable residues of the metabolite clothianidin in various samples.

Therefore, tolerances are established for residues of thiamethoxam, 3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl- N -nitro-4 H -1,3,5-oxadiazin-4-imine and its metabolite, N -(2-chloro-thiazol-5-ylmethyl)- N′ -methyl- N′ -nitro-guanidine, in or on peanut at 0.05 ppm; peanut hay at 0.25 ppm; peanut meal at 0.15 ppm; alfalfa, forage at 0.05 ppm; alfalfa, hay at 0.12 ppm; and food commodities and feed commodities (other than those covered by a higher tolerance as a result of use on growing crops) in food/feed handling establishments at 0.02 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, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (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. 801 et seq ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

The modified BFEs are not listed for each community in this interim rule. However, the address of the Chief Executive Officer of the community where the modified BFE determinations are available for inspection is provided.

Any request for reconsideration must be based on knowledge of changed conditions or new scientific or technical data.

The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The modified BFEs are the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP).

These modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The changes in BFEs are in accordance with 44 CFR 65.4.

National Environmental Policy Act. This interim rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

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

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

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

Accordingly, 44 CFR part 65 is amended to read as follows:

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below of the modified BFEs for each community listed. These modified BFEs have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Deputy Federal Insurance and Mitigation Administrator has resolved any appeals resulting from this notification.

The modified BFEs are not listed for each community in this notice. However, this final rule includes the address of the Chief Executive Officer of the community where the modified BFE determinations are available for inspection.

The modified BFEs are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The modified BFEs are the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP).

These modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities.

These modified BFEs are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in those buildings. The changes in BFEs are in accordance with 44 CFR 65.4.

National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

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

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

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

Accordingly, 44 CFR part 65 is amended to read as follows:

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Deputy Federal Insurance and Mitigation Administrator has resolved any appeals resulting from this notification.

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community. The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.

National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

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

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

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

Accordingly, 44 CFR part 67 is amended as follows:

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Deputy Federal Insurance and Mitigation Administrator has resolved any appeals resulting from this notification.

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community.

The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.

National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

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

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

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

Accordingly, 44 CFR part 67 is amended as follows:

The Board is issuing this final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Board finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because publishing a NPRM would be unnecessary. This amendment is a non-substantive change to the Rules, intended to improve the efficiency and effectiveness of the Board's programs by providing parties with an additional option for filing their documents. This option of electronic filing does not affect any of the other methods currently available to parties for the delivery of documents, including in person, by United States Postal Service or other courier service, or by facsimile transmission.

The Civilian Board of Contract Appeals was established within the General Services Administration (GSA) by Section 847 of the National Defense Authorization Act for Fiscal Year 2006, Public Law 109-163 (now codified at 41 U.S.C. 7105(b)). In March 2011, the Civilian Board of Contract Appeals began accepting filings submitted by electronic mail (e-mail) under Section 6101.1(b)(5) of the Board's Rules of Procedure. However, appeal files submitted pursuant to Section 6101.4 of the Board's Rules of Procedure may not be submitted by electronic mail due to the size and complexity of these filings, and classified documents and files submitted in camera or under protective order pursuant to Section 6101.9(c) of the Board's Rules of Procedure may not be submitted by electronic mail due to the need to ensure their security. This final rule updates section 6101.1(b)(5) to include information regarding the filing of documents by e-mail and to provide direction concerning requirements for their submittal. Sections 6101.1(f), 6101.2(a)(1)(ii)(C), 6101.2(a)(1)(ii)(D), 6101.2(a)(2)(ii)(C), 6101.5(c), 6103.302(a)(1), 6103.302(b), 6104.402(a)(1)(i), 6104.402(a)(1)(ii), 6104.402(a)(3), 6105.502(a)(2)(iii)(A), 6105.502(a)(2)(iii)(B), and 6105.502(a)(2)(iv) are also amended to provide the e-mail address for receipt of filings for the Clerk of the Board and to request additional contact information for parties and their agents or representatives. Sections 6101.25(a)(1), 6103.306, 6104.406, and 6105.505 are amended to provide the current Internet address for the Board. In addition, section 6101.5(c) is amended to correct an error in printing by the Code of Federal Regulations.

The General Services Administration certifies that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because the rule does not impose any additional costs on large or small businesses.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under Section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

The Paperwork Reduction Act does not apply because the changes do not impose recordkeeping or information collection requirements, or otherwise collect information from offerors, contractors, or members of the public that require approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

Therefore, GSA amends 48 CFR parts 6101, 6103, 6104, and 6105 as set forth below: