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Code · REGISTER · 2007-09-26 · Food and Drug Administration, HHS · Rules and Regulations

Rules and Regulations. Final rule

58,663 words·~267 min read·/register/2007/09/26/07-55511

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 9111-14-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the animal drug regulations to reflect approval of a supplemental new animal drug application
(NADA)filed by Pfizer, Inc. The supplemental NADA provides for the addition of a pathogen to the indication for use of tulathromycin, by injection, for the control of respiratory disease in high-risk cattle. DATES: This rule is effective September 26, 2007. FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: *joan.gotthardt@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement to NADA 141-244 for DRAXXIN (tulathromycin) Injectable Solution. The supplemental NADA provides for the addition of a pathogen, *Mycoplasma bovis* , to the indication for use of tulathromycin solution in cattle, by subcutaneous injection, for the control of respiratory disease in cattle at high risk of developing bovine respiratory disease. The application is approved as of September 4, 2007, and the regulations in 21 CFR 522.2630 are amended to reflect the approval. In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years of marketing exclusivity beginning on the date of approval. The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 522 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is amended as follows: PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: Authority: 21 U.S.C. 360b. § 522.2630 [Amended] 2. In § 522.2630, in paragraph (d)(1)(ii), remove “and *H. somni* ” and add in its place “ *H. somni* , and *M. bovis* ”. Dated: September 17, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine [FR Doc. E7-18983 Filed 9-25-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF THE TREASURY Office of the Secretary 31 CFR Part 10 [TD 9359] RIN 1545-BA72 Regulations Governing Practice Before the Internal Revenue Service AGENCY: Office of the Secretary, Treasury. ACTION: Final regulations. SUMMARY: This document contains final regulations revising the regulations governing practice before the Internal Revenue Service (Circular 230). These regulations affect individuals who practice before the Internal Revenue Service (IRS). The amendments modify the general standards of practice before the IRS. DATES: *Effective Date:* These regulations are effective September 26, 2007. *Applicability Date:* For dates of applicability, see §§ 10.1(d), 10.2(b), 10.3(i), 10.4(e), 10.5(f), 10.6(p), 10.7(g), 10.22(c), 10.25(e), 10.27(d), 10.29(d), 10.30(e), 10.34(f), 10.50(e), 10.51(b), 10.52(b), 10.53(e), 10.60(d), 10.61(c), 10.62(d), 10.63(f), 10.65(c), 10.68(e), 10.70(c), 10.71(g), 10.72(g), 10.73(g), 10.76(e), 10.77(c), 10.78(d), 10.82(h), 10.90(b), and 10.91. FOR FURTHER INFORMATION CONTACT: Matthew Cooper at
(202)622-4940. SUPPLEMENTARY INFORMATION: Background Section 330 of title 31 of the United States Code authorizes the Secretary of the Treasury to regulate the practice of representatives before the Treasury Department. The Secretary is authorized, after notice and an opportunity for a proceeding, to censure, suspend or disbar from practice before the Treasury Department those representatives who are incompetent, disreputable, or who violate regulations prescribed under section 330 of title 31. The Secretary also is authorized to impose a monetary penalty against these individuals or seek an injunction under section 7408 of the Internal Revenue Code. The Secretary has published regulations governing the practice of representatives before the IRS in Circular 230 (31 CFR part 10). These regulations authorize the Director of the Office of Professional Responsibility to act upon applications for enrollment to practice before the IRS, to make inquiries with respect to matters under the Office of Professional Responsibility's jurisdiction, to institute proceedings to impose a monetary penalty or to censure, suspend or disbar a practitioner from practice before the IRS, to institute proceedings to disqualify appraisers, and to perform other duties necessary to carry out these functions. On December 19, 2002 (67 FR 77724), the Treasury Department and the IRS issued an advance notice of proposed rulemaking (2002 ANPRM) requesting comments on amendments to the regulations relating to the Office of Professional Responsibility, unenrolled practice, eligibility for enrollment, sanctions and disciplinary proceedings, contingent fees and confidentiality agreements. On February 8, 2006, the Treasury Department and the IRS published in the **Federal Register** (71 FR 6421) proposed amendments to the regulations (REG-122380-02) reflecting consideration of the comments received in response to the 2002 ANPRM and reflecting amendments to section 330 of title 31 made by the American Jobs Creation Act of 2004, Public Law 108-357 (118 Stat. 1418) (the Jobs Act). A public hearing was held on these proposals on June 21, 2006. Written public comments responding to the proposed regulations were received. After consideration of the public comments, the proposed regulations are adopted as revised by this Treasury decision. Summary of Comments and Explanation of Revisions Over 30 written comments were received in response to the notice of proposed rulemaking. All comments were considered and are available for public inspection upon request. A number of these comments are summarized in this preamble. The scope of these regulations is limited to practice before the IRS. These regulations do not alter or supplant ethical standards that are otherwise applicable to practitioners. Definitions—Practice Before the Internal Revenue Service Section 10.2(a)(4) of the final regulations adopts the proposed change without modification. The final regulations provide that practice before the IRS comprehends all matters connected with a presentation to the IRS or any of its officers or employees relating to a taxpayer's rights, privileges, or liabilities under laws or regulations administered by the IRS. Consistent with the Jobs Act amendment to section 330 of title 31, the final regulations provide that practice includes rendering written advice with respect to any entity, transaction, plan or arrangement, or other plan or arrangement having a potential for tax avoidance or evasion. Several commentators stated that, notwithstanding the clarification provided by the Jobs Act, the rendition of tax advice is not, in and of itself, an act constituting practice before the IRS. The Treasury Department and IRS conclude that the rendering of written advice is practice before the IRS subject to Circular 230 when it is provided by a practitioner. Who May Practice Sections 10.3(a) and
(b)of these final regulations clarify that an attorney or CPA is not required to file a Form 2848, “Power of Attorney and Declaration of Representative”, with the IRS before rendering written advice covered under § 10.35 or § 10.37. As stated earlier in this preamble, the rendering of this advice is practice before the IRS when provided by a practitioner. Any practice before the IRS other than the rendering of written advice covered under § 10.35 or § 10.37 continues to require the attorney or CPA to file a Form 2848 with the IRS. The notice of proposed rulemaking invited comments on a proposal from the Advisory Committee for Tax Exempt/Governmental Entities recommending that individuals who provide technical services to plan sponsors to maintain the tax qualified status of their retirement plans (retirement plan administrators) be authorized to practice provided they demonstrate the competency to do so. The commentators supported this proposal provided that practice is limited to representing taxpayers with respect to qualified retirement plan issues. In light of the favorable comments and the immediate need for this program, the final regulations under § 10.3(e) establish an enrolled retirement plan agent designation, subject to the limitations identified in these regulations. These regulations generally limit the practice of enrolled retirement plan agents to representation with respect to issues arising under the following employee plan programs:
(1)Employee Plans Determination Letter program;
(2)Employee Plans Compliance Resolution System; and
(3)Employee Plans Master and Prototype and Volume Submitter program. Enrolled retirement plan agents also are permitted to represent taxpayers generally with respect to IRS forms under the 5300 and 5500 series, which are filed by retirement plans and plan sponsors, but not with respect to actuarial forms or schedules. The Advisory Committee recommended the implementation of procedures for enrollment similar to the current enrolled agent program. The Treasury Department and IRS adopt that recommendation. Enrolled retirement plan agents will be subject to an examination to determine competency, a renewal process and continuing professional education requirements. Enrollment Procedures Sections 10.4, 10.5 and 10.6 of the regulations set forth the applicable procedures relating to the enrollment and renewal of enrollment of an enrolled agent. The final regulations adopt the proposed changes in these sections with one modification. Sections 10.5(b) and 10.6(d)(6) are revised to reflect the publishing of TD 9288 (71 FR 58740), which establishes user fees for enrollment and renewal of this enrollment in 26 CFR part 300, on October 5, 2006. The procedures in §§ 10.4, 10.5, and 10.6 also are expanded to include the enrollment and renewal of enrollment for the new category of enrolled retirement plan agents. Limited Practice Before the IRS The final regulations do not adopt the provisions governing limited practice as proposed under § 10.7. Accordingly, the authorization in § 10.7(c)(viii), which allows an individual, who was not otherwise a practitioner, to represent a taxpayer during an examination if that individual prepared the return for the taxable period under examination, is retained. An unenrolled return preparer who prepared the taxpayer's return for the year under examination, therefore, may continue to negotiate with the IRS on behalf of that taxpayer during an examination or bind that taxpayer to a position during an examination. The unenrolled return preparer, however, may still not represent a taxpayer before any other office of the IRS, including Collection or Appeals; execute closing agreements, claims for refund, or waivers; or otherwise represent taxpayers before the IRS unless authorized by § 10.7(c)(1)(i) through (vii). These final regulations do not adopt one commentator's suggestion that payroll reporting agents be allowed to represent taxpayers on a limited basis with respect to Federal tax deposits made by the payroll agents on behalf of their clients. Payroll agents have not demonstrated their qualifications to practice before the IRS as required under section 330(a)(2) of title 31. Payroll agents may assist, however, in the exchange of information with the IRS regarding a taxpayer's return if the taxpayer specifically authorizes the payroll agent to receive confidential tax information from the IRS through the use of a tax information authorization. Practice by Former Government Employees, Their Partners and Their Associates The final regulations adopt the proposed amendments to § 10.25, with modification. The final regulations modify § 10.25(b)(4) to prohibit, for a period of one year after Government employment is ended, former employees from appearing before, or communicating with the intent to influence, an employee of the Treasury Department with respect to a rule in which they were involved in developing. This modification is consistent with the scope of activities covered by 18 U.S.C. 207(a) and 207(c). Commentators generally supported the changes to § 10.25 governing the restrictions on the practice of former Government employees, their partners, and their associates with respect to matters that the former Government employees participated in during the course of their Government employment. Contingent Fees The final regulations adopt the amendments as proposed in § 10.27, with several modifications. Most commentators opposed further limitations on contingent fees under § 10.27 and supported the withdrawal or significant modification of this section. Specifically, several commentators stated that the proposed rules were overly broad, improperly interfered with the practitioner-client relationship, and prohibited some small and middle market taxpayers from appropriately requesting refunds. Another group of commentators requested that contingent fees be allowed in situations in which IRS review of the taxpayer's position is probable and the fees do not provide an incentive for abuse (including interest and penalty reviews, private letter rulings, pre-filing agreements, advance pricing agreements, and requests for relief under section 9100). The Treasury Department and the IRS continue to believe that a rule restricting contingent fees for preparing tax returns supports voluntary compliance with the Federal tax laws by discouraging return positions that exploit the audit selection process. In particular, the Treasury Department and IRS are concerned with the use of contingent fee arrangements in connection with claims for refund or amended returns filed late in the examination process. Balancing these concerns with the appropriate use of contingent fee arrangements in other situations, the final regulations permit a practitioner to charge a contingent fee for services rendered in connection with the IRS examination of, or challenge, to
(i)An original tax return, or
(ii)an amended return or claim for refund or credit where the amended return or claim for refund or credit was filed within 120 days of the taxpayer receiving a written notice of the examination or a written challenge to the original tax return. Based on comments received, the final regulations also permit the use of contingent fees for interest and penalty reviews because there is no exploitation of the audit lottery in these situations as they are generally completed on a post-examination basis. A practitioner, therefore, may charge a contingent fee for services rendered in connection with a claim for credit or refund filed in connection with the determination of statutory interest or penalties assessed by the Internal Revenue Service. Finally, the final regulations adopt the amendment in proposed § 10.27 which allows a practitioner to charge a contingent fee for services rendered in connection with any judicial proceeding arising under the Internal Revenue Code. To eliminate any adverse impact that the adoption of these final regulations could have on pending or imminent transactions, § 10.27(d), as amended, will apply to fee arrangements entered into after March 26, 2008. Conflicting Interests The final regulations adopt the proposed amendments found in § 10.29 with modification. Under the final regulations, a practitioner is required to obtain consent to the representation from each affected client in writing in order to represent the conflicting interests. The written consent may vary in form. The practitioner may prepare a letter to the client outlining the conflict, as well as the possible implications of the conflict, and submit the letter to the client for the client to countersign. Unlike American Bar Association model rule 1.7, which permits affected clients to provide informed consent verbally if the consent is contemporaneously documented by the practitioner in writing, a verbal consent followed by a confirmatory letter authored by the practitioner will not satisfy § 10.29 unless the confirmatory letter is countersigned by the client. A number of commentators opposed the proposed rules on the grounds that it is arguably broader than American Bar Association model rule 1.7. The Treasury Department and IRS, however, conclude that the language in the final regulations is appropriate to protect taxpayer interests and protect settlements from future collateral attack. In order to provide greater flexibility to both the practitioner and client, the Treasury Department and IRS have revised the final regulations to allow the confirmation to be made within a reasonable period after the informed consent, but in no event later than 30 days. It is not the intent of the Treasury Department and IRS to sanction minor technical violations of this final § 10.29 when there is little or no injury to a client, the public, or tax administration. For example, if a client fails to return the confirmatory writing to the practitioner, notwithstanding the practitioner's documented good faith effort to obtain the client's signature, the practitioner would not be subject to a sanction or monetary penalty provided the practitioner promptly withdrew from representation upon the failure to receive the client's written confirmation within a reasonable period. Standards With Respect to Tax Returns and Documents, Affidavits and Other Papers Section 10.34 sets forth standards applicable to advice with respect to tax return positions and applicable to preparing or signing returns. These final regulations adopt § 10.34 as proposed, with modifications. On May 25, 2007, the President signed into law the Small Business and Work Opportunity Tax Act of 2007, Public Law 110-28 (121 Stat. 190), which amended several provisions of the Code to extend the application of the income tax return preparer penalties to all tax return preparers, alter the standards of conduct that must be met to avoid imposition of the penalties for preparing a return that reflects an understatement of liability, and increase applicable penalties. On June 11, 2007, the IRS released Notice 2007-54, 2007-27 IRB 1 (see § 601.601(d)(2)(ii)( *b* )), providing guidance and transitional relief for the return preparer provisions under section 6694 of the Code, as recently amended. The standards with respect to tax returns under § 10.34(a) in these final regulations do not reflect amendments to the Code made by the Small Business and Work Opportunity Tax Act of 2007. Rather, the Treasury Department and the IRS are reserving § 10.34(a) and
(e)in these final regulations and are simultaneously issuing a notice of proposed rulemaking proposing to amend this part to reflect these recent amendments to the Code. Several commentators requested that the Treasury Department and the IRS clarify the rule concerning advising a client to submit a document that contains or omits information in a manner that demonstrates an intentional disregard of a rule or regulation and a taxpayer's right to offer a good faith challenge to a rule or regulation. The language under § 10.34(b)(2)(iii) now provides that a practitioner may not advise a client to submit a document to the IRS that contains or omits information in a manner that demonstrates an intentional disregard of a rule or regulation unless the practitioner also advises the client to submit a document showing a good faith challenge to the rule or regulation. Sanctions The final regulations adopt the amendments under § 10.50 authorizing the imposition of a monetary penalty in addition to, or in lieu of, any other sanction in accordance with section 822(a) of the Jobs Act. The Treasury Department and the IRS released Notice 2007-39, 2007-20 IRB 1243 (see § 601.601(d)(2)(ii)( *b* )), on April 23, 2007, which provides guidance for practitioners, employers, firms, and other entities that may be subject to monetary penalties. In addition, the Notice requests comments from the public regarding rules and standards relating to the imposition of the monetary penalty. The regulations also contain conforming amendments to other provisions relating to sanctions, including modifications made by section 1219 of the Pension Protection Act of 2006, Public Law 109-280 (120 Stat. 780). The Secretary of the Treasury, or delegate, after due notice and opportunity for hearing, may now disqualify an appraiser who violates Circular 230 with or without the assessment of a section 6701 penalty against the appraiser. Incompetence and Disreputable Conduct Section 10.51 of the regulations defines disreputable conduct for which a practitioner may be sanctioned. A number of commentators stated that inclusion of “failure to sign a tax return” as a type of disreputable conduct is inappropriate unless the rule clarifies how the practitioner should appropriately handle competing duties, including section 6694 of the Internal Revenue Code or § 10.34 of Circular 230. The Treasury Department and the IRS agree that there might be instances in which the failure to sign a return should not lead to discipline. Therefore, § 10.51(a)(14) of the final regulations is modified to provide that failure to sign a return is not disreputable conduct if the failure is due to reasonable cause and not due to willful neglect. This change is consistent with the standard applied under section 6695(b) of the Code. Conferences The final regulations adopt the proposed rule in § 10.61(a) relating to the ability of the Director of the Office of Professional Responsibility to confer with a practitioner, employer, firm or other entity, or an appraiser concerning allegations of misconduct irrespective of whether a proceeding has been instituted. Commentators suggested that the practitioner, employer, firm or other entity, or an appraiser be provided with a right to a conference with the Office of Professional Responsibility. The commentators' suggestion was not adopted in light of the Office of Professional Responsibility's policy that it will not deny a first request for conference made by a practitioner, employer, firm or other entity, or an appraiser regarding allegations of misconduct. The Office of Professional Responsibility may conduct a conference by telephonic means or in person. Service of Complaint The final regulations adopt the rules related to service of the complaint as proposed. Proposed regulations in § 10.63(d) provide that within 10 days of serving the complaint, copies of the evidence in support of the complaint must be served on the respondent in any manner provided by regulations. Commentators requested that the Director of the Office of Professional Responsibility furnish evidence not solely in support of the complaint, but also additional evidence collected during the course of investigating the conduct of the respondent, including any exculpatory evidence. Although not formalized in the regulations or the Internal Revenue Manual currently, the current practice of the Office of Professional Responsibility is to provide to the respondent upon request a copy of what informally is understood as the “OPR administrative file” prior to the filing of a complaint under § 10.60. In general, the OPR administrative file contains material that the Office of Professional Responsibility considered in the course of determining whether to issue a final complaint. Some material related to the case, including but not limited to legal memoranda provided to the Office of Professional Responsibility by the Office of Chief Counsel will not be included in the OPR administrative file. The Treasury Department and IRS intend for the practice of releasing the OPR administrative file upon request to continue. This practice addresses in part commentators' concern that documents included in the investigatory file, including releasable exculpatory evidence, be provided to the respondent. The IRS expects to issue Internal Revenue Manual provisions in the near future pertaining to the Office of Professional Responsibility's procedures for investigations. It is expected that those provisions will formalize the definition of the OPR administrative file and the current practice of providing it to the respondent upon request. In order to help ensure that a respondent has access to the evidence in support of OPR's position, as well as other evidence included in the investigatory file, the Treasury Department and IRS are considering ways in which the existing practice relating to the OPR administrative file can be formalized, and will consider addressing this issue in future published guidance. Supplemental Charges The final regulations adopt the rules on supplemental charges as proposed with minor revisions. Section 10.65 of the regulations provides that the Director of the Office of Professional Responsibility may file supplemental charges against a practitioner or appraiser by amending the complaint to reflect the additional charges if the practitioner or appraiser is given notice and an opportunity to prepare a defense to the supplemental charges. Discovery, Hearings, and Publicity of Proceedings The final regulations adopt the proposed changes to §§ 10.68, 10.71, and 10.72(a) through
(c)without modification. Most commentators supported expanding the use of discovery in disciplinary proceedings. Most commentators also supported providing further procedural protections such as a guarantee of the right to cross-examine witnesses. Section 10.71(f) of the final regulations provides that no discovery other than that specifically provided in that section is permitted. Section 10.72(d) regarding the publicity of disciplinary proceedings is adopted with modification. These final regulations provide that reports and decisions of the ALJ and appellate authority will be available for public inspection within 30 days after the agency's decision becomes final, subject to procedures to protect the identities of any third-party taxpayers. This publicity will provide greater transparency to the disciplinary process. Although most commentators do not oppose disclosure if a sanction is imposed, commentators raised concerns about disclosure before the Secretary's decision is final. The concerns are that premature public disclosure will unfairly tarnish practitioners' reputations and that IRS proceedings lack the independent review and system of checks and balances found in State bar disciplinary proceedings. Several commentators specifically requested that an independent party outside of the IRS make a probable cause determination prior to disclosure. Attorneys in the Office of Professional Responsibility review every allegation received by the office. If an allegation warrants investigation, the practitioner is provided with an opportunity to confer with the Office of Professional Responsibility regarding the allegation against the practitioner. After the conference, the Office of Professional Responsibility may close their investigation without action, or, if a violation of Circular 230 has occurred, attempt to reach an agreement with the practitioner on an appropriate sanction. If an agreement is not reached, the Office of Professional Responsibility sends the case to the Office of the Associate Chief Counsel (General Legal Services) for further action. An attorney in the Office of the Associate Chief Counsel (General Legal Services) thoroughly reviews the case file, and, if a violation of Circular 230 has occurred, the practitioner is offered one more opportunity to discuss the merits and settlement of the case before a formal complaint is filed. Only after the case has been reviewed by the Office of the Associate Chief Counsel (General Legal Services) and the practitioner has been offered this second opportunity to discuss and settle the case is a formal complaint filed. In light of the concerns raised by commentators that premature public disclosure could potentially tarnish practitioners' reputations, the final regulations require that disclosure of the disciplinary decision be delayed until after the decision becomes final. This modification ensures that there is no potential premature tarnishing of a practitioner's reputation. Decision of Administrative Law Judge The final regulations do not adopt the proposed rules under §§ 10.77 and 10.78, which provided for a more streamlined process for deciding appeals of the Administrative Law Judges' decisions. The intent of this streamlined process was to provide a more timely process for deciding appeals. Numerous concerns were raised with the streamlined process, and, after consideration of the concerns, these final regulations keep the current rules under §§ 10.77 and 10.78 in effect. But to achieve a more timely review of any appeal, the regulations now provide that the Secretary of the Treasury, or delegate, should make the agency decision within 180 days after receipt of the appeal. The failure of the Secretary of the Treasury, or delegate, to meet this timeframe, as well as any other discretionary timeframe in subpart D, does not create a right of action for the practitioner. Expedited Suspension The final regulations adopt, with modification, the proposed amendments to § 10.82. Final § 10.82 expands the authority of the Office of Professional Responsibility to institute expedited suspension proceedings against practitioners who advance frivolous or obstructionist positions (after a sanction by a court of competent jurisdiction). The Treasury Department and the IRS continue to believe that the expedited suspension process is equitable and appropriate in the limited listed circumstances. The Office of Professional Responsibility completes an investigation of the issues prior to instituting an expedited proceeding and practitioners are entitled to a conference with the Office of Professional Responsibility upon request. Several commentators expressed concern that expanding the authorized use of the expedited procedures to compliance cases further erodes a practitioner's rights to due process. After further consideration of this issue, final § 10.82 does not expand the authority of the Office of Professional Responsibility to institute expedited suspension proceedings against practitioners who are not in compliance with their own Federal tax obligations (failure to file or pay a tax in 3 of the preceding 5 years, or in 4 of the preceding 7 periods). Special Analyses It has been determined that this final rule is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It is hereby certified, under the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ), that these regulations will not have a significant economic impact on a substantial number of small entities. Persons authorized to practice have long been required to comply with certain standards of conduct when practicing before the Internal Revenue Service. These regulations do not alter the basic nature of the obligations and responsibilities of these practitioners. These regulations merely clarify those obligations in response to public comments, replace certain terminology to conform with the terminology used in 18 U.S.C. 207, and 5 CFR parts 2637 and 2641 (or superseding regulations), make modifications to reflect amendments to section 330 of title 31 made by the Jobs Act, and make other modifications to reflect concerns about greater independence, transparency and due process. These regulations will not impose, or otherwise cause, a significant increase in reporting, recordkeeping, or other compliance burdens on a substantial number of small entities. A regulatory flexibility analysis, therefore, is not required. Pursuant to section 7805(f) of the Internal Revenue Code, the notice of proposed rulemaking preceding these regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on the regulations' impact on small businesses. Drafting Information The principal author of these regulations is Matthew S. Cooper of the Office of the Associate Chief Counsel (Procedure and Administration). List of Subjects in 31 CFR Part 10 Accountants, Administrative practice and procedure, Lawyers, Reporting and recordkeeping requirements, Taxes. Adoption of Amendments to the Regulations Accordingly, 31 CFR part 10 is amended to read as follows: PART 10—PRACTICE BEFORE THE INTERNAL REVENUE SERVICE **Paragraph 1.** The authority citation for 31 CFR part 10 continues to read as follows: Authority: Sec. 3, 23 Stat. 258, secs. 2-12, 60 Stat. 237 et seq.; 5 U.S.C. 301, 500, 551-559; 31 U.S.C. 321; 31 U.S.C. 330; Reorg. Plan No. 26 of 1950, 15 FR 4935, 64 Stat. 1280, 3 CFR, 1949-1953 Comp., p. 1017. **Par. 2.** In Part 10, remove the language “Director of Practice” wherever it appears and add, in its place, the language “Director of the Office of Professional Responsibility” in each of the following sections and paragraphs: Section 10.5(c),
(d)and (e); Section 10.6(a)(5), (b), (g)(2)(iii), (g)(2)(iv), (g)(4), (j)(1), (j)(2), (j)(4), (k)(1), (k)(2) and (n); Section 10.7(c)(2)(iii) and (d); Section 10.20(b) heading,
(b)and (c); Section 10.60(b); Section 10.63(c) heading, (c); Section 10.64(a); Section 10.66; Section 10.69(a)(1) and (b); Section 10.73(a); Section 10.79(a), (b),
(c)and (d); Section 10.80; Section 10.81; Section 10.82(a),
(c)introductory text, (c)(3), (d), (e), (f)(1) and (g). **Par. 3.** Section 10.1 is revised to read as follows: § 10.1 Director of the Office of Professional Responsibility.
(a)*Establishment of office.* The Office of Professional Responsibility is established in the Internal Revenue Service. The Director of the Office of Professional Responsibility is appointed by the Secretary of the Treasury, or delegate.
(b)*Duties.* The Director of the Office of Professional Responsibility acts on applications for enrollment to practice before the Internal Revenue Service; makes inquiries with respect to matters under the Director's jurisdiction; institutes and provides for the conduct of disciplinary proceedings relating to practitioners (and employers, firms or other entities, if applicable) and appraisers; and performs other duties as are necessary or appropriate to carry out the functions under this part or as are otherwise prescribed by the Secretary of the Treasury, or delegate.
(c)*Acting Director of the Office of Professional Responsibility.* The Secretary of the Treasury, or delegate, will designate an officer or employee of the Treasury Department to act as Director of the Office of Professional Responsibility in the absence of the Director or during a vacancy in that office.
(d)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 4.** Section 10.2 is revised to read as follows: § 10.2 Definitions.
(a)As used in this part, except where the text provides otherwise—
(1)*Attorney* means any person who is a member in good standing of the bar of the highest court of any state, territory, or possession of the United States, including a Commonwealth, or the District of Columbia.
(2)*Certified public accountant* means any person who is duly qualified to practice as a certified public accountant in any state, territory, or possession of the United States, including a Commonwealth, or the District of Columbia.
(3)*Commissioner* refers to the Commissioner of Internal Revenue.
(4)*Practice before the Internal Revenue Service* comprehends all matters connected with a presentation to the Internal Revenue Service or any of its officers or employees relating to a taxpayer's rights, privileges, or liabilities under laws or regulations administered by the Internal Revenue Service. Such presentations include, but are not limited to, preparing and filing documents, corresponding and communicating with the Internal Revenue Service, rendering written advice with respect to any entity, transaction, plan or arrangement, or other plan or arrangement having a potential for tax avoidance or evasion, and representing a client at conferences, hearings and meetings.
(5)*Practitioner* means any individual described in paragraphs (a), (b), (c),
(d)or
(e)of § 10.3.
(6)A *tax return* includes an amended tax return and a claim for refund.
(7)*Service* means the Internal Revenue Service.
(b)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 5.** Section 10.3 is amended by:
(1)Revising paragraphs
(a)and (b).
(2)Redesignating paragraphs (e), (f), and
(g)as paragraphs (f), (g), and (h), respectively.
(3)Adding new paragraphs
(e)and (i). The revisions and additions read as follows: § 10.3 Who may practice.
(a)*Attorneys.* Any attorney who is not currently under suspension or disbarment from practice before the Internal Revenue Service may practice before the Internal Revenue Service by filing with the Internal Revenue Service a written declaration that the attorney is currently qualified as an attorney and is authorized to represent the party or parties. Notwithstanding the preceding sentence, attorneys who are not currently under suspension or disbarment from practice before the Internal Revenue Service are not required to file a written declaration with the IRS before rendering written advice covered under § 10.35 or § 10.37, but their rendering of this advice is practice before the Internal Revenue Service.
(b)*Certified public accountants.* Any certified public accountant who is not currently under suspension or disbarment from practice before the Internal Revenue Service may practice before the Internal Revenue Service by filing with the Internal Revenue Service a written declaration that the certified public accountant is currently qualified as a certified public accountant and is authorized to represent the party or parties. Notwithstanding the preceding sentence, certified public accountants who are not currently under suspension or disbarment from practice before the Internal Revenue Service are not required to file a written declaration with the IRS before rendering written advice covered under § 10.35 or § 10.37, but their rendering of this advice is practice before the Internal Revenue Service.
(e)*Enrolled Retirement Plan Agents* —(1) Any individual enrolled as a retirement plan agent pursuant to this part who is not currently under suspension or disbarment from practice before the Internal Revenue Service may practice before the Internal Revenue Service.
(2)Practice as an enrolled retirement plan agent is limited to representation with respect to issues involving the following programs: Employee Plans Determination Letter program; Employee Plans Compliance Resolution System; and Employee Plans Master and Prototype and Volume Submitter program. In addition, enrolled retirement plan agents are generally permitted to represent taxpayers with respect to IRS forms under the 5300 and 5500 series which are filed by retirement plans and plan sponsors, but not with respect to actuarial forms or schedules.
(3)An individual who practices before the Internal Revenue Service pursuant to paragraph (e)(1) of this section is subject to the provisions of this part in the same manner as attorneys, certified public accountants and enrolled agents.
(i)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 6.** Section 10.4 is revised to read as follows: § 10.4 Eligibility for enrollment as enrolled agent or enrolled retirement plan agent.
(a)*Enrollment as an enrolled agent upon examination.* The Director of the Office of Professional Responsibility may grant enrollment as an enrolled agent to an applicant who demonstrates special competence in tax matters by written examination administered by, or administered under the oversight of, the Director of the Office of Professional Responsibility and who has not engaged in any conduct that would justify the censure, suspension, or disbarment of any practitioner under the provisions of this part.
(b)*Enrollment as a retirement plan agent upon examination.* The Director of the Office of Professional Responsibility may grant enrollment as an enrolled retirement plan agent to an applicant who demonstrates special competence in qualified retirement plan matters by written examination administered by, or administered under the oversight of, the Director of the Office of Professional Responsibility and who has not engaged in any conduct that would justify the censure, suspension, or disbarment of any practitioner under the provisions of this part.
(c)*Enrollment of former Internal Revenue Service employees.* The Director of the Office of Professional Responsibility may grant enrollment as an enrolled agent or enrolled retirement plan agent to an applicant who, by virtue of past service and technical experience in the Internal Revenue Service, has qualified for such enrollment and who has not engaged in any conduct that would justify the censure, suspension, or disbarment of any practitioner under the provisions of this part, under the following circumstances—
(1)The former employee applies for enrollment to the Director of the Office of Professional Responsibility on a form supplied by the Director of the Office of Professional Responsibility and supplies the information requested on the form and such other information regarding the experience and training of the applicant as may be relevant.
(2)An appropriate office of the Internal Revenue Service, at the request of the Director of the Office of Professional Responsibility, will provide the Director of the Office of Professional Responsibility with a detailed report of the nature and rating of the applicant's work while employed by the Internal Revenue Service and a recommendation whether such employment qualifies the applicant technically or otherwise for the desired authorization.
(3)Enrollment as an enrolled agent based on an applicant's former employment with the Internal Revenue Service may be of unlimited scope or it may be limited to permit the presentation of matters only of the particular class or only before the particular unit or division of the Internal Revenue Service for which the applicant's former employment has qualified the applicant. Enrollment as an enrolled retirement plan agent based on an applicant's former employment with the Internal Revenue Service will be limited to permit the presentation of matters only with respect to qualified retirement plan matters.
(4)Application for enrollment as an enrolled agent or enrolled retirement plan agent based on an applicant's former employment with the Internal Revenue Service must be made within 3 years from the date of separation from such employment.
(5)An applicant for enrollment as an enrolled agent who is requesting such enrollment based on former employment with the Internal Revenue Service must have had a minimum of 5 years continuous employment with the Internal Revenue Service during which the applicant must have been regularly engaged in applying and interpreting the provisions of the Internal Revenue Code and the regulations relating to income, estate, gift, employment, or excise taxes.
(6)An applicant for enrollment as an enrolled retirement plan agent who is requesting such enrollment based on former employment with the Internal Revenue Service must have had a minimum of 5 years continuous employment with the Internal Revenue Service during which the applicant must have been regularly engaged in applying and interpreting the provisions of the Internal Revenue Code and the regulations relating to qualified retirement plan matters.
(7)For the purposes of paragraphs (b)(5) and (b)(6) of this section, an aggregate of 10 or more years of employment in positions involving the application and interpretation of the provisions of the Internal Revenue Code, at least 3 of which occurred within the 5 years preceding the date of application, is the equivalent of 5 years continuous employment.
(d)*Natural persons.* Enrollment to practice may be granted only to natural persons.
(e)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 7.** Section 10.5 is amended by revising the section heading and paragraphs
(a)and (b), and adding paragraph
(f)to read as follows: § 10.5 Application for enrollment as an enrolled agent or enrolled retirement plan agent.
(a)*Form; address.* An applicant for enrollment as an enrolled agent or enrolled retirement plan agent must apply as required by forms or procedures established and published by the Office of Professional Responsibility, including proper execution of required forms under oath or affirmation. The address on the application will be the address under which a successful applicant is enrolled and is the address to which all correspondence concerning enrollment will be sent.
(b)*Fee.* A reasonable nonrefundable fee will be charged for each application for enrollment as an enrolled agent filed with the Director of the Office of Professional Responsibility in accordance with 26 CFR 300.5. A reasonable nonrefundable fee will be charged for each application for enrollment as an enrolled retirement plan agent filed with the Director of the Office of Professional Responsibility.
(f)*Effective/applicability date.* This section is applicable to enrollment applications received on or after September 26, 2007. **Par. 8.** Section 10.6 is amended by: 1. Revising the section heading. 2. Removing paragraph (a). 3. Redesignating paragraph
(c)as paragraph (a). 4. Adding new paragraphs
(c)and (p). 5. Revising paragraphs
(d)introductory text, (d)(4), (d)(5), (d)(6), (d)(7), (e), (f)(1), (f)(2)(iv)(A), (g)(5), (k)(4), (k)(7) and (l). The revisions and additions read as follows: § 10.6 Enrollment as an enrolled agent or enrolled retirement plan agent.
(c)*Change of address.* An enrolled agent or enrolled retirement plan agent must send notification of any change of address to the address specified by the Director of the Office of Professional Responsibility. This notification must include the enrolled agent's or enrolled retirement plan agent's name, prior address, new address, social security number or tax identification number and the date.
(d)*Renewal of enrollment.* To maintain active enrollment to practice before the Internal Revenue Service, each individual is required to have the enrollment renewed. Failure to receive notification from the Director of the Office of Professional Responsibility of the renewal requirement will not be justification for the individual's failure to satisfy this requirement.
(4)Thereafter, applications for renewal as an enrolled agent will be required between November 1 and January 31 of every subsequent third year as specified in paragraph (d)(1),
(2)or
(3)of this section according to the last number of the individual's social security number or tax identification number. Those individuals who receive initial enrollment as an enrolled agent after November 1 and before April 2 of the applicable renewal period will not be required to renew their enrollment before the first full renewal period following the receipt of their initial enrollment. Applications for renewal as an enrolled retirement plan agent will be required of all enrolled retirement plan agents between April 1 and June 30 of every third year period subsequent to their initial enrollment.
(5)The Director of the Office of Professional Responsibility will notify the individual of the renewal of enrollment and will issue the individual a card evidencing enrollment.
(6)A reasonable nonrefundable fee will be charged for each application for renewal of enrollment as an enrolled agent filed with the Director of the Office of Professional Responsibility in accordance with 26 CFR 300.6. A reasonable nonrefundable fee will be charged for each application for renewal of enrollment as an enrolled retirement plan agent filed with the Director of the Office of Professional Responsibility.
(7)Forms required for renewal may be obtained by sending a written request to the Director of the Office of Professional Responsibility, Internal Revenue Service, 1111 Constitution Avenue, NW., Washington, DC 20224 or from such other source as the Director of the Office of Professional Responsibility will publish in the Internal Revenue Bulletin (see 26 CFR 601.601(d)(2)(ii)( *b* )) and on the Internal Revenue Service Web page ( *http://www.irs.gov* ).
(e)*Condition for renewal: Continuing professional education.* In order to qualify for renewal of enrollment, an individual enrolled to practice before the Internal Revenue Service must certify, on the application for renewal form prescribed by the Director of the Office of Professional Responsibility, that he or she has satisfied the following continuing professional education requirements.
(1)*Definitions.* For purposes of this section—
(i)*Enrollment year* means January 1 to December 31 of each year of an enrollment cycle.
(ii)*Enrollment cycle* means the three successive enrollment years preceding the effective date of renewal.
(iii)The *effective date of renewal* is the first day of the fourth month following the close of the period for renewal described in paragraph
(d)of this section.
(2)*For renewed enrollment effective after December 31, 2006—(i) Requirements for enrollment cycle.* A minimum of 72 hours of continuing education credit must be completed during each enrollment cycle.
(ii)*Requirements for enrollment year.* A minimum of 16 hours of continuing education credit, including 2 hours of ethics or professional conduct, must be completed during each enrollment year of an enrollment cycle.
(iii)*Enrollment during enrollment cycle* —(A) *In general.* Subject to paragraph (e)(2)(iii)(B) of this section, an individual who receives initial enrollment during an enrollment cycle must complete 2 hours of qualifying continuing education credit for each month enrolled during the enrollment cycle. Enrollment for any part of a month is considered enrollment for the entire month.
(B)*Ethics.* An individual who receives initial enrollment during an enrollment cycle must complete 2 hours of ethics or professional conduct for each enrollment year during the enrollment cycle. Enrollment for any part of an enrollment year is considered enrollment for the entire year.
(f)*Qualifying continuing education* —(1) *General* —(i) *Enrolled agents.* To qualify for continuing education credit for an enrolled agent, a course of learning must—
(A)Be a qualifying program designed to enhance professional knowledge in Federal taxation or Federal tax related matters (programs comprised of current subject matter in Federal taxation or Federal tax related matters, including accounting, tax preparation software and taxation or ethics);
(B)Be a qualifying program consistent with the Internal Revenue Code and effective tax administration; and
(C)Be sponsored by a qualifying sponsor.
(ii)*Enrolled retirement plan agents.* To qualify for continuing education credit for an enrolled retirement plan agent, a course of learning must—
(i)Be a qualifying program designed to enhance professional knowledge in qualified retirement plan matters;
(ii)Be a qualifying program consistent with the Internal Revenue Code and effective tax administration; and
(iii)Be sponsored by a qualifying sponsor.
(2)* * *
(iv)*Credit for published articles, books, etc.*
(A)For enrolled agents, continuing education credit will be awarded for publications on Federal taxation or Federal tax related matters, including accounting, tax preparation software, and taxation or ethics, provided the content of such publications is current and designed for the enhancement of the professional knowledge of an individual enrolled to practice before the Internal Revenue Service. The publication must be consistent with the Internal Revenue Code and effective tax administration. For enrolled retirement plan agents, continuing education credit will be awarded for publications on qualified retirement plan matters, provided the content of such publications is current and designed for the enhancement of the professional knowledge of an individual enrolled to practice as an enrolled retirement plan agent before the Internal Revenue Service. The publication must be consistent with the Internal Revenue Code and effective tax administration.
(g)* * *
(5)*Sponsor renewal* —(i) *In general.* A sponsor maintains its status as a qualified sponsor during the sponsor enrollment cycle.
(ii)*Renewal period.* Each sponsor must file an application to renew its status as a qualified sponsor between May 1 and July 31, 2008. Thereafter, applications for renewal will be required between May 1 and July 31 of every subsequent third year.
(iii)*Effective date of renewal.* The effective date of renewal is the first day of the third month following the close of the renewal period.
(iv)*Sponsor enrollment cycle.* The sponsor enrollment cycle is the three successive calendar years preceding the effective date of renewal.
(k)* * *
(4)Individuals placed in inactive enrollment status and individuals ineligible to practice before the Internal Revenue Service may not state or imply that they are enrolled to practice before the Internal Revenue Service, or use the terms enrolled agent or enrolled retirement plan agent, the designations “EA” or “ERPA” or other form of reference to eligibility to practice before the Internal Revenue Service.
(7)Inactive enrollment status is not available to an individual who is the subject of a disciplinary matter in the Office of Professional Responsibility.
(l)*Inactive retirement status.* An individual who no longer practices before the Internal Revenue Service may request being placed in an inactive retirement status at any time and such individual will be placed in an inactive retirement status. The individual will be ineligible to practice before the Internal Revenue Service. Such individual must file a timely application for renewal of enrollment at each applicable renewal or enrollment period as provided in this section. An individual who is placed in an inactive retirement status may be reinstated to an active enrollment status by filing an application for renewal of enrollment and providing evidence of the completion of the required continuing professional education hours for the enrollment cycle. Inactive retirement status is not available to an individual who is the subject of a disciplinary matter in the Office of Professional Responsibility.
(p)*Effective/applicability date.* This section is applicable to enrollment effective on or after September 26, 2007. **Par. 9.** Section 10.7 is amended by: 1. Revising paragraph (c)(2)(ii). 2. And adding paragraph (g). The revisions and additions read as follows: § 10.7 Representing oneself; participating in rulemaking; limited practice; special appearances; and return preparation.
(c)* * *
(2)* * *
(ii)The Director, after notice and opportunity for a conference, may deny eligibility to engage in limited practice before the Internal Revenue Service under paragraph (c)(1) of this section to any individual who has engaged in conduct that would justify a sanction under § 10.50.
(g)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 10.** Section 10.22 is amended by revising paragraph
(b)and adding paragraph
(c)to read as follows: § 10.22 Diligence as to accuracy.
(b)*Reliance on others.* Except as provided in §§ 10.34, 10.35, and 10.37, a practitioner will be presumed to have exercised due diligence for purposes of this section if the practitioner relies on the work product of another person and the practitioner used reasonable care in engaging, supervising, training, and evaluating the person, taking proper account of the nature of the relationship between the practitioner and the person.
(c)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 11.** Section 10.25 is revised to read as follows: § 10.25 Practice by former government employees, their partners and their associates.
(a)*Definitions.* For purposes of this section—
(1)*Assist* means to act in such a way as to advise, furnish information to, or otherwise aid another person, directly, or indirectly.
(2)*Government employee* is an officer or employee of the United States or any agency of the United States, including a special Government employee as defined in 18 U.S.C. 202(a), or of the District of Columbia, or of any State, or a member of Congress or of any State legislature.
(3)*Member of a firm* is a sole practitioner or an employee or associate thereof, or a partner, stockholder, associate, affiliate or employee of a partnership, joint venture, corporation, professional association or other affiliation of two or more practitioners who represent nongovernmental parties.
(4)*Particular matter involving specific parties* is defined at 5 CFR 2637.201(c), or superseding post-employment regulations issued by the U.S. Office of Government Ethics.
(5)*Rule* includes Treasury regulations, whether issued or under preparation for issuance as notices of proposed rulemaking or as Treasury decisions, revenue rulings, and revenue procedures published in the Internal Revenue Bulletin (see 26 CFR 601.601(d)(2)(ii)( *b* )).
(b)*General rules* —(1) No former Government employee may, subsequent to Government employment, represent anyone in any matter administered by the Internal Revenue Service if the representation would violate 18 U.S.C. 207 or any other laws of the United States.
(2)No former Government employee who personally and substantially participated in a particular matter involving specific parties may, subsequent to Government employment, represent or knowingly assist, in that particular matter, any person who is or was a specific party to that particular matter.
(3)A former Government employee who within a period of one year prior to the termination of Government employment had official responsibility for a particular matter involving specific parties may not, within two years after Government employment is ended, represent in that particular matter any person who is or was a specific party to that particular matter.
(4)No former Government employee may, within one year after Government employment is ended, communicate with or appear before, with the intent to influence, any employee of the Treasury Department in connection with the publication, withdrawal, amendment, modification, or interpretation of a rule the development of which the former Government employee participated in, or for which, within a period of one year prior to the termination of Government employment, the former government employee had official responsibility. This paragraph (b)(4) does not, however, preclude any former employee from appearing on one's own behalf or from representing a taxpayer before the Internal Revenue Service in connection with a particular matter involving specific parties involving the application or interpretation of a rule with respect to that particular matter, provided that the representation is otherwise consistent with the other provisions of this section and the former employee does not utilize or disclose any confidential information acquired by the former employee in the development of the rule.
(c)*Firm representation* —(1) No member of a firm of which a former Government employee is a member may represent or knowingly assist a person who was or is a specific party in any particular matter with respect to which the restrictions of paragraph (b)(2) of this section apply to the former Government employee, in that particular matter, unless the firm isolates the former Government employee in such a way to ensure that the former Government employee cannot assist in the representation.
(2)When isolation of a former Government employee is required under paragraph (c)(1) of this section, a statement affirming the fact of such isolation must be executed under oath by the former Government employee and by another member of the firm acting on behalf of the firm. The statement must clearly identify the firm, the former Government employee, and the particular matter(s) requiring isolation. The statement must be retained by the firm and, upon request, provided to the Director of the Office of Professional Responsibility.
(d)*Pending representation.* The provisions of this regulation will govern practice by former Government employees, their partners and associates with respect to representation in particular matters involving specific parties where actual representation commenced before the effective date of this regulation.
(e)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 12.** Section 10.27 is revised to read as follows: § 10.27 Fees.
(a)*In general.* A practitioner may not charge an unconscionable fee in connection with any matter before the Internal Revenue Service.
(b)*Contingent fees* —(1) Except as provided in paragraphs (b)(2), (3), and
(4)of this section, a practitioner may not charge a contingent fee for services rendered in connection with any matter before the Internal Revenue Service.
(2)A practitioner may charge a contingent fee for services rendered in connection with the Service's examination of, or challenge to—
(i)An original tax return; or
(ii)An amended return or claim for refund or credit where the amended return or claim for refund or credit was filed within 120 days of the taxpayer receiving a written notice of the examination of, or a written challenge to the original tax return.
(3)A practitioner may charge a contingent fee for services rendered in connection with a claim for credit or refund filed solely in connection with the determination of statutory interest or penalties assessed by the Internal Revenue Service.
(4)A practitioner may charge a contingent fee for services rendered in connection with any judicial proceeding arising under the Internal Revenue Code.
(c)*Definitions.* For purposes of this section—
(1)*Contingent fee* is any fee that is based, in whole or in part, on whether or not a position taken on a tax return or other filing avoids challenge by the Internal Revenue Service or is sustained either by the Internal Revenue Service or in litigation. A contingent fee includes a fee that is based on a percentage of the refund reported on a return, that is based on a percentage of the taxes saved, or that otherwise depends on the specific result attained. A contingent fee also includes any fee arrangement in which the practitioner will reimburse the client for all or a portion of the client's fee in the event that a position taken on a tax return or other filing is challenged by the Internal Revenue Service or is not sustained, whether pursuant to an indemnity agreement, a guarantee, rescission rights, or any other arrangement with a similar effect.
(2)*Matter before the Internal Revenue Service* includes tax planning and advice, preparing or filing or assisting in preparing or filing returns or claims for refund or credit, and all matters connected with a presentation to the Internal Revenue Service or any of its officers or employees relating to a taxpayer's rights, privileges, or liabilities under laws or regulations administered by the Internal Revenue Service. Such presentations include, but are not limited to, preparing and filing documents, corresponding and communicating with the Internal Revenue Service, rendering written advice with respect to any entity, transaction, plan or arrangement, and representing a client at conferences, hearings, and meetings.
(d)*Effective/applicability date.* This section is applicable for fee arrangements entered into after March 26, 2008. **Par. 13.** Section 10.29 is revised to read as follows: § 10.29 Conflicting interests.
(a)Except as provided by paragraph
(b)of this section, a practitioner shall not represent a client before the Internal Revenue Service if the representation involves a conflict of interest. A conflict of interest exists if—
(1)The representation of one client will be directly adverse to another client; or
(2)There is a significant risk that the representation of one or more clients will be materially limited by the practitioner's responsibilities to another client, a former client or a third person, or by a personal interest of the practitioner.
(b)Notwithstanding the existence of a conflict of interest under paragraph
(a)of this section, the practitioner may represent a client if—
(1)The practitioner reasonably believes that the practitioner will be able to provide competent and diligent representation to each affected client;
(2)The representation is not prohibited by law; and
(3)Each affected client waives the conflict of interest and gives informed consent, confirmed in writing by each affected client, at the time the existence of the conflict of interest is known by the practitioner. The confirmation may be made within a reasonable period after the informed consent, but in no event later than 30 days.
(c)Copies of the written consents must be retained by the practitioner for at least 36 months from the date of the conclusion of the representation of the affected clients, and the written consents must be provided to any officer or employee of the Internal Revenue Service on request.
(d)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 14.** In § 10.30, paragraph (a)(1) is revised and paragraph
(e)is added to read as follows: § 10.30 Solicitation.
(a)*Advertising and solicitation restrictions.*
(1)A practitioner may not, with respect to any Internal Revenue Service matter, in any way use or participate in the use of any form or public communication or private solicitation containing a false, fraudulent, or coercive statement or claim; or a misleading or deceptive statement or claim. Enrolled agents or enrolled retirement plan agents, in describing their professional designation, may not utilize the term of art “certified” or imply an employer/employee relationship with the Internal Revenue Service. Examples of acceptable descriptions for enrolled agents are “enrolled to represent taxpayers before the Internal Revenue Service,” “enrolled to practice before the Internal Revenue Service,” and “admitted to practice before the Internal Revenue Service.” Similarly, examples of acceptable descriptions for enrolled retirement plan agents are “enrolled to represent taxpayers before the Internal Revenue Service as a retirement plan agent” and “enrolled to practice before the Internal Revenue Service as a retirement plan agent.”
(e)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 15.** Section 10.34 is revised to read as follows: § 10.34 Standards with respect to tax returns and documents, affidavits and other papers.
(a)[Reserved].
(b)*Documents, affidavits and other papers* —(1) A practitioner may not advise a client to take a position on a document, affidavit or other paper submitted to the Internal Revenue Service unless the position is not frivolous.
(2)A practitioner may not advise a client to submit a document, affidavit or other paper to the Internal Revenue Service—
(i)The purpose of which is to delay or impede the administration of the Federal tax laws;
(ii)That is frivolous; or
(iii)That contains or omits information in a manner that demonstrates an intentional disregard of a rule or regulation unless the practitioner also advises the client to submit a document that evidences a good faith challenge to the rule or regulation.
(c)*Advising clients on potential penalties* —(1) A practitioner must inform a client of any penalties that are reasonably likely to apply to the client with respect to—
(i)A position taken on a tax return if—
(A)The practitioner advised the client with respect to the position; or
(B)The practitioner prepared or signed the tax return; and
(ii)Any document, affidavit or other paper submitted to the Internal Revenue Service.
(2)The practitioner also must inform the client of any opportunity to avoid any such penalties by disclosure, if relevant, and of the requirements for adequate disclosure.
(3)This paragraph
(c)applies even if the practitioner is not subject to a penalty under the Internal Revenue Code with respect to the position or with respect to the document, affidavit or other paper submitted.
(d)*Relying on information furnished by clients.* A practitioner advising a client to take a position on a tax return, document, affidavit or other paper submitted to the Internal Revenue Service, or preparing or signing a tax return as a preparer, generally may rely in good faith without verification upon information furnished by the client. The practitioner may not, however, ignore the implications of information furnished to, or actually known by, the practitioner, and must make reasonable inquiries if the information as furnished appears to be incorrect, inconsistent with an important fact or another factual assumption, or incomplete.
(e)[Reserved].
(f)*Effective/applicability date.* Section 10.34 is applicable to tax returns, documents, affidavits and other papers filed on or after September 26, 2007. **Par. 16.** In § 10.35(b)(1) remove the language “§ 10.2(e)” and add the language “§ 10.2(a)(5)” in its place. **Par. 17.** Section 10.50 is revised to read as follows: § 10.50 Sanctions.
(a)*Authority to censure, suspend, or disbar.* The Secretary of the Treasury, or delegate, after notice and an opportunity for a proceeding, may censure, suspend, or disbar any practitioner from practice before the Internal Revenue Service if the practitioner is shown to be incompetent or disreputable (within the meaning of § 10.51), fails to comply with any regulation in this part (under the prohibited conduct standards of § 10.52), or with intent to defraud, willfully and knowingly misleads or threatens a client or prospective client. Censure is a public reprimand.
(b)*Authority to disqualify.* The Secretary of the Treasury, or delegate, after due notice and opportunity for hearing, may disqualify any appraiser for a violation of these rules as applicable to appraisers.
(1)If any appraiser is disqualified pursuant to this subpart C, the appraiser is barred from presenting evidence or testimony in any administrative proceeding before the Department of the Treasury or the Internal Revenue Service, unless and until authorized to do so by the Director of the Office of Professional Responsibility pursuant to § 10.81, regardless of whether the evidence or testimony would pertain to an appraisal made prior to or after the effective date of disqualification.
(2)Any appraisal made by a disqualified appraiser after the effective date of disqualification will not have any probative effect in any administrative proceeding before the Department of the Treasury or the Internal Revenue Service. An appraisal otherwise barred from admission into evidence pursuant to this section may be admitted into evidence solely for the purpose of determining the taxpayer's reliance in good faith on such appraisal.
(c)*Authority to impose monetary penalty* —(1) *In general.*
(i)The Secretary of the Treasury, or delegate, after notice and an opportunity for a proceeding, may impose a monetary penalty on any practitioner who engages in conduct subject to sanction under paragraph
(a)of this section.
(ii)If the practitioner described in paragraph (c)(1)(i) of this section was acting on behalf of an employer or any firm or other entity in connection with the conduct giving rise to the penalty, the Secretary of the Treasury, or delegate, may impose a monetary penalty on the employer, firm, or entity if it knew, or reasonably should have known, of such conduct.
(2)*Amount of penalty.* The amount of the penalty shall not exceed the gross income derived (or to be derived) from the conduct giving rise to the penalty.
(3)*Coordination with other sanctions.* Subject to paragraph (c)(2) of this section—
(i)Any monetary penalty imposed on a practitioner under this paragraph
(c)may be in addition to or in lieu of any suspension, disbarment or censure and may be in addition to a penalty imposed on an employer, firm or other entity under paragraph (c)(1)(ii) of this section.
(ii)Any monetary penalty imposed on an employer, firm or other entity may be in addition to or in lieu of penalties imposed under paragraph (c)(1)(i) of this section.
(d)*Sanctions to be imposed.* The sanctions imposed by this section shall take into account all relevant facts and circumstances.
(e)*Effective/applicability date.* This section is applicable to conduct occurring on or after September 26, 2007, except paragraph
(c)which applies to prohibited conduct that occurs after October 22, 2004. **Par. 18.** Section 10.51 is revised to read as follows: § 10.51 Incompetence and disreputable conduct.
(a)*Incompetence and disreputable conduct.* Incompetence and disreputable conduct for which a practitioner may be sanctioned under § 10.50 includes, but is not limited to—
(1)Conviction of any criminal offense under the Federal tax laws.
(2)Conviction of any criminal offense involving dishonesty or breach of trust.
(3)Conviction of any felony under Federal or State law for which the conduct involved renders the practitioner unfit to practice before the Internal Revenue Service.
(4)Giving false or misleading information, or participating in any way in the giving of false or misleading information to the Department of the Treasury or any officer or employee thereof, or to any tribunal authorized to pass upon Federal tax matters, in connection with any matter pending or likely to be pending before them, knowing the information to be false or misleading. Facts or other matters contained in testimony, Federal tax returns, financial statements, applications for enrollment, affidavits, declarations, and any other document or statement, written or oral, are included in the term “information.”
(5)Solicitation of employment as prohibited under § 10.30, the use of false or misleading representations with intent to deceive a client or prospective client in order to procure employment, or intimating that the practitioner is able improperly to obtain special consideration or action from the Internal Revenue Service or any officer or employee thereof.
(6)Willfully failing to make a Federal tax return in violation of the Federal tax laws, or willfully evading, attempting to evade, or participating in any way in evading or attempting to evade any assessment or payment of any Federal tax.
(7)Willfully assisting, counseling, encouraging a client or prospective client in violating, or suggesting to a client or prospective client to violate, any Federal tax law, or knowingly counseling or suggesting to a client or prospective client an illegal plan to evade Federal taxes or payment thereof.
(8)Misappropriation of, or failure properly or promptly to remit, funds received from a client for the purpose of payment of taxes or other obligations due the United States.
(9)Directly or indirectly attempting to influence, or offering or agreeing to attempt to influence, the official action of any officer or employee of the Internal Revenue Service by the use of threats, false accusations, duress or coercion, by the offer of any special inducement or promise of an advantage, or by the bestowing of any gift, favor or thing of value.
(10)Disbarment or suspension from practice as an attorney, certified public accountant, public accountant or actuary by any duly constituted authority of any State, territory, or possession of the United States, including a Commonwealth, or the District of Columbia, any Federal court of record or any Federal agency, body or board.
(11)Knowingly aiding and abetting another person to practice before the Internal Revenue Service during a period of suspension, disbarment or ineligibility of such other person.
(12)Contemptuous conduct in connection with practice before the Internal Revenue Service, including the use of abusive language, making false accusations or statements, knowing them to be false or circulating or publishing malicious or libelous matter.
(13)Giving a false opinion, knowingly, recklessly, or through gross incompetence, including an opinion which is intentionally or recklessly misleading, or engaging in a pattern of providing incompetent opinions on questions arising under the Federal tax laws. False opinions described in this paragraph (a)(13) include those which reflect or result from a knowing misstatement of fact or law, from an assertion of a position known to be unwarranted under existing law, from counseling or assisting in conduct known to be illegal or fraudulent, from concealing matters required by law to be revealed, or from consciously disregarding information indicating that material facts expressed in the opinion or offering material are false or misleading. For purposes of this paragraph (a)(13), reckless conduct is a highly unreasonable omission or misrepresentation involving an extreme departure from the standards of ordinary care that a practitioner should observe under the circumstances. A pattern of conduct is a factor that will be taken into account in determining whether a practitioner acted knowingly, recklessly, or through gross incompetence. Gross incompetence includes conduct that reflects gross indifference, preparation which is grossly inadequate under the circumstances, and a consistent failure to perform obligations to the client.
(14)Willfully failing to sign a tax return prepared by the practitioner when the practitioner's signature is required by the Federal tax laws unless the failure is due to reasonable cause and not due to willful neglect.
(15)Willfully disclosing or otherwise using a tax return or tax return information in a manner not authorized by the Internal Revenue Code, contrary to the order of a court of competent jurisdiction, or contrary to the order of an administrative law judge in a proceeding instituted under § 10.60.
(b)*Effective/applicability date.* This section is applicable to conduct occurring on or after September 26, 2007. Par. 19. Section 10.52 is revised to read as follows: § 10.52 Violations subject to sanction.
(a)A practitioner may be sanctioned under § 10.50 if the practitioner—
(1)Willfully violates any of the regulations (other than § 10.33) contained in this part; or
(2)Recklessly or through gross incompetence (within the meaning of § 10.51(a)(13)) violates §§ 10.34, 10.35, 10.36 or 10.37.
(b)*Effective/applicability date.* This section is applicable to conduct occurring on or after September 26, 2007. **Par. 20.** Section 10.53 is revised to read as follows: § 10.53 Receipt of information concerning practitioner.
(a)*Officer or employee of the Internal Revenue Service.* If an officer or employee of the Internal Revenue Service has reason to believe that a practitioner has violated any provision of this part, the officer or employee will promptly make a written report to the Director of the Office of Professional Responsibility of the suspected violation. The report will explain the facts and reasons upon which the officer's or employee's belief rests.
(b)*Other persons.* Any person other than an officer or employee of the Internal Revenue Service having information of a violation of any provision of this part may make an oral or written report of the alleged violation to the Director of the Office of Professional Responsibility or any officer or employee of the Internal Revenue Service. If the report is made to an officer or employee of the Internal Revenue Service, the officer or employee will make a written report of the suspected violation to the Director of the Office of Professional Responsibility.
(c)*Destruction of report.* No report made under paragraph
(a)or
(b)of this section shall be maintained by the Director of the Office of Professional Responsibility unless retention of the report is permissible under the applicable records control schedule as approved by the National Archives and Records Administration and designated in the Internal Revenue Manual. The Director of the Office of Professional Responsibility must destroy the reports as soon as permissible under the applicable records control schedule.
(d)*Effect on proceedings under subpart D.* The destruction of any report will not bar any proceeding under subpart D of this part, but will preclude the Director of the Office of Professional Responsibility's use of a copy of the report in a proceeding under subpart D of this part.
(e)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 21.** Section 10.60 is amended by revising paragraph
(a)and adding paragraph
(d)to read as follows: § 10.60 Institution of proceeding.
(a)Whenever the Director of the Office of Professional Responsibility determines that a practitioner (or employer, firm or other entity, if applicable) violated any provision of the laws governing practice before the Internal Revenue Service or the regulations in this part, the Director of the Office of Professional Responsibility may reprimand the practitioner or, in accordance with § 10.62, institute a proceeding for a sanction described in § 10.50. A proceeding is instituted by the filing of a complaint, the contents of which are more fully described in § 10.62.
(d)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 22.** Section 10.61 is revised to read as follows: § 10.61 Conferences.
(a)*In general.* The Director of the Office of Professional Responsibility may confer with a practitioner, employer, firm or other entity, or an appraiser concerning allegations of misconduct irrespective of whether a proceeding has been instituted. If the conference results in a stipulation in connection with an ongoing proceeding in which the practitioner, employer, firm or other entity, or appraiser is the respondent, the stipulation may be entered in the record by either party to the proceeding.
(b)*Voluntary sanction* —(1) *In general.* In lieu of a proceeding being instituted or continued under § 10.60(a), a practitioner or appraiser (or employer, firm or other entity, if applicable) may offer a consent to be sanctioned under § 10.50.
(2)*Discretion; acceptance or declination.* The Director of the Office of Professional Responsibility may, in his or her discretion, accept or decline the offer described in paragraph (b)(1) of this section. In any declination, the Director of the Office of Professional Responsibility may state that he or she would accept the offer described in paragraph (b)(1) of this section if it contained different terms. The Director of the Office of Professional Responsibility may, in his or her discretion, accept or reject a revised offer submitted in response to the declination or may counteroffer and act upon any accepted counteroffer.
(c)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 23.** Section 10.62 is revised to read as follows: § 10.62 Contents of complaint.
(a)*Charges.* A complaint must name the respondent, provide a clear and concise description of the facts and law that constitute the basis for the proceeding, and be signed by the Director of the Office of Professional Responsibility or a person representing the Director of the Office of Professional Responsibility under § 10.69(a)(1). A complaint is sufficient if it fairly informs the respondent of the charges brought so that the respondent is able to prepare a defense.
(b)*Specification of sanction.* The complaint must specify the sanction sought by the Director of the Office of Professional Responsiblity against the practitioner or appraiser. If the sanction sought is a suspension, the duration of the suspension sought must be specified.
(c)*Demand for answer.* The Director of the Office of Professional Responsibility must, in the complaint or in a separate paper attached to the complaint, notify the respondent of the time for answering the complaint, which may not be less than 30 days from the date of service of the complaint, the name and address of the Administrative Law Judge with whom the answer must be filed, the name and address of the person representing the Director of the Office of Professional Responsibility to whom a copy of the answer must be served, and that a decision by default may be rendered against the respondent in the event an answer is not filed as required.
(d)*Effective/applicability date.* This section is applicable to complaints brought on or after September 26, 2007. **Par. 24.** Section 10.63 is amended by: 1. Revising the section heading and paragraph (a)(4). 2. Redesignating paragraph
(d)as paragraph (e). 3. Adding new paragraphs
(d)and (f). The revision and additions read as follows: § 10.63 Service of complaint; service of other papers; service of evidence in support of complaint; filing of papers.
(a)* * *
(4)For purposes of this section, *respondent* means the practitioner, employer, firm or other entity, or appraiser named in the complaint or any other person having the authority to accept mail on behalf of the practitioner, employer, firm or other entity, or appraiser.
(d)*Service of evidence in support of complaint.* Within 10 days of serving the complaint, copies of the evidence in support of the complaint must be served on the respondent in any manner described in paragraphs (a)(2) and
(3)of this section.
(f)*Effective/applicability date.* This section is applicable to complaints brought on or after September 26, 2007. **Par. 25.** Section 10.65 is revised to read as follows: § 10.65 Supplemental charges.
(a)*In general.* The Director of the Office of Professional Responsibility may file supplemental charges, by amending the complaint with the permission of the Administrative Law Judge, against the respondent, if, for example—
(1)It appears that the respondent, in the answer, falsely and in bad faith, denies a material allegation of fact in the complaint or states that the respondent has insufficient knowledge to form a belief, when the respondent possesses such information; or
(2)It appears that the respondent has knowingly introduced false testimony during the proceedings against the respondent.
(b)*Hearing.* The supplemental charges may be heard with other charges in the case, provided the respondent is given due notice of the charges and is afforded a reasonable opportunity to prepare a defense to the supplemental charges.
(c)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 26.** Section 10.68 is revised to read as follows: § 10.68 Motions and requests.
(a)*Motions* —(1) *In general.* At any time after the filing of the complaint, any party may file a motion with the Administrative Law Judge. Unless otherwise ordered by the Administrative Law Judge, motions must be in writing and must be served on the opposing party as provided in § 10.63(b). A motion must concisely specify its grounds and the relief sought, and, if appropriate, must contain a memorandum of facts and law in support.
(2)*Summary adjudication.* Either party may move for a summary adjudication upon all or any part of the legal issues in controversy. If the non-moving party opposes summary adjudication in the moving party's favor, the non-moving party must file a written response within 30 days unless ordered otherwise by the Administrative Law Judge.
(3)*Good Faith.* A party filing a motion for extension of time, a motion for postponement of a hearing, or any other non-dispositive or procedural motion must first contact the other party to determine whether there is any objection to the motion, and must state in the motion whether the other party has an objection.
(b)*Response.* Unless otherwise ordered by the Administrative Law Judge, the nonmoving party is not required to file a response to a motion. If the Administrative Law Judge does not order the nonmoving party to file a response, and the nonmoving party files no response, the nonmoving party is deemed to oppose the motion. If a nonmoving party does not respond within 30 days of the filing of a motion for decision by default for failure to file a timely answer or for failure to prosecute, the nonmoving party is deemed not to oppose the motion.
(c)*Oral motions; oral argument* —(1) The Administrative Law Judge may, for good cause and with notice to the parties, permit oral motions and oral opposition to motions.
(2)The Administrative Law Judge may, within his or her discretion, permit oral argument on any motion.
(d)*Orders.* The Administrative Law Judge should issue written orders disposing of any motion or request and any response thereto.
(e)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 27.** Section 10.70 is amended by revising paragraphs
(a)and (b)(6) and adding paragraph
(c)to read as follows: § 10.70 Administrative Law Judge.
(a)*Appointment.* Proceedings on complaints for the sanction (as described in § 10.50) of a practitioner, employer, firm or other entity, or appraiser will be conducted by an Administrative Law Judge appointed as provided by 5 U.S.C. 3105.
(b)* * *
(6)Take or authorize the taking of depositions or answers to requests for admission;
(c)*Effective/applicability date.* This section is applicable on September 26, 2007. § 10.73 [Removed] **Par. 28a.** Section 10.73 is removed. **Par. 28b.** Sections 10.71 and 10.72 are redesignated as §§ 10.72 and 10.73, respectively. **Par. 29.** New § 10.71 is added to read as follows: § 10.71 Discovery.
(a)*In general.* Discovery may be permitted, at the discretion of the Administrative Law Judge, only upon written motion demonstrating the relevance, materiality and reasonableness of the requested discovery and subject to the requirements of § 10.72(d)(2) and (3). Within 10 days of receipt of the answer, the Administrative Law Judge will notify the parties of the right to request discovery and the timeframes for filing a request. A request for discovery, and objections, must be filed in accordance with § 10.68. In response to a request for discovery, the Administrative Law Judge may order—
(1)Depositions upon oral examination; or
(2)Answers to requests for admission.
(b)*Depositions upon oral examination* —(1) A deposition must be taken before an officer duly authorized to administer an oath for general purposes or before an officer or employee of the Internal Revenue Service who is authorized to administer an oath in Federal tax law matters.
(2)In ordering a deposition, the Administrative Law Judge will require reasonable notice to the opposing party as to the time and place of the deposition. The opposing party, if attending, will be provided the opportunity for full examination and cross-examination of any witness.
(3)Expenses in the reporting of depositions shall be borne by the party at whose instance the deposition is taken. Travel expenses of the deponent shall be borne by the party requesting the deposition, unless otherwise authorized by Federal law or regulation.
(c)*Requests for admission.* Any party may serve on any other party a written request for admission of the truth of any matters which are not privileged and are relevant to the subject matter of this proceeding. Requests for admission shall not exceed a total of 30 (including any subparts within a specific request) without the approval from the Administrative Law Judge.
(d)*Limitations.* Discovery shall not be authorized if—
(1)The request fails to meet any requirement set forth in paragraph
(a)of this section;
(2)It will unduly delay the proceeding;
(3)It will place an undue burden on the party required to produce the discovery sought;
(4)It is frivolous or abusive;
(5)It is cumulative or duplicative;
(6)The material sought is privileged or otherwise protected from disclosure by law;
(7)The material sought relates to mental impressions, conclusions, or legal theories of any party, attorney, or other representative, of a party prepared in anticipation of a proceeding; or
(8)The material sought is available generally to the public, equally to the parties, or to the party seeking the discovery through another source.
(e)*Failure to comply.* Where a party fails to comply with an order of the Administrative Law Judge under this section, the Administrative Law Judge may, among other things, infer that the information would be adverse to the party failing to provide it, exclude the information from evidence or issue a decision by default.
(f)*Other discovery.* No discovery other than that specifically provided for in this section is permitted.
(g)*Effective/applicability date.* This section is applicable to proceedings initiated on or after September 26, 2007. **Par. 30.** Newly designated § 10.72 is amended by: 1. Redesignating paragraphs (b),
(c)and
(d)as paragraphs (d),
(e)and (f), respectively. 2. Revising paragraph
(a)and newly designated paragraph (d). 3. Adding new paragraphs (b),
(c)and (g). The additions and revisions read as follows: § 10.72 Hearings.
(a)*In general* —(1) *Presiding officer.* An Administrative Law Judge will preside at the hearing on a complaint filed under § 10.60 for the sanction of a practitioner, employer, firm or other entity, or appraiser.
(2)*Time for hearing.* Absent a determination by the Administrative Law Judge that, in the interest of justice, a hearing must be held at a later time, the Administrative Law Judge should, on notice sufficient to allow proper preparation, schedule the hearing to occur no later than 180 days after the time for filing the answer.
(3)*Procedural requirements.*
(i)Hearings will be stenographically recorded and transcribed and the testimony of witnesses will be taken under oath or affirmation.
(ii)Hearings will be conducted pursuant to 5 U.S.C. 556.
(iii)A hearing in a proceeding requested under § 10.82(g) will be conducted de novo.
(iv)An evidentiary hearing must be held in all proceedings prior to the issuance of a decision by the Administrative Law Judge unless—
(A)The Director of the Office of Professional Responsibility withdraws the complaint;
(B)A decision is issued by default pursuant to § 10.64(d);
(C)A decision is issued under § 10.82(e);
(D)The respondent requests a decision on the written record without a hearing; or
(E)The Administrative Law Judge issues a decision under § 10.68(d) or rules on another motion that disposes of the case prior to the hearing.
(b)*Cross-examination.* A party is entitled to present his or her case or defense by oral or documentary evidence, to submit rebuttal evidence, and to conduct cross-examination, in the presence of the Administrative Law Judge, as may be required for a full and true disclosure of the facts. This paragraph
(b)does not limit a party from presenting evidence contained within a deposition when the Administrative Law Judge determines that the deposition has been obtained in compliance with the rules of this subpart D.
(c)*Prehearing memorandum.* Unless otherwise ordered by the Administrative Law Judge, each party shall file, and serve on the opposing party or the opposing party's representative, prior to any hearing, a prehearing memorandum containing—
(1)A list (together with a copy) of all proposed exhibits to be used in the party's case in chief;
(2)A list of proposed witnesses, including a synopsis of their expected testimony, or a statement that no witnesses will be called;
(3)Identification of any proposed expert witnesses, including a synopsis of their expected testimony and a copy of any report prepared by the expert or at his or her direction; and
(4)A list of undisputed facts.
(d)*Publicity* —(1) *In general.* All reports and decisions of the Secretary of the Treasury, or delegate, including any reports and decisions of the Administrative Law Judge, under this subpart D are, subject to the protective measures in paragraph (d)(4) of this section, public and open to inspection within 30 days after the agency's decision becomes final.
(2)*Request for additional publicity.* The Administrative Law Judge may grant a request by a practitioner or appraiser that all the pleadings and evidence of the disciplinary proceeding be made available for inspection where the parties stipulate in advance to adopt the protective measures in paragraph (d)(4) of this section.
(3)*Returns and return information* —(i) *Disclosure to practitioner or appraiser.* Pursuant to section 6103(l)(4) of the Internal Revenue Code, the Secretary of the Treasury, or delegate, may disclose returns and return information to any practitioner or appraiser, or to the authorized representative of the practitioner or appraiser, whose rights are or may be affected by an administrative action or proceeding under this subpart D, but solely for use in the action or proceeding and only to the extent that the Secretary of the Treasury, or delegate, determines that the returns or return information are or may be relevant and material to the action or proceeding.
(ii)*Disclosure to officers and employees of the Department of the Treasury.* Pursuant to section 6103(l)(4)(B) of the Internal Revenue Code, the Secretary of the Treasury, or delegate, may disclose returns and return information to officers and employees of the Department of the Treasury for use in any action or proceeding under this subpart D, to the extent necessary to advance or protect the interests of the United States.
(iii)*Use of returns and return information.* Recipients of returns and return information under this paragraph (d)(3) may use the returns or return information solely in the action or proceeding, or in preparation for the action or proceeding, with respect to which the disclosure was made.
(iv)*Procedures for disclosure of returns and return information.* When providing returns or return information to the practitioner or appraiser, or authorized representative, the Secretary of the Treasury, or delegate, will—
(A)Redact identifying information of any third party taxpayers and replace it with a code;
(B)Provide a key to the coded information; and
(C)Notify the practitioner or appraiser, or authorized representative, of the restrictions on the use and disclosure of the returns and return information, the applicable damages remedy under section 7431 of the Internal Revenue Code, and that unauthorized disclosure of information provided by the Internal Revenue Service under this paragraph (d)(3) is also a violation of this part.
(4)*Protective measures* —(i) *Mandatory protective order.* If redaction of names, addresses, and other identifying information of third party taxpayers may still permit indirect identification of any third party taxpayer, the Administrative Law Judge will issue a protective order to ensure that the identifying information is available to the parties and the Administrative Law Judge for purposes of the proceeding, but is not disclosed to, or open to inspection by, the public.
(ii)*Authorized orders.*
(A)Upon motion by a party or any other affected person, and for good cause shown, the Administrative Law Judge may make any order which justice requires to protect any person in the event disclosure of information is prohibited by law, privileged, confidential, or sensitive in some other way, including, but not limited to, one or more of the following— ( *1* ) That disclosure of information be made only on specified terms and conditions, including a designation of the time or place; ( *2* ) That a trade secret or other information not be disclosed, or be disclosed only in a designated way.
(iii)*Denials.* If a motion for a protective order is denied in whole or in part, the Administrative Law Judge may, on such terms or conditions as the Administrative Law Judge deems just, order any party or person to comply with, or respond in accordance with, the procedure involved.
(iv)*Public inspection of documents.* The Secretary of the Treasury, or delegate, shall ensure that all names, addresses or other identifying details of third party taxpayers are redacted and replaced with the code assigned to the corresponding taxpayer in all documents prior to public inspection of such documents.
(g)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 31.** Newly designated § 10.73 is amended by: 1. Redesignating paragraphs (c), (d), and
(e)as paragraphs (d), (e), and (f), respectively. 2. Revising paragraph
(b)and newly designated paragraph (d). 3. Adding new paragraphs
(c)and (g). The revisions and additions read as follows: § 10.73 Evidence.
(b)*Depositions.* The deposition of any witness taken pursuant to § 10.71 may be admitted into evidence in any proceeding instituted under § 10.60.
(c)*Requests for admission.* Any matter admitted in response to a request for admission under § 10.71 is conclusively established unless the Administrative Law Judge on motion permits withdrawal or modification of the admission. Any admission made by a party is for the purposes of the pending action only and is not an admission by a party for any other purpose, nor may it be used against a party in any other proceeding.
(d)*Proof of documents.* Official documents, records, and papers of the Internal Revenue Service and the Office of Professional Responsibility are admissible in evidence without the production of an officer or employee to authenticate them. Any documents, records, and papers may be evidenced by a copy attested to or identified by an officer or employee of the Internal Revenue Service or the Treasury Department, as the case may be.
(g)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 32.** Section 10.76 is revised to read as follows: § 10.76 Decision of Administrative Law Judge.
(a)*In general* —
(1)*Hearings.* Within 180 days after the conclusion of a hearing and the receipt of any proposed findings and conclusions timely submitted by the parties, the Administrative Law Judge should enter a decision in the case. The decision must include a statement of findings and conclusions, as well as the reasons or basis for making such findings and conclusions, and an order of censure, suspension, disbarment, monetary penalty, disqualification, or dismissal of the complaint.
(2)*Summary adjudication.* In the event that a motion for summary adjudication is filed, the Administrative Law Judge should rule on the motion for summary adjudication within 60 days after the party in opposition files a written response, or if no written response is filed, within 90 days after the motion for summary adjudication is filed. A decision shall thereafter be rendered if the pleadings, depositions, admissions, and any other admissible evidence show that there is no genuine issue of material fact and that a decision may be rendered as a matter of law. The decision must include a statement of conclusions, as well as the reasons or basis for making such conclusions, and an order of censure, suspension, disbarment, monetary penalty, disqualification, or dismissal of the complaint.
(3)*Returns and return information.* In the decision, the Administrative Law Judge should use the code assigned to third party taxpayers (described in § 10.72(d)).
(b)*Standard of proof.* If the sanction is censure or a suspension of less than six months' duration, the Administrative Law Judge, in rendering findings and conclusions, will consider an allegation of fact to be proven if it is established by the party who is alleging the fact by a preponderance of the evidence in the record. If the sanction is a monetary penalty, disbarment or a suspension of six months or longer duration, an allegation of fact that is necessary for a finding against the practitioner must be proven by clear and convincing evidence in the record. An allegation of fact that is necessary for a finding of disqualification against an appraiser must be proven by clear and convincing evidence in the record.
(c)*Copy of decision.* The Administrative Law Judge will provide the decision to the Director of the Office of Professional Responsibility, with a copy to the Director's authorized representative, and a copy of the decision to the respondent or the respondent's authorized representative.
(d)*When final.* In the absence of an appeal to the Secretary of the Treasury or delegate, the decision of the Administrative Law Judge will, without further proceedings, become the decision of the agency 30 days after the date of the Administrative Law Judge's decision.
(e)*Effective/applicability date.* This section is applicable to proceedings initiated on or after September 26, 2007. **Par. 33.** Section 10.77 is revised to read as follows: § 10.77 Appeal of decision of Administrative Law Judge.
(a)*Appeal.* Any party to the proceeding under this subpart D may file an appeal of the decision of the Administrative Law Judge with the Secretary of the Treasury, or delegate. The appeal must include a brief that states exceptions to the decision of the Administrative Law Judge and supporting reasons for such exceptions.
(b)*Time and place for filing of appeal.* The appeal and brief must be filed, in duplicate, with the Director of the Office of Professional Responsibility within 30 days of the date that the decision of the Administrative Law Judge is served on the parties. The Director of the Office of Professional Responsibility will immediately furnish a copy of the appeal to the Secretary of the Treasury or delegate who decides appeals. A copy of the appeal for review must be sent to any non-appealing party. If the Director of the Office of Professional Responsibility files an appeal, he or she will provide a copy of the appeal and certify to the respondent that the appeal has been filed.
(c)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 34.** Section 10.78 is revised to read as follows: § 10.78 Decision on review.
(a)*Decision on review.* On appeal from or review of the decision of the Administrative Law Judge, the Secretary of the Treasury, or delegate, will make the agency decision. The Secretary of the Treasury, or delegate, should make the agency decision within 180 days after receipt of the appeal.
(b)*Standard of review.* The decision of the Administrative Law Judge will not be reversed unless the appellant establishes that the decision is clearly erroneous in light of the evidence in the record and applicable law. Issues that are exclusively matters of law will be reviewed de novo. In the event that the Secretary of the Treasury, or delegate, determines that there are unresolved issues raised by the record, the case may be remanded to the Administrative Law Judge to elicit additional testimony or evidence.
(c)*Copy of decision on review.* The Secretary of the Treasury, or delegate, will provide copies of the agency decision to the Director of the Office of Professional Responsibility and the respondent or the respondent's authorized representative.
(d)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 35.** Section 10.82 is amended by: 1. Revising the section heading and paragraph (b). 2. Adding paragraph (h). The revisions and addition read as follows: § 10.82 Expedited suspension.
(b)*To whom applicable.* This section applies to any practitioner who, within five years of the date a complaint instituting a proceeding under this section is served:
(1)Has had a license to practice as an attorney, certified public accountant, or actuary suspended or revoked for cause (not including failure to pay a professional licensing fee) by any authority or court, agency, body, or board described in § 10.51(a)(10).
(2)Has, irrespective of whether an appeal has been taken, been convicted of any crime under title 26 of the United States Code, any crime involving dishonesty or breach of trust, or any felony for which the conduct involved renders the practitioner unfit to practice before the Internal Revenue Service.
(3)Has violated conditions imposed on the practitioner pursuant to § 10.79(d).
(4)Has been sanctioned by a court of competent jurisdiction, whether in a civil or criminal proceeding (including suits for injunctive relief), relating to any taxpayer's tax liability or relating to the practitioner's own tax liability, for—
(i)Instituting or maintaining proceedings primarily for delay;
(ii)Advancing frivolous or groundless arguments; or
(iii)Failing to pursue available administrative remedies.
(h)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 36.** Section 10.90 is revised to read as follows: § 10.90 Records.
(a)*Roster.* The Director of the Office of Professional Responsibility will maintain, and may make available for public inspection in the time and manner prescribed by the Secretary of the Treasury, or delegate, rosters of—
(1)Enrolled agents, including individuals—
(i)Granted active enrollment to practice;
(ii)Whose enrollment has been placed in inactive status for failure to meet the requirements for renewal of enrollment;
(iii)Whose enrollment has been placed in inactive retirement status; and
(iv)Whose offer of consent to resign from enrollment has been accepted by the Director of the Office of Professional Responsibility under § 10.61;
(2)Individuals (and employers, firms or other entities, if applicable) censured, suspended, or disbarred from practice before the Internal Revenue Service or upon whom a monetary penalty was imposed;
(3)Disqualified appraisers; and
(4)Enrolled retirement plan agents, including individuals—
(i)Granted active enrollment to practice;
(ii)Whose enrollment has been placed in inactive status for failure to meet the requirements for renewal of enrollment;
(iii)Whose enrollment has been placed in inactive retirement status; and
(iv)Whose offer of consent to resign from enrollment has been accepted by the Director of the Office of Professional Responsibility under § 10.61.
(b)*Other records.* Other records of the Director of the Office of Professional Responsibility may be disclosed upon specific request, in accordance with the applicable law.
(b)*Effective/applicability date.* This section is applicable on September 26, 2007. **Par. 36.** Section 10.91 is revised to read as follows: § 10.91 Saving provision. Any proceeding instituted under this part prior to July 26, 2002, for which a final decision has not been reached or for which judicial review is still available will not be affected by these revisions. Any proceeding under this part based on conduct engaged in prior to September 26, 2007, which is instituted after that date, will apply subpart D and E or this part as revised, but the conduct engaged in prior to the effective date of these revisions will be judged by the regulations in effect at the time the conduct occurred. Linda E. Stiff, Acting Deputy Commissioner for Services and Enforcement. Approved: September 19, 2007. Robert Hoyt, General Counsel, Office of the Secretary. [FR Doc. E7-18918 Filed 9-25-07; 8:45 am] BILLING CODE 4830-01-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2007-0886; FRL-8473-3] Approval and Promulgation of Implementation Plans; Arkansas; Clean Air Interstate Rule Nitrogen Oxides Ozone Season Trading Program AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: EPA is taking a direct final action to approve a revision to the Arkansas State Implementation Plan
(SIP)submitted on August 10, 2007, enacted at Regulation 19—Arkansas Plan of Implementation for Air Pollution Control; Chapter 14, Sections 19.1401-19.1404; and Chapter 15, Section 19.1501. This revision addresses the requirements of EPA's Clean Air Interstate Rule
(CAIR)Nitrogen Oxides (NO <sup>X</sup> ) Ozone Season Trading Program, promulgated on May 12, 2005 and subsequently revised on April 28 and December 13, 2006. EPA is approving the SIP revision as fully implementing the CAIR NO <sup>X</sup> ozone season requirements for Arkansas. Therefore, as a consequence of this SIP approval, EPA will also withdraw the CAIR Federal Implementation Plan (CAIR FIP) concerning NO <sup>X</sup> ozone season emissions for Arkansas. The CAIR FIPs for all States in the CAIR region were promulgated on April 28, 2006 and subsequently revised on December 13, 2006. The intended effect of this action is to reduce NO <sup>X</sup> emissions from the State of Arkansas that are contributing to nonattainment of the 8-hour ozone National Ambient Air Quality Standard (NAAQS or standard) in downwind states. This action is being taken under section 110 of the Federal Clean Air Act (the Act or CAA). DATES: This rule is effective on November 26, 2007 without further notice, unless EPA receives relevant adverse comment by October 26, 2007. If EPA receives such comment, EPA will publish a timely withdrawal in the **Federal Register** informing the public that this rule will not take effect. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R06-OAR-2007-0886, by one of the following methods:
(1)*www.regulations.gov:* Follow the on-line instructions for submitting comments.
(2)*E-mail:* Mr. Jeff Robinson at *robinson.jeffrey@epa.gov.* Please also cc the person listed in the FOR FURTHER INFORMATION CONTACT paragraph below.
(3)*U.S. EPA Region 6 “Contact Us” Web site:* *http://www.epa.gov/region6/r6coment.htm.* Please click on “6PD” (Multimedia) and select “Air” before submitting comments.
(4)*Fax:* Mr. Jeff Robinson, Chief, Air Permits Section (6PD-R), at fax number 214-665-6762.
(5)*Mail:* Mr. Jeff Robinson, Chief, Air Permits Section (6PD-R), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202-2733.
(6)*Hand or Courier Delivery:* Mr. Jeff Robinson, Chief, Air Permits Section (6PD-R), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202-2733. Such deliveries are accepted only between the hours of 8:30 a.m. and 4:30 p.m. weekdays except for legal holidays. Special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID No. EPA-R06-OAR-2007-0886. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.regulations.gov,* including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information the disclosure of which is restricted by statute. Do not submit information through *http://www.regulations.gov* or e-mail, if you believe that it is CBI or otherwise protected from disclosure. The *http://www.regulations.gov* Web site is an “anonymous access” system, which means that EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *http://www.regulations.gov,* your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment along with any disk or CD-ROM submitted. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters and any form of encryption and should be free of any defects or viruses. For additional information about EPA's public docket, visit the EPA Docket Center homepage at *http://www.epa.gov/epahome/dockets.htm.* *Docket:* All documents in the docket are listed in the *http://www.regulations.gov* index. Although listed in the index, some information is not publicly available, *e.g.* , CBI or other information the disclosure of which is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *http://www.regulations.gov* or in hard copy at the Air Permits Section (6PD-R), Environmental Protection Agency, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733. The file will be made available by appointment for public inspection in the Region 6 FOIA Review Room between the hours of 8:30 a.m. and 4:30 p.m. weekdays except for legal holidays. Contact the person listed in the FOR FURTHER INFORMATION CONTACT section of this **Federal Register** to make an appointment. If possible, please make the appointment at least two working days in advance of your visit. A 15 cent per page fee will be charged for making photocopies of documents. On the day of the visit, please check in at the EPA Region 6 reception area on the seventh floor at 1445 Ross Avenue, Suite 700, Dallas, Texas. The State submittal related to this SIP revision, and which is part of the EPA docket, is also available for public inspection at the State Air Agency listed below during official business hours by appointment: Arkansas Department of Environmental Quality, Air Division, 8001 National Drive, P.O. Box 8913, Little Rock, Arkansas 72219-8913. FOR FURTHER INFORMATION CONTACT: If you have questions concerning today's action, please contact Ms. Adina Wiley, Air Permits Section (6PD-R), Environmental Protection Agency, Region 6, 1445 Ross Avenue, Suite 1200, Dallas, TX 75202-2733. The telephone number is
(214)665-2115. Ms. Wiley can also be reached via electronic mail at *wiley.adina@epa.gov.* SUPPLEMENTARY INFORMATION: Throughout this document wherever any reference to “we,” “us,” or “our” is used, we mean EPA. Table of Contents I. What Action Is EPA Taking? II. What Is the Regulatory History of CAIR and the CAIR FIPs? III. What Are the General Requirements of CAIR and the CAIR FIPs? IV. What Are the Types of CAIR SIP Submittals? V. What Is EPA's Analysis of the Arkansas CAIR NO <sup>X</sup> Ozone Season SIP Submittal A. State Budget for NO <sup>X</sup> Ozone Season Allowance Allocations B. CAIR NO <sup>X</sup> Ozone Season Cap-and-Trade Program C. Applicability Provisions for Non-EGU NO <sup>X</sup> SIP Call Sources D. NO <sup>X</sup> Ozone Season Allowance Allocations E. Individual Opt-In Units VI. Final Action VII. Statutory and Executive Order Reviews I. What Action Is EPA Taking? EPA is taking direct final action to approve a revision to Arkansas's SIP, submitted on August 10, 2007, enacted at Regulation 19—Arkansas Plan of Implementation for Air Pollution Control; Chapter 14, Sections 19.1401-19.1404; and Chapter 15, Section 19.1501. In its SIP revision, Arkansas would meet CAIR NO <sup>X</sup> ozone season requirements by requiring certain electric generating units
(EGUs)to participate in the EPA-administered CAIR cap-and-trade program addressing NO <sup>X</sup> ozone season emissions. The SIP as revised that EPA is approving meets the applicable requirements of CAIR. Our detailed analysis of this SIP revision is in the Technical Support Document
(TSD)for the Arkansas CAIR NO <sup>X</sup> Ozone Season Trading Program. The TSD is available as specified in the section of this document identified as ADDRESSES . As a consequence of the SIP approval, the Administrator of EPA will also issue a final rule to withdraw the FIP concerning NO <sup>X</sup> ozone season emissions for Arkansas. This action will delete and reserve 40 CFR 52.184 in part 52. The withdrawal of the CAIR FIP for Arkansas is a conforming amendment that must be made once the SIP is approved because EPA's authority to issue the FIP was premised on a deficiency in the SIP for Arkansas. Once the SIP is fully approved, EPA no longer has authority for the FIP since the deficiency has been corrected. Thus, EPA will not have the option of maintaining the FIP following the full SIP approval. Accordingly, EPA does not intend to offer an opportunity for a public hearing or an additional opportunity for written public comment on the withdrawal of the FIP. We are publishing this rule without prior proposal because we view this as a noncontroversial amendment and anticipate no relevant adverse comments. However, in the proposed rules section of this **Federal Register** publication, we are publishing a separate document that will serve as the proposal to approve the SIP revision if relevant adverse comments are received. This rule will be effective on November 26, 2007 without further notice unless we receive relevant adverse comment by October 26, 2007. If we receive relevant adverse comments, we will publish a timely withdrawal in the **Federal Register** informing the public that the rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so now. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment. II. What Is the Regulatory History of CAIR and the CAIR FIPs? The Clean Air Interstate Rule
(CAIR)was published by EPA on May 12, 2005 (70 FR 25162). In this rule, EPA determined that 28 States and the District of Columbia contribute significantly to nonattainment and interfere with maintenance of the national ambient air quality standards (NAAQS) for fine particles (PM <sup>2.5</sup> ) and /or 8-hour ozone in downwind States in the eastern part of the country. As a result, EPA required those upwind States to revise their SIPs to include control measures that reduce emissions of SO <sup>2</sup> , which is a precursor to PM <sup>2.5</sup> formation, and/or NO <sup>X</sup> , which is a precursor to both ozone and PM <sup>2.5</sup> formation. For jurisdictions that contribute significantly to downwind PM <sup>2.5</sup> nonattainment, CAIR sets annual State-wide emission reduction requirements (i.e., budgets) for SO <sup>2</sup> and annual State-wide emission reduction requirements for NO <sup>X</sup> . Similarly, for jurisdictions that contribute significantly to 8-hour ozone nonattainment, CAIR sets State-wide emission reduction requirements for NO <sup>X</sup> for the ozone season (defined at 40 CFR 97.302 as May 1st to September 30th). Under CAIR, States may implement these reduction requirements by participating in the EPA-administered cap-and-trade programs or by adopting any other control measures. Arkansas was found to significantly contribute to nonattainment of the 8-hour ozone standard in Texas, resulting in Arkansas being subject to the NO <sup>X</sup> ozone season CAIR requirements. CAIR explains to subject States what must be included in SIPs to address the requirements of section 110(a)(2)(D) of the Clean Air Act
(CAA)with regard to interstate transport with respect to the 8-hour ozone and PM <sup>2.5</sup> NAAQS. EPA made national findings, effective on May 25, 2005, that the States had failed to submit SIPs meeting the requirements of section 110(a)(2)(D). The SIPs were due in July 2000, 3 years after the promulgation of the 8-hour ozone and PM <sup>2.5</sup> NAAQS. These findings started a 2-year clock for EPA to promulgate a Federal Implementation Plan
(FIP)to address the requirements of section 110(a)(2)(D). Under CAA section 110(c)(1), EPA may issue a FIP anytime after such findings are made and must do so within two years unless a SIP revision correcting the deficiency is approved by EPA before the FIP is promulgated. On April 28, 2006, EPA promulgated CAIR FIPs for all States covered by CAIR in order to ensure the emissions reductions required by CAIR are achieved on schedule (71 FR 25328). See 40 CFR 52.35 and 52.36. Each CAIR State is subject to the FIP until the State fully adopts, and EPA approves, a SIP revision meeting the requirements of CAIR. The CAIR FIPs require certain EGUs to participate in the EPA-administered CAIR SO <sup>2</sup> , NO <sup>X</sup> annual, and NO <sup>X</sup> ozone season trading programs, as appropriate, found at 40 CFR part 97. The CAIR FIP SO <sup>2</sup> , NO <sup>X</sup> annual, and NO <sup>X</sup> ozone season trading programs impose essentially the same requirements as, and are integrated with, the respective CAIR SIP trading programs. The integration of the CAIR FIP and SIP trading programs means that these trading programs will work together to create effectively a single trading program for each regulated pollutant (SO <sup>2</sup> , NO <sup>X</sup> annual, and NO <sup>X</sup> ozone season) in all States covered by the CAIR FIP or SIP trading program for that pollutant. The CAIR FIPs also allow States to submit abbreviated SIP revisions that, if approved by EPA, will automatically replace or supplement certain CAIR FIP provisions, while the CAIR FIPs remain in place for all other provisions. On April 28, 2006, EPA published two additional CAIR-related final rules that added the States of Delaware and New Jersey to the list of States subject to CAIR for PM <sup>2.5</sup> and announced EPA's final decisions on reconsideration of five issues, without making any substantive changes to the CAIR requirements (71 FR 25288 and 71 FR 25304, respectively). On December 13, 2006, EPA published minor, non-substantive revisions that serve to clarify the CAIR and CAIR FIP regulations (71 FR 74792). III. What Are the General Requirements of CAIR and the CAIR FIPs? CAIR establishes State-wide emission budgets for SO <sup>2</sup> and NO <sup>X</sup> and is to be implemented in two phases. The first phase of NO <sup>X</sup> reductions starts in 2009 and continues through 2014, while the first phase of SO <sup>2</sup> reductions starts in 2010 and continues through 2014. The second phase of reductions for both NO <sup>X</sup> and SO <sup>2</sup> starts in 2015 and continues thereafter. CAIR requires States to implement the budgets by either:
(1)Requiring EGUs to participate in the EPA-administered cap-and-trade programs; or
(2)adopting other control measures of the State's choosing and demonstrating that such control measures will result in compliance with the applicable State SO <sup>2</sup> and NO <sup>X</sup> budgets. The May 12, 2005 and April 28, 2006 CAIR rules provide model rules that States must adopt (with certain limited changes, if desired) if they want to participate in the EPA-administered trading programs. The December 13, 2006, revisions to the CAIR and CAIR FIP regulations were non-substantive and, therefore, do not affect EPA's evaluation of a State's SIP revision. With two exceptions, only States that choose to meet the requirements of CAIR through methods that exclusively regulate EGUs are allowed to participate in the EPA-administered trading programs. One exception is for States that adopt the opt-in provisions of the model rules to allow non-EGUs individually to opt into the EPA-administered trading programs. The other exception is for States that include all non-EGUs from their NO <sup>X</sup> SIP Call trading programs in their CAIR NO <sup>X</sup> ozone season trading programs. Arkansas was not subject to the NO <sup>X</sup> SIP Call requirements; therefore this exception is not available to the State. IV. What Are the Types of CAIR SIP Submittals? States have the flexibility to choose the type of control measures they will use to meet the requirements of CAIR. EPA anticipates that most States will choose to meet the CAIR requirements by selecting an option that requires EGUs to participate in the EPA-administered CAIR cap-and-trade programs. For such States, EPA has provided two approaches for submitting and obtaining approval for CAIR SIP revisions. States may submit full SIP revisions that adopt the model CAIR cap-and-trade rules. If approved, these SIP revisions will fully replace the State's CAIR FIPs. Alternatively, States may submit abbreviated SIP revisions. The provisions in the abbreviated SIP revision, if approved into a State's SIP, will not replace that State's CAIR FIP; however, the requirements for the CAIR FIPs at 40 CFR part 52 incorporate the provisions of the Federal CAIR trading programs in 40 CFR part 97. The Federal CAIR trading programs in 40 CFR part 97 provide that whenever EPA approves an abbreviated SIP revision, the provisions in the abbreviated SIP revision will be used in place of or in conjunction with, as appropriate, the corresponding provisions in 40 CFR part 97 of the State's CAIR FIP. A State submitting a full SIP revision may either adopt regulations that are substantively identical to the model rules or incorporate by reference the model rules. CAIR provides that States may only make limited changes to the model rules if the States want to participate in the EPA-administered trading programs. A full SIP revision may change the model rules only by altering their applicability and allowance allocation provisions to:
(1)Include NO <sup>X</sup> SIP Call trading sources that are not EGUs under CAIR in the CAIR NO <sup>X</sup> Ozone Season Trading Program;
(2)Provide for State allocation of NO <sup>X</sup> annual or ozone season allowances using a methodology chosen by the State;
(3)Provide for State allocation of NO <sup>X</sup> annual allowances from the compliance supplement pool
(CSP)using the State's choice of allowed, alternative methodologies; or
(4)Allow units that are not otherwise CAIR units to opt individually into the CAIR SO <sup>2</sup> , NO <sup>X</sup> Annual, or NO <sup>X</sup> Ozone Season Trading Programs under the opt-in provisions in the model rules. EPA's authority to issue the CAIR FIPs was premised on the deficiency of each State's SIP in addressing the CAIR requirements. EPA will not have the option of maintaining the CAIR FIP following approval of a full CAIR SIP revision. Therefore, an approved CAIR full SIP revision will replace the CAIR FIP requirements for NO <sup>X</sup> annual, NO <sup>X</sup> ozone season, or SO <sup>2</sup> emissions, as applicable, for that State. V. What Is EPA's Analysis of the Arkansas CAIR NO <sup>X</sup> Ozone Season SIP Submittal? A. State Budget for NO X Ozone Season Allowance Allocations The CAIR NO <sup>X</sup> ozone season budgets for Arkansas were developed from historical heat input data for EGUs. Using these data, EPA calculated annual and ozone season regional heat input values, which were multiplied by 0.15 lb/mmBtu, for phase 1, and 0.125 lb/mmBtu, for phase 2, to obtain regional NO <sup>X</sup> budgets for 2009-2014 and for 2015 and thereafter, respectively. EPA derived the Arkansas NO <sup>X</sup> ozone season budgets from the regional budgets using Arkansas heat input data adjusted by fuel factors. The CAIR SIP requirements and the Arkansas CAIR NO <sup>X</sup> ozone season FIP establish the NO <sup>X</sup> ozone season budgets for Arkansas as 11,515 tons of NO <sup>X</sup> ozone season emissions for 2009-2014 and 9,596 tons of NO <sup>X</sup> ozone season emissions in 2015 and thereafter. Arkansas's rules at 19.1402 establish that the total amount of NO <sup>X</sup> ozone season allowances allocated per control period is as listed in 40 CFR 51.123 and 96.340; ensuring that the Arkansas allocation methodology will not allocate more allowances than the state NO <sup>X</sup> ozone season budget, consistent with 40 CFR 51.123. B. CAIR NO X Ozone Season Cap-and-Trade Program The CAIR NO <sup>X</sup> annual and ozone season FIPs for the States largely mirror the structure of the NO <sup>X</sup> SIP Call model-trading rule in 40 CFR part 96 subparts A through I. While the provisions of the NO <sup>X</sup> annual and ozone season FIPs are similar, there are some differences. For example, the NO <sup>X</sup> Annual FIPs provide for a compliance supplement pool, under which allowances may be awarded for early reductions of NO <sup>X</sup> annual emissions. EPA used the CAIR model trading rules as the basis for the SO <sup>2</sup> , NO <sup>X</sup> annual, and NO <sup>X</sup> ozone season trading programs incorporated by reference into the States' CAIR FIPs. The CAIR FIP trading programs' rules are virtually identical to the CAIR model trading rules, with changes made to account for federal rather than state implementation. The CAIR model SO <sup>2</sup> , NO <sup>X</sup> annual, and NO <sup>X</sup> ozone season trading rules and the respective CAIR FIP trading programs are designed to work together as integrated SO <sup>2</sup> , NO <sup>X</sup> annual, and NO <sup>X</sup> ozone season trading programs. In the August 10, 2007, SIP revision, Arkansas chose to implement its CAIR NO <sup>X</sup> ozone season budgets by requiring EGUs to participate in the EPA-administered cap-and-trade program for NO <sup>X</sup> ozone season emissions. Arkansas has adopted a full SIP revision that incorporates by reference the CAIR model cap-and-trade rule for NO <sup>X</sup> ozone season emissions as published at 40 CFR part 96, subparts AAAA-HHHH on May 12, 2005, and further revised on April 28 and December 13, 2006. This SIP revision does not include subpart IIII, CAIR NO <sup>X</sup> Ozone Season Opt-in Units, and any references to opt-in units. This SIP revision provides an allowance allocation methodology that replaces 40 CFR part 96, subpart EEEE. C. Applicability Provisions for Non-EGU NO X SIP Call Sources In general, the CAIR FIPs' trading programs apply to any stationary, fossil-fuel-fired boiler or stationary, fossil-fuel-fired combustion turbine serving at any time, since the later of November 15, 1990 or the start-up of the unit's combustion chamber, a generator with nameplate capacity of more than 25 MWe producing electricity for sale. Because Arkansas was not included in the NO <sup>X</sup> SIP Call trading program, Arkansas does not have or need the option of expanding the applicability provisions of the CAIR NO <sup>X</sup> Ozone Season Trading Program to include non-EGU NO <sup>X</sup> SIP Call sources. D. NO X Ozone Season Allowance Allocations Under the NO <sup>X</sup> allowance allocation methodology in the CAIR model trading rules and in the CAIR FIP NO <sup>X</sup> ozone season trading programs, NO <sup>X</sup> ozone season allowances are allocated to units that have operated for five years, based on heat input data from a three-year period that are adjusted for fuel type by using fuel factors of 1.0 for coal, 0.6 for oil, and 0.4 for other fuels. The CAIR model trading rules and the CAIR FIP NO <sup>X</sup> ozone season trading program also provide a new unit set-aside from which units without five years of operation are allocated allowances based on the units' prior year emissions. The CAIR FIP provisions provide States with the flexibility to establish a different NO <sup>X</sup> allowance allocation methodology that will be used to allocate allowances to sources in a State if certain requirements are met concerning the timing of submission of units' allocations to the Administrator for recordation and the total amount of allowances allocated for each control period. In adopting alternative NO <sup>X</sup> allowance allocation methodologies, States have flexibility with regard to:
(1)The cost to recipients of the allowances, which may be distributed for free or auctioned;
(2)The frequency of allocations;
(3)The basis for allocating allowances, which may be distributed, for example, based on historical heat input or electric and thermal output; and
(4)The use of allowance set-asides and, if used, their size. Consistent with the flexibility given to States in their CAIR FIP provisions, Arkansas has chosen to replace the provisions of the Arkansas CAIR NO <sup>X</sup> Ozone Season FIP concerning the allocation of NO <sup>X</sup> ozone season allowances with its own methodology. To address the concerns of interstate transport, the ADEQ initiated a stakeholder process to work with affected industry and EPA Region 6. As a result of the stakeholder process, ADEQ submitted a full CAIR NO <sup>X</sup> Ozone Season SIP revision on August 10, 2007. Section 19.1401 incorporates by reference 40 CFR part 96, subparts AAAA-HHHH, with the exception of EEEE, as promulgated by EPA on May 12, 2005, and further revised on April 28 and December 13, 2006. Additionally, section 19.1401 states that Subpart IIII and all references to opt-in units are not incorporated into the Arkansas SIP. Sections 19.1402-19.1404 of the Arkansas CAIR NO <sup>X</sup> Ozone Season Trading Program SIP revision establish the NO <sup>X</sup> ozone season allowance allocation methodology that is to be used in place of 40 CFR part 96, subpart EEEE. Section 19.1402 establishes that the Arkansas NO <sup>X</sup> Ozone Season budget is 11,515 tons per control period from 2009-2014 and 9,596 tons per control period starting with the 2015 control period. These budgets are as listed in 40 CFR 51.123(q)(2) (11,515 tons in 2009-2014 and 9,596 tons in 2015 and thereafter); ensuring that the Arkansas allocation methodology will not allocate more allowances than the state NO <sup>X</sup> ozone season budget. Section 19.1403 establishes the dates by which the ADEQ must submit NO <sup>X</sup> ozone season allocations to EPA for recordation in CAIR compliance accounts. Section 19.1403 is divided further based on unit operating history; 19.1403(A) provides the allowance allocation timing for the EGUs with a baseline gross electric generation as defined in 19.1404(A), and 19.1403(B) provides the allowance allocation timing for the EGUs without a baseline gross electric generation. No later than April 30, 2007, the ADEQ will determine and submit to the EPA the CAIR NO <sup>X</sup> ozone season allowances for the control periods 2009, 2010, and 2011, for EGUs with a baseline gross electric generation. Additionally for the EGUs with a baseline gross electric generation, the ADEQ will determine and submit to the EPA the CAIR NO <sup>X</sup> ozone season allowances by October 31, 2008, for the year 2012, and by October 31 of each year thereafter for the 4th year after the notification deadline. For EGUs without a baseline gross electric generation, the ADEQ will determine and submit to EPA the NO <sup>X</sup> ozone season allowance allocations by July 31 of the year for which the allowances are allocated. Baseline gross electric generation is determined in accordance with section 19.1404(A) for CAIR units that have operated each calendar year during a period of five or more calendar years. The baseline gross electric generation is the average of the three highest amounts of a CAIR unit's control period gross electrical output over the five years immediately preceding the year in which allocations are due to EPA. If a generator is served by two or more units, the gross electrical output of the generator will be apportioned to each unit based on the unit's share of the total control period heat input for that year. The ADEQ submitted a letter to the EPA dated June 7, 2007, to further explain section 19.1404(A). Once a unit has operated for five or more calendar years before the allocation submittal deadline and had a calculable baseline gross electric generation, the unit cannot be considered a non-baseline unit in the future. For example, if a unit operated from 2000-2006, the unit would have a calculable baseline gross electric generation used for the 2007, 2008, and 2009 control period allocations. If the unit shutdown or suspended operations for 2007 and started operating again in 2008, the unit would still be considered a baseline unit. The year 2007 would have zero electric output recorded in the baseline calculation. Section 19.1404(C) establishes the allocation methodology for CAIR units with a baseline gross electric generation as calculated pursuant to section 19.1404(A). For each control period, the ADEQ will allocate to all units with a calculable baseline a total amount of allowances equal to 95% of the total ozone season budget established in 19.1402. These units will receive allowances proportional to their share of the total baseline gross electric generation for all such units; i.e., the ratio of the unit's baseline gross electric generation to the total baseline gross electric generation multiplied by the total amount of allowances allocated each control period to units with baseline data. Section 19.1404(D) establishes the allocation methodology for CAIR units without a calculable baseline. For these units, the ADEQ will establish a new unit set-aside for each control period equal to 5% of the total ozone season budget in section 19.1402. Starting with the later of the 2009 control period or the first control period after the control period in which the CAIR unit commences commercial operation, the Designated Representative for the non-baseline units may submit a request to the ADEQ for the set-aside allowances. This request must be submitted to the ADEQ no later than January 1st of the first control period in which the new unit set-aside allowances are requested and after the date in which the new unit commences commercial operation. The request for allowances may not exceed the unit's total tons of NO <sup>X</sup> emissions during the previous control period. On or after February 1st of each control period, the ADEQ will determine the total amount of new unit set-aside allowances requested. If the total amount of allowances requested is less than the total new unit set-aside pool (5% of the overall state budget) the ADEQ will allocate the new unit set-aside allowances as requested to each unit. If the total amount of requested allowances is greater than the total new unit set-aside pool, the ADEQ will determine the allocations by multiplying the ratio of each unit's requested number of allowances to the total amount of requested allowances by the new unit set-aside amount. The ADEQ will then notify each unit's Designated Representative of the amount of new unit set-aside allowances the unit will receive. If there are allowances remaining in the new unit set-aside after the non-baseline units receive their allocations, the ADEQ will allocate these remaining allowances to units with baseline gross electric generation. The ADEQ will multiply the remaining number of allowances by the ratio of the baseline unit's allocation for that control period to the total amount of allowances allocated to the baseline units (95% of the overall state budget in section 19.1402). Section 19.1501 establishes the effective date of the revision to Regulation 19, Chapter 14, Sections 19.1401-19.1404 as ten days after filing with the Arkansas Secretary of State, the Arkansas State Library, and the Arkansas Bureau of Legislative Research. E. Individual Opt-In Units The opt-in provisions of the CAIR model trading rules allow certain non-EGUs (i.e., boilers, combustion turbines, and other stationary fossil-fuel-fired devices) that do not meet the applicability criteria for a CAIR trading program to participate voluntarily in (i.e., opt into) the CAIR trading program. A non-EGU may opt into one or more of the CAIR trading programs. In order to qualify to opt into a CAIR trading program, a unit must vent all emissions through a stack and be able to meet monitoring, recordkeeping, and reporting requirements of 40 CFR part 75. The owners and operators seeking to opt a unit into a CAIR trading program must apply for a CAIR opt-in permit. If the unit is issued a CAIR opt-in permit, the unit becomes a CAIR unit, is allocated allowances, and must meet the same allowance-holding and emissions monitoring and reporting requirements as other units subject to that CAIR trading program. The opt-in provisions provide for two methodologies for allocating allowances for opt-in units, one methodology that applies to opt-in units in general and a second methodology that allocates allowances only to opt-in units that the owners and operators intend to repower before January 1, 2015. States have several options concerning the opt-in provisions. States may adopt the CAIR opt-in provisions entirely or may adopt them but exclude one of the methodologies for allocating allowances. States may also decline to adopt the opt-in provisions. Arkansas has chosen not to allow non-EGUs to opt into the CAIR NO <sup>X</sup> Ozone Season Trading Program. Arkansas incorporated by reference the CAIR NO <sup>X</sup> Ozone Season Trading Program, published at 40 CFR part 96, subparts AAAA-HHHH on May 12, 2005, and further revised on April 28 and December 13, 2006. This SIP revision does not include subpart IIII, CAIR NO <sup>X</sup> Ozone Season Opt-in Units, and any references to opt-in units. VI. Final Action We are approving Arkansas's CAIR NO <sup>X</sup> Ozone Season Trading Program SIP revision submitted on August 10, 2007, enacted at Regulation 19—Arkansas Plan of Implementation for Air Pollution Control; Chapter 14, Sections 19.1401-19.1404; and Chapter 15, Section 19.1501. Under this SIP revision, Arkansas is choosing to participate in the EPA-administered cap-and-trade program for NO <sup>X</sup> ozone season emissions. Our technical analysis has shown that this SIP revision is consistent with the requirements of 40 CFR Part 51, including the specific CAIR NO <sup>X</sup> ozone season requirements at 40 CFR 51.123 as published on May 12, 2005, and further revised on April 28 and December 13, 2006; and all applicable requirements of the CAA. As a consequence of this SIP approval, the Administrator of EPA will also issue, without providing an opportunity for a public hearing or an additional opportunity for written public comment, a final rule to withdraw the CAIR FIP concerning NO <sup>X</sup> ozone season emissions for Arkansas. This action will delete and reserve 40 CFR 52.184 in part 52. VII. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason and because this action will not have a significant, adverse effect on the supply, distribution, or use of energy, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Act. The EPA interprets Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), as applying only to those regulatory actions that concern health or safety risks such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This rule is not subject to Executive Order 13045 because it approves a state rule implementing a Federal standard. Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal executive policy on environmental justice. Because this rule merely approves a state rule implementing a Federal standard, EPA lacks the discretionary authority to modify today's regulatory decision on the basis of environmental justice considerations. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the **Federal Register** . 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 26, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule 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).) List of Subjects 40 CFR Part 52 Environmental protection, Air pollution control, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides. Dated: September 18, 2007. Richard E. Greene, Regional Administrator, EPA Region 6. 40 CFR part 52 is amended as follows: PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* Subpart E—Arkansas 2. Section 52.170 is amended as follows: a. In paragraph
(c)the table entitled “EPA-Approved Regulations in the Arkansas SIP” is amended under Regulation No. 19—Regulations of the Arkansas Plan of Implementation for Air Pollution Control, by removing the existing entries for “Chapter 14—Effective Date” and “Reg. 19.1401” and adding in its place new entries for “Chapter 14—CAIR NO <sup>X</sup> Ozone Season Trading Program General Provisions” and new sub-entries for “Reg. 19.1401”, “Reg. 19.1402”, “Reg. 19.1403”, and “Reg. 19.1404”. b. In paragraph
(c)the table entitled “EPA-Approved Regulations in the Arkansas SIP” is amended under Regulation No. 19—Regulations of the Arkansas Plan of Implementation for Air Pollution Control, by adding in numerical order a new entry for “Chapter 15—Effective Date” and a new sub-entry for “Reg. 19.1501”. § 52.170 Identification of plan.
(c)* * * EPA-Approved Regulations in the Arkansas SIP State citation Title/subject State submittal/ effective date EPA approval date Explanation Regulation No. 19: Regulations the Arkansas Plan of Implementation for Air Pollution Control * * * * * * * Chapter 14—CAIR NO X Ozone Season Trading Program General Provisions * * * * * * * Reg. 19.1401 Adoption of Regulations 07/15/2007 09/26/2007 [Insert *FR* page number where document begins] Reg. 19.1402 State Trading Budget 07/15/2007 09/26/2007 [Insert *FR* page number where document begins] Reg. 19.1403 Timing Requirements for CAIR NO <sup>X</sup> Ozone Season Allowance Allocations 07/15/2007 09/26/2007 [Insert *FR* page number where document begins] Reg. 19.1404 CAIR NO <sup>X</sup> Ozone Season Allowance Allocations 07/15/2007 09/26/2007 [Insert *FR* page number where document begins] Chapter 15—Effective Date Reg. 19.1501 Effective Date 07/15/2007 09/26/2007 [Insert *FR* page number where document begins] * * * * * * * [FR Doc. E7-18966 Filed 9-25-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R07-OAR-2007-0926; FRL-8471-9] Approval and Promulgation of Implementation Plans; State of Missouri AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: EPA is approving a revision to the Missouri State Implementation Plan
(SIP)that will fulfill the condition of a previously-published approval (July 11, 2006). The revision amends the Construction Permits By Rule and requires a preconstruction review period before sources may begin construction. DATES: This direct final rule will be effective November 26, 2007, without further notice, unless EPA receives adverse comment by October 26, 2007. If adverse comment is received, EPA will publish a timely withdrawal of the direct final rule in the **Federal Register** informing the public that the rule will not take effect. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-OAR-2007-0926, by one of the following methods: 1. *http://www.regulations.gov.* Follow the on-line instructions for submitting comments. 2. *E-mail:* *Algoe-Eakin.amy@epa.gov.* 3. *Mail:* Amy Algoe-Eakin, Environmental Protection Agency, Air Planning and Development Branch, 901 North 5th Street, Kansas City, Kansas 66101. 4. *Hand Delivery or Courier.* Deliver your comments to Amy Algoe-Eakin, Environmental Protection Agency, Air Planning and Development Branch, 901 North 5th Street, Kansas City, Kansas 66101. *Instructions:* Direct your comments to Docket ID No. EPA-R07-OAR-2007-0926. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.regulations.gov,* including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit through *http://www.regulations.gov* or e-mail information that you consider to be CBI or otherwise protected. The *http://www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *http://www.regulations.gov,* your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket:* All documents in the electronic docket are listed in the *http://www.regulations.gov* index. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in *http://www.regulations.gov* or in hard copy at the Environmental Protection Agency, Air Planning and Development Branch, 901 North 5th Street, Kansas City, Kansas 66101. The Regional Office's official hours of business are Monday through Friday, 8 to 4:30 excluding Federal holidays. The interested persons wanting to examine these documents should make an appointment with the office at least 24 hours in advance. FOR FURTHER INFORMATION CONTACT: Amy Algoe-Eakin at
(913)551-7942, or by e-mail at *Algoe-Eakin.amy@epa.gov.* SUPPLEMENTARY INFORMATION: Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This section provides additional information by addressing the following questions: What is a SIP? What is the Federal approval process for a SIP? What does Federal approval of a state regulation mean to me? What is being addressed in this document? Have the requirements for approval of a SIP revision been met? What action is EPA taking? What is a SIP? Section 110 of the Clean Air Act
(CAA)requires states to develop air pollution regulations and control strategies to ensure that state air quality meets the national ambient air quality standards (NAAQS) established by EPA. These ambient standards are established under section 109 of the CAA, and they currently address six criteria pollutants. These pollutants are: Carbon monoxide, nitrogen dioxide, ozone, lead, particulate matter, and sulfur dioxide. Each state must submit these regulations and control strategies to us for approval and incorporation into the federally-enforceable SIP. Each federally-approved SIP protects air quality primarily by addressing air pollution at its point of origin. These SIPs can be extensive, containing state regulations or other enforceable documents and supporting information such as emission inventories, monitoring networks, and modeling demonstrations. What is the Federal approval process for a SIP? In order for state regulations to be incorporated into the Federally-enforceable SIP, states must formally adopt the regulations and control strategies consistent with state and Federal requirements. This process generally includes a public notice, public hearing, public comment period, and a formal adoption by a state-authorized rulemaking body. Once a state rule, regulation, or control strategy is adopted, the state submits it to us for inclusion into the SIP. We must provide public notice and seek additional public comment regarding the proposed Federal action on the state submission. If adverse comments are received, they must be addressed prior to any final Federal action by us. All state regulations and supporting information approved by EPA under section 110 of the CAA are incorporated into the Federally-approved SIP. Records of such SIP actions are maintained in the Code of Federal Regulations
(CFR)at title 40, part 52, entitled “Approval and Promulgation of Implementation Plans.” The actual state regulations which are approved are not reproduced in their entirety in the CFR outright but are “incorporated by reference,” which means that we have approved a given state regulation with a specific effective date. What does Federal approval of a state regulation mean to me? Enforcement of the state regulation before and after it is incorporated into the Federally-approved SIP is primarily a state responsibility. However, after the regulation is Federally approved, we are authorized to take enforcement action against violators. Citizens are also offered legal recourse to address violations as described in section 304 of the CAA. What is being addressed in this document? EPA is approving a SIP revision submitted by the state of Missouri that will fulfill the condition of a previously-published approval (July 11, 2006). Missouri adopted a rule in June 2003 (10 CSR 10-6.062) to establish permits by rule for various source categories (e.g., printing operations, surface coating operations) which authorizes sources in categories covered by the rule to operate under specified conditions, instead of obtaining source-specific permits. The rule applies only to the minor source program. The original rule (see 71 FR 38997 for a detailed description of the rule and specific action by EPA on the rule) did not expressly include a mechanism for preconstruction review of applications received from facilities that wanted to operate under this rule. Section 110(a)(2)(C) of the CAA requires that each SIP include a program to regulate construction and modification of sources to ensure that the NAAQS are achieved. EPA's implementing regulation provides that the plan must include procedures, “by which the state . . . will prevent such construction or modification” where the source or modification would violate a control strategy or interfere with attainment or maintenance of the NAAQS (see 40 CFR 51.160(b)). Because Missouri's rule that was adopted on June 26, 2003, appeared to authorize construction to begin before any air quality review occurred, and the rule only provided for revocation of a permit after the source began construction or operation, EPA believed that Missouri's preconstruction permit program was deficient with respect to sources which may qualify for Permit By Rule. To correct the deficiency, the Missouri Department of Natural Resources was directed by the Missouri Air Conservation Commission via resolution on December 8, 2005, to revise the Permit By Rule to expressly include a preconstruction period of seven days before sources could begin construction. The purpose of the preconstruction period is to allow time for the state to review the application for the permit by rule and determine whether additional air quality analyses should be conducted for a particular project. The state must also approve the application before construction may begin. This revision establishes the seven day preconstruction period and fulfills the requirements of the conditional approval. Have the requirements for approval of a SIP revision been met? The state submittal has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submittal also satisfied the completeness criteria of 40 CFR part 51, appendix V. In addition, as explained above and in more detail in the technical support document which is part of this docket, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations. What action is EPA taking? EPA is approving a revision to the Missouri SIP to fulfill the condition of a previously-published approval (July 11, 2006). The revision includes a mechanism for preconstruction review of applications from facilities that want to operate under 10 CSR 10-6.062, the permit by rule. We do not anticipate any adverse comments. Please note that if EPA receives adverse comments on part of this rule, and if that part can be severed from the remainder of the rule, EPA may adopt as final those parts of the rule that are not the subject of an adverse comment. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Because this action approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This action also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This action also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal standard. In reviewing state submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a state submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a state submission, to use VCS in place of a state submission that otherwise satisfies the provisions of the CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the **Federal Register** . 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 26, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule 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).) List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds. Dated: September 13, 2007. John B. Askew, Regional Administrator, Region 7. Chapter I, title 40 of the Code of Federal Regulations is amended as follows: PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* Subpart AA—Missouri 2. In § 52.1320 the table in paragraph
(c)is amended by revising the entry for 10-6.062 to read as follows: § 52.1320 Identification of plan.
(c)* * * EPA-Approved Missouri Regulations Missouri citation Title State effective date EPA approval date Explanation Missouri Department of Natural Resources * * * * * * * Chapter 6 Air Quality Standards, Definitions, Sampling and Reference Methods, and Air Pollution Control Regulations for the State of Missouri * * * * * * * 10-6.062 Construction Permits By Rule. 5/30/07 9/26/07 [insert FR page number where the document begins] Section (3)(B)4 is not included in the SIP. * * * * * * * [FR Doc. E7-18792 Filed 9-25-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0522; FRL-8148-6] Pyraclostrobin; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for combined residues of pyraclostrobin and its desmethoxy metabolite in or on berry, group 13; cotton, undelinted seed; and cotton, gin byproducts. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective September 26, 2007. Objections and requests for hearings must be received on or before November 26, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2006-0522. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Tony Kish, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)308-9443; e-mail address: *kish.tony@epa.gov* . SUPPLEMENTARY INFORMATION: 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), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather 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 . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, 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-2006-0522 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before November 26, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2006-0522, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. II. Petition for Tolerance In the **Federal Register** of July 5, 2006 (71 FR 38150-38151) (FRL-8074-2), 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 5F7002) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.582 be amended by establishing tolerances for combined residues of the fungicide pyraclostrobin, (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenylcarbamate), expressed as parent compound, in or on berry, group 13 at 4.0 parts per million (ppm); cotton, undelinted seed at 0.4 ppm; and cotton, gin byproducts at 30 ppm. That notice referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available to the public 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 modified the tolerance for cotton, undelinted seed from 0.4 ppm to 0.3 ppm. The reason for this change is explained in Unit V. III. Aggregate Risk Assessment and Determination of Safety 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. . . .” These provisions were added to FFDCA by the Food Quality Protection Act
(FQPA)of 1996. 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 the petitioned-for tolerances for combined residues of pyraclostrobin and its desmethoxy metabolite on berry, group 13 at 4.0 ppm; cotton, undelinted seed at 0.3 pm; and cotton, gin byproducts at 30 ppm. EPA's assessment of exposures and risks associated with establishing the tolerances follows. A. Toxicological Profile 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. Pyraclostrobin has a low to moderate acute toxicity. In repeated dose oral toxicity studies, the main target organs for pyraclostrobin are the upper gastrointestinal tract (mainly the duodenum and stomach), the spleen/hematopoiesis, the immune system, and the liver. In addition, reduced body weight/gain and feed intake/efficiency are also common findings. In the developmental toxicity study in rabbits, there was evidence of increased qualitative susceptibility of *in utero* rabbits following exposure to pyraclostrobin (increases in resorptions/litter and post-implantation losses), but only at doses that also resulted in maternal toxicity (decreases in body weight gain and food consumption). There was no evidence of increased quantitative or qualitative susceptibility of *in utero* rats or offspring following exposure to pyraclostrobin. In the 2-generation reproduction study, the highest dose tested did not cause maternal systemic toxicity, nor did it elicit reproductive or offspring toxicity. In both the acute and subchronic neurotoxicity studies, there were no indications of treatment-related neurotoxicity. EPA has reevaluated the carcinogenic potential of pyraclostrobin in light of a new supplementary cancer study in female mice and concluded that, in accordance with the EPA's Final Guidelines for Carcinogen Risk Assessment (March, 2005), pyraclostrobin should be classified into the category “Not Likely to be Carcinogenic to Humans.” This determination is based on no treatment-related increase in tumors in either sex of rats and mice, which were tested at doses that were adequate to assess carcinogenicity, and the lack of evidence of mutagenicity. Specific information on the studies received and the nature of the adverse effects caused by pyraclostrobin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.regulations.gov* in the human health risk assessment document in the docket established by this action, which is described under ADDRESSES . The referenced document is identified as EPA-HQ-OPP-2006-0522-0002 in that docket. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern
(LOC)is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors
(UFs)are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose
(aPAD)and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. Short-, intermediate-, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure
(MOE)called for by the product of all applicable UFs is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. 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 pyraclostrobin used for human risk assessment can be found at *http://www.regulations.gov* in the human health risk assessment document identified as document number 0002 in docket ID number EPA-HQ-OPP-2006-0522. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to pyraclostrobin, EPA considered exposure under the petitioned-for tolerances as well as all existing pyraclostrobin tolerances in (40 CFR 180.582). EPA assessed dietary exposures from pyraclostrobin in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. EPA identified such an effect for the general population (decreased body weight gain seen after a single oral dose in the rat acute neurotoxicity study) and for females 13 to 49 years old (increased resorptions/litter and increased total resorptions seen in the rabbit developmental toxicity study that are presumed to occur after a single exposure). The aPAD for the general population has been established at 3.0 milligrams/kilograms/day (mg/kg/day); whereas, the aPAD for females 13 to 49 years old is significantly lower (0.05 mg/kg/day), due to the more sensitive endpoint on which it is based. In estimating acute dietary exposure, EPA used food consumption information from the U.S. Department of Agriculture
(USDA)1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed that residues are present at tolerance levels or at the highest residue level found in residue field trials. One hundred percent crop treated
(PCT)was assumed for all commodities in the assessment. Default processing factors were applied to all commodities except those for which experimentally-derived processing factors were available: Apple juice, grape juice, citrus juices, cottonseed oil, tomato paste, tomato puree, wheat flour, and wheat germ. 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 that residues are present at tolerance levels in all crops except grape, celery, spinach, tomato, pepper, citrus, apple, leaf lettuce and head lettuce. EPA relied on anticipated residues (average residues from field trials) for these crops. One hundred PCT was assumed for all commodities in the assessment. Default processing factors were applied to all commodities except those for which experimentally-derived processing factors were available: Apple juice, grape juice, citrus juices, cottonseed oil, tomato paste, tomato puree, wheat flour, and wheat germ. iii. *Cancer* . EPA has classified pyraclostrobin as “Not Likely to be Carcinogenic to Humans.” Therefore, a cancer exposure assessment 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 pursuant to section 408(f)(1) of FFDCA require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such Data Call-Ins as are required by section 408(b)(2)(E) of FFDCA and authorized under section 408(f)(1) of FFDCA. Data will be required to be submitted no later than 5 years from the date of issuance of this tolerance. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for pyraclostrobin in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of pyraclostrobin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Groundwater (SCI-GROW) models, the estimated environmental concentrations
(EECs)of pyraclostrobin for acute exposures are estimated to be 10.2 parts per billion
(ppb)for surface water and 0.02 ppb for ground water. The EECs for chronic exposures are estimated to be 0.8 ppb for surface water and 0.02 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 10.2 ppb was used to access the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 0.8 ppb was used to access the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Pyraclostrobin is currently registered for the following residential non-dietary sites: Residential and recreational turfgrass. EPA assessed residential exposure using the following assumptions: Residential and recreational turf applications are applied by professional pest control operators
(PCOs)only, and, therefore, residential handler exposures do not occur. There is, however, a potential for short- and intermediate-term postapplication exposure of adults and children entering lawn and recreation areas previously treated with pyraclostrobin. Exposures from treated recreational sites are expected to be similar to, or in many cases lower than, those from treated residential turf sites; therefore, a separate exposure assessment for recreational turf sites was not conducted. EPA assessed exposures from the following residential turf postapplication scenarios: i. Adult and toddler postapplication dermal exposure from contact with treated lawns, ii. Toddlers' incidental ingestion of pesticide residues on lawns from hand-to-mouth transfer, iii. Toddlers' object-to-mouth transfer from mouthing of pesticide-treated turfgrass, and iv. Toddlers' incidental ingestion of soil from pesticide-treated residential areas. The postapplication risk assessment was conducted in accordance with the Residential Standard Operating Procedures
(SOPs)and recommended approaches of the Health Effects Division's (HED's) Science Advisory Council for Exposure (ExpoSAC). 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to pyraclostrobin and any other substances and pyraclostrobin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that pyraclostrobin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional (“10X”) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . The prenatal and postnatal toxicology database for pyraclostrobin includes the rat and rabbit developmental toxicity studies and the 2-generation reproduction toxicity study in rats. There was no evidence of increased quantitative or qualitative susceptibility of *in utero* rats or offspring following exposure to pyraclostrobin in the rat developmental and reproduction studies. In the rabbit developmental study, there was evidence of increased qualitative susceptibility of *in utero* rabbits following exposure to pyraclostrobin (increases in resorptions/litter and post-implantation losses), but only at doses that also resulted in maternal toxicity (decreases in body weight gain and food consumption). 3. *Conclusion* . EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. The toxicity database for pyraclostrobin is complete. ii. There is no indication that pyraclostrobin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that pyraclostrobin results in increased susceptibility in *in utero* rats in the prenatal developmental study or in young rats in the 2-generation reproduction study. Although there is qualitative evidence of increased susceptibility in the prenatal developmental study in rabbits, the Agency did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of pyraclostrobin. The degree of concern for prenatal and/or postnatal toxicity is low. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues or anticipated residues derived from reliable field trial data. Conservative ground and surface water modeling estimates were used. Similarly, conservative Residential SOPs were used to assess post-application dermal exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by pyraclostrobin. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-, intermediate-, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, EPA performed two different acute risk assessments, one focusing on females 13 to 49 years old and designed to protect against prenatal effects and the other focusing on acute effects relevant to all other population groups. The more sensitive acute endpoint was seen as to prenatal effects rather than other acute effects. For females 13 to 49 years old, the acute dietary exposure from food and water will occupy 78% of the aPAD addressing prenatal effects. As to acute effects other than prenatal effects, the acute dietary exposure from food and water to pyraclostrobin will occupy 2.3% of the aPAD for children 1 to 2 years old, the population group with the highest estimated acute dietary exposure to pyraclostrobin. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to pyraclostrobin from food and water will utilize 48% of the cPAD for children 1 to 2 years old, the population group with the highest estimated exposure and risk. Based on the use pattern, chronic residential exposure to residues of pyraclostrobin is not expected. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Pyraclostrobin 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 food and water and short-term residential exposures for pyraclostrobin. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food, water, and residential exposures aggregated result in aggregate MOEs of 170 for adults and 100 for children, 1 to 2 years old. The aggregate MOE for adults is based on the residential turf scenario and includes combined food, drinking water and post-application dermal exposures. The aggregate MOE for children includes food, drinking water, post-application dermal and incidental oral exposures from entering turf areas previously treated with pyraclostrobin. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Pyraclostrobin 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 food and water and intermediate-term residential exposures for pyraclostrobin. Since the endpoints and points of departure (NOAELs) are identical for short- and intermediate-term exposures, the aggregate MOEs for intermediate-term exposure are the same as those for short-term exposure (170 for adults and 100 for children, 1 to 2 years old). 5. *Aggregate cancer risk for U.S. population* . EPA has classified pyraclostrobin into the category “Not Likely to be Carcinogenic to Humans.” Therefore, a cancer aggregate exposure assessment was not conducted. Pyraclostrobin 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 pyraclostrobin residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (an LC/MS/MS method (BASF Method D9808), and an HPLC/UV method (BASF Method D9904)) is available to enforce the tolerance expression. The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:
(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are no established or proposed Codex maximum residue limits
(MRLs)for pyraclostrobin. V. Conclusion EPA determined that the proposed tolerance level for “cotton, undelinted seed” of 0.4 ppm should be revised to 0.3 ppm based on review of the supporting residue field trial data. As the majority of cottonseed samples had residues below the limit of quantitation
(LOQ)of the method (0.04 ppm), the recommended tolerance for undelinted seed could not be determined using the Agency's Tolerance/MRL Harmonization Spreadsheet. Rather, the recommended tolerance of 0.3 ppm is based on the maximum combined residues of pyraclostrobin and its desmethoxy metabolite observed in seeds (0.17 ppm). Therefore, the tolerances are established for combined residues of pyraclostrobin, (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite, (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenylcarbamate), expressed as parent compound, in or on berry, group 13 at 4.0 ppm; cotton, undelinted seed at 0.3 ppm; and cotton, gin byproducts at 30 ppm, respectively. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) 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 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act 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). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: September 18, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.582 is amending paragraph (a)(1) in the table as follows: i. By revising the entry for “Berry group 13”; and ii. By alphabetically adding “Cotton, gin byproducts” and “Cotton, undelinted seed.” The amendments read as follows: § 180.582 Pyraclostrobin; tolerances for residues.
(a)*General* .
(1)* * * Commodity Parts per million * * * * * Berry, group 13 4.0 * * * * * Cotton, gin byproducts 30 Cotton, undelinted seed 0.3 * * * * * [FR Doc. E7-18858 Filed 9-25-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0206; FRL-8147-4] Sulfosulfuron; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of sulfosulfuron in or on grass, forage, fodder, and hay group 17, forage, and grass, forage, fodder, and hay, group 17, hay. This regulation also increases tolerances for fat, meat, and meat by byproducts of cattle, goat, horse, and sheep, and milk. Monsanto Company requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective September 26, 2007. Objections and requests for hearings must be received on or before November 26, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2006-0206. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Vickie Walters, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-5704; e-mail address: *walters.vickie@epa.gov* . SUPPLEMENTARY INFORMATION: 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), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather 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 . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, 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-2006-0206 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before November 26, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2006-0206, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. II. Petition for Tolerance In the **Federal Register** of July 14, 2006 (71 FR 40106) (FRL-8057-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F7031) by Monsanto Company, 1300 I St., NW., Suite 450 East, Washington, DC 20005. The petition requested that 40 CFR 180.552 be amended by establishing a tolerance for residues of the herbicide sulfosulfuron, 1-(4,6-dimethoxypyrimidin-2-yl)-3-[(2-ethane-sulfonyl-imidazo[1,2-a]pyridine-3-yl)sulfonyl]urea, and its metabolites converted to 2-(ethylsulfonyl)imidazol[1,2-a]pyridine and calculated at sulfosulfuron, in or on grass, forage at 13.0 parts per million (ppm); grass, hay at 14 ppm; milk at 0.02 ppm; fat of cattle, goat, horse, and sheep at 0.03 ppm; meat of cattle, goat, horse, and sheep at 0.01 ppm; and meat byproducts of cattle, goat, horse, and sheep at 0.4 ppm. . That notice referenced a summary of the petition prepared by Monsanto Company, the registrant, which is available to the public 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 and Agency procedures concerning commodity names, the Agency is correcting the terminology and tolerance level for pending crops under 40 CFR 180.552
(a)as follows: Grass, forage, fodder and hay, group 17, forage at 14 ppm; grass, forage, fodder and hay, group 17, hay at 25 ppm; cattle, fat at 0.02 ppm; cattle, meat at 0.01; cattle, meat byproducts at 0.30; goat, fat at 0.02 ppm; goat, meat at 0.01 ppm; goat, meat byproducts at 0.30; horse, fat at 0.02 ppm; horse, meat at 0.01 ppm; horse, meat byproducts at 0.30; milk at 0.02; sheep, fat at 0.02 ppm; sheep, meat at 0.01 ppm; and sheep; meat byproducts at 0.30 ppm. These entries will replace current entries for cattle, fat; cattle, meat; cattle, meat byproduct; goat, fat; goat, meat; goat, meat byproducts, horse, fat; horse, meat; horse; meat byproduct; milk; sheep; fat; sheep, meat; and sheep, meat byproducts listed in paragraphs 40 CFR 180. 552(a) and (b). The current entries listed in 180.552
(b)for bahiagrass, forage at 11 ppm; bahiagrass, hay at 40 ppm; bermudagrass, forage at 11 ppm; and bermudagrass, hay at 40 ppm are replaced by the entries for grass, forage, fodder and hay, group 27, forage at 14 ppm; and grass, forage, fodder and hay, group 17, hay at 25 ppm in 40 CFR 180.552 (a). III. Aggregate Risk Assessment and Determination of Safety 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. . . .” These provisions were added to FFDCA by the Food Quality Protection Act
(FQPA)of 1996. 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 the petitioned-for tolerance for residues of sulfosulfuron on grass, forage, fodder and hay, group 17, forage at 14 ppm; grass, forage, fodder and hay, group 17, hay at 25 ppm; cattle, fat 0.02 ppm; cattle, meat at 0.01; cattle, meat byproducts at 0.3; goat, fat at 0.02 ppm; goat, meat at 0.01 ppm; goat, meat byproducts at 0.3; horse, fat at 0.02 ppm; horse, meat at 0.01 ppm; horse, meat byproducts at 0.3; milk at 0.02; sheep, fat at 0.02 ppm; sheep, meat at 0.01 ppm; and sheep; meat byproducts at 0.3 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by sulfosulfuron 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 May 19, 1999 (64 FR 27186 (FRL-6078-4). B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern is derived from the highest dose at which no adverse effects are observed in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified is sometimes used for risk assessment. Uncertainty/safety factors
(UFs)are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose
(aPAD)and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure
(MOE)called for by the product of all applicable UFs is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . A summary of the toxicological endpoints for sulfosulfuron used for human risk assessment is discussed in Unit IV.A. of the final rule published in the **Federal Register** of November 16, 2005 (70 FR 69457) (FRL-7740-1) C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to sulfosulfuron, EPA considered exposure under the petitioned-for tolerances as well as all existing sulfosulfuron tolerances in (40 CFR 180.552). EPA assessed dietary exposures from sulfosulfuron in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for sulfosulfuron; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the Unired States Department of Agriculture
(USDA)1994-1996, or 1998 Continuing Survey of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues and Dietary Exposure Evalutation Model
(DEEM)(version 7.76) default processing factors. iii. *Cancer* . In accordance with the Agency's Proposed Guidelines for Carcinogenic Risk Assessment (April 10, 1996), the CARC classified sulfosulfuron as a likely human carcinogen. The weight-of-evidence for this classification are as follows: • Occurrence of rare transitional cell papilloma and cancinoma of urinary bladder in female rats. • Occurrence of rare benign mesenchymal tumors of the urinary bladder in high dose male as well as renal adenomas in female and possibly male mice. • The relevancy of the observed tumors to human exposure. The Agency determined that a linear low-dose approach (Q 1*) for human risk characterization and extrapolation of risk should be based on the incidence of benign mesenchymal tumors in male mice. The rat transitional tumors and mouse renal tumors were not used because of their low incidence. This extrapolation, rather than an MOE approach is supported by the lack of sufficient data to characterize the mechanism of carcinogencity. The unit risk, Q 1* milligram/kilogram/day (mg/kg/day) - 1 of sulfosulfuron based upon male mouse urinary bladder mescenchmal tumor rates is 1.03 X 10 - 3 (mg/kg/day) - 1 in human equivalents. The cancer dietary analysis assumed tolerance level residues, 100% CT and DEEM (version 7.76) default processing factors. 2. *Dietary exposure from drinking water* .The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for sulfosulfuron in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of sulfosulfuron. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of sulfosulfuron for acute exposures are estimated to be 10.41 parts per billion
(ppb)for surface water and 2.6 ppb for ground water. The EWDCs for chronic exposures are estimated to be 1.12 ppb for surface water and 2.6 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 2.6 ppb was used to access the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Residential exposure is not expected for the new proposed uses. However sulfosulfuron is registered for use on turf. Residential homeowners are not expected to handle sulfosulfuron directly. However, sulfosulfuron is applied by professional commercial operators to lawn areas (such as apartment complexes, parks, schools, recreational areas and public areas) where residents would come into contact with sulfosulfuron residues. Therefore, as a part of a previous risk assessment for this herbicide, post application exposure and risk to residents (adults and children) were assessed. Post-application inhalation exposure to children is considered to be negligible. Non-dietary, incidental ingestion of residues from treated turfgrass and ingestion of contaminated soil are possible. To address the short-term residential risk to children from incidental oral exposure, the Agency used the NOAEL of 24 mg/kg/day from the combined chronic toxicity/carcinogenicity study in rats. This NOAEL is considered conservative and health protective for this assessment because it represents the lowest NOAEL in most sensitive species (the basis for the Chronic Reference Dose (cRfD)). Agency SOPs for Residential Exposure Assessments (Draft, December 18, 1997) were used as a guideline for performing the residential post-application exposure (with amendments, 2001). Children's hand-to-mouth, object to mouth (turfgrass) and soil ingestion were assessed. As discussed above, there are no residential handler uses for sulfosulfuron. Therefore, the residential cancer assessment for adults considered post-application only. Cancer risk for residential adults was calculated based on high activity on treated lawns. A transfer coefficient
(TC)of 1,000 cm 2 /hr was used. Several conservative assumptions are built into the assessment of residential cancer risk. These include fifty years of exposure and an estimated 20% of foliar residues being dislodgeable
(DFRs)from turf, which is derived from the maximum application rate. An average of 14 days of DFRs were used for this cancer assessment, this would be considered a 10% decrease each day (from dilution by rain, and mowing or grass) of the 20% residue for at least 14 days, and then taking the mean value of this 14-day exposure. It should be noted that the current default DFR is 5% from turf. At the time of the last risk assessment, the Agency assumed 20% DFR as a default. As a result, the estimate of residential adult risk is more conservative than it would be otherwise. The Lifetime Average Daily Dose
(LADD)= 6.0 X 10 - 5 mg/kg/day for a TC of 1,000 cm 2 /hr (high exposure activity for 1 hour). 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to sulfosulfuron and any other substances and sulfosulfuron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that sulfosulofuron has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional (“10X”) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . The developmental studies in rat and rabbit and the reproductive study in rats did not indicate increased susceptibility of rats or rabbits *in utero* and/or postnatal exposure. 3. *Conclusion* . EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. The toxicity database for sulfosulfuron is complete. ii. There is no indication that sulfosulfuron is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that sulfosulfuron results in increased susceptibility in *in utero* rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues Conservative ground water and surface water modeling estimates were used. Similarly conservative Residential SOPs were used to assess post-application exposure to children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by sulfosulfuron. E. Aggregate Risks and Determination of Safety. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. *Acute risk* . An endpoint was not selected for acute dietary risk assessment because there were no effects attributable to a single dose (exposure) observed in oral toxicology studies (including developmental toxicity studies in the rat and rabbit (at or up to 1,000 mg/kg/day)) and an acute neurotoxicity study in rat (at or up to 2, 000 mg/kg/day). The acute oral toxicity of sulfosulfuron is also very low. Therefore, sulfosulfuron is not expected to pose an acute risk. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to sulfosulfuron from food and water will utilize < 1% of the cPAD for all population subgroups including infants and children. Based the use pattern, chronic residential exposure to residues of sulfosulfuron is not expected. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Sulfosulfuron is currently registered for use(s) that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for sulfosulfuron. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food, water, and residential exposures aggregated result in an aggregate MOE of 1,300 for children 1-2 years old. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Though residential exposure could occur no toxicological effects have been identified for intermediate-term toxicity. Therefore, the aggregate risk is the sum of the risk from food and water. 5. *Aggregate cancer risk for U.S. population* . The cancer aggregate risk assessment considered exposure from food, water, and residential sources. EPA performs cancer assessments for the general U.S. population only. The cancer dietary analyses assumed tolerance level residues, 100% CT, and DEEM (version 7.76) default processing factors. The dietary cancer risk from drinking water and food for the U.S. population was 3 X 10 - 7 . Residential cancer risk was estimated for adults only based on dermal exposure to treated areas. The estimated cancer risk for adults on day zero, based on high-exposure activity for one hour (Tc=1,000 cm 2 /hr) is estimated to be 1.2 X 10 - 7 . The aggregate cancer risk estimate for adults is 3 X 10 - 7 . If childhood incidental oral exposure from residential sources is included in the aggregate cancer risk assessment, the estimated cancer risk is 4 X 10 - 7 . Since the cancer risk is less than the negligible risk level of risks in the range of or below 1 X 10 - 6 , EPA does not have a concern for aggregate cancer risk from sulfosulfuron. 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 sulfosulfuron residues. IV. Other Considerations A. Analytical Enforcement Methodology In support of the use on wheat, the petitioner proposed two common-moiety high-performance liquid chromatography
(HPLC)methods with fluorescence detection for enforcement of tolerances in wheat and livestock commodities. For grasses the company used a common moiety liquid chromatograph/mass spectrometry/mass spectrometry (LC/MS/MS) method. The validated limit of quantitation
(LOQ)was 0.005 and the limit of detection
(LOD)was 0.0026. The revision of the original HPLC enforcement method to use LC/MC detection resolves the previous deficiencies related to the specificity and confirmatory method. These deficiencies are no longer outstanding. Adequate enforcement methodology LC/MS/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* . B. International Residue Limits There are no established or proposed Codex or Mexican maximum residue limits
(MRLs)for residues of sulfosulfuron in grasses or wheat. There are no established Canadian MRLs for residues of sulfosulfuron in grasses. A Canadian MRL has been established for residues of sulfosulfuron in wheat. V. Conclusion Therefore, tolerances are established for residues of sulfosulfuron, 1-(4,6-dimethoxypyrimidin-2-yl)-3-[(2-ethane-sulfonyl-imidazo[1,2-a]pyridine-3-yl)sulfonyl]urea, and its metabolites converted to 2-(ethylsulfonyl)imidazol[1,2-a]pyridine and calculated at sulfosulfuorn, as discussed in Unit II. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) 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 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act 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). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: September 13, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.552 is amended by revising the table in paragraph (a), and by removing the text and reserving paragraph
(b)to read as follows: § 180.552 Sulfosulfuron; tolerances for residues.
(a)* * * Commodity Parts per million Cattle, fat 0.02 Cattle, meat 0.01 Cattle, meat byproducts 0.3 Goat, fat 0.02 Goat, meat 0.01 Goat, meat byproducts 0.3 Grass, forage, fodder and hay, group 17, forage 14 Grass, forage, fodder and hay, group 17, hay 25 Hog, fat 0.005 Hog, meat 0.005 Hog, meat byproducts 0.05 Horse, fat 0.02 Horse, meat 0.01 Horse, meat byproducts 0.3 Milk 0.02 Sheep, fat 0.02 Sheep, meat 0.01 Sheep, meat byproducts 0.3 Wheat, forage 4.0 Wheat, grain 0.02 Wheat, hay 0.3 Wheat, straw 0.1
(b)*Section 18 emergency exemptions* . [Reserved] [FR Doc. E7-18864 Filed 9-25-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0261; FRL-8147-6] Methamidophos, Oxydemeton-methyl, Profenofos, and Trichlorfon; Tolerance Actions AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: EPA is revoking certain tolerances for the insecticide oxydemeton-methyl. Also, EPA is modifying certain tolerances for the insecticides oxydemeton-methyl, profenofos, and trichlorfon. In addition, EPA is establishing new tolerances for the insecticides oxydemeton-methyl and profenofos. EPA is not taking action on tolerances for methamidophos at this time. The regulatory actions finalized in this document are follow-up to the Agency's reregistration program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and tolerance reassessment program under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q). DATES: This regulation is effective September 26, 2007. Objections and requests for hearings must be received on or before November 26, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2007-0261. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)308-8037; e-mail address: *nevola.joseph@epa.gov* . SUPPLEMENTARY INFORMATION: 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: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this “ **Federal Register** ” document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, as amended by the Food, Quality, Protection Act (FQPA), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-0261 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 26, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2007-0261, by one of the following methods. • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. II. Background A. What Action is the Agency Taking? In the **Federal Register** of May 23, 2007 (72 FR 28912) (FRL-8130-8), EPA issued a proposal to revoke, remove, modify, and establish certain specific tolerances for residues of the insecticides methamidophos, oxydemeton-methyl, profenophos, and trichlorfon. Also, the proposal of May 23, 2007 (72 FR 28912) provided a 60-day comment period which invited public comment for consideration and for support of tolerance retention under FFDCA standards. In this final rule, EPA is revoking, removing, modifying, and establishing specific tolerances for residues of oxydemeton-methyl, profenofos, and trichlorfon in or on commodities listed in the regulatory text of this document. EPA is finalizing these tolerance actions in order to implement the tolerance recommendations made during the reregistration and tolerance reassessment processes (including follow-up on canceled or additional uses of pesticides). As part of these processes, EPA is required to determine whether each of the amended tolerances meets the safety standard of FFDCA. The safety finding determination of “reasonable certainty of no harm” is discussed in detail in each Reregistration Eligibility Decision
(RED)and Report on FQPA Tolerance Reassessment Progress and Interim Risk Management Decision
(TRED)for the active ingredient. REDs and TREDs recommend the implementation of certain tolerance actions, including modifications, to reflect current use patterns, to meet safety findings and change commodity names and groupings in accordance with new EPA policy. Printed copies of many REDs and TREDs may be obtained from EPA's National Service Center for Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH 45242-2419, telephone number: 1-800-490-9198; fax number: 1-513-489-8695; Internet at *http://www.epa.gov/ncepihom* and from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, telephone number: 1-800-553-6847 or
(703)605-6000; Internet at *http://www.ntis.gov.* Electronic copies of REDs and TREDs are available on the Internet at *http://www.regulations.gov* and *http://www.epa.gov/pesticides/reregistration/status.htm* . In this final rule, EPA is revoking certain tolerances and/or tolerance exemptions because either they are no longer needed or are associated with food uses that are no longer registered under FIFRA in the United States. Those instances where registrations were canceled were because the registrant failed to pay the required maintenance fee and/or the registrant voluntarily requested cancellation of one or more registered uses of the pesticide active ingredient. The tolerances revoked by this final rule are no longer necessary to cover residues of the relevant pesticides in or on domestically treated commodities or commodities treated outside but imported into the United States. It is EPA's general practice to issue a final rule revoking those tolerances and tolerance exemptions for residues of pesticide active ingredients on crop uses for which there are no active registrations under FIFRA, unless any person who comments on the proposal indicates a need for the tolerance or tolerance exemption to cover residues in or on imported commodities or legally treated domestic commodities. Historically, EPA has been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Generally, EPA will proceed with the revocation of these tolerances on the grounds discussed in Unit II.A. if one of the following conditions applies: 1. Prior to EPA's issuance of a FFDCA section 408(f) order requesting additional data or issuance of a FFDCA section 408(d) or
(e)order revoking the tolerances on other grounds, commenters retract the comment identifying a need for the tolerance to be retained. 2. EPA independently verifies that the tolerance is no longer needed. 3. The tolerance is not supported by data that demonstrate that the tolerance meets the requirements under FQPA. This final rule does not revoke those tolerances for which EPA received comments stating a need for the tolerance to be retained. In response to the proposal published in the **Federal Register** of May 23, 2007 (72 FR 28912), EPA received comments only concerning methamidophos during the 60-day public comment period. 1. *Methamidophos* . EPA will not take action on methamidophos tolerances in 40 CFR 180.315 or amend 40 CFR 180.3 on tolerances for related pesticide chemicals at this time based on the comments. The Agency will respond to comments about methamidophos that were received during the public comment period and address methamidophos actions in a future notice to be published in the **Federal Register** . The Agency did not receive any specific comments, during the 60-day comment period, on the following pesticide active ingredients: Oxydemeton-methyl, profenofos, and trichlorfon. Therefore, EPA is finalizing the amendments proposed concerning these active ingredients in the **Federal Register** of May 23, 2007 (72 FR 28912). For a detailed discussion of the Agency's rationale for the establishments, revocations, and modifications to the tolerances, refer to the proposed rule of May 23, 2007. In addition, the Agency is making the following revision in this final rule. 2. *Oxydemeton-methyl* (ODM). EPA did not propose in a notice for comment to revise the tolerance nomenclature for ODM in 40 CFR 180.330(a)(1) from filbert to hazelnut, as is current Agency practice. However, section 553(b)(3)(B) of the Administrative Procedure Act provides that notice and comment is not necessary “when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefore in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” Consequently, for good cause, EPA is revising the tolerance terminology in 40 CFR 180.330(a)(1) from filbert to hazelnut. The reason for taking this action is because such action has no practical impact on the use of or exposure to the pesticide active ingredient, ODM, in or on that commodity and is made such that the tolerance terminology will conform to current Agency practice. B. What is the Agency's Authority for Taking this Action? EPA may issue a regulation establishing, modifying, or revoking a tolerance under FFDCA section 408(e). In this final rule, EPA is establishing, modifying, and revoking tolerances to implement the tolerance recommendations made during the reregistration and tolerance reassessment processes, and as follow-up on canceled uses of pesticides. As part of these processes, EPA is required to determine whether each of the amended tolerances meets the safety standards under FFDCA. The safety finding determination is found in detail in each post-FQPA RED and TRED for the active ingredient. REDs and TREDs recommend the implementation of certain tolerance actions, including modifications to reflect current use patterns, to meet safety findings, and change commodity names and groupings in accordance with new EPA policy. Printed and electronic copies of the REDs and TREDs are available as provided in Unit II.A. EPA has issued post-FQPA REDs for methamidophos, oxydemeton-methyl, and profenofos, and a TRED for trichlorfon, whose RED was completed prior to FQPA. REDs and TREDs contain the Agency's evaluation of the database for these pesticides, including statements regarding additional data on the active ingredients that may be needed to confirm the potential human health and environmental risk assessments associated with current product uses, and REDs state conditions under which these uses and products will be eligible for reregistration. The REDs and TREDs recommended the establishment, modification, and/or revocation of specific tolerances. RED and TRED recommendations such as establishing or modifying tolerances, and in some cases revoking tolerances, are the result of assessment under the FFDCA standard of “reasonable certainty of no harm.” However, tolerance revocations recommended in REDs and TREDs that are made final in this document do not need such assessment when the tolerances are no longer necessary. EPA's general practice is to revoke tolerances for residues of pesticide active ingredients on crops for which FIFRA registrations no longer exist and on which the pesticide may therefore no longer be used in the United States. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Nonetheless, EPA will establish and maintain tolerances even when corresponding domestic uses are canceled if the tolerances, which EPA refers to as “import tolerances,” are necessary to allow importation into the United States of food containing such pesticide residues. However, where there are no imported commodities that require these import tolerances, the Agency believes it is appropriate to revoke tolerances for unregistered pesticides in order to prevent potential misuse. When EPA establishes tolerances for pesticide residues in or on raw agricultural commodities, the Agency gives consideration to possible pesticide residues in meat, milk, poultry, and/or eggs produced by animals that are fed agricultural products (for example, grain or hay) containing pesticides residues (40 CFR 180.6). If there is no reasonable expectation of finite pesticide residues in or on meat, milk, poultry, or eggs, then tolerances do not need to be established for these commodities (40 CFR 180.6(b) and 180.6(c)). C. When Do These Actions Become Effective? These actions become effective on the date of publication of this final rule in the **Federal Register** . For this final rule, the tolerances that were revoked because registered uses did not exist concerned uses which have been canceled, in some cases, for many years. The Agency believes that existing stocks of pesticide products labeled for the uses associated with the revoked tolerances have been completely exhausted and that treated commodities have had sufficient time for passage through the channels of trade. Any commodities listed in the regulatory text of this document that are treated with the pesticides subject to this final rule, and that are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by FQPA. Under this unit, any residues of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration that: 1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA. 2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance. Evidence to show that food was lawfully treated may include records that verify the dates that the pesticide was applied to such food. III. Are There Any International Trade Issues Raised by this Final Action? 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, as required by section 408(b)(4) of FFDCA. 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 in a notice published for public comment. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual REDs and TREDs, and in the Residue Chemistry document which supports the RED and TRED, as mentioned in the proposed rule cited in Unit II.A. Specific tolerance actions in this rule and how they compare to Codex MRLs (if any) are discussed in Unit II.A. of the proposal. IV. Statutory and Executive Order Reviews In this final rule, EPA establishes tolerances under FFDCA section 408(e), and also modifies and revokes specific tolerances established under FFDCA section 408. The Office of Management and Budget
(OMB)has exempted these types of actions (i.e., establishment and modification of a tolerance and tolerance revocation for which extraordinary circumstances do not exist) from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). Nor does it require any special considerations as required by Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-13, section 12(d) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq* .), the Agency previously assessed whether establishment of tolerances, exemptions from tolerances, raising of tolerance levels, expansion of exemptions, or revocations might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. These analyses for tolerance establishments and modifications, and for tolerance revocations were published on May 4, 1981 (46 FR 24950) and on December 17, 1997 (62 FR 66020) (FRL-5753-1), respectively, and were provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticides listed in this rule, the Agency hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities. In a memorandum dated May 25, 2001, EPA determined that eight conditions must all be satisfied in order for an import tolerance or tolerance exemption revocation to adversely affect a significant number of small entity importers, and that there is a negligible joint probability of all eight conditions holding simultaneously with respect to any particular revocation. (This Agency document is available in the docket, as mentioned in Unit II.A.). Furthermore, for the pesticides named in this final rule, the Agency knows of no extraordinary circumstances that exist as to the present revocations that would change EPA's previous analysis. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. V. Congressional Review Act 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). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: September 13, 2007. Anne E. Lindsay, Acting Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.198 is revised to read as follows: § 180.198 Trichlorfon; tolerances for residues.
(a)*General* . Tolerances are established for residues of the insecticide trichlorfon (dimethyl (2,2,2-trichloro-1-hydroxyethyl) phosphonate) in or on the following food commodities: Commodity Parts per million Cattle, fat 1 0.5 Cattle, meat 1 0.2 Cattle, meat byproducts 1 0.1 1 There are no U.S. registrations for cattle commodities as of June 24, 1999.
(b)*Section 18 emergency exemptions* . [Reserved]
(c)*Tolerances with regional registrations* . [Reserved]
(d)*Indirect or inadvertent residues* . [Reserved] 3. Section 180.330 is revised to read as follows: § 180.330 S-(2-(Ethylsulfinyl)ethyl) O,O-dimethyl phosphorothioate; tolerances for residues.
(a)*General* .
(1)Tolerances are established for the combined residues of the insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)ethyl) O,O-dimethyl phosphorothioate) and its metabolite oxydemeton-methyl sulfone in or on the following food commodities: Commodity Parts per million Alfalfa, forage 5.0 Alfalfa, hay 11.0 Bean, lima 0.2 Beet, sugar, roots 0.3 Beet, sugar, tops 0.5 Broccoli 1.0 Brussels sprouts 1.0 Cabbage 2.0 Cauliflower 1.0 Clover, forage 5.0 Clover, hay 10.0 Corn, sweet, forage 1.0 Corn, sweet, kernel plus cob with husks removed 0.5 Corn, sweet, stover 3.0 Cotton, undelinted seed 0.02 Cucumber 1.0 Eggplant 1.0 Grapefruit 1.0 Hazelnut 0.05 Lemon 1.0 Lettuce, head 2.0 Melon 0.2 Onion, bulb 0.05 Orange 1.0 Pepper 0.75 Peppermint, tops 12.5 Pumpkin 0.2 Safflower, seed 1.0 Sorghum, forage, forage 2.0 Sorghum, grain, forage 2.0 Sorghum, grain, grain 0.75 Spearmint, tops 12.5 Squash, summer 1.0 Squash, winter 0.3 Strawberry 2.0 Walnut 0.05
(2)Tolerances are established for the combined residues of the insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)ethyl) O,O-dimethyl phosphorothioate) and its cholinesterase-inhibiting metabolites in or on the following food commodities: Commodity Parts per million Cattle, fat 0.01 Cattle, meat 0.01 Cattle, meat byproducts 0.01 Egg 0.01 Goat, fat 0.01 Goat, meat 0.01 Goat, meat byproducts 0.01 Hog, fat 0.01 Hog, meat 0.01 Hog, meat byproducts 0.01 Horse, fat 0.01 Horse, meat 0.01 Horse, meat byproducts 0.01 Milk 0.01 Poultry, fat 0.01 Poultry, meat 0.01 Poultry, meat byproducts 0.01 Sheep, fat 0.01 Sheep, meat 0.01 Sheep, meat byproducts 0.01
(b)*Section 18 emergency exemptions* . [Reserved]
(c)*Tolerances with regional registrations* . Tolerances with regional registrations, as defined in § 180.1(m), are established for the combined residues of the insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)-ethyl) O,O-dimethyl phosphorothioate) and its metabolite oxydemeton-methyl sulfone in or on the following food commodities: Commodity Parts per million Broccoli raab 2.0
(d)*Indirect or inadvertent residues* . [Reserved] 4. Section 180.404 is amended by revising paragraph
(a)to read as follows: § 180.404 Profenofos; tolerances for residues.
(a)*General* . Tolerances are established for residues of the insecticide profenofos (O-(4-bromo-2-chlorophenyl)-O-ethyl-S-propyl phosphorothioate) in or on the following food commodities: Commodity Parts per million Cattle, fat 0.05 Cattle, meat 0.05 Cattle, meat byproducts 0.05 Cotton, gin byproducts 55.0 Cotton, undelinted seed 2.0 Goat, fat 0.05 Goat, meat 0.05 Goat, meat byproducts 0.05 Horse, fat 0.05 Horse, meat 0.05 Horse, meat byproducts 0.05 Milk 0.01 Sheep, fat 0.05 Sheep, meat 0.05 Sheep, meat byproducts 0.05 [FR Doc. E7-18869 Filed 9-25-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0146; FRL-8147-2] Alachlor; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation revises and separates the tolerances for alachlor in § 180.249 into paragraphs
(a)through (d). This regulation also establishes several new tolerances under paragraph (a). It further establishes several new tolerances under paragraph (d). Details of these changes are outlined in Unit II. of this document. Monsanto Company requested these changes as submitted by petitions to EPA pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective September 26, 2007. Objections and requests for hearings must be received on or before November 26, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2007-0146. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Vickie Walters, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-5704; e-mail address: *walters.vickie@epa.gov* . SUPPLEMENTARY INFORMATION: 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), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather 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 . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, 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-2007-0146 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before November 26, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2007-0146, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. II. Petition for Tolerance In the **Federal Register** of May 9, 2007 (72 FR 26372) (FRL-8121-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 0F2348, 9F3776, 3F4179, 8F5000, 8F5025) by Monsanto Company, 1300 I St., NW., Suite 450 East, Washington, DC 2005. The petitions requested that 40 CFR 180.249 be amended by establishing a tolerance for residues of the herbicide alachlor (2-chloro-2',6'-diethyl- *N* -(methoxymethyl)acetanilide)and its metabolites which can be converted to 2,6-diethylaniline
(DEA)or 2-ethyl-6-(1-hydroxyethyl)aniline
(HEEA)upon basic hydrolysis, calculated as alachlor, in or on corn, fodder, and corn, forage at 2.0 ppm (0F2348); soybean at 1.0 ppm (9F3776); beans, dry and beans, succulent lima at 0.1 ppm; cowpea, forage and cowpea, hay at 5.0 ppm (3F4179); cotton, gin byproducts at 0.7 ppm; cotton, undelinted seed at 0.03 ppm; sunflower, seed at 2.5 ppm; and in the processed commodity sunflower, seed meal at 3.4 ppm (8F5000); grain, cereal group 15, except corn, rice, and sorghum forage at 0.05 ppm; grain, cereal, forage, fodder, and straw, group 16, except corn, rice, and sorghum forage at 0.6 ppm; hay and straw at 0.8 ppm; and nongrass animal feed, crop group 18, forage at 1.4 ppm and hay at 1.2 ppm (8F5025). PP 3F4179 also proposed that the current tolerances for bean, forage and bean, hay at 0.2 ppm be revoked, as these are no longer significant animal feed commodities. That notice referenced a summary of the petitions prepared by Monsanto Company, the registrant, which is available to the public 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 petitions, EPA is increasing the tolerance for peanut to 0.5 ppm. This tolerance will be listed in § 180.249(a). The Agency is correcting the tolerance expression for § 180.249(a) to read “Tolerances are established for combined residues of the herbicide alachlor (2-chloro-2',6'-diethyl- *N* -(methoxymethyl)acetanilide) and its metabolites which can be converted to 2,6-diethylaniline
(DEA)or 2-ethyl-6-(1-hydroxyethyl)aniline (1-HEEA) upon basic hydrolysis, calculated as alachlor in or on the following food commodities:” The terminology for the current listings of corn, fresh, kernel plus cob with husk removed; sorghum, forage; and sorghum, grain (milo); are being updated to read corn, sweet (K+CWHR); sorghum, grain, forage; and sorghum, grain, grain; to conform to Agency procedures. Pending tolerances for beans, dry at 0.1 ppm and beans, succulent lima at 0.1 will replace the current entries for bean, dry, seed and bean, lima, succulent. These tolerances will be listed in paragraph (a). Based upon Agency procedures concerning commodity names, the Agency is correcting the pending crops under § 180.249(a) as follows: Corn, field, forage at 2.0 ppm; corn, field, grain at 0.2 ppm; corn, field, stover at 2.0 ppm; corn, field, pop at 0.2 ppm; corn, pop, stover at 2.0 ppm; corn, sweet, forage at 2.0 ppm; corn, sweet, stover at 2.0 ppm; soybeans, seed at 1.0 ppm and sunflower, meal at 3.4 ppm. These listings will replace current listings for corn, forage; corn, grain; corn, stover; and soybean. The Agency also determined that the pending rotational crop tolerances should be placed in § 180.249(d) *Indirect and inadvertent residues* . The tolerance expression and commodity listing for § 180.249
(d)is revised to read: Tolerances are also established for indirect or inadvertent residues of alachlor (2-chloro-2',6'-diethyl- *N* -(methoxymethyl)acetanilide) and its metabolites which can be converted to 2,6-diethylaniline
(DEA)or 2-ethyl-6-(1-hydroxyethyl)aniline (1-HEEA) upon basic hydrolysis, calculated as alachlor in or on the following raw agricultural commodities when present therein as a result of application of alachlor to the growing crops listed in paragraph
(a)of this section animal feed, nongrass, group 18, forage at 1.4 ppm; animal feed, nongrass, group 18, hay at 1.2 ppm; grain, cereal, group 15 except corn, sorghum, rice at 0.05 ppm; grain, cereal, forage, fodder, and straw, group 16 except corn, sorghum, and rice, forage at 0.6 ppm; grain, cereal, forage, fodder and straw, group 16 except corn, sorghum, and rice, hay at 0.8 ppm; and grain, cereal, forage, fodder, and straw, group 16 except corn, sorghum, and rice, straw at 0.8 ppm. III. Aggregate Risk Assessment and Determination of Safety 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. . . .” These provisions were added to FFDCA by the Food Quality Protection Act
(FQPA)of 1996. Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for combined residues of alachlor (2-chloro-2',6'-diethyl- *N* -(methoxymethyl)acetanilide) and its metabolites which can be converted to 2,6-diethylaniline
(DEA)or 2-ethyl-6-(1-hydroxyethyl)aniline (1-HEEA) upon basic hydrolysis, calculated as alachlor. EPA's assessment of exposures and risks associated with establishing the tolerances follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by alachlor as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.regulations.gov* . The referenced document is entitled FQPA Human Health Risk Assessment for Section 3 New Uses on Cotton, Sunflower, and for Inadvertent Tolerances on Various Rotational Crops (Cereal Grains and Nongrass Animal Feeds and is available in the docket established by this action, which is described under ADDRESSES , and is identified as EPA-HQ-OPP-2007-0146-003 in that docket. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern
(LOC)is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors
(UFs)are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose
(aPAD)and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. Short-, intermediate-, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure
(MOE)called for by the product of all applicable UFs is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . A summary of the toxicological endpoints for alachlor used for human risk assessment can be found at *http://www.regulations.gov* in document “FQPA Human Health Risk Assessment for Section 3 New Uses on Cotton, Sunflower, and for Inadvertent Tolerances on Various Rotational Crops (Cereal Grains and Nongrass Animal Feeds” on page 50 in docket ID number EPA-HQ-OPP-2007-0146. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to alachlor, EPA considered exposure under the petitioned-for tolerances as well as all reassessed tolerances and existing alachlor tolerances in (40 CFR 180.249). EPA assessed dietary exposures from alachlor in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for alachlor in the general population. Therefore, a quantitative acute dietary exposure is unnecessary for the general population. An effect attributable to a single dose was identified for females 13-49 in the developmental study in rats. In estimating acute dietary exposure for females 13-49, EPA used food consumption information from the U.S. Department of Agriculture
(USDA)1994-1996 or 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues. Percent crop treated
(PCT)or anticipated residues were not used. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996, or 1998 CSFII. As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance level residues. PCT or anticipated residues were not used. iii. *Cancer* . Alachlor has been classified as “likely to be carcinogenic to humans at high dose, but not at low doses”, based on treatment-related increases in nasal olfactory epithelial thyroid, and gastric tumors at higher dose levels. The Agency used the MOE approach for quantification of cancer risk. The target MOE is 100. For nasal tumors, the point of departure selected was 0.5 milligrams/kilograms/day (mg/kg/day), based on nasal tumors at 2.5 mg/kg/day in rats. For gastric tumors, a point of departure of 14 mg/kg/day was selected, based on stomach tumors seen at 42 mg/kg/day in rats. The cancer assessment was conducted using tolerance levels and 100% crop treated for all existing and proposed uses. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for alachlor in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of alachlor. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Groundwater (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of alachlor for acute exposures are estimated to be 123 parts per billion
(ppb)for surface water and 2.48 ppb for ground water. The EDWCs for chronic exposures are estimated to be 75 ppb for surface water and <2.48 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 123 ppb was used to access the contribution to drinking water. For chronic dietary risk assessment, the water concentration value of 75 ppb was used to access the contribution to drinking water. For the cancer risk assessment, the 30-year mean concentration of 64 ppb was used. 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). Alachlor is not registered for use on any sites that would result in residential exposure. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Alachlor is a member of the chloroacetanilide cumulative assessment group
(CAG)which includes alachlor, acetochlor, and butachlor. The Agency previously conducted a cumulative risk assessment for the CAG based on a common mode of action for the production of tumors of the nasal olfactory epithelium in rats. Butachlor was determined to be part of the CAG, however, there are currently no U.S. registrations for the chemical; therefore it was excluded from the cumulative risk assessment. This risk assessment is fully discussed in the document: “Cumulative Risks from Chloroacetanilide Pesticides” dated March 6, 2006 identified as document EPA-HQ-OPP-2005-0050-0061 which is available on the internet at *http://www.regulations.gov* in docket number EPA-HQ-OPP-2005-0050. Based on that cumulative risk assessment
(CRA)the Agency concluded that the cumulative risks from alachlor and acetochlor did not exceed the Agency's level of concern since cumulative MOEs were above the Agency's level of concern of 100. A revised cumulative risk assessment was performed based on the new uses for alachlor addressed in this rule and the new uses for acetochlor established in the final rule published in the **Federal Register** of May 16, 2007 (72 FR 27463) (FRL-8126-2). The revised risk assessment includes only food and water, since there are no residential uses registered for these two chemicals. Because the endpoint of interest is a cancer endpoint that arises via a mode of action that requires prolonged exposure, only a chronic dietary analysis was performed. For food exposure, tolerance levels and some average residues were used. Acetochlor residues were converted to alachlor equivalents by multiplying a factor of 0.05. The total alachlor residues were obtained by adding the alachlor residues to acetochlor (alachlor equivalents) residues for crop that have both alachlor and acetochlor tolerances. DEEM default processing factors from DEEM (Version 7.81) were used for all processed commodities that do not have individual tolerances, except for soybeans and sunflower, where processing factors from available processing studies were used. For soybeans, processing factors used in DEEM are: 0.17 for soybean oil, 0.32 for soybean protein concentrate, and 0.21 for soybean protein isolate. For sunflower, a processing factor of 0.07 was used for sunflower oil. For drinking water exposure, the 30 year mean concentration of 63.6 ppb from modeling for alachlor and degradates, plus 0.11 ppb (alachlor equivalent) from monitoring for acetochlor, totaling 64 ppb was used. The dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model (DEEM-FCID, Version 2.03) which uses food consumption data from the USDA's CSFII from 1994-1996 and 1998. It was assumed that 100% crop treated (%CT) for all commodities. The MOE for nasal tumor (the most sensitive cancer endpoint among the group) for the general U.S. population is 330 which is greater than the target MOE of 100. Therefore, the cumulative risk is below EPA's level of concern. This analysis is considered conservative dietary exposure assessment with the use of average residues for some crops, 100% crop treated, and the use of drinking water modeling data. Based on the DEEM commodity analysis, the drinking water exposure from alachlor modeling value counts for 90% of the total risk. This risk assessment is fully discussed in the document entitled “Acetochlor/Alachlor: Revised Cumulative Risk Assessment for the Chloroacetanilides to Support the Proposed New Uses on Alachlor and Acetochlor.” PP 8F05000 and 8F5025 (Alachlor), PP 6F4791, 1F6263, and 5F6918 (Acetochlor). The referenced document is available in the docket established by this action which is described under ADDRESSES and is identified as EPA-HQ-OPP-2007-0146-004 in that docket. D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional (“10X”) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . Available developmental toxicity in two species and multi-generation reproductive toxicity study in rat do not show evidence of increased susceptibility of the offspring. These studies, along with guideline toxicity studies in the adult animal, do not show evidence of neurotoxicity. Concern for increased susceptibility is low since toxicity to offspring was observed only at maternally toxic doses in the developmental toxicity studies in the rat and rabbit and in a rat multi-generation reproductive toxicity study. Clear NOELs for offspring and adults were observed in all studies. 3. *Conclusion* . EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. The toxicity database for alachlor is complete. ii. There is no indication that alachlor is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that alachlor results in increased susceptibility in *in utero* rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100%CT and tolerance-level residues. Conservative ground and surface water modeling estimates were used. These assessments will not underestimate the exposure and risks posed by alachlor. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-, intermediate-, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to alachlor will occupy 0.3% of the aPAD for the population group females (13-49) receiving the greatest exposure. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to alachlor from food and water will utilize 16% of the cPAD for the U.S. general population and 33% of the cPAD for children 1-2 years old. There are no residential uses for alachlor that result in chronic residential exposure to alachlor. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Alachlor is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Alachlor is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern. 5. *Aggregate cancer risk for U.S. population* . Using the exposure assumptions discussed in this unit for cancer risk, EPA has determined that the MOE for the U.S. population is 330 which does not exceed the EPA's level of concern (a MOE of 100). 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 alachlor residues. IV. Other Considerations A. Analytical Enforcement Methodology There are adequate analytical methods for the purposes of tolerance enforcement and data collection. An HPLC method which determines DEA- and 1-HEEA-yeilding metabolites have been validated has been validated by the Agency and is considered acceptable for enforcement purposes. The method uses HPLC with oxidative coulometric electrochemical detection (HPLC-OCED) of both DEA and 1-HEEA-producing residues, and was recommended for inclusion in PAM Vol. II as Method III, the limit of detection is 0.01 ppm for each metabolite class. Adequate enforcement methodology (HPLC-OCED) 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* . B. International Residue Limits No maximum residue limits
(MRLs)for alachlor have been established by CODEX for any agricultural commodity. V. Conclusion Therefore, the tolerance is established for combined residues of alachlor (2-chloro-2',6'-diethyl- *N* -(methoxymethyl)acetanilide) and its metabolites which can be converted to 2,6-diethylaniline
(DEA)or 2-ethyl-6-(1-hydroxyethyl)aniline (1-HEEA) upon basic hydrolysis, calculated as alachlor, as discussed in Unit II. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) 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 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act 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). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: September 13, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—AMENDED 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.249 is revised to read as follows: § 180.249 Alachlor; tolerances for residues.
(a)*General* . Tolerances are established for combined residues of alachlor (2-chloro-2',6'-diethyl- *N* -(methoxymethyl)acetanilide) and its metabolites which can be converted to 2,6-diethylaniline
(DEA)or 2-ethyl-6-(1-hydroxyethyl)aniline (1-HEEA) upon basic hydrolysis, calculated as alachlor in or on the following raw agricultural commodities. Commodity Parts per million Beans, dry 0.1 Beans, succulent lima 0.1 Cattle, fat 0.02 Cattle, meat byproducts 0.02 Cattle, meat 0.02 Corn, field, forage 2.0 Corn, field, grain 0.2 Corn, field, pop 0.2 Corn, field, stover 2.0 Corn, pop, stover 2.0 Corn, sweet (K+CWHR) 0.05 Corn, sweet, stover 2.0 Cotton, gin byproducts 0.7 Cotton, undelinted seed 0.03 Cowpea, forage 5.0 Cowpea, hay 5.0 Egg 0.02 Goat, fat 0.02 Goat, meat byproducts 0.02 Goat, meat 0.02 Hog, fat 0.02 Hog meat byproducts 0.02 Hog, meat 0.02 Horse, fat 0.02 Horse, meat byproducts 0.02 Horse, meat 0.02 Milk 0.02 Peanut 0.5 Poultry, fat 0.02 Poultry, meat byproducts 0.02 Poultry, meat 0.02 Sheep, fat 0.02 Sheep, meat byproducts 0.02 Sheep, meat 0.02 Sorghum grain, forage 2.0 Sorghum, grain, grain 0.1 Sorghum, grain, stover 1.0 Soybeans, seed 1.0 Sunflower, meal 3.4 Sunflower, seed 2.5
(b)*Section 18 emergency exemptions* . [Reserved]
(c)*Tolerances with regional registrations* . [Reserved]
(d)*Indirect or inadvertent residues* . Tolerances are established for indirect or inadvertent residues of alachlor (2-chloro-2',6'-diethyl- *N* -(methoxymethyl)acetanilide) and its metabolites which can be converted to 2,6-diethylaniline
(DEA)or 2-ethyl-6-(1-hydroxyethyl)aniline (1-HEEA) upon basic hydrolysis, calculated as alachlor, in or on the following raw agricultural commodities when present therein as a result of the application of alachlor to the growing crops in paragraph
(a)of this section: Commodity Parts per million Animal feed, nongrass, group 18, forage 1.4 Animal feed, nongrass, group 18, hay 1.2 Grain, cereal, forage, and straw, group 16 except corn, sorghum, rice, straw 0.8 Grain, cereal, forage, fodder and straw, group 16 except corn, sorghum, rice, forage 0.6 Grain, cereal, forage, fodder, and straw, group 16 except for corn, sorghum, rice, hay 0.8 Grain, cereal, group 15 except corn, sorghum, rice 0.05 [FR Doc. E7-18967 Filed 9-25-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0145; FRL-8148-1] Tepraloxydim; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a tolerance for residues of tepraloxydim in or on imported flax, seed; lentil, seed; and pea, dry seed. BASF requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective September 26, 2007. Objections and requests for hearings must be received on or before November 26, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2007-0145. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-5697; e-mail address: *tompkins.jim@epa.gov* . SUPPLEMENTARY INFORMATION: 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), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather 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 . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, 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-2007-0145 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before November 26, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2007-0145, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. II. Petition for Tolerance In the **Federal Register** of May 9, 2007 (72 FR 26372) (FRL-8121-5), 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 6E7046) by BASF, 26 Davis Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.573 be amended by establishing a tolerance for residues of the herbicide tepraloxdydim (2-[1-[[[(2E)-3-chloro-2-propenyl]oxy]imino]propyl]-3-hydroxy-5-(tetrahydro-2H-pyran-4-yl)-2-cyclohexen-1-one) and its metabolites convertible to GP (3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid) and OH-GP (3-hydroxy-3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid), calculated as tepraloxydim, in or on imported flax, seed; lentil, seed; and pea, dry, seed at 0.10 parts per million (ppm). That notice referenced a summary of the petition prepared by BASF, the registrant, which is available to the public in the docket, *http://www.regulations.gov* . There were no comments received in response to the notice of filing. III. Aggregate Risk Assessment and Determination of Safety 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. . . .” These provisions were added to FFDCA by the Food Quality Protection Act
(FQPA)of 1996. Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerance for residues of tepraloxydim on imported flax, seed; lentil, seed; and pea, dry, seed at 0.10 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by tepraloxydim as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.regulations.gov* . The referenced document is available in the docket established by this action, which is described under ADDRESSES , and is identified as document 3 (pages 44-47) in docket ID number EPA-HQ-OPP-2007-0145 in that docket. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern
(LOC)is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors
(UFs)are used in conjunction with the Point of Departure
(POD)to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose
(aPAD)and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by all applicable UFs. Short-, intermediate-, and long-term risks are evaluated by comparing aggregate exposure to the POD to ensure that the LOC called for by the product of all applicable UFs is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . A summary of the toxicological endpoints for tepraloxydim used for human risk assessment can be found at *http://www.regulations.gov* in document 3 (pages 22-23) in docket ID number EPA-HQ-OPP-2007-0145. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to tepraloxydim, EPA considered exposure under the petitioned-for tolerances as well as all existing tepraloxydim tolerances in (40 CFR 180.573). EPA assessed dietary exposures from tepraloxydim in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. In estimating acute dietary exposure, EPA used food consumption information from the U.S. Department of Agriculture
(USDA)1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues. 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 all foods for which there are tolerances were treated and contain tolerance-level residues. iii. *Cancer* . Tepraloxydim is classified as “Data are inadequate for an assessment of human carcinogenic potential”, because there was some evidence of liver tumors in female rats at the high dose in the carcinogenicity phase of the study, but not in the chronic phase of the study. Female mice developed liver tumors at an excessively toxic dose. Male mice had non-neoplastic liver changes similar to or exceeding those seen in female mice at the same dose, though there was no increase in liver tumor incidences. Tepraloxydim was not mutagenic in a battery of assays. Considering all of this evidence, tepraloxydim is not expected to pose a cancer risk for humans, and a quantitative cancer risk assessment was not conducted. iv. *Anticipated residue and percent crop treated
(PCT)information* . EPA did not use anticipated residues or PCT information in the dietary assessment for tepraloxydim. The acute and chronic dietary exposure analyses were based on tolerance level residues and 100 PCT assumptions. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for tepraloxydim in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling, taking into account data on the environmental fate characteristics of tepraloxydim. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Groundwater (SCI-GROW) models, the estimated environmental concentrations
(EECs)of tepraloxydim for acute exposures are estimated to be 1.4 parts per billion
(ppb)for surface water and 0.002 ppb for ground water. The EECs for chronic exposures are estimated to be 0.7 ppb for surface water and 0.002 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 1.4 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 0.7 ppb was used to assess the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Tepraloxydim is not registered for use on any sites that would result in residential exposure. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to and any other substances and tepraloxydim does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that tepraloxydim has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional (“10X”) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . There were qualitative and quantitative prenatal susceptibility in the rat developmental toxicity study. The developmental findings with a NOAEL of 40 milligrams/kilograms/day (mg/kg/day) were well characterized and included increased developmental sensitivity in the form of reduced fetal body weights, retarded ossification indicative of delayed maturation and the presence of hydroureter at 120 mg/kg/day (developmental LOAEL). Rare malformations (dilation of both heart ventricles and filiform tail) were also detected at the high dose of 360 mg/kg/day. The maternal toxicity NOAEL/LOAEL of 120/360 mg/kg/day was based on reduced body weight gain and food consumption. There was no evidence of increased susceptibility following prenatal exposure to rabbits, nor was there evidence of increased susceptibility following prenatal and/or postnatal exposure to rats (in the rat reproduction and fertility effects study). The degree of concern is low for the increased susceptibility seen the developmental study in rats (prenatal exposure) since a clear NOAEL/LOAEL was established for developmental toxicity, and since the endpoints of concern were used for the most sensitive population of concern (Females 13-49). There is no uncertainty for prenatal and/or postnatal toxicity. 3. *Conclusion* . The 10X FQPA safety factor was retained for assessing the acute dietary risk to the general population (including infants and children), due to the lack of a NOAEL in the acute neurotoxicity study. The 10X FQPA safety factor was reduced to 1X for assessing the acute dietary risk to females (13-49 years of age) and for assessing the chronic dietary risk to all populations based on the following conclusions. i. The toxicity database for tepraloxydim is complete. ii. While there are indications that tepraloxydim is neurotoxic at doses far higher than those currently being used for the acute and chronic dietary risk assessments, the two generation reproduction study showed no clinical signs indicative of neurotoxicity in the parental animals or offspring, nor was there evidence for increased susceptibility. The Agency concluded there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There are no residual concerns regarding increased sensitivity in the young. There were no qualitative or quantitative prenatal or postnatal susceptibility issues in the developmental toxicity study in rabbits and 2-generation reproduction toxicity study in rats. Although increased sensitivity was seen in the developmental rat study, the degree of concern is low as to this finding because a clear NOAEL/LOAEL was established for developmental toxicity, and the endpoints of concern were used for assessing risk to the most sensitive population of concern (Females 13-49). iv. The dietary food exposure assessment was performed based on 100%CT and tolerance-level residues. Conservative ground water and surface water modeling estimates were used. The drinking water assessment utilized values generated by models and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations. These assessments will not underestimate the exposure and risks posed by tepraloxydim. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-, intermediate-, and long-term risks are evaluated by comparing the LOC to ensure that the Margin of exposure called for by the product of all applicable UFs is not exceeded. 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to tepraloxydim will occupy 2% of the aPAD for the population group (children 1-2 years old) receiving the greatest exposure. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to tepraloxydim from food and water will utilize 10% of the cPAD for the population group (children 1-2 years old) receiving the greatest exposure. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Tepraloxydim is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which does not exceed the Agency's level of concern. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Tepraloxydim is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern. 5. *Aggregate cancer risk for U.S. population* . Tepraloxydim is not expected to pose a cancer risk for humans. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to tepraloxydim residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology is available to enforce the tolerance expression. The analytical method involves extraction, concentration, precipitation, centrifugation/filtration, oxidation, partition, and clean-up. Samples are then analyzed by GC-MS (selected ion monitoring). The LOQ is 0.05 ppm for each analyte. 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* . B. International Residue Limits No Codex maximum residue limits
(MRLs)have been established for residues of tepraloxydim on any crops at this time. V. Conclusion Therefore, the tolerance is established for residues tepraloxdydim (2-[1-[[[(2E)-3-chloro-2-propenyl]oxy]imino]propyl]-3-hydroxy-5-(tetrahydro-2H-pyran-4-yl)-2-cyclohexen-1-one) and its metabolites convertible to GP (3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid) and OH-GP (3-hydroxy-3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid), calculated as tepraloxydim, in or on flax, seed; lentil, seed; and pea, dry, seed at 0.10 parts per million (ppm). VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) 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 6, 2000) do not apply to this rule. In addition, this rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act 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). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: September 13, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.573 is amended by alphabetically adding the following commodities to the table in paragraph (a)(1) to read as follows: § 180.573 Tepraloxydim; tolerances for residues.
(a)*General* .
(1)* * * Commodity Parts per million * * * * * Flax, seed 0.10 Lentil, seed 0.10 Pea, dry, seed 0.10 * * * * * [FR Doc. E7-18850 Filed 9-25-07; 8:45 am] BILLING CODE 6560-50-S DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 64 [Docket No. FEMA-7991] Suspension of Community Eligibility AGENCY: Federal Emergency Management Agency, DHS. ACTION: Final rule. SUMMARY: This rule identifies communities, where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP), that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency
(FEMA)receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the **Federal Register** on a subsequent date. DATES: *Effective Dates:* The effective date of each community's scheduled suspension is the third date (“Susp.”) listed in the third column of the following tables. ADDRESSES: If you want to determine whether a particular community was suspended on the suspension date, contact the appropriate FEMA Regional Office. FOR FURTHER INFORMATION CONTACT: David Stearrett, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472,
(202)646-2953. SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase flood insurance which is generally not otherwise available. In return, communities agree to adopt and administer local floodplain management aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage as authorized under the NFIP, 42 U.S.C. 4001 *et seq.* ; unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. However, some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue their eligibility for the sale of insurance. A notice withdrawing the suspension of the communities will be published in the **Federal Register** . In addition, FEMA has identified the Special Flood Hazard Areas (SFHAs) in these communities by publishing a Flood Insurance Rate Map (FIRM). The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may legally be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year, on FEMA's initial flood insurance map of the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment under 5 U.S.C. 553(b) are impracticable and unnecessary because communities listed in this final rule have been adequately notified. Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days. *National Environmental Policy Act.* This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared. *Regulatory Flexibility Act.* The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place. *Regulatory Classification.* This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735. *Executive Order 13132, Federalism.* This rule involves no policies that have federalism implications under Executive Order 13132. *Executive Order 12988, Civil Justice Reform.* This rule meets the applicable standards of Executive Order 12988. *Paperwork Reduction Act.* This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 *et seq.* List of Subjects in 44 CFR Part 64 Flood insurance, Floodplains. Accordingly, 44 CFR part 64 is amended as follows: PART 64—[AMENDED] 1. The authority citation for part 64 continues to read as follows: Authority: 42 U.S.C. 4001 *et seq.* ; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp.; p. 376. § 64.6 [Amended] 2. The tables published under the authority of § 64.6 are amended as follows: State and location Community No. Effective date authorization/ cancellation of sale of flood insurance in community Current effective map date Date certain Federal assist- ance no longer available in SFHAs Region III Maryland: Brunswick, City of, Frederick County 240028 August 16, 1974, Emerg; January 7, 1977, Reg; September 19, 2007, Susp Sept. 19, 2007 Sept. 19, 2007. Emmitsburg, Town of, Frederick County 240029 May 6, 1975, Emerg; September 17, 1980, Reg; September 19, 2007, Susp ......do* Do. Frederick, City of, Frederick County 240030 May 24, 1973, Emerg; June 15, 1978, Reg; September 19, 2007, Susp ......do Do. Frederick County, Unincorporated Areas 240027 May 24, 1973, Emerg; June 1, 1978, Reg; September 19, 2007, Susp ......do Do. Middletown, Town of, Frederick County 240162 December 21, 1978, Emerg; October 23, 1981, Reg; September 19, 2007, Susp ......do Do. Thurmont, Town of, Frederick County 240031 November 15, 1974, Emerg; September 28, 1979, Reg; September 19, 2007, Susp ......do Do. Walkersville, Town of, Frederick County 240032 June 12, 1974, Emerg; September 30, 1980, Reg; September 19, 2007, Susp ......do Do. Woodsboro, Town of, Frederick County 240033 February 26, 1975, Emerg; December 15, 1978, Reg; September 19, 2007, Susp ......do Do. Virginia: Amherst, Town of, Amherst County 510193 February 7, 1974, Emerg; November 2, 1977, Reg; September 19, 2007, Susp ......do Do. Amherst County, Unincorporated Areas 510010 March 1, 1974, Emerg; July 17, 1978, Reg; September 19, 2007, Susp ......do Do. Fredericksburg, City of, Independent City 510065 November 5, 1973, Emerg; July 2, 1979, Reg; September 19, 2007, Susp ......do Do. Region IV Georgia: Temple, City of, Carroll County 130288 December 22, 1986, Emerg; September 18, 1987, Reg; September 19, 2007, Susp ......do Do. North Carolina: Creswell, Town of, Washington County 370443 January 24, 1975, Emerg; August 19, 1985, Reg; September 19, 2007, Susp ......do Do. Hamilton, Town of, Martin County 370334 March 26, 1979, Emerg; January 1, 1987, Reg; September 19, 2007, Susp ......do Do. Martin County, Unincorporated Areas 370155 December 18, 1975, Emerg; July 16, 1991, Reg; September 19, 2007, Susp ......do Do. Plymouth, Town of, Washington County 370249 April 11, 1974, Emerg; August 19, 1985, Reg; September 19, 2007, Susp ......do Do. Robersonville, Town of, Martin County 370156 July 7, 1975, Emerg; July 1, 1987, Reg; September 19, 2007, Susp ......do Do. Roper, Town of, Washington County 370421 June 9, 1978, Emerg; August 5, 1985, Reg; September 19, 2007, Susp ......do Do. Washington County, Unincorporated Areas 370247 January 24, 1975, Emerg; August 19, 1985, Reg; September 19, 2007, Susp ......do Do. Williamston, Town of, Martin County 370157 October 2, 1974, Emerg; August 19, 1987, Reg; September 19, 2007, Susp ......do Do. Tennessee: Petersburg, City of, Lincoln County 470106 March 24, 1975, Emerg; September 29, 1986, Reg; September 19, 2007, Susp ......do Do. Region V Michigan: Burlington, Township of, Lapeer County 261010 December 22, 1997, Emerg, Reg; September 19, 2007, Susp ......do Do. Deerfield, Township of, Lapeer County 260434 August 7, 1995, Emerg, Reg; September 19, 2007, Susp ......do Do. Elba, Township of, Lapeer County 260776 May 6, 1997, Emerg, Reg; September 19, 2007, Susp ......do Do. Goodland, Township of, Lapeer County 260988 May 6, 1997, Emerg, Reg; September 19, 2007, Susp ......do Do. Hadley, Township of, Lapeer County 261045 July 12, 2001, Emerg, Reg; September 19, 2007, Susp ......do Do. Lapeer, City of, Lapeer County 260112 November 25, 1974, Emerg; June 15, 1979, Reg; September 19, 2007, Susp ......do Do. Lapeer, Township of, Lapeer County 260435 April 26, 1982, Emerg; February 16, 1990, Reg; September 19, 2007, Susp ......do Do. Mayfield, Township of, Lapeer County 260436 March 10, 1982, Emerg; February 16, 1990, Reg; September 19, 2007, Susp ......do Do. North Branch, Village of, Lapeer County 260338 April 2, 1998, Emerg, Reg; September 19, 2007, Susp ......do Do. Rich, Township of, Lapeer County 261023 August 13, 1998, Emerg, Reg; September 19, 2007, Susp ......do Do. Ohio: Brice, Village of, Franklin County 261023 August 13, 1998, Emerg, Reg; September 19, 2007, Susp ......do Do. Columbus, City of, Delaware, Fairfield and Franklin Counties 390170 May 21, 1971, Emerg; July 5, 1983, Reg; September 19, 2007, Susp ......do Do. Fairfield County, Unincorporated Areas 390158 March 21, 1977, Emerg; April 17, 1989, Reg; September 19, 2007, Susp ......do Do. Franklin County, Unincorporated Areas 390167 April 19, 1973, Emerg; July 5, 1983, Reg; September 19, 2007, Susp ......do Do. Region VIII Colorado: Canon City, City of, Fremont County 080068 May 28, 1974, Emerg; November 3, 1982, Reg; September 19, 2007, Susp ......do Do. Fremont County, Unincorporated Areas 080067 June 25, 1975, Emerg; September 29, 1989, Reg; September 19, 2007, Susp ......do Do. Montana: Whitehall, City of, Jefferson County 300120 May 7, 1975, Emerg; June 4, 1987, Reg; September 19, 2007, Susp ......do Do. * -do- =Ditto. Code for reading third column: Emerg.—Emergency; Reg.—Regular; Susp.—Suspension. Dated: September 14, 2007. Michael K. Buckley, Deputy Assistant Administrator, Mitigation, Department of Homeland Security, Federal Emergency Management Agency. [FR Doc. E7-18953 Filed 9-25-07; 8:45 am] BILLING CODE 9110-12-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 64 [Docket No. FEMA-7993] Suspension of Community Eligibility AGENCY: Federal Emergency Management Agency, DHS. ACTION: Final rule. SUMMARY: This rule identifies communities, where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP), that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency
(FEMA)receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the **Federal Register** on a subsequent date. DATES: *Effective Dates:* The effective date of each community's scheduled suspension is the third date (“Susp.”) listed in the third column of the following tables. ADDRESSES: If you want to determine whether a particular community was suspended on the suspension date, contact the appropriate FEMA Regional Office. FOR FURTHER INFORMATION CONTACT: David Stearrett, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472,
(202)646-2953. SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase flood insurance which is generally not otherwise available. In return, communities agree to adopt and administer local floodplain management aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage as authorized under the NFIP, 42 U.S.C. 4001 *et seq.* ; unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. However, some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue their eligibility for the sale of insurance. A notice withdrawing the suspension of the communities will be published in the **Federal Register** . In addition, FEMA has identified the Special Flood Hazard Areas (SFHAs) in these communities by publishing a Flood Insurance Rate Map (FIRM). The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may legally be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year, on FEMA's initial flood insurance map of the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment under 5 U.S.C. 553(b) are impracticable and unnecessary because communities listed in this final rule have been adequately notified. Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days. *National Environmental Policy Act.* This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared. *Regulatory Flexibility Act.* The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place. *Regulatory Classification.* This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735. *Executive Order 13132, Federalism.* This rule involves no policies that have federalism implications under Executive Order 13132. *Executive Order 12988, Civil Justice Reform.* This rule meets the applicable standards of Executive Order 12988. *Paperwork Reduction Act.* This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 *et seq.* List of Subjects in 44 CFR Part 64 Flood insurance, Floodplains. Accordingly, 44 CFR part 64 is amended as follows: PART 64—[AMENDED] 1. The authority citation for part 64 continues to read as follows: Authority: 42 U.S.C. 4001 *et seq.* ; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp.; p. 376. § 64.6 [Amended] 2. The tables published under the authority of § 64.6 are amended as follows: State and location Community No. Effective date authorization/cancellation of sale of flood insurance in community Current effective map date Date certain Federal assistance no longer available in SFHAs Region I Vermont: Andover, Town of, Windsor County 500291 April 30, 1975, Emerg; August 5, 1985, Reg; September 28, 2007, Susp Sept. 28, 2007 Sept. 28, 2007. Barnard, Town of, Windsor County 500292 June 16, 1975, Emerg; September 18, 1985, Reg; September 28, 2007, Susp ......do* Do. Bethel, Town of, Windsor County 500143 November 1, 1974, Emerg; August 5, 1991, Reg; September 28, 2007, Susp ......do Do. Brattleboro, Town of, Windham County 500126 October 23, 1973, Emerg; December 4, 1985, Reg; September 28, 2007, Susp ......do Do. Cavendish, Town of, Windsor County 500145 August 6, 1974, Emerg; October 15, 1981, Reg; September 28, 2007, Susp ......do Do. Chester, Town of, Windsor County 500146 July 3, 1975, Emerg; March 4, 1980, Reg; September 28, 2007, Susp ......do Do. Dover, Town of, Windham County 500127 July 21, 1976, Emerg; July 1, 1991, Reg; September 28, 2007, Susp ......do Do. Dummerston, Town of, Windham County 500128 July 23, 1975, Emerg; June 17, 1991, Reg; September 28, 2007, Susp ......do Do. Guilford, Town of, Windham County 500130 September 4, 1975, Emerg; June 3, 1986, Reg; September 28, 2007, Susp ......do Do. Hartford, Town of, Windsor County 500148 February 11, 1972, Emerg; July 2, 1979, Reg; September 28, 2007, Susp ......do Do. Hartland, Town of, Windsor County 500149 June 3, 1993, Emerg; June 3, 1993, Reg; September 28, 2007, Susp ......do Do. Jamaica, Town of, Windham County 500131 August 7, 1975, Emerg; May 5, 1981, Reg; September 28, 2007, Susp ......do Do. Londonderry, Town of, Windham County 500132 July 24, 1975, Emerg; April 1, 1992, Reg; September 28, 2007, Susp ......do Do. Ludlow, Town of, Windsor County 500150 October 11, 1974, Emerg; September 1, 1978, Reg; September 28, 2007, Susp ......do Do. Ludlow, Village of, Windsor County 500294 October 11, 1974, Emerg; September 1, 1978, Reg; September 28, 2007, Susp ......do Do. Norwich, Town of, Windsor County 500295 June 7, 1974, Emerg; June 15, 1988, Reg; September 28, 2007, Susp ......do Do. Plymouth, Town of, Windsor County 500151 November 21, 1975, Emerg; June 19, 1989, Reg; September 28, 2007, Susp ......do Do. Pomfret, Town of, Windsor County 500297 October 17, 1975, Emerg; September 18, 1985, Reg; September 28, 2007, Susp ......do Do. Putney, Town of, Windham County 500134 June 24, 1975, Emerg; September 18, 1985, Reg; September 28, 2007, Susp ......do Do. Reading, Town of, Windsor County 500152 May 8, 1975, Emerg; May 4, 1989, Reg; September 28, 2007, Susp ......do Do. Rochester, Town of, Windsor County 500299 July 25, 1975, Emerg; August 5, 1991, Reg; September 28, 2007, Susp ......do Do. Royalton, Town of, Windsor County 500153 July 24, 1975, Emerg; January 16, 1981, Reg; September 28, 2007, Susp ......do Do. Sharon, Town of, Windsor County 500300 June 16, 1995, Emerg, Reg; September 28, 2007, Susp ......do Do. Springfield, Town of, Windsor County 500154 June 17, 1975, Emerg; December 4, 1979, Reg; September 28, 2007, Susp ......do Do. Stockbridge, Town of, Windsor County 500155 July 8, 1975, Emerg; September 4, 1986, Reg; September 28, 2007, Susp ......do Do. Townshend, Town of, Windham County 500136 July 25, 1975, Emerg; September 18, 1985, Reg; September 28, 2007, Susp ......do Do. Vernon, Town of, Windham County 500137 June 25, 1975, Emerg; September 27, 1991, Reg; September 28, 2007, Susp ......do Do. Wardsboro, Town of, Windham County 500138 December 23, 1975, Emerg; July 16, 1980, Reg; September 28, 2007, Susp ......do Do. Weathersfield, Town of, Windsor County 500156 September 22, 1975, Emerg; September 18, 1985, Reg; September 28, 2007, Susp ......do Do. West Windsor, Town of, Windsor County 500301 March 11, 1976, Emerg; June 17, 1991, Reg; September 28, 2007, Susp ......do Do. Westminster, Town of, Windham County 500139 July 25, 1975, Emerg; January 3, 1985, Reg; September 28, 2007, Susp ......do Do. Weston, Town of, Windsor County 500157 July 25, 1974, Emerg; April 1, 1992, Reg; September 28, 2007, Susp ......do Do. Whitingham, Town of, Windham County 500141 September 10, 1975, Emerg; September 18, 1985, Reg; September 28, 2007, Susp ......do Do. Wilmington, Town of, Windham County 500142 May 25, 1973, Emerg; May 1, 1978, Reg; September 28, 2007, Susp ......do Do. Windsor, Town of, Windsor County 500159 August 16, 1974, Emerg; September 28, 1979, Reg; September 28, 2007, Susp ......do Do. Woodstock, Town of, Windsor County 500160 April 30, 1974, Emerg; December 15, 1978, Reg; September 28, 2007, Susp ......do Do. Woodstock, Village of, Windsor County 500161 March 27, 1974, Emerg; February 15, 1979, Reg; September 28, 2007, Susp ......do Do. Region II New Jersey: Audubon, Borough of, Camden County 340121 July 3, 1975, Emerg; October 13, 1978, Reg; September 28, 2007, Susp ......do Do. Bedminster, Township of, Somerset County 340427 July 26, 1974, Emerg; January 5, 1984, Reg; September 28, 2007, Susp ......do Do. Bellmawr, Borough of, Camden County 340124 August 1, 1974, Emerg; February 15, 1980, Reg; September 28, 2007, Susp ......do Do. Berlin, Borough of, Camden County 340125 June 10, 1975, Emerg; May 13, 1977, Reg; September 28, 2007, Susp ......do Do. Berlin, Township of, Camden County 340126 March 25, 1975, Emerg; February 24, 1978, Reg; September 28, 2007, Susp ......do Do. Bernards, Township of, Somerset County 340428 February 4, 1972, Emerg; September 1, 1978, Reg; September 28, 2007, Susp ......do Do. Bernardsville, Borough of, Somerset County 340429 December 17, 1971, Emerg; March 1, 1978, Reg; September 28, 2007, Susp ......do Do. Bloomingdale, Borough of, Passaic County 345284 October 2, 1970, Emerg; March 10, 1972, Reg; September 28, 2007, Susp ......do Do. Bound Brook, Borough of, Somerset County 340430 January 14, 1972, Emerg; August 15, 1983, Reg; September 28, 2007, Susp ......do Do. Branchburg, Township of, Somerset County 340431 June 2, 1972, Emerg; June 1, 1978, Reg; September 28, 2007, Susp ......do Do. Bridgewater, Township of, Somerset County 340432 November 26, 1971, Emerg; December 1, 1978, Reg; September 28, 2007, Susp ......do Do. Brooklawn, Borough of, Camden County 340127 July 16, 1975, Emerg; September 14, 1979, Reg; September 28, 2007, Susp ......do Do. Camden, City of, Camden County 340128 May 16, 1975, Emerg; December 1, 1981, Reg; September 28, 2007, Susp ......do Do. Cherry Hill, Township of, Camden County 340129 January 14, 1972, Emerg; August 15, 1978, Reg; September 28, 2007, Susp ......do Do. Clementon, Borough of, Camden County 340130 January 30, 1975, Emerg; October 21, 1983, Reg; September 28, 2007, Susp ......do Do. Clifton, City of, Passaic County 340398 February 19, 1975, Emerg; June 15, 1982, Reg; September 28, 2007, Susp ......do Do. Collingswood, Borough of, Camden County 340131 April 9, 1973, Emerg; July 17, 1978, Reg; September 28, 2007, Susp ......do Do. Far Hills, Borough of, Somerset County 340433 January 7, 1972, Emerg; July 3, 1978, Reg; September 28, 2007, Susp ......do Do. Franklin, Township of, Somerset County 340434 April 6, 1973, Emerg; May 15, 1980, Reg; September 28, 2007, Susp ......do Do. Gibbsboro, Borough of, Camden County 340545 July 23, 1975, Emerg; October 15, 1981, Reg; September 28, 2007, Susp ......do Do. Gloucester, City of, Camden County 340132 December 19, 1974, Emerg; September 14, 1979, Reg; September 28, 2007, Susp ......do Do. Gloucester, Township of, Camden County 340133 July 24, 1975, Emerg; December 1, 1982, Reg; September 28, 2007, Susp ......do Do. Greenbrook, Township of, Somerset County 340435 February 25, 1972, Emerg; March 15, 1977, Reg; September 28, 2007, Susp ......do Do. Haddon, Township of, Camden County 340134 April 12, 1974, Emerg; March 1, 1982, Reg; September 28, 2007, Susp ......do Do. Haddon Heights, Borough of, Camden County 340136 May 27, 1975, Emerg; August 26, 1977, Reg; September 28, 2007, Susp ......do Do. Haddonfield, Borough of, Camden County 340501 July 14, 1972, Emerg; April 15, 1977, Reg; September 28, 2007, Susp ......do Do. Haledon, Borough of, Passaic County 340399 May 13, 1975, Emerg; March 16, 1981, Reg; September 28, 2007, Susp ......do Do. Hawthorne, Borough of, Passaic County 340400 June 28, 1973, Emerg; September 17, 1980, Reg; September 28, 2007, Susp ......do Do. Hillsborough, Township of, Somerset County 340436 June 18, 1974, Emerg; March 2, 1981, Reg; September 28, 2007, Susp ......do Do. Laurel Springs, Borough of, Camden County 340547 March 23, 1976, Emerg; May 13, 1977, Reg; September 28, 2007, Susp ......do Do. Lawnside, Borough of, Camden County 340502 January 15, 1974, Emerg; September 1, 1978, Reg; September 28, 2007, Susp ......do Do. Lindenwold, Borough of, Camden County 340137 January 12, 1976, Emerg; September 17, 1980, Reg; September 28, 2007, Susp ......do Do. Little Falls, Township of, Passaic County 340401 July 6, 1973, Emerg; August 17, 1981, Reg; September 28, 2007, Susp ......do Do. Magnolia, Borough of, Camden County 340138 June 18, 1974, Emerg; November 24, 1978, Reg; September 28, 2007, Susp ......do Do. Manville, Borough of, Somerset County 340437 December 15, 1972, Emerg; February 15, 1978, Reg; September 28, 2007, Susp ......do Do. Millstone, Borough of, Somerset County 340438 October 29, 1973, Emerg; April 3, 1978, Reg; September 28, 2007, Susp ......do Do. Montgomery, Township of, Somerset County 340439 August 20, 1974, Emerg; April 1, 1981, Reg; September 28, 2007, Susp ......do Do. Mount Ephraim, Borough of, Camden County 340140 April 15, 1975, Emerg; September 1, 1978, Reg; September 28, 2007, Susp ......do Do. North Haledon, Borough of, Passaic County 340402 January 29, 1975, Emerg; July 2, 1981, Reg; September 28, 2007, Susp ......do Do. North Plainfield, City of, Somerset County 345307 November 6, 1970, Emerg; August 20, 1971, Reg; September 28, 2007, Susp ......do Do. Oaklyn, Borough of, Camden County 340141 September 16, 1975, Emerg; November 3, 1978, Reg; September 28, 2007, Susp ......do Do. Passaic, City of, Passaic County 340403 April 9, 1973, Emerg; September 28, 1979, Reg; September 28, 2007, Susp ......do Do. Paterson, City of, Passaic County 340404 November 12, 1971, Emerg; February 16, 1977, Reg; September 28, 2007, Susp ......do Do. Peapack and Gladstone, Borough of, Somerset County 340441 January 28, 1972, Emerg; December 15, 1977, Reg; September 28, 2007, Susp ......do Do. Pennsauken, Township of, Camden County 340142 January 28, 1972, Emerg; April 15, 1977, Reg; September 28, 2007, Susp ......do Do. Pine Hill, Borough of, Camden County 340143 March 11, 1975, Emerg; February 24, 1978, Reg; September 28, 2007, Susp ......do Do. Pompton Lakes, Borough of, Passaic County 345528 June 5, 1970, Emerg; September 4, 1970, Reg; September 28, 2007, Susp ......do Do. Prospect Park, Borough of, Passaic County 340406 August 7, 1975, Emerg; April 3, 1978, Reg; September 28, 2007, Susp ......do Do. Raritan, Borough of, Somerset County 340442 December 10, 1974, Emerg; December 15, 1981, Reg; September 28, 2007, Susp ......do Do. Ringwood, Borough of, Passaic County 340407 June 18, 1975, Emerg; February 3, 1982, Reg; September 28, 2007, Susp ......do Do. Rocky Hill, Borough of, Somerset County 340443 July 15, 1975, Emerg; December 16, 1980, Reg; September 28, 2007, Susp ......do Do. Runnemede, Borough of, Camden County 340144 August 7, 1973, Emerg; January 2, 1980, Reg; September 28, 2007, Susp ......do Do. Somerdale, Borough of, Camden County 340145 December 17, 1971, Emerg; February 1, 1979, Reg; September 28, 2007, Susp ......do Do. Somerville, Borough of, Camden County 340444 May 22, 1975, Emerg; January 6, 1983, Reg; September 28, 2007, Susp ......do Do. South Bound Brook, Borough of, Camden County 340445 February 12, 1975, Emerg; September 30, 1982, Reg; September 28, 2007, Susp ......do Do. Stratford, Borough of, Camden County 340146 March 21, 1975, Emerg; September 17, 1980, Reg; September 28, 2007, Susp ......do Do. Totowa, Borough of, Passaic County 340408 May 23, 1975, Emerg; August , 1985, Reg; September 28, 2007, Susp ......do Do. Voorhees, Township of, Camden County 340538 August 2, 1974, Emerg; September 1, 1978, Reg; September 28, 2007, Susp ......do Do. Wanaque, Borough of, Passaic County 340409 August 12, 1974, Emerg; January 16, 1981, Reg; September 28, 2007, Susp ......do Do. Warren, Township of, Somerset County 340446 February 4, 1972, Emerg; January 5, 1978, Reg; September 28, 2007, Susp ......do Do. Watchung, Borough of, Somerset County 340447 September 17, 1973, Emerg; December 4, 1979, Reg; September 28, 2007, Susp ......do Do. Waterford, Township of, Camden County 340147 July 15, 1975, Emerg; April 29, 1983, Reg; September 28, 2007, Susp ......do Do. Wayne, Township of, Passaic County 345327 July 10, 1970, Emerg; February 16, 1972, Reg; September 28, 2007, Susp ......do Do. West Milford, Township of, Passaic County 340411 April 28, 1975, Emerg; January 16, 1981, Reg; September 28, 2007, Susp ......do Do. West Paterson, Borough of, Passaic County 340412 June 25, 1975, Emerg; December 15, 1981, Reg; September 28, 2007, Susp ......do Do. Winslow, Township of, Camden County 340148 July 31, 1975, Emerg; January 20, 1982, Reg; September 28, 2007, Susp ......do Do. Woodlynne, Borough of, Camden County 340149 June 24, 1975, Emerg; December 1, 1981, Reg; September 28, 2007, Susp ......do Do. New York: Ardsley, Village of, Westchester County 360902 December 30, 1971, Emerg; September 29, 1978, Reg; September 28, 2007, Susp ......do Do. Beekmantown, Town of, Clinton County 360166 December 15, 1976, Emerg; May 4, 1987, Reg; September 28, 2007, Susp ......do Do. Black Brook, Town of, Clinton County 361309 January 19, 1976, Emerg; August 15, 1983, Reg; September 28, 2007, Susp ......do Do. Briarcliff Manor, Village of, Westchester County 360904 May 23, 1973, Emerg; February 1, 1978, Reg; September 28, 2007, Susp ......do Do. Bronxville, Village of, Westchester County 360905 March 16, 1973, Emerg; March 1, 1979, Reg; September 28, 2007, Susp ......do Do. Buchanan, Village of, Westchester County 361534 June 28, 1977, Emerg; July 27, 1979, Reg; September 28, 2007, Susp ......do Do. Dobbs Ferry, Village of, Westchester County 360908 August 10, 1976, Emerg; April 16, 1979, Reg; September 28, 2007, Susp ......do Do. Ellenburg, Town of, Clinton County 361382 May 23, 1984, Emerg; March 4, 1986, Reg; September 28, 2007, Susp ......do Do. Elmsford, Village of, Westchester County 360910 June 27, 1975, Emerg; June 15, 1979, Reg; September 28, 2007, Susp ......do Do. Greenburgh, Town of, Westchester County 360911 February 23, 1973, Emerg; August 15, 1980, Reg; September 28, 2007, Susp ......do Do. Harrison, Town of, Westchester County 360912 February 2, 1973, Emerg; March 15, 1982, Reg; September 28, 2007, Susp ......do Do. Hastings-on-Hudson, Village of, Westchester County 360913 January 23, 1975, Emerg; April 2, 1979, Reg; September 28, 2007, Susp ......do Do. Irvington, Village of, Westchester County 360914 June 28, 1974, Emerg; March 15, 1979, Reg; September 28, 2007, Susp ......do Do. Keeseville, Village of, Clinton and Essex County 360266 May 29, 1980, Emerg; June 5, 1985, Reg; September 28, 2007, Susp ......do Do. Larchmont, Village of, Westchester County 360915 February 4, 1972, Emerg; September 1, 1977, Reg; September 28, 2007, Susp ......do Do. Lewisboro, Town of, Westchester County 361227 September 12, 1975, Emerg; March 9, 1984, Reg; September 28, 2007, Susp ......do Do. Mount Kisco, Village of, Westchester County 360918 March 8, 1976, Emerg; September 18, 1986, Reg; September 28, 2007, Susp ......do Do. Mount Vernon, City of, Westchester County 360920 April 22, 1975, Emerg; October 17, 1978, Reg; September 28, 2007, Susp ......do Do. New Rochelle, City of, Westchester County 360922 April 27, 1973, Emerg; June 18, 1980, Reg; September 28, 2007, Susp ......do Do. North Castle, Town of, Westchester County 360923 June 12, 1975, Emerg; December 2, 1983, Reg; September 28, 2007, Susp ......do Do. Ossining, Village of, Westchester County 361021 October 18, 1974, Emerg; July 5, 1982, Reg; September 28, 2007, Susp ......do Do. Peekskill, City of, Westchester County 360924 July 7, 1975, Emerg; August 15, 1984, Reg; September 28, 2007, Susp ......do do. Pelham, Village of, Westchester County 360925 September 8, 1975, Emerg; April 2, 1979, Reg; September 28, 2007, Susp ......do Do. Pelham Manor, Village of, Westchester County 360926 November 11, 1974, Emerg; January 3, 1979, Reg; September 28, 2007, Susp ......do Do. Peru, Town of, Clinton County 361384 April 16, 1976, Emerg; May 4, 1987, Reg; September 28, 2007, Susp ......do Do. Plattsburg, Town of, Clinton County 360169 May 25, 1973, Emerg; September 28, 1979, Reg; September 28, 2007, Susp ......do Do. Port Chester, Village of, Westchester County 360928 June 20, 1973, Emerg; January 16, 1980, Reg; September 28, 2007, Susp ......do Do. Pound Ridge, Town of, Westchester County 360929 April 21, 1975, Emerg; May 25, 1984, Reg; September 28, 2007, Susp ......do Do. Rouses Point, Village of, Clinton County 360170 August 12, 1975, Emerg; August 4, 1987, Reg; September 28, 2007, Susp ......do Do. Rye, City of, Westchester County 360931 April 23, 1974, Emerg; April 1, 1980, Reg; September 28, 2007, Susp ......do Do. Rye Brook, Village of, Westchester County 360930 July 26, 1973, Emerg; September 28, 1979, Reg; September 28, 2007, Susp ......do Do. Scarsdale, Village of, Westchester County 360932 April 25, 1973, Emerg; June 18, 1980, Reg; September 28, 2007, Susp ......do Do. Sleepy Hollow, Village of, Westchester County 361515 September 12, 1975, Emerg; August 17, 1981, Reg; September 28, 2007, Susp ......do Do. Tuckahoe, Village of, Westchester County 360934 July 2, 1975, Emerg; February 15, 1979, Reg; September 28, 2007, Susp ......do Do. White Plains, City of, Westchester County 360935 October 20, 1972, Emerg; January 2, 1980, Reg; September 28, 2007, Susp ......do Do. Yonkers, City of, Westchester County 360936 April 13, 1973, Emerg; August 15, 1980, Reg; September 28, 2007, Susp ......do Do. Yorktown, Town of, Westchester County 360937 March 28, 1975, Emerg; November 15, 1985, Reg; September 28, 2007, Susp ......do Do. Region III Pennsylvania: Buffalo, Township of, Union County 421237 March 17, 1975, Emerg; April 1, 1977, Reg; September 28, 2007, Susp ......do Do. East Buffalo, Township of, Union County 421011 April 24, 1973, Emerg; February 2, 1977, Reg; September 28, 2007, Susp ......do Do. Gregg, Township of, Union County 420830 May 11, 1973, Emerg; September 28, 1979, Reg; September 28, 2007, Susp ......do Do. Kelly, Township of, Union County 422103 September 19, 1974, Emerg; March 1, 1977, Reg; September 28, 2007, Susp ......do Do. Lewis, Township of, Union County 422104 July 29, 1976, Emerg; September 30, 1987, Reg; September 28, 2007, Susp ......do Do. Lewisburg, Borough of, Union County 420831 November 3, 1972, Emerg; February 2, 1977, Reg; September 28, 2007, Susp ......do Do. Limestone, Township of, Union County 422105 February 13, 1975, Emerg; March 4, 1988, Reg; September 28, 2007, Susp ......do Do. Mifflinburg, Borough of, Union County 420832 May 2, 1975, Emerg; March 4, 1988, Reg; September 28, 2007, Susp ......do Do. New Berlin, Borough of, Union County 420833 November 21, 1975, Emerg; April 30, 1986, Reg; September 28, 2007, Susp ......do Do. Union, Township of, Union County 420834 July 5, 1973, Emerg; August 1, 1979, Reg; September 28, 2007, Susp ......do Do. West Buffalo, Township of, Union County 422106 June 4, 1979, Emerg; September 30, 1987, Reg; September 28, 2007, Susp ......do Do. White Deer, Township of, Union County 421034 October 4, 1973, Emerg; September 28, 1979, Reg; September 28, 2007, Susp ......do Do. Virginia: Augusta County, Unincorporated Areas 510013 July 24, 1974, Emerg; May 17, 1990, Reg; September 28, 2007, Susp ......do Do. Berryville, Town of, Clarke County 510037 March 17, 1975, Emerg; April 1, 1988, Reg; September 28, 2007, Susp ......do Do. Clarke County, Unincorporated Areas 510036 October 13, 1972, Emerg; September 24, 1984, Reg; September 28, 2007, Susp ......do Do. Craigsville, Town of, Augusta County 510014 May 14, 1974, Emerg; April 15, 1986, Reg; September 28, 2007, Susp ......do Do. James City, Unincorporated Areas 510201 October 20, 1975, Emerg; February 6, 1991, Reg; September 28, 2007, Susp ......do Do. Roanoke, City of, Roanoke County 510130 September 11, 1973, Emerg; November 4, 1981, Reg; September 28, 2007, Susp ......do Do. Roanoke County, Unincorporated Areas 510190 October 11, 1973, Emerg; October 17, 1978, Reg; September 28, 2007, Susp ......do Do. Salem, City of, Roanoke County 510141 March 8, 1974, Emerg; September 2, 1981, Reg; September 28, 2007, Susp ......do Do. Stauton, City of, Independent City 510155 December 24, 1974, Emerg; December 1, 1978, Reg; September 28, 2007, Susp ......do Do. Vinton, Town of, Roanoke County 510131 March 6, 1974, Emerg; March 15, 1978, Reg; September 28, 2007, Susp ......do Do. Waynesboro, City of, Independent City 515532 June 19, 1970, Emerg; July 2, 1971, Reg; September 28, 2007, Susp ......do Do. Williamsburg, City of, James City County 510294 October 29, 1975, Emerg; November 20, 1981, Reg; September 28, 2007, Susp ......do Do. Region IV Alabama: Calhoun County, Unincorporated Areas 010013 September 22, 1975, Emerg; September 15, 1983, Reg; September 28, 2007, Susp ......do Do. Moundville, Town of, Tuscaloosa County 010096 October 11, 1974, Emerg; July 18, 1985, Reg; September 28, 2007, Susp ......do Do. Piedmont, City of, Calhoun County 010024 June 25, 1975, Emerg; June 15, 1984, Reg; September 28, 2007, Susp ......do Do. Florida: Altamonte Springs, City of, Seminole County 120290 October 9, 1974, Emerg; March 18, 1980, Reg; September 28, 2007, Susp ......do Do. Casselberry, City of, Seminole County 120291 September 11, 1974, Emerg; July 2, 1980, Reg; September 28, 2007, Susp ......do Do. Lake Mary, City of, Seminole County 120416 September 10, 1976, Emerg; March 18, 1980, Reg; September 28, 2007, Susp ......do Do. Longwood, City of, Seminole County 120292 March 12, 1975, Emerg; March 18, 1980, Reg; September 28, 2007, Susp ......do Do. Seminole County, Unincorporated Areas 120289 May 29, 1974, Emerg; May 5, 1981, Reg; September 28, 2007, Susp ......do Do. Wewahitchka, City of, Gulf County 120100 May 19, 1976, Emerg; May, 17, 1982, Reg; September 28, 2007, Susp ......do Do. Georgia: Adairsville, Town of, Bartown County 130235 January 5, 1979, Emerg; July 30, 1982, Reg; September 28, 2007, Susp ......do Do. Blairsville, Town of, Union County 130179 September 16, 1991, Emerg; June 1, 2005, Reg; September 28, 2007, Susp ......do Do. Emerson, City of, Bartown County 130276 April 19, 1976, Emerg; October 8, 1982, Reg; September 28, 2007, Susp ......do Do. Union County, Unincorporated Areas 130254 October 26, 1984, Emerg; March 1, 1986, Reg; September 28, 2007, Susp ......do Do. White, City of, Bartown County 130278 June 18, 1976, Emerg; June 4, 1982, Reg; September 28, 2007, Susp ......do Do. Kentucky: Clay County, Unincorporated Areas 210057 May 22, 1984, Emerg; January 1, 1987, Reg; September 28, 2007, Susp ......do Do. Frankfort, City of, Franklin County 210075 April 23, 1974, Emerg; July 2, 1981, Reg; September 28, 2007, Susp ......do Do. Franklin County, Unincorporated Areas 210280 January 23, 1976, Emerg; September 30, 1981, Reg; September 28, 2007, Susp ......do Do. Manchester, City of, Clay County 210058 September 2, 1975, Emerg; July 2, 1987, Reg; September 28, 2007, Susp ......do Do. Mississippi: Ackerman, Town of, Choctaw County 280032 April 1, 1975, Emerg; July 3, 1986, Reg; September 28, 2007, Susp ......do Do. North Carolina: Belmont, City of, Gaston County 370320 March 26, 1976, Emerg; November 1 ,1979, Reg; September 28, 2007, Susp ......do Do. Bessemer City, City of, Gaston County 370526 November 26, 2002, Emerg; March 3, 2003, Reg; September 28, 2007, Susp ......do Do. Caswell County, Unincorporated Areas 370300 September 6, 2002, Emerg, Reg; September 28, 2007, Susp ......do Do. Cramerton, Town of, Gaston County 370321 May 21, 1992, Emerg; May 21, 1992, Reg; September 28, 2007, Susp ......do Do. Dallas, Town of, Gaston County 370322 October 7, 1992, Emerg; May 1, 1994, Reg; September 28, 2007, Susp ......do Do. Gaston County, Unincorporated Areas 370099 April 16, 1976, Emerg; May 1, 1980, Reg; September 28, 2007, Susp ......do Do. Gastonia, City of, Gaston County 370100 November 26, 1973, Emerg; February 1, 1978, Reg; September 28, 2007, Susp ......do Do. Lowell, City of, Gaston County 370323 September 15, 1987, Emerg; March 5, 1990, Reg; September 28, 2007, Susp ......do Do. Mcadenville, Town of, Gaston County 370101 September 7, 1979, Emerg; June 1, 1987, Reg; September 28, 2007, Susp ......do Do. Mount Holly, City of, Gaston County 370102 January 15, 1974, Emerg; September 28, 1979, Reg; September 28, 2007, Susp ......do Do. Ranlo, Town of, Gaston County 370324 December 19, 1989 Emerg; March 3, 2003, Reg; September 28, 2007, Susp ......do Do. Yanceyville, Town of, Caswell County 370641 February 8, 2005, Emerg, Reg; September 28, 2007, Susp ......do Do. Tennessee: Bartlett, City of, Shelby County 470175 December 28, 1973, Emerg; June 15, 1981, Reg; September 28, 2007, Susp ......do Do. Bolivar, City of, Hardeman County 470081 September 6, 1985, Emerg; August 19, 1987, Reg; September 28, 2007, Susp ......do Do. Chapel Hill, Town of, Marshall County 470120 June 14, 2002, Emerg; June 14, 2002, Reg; September 28, 2007, Susp ......do Do. Chester County, Unincorporated Areas 470348 November 17, 1994, Emerg; , Reg; September 28, 2007, Susp ......do Do. Collierville, Town of, Shelby County 470263 September 29, 1975, Emerg; September 30, 1981, Reg; September 28, 2007, Susp ......do Do. Cornersville, Town of, Marshall County 470325 June 18, 1984, Emerg; September 1, 1986, Reg; September 28, 2007, Susp ......do Do. Gates, Town of, Lauderdale County 470258 September 16, 1975, Emerg; July 2, 1987, Reg; September 28, 2007, Susp ......do Do. Germantown, City of, Shelby County 470353 October 1, 1975, Emerg; January 20, 1982, Reg; September 28, 2007, Susp ......do Do. Giles County, Unincorporated Areas 470063 April 16, 1999, Emerg; April 16, 1999, Reg; September 28, 2007, Susp ......do Do. Halls, Town of, Lauderdale County 470231 April 30, 1975, Emerg; March 18, 1987, Reg; September 28, 2007, Susp ......do Do. Harriman, City of, Roane County 475427 September 18, 1970, Emerg; February 26, 1971, Reg; September 28, 2007, Susp ......do Do. Henderson, City of, Chester County 470029 July 25, 1975, Emerg; March 18, 1986, Reg; September 28, 2007, Susp ......do Do. Henning, Town of, Lauderdale County 470259 July 21, 1986, Emerg; March 4, 1988, Reg; September 28, 2007, Susp ......do Do. Huntsville, Town of, Scott County 470397 September 26, 1988, Emerg; September 29, 1989, Reg; September 28, 2007, Susp ......do Do. Lauderdale County, Unincorporated Areas 470333 April 14, 1975, Emerg; September 30, 1987, Reg; September 28, 2007, Susp ......do Do. Lynnville, City of, Giles County 470065 February 19, 1999, Emerg; July 1, 2000, Reg; September 28, 2007, Susp ......do Do. Memphis, City of, Shelby County 470177 August 23, 1974, Emerg; December 1, 1982, Reg; September 28, 2007, Susp ......do Do. Millington, City of, Shelby County 470178 November 1, 1974, Emerg; March 16, 1981, Reg; September 28, 2007, Susp ......do Do. Oneida, Town of, Scott County 470170 June 24, 1975, Emerg; June 17, 1986, Reg; September 28, 2007, Susp ......do Do. Pulaski, City of, Giles County 470067 April 14, 1975, Emerg; January 16, 1987, Reg; September 28, 2007, Susp ......do Do. Ripley, Town of, Lauderdale County 470100 January 23, 1975, Emerg; May 19, 1987, Reg; September 28, 2007, Susp ......do Do. Rockwood, City of, Roane County 475443 May 15, 1970, Emerg; May 15, 1970, Reg; September 28, 2007, Susp ......do Do. Shelby County, Unincorporated Areas 470214 May 15, 1974, Emerg; December 1, 1982, Reg; September 28, 2007, Susp ......do Do. Sparta, City of, White County 470203 March 14, 1974, Emerg; November 2, 1977, Reg; September 28, 2007, Susp ......do Do. Region VI Arkansas: Benton County, Unincorporated Areas 050419 April 29, 1988, Emerg; September 18, 1991, Reg; September 28, 2007, Susp ......do Do. Bentonville, City of, Benton County 050012 January 3, 1975, Emerg; July 16, 1980, Reg; September 28, 2007, Susp ......do Do. Bethel Heights, Town of, Benton County 050386 April 19, 1996, Emerg; April 19, 1996, Reg; September 28, 2007, Susp ......do Do. Calion, City of, Union County 050206 October 25, 1974, Emerg; July 2, 1980, Reg; September 28, 2007, Susp ......do Do. Centerton, City of, Benton County 050399 August 14, 1975, Emerg; August 24, 1982, Reg; September 28, 2007, Susp ......do Do. Decatur, City of, Benton County 050319 March 10, 1976, Emerg; January 3, 1986, Reg; September 28, 2007, Susp ......do Do. Elm Springs, City of, Washington County 050213 May 15, 1975, Emerg; April 30, 1986, Reg; September 28, 2007, Susp ......do Do. Felsenthal, Town of, Union County 050574 March 30, 1982, Emerg; June 19, 1985, Reg; September 28, 2007, Susp ......do Do. Gentry, City of, Benton County 050324 March 11, 2005, Emerg; March 11, 2005, Reg; September 28, 2007, Susp ......do Do. Gravette, City of, Benton County 050327 May 17, 1976, Emerg; August 24, 1982, Reg; September 28, 2007, Susp ......do Do. Highfill, Town of, Benton County 050581 July 22, 2003, Emerg; July 22, 2003, Reg; September 28, 2007, Susp ......do Do. Huttig, City of, Union County 050208 June 23, 1975, Emerg; June 4, 1980, Reg; September 28, 2007, Susp ......do Do. Lowell, City of, Benton County 050342 June 1, 1976, Emerg; August 19, 1987, Reg; September 28, 2007, Susp ......do Do. Norphlet, City of, Union County 050356 May 5, 1975, Emerg; June 1, 1987, Reg; September 28, 2007, Susp ......do Do. Pea Ridge, City of, Benton County 050361 November 7, 1975, Emerg; September 1, 1987, Reg; September 28, 2007, Susp ......do Do. Rogers, City of, Benton County 050013 June 12, 1975, Emerg; March 2, 1981, Reg; September 28, 2007, Susp ......do Do. Siloam Springs, City of, Benton County 050014 April 14, 1975, Emerg; November 19, 1980, Reg; September 28, 2007, Susp ......do Do. Smackover, City of, Union County 050209 May 13, 1975, Emerg; July 2, 1980, Reg; September 28, 2007, Susp ......do Do. Springdale, City of, Benton County 050219 September 26, 1974, Emerg; June 15, 1981, Reg; September 28, 2007, Susp ......do Do. Strong, City of, Union County 050210 February 11, 1975, Emerg; April 1, 1981, Reg; September 28, 2007, Susp ......do Do. Union County, Unincorporated Areas 050205 February 7, 1983, Emerg; March 1, 1987, Reg; September 28, 2007, Susp ......do Do. Region VII Missouri: Gainesville, City of, Ozark County 290273 August 20, 1975, Emerg; August 19, 1986, Reg; September 28, 2007, Susp ......do Do. Theodosia, Village of, Ozark County 290306 January 25, 2006, Emerg; -, Reg; September 28, 2007, Susp ......do Do. Region VIII Montana: Flathead County, Unincorporated Areas 300023 October 31, 1975, Emerg; September 5, 1984, Reg; September 28, 2007, Susp ......do Do. Columbia Falls, City of, Flathead County 300024 June 25, 1974, Emerg; October 15, 1985, Reg; September 28, 2007, Susp ......do Do. Whitefish, City of, Flathead County 300026 June 25, 1974, Emerg; October 15, 1985, Reg; September 28, 2007, Susp ......do Do. South Dakota: Watertown, City of, Codington County 460016 February 20, 1975, Emerg; July 4, 1989, Reg; September 28, 2007, Susp ......do Do. Wyoming: Hulett, Town of, Crook County 560016 May 21, 1997, Emerg; April 1, 1999, Reg; September 28, 2007, Susp ......do Do. Region IX Arizona: Apache County, Unincorporated Areas 040001 April 11, 1975, Emerg; July 5, 1982, Reg; September 28, 2007, Susp ......do Do. Clifton, Town of, Greenlee County 040035 January 17, 1975, Emerg; March 1, 1984, Reg; September 28, 2007, Susp ......do Do. Greenlee County, Unincorporated Areas 040110 December 29, 1978, Emerg; July 18, 1985, Reg; September 28, 2007, Susp ......do Do. Region X Oregon: Bend, City of, Deschutes County 410056 March 12, 1975, Emerg; September 4, 1987, Reg; September 28, 2007, Susp ......do Do. Sisters, City of, Deschutes County 410058 August 14, 1975, Emerg; September 29, 1986, Reg; September 28, 2007, Susp ......do Do. *do = Ditto. Code for reading third column: Emerg.—Emergency; Reg.—Regular; Susp.—Suspension. Dated: September 17, 2007. Michael K. Buckley, Deputy Assistant Administrator, Mitigation, Department of Homeland Security, Federal Emergency Management Agency. [FR Doc. E7-18952 Filed 9-25-07; 8:45 am] BILLING CODE 9110-12-P DEPARTMENT OF TRANSPORTATION Office of the Secretary 49 CFR Part 40 Procedures for Transportation Workplace Drug and Alcohol Testing Programs CFR Correction In Title 49 of the Code of Federal Regulations, Parts 1 to 99, revised as of October 1, 2006, the heading for § 40.209, on page 680 is corrected to read as follows: § 40.209 What procedural problems do not result in the cancellation of a test and do not require correction? [FR Doc. 07-55511 Filed 9-25-07; 8:45 am]
Connectionstraces to 36
Traces to 36 documents
U.S. Code
42 references not yet in our index
  • 21 CFR 522
  • 21 CFR 20
  • 5 USC 801-808
  • 31 CFR 10
  • T.D. 9359
  • Pub. L. 108-357
  • 118 Stat. 1418
  • T.D. 9288
  • 26 CFR 300
  • Pub. L. 110-28
  • 121 Stat. 190
  • Pub. L. 109-280
  • 120 Stat. 780
  • 23 Stat. 258
  • 60 Stat. 237
  • 64 Stat. 1280
  • 5 CFR 2637.201(c)
  • 40 CFR 52
  • 40 CFR 97.302
  • 40 CFR 97
  • 40 CFR 96
  • 40 CFR 75
  • 40 CFR 51
  • Pub. L. 104-4
  • 40 CFR 180
  • 40 CFR 178
  • 40 CFR 2
  • 40 CFR 180.582
  • Pub. L. 104-113
  • 40 CFR 180.552
  • 40 CFR 180.315
  • 40 CFR 180.3
  • 40 CFR 180.330(a)(1)
  • 40 CFR 180.6
  • 40 CFR 180.6(b)
  • Pub. L. 104-13
  • 40 CFR 180.249
  • 40 CFR 180.573
  • 44 CFR 64
  • 44 CFR 59
+ 2 more
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cites case law
Rules and Regulations
Final rule
C.F.R.§ 522.2630
U.S.C.§ 360b
C.F.R.§ 25.33
U.S.C.§ 804
U.S.C.§ 207
Fed. Reg.Notices
U.S.C.§ 601
U.S.C.§ 301
U.S.C.§ 321
Cite21 CFR 522
Cite21 CFR 20
Cite5 USC 801-808
Cites 78 · showing 12Cited by 0 across 0 sources
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