Rules and Regulations. Interim rule with request for comments

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BILLING CODE 4710-06-M DEPARTMENT OF JUSTICE 28 CFR Part 72 [Docket No. OAG 117; A.G. Order No. 2868-2007] RIN 1105-AB22 Office of the Attorney General; Applicability of the Sex Offender Registration and Notification Act AGENCY: Department of Justice. ACTION: Interim rule with request for comments. SUMMARY: The Department of Justice is publishing this interim rule to specify that the requirements of the Sex Offender Registration and Notification Act, title I of Public Law 109-248, apply to sex offenders convicted of the offense for which registration is required before the enactment of that Act.

These requirements include registration by a sex offender in each jurisdiction in which the sex offender resides, is an employee, or is a student. The Attorney General has the authority to make this specification pursuant to sections 112(b) and 113(d) of the Sex Offender Registration and Notification Act. DATES: *Effective Date:* This interim rule is effective February 28, 2007. *Comment Date:* Comments must be received by April 30, 2007. ADDRESSES: Comments may be mailed to David J.

Karp, Senior Counsel, Office of Legal Policy, Room 4509, Main Justice Building, 950 Pennsylvania Avenue, NW., Washington, DC 20530. To ensure proper handling, please reference OAG Docket No. 117 on your correspondence. You may view an electronic version of this interim rule at *http://www.regulations.gov.* You may also comment via the Internet to the Justice Department's Office of Legal Policy

(OLP)at *olpregs@usdoj.gov* or by using the www.regulations.gov comment form for this regulation. When submitting comments electronically you must include OAG Docket No. 117 in the subject box. FOR FURTHER INFORMATION CONTACT: Laura L. Rogers, Director, Office of Sex Offender Sentencing, Monitoring, Apprehending, Registering, and Tracking; Office of Justice Programs, United States Department of Justice, Washington, DC, 202 514-4689. SUPPLEMENTARY INFORMATION: Since the enactment of the Jacob Wetterling Crimes Against Children and Sexually Violent Offender Registration Act (42 U.S.C. 14071) in 1994, there have been national standards for sex offender registration and notification in the United States. All states currently have sex offender registration and notification programs and have endeavored to implement the Wetterling Act standards in their existing programs. Title I of the Adam Walsh Child Protection and Safety Act of 2006 (Pub. L. 109-248), the Sex Offender Registration and Notification Act (SORNA), contains a comprehensive revision of the national standards for sex offender registration and notification. The SORNA reforms are generally designed to strengthen and increase the effectiveness of sex offender registration and notification for the protection of the public, and to eliminate potential gaps and loopholes under the pre-existing standards by means of which sex offenders could attempt to evade registration requirements or the consequences of registration violations. Broadly speaking, the SORNA requirements are of two sorts: First, SORNA directly imposes registration obligations on sex offenders as a matter of federal law and provides for federal enforcement of these obligations under circumstances supporting federal jurisdiction. These obligations include registration, and keeping the registration current, in each jurisdiction in which a sex offender resides, is an employee, or is a student, with related provisions concerning such matters as the time for registration, the information to be provided by the registrant, and keeping the information up to date. *See* 42 U.S.C. 16913-16917, enacted by SORNA §§ 113-17. The enforcement mechanisms for these registration obligations include requirements that the Federal Bureau of Prisons and federal probation offices inform offenders released from federal custody or sentenced to probation who are required to register under SORNA that they must comply with SORNA's requirements, as well as requirements that these federal agencies notify state and local authorities concerning the release of such offenders to their areas. *See* 18 U.S.C. 4042(c), as amended by SORNA § 141(f)-(h). Federal offenders subject to SORNA are also obligated to comply with its requirements as mandatory conditions of their supervision. *See* 18 U.S.C. 3563(a)(8), 3583(d), 4209(a), as amended by SORNA § 141(d)-(e), (j). More broadly, 18 U.S.C. 2250, enacted by section 141(a) of SORNA, creates federal criminal liability for any person required to register under SORNA if:

(i)the registration requirement is based on a conviction under federal, District of Columbia, Indian tribal, or U.S. territorial law, or the person travels in interstate or foreign commerce or enters or leaves or resides in Indian country, and

(ii)the person knowingly fails to register or update a registration as required under SORNA. Because circumstances supporting federal jurisdiction—such as conviction for a federal sex offense as the basis for registration, or interstate travel by a state sex offender who then fails to register in the destination state—are required predicates for federal enforcement of the SORNA registration requirements, creation of these requirements for sex offenders is within the constitutional authority of the Federal Government. The second broad aspect of SORNA is incorporation by non-federal jurisdictions of the SORNA standards in their own sex offender registration and notification programs. The affected jurisdictions are the states, the District of Columbia, the principal territories, and Indian tribes to the extent provided in SORNA § 127. *See* 42 U.S.C. 16911(10), enacted by SORNA § 111(10). Section 124 of SORNA generally provides a three-year period for jurisdictions to implement SORNA, subject to possible extension by the Attorney General. *See* 42 U.S.C. 16924. Jurisdictions that fail to substantially implement SORNA within the applicable period are subject to a 10% reduction of federal justice assistance (Byrne Grant) funding. The SORNA provisions cast as directions to jurisdictions and their officials are, in relation to the states, only conditions required to avoid this funding reduction. *See* 42 U.S.C. 16925(d), enacted by SORNA § 125(d). Since the SORNA requirements are only partial funding eligibility conditions in relation to the states, and beyond that apply only to jurisdictions that are generally subject to federal legislative authority under the Constitution (D.C., Indian tribal, and U.S. territorial jurisdictions), creation of these requirements is also within the constitutional authority of the Federal Government. In contrast to SORNA's provision of a three-year grace period for jurisdictions to implement its requirements, SORNA's direct federal law registration requirements for sex offenders are not subject to any deferral of effectiveness. They took effect when SORNA was enacted on July 27, 2006, and currently apply to all offenders in the categories for which SORNA requires registration. As in the Wetterling Act provisions (42 U.S.C. 14071) that preceded SORNA, Congress recognized in SORNA that supplementation of the statutory text by administrative guidance and rules would be helpful, and in some contexts necessary, to fully realize the legislation's objectives. Section 112(b) of SORNA accordingly directs the Attorney General to issue guidelines and regulations to interpret and implement SORNA. In addition, there are provisions in SORNA that identify specific contexts in which clarification or supplementation of the statutory provisions by the Attorney General is contemplated. One of these specific contexts appears in section 113(d) of SORNA, which states that “[t]he Attorney General shall have the authority to specify the applicability of the requirements of this title to sex offenders convicted before the enactment of this Act or its implementation in a particular jurisdiction, and to prescribe rules for the registration of any such sex offenders and for other categories of sex offenders who are unable to comply with subsection (b).” 42 U.S.C. 16913(d). (The cross-referenced “subsection (b)” states the normal timing rules for initial registration by sex offenders—before release for imprisoned offenders, and within three business days of sentencing for offenders not sentenced to imprisonment.) Section 113(d) ensures that there will be a means to resolve issues about the scope of SORNA's applicability, including any questions that may arise concerning the retroactive applicability of its requirements to sex offenders convicted prior to its enactment, and a means to fill any gaps there may be concerning registration procedures or requirements for sex offenders to whom the Act's normal procedures cannot be applied. For example, consider the case of an offender who was convicted of, and sentenced to probation for, a sex offense within the categories for which SORNA requires registration prior to the enactment of SORNA, but who did not register near the time of his sentencing because the offense in question was not subject to a registration requirement under federal law or applicable state law at the time. Following the enactment of SORNA, registration by the sex offender within the normal time period specified in SORNA § 113(b)(2)—not later than three business days after sentencing—is not possible, because that time is past. Under section 113(d), the Attorney General has the authority to specify alternative timing rules for registration of offenders of this type. The purpose of this interim rule is not to address the full range of matters that are within the Attorney General's authority under section 113(d), much less to carry out the direction to the Attorney General in section 112(b) to issue guidelines and regulations to interpret and implement SORNA as a whole. The Attorney General will hereafter issue general guidelines to provide guidance and assistance to the states and other covered jurisdictions in implementing SORNA, as was done under the Wetterling Act, *see* 64 FR 572 (Jan. 5, 1999), and may also issue additional regulations as warranted. The current rulemaking serves the narrower, immediately necessary purpose of foreclosing any dispute as to whether SORNA is applicable where the conviction for the predicate sex offense occurred prior to the enactment of SORNA. This issue is of fundamental importance to the initial operation of SORNA, and to its practical scope for many years, since it determines the applicability of SORNA's requirements to virtually the entire existing sex offender population. Considered facially, SORNA requires all sex offenders who were convicted of sex offenses in its registration categories to register in relevant jurisdictions, with no exception for sex offenders whose convictions predate the enactment of SORNA. *See* SORNA §§ 111(1), (5)-(8), 113(a). Nor is there any *ex post facto* problem in applying the SORNA requirements to such offenders because the SORNA sex offender registration and notification requirements are intended to be non-punitive, regulatory measures adopted for public safety purposes, and hence may validly be applied (and enforced by criminal sanctions) against sex offenders whose predicate convictions occurred prior to the creation of these requirements. *See Smith* v. *Doe,* 538 U.S. 84 (2003). Likewise, in terms of underlying policy, the general purpose of SORNA is to “protect the public from sex offenders and offenders against children” by establishing “a comprehensive national system for the registration of those offenders.” 42 U.S.C. 16901, enacted by SORNA § 102. If SORNA were deemed inapplicable to sex offenders convicted prior to its enactment, then the resulting system for registration of sex offenders would be far from “comprehensive,” and would not be effective in protecting the public from sex offenders because most sex offenders who are being released into the community or are now at large would be outside of its scope for years to come. For example, it would not apply to a sex offender convicted of a rape or child molestation offense in 2005, who is sentenced to imprisonment and released in 2020. Nevertheless, sex offenders with predicate convictions predating SORNA who do not wish to be subject to the SORNA registration requirements, or who wish to avoid being held to account for having violated those requirements, have not been barred from attempting to devise arguments that SORNA is inapplicable to them, e.g., because a rule confirming SORNA's applicability has not been issued. This rule forecloses such claims by making it indisputably clear that SORNA applies to all sex offenders (as the Act defines that term) regardless of when they were convicted. The Attorney General exercises his authority under section 113(d) of SORNA to specify this scope of application for SORNA, regardless of whether SORNA would apply with such scope absent this rule, in order to ensure the effective protection of the public from sex offenders through a comprehensive national system for the registration of such offenders. The rule adds a new Part 72 to 28 CFR with three sections. Section 72.1 explains that the purpose of this rule is to specify the applicability of the SORNA requirements to sex offenders convicted prior to the Act's enactment. Section 72.2 states that terms used in the regulations have the same meaning as in SORNA § 111. Thus, the statutory definitions may be consulted as to the meaning of such terms as “sex offender,” “convicted,” and “jurisdiction.” Section 72.3 states that the SORNA requirements apply to all sex offenders, including sex offenders convicted of their registration offenses before the enactment of SORNA, and provides illustrations. Administrative Procedure Act The implementation of this rule as an interim rule, with provisions for post-promulgation public comments, is based on the “good cause” exceptions found at 5 U.S.C. 553(b)(3)(B) and (d)(3), for circumstances in which “notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. 553(b)(3)(B). The rule specifies that the requirements of the Sex Offender Registration and Notification Act apply to all sex offenders (as defined in that Act), including those convicted of the offense for which registration is required prior to the enactment of the Act. The applicability of the Act's requirements promotes the effective tracking of sex offenders following their release, by means described in sections 112-17 and 119 of the Act, and the availability of information concerning their identities and locations to law enforcement and members of the public, by means described in sections 118 and 121 of the Act. The immediate effectiveness of this rule is necessary to eliminate any possible uncertainty about the applicability of the Act's requirements—and related means of enforcement, including criminal liability under 18 U.S.C. 2250 for sex offenders who knowingly fail to register as required—to sex offenders whose predicate convictions predate the enactment of SORNA. Delay in the implementation of this rule would impede the effective registration of such sex offenders and would impair immediate efforts to protect the public from sex offenders who fail to register through prosecution and the imposition of criminal sanctions. The resulting practical dangers include the commission of additional sexual assaults and child sexual abuse or exploitation offenses by sex offenders that could have been prevented had local authorities and the community been aware of their presence, in addition to greater difficulty in apprehending perpetrators who have not been registered and tracked as provided by SORNA. This would thwart the legislative objective of “protect[ing] the public from sex offenders and offenders against children” by establishing “a comprehensive national system for the registration of those offenders,” SORNA § 102, because a substantial class of sex offenders could evade the Act's registration requirements and enforcement mechanisms during the pendency of a proposed rule and delay in the effectiveness of a final rule. It would accordingly be contrary to the public interest to adopt this rule with the prior notice and comment period normally required under 5 U.S.C. 553(b) or with the delayed effective date normally required under 5 U.S.C. 553(d). Regulatory Flexibility Act The Attorney General, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and by approving it certifies that this regulation will not have a significant economic impact on a substantial number of small entities for the purposes of that Act because the regulation concerns the application of the requirements of the Sex Offender Registration and Notification Act to certain offenders. Executive Order 12866 This regulation has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review,” section 1(b), Principles of Regulation. The Department of Justice has determined that this rule is a “significant regulatory action” under Executive Order 12866, section 3(f), and accordingly this rule has been reviewed by the Office of Management and Budget. Executive Order 13132 This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. There has been substantial consultation with state officials regarding the interpretation and implementation of the Sex Offender Registration and Notification Act. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism assessment. Executive Order 12988—Civil Justice Reform This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988. Unfunded Mandates Reform Act of 1995 This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. Small Business Regulatory Enforcement Fairness Act of 1996 This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996. 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, or innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets. List of Subjects in 28 CFR Part 72 Crime, Information, Law enforcement, Prisons, Prisoners, Records, Probation and parole. For the reasons stated in the preamble, part 72 of chapter I of Title 28 of the Code of Federal Regulations is added to read as follows: PART 72—SEX OFFENDER REGISTRATION AND NOTIFICATION Sec. 72.1 Purpose. 72.2 Definitions. 72.3 Applicability of the Sex Offender Registration and Notification Act. Authority: Pub. L. 109-248, 120 Stat. 587. § 72.1 Purpose. This part specifies the applicability of the requirements of the Sex Offender Registration and Notification Act to sex offenders convicted prior to the enactment of that Act. These requirements include registering and keeping the registration current in each jurisdiction in which a sex offender resides, is an employee, or is a student. The Attorney General has the authority to specify the applicability of the Act's requirements to sex offenders convicted prior to its enactment under sections 112(b) and 113(d) of the Act. § 72.2 Definitions. All terms used in this part that are defined in section 111 of the Sex Offender Registration and Notification Act (title 1 of Pub. L. 109-248) shall have the same definitions in this part. § 72.3 Applicability of the Sex Offender Registration and Notification Act. The requirements of the Sex Offender Registration and Notification Act apply to all sex offenders, including sex offenders convicted of the offense for which registration is required prior to the enactment of that Act. *Example 1.* A sex offender is federally convicted of aggravated sexual abuse under 18 U.S.C. 2241 in 1990 and is released following imprisonment in 2007. The sex offender is subject to the requirements of the Sex Offender Registration and Notification Act and could be held criminally liable under 18 U.S.C. 2250 for failing to register or keep the registration current in any jurisdiction in which the sex offender resides, is an employee, or is a student. *Example 2.* A sex offender is convicted by a state jurisdiction in 1997 for molesting a child and is released following imprisonment in 2000. The sex offender initially registers as required, but disappears after a couple of years and does not register in any other jurisdiction. Following the enactment of the Sex Offender Registration and Notification Act, the sex offender is found to be living in another state and is arrested there. The sex offender has violated the requirement under the Sex Offender Registration and Notification Act to register in each state in which he resides, and could be held criminally liable under 18 U.S.C. 2250 for the violation because he traveled in interstate commerce. Dated: February 16, 2007. Alberto R. Gonzales, Attorney General. [FR Doc. E7-3063 Filed 2-27-07; 8:45 am] BILLING CODE 4410-18-P DEPARTMENT OF THE INTERIOR Minerals Management Service 30 CFR Parts 250 and 253 RIN 1010-AD39 Oil and Gas and Sulphur Operations in the Outer Continental Shelf and Oil Spill Financial Responsibility for Offshore Facilities—Civil Penalties AGENCY: Minerals Management Service (MMS), Interior. ACTION: Final rule. SUMMARY: The MMS is required to review the maximum daily civil penalty assessment allowable under 43 U.S.C. 1350 at least once every 3 years for the purpose of adjusting this amount in accordance with the Consumer Price Index

(CPI)as prepared by the Bureau of Labor Statistics, Department of Labor. The same review and adjustment process is required every 4 years for the maximum daily civil penalty assessment allowable under 33 U.S.C. 2716a. The intended effect is for punitive assessments to keep up with inflation. EFFECTIVE DATE: This final rule becomes effective on March 30, 2007. FOR FURTHER INFORMATION CONTACT: Joanne McCammon, Safety and Enforcement Branch at

(703)787-1292 or e-mail *Joanne.McCammon@mms.gov.* SUPPLEMENTARY INFORMATION: *Background:* The Oil Pollution Act of 1990 (OPA 90) (Pub. L. 101-380) expanded and strengthened MMS's authority to impose penalties for violating regulations promulgated under the Outer Continental Shelf

(OCS)Lands Act. Section 8201 of OPA 90 (43 U.S.C. 1350) authorizes the Secretary of the Interior (Secretary) to assess a civil penalty without providing notice and time for corrective action where a failure to comply with applicable regulations results in a threat of serious, irreparable, or immediate harm or damage to human life or the environment. The goal of the MMS OCS Civil Penalty Program is to ensure safe and clean operations on the OCS. By pursuing, assessing, and collecting civil penalties, the program is designed to encourage compliance with OCS statutes and regulations. Not all regulatory violations warrant a review to initiate civil penalty proceedings; however, violations that cause injury, death, or environmental damage, or pose a threat to human life or the environment, will trigger such review. Every 3 years, in accordance with OPA 90 (43 U.S.C. 1350(b)(1)), MMS analyzes the civil penalty maximum amount in conjunction with the CPI prepared by the U.S. Department of Labor. If an adjustment is necessary, MMS informs the public through the **Federal Register** of the new maximum amount. MMS uses Office of Management and Budget

(OMB)guidelines for determining how penalty amounts should be rounded. In computing this new civil penalty maximum amount, MMS divided the August 2006 CPI of 203.9 by the previously used August 2002 CPI of 180.7. This resulted in a multiplying factor of 1.13. The previous maximum amount of $30,000 per violation per day was multiplied by the 1.13 factor and resulted in a new maximum penalty amount of $33,900. This amount was rounded to $35,000 as per OMB guidelines. The new civil penalty maximum amount is now $35,000 per violation per day. It must be remembered that this is a maximum amount and is only used when a non-compliance issue warrants it. OPA 90 also established civil penalties for failure to comply with financial responsibility regulations. Section 4303 of OPA 90 (33 U.S.C. 2716a) authorized the President (and, by delegation, the Secretary) to assess a civil penalty of up to $25,000 per day for each violation. The Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410) established a 4-year cycle for review and adjustment of all federally imposed civil monetary penalties in order to maintain the deterrent effect of such penalties, and promote compliance with the law. The cost-of-living adjustment process (set out in a note to 28 U.S.C. 2461) is the same as that described above. Applying the multiplying factor of 1.13 to the previous maximum amount of $25,000, results in a new maximum civil penalty of $28,250 per violation per day. However, Section 3720E of the Omnibus Appropriations Act of 1996 (Pub. L. 104-134) included a provision limiting the first adjustment of any civil penalty pursuant to the 1990 Act to 10 percent. This is the first adjustment of 33 U.S.C. 2716a. The new civil penalty maximum amount under 33 U.S.C. 2716a is therefore $27,500 per violation per day. Procedural Matters Regulatory Planning and Review (Executive Order (E.O.) 12866) This final rule is not a significant rule as determined by the OMB and is not subject to review under E.O. 12866.

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

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

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

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

(RFA)The Department of the Interior

(DOI)certifies that this final rule will not have a significant economic effect on a substantial number of small entities under the RFA (5 U.S.C. 601 *et seq.* ). This final rule applies to all lessees that operate on the OCS. Generally, lessees that operate under this rule would fall under the Small Business Administration's

(SBA)North American Industry Classification System Codes 211111, Crude Petroleum and Natural Gas Extraction and 213111, Drilling Oil and Gas Wells. Under these codes, the SBA considers all companies with fewer than 500 employees to be a small business. We estimate that of the 130 lessees that explore for and produce oil and gas on the OCS, approximately 90 are small businesses (70 percent). The primary effect of the final rule is the increase in civil penalties assessed only for those operators that do not comply with Federal OCS regulations. This rule will have no impact on the oil and gas industry operators that comply with Federal OCS regulations. For those operators whose non-compliance results in a civil penalty, the increase resulting from the inflation factor of 1.13 amounts to an increase of less than $170,000 spread over an average of 39 cases per year or slightly under $4,400 additional per case. This is using data over the past 10 years and averaging civil penalties paid and number of cases paid per year. This dollar amount is minor considering the substantial costs of operations on the OCS. This is true for even the smallest of OCS operators. Your comments are important. The Small Business and Agriculture Regulatory Enforcement Ombudsman and 10 Regional Fairness Boards were established to receive comments from small business about Federal agency enforcement actions. The Ombudsman will annually evaluate the enforcement activities and rate each agency's responsiveness to small business. If you wish to comment on the actions of MMS, call 1-888-734-3247. You may comment to the SBA without fear of retaliation. Disciplinary action for retaliation by an MMS employee may include suspension or termination from employment with the DOI. Small Business Regulatory Enforcement Fairness Act (SBREFA) This final rule is not a major rule under the SBREFA (5 U.S.C. 804(2)). This final rule: a. Will not have an annual effect on the economy of $100 million or more. As described above, we estimate an annual increase of $4,400 per civil penalty case. b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. The minor increase in cost will not change the way the oil and gas industry conducts business, nor will it affect regional oil and gas prices. Therefore, it will not cause major cost increases for consumers, the oil and gas industry, or any Government agencies. c. Will not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. Leasing on the U.S. OCS is limited to residents of the U.S. or companies incorporated in the U.S. This final rule will not change that requirement. Unfunded Mandates Reform Act

(UMRA)This final rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The final rule will not have a significant or unique effect on State, local, or tribal governments or the private sector. A statement containing the information required by UMRA (2 U.S.C. 1531 *et seq.* ) is not required. This is because the final rule will not affect State, local, or tribal governments, and the effect on the private sector is small. Takings Implication Assessment (Executive Order 12630) The final rule is not a governmental action capable of interference with constitutionally protected property rights. Thus, MMS did not need to prepare a Takings Implication Assessment according to E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Federalism (Executive Order 13132) With respect to E.O. 13132, this final rule will not have federalism implications. This final rule will not substantially and directly affect the relationship between the Federal and State governments. To the extent that State and local governments have a role in OCS activities, this final rule will not affect that role. Civil Justice Reform (Executive Order 12988) With respect to E.O. 12988, The Office of the Solicitor has determined that the final rule does not unduly burden the judicial system and does meet the requirements of sections 3(a) and 3(b)(2) of the Order. Paperwork Reduction Act

(PRA)of 1995 This final rule does not contain any information collection subject to the PRA, and does not require a submittal to OMB for review and approval under section 3507(d) of the PRA. National Environmental Policy Act

(NEPA)of 1969 The final rulemaking does not introduce requirements that would cause lessees or operators to perform or change any activities on the OCS which would result in environmental impacts beyond those addressed in the NEPA documents associated with the OCS plans. MMS has analyzed this final rule according to the criteria of the NEPA and 516 Department Manual 6, Appendix 10.4C(1), “Issuance and/or modification of regulations.” This final rule does not constitute a major Federal action significantly affecting the quality of the human environment and falls within the categorical exclusion of Appendix 10.4C(1) because the impact of the final rule will be limited to administrative and economic effects. A detailed statement under the NEPA is not required. Energy Supply, Distribution, or Use (Executive Order 13211) Executive Order 13211 requires the agency to prepare a Statement of Energy Effects when it takes a regulatory action that is identified as a significant energy action. This final rule is not a significant energy action, and therefore would not require a Statement of Energy Effects because it: a. Is not a significant regulatory action under E.O. 12866, b. Is not likely to have a significant adverse effect on the supply, distribution, or use of energy, and c. Has not been designated by the Administrator of the Office of Information and Regulatory Affairs, OMB, as a significant energy action. Consultation With Indian Tribes (Executive Order 13175) Under the criteria in E.O. 13175, we have evaluated this final rule and determined that it has no potential effects on federally recognized Indian tribes. There are no Indian or tribal lands on the OCS. List of Subjects in 30 CFR Part 250 Administrative practice and procedure, Continental shelf, Environmental protection, Investigations, Oil and gas exploration, Penalties, Reporting and recordkeeping requirements. 30 CFR Part 253 Continental shelf, Environmental protection, Oil and gas exploration, Penalties, Reporting and recordkeeping requirements. Dated: February 5, 2007. C. Stephen Allred, Assistant Secretary—Land and Minerals Management. For the reasons stated in the preamble, Minerals Management Service

(MMS)amends 30 CFR parts 250 and 253 as follows: PART 250—OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF 1. Authority citation for part 250 continues to read as follows: Authority: 43 U.S.C. 1331 *et seq.* , 31 U.S.C. 9701. 2. Revise § 250.1403 to read as follows: § 250.1403 What is the maximum civil penalty? The maximum civil penalty is $35,000 per day per violation. PART 253—OIL SPILL FINANCIAL RESPONSIBILITY FOR OFFSHORE FACILITIES 3. Authority citation for part 253 is amended to read as follows: Authority: 33 U.S.C. 2701 *et seq.* , 28 U.S.C. 2461

(note)4. In § 253.51, revise paragraph

(a)to read as follows: § 253.51 What are the penalties for not complying with this part?

(a)If you fail to comply with the financial responsibility requirements of OPA at 33 U.S.C. 2716 or with the requirements of this part, then you may be liable for a civil penalty of up to $27,500 per COF per day of violation (that is, each day a COF is operated without acceptable evidence of OSFR). [FR Doc. E7-3427 Filed 2-27-07; 8:45 am] BILLING CODE 4310-MR-P DEPARTMENT OF THE INTERIOR Minerals Management Service 30 CFR Part 250 RIN 1010-AD19 Oil and Gas and Sulphur Operations in the Outer Continental Shelf—Incorporate API RP 65 for Cementing Shallow Water Flow Zones AGENCY: Minerals Management Service (MMS), Interior. ACTION: Final rule. SUMMARY: MMS is incorporating by reference the First Edition of the American Petroleum Institute's Recommended Practice

(RP)for Cementing Shallow Water Flow

(SWF)Zones in Deep Water Wells (API RP 65) into MMS regulations. From 1987 to 2004, at least 113 Outer Continental Shelf

(OCS)wells encountered SWF to varying degrees. While the majority of these wells experienced SWF to only a minor degree, there were instances of severe encounters resulting in abandonment of well sites and loss of wells. This action establishes best practices for cementing wells in deep water areas of the OCS that are prone to SWF. EFFECTIVE DATE: March 30, 2007. The incorporation by reference of the publication listed in the regulation is approved by the Director of the Federal Register as of March 30, 2007. FOR FURTHER INFORMATION CONTACT: Kirk Malstrom, Office of Offshore Regulatory Programs, Regulations and Standards Branch at

(703)787-1751. SUPPLEMENTARY INFORMATION: *Background:* Since 1987, OCS operators have reported encountering SWF problems while drilling in specific areas of the Gulf of Mexico (GOM). Between 1987 and 2004, MMS is aware of at least 113 wells, drilled by approximately 25 different operators, that encountered problems with SWF. General information on SWFs, and maps showing the location of areas in the GOM that have had documented cases of SWF, can be viewed at our Web site: *http://www.gomr.mms.gov/homepg/offshore/safety/wtrflow.html.* This final rule updates the requirements for cementing operations in 30 CFR Part 250 Subpart A—General, and Subpart D—Oil and Gas Drilling Operations. Subpart A is amended to incorporate by reference “API RP 65, Recommended Practice for Cementing SWF Zones in Deep Water Wells,” First Edition, September 2002. Subpart D is amended by adding new subparagraph

(e)to § 250.415, detailing when API RP 65 is to be evaluated by an operator in designing a cementing program. Some of the key points of this final rulemaking include the following: • Use of this standard is not warranted for every OCS well, or for all casing strings in a particular well. Its use is limited to situations where there is a risk of encountering a SWF based upon past drilling activity, seismic data or interpretation, or correlation of data from offset wells in water depths greater than 500 feet (SWF has not been encountered in wells in water depths less than 500 feet). • The risk associated with encountering a SWF is characterized in one of two ways:

(1)An area with an unknown SWF potential, or

(2)an area known to contain a SWF hazard. • For purposes of this final rule, these terms are defined as follows: • *An area with an unknown SWF potential* means a zone or geologic formation where neither the presence nor absence of potential for a SWF has been confirmed. • *An area known to contain a SWF hazard* means a zone or geologic formation for which drilling has confirmed the presence of SWF. • Use of this standard is limited to water depths greater than 500 feet for areas with an unknown SWF potential or areas known to contain a SWF hazard. Data available to the MMS on the 113 wells that have encountered SWF show that the water depths for these wells ranged from approximately 500 feet to 9,675 feet, with an average water depth of 3,560 feet. • As part of an operator's Application for Permit to Drill (Form MMS-123), a statement needs to be included concerning how API RP 65 was evaluated by the operator. The operator must also detail which of the cementing techniques from this standard were used as part of the cementing program for a well drilled in either “areas with an unknown SWF potential” or “areas known to contain a SWF hazard.” This information will be evaluated by MMS during the review of the application for permit to drill, and discussed with the operator as appropriate. • Particular attention should be placed on evaluating, designing, and implementing the cementing programs of both the surface and conductor casing strings in wells requiring review under API RP 65. Data available to the MMS on the 113 wells that have encountered SWF show that the tops of the SWF zones ranged from approximately 450 feet below mud line to 3,005 feet below mud line, with an average depth of encounter of 1,305 feet below mud line. These depths are typical of the setting depths of either conductor or surface casings. *Comments on the Rule:* On May 22, 2006, MMS published a proposed rule (71 FR 29280) to incorporate API RP 65. The public comment period ended on July 21, 2006. MMS received six comments on the proposed rule. All the comments came from companies or organizations working in the oil and gas industry, including ExxonMobil, BP, Devon, BJ Services Company, Schlumberger, and the Offshore Operators Committee (OOC). A majority of the comments addressed similar issues mostly on the bias toward using foam cement to address the SWF issue in sections of the RP. Other comments expressed concern that singling out a specific cementing technique hinders new methods and technology development, and that this RP is not appropriate for other cementing applications. You may view these comments on MMS' Public Connect on-line commenting system at: *http://www.mms.gov/federalregister/PublicComments/APIRP65.htm.* *Discussion of Comments:* *Comment:* Five out of the six comments wanted MMS to omit appendix F of API RP 65. The comments suggest omitting this appendix due to a perceived bias toward use of foam cementing. At the time the RP was developed, foam was the best available cement system for use in combating SWFs. Since development of this standard, new options have been developed that are similarly efficient, i.e., non-compressible systems. A few comments also recommend omitting appendices D and E due to bias toward foam cement. *Response:* MMS agrees that there appears to be a bias toward the use of foam cement in appendices D, E, and F. However, under this final rulemaking, MMS does not require a company to comply with the provisions contained in these appendices or submit any information related to these appendices. MMS views the appendices in this RP as examples and background information. With specific reference to appendix F, even with the apparent bias towards use of foam cement, MMS still views the cementing matrix as a useful tool that can help a company evaluate the performance of their cement jobs and improve upon subsequent cement operations. *Comment:* One comment provided further recommendations and alternate language to change sections 11.1, 11.2, and 11.3 of the RP to eliminate bias towards foam cement. *Response:* MMS does not have the authority to change an API document. While MMS could elect not to incorporate by reference specified provisions of the document, it has instead opted to incorporate API RP 65, First Edition (September 2002) in its entirety. API updates these recommended practices periodically through a consensus-based process. MMS believes it best that the changes suggested by this commenter be proposed to the API review committee so that they can be considered by a cross-section of industry. If the proposals are adopted by API, and incorporated into a revised edition of this RP, MMS would then have the option to consider incorporating the revised edition into the regulations. Procedural Matters Regulatory Planning and Review (Executive Order (E.O.) 12866) This final rule is not a significant rule as determined by the Office of Management and Budget (OMB), and is not subject to review under E.O. 12866.

(1)The final rule will not have an annual effect of $100 million or more on the economy. It will not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. The economic analysis prepared by the MMS indicates that, if the techniques included in API RP 65 are evaluated by operating companies in the planning phases of wells drilled in *Areas with an Unknown SWF Potential* or *Areas Known to Contain a SWF Hazard,* this process will increase the planning costs associated with these wells by no more than $20,000 per well (industry estimate). This cost includes planning associated with a full range of SWF mitigation measures. The measures include casing centralization; pipe movement; use of light weight cements such as a foam system; use of non-compressible systems; proper mud circulation prior to cementing; site selection; the drilling of pilot holes; setting extra strings of casing; use of measurement while drilling technology; pressure while drilling technology; and use of a drilling riser for shallow sections of a deep water well. Today, most lessees conducting operations in SWF-prone areas already use most of these techniques. As a result, additional costs associated with implementing these techniques under this final rule will be negligible. Based on information available to MMS, there have been a total of 1,275 wells drilled on the OCS in water depths of 500 feet or greater during the period 2000-2004. The cost to industry over the past 5 years for SWF mitigation would have been approximately $25.5 million ($20,000 per well × 1,275 wells = $25.5 million) if the evaluations required for this final rule were conducted prior to drilling all of these wells. In reality, a significant number of the 1,275 wells would have been located in areas known to be free of SWF, and would not have required an operating company to implement the techniques included in API RP 65 as part of their well planning efforts, resulting in a significantly lower cost to the offshore industry. Using the well data trends from 2000-2004, in water depths greater than 500 feet, MMS estimates an average of 200 wells will be drilled per year. Using the average of 200 wells, the estimated annual cost to industry will be approximately $4 million ($20,000 per well × 200 wells = $4 million). Based on actual drilling figures, estimated total well costs are in excess of $40 million per well. Industry estimates of $20,000 per well for SWF mitigation represents only 0.05 percent of total well costs. The possible consequences of SWF, well abandonment, or well loss are far more severe than the 0.05 percent of well costs for SWF mitigation. For the above reasons, the final rule will have a minor economic effect on the offshore oil and gas industry.

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

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

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

(RFA)The Department certifies that this final rule will not have a significant economic effect on a substantial number of small entities under the RFA (5 U.S.C. 601 *et seq.* ). The changes in the final rule will affect lessees and operators of leases on the OCS. This could include about 130 active Federal oil and gas lessees. Small lessees that operate under this rule fall under the Small Business Administration's

(SBA)North American Industry Classification System (NAICS) codes 211111, Crude Petroleum and Natural Gas Extraction, and 213111, Drilling Oil and Gas Wells. For these NAICS code classifications, a small company is one with fewer than 500 employees. Based on these criteria, an estimated 70 percent of these companies are considered small. This final rule will therefore affect a substantial number of small entities. As previously stated, there have been a total of 1,275 wells drilled on the OCS in water depths of 500 feet or greater during the period 2000-2004. Of the total 1,275 wells drilled, 1,107 were drilled by large businesses and 168 by small businesses. The 168 wells were drilled by a total of 15 small businesses. The 1,107 large business wells correspond to 87 percent of all wells drilled, leaving 13 percent as small business wells. The final rule will have a minor economic effect on the oil and gas offshore lessees and operators on the OCS, regardless of company size. This is due to the relatively small SWF mitigation costs in relation to the high drilling costs. Because of the high potential costs of SWF, well abandonment, or well loss, in the overwhelming majority of cases operators choose to perform improved and safer well cementing procedures on their own initiative, not because of MMS safety requirements. The final rule will add relatively little to the cost of a well cementing procedure. Thus, there will not be a significant impact on a substantial number of small entities under the RFA (5 U.S.C. 601 *et seq.* ). The final rule will not cause the business practices of any of these companies to change. Your comments are important. The Small Business and Agriculture Regulatory Enforcement Ombudsman and 10 Regional Fairness Boards were established to receive comments from small businesses about Federal agency enforcement actions. The Ombudsman will annually evaluate the enforcement activities and rate each agency's responsiveness to small business. If you wish to comment on the actions of MMS, call 1-888-734-3247. You may comment to the Small Business Administration without fear of retaliation. Disciplinary action for retaliation by an MMS employee may include suspension or termination from employment with the DOI. Small Business Regulatory Enforcement Fairness Act (SBREFA) The final rule is not a major rule under the SBREFA (5 U.S.C. 804(2)). This final rule: a. Will not have an annual effect on the economy of $100 million or more. b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. c. Will not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. Leasing on the OCS is limited to residents of the U.S. or companies incorporated in the U.S. This final rule will not change that requirement. Unfunded Mandates Reform Act

(UMRA)This final rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The final rule will not have a significant or unique effect on State, local, or tribal governments or the private sector. A statement containing the information required by UMRA (2 U.S.C. 1531 *et seq.* ) is not required. Takings Implication Assessment (Executive Order 12630) This final rule is not a governmental action capable of interference with constitutionally protected property rights. Thus, MMS did not need to prepare a Takings Implication Assessment according to E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Federalism (Executive Order 13132) With respect to E.O. 13132, this final rule will not have federalism implications. This final rule will not substantially and directly affect the relationship between the Federal and State governments. To the extent that State and local governments have a role in OCS activities, this final rule will not affect that role. Civil Justice Reform (Executive Order 12988) With respect to E.O. 12988, the Office of the Solicitor has determined that the final rule does not unduly burden the judicial system and does meet the requirements of sections 3(a) and 3(b)(2) of the Order. Paperwork Reduction Act

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

(NEPA)of 1969 This rule does not constitute a major Federal action significantly affecting the quality of the human environment. MMS has analyzed this rule under the criteria of the NEPA and 516 Departmental Manual 6, Appendix 10.4C(1). MMS completed a Categorical Exclusion Review for this action and concluded that “the rulemaking does not represent an exception to the established criteria for categorical exclusion; therefore, preparation of an environmental analysis or environmental impact statement will not be required.” Energy Supply, Distribution, or Use (Executive Order 13211) Executive Order 13211 requires the agency to prepare a Statement of Energy Effects when it takes a regulatory action that is identified as a significant energy action. This final rule is not a significant energy action; and therefore, will not require a Statement of Energy Effects because it: a. Is not a significant regulatory action under E.O. 12866, b. Is not likely to have a significant adverse effect on the supply, distribution, or use of energy, and c. Has not been designated by the Administrator of the Office of Information and Regulatory Affairs, OMB, as a significant energy action. Consultation With Indian Tribes (Executive Order 13175) Under the criteria in E.O. 13175, we have evaluated this final rule and determined that it has no potential effects on federally recognized Indian tribes. There are no Indian or tribal lands on the OCS. List of Subjects in 30 CFR Part 250 Administrative practice and procedure, Continental shelf, Environmental protection, Incorporation by reference, Oil and gas exploration, and Reporting and recordkeeping requirements. Dated: January 31, 2007. C. Stephan Allred, Assistant Secretary—Land and Minerals Management. For the reasons stated in the preamble, the MMS amends 30 CFR part 250 as follows: PART 250—OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF 1. The authority citation for part 250 continues to read as follows: Authority: 43 U.S.C. 1331, *et seq.* , 31 U.S.C. 9701. 2. In § 250.198, the following document incorporated by reference is added to the table in paragraph

(e)in alphanumerical order. § 250.198 Documents incorporated by reference.

(e)* * * Title of documents Incorporated by reference at * * * * * * * API RP 65, Recommended Practice for Cementing Shallow Water Flow Zones in Deep Water Wells, First Edition, September 2002, Product No. G56001 § 250.415(e) * * * * * * * 3. In § 250.415, add a new paragraph

(e)as set forth below. § 250.415 What must my casing and cementing programs include?

(e)a statement of how you evaluated the best practices included in API RP 65, Recommended Practice for Cementing Shallow Water Flow Zones in Deep Water Wells (incorporated by reference as specified in § 250.198), if you drill a well in water depths greater than 500 feet and are in either of the following two areas:

(1)An “area with an unknown shallow water flow potential” is a zone or geologic formation where neither the presence nor absence of potential for a shallow water flow has been confirmed.

(2)An “area known to contain a shallow water flow hazard” is a zone or geologic formation for which drilling has confirmed the presence of shallow water flow. [FR Doc. E7-3426 Filed 2-27-07; 8:45 am] BILLING CODE 4310-MR-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [WV101-6038; FRL-8273-7] Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Update to Materials Incorporated by Reference AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule; Notice of administrative change. SUMMARY: EPA is updating the materials submitted by West Virginia that are incorporated by reference

(IBR)into the State Implementation Plan (SIP). The regulations affected by this update have been previously submitted by the West Virginia Department of Environmental Protection and approved by EPA. This update affects the SIP materials that are available for public inspection at the National Archives and Records Administration (NARA), the Air and Radiation Docket and Information Center located at EPA Headquarters in Washington, DC, and the Regional Office. EFFECTIVE DATE: This action is effective February 28, 2007. ADDRESSES: SIP materials which are incorporated by reference into 40 CFR part 52 are available for inspection at the following locations: Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103; the Air and Radiation Docket and Information Center, EPA Headquarters Library, Room Number 3334, EPA West Building, 1301 Constitution Ave., NW., Washington, DC 20460, and the National Archives and Records Administration. If you wish to obtain materials from a docket in the EPA Headquarters Library, please call the Office of Air and Radiation

(OAR)Docket/Telephone number:

(202)566-1742; or the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call

(202)741-6030, or go to: *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.* FOR FURTHER INFORMATION CONTACT: Harold A. Frankford,

(215)814-2108 or by e-mail at *frankford.harold@epa.gov.* SUPPLEMENTARY INFORMATION: The SIP is a living document which the State revises as necessary to address the unique air pollution problems. Therefore, EPA from time to time must take action on SIP revisions containing new and/or revised regulations to make them part of the SIP. On May 22, 1997 (62 FR 27968), EPA revised the procedures for incorporating by reference Federally-approved SIPs, as a result of consultations between EPA and the Office of the Federal Register (OFR). The description of the revised SIP document, IBR procedures and “Identification of plan” format are discussed in further detail in the May 22, 1997 **Federal Register** document. On February 10, 2005 (70 FR 7024), EPA published a **Federal Register** beginning the new IBR procedure for West Virginia. In this document, EPA is doing the following: 1. Announcing the update to the IBR material as of December 15, 2006. 2. Making corrections to the following entries listed in the paragraph 52.2520(c) chart, as described below: a. 45 CSR 14, “State citation [Chapter 16-20 or 45 CSR]” column—revising the entries for the regulation citation and Sections 45-14-2, 45-14-3, and 45-14-19. b. 45 CSR 14, “Title/subject” column—revising the entry for Section 45-14-25. c. 45 CSR 14, “State effective date” column, all entries—revising the effective date from “6/2/05” to “6/1/05.” d. 45 CSR 19—Adding entries for Tables 45-19A and 45-19B. These tables were part of the regulatory text of 45 CSR 19 which EPA approved as a revision of the West Virginia SIP on November 2, 2006 (71 FR 64668), but were inadvertently omitted from the amended rule for 40 CFR 52.2520(c) published at 71 FR 64670. e. 45 CSR 19, “State citation [Chapter 16-20 or 45 CSR]” column—revising the entries for the regulation citation and Sections 45-14-2, 45-14-3, and 45-14-17. f. 45 CSR 19, “Title/subject” column—revising the entry for Section 45-19-23. g. 45 CSR 19, “State effective date” column, all entries—revising the effective date from “6/2/05” to “6/1/05.” h. 45 CSR 14 and 45 CSR 19, “Additional explanation at 40 CFR 52.2565” column, all entries—adding the SIP effective date for each entry. 3. Making corrections to the title of the “Additional information” column in the paragraph 52.2520(d) chart. EPA has determined that today's rule falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedures Act

(APA)which, upon finding “good cause,” authorizes agencies to dispense with public participation, and section 553(d)(3) which allows an agency to make a rule effective immediately (thereby avoiding the 30-day delayed effective date otherwise provided for in the APA). Today's rule simply codifies provisions which are already in effect as a matter of law in Federal and approved State programs. Under section 553 of the APA, an agency may find good cause where procedures are “impractical, unnecessary, or contrary to the public interest.” Public comment is “unnecessary” and “contrary to the public interest” since the codification only reflects existing law. Immediate notice in the CFR benefits the public by removing outdated citations and incorrect chart entries. Statutory and Executive Order Reviews A. General Requirements Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). B. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the **Federal Register** . This rule is not a “major rule” as defined by 5 U.S.C. 804(2). C. Petitions for Judicial Review EPA has also determined that the provisions of section 307(b)(1) of the Clean Air Act pertaining to petitions for judicial review are not applicable to this action. Prior EPA rulemaking actions for each individual component of the West Virginia SIP compilations had previously afforded interested parties the opportunity to file a petition for judicial review in the United States Court of Appeals for the appropriate circuit within 60 days of such rulemaking action. Thus, EPA sees no need in this action to reopen the 60-day period for filing such petitions for judicial review for this “Identification of plan” reorganization update action for West Virginia. 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 record keeping requirements, Sulfur oxides, Volatile organic compounds. Dated: January 18, 2007. Donald S. Welsh, Regional Administrator, Region III. 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 XX—West Virginia 2. Section 52.2520 is amended by revising paragraphs (b), (c), and

(d)to read as follows: § 52.2520 Identification of plan.

(b)Incorporation by reference.

(1)Material listed as incorporated by reference in paragraphs

(c)and

(d)was approved for incorporation by reference by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Material incorporated as it exists on the date of the approval, and notice of any change in the material will be published in the **Federal Register** . Entries in paragraphs

(c)and

(d)of this section with EPA approval dates on or after December 15, 2006 will be incorporated by reference in the next update to the SIP compilation.

(2)EPA Region III certifies that the rules/regulations provided by EPA at the addresses in paragraph (b)(3) of this section are an exact duplicate of the officially promulgated State rules/regulations which have been approved as part of the State implementation plan as of December 15, 2006.

(3)Copies of the materials incorporated by reference may be inspected at the EPA Region III Office at 1650 Arch Street, Philadelphia, PA 19103; the EPA, Air and Radiation Docket and Information Center, Room Number 3334, EPA West Building, 1301 Constitution Avenue, NW., Washington, DC 20460; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html* .

(c)*EPA-Approved Regulations* EPA-Approved Regulations in the West Virginia SIP State citation [Chapter 16-20 or 45 CSR ] Title/subject State effective date EPA approval date Additional explanation/ citation at 40 CFR § 52.2565 [45 CSR] Series 1 NO X Budget Trading Program as a Means of Control and Reduction of Nitrogen Oxides Section 45-1-1 General 5/1/06 9/28/06 71 FR 56881 Section 45-1-2 Definitions 5/1/06 9/28/06 71 FR 56881 Section 45-1-3 Acronyms 5/1/06 9/28/06 71 FR 56881 Section 45-1-4 NO X Budget Trading Program Applicability 5/1/06 9/28/06 71 FR 56881 Section 45-1-5 Retired Unit Exemption 5/1/06 9/28/06 71 FR 56881 Section 45-1-6 NO X Budget Trading Program Standard Requirements 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-7 Computation of Time 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-10 Authorization and Responsibilities of the NO X Authorized Account Representative 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-11 Alternate NO X Authorized Account Representative 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-12 Changing the NO X Authorized Account Representative and the Alternate NO X Authorized Account Representative; Changes in Owners and Operators 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-13 Account Certificate of Representation 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-14 Objections Concerning the NO X Authorized Account Representative 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-20 General NO X Budget Trading Program Permit Requirements 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-21 NO X Budget Permit Applications 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-22 Information Requirements for NO X Budget Permit Applications 5/1/06 9/28/06 71 FR 56881 Section 45-1-23 NO X Budget Permit Contents 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-24 NO X Budget Permit Revisions 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-30 Compliance Certification Report 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-31 Secretary's and Administrator's Action on Compliance Certifications 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-40 State NO X Trading Program Budget 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-41 Timing Requirements for State NO X Allowance Allocations 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-42 State NO X Allowance Allocations 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-43 Compliance Supplement Pool 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-50 NO X Allowance Tracking System Accounts 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-51 Establishment of Accounts 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-52 NO X Allowance Tracking System Responsibilities of NO X Authorized Account Representative 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-53 Recordation of NO X Allowance Allocations 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-54 Compliance 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-55 NO X Allowance Banking 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-56 Account Error 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-57 Closing of General Accounts 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-60 Submission of NO X Allowance Transfers 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-61 Allowance Transfer Recordation 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-62 Notification 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-70 General Monitoring Requirements 5/1/06 9/28/06 71 FR 56881 Section 45-1-71 Initial Certification and Recertification Procedures 5/1/06 9/28/06 71 FR 56881 Section 45-1-72 Out of Control Periods 5/1/06 9/28/06 71 FR 56881 Section 45-1-73 Notifications 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-74 Recordkeeping and Reporting 5/1/06 9/28/06 71 FR 56881 Section 45-1-75 Petitions 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-76 Additional Requirements to Provide Heat Input Data 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-80 Individual Opt-in Applicability 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-81 Opt-in General Requirements 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-82 Opt-in NO X Authorized Account Representative 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-83 Applying for NO X Budget Opt-in Permit 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-84 Opt-in Process 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-85 NO X Budget Opt-in Permit Contents 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-86 Withdrawal From NO X Budget Trading Program 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-87 Change in Regulatory Status 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-88 NO X Allowance Allocations to Opt-in Units 5/1/02 5/10/02 67 FR 37133 (c)(46) Section 45-1-89 Appeal Procedures 5/1/06 9/28/06 71 FR 56881 New Section. Section 45-1-90 Requirements for Stationary Internal Combustion Engines 5/1/06 9/28/06 71 FR 56881 New Section. Section 45-1-100 Requirements for Emissions of NO X From Cement Manufacturing Kilns 5/1/06 9/28/06 71 FR 56881 [45 CSR] Series 2 To Prevent and Control Particulate Air Pollution From Combustion of Fuel in Indirect Heat Exchangers Section 45-2-1 General 8/31/00 8/11/03 68 FR 47473 (c)(56) Section 45-2-2 Definitions 8/31/00 8/11/03 68 FR 47473 (c)(56) Section 45-2-3 Visible Emissions of Smoke and/or Particulate Matter Prohibited and Standards of Measurement 8/31/00 8/11/03 68 FR 47473 (c)(56) Section 45-2-4 Weight Emission Standards 8/31/00 8/11/03 68 FR 47473 (c)(56) Section 45-2-5 Control of Fugitive Particulate Matter 8/31/00 8/11/03 68 FR 47473 (c)(56) Section 45-2-6 Registration 8/31/00 8/11/03 68 FR 47473 (c)(56) Section 45-2-7 Permits 8/31/00 8/11/03 68 FR 47473 (c)(56) Section 45-2-8 Testing, Monitoring, Recordkeeping, and Reporting 8/31/00 8/11/03 68 FR 47473 (c)(56) Section 45-2-9 Start-ups, Shutdowns, and Malfunctions 8/31/00 8/11/03 68 FR 47473 (c)(56) Section 45-2-10 Variances 8/31/00 8/11/03 68 FR 47473 (c)(56) Section 45-2-11 Exemptions 8/31/00 8/11/03 68 FR 47473 (c)(56) Section 45-2-12 Inconsistency Between Rules 8/31/00 8/11/03 68 FR 47473 (c)(56) Table 45-2A [Total Allowable Particulate Matter Emission Rate for All Type ‘c’ Fuel Burning Units Located at One Plant] 8/31/00 8/11/03 68 FR 47473 (c)(56) 45CSR2 Appendix Compliance Test Procedures for 45CSR2 Section 1 General 8/31/00 8/11/03 68 FR 47473 (c)(56) Section 3 Symbols 8/31/00 8/11/03 68 FR 47473 (c)(56) Section 4 Adoption of Test Methods 8/31/00 8/11/03 68 FR 47473 (c)(56) Section 5 Unit Load and Fuel Quality Requirements 8/31/00 8/11/03 68 FR 47473 (c)(56) Section 6 Minor Exceptions 8/31/00 8/11/03 68 FR 47473 (c)(56) Section 7 Pretest and Post Test General Requirements 8/31/00 8/11/03 68 FR 47473 (c)(56) Section 8 Heat Input Data Measurements 8/31/00 8/11/03 68 FR 47473 (c)(56) Section 9 Computations and Data Analysis 8/31/00 8/11/03 68 FR 47473 (c)(56) [45 CSR] Series 3 To Prevent and Control Air Pollution From the Operation of Hot Mix Asphalt Plants Section 45-3-1 General 8/31/00 10/11/02 67 FR 63270 (c)(48) Section 45-3-2 Definitions 8/31/00 10/11/02 67 FR 63270 (c)(48) Section 45-3-3 Emission of Smoke and/or Particulate Matter Prohibited and Standards of Measurement—Visible 8/31/00 10/11/02 67 FR 63270 (c)(48) Section 45-3-4 Emission of Smoke and/or Particulate Matter Prohibited and Standards of Measurement—Weight Emissions 8/31/00 10/11/02 67 FR 63270 (c)(48) Section 45-3-5 Permits 8/31/00 10/11/02 67 FR 63270 (c)(48) Section 45-3-6 Reports and Testing 8/31/00 10/11/02 67 FR 63270 (c)(48) Section 45-3-7 Variance 8/31/00 10/11/02 67 FR 63270 (c)(48) Section 45-3-8 Circumvention 8/31/00 10/11/02 67 FR 63270 (c)(48) Section 45-3-9 Inconsistency Between Rules 8/31/00 10/11/02 67 FR 63270 (c)(48) [45 CSR] Series 5 To Prevent and Control Air Pollution From the Operation of Coal Preparation Plants, Coal Handling Operations, and Coal Refuse Disposal Areas Section 45-5-1 General 8/31/00 10/7/02 67 FR 62379 (c)(47) Section 45-5-2 Definitions 8/31/00 10/7/02 67 FR 62379 (c)(47) Section 45-5-3 Emission of Particulate Matter Prohibited and Standards of Measurement 8/31/00 10/7/02 67 FR 62379 (c)(47) Section 45-5-4 Control and Prohibition of Particulate Emissions From Coal Thermal Drying Operations of a Coal Preparation Plant 8/31/00 10/7/02 67 FR 62379 (c)(47) Section 45-5-5 Control and Prohibition of Particulate Emissions From an Air Table Operation of a Coal Preparation Plant 10/22/93 7/13/99 64 FR 37681 (c)(42) Section 45-5-6 Control and Prohibition of Fugitive Dust Emissions From Coal Handling Operations and Preparation Plants 8/31/00 10/7/02 67 FR 62379 (c)(47) Section 45-5-7 Standards for Coal Refuse Disposal Areas 8/31/00 10/7/02 67 FR 62379 (c)(47) Section 45-5-8 Burning Coal Refuse Disposal Areas 8/31/00 10/7/02 67 FR 62379 (c)(47) Section 45-5-9 Monitoring of Operations 8/31/00 10/7/02 67 FR 62379 (c)(47) Section 45-5-10 Construction, Modification, and Relocation Permits 8/31/00 10/7/02 67 FR 62379 (c)(47) Section 45-5-11 Operating Permits 8/31/00 10/7/02 67 FR 62379 (c)(47) Section 45-5-12 Reporting and Testing 8/31/00 10/7/02 67 FR 62379 (c)(47) Section 45-5-13 Variance 8/31/00 10/7/02 67 FR 62379 (c)(47) Section 45-5-14 Transfer of Permits 8/31/00 10/7/02 67 FR 62379 (c)(47) Section 45-5-15 Inconsistency Between Rules 8/31/00 10/7/02 67 FR 62379 (c)(47) Appendix Particulate Emission Limitations and Operational Monitoring Requirements Applicable to Thermal Dryers Installed Before October 24, 1974 8/31/00 10/7/02 67 FR 62379 (c)(47) [45 CSR] Series 6 To Prevent and Control Air Pollution From Combustion of Refuse Section 45-6-1 General 7/1/01 2/10/03 68 FR 6627 (c)(51) Section 45-6-2 Definitions 7/1/01 2/10/03 68 FR 6627 (c)(51) Section 45-6-3 Open Burning Prohibited 7/1/01 2/10/03 68 FR 6627 (c)(51) Section 45-6-4 Emission Standards for Incinerators and Incineration 7/1/01 2/10/03 68 FR 6627 (c)(51) Section 45-6-5 Registration 7/1/01 2/10/03 68 FR 6627 (c)(51) Section 45-6-6 Permits 7/1/01 2/10/03 68 FR 6627 (c)(51) Section 45-6-7 Reports and Testing 7/1/01 2/10/03 68 FR 6627 (c)(51) Section 45-6-8 Variances 7/1/01 2/10/03 68 FR 6627 (c)(51) Section 45-6-9 Emergencies and Natural Disasters 7/1/01 2/10/03 68 FR 6627 (c)(51) Section 45-6-10 Effect of the Rule 7/1/01 2/10/03 68 FR 6627 (c)(51) Section 45-6-11 Inconsistency Between Rules 7/1/01 2/10/03 68 FR 6627 (c)(51) [45 CSR] Series 7 To Prevent and Control Particulate Matter Air Pollution From Manufacturing Process Operations Section 45-7-1 General 08/31/00 06/03/03 68 FR 33010 (c)(55) Section 45-7-2 Definitions 08/31/00 06/03/03 68 FR 33010 (c)(55) Section 45-7-3 Emission of Smoke and/or Particulate Matter Prohibited and Standards of Measurement 08/31/00 06/03/03 68 FR 33010 (c)(55) Section 45-7-4 Control and Prohibition of Particulate Emissions by Weight From Manufacturing Process Source Operations 08/31/00 06/03/03 68 FR 33010 (c)(55) Section 45-7-5 Control of Fugitive Particulate Matter 08/31/00 06/03/03 68 FR 33010 (c)(55) Section 45-7-6 Registration 08/31/00 06/03/03 68 FR 33010 (c)(55) Section 45-7-7 Permits 08/31/00 06/03/03 68 FR 33010 (c)(55) Section 45-7-8 Reporting and Testing 08/31/00 06/03/03 68 FR 33010 (c)(55) Section 45-7-9 Variance 08/31/00 06/03/03 68 FR 33010 (c)(55) Section 45-7-10 Exemptions 08/31/00 06/03/03 68 FR 33010 (c)(55) Section 45-7-11 Alternative Emission Limits for Duplicate Source Operations 08/31/00 06/03/03 68 FR 33010 (c)(55) Section 45-7-12 Inconsistency Between Rules. 08/31/00 06/03/03 68 FR 33010 (c)(55) Table 45-7A, Table 45-7B [Maximum Allowable Emission Rates From Sources Governed by 45 CFR Series 7] 08/31/00 06/03/03 68 FR 33010 (c)(55) [Ch. 16-20] TP-4 Compliance Test Procedures for Regulation VII—“To Prevent and Control Particulate Air Pollution From Manufacturing Process Operations” Section 1 General 2/23/84 6/28/85 45 FR 26732 no

(c)number; Section 2 Visible Emission Test Procedure 2/23/84 6/28/85 45 FR 26732 no

(c)number; Section 3 Mass Emission Test Procedures 2/23/84 6/28/85 45 FR 26732 no

(c)number; [45 CSR] Series 8 Ambient Air Quality Standards for Sulfur Oxides and Particulate Matter Section 45-8-1 General 4/25/90 6/28/93 58 FR34526 (c)(28) Section 45-8-2 Definitions 4/25/90 6/28/93 58 FR34526 (c)(28) Section 45-8-3 Ambient Air Quality Standards 4/25/90 6/28/93 58 FR34526 (c)(28) Section 45-8-4 Methods of Measurement 4/25/90 6/28/93 58 FR34526 (c)(28) Section 45-8-5 Inconsistency Between Regulations 4/25/90 6/28/93 58 FR34526 (c)(28) [45 CSR] Series 9 Ambient Air Quality Standards for Carbon Monoxide and Ozone Section 45-9-1 General 6/1/00 10/7/02 67 FR 62381 (c)(50) Section 45-9-2 Anti-Degradation Policy 6/1/00 10/7/02 67 FR 62381 (c)(50) Section 45-9-3 Definitions 6/1/00 10/7/02 67 FR 62381 (c)(50) Section 45-9-4 Ambient Air Quality Standards 6/1/00 10/7/02 67 FR 62381 (c)(50) Section 45-9-5 Methods of Measurement 6/1/00 10/7/02 67 FR 62381 (c)(50) [45 CSR] Series 10 To Prevent and Control Air Pollution From The Emission of Sulfur Oxides Section 45-10-1 General 8/31/00 6/3/03 68 FR 33002 (c)(53) Section 45-10-2 Definitions 8/31/00 6/3/03 68 FR 33002 (c)(53) Section 45-10-3 Sulfur Dioxide Weight Emission Standards for Fuel Burning Units 8/31/00 6/3/03 68 FR 33002 (c)(53) Section 45-10-4 Standards for Manufacturing Process Source Operations 8/31/00 6/3/03 68 FR 33002 (c)(53) Section 45-10-5 Combustion of Refinery or Process Gas Streams. 8/31/00 6/3/03 68 FR 33002 (c)(53) Section 45-10-6 Registration 8/31/00 6/3/03 68 FR 33002 (c)(53) Section 45-10-7 Permits 8/31/00 6/3/03 68 FR 33002 (c)(53) Section 45-10-8 Testing, Monitoring, Recordkeeping and Reporting 8/31/00 6/3/03 68 FR 33002 (c)(53) Section 45-10-9 Variance 8/31/00 6/3/03 68 FR 33002 (c)(53) Section 45-10-10 Exemptions and Recommendations 8/31/00 6/3/03 68 FR 33002 (c)(53) Section 45-10-11 Circumvention 8/31/00 6/3/03 68 FR 33002 (c)(53) Section 45-10-12 Inconsistency Between Rules 8/31/00 6/3/03 68 FR 33002 (c)(53) Table 45-10A [Priority Classifications] 8/31/00 6/3/03 68 FR 33002 (c)(53) Table 45-10B [Allowable Percent Sulfur Content of Fuels] 8/31/00 6/3/03 68 FR 33002 (c)(53) [45 CSR] Series 11 Prevention of Air Pollution Emergency Episodes Section 45-11-1 General 4/25/90 6/28/93 58 FR34526 (c)(28) Section 45-11-2 Definitions 4/25/90 6/28/93 58 FR34526 (c)(28) Section 45-11-3 Episode Criteria 4/25/90 6/28/93 58 FR34526 (c)(28) Section 45-11-4 Methods of Measurement 4/25/90 6/28/93 58 FR34526 (c)(28) Section 45-11-5 Preplanned Reduction Strategies 4/25/90 6/28/93 58 FR34526 (c)(28) Section 45-11-6 Emission Reduction Plans 4/25/90 6/28/93 58 FR34526 (c)(28) Table I Emission Reduction Plans-Alert Level 4/25/90 6/28/93 58 FR34526 (c)(28) Table II Emission Reduction Plans-Warning Level 4/25/90 6/28/93 58 FR34526 (c)(28) Table III Emission Reduction Plans-Emergency Level 4/25/90 6/28/93 58 FR34526 (c)(28) Section 45-11-7 Air Pollution Emergencies; Contents of Order; Hearings; Appeals 4/25/90 6/28/93 58 FR34526 (c)(28) Section 45-11-8 Inconsistency Between Regulations 4/25/90 6/28/93 58 FR34526 (c)(28) [45 CSR] Series 12 Ambient Air Quality Standard for Nitrogen Dioxide Section 45-12-1 General 6/1/00 10/7/02 67 FR 62378 (c)(49) Section 45-12-2 Anti-Degradation Policy 6/1/00 10/7/02 67 FR 62378 (c)(49) Section 45-12-3 Definitions 6/1/00 10/7/02 67 FR 62378 (c)(49) Section 45-12-4 Ambient Air Quality Standard 6/1/00 10/7/02 67 FR 62378 (c)(49) Section 45-12-5 Methods of Measurement 6/1/00 10/7/02 67 FR 62378 (c)(49) [45 CSR] Series 13 Permits for Construction, Modification, Relocation and Operation of Stationary Sources of Air Pollutants, Notification Requirements, Temporary Permits, General Permits, and Procedures for Evaluation Section 45-13-1 General 6/1/00 2/28/03 68 FR 9559 (c)(52) Section 45-13-2 Definitions 6/1/00 2/28/03 68 FR 9559 (c)(52) Section 45-13-3 Reporting Requirements for Stationary Sources 6/1/00 2/28/03 68 FR 9559 (c)(52) Section 45-13-4 Administrative Updates to Existing Permits 6/1/00 2/28/03 68 FR 9559 (c)(52) Section 45-13-5 Permit Application and Reporting Requirements for Construction of and Modifications to Stationary Sources 6/1/00 2/28/03 68 FR 9559 (c)(52) Section 45-13-6 Determination of Compliance of Stationary Sources 6/1/00 2/28/03 68 FR 9559 (c)(52) Section 45-13-7 Modeling 6/1/00 2/28/03 68 FR 9559 (c)(52) Section 45-13-8 Public Review Procedures 6/1/00 2/28/03 68 FR 9559 (c)(52) Section 45-13-9 Public Meetings 6/1/00 2/28/03 68 FR 9559 (c)(52) Section 45-13-10 Permit Transfer, Suspension, Revocation and Responsibility 6/1/00 2/28/03 68 FR 9559 (c)(52) Section 45-13-11 Temporary Construction or Modification Permits 6/1/00 2/28/03 68 FR 9559 (c)(52) Section 45-13-12 Permit Application Fees 6/1/00 2/28/03 68 FR 9559 (c)(52) Section 45-13-13 Inconsistency Between Rules 6/1/00 2/28/03 68 FR 9559 (c)(52) Section 45-13-14 Statutory Air Pollution 6/1/00 2/28/03 68 FR 9559 (c)(52) Section 45-13-15 Hazardous Air Pollutants 6/1/00 2/28/03 68 FR 9559 (c)(52) Table 45-13A Potential Emission Rate 6/1/00 2/28/03 68 FR 9559 (c)(52) Table 45-13B De Minimus Sources 6/1/00 2/28/03 68 FR 9559 (c)(52) [45 CSR] Series 14 Permits for Construction and Major Modification of Major Stationary Sources of Air Pollution for the Prevention of Significant Deterioration Section 45-14-1 General 6/1/05 11/2/06 71 FR 64470 SIP effective date is 12/04/06. Section 45-14-2 (Except: 14-2.17, 14-2.40.i, 14-2.46.d.2, 14-2.46.g, and 14-2.56) Definitions 6/1/05 11/2/06 71 FR 64470 SIP effective date is 12/04/06. Section 45-14-3 (Except: 4-3.4.e, 14-3.4.f (part), and 14-3.6) Applicability 6/1/05 11/2/06 71 FR 64470 New Section. SIP effective date is 12/04/06. Section 45-14-4 Ambient Air Quality Increments and Ceilings 6/1/05 11/2/06 71 FR 64470 Formerly Section 45-14-3; SIP effective date is 12/04/06. Section 45-14-5 Area Classification 6/1/05 11/2/06 71 FR 64470 Formerly Section 45-14-4; SIP effective date is 12/04/06. Section 45-14-6 Prohibition of Dispersion Enhancement Techniques 6/1/05 11/2/06 71 FR 64470 Formerly Section 45-14-5; SIP effective date is 12/04/06. Section 45-14-7 Registration, Report and Permit Requirements for Major Stationary Sources and Major Modifications 6/1/05 11/2/06 71 FR 64470 Formerly Section 45-14-6; SIP effective date is 12/04/06. Section 45-14-8 Requirements Relating to Control Technology 6/1/05 11/2/06 71 FR 64470 Formerly Section 45-14-7; SIP effective date is 12/04/06. Section 45-14-9 Requirements Relating to the Source's Impact on Air Quality 6/1/05 11/2/06 71 FR 64470 Formerly Section 45-14-8; SIP effective date is 12/04/06. Section 45-14-10 Modeling Requirements 6/1/05 11/2/06 71 FR 64470 Formerly Section 45-14-9. Section 45-14-11 Air Quality Monitoring Requirements 6/1/05 11/2/06 71 FR 64470 Formerly Section 45-14-10; SIP effective date is 12/04/06. Section 45-14-12 Additional Impacts Analysis Requirements 6/1/05 11/2/06 71 FR 64470 Formerly Section 45-14-11; SIP effective date is 12/04/06. Section 45-14-13 Additional Requirements and Variances for Sources Impacting Federal Class I Areas 6/1/05 11/2/06 71 FR 64470 Formerly Section 45-14-12; SIP effective date is 12/4/06. Section 45-14-14 Procedures for Sources Employing Innovative Control Technology 6/1/05 11/2/06 71 FR 64470 Formerly Section 45-14-13; SIP effective date is 12/4/06. Section 45-14-15 Exclusions From Increment Consumption 6/1/05 11/2/06 71 FR 64470 Formerly Section 45-14-14; SIP effective date is 12/4/06. Section 45-14-16 Specific Exemptions 6/1/05 11/2/06 71 FR 64470 Formerly Section 45-14-15; SIP effective date is 12/4/06. Section 45-14-17 Public Review Procedures 6/1/05 11/2/06 71 FR 64470 Formerly Section 45-14-16; SIP effective date is 12/04/06. Section 45-14-18 Public Meetings 6/1/05 11/2/06 71 FR 64470 Formerly Section 45-14-17; SIP effective date is 12/4/06. Section 45-14-19 (except part of 19-19.8) Permit Transfer, Cancellation, and Responsibility 6/1/05 11/2/06 71 FR 64470 Formerly Section 45-14-18; SIP effective date is 12/4/06. Section 45-14-20 Disposition of Permits 6/1/05 11/2/06 71 FR 64470 Formerly Section 45-14-19; SIP effective date is 12/4/06. Section 45-14-21 Conflict with Other Permitting Rules 6/1/05 11/2/06 71 FR 64470 Formerly Section 45-14-20; SIP effective date is 12/4/06. Section 45-14-25 Actuals PALs 6/1/05 11/2/06 71 FR 64470 New Section. SIP effective date is 12/4/06. Section 45-14-26 Inconsistency Between Rules 6/1/05 11/2/06 71 FR 64470 New Section. SIP effective date is 12/4/06. [45 CSR] Series 19 Permits for Construction and Major Modification of Major Stationary Sources of Air Pollution Which Cause or Contribute to Nonattainment Section 45-19-1 General 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Section 45-19-2 (Except: 19-2.16, 19-2.33.c.8, 19-2.39.b.2.C, 19-2.39.b.5, and 19-2.53) Definitions 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Section 45-19-3 (Except: 19-3.4.e, 19-3.4.f (part), and 19-3.6) Applicability 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Section 45-19-4 Conditions for a Permit Approval for Proposed Major Sources that Would Contribute to a Violation of NAAQS 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Section 45-19-5 Conditions for Permit Approval for Sources Locating In Attainment or Unclassifiable Areas that Would Cause a New Violation of a NAAQS 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Section 45-19-7 Baseline for Determining Credit for Emission Offsets 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Section 45-19-8 Location of Emissions Offsets 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Section 45-19-9 Administrative Procedures for Emission Offset Proposals 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Section 45-19-12 Reasonable Further Progress 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Section 45-19-13 Source Impact Analysis 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Section 45-19-14 Permit Requirements for Major Stationary Sources and Major Modifications 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Section 45-19-15 Public Review Procedures 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Section 45-19-16 Public Meetings 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Section 45-19-17 (Except part of 19-17.4) Permit Transfer, Cancellation and Responsibility 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Section 45-19-18 Disposition of Permits 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Section 45-19-19 Requirements for Air Quality Models 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Section 45-19-23 Actuals PAL 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Section 45-19-24 Conflict with Other Permitting Rules 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Section 45-19-25 Inconsistency Between Rules 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Table 45-19A No Title [Table of Significance Levels] 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. Table 45-19B Averaging Time (hours) 6/1/05 11/2/06 71 FR 64468 SIP effective date is 12/4/06. [45 CSR] Series 20 Good Engineering Practice as Applicable to Stack Heights Section 45-20-1 General 7/14/89 4/19/94 59 FR 18489 (c)(27) Section 45-20-2 Definitions 7/14/89 4/19/94 59 FR 18489 (c)(27) Section 45-20-3 Standards 7/14/89 4/19/94 59 FR 18489 (c)(27) Section 45-20-4 Public Review Procedures 7/14/89 4/19/94 59 FR 18489 (c)(27) Section 45-20-5 Inconsistency Between Regulations 7/14/89 4/19/94 59 FR 18489 (c)(27) [45 CSR] Series 21 Regulation to Prevent and Control Air Pollution From the Emission of Volatile Organic Compounds Section 45-21-1 General 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-2 Definitions 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-3 Applicability 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-4 Compliance Certification, Recordkeeping, and Reporting Procedures for Coating Sources 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-5 Compliance Certification, Recordkeeping, and Reporting Requirements for Non-Coating Sources 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-6 Requirements for Sources Complying by Use of Control Devices 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-7 Circumvention 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-8 Handling, Storage, and Disposal of Volatile Organic Compounds

(VOCs)7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-9 Compliance Programs, Registration, Variance, Permits, Enforceability 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-11 Can Coating 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-12 Coil Coating 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-14 Fabric Coating 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-15 Vinyl Coating 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-16 Coating of Metal Furniture 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-17 Coating of Large Appliances 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-18 Coating of Magnet Wire 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-19 Coating of Miscellaneous Metal Parts 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-21 Bulk Gasoline Plants 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-22 Bulk Gasoline Terminals 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-23 Gasoline Dispensing Facility—Stage I Vapor Recovery 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-24 Leaks From Gasoline Tank Trucks 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-25 Petroleum Refinery Sources 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-26 Leaks From Petroleum Refinery Equipment 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-27 Petroleum Liquid Storage in External Floating Roof Tanks 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-28 Petroleum Liquid Storage in Fixed Roof Tanks 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-29 Leaks From Natural Gas/Gasoline Processing Equipment 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-31 Cutback and Emulsified Asphalt 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-39 Air Oxidation Processes in the Synthetic Organic Chemical Manufacturing Industry 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-41 Test Methods and Compliance Procedures: General Provisions 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-42 Test Methods and Compliance Procedures: Determining the Volatile Organic Compound

(VOC)Content of Coatings and Inks 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-43 Test Methods and Compliance Procedures: Alternative Compliance Methods for Surface Coating 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-44 Test Methods and Compliance Procedures: Emission Capture and Destruction or Removal Efficiency and Monitoring Requirements 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-45 Test Methods and Compliance Procedures: Determining the Destruction or Removal Efficiency of a Control Device 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-46 Test Methods and Compliance Procedures: Leak Detection Methods for Volatile Organic Compounds

(VOCs)7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-47 Performance Specifications for Continuous Emissions Monitoring of Total Hydrocarbons 7/7/93 2/1/95 60 FR 6022 (c)(33) Section 45-21-48 Quality Control Procedures for Continuous Emission Monitoring Systems

(CEMS)7/7/93 2/1/95 60 FR 6022 (c)(33) Appendix A VOC Capture Efficiency 7/7/93 2/1/95 60 FR 6022 (c)(33) [45 CSR] Series 26 NO X Budget Trading Program as a Means of Control and Reduction of Nitrogen Oxides From Electric Generating Units Section 45-26-1 General 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-2 Definitions 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-3 Measurements, Abbreviations and Acronyms 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-4 NO X Budget Trading Program Applicability 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-5 Retired Unit Exemption 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-6 NO X Budget Trading Program Standard Requirements 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-7 Computation of Time 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-10 Authorization and Responsibilities of the NO X Authorized Account Representative 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-11 Alternate NO X Authorized Account Representative 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-12 Changing the NO X Authorized Account Representative and the Alternate NO X Authorized Account Representative; Changes in Owners and Operators 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-13 Account Certificate of Representation 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-14 Objections Concerning the NO X Authorized Account Representative 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-20 General NO X Budget Trading Program Permit Requirements 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-21 NO X Budget Permit Applications 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-22 Information Requirements for NO X Budget Permit Applications 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-23 NO X Budget Permit Contents 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-24 NO X Budget Permit Revisions 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-30 Compliance Certification Report 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-31 Secretary's and Administrator's Action on Compliance Certifications 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-40 State NO X Trading Program Budget 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-41 Timing Requirements for State NO X Allowance Allocations 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-42 State NO X Allowance Allocations 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-43 Compliance Supplement Pool 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-50 NO X Allowance Tracking System Accounts 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-51 Establishment of Accounts 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-52 NO X Allowance Tracking System Responsibilities of NO X Authorized Account Representative 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-53 Recordation of NO X Allowance Allocations 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-54 Compliance 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-55 NO X Allowance Banking 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-56 Account Error 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-57 Closing of General Accounts 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-60 Submission of NO X Allowance Transfers 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-61 Allowance Transfer Recordation 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-62 Notification 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-70 General Monitoring Requirements 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-71 Initial Certification and Recertification Procedures 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-72 Out of Control Periods 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-73 Notifications 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-74 Recordkeeping and Reporting 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-75 Petitions 5/1/02 5/10/02 67 FR 31733 (c)(46) Section 45-26-76 Additional Requirements to Provide Heat Input Data 5/1/02 5/10/02 67 FR 31733 (c)(46) [45 CSR] Series 29 Rule Requiring the Submission of Emission Statements for Volatile Organic Compound Emissions and Oxides of Nitrogen Emissions Section 45-29-1 General 7/7/93 8/4/95 60 FR 39855 (c)(34) Section 45-29-2 Definitions 7/7/93 8/4/95 60 FR 39855 (c)(34) Section 45-29-3 Applicability 7/7/93 8/4/95 60 FR 39855 (c)(34) Section 45-29-4 Compliance Schedule 7/7/93 8/4/95 60 FR 39855 (c)(34) Section 45-29-5 Emission Statement Requirements 7/7/93 8/4/95 60 FR 39855 (c)(34) Section 45-29-6 Enforceability 7/7/93 8/4/95 60 FR 39855 (c)(34) Section 45-29-7 Severability 7/7/93 8/4/95 60 FR 39855 (c)(34) [45 CSR] Series 35 Requirements for Determining Conformity of General Federal Actions to Applicable Air Quality Implementation Plans (General Conformity) Section 45-35-1 General 5/1/95 9/5/95 60 FR 46029 (c)(37) Section 45-35-2 Definitions 5/1/95 9/5/95 60 FR 46029 (c)(37) Section 45-35-3 Adoption of Criteria, Procedures and Requirements 5/1/95 9/5/95 60 FR 46029 (c)(37) Section 45-35-4 Requirements 5/1/95 9/5/95 60 FR 46029 (c)(37)

(d)*EPA approved state source-specific requirements.* EPA-Approved Source Specific Requirements Source name Permit/order or registration number State effective date EPA approval date Additional explanation/citation at 40 CFR § 52.2565 Mountaineer Carbon Co Consent Order 7/2/82 9/1/82 47 FR 38532 (c)(18) National Steel Corp.—Weirton Steel Division Consent Order (Bubble) 7/6/82 12/9/82 47 FR 55396 (c)(19) Columbia Gas Transmission Corporation—Lost River Station Consent Order 9/12/90 4/24/91 56 FR 18733 (c)(24) Wheeling-Pittsburgh Steel Corp Consent Order CO-SIP-91-29 11/14/91 7/25/94 59 FR 37696 (c)(26) Standard Lafarge Consent Order CO-SIP-91-30 11/14/91 7/25/94 59 FR 37696 (c)(26) Follansbee Steel Corp Consent Order CO-SIP-91-31 11/14/91 7/25/94 59 FR 37696 (c)(26) Koppers Industries, Inc Consent Order CO-SIP-91-32 11/14/91 7/25/94 59 FR 37696 (c)(26) International Mill Service, Inc Consent Order CO-SIP-91-33 11/14/91 7/25/94 59 FR 37696 (c)(26) Starvaggi Industries, Inc Consent Order CO-SIP-91-34 11/14/91 7/25/94 59 FR 37696 (c)(26) Quaker State Corporation Consent Order CO-SIP-95-1 1/9/95 11/27/96 61 FR 60191 (c)(35) Weirton Steel Corporation Consent Order CO-SIP-95-2 1/9/95 11/27/96 61 FR 60191 (c)(35) PPG Industries, Inc Consent Order CO-SIP-2000-1 1/25/00 8/2/00 65 FR 47339 (c)(44)(i)(B)( *1* ) Bayer Corporation Consent Order CO-SIP-2000-2 1/26/00 8/2/00 65 FR 47339 (c)(44)(i)(B)( *2* ) Columbian Chemicals Company Consent Order CO-SIP-2000-3 1/31/00 8/2/00 65 FR 47339 (c)(44)(i)(B)( *3* ) PPG Industries, Inc Consent Order CO-SIP-C-2003-27 7/29/03 4/28/04 69 FR 23110 (c)(58) Wheeling-Pittsburgh Steel Corporation Operating Permit R13-1939A 8/19/03 05/05/04 69 FR 24986 (c)(59)(i)(B)( *1* ) Weirton Steel Corporation Consent Order, CO-SIP-C-2003-28 8/4/03 05/05/04 69 FR 24986 (c)(59)(i)(B)( *2* ) [FR Doc. E7-3318 Filed 2-27-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0603 FRL-8114-9] 2-Propenoic Acid, Methyl Ester, Polymer with Ethenyl Acetate, Hydrolyzed, Sodium Salts; Tolerance Exemption AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts (CAS Reg. No. 886993-11-9) when used as an inert ingredient in a pesticide chemical formulation. MonoSol, LLC submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996

(FQPA)requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts. DATES: This regulation is effective February 28, 2007. Objections and requests for hearings must be received on or before April 30, 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-2006-0603. All documents in the docket are listed in the index for the docket. 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 Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Bipin Gandhi, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)308-8380; e-mail address: *gandhi.bipin@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 the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0603 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before April 30, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0603, by one of the following methods. • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of July 26, 2006 (71 FR 42393) (FRL-8079-5), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 6E7085) by MonoSol, LLC, 1701 County Line Road, Portage, IN 46368. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts; CAS Reg. No. 886993-11-9. That notice included a summary of the petition prepared by the petitioner. There were no comments in response to the notice of filing. Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . .” and specifies factors EPA is to consider in establishing an exemption. III. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. IV. Risk Assessment and Statutory Findings EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers that should present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b). The following exclusion criteria for identifying these low risk polymers are described in 40 CFR 723.250(d). 1. The polymer, 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts, is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. 2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, sodium, and oxygen. 3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii). 4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. 5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. 6. The polymer is not a water absorbing polymer with a number average molecular weight

(MW)greater than or equal to 10,000 daltons. Additionally, the polymer, 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts, also meets as required the following exemption criteria specified in 40 CFR 723.250(e). 7. The polymer's number average MW is greater than or equal to 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000. Thus, 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts meet all the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the above criteria, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts. V. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts is 36,200 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts conform to the criteria that identify a low risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health. VI. Cumulative Effects Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, the Agency consider “available information” concerning the cumulative effects of a particular chemical's residues and “other substances that have a common mechanism of toxicity.” EPA does not have, at this time, available data to determine whether 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts and any other substances and 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative* . VII. Additional Safety Factor for the Protection of Infants and Children Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. VIII. Determination of Safety Based on the conformance to the criteria used to identify a low risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts. IX. Other Considerations A. Endocrine Disruptors There is no available evidence that 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts is an endocrine disruptor. B. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. C. International Tolerances The Agency is not aware of any country requiring a tolerance for 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts nor have any CODEX Maximum Residue Levels

(MRLs)been established for any food crops at this time. X. Conclusion Accordingly, EPA finds that exempting residues of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts from the requirement of a tolerance will be safe. XI. Statutory and Executive Order Reviews This final rule establishes an exemption from the tolerance requirement under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq.* , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. XII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this rule in the **Federal Register** . This rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: February 14, 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: 1 U.S.C. 321(q), 346a and 371. 2. In § 180.960 the table is amended by alphabetically adding a polymer to read as follows: § 180.960 Polymers; exemptions from the requirement of a tolerance. Polymer CAS No. * * * * * 2-Propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts. 886993-11-9 * * * * * [FR Doc. E7-3118 Filed 2-27-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0321; FRL-8115-8] Sethoxydim; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for combined residues of sethoxydim {2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one }and its metabolites containing the 2-cyclohexen-1-one moiety (calculated as sethoxydim) in or on buckwheat grain, buckwheat flour, okra, borage seed, borage meal, fresh dillweed leaves, radish tops, turnip greens, and vegetable, root and tuber, group 1. Interregional Research Project No. 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective February 28, 2007. Objections and requests for hearings must be received on or before April 30, 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-2006-0321. All documents in the docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)305-6463; e-mail address: *Madden.Barbara@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 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . 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* . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at *http://www.epa.gpo/opptsfrs/home/guidelin.htm* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0321 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before April 30, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0321, by one of the following methods: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of July 5, 2006 (71 FR 38154) (FRL-8074-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 0E6204 and 4E6885) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petitions requested that 40 CFR 180.412 be amended by establishing tolerances for combined residues of the herbicide sethoxydim {2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one} and its metabolites containing the 2-cyclohexen-1-one moiety in or on turnip tops at 5.0 parts per million

(ppm)(PP 0E6204) and buckwheat, grain at 20 ppm; buckwheat, flour at 20 ppm; borage; seed at 5.0 ppm; borage, meal at 40 ppm; borage, oil at 40 ppm; dill, fresh leaves at 10 ppm; dill, dried leaves at 10 ppm; okra at 4.0 ppm; vegetable root, except sugar beet, group 1B at 4.0 ppm; and radish tops at 5.0 ppm (4E6885). That notice referenced a summary of the petition prepared by BASF Corporation, the registrant, that is available in EPA's electronic docket. There were no comments received in response to the notice of filing. Upon completing review of the current sethoxydim database, the Agency concluded that the appropriate tolerance levels and preferred commodity terms for sethoxydim residues in or on pending crops should be established as follows: Buckwheat, grain at 19 ppm; buckwheat, flour at 25 ppm; okra at 2.5 ppm; borage, seed at 6.0 ppm; borage, meal at 10 ppm; dillweed, fresh leaves at 10 ppm; radish, tops at 4.5 ppm; turnip, greens at 5.0 ppm and Vegetable, root and tuber, group 1 at 4.0 ppm. Vegetable, root and tuber, group 1 incorporates both the request for vegetable root, except sugar beet, group 1B at 4.0 ppm and existing tolerances for carrot, roots at 1.0 ppm; horseradish at 4.0 ppm; beet, garden at 1.0 ppm; beet, sugar, root at 1.0 ppm; and tuberous and corm vegetable subgroup 1D at 4.0 ppm. Turnip, greens replaces the term turnip tops. In addition, the proposed tolerance for borage oil was withdrawn because no separate tolerance is required since oil is covered by the borage seed tolerance and the proposed tolerance for dill, dried leaves was withdrawn because no separate tolerance is required since dried dillweed is covered by the fresh dillweed tolerance. EPA is also deleting several established tolerances in section 180.412(a) that are no longer needed as a result of this action. The revisions to section 180.412(a) are as follows: Delete beet, garden at 1.0 ppm; beet, sugar, roots at 1.0 ppm; carrot, roots at 1.0 ppm; horseradish at 4.0 ppm; and tuberous and corm vegetable crop subgroup at 4.0 ppm. All of these tolerances are replaced with vegetable, root and tuber, group 1 at 4.0 ppm. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* and *http://www.epa.gov/fedrgstr/EPA-PEST/2003/July/Day-30/p19357.htm.* III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for tolerances for combined residues of sethoxydim and its metabolites containing the 2-cyclohexen-1-one moiety on buckwheat, grain at 19 ppm; buckwheat, flour at 25 ppm; okra at 2.5 ppm; borage, seed at 6.0 ppm; borage, meal at 10 ppm; dillweed, fresh leaves at 10 ppm; radish, tops at 4.5 ppm; turnip, greens at 5.0 ppm and vegetable, root and tuber, group 1 at 4.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. 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 toxic effects caused by sethoxydim as well as the no-observed-adverse-effect-level (the NOAEL) and the lowest-observed-adverse-effect-level (the LOAEL) from the toxicity studies can be found in the final rule published in the **Federal Register** of September 29, 2003 (68 FR 55858) *(http://www.epa.gov/EPA-PEST/2003/September/Day-29/p24562.htm).* B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which the (NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the (LOAEL) of concern are identified is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor

(UF)is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/pesticides/health/human.htm.* A summary of the toxicological endpoints for sethoxydim used for human risk assessment can be found at www.regulations.gov in document 0003 (page 9) in Docket ID EPA-HQ-OPP-2006-0321. To locate this information on the Regulations.gov website follow these steps: Select “Advanced Search”, then “Docket Search.” In the “Keyword” field type the chemical name or insert the applicable “Docket ID number.” (example: EPA-HQ-OPP-2005-9999). Click the “Submit”button. Follow the instructions on the regulations.gov web site to view the index for the docket and access available documents. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Tolerances have been established (40 CFR 180.412) for the combined residues of sethoxydim and its 2-cyclohexen-1-one moiety containing metabolites, in or on a variety of raw agricultural commodities. Tolerances have also been established for combined residues of sethoxydim in or on milk, egg, and fat, meat, and meat byproducts of cattle, goat, hog, horse, poultry and sheep. Risk assessments were conducted by EPA to assess dietary exposures from sethoxydim in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one-day or single exposure. In conducting the acute dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: For all proposed new uses and for all commodities in Vegetable, root and tuber, group 1, tolerance level residues and 100 percent crop treated

(PCT)were assumed. For the remaining crops with existing tolerances available maximum PCT values were used. Tolerance level residues were assumed for most crops except for grapes, oranges, potatoes, tomatoes, strawberries, apples, pears and other pome fruits where anticipated residues were calculated through the incorporation of field trial data. Empirical processing data for apples, grapes, tomatoes, potatoes and oranges were used, and were sometimes translated to other members of the crop group. For livestock commodities, the available PCT information was incorporated into the dietary burden calculation and the feeding studies were used to determine the appropriate residue level, however at least one food item in each diet was assumed to be 100 PCT. PCT information was incorporated into the acute exposure and risk assessments through use of probabilistic risk assessment model. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the DEEM TM software with the Food Commodity Intake Database, which incorporates food consumption data as reported by respondents in the United States Department of Agriculture

(USDA)1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: For the proposed new uses and all commodities in Vegetable, root and tuber, group 1 tolerance level residues and 100% CT were assumed. For most of the crops with existing tolerances, tolerance level residues and average PCT values were assumed. PCT data for some livestock feeds were incorporated into the calculations of the theoretical dietary burdens for livestock, which were then used in conjunction with the available feeding studies to determine the anticipated residues in livestock commodities. iii. *Cancer* . The Agency has classified sethoxydim as not likely to be a human carcinogen based on lack of evidence of carcinogenicity in rats and mice. Therefore, a cancer dietary exposure assessment was not performed iv. *Anticipated residue and PCT information* . Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must pursuant to section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. For the present action, EPA will issue such Data Call-Ins for information relating to anticipated residues as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such Data Call-Ins will be required to be submitted no later than 5 years from the date of issuance of this tolerance. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT. The Agency used PCT information for the chronic dietary risk assessment as follows: 1% apples, 1% apricots, 6% globe artichokes, 5% asparagus, 14% dry beans, 9% lima beans, 8% snap beans, 5% garden beet tops, 1% broccoli, 5% cabbage, 8% cantaloupes, 2% cauliflower, 1% cherries, 2% collards, 1% corn, 1% cotton, 8% cranberries, 6% cucumbers, 5% eggplants, 38% flax, 1% grapes, 1% grapefruits, 5% lemons, 1% lettuce, 1% nectarines, 3% oranges, 2% succulent peas, 14% dry peas, 1% peaches, 5% peanuts, 1% pears, 3% bell peppers, 6% nonbell peppers, 4% potatoes, 8% pumpkins, 4% rapeseed, 6% rhubarb, 2% soybeans, 1% spinach, 8% summer squash, 5% strawberry, 14% sunflower, 4% tomatoes, 5% turnip greens, and 12% watermelons. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available Federal, State, and private market survey data for that use, averaging by year, averaging across all years, and rounding up to the nearest multiple of five percent except for those situations in which the average PCT is less than one. In those cases < 1% is used as the average and < 2.5% is used as the maximum. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the single maximum value reported overall from available federal, state, and private market survey data on the existing use, across all years, and rounded up to the nearest multiple of five percent. In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), Proprietary Market Surveys, and the National Center for Food and Agriculture Policy (NCFAP) for the most recent six years. The Agency believes that the three conditions listed III.C.1.iv. have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which sethoxydim may be applied in a particular area. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for sethoxydim in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of sethoxydim. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm.* Based on the First Index Screening Tool Reservoir (FIRST) and Screening Concentration in Groundwater (SCI-GROW) models, the estimated environmental concentrations

(EECs)of sethoxydim for acute exposures are estimated to be 130 parts per billion

(ppb)for surface water and 1.5 ppb for ground water. The EECs for chronic exposures are estimated to be 16 ppb for surface water and 1.5 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 130 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration value of 16 ppb was used to assess the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Sethoxydim is currently registered for use on the following residential non-dietary sites: Ornamentals and flowering plants, recreational areas, rights-of-way, along fences and hedgerows, and public and commercial buildings/structures (non-agricultural-outdoors). The risk assessment was conducted using the following residential exposure assumptions: Homeowners who apply sethoxydim to ornamental gardens and turf may be exposed for short-term (up to 30 days) durations via the dermal and inhalation routes. Short-term post application exposures to children may result from incidental oral contact via hand-to-mouth, turf-to-mouth, and soil-to-mouth activities with treated turf. No dermal toxicity endpoints were identified, therefore, only exposure from inhalation (adult handlers) and incidental ingestion (children) were assessed. For short-term and intermediate-term aggregate exposure, the inhalation exposures estimated for adult handlers cannot be combined with dietary exposure due to lack of common toxicity via the oral [transitory clinical signs: Irregular gait at doses of 650 milligrams/kilogram (mg/kg) and 1,000 mg/kg and inhalation (hepatotoxicity)] routes of exposure. Therefore, only short-term aggregate exposures from incidental ingestion for children via hand-to-mouth, turf-to-mouth, and soil-to-mouth activities with treated turf were assessed. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to sethoxydim and any other substances and sethoxydim does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that sethoxydim has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . Since there is evidence of increased susceptibility of the young following exposure to sethoxydim in the rat developmental study and the rat reproduction study, the EPA performed a Degree of Concern Analysis to: 1. Determine the level of concern for the effects observed when considered in the context of all available toxicity data; and 2. Identify any residual uncertainties after establishing toxicity endpoints and traditional uncertainty factors to be used in the risk assessment of this chemical. If residual uncertainties are identified, EPA examines whether these residual uncertainties can be addressed by a special FQPA safety factor and, if so, the size of the factor needed. The results of Degree of Concern analysis for sethoxydim are presented as follows: The degree of concern is low for the fetal effects in the developmental rat study since the fetal anomalies were seen only at the high dose (650 mg/kg/day) which is close to the Limit Dose (1,000 mg/kg/day), they were seen in the presence of maternal toxicity (irregular gait) and clear NOAELs/LOAELs were established for maternal and developmental toxicities. EPA has determined that the degree of concern was low for prenatal and/or postnatal toxicity resulting from exposure to sethoxydim toxicity. 3. *Conclusion.* In the final rule published in the **Federal Register** of September 29, 2003 (68 FR 55858) (FRL-7328-6) ( *http://www.epa.gov/EPA-PEST/2003/September/Day-29/p24562.htm* ). EPA retained the additional 10X FQPA safety factor in the form of a Data base Uncertainty Factor because EPA had required submission of subchronic and developmental neurotoxicity studies due to various clinical signs in the rat developmental study and evidence of developmental abnormalities in the rat developmental and reproductive studies. In December of 2004, the EPA revisited the requirement for the subchronic and developmental neurotoxicity studies and determined that the evidence does not support the need for neurotoxicity studies for the reasons discussed below. First, EPA concluded that the clinical signs seen in the rat developmental study were not neurotoxicity. The clinical signs following sethoxydim exposure in that study were irregular gait, decreased activity, excessive salivation, and anogenital staining. These effects were only observed in animals receiving very high doses of sethoxydim (650 mg/kg/day and 1,000 mg/kg/day). Irregular gait was observed in 12/24 dams at 650 mg/kg/day and 10/10 dams at 1,000 mg/kg/day on the first day of dosing, after 3 doses the signs began to dissipate. Decreased activity was noted in 1/34 dams at 650 mg/kg/day and in 4/10 dams at 1,000 mg/kg/day and reversed after several days. Excessive salivation was noted in 23/34 dams at 650 mg/kg/day and 10/10 dams at 1,000 mg/kg/day. Anogenital staining was documented in 13/34 dams at 650 mg/kg/day and 7/10 dams at 1,000 mg/kg/day. All clinical signs reported were transient, with the exception of the anogenital staining which did not reverse. Because the clinical signs occurred shortly after dosing, only occurred at very high treatment doses (over one half the limit dose) and were transitory, it is unlikely that the signs observed are the result of a primary systemic effect on the nervous system but, rather, are reflective of the general toxicity at the high dose. It should be noted that clinical signs indicative of nervous system effects were not observed in any other standard toxicity study for sethoxydim. Although none of these other studies dosed up to 650 and 1,000 mg/kg/day, a maximum tested dose was reached because of evidence of other toxicities (e.g., liver effects or body weight reductions). Second, EPA found that there were no developmental effects seen in the rat and rabbit prenatal studies indicative of an effect on the nervous system. The main effect seen in the rat and rabbit prenatal studies was an increased incidence of fetal skeletal variations due to delayed ossification. In the rat prenatal study, tail abnormalities (filamentous tail or lack of a tail) were noted. These abnormalities were observed at a very low incidence (10 fetuses in 7 litters, 650 milligrams/kilogram/body weight/day (mg/kg/bwt/day and at high treatment doses (650 and 1,000 mg/kg/day). In the 2-generation reproduction study in rat, a tail anomaly (short, thread-like tail, no anal opening, hindlimbs curved toward central midline) was found in one pup in the F2b generation (1/344 total pups; in 1/4 litters). Tail abnormalities are sometimes thought to relate to central nervous system

(CNS)malformations; however, in this case, these tail abnormalities are not likely to be the result of a primary neurotube effect. In the rat prenatal study, there is no description of any effect on neural tube derived structures. Furthermore, the class of compounds, cyclohexones (which sethoxydim is a member), do not demonstrate neurotoxicity or developmental malformations of the nervous system. Therefore, after a weight-of-evidence examination of all the toxicological studies available in the data base, the previous requirement for a neurotoxicity studies have been waived. In light of its finding that neurotoxicity studies are not needed, EPA has now determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: 1. The toxicity database for sethoxydim is complete. 2. There is no indication that sethoxydim is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity. 3. Although there is qualitative evidence of increased susceptibility in the prenatal developmental studies in rats and rabbits, the risk assessment team did not identify any residual uncertainties after establishing toxicity endpoints and traditional uncertainty factors to be used in the risk assessment for sethoxydim. The degree of concern for pre-and/or postnatal toxicity is low. 4. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on tolerance level residues and 100 PCT for all proposed new uses and for all commodities in Vegetable, root and tuber, group 1. For most of the remaining crops available maximum PCT treated values were used for acute dietary assessment and average PCT values were assumed for chronic dietary assessment. Tolerance level residues were assumed for crops with existing tolerances or anticipated residues were calculated through the incorporation of field trial data. Conservative ground and surface water modeling estimates were used. Similarly conservative Residential SOPs were used to assess post-application exposure to children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by sethoxydim. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (“aPAD”) and chronic population adjusted dose (“cPAD”). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (“MOE”) called for by the product of all applicable uncertainty/safety factors is not exceeded. 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to sethoxydim will occupy 11% of the aPAD for the U.S. population, 7.2% of the aPAD for females 13 years and older, 14% of the aPAD for all infants ( < 1 year old), and 20% of the aPAD for children 1-2 years old, the subpopulation at greatest exposure 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to sethoxydim from food and water will utilize 6.9% of the cPAD for the U.S. population, 15% of the cPAD for all infants ( < 1 year old), and 16% of the cPAD for children 1-2 years old, the subpopulation at greatest exposure. Based on the use pattern, chronic residential exposure to residues of sethoxydim is not expected. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Sethoxydim is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for sethoxydim. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food, water and residential exposures aggregated result in aggregate MOEs of 5,700 for children/toddlers 1-2 years of age. Since this is the subpopulation with the highest estimated food and water exposures and the calculated MOE of 5,700 is substantially greater than the target MOE of 100 EPA has no concern for short-term aggregate risk for other subpopulations as well. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Though residential exposure could occur with the use of sethoxydim intermediate-term exposures are not expected. Only risks associated with short-term exposures of up to 30 days were assessed. 5. *Aggregate cancer risk for U.S. population* . The Agency has classified sethoxydim as not likely to be a human carcinogen based on lack of evidence of carcinogenicity in rats and mice. Sethoxydim is not expected to pose a cancer risk. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to sethoxydim residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (gas-liquid chromatography with flame photometric detection in the sulfur mode) is available BASF Wyandotte Corporations'

(BWCs)Method No. 30, 3/15/82; MRID 44864501; Method I, PAM II to enforce the tolerance expression for the purpose of this request. B. International Residue Limits There are currently no Codex maximum residue levels for sethoxydim. V. Conclusion Therefore, the tolerance is established for combined residues of sethoxydim {2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one}and its metabolites containing the 2-cyclohexen-1-one moiety (calculated as sethoxydim), in or on buckwheat, grain at 19 ppm; buckwheat, flour at 25 ppm; okra at 2.5 ppm; borage, seed at 6.0 ppm; borage, meal at 10 ppm; dillweed, fresh leaves at 10 ppm; radish, tops at 4.5 ppm; turnip, greens at 5.0 ppm and vegetable, root and tuber, group 1 at 4.0 ppm. 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

(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: February 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 180.412 is amended in paragraph (a), in the table, by removing the commodities “Beet, garden”, “Beet, sugar, roots”, “Carrot, roots” “Horseradish”, and “Tuberous and corm vegetable crop subgroup”; and alphabetically adding commodities to read as follows: §180.412 Sethoxydim: Tolerances for residues.

(a)* * * Commodity Parts per million * * * * * Borage, meal 10 Borage, seed 6.0 Buckwheat, flour 25 Buckwheat, grain 19 * * * * * Dillweed, fresh leaves 10 * * * * * Okra 2.5 * * * * * Radish, tops 4.5 * * * * * Turnip, greens 5.0 * * * * * Vegetable, root and tuber, group 1 4.0 [FR Doc. E7-3010 Filed 2-27-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0205; FRL-8113-8] Halosulfuron-methyl; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of halosulfuron-methyl in or on the commodities alfalfa, forage at 1.0 parts per million

(ppm)and alfalfa, hay at 2.0 ppm. Gowan Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). The Agency is also correcting the tolerance expression for 40 CFR 180.479(a)(1) with this regulation. The tolerance expression is being corrected because the metabolites were inadvertently deleted from the most recent edition of 40 CFR 180.479. DATES: This regulation is effective February 28, 2007. Objections and requests for hearings must be received on or before April 30, 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-2006-0205. 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: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . 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 FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0205 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before April 30, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0205, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of December 20, 2006 (71 FR 76321) (FRL-8104-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2F2469) by Gowan Company, P. O. Box 5569, Yuma, AZ 85366. The petition requested that 40 CFR 180.479(a)(2) be amended by establishing a tolerance for residues of the herbicide halosulfuron methyl, methyl 5-[(4, 6-dimethoxy-2-pyrimidinyl)amino] carbonylaminosulfonyl-3-chloro-1-methyl-1 *H* -pyrazole-4-carboxylate in or on the raw agricultural commodities alfalfa, forage at 1.0 ppm and alfalfa, hay at 2.0 ppm. The Agency also proposed that the tolerance expression for 40 CFR 180.479(a)(1) be corrected to read “Tolerances are established for residues of the herbicide halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidiny)amino] carbonylaminosulfonyl-3-chloro-1-methyl-1 *H* -pyrazole-4-caboxylate, and its metabolites determined as 3-chloro-1-methyl-5-sulfamoylpyrazole-4-carboxylic acid, expressed as halosulfuron-methyl equivalents in or on the raw agricultural commodities listed in the table in this unit.” That notice referenced a summary of the petition prepared by Gowan Company, the registrant that has been included in the public docket. There were no comments received in response to the notice of filing. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of halosulfuron-methyl the commodities alfalfa, forage at 1.0 ppm and alfalfa, hay at 2.0 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 toxic effects caused by halosulfuron-methyl as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.regulations.gov* in document 0002 (pages 16-20) in docket ID number EPA-HQ-OPP-2006-0205. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the LOAEL is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor

(UF)is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/pesticides/health/human.htm* . A summary of the toxicological endpoints for halosulfuron-methyl used for human risk assessment can be found at *http://www.regulations.gov* . in document 0002 (pages 34-35) in docket ID number EPA-HQ-OPP-2006-0205. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Tolerances have been established (40 CFR 180.479) for the residues of halosulfuron-methyl, in or on a variety of raw agricultural commodities. Tolerances have been established for halosulfuron-methyl and its metabolites determined as 3-chlore-1-methyl-5-sulfamoylpyrazole-4-carboxylic acid, expressed as halosulfuron-methyl equivalents in or on meat by products of cattle, goat, hog, horse, and sheep. Risk assessments were conducted by EPA to assess dietary exposures from halosulfuron-methyl 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 conducting the acute dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the U.S. Department of Agriculture

(PCT)for all existing and proposed uses. Percent crop treated or anticipated residues were not used. The acute dietary exposure estimates are provided for females 13-50 years old only. The existing data showed no indication that halosulfuron-methyl could cause adverse effects in the general population based upon a single dose. Thus there is no concern for acute dietary exposure to the general population. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the DEEM-FCID TM , which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide CSFII, and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A chronic dietary analysis for halosulfuron-methyl was conducted using tolerance level residues and 100 PCT for all existing and proposed uses. Percent crop treated or anticipated residues were not used. iii. *Cancer* . Halosulfuron-methyl is classified as a “not likely” human carcinogen based on a lack of evidence of carcinogenicity in male and female mice and rats following long-term dietary administration. Therefore, halosulfuron-methyl is not expected to pose a cancer risk for humans. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for halosulfuron-methyl in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of halosulfuron-methyl. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index* . Based on the FQPA Index Reservoir Screening Tool (FIRST) and screening concentration in ground water (SCI-GROW) models, the estimated environmental concentrations

(EECs)of halosulfuron-methyl for acute exposures are estimated to be 105 parts per billion

(ppb)for surface water and 0.065 ppb for ground water. The EECs for chronic exposures are estimated to be 105 ppb for surface water and 0.065 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model (DEEM-FCID). For acute and chronic dietary risk assessment, the annual average concentration of 105 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). Halosulfuron-methyl is currently registered for use on the following residential non-dietary sites: Application to commercial and residential turf and on other non-crop sites including airports, cemeteries, fallow areas, golf courses, landscaped areas, public recreation areas, residential property, roadsides, school grounds, sod or turf seed farms, sports fields, and landscaped areas with established woody ornamentals. Application may be by commercial applicator or homeowner. Residential handlers may receive short-term dermal and inhalation exposure to halosulfuron-methyl when mixing, loading, and applying the formulations. Adults and children may be exposed to halosulfuron-methyl residues through dermal contact with turf during postapplicaton activities. A residential exposure and risk assessment was previously conducted for these exposure scenarios. Combined margins of exposure

(MOEs)for adults' and children's dermal exposure and toddlers' incidental exposure from all residential activities are greater than the Agency's LOC of 100, and therefore are not of concern. These risk assessments are fully discussed in Unit III.E.3. of a final rule published in the **Federal Register** of September 20, 2002 (67 FR 59182) (FRL-7200-8). 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 halosulfuron-methyl and any other substances and halosulfuron-methyl 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 halosulfuron-methyl has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor

(SF)value based on the use of traditional UFs and/or special FQPA SFs, as appropriate. 2. *Prenatal and postnatal sensitivity* . There is no evidence of increased susceptibility of young rats in the reproduction study with halosulfuron-methyl. Although there is qualitative evidence of increased susceptibility in the prenatal developmental studies in rats and rabbits, the Agency did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of halosulfuron-methyl. 3. *Conclusion* . EPA determined that the 10X SF to protect infants and children should be removed. The FQPA factor is reduced to 1X based on the following findings. i. The toxicity database for halosulfuron-methyl is complete. Although EPA previously required submission of a developmental neurotoxicity, that requirement has been waived based on a review of the entire database including recently submitted acute and subchronic neurotoxicity studies. This review showed that there was no evidence of clinical signs of neurotoxicity, brain weights changes, or neuropathology in the subchronic (including the neurotoxicity study) or chronic studies in rats, mice, or dogs. The acute neurotoxicity study showed some minor, transient functional observational battery

(FOB)effects on day 0 (none statistically significant) at the limit dose with no effects persisting past day 0. There were not effects on brain weights or neuropathology. The observed FOB effects are not considered attributable to a direct neurotoxic response as they are minor, transient and occurred at the limit dose. ii. There is no evidence of increased susceptibility of young rats in the reproduction study with halosulfuron-methyl. Although there is qualitative evidence of increased susceptibility in the prenatal developmental studies in rats and rabbits, the Agency did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of halosulfuron-methyl. The degree of concern for pre and/or postnatal toxicity is low. iii. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance level residues. Conservative ground water and surface water modeling estimates were used in the risk assessments. Agency Residential standard operational proceedures

(SOPs)are 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 halosulfuron-methyl. E. Aggregate Risks and Determination of Safety 1. *Acute risk* . The acute aggregate risk assessment is provided for females 13-50 years old only. The existing data showed no indication that halosulfuron-methyl could cause adverse effects in the general population based upon a single dose. Thus there is no concern for acute dietary exposure to the general population. Using the exposure assumptions discussed in this Unit III.C. for acute exposure, the acute dietary exposure from food and water to halosulfuron-methy will occupy 1.0% of the acute Population Adjusted Dose

(aPAD)for females 13 years and older. EPA does not expect the acute aggregate exposure to exceed 100% of the aPAD. 2. *Chronic risk* . Using the exposure assumptions described in Unit III.C. for chronic exposure, EPA has concluded that exposure to halosulfuron-methyl from food and water will utilize 3.0% of the chronic Population Adjusted Dose

(cPAD)for the U.S. population, 8.0 of the cPAD for all infants (<1 year old), and 4.0% of the cPAD for children 1-2 years old and children 3-5 years old. Based the use pattern, chronic residential exposure to residues of halosulfuron-methyl is not expected. EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 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). Halosulfuron-methyl is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for halosulfuron-methyl. A short-term risk assessment is required for adults because there is a residential handler exposure scenario. In addition, a short-term risk assessment is required for infants and children because there is a residential post-application exposure scenario for infants and children. Using the exposure assumptions described in Unit III.C. for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs ranging from 2,400 to 4,400. The MOE for the U.S. population is 4,300. The most highly exposed subgroup was all infants (less than 1 year old with an MOE of 2,400. These aggregate MOEs do not exceed the Agency's LOC for aggregate exposure to food and residential uses. EPA does not expect short-term aggregate exposure to exceed the Agency's LOC. 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). Halosulfuron-methyl is currently registered for use(s) 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 exposures for halosulfuron methyl. An intermediate-term risk assessment is required for adults because there is a residential handler exposure scenario. In addition, an intermediate-term risk assessment is required for infants and children because there is a residential post-application exposure scenario for infants and children. As an additional protective measure, residential handler exposures were included in the intermediate-term aggregate risk assessment, although residential exposure over the intermediate-term (more than 30 days) is unlikely. Using the exposure assumptions described is Unit III.E. for intermediate-term exposures; EPA has concluded that food and residential exposures aggregated result in aggregate MOEs ranged from 480 to 560. The MOEs for the U.S. population is 480. The most highly exposed children's subgroup was all infants (less than 1 year old) with a MOE of 560. These aggregate MOEs do not exceed the Agency's LOC for aggregate exposure to food and residential uses. EPA does not expect intermediate-term aggregate exposure to exceed the Agency's LOC. 5. *Aggregate cancer risk for U.S. population* . Halosulfuron-methyl is classified as “not likely to be carcinogenic to humans” based on the lack of evidence for carcinogenicity in mice and rats following long-term dietary administration. Therefore halosulfuron-methyl 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 and to infants and children from aggregate exposure to halosulfuron-methyl residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (gas chromatography with a nitrogen specific detector) 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 currently no established Codex, Canadian, or Mexican maximum residue levels

(MRLs)for halosulfuron-methyl in or on alfalfa, forage or alfalfa, hay. International harmonization is therefore not an issue. V. Conclusion Therefore, the tolerance is established for residues of halosulfuron methyl, methyl 5-[(4, 6-dimethoxy-2-pyrimidinyl)amino] carbonylaminosulfonyl-3-chloro-1-methyl-1 *H* -pyrazole-4-carboxylate in or on the raw agricultural commodities alfalfa, forage at 1.0 ppm and alfalfa, hay at 2.0 ppm (40 CFR 180.479(a)(2)). The Agency is also correcting the tolerance expression for 40 CFR 180.479(a)(1) to read “Tolerances are established for residues of the herbicide halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidiny)amino] carbonylaminosulfonyl-3-chloro-1-methyl-1 *H* -pyrazole-4-caboxylate, and its metabolites determined as 3-chloro-1-methyl-5-sulfamoylpyrazole-4-carboxylic acid, expressed as halosulfuron-methyl equivalent, in or on the raw agricultural commodities listed in the table in this unit.” 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

(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. 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: February 14, 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 180.479 is amended by revising the introductory text of paragraph (a)(1) and alphabetically adding commodities to the table in paragraph (a)(2) to read as follows: §180.479 Halosulfuron-methyl; tolerances for residues.

(a)*General* .

(1)Tolerances are established for residues of the herbicide halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidiny)amino] carbonylaminosulfonyl-3-chloro-1-methyl-1 *H* -pyrazole-4-caboxylate, and its metabolites determined as 3-chloro-1-methyl-5-sulfamoylpyrazole-4-carboxylic acid, expressed as halosulfuron-methyl equivalent in or on the raw agricultural commodities listed in the table in this unit.

(2)* * * Commodity Parts per million Alfalfa, forage 1.0 Alfalfa, hay 2.0 * * * * * [FR Doc. E7-3205 Filed 2-27-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0010; FRL-8113-4] Orthosulfamuron; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a tolerance for residues of orthosulfamuron in or on rice, grain and rice, straw at 0.05 parts per million (ppm). ISAGRO S.p.A., Centro Uffici S. Siro — Fabbricato D — ALA 3, Via Caldera, 21, 20153 Milano, Italy, requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective February 28, 2007. Objections and requests for hearings must be received on or before April 30, 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-2007-0010. 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: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . 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 FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-0010 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before April 30, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2007-0010, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of July 27, 2005 (70 FR 43421) (FRL-7727-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5F 6957) by ISAGRO S.p.A., Centro Uffici S. Siro — Fabbricato D — ALA 3, Via Caldera, 21, 20153 Milano, Italy. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of the herbicide orthosulfamuron in or on rice, grain and rice, straw at 0.05 ppm. That notice referenced a summary of the petition prepared by ISAGRO S.p.A., Centro Uffici S. Siro — Fabbricato D — ALA 3, Via Caldera, 21, 20153 Milano, Italy, the registrant, that is included in the public docket. There were no comments received in response to the notice of filing. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of orthosulfamuron in or on rice, grain and rice, straw at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. 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 toxic effects caused by orthosulfamuron as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.regulations.gov* in document 0002 (pages 38-44) in docket ID number EPA-HQ-OPP-2007-0010. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor

(USDA)1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The chronic analysis is based on tolerance level residues and 100% of the crop treated. iii. *Cancer* . Orthosulfamuron is classified as demonstrating “suggestive evidence of carcinogenicity” based on thyroid follicular cell adenomas observed in male rats. The Agency has concluded that quantification of human cancer risk is not warranted and the NOAEL selected for the chronic reference dose

(cRfD)is protective of cancer effects. iv. *Anticipated residue and percent crop treated

(PCT)information* . The chronic dietary exposure analysis was based on tolerance level residues and 100 PCT assumptions. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for orthosulfamuron in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of orthosulfamuron. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://docket.epa.gov/edkpub/index.jsp* Based on the interim rice model and screening concentration in groundwater (SCI-GROW) models, the estimated environmental concentration

(EECs)of orthosulfamuron in drinking water for chronic exposures is estimated to be 40.5 parts per billion

(ppb)for surface water and 0.611 ppb for groundwater. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Orthosulfamuron is not registered for use on any sites that would result in residential exposure. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to orthosulfamuron and any other substances and orthosulfamuron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that orthosulfamuron has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . There is no concern for increased quantitative and/or qualitative susceptibility after exposure to orthosulfamuron in developmental toxicity studies in rats and rabbits, or a reproduction study in rats. In the developmental studies, there was no treatment-related maternal or developmental toxicity observed. In the reproduction study, decreased motor activity was seen in 6-week old males

(F1)at 354.5 milligrams/kilograms/day (mg/kg/day). However, the offspring effects were observed in the presence of maternal toxicity (kidney lesions), seen in adult females of both generations (F0 and F1). The NOAEL (5 mg/kg/day) selected for the cRfD is lower

(70X)than the dose at which the motor activity was observed and; thus, considered protective of the effects. 3. *Conclusion* . EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. The toxicity database for orthosulfamuron is complete. ii. There is no indication that orthosulfamuron is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that orthosulfamuron results in increased susceptibility in *in utero* rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. Conservative groundwater and surface water modeling estimates were used. Similarly conservative. These assessments will not underestimate the exposure and risks posed by orthosulfamuron. E. Aggregate Risks and Determination of Safety 1. *Acute risk* . Review of applicable toxicity studies indicated that orthosulfamuron is not expected to pose an acute risk. 2. *Short-term risk* . Orthosulfamuron is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC. 3. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be background exposure level). Orthosulfamuron is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC. 4. *Chronic risk* . EPA considers chronic aggregate risk to consist of risks resulting from exposure to residues in food, drinking water, and residues resulting from residential applications. As there are no residential uses for orthosulfamuron, chronic aggregate risk consists of risks resulting from exposure to residues in food and drinking water alone, which do not exceed the Agency's LOC. 5. *Aggregate cancer risk for U.S. population* . The long-term chronic risk assessment outlined in this unit is considered to be protective of cancer effects. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to orthosulfamuron residues. IV. Other Considerations A. Analytical Enforcement Methodology An adequate high performance liquid chromatography-mass spectrometry analytical method for enforcement purposes is available. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft Meade, Maryland 20755-5350. Telephone number:

(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits No Codex maximum residue limits

(MRLs)have been established for residues of orthosulfamuron on any crops at this time. V. Conclusion Therefore, the tolerance is established for residues of orthosulfamuron, in or on rice, grain and rice, straw at 0.05 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

(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(a)*General* . Tolerances are established for residues of orthosulfamuron 1-(4,6-dimethoxypyrimidin-2-yl)-3-[2-(dimethylcarbamoyl)- phenylsulfamoyl] urea) *per se* in or on the following commodities: Commodity Parts per million Rice, grain 0.05 Rice, straw 0.05

(b)*Section 18 emergency exemptions* . [Reserved]

(c)*Tolerances with regional registrations* . [Reserved]

(d)*Indirect and inadvertant residues* . [Reserved] [FR Doc. 07-898 Filed 2-23-07; 2:13 pm]

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