On November 4, 2004, GIPSA issued a Federal Register notice (69 FR 64269-64270), announcing an intent to implement barley protein measurement as official criteria under the United States Grain Standards Act (USGSA) effective July 1, 2005. The Federal Register notice is available on the GIPSA Web site at http://www.gipsa.usda.gov.

On November 8, 2006, GIPSA issued a Federal Register interim rule (71 FR 65371-65373) seeking comments on GIPSA's intention to extend its official inspection program to include testing of Barley protein and to establish a fee for such testing. There were no comments received on this request.

This provides the barley industry with accurate results for protein that the market can rely on to negotiate price, value, and premium.

GIPSA collects fees for providing official testing services to cover, as nearly as practicable, GIPSA's costs for performing the service, including related administrative and supervisory costs. Testing procedures and time necessary to determine protein in barley using the approved near-infrared transmittance (NIRT) analyzers are the same as those required for NIRT wheat protein; soybean oil and protein; and corn oil, protein, and starch determinations. Accordingly, the fee to test barley is the same as for tests for the above cited commodities. The fee is $2.25 per test when the service is performed at an applicant's facility in an onsite FGIS laboratory, and for services performed at a location other than an applicant's facility in an FGIS laboratory the fees will be $10.00 per test for an original inspection service and $17.70 per test for an appeal inspection service.

Further, since the fees for near-infrared (NIR) analysis are the same as the fees for nuclear magnetic resonance (NMR) analysis, these fees are included in a generic NIR and NMR analysis fee. This should simplify the fee schedule and will not require a regulatory fee change when new NIR and NMR analysis are available for other grain products. Specifically, in 7 CFR 800.71, in tables 1 and 2, we will add a single new fee for “NIR and NMR analysis (protein, oil, starch, etc.)” to replace the individual fees currently listed for the following 4 categories: (1) Corn oil, protein, and starch (one of any combination), (2) soybean protein and oil (one or both), (3) wheat protein (per test), and (4) sunflower (per test). We renumbered the remaining fees listed in table 1, section 2 and table 2, sections 1 and 2. We are not making any other changes to the remaining fee amounts or categories at this time.

We run standard reference samples through the equipment to evaluate the accuracy of the equipment; for barley, the standard reference samples sets typically weigh between 650 and 750 grams. Due to the natural variation in individual kernels of barley and other sources of variability, each time we test the barley the testing equipment is likely to produce slightly different results. Therefore, we determine the allowable amount of differences between the test results from the standard reference sample and the expected outcome. We refer to this amount as the tolerance, which is the variation we allow for the equipment to produce accurate results.

We determined that, based upon the performance of the instruments and calibration, the maintenance tolerance will be ±0.20 percent mean deviation from the national standard NIRS instruments for the NIRS analyzers used in performing official inspections. We determined that this level of accuracy will provide reliable testing procedures and accurate results to meet prospective official customer needs and that the market can rely on to negotiate price, value, and premium. We will apply this tolerance according to testing instructions found in the GIPSA Near-Infrared Transmittance (NIRT) Handbook.

We are adding this tolerance as a new paragraph (b)(4) in 7 CFR 801.7. Previously, 7 CFR 801.7(b) only included tolerances for (1) NIRS wheat protein analyzers, (2) NIRS soybean oil and protein analyzers, and (3) NIRS corn oil, protein, and starch analyzers. As with other commodities for which NIRS analyzers are used, we will use the chemical reference protein determinations to reference and calibrate official NIRS instruments in accordance with the Combustion Method, AOAC International Method 992.23, which we previously incorporated by reference into 7 CFR 801.7(b). No change to the incorporation is required for barley protein testing.

This final rule has been determined to be not significant for purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget (OMB).

The Administrator of GIPSA has determined that this rule will not have a significant impact on a substantial number of small entities as defined in the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ).

Currently, near-infrared spectroscopy analyzers are being used to determine wheat protein; soybean oil and protein; and corn oil, protein, and starch in both domestic and export markets. This rule establishes tolerances to expand the use of currently approved near-infrared spectroscopy analyzers to test barley protein and establishes a generic fee for all NIR and NMR testing that is identical to current fees. Testing for barley protein is included in this fee. There are 58 official agencies (46 private entities, 12 States) that are designated and/or delegated by GIPSA to perform official grain inspection services. Most of the agencies could be considered small entities under Small Business Administration criteria.

The extent to which these agencies will choose to provide this service is difficult to quantify because GIPSA is offering this service on a request basis, and locations where service is requested infrequently may make arrangements with neighboring agencies to provide the service (7 CFR 800.196(g)(1)). GIPSA believes that offering this service would have a beneficial effect on those agencies electing to provide the service.

For the 2006/2007 Market Year (June to May), USDA's Economic Research Service estimated the U.S. Barley Supply to be 303,000,000 bushels. Between June 2006 and September 2006 (the months for which we have data), 20,010,000 bushels of barley were tested for protein. Ten of the 58 official agencies, performed barley protein tests in the first 11 months of fiscal year 2006. There were 5,176 barley protein tests performed; of those 2,624 were tests performed for trucks and rail cars, 2,546 were tests performed on submitted samples, and 6 were performed locally, such as within a grain elevator.

According to USDA's National Agricultural Statistics Service, there are 24,747 farms (producers) in the barley for grain category. We do not have estimates for the number of grain handlers, exporters, and feedlot operators that may be involved in submitting barley for protein testing. In general, many producers, grain handlers, exporters, and feedlot operators may be considered small entities under Small Business Administration criteria. Further, grain handlers and exporters often use testing results to determine value and premiums. The extent to which these entities will request the official barley protein or the impact of offering this service is difficult to quantify. GIPSA believes that barley producers, feedlot operators, grain handlers, and exporters will rely on the official system to provide reliable testing procedures and accurate results that the market can rely on to negotiate price, value, and premiums.

Fees currently are charged for NIR testing. The fees charged by GIPSA are $2.25 per test when the service is performed at an applicant's facility in an onsite FGIS laboratory, and when an inspection service is performed at a location other than an applicant's facility in an FGIS laboratory the fees are $10.00 per test for an original inspection service and $17.70 for an appeal inspection service. The generic fee is the same as fees charged for current individual tests and their impact on applicants for services will vary depending upon usage since these tests are on a request basis.

Executive Order 12988, Civil Justice Reform, instructs each executive agency to adhere to certain requirements in the development of new and revised regulations in order to avoid unduly burdening the court system. This final rule has been reviewed under this Executive Order. This final rule is not intended to have a retroactive effect. The United States Grain Standards Act provides in Section 87g that no State or subdivision may require or impose any requirements or restrictions concerning the inspection, weighing, or description of grain under the Act. Otherwise, this final rule will not preempt any State or local laws, regulations, or policies unless they present irreconcilable conflict with this rule. There are no administrative procedures which must be exhausted prior to any judicial challenge to the provisions of this interim rule.

In accordance with the Paperwork Reduction Act of 1995, the recordkeeping and reporting burden imposed by parts 800 and 801 were previously approved by OMB under control number 0580-0013 and will not be affected by this rule.

GIPSA is committed to compliance with the Government Paperwork Elimination Act, which requires Government agencies, in general, to provide the public the option of submitting information or transacting business electronically to the maximum extent possible.

Background

Certain individuals employed by licensees or contractors of the NRC are assigned duties which require access to special nuclear material (plutonium, uranium-233, and uranium enriched in the isotopes uranium-233 or uranium-235) or to restricted data or national security information. Individuals who require access to this material or information must obtain an access authorization from the NRC. When a licensee requests access authorization for an employee or a contractor, the NRC initiates a background investigation of the individual seeking access authorization. Based on the results of that investigation, the NRC will determine whether permitting the individual access to special nuclear material, restricted data, or national security information would create a security risk.

OPM conducts the required access authorization background investigations for the NRC and sets the rates charged for these investigations. The combined cost of the OPM background investigation and any related NRC processing activities are recovered from the licensee through an access authorization fee assessed by the NRC. It is the NRC's practice to publish the fee schedule for special nuclear material access authorization in 10 CFR 11.15(e)(1) and the corresponding fee schedule for restricted data and national security information access authorization in Appendix A to 10 CFR part 25. Both schedules are based on rates charged by OPM for conducting the required background investigations.

This final rule amends §§ 11.15(e) and 25.17(f), and Appendix A to part 25 by modifying the fee charged to licensees for work performed under the MAAP and IAAP from 11.6 percent of the OPM billing rates to 31.7 percent. This modification will ensure that the NRC's administrative costs are fully recovered through access authorization fees charged to licensees.

This final rule will continue to allow licensees to calculate the NRC fee for any given application by reference to the current OPM billing schedule for personnel investigation services. Investigations Reimbursable Billing Rates for personnel background checks are published by OPM's Investigations Service in a Federal Investigation Notice (FIN). The current OPM billing rates were published as FIN 06-08 on September 11, 2006, and became effective on October 1, 2006. FIN 06-08 is available on OPM's Investigations Service Web site at http://www.opm.gov/extra/investigate/fins.htm . NRC licensees can also obtain the current OPM investigations rate schedule from the Personnel Security Branch of the NRC's Division of Facilities and Security by contacting the individual named under the FOR FURTHER INFORMATION CONTACT heading.

The amendments specify the NRC's access authorization fee for any given request as the sum of the current OPM billing rate for the required investigation, and the NRC's in-house processing fee. As noted previously, the OPM billing rate is pulled directly from the current OPM fee schedule for investigations. The tables in § 11.15(e)(2) and Appendix A to part 25 cross-reference each type of NRC access authorization request to the appropriate investigation service listed in OPM's fee schedule. The NRC's in-house processing fee is 31.7 percent of the relevant OPM rate. The in-house processing fee of 31.7 percent is based on a recent NRC audit of actual in-house costs incurred in processing licensee applications for access authorization. This fixed percentage of the OPM rate, when added to the base OPM investigations charge, yields the total access authorization fee assessed by the NRC {OPM rate + [(OPM rate × 31.7%), rounded to the nearest dollar] = NRC access authorization fee}.

For example, a licensee seeking a special nuclear material “NRC-U” access authorization requiring a single scope background investigation is directed by the table in § 11.15(e)(2) to calculate the application fee based on the OPM billing rate for a “Code C” Single Scope Background Investigation (SSBI). According to the current OPM investigations fee schedule (FIN 06-08), OPM charges $3,550 for a “Code C” SSBI. The table instructs the licensee to calculate the NRC processing fee by multiplying $3,550 by 31.7 percent, which equals $1,125.35. The licensee then rounds the NRC processing fee to the nearest dollar, or $1,125, and adds that amount to the OPM investigations fee of $3,550 to determine the total assessed material access authorization fee: $4,675. The following table illustrates the calculation process:

Licensees applying for restricted data or national security information access authorization follow a similar procedure. The table in Appendix A to part 25 cross-references each type of “Q” or “L” access authorization to the corresponding OPM investigation type. The OPM billing rate for the type of investigation referenced is determined by consulting the current OPM schedule of billing rates. This rate is then plugged into the fee assessment formula {OPM rate + [(OPM rate × 31.7%), rounded to the nearest dollar] = NRC access authorization fee}, illustrated previously, to calculate the correct NRC access authorization fee for the type of application submitted.

Section 11.15(e)(1) describes how the OPM bills the NRC for the cost of each background investigation of a given type and provides the formula used in calculating the material access authorization fee. The percentage of the OPM billing rates in this formula is being changed from 11.6% of the OPM billing rate to 31.7% of that rate. This section also explains how to access the OPM billing schedule and specifies that any changes to the NRC's access authorization fees will be applicable to each access authorization request received on or after the effective date of OPM's most recently published billing schedule.

Section 11.15(e)(2) directs licensees to remit the appropriate access authorization fee with each application submitted, in accordance with the table presented in that section. The table cross-references each type of NRC material access authorization request to a type of investigation in the current OPM fee schedule, and directs licensees to calculate the application fee according to the stated formula {OPM rate + [(OPM rate × 31.7%), rounded to the nearest dollar] = NRC access authorization fee}.

Section 11.15(e)(3) indicates that applications for individuals that have a current access authorization from another Federal agency may be processed expeditiously at no cost to the licensee.

Section 25.17(f)(1) describes how the OPM bills the NRC for the cost of each background investigation and provides the formula used in calculating national security information and restricted data access authorization fees. This section also explains how to access the OPM billing schedule and specifies that any changes to the NRC access authorization fees will be applicable to each access authorization request received on or after the effective date of OPM's most recently published billing schedule.

Section 25.17(f)(2) directs licensees to remit the appropriate national security information or restricted data access authorization fee with each application submitted. Applicants are instructed to calculate the appropriate fee by using the stated formula {OPM rate + [(OPM rate × 31.7%), rounded to the nearest dollar] = NRC access authorization fee} with reference to the table in appendix A to part 25.

Section 25.17(f)(3) indicates that applications for individuals that have a current access authorization from another Federal agency may be processed expeditiously at no cost to the licensee.

The revised table in Appendix A to part 25 cross-references each type of NRC “Q” or “L” access authorization request to a type of investigation in the current OPM fee schedule, and directs licensees to calculate the application fee according to the stated formula.

Because this final rule deals solely with agency practice and procedure, the notice and comment provisions of the Administrative Procedure Act do not apply under 5 U.S.C. 553(b)(A). The final rule is effective 30 days after its publication in the Federal Register .

The National Technology Transfer and Advancement Act of 1995, Public Law 104-113, requires agencies to use technical standards developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or is otherwise impractical. This final rule amends the formula for calculating the NRC access authorization fee charged to licensees for work performed under MAAP and IAAP from 11.6 percent of the OPM billing rate for an investigation of a given type to 31.7 percent.

This action is administrative in nature and does not involve the establishment or application of a technical standard containing generally applicable requirements.

The NRC has determined that this final rule is the type of action described in categorical exclusions 10 CFR 51.22(c)(1) and (2). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this final rule.

This final rule does not contain new or amended information collection requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Existing requirements were approved by the Office of Management and Budget (OMB), approval numbers 3150-0046 and 3150-0062.

If a means used to impose an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to the information collection.

A regulatory analysis has not been prepared for this final rulemaking. This final rule ensures that the NRC recovers the full cost of application processing from licensees submitting access authorization requests. The formula method for calculating these fees continues to provide a more efficient and effective mechanism for updating NRC access authorization fees in response to changes in the underlying OPM rate schedule for required personnel background investigations. These amendments are administrative in nature and will neither impose new nor relax existing safety requirements and, thus, do not call for the sort of safety/cost analysis described in the agency's regulatory analysis guidelines in NUREG/BR-0058.

The NRC has determined that the backfit rule does not apply to this final rule and a backfit analysis is not required because these amendments do not involve any provisions that would impose backfits as defined in 10 CFR Chapter I.

In accordance with the Congressional Review Act, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of OMB.

This amendment to 14 CFR Part 71 modifies the Class E airspace area at Canby, Myers Field, MN. The radius of the Class E airspace area extending upward from 700 feet or more above the surface of the earth is expanded from within a 6.3-mile radius to within a 7.4-mile radius of the airport. An extension is established within 4 miles each side of the 301 bearing from the airport extending from the 7.4-mile radius to 10.3 miles northwest of the airport. This modification brings the legal description of the Canby, Myers Field, MN Class E5 airspace area into compliance with FAA Orders 7400.2F and 8260.19C. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in Paragraph 6005 of FAA Order 7400.9P, Airspace Designations and Reporting Points, dated September 1, 2006, and effective September 15, 2006, which is incorporated by reference in 14 CFR 71.1 of the same order. The Class E airspace designations listed in this document would be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. Unless a written adverse or negative comment or a written notice of intent to submit an adverse or negative comments is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comment, or written notice of intent to submit such comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

Interested parties are invited to participate in this rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in development reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2006-27676/Airspace Docket NO. 07-AGL-2.” The postcard will be date/time stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule doe snot have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority since it contains aircraft executing instrument approach procedures to Canby, Myers Field, MN.

This amendment to 14 CFR part 71 modifies the legal description of Class D airspace and Class E airspace at Manhattan Municipal Airport, KS. The establishment of adjacent Class D airspace at Fort Riley, Marshall Army6 Airfield, KS requires this modification. A reference excluding the Class D airspace at Fort Riley, Marshall Army Airfield, KS is added to those legal descriptions. This modification brings the legal description of the Manhattan Municipal Airport, KS Class D airspace and Class E airspace into compliance with FAA Orders 7400.2F and 8260.19C. Class D airspace areas are published in Paragraph 5000 of FAA Order 7400.9P, Airspace Designations and Reporting Points, dated September 1, 2006, and effective September 15, 2006, which is incorporated by reference in 14 CFR 71.1. Class E airspace designated as surface areas are published in Paragraph 6002 of the same order. The airspace designations listed in this document would be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. Unless a written adverse or negative comment or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

Interested parties are invited to participate in this rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2007-27677/Airspace Docket No. 07-ACE-2.” the postcard will be date/time stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) is not a “significant regulatory action” under Executive Order 12866, (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority since it contains aircraft executing instrument approach procedures to Manhattan Municipal Airport, KS.

This amendment to 14 CFR part 71 modifies the Class E airspace area extending upward from 700 feet AGL (E5) at Monticello Regional Airport, IA. The southeast extension to the E5 airspace area is deleted and the reference to the Monticello NDB is removed from the legal description. This modification brings the legal description of the Monticello Regional Airport, IA Class E5 airspace area into compliance with FAA Orders 7400.2F and 8260.19C. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in Paragraph 6005 of FAA Order 7400.9P, Airspace Designations and Reporting Points, dated September 1, 2006, and effective September 15, 2006, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document would be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. Unless a written adverse or negative comment or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

Interested parties are invited to participate in this rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in development reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2007-27678/Airspace Docket No. 07-ACE-3.” The postcard will be date/time stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) is not a ``significant regulatory action'' under Executive Order 12866; (2) is not a ``significant rule'' under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority since it contains aircraft executing instrument approach procedures to Monticello Regional Airport, IA.

This amendment to 14 CFR part 71 modifies the Class E airspace area extending upward from 700 feet above the surface (E5) at Marshalltown Municipal Airport, IA. The northwest extension of the E5 airspace area is defined by the 298° radial from the Elmwood VOR/DME instead of the NDB and the southeast extension is changed from the 135° radial from the Elmwood VOR/DME to the 138° radial to match Instrument Approach Procedures. The reference to the Marshalltown NDB is removed from the legal description. This modification brings the legal description of the Marshalltown Municipal Airport, IA Class E5 airspace area into compliance with FAA Orders 7400.2F and 8260.19C. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in Paragraph 6005 of FAA Order 7400.9P, Airspace Designations and Reporting Points, dated September 1, 2006, and effective September 15, 2006, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document would be published subsequently in the Order

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. Unless a written adverse or negative comment or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document witdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

Interested parties are invited to participate in this rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: ``Comments to Docket No. FAA-2007-27679/Airspace Docket No. 07-ACE-4.'' The postcard will be date/time stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) is not a ``significant regulatory action'' under Executive Order 12866; (2) is not a ``significant rule'' under the Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority since it contains aircraft executing instrument approach procedures to Marshalltown Municipal Airport, IA.

This amendment to 14 CFR part 71 modifies the Class E airspace area at Canby, Myers Field, MN. The radius of the Class E airspace area extending upward from 700 feet or more above the surface of the earth is expanded from within a 6.3-mile radius to within a 7.4-mile radius of the airport. An extension is established within 4 miles each side of the 301 bearing from the airport extending from the 7.4-mile radius to 10.3 miles northwest of the airport. This modification brings the legal description of the Canby, Myers Field, MN Class E5 airspace area into compliance with FAA Orders 7400.2F and 8260.19C. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in Paragraph 6005 of FAA Order 7400.9P, Airspace Designations and Reporting Points, dated September 1, 2006, and effective September 15, 2006, which is incorporated by reference in 14 CFR 71.1 of the same order. The Class E airspace designations listed in this document would be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. Unless a written adverse or negative comment or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comments, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

Interested parties are invited to participate in this rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2006-27676/Airspace Docket No. 07-AGL-2.” The postcard will be date/time stamped and returned to the commenter.

The regulation adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is noncontroversial and unlikely to result in adverse or negative comments. For the reason discussed in the preamble, I certify that this regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority since it contains aircraft executing instrument approach procedures to Canby, Myers Field, MN.

This amendment to 14 CFR part 71 modifies the legal description of Class D airspace and Class E airspace at Manhattan Municipal Airport, KS. The establishment of adjacent Class D airspace at Fort Riley, Marshall Army Airfield, KS requires this modification. A reference excluding the Class D airspace at Fort Riley, Marshal Army Airfield, KS is added to those legal descriptions. This modification brings the legal description of the Manhattan Municipal Airport, KS Class D airspace and Class E airspace into compliance with FAA Orders 7400.2F and 8260.19C. Class D airspace areas are published in Paragraph 5000 of FAA Order 7400.9P, Airspace Designations and Reporting Points, dated September 1, 2006, and effective September 15, 2006, which is incorporated by reference in 14 CFR 71.1. Class E airspace designated as surface areas are published in Paragraph 6002 of the same order. The airspace designations listed in this document would be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. Unless a written adverse or negative comment or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

Interested parties are invited to participate in this rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2007-27677/Airspace Docket No. 07-ACE-2.” The postcard will be date/time stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority since it contains aircraft executing instrument approach procedures to Manhattan Municipal Airport, KS.

This amendment to 14 CFR part 71 modifies the Class E airspace area extending upward from 700 feet above the surface (E5) at Marshalltown Municipal Airport, IA. The northwest extension of the E5 airspace area is defined by the 298° radial from the Elmwood VOR/DME instead of the NDB and the southeast extension is changed from the 135° radial from the Elmwood VOR/DME to the 138° radial to match Instrument Approach Procedures. The reference to the Marshalltown NDB is removed from the legal description. This modification brings the legal description of the Marshalltown Municipal Airport, IA Class E5 airspace area into compliance with FAA Orders 7400.2F and 8260.19C. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in Paragraph 6005 of FAA Order 7400.9P, Airspace Designations and Reporting Points, dated September 1, 2006, and effective September 15, 2006, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document would be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. Unless a written adverse or negative comment or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

Interested parties are invited to participate in this rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2007-27679/Airspace Docket No. 07-ACE-4.” The postcard will be date/time stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority since it contains aircraft executing instrument approach procedures to Marshalltown Municipal Airport, IA.

This amendment to 14 CFR part 71 modifies the Class E airspace area extending upward from 700 feet AGL (E5) at Monticello Regional Airport, IA. The southeast extension to the E5 airspace area is deleted and the reference to the Monticello NDB is removed from the legal description. This modification brings the legal description of the Monticello Regional Airport, IA Class E5 airspace area into compliance with FAA Orders 7400.2F and 8260.19C. Class E airspace area extending upward from 700 feet or more above the surface of the earth are published in Paragraph 6005 of FAA Order 7400.9P, Airspace Designations and Reporting Points, dated September 1, 2006, and effective September 15, 2006, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document would be published subsequently in the Order.

The FAA anticipates that this regulation will not result in adverse or negative comment and, therefore, is issuing it as a direct final rule. Previous actions of this nature have not been controversial and have not resulted in adverse comments or objections. Unless a written adverse or negative comment or a written notice of intent to submit an adverse or negative comment is received within the comment period, the regulation will become effective on the date specified above. After the close of the comment period, the FAA will publish a document in the Federal Register indicating that no adverse or negative comments were received and confirming the date on which the final rule will become effective. If the FAA does receive, within the comment period, an adverse or negative comment, or written notice of intent to submit such a comment, a document withdrawing the direct final rule will be published in the Federal Register , and a notice of proposed rulemaking may be published with a new comment period.

Interested parties are invited to participate in this rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2007-27678/Airspace Docket No. 07-ACE-3.” The postcard will be date/time stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is noncontroversial and unlikely to result in adverse or negative comments. For the reasons discussed in the preamble, I certify that this regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority since it contains aircraft executing instrument approach procedures to Monticello Regional Airport, IA.

This amendment to Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), establishes, amends, suspends, or revokes SIAPs and/or Weather Takeoff Minimums. The complete regulatory description of each SIAP and/or Weather Takeoff Minimums is contained in official FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA Forms are identified as FAA Forms 8260-3, 8260-4, 8260-5 and 8260-15A. Materials incorporated by reference are available for examination or purchase as stated above.

The large number of SIAPs and/or Weather Takeoff Minimums, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs and/or Weather Takeoff Minimums but refer to their depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP and/or Weather Takeoff Minimums contained in FAA form documents is unnecessary. The provisions of this amendment state the affected CFR sections, with the types and effective dates of the SIAPs and/or Weather Takeoff Minimums. This amendment also identifies the airport, its location, the procedure identification and the amendment number.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and/or Weather Takeoff Minimums as contained in the transmittal. Some SIAP and/or Weather Takeoff Minimums amendments may have been previously issued by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP, and/or Weather Takeoff Minimums amendments may require making them effective in less than 30 days. For the remaining SIAPs and/or Weather Takeoff Minimums, an effective date at least 30 days after publication is provided.

Further, the SIAPs and/or Weather Takeoff Minimums contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and/or Weather Takeoff Minimums, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs and/or Weather Takeoff Minimums and safety in air commerce, I find that notice and public procedure before adopting these SIAPs and/or Weather Takeoff Minimums are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs and/or Weather Takeoff Minimums effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Section 207 of the Foster Care Independence Act of 1999 amended title XI of the Social Security Act by adding section 1129A to provide for the imposition of administrative sanctions by SSA against persons who knowingly make a statement that is false or misleading or omits a material fact for use in determining any right to or amount of monthly benefits under titles II or XVI of the Social Security Act.

Section 201 of the SSPA of 2004 amended section 1129A to also allow for the imposition of the administrative sanction against persons who fail to disclose information that is material to eligibility or benefit amount if the person knows or should know that the withholding of such information is misleading. These sanctions are in addition to any other penalties prescribed by law that may result from false/misleading statements or failure to report material facts.

The SSPA provided that this change would only apply with respect to violations committed after the date on which there was a title II and title XVI computerized system in place which would document reporting of monthly wages. The title XVI system became functional on November 27, 2006. The title II system became operational in 2005.

As a result of the implementation of this computerized system on November 27, 2006, the revisions to 20 CFR 404.459 and 419.1340 expanding the situations where administrative sanctions may be imposed became applicable. A person is subject to a sanction for failing to disclose information that is material to determining title II/title XVI benefit eligibility or amounts if:

• The person knows or should know the information is material to benefit eligibility or amount; and

• The person knows or should know the withholding of the information is misleading; and

• The failure to disclose occurred after November 27, 2006.

We have revised our instructional manuals and other documents to reflect this additional instance where administrative sanctions may be imposed.

Section 201(a)(1) of the SSPA, Public Law 108-203, amended section 1129 of the Social Security Act (Act) (42 U.S.C. 1320a-8), to allow for the imposition of civil monetary penalties and/or assessments for the withholding of information from, or failure to disclose information to, SSA.

Pursuant to section 201(d) of the SSPA, this amendment to section 1129 of the Act “shall apply with respect to violations committed after the date on which the Commissioner of Social Security implements the centralized computer file described in section 202” of the SSPA. Section 202 of the SSPA provided for the implementation by the Commissioner of “a centralized computer file recording the date of the submission of information by a disabled beneficiary (or representative) regarding a change in the beneficiary's work or earnings status.”

On May 17, 2006, at 71 FR 28574, the OIG published the final rules reflecting and implementing the amendments to sections 1129 and 1140 of the Social Security Act made by the SSPA and Public Law 106-169, the Foster Care Independence Act of 1999, including section 201(a)(1) of the SSPA. At that time we stated the following regarding the implementation of section 201(a) of the SSPA:

On November 27, 2006, SSA fully implemented the centralized computer file described in section 202 of the SSPA. Therefore, pursuant to the requirements of section 201 of the SSPA and the final rules published at 71 FR 28574, this notice announces that 20 CFR 498.102(a)(3), as it relates to the withholding of information from, or failure to disclose information to, SSA, is applicable to violations committed after November 27, 2006.

Throughout this document, whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

Ground-level ozone is not emitted directly by sources. Rather, emissions of nitrogen oxides (NO X ) and volatile organic compounds (VOCs) react in the presence of sunlight to form ground-level ozone. NO X and VOCs are referred to as precursors of ozone.

The CAA establishes a process for air quality management through the NAAQS. Before promulgation of the current 8-hour standard, the ozone NAAQS was based on a 1-hour standard. At the time EPA revoked the 1-hour ozone NAAQS, on June 15, 2005, the Flint, Grand Rapids, Kalamazoo-Battle Creek, Lansing-East Lansing, Muskegon, Benton Harbor, Benzie County, Cass County, Huron County, and Mason County areas were all designated as attainment under the 1-hour ozone NAAQS.

On July 18, 1997, EPA promulgated a revised 8-hour ozone standard of 0.08 parts per million (ppm). This new standard is more stringent than the previous 1-hour standard. On April 30, 2004 (69 FR 23857), EPA published a final rule designating and classifying areas under the 8-hour ozone NAAQS. These designations and classifications became effective June 15, 2004. The CAA required EPA to designate as nonattainment any area that was violating the 8-hour ozone NAAQS based on the three most recent years of air quality data, 2001-2003.

The CAA contains two sets of provisions, subpart 1 and subpart 2, that address planning and control requirements for nonattainment areas. (Both are found in title I, part D, 42 U.S.C. 7501-7509a and 7511-7511f, respectively.) Subpart 1 (which EPA refers to as “basic” nonattainment) contains general requirements for nonattainment areas for any pollutant, including ozone, governed by a NAAQS. Subpart 2 (which EPA refers to as “classified” nonattainment) provides more specific requirements for ozone nonattainment areas. Under EPA's Phase 1 8-hour ozone implementation rule, (69 FR 23951 (April 30, 2004)), an area was classified under subpart 2 based on its 8-hour ozone design value (i.e., the 3-year average annual fourth-highest daily maximum 8-hour average ozone concentration), if it had a 1-hour design value at the time of designation at or above 0.121 ppm (the lowest 1-hour design value in Table 1 of subpart 2) (69 FR 23954). All other areas were covered under subpart 1, based upon their 8-hour design values (69 FR 23958). The Muskegon and Cass County areas were designated as subpart 2, 1-hour ozone moderate  1 nonattainment areas by EPA on April 30, 2004, (69 FR 23857, 23911), based on air quality monitoring data from 2001-2003. The Flint, Grand Rapids, Kalamazoo-Battle Creek, Lansing-East Lansing, Benton Harbor, Benzie County, Huron County, and Mason County areas were all designated as subpart 1, 8-hour ozone nonattainment areas by EPA on April 30, 2004, (69 FR 23857, 23910-23911) based on 2001-2003 air quality monitoring data.

Under section 181(a)(4) of the CAA, EPA may adjust the classification of an ozone nonattainment area to the next higher or lower classification if the design value for the area is within five percent of the cut-off for that higher or lower classification. On September 22, 2004, EPA adjusted the classification of several nonattainment areas which had been designated and classified under subpart 2 on April 30, 2004. At that time, EPA adjusted the classifications of the Muskegon and Cass County nonattainment areas from moderate to marginal (69 FR 56697, 56708-56709). It should be noted that the United States Court of Appeals for the District of Columbia Circuit has recently vacated EPA's April 30, 2004 “Final Rule to Implement the 8-Hour Ozone National Ambient Standard” (the Phase 1 implementation rule). South Coast Air Quality Management District v. EPA , No. 04-1200., 472 F.3d 882 (DC Cir. 2007). EPA issued a supplemental proposed rulemaking that set forth its views on the potential effect of the Court's ruling on these and other proposed redesignation actions. 72 FR 13452 (March 22, 2007) See discussion below.

40 CFR Section 50.10 and 40 CFR Part 50, Appendix I provide that the 8-hour ozone standard is attained when the 3-year average of the annual fourth-highest daily maximum 8-hour average ozone concentration is less than or equal to 0.08 ppm, when rounded. The data completeness requirement is met when the average percent of days with valid ambient monitoring data is greater than 90%, and no single year has less than 75% data completeness. See 40 CFR Part 50, Appendix I, 2.3(d).

On May 9, 2006, Michigan requested that EPA redesignate the Grand Rapids, Kalamazoo-Battle Creek, Lansing-East Lansing, Benzie County, Huron County, and Mason County areas to attainment for the 8-hour ozone standard. The State supplemented its redesignation requests on May 26, 2006 and August 25, 2006. The redesignation requests included three years of complete, quality-assured data for the period of 2002 through 2004, as well as complete quality assured data for 2005, indicating the 8-hour NAAQS for ozone had been attained for all of the areas covered by the request. Subsequently EPA reviewed the quality assured monitoring data for 2004-2006. These data show that these areas continued to attain the standard for 2004-2006. See Table 1 below.

On June 13, 2006, Michigan requested that EPA redesignate the Flint, Muskegon, Benton Harbor, and Cass County areas to attainment for the 8-hour ozone standard. The State supplemented its requests on August 25, 2006 and November 30, 2006. The redesignation requests included three years of complete, quality-assured data for 2004-2006, indicating the 8-hour NAAQS for ozone had been attained for all of the areas covered by the request. Data submitted by the State also showed attainment in 2003-2005. Under the CAA, nonattainment areas may be redesignated to attainment if sufficient complete, quality-assured data are available for the Administrator to determine that the area has attained the standard, and the area meets the other CAA redesignation requirements in section 107(d)(3)(E).

On December 7, 2006 (71 FR 70915), EPA proposed to make determinations that the Grand Rapids, Kalamazoo-Battle Creek, Lansing-East Lansing, Benzie County, Huron County, and Mason County areas have attained the 8-hour ozone NAAQS, and to approve the redesignations of the areas from nonattainment to attainment for the 8-hour ozone NAAQS. EPA also proposed to approve maintenance plan SIP revisions for the Grand Rapids, Kalamazoo-Battle Creek, Lansing-East Lansing, Benzie County, Huron County, and Mason County areas. Additionally, EPA found adequate and proposed to approve the 2018 Motor Vehicle Emissions Budgets (MVEBs) submitted by Michigan for these areas in conjunction with the redesignation requests.

On January 8, 2007 (72 FR 699), EPA proposed to make determinations that the Flint, Muskegon, Benton Harbor, and Cass County areas have attained the 8-hour ozone NAAQS, and to approve the redesignations of the areas from nonattainment to attainment for the 8-hour ozone NAAQS. EPA also proposed to approve the maintenance plan SIP revisions for the Flint, Muskegon, Benton Harbor, and Cass County areas. Additionally, EPA found adequate and proposed to approve the 2018 MVEBs submitted by Michigan for these areas in conjunction with the redesignation requests. The rationale for EPA's proposed actions is explained in the notices of proposed rulemaking and will not be restated here.

In addition, as noted above, EPA issued a supplemental proposed rulemaking setting forth EPA's views on the potential impact of the Court's ruling in South Coast Air Quality Management District v EPA . EPA provided a 15-day review and comment period on this supplemental proposed rulemaking. The public comment period closed on April 6, 2007. EPA received six comments, all supporting EPA's supplemental proposed rulemaking, and supporting redesignation of the affected areas. EPA recognizes the support provided in these comments but does not believe any specific response to comments is necessary with respect to these comments. In addition, several of these comments included additional rationale for proceeding with these proposed designations. EPA had not requested comment on any additional rationale, does not believe any additional rationale is necessary, and similarly does not believe any specific response to these comments is necessary, and thus has not provided any.

EPA provided a 30-day review and comment period on the proposed rules. The public comment periods closed on January 1, 2007 and February 7, 2007. EPA received a letter from the Crystal Lake Watershed Association in favor of the redesignation of Benzie County. EPA received adverse comments from the Little River Band of Ottawa Indians and from three citizens. Unless an area was specifically identified by the commentor, EPA assumed that the comment applied to all areas. A summary of the adverse comments received, and EPA's responses, follows.

(1) Comment: Redesignation of Mason, Benzie and Muskegon Counties at this time would be premature because the data are misleading. Although the three-year averages for both Mason and Benzie Counties during the period of 2002-2004, 2003-2005 and 2004-2006 were less than 0.085 parts per million (ppm), which puts both counties into attainment for the 8-hour ozone NAAQS, 2004 was a statistical outlier. This argument could be extended to other counties affected by EPA's proposals.

Response: The CAA provides the requirements for redesignating a nonattainment area to attainment. Specifically, section 107(d)(3)(E) allows for redesignation provided that, among other things, the Administrator determines that the area has attained the applicable NAAQS. A determination that an area has attained the standard is based on an objective review of air quality data. There are no provisions in the CAA or in EPA redesignation policy for using monitoring data trends or statistical analyses as criteria for determining attainment in evaluating a redesignation request.

EPA promulgated the current 8-hour ozone standard on July 18, 1997 (62 FR 38856). As discussed in detail in the proposed rule, an area is considered to be in attainment of the 8-hour ozone standard if the 3-year average of the fourth-highest daily maximum 8-hour average ozone concentrations measured at each monitor within an area over each year does not exceed 0.084 ppm. Three years of air quality data are used to allow for year-to-year variations in meteorology. The three year averaging period provides a reasoned balance between evening out meteorological effects and properly addressing real changes in emission levels. See 66 FR 53094, 53100 (October 19, 2000) (redesignation of Pittsburgh) and 69 FR 21717, 21719-21720 (April 22, 2004) (determination of attainment for the Bay Area). In the case of Mason and Benzie Counties, both areas have attained the standard for three three-year periods, which is also the case for the Grand Rapids, Kalamazoo-Battle Creek, Lansing-East Lansing and Huron County areas. The Muskegon area has attained the standard for two three-year periods, which is also the case for the Flint, Benton Harbor and Cass County areas. In all cases, these areas have demonstrated attainment for longer than is required. As the commentor acknowledges, the areas are monitoring attainment of the 8-hour standard. EPA has no basis for using other criteria to determine if an area is attaining the 8-hour ozone NAAQS.

It should be noted that, to put recent western Michigan meteorological monitoring data into perspective, EPA obtained historical temperature data recorded at the Muskegon County Airport from the National Oceanic and Atmospheric Administration's (NOAA) National Climate Data Center. Review of average high temperatures and number of days with temperatures greater than or equal to 90°F recorded over the ozone season for the past 50 years indicates that the year-to-year variations recorded from 2003-2006, are typical of historical values. Average high temperatures are above the 50 year average for 2003, 2005 and 2006 and slightly below the 50 year average for 2004. Taken together, average high temperatures for the 2003-2005 and 2004-2006 time periods are above the 50 year average. Considering the number of days with temperatures of 90°F or greater, values for the 2003-2005 and 2004-2006 time periods are above the 50 year average. This information does not support the commentor's contention that abnormal meteorology was responsible for improvements in air quality.

In addition, as discussed at length in the proposals, the areas have met the separate redesignation requirement of demonstrating that the improvement in air quality is due to permanent and enforceable emissions reductions. This further refutes the contention that favorable meteorology accounts for attainment.

(2) Comment: EPA should look with more scrutiny at the 4th highest 8-hour averages for each year. Reviewing these values, it is difficult to predict whether Benzie, Mason, and Muskegon Counties will be able to maintain the ozone standard starting with the 2005-2007 data, since the failing values for next year are close to what the values have been for the past two years. Muskegon has a failing value lower than the 4th highest 8-hour average for every year except 2004.

Response: As discussed above, neither the CAA nor EPA's interpretation of CAA requirements in policy memoranda provide for using monitoring data trends or statistical analyses as criteria for determining attainment for evaluating a redesignation request. Section 107(d)(3)(E) of the CAA allows for redesignation provided that, among other things, the Administrator determines that the area has attained the applicable NAAQS. As described in detail in the proposed rules, the Grand Rapids, Kalamazoo-Battle Creek, Lansing-East Lansing, Muskegon, Benton Harbor, Flint, Benzie County, Cass County, Huron County, and Mason County areas are all monitoring attainment of the 8-hour ozone NAAQS.

In addition, consistent with the requirements of sections 175A and 107(d)(3)(E) of the CAA, Michigan has submitted maintenance plans for the areas which show continued maintenance and continuing reductions in NO X and VOC emissions through 2018, further decreasing peak ozone levels and maintaining ozone attainment. It should also be noted that reductions in emissions that have occurred and that will continue to occur in upwind areas will contribute to maintenance of the NAAQS in these areas. Some of these measures include the NO X SIP call, stationary source NO X regulations, the National Low Emission Vehicle (NLEV) program, Tier 2 emission standards for vehicles (Tier 2), low sulfur diesel fuel standards and heavy-duty diesel engine standards. Additionally, Illinois, Indiana, Wisconsin, and Michigan, along with 25 other states and the District of Columbia, are subject to the Clean Air Interstate Rule, which should result in reduced NO X emissions and a reduction in transported ozone. Furthermore, as demonstrated by the contingency measure provisions required by section 175A(d), the CAA clearly anticipates and provides for situations where an area might monitor a violation of the NAAQs after having been redesignated to attainment. Michigan has included contingency measure provisions consistent with CAA requirements in their maintenance plans to address any possible future violation of the NAAQS.

(3) Comment: The results from 2004 are abnormally low due solely to the weather. While we agree that there is an overall downward trend, we insist that the unfavorable weather for ozone formation led to atypically low results in 2004. The results for that year are single handedly dragging down the three year average and artificially bringing the areas into attainment before they have reached a maintainable situation. The commentor is particulary concerned with the Benzie County, Mason County, and Muskegon areas.

Response: It should be noted that as discussed above, the year to year temperature variations recorded from 2003-2006, are typical of historical values and EPA does not believe that the 2004 data were abnormally low. Moreover, as discussed in greater detail above, section 107(d)(3)(E)(i) of the CAA requires that the Administrator determine that the area has attained the applicable NAAQS. A determination that an area has attained the NAAQS is based on an objective review of air quality data. An area is considered to be in attainment of the 8-hour ozone standard if the 3-year average of the fourth-highest daily maximum 8-hour average ozone concentrations measured at each monitor within an area over each year does not exceed 0.084 ppm. Three years of air quality data are used to allow for year-to-year variations in meteorology. The adequacy of the ozone standard is not at issue in this rulemaking. Comments regarding the adequacy of the ozone standard would have more appropriately been submitted in response to the proposal of the 8-hour standard.

In addition, as discussed above, Michigan has submitted maintenance plans which show continuing reductions in NO X and VOC emissions through 2018, and include contingency measure provisions to address any possible future violation of the NAAQS. Moreover, as discussed in the proposals, 71 FR 70921 (December 7, 2006) and 72 FR 704-705 (January 8, 2007), Michigan has shown that the improvement in air quality is due to permanent and enforceable emissions reductions, and not to favorable meteorology. Emission reductions from within the areas, as well as regional reductions from upwind areas, are responsible for attainment. Reductions in VOC and NO X emissions have occurred in Michigan, as well as in upwind areas, as a result of Federal emission control measures, with additional emission reductions expected to occur in the future. Federal emission control measures include: The NLEV program, Tier 2 emission standards for vehicles, gasoline sulfur limits, low sulfur diesel fuel standards, and heavy-duty diesel engine standards. In accordance with EPA's NO X SIP call, Michigan developed rules to control NO X emissions from electric generating units (EGUs), major non-EGU industrial boilers, and major cement kilns. Between 2000 and 2004, this resulted in a 40,577 ton reduction in ozone season NO X emissions. Illinois and Indiana have also adopted regulations to comply with the NO X SIP call which have resulted in a 155,831 ton reduction in ozone season NO X emissions between 2000 and 2004. While Wisconsin was not subject to the NO X SIP call, the state has adopted NO X regulations to meet rate of progress requirements. The emission reductions from all of these programs are permanent and enforceable.

(4) Comment: MDEQ's maintenance plans do not address the fact that the Lake Michigan shoreline counties are overwhelmingly impacted by ozone originating from sources across the lake in the Chicago-Gary-Milwaukee area. Instead, MDEQ insists on controlling local sources when the reason for the problem is solely rooted in pollution traveling on prevailing winds across the lake. It is disingenuous for MDEQ to submit a maintenance plan to EPA that does not address the need for controlling these distant sources as they are the root cause. Furthermore, it is equally as wrong for EPA to accept such a request without reassurances from MDEQ in writing to pursue its options in Section 126 of the CAA regardless of the consequences. EPA should deny MDEQ's request unless they include Section 126 provisions in the maintenance plan. If EPA chooses to accept this request without commitments in writing from MDEQ to pursue its options under Section 126, then the onus is on EPA to pursue those actions. The commentor is particularly concerned with the Benzie County, Mason County and Muskegon areas.

Response: MDEQ has included in its maintenance plans, control measures which the State has the authority to adopt and enforce. MDEQ does not have the authority to adopt and enforce measures to control sources located in Illinois, Indiana, or Wisconsin. It would be inappropriate for the State to include in its maintenance plans contingency measures that it could neither adopt nor enforce.

Section 110(a)(2)(D) of the CAA, which applies to all SIPs for each pollutant covered by a NAAQS, and for all areas regardless of their attainment designation, provides that a SIP must contain provisions preventing its sources from contributing significantly to nonattainment problems or interfering with maintenance in downwind States.

Section 126 of the CAA authorizes a downwind state to petition EPA for a finding that any new or existing major stationary source or group of stationary sources upwind of the state emits or would emit in violation of the prohibition of section 110(a)(2)(D) because their emissions contribute significantly to nonattainment, or interfere with maintenance, of a NAAQS in the state. Michigan retains the authority, under section 126 of the CAA, to petition EPA should this become necessary in the future. It is unnecessary for Michigan to cite section 126 of the CAA in its maintenance plans to preserve this option. Upwind areas will remain subject to the provisions of section 110(a)(2)(D) and section 126 after the areas are redesignated to attainment, and redesignation will not remove the protections of these provisions for lakeshore counties.

Furthermore, Section 110(k)(5) authorizes EPA to find that a SIP is substantially inadequate to meet any CAA requirement, as well as to mitigate interstate transport of the type described in section 184 (concerning ozone transport in the northeast) or section 176A (concerning interstate transport in general), and thereby require the State to submit, within a specified period, a SIP revision to correct the inadequacy. EPA exercised this authority in issuing the NO X SIP call, and would do so again, as necessary, if it finds that SIPs do not adequately address transport.

In fact, upwind areas, including Chicago-Gary-Lake County, IL-IN and Milwaukee-Racine, WI, are continuing to implement measures to reduce ozone precursors; including the NO X SIP call, stationary source NO X regulations, NLEV, Tier 2, low sulfur diesel fuel standards and heavy-duty diesel engine standards. Additionally, Illinois, Indiana, Wisconsin, and Michigan, along with 25 other states and the District of Columbia, are subject to the Clean Air Interstate Rule, which should result in reduced NO X emissions and a reduction in transported ozone.

(5) Comment: One commenter disagreed with the assertion that Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, dated Nov. 6, 2000, (E.O. 13175) does not apply to the Region's proposed approval of MDEQ's requests to redesignate certain counties from “non-attainment” to “attainment” for ozone pursuant to Section 107(d) of the Clean Air Act. The commenter states that EPA's action has tribal implications under E.O. 13175.

Response: E.O. 13175 was signed on November 6, 2000, and sets forth various provisions regarding consultation and coordination between Federal agencies undertaking “policies that have tribal implications” and Indian tribal governments. Under E.O, 13175, the term “policies that have tribal implications” refers to “regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects 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.”

It is not necessary to address the scope of E.O. 13175 at this time. Federal policy and EPA's 1984 Indian Policy encourage the Agency to consult with Tribes prior to taking actions that affect Tribal governments. Recognizing tribal interest in this matter, the Region offered to consult with all Michigan Tribes with respect to the redesignation requests. Five Tribes accepted this offer, and consultation occurred by means of a conference call on August 30, 2006 and a face-to-face meeting held at the Nottawaseppi Huron Band of Potawatomi Indians tribal center on September 26, 2006. Consequently, the purposes of the executive order were satisfied in this case.

(6) Comment: Even though EPA was only required to consult with tribes once, it is by no means prohibited from talking to them again. At the very least there are two requests submitted by MDEQ (May 9, 2006 and June 13, 2006) which should translate to two consultation processes. Furthermore, the effectiveness of the consultation process has been significantly diminished since the current Regional Administrator and Air Division Director were not in their current positions or on leave when the meeting took place.

Response: We believe that the consultation process was constructive and appreciate the considered comments provided by the Little River Band of Ottawa Indians. However, at this time we believe that the conference call and meeting constitute adequate consultation and do not believe that value would be added through additional consultation on this issue. Both the May 9, 2006, and June 13, 2006, redesignation submittals were discussed in the conference call and at the meeting. Furthermore, the comments do not raise any issues that were not discussed during the consultation. With respect to EPA management changes, we believe that this has no bearing on the effectiveness or adequacy of the consultation process. Appropriate EPA representatives participated in the consultation process and current management has been comprehensively briefed.

(7) Comment: The CAA requires EPA to act within 18 months of the submission of a redesignation request. Michigan submitted the requests on May 9, 2006 and June 13, 2006. This means EPA does not have to approve or deny the requests until November 9, 2007 and December 13, 2007, respectively. Thus, EPA could choose to wait and see what will happen with these counties after the end of next ozone season. More importantly though, EPA could see what the three-year average is without the abnormally low 2004 data skewing the results. EPA should hold off on redesignating these counties until after 2007's ozone season is complete.

Response: As noted above in responses to comments, the year to year temperature variations recorded from 2003-2006, are typical of historical values and EPA does not believe that the 2004 data were abnormally low. Moreover, as set forth above in response to comments, three years of air quality data are used in determining attainment with the standard to allow for year-to-year variations in meteorology. In any event, delay of the redesignation is not necessary because the Grand Rapids, Kalamazoo-Battle Creek, Lansing-East Lansing, Muskegon, Benton Harbor, Flint, Benzie County, Cass County, Huron County, and Mason County areas are all in attainment of the 8-hour ozone standard and have otherwise met all applicable requirements for redesignation. For the Grand Rapids, Kalamazoo-Battle Creek, Lansing-East Lansing, Benzie County, Huron County, and Mason County areas, attainment was achieved at the end of the 2004 ozone monitoring season, when each of the areas attained the ozone standard with quality assured 2002-2004 monitoring data. Since that time, MDEQ has collected and reported quality assured monitoring data for 2005 and 2006, resulting in three 3-year periods of monitored attainment. For the Flint, Muskegon, Benton Harbor, and Cass County areas, attainment was achieved at the end of the 2005 ozone monitoring season, when each of the areas attained the ozone standard with quality assured 2003-2005 monitoring data. Since that time, MDEQ has collected and reported quality assured monitoring data for 2006, resulting in two 3-year periods of monitored attainment. Furthermore, as demonstrated in Michigan's maintenance plans, VOC and NO X emissions will continue to decline through 2018, further decreasing peak ozone levels and maintaining attainment of the ozone standard. MDEQ has met all of the criteria for redesignation contained in the CAA; therefore EPA has no basis for delaying approval of the State's request.

(8) Comment: For the Mason County ozone monitor, MDEQ discounted the 8-hour average value of 0.089 ppm, recorded on June 17, which was the 3rd highest 8-hour average for 2006. This change caused the 4th highest value to drop from 0.083 ppm to 0.076 ppm. The reason given for discounting monitoring data recorded on June 17 at the Mason County ozone monitor was that the shelter temperature exceeded acceptable limits due to a faulty air conditioner. Obviously, such failures skew samples results since the ozone is no doubt highest when high temperatures also prevail. Certainly, days discounted that are among the four highest are much more significant than those below it. Thus, it seems there should be a mechanism for documenting discounted days amongst the four highest for any monitor and the reason for discounting the data.

Response: EPA has established specific quality assurance criteria for the collection of ambient data. One of these criteria, stated in Part 1, Section 7.1.2 of the EPA's “Quality Assurance Handbook for Air Pollution Measurement Systems,” is that ozone analyzers must be operated within a specific temperature range (20 °C to 30 °C). This temperature range is set because the instruments have been tested and qualified in this range of temperatures. Establishing a range of operating temperature ensures that the instrument's reported concentrations do not drift from actual concentration; therefore, when the temperature exceeds this range, data are no longer considered to have met the quality objectives and are considered missing for regulatory data calculations.

In the EPA Air Quality Database (AQS), each hour has an ozone value and can be flagged for a variety of quality assurance reasons, including the shelter temperature being out of acceptable range. If the hourly value is flagged, then that hour is not used in the computation of the maximum 8-hour average. Every eight-hour average must have at least 6 hours of valid hourly values, otherwise it is assigned the value of missing. An ozone monitoring day is counted as a valid ozone monitoring day if at least 18 of the 24 possible 8-hour average periods are available, or the daily maximum 8-hour average concentration is greater than 0.08 ppm. Invalid days count against the design value completeness criteria; i.e. , 75% per year and 90% over three years.

MDEQ appropriately flagged its hourly ozone concentrations in the AQS database when the monitoring shelter temperature exceeded 30 ° C and they correctly calculated the daily and annual statistics according to the EPA's “Guideline on Data Handling Conventions for the 8-hour Ozone NAAQS.” Furthermore, regardless of whether 0.083 ppm or 0.076 ppm is used as the 4th highest 8-hour average for 2006, the area is monitoring attainment of the 8-hour ozone NAAQS for the 2004-2006 period.

(9) Comment: June 17 was in the top four highest days at 20 out of 28 other Michigan sites for 2006. The Little River Band of Ottawa Indians operates an ozone monitor in Manistee County, which is the closest one to Mason County's monitor. The tribal monitor has a 4th highest 8-hour average of 0.083 ppm for 2006 as did Mason's before the removal of the June 17 reading. Could data from the tribal monitor be used to supplement missing data at the Mason County monitor?

Response: As explained in EPA's “Guideline on Data Handling Conventions for the 8-hour Ozone NAAQS,” in certain situations, credit can be given toward meeting the 75% minimum data completeness requirement for days with monitoring data that would have had low ozone concentrations. However, as long as a site meets the 75% minimum data completeness requirement in a given year, EPA does not require that data substitution from nearby monitors occur for days that are missing data. The Mason County monitoring site meets the 75% requirement in 2006, so there is no requirement to assess nearby monitors on days with missing data. Also, as noted above, regardless of whether 0.083 ppm or 0.076 ppm is used as the 4th highest 8-hour average for 2006, the area is monitoring attainment of the 8-hour ozone NAAQS for the 2004-2006 period.

(10) Comment: For the Grand Rapids, Kalamazoo-Battle Creek, Lansing-East Lansing, Benzie County, Huron County, and Mason County areas, Michigan used emissions data from 1999 and 2002 to show that the improvement in air quality was due to permanent and enforceable reductions in emissions. Why would the state choose a time period the EPA used to designate the area nonattainment?

Response: In developing an attainment inventory, Michigan could have chosen any of the years that the areas were monitoring attainment of the standard. Michigan developed the redesignation request based on ambient monitoring for the 2002-2004 time period showing that the areas had attained the NAAQS. (The areas have continued to monitor attainment for the 2003-2005 and 2004-2006 time periods.) It would have been acceptable for MDEQ to choose any of the three years, 2002, 2003, or 2004, as the year for the attainment inventory. (Because the areas continue to attain the NAAQS, 2005 or 2006 would also have been acceptable attainment years.) Michigan had developed a detailed emissions inventory for 2002 in support of regional modeling efforts, and chose this year for its attainment inventory. As discussed in more detail in the proposed rule (71 FR 70921), MDEQ demonstrated emissions reductions from 1999 to 2002 and detailed permanent and enforceable control measures over this time period that were responsible for the reduction in emissions. If Michigan had chosen a later year for its attainment inventory, it could have documented an even greater reduction in emissions, as the state has documented increasing emissions reductions from 2002 through 2018. Between 2002 and 2006, these areas, as well as areas upwind, have experienced further reductions in motor vehicle emissions due to the implementation of the NLEV program, Tier 2 emission standards for vehicles, gasoline sulfur limits, low sulfur diesel fuel standards, and heavy-duty diesel engine standards. In addition, the NO X SIP call required large reductions in NO X , beginning in 2004, for both Michigan and upwind areas. The emission reductions from all of these programs are permanent and enforceable.

(11) Comment: Air quality monitoring data for the Grand Rapids area shows an upward trend from 1997 through 2003. Why did EPA analyze 2002 emissions data to show the area has put on controls, when monitoring data indicates air quality problems?

Response: Considering monitoring data from 1999 through 2006, which covers the time period that the Grand Rapids area is using to demonstrate monitored attainment with the standard, there are year to year variations, but overall ozone levels appear to be declining. The fact that the area has continued to monitor attainment of the standard for the three most recent three-year periods supports this view. As noted above, in response to Comment 10, Michigan could have chosen for its attainment inventory any of the years that the area was monitoring attainment of the standard. The state chose 2002 as the attainment year and documented permanent and enforceable control measures which were responsible for the reduction in emissions over the 1999-2002 time period. Table 5 set forth in the proposal (17 FR 70922, 70924) shows that the Grand Rapids area reduced VOC emissions by 9,949 tpy (18%) and NO X emissions by 20,276 tpy (28%). Had the state chosen a later attainment year, an even greater reduction in emissions could have been shown, as the state has documented increasing emissions reductions from 2002 through 2018. In addition to the emissions reductions documented in Table 5 of the proposal, subsequent emissions reductions in later years were obtained from the NLEV program, Tier 2 emission standards for vehicles, gasoline sulfur limits, low sulfur diesel fuel standards, heavy-duty diesel engine standards, and the NO X SIP call. Upwind areas have also experienced emissions reductions from these programs. See Response to Comment 10, above.

(12) Comment: Levels of ozone, particulate matter and other pollutants remain unacceptably high. EPA should require Michigan to move toward policies which improve air quality and pressure the Chicago, Illinois and Gary, Indiana areas to reduce pollution, which is transported to Michigan.

Response: Under section 109 of the CAA, EPA is charged with promulgating NAAQS for criteria pollutants (including ozone and particulate matter) at levels protective of public health and welfare. EPA promulgated NAAQS for 8-hour ozone on July 18, 1997 (62 FR 38856). The Grand Rapids, Kalamazoo-Battle Creek, Lansing-East Lansing, Muskegon, Benton Harbor, Flint, Benzie County, Cass County, Huron County, and Mason County areas have demonstrated attainment of the 8-hour ozone standard. It should be noted that while this action does not relate to particulate matter, all of these areas are designated as attainment for particulate matter as well.

This rule is a redesignation action that is designed to determine whether an area has met the requirements for redesignation to attainment for 8-hour ozone. Considerations of how to address issues of transport from upwind areas not related to the current redesignation action are not relevant for purposes of this action. As discussed elsewhere in responses to comments, Sections 126 and 110(a)(2)(D) remain available as mechanisms to address transport problems regardless of whether an area has been redesignated to attainment.

It should be noted, however, that considerable progress has been made in reducing transported pollution. EPA has adopted and implemented the NO X SIP call, which has significantly reduced NO X emissions throughout the eastern half of the United States. In Michigan, Illinois, and Indiana alone, the NO X SIP call has been responsible for a reduction in ozone season NO X emissions in excess of 196,400 tons between 2000 and 2004. Other Federal measures including the NLEV program, Tier 2 emission standards for vehicles, gasoline sulfur limits, low sulfur diesel fuel standards, and heavy-duty diesel engine standards continue to be implemented and should result in reductions in upwind emissions. In addition, EPA finalized the Clean Air Interstate Rule (CAIR) on May 12, 2005. CAIR is designed to achieve large reductions of sulfur dioxide (SO 2 ) and/or NO X emissions across 28 eastern states and the District of Columbia and specifically addresses the transported pollution from upwind states that affects downwind air quality problems. (Illinois, Indiana, Wisconsin and Michigan are all subject to CAIR.) SO 2 and NO X contribute to the formation of fine particles and NO X contributes to the formation of ground-level ozone.

(13) Comment: A commentor notes that EPA's 8-hour ozone designation Web site lists the 2001-2003 design value for the Grand Rapids area as 0.089 ppm. The commentor states that the design value for the area should be 0.090 ppm, based on the Jennison monitor.

Response: Yearly 4th high 8-hour ozone averages at the Jennison monitor for the years 2001-2003 are 0.086, 0.093, and 0.090 ppm, respectively. Using the calculation procedures described in 40 CFR Part 50, Appendix I, which call for truncating after the third decimal place, rather than rounding, the 3-year average of the fourth-highest daily maximum 8-hour average ozone concentrations, i.e. , the design value, is 0.089 ppm.

(14) Comment: Considering the 4th highest 8-hour average for each year for each monitor in the Grand Rapids-Muskegon-Holland Consolidated Statistical Area, rather than the design value, long term trends show a regional air quality pattern of elevated and violating ozone concentrations.

Response: It should be noted that the commentor is citing three separate nonattainment areas as if they were one entity. The Grand Rapids and Muskegon areas are monitoring attainment of the 8-hour ozone NAAQS and EPA has proposed to approve Michigan's requests to redesignate these areas to attainment. The Allegan County area (Holland) continues to monitor violations of the 8-hour ozone standard. Michigan has not requested that the Allegan County area be redesignated and this area is not addressed in this rulemaking.

That being said, as discussed above, neither the CAA nor EPA's interpretation of CAA requirements in policy memoranda provide for using monitoring data trends or statistical analyses as criteria for ascertaining attainment for purposes of redesignation. Section 107(d)(3)(E) of the CAA allows for redesignation provided that, among other things, the Administrator determines that the area has attained the applicable NAAQS. As described in detail in the proposed rules, the Grand Rapids and Muskegon areas are monitoring attainment of the 8-hour ozone NAAQS.

Furthermore, maintenance plans for Grand Rapids and Muskegon project maintenance of the standard through 2018. For Grand Rapids, the maintenance plan shows that the area will maintain the standard with emissions reductions of 27% and 63% for VOC and NO X , respectively, between 2002 and 2018. For Muskegon, the maintenance plan shows that the area will maintain the standard with emissions reductions of 19% and 31% for VOC and NO X , respectively, between 2005 and 2018. See 71 FR 70925 and 72 FR 707. Moreover, as described above in responses to comments, continuing reductions in emissions from upwind areas will further contribute to maintenance of the standard.

(15) Comment: EPA granted Michigan's requests to be exempt from NO X RACT regulation requirements when NO X has been pointedly and repeatedly implicated in the ozone formation process around Lake Michigan. Based on regional modeling performed by the Lake Michigan Air Directors Consortium, EPA should retract all NO X waiver requests involving the areas until such time that the associated NO X control measures are shown to be completely ineffective at addressing ozone air quality improvement in all areas impacted by those emissions.

Response: EPA approved section 182(f) NO X waivers for the Grand Rapids, Kalamazoo-Battle Creek, Lansing-East Lansing, Benzie County, Huron County, and Mason County areas on June 6, 2006 (71 FR 32448). The issuance of NO X waivers for these areas is not at issue in this rulemaking. This comment would have more appropriately been submitted in response to the proposal to grant these waivers. The comment is not relevant to this redesignation action.

(16) Comment: There is not now any guarantee that a regional program will be adopted and implemented because areas in Region 5 are being allowed to be redesignated without viable maintenance plans that acknowledge the need for a comprehensive regional plan.

Response: The role of a redesignation action is to address air quality and regulatory requirements in an individual nonattainment area, and not to serve as a mechanism to address regional air quality issues. As noted above, MDEQ has included in its maintenance plans, control measures which the state has the authority to adopt and enforce. EPA has reviewed these maintenance plans and found that they provide for maintenance of the ozone standard in accordance with sections 175A and 107(d)(3)(E). MDEQ does not have the authority to adopt and enforce measures to control sources located in other states. Neither does it have the authority to unilaterally compel other states to participate in the adoption and implementation of a regional control program. It would be inappropriate for the State to include in its maintenance plans contingency measures that it could neither adopt nor enforce.

That being said, the redesignation of areas does not prohibit states from working together to ensure regional attainment and maintenance of the NAAQS. Indeed, it is in the states' best interest to do so. Section 110(a)(2)(D)(i) of the CAA requires states to include in their SIPs adequate provisions to prohibit any source or emissions activity within the state from emitting any air pollutant in amounts which will “contribute significantly to nonattainment in, or interfere with maintenance by, any other State with respect to any such national primary or secondary ambient air quality standard.* * *” The participation by states in multi-state regional planning facilitates the evaluation of states' responsibilities regarding this section of the CAA and promotes a cohesive plan for regional attainment and maintenance of the NAAQS. In fact, Michigan continues to participate in regional planning efforts through the Lake Michigan Air Director's Consortium.

Redesignation of an area does not insulate it from the requirements or protection of section 110(a)(2)(D). Section 126 is also available to states to petition for redress if sources in an upwind state contribute significantly to nonattainment, or interfere with maintenance, of a NAAQS in the state. See prior responses to comments.

In addition, as noted in prior responses to comments, regional emissions reductions due to the NO X SIP call, CAIR, and other regulations including the NLEV program, Tier 2 emission standards for vehicles, gasoline sulfur limits, low sulfur diesel fuel standards, and heavy-duty diesel engine standards will result in continued improvement in air quality throughout the region.

(17) Comment: There are not new controls on the books that will provide for demonstrated permanent air quality improvement by the expected attainment dates of 2007, 2009 and 2010.

Response: The Grand Rapids, Kalamazoo-Battle Creek, Lansing-East Lansing, Muskegon, Benton Harbor, Flint, Benzie County, Cass County, Huron County, and Mason County areas are all monitoring attainment of the 8-hour ozone NAAQS. Therefore, future attainment dates are irrelevant to the redesignation. Moreover, as discussed in the proposals, 71 FR 70921 (December 7, 2006) and 72 FR 704-705 (January 8, 2007), Michigan has shown that the improvement in air quality is due to permanent and enforceable emissions reductions. Emission reductions from within the areas as well as regional reductions from upwind areas are responsible for attainment. Reductions in VOC and NO X emissions have occurred in Michigan, as well as in upwind areas as a result of Federal emission control measures, with additional emission reductions expected to occur in the future. Federal emission control measures include: The NLEV program, Tier 2 emission standards for vehicles, gasoline sulfur limits, low sulfur diesel fuel standards, and heavy-duty diesel engine standards. In compliance with EPA's NO X SIP call, Michigan developed rules to control NO X emissions from Electric Generating Units (EGUs), major non-EGU industrial boilers, and major cement kilns. Illinois and Indiana have also adopted and implemented regulations to comply with the NO X SIP call which have resulted in a reduction in NO X emissions. While Wisconsin was not subject to the NO X SIP call, the state has adopted NO X regulations to meet rate of progress requirements. The emission reductions from all of these programs are permanent and enforceable. Furthermore, MDEQ's maintenance plans show continued reductions in ozone precursor emissions through 2018. EPA believes that the maintenance plans meet the requirements of sections 175A and 107(d)(3)(E). Future emissions reductions can be expected both in Michigan and in upwind areas from programs including the NLEV program, Tier 2 emission standards for vehicles, gasoline sulfur limits, low sulfur diesel fuel standards, heavy-duty diesel engine standards, clean air non-road diesel rule and CAIR.

(18) Comment: The string of 4 monitors going into and downwind of the heart of the Grand Rapids metro area depends on the Holland (Allegan County) site being the lakeshore site. There is no lakeshore monitor in Ottawa County. If there were, it would clearly indicate ozone values closer to the levels monitored in the adjacent county north (Muskegon) or the adjacent county south (Allegan).

Response: It should be noted that the ozone monitor in Muskegon County (the Muskegon area) is monitoring attainment of the ozone NAAQS; the monitor located in Allegan County is not. Michigan has not requested that the Allegan County area be redesignated and this area is not addressed in this rulemaking. EPA believes that the monitoring network for the Grand Rapids area satisfies the requirements of 40 CFR part 58, appendix D. The EPA has approved the Grand Rapids monitoring network as adequate and has not required a lakeshore monitor in Ottawa County. There is no basis on which to speculate what such a monitor would record if it were in place, and it would be inappropriate for EPA to use such speculation as a criterion for redesignation. As discussed above, section 107(d)(3)(E) of the CAA allows for redesignation provided that, among other things, the Administrator determines that the area has attained the applicable NAAQS. An area is considered to be in attainment of the 8-hour ozone standard if the 3-year average of the fourth-highest daily maximum 8-hour average ozone concentrations measured at each monitor within an area over each year does not exceed 0.084 ppm. The Grand Rapids area is monitoring attainment of the 8-hour ozone NAAQS, based on that criterion.

(19) Comment: EPA had previously approved Michigan's ozone monitoring plans with the understanding that the Grand Rapids metro area would be designated as a single area including all 4 counties (Allegan, Kent, Ottawa and Muskegon counties). All the counties contain urbanized areas and their metropolitan connections are clear in the driving/commuting and emissions statistics. EPA understood this when proposing the 8-hour designations based on the full metropolitan area. EPA utilized technical justifications for splitting the area into separate pieces that do not fit the criteria required in EPA's standing guidance. However, if the EPA feels the need to split the areas, then it should require a more protective monitor location for a monitor in Ottawa County. If classification is based on either the Holland or Muskegon site, then that test is met.

Response: There is nothing in the record that supports the commentor's allegation. Michigan has been operating an approved monitoring network over the entire time period in question. EPA believes that the monitoring network for the Grand Rapids area satisfies the requirements of 40 CFR part 58, appendix D. EPA designated and classified the four counties as three separate areas (Grand Rapids, Muskegon, and Allegan County) under both the 1-hour ozone standard (56 FR 56778, November 6, 1991) and the 8-hour ozone standard (69 FR 23910-23911, April 30, 2004), based on the ozone monitoring data for each respective area. The 8-hour ozone designations, including area boundaries and the underlying monitoring data used for such designations, are not at issue in this rulemaking. Comments regarding the appropriateness of the 8-hour ozone designations would have more appropriately been submitted during the designation process. They are not relevant to a rulemaking on the redesignation of the area.

Grand Rapids has an approved adequate monitoring network, and the monitors in Muskegon and Allegan are not relevant to making an attainment determination for Grand Rapids.

(20) Comment: The two-year average of fourth high 8-hour averages for Muskegon exceeds 0.085 ppm. According to the maintenance plan for Muskegon, MDEQ has six months from the close of the ozone season to review the circumstances leading to the high monitored values. This review should be completed by April 1, 2007. Will the review be completed by this date? What has MDEQ concluded?

Response: Neither the CAA nor EPA policy memoranda contain the requirement that a state begin to implement a maintenance plan that has not yet been approved into the SIP, much less establish its implementation as a criterion for redesignation. The State will be required to implement its maintenance plans when they are approved as revisions to the SIP.

EPA is taking several related actions. EPA is making determinations that the Flint, Grand Rapids, Kalamazoo-Battle Creek, Lansing-East Lansing, Muskegon, Benton Harbor, Benzie County, Cass County, Huron County, and Mason County areas have attained the 8-hour ozone NAAQS. EPA is also approving the State's requests to change the legal designations of the Flint, Grand Rapids, Kalamazoo-Battle Creek, Lansing-East Lansing, Muskegon, Benzie County, Cass County, Huron County, and Mason County areas from nonattainment to attainment for the 8-hour ozone NAAQS. EPA is also approving as SIP revisions Michigan's maintenance plans for the areas (such approval being one of the CAA criteria for redesignation to attainment status). Additionally, EPA is finding adequate and approving for transportation conformity purposes the 2018 MVEBs for the Flint, Grand Rapids, Kalamazoo-Battle Creek, Lansing-East Lansing, Muskegon, Benzie County, Cass County, Huron County, and Mason County areas. With respect to EPA's approval of the redesignation of each area and approval of its associated maintenance plan and MVEB's, EPA construes such actions as separate and independent from EPA's actions concerning the other areas subject to this rulemaking. Thus any challenge to EPA's action with respect to an individual area shall not affect EPA's actions with respect to the other areas named in this notice.

EPA finds that there is good cause for these actions to become effective immediately upon publication because a delayed effective date is unnecessary due to the nature of a redesignation to attainment, which relieves the area from certain CAA requirements that would otherwise apply to it. The immediate effective date for this action is authorized under both 5 U.S.C. 553(d)(1), which provides that rulemaking actions may become effective less than 30 days after publication if the rule “grants or recognizes an exemption or relieves a restriction” and section 553(d)(3) which allows an effective date less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” The purpose of the 30-day waiting period prescribed in 553(d) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. Today's rule, however, does not create any new regulatory requirements such that affected parties would need time to prepare before the rule takes effect. Rather, today's rule relieves the State of planning requirements for these 8-hour ozone nonattainment areas. For these reasons, EPA finds good cause under 5 U.S.C. 553(d)(3) for these actions to become effective on the date of publication of these actions.

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.

Executive Order 12898 establishes a Federal policy for incorporating environmental justice into Federal agency actions by directing agencies to identify and address, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority and low-income populations. Today's actions do not result in the relaxation of control measures on existing sources and therefore will not cause emissions increases from those sources. Overall, emissions in the areas are projected to decline following redesignation. Thus, today's actions will not have disproportionately high or adverse effects on any communities in the area, including minority and low-income communities

Because it is not a “significant regulatory action” under Executive Order 12866 or a “significant energy action,” 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. Redesignation of an area to attainment under section 107(d)(3)(E) of the Clean Air Act does not impose any new requirements on small entities. Redesignation is an action that affects the status of a geographical area and does not impose any new regulatory requirements on sources. 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 (2 U.S.C. 1505).

Executive Order 13175 (65 FR 67249, November 9, 2000) 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.” EPA has consulted with interested tribes in Michigan to discuss the redesignation process and the impact of a change in designation status of these areas on the tribes. Accordingly, EPA has complied with Executive Order 13175 to the extent that it applies to the action.

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). Redesignation is an action that merely affects the status of a geographical area, does not impose any new requirements on sources, or allows a state to avoid adopting or implementing other requirements, 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 approves a state rule implementing a Federal Standard.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTA), 15 U.S.C. 272, requires Federal agencies to use technical standards that are developed or adopted by voluntary consensus to carry out policy objectives, so long as such standards are not inconsistent with applicable law or otherwise impracticable. In reviewing program submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Absent a prior existing requirement for the state to use voluntary consensus standards, EPA has no authority to disapprove a program submission for failure to use such standards, and it would thus be inconsistent with applicable law for EPA to use voluntary consensus standards in place of a program submission that otherwise satisfies the provisions of the Act. Redesignation is an action that affects the status of a geographical area but does not impose any new requirements on sources. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.

This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

Under Section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 16, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See Section 307(b)(2))

This action applies to any source whose owner or operator is required to conduct performance testing to demonstrate compliance with applicable standards under the General Provisions for Standards of Performance for New Stationary Sources, for National Emission Standards for Hazardous Air Pollutants, and for National Emission Standards for Hazardous Air Pollutants for Source Categories.

In addition to being available in the docket, an electronic copy of this final action will also be available on the Worldwide Web (WWW) through the Technology Transfer Network (TTN). Following the Administrator's signature, a copy of the final amendments will be placed on the TTN's policy and guidance page for newly proposed or promulgated rules at http://www.epa.gov/ttn/oarpg. The TTN provides information and technology exchange in various areas of air pollution control.

The EPA received 15 sets of public comments on the proposed amendments to the General Provisions for Standards of Performance for New Stationary Sources, for National Emission Standards for Hazardous Air Pollutants, and for National Emission Standards for Hazardous Air Pollutants for Source Categories during the 90-day comment period. These comments were submitted to the rulemaking docket. The EPA has carefully considered these comments in developing the final amendments. Summaries of the comments and EPA's responses are contained in this preamble.

Under section 307(b)(1) of the Clean Air Act (CAA), judicial review of this final rule is available by filing a petition for review in the United States Court of Appeals for the District of Columbia Circuit by July 16, 2007. Only those objections to this final rule that were raised with reasonable specificity during the period for public comment may be raised during judicial review. Under section 307(b)(2) of the CAA, the requirements that are the subject of this final rule may not be challenged later in civil or criminal proceedings brought by EPA to enforce these requirements.

Section 307(d)(7)(B) of the CAA further provides a mechanism for us to convene a proceeding for reconsideration, “[i]f the person raising an objection can demonstrate to the EPA that it was impracticable to raise such objection within [the period for public comment] or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule.” Any person seeking to make such a demonstration to us should submit a Petition for Reconsideration to the Office of the Administrator, U.S. EPA, Room 3000, Ariel Rios Building, 1200 Pennsylvania Ave., NW., Washington, DC 20460, with a copy to both the person(s) listed in the preceding FOR FURTHER INFORMATION CONTACT section, and the Associate General Counsel for the Air and Radiation Law Office, Office of General Counsel (Mail Code 2344A), U.S. EPA, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

The information presented in this preamble is organized as follows:

The final rule allows source owners or operators, in the event of a force majeure, to petition the Administrator for an extension of the deadline(s) by which they are required to conduct an initial or subsequent performance test required by applicable regulations. Performance tests required as a result of enforcement orders or enforcement actions are not covered by this rule because enforcement agreements contain their own force majeure provisions. A “force majeure” is defined as an event that will be or has been caused by circumstances beyond the control of the affected facility, its contractors, or any entity controlled by the affected facility that prevents the owner or operator from complying with the regulatory requirement to conduct performance tests within the specified timeframe despite the affected facility's best efforts to fulfill the obligation. Examples of such events are acts of nature, acts of war or terrorism, or equipment failure or safety hazard beyond the control of the affected facility.

If an affected owner or operator intends to assert a claim that a force majeure is about to occur, occurs, or has occurred, the owner or operator must notify the Administrator, in writing, as soon as practicable following the date the owner or operator first knew, or through due diligence should have known, that the event may cause or caused a delay in testing beyond the regulatory deadline. The owner or operator must provide a written description of the event and a rationale for attributing the delay in testing beyond the regulatory deadline to the force majeure; describe the measures taken or to be taken to minimize the delay; and identify a date by which the owner or operator proposes to conduct the performance test. The test must be conducted as soon as practicable after the force majeure occurs.

The decision as to whether or not to grant an extension to the performance test deadline is solely within the discretion of the Administrator. The Administrator will notify the owner or operator in writing of approval or disapproval of the request for an extension as soon as practicable. If an owner or operator misses its performance test deadline due to a force majeure event, and the request for an extension is subsequently approved, the owner or operator will not be held in violation for failure to conduct the performance test within the prescribed regulatory timeframe.

We recognize that there may be circumstances beyond a source owner's or operator's control constituting a force majeure event that could cause an owner or operator to be unable to conduct performance tests before the regulatory deadline. We developed this rule to provide a mechanism for consideration of these force majeure events and granting of extensions where warranted. Under current rules, a source owner or operator who is unable to comply with performance testing requirements within the allotted timeframe due to a force majeure is regarded as being in violation and subject to enforcement action. As a matter of policy, EPA often exercises enforcement discretion regarding such violations. However, where circumstances beyond the control of the source owner or operator constituting a force majeure prevent the performance of timely performance tests, we believe that it is appropriate to provide an opportunity to such owners and operators to make good faith demonstrations and obtain extensions of the performance testing deadline where approved by the Administrator in appropriate circumstances.

Comment: Five commenters requested that we clarify or define the approving authority.

Response: We inadvertently used two terms (Administrator and delegated agency) in the proposed rule. In 40 CFR Part 60 of the proposed rule, we stated that the owner or operator shall notify the Administrator of force majeure events, and in 40 CFR Parts 61 and 63 of the proposed rule, we stated that the owner or operator shall notify the delegated agency. We have replaced the term delegated agency with the term Administrator in 40 CFR Parts 61 and 63 of the final rule to be consistent with (1) the term (Administrator) used in 40 CFR Part 60 and (2) the term (Administrator) used in Parts 61 and 63 of the General Provisions that this final rule amends. Nonetheless, we believe that it may be appropriate for the Administrator to assign the responsibility of evaluating and approving or denying requests for extensions to performance test deadlines due to force majeure events to a duly delegated agency according to applicable procedures.

Comment: Six commenters stated that they thought the scope of the rule was too narrow and that circumstances beyond what they believed were covered by the definition of “force majeure” warranted similar extensions (e.g., pandemics, facility shutdowns, and process constraints that result in non-representative testing conditions).

Response: The proposed rule is not as narrow as indicated by commenters. Force majeure is defined as “an event that will be or has been caused by circumstances beyond the control of the affected facility, its contractors, or any entity controlled by the affected facility that prevents the owner or operator from complying with the regulatory requirement to conduct performance tests within the specified timeframe despite the affected facility's best efforts to fulfill the obligation.” Although we provide examples of events that could meet this definition (i.e., acts of nature, acts of war or terrorism, and equipment failure or safety hazards beyond the control of the affected facility), this list is not exhaustive. The focus of the rule and this definition is an event beyond the control of the affected facility. Similarly, two definitions of “force majeure” in dictionaries are “an unexpected or uncontrollable event” (The American Heritage Dictionary) and “an event or effect that cannot be reasonably anticipated or controlled” (Merriam-Webster's Online Dictionary). Thus, any event beyond the control of the affected facility may qualify for the extension. We can neither provide an exhaustive list of all of the possible events that may qualify as “force majeure” under this rule, nor determine whether the generic additional examples provided in the public comments would or would not qualify under all circumstances. The Administrator will exercise his or her discretion when considering requests for extensions to performance test deadlines due to “force majeure” events.

Comment: Six commenters requested that we expand the scope of the rule to allow the force majeure concept to justify extensions for additional regulatory requirements, such as monitoring, recordkeeping, reporting, maintenance, and inspections.

Response: The purpose of this rulemaking is to address requests for extensions to performance test deadlines. Expanding the force majeure concept to include additional regulatory requirements is beyond the scope of the proposed rule. Therefore, the final rule covers petitions for extensions to performance test deadlines only.

Comment: Four commenters requested that we allow simplified notifications. One of these commenters requested that we allow a simplified notification initially followed by the timeline for completing the performance test later. In addition, one of these commenters requested that we allow initial notification to the Administrator in non-written formats followed by written communication later since during force majeure events means of communication may be disrupted. Two of these commenters stated that the Administrator should not require listing of every applicable test and rule for an entire facility.

Response: We agree that phased notification may be appropriate in certain circumstances. For example, if a source owner or operator is unable to determine a date by which the performance test will be conducted at the time of the force majeure event, verbal notification to the Administrator that the original performance test deadline will be missed followed by written communication describing the details required by the rule may be appropriate. Also, if a force majeure event results in widespread power outages and no U.S. Postal mail service, an initial oral notification followed by written notification may be necessary. The written notification required by this rule does not include a listing of every applicable test and rule for an entire facility. The rule requires the source owner or operator to provide to the permitting authority a written description of the force majeure event, a rationale for attributing the delay in testing beyond the regulatory deadline to the force majeure event, a written description of the measures taken or to be taken to minimize the delay, and a date (as soon as practicable following the force majeure event) by which the owner or operator proposes to conduct the performance test.

Comment: Two commenters requested that we clarify that written notification includes letters, faxes, e-mails, web-based submittals, etc.

Response: We agree that written notification regarding force majeure events can be provided to the Administrator in such written formats as those listed above.

Comment: Three commenters expressed the concern that a legitimate request for an extension may be denied based on the timing of the request. For example, source owners and operators may not be aware of an anticipated hurricane until one day prior to the event. Another commenter suggested that we require source owners and operators to notify the Administrator verbally within five days of the force majeure event and in writing within twenty-one days of the event.

Response: We proposed that the owner or operator would notify the Administrator, in writing, as soon as practicable following the date the owner or operator first knew, or should have known that the event may cause or caused a delay in testing beyond the regulatory deadline. We do not believe that it is appropriate to establish specific timelines in the rule. The existence of a force majeure event typically necessitates flexibility. Thus, the final rule states that the owner or operator shall notify the Administrator, in writing as soon as practicable following the date the owner or operator first knew, or through due diligence should have known that the event may cause or caused a delay in testing beyond the regulatory deadline, but the notification must occur before the performance test deadline unless the initial force majeure or a subsequent force majeure event delays the notice, and in such cases, the notification shall occur as soon as practicable.

Comment: Four commenters suggested that we add a provision that allows requests for extensions to be automatically granted if the Administrator does not respond within a specific timeframe. Three of the four commenters suggested that the Administrator be given thirty days to respond. Two commenters are concerned that owners and operators will be subject to enforcement actions until their requests for extensions are approved.

Response: We disagree with allowing automatic approvals and with requiring the Administrator to respond within 30 days. We do not believe that it is appropriate to place this burden on the Administrator since the Administrator may also have been affected by the force majeure event. We believe that it is appropriate to require the Administrator to notify the owner or operator of approval or disapproval of the request for an extension as soon as practicable. Furthermore, if an owner or operator misses its performance test deadline due to a force majeure event, and the request for an extension is subsequently approved, the owner or operator will not be held in violation for failure to conduct the performance test within the prescribed regulatory timeframe.

Comment: Two commenters stated that circumstances, such as during acts of war, mandatory evacuations, or energy and supply restrictions, applying for an extension to a performance test deadline should be self-implementing.

Response: We believe that the Administrator should have the discretion to determine if a request for an extension warrants approval and that self-implementation is not appropriate. During any situation that a source owner or operator believes qualifies as a force majeure event, the owner or operator must submit a request to the Administrator that includes the required information, such as a written description of the force majeure event, a rationale for attributing the delay in testing beyond the regulatory deadline to the force majeure event, a description of the measures taken to minimize the delay, and a date (as soon as practicable) by which the performance test is expected to occur. The Administrator will notify the owner or operator of approval or disapproval of the request for an extension as soon as practicable. Furthermore, if an owner or operator misses its performance test deadline due to a force majeure event, and the request for an extension is subsequently approved, the owner or operator will not be held in violation for failure to conduct the performance test within the prescribed regulatory timeframe.

Comment: One commenter requested that we add the following statement to the rule (i.e., “the Administrator shall approve a reasonable request for extension of the performance test deadline.”)

Response: We do not believe that it is necessary to add this statement to the rule. The decision as to whether or not to grant an extension to the performance test deadline is solely within the discretion of the Administrator. The Administrator will notify the owner or operator in writing of approval or disapproval of the request as soon as practicable.

Comment: Two commenters requested that EPA affirm that we already have the authority to approve requests for extensions to performance tests.

Response: We do not have this authority except through enforcement discretion. Therefore, we developed this rule to grant this authority.

Comment: Three commenters believe that the Administrator should have the authority to issue blanket approvals for a designated area in advance of a force majeuere event.

Response: We do not believe that blanket approvals are necessary since approvals for requests to extend performance test deadlines can be granted after the force majeure event occurs. Furthermore, we believe that requests to extend performance test deadlines should be reviewed and considered on a case-by-case basis because situations and circumstances may vary among facilities affected by the same force majeure event.

Comment: Four commenters requested that we specify that extensions granted under this rule are not Title V deviations.

Response: We agree that extensions granted under this rule are not Title V deviations since the original performance test deadline will not be applicable once a request for an extension has been approved. However, where the Administrator has not yet issued a decision on a request for an extension under today's rule, the failure to conduct the performance test within the originally prescribed timeframe is a deviation and should be reported as such.

Comment: One commenter requested that we expand the concept of force majeure to cover regulations for other environmental media, such as water regulations.

Response: We proposed that this rule address air regulations only and are maintaining that approach in the final rule.

Comment: One commenter requested that denials for extensions be administratively appealable.

Response: The commenter did not explain why this recommendation is appropriate or how it could be implemented. Therefore, we are not adopting this recommendation.

Comment: One commenter requested that we delete the word “strictly” from the statement “Until an extension of the performance test deadline has been approved under * * *, the owner or operator of the affected facility remains strictly subject to the requirements of this part.”

Response: We disagree with the request to remove the word “strictly” because it is intended to emphasize that this rule is one of strict liability.

This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735 October 4, 1993) and is therefore not subject to review under the EO.

The information collection requirements in this rule have been submitted for approval to the Office of Management and Budget (OMB) under the Paperwork Reduction Act , 44 U.S.C. 3501 et seq. The information collection requirements are not enforceable until OMB approves them.

The final rule requires a written notification only if a plant owner or operator needs an extension of a performance test deadline due to certain rare events, such as acts of nature, acts of war or terrorism, or equipment failure or safety hazard beyond the control of the affected facility. Since EPA believes such events will be rare, the projected cost and hour burden will be minimal.

The increased annual average reporting burden for this collection (averaged over the first 3 years of the ICR) is estimated to total 6 labor hours per year at a cost of $377.52. This includes one response per year from six respondents for an average of 1 hour per response. No capital/startup costs or operation and maintenance costs are associated with the final reporting requirements. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9. When this ICR is approved by OMB, the Agency will publish a technical amendment to 40 CFR part 9 in the Federal Register to display the OMB control number for the approved information collection requirements contained in this final rule.

The Regulatory Flexibility Act generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.

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

After considering the economic impacts of today's final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. Extensions to deadlines for conducting performance tests will provide flexibility to small entities and reduce the burden on them by providing them an opportunity for additional time to comply with performance test deadlines during force majeure events. We expect force majeure events to be rare since these events include circumstances such as, acts of nature, acts of war or terrorism, and equipment failure or safety hazard beyond the control of the affected facility.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. L. 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and Tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including Tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

EPA has determined that the final rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and Tribal governments, in the aggregate, or the private sector in any one year. The maximum total annual cost of this final rule for any year has been estimated to be less than $435.00. Thus, today's final rule is not subject to the requirements of Sections 202 and 205 of the UMRA.

EPA has determined that the final rule contains no regulatory requirements that might significantly or uniquely affect small governments. The final rule requires source owners and operators to provide a written notification to the Agency only if an extension to a performance test deadline is necessary due to rare force majeure events. Therefore, the final rule is not subject to the requirements of section 203 of the UMRA.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), 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 does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. The final rule requirements will not supercede State regulations that are more stringent. In addition, the final rule requires a written notification only if a plant owner or operator needs an extension of a performance test deadline due to certain rare events, such as acts of nature, acts of war or terrorism, or equipment failure or safety hazard beyond the control of the affected facility. Since EPA believes such events will be rare, the projected cost and hour burden will be minimal. Thus, Executive Order 13132 does not apply to this rule.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), 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.” This final rule does not have tribal implications as specified in Executive Order 13175. This final 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.

Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

This final rule is not subject to the Executive Order because it is not economically significant as defined in Executive Order 12866 and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This rule does not affect the underlying control requirements established by the applicable standards but only the timeframe associated with performance testing in limited circumstances.

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) because it is not a significant regulatory action under Executive Order 12866.

As noted in the proposed rule, 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), directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. New test methods are not being proposed in this rulemaking, but EPA is allowing for extensions of the regulatory deadlines by which owners or operators are required to conduct performance tests when a force majeure is about to occur, occurs, or has occurred which prevents owners or operators from testing within the regulatory deadline. Therefore, NTTAA does not apply.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective May 16, 2007.

I. Authority

33 U.S.C. 1251 et seq.; 33 U.S.C. 2720; E.O. 12777 (October 18, 1991), 3 CFR, 1991 Comp., p. 351.

On July 17, 2002, the Agency published a final rule that amended the SPCC regulations ( see 67 FR 47042). The rule became effective on August 16, 2002. The final rule included compliance dates in § 112.3 for preparing amending, and implementing SPCC Plans. The original compliance dates were extended on January 9, 2003 ( see 68 FR 1348), again on April 17, 2003 ( see 68 FR 18890), a third time on August 11, 2004 ( see 69 FR 48794), and a fourth time on February 17, 2006 ( see 71 FR 77266). 1

Under the current provisions in § 112.3(a)(1), the owner or operator of a facility (other than a farm) that was in operation on or before August 16, 2002 must make any necessary amendments to its SPCC Plan and fully implement it by October 31, 2007, while the owner or operator of a facility (other than a farm) that came into operation after August 16, 2002, but before October 31, 2007, must prepare and fully implement an SPCC Plan on or before October 31, 2007. Under the current provision in § 112.3(b)(1), the owner or operator of a facility (other than a farm) that becomes operational after October 31, 2007 must prepare and implement an SPCC Plan before beginning operations. In addition, § 112.3(c) requires onshore and offshore mobile facilities to prepare or amend and implement their SPCC Plans on or before October 31, 2007.

On December 26, 2006, EPA finalized a set of SPCC rule amendments that address certain targeted areas of the SPCC requirements based on issues and concerns raised by the regulated community (71 FR 77266). As highlighted in the EPA Regulatory Agenda and the 2005 OMB report on “Regulatory Reform of the U.S. Manufacturing Sector,” EPA is considering further amendments to address other areas where regulatory reform may be appropriate. For these additional areas, the Agency expects to issue a proposed rule later this year. Areas where regulatory reform may be appropriate include, but are not limited to, oil and natural gas exploration and production facilities, farms, and qualified facilities. Because the Agency was concerned that it would not be able to propose and promulgate such regulatory amendments before the current October 31, 2007 compliance date, EPA believed it appropriate to provide a further extension of the compliance date, and thus, proposed an extension to the compliance dates on December 26, 2006 (71 FR 77357). This notice finalizes that proposal.

This rule extends the dates in § 112.3(a), (b), and (c) by which a facility must prepare or amend and implement its SPCC Plan. As a result of the revisions in § 112.3(a)(1), an owner or operator of a facility (other than a farm) that was in operation on or before August 16, 2002 must make any necessary amendments to his SPCC Plan, and implement that Plan, on or before July 1, 2009. This will allow the owner or operator time to prepare or amend and implement the SPCC Plan in accordance with the July 2002 (67 FR 47042, July 17, 2002) and December 2006 (71 FR 77266, December 26, 2006) amendments, and any subsequent modifications to the SPCC requirements that are promulgated based on amendments that the EPA intends to propose later this year. EPA expects to promulgate such a final rule by the summer of 2008. The facility owner/operator must continue to maintain his existing SPCC Plan until he amends and fully implements the Plan to comply with the revised requirements. Similarly, an owner or operator of a facility (other than a farm) that came into operation after August 16, 2002 through July 1, 2009 must prepare and implement an SPCC Plan on or before July 1, 2009.

Under the revised § 112.3(b)(1), the owner or operator of a facility regulated under the SPCC rule that becomes operational after July 1, 2009 must prepare and implement an SPCC Plan before beginning operations.

This rule similarly extends the compliance dates in § 112.3(c) for mobile facilities. Under this rule, an owner or operator of a mobile facility must prepare or amend and implement an SPCC Plan on or before July 1, 2009, or before beginning operations if operations begin after July 1, 2009.

The Agency believes that such an extension of the compliance dates is appropriate for several reasons. First, this extension will allow those potentially affected in the regulated community an opportunity to make changes to their facilities and to their SPCC Plans necessary to comply with any revised requirements promulgated based on the amendments expected to be proposed later this year, and finalized thereafter, rather than with the existing requirements.

Further, the Agency believes that this extension of the compliance dates will also provide the owner or operator of a facility the time to fully understand the regulatory amendments offered by revisions to the 2002 SPCC rule promulgated on December 26, 2006 (71 FR 77266) and amendments expected to be promulgated by the summer of 2008. 2

In addition, the Agency intends to issue revisions to the SPCC Guidance for Regional Inspectors , to address both the December 2006 revisions and the revisions expected to be proposed later this year. The guidance document is designed to facilitate an understanding of the rule's applicability, to help clarify the role of the inspector in the review and evaluation of the performance-based SPCC requirements, and to provide a consistent national policy on SPCC-related issues. The guidance is available to both the owners and operators of facilities that may be subject to the requirements of the SPCC rule and to the general public on the Agency's Web site at http://www.epa.gov/oilspill . The Agency believes that this extension will provide the regulated community the opportunity to take advantage of the material presented in the revised guidance before preparing or amending their SPCC Plans.

The Agency received 28 submissions on the proposed rule (71 FR 77357, December 26, 2006). The discussion below summarizes and responds to the major comments received. A more complete response to comments document can be found in the docket for this rulemaking, EPA-HQ-OPA-2006-0949.

The majority of commenters (nineteen) supported the proposed extension of the compliance date and generally agreed that the extension would allow the Agency time to promulgate further regulatory revisions. Many commenters also noted that the proposed extension would allow the industries potentially affected by those revisions an opportunity to make the necessary changes to their facilities and to their SPCC Plans to comply with the revised requirements expected to be proposed in 2007 and later finalized.

A second group of commenters (nine) supported the proposed extension, but suggested alternate schedules, arguing that EPA's proposed compliance date was premature given the Agency's intent to propose further changes to the SPCC rule in 2007. Several schedules were suggested:

• Tie the compliance dates to promulgation of the rule finalizing the amendments to be proposed in 2007 or, in the event that EPA decides not to go forward with further modifications to the rule, 12 months after publication of a notice in the Federal Register terminating that rulemaking.

• Provide an extension of 18 months from the promulgation of the final amendments to the SPCC rule, thereby providing adequate time for a regulated facility to implement the amendments (i.e., review amendments, develop and/or modify existing Plans, and comply with any final changes to the rule or guidance).

• Set the date for preparing and amending the SPCC Plans to one year following publication of the final amendments, maintaining the six-month separation between the dates for amending and implementing Plans.

• Set a Plan preparation compliance date of July 1, 2009, and an implementation compliance date of January 1, 2010, thereby allowing a facility owner or operator adequate time after Plan amendment to make changes at his facility, properly train employees on the amended Plan requirements, and allow for full implementation of the amended Plan requirements.

The Agency disagrees with those commenters who suggested an alternate schedule to either set uncertain compliance dates in § 112.3 or to further extend the time period for the compliance dates. While the Agency recognizes that a regulated facility owner or operator needs adequate time after EPA takes final action on the proposed amendments to the SPCC Plan requirements to amend or prepare an SPCC Plan and to implement it, we also believe that one year is a reasonable period of time to allow for preparing, amending, and implementing an SPCC Plan following final Agency action on the proposed amendments to the SPCC rule. The Agency intends to develop and publish Federal Register notices proposing and then taking final action on further amendments to the SPCC regulatory requirements as soon as possible. At this time, based on the information at hand, the Agency believes that extending the compliance dates in § 112.3 until July 1, 2009 will allow owners and operators an adequate interval to comply with the SPCC rule.

The Agency also disagrees with commenters who requested a revised date for implementing amended SPCC Plans to include a six-month period after the July 1, 2009 date for Plan amendment. For the reasons discussed above, the Agency believes that the July 1, 2009 date for both Plan amendment and implementation is more than adequate. The effect of the Agency's decision to eliminate the gap between Plan preparation or amendment and implementation was to provide additional time for the owner or operator to prepare or amend the SPCC Plan. The Agency believes that this approach, which allows an owner or operator flexibility in scheduling Plan development or amendment, makes sense given that an owner or operator is not required to submit his SPCC Plans to the Agency. It also simplifies the burden for an owner or operator of an SPCC facility by establishing a single compliance date, while providing additional time for Plan development.

One commenter opposed a compliance date extension for this regulation, arguing that it was not effectively addressing the problems with the regulation, and that the best way to do this would be by completing a complete re-write of the rule. First, the Agency disagrees with the commenter that the SPCC regulation needs to be re-written. Rather, the Agency believes that it is in the best interest of the regulated community to address areas of confusion that arose after promulgation of the 2002 amendments, and that promulgating a proposal intended to clarify and tailor requirements, particularly for small businesses, and making revisions to the SPCC Guidance for Regional Inspectors available to the regulated community will ultimately result in a more effective and complete implementation of the SPCC regulation and in enhanced environmental protection. The Agency also believes that the regulated community needs the additional time allowed by the extension in order to better take advantage of the guidance and any further amendments that are promulgated and that the benefits of this extension outweigh the concerns raised by the opposing commenter. Furthermore, a facility owner or operator subject to the SPCC rule continues to be required to ensure that operations are conducted in a manner that safeguards human health and the environment by preventing oil discharges to navigable waters and adjoining shorelines and by effectively responding in the event of an accidental discharge.

In the December 2006 final rule amendments, EPA finalized an extension of the compliance dates for the owner or operator of a farm (71 FR 77266), as defined in § 112.2, to prepare or amend and implement the farm's SPCC Plan until the effective date of a rule that establishes SPCC requirements specifically for farms or otherwise establishes dates by which farms must comply with the provisions of the SPCC rule. The Agency has been conducting additional information collection and analyses to determine if differentiated SPCC requirements may be appropriate for farms. Specifically, the Agency has been working with the U.S. Department of Agriculture, as well as the farming community, to collect data that would more accurately characterize oil storage and handling at these facilities. These efforts will allow the Agency to better focus on priorities where substantial environmental improvements can be obtained. The Agency will propose the new compliance dates for farms in a separate Federal Register notice. Today's rule does not affect this extended compliance date for farms.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action has been determined to be a “significant regulatory action.” This final rule would extend the compliance dates in § 112.3, but would have no other substantive effect. However, because of its interconnection with the related SPCC rule amendments finalized on December 26, 2006 (71 FR 77266) which was a significant action under the terms of Executive Order 12866, and because of the upcoming proposal to further amend the SPCC requirements, this action was submitted to OMB for review.

This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq ).

The Regulatory Flexibility Act generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. Small entity is defined as: (1) A small business as defined in the Small Business Administration's (SBA) regulations at 13 CFR 121.201—the SBA defines small businesses by category of business using North American Industry Classification System (NAICS) codes, and in the case of farms and oil exploration and production facilities, which constitute a large percentage of the facilities affected by this rule, generally defines small businesses as having less than $500,000 in revenues or 500 employees, respectively; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise that is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's rule on small entities, the Agency concludes that this action would not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives “which minimize any significant economic impact of the rule on small entities.” 5 U.S.C. 603 and 604. Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on the small entities subject to the rule.

This rule would defer the regulatory burden for small entities by extending the compliance dates in § 112.3. After considering the economic impacts of today's rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives, and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted.

Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with a significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

EPA has determined that this rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. EPA also has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. As was explained above, the effect of this action would be to reduce burden and costs for owners and operators of all facilities, including small governments that are subject to the rule.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), 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 rule does not have federalism implications. It would 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. Under CWA section 311(o), States may impose additional requirements, including more stringent requirements, relating to the prevention of oil discharges to navigable waters. EPA recognizes that some States have more stringent requirements (56 FR 54612, (October 22, 1991). This rule would not preempt State law or regulations. Thus, Executive Order 13132 does not apply to this rule.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), 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.” This final rule does not have tribal implications, as specified in Executive Order 13175. Today's rule would not significantly or uniquely affect communities of Indian Tribal governments. Thus Executive Order 13175 does not apply to this rule.

Executive Order 13045: “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe my have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

This final rule is not subject to the Executive Order because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children.

This rule is not a “significant energy action” as defined in Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

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) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards, such as materials specifications, test methods, sampling procedures, and business practices that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

This rule does not involve technical standards. Therefore, NTTAA does not apply.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective May 16, 2007.

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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

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 .

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-2005-EPA-0121 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 July 16, 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-2005-EPA-0121, 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.

In the Federal Register of May 25, 2005 (70 FR 30105) (FRL-7713-1). EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 4F6877) by Biopreparaty, Co. Ltd. Tylisovska I, Prague 6, Czech Republic. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement Pythium oligandrum DV 74. This notice included a summary of the petition prepared by the petitioner Biopreparaty Co. Ltd.

One comment was received from a private citizen opposing the “production or selling” of Pythium oligandrum DV 74. The commentor further stated that it was their wish that no exemptions be issued and that no tolerances should be approved. The Agency understands the commentor's concerns and recognizes that some individuals believe that pesticides should be banned completely. However, under the existing legal framework provided by section 408 of the FFDCA EPA is required to establish pesticide tolerances or exemptions where persons seeking such exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. The commentor has not provided the Agency with a specific rationale or additional information pertaining to the legal standards in FFDCA section 408 for opposing the establishment of a tolerance exemption for Pythium oligandrum DV 74. In the absence of any additional information of a factual nature, the Agency can not effectively respond to the commentor's disagreement with the Agency's decision.

Another comment was received that supported the registration. The commentator stated that “ Pythium oligandrum appears to be an unusually effective (in its rapidity of action) and exceptionally safe (in terms of mammalian toxicity) crop protection product.”

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 exemption 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. Pursuant to section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C), which require 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. . . . ” Additionally, section 408(b)(2)(D) of the FFDCA requires that the Agency consider “available information concerning the cumulative effects of a particular pesticide's residues ” and “other substances that have a common mechanism of toxicity.”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

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.

A guideline acute oral toxicity study was carried out in 2001 using mice. Ten mice (five males, five females) were given a total dose of 5,000 milligrams/kilogram (mg/kg) Pythium oligandrum DV 74 and no adverse effects were seen in the mice which were observed for 14 days after dosing. The test substance was rated Toxicity Category IV .

A guideline acute dermal toxicity study was conducted using rats. The dermal LD 50 for males, females, and combined was greater than 5,000 mg/kg body wt. Pythium oligandrum DV 74 test substance was rated Toxicity Category IV .

In a four-hour acute inhalation toxicity study using rats, a limit dose (5 mg/L) of Pythium oligandrum DV 74 produced no mortality nor adverse effects, and no gross abnormalities were seen at necropsy 14 days later. Although the MMD was 7.45 and µm, approximately 68% of the particles were ≤3.75 µm. The acute inhalation LC 50 for males, females, and combined was >5 mg/L for a 4 hour exposure. The test substance is Toxicity Category IV .

In a four-hour acute inhalation toxicity study using rats, a limit dose (5 mg/L) of Pythium oligandrum DV 74 produced no mortality or adverse effects, and no gross abnormalities were seen at necropsy 14 days later. Although the MMD was 7.45 µm, approximately 68% of the particles were ≤3.75 µm. The acute inhalation LC 50 for males, females, and combined was >5 mg/L for a 4 hour exposure. The test substance is classified as Toxicity Category IV . Infectivity testing was waived for this study based on the results of the growth temperature study which showed no growth on plant-based growth media at or above 37° C, and no growth at any temperature on animal tissue-based growth media.

An acute injection toxicity/pathogenicity study was conducted using rats. Storage, stability data showed that after Batch No. 150405 was stored for approximately 9 months, of 1.3x10 6 oospores/g active ingredient 80.5% were viable after 120 hours incubation, giving 1.1x10 6 cfu/g - however, this study lists Batch No. 150405 as containing 10 7 granules/g, so viability would then be only 11%. Based on the data submitted, Pythium oligandrum DV 74 does not appear toxic nor pathogenic to rats when dosed at 2.9x10 4 oospores/animal - although no attempts to isolate viable organisms prior to testing, or from test animals after inoculation, were made. Therefore, infectivity cannot be assessed in the study, initially rated not toxic nor pathogenic. In addition, there were discrepancies with characterization of the test substance. However, infectivity testing was waived for this study, based on the results of the growth temperature study which showed no growth on plant-based growth media at or above 37° C, and no growth at any temperature on animal tissue-based growth media.

An acute dermal irritation study was conducted using rabbits. Very slight erythema was noted on the skin of three rabbits one hour after patch removal, with clearance on two rabbits by 24 hours and on one rabbit by 48 hours. The primary irritation index was 0.3. Technical DV 74 was essentially nonirritating; the test substance was rated Toxicity Category IV .

An acute eye irritation study was conducted using rabbits. No corneal opacity nor iritis was observed during the study. Positive conjunctival irritation (score 2) was noted on 2 rabbits 1 hour after Pythium oligandrum DV 74 instillation with resolution by 48 hours. The maximum average score was 6.7 at 24 hours after test material instillation. The test substance is Toxicity Category III .

A guideline acute dermal toxicity study was conducted using rats. The dermal LD 50 for males, females, and combined was greater than 5,000 mg/kg body wt. Pythium oligandrum DV 74 and rated Toxicity Category IV . An acute dermal irritation study was conducted using rabbits. Very slight erythema was noted on 3/3 rabbits one hour after patch removal, with clearance on two rabbits by 24 hours and on one rabbit by 48 hours. The primary irritation index was 0.3. Technical DV 74 was essentially nonirritating and rated Toxicity Caterogy IV . In addition, Pythium oligandrum occurs naturally in a variety of soil types over a wide range of environmental conditions. Although application of Pythium oligandrum DV 74 to seeds, foliage, or soil will likely temporarily increase its concentration in the environment, the population is expected to subside to normal levels, because the organism does not thrive in the absence of sufficient nutrients. A search of the public literature found no reports of Pythium oligandrum having adverse effects in humans or other mammals. The only known biological effects of Pythium oligandrum are parasitic effects on fungal species and stimulation of resistance to parasitic infection in plants. Neither the mechanism of the mycoparasitic action nor the stimulation of plant resistance is associated with adverse effects in mammals. Pythium oligandrum DV 74 is the active ingredient in various over-the-counter products sold in Europe, including a mouthwash, a bath additive and a skin cream. These products have been on the market in parts of the EU since 1999 with no reported adverse effects. The lack of any reported sensitization effects from repeated dermal exposure to the consumer products suggests that Pythium oligandrum is not a dermal sensitizer. To reduce exposure to this active ingredient from its pesticide use, the agricultural use label requires that applicators and handlers wear a long-sleeved shirt and long pants, waterproof gloves, and shoes plus socks.

Pythium oligandrum DV 74 is primarily a fungal hyperparasite that exhibits limited growth on plant-based media and no growth on animal tissue-based media. In addition, its growth tapers off as temperature approaches normal human body temperature of 37° C and there is no growth at or above this temperature. Therefore, infectivity testing is not possible. This information supports waivers for infectivity testing in the acute oral, acute dermal, acute inhalation, and injection exposure studies.

Based on the data generated in accordance with Tier I data requirements (40 CFR 158.740(c)), Tier II tests (Guidelines 152B-40 through 152B-49), which include acute oral, acute inhalation, subchronic oral, acute intraperitoneal/intracerebral, primary dermal, primary eye, immune response, teratogenicity, virulence enhancement, and mammalian mutagenicity were not required. Tier III tests (Guidelines 152-50 through 53), which include chronic testing, oncogenicity testing, mutagenicity, and teratogenicity were also not required.

EPA is required under section 408(p) of the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “humans that is similar to an effect produced by a naturally-occurring estrogen, or other such endocrine effects as the Administrator may designate.” Pythium oligandrum is not a known endocrine disruptor nor is it related to any class of known endocrine disruptors. Consequently, endocrine-related concerns did not adversely impact the Agency's safety finding for Pythium oligandrum .

In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

Due to the proposed use of Pythium oligandrum on food crops, fungal residues may be present on agricultural commodities. However, negligible to no risk is expected for the general population, including infants and children, because Pythium oligandrum demonstrated no pathogenicity nor acute oral toxicity at the maximum doses tested.

1. Food . Due to the proposed use of Pythium oligandrum on food crops, fungal residues may be present on agricultural commodities. However, negligible to no risk is expected for the general population, including infants and children, because Pythium oligandrum demonstrated no pathogenicity or oral toxicity at the maximum doses tested.

2. Drinking water exposure . Pythium oligandrum does not thrive in aquatic environments and there are no aquatic use sites for the pesticide. Accordingly, application of this pesticide to approved use sites is not expected to increase drinking water exposure to Pythium oligandrum . Furthermore, any Pythium oligandrum that might be consumed through drinking water would pose negligible to the general population, including infants and children, due to the pesticide's low toxicity classification.

Pythium oligandrum will be applied to agricultural fields, turf and professional landscapes, and in home gardens. Although some applications may be made near residential areas, no harm would be expected to result from exposure to Pythium oligandrum due to its low toxicity classification.

1. Dermal exposure . Dermal exposure is limited by use of the required PPE and REI in occupational settings, and residential users are advised to avoid skin contact and to wash any exposed skin or clothing.

2. Inhalation exposure . The greatest likelihood of inhalation exposure would occur in an occupational setting, among mixers/loaders and applicators. However, as demonstrated in the acute pulmonary toxicity/pathogenicity test, Pythium oligandrum is not infective, pathogenic, or toxic to mammals. Despite the benign nature of the active ingredient, the agency requires that all workers exposed to microbial pesticides must wear a dust/mist filtering respirator. As such, the risks anticipated for inhalation exposure are minimal.

Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to consider the cumulative effect of exposure to Pythium oligandrum and to other substances that have a common mechanism of toxicity. These considerations include the possible cumulative effects of such residues on infants and children. As demonstrated in Unit III.A., Pythium oligandrum is not toxic or pathogenic to mammals, and only minimally irritating to eyes. Consequently, no cumulative effects from the residues of this product with other related microbial pesticides are anticipated.

There is a reasonable certainty that no harm to the U.S. population, including infants and children, will result from aggregate exposure to residues of Pythium oligandrum due to its use as a microbial pest control agent. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. As discussed in Unit III.A., Pythium oligandrum is not toxic or pathogenic to mammals, and only minimally irritating in an eye exposure study. Accordingly, exempting Pythium oligandrum from the requirement of a tolerance is considered safe and poses no significant risks.

FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold margin of exposure (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 that a different margin of exposure (safety) will be safe for infants and children. Margins of exposure (safety), which often are referred to as uncertainty factors, are incorporated into EPA risk assessment either directly or through the use of a margin of exposure analysis or by using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk. Actual exposures to adults and children through diet are expected to be several orders of magnitude less than the doses used in the toxicity and pathogenicity tests referenced in Unit III. Thus, the Agency has determined that an additional margin of safety for infants and children is unnecessary.

EPA is required under section 408(p) of the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “may have an effect in humans that is similar to an effect produced by a naturally-occurring estrogen, or other such endocrine effects as the Administrator may designate.” Pythium oligandrum is not a known endocrine disruptor nor is it related to any class of known endocrine disruptors. Consequently, endocrine-related concerns did not adversely impact the Agency's safety finding for Pythium oligandrum .

The acute oral toxicity and pathogenicity findings discussed in Unit III demonstrate that the active ingredient does not pose a dietary risk. Nevertheless, the Agency has concluded that for the analysis of the pesticide itself, microbiological and biochemical methods exist and are acceptable for the enforcement purposes for product identity of Pythium oligandrum DV 74. Other appropriate methods are required for quality control to assure that product characterization, the control of human pathogens, and other unintentional metabolites or ingredients are within regulatory limits, and to ascertain storage stability and viability of the pesticidal active ingredient.

There is no established Codex maximum residue level for residues of Pythium oligandrum DV 74.

The results of the studies discussed are sufficient to comply with the requirements of FQPA. They support an exemption from the requirement of tolerance for residues of Pythium oligandrum DV 74, on treated food of food commodities. In addition, the Agency is of the opinion that, if the microbial active ingredient is used as allowed, aggregate and cumulative exposures are not likely to pose any undue hazard to the U.S. population of adult, children, and infant humans. Therefore, an exemption from the requirement of tolerance is granted in response to pesticide petition 4F6877.

This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

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

This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

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).

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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions discussed above. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

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 .

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-2006-0800 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 July 16, 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-2006-0800, 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.

In the Federal Register of October 13, 2006 (71 FR 198) (FRL-8096-2), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6G7089) by E I. DuPont de Nemours and Company, DuPont Crop Protection, 1090 Elkton Road, Newark, Delaware 19711. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide chlorantraniliprole, 3-bromo- N -[4-chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, in or on apple at 0.3 parts per million (ppm), apple, celery at 7.0 ppm, cucumber at 0.09 ppm, lettuce, head at 4.0 ppm, lettuce, leaf at 7.5 ppm, pear at 0.30 ppm, pepper at 0.50 ppm, spinach at 13.0 ppm, squash at 0.25 ppm, tomato at 0.30 ppm and watermelon at 0.20 ppm. This notice referenced a summary of the petition prepared by E.I. DuPont de Nemours and Company, DuPont Crop Protection, the registrant, which has been included in the public docket. Several comments were received from a private citizen on objecting to pesticide body load, IR-4 profiteering, animal testing, and other related matters. The Agency has received these same comments from this commenter on numerous previous occasions. Refer to the Federal Register of June 30, 2005 (70 FR 37686) (FRL-7718-3), January 7, 2005 (70 FR 1354) (FRL-7691-4), and October 29, 2004 69 FR 63096 for the Agency's response to these objections.

These temporary tolerances will permit the marketing of the above raw agricultural commodities when treated in accordance with the provisions of the experimental use permits 352-EUP-170, and 353-EUP-171, which are being issued under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136).

The scientific data reported and other relevant material were evaluated, and it was determined that establishment of these temporary tolerances will protect the public health. Therefore, these temporary tolerances have been established on the condition that the pesticide be used in accordance with the experimental use permits. The tolerances will expire on May 1, 2010.

Section 408(b)(2)(A)(i) of the 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 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 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 .

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. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA , for tolerances for residues of chlorantraniliprole on apple at 0.25 ppm, apple, wet pomace at 0.60 ppm, celery at 7.0 ppm, cucumber at 0.10 ppm, lettuce, head at 4.0 ppm, lettuce, leaf at 8.0 ppm, pear at 0.30 ppm, pepper at 0.50 ppm, spinach at 13.0 ppm, squash at 0.40 ppm, tomato at 0.30 ppm and watermelon at 0.20 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the toxic effects caused by chlorantraniliprole 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 www.regulations.gov in Docket ID EPA-HQ-OPP-2006-0800.

For hazards that have a threshold below which there is no appreciable risk, the dose at which 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 http://www.epa.gov/pesticides/health/human.htm .

A summary of the toxicological endpoints for chlorantraniliprole used for human risk assessment can be found at www.regulations.gov in Docket ID EPA-HQ-OPP-2006-0800.

1. Dietary exposure from food and feed uses. Chlorantraniliprole is a new active ingredient and tolerances have not been established. A risk assessment was conducted by EPA to assess dietary exposures from chlorantraniliprole in food (from crops treated under the experimental permits) 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. Acute dietary (food and drinking water) exposure assessments were conducted for chlorantraniliprole using the Dietary Exposure Evaluation Model (DEEM-FCID), and reflect the proposed uses on apple, celery, cucumber, head and leaf lettuce, pear, pepper, spinach, squash, tomato and watermelon crops. The modeled exposure estimates are based on tolerance level residues (calculated using the maximum residue level calculator) assuming 100% of crops are treated and surface water estimated drinking water concentrations (EDWCs) (because surface water EDWCs were higher than ground water EDWCs).

ii. Chronic exposure . Chronic dietary (food and drinking water) exposure assessments were conducted for chlorantraniliprole using the DEEM-FCID), and reflect the proposed uses on apple, celery, cucumber, head and leaf lettuce, pear, pepper, spinach, squash, tomato and watermelon crops. The modeled exposure estimates are based on tolerance level residues (calculated using the maximum residue level calculator) assuming 100% of crops are treated and surface water estimated drinking water concentrations (EDWCs) (because surface water EDWCs were higher than ground water EDWCs).

iii. Cancer . Long-term exposure is not expected to result from use under these Experimental Use Permits (EUPs). The submitted subchronic studies in mice, dog and rats, and the in vivo and in vitro genotoxicity studies, identified no tumors or preneoplastic foci, nor did they identify mutagenic concern. Therefore, the expected short/intermediate-term exposure resulting from the EUPs does not indicate a concern for carcinogenicity.

2. Dietary exposure from drinking water . Clorantraniliprole is an unregistered chemical, thus, the Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for chlorantraniliprole 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 chlorantraniliprole. 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 EPA's pesticide root zone model/exposure analysis modeling system (PRZM/EXAMS) and screening concentration in groundwater (SCI-GROW) models, the estimated environmental concentrations (EECs) of chlorantraniliprole for acute exposures are estimated to be 14 ppb for surface water and 0.38 ppb for ground water. The EECs for chronic exposures are estimated to be 2.3 ppb for surface water and 0.38 for ground 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).

Chlorantraniliprole 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 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 chlorantraniliprole and any other substances and chlorantraniliprole 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 chlorantraniliprole 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/.

1. In general . 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 on toxicity and exposure unless EPA determines 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 margin of exposure (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity . There were no effects on fetal growth or development up to the limit dose of 1,000 milligrams killogram day (mg/kg/day) in rats or rabbits. There were no treatment related effects on the numbers of litters, fetuses (live or dead), resorptions, sex ratio, or post-implantation loss. There were no effects on fetal body weights, skeletal ossification, and external, visceral, or skeletal malformations or variations.

3. Conclusion . Due to the following, the FQPA Safety Factor does not need to be retained at this time:

The toxicology database is complete for the characterization of potential prenatal and postnatal risks to infants and children. No susceptibility was identified in the toxicological data base, and there are no residual uncertainties re: prenatal and/or postnatal exposure (i.e., the developmental and reproduction studies report no adverse effects related to treatment ≥ 1,000 mg/kg/day limit dose). Therefore, a degree of concern analysis for prenatal and/or postnatal susceptibility is not necessary.

Highly conservative dietary (food and water) exposure estimates are at least 60,000 times lower than the highest dose tested in the mammalian toxicity studies (at which no adverse observed effects were seen).

1. Acute/chronic risk . Aggregating routes and/or pathways of exposure is not relevant, since no hazard was identified via any route of exposure in the EUP toxicology data base.

2. Short/Intermediate-term risk . Chlorantraniliprole is not registered for use on any sites that would result in short and intermediate residential exposure and therefore no risk assessment was conducted for this scenario.

3. Aggregate cancer risk for U.S. population . Long-term exposure is not expected to result from use under these EUPs. The submitted subchronic studies in mice, dog and rats, and the in vivo and in vitro genotoxicity studies, identified no tumors or preneoplastic foci, nor did they identify mutagenic concern.

4. 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 chlorantraniliprole residues.

LC/MS/MS methods are available for measuring chlorantraniliprole in plants and livestock. The registrant submitted an LC/MS/MS method for the determination of chlorantraniliprole in plants, and an LC/MS/MS method for the determination of chlorantraniliprole and its metabolites in livestock.

Adequate method and concurrent recovery data were provided for the plant LC/MS/MS method, and the fortification levels used in the method and concurrent validation are adequate to bracket the residue levels determined in the proposed crops. An analytical method for enforcing tolerances in livestock commodities is not germane to this EUP as tolerances in meat, milk, poultry and eggs are not required.

There are currently no established Codex, Canadian, or Mexican MRLs for chlorantraniliprole.

None.

Therefore, time-limited tolerances are established for residues of chlorantraniliprole, 3-bromo- N -[4-chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, in or on apple at 0.25 ppm, apple, wet pomace at 0.60 ppm, celery at 7.0 ppm, cucumber at 0.10 ppm, lettuce, head at 4.0 ppm, lettuce, leaf at 8.0 ppm, pear at 0.30 ppm, pepper at 0.50 ppm, spinach at 13.0 ppm, squash at 0.40 ppm, tomato at 0.30 ppm and watermelon at 0.20 ppm. These tolerances will expire on May 1, 2010.

This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

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

This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

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).

(b) Section 18 emergency exemptions. [Reserved]

(c) Tolerances with regional registrations. [Reserved]

(d) Indirect or inadvertent residues . [Reserved]

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

• Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

• Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

• Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

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

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr .

Under section 408(g) of the FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0995 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before July 16, 2007.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2006-0995, 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.

In the Federal Register of January 24, 2007 (72 FR 3130) (FRL-8109-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F7149) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528. The petition requested that 40 CFR 180.361 be amended by establishing a tolerance for combined residues of the herbicide, pendimethalin [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine] and its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol, in or on beans; beans, forage; beans, hay; and peas (except field peas) each at 0.1 parts per million (ppm). That notice referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available to the public in the docket, http://www.regulations.gov . There were no comments received in response to the notice of filing.

These proposed tolerances seek to correct an inadvertent error made by EPA in 2001 when EPA amended the pendimethalin beans and peas tolerances following completion of the pendimethalin reregistration eligibility determination under the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq ., and FFDCA tolerance reassessment. (66 FR 63192, December 5, 2001). In an attempt to clarify the coverage of the then existing beans and peas tolerances, EPA mistakenly narrowed the scope of the existing tolerances. This action re-establishes the beans and peas tolerances with the same coverage that pre-dated the 2001 amendments and using the terms originally recommended by the tolerance reassessment decision. Specifically, the proposed amendments to the pendimethalin tolerance would replace the current tolerances for bean, lima, seed; bean, lima, succulent; bean, forage; bean, hay; with tolerances for beans; beans, forage; beans, hay and the current tolerance for pea, succulent with a tolerance for peas (except field peas). The terms beans and peas are defined under 40 CFR 180.1(g) to encompass bean and pea commodities not covered by the current tolerances.

Section 408(b)(2)(A)(i) of the 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 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 a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” These provisions were added to the FFDCA by the Food Quality Protection Act (FQPA) of 1996.

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerance for combined residues of pendimethalin and its metabolite on beans; beans, forage; beans, hay; and peas (except field peas) each at 0.1 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by pendimethalin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov . The referenced document is available in the docket established by this action, which is described under ADDRESSES , and is identified as EPA-HQ-OPP-2006-0995 in that docket.

For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors (UF) are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. Short-, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (MOE) called for by the product of all applicable uncertainty/safety factors is not exceeded.

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .

A summary of the toxicological endpoints for pendimethalin used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of April 12, 2006 (71 FR 18628) (FRL-7770-4).

1. Dietary exposure from food and feed uses . In evaluating dietary exposure to pendimethalin, EPA considered exposure under the petition for tolerances as well as all existing pendimethalin tolerances in (40 CFR 180.361). EPA assessed dietary exposures from pendimethalin in food as follows:

i. Acute exposure . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

No such effects were identified in the toxicological studies for pendimethalin; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues.

iii. Cancer . Pendimethalin is classified “Group C”, possible human carcinogen, chemical based on a statistically significant increased trend and pair-wise comparison between the high dose group and controls for thyroid follicular cell adenomas in male and female rats. The Agency used a non-quantitative approach (i.e., non-linear, RfD approach) since mode of action studies are available that demonstrate that the thyroid tumors are due to a thyroid-pituitary imbalance, and also since pendimethalin was shown to be non-mutagenic in mammalian somatic cells and germ. The chronic risk assessment is considered to be protective of any cancer effects; therefore, a separate quantitative cancer aggregate risk assessment is not required.

iv. Anticipated residue and percent crop treated (PCT) information . Tolerance level residues were assumed for all food commodities with current and proposed pendimethalin tolerances, and it was assumed that all of the crops included in the analysis were treated (i.e. 100% crop treated).

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for pendimethalin in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of pendimethalin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm .

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentrations in Groundwater (SCI-GROW) models, the estimated environmental concentrations (EECs) of pendimethalin for peak exposures are estimated to be 39 parts per billion (ppb) for surface water and 0.024 ppb for ground water. The EECs for chronic exposures are estimated to be 4.8 ppb for surface water and 0.024 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 39 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).

Pendimethalin is currently registered for the following residential non-dietary sites: Landscape, grounds plantings, ornamental crops, turf grass, and lawns. EPA assessed residential exposure using the following assumptions: Exposures are short-term in duration, and consist of dermal (for adults and children), and oral (hand-to-mouth, object-to-mouth, and soil ingestion, for children only). The Agency combines risk values resulting from separate exposure scenarios when it is likely they can occur simultaneously, based on the use-pattern and the behavior associated with the exposed population. The LOC for oral, dermal and inhalation exposure is an MOE of less than 300. The residential exposure estimate for adults, consisting of dermal exposure only, results in a total MOE of 740, and is therefore not of concern. The residential exposure for children results in a total MOE (dermal + oral) of 410 at an application rate of 2 lb ai/acre, and an MOE of 400 for an application rate of 3 lb ai/acre. Residential aggregate exposure is not of concern.

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 pendimethalin and any other substances and pendimethalin 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 pendimethalin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative .

1. In general . Section 408 of FFDCA provides that EPA shall apply an additional (10X) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the 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. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional uncertainty/safety factors and/or special FQPA safety factors, as appropriate.

2. Prenatal and postnatal sensitivity . The database for pendimethalin does not indicate a potential for increased toxicological sensitivity from either prenatal or postnatal exposures.

3. Conclusion . In September 2006 we said the following: There was no evidence of qualitative or quantitative susceptibility in the submitted data. Additionally, exposure estimates are based on very conservative data and assumptions that will overstate exposure to pendimethalin. There is, however, a concern that perturbation of thyroid homeostasis may lead to hypothyroidism, and possibly result in adverse effects on the developing nervous system. Since thyroid toxicity parameters were not measured in the developmental toxicity studies, the Agency has requested a developmental thyroid assay be conducted to evaluate the impact of pendimethalin on thyroid hormones, structure, and/or thyroid hormone homeostasis during development. The Agency has retained the additional 10X FQPA safety factor in the form of a database uncertainty factor (UF[DB]) for the lack of the study, to be applied in determining pendimethalin risks.

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-, 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 . No toxic effects attributable to a single dose were identified for pendimethalin. Therefore, an acute risk assessment is not warranted for this chemical.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to pendimethalin from food and water will utilize 26% of the cPAD for the population group children 1-2. Based the use pattern, chronic residential exposure to residues of pendimethalin 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).

Pendimethalin 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 pendimethalin.

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 580 for adult males, 520 for adult females, 310 for children for an application rate of 2 lbs ai/acre to residential turf, and 300 for children for an application rate of 3 lbs ai/acre to residential turf.

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). Based on currently requested uses, there are no scenarios that are likely to result in intermediate-term exposure (30 to 180 days, continuous. Therefore, an intermediate-term risk assessment was not conducted.

5. Aggregate cancer risk for U.S. population . The Agency classifies pendimethalin as a “Group C” (possible human) cancinogen based on thyroid follicular cell adenomas in rats. A non-quantitative approach, non-linear RfD approach is used to assess the cancer risk using a chronic assessment, which is considerated protective of any cancer effects: Because exposure to pendimethalin does not exceed the chronic RfD, pendimethalin is not expected to pose a cancer risk.

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

Enforcement analytical methods using gas chromatography and an electron capture detector are available in the Pesticide Analytical Manual, Volume II.

There are no established or proposed Codex Maximum Residue Levles (MRLs) for pendimethalin residues. Therefore, there are no questions of compatibility with respect to Codex MRLs and U.S. tolerances.

There were no responses to the Notice of Filing for the requested tolerance in beans and peas.

Therefore, the tolerance is established for combined residues of pendimethalin [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine] and its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol, in or on beans; beans, forage; beans, hay; and peas (except field peas) all at 0.1 ppm each.

This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

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

This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

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).

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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Section 5 of FIFRA and the regulations promulgated to carry out that provision of FIFRA (40 CFR part 172). If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

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 .

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-2007-0160 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 July 16, 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-2007-0160, by one of the following methods.

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

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

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

In the Federal Register of March 21, 2007 (72 FR 13277-13279) (FRL-8117-4), 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 tolerance petition (PP 6F7121) by Acta Group, 1203 Nineteenth St., NW., Suite 300, Washington, DC 20036-2401 on behalf of Circle One Global, Inc. P.O. Box 28, Shellman, GA 39886-0028. The petition requested that 40 CFR part 180 be amended to include a temporary exemption from the requirement of a tolerance for residues of Aspergillus flavus NRRL 21882 on corn. This notice included a summary of the petition prepared by the petitioner Acta Group, on behalf of Circle One Global, Inc. No comments were received in response to the Federal Register Notice.

Section 408(c)(2)(A)(i) of 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 exemption is “safe.” Section 408(c)(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. Pursuant to section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C), which require 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. . . .” Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency consider “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

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 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.

Aspergillus flavus NRRL 21882 is a non-aflatoxin-producing fungal active ingredient that will be used to displace the ubiquitous Aspergillus flavus group of microbes, many of which can produce aflatoxin, a potent carcinogen. The toxicological profile of this conditionally registered active ingredient has been previously described in the final rule of the Federal Register of June 30, 2004, (69 FR 39341) (FRL-7364-2). On the basis of those studies, the exemption from tolerance of Aspergillus flavus NRRL 21882, a non-aflatoxin-producing strain of Aspergillus flavus , on peanuts was established in 40 CFR 180.1254.

The acute toxicology oral studies placed Aspergillus flavus NRRL 21882 in Toxicity Category IV. This active ingredient was not toxic, infective or pathogenic to mammals on the basis of acute oral, pulmonary and intraperitoneal studies. That database supporting the exemption from tolerance on peanut also supports the proposed temporary exemption of this active ingredient on corn. For a summary of the studies and discussions of dietary and non-dietary, non-occupational dermal and inhalation exposures, as well as aggregate and cumulative, exposures, and potential endocrine effects refer to the aforesaid June 30, 2004 final rule. All studies met the safety standards of the Food Quality Protection Act of 1996. This pesticide has been used for more than a decade in experimental laboratory and field trials without any reports of adverse dermal irritation or hypersensitivity effects.

The petitioner is now requesting that those studies be also used as the basis to amend the tolerance exemption to include a temporary exemption from tolerance for Aspergillus flavus NRRL 21882 on corn during the Experimental Use Permit with EPA Registration Number (EPA Reg. No.) 75624-EUP-2. The proposed two-year, non-crop destruct Experimental Use Permit is for treatment of approximately 6,000 acres of corn grown for grain in Texas at ten or 20 pounds of the End-use Product (EP) aflaguard R per acre.

The Agency has determined that the studies do support the proposed exemption from tolerance of Aspergillus flavus NRRL 21882 on corn. Summaries of the rationales for this determination may be found in the aforesaid Federal Register Final Rule of June 30, 2004. No further toxicological data are required for this temporary exemption from the requirement of a tolerance for Aspergillus flavus NRRL 21882 on corn. The applicant must, however, report any incidents of hypersensitivity, or any other adverse effects to comply with the requirements of Section 6(a)(2). Efficacy data to demonstrate that the pesticide does reduce aflatoxin-producing Aspergillus flavus colonies and, concomitantly, aflatoxin in corn, are required as part of the Experimental Use Permit.

In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

1. Food . The aforesaid final rule for the exemption from tolerance for residues of Aspergillus flavus NRRL 21882 on peanut considered all studies submitted by the applicant and found them to be acceptable.

2. Drinking water exposure . Those data are also acceptable to demonstrate that the proposed use of Aspergillus flavus NRRL 21882 on corn will not harm the U.S. adult, infant and children population from dietary exposure, including food, and drinking water. Percolation through the soil and municipal treatment of drinking water are expected to preclude exposure of the US population, infants and children to residues of the pesticide.

1. Dermal exposure . Dermal non-occupational exposure is expected to be minimal to non-existent for the proposed use of Aspergillus flavus NRRL 21882 on corn. The pesticide is to be applied to agricultural sites not in the proximity of residential areas, schools, nursing homes or daycares.

2. Inhalation exposure . For the same reasons non-occupational inhalation exposure to Aspergillus flavus NRRL 21882 is expected to be minimal to non-existent.

Another non-aflatoxin-producing strain of Aspergillus flavus , AF36, is registered, but not for use on corn. Cumulative effects of these strains are not expected to exceed the risk cup for the registered Aspergillus flavus strains, AF36 and NRRL 21882.

Based on the previously evaluated data, it is not necessary to use a safety factor to determine safety to children June 30, 2004, (69 FR 39341).

See Federal Register , June 30, 2004, (69 FR 39341).

See Federal Register , June 30, 2004, (69 FR 39341).

There is no Codex Maximum Residue Level (MRL) for residues of Aspergillus flavus NRRL 21882 on corn.

This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

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

This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

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).

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

• Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

• Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

• Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

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

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr .

Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0203 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before July 16, 2007.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2006-0203, 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.

In the Federal Register of February 7, 2007 (72 FR 5706) (FRL-8111-8, 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 1F6263, 4F4505, 6F4791) by the Acetochlor Registration Partnership (ARP) and Monsanto Company, 1300 “I” St., NW., Washington, DC 20005, and PP 5F6918 by Monsanto Company, 1300 “I” St., NW., Suite 450 East, Washington, DC 20005. The petitions requested that 40 CFR 180.470(a) be amended by establishing tolerances for residues of the herbicide, acetochlor [2-chloro-2-methyl-6-ethyl- N -ethoxymethylacetamide) and its metabolites containing the ethyl methyl aniline (EMA) moiety and the hydroxyethyl methyl-aniline (HEMA) moiety, and expressed as acetochlor equivalents in or on the food commodities corn, field, forage at 3.0 ppm (5F4505) corn, pop, grain at 0.05 part per million (ppm); corn, pop, stover at 1.5 ppm (PP 1F6263); corn, sweet, fodder and forage at 1.5 ppm; and corn, sweet, kernels plus cob with husks removed at 0.05 ppm (6F4791); sorghum, forage at 1.0 ppm; sorghum, grain at 0.05 ppm; and sorghum, grain, stover at 1.5 ppm (5F6918). These petitions also requested that 40 CFR 180.470(d) be amended by establishing tolerances for residues of the herbicide, acetochlor (2-chloro-2-methyl-6-ethyl- N -ethoxymethylacetamide) and its metabolites containing the ethyl methyl aniline (EMA) moiety and the hydroxyethyl methyl-aniline (HEMA) moiety, and expressed as acetochlor equivalents in or on the food commodities beet, sugar, root and tops/ pea and bean (except soybean) dried and shelled (subgroup 6C)/potato/ and grain, cereal (except rice) (group 15),at 0.05 ppm; grain, grain, cereal (except rice), forage/fodder/straw (group 16) forage at 0.5 ppm; grain, cereal (except rice) forage/fodder/straw (group 16) hay at 2.0 ppm; grain, cereal (except rice) forage/fodder/straw (group 16) stover at 0.1 ppm; grain, cereal (except rice) forage/fodder/straw (group 16), straw at 0.3 ppm (1F6263); non-grass animal feeds (group 18) forage at 1.3 ppm; and non-grass animal feeds (group 18) hay at 3.5ppm (6F4791). That notice referenced a summary of the petitions prepared by Acetochlor Registration Partnership and Monsanto Company, the registrants, which have been placed in the public docket, http://www.regulations.gov . There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petitions EPA is reassigning the entries for soybean, forage at 0.7 ppm; soybean, grain at 0.1 ppm; soybean, hay at1.0 ppm; wheat, forage at 0.5 ppm; wheat, grain at 0.02 ppm; and wheat, straw at 0.1 ppm; from 180.470(a) to 180.470(d) and establishing a tolerance for wheat, hay at 2.0 ppm under 40.CFR 180.470(d). The terminology for soybean, grain is being updated to read soybean, seed to conform to Agency procedures. Additionally, EPA is increasing the tolerance for corn, field, forage to 3.0 from 1.0 ppm. This tolerance will be listed in 180.470(a).

Based upon review of the data submitted and Agency procedures concerning commodity names, the Agency is correcting the terminology for pending crops under 40 CFR 180.470(a) as follows: corn, field, forage at 3.0 ppm; corn, pop, grain at 0.05 ppm; corn, pop, stover at 1.5 ppm; corn, sweet, kernels plus cob with husks removed at 0.05 ppm; corn, sweet, forage at 1.5 ppm; and sorghum, grain, grain at 0.05 ppm. The Agency is also correcting the tolerance levels and terminology for pending crops under 40 CFR 180.470(a) as follows: corn, sweet, stover at 1.0 ppm; sorghum, grain, forage at 1.6 ppm; sorghum, grain, grain at 0.05 ppm; and sorghum, grain, stover at 1.7 ppm. The above listings for corn, field, forage; sorghum, grain, forage; sorghum, grain, grain; and sorghum, grain, stover; replace the current listings for corn, field forage; sorghum, forage; sorghum, grain; and sorghum, grain, stover.

The Agency also determined that the tolerance expression and correct terminology for the pending crops under 40 CFR 180.470(d) should be written as follows: Tolerances are also established for indirect or inadvertent residues of acetochlor (2-chloro-2'-methyl-6-ethyl- N -ethoxymethylacetamide) and its metabolites containing the ethyl methyl aniline (EMA) moiety and the hydroxyethyl methyl aniline (HEMA) moiety, to be analyzed as acetochlor and expressed as acetochlor equivalents, in or on the following raw agricultural commodities when present therein as a result of application of acetochlor to growing crops listed in paragraph (a) of this section: Animal feed, nongrass, group 18, forage at 1.3 ppm; animal feed, nongrass, group 18, hay at 3.5 ppm; beet, sugar, root at 0.05 ppm; beet, sugar, tops at 0.05 ppm; grain, cereal, group 15 except for corn, grain sorghum, rice and wheat, grain at 0.05 ppm; grain, cereal, forage, fodder and straw, group 16 except for corn, grain sorghum, rice and wheat, forage at 0.5 ppm; grain, cereal, forage, fodder and straw, group 16,except corn, grain sorghum, rice and wheat, hay at 2.0 ppm; grain, cereal, forage, fodder and straw, Group 16, except corn, grain sorghum, rice and wheat, stover at 0.1 ppm; grain, cereal, forage, fodder and straw, group 16, except corn, grain sorghum, rice and wheat, straw at 0.3 ppm; pea and bean, dried shelled, except soybean, subgroup 6C at 0.05 ppm; potato at 0.05; sunflower, seed at 0.05 ppm and wheat, hay at 2.0 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. . . .” These provisions were added to FFDCA by the Food Quality Protection Act (FQPA) of 1996.

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances and amendments for tolerances for residues of acetochlor (2-chloro-2'-methyl-6-ethyl- N -ethoxymethylacetamide) and its metabolites containing the ethyl methyl aniline (EMA) moiety and the hydroxyethyl methyl aniline (HEMA) moiety, to be analyzed as acetochlor and expressed as acetochlor equivalents.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by acetochlor as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov . The referenced document is entitled “Acetochlor-RED Phase 2 Revised HED Chapter of the TRED” and is available in the docket (EPA-HQ-OPP-2005-0227 identified as document 0004.

For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors (UF) are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. Short-, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (MOE) called for by the product of all applicable uncertainty/safety factors is not exceeded.

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .

A summary of the toxicological endpoints for acetochlor used for human risk assessment can be found at www.regulations.gov in document Acetochlor: Human Health Risk Assessment to Support the Proposed Uses on Sorghum and Sweet Corn and Rotational Crops of Nongrass Animal Feeds (Group 18), Sugar Beets, Dried Shelled Beans and Peas (Subgroup 6C), Sunflowers, Potatoes Cereal Grains (Group 15), and Forage, Fodder and Straw of Cereal Grains (Group 16) on page 11 in Docket ID EPA-HQ-OPP-2006-0203.

1. Dietary exposure from food and feed uses . In evaluating dietary exposure to acetochlor, EPA considered exposure under the petitioned-for tolerances as well as all existing acetochlor tolerances in (40 CFR 180.470). EPA assessed dietary exposures from acetochlor in food as follows:

i. Acute exposure . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. In estimating acute dietary exposure, EPA used food consumption information from the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed all foods for which there are tolerances or for which tolerances are proposed, were treated and contain tolerance-level residues. Experimentally derived processing factors were used for cereal grain commodities. Default values were used for all other processed commodities.

ii. Chronic exposure . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998; Nationwide CSFII. As to residue levels in food, EPA chronic dietary analysis included anticipated residues from field trial data and assumed that all crop were treated. Experimentally derived processing factors were used for cereal grain commodities. Default values were used for all other processed commodities.

iii. Cancer . Previously, EPA has treated acetochlor as a non-threshold carcinogen and conducted a linear low-dose quantitative cancer risk assessment in evaluating its safety. The determination that a quantitative linear low-dose cancer assessment was appropriate was based on findings that acetochlor caused mouse lung tumors and histiocytic sarcomas in female mice. The Agency has reexamined the data and concluded they do not support use of a quantitative linear low-dose cancer assessment. The Agency determined that the relationship of the mouse lung tumors to treatment was equivocal, due to some inconsistencies in dose-response between the two available mouse studies, the relatively frequent occurrence of the tumor in older mice and the lack of evidence of direct genotoxicity of acetochlor. Further the Agency found that the increase in the histiocytic sarcomas in female mice in one study was also equivocal. EPA concludes that this equivocal evidence of cancer shows no greater than a negligible risk of cancer. Nonetheless, acetochlor has been associated with nasal tumors in the rats and these tumors remain as a tumor of concern for human exposure to acetochlor. Because, however, the nasal tumors have been found to be a threshold effect, EPA has not used quantitative linear low-dose cancer assessment in assessing this cancer risk. Rather, EPA has relied on the chronic risk assessment because the chronic Reference Dose (cRfD), which is based on a NOAEL of 2 milligrams/kilograms/day (mg/kg/day), is considered to be protective of nasal tumors for which a point of departure of 10 mg/kg/day was identified. EPA has used the same exposure assumptions in assessing cancer risk as in assessing other chronic risks.

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

2. Dietary exposure from drinking water . The drinking water values used in the dietary risk assessments were based on information provided by the Acetochlor Registration Partner ship water monitoring program to support the current use on field corn. The Agency has determined that the new uses of acetochlor are not likely to result in concentrations exceeding those seen in the field corn monitoring data; therefore this data can be used to estimate drinking water concentrations resulting from the new uses on sweet corn and sorghum. In the monitoring data, exposure to acetochlor parent was significantly higher in the surface water monitoring sites than the ground water monitoring sites; therefore, the concentration used in the acute dietary assessment was from a surface water monitoring site that produced the highest concentration of 0.01821 ppm. The drinking water value used in the chronic dietary risk assessment was from a surface water monitoring site that produced the highest time-weighted annualized mean (TWAM) concentration for a single year of 0.00143 ppm.

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). Acetochlor 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.”

Acetochlor is a member of the chloroacetanilide cumulative assessment group (CAG) which includes alachlor and butachlor. The Agency previously conducted a cumulative risk assessment for the CAG based on a common mode of action for the production of tumors of the nasal olfactory epithelium in rats. Butachlor was determined to be part of the CAG, however, there are currently no U.S. registrations for the chemical; therefore, it was excluded from the cumulative risk assessment. This risk assessment is fully discussed in the document: Cumulative Risks from Chloroacetanilide Pesticides dated March 6, 2006 identified as document EPA-HQ-OPP-2005-0050-0061 which is available on the internet at http://www.regulaions.gov in docket number EPA-HQ-OPP-2005-0050. Based on that cumulative risk assessment (CRA), the Agency concluded that the cumulative risks from alachlor and acetochlor did not exceed the Agency's level of concern since cumulative MOEs were above 13,000 for all populations compared to a cumulative level of concern of 100.

For this risk assessment the Agency believes that the cumulative risk from these new uses in addition to the current existing uses of acetochlor and alachlor will not exceed The Agency's level of concern. Individual risk assessments were conducted based on a point of departure of 10 mg/kg/day for nasal tumors. Anticipated residues based on field trial data and 100% crop treated was assumed for all existing and new uses for acetochlor. The individual acetochlor assessment from food resulted in MOEs raging from 49,000 for children 1-2 years old and children 3-5 years old to 179,000 for adults 50+. The addition of water to the assessment using surrogate data from the corn monitoring studies, resulted in MOEs ranging from 40,000 for children 1-2 years old to 116,000 for adults 50+. The MOEs for the General U.S. population were 111,000 from food and 83,000 from both food and water.

As noted in the March, 2006 cumulative risk assessment for the chloroacetanilide chemicals, alachlor is the index chemical and acetochlor is included in the assessment with a relative potency of 1/20th of alachlor. Further, as noted in the cumulative risk assessment, acetochlor commodities were not considered to be risk drivers in the chloroacetanilide CRA; therefore given the individual MOEs for acetochlor, it is unlikely that the addition of the new uses for acetochlor will cause an unacceptable cumulative risk when considered with the existing alachlor and acetochlor uses.

1. In general . Section 408 of FFDCA provides that EPA shall apply an additional (“10X”) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the 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. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional uncertainty/safety factors and/or special FQPA safety factors, as appropriate.

2. Prenatal and postnatal sensitivity . Concern for prenatal and postnatal susceptibility is low for acetochlor since toxicity to offspring was observed only at maternal toxic doses in developmental toxicity studies in the rat and rabbit and in three multi-generation reproductive toxicity studies in the rat. In addition, clear NOAELS were established in all of these three studies.

3. Conclusion . A 10X FQPA safety factor was applied to the acute dietary risk in the form of a database uncertainty factor to account for the lack of a developmental neurotoxicity study. The following findings support this determination.

i. The toxicity database for acetochlor is not complete at this time. A developmental neurotoxicity study is required based on neurological observations, primarily in the dog or an alternative test which addresses the sensitivity of the dog to neurological effects. In addition, submission of positive control studies for validation of the laboratory methodology used in the acute and subchronic rat oral neurotoxicity screening studies is required as confirmatory data and to upgrade those studies to acceptable.

ii. Evidence of neurotoxicity from exposure to acetochlor was observed in several studies. Salvation and other clinical signs (anogential staining, diarrhea) were reported in some studies in both the rat (two developmental studies) and the dog (subchronic and chronic oral). The dog appears to be more sensitive than the rat or mouse to effects on the nervous system, in that salivation occurred at lower dose levels and frank neuropathology of the brain was observed in one study. In the 1-year oral toxicity study in the dog pronounced neurological signs (ataxia, abnormal head movements, tremor, depressed righting, hoping and flexor reflexes, exaggerated tonic neck reflex and stiffness and rigidity of the hindlimbs) were observed at the high dose and were associated with degenerative lesions of the cerebellum. Other evidence of neurotoxicity is discussed on page 46 of the document entitled “Acetochlor-RED Phase 2 Revised HED Chapter of the TRED” which is available on the internet at http://www.regulaions.gov in the docket identified as EPA-HQ-OPP-2005-0227 document 0004.

iii. The acute dietary endpoint of concern for the general population including females 13-49 years of age, was derived from an acute oral neurotoxicity screening study in rats (NOAEL of 150 mg/kg/day based on decreased motor activity in females. Given the likely dosing in the developmental neurotoxicity study, it is possible that this study could lower the acute RfD by a factor of 10.

EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X for the chronic dietary risk. That decision is based on the following findings.

• The toxicity database for acetochlor is complete other than the lack of a developmental neurotoxicity study.

• Given likely dosing in the developmental neurotoxicity study, it is unlikely that this study would lower the cRFD. The chronic dietary endpoint of concern for all populations was derived from the chronic oral toxicity study in dogs with a NOAEL of 2 mg/kg/day based on the increased salivation and histopathology in testes, kidney and liver at 10 mg/kg/day. The cRFD of 2.0 mg/kg/day is less than the NOAELs in the reproductive study of 21 mg/kg/day. A developmental neurotoxicity study will likely be conducted at dose levels similar to those of the 2-generation rat reproduction study. No evidence of neuropathology or overt neurobehavioral effects were observed in the 2-generation reproductive study with rats.

• There is no evidence that acetochlor 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. The FQPA safety factor was reduces to 1X.

• There are no residual uncertainties identified in the chronic exposure database. The chronic dietary food exposure assessment was based on the assumption of all crops treated and anticipated residues from acceptable field trial data for all commodities. For chronic dietary food exposure assessments, experimentally derived processing factors were used for cereal grain commodities and default processing factors were used for all other processed commodities. The drinking water values used in the dietary risk assessments were based on information provided by the Acetochlor Registration Partnership water monitoring program to support the current use on field corn. These assessments will not underestimate the exposure and risks posed by acetochlor.

Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable 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 acetochlor will occupy <1% of the aPAD at the 95th percentile for the U.S. population and 2.6% of the aPAD at the 95th percentile for all infants, the population subgroup receiving the greatest exposure.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to acetochlor from food and water will utilize <1% of the cPAD for the U.S. population and 1.2 % of the cPAD for children 1-2 years old, the population subgroup receiving the greatest exposure. There are no residential uses for acetochlor that result in chronic residential exposure to acetochlor.

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).

Acetochlor is not registered for use on any sites that would result in residential exposure. Therefore, an aggregate risk assessment for this duration is not appropriate.

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).

Acetochlor is not registered for use on any sites that would result in residential exposure. Therefore, an aggregate risk assessment for this duration is not appropriate.

5. Aggregate cancer risk for U.S. population . As explained above, in Unit III.C.iii., the cRfD is considered to be protective of any cancer risk posed by acetochlor and as discussed in Unit E2, EPA has found that chronic acetochlor exposure does not exceed the cRfD; therefore, aggregate cancer risks are not of concern.

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

An adequate high performance liquid chromatography with oxidative coulometric electrochemical detector (HPLC/OCED) method is available for enforcing new tolerances for acetochlor and its metabolites in sweet corn, sorghum, and rotational crops. This method is listed as Method I for plants in PAM Vol. II.

There are no Codex Maximum Residue Levels established for acetochlor on agricultural commodities.

Therefore, tolerances are established for residues of acetochlor (2-chloro-2'-methyl-6-ethyl- N -ethoxymethylacetamide) and its metabolites containing the ethyl methyl aniline (EMA) moiety and the hydroxyethyl methyl aniline (HEMA) moiety to be analyzed as acetochlor, and expressed as acetochlor equivalents as discussed in Unit II.

This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

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

This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

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).