On January 6, 2005, the NRC announced a realignment of functions of the Office of the Executive Director for Operations. In the realignment, the NRC renamed the Office of the Chief Information Officer as the Office of Information Services. On April 7, 2002, the Commission established the Office of Nuclear Security and Incident Response (NSIR). These amendments include a description of the duties of NSIR. These amendments also reflect the transfer of the allegations program from the Office of Nuclear Reactor Regulation to the Office of Enforcement, the replacement of the reference to the Small Business Regulatory Enforcement Act with the Congressional Review Act, corrections to the addresses for Regions II and III, as well as other minor changes.

Because these amendments constitute minor administrative changes to the regulations concerning agency organization, the notice and comment provisions of the Administrative Procedure Act do not apply under 5 U.S.C. 553(b)(A). The amendments are effective upon publication in the Federal Register . Good cause exists under 5 U.S.C 553(d) to dispense with the usual 30-day delay in the effective date of the final rule, because the amendments are of a minor and administrative nature dealing with changes to certain CFR sections, which do not require action by any person or entity regulated by the NRC. Further, the final rule does not change the substantive responsibilities of any person or entity regulated by the NRC.

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

This final rule does not contain information collection requirements and therefore, is not subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

You may examine the airworthiness directive (AD) docket on the Internet at http://dms.dot.gov or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to certain Boeing Model 737-600, -700, -700C, -800, and -900 series airplanes. That NPRM was published in the Federal Register on July 5, 2005 (70 FR 38636). That NPRM proposed to require modification of certain wire bundles located above the center fuel tank.

We provided the public the opportunity to participate in the development of this AD. We have considered the comments received.

One commenter states that the service bulletin referenced in the NPRM identifies an incorrect type of material for the lacing tape used to tie the subject wire bundles. The commenter reiterates the information in the service bulletin and notes that the material identified therein does not exist. The commenter asks for clarification of the correct type of material for the lacing tape.

We agree with the commenter that clarification is necessary. This AD now identifies the correct type of material for the lacing tape for which an incorrect material was specified in the service bulletin. Lacing tape part number (P/N) BMS 13-54, having Type I, Class 2, Finish C, Grade D, shown in sheet 3 of Figures 5 and 6 of the Accomplishment Instructions of the service bulletin, does not exist; the correct material is BMS 13-54, having Type II, Class 1, Finish D/C, Grade D, white or Type III, Class 1, Finish C, Grade D, white, any size. The manufacturer is aware of this discrepancy, agrees with the change, and has issued Boeing Information Notice (IN) 737-28-1209 IN 01, dated July 28, 2005, to inform operators of the error. We have included this information in paragraph (f) of this AD.

One commenter asks that the work hours specified to accomplish the modification be increased. The commenter states that the referenced service bulletin shows the work hours necessary as 40, but the NPRM specifies only 4 work hours.

We do not agree. The estimate of 40 work hours specified in the service bulletin includes time for gaining access and closing up. The cost analysis in AD rulemaking actions, however, typically does not include costs such as the time required to gain access and close up, time necessary for planning, or time necessitated by other administrative actions. Those incidental costs may vary significantly among operators and are almost impossible to calculate. We recognize that, in doing the actions required by an AD, operators may incur incidental costs in addition to the direct costs. However, the estimate of 4 work hours, as proposed and as specified in this AD, represents the time necessary to perform only the actions actually required by this AD. We have not changed the AD in this regard.

We have changed this AD to clarify the appropriate procedure for notifying the principal inspector before using any approved AMOC on any airplane to which the AMOC applies.

We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are about 1,636 airplanes of the affected design in the worldwide fleet. This AD affects about 650 airplanes of U.S. registry. The modification takes about 4 work hours per airplane, at an average labor rate of $65 per work hour. Required parts cost about $1,446 per airplane. Based on these figures, the estimated cost of the AD for U.S. operators is $1,108,900, or $1,706 per airplane.

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

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

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

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

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

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

(3) 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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

You may examine the airworthiness directive (AD) docket on the Internet at http://dms.dot.gov or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to certain Boeing Model 737 airplanes. That NPRM was published in the Federal Register on November 5, 2004 (69 FR 64515). That NPRM proposed to require, for certain airplanes, a one-time detailed inspection for interference between a clamp assembly and the wires behind the P15 refuel panel, and corrective actions if necessary. For certain other airplanes, that NPRM proposed to require a one-time detailed inspection for discrepancies of the wires behind the P15 refuel panel; and corrective and related investigative actions if necessary.

Since the issuance of the NPRM, the manufacturer has revised the service bulletins referenced in this AD. We have reviewed Boeing Special Attention Service Bulletins 737-28-1193 and 737-28-1200, both Revision 1, both dated July 28, 2005. We have determined that these revised service bulletins will neither increase the economic burden on any operator nor increase the scope of the AD and should be referenced as the appropriate sources of service information for accomplishing the requirements of the AD. Therefore, in the AD, we have revised paragraph (f) to specify the revised service bulletins, inserted new paragraph (g) to give credit for using the original issues of the service bulletins (which were referenced as the appropriate sources of service information for accomplishing the requirements of the AD) to accomplish the required actions before the effective date of the AD, and re-identified existing paragraph (g) to (h).

We provided the public the opportunity to participate in the development of this AD. We have considered the comments that have been submitted on the NPRM.

One commenter requests that paragraph (f)(2)(ii) of the NPRM be changed in the AD to read “For Group 2 airplanes only as defined in Service Bulletin 737-28-1200: Perform a one-time detailed inspection for discrepancies of the wires in wire bundle W0024 to connector D04578P on the back of the P15 refuel panel and do any applicable corrective actions before further flight.” The commenter states this change will provide appropriate operator guidance by tying the detailed inspection of Group 2 airplanes to the applicable service bulletin.

We partially agree. Paragraph (f)(2) of the AD clearly states that all applicable actions listed in paragraphs (f)(2)(i) and (f)(2)(ii) of this AD must be done in accordance with Boeing Special Attention Service Bulletin 737-28-1200, Revision 1, dated July 28, 2005. However, for clarity, as paragraph (f)(2)(i) of the NPRM refers to “Service Bulletin 737-28-1200,” we have revised paragraph (f)(2)(ii) of the AD to also refer to “Service Bulletin 737-28-1200.”

Three commenters request that the AD clarify that inspections accomplished prior to the effective date of the AD using the “visual check” criteria specified in Boeing Special Attention Service Bulletin 737-28-1193, dated April 24, 2003, satisfy the “detailed inspection” requirement of paragraph (f) of the NPRM. One commenter requests that the same clarification be applied for Boeing Special Attention Service Bulletin 737-28-1200, dated July 10, 2003. Another commenter requests that “Note 1” and all references to it be deleted from the AD. The commenters state that Note 1 could be interpreted so that only a detailed inspection as defined in the NPRM that is accomplished prior to the effective date of the AD shall receive credit in accordance with paragraph (e) of the AD. The commenters assert that the inspection criteria identified as a visual check in Boeing Special Attention Service Bulletin 737-28-1193 are equivalent to the detailed inspection criteria described in Note 1 of the NPRM, and therefore, applicable airplanes that have already accomplished the inspection in accordance with Special Attention Service Bulletin 737-28-1193 will not need to be re-inspected.

We partially agree. Airplanes that have received a visual check in accordance with Boeing Special Attention Service Bulletin 737-28-1193, dated April 24, 2003; or Boeing Special Attention Service Bulletin 737-28-1200, dated July 10, 2003; as applicable, prior to the effective date of this AD, may satisfy the requirement of this AD to perform a detailed inspection. If the visual check was performed to the same level of complexity and using equipment comparable to that specified for a detailed inspection as defined in Note 1 of the AD, credit is given according to paragraph (e) of the AD. However, if the visual check did not meet all the parameters defined by Note 1, additional work is necessary to comply with the requirements of the AD. Therefore, we do not agree that the specified visual check necessarily meets the requirements of a detailed inspection; nor do we agree that Note 1 and its applicable references should be deleted from the AD, as Note 1 clarifies what constitutes a detailed inspection. However, if anyone wishes to submit technical data demonstrating that they have performed a visual check that meets the requirements of a detailed inspection as defined in Note 1 of the AD, they may request approval of an alternative method of compliance (AMOC) in accordance with paragraph (h)(1) of the AD. We have not changed the AD in this regard.

Two commenters request that we revise the costs of compliance. One commenter requests that we increase the number of work hours to reflect installation of Teflon sleeves around the wiring and revise the estimated cost accordingly. A second commenter states that it took 6 man-hours per airplane to accomplish the actions specified by the service bulletin, including operational tests. Though the second commenter made no request to change the work hours, we infer that the commenter wishes us to revise the estimated cost to reflect 6 man-hours.

We do not agree with this request. Costs of compliance are limited to only the actions required by the AD, which, in this case, are those actions related to the detailed inspection of the wires in wire bundle W0024 to connector D04578P on the back of the P15 refueling panel required by paragraph (f)(1) of the AD. The cost of any “applicable corrective actions” is conditional on the result of the inspection and, regardless of any AD direction, those actions must be performed to correct an identified unsafe condition to ensure airworthy operation of the airplane, as required by the Federal Aviation Regulations. Further, the number of work-hours listed in the AD is consistent with the number provided by the service bulletin. We have not changed the AD in this regard.

One commenter states that Boeing service bulletins listed in the NPRM have information notices (INs) issued against them that provide minor clarifications and revisions to materials and part numbers. The commenter requests that the final rule allow for the use of the INs with the respective service bulletins when accomplishing the requirements of the AD. The commenter states this would allow operators to take advantage of the changes in the INs without having to request an AMOC.

We concur that the applicable INs may be used with their respective Boeing service bulletins when accomplishing the requirements of the AD. Information Notices 737-28-1193 IN 01 and 737-28-1200 IN 01 were released on September 11, 2003, to provide alternate part numbers, and minor clarifications and revisions to materials and part numbers. The information in these INs was subsequently incorporated into Boeing Special Attention Service Bulletins 737-28-1193 and 737-28-1200, both Revision 1, both dated July 28, 2005. Therefore, we have revised paragraph (g) of the AD to give credit for using the above INs with Boeing Special Attention Service Bulletins 737-28-1193, dated April 24, 2003; or 737-28-1200, dated July 10, 2003; as applicable, for actions accomplished prior to the effective date of this AD.

One commenter requests that the compliance time be reduced. The commenter states that the nature of the fault and hazard that may exist during ground and flight operations justifies reducing the 18 month compliance time specified in paragraph (f) of the NPRM. The commenter did not provide data to substantiate any reduction of the compliance time.

We do not agree to revise the compliance time. The P15 refueling panel is powered only when the refueling panel access door is open for refueling the airplane, so there is no risk imposed during flight operations. Further, the refueling panel is properly grounded to protect the operator from any shock hazard during refueling. Therefore, the unsafe condition does not warrant immediate action and reduced compliance time; however, operators are always free to accomplish the requirements of the AD at any time before the compliance time. We have not changed the AD in this regard.

One commenter requests that the compliance time be increased. The commenter states that Boeing Special Attention Service Bulletin 737-28-1200 recommends a 24-month compliance time and requests that the compliance time be increased to 24 months to align with current Model 737 Next Generation maintenance programs.

We do not agree. We considered the urgency associated with the unsafe condition and the practical aspects of accomplishing the required inspection within an interval that corresponds to the normal maintenance schedules of most affected operators and, with manufacturer concurrence, arrived at an appropriate compliance time of 18 months for all affected airplanes. Further, the manufacturer, in revising Special Attention Service Bulletin 737-28-1200, has reduced the recommended compliance time from 24 months to 18 months, which aligns with the compliance time proposed in the NPRM. In considering all these factors, we determined that this compliance time represents an appropriate interval during which the wiring behind the P15 refueling panel can be inspected and any necessary corrective action taken while still maintaining an adequate level of safety. However, under the provisions of paragraph (h)(1) of the AD, we may approve requests for adjustments to the compliance time if data are submitted to substantiate that such adjustments would provide acceptable levels of safety. In addition, if further technical data are presented that would justify a revised compliance time, we may consider further rulemaking on this issue. We have not changed the AD in this regard.

We have revised this action to clarify the appropriate procedure for notifying the principal inspector before using any approved AMOC on any airplane to which the AMOC applies.

We have carefully reviewed the available data, including the comments that have been submitted, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

This AD affects about 1,653 airplanes of U.S. registry and 4,254 airplanes worldwide. The inspections take about 3 work hours per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of this AD for U.S. operators is $322,335, or $195 per airplane.

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

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

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

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

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

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

(3) 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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD. See the ADDRESSES section for a location to examine the regulatory evaluation.

The Civil Aviation Authority—The Netherlands (CAA-NL), which is the airworthiness authority for the Netherlands, notified us that an unsafe condition may exist on all Fokker Model F27 Mark 050 airplanes. The CAA-NL advises that an operator found heat damage in areas adjacent to the bleed air supply duct assembly while inspecting for hydraulic leakage in the engine controls area on a Model F27 Mark 050 airplane. The same operator also found a second airplane with heat damage after inspecting its remaining fleet. Further investigation revealed that the inner wall of the bleed air supply duct was ruptured, which caused bleed air to escape and blow out the three blanking plugs that are fitted on the outer wall of the bleed air supply duct. As a result, hot bleed air vented into the engine controls area through the holes in the outer wall (created by the blown out blanking plugs) of the bleed air supply duct. This condition, if not corrected, could result in heat damage to control cables, electrical wiring, hydraulic components, and fuel lines, and consequent fire.

Fokker Services B.V. has issued Service Bulletin SBF50-36-006, dated October 1, 2001. The service bulletin describes the procedures for inspecting zones 431 and 441 of the engine controls area to determine if the blanking plugs are installed in place on the outer ducts of the bleed air supply duct assemblies and doing corrective actions if necessary. The corrective actions include the following:

• If the blanking plugs are missing and bleed air loss is evident (i.e., the bleed air supply duct has burned spots, discoloration, or deformation), visually inspecting the components adjacent to the bleed air supply duct assemblies for heat damage (part C of the accomplishment instructions) and replacing the blanking plugs of the bleed air supply duct with clamping devices (part D of the accomplishment instructions).

• If bleed air loss is not evident, replacing the blanking plugs of the bleed air supply duct with clamping devices.

• If there is leakage from the bleed air supply duct due to a ruptured inner duct, replacing the bleed air supply duct assembly with a serviceable bleed air supply duct assembly (i.e, one that has had the blanking plugs replaced with clamping devices).

• If there is a loss of corrosion-preventing compound from the engine control cables, cleaning the cables, inspecting for discoloration, and applying the corrosion-preventing compound.

• If advice is needed for repairing heat damage to a component, wiring, or structures, contacting the manufacturer for additional instructions.

Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. The CAA-NL mandated the service information and issued Dutch airworthiness directive 2001-130, dated October 31, 2001, to ensure the continued airworthiness of these airplanes in the Netherlands.

This airplane models is manufactured in the Netherlands and is type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the CAA-NL has kept the FAA informed of the situation described above. We have examined the CAA-NL's findings, evaluated all pertinent information, and determined that we need to issue an AD for products of this type design that are certificated for operation in the United States.

Therefore, we are issuing this AD to prevent rupture of the bleed air supply duct, which could lead to hot bleed air leaking into the engine controls area and result in heat damage to control cables, electrical wiring, hydraulic components, and fuel lines, and consequent fire. This AD requires accomplishing the actions specified in the service information described previously, except as discussed under “Difference Between the AD and Service Bulletin.”

The service bulletin specifies to contact the manufacturer for instructions on how to repair certain conditions, but this AD would require repairing those conditions using a method that we or the CAA-NL (or its delegated agent) approve. In light of the type of repair that would be required to address the unsafe condition, and consistent with existing bilateral airworthiness agreements, we have determined that, for this AD, a repair we or the CAA-NL approve would be acceptable for compliance with this AD.

The inspection and “visual inspection” specified in the Fokker service bulletin is referred to as a “general visual inspection” in this AD. We have included the definition for a general visual inspection in a note in this AD.

None of the airplanes affected by this action are on the U.S. Register. All airplanes affected by this AD are currently operated by non-U.S. operators under foreign registry; therefore, they are not directly affected by this AD action. However, we consider this AD necessary to ensure that the unsafe condition is addressed if any affected airplane is imported and placed on the U.S. Register in the future.

If an affected airplane is imported and placed on the U.S. Register in the future, the required actions would take about 3 work hours per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of the AD would be $195 per airplane.

No airplane affected by this AD is currently on the U.S. Register. Therefore, providing notice and opportunity for public comment is unnecessary before this AD is issued, and this AD may be made effective in less than 30 days after it is published in the Federal Register .

This AD is a final rule that involves requirements that affect flight safety and was not preceded by notice and an opportunity for public comment; however, we invite you to submit any relevant written data, views, or arguments regarding this AD. Send your comments to an address listed in the ADDRESSES section. Include “Docket No. FAA-2005-22972; Directorate Identifier 2003-NM-265-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the AD that might suggest a need to modify it.

We will post all comments we receive, without change, to http://dms.dot.gov , including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this AD. Using the search function of that Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78), or you may visit http://dms.dot.gov.

You may examine the AD docket on the Internet at http://dms.dot.gov , or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them.

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

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

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

For the reasons discussed above, I certify that the regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

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

3. 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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

You may examine the airworthiness directive (AD) docket on the Internet at http://dms.dot.gov or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to all British Aerospace Model BAC 1-11 200 and 400 series airplanes. That NPRM was published in the Federal Register on September 16, 2005 (70 FR 54671). That NPRM proposed to require revising the airplane flight manual (AFM) to contain applicable AFM amendments, which advise the flightcrew of information pertaining to safely operating the fuel system. The NPRM also proposed to require revising the FAA-approved maintenance program to include certain repetitive maintenance tasks intended to improve the safety of the fuel system.

We have revised this action to clarify the appropriate procedure for notifying the principal inspector before using any approved AMOC on any airplane to which the AMOC applies.

We provided the public the opportunity to participate in the development of this AD. We received no comments on the NPRM or on the determination of the cost to the public.

We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD with the change described previously. We have determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD.

The following table provides the estimated costs for U.S. operators to comply with this AD.

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

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

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

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

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

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

(3) 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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

History

On October 18, 2005, a final rule was published in the Federal Register (70 FR 60424), Airspace Docket No. 05-ASW-1. This rule revised Jet Routes J-8, J-18, J-19, J-58, J-76, J-104 and J-244; and VOR Federal Airways V-60, V-190, V-263 and V-611; Las Vegas, NM. In that rule, the effective date was inadvertently published as December 22, 2005. This action changes the effective date to April 13, 2006.

Accordingly, pursuant to the authority delegated to me, the effective date for Airspace Docket No. 05-ASW-1, as published in the Federal Register on October 18, 2005 (70 FR 60424), Airspace Docket No. 05-ASW-1, is hereby delayed from December 22, 2005 to April 13, 2006.

In this rule, the Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) by creating a new License Exception authorizing the export or reexport of certain items controlled for anti-terrorism (AT) reasons only on the Commerce Control List (CCL) to U.S. persons in Libya. In consultation with U.S. industry, BIS has identified certain items controlled for AT reasons only which are essential for undertaking business or professional activities, including humanitarian activities, in Libya. Excepting these items from license requirements, when consigned to and for use by U.S. persons or their employees only, would facilitate the ability of U.S. persons to do business in Libya without adversely jeopardizing U.S. national security or foreign policy interests with respect to Libya.

This rule is consistent with the President's April 23, 2004, decision to modify United States' sanctions against Libya, in response to Libya's continuing efforts to dismantle its weapons of mass destruction and missile programs and its renunciation of terrorism.

BIS has determined that a change in policy is warranted for certain AT-controlled items that are essential for U.S. persons conducting business or professional activities in Libya. In drafting this rule, BIS considered a range of items controlled for AT reasons only and identified those that could be excepted from license requirements when exported or reexported for the exclusive use of U.S. persons in Libya or their employees (within the scope of their employment). These items are widely available outside the United States, and have a low likelihood to contribute significantly to terrorism or WMD-related activities in Libya. Items classified under Export Control Classification Numbers (ECCNs) 2A994 (portable generators), 5A992 (encryption hardware), 5D992 (“Information Security” “software” not controlled by 5D002) and 9A990 (diesel engines), and certain items classified under ECCNs 3A991 (electronic devices), 3A992 (electronic equipment), 3B992 (test and inspection equipment for electronic components), 4A994 (computers), 5A991 (telecommunications equipment) are eligible for new License Exception United States Persons In Libya (USPL), as set forth in new section 740.19 of the EAR, when those items are exported or reexported to Libya consigned to and for use by U.S. persons and their employees only. The definition of U.S. person set forth in part 772 of the EAR is applicable to this new provision.

Items exported or reexported to Libya pursuant to the new License Exception USPL may only be used by U.S. persons or by non-U.S. person employees within the scope of their employment and must remain under the control and supervision of the U.S. person employer. They may not be transferred to non-U.S. persons in Libya.

Additionally, items exported or reexported to Libya pursuant to License Exception USPL and not consumed or destroyed in the ordinary course of business may be returned to the United States without authorization from BIS, or such items may be reexported to a third country consistent with the provisions of the EAR applicable to such reexports, which in some cases may require authorization from BIS.

Libya remains on the list of state sponsors of terrorism, and, therefore, it is appropriate for the United States to continue to require a license for the export or reexport to non-U.S. persons in Libya of AT-controlled items, as set forth in section 742.20. Further, AT-controlled items not specifically identified as eligible under License Exception USPL continue to require a license if exported or reexported to U.S. persons in Libya.

Although the Export Administration Act of 1979 (EAA), as amended, expired on August 20, 2001, Executive Order 13222 of August 17, 2001 (3 CFR 2001 Comp., p. 783 (2002)) as extended by the Notice of August 2, 2005 (70 FR 45273, August 5, 2005), continues the EAR in effect under the International Emergency Economic Powers Act (IEEPA).

1. This interim rule has been determined to be not significant for the purposes of Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond to nor be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves collections previously approved by the OMB under control numbers 0694-0088, “Multi-Purpose Application,” which carries a burden hour estimate of 58 minutes to prepare and submit form BIS-748. This rule is expected to result in a small decrease in license applications.

3. This rule does not contain policies with federalism implications sufficient to warrant preparation of a federalism assessment under Executive Order 13132.

4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military or foreign affairs function of the United States (see 5 U.S.C. 553(a)(1)). Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. , are not applicable.

However, because of the importance of the issues raised by these regulations, this rule is being issued in interim form and BIS will consider comments in the development of the final regulations. Accordingly, the Department of Commerce (the Department) encourages interested persons who wish to comment to do so at the earliest possible time to permit the fullest consideration of their views.

The period for submission of comments will close December 16, 2005. The Department will consider all comments received before the close of the comment period in developing final regulations. Comments received after the end of the comment period will be considered if possible, but their consideration cannot be assured. The Department will not accept public comments accompanied by a request that a part or all of the material be treated confidentially because of its business proprietary nature or for any other reason. The Department will return such comments and materials to the persons submitting the comments and will not consider them in the development of final regulations. All public comments on these regulations will be a matter of public record and will be available for public inspection and copying. In the interest of accuracy and completeness, the Department requires comments in written form.

Oral comments must be followed by written memoranda, which will also be a matter of public record and will be available for public review and copying. Communications from agencies of the United States Government or foreign governments will not be available for public inspection.

The Office of Administration, Bureau of Industry and Security, U.S. Department of Commerce, displays these public comments on BIS's Freedom of Information Act (FOIA) Web site at http://www.bos.doc.gov/foia . This office does not maintain a separate public inspection facility. If you have technical difficulties accessing this Web site, please call BIS's Office of Administration at (202) 482-0637 for assistance.

In a notice published in the Federal Register of September 9, 2004 (69 FR 54687), FDA announced that a food additive petition (FAP 4A4758) had been filed by Kraft Foods Global, Inc., c/o Hogan and Hartson, 555 13th St. NW., Washington, DC 20004. The petition proposed to amend the food additive regulations in § 172.380 Vitamin D 3 (21 CFR 172.380) to permit the use of vitamin D 3 in cheese and cheese products at a level above that permitted in § 184.1950 Vitamin D (21 CFR 184.1950). Currently, under § 184.1950, milk products, which include cheese and cheese products, may be fortified with vitamin D at a level up to 89 International Units (IU) per (/) 100 grams (g). The petitioner requested that the maximum amount of vitamin D permitted in certain natural and processed cheeses be increased to 81 IU vitamin D 3 /30 g. Cheese and cheese products identified in the petition for increased fortification levels are those with a reference amount customarily consumed (RACC) of 30 g as defined in § 101.12 (21 CFR 101.12), including standardized and nonstandardized natural cheese, processed cheese, cream cheese, and cheese spreads and dips. Hard grating cheeses with smaller reference amounts, such as Parmesan and Romano as defined in §§ 133.165 and 133.183 (21 CFR 133.165 and 133.183), respectively, and those defined by the standards of identity in § 133.148 (21 CFR 133.148), are not included, nor are cheeses with larger reference amounts, such as cottage cheese or ricotta cheese. Cheese-like products made from nondairy starting materials (e.g., soy-based products) are not considered to be cheese and are not included. The new limit would permit vitamin D to be added to cheese and cheese products at a level slightly more than 20 percent of the reference daily intake (RDI) of vitamin D/30 g serving. Under § 101.54 (21 CFR 101.54), food containing 10 to 19 percent of the RDI of a nutrient is allowed to carry a label claim such as “good source” and if the level is 20 percent or more of the RDI, the food label may claim “excellent source.”

Under § 172.380, vitamin D 3 is approved for use as a nutrient supplement in calcium-fortified fruit juices, calcium-fortified fruit juice drinks, meal replacement and other-type bars, and soy-protein based meal replacement beverages represented for special dietary use in reducing or maintaining body weight. Vitamin D  1 , including vitamin D 3 , also is affirmed as generally recognized as safe (GRAS) for use in food under § 184.1950 with the following limitations:

Additionally, under § 184.1950(c)(2) and (c)(3) vitamin D is affirmed as GRAS for use in infant formula and margarine, respectively.

Vitamin D 3 , also known as cholecalciferol, is the chemical 9,10-seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. Humans synthesize vitamin D 3 in skin from its precursor, 7-dehydrocholesterol under exposure to ultraviolet B radiation in sunlight. Other sources of naturally occurring vitamin D are foods such as butter, buttermilk, cheese, cream, eggs, fish, goat milk, meat fats and organ meats, and mushrooms.

Vitamin D is essential for human health. The major function of vitamin D is to maintain blood serum concentrations of calcium and phosphorus by enhancing the absorption of these minerals from the small intestine. Vitamin D deficiency can lead to abnormalities in calcium and bone metabolism such as rickets in children or osteomalacia in adults. At high levels vitamin D may be toxic. Excessive intake of vitamin D elevates blood plasma calcium levels by increased intestinal absorption and/or mobilization from the bone.

To ensure that vitamin D is not added to the U.S. food supply at levels that could raise safety concerns, FDA affirmed vitamin D as GRAS with specific limitations, as listed in § 184.1950. Under 21 CFR 184.1(b)(2), an ingredient affirmed as GRAS with specific limitations may be used in food only within such limitations, including the category of food, functional use, and level of use. Any addition of vitamin D to food beyond those limitations set out in § 184.1950 requires either a food additive regulation or an amendment of § 184.1950.

To support the safety of the proposed uses of vitamin D 3 , Kraft submitted dietary intake estimates from current and proposed uses and from naturally-occurring sources of vitamin D and compared these intake estimates to the tolerable upper intake level (UL) for vitamin D established by the Institute of Medicine (IOM) of the National Academies. Kraft also submitted a number of publications pertaining to human clinical studies on vitamin D. Based on this information, which is discussed in section II of this document, the petitioner concluded that the proposed use of vitamin D 3 in cheese and cheese products is safe.

To establish with reasonable certainty that a food additive is not harmful under its intended conditions of use, FDA considers the projected human dietary intake of the additive, the additive's toxicological data, and other relevant information (such as published literature) available to the agency. FDA compares an individual's estimated daily intake (EDI) of the additive from all sources to an acceptable intake level established by toxicological data. The EDI is determined by projections based on the amount of the additive proposed for use in particular foods and on data regarding the amount consumed from all sources of the additive. The agency commonly uses the EDI for the 90 th percentile consumer of a food additive as a measure of high chronic dietary intake.

The petitioner provided mean and 90 th percentile vitamin D intake estimates for consumers of cheese and cheese products from the following: (1) The proposed food uses; (2) current regulated food uses (including naturally occurring sources of vitamin D); and (3) dietary supplements. 2 Intake estimates for the U.S. population 2 years of age and older were provided, as well as estimates for 18 population subgroups, including breast-fed and nonbreast-fed infants 0 to 11 months of age. The agency agrees with the methodology used to calculate these estimates, with the exception of intake estimates from dietary supplements for infants 0 to 11 months of age.

For consumers 2 years of age and older, Kraft estimated mean and 90 th percentile dietary intakes from current (including naturally occurring sources) and proposed food uses of vitamin D to be 335 IU per person per day (IU/p/d) and 582 IU/p/d, respectively. For breast-fed infants 0 to 11 months of age, mean and 90 th percentile intakes were estimated to be 180 IU/p/d and 322 IU/p/d, respectively. For nonbreast-fed infants 0 to 11 months of age, mean and 90 th percentile intakes were estimated to be 443 IU/p/d and 696 IU/p/d, respectively. For children 1 to 3 years of age, mean and 90 th percentile intake estimates were 383 IU/p/d and 583 IU/p/d, respectively.

The petitioner also considered the intake of vitamin D from dietary supplements. The National Health and Nutrition Examination Survey III (NHANES III) data indicate that approximately 33 percent of the U.S. population 2 years of age and older take dietary supplements. The NHANES III data also show that, when vitamin D is taken as a dietary supplement, the most frequent level is 400 IU/p/d. As a conservative estimate of intake of vitamin D from dietary supplements and conventional food, Kraft considered it appropriate to assume that consumers of cheese and cheese products who take dietary supplements likely would take dietary supplements containing 400 IU of vitamin D. They then added this value to the mean and 90 th percentile intake estimates from current and proposed food uses for consumers 2 years of age and older. For consumers of cheese and cheese products, mean and 90 th percentile dietary intakes from current and proposed food uses and dietary supplements were estimated to be 735 IU/p/d and 982 IU/p/d, respectively, for consumers 2 years of age and older. Kraft chose not to add a value of 400 IU from supplement use to intake estimates for infants 0 to 11 months of age due to the low percentage of infants reported to use supplements (7 percent) in the NHANES III study. While we do not agree with Kraft's choice to exclude supplement use in the vitamin D intake for infants, we believe that, in light of recent recommendations from the American Academy of Pediatrics (AAP), 3 estimating a supplement intake of 200 IU/p/d is more appropriate than 400 IU/p/d for infants.

Based on AAP recommendations, the agency assumed a vitamin D intake of 200 IU from supplement use for infants 0 to 11 months of age, resulting in exposure estimates at the 90th percentile of 522 IU/p/d and 896 IU/p/d for breast-fed and nonbreast-fed infants, respectively. For all other populations (including children and adolescents) we assumed a supplement intake of 400 IU/p/d (Ref. 1).

In 1997, the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board at IOM conducted an extensive review of toxicology and metabolism studies on vitamin D published through 1996. The IOM published a detailed report that included a UL for vitamin D for infants, children, and adults. The IOM UL for vitamin D for children 1 to 18 years of age and adults is 2,000 IU/p/d. The UL for infants less than 1 year of age is 1,000 IU/p/d.

The IOM considers the UL as the highest daily intake level of a nutrient that is unlikely to pose a risk of adverse effects when the nutrient is consumed over long periods of time. The UL is determined using a risk assessment model developed specifically for nutrients and considers intake from all sources: Food, water, nutrient supplements, and pharmacological agents. The dose-response assessment, which concludes with an estimate of the UL, is built upon three toxicological concepts commonly used in assessing the risk of exposures to chemical substances: No-observed-adverse-effect level, lowest-observed-effect level, and an uncertainty factor.

To support the safety of their proposed uses for vitamin D 3 , Kraft submitted scientific articles published subsequent to the IOM report and issuance of the February 2003 final rule for the use of vitamin D 3 in calcium-fortified fruit juices and fruit juice drinks (68 FR 9000, February 27, 2003), including 12 clinical studies in humans in which subjects received both vitamin D and calcium supplementation for periods of up to 3 years. Kraft concluded that the recent publications continue to support the safe use of vitamin D supplementation in both animals and humans. FDA concurs with Kraft's conclusions.

FDA considered the UL established by IOM for infants, children, and adults relative to the intake estimates provided by the petitioner as the primary basis for assessing the safety of the proposed use of vitamin D 3 in cheese and cheese products. For all children and adults 2 years of age and older, mean and 90th percentile intake estimates from current and proposed food uses of vitamin D are well below the IOM UL of 2,000 IU/p/d. For infants 0 to 11 months of age, mean and 90 th percentile intakes are below the UL of 1000 IU/p/d. Additionally, when dietary supplements are included in the calculations, intake estimates remain below the UL. Because the EDI of vitamin D from all sources is less than the UL, the agency concludes that dietary exposure of vitamin D 3 from its proposed use as a nutrient supplement in cheese and cheese products will not pose a safety concern.

Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 13 076 that provides for the use of TYLAN (tylosin tartrate) Soluble in honey bees for the control of American foulbrood ( Paenibacillus larvae ). The approval of this supplemental NADA relied on publicly available safety and effectiveness data contained in Public Master File (PMF) 5783 which were compiled under National Research Support Project 7 (NRSP 7), a national agricultural research program for obtaining clearances for use of new drugs in minor animal species and for special uses. The supplemental NADA is approved as of October 17, 2005, and the regulations in 21 CFR 520.2640 are amended to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has carefully considered the potential environmental impact of this action and has concluded that the action will not have a significant impact on the human environment and that an environmental impact statement is not required. FDA's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

The Old Saybrook-Old Lyme Bridge, at mile 3.4, across the Connecticut River has a vertical clearance in the closed position of 19 feet at mean high water and 22 feet at mean low water. The existing drawbridge operating regulations are listed at 33 CFR 117.205(b).

The owner of the bridge, National Railroad Passenger Corporation (Amtrak), requested a temporary deviation from the drawbridge operating regulations to facilitate scheduled electrical bridge repairs. In order to complete the above repairs the bridge must open on a fixed bridge opening schedule.

This deviation to the operating regulations allows the Old Saybrook-Old Lyme Bridge to operate from November 21, 2005 through December 22, 2005, as follows:

From Monday through Friday, the bridge shall open on signal at 8:15 a.m., 12:15 p.m., and 2:15 p.m., daily. From 4 p.m. through 8 a.m. the bridge shall open on signal after a four-hour advance notice is given by calling the number posted at the bridge.

On Saturday and Sunday, the bridge shall open on signal at 8 a.m., 10 a.m., 1 p.m., and 4 p.m., daily. From 4 p.m. through 8 a.m. the bridge shall open on signal after a four-hour advance notice is given by calling the number posted at the bridge.

The bridge shall open on signal for commercial vessels at any time after a four-hour advance notice is given by calling the number posted at the bridge.

In accordance with 33 CFR 117.35(c), this work will be performed with all due speed in order to return the bridge to normal operation as soon as possible. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The Burlington Northern Railway Company has requested a temporary deviation in order to repair and replace broken bolts on the lift span of the bridge across Berwick Bay, mile 17.5, at Morgan City, St. Mary Parish, Louisiana. This maintenance is essential for the continued safe operation of the railroad bridge. This temporary deviation will allow the bridge to remain in the closed-to-navigation position from 8 a.m. until noon on Tuesday, November 29, 2005 and Wednesday, November 30, 2005.

The vertical lift span bridge has a vertical clearance of 4 feet above National Geodetic Vertical Datum (NGVD) in the closed-to-navigation position and 73 feet above NGVD in the open-to-navigation position. Navigation at the site of the bridge consists of tugs with tows transporting petroleum products, chemicals and construction equipment, commercial fishing vessels, oil industry related work boats and crew boats and some recreational craft. Since the lift span of the bridge will only be closed to navigation four hours per day for two days, ample time will be allowed for commercial and recreational vessels to schedule transits. Accordingly, it has been determined that this closure will not have a significant effect on vessel traffic. The bridge normally remains in the open-to-navigation position until a train enters the signal block, requiring it to close. An average number of openings for the passage of vessels is, therefore, not available. During the repair period, the bridge may open for emergencies; however, delays should be expected to remove all equipment from the bridge. The Intracoastal Waterway—Morgan City to Port Allen Landside Route is an alternate route for vessels with less than a 12-foot draft.

In accordance with 33 CFR 117.35(c), this work will be performed with all due speed in order to return the bridge to normal operation as soon as possible. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Throughout this document the terms “we,” “our,” and “its” refer to the EPA.

On July 15, 2005 (70 FR 40946), EPA published a notice of proposed rulemaking (NPR) for the State of Maryland. The NPR proposed approval of Maryland's attainment plan for the Metropolitan Washington, DC severe 1-hour ozone nonattainment area (the Washington area). Concurrently, EPA proposed to rescind its earlier final rule which disapproved and granted a protective finding for Maryland's 1-hour ozone attainment plan for the Washington area. In that July 15, 2005 notice of proposed rulemaking, EPA also proposed to rescind its earlier rule finding that the State of Maryland failed to submit one required element of a severe 1-hour ozone attainment plan, namely that for a penalty fee program required under sections 182(d)(3) and 185 of the Act.

EPA received comments dated August 15, 2005 opposing our proposed action to approve Maryland's 1-hour ozone attainment plan for the Washington, DC area in the absence of an approved SIP revision for a section 185 penalty fee program covering the Maryland portion of the Washington area.

One comment was that promulgation of the 8-hour ozone standard did not grant EPA the authority to waive the section 185 penalty fee program for the Washington area. In support of this comment, the commenter incorporates the reasons stated in portions of comment letters the commenter had previously submitted on EPA's proposed rules for implementation of the 8-hour ozone NAAQS and on EPA's proposed action on two issues raised in a petition for reconsideration of EPA's rule to implement the 8-hour ozone NAAQS. Specifically, the August 15, 2005 comments enclosed a copy of:

A copy of each of these items has been placed in the docket for this action. The commenter specifically incorporates by reference parts I and III of the June 2, 2003 comments (identified in the August 15, 2005 document as being submitted to EPA on August 3, 2003); and parts 1 and 2 of the March 21, 2005 letter).

The second comment asserts that EPA should defer final action on the Maryland attainment plan for the Washington area until after the resolution of litigation commenced by the commenter over EPA's rules to implement the 8-hour ozone NAAQS which relate to revocation of the 1-hour ozone NAAQS and waiver of the section 185 penalty fee program requirement.

Comment and Response: The commenter incorporated by reference portions of comment letters previously submitted on EPA's proposed rules for implementation of the 8-hour ozone NAAQS (Phase 1 Rule) and EPA's proposed action reconsidering certain aspects of the final Phase 1 8-hour ozone NAAQS implementation rule (Reconsideration Rule). The issues raised in these comments concern EPA's authority and policy bases for determining that States would no longer be required to submit SIP meeting the section 185 fee provision for purposes of the 1-hour ozone NAAQS once that standard no longer applied (i.e., for most areas of the country as of June 15, 2005). EPA responded to these comments in those two rulemaking actions. EPA took final action in the Phase 1 Rule and in the Reconsideration Rule determining that it had authority to determine that the section 185 fee SIP is no longer required in areas where the 1-hour standard had applied. Thus, the comments cited by the commenter are not relevant to this rulemaking where EPA is merely applying that final rule. However, to the extent those comments and responses might have some relevance to the present rulemaking on the Maryland SIP, we incorporate by reference our responses found in the following documents:

Comment: EPA received a comment stating that if EPA did not accept the commenter's arguments for not approving this rule, then EPA should at least defer its final action until the litigation challenging EPA's rules implementing the 8-hour ozone standard is resolved, because EPA's stated basis for rescinding the Maryland SIP disapproval and sanctions clock relies on the national rules. This comment asserts that delay in implementing the section 185 penalty fee requirements would “undermine” air quality in the Washington area and that there is no harm in requiring Maryland to move forward in the interim with adoption of SIP provisions to implement the section 185 penalty fee provisions. The comment notes that the District and Virginia have already adopted and submitted SIP revisions for the section 185 penalty fee program and received EPA's approval of these SIP revisions.

Response: EPA disagrees that we should defer action on the Maryland SIP until the litigation on the Phase 1 and Reconsideration Rules is resolved and that such a deferral would not result in any harm. Such litigation could take a year or more until the court issues a decision. In the interim, the State would face sanctions and a FIP if it failed to adopt and submit the section 185 fees SIP. Thus, harm could result from the imposition of sanctions. Additionally, the State or EPA would also be required to devote resources to developing a section 185 fees SIP or FIP.

Section 185 Penalty Fee and Air Quality: EPA disagrees with the commenter's assertion that approving the Maryland attainment plan without a section 185 penalty fee provision would “undermine the air quality” in the Washington area. The section 185 fee obligation is not a control measure that results in reductions of ozone precursor emissions. As we previously noted, in response to the comments submitted on our rulemaking disapproving Maryland's attainment plan, but granting a protective finding for transportation conformity purposes, the section 185 fee program is not a control measure. See , 70 FR 25719 at 25721-25722, May 13, 2005. Section 185 of the Act simply requires that the SIP contain a provision that major stationary sources within a severe or extreme nonattainment area pay “a fee to the state as a penalty” for failure of that area to attain the ozone NAAQS by the area's attainment date. This penalty fee is based on the tons of volatile organic compounds or nitrogen oxides emitted above a source-specific trigger level during the “attainment year.” It first comes due for emissions during the calendar year beginning after the attainment date and must be paid annually until the area is redesignated to attainment of the ozone NAAQS. 42 U.S.C. 7511d(a)-(c); 7511a(f)(1). Thus, if a severe area, with an attainment date of November 15, 2005, fails to attain by that date, the first penalty assessment will be assessed in calendar year 2006 for emissions that exceed 80% of the source's 2005 baseline emissions.

A penalty fee that is based on emissions could have some incidental effect on emissions if sources decrease their emissions to reduce the amount of the per ton monetary penalty. However, the penalty fee does not ensure that any actual emissions reduction will ever occur, since every source can pay a penalty rather than achieve actual emissions reductions. The provision's plain language evinces an intent to penalize emissions in excess of a threshold by way of a fee; it does not have as a stated purpose the goal of emissions reductions.

In addition, we note that it is unlikely that the section 185 penalty fee would take effect for the Washington, DC severe 1-hour ozone nonattainment. The Act is clear that the section 185 penalty fees apply only if a severe or extreme area fails to attain the ozone NAAQS by the applicable attainment date. If the 1-hour ozone standard were still intact, and if the Washington area were to attain the 1-hour ozone NAAQS by its attainment date of November 15, 2005, then the requirement that sources pay the section 185 penalty fees would never be triggered. A determination that the Washington area has attained or not attained the standard by its attainment date must be based on air quality monitoring data for the 2003 through 2005 (inclusive ozone seasons). The form of the 1-hour ozone standard is such that to show attainment a monitor must have no more than an average of one expected exceedance over a three year period. 40 CFR 50.9. The procedure for determining the number of expected exceedances is set forth in Appendix H to 40. EPA has reviewed the available air quality data for the Washington area. No monitor was violating the 1-hour ozone standard in 2003 and 2004. Additionally, we note our review of the air quality data for the 2005 ozone season (which has not yet been quality-assured by the States and for which the quality-assurance certification is not required until July 1, 2006), indicates there have been no reported exceedances of the 1-hour ozone NAAQS in the Washington area through September 30, 2005. Thus, it seems likely that, had the 1-hour ozone standard not been revoked, the Washington area would attain the 1-hour NAAQS by the area's 1-hour ozone attainment deadline, and that the section 185 fees will not apply for purposes of the 1-hour NAAQS in the area.

EPA's Delay Could Result in Irreparable Harm: We disagree with the commenter that requiring Maryland to adopt the section 185 fees program will not result in irreparable harm.

If we do not find that Maryland has fully met its obligations with respect to the 1-hour attainment demonstration obligation, the Maryland portion of the Washington area will be subject to the 2:1 offset sanction of 40 CFR 52.31 on December 21, 2005 pursuant to our finding that the State failed to submit a section 185 penalty fee program. See 69 FR 29236 (May 21, 2004). The highway sanctions of 40 CFR 52.31 would commence on June 21, 2006. The briefing schedule in the South Coast Air Quality Management Dist v. EPA , No. 04-1200 (and consolidated cases) (D.C. Cir., filed 6-29-04) challenge to the 8-hour implementation rules currently does not call for EPA to submit its brief until January 26, 2006, and final briefs by May 26, 2006, i.e. , after the offset sanctions have commenced and less than a month before the highway sanctions will commence. Therefore, the State would either be subject to sanctions for some period of time, or would need to devote resources to adopting the section 185 fees program. Thus, the State and its citizens would be harmed—either from the sanctions or from the need to devote limited state resources to adopting the program.

EPA is approving Maryland's attainment plan for the Metropolitan Washington, DC severe 1-hour ozone nonattainment area. Concurrently, EPA is determining that Maryland has submitted all required elements of a severe-area 1-hour ozone attainment demonstration and is thus stopping the sanctions and FIP clocks that were started through a finding that the State of Maryland had failed to submit one of the required elements of a severe-area 1-hour attainment plan. See May 13, 2005 (70 FR 25719). Additionally, since the State now has a fully approved 1-hour ozone attainment demonstration SIP, we are lifting the protective finding that was issued with our earlier disapproval of Maryland's 1-hour ozone attainment demonstration. See May 13, 2005 (70 FR 25719).

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal requirement, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

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 January 17, 2006. 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 approving Maryland's attainment plan for the Metropolitan Washington, DC severe 1-hour ozone nonattainment area and rescinding earlier final rules starting sanctions clocks from may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

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

EPA is taking several related actions. EPA is determining that Delaware County has attained the 8-hour ozone NAAQS, and that it has met the requirements for redesignation to attainment of the 8-hour ozone NAAQS under section 107(d)(3)(E) of the CAA. EPA is, therefore, approving a request from the State of Indiana to change the designation of Delaware County from nonattainment to attainment for the 8-hour ozone NAAQS.

EPA is also approving Indiana's ozone maintenance plan for this area as a SIP revision. The maintenance plan is designed to keep Delaware County in attainment of the 8-hour ozone NAAQS for the next 10 years, through 2015. As supported by and consistent with the ozone maintenance plan, EPA is also approving the 2015 VOC and NO X MVEBs for Delaware County for conformity purposes.

These actions pertain to the designation of Delaware County for the 8-hour ozone NAAQS and to the emission controls related to attainment and maintenance of the 8-hour ozone NAAQS in this area. The emissions of concern are VOC and NO X . If you own or operate a VOC or NO X emissions source in Delaware County or live in this area, this final action may impact or apply to you. It may also impact you if you are involved in transportation planning or implementation of emission controls in this area.

EPA has determined that ground-level ozone is detrimental to human health. On July 18, 1997, the EPA promulgated an 8-hour ozone NAAQS (62 FR 38856) of 0.08 parts per million parts of air (0.08 ppm) (80 parts per billion (ppb)). 1 The 8-hour ozone standard replaces a prior 1-hour ozone NAAQS, which was promulgated on February 8, 1979 (44 FR 8202), and which was revoked on June 15, 2005. It should be noted that ground-level ozone is not directly emitted by sources. Rather, emitted NO X and VOC react in the presence of sunlight to form ground-level ozone along with other secondary compounds. NO X and VOC are referred to as “ozone precursors.”

The CAA required EPA to designate as nonattainment any area that violated the 8-hour ozone NAAQS based on the three most recent years of air quality data (2001-2003 ozone data were considered for the initial 8-hour ozone designations). The Federal Register notice making these designations was signed on April 15, 2004, and was published on April 30, 2004 (69 FR 23857).

The CAA contains two sets of provisions—subpart 1 and subpart 2—that address planning and emission control requirements for nonattainment areas. (Both are found in title I, part D of the CAA.) Subpart 1 contains general, less prescriptive, requirements for nonattainment areas for any pollutant, including ozone, governed by a NAAQS, and applies to all nonattainment areas. Subpart 2 contains more specific requirements for certain ozone nonattainment areas, and applies to ozone nonattainment areas classified under section 181 of the CAA. Subpart 1 nonattainment areas, those areas not classified under section 181 of the CAA, are subject only to the provisions of subpart 1. Subpart 2 nonattainment areas, however, are subject to the provisions of subpart 2, as well as to the provisions of subpart 1 (many of the requirements in subpart 1 are superseded by the more-prescriptive requirements of subpart 2).

In the April 30, 2004 designation rulemaking, EPA divided 8-hour ozone nonattainment areas into the categories of subpart 1 nonattainment (basic nonattainment areas) and subpart 2 nonattainment (classified nonattainment areas) based on their 8-hour ozone design values (i.e., the three-year average annual fourth-highest daily maximum 8-hour ozone concentrations at the worst-case monitoring sites in the designated areas) and their 1-hour ozone design values (i.e., the fourth-highest daily maximum 1-hour ozone concentrations over the three-year period at the worst-case monitoring sites in the designated areas). 2 8-hour ozone nonattainment areas with 1-hour ozone design values equaling or exceeding 121 ppb were designated as classified nonattainment areas (as nonattainment areas required to meet the requirements of subpart 2 of the CAA). All other 8-hour ozone nonattainment areas were designated as basic nonattainment areas.

In the April 30, 2004 designation/classification rulemaking, Delaware County was designated as nonattainment for the 8-hour ozone standard, and was identified as a basic, subpart 1 nonattainment area. 3 This designation was based on ozone data collected in Delaware County during the 2001-2003 period.

On August 25, 2005, the State of Indiana requested redesignation of Delaware County to attainment for the 8-hour ozone NAAQS based on ozone data collected during the 2002-2004 period. This redesignation request was supplemented on October 20, 2005 with a clarification of the State's intent with regard to the triggering of contingency measures in the ozone maintenance plan for Delaware County. Today's final rule addresses the ozone redesignation request as modified.

The CAA provides the requirements for redesignating a nonattainment area to attainment. Specifically, section 107(d)(3)(E) allows for redesignation to attainment provided that: (1) The Administrator determines that the area has attained the applicable NAAQS; (2) the Administrator has fully approved an applicable SIP for the area under section 110(k) of the CAA; (3) the Administrator determines that the improvement in air quality is due to permanent and enforceable emissions reductions resulting from implementation of the applicable SIP, Federal air pollution control regulations, and other permanent and enforceable emissions reductions; (4) the Administrator has fully approved a maintenance plan for the area as meeting the requirements of section 175A of the CAA; and, (5) the State containing the area has met all requirements applicable to the area under section 110 and part D of the CAA.

EPA provided guidance on redesignation in the General Preamble for the Implementation of Title I of the CAA Amendments of 1990 on April 16, 1992 (57 FR 13498), and supplemented this guidance on April 29, 1992 (57 FR 13498). EPA provided further guidance on processing redesignation requests in the following documents:

Ozone and Carbon Monoxide Design Value Calculations,” Memorandum from Bill Laxton, June 18, 1990;

“Maintenance Plans for Redesignation of Ozone and Carbon Monoxide Nonattainment Areas,” Memorandum from G.T. Helms, Chief, Ozone/Carbon Monoxide Programs Branch, April 30, 1992;

“Contingency Measures for Ozone and Carbon Monoxide (CO) Redesignations,” Memorandum from G.T. Helms, Chief, Ozone/Carbon Monoxide Programs Branch, June 1, 1992;

“Procedures for Processing Requests to Redesignate Areas to Attainment,” Memorandum from John Calcagni, Director, Air Quality Management Division, September 4, 1992;

“State Implementation Plan (SIP) Actions Submitted in Response to Clean Air Act (Act) Deadlines,” Memorandum from John Calcagni, Director, Air Quality Management Division, October 28, 1992; “Technical Support Documents (TSD's) for Redesignation of Ozone and Carbon Monoxide Nonattainment Areas,” Memorandum from G.T. Helms, Chief, Ozone/Carbon Monoxide Programs Branch, August 17, 1993;

“State Implementation Plan (SIP) Requirements for Areas Submitting Requests for Redesignation to Attainment of the Ozone and Carbon Monoxide (CO) National Ambient Air Quality Standards (NAAQS) On or After November 15, 1992,” Memorandum from Michael H. Shapiro, Acting Assistant Administrator for Air and Radiation, September 17, 1993;

“Use of Actual Emissions in Maintenance Demonstrations for Ozone and CO Nonattainment Areas,” Memorandum from D. Kent Berry, Acting Director, Air Quality Management Division, November 30, 1993;

“Part D New Source Review (part D NSR) Requirements for Areas Requesting Redesignation to Attainment,” Memorandum from Mary D. Nichols, Assistant Administrator for Air and Radiation, October 14, 1994; and,

“Reasonable Further Progress, Attainment Demonstration, and Related Requirements for Ozone Nonattainment Areas Meeting the Ozone National Ambient Air Quality Standard,” Memorandum from John S. Seitz, Director, Office of Air Quality Planning and Standards, May 10, 1995.

Approval of this redesignation request would change the official designation of Delaware County for the 8-hour ozone NAAQS found at 40 CFR part 81 from nonattainment to attainment. This final rule would also incorporate into the Indiana SIP a plan for maintaining the 8-hour ozone NAAQS in the area through 2015. The maintenance plan includes contingency measures to remedy or prevent possible future violations of the 8-hour ozone NAAQS, and establishes MVEB's of 3.50 tons per day (tpd) for VOC and 4.82 tpd for NO X for Delaware County.

In this final rule, EPA: (1) Determines that Delaware County has attained the 8-hour ozone standard and approves the redesignation of Delaware County to attainment of the 8-hour ozone NAAQS; and, (2) approves the ozone maintenance plan and 2015 VOC and NO X MVEBs for this area. The bases for our determination and approvals are as follows:

EPA has determined that Delaware County has attained the 8-hour ozone NAAQS. For ozone, an area may be considered to be attaining the 8-hour ozone NAAQS if there are no violations of the NAAQS, as determined in accordance with 40 CFR 50.10 and Appendix I of 40 CFR part 50, based on the most recent three complete, consecutive calendar years of quality-assured air quality monitoring data at any monitoring site in the area. To attain this standard, the average of the annual fourth-high daily maximum 8-hour average ozone concentrations recorded at each monitor (the monitoring site's ozone design value) over the 3-year period must not exceed the ozone standard. Based on the rounding convention described in 40 CFR part 50, Appendix I, the 8-hour ozone standard is attained if the area's ozone design value (highest ozone design value for all monitoring sites in the area) is 84 ppb or lower. The data must be collected and quality-assured in accordance with 40 CFR part 58, and recorded in EPA's Aerometric Information Retrieval System (AIRS). The ozone monitors generally should have remained at the same locations for the duration of the monitoring period required for demonstrating attainment (for three years or more).

As part of the August 25, 2005 ozone redesignation request, IDEM submitted summarized ozone monitoring data indicating the top four daily maximum 8-hour ozone concentrations for the sole monitoring site in Delaware County, Albany Elementary, for each year during the 2001-2004 period. These ozone concentrations have been quality-assured and are a subset of the quality-assured ozone data stored in EPA's AIRS. The annual fourth-high 8-hour ozone monitoring concentrations and the three-year average fourth-high 8-hour ozone concentrations are summarized in Table 1. Of particular note is the three-year average for the 2002-2004 period, the air quality basis for the determination of attainment for Delaware County.

These data show that the ozone design value (average annual fourth-high daily maximum 8-hour ozone concentration over a three-year period) for the only ozone monitoring site in Delaware County during the 2002-2004 period is below the 85 ppb 8-hour ozone standard violation cut-off. These data support the conclusion that Delaware County did not experience a monitored violation of the 8-hour ozone standard during the period of 2002-2004. Preliminary data through September of the 2005 ozone season show that Delaware County continues to attain the 8-hour ozone standard.

EPA believes that the data submitted by Indiana provide an adequate demonstration that Delaware County has attained the 8-hour ozone NAAQS.

Indiana has committed to continue ozone monitoring in Delaware County. IDEM commits to consult with the EPA prior to making any changes in this ozone monitoring.

We have determined that Indiana has met all currently applicable SIP requirements for purposes of redesignation of Delaware County under section 110 of the CAA (general SIP requirements). We have also determined that the Indiana SIP meets all SIP requirements currently applicable for purposes of redesignation under Part D of title I of the CAA (requirements specific to subpart 1 nonattainment areas). See section 107(d)(3)(E)(v) of the CAA. In addition, we have determined that the Indiana SIP is fully approved with respect to requirements applicable for purposes of redesignation. See section 107(d)(3)(E)(ii) of the CAA. In making these determinations, we have ascertained what SIP requirements are applicable to the area for purposes of redesignation, and have determined that the portions of the SIP meeting these requirements are fully approved under section 110(k) of the CAA. We note that SIPs must be fully approved only with respect to currently applicable requirements of the CAA.

a. Delaware County has met all applicable requirements under section 110 and part D of the CAA. The September 4, 1992 Calcagni memorandum (see “Procedures for Processing Requests to Redesignate Areas to Attainment,” Memorandum from John Calcagni, Director, Air Quality Management Division, September 4, 1992) describes EPA's interpretation of section 107(d)(3)(E) of the CAA. Under this interpretation, to qualify for redesignation of an area to attainment, the state and the area must meet the relevant CAA requirements that come due prior to the state's submittal of a complete redesignation request for the area. See also the September 17, 1993 Shapiro memorandum and 66 FR 12459, 12465-12466 (March 7, 1995) (redesignation of Detroit-Ann Arbor, Michigan to attainment of the 1-hour ozone NAAQS). Applicable requirements of the CAA that come due subsequent to the state's submittal of a complete request remain applicable until a redesignation to attainment is approved, but are not required as a prerequisite to redesignation. See section 175A(c) of the CAA. Sierra Club v. EPA, 375 F.3d 537 (7th Cir. 2004). See also 68 FR 25424, 25427 (May 12, 2003) (redesignation of the St. Louis/East St. Louis area to attainment of the 1-hour ozone NAAQS).

General SIP requirements: Section 110(a) of title I of the CAA contains the general requirements for a SIP, which include: enforceable emission limitations and other emission control measures, means, or techniques; provisions for the establishment and operation of appropriate devices necessary to collect data on ambient air quality; and programs to enforce the emission limitations. General SIP elements and requirements are delineated in section 110(a)(2) of title I, part A of the CAA. These requirements and SIP elements include, but are not limited to, the following: (a) Submittal of a SIP that has been adopted by the state after reasonable public notice and a hearing; (b) provisions for establishment and operation of appropriate procedures needed to monitor ambient air quality; (c) implementation of a source permit program; (d) provisions for implementation of part C requirements (Prevention of Significant Deterioration (PSD)) and part D requirements (New Source Review (NSR)) for new sources or major source modifications; (e) criteria for stationary source emission control measures, monitoring, and reporting; (f) provisions for air quality modeling; and (g) provisions for public and local agency participation.

Section 110(a)(2)(D) of the CAA requires that SIPs contain certain measures to prevent sources in a state from significantly contributing to air quality problems in another state. To implement this provision, EPA has required certain states to establish programs to address transport of air pollutants (NO X SIP call, Clean Air Interstate Rule (CAIR)). However, the section 110(a)(2)(D) requirements for a state are not linked with a particular nonattainment area's designation and classification. EPA believes that the requirements linked with a particular nonattainment area's designation and classification are the relevant measures to evaluate in reviewing a redesignation request. The transport SIP submittal requirements, where applicable, continue to apply to a state regardless of the desgination of any one particular area in the state.

We believe that these requirements should not be construed to be applicable requirements for purposes of redesignation. Further, we believe that the other section 110 elements described above that are not connected with nonattainment plan submissions and not linked with an area's attainment status are also not applicable requirements for purposes of redesignation. A state remains subject to these requirements after an area is redesignated to attainment. We conclude that only the section 110 and part D requirements which are linked with a particular area's designation and classification are the relevant measures in evaluating a redesignation request. This approach is consistent with EPA's existing policy on applicability of conformity and oxygenated fuels requirements for redesignation purposes, as well as with section 184 ozone transport requirements. See Reading, Pennsylvania, proposed and final rulemakings (61 FR 53174-53176, October 10, 1996), (62 FR 24826, May 7, 1997); Cleveland-Akron-Loraine, Ohio, final rulemaking (61 FR 20458, May 7, 1996); and Tampa, Florida, final rulemaking (60 FR 62748, December 7, 1995). See also the discussion on this issue in the Cincinnati ozone redesignation (65 FR 37890, June 19, 2000), and the Pittsburgh ozone redesignation (66 FR 50399, October 19, 2001).

We believe that section 110 elements not linked to the area's nonattainment status are not applicable for purposes of redesignation. Any section 110 requirements that are linked to the part D requirements for 8-hour ozone nonattainment areas are not yet due, since, as explained below, no Part D requirements applicable for purposes of redesignation under the 8-hour standard became due prior to submission of the redesignation requests. Therefore, as discussed above, for purposes of redesignation, they are not considered applicable requirements.

Part D SIP requirements. EPA has determined that the Indiana SIP meets applicable SIP requirements under part D of the CAA since no requirements applicable for purposes of redesignation became due for the 8-hour ozone standard prior to submission of the Delaware County redesignation request. Subpart 1 of part D, found in sections 172-176 of the CAA, sets forth the basic nonattainment area plan requirements applicable to all nonattainment areas. Because Delaware County is a subpart 1 8-hour ozone nonattainment area and is not classified under subpart 2 of part D of the CAA for the 8-hour ozone standard, subpart 2 of part D of the CAA does not apply to this area.

Part D, Subpart 1 applicable requirements. For purposes of evaluating this ozone redesignation request, the applicable part D, subpart 1 SIP requirements for Delaware County are contained in section 172 of the CAA. A thorough discussion of the requirements of section 172 can be found in the General Preamble for Implementation of Title I (57 FR 13498, April 16, 1992).

No requirements applicable for purposes of redesignation under part D became due prior to submission of the redesignation request, and, therefore, none is applicable to the area for purposes of redesignation. For example, the requirement for an ozone attainment demonstration to meet the requirement of section 172(c)(1) is not yet applicable, nor are the requirements for Reasonably Available Control Measures (RACM) and Reasonably Available Control Technology (RACT) (section 172(c)(1)), Reasonable Further Progress (RFP) (section 172(c)(2)), and contingency measures (section 172(c)(9)).

Since the State of Indiana has submitted a complete ozone redesignation request for Delaware County prior to the deadline for any submissions required for purposes of redesignation, we have determined that these requirements do not apply to Delaware County for purposes of redesignation.

Section 176 conformity requirements. Section 176(c) of the CAA requires states to establish criteria and procedures to ensure that the Federally-supported and funded activities, including highway projects, conform to the air planning goals in the applicable SIPs. The requirement to determine conformity applies to transportation plans, programs and projects developed, funded, or approved under Title 23 U.S.C. and the Federal Transit Act (transportation conformity) as well as to all other Federally supported or funded projects (general conformity). State conformity revisions must be consistent with Federal conformity regulations relating to consultation, enforcement, and enforceability that the CAA required the EPA to promulgate.

EPA believes that it is reasonable to interpret the conformity SIP requirements as not applying for purposes of evaluating the ozone redesignation request under section 107(d) of the CAA because state conformity rules are still required after redesignation of an area to attainment of a NAAQS and Federal conformity rules apply where state rules have not been approved. See Wall v. EPA, 265 F.3d 426 (6th Cir. 2001). See also 60 FR 62748 (December 7, 1995) (Tampa, Florida).

Identification and Quantification of Allowable Emissions for Major New or Modified Stationary Sources. EPA has also determined that areas being redesignated need not comply with the requirement that a NSR program be approved prior to redesignation, provided that the area demonstrates maintenance of the standard without part D NSR, since PSD requirements will apply after redesignation. A more detailed rationale for this view is described in a memorandum from Mary Nichols, Assistant Administrator for Air and Radiation, dated October 14, 1994, entitled, “Part D New Source Review Requirements for Areas Requesting Redesignation to Attainment.” Indiana has demonstrated that Delaware County will be able to maintain the 8-hour ozone standard without part D NSR in effect, and therefore, EPA concludes that the State need not have a fully approved part D NSR program prior to approval of the redesignation request. The State's PSD program will become effective in Delaware County upon redesignation to attainment. See rulemakings for Detroit, Michigan (60 FR 12467-12468, March 7, 1995); Cleveland-Akron-Lorain, Ohio (61 FR 20458, 20469-20470, May 7, 1996); Louisville, Kentucky (66 FR 53665, October 23, 2001); Grand Rapids, Michigan (61 FR 31834-31837, June 21, 1996). Thus, the area has satisfied all applicable requirements for purposes of redesignation under section 110 and part D of the CAA.

b. Delaware County has a fully approved SIP under section 110(k) of the CAA. EPA has fully approved the Indiana SIP for Delaware County under section 110(k) of the CAA for all requirements applicable for purposes of redesignation. EPA may rely on prior SIP approvals in approving a redesignation request (See the September 4, 1992 John Calcagni memorandum, page 3, Southwestern Pennsylvania Growth Alliance v. Browner, 144 F.3d 984, 989-990 (6th Cir. 1998), Wall v. EPA, 265 F.3d 426 (6th Cir. 2001)) plus on any additional measures it may approve in conjunction with a redesignation action. See 68 FR 25426 (May 12, 2003). Since the passage of the CAA of 1970, Indiana has adopted and submitted, and EPA has fully approved, provisions addressing the various required SIP elements applicable to Delaware County for the 1-hour ozone standard. No Delaware County-related SIP provisions are currently disapproved, conditionally approved, or partially approved. As indicated above, EPA believes that the section 110 elements not connected with nonattainment plan submissions and not linked to the area's nonattainment status are not applicable requirements for purposes of redesignation. EPA also believes that since the part D requirements applicable for purposes of redesignation did not become due prior to submission of the redesignation request, they also are, therefore, not applicable requirements for purposes of redesignation.

EPA believes that the State of Indiana has demonstrated that the observed air quality improvement in Delaware County is due to permanent and enforceable reductions in emissions resulting from the implementation of the SIP, Federal measures, and other state-adopted measures.

In making this demonstration, the State has documented the changes in VOC and NO X emissions for both Delaware County and for nine Central Indiana Counties (Boone, Hamilton, Hancock, Hendricks, Johnson, Madison, Marion, Morgan, and Shelby), whose emissions are believed to substantially impact the air quality in Delaware County, for the years of 2000 and 2002. 4 2000 is a year in which Delaware was in violation of the 8-hour ozone standard, and 2002 is the first year of the three-year period in which Delaware County attained the 8-hour ozone standard.

A comparison of the VOC and NO X emissions for Delaware County and the Central Indiana Counties for 2000 and 2002 is summarized in Tables 2 and 3.

In the above tables, the most relevant emissions are those for Delaware County. These data show that the local VOC and NO X emissions have declined between 2000, a year preceding the 2001-2003 violation period with emissions indicative of the emissions at the start of the ozone violation period, and 2002, one of the years in the three-year attainment period.

The Central Indiana Counties are generally upwind of Delaware County on high-ozone days. The cumulative VOC and NO X emissions reductions in these Counties have contributed to the observed air quality improvement in Delaware County. Past ozone data analyses and ozone modeling conducted by the States in the Lake Michigan Air Directors Consortium (LADCO) have demonstrated that peak ozone levels throughout the Upper Midwest are significantly impacted by pollutant transport from upwind areas. Therefore, regional emissions reductions are assumed to have contributed to the air quality improvement in Delaware County.

IDEM notes that the NO X emissions in this area (Delaware County and the Central Indiana Counties) are decreasing primarily in response to national emission control programs affecting all Electric Generating Units (EGUs), including the acid rain control program and the NO X SIP call. The VOC reduction in Delaware County is due to a plant closure, which IDEM considers to be permanent and enforceable. The VOC emissions reduction in Marion County is primarily due to mobile source emission controls, including the Federal Motor Vehicle Emissions Control Program, and to implementation of emission controls on stationary sources.

To support the conclusion that the air quality improvement in Delaware County is due to permanent and enforceable emission reductions, IDEM documented the emission controls that have been implemented in Delaware County and in nearby, upwind Counties. The following discusses the emission controls that have been implemented in this area:

a. Reasonably Available Control Technology (RACT). IDEM notes that Delaware County was not previously required to be covered by RACT rules for existing sources under the CAA. Statewide RACT rules, however, have been required by Indiana and implemented through the following RACT rules:

326 IAC 8-1-6 Best Available Control Technology (BACT) for some Sources;

326 IAC 8-2 Surface Coating Emission Limitations;

326 IAC 8-3 Organic Solvent Degreasing Operations;

326 IAC 8-4 Petroleum Sources;

326 IAC 8-5 Miscellaneous Operations;

326 IAC 8-6 Organic Solvent Emission Limitations;

326 IAC 8-8.1 Landfill Emission Controls; and,

326 IAC 8-10 Auto Body Refinishing.

b. NO X Rules. Under EPA's NO X SIP call, Indiana was required to adopt and implement NO X emission control requirements for EGUs, industrial boilers, and cement kilns. Indiana has adopted the required emission control rules. Emission reductions resulting from these rules were required to begin in 2004, and should ultimately reduce NO X emissions by 31 percent statewide, with the emission reductions increasing through 2007. Note that statewide NO X emissions actually began to decline in 2002 as sources phased in emission controls needed to comply with the State's NO X emission control regulations. From 2004 on, NO X emissions from EGUs are capped at a statewide total well below pre-2002 levels. As noted below, NO X emissions are expected to decline further as the State meets the requirements of EPA's Phase II NO X SIP call.

c. Federal Emission Control Measures. Reductions in VOC and NO X emissions have occurred statewide as a result of Federal emission control measures, with additional emission reductions expected to occur in the future as additional emission controls are implemented. The Federal emission control measures have included: (1) National low emission vehicle standards; (2) Tier II emission standards for vehicles; (3) gasoline sulfur limits; and, (4) heavy-duty diesel engine standards. In addition, in 2004, EPA issued the Clean Air Non-road Diesel Rule. This rule will reduce off-road diesel emissions through 2010, with emission reductions starting in 2008.

Based on the information summarized above, we conclude that Indiana has adequately demonstrated that emissions have declined between 2000 and 2002 in Delaware County and in its upwind counties as a result of permanent and enforceable emission controls. Available ozone modeling (see the discussion of available ozone modeling in the section addressing the ozone maintenance plan below) shows that local VOC emission reductions and regional NO X emission reductions lead to lower ozone levels in this area. Based on this observation and the documentation of the emission reductions between 2000 and 2002, we conclude that the VOC and NO X emission reductions that occurred between 2000 and 2002 have contributed to the reduction in peak ozone levels that have been observed in Delaware County between the periods of 2001-2003 and 2002-2004.

In conjunction with the request for the redesignation of Delaware County to attainment of the 8-hour ozone NAAQS, IDEM submitted a requested SIP revision to provide for maintenance of the 8-hour ozone NAAQS in Delaware County for at least 10 years after the redesignation of this area to attainment of the NAAQS, through 2015.

Section 175A of the CAA sets forth the required elements of maintenance plans for areas seeking redesignation from nonattainment to attainment. Under section 175A, a maintenance plan must demonstrate continued attainment of the applicable NAAQS for at least ten years after the Administrator approves the redesignation to attainment. The State must submit a revised maintenance plan eight years after the redesignation which demonstrates that attainment will continue to be maintained for ten years following the initial ten-year maintenance period. To address the possibility of future NAAQS violations, the 8-hour ozone maintenance plan must contain contingency measures, with a schedule for implementation, as EPA deems necessary, to assure prompt correction of any future ozone standard violation.

The September 4, 1992 John Calcagni memorandum provides additional guidance on the content of maintenance plans. An ozone maintenance plan should address the following items: (1) The attainment VOC and NO X emissions inventories; (2) a maintenance demonstration showing maintenance for the ten years of the maintenance period; (3) a commitment to maintain the existing monitoring network; (4) factors and procedures to be used for verification of continued attainment of the NAAQS; and,

(5) a contingency plan to prevent or correct future violations of the NAAQS.

IDEM prepared and documented comprehensive VOC and NO X emissions inventories for Delaware County and the Central Indiana Counties for 2002, the base/attainment year. These emissions include point (significant stationary sources), area (smaller stationary sources and widely-distributed sources), mobile on-road, and mobile non-road sources.

To develop the attainment year emissions inventories, IDEM used the following approaches and sources of data:

Area Sources —Area source VOC and NO X emissions were taken from the Indiana 2002 periodic emissions inventory, which was previously submitted to the EPA. The area source emission estimates were derived using United States Department of Commerce Bureau of Economic Analysis (BEA) growth factors to project emissions to 2002 from prior years.

Mobile On-Road Sources —Mobile on-road emissions were calculated using MOBILE6 emission factors. Traffic data (vehicle miles traveled, vehicle speeds, and vehicle type and age distributions) for 2002 were calculated using the travel demand model and post-processor provided by the Delaware-Muncie Municipal Planning Commission (DMMPC). IDEM has provided detailed data summaries to document the calculation of mobile on-road VOC and NO X emissions for 2002, as well as for the projection years of 2010 and 2015 (further discussed below).

Point Source Emissions —2002 point source emissions were compiled from IDEM's 2002 annual emissions statement database and from the 2002 EPA Air Markets acid rain emissions inventory database.

Mobile Non-Road Emissions —Non-road mobile source emissions were generated by the EPA and documented in the 2002 National Emissions Inventory (NEI). In addition to the data taken from the NEI, IDEM also considered updated and revised emissions obtained from LADCO. IDEM also used data supplied by LADCO contractors to determine and assign emissions by county for railroads, recreational motorboats, and construction equipment. The emissions from construction equipment were revised based on surveys completed in the Midwest.

The 2002 attainment year VOC and NO X emissions for Delaware County are summarized along with the 2010 and 2015 projected emissions for Delaware County in Table 4 below. It is our conclusion that the State has adequately derived and documented the attainment year VOC and NO X emissions for this area.

As part of its August 25, 2005 ozone redesignation request submittal, IDEM requested revision of the SIP to include a 10-year ozone maintenance plan as required by section 175A of the CAA. This submission shows maintenance of the 8-hour ozone NAAQS by demonstrating that current and future emissions of VOC and NO X remain at or below the attainment year emissions levels. 5 Note that a maintenance demonstration may be based on projected emissions and need not be based on ozone modeling. See Wall v. EPA , 265 F.3d 426 (6th Cir. 2001), Sierra Club v. EPA , 375 F.3d 537 (7th Cir. 2004). See also 66 FR 53094, 53099-53100 (October 19, 2001) and 68 FR 25430-25432 (May 12, 2003).

Table 4 summarizes the VOC and NO X emissions for Delaware County for 2002, 2010, and 2015 in Tons Per Summer Day (TPSD). IDEM chose 2010 as an interim year in the 10-year maintenance demonstration period to show that the VOC and NO X emissions are not projected to increase above the 2002 attainment levels in the middle of the 10-year period.

The emission projections show that in Delaware County, emissions are not expected to exceed the levels of the 2002 attainment year inventory during the 10-year maintenance period. Delaware County VOC and NO X emissions are projected to decrease by 5.59 TPSD and 10.48 TPSD, respectively, between 2002 and 2015.

Emission control measures to remain in effect. Indiana commits to maintain the implemented emission control measures after redesignation of Delaware County to attainment of the 8-hour ozone NAAQS. Any revisions to emission control regulations and emission limits will be submitted to the EPA for approval as SIP revisions.

Modeling support for the impact of emission changes on air quality and further improvements in air quality. IDEM notes that, although ozone modeling is not required to support ozone redesignation requests, a significant amount of ozone modeling data exist that support the connection between emission reductions and air quality improvement, including ozone modeling data that support a demonstration of maintenance for Delaware County. IDEM notes that the available ozone modeling data demonstrate that Delaware County is significantly impacted by ozone and ozone precursor transport and that regional NO X emission reductions are significantly beneficial for reducing 8-hour ozone concentrations in Delaware County.

IDEM draws the following conclusions from the various ozone modeling analyses that have addressed the Midwest:

i. EPA Modeling Analyses for the Heavy Duty Engine Rule. EPA conducted ozone modeling for the Tier II vehicles and low-sulfur fuels to support the final rulemaking for the Heavy Duty Engine (HDE) standards and highway diesel fuel rule (Tier II/Low Sulfur Fuel Rule). This modeling, in part, addressed ozone levels in Delaware County and the Central Indiana Counties. A base year of 1996 was modeled, and impacts of fuel changes and the NO X SIP call were modeled using high ozone episodes in 1995. The modeling supports the conclusion that the fuel improvements and the NO X SIP call should result in significant ozone improvements (lower projected ozone concentrations) in Delaware County and in the Central Indiana Counties. Using the modeling results to determine Relative Reduction Factors (RRFs) 6 and considering the 2001-2003 ozone design value (88 ppb) for the Albany Elementary monitoring site, IDEM projected the 2007 ozone design value for the Albany Elementary monitor to be 81.4 ppb. Therefore, the NO X SIP call and fuel modifications considered in the ozone modeling were found to significantly improve the ozone levels in Delaware County.

ii. LADCO Modeling Analysis for the 8-Hour Ozone Standard Assessment. LADCO has performed ozone modeling to evaluate the effects of the NO X SIP call and Tier II/Low Sulfur Fuel Rule on 2007 ozone levels in the Lake Michigan area, which includes Delaware County and the Central Indiana Counties. Like the EPA modeling discussed above, this modeling indicates that the ozone design value for the Albany Elementary monitoring site would be significantly reduced by 2007 as the result of implementing the NO X SIP call and the Tier II/Low Sulfur Fuel Rule.

The modeling results indicate that ozone levels will continue to drop in Delaware County as the modeled emission control programs are implemented. It should be noted that the improved air quality resulting from the existing Federal rules will be supplemented by additional emission reductions resulting from the implementation of the Clean Air Interstate Rule (CAIR) promulgated by the EPA on March 10, 2005, 70 FR 25161. CAIR is expected to further reduce the transport of NO X and ozone into Delaware County as the result of decreased NO X emissions outside of Delaware County.

Indiana currently operates one ozone monitor in Delaware County. IDEM has committed to continue operating and maintaining an approved ozone monitor in Delaware County.

Continued attainment of the ozone NAAQS in Delaware County depends, in part, on the State's tracking of indicators of continued attainment during the maintenance period. The State's plan for verifying continued attainment of the 8-hour standard in Delaware County consists of plans to continue ambient ozone monitoring in accordance with the requirements of 40 CFR part 58. In addition, IDEM will periodically revise and review the VOC and NO X emissions inventories for Delaware County to ensure that emissions growth is not threatening the continued attainment of the 8-hour ozone standard. Emissions inventories will be revised for 2005, 2008, and 2011, as necessary to comply with the emissions inventory reporting requirements of the CAA. The updated emissions inventories will be compared to the 2002 emissions inventories to assess emission trends and assure continued attainment of the 8-hour ozone standard.

The contingency plan provisions are designed to promptly correct or prevent a violation of the NAAQS that might occur after redesignation of an area to attainment. Section 175A of the CAA requires that a maintenance plan include such contingency measures as EPA deems necessary to assure that the State will promptly correct a violation of the NAAQS that might occur after redesignation. The maintenance plan should identify the contingency measures to be adopted, a schedule and procedure for adoption and implementation of the contingency measures, and a time limit for action by the state. The state should also identify specific indicators to be used to determine when the contingency measures need to be adopted and implemented. The maintenance plan must include a requirement that the state will implement all measures with respect to control of the pollutant(s) that were contained in the SIP before redesignation of the area to attainment. See section 175A(d) of the CAA.

As required by section 175A of the CAA, Indiana has adopted a contingency plan for Delaware County to address a possible future ozone air quality problem. The contingency plan adopted by Indiana has two levels of responses, depending on whether a violation of the 8-hour ozone standard is only threatened (Warning Level) or is imminent or has occurred (Action Level).

A Warning Level response will occur when an annual (1-year) fourth-high monitored daily peak 8-hour ozone concentration of 88 ppb or higher is monitored in a single ozone season at any monitor within the ozone maintenance area. A Warning Level response will consist of Indiana performing a study to determine whether the high ozone concentration indicates a trend toward high ozone levels or whether emissions are increasing. If a trend toward higher ozone concentrations exists and is likely to continue, the emissions control measures necessary to reverse the trend will be determined, taking into consideration ease and timing of implementation, as well as economic and social considerations. The study, including applicable recommended next steps, will be completed within 12 months from the close of the ozone season with the recorded high ozone concentration. If emission controls are needed to reverse the adverse ozone trend, the procedures for emission control selection under the Action Level response will be followed.

An Action Level response will occur when a two-year average annual fourth-high monitored daily peak 8-hour ozone concentration of 85 ppb or greater occurs at any monitor in the ozone maintenance area or when a violation of the 8-hour ozone standard occurs at any monitor in the ozone maintenance area (Delaware County). 7 In this situation, IDEM will determine the additional emission control measures needed to assure future attainment of the 8-hour ozone NAAQS. IDEM will focus on emission control measures that can be implemented in a short time, and selected emission control measures will be adopted and implemented within 18 months from the close of the ozone season with ozone monitoring data that prompted the Action Level response. Adoption of any additional emission control measures will be subject to the necessary administrative and legal procedures, including publication of notices and the opportunity for public comment and response. If a new emission control measure is adopted by the State (independent of the ozone contingency needs) or is adopted at a Federal level and is scheduled for implementation in a time frame that will mitigate an ozone air quality problem, IDEM will determine whether this emission control measure is sufficient to address the ozone air quality problem. If IDEM determines that existing or soon-to-be-implemented emissions control measures are adequate to correct the ozone standard violation problem, IDEM may determine that additional emission control measures at the State level may be unnecessary. Regardless, IDEM will submit to the EPA an analysis to demonstrate that proposed emission control measures are adequate to provide for future attainment of the 8-hour ozone NAAQS in a timely manner. EPA notes that it is construing this provision to require that any non-federal control measure relied upon in lieu of a contingency measure will be adopted by the State for inclusion in the State SIP and will be submitted to EPA for approval as a revision of the SIP.

Contingency measures contained in the maintenance plans are those emission controls or other measures that Indiana may choose to adopt and implement to correct possible air quality problems. These include, but are not limited to, the following:

i. Lower Reid vapor pressure gasoline requirements;

ii. Broader geographic applicability of existing emission control measures;

iii. Tightened RACT requirements on existing sources covered by EPA Control Technique Guidelines (CTGs) issued in response to the 1990 CAA amendments;

iv. Application of RACT to smaller existing sources;

v. Vehicle Inspection and Maintenance (I/M);

vi. One or more Transportation Control Measures (TCMs) sufficient to achieve at least a 0.5 percent reduction in actual area-wide VOC emissions, to be selected from the following:

A. Trip reduction programs, including, but not limited to, employer-based transportation management plans, area-wide rideshare programs, work schedule changes, and telecommuting;

B. Transit improvements;

C. Traffic flow improvements; and

D. Other new or innovative transportation measures not yet in widespread use that affect State and local governments as deemed appropriate;

vii. Alternative fuel and diesel retrofit programs for fleet vehicle operations;

viii. Controls on consumer products consistent with those adopted elsewhere in the United States;

ix. VOC or NO X emission offsets for new or modified major sources;

x. VOC or NO X emission offsets for new or modified minor sources;

xi. Increased ratio of the emission offset required for new sources; and,

xii. VOC or NO X emission controls on new minor sources (with VOC or NO X emissions less than 100 tons per year).

As required by section 175A(b) of the CAA, Indiana commits to submit to the EPA an update of the ozone maintenance plan eight years after redesignation of Delaware County to cover an additional 10-year period beyond the initial 10-year maintenance period.

EPA has concluded that the maintenance plan adequately addresses the five basic components of a maintenance plan: attainment inventory, maintenance demonstration, monitoring network, verification of continued attainment, and a contingency plan. The maintenance plan SIP revision submitted by Indiana for Delaware County meets the requirements of section 175A of the CAA, and, therefore is approved.

Under the CAA, states are required to submit, at various times, control strategy SIP revisions and ozone maintenance plans for applicable areas (for ozone nonattainment areas and for areas seeking redesignations to attainment of the ozone standard). These emission control strategy SIP revisions ( e.g. , reasonable further progress SIP and attainment demonstration SIP revisions) and ozone maintenance plans create MVEBs based on on-road mobile source emissions for criteria pollutants and/or their precursors to address pollution from cars and trucks. The MVEBs are the portions of the total allowable emissions that are allocated to highway and transit vehicle use that, together with emissions from other sources in the area, will provide for attainment or maintenance.

Under 40 CFR part 93, a MVEB for an area seeking a redesignation to attainment is established for the last year of the maintenance plan. The MVEB serves as a ceiling on emissions from an area's planned transportation system. The MVEB concept is further explained in the preamble to the November 24, 1993, transportation conformity rule (58 FR 62188). The preamble also describes how to establish the MVEB in the SIP and how to revise the MVEB if needed.

Under section 176(c) of the CAA, new transportation projects, such as the construction of new highways, must “conform” to ( i.e. , be consistent with) the part of the SIP that addresses emissions from cars and trucks. Conformity to the SIP means that transportation activities will not cause new air quality violations, worsen existing air quality violations, or delay timely attainment of the NAAQS. If a transportation plan does not conform, most new transportation projects that would expand the capacity of roadways cannot go forward. Regulations at 40 CFR part 93 set forth EPA policy, criteria, and procedures for demonstrating and assuring conformity of such transportation activities to a SIP.

When reviewing SIP revisions containing MVEBs, including attainment strategies, rate-of-progress plans, and maintenance plans, EPA must affirmatively find that the MVEBs are “adequate” for use in determining transportation conformity. Once EPA affirmatively finds the submitted MVEBs to be adequate for transportation conformity purposes, the MVEBs are used by state and federal agencies in determining whether proposed transportation projects conform to the SIP as required by section 176(c) of the Clean Air Act. EPA's substantive criteria for determining the adequacy of MVEBs are set out in 40 CFR 93.118(e)(4).

EPA's process for determining adequacy of a MVEB consists of three basic steps: (1) Providing public notification of a SIP submission; (2) providing the public the opportunity to comment on the MVEB during a public comment period; and (3) making a finding of adequacy. The process of determining the adequacy of submitted SIP MVEBs was initially outlined in EPA's May 14, 1999 guidance, “Conformity Guidance on Implementation of March 2, 1999, Conformity Court Decision.” This guidance was finalized in the Transportation Conformity Rule Amendments for the “New 8-Hour Ozone and PM2.5 National Ambient Air Quality Standards and Miscellaneous Revisions for Existing Areas; Transportation Conformity Rule Amendments—Response to Court Decision and Additional Rule Change” published on July 1, 2004 (69 FR 40004). EPA follows this guidance and rulemaking in making its adequacy determinations.

Delaware County's 10-year maintenance plan submission contains new VOC and NO X MVEBs for 2015. The availability of the SIP submissions with these 2015 MVEBs was announced for public comment on EPA's adequacy Web page on August 2, 2005, at: http://www.epa.gov/otaq/transp/conform/currsips.htm . The EPA public comment period on adequacy of the 2015 MVEBs for Delaware County closed on September 1, 2005. No requests for this submittal or adverse comments on this submittal were received during the adequacy comment period. On November 7, 2005, EPA informed the State of Indiana, through a letter, that the 2015 MVEBs are adequate for the purposes of transportation conformity analyses.

EPA, through this rulemaking, is approving the MVEBs for use to determine transportation conformity in Delaware County because EPA has determined that the area can maintain attainment of the 8-hour ozone NAAQS for the relevant 10-year period with mobile source emissions at the levels of the MVEBs. IDEM has determined the 2015 MVEBs for Delaware County to be 3.50 tpd for VOC and 4.82 tpd for NO X . It should be noted that these MVEBs exceed the on-road mobile source VOC and NO X emissions projected by IDEM for 2015, as summarized in Table 4 above (“on-road” source sector). IDEM decided to include safety margins (described further below) of 0.17 tpd of VOC and 0.23 tpd for NO X in the MVEBs to provide for mobile source growth. Indiana has demonstrated that Delaware County can maintain the 8-hour ozone NAAQS with mobile source emissions of 3.50 tpd of VOC and 4.82 tpd of NO X in 2015, including the allocated safety margins, since emissions will still remain under attainment year emission levels.

A “safety margin” is the difference between the attainment level of emissions (from all sources) and the projected level of emissions (from all sources) in the maintenance plan. As noted in Table 4, Delaware County VOC and NO X emissions are projected to have safety margins of 5.59 tpd for VOC and 10.48 tpd for NO X in 2015 (the difference between the attainment year, 2002, emissions and the 2015 emissions for all sources in Delaware County). Even if emissions reached the full level of the safety margin, the counties would still demonstrate maintenance since emission levels would equal those in the attainment year.

The MVEBs requested by IDEM contain safety margins for mobile sources significantly smaller than the allowable safety margins reflected in the total emissions for Delaware County. The State is not requesting allocation of the entire available safety margins reflected in the demonstration of maintenance. Therefore, even though the State is requesting MVEBs that exceed the on-road mobile source emissions for 2015 contained in the demonstration of maintenance, the increase in on-road mobile source emissions that can be considered for transportation conformity purposes is well within the safety margins of the ozone maintenance demonstration. Further, once allocated to mobile sources, these safety margins will not be available for use by other sources.

The VOC and NO X MVEBs for Delaware County are approvable because they maintain the total emissions for Delaware County at or below the attainment year inventory levels, as required by the transportation conformity regulations.

EPA is making a determination that Delaware County has attained the 8-hour ozone NAAQS, and EPA is approving the redesignation of Delaware County from nonattainment to attainment for the 8-hour ozone NAAQS. After evaluating Indiana's redesignation request, EPA has determined that it meets the redesignation criteria set forth in section 107(d)(3)(E) of the CAA. The final approval of this redesignation request would change the official designation for Delaware County from nonattainment to attainment for the 8-hour ozone standard.

EPA is also approving the maintenance plan SIP revision for Delaware County. Approval of the maintenance plan is based on Indiana's demonstration that the plan meets the requirements of section 175A of the CAA, as described more fully above. Additionally, EPA is finding adequate and approving the 2015 MVEBs submitted by Indiana in conjunction with the redesignation request.

We are publishing these actions without prior proposal because we view these actions as non-controversial and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the State plan if relevant adverse written comments are filed. This rule will be effective January 3, 2006 without further notice unless we receive relevant adverse written comments by December 16, 2005. If we receive such comments, we will publish a timely withdrawal of the action, informing the public that the rule will not take effect. EPA will respond to the public comments in a subsequent final rule based on the proposed action. The EPA will not institute a second comment period.

Any parties interested in commenting on this action should do so at this time. If we do not receive any comments, this action will be effective January 3, 2006.

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.

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 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (59 FR 22951, November 9, 2000).

This action also does not have federalism implications because it does not have substantial direct effects on the states, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 ( 64 FR 43255 , August 10, 1999). 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 is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the state to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Redesignation is an action that affects the status of a geographical area and 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. section 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 January 17, 2006. 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).)

Throughout this document wherever “we,” or “our” are used we mean EPA. On September 10, 2004 (69 FR 54753), we published a final rulemaking action announcing our approval of the Commonwealth of Virginia hospital/medical/infectious waste incinerator (HMIWI) section 111(d)/129 plan. In that document, we inadvertently included language relating to commercial and industrial solid waste incinerator units in the rule Summary. The intent of the rule Summary was to briefly describe the applicability and scope of the rule. This action corrects the erroneous language.

In rule document 04-20429 published in the Federal Register on September 10, 2004 (69 FR 54753), on page 54753 of the Summary, first column, revise the third sentence to read, “The plan establishes emission limits, monitoring, operating, and recordkeeping requirements for HMIWI units for which construction commenced on or before June 20, 1996.” This revision is consistent with the promulgated Identification of Sources Provision, section 62.11626, of the noted rule and the related emissions guidelines under 40 CFR part 60, subpart Ce.

Section 553 of the Administrative Procedure Act, 5 U.S.C. 553(b)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. We have determined that there is good cause for making today's rule final without prior proposal and opportunity for comment because we are merely correcting an incorrect citation in a previous action. Thus, notice and public procedure are unnecessary. We find that this constitutes good cause under 5 U.S.C. 553(b)(B).

Under Executive Order (E.O.) 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and is therefore not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 Fed. Reg. 28355 (May 22, 2001)). Because the agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the Administrative Procedures Act or any other statute as indicated in the Supplementary Information section above, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C 601 et seq. ), or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of UMRA. This rule also does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it 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 governments, as specified by Executive Order 13132 (64 FR 43255, August 10, 1999). This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

This technical correction action does not involve technical standards; 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. The rule also does not involve special consideration of environmental justice related issues as required by Executive Order 12898 (59 FR 7629, February 16, 1994). In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996). EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1998) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under 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. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, EPA had made such a good cause finding, including the reasons therefore, and established an effective date of November 16, 2005. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This correction to the rule Summary (VA139-5073a) for Virginia is not a “major rule” as defined by 5 U.S.C. 804(2).

Please refer to the final rule that published on August 31, 2005 for general information about potentially affected entities and accessing this document electronically.

EPA published in the Federal Register of August 31, 2005 (70 FR 51628) (FRL-7716-1) regulations establishing tolerances for combined residues of S-metoclachlor in or on certain commodities as set forth in Unit II of the SUPPLEMENTARY INFORMATION of that document. Portions of the regulatory amendments and the regulatory text were set out incorrectly. This document is being published to correct those errors.

Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), provides that, when an Agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a final rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's technical correction final without prior proposal and opportunity for comment, because the use of notice and comment procedures are unnecessary to effectuate this correction. As such, EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B).

No. This action only corrects errors in the amendatory language for a previously published final rule and does not impose any new requirements. EPA's compliance with the statutes and Executive Orders for the underlying rule is discussed in Unit VII. of the August 31, 2005, final rule (70 FR 51628).

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, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a “major rule ” as defined by 5 U.S.C. 804(2).

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

• Crop production (NAICS code 111)

• Animal production (NAICS code 112)

• Food manufacturing (NAICS code 311)

• Pesticide manufacturing (NAICS code 32532)

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

In addition to using EDOCKET (http://www.epa.gov/edocket/ ), you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .

EPA, on its own initiative, in accordance with sections 408(e) and 408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing a tolerance for combined residues of the herbicide sulfosulfuron, [1-(4,6-dimethoxypyrimidin-2yl)-3-[(2-ethanesulfonyl-imidazo[1,2-a]pyridine-3-yl)sulfonyl]urea and metabolites converted to 2-(ethylsulfonyl)-imidazo[1,2-a]pyridine (calculated as sulfosulfuron), in or on Bahiagrass, forage at 11 parts per million (ppm); Bahiagrass, hay at 40 ppm; Bermudagrass, forage at 11 ppm; Bermudagrass, hay at 40 ppm; milk at 0.02 ppm; fat (of cattle, goat, horse and sheep) at 0.04 ppm; meat (of cattle, goat, horse and sheep) at 0.02 ppm; and meat byproducts (cattle, goat, horse and sheep) at 0.50 ppm. These tolerances will expire and are revoked on December 31, 2009. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations.

Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

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. . ..”

Section 18 of the FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act of 1996 (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

Alabama, Georgia, Louisiana, Mississippi and Oklahoma indicate that, with the removal of imazapic from the hay and pasture market, there is no available control for Johnsongrass in Bahiagrass and/or Bermudagrass pasture and hayfields. Growers may experience significant losses without sulfosulfuron to control Johnsongrass. Johnsongrass reduces Bermudagrass hay quality and value. Additionally, under stressful conditions such as drought, frost or trampling, Johnsongrass may produce prussic acid which is toxic to livestock. Imazapic, the herbicide previously used to control Johnsongrass, was removed from the pasture and hay market in January 2004 resulting in the need for an emergency replacement. EPA has authorized under FIFRA section 18 the use of sulfosulfuron on Bahiagrass and Bermudagrass pasture and hayfields for control of Johnsongrass in Alabama, Georgia, Louisiana, Mississippi, and Oklahoma. After having reviewed the submissions, EPA concurs that emergency conditions exist for these States.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of sulfosulfuron in or on forage and hay associated with both Bermudagrass and Bahiagrass, as well as on various animal commodities for which residues may be present. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerances under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemptions in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although these tolerances will expire and are revoked on December 31, 2009, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on forage and hay associated with both Bermudagrass and Bahiagrass, as well as on the various associated animal commodities after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether sulfosulfuron meets EPA's registration requirements for use on Bermudagrass or Bahiagrass or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of sulfosulfuron by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for any State other than Alabama, Georgia, Louisiana, Mississippi, and Oklahoma to use this pesticide on these crops under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for sulfosulfuron, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT .

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 the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

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 sulfosulfuron and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for time-limited tolerances for combined residues of sulfosulfuron and its metabolites (calculated as sulfosulfuron) in or on Bahiagrass, forage at 11 ppm; Bahiagrass, hay at 40 ppm; Bermudagrass, forage at 11 ppm; Bermudagrass, hay at 40 ppm; milk at 0.02 ppm; fat (of cattle, goat, horse and sheep) at 0.04 ppm; meat (of cattle, goat, horse and sheep) at 0.02 ppm; and meat byproducts (cattle, goat, horse and sheep) at 0.50 ppm. EPA's assessment of the dietary exposures and risks associated with establishing these tolerances follows.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological endpoint. However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (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. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF.

For non-dietary risk assessments (other than cancer) the UF is used to determine the level of concern (LOC). For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 -6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for sulfosulfuron used for human risk assessment is shown in the following Table 1:

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.552) for the combined residues of sulfosulfuron, in or on wheat grain, forage, hay, staw and related milk and meat commodities. Risk assessments were conducted by EPA to assess dietary exposures from sulfosulfuron in food as follows:

i. Acute exposure . Acute dietary 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. As summarized in Table 1 (above), EPA's review has concluded that sulfosulfuron has low acute oral, dermal, and inhalation toxicity. It is non-irritating to skin and slightly irritating to eyes. It is not a skin sensitizer. EPA has not selected toxicity endpoints for acute exposure reflecting the low hazard associated with acute exposure to this chemical.

ii. Chronic exposure and cancer assessement . Chronic and cancer dietary risk assessments were conducted using Lifeline TM (ver. 2.00) and the Dietary Exposure Evaluation Model - Food Consumption Intake Database (DEEM-FCID TM , ver. 1.30) models. Both of these models use food consumption data from the USDA's Continuing Surveys of Food Intakes by Individuals (CSFII); 1994-1996 and 1998).

The chronic and cancer analyses assumed tolerance level residues, 100% crop treated, and DEEM TM (ver. 7.76) default processing factors. The Lifeline TM chronic exposure estimates were < 1% cPAD for all population subgroups (therefore less than EPA's level of concern). The Lifeline TM lifetime cancer risk for the U.S. population is 2.0 x 10 -7 (therefore less than EPA's level of concern for the general U.S. population). DEEM-FCID TM resulted in chronic ( < 1% cPAD; children 1-2 years old were the most highly exposed subgroup) and cancer (2.1 x 10 -7 ) exposure estimates similar to Lifeline TM .

In accordance with the Agency's Proposed Guidelines for Carcinogenic Risk Assessment (April 10, 1996), EPA has classified sulfosulfuron as a likely human carcinogen. The weight-of-evidence for this classification includes: (1) Occurrence of rare transitional cell papilloma (benign tumors) and carcinoma of the urinary bladder in female rats; (2) occurrence of rare benign mesenchymal tumors of the urinary bladder in high dose male as well as renal adenomas in female and possibly male mice, and (3) the relevancy of the observed tumors to human exposure.

EPA utilizes a linear low-dose approach (Q1*) for human risk characterization and extrapolation of risk should be based on the incidence of benign mesenchymal tumors in male mice. The rat transitional cell tumors and mouse renal adenomas were not used because of their low incidence. This extrapolation, rather than an MOE approach, is supported by the lack of sufficient data to characterize the mechanism of carcinogenicity. The unit risk, Q1* (in milligrams/kilograms/day) (mg/kg/day) -1 of sulfosulfuron based upon male mouse urinary bladder mesenchymal tumor rates is 1.03 x 10 -3 (mg/kg/day) -1 in human equivalents.

iii. Anticipated residue and percent crop treated (PCT) information . EPA did not use PCT information in this assessment. As stated above, EPA has performed a conservative assessment utilizing an assumption of 100% crop treated, and 100% tolerance levels detected, for the associated commodities.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for sulfosulfuron in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of sulfosulfuron.

The Agency uses the Generic Estimated Environmental Concentration (GENEEC)or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and Screening Concentrations in Groundwater (SCI-GROW), which predicts pesticide concentrations in ground water. In general, EPA will use GENEEC (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model) for a screening-level assessment for surface water. The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead, drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to sulfosulfuron they are further discussed in the aggregate risk sections below.

Based on the GENEEC and SCI-GROW models the EECs of sulfosulfuron for acute exposures are estimated to be 0.66 parts per billion (ppb) for surface water and 1.9 ppb for ground water. The EECs for chronic exposures are estimated to be 1.73 ppb for surface water and 0.295 ppb 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).

There are no residential uses of sulfosulfuron that are expected to result in residential handler exposure. However, the commercial use of sulfosulfuron on residential and recreational turf may lead to post application exposure in individuals. EPA has performed a cancer risk assessment for adults and children based on post application residential exposure.

Cancer risk for residential adults was calculated based on high and low activity. For high-exposure activity, a Transfer Coefficient (Tc) of 1,000 cm 2 /hr (1 hr) was used and for low-exposure activity, a Tc of 500 cm 2 /hr (1 hr) was used.

EPA built several conservative assumptions into the assessment of residential cancer risk. These include using 50 years of exposure and an estimated 20% (default) of dislodgeable foliar residues (DFR) from the turf, which is derived from the maximum application rate. An average of 14 days of DFRs was used for this cancer assessment; this would be considered a 10% decrease each day (from dilution by rain, and mowing of the grass) of the 20% residue for at least 14 days, and then taking the mean value of this 14-day exposure.

The Lifetime Average Daily Dose (LADD) = 6.0 x 10 -5 mg/kg/day for a Tc =1,000 cm 2 /hr (high-exposure activity for 1 hour) and for a Tc = 500 cm 2 /hr (low-exposure activity for 1 hour) is equal to 3.0 x 10 -5 mg/kg/day.

The estimated cancer risk for adults on day zero, based on high-exposure activity for 1 hour (Tc =1,000 cm 2 /hr) is estimated to be 1.2 x 10 -7 . For low-exposure activity (Tc = 500 cm 2 /hr), the risk is estimated to be 6.0 x 10 -8 .

Although it is likely that toddlers would also be exposed to sulfosulfuron from incidental ingestion of grass, soil, or hand-to-mouth transfer, no relevant oral toxicological endpoints have been identified by EPA. Therefore, to address the short-term residential risk to children from incidental exposure, for the purposes of this assessment only, EPA used the NOAEL of 24 mg/kg/day from the combined chronic toxicity/carcinogenicity study in rats. This NOAEL is considered conservative and health protective for this assessment because it represents the lowest NOAEL in the most sensitive species (the basis for the cRfD).

Postapplication inhalation exposure is considered to be negligible. However, non-dietary, incidental ingestion of residues from treated turfgrass and ingestion of contaminated soil are possible.

As a conservative measure, the exposure and risk estimates for four residential exposure scenarios are assessed for the day of application (day zero) because it is assumed that toddlers could contact the lawn immediately after application. Chronic exposure is not expected (i.e., these activities are not expected to occur continuously for more than 30 days).

Children's estimated risk from oral hand-to-mouth activities on treated lawns is estimated to result in a short-term MOE of 1,700. Children's estimated risk from oral object-to-mouth (turfgrass) from treated lawns is estimated to result in a short-term MOE of 6,800. Children's estimated risk from incidental ingestion of soil from treated lawns is estimated to result in a short-term MOE of 510,000. Since short-term MOEs are above 100, they do not exceed EPA's level of concern. Chronic or long-term exposure is not expected.

While considered unlikely, if a toddler were to experience exposure from all of these sources at the same time, the combined incidental oral exposure would be 0.018 mg/kg/day. This combined exposure results in an estimated MOE of 1,400, which does not exceed EPA's level 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 sulfosulfuron and any other substances and sulfosulfuron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that sulfosulfuron 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 MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Developmental reproductive toxicity studies . The results of the 2-generation reproduction and developmental toxicity studies indicated that sulfosulfuron is not a developmental or reproductive toxicant. The acute and subchronic neurotoxicity studies showed that sulfosulfuron is not neurotoxic. Sulfosulfuron is rapidly excreted, primarily unmetabolized. Excretion at low dose occurred primarily in the urine, whereas at high dose, a large percentage of the administered dose was excreted in the feces. Sulfosulfuron was not retained in tissues to any significant extent.

3. Conclusion . There is a complete toxicity data base for sulfosulfuron and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA has determined that the 10X safety factor to protect infants and children should be removed. The FQPA factor is removed because the developmental and reproductive toxicity data did not indicate increased susceptibility of rats or rabbits to in utero and/or postnatal exposure. Any detectable residues in food or drinking water would be expected at low levels since application rates are low. There are currently no registered homeowner uses for sulfosulfuron. Finally, concern for post-application exposure to infants and children from commercial application of the pesticide is tempered by the low acute oral, dermal, and inhalation toxicity of this pesticide.

To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water (e.g., allowable chronic water exposure (mg/kg/day)) = cPAD - (average food + chronic non-dietary, non-occupational exposure). This allowable exposure through drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by EPA's Office of Water are used to calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short-term, intermediate-term, chronic, and cancer.

When EECs for surface water and ground water are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to sulfosulfuron in drinking water (when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of sulfosulfuron on drinking water as a part of the aggregate risk assessment process.

1. Acute risk . As discussed earlier, sulfosulfuron has low acute oral, dermal, and inhalation toxicity. It is non-irritating to skin, slightly irritating to eyes and is not a skin sensitizer. Endpoints for risk assessment through exposure via the acute dietary, dermal, inhalation and incidental oral routes were not identified; therefore, acute, short- and intermediate-term dermal and inhalation risk were not concerns.

2. Chronic risk . Chronic and cancer aggregate risk assessments were performed for adults, while short-term and chronic aggregate risk assessments were performed for children. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to sulfosulfuron from food will utilize < 1% of the cPAD for all population subgroups, including infants and children, young children, young adults, females of childbearing age and for the overall U.S. population. Based the use pattern, chronic residential exposure to residues of sulfosulfuron is not expected. In addition, despite the potential for chronic dietary exposure to sulfosulfuron in drinking water, after calculating DWLOCs and comparing them to conservative model EECs of sulfosulfuron in surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 2:

3. Short-term risk . The short-term aggregate risk takes into account the exposure from potential residential sources in addition to average dietary residues from food and drinking water. The short-term aggregate risk assessment was performed for children only, since an endpoint for dermal risk assessment was not identified. The resulting short-term DWLOC is 2,200 ppb and is not of concern because it exceeds the EECs for sulfosulfuron. Short-term aggregate risks are presented in the following Table 3:

4. Intermediate-term risk . Intermediate-term aggregate exposure takes into account non-dietary, non-occupational exposure plus chronic exposure to food and water (considered to be a background exposure level). Although residential exposure could occur with the use of sulfosulfuron, no toxicological effects have been identified for intermediate-term toxicity. Therefore, the aggregate risk is the sum of the risk from food and water, which were previously addressed.

5. Aggregate cancer risk for U.S. population . The cancer aggregate risk assessment considered exposure from food, water and residential sources. EPA performs cancer assessments for only the general U.S. population. The cancer dietary analyses assumed tolerance level residues, 100% crop treated, and DEEM default processing factors. The Lifeline TM lifetime cancer risk for the U.S. population is 2.0 x 10 -7 and is therefore less than EPA's level of concern. Residential cancer risk was estimated for adults only. The aggregate cancer risk DWLOC of 25 ppb exceeds EECs for sulfosulfuron and does not result in a 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, and to infants and children from aggregate exposure to sulfosulfuron residues.

Adequate enforcement methodology (example—gas chromatography) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

In accordance with the Act and the Reorganization Plan No. 4 of 1970, NMFS has jurisdiction over these taxa. Under section 4(a)(2) of the Act, NMFS must decide whether a species under its jurisdiction should be classified as endangered or threatened. The Service is responsible for the actual amendment of the List in 50 CFR 17.11(h).

On May 5, 2000, NMFS published a proposed rule (65 FR 26167) to list the white abalone as endangered. During the public comment period for that proposed rule, NMFS received nine written comments. On May 29, 2001, NMFS published a final rule to list the white abalone as endangered (66 FR 29046). The listing was effective as of June 28, 2001. In that final rule, NMFS addressed all public comments received in response to the proposed rule.

On April 16, 2001, NMFS published a proposed rule to list the smalltooth sawfish as endangered on (66 FR 19414). During the 60-day public comment period, NMFS received 12 written comments on the proposed rule. On April 1, 2003, NMFS published a final rule to list the DPS of smalltooth sawfish in the United States as an endangered species (68 FR 15674). The listing was effective as of May 1, 2003. In that final rule, NMFS addressed all comments received in response to the proposed rule.

Because NMFS provided a public comment period on the proposed rules for these two taxa, and because this action of the Service to amend the List in accordance with the determination by NMFS is nondiscretionary, the Service has omitted the notice and public comment procedures of 5 U.S.C. 553(b) for this action.

For more information concerning these two listing determinations, please consult the respective rules published in the Federal Register .

The Service has determined that an Environmental Assessment, as defined under the authority of the National Environmental Policy Act of 1969, need not be prepared in connection with regulations adopted pursuant to section 4(a) of the Act. A notice outlining the Service's reasons for this determination was published in the Federal Register on October 25, 1983 (48 FR 49244).

The Service has examined this regulation under the Paperwork Reduction Act of 1995 and found it to contain no information collection requirements. We may not conduct or sponsor, and you are not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number.