On April 19, 2002, the Office of Personnel Management (OPM) published interim regulations (67 FR 19319) to implement the new premium pay limitations established by section 1114 of the National Defense Authorization Act for Fiscal Year 2002 (Pub. L. 107-107, December 28, 2001). Section 1114 amended 5 U.S.C. 5547, which establishes biweekly or annual limitations on the premium pay that a covered Federal employee may receive.

By law, the section 1114 amendments became effective on the first day of the first pay period beginning on or after the 120th day following enactment. The 120th day fell on Saturday, April 27, 2002. Since most biweekly pay periods for Federal employees begin on a Sunday, these provisions began to apply on either April 28 or May 5, 2002, depending on the employing agency's payroll cycle.

The 60-day comment period ended on June 18, 2002. We received comments from three Federal agencies.

One agency expressed concern that the exact method of applying the annual premium pay cap is not clearly described in the current regulations and that certain interpretations could result in significant administrative burdens. The agency observed that an employee may be employed in multiple locality pay areas over the course of a year. Thus, if the annual cap is based on the last applicable locality pay area in a calendar year, an agency might have to correct payments made in past pay periods. The agency pointed out that the administrative burden would be even greater in cases where an employee transfers to a different agency and payroll provider. The agency recommended that OPM address these issues in regulations. It specifically requested that, in cases where an employee moves from one agency or activity to another, OPM not require the losing agency or activity to recompute the employee's premium pay entitlements based on changes in the applicable GS-15 maximum rate after the employee's departure.

While we understand the agency's concerns about administrative burdens, the law expressly provides that the annual premium pay cap must be applied to an entire calendar year and that it is based on the applicable rates in effect at the end of the calendar year. A geographic move to an area with different pay rates can raise or lower an employee's aggregate basic pay and the end-of-year annual cap on premium pay. In turn, a change in aggregate basic pay or the end-of-year cap can change retroactively the date on which an employee reached the annual premium pay cap. In some cases, an agency may have to recompute retroactively the amount of premium pay owed for one or more pay periods.

In certain cases where an employee transfers to a different agency, the former agency may need to provide the new agency with information on basic pay and premium pay received by the employee in the current calendar year through the date of transfer. In some cases, the new agency may need to provide information to the former agency regarding an employee's aggregate basic pay and end-of-year cap. Each agency is responsible for proper application of the annual cap for the pay periods during which it employed the employee. Agencies cannot avoid certain administrative burdens based on the express statutory language in 5 U.S.C. 5547(b)(2), and we cannot change the regulations without a legislative amendment to reduce or eliminate these administrative burdens.

We note that § 550.106(e) provides that an agency may defer—until the end of the calendar year—payment of additional premium pay owed an employee who is subject to an annual cap. Thus, while some of the administrative burdens associated with applying the annual cap remain, an agency may be able to avoid the burden of collecting an overpayment in some cases.

Under § 550.106(b)(1), the head of an agency or designee is authorized to make determinations concerning mission-critical work in order to apply the annual cap provisions of § 550.107(c) instead of the biweekly cap provisions in § 550.105(a). An agency commented that some readers have interpreted § 550.106(b)(1) to mean that a new written delegation of authority is required to cover a mission-critical work determination. The commenter recommended clarification that this phrase was not intended to require an agency head to generate new written delegations of authority.

It is not our intent to mandate or require a new written delegation of authority to cover mission-critical work determinations. If an agency head has provided a broad delegation of authority that covers a variety of actions and that delegation can be interpreted to encompass the action of making a mission-critical work determination, a new delegation is not required.

Another agency was concerned that § 550.106(a) and (b) might be interpreted to require agencies to make emergency and mission-critical work determinations for each pay period, which would be administratively burdensome. The agency suggested that OPM clarify that these determinations could be made for a situation or event.

The regulations do not require that separate emergency and mission-critical determinations be made for each pay period. The reference to “any pay period” at the beginning of § 550.106(a) and (b) simply means that premium pay is subject to an annual cap instead of the biweekly cap for all pay periods during which the emergency or mission-critical work determination is in effect. Each agency should maintain appropriate documentation to show which pay periods are covered by a determination for each affected employee. The agency must either (1) at the outset, prospectively set a specified period of time during which the determination will be in effect, or (2) leave the ending date open-ended at the outset and then, at the appropriate time, take formal action to terminate the determination as of a specific date.

We have received questions regarding what happens when the emergency or mission-critical work determination is terminated before the end of the calendar year. As provided in 5 U.S.C. 5547(b) and § 550.106(c), the annual cap applies to the entire calendar year. Even if an employee is again placed under a biweekly cap before the end of the calendar year (because the emergency or mission-critical work conditions are no longer in effect), the employee would still remain subject to the annual cap for the duration of the calendar year. Thus, we are adding a new paragraph (g) to § 550.106 to state more clearly that an employee remains subject to the annual cap through the remainder of the calendar year and thus could be covered simultaneously by both the biweekly cap and the annual cap.

One agency commenter was concerned that § 550.106(e) might be interpreted as requiring an agency to defer until the end of the calendar year payment of all additional premium pay resulting from application of an annual cap. The commenter recommended revising the regulations to read, “an agency may defer payment of some or all of the additional premium pay.” The intent of the regulation was to provide agencies with broad authority to defer whatever amount of additional premium pay they determined to be appropriate. (In fact, an agency may even decide to release deferred monies to the employee well before the end of the calendar year if it determines this to be appropriate.) Accordingly, we are revising § 550.106(e) as recommended by the commenter.

An agency commenter stated that the calculations used to determine the biweekly cap are not clearly stated in §§ 550.105 and 550.107. The commenter suggested clarifying the calculations to be used in determining the biweekly cap. We calculate the biweekly premium pay cap for each locality pay area and publish this calculation in our annual publication of the Salary Table Book. We also post the biweekly premium pay cap for each locality pay area on our Web site. The premium pay caps can be accessed on our Web site at http://www.opm.gov/oca/pay/HTML/factindx.asp . In response to this comment, we are adding a new paragraph (d) to § 550.105 that explains how biweekly rates are computed, consistent with the requirements of 5 U.S.C. 5504. Also, we are adding a paragraph in § 550.107 that refers to § 550.105(d).

An agency commenter recommended replacing the term “paycheck” in § 550.106(d)(3) with the term “salary payment,” since most employees are paid by direct deposit. We adopted this suggestion.

An agency commenter suggested including a statement in the regulations that “pursuant to section 118 of the Omnibus Consolidated and Emergency Supplemental Appropriations for Fiscal Year 2001, the biweekly cap does not apply to premium pay for protective services authorized under 18 U.S.C. 3056(a).” (Section 118 provides for use of a special annual cap. This provision applies mainly to Secret Service agents.) We agree that the regular biweekly and annual premium pay caps do not apply to employees performing such protective services. Thus, we are adding a new paragraph (e) to § 550.105 to acknowledge that, notwithstanding the provisions in § 550.105, premium pay for protective services authorized by 18 U.S.C. 3056(a) is subject to the requirements in section 118 of the Treasury and General Government Appropriations Act of 2001 (as enacted into law by section 1(3) of Pub. L. 106-554).

An agency questioned why the special rules in § 550.107 (dealing with use of a biweekly cap for certain types of premium payments for employees otherwise under an annual cap) apply to non-law enforcement officers who are receiving annual premium pay for administratively uncontrollable overtime (AUO) work. The agency noted that AUO pay is retirement-creditable for law enforcement officers only and that one of the rationales given for continued use of a biweekly cap was the retirement creditability of the types of payments listed in § 550.107. The interim regulations offered another rationale for the special treatment of AUO pay and other listed premium payments. These payments are intended to be stable salary supplements that employees can count on from pay period to pay period. Placing AUO pay under the annual cap provisions could result in loss of this salary supplement during the latter part of the calendar year. This rationale applies equally to non-law enforcement officers. Therefore, we believe it is appropriate that AUO pay be included under the special rules in § 550.107 regardless of the type of employee receiving it.

I certify that these regulations will not have a significant economic impact on a substantial number of small entities because they will affect only Federal agencies and employees.

The Office of Management and Budget has reviewed this rule in accordance with Executive Order 12866.

What is the background of the subject matter? Cessna designed add-on shoulder harness assembly accessory kits for the pilot/co-pilot seats for certain Cessna airplanes. These shoulder harness assemblies incorporate a retainer spring in the adjuster on the upper and lower shoulder harness. The retainer spring may have been inadvertently installed on the belt friction pin. This installation of the spring in the upper shoulder harness adjuster will not allow the belt webbing to lock in place.

This caused us to issue AD 86-26-04, Amendment 39-5503 (52 FR 520, January 7, 1987). AD 86-26-04 currently requires the following on certain Cessna 120, 140, 140A, 150, F150, 170, 172, F172, FR172, P172D, 175, 177, 180, 182, 185, A185E, 190, 195, 205, 205A, 206, P206, P206E, TP206A, TU206, TU206E, U206, U206E, 207, T207, 210, T210, 336, 337, and T337 series airplanes:

What has happened since AD 86-26-04 to initiate this action? We have received reports that additional airplanes have the same unsafe condition. Cessna has revised the related service information to include these additional airplanes.

Cessna also revised the service information to correct the reference to the part number (P/N) of the shoulder harness adjusters. The P/N is referenced as 44030-401 in Cessna Single Engine Service Bulletin SEB86-8 and Cessna Multi-engine Service Bulletin MEB86-22, both dated November 21, 1986. The correct P/N is 443030-401.

What is the potential impact if FAA took no action? If not corrected, the shoulder harness could fail to maintain proper belt length adjustment and tension. Such failure could result in pilot/co-pilot injury.

Has FAA taken any action to this point? We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to certain Cessna Models 120, 140, 140A, 150, F150, 170, 172, F172, FR172, P172D, 175, 177, 180, 182, 185, A185E, 190, 195, 206, P206, U206, TP206, TU206, 207, T207, 210, T210, 336, 337, and T337 series airplanes. This proposal was published in the Federal Register as a supplemental notice of proposed rulemaking (NPRM) on February 27, 2004 (69 FR 9277). The supplemental NPRM proposed to supersede AD 86-26-04 with a new AD that would require you to:

Was the public invited to comment? The FAA encouraged interested persons to participate in the making of this amendment. The following presents the comment received on the proposal and FAA's response to the comment:

What is the commenter's concern? The commenter states that there is confusion about whether retainer springs, P/N 443030-401, used in Cessna service kits are affected by this AD. The commenter states that the service kits are different and unrelated to the shoulder harness assembly accessory kits referenced in the AD. The commenter believes this is confusing and may result in a mechanic cutting the spring on the service kit adjusters in an effort to comply with this AD.

The commenter wants us to put a note in the AD to clarify that Cessna service kits that incorporate the use of P/N 443030-401 are not affected by this AD.

What is FAA's response to the concern? We concur with the commenter and will add a paragraph in the AD for clarification. We will change the final rule AD action based on this comment.

What is FAA's final determination on this issue? We carefully reviewed all available information related to the subject presented above and determined that air safety and the public interest require the adoption of the rule as proposed except for the changes discussed above and minor editorial corrections. We have determined that these changes and minor corrections:

How does the revision to 14 CFR part 39 affect this AD? On July 10, 2002, the FAA published a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's AD system. This regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance. This material previously was included in each individual AD. Since this material is included in 14 CFR part 39, we will not include it in future AD actions.

How many airplanes does this AD impact? We estimate that this AD affects 75,329 airplanes in the U.S. registry.

What is the cost impact of this AD on owners/operators of the affected airplanes? We estimate the following costs to accomplish the inspection:

We estimate the following costs to accomplish any necessary modification that will be required based on the results of this inspection. We have no way of determining the number of airplanes that may need this modification:

What is the difference between the cost impact of this AD and the cost impact of AD 86-26-04? The difference is the addition of 26 airplanes to the applicability section of this AD. There is no difference in cost to perform the inspection and the modification.

Will this AD impact various entities? 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.

Will this AD involve a significant rule or regulatory action? 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 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 summary of the costs to comply with this AD and placed it in the AD Docket. You may get a copy of this summary by sending a request to us at the address listed under ADDRESSES. Include “AD Docket No. 2003-CE-40-AD” in your request.

This amendment to 14 CFR part 71 modifies the Class E airspace area extending upward from 700 feet above the surface at Fremont, NE. An examination of controlled airspace for Fremeont Municipal Airport revealed it does not meet the criteria for 700 feet AGL airspace required for diverse departures as specified in FAA Order 7400.2E, Procedures for Handling Airspace Matters. The criteria in FAA Order 7400.2E for an aircraft to reach 1200 feet AGL is based on a standard climb gradient of 200 feet per mile plus the distance from the airport reference point to the end of the outermost runway. Any fractional part of a mile is converted to the next higher tenth of a mile. The examination also identified discrepancies in the Fremont, NE Class E airspace legal description. This amendment expands the airspace area from a 7-mile radius to a 7.6-mile radius of Fremont Municipal Airport, corrects format errors in the legal description and brings the legal description of the Fremont, NE Class E airspace area into compliance with FAA Order 7400.2E. This area will be depicted on appropriate aeronautical charts. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9M, Airspace Designations and Reporting Points, dated August 30, 2004, and effective September 16, 2004, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

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

Interested parties are invited to participate in this rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2004-18818/Airspace Docket No. 04-ACE-44.” The postcard will be date/time stamped and returned to the commenter.

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

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

In a document published in the Federal Register of August 12, 2004 (69 FR 49784), the Commodity Futures Trading Commission (“Commission”) announced amendments to Commission rules relating to the minimum financial and related reporting requirements for futures commission merchants and introducing brokers. As discussed in the preamble, at page 49791, footnote 36, the amendments included technical corrections to revise references to “1.17(a)(1)(ii)” to read “1.17(a)(1)(iii)” within Rules 1.10(j)(8) and 1.17(a)(2), in order to reflect prior Commission rulemaking that had redesignated Rule 1.17(a)(1)(ii). However, these technical corrections were inadvertently omitted from the amendatory language in the published document, and the amendatory language also contained typographical errors. This document corrects both the omission and the typographical errors in the published document.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B) and (d)(3) the Coast Guard finds that good cause exists for not publishing an NPRM and making it effective less than 30 days after publishing in the Federal Register. Publishing an NPRM and waiting 30 days for it to be effective would be impracticable and contrary to the public interest as immediate action is necessary to protect event participants from the substantial dangers posed by vessels operating near the competition. For this reason, a temporary special local regulation is necessary to provide for the safety of life at sea during the event. In addition, advance notifications will be made via the Local Notice to Mariners, marine information broadcasts, and area newspapers.

On September 18, 2004, Associated Catholic Charities, Inc. will sponsor Dragon Boat Races in the Inner Harbor. The event will consist of 40 teams rowing Chinese Dragon Boats in heats of 2 to 4 boats for a distance of 400 meters. Due to the need for vessel control during the event, the Coast Guard will temporarily restrict vessel traffic in the event area to provide for the safety of participants, spectators and other transiting vessels.

The Coast Guard is establishing special local regulations on specified waters of the Patapsco River, Inner Harbor, Baltimore, MD. The regulations will be in effect from 6:30 a.m. to 6:30 p.m. on September 18, 2004. The effect will be to restrict general navigation in the regulated area during the event. Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area. Vessel traffic will be allowed to transit the regulated area at slow speed between heats, when the Coast Guard Patrol Commander determines it is safe to do so. These regulations are needed to control vessel traffic during the event to enhance the safety of participants, spectators and transiting vessels.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary.

Although this rule prevents traffic from transiting a portion of the Inner Harbor during the event, the effect of this rule will not be significant due to the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via the Local Notice to Mariners, marine information broadcasts, and area newspapers so mariners can adjust their plans accordingly. In addition, vessel traffic will be allowed to transit the regulated area at slow speed between heats, when the Coast Guard Patrol Commander determines it is safe to do so.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in the effected portions of the Inner Harbor during the event.

Although this regulation prevents traffic from transiting a portion of the Inner Harbor during the event, the effect of this regulation will not be significant because of the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via the Local Notice to Mariners, marine information broadcasts, and area newspapers so mariners can adjust their plans accordingly. In addition, vessel traffic will be allowed to transit the regulated area at slow speeds between heats, when the Coast Guard Patrol Commander determines it is safe to do so.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking process.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial and 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.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded under figure 2-1, paragraph (34)(h), of the Instruction, from further environmental documentation. Special local regulations issued in conjunction with a regatta or marine parade permit are specifically excluded from further analysis and documentation under those sections. Under figure 2-1, paragraph (34)(h), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule.

Norfolk Festevents will sponsor the “Chesapeake Bay Workboat Races” on the waters of the Elizabeth River on September 19, 2004. Approximately 25 traditional Chesapeake Bay deadrise workboats will race along an oval course in the Norfolk Harbor. A fleet of spectator vessels is expected. Therefore, to ensure the safety of participants, spectators, and transiting vessels, 33 CFR 100.501 will be enforced for the duration of the event. Under the provisions of 33 CFR 100.501, a vessel may not enter the regulated area unless it receives permission from the Coast Guard Patrol Commander. Vessel traffic will be allowed to transit the regulated area as the race progresses, when the Patrol Commander determines it is safe to do so.

In addition to this notice, the maritime community will be provided extensive advance notification via the Local Notice to Mariners, marine information broadcasts, and area newspapers, so mariners can adjust their plans accordingly.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B) and (d)(3), the Coast Guard finds that good cause exists for not publishing a NPRM and for making this regulation effective less than 30 days after publication in the Federal Register . Allowing for a comment period is impracticable and contrary to public interest, since immediate action is needed to protect mariners against potential hazards associated with dredging operations in the Marcus Hook Range Ship Channel and to modify the anchorage regulations to facilitate vessel traffic. However, advance notification will be made to affected mariners via marine information broadcasts.

The U.S. Army Corps of Engineers (USACE) conducts dredging operations on the Delaware River in the vicinity of the Marcus Hook Range Ship Channel to maintain the 40-foot project depth.

To reduce the hazards associated with dredging the channel, vessel traffic that would normally transit through the Marcus Hook Range Ship Channel will be diverted through part of Anchorage 7 off Marcus Hook (“Anchorage 7”) during the dredging operations. Therefore, additional requirements and restrictions on the use of Anchorage 7 are necessary. For the protection of mariners transiting in the vicinity of dredging operations, the Coast Guard is also establishing a safety zone around the dredging vessels, Weeks Dredge and Barge 312. The safety zone is intended to protect mariners from the potential hazards associated with dredging operations and equipment.

Currently paragraph (b)(2) of 33 CFR 110.157 allows vessels to anchor for up to 48 hours in the anchorage grounds listed in Section 110.157(a), which includes Anchorage 7. However, because of the temporary re-routing of vessel traffic through Anchorage 7, the Coast Guard is adding a paragraph (b)(11) in 33 CFR 110.157 to provide additional requirements and restrictions on vessels using Anchorage 7. During the effective period, vessels desiring to use Anchorage 7 must obtain permission from the Captain of the Port Philadelphia. Vessels should seek this permission at least 24 hours in advance. The Captain of the Port will permit only one vessel at a time to anchor in Anchorage 7 and will grant permission on a “first come, first served” basis. A vessel will be directed to a location within Anchorage 7 where it may anchor and will not be permitted to remain in Anchorage 7 for more than 12 hours.

Any vessel that is arriving from or departing for sea requiring an examination by the public health service, customs or immigration authorities will be directed to an anchorage for the required inspection by the Captain of the Port on a case by case basis.

When Anchorage 7 is occupied, the Coast Guard expects that vessels normally permitted to anchor in Anchorage 7 will use Anchorage 6 off Deepwater Point (“Anchorage 6”) or Anchorage 9 near the entrance to Mantua Creek (“Anchorage 9”), because they are the closest anchorage grounds to Anchorage 7. To control access to Anchorage 7, the Coast Guard is requiring a vessel desiring to anchor in Anchorage 7 obtain advance permission from the Captain of the Port. The Captain of the Port may be contacted by telephone at (215) 271-4807 or via VHF marine band radio, channels 13 and 16. To control access to Anchorages 6 and 9, the Coast Guard is requiring any vessel 700 feet or greater in length to obtain advance permission from the Captain of the Port before anchoring. The Coast Guard is also concerned that the holding ground in Anchorages 6 and 9 is not as solid as it is in Anchorage 7. Therefore, a vessel 700 to 750 feet in length is required to have one tug standing alongside while at anchor and a vessel over 750 feet in length must have two tugs standing alongside. The tug must be of sufficient size and horsepower to prevent an anchored vessel from swinging into the channel.

The Coast Guard is also establishing a safety zone within a 150-yard radius of the dredging operations being conducted in the Marcus Hook Range Ship Channel in the vicinity of Anchorage 7, by the Weeks Dredge Barge 312. The safety zone is intended to protect mariners transiting the area from the potential hazards associated with dredging operations. Vessels transiting the Marcus Hook Range Ship Channel will have to divert from the main ship channel through Anchorage 7 and must operate at the minimum safe speed necessary to maintain steerage and reduce wake. No vessel may enter the safety zone unless permission is received from the Captain of the Port.

This temporary rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary.

Although this regulation requires certain vessels to have one or two tugs alongside while at anchor, the requirement only applies to vessels 700 feet or greater in length that choose to anchor in Anchorages 6 and 9. Alternate anchorage grounds such as Anchorage A (Breakwater) and Anchorage 1 (Big Stone) in Delaware Bay, are reasonably close and generally available. Vessels anchoring in Anchorages A and 1 are not required to have tugs alongside, except when specifically directed to do so by the Captain of the Port because of a specific hazardous condition. Furthermore, few vessels 700 feet or greater are expected to enter the port during the effective period. The majority of vessels expected to anchor are less than 700 feet and thus will not be required to have tugs alongside.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. This rule's greatest impact is on vessels greater than 700 feet in length, which choose to anchor in Anchorages 6 and 9. This rule will have virtually no impact on any small entities. Therefore, the Coast Guard certifies under section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 605(b)) that this will not have a significant impact on a substantial number of small entities.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking.

Small businesses may send comments on the actions of Federal employees who enforce or otherwise determine compliance with Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guards, call 1-888-REG-FAIR (1-888-743-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule would not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and will not create an environmental risk to health or risk to safety that might disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would 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.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) 42 U.S.C. 4321-43701, and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore this rule is categorically excluded under figure 2-1, paragraph (34)(f) and (g) of the Instruction from further environmental documentation.

On August 23, 2004, we published a notice of proposed rulemaking (NPRM) entitled Safety Zone; Wiscasset, Maine, Demolition of Maine Yankee former containment building, in the Federal Register (69 FR 51785). We received no letters commenting on the proposed rule. No public meeting was requested, and none was held.

Under 5 U.S.C. 533 (d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Any delay in implementing this rule would be contrary to the public interest due to the risks inherent in the demolition of a large building by controlled implosion.

On July 20, 2004 representatives of Maine Yankee Nuclear Power Plant (“Maine Yankee”) presented the Coast Guard with plans for the demolition of a former containment building. Maine Yankee plans to use controlled explosive charges to bring down the containment building. The tentative date for this operation is September 17, 2004, but may be changed earlier or later, due to weather, winds, or other unforeseen changes in project scheduling. This safety zone will remain in effect approximately one hour before and one hour after the scheduled demolition. Due to hazards associated with the demolition of a large building, this temporary safety zone will be needed to ensure the safety of the maritime community and workers involved with the project during all portions of this evolution.

We did not receive any comments on this rulemaking.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

We expect the economic impact of this rule to be so minimal that a full regulatory evaluation under paragraph 10e of the regulatory policies and procedures of DHS is unnecessary. The effect of this regulation will not be significant for several reasons: There will be impact on the navigational channel for only a minimal amount of time, there will be ample space for vessels to navigate around the zone, and broadcast notifications will be made to the maritime community advising them of the boundaries of the zone before and during its effective periods.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in this safety zone during this demolition event. However, this rule will not have a significant economic impact on a substantial number of small entities due to the minimal time that vessels will be restricted from the area, the ample space available for vessels to maneuver and navigate around the zone, and advance notifications will be made to the local community by marine information broadcasts.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule would affect your small business, organization or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact Ensign J. B. Bleacher, Marine Safety Office Portland, at (207) 780-3251.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not effect a taking of private property or otherwise have taking implications under the Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize the litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children From Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it 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.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management system practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation.

A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES .

I. What Action Is EPA Taking Today?

EPA is announcing and promulgating revised designations for areas within Clark County, Nevada with respect to attainment or nonattainment of the 8-hour ozone National Ambient Air Quality Standard (NAAQS). This action modifies the designation for Clark County announced in our final 8-hour ozone designations rule published April 30, 2004. 69 FR 23858. In that final rule we designated all of Clark County as nonattainment for the 8-hour ozone NAAQS and provided the designation would be effective June 15, 2004. See 69 FR at 23919-20 (revising 40 CFR 81.329). We subsequently deferred the effective date for the Clark County designation until September 13, 2004 to allow further consideration of the appropriate nonattainment boundary. 69 FR 34076 (June 18, 2004). With today's action, we are designating a portion of Clark County as nonattainment for the 8-hour ozone NAAQS and the remainder of the County with the rest of the State as “unclassifiable/attainment.” The effective date of this designation is September 13, 2004.

On April 15, 2004, the EPA Administrator signed a final rule announcing designations under the 8-hour ozone NAAQS. 69 FR 23875 (April 30, 2004). In that action we designated Clark County as nonattainment and provided that this designation would become effective on June 15, 2004.

Following that notice, the State submitted additional information explaining that the boundaries of the area to be designated nonattainment should be reconsidered because of the unique circumstances that prevented the State from being able to evaluate the appropriate boundaries and submit an informed recommendation to EPA prior to the April 15, 2004 final 8-hour ozone designations. Letter from Allen Biaggi, Administrator, Nevada Division of Environmental Protection, to Michael O. Leavitt, Administrator, U.S. Environmental Protection Agency (June 9, 2004). 1 In the June 9, 2004 letter the State explained that it did not have time to make an appropriate recommendation regarding the boundaries of the nonattainment area in Clark County because it was not discovered until late February 2004 that any portion of Nevada would be designated nonattainment.

Based on the unusual history of the Clark County designation  2 and the subsequent information provided by the State, we concluded that the relevant factors for defining a nonattainment area might support a different boundary recommendation than the one originally submitted by the State and that a deferral of the effective date for the designation was reasonable to allow the State, Tribes, and EPA time to determine whether such an adjustment was reasonable. 69 FR at 34076.

Following EPA's decision to defer the effective date, EPA has worked closely with the State, County and Tribes to collect additional information and analyze the appropriate boundaries for the nonattainment area surrounding Las Vegas. We have received boundary recommendations with detailed information and analysis from the Nevada Division of Environmental Protection (NDEP or State) and from the Moapa Band of Paiutes (Moapa or Tribe). 3 Our analysis of these submittals is described in the Technical Support Document (TSD) for today's action and is summarized below. All of these submittals along with our TSD are available in the docket.

This section describes the statutory definition of nonattainment and EPA's guidance for determining air quality attainment and nonattainment areas for the 8-hour ozone NAAQS. In March 2000  4 and July 2000  5 we issued guidance on how to determine the boundaries for nonattainment areas. In that guidance, we rely on the CAA definition of a nonattainment area in section 107(d)(1)(A)(i) as an area that is violating an ambient standard or is contributing to a nearby area that is violating the standard. If an area meets this definition, EPA is obligated to designate the area as nonattainment.

In making designations and classifications, we use the most recent three years of monitoring data ( i.e. , 2001-2003), although other relevant years of data may be used in certain circumstances. 6 We treat data recorded by an ozone air quality monitor as representative of the air quality throughout the area in which the monitor is located and generally use the county as the basic jurisdictional unit in determining the extent of the area represented by the monitoring data. As a result, we typically designate the entire county and any nearby contributing area as nonattainment if an ozone monitor was measuring a violation of the standard based on the 2001-2003 data.

For violating monitors located in a Metropolitan Statistical Area (MSA) or Consolidated Metropolitan Statistical Area (CMSA), however, we typically designate the entire MSA or CMSA as nonattainment. Section 107(d)(4) of the Clean Air Act established the MSA or CMSA as the presumptive boundary for nonattainment areas when we promulgated our designation actions in 1991 for the 1-hour ozone standard. In our guidance on determining nonattainment area boundaries for the 8-hour ozone standard, we advised States that if a violating monitor is located in an MSA or CMSA (as defined by the Office of Management and Budget (OMB) in 1999), the larger of the 1-hour ozone nonattainment area or the MSA or CMSA should be considered in determining the boundary of a nonattainment area. 7 The MSA or CMSA defined by OMB generally shares economic, transportation, population, and other linkages that are similar to air quality related factors that produce ozone pollution. EPA concluded that using the MSA or CMSA as the presumptive boundary “best ensure[s] public health protection from the adverse effects of ozone pollution caused by population density, traffic and commuting patterns, commercial development, and area growth.” Memorandum from John S. Seitz, “Boundary Guidance on Air Quality Designations for the 8-Hour Ozone National Ambient Air Quality Standards” (March 28, 2002). This boundary, however, is only presumptive; a State may propose area boundaries smaller or larger than the presumptive area, and EPA will consider alternative boundary recommendations on a case-by-case basis to assess whether the recommendation is consistent with section 107(d)(1) of the Act. 8 Id.

Our guidance identifies the factors to be considered in making and assessing a recommendation to designate an area other than the presumptive area. The factors can be used to justify including additional counties, excluding counties within the presumptive area, or, as is the case for the Las Vegas area, defining an area that is less than the full county. The factors were compiled based on our experience in designating areas for the ozone standard in March 1978 and November 1991 and by looking to the CAA, section 107(d)(4), which states that the Administrator and the Governor shall consider factors such as population density, traffic congestion, commercial development, industrial development, meteorological conditions, and pollution transport. State and local agencies also had extensive input into compiling the factors.

The factors are:

(1) Emissions and air quality in adjacent areas (including adjacent MSAs and CMSAs),

(2) Population density and degree of urbanization including commercial development (significant difference from surrounding areas),

(3) Monitoring data representing ozone concentrations in local areas and larger areas (urban or regional scale),

(4) Location of emission sources (emission sources and nearby receptors should generally be included in the same nonattainment area),

(5) Traffic and commuting patterns,

(6) Expected growth (including extent, pattern, and rate of growth),

(7) Meteorology (weather/transport patterns),

(8) Geography/topography (mountain ranges or other air basin boundaries),

(9) Jurisdictional boundaries ( e.g., counties, air districts, existing 1-hour nonattainment areas, Reservations, etc.),

(10) Level of control of emission sources, and

(11) Regional emissions reductions ( e.g., NO X State Implementation Plan (SIP) Call or other enforceable regional strategies). 9

In July 2003, the State submitted its recommended designations for the 8-hour ozone designations. See Letter from Allen Biaggi, Administrator, Nevada Division of Environmental Protection to Wayne Nastri, Regional Administrator, U.S. EPA, Region IX (July 10, 2003). Based on the monitoring data provided by the State for the period of 2000 through 2002, the State concluded that all monitors within the State were showing compliance with the 8-hour ozone NAAQS. On December 3, 2003, EPA agreed with the State's recommendation not to designate any Nevada area as nonattainment for the 8-hour ozone standard. See Letter from Wayne Nastri, Regional Administrator, U.S. EPA, Region IX, to Hon. Kenny C. Guinn, Governor of Nevada (December 3, 2004). In that letter EPA noted that the final designation determination would be based on monitoring data and design values for the period 2001 through 2003, but that based on our preliminary review of the air quality monitoring data for the 2003 ozone season, there were no areas in Nevada violating the 8-hour ozone standard. Id.

In mid-February 2004, EPA discovered that the July 10, 2003 recommendation from the State had failed to include complete monitoring data for 2001. This overlooked data, in combination with the new 2003 data, resulted in a 2001-2003 design value over the applicable standard at one of the monitors (Joe Neal) in the Las Vegas area of Clark County. EPA contacted the State and described that, by default, the MSA that included Clark and Nye Counties in Nevada and Mohave County in Arizona should be recommended for designation as nonattainment.

Arizona and Nevada were able to prepare an analysis that supported the exclusion of Nye and Mohave Counties from the nonattainment area. See Letter from Allen Biaggi, Administrator, Nevada Division of Environmental Protection, to Wayne Nastri, Regional Administrator, U.S. EPA, Region IX (April 12, 2004) (transmitting NDEP's report entitled “Nevada Air Quality Designations and Boundary Recommendations for the 8-Hour Ozone National Ambient Air Quality Standard” (March 26, 2004)); Letter from Stephen A. Owens, Director, Arizona Department of Environmental Quality, to Wayne Nastri, Regional Administrator, U.S. EPA, Region IX (March 26, 2004) (transmitting report entitled “Arizona Boundary Recommendations for the 8-Hour Ozone National Ambient Air Quality Standard” (March 26, 2004)). As a result, three days before the EPA deadline for making designations, the State recommended that Clark County be designated nonattainment. 10 Id. EPA's April 30, 2004 final rule announcing the 8-hour ozone designations for the country designated all of Clark County as nonattainment and the rest of State as “unclassifiable/attainment.” 69 FR 23858, 23919-20 (April 30, 2004).

On August 2, 2004, the State submitted a revised recommendation for the boundary of the nonattainment area surrounding Las Vegas. Letter from Leo Drozdoff, Acting Administrator, NDEP, to Wayne Nastri, Regional Administrator. U.S. EPA, Region IX. Based on an analysis of the 11 factors outlined in EPA's guidance, the State recommended that the following hydrographic areas  11 within Clark County be designated nonattainment: Ivanpah Valley (hydrographic areas 164A, 164B, 165 and 166), Eldorado Valley (hydrographic area 167), Las Vegas Valley (hydrographic area 212), Colorado River Valley (hydrographic area 213), Paiute Valley (hydrographic area 214), Apex Valley (hydrographic areas 216 and 217), and a portion of Moapa Valley (hydrographic area 218). 12 The State recommended that the remainder of the County be designated “unclassifiable/attainment” because these areas:

• Are sparsely populated, containing less than two percent of the County population;

• Were not found to impact the recommended nonattainment area;

• Contain insignificant point and mobile sources of emissions;

• Are separated geographically and topographically from the recommended nonattainment area; and

• Are expected to have low regional ozone levels based on monitoring data.

The areas recommended as part of the nonattainment area contain all of the monitors reading elevated ozone concentrations, all of the major transportation corridors, nearly all of the major sources of ozone precursors in the County, and the vast majority of the County's population. The State considered likely transport of emissions in and out of the Las Vegas Valley and recommended including all areas with sources that may contribute to violations of the 8-hour standard in Las Vegas as well as surrounding areas that may be impacted by emissions from sources in and around Las Vegas.

We also received recommendations from the Moapa Band of Paiutes regarding designation of the Moapa River Indian Reservation located within Clark County, northeast of Las Vegas. Letter from Philbert Swain, Chairman, to John Kelly, U.S. EPA, Region IX (July 30, 2004); Letter from Thomas R. Wood, Stoel Rives, to Paul Cort, U.S. EPA, Region IX (Aug. 19, 2004) (transmitting supplement to the July 30, 2004 analysis). The Reservation overlaps with the hydrographic areas recommended as nonattainment by the State (Apex and Moapa Valleys), but the Tribe recommended designating the Reservation as attainment because:

• Emissions at the Reservation do not significantly impact local air quality;

• Emissions do not contribute to nonattainment in the Las Vegas Valley; and

• The area lacks any economic integration with Las Vegas.

Two other reservations are within the area recommended by the State as the nonattainment area. Specifically, in addition to the Moapa River Indian Reservation of the Moapa Band of Paiutes described above, the area includes the reservation lands of the Las Vegas Paiute and a small portion of the Fort Mojave Indian Reservation of the Fort Mojave Indian Tribe. We did not receive recommendations from the Las Vegas Paiute or the Fort Mojave Tribes, so we have prepared an independent assessment in accordance with our guidance and consulted with the Tribes to promulgate designations for these Reservations.

EPA agrees with the recommendation of the State to narrow the nonattainment designation for the Las Vegas area to the portion of Clark County defined by hydrographic areas 164A, 164B, 165, 166, 167, 212, 213, 214, 216, 217 and 218. 13 We therefore will designate the remainder of the County, as we have designated the rest of the State, as “unclassifiable/attainment” for the 8-hour ozone NAAQS.

The State has taken a broad and conservative approach in defining the portions of the 8,000-square mile County that cause of contribute to violations of the standard in the Las Vegas Valley. These areas include all portions of the County having any elevated concentrations of ozone and nearly every major source in the County. The areas recommended as part of the nonattainment area include 98 percent of the population and all of the urbanized and projected growth areas within the County. Finally, the area recommended for nonattainment includes the major traffic and commuting corridors within the County.

We also agree that the remainder of the County is reasonably excluded from the nonattainment area. It is primarily public land, with few sources, and no urbanization or likelihood of growth. Air quality in these surrounding areas is not impaired with respect to the 8-hour ozone NAAQS and there is no likelihood of contribution to the ozone problem in the Las Vegas area due to the lack of emission sources, geographical barriers and prevailing weather patterns. 14

The area recommended by the State for nonattainment overlaps with the reservation land of three Tribes: the Moapa Band of Paiutes, located in Moapa Valley northeast of Las Vegas; the Las Vegas Band of Paiutes, located within the Las Vegas Valley; and the Fort Mojave Indian Tribe, located at the southern tip of the County near the Arizona and California state lines. As noted above, we received a designation recommendation from the Moapa Band of Paiutes that argued for designating the Reservation in Moapa Valley as attainment. We consulted with the other Tribes but did not receive formal recommendations.

In accordance with our trust responsibilities for these Tribes, we independently evaluated whether these areas should be included or excluded from the nonattainment area within Clark County. We concluded that the Las Vegas Paiute land, given its location within the Las Vegas Valley, its meteorologic and economic integration with Las Vegas, and the impact on air quality within the Reservation due to emissions from Las Vegas, should be included in the Las Vegas 8-hour ozone nonattainment area. The other Tribal areas, however, are reasonably excluded. 15

The Moapa Band of Paiutes provided significant information demonstrating that: (1) The Reservation is sufficiently removed from the sources of emissions in and around Las Vegas such that air quality in the Reservation has not been adversely impacted, (2) the area is not economically integrated with the growth of the Las Vegas area, and (3) emissions from sources within the tribal area do not contribute to air quality problems in or around Las Vegas due to prevailing wind patterns. For these reasons, we agree the Moapa River Indian Reservation should be excluded from the Las Vegas 8-hour ozone nonattainment area.

The Fort Mojave Reservation is also reasonably excluded from the Las Vegas 8-hour ozone nonattainment area. The Reservation is located approximately 80 miles from the Las Vegas area in an upwind direction. Monitors located in this portion of the State have not measured elevated ozone concentrations. There is no likelihood of economic integration with Las Vegas and the Reservation does not have sources that contribute to nonattainment in the Las Vegas area.

We are revising 40 CFR 81.329 to specify the revised boundaries of the nonattainment area within Clark County, Nevada. As explained above, the Las Vegas nonattainment area will include hydrographic areas 164A, 164B, 165, 166, 167, 212, 213, 214, 216, 217, and 218. From this area we are excluding that portion within the Moapa River Indian Reservation and the Fort Mojave Indian Reservation. The remainder of Clark County, along with these reservations, will be included with the rest of the State as “unclassifiable/attainment.” EPA is making this change without notice and comment in accordance with section 107(d)(2) of the Clean Air Act, which exempts the promulgation of these designations from the notice and comment provisions of the Administrative Procedure Act.

The effective date for these designations codified in 40 CFR 81.329 will be September 13, 2004. Section 553(d) of the Administrative Procedure Act generally provides that rulemakings shall not be effective less than 30 days after publication except where a substantive rule relieves a restriction or where the agency finds good cause for an earlier date. 5 U.S.C. 553(d)(1) and (3). Without expediting the effective date for today's action, all of Clark County would be designated nonattainment effective September 13, 2004. This designation could create significant confusion and potential substantive obligations for portions of Clark County that are being removed from the nonattainment area in today's action. Even in the areas of Clark County that continue to be considered nonattainment in today's action, having two effective dates will create confusion regarding deadlines for submittals and may serve only to delay requirements for planning. The effective date for today's action is therefore justified under the APA because: (1) It relieves a restriction by narrowing the boundaries of the Las Vegas nonattainment area that would otherwise become effective on September 13, 2004; and (2) it is in the public interest to avoid confusion and delay associated with overlapping designations and effective dates.

As noted in our June 18, 2004 deferral action (69 FR 34076), we do not intend to extend the deadline for state implementation plan submission for the Las Vegas nonattainment area. EPA will address this deadline in a subsequent action but believes it is reasonable to require submission according to the same schedule to which the area would be subject without the deferred effective date. Likewise, the time by which attainment occurs should not be affected by the deferral.

The EPA is revising the 8-hour ozone designations for Clark County, Nevada. We are defining new boundaries for the Las Vegas nonattainment area and including the remaining portions of the County with the rest of the State as “unclassifiable/attainment.” We are amending 40 CFR 81.329 to reflect these revised designations.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether the regulatory action is “significant” and, therefore, subject to OMB review and the requirements of the Executive Order. The Order defines “significant regulatory action” as one that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Pursuant to the terms of Executive Order 12866, it has been determined that this rule is not a “significant regulatory action” because none of the above factors applies. As such, this final rule was not formally submitted to OMB for review.

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. This rule revises the nonattainment designations for Clark County, Nevada that were promulgated on April 15, 2004. The present final rule does not establish any new information collection burden apart from that required by law. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of today's final rule on small entities, small entity is defined as: (1) A small business that is a small industrial entity as defined in the U.S. Small Business Administration (SBA) size standards (see 13 CFR part 121); (2) a small governmental jurisdiction that is a government of a city, county, town, school district, or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. This rule revises the boundaries of the Las Vegas 8-hour ozone nonattainment area in Clark County, Nevada. The revision narrows the boundaries of the nonattainment area and will not impose any new requirements on small entities. After considering the economic impacts of today's final rule on small entities, I certify that this rule will not have a significant economic impact on a substantial number of small entities.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and Tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including Tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements. Today's final action does not include a Federal mandate within the meaning of UMRA that may result in expenditures of $100 million or more in any one year by either State, local, or Tribal governments in the aggregate or to the private sector, and therefore, is not subject to the requirements of sections 202 and 205 of the UMRA. It does not create any additional requirements beyond those of the 8-hour NAAQS for ozone (62 FR 38894; July 18, 1997), therefore, no UMRA analysis is needed. In this rule, EPA is narrowing the definition of the Las Vegas nonattainment area in Clark County, Nevada. No new controls will be imposed as a result of this action. Thus, this Federal action will not impose mandates that will require expenditures of $100 million or more in the aggregate in any one year.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. The CAA establishes the scheme whereby States take the lead in developing plans to meet the NAAQS. This rule will not modify the relationship of the States and EPA for purposes of developing programs to implement the NAAQS. Thus, Executive Order 13132 does not apply to this rule.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This final rule does not have “Tribal implications” as specified in Executive Order 13175. This rule concerns the classification and designation of areas as attainment or nonattainment for the 8-hour ozone standard. The CAA provides for States to develop plans to regulate emissions of air pollutants within their jurisdictions. The TAR gives Tribes the opportunity to develop and implement CAA programs such as programs to attain and maintain the 8-hour ozone NAAQS, but it leaves to the discretion of the Tribe whether to develop these programs and which programs, or appropriate elements of a program, they will adopt.

This final rule does not have Tribal implications as defined by Executive Order 13175. It does not have a substantial direct effect on one or more Indian Tribes, since no Tribe has implemented a CAA program to attain the 8-hour ozone NAAQS at this time. Furthermore, this rule does not affect the relationship or distribution of power and responsibilities between the Federal government and Indian Tribes. The CAA and the TAR establish the relationship of the Federal government and Tribes in developing plans to attain the NAAQS, and this rule does nothing to modify that relationship. Because this rule does not have Tribal implications, Executive Order 13175 does not apply.

Although Executive Order 13175 does not apply to this rule, EPA did conduct outreach with Tribal representatives regarding the designations. These discussions informed EPA about key Tribal concerns regarding designations as the rule was under development.

Executive Order 13045: “Protection of Children From Environmental Health and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. The final rule is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health risks or safety risks addressed by this rule present a disproportionate risk to children. Nonetheless, we have evaluated the environmental health or safety effects of the 8-hour ozone NAAQS on children. The results of this risk assessment are contained in the National Ambient Air Quality Standards for Ozone, Final Rule (62 FR 38855-38896, July 18, 1997; specifically, 62 FR 38854, 62 FR 38860 and 62 FR 38865).

This rule is not subject to Executive Order 13211, “Actions That Significantly Affect Energy Supply, Distribution, or Use,” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866. Information on the methodology and data regarding the assessment of potential energy impacts is found in Chapter 6 of U.S. EPA 2002, Cost, Emission Reduction, Energy, and Economic Impact Assessment of the Proposed Rule Establishing the Implementation Framework for the 8-Hour, 0.08 ppm Ozone National Ambient Air Quality Standard, prepared by the Innovative Strategies and Economics Group, Office of Air Quality Planning and Standards, Research Triangle Park, NC, April 24, 2003.

Section 12(d) of the National Technology Transfer Advancement Act of 1995 (NTTAA), Pub. L. 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards (VCS) in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by VCS bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable VCS. This action does not involve technical standards. Therefore, EPA did not consider the use of any VCS.

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. The 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 on or before the effective date of this rule. A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective September 13, 2004.

Section 307(b)(1) of the CAA indicates which Federal Courts of Appeal have venue for petitions of review of final actions by EPA. This section provides, in part, that petitions for review must be filed in the Court of Appeals for the District of Columbia Circuit (i) When the agency action consists of “nationally applicable regulations promulgated, or final actions taken, by the Administrator,” or (ii) when such action is locally or regionally applicable, if “such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.” The rule designating areas for the 8-hour ozone standard was “nationally applicable” within the meaning of section 307(b)(1) since it established designations for all areas of the United States for the 8-hour ozone NAAQS. Since today's final action revises one of the designations made in that nationwide rulemaking, any petitions for review must be filed in the Court of Appeals for the District of Columbia Circuit. At the core of the designations rulemaking is EPA's interpretation of the definition of nonattainment under section 107(d)(1) of the CAA. In determining which areas should be designated nonattainment (or conversely, should be designated “unclassifiable/attainment”), EPA used a set of 11 factors that it applied consistently across the United States. For the same reasons, the Administrator also determined that the final designations are of nationwide scope and effect for purposes of section 307(b)(1). This is particularly appropriate because in the report on the 1977 Amendments that revised section 307(b)(1) of the CAA, Congress noted that the Administrator's determination that an action is of “nationwide scope or effect” would be appropriate for any action that has “scope or effect beyond a single judicial circuit.” H.R. Rep. No. 95-294 at 323, 324, reprinted in 1977 U.S.C.C.A.N. 1402-03. Here, the scope and effect of the designations rulemaking extend to numerous judicial circuits since the designations apply to all areas of the country. In these circumstances, section 307(b)(1) and its legislative history calls for the Administrator to find the rule to be of “nationwide scope or effect” and for venue to be in the D.C. Circuit. Thus, any petitions for review of this final action must be filed in the Court of Appeals for the District of Columbia Circuit within 60 days from the date final action is published in the Federal Register .

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

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

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

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

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

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

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 at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/ .

In the Federal Register of July 2, 2003 (FR 39547) (FRL-7312-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2F6427) by Mitsui Chemicals, Inc., Chiyoda-ku, Tokyo, Japan. That notice included a summary of the petition prepared by Mitsui Chemicals, Inc., the registrant. One comment was received from a private citizen, in support of this notice.

The petition requested that 40 CFR 180.603 be amended by establishing a tolerance for combined residues of the insecticide dinotefuran, N -methyl- N '-nitro- N '-[(tetrahydro-3-furanyl)methyl)]guanidine and its metabolites DN [1-methyl-3-(tetrahydro-3-furylmethyl)]guanidine and UF [1-methyl-3-(tetrahydro-3-furylmethyl)urea], expressed as dinotefuran, in or on vegetable, leafy, except Brassica, group 4 at 5.0 parts per million (ppm).

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

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961) (FRL-5754-7).

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for combined residues of dinotefuran, N -methyl- N '-nitro- N '-[(tetrahydro-3-furanyl)methyl)]guanidine and its metabolites DN [1-methyl-3-(tetrahydro-3-furylmethyl)]guanidine and UF [1-methyl-3-(tetrahydro-3-furylmethyl)urea] expressed as dinotefuran on vegetable, leafy, except Brassica, group 4 at 5.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by dinotefuran are discussed in Table 1 of this unit as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies reviewed.

The dose at which NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the LOAELs of concern are identified is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

Three other types of safety or UFs may be used. “Traditional UFs,” the “special FQPA safety factor,” and the “ default FQPA safety factor.” By the term “traditional UF,” EPA is referring to those additional UFs used prior to FQPA passage to account for data base deficiencies. These traditional UFs have been incorporated by the FQPA into the additional safety factor for the protection of infants and children. The term “special FQPA safety factor” refers to those safety factors that are deemed necessary for the protection of infants and children primarily as a result of the FQPA. The “default FQPA safety factor” is the additional 10X safety factor that is mandated by the statute unless it is decided that there are reliable data to choose a different additional factor (potentially a traditional uncertainty factor or a special FQPA safety factor).

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (aRfD or cRfD) where the RfD is equal to the NOAEL divided by an UF of 100 to account for interspecies and intraspecies differences and any traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor or the default FQPA safety factor is used, 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 safety factor.

For non-dietary risk assessments (other than cancer) the UF is used to determine the 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). An example of how such a probability risk is expressed would be to describe the risk as one in one hundred thousand (1 X 10 -5 ), one in a million (1 X 10 -6 ), or one in ten million (1 X 10 -7 ). 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 dinotefuran used for human risk assessment is shown in following Table 2.

1. Dietary exposure from food and feed uses . Currently there are no tolerances established for dinotefuran on any commodity. Risk assessments were conducted by EPA to assess dietary exposures from dinotefuran 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 1-day or single exposure.

In conducting the acute dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: The dietary risk analyses incorporated tolerance level residues and assumed 100% of the leafy vegetables had been treated with dinotefuran. The acute risk estimates are below the Agency's level of concern ( < 100% aPAD) for the general U.S. population and all population subgroups.

ii. Chronic exposure . In conducting the chronic dietary risk assessment EPA used the DEEM software with the FCID, which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 CSFII, and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: The dietary risk analyses incorporated tolerance level residues and assumed 100% of the leafy vegetables had been treated with dinotefuran. The chronic risk estimates are below the Agency's level of concern ( < 100% cPAD) for the general U.S. population and all population subgroups.

iii. Cancer . Dinotefuran is classified as “not likely to be a carcinogen,” therefore, an exposure assessment for quantifying cancer risk was not conducted.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for dinotefuran 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 dinotefuran.

The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The Screening Concentration in Groundwater (SCI-GROW) model is used to predict pesticide concentrations in shallow ground water. For a screening-level assessment for surface water EPA will use FIRST (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate an index reservoir environment, and both models include 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 screen for sorting out pesticides for which it is unlikely that drinking water concentrations would 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), which are the model estimates of a pesticide's concentration in water. EECs derived from these models are used 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 dinotefuran they are further discussed in the aggregate risk sections below.

Based on the Index Reservoir Screening Tool (FIRST) and SCI-GROW models, the EECs of dinotefuran for acute exposures are estimated to be 75.78 parts per billion (ppb) for surface water and 5.06 ppb for ground water. The EECs for chronic exposures are estimated to be 20.97 ppb for surface water and 5.06 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).

Dinotefuran is proposed to be registered for use on the following residential non-dietary sites: Professional turf management, professional ornamental production, residential indoor, lawn and garden. The risk assessment was conducted using the following residential exposure assumptions: Outdoor uses for turf farms, golf courses and residential lawns, ornamentals and vegetable gardens.

There is a potential for exposure to homeowners in residential settings during the application of products containing dinotefuran. There is also a potential for exposure from entering areas previously treated with dinotefuran such as lawns where children might play, or golf courses, home gardens that could lead to exposures for adults. As a result, risk assessments have been completed for both residential handler and post-application scenarios.

Residential handlers may be exposed dermally and by inhalation during mixing, loading and application of dinotefuran for short-term durations. However, a short-term dermal endpoint was not identified. For this reason, and because the short-term and intermediate-term inhalation endpoints are the same, intermediate-term risks are assessed for residential handlers as a screen for their potential short-term exposures. Because common toxicity endpoints were identified for both dermal and inhalation routes, a combined risk from both routes of exposure is assessed. Combined risk was estimated by calculating an aggregate risk index (ARI). All residential handler estimated exposures meet or exceed the Agency's target ARI of 1, and are therefore, not of concern.

Residential post-application exposures are assumed to be mostly of short-term duration (1 to 30 days); although intermediate-term (1 to 6 months) exposures are possible. Because there are numerous dinotefuran use products and scenarios, those scenarios assessed were chosen to cover the major residential use sites (i.e. turf, home garden etc.) and highest use rates and exposures. The margins of exposure (MOEs) for post-application exposure to dinotefuran are above the target MOE of 100, and therefore, do not exceed Agency's level of concern for the following scenarios: (1) Exposure to adults and children from turf products; and (2) exposure to adults in vegetable gardens.

The Agency combines risks resulting from exposures to individual chemicals when it is likely they can occur simultaneously based on the use pattern and the behavior associated with the exposed population. For this assessment, the Agency has added together risk values for adults applying dinotefuran to residential lawns and then being exposed to the treated lawn. For children, dermal and incidental oral exposures from activities on treated lawn were combined. These are considered to represent worst case scenarios for co-occurring residential exposures.

The risks from the combined exposures of adults applying dinotefuran to residential lawns and then being dermally exposed from post-application activities on the treated lawn do not exceed the Agency's level of concern. Children's combined risks from activities on treated lawns do not exceed the Agency's level of concern.

4. Cumulative effects from substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to dinotefuran and any other substances and dinotefuran 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 dinotefuran 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 OPP concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/ .

1. In general . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using UF (safety) in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate.

2. Prenatal and postnatal sensitivity . Prenatal developmental toxicity studies in rats and rabbits provided no indication of increased susceptibility (qualitative or quantitative) of rat or rabbit fetuses to in utero exposure to dinotefuran. There was no indication of increased (quantitative) susceptibility in the fetuses as compared to parental animals in the two generation reproduction study. Qualitative susceptibility was observed in the reproduction study; however, the degree of concern is low because the observed effects are well characterized (decreased body weight, decreased thymus weight, and decreased grip strength) and there are clear NOAELs/LOAELs.

3. Conclusion . Although there is generally low concern and no residual uncertainties for pre- and/or postnatal toxicity resulting from exposure to dinotefuran, some uncertainty is raised by a deficiency in the data (lack of a NOAEL in the chronic dog study) and the need for a developmental immunotoxicity study (DIT).

The absence of a NOAEL for the chronic dog study and the need for a DIT study generate some uncertainty regarding the protectiveness of chronic regulatory endpoint and long-term level of concern. Accordingly, EPA does not have reliable data supporting adoption of a safety factor other than the default additional 10X factor as specified in FFDCA section 408(b)(2)(C). The chronic endpoint and long-term level of concern have therefore been generated using a overall safety/uncertainty factor of 1,000 (representing 100X for inter-and intra-species variation and an additional 10X pursuant to FFDCA section 408(b)(2)(C).

The Agency does not have similar concerns regarding acute, short-term, and intermediate term risk assessments. First, the absence of a NOAEL only occurred in a chronic study. Second, reliable data show that the DIT is unlikely to result in a NOAEL for acute, short-term, or intermediate term effects that is lower than the NOAELs currently being used to assess the risk from such effects. EPA has required a Developmental Immunotoxicity Study (DIT) with dinotefuran based on the changes in the thymus weight in offspring in the reproduction study and in adult rats and dogs. There is, however, little evidence to support a direct effect of dinotefuran on immune function. This is because lymphoid organ weight changes can be secondary to generalized toxicity (e.g., reductions in body weight, body weight gain, and/or food efficiency). In the reproduction study, decreased thymus weights were seen in offspring in the presence of decreased body weight only at the Limit Dose (10,000 ppm). In the 1-year dog study, decrease in thymus weight was seen in the absence of other toxicity, however, no decrease in thymus weight was seen in the subchronic study in dogs which was conducted at higher doses (i.e., the results of the 1-year study was not supported by the results of the 90-day study).

Further, the only evidence on dinotefuran's potential immunological effect is found in studies with prolonged exposure. In the reproduction study, the effect of concern [i.e, decrease in thymus weight in only one generation (F2)] was seen only following approximately 13 weeks of exposure to the parental animals at close to the Limit Dose (1,000 mg/kg). Similarly, thymus effects in the chronic dog study were only observable after long-term exposures, but were not seen in the 90-day dog study.

Finally, it is clear that DIT study, which is performed in the rat, will have to be conducted at high doses (close to the Limit Dose) to elicit a potential single dose effect and this will result in a potential NOAEL higher than that currently used for various risk assessments. As noted, in the rat reproduction study, effects only occurred at doses close to the Limit Dose (1,000 mg/kg/day). The Limit Dose is the maximum dose recommended for testing in the Series 870 Health Effects Harmonized Test Guidelines; toxic effects occurring only at or near the Limit Dose are of less concern for human health since they may be specifically related to the high dose exposure and may not occur at the much lower doses to which humans are exposed. Additionally, in the acute neurotoxicity study in the rat, the LOAEL was 750 mg/kg/day in females and 1,500 mg/kg/day in males based on reductions in motor activity indicating that high doses are required to elicit Dinotefuran-induced toxicity in rats.

The NOAELs in the critical studies selected for acute dietary (125 mg/kg/day), short term incidental oral (33 mg/kg/day), and intermediate term incidental oral and dermal (22 mg/kg/day) exposure scenarios are lower than the offspring NOAEL (241 mg/kg/day) in the reproduction study. Therefore, EPA is confident that the doses selected for these risk assessments will address the concerns for the thymus weight changes seen in the offspring in the reproduction study and will not underestimate the potential risk from exposure to dinotefuran.

The Agency believes there are reliable data showing that the regulatory endpoints are protective of children despite the need for a developmental neuorotoxicity study. Developmental neurotoxicity data received and reviewed for other compounds in this chemical class (neonicotinoids) including thiacloprid, clothianidin, and imidacloprid, indicate that the results of the required DNT study will not likely impact the regulatory doses selected for dinotefuran.

In addition, the acute and chronic dietary food exposure assessment utilized proposed tolerance level residues and 100% crop treated information for all commodities. By using these screening-level assessments, acute and chronic exposure/risks will not be underestimated. Furthermore, the dietary drinking water assessment (Tier 1 estimates) uses values generated by models and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations. Finally, the residential assessment for children's postapplication exposures is based upon maximum application rates in conjunction with chemical-specific study data and are not expected to underestimate risk.

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 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 + residential 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 the 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 the pesticide 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 residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to dinotefuran will occupy 0.68% of the aPAD for the U.S. population, 0.76% of the aPAD for females 13 years and older, 0.21% of the aPAD for infants < 1 year old, and 0.76% of the aPAD for children 3 to 5 years old. In addition, there is potential for acute dietary exposure to dinotefuran in drinking water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 3.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to dinotefuran from food will utilize 8.6% of the cPAD for the U.S. population, 4.4% of the cPAD for infants < 1 year old, 8.6% of the cPAD for children 3-5 years old and 9.4% of the cPAD for females 13-49 years old. In addition, there is potential for chronic dietary exposure to dinotefuran in drinking water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 4.

3. Short-term risk . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Dinotefuran is proposed for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures. For dinotefuran, short-term and intermediate-term aggregate risk assessments based on exposure from oral, inhalation, and dermal routes were considered. However, for short-term aggregate exposure assessment, oral and inhalation risk estimates cannot be combined due to the different bases of their endpoints; i.e., neurotoxicity for oral and decrease in body weight for inhalation. Also, because no systemic toxicity was seen at the limit dose in a 28-day dermal toxicity study, no quantification of short-term dermal risk is required. Therefore, a short-term aggregate risk assessment cannot be performed for dinotefuran. However, an intermediate-term aggregate risk assessment was performed as a screening level assessment, which will apply to short-term aggregate risk.

4. Intermediate-term risk . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Dinotefuran is proposed for uses that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate-term exposures for dinotefuran. An intermediate-term aggregate risk assessment was performed as a screening level assessment for adults and children.

The child subgroup with the highest estimated chronic dietary exposure (children 3-5 years old) was used to calculate the intermediate-term aggregate risk, including chronic dietary (food and drinking water) and residential dermal and oral exposures. All acceptable MOEs must be identical for all MOEs to be included in the intermediate-term risk assessment. Based on the toxicity endpoint information, all acceptable MOEs are 100, and an oral endpoint for hand-to-mouth residential exposure was identified. In this case, the chronic dietary endpoint (NOAEL) was used to incorporate dietary (food and water), and residential exposures in the aggregate risk assessment. An intermediate-term residential exposure scenario was identified and includes dermal and oral exposure routes. To complete the aggregate intermediate-term exposure and risk assessment, chronic dietary (food and drinking water) and residential dermal and oral exposures must be included.

For children's combined exposure on turf, the total residential MOE was estimated to be 590. The average (chronic) dietary exposure for the highest exposed child subgroup (children 3-5 years old) was estimated to be 0.0017 mg/kg/day. The aggregate risk assessment for intermediate-term exposure to children is summarized in the following Table 5.

Compared with the EECs, the aggregate intermediate-term DWLOC does not exceed Agency's level of concern for the subgroup population of children 3-5 years old.

For adults, the worst case intermediate-term aggregate risk assessment includes the following scenarios: (1) Dermal and inhalation exposures to residential handlers (i.e. M/L/A of liquids to lawns by hose-end sprayers); (2) dermal post-application exposures on treated lawns; and (3) oral dietary exposures (i.e. food + drinking water). Based on the toxicity endpoint information, the acceptable MOEs are not all identical. The intermediate-term inhalation endpoint has a UF/MOE of 1,000, because a NOAEL was not reached and a LOAEL was used instead, while the assessments for incorporating food, water and dermal exposures have UFs/MOEs of 100. In this case, the aggregate risk index (ARI) method was used to calculate DWLOC values for the adult aggregate intermediate-term risk assessment.

The highest estimated average (chronic) dietary exposure occurred with females 13-49 years old (i.e. 0.0019 mg/kg/day). The adult residential combined risks from dermal (ARI = 17) and inhalation (ARI = 970) exposures to residential handlers; and dermal postapplication exposures (ARI = 12) on treated lawns were assessed and combined. The aggregate risk assessment for intermediate-term exposure to adults is summarized in following Table 6.

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

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

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

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

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

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

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 at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/ .

In the Federal Register of July 7, 2004 (69 FR 40920) (FRL-7364-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0F6152) by E.I. DuPont de Nemours and Company, DuPont Agricultural Products, Barley Mill Plaza, Wilmington, DE 19880-0038. The petition requested that 40 CFR 180.439 be amended by establishing a tolerance for residues of the herbicide thifensulfuron methyl, (methyl-3-[[[[(4-methoxy-6-methyl-1, 3, 5, -triazin-2-yl)amino]carbonyl]amino]sulfonyl]-2-thiophenecarboxylate), in or on imazethapyr tolerant canola seed at 0.02 parts per million (ppm), cotton seed at 0.02 ppm, cotton gin trash at 0.02 ppm, and CDC triffid flax at 0.02 ppm. That notice included a summary of the petition prepared by E. I. DuPont de Nemours & Company, the registrant. There were no comments received in response to the notice of filing.

During the course of the review the Agency decided to correct the Company address and correct the listings for the commodities canola, cotton gin trash, cottonseed, and flax. The company address is changed to DuPont Crop Protection, Stine-Haskell Research Center, Newark, DE 19714. The listing of the commodities imazethapyr tolerant canola, cotton seed, cotton gin trash, and Crop Development Center (CDC) triffid flax are corrected to read canola, seed; cotton, gin byproducts; cotton, undelinted seed; and flax, seed; respectively.

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

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of thifensulfuron methyl on canola, seed at 0.02 ppm; cotton, gin byproducts at 0.02 ppm; cotton, undelinted seed at 0.02 ppm; and flax, seed at 0.02 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by thifensulfuron methyl are discussed in Table 1 of this unit as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies reviewed.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (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.

Three other types of safety or uncertainty factors may be used: “Traditional uncertainty factors;” the “special FQPA safety factor;” and the “ default FQPA safety factor.” By the term “traditional uncertainty factor,” EPA is referring to those additional uncertainty factors used prior to FQPA passage to account for database deficiencies. These traditional uncertainty factors have been incorporated by the FQPA into the additional safety factor for the protection of infants and children. The term“ special FQPA safety factor” refers to those safety factors that are deemed necessary for the protection of infants and children primarily as a result of the FQPA. The “default FQPA safety factor” is the additional 10X safety factor that is mandated by the statute unless it is decided that there are reliable data to choose a different additional factor (potentially a traditional uncertainty factor or a special FQPA safety factor).

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 an UF of 100 to account for interspecies and intraspecies differences and any traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor or the default FQPA safety factor is used, 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 safety factor.

For non-dietary risk assessments (other than cancer) the UF is used to determine the 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). An example of how such a probability risk is expressed would be to describe the risk as one in one hundred thousand (1 X 10 - 5 ), one in a million (1 X 10 - 6 ), or one in ten million (1 X 10 - 7 ). 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 thifensulfuron methyl used for human risk assessment is shown in Table 2 of this unit:

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.439) for the residues of thifensulfuron methyl, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from thifensulfuron methyl 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.

Dietary exposure estimates were conducted using the Lifeline model (Version 2.0) which incorporates consumption data from the USDA Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998. The 1994-1996, 1998 data are based on reported consumption of more than 20,000 individuals over two non-consecutive survey days. Foods as consumed are linked to EPA-defined food commodities using publicly available recipe translation files (developed jointly by USDA/ARS and EPA). Lifeline models individual dietary exposures over a season by selecting a new CSFII diary each day from a set of similar individuals, based on age and season attributes. Further information regarding the Lifetime model can be found at the following web site: http://www.LifelineTMgroup.org.

The following assumptions were used for the acute exposure assessments: Tolerance level residues, 100% crop treated (CT), and default processing factors. Percent crop treated (PCT) or anticipated residues were not used.

ii. Chronic exposure . Dietary exposure estimates were conducted using the Lifeline model (Version 2.0) which incorporates consumption data from the USDA Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998. The 1994-1996, 1998 data are based on reported consumption of more than 20,000 individuals over two non-consecutive survey days. Foods as consumed are linked to EPA-defined food commodities using publicly available recipe translation files (developed jointly by USDA/ARS and EPA). Lifeline models individual dietary exposures over a season by selecting a new CSFII diary each day from a set of similar individuals, based on age and season attributes. The Lifeline chronic dietary exposure estimate is based on an average daily exposure from a profile of 1,000 individuals over a one year period. Further information regarding the Lifetime model can be found at the following web site: http://www.LifelineTMgroup.org.

The following assumptions were used for the chronic exposure assessments: Tolerance level residues, 100% crop treated (CT), and default processing factors were used. Percent crop treated (PCT) or anticipated residues were not used.

iii. Cancer . Thifensulfuron methyl has no carcinogenic potential. It is classified as not likely to be carcinogenic to humans based on the lack of evidence of carcinogenicity in both the rat and the mouse studies. Therefore, a cancer risk quantitative assessment was not performed.

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

The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The SCI-GROW model is used to predict pesticide concentrations in shallow ground water. For a screening-level assessment for surface water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate an index reservoir environment, and both models include 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 screen for sorting out pesticides for which it is unlikely that drinking water concentrations would 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), which are the model estimates of a pesticide's concentration in water. EECs derived from these models are used 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 thifensulfuron methyl they are further discussed in the aggregate risk sections in Unit.III.E.

Based on the FIRST and SCI-GROW models, the EECs of thifensulfuron methyl for acute exposures are estimated to be 0.331 to 4.358 part per billion (ppb) for surface water and 0.00002 to 0.0003 ppb for ground water. The EECs for chronic exposures are estimated to be 0.047 to .618 ppb ppb for surface water and 0.00002 to 0.0003 ppb for ground water.

The Federal Communications Commission published a document amending parts 2 and 15 of the Commission's rules in the Federal Register of September 7, 2004 (69 FR 54027). This document corrects the Federal Register as it appeared.

In FR Doc. 04-19745, published on September 7, 2004 (69 FR 54027), the Commission is correcting § 2.948(a)(2).

This is a summary of the Commission's Order on Reconsideration and Fourth Report and Order in CC Docket Nos. 96-45, 97-21, and 02-6 released on July 30, 2004. The full text of this document is available for public inspection during regular business hours in the FCC Reference Center, Room CY-A257, 445 Twelfth Street, SW., Washington, DC 20554.

1. In this order, we address pending petitions for reconsideration filed by Sprint Corporation (Sprint), United States Telecom Association, Inc. (USTA), and MCI Worldcom, Inc. (MCI). Petitioners seek reconsideration of an order which, among other things, directed the Universal Service Administrative Company (Administrator or USAC) to cancel any funding commitments under the schools and libraries support mechanism that were made in violation of the Communications Act, as amended (the Act), and to recover from the service providers any funds that had already been distributed pursuant to an unlawful funding decision. For the reasons discussed below, we agree with petitioners that we should seek recovery from schools and libraries in certain instances, and therefore grant their petitions in part. We also resolve the limited question raised in the Second FNPRM , 69 FR 6181, February 10, 2004, in CC Docket No. 02-06 of from whom we will seek recovery of schools and libraries funds disbursed in violation of the statute or a rule. We modify our requirements in this area so that recovery is directed at whichever party or parties has committed the statutory or rule violation.

2. Based on the more fully developed record now before us, we conclude that recovery actions should be directed to the party or parties that committed the rule or statutory violation in question. We do so recognizing that in many instances, this will likely be the school or library, rather than the service provider. We thus grant the petitions for reconsideration in part, and deny the petitions to the extent they argue that recovery should always be directed at the school or library. This revised recovery approach shall apply on a going forward basis to all matters for which USAC has not yet issued a demand letter as of the effective date of this order, and to all recovery actions currently under appeal to either USAC or this agency. We do not intend to modify any recovery action in which the service provider has satisfied the outstanding obligation or for which USAC has already issued an initial demand letter.

3. We now recognize that the beneficiary in many situations is the party in the best position to ensure compliance with the statute and our schools and libraries support mechanism rules. At the time the Commission adopted the Commitment Adjustment Order, USAC had been distributing funds through the schools and libraries mechanism for only one year. The Commission and USAC then faced a limited range of situations in which statutory or rule violations had occurred requiring the recovery of funds. Thus, the Commission lacked a full appreciation for the wide variety of situations that could give rise to recovery actions in which the school or library would be the party most culpable. The school or library is the entity that undertakes the various necessary steps in the application process, and receives the direct benefit of any services rendered. The school or library submits to USAC a completed FCC Form 470, setting forth its technological needs and the services for which it seeks discounts. The school or library is required to comply with the Commission's competitive bidding requirements as set forth in §§ 54.504 and 54.511(a) of our rules and related orders. The school or library is the entity that submits FCC Form 471, notifying the Administrator of the services that have been ordered, the service providers with whom it has entered into agreements, and an estimate of the funds needed to cover the discounts to be provided on eligible services.

4. To be sure, service providers have various obligations under the statute and our rules as well. Among other things, the service provider is the entity that provides the supported service, and as such, must provide the services approved for funding within the relevant funding year. The service provider is required under our rules to provide beneficiaries a choice of payment method, and, when the beneficiary has made full payment for services, to remit discount amounts to the beneficiary within twenty days of receipt of the reimbursement check. But in many situations, the service provider simply is not in a position to ensure that all applicable statutory and regulatory requirements have been met. Indeed, in many instances, a service provider may well be totally unaware of any violation. In such cases, we are now convinced that it is both unrealistic and inequitable to seek recovery solely from the service provider.

5. We conclude that recovering disbursed funds from the party or parties that violated the statute or a Commission rule will further our goals of minimizing waste, fraud and abuse in the schools and libraries support mechanism. We are concerned that the current recovery requirements that are subject to petitions for reconsideration do not place sufficient incentive on beneficiaries to ensure compliance with all relevant statutory requirements and our implementing rules. Indeed, some parties note that under our current recovery procedures beneficiaries often do not directly bear the consequence of any failure to comply with our rules. We conclude that directing recovery actions to beneficiaries in those situations where the beneficiary bears responsibility for the rule or statutory violation will promote greater accountability and care on the part of such beneficiaries.

6. We believe that recovering disbursed funds from the party or parties that violated the statute or rule sufficiently addresses USTA's concern that our prior holding in the Commitment Adjustment Order was inequitable. We note, however, that contrary to USTA's claim that we had no rules providing the recovery of funds disbursed in violation of the statute or a rule, our debt collection rules have been in place for some time. And, as explained below, those rules are applicable to the situation presented here.

7. We direct USAC to make the determination, in the first instance, to whom recovery should be directed in individual cases. In determining to which party recovery should be directed, USAC shall consider which party was in a better position to prevent the statutory or rule violation, and which party committed the act or omission that forms the basis for the statutory or rule violation. For instance, the school or library is likely to be the entity that commits an act or omission that violates our competitive bidding requirements, our requirement to have necessary resources to make use of the supported services, the obligation to calculate properly the discount rate, and the obligation to pay the appropriate non-discounted share. On the other hand, the service provider is likely to be the entity that fails to deliver supported services within the relevant funding year, fails to properly bill for supported services, or delivers services that were not approved for funding under the governing FCC Form 471. We recognize that in some instances, both the beneficiary and the service provider may share responsibility for a statutory or rule violation. In such situations, USAC may initiate recovery action against both parties, and shall pursue such claims until the amount is satisfied by one of the parties. Pursuant to § 54.719(c) of the Commission's rules, any person aggrieved by the action taken by a division of the Administrator may seek review from the Commission.

8. We note that USAC's determination concerning which party should be the recipient of the demand letter does not limit the Enforcement Bureau's ability to take enforcement action for any statutory or rule violation pursuant to section 503 of the Act. Any recipient of the demand letter is obligated to repay the recovery amount by the deadlines described in the Commitment Adjustment Implementation Order. Failure to do so may subject such recipients to enforcement action by the Commission in addition to any collection action.

9. We also specifically address the issue of whether a service provider should be subject to a recovery action in situations where it is serving as a Good Samaritan. In light of our decision today, we anticipate that recovery would be directed in most instances to the school or library. We conclude that Good Samaritans should not be subject to recovery actions except in those situations where the Good Samaritan itself has committed the act or omission that violates our rules or the governing statute.

10. We briefly address petitioners' remaining arguments. First, USTA argues that the authorities on which the Commission relied, chiefly the OPM decision and the DCA, are inapplicable to the funds at issue and thus offer no support for our determination to seek repayment of funds disbursed to providers in violation of the Act. We cannot agree. The authority, as well as the responsibility, of the Government to seek repayment of wrongfully distributed funds is well established as a matter of federal law.

11. Although parties assert that the OPM decision is limited in its holding to funds disbursed from the general Treasury, and is therefore not relevant here because universal service funds are taken from a special fund that is not deposited in the Treasury, that is too narrow a reading of the principle found in OPM. Rather, the principle to be drawn from OPM is that the Commission cannot disburse funds in the absence of statutory authority. It is “ ‘central to the real meaning of the rule of law, [and] not particularly controversial’ that a federal agency does not have the power to act unless Congress, by statute, has empowered it to do so.” Thus, contrary to petitioners' argument, we are bound by statutory restrictions in the disbursement of the universal service fund regardless of whether such funds are drawn from the Treasury.

12. Moreover, the Commission's disbursement of funds in violation of the statute or a rule gives rise to a claim for recoupment. As the Commission stated in the Commitment Adjustment Order, the DCA imposes a duty on agencies to attempt to collect on such claims. Specifically, the DCA requires that “[t]he head of an executive, judicial, or legislative agency * * * shall try to collect a claim of the United States Government for money or property arising out of the activities of, or referred to, the agency.” Here, we find that the disbursement of funds in violation of the statute or a rule gives rise to claims that “arise out of the activities” of the Commission, i.e., the activity of ensuring that schools and libraries received discounts for telecommunications services, voice mail, Internet access, and internal connections pursuant to section 254(h). Therefore, we are obligated by law to seek recoupment of funds that were disbursed in violation of our statutory authority. In addition, parties' assertions that the collection mandate of the DCA is inapplicable to the schools and libraries universal service program because its direct application is limited to claims for money owing to the United States Treasury, is inaccurate. By its terms, the DCA is not limited to funds that are owed to the Treasury. The DCA defines “debt or claim” as funds which are “owed to the United States,” not merely those which are “owed to the U.S. Treasury.” In fact, the DCA defines a “claim” to include overpayments from an agency-administered program, such as the federal universal service program.

13. We therefore reject the Petitioners' argument that the authorities on which we relied in the Commitment Adjustment Order are inapplicable. We conclude that under these authorities, the Commission has an obligation to seek recovery of universal service funds disbursed in violation of the statute or a rule.

14. USTA argues that we unlawfully delegated our authority to recoup universal service funds disbursed in violation of the statute or a rule to the Administrator because this duty is not found in §§ 54.702 or 54.705 of the Commission's rules. We reject this argument. The Administrator oversees the administration of the schools and libraries support mechanism, including the administration of disbursing schools and libraries funds consistent with, and under the direction of, the Commission's rules and precedent. If the Administrator allows funds to be disbursed in violation of the statute or a rule, it is within the ambit of its administration and disbursement duties to seek recoupment in the first instance. Moreover, we note that the Commission retains its authority to seek final payment of its claim. Thus, we have not unlawfully delegated the Commission's authority to seek recoupment of funds disbursed in violation of the statute or a rule.

15. This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified “information collection burden for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

16. The Regulatory Flexibility Act of 1980, as amended (RFA), requires that a regulatory flexibility analysis be prepared for notice-and-comment rule making proceedings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).

17. An initial regulatory flexibility analysis (IRFA) was incorporated in the Second FNPRM. The Commission sought written public comment on the proposals in the Second FNPRM, including comment on the IRFA. No comments were received to the Second FNPRM or IRFA that specifically raised the issue of the impact of the proposed rules on small entities.

18. In this order, we now direct that recovery of funds disbursed to schools and libraries in violation of the Communications Act, or of a program rule, be sought from whichever party or parties have committed the violation. This has no effect on any parties who have not violated our rules, except to make more money available for them to obtain through the schools and libraries support program. It only imposes a minimal burden on small entities that have violated our rules by requiring them to return funds they received in violation of our rules. We believe that the vast majority of entities, small and large, are in compliance with our rules and thus will not be subject to efforts to any recover improperly disbursed funds.

19. Therefore, we certify that the requirements of the order will not have a significant economic impact on a substantial number of small entities.

20. In addition, the order and this final certification will be sent to the Chief Counsel for Advocacy of the SBA, and will be published in the Federal Register.

21. The Commission will not send a copy of this Order on Reconsideration and Fourth Report and Order pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

22. Pursuant to the authority contained in sections 1, 4(i), 4(j), and 254 of the Communications Act of 1934, as amended that this Order on Reconsideration and Fourth Report and Order in CC Docket No. 02-06 is adopted.

23. The Petitions for Reconsideration filed by MCI WorldCom, Inc., United States Telecom Association, and Sprint on November 8, 1999 are granted to the extent provided herein.

24. The terms of this Order on Reconsideration and Fourth Report and Order are effective September 17, 2004.

25. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Order on Reconsideration and Fourth Report and Order, including the Final Regulatory Flexibility Certification, to the Chief Counsel for Advocacy of the Small Business Administration.

The Federal Communications Commission published a document amending part 64 in the Federal Register of September 1, 2004 (69 FR 53346). This document corrects the “Rule Changes” section of the Federal Register summary as it appeared. In rule FR Doc. 04-19955 published on September 1, 2004 (69 FR 53346), make the following correction:

This final rule amends DFARS 207.105 to add corrosion prevention and mitigation to the areas that agencies must address in acquisition plans. The rule implements Section 1067 of the National Defense Authorization Act for Fiscal Year 2003 (Public Law 107-314), which requires DoD to prevent and mitigate corrosion during the design, acquisition, and maintenance of military equipment.

This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993.

This rule will not have a significant cost or administrative impact on contractors or offerors, or a significant effect beyond the internal operating procedures of DoD. Therefore, publication for public comment is not required. However, DoD will consider comments from small entities concerning the affected DFARS subpart in accordance with 5 U.S.C. 610. Such comments should cite DFARS Case 2004-D004.

The Paperwork Reduction Act does not apply because the rule does not impose any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

This interim rule amends DFARS Parts 207 and 219 to implement Section 801 of the National Defense Authorization Act for Fiscal Year 2004 (Public Law 108-136). Section 801 adds 10 U.S.C. 2382, which places restrictions on the use of an acquisition strategy that includes a consolidation of contract requirements with a total value exceeding $5,000,000.

This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993.

This rule is expected to have a beneficial impact on small business concerns. An initial regulatory flexibility analysis has been prepared consistent with 5 U.S.C. 603. The analysis is summarized as follows:

This interim rule amends the DFARS to implement Section 801 of the National Defense Authorization Act for Fiscal Year 2004. Section 801 adds 10 U.S.C. 2382, which places restrictions on the consolidation of two or more requirements of a DoD department, agency, or activity into a single solicitation and contract, when the total value of the requirements exceeds $5,000,000. The objective of the rule is to ensure that decisions regarding consolidation of contract requirements are made with a view toward providing small business concerns with appropriate opportunities to participate in DoD procurements as prime contractors and subcontractors. The rule does not duplicate, overlap, or conflict with any other Federal rules. DoD considers the restrictions on consolidation of contract requirements to be separate and distinct from the restrictions on contract bundling specified in the Federal Acquisition Regulation. There are no significant alternatives that would accomplish the objectives of 10 U.S.C. 2382. The impact on small entities is expected to be positive.

A copy of the analysis may be obtained from the point of contact specified herein. DoD invites comments from small businesses and other interested parties. DoD also will consider comments from small entities concerning the affected DFARS subparts in accordance with 5 U.S.C. 610. Such comments should be submitted separately and should cite DFARS Case 2003-D109.

The Paperwork Reduction Act does not apply because the rule does not impose any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

A determination has been made under the authority of the Secretary of Defense that urgent and compelling reasons exist to publish an interim rule prior to affording the public an opportunity to comment. This interim rule implements Section 801 of the National Defense Authorization Act for Fiscal Year 2004 (Public Law 108-136). Section 801 provides that a DoD department, agency, or activity may not execute an acquisition strategy that includes a consolidation of contract requirements with a total value exceeding $5,000,000, unless the senior procurement executive concerned conducts market research, identifies any alternative contracting approaches that would involve a lesser degree of consolidation, and determines that the consolidation is necessary and justified. Comments received in response to this interim rule will be considered in the formation of the final rule.

This interim rule amends DFARS Parts 209, 217, and 246 to implement Section 802 of the National Defense Authorization Act for Fiscal Year 2004 (Public Law 108-136). Section 802 requires DoD to prescribe in regulations a quality control policy for the procurement of aviation critical safety items and the modification, repair, and overhaul of those items. This interim rule—

○ Identifies the responsibilities of the head of the design control activity for quality control of aviation critical safety items and related services; and

○ Specifies that DoD may enter into a contract for the procurement, modification, repair, or overhaul of an aviation critical safety item only with a source approved by the head of the design control activity.

This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993.

DoD does not expect this rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because the rule primarily relates to internal DoD responsibilities for ensuring quality control in the procurement of aviation critical safety items and related services. Therefore, DoD has not performed an initial regulatory flexibility analysis. DoD invites comments from small businesses and other interested parties. DoD also will consider comments from small entities concerning the affected DFARS subparts in accordance with 5 U.S.C. 610. Such comments should be submitted separately and should cite DFARS Case 2003-D101.

The Paperwork Reduction Act does not apply because the rule does not impose any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

A determination has been made under the authority of the Secretary of Defense that urgent and compelling reasons exist to publish an interim rule prior to affording the public an opportunity to comment. This interim rule implements Section 802 of the National Defense Authorization Act for Fiscal Year 2004 (Public Law 108-136). Section 802 requires DoD to prescribe in regulations a quality control policy for the procurement of aviation critical safety items and the modification, repair, and overhaul of those items. Section 802 became effective upon enactment on November 24, 2003. Comments received in response to this interim rule will be considered in the formation of the final rule.

DoD published an interim rule at 69 FR 26508 on May 13, 2004, to implement Sections 826 and 827 of the National Defense Authorization Act for Fiscal Year 2004 (Public Law 108-136). The rule amended DFARS 225.7002-2 and 252.225-7012 to provide new exceptions to the domestic source requirements of the Berry Amendment (10 U.S.C. 2533a), as authorized by Sections 826 and 827 of Public Law 108-136. DoD received no comments on the interim rule. Therefore, DoD has adopted the interim rule as a final rule without change.

This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993.

DoD certifies that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because the exceptions to domestic source requirements authorized by the rule are limited to acquisitions of (1) Food, specialty metals, and hand or measuring tools needed to support contingency operations or to fulfill other urgent requirements; and (2) waste and byproducts of cotton or wool fiber for use in the production of propellants and explosives.

The Paperwork Reduction Act does not apply, because the rule does not impose any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

DoD published an interim rule at 68 FR 56561 on October 1, 2003, to implement Section 8021 of the DoD Appropriations Act for Fiscal Year 2003 (Public Law 107-248). Section 8021 revised the criteria for application of the Indian Incentive Program by establishing a >$500,000 threshold for contracts and subcontracts under which incentives may be paid; by authorizing incentive payments for subcontracts awarded to Native Hawaiian small business concerns; and by adding contracts and subcontracts for commercial items to the Program. Section 8021 of the DoD Appropriations Act for Fiscal Year 2004 (Public Law 108-87) and Section 8021 of the DoD Appropriations Act for Fiscal Year 2005 (Public Law 108-287) contain similar provisions.

Fourteen sources submitted comments on the interim rule. A discussion of the comments is provided below. Differences between the interim and final rules are addressed in the response to Comments 1 and 6.

1. Comment: Revise requirements for use of the Indian incentive clause at DFARS 252.226-7001, to require inclusion of the clause in all contracts and subcontracts exceeding $500,000, instead of the present requirement for inclusion of the clause in contracts and subcontracts exceeding $500,000 when “subcontracting opportunities may exist.” This change would eliminate the possibility that a subcontracting opportunity might be overlooked.

DoD Response: Concur. The recommended change has been made in the final rule at 226.104 and 252.226-7001(g).

2. Comment: The rule should include the statutory requirement for inclusion of the incentive clause in subcontracts exceeding $500,000 at any tier.

DoD Response: The rule requires inclusion of the clause, including the flowdown requirement, in all subcontracts exceeding $500,000. This covers all subcontracts exceeding $500,000 at all tiers.

3. Comment: The $500,000 threshold for inclusion of the incentive clause in contracts and subcontracts is restrictive and should be lowered to $100,000 or less.

DoD Response: Do not concur. The $500,000 threshold is consistent with the Appropriations Act provisions.

4. Comment: With regard to the requirement for subcontracted commercial items to be produced or manufactured in whole or in part by a Native firm, the phrase “produced or manufactured in whole or in part” should be clarified. Solutions offered were: Use of the manufacturing standards established by the North American Industry Classification System (NAICS) codes; use of a percentage such as that contained in the nonmanufacturer rule at FAR 19.102(f)(2); or a reference to the Small Business Administration regulations at 13 CFR 121.406.

DoD Response: Do not concur. Placing such a restriction on the eligibility of a subcontract awarded to a Native firm would be without statutory basis.

5. Comment: Can an Indian business provide a non-commercial item as a reseller for the actual manufacturer?

DoD Response: Neither the Appropriations Act provisions nor the DFARS rule place any manufacturing conditions on non-commercial items subcontracted under the Program.

6. Comment: The rule should clarify that Alaska Native Corporations are eligible for participation in Program.

DoD Response: The rule already provides for participation of Alaska Native Corporations, through the definitions of “Indian” and “Indian-owned economic enterprise” in the clause at 252.226-7001. Minor changes have been made to the definition of “Indian” to clarify this point.

7. Comment: Are businesses owned by individual Federally recognized American Indians eligible for participation in the Program, as well as those businesses owned by Federally recognized tribes and organizations?

DoD Response: Yes. The definitions at 252.226-7001 provide for participation by Indian-owned businesses that are individually owned or tribally owned.

8. Comment: The Indian Incentive Program should also be applied to DoD Family Housing Privatization contracts. Presently, the incentive clause cannot be included in these contracts, because the privatization contracts are not considered DoD contracts.

DoD Response: This comment is outside the scope of the DFARS rule. Therefore, no change has been made to the rule as a result of this comment.

This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993.

This rule may have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. DoD has prepared a final regulatory flexibility analysis. A copy of the analysis may be obtained from the point of contact specified herein. The analysis is summarized as follows:

This rule amends the DFARS to implement Section 8021 of the DoD Appropriations Act for Fiscal Year 2003 (Public Law 107-248), Section 8021 of the DoD Appropriations Act for Fiscal Year 2004 (Public Law 108-87), and Section 8021 of the DoD Appropriations Act for Fiscal Year 2005 (Public Law 108-287) pertaining to the Indian Incentive Program. The Program permits incentive payments to contractors, and subcontractors at any tier, that use Indian organizations, Indian-owned economic enterprises, and Native Hawaiian small business concerns as subcontractors. DoD received no comments on the initial regulatory flexibility analysis. However, as a result of comments received on the interim rule, the final rule includes a change that prescribes use of the Indian incentive clause at DFARS 252.226-7001 in all contracts and subcontracts exceeding $500,000, rather than in only those exceeding $500,000 for which subcontracting opportunities are deemed to exist at the time of award of the contract or subcontract. The rule requires that maximum practicable opportunity be provided for Indian organizations, Indian-owned economic enterprises, and Native Hawaiian small business concerns to receive subcontract awards; and provides that a contractor or subcontractor that awards a subcontract to such an entity may receive an incentive payment of 5 percent of the amount of the subcontract. There are no practical alternatives that would accomplish the objectives of the applicable statutes.

The Paperwork Reduction Act does not apply because the rule does not impose any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

This interim rule amends DFARS Subpart 237.1 to implement Sections 721 and 841 of the National Defense Authorization Act for Fiscal Year 2004 (Pub. L. 108-136).

Section 721 amends 10 U.S.C. 1091(a)(2) to provide permanent authority for DoD to enter into personal services contracts for health care at locations outside of DoD medical treatment facilities (such as military entrance processing stations). The law previously provided for this authority to expire on December 31, 2003.

Section 841 amends 10 U.S.C. 129b to add authority for DoD to enter into contracts for personal services that (1) are to be provided by individuals outside the United States to support DoD activities and programs outside the United States; (2) directly support the mission of a DoD intelligence or counter-intelligence organization; or (3) directly support the mission of the DoD special operations command. This authority applies if the services to be procured are urgent or unique and would not be practical to obtain by other means.

This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993.

DoD does not expect this rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. , because application of the rule is limited to personal services contracts for (1) health care at locations outside of DoD medical treatment facilities, or (2) urgent or unique services that are to be performed outside the United States, or are in direct support of intelligence missions, when it would not be practical for DoD to obtain these services by other means. Therefore, DoD has not performed an initial regulatory flexibility analysis. DoD invites comments from small businesses and other interested parties. DoD also will consider comments from small entities concerning the affected DFARS subpart in accordance with 5 U.S.C. 610. Such comments should be submitted separately and should cite DFARS Case 2003-D103.

The Paperwork Reduction Act does not apply because the rule does not impose any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

A determination has been made under the authority of the Secretary of Defense that urgent and compelling reasons exist to publish an interim rule prior to affording the public an opportunity to comment. This interim rule implements Sections 721 and 841 of the National Defense Authorization Act for Fiscal Year 2004 (Pub. L. 108-136). Section 721 provides permanent authority for DoD to enter into personal services contracts for health care at locations outside of DoD medical treatment facilities. Section 841 adds authority for DoD to enter into contracts for urgent or unique personal services that (1) are to be provided by individuals outside the United States to support DoD activities and programs outside the United States; (2) directly support the mission of a DoD intelligence or counter-intelligence organization; or (3) directly support the mission of the DoD special operations command. Sections 721 and 841 became effective upon enactment on November 24, 2003. Comments received in response to this interim rule will be considered in the formation of the final rule.

The provision at DFARS 252.209-7001, Disclosure of Ownership or Control by the Government of a Terrorist Country, implements 10 U.S.C. 2327, which prohibits DoD from entering into a contract with a firm that is owned or controlled by the government of a country that has repeatedly provided support for acts of international terrorism. This final rule amends the provision at DFARS 252.209-7001 to remove Iraq from the list of countries subject to the prohibition. This change is a result of the President's May 7, 2003, determination to suspend all sanctions against Iraq that apply to countries that have supported terrorism (Presidential Determination 2003-23, 68 FR 26459, May 16, 2003).

This rule was not subject to Office of Management and Budget review under Executive Order 12866, dated September 30, 1993.

This rule will not have a significant cost or administrative impact on contractors or offerors, or a significant effect beyond the internal operating procedures of DoD. Therefore, publication for public comment is not required. However, DoD will consider comments from small entities concerning the affected DFARS subpart in accordance with 5 U.S.C. 610. Such comments should cite DFARS Case 2003-D098.

The Paperwork Reduction Act does not apply because the rule does not impose any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

I. Background

Paragraph S7.9 of Federal Motor Vehicle Safety Standard (FMVSS) No. 108, Lamps, Reflective Devices, and Associated Equipment, specifies the requirements for motorcycle headlighting systems. Paragraph S7.9.6 specifies location requirements for motorcycle headlamps. S7.9.6.2(a) applies to motorcycles equipped with headlighting systems consisting of one headlamp; S7.9.6.2(b) applies to motorcycles equipped with headlighting systems consisting of two headlamps, each of which provides both an upper and lower beam; S7.9.6.2(c) applies to motorcycles equipped with headlighting systems consisting of two headlamps, one of which provides an upper beam and one of which provides a lower beam. For headlighting systems covered by subparagraphs (a) and (c), the upper beam light source is not permitted to be higher than the lower beam light source. Paragraph (b) is silent as to the upper beam light source location.

In a petition dated October 13, 1998, JAPIA asked NHTSA to eliminate the restriction on upper beam light source location in S7.9.6.2(a) and S7.9.6.2(c) to allow the upper beam light source to be mounted above the lower beam light source. 1 Additionally, JAPIA asked NHTSA to permit a motorcycle headlighting system consisting of a single headlamp (S7.9.6.2(a)) to contain two upper beam and two lower beam light sources for a total of four distinct light sources in a single headlamp. For headlighting systems consisting of two headlamps, the petition asked the agency to instead allow for four distinct headlamps, two of which would provide the upper beam, and the other two the lower beam.

In support of its first request, JAPIA stated that the restriction on the location of upper beam light source relative to the location of lower beam light source is not necessary because headlamps must be located at least 22 inches above the road surface and not more than 54 inches above the road surface. JAPIA stated that the upper beam light source would not present any visibility or conspicuity concerns anywhere within that location range. The petition further stated that the Economic Commission for Europe (ECE) lighting regulations  2 do not restrict location of the upper beam light source and that elimination of this restriction would facilitate international harmonization.

In support of its second request, JAPIA stated that the European Economic Community requirements in 93/92/EEC  3 allow for installation of four independent headlamps on motorcycles. Again, JAPIA stated that allowing this in the United States would facilitate international harmonization because it would allow for common design of headlamp systems in Europe and U.S.

We granted JAPIA's petition by letter dated May 21, 2001. The agency did not issue a notice of proposed rulemaking or any other rulemaking document subsequent to the granting of the petition.

After careful consideration, NHTSA has decided to withdraw this rulemaking.

The requirement that upper beam light sources be no higher than lower beam light sources is a longstanding one and applies across vehicle types. The purpose of the requirement is to help (for any particular vehicle design) ensure good visibility while driving with the lower beams. Generally, drivers can see further when the lower beam light sources are mounted higher. If a manufacturer selects a design in which upper and lower beam light sources are at different heights, the requirement ensures that the lower beam lights are mounted at the higher height, thereby providing slightly better visibility.

While we continue to believe that it might be appropriate at some point to consider changing the existing requirement, we have decided, on further consideration, that such a change should not be undertaken without additional analysis and research related to visibility and glare. Given the complexity of the issues involved, however, and considering agency priorities and allocation of limited resources available to best carry out the agency's safety mission, NHTSA has decided not to pursue further rulemaking on this issue at this time.

As to JAPIA's request to allow multiple lower and upper beam light sources within a single headlamp, that issue was resolved in an interpretation letter sent by the agency to Mr. Mills of Triumph Motorcycles on May 24, 2002. 4

In response to our March 15, 2004, notice (69 FR 12105) proposing to approve the International Nontoxic Composite Corporation's (INC) tungsten-bronze shot as nontoxic for hunting waterfowl and coots, a commenter asked that we identify the sectional density of the shot. In the preamble to the August 9, 2004, final rule (69 FR 48163), we responded to that comment and noted that the sectional density of a sample provided to us was 11.68 grams per cubic centimeter (g/cc). We did not intend that this would be a limitation or condition of approval, as sectional density is not a factor that we consider with respect to approvals. The approval was based on the percent composition, as stated in 50 CFR 20.21. We understand that INC intends to produce the shot at a sectional density of approximately 12.1 g/cc, as noted in INC's application for approval of tungsten-bronze shot as nontoxic.

Most corrections are sequential numbering errors and are enumerated in the regulatory text section below. One correction removes the listing of Devils Lake Wetland Management District from the State of South Dakota (50 CFR 32.71).

NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for the Groundfish Fishery of the Bering Sea and Aleutian Islands Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2004 limit of non-chinook salmon caught by vessels using trawl gear in the CVOA is 42,000 animals (§ 679.21(e)(7)(vii)). Regulations at § 679.21(e)(1)(i) allocate 7.5 percent of this amount, 3,150 animals, to the groundfish CDQ program as prohibited species quota reserve leaving 38,850 animals for the non-CDQ fishery. The CVOA is defined as that part of the BSAI that is south of 56°00′ N. lat. and between 163°00′ W. long. and 167°30′ W. long. (Figure 2 to 50 CFR part 679).

In accordance with § 679.21(e)(7)(vii), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2004 non-CDQ limit of non-chinook salmon caught by vessels using trawl gear in the CVOA has been reached. Consequently, the Regional Administrator is prohibiting fishing with non-CDQ trawl gear in the Chum Salmon Savings Area defined at Figure 9 to 50 CFR part 679.

As of August 11, 2004, 0 mt of the non-chinook salmon CDQ reserve has been caught by vessels using trawl gear in the CVOA. Therefore, CDQ participants are not yet prohibited from fishing with trawl gear in the Chum Salmon Savings Area.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such a requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay prohibiting fishing with non-CDQ trawl gear in the Chum Salmon Savings Area.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.21 and is exempt from review under Executive Order 12866.