On February 26, 2008, 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 Air Tractor, Inc. AT-200, 300, 400, 500, 600, and 800 series airplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on March 3, 2008 (73 FR 11369). The NPRM proposed to supersede AD 2002-25-09, which required the installation of an overturn skid plate (part number (P/N) 11411-1-500 or an FAA-approved equivalent P/N) in some production models including Models AT-402B, AT-502B, AT-602, and AT-802A airplanes. Since we issued AD 2002-25-09, we received a report of the bolts breaking in an overturn accident where they attach the forward end of the original design overturn skid plate to the airframe. This allowed the skid plate to rotate around the rear attach point and the forward end of the plate to enter the cockpit area. We are issuing this AD to prevent the front and rear connections of the overturn skid plate to the airplane from breaking, which could allow foreign debris to enter the cockpit during an airplane overturn. This condition, if not corrected, could lead to pilot injury.

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

We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial corrections. We have determined that these minor corrections:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We estimate that this AD affects 2,026 airplanes in the U.S. registry.

In determining the total cost on U.S. operators, we presume that all airplanes in the U.S. fleet have a skid plate installed (as required by AD 2002-25-09), and the only cost is to incorporate the modification kit P/N 11411-1-501. We estimate the following costs to do the modification of installing the overturn skid plate modification kit P/N 11411-1-501 to those planes that currently have the overturn skid plate installed:

Discussion

On March 4, 2008, 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 SR20 airplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on March 12, 2008 (73 FR 13157). The NPRM proposed to require an inspection and replacement as necessary of the heat exchanger. This AD results from the discovery of engine exhaust fumes in the cabin of CDC Model SR20 airplanes. We are issuing this AD to detect and correct leaks in the exhaust system, which could result in exhaust gases leaking into the cabin heating system. This condition could lead to carbon monoxide in the cabin and incapacitation of the pilot.

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

We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial corrections. We have determined that these minor corrections:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We estimate that this AD affects 713 airplanes in the U.S. registry.

We estimate the following costs to do the inspection:

We estimate the following costs to do any necessary replacement that would be required based on the results of the proposed inspection. We have no way of determining the number of airplanes that may need this replacement:

Warranty credit will be given to the extent specified in Cirrus Service Bulletin SB 2X-78-07 R1, Revision 1, dated December 18, 2007.

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

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

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

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

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

2. Is not a “significant rule” under 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 other information as included in the Regulatory Evaluation) 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 “Docket No. FAA-2008-0284; Directorate Identifier 2008-CE-006-AD” in your request.

On January 24, 2008, we issued AD 2008-03-06, Amendment 39-15355 (73 FR 5733, January 31, 2008). That AD required actions intended to address an unsafe condition on the products listed above.

Since we issued AD 2008-03-06, the European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued Emergency AD No. 2008-0053-E, dated March 5, 2008 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

You may obtain further information by examining the MCAI in the AD docket.

STEMME F & D has issued Service Bulletin A31-10-083, Am-Index: 01.a, dated February 26, 2008. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all information provided by the State of Design Authority and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

This AD is considered an interim action because we are not including a mandatory requirement to replace STEMME part number (P/N) M476 single-ear clamps in the fuel system with P/N 10M-181 single-ear clamps on all affected sailplanes unless a leak in the fuel system is found. The Administrative Procedure Act does not permit the FAA to “bootstrap” a long-term requirement into an urgent safety of flight action where the rule becomes effective at the same time the public has the opportunity to comment. The short-term action and the long-term action are analyzed separately for justification to bypass prior public notice.

After issuing this AD, we may initiate further AD action (notice of proposed rulemaking followed by a final rule) to require replacing all P/N M476 single-ear clamps in the fuel system with P/N 10M-181 single-ear clamps on all affected sailplanes by a specified time. Credit will be given in any subsequent action for the replacement done under this AD.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might have also required different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are described in a separate paragraph of the AD. These requirements take precedence over those copied from the MCAI.

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because a leak in the area of the fuel line was found, which could result in the possibility of fuel leaking into the engine compartment. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2008-0598; Directorate Identifier 2008-CE-031-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD.

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

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

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

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

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

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

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

Lloyd, Inc., 604 West Thomas Ave., Shenandoah, IA 51601, filed ANADA 200-332 that provides for the veterinary prescription use of BUTORPHIC (butorphanol tartrate) Injection in horses for the relief of pain associated with colic and postpartum pain. Lloyd, Inc.'s BUTORPHIC Injection is approved as a generic copy of TORBUGESIC, sponsored by Fort Dodge Animal Health, Division of Wyeth, under NADA 135-780. The ANADA is approved as of May 1, 2008, and 21 CFR 522.246 is amended to reflect the approval.

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

The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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

In the Federal Register of February 15, 1977 (the 1977 final rule) (42 FR 9286), FDA published a final rule establishing requirements for professional and patient labeling of hearing aids and governing conditions for sale of hearing aids (§ 801.420 and § 801.421 (21 CFR 801.421)). The regulations became effective on August 15, 1977. Section 801.421(b)(1) of the current regulations provides that, before the sale of a hearing aid to a prospective user, a hearing aid dispenser is to provide the prospective user with a copy of the User Instructional Brochure. Current § 801.420(c)(4) requires that technical data useful in selecting, fitting, and checking the performance of a hearing aid be provided in the brochure or in separate labeling that accompanies the device. The 1977 final rule further required that the technical data values provided in the brochure or other labeling be determined according to the test procedures established by the Acoustical Society of America (ASA) in the American National Standard “Specification of Hearing Aid Characteristics,” ANSI S3.22-1976 (ASA 70-1976), which was incorporated by reference in the regulation.

ANSI S3.22 (ASA 70-1976) established measurement methods and specifications for several important hearing aid characteristics. The standard provided a method of ascertaining whether a hearing aid, after being manufactured and shipped, met the specifications and design parameters stated by the manufacturer for a particular model, within the tolerance stated by the standard.

In 1982, ASA revised the standard (ANSI S3.22-1982) (ASA 70-1982). In a final rule published in the Federal Register of July 24, 1985 (50 FR 30153), FDA incorporated the revised standard into § 801.420(c)(4). ASA revised the standard again in 1987 (ANSI S3.22-1987) (ASA 70-1987). In a final rule published in the Federal Register of December 21, 1989 (54 FR 52395), FDA incorporated the revised standard into § 801.420(c)(4). In 1996, ASA revised the standard again (ANSI S3.22-1996) (ASA 70-1996). In a final rule published in the Federal Register of November 3, 1999 (64 FR 59618), FDA incorporated the revised standard into § 801.420(c)(4).

In 2003, ASA revised the standard again (ANSI S3.22-2003). The 1996 version of the standard was written prior to the development of digital hearing aids. Therefore, some of the test procedures described in the 1996 version of the standard, designed for assessment of analogue hearing aids, were modified to accommodate digital technology. The major differences between the two versions of the standard are as follows:

• In the 1996 standard, the gain control was set to a specific reference test position for automatic gain control (AGC) hearing aids and for all other types of hearing aids. In the 2003 standard, AGC hearing aids are tested in AGC mode only for those tests associated with AGC functions and are operated in non-AGC mode for all other tests.

• In the 2003 standard, the tolerance for setting the gain control to reference test setting (RTS) has been widened to ± 1.5 dB from ± 1.0 dB.

FDA is now incorporating the 2003 standard into § 801.420(c)(4). This will allow hearing aid manufacturers to use the up-to-date methods to determine the technical data values for hearing aids.

In this direct final rule, FDA is:

• Amending § 801.420(c)(4) to change the identification of the standard from “American National Standard ‘Specification of Hearing Aid Characteristics,’ ANSI S3.22-1996 (ASA 70-1996) (Revision of ANSI S3.22-1987)” to “American National Standard ‘Specification of Hearing Aid Characteristics,’ ANSI S3.22-2003 (Revision of ANSI S3.22-1996) (Includes April 2007 Erratum)”. FDA also is updating an address in this section, changing “1350 Piccard Dr., rm. 240,” to “1350 Piccard Dr., rm. 150,”.

• Removing § 801.420(d). This section requires that manufacturers submit to FDA for review their User Instructional Brochure and other labeling for each type of hearing aid on or before August 15, 1977. This section was included with the initial hearing aid rule in 1977. It was intended to provide for an initial FDA review of the labeling to meet the new requirements. This section is outdated and is no longer necessary.

In the Federal Register of November 21, 1997 (62 FR 62466), FDA announced the availability of the guidance document entitled “Guidance for FDA and Industry: Direct Final Rule Procedures” that described when and how FDA will employ direct final rulemaking. We believe that this rule is appropriate for direct final rulemaking because it is intended to make noncontroversial changes to existing regulations. We anticipate no significant adverse comment.

Consistent with FDA's procedures on direct final rulemaking, elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule that is identical to this direct final rule. The companion proposed rule provides a procedural framework within which the rule may be finalized in the event the direct final rule is withdrawn because of any significant adverse comment. The comment period for this direct final rule runs concurrently with the comment period of the companion proposed rule. Any comments received in response to the companion proposed rule will also be considered as comments regarding this direct final rule.

If we receive any significant adverse comment, we intend to withdraw this final rule before its effective date by publication of a notice in the Federal Register within 30 days after the comment period ends. A significant adverse comment is defined as a comment that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without change. In determining whether an adverse comment is significant and warrants terminating a direct final rulemaking, we will consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process in accordance with section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553). Comments that are frivolous, insubstantial, or outside the scope of the rule will not be considered significant or adverse under this procedure. For example, a comment recommending an additional change to the rule will not be considered a significant adverse comment, unless the comment states why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to part of a rule and that part can be severed from the remainder of the rule, we may adopt as final those parts of the rule that are not the subject of a significant adverse comment.

If we withdraw the direct final rule, all comments received will be considered under the companion proposed rule in developing a final rule under the usual notice-and-comment procedures under the APA (5 U.S.C. 552a et seq.). If we receive no significant adverse comment during the specified comment period, we intend to publish a confirmation document in the Federal Register within 30 days after the comment period ends.

This direct final rule is authorized by sections 201, 301, 501, 502, 701, and 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 371, and 374).

The agency has determined under 21 CFR 25.30(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this direct final rule is not a significant regulatory action as defined by the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. The direct final rule amends the existing hearing aid regulation to refer to the updated consensus standard that is used to determine the technical data in hearing aid labeling. It does not impose any new requirements. Communications from manufacturers to FDA show that they are prepared to comply with this standard immediately. The agency, therefore, certifies that the direct final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $127 million, using the most current (2006) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this direct final rule to result in any 1-year expenditure that would meet or exceed this amount.

This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections of information addressed in the direct final rule have been approved by OMB in accordance with the PRA under the regulations governing labeling of medical devices (21 CFR part 801, OMB control number 0910-0485).

FDA has analyzed this direct final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies 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. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this direct final rule. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only.

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule. Publishing an NPRM would be impracticable and contrary to public interest since immediate action is needed to minimize potential danger to the public during the event. The necessary information to determine whether the marine event poses a threat to persons and vessels was not provided with sufficient time to publish an NPRM. The danger posed by powerboat racing makes special local regulations necessary to provide for the safety of spectator craft and other vessels transiting the event area. For the safety concerns noted, it is in the public interest to have these regulations in effect during the event. The Coast Guard will issue broadcast notice to mariners to advise vessel operators of navigational restrictions. On scene Coast Guard and local law enforcement vessels will also provide actual notice to mariners.

Under 5 U.S.C. 553(d)(3) and for the same reasons, the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date would be contrary to public interest, because immediate action is needed to ensure the safety of the event participants, spectator craft and other vessels transiting the event area. However advance notification will be made to users of the Pasquotank River, via marine information broadcasts, Local Notice to Mariners, commercial radio stations and local area newspapers.

On June 6, 7, and 8, 2008, the Virginia Boat Racing Association will sponsor the “Carolina Cup Regatta”, on the waters of the Pasquotank River. The event will consist of approximately 75 inboard hydroplanes racing in counter clockwise heats around an oval race course. A fleet of spectator vessels is anticipated to gather nearby to view the competition. Due to the need for vessel control during the event, vessel traffic will be temporarily restricted to provide for the safety of event participants, spectators and transiting vessels.

The Coast Guard is establishing a special local regulation on specified waters of the Pasquotank River, Elizabeth City, North Carolina. The special local regulations include all waters from shoreline to shoreline, bound to the west by the Elizabeth City Draw Bridge and on the east by a line originating at a point along the shoreline at latitude 36°17′54″ N, longitude 076°12′00″ W, thence southwesterly to latitude 36°17′35″ N, longitude 076°12′18″ W at Cottage Point. All coordinates reference Datum NAD 1983. The special local regulation will be in effect from 7:30 a.m. to 6:30 p.m., June 6 through June 8, 2008. The effect will be to restrict general navigation in the regulated area during the power boat races. Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area during the enforcement period. The Patrol Commander will notify the public of specific enforcement times by marine band radio safety broadcast. These regulations are needed to control vessel traffic during the event to enhance the safety of event participants, spectators and transiting vessels.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

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 the regulatory policies and procedures of DHS is unnecessary.

Although this regulation restricts vessel traffic from transiting a segment of the Pasquotank River during the event, the effect of this regulation 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 marine information broadcasts, commercial radio stations and local area newspapers so mariners can adjust their plans accordingly.

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 affects the following entities, some of which may be small entities: The owners or operators of vessels intending to transit this section of the Pasquotank River during the event.

This rule would not have a significant economic impact on a substantial number of small entities for the following reasons. This rule will be enforced for only a short period, from 7:30 a.m. to 6:30 p.m. on June 6, 7 and 8, 2008. The regulated area will apply to a segment of the Pasquotank River adjacent to Elizabeth City. Marine Traffic may be allowed to pass through the regulated area with the permission of the Coast Guard Patrol Commander. In the case where the Patrol Commander authorizes passage through the regulated area during the event, vessels will be required to proceed at the minimum speed necessary to maintain a safe course that minimizes wake near the race course. Before the enforcement period, we would issue maritime advisories so mariners can adjust their plans accordingly.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the 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). 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 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 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 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 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.lD and Department of Homeland Security Management Directive 5100.1, which guide 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 event 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 checklist and a categorical exclusion determination are not required for this rule.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM. In conjunction with preparations for this exercise, the U.S. Navy and Coast Guard were not able to finalize the exercise scope, location, and timetables until April 23, 2008. Therefore, publishing of a proposed rule was not feasible. Nonetheless, the temporary establishment of the safety zones established by this rule is in the public interest.

For the same reasons, under 5 U.S.C. 553(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. Immediately implementing this rule promotes the public interest by protecting the maritime public and agency participants on the Piscataqua River during Frontier Sentinel 2008.

This rule establishes five fixed safety zones as well as moving safety zones for the duration of the exercise. The rule is necessary to protect the federal, state, local, and public entities on the Piscataqua River during Frontier Sentinel 2008, a large scale mine countermeasures exercise. The exercise area will encompass all waters of the Piscataqua River from the General Sullivan Bridge, U.S. Route 16, seaward to one mile past the Red “2KR” buoy at the mouth of the river. Within this exercise area, there will be numerous federal, state, and local vessels participating with divers and unmanned underwater vehicles (UUV). The UUV's will be monitored by Coast Guard, Navy, or state patrol vessels, designated with the blue and white Alpha (Diver Down) Flag.

The five fixed safety zones will be established where continuous diving operations will take place during the hours of the exercise. These fixed safety zones will be located near Gerrish Island, Kittery Point, Jaffrey Point, and Odiornes Point. The five temporary fixed safety zones will be enforced between the hours of 8 a.m. to 5 p.m. on June 9, 2008 through June 12, 2008:

All waters on the Piscataqua River enclosed by a box starting from a point located south of Kittery Point at latitude 43°04′41″ N, longitude 70°43′03″ W; thence to latitude 43°04′36″ N, longitude 70°43′02″ W; thence to latitude 43°04′40″ N, longitude 70°42′34″ W; thence to latitude 43°04′45″ N, longitude 70°42′36″ W; thence to the point of beginning.

All waters on the Piscataqua River enclosed by a box starting from a point located east of Jaffrey Point at latitude 43°03′48″ N, longitude 70°42′36″ W; thence to latitude 43°03′15″ N, longitude 70°42′39″ W; thence to latitude 43°03′15″ N, longitude 70°42′21″ W; thence to latitude 43°03′48″ N, longitude 70°42′28″ W; thence to the point of beginning.

All waters on the Piscataqua River enclosed by a box starting from a point located west of Gerrish Island at latitude 43°04′32″ N, longitude 70°42′09″ W; thence to latitude 43°04′13″ N, longitude 70°42′05″ W; thence to latitude 43°03′55″ N, longitude 70°42′04″ W; thence to latitude 43°03′59″ N, longitude 70°41′53″ W; thence to latitude 43°04′15″ N, longitude 70°41′56″ W; thence to the point of beginning.

All waters on the Piscataqua River enclosed by a box starting from a point located east of Odiornes Point at latitude 43°03′05″ N, longitude 70°42′45″ W; thence to latitude 43°02′32″ N, longitude 70°42′33″ W; thence to latitude 43°02′40″ N, longitude 70°42′34″ W; thence to latitude 43°02′40″ N, longitude 70°42′05″ W; thence to latitude 43°02′53″ N, longitude 70°42′19″ W; thence to the point of beginning.

All waters on the Piscataqua River enclosed by a box starting from a point located south of Gerrish Island at latitude 43°03′21″ N, longitude 70°41′24″ W; thence to latitude 43°02′46″ N, longitude 70°41′13″ W; thence to latitude 43°02′46″ N, longitude 70°39′27″ W; thence to latitude 43°03′32″ N, longitude 70°40′10″ W; thence to latitude 43°03′27″ N, longitude 70°40′28″ W; thence to the point of beginning.

All coordinates for these safety zones are North American Datum 1983 (NAD 83).

The temporary moving safety zones will be established as necessary to encompass Coast Guard, Navy, and state patrol vessels, with a radius of 100 yards, to ensure the safety of the maritime public from the hazards associated with the UUV operations. There may be as many as five simultaneous moving safety zones throughout the operation area. The establishment and enforcement of these zones will be announced via a Broadcast Notice to Mariners during the exercise timeframe. These vessels and their associated UUV's will be operating in the Piscataqua River from the General Sullivan, U.S. Route 16 bridge, seaward to the mouth of the river near one mile past the Red “2KR” Buoy. The vessels will be displaying an Alpha (Diver Down) Flag.

Mariners wishing to transit through the moving safety zones must contact the Captain of the Port (COTP) or the COTP's designated representative at telephone number 207-767-0303 or contact the designated Patrol Commander on VHF Channel 13 (156.7 MHz) or VHF channel 16 (156.8 MHz) to seek permission to do so. If permission is granted, all persons and vessels must comply with the instructions provided by the COTP or the COTP's designated representative.

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. The Coast Guard expects the economic impact of this rule to be so minimal that a full regulatory evaluation is unnecessary. The effect of this rule will not be significant for the following reasons: The safety zone will be of limited duration. The event is designed to avoid, as much as practicable, deep draft, fishing, and recreational boating traffic routes. Vessels may be authorized to transit the zone with permission of the COTP. Additionally, maritime advisories will be broadcast during the duration of the effective period. Extensive outreach has been conducted through the Area Maritime Security Committee, the Area Committee, and the Maine and New Hampshire Port Safety Forum, as well as focused outreach to key stakeholders.

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 in the safety zone during this exercise. 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 (Public Law 104-121), we want to assist small entities in understanding this temporary rule so that they can better evaluate its effects on them and participate in the rulemaking process. If this rule will affect your small business, organization or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact LTJG Kevin Miller at (207) 741-5431, Sector Northern New England, Waterways Management Division.

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). 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 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 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 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 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.lD 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 Checklist” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES.

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This section provides additional information by addressing the following questions:

On July 18, 1997, EPA promulgated revised NAAQS for ozone and PM. For ozone, EPA adopted a standard of 0.08 ppm over an 8-hour averaging period (62 FR 38856). For PM, EPA added new 24-hour and annual standards for particles less than or equal to 2.5 micrometers in diameter (PM2.5) (62 FR 38652). Section 110(a)(1) of the CAA requires states to submit new SIPs that provide for the implementation, maintenance, and enforcement of a new or revised standard within three years after promulgation of such standard, or within such shorter period as EPA may prescribe. Section 110(a)(2) lists the elements that such new SIPs must address, including section 110(a)(2)(D)(i), which applies to interstate transport of certain emissions. While section 110(a)(1) imposes the obligation upon states to make a SIP submission for a new or revised NAAQS, the contents of that submission may vary depending upon the facts and circumstances related to the specific NAAQS.

On April 25, 2005, EPA made a finding that states had failed to submit SIPs to satisfy the requirements of section 110(a)(2)(D)(i) of the CAA for the 8-hour ozone and PM2.5 NAAQS. See 70 FR 21147. This finding started a 2-year clock for promulgation by EPA of a Federal Implementation Plan (FIP), in accordance with section 110(c)(1), for any state that did not submit a SIP meeting the requirements of section 110(a)(2)(D)(i) for both the 8-hour ozone and PM2.5 NAAQS. If, prior to that time, a state made a submission to meet the requirements of section 110(a)(2)(D)(i) and EPA approved the submission, EPA would not be required to promulgate a FIP for that state.

EPA is approving the SIP revision submitted by MPCA on October 23, 2007, to address the requirements of section 110(a)(2)(D)(i) of the CAA. This section requires each state to submit a SIP which prohibits emissions that could adversely affect the air quality in another state. The SIP must prevent sources in the state from emitting pollutants in amounts which will: (1) Contribute significantly to nonattainment of the NAAQS in another state, (2) interfere with maintenance of the NAAQS in another state, (3) interfere with the plans in another state to prevent significant deterioration of air quality, and (4) interfere with the plans of another state to protect visibility.

EPA issued a guidance memorandum (Interstate Transport Guidance) on August 15, 2006, relating to SIP submissions to meet the requirements of section 110(a)(2)(D)(i) for the 8-hour ozone and PM2.5 NAAQS.1 As discussed below, Minnesota's analysis of its SIP with respect to the statutory requirements is consistent with this guidance.

The MPCA addressed the first two elements, relating to monitor interference with attainment and maintenance of the NAAQS, by asserting that Minnesota is covered by the FIP for the Clean Air Interstate Rule (CAIR). In the CAIR, EPA concluded that states meet their section 110(a)(2)(D)(i) obligations to address the “significant contribution” and “interference with the maintenance” requirements by complying with the CAIR requirements, either by submitting an approvable CAIR SIP or relying on the CAIR FIP.2 Consequently, Minnesota will not need to submit a separate SIP revision to satisfy the section 110(a)(2)(D)(i), since they are relying on the CAIR FIP. Minnesota is covered by the CAIR due solely to its influence on PM2.5 nonattainment in Chicago (Illinois), and was not determined by EPA to impact ozone nonattainment in any area.

The third element MPCA addressed was prevention of significant deterioration (PSD) of air quality in another state. All new sources in Minnesota are subject to the federal PSD permitting program. Minnesota has a delegated PSD program and therefore has been given the authority by EPA to implement and enforce the federal PSD program. The PSD program satisfies the requirement of section 110(a)(2)(D)(i) prohibiting interference with measures required to meet the implementation plan for any other state related to PSD. It should be noted that the entire state of Minnesota is attaining both the 8-hour ozone and PM2.5 NAAQS.

The fourth required element, relating to Minnesota's impact on visibility impairment in another state, will be addressed by Minnesota's regional haze SIP. MPCA concurs with EPA in concluding that it is currently premature to determine whether or not SIPs for 8-hour ozone or PM2.5 contain adequate provisions to prohibit emissions that interfere with measures in SIPS developed by other states to address visibility impairment.3 MPCA is currently accepting comments on a separate SIP revision that will fulfill Minnesota's requirements under EPA's regional haze rule and address the section 110(a)(2)(D)(i) requirement with respect to visibility. The State is on a schedule to submit this revision to EPA in July of 2008. Until this SIP is submitted, an accurate assessment regarding the impact of emissions and control measures on other states' SIPs cannot be made. When EPA takes action on Minnesota's regional haze SIP, EPA will also make a determination regarding the adequacy of the SIP in addressing section 110(a)(2)(D)(i) with respect to visiblilty.

Minnesota placed the section 110(a)(2)(D)(i) SIP on notice on September 4, 2007, and offered the opportunity for a public hearing. No public hearing was requested and no comments were received.

With this action, the non-regulatory text in 40 CFR 52.1220(e) is revised to reflect that MPCA addressed the elements of the CAA section 110(a)(2)(D)(i) submittal.

EPA is approving this revision submitted by Minnesota and is revising 40 CFR 52.1220(e) to reflect that the MPCA has adequately addressed the required elements of the CAA section 110(a)(2)(D)(i) SIP. Please note that if EPA receives adverse comments on part of this rule, and if that part can be severed from the remainder of the rule, EPA may adopt as final those parts of the rule that are not the subject of an adverse comment.

We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the state plan if relevant adverse written comments are filed. This rule will be effective August 1, 2008 without further notice unless we receive relevant adverse written comments by July 2, 2008. If we receive such comments, we will withdraw this action before the effective date by publishing a subsequent document that will withdraw the final action. All public comments received will then be addressed in a subsequent final rule based on the proposed action. The EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. If we do not receive any comments, this action will be effective August 1, 2008.

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 1, 2008. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

EPA is taking final action to partially approve, disapprove, and conditionally approve revisions to the South Carolina SIP (Regulation 61-62.1, Regulation 61-62.5 Standard No. 7, and Regulation 61-62.5 Standard No. 7.1) as submitted by South Carolina Department of Health and Environmental Control (DHEC) on July 1, 2005, which include changes to South Carolina's PSD and NNSR programs. EPA is now taking the following related actions:

On September 12, 2007 (72 FR 52037), EPA published a notice of proposed rulemaking (NPR) in the Federal Register, proposing to partially approve, disapprove, and conditionally approve revisions to the South Carolina SIP submitted by the State of South Carolina on July 1, 2005. The September 12, 2007, NPR provides additional information about the proposed South Carolina SIP revisions and the rationale for this final action. The public comment period for the proposed action ended on October 12, 2007. No comments were received on EPA's proposed action. Consistent with section 110(k) of the Clean Air Act (CAA), EPA is now taking final action to partially approve, disapprove and conditionally approve the July 1, 2005, SIP revision from South Carolina.

On December 31, 2002 (67 FR 80186), EPA published final rule changes to 40 Code of Federal Regulations (CFR) parts 51 and 52, regarding the CAA PSD and NNSR programs. On November 7, 2003 (68 FR 63021), EPA published a notice of final action on its reconsideration of the December 31, 2002, final rule changes. In that November 7, 2003, final action, EPA added the definition of “replacement unit,” and clarified an issue regarding plant-wide applicability limitations. Collectively, these EPA final actions are referred to as the “2002 NSR Reform Rules.” On June 13, 2007 (72 FR 32526), EPA took final action to revise the 2002 NSR Reform Rules to exclude the clean units and PCP provisions that were vacated by the United States Court of Appeals for the District of Columbia Circuit (DC Circuit Court) on June 24, 2005. Further, on December 21, 2007, EPA took final action on the portion of the 2002 NSR Reform Rules remanded by the DC Circuit Court, regarding the reasonable possibility and recordkeeping provision. The “reasonable possibility” provision identifies, for sources and reviewing authorities, the circumstances under which a major stationary source undergoing a modification that does not trigger major NSR must keep records. On December 21, 2007, EPA established that “reasonable possibility” exists where source emissions equal or exceed 50 percent of the CAA NSR significance levels for any pollutant (72 FR 72607). These changes became effective on January 22, 2008, and the final action on that provision explains the process that states should follow if a SIP revision is necessary.1

The July 1, 2005, submittal consists of changes to the South Carolina Air Pollution Control Regulations and Standards (South Carolina Regulations). Specifically, the proposed SIP revisions include changes to South Carolina Regulation 61-62.1 entitled “Definitions and General Standards;” Regulation 61-62.5, Standard No. 7 entitled “Prevention of Significant Deterioration;” and Regulation 61-62.5, Standard No. 7.1 entitled “Nonattainment New Source Review.” DHEC submitted this SIP revision in response to EPA's December 31, 2002, changes to the federal NSR program. EPA is now partially approving and disapproving certain portions of the July 1, 2005, SIP submittal, consistent with section 110(k)(3) of the CAA. EPA is also conditionally approving provisions of the July 1, 2005, SIP submittal consistent with section 110(k)(4) of the CAA. As part of the conditional approval, South Carolina will have twelve months from the date of EPA's final conditional approval of the SIP revisions in which to further revise its NNSR rules, as described herein, to be consistent with existing federal law.

More specifically, pursuant to section 110(k)(3), EPA is taking final action to: (1) Approve Section II of South Carolina Regulation 61-62.1 to allow for synthetic minor permits to be issued in nonattainment areas; (2) partially approve South Carolina's PSD program; and (3) disapprove all references to PCPs and clean units in South Carolina's PSD and NNSR programs. The PCP and clean unit references are all severable from the other provisions of South Carolina's PSD and NNSR programs. EPA is not approving any portion of South Carolina's rules regarding PCPs and clean units. Further, any use by South Carolina of the PCP, clean unit, or similar provisions, is, according to a federal appeals court, contrary to the CAA.

Pursuant to section 110(k)(4) of the CAA, EPA may conditionally approve a portion of a SIP revision based on a commitment from the State to adopt specific, enforceable measures no later than twelve months from the approval date of final conditional approval. If the State fails to make the changes within the twelve month period, EPA will issue a finding of disapproval. EPA is not required to propose the finding of disapproval. The necessary revisions to the South Carolina SIP will materially alter the existing SIP-approved rule, and, as a result, the State must also make a new SIP submittal to EPA for approval that includes the rule changes. As with any SIP revision, South Carolina must provide an opportunity for public notice and comment and allow for a public hearing (and any other procedures required by State law) on the proposed rule changes. If South Carolina timely revises its rules and submits the revised SIP submittal, EPA will process that SIP revision consistent with the CAA.

With regard to the conditional approval of the NNSR program, South Carolina must revise its rules to include a methodology for calculating emissions reductions to be used as offsets that includes a baseline for determining credit for emissions offsets that, at a minimum, meets the requirements set out in 40 CFR 51.165(a)(3)(i) and Appendix S section IV.C. The emission offsets provisions must also specify that the reductions must be surplus and cannot be used for offsets if they are otherwise required by the South Carolina SIP or other federal standards, such as the NSPS and NESHAP, including the MACT standards. As part of the conditional approval, South Carolina has committed to make these changes within the twelve month timeframe. Further, in the interim until the required State NNSR program changes are in effect, South Carolina has committed to utilize the requirements of the federal NNSR program outlined in 40 CFR part 51, Appendix S (see, Letter of Commitment from M. Reece, DHEC, to B. Banister, EPA, November 20, 2007, included in the docket for this action).

The September 12, 2007, NPR and the docket for this action provide more details about the SIP revisions being approved and the rationale for EPA's final action. For additional information on EPA's 2002 NSR Reform Rules, see, 67 FR 80186 (December 31, 2002), and http://www.epa.gov/nsr.

EPA is taking final action to partially approve, disapprove, and conditionally approve changes to the South Carolina Air Pollution Control Regulation 61-62.1 entitled “Definitions and General Standards;” Regulation 61-62.5, Standard No. 7 entitled “Prevention of Significant Deterioration;” and Regulation 61-62.5, Standard No. 7.1 entitled “Nonattainment New Source Review,” as submitted by the State of South Carolina on July 1, 2005, as revisions to the South Carolina SIP.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This final rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (59 FR 22951, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves state and local rules implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal standard.

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 1, 2008. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See, section 307(b)(2).)

Organization of This Document. The following outline is provided to aid in locating information in this preamble.

EPA is publishing the action without a prior proposed rule because we view this as a noncontroversial action and anticipate no adverse comment. However, in the “Proposed Rules” section of today's Federal Register, we are publishing a separate document that will serve as the proposed rule to extend the stay if adverse comments are received on this direct final action. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule, see the ADDRESSES section of this document. If EPA receives adverse comment, we will publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect. We would address all public comments in any subsequent final rule based on the proposed rule.

Categories and entities potentially regulated by this action are synthetic organic chemicals manufacturers and petroleum refineries. The New Source Performance Standards (NSPS) for equipment leaks of VOC in SOCMI and petroleum refineries affect the following categories of sources:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by the final amendments and new standards for equipment leaks of VOC in SOCMI and petroleum refineries. To determine whether your facility is regulated by this action, you should examine the applicability criteria in 40 CFR 60.480, 60.590, 60.480a, and 60.590a. If you have any questions regarding the applicability of the NSPS to a particular entity, contact the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

Submitting CBI. Do not submit this information to EPA through www.regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information on a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

Docket. The docket number for this action and the final SOCMI and petroleum refineries equipment leak NSPS (40 CFR part 60, subparts VV, VVa, GGG, and GGGa) is Docket ID No. EPA-HQ-OAR-2006-0699.

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

On November 16, 2007, EPA promulgated amendments and established new standards of performance for equipment leaks of VOC in the SOCMI and Petroleum Refineries (72 FR 64860). Following the promulgation of the final amendments and new standards for these industries, EPA received a petition for reconsideration on January 15, 2008 from the American Chemistry Council (ACC), the American Petroleum Institute (API), and the National Petrochemical and Refiners Association (NPRA) (“Petitioners”). The petitioners, pursuant to CAA section 307(d)(7)(B), requested EPA reconsider four provisions in the rules: (1) The clarification of the definition of process unit in subparts VV, VVa, GGG, and GGGa; (2) the assigning of shared storage tanks to specific process units in subparts VV, VVa, GGG, and GGGa; (3) the connecter monitoring requirements in subpart VVa; and (4) the definition of capital expenditure in subpart VVa. The petitioners also requested that EPA stay the effectiveness of these provisions of the rule pending resolution of their petition for reconsideration. The petition can be found in the public docket (EPA-HQ-OAR-2006-0699).

On March 4, 2008, EPA sent a letter to the petitioners, through their counsel, informing them that EPA was granting their request for reconsideration on three of the issues listed above. We indicated in the letter that no action was being taken on the issue of the clarification of the definition of process unit at that time. Finally, the letter indicated that EPA was granting a 90-day stay of the provisions of the rules under reconsideration (see CAA section 307(d)(7)(B)), as well as the clarification of the definition of process unit, because of its interaction with the new provision regarding the allocation of shared storage vessels. The letter from EPA to the petitioners can be found in the public docket (EPA-HQ-OAR-2006-0699).

Today's action extends the stay of the provisions under reconsideration and the stay of the clarification of the definition of process unit. As noted above, EPA granted a 90-day stay of these provisions under CAA section 307(d)(7)(B) on March 4, 2008. That stay expires on June 1, 2008. We are extending the stay until we have reached a final decision on all of the issues raised in the petition for reconsideration. While the Agency does not generally grant stays pending reconsideration, we believe that the unique compliance issues created by our final rule warrant a limited stay pending reconsideration. As we explained in granting the initial stay:

As these reasons remain valid, we have decided to extend the limited stay for the remainder of our reconsideration process.

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

This action does not impose any new information collection burden. This action results in no changes to the information collection requirements of the NSPS and will have no impact on the information collection estimate of project cost and hour burden made and approved by OMB. However, OMB has previously approved the information collection requirements contained in the existing regulations at 40 CFR part 60, subparts VV and GGG under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501, et seq., and has assigned OMB control number 2060-0443, to the ICR for subpart VV and OMB control number 2060-0067, to the ICR for subpart GGG. 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 Procedures Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of the equipment leak NSPS on small entities, small entity is defined as: (1) A small business according to Small Business Administration size standards by the North American Industry Classification System (NAICS) category of the owning entity; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise that is independently owned and operated and is not dominant in its field. For the SOCMI, a small business ranges from less than 500 employees to less than 1,000 employees, depending on the NAICS code. For petroleum refiners, a small business has no more than 1,500 employees.

After considering the economic impacts of this action on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This action will not impose any requirements on any entities because it does not impose any additional regulatory requirements.

Title II of the Unfunded Mandates Reform Act (UMRA) of 1995, 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 by state, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted.

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

EPA has determined that this action contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local, or tribal governments or the private sector. This action imposes no enforceable duty on any State, local or tribal governments or the private sector. Thus, this action is not subject to the requirements of sections 202 and 205 of the UMRA.

EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. This rule only extends the stay of certain provisions and does not impose any additional enforceable duty.

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 action 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. This action will not impose direct compliance costs on State or local governments, and will not preempt State law. Thus, Executive Order 13132 does not apply to this action.

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 action does not have tribal implications, as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action.

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This action is not subject to Executive Order 13045 because the equipment leak NSPS for SOCMI and petroleum refineries are based on technology performance.

This action is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

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

EPA is not proposing to make any changes to the regulatory requirements in the final equipment leak NSPS in this action, including requirements that involve technical standards. As a result, the NTTAA discussion set forth in the November 16, 2007, final rule remains valid. The requirements of NTTAA, therefore, do not apply to this action.

Executive Order 12898 (59 FR 7629, February 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.

EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective August 1, 2008.

Regulated Entities. Categories and entities potentially regulated by this action are synthetic organic chemicals manufacturers and petroleum refineries. The New Source Performance Standards (NSPS) for equipment leaks of VOC in SOCMI and petroleum refineries affect the following categories of sources:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by the final amendments and new standards for equipment leaks of VOC in SOCMI and petroleum refineries. To determine whether your facility is regulated by this action, you should examine the applicability criteria in 40 CFR 60.480, 60.590, 60.480a, and 60.590a. If you have any questions regarding the applicability of the NSPS to a particular entity, contact the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

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

Organization of This Document. The following outline is provided to aid in locating information in this preamble.

On November 16, 2007, EPA promulgated amendments and established new standards of performance for equipment leaks of VOC in the SOCMI and Petroleum Refineries (72 FR 64860). Following the promulgation of the final amendments and new standards for these industries, EPA received a petition for reconsideration on January 15, 2008 from the American Chemistry Council (ACC), the American Petroleum Institute (API), and the National Petrochemical and Refiners Association (NPRA) (“Petitioners”). The petitioners, pursuant to CAA section 307(d)(7)(B), requested EPA reconsider four provisions in the rules: (1) The clarification of the definition of process unit in subparts VV, VVa, GGG, and GGGa; (2) the assigning of shared storage tanks to specific process units in subparts VV, VVa, GGG, and GGGa; (3) the connecter monitoring requirements in subpart VVa; and (4) the definition of capital expenditure in subpart VVa. The petitioners also requested that EPA stay the effectiveness of these provisions of the rule pending resolution of their petition for reconsideration. The petition can be found in the public docket (EPA-HQ-OAR-2006-0699).

On March 4, 2008, EPA sent a letter to the petitioners, through their counsel, informing them that EPA was granting their request for reconsideration on three of the issues listed above. We indicated in the letter that no action was being taken on the issue of the clarification of the definition of process unit at that time. Finally, the letter indicated that EPA was granting a 90-day stay of the provisions of the rules under reconsideration (see CAA section 307(d)(7)(B)), as well as the clarification of the definition of process unit, because of its interaction with the new provision regarding the allocation of shared storage vessels. The letter from EPA to the petitioners can be found in the public docket (EPA-HQ-OAR-2006-0699).

In the Final Rules section of today's Federal Register, we have published a direct final rule extending the stay until a final decision on the reconsideration has been reached. In the Proposed Rules section of today's Federal Register, we have also published a parallel proposal extending the stay until a final decision on the reconsideration has been reached. Based on today's direct final and parallel proposal extending the stay, we are taking this final action, effective for 60 days, beginning on publication, to prevent facilities from being out of compliance with provisions, at least some of which, we anticipate modifying upon reconsideration.

EPA is providing the public with an opportunity to comment on the stay extension in both the direct final rule and parallel proposal. However, we are not taking comment on this final action. We believe it is appropriate to continue the stay that is currently in place until the direct final action becomes effective to avoid a lapse in the stay and create potential compliance problems with provisions that we believe may need to be revised.

We are making an interim final determination to extend the stay for 60 days based on our concurrent direct final action and parallel proposal. EPA has determined that a stay is necessary for the provisions under reconsideration. The 90-day stay that began on March 4, 2008 expires on June 1, 2008. At that time, facilities will be required to comply with the final rules as published (72 FR 64860) unless an extension is set in place. EPA is invoking the good cause exception under the Administrative Procedure Act (APA) in not providing an opportunity for comment before this action takes effect (5 U.S.C. 553(b)(3)).

EPA believes that notice-and-comment rulemaking before the effective date of this action is impracticable and contrary to the public interest. EPA has stated in our letter to the Petitioners the reasons for granting the 90-day stay. As these reasons remain valid, we believe it is still appropriate for the stay to be in effect until we have reached a final decision on the reconsideration. Because the initial stay expires on June 1, 2008 and the direct final action would not be effective until 60 days after publication, it is not in the public's best interest to require compliance with the rules as published during the gap between the two dates. Therefore, EPA believes that it is necessary to use the interim final rulemaking process to extend the initial stay while the public has an opportunity to comment on the direct final action.

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

This action does not impose any new information collection burden. This action results in no changes to the information collection requirements of the NSPS and will have no impact on the information collection estimate of project cost and hour burden made and approved by OMB. However, OMB has previously approved the information collection requirements contained in the existing regulations at 40 CFR part 60, subparts VV and GGG under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501, et seq., and has assigned OMB control number 2060-0443, to the ICR for subpart VV and OMB control number 2060-0067, to the ICR for subpart GGG. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

Today's interim final rule is not subject to the Regulatory Flexibility Act (RFA), which generally requires an agency to prepare a regulatory flexibility analysis for any rule that will have a significant economic impact on a substantial number of small entities. The RFA applies only to rules subject to notice and comment rulemaking requirements under the Administrative Procedure Act (APA) or any other statute. This rule is not subject to notice and comment requirements under the APA or any other statute because although the rule is subject to the APA, the Agency has invoked the “good cause” exemption under 5 U.S.C. 553(b), therefore it is not subject to the notice and comment requirement.

Title II of the Unfunded Mandates Reform Act (UMRA) of 1995, 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 by state, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted.

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

EPA has determined that this action contains no Federal mandates (under the regulatory provisions of title II of the UMRA) for State, local, or tribal governments or the private sector. This action imposes no enforceable duty on any State, local or tribal governments or the private sector. Thus, this action is not subject to the requirements of sections 202 and 205 of the UMRA.

EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. This rule only extends the stay of certain provisions and does not impose any additional enforceable duty.

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 action 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. This action will not impose direct compliance costs on State or local governments, and will not preempt State law. Thus, Executive Order 13132 does not apply to this action.

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 action does not have tribal implications, as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action.

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This action is not subject to Executive Order 13045 because the equipment leak NSPS for SOCMI and petroleum refineries are based on technology performance.

This action is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

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

EPA is not proposing to make any changes to the regulatory requirements in the final equipment leak NSPS in this action, including requirements that involve technical standards. As a result, the NTTAA discussion set forth in the November 16, 2007, final rule remains valid. The requirements of NTTAA, therefore, do not apply to this action.

Executive Order 12898 (59 FR 7629, February 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.

EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, EPA has made such a good cause finding, including the reasons therefore, and established an effective date of June 2, 2008. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

The United States, which includes the Commonwealth of Puerto Rico, American Samoa, the U.S. Virgin Islands, Guam, and all other U.S. commonwealths, territories, or possessions, is a member of the International Commission for the Conservation of Atlantic Tunas (ICCAT) and the Inter-American Tropical Tuna Commission (IATTC). Under ATCA, the Secretary of Commerce is authorized to implement ICCAT recommendations, as necessary or appropriate. Likewise, the Tunas Convention Act authorizes rulemaking to carry out recommendations of the IATTC. The United States has implemented statistical document programs under the HMS ITP program regulations per recommendations of ICCAT, IATTC, and other regional fishery management organizations (RFMOs). This rule replaces the ICCAT bluefin tuna statistical document program with the initial implementation of the ICCAT BCD program recommended at the 2007 ICCAT annual meeting. Other objectives of the rule are to adjust the HMS ITP regulatory program, as informed by NMFS and industry experiences since the program was implemented, and to adopt the new definition of import contained in the Magnuson-Stevens Act. Lastly, the rule requires permitting of shark fin traders under the HMS international trade regulations to help NMFS monitor trade of shark fins.

Background information about the need for the final rule was provided in the preamble to the proposed rule (73 FR 18473, April 4, 2008) and is not repeated here.

A description of the alternatives for the actions in this final rule was included in the preamble of the proposed rule, and is not repeated here. Other than minor technical corrections, this final rule does not include any changes from the proposed rule. Additional information can be found in the RIR/FRFA available from NMFS (see ADDRESSES).

Five public hearings were announced in the proposed rule (73 FR 18473, April 4, 2008) and held during the public comment period, which ended on May 5, 2008. The public hearings were held in the following locations: Santa Rosa, CA (April 23, 2008), Long Beach, CA (April 24, 2008), Gloucester, MA (April 25, 2008), Miami, FL (April 28, 2008) and Panama City, FL (April 29, 2008). In addition, the HMS Advisory Panel was briefed about the proposed rule on April 16, 2008. The agency received five written comments and many verbal comments at the public hearings and Advisory Panel meeting. A summary of public comments, followed by NMFS' responses to each comment, is provided below.

Comment 1: Several commentors stated that shark fin traders could provide valuable information and should be required to report.

Response: The final rule requires permitting for shark fin traders without additional reporting requirements at this time. NMFS considered additional reporting requirements for shark fin traders beyond the reporting already required by other state and/or Federal agencies, but determined that permit requirements alone would be an effective initial step in achieving the rule's objective to further understand the international trade aspects of the industry. The Agency may consider additional reporting requirements at a later date, with due notice and opportunity for public comment.

Comment 2: One commenter stated that U.S. bluefin tuna re-exporters are assigned an unfair reporting burden for re-export of untagged bluefin tuna relative to the bluefin tuna trade industry in other nations. The United States is one of the few countries that tags every exported fish, which results in a reduced burden for re-exporters in other nations. The U.S. industry carries more reporting burden than industry members in other countries.

Response: The final rule requires that re-exporters of untagged bluefin tuna provide copies of completed re-export certificates and associated documentation to the ICCAT Secretariat and competent authorities of importing nations at provided addresses. NMFS included this requirement since ICCAT Recommendation 07-10 specifically requires all nations, including the United States, to conduct such reporting. However, the United States' sophisticated catch monitoring program, which includes tagging every Atlantic bluefin tuna domestically and commercially harvested, exempts U.S. industry members from certain other parts of the ICCAT Recommendation 07-10 BCD program. NMFS will continue to work with ICCAT to balance the burden of international fisheries management fairly among participating nations. Overall, the reporting requirements of the ICCAT BCD program that must be implemented by the United States have been mitigated and reduced because of the U.S. programs currently in place.

Comment 3: A commentor stated that the proposed rule and regulatory program are complex, and the public comment period should be extended and more public hearings should be held on the east coast.

Response: NMFS did not extend the public comment period for this rulemaking or add public hearings to those announced with the proposed rule. NMFS worked to balance its obligations of meeting the international implementation deadline for the ICCAT BCD program while also conducting extensive public outreach with email, direct mail, and public hearings on both the Atlantic and Pacific coasts. NMFS undertook mailings to current permit holders and shark fin importers, and held public hearings in five locations that were chosen based on industry participation during the previous ITP rulemaking (69 FR 67268, November 17, 2004). The Atlantic HMS Advisory Panel was briefed on April 16, 2008. Further, documentation associated with this rulemaking was available on NMFS websites and www.regulations.gov. ICCAT adopted the BCD recommendation at the end of November 2007 and required its implementation by July 1, 2008. U.S. businesses desiring to export bluefin tuna to foreign markets could be negatively impacted if the BCD program was not in place by the required implementation date.

Comment 4: One ITP holder asked what type of document would be necessary for bluefin tuna imports into the United States originating from South Africa.

Response: The type of documentation required would depend upon the species of bluefin tuna traded. Southern bluefin tuna are found through the Southern Ocean, south of 30? South latitude. The final rule requires that an ICCAT BCD accompany any shipment of Atlantic bluefin tuna into the United States. The Commission for the Conservation of Southern Bluefin Tuna's statistical document continues to be required for imports of southern bluefin tuna into the United States.

Comment 5: One commentor noted that there are “transfer houses” in Boston that receive product from Canadian importers, but do not appear to be required to report any information to NMFS. One permit holder stated that they had experienced a greater degree of enforcement attention from NMFS. Several permit holders requested that the “playing field between businesses be level” regarding reporting burden and enforcement activity. One of these permit holders stated that NMFS enforcement personnel may pay more attention to their company because of its large size.

Response: The final rule maintains the previous requirement that the importer, which is defined as the consignee as listed on entry documentation required by Customs and Border Protection, must hold an ITP and abide by reporting requirements. If a non-resident corporation is listed as the consignee, then a resident agent is required to hold the permit and fulfill reporting requirements. All permit holders are equally responsible for abiding by applicable regulations. The NOAA Fisheries Office of Law Enforcement (OLE) investigates violations of the regulations promulgated by NOAA, based on the individual facts and circumstances of each case.

Comment 6: Several ITP holders expressed concern that they would be held responsible for imports from other countries that appeared to be legal, but were later determined to be illegal, unregulated, unreported (IUU) product, or product that came with falsified statistical documents that appeared to be legal upon import.

Response: HMS ITP holders are responsible for the reporting requirements and administrative recordkeeping articulated in the ITP regulations. Violations of the regulations promulgated by NOAA, including instances of ITP dealer non-compliance, will be examined by OLE on a case-by-case basis, based on the individual facts and circumstances of each case.

Comment 7: One commentor requested that there be internationally agreed upon methods for numbering consignment documents and for format of documents to assist importers in identifying illegal product.

Response: ICCAT Recommendation 07-10 requires that each BCD have a unique document identification number specific to the flag state. A circular from ICCAT (Circular #569/08) dated April 14, 2008, recommended a numbering convention for BCDs that would use 8 digits which include the country code and year of capture, followed by a unique, sequentially assigned number. The final rule states at § 300.186(b): “A nationally approved form from another country may be used for exports to the United States if that document strictly conforms to the information requirements and format of the applicable RFMO.”

Comment 8: Several permit holders stated that they were supportive of the increasing international role the United States is taking in reducing IUU fishing.

Response: One of the purposes of ICCAT's BCD program is to more accurately account for stock landings and help reduce IUU fishing. In addition, the Magnuson-Stevens Act includes several provisions to reduce IUU fishing. NMFS published an advance notice of proposed rulemaking on June 11, 2007 (72 FR 32052) and is currently drafting a proposed rule to implement these provisions.

Comment 9: Current ITP holders commented on several operational aspects of the trade monitoring program which were not addressed in this rulemaking, in reference to swordfish imports. The issues raised included the following: 1) most swordfish import statistical documents are received by fax rather than original documents, and some arrive three days after the consignment has been accepted in the United States; 2) because of the amount of swordfish imported into the United States, the trade monitoring requirements as written for swordfish are overly burdensome; and 3) flexibility is needed in the format of biweekly report forms. In addition, several comments were provided on shark and shark fin fishery management.

Response: These issues are outside the scope of this rulemaking and amendment to the ITP regulations. However, the current ITP regulations require that imports of swordfish, bluefin tuna, southern bluefin tuna, and frozen bigeye tuna be accompanied by original statistical documents which are provided to NMFS if the United States is the final point of import. Biweekly reports are required to be submitted to NMFS on forms provided by NMFS. NMFS may consider future modifications of the HMS ITP regulations, including further consideration of these comments. NMFS is in the process of coordinating with Customs and Border Protection to implement the International Trade Data System which is expected to modify NMFS import and trade-monitoring programs. An advanced notice of proposed rulemaking on this issue is expected to be published in the Federal Register during 2008.

The NMFS Assistant Administrator (AA) has determined that this final rule is consistent with the Consolidated HMS FMP, the Magnuson-Stevens Act, the ATCA, the TCA, and other applicable law. The AA has determined that this final rule is necessary to implement the recommendations of ICCAT and IATTC, and is necessary for the management of bluefin tuna, bigeye tuna, swordfish, and sharks.

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

A final regulatory flexibility analysis (FRFA) was prepared. The FRFA incorporates the initial regulatory flexibility analysis, a summary of the significant issues raised by the public, and NMFS responses to those comments. The FRFA describes the economic impacts this final rule could have on small entities. A description of the action, why it is being considered, and the legal basis for this action are contained at the beginning of the preamble and the SUMMARY section of the preamble. A summary of the analysis follows. A copy of this analysis is available from NMFS (see ADDRESSES).

The actions in this final rule could affect approximately 406 Atlantic Tunas Dealer Permit (ATDP) holders, 230 HMS ITP holders, and approximately 100 individuals who participate in international trade of shark fins, all of which are considered small entities. According to the RFA, a wholesale fish business is defined as a small entity if it employs 100 or fewer. Impacts to these entities could occur in two areas - permitting and reporting. NMFS expects only minor negative economic impacts from the final rule because the final measures only involve adjusting the permitting and reporting requirements. A description of the alternatives, associated requirements, and estimated costs follows.

The issues addressed in the final rule are subdivided into three categories: “permitting,” “reporting” and “regulatory structure and clarification.” Only two of the issues under the category of “permitting” include alternatives that could have economic impacts. For the issue of identification of the entity responsible for obtaining the HMS ITP in importing situations, and thus for fulfilling subsequent reporting requirements, the “No Action” alternative is the final action. The final rule continues to require the consignee as indicated in CBP import documentation to be the responsible party for obtaining the ITP. This alternative was chosen to for enforcement purposes since the consignee would be the actual receiver of the consignment, and would have an address within the United States. The annual costs associated with this action are the costs associated with permitting (including the cost of the permit, mailing costs and time for filling out the application - estimated at $26.75 per applicant) and the cost of reporting (including filling out and submitting the report forms - estimated at $102 per dealer for biweekly reports and $94 per dealer for trade tracking documentation, for a total of $196 per dealer). Alternative Two would require that the consignee on the bill of lading obtain an HMS ITP in addition to the consignee on CBP entry documentation, and was not chosen because it would have resulted in duplicative reporting. The overall negative economic impact for this alternative would increase based on the number of consignees identified on import bills of lading that differ from consignees on CBP documentation. NMFS estimates the cost of this alternative to be twice that of the final action, assuming that there is one additional permit holder for each current permit holder. Costs per dealer would be the same as for the final action. For Alternative Three, which would require the importer of record to obtain the HMS ITP, economic impacts are estimated to be approximately the same as the final action, using the assumption that there would be approximately the same number of importers of record identified on CBP entry documentation as consignees for consignments of products addressed under HMS ITP regulations. This alternative was not selected because importers of record can be foreign-based companies, which could impede enforcement.

The second permitting issue with alternatives that could have economic impacts is shark fin trader permitting. The final action requires that shark fin traders obtain an HMS ITP. This alternative was chosen to obtain information on the shark fin trade industry and support regulatory enforcement. NMFS anticipates that approximately 100 entities are expected to require the HMS ITP for shark fin trading. Since there would be no reporting requirements associated with this permit, the only annual costs are for obtaining the permit ($26.75 per dealer). The other alternative considered for this issue was the “No Action” Alternative, with neither permitting nor reporting costs for shark traders. This alternative was not selected because it would not provide the information needed on shark fin trading or support regulatory enforcement.

The second category of issues addressed in the final rule is under the heading of “Reporting.” None of the alternatives for these issues would change the number of entities required to obtain an HMS ITP, so there would be no permitting-related costs for any of these issues.

The first issue under the category of “Reporting” that has reporting-associated economic impacts includes alternatives that would adjust reporting requirements for when and how report submission would be required. Alternative One is the “No Action” alternative, and would not change any reporting regulations or associated annual costs, which are estimated at $196 per dealer. This alternative was not chosen because the current use of a postmark does not ensure that NMFS has received the report in a timely fashion. Alternative Two would rescind the requirement for copies of import statistical documents to be faxed to NMFS within 24 hours of receipt by an importer. This alternative was not selected because NMFS requires the opportunity to review import statistical documents as close to the time of import as possible. The regulation requiring the permit holder to fax the document to NMFS within 24 hours balances the need for NMFS to be promptly notified of the import with providing the permit holder a reasonable amount of time to complete the document.

This alternative would provide a slightly positive economic benefit in the form of a slightly reduced time burden for import reporting. Dealers would still be required to fill out and mail import statistical documents twice per month. The final action (Alternative 3) would adjust HMS ITP and ATDP reporting regulations to use a “received-by” date rather than a postmark date for determining dealer compliance with required report submittal schedules. The ITP regulations would also be clarified to indicate when use of a fax machine would be an acceptable method for submitting a report. This alternative was chosen because it establishes consistency within HMS regulations by using the “received-by” date to ensure NMFS receives the report by a date certain, and provides for all report submission alternatives, including faxes. It also retains the 24-hour reporting requirement for enforcement purposes. This alternative is expected to have no economic consequences, since it would not impact reporting frequency.

The second reporting-related issue considers alternatives to initially implement ICCAT Recommendation 07-10 and the new BCD program. The final action implements the program for commercial U.S. Atlantic bluefin tuna fisheries and bluefin tuna imports, exports and re-exports as part of a program that will apply to all ICCAT member nations. This alternative was chosen to keep the United States in compliance with the ICCAT Recommendation, and ensure that U.S. product would be accepted for import by other ICCAT member nations. The BCD program requires the use of new forms with fields similar to the ICCAT bluefin tuna statistical document that was in place before the BCD program was implemented. The change in reporting burden will only affect HMS ITP holders that re-export untagged bluefin tuna. When re-exporting an untagged bluefin tuna, the HMS ITP holder is required to send a copy of the re-export certificate to the ICCAT Secretariat and importing nation within five working days via addresses and information provided by NMFS. The costs per transaction could range from zero for electronic transmission of the documents, to approximately $100 for mailing, for an average of $50 per transaction. In 2006, 17 consignments would have been subject to this additional cost. In addition, a time burden of .25 hours per consignment would have resulted in an additional 4.25 aggregate hours for a total annual cost of $64, or $3.75 per transaction. There would be no additional costs for the No Action alternative, with current annual average costs for statistical document program reporting at $196 per dealer. The No Action alternative was not selected because it would result in the United States being out of compliance with ICCAT recommendations, and would hinder export of U.S. product to ICCAT member nations.

The last issue under this category addresses reporting of Atlantic bluefin tuna exports. The final action provides a positive economic impact, reducing the current reporting burden for individuals who hold both an ATDP and HMS ITP by clarifying that bluefin tuna exports would only need to be reported on one biweekly report. This alternative was chosen because it ensures the reporting burden for export of domestically landed Atlantic bluefin tuna is not duplicative with landing reporting requirements. This action could positively affect the 64 individuals who concurrently hold an ATDP and HMS ITP and could save an estimated $51 per dealer per year. In addition, the final action could reduce the reporting burden for HMS ITP holders who purchase bluefin tuna from an ATDP holder, with an estimated savings similar to those for individuals holding both permits. Alternative One, the “No Action” alternative, would continue to require reporting for both permits, and is estimated to cost each impacted dealer approximately $102 per year. Alternative Two would require that operational procedures were adjusted to mirror the current regulations. Neither of these alternatives were selected because each had a higher overall reporting burden than the final action. The economic impact of Alternative Two would be the same as that estimated for the “No Action” alternative.

The last category of issues addressed in the final rule is “Regulatory Structure and Clarification,” and includes two issues that could have economic consequences. The first issue is the implementation of the new definition of “import” included in the Magnuson-Stevens Act as amended by the Magnuson-Stevens Reauthorization Act. Both the “No Action” Alternative and the final action would have the same economic consequences, which would be the permitting and reporting costs associated with the current HMS ITP program, averaged at $222.75 per dealer per year. The final action was selected because it is consistent with the Magnuson-Stevens Act, and continues to clearly articulate the applicability of HMS ITP program regulations to shipments between the United States and its insular possessions. The “No Action” Alternative was not selected because it is not consistent with the Magnuson-Stevens Act. The second alternative would adopt the Magnuson-Stevens Act definition of “import,” without distinguishing that consignments between the United States and its insular possessions with separate customs territories would be considered domestic interactions, as intended by RFMO consignment programs. This alternative was not selected because it would unnecessarily increase reporting burdens. If such consignments required permitting and reporting under the HMS ITP program, negative economic consequences would occur which are currently unknown but, based in part on the amount of product and number of participating dealers, are expected to be minor in nature. For example, an average of four consignments from Guam to ports under U.S. Customs authority have occurred each year from 2002 through 2007. The estimated annual impact per dealer (approximately four dealers) would be $223.

The last issue considered in this final rule that could have economic impacts addresses the verification of foreign validating officials for imports. The final rule includes no regulatory changes for this issue. Under the Preferred Alternative, NMFS would pursue further international coordination on this issue, and there would be no economic related consequences. This alternative was selected to mitigate reporting burden for U.S. businesses and further coordinate international action for this issue. Likewise, the “No Action” Alternative would not have economic consequences since it does not require any current or additional action. This alternative was not selected because it would not provide a way to verify validating authorities. Alternative Two could have considerable negative economic consequences since it would require that importers check the password-protected ICCAT website to determine whether validating officials are authorized government representatives. This alternative would require computer hardware and software with Internet access. Alternative Two was not selected because it is unclear whether it is consistent with the intent of the ICCAT statistical document program.

Fishermen, fish dealer permit holders, and fishery managers involved in these fisheries must comply with a number of international agreements, domestic laws, regulations and FMPs. These include, but are not limited to, ICCAT, the Magnuson-Stevens Act, ATCA, the High Seas Fishing Compliance Act, the Marine Mammal Protection Act, the Endangered Species Act, the National Environmental Policy Act, the Paperwork Reduction Act, and the Coastal Zone Management Act. NMFS strives to ensure consistency among the regulations with Regional Fishery Management Councils and other relevant agencies. NMFS does not believe that the final rule would conflict with any relevant regulations, federal or other.

One of the requirements of FRFA is to describe any alternatives to the proposed rule which accomplish the stated objectives and which minimize any significant economic impacts. Economic impacts are discussed above and below. Additionally, the RFA Section 603(c)(1)-(4)) lists four categories of options which should be discussed. These categories are: (1) establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) use of performance rather than design standards; and (4) exemptions from coverage of the rule for small entities.

Under the first and fourth categories listed above, NMFS considers all dealers to be “small entities.” Thus, in order to meet the objectives of this final rule and address management concerns, NMFS cannot exempt small entities or change the reporting requirements for small entities.

Category Two includes options for clarifying, simplifying, and consolidating compliance and reporting requirements for small entities. Many of the measures in this final rule satisfy the goal of Category Two by simplifying or clarifying the existing dealer permitting or reporting structure in several instances, and by seeking further international clarity for several issues that cannot be implemented under the current program. Specifically, the final rule clarifies who is the entity responsible for obtaining the HMS ITP in cases involving foreign importers and would synchronize requirements between HMS ITPs and NMFS regional permits. Although alternatives are considered for modifying the entity responsible for obtaining a permit based on CBP entry documentation, the final rule does not modify the current regulations, which is the simplest of the alternatives considered.

The final rule reduces and simplifies reporting requirements so that reporting may be combined in certain instances when an individual holds both the HMS ITP and the ATDP, which have similar reporting requirements. A dealer holding one of these permits can also coordinate with a dealer who handles the same individual bluefin tuna but holds the other corresponding permit. The final rule also clarifies the use of faxes for report submission and would further consistency with other HMS regulations by establishing the “received by” date as the date used for compliance determinations. There would be some increase in reporting burden and cost because of the requirement for international communication of consignment documents directly to the ICCAT secretariat and importing nation's government agency, however costs should be minimized since affected businesses are encouraged to submit the required documentation electronically.

The final rule also directly addresses issues of regulatory structure and clarification. The final rule updates certain HTS codes and serves in part to clarify reporting. The final rule also adopts the Magnuson-Stevens Act definition of import, with a clarifying caveat that consignments of affected product between insular possessions and the United States are not considered imports. Finally, the final rule clarifies that the regulatory requirements in 50 CFR part 300 subpart M apply to all entities engaging in covered activities, rather than just those who obtain the required permit. Alternatives for verification of validating authorities are also considered, but because of technical difficulties, no action requiring verification of validation is included in the final rule.

The third category identified in the RFA, “use of performance rather than design standards,” is not applicable, since ICCAT has very specific requirements for implementation of the trade tracking programs addressed in this action. Although the shark fin trade is not currently covered by an ICCAT recommendation, in order to address Category Two and maintain a simple structure for HMS trade permits, shark fin traders are required to obtain an HMS ITP under the final rule.

This final rule contains revisions to collection-of-information requirements subject to the Paperwork Reduction Act which have been previously approved by OMB under the HMS Permitting Family of Forms (0648-0327) and the HMS Dealer Reporting Family of Forms (0648-0040). In the HMS Permitting Family of Forms, the instrument being revised is the application for the HMS ITP for Atlantic coast dealers that import, export, or re-export bluefin tuna, southern bluefin tuna, frozen bigeye tuna, and swordfish, the public reporting burden for which is estimated at 0.08 hours (5 minutes) per response. In the HMS Dealer Reporting Family of Forms, the instruments being revised are the bluefin tuna statistical document and re-export certificate, the public reporting burden for which is estimated at .08 hours (5 minutes) per form. The statistical document will be replaced by a catch document with an equivalent reporting burden. The reporting burden for re-exports of untagged bluefin tuna is estimated to be an additional .25 hours (15 minutes) per form. These estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Send comments regarding these burden estimates or any other aspect of this data collection, including suggestions for reducing the burden to NMFS (see ADDRESSES) and by email to David_Rostker@omb.eop.gov, or fax to (202) 395-7285.

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number.

Administrative practice and procedure, Exports, Fish, Fisheries, Fishing, Imports, Reporting and recordkeeping requirements, Treaties.

Fisheries, Fishing, Fishing vessels, Imports, Reporting and recordkeeping requirements, Treaties.