The Popcorn Promotion, Research, and Consumer Information Act of 1996 (Act) (7 U.S.C. 7481 et seq. ) authorized the Popcorn Promotion, Research, and Consumer Information Order (Order) which is industry operated and funded, with oversight by USDA. The Order's objective is to carry out an effective and continuous coordinated program of research, development, advertising, and promotion designed to strengthen popcorns' competitive position, and to maintain and expand domestic and foreign markets for popcorn and popcorn products.

The Order (7 CFR Part 1215) became effective on September 1, 1997, and was implemented in January 1998 when assessments began. The Popcorn Board (Board) collects assessments from processors of over four million pounds of popcorn per year, regardless of the country of origin of the popcorn. The assessment rate is 6 cents per hundredweight.

Assessments under this program are used to fund promotional campaigns and to conduct research in the areas of U.S. marketing, and international marketing and to enable it to exercise its duties in accordance with the Order.

The Order is administered by the Popcorn Board, which is composed of nine at-large processors who were appointed by the Secretary of Agriculture from nominations submitted by eligible processors. All processors of over four million pounds of popcorn annually are eligible to participate in the nomination process. All Board members serve terms of three years.

The Agricultural Marketing Service published in the Federal Register on March 24, 2006 (71 FR 14828) its plan to review certain regulations, including the Order, (conducted under the Popcorn Promotion, Research, and Consumer Information Act), under criteria contained in Section 610 of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612). Because many AMS regulations impact small entities, AMS decided, as a matter of policy, to review certain regulations which, although they may not meet the threshold requirement under section 610 of the RFA, warranted review.

AMS published a notice of review and request for written comments in the Federal Register on February 27, 2007 (72 FR 8633). The comment period ended on April 30, 2007. AMS received two comments. One commenter stated that it is a waste of tax dollars for USDA to oversee this program. In addition, the commenter stated that there is nothing about popcorn that needs to be researched and that private industry should conduct research if they so choose.

Expenses under the program are covered by assessments paid by the industry. The Popcorn Board is comprised of industry members that decide the projects the Board will conduct every year. All the activities of the Board, including USDA oversight costs, are paid by the popcorn industry from the assessments collected. Accordingly, no changes will be made based on this comment.

The second commenter was in favor of the program, noting that it increases awareness of popcorn.

The review was undertaken to determine whether the Order should be continued without change, amended, or rescinded (consistent with the objectives of the Act) to minimize the impacts on small entities. In conducting this review, AMS considered the followings factors: (1) The continued need for the Order; (2) the nature of complaints or comments received from the public concerning the Order; (3) the complexity of the Order; (4) the extent to which the Order overlaps, duplicates, or conflicts with other Federal rules, and, to the extent feasible, with State and local regulations; and (5) the length of time since the Order has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the Order.

Currently, there are approximately 35 processors who are subject to the provisions of the Order. Processors of less than four million pounds of popcorn are exempt from assessment.

AMS provides Federal oversight of the Popcorn program. The Order is not unduly complex, and AMS has not identified any Federal rules, or State and local regulations that duplicate, overlap, or conflict with the Order. Over the years, regulation changes have been made to address industry operation changes and to improve program administration. The goal of these evaluations is to assure that the Order and the regulations implemented under it fit the needs of the industry and are consistent with the Act.

Based upon its review, AMS has determined that the Order should be continued without change. AMS plans to continue working with the popcorn industry in maintaining an effective program.

Regulatory Information

On April 11, 2007, we published a notice of proposed rulemaking (NPRM) entitled Special Local Regulations for Marine Events; Rappahannock River, Essex County, Westmoreland County, Layton, VA in the Federal Register (72 FR 18170). We received no letters commenting on the proposed rule. No public meeting was requested, and none was held.

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 . Delaying the effective date would be contrary to the public interest, since immediate action is needed to ensure the safety of the event participants, spectator craft and other vessels transiting the event area. However, advance notifications will be made to affected waterway users via marine information broadcasts, local radio stations and area newspapers.

On June 30, 2007 the Rappahannock River Boaters Association (RRBA) will sponsor the “2007 RRBA Spring Radar Shootout”, on the waters of the Rappahannock River near Layton, Virginia. The event will consist of approximately 35 powerboats participating in high-speed competitive races, traveling along a 3-mile straight line race course. Participating boats will race individually within the designated 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 participants, spectators and transiting vessels.

The Coast Guard did not receive comments in response to the notice of proposed rulemaking (NPRM) published in the Federal Register . Accordingly, the Coast Guard is establishing temporary special local regulations on specified waters of the Rappahannock River, near Layton, Virginia.

This temporary 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.

Although this regulation will prevent traffic from transiting a portion of the Rappahannock 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 notification that will be made to the maritime community via the Local Notice to Mariners, marine information broadcasts, local radio stations and area newspapers, so mariners can adjust their plans accordingly. Additionally, the regulated area has been narrowly tailored to impose the least impact on general navigation yet provide the level of safety deemed necessary. Vessel traffic will be able to transit the regulated area between heats, when the Coast Guard Patrol Commander deems it is safe to do so.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this temporary 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 temporary rule would not have a significant economic impact on a substantial number of small entities. This temporary rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit this section of the Rappahannock River during the event.

This temporary rule will not have a significant economic impact on a substantial number of small entities for the following reasons. This temporary rule will be in effect for only a short period, from 11:30 a.m. to 4:30 p.m. on June 30, 2007. Although the regulated area will apply to a 3-mile segment of the Rappahannock River immediately east of Layton, Virginia, traffic may be allowed to pass through the regulated area with the permission of the Coast Guard patrol commander. Before the enforcement period, we will 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 offered to assist small entities in understanding this temporary rule so that they can better evaluate its effects on them and participate in the rulemaking.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast 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 temporary rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this temporary 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 temporary rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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

This temporary rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this temporary 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 temporary rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this temporary rule under Commandant Instruction M16475.lD and Department of Homeland Security Management Directive 5100.1, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(h), of the Instruction, from further environmental documentation.

Under figure 2-1, paragraph (34)(h), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule.

On May 4 2007, we published a notice of proposed rulemaking (NPRM) entitled Safety Zone, Chicago Harbor, Navy Pier Southeast, Chicago, IL. in the Federal Register (72 FR 25217). We received no letters commenting on the proposed rule. No public meeting was requested, and none was held.

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 . Any delay encountered in the regulation's effective date would be contrary to the public interest since the safety zone is needed to prevent traffic from transiting a portion of Chicago Harbor during fireworks displays, thus ensuring that the maritime public is protected from any potential harm associated with such an event.

This safety zone is necessary to protect vessels and people from the hazards associated with fireworks displays. Such hazards include the explosive danger of fireworks and debris falling into the water that may cause death or serious bodily harm.

No comments were received concerning this final rule. No changes were made.

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.

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.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could 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 affect 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.

The Coast Guard recognizes the treaty rights of Native American Tribes. Moreover, the Coast Guard is committed to working with Tribal Governments to implement local policies and to mitigate tribal concerns. We have determined that this safety zone and fishing rights protection need not be incompatible. We have also determined that 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. Nevertheless, Indian Tribes that have questions concerning the provisions of this Proposed Rule or options for compliance are encouraged to contact the point of contact listed under FOR FURTHER INFORMATION CONTACT .

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)(g), of the Instruction, from further environmental documentation. This rule establishes a safety zone area and as such is covered by this paragraph.

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

Regulatory Information

On May 4, 2007, we published a notice of proposed rulemaking (NPRM) entitled Safety Zone, Milwaukee Harbor, Milwaukee, WI in the Federal Register (72 FR 25226). We received no letters commenting on the proposed rule. No public meeting was requested, and none was held.

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 . Any delay encountered in the regulation's effective date would be contrary to the public interest since the safety zone is needed to prevent traffic from transiting a portion of Milwaukee Harbor during fireworks displays, thus ensuring that the maritime public is protected from any potential harm associated with such an event.

There are approximately twenty fireworks displays launched annually at Lakeshore State Park in Milwaukee, WI. The fireworks displays are sponsored festivals located at Henry W. Maier Festival Park. The fireworks displays impact the navigable waters of Milwaukee Harbor and pose a hazard to vessels and people. This rule establishes a limited access area around the fireworks launch site to protect vessels and people from the hazards associated with fireworks displays. Such hazards include the explosive danger of fireworks and debris falling into the water that may cause death or serious bodily harm.

No comments were received concerning this final rule. However, the published Notice of Proposed Rule Making contained an error concerning the coordinates for this safety zone. The northeast coordinate of the safety zone was incorrect and has been changed to 43°02′00″ N, 087°53′25″ W. No other changes have been made.

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.

We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation is unnecessary.

The Coast Guard's use of this safety zone will be periodic in nature and will likely not exceed twenty, three-hour events, per year. This safety zone has been designed to allow vessels to transit unrestricted to portions of the harbor not affected by the zone. The Coast Guard expects insignificant adverse impact to mariners from the activation of this zone.

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.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could 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 affect 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.

The Coast Guard recognizes the treaty rights of Native American Tribes. Moreover, the Coast Guard is committed to working with Tribal Governments to implement local policies and to mitigate tribal concerns. We have determined that this safety zone and fishing rights protection need not be incompatible. We have also determined that 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. Nevertheless, Indian Tribes that have questions concerning the provisions of this rule or options for compliance are encouraged to contact the point of contact listed under FOR FURTHER INFORMATION CONTACT .

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)(g), of the Instruction, from further environmental documentation. This rule establishes a safety zone and as such is covered by this paragraph.

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

Regulatory Information

On May 7, 2007, we published a notice of proposed rulemaking (NPRM) entitled Safety Zone, Chicago Harbor, Navy Pier East, Chicago, IL. in the Federal Register (72 FR 25720). We received no letters commenting on the rule. No public meeting was requested, and none was held.

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 . Any delay encountered in the regulation's effective date would be contrary to the public interest since the safety zone is needed to prevent traffic from transiting a portion of Chicago Harbor during fireworks displays, thus ensuring that the maritime public is protected from any potential harm associated with such an event.

This safety zone is necessary to protect vessels and people from the hazards associated with fireworks displays. Such hazards include the explosive danger of fireworks and debris falling into the water that may cause death or serious bodily harm.

No comments were received concerning this final rule. No changes were made.

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.

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. The Coast Guard's use of this safety zone will be periodic in nature and will likely not exceed 10, one-hour events per year. This safety zone will only be enforced during the time the safety zone is actually in use. Furthermore, this safety zone has been designed to allow vessels to transit unrestricted to portions of the harbor not affected by the zone. The Coast Guard expects insignificant adverse impact to mariners from the activation of this zone.

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.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could 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.

The Coast Guard recognizes the treaty rights of Native American Tribes. Moreover, the Coast Guard is committed to working with Tribal Governments to implement local policies and to mitigate tribal concerns. We have determined that this safety zone and fishing rights protection need not be incompatible. We have also determined that 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. Nevertheless, Indian Tribes that have questions concerning the provisions of this rule or options for compliance are encouraged to contact the point of contact listed under FOR FURTHER INFORMATION CONTACT .

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)(g), of the Instruction, from further environmental documentation. This rule establishes a safety zone and as such is covered by this paragraph.

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

Entities potentially affected by this final action include sources in all industry groups. The majority of sources potentially affected are expected to be in the following groups.

Entities potentially affected by this final action also include State, local, and tribal governments that are delegated authority to implement these regulations. This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. To determine whether your facility would be affected by this action, you should carefully examine the applicability criteria in parts 51 and 52 of title 40 of the Code of Federal Regulations.

On December 31, 2002, EPA published a final rule (67 FR 80186) which established CU and expanded upon provisions pertaining to PCP which were initially promulgated on July 21, 1992 (57 FR 32314). On June 24, 2005, the United States Court of Appeals for the District of Columbia Circuit (the Court) issued an opinion vacating those portions of the 2002 and 1992 rules that pertained to CU and PCP. New York v. EPA , 413 F.3d 3 (D.C. Cir.), reh'g. and reh'g. en banc den. 431 F.3d 801 (2005).

This action removes from the Code of Federal Regulations (CFR) all provisions for CU and PCP containing the provisions vacated by the Court. It should be noted that nearly identical CU and PCP provisions are found in 40 CFR 52.21, 51.165, and 51.166, and that the Court's opinion specifically addressed the CU and PCP provisions in § 52.21, but not the provisions in §§ 51.165 and 51.166. Even so, the plain language of the Court's opinion clearly applies to the parallel constructions in those latter provisions; and as a result, today's action removes those provisions as well. Because the Court vacated the language of the CU and PCP provisions as well as the legal constructs upon which they were based, the EPA is rescinding the CU and PCP provisions by way of a final rulemaking which is effective upon publication in the Federal Register . We are not providing an opportunity for comment.

The Administrative Procedure Act of 1946 (APA) makes provision for the procedural path we are following in this action. In general, the APA requires that general notice of proposed rulemaking shall be published in the Federal Register . Such notice must provide an opportunity for public participation in the rulemaking process. The APA does provide an avenue for an agency to directly issue a final rulemaking in certain specific instances. This may occur, in particular, when an agency for good cause finds (and incorporates the finding and a brief statement of reasons therefore in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest. See 5 U.S.C. 553(b)(3)(B).

In this action, the Agency finds that notice and comment is unnecessary. This action is ministerial in nature. It simply implements the decision of the D.C. Circuit as it pertains to CU and PCP.

In addition, notice and comment would be contrary to the public interest by unnecessarily delaying the removal of the unlawful CU and PCP provisions in the CFR. Owner/operators of facilities capable of causing air pollution are subject to CAA regulations governing the manner in which they might act. Substantial costs are frequently associated with project delays or inappropriate actions. To resolve regulatory concerns up front, those who would pursue projects which might be subject to Federal restrictions rely upon the CFR to provide authoritative answers as to what requirements apply to a given proposed project.

For the reasons cited above, EPA is making this action effective upon publication. See 5 U.S.C. 553(d)(3). This action removes content from the CFR that has been found to be contrary to the CAA by a Federal appeals court. This is a ministerial but necessary action on the part of the EPA. Given the substantial costs to owner/operators of projects associated with delays and uncertainty, EPA has good cause to act in the public interest to implement the court's remedy by amending the CFR without delay.

The Court's vacatur of PCP and CU provisions meant that these provisions could no longer be used. Thus, today's rule changes are immediately effective for jurisdictions using the Federal PSD program (codified at § 52.21 for areas without an approved PSD program, for which we are the reviewing authority, or for which we have delegated our authority to issue permits to a State or local reviewing authority) and for State and local agency programs implementing part C (PSD permit program in § 51.166) or part D (nonattainment NSR permit program in § 51.165) under an approved State Implementation Plan (SIP). Permitting authorities with approved SIPs containing any or all of the 2002 CU, 2002 PCP, or 1992 PCP provisions should remove those provisions as soon as feasible, which may be in conjunction with the next available SIP revision. Furthermore, recognizing that some States also adopted our past guidance policy on PCP  1 into their approved SIPs, we believe that these portions of their SIPs should also be removed in light of the Court decision. 2 Because of the Court decision, these provisions are unlawful and may not be applied even prior to their removal from the SIPs.

The Office of Management and Budget (OMB) determined this rule is a significant regulatory action for the purpose of EO 12866 and requested that we submit the rule for OMB review. It does not meet requirements for review under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). It also does not meet the requirements for review under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4), Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), Executive Order 13175, entitled Consultation and Coordination With Indian Tribal Governments (65 FR 67249, November 9, 2000), Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), or Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). In addition, this rule does not impose any impact on small entities and thus does not require preparation of a regulatory flexibility analysis under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .).

The deletion of CU and PCP provisions from NSR and PSD requirements will reduce the associated overall reporting and recordkeeping burden estimates, but this action does not require any review or approval by OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. At some point in the future, EPA will re-determine the total burden associated with the NSR and PSD rules and will adjust the estimates to reflect the effects of this action. The reporting and recordkeeping burdens associated with NSR and PSD are approved by OMB under OMB No. 2060-0003. The current public reporting burden for NSR and PSD is estimated to be 4,878,634 hours. These estimates include the time needed for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Pursuant to the Congressional Review Act, 5 U.S.C. 801 et seq ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, 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 . However, section 808 of that Act provides that any rule for which the issuing agency for good cause finds (and incorporates the finding and a brief statement of reasons therefore in the rule) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the agency promulgating the rule determines (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 13, 2007. This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

The statutory authority for this action is provided by sections 165-169, 171-173, and 301 of the Act as amended (42 U.S.C. 7475-7479, 7501-7503, and 7601). This rulemaking is also subject to section 307(d) of the Act (42 U.S.C. 7407(d)).

Under section 307(b)(1) of the Act, judicial review of this final rule is available only by the filing of a petition for review in the U.S. Court of Appeals for the District of Columbia Circuit by August 13, 2007. Any such judicial review is limited to only those objections that are raised with reasonable specificity in timely comments. Under section 307(b)(2) of the Act, the requirements that are the subject of this final rule may not be challenged later in civil or criminal proceedings brought by us to enforce these requirements.

Throughout this document, “we,” “us” and “our” refer to EPA.

On August 28, 2006 (71 FR 50875), EPA proposed approval and disapproval of portions of the State's rescission request and approval of certain replacement provisions. One of the rescission requests for which we proposed approval involved a Federal implementation plan (FIP) that we promulgated in the 1970's at 40 CFR 52.1475(c), (d), and (e) to regulate sulfur oxides from the Kennecott Copper Company smelter located in White Pine County, Nevada. As described further in our Technical Support Document (TSD) for the proposed rule, we found that the last vestige of the Kennecott Copper Company McGill facility, which was the subject of the FIP requirements in 52.1475, was removed from the area in 1993, and, therefore, the related FIP provisions are obsolete. The TSD contains more information about our proposed action. On January 3, 2007 (72 FR 11), we took final action on most of the provisions for which we had proposed action on August 28, 2006. This is the second final action related to our August 28, 2006 proposal. We will take final action on the remaining few provisions for which we proposed action on August 28, 2006 in a third separate action.

EPA's proposed action provided a 30-day public comment period. During this period, we received no comments related to the proposed rescission of the FIP for regulation of the Kennecott Copper Company smelter in White Pine County, Nevada.

As authorized in section 110(k)(3) of the Clean Air Act, EPA is finalizing the approval of the rescission of the Federal implementation plan promulgated for the regulation of fugitive sulfur oxides emissions from the Kennecott Copper Company smelter that had operated in White Pine County, Nevada, but that is no longer in existence. EPA is codifying this action by revising 40 CFR 52.1475 to remove paragraphs (c), (d), and (e).

The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order 12866, entitled “Regulatory Planning and Review.” This action will rescind a Federally promulgated rule for an air pollution emissions source that no longer exists.

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. This action will merely rescind a Federally promulgated rule for an air pollution emissions source that no longer exists.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

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

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

After considering the economic impacts of today's final rule on small entities, I certify that this rule will not have a significant impact on a substantial number of small entities because this rule merely rescinds a Federally promulgated rule for an air pollution emissions source that no longer exists.

Under sections 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a Federal mandate that may result in estimated costs to State, local, or tribal governments in the aggregate; or to the private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that this final rule does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action rescinds a Federally promulgated rule for an air pollution emissions source that no longer exists, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action. EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments.

Federalism (64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612 (Federalism) and 12875 (Enhancing the Intergovernmental Partnership). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

This rule 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, because it merely rescinds a Federally promulgated rule for an air pollution emissions source that no longer exists, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

Executive Order 13175, entitled (Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This final rule does not have tribal implications, as specified in Executive Order 13175. 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. Thus, Executive Order 13175 does not apply to this rule.

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

This rule 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 finalizes the rescission of a federally promulgated rule.

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

Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use (voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.

The EPA believes that VCS are inapplicable to this action. Today's action does not require the public to perform activities conducive to the use of VCS.

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. Because this rule amendment rescinds a federal implementation plan for a source that has closed down, this rule amendment that does not relax the control measures on sources regulated by the rule and therefore will not cause emissions increases from these sources.

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 July 13, 2007.

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 13, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

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

Comment: EPA received one comment on its January 25, 2007 proposal. The American Composites Manufacturers Association (ACMA) stated that it agreed with EPA that the VOC emissions from these facilities are subject under the NESHAPS to enforceable emission reductions, and added that an additional requirement to comply with the SIP VOC rules would place a redundant and unnecessary administrative burden on both the facilities and Indiana. ACMA referenced a study conducted for it in 2003 that concluded that a facility that meets the NESHAPS requirements would also comply with VOC SIP requirements, including lowest achievable emission rate (LAER), BACT and reasonably available control technology (RACT). ACMA strongly supports EPA's approval of this proposed amendment to the Indiana SIP.

EPA response: Although ACMA stated its strong support for EPA approval of this exemption for new sources subject to the boat manufacturing and reinforced plastic composites production NESHAPS, it claimed that a facility meeting the NESHAPS requirements would also meet LAER, BACT and RACT. LAER is the new source control requirement for nonattainment areas, as required by 326 IAC 2-3 (Nonattainment New Source Review). Best available control technology, in the context of ACMA's comment, appears to refer to the new source control requirement for attainment areas, as required by 326 IAC 2-2 (Prevention of Significant Deterioration). (Please note that this is not the same BACT analysis performed by the State under SIP rule 326 IAC 8-1-6). RACT is the VOC control SIP requirement for existing sources in ozone nonattainment areas.

In contrast to NESHAPS requirements, LAER and BACT are the result of case-by-case analyses which, as new and improved control technologies are introduced, tend to become more stringent over time. EPA has established a presumptive norm for RACT for a number of source categories, not including boat manufacturing and reinforced plastic composites production. For these other categories, RACT is a case-by-case analysis based upon the technical and economic feasibility of control, in contrast to the subject NESHAPS, which were based upon a set of industry average parameters.

EPA is approving Indiana's revision to its SIP consisting of an amendment to 326 IAC 8-1-6, new facilities; general reduction requirements. This rule exempts boat manufacturers subject to 326 IAC 20-48, NESHAPS for boat manufacturing, or reinforced plastics composites manufacturers subject to 326 IAC 20-56, NESHAPS for reinforced plastics composites production facilities, from the requirement to do a case-by-case State BACT analysis, for the purposes of 326 IAC 8-1-6, provided they comply with the applicable NESHAPS. Previously, new boat manufacturing or reinforced plastics composites manufacturing facilities with potential emissions of 25 tons or more per year of VOC were required to reduce VOC emissions by using BACT under 326 IAC 8-1-6. In this case, establishing specific standards in place of a case-by-case analysis improves the clarity, predictability, and timeliness of permit decisions that are currently subject to 326 IAC 8-1-6.

It should be noted, however, that approval of this exemption to 326 IAC 8-1-6 does not address (or take action on) whether the boat manufacturing or reinforced plastics composites production NESHAPS represent RACT, BACT (under PSD) or LAER (under Nonattainment New Source Review).

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and, therefore, is not subject to review by the Office of Management and Budget.

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

This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).

Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

This action also does not have Federalism implications because it does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act.

This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

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

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

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

Under Section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 13, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See Section 307(b)(2).)

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

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

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

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

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

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

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

Under section 408(g) of the FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0559 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before August 13, 2007.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2006-0559, by one of the following methods:

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

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

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

In the Federal Register of July 26, 2006 (71 FR 42390) (FRL-8079-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filings of a pesticide petitions (PP 2E6438, 6E3390 and 6F4680) by Interregional Research Project Number 4 (IR-4), 681 Highway 1 South, North Brunswick, NJ 08902 and the Catfish Farmers of America, 1100 Hwy. 82 East, Suite 202, Indianola, MS 38751. The petitions requested that 40 CFR 180.106 be amended by establishing tolerances for residues of the herbicide diuron (3-(3,4-dichlorophenyl)-1,1-dimethylurea in or on cactus, prickly pear at 0.05 part per million (ppm) (6E3390), mint at 1.5 ppm (2E6438) and freshwater finfish, farm raised at 2.0 ppm (6F4680). That notice referenced a summary of the petitions prepared by Dupont, the registrant, which is available to the public in the docket, http://www.regulations.gov . Comments received on the notice of filing are discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA has recommended certain changes to the petitions including:

1. Revised tolerance levels for certain commodities;

2. A revised tolerance expression to be applied to all new uses; and

3. Revised commodity terms for some commodities.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” These provisions were added to the FFDCA by the Food Quality Protection Act (FQPA) of 1996.

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerance for combined residues of diuron (3-(3,4-dichlorophenyl)-1,1-dimethylurea and its metabolites convertible to 3,4-dichloroaniline on cactus at 0.05 ppm, spearmint, tops at 1.5 ppm, peppermint, tops at 1.5 ppm and fish - freshwater finfish, farm raised at 2.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by diuron as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov . The referenced document is available in the docket established by this action, which is described under ADDRESSES , and is identified as EPA-HQ-OPP-2006-0059. Additional information regarding this chemical can also be found in the docket for the reregistration eligibility decision (RED) for diuron identified as EPA-HQ-OPP-2002-0249.

Diuron has low acute toxicity (Toxicity Category 3-4) by the oral, dermal, or inhalation exposure routes. Diuron is not an eye or skin irritant, and not a skin sensitizer. The primary target organs are the hematopoietic system, the bladder, and renal pelvis. Erythrocyte damage resulted in hemolytic anemia and compensatory hematopoiesis, which were manifested as significantly decreased erythrocyte counts, hemoglobin levels, and hematocrit, and increased mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), abnormal erythrocyte forms, reticulocyte counts, and leukocyte count. Consistent observations of erythrocytic regeneration were seen in chronic toxicity studies in rats, mice and dogs. Gross pathology findings in chronic rat and mouse studies showed increased incidences of urinary bladder edema and wall thickening at high doses. Microscopic evaluation showed dose-related increases in the severity of epithelial focal hyperplasia of the urinary bladder and renal pelvis in both sexes. The available data did not reveal any developmental or reproductive toxicity. The Carcinogenicity Peer Review Committee (CPRC) characterized diuron as a “known/likely” human carcinogen based on urinary bladder carcinomas in both sexes of the Wistar rat, kidney carcinomas in the male rat, and mammary gland carcinomas in the female NMRI mouse. Diuron was not mutagenic in bacteria or in cultured mammalian cells and no indication of DNA damage in primary rat hepatocytes was observed. There were marginal statistically significant increases in cells with structural aberrations in a Sprague Dawley rat in vivo bone marrow chromosomal aberration assay. However, the levels of aberrations were within historical control range and assessed negative.

The Metabolism Assessment Review Committee (MARC) recommended that a separate dietary cancer assessment be conducted for N'-(3-chlorophenyl)-N,N-dimethyl urea (MCPDMU), a potential residue of concern in drinking water, but not found in food (in plant or animal metabolism studies). The MARC raised concerns for MCPDMU based on an analogous compound, N'-(4-chlorophenyl)-N,N-dimethyl urea (monuron). With the exception of the position of the chlorine, the structures are identical. There are cancer concerns for monuron but the target organs are different than those affected by diuron. In the absence of the data needed for a more comprehensive evaluation of MCPDMU, the carcinogenic risk assessment was conducted using the Q 1 * of monuron.

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

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

A summary of the toxicological endpoints for diruon used for human risk assessment can be found at www.regulations.gov in document Diuron. Updated Aggregate Risk Assessment to Support Permanent Tolerances for Residues in Prickly Pear Cactus, Peppermint Tops, Spearmint Tops, and Freshwater Finfish, Farm-Raised at page 4 in Docket ID EPA-HQ-OPP-2006-0059.

There are no adverse effects attributed to a single exposure identified in any available studies for diuron. In addition, diuron has low acute toxicity and no developmental or neurotoxic concerns. Therefore, no acute dietary endpoint was chosen and no acute dietary risk assessment was conducted. Also, no systemic toxicity was observed following repeated dermal dosing up to 1,200 mg/kg/day. Therefore, no short- or intermediate-term dermal endpoints were chosen either. The short-term incidental oral and the inhalation endpoints are based on decreased maternal body weight and food consumption observed in a rabbit developmental toxicity study [No Observable Adverse Effect Level (NOAEL) = 10 mg/kg/day]. The intermediate-term incidental oral and intermediate-term inhalation endpoints are based on hematological effects observed at 10 mg/kg at 6 months in the chronic rat study. The NOAEL is 1 mg/kg/day. The chronic dietary, and long-term dermal and inhalation endpoints are based on hemolytic anemia and compensatory hematopoiesis [Lowest Observable Adverse Effect Level (LOAEL) = 1.0 mg/kg/day]. Since the dose and endpoint for establishing the chronic dietary reference Dose (RfD) is a LOAEL and a NOAEL was not established, a total uncertainty factor (UF) of 1,000 was applied (a UF of 100 to account for both interspecies extrapolation and intra-species variability and an UF of 10 since the 10X FQPA safety factor has been retained to protect infants and children). A low dose linear extrapolation model with a Q 1 * of 1.91 x 10 - 2 (mg/kg/day) - 1 was applied to the animal data for the quantification of human risk to diuron, based on the urinary bladder carcinomas in the rat.

As discussed in Unit III.A., a separate dietary cancer assessment was conducted for N'-(3-chlorophenyl)-N,N-dimethyl urea (MCPDMU), a potential residue of concern in drinking water, but not found in food. A low dose linear extrapolation model with a Q 1 * of 1.52 x 10 - 2 (mg/kg/day) - 1 was applied to the animal data for the quantification of human risk, based on male rat liver neoplastic nodule and/or carcinoma combined tumor rates.

1. Dietary exposure from food and feed uses . In evaluating dietary exposure to diuron, EPA considered exposure under the petitioned-for tolerances as well as all existing diuron tolerances in (40 CFR 180.106). EPA assessed dietary exposures from diuron and its metabolites convertible to 3,4-dichloroaniline in food as follows:

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

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

ii. Chronic exposure . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, the EPA analyses incorporated tolerance level residues for some commodities as well as anticipated residues (ARs) for other commodities, based on a combination of average field trial data and USDA/Pesticide Data Program (PDP) monitoring data. The chronic exposure estimates were further refined with percent crop treated (PCT) information for some crops. In some cases, DEEM (TM) (ver. 7.78) default processing factors were used, but empirical processing factors were used when available.

iii. Cancer . —a. Diuron. In conducting the cancer dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, the EPA analyses incorporated tolerance level residues for some commodities as well as anticipated residues (ARs) for other commodities, based on a combination of average field trial data and USDA PDP monitoring data. The cancer exposure estimates were further refined with PCT information for some crops. In some cases, DEEM (TM) (ver. 7.78) default processing factors were used, but empirical processing factors were used when available.

b. MCPDMU . EPA has identified MCPDMU as a potential residue of concern of diuron that may be found in drinking water but not found in food. In the absence of a metabolism study in fish, based on potential concern for residues of the drinking water, EPA conducted an assessment based on a worst-case dietary exposure analysis for the degradate MCPDMU, including residues in drinking water and a conservative estimate of potential residues in fish. EPA estimated the MCPDMU drinking water residue value of 1 ppb, based on monitoring data and assumed 25% (i.e., 0.5 ppm) of the residue in fish could be attributed to the degradate. This is a conservative assumption of a 500-fold accumulation of the degradate in fish, whereas acceptable metabolism studies in rat, ruminants and poultry indicate the majority of the residue in animals consists of dichlorinated and hydroxy metabolites; further, the rat metabolism study indicates diuron residues do not bioaccumulate. Therefore, the assumption that 25% of the tolerance-level residue in fish is comprised of the MCPDMU degradate is considered to be conservative.

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

Section 408(b)(2)(F) of the FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

a. The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue;

b. The exposure estimate does not underestimate exposure for any significant subpopulation group; and

c. Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT.

The Agency used PCT information as follows:

1% alfalfa, 1% almonds, 10% apples, 5% artichokes, 55% asparagus, 1% barley, 50% blackberries, 30% blueberries, 1% corn, 25% cotton, 20% filberts, 10% grapes, 45% grapefruit, 15% lemon, 50% limes, 20% Macadamia nut, 5% oats, 15% olives, 50% oranges, 10% peaches, 10% pears, 5% pecans, 90% mint, 1% pistachios, 30% raspberries, 15% sugarcane, 30% tangerines, 15% walnuts, and 1%wheat.

EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available federal, state, and private market survey data for that use, averaging by year, averaging across all years, and rounding up to the nearest multiple of five percent except for those situations in which the average PCT is less than one. In those cases <1% is used as the average and <2.5% is used as the maximum. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the single maximum value reported overall from available federal, state, and private market survey data on the existing use, across all years, and rounded up to the nearest multiple of five percent. In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), Proprietary Market Surveys, and the National Center for Food and Agriculture Policy (NCFAP) for the most recent six years.

There are existing tolerances for residues of diuron on peppermint, hay at 2 ppm. However, the EPA has determined the preferred commodity term should be peppermint, tops. Therefore, the PCT estimates used for mint are based on the existing registration and are not projections.

The Agency believes that the three conditions listed in Unit III.C.iv. have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which diuron may be applied in a particular area.

2. Dietary exposure from drinking water . The drinking water exposure assessment conducted in conjunction with the 2003 RED noted that surface water monitoring data resulted in diuron residues less than 1 parts per billion (ppb) ( http://www.regulations.gov , document 0006 - Docket ID EPA-HQ-OPP-2002-0249). For ground water, modeling results indicted that residues of diuron and degradates would be at most 0.6 ppb for long-term exposure assessment. For the current assessment, EPA used PDP monitoring data from 2003 and 2004, in which 1,072 samples of raw and treated water were analyzed for diuron residues. Residues were detected in 12 samples, ranging from 27 to 267 parts per trillion (ppt), with an average of 20.2 ppt (0.020 ppb). For chronic dietary risk assessment, the water concentration of value 0.020 ppb was used to access the contribution to drinking water. These estimates of drinking water concentrations were directly entered into the dietary exposure model.

The drinking water exposure assessment conducted in conjunction with the 2003 RED noted that surface water monitoring data resulted in diuron residues less than 1 ppb. For ground water, modeling results indicated that residues of diuron and degradates would be at most 0.6 ppb for long-term exposure assessment. The analysis in the RED noted that the potential for residues in drinking water sources is more likely to occur from run-off to surface water, and the ground water sources of drinking water are likely to be less vulnerable to contamination with diuron. The RED cited numerous monitoring studies from areas known for high diuron usage. The drinking water risks in the RED were calculated from diuron residues in a Florida surface water monitoring study in which the highest residue found was 1.2 ppb, but the 90 th and 95 th percentile residues were both less than the limit of detection in the study, which ranged from 0.2 to 0.4 ppb. For the current assessment, drinking water residues were estimated from PDP monitoring data from 2003 and 2004, in which 1,072 samples of raw and treated water were analyzed for diuron residues. Residues were detected in 12 samples, ranging from 27 to 267 ppt, with an average detected residue of 20.2 ppt (0.02 ppb). This average of detected residues was considered to be more appropriate for estimating cancer risk from drinking water than a high-end estimate of surface water residues from the Florida monitoring data. However, the 2 sets of monitoring data support the conclusion that potential residues in surface water are much less than 1 ppb.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

In conjunction with the RED, the agency concluded that all registered uses were eligible for reregistration, provided labeling requirements and mitigation measures were observed. This included voluntary cancellation of uses allowing application to home lawns. Currently, all registered labels for diuron no longer allow applications to home lawns. As a result the current uses registered that could result in non-occupational, non-dietary exposures are diruon added to paints and stains and residential ponds and aquariums.

Exposures of concern to diuron resulting from residential uses is expected to be negligible. The existing residential uses for diuron result in only short-term exposures, generally less than 7 days. No short-term dermal endpoints have been identified for diuron. A short-term incidental oral endpoint was identified. However, all residential uses to home lawns have been cancelled so incidental oral exposures are not expected. Inhalation endpoints have been identified for diuron. However, diuron has a low vapor pressure (2 x 10 - 7 mm Hg@30°C) and therefore, absorption by the inhalation route is likely to be low. Potential residential handler exposures from applying paints and stains containing diuron were assessed in the 2003 RED. Conservative assumptions included 2 days of painting per year for 50 years of a 70 year lifetime. However, based on information gathered through the RED process it was determined that less than 1% of paint sold contains diuron, and that such paints would likely only be used in rooms subject to high moisture (e.g., bathrooms). Therefore, lifetime exposure to home applicators of diuron-containing products is likely to negligible. Postapplication inhalation exposure resulting from the use of diuron in residential ponds and aquariums is also expected to be minimal based on the extremely high dilution rate. Therefore, an exposure assessment was not conducted for non-occupational, non-dietary exposures.

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

Based on available data, EPA has previously concluded that diuron, propanil and linuron, all of which contain 3,4 dichloroaniline (3,4-DCA) in their structures, do not share a common mechanism of toxicity. (Additional information regarding this conclusion can be found in the docket for the RED for diuron identified as EPA-HQ-OPP-2002-0249.)

Propanil readily metabolizes to 3,4-DCA, but neither diuron nor linuron metabolize to 3,4-DCA in plant or animal metabolism studies. EPA previously recommended against aggregating residues of 3,4 DCA for the propanil and diuron risk assessments. The following considerations support the recommendation:

• 3,4-DCA is a significant residue of concern for propanil, but is not a residue of concern per se for diuron;

• The analytical method for quantifying residues of concern from applications of diuron converts all residues to 3,4-DCA as a technical convenience. However, 3,4-DCA is not a significant residue in diuron plant and animal metabolism or hydrolysis studies. Therefore, the agency determined that all residues hydrolyzable to 3,4-DCA would be included in the tolerance expression for diuron, because no validated enforcement method is available for quantification for the actual residues of concern for diuron.

• Propanil and its metabolite 3,4-DCA were found to induce methemoglobinemia, the endpoint of concern for propanil. Diuron has not been shown to cause this effect. Diuron induces hemolytic anemia and compensatory hematopoiesis, which are mechanistically different from methemoglobinemia.

• Linuron and diuron metabolism studies show that both chemicals metabolize to DCPU and DCPMU. However, for reasons that are yet unknown, these chemicals do not induce the same toxic effects in mammals. Submitted data indicate that diuron is primarily (though not exclusively) metabolized by the hydroxylation of the urea group in either the methyl or the amino position and conjugated. Linuron, on the other hand, appears to be primarily ring-hydroxylated and conjugated. The methoxy group is removed, followed by the methyl group, with ring hydroxylation. Unlike linuron, hydroxylation of the phenyl ring is not a major metabolite pathway of diuron and, both methyl groups are lost.

• Methemoglobinemia is the dominant toxic effect of concern for linuron. As mentioned above, diuron does not induce methemoglobinemia. Mechanistic and reproductive studies show that linuron, and to some extent propanil, is an androgen receptor antagonist and that linuron induces testicular abnormalities in rodents. Studies with diuron showed no indications of any endocrine effects and no developmental or reproductive effects.

• Although the mechanisms of action for the differing effects induced by the two ureas, diuron and linuron, are not entirely known, there is sufficient cause to believe that exposures from the two compounds should not be cumulated.

• The estimated dietary cancer risk for diuron did not include residues from linuron and propanil since it was recognized that the target organs for tumor induction for diuron are different from those for linuron and propanil, and data were available which indicated that the mechanism of action may be different for diuron.

For the purposes of this tolerance action, therefore, EPA has not assumed that diuron has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/ .

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

2. Prenatal and postnatal sensitivity . There is an acceptable developmental toxicity study in rabbits and an acceptable 2-generation reproduction study in rats. A developmental toxicity study in rats was classified as unacceptable due to deficiencies in analytical data on the sample analysis; however, the EPA considers the developmental toxicity study in rats adequate for the FQPA susceptibility assessment based on the observation that the developmental toxicity NOAEL was higher than the maternal NOAEL. The EPA has also concluded that a developmental neurotoxicity (DNT) study is not required.

There is no indication of increased susceptibility to young exposed to diuron in the available studies. In the developmental toxicity study in rabbits, there were no developmental effects at the highest dose tested. In the developmental toxicity study in rabbits and in the 2-generation rat reproduction study, developmental/offspring effects were observed only at maternally/parentally toxic dose levels.

There are no neurotoxic signs in any of the submitted subchronic or chronic studies.

3. Conclusion . The chronic dietary endpoint for diuron used in risk assessment is based on a LOAEL of 1 mg/kg/day from the chronic toxicity/carcinogenicity study in rats. EPA has retained the 10X FQPA safety factor for diuron because of reliance on a LOAEL in the rat chronic toxicity study and because the data in that study or other studies did not show that a smaller factor would be safe. EPA has determined that reliable data show that it would be safe for infants and children provided the FQPA safety factor of 10X is retained and no additional safety factors are needed. That decision is based on the following findings:

i. There are no uncertainties with the toxicology database other than with regard to the lack of a NOAEL in the rat chronic toxicity study. The only outstanding toxicity data requirement for diuron is a 28-day inhalation study which is required to address the concern for inhalation exposure to workers during the application of diuron. Occupational exposures are not considered under section 408 of FFDCA. Postapplication inhalation exposure resulting from the indoor use of diuron in paints is expected to be minimal because of the low vapor pressure of diuron, and because diuron-treated paint is only likely to be used in rooms where high humidity is expected (e.g... a bathroom), and would rarely be used in the entire house based on the use pattern. Additionally, based on information gathered through the RED process it was determined that less than 1% of paint sold contains diuron. As a result, non-occupational exposure to diuron via inhalation is not expected to occur with infants and children. Therefore, the 28-day inhalation study will not change the endpoints used in risk assessment to address the potential risks to infants and children.

The developmental toxicity study in rats is classified as unacceptable due to deficiencies in analyses of the test material and dosing solutions. However, the EPA has not required the study be repeated since it is considered adequate for the FQPA susceptibility assessment based on the observation that the developmental toxicity NOAEL was higher than the maternal NOAEL, and because maternal and developmental toxicity were well-defined at their respective LOAELs. Finally, the rabbit is considered to be the more sensitive species than the rat for developmental toxicity, and the rabbit developmental study is acceptable. The chronic toxicity study in dogs has also been classified as unacceptable due to the purity of the test material, as well as potential problems with stability and homogeneity issues related to the test material. However, the EPA determined that a repeated chronic dog study is not required; similar effects were observed in rats and dogs, but the effects in the rat occurred at lower doses and the rat NOAEL serves as the dose for risk assessment. Therefore, the EPA concluded that a new chronic dog study would not change the endpoint chosen for risk assessment.

The data base as a whole is adequate for pre- and post-natal toxicity evaluation.

ii. There is no indication of quantitative or qualitative increased susceptibility of rats or rabbits to in utero or postnatal exposure. There is no indication of increased susceptibility to young exposed to diuron in the available studies. In the developmental toxicity study in rabbits, there were no developmental effects at the highest dose tested. In the developmental toxicity study in rabbits and in the 2-generation rat reproduction study, developmental/offspring effects were observed only at maternally/parentally toxic dose levels.

iii. There are no neurotoxic signs in any of the submitted subchronic or chronic studies. A developmental neurotoxicity study (DNT) for diuron is not required.

iv. There are no residual uncertainties identified in the exposure databases. The dietary (food and drinking water) and non-dietary (residential) exposure assessments will not underestimate the potential exposures for infants and children. The dietary food exposure assessments were performed based on reliable field trial data where tolerance level residues for some commodities as well as anticipated residues (ARs) for other commodities, based on a combination of average field trial data and USDA/PDP monitoring data. Average PCT values were assumed for chronic dietary assessment for some crops and 100 PCT treated were assumed for the remaining uses. Drinking water estimates were based on monitoring studies and USDA/PDP monitoring data. EPA expects any residential exposure from use of diuron to be negligible. The EPA is confident that these assessments will not underestimate the exposure and risks posed by diuron.

Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (“aPAD”) and chronic population adjusted dose (“cPAD”). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (“MOE”) called for by the product of all applicable uncertainty/safety factors is not exceeded.

1. Acute risk . As there were no toxic effects attributable to a single dose, an endpoint of concern was not identified to quantitate acute-dietary risk to the general population or to the subpopulation females 13-50 years old. No acute risk is expected from exposure to diuron.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to diruon from food and water will utilize 19% of the cPAD for the population group children 1-2 years old, the subpopulation group with greatest exposure. There are no residential uses for diuron that result in chronic residential exposure to diuron.

3. Short-term risk and Intermediate risk . Short-term and intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). The current uses registered that could result in non-occupational, non-dietary exposures are from diuron added to paints and stains as well as applications to residential ponds and aquariums. However, EPA expects any residential exposure from use of diuron to be negligible. Therefore, no short-term and intermediate-term risk is expected from exposure to diuron as a result of non-occupation, non-dietary exposures.

4. Aggregate cancer risk for U.S. population . Using the exposure assumptions described in this unit for cancer for diuron, EPA has concluded that exposure to diruon from food and water will result in a cancer risk estimate of 1.4 x 10 - 6 for the general U.S. population. This risk estimate is within the range of 1 in 1 million that EPA considers negligible risk for cancer. EPA has generally concluded that computed cancer risks as high as 3 in 1 million fall within this risk range.

Using the exposure assumptions described in this unit for cancer for the degradate MCPDMU, EPA has concluded that exposure to MCPDMU from fish and water will result in a cancer risk estimate of 5.9 x 10 -7 , which is not of concern.

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

Adequate enforcement methodology (gas chromatography) is available to enforce the tolerance expression. The principle of the determination is the hydrolysis of diuron and its metabolites by alkaline reflux to 3,4-dichloroanaline (3,4-DCA), followed by a distillation of the aniline into an acid solution. The acid distillate is made alkaline with concentrated base and subsequently extracted into an organic solvent (hexane) and analyzed by gas chromatography. With the modified method, recoveries exceeded 70% and the limit of quantitation (LOQ) is 0.01. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

There are no Codex, Canadian, or Mexican tolerances or maximum residue limits for diuron in cactus; spearmint, tops; peppermint, tops; and fish - freshwater finfish, farm raised. Therefore, harmonization with international tolerances is not an issue for this action.

Several comments were received from a private citizen objecting to establishment of tolerances. The Agency has received similar comments from this commenter on numerous previous occasions. Refer to Federal Register of June 30, 2005 (70 FR 37686; FRL-7718-3); January 7, 2005 (70 FR 1354; FRL-7691-4); and October 29, 2004 (69 FR 63096; FRL-7681-9) for the Agency's response to these objections. In addition, the commenter noted several adverse effects seen in animal toxicology studies with diruon and claims because of these effects no tolerance should be approved. EPA has found, however, that there is a reasonable certainty of no harm to humans after considering these toxicological studies and the exposure levels of humans to diruon.

The EPA also received an additional comment in support of this action.

Upon completing review of the current diuron database, the Agency concluded that the tolerance expression proposed in the Notice of Filing should be changed to include metabolites hydrolyzable to 3,4-dichloroaniline (3,4-DCA). This determination is based on the results of the reviewed plant and animal metabolism studies.

Currently, there are existing tolerances for residues of diuron on peppermint, hay at 2 ppm. The petitioner proposed tolerances be established on mint at 1.5 ppm. The EPA has determined that the preferred commodity terms are spearmint, tops and peppermint, tops and based on the residue field trial data the appropriate tolerance level for spearmint and peppermint should be 1.5 ppm. The EPA has also determined the preferred commodity terms should be cactus and fish - freshwater finfish, farm raised.

Therefore, these tolerances are established for combined residues of diuron (3-(3,4-dichlorophenyl)-1,1-dimethylurea and its metabolites convertible to 3,4-dichloroaniline on cactus at 0.05 ppm, spearmint, tops at 1.5 ppm, peppermint, tops at 1.5 ppm and fish - freshwater finfish, farm raised at 2.0 ppm.

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

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

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

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

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

I. Background II. Resolution of Comments III. Procedural Requirements A. Review Under Executive Order 12866 B. Review Under Executive Order 12988 C. Review Under the Regulatory Flexibility Act D. Review Under the Paperwork Reduction Act E. Review Under Executive Order 12612 F. Review Under the Unfunded Mandates Reform Act of 1995 I. Background

On November 22, 2006, the U.S. Agency for International Development (USAID) published a notice of proposed rulemaking (71 FR 67518), which proposed to develop a program that encouraged USAID prime contractors to assist small business, including veteran-owned small business, service-disabled small business, HUBZone, small socially and economically disadvantaged business, and women-owned small business in enhancing their capabilities to perform contracts and subcontracts for USAID and other Federal agencies. Comments on this proposed rule were extended to and closed on February 22, 2007 (71 FR 70939).

Successful Mentor-Protégé arrangements represent opportunities for creating access for small business to USAID contracts and awards let through negotiated procurements. USAID received comments on the proposed rule suggesting the Agency clarify the eligible participants in the Program and the types of incentives USAID may provide to prime contractors for providing developmental assistance to protégés. After careful consideration of the public comments received on the notice of proposed rulemaking, USAID today publishes a final rule.

Fourteen comments were received in response to the proposed rule. The comments and USAID's responses are as follows:

Comment: USAID's implementation of its Mentor-Protégé Program must be narrowly tailored within SBA's statutory and regulatory constraints, absent USAID-specific statutory authority.

Response: USAID agrees that its Mentor-Protégé Program must stay within SBA regulations and USAID-specific statutory authority.

USAID received two comments related to Minority Serving Institutions in the proposed rule.

Comment 1 states: We support the inclusion of Minority Serving Institutions (MSIs) as eligible protégés but recommend that the expanded description of MSIs in this (the Purpose) section be deleted since it is specifically covered as a definition in section 719.273-2(b) and in FAR 2.101-2.

Comment 2 states: We support the inclusion of Minority Serving Institutions (MSIs) as eligible mentors, but question USAID's authority to use MSIs as small business concern protégés.

Response: USAID intended to include MSIs in the scope of this program. However, doing so would be outside its statutory authority. USAID agrees that it does not currently have the statutory authority for this provision and has deleted this requirement from the Mentor-Protégé Program regulations. References to MSIs as mentors or protégés have been deleted from the final rule.

USAID received two comments related to the treatment of “affiliation” in the proposed rule.

Comment 1 states: We appreciate the affirmation included in this (Purpose) section that a protégé firm is not considered an affiliate of a mentor solely because of the developmental assistance the protégé receives under the Program but recommend that this statement be moved to section 719.273-2(a) where it more appropriately relates to the definition of a “small business.”

Comment 2 states: We do not believe that [USAID] has the authority to waive the SBA's affiliation requirements, as set forth in 13 CFR 121.103.

Response: USAID does not intend to establish affiliate relationships or waive the SBA affiliation requirements, as doing so is not within the USAID statutory authority. The final rule is clarified in section 719.273-2.

Comment: We strongly support the formulation that a mentor may have more than one protégé providing that each relationship complies with the terms and conditions of the regulations and the mentor can demonstrate that it has the capacity to provide developmental assistance appropriate to the specific protégé. However, this language is already more appropriately addressed in sections 719.273-4(b) and 719.273-5(b) and thus should be deleted from this [Purpose] section.

Response: USAID agrees with this comment and has modified the final rule.

Comment: The commenter cites a portion of section 719.273-1 which concludes with a statement that USAID reserves the right “to limit the total number of protégés participating” in the Program. The Agency has not disclosed why it has an interest in establishing limits on participation in the program. It is also unclear whether this statement means that the Agency would limit the number of protégés a mentor could have or whether it is intended to operate as an overall limit of the number of mentor firms in the Program. For example, [Section] 719.273-5(b) states that USAID reserves the right to limit the number of protégés participating under each mentor firm * * * By contrast, in the Paperwork Reduction Act discussion in the Background section accompanying the rule the Agency “estimates” that there would be a total of thirty firms required to complete the application form. Regardless, we believe the issue of any Agency imposed limits, if there are to be any, is more appropriately addressed elsewhere in the substantive provisions of the rule.

Response: The commenter addresses several attributes of the Program, some of which are clarified in the final rule. USAID confirms its intent to reserve the right to limit the total number of participants in the Program, as expressed in section 719.273-4, in order to insure its effective management of the Program. The formulation in section 719.273-5(b) is clear in its intent to reserve the right to limit the number of protégés participating under each mentor under the Program, in order for USAID to effectively manage the Program, to conduct due diligence on all Mentor-Protégé Agreements, and to assure the developmental assistance proposed in the Agreements is being provided by the mentor to the protégé(s). The discussion on the Paperwork Reduction Act in the Background section is intended to provide an estimate of the number of participants from the U.S. business community to participate in the Program and was not intended to set a predetermined limit on the number of participants in the Program. USAID will monitor the number of Agreements endorsed (participants accepted into the Program) and in effect between the firms within a given period of time. These Agreements will be entered by firms in the public domain outside the controls of the USAID, but USAID imposes these measures to potentially limit participation in the Program to assure the integrity of the Mentor-Protégé Program. USAID agrees to reflect this concern in the Internal Controls section 719.273-10(a)(4) of the final rule.

Comment: Addressing the definitions in section 719.273-2, commenter noted that the categories of firms eligible to participate in the Program are already covered in a more inclusive manner as a defined term in paragraph (a) of this Section and recommended deleting the listing in paragraph (e).

Response: USAID disagrees with this comment and believes that there is merit in listing the categories of small business firms in both the new introductory paragraph of the section and in the specific definition of a Protégé.

Comment: (Referring to the last sentence of undesignated first paragraph of section 719.273-4) We recognize that the goal of the Mentor-Protégé Program is to expand the opportunities for small businesses to participate in USAID procurements. However, based on the capabilities of the prospective protégé firm and the developmental assistance it may need, it may be unreasonable to expect a prospective mentor firm to include the prospective protégé in the subcontracts at the outset of an Agreement. We believe USAID intended the scope of opportunities for prospective firms to be as broad as possible and that the Agency did not intend to restrict prospective protégés to only those firms that are already qualified as potential prime contractors or as subcontractors under a mentor's prime contract * * *. We encourage USAID to clarify this important issue of eligibility in this paragraph.

Response: USAID does not expect nor will it require a prospective mentor firm to include the prospective protégé in the subcontracts at the onset of an Agreement. USAID has clarified this issue of eligibility in the final rule.

Comment: The commenter, citing the Federal Acquisition Regulation, states that USAID relies on 15 U.S.C. 637(d)(4)(E) for its authority to provide appropriate incentives to encourage subcontracting opportunities for small business consistent with the efficient and economical performance of the contract * * * [A]lthough USAID could provide certain evaluation preferences to mentors and protégés with an approved Agreement, [commenter did] not see how USAID can provide the subcontracting credit that is set forth in the proposed rule, noting that the Department of Defense needed specific statutory authority for their Mentor-Protégé Program to provide for subcontracting credits.

Response: USAID agrees that it currently does not have statutory authority to permit credit for subcontracting and has modified the final rule accordingly, to refine the language in 719.273-3(b). We are concerned about making the Program attractive to mentors and protégés through allowable incentives under its statutory authority. After reviewing incentives offered by other U.S. Government agencies and as permitted by our regulations, we revised this section, using the Environmental Protection Agency (EPA) program as a model. Under the same Small Business Act authority cited above, EPA has provided certain “incentives” for mentors, as codified in 48 CFR 1552.219-71(j); their regulation states that costs incurred by the offeror in fulfilling their agreement with a protégé firm are not reimbursable as a direct cost under the contract, but if EPA is the responsible audit agency, these costs will be considered in determining indirect cost rates. In the final rule, USAID's “incentive” is similar to one provided by EPA.

Comment: When referencing a term such as “small business,” HUBZone, etc., USAID should be referring the reader to SBA's regulations rather than the FAR. The term as used in USAID's regulation should also be consistent with the term as defined in 13 CFR.

Response: USAID has modified the final rule accordingly.

We received two comments on section 719.273-4(b)(1)(ii). The first commenter noted that the section provides that the applicable NAICS code for determining small business status is the services or supplies to be provided by the Protégé to the mentor, but that “the January 2006 application form prescribes that small business eligibility is based on the primary NAICS code for the small business concern. These two differing standards must be reconciled. We support the formulation used in the rule.” The second commenter asked that USAID clarify that the protégé must be small for the NAICS codes assigned to the subcontract by the prime contractor (13 CFR 121.405).

Response: In the final rule, USAID indicates that the protégé must be small for the NAICS codes designated by the mentor, based on the supplies or services the protégé may provide to the mentor under a subcontract, in cases where there is a subcontract. USAID is not limiting protégé eligibility to only those small businesses that have a subcontract with the mentor, so we do not want the final rule to appear to make such a limitation. The comment about the application form is outside the scope of the proposed and this final rule.

Comment: The Summary of the proposed rule is not in agreement with the language in the proposed regulation and may be misleading.

Response: USAID agrees and has modified the rule to harmonize the summary and the language of the regulation.

Comment: The clause reference 752.219-270 should be 752.219-70.

Response: USAID agrees and deleted the number “2” from clause reference 752.219-70.

Comment: In section 719.273-4 Eligibility of Mentor and Protégé Firms (b)(2), please clarify that the applicable certifications must be in accordance with SBA's Program regulations contained in 13 CFR 124 and 126.

Response: USAID agrees and has modified the final rule accordingly.

Today's regulatory action has been determined to be a “significant regulatory action” under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Accordingly, this final rule was subject to review under that Executive Order by the Office of Information and Regulatory Affairs of the Office of Management and Budget (OMB).

With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (February 7, 1996), imposes on Executive agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) Write regulations to minimize litigation; and (3) Provide a clear legal standard for affected conduct rather than a general standard and promote simplification and burden reduction. With regard to the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the subject law's preemptive effect, if any; (2) Clearly specifies any effect on existing Federal law or regulation; (3) Provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) Specifies the retroactive effect, if any; (5) Adequately defines key terms; and (6) Addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. USAID has completed the required review and determined that these proposed regulations meet the relevant standards of Executive Order 12988.

This final rule has been reviewed under the Regulatory Flexibility Act of 1980, Public Law 96-354, that requires preparation of an initial regulatory flexibility analysis for any rule that must be proposed for public comment and that is likely to have significant economic impact on a substantial number of small entities. Small entities include small business, small organizations, and small governmental jurisdictions.

For purposes of assessing the impact of today's rule on small entities, small entity is defined as: (1) A small business that meets the definition of a small business found in the Small Business Act and codified in 13 CFR 121.201; (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; or (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives “which minimize any significant economic impact of the proposed rule on small entities.” (5 U.S.C. 603 and 604) Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule. In fact, the purpose of the USAID Mentor-Protégé Program is to increase small business accessibility to USAID contracting. This rule streamlines USAID internal operating procedures and will therefore not have a significant economic impact on small entities.

This rule requires USAID Mentor-Protégé Program participants to submit an application (see section 719.273-7) and annual progress reports to the USAID Mentor-Protégé Program Manager at USAID Headquarters (see section 719.273-10). The information in the reports is necessary to determine the value of the developmental assistance and if the schedules and developmental assistance levels contained in Mentor-Protégé Agreements are being met. Performance under the Agreements is the basis for providing proper recognition to Mentor firms. USAID submitted the proposed collection of information to the Office of Management and Budget for review and approval under the Paperwork Reduction Act, 44 U.S.C. 3501, et seq. The Office of Management and Budget has not yet approved the collection of information in this rule.

An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number (5 CFR 1320.5(b)).

Executive Order 12612, (52 FR 41685, October 30, 1987), requires that regulations, rules, legislation, and any other policy actions be reviewed for any substantial direct effects on States, on the relationship between the Federal Government and the States, or in the distribution of power and responsibilities among the various levels of Government. If there are sufficient substantial direct effects, then the Executive Order requires the preparation of a federalism assessment to be used in all decisions involved in promulgating and implementing a policy action. States would not be directly subject to this rule, since they are not among the class of entities described as Mentors or Protégés. USAID has determined that this rule would not have a substantial direct effect on the institutional interests or traditional functions of the States.

The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) generally requires a Federal agency to perform a detailed assessment of costs and benefits of any rule imposing a federal mandate with costs to State, local or tribal governments, or to the private sector of $100 million or more. This rulemaking would only affect private sector entities, and the impact is less than $100 million.

A. Background

On May 23, 2005, the Cost Accounting Standards Board published an interim rule with request for comment (70 FR 29457) for the purpose of revising the criteria applicable to United Kingdom (UK) contractors for filing a Disclosure Statement, Form No. CASB DS-1. The interim rule was adopted in order to comply with a specific request by the UK Ministry of Defence (MOD) to simplify the compliance process with CAS Board disclosure requirements for UK contractors.

Unlike certain other foreign contractors, UK contractors have been required to file a CASB DS-1 in accordance with CAS regulations. The MOD initially approached the Board with a request that UK contractors be permitted to use the corresponding UK form “Questionnaire on Method of Allocation of Costs” (QMAC), in lieu of the CASB DS-1. After a review of the content of the QMAC, the UK and U.S. representatives agreed that it did not have the same scope as the CASB DS-1. Therefore, it was agreed that to cover the gap in the coverage a “Supplemental QMAC” was needed.

Based upon the Board's approval of a Supplemental QMAC that is acceptable to the MOD, the MOD requested that the CAS Board allow UK contractors to submit their basic QMAC, together with the Supplemental QMAC, in lieu of the DS-1. At its meeting on February 23, 2005, the Board agreed to change the CAS requirements so that UK contractors with CAS-covered contracts may file the UK QMAC together with its Supplement in lieu of the CASB DS-1 required of U.S. contractors. In conjunction with this change, the Board also agreed to eliminate the specific paragraph addressing UK contractors at 9903.201-1(b)(12). As a result, UK contractors are subject to the requirements of 9903.201-1(b)(4), i.e. , contracts and subcontracts with UK contractors are exempt from CAS “insofar as the requirements of CAS other than 9904.401 and 9904.402 are concerned.” The May, 2005 interim rule reflected these Board approved revisions.

The Board received one set of public comments in response to the Interim Rule.

Comment: The commenter requested confirmation that the rule requires that UK contractors comply only with CAS 401 and 402.

Response: The language in the final rule requires that all UK contractors performing U.S. Government contracts and not otherwise exempt under 48 CFR 9903.201-1 will be required to comply only with CAS 401 and 402 in accordance with 48 CFR 9903.201-1(b)(4).

Comment: The commenter expressed concern that UK contractors are subject to more extensive disclosure requirements than other countries listed in 48 CFR 9903.201-4(e) by virtue of the QMAC Supplement.

Response: The Board believes that the disclosure requirements for UK contractors provide the information necessary for the UK MOD to determine whether such contractors are complying with the provisions of CAS 401 and 402. The MOD initially requested that its contractors be permitted to file only the QMAC. However, as described in the Background section above, the Board determined that the QMAC, by itself, did not provide sufficient information about the accounting practices of UK contractors. Therefore, working jointly with the MOD, the QMAC supplement was developed to minimize duplicate disclosures while providing the additional information needed to cover the gap between the QMAC and CASB DS-1.

The Paperwork Reduction Act, Public Law 96-511, does not apply to this rulemaking, because this rule imposes no paperwork burden on offerors, affected contractors and subcontractors, or members of the public which requires the approval of OMB under 44 U.S.C. 3501, et seq.

The Board certifies that this rule will not have a significant effect on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5. U.S.C. 601, et seq. , because small businesses are exempt from the application of the Cost Accounting Standards.

The Council adopted Amendment 13 to the Scallop FMP on February 7, 2007, and submitted it to NMFS on February 16, 2007, for review and approval. The Council developed Amendment 13 to permanently re-active the industry-funded scallop observer program implemented by NMFS via emergency rule in 2006. Observer coverage in the scallop fishery is necessary to monitor the bycatch of finfish, including yellowtail flounder, skates, monkfish, cod, and other species. Monitoring of yellowtail flounder bycatch in the Scallop Access Areas within the year-round closed areas under the Northeast (NE) Multispecies FMP is of particular concern because the scallop fishery is constrained by a fishery-specific TAC of yellowtail flounder, an overfished species, which is part of the stock-wide yellowtail flounder TACs set by the NE Multispecies FMP to achieve specified mortality targets for the species. Observer coverage is also needed to monitor interactions of the scallop fishery with endangered and threatened sea turtles. A proposed rule for Amendment 13 was published on April 6, 2007 (72 FR 17076). The public comment period for the proposed rule ended on May 7, 2007. The notice of availability for the amendment published on March 19, 2007, and its required 60-day comment period closed on May 18, 2007. This rule implements management measures associated with the scallop observer program, which are described in detail below.

In the proposed rule, NMFS requested comments on all proposed management measures. The approved management measures are discussed below; no measures in Amendment 13 were disapproved. Details concerning the development of these measures were presented in the preamble of the proposed rule and are not repeated here.

Amendment 13 allows any entity to become an observer service provider if it meets the approval and responsibilities criteria. Potential observer service providers are required to submit an application containing detailed information such as contact information, description of past experience with placing individuals in remote field and/or marine environments, evidence of adequate insurance to cover injury, liability and accidental death for observers during employment, and proof of compensation for observers while employed that meet or exceed Department of Labor guidelines. Entities interested in being included on the list of NMFS-approved observer service providers are required to submit an application with the information described in the regulatory text of this action. Upon receipt of an application, NMFS will provide all potential observer service providers with an estimated number of observer sea days for the fishing year. Additionally, a planned schedule of observer deployments will be posted on this NOAA Web site: http://www.nefsc.noaa.gov/femad/fsb/. NMFS will notify candidate observer service providers of their approval or disapproval within 15 days of its receipt of their applications. If approved, the observer service provider's name will be added to the list of NMFS-approved observer service providers.

Observer service providers will be required to comply with all observer support, deployment logistics and limitations, communication, training, reporting, and conflict of interest requirements in the regulatory text of this action. Observer service providers will also be responsible for setting the daily cost of observer coverage on a vessel. NMFS will continue to be responsible for determining the reduced DAS accrual rate and TAC for the set-aside program to defray the cost of observer coverage through biennial specifications. This NMFS-approval process will maintain quality control of the data collected, but will not have potential conflicts with augmentation of appropriations law and policy.

Amendment 13 implements a few minor changes from the observer service provider requirements implemented by NMFS in 2006 via emergency rule. The cost of training/certifying scallop observers is borne by NMFS. To facilitate cost-effective training/certification, Amendment 13 requires a minimum class size of eight observers, which may be split among multiple observer service providers, to be enrolled in the scallop observer training class operated by the Northeast Fisheries Observer Program (NEFOP). Training classes with fewer than eight participants will be delayed until at least eight participants are enrolled. Amendment 13 also requires that an approved observer service provider maintain in its employ at least eight observers that had been certified through the scallop observer training class operated by NEFOP. The emergency rule required that an observer's first deployment shall be on a Scallop Access Area trip and that the resulting data be edited and approved by NMFS prior to any further deployments. Specifying details of new observer's first deployment was designed to provide the necessary oversight to ensure the collection of timely and accurate data. However, NEFOP has learned that requiring an observer's first deployment and the resulting data be edited and approved by NMFS, prior to any further deployments, is sufficient for quality control, and that requiring an observer's first deployment be on a Scallop Access Area trip may limit the availability of observers to provide coverage on scallop trips to open areas. Therefore, the requirement that an observer's first deployment and the resulting data be edited and approved by NMFS, prior to any further deployments, is implemented in this action, but the requirement that an observer's first deployment shall be on a Scallop Access Area trip is not.

Amendment 13 requires that employees of observer service providers must meet the NMFS National Minimum Eligibility Standards available at http://www.st.nmfs.gov/st4/nop/ and must pass the NEFOP training course and be physically and mentally capable of carrying out the responsibilities of an observer. NMFS has the authority to review observer certification and issue observer certification probation and/or decertification if warranted. One minor addition to the observer certification requirements implemented by emergency rule is that Amendment 13 requires that all observers hold a current Red Cross (or equivalent) cardiopulmonary resuscitation/first aid certificate.

Amendment 13 specifies criteria and protocols for removal of an observer service provider from the list of NMFS-approved observer service providers and the probation and decertification of an observer.

Amendment 13 specifies general requirements for scallop vessels, notification procedures, and requirements of the vessel if it is selected to carry an observer. Vessels are responsible for paying the cost of an observer, regardless of whether the vessel lands or sells scallops on that trip, and regardless of the availability of set-aside TAC or reduced DAS accrual rate.

The emergency rule required that vessels contact NMFS prior to the 25th day of the month preceding the month in which it intends to fish. This requirement was designed by NMFS to provide NEFOP with an estimate of fishing effort to expect in the following month, so that observer coverage needs could be met. However, NEFOP has found that it does not need this provision to meet coverage needs; therefore, that notification requirement is not implemented in Amendment 13.

Lastly, Amendment 13 provides for a framework mechanism to implement future adjustments to the scallop observer program. Under the Scallop FMP, and in accordance with the Administrative Procedure Act, the framework process allows for rulemaking to amend observer requirements without the need to also amend the FMP. Currently, adjustments to the observer program must be made through an amendment to the Scallop FMP. Providing for a framework mechanism in the Scallop FMP to make adjustments to measures implemented for the observer program will allow the Council more flexibility to develop improvements to the observer program.

NMFS received two comment letters on Amendment 13.

Comment 1: The first comment expressed concern about the lack of Federal support for observer coverage of the scallop fishery. The commenter stated that the Scallop FMP requirement that industry pay for observer coverage was intended to provide observer coverage for trips into Scallop Access Areas, but not observer coverage on trips into open areas. The commenter acknowledged that the Scallop FMP's set-aside program generally does have a positive economic effect. However, the commenter cautioned that using the set-aside to pay for observer coverage may become burdensome for the industry if the abundance or price of scallops declines, especially for observer coverage in open areas. Instead, the commenter proposed that NMFS use Federal funds to pay for observer coverage in open area trips, to the extent that such funding is available.

Response: The Scallop FMP requirement for industry to pay for observer coverage and the level of set-aside available to help defray the cost of observer coverage are not addressed in Amendment 13. However, they were established after being considered in prior scallop actions, particularly Amendment 10, the action that established the current set-aside program in July 2004. Amendment 13 only establishes the mechanism to allow the set-aside to be used; it does not adjust the set-aside program. If this action is implemented, future adjustments to the set-aside program, including adjustments evaluating the commenter's concerns, could be implemented by framework action.

Comment 2: The second comment cautioned that a conflict of interest can result from industry-funded observer programs, leading to inaccurate and biased data. The commenter proposed camera surveillance as a better means to collect data.

Response: NMFS concurs with the commenter that conflict of interest is an important issue to consider when developing an industry-funded observer program. Therefore, to minimize the likelihood that an observer would develop ties to a vessel owner/operator and/or feel pressured by a vessel owner/operator to misreport, Amendment 13 prohibits observer service providers from consecutively deploying the same observer on the same vessel and from deploying an observer on the same vessel more than twice a month. The Council did not consider electronic monitoring for the scallop fishery in Amendment 13, but as technology develops, electronic monitoring may be considered in a future action.

In § 648.14, paragraph (h)(17) is revised to include the correct cross-reference.

In § 648.14, paragraph (i)(15) is added to clarify the prohibition to be consistent with paragraph (h)(17).

The Administrator, Northeast Region, NMFS, determined that FMP Amendment 13 is necessary for the conservation and management of the Atlantic sea scallop fishery and that it is consistent with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) and other applicable laws.

NMFS approved Amendment 13 on May XX, 2007. A copy of the Amendment is available from the Council and NMFS (see ADDRESSES ).

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

There is good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effective date for Amendment 13. Because Amendment 13 maintains a mechanism for an industry-funded observer program that has been in place since last year, delaying the effective date of Amendment 13 would be more disruptive and would cause more economic and resource conservation concerns than waiving the delay in effective date.

Amendment 13 permanently implements, with minor modifications, the industry-funded scallop observer program implemented by NMFS through an emergency rule in 2006. Observer coverage in the scallop fishery is necessary to monitor groundfish bycatch, particularly yellowtail flounder bycatch in the Scallop Access Areas. It is also needed to monitor interactions between the scallop fishery and sea turtles, especially in the Mid-Atlantic during June through October. The emergency rule that implemented the industry-funded scallop observer program in 2006 expires on June 11, 2007, and the Scallop Access Areas open on June 15, 2007.

To prepare for the opening of the Scallop Access Areas, NMFS recently completed a three-week training course for 20 observers for the industry-funded scallop program. The cost of this training was approximately $112,640 (approximately $5,632 per observer) and included lodging, meals, travel, salary, leasing training vessels, safety training, and security clearances. If there is a delay in effective date of Amendment 13 and these observers are not able to work, they will likely move on to other jobs and additional observers would need to be found and trained. Because trained observers are valuable and difficult to replace, it would take a minimum of three months to locate and train additional observers. Additionally, there would be a loss of income, potentially severe, for observer service providers who employ industry-funded observers for the scallop fishery, if there is a delay in effective date in Amendment 13 resulting in a lapse of an industry-funded observer program.

NMFS's current and anticipated funding only provides for minimal observer coverage in the scallop fishery. Delaying the implementation of Amendment 13, and its provision for an industry-funded observer coverage in the scallop fishery, would likely result in less than sufficient observer coverage levels for monitoring the yellowtail flounder bycatch in Scallop Access Areas when they open on June 15, 2007. Scallop Access Areas have restrictive yellowtail flounder bycatch TACs that require close monitoring to achieve specified mortality targets. Observer data are used to calculate yellowtail flounder catch rates in these areas and catch rates are extrapolated to unobserved trips. Observer coverage is essential in order to project TAC attainment and close the Scallop Access Areas. Closing Scallop Access Areas after the yellowtail flounder bycatch TACs for Scallop Access Areas are exceeded could result in exceeding mortality targets for an overfished stock, thereby slowing rebuilding of an overfished stock, and potentially conflicting with requirements of National Standard 1 of the Magnuson-Stevens Act to rebuild overfished stocks within a specified time period. Additionally, observer coverage to monitor interactions between the scallop fishery and sea turtles is particularly important during June through October. Sea turtles are known to occur in areas where the scallop fishery operates during this period and sea turtle takes in scallop trawl and dredge gear have been observed during these months. Delaying the implementation of Amendment 13 would also likely result in less than sufficient observer coverage to document interactions between the scallop fishery and sea turtles in June, and perhaps July. Even though compliance with the Endangered Species Act (ESA) does not require observer coverage in the Mid-Atlantic scallop fishery because of mandatory gear modifications, observer coverage of the scallop fishery continues to provide important information to advance knowledge of how, where, and to what extent ESA-listed sea turtles interact with dredge and trawl gear used in the scallop fishery.

Lastly, the management effects of having minimal observer coverage in the scallop fishery during June, and possibly July could result in negative economic impacts on the scallop industry for the 2007 fishing year. Scallop harvest from Scallop Access Areas is a substantial source of income for the scallop fleet. Should these areas close earlier than necessary because of less reliable data on yellowtail flounder bycatch, the fleet would experience reduced fishing opportunities and reduced harvest.

For these reasons, there is good cause to waive the 30-day delay in effectiveness for Amendment 13. The need for this waiver is due to the timing of the amendment's submission by the Council to NMFS. Amendment 13 was adopted by the Council on February 7, 2007, and was submitted to NMFS for review and approval on February 16, 2007. The notice of availability for the amendment published on March 19, 2007, and its required 60-day comment period closed on May 18, 2007. The proposed rule for Amendment 13 published on April 6, 2007, and its 30-day comment period closed on May 7, 2007.

A final regulatory flexibility analysis (FRFA) was prepared. The FRFA incorporates the IRFA, a summary of the significant issues raised by public comment in response to the IRFA, NMFS responses to those comments, and the corresponding economic analyses prepared for Amendment 13. The contents of these incorporated documents are not repeated in detail here. A copy of Amendment 13 and the IRFA are available upon request (see ADDRESSES ).

The objective of this action is to re-activate the industry-funded observer program for the scallop fishery. Observer coverage is necessary in the scallop fishery to monitor bycatch of finfish and interactions with endangered and threatened species. The need for this action is to provide a mechanism to approve observer service providers so that the set-aside program can be utilized to help defray costs of carrying the necessary level of observers in the scallop fishery. A complete description of the reasons why this action is being implemented, and the objectives of and legal basis for this action, is contained in the preamble to the proposed rule (72 FR 17076, April 6, 2007) and is not repeated here.

As discussed in the preamble, an industry representative commented that the Scallop FMP requirement for industry to pay for observer coverage was intended to provide observer coverage for trips into Scallop Access Areas, but not observer coverage on trips into open areas. The commenter acknowledged that the Scallop FMP's set-aside program generally does have a positive economic effect. However, the commenter cautioned that using the set-aside to pay for observer coverage may become burdensome for the industry if the abundance or price of scallops declines, especially for observer coverage in open areas. The Scallop FMP requirement for industry to pay for observer coverage and the level of set-aside available to help defray the cost of observer coverage are not addressed in Amendment 13. However, they were considered in prior scallop actions, particularly Amendment 10, the action that established the current set-aside program in July 2004. Amendment 13 only implements administrative tools to allow the set-aside to be used; it does not adjust the set-aside program. If this action is implemented, future adjustments to the set-aside program, including adjustments evaluating the commenter's concerns, could be implemented by framework action. No changes to the proposed rule were made as a result of this comment.

The vessels in the scallop fishery could all be considered small business entities because all of them grossed less than $4 million, according to the dealer data, for 2004 to 2006. This action will affect vessels with limited access and general category scallop permits. According to the recent permit data, there were 318 vessels that obtained full-time limited access permits in 2006, including 55 small-dredge and 14 scallop trawl permits. In the same year, there were also 32 part-time and 1 occasional limited access permit in the scallop fishery. In addition, 2,501 permits were issued to vessels in the open access general category and over 500 of these vessels landed scallops during the last 2 years. These numbers could change as the fishing year progresses. There are no large entities participating in this fishery, as defined in section 601 of the RFA. Therefore, there are no disproportionate economic impacts on small entities.

This action does not contain any new collection-of-information, reporting, recordkeeping, or other compliance requirements. It does not duplicate, overlap, or conflict with any other Federal rules. This final rule maintains collection-of-information requirements subject to the Paperwork Reduction Act (PRA), previously approved under control number 0648-0546 in conjunction with the emergency action.

Previous scallop regulatory actions established provisions that impose some cost on vessels that participate in the scallop fishery by requiring vessels to carry and pay for observers on some trips. Compliance costs associated with the observer coverage can be minimized through the set-aside ( i.e. , TAC and DAS, depending on fishing area) that will provide compensation to vessel owners that have paid for observers. This action re-activates the mechanism that allows vessels to offset the costs of observer coverage and harvesting additional scallops from the set-aside. The net impacts of the observer program on vessels that participate in the scallop fishery will depend on scallop prices, trip costs, observer costs, and the TAC or reduced DAS accrual rate provided by NMFS. The analyses presented in Amendment 13 showed that, in some circumstances, observer coverage could reduce crew and vessel income by extending the trip and increasing the trip costs, especially for vessels with a lower catch rate per DAS. But in most cases, overall costs due to the observer coverage will be minimized, and may even yield positive economic benefits, due to the compensation that would be provided by NMFS.

The average total revenue for a general category vessel was $139,755 for the first 11 months of the 2006 fishing year, $249,167 for fishing year 2005, and $260,942 for fishing year 2004. Assuming that the cost of an observer would be $800 per day-at-sea (or $33.30 per hour, slightly higher than the $775 paid by vessels during the 2006 fishing year), average observer costs per general category vessel were estimated to be about $1,440 per trip in 2006. A cost of $1,400 per vessel for the year, assuming that each vessel carries an observer on only one trip, would amount to about 1 percent of total revenue. Similarly, the average total revenue of a limited access vessel was $803,873 for the first 11 months of the 2006 fishing year, $1,072,991 for fishing year 2005, and $988,401 for fishing year 2004. Average observer costs per limited access vessel were $6,560 per trip in 2006. Again, assuming that each vessel carries an observer on only one trip, observer cost would amount to less than 1 percent of the total revenue. (These are the amounts paid to the observer provider and do not include compensation through TAC or DAS set-asides.) Because of the set-aside, compliance costs to scallop vessels are expected to be considerably less than these amounts, under most circumstances. However, as described previously, if there is no set-aside, or no remaining set-aside, to help pay for the observer coverage, the vessels would be responsible for paying the observer, regardless of whether the vessel lands or sells scallops on that trip. This has been the process since the set-aside program was implemented in 1999, but NMFS usually distributes the set-aside such that the majority, if not all trips with an observer aboard, are at least partially compensated.

Economic impacts on scallop vessels, under several scenarios for both limited access and general category vessels, were analyzed in the IRFA for Amendment 13. Scenarios are based on set variables ( i.e., trip costs, cost of observer, and the compensation (either TAC or DAS) provided by NMFS for carrying an observer) and fluctuating variables ( i.e., landings per unit effort, price of scallops). While TAC compensation is provided by NMFS, vessels must incur additional costs to harvest the compensation TAC. Economic impacts on vessels in the scallop fleet are analyzed in the IRFA by considering set variables, fluctuating variables, and whether or not a vessel carries an observer for a trip. Although the IRFA in Amendment 13 analyzes several scenarios, the results are summarized as follows:

For limited access vessels, fluctuating variables in the assumptions include: Landings per unit effort (LPUE) ranging from 1,800 lb (816.5 kg) per DAS to 800 lb (362.9 kg) per DAS and scallop price ranging from $7.60 per lb to $6.00 per lb. Given the highest LPUE and highest price, a vessel's income could be expected to increase by about $9,280 with an observer onboard (from $61,560 without an observer, to $70,840 with an observer). A vessel's crew income could be expected to increase by about $10,722 with an observer (from $63,540 without an observer, to $72,282 with an observer). The increase in income when carrying an observer is due to the compensation for carrying an observer, either additional pounds (400 lb (181.4 kg) per day) or DAS (0.15 reduced accrual rate in open areas). With an LPUE of 800 lb (362.9 kg) per DAS and a price of $7.60 per lb, a vessel's income could be expected to decline by about $32 with an observer onboard (from $24,624 without an observer to $24,592 with an observer). A vessel's crew income could be expected to decline by about $1,619 with an observer (from $19,566 without an observer, to $17,947 with an observer). These decreases in income result from extended trip lengths to catch the additional pounds to pay for an observer.

General category vessels are subject to the industry-funded observer provisions only when fishing in Scallop Access Areas and are compensated with additional pounds per trip. With a compensation of 400 lb (181.4 kg) per day, a vessel would cover observer costs of $1,600 by fishing 2 days and landing 1,200 lb (544.3 kg) of scallops (400 lb (181.4 kg) for the trip and 800 lb (362.9 kg) as compensation). At a price of $6.00 per lb, the vessel would generate $7,200 revenue from scallops, and would increase total crew income by $1,410 and vessel income by $1,440. At a scallop price of $7.60 per lb, vessels and crews could be expected to increase revenues even at a lower compensation rate. By fishing more days, a vessel could experience even more gains in revenue. For example, by fishing 3.5 days and receiving 1,600 lb (725.7 kg) in compensation, total scallop revenue could increase to $15,200 at a price of $7.60 per lb, increasing both crew and vessel income by over $4,000. These positive impacts on vessels are due to the fact that general category vessels are not allowed to land more than 400 lb (181.4 kg) on regular trips and, even at a price of $6.00 per lb, a compensation amount of 400 lb (181.4 kg) could bring $2,400 in revenue, exceeding the cost of the observer and trip costs. However, if compensation pounds were set too low, or if prices decline below $6.00 per lb, the economic gains from compensation for carrying an observer could decline.

Observer coverage would improve information that could be used to reduce the amount of finfish bycatch and the level of sea turtle takes in the scallop fishery. This could eliminate the need for more conservative management measures in the future that may potentially have adverse impacts on the scallop industry. For these reasons and the reasons described above, the benefits of the observer program are expected to exceed costs of this program and have positive economic impacts on vessels participating in the scallop fishery.

The mechanism to allow adjustment of the observer program through framework action could be used to reduce the differential impacts of this program on some vessels, such as by implementing different TAC amounts and DAS accrual rates for smaller vessels. The adjustments through framework could also provide more flexibility to the program in determining the amount of set-aside or the way the observer costs are shared among the vessels in the scallop fleet.

Participation by potential observer service providers is voluntary and, since no Federal action is requiring participation, further assessment of the potential impacts on these entities is not required. No significant quantifiable impacts on scallop prices and change in benefits to the consumers are expected from this action, since the observer program is not expected to impact scallop landings in a significant way.

This action permanently re-activates the industry-funded observer program in the Scallop FMP through a set-aside program that helps vessel owners defray the cost of carrying observers. The alternatives to this action do not provide for an industry-funded observer program. Under the no action alternative, the emergency rule would expire and no regulations would be implemented allowing for funding in addition to that provided by NMFS under its existing observer program. However, as discussed previously, NMFS's current and anticipated funding would only provide for minimal observer coverage in the scallop fishery. Therefore, under the no action alternative, observer coverage levels would likely be less than sufficient for monitoring the yellowtail flounder bycatch TAC in Scallop Access Areas and interactions between the scallop fishery and sea turtles in the Mid-Atlantic during June through October. Due to implications of having minimal observer coverage ( e.g. , earlier closures based on less reliable bycatch estimates), no action would likely result in negative economic impacts ( e.g. , reduced fishing opportunity, reduced harvest) for the scallop industry in both the short and long-term. Without an industry-funded observer program, adequate observer coverage for the scallop fishery could only occur if provided wholly by NMFS. However, because of resource constraints, it is not realistically possible for NMFS to wholly fund an adequate level of observer coverage for the scallop fishery.

The set-aside program is already an established provision in the scallop regulations and the measures in this final rule only establish a mechanism to enable the set-asides to be utilized by the industry as compensation for having paid for observer coverage. Measures to modify and improve the set-aside program are outside the scope of Amendment 13. During the Council's public hearing on Amendment 13 and public comment on the proposed rule, the scallop industry expressed concern that the proposed action would not provide a complete solution to the economic impacts associated with having to pay for observers under the existing set-aside program. The scallop industry also acknowledged that there were no other alternatives, besides the proposed and no action alternatives, that could be considered in Amendment 13. Based on this public input, this action also establishes a mechanism to allow future modifications to the observer program to be implemented by framework action. Providing for a framework mechanism in the Scallop FMP to make adjustments to the observer program would allow more flexibility to address industry's concerns with the program. Because of the administrative nature of this action, there were no other reasonable alternatives.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a small entity compliance guide was prepared. The guide will be sent to all holders of permits issued for the Atlantic scallop fishery. In addition, copies of this final rule and guide ( i.e. , permit holder letter) are available from the Regional Administrator, Northeast Region (see ADDRESSES ).

This final rule maintains collection-of-information requirements subject to the PRA, previously approved under control number 0648-0546 in conjunction with the emergency action. These requirements apply to entities interested in becoming NMFS-approved observer service providers and to those observer service providers approved by NMFS and providing observer services to the scallop fishery. Public reporting burden for these collections of information are estimated to average as follows:

1. Application for approval of observer service provider—10 hr per response;

2. Applicant response to denial of application for approval of observer service provider—10 hr per response;

3. Observer service provider request for observer training—30 min per response;

4. Observer deployment report—10 min per response;

5. Observer availability report—10 min per response;

6. Safety refusal report—30 min per response;

7. Submission of raw observer data—5 min per response;

8. Observer debriefing—2 hr per response;

9. Biological samples—5 min per response;

10. Rebuttal of pending removal from list of approved observer service providers—8 hr per response;

11. Vessel request to observer service provider for procurement of a certified observer—25 min per response; and

12. Vessel request for waiver of observer coverage requirement—5 min per response.

These estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection information. Send comments regarding this burden estimate, or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see ADDRESSES ) and by e-mail 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, and no person shall be subject to 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.

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

The third seasonal allowance of the 2007 halibut bycatch allowance specified for the trawl yellowfin sole fishery category in the BSAI is 49 metric tons as established by the 2007 and 2008 final harvest specifications for groundfish in the BSAI (72 FR 9451, March 2, 2007).

In accordance with § 679.21(e)(7)(v), the Administrator, Alaska Region, NMFS, has determined that the third seasonal allowance of the 2007 halibut bycatch allowance specified for the trawl yellowfin sole fishery category in the BSAI has been reached. Consequently, NMFS is closing directed fishing for yellowfin sole by vessels using trawl gear in the BSAI.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing for yellowfin sole by vessels using trawl gear in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of June 7, 2007.

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

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

NMFS manages the U.S. groundfish fisheries of the Bering Sea and Aleutian Islands Management Area (BSAI) and Gulf of Alaska (GOA) in the Exclusive Economic Zone (EEZ) under the FMPs. The North Pacific Fishery Management Council (Council) has prepared the FMPs pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). Regulations implementing the FMPs appear at 50 CFR part 679. General regulations that pertain to U.S. fisheries appear at subpart H of 50 CFR part 600.

High quality observer data are a cornerstone of Alaska groundfish fisheries management. However, the quality and utility of observer data suffer due to the current structure of procuring and deploying observers. Under the current program, coverage levels vary with the size of the vessel or the quantity of fish processed. Vessel owners and operators choose when and where to carry observers, and fishery managers do not control when and where observers are deployed. To address these concerns, the Council directed NMFS to develop an alternate program structure. Since the early 1990s, the Council and NMFS have explored alternative program structures as part of three separate actions. However, the Council identified problems with each of these actions and none were adopted. While the Council was developing and considering options for an alternate program structure, the Council recommended, and the Secretary approved, several extensions of the Observer Program regulations. A thorough discussion of the need for, and history of, the Observer Program, including past efforts to restructure and extend the Observer Program, is provided in the proposed rule (72 FR 7948, February 22, 2007) and EA/RIR/FRFA prepared for this action (see ADDRESSES ), and is not repeated here.

In October 2002, the Council tasked its observer advisory committee (OAC) to develop a problem statement and alternatives for restructuring the Observer Program. In April 2003, the Council adopted a suite of alternatives that contemplated restructuring the Observer Program in a stepwise approach, beginning in the GOA. However, as NMFS began evaluating these alternatives, it became apparent that certain operational and data quality issues would be difficult to resolve in a revised program under which NMFS contracted directly with observers for observer services in the GOA, but retained the current system for procuring observer services in the BSAI.

From December 2003 through June 2005, the Council refined the suite of alternatives, and in June 2005 adopted the alternatives for analysis. These alternatives include options to restructure the Observer Program for all groundfish and halibut vessels fishing in the GOA only, for halibut vessels and certain sectors fishing in both the GOA and BSAI, and for all groundfish and halibut fisheries. Shoreside and stationary floating processors were included under each alternative depending on their location and management program. In addition to the “no-action” alternative under which the Observer Program would expire, the Council also asked staff to analyze an alternative that would remove the December 31, 2007, expiration date and continue current observer coverage regulations without an expiration date.

While the Council intended to adopt a preferred alternative by January 1, 2008, several issues arose during the course of analysis of the alternatives that has made this difficult. First, due to uncertainty about the applicability of overtime pay provisions of the Fair Labor Standards Act to contracted observers, staff were unable to adequately estimate observer costs under any of the restructuring alternatives. Second, the Research Plan authority to assess a fee for observer coverage could not be exclusively applied to a subset of the North Pacific groundfish fisheries vessels. Therefore, all the action alternatives except Alternative 2 (extension of the current program) required new statutory authorization for fee collection from a portion of the fleet or to implement different fee mechanisms for different sectors, as were considered in the analysis.

Because observer costs could not be adequately estimated and the uncertainty that Congress would authorize fee collection, NMFS recommended that the Council adopt Alternative 2 as its preferred alternative. The Council concurred and adopted Alternative 2 at its February 2006 meeting. The Council also amended the problem statement to reflect that, while Alternative 2 does not address most of the issues in the problem statement, it ensures Observer Program viability, and the continued collection of information necessary to manage the North Pacific fisheries. While the costs of the restructuring alternatives cannot be adequately estimated at this time, the analysis prepared for this action includes restructuring alternatives to provide context to the Council's adoption of Alternative 2.

Expiration of the Observer Program would result in significant costs to groundfish fishery participants. Without data collected by observers, NMFS would be forced to adopt a much more conservative approach towards managing the groundfish fisheries of the GOA and BSAI. Such an approach could lead to early fisheries closures because no observer data would be collected to monitor and estimate groundfish total allowable catch (TAC) and prohibited species catch. NMFS would likely rely more on population models to generate allowable biological catch and TAC recommendations. In addition, failure to maintain a groundfish observer program in the North Pacific would violate the terms of a variety of statutes, including the Endangered Species Act (ESA). The ESA requires observer coverage as a reasonable and prudent measure for certain management actions. These are non-discretionary measures under current biological opinions and are prescribed under the incidental take statements for endangered marine mammals, salmon, and seabirds.

In June 2006 the Council decided it would consider amendments to the FMPs proposing restructuring alternatives for the Observer Program when (1) legislative authority is established for fee-based alternatives; (2) the cost issues described above are clarified (by statute, regulation, or guidance) to allow estimated costs associated with the fee-based alternatives; or (3) the Council responds to changes in conditions that cannot be anticipated now.

On January 12, 2007, the President signed the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act (Public Law 109-479). The reauthorized Magnuson-Stevens Act includes language that appears to allow the Council to adopt a fee collection program as considered in the analysis. However, the exact nature of the fee program authorized by the Magnuson-Stevens Act must be determined, the Council must consider new FMP amendments to restructure the current Observer Program, and NMFS must undergo rulemaking to implement a new Observer Program. Therefore, implementing a fee collection and restructured Observer Program prior to the December 31, 2007, expiration date would be difficult. Additionally, the observer cost issues described above remain unresolved.

For the reasons described above, this action removes the December 31, 2007, expiration date from the section heading of § 679.50 and from regulations at § 679.50(j)(1)(vi). The current Observer Program will continue until the Council recommends and the Secretary approves and implements further action to amend the program. Continuation of the current Observer Program is necessary to prevent interruption of many current management programs.

The proposed rule to extend the Observer Program beyond 2007 was published in the Federal Register on February 22, 2007 (72 FR 7948), and the public review and comment period closed on March 23, 2007. No comments were received during the comment period.

The Administrator, Alaska Region, NMFS, determined that the regulatory amendment is necessary for the conservation and management of the groundfish fisheries off Alaska and that it is consistent with the Magnuson-Stevens Fishery Conservation and Management Act and other applicable laws.

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

An Initial Regulatory Flexibility Analysis (IRFA) was prepared for the proposed rule, and described in the Classification section of the proposed rule. The public comment period ended on March 23, 2007, but no comments were received on the economic analysis in the proposed rule.

NMFS prepared a final regulatory flexibility analysis (FRFA). The FRFA incorporates the IRFA and a summary of the analyses completed to support the action. A copy of this analysis is available from NMFS (see ADDRESSES ). A summary of the analysis follows.

This action would extend the effective date of regulations governing the Observer Program beyond December 31, 2007, the current expiration date. Extending the Observer Program beyond December 31, 2007, is necessary for uninterrupted continuation of many of the current management programs. The entities that would be directly regulated by this action are groundfish harvesters and processors of the BSAI and GOA EEZ. These entities include the groundfish catcher vessels, groundfish catcher processor vessels, and shoreside processors active in these areas. It also includes organizations to which direct allocations of groundfish are made, such as the BSAI Community Development Quota (CDQ) groups and the American Fisheries Act (AFA) fishing sectors.

The FRFA identified the following small entities that would be impacted by this action. Based on 2005 data, 23 of the 87 catcher/processors active in the North Pacific groundfish fisheries are considered small entities. All five North Pacific observer provider companies and the six CDQ groups are considered small entities. Estimates of the number of shoreside processors that are small entities include all Alaska processors that reported processing groundfish to NMFS in 2002. Due to insufficient ownership and affiliation information, it is not possible, at this time, to determine how many of the 73 shoreside processors qualify as small entities. However, at least eight shoreside processors would be considered large entities because of American Fisheries Act (AFA) affiliations. Finally, 807 catcher vessels have gross revenues less than $4 million for groundfish, and would be considered small entities.

In the FRFA, Alternative 1 is the no action alternative. Under this alternative, the current Observer Program would continue to be the only system under which groundfish observers would be provided in the BSAI and GOA groundfish fisheries. Regulations authorizing the current program expire at the end of 2007.

Alternative 2 is the preferred alternative, and would extend the existing program. Under this alternative, the 2007 sunset date for the existing program would be removed and the program would be extended indefinitely with no changes to the overall service delivery model until the Council took further action.

Alternative 3 would restructure the Observer Program for GOA groundfish and all halibut fisheries, while BSAI groundfish fisheries would be administered under the current system. A new ex-vessel value fee program would be established to fund coverage for GOA groundfish vessels, GOA-based processors, and halibut vessels operating throughout Alaska. Regulations that divide the fleet into zero, 30 percent, and 100 percent coverage categories would no longer apply to vessels and processors in the GOA. Fishermen and processors would no longer be responsible for obtaining their own observer coverage. Rather, NMFS would determine when and where to deploy observers based on data collection and monitoring needs, and would contract directly for observers using fee proceeds and/or direct Federal funding.

Alternative 4 would restructure the Observer Program for all fisheries with coverage less than 100 percent. All vessels and processors assigned to Tiers 3 and 4 would participate in the new program throughout Alaska and pay an ex-vessel value based fee. In general, this alternative would apply to all halibut vessels, all groundfish catcher vessels less than 125 ft (38.1 m) length overall and all non-AFA shoreside processors. All vessels and processors assigned to Tiers 1 and 2 (100 percent or greater coverage) would continue to operate under the current “pay-as-you-go” system throughout Alaska.

Alternative 5 would restructure the Observer Program for all groundfish and halibut fisheries off Alaska. This alternative would establish a new fee-based groundfish observer program in which NMFS has a direct contract with observer providers for all GOA and BSAI groundfish and halibut vessels. Under this alternative, vessels with 100 percent or greater coverage requirements would pay a daily observer fee and vessels with coverage requirements less than 100 percent would pay an ex-vessel value based fee.

As noted in the preamble above, Alternative 1 was rejected because it would result in significant costs to the fleet.

The impacts to small entities of the Alternatives 2 through 5, expressed as a percentage of the ex-vessel value of groundfish and halibut landed, are presented in the EA/RIR/FRFA prepared for this action and are summarized here. Current observer costs expressed as a percentage of ex-vessel landed catch value can be considered a reasonable estimate of the costs to each sector of the fleet under Alternative 2 (rollover of the existing program). In the BSAI management area for the years 2000 through 2003, these costs averaged 2.54 percent for catcher/processors, 1.49 percent for catcher vessels, and 0.89 percent for all processors, including motherships. In the GOA management area for these same years, these costs averaged 1.11 percent for catcher/processors, 1.71 percent for catcher vessels, and 0.65 percent for all processors.

Adoption of any of these alternatives as presented in the EA/RIR/FRFA would require selection of a low, middle, or high ex-vessel fee percentage. Estimated costs expressed as a percentage of ex-vessel value of groundfish and halibut landings for the low, middle, and high endpoint options for Alternative 3 are 0.52 percent, 0.70 percent, and 1.05 percent, respectively. Estimated costs in terms of a percent of ex-vessel value for Alternative 4 are 0.69 percent, 0.83 percent, and 1.15 percent. Finally estimated costs in terms of a percent of ex-vessel value for Alternative 5 are 0.69 percent, 0.83 percent, and 1.15 percent. Each of these alternatives was rejected because they would not continue to provide the benefits associated with the Observer Program beyond 2007.

Because of the looming sunset clause contained within the No Action alternative, only Alternative 2 accomplishes the stated objectives, is consistent with applicable statutes, and would minimize the economic impact of the action on small entities. Alternative 2 is the only alternative that achieves the primary objective of this action to extend the Observer Program beyond December 31, 2007.

No additional recordkeeping, reporting, or compliance requirements are associated with this action.