Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on July 24, 2012 (77 FR 43176). That NPRM proposed to correct an unsafe condition for the specified products. The Mandatory Continuing Airworthiness Information (MCAI) states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (77 FR 43176, July 24, 2012) or on the determination of the cost to the public.

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

• Are consistent with the intent that was proposed in the NPRM (77 FR 43176, July 24, 2012) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (77 FR 43176, July 24, 2012).

We estimate that this AD will affect 83 products of U.S. registry. We also estimate that it will take about 2 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $0 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $14,110 or $170 per product.

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

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

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (77 FR 43176, July 24, 2012), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by rescinding AD 2000-07-11 (65 FR 19305, April 11, 2000) that applies to the specified products. That NPRM was published in the Federal Register on July 19, 2012 (77 FR 42454). The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (77 FR 42454, July 19, 2012) or on the determination of the cost to the public.

We reviewed the relevant data and determined that rescinding the AD will not affect air safety and will reduce the burden on the public. We will rescind the AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (77 FR 42454, July 19, 2012) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (77 FR 42454, July 19, 2012).

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

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

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

For the reasons discussed above, I certify this AD:

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

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

(3) Will not affect intrastate aviation in Alaska, and

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

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM published in the Federal Register on August 1, 2012 (77 FR 45513). That NPRM proposed to require, for certain airplanes, repetitive inspections for any discrepancies (such as a gap or a loose spacer) of the aft attach lugs for the elevator tab control mechanism, and replacement if necessary; and, for other airplanes, contacting the FAA for inspection or repair instructions and doing the work specified in those instructions.

We gave the public the opportunity to participate in developing this AD. We have considered the comment received. Boeing supports the NPRM (77 FR 45513, August 1, 2012).

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (77 FR 45513, August 1, 2012) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (77 FR 45513, August 1, 2012).

We estimate that this AD affects 200 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

For Group 1 airplanes, we do not have definitive data that would enable us to provide cost estimates for the action specified in this AD.

We estimate the following costs to do any necessary replacements that would be required based on the results of the inspection. We have no way of determining the number of aircraft that might need these replacements:

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

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

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

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

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

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

(3) Will not affect intrastate aviation in Alaska, and

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

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on May 31, 2012 (77 FR 32060), and proposed to supersede AD 2007-15-06 R1, Amendment 39-16097 (74 FR 62219, November 27, 2009). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We have considered the comments received.

US Airways stated it supports the intent of the NPRM (77 FR 32060, May 31, 2012).

US Airways requested that we postpone the release of the final rule until Airbus revises Airbus A318/A319/A320/A321 ALS Part 5—Fuel Airworthiness Limitations, dated February 28, 2006, as defined in Airbus A318/A319/A320/A321 Fuel Airworthiness Limitations, Document 95A.1931/05, Issue 1, dated December 19, 2005 (approved by EASA on March 14, 2006), Section 1, “Maintenance/Inspection Tasks,” to delete Task 470000-05-1. US Airways stated that, if Task 470000-05-1 is not deleted, the recurring maintenance cost will substantially increase as the air separation module (ASM) will have to be replaced at a cost of $27,000 every 4,000 flight hours.

We disagree with the request to delay release of this AD, since we have determined that an unsafe condition exists and any delay in releasing mitigation actions might not be in the interest of ensuring the safety of the United States fleet. ALS Task 470000-05-1 does not require replacement of the ASM every 4,000 flight hours, although it does require operators to return the ASM to the vendor for a workshop check. Airbus stated in their electronic mail referenced in US Airways' comment that it needs to do some design changes (software change) before it can revise ALS Task 470000-05-1. Therefore, operators may apply for an alternative method of compliance (AMOC) as specified by paragraph (l) of the AD if ALS Task 470000-05-1 is revised in the future.

We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD as proposed, except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (77 FR 32060, May 31, 2012) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (77 FR 32060, May 31, 2012).

We estimate that this AD will affect about 745 products of U.S. registry.

The actions that are required by AD 2007-15-06 R1, Amendment 39-16097 (74 FR 62219, November 27, 2009), and retained in this AD take about 2 work-hours per product, at an average labor rate of $85 per work-hour. Based on these figures, the estimated cost of the currently required actions is $170 per product.

We estimate that it will take about 2 work-hours per product to comply with the new basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $126,650, or $170 per product.

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

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

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (77 FR 32060, May 31, 2012), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

In the final rule modifying equipment and operational requirements for freezer longliners published September 26, 2012, NMFS inadvertently omitted a paragraph in the classification section that addresses OMB Control Number 0648-0269 collection-of-information requirements associated with regulations removed by the final rule.

The final rule removed the regulations at § 679.32(e)(3) that allow CDQ groups to propose to NMFS an alternative fishing plan to use only one observer where two are required, to sort and weigh catch by species on processor vessels, or to use larger sample sizes than those that can be collected by one observer. The final rule standardized the observer coverage and catch monitoring options for longline catcher/processors in both the CDQ and non-CDQ fisheries because the monitoring and enforcement challenges in these fisheries are similar. Because the final rule standardized observer coverage requirements between the CDQ and non-CDQ fisheries, the alternative fishing plan regulations were no longer necessary. All of the language in the regulatory text and preamble text was correct. However, the notice of the removal of the collection-of-information requirements under the Office of Management and Budget control number 0648-0269 was inadvertently omitted from the final rule. This notice corrects that omission.

In rule document 2012-23721 published on September 26, 2012, (77 FR 59053) make the following correction:

1. On page 59059, in column 1, after heading OMB Control No. 0648-0213 and following the paragraph, insert the following heading and text:

This final rule removes collection-of-information requirements subject to the Paperwork Reduction Act (PRA) and which have been approved by the Office of Management and Budget (OMB) under Control Number 0648-0269. The collection-of-information requirement, “alternative fishing plan” and its public reporting burden per response of 4 hours, will be removed from the collection because the alternative fishing plan regulations are no longer necessary.”

On July 30, 2012, we published a Notice of Proposed Rulemaking (NPRM) entitled USCG-2012-0559 in the Federal Register (77 FR 2012-18455). We received no comments on the proposed rule. No public meeting was requested, and none was held.

(a) The legal basis for this rule is the Coast Guard's authority to establish special local regulations pursuant to: 33 U.S.C. 1233.

(b) The purpose of the rule is to provide for the safety of life on navigable waters of the United States during the Ironman 70.3 Miami.

The Coast Guard did not receive any comments to the proposed rule, and no changes were made to the regulatory text.

On October 28, 2012, Miami Tri Events is sponsoring the Ironman 70.3, a triathlon. The swim portion of the event will be held on the waters of Biscayne Bay, Miami, Florida. Approximately 2,500 participants are anticipated to participate in the event. No spectator vessels are expected during the event.

The temporary final rule establishes a special local regulation that will encompass certain waters of Biscayne Bay, Miami, Florida. The special local regulation will be enforced from 6:45 a.m. until 9:45 a.m. on October 28, 2012. The special local regulation will establish an area around the event where all non-participant persons and vessels are prohibited from entering, transiting though, anchoring in, or remaining within. Persons and vessels may request authorization to enter, transit through, anchor in, or remain within the regulated area by contacting the Captain of the Port Miami via telephone at (305) 535-4472, or a designated representative via VHF radio on channel 16. If authorization to enter, transit through, anchor in, or remain within the event area is granted by the Captain of the Port Miami or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Miami or a designated representative. The Coast Guard will provide notice of the special local regulation by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866, or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those orders.

The economic impact of this rule is not significant for the following reasons: (1) The special local regulation will be enforced for only 3 hours; (2) non-participant persons and vessels may enter, transit through, anchor in, or remain within the event area if authorized by the Captain of the Port Miami or a designated representative; (3) non-participant persons and vessels not authorized by the Captain of the Port Miami or designated representative to enter, transit through, anchor in, or remain within the event area may operate in the surrounding area during the enforcement periods; and (4) the Coast Guard will provide advance notification of the special local regulation to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. 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 received no comments from the Small Business Administration on this rule. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule may affect the following entities, some of which may be small entities: the owners or operators of vessels intending to enter, transit through, anchor in, or remain within that portion of the Biscayne Bay encompassed within the special local regulation from 6:45 a.m. until 9:45 a.m. on October 28, 2012. For the reasons discussed in the Regulatory Planning and Review section above, 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 want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT , above.

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 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. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

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 (adjusted for inflation) or more in any one year. Though this rule would 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 would not create an environmental risk to health or risk to safety that might disproportionately affect children.

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

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). Due to potential environmental issues, we conducted an environmental analysis for both the issuance of the marine event permit and the establishment of this special local regulation. After completing the environmental analysis for the issuance of the marine event permit and the establishment of these special local regulations, we have determined these actions will not significantly affect the human environment. This rule is categorically excluded from further review under paragraph 34(h) and 35(b) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES . We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

Table of Acronyms DHS Department of Homeland Security FR  Federal Register NPRM Notice of Proposed Rulemaking A. Regulatory History and Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Coast Guard did not receive necessary information about the event until August 22, 2012. As a result, the Coast Guard did not have sufficient time to publish a NPRM and to receive public comments prior to the event. Any delay in the effective date of this rule would be contrary to the public interest because immediate action is needed to minimize potential danger to the race participants, participant vessels, spectators, and the general public.

For the same reason discussed above, 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 .

The legal basis for the rule is the Coast Guard's authority to establish special local regulations: 33 U.S.C. 1233. The purpose of the rule is to insure safety of life on navigable waters of the United States during the Palm Beach World Championship.

On October 19 and October 21, 2012, Offshore Powerboat Association, Inc. will host the Palm Beach World Championship, a series of high-speed boat races. The event will be held on the waters of the Atlantic Ocean, just offshore of Jupiter, Florida. The high speed power boat race event will include approximately 50 high speed power boat participants and 250 spectator vessels.

The special local regulation encompasses certain waters of the Atlantic Ocean, near Jupiter, Florida. The special local regulation will be enforced daily from 11:00 a.m. until 4:00 p.m. on October 19 and October 21, 2012. The special local regulation will encompass the following two areas: (1) A race area, where all persons and vessels, except those persons and vessels participating or assisting in the high speed power boat race event, are prohibited from entering, transiting through, anchoring in, or remaining within; and (2) a spectator area, where vessels are permitted to anchor. Persons and vessels may request authorization to enter, transit through, anchor in, or remain within the race area by contacting the Captain of the Port Miami via telephone at 305-535-4472, or a designated representative via VHF radio on channel 16. If authorization to enter, transit through, anchor in, or remain within the race area is granted by the Captain of the Port Miami or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Miami or a designated representative. The Coast Guard will provide notice of the special local regulation by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

The economic impact of this rule is not significant for the following reasons: (1) The special local regulation will be enforced for only five hours per day over the course of two days, ten hours total; (2) non-participant persons and vessels may enter, transit through, anchor in, or remain within the race area if authorized by the Captain of the Port Miami or a designated representative; (3) non-participant persons and vessels not able to enter, transit through, anchor in, or remain within the race area may operate in the surrounding area during the enforcement periods; and (4) the Coast Guard will provide advance notification of the special local regulation to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to enter, transit through, anchor in, or remain within that portion of the Atlantic Ocean encompassed within the special local regulation from 11 a.m. until 4 p.m. on October 19, and 11 a.m. until 4 p.m. October 21, 2012. For the reasons discussed in the Regulatory Planning and Review section above, 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 offer to assist small entities in understanding the rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT , above.

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 will not call for a 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 Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

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 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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

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

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

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

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). This rule involves special local regulations issued in conjunction with a marine event. An Environmental Analysis was prepared and addressed both the issuance of the marine event permit and the establishment of the special local regulation. Both the Environmental Analysis and the accompanying Finding Of No Significant Impact (“FONSI”) are available in the docket where indicated under ADDRESSES . We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

On September 21, 2012, we published a temporary deviation entitled “Drawbridge Operation Regulation; Old River, Orwood CA” in the Federal Register (77 FR 58491). The temporary deviation concerned the Burlington Northern & Santa Fe Railroad (BNSF) Drawbridge across Old River, mile 10.4, at Orwood, CA. The deviation was to allow the bridge owner to perform essential mechanical repairs while the bridge remained in the closed-to-navigation position from 8 a.m. October 22, 2012 to 4 p.m. on October 26, 2012. This deviation from the operating regulations was authorized under 33 CFR 117.35.

The temporary deviation is canceled due the unexpected unavailability of an alternative path for navigation during the proposed times and dates of the repair work.

Table of Acronyms CFR Code of Federal Regulations DHS Department of Homeland Security FR  Federal Register U.S.C United States Code A. Regulatory History and Information

On August 10, 2012, we published a notice of proposed rulemaking (NPRM) entitled “Drawbridge Operations; Atlantic Intracoastal Waterway (AIWW), Newport River, Morehead City, NC.” in the Federal Register (77 FR 47787). We received no comments 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 in less than 30 days after publication in the Federal Register . Due to these bridge repairs being required and also being a lengthy process, it is best that this work be done when there is the least marine activity, such as during the winter and night time. Starting the project now will possibly shorten the 2013 summertime impacts to navigation, depending on expected project tempo/efficiency. Also, replacement of the obsolete drive system will allow for a safer/faster way to close the bridge during approaching hurricanes for the 2013 storm season and beyond.

The North Carolina Department of Transportation (NCDOT), who owns and operates this bascule-type railroad bridge, has requested a temporary change to the existing operating regulations to facilitate repairs of existing structural steel, strengthening of the main bascule girders and upgrading the obsolete drive system. The current regulations, under the general requirements set out at 33 CFR 117.5, require that the Carolina Coastal Railroad Bridge, at AIWW mile 203.8, across Newport River in Morehead City NC, shall open promptly and fully for the passage of vessels when a request to open is given. However, the drawbridge is currently maintained in the open to navigation position at all times and closes for passing trains.

In the closed position to vessels, this single-leaf bascule drawbridge has a vertical clearance of 4 feet above mean high water.

To facilitate the required repair work and to minimize the impact on navigation, the drawbridge would operate as follows: (1) From 5 a.m. October 17, 2012 to 8:30 p.m. on October 1, 2013 shall be maintained in the open position to vessels and would only be closed for the passage of trains and to perform periodic maintenance; and (2) in the closed position to vessels, from 8:30 p.m. to 5 a.m., with one optional opening provided at 12 a.m. (midnight) for vessels providing advance notice before 4 p.m. on the afternoon before the requested opening.

Vessel traffic along this part of the Atlantic Intracoastal Waterway consists of commercial and pleasure craft including sail boats, fishing boats, and tug and barge traffic, that transit mainly during the daylight hours with the occasional tug and barge traffic at night. The drawbridge is currently maintained in the open to navigation position at all times and closes for passing trains. Consequently, the number of mariners transiting through this section of the waterway is not based on the amount of vessel openings but on the average number of waterway users, which showed that there are fewer vessel transits at night for mariners, making it a more suitable time to restrict the operation of the drawbridge.

The Coast Guard provided a comment period of 30 days and no comments were received. The Coast Guard would temporarily revise the operating regulations at 33 CFR 117.821 by adding a new paragraph (c). Paragraph (c) would state from 5 a.m. on October 17, 2012 to 8:30 p.m. on October 1, 2013, the draw of the Carolina Coastal Railroad Bridge shall be maintained in the open position to vessels, and would only be closed for the passage of trains and to perform periodic maintenance; and the draw need not open from 8:30 p.m. to 5 a.m., except at 12 a.m. (midnight) for vessels providing advance notice before 4 p.m. on the afternoon before the requested opening.

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

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

The temporary changes are expected to have minimal impact on mariners due to the low number of vessels transiting this area at night. Also, a midnight vessel opening would be available each night for vessels requiring an opening provided that advance notice is given by 4 p.m. on the afternoon before the requested opening.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. 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 received no comments from the Small Business Administration on this rule. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will not have a significant economic impact on a substantial number of small entities because the rule adds navigational restrictions mainly to the movement of vessels during a time when there is less traffic. Most commercial traffic will leave and return during the day. The rule would possibly affect small entities such as owners/operators of vessels due to limited drawbridge openings from 8:30 p.m. to 5 a.m. To minimize delays, these vessels can plan their transits in accordance with the proposed opening schedule.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section, above.

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 Agricultural 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 proposed rule or any policy or action of the Coast Guard.

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on 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. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the “ FOR FURTHER INFORMATION CONTACT ” section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

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 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule would not cause 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 would not create an environmental risk to health or risk to safety that might disproportionately affect children.

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01, and Commandant Instruction M16475.lD which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded under figure 2-1, paragraph (32)(e), of the Instruction.

Under figure 2-1, paragraph (32)(e), of the instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:

On August 10, 2012, we published a NPRM entitled Drawbridge Operation Regulation; Schuylkill River, Philadelphia, PA in the FR (77 FR 47792). We received no comments on the proposed rule. No public meeting was requested, and none was held.

CSX Transportation has requested a change in name and the operation regulation of the Conrail Bridge across Schuylkill River, mile 6.4, at Philadelphia PA. In 1999, CSX acquired the Conrail Bridge but never changed the name. From the time of purchase up to the present day, the Conrail Bridge has been an active and heavily used CSX railroad line. The bridge supports 51 MGT of freight every year. However, over the past 13 years the bridge logs show that there has been no request requiring an opening at the bridge. Therefore, the Coast Guard authorizes the above mentioned bridge to remain in the closed to navigation position in accordance with 33 CFR 117.39.

The vertical clearance of the Swing Bridge is 26 feet above mean high tide in the closed position and unlimited in the open position. The current operating schedule for the bridge is set out in 33 CFR 117.905(e). The current two hour advance notice is no longer necessary because of the lack of openings.

The Coast Guard will revise 33 CFR 117.905(e) for the Conrail Bridge over Schuylkill River, mile 6.4, at Philadelphia, PA. The current regulation states: The draw of the Conrail Bridge, mile 6.4 near Christian Street, Philadelphia, shall open on signal if at least two hours notice is given. The new regulation would change the bridge name to CSX Bridge and allow the bridge to not open for the passage of vessels. The change of the operating regulation will reflect the current use of the waterway and not inhibit those vessels from transiting under the bridge. Pursuant to the NPRM, there was a comment period of 30 days and no comments were received.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. The change is expected to have minimal impact on mariners, because there have been no requests for openings for the past 13 years, and there is no anticipated change to vessel traffic.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. 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 received no comments from the Small Business Administration on this rule. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This final rule would affect the following entities, some of which might be small entities: The owners and operators of vessels intending to transit in that portion of the Schuylkill River that have a mast height of greater than 26 feet. Due to the fact that there have been no requests for openings in 13 years, this final 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 want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT , above.

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 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. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the For Further Information Contact section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

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 (adjusted for inflation) 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 cause 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 might disproportionately affect children.

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

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.

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment because it simply promulgates the operating regulations or procedures for drawbridges. This rule is categorically excluded, under figure 2-1, paragraph (32)(e), of the Instruction.

Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:

Table of Acronyms DHS Department of Homeland Security FR  Federal Register NPRM Notice of Proposed Rulemaking M/V Motor Vessel COTP Captain of the Port MM Mile Marker USACE United States Army Corps of Engineers A. Regulatory History and Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule as publication of an NPRM would be impracticable. The Coast Guard received notification from the USACE on or about July 13, 2012 about necessary bank grading and mat laying operations by the Vicksburg District USACE.

For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Providing a full 30 days notice before the final rule effective date is would be impracticable for the reasons described above. Immediate action implementing this safety zone is needed to protect persons and property from the safety hazards associated with bank grading and mat sinking operations on the Mississippi River.

The legal basis and authorities for this rule are found in 33 U.S.C. 1231, 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish and define regulatory safety zones.

The COTPs Lower Mississippi River and Ohio Valley received notification from the USACE that the USACE will be performing bank grading and mat sinking operations on the Mississippi River. These operations are vital in maintaining a navigable channel for commerce to operate on the river and can only be done during certain times of the year, and under specific water levels and conditions. The fact that the operations are taking place on a highly transited waterway presents hazards to both the waterway traffic and the workers involved in the operations. A fixed and moving safety zone is needed to protect mariners, workers, vessels and other property from the hazards associated with bank grading and mat laying operations. Additionally, a fixed and moving safety zone will assist in timely completion of the USACE operations.

The USACE also requested that the Coast Guard implement a safety zone restricting traffic on the waterway to protect both mariners and persons involved in the operations, specifically the Bank Grading Units, Mat Sinking Unit, and the M/V Harrison and M/V William James and any other operating units. The USACE informed the USCG that during the effective period, USACE operations will require waterway closures lasting approximately one hour at a time when no traffic will be allowed to transit within 500 yards of the operations. Broadcast Notices to Mariners (BNM) and Marine Safety Information Bulletins (MSIBs) can be issued by the Coast Guard to inform marine traffic of these times based on notice provided by the USACE.

The Coast Guard is establishing a temporary fixed and moving safety zone for all waters within 100 yards of the USACE Bank Grading Unit, Mat Sinking Unit, and the M/V Harrison and M/V William James while conducting operations on the Mississippi River. This safety zone is intended to protect persons and property, providing the necessary safety measures affording the USACE to continue with ongoing and timely USACE operations necessary to maintain the commercial channel for the designated areas on the Mississippi River. While these operations are taking place, vessels are required to operate at a minimum safe speed when transiting within all waters encompassing a 100 yard radius around the USACE operating units and vessels are prohibited from transiting into, through, or within a 50 yard radius of the USACE operating units and vessels, unless specifically authorized as explained below. Anchoring, stopping, remaining or drifting without power within the safety zone is prohibited at all times.

Requests to deviate from these restrictions may be made to the applicable COTP and will be considered on a case-by-case basis. The COTP Lower Mississippi River may be contacted by telephone at 866-777-2784. The COTP Ohio Valley may be contacted at 1-800-253-7465. All COTPs can be reached by VHF-FM channel 16. The respective Captain of the Port or a designated representative will inform the public through broadcast notice to mariners of the location of the Bank Grading Units, Mat Sinking Unit and the M/V Harrison and M/V William James effective period for the safety zone and of any changes in the effective period for the safety zone. This rule is effective from August 2, 2012 through 8 a.m. November 1, 2012, local time. If emergency dredging is completed earlier, enforcement of the safety zone will be curtailed.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

This regulation is not a significant regulatory action because it will only be in effect for limited periods of time and will not substantially obstruct maritime traffic. Notifications to the marine community will be made through broadcast notice to mariners and electronic mail. Notices of changes to the safety zone and effective times will also be made. Deviation from the restrictions may be requested from the COTP or designated representative and will be considered on a case-by-case basis. The impacts on routine navigation are expected to be minimal.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. 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.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit the Mississippi River, effective from August 2, 2012 through November 1, 2012, local time. This safety zone will not have a significant economic impact on a substantial number of small entities because this rule allows for the passing of vessels. Traffic in this area is limited to almost entirely recreational vessels and commercial towing vessels. Notifications to the marine community will be made through broadcast notice to mariners and electronic mail. Notices of changes to the safety zone and effective times will also be made. Deviation from the restrictions may be requested from the COTP or designated representative and will be considered on a case-by-case basis.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT , above.

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 will not call for a 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 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. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

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 (adjusted for inflation) 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 cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

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

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

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

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist and a categorical exclusion determination will be made available as indicated under the ADDRESSES section.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

Table of Acronyms DHS Department of Homeland Security FR  Federal Register NPRM Notice of Proposed Rulemaking A. Regulatory History and Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The final details for this event were not known to the Coast Guard until there was insufficient time remaining before the event to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be both impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect vessels from the hazards associated with the demolition project on the Cline Avenue bridge, which are discussed further below.

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 . For the same reasons discussed in the preceding paragraph, waiting for a 30 day notice period to run would be impracticable and contrary to the public interest.

On October 27 and November 10, 2012, Walsh Construction Company will be conducting demolition on portions of the Cline Avenue bridge in East Chicago, IN. The Captain of the Port, Sector Lake Michigan, has determined that this demolition project will pose a significant risk to public safety and property. Such hazards include loss of life and property in the proximity of explosives, and collisions among vessels and contractors involved in the demolition project.

With the aforementioned hazards in mind, the Captain of the Port, Sector Lake Michigan, has determined that this temporary safety zone is necessary to ensure the safety of persons and vessels during the demolition project on the Cline Ave bridge. This zone will be enforced between 6:00 a.m. and 8:00 a.m. on October 27 and November 10, 2012.

The safety zone will encompass all waters of the Indiana Harbor Canal in the vicinity of the Cline Avenue Bridge.

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port, Sector Lake Michigan, or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be small and enforced for only two hours on each day it is in effect. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which might be small entities: the owners or operators of vessels intending to transit or anchor in a portion of Indiana Harbor Canal on October 27 and November 10, 2012.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This safety zone would be activated, and thus subject to enforcement, for only 2 hours on 2 days. Traffic may be allowed to pass through the zone with the permission of the Captain of the Port. The Captain of the Port can be reached via VHF channel 16. Before the activation of the zone, we would issue local Broadcast Notice to Mariners.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

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 will not call for a 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 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. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

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 (adjusted for inflation) 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 cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

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

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

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

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of a safety zone and, therefore it is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES . We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

Table of Acronyms DHS Department of Homeland Security FR  Federal Register NPRM Notice of Proposed Rulemaking A. Regulatory History and Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because any delay encountered in this regulation's effective date by publishing a NPRM would be contrary to public interest. The Coast Guard received information about the event on October 3, 2012. Since immediate action is needed to protect The President of the United States and accompanying high-ranking government officials from potential waterborne threats; the Coast Guard was unable to provide prior notice and opportunity to comment.

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 . The measures contemplated by the rule are intended to protect The President of the United States and accompanying high-ranking government officials, and the public from possible waterborne security threats. Any delay in the effective date of this rule is contrary to public and national interests.

On October 13, 2012, The President of the United States will visit Kingsmill Resort in Williamsburg, VA. The United States Secret Service has requested the Coast Guard provide waterborne point protection during the visit.

This temporary security zone is necessary to provide for the security of The President of the United States and accompanying high-ranking government officials, and protect against sabotage or terrorist attacks to human life, vessels, mariners and waterfront facilities at or near this event.

The U.S. Coast Guard is establishing a temporary security zone on the navigable waters of the James River in the vicinity Kingsmill Resort Marina, Williamsburg, VA. This security zone will encompass all navigable waters on the James River within a 1000 yard radius of approximate position 37°13′23″ N/76°40′03″ W (NAD 1983) in the vicinity of Kingsmill Resort Marina, in Williamsburg, VA.

Access to the security zone will be restricted during the specified date and times. Except for vessels authorized by the Captain of the Port or his Representative, no person or vessel may enter or remain in the regulated area. This temporary security zone will be effective and enforced from 11:59 p.m. on October 12, 2012 to 12:01 p.m. on October 17, 2012.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 or Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. Although this regulation restricts access to the security zone, the effect of this rule will not be significant because: (i) The security zone will be in effect for a limited duration; (ii) the zone is of limited size; (iii) vessels can safely transit around the zone and are not precluded from using any portion of the waterway except the security zone itself; and (iv) the Coast Guard will make notifications via maritime advisories so mariners can adjust their plans accordingly.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. 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. However, this rule may affect the following entities, some of which may be small entities: the owners and operators of vessels intending to transit or anchor in the described portion of the security zone during the enforcement periods from 11:59 p.m. on October 12, 2012 to 12:01 p.m. on October 17, 2012. The temporary security zone will not have a significant impact on a substantial number of small entities because the zone will only be in place for a limited duration and maritime advisories will be issued allowing the mariners to adjust their plans accordingly.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT , above.

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 will not call for a 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 Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INTFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

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 (adjusted for inflation) 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 cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

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

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

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

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule involves establishing a temporary security zone. Under figure 2-1, paragraph (34)(g) of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule because it concerns an emergency situation of less than 1 week in duration.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 subpart C as follows:

On July 31, 2012 (77 FR 45302), EPA proposed approval of amendments to the PSD permitting regulations under West Virginia State Rule 45CSR14, Permits for Construction and Major Modification of Major Stationary Sources of Air Pollution for the Prevention of Significant Deterioration, submitted by the WVDEP as a SIP revision on August 31, 2011. The August 31, 2011 SIP revision submitted by West Virginia generally pertains to two Federal rulemaking actions. The first is the “Implementation of the New Source Review (NSR) Program for Particulate Matter less than 2.5 Micrometers (PM 2.5 )” (NSR PM 2.5 Rule), which was promulgated on May 16, 2008 (73 FR 28321). The second is the “Prevention of Significant Deterioration and Title V Greenhouse Gas Tailoring Rule” (Tailoring Rule), which was promulgated on June 3, 2010 (75 FR 31514). In addition to the August 31, 2011 SIP submission, EPA also proposed to approve those portions of previous SIP submissions from WVDEP which address the PSD-related requirements set forth in CAA section 110(a)(2)(D)(i)(II) for the 1997 PM 2.5 NAAQS, 1997 8-hour ozone NAAQS, 2006 PM 2.5 NAAQS, 2008 lead NAAQS, and 2008 ozone NAAQS, as well as CAA section 110(a)(2)(C) and (J) for the 2008 lead NAAQS and 2008 ozone NAAQS. These previous SIP submissions, submitted by West Virginia to satisfy the PSD-related provisions found in CAA section 110(a)(2) are referred to as infrastructure SIP submissions. All of these State submittals, as well as technical support documents (TSDs) in support of the proposed and final actions are included in the docket. The July 31, 2012 notice of proposed rulemaking (NPR) and its supporting TSD contain detailed discussions of the West Virginia SIP submissions, their relationship to the CAA and the Federal regulatory PSD SIP requirements of 40 CFR part 51.166 applicable as of the time of the August 31, 2011 submittal, as well as the PSD-related infrastructure requirements in CAA section 110(a)(2), and EPA's rationale for its proposed action; therefore, those discussions will not be restated here. A summary of the comments received and EPA's responses are provided in Section II of this document.

EPA received comments on the July 31, 2012 proposal to approve West Virginia's revisions to its SIP's PSD permitting requirements and to approve portions of infrastructure submissions relating to West Virginia's PSD permit program. The portions of the infrastructure submittals at issue relate to the PSD requirements of CAA sections 110(a)(2)(C), (D)(i)(II) and (J) for the 2008 lead NAAQS and the 2008 ozone NAAQS, and CAA sections 110(a)(2)(D)(i)(II) for the 1997 PM 2.5 NAAQS, 1997 ozone NAAQS, and the 2006 PM 2.5 NAAQS. A summary of those comments and EPA's responses are as follows:

Comment: A commenter raises issues regarding the current economy in the State of West Virginia and contends that Federal air pollution requirements imposed since the 1970s have resulted in the economic decline in the Northern Panhandle.

Response: EPA thanks the commenter for the submittal. For purposes of background, EPA is acting on SIP submissions that reflect State law in effect at the time of the submittals. The commenter has not raised any specific issue relating to the proposed approval of West Virginia's SIP submittals at issue in this rulemaking process. Nor has the commenter given any indication of what action they would prefer EPA to take on West Virginia's SIP submittals. Therefore, EPA views this comment as being not relevant to EPA's proposed action and EPA does not have any obligation to respond to this general and unrelated comment. See Sherley v. Sebellius, 776 F. Supp. 2d 1, 53-54 (D.D.C. 2011) (stating Federal agency must only respond to significant comments relevant to an agency's decision); Conference of State Bank Supervisors v. Office of Thrift Supervision, 792 F. Supp. 837, 846 (D.D.C. 1992) (finding agencies need only respond to significant comments under the Administrative Procedure Act).

Comment: EPA cannot approve the infrastructure SIPs because the significant emissions rates in the SIP and other de minimis exceptions are arbitrary and capricious with regard to the 2008 ozone and lead NAAQS.

EPA's Response: EPA disagrees with the commenter that we cannot approve the infrastructure SIPs because the significant emissions rates and other de minimis exceptions are arbitrary and capricious. The purpose of this rulemaking is to take action on West Virginia's SIP revision submittals based upon their consistency with Federal regulations. The significant emissions applicability levels of 0.6 tons per year (TPY) for lead and 40 tons TPY for VOCs and for NO X required by West Virginia's PSD permitting regulations mirror the Federal requirements found at 40 CFR 51.166(b)(23)(i) and 40 CFR 52.21(b)(23)(i). West Virginia's proposed SIP revision satisfies the obligation that its SIP's PSD regulation meet 40 CFR 51.166(b)(23)(i). In fact, West Virginia's regulatory language mirrors the Federal counterpart language. Therefore, EPA has no basis to disapprove West Virginia's regulatory language and require West Virginia to meet an alternative standard which EPA has not established through the required administrative rulemaking process. West Virginia is not required to revise the significant emissions rates in question unless and until EPA revises the Federal requirements at 40 CFR 51.166(b)(23)(i) and 40 CFR 52.21(b)(23)(i). For these reasons, EPA disagrees with the commenter's assertion that the significant emissions applicability thresholds in the West Virginia SIP's PSD regulation are arbitrary and capricious with regard to the 2008 ozone and lead NAAQS.

Comment: One commenter objects to the EPA's proposed approval of the State's infrastructure SIP submissions for the 1997 and 2006 PM 2.5 and the 1997 and 2008 8-hour ozone and the 2008 lead NAAQS on the grounds that “EPA has promulgated increments for PM 2.5 . See 75 FR 64,864 (Oct. 20, 2010). However, the proposed West Virginia SIP does not include these increments even though the increments became applicable on October 12, 2011 * * *. Therefore EPA cannot approve the West Virginia Infrastructure SIP regarding the PSD elements for PM 2.5 .”  1 The commenter argues that “(s)tates are required to include these increments in their SIPs before EPA can fully-approve an infrastructure submission.” However, the commenter also acknowledges that the States had until July 20, 2012 to amend their SIPs to address the PM 2.5 increments required by the requirements of the 2010 PM 2.5 NSR/PSD Rule. With respect to this July 20, 2012 deadline, the commenter asserts that because the proposed rule at issue was published in the Federal Register on July 31, 2012, the proposed rule was published after the deadline by which States were required to submit SIP revisions in compliance with the 2010 PM 2.5 NSR/PSD Rule. Therefore, as of the date that the proposed rule was published in the Federal Register (July 31, 2012), the PM 2.5 increments were required to be included in West Virginia's SIP in order for West Virginia to meet the PSD requirements of sections 110(a)(2)(C), (D)(i)(II) and (J) of the CAA.

In addition to the above assertions, the commenter sets forth three reasons why EPA should not approve the specific CAA 110(a)(2) SIPs without first ensuring that West Virginia's SIP includes the PM 2.5 increments set forth at 40 CFR § 51.166(c): (1) EPA should not allow proposed major sources in West Virginia “to avoid PSD requirements like PM 2.5 increments, while proposed major sources in other states * * * have to comply with this requirement”; (2) because EPA has proposed approval of the PSD requirements of CAA 110(a)(2) for the 2008 ozone and lead NAAQS, EPA will not have another opportunity to “revisit this issue of lack of PM 2.5 increments”; and (3) because emissions of PM 2.5 and its precursors have negative effects on public health and welfare, EPA's full approval of West Virginia's infrastructure SIPs “would cause innocent people to be killed by illegal PM 2.5 emissions.” The commenter concludes by stating that: “EPA must disapprove the PSD elements of the Infrastructure SIPs for failure to include the PM 2.5 increments. In the alternative, EPA could grant a conditional approval if West Virginia agrees to adopt the PM 2.5 increments into its SIP within one year.”

Response: EPA disagrees with the commenter that we cannot approve this SIP submission without inclusion of increments. The commenter asserts that the EPA should now disapprove the West Virginia infrastructure SIP because, since the date of EPA's proposal, the deadline for the submission of a SIP revision addressing the PM 2.5 increments has passed. However, pursuant to the 2010 PM 2.5 NSR/PSD Rule and CAA section 166(b), States were not required to submit a revised SIP addressing the PM 2.5 increments until July 20, 2012. EPA proposed action on the West Virginia infrastructure SIP in a notice signed on July 18, 2012. 2 Therefore, on the date that the proposed rule was signed by the Regional Administrator, the PM 2.5 increments were not required to be included in the West Virginia SIP in order for West Virginia to meet the PSD requirements of CAA sections 110(a)(2)(C), (D)(i)(II) and (J) of the Act. 3

The commenter's concerns relate to the timing of EPA action on collateral, yet related, SIP submissions. These concerns highlight an important overarching question that the EPA has to confront when assessing the various infrastructure SIP submittals addressed in the proposed rule: how to proceed when the timing and sequencing of multiple related SIP submissions impact the ability of the State and the EPA to address certain substantive issues in the infrastructure SIP submission in a reasonable fashion.

It is appropriate for the EPA to take into consideration the timing and sequence of related SIP submissions as part of determining what it is reasonable to expect a State to have addressed in an infrastructure SIP submission for a NAAQS at the time when the EPA acts on such submission. The EPA has historically interpreted section 110(a)(2)(C), section 110(a)(2)(D)(i)(II), and section 110(a)(2)(J) to require the EPA to assess a State's infrastructure SIP submission with respect to the then-applicable and Federally enforceable PSD regulations required to be included in a State's SIP at the time EPA takes action on the SIP. However, the EPA does not consider it reasonable to interpret section 110(a)(2)(C), section 110(a)(2)(D)(i)(II), and section 110(a)(2)(J) to require the EPA to propose to disapprove a State's infrastructure SIP submissions because the State had not yet, at the time of proposal, made a submission that was not yet due for the 2010 PM 2.5 NSR/PSD Rule. To adopt a different approach by which the EPA could not act on an infrastructure SIP, or at least could not approve an infrastructure SIP, whenever there was any impending revision to the SIP required by another collateral rulemaking action would result in regulatory gridlock and make it impracticable or impossible for EPA to act on infrastructure SIPs if EPA is in the process of revising collateral PSD regulations. The EPA believes that such an outcome would be an unreasonable reading of the statutory process for the infrastructure SIPs contemplated in section 110(a)(1) and (2).

The EPA acknowledges that it is important that these additional PSD program revisions be evaluated and approved into the State's SIP in accordance with the CAA. In fact, West Virginia made the submission required by the 2010 PM 2.5 NSR/PSD Rule on June 12, 2010, and the EPA therefore intends to address the PM 2.5 increments in a subsequent rulemaking. EPA also acknowledges the commenter's concern about the potential for sources not being evaluated with respect to increments during the interim period while new PSD program revisions are being evaluated. However, EPA notes that it is implicit in the SIP processing procedures under CAA section 110(k) and the timing of notice and comment rulemaking that there will often be interim periods during which a State has adopted and submitted a new State law requirement in order to meet a CAA requirement, but the EPA will not yet have acted upon it to make it a Federally enforceable part of the State's SIP.

Moreover, major sources in West Virginia are subject to the PM 2.5 increments pursuant to the version of the regulation, 45CSR14, currently in effect in West Virginia. Because the regulations relating to PM 2.5 increments are currently effective and enforceable as a matter of State law, as of June 1, 2012, the EPA in the interim believes that proposed major sources in West Virginia are being required as a matter of State law to comply with the PSD requirements like PM 2.5 increments and thus that these sources are not being treated differently under State law than similar sources in other States that have approved SIP revisions that include the increments. The only distinction between West Virginia and the other States identified by the commenter is that those other States submitted their SIP revisions addressing the PM 2.5 increments far enough in advance of EPA's action on the States' infrastructure SIPs to begin the administrative rulemaking process for such SIP revisions. Thus, the EPA does not believe that approving the State's infrastructure SIP submissions at this time will lead to major sources in West Virginia being treated differently than similar sources in the other States as a factual matter. If the commenter determines that sources are not being evaluated in accordance with applicable State law requirements during the interim before EPA acts on a later SIP submission, those concerns can be addressed in the State's permitting process.

The EPA shares the commenter's concerns that emissions of PM 2.5 and its precursors have negative effects on public health and welfare. However, EPA has no basis on which to find that EPA's approval of West Virginia's infrastructure SIPs “would cause innocent people to be killed by illegal PM 2.5 emissions.” As explained above, the State is addressing PM 2.5 increments in the version of 45CSR14 currently adopted pursuant to State regulatory requirements. West Virginia made the SIP submission required by the 2010 PM 2.5 NSR/PSD Rule to reflect that its PSD permitting program now includes PM 2.5 increments as required by the 2010 PM 2.5 NSR/PSD Rule. EPA will be acting on that submission in a separate rulemaking action in accordance with section 110(k). Until such time as EPA evaluates West Virginia's submission and takes the necessary rulemaking actions, EPA notes the fact that the revisions have been made and are currently enforceable for purposes of State law.

Finally, EPA has considered the suggestion that, rather than approving the State's infrastructure SIPs, the EPA “could grant a conditional approval” of the infrastructure SIPs if West Virginia agrees to adopt the PM 2.5 increments as required by the 2010 PM 2.5 NSR/PSD Rule into its SIP within one year.

The EPA interprets the commenter's suggestion that EPA grant “conditional approval” of the State's infrastructure SIP submissions to be a reference to the concept of conditional approval under section 110(k)(4). The EPA considered the commenter's suggestion as a means of addressing the SIP submission timing issue, but EPA is constrained by the provisions of the statute. Section 110(k)(4), under the rubric of “conditional approval,” explicitly authorizes EPA to approve a SIP submission “based on a commitment of the State to adopt specific enforceable measures by a date certain, but not later than 1 year after the date of approval of the plan revision.” Courts have confirmed that conditional approvals are an available course of action under section 110(k), but only if the statutory conditions for such conditional approvals can be met.

Based on the specific language of section 110(k)(4), EPA concludes that it would not be appropriate to use the mechanism of a conditional approval in this action on the West Virginia PSD-related infrastructure SIP submissions. The statute clearly contemplates use of this approach when a State has made a commitment to make a submission in the future that meets the statutory criteria. In this instance, however, on June 12, 2012, West Virginia submitted the SIP revision required by the 2010 PM 2.5 NSR/PSD Rule. Therefore, the EPA does not believe that it is appropriate to use the mechanism of a conditional approval in these circumstances.

Comment: EPA cannot approve the infrastructure SIPs because West Virginia's SIP does not clearly regulate condensable direct PM 2.5.

Response: The 2008 NSR PM 2.5 Rule changed the Federal definition of “regulated NSR pollutant,” found at 40 CFR 51.166(b)(49)(vi) to require that States account for condensable emissions of particulate matter (condensables) in issuing NSR permits. In light of this comment, EPA is reviewing West Virginia State Rule 45CSR14 to determine the extent to which its definition of “regulated NSR pollutant” satisfies the requirements of section 51.166(b)(49)(vi) insofar as it applies to particulate matter. For this reason, EPA is deferring taking action on the definition of “regulated NSR pollutant” in section 2.66 of West Virginia State Rule 45CSR14 with regard to the requirement to account for condensables. EPA will address this issue in a separate rulemaking action.

EPA is fully approving WVDEP's August 31, 2011 submittal, except for the narrow issue of the requirement to include condensable emissions of particulate matter in the definition of “regulated NSR pollutant” found at 45CSR14 section 2.66. Except for this narrow issue, EPA is approving all other portions of the submittal, including but not limited to, the remainder of section 2.66. In approving West Virginia State Rule 45CSR14 with regard to all other CAA and Federal regulatory SIP requirements for PSD applicable as of the August 31, 2011 SIP revision submission date, EPA is acknowledging that it meets the “Prevention of Significant Deterioration and Title V Greenhouse Gas Tailoring Rule” (Tailoring Rule), which was promulgated on June 3, 2010 (75 FR 31514). EPA is also approving those portions of West Virginia's SIP submissions dated December 3, 2007, December 11, 2007, April 3, 2008, October 1, 2009, October 26, 2011, and February 17, 2012 which address the PSD-related requirements set forth in CAA section 110(a)(2)(D)(i)(II) for the 1997 PM 2.5 NAAQS, 1997 8-hour ozone NAAQS, 2006 PM 2.5 NAAQS, 2008 lead NAAQS, and 2008 ozone NAAQS, as well as CAA section 110(a)(2)(C) and (J) for the 2008 lead NAAQS and 2008 ozone NAAQS, except for the narrow issue of the requirement to include condensable emissions of particulate matter in the definition of “regulated NSR pollutant” found at 45CSR14 section 2.66.

EPA is not finalizing its proposed approval of WVDEP's August 31, 2011 submittal with respect to the narrow issue of the requirement to include condensable emissions of particulate matter in the definition of “regulated NSR pollutant” found at 45CSR14 section 2.66. Additionally, EPA is not finalizing its proposed approval of WVDEP's SIP submissions dated December 3, 2007, December 11, 2007, April 3, 2008, October 1, 2009, October 26, 2011, and February 17, 2012 submitted to meet the PSD-related infrastructure SIP obligations set forth at CAA sections 110(a)(2)(C), (D)(i)(II) and (J) with respect to the narrow issue of the requirement to include condensable emissions of particulate matter in the definition of “regulated NSR pollutant” found at 45CSR14 section 2.66. EPA will address these issues in a separate action.

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by [ Insert date 60 days from date of publication of this document in the Federal Register ]. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action on the West Virginia SIP PSD provisions may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR Part 52 is amended as follows:

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

Table 1 lists the negative declarations we are approving with the dates that they were adopted by the SMAQMD and submitted by the California Air Resources Board (CARB).

On August 16, 2012, EPA determined that the SMAQMD Negative Declarations submitted on July 12, 2012, met the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.

There are no previous versions of these negative declarations.

The negative declarations were submitted to meet the requirements of CAA section 182(b)(2). Ozone nonattainment areas classified at moderate and above are required to adopt VOC regulations for the published Control Techniques Guidelines (CTG) categories and for major non-CTG sources of VOC or NO X . If a nonattainment area does not have stationary sources covered by an EPA published CTG, then the area is required to submit a negative declaration. The negative declarations were submitted because there are no applicable sources within the SMAQMD jurisdiction. EPA's technical support document (TSD) has more information about these negative declarations.

The negative declarations are submitted as SIP revisions and must be consistent with CAA requirements for Reasonably Available Control Technology (RACT) (see section 182(b)(2)) and SIP relaxation (see sections 110(1) and 193.) To do so, the submittal should provide reasonable assurance that no sources subject to the CTG requirements currently exist or are planned for the SMAQMD.

We believe these negative declarations are consistent with the relevant policy and guidance regarding RACT and SIP relaxations. The TSD has more information on our evaluation.

As authorized in section 110(k)(3) of the Act, EPA is fully approving the submitted negative declarations as additional information to the SIP because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register , we are simultaneously proposing approval of these negative declarations. If we receive adverse comments by November 16, 2012, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on December 17, 2012.

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

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

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

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

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

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

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

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

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

• Does not interfere with Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) because EPA lacks the discretionary authority to address environmental justice in this rulemaking.

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 17, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the Proposed Rules section of today's Federal Register , rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

Part 52, Chapter I, Title 40 of the Code of Federal

Regulations is amended as follows:

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).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather 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 .

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2011-0759 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 17, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

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. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0759, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.htm. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of November 9, 2011 (76 FR 69690) (FRL-9325-1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petition (PP) 1E7908 by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540, and PP 1F7905 by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, Wilmington, DE. The petitions requested that 40 CFR 180.511 be amended by establishing tolerances for residues of the insecticide buprofezin (2-[(1,1-dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-phenyl-4 H -1,3,5-thiadiazin-4-one) in or on bean, succulent at 0.02 parts per million (ppm); Brassica, leafy greens, subgroup 5B at 55 ppm; turnip, greens at 55 ppm; vegetable, fruiting, group 8-10 at 3.0 ppm; fruit, citrus, group 10-10 at 2.5 ppm; fruit, pome, group 11-10 at 4.0 ppm; persimmon at 1.9 ppm; and tea at 20 ppm (PP 1E7908) and PP 1F7905 requested tolerances for residues in or on nut, tree, group 14 at 0.05 ppm and pistachios at 0.05 ppm. PP 1E7908 also requested removal of tolerances for non-bell pepper; fruiting vegetable group 8, except non-bell pepper; fruit, citrus, group 10; and fruit, pome, group 11 which will be covered by the newly requested tolerances. That notice referenced a summary of the petition prepared by Nichino America, Inc., the registrant, which is available in the docket, http://www.regulations.gov. Two general comments were received on the notice of filings. EPA's response to these comments is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA has revised the proposed tolerance levels for several commodities. Due to insufficient data, EPA is not establishing the citrus group 10-10 tolerance. The reasons for these changes are explained in Unit IV.D.

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

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for buprofezin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with buprofezin 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.

Buprofezin has low acute toxicity via the oral, dermal and inhalation routes of exposure. It is not an eye or skin irritant; nor is it a dermal sensitizer. In subchronic toxicity studies, the primary effects of concern in the rat were increased microscopic lesions in male and female liver and thyroid, increased liver weights in males and females, and increased thyroid weight in males. In chronic studies in the rat, an increased incidence of follicular cell hyperplasia and hypertrophy in the thyroid of males was reported. Increased relative liver weights were reported in female dogs. Buprofezin was not carcinogenic to male and female rats. In the mouse, increased absolute liver weights in males and females, along with an increased incidence of hepatocellular adenomas and hepatocellular adenomas plus carcinomas in females were reported. The increase in carcinomas was not statistically significant when analyzed separately. Based on the increased incidence of combined benign and malignant liver tumors in female mice only, no evidence of carcinogenicity in rats, and no evidence of genotoxicity in submitted guideline studies using in vitro and in vivo genotoxicity assays, EPA classified buprofezin as having no greater than suggestive evidence of carcinogenicity.

Developmental and reproductive toxicity studies do not indicate concern for increased susceptibility in offspring. Toxicity in the offspring was found at dose levels that were also toxic to the parent and the effects observed in the offspring were not more severe, qualitatively, than the effects observed in the parent. No neurotoxic effects were observed at any dose in a subchronic neurotoxicity study in rats at the highest dietary doses of 5,000 ppm. An immunotoxicity study did not demonstrate immunotoxic effects by buprofezin. A special study is required to generate specific data on the thyroid to protect the developing nervous system from thyroid hormone disrupting chemicals.

Specific information on the studies received and the nature of the adverse effects caused by buprofezin 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 in the document “Buprofezin Human Health Risk Assessment for Proposed Use of Buprofezin on Tree Nut Crop Group 14 including Pistachio, Brassica Leafy Greens Subgroup 5B, Turnip Greens, Tea and Persimmon & Expanded Uses on Fruiting Vegetables, Succulent Beans, Citrus Fruit, and Pome Fruit,” pp. 40—42 in docket ID number EPA-HQ-OPP-2011-0759.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. 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/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for buprofezin used for human risk assessment is shown in the Table of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to buprofezin, EPA considered exposure under the petitioned-for tolerances as well as all existing buprofezin tolerances in 40 CFR 180.511. EPA assessed dietary exposures from buprofezin in food as follows:

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

Such effects were identified for buprofezin in the population subgroup females age 13-49. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed tolerance level residues for buprofezin and estimated residue levels of the BF4 Conjugate, a metabolite of concern, based on buprofezin metabolism data. The BF4 Conjugate is not detectable by data collection methods and thus is not included in the tolerance level. Given the potential for the buprofezin metabolites BF9 and BF12 to concentrate to a greater degree than buprofezin in processed commodities, Dietary Exposure Evaluation Model (DEEM) (Version 7.81) default processing factors were retained for all commodities, except for tomato paste and puree, which were reduced based on empirical data. Total residues of concern in meat and milk were based on feeding study data. EPA also assumed 100 percent crop treated (PCT) for all commodities.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. A refined chronic dietary analysis was conducted using PCT estimates when available and 100 PCT for all other crops. Buprofezin residues in crop commodities were estimated based on average residue levels from field trial data, average residue levels from USDA Pesticide Data Program (PDP) data, or tolerance level residues. As with the acute exposure assessment, EPA estimated residue levels of the metabolite BF4 Conjugate were based on metabolism data. Given the potential for the buprofezin metabolites BF9 and BF12 to concentrate to a greater degree than buprofezin in processed commodities, DEEM (Version 7.81) default processing factors were retained for all commodities, except for tomato paste and puree, which were reduced based on empirical data. Total residues of concern in meat and milk were based on feeding study data.

iii. Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. Cancer risk is quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or nonlinear approach is used and a cancer RfD is calculated based on an earlier noncancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to buprofezin and the cRfD would be protective of cancer effects.

The cRfD was based on an endpoint of toxicity from a rat combined chronic/oncogenicity study. The NOAEL in this study was 1.0 mg/kg/day based on increased incidence of follicular cell hyperplasia and hypertrophy in the thyroid of males at 8.7 mg/kg/day. Buprofezin was not carcinogenic in rats. Administration of buprofezin in the diet was associated with increased incidence of liver tumors in female mice only at the mid- and high-doses but not at the low dose of 1.82 mg/kg/day which was considered to be the NOAEL for the females. Because the positive evidence of cancer was limited to one sex of one species (female mice), there was no evidence of mutagenicity, and no carcinogenic effects in rats, EPA concluded that the weight-of-the-evidence indicated that the carcinogenic findings in female mice are a threshold effect. The NOAEL of 1 mg/kg/day from the rat study on which the cRfD is based on is lower than the NOAEL for liver tumors of 1.82 mg/kg/day from the mouse. Therefore, the cRfD would be protective of potential carcinogenic effects from exposure to buprofezin.

iv. Anticipated residue and PCT information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) 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 FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

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

• Condition 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 the pesticide residue.

• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition 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 FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The Agency estimated the PCT for existing uses as follows:

Almond 1%; Cantaloupes 5%; Cotton 1%; Grapefruit 1%; Honeydew 2.5%: Lemons 2.5%; Lettuce (head and leaf) 1%; Oranges 2.5%; Pears 15%; Pistachio 5%; Pumpkins 1%; Squash (summer) 1%; Tomatoes 2.5%; Watermelons 2.5%.

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 Pesticide Use Database for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.

Buprofezin has only been registered for use on some commodities since late 2009. Therefore, PCT estimates based on actual usage data were not deemed sufficient indicators of potential usage on these recently registered crops. In 2009 the EPA used PCT estimates for these commodities based on the market leader approach and has determined these are still appropriate estimates to be used in risk assessment. The Agency estimated the PCT for the uses registered in 2009 as follows:

Spinach 30%; Celery 18%; Broccoli 55%; Cabbage 40%, Celery 18%, Chinese Broccoli 55%; Brussel Sprouts 61%; Cauliflower 48%; Kohlrabi 5%; Apple 5%; Apricot 51%; Cherry 72%; Nectarine 51%; Peach 13%; Plum 37%; Grape 15%; Strawberry 39%;

For additional information regarding the PCT estimates for these commodities refer to the final rule published in the Federal Register of July 10, 2009 (74 FR 33153) (FRL-8421-3).

The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, 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 b and c, 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 reliable information on the regional consumption of food to which buprofezin may be applied in a particular area.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for buprofezin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of buprofezin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of buprofezin for acute exposures are estimated to be 58.2 parts per billion (ppb) for surface water and 0.09 ppb for ground water. The EDWCs for chronic exposures are estimated to be 18.6 ppb for surface water and 0.09 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 58.2 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration value of 18.6 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Buprofezin is not registered for any specific use patterns that would result in residential exposure.

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

EPA has not found buprofezin to share a common mechanism of toxicity with any other substances, and buprofezin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that buprofezin does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10x) 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 database 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 (SF). In applying this provision, EPA either retains the default value of 10x, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There is no evidence of increased quantitative or qualitative susceptibility following in utero (rats and rabbits) and pre-and post-natal exposure (rats) to buprofezin.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1x for acute exposures. However, the 10x FQPA safety factor has been retained for chronic exposure. These decisions are based on the following findings:

i. The toxicity database for buprofezin is complete except for submission of the thyroid toxicity study that will inform the Agency's understanding of buprofezin's chronic effects. A chronic POD of 1.0 mg/kg/day (NOAEL) was selected for the general population from a 2-year chronic feeding study in rats based on increased incidence of follicular cell hyperplasia and hypertrophy in the thyroid in males at the LOAEL of 8.7 mg/kg/day. A UF 300× (10× for intraspecies variation; 3× for interspecies extrapolation—reduced from 10× based on demonstrated evidence that rats are more susceptible to thyroid effects than humans; 10× for protection of infants and children) was applied to the dose to obtain a cPAD. The 10× FQPA Safety Factor was retained due to uncertainty caused by the lack of a thyroid assay in young rats. In rat chronic, subchronic, and reproductive toxicity studies effects such as thyroid enlargement and follicular cell hyperplasia were seen in adult animals. However, hormone levels, thyroid organ weights, and histopathology were not evaluated for pups in any reproductive studies. To assess the potential toxic characteristics to thyroid structure or hormone homeostasis during development, the Agency is requiring a developmental thyroid study.

ii. There is no indication that buprofezin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that buprofezin results in increased susceptibility to in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The acute dietary food exposure assessment was performed based on 100 PCT and a conservative estimate of total residues of concern for buprofezin. The chronic dietary food exposure assessment was performed based, in part on, average field trial residues, average USDA PDP residues, and PCT were used where available. Nonetheless, the chronic exposure assessment is conservative and is likely to overestimate risks based on a number of factors including, use of 100 PCT assumptions for several crops for which data were unavailable, use of a conservative factor to account for the BF4 Conjugate, use of default processing factors, and use of drinking water exposure estimates for application of buprofezin to coffee, which is grown in limited areas of the U.S. (e.g., Puerto Rico, Hawaii). Likewise, EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to buprofezin in drinking water. These assessments will not underestimate the exposure and risks posed by buprofezin.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to buprofezin will occupy 5% of the aPAD for females 13-49 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to buprofezin from food and water will utilize 91% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for buprofezin.

3. Short and intermediate-term risk. Short and intermediate-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). A short and intermediate-term adverse effect was identified; however, buprofezin is not registered for any use patterns that would result in short-term residential exposure. Short and intermediate-term risk is assessed based on short and intermediate-term residential exposures plus chronic dietary exposure. Because there is no short and intermediate-term residential exposures and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short and intermediate-term risk), no further assessment of short and intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short and intermediate-term risk for buprofezin.

4. Aggregate cancer risk for U.S. population. The Agency considers the chronic aggregate risk assessment, making use of the cPAD, to be protective of any aggregate cancer risk. Based on the limited evidence of carcinogenicity (driven by benign liver tumors) of buprofezin to female mice only and not males or rats, and no mutagenicity, EPA concluded a threshold approach is appropriate for the risk assessment. Therefore, the chronic assessment is considered protective for the cancer risk estimate.

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 buprofezin residues.

Adequate gas chromatography with nitrogen phosphorus detection (GC/NPD) and a GC/mass spectrometry (MS) method for confirmation of buprofezin residues in plant commodities is available to enforce the tolerance. These methods are available in the Pesticide Analytical Manual (PAM) Volumes I & II for enforcement of buprofezin tolerances.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The tolerance level being established by this action for tree nut group 14 is harmonized with the Codex MRL for almond. There is an established Codex MRL of 2.0 ppm in/on pepper and 1.0 ppm in/on tomato. The petitioner proposed a tolerance of 3.0 ppm for the Fruiting vegetable group 8-10, which contains both peppers and tomatoes. EPA cannot harmonize the U.S. tolerance on tomatoes with the tomato MRL because the residue field trial data submitted to support the fruiting vegetable group 8-10 tolerance reported residues higher than the 1.0 ppm level established by Codex for tomato. However, the residue field trial data was consistent with a tolerance of 2.0 ppm for the fruiting vegetable group 8-10, so EPA was able to harmonize with the Codex MRL for peppers. For pome fruit, the Codex MRLs and the U.S. tolerances are harmonized for “fruit, pome (except pear and pear, Asian) at 3.0 ppm and pear and pear, Asian at 6.0 ppm. There are currently no established Codex MRLs for buprofezin in/on the remainder of the tolerances being established.

EPA received two comments to the notice of filings PP 1E7908 and 1F7905, which said that toxic chemicals should not be allowed on food that Americans eat. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. This citizen's comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework.

The tolerance for fruit, citrus, group 10-10 is not being established at this time due to a lack of residue chemistry data. Based on the data supporting the petition, EPA has revised the proposed tolerance on Brassica, leafy greens, subgroup 5B and turnip greens from 55 ppm to 60 ppm. The Agency revised these tolerance levels based on analysis of the residue field trial data using the Organization for Economic Co-operation and Development (OECD) tolerance calculation procedures.

Additionally, the Agency revised the proposed tolerance in or on vegetables, fruiting, group 8-10 from 3.0 to 2.0 to harmonize with the Codex MRL on pepper and will establish separate tolerances for fruit, pome, group 11-10 (except pear and pear, Asian) at 3.0 ppm and pear and pear, Asian oriental at 6.0 ppm to harmonize with Codex. A tolerance is not needed for pistachio since there is already a pistachio tolerance in § 180.511. Finally, the Agency is correcting language for established commodities that are spelled incorrectly—Llama should be Ilama and Loganberry should be Logan.

Therefore, tolerances are established for residues of buprofezin 2-[(1,1-dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-phenyl-4 H -1,3,5-thiadiazin-4-one, in or on bean, succulent at 0.02 ppm; Brassica, leafy greens, subgroup 5B at 60 ppm; fruit, pome, group 11-10 (except pear and pear, Asian) at 3.0 ppm; nut, tree, group 14 at 0.05 ppm; pear at 6.0 ppm; pear, Asian at 6.0 ppm; persimmon at 1.9 ppm; tea at 20 ppm; Turnip, greens at 60 ppm; vegetable, fruiting, group 8-10 at 2.0 ppm. Additionally, this regulation removes tolerances of buprofezin in or on almond at 0.05 ppm, fruit, pome group 11 at 4.0 ppm, okra at 4.0 ppm, nonbell pepper at 4.0 ppm and vegetable, fruiting group 8, except nonbell pepper at 1.3 ppm as they will be superseded by the tolerances being established with this action.

This final rule establishes tolerances under FFDCA section 408(d) 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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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 9, 2000) do not apply to this final rule. In addition, this final 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).

Therefore, 40 CFR chapter I is amended as follows:

I. Background and Summary of Errors

In the FY 2013 Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System final rule (hereinafter referred to as the FY 2013 IPPS/LTCH PPS final rule) (FR Doc. 2012-19079 of August 31, 2012 (77 FR 53258)), there were several typographical and technical errors in the regulations text that are identified and corrected in this correcting amendment. The provisions in this correcting amendment apply to long-term care hospital (LTCH) prospective payment system (PPS) payments.

In finalizing the regulations text changes for the FY 2013 LTCH PPS provisions (77 FR 53680), we made the following errors:

• In § 412.534(h)(6), we inadvertently omitted regulations text that specified our methodology for determining the percentage of discharges during a LTCH's or satellite facility's cost reporting period beginning on or after July 1, 2012 and before October 1, 2012 that will not be counted towards the 25-percent threshold during such cost reporting period.

• In § 412.536(a)(3)(i)—

++ We inadvertently omitted regulations text that specified the discharges to which the 25-percent payment adjustment threshold policy applies for LTCHs with cost reporting periods beginning on or after July 1, 2012 and before October 1, 2012; and

++ We made an error in the timeframe during which the 25-percent payment adjustment threshold policy will not apply for certain LTCHs (that is, those LTCHs with a cost reporting period beginning on or after July 1, 2012 and before October 1, 2012).

• In § 412.536(a)(3)(ii), we made an error in citing the timeframe during which the 25-percent payment adjustment threshold policy is in effect for certain LTCHs (that is, those LTCHs with a cost reporting period beginning on or after July 1, 2012 and before October 1, 2012), as well as an error in the timeframe during which discharges occurring during such LTCHs' cost reporting periods will not be counted towards the 25-percent threshold.

We ordinarily publish a notice of proposed rulemaking in the Federal Register to provide a period for public comment before the provisions of a rule take effect in accordance with section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). However, we can waive this notice and comment procedure if the Secretary finds, for good cause, that the notice and comment process is impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and the reasons therefore in the notice.

Section 553(d) of the APA ordinarily requires a 30-day delay in effective date of final rules after the date of their publication in the Federal Register . This 30-day delay in effective date can be waived, however, if an agency finds for good cause that the delay is impracticable, unnecessary, or contrary to the public interest, and the agency incorporates a statement of the findings and its reasons in the rule issued.

We find that there is good cause to waive both the notice and comment and delayed effective date requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the final rule or delaying the effective date would be contrary to the public interest. We believe it is in the public interest for our regulation text to accurately reflect the policy on the 25-percent payment adjustment threshold which was adopted in the FY 2013 IPPS/LTCH PPS final rule. Therefore delaying the effective date of these corrections would be contrary to the public interest. Furthermore, such procedures would be unnecessary, as we are not altering the policies that were already subject to comment and finalized in the FY 2013 IPPS/LTCH PPS final rule. As indicated previously, this correcting amendment corrects technical and typographical errors in the regulations text of the FY 2013 IPPS/LTCH PPS final rule and does not make substantive changes to the policies or payment methodologies that were adopted in the final rule. As a result, this correcting amendment is intended to ensure that the regulations text accurately reflects the policies adopted in the FY 2013 IPPS/LTCH PPS final rule. Therefore, for the reasons set forth previously, we believe we have good cause to waive the notice and comment and effective date requirements.

As noted in section I. of this correcting amendment, the Centers for Medicare & Medicaid Services is making the following correcting amendments to 42 CFR part 412:

The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR Part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the Federal Register .

In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR Part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

Accordingly, 44 CFR Part 64 is amended as follows:

This document announces that, on September 17, 2012, OMB approved, for a period that expires on September 30, 2015, the information collection requirements contained in the Commission's Order, FCC 12-22, regarding Interconnected Voice over Internet Protocol (VoIP) outage reporting rules, published at 77 FR, 25088, April 27, 2012.

As required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3507), the Commission is notifying the public that it received OMB approval on September 17, 2012, for the information collection requirements contained in the modifications to the Commission's rules in 47 CFR Part 4. OMB approved the Order under the PRA Submission, Form OMB 83i, dated July 24, 2012, titled Section 4.1 and 4.2 and Part 4 of the Commission's rules Concerning Disruptions to Communications. Under 5 CFR 1320, an agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. The OMB control number is 3060-0484. The foregoing notice is required by the Paperwork Reduction Act of 1995, Pub. L. 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-0484.

OMB Approval Date: September 17, 2012.

Expiration Date: September 30, 2015.

Title: Extension of the Commission's Rules Regarding Outage Reporting to Interconnected Voice over Internet Protocol Service Providers and Broadband Internet Service Providers

Form Number: N/A.

Estimated Time per Response: 1.25 to 2 hours.

Total Annual Burden: 29,647 hours.

Total Annual Cost: N/A.

Obligation to Respond: The number of respondents/responses is 118 respondents 15,444 responses. The statutory authority for this information collection is contained in 47 U.S.C. 151, 152, 154(i)-(k), 154(o), 218, 219, 230, 256, 301, 302(a), 303(f), 303(g), 303(j), 303(r), 403, 615a-l, 621(b)(3), 621(d), 1302(a) and 1302(b) of the Communications Act of 1934, as amended; and section 1704 of the Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1998, 44 U.S.C. 3504.

Nature and Extent of Confidentiality: Outage reports filed pursuant to part 4 of the Commission's rules are presumed confidential. The information in the filings may be shared with the Department of Homeland Security only under appropriate confidential disclosure provisions. Other persons seeking disclosure must follow the procedures delineated in 47 CFR 0.457 and 0.459 of the Commission's rules for requests for and disclosure of information.

Privacy Act: No impact(s).

Needs and Uses: The Commission extended mandatory outage reporting rules to facilities-based and non-facilities-based interconnected VoIP service providers and applied the current Part 4 definition of “outage” to outages of interconnected VoIP service, covering the complete loss of service and/or connectivity to customers at least 30 minutes duration that potentially affects at least 900,000 user minutes of interconnected VoIP services and results in complete loss of service; or potentially affects any special offices and facilities such as a 911 facility. Collecting data on significant outages of interconnected VoIP services will help the Commission to monitor compliance with the statutory 911 obligations of interconnected VoIP service providers, as well as help ensure the Nation's current and future 911 systems are as reliable and resilient as possible both on a day-to-day basis and in times of a major emergency. The Commission recognizes that consumers are increasingly relying on Internet Protocol (IP)-based technologies as substitutes for communications services provided by older communications technologies, and increasingly use interconnected VoIP services in lieu of traditional telephone service. As of December 31, 2010, 31 percent of the more than 87 million residential telephone subscriptions in the United States were users of interconnected VoIP providers—an increase of 21 percent (from 22.4 million to 27.1 million) from the end of 2009. Additionally, the Commission estimates that approximately 31 percent of residential wireline 911 calls are made using VoIP service. The information collected is administered by the FCC's Public Safety and Homeland Security Bureau (PSHSB) which maintains an Internet Web site portal for the electronic submission of the required outage reports. In addition, provision is made for the submission of required data by other than electronic means in cases where electronic submission is not feasible.

First, Respondents must submit electronically via the Network Outage Reporting System (NORS) (See http://transition.fcc.gov/pshsb/services/cip/nors/nors.html ) notification to the Federal Communications Commission within: (a) 240 minutes of discovering that they have experienced on any facilities that they own, operate, lease, or otherwise utilize, an outage of at least 30 minutes duration that potentially affects a 9-1-1 special facility, in which case they also shall notify, as soon as possible by telephone or other electronic means, any official who has been designated by the management of the affected 9-1-1 facility as the provider's contact person for communications outages at that facility; in this case, the provider shall convey to that person all available information that may be useful to the management of the affected facility in mitigating the effects of the outage on efforts to communicate with that facility; or (b) 24 hours of discovering that these providers have experienced on any facilities that they own, operate, lease, or otherwise utilize, an outage of at least 30 minutes duration that: Potentially affects at least 900,000 user minutes of interconnected VoIP service and results in complete loss of service; or potentially affects any special offices and facilities. Second, Respondents must submit electronically via NORS a Final Communications Outage Report to the Commission not later than thirty days after discovering the outage.

Electronic Access

This final rule is accessible via the Internet at the Office of the Federal Register's Web site at http://www.gpo.gov/fdsys/search/home.action. Background information and documents are available at the Pacific Fishery Management Council's Web site at http://www.pcouncil.org/.

The Pacific Coast Groundfish FMP and its implementing regulations at title 50 in the Code of Federal Regulations (CFR), part 660, subparts C through G, regulate fishing for over 90 species of groundfish off the coasts of Washington, Oregon, and California. Groundfish specifications and management measures are developed by the Pacific Fishery Management Council (Council), and are implemented by NMFS. On November 3, 2010, NMFS published a proposed rule to implement the 2011-2012 harvest specifications and management measures for most species of the Pacific Coast groundfish fishery (75 FR 67810). The final rule to implement the 2011-12 harvest specifications and management measures for most species of the Pacific Coast Groundfish Fishery was published on May 11, 2011 (76 FR 27508). This final rule was subsequently amended by several inseason actions (76 FR 39313, 76 FR 67092, 76 FR 79122, 77 FR 12503, 77 FR 22679, 77 FR 24634, 77 FR 47322). On September 27, 2011, NMFS published a proposed rule to implement final 2012 specifications for overfished species and assessed flatfish species pursuant to Secretarial Amendment 1 to the Groundfish FMP (76 FR 59634). That final rule was effective January 1, 2012.

The Council, in consultation with Pacific Coast Treaty Indian Tribes and the States of Washington, Oregon, and California, recommended the changes to current groundfish management measures implemented by this action at its September 12-September 17, 2012 meeting. The Council recommended adjusting groundfish management measures for the remainder of the biennial period to respond to updated fishery information and additional inseason management needs. The adjustments to fishery management measures are not expected to result in greater impacts to overfished species than originally projected through the end of 2012. Estimated mortality of overfished and target species is the result of management measures designed to achieve, to the extent possible, but not exceed, annual catch limits (ACLs) of target species while fostering the rebuilding of overfished stocks by remaining within their rebuilding ACLs.

To ensure harvest opportunities for the OA fixed gear sablefish DTL fishery, and that its harvest guideline south of 36° N. lat. is further attained, the Council considered increases to trip limits for sablefish in this fishery and the potential impacts on overall catch levels. The Council's Groundfish Management Team (GMT) made model-based landings projections of the OA fixed gear sablefish DTL fishery south of 36° N. lat. for the remainder of 2012. These projections were based on the most recent information available under the current 2012 trip limit scenario, and predicted a harvest projection of 41 percent (126 mt) of this fishery's harvest guideline (309 mt) under the status quo trip limits. Landings projections with the proposed increased trip limits predict a harvest of 52 percent (161 mt) of this fishery's harvest guideline. Projections for the other three fixed gear sablefish fisheries were tracking within their targets for 2012.

Therefore, the Council recommended and NMFS is implementing trip limit changes for the OA fixed gear sablefish DTL fishery south of 36° N. lat. that increase OA fixed gear sablefish DTL fishery limits from “300 lb per day (136 kg), or one landing per week of up to 1,350 lb (612 kg), not to exceed 2,700 lb (1225 kg) per two months” to “350 lb (159 kg) per day, or one landing per week of up to 1,750 lb (794 kg), not to exceed 3,500 lb (1,588 kg) per 2 months” beginning in period 6, November 1, 2012 through the end of the year.

Due to uncertainty in the catch estimates, and to reduce the potential for cowcod mortality to exceed the non-trawl allocation in 2012, the Council considered modifications to the current SMA RCA boundary. Recreational fishing for most groundfish is currently prohibited seaward of a boundary line approximating the 60 fathom depth (110 meters) contour in California south of 34°27′ N. lat. The new boundary would expand the closed area, restricting fishing to the area seaward of a boundary line approximating the 50 fathom depth (91 meters) contour, south of 34°27′ N. lat., beginning November 1, 2012, through December 31, 2012 (period 6). The Council considered this change as a precautionary measure to address uncertainty in the catch estimates, and to reduce the potential for cowcod mortality to exceed the non-trawl allocation in 2012.

Therefore, the Council recommended and NMFS is implementing a shift to the seaward boundary line of the recreational Rockfish Conservation Area in the Southern Management Area south of 34°27′ N. lat. from the 60 fathom depth contour (110 meters) to the 50 fathom depth contour (91 meters), beginning November 1, 2012, through December 31, 2012 (period 6).

This final rule makes routine inseason adjustments to groundfish fishery management measures based on the best available information and is consistent with the Pacific Coast Groundfish FMP and its implementing regulations.

This action is taken under the authority of 50 CFR 660.60(c) and is exempt from review under Executive Order 12866.

These inseason changes in sablefish limits and recreational RCAs are based on the most recent data available. The aggregate data upon which these actions are based are available for public inspection at the Office of the Administrator, Northwest Region, NMFS, during business hours.

For the following reasons, NMFS finds good cause to waive prior public notice and comment on the revisions to groundfish management measures under 5 U.S.C. 553(b) because notice and comment would be impracticable and contrary to the public interest. Also, for the same reasons, NMFS finds good cause to partially waive the 30-day delay in effectiveness pursuant to 5 U.S.C. 553(d)(3), so that this final rule may become effective November 1, 2012.

At the September Council meeting, the Council recommended that these changes, which are based on the most recent information available, be implemented by November 1, 2012. There was not sufficient time after that meeting to draft this document and undergo proposed and final rulemaking before these actions need to be in effect. For the actions to be implemented in this final rule, affording the time necessary for prior notice and opportunity for public comment would prevent NMFS from managing fisheries using the best available science to approach, without exceeding, the ACLs for federally managed species in accordance with the FMP and applicable law. The adjustments to management measures in this document affect commercial and recreational fisheries in southern California. These adjustments to management measures must be implemented in a timely manner, by November 1, 2012, to: allow OA fixed gear fishermen an opportunity to harvest their limits in 2012 for sablefish without exceeding the ACL south of 36° N. lat.; and to allow recreational fishermen continued opportunities to harvest abundant species, while reducing the potential for cowcod mortality to exceed the non-trawl allocation in 2012. These changes in the OA fixed gear fishery south of 36° and recreational fishery south of 34°27′ N. lat. will continue to allow fishermen opportunities to harvest available healthy stocks while staying within the ACLs for target and overfished species. If this rule is not implemented immediately, the public could have incorrect information regarding allowed OA fixed gear trip limits south of 36°, and recreational rockfish conservation area boundaries south of 34°27′ N. lat. which would cause confusion and be inconsistent with the Council's intent. It would be contrary to the public interest to delay implementation of these changes until after public notice and comment, because making this regulatory change by November 1, 2012, allows harvest as intended by the Council in fisheries that are important to coastal communities in a manner that prevents ACLs of overfished and target species from being exceeded.

No aspect of this action is controversial and no change in operating practices in the fishery is required from those intended in this inseason adjustment.

Delaying these changes would also keep management measures in place that are not based on the best available information. Such delay would impair achievement of the Pacific Coast Groundfish FMP goals and objectives of managing for appropriate harvest levels while providing for year-round fishing and marketing opportunities.

Accordingly, for the reasons stated above, NMFS finds good cause to waive prior notice and comment and to partially waive the delay in effectiveness.

For the reasons set out in the preamble, 50 CFR part 660 is amended as follows: