On August 24, 2011, CBP published a Notice of Proposed Rulemaking (NPRM) in theFederal Register(76 FR 52890), proposing to close the port of entry of Whitetail, Montana, and amend the lists of CBP ports of entry to reflect the change. The primary reason for the proposed closure was the Canada Border Services Agency's (CBSA) closure of its adjacent port of entry of Big Beaver, Saskatchewan, Canada, on April 1, 2011. As set forth in the NPRM, other factors were the limited usage of the port; the locations of the alternative ports of entry of Raymond, Montana, and Scobey, Montana; and the analysis of the net benefit of the port closure, including the cost of necessary renovations were the port to remain open.

CBP received four public comments in response to the NPRM. One commenter supports the closure of Whitetail and three commenters are opposed.

The commenter who supports the proposed closure of the port of Whitetail believes that the costs of operating the port and maintaining the surrounding area are too high considering the low usage. This commenter points out that, using the figures provided in the NPRM for 2007 to 2009, with the annual crossing average of 1,261 cars and 57 trucks and the port's total annual operating cost of $492,000, it currently costs the taxpayers of the United States in excess of $373 for each vehicle to cross at Whitetail. This commenter thinks that these costs are not warranted considering the limited increase in time and mileage that crossers would incur if the port of Whitetail were closed. Additionally, this commenter claims the closure of the port would have no effect on cross border commerce because there are currently no commercial carriers processed at the port. This commenter also asserts that basing any increase in travel time resulting from the proposed closure on the distance from the port of Whitetail to the alternate ports of Raymond and Scobey was not realistic, as the actual increase in mileage would be much less considering the more likely points of origin and destination.

The other three commenters opposed the proposed closure, citing the disruptions the closure would cause them. Two commenters said that the increased travel time would cause them to discontinue their frequent trips from Canada to the United States to buy goods and visit shops and restaurants. Another commenter stated that the closure would increase the cost to the commenter to move hay bales between the commenter's farms in Canada and Montana. This commenter also surmised that the closure could be detrimental to other Canadian and Montanan agricultural producers.

With regard to the comment about increased travel time, CBP acknowledged in the NPRM that using the distance between the ports may overstate the cost of the closure to travelers. However, CBP does not collect data on these travelers' points of origin and destination. Thus, CBP based the analysis on the assumption that the closure would create a detour adding 1 hour and 40 miles to each crosser's trip. The actual additional time and mileage U.S. travelers may incur to drive to an alternate port may be less.

With regard to the comments about usage and cost, as discussed in the NPRM, the port of Whitetail is one of CBP's least trafficked ports and has processed an average of less than 4 vehicles per day for the last 4 years. From 2007 to 2009, Whitetail averaged only 1,318 cars and trucks a year. More recently, in fiscal year 2011, southbound traffic dropped to less than 960 vehicles, with almost all of the decrease in southbound traffic occurring after CBSA closed the port of Big Beaver to northbound traffic in April 2011. The commercial traffic is even lower. In fiscal year 2011 CBP processed only 24 commercial vehicles at the port of Whitetail. This was a significant decrease from the already low annual average of about 60 commercial vehicles between 2007 and 2009. Notwithstanding this very low usage, as explained in the NPRM, CBP would incur substantial costs in order to keep the port open. In addition to the nearly $500,000 annual operational budget, CBP would need to construct a replacement facility, an estimated $8 million cost, because the current facility does not have the infrastructure to meet modern operational, safety, and technological demands for ports of entry. Although CBP regrets the disruptions to personal and business routines that some individuals will experience due to the closure of Whitetail, CBP cannot justify the above-referenced costs for so few vehicles.

After consideration of the comments received, the low usage of the port, the locations of the alternative ports of entry, and the analysis of the net benefit of the port closure, including the cost ofnecessary renovations were the port to remain open, CBP is closing the port of entry of Whitetail, Montana. The lists of CBP ports of entry at 8 CFR 100.4(a) and 19 CFR 101.3(b)(1) are being amended to reflect the change.

CBP is working with the Montana Department of Transportation and CBSA to identify the permanent barrier and signage necessary to prevent entry and reroute traffic to nearby ports of entry. CBP expects that any impact on the environment and any costs incurred for this purpose will be minimal. If necessary, CBP will conduct appropriate environmental studies in the course of decommissioning and prior to facility demolition.

On September 28, 2010, the Commissioner of CBP notified Congress of CBP's intention to close the port of entry at Whitetail, Montana, fulfilling the congressional notification requirements of 19 U.S.C. 2075(g)(2) and section 417 of the Homeland Security Act (6 U.S.C. 217).

The signing authority for this document falls under 19 CFR 0.2(a). Accordingly, this final rule is signed by the Secretary of Homeland Security.

This rule is not a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563, and has not been reviewed by the Office of Management and Budget under that order. Nevertheless, CBP provided its assessment of the benefits and costs of this regulatory action in the NPRM and CBP adopts the NPRM's economic analysis for this final rule without any change.

In summary, if the port of entry of Whitetail, Montana remained open, it would need significant renovation to meet current safety and security standards, which CBP estimates would cost approximately $8 million. Whitetail also costs CBP approximately $500,000 in yearly operating expenses to pay for staff and utilities. If Whitetail closed, travelers would need to find an alternative crossing. As alternative crossings would require travelers to travel additional miles, CBP estimates travelers would incur an additional $104,000 annually in additional driving time and mileage costs if the Whitetail crossing was not available. In addition, if Whitetail was closed, CBP would incur a onetime cost of $158,000 in closure expenses. Thus, the net benefit of the Whitetail closure is about $8.2 million the first year and $396,000 each year after that.

The Regulatory Flexibility Act (5 U.S.C. 601et seq.) requires federal agencies to examine the impact a rule would have on small entities. A small entity may be a small business (defined as any independently owned and operated business not dominant in its field that qualifies as a small business per the Small Business Act); a small not-for-profit organization; or a small governmental jurisdiction (locality with fewer than 50,000 people).

Because CBP does not collect data on the number of small businesses that use the port of Whitetail, we cannot estimate how many would be affected by this rule. However, an average of less than four vehicles crossed into the United States at Whitetail each day even before closure of the Canadian port of Big Beaver further reduced traffic. Commercial traffic is even lower—an average of fewer than 60 commercial vehicles crossed at Whitetail each year from 2007 to 2009, with only 24 commercial vehicles crossing in fiscal year 2011. The assessment of the benefits and costs of this regulatory action included in the NPRM concluded that the total cost of the rule to the public is about $104,000 a year, even assuming the longest possible detour for all traffic. DHS does not believe that this cost rises to the level of a significant economic impact. DHS thus believes that this rule will not have a significant economic impact on a substantial number of small entities. DHS did not receive any comments contradicting this finding. Accordingly, DHS certifies that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

The rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

For the reasons set forth above, DHS amends part 100 of title 8 of the Code of Federal Regulations and part 101 of title 19 of the Code of Federal Regulations as set forth below.

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 theFederal Registeron September 12, 2012 (77 FR 56172). That NPRM proposed to correct an unsafe condition for the specified products. The Mandatory Continuing Airworthiness Information (MCAI) states:

The unsafe condition is a possible fracture of the MLG bogie beam, which, under high speed, could ultimately result in the airplane departing the runway, the bogie beam detaching from the airplane, or collapse of the MLG; and consequent structural damage to the airplane and injury to the occupants. You may obtain further information by examining the MCAI in the AD docket.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (77 FR 56172, September 12, 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 56172, September 12, 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 56172, September 12, 2012).

We estimate that this AD will affect 53 products of U.S. registry. We also estimate that it will take about 16 work-hours per MLG bogie beam (2 MLG bogie beams per airplane) to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $255,000 per MLG bogie beam. 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 up to $27,174,160, or $256,360 per MLG bogie beam.

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 athttp://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 56172, September 12, 2012), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in theADDRESSESsection. 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:

On July 23, 2012, we issued AD 2012-15-15, Amendment 39-17144 (77 FR 52212, August 29, 2012), which superseded AD 2004-09-32, Amendment 39-13622 (69 FR 25481, May 7, 2004), for certain The Boeing Company Model 757-200, -200CB, and -300 series airplanes. AD 2012-15-15 requires initial and repetitive inspections of the fuselage skin and bear strap at the forward, upper corner of the L1 entry door cutout for cracking, and repair if necessary. That action also provides an optional terminating action for the repetitive inspections. That AD also requires additional inspections for airplanes having repairs or preventative modifications installed and inspections for certain other airplanes. That AD resulted from reports of additional cracking in the fuselage skin. We issued that AD to detect and correct cracking of the fuselage skin and bear strap at the forward upper corner of the L1 entry door cutout, which could result in reduced structural integrity of the L1 entry door, and consequent rapid decompression of the airplane.

Since we issued AD 2012-15-15, Amendment 39-17144 (77 FR 52212, August 29, 2012), it was noted that certain airplane group configurations included in paragraph (n) of the NPRM were inadvertently removed in the final rule. This AD includes Group 1, Configuration 4, and Group 2, Configuration 3, in paragraph (n) of this AD.

We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This AD requires retaining all requirements of AD 2012-15-15, Amendment 39-17144 (77 FR 52212, August 29, 2012).

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of thisrule because all actions of AD 2012-15-15, Amendment 39-17144 (77 FR 52212, August 29, 2012), are retained and include certain airplane group configurations in paragraph (n) of this AD that were specified in the NPRM (76 FR 81890, December 29, 2011), but were inadvertently removed in the final rule of AD 2012-15-15. Therefore, we find that notice and opportunity for prior public comment are unnecessary and that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments before it becomes effective. However, we invite you to send any written data, views, or arguments about this AD. Send your comments to an address listed under theADDRESSESsection. Include the docket number FAA-2012-1228 and directorate identifier 2012-NM-190-AD at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

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

We estimate that this AD affects 591 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

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 part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2012-0201, dated September 26, 2012 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

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

On November 20, 2007, we issued AD 2007-24-09 (72 FR 67568, November 29, 2007) which corresponds with EASA AD 2007-0260R1. Our AD has a mandatory terminating action date of May 31, 2010, however, there were, and currently are, no U.S. operators of the engines affected by those ADs. Those ADs are only applicable to engines that do not incorporate Modification Standard 72-F117. Since those ADs were issued, EASA has issued AD 2012-0201 that is applicable to a specific set of engines that may have had Modification Standard 72-F117 incorporated incorrectly. EASA did not supersede EASA AD 2007-0260R1 with EASA AD 2012-0201 because EASA AD 2012-0201 only affects a very specific population of engines that, having incorporated Modification Standard 72-F117, either correctly or incorrectly, are no longer affected by EASA AD 2007-0260R1. We are issuing our AD as a standalone document for the same reasons. This new AD also is applicable only to the engines specified in the MCAI, none of which are currently registered to U.S. operators. Also, this new AD lists certain service bulletins that were previously incorporated by reference in AD 2007-24-09.

RR has issued Alert Service Bulletin No. RB.211-72-AG873, dated February 27, 2012. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

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

No domestic operators use any of the RB211-Trent 768-60, 772-60, and 772B-60 turbofan engines listed by S/N in this AD. Therefore, we find that notice and opportunity for prior public comment are unnecessary and that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under theADDRESSESsection. Include “Docket No. FAA-2012-1198; Directorate Identifier 2012-NE-35-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

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

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); and

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

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

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 to include an AD that would apply to the specified products. That NPRM was published in theFederal Registeron August 27, 2012 (77 FR 51717), and proposed to supersede AD 2010-06-05, Amendment 39-16229 (75 FR 11435, March 11, 2010). 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 51717, August 27, 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.

We estimate that this AD will affect about 134 products of U.S. registry.

The actions that are required by AD 2010-06-05, Amendment 39-16229 (75 FR 11435, March 11, 2010), and retained in this AD take about 3 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 $255 per product.

We estimate that it will take about 3 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 $34,170, or $255 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 athttp://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 51717, August 27, 2012), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in theADDRESSESsection. 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:

On September 11, 2012, the FAA published in theFederal Registera notice of proposed rulemaking (NPRM) to establish controlled airspace at Spanish Peaks Airfield, Walsenburg, CO (77 FR 55776). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005, of FAA Order 7400.9W dated August 8, 2012, and effective September 15, 2012, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in that Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by establishing Class E airspace extending upward from 700 and 1,200 feet above the surface, at Spanish Peaks Airfield, Walsenburg, CO, to accommodate IFR aircraft executing new RNAV (GPS) standard instrument approach procedures at the airport. Also, the geographic coordinates of the airport are updated to coincide with the FAA's aeronautical database. This action is necessary for the safety and management of IFR operations.

The FAA has determined this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 discusses the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at Spanish Peaks Airfield, Walsenburg, CO.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The current time of designation of restricted area R-6501B reads“Intermittent.” The term “intermittent” signifies limited or infrequent use the area. FAA Order 7400.2 requires that an “intermittent” time of designation for special use airspace areas must include either an associated time period or a “by NOTAM” provision. In all cases, an `intermittent” time of designation must not be used for restricted areas without a “by NOTAM” provision.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 73 by changing the time of designation for Restricted area R-6501B, Underhill, VT, from “Intermittent” to “Intermittent by NOTAM 24 hours in advance.” This change brings the time of designation into compliance with FAA Order 7400.2 requirements.

This change adds a NOTAM requirement to the time of designation of R-6501B. The change benefits the flying public by providing advance notice of planned activation periods of the restricted area. Because the amendment does not affect the boundaries, designated altitudes, or activities conducted within the restricted area and provides the public with advance notice of restricted area usage, notice and public procedures under 5 U.S.C. 553(b) are unnecessary.

The FAA has determined that this action only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with 311d., FAA Order 1050.1E, Environmental Impacts: Policies and Procedures. This airspace action is an administrative change to the description of the affected restricted area to clarify the time of designation. It does not alter the dimensions, altitudes, or activities conducted within the airspace; therefore, it is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exists that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 73 as follows:

On December 30, 2009, the IRS and the Treasury Department published final and temporary regulations and a notice of proposed rulemaking by cross-reference to temporary regulations in theFederal Register(74 FR 69021, TD 9477, 2010-1 CB 385; REG-132232-08, 74 FR 69043) (2009 regulations) under section 304. A correction to the 2009 regulations was published in theFederal Registeron February 26, 2010 (75 FR 8796). The 2009 regulations amended the anti-abuse rule of § 1.304-4T, which was published in theFederal Registeron June 14, 1988 (TD 8209), to address transactions that are subject to section 304 but are structured with a principal purpose of avoiding the application of section 304 to certain corporations. No public hearing on the 2009 regulations was requested or held, and no written comments were received. Accordingly, this Treasury decision adopts the 2009 regulations without change as final regulations and removes the temporary regulations under section 304.

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) and (d) of the Administrative Procedure Act (5 U.S.C. Chapter 6) do not apply to these regulations. For applicability of the Regulatory Flexibility Act (5 U.S.C. Chapter 6), it is hereby certified that this rule will not have a significant economic impact on a substantial number of small entities. These regulations primarily will affect large corporations. Thus, the number of affected small entities will not be substantial. Pursuant to section 7805(f) of the Internal Revenue Code, the notice of proposed rulemaking preceding this regulation was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comments on its impact on small business.

The principal author of the regulations is Ryan A. Bowen of the Office of Associate Chief Counsel (International). However, other personnel from the IRS and the Treasury Department participated in their development.

Accordingly, 26 CFR part 1 is amended as follows:

This document and additional information concerning OFAC are available from OFAC's Web site (www.treas.gov/ofac). Certain general information pertaining to OFAC's sanctions programs also is available via facsimile through a 24-hour fax-on-demand service, tel.: 202/622-0077.

On October 22, 2012, the Department of the Treasury's Office of Foreign Assets Control (“OFAC”) published afinal rule in theFederal Register(77 FR 64664) changing the heading of the former Iranian Transactions Regulations to the Iranian Transactions and Sanctions Regulations, 31 CFR part 560 (the “ITSR”), amending the renamed ITSR, and reissuing them in their entirety, to implement Executive Order 13599 of February 5, 2012 (“E.O. 13599”), and sections 1245(c) and (d)(1)(B) of the National Defense Authorization Act for Fiscal Year 2012 (Pub. L. 112-81). This final rule made many significant amendments, as well as technical and conforming changes, to the ITSR. OFAC is now amending the ITSR to implement the sections discussed below of Executive Order 13622 of July 30, 2012, “Authorizing Additional Sanctions With Respect to Iran” (“E.O. 13622”), the Iran Threat Reduction and Syria Human Rights Act of 2012 (Pub. L. 112-158) (the “TRA”), and Executive Order 13628 of October 9, 2012, “Authorizing the Implementation of Certain Sanctions Set Forth in the Iran Threat Reduction and Syria Human Rights Act of 2012 and Additional Sanctions With Respect to Iran” (“E.O. 13628”).

On July 30, 2012, the President, invoking the authority of,inter alia,the International Emergency Economic Powers Act (50 U.S.C. 1701et seq.) (“IEEPA”), issued E.O. 13622. The President issued E.O. 13622 to take additional steps with respect to the national emergency declared in Executive Order 12957 of March 15, 1995 (“E.O. 12957”), particularly in light of the Government of Iran's use of revenues from petroleum, petroleum products, and petrochemicals for illicit purposes, Iran's continued attempts to evade international sanctions through deceptive practices, and the unacceptable risk posed to the international financial system by Iran's activities.

Section 5 of E.O. 13622 blocks all property and interests in property that are in the United States, that hereafter come within the United States, or that are or hereafter come within the possession or control of any U.S. person, including any foreign branch, of any person determined by the Secretary of the Treasury, in consultation with the Secretary of State, to have materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services in support of, the National Iranian Oil Company (“NIOC”), the Naftiran Intertrade Company (“NICO”), or the Central Bank of Iran, or the purchase or acquisition of U.S. bank notes or precious metals by the Government of Iran. Section 10 of E.O. 13622 defines the termsNIOCandNICOas including any entity owned or controlled by, or operating for or on behalf of, respectively, NIOC and NICO.

Section 6 of E.O. 13622 provides that section 5(a) of the order, among other specified provisions, shall not apply to any person for conducting or facilitating a transaction involving a natural gas development and pipeline project initiated prior to July 31, 2012, to bring gas from Azerbaijan to Europe and Turkey, as described in section 6. Although it is not named in the section, section 6 refers to the Shah Deniz natural gas field in Azerbaijan's sector of the Caspian Sea and related pipeline projects to bring the gas from Azerbaijan to Europe and Turkey.

On August 10, 2012, the President signed into law the TRA. Section 218 of the TRA directs the President to prohibit entities owned or controlled by a United States person and established or maintained outside the United States from knowingly engaging in any transaction directly or indirectly with the Government of Iran or any person subject to the jurisdiction of the Government of Iran that would be prohibited by an order or regulation issued pursuant to IEEPA if the transaction were engaged in by a United States person or in the United States. Section 218 also extends civil penalty liability under IEEPA to U.S. parent companies if the foreign entities they own or control violate, attempt to violate, conspire to violate, or cause a violation of any order or regulation issued to implement this section. The law allows the U.S. person to avoid civil penalties for violations if it divests or terminates its business with the foreign entity by February 6, 2013.

Sections 602 and 603 of the TRA provide that nothing in that law, including section 218, shall apply to, respectively, the authorized intelligence activities of the United States and any activity relating to a project for the development of natural gas and the construction and operation of a pipeline to transport natural gas from Azerbaijan to Turkey and Europe that meets certain specified criteria. The project that meets the criteria in section 603 is the project to develop the Shah Deniz natural gas field in Azerbaijan's sector of the Caspian Sea and related pipeline projects to bring the gas from Azerbaijan to Europe and Turkey, as discussed above in connection with section 6 of E.O. 13622. The exemption in section 603 will not apply in the event that the President makes certain certifications to Congress to the effect that an Iranian entity's share of the project has increased relative to its share on January 1, 2002, or that an Iranian entity has assumed an operational role in the project, as described in section 603(b) of the TRA.

On October 9, 2012, the President, invoking the authority of,inter alia,IEEPA and the TRA, issued E.O. 13628, in order to take additional steps to deal with the national emergency declared in E.O. 12957 with respect to Iran. In implementation of section 218 of the TRA, section 4(a) of E.O. 13628 prohibits entities owned or controlled by a United States person and established or maintained outside the United States from knowingly engaging in any transactions, directly or indirectly, with the Government of Iran or any person subject to the jurisdiction of the Government of Iran, if the transactions would be prohibited by E.O. 12957, Executive Order 12959 of May 6, 1995, Executive Order 13059 of August 19, 1997, E.O. 13599, section 5 of E.O. 13622, or section 12 of E.O. 13628, or any regulation issued pursuant to the foregoing, if the transaction were engaged in by a United States person or in the United States. Section 4(d) of E.O. 13628 provides that the prohibition in section 4(a) applies except to the extent provided by statutes, or in regulations, orders directives, or licenses that may be issued pursuant to this order.

Section 4(b) of E.O. 13628 provides that penalties for violations of the prohibition in section 4(a) may be assessed against the United States person that owns or controls the foreign entity that engaged in the prohibited transaction. Section 4(c) provides that such penalties shall not apply if the United States person that owns or controls the foreign entity divests or terminates its business with that entity not later than February 6, 2013.

Today, OFAC is amending the ITSR to implement sections 5 and 6 of E.O. 13622, sections 218, 602, and 603 of the TRA, and section 4 of E.O. 13628. To implement the relevant provisions of E.O. 13622, OFAC is amending paragraph (c) of section 560.211 of the ITSR to add the new blocking criteria set forth in section 5(a) of the order, as well as the exemption from this new authority for a natural gas development and pipeline project described in section 6 of the order.

OFAC is making a number of changes to the ITSR to implement the relevant provisions of the TRA and E.O. 13628. First, new section 560.215 is being added to subpart B of the ITSR to prohibit entities owned or controlled by a United States person and established or maintained outside the United States from knowingly engaging in anytransaction directly or indirectly with the Government of Iran or any person subject to the jurisdiction of the Government of Iran that would be prohibited by the ITSR if the transaction were engaged in by a United States person or in the United States. This new section also contains the exemptions set forth in sections 602 and 603 of the TRA for, respectively, U.S. intelligence activities and a natural gas-related project, as described above.

Second, new section 560.555 is being added to subpart E of the ITSR to authorize, from October 9, 2012, through March 8, 2013, all transactions ordinarily incident and necessary to the winding-down of transactions prohibited by new section 560.215, provided that the authorized transactions do not involve a U.S. person or occur in the United States. Paragraph (b) of section 560.555 specifies that this new general license does not authorize any transactions prohibited by section 560.205. Paragraph (c) of section 560.555 provides that transactions involving Iranian financial institutions are authorized pursuant to this new general license only if the property and interests in property of the Iranian financial institution are blocked solely pursuant to this part.

Third, another general license, new section 560.556, is being added to subpart E of the ITSR to authorize an entity owned or controlled by a United States person and established or maintained outside the United States (a “U.S.-owned or -controlled foreign entity”) to engage in a transaction otherwise prohibited by section 560.215 that would be authorized by a general license set forth in or issued pursuant to this part if engaged in by a U.S. person or in the United States. Paragraph (b) of new section 560.556 provides that this section does not authorize any transaction by a U.S.-owned or -controlled foreign entity otherwise prohibited by section 560.215 if the transaction would be prohibited by any other part of chapter V of 31 CFR if engaged in by a U.S. person or in the United States.

Fourth, OFAC is amending several existing general licenses that, by their terms, apply to transactions by U.S.-owned or -controlled foreign entities to exclude from the scope of each authorization any transaction by a U.S.-owned or -controlled foreign entity otherwise prohibited by section 560.215 if the transaction would be prohibited by any other part of chapter V of 31 CFR if engaged in by a U.S. person or in the United States. This change is being made to sections 560.508, 560.509, 560.510, 560.522, 560.525, 560.530, 560.532, 560.539, and 560.553. OFAC is making further conforming changes to sections 560.532 and 560.539 to account for the new prohibition in section 560.215.

Fifth, OFAC is amending section 560.701 of subpart G of the ITSR by adding new paragraph (a)(3), which provides for civil penalties under section 206(b) of IEEPA (50 U.S.C. 1705(b)) to be imposed on a United States person if an entity owned or controlled by the United States person and established or maintained outside the United States violates, attempts to violate, conspires to violate, or causes a violation of the prohibition set forth in section 560.215, unless the United States person divests or terminates its business with the entity by February 6, 2013, such that the U.S. person no longer owns or controls the entity, as defined in new section 560.215.

Finally, OFAC is making two technical corrections to section 560.505 of subpart E of the ITSR.

Because the amendment of the ITSR involves a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.

The collections of information related to the ITSR are contained in 31 CFR part 501 (the “Reporting, Procedures and Penalties Regulations”). Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information have been approved by the Office of Management and Budget under control number 1505-0164. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.

For the reasons set forth in the preamble, the Department of the Treasury's Office of Foreign Assets Control amends part 560 of 31 CFR chapter V as follows:

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. The Coast Guard has tracked low water conditions throughout the Western Rivers during the summer and fall of 2012. Throughout this time, it has not been possible to accurately predict the extent to which rivers may be affected due to uncertainties with local weather, specifically rainfall amounts. On November 20, 2012 the United States Army Corps of Engineers (USACE) and Coast Guard hosted a joint meeting with the River Industry Action Committee (RIAC), the industry committee for the Upper Mississippi River (UMR), in St. Louis, MO. During this meeting the USACE noted that approximately two-thirds of the continental United States continues to be affected by an ongoing and persistent drought. As a result of the drought and the normal annual reduced flows per the operational plan for the Missouri River, they predicted extreme low water conditions in the UMR beginning in early December 2012. Therefore, various control measures or directions to vessels operating on the UMR are immediately needed to address safe navigation concerns brought on by the extreme low water conditions. Due to the timing of the actual notice of definitive low water conditions, there is not enough time to complete the NPRM process before the onset of extreme low water conditions that will expose persons and property to safety hazards, contrary to the public interest.

For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in theFederal Register. Providing 30 days notice and delaying the RNA's effective date would be contrary to public interest because immediate action is needed to protect persons, property and infrastructure from the potential damage and safety hazards associated with low water conditions on the UMR.

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 RNAs.

The purpose of this RNA is to address safe navigation concerns for persons and vessels while extreme low water conditions exist on the UMR from mile 0.0 to mile 185.0. The extreme low water conditions pose significant safety hazards to vessels and mariners operating on the UMR. For this reason, the Coast Guard is establishing this RNA to implement various waterway operational controls that vessels will have to follow while operating on the UMR.

The Coast Guard is establishing a temporary RNA for all vessel traffic on the UMR between mile 0.0 and 185.0, extending the entire width of the river. Within this RNA various restrictions and requirements may be put into effect based on actual or projected channel widths and depths. These restrictions and requirements will be the minimum necessary for the protection of persons, property and infrastructure from the potential damage and safety hazards associated the extreme low water and may include, but are not limited to, limitations on tow size, tow configuration, vessel/barge draft, assist vessels, speed, under keel clearance, vessel traffic reporting, hours of transit, one way traffic, and use of Automatic Identification System (AIS) if fitted onboard a vessel. Enforcement times and specific restrictions and requirements for the entire regulated navigation area, or specific areas within the regulated navigation area, will be announced via Broadcast Notice to Mariners (BNM), through outreach with RIAC,the Local Notice to Mariners, and through other public notice.

Any deviation from the requirements put into place are prohibited unless specifically authorized by the COTP Ohio Valley, COTP Upper Mississippi River, or a designated representative. Deviations for the specific restrictions and regulations will be considered and reviewed on a case-by-case basis. The COTP Ohio Valley may be contacted by telephone at 1-800-253-7465. The COTP Upper Mississippi River may be contacted by telephone at 314-269-2332. All COTPs can be reached by VHF-FM channel 16.

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 rule establishes a temporary RNA for vessels on all waters of the UMR from mile 0.0 to mile 185.0. Notifications of enforcement times of control measures and requirements put into effect for the entire RNA, or specific areas within the RNA, will be communicated to the marine community via BNM, through outreach with RIAC, Local Notice to mariners, and through other public notice. The impacts on navigation will be limited to addressing the safety of mariners and vessels associated with hazards due to river conditions during low water. Operational controls under this RNA will be the minimum necessary to protect mariners, vessels, the public, and the environment from risks due to extreme low water conditions.

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 may be small entities: the owners or operators of vessels intending to transit the UMR, from December 1, 2012 to March 31, 2013. This RNA will not have a significant economic impact on a substantial number of small entities because traffic in this area is limited almost entirely to recreational vessels and commercial towing vessels, and this rule allows vessels to pass through the area, subject to certain restrictions. Notifications to the marine community will be made through BNM, communications with RIAC, and other public notice. Notices of changes to the RNA 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 inunderstanding 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 theFOR 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 theADDRESSESsection.

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

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 November 27, 2012. As a result, the Coast Guard did not have sufficient time to publish an 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 theFederal Register.

The legal basis for the rule is the Coast Guard's authority to establish regulated navigation areas and other limited access areas: 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, 160.5; Public Law 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.

The purpose of the rule is to protect race participants, participant vessels, spectators, and the general public from the hazards associated with the event.

On January 12, 2013, Questor Multisport, LLC is hosting the Bone Island Triathlon. The event will be held on the waters of the Atlantic Ocean located south of Key West, Florida. Approximately 1000 swimmers will be participating in the race. It is anticipated that at least 10 spectator vessels will be present during the races.

The safety zone encompasses certain waters of the Atlantic Ocean located south of Key West, Florida. The safety zone will be enforced from 7 a.m. until 12 p.m. on January 12, 2013. All persons and vessels, except those participating in the event, are prohibited from entering, transiting, anchoring, or remaining in the safety zone area.

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 Key West by telephone at 305-292-8727, 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 Key West or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Key West or a designated representative. The Coast Guard will provide notice of the regulated area 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 14 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) ofExecutive 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 safety zone will only be enforced for five hours; (2) vessel traffic in the area is expected to be minimal during the enforcement period; (3) although persons and vessels will not be able to enter, transit through, anchor in, or remain within the safety zone without authorization from the Captain of the Port Key West or a designated representative, they may operate in the surrounding area during the enforcement period; (4) persons and vessels may still enter, transit through, anchor in, or remain within the safety zone if authorized by the Captain of the Port Key West or a designated representative; and (5) the Coast Guard will provide advance notification of the safety zone 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 safety zone from 7:00 a.m. until 12:00 p.m. on January 12, 2013. 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 theFOR 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 theFOR FURTHER INFORMATION CONTACTsection 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 concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the humanenvironment. This rule is categorically excluded, under Figure 2-1, paragraph (34)(g), of the Instruction. This rule involves establishing a temporary safety zone that will be enforced for a total of five hours. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated underADDRESSES.

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

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 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 mustidentify docket ID number EPA-HQ-OPP-2012-0900 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 February 25, 2013. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0900, 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 CBI or other information whose disclosure is restricted by statute.

•Mail:OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (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 athttp://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available athttp://www.epa.gov/dockets.

EPA, on its own initiative, in accordance with FFDCA sections 408(e) and 408(l)(6), 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a time-limited tolerance for residues of spirotetramat, including its metabolites and degradates, in or on watercress at 1.5 parts per million (ppm). This time-limited tolerance expires on December 31, 2015.

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

Section 408(b)(2)(A)(i) of 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. * * *”

Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

This is the first Section 18 request received for the use of spirotetramat on watercress. Florida and Tennessee are experiencing high pest pressure from melon/cotton aphids in the watercress industry. Aphids infest watercress fields from surrounding areas, and attack the apical stem tips of plants. Watercress plants respond with reduced vigor (growth rate) and yields per acre (bunch number) are subsequently reduced. Due to lack of effective alternative insecticides, increasing resistance to the historically effective insecticide imidacloprid, and marketable yield losses, the Agency has determined the situation is non-routine and urgent and likely to result in significant economic losses. After having reviewed the submission, EPA determined that an emergency condition exists for these States, and that the criteria for approval of an emergency exemption are met. EPA has authorized a specific exemption under FIFRA section 18 for the use of spirotetramat on watercress for control of melon/cotton aphids in Florida and Tennessee.

As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of spirotetramat in or on watercress. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation, and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in FFDCA section 408(l)(6). Although these time-limited tolerances expire on December 31, 2015, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on watercress after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether spirotetramat meets FIFRA's registration requirements for use on watercress or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of spirotetramat by a State for special local needs under FIFRA section 24(c). Nor does this tolerance by itself serve as the authority for persons in any State, other than Florida and Tennessee, to use this pesticide on the applicable crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for spirotetramat, contact the Agency's Registration Division at the address provided underFOR FURTHER INFORMATION CONTACT.

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 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 expected as a result of the emergency exemption requests and the time-limited tolerance for residues of spirotetramat, including its metabolites and degradates, in or on watercress at 1.5 ppm. EPA's assessment of exposures and risks associated with establishing a time-limited tolerance follows.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern (LOC) 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, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.A summary of the toxicological endpoints for spirotetramat used for human risk assessment is discussed in Unit III.B. of the final rule published in theFederal Registerof May 18, 2011 (76 FR 28675) (FRL-8865-8).

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to spirotetramat, EPA considered exposure under the time-limited tolerance established by this action as well as all existing spirotetramat tolerances in § 180.641. EPA assessed dietary exposures from spirotetramat in food as follows:

i.Acute and chronic exposure.Such effects were identified for spirotetramat. In estimating acute and chronic dietary exposure, EPA used food consumption information from the U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA used tolerance-level residues and 100 percent crop treated (PCT) for all commodities. Empirical processing factors were used for apple, orange, grape and tomato juice, applesauce, and dried apples, and Dietary Exposure Evaluation Model (DEEM (Ver. 7.81)) default processing factors were used for the remaining processed commodities (where provided).

ii.Cancer.Based on the data summarized in Unit IV.A., EPA has concluded that spirotetramat does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iii.Anticipated residue and PCT information.EPA did not use anticipated residue and/or PCT information in the dietary assessment for spirotetramat. Tolerance level residues and 100 PCT were assumed for all food commodities.

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

Based on the Tier 1 Rice Model and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of total toxic residues (TTR) of spirotetramat, spirotetramat-enol, and spirotetramat-ketohydroxy for acute and chronic exposures are estimated to be 158 parts per billion (ppb) for surface water and 3.96 × 10−4ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute and chronic dietary risk assessment, the water concentration value of 158 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). There are currently no registered or proposed residential uses for spirotetramat; therefore a residential exposure assessment was not conducted.

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 spirotetramat to share a common mechanism of toxicity with any other substances, and spirotetramat does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that spirotetramat 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 athttp://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 ofsafety 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 Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional SF when reliable data available to EPA support the choice of a different factor.

2.Prenatal and postnatal sensitivity.Based on the results of developmental toxicity studies in rats and rabbits and two reproduction studies in rats with spirotetramat, there was no evidence of increased susceptibility of offspring following prenatal or postnatal exposure.

3.Conclusion.EPA has determined that reliable data show that the safety of infants and children would be adequately protected if the Food Quality Protection Act (Pub. L. 104-170) Safety Factor (FQPA SF) were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for spirotetramat is complete, except for a subchronic neurotoxicity study which is now required as part of the revisions to 40 CFR part 158. However, the existing toxicological database indicates that spirotetramat is not a neurotoxic chemical in mammals. In addition, acute, subchronic and developmental neurotoxicity studies available for structurally-related compounds (spirodiclofen and spiromesifen) do not show evidence of neurotoxicity in adults or young.

ii. There is no indication that spirotetramat 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 spirotetramat results in increased susceptibility inin uterorats or rabbits in the prenatal developmental studies or in young rats, in both the 1- and 2-generation reproduction studies.

iv. There are no residual uncertainties identified in the exposure databases that will result in underestimation of exposure. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to spirotetramat in drinking water. These assessments will not underestimate the exposure and risks posed by spirotetramat.

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 spirotetramat will occupy 10% of the aPAD for children ages 1-2 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 spirotetramat from food and water will utilize 83% of the cPAD for children ages 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for spirotetramat.

3.Short-term and Intermediate-term risk.Short- and intermediate-term aggregate exposure takes into account short-term and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). A short-term and intermediate-term adverse effect was identified; however, spirotetramat is not registered for any use patterns that would result in short-term or intermediate-term residential exposure. Short-term and intermediate-term risk is assessed based on short-term or intermediate-term residential exposure plus chronic dietary exposure. Because there is no short-term or intermediate-term residential exposure 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-term risk), no further assessment of short-term or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term and intermediate-term risk for spirotetramat.

4.Aggregate cancer risk for U.S. population.Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, spirotetramat is not expected to pose a cancer risk to humans.

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 spirotetramat residues.

Adequate enforcement methodology, high-performance liquid chromatography with tandem spectrometry (HPLC-MS/MS), is available to enforce the tolerance expression.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:residuemethods@epa.gov.

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 Codex has not established a MRL for spirotetramat.

Therefore, time-limited tolerances are established for residues of spirotetramat, including its metabolites and degradates, in or on watercress at 1.5 ppm. This tolerance expires on December 31, 2015.

This final rule establishes tolerances under FFDCA sections 408(e) and 408(l)(6). 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. 3501et 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 in accordance with FFDCA sections 408(e) and 408(l)(6), such as the tolerances 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. 601et 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) (2 U.S.C. 1501et seq.).

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) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in theFederal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180through the Government Printing Office's e-CFR site athttp://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.To access the OCSPP test guidelines referenced in this document electronically, please go tohttp://www.epa.gov/ocsppand select “Test Methods and Guidelines.”

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-2012-0750 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 February 25, 2013. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0750, 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 CBI or other information whose disclosure is restricted by statute.

•Mail:OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (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 athttp://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available athttp://www.epa.gov/dockets.

In theFederal Registerof September 28, 2012 (77 FR 59576) (FRL-9363-8), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 2F8075 by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, Wilmington, DE 19808. The petition requested that 40 CFR 180.585 be amended by extending the expiration date for temporary tolerances for residues of the herbicide, pyraflufen-ethyl, pyraflufen-ethyl, ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate and its acid metabolite, E-1, 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetic acid, in or on: Cattle, meat byproducts; goat, meat byproducts; horse, meat byproducts; sheep, meat byproducts; and milk until December 31, 2016. That document referenced a summary of the petition prepared by Nichino America, Inc., the registrant, which is available to the public in the docket,http://www.regulations.gov.Comments were received on the notice of filing. EPA's response to those comments is discussed in Unit IV.C. These tolerances expire on December 31, 2016.

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 pyraflufen-ethyl including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pyraflufen-ethyl follows.

In 2008, the EPA assessed the use of pyraflufen-ethyl on pasture and rangeland grasses. The existing cattle feeding study conducted at the 5X dose was sufficient to establish tolerances for cattle, goat, horse, and sheep meat byproducts and milk; however, since the OPPTS 860.1480 guidelines require that the cattle feeding study be conducted at a 10X dose, the Agency set time-limited tolerances (Federal Registerof September 5, 2008 (73 FR 51739) until a new feeding study at the 10X dose could be submitted for permanent tolerances to be established.

In the most recent pyraflufen-ethyl tolerance rulemaking, 76 FR 31479 (June 1, 2011) EPA assessed risk of aggregate exposure to pyraflufen-ethyl assuming that exposure occurred in animal meat byproducts and milk at the levels of the established time-limited tolerances. In that action, EPA determined that aggregate risk from exposure was safe. The dietary exposure estimates assumed 100 percent crop treated, so EPA is confident that aggregate dietary exposure is not underestimated and concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children, from aggregate exposure to pyraflufen-ethyl residues. This action to extend time-limited tolerances for animal meat byproducts and milk relies on the assessments supporting the June 1, 2011 rulemaking. These assessments are posted to docket ID, EPA-HQ-OPP-2010-0426 athttp://www.regulations.gov.

Adequate enforcement methodology (Gas Chromatography with Mass Spectrometry (GC/MS)) is available to enforce the tolerance expression.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards wheneverpossible, 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 Codex has not established a MRL for pyraflufen-ethyl.

EPA received one comment to the Notice of Filing that made a general objection to establishing and/or extending tolerances for pesticides. The Agency recognizes that some individuals believe that certain pesticide chemicals should not be permitted in our food. 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. When new or amended tolerances are requested for residues of a pesticide in food or feed, the Agency, as is required by section 408 of the FFDCA, estimates the risk of the potential exposure to these residues. The Agency has concluded after this assessment, that there is a reasonable certainty that no harm will result from aggregate human exposure to pyraflufen-ethyl and that, accordingly, the pyraflufen-ethyl temporary tolerances for cattle, goat, horse and sheep meat byproducts, and milk are “safe” and can be extended.

Therefore, time-limited tolerances are extended to December 31, 2016 for residues of pyraflufen-ethyl, pyraflufen-ethyl, ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate and its acid metabolite, E-1, 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetic acid, in or on: Cattle, meat byproducts; goat, meat byproducts; horse, meat byproducts; sheep, meat byproducts; and milk. A time limitation has been imposed until a cattle feeding study at the 10X dose is found acceptable to support permanent tolerances.

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. 3501et 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. 601et 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) (2 U.S.C. 1501et seq.).

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) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in theFederal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

On June 1, 2011, South Carolina made a submission to EPA requesting redesignation of the York County Area to attainment for the 1997 8-hour ozone NAAQS and approval of the South Carolina SIP revision containing a maintenance plan for the York County Area. In an action published on November 15, 2012 (77 FR 68087), EPA proposed approval of South Carolina's plan for maintaining the 1997 8-hour ozone NAAQS and the NOx and VOC MVEBs for the York County Area as contained in the maintenance plan. At that time, EPA also proposed to approve the redesignation of the York County Area to attainment.1 Additional background for today's action is set forth in EPA's November 15, 2012, proposal.

The MVEBs, specified in kilograms per day (kg/day), included in the maintenance plan are as follows:

In its November 15, 2012, proposed action, EPA noted that the adequacy public comment period on these MVEBs (as contained in South Carolina's submittal) began on October 28, 2011, and closed on November 28, 2011. No comments were received during the public comment period.

As stated in the November 15, 2012, proposal, this redesignation addresses the York County Area's status solely with respect to the 1997 8-hour ozone NAAQS, for which designations were finalized on April 30, 2004.See69 FR 23857. Effective July 20, 2012, EPA designated a portion of York County(excluding the Catawba Indian Nation reservation lands) as nonattainment for the 2008 8-hour ozone NAAQS. This rulemaking does not address requirements for the portion of York County that was designated nonattainment for the 2008 8-hour ozone NAAQS. Requirements for the portion of York County that was designated nonattainment for the 2008 8-hour ozone NAAQS will be addressed in the future.

EPA reviewed ozone monitoring data from ambient ozone monitoring stations in the bi-state Charlotte Area from 2009-2011. These data have been quality-assured and are recorded in Air Quality System (AQS). The 3-year average of the annual fourth highest daily maximum 8-hour average (i.e., design values) for 2008-2010 and 2009-2011 are summarized in Table 2. The design values demonstrate that the bi-state Charlotte Area continues to meet the 1997 8-hour ozone NAAQS. EPA has also reviewed preliminary monitoring data for 2012, which indicate that the bi-state Charlotte Area continues to attain the 1997 8-hour ozone NAAQS.

In today's rulemaking, EPA is approving: (1) South Carolina's 1997 8-hour ozone maintenance plan (such approval being one of the CAA criteria for redesignation to attainment status) for the York County Area, including MVEBs; and, (2) South Carolina's redesignation request to change the legal designation of the portion of York County in the bi-state Charlotte nonattainment area from nonattainment to attainment for the 1997 8-hour ozone NAAQS. The maintenance plan is designed to demonstrate that the York County Area (as part of the bi-state Charlotte Area) will continue to attain the 1997 8-hour ozone NAAQS through 2022. EPA's approval of the redesignation request is based on EPA's determination that South Carolina meets the criteria for the York County Area for redesignation set forth in CAA, sections 107(d)(3)(E) and 175A, including EPA's determination that the York County Area has attained the 1997 8-hour ozone NAAQS. EPA's analyses of South Carolina's redesignation request, and maintenance plan are described in detail in the November 15, 2012, proposed rule.See77 FR 68087. EPA did not receive any comments, adverse or otherwise, on the November 15, 2012, proposed rule to redesignate the South Carolina portion of the bi-state Charlotte Area to attainment for the 1997 8-hour ozone NAAQS.

Consistent with the CAA, the maintenance plan that EPA is approving also includes 2013 and 2022 MVEBs for NOXand VOC for the York County Area. In this action, EPA is approving these NOXand VOC MVEBs for the purposes of transportation conformity. For required regional emissions analysis years involving 2013 and prior to 2022, the applicable budgets will be the new 2013 MVEBs. For required regional emissions analysis years that involve 2022 or beyond, the applicable budgets will be the new 2022 MVEBs.

EPA has determined that the York County Area (as part of the bi-state Charlotte Area) has attained the 1997 8-hour ozone NAAQS and has also determined that all other criteria for the redesignation of the York County Area from nonattainment to attainment of the 1997 8-hour ozone NAAQS have been met.SeeCAA section 107(d)(3)(E). One of those requirements is that the York County Area has an approved plan demonstrating maintenance of the 1997 8-hour ozone NAAQS. EPA is also taking final action to approve the maintenance plan for the York County Area as meeting the requirements of sections 175A and 107(d)(3)(E) of the CAA. EPA is also approving the new NOXand VOC MVEBs for the years 2013 and 2022 as contained in South Carolina's maintenance plan for the York County Area because these MVEBs are consistent with maintenance of the 1997 8-hour ozone NAAQS in the Area. The detailed rationale for EPA's findings and actions are set forth in the November 15, 2012, proposed rulemaking and in other discussion in this final rulemaking.

Approval of the redesignation request changes the legal designation of the portion of York County in the bi-state Charlotte Area from nonattainment to attainment for the 1997 8-hour ozone NAAQS. EPA is modifying the regulatory table in 40 CFR 81.341 to reflect a designation of attainment for the county. EPA is also approving, as a revision to the South Carolina SIP, the State's plan for maintaining the 1997 8-hour ozone NAAQS in the York County Area through 2022. The maintenance plan includes contingency measures to remedy possible future violations of the 1997 8-hour ozone NAAQS, and establishes NOXand VOC MVEBs for the years 2013 and 2022 for the York County Area.

EPA is taking final action to approve the redesignation and change the legal designation of the portion of York County in bi-state Charlotte Area from nonattainment to attainment for the 1997 8-hour ozone NAAQS. Through this action, EPA is also approving into the South Carolina SIP the 1997 8-hour ozone maintenance plan for the York County Area, which includes for this Area the new NOXMVEB for 2013 and2022 for the York County Area of 11,272 kg/day and 11,368 kg/day, respectively. The VOC MVEB for 2013 and 2022 for the York County Area are 3,699 kg/day and 3,236 kg/day, respectively.

In accordance with 5 U.S.C. 553(d), EPA finds there is good cause for this action to become effective immediately upon publication. This is because a delayed effective date is unnecessary due to the nature of a redesignation to attainment, which relieves the Area from certain CAA requirements that would otherwise apply to it. The immediate effective date for this action is authorized under both 5 U.S.C. 553(d)(1), which provides that rulemaking actions may become effective less than 30 days after publication if the rule grants or recognizes an exemption or relieves a restriction, and section 553(d)(3), which allows an effective date less than 30 days after publication as otherwise provided by the agency for good cause found and published with the rule. The purpose of the 30-day waiting period prescribed in section 553(d) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. Today's rule, however, does not create any new regulatory requirements such that affected parties would need time to prepare before the rule takes effect. Rather, today's rule relieves the State of various requirements for the York County Area. For these reasons, EPA finds good cause under 5 U.S.C. 553(d)(3) for this action to become effective on the date of publication of this action.

Under the CAA, redesignation of an area to attainment and the accompanying approval of the maintenance plan under CAA section 107(d)(3)(E) are actions that affect the status of geographical area and do not impose any additional regulatory requirements on sources beyond those required by state law. A redesignation to attainment does not in and of itself impose any new requirements, but rather results in the application of requirements contained in the CAA for areas that have been redesignated to attainment. Moreover, 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 CAA. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by State law. For these reasons, these actions:

• Are 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);

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

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

• Do 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);

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

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

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

• Are 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,

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

In addition, the redesignation for the York County Area does have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because it may have substantial direct effects on the Catawba Indian Nation as the Tribe's reservation lands are within the York County Area for the 1997 8-hour ozone NAAQS. As such, today's final action to redesignate the York County Area to attainment for the 1997 8-hour ozone NAAQS includes the Catawba Indian Nation reservation lands. Accordingly, EPA and the Catawba Indian Nation consulted on this redesignation prior to today's final action. EPA's consultation on this and other ozone SIP matters for the York County Area with the Catawba Indian Nation commenced on October 14, 2011, and concluded on October 31, 2011. EPA further notes that today's action is not anticipated to impose substantial direct costs on Tribal governments or preempt Tribal law.

The Congressional Review Act, 5 U.S.C. 801et 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 theFederal Register. A major rule cannot take effect until 60 days after it is published in theFederal 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 February 25, 2013. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements.Seesection 307(b)(2).

40 CFR parts 52 and 81 are amended as follows:

As stated in EPA's proposed approval notice published on November 19, 2012 (77 FR 69409), this redesignation action addresses the Kentucky portion of the Huntington-Ashland Area's status solely with respect to the 1997 Annual PM2.5NAAQS, for which designations were finalized on November 13, 2009 (74 FR 58688). On February 12, 2012,1 the Commonwealth of Kentucky, through DAQ, submitted a request to redesignate the Kentucky portion of the Huntington-Ashland Area to attainment for the 1997 Annual PM2.5NAAQS, and for EPA approval of the Kentucky SIP revision containing a maintenance plan for the Area. In the November 19, 2012, notice, EPA proposed to take the following separate but related actions, some of which involve multiple elements: (1) To redesignate the Kentucky portion of the Huntington-Ashland Area to attainment for the 1997 Annual PM2.5NAAQS, and (2) to approve into the Kentucky SIP, under section 175A of the CAA, Kentucky's 1997 Annual PM2.5NAAQS maintenance plan, including the on-road motor vehicle insignificance finding for direct PM2.5and NOx for the Kentucky portion of the Huntington-Ashland Area. EPA received no comments, adverse or otherwise, on the November 19, 2012, proposed rulemaking. As noted in the November 19, 2012, proposal notice, on April 11, 2012, EPA approved, under section 172(c)(3) of the CAA, Kentucky's 2002 base-year emissions inventory for the Huntington-Ashland Area as part of the SIP revision submitted by the Commonwealth to provide for attainment of the 1997 p.m.2.5NAAQS in the Area. EPA received no comments, adverse or otherwise, on the proposal related to approval of Kentucky's 2002 base-year emissions inventory.

EPA is now taking final action on the three actions identified above. Additional background for today's action is set forth in EPA's November 19, 2012, proposal and is summarized below.

EPA has reviewed the most recent ambient monitoring data, which indicate that the Huntington-Ashland Area continues to attain the 1997 Annual PM2.5NAAQS beyond the submitted 3-year attainment period of 2008-2010. As stated in EPA's November 19, 2012, proposal notice, the 3-year design value of 13.1 μg/m3for 2008-2010 meets the NAAQS of 15.0 μg/m3. Quality assured and certified data in EPA's Air Quality System (AQS) for 2011 provide a 3-year design value of 12.1 μg/m3for 2009-2011. Furthermore, preliminary monitoring data for 2012 indicate that the Area is continuing to attain the 1997 Annual PM2.5NAAQS. The 2012 preliminary data are available AQS although not yet quality assured and certified.

In today's rulemaking, EPA is approving: (1) Kentucky's redesignation request to change the legal designation of Boyd County and a portion of Lawrence County in Kentucky from nonattainment to attainment for the 1997 Annual PM2.5NAAQS, and (2) Kentucky's 1997 Annual PM2.5maintenance plan (such approval being one of the CAA criteria for redesignation to attainment status) for the Kentucky portion of the Huntington-Ashland Area. The maintenance plan is designed to demonstrate that the Kentucky portion of the Huntington-Ashland Area will continue to attain the 1997 Annual PM2.5NAAQS through 2022. EPA's approval of the redesignation request is based on EPA's determination that the Kentucky portion of the Huntington-Ashland Area meets the criteria for redesignation set forth in CAA, sections 107(d)(3)(E) and 175A, including EPA's determination that the Kentucky portion of the Huntington-Ashland Area has attained the 1997 Annual PM2.5NAAQS. EPA's analyses of Kentucky's redesignation request, maintenance plan, and emissions inventory are described in detail in the November 19, 2012, proposed rule (77 FR 69409).

Consistent with the CAA, the maintenance plan that EPA is approving also includes an on-road motor vehicle insignificance finding for direct PM2.5and NOx for the Kentucky portion of the Huntington-Ashland Area. In this action, EPA is approving this insignificance finding for the purposes of transportation conformity.

EPA has determined that the Kentucky portion of the Huntington-Ashland Area has attained the 1997 Annual PM2.5NAAQS and has also determined that all other criteria for the redesignation of the Kentucky portion of the Huntington-Ashland Area from nonattainment to attainment of the 1997 Annual PM2.5NAAQS have been met.SeeCAA section 107(d)(3)(E). One of those requirements is that the Kentucky portion of the Huntington-Ashland Area has an approved plan demonstrating maintenance of the 1997 Annual PM2.5NAAQS. EPA is also taking final action to approve the maintenance plan for the Kentucky portion of the Huntington-Ashland Area as meeting the requirements of sections 175A and 107(d)(3)(E) of the CAA. In addition, EPA is approving the on-road motor vehicle insignificance finding for direct PM2.5and NOx for the Kentucky portion of the Huntington-Ashland Area. The detailed rationale for EPA's findings and actions are set forth in the proposed rulemaking and in other discussion in this final rulemaking.

Approval of the redesignation request changes the legal designation of Boyd County and a portion of Lawrence County in Kentucky from nonattainment to attainment for the 1997 Annual PM2.5NAAQS. EPA is modifying the regulatory table in 40 CFR 81.318 to reflect a designation of attainment for these counties. EPA is also approving, as a revision to the Kentucky SIP, the Commonwealth's plan for maintaining the 1997 Annual PM2.5NAAQS in the Kentucky portion of the Huntington-Ashland Area through 2022. The maintenance plan includes contingency measures to remedy possible future violations of the 1997 Annual PM2.5NAAQS and establishes an on-road motor vehicle insignificance finding for direct PM2.5and NOx for the Kentucky portion of the Huntington-Ashland Area.

EPA is taking final action to approve the redesignation and change the legal designation of Boyd County and a portion of Lawrence County in Kentucky from nonattainment to attainment for the 1997 Annual PM2.5NAAQS. Through this action, EPA is also approving into the Kentucky SIP the 1997Annual PM2.5maintenance plan for the Kentucky portion of the Huntington-Ashland Area, which includes an on-road motor vehicle insignificance finding for direct PM2.5and NOx for the Kentucky portion of the Huntington-Ashland Area.

In accordance with 5 U.S.C. 553(d), EPA finds there is good cause for this action to become effective immediately upon publication. This is because a delayed effective date is unnecessary due to the nature of a redesignation to attainment, which relieves the Area from certain CAA requirements that would otherwise apply to it. The immediate effective date for this action is authorized under both 5 U.S.C. 553(d)(1), which provides that rulemaking actions may become effective less than 30 days after publication if the rule grants or recognizes an exemption or relieves a restriction, and section 553(d)(3), which allows an effective date less than 30 days after publication as otherwise provided by the agency for good cause found and published with the rule. The purpose of the 30-day waiting period prescribed in section 553(d) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. Today's rule, however, does not create any new regulatory requirements such that affected parties would need time to prepare before the rule takes effect. Rather, today's rule relieves the Commonwealth of various requirements for the Kentucky portion of the Huntington-Ashland Area. For these reasons, EPA finds good cause under 5 U.S.C. 553(d)(3) for this action to become effective on the date of publication of this action.

Under the CAA, redesignation of an area to attainment and the accompanying approval of the maintenance plan under CAA section 107(d)(3)(E) are actions that affect the status of geographical area and do not impose any additional regulatory requirements on sources beyond those required by state law. A redesignation to attainment does not in and of itself impose any new requirements, but rather results in the application of requirements contained in the CAA for areas that have been redesignated to attainment. Moreover, 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 CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For these reasons, these actions:

• Are 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);

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

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

• Do 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);

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

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

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

• Are 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,

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

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

The Congressional Review Act, 5 U.S.C. 801et 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 theFederal Register. A major rule cannot take effect until 60 days after it is published in theFederal 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 February 25, 2013. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements.Seesection 307(b)(2).

40 CFR parts 52 and 81 are amended as follows:

EPA is issuing a final rule to amend provisions in the diesel sulfur fuel programs. The diesel sulfur amendments provide necessary flexibility for transmix processors and pipeline operators who produce locomotive and marine diesel fuel. EPA is taking this action under section 211 of the Clean Air Act.

The diesel transmix amendments will reinstate an allowance for transmix processors and pipeline operators to produce 500 ppm sulfur diesel fuel for use in older technology locomotive and marine diesel outside of the Northeast Mid-Atlantic (NEMA) Area and Alaskaafter 2014.1 These provisions were originally put in place as a necessary flexibility to address feasibility and cost issues associated with handling of the transmix volume generated in the pipeline distribution system. These provisions allowed the fuel distribution system to continue to function while transitioning to ULSD. The technology to economically reduce the sulfur content of transmix distillate product to 15 ppm at transmix processor and pipeline facilities did not exist, and any alternative measures of disposing of transmix were likewise deemed infeasible or cost prohibitive as the market was then configured. Thus, in order to implement the ULSD regulations, an outlet for the consumption of transmix distillate product was necessary. With no outlet, transmix would build up in storage tanks and pipelines would need to cease operations. When the ULSD standards were expanded to nonroad, locomotive, and marine (NRLM) diesel fuel, this would have removed the sole outlet in most areas of the country. Consequently, the transmix flexibility was finalized.

EPA's ocean-going vessels rule, however, removed this allowance beginning 2014 to streamline our ULSD compliance provisions and avoid additional complications that would otherwise result from adding a new stream of diesel, containing up to 1,000 ppm sulfur, for category 3 (C3) marine. EPA believed at the time that this new 1,000 ppm sulfur product could provide a suitable outlet for transmix distillate product. Thus, we believed that it was possible to remove the transmix flexibility. Transmix processors stated that they were not aware of the changes to the 500-ppm LM transmix provisions until after they were finalized, and that the C3 marine market would not be a viable outlet for their distillate product. Not only are most locations for refueling C3 marine vessels not located near transmix facilities, but C3 marine terminals also do not lend themselves easily to the receipt of small batches of transmix distillate product by tank truck. It might be possible over time to modify C3 terminals and fueling operations to receive transmix, but such changes were not within their control. Until such time, the locomotive and marine diesel market remained the only viable market.

On June 29, 2010, EPA received a petition from a group of transmix processors requesting that the Agency reconsider and reverse the 2014 sunset date for the 500-ppm LM transmix flexibility. Based on additional input that we received from transmix processors and other stakeholders in the fuel distribution system during our consideration of the petition, EPA believed that it would be appropriate to extend the 500-ppm diesel transmix flexibility for older locomotive and marine engines beyond 2014 for reasons discussed below. On October 9, 2012, EPA published in theFederal Registera Direct Final Rule (DFR) and parallel Notice of Proposed Rule (NPRM).2 The DFR and NPRM also included other provisions not relevant to this final rule. The DFR was withdrawn on this issue due to the receipt of a negative comment.3 Based on EPA's consideration of the comments on the NPRM, EPA is finalizing the proposal to extend the 500-ppm transmix flexibility outside of the NEMA area and Alaska beyond 2014.

In response to industry input, EPA also requested comments in the NPRM on whether the 500-ppm transmix flexibility should be extended to the NEMA area. Based on EPA's consideration of the comments we received, we are extending the transmix flexibility to within the NEMA area beginning with the effective date of this final rule.

Comments on the NPRM stated that the regulations did not provide adequate certainty that pipeline operators as well as transmix processors may produce 500 ppm LM from transmix. Based on these comments we are amending the regulations to provide clarity regarding EPA's long standing policy that pipeline operators as well as transmix processors may take advantage of the 500-ppm LM transmix flexibility.

The flexibilities promulgated in this rule will provide a feasible and cost effective means for the continued operation of the fuel distribution system under our ULSD program regulations as the locomotive and marine market transitions to equipment that require the use of ULSD and until such time as alternative methods of treatment or disposal for transmix can be developed. These amendments will impose no new direct costs or burdens on regulated entities beyond the minimal costs associated with reporting and recordkeeping requirements. These amendments will provide significant regulatory relief for transmix processors and pipeline operators to allow the petroleum distribution system to function efficiently while continuing to transition the market to virtually all ultra-low sulfur diesel fuel (ULSD,i.e.15 ppm sulfur diesel fuel) and the environmental benefits it provides.

Entities potentially affected by this action include those involved with the production, distribution and sale of diesel fuel. Regulated categories and entities affected by this action include:

HHS/CDC is publishing a DFR because it does not expect to receive any significant adverse comments and believes that updating definitions to add clarity to the regulations is non-controversial. However, in thisFederal Register, HHS/CDC is simultaneously publishing a companion notice of proposed rulemaking (NPRM) that proposes identical modifications. If HHS/CDC does not receive any significant adverse comments on this DFR within the specified comment period, we will publish a document in theFederal Registerconfirming the effective date of this final rule within 30 days after the comment period on the DFR ends and withdraw the NPRM. If HHS/CDC receives any timely significant adverse comment, we will withdraw the DFR in part or in whole by publication of a document in theFederal Registerwithin 30 days after the comment period ends. HHS/CDC will carefully consider all public comments received before proceeding with any subsequent final rule based on the NPRM. A significant adverse comment is one that explains: (1) Why the DFR is inappropriate, including challenges to the rule's underlying premise or approach; or (2) why the DFR will be ineffective or unacceptable without a change.

This preamble is organized as follows:

Interested persons are invited to participate in this rulemaking by submitting written views, opinions, recommendations, and data. Comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you do not wish to be disclosed publicly. Comments are invited on any topic related to this DFR.

The primary authority supporting this rulemaking is section 361 of the Public Health Service Act (42 U.S.C. 264). Section 361 authorizes the Secretary of HHS to make and enforce regulations as in the Secretary's judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the states or possessions of the United States and from one state or possession into any other state or possession. Regulations that implement federal quarantine authority are currently promulgated in 42 CFR Parts 70 and 71. Part 71 contains regulations to prevent the introduction, transmission, and spread of communicable diseases into the states and possessions of the United States, while Part 70 contains regulations to prevent the introduction, transmission, or spread of communicable diseases from one state into another. The Secretary has delegated to the Director of the Centers for Disease Control and Prevention the authority for implementing these regulations.

Authority for carrying out most of these functions has been delegated to HHS/CDC's Division of Global Migration and Quarantine (DGMQ). The Secretary's authority to apprehend, examine, detain, and conditionally release individuals is limited to those quarantinable communicable diseases published in an Executive Order of the President. This list currently includes cholera, diphtheria, infectious tuberculosis (TB), plague, smallpox, yellow fever, and viral hemorrhagic fevers, such as Marburg, Ebola, and Crimean-Congo hemorrhagic fever (CCHF), Severe Acute Respiratory Syndrome (SARS), and influenza caused by novel or re-emergent influenza viruses that are causing or have the potential to cause a pandemic (see Executive Order 13295, as amended by Executive Order 13375 on April 1, 2005).

Through this DFR, HHS/CDC is updating definitions to Part 70 to reflect modern science and current practices. HHS/CDC has chosen to publish a DFR because we view this as a non-controversial action and anticipate no significant adverse comment. This DFR does not create any additional requirements or burden upon the regulated community, nor does it affect the current practices of HHS/CDC. A significant adverse comment is one that explains: (1) Why the DFR is inappropriate, including challenges tothe rule's underlying premise or approach; or (2) why the DFR will be ineffective or unacceptable without a change. In determining whether a comment necessitates withdrawal of the DFR, HHS/CDC will consider whether it warrants a substantive response in a notice and comment process. If we receive significant adverse comment on this DFR, we will publish a timely withdrawal in theFederal Registerinforming the public that the amendment in this rule will not take effect. If this DFR is withdrawn, we will carefully consider all public comments before proceeding with any subsequent final rule based on the NPRM which is being published simultaneously in theFederal Register.

Regulations that implement federal authority for interstate quarantine are currently promulgated in 42 CFR part 70. The Secretary of HHS has delegated to the Director of the Centers for Disease Control and Prevention the authority for implementing 42 CFR part 70.

Through this DFR, HHS/CDC proposes to update the Definitions for 42 CFR part 70, under section 70.1, to reflect modern terminology and plain language commonly used by private sector industry and public health partners, as well as clarify the intent of the provisions that follow. Specifically, we are updating two existing definitions and adding eight new definitions to clarify existing provisions, as well as updating 70.6 to reflect the language of the most recent Executive Order concerning quarantinable communicable diseases.

Section 70.1(b) contains the definitions used in this DFR. The DFR proposes new or updated definitions to be consistent with modern quarantine concepts and current medical and public health principles and practice. Table 1 lists the current definitions found in 42 CFR part 70 and the definitions proposed in this DFR.

Possession.To best add clarity to part 70, we have updated the term “possession” to mean “U.S. Territory” and defined U.S. Territory to include American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands. Currently, only Puerto Rico and the Virgin Islands are explicitly listed in the definition. Thus, CDC is updating this provision to explicitly list the other U.S. jurisdictions to which this part applies.

State.To best add clarity to the regulations of part 70, specifically where roles and responsibilities are outlined, we have included a definition of “state” to mean any of the 50 states within the United States, plus the District of Columbia.

CDC.We have defined “CDC” to mean the Centers for Disease Control and Prevention within the Department of Health and Human Services to clarify the provisions under part 70.

Conditional release.We have defined “conditional release” to have the same meaning as “surveillance,” as that term is defined in 42 CFR Part 71. We have included this definition to best add clarity to the provisions and practices under part 70, specifically section 70.6, as well as to ensure that conditional release and surveillance are both used consistently in both parts 70 and 71.

Director.To clarify the provisions under part 70, we have defined “Director” to mean the Director, Centers for Disease Control and Prevention, Department of Health and Human Services, or another authorized representative as approved by the CDC Director or the Secretary of HHS.

Isolation.In this DFR, “isolation” is defined as the separation of an individual or group reasonably believed to be infected with a quarantinable communicable disease from those who are healthy to prevent the spread of the quarantinable communicable disease. This DFR clarifies the distinction between quarantine and isolation by separately defining “quarantine” and “isolation” to distinguish these common public health measures. Isolation, as currently used in 42 CFR 71.1, applies to both persons and groups of persons. Thus, CDC is changing the definition in part 70 so that the term is used consistently in both part 70 and 71. Applying isolation measures to groups of individuals is consistent with CDC's current practice and does not constitute a substantive change.

MasterorOperator.This DFR defines “Master” or “Operator” as the aircrew or sea crew member with responsibility respectively for aircraft or vessel operation and navigation or a similar individual with responsibility for a conveyance. We have included this definition to better identify and assign responsibilities under this subpart (according to current practices).

Quarantine.This DFR defines “quarantine” as the separation of an individual or group reasonably believed to have been exposed to a quarantinable communicable disease, but not yet ill,from others who have not been so exposed, to prevent the possible spread of the quarantinable communicable disease. In this DFR, HHS/CDC is separately defining quarantine and isolation to distinguish these common public health measures. Applying quarantine measures to groups of individuals is consistent with HHS/CDC's current practice and does not constitute a substantive change.

Quarantinable communicable disease.Under this DFR, “quarantinable communicable disease” means any of the communicable diseases listed in an Executive Order, as provided under section 361 of the Public Health Service Act (42 U.S.C. 264). Executive Order 13295, of April 4, 2003, as amended by Executive Order 13375 of April 1, 2005, contains the current revised list of quarantinable communicable diseases, and may be found athttp://www.cdc.gov/quarantineand in the docket as supplemental documents. If this Executive Order is amended, HHS/CDC will enforce the amended order immediately and update its Web site. The definition for “quarantinable communicable disease” is being added to Part 70 through this DFR to reflect the most recent Executive Order regarding quarantinable communicable disease. This addition does not reflect a substantive change from current practice.

U.S. Territory.Under this DFR, “U.S. Territory” means any territory (also known as possessions) of the United States including American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands. The Department of the Interior's Office of Insular Affairs, the federal government's cognizant agency for U.S. territories, no longer uses the term “possession” to refer to these jurisdictions. Consequently, HHS/CDC is adding a new definition for U.S. territory consistent with current federal usage.

Section 70.6,Apprehension and detention of persons with specific diseases,contains the general authority for the Director to take measures with respect to persons to protect the public's health against the spread of communicable diseases “listed in an Executive Order setting out a list of quarantinable communicable diseases, as provided under section 361(b) of the Public Health Service Act.” The current section 71.32(a) lists Executive Order 13295, of April 4, 2003. The subpart states that “If this Order is amended, HHS will enforce that amended order.” On April 1, 2005, this Executive Order was amended by Executive Order 13375. Therefore, as part of the non-controversial changes in this DFR, we are also updating section 70.6 to reflect the most recent amendment to the Executive Order which lists the “quarantinable communicable disease”, which we have also defined. These changes are not substantive and will not affect current practices.

Under Executive Order 13563 agencies are asked to consider all feasible alternatives to current practice and the rule as proposed. HHS/CDC notes that the main impact of this proposed rule is to update current definitions and clarify language in the current regulation to reflect modern terminology and plain language commonly used by global private sector industry and public health partners. The intent of these updates is to clarify the provisions of the existing regulation to help the regulated community comply with current regulation and protect public health. HHS/CDC believes that this rulemaking complies with the spirit of the Executive Order; updating current definitions, clarifying language, and updating the referenced Executive Order provides good alternatives to the current regulation.

Under Executive Order 12866 (EO 12866), Regulatory Planning and Review (58 FR 51735, October 4, 1993) HHS/CDC is required to determine whether this regulatory action would be “significant” and therefore subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Orders. This order defines “significant regulatory action” as any regulatory action that is likely to result in a rule that may:

Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities;

Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients; or,

Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in E.O. 12866.

Executive Order 13563 (E.O. 13563), Improving Regulation and Regulatory Review, (76 FR 3821, January 21, 2011), updates some of the provisions of E.O. 12866 in order to promote more streamlined regulatory actions. This E.O. charges, in part, that, while protecting “public health, welfare, safety, and our environment” that regulations must also “promote predictability and reduce uncertainty” in order to promote economic growth. Further, regulations must be written in common language and be easy to understand. In the spirit of E.O. 13563, this DFR enhances definitions related to the control of communicable diseases and add more current medical terminology where appropriate.

HHS/CDC has determined that this DFR is simply an update and clarification of definitions and terms used in the current regulation. As such, the DFR complies with the spirit of E.O. 13563. Further, HHS/CDC has determined that this DFR is not a significant regulatory action as defined in E.O. 12866 because the DFR is definitional and does not change the baseline costs for any of the primary stakeholders.

We have examined the impacts of the rule under the Regulatory Flexibility Act (5 U.S.C. 601-612). Unless we certify that the rule is not expected to have a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), requires agencies to analyze regulatory options that would minimize any significant economic impact of a rule on small entities. We certify that this rule will not have a significant economic impact on a substantial number of small entities within the meaning of the RFA.

This DFR is not a major rule as defined by Sec. 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in cost or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

HHS/CDC has already determined that the Paperwork Reduction Act applies to the data collection and record keeping requirements of 42 CFR part 70 and has obtained approval by the Office of Management and Budget (OMB) to collect data and require record keeping under OMB Control No. 0920-0488, expiration 03/31/2013. The changes in this rule do not impact the data collection or record keeping requirements and do not require revision to the approval from OMB.

Pursuant to 48 FR 9374 (list of HHS/CDC program actions that are categorically excluded from the NEPA environmental review process), HHS/CDC has determined that this action does not qualify for a categorical exclusion. In the absence of an applicable categorical exclusion, the Director, CDC, has determined that provisions amending 42 CFR part 70 will not have a significant impact on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under this rule: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.

HHS/CDC has reviewed this rule in accordance with Executive Order 13132 regarding Federalism, and has determined that it does not have “federalism implications.” The rule does not “have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

Under Public Law 111-274 (October 13, 2010), executive Departments and Agencies are required to use plain language in documents that explain to the public how to comply with a requirement the Federal Government administers or enforces. HHS/CDC has attempted to use plain language in promulgating this rule consistent with the Federal Plain Writing Act and requests public comment on this effort.

For the reasons discussed in the preamble, the Centers for Disease Control and Prevention amends 42 CFR part 70 as follows:

HHS/CDC is publishing a direct final rule (DFR) because it does not expect to receive any significant adverse comments and believes that updating scope and definitions to add clarity to the regulations is non-controversial. However, in thisFederal Register,HHS/CDC is simultaneously publishing a companion notice of proposed rulemaking (NPRM) that proposes identical updates. If HHS/CDC does not receive any significant adverse comments on this DFR within the specified comment period, we will publish a document in theFederal Registerconfirming the effective date of this final rule within 30 days after the comment period on the DFR ends and withdraw the NPRM. If HHS/CDC receives any timely significant adverse comment, we will withdraw the DFR in part or in whole by publication of a document in theFederal Registerwithin 30 days after the public comment period ends. If the DFR is withdrawn, we will carefully consider all public comments before proceeding with any subsequent final rule based on the NPRM. A significant adverse comment is one that explains: (1) Why the DFR is inappropriate, including challenges to the rule's underlying premise or approach; or (2) why the DFR will be ineffective or unacceptable without a change.

This preamble is organized as follows:

Interested persons are invited to participate in this rulemaking by submitting written views, opinions, recommendations, and data. Comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you do not wish to be disclosed publicly. Comments are invited on any topic related to this DFR.

The primary authority supporting this rulemaking is section 361 of the Public Health Service Act (42 U.S.C. 264). Section 361 authorizes the Secretary of HHS to make and enforce regulations as in the Secretary's judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the states or possessions of the United States and from one state or possession into any other state or possession. Regulations that implement federal quarantine authority are currently promulgated in 42 CFR Parts 70 and 71. Part 71 contains regulations to prevent the introduction, transmission, and spread of communicable diseases into the states and possessions of the United States, while Part 70 contains regulations toprevent the introduction, transmission, or spread of communicable diseases from one state into another. CDC is updating the term “possession” to “territory.” The U.S. Department of the Interior's Office of Insular Affairs, the lead federal agency on issues involving the territories, no longer uses the term “possession” to refer to the insular areas. Therefore, CDC is adopting the predominant term “territory” consistent with how other federal agencies use this term. The Secretary has delegated to the Director of the Centers for Disease Control and Prevention the authority for implementing these regulations.

Authority for carrying out most of these functions has been delegated to HHS/CDC's Division of Global Migration and Quarantine (DGMQ). The Secretary's authority to apprehend, examine, detain, and conditionally release individuals is limited to those quarantinable communicable diseases published in an Executive Order of the President. This list currently includes cholera, diphtheria, infectious tuberculosis (TB), plague, smallpox, yellow fever, and viral hemorrhagic fevers, such as Marburg, Ebola, and Crimean-Congo hemorrhagic fever (CCHF), Severe Acute Respiratory Syndrome (SARS), and influenza caused by novel or re-emergent influenza viruses that are causing or have the potential to cause a pandemic (see Executive Order 13295, as amended by Executive Order 13375 on April 1, 2005).

Through this Direct Final Rule (DFR), HHS/CDC is updating the scope and definitions to part 71 to reflect modern science and current practices. HHS/CDC has chosen to publish a DFR because we view this as a non-controversial action and anticipate no significant adverse comment. This DFR does not create any additional requirements or burden upon the regulated community nor does it alter current HHS/CDC practices.

A significant adverse comment is one that explains: (1) Why the DFR is inappropriate, including challenges to the rule's underlying premise or approach; or (2) why the DFR will be ineffective or unacceptable without a change. In determining whether a comment necessitates withdrawal of this DFR, HHS/CDC will consider whether it warrants a substantive response through a notice and comment process. If we receive significant adverse comment on this DFR, we will publish a timely withdrawal in theFederal Registerinforming the public that the amendments in this rule will not take effect. If this DFR is withdrawn, we will carefully consider all public comments before proceeding with any subsequent final rule based on the NPRM which is being published simultaneously in theFederal Register.

Through this DFR, HHS/CDC is updating the Scope and Definitions for 42 CFR Part 71 under section 71.1 and adding a new section 71.50, to reflect modern terminology and plain language commonly used by global private sector industry and public health partners. Specifically, we are updating five existing definitions, adding thirteen new definitions to help clarify existing provisions, and creating a new scope and definitions section within Part 71, under subpart F for Importations, by reorganizing certain existing definitions. In updating the definitions in Part 71, it became evident to us that certain definitions pertain more directly toImportationsunder subpart F than to Part 71 in general; therefore, we decided to reorganize the existing definitions by creating a new section 71.50 for this subpart to better clarify these terms for importers. We are also adding new definitions that have been crafted for section 71.50 to help clarify the intent of certain provisions under subpart F.

Finally, as part of the changes to definitions, we are also updating section 71.32(a) to incorporate the most recent listing of quarantinable communicable diseases under Executive Order 13295, of April 4, 2003, as amended by Executive Order 13375 of April 1, 2005. These changes are not substantive and will not affect current practices.

Section 71.1(a) has been updated to include the current interstate quarantine regulations administered by HHS/CDC found at “42 CFR part 70” to the existing cross-reference citing “21 CFR parts 1240 and 1250.”

On August 16, 2000, the Secretary transferred certain authority for interstate control of communicable disease, including the authority to apprehend, examine, detain, and conditionally release individuals moving from one state into another from HHS/Food and Drug Administration (FDA) to CDC, which became 42 CFR Part 70. As part of this transfer, FDA retained regulatory authority over animals and other products that may transmit or spread communicable disease. These other regulations may be found at 21 CFR parts 1240 and 1250. This rule has no effect upon FDA's regulatory authority. Accordingly, the new scope will read: “The provisions of this part contain the regulations to prevent the introduction, transmission, and spread of communicable disease from foreign countries into the States or territories (also known as possessions) of the United States. Regulations pertaining to preventing the interstate spread of communicable diseases are contained in 21 CFR parts 1240 and 1250 and42 CFR part 70.”

Current section 71.1 (b)Definitionscontains definitions used in the current CFR. This DFR adds new definitions and updates certain definitions for clarification and to be consistent with current industry and public health principles and practice.

Table 1 list the definitions found in the current 42 CFR part 71, subpart A, and compares them with the updated definitions in this DFR.

International Health Regulations or IHR.This DFR defines International Health Regulations or IHR as the International Health Regulations of the World Health Organization (WHO), adopted by the 58th World Health Assembly in 2005, as may be further amended, and subject to the United States' reservation and understandings. The DFR updates the current CFR's definition to reflect that the 1969 IHR, as amended in 1973 and 1981 by the World Health Assembly, has been superseded by the 2005 IHR currently in place. This definition also reflects that the United States accepted the IHR with the reservation that it will implement them in line with U.S. principles of federalism. In addition, the United States submitted three understandings, setting forth its views that: (1) Incidents that involve the natural, accidental or deliberate release of chemical, biological or radiological materials are notifiable under the IHR; (2) countries that accept the IHR are obligated to report potential public health emergencies that occur outside their borders to the extent possible; and (3) the IHR do not create any separate private right to legal action against the federal government.

Isolation.The DFR defines the term “isolation” as the separation of an individual or group of individuals who are reasonably believed to be infected with a quarantinable communicable disease from others who are healthy in such a manner as to prevent the spread of the quarantinable communicable disease. The current definition of “isolation,” when applied to an individual or group of individuals, is stated as “the separation of that person or group of persons from other persons, except the health staff on duty, in such a manner as to prevent the spread of infection.” Not only does the updated definition help to clarify the distinction between quarantine and isolation, but it removes the current reference to “health staff on duty” to which the separation does not apply. HHS/CDC believes that the reference to “health staff on duty” is unnecessary and outmoded because, in practice, a patient may have his or her needs attended to by a variety of individuals. The new definition focuses on the measures used to prevent the spread of infection and not on the types of individuals who may attend to the patient. This is not a substantive change from current practice.

Surveillance.Under this DFR, “surveillance” is defined as the temporary supervision by a public health official (or designee) of an individual or group, who may have been exposed to a quarantinable communicable disease, to determine the risk of disease spread. We have updated the term “surveillance” to more accurately reflect current practice and to clarify that, just as with quarantine and isolation, this public health measure is applicable to individuals and groups of individuals.

United States.We have updated the definition of “United States” to mean the 50 States, the District of Columbia, and the territories (also known as possessions) of the United States, including American Samoa, Guam, the Northern Mariana Islands, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands. We have taken this action to better clarify the authority of provisions within Part 71. The current definition includes the Trust Territory of the Pacific Islands, which have not been administered by the United States since 1986.

Vector.We have updated the term “vector” to be defined as any animals (vertebrate or invertebrate) including arthropods or any noninfectious self-replicating system (e.g., plasmids or other molecular vector) or animal products that are known to transfer, or are capable of transferring, an infectious biological agent to a human. To provide further clarity, we have defined the term “animal products” in subpart F. This revision more adequately reflects modern science and current practice which are focused on protecting public health.

Commander.Consistent with current industry practice, this DFR defines “commander” as the aircrew member with responsibility for the aircraft's operations and navigation.

Quarantine.“Quarantine” is defined as the separation of an individual or group of individuals who are reasonably believed to have been exposed to a quarantinable communicable disease, but who are not yet ill, from others who have not been so exposed, in such a manner as to prevent the possible spread of the quarantinable communicable disease. HHS/CDC is separately defining quarantine, isolation, and surveillance, and is using these terms in a manner that is consistent with public health practice. In current practice, quarantine, isolation, and surveillance may apply either to individuals or groups of individuals. Indeed, the current definition of Isolation in 42 CFR 71.1applies to “a person or group of persons.” HHS/CDC is clarifying that quarantine and surveillance are public health practices that may also be applied to groups of individuals. This is not a substantive change, but rather consistent with CDC's current practice.

Quarantinable communicable disease.“Quarantinable communicable disease” is defined as any of the communicable diseases listed in an Executive Order, as provided under section 361 of the Public Health Service Act (42 U.S.C. 264). Executive Order 13295, of April 4, 2003, as amended by Executive Order 13375 of April 1, 2005, contains the current revised list of quarantinable communicable diseases, and may be obtained athttp://www.cdc.govandhttp://www.archives.gov/federal_register.If this Order is amended, HHS will enforce that amended order immediately and update the appropriate Web site. A new definition for “quarantinable communicable disease” is being added to part 71 through this DFR to incorporate the most recent Executive Order. The addition of this new definition will also be reflected in section 71.32(a),Persons, carriers and things.

Possession.To best add clarity to part 71 and to align this part with 42 CFR part 70, we have updated the term “possession” to mean “U.S. territory” and defined U.S. territory to include American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands. Currently, only Puerto Rico and the Virgin Islands are explicitly listed in the definition. Thus, CDC is updating this provision to explicitly list the other U.S. jurisdictions to which this part applies.

U.S. territory.Under this DFR, “U.S. territory” means any territory (also known as possessions) of the United States including American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands. The Department of the Interior's Office of Insular Affairs, the federal government's lead agency for U.S. territories, no longer uses the term “possession” to refer to these jurisdictions. Consequently, HHS/CDC is adding a new definition for U.S. territory consistent with current federal usage.

In 2003, in response to the emergence of Severe Acute Respiratory Syndrome (SARS), HHS amended 42 CFR 70.6 and 71.32 to incorporate by reference the Executive Order listing the quarantinable communicable diseases subject to detention, isolation, quarantine, or conditional release, thereby eliminating the administrative delay involved in separately publishing the list of diseases through rulemaking.

Section 71.32(a),Persons, carriers, and things,contains the general authority for the Director to take measures to protect public health against “any of the communicable diseases listed in an Executive Order, as provided under section 361(b) of the Public Health Service Act.” The current § 71.32(a) lists Executive Order (E.O.) 13295, of April 4, 2003. The subpart states that “If this Order is amended, HHS will enforce that amended order.”

On April 1, 2005, the existing Executive Order was amended by Executive Order 13375. Therefore, as part of the non-controversial changes in this DFR, we are also updating section 71.32(a) to reflect the most recent Executive Order that lists the “Quarantinable Communicable Diseases,” which we have also defined. These changes are not substantive and will not affect current practices.

This DFR moves certain definitions from section 71.1 to new section 71.50, because these definitions only apply to the regulations found in subpart F,Importations.Subpart F,Importations,contains the restrictions on importations of nonhuman primates; certain kinds of animals; etiological agents, hosts, and vectors; and dead bodies. The addition of § 71.50 Scope and Definitions is not a substantive change. To clarify the regulations for the reader, the terms used only in subpart A through subpart G are found in § 71.1, while the terms used only in subpart F, have been moved to new § 71.50. We have also separated definitions for quarantine and isolation to reflect current practices as they apply to individuals (§ 71.1) and animals (§ 71.50).

Section 71.50(a)Scopeunder subpart F—Importations,clarifies that HHS/CDC also has the statutory authority to prevent the introduction, transmission, and spread of communicable human diseases resulting from importations of various animal hosts, product, vectors, or other etiological agents that pose a threat to human health.

Section 71.50(b)Definitionscontains updated definitions used in the current CFR. The DFR promulgates new and updated definitions to be consistent with current medical and public health principles and practice.

Table 2 lists the definitions found in the 42 CFR part 71, subpart A, prior to the DFR and the definitions retained in this final rule.

Animal Product or Product.We have defined the term “animal product” or “product” to describe those items that are known to transfer, or are capable of transferring, an infectious biological agent to a human and that are prohibited from entering the United States unless accompanied by a permitor rendered noninfectious. For the purposes of this DFR, “animal product” or “product” means the hide, hair, skull, teeth, bones, claws, blood, tissue, or other biological samples from an animal, including trophies, mounts, rugs, or other display items. We have added this definition, which is used in subpart F, to best describe the current prohibition on animal products that are known to transfer, or are capable of transferring, an infectious biological agent to a human and that as a condition of entry into the United States must be accompanied by a permit or rendered noninfectious.

In transit.In this DFR, we have defined “in transit” as animals that are located within the United States, including animals whose presence is anticipated, scheduled, or otherwise, as part of the movement of those animals between a foreign country of departure and foreign country of final destination without clearing customs and officially entering the United States. As part of modern global trade and travel practices, animals commonly pass through the United States without being formally admitted into this country. These animals pose a potential risk to U.S. public health where the improper handling of these shipments during exchange of cargo could introduce zoonotic diseases into the United States. We note that the term “in-transit” is currently only found in section 71.51 relating to the importation of dogs and cats and we believe it is useful to add clarity to this section by defining what is meant by this term.

Isolation, when applied to animals.To distinguish the concept of isolation for individuals from isolation of animals, we have defined “isolation” under this subpart to mean the separation of an ill animal or ill group of animals from individuals, other animals, or vectors of disease in such a manner as to prevent the spread of infection.

Licensed Veterinarian.We have defined “licensed veterinarian” to mean an individual who has obtained both an advanced degree and a valid license to practice animal medicine. This new definition best describes the intent of provisions of this subpart.

Person.We have defined “person” to mean any individual or partnership, firm, company, corporation, association, organization, or similar legal entity, including those that are not-for-profit. With the exception of 42 C.F.R. section 71.55, which refers to the imported remains of a natural person, this definition is intended to clarify the relevant import prohibitions applicable to individuals and organizations under this subpart.

Quarantine, when applied to animals.We have defined “quarantine” as it applies to animals as the practice of separating live animals that are reasonably believed to have been exposed to a communicable disease, but are not yet ill, in a setting where the animal can be observed for evidence of disease, and where measures are in place to prevent transmission of infection to humans or animals. This new definition best clarifies the current public health measure of quarantining animals, and it distinguishes it from public health practice of isolation when applied to animals.

Render Noninfectious.For purposes of this DFR, to “render noninfectious” means “treating an animal product (e.g., by boiling, irradiating, soaking, formalin fixation, or salting) in such a manner that renders the product incapable of transferring an infectious biological agent to a human.”

Acceptable methods of rendering a product noninfectious typically include the following:

(1) Boiling in water to ensure that any matter other than bone, horns, hooves, claws, antlers, or teeth is removed,

(2) Irradiating with gamma irradiation at a dose of at least 20 kilogray at room temperature (20° C or higher),

(3) Soaking, with agitation, in a 4 percent (weight/volume) solution of washing soda (sodium carbonate, Na2CO3) maintained at pH 11.5 or above for at least 48 hours,

(4) Soaking, with agitation, in a formic acid solution (100 kg salt [sodium chloride, NaCl] and 12 kg formic acid per 1,000 liters water) maintained at below pH 3.0 for at least 48 hours; wetting and dressing agents may be added.

(5) In the case of raw hides, salting for at least 28 days with sea salt containing 2 percent washing soda (sodium carbonate, Na2CO3).

(6) Formalin fixation.

(7) Another method approved by HHS/CDC.

Through this definition within the DFR, HHS/CDC is better clarifying and explaining existing practices that limit the importation of animal products that are known to transfer, or are capable of transferring, an infectious biological agent to a human. Such products must be accompanied by an HHS/CDC import permit or rendered noninfectious as a condition of entry into the United States. Items that have been rendered noninfectious, as described in this subpart, may be imported without an HHS/CDC permit.

Youoryour.To best identify and assign responsibilities under this subpart, we have defined the terms “you” or “your” to mean an importer, owner, or an applicant.

Under Executive Order 13563 agencies are asked to consider all feasible alternatives to current practice and the rulemaking. HHS/CDC notes that the main impact of the DFR is to clarify the current practices and intent of HHS/CDC by updating and defining terms used in the existing 42 CFR Part 71. As explained in Section III. “Rationale for Updates to 42 CFR 71.1, 71.32(a) and 71.50,” through this DFR, HHS/CDC is also updating the Scope and Definitions for 42 CFR Part 71 under sections 71.1 and add new section 71.50, to reflect modern terminology and plain language commonly used by global private sector industry and public health partners. By clarifying and explaining the provisions within part 71, HHS/CDC hopes to assist the regulated community in complying with the provisions to best protect public health. HHS/CDC believes that this rulemaking complies with the spirit of the Executive Order; updating definition and clarifying language provides good alternatives to the current regulation.

Under Executive Order 12866 (EO 12866), Regulatory Planning and Review (58 FR 51735, October 4, 1993) CDC is required to determine whether this regulatory action would be “significant” and therefore subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Orders. This order defines “significant regulatory action” as any regulatory action that is likely to result in a rule that may:

• Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities;

• Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

• Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients; or,

• Raise novel legal or policy issues arising out of legal mandates, thePresident's priorities, or the principles set forth in EO 12866.

Executive Order 13563 (EO 13563), Improving Regulation and Regulatory Review, (76 FR 3821, January 21, 2011), updates some of the provisions of EO 12866 in order to promote more streamlined regulatory actions. This EO charges, in part, that, while protecting “public health, welfare, safety, and our environment” that regulations must also “promote predictability and reduce uncertainty” in order to promote economic growth. Further, regulations must be written in common language and be easy to understand. In the spirit of EO 13563, this DFR enhances definitions related to control of communicable diseases and adds more recent medical information where appropriate. CDC has determined that this DFR is an update of definitions and compliant with the spirit of EO 13563. Further, CDC has determined that this DFR is not a significant regulatory action as defined in EO 12866 because the DFR is definitional and does not change the baseline costs for any of the primary stakeholders.

We have examined the impacts of the rule under the Regulatory Flexibility Act (5 U.S.C. 601-612). Unless we certify that the rule is not expected to have a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), requires agencies to analyze regulatory options that would minimize any significant economic impact of a rule on small entities. We certify that this rule will not have a significant economic impact on a substantial number of small entities within the meaning of the RFA.

This regulatory action is not a major rule as defined by Sec. 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in cost or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

HHS/CDC has determined that the Paperwork Reduction Act does apply to the date collection and record keeping requirements of 42 CFR Part 71 and has obtained approval by the Office of Management and Budget (OMB) under OMB Control No. 0920-0134, expiration 07/31/2015. The updates in this rule do not impact the data collection and record keeping requirements already approved by OMB.

Pursuant to 48 FR 9374 (list of HHS/CDC program actions that are categorically excluded from the NEPA environmental review process), HHS/CDC has determined that this action does not qualify for a categorical exclusion. In the absence of an applicable categorical exclusion, the Director, HHS/CDC, has determined that provisions amending 42 CFR Part 71 will not have a significant impact on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under this rule: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.

HHS/CDC has reviewed this rule in accordance with Executive Order 13132 regarding Federalism, and has determined that it does not have “federalism implications.” The rule does not “have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

Under Public Law 111-274 (October 13, 2010), executive Departments and Agencies are required to use plain language in documents that explain to the public how to comply with a requirement the Federal Government administers or enforces. HHS/CDC has attempted to use plain language in promulgating this rule consistent with the Federal Plain Writing Act and requests public comment on this effort.

For the reasons discussed in the preamble, the Centers for Disease Control and Prevention amends 42 CFR part 71 as follows:

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 theFederal 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. 3501et seq.

Accordingly, 44 CFR Part 64 is amended as follows:

This is a summary of the Commission's Order on Reconsideration in CG Docket No. 03-123, WC Docket Nos. 05-196, 10-191, FCC 12-139, released on November 16, 2012. The full text of this document is available for public inspection during regular business hours in the FCC Reference Center, Room CY-A257, 445 12th Street SW., Washington, DC 20554. It is also available on the Commission's Web site athttp://www.fcc.gov.

1. In this Order, we grant in part a petition for reconsideration and clarification of the Commission'siTRS Toll Free Order,76 FR 59551, September 27, 2011 filed by Sorenson Communications, Inc. (Sorenson). In thatOrder,the Commission adopted rules to improve assignment of telephone numbers associated with Internet-based Telecommunications Relay Service (iTRS). For the reasons set forth below, the Commission grants Sorenson's Petition with respect to certain user notification requirements and denies the remainder of the Petition.

2. Prior to 2008, there was no uniform numbering system for iTRS services; some iTRS users were reached via an IP address, while others were reached via toll free numbers. Because iTRS providers did not share their databases, the lack of standardized numbering hindered calls between people using different iTRS services. The widespread use of toll free numbers created additional competitive concerns because the users could not take their telephone numbers with them if they switched providers.

3. To address these concerns, beginning in 2008 the Commission adopted a series of orders that discouraged iTRS providers from issuing toll free numbers to their users. Ultimately, in theiTRS Toll Free Order,the Commission prohibited iTRS providers from issuing toll free numbers, requiring them instead to issue only geographically appropriate, ten-digit, North American Numbering Plan (NANP) telephone numbers. The Commission took this action because, in addition to the competitive concerns described above, the routine issuance of toll free numbers confused iTRS users, undermined the Commission's number conservation policy, increased costs to the TRS Fund, and potentially hindered responses to 911 calls.

4. Historically, when an iTRS user had a toll free number, the iTRS provider was the subscriber of record for that number; the user did not have a direct relationship with the toll free service provider. Under the rules the Commission adopted in theiTRS Toll Free Order,however, the iTRS user must be the toll free service provider's subscriber of record and must pay for the toll free subscription. TheOrderrequires iTRS providers to facilitate this transition in various ways, notably by ensuring that iTRS users' toll free numbers are properly mapped in the TRS Numbering Directory (the numbering database used for iTRS services) and by explaining to users how they may keep or acquire a toll free number. TheOrderestablished a one-year transition period for iTRS providers to implement the new rules; the transition period ends on November 21, 2012.

5. In October 2011, Sorenson filed a petition seeking reconsideration and clarification of specific aspects of theiTRS Toll Free Order.Sorenson challenges aspects of the database mapping requirement and the customer notification requirement. No party opposed Sorenson's Petition, and one party—Hamilton Relay—filed in support.

6. TheiTRS Toll Free Orderrequires iTRS providers to ensure that when an iTRS subscriber obtains a toll free number, that toll free number is properly mapped to that subscriber's NANP geographic number in the TRS Numbering Directory. The user's toll free number must be associated with the same Uniform Resource Identifier (URI) as that user's geographically appropriate NANP number in the TRS Numbering Directory.

7. Sorenson asks the Commission to reconsider this requirement, arguing that iTRS providers should not be required to map an iTRS user's toll free number to the user's URI in the TRS Numbering Directory. Sorenson claims that, because iTRS providers will no longer provision toll free numbers under the new rules, they will be unable to ensure that the information they receive about a number is accurate. Sorenson also claims that it will be unable to identify potential mistakes or changes when mapping a toll free number to the user's URI, such as if a user chooses to disconnect a toll free number and does not notify the iTRS provider. Sorenson further claims that mistakes in mapping will result in call failures due to database errors, and that the rules may enable fraud and spoofing by iTRS users. Sorenson argues that the Commission should consider alternative approaches. Specifically, Sorenson proposes that the Commission either (1) sever any connection between an iTRS user's toll free number and the TRS Numbering Directory, or (2) require another entity (not the iTRS provider) to verify that the toll free numbers and mappings are valid.

8. We deny Sorenson's Petition in this respect and decline to reconsider the database mapping requirements in theiTRS Toll Free Order.We do not find that Sorenson's concerns about linking a toll free number to an iTRS user's URI in the TRS Numbering Directory warrant a change to the current rules; nor do we find that Sorenson's proposed alternatives constitute a better approach.

9. As an initial matter, we note that the Commission addressed Sorenson'sconcerns about database accuracy in theiTRS Toll Free Order.Sorenson raised the issue in its comments on theiTRS Toll Free Notice,75 FR 67333, November 2, 2010, and the Commission responded in theOrder,saying, “If Sorenson expects such errors to occur, it—and all other iTRS providers—may notify the iTRS user of the potential mistake and make several verifications of the toll free number to ensure correctness.” Sorenson argues in its Petition that, notwithstanding the language in theOrder,Sorenson will have no way to verify whether the information it receives from its users about toll free numbers is accurate. We continue to believe, however, that iTRS providers do have ways to verify that toll free numbers have been mapped accurately, including by simply calling a toll free number to ensure that the call is delivered to the user. We do not believe that verifying database accuracy will be an overly burdensome task for providers because we expect that the number of iTRS users who choose to maintain or obtain toll free numbers under the new rules will be small. Most iTRS users will choose to relinquish their toll free numbers rather than pay for them. Thus, we expect that only a small number of iTRS users will require their iTRS provider to input a toll free number into the TRS Numbering Directory.

10. Second, the mapping requirement is essential in order to ensure that deaf and hard-of-hearing users' access to and use of toll free numbers are functionally equivalent to hearing users' access to and use of toll free numbers. Sorenson's suggestion that the Commission eliminate the requirement entirely and keep toll free numbers out of the TRS Numbering Directory would undermine this goal. Information in the TRS Numbering Directory is used to route NANP-dialed calls both between deaf and hearing persons via a relay service and also directly between two deaf persons without the intervention of a relay service (point-to-point calls). As Sorenson acknowledges, its proposed approach would make point-to-point video calls to toll free numbers impossible, so that a deaf person could not call another deaf person's toll free number directly. The Commission has previously emphasized the importance of point-to-point video calling to iTRS users, and we decline to restrict that functionality in this manner.

11. Third, the responsibility for ensuring accurate database mapping should lie with the iTRS provider because it serves as the registered service provider to its customers, and thus is already responsible for entering its customers' information into the TRS Numbering Directory. Shifting the responsibility to another party, as Sorenson proposes, is undesirable because under both the Commission's rules and the directory access parameters set up by the database administrator, only iTRS providers may enter and change directory records, and only an individual's default provider may enter and change information for that individual. Moreover, shifting responsibility to a third party with no access to the TRS Numbering Directory and no relationship with the user would likely increase, not decrease, the chance of database errors.

12. Finally, we find that Sorenson's concerns about fraud and spoofing are overstated. As noted above, we expect the number of iTRS users who choose to retain, and pay for, toll free numbers to be small. Furthermore, the nature of iTRS services makes them poor vehicles for fraud and spoofing. Any iTRS user who tried to spoof a toll free number would necessarily have it linked to both his ten-digit number and his IP address, making it relatively traceable (unlike conventional PSTN spoofing scenarios), and thus an unlikely choice for perpetrating fraud. VRS is particularly well-protected: If a VRS user dialed a spoofed toll free number that had made its way into the TRS Numbering Directory, the VRS provider would identify the call as a point-to-point call between two deaf users, and the caller would end up face to face with the perpetrator. We therefore believe that the rules are unlikely to facilitate or lead to widespread fraud and spoofing schemes by iTRS users. Our decision here rests on two predictive judgments: That verifying the accuracy of the iTRS Directory with respect to toll free numbers will not be unduly burdensome on iTRS providers and that fraud and spoofing will not become major problems. We note that if either of our predictive judgments turn out incorrect, we remain free to consider alternative solutions to address these issues while ensuring the continuing integrity of point-to-point calls between iTRS users.

13. For these reasons, the Commission denies Sorenson's request for reconsideration of the database mapping requirements. We also deny Sorenson's request for “clarification that the Commission is aware of the problems that may result from the approach reflected in the Order and will not hold iTRS providers responsible for such problems over which they have no control.” As we have explained, we disagree that providers have “no control” over the information about toll free numbers in the TRS Numbering Directory, and the Commission has rejected claims that iTRS providers lack the ability to verify the accuracy of toll free numbers. Thus, we reiterate that iTRS providers must take reasonable measures to ensure the completeness and accuracy of their users' records in the TRS Numbering Directory.

14. TheiTRS Toll Free Orderrequires iTRS providers to include, in any promotional materials addressing numbering or E911 services, information about (1) the process by which an iTRS user may acquire a toll free number or transfer control of a toll free number from a VRS or IP Relay provider to the user; and (2) the process by which a user may request that the toll free number be linked to his or her ten-digit telephone number in the TRS Numbering Directory (by their iTRS provider). The information provided must include contact information for toll free service providers.

15. Sorenson requests reconsideration or clarification of the customer notification requirements in three respects. First, Sorenson argues that the notification requirements are unnecessarily burdensome, and that the volume of information that they would have to provide under the rule would fill more than 100,000 additional pages of printed materials annually and would overwhelm users. Sorenson proposes instead that it provide detailed information on its Web site and simply provide a link to that information in any promotional materials. Second, Sorenson asks the Commission to clarify that iTRS providers may satisfy the toll free service provider contact information requirement by linking to the Commission's Web site. Finally, Sorenson asks the Commission to limit the customer notification requirements to the one-year transition period. We clarify theiTRS Toll Free Orderin response to Sorenson's first and second requests, and we deny Sorenson's third request.

16. We find that a streamlined approach to the customer notification requirements is consistent both with the purposes of theiTRS Toll Free Orderand with the Commission's general preference for minimizing the burdens of disclosure requirements where possible. We therefore clarify that an iTRS provider may comply with § 64.611(g)(1)(v) and (vi) of the Commission's rules by including on its Web site a clear description of how a user may acquire a toll free number or transfer control of a toll free number from a VRS or IP Relay provider to theuser and the process by which a user may request that the toll free number be linked to his or her ten-digit telephone number in the TRS Numbering Directory. In its promotional materials, the provider may simply provide a link to this information on the provider's Web site. This approach will ensure that deaf and hard-of-hearing users who want to acquire or retain a toll free number can easily find the information they need to do so, while at the same time alleviating Sorenson's concern about the burden on providers.

17. We also clarify theiTRS Toll Free Orderwith respect to toll free service provider contact information. An iTRS provider may satisfy the requirement that it provide contact information by linking to the list of toll free service providers maintained on the 800 Service Management System (SMS/800) Web site. The Commission's Consumer and Governmental Affairs Bureau has produced an American Sign Language video explaining theiTRS Toll Free Order,and the accompanying text directs iTRS users to the SMS/800 Web site's list of toll free service providers, which provides the most up-to-date information. Given that the Commission itself directs deaf and hard-of-hearing consumers to the SMS/800 Web site for toll free service provider information, we find that it is reasonable to allow iTRS providers to do the same.

18. Finally, we deny Sorenson's request to establish a one-year end date for the customer notification requirements. At the end of the one-year transition period established in theOrder,iTRS users will still be able to subscribe to toll free numbers and have them entered into the TRS Numbering Directory. Moreover, with the modified requirements set forth herein, we have significantly reduced the burden of providing such notice.

19. This Order on Reconsideration does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,see44 U.S.C. 3506(c)(4).

20. The rules previously adopted in theiTRS Toll Free Orderwere submitted to Congress and the Government Accountability Office pursuant to the Congressional Review Act and remain unchanged by this Order on Reconsideration.

21. Accordingly,it is ordered,pursuant to the authority contained in sections 1, 4(i), 225, 251(e), 255, and 405 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 225, 251(e), 255, 405, and §§ 1.1 and 1.429 of the Commission's rules, 47 CFR 1.1, 1.429, that this Order on Reconsideration ISadopted, effective thirty (30) days after publication of the text or summary thereof in theFederal Register.

22.It is further ordered,pursuant to the authority contained in section 405 of the Communications Act of 1934, as amended, 47 U.S.C. 405, and § 1.429 of the Commission's rules, 47 CFR 1.429, that the Petition for Reconsideration and Clarification filed by Sorenson Communications, Inc. on October 27, 2011is grantedto the extent described herein and is otherwisedenied.

The Atlantic commercial shark fisheries are managed under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). The 2006 Consolidated Highly Migratory Species (HMS) Fishery Management Plan (FMP) and its amendments under the Magnuson-Stevens Act are implemented by regulations at 50 CFR part 635.

On October 10, 2012, we published a rule (77 FR 61562) proposing the 2013 opening dates for the Atlantic commercial shark fisheries, and quotas based on shark landings information as of August 22, 2012. The proposed rule also considered using adaptive management measures such as flexible opening dates for the fishing seasons (50 CFR 635.27(b)(1)(i)) and inseason adjustments to shark trip limits (50 CFR 635.24(a)(8)) to provide flexibility in managing the furtherance of equitable fishing opportunities, to the extent practicable, for commercial shark fishermen in all regions and areas. This rule is the first time NMFS anticipates using the inseason adjustments. The October 2012 proposed rule contains details regarding the proposal and how the quotas were calculated that are not repeated here.

The comment period on the proposed rule ended on October 28, 2012. During that time, we received 12 written and oral comments on the proposed rule. Those comments, along with the Agency's responses, are summarized below. As detailed more fully in the Response to Comments section, the fishing seasons for all the shark species/complexes will open on January 1, 2013, as proposed in the October 10, 2012 proposed rule. Also, some of the quotas have changed since the proposed rule based on updated landings information received as of November 26, 2012.

This final rule serves as notification of the 2013 opening dates of the Atlantic commercial shark fisheries and 2013 quotas, based on shark landings updates as of November 26, 2012, pursuant to 50 CFR 635.27(b)(1)(i) through (b)(1)(vi). This action does not change the annual base commercial quotas established under Amendments 2 and 3 to the 2006 Consolidated HMS FMP for sandbar sharks, non-sandbar large coastal sharks, blue sharks, porbeagle sharks, and pelagic sharks (other than porbeagle and blue sharks), non-blacknose small coastal sharks, or blacknose sharks. Any such changes would be performed through a separate action. Rather, this action adjusts the annual base commercial quotas based on over- and/or underharvests that occurred in 2011 and 2012, consistent with existing regulations.

We received comments from 12 fishermen, dealers, and other interested parties on the proposed rule. All written comments can be found athttp://www.regulations.gov/and by searching for RIN 0648-XC106.

Comment 1:Commenters noted that non-sandbar large coastal shark meat is easier to sell in the Gulf of Mexico during the religious period of Lent (February 13 to March 30, 2013) and preferred an opening date of February 6, 2013.

Response:In the proposed rule, we considered a season opening date of January 1, 2013, to further equitable fishing opportunities, to the extent practicable, for commercial shark fishermen in all parts of the Gulf of Mexico region. This opening date is consistent with all the criteria listed in § 635.27(b)(1)(ii), but particularly with the requirement that we consider the length of the season for the different species/complexes in the previous years and whether fishermen were able to participate in the fishery in those years (§ 635.27(b)(1)(ii)(C)). Taking into consideration these criteria, we have determined that keeping the proposed opening date of January 1, 2013, for the non-sandbar large coastal shark fishery in the Gulf of Mexico region promotes equitable fishing opportunities throughout this region. Such an opening date would not prevent fishermen and dealers from fishing for and selling sharks during the religious period of Lent unless the quota was fully harvested by that time and the fishery closed.

As an example of how we considered the criteria, we note that the State of Louisiana closes its state waters from April 1 through June 30 for their shark pupping season. Therefore, if we opened the shark fishing season in February, Louisiana fishermen might not have the same opportunity as fishermen elsewhere in the Gulf of Mexico to harvest the available quota because state waters would close shortly after the season opened. This type of situation occurred in both 2011 and 2012, when fishermen from the State of Louisiana had only about a month to fish before the state closed their state waters to shark fishing. As such, we are not changing the proposed opening date of the non-sandbar large coastal shark fishery in order to ensure, to the extent practicable, that fishermen throughout the Gulf of Mexico have equitable fishing opportunities.

Comment 2:We received opposing comments regarding the proposed opening date for the Atlantic non-sandbar large coastal shark fishery. Fishermen from the southern portion of the Atlantic region supported the proposed opening date of January 1, as they feel that the opening date will provide them an opportunity to participate in a winter fishery. Fishermen from the northern portion of the Atlantic region did not want a January 1 opening date since they are concerned that they will not have an opportunity to harvest the quota.

Response:In recent years, in recognition that fishermen in the southern portion of the region could harvest the entire quota before the sharks have migrated north where they could be harvested by fishermen in the northern region, we have opened the non-sandbar large coastal shark fishing season in July. Such an opening date allows fishermen in both areas of the region an opportunity to fully harvest the quota, and was successful in providing fishing opportunities.

However, in 2013, we plan to open the non-sandbar large coastal shark fishery in the Atlantic region on January 1, 2013. As described in the proposed rule for that action, we plan to implement the adaptive management measures from the 2011 shark season rule (75 FR 76302; December 8, 2010) to adjust via inseason actions the retention limit for non-sandbar large coastal sharks. Specifically, if the quota is being harvested quickly and we calculate that the northern fishermen have not yet had an opportunity to fish for non-sandbar large coastal shark because the sharkshave not migrated, we can reduce the trip limits to slow fishing (e.g., change the trip limit from 36 sharks to 15 sharks or even 0 sharks) and then increase them again when we estimate that the sharks have migrated north. This process should ensure equitable fishing opportunities for fishermen along the Atlantic coast while accommodating fishermen's requests from both the southern and northern portions of the Atlantic region. We had not used these measures previously because of concern about our ability to monitor the quota on a real-time basis. However, with the implementation of the HMS electronic reporting system (77 FR 47303; August 8, 2012) on January 1, 2013, we should be able to monitor the quota on a real-time basis and respond quickly as needed. This ability, along with the inseason trip limit adjustment, should allow us the additional flexibility to further opportunities for all fishermen in all regions, to the extent practicable, while also ensuring that quotas are not exceeded.

Comment 3:Many commenters agreed with the effective “increase” in the non-sandbar large coastal shark quotas and retention limits in 2013 and asked for the reasoning behind this increase.

Response:In Amendment 2 to the 2006 Consolidated HMS FMP, we established a 5-year quota reduction to account for overharvest of the non-sandbar large coastal shark and sandbar shark fisheries that occurred in 2007. This 5-year quota reduction ends on December 31, 2012. Therefore, quotas and retention limits for large coastal sharks revert back to base levels in 2013, consistent with Amendment 2 to the 2006 Consolidated HMS FMP.

Comment 4:We received a request to investigate the geographical distribution of non-sandbar large coastal shark landings in the Atlantic throughout the season.

Response:This issue is beyond the scope of this rulemaking, which adjusts the quotas and establishes opening dates. We have reviewed this type of information in past rules, including in Amendment 1 to the 2006 Consolidated HMS FMP on Essential Fish Habitat (EFH) (74 FR 28018; June 12, 2009), Amendment 2 to the 2006 Consolidated HMS FMP on shark management (73 FR 35778, June 24, 2008; corrected at 73 FR 40658, July 15, 2008), and the 2011 shark season rule (75 FR 76302; December 8, 2010). In Amendment 1 to the 2006 Consolidated HMS FMP on EFH, we reviewed the geographical range of all HMS and analyzed the fishing impacts on the EFH for these species. We plan to review EFH in the future and such review necessarily would include the species' geographical range and other relevant analyses, such as species distribution through time. Thus, while re-investigating the geographical distribution for the large coastal shark fishery is beyond the scope of this rulemaking, we may review the issue in future rulemakings.

Comment 5:NMFS should consider increasing the quotas of more dangerous shark species like tiger sharks.

Response:We do not manage sharks or establish shark quotas based on how dangerous a species may be. Rather, we manage sharks based on the best available science for a particular species and legal requirements, which include maintaining or conserving the stock and its yield. Tiger sharks are included as part of the non-sandbar large coastal shark complex for various reasons, including the lack of a stock specific assessment, the fact that tiger sharks are often caught on the same type of gear as other non-sandbar large coastal sharks, and because tiger sharks are not a major species in the commercial fishery. The quota for non-sandbar large coastal sharks was established in Amendment 2 to the 2006 Consolidated HMS FMP based on the best available science and legal requirements. We would consider establishing a species-specific commercial quota for tiger sharks in a future rulemaking if the scientific advice indicated such action was supportable and warranted.

Comment 6:We received several comments regarding the proposal not to open the porbeagle shark quota in 2013. Several commenters supported NMFS' decision not to allow porbeagle shark landings because of the small amount of quota that we thought would be available at the proposed rulemaking stage. Other commenters indicated that not allowing porbeagle shark landings would result in a lot of dead discards, since porbeagle sharks are caught incidentally in other fisheries in the north Atlantic area.

Response:We proposed not to open the porbeagle shark quota in 2013 due to the small adjusted quota (0.5 mt dw) available once overharvests from 2011 and 2012 were accounted for, and due to difficulties in accurately monitoring such a small quota. Since the publication of the proposed rule, updated landings data indicate additional porbeagle shark landings, which resulted in a combined overharvest from 2011 and 2012 that exceeds the 2013 base commercial quota. Specifically, in 2011, updated landings data indicate an additional 0.8 mt dw (1,781 lb dw) of landings. In the proposed rule, we accounted for 0.1 mt dw (227 lb dw) of 2011 porbeagle shark landings that were reported after the 2012 shark season rule was published. Additionally, as of November 26, 2012, a total of 1.9 mt dw was reported landed in 2012, which is 1.2 mt dw (2,614 lb dw) higher than the 2012 porbeagle shark quota. In total, the actual combined overharvest from 2011 and 2012 is 2.1 mt dw (4,622 lb dw). This combined overharvest exceeds the base 2013 commercial landings quota of 1.7 mt dw (3,748 lb dw) by 0.4 mt dw (874 lb dw). Therefore, based on preliminary estimates and consistent with the current regulations at § 635.27(b)(1)(i)(A), the overharvested amount must be deducted from future years' fishing quotas. After the appropriate deductions, no quota is available for commercial porbeagle shark landings in 2013, and we are planning to reduce the 2014 fishing quota to account for the remaining overharvest.

We understand that not allowing porbeagle shark landings means that any porbeagle sharks that are caught incidentally during other fishing must be discarded, either alive or dead. However, while we account for dead discards in establishing the total allowable catch for the species, dead discards are not part of the commercial porbeagle shark quota. In Amendment 2 to the 2006 Consolidated HMS FMP, we established a rebuilding plan for porbeagle sharks that set the total allowable catch at 11.3 mt dw. This total allowable catch caps fishing mortality, which encompasses commercial landings, recreational landings, and commercial dead discards. The commercial porbeagle quota was established at 1.7 mt dw, while the recreational catch, including landings in tournaments, was 0.1 mt dw and commercial discards were 9.5 mt dw. Any dead discards that occur will be accounted for and used in future stock assessments and any adjustments that result from those assessments.

Comment 7:NMFS needs to address the large number of porbeagle sharks that are caught in the recreational fishery and add porbeagle sharks to the prohibited species list.

Response:This comment is beyond the scope of this rulemaking. This rulemaking focuses on adjusting the commercial shark quotas based on over- and underharvests from previous years and establishing opening dates for the 2013 commercial shark season. Restricting the catches of porbeagle sharks in the recreational fishery and any consideration of adding them to the prohibited species list could beaddressed in a future rulemaking if deemed appropriate at that time.

Comment 8:NMFS should stop all shark fishing.

Response:This comment is outside the scope of this rulemaking. The purpose of this rulemaking is to adjust quotas based on over- and underharvests from the previous year and opening dates for the 2013 shark season. Management of the Atlantic shark fisheries is based on the best available science to maintain or rebuild overfished shark stocks. The final rule does not reanalyze the overall management measures for sharks, which were analyzed in Amendments 2 and Amendment 3 to the 2006 Consolidated HMS FMP, and are being reviewed again for some shark species in response to new stock assessments through draft Amendment 5 to the 2006 Consolidated HMS FMP.

Comment 9:A commenter was happy that NMFS did not change the regulations for the small coastal shark fisheries, including the non-blacknose and blacknose shark fisheries, in 2013.

Response:As noted in Response to Comment 8, the 2013 shark season rule establishes commercial quotas based on over- and underharvest in 2012, and sets the opening dates for the non-blacknose small coastal shark and blacknose shark fishing seasons. Since the non-blacknose small coastal shark fishery is not overfished with no overfishing occurring, any underharvests for the non-blacknose small coastal sharks therefore could be applied to the 2013 quotas, pursuant to 50 CFR 635.27(b)(i)(B). However, blacknose sharks are overfished with overfishing occurring, so the 2013 final quotas are the base annual quotas for blacknose sharks. Since both fisheries remained open for the entire year, we decided to open the fishery again on January 1. Any other changes to the fisheries beyond the opening dates and adjusting the quotas are outside the scope of this rulemaking.

Comment 10:We received a comment on how NMFS determines if a species is “underharvested.” The commenter noted that annual landings less than the available quotas could indicate that stock populations have declined over time due to overfishing.

Response:A species is underharvested if the annual quota was not fully landed. In 2011, the Gulf of Mexico and Atlantic non-sandbar large coastal sharks, shark research, non-blacknose small coastal sharks, blacknose sharks, blue sharks, and pelagic sharks (other than porbeagle and blue sharks) quotas were all underharvested, since the landings did not reach the annual quotas. Even though many of the fishing quotas were underharvested, this does not necessarily indicate a decline in the stock populations. There are many factors that can impact the amount of shark fishing every year. Factors like weather, shark migratory patterns, and market prices would affect fishing effort and catch rates of shark fishermen. In addition, annual fishing quotas were established to end overfishing and to ensure that the stock can withstand the current fishing effort and continue to rebuild in the future. We assess stocks on a regular basis to ensure that stocks are rebuilding, if appropriate, and their status is being maintained or improved.

Comment 11:We received a question on how NMFS accounts for illegal landings or information withheld about commercial catches, and how they are factored into the final quotas.

Response:We use dealer landings and fishermen logbook data to establish the annual landings. To the extent that illegal landings are included in this data, they are considered in establishing annual landings and used for quota monitoring purposes. Some illegal landings are not reported in logbooks or dealer reports (e.g., sharks harvested by Mexican lanchas in the Gulf of Mexico) and are not used for quota monitoring purposes. However, when NMFS has estimates of illegal landings, NMFS uses that data to establish annual quotas, as appropriate, and in stock assessments, which in turn helps determine the annual baseline quotas. For the 2013 shark season rule, we used reported landings data from October 31 to December 31, 2011, and 2012 fishing year landings data as of November 26, 2012, to determine if any shark species or complex was overharvested. Any reported landings beyond November 26, 2012, will be accounted for the 2014 annual quotas. Management likely would not have access to landings information beyond November 26, 2012, until January 1, 2013. Therefore, we used the most recent available information to allow us to properly analyze the fishery and open the fishery in January.

Comment 12:We received a comment asking how the Agency defines the term “equitable fishing opportunities.”

Response:We define equitable fishing opportunities as fair distribution of the annual quota to fishermen located throughout a region across states consistent with legal requirements including National Standard 4 of the Magnuson-Stevens Act. The adaptive management measures allowing inseason adjustments to trip limits, in combination with the implementation of the HMS electronic dealer reporting system, which allows for more real-time reporting by dealers, should provide us a greater ability to ensure equitable fishing opportunities for fishermen located in the Atlantic or in the Gulf of Mexico regions. Inseason adjustment of the trip limit will provide us additional control over how slowly or quickly the quota is being taken and provide quota for fishermen throughout a region.

Comment 13:NMFS should give the increased sandbar shark research quota to the normal commercial fishery since the research fishery has harvested less than half of the 2012 sandbar shark quota.

Response:This comment is beyond the scope of this rulemaking. In part due to the small amount of sandbar shark quota available, in Amendment 2 to the 2006 Consolidated HMS FMP, we established a shark research fishery to maintain time series data for stock assessments and to meet our research objectives. The shark research fishery also allows selected commercial fishermen the opportunity to land and sell sandbar sharks. Only the commercial shark fishermen selected to participate in the shark research fishery are authorized to land sandbar sharks subject to the sandbar quota available each year. Changes to this part of the fishery are outside the scope of this rulemaking. This issue could be analyzed in future rulemakings if deemed appropriate.

We made several changes to the proposed rule as described below.

1. We changed the final non-blacknose small coastal and porbeagle shark quotas based on landings updates through November 26, 2012. In the proposed rule, which was based on data available through August 22, 2012, the 2013 adjusted annual quota for the non-blacknose small coastal shark was 332.4 mt dw (732,808 lb dw). Based on updated landings data through November 26, 2012, the non-blacknose small coastal shark fishery was underharvested by 107.6 mt dw. Therefore, the 2013 adjusted annual quota for non-blacknose small coastal shark is 329.2 mt dw (725,645 lb dw) (221.6 mt dw annual base quota + 107.6 mt dw 2012 underharvest = 329.2 mt dw 2013 adjusted annual quota). Landings information beyond November 26, 2012, will not become available to us until January 1, 2013. This final rule used the most recent available information to allow us to properly analyze the fishery and open the fishery in January.

Since overharvests of the porbeagle quota occurred between October 31, 2011, and December 31, 2011, and during the 2012 fishing year, the available 2013 annual quota for porbeagle sharks at the proposed rule stage was thought to be 0.5 mt dw based on the August 22, 2012, shark landings data. Since the proposed rule published, updated landings data for 2011 indicate an additional 0.8 mt dw (1,781 lb dw) landings in excess of the 0.1 mt dw (227 lb dw) of porbeagle sharks that were accounted for as overharvested in the proposed rule. Additionally, as of November 26, 2012, a total of 1.9 mt dw was reported landed in 2012, which is 1.2 mt dw (2,614 lb dw) higher than the 2012 porbeagle shark quota. In total, the combined overharvest from 2011 and 2012 is 2.1 mt dw (4,622 lb dw). As such, the 2013 adjusted annual commercial porbeagle quota was exceeded by 0.4 mt dw (874 lb dw) (1.7 mt dw annual base quota − 0.1 mt dw 2011 additional overharvest − 0.8 mt dw 2011 updated landings − 1.2 mt dw 2012 overharvest = −0.4 mt dw 2013 adjusted annual quota). Thus, we will not allow commercial porbeagle shark landings in 2013, and are planning to reduce the 2014 fishing quota to account for the rest of the overharvest. Details of the resulting changes to the quota can be found in Table 1 and below.

2. We changed the reason for not opening the porbeagle shark quota in 2013. As noted above, in the proposed rule, we stated we would not allow porbeagle shark landings due to the small quota and difficulties in accurately monitoring such a small quota. However, as we state above, since the combined overharvest from 2011 and 2012 is 2.1 mt dw (4,622 lb dw), we are deducting the overharvested amount from the 2013 fishing quota, will not allow porbeagle shark landings in 2013, and will reduce the 2014 annual quota to account for this overharvest.

This final rule adjusts the commercial quotas due to over- and/or underharvests in 2011 and 2012 using information up to November 26, 2012. The 2013 annual quotas by species and species group are summarized in Table 1. All dealer reports that are received by us after November 26, 2012, will be used to adjust the 2014 quotas, if necessary. A description of the quota calculations is provided in the proposed rule and is not repeated here. Any changes are described above in the “Changes from the Proposed Rule” section.