The regulations in “Subpart—Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-54, referred to below as the regulations) prohibit or restrict the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of plant pests that are new to or not widely distributed within the United States.

The regulations currently allow for the importation of both Ya pears ( Pyrus bretschneideri ) and fragrant pears ( Pyrus sp. nr. communis ) from China. The conditions for importation of Ya pears are found in § 319.56-29 of the regulations; those for fragrant pears are found in § 319.56-39 of the regulations.

The national plant protection organization (NPPO) of China has requested that the Animal and Plant Health Inspection Service (APHIS) amend the regulations to also allow Chinese sand pears ( Pyrus pyrifolia ) from China to be imported into the United States.

As part of our evaluation of China's request, we have prepared a pest risk assessment (PRA), titled “Importation of Fresh Fruit of Chinese Sand Pear, Pyrus pyrifolia, from China, including the Special Administrative Regions of Hong Kong and Macau, into the Entire United States, Including all Territories” (July 2009). The PRA evaluates the risks associated with the importation of Chinese sand pears into the United States from China. Copies of the PRA may be obtained by contacting the individual listed under FOR FURTHER INFORMATION CONTACT or viewed on the Regulations.gov Web site (see ADDRESSES above for instructions for accessing Regulations.gov).

The PRA identifies 16 pests of quarantine significance present in China that could be introduced into the United States through the importation of Chinese sand pears:

• Acrobasis pyrivorella, pear fruit moth.

• Alternaria gaisen Nagano, black spot of Japanese pear.

• Amphitetranychus viennensis (Zacher), Hawthorn spider mite.

• Aphanostigma iaksuiense (Kishida), an aphid.

• Bactrocera dorsalis, Oriental fruit fly.

• Caleptrimerus neimongolensis Kuang and Geng, a mite.

• Carposina sasakii Matsumora, peach fruit moth.

• Ceroplastes japonicus Green, Japanese wax scale.

• Ceroplastes rubens Maskell, red wax scale.

• Conogothes punctiferalis (Guenée), yellow peach moth.

• Grapholita inopinata, Manchurian fruit moth.

• Guignardia pyricola (Nose) W. Yamamoto, a phytopathogenic fungus.

• Monilinia fructigena Honey in Whetzel, brown fruit rot.

• Phenacoccus pergandei Cockerell, a mealybug.

• Planococcus kraunhiae (Kuwana), a mealybug.

• Venturia nashicola Tanaka & Yamamoto, pear scab fungus.

The PRA states that measures beyond standard port-of-entry inspection are required to mitigate the risks posed by these plant pests, and provides a number of potential options for such measures. After consideration of these options, we have prepared a risk management document (RMD) to recommend specific measures to mitigate these risks. Copies of the RMD may be obtained from the person listed under FOR FURTHER INFORMATION CONTACT or viewed on the Regulations.gov Web site.

Based on the recommendations of the RMD, we are proposing to allow the importation of Chinese sand pears from China into the United States only if they are produced in accordance with a systems approach; we are proposing to add the systems approach to the regulations in a new § 319.56-55 governing the importation of Chinese sand pears from China.

Most of the pests identified by the PRA as being likely to follow the pathway of Chinese sand pears from China were previously identified as likely to follow the pathway of Ya pears or fragrant pears from China. Moreover, since we authorized the importation of Ya pears and fragrant pears from China into the United States, none of the quarantine pests identified for those commodities has been detected during inspections of the pears at ports of first arrival in the United States. The absence of detections over a prolonged period of time—more than 5 years for both Ya pears and fragrant pears—demonstrates the efficacy of the mitigation measures in place for the importation of Ya pears and fragrant pears from China. Hence, many of the mitigation measures in the systems approach would be modeled on existing measures for the importation of Ya pears or fragrant pears from China.

There would, however, be one significant difference. Whereas we limit the origin of Ya pears and fragrant pears grown for export to the United States to areas within China in which Oriental fruit fly is not known to exist and could not survive (areas north of the 33rd parallel), we would authorize the importation into the United States of Chinese sand pears grown in any area of China, including areas south of the 33rd parallel. 1 Pears grown in areas south of the 33rd parallel would, however, be subject to additional mitigation measures necessary to address the risk posed by the Oriental fruit fly.

Paragraph (a) of § 319.56-55 would set out general requirements for the NPPO of China and for growers and packers producing sand pears for export to the United States.

Paragraph (a)(1) of § 319.56-55 would require the NPPO of China to provide an operational workplan to APHIS that details the activities that the NPPO will, subject to APHIS' approval of the workplan, carry out to meet the requirements of proposed § 319.56-55. As described in a notice we published on May 10, 2006, in the Federal Register (71 FR 27221-27224, Docket No. APHIS-2005-0085), an operational workplan is an agreement between APHIS' Plant Protection and Quarantine (PPQ) program, officials of the NPPO of a foreign government, and, when necessary, foreign commercial entities that specifies in detail the phytosanitary measures that will comply with our regulations governing the import or export of a specific commodity. Operational workplans establish detailed procedures and guidance for the day-to-day operations of specific import/export programs. Workplans also establish how specific phytosanitary issues are dealt with in the exporting country and make clear who is responsible for dealing with those issues. The implementation of a systems approach typically requires an operational workplan to be developed.

Paragraph (a)(2) would require the pears to be grown in places of production that are registered with the NPPO of China.

Paragraph (a)(3) would require the pears to be packed for export to the United States in pest-exclusionary packinghouses that are registered with the NPPO of China.

Paragraph (a)(4) would state that sand pears from China may be imported in commercial consignments only. Produce grown commercially is less likely to be infested with plant pests than noncommercial consignments. Noncommercial consignments are more prone to infestation because the commodity is often ripe to overripe and is often grown with little to no pest control. Commercial consignments, as defined within the regulations, are consignments that an inspector identifies as having been imported for sale and distribution. Such identification is based on a variety of indicators, including, but not limited to: Quantity of produce, type of packaging, identification of grower or packinghouse on the packaging, and documents consigning the fruits or vegetables to a wholesaler or retailer. We currently require both Ya pears and fragrant pears from China to be imported in commercial consignments as a mitigation measure against the quarantine pests associated with these species of pear.

Our systems approach would require certain measures to take place at the registered places of production. Proposed paragraph (b) of § 319.56-55 would contain these measures.

Paragraph (b)(1) would require all propagative material entering a registered place of production to be tested and certified by the NPPO of China as being free of quarantine pests. Propagative material that is not tested and certified presents a risk of introducing quarantine pests into a place of production; since several of the quarantine pathogens have latency periods, this is true even if the material appears asymptomatic.

Paragraph (b)(2) would require the place of production to carry out any phytosanitary measures specified for the place of production under the operational workplan. Depending on the location, size, and plant pest history of the orchard, these measures may include surveying protocols, safeguarding of trees, or application of pesticides and fungicides.

Paragraph (b)(3) would state that, when any sand pears destined for export to the United States are still on the tree and are no more than 2.5 centimeters in diameter, double-layered paper bags must be placed wholly over the pears. The bags would have to remain intact and on the pears until the pears arrive at the packinghouse. This bagging protocol, which is modeled on a similar requirement for Ya pears from China, helps protect the pears against the quarantine moths and fungi.

Paragraph (b)(4) would require the NPPO of China to visit and inspect registered places of production prior to harvest for signs of infestations and would allow APHIS to monitor the inspections. The NPPO would also have to provide records of pest detections and pest detection practices to APHIS, and APHIS would have to approve these practices. This provision is modeled on an existing provision for the importation of fragrant pears from China, and serves a dual purpose: It not only provides for the NPPO of China to inspect the place of production for quarantine pests in a manner that APHIS believes to be sufficiently rigorous, but also affords the NPPO the opportunity to determine whether the orchard has continually maintained the phytosanitary measures specified for it under the operational workplan.

Paragraph (b)(5) would state that, if any of the listed quarantine pests is detected at a registered place of production, APHIS could reject the consignment or prohibit the importation into the United States of sand pears from the place of production for the remainder of the season. The exportation to the United States of sand pears from the place of production could resume in the next growing season if an investigation is conducted and APHIS and the NPPO conclude that appropriate remedial action has been taken.

Paragraph (c) of § 319.56-55 would set forth requirements for mitigation measures that would have to take place at registered packinghouses.

Paragraph (c)(1) would require that, during the time registered packinghouses are in use for packing sand pears for export to the United States, the packinghouses may only accept sand pears that are from registered places of production and that are produced in accordance with the requirements of proposed § 319.56-55. Pears from other places of production may be produced under conditions that are less stringent than those of this proposed rule, and may therefore be a pathway for the introduction of quarantine pests into the packinghouses.

Paragraph (c)(2) would require packinghouses to have a tracking system in place to readily identify all sand pears destined for export to the United States that enter the packinghouse back to their place of production. In the event that quarantine pests are discovered in any consignment, the packinghouse would have to use the tracking system to determine the place of production of the pears, and supply the NPPO of China or officials authorized by the NPPO with this information. The NPPO would then inspect the place of production in order to determine the scope of the outbreak and the remedial actions necessary to address it.

Paragraph (c)(3) would require the NPPO of China or officials authorized by the NPPO to inspect the pears at the packinghouses for signs of pest infestation and would allow APHIS to monitor the inspections. If any of the listed quarantine pests is detected in a consignment at the packinghouse, APHIS may reject the consignment.

Paragraph (c)(4) would state that, following the inspection, the packinghouse must follow a handling procedure for the pears that is mutually agreed upon by APHIS and the NPPO of China. Handling procedures could include such measures as culling damaged pears, removing leaves off of the pears, wiping the pears with a clean cloth, air blasting, or grading.

Paragraph (c)(5) would require the sand pears to be packed in cartons that are labeled with the identity of the place of production and the packinghouse. In the event that quarantine pests are discovered in a consignment of pears after it is exported to the United States, this labeling will facilitate traceback and help the NPPO and APHIS delimit the scope of the outbreak.

Paragraph (c)(6) would require the cartons to be placed in insect-proof containers, and the containers to be sealed. It would also require the containers to be safeguarded during transport to the United States in a manner that will prevent pest infestation. These requirements preclude introduction of pests while the pears are in transit from the packinghouse to the port of export, and from the port of export to the United States.

Proposed paragraph (d) of § 319.56-55 would set forth shipping requirements for sand pears from China. It would require sealed containers of sand pears destined for export to the United States to be held in a cold storage facility while awaiting export. This would help to prevent pest infestation of packed pears, as certain of the quarantine pests for Chinese sand pears from China are averse to cold conditions.

Paragraph (e) of § 319.56-55 would require each consignment of sand pears imported from China into the United States to be accompanied by a phytosanitary certificate issued by the NPPO of China with an additional declaration stating that the requirements of § 319.56-55 have been met and the consignment has been inspected and found free of quarantine pests.

The mitigation measures contained in proposed paragraphs (a) through (e) of § 319.56-55 would apply to all Chinese sand pears imported into the United States from China. However, since the Oriental fruit fly is known to exist, in varying population densities, in areas of China south of the 33rd parallel, Chinese sand pears from such areas would be subject to additional mitigation measures designed to prevent infested pears from being exported to the United States. Proposed paragraph (f) of § 319.56-55 would contain these additional mitigations.

Paragraph (f)(1) would require the place of production of the pears and the packinghouse in which they are packed have a trapping system in place for the Oriental fruit fly. At a minimum, the trapping system would have to meet the following requirements:

• All traps would have to use an APHIS-approved lure.

• At least one trap per square kilometer would have to be placed in the place of production or packinghouse.

• Traps would have to be placed in the area with a 2-kilometer radius that surrounds the place of production or packinghouse at a rate of one trap per square kilometer.

• Traps would have to be serviced every 2 weeks.

Paragraph (f)(2) would require the place of production or the packinghouse to retain data regarding the number and location of the traps, as well as any pests other than Oriental fruit fly that have been caught, and make this information available to APHIS upon request.

Paragraph (f)(3) would require the place of production or the packinghouse to notify the NPPO of China, and the NPPO of China to notify APHIS, regarding the detection of a single Oriental fruit fly in a place of production, packinghouse, or surrounding area within 48 hours of the detection. If a single Oriental fruit fly is detected in a registered place of production, APHIS would prohibit the importation into the United States of sand pears from the place of production until any mitigation measures determined by APHIS to be necessary to prevent future infestations are taken. Likewise, if a single Oriental fruit fly is detected in a registered packinghouse, the packinghouse could not be used to pack sand pears for export to the United States until any mitigation measures determined by APHIS to be necessary to prevent future infestations are taken. Mitigation measures that we may require a place of production or packinghouse to take include increasing trap density or treating the entire place of production or packinghouse with an APHIS-approved insecticidal spray.

Paragraph (f)(4) would require the pears to be treated in accordance with 7 CFR part 305. Within part 305, § 305.2 provides that approved treatment schedules are set out in the PPQ Treatment Manual, found online at http://www.aphis.usda.gov/import_export/plants/manuals/ports/ downloads/treatment.pdf. (The manual specifies that cold treatment schedule T107 is effective in neutralizing Oriental fruit fly on sand pears.)

This proposed rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

In accordance with 5 U.S.C. 603, we have performed an initial regulatory flexibility analysis regarding the economic effects of this proposed rule on small entities. The economic analysis examines pear production in the United States and the amount of Chinese sand pears likely to be imported from China into the United States if this proposed rule is finalized. It identifies U.S. pear producers as the small entities most likely to be impacted by the provisions of the proposed rule, and requests public comment regarding the cost of the rule to such entities.

Copies of the full analysis are available by contacting the person listed under FOR FURTHER INFORMATION CONTACT or on the Regulations.gov Web site (see ADDRESSES above for instructions for accessing Regulations.gov).

This proposed rule would allow Chinese sand pears to be imported into the United States from China. If this proposed rule is adopted, State and local laws and regulations regarding sand pears imported under this rule would be preempted while the fruit is in foreign commerce. Fresh sand pears are generally imported for immediate distribution and sale to the consuming public and would remain in foreign commerce until sold to the ultimate consumer. The question of when foreign commerce ceases in other cases must be addressed on a case-by-case basis. If this proposed rule is adopted, no retroactive effect will be given to this rule, and this rule will not require administrative proceedings before parties may file suit in court challenging this rule.

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), the information collection or recordkeeping requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB). Please send written comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503. Please state that your comments refer to Docket No. APHIS-2011-0007. Please send a copy of your comments to: (1) Docket No. APHIS-2011-0007, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue SW., Washington, DC 20250. A comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication of this proposed rule.

We are proposing to amend the fruits and vegetables regulations to allow the importation of sand pears from China into the United States. As a condition of entry, sand pears from China would have to be produced in accordance with a systems approach that would include requirements for registration and monitoring of places of production and packinghouses; sourcing of all propagative material that enters the place of production; orchard sanitation; inspection for quarantine pests at set intervals by the national plant protection organization of China; bagging of fruit; safeguarding; labeling; and importation of the sand pears in commercial consignments. Implementation of this proposed rule would require persons to fill out various forms and documents. These include: Phytosanitary certificates, workplans, registration and inspection forms, and labels.

We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:

(1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses).

Estimate of burden: Public reporting burden for this collection of information is estimated to average 0.62595 hours per response.

Respondents: The NPPO of China, importers of Chinese sand pears.

Estimated annual number of respondents: 28.

Estimated annual number of responses per respondent: 4.67857.

Estimated annual number of responses: 131.

Estimated total annual burden on respondents: 82 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

Copies of this information collection can be obtained from Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.

The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.

Accordingly, we are proposing to amend 7 CFR part 319 as follows:

On December 6, 2011, (Agencywide Documents Access and Management System (ADAMS) Accession No. ML113400015) the NRC published a notice of public meeting (Category 2 Public Meeting to Discuss the Regulatory Basis for Streamlining the Non-power Reactor License Renewal) to be held December 19, 2011. Options being considered in the regulatory basis were provided as an attachment to the meeting notice.

In Staff Requirements Memorandum (SRM) SRM-SECY-08-0161 (ADAMS Accession No. ML090850159) the Commission directed the staff to develop and submit for Commission review a long-term plan for an enhanced Research and Test reactor (RTR) license renewal process. The Commission advised that this long term plan should consider elements of the generic analysis approach, generic siting analysis, and the extended license term described in SECY-08-0161 (ADAMS Accession No. ML082550140) to establish a stable and predictable regulatory regime for RTRs.

Based on the Commission's direction and the comments received during the public meeting held on September 13, 2011, (ADAMS Accession No. ML112710285), the staff is hosting the December 19, 2011 meeting to discuss the proposed options being considered in development of the regulatory basis for streamlining the non-power license renewal process. The NRC staff will also discuss possible changes to EP requirements for non-power reactors. The NRC notes that the public, licensees, certificate holders, and other stakeholders will have a future opportunity to comment on the regulatory basis document when it is published in the Federal Register .

You can access publicly available documents related to this notice using the methods below.

Please include Docket ID NRC-2011-0087 in the subject line of your comments. Comments submitted in writing or in electronic form will be posted on the NRC Web site and on the Federal rulemaking Web site, http://www.regulations.gov. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed.

The NRC requests that any party soliciting or aggregating comments received from other persons for submission to the NRC inform those persons that the NRC will not edit their comments to remove any identifying or contact information, and therefore, they should not include any information in their comments that they do not want publicly disclosed. You may submit comments by any one of the following methods:

• Federal Rulemaking Web Site: Go to http://www.regulations.gov and search for documents filed under Docket ID NRC-2011-0087. Address questions about NRC dockets to Carol Gallagher, telephone: (301) 492-3668; email: Carol.Gallagher@nrc.gov.

• Mail comments to: Cindy Bladey, Chief, Rules, Announcements, and Directives Branch (RADB), Office of Administration, Mail Stop: TWB-05-B01M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

• Fax comments to: RADB at (301) 492-3446.

You can access publicly available documents related to this notice using the following methods:

• NRC's Public Document Room (PDR): The public may examine and have copied, for a fee, publicly available documents at the NRC's PDR, O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

• NRC's Agencywide Documents Access and Management System (ADAMS): Publicly available documents created or received at the NRC are available online in the NRC Library at http://www.nrc.gov/reading-rm/adams.html. From this page, the public can gain entry into ADAMS, which provides text and image files of the NRC's public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC's PDR reference staff at 1-(800) 397-4209, (301) 415-4737, or by email to pdr.resource@nrc.gov.

• Federal Rulemaking Web Site: Public comments and supporting materials related to this notice can be found at http://www.regulations.gov by searching on Docket ID NRC-2011-0087.

The NRC provides reasonable accommodations to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in this meeting (e.g., sign language), or need this meeting notice or other information from the meeting in another format, please notify the NRC meeting contact, Duane Hardesty at (301) 415-3724 by December 16, 2011, so arrangements can be made.

All expected attendees must register with the NRC meeting contact by close of business on December 16, 2011. All attendees are to use the main One White Flint visitor entrance. The NRC is accessible to the White Flint Metro Station. Visitor parking near the NRC buildings is limited.

Title III of the Energy Policy and Conservation Act (EPCA), as amended (42 U.S.C. 6291 et seq. ), sets forth various provisions designed to improve energy efficiency. Part A of Title III of EPCA (42 U.S.C. 6291-6309) established the Energy Conservation Program for Consumer Products Other Than Automobiles,” which covers consumer products and certain commercial products (referred to as “covered products”). 1 In addition to specifying a list of covered residential and commercial products, EPCA contains provisions that enable the Secretary of Energy to classify additional types of consumer products as covered products.

DOE recently published a Notice of Proposed Determination (76 FR 34914, June 15, 2011) (hereafter referred to as “proposed determination”) that preliminarily determined that STBs and network equipment meet the criteria for covered products because classifying products of such type as covered products is necessary or appropriate to carry out the purposes of EPCA, and the average U.S. household energy use for STBs and network equipment is likely to exceed 100 kilowatt-hours (kWh) per year.

DOE may prescribe test procedures for any product it classifies as a “covered product.” (42 U.S.C. 6293(b)) Further, DOE may consider prescribing energy conservation standards for a type of consumer product it classifies as covered if the product meets certain additional criteria, such as “average per household energy use within the United States” in excess of 150 kWh and “aggregate household energy use” in excess of 4.2 billion kWh, for any prior 12-month period. (42 U.S.C. 6295(l)(1))

DOE is initiating the rulemaking and data collection process for a test procedure and potential establishment of an energy conservation standard for STBs and network equipment with publication of this RFI. This process will analyze the technological, environmental, employment, and regulatory impact of a test procedure and standard on consumers, manufacturers, utilities, and the nation. During this analysis, DOE will determine the feasibility of establishing a standard that achieves the maximum improvement in energy efficiency that is technologically feasible and economically justified. To support this analysis, DOE will develop a test procedure to measure the energy efficiency of STBs and network equipment that reflects consumer use, ensures repeatability of results and is not unduly burdensome to conduct. DOE is asking interested parties for additional information that will assist DOE in performing its analysis and in developing a test procedure and energy conservation standard for STBs and network equipment.

For reference, DOE has published a Market and Technology Assessment on the DOE Set-Top Box and Network Equipment Appliance Standards Web site, located at http://www1.eere.energy.gov/buildings/appliance_standards/residential/set_top_boxes.html , that includes the data currently gathered on STBs.

Note that any comments already provided in response to the proposed determination do not need to be resubmitted. DOE will formally respond to comments already submitted in a final determination for coverage of STBs and network equipment that will be issued at a later stage in the rulemaking process.

DOE will review existing industry test procedures and standards to develop its own test procedure and efficiency standard for STBs and network equipment. Current industry test procedures and standards for STBs include the Environmental Protection Agency's (EPA) ENERGY STAR® Program Requirements for Set-top Boxes Version 3.0, 2 Canadian Standards Association's (CSA) test procedure C380-08, 3 and Consumer Electronics Association's (CEA) industry standards CEA-2013  4 and CEA-2022. 5 Additionally, DOE will evaluate the International Electrotechnical Commission's (IEC) industry standard IEC-62087, 6 which includes STBs in its scope. Notably, the ENERGY STAR program defines its own test method for STBs, but does reference the CSA test procedure for test setup and instrumentation. The CEA standards are similar to CSA's test procedure, but they cover fewer functional features as compared to the ENERGY STAR method. These test procedures and industry standards were used as a basis for identifying the below issues for which DOE is specifically seeking feedback. 7

When necessary, DOE divides covered products into classes by the type of energy used, the capacity of the product, and any other performance-related feature that justifies different standard levels, such as features affecting consumer utility. (42 U.S.C. 6295(q)) As part of this rulemaking proceeding, DOE will evaluate the market for STBs and potentially separate them into product classes based on the criteria outlined above.

The current ENERGY STAR program separates STBs into different base functionalities: Cable, Satellite, Cable Digital Transport Adapter (DTA), Internet Protocol (IP), Terrestrial, and Thin Client/Remote. 8 Each base functionality type has a different energy consumption allowance (i.e., a different efficiency level) for qualification with the ENERGY STAR specification. Differentiating products by functionalities recognizes the fact that different underlying technologies such as Cable and Satellite STBs may require more energy than Thin Clients or Cable DTA STBs. ENERGY STAR also provides for higher energy consumption allowances based on various additional features (e.g. Digital Video Recorder, High Definition Resolution).

As part of DOE's investigation of potential product classes for STBs and network equipment, DOE is considering investigating the definitions of STB base functionality types and the additional features currently employed by the ENERGY STAR program. 9 In particular, DOE is considering defining a separate product class for each combination of functionality type and an additional feature or features. However, in order to make this determination, DOE will have to analyze whether each combination of functionality type and additional features meets DOE's criteria for establishing product classes. Further details concerning the base functionality types and additional features used by the ENERGY STAR program are discussed below.

• Cable: A STB whose primary function is to receive television signals from a broadband, hybrid fiber/coaxial, or community cable distribution system with conditional access and deliver them to a consumer display, thin-client/remote STB, and/or recording device.

• Satellite: A STB whose primary function is to receive television signals from satellites and deliver them to a consumer display, thin-client/remote STB, and/or recording device.

• Cable Digital Transport Adapter (Cable DTA): A minimally-configured STB whose primary function is to receive television signals from a broadband, hybrid fiber/coaxial, or community cable distribution system and deliver them to a consumer display and/or recording device.

• Internet Protocol Television (IPTV): A STB whose primary function is to receive television/video signals encapsulated in Internet Protocol packets and deliver them to a consumer display, thin-client/remote STB, and/or recording device.

• Terrestrial: A STB whose primary function is to receive television signals over the air or via community cable distribution system without conditional access and deliver them to a consumer display, thin-client/remote STB, and/or recording device.

• Thin-client/Remote: A STB that (1) is designed to interface between a multi-room STB and a TV (or other output device), (2) has no ability to directly interface with a Service Provider, and (3) relies solely on a multi-room STB for content. Any STB that meets the definition of a cable, satellite, IP, or terrestrial STB is not a thin-client/remote STB.

• Advanced Video Processing (AVP): The capability to encode, decode, and/or transcode audio/video signals in accordance with standards H.264/MPEG 4 or SMPTE 421M.

• CableCARD: The capability to decrypt premium audio/video content and services and provide other network control functions via a plug-in conditional access module that complies with the ANSI/SCTE 28 2007 HOST-POD Interface Standard. 10

• Digital Video Recorder (DVR): The capability to store video in a digital format to a rewritable disk drive or other non-volatile storage device integrated into a STB. This definition excludes video capture software for personal computers or server-based DVR capabilities.

• DOCSIS: The capability to distribute data and audio/video content over cable television infrastructure in accordance with the CableLabs® Data Over Cable Service Interface Specification.

• High Definition (HD) Resolution: The capability to transmit or display video signals with resolution greater than or equal to 720p.

• Standard Definition (SD) Resolution: The capability to only transmit or display video signals with resolution less than 720p.

• Home Network Interface (HNI): The capability to interface with external devices over a high bandwidth network (e.g., IEEE 802.11 (WiFi), MoCA, HPNA). For purposes of this specification, IEEE 802.3 wired Ethernet is not considered a Home Network Interface.

• Multi-room (MR): The capability to provide independent audio/video content to multiple devices within a single family dwelling. This definition does not include the capability to manage gateway services for multi-subscriber scenarios.

• Multi-stream (MS): The capability to deliver two or more simultaneous audio/video streams to a consumer display, thin-client/remote STB, or recording device. The simultaneous streams may be delivered via a physically separate input or via the primary input. This definition does not include out-of-band tuners.

• Removable Media Player: The capability to decode digitized audio/video signals on DVD or Blu-ray Disc optical media.

• Removable Media Player/Recorder: The capability to decode and record digitized audio/video signals on DVD or Blu-ray Disc optical media.

DOE welcomes feedback on consideration of the ENERGY STAR® program's identification of base functionality types and additional features in DOE's analysis of product classes for STBs and network equipment. DOE is also seeking feedback on potential methods to combine or reduce the number of product classes, the impact on energy consumption as a result of each of the functionality types and/or features, and market share data on the prevalence of these functionality types and/or features in STBs. Additionally, DOE seeks feedback from interested parties on the following questions:

• Should Cable DTA be a factor in defining a product class? DOE believes this is used for older analog televisions (TVs), which are becoming less common as consumers switch to digital TVs.

• How should tuner types be categorized? Are there significant energy differences between analog and digital tuners?

• Should streaming STBs (e.g., streaming video from a web-based service) be distinguished from service provider IPTV STBs? What, if any, differences are there between those types of STBs? Is the term “video signals” sufficient for including streaming STBs in the potential IPTV product classes?

• Should there be additional features defined due to significant differences in functionality (i.e., performance related feature) that affect energy consumption? Note that for ENERGY STAR, Cable DTA and Cable are two separate definitions despite the fact that they both use cable as the transmission medium.

• Is the Cable STB definition sufficient to include stand-alone DVRs (which include a CableCARD slot to interface with an existing service provider) generally purchased through retail? Should a separate product class exist for stand-alone DVRs?

• Should the Cable STB definition include CableCARD and DOCSIS functionality? Does CableCARD functionality consume energy when a CableCARD is installed but not used, or does it also have to be in use? DOE believes this feature only applies if it is actively decrypting video content during testing.

• Should the Advanced Video Processing feature encompass both encoding and decoding of video content? Would encoding or transcoding require more hardware and energy consumption compared to decoding? Does the presence of Advanced Video Processing significantly affect power consumption when viewing MPEG-2 or analog video?

• Can Advanced Video Processing and High Definition be combined into a single functionality?

• Is it sufficient to define HD as any resolution greater than 720p? Should there be a separate definition for even higher video resolutions?

• Does the capability for multi-room increase the energy consumption of the STB when only one output is connected?

• Does the capability for multi-stream increase the energy consumption of the STB when only one stream is being accessed?

• None of the currently qualified ENERGY STAR products take credit for Removable Media Player or Recording. Are there STBs that currently implement removable media support? Does the presence of this feature increase the energy consumption when not in use (e.g. when the STB is accessing live TV content)?

• DOE further requests that interested parties comment on whether there are any features that would impact some potential product classes of STBs and network equipment differently than others? For example, would DVR functionality tend to increase the energy consumption of satellite STBs and cable STBs similarly?

• Lastly, should DOE consider any other additional features that currently exist or are in development that would significantly affect consumer behavior and/or STB energy consumption (e.g., 3D video processing, ultra high definition)?

One potential energy savings feature of STBs is entering a lower power sleep mode when not performing a primary function (such as watching or recording a television program). Currently, many STBs consume nearly the same amount of energy regardless of whether the devices are performing a primary function. DOE realizes that service providers regularly communicate with deployed devices to maintain network and content security, and to ensure that program guides or on-demand offerings are updated. DOE also understands that some consumers may be opposed to long wake-up times when powering on their devices. Given the amount of potential energy savings, however, DOE is interested in methodologies that reduce energy consumption when the device is not in use while ensuring communication and wake-up times are minimally affected. DOE seeks feedback from interested parties on methodologies that reduce STB energy consumption when not performing a primary function. As an example, a STB could enter a deep sleep mode during off-peak hours (such as the middle of the night) and automatically wake up once every 30 minutes to communicate with the service provider and check for updates. At other times, the device would remain in a light sleep mode when not in use and not require a long wake-up time.

DOE seeks comments, data, and other input into technological, economic, and competitive impacts of using lower power light sleep and deep sleep modes for STBs. DOE also seeks feedback on any other issues related to lower power sleep modes. DOE is particularly interested in technological features that could significantly reduce energy consumption while providing for adequate communication with service providers and minimizing wake-up times when consumers power on their devices.

DOE is also interested in other examples and data of energy-reducing technologies, configurations or product designs, other than sleep modes, that could help improve the efficiency of STBs (e.g., spinning down hard disks, multi-room deployments).

DOE is aware that some service providers offer the use of multi-room setups where a single STB (usually with DVR functionality) is connected to the service provider, and that primary device then feeds video signals to thin-clients in the home through a network connection. This has the ability to save on total household energy consumption by using more efficient thin-clients instead of multiple devices.

In order for DOE to better understand these setups, DOE is seeking more information from interested parties on this topic. In particular:

• DOE is seeking market data on how prevalent multiple STBs are in current homes. For example, how many homes use two STBs? How many homes use three STBs?

• How much more power does a multi-room STB use compared to a thin-client device?

• How much more power does a multi-room STB use compared to a STB without multi-room capability?

• Are generic thin-client STBs capable of connecting to any multi-room STB, or will only specific models of thin-clients work with a given multi-room STB?

In the development of potential energy conservation standards, it may become necessary to adopt standardized user profiles that estimate the average amount of time each day that STBs are in each of their functional modes (e.g. active, standby, and off). It may also become necessary to develop estimates of the amount of time STBs with DVR functionality are in record or playback modes. This usage profile could then be applied to measurements obtained from a test procedure to estimate the typical daily or annual energy consumption of STBs. The ENERGY STAR program uses this methodology in their program. 11 DOE seeks feedback on whether it should adopt the ENERGY STAR usage profile or if an alternative methodology should be used when considering the metric for potential energy conservation standards, such as wattage requirements for each mode. A time-based metric, similar to the method used in ENERGY STAR, may be reasonable as many of the potential energy savings occur based on the time in each mode, and different product classes may have different opportunities for energy savings that could also help a product meet a standard.

As part of analyzing potential energy conservation standards for STBs and network equipment, DOE will develop an engineering analysis, which will characterize the incremental manufacturing cost associated with increasing the efficiency of STBs. As part of this analysis, DOE plans to gather data regarding the efficiency of STBs, run tests on STBs, and perform physical teardowns of STBs. DOE recognizes that there are a variety of functionalities, features, and subscription services that may impact the efficiency of STBs. Therefore, DOE is strongly interested in collecting information from a wide variety of sources on the energy use of different types and configurations of STBs. As part of this analysis, DOE may be required to gain access to a subscription or head-end equipment similar to that of a consumer's access in order to test the STB. DOE is hopeful to gain access to features such as electronic-program-guides, video-on-demand, and pay-per-view for testing.

DOE understands that the nature of subscriptions and leasing agreements make it difficult for DOE to obtain equipment on the commercial market directly for purchase. Consequently, DOE will be reaching out to service providers and STB makers directly to inquire about obtaining the STBs for this analysis and any special equipment necessary for testing.

DOE seeks additional data on STB markets and technologies, including updated National energy use data  12 on STBs by potential product class. These data include numbers of installed devices, unit energy consumption, efficiency ranges, and usage profiles. Projected energy use data include historical and projected annual shipments of STBs, projected unit energy consumption for future models of STBs, and projected usage profiles based on new studies on consumer behavior.

The following discussion topics on testing primarily reference the ENERGY STAR program, but all of the previously referenced industry test procedures were used to help identify the following questions.

Service providers typically install software onto STBs rented to consumers. These STBs are programmed to have security features and constant communication with the service provider and allow customers to access specific content, such as video-on-demand or electronic program guides. Based on initial testing, DOE believes the service provider software can have an impact on the energy consumption of a STB. Thus, DOE is considering that STBs be tested with the appropriate software added. In the event that the same physical STB can be programmed by different service providers, each service provider configuration would be treated as a different device (i.e., a different basic model). DOE would therefore test STBs as deployed in consumers' homes, rather than as shipped by the STB original equipment manufacturers to the service providers. In order to gain a better understanding of the issue, DOE requests feedback on the following:

• What impact does the service provider software have on energy consumption?

• How does service provider software impact idle or sleep behavior?

• How does such software affect any other energy saving features?

• For cable STBs, will there be different energy consumption of a generic STB with CableCARD accessing the digital programming of a service provider versus a programmed device with full two-way communication with the service provider?

ENERGY STAR program specifications do not specify how the video source signal is to be delivered, and implicitly allow STBs to be tested either through a live network (via subscription service) or with a closed network. A closed network includes testing with head-end equipment provided by the service provider and/or manufacturer. Additionally, the CEA test procedures explicitly state that it is not expected that the STB would be connected to a live network. 13

Subscription services (i.e., one type of live network) are more typical of how a consumer would be using the STB. Using a subscription would be simpler to setup for testing, and it would require little involvement by the service provider other than providing the subscription itself. However, DOE has concerns that subscriptions would not be available in all test areas, thus some labs would be physically incapable of testing certain STBs. Additionally, STB behavior may be impacted by geographic location, weather (for satellite connection), and time of day. Subscriptions themselves can vary depending on the type chosen for testing as service providers generally have different package choices that could be accessed by the same STB hardware. Finally, video format may not be as controllable through a subscription, which may be required for testing (see Section 0 of this document).

Closed network testing can solve some of the repeatability issues for testing. However, it requires proprietary hardware and software from the service provider. This equipment can be large and costly to use, and may be very difficult to setup and configure. DOE also has concerns that the programmed head-end equipment and physical setup may not be realistic due to the lack of access to certain features, which may impact energy consumption of the STB.

Because of the potential difficulties in using a closed network, DOE is considering that STBs be tested via subscription service only. DOE is also considering allowing closed network testing and may need to specify head-end requirements in this case. DOE would like feedback from interested parties on these two methods. Specifically,

• How will STB behavior compare between closed network testing and live network testing?

• How will STBs with subscription service be affected by geographic location and time of day?

• How will energy usage of the STB be affected by the subscription package selected?

• Are there any obstacles with service providers providing head-end equipment to labs for testing STBs?

• Are there any additional factors that should be considered when deciding between closed network and live network testing methods?

• Are there other potential test setups that should be considered?

The ENERGY STAR test procedure describes three reference channels to be used for testing STBs. They are as follows: 14

(1) Reference Channel A: Network television channel, standard definition (SD) format, minimum 480i resolution.

(2) Reference Channel B: Live or recorded sports channel;

a. If the STB is HD-capable, this channel shall be in HD format, minimum 720p resolution.

b. If the STB is not HD-capable, this channel shall be in SD format, minimum 480i resolution.

(3) Reference Channel C: 24-hour news channel, standard definition (SD) format, minimum 480i resolution.

DOE has initial concerns with the ENERGY STAR test procedure's lack of a video signal standard for repeatability, as the video source may impact the STB energy consumption. However, a subscription based testing would not necessarily have control of the video content. Due to differences in video processing, DOE is also concerned that the chosen video format will have an impact on energy consumption of the STB, and that a minimum video resolution would not be sufficient to guarantee a repeatable test. For high definition format, one lab may test at 720p, and another lab may use 1080p, which could result in different recorded energy consumptions. Additionally, some STBs may be preconfigured to output a set video resolution. Thus, any video input source that differed from the output resolution would require additional video processing. For example, using a 720p input signal may require more energy when converting to 1080i compared to a native 1080i input signal.

DOE is also concerned that there are additional parameters that may need to be specified if using a controlled test signal. Frame rate may also need to be specified as there could potentially be differences between 60 frames per second video sources versus 24 frames per second. Video bit rates may also need to be specified as lower bitrates would likely require less energy at the expense of lower quality video. Finally, the video codec should be specified for repeatability. MPEG-4 decoding may require additional hardware compared to MPEG-2.

Because different service providers may provide different video formats to their customers, DOE is considering an alternative method where the tester can randomly choose a video source. The chosen channel and video specifications would need to be reported or measured, and energy consumption would be normalized to make different video formats comparable. For example, it is expected that a STB decoding video at 5 megabits per second would use less energy than a STB decoding video at 10 megabits per second. DOE would attempt to normalize out the bitrate aspect of energy consumption in setting standard levels. DOE is aware that this method may not be as repeatable as creating a specific test signal, but it will ensure some level of control for video content and source while still simulating the consumer experience.

DOE is also considering specifying minimum requirements for video content for testing and/or using a standard test video source if it is technically feasible. DOE seeks feedback from interested parties on this subject. In particular:

• How much modification do service providers make to content providers' signals? Does a specific channel use similar frame rates, encoding, and bit rates across different service providers or locations? DOE does not wish for service providers to lower the quality of video in order to meet potential energy standards.

• For a given service provider, are there any regional differences in video format? For example, would an HD broadcast of a specific channel be delivered at an identical video format across all geographic locations?

• How much variance in energy consumption would be expected based on the video content? Would sports content (more dynamic) have significant differences in energy consumption compared to news content (more static)?

• Is it possible to determine or measure the frame rate, bit rate, and video format being received by the STB? If so, how is this done?

• If labs are able to test with a controlled video source, what parameters most impact energy consumption? DOE has identified resolution, format, frame rate, and bit rate. Are these sufficient, or are there other parameters that should be specified? Are any of these parameters irrelevant to energy consumption?

The ENERGY STAR test procedure includes testing DVR functionality. 15 The DVR alters STB behavior and consumer behavior by allowing the consumer to record content, watch offline content, and pause/rewind/fast-forward live broadcasts. This behavior is significantly different from a standard STB (also known as a receiver), which is primarily used to watch live video. The ENERGY STAR test procedure specifies that live TV testing includes pausing (5% of test time), fast forward (10% of test time), and rewind (10% of test time), and watching video for the remaining 75% of the time. It also specifies energy consumption for recording and playing back stored video.

DOE believes that energy consumption may depend on the order that these operations are performed as well as the number of transitions between modes. Additionally, DVR STBs usually have multiple speeds for fast forwarding and rewinding that may impact energy usage.

DOE is considering that each DVR operation mode be measured in a separate test for fixed test time durations. For example, the tester could measure power for 5 minutes while rewinding video, measure power for 5 minutes while playing video, and measure power for 5 minutes while fast-forwarding video. The weighting for energy consumption can be incorporated into the final efficiency metric. DOE is also considering including multiple speeds for fast-forward and rewind for testing. DOE seeks feedback from interested parties on handling DVR testing.

A low noise block (LNB) is used in conjunction with a satellite STB to improve signal reception. It can have a separate power supply, but some LNBs draw power from the STB coaxial connection. The ENERGY STAR test procedure explicitly excludes the energy consumption of the LNB, 16 as does the CEA test procedure. 17

DOE is considering including LNB energy consumption for satellite STBs, as the LNB is providing required functionality, and would like to identify what factors impact LNB energy consumption and whether these factors can be controlled in a lab scenario. Accordingly, DOE seeks feedback from interested parties on this topic or any of the following questions:

• How much power does the LNB consume compared to the STB?

• Does LNB energy consumption vary significantly based on the received signal or noise?

• Is it possible to test the STB with the LNB disabled or disconnected?

• Are there any known methods for accurately measuring the LNB power to exclude it from the STB energy consumption?

• What other factors influence the energy consumption of LNBs?

• Can all satellite STBs use an independently powered LNB as a means to separate LNB power from the STB?

The time, date, and location of the public meeting are listed in the DATES and ADDRESSES sections at the beginning of this RFI. To attend the public meeting, please notify Ms. Brenda Edwards at (202) 586-2945. As explained in the ADDRESSES section, foreign nationals visiting DOE Headquarters are subject to advance security screening procedures.

Any person who has an interest in the topics addressed in this RFI, or who is a representative of a group or class of persons that has an interest in these issues, may request an opportunity to make an oral presentation at the public meeting. Requests should be emailed to Ms. Brenda Edwards at Brenda.Edwards@ee.doe.gov. Persons who wish to speak should include their contact information and an attached file that describes the nature of their interest in this RFI and the topics they wish to discuss. DOE requests persons selected to make an oral presentation to submit an advance copy of their statements by January 19, 2011. DOE may permit persons who cannot supply an advance copy of their statement to participate, if those persons have made advance alternative arrangements with the Building Technologies Program. As necessary, requests to give an oral presentation should ask for such alternative arrangements.

DOE will designate a DOE official to preside at the public meeting and may also use a professional facilitator to aid discussion. The meeting will not be a judicial or evidentiary-type public hearing, but DOE will conduct it in accordance with section 336 of EPCA (42 U.S.C. 6306). There shall not be discussion of proprietary information, costs or prices, market share, or other commercial matters regulated by U.S. anti-trust laws. A court reporter will be present to record the proceedings and prepare a transcript. The public meeting will be conducted in an informal, conference style. DOE reserves the right to schedule the order of presentations and to establish the procedures governing the conduct of the public meeting. DOE will present summaries of comments received before the public meeting, allow time for presentations by participants, and encourage all interested parties to share their views on issues affecting this RFI. Each participant will be allowed to make a prepared general statement (within time limits determined by DOE), before the discussion of specific topics. DOE will permit other participants to comment briefly on any general statements.

At the end of all prepared statements on each specific topic, DOE will permit participants to clarify their statements briefly and comment on statements made by others. Participants should be prepared to answer DOE's and other participants' questions. DOE representatives may also ask participants about other matters relevant to this RFI. The official conducting the public meeting will accept additional comments or questions from those attending as time permits. The presiding official will announce any further procedural rules or modification of these procedures that may be needed for the proper conduct of the public meeting. After the public meeting, interested parties may submit further comments on the proceedings as well as on any aspect of the RFI until the end of the comment period. DOE will make the entire record of this proceeding, including the transcript from the public meeting, available on the DOE Web site.

DOE welcomes comments on all aspects of this RFI and on other relevant issues that participants believe would affect test procedures and energy conservation standards applicable to STBs and network equipment.

After the close of the comment period, DOE will begin collecting data, conducting the analyses, and reviewing the public comments. These actions will be taken to aid in the development of a test procedure notice of proposed rulemaking (NOPR) and energy conservation standard NOPR for STBs and network equipment.

DOE considers public participation to be a very important part of the process for developing test procedures and energy conservation standards. DOE actively encourages the participation and interaction of the public during the comment period in each stage of the rulemaking process. Interactions with and between members of the public provide a balanced discussion of the issues and assist DOE in the rulemaking process. Anyone who wishes to be added to the DOE mailing list to receive future notices and information about this rulemaking should contact Mr. Jeremy Dommu at (202) 586-9870, or via email at Jeremy.Dommu@ee.doe.gov.

Comments Invited

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.

Communications should identify both docket numbers (FAA Docket No. FAA 2011-1313 and Airspace Docket No. 11-AWP-17) and be submitted in triplicate to the Docket Management System (see ADDRESSES section for address and phone number). You may also submit comments through the Internet at http://www.regulations.gov.

Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2011-1313 and Airspace Docket No. 11-AWP-17”. The postcard will be date/time stamped and returned to the commenter.

All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9 a.m. and 5 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA 98057.

Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.

The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E surface airspace and Class E airspace extending upward from 700 feet above the surface at Douglas, AZ. Additional controlled airspace is necessary to accommodate aircraft using VHF Omni-Directional Radio Range/Distance Measuring Equipment VOR/DME Global Positioning System (GPS) standard instrument approach procedures at the Bisbee Douglas International Airport, Douglas, AZ. Decommissioning of the Cochise VORTAC has made this action necessary and would enhance the safety and management of aircraft operations at airport. The geographic coordinates of the airport would also be updated to coincide with the FAA's aeronautical database.

Class E airspace designations are published in paragraph 6002 and 6005, respectively, of FAA Order 7400.9V, dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in this Order.

The FAA has determined this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed 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 proposed rule, when promulgated, would 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, describes the authority for 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 the 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 would modify controlled airspace at Bisbee Douglas International Airport, Douglas, AZ.

Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR Part 71 as follows:

The Commission has requested comment on Proposed Rule 127B under the Securities Act of 1933 (“Securities Act”) in the ABS Conflicts Proposal to implement Section 621 of the Dodd- Frank Act. 1 Proposed Rule 127B under the Securities Act would prohibit certain persons who create and distribute an asset-backed security, including a synthetic asset-backed security, from engaging in transactions, within one year after the date of the first closing of the sale of the asset-backed security, that would involve or result in a material conflict of interest with respect to any investor in the asset-backed security. The proposed rule also would provide exceptions from this prohibition for certain risk-mitigating hedging activities, liquidity commitments, and bona fide market-making. The ABS Conflicts Proposal was published in the Federal Register on September 28, 2011.

The Commission originally requested that comments on the ABS Conflicts Proposal be received by December 19, 2011, including comment about any potential interplay  2 between Proposed Rule 127B and the “Volcker Rule Proposal.”  3 The Volcker Rule Proposal would implement Section 619 of the Dodd-Frank Act concerning prohibitions and restrictions on proprietary trading and certain interests in, and relationships with, hedge funds and private equity funds. The Volcker Rule Proposal was published in the Federal Register on November 7, 2011 and the comment period for that proposal ends on January 13, 2012.

In an effort to provide the public with a better opportunity to consider any potential interplay between the ABS Conflicts and Volcker Rule Proposals, the Commission has determined to provide the public additional time to consider simultaneously the ABS Conflicts Proposal and the Volcker Rule Proposal. This extended opportunity to submit comprehensive comments regarding the ABS Conflicts Proposal and any potential interplay with the Volcker Rule Proposal would benefit the Commission in its consideration of any final rules. Therefore, the Commission is extending the comment period for the ABS Conflicts Proposal to January 13, 2012, to coincide with the end of the Volcker Rule Proposal's comment period. The Commission would consider a further extension of the ABS Conflicts Proposal comment period if the Volcker Rule Proposal comment period were extended beyond January 13, 2012.

Background

The correction notice that is the subject of this document is under section 382 of the Code.

As published, the notice of proposed rulemaking (REG-149625-10) contains errors that may prove to be misleading and are in need of clarification.

Accordingly, the publication of notice of proposed rulemaking (REG-149625-10), which was the subject of FR Doc. 2011-30290, is corrected as follows:

1. On page 72364, column 3, in the preamble, under the paragraph heading “D. Clarification of § 1.382-2T(j)(3)”, eleventh line, the language “regard to § 1.382-2T(h)(i)(A)) or a first” is corrected to read “regard to § 1.382-2T(h)(2)(i)(A)) or a first”.

2. On page 72364, column 3, in the preamble, under the paragraph heading “D. Clarification of § 1.382-2T(j)(3)”, last line of the paragraph, the language “2T(h)(i)(A).” is corrected to read “2T(h)(2)(i)(A).”.

The correction notice that is the subject of this document is under sections 6045, 6045A and 6045B of the Internal Revenue Code.

As published, the notice of proposed rulemaking and notice of public hearing (REG-102988-11) contains an error that may prove to be misleading and is in need of clarification.

Accordingly, the publication of a notice of proposed rulemaking and notice of public hearing (REG-102988-11)), which was the subject of FR Doc. 2011-30383, is corrected as follows:

The correction notice that is the subject of this document is under section 67 of the Code.

As published, a cancellation of notice of public hearing on proposed rulemaking (REG-128224-06) contains an error that may prove to be misleading and is in need of clarification.

Accordingly, the publication of cancellation of notice of public hearing on proposed rulemaking (REG-128224-06), which was the subject of FR Doc. 2011-31855, is corrected as follows:

On page 77454, column 3, in the preamble, under the subject of the headings, the title “New Markets Tax Credit Non-Real Estate Investments; Hearing Cancellation” is corrected to read “Section 67 Limitations on Estates or Trusts; Hearing Cancellation”.

Posting of Public Comments. All comments received are part of the public record and available for public inspection online at http://www.regulations.gov. Comments may include personal identifying information voluntarily submitted by the commenter. When found, personal identifying information will not be posted online but will be maintained in the agency's public docket file.

On July 11, 2011 the President issued Executive Order 13579 “Regulation and Independent Regulatory Agencies.” The order states that each independent regulatory agency should prepare a plan for the periodic review of its existing significant regulations to determine those regulations that are outdated, unnecessary or ineffective. The review enables the agency to modify or repeal a rule to increase the effectiveness of the regulatory program or lessen unnecessary burdens caused by the rule. This order highlights the importance of maintaining a culture of retrospective review of an agency's regulations.

Pursuant to Executive Order 13579, the Parole Commission has developed a preliminary plan for a review of its regulations. The Commission primarily performs law-enforcement functions in releasing an offender from a prison term imposed by a sentencing judge, setting conditions of release, revoking the release if the offender violates the release conditions or terminating the sentence early for good conduct on parole supervision. The Commission's rules define the procedures and standards used to carry out the functions described above. Many of the rules incorporate statutory requirements. Other rules, such as the paroling policy guidelines, reflect policy choices made by the Commission members within the broad grant of authority given by Congress on executing the Commission's functions. The application of the rules may affect the lives of individual persons and the general public welfare, but the Commission's rulemaking and actions do not have a significant impact on economic entities and businesses.

Over the last ten years, the Commission has issued 13 publications of final rules and 5 publications of interim rules that have yet to be promulgated as final rules. The majority of this rulemaking pertained to: Implementing new legislation and court decisions; adopting procedural rules on internal voting requirements and using new technology in conducting hearings; streamlining the revocation process for parole violators who have committed non-criminal violations of release; and eliminating or clarifying rules that are outdated or confusing.

The Commission's preliminary plan for the regulatory review includes all rules promulgated by the Commission and all notes and procedures in its Rules and Procedures Manual (June 30, 2010 edition). The ambitious scope of this effort may have to be adjusted depending on the workload of those staff members who are charged with carrying out the review. The Commission's review will extend to proposed rules and interim rules that have not been made final rules.

In 2004 a Commission working group, headed by the former chief of staff, undertook a project to rewrite the Commission's Rules and Procedures Manual. The purpose of the project was to simplify the rules and instructions in the manual, eliminate obsolete provisions and make the manual easier to use. Had this effort been pursued to its completion, the Commission would have engaged in significant rulemaking. But, as often happens, the press of agency business and the setting of other priorities overtook the effort. Nonetheless, this working group achieved significant progress in redrafting a large portion of the manual and its work will be the foundation for the preliminary plan of regulatory review that the Commission announces with this publication.

The Commission Chairman has appointed an agency working group that will execute the review of the Commission's rules. Every Commission section is represented on the working group, which is monitored by Commissioner J. Patricia Smoot, and chaired by the Commission's General Counsel, Rockne Chickinell. The group's task is to determine whether a rule is outmoded, ineffective or imposes costs that are disproportionate to the benefits of the rule, and make recommendations to the Commission on the modification, addition or removal of rules. The group will also review the rules for clarity and readability.

The review will begin with those rules and procedures that pertain to imposing conditions of release for an offender. Congress instructed the Commission that the release conditions “be sufficiently specific to serve as a guide to supervision and conduct.” 18 U.S.C. 4209(b). So it is particularly important that the release conditions are clear and understandable to the offender under supervision. Also, unduly burdensome release conditions may be counterproductive to the offender's success on supervision. The Commission substantially revised its standard release conditions through an interim rule in 2003. 68 FR 41696-41714 (July 15, 2003). The retrospective review will include an analysis of whether the revisions of 2003 need to be updated and whether the manual should provide guidance as to the parsimonious application of release conditions that are not required by law.

The review will proceed to the rules and procedures that govern the parole and supervised release revocation process. Most of the Commission's workload consists of responding to reports of violations, issuing violator warrants and conducting revocation proceedings. Carrying out the revocation function involves a significant number of participants outside the Commission, including supervision officers, deputy U.S. Marshals, police officers, private attorneys and public defenders, witnesses from the general public and the offenders. The retrospective review of revocation rules and procedures should benefit a broad range of the persons who participate in the Commission's activities. The Commission also recognizes that the parolee who is facing possible revocation has a substantial interest in a process that reduces the incidence of error that may be caused by confusing or ambiguous rules and instructions.

The review will end with an analysis of the rules and procedures covering parole release determinations and internal procedures such as voting requirements by hearing examiners and Commission members.

In its examination the working group will pay particular attention to those rules and procedures that: Place high costs or burdens on the public, require outdated reporting practices, affect a large group of persons or entities, overlap with or duplicate other rules, are obsolete given changes in laws or other circumstances or have been the subject of requests for rulemaking.

In addition to this request for comment, the Commission will send out notices to interested organizations seeking the views and comments on the continued relevance and effectiveness of the Commission's rules. Interested organizations included in this outreach effort are correctional and parole supervision entities such as the Federal Bureau of Prisons, the District of Columbia Court Services and Offender Supervision Agency, the U.S. Probation Service and organizations frequently representing the interests of federal and District of Columbia offenders such as Federal Defender's offices in Philadelphia, Pennsylvania and Oklahoma City, Oklahoma, the DC Public Defender Service, and CURE, Inc.. At any time during the review period, the public may provide their views and recommendations to the working group by writing the Commission at U.S. Parole Commission, attn: USPC Rules Group, 90 K Street, 3rd Flr., Washington, DC 20530 or sending an email to USPCRulesGroup@usdoj.gov. If the Commission decides to proceed with rulemaking at any stage of the retrospective review, the Commission will follow the normal rulemaking process, usually with a 60-day notice and public comment period for proposed rules. The working group will analyze the public comment for the Commission's review and recommend responses to the comments submitted. The working group will then forward their recommendation on final rulemaking to the Commission for a vote at the open session of a Commission business meeting. Any interested person or organization may observe the Commission's discussion of a rule change at the open business meeting.

As the working group conducts its review, the Commission will report its progress on the agency's Web site, including any rulemaking initiatives taken by the Commission in response to the working group's review. The Commission's goal is to complete its retrospective review by September 30, 2013.

The Commission's effort to sustain a culture of review and analysis of its rules and procedures will not end with the completion of the retrospective review required by the executive order. During the retrospective review, the Commission will rely on the working group to review any new regulatory initiative for issues such as the need for the rule, the burden placed on the public and criminal justice agencies by the rule, any alternatives to the rule and the clarity of the proposed wording of the rule. Even after the retrospective review ends, the Commission intends to maintain the working group for the periodic review of its rules and manual provisions and to analyze new proposed rules and procedures.

We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided.

If you submit a comment, please include the docket number for this rulemaking (USCG-2010-0929), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online (via http://www.regulations.gov ) or by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online via http://www.regulations.gov, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the Docket Management Facility. We recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.

To submit your comment online, go to http://www.regulations.gov, click on the “submit a comment” box, which will then become highlighted in blue. In the “Document Type” drop down menu select “Proposed Rule” and insert “USCG-2010-0929” in the “Keyword” box. Click “Search” then click on the balloon shape in the “Actions” column. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and may change the rule based on your comments.

To view comments, as well as documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, click on the “read comments” box, which will then become highlighted in blue. In the “Keyword” box insert “USCG-2010-0929” and click “Search.” Click the “Open Docket Folder” in the “Actions” column. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. We have an agreement with the Department of Transportation to use the Docket Management Facility.

Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

We do not now plan to hold a public meeting. But, you may submit a request using one of the four methods specified under ADDRESSES . Please explain why you believe a public meeting would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register.

The legal basis for the proposed rule is 33 U.S.C. 471, 1221 through 1236, 2030, 2035, and 2071; 33 CFR 1.05-1; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to define anchorage grounds.

This proposed rule would expand the designated special anchorage areas in Newport Bay Harbor, and remove other anchorage grounds, to align with the actual placement of existing mooring areas and reflect the way the harbor is currently used.

Due to enhanced anchorage population over the years, the mooring areas being used in Newport Bay Harbor are nominally larger than the special anchorage areas originally charted in 33 CFR 110.95. As moorings were added or overhauled, the new moorings would fall outside the existing boundaries, resulting in moorings lying outside the charted areas. Similarly, the anchorage grounds designated in 33 CFR 110.212 were originally used as temporary overflow anchorages, but are now used regularly. Harbor users have been accustomed to this placement for the last 10 years.

The Mooring Master Plan Subcommittee of the City of Newport Harbor Commission led an outreach campaign involving a series of public meetings about aligning the anchorage regulations with actual harbor use patterns, and we understand that the subcommittee did not receive any opposition from the waterway users. After these public meetings, the City of Newport asked the Coast Guard to amend its anchorage regulations.

The Coast Guard proposes to realign the boundaries in order to reflect the way the harbor currently is used. The proposed rule would remove § 110.212 and the three anchorage grounds found therein (anchorages C-1, C-2, C-3). The area covered by those anchorages would be incorporated into the special anchorage area regulations at § 110.95. Anchorage C-1 would be incorporated into area B-1 under revised § 110.95(m), and anchorages C-2 and C-3 would be incorporated into area A-11 under revised § 110.95(k). An image of the proposed anchorage areas is available in the docket.

The enlargement of the special anchorage areas does not pose any waterway or navigational hazard, or restrict harbor use in any way. The Army Corps of Engineers has been consulted and did not have any opposition. We anticipate that this proposed rule would have no impact on fishing or boating because the proposed amendment would adjust the lines to fit the current layout of moorings in Newport Harbor. Small craft are not restricted in the harbor.

Berthing and anchoring in Newport Harbor also is regulated by Orange County ordinance and the City of Newport's municipal code. The enlargement of the special anchorages does not impact these laws; for the convenience of the reader we have included a note in the proposed rule referencing local municipal codes. This note consolidates the multiple notes currently in the section. Finally, this proposed rule would update the other provisions of § 110.95 to designate anchorage areas using geographic coordinates rather than channel lights and other points in the harbor.

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

This proposed 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, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. The Coast Guard proposes to realign anchorage boundaries in order to reflect the way the harbor currently is used. The enlargement of the anchorages does not restrict harbor use in any way.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. This proposed rule would affect the following entities, some of which might be small entities: The owners or operators of commercial and recreational vessels intending to transit or anchor in the affected area. The impact to these entities will not, however, be significant since this area will encompass only a small portion of the waterway and vessels can safely navigate around the anchored vessels.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

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

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

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

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

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

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

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

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

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

We have analyzed this proposed 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 made a preliminary determination 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 proposed rule involves changing the size of special anchorage areas. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 110 as follows:

Table of Contents for Preamble I. Public Participation and Request for Comments A. Submitting Comments B. Viewing Comments and Documents C. Privacy Act D. Public Meeting II. Abbreviations III. Background IV. Discussion of Proposed Rule A. Proposed Revisions to § 127.009 B. Proposed Addition of § 127.010 V. Regulatory Analyses A. Regulatory Planning and Review B. Small Entities C. Assistance for Small Entities D. Collection of Information E. Federalism F. Unfunded Mandates Reform Act G. Taking of Private Property H. Civil Justice Reform I. Protection of Children J. Indian Tribal Governments K. Energy Effects L. Technical Standards M. Environment I. Public Participation and Request for Comments

We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided.

If you submit a comment, please include the docket number for this rulemaking (USCG-2011-0227), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. We recommend that you include your name and a mailing address, an email address, or a phone number in the body of your document so that we can contact you if we have questions regarding your submission.

To submit your comment online, go to http://www.regulations.gov, and type “USCG-2011-0227” in the “Keyword” box. If you submit comments by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope.

We will consider all comments and material received during the comment period and may change this proposed rule based on your comments.

To view comments, as well as documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, click on the “read comments” box, which will then become highlighted in blue. In the “Enter Keyword or ID” box insert “USCG-2011-0227” and click “Search.” Click the “Open Docket Folder” in the “Actions” column. If you do not have access to the Internet, you may view the docket online by visiting the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. We have an agreement with the Department of Transportation to use the Docket Management Facility.

Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

We do not now plan to hold a public meeting, but you may submit a request for one to the docket using one of the methods specified under ADDRESSES . In your request, explain why you believe a public meeting would be beneficial. If we determine that a public meeting would aid this rulemaking, it will hold one at a time and place announced by a later notice in the Federal Register .

Under existing regulations contained in 33 CFR part 127, an owner or operator intending to build a new waterfront facility handling liquefied natural gas (LNG) or liquefied hazardous gas (LHG), or planning new construction to expand or modify marine terminal operations in an existing facility that would result in an increase in the size and/or frequency of LNG or LHG marine traffic on the waterway associated with the proposed facility or modification to an existing facility, must submit a letter of intent to the Captain of the Port (COTP) of the zone in which the facility is or will be located. The COTP then issues a Letter of Recommendation (LOR) as to the suitability of the waterway for LNG or LHG marine traffic related to the facility.

The LOR is intended to provide an expert, unbiased recommendation as to whether the waterway and port infrastructure can safely and securely support the anticipated increase in maritime traffic associated with the new or modified facility. Prior to May 2010, the COTP issued the LOR to the owner or operator of the facility as well as to the State and local government agencies with jurisdiction, but the Coast Guard changed that process in a rule updating the letter of intent and LOR regulations (75 FR 29420, Revision of LNG and LHG Waterfront Facility General Requirements). Currently, the Coast Guard issues the LOR to the Federal, State, or local government agency having jurisdiction for siting, construction, and operation of the waterfront facility (referred to in this document as the “jurisdictional agency”), and sends a copy to the owner or operator of the proposed facility.

Several issued LORs have invited the recipient to request reconsideration of the LOR pursuant to 33 CFR 127.015, which provides that “[a]ny person directly affected by an action taken under this part may request reconsideration by the Coast Guard officer responsible for that action.” The process set forth in § 127.015 is the same that an owner or operator would use to appeal agency actions described elsewhere in Part 127, such as a COTP's Order to suspend operations. The use of § 127.015 to request reconsideration of LORs, however, has led to confusion about the nature and proper role of the LOR. This is in part because the words “action” and “final agency action” in § 127.015 create confusion as to whether the LOR is an agency action for purposes of the Administrative Procedure Act (5 U.S.C. 551 et seq.). While we believe LORs should be subject to intra-agency review, we did not intend to suggest that an LOR is an agency action or that it conveys a right or obligation.

The LOR is not an agency action as that term is defined by the Administrative Procedure Act or understood in the context of enforceable legal actions. To constitute agency action for purposes of the Administrative Procedure Act, an activity must constitute, in whole or in part, an agency rule, order, license, sanction, relief, or the equivalent or denial thereof, or failure to act (5 U.S.C. 551(13)). The LOR is none of these. The LOR neither entitles nor forbids an owner or operator to construct or modify an LNG or LHG facility—the Coast Guard has no authority to site or license waterfront facilities handling LNG or LHG. Rather, the Coast Guard provides its LOR to an agency that does have that authority—the jurisdictional agency—to inform that agency's review of the siting, construction, or operation of a facility. The LOR is a recommendation, and is not legally enforceable on or by any agency or person, including the Coast Guard.

The Coast Guard does take agency action with respect to LNG and LHG facilities when it enforces its rules addressing the operation, maintenance, personnel training, firefighting, and security of the marine transfer area of waterfront facilities that handle LNG or LHG cargos. The Coast Guard COTP also may issue a COTP Order directing vessel operations, and although such an Order would be directed to the vessel's owner or operator, it could impact the operation of an LNG or LHG facility. Enforcement of these Coast Guard regulations constitutes agency action, follows administrative processes set out in Coast Guard regulations, and may be appealed in court at the completion of the administrative processes. For example, a Coast Guard action enforcing § 127.013, “Suspension of transfer operations,” may be appealed under § 127.015, and a COTP Order directing vessel operations under 33 CFR 160.111 may be appealed under 33 CFR 160.7. An LOR is unrelated to the enforcement described above. It is not a precursor to or a basis for COTP Orders or Part 127 enforcement. The LOR is only a recommendation providing the jurisdictional agency with the benefit of the Coast Guard's expertise on waterway safety and security; it documents the COTP's recommendation within another agency's permitting or approval process. The authority to approve or disapprove the siting, construction, or modification of an LNG or LHG facility lies with the jurisdictional agency, and not with the Coast Guard. 1

As discussed above, we believe that some of the past confusion regarding the nature of LORs stems from the Coast Guard's use of 33 CFR 127.015 for LOR reconsiderations. The process in § 127.015 is designed for appeals of agency actions taken under the authority of Part 127, and using that same process for internal reconsideration of LORs inadvertently caused confusion between the two. In particular, § 127.015 applies to “[a]ny person directly affected by an action taken under this part,” and using that language in reference to an unenforceable recommendation is inapt. The Coast Guard seeks to resolve the resulting confusion and, further, believes the process in § 127.015 is inappropriately complicated and lengthy in light of the LOR's role as a recommendation to another agency in the context of that agency's permitting process. The LOR is intended to inform the jurisdictional agency's process, and therefore should be available early in that process. A reconsideration process that results in revisions to the LOR after the jurisdictional agency's decision does not serve the purpose of the LOR.

The purpose of the LOR is to assist the agencies having jurisdiction over the siting, construction, and operation of LNG and LHG facilities. The Ports and Waterways Safety Act of 1972, as amended (33 U.S.C. 1221 et seq.) (PWSA) authorizes the Secretary of the Department in which the Coast Guard is operating to implement regulations to, among other things, reduce the possibility of vessel or cargo loss, or damage to life, property, or the marine environment. See 33 U.S.C. 1231. The Secretary of Homeland Security delegated this authority to the Coast Guard (Department of Homeland Security Delegation 0170.1). Issuing LORs with regard to proposed new or modified LNG or LHG facilities is one of many methods by which the Coast Guard furthers its missions under the PWSA. To improve the existing process, we propose to clarify the purpose of LORs and revise procedures by which facility owners or operators and State or local governments in the vicinity of a facility may request reconsideration of an issued LOR. The proposed reconsideration procedures, if finalized, would apply only to LORs issued after the effective date of the rule.

We considered eliminating reconsideration of the LOR in order to avoid the confusion described above and eliminate procedural delay. We believe, however, that consistency and governmental transparency are best served if a defined set of stakeholders has the ability to ask the Coast Guard to reconsider its recommendation. This is in keeping with past and current process under § 127.015, in which the Coast Guard has responded to requests for reconsideration from facility owners and operators, and State or local governments, as the practical analogue to “persons directly affected.”

As discussed above, the existing process for reconsideration can create confusion and delay. We therefore propose to add a new § 127.010 to 33 CFR part 127 to provide a separate process for the reconsideration of LORs issued after the effective date of this rule. To facilitate the use of this new section, we also propose to revise § 127.009 to clarify the scope of the LOR and the persons who may request reconsideration.

We propose to renumber the existing text of § 127.009, such that all of the existing text would be contained in paragraph (a). We propose to then add a paragraph to § 127.009 explaining that an LOR is only a recommendation from the COTP to the jurisdictional agency, and does not constitute agency action for the purposes of § 127.015 or the Administrative Procedure Act.

We also propose to indicate in this section that reconsideration of LORs would follow the process set forth in proposed § 127.010. To avoid disrupting any reconsiderations now in progress, and to prevent any perceived disadvantage to those who were issued an LOR indicating that reconsideration under § 127.015 was available, the Coast Guard would continue to process the reconsiderations of issued LORs under § 127.015. Only LORs issued after the effective date of any resulting final rule would follow the new process set out in proposed § 127.010. Processing issued LORs under § 127.015, however, does not alter the fact that all LORs are mere recommendations to the jurisdictional agency, and none are agency actions as outlined in the Administrative Procedure Act.

As set forth in the proposed revision to § 127.009, the facility owner or operator could request reconsideration of the LOR, as could a State or local government in the vicinity of the facility. Other interested persons would submit comments and relevant information to the jurisdictional agency for that agency's consideration during its permitting process. This is consistent both with the Coast Guard's submission of its own recommendation to the jurisdictional agency for that agency's consideration, and with the Coast Guard's past and current practice of receiving requests for reconsideration from a limited set of persons under § 127.015.

In general, those interested in expressing their agreement or disagreement with the Coast Guard's recommendation would submit their own comments and information to the jurisdictional agency, so that the agency can weigh all the information before it makes a decision. We believe, however, that it is important to provide for additional discussion with the facility owner or operator and the State or local governments in the vicinity of the facility. These entities possess unique information regarding safety and security issues affecting the facility and waterway. The facility owner or operator often is aware of, or even the source of, anticipated changes in vessel traffic, navigation obstructions, and other factors the Coast Guard considers in issuing the LOR. State and local governments play an important role in protecting public safety, and are essential in helping the Federal government plan and prepare for emergencies; they also may be aware of safety and security resources and challenges. Therefore, the proposed rule would provide an avenue for these entities to request that the Coast Guard reconsider its LOR. We invite the public to comment on the scope of this exception, and specifically on whether it should be extended in the final rule to additional categories of persons. If you provide comments on this topic, please explain the reasons for your comments.

In addition to the above changes related to new § 127.010, we propose revising § 127.009(a)(5), the last item in the list of considerations the COTP takes into account when developing the LOR. The proposed revision is more specific than the current phrase, “[o]ther safety and security issues identified,” and more accurately reflects the COTP's ability to consider a broad range of safety and security issues that may vary from waterway to waterway.

As proposed in this new section, the reconsideration of an LOR would begin with the submission of a written request to the COTP who issued the LOR, describing why the COTP should reconsider his or her recommendation. The explanation would focus on the waterway safety and security topics set forth in §§ 127.007 and 127.009, as these describe the limited scope of the LOR. The person requesting reconsideration would send a copy of the request to the agency to which the LOR was issued, to inform the agency with jurisdiction for siting, construction, or operation of the facility that the COTP has been asked to reconsider the LOR.

The COTP would review the request and the LOR, and either confirm or revise the recommendation. The COTP would send either a written confirmation or a revised LOR to the jurisdictional agency, with copies to the requester and to the facility owner or operator. This would ensure that all those who received the original LOR, and the copy of the request for reconsideration, also receive the written confirmation or revised LOR. A facility owner or operator, or State or local government in the vicinity of the facility, who wished to request reconsideration of the revised LOR, could do so by following the same procedures for requesting reconsideration of the original LOR.

Documents the Coast Guard provides to jurisdictional agencies concerning LOR requests for reconsideration and appeals are normally made available to the public through the jurisdictional agency's docket management system.

If the COTP confirms the recommendation after reconsideration, the person who requested reconsideration could seek the opinion of the COTP's District Commander. The request would have to explain why the District Commander should review the COTP's recommendation, and the requester must also send a copy to the jurisdictional agency to which the LOR was issued.

The District Commander would review the LOR and associated documents, and either confirm the LOR or instruct the COTP to reconsider the LOR. As in the earlier stage, the District Commander would send a written notification to the jurisdictional agency, with copies to the requester and the facility owner or operator. The District Commander's written confirmation would end the reconsideration process; the requester could not request review by another officer in the chain of command. We propose to limit reconsideration to the District Commander level because the COTP and the District Commander have the most expertise with the specific local waterway.

If the District Commander instructed the COTP to reconsider the LOR, and that reconsideration resulted in a revised LOR, then a facility owner or operator, or State or local government in the vicinity of the facility, could request reconsideration of the revised LOR by following the same procedures for requesting the reconsideration of the original LOR.

The proposed rule could result in more than one person requesting reconsideration of an LOR, such that multiple reconsiderations would be “in progress” at one time. The Coast Guard would consolidate multiple requests when appropriate.

We do not propose a specific timeline for submitting or processing requests, but in general we would expect to receive requests for reconsideration, if any, soon after issuing the LOR, and we would expect to resolve them as promptly as possible. The Coast Guard would not expect to continue to reconsider an LOR after the jurisdictional agency has reached its decision, even if the process described above has not run its course. As stated above, the LOR is intended to inform the jurisdictional agency's decision, and a reconsideration resulting in revisions to the LOR after the jurisdictional agency's decision would not serve the purpose of the LOR. We strongly recommend that any requests for reconsideration be submitted as soon as possible after the LOR is issued, to allow adequate time for Coast Guard reconsideration and for the jurisdictional agency's consideration of any revised LOR.

We developed this proposed 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.

Executive Orders 12866 (“Regulatory Planning and Review”) and 13563 (“Improving Regulation and Regulatory Review”) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This NPRM has not been designated a “significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB). A draft regulatory assessment follows:

This proposed rule would clarify the role and purpose of the LORs issued by the Coast Guard COTP regarding the suitability of a waterway for LNG or LHG marine traffic. It would also provide a separate process for LOR reconsideration for facility owners or operators and State or local government in the vicinity of the facility. If an LNG/LHG owner or operator or State or local government were to seek reconsideration of an LOR, a written request would be sent to the COTP who issued the LOR, and a copy would be sent to the jurisdictional agency. The proposed process, if finalized, would apply only to LORs issued after the effective date of the rule.

We do not expect this proposed rule to impose new regulatory costs on the LNG/LHG industry because an LNG/LHG facility owner or operator and State or local government in the vicinity of the facility will only request reconsideration if it does not agree with the recommendation. The option to request reconsideration of an LOR has been an industry practice for several years. Since 2007, there has been an average of about three requests for reconsiderations annually. As previously discussed, this proposed rule would replace the existing process for reconsideration with the process in proposed § 127.010, and would apply to new LORs issued after the effective date of the rule, not LORs already issued. As such, no change in either the frequency of request or burden is projected as a result of this rulemaking. Although market conditions may change in the future, the Coast Guard does not have any data to indicate the receipt of new requests for reconsideration of LORs within the foreseeable future.

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

Large corporations own the existing waterfront LNG facilities, and we expect this type of ownership to continue in the future. This type of ownership also exists for the approximately 159 LHG facilities operating in the United States. In addition, as stated above, the Coast Guard does not expect a change in either the frequency of request or burden as a result of this rulemaking. Therefore, we certify under 5 U.S.C. 605(b) that this proposed rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity, and that this rule would have a significant economic impact on it, please submit a comment to the Docket Management Facility at the address under ADDRESSES . In your comment, explain why you think it qualifies and how and to what degree this rule would economically affect it.

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 proposed rule so that the entities can better evaluate its effects on them and participate in the rulemaking process. If the proposed rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please consult with the Coast Guard personnel listed in the FOR FURTHER INFORMATION CONTACT section of this proposed rule. We will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (PRA). Under OMB regulations implementing the PRA, “Controlling Paperwork Burdens on the Public” (5 CFR 1320), collection of information means the obtaining, soliciting, or requiring the disclosure to an agency of information by or for an agency by means of identical questions posed to, or identical reporting, recordkeeping, or disclosure requirements imposed on, ten or more persons. “Ten or more persons” refers to the number of respondents to whom a collection of information is addressed by the agency within any 12-month period and does not include employees of the respondent acting within the scope of their employment, contractors engaged by a respondent for the purpose of complying with the collection of information, or current employees of the Federal government. Collections of information affecting ten or more respondents within any 12-month period require OMB review and approval.

This proposed rule articulates a separate process for reconsideration of LORs by the Coast Guard. As stated in Section V.A, there has been an average of about three requests for reconsideration annually since 2007, and the Coast Guard does not have any data to indicate the receipt of new requests for reconsideration of LORs within the foreseeable future. We therefore expect to receive fewer than ten requests per year. This figure is less than the threshold of ten respondents per 12-month period for collection of information reporting purposes under the PRA.

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

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

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

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

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

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

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

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

We have analyzed this proposed 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 made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. A preliminary environmental analysis checklist supporting this determination is available in the docket where indicated under the “Public Participation and Request for Comments” section of this preamble. This rule involves creating a separate process for reconsideration of LORs and falls under section 2.B.2, figure 2-1, paragraph (34)(a) of the Instruction, which includes regulations which are editorial or procedural, such as those updating addresses or establishing application procedures. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 127 as follows:

For additional information see the direct final rule which is published in the Rules section of this Federal Register . A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period on this document. Any parties interested in commenting on this document should do so at this time.

EPA is proposing a limited approval of Kentucky's June 25, 2008, and May 28, 2010, SIP revisions addressing regional haze under CAA sections 301(a) and 110(k)(3) because the revisions as a whole strengthen the Kentucky SIP. However, the Kentucky SIP relies on CAIR, an EPA rule, to satisfy key elements of the regional haze requirements. Due to the remand of CAIR, see North Carolina v. EPA, 531 F.3d 836 (DC Cir. 2008), the revisions do not meet all of the applicable requirements of the CAA and EPA's regulations as set forth in sections 169A and 169B of the CAA and in 40 CFR 51.300-308. As a result, EPA is concurrently proposing a limited disapproval of Kentucky's SIP revisions. The revisions nevertheless represent an improvement over the current SIP, and make considerable progress in fulfilling the applicable CAA regional haze program requirements. This proposed rulemaking and the accompanying Technical Support Document 1 (TSD) explain the basis for EPA's proposed limited approval and limited disapproval actions.

Under CAA sections 301(a) and 110(k)(6) and EPA's long-standing guidance, a limited approval results in approval of the entire SIP submittal, even of those parts that are deficient and prevent EPA from granting a full approval of the SIP revision. Processing of State Implementation Plan (SIP) Revisions, EPA Memorandum from John Calcagni, Director, Air Quality Management Division, OAQPS, to Air Division Directors, EPA Regional Offices I-X, September 7, 1992, (1992 Calcagni Memorandum) located at http://www.epa.gov/ttn/caaa/t1/memoranda/siproc.pdf. The deficiencies that EPA has identified as preventing a full approval of this SIP revision relate to the status and impact of CAIR on certain interrelated and required elements of the regional haze program. At the time the Kentucky regional haze SIP was being developed, the Commonwealth's reliance on CAIR was fully consistent with EPA's regulations, see 70 FR 39104, 39142 (July 6, 2005). CAIR, as originally promulgated, requires significant reductions in emissions of sulfur dioxide (SO 2 ) and nitrogen oxides (NO X ) to limit the interstate transport of these pollutants, and the reliance on CAIR by affected states as an alternative to requiring BART for electric generating units (EGUs) had specifically been upheld in Utility Air Regulatory Group v. EPA, 471 F.3d 1333 (DC Cir. 2006). In 2008, however, the DC Circuit remanded CAIR back to EPA. See North Carolina v. EPA, 550 F.3d 1176 (DC Cir. 2008). The Court found CAIR to be inconsistent with the requirements of the CAA, see North Carolina v. EPA, 531 F.3d 896 (DC Cir. 2008), but ultimately remanded the rule to EPA without vacatur because it found that “allowing CAIR to remain in effect until it is replaced by a rule consistent with [the court's] opinion would at least temporarily preserve the environmental values covered by CAIR.” North Carolina v. EPA, 550 F.3d at 1178. In response to the court's decision, EPA has issued a new rule to address interstate transport of NO X and SO 2 in the eastern United States (i.e., the Transport Rule, also known as the Cross-State Air Pollution Rule). See 76 FR 48208 (August 8, 2011). EPA explained in that action that EPA is promulgating the Transport Rule as a replacement for (not a successor to) CAIR's SO 2 and NO X emissions reduction and trading programs. In other words, the CAIR and CAIR Federal Implementation Plan (FIP) requirements only remain in force to address emissions through the 2011 control periods. As part of the Transport Rule, EPA finalized regulatory changes to sunset the CAIR and CAIR FIPs for control periods in 2012 and beyond. See 76 FR 48322.

EPA also stated in that final action that EPA has not conducted a technical analysis to determine whether compliance with the Transport Rule would satisfy the requirements of the RHR addressing alternatives to BART. For that reason, EPA did not make a determination or establish a presumption that compliance with the Transport Rule satisfies BART-related requirements for EGUs. EPA is now in the process of determining whether compliance with the Transport Rule will provide for greater reasonable progress toward improving visibility than source-specific BART controls for EGUs but no such determination has yet been proposed.

Regional haze is visibility impairment that is produced by a multitude of sources and activities which are located across a broad geographic area and emit fine particles (PM 2.5 ) (e.g., sulfates, nitrates, organic carbon, elemental carbon, and soil dust), and their precursors (e.g., SO 2 , NO X , and in some cases, ammonia (NH 3 ) and volatile organic compounds (VOC)). Fine particle precursors react in the atmosphere to form fine particulate matter which impairs visibility by scattering and absorbing light. Visibility impairment reduces the clarity, color, and visible distance that one can see. PM 2.5 can also cause serious health effects and mortality in humans and contributes to environmental effects such as acid deposition and eutrophication.

Data from the existing visibility monitoring network, the “Interagency Monitoring of Protected Visual Environments” (IMPROVE) monitoring network, show that visibility impairment caused by air pollution occurs virtually all the time at most national park and wilderness areas. The average visual range  2 in many Class I areas  3 (i.e., national parks and memorial parks, wilderness areas, and international parks meeting certain size criteria) in the western United States is 100-150 kilometers, or about one-half to two-thirds of the visual range that would exist without anthropogenic air pollution. In most of the eastern Class I areas of the United States, the average visual range is less than 30 kilometers, or about one-fifth of the visual range that would exist under estimated natural conditions. See 64 FR 35715 (July 1, 1999).

In section 169A of the 1977 Amendments to the CAA, Congress created a program for protecting visibility in the nation's national parks and wilderness areas. This section of the CAA establishes as a national goal the “prevention of any future, and the remedying of any existing, impairment of visibility in mandatory Class I Federal areas which impairment results from manmade air pollution.” On December 2, 1980, EPA promulgated regulations to address visibility impairment in Class I areas that is “reasonably attributable” to a single source or small group of sources, i.e., “reasonably attributable visibility impairment.” See 45 FR 80084. These regulations represented the first phase in addressing visibility impairment. EPA deferred action on regional haze that emanates from a variety of sources until monitoring, modeling, and scientific knowledge about the relationships between pollutants and visibility impairment were improved.

Congress added section 169B to the CAA in 1990 to address regional haze issues. EPA promulgated a rule to address regional haze on July 1, 1999 (64 FR 35713), the RHR. The RHR revised the existing visibility regulations to integrate into the regulation provisions addressing regional haze impairment and established a comprehensive visibility protection program for Class I areas. The requirements for regional haze, found at 40 CFR 51.308 and 51.309, are included in EPA's visibility protection regulations at 40 CFR 51.300-309. Some of the main elements of the regional haze requirements are summarized in section III of this preamble. The requirement to submit a regional haze SIP applies to all 50 states, the District of Columbia, and the Virgin Islands. 4 40 CFR 51.308(b) requires states to submit the first implementation plan addressing regional haze visibility impairment no later than December 17, 2007.

Successful implementation of the regional haze program will require long-term regional coordination among states, tribal governments, and various Federal agencies. As noted above, pollution affecting the air quality in Class I areas can be transported over long distances, even hundreds of kilometers. Therefore, to effectively address the problem of visibility impairment in Class I areas, states need to develop strategies in coordination with one another, taking into account the effect of emissions from one jurisdiction on the air quality in another.

Because the pollutants that lead to regional haze can originate from sources located across broad geographic areas, EPA has encouraged the states and tribes across the United States to address visibility impairment from a regional perspective. Five regional planning organizations (RPOs) were developed to address regional haze and related issues. The RPOs first evaluated technical information to better understand how their states and tribes impact Class I areas across the country, and then pursued the development of regional strategies to reduce emissions of particulate matter (PM) and other pollutants leading to regional haze.

The Visibility Improvement State and Tribal Association of the Southeast (VISTAS) RPO is a collaborative effort of state governments, tribal governments, and various Federal agencies established to initiate and coordinate activities associated with the management of regional haze, visibility and other air quality issues in the southeastern United States. Member state and tribal governments include: Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee, Virginia, West Virginia, and the Eastern Band of the Cherokee Indians.

Regional haze SIPs must assure reasonable progress towards the national goal of achieving natural visibility conditions in Class I areas. Section 169A of the CAA and EPA's implementing regulations require states to establish long-term strategies for making reasonable progress toward meeting this goal. Implementation plans must also give specific attention to certain stationary sources that were in existence on August 7, 1977, but were not in operation before August 7, 1962, and require these sources, where appropriate, to install BART controls for the purpose of eliminating or reducing visibility impairment. The specific regional haze SIP requirements are discussed in further detail below.

The RHR establishes the deciview as the principal metric or unit for expressing visibility. This visibility metric expresses uniform changes in haziness in terms of common increments across the entire range of visibility conditions, from pristine to extremely hazy conditions. Visibility expressed in deciviews is determined by using air quality measurements to estimate light extinction and then transforming the value of light extinction using a logarithm function. The deciview is a more useful measure for tracking progress in improving visibility than light extinction itself because each deciview change is an equal incremental change in visibility perceived by the human eye. Most people can detect a change in visibility at one deciview. 5

The deciview is used in expressing RPGs (which are interim visibility goals towards meeting the national visibility goal), defining baseline, current, and natural conditions, and tracking changes in visibility. The regional haze SIPs must contain measures that ensure “reasonable progress” toward the national goal of preventing and remedying visibility impairment in Class I areas caused by anthropogenic air pollution by reducing anthropogenic emissions that cause regional haze. The national goal is a return to natural conditions, i.e., anthropogenic sources of air pollution would no longer impair visibility in Class I areas.

To track changes in visibility over time at each of the 156 Class I areas covered by the visibility program (40 CFR 81.401-437), and as part of the process for determining reasonable progress, states must calculate the degree of existing visibility impairment at each Class I area at the time of each regional haze SIP submittal and periodically review progress every five years, i.e., midway through each 10-year implementation period. To do this, the RHR requires states to determine the degree of impairment (in deciviews) for the average of the 20 percent least impaired (“best”) and 20 percent most impaired (“worst”) visibility days over a specified time period at each of their Class I areas. In addition, states must also develop an estimate of natural visibility conditions for the purpose of comparing progress toward the national goal. Natural visibility is determined by estimating the natural concentrations of pollutants that cause visibility impairment and then calculating total light extinction based on those estimates. EPA has provided guidance to states regarding how to calculate baseline, natural, and current visibility conditions in documents titled, EPA's Guidance for Estimating Natural Visibility Conditions Under the Regional Haze Rule, September 2003, (EPA-454/B-03-005 located at http://www.epa.gov/ttncaaa1/t1/memoranda/rh_envcurhr_gd.pdf ) (hereinafter referred to as “EPA's 2003 Natural Visibility Guidance”), and Guidance for Tracking Progress Under the Regional Haze Rule, September 2003, (EPA-454/B-03-004 located at http://www.epa.gov/ttncaaa1/t1/memoranda/rh_tpurhr_gd.pdf ) (hereinafter referred to as “EPA's 2003 Tracking Progress Guidance”).

For the first regional haze SIPs that were due by December 17, 2007, “baseline visibility conditions” were the starting points for assessing “current” visibility impairment. Baseline visibility conditions represent the degree of visibility impairment for the 20 percent least impaired days and 20 percent most impaired days for each calendar year from 2000 to 2004. Using monitoring data for 2000 through 2004, states are required to calculate the average degree of visibility impairment for each Class I area, based on the average of annual values over the five-year period. The comparison of initial baseline visibility conditions to natural visibility conditions indicates the amount of improvement necessary to attain natural visibility, while the future comparison of baseline conditions to the then current conditions will indicate the amount of progress made. In general, the 2000-2004 baseline period is considered the time from which improvement in visibility is measured.

The vehicle for ensuring continuing progress towards achieving the natural visibility goal is the submission of a series of regional haze SIPs from the states that establish two RPGs (i.e., two distinct goals, one for the “best” and one for the “worst” days) for every Class I area for each (approximately) 10-year implementation period. The RHR does not mandate specific milestones or rates of progress, but instead calls for states to establish goals that provide for “reasonable progress” toward achieving natural (i.e., “background”) visibility conditions. In setting RPGs, states must provide for an improvement in visibility for the most impaired days over the (approximately) 10-year period of the SIP, and ensure no degradation in visibility for the least impaired days over the same period.

States have significant discretion in establishing RPGs, but are required to consider the following factors established in section 169A of the CAA and in EPA's RHR at 40 CFR 51.308(d)(1)(i)(A): (1) The costs of compliance; (2) the time necessary for compliance; (3) the energy and non-air quality environmental impacts of compliance; and (4) the remaining useful life of any potentially affected sources. States must demonstrate in their SIPs how these factors are considered when selecting the RPGs for the best and worst days for each applicable Class I area. States have considerable flexibility in how they take these factors into consideration, as noted in EPA's Guidance for Setting Reasonable Progress Goals under the Regional Haze Program (“EPA's Reasonable Progress Guidance”), July 1, 2007, memorandum from William L. Wehrum, Acting Assistant Administrator for Air and Radiation, to EPA Regional Administrators, EPA Regions 1-10 (pp. 4-2, 5-1). In setting the RPGs, states must also consider the rate of progress needed to reach natural visibility conditions by 2064 (referred to as the “uniform rate of progress” or the “glidepath”) and the emission reduction measures needed to achieve that rate of progress over the 10-year period of the SIP. Uniform progress towards achievement of natural conditions by the year 2064 represents a rate of progress which states are to use for analytical comparison to the amount of progress they expect to achieve. In setting RPGs, each state with one or more Class I areas (“Class I state”) must also consult with potentially “contributing states,” i.e., other nearby states with emission sources that may be affecting visibility impairment at the Class I state's areas. See 40 CFR 51.308(d)(1)(iv).

Section 169A of the CAA directs states to evaluate the use of retrofit controls at certain larger, often uncontrolled, older stationary sources in order to address visibility impacts from these sources. Specifically, section 169A(b)(2)(A) of the CAA requires states to revise their SIPs to contain such measures as may be necessary to make reasonable progress towards the natural visibility goal, including a requirement that certain categories of existing major stationary sources  6 built between 1962 and 1977 procure, install, and operate the “Best Available Retrofit Technology” as determined by the state. Under the RHR, states are directed to conduct BART determinations for such “BART-eligible” sources that may be anticipated to cause or contribute to any visibility impairment in a Class I area. Rather than requiring source-specific BART controls, states also have the flexibility to adopt an emissions trading program or other alternative program as long as the alternative provides greater reasonable progress towards improving visibility than BART.

On July 6, 2005, EPA published the Guidelines for BART Determinations Under the Regional Haze Rule at Appendix Y to 40 CFR Part 51 (hereinafter referred to as the “BART Guidelines”) to assist states in determining which of their sources should be subject to the BART requirements and in determining appropriate emission limits for each applicable source. In making a BART determination for a fossil fuel-fired electric generating plant with a total generating capacity in excess of 750 megawatts (MW), a state must use the approach set forth in the BART Guidelines. A state is encouraged, but not required, to follow the BART Guidelines in making BART determinations for other types of sources.

States must address all visibility-impairing pollutants emitted by a source in the BART determination process. The most significant visibility impairing pollutants are SO 2 , NO X , and PM. EPA has stated that states should use their best judgment in determining whether VOC or NH 3 compounds impair visibility in Class I areas.

Under the BART Guidelines, states may select an exemption threshold value for their BART modeling, below which a BART-eligible source would not be expected to cause or contribute to visibility impairment in any Class I area. The state must document this exemption threshold value in the SIP and must state the basis for its selection of that value. Any source with emissions that model above the threshold value would be subject to a BART determination review. The BART Guidelines acknowledge varying circumstances affecting different Class I areas. States should consider the number of emission sources affecting the Class I areas at issue and the magnitude of the individual sources' impacts. Any exemption threshold set by the state should not be higher than 0.5 deciview.

In their SIPs, states must identify potential BART sources, described as “BART-eligible sources” in the RHR, and document their BART control determination analyses. In making BART determinations, section 169A(g)(2) of the CAA requires that states consider the following factors: (1) The costs of compliance, (2) the energy and non-air quality environmental impacts of compliance, (3) any existing pollution control technology in use at the source, (4) the remaining useful life of the source, and (5) the degree of improvement in visibility which may reasonably be anticipated to result from the use of such technology. States are free to determine the weight and significance to be assigned to each factor.

A regional haze SIP must include source-specific BART emission limits and compliance schedules for each source subject to BART. Once a state has made its BART determination, the BART controls must be installed and in operation as expeditiously as practicable, but no later than five years after the date of EPA approval of the regional haze SIP. See CAA section 169(g)(4); see 40 CFR 51.308(e)(1)(iv). In addition to what is required by the RHR, general SIP requirements mandate that the SIP must also include all regulatory requirements related to monitoring, recordkeeping, and reporting for the BART controls on the source.

As noted above, the RHR allows states to implement an alternative program in lieu of BART so long as the alternative program can be demonstrated to achieve greater reasonable progress toward the national visibility goal than would BART. Under regulations issued in 2005 revising the regional haze program, EPA made just such a demonstration for CAIR. See 70 FR 39104 (July 6, 2005). EPA's regulations provide that states participating in the CAIR cap-and trade program under 40 CFR part 96 pursuant to an EPA-approved CAIR SIP or which remain subject to the CAIR FIP in 40 CFR part 97 need not require affected BART-eligible EGUs to install, operate, and maintain BART for emissions of SO 2 and NO X . See 40 CFR 51.308(e)(4). Because CAIR did not address direct emissions of PM, states were still required to conduct a BART analysis for PM emissions from EGUs subject to BART for that pollutant.

Consistent with the requirement in section 169A(b) of the CAA that states include in their regional haze SIP a 10 to 15 year strategy for making reasonable progress, section 51.308(d)(3) of the RHR requires that states include a LTS in their regional haze SIPs. The LTS is the compilation of all control measures a state will use during the implementation period of the specific SIP submittal to meet applicable RPGs. The LTS must include “enforceable emissions limitations, compliance schedules, and other measures as necessary to achieve the reasonable progress goals” for all Class I areas within, or affected by emissions from, the state. See 40 CFR 51.308(d)(3).

When a state's emissions are reasonably anticipated to cause or contribute to visibility impairment in a Class I area located in another state, the RHR requires the impacted state to coordinate with the contributing states in order to develop coordinated emissions management strategies. See 40 CFR 51.308(d)(3)(i). In such cases, the contributing state must demonstrate that it has included, in its SIP, all measures necessary to obtain its share of the emissions reductions needed to meet the RPGs for the Class I area. The RPOs have provided forums for significant interstate consultation, but additional consultations between states may be required to sufficiently address interstate visibility issues. This is especially true where two states belong to different RPOs.

States should consider all types of anthropogenic sources of visibility impairment in developing their LTS, including stationary, minor, mobile, and area sources. At a minimum, states must describe how each of the following seven factors listed below are taken into account in developing their LTS: (1) Emissions reductions due to ongoing air pollution control programs, including measures to address RAVI; (2) measures to mitigate the impacts of construction activities; (3) emissions limitations and schedules for compliance to achieve the RPG; (4) source retirement and replacement schedules; (5) smoke management techniques for agricultural and forestry management purposes including plans as currently exist within the state for these purposes; (6) enforceability of emissions limitations and control measures; and (7) the anticipated net effect on visibility due to projected changes in point, area, and mobile source emissions over the period addressed by the LTS. See 40 CFR 51.308(d)(3)(v).

As part of the RHR, EPA revised 40 CFR 51.306(c) regarding the LTS for RAVI to require that the RAVI plan must provide for a periodic review and SIP revision not less frequently than every three years until the date of submission of the state's first plan addressing regional haze visibility impairment, which was due December 17, 2007, in accordance with 40 CFR 51.308(b) and (c). On or before this date, the state must revise its plan to provide for review and revision of a coordinated LTS for addressing RAVI and regional haze, and the state must submit the first such coordinated LTS with its first regional haze SIP. Future coordinated LTS's, and periodic progress reports evaluating progress towards RPGs, must be submitted consistent with the schedule for SIP submission and periodic progress reports set forth in 40 CFR 51.308(f) and 51.308(g), respectively. The periodic review of a state's LTS must report on both regional haze and RAVI impairment and must be submitted to EPA as a SIP revision.

Section 51.308(d)(4) of the RHR includes the requirement for a monitoring strategy for measuring, characterizing, and reporting of regional haze visibility impairment that is representative of all mandatory Class I Federal areas within the state. The strategy must be coordinated with the monitoring strategy required in section 51.305 for RAVI. Compliance with this requirement may be met through “participation” in the IMPROVE network, i.e., review and use of monitoring data from the network. The monitoring strategy is due with the first regional haze SIP, and it must be reviewed every five years. The monitoring strategy must also provide for additional monitoring sites if the IMPROVE network is not sufficient to determine whether RPGs will be met.

The SIP must also provide for the following:

• Procedures for using monitoring data and other information in a state with mandatory Class I areas to determine the contribution of emissions from within the state to regional haze visibility impairment at Class I areas both within and outside the state;

• Procedures for using monitoring data and other information in a state with no mandatory Class I areas to determine the contribution of emissions from within the state to regional haze visibility impairment at Class I areas in other states;

• Reporting of all visibility monitoring data to the Administrator at least annually for each Class I area in the state, and where possible, in electronic format;

• Developing a statewide inventory of emissions of pollutants that are reasonably anticipated to cause or contribute to visibility impairment in any Class I area. The inventory must include emissions for a baseline year, emissions for the most recent year for which data are available, and estimates of future projected emissions. A state must also make a commitment to update the inventory periodically; and

• Other elements, including reporting, recordkeeping, and other measures necessary to assess and report on visibility.

The RHR requires control strategies to cover an initial implementation period extending to the year 2018, with a comprehensive reassessment and revision of those strategies, as appropriate, every 10 years thereafter. Periodic SIP revisions must meet the core requirements of section 51.308(d) with the exception of BART. The requirement to evaluate sources for BART applies only to the first regional haze SIP. Facilities subject to BART must continue to comply with the BART provisions of section 51.308(e), as noted above. Periodic SIP revisions will assure that the statutory requirement of reasonable progress will continue to be met.

The RHR requires that states consult with FLMs before adopting and submitting their SIPs. See 40 CFR 51.308(i). States must provide FLMs an opportunity for consultation, in person and at least 60 days prior to holding any public hearing on the SIP. This consultation must include the opportunity for the FLMs to discuss their assessment of impairment of visibility in any Class I area and to offer recommendations on the development of the RPGs and on the development and implementation of strategies to address visibility impairment. Further, a state must include in its SIP a description of how it addressed any comments provided by the FLMs. Finally, a SIP must provide procedures for continuing consultation between the state and FLMs regarding the state's visibility protection program, including development and review of SIP revisions, five-year progress reports, and the implementation of other programs having the potential to contribute to impairment of visibility in Class I areas.

CAIR, as originally promulgated, required 28 states and the District of Columbia to reduce emissions of SO 2 and NO X that significantly contributed to, or interfered with maintenance of, the 1997 national ambient air quality standards (NAAQS) for fine particulates and/or the 1997 NAAQS for 8-hour ozone in any downwind state. See 70 FR 25162 (May 12, 2005). CAIR established emissions budgets for SO 2 and NO X for states found to contribute significantly to nonattainment in downwind states and required these states to submit SIP revisions that implemented these budgets. States had the flexibility to choose which control measures to adopt to achieve the budgets, including participation in EPA-administered cap-and-trade programs addressing SO 2, NO X -annual, and NO X -ozone season emissions. In 2006, EPA promulgated FIPs for all states covered by CAIR to ensure the reductions were achieved in a timely manner.

On July 11, 2008, the D.C. Circuit issued its decision to vacate and remand both CAIR and the associated CAIR FIPs in their entirety. See North Carolina v. EPA, 531 F.3d 836 (D.C. Cir. 2008). However, in response to EPA's petition for rehearing, the Court issued an order remanding CAIR to EPA without vacating either CAIR or the CAIR FIPs. The Court thereby left the EPA CAIR rule and CAIR SIPs and FIPs in place in order to “temporarily preserve the environmental values covered by CAIR” until EPA replaces it with a rule consistent with the court's opinion. See North Carolina v. EPA, 550 F.3d at 1178. The Court directed EPA to “remedy CAIR's flaws” consistent with its July 11, 2008, opinion but declined to impose a schedule on EPA for completing that action. EPA subsequently promulgated the Transport Rule to replace CAIR. 76 FR 48208 (August 8, 2011).

The following is a summary of the elements of the regional haze SIPs that are potentially affected by the remand of CAIR. As described above, EPA determined in 2005 that states opting to participate in the CAIR cap-and-trade program need not require BART for SO 2 and NO X at BART-eligible EGUs. 70 FR at 39142-39143. Many states relied on CAIR as an alternative to BART for SO 2 and NO X for subject EGUs, as allowed under the BART provisions at 40 CFR 51.308(e)(4). Additionally, several states established RPGs that reflect the improvement in visibility expected to result from controls planned for or already installed on sources within the state to meet the CAIR provisions for this implementation period for specified pollutants. Many states relied upon their own CAIR SIPs or the CAIR FIPs for their states to provide the legal requirements which lead to these planned controls, and did not include enforceable measures in the LTS in the regional haze SIP submission to ensure these reductions. States also submitted demonstrations showing that no additional controls on EGUs beyond CAIR would be reasonable for this implementation period. Because of the deficiencies identified in CAIR by the court and the impact of the Transport Rule on CAIR, it is inappropriate to fully approve states' LTSs that rely upon the emissions reductions predicted to result from CAIR to meet the BART requirement for EGUs or to meet the RPGs in the states' regional haze SIPs. For this reason, EPA cannot fully approve regional haze SIP revisions that rely on CAIR for emission reduction measures. However, as discussed in section IV.D, EPA still believes it is appropriate to propose a limited approval of Kentucky's regional haze SIP revisions as these revisions provide an improvement over the current SIP, and make progress in fulfilling the applicable CAA regional haze program requirements. EPA therefore proposes to grant limited approval and limited disapproval of the two Kentucky regional haze SIP revisions. The next section discusses how the Agency proposes to address these deficiencies.

In the Transport Rule, EPA did not substantively address the question of whether the emissions reductions from the Transport Rule will provide for greater reasonable progress than BART. EPA explained in that rulemaking that the Agency had not yet conducted any technical analysis to determine whether compliance with the Transport Rule would satisfy the requirements for a BART alternative program. Given the lack of any analysis at that time, EPA made no determinations as to whether the Transport Rule would provide sufficient emissions reductions and concomitant improvements in visibility to be considered to provide for greater reasonable progress than BART. Although EPA is now in the process of undertaking such an analysis, no action has been proposed. As a result, today's proposal action on Kentucky's regional haze SIP is affected by the issuance of the Transport Rule only insofar as the Transport Rule provides for the sunsetting of CAIR. Future analyses involving the Transport Rule and BART will determine appropriate subsequent Agency action on Kentucky's regional haze SIP revisions.

EPA is intending to propose to issue limited approvals of those regional haze SIP revisions that rely on CAIR to address the impact of emissions from a state's own EGUs. Limited approval results in approval of the entire regional haze submission and all its elements. EPA is taking this approach because an affected state's SIP will be stronger and more protective of the environment with the implementation of those measures by the state and having Federal approval and enforceability than it would without those measures being included in the state's SIP.

EPA also intends to propose to issue limited disapprovals for regional haze SIP revisions that rely on CAIR. As explained in the 1992 Calcagni Memorandum, “[t]hrough a limited approval, EPA [will] concurrently, or within a reasonable period of time thereafter, disapprove the rule * * * for not meeting all of the applicable requirements of the Act. * * * [T]he limited disapproval is a rulemaking action, and it is subject to notice and comment.” Final limited disapproval of a SIP submittal does not affect the Federal enforceability of the measures in the subject SIP revision nor prevent state implementation of these measures. The legal effects of the final limited disapproval are to provide EPA the authority to issue a FIP at any time, and to obligate the Agency to take such action no more than two years after the effective date of the final limited disapproval action.

On June 25, 2008, and May 28, 2010, KYDAQ submitted revisions to the Kentucky SIP to address regional haze in the Commonwealth's Class I area as required by EPA's RHR. Throughout this document, references to Kentucky's (or KYDAQ's or the Commonwealth's) “regional haze SIP” refer to Kentucky's original June 25, 2008, regional haze SIP submittal, as later amended in a SIP revision submitted May 28, 2010.

Kentucky has one Class I area within its borders: Mammoth Cave National Park. Kentucky is responsible for developing a regional haze SIP that addresses this Class I area and for consulting with other states that impact the area.

The June 25, 2008, Kentucky regional haze SIP, as later amended on May 28, 2010, establishes RPGs for visibility improvement at Mammoth Cave National Park and a LTS to achieve those RPGs within the first regional haze implementation period ending in 2018. In developing the LTS for the area, Kentucky considered both emission sources inside and outside of Kentucky that may cause or contribute to visibility impairment in Kentucky's Class I area. The Commonwealth also identified and considered emission sources within Kentucky that may cause or contribute to visibility impairment in Class I areas in neighboring states as required by 40 CFR 51.308(d)(3). The VISTAS RPO worked with the Commonwealth in developing the technical analyses used to make these determinations, including state-by-state contributions to visibility impairment in specific Class I areas, which included the Class I area in Kentucky and those areas affected by emissions from Kentucky.

As required by the RHR and in accordance with EPA's 2003 Natural Visibility Guidance, Kentucky calculated baseline/current and natural visibility conditions for its Class I area, as summarized below (and as further described in sections III.B.1 and III.B.2 of EPA's TSD to this Federal Register action).

Natural background visibility, as defined in EPA's 2003 Natural Visibility Guidance, is estimated by calculating the expected light extinction using default estimates of natural concentrations of fine particle components adjusted by site-specific estimates of humidity. This calculation uses the IMPROVE equation, which is a formula for estimating light extinction from the estimated natural concentrations of fine particle components (or from components measured by the IMPROVE monitors). As documented in EPA's 2003 Natural Visibility Guidance, EPA allows states to use “refined” or alternative approaches to 2003 EPA guidance to estimate the values that characterize the natural visibility conditions of the Class I areas. One alternative approach is to develop and justify the use of alternative estimates of natural concentrations of fine particle components. Another alternative is to use the “new IMPROVE equation” that was adopted for use by the IMPROVE Steering Committee in December 2005. 7 The purpose of this refinement to the “old IMPROVE equation” is to provide more accurate estimates of the various factors that affect the calculation of light extinction. Kentucky opted to use this refined approach, referred to as the “new IMPROVE equation,” for its Class I area.

Natural visibility conditions using the new IMPROVE equation were calculated separately for each Class I area by VISTAS. Natural background visibility, as defined in EPA's 2003 Natural Visibility Guidance, is estimated by calculating the expected light extinction using default estimates of natural concentrations of fine particle components adjusted by site-specific estimates of humidity.

The new IMPROVE equation takes into account the most recent review of the science  8 and it accounts for the effect of particle size distribution on light extinction efficiency of sulfate, nitrate, and organic carbon. It also adjusts the mass multiplier for organic carbon (particulate organic matter) by increasing it from 1.4 to 1.8. New terms are added to the equation to account for light extinction by sea salt and light absorption by gaseous nitrogen dioxide. Site-specific values are used for Rayleigh scattering (scattering of light due to atmospheric gases) to account for the site-specific effects of elevation and temperature. Separate relative humidity enhancement factors are used for small and large size distributions of ammonium sulfate and ammonium nitrate and for sea salt. The terms for the remaining contributors, elemental carbon (light-absorbing carbon), fine soil, and coarse mass terms, do not change between the original and new IMPROVE equations.

KYDAQ estimated baseline visibility conditions at the Kentucky Class I area using available monitoring data from an IMPROVE monitoring site in Mammoth Cave National Park. As explained in section III.B, baseline visibility conditions are the same as current conditions for the first regional haze SIP. A five-year average of the 2000 to 2004 monitoring data was calculated for each of the 20 percent worst and 20 percent best visibility days at the Kentucky Class I area. IMPROVE data records for Mammoth Cave National Park for the period 2000 to 2004 meet the EPA requirements for data completeness. See page 2-8 of EPA's 2003 Tracking Progress Guidance. Table 3.3-1 from Appendix G of the Kentucky regional haze SIP, also provided in section III.B.3 of EPA's TSD to this action, lists the 20 percent best and worst days for the baseline period of 2000-2004 for Mammoth Cave National Park. This data is also provided at the following Web site: http://www.metro4-sesarm.org/vistas/SesarmBext_20BW.htm.

For the Kentucky Class I area, baseline visibility on the 20 percent worst days is approximately 31 deciviews. Natural visibility in the area is predicted to be approximately 11 deciviews on the 20 percent worst days. The natural and baseline conditions for Kentucky's Class I area for both the 20 percent worst and best days are presented in Table 1 below.

On October 3, 2011, the Centers for Disease Control (CDC), located within the Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking (NPRM) in the Federal Register (76 FR 61206) requesting public comment on (1) The appropriateness of the current HHS and Overlap list of select agents and toxins including whether there are other agents or toxins that should be added to the HHS or Overlap list or whether agents or toxins currently on the HHS or Overlap list should be deleted from the list; (2) the appropriateness of the proposed tiering of the select agents and toxins list; (3) whether minimum standards for personnel reliability, physical and cyber security should be prescribed for identified Tier 1 agents; and (4) any other aspect of the proposed amendments to the select agent regulations. The comment period closed on December 2, 2011. Since we would like to allow interested persons additional time to prepare and submit comments, we are reopening the comment period for its NPRM. We will also consider all comments we receive between December 2, 2011 and the date of this notice.

The transplant community has performed transplants of hands and various body parts using the term composite tissue allograft; however, for the purposes of rulemaking, the Health Resources and Services Administration (HRSA) has defined a subset of such body parts as vascularized composite allografts (VCA), which share certain characteristics.

Based upon a review of VCA, the Secretary believes that VCA should now be included within the definition of organs covered by the rules governing the operation of the Organ Procurement and Transplantation Network (OPTN) (hereinafter the OPTN final rule) (42 CFR part 121). This notice sets forth the history of VCA transplants, the factors that have persuaded the Department of the advisability of including VCA within the authority of the regulations governing the operation of the OPTN, the Secretary's oversight of VCA, and the anticipated consequences of this proposal. The notice also discusses the Department's proposal to include VCA within the definition of human organs covered by section 301 of the National Organ Transplant Act of 1984, as amended (hereinafter section 301 of NOTA).

Through this notice, the Secretary seeks comments from the public on the proposals made. Additional information on the submission of comments and/or the rulemaking process can be obtained from the Director, Division of Policy Review and Coordination, Health Resources and Services Administration, 5600 Fishers Lane, Room 14A-11, Rockville, Maryland 20857.

VCA transplantation comprises transplants of a variety of body parts (all of which contain similar characteristics, described later) that are not currently regulated under the OPTN final rule. Perhaps the two most notable types to date have been hand and face transplants. The first successful hand transplant in the United States was performed in 1999 and the first face transplant in the U.S. was performed in 2008. Worldwide, there have been over three dozen limb transplants, at least a dozen transplants of portions of the face, and a small number of transplants of other such anatomical parts ( e.g., abdominal wall, vascularized skeletal muscle, and digits). Accurate data about the actual number of such transplants have been difficult to obtain because there is no requirement for reporting these procedures in the U.S. Most of the available information has been obtained from published news accounts in the popular press and anecdotal reports in the medical literature.

Although the body parts involved vary significantly, among their shared characteristics is the fact that they are susceptible to ischemia (damage or death from lack of blood flow) and that they need revascularization, done through a surgical reconnection of blood vessels to accomplish the transplant, as opposed to secondary ingrowth of vessels. In viable vascularized transplants, immunosuppression is necessary to prevent or treat rejection. This immunosuppression has risks, which have been justified in patients needing organs as presently defined in the OPTN final rule because of their lifesaving potential. In the past, the risks of immunosuppression have inhibited transplantation of VCA because the risks associated with the prolonged use of immunosuppressive drugs were thought to exceed the expected benefits of the transplants. However, the powerful impact these transplants can have to improve the quality of life for individuals with grievous disabilities has become increasingly apparent. Immunosuppressive management for these transplants has also improved so that risks associated with immunosuppression, such as cancer, infection, or other morbidities in recipients, are lessened considerably. (F Schuind, Hand transplantation and vascularized composite tissue allografts in orthopaedics and traumatology, Orthopaedics & Traumatology: Surgery & Research (2010) 96, 283-290, and Armed Forces Institute of Regenerative Medicine Annual Report, 2009, pp II-1 and II-62 and II-63). In recent years, the Departments of Defense and Veterans Affairs have initiated substantial funding of clinical research programs for limb and face transplantation anticipating the reconstruction needs of wounded service members returning from the conflicts in Iraq and Afghanistan. More than 1,000 military men and women have lost an arm or leg in these conflicts and 20 percent have lost two or more limbs. As of mid-summer 2010, it was estimated that as many as 200 wounded troops might be eligible for face transplantation and about 50 for hand/forearm transplants. Most of the funding for limb and face transplantation research in the U.S. currently comes from the Departments of Defense and Veterans Affairs (Armed Forces Institute of Regenerative Medicine Annual Report, 2009, pp I-1 and I-2). For these reasons, it is likely that the numbers of VCA transplanted will increase in the future.

Human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient are regulated as a human cells, tissues, and cellular and tissue-based products or HCT/Ps. The Food and Drug Administration (FDA) regulates HCT/Ps under 21 CFR parts 1270 and 1271. Examples of such tissues are bone, skin, corneas, ligaments, tendons, dura mater, heart valves, hematopoietic stem/progenitor cells derived from peripheral and cord blood, oocytes, and semen. Face and hand allografts, and other body parts meeting the proposed definition of VCA in this notice are currently not explicitly excluded from the definition of HCT/Ps under FDA regulations and are therefore subject to FDA oversight. The FDA has no statutory or regulatory authority to mandate VCA allocation policies, direct coordination of procurement efforts, require consistent application of recovery and logistics processes, or establish mandatory outcomes reporting and provide oversight of VCA transplant programs. FDA does not regulate the transplantation of vascularized human organ transplants such as kidney, liver, heart, lung, or pancreas. The Health Resources Services Administration oversees the transplantation of vascularized human organs.

Given the anticipated increase in VCA transplants, HRSA published a Request for Information (RFI) on March 3, 2008, in the Federal Register for the purpose of soliciting feedback from stakeholders and the public as to whether VCA should be included within the definition of organs covered by the OPTN final rule and/or added to the definition of human organs covered by section 301 of NOTA. (73 FR 11420.) HRSA also sought feedback on the optimal way to define VCA if either definitional change was pursued.

Through the RFI, HRSA invited the public to attend a meeting on April 4, 2008 to discuss the issues described above. The meeting was well attended and provided a venue for discussion on VCA issues. Participants were instructed to provide written comments and the deadline for these comments to be received by HRSA was extended to July 2, 2008.

In response to its RFI, HRSA received 11 written comments about whether VCA should be included within the definition of organs covered by the OPTN final rule.

Eight of the written comments received supported including VCA within the definition of organs covered under the OPTN final rule. Many of these comments included similar supporting statements for OPTN oversight. The commenters agreed that the use of the existing solid organ transplant infrastructure would ensure rapid and equitable placement of VCA; allow allocation of VCA over a wide geographic area; facilitate identification of appropriate VCA donor and recipient pairs; provide assurance that all VCA programs are following similar rules, ensuring uniform and appropriate clinical and ethical standards on both the donation and transplantation side; facilitate the development of expertise and a body of knowledge that would be a valuable resource to address questions from the government or the public, and in the development of future policy and procedures in the field of VCA transplantation; enhance public transparency, increasing public acceptance of donation of VCA; and facilitate the protection of public health and safety in the context of VCA transplantation. Commenters also stated that the structure and goals of the OPTN are well aligned with the types of clinical and ethical concerns raised by VCA transplantation such as contingency treatment plan for complete face graft loss and fear of loss of facial identity due to transfer of donor facial characteristics (AJ Alexander et al , Arguing the Ethics of Facial Transplantation, Arch Facial Plast Surg. 2010;12(1):60-63) and with the types of entities that would be carrying out these activities, e.g., organ procurement organizations (OPOs) and transplant centers.

Of the three remaining comments, two supported partial inclusion of VCA within the OPTN final rule's definition of organs and the third comment did not support having VCA included within the OPTN final rule's definition of organs. Of the two comments advocating partial inclusion of VCA under the OPTN final rule's definition of organs, one stated that VCA should be classified as either “life extending” or “not life extending.” Life extending VCA were described as those involving: (a) Vascularized tissue, such as the use of abdominal wall transplanted to close a ruptured wound in a small bowel transplant recipient; and (b) non-vascularized tissue, such as a heart valve. Not life extending VCA were described as those involving: (c) vascularized tissue, such as a hand transplant; and (d) non-vascularized tissue, such as an anterior cruci, bone, or nerve grafts. The commenter supported including “life extending” VCA (a and b in the above examples) under the definition of organs under the OPTN final rule. According to this commenter, all life-saving VCA should follow the same rigorous testing and screening of donors and the procurement that is currently conducted by the OPTN contractor for organs currently covered under the OPTN final rule. However, the responder strongly opposed regulating “not life extending” VCA (c and d in the above examples), which are not conventional organ grafts, under the OPTN final rule. The responder suggested that although the OPTN should regulate control of distribution of the grafts, these two “not life extending” types (c and d) should be subject to less oversight. The commenter recommended new oversight legislation that would not hamper the innovation and utilization of these novel types of VCA. The Secretary wishes to make clear that certain of the body parts discussed by this commenter ( e.g., non-vascularized tissues, such as heart valves and anterior cruci, bone, or nerve grafts, regardless of whether they would be considered life-saving or life-enhancing) are regulated by the Food and Drug Administration (FDA) as HCT/Ps. (21 CFR part 1271).

The second comment supported limited oversight of VCA by the OPTN at this time. The commenter supported OPTN oversight with respect to designation of VCA transplant programs, data submission regarding transplant procedures, and donor screening. However, the commenter does not support allocation policies for VCA at this time due to the unknown clinical demand and overall future of these transplants. As noted above, clinical demand for VCA transplantation appears to be increasing now that immunosuppression protocols have proven safer and support for military and veterans VCA transplantation programs continues to expand. The issues concerning allocation, recipient safety, and outcomes reporting are similar for VCA and for organs currently under the OPTN's auspices. The VCA transplant community has clearly indicated its support for Federal oversight of VCA as organs through the OPTN in a letter of request from the Association of Organ Procurement Organizations to the Assistant Secretary of Health (December 9, 2010) and a publication of recommendations by the American Society of Transplant Surgeons in 2011 (Implementation of Vascularized Composite Allografts in the United States, American Journal of Transplantation (2011) 11:13-17),

The third comment did not support including VCA within the OPTN final rule's definition of organs. The comment stated that VCA do not fit as organs under HRSA oversight due to differences between solid organs procured for transplantation with the intent to save lives and VCA that are not used in life-saving applications. It also stated that the regulations that govern organ donation and transplantation are designed to maximize donation and to provide organs to as many waiting-list recipients as possible to avoid death due to their medical illness. According to the commenter, VCA recipients should not be subject to the same risks of donor transmissible diseases as recipients of traditional solid organs ( e.g., heart, lung, liver, and kidney). The commenter suggests that human-derived graft materials which enhance lives can be designated by Federal regulations under oversight of FDA as either an HCT/P, a biologic, or a medical device. However, both traditional organs and VCA originate from the same pool of potential donors and therefore subject all of these transplant recipients to similar risks of donor transmissible diseases. As described elsewhere, VCA share anatomic, clinical, allocation-logistical characteristics more closely related to those of traditional organs than biologics or medical devices. Therefore, in the Secretary's view, the appropriate way to distinguish those body parts that should be regulated as organs under the OPTN final rule and those that should not be similarly defined is based upon the properties of the body parts themselves rather than whether the intent is considered life-saving or life-enhancing. The OPTN final rule does allow some flexibility specific to each organ such that the OPTN may develop distinct organ-specific policies tailored to the circumstances, including risk of donor transmissible disease by transplanting particular organs.

The Secretary has considered comments that VCA such as hand transplants are not life saving and therefore are different from organs presently under HRSA and OPTN oversight. The Secretary does not agree with a direct demarcation between life-saving organ transplants and life-enhancing organ transplants for the purposes of defining organs under the OPTN final rule. The kidney has always been included in the list of organs governed by NOTA, the OPTN final rule, and the OPTN. Until additional life years provided by a kidney transplant (as opposed to continuing dialysis) were demonstrated, a kidney transplant was not understood to be life-saving. This fact did not dissuade the Congress from determining that kidneys should be subject to oversight under NOTA at its original enactment in 1984. As a result, kidney transplants are under the purview of the OPTN final rule and the OPTN (and subject to oversight by HRSA). Moreover, instead of adopting an all or nothing approach (life-extending versus life-enhancing), it may be better to understand improvements to the quality of life and increases to the length of life as coexisting on a spectrum of benefits. Hand and face transplants, and transplants of other body parts qualifying as VCA under the definition proposed here, may prove to be more powerful in improving a recipient's quality and extension of life than previously understood. In the Secretary's view, the appropriate way to distinguish between those VCA that should be regulated as organs under the OPTN final rule and body parts that should not be similarly defined is based upon the properties of the body parts themselves, rather than their potential impact upon the lives of their recipients.

Upon consideration of the comments received, and for the reasons described below, the Secretary now proposes that transplants of VCA be regulated under the OPTN final rule and governed by section 301 of NOTA.

Through this notice, the Department proposes adding VCA to the definition of organs included in the OPTN final rule, codified at 42 CFR 121.2, through rulemaking. When it enacted NOTA in 1984, Congress included a definition of the term organ and authorized the Secretary to expand this definition by regulation. The Secretary has previously exercised this authority and expanded the statutory definition of organ. Currently, the OPTN final rule defines covered organs as “a human kidney, liver, heart, lung, or pancreas, or intestine (including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract). Blood vessels recovered from an organ donor during the recovery of such organ(s) are considered part of an organ with which they are procured for purposes of this part if the vessels are intended for use in organ transplantation and labeled `For use in organ transplantation only.'”

One of the major reasons NOTA was enacted and affirmed by several amendments was to establish an organ allocation system that functions equitably on a nationwide basis with provisions for outcomes reporting and evaluation. Prior to the enactment of NOTA, deceased donor organs were allocated regionally, based on relationships between transplant programs and donor hospitals. Congress recognized the need to allocate this national resource on a national and equitable basis. To ensure equitable access for those awaiting VCA transplantation, there is a need to provide for consistency in allocation processes and reliable outcomes reporting on a nationwide basis. Appropriate Federal oversight of a national allocation system can increase safety of such transplants and provides equitable and consistent national access to such transplants while also conveying to the public that donation for such purpose will serve an essential medical need. The FDA does not have statutory authority to provide oversight of VCA allocation, outcomes reporting, or promotion of donation. The Secretary believes that the rationale for a national system of organ allocation and outcomes reporting underlying NOTA applies to VCA.

Once a body part is defined as an organ under the OPTN final rule, such body parts are excluded from the coverage of FDA regulations governing HCT/Ps. In addition, transplants involving body parts defined as organs under the OPTN final rule are subject to the requirements of the OPTN final rule. For example, entities performing transplants with covered organs must receive designation as an organ-specific designated transplant program (in this case, a designation as a VCA-specific transplant program) within an OPTN member institution. Members must comply with data submission requirements of the OPTN final rule and are subject to oversight by the OPTN contractor for compliance with OPTN policies, OPTN bylaws, and the OPTN final rule. Members may be subject to Federal enforcement actions for violations of Federal regulations or enforceable policies (those approved by the Secretary of Health and Human Services) or for actions or inactions that indicate a risk to health of patients or to the public safety. Finally, OPTN members can be subject to OPTN sanctions for violating OPTN bylaws and non-enforceable OPTN policies ( e.g., being declared a member not in good standing).

As previously discussed and also explained in “Statement of Need” within the “Impact of the New Rule” section (below), the Secretary believes that oversight of the VCA transplants is necessary to ensure transplant recipient safety and to provide a consistent allocation process nationwide that will ensure equitable access to those waiting for VCA transplantation., to collect data on VCA transplant outcomes, and to maintain the public trust in the integrity of the VCA donation, recovery and transplant processes. Because of the clinical, procurement, logistical, allocation, and outcomes reporting similarities between VCA and organs currently under the OPTN's auspices, the Secretary believes that HRSA is the appropriate HHS agency to assure Federal oversight over VCA transplantation. HRSA oversees transplantation of vascularized human organs through the OPTN, which sets policies related to the procurement, transplantation, allocation, and outcomes reporting of human organs. The OPTN serves the critical role of matching donor organs to potential recipients on a national basis. The issues concerning allocation and recipient safety are similar for VCA and for organs currently under the OPTN's auspices. Additionally, the membership of the OPTN, which is charged with developing policies consistent with the OPTN final rule, includes professionals with expertise in the field. Therefore, the Secretary believes that the OPTN, with HRSA's oversight, will be able to effectively address issues involving the regulation of the emerging field of VCA transplantation.

If VCA are included within the OPTN final rule's definition of organs, transplants involving VCA will be subject to the requirements of the OPTN final rule. For example, an entity performing VCA transplants would have to receive designation as a VCA-designated transplant program within an OPTN member institution. In addition, OPTN members would be required to comply with the OPTN final rule's data submission requirements with respect to the transplants performed. Thus, the OPTN would need to devise certain policies with respect to VCA, including allocation policies meeting the requirements set forth in the OPTN final rule. Finally, OPTN members would be subject to oversight by the OPTN contractor for compliance with OPTN policies extending to VCA ( e.g., those concerning donor screening and allocation), and could be subject to enforcement actions for violations of such policies.

Even so, the OPTN final rule does allow some flexibility specific to each organ. The OPTN sometimes fashions distinct organ-specific policies tailored to the circumstances of transplanting particular organs. For example, the training of professionals working for designated programs may vary by organ and OPTN policies with respect to disease transmission protocols and testing may diverge based on circumstances relating to particular organs. Likewise, the particular characteristics of and circumstances surrounding different types of organs lead to different OPTN allocation policies.

In addition, if VCA are added as covered organs under the OPTN final rule as proposed here, the Secretary will continue to exercise oversight over proposed and final OPTN policies with respect to VCA, consistent with the authority of the Secretary under 42 CFR 121.4. Given the relatively small numbers of other VCA transplanted at this time, the Secretary does not expect that the OPTN would develop allocation policies for all VCA within a short time frame if VCA are added to the OPTN final rule's definition of organs. We expect that the OPTN will initially create policies addressing hands and faces as these two VCA have been the most frequently performed VCA transplant procedures in the U.S. and are the subject of extensive ongoing clinical research programs by the Departments of Defense and Veterans Affairs. We expect that the OPTN will wait to develop allocation policies for other VCA until the field has more clinically evolved. Given the Secretary's substantial interest in VCA policy and involvement in the operations of the OPTN, the Secretary will be notified of proposals to develop policies for other VCA as they are addressed in the future.

The nature of the regulatory framework governing the operation of the OPTN underlies the importance of including VCA within the definition of organs covered by the OPTN final rule. Under the OPTN final rule, the OPTN must submit proposed policies for review and approval by the Secretary (42 CFR 121.4). Upon consideration of public comments on proposed policies that are considered significant, the Secretary will determine whether to make such proposed policies enforceable in accordance with section 121.10 of the OPTN final rule. The Secretary may direct the OPTN to develop individual policies for specific body components that are defined as VCA in addition to OPTN policies that apply to all VCA. Any transplant hospital that fails to comply with any policy approved as enforceable by the Secretary under this process may be subject to the enforcement sanctions delineated in section 121.10 of the OPTN final rule, including possible termination from the Medicare and Medicaid programs.

The Secretary has the following additional authorities provided by the OPTN final rule (42 CFR 121.4(b)(2)), which she may exercise in the case of policies extending to VCA: The Secretary may require the OPTN Board of Directors to provide to the Secretary, at least 60 days prior to their proposed implementation, proposed policies on matters that the Secretary directs. The Secretary will refer significant proposed policies to the Advisory Committee on Organ Transplantation (ACOT) established under 42 CFR 121.12, and publish them in the Federal Register for public comment. This is in addition to the public comment process that is engaged in by the OPTN.

The Secretary also may seek the advice of the ACOT on other proposed policies and publish them in the Federal Register for public comment.

The Secretary will determine whether proposed policies are consistent with NOTA and the OPTN final rule, taking into account the views of the ACOT and public comments. Based on this review, the Secretary may provide comments to the OPTN.

If the Secretary concludes that a proposed policy is inconsistent with NOTA or the OPTN final rule, the Secretary may direct the OPTN to revise the proposed policy consistent with the Secretary's direction. If the OPTN does not revise the proposed policy in a timely manner, or if the Secretary concludes that the proposed revision is inconsistent with NOTA or the OPTN final rule, the Secretary may take such other action as the Secretary determines appropriate, but only after additional consultation with the ACOT on the proposed action.

Also, the Secretary has the authority under the OPTN Final Rule (42 CFR 121.4(a)(6)) to require the OPTN to develop policies on such matters as the Secretary directs.

The Secretary is legally obliged, as part of her responsibilities in administering the Medicare and Medicaid programs, to require hospitals that transplant organs to comply with the rules and requirements of the OPTN as a condition of their participation in Medicare and Medicaid. (42 U.S.C. 1320b-8(a)(1)(B).) Because VCA are not included within the OPTN final rule's definition of organs, the Secretary could not currently make any VCA allocation policy enforceable. If VCA are added as covered organs under the OPTN final rule as proposed here, the Secretary could take appropriate enforcement actions against an OPO or transplant hospital for failing to comply with the OPTN's VCA retrieval and allocation policy, if such a policy has been approved as enforceable by the Secretary under the process outlined above. If VCA are defined as organs under the OPTN final rule, then this will ensure that VCA organ allocation, whether pertaining to isolated VCA transplants or combined/multi-organ transplants, is consistent with OPTN final rule's goals, including that of an equitable national system for organ allocation, to be consistent with NOTA.

Even if OPTN policies pertaining to VCA transplantation do not become enforceable, all institutions performing VCA transplantation would be required to comply with the provisions of the OPTN final rule (including the requirement that such institutions become members of the OPTN). Further, such institutions could be subject to sanctions by the OPTN for failure to comply with allocation and other OPTN policies. For example, a member may be named a member not in good standing by the OPTN for failing to comply with such a policy.

As the field of VCA transplantation evolves, it will become more critical that VCA organ allocation keeps pace with advances in the field; that the field be subject to appropriate Federal oversight; that policy developments include performance indicators to assess whether the goals of an equitable transplant system are being achieved; that the Secretary have the authority to make those policies enforceable; and that patients and physicians have timely access to accurate data that will assist them in making decisions regarding VCA transplantation. Upon consideration of the foregoing factors, and to achieve the most equitable and medically effective use of donated organs, the Secretary proposes that VCA should explicitly be added to the definition of organs covered by the OPTN final rule. The Secretary seeks comments on this proposal.

At the time of the RFI, and to assist the Secretary in adding VCA to the definition of organs covered by the OPTN final rule and/or to the definition of human organs governed by section 301 of NOTA, HRSA sought feedback from stakeholders and from the public as to how such allografts should be defined. HRSA identified two potential approaches: (1) A broad regulatory definition describing the common features of VCA without listing covered body parts; or (2) a definition listing body parts that would qualify as VCA.

The Secretary has elected to propose the first approach, a broad regulatory definition that describes the features of the allografts without listing particular body parts. Under this approach, the definition would extend to transplants of particular body parts that are not known to have been performed clinically to date, or even to body parts whose transplantation has not yet been envisioned. The Secretary is proposing which elements should be included in the definition of VCA to be sufficiently broad to cover the universe of intended body parts, but narrow enough to put the public on notice as to which parts meet the regulatory definitions of organs.

The Secretary proposes that for a body part to be defined as a VCA, it must have all the following characteristics: a body part (1) That is vascularized and requires blood flow by surgical connection of blood vessels to function after transplantation; (2) containing multiple tissue types; (3) recovered from a human donor as an anatomical/structural unit; (4) transplanted into a human recipient as an anatomical/structural unit; (5) minimally manipulated, (processing that does not alter the original relevant characteristics of the organ relating to the organ's utility for reconstruction, repair, or replacement—examples of minimal manipulation include cutting, grinding, and shaping of a VCA); (6) for homologous use, (the replacement or supplementation of a recipient's organ with an organ that performs the same basic function or functions in the recipient as in the donor), ( e.g., a hand from the donor is to be used as a hand in the recipient); (7) not combined with another article such as a device; (8) susceptible to ischemia and, therefore, only stored temporarily ( e.g., cold storage in preservation medium and intended for implantation into a recipient within hours of the recovery) and not cryopreserved; and (9) susceptible to allograft rejection, requiring immunosuppression that may increase infectious disease risk to the recipient. This proposed definition is intended to explain to the public which body parts would be covered presently, while allowing other body parts that are transplanted to be covered as the field of VCA transplantation advances. A non-exclusive list of body parts that would meet the proposed definition for VCA here would include faces, hands, fingers, toes, larynges, and abdominal walls. Periodically, HRSA may publish an updated list of VCA in the Federal Register . In addition, through this definition, the Secretary intends to distinguish those body parts she proposes to define as organs under the OPTN final rule from other body parts that are regulated as HCT/Ps under FDA's regulatory authority.

Under a second alternative, the Secretary could have proposed a definition that lists specific transplantable body parts to be added to the definition of organs ( e.g., face, hand, etc.). The Secretary finds this unnecessary since the general set of nine characteristics provide clear identification of such body parts. Moreover, definition by an explicit list would likely exclude certain body parts for which transplantation might be possible, but not done to date (either in the United States or internationally). The Secretary is proposing the more descriptive definition to avoid the need of amending the regulatory definition to extend its reach to new types of transplantation that emerge in the future.

HRSA received no negative feedback in response to its request for information on adopting this first approach or on the criteria discussed in the request for information (other than the comment distinguishing between those grafts that are lifesaving and those that are life enhancing). Most of the commenters supporting the inclusion of VCA in the definition of organs covered by the OPTN final rule would defer to the physicians and surgeons involved to determine the optimal way to define VCA. Given that Congress authorized the Department to modify the definition of covered organs through rulemaking, it would not be permissible to allow transplant surgeons and physicians (or others participating in the OPTN), on their own, to define VCA for the purposes of the final rule. However, the Secretary seeks feedback from the transplant community on the definition of VCA proposed here.

Additionally, body parts allocated as VCA are intended to be used “intact” as a VCA until the transplant center receiving the VCA determines that a portion of the VCA is not needed for transplantation of the remainder of the VCA. If portions of a VCA are not used in connection with the same transplant (for example, left over bone or tendons from a limb allocated as a VCA), such body parts cannot be used for other purposes including transplantation in a different anatomical location in the recipient who received the VCA or in a different recipient. Disposition of such remnants would be subject to OPTN policies.

Because the Secretary is proposing a definition that does not identify specific VCA by name, the Secretary proposes amending 42 CFR 121.4(e) to make clear that the OPTN must identify the specific body parts covered by any OPTN policy specific to VCA. The purpose of this proposal is to ensure that all OPTN members and stakeholders understand the body parts covered by OPTN policies specific to VCA. Under this proposal, any OPTN policy that applies broadly to organs would apply to all body parts meeting the proposed definition for VCA unless otherwise provided for.

State registries for organ and tissue donors generally provide the option to select organs, tissues, both, or neither. In the future we anticipate that states will likely further distinguish VCAs and will continue to permit individuals to select what they wish to donate. The potential impact of including VCA in the definition of organs on organ donation efforts, including the number of deceased donor organs that may become available, has not been explored. Therefore, the Secretary is seeking public comment on what impact this proposed expanded definition of organs may have on efforts to increase participation in deceased organ donor registries, signing organ donor cards, and general willingness of individuals to agree to be deceased organ donors.

The Secretary further proposes including VCA within the definition of human organs, as covered by section 301 of NOTA, which prohibits the purchase or sale of human organs for human transplantation. This criminal prohibition provides in part that “[i]t shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce. The preceding sentence does not apply with respect to human organ paired donation.” (42 U.S.C. 274e(a).) Section 301 of NOTA defines the term “human organ” to mean “the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation.” (42 U.S.C. 274e(c)(1).)

As set forth by statute, Congress authorized the Secretary to add additional organs to the definition of human organ covered by section 301 through rulemaking to include the transplantation of additional human organs within section 301's prohibition. The Secretary has previously exercised this authority. Adding VCA to this definition of human organs will subject persons violating its terms to VCA to criminal penalties.

Through this notice, the Secretary proposes to add VCA to the list of human organs covered by section 301 of NOTA. The Secretary proposes modifying 42 CFR 121.13, which includes the definition of human organs covered by section 301 of NOTA, to include VCA (as defined in the proposed amendment to section 121.2 of the OPTN final rule). Subparts are being added to this definition to conform with Public Law 100-607, which added subparts of covered human organs to the statutory definition of human organs governed by section 301 of NOTA.

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when rulemaking is necessary, to select regulatory approaches that provide the greatest net benefits (including potential economic, environmental, public health, safety, distributive and equity effects). In addition, under the Regulatory Flexibility Act, if a rule has a significant economic effect on a substantial number of small entities the Secretary must specifically consider the economic effect of a rule on small entities and analyze regulatory options that could lessen the impact of the rule.

Executive Order 12866 requires that all regulations reflect consideration of alternatives, costs, benefits, incentives, equity, and available information. Regulations must meet certain standards, such as avoiding an unnecessary burden. Regulations that are significant because of cost, adverse effects on the economy, inconsistency with other agency actions, effects on the budget, or novel legal or policy issues, require special analysis.

The Secretary has determined that minimal resources are required to implement the requirements in this rule because organizations involved ( e.g., OPOs and transplant hospitals) already implement related requirements for other organs in the OPTN rule (42 CFR 121.2). Therefore, in accordance with the Regulatory Flexibility Act of 1980 (RFA), and the Small Business Regulatory Enforcement Act of 1996, which amended the RFA, the Secretary certifies that this rule will not have a significant impact on a substantial number of small entities.

The Secretary also has determined that this proposed rule does not meet the criteria for a major rule as defined by Executive Order 12866 and would have no major effect on the economy or Federal expenditures. We have determined that the proposed rule is not a major rule within the meaning of the statute providing for Congressional Review of Agency Rulemaking, 5 U.S.C. 801. Similarly, it will not have effects on State, local, and tribal governments or on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995.

The provisions of this rule will not affect the following elements of family well-being: Family safety, family stability, marital commitment; parental rights in the education, nurture, and supervision of their children; family functioning, disposable income, or poverty; or the behavior and personal responsibility of youth, as determined under section 654(c) of the Treasury and General Government Appropriations Act of 1999.

As stated above, this proposed rule would modify the regulations governing the OPTN and section 301 of NOTA based on legal authority.

The field of VCA transplantation has advanced from the first hand transplant in the U.S. in 1999 to the point that there are now more than a dozen VCA transplant centers extending from coast to coast involving hand, face, abdominal wall, larynx, and possibly other body parts. The Departments of Defense and Veterans Affairs have invested hundreds of millions of dollars in clinical VCA transplantation research programs for the benefit of wounded warriors returning from the Iraq and Afghanistan conflicts with extensive debilitating injuries of the face and multiple extremities. Although the current activity level is less than a dozen transplants a year in the U.S., the VCA transplant community has begun to encounter the expansion problems faced in the early days of organ transplantation with ensuring equitable access for patients to VCA, uniform allocation policies across the U.S., coordination of procurement efforts, consistent application of recovery and logistics processes, and monitoring patient safety with appropriate outcomes reporting and oversight of transplant programs.

VCA transplantation consists of surgical transplants of a variety of body parts that currently do not fall within the current regulatory definition of “organ” covered by the rules governing the operation of the OPTN. Face and hand allografts, and other body parts meeting the definition of VCA in this notice, currently are subject to FDA oversight under 21 CFR parts 1270 and 1271. VCA, like organs, differ from tissues in that they must be transplanted within hours (not months or years), recipients require immunosuppression drugs to prevent or treat rejection, and the allocation process requires specific genetic and clinical matching between donor and recipient.

The FDA has no statutory or regulatory authority to mandate allocation policies, direct coordination of procurement efforts, require consistent application of recovery and logistics processes, or establish mandatory outcomes reporting and provide oversight of VCA transplant programs. In short, the FDA's authority for regulation of tissues like VCA stops at the hospital door. Only the OPTN, under HRSA oversight, can provide reliable consistent and mandatory mechanisms and infrastructure to address these problems facing the VCA transplant community. Recognizing the need for such efforts to continue to advance the field of VCA transplantation, the VCA transplant community specifically requested the Secretary of the Department of Health and Human Services to provide the necessary regulatory change to define those body parts meeting the definition of VCA in this notice as “organs” under the OPTN Final Rule so that VCA transplantation can continue to progress in an appropriate manner that will best serve the patients in need of such allografts.

This proposed rule would have the effect of including VCA within the ambit of the regulations governing the operation of the OPTN, and would include transplanted human VCA within the prohibition set forth at section 301 of NOTA. If implemented, the proposals set forth in this rule would authorize the Secretary to take enforcement actions against entities violating OPTN policies pertaining to the transplantation of VCA once such policies are approved as enforceable by the Secretary. Even if the Secretary does not approve such policies as enforceable, OPTN members will be subject to enforcement actions by the OPTN for violations of OPTN policies extending to VCA. If this rule is promulgated, OPTN members will be required to comply with requirements set forth in the OPTN final rule, including those pertaining to data submission, as applied to VCA. Finally, if this proposal is implemented, individuals violating section 301 of NOTA with respect to VCA transplants would be subject to criminal penalties.

If this rule takes effect, transplant centers that perform VCA transplantation would be required to take the necessary steps to ensure that VCA transplant programs are in compliance with any policies enacted by the OPTN specific to designated VCA allografts ( e.g. hand, face). Such policies typically specify the clinical submission requirements for candidate registration on the waiting list, clinical information of the transplant procedure, follow up reporting on graft and patient outcomes, and reporting of potential donor disease transmission events.

The amendments proposed in this notice of proposed rulemaking contain information collection activities that are very similar to, and based on the data collection requirements in, the OPTN final rule approved by the Office of Management and Budget (OMB No. 0915-0157 and OMB No. 0915-0184). Membership in the OPTN is determined by submission of application materials to the OPTN demonstrating that the applicant meets all required criteria for membership and will agree to comply with all applicable provisions of the National Organ Transplant Act, as amended, 42 U.S.C. 273 et seq. Section 1138 of the Social Security Act, as amended, 42 U.S.C. 1320b-8 requires that hospitals in which transplants are performed be members of, and abide by, the rules and requirements (as approved by the Secretary of the HHS) of the OPTN as a condition of participation in Medicare and Medicaid for the hospital. Section 1138 contains a similar provision for the organ procurement organizations (OPOs) and makes membership in the OPTN and compliance with its operating rules and requirements (as approved by the Secretary of the HHS), including those relating to data collection, mandatory for all transplant programs and OPOs. The information is used predominantly to match donor organs with recipients, to monitor compliance of member organizations with OPTN policies and requirements to guide organ allocation policy development, and to report periodically on the clinical and scientific status of organ donation and transplantation in this country.

The currently-approved data collection includes worksheets and burden for organs and describes respondents as non-profit institutions and small organizations, which would be the same for this proposed rule. The title, description, and respondent description of all information collections relating to VCA are shown below with similar estimates of annual reporting and record keeping burden as with other organs previously approved in the OPTN final rule.

Currently there are approximately 10 hand, 2 face, and 1 abdominal wall transplant programs in the U.S., although only 7 have actually performed a clinical transplant operation to date. Since the current rate of VCA transplants is less than 10 a year (hand) and less than 1 a year (face and abdominal wall), for reporting burden calculations (below) we have projected a total of 20 VCA transplant programs each registering 2 candidates a year to the waiting list and each program performing 1 transplant procedure a year. The data burden calculation in the table below assumes that data associated with entering deceased donor information is already accounted in the current OMB approved data collection forms. Specifically, it is reasonable to assume that any donor that would be considered as a VCA donor is also considered to be a donor for other organs covered by this rule. The hourly rate used for calculation of total burden cost to respondents is the average hourly wage for a transplant data coordinator ($26.00). This rate reflects the median annual salary and benefits for a Data Control Clerk II (www.salary.com) The total annual respondent burden hours (202) represents 10.1 hours ($262.60) per respondent.

Title: Organ Procurement and Transplantation Network.

Description: Information will be collected from transplant hospitals, organ procurement organizations, and histocompatibility laboratories predominantly for the purpose of matching donor VCA with potential recipients, monitoring compliance of member organizations with system rules, conducting statistical analyses, and developing policies relating to organ procurement and transplantation.

The practical utility of the data collection is further enhanced by requirements that the OPTN must report a variety of data to the Secretary, including data on performance by organ and status category, including program-specific data, OPO specific data, data by program size, and data aggregated by organ procurement area, OPTN region, the nation as a whole, and other geographic areas (42 CFR 121.8(c)(3)). The OPTN must also transmit proposed allocation policies and performance indicators which will be used to assess the likely effects of policy changes and to ensure that the proposed policies are consistent with the OPTN final rule.

The OPTN and Scientific Registry must make available to the public timely and accurate information concerning the performance of transplant programs, and must respond to requests from the public for data needed for bona fide research or analysis purposes or to assess the performance of the OPTN or Scientific Registry, to assess individual transplant programs, or for other purposes (42 CFR 121.11(b)(1)(C)).

The OPTN must provide to each member OPO and transplant hospital the plans and procedures for reviewing applications and for monitoring compliance with these rules and OPTN policies. The OPTN must also report to the Secretary on OPOs and transplant hospitals that may not be in compliance with these rules or OPTN policies, and on their progress toward compliance.

The OPTN and Scientific Registry are required to maintain and manage the information on candidates, donors and recipients.

Description of Respondents: Non-profit institutions and small organizations. The estimated annual reporting burden is as follows:

Accordingly, 42 CFR part 121 is proposed to be amended as set forth below: