This rule is issued under Marketing Order Nos. 916 and 917, both as amended (7 CFR parts 916 and 917), regulating the handling of nectarines and peaches grown in California, respectively, hereinafter referred to as the “orders.” The orders are effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Order 12866.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing orders now in effect, California nectarine and peach handlers are subject to assessments. Funds to administer the orders are derived from such assessments. It is intended that the assessment rates as proposed herein would be applicable to all assessable nectarines and peaches beginning on March 1, 2010, and continue until amended, suspended, or terminated.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This rule would increase the assessment rates established for the Nectarine Administrative Committee (NAC) for the 2010-11 and subsequent fiscal periods from $0.0175 to $0.0280 per 25-pound container or container equivalent of nectarines and for the Peach Commodity Committee (PCC) for the 2010-11 and subsequent fiscal periods from $0.0025 to $0.026 per 25-pound container or container equivalent of peaches.

The nectarine and peach marketing orders provide authority for the Committees, with the approval of USDA, to formulate annual budgets of expenses and collect assessments from handlers to administer the programs. The members of NAC and PCC are producers of California nectarines and peaches, respectively. They are familiar with the Committees' needs, and with the costs for goods and services in their local area and are, therefore, in a position to formulate appropriate budgets and assessment rates. The assessment rates are formulated and discussed in public meetings. Thus, all directly affected persons have an opportunity to participate and provide input.

For the 2009-10 and subsequent fiscal periods, the NAC recommended, and USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA.

The NAC met on December 10, 2009, and unanimously recommended 2010-11 expenditures of $1,448,101 and an assessment rate of $0.0280 per 25-pound container or container equivalent of nectarines. In comparison, the budgeted expenditures for the 2009-10 fiscal period were $1,797,290. The assessment rate of $0.0280 per 25-pound container or container equivalent of nectarines is $0.0105 higher than the rate currently in effect. The NAC recommended a higher assessment rate because the 2009 crop was lower than expected due to a large number of tree pullouts and other economic factors.

The major expenditures recommended by the NAC for the 2010-11 fiscal period include $291,377 for administration, $157,016 for production research, and $999,708 for domestic and international programs. In comparison, budgeted expenses for these items in 2008-09 were $319,965.32 for administration, $349,447.55 for production research, and $1,127,877.33 for domestic and international programs.

The assessment rate recommended by the NAC was derived after considering anticipated fiscal year expenses; estimated assessable nectarines of 16,200,000 25-pound containers or container equivalents; the estimated income from other sources, such as interest; and the need for an adequate financial reserve to carry the NAC into the 2011-12 fiscal period. Therefore, the NAC recommended an assessment rate of $0.0280 per 25-pound container or container equivalent.

Combining expected assessment revenue of $453,600 with the $641,840 carryover available from the 2009-10 fiscal period and other income such as interest should be adequate to meet Committee needs. The assessment rate is also likely to provide a $116,486 reserve, which may be used to cover administrative expenses prior to the beginning of the 2011-12 shipping season as provided in the order (§ 916.42).

For the 2009-10 and subsequent fiscal periods, the PCC recommended, and USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA.

The PCC met on December 10, 2009, and recommended 2010-11 expenditures of $1,839,651 and an assessment rate of $0.026 per 25-pound container or container equivalent of peaches. In comparison, budgeted expenditures for the 2009-10 fiscal period were $1,885,250. The assessment rate of $0.026 per 25-pound container or container equivalent of peaches is $0.0235 higher than the rate currently in effect. The PCC recommended a higher assessment rate because the 2009 crop was lower than expected due to a large number of tree pullouts and other economic factors.

The major expenditures recommended by the PCC for the 2010-11 fiscal period include $368,756 for administration, $199,662 for production research, and $1,271,233 for domestic and international programs. In comparison, budgeted expenses for these items in 2009-10 were $334,058 for administration, $366,920 for production research, and $1,184,272 for domestic and international programs.

The assessment rate recommended by the PCC was derived after considering anticipated fiscal year expenses; estimated assessable peaches of 20,600,000 25-pound containers or container equivalents; the estimated income from other sources, such as interest; and the need for an adequate financial reserve to carry the PCC into the 2011-12 fiscal period. Therefore, the PCC recommended an assessment rate of $0.026 per 25-pound container or container equivalent.

Combining expected assessment revenues of $535,600 with the $854,699 carryover available from the 2009-10 fiscal period and other income such as interest should be adequate to meet Committee needs. The assessment rate is also likely to provide a $147,502 reserve, which may be used to cover administrative expenses prior to the beginning of the 2011-12 shipping season as provided in the order (§ 917.38).

The proposed assessment rates would continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committees or other available information.

Although these assessment rates would be in effect for an indefinite period, the Committees will continue to meet prior to or during each fiscal period to recommend budgets of expenses and consider recommendations for modification of the assessment rates. The dates and times of Committee meetings are available from the Committees' Web site at http://www.eatcaliforniafruit.com or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA would evaluate the Committees' recommendations and other available information to determine whether modification of the assessment rate for each Committee is needed. Further rulemaking would be undertaken as necessary. The Committees' 2010-11 fiscal period budgets and those for subsequent fiscal periods would be reviewed and, as appropriate, approved by USDA.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 101 California nectarine and peach handlers subject to regulation under the orders covering nectarines and peaches grown in California, and about 475 producers of these fruits in California. Small agricultural service firms, which include handlers, are defined by the Small Business Administration (SBA) (13 CFR 121.201) as those having annual receipts of less than $7,000,000, and small agricultural producers are defined as those having annual receipts of less than $750,000. A majority of these handlers and producers may be classified as small entities.

The Committees' staff has estimated that there are fewer than 50 handlers in the industry who would not be considered small entities. For the 2009 season, the committees' staff estimated that the average handler price received was $11.50 per container or container equivalent of nectarines or peaches. A handler would have to ship at least 608,696 containers to have annual receipts of $7,000,000. Given data on shipments maintained by the committees' staff and the average handler price received during the 2009 season, the Committees' staff estimates that small handlers represent approximately 50 percent of all the handlers within the industry.

The Committees' staff has also estimated that fewer than 50 producers in the industry would not be considered small entities. For the 2009 season, the Committees estimated the average producer price received was $6.50 per container or container equivalent for nectarines and peaches. A producer would have to produce at least 115,385 containers of nectarines and peaches to have annual receipts of $750,000. Given data maintained by the Committees' staff and the average producer price received during the 2009 season, the Committees' staff estimates that small producers represent more than 80 percent of the producers within the industry.

With an average producer price of $6.50 per container or container equivalent, and a combined packout of nectarines and peaches of 37,263,343 containers, the value of the 2009 packout is estimated to be $242,211,730. Dividing this total estimated grower revenue figure by the estimated number of producers (475) yields an estimate of average revenue per producer of about $509,919 from the sales of peaches and nectarines.

The nectarine and peach marketing orders provide authority for the Committees, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the programs. The members of the NAC and PCC are producers of California nectarines and peaches, respectively.

This rule would increase the assessment rates established for the NAC for the 2010-11 and subsequent fiscal periods from $0.0175 to $0.0280 per 25-pound container or container equivalent of nectarines and for the PCC for the 2010-11 and subsequent fiscal periods from $0.0025 to $0.026 per 25-pound container or container equivalent of peaches.

The NAC recommended 2010-11 fiscal period expenditures of $1,448,101 for nectarines and an assessment rate of $0.0280 per 25-pound container or container equivalent of nectarines. The assessment rate of $0.0280 is $0.0105 higher than the rate currently in effect. The PCC recommended 2010-11 fiscal period expenditures of $1,839,651 for peaches and an assessment rate of $0.026 per 25-pound container or container equivalent of peaches. The assessment rate of $0.026 is $0.0235 higher than the rate currently in effect.

The quantity of assessable nectarines for the 2010-11 fiscal period is estimated at 16,200,000 25-pound containers or container equivalents. Thus, the $0.0280 rate should provide $453,600 in assessment income. Income derived from handler assessments, along with income from other sources and funds from the NAC's reserve, would be adequate to cover budgeted expenses.

The major expenditures recommended by the NAC for the 2010-11 year include $291,377 for administration, $157,016 for production research, and $999,708 for domestic and international programs. Budgeted expenses in 2009-10 were $319,965.32 for administration, $349,447.55 for production research, and $1,127,877.33 for domestic and international programs.

The NAC recommended an increased 2010-11 fiscal period assessment rate because the 2009 crop was lower than expected due to a large number of tree pullouts and other economic factors. Income generated from the higher assessment rate combined with reserve funds should be adequate to cover anticipated 2010-11 expenses.

The quantity of assessable peaches for the 2010-11 fiscal year is estimated at 20,600,000 25-pound containers or container equivalents. Thus, the $0.026 rate should provide $535,600 in assessment income.

The major expenditures recommended by PCC for the 2010-11 year include $368,756 for administration, $199,662 for production research, and $1,271,233 for domestic and international programs. Budgeted expenses in 2009-10 were $334,058 for administration, $366,920 for production research, and $1,184,272 for domestic and international programs.

The PCC recommended an increased 2010-11 fiscal period assessment rate because the 2009 crop was lower than expected due to a large number of tree pullouts and other economic factors. Income generated from the higher assessment rate combined with reserve funds should be adequate to cover anticipated 2010-11 expenses.

Prior to arriving at these budgets, the Committees considered alternative expenditure and assessment rate levels, but ultimately decided that the recommended levels were reasonable to properly administer the orders.

Each of the Committees then reviewed the proposed expenses; the total estimated assessable 25-pound containers or container equivalents; and the estimated income from other sources, such as interest income, prior to recommending a final assessment rate. The NAC decided that an assessment rate of $0.0280 per 25-pound container or container equivalent will allow it to meet its 2010-11 fiscal period expenses and carryover an operating reserve of about $116,486 which is in line with the Committee's financial needs. The PCC decided that an assessment rate of $0.026 per 25-pound container or container equivalent will allow it to meet its 2010-11 fiscal period expenses and carryover an operating reserve of $147,502. These assessment rates would allow them to meet their 2010-11 fiscal period expenses and carryover necessary reserves to finance operations before 2011-12 fiscal period assessments are collected.

A review of historical and preliminary information pertaining to the upcoming fiscal period indicates that the grower price for nectarines and peaches for the 2010-11 season could range between $6.00 and $8.00 per 25-pound container or container equivalent. Therefore, the estimated assessment revenue for the 2010-11 fiscal period as a percentage of total grower revenue could range between 0.33 and 0.47 percent.

This action would increase the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. Some of the additional costs may be passed on to producers. However, these costs would be offset by the benefits derived by the operation of the marketing order. In addition, the Committees' meetings were widely publicized throughout the California nectarine and peach industries and all interested persons were invited to attend the meetings and were encouraged to participate in the Committees' deliberations on all issues. Like all Committee meetings, the December 10, 2009, meetings were public meetings and entities of all sizes were able to express views on this issue. Finally, interested persons are invited to submit information on the regulatory and informational impacts of this action on small businesses.

This proposed rule would impose no additional reporting or recordkeeping requirements on either small or large handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

AMS is committed to complying 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.

USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template=TemplateN&page=MarketingOrdersSmallBusinessGuide. Any questions about the compliance guide should be sent to Antoinette Carter at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

A 30-day comment period is provided to allow interested persons to respond to this proposed rule. Thirty days is deemed appropriate because: (1) The 2010-11 fiscal period begins March 1, 2010, and the marketing orders require that the rates of assessment for each fiscal period apply to all assessable nectarines and peaches handled during such fiscal period; (2) the Committees need to have sufficient funds to pay its expenses which are incurred on a continuous basis; (3) handlers are aware of this action which was unanimously recommended by the Committees at public meetings and is similar to other assessment rate actions issued in past years.

For the reasons set forth in the preamble, 7 CFR parts 916 and 917 are proposed to be amended as follows:

1. The authority citation for 7 CFR parts 916 and 917 continues to read as follows:

Table of Contents I. Background and Authority II. Summary of the Proposal III. Discussion A. Integrated Annual Fuel Utilization Efficiency (AFUEI) B. Proposed Amendments Relationship With Energy Conservation Standards C. Compliance With Other EPCA Requirements IV. Procedural Requirements V. Public Participation VI. Approval of the Office of the Secretary I. Background and Authority

Title III of the Energy Policy and Conservation Act (42 U.S.C. 6291 et seq.; EPCA or the Act) sets forth a variety of provisions designed to improve energy efficiency. Part A of Title III (42 U.S.C. 6291-6309) establishes the “Energy Conservation Program for Consumer Products Other Than Automobiles,” including residential furnaces and boilers (all of which are referenced below as “covered products”).1 (42 U.S.C. 6291(1)-(2) and 6292(a)(5)).

Under the Act, this program consists essentially of three parts: (1) Testing; (2) labeling; and (3) establishing Federal energy conservation standards. The testing requirements consist of test procedures that manufacturers of covered products must use as the basis for certifying to DOE that their products comply with applicable energy conservation standards adopted under EPCA and for representing the efficiency of those products. Similarly, DOE must use these test procedures to determine whether the products comply with standards adopted under EPCA. Under 42 U.S.C. 6293, EPCA sets forth criteria and procedures for DOE's adoption and amendment of such test procedures. EPCA provides that “[a]ny test procedures prescribed or amended under this section shall be reasonably designed to produce test results which measure energy efficiency, energy use, * * * or estimated annual operating cost of a covered product during a representative average use cycle or period of use, as determined by the Secretary [of Energy], and shall not be unduly burdensome to conduct.” (42 U.S.C. 6293(b)(3)) In addition, if DOE determines that a test procedure amendment is warranted, it must publish proposed test procedures and offer the public an opportunity to present oral and written comments on them. (42 U.S.C. 6293(b)(2)) Finally, in any rulemaking to amend a test procedure, DOE must determine “to what extent, if any, the proposed test procedure would alter the measured energy efficiency * * * of any covered product as determined under the existing test procedure.” (42 U.S.C. 6293(e)(1)) If DOE determines that the amended test procedure would alter the measured efficiency of a covered product, DOE must amend the applicable energy conservation standard accordingly. (42 U.S.C. 6293(e)(2))

On December 19, 2007, the Energy Independence and Security Act of 2007 (EISA 2007), Public Law 110-140, was enacted. The EISA 2007 amendments to EPCA, in relevant part, require DOE to amend the test procedures for all covered products to include measures of standby mode and off mode energy consumption. Specifically, section 310 of EISA 2007 provides definitions of “standby mode” and “off mode” (42 U.S.C. 6295(gg)(1)(A)) and permits DOE to amend these definitions in the context of a given product (42 U.S.C. 6295(gg)(1)(B)). The legislation requires integration of such energy consumption “into the overall energy efficiency, energy consumption, or other energy descriptor for each covered product, unless the Secretary determines that—

(i) The current test procedures for a covered product already fully account and incorporate the standby and off mode energy consumption of the covered product; or

(ii) Such an integrated test procedure is technically infeasible for a particular covered product, in which case the Secretary shall prescribe a separate standby mode and off mode energy use test procedure for the covered product, if technically feasible.” (42 U.S.C. 6295(gg)(2)(A))

DOE's current test procedure for residential furnaces and boilers is found at 10 CFR part 430, subpart B, appendix N. DOE established its test procedures for furnaces and boilers in a final rule published in the Federal Register on May 12, 1997. 62 FR 26140. This procedure establishes a means for determining annual energy efficiency and annual energy consumption of gas-fired, oil-fired, and electric furnaces and boilers.

DOE notes that gas-fired and oil-fried furnaces and boilers consume both fossil fuel and electricity, while electric furnaces and boilers only consume electricity. The current test procedure accounts for all fossil-fuel energy consumption over a full-year cycle, thereby satisfying EISA 2007 requirements for fossil-fuel standby mode and off mode energy consumption. Electrical energy consumption in standby mode and off mode, however, is not accounted for in the current test procedure.

In the July 2007 NOPR, DOE proposed to add standby mode and off mode energy consumption measurement provisions utilizing the IEC 62301 standard. Standby and off mode electrical energy consumption would not, however, be integrated into AFUE. On further review, DOE has determined that integration of standby and off mode electrical energy consumption into AFUE is technically feasible. Accordingly, this notice proposes an integrated annual fuel utilization efficiency metric.

As mentioned above, DOE has determined that integration of standby mode and off mode electrical energy consumption into the AFUE efficiency descriptor is technically feasible. AFUE is the required energy efficiency descriptor for furnaces. (42 U.S.C. 6291(22)). EISA 2007 requires, if technically feasible, integration of standby energy consumption into the overall energy efficiency, energy consumption or other energy descriptor. Therefore, EISA 2007 requires an integrated AFUE that reflects standby mode and off mode energy consumption for both fossil fuel and electricity. This notice proposes such integration into the AFUE descriptor.

The proposed integrated annual fuel utilization efficiency (AFUEI) would be the mathematical product of the current AFUE measure and an efficiency quotient that includes, as an addition to the denominator, the standby mode and off mode electricity consumption converted to Btu based on the point-of-use energy content of a kilowatt hour (3412 Btu). This addition would thereby reduce the numeric value of the efficiency quotient in proportion to the relative magnitude of such additional energy consumption. This mathematical form is consistent with how other products have addressed EISA 2007, in particular how the standby mode and off mode energy consumption is integrated into existing efficiency descriptors.

This proposed formula would use the point-of-use energy content of a kilowatt hour (3412 Btu) because the statute defines “energy use” as “the quantity of energy directly consumed by a consumer product at point of use” (42 U.S.C. 6291 (4)) DOE recognizes that combining fossil fuel (natural gas) and electricity consumption based on their point-of-use energy content tends to understate the relative energy and economic impacts of the electricity use. However, DOE proposes an integrated metric given the statutory definition of energy use and the statutory mandate to establish an integrated measure of energy efficiency, if technically feasible. Furthermore, in this case, DOE expects that the possible distortions resulting from the combination of fossil fuel and electricity measures of point-of-use energy use are likely to be very small. DOE invites comment on this approach to combining the natural gas and electricity use of furnaces. DOE also invites comment on modifications that can be made to the adjustment factor that can more accurately characterize the relative impacts of electricity and fossil fuel use while maintaining consistency with existing statute.

Because there are some slight differences in the terminology and formulation used in the existing test procedure for electric furnaces and boilers as compared to fossil fueled furnaces and boilers, DOE discusses the proposed integrated AFUEI separately for each product in the following paragraphs.

For fossil fueled furnaces and boilers, the proposed integrated annual fuel utilization efficiency would be expressed as a function of the useful heat energy provided by the primary fuel divided by the sum of the primary fuel energy consumption and the standby mode and off mode energy consumption with all terms in equivalent energy units.

The mathematical form of the expression would be as follows:

For electric furnaces and boilers, the proposed integrated annual utilization efficiency would be presented as the useful heat provided by the annual total electrical energy minus the off mode annual energy consumption all divided by the annual total electrical consumption.

The mathematical form of the expression would be as follows:

This integrated AFUE for electric furnaces and boilers, although seemingly different in mathematical form, is conceptually the same as the integrated AFUE for fossil fueled furnaces and boilers. Specifically, it is an integrated efficiency quotient that includes, as an addition to the denominator, the standby mode and off mode energy consumption. The differences result from the fact the there is no need for a conversion to equivalent energy units and the existing test procedure's energy consumption terms are structured differently for electric furnaces and boilers as compared to fossil fueled furnaces and boilers. The different structure results from the existing test procedure's assumption that auxiliary electrical energy consumption provides useful heat to the heated space. This assumption applies when one considers the standby mode but not off mode because the electric energy consumption during the non heating season is not considered useful heat. The proposed equation for electric furnaces and boilers recognizes this difference.

Today's proposal would integrate standby and off mode electrical energy use into the AFUE efficiency descriptor, as required by EPCA. (42 U.S.C. 6295(gg)(2)(A)) DOE will consider use of this proposed efficiency descriptor in any rulemaking procedure to prescribe standards for furnaces and boilers, again as required by EPCA. (42 U.S.C. 6295(gg)(3)).

EPCA requires that “[a]ny test procedures prescribed or amended under this section shall be reasonably designed to produce test results which measure energy efficiency, energy use * * * or estimated annual operating cost of a covered product during a representative average use cycle or period of use * * * and shall not be unduly burdensome to conduct.” (42 U.S.C. 6293(b)(3))

Today's supplemental proposed amendments to the DOE test procedure would only add two new equations to the calculation section of the test procedure. These calculations utilize existing or proposed terms and, accordingly, pose no additional testing burden.

DOE has concluded that the determinations made pursuant to the various procedural requirements applicable to the July 27 NOPR remain unchanged for this SNOPR. These determinations are set forth in the July 27 NOPR. (74 FR 36959, 36966-68 July 27, 2009)

DOE will accept comments, data, and information regarding the proposed rule no later than the date provided at the beginning of this notice. Comments, data, and information submitted to DOE's e-mail address for this rulemaking should be provided in WordPerfect, Microsoft Word, PDF, or text (ASCII) file format. Stakeholders should avoid the use of special characters or any form of encryption, and wherever possible comments should include the electronic signature of the author. Comments, data, and information submitted to DOE via mail or hand delivery/courier should include one signed paper original. No telefacsimiles (faxes) will be accepted.

Pursuant to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit two copies: One copy of the document that includes all of the information believed to be confidential, and one copy of the document with that information deleted. DOE will determine the confidential status of the information and treat it accordingly.

Factors of interest to DOE when evaluating requests to treat submitted information as confidential include the following: (1) A description of the items; (2) whether and why such items are customarily treated as confidential within the industry; (3) whether the information is generally known by or available from other sources; (4) whether the information was previously made available to others without obligation concerning its confidentiality; (5) an explanation of the competitive injury to the submitting person that would result from public disclosure; (6) when such information might lose its confidential character due to the passage of time; and (7) why disclosure of the information would be contrary to the public interest.

The Secretary of Energy has approved publication of this notice of proposed rulemaking.

For the reasons stated in the preamble, DOE proposes to amend part 430 of chapter II of title 10 of the Code of Federal Regulations, to read as set forth below:

(1) OMB No.: 1910-5104. (2) Collection Title: Title 10 of the Code of Federal Regulations, Part 431—Energy Efficiency Program for Certain Commercial and Industrial Equipment: Subpart B—Electric Motors: 10 CFR 431.36, Compliance Certification, “Certification of Compliance with Energy Efficiency Standards for Electric motors.” Appendix C to Subpart B of Part 431—Compliance Certification. (3) Type of Review: Reinstatement, without change, of a previously approved collection for which approval has expired. (4) Purpose: The purpose of the collection is two-fold: (a) To require the manufacturer or private labeler of certain commercial or industrial electric motors subject to energy efficiency standards prescribed under section 342(b) of EPCA to establish, maintain, and retain records of its test data and subsequent verification of any alternative efficiency determination method used under part 431, et seq.; and (b) to preclude distribution in commerce of any basic model of commercial or industrial electric motor that is subject to an energy efficiency standard set forth under subpart B of part 431, unless the manufacturer or private labeler of that motor has submitted a Compliance Certification to DOE according to the provisions under 10 CFR 431.36, certifying that the basic model meets the requirements of the applicable standard. This information ensures compliance with the energy efficiency standards for certain commercial and industrial electric motors. (5) Estimated Number of Respondents: There are approximately 100 manufacturers and private labelers that distribute in commerce in the United States electric motors covered under 10 CFR part 431, et seq. (6) Estimated Total Burden Hours: There are approximately 300 total recordkeeping and reporting hours (3 hours per manufacturer or private labeler) at a total annualized cost of approximately $20,000 ($200 per manufacturer or private labeler). (7) Number of Collections: The request contains one information and recordkeeping requirement for all manufacturers or private labelers.

Background: Section 325(y) of the Energy Policy and Conservation Act (EPCA), 42 U.S.C. 6295(y), establishes energy conservation standards for certain distribution transformers. On July 25, 2006, DOE published a Notice of Proposed Rulemaking (71 FR 42216) to set forth Compliance Certification requirements under 10 CFR 431.371(a)(6)(ii), (b)(1), and appendix C to subpart T. These requirements were finalized on January 5, 2010 (75 FR 652) and became effective February 4, 2010. The Compliance Certification reports on and certifies compliance with the requirements for distribution transformers. It has two elements: a compliance statement that certifies compliance with the requirements contained in 10 CFR part 431 (Energy Conservation Program for Certain Commercial and Industrial Equipment), and a certification report that provides energy efficiency information for each basic model of distribution transformer that a manufacturer or private labeler distributes in commerce in the United States. It is the basis for the energy efficiency information marked on the permanent nameplate of a distribution transformer which enables purchasers to compare the energy efficiencies of similar distribution transformers. The information contained in the compliance statements and certification reports facilitates compliance with and enforcement of the energy efficiency standards established for distribution transformers under 325(y) of EPCA, 42 U.S.C. 6295(y).

(1) OMB No.: 1910-5130. (2) Collection Title: Title 10 of the Code of Federal Regulations, Part 431—Energy Efficiency Program for Certain Commercial and Industrial Equipment: Subpart K—Distribution Transformers: 10 CFR 431.197, Manufacturer's determination of efficiency for distribution transformers; Subpart T—Certification and Enforcement: 10 CFR 431.371(a)(6)(ii), (b)(1), Certification, and appendix C to subpart T—Certification Report for Distribution Transformers. (3) Type of Review: Extension of a currently approved collection. (4) Purpose: The purpose of the collection is two-fold. First, it requires the manufacturer or private labeler of certain commercial or industrial distribution transformers subject to energy efficiency standards prescribed under 10 CFR 431.196 to establish, maintain, and retain records of its test data and subsequent verification of any alternative efficiency determination method used under part 431, et seq. Second, it allows DOE to determine whether, for any basic model of commercial or industrial distribution transformer that is subject to an energy efficiency standard set forth under subpart K of part 431, the manufacturer or private labeler of that distribution transformer has submitted a Compliance Certification to DOE according to the provisions under 10 CFR 431.371(a)(6)(ii) and (b)(1). By its submission, the manufacturer or private labeler is certifying that the basic model meets the requirements of the applicable standard. This information ensures compliance with the energy efficiency standards for certain commercial and industrial distribution transformers. (5) Estimated Number of Respondents: There are approximately 100 manufacturers and private labelers that distribute in commerce in the United States distribution transformers covered under 10 CFR part 431, et seq. (6) Estimated Total Burden Hours: There are approximately 96 total recordkeeping and reporting hours per company per year at a total annualized cost of approximately $1,300 dollars per respondent. (7) Number of Collections: The request contains one information and recordkeeping requirement for all manufacturers or private labelers.

Title III of the Energy Policy and Conservation Act of 1975, as amended, (EPCA or the Act) sets forth a variety of provisions designed to improve energy efficiency. Part B of Title III (42 U.S.C. 6291-6309) provides for the Energy Conservation Program for Consumer Products Other Than Automobiles. The National Energy Conservation Policy Act (NECPA), Public Law 95-619, amended EPCA to add Part C of Title III, which established an energy conservation program for certain industrial equipment. (42 U.S.C. 6311-6317) (For purposes of codification in Title 42 of the U.S. Code, these parts were subsequently redesignated as Parts A and A-1, respectively, for editorial reasons.) Section 312 of the Energy Independence and Security Act of 2007 (EISA 2007) further amended EPCA by adding certain equipment to this energy conservation program, including walk-in coolers and walk-in freezers (collectively “walk-in equipment” or “walk-ins”), which are the subject of this rulemaking. (42 U.S.C. 6311(1), (20), 6313(f) and 6314(a)(9))

DOE is required to design each standard for this equipment to: (1) Achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified, and (2) result in significant conservation of energy. (42 U.S.C. 6295(o)(2)(A) and (o)(3), 42 U.S.C. 6313(f)(4)(A); see 42 U.S.C. 6295(o)(2)(A) and (o)(3)(B)) To determine whether a proposed standard is economically justified, DOE will, after receiving comments on the proposed standard, determine whether the benefits of the standard exceed its burdens to the greatest extent practicable, considering the following seven factors:

1. The economic impact of the standard on manufacturers and consumers of equipment subject to the standard;

2. The savings in operating costs throughout the estimated average life of the covered equipment in the type (or class) compared to any increase in the price, initial charges, or maintenance expenses for the covered equipment which are likely to result from the imposition of the standard;

3. The total projected amount of energy savings likely to result directly from the imposition of the standard;

4. Any lessening of the utility or the performance of the covered equipment likely to result from the imposition of the standard;

5. The impact of any lessening of competition, as determined in writing by the Attorney General, that is likely to result from the imposition of the standard;

6. The need for national energy conservation; and

7. Other factors the Secretary [of Energy] considers relevant.

(See 42 U.S.C. 6295(o)(2)(B)(i); 6313(f)) For walk-ins, DOE is applying those factors in a manner consistent with its other energy conservation standards rulemakings to ascertain the maximum improvement in energy efficiency that is technologically feasible and economically justified for this equipment.

Prior to proposing a standard, DOE typically seeks public input on the analytical framework, models, and tools that DOE will use to evaluate standards for the product at issue; the results of preliminary analyses DOE performed for the product; and potential energy conservation standard levels derived from these analyses that DOE could consider. DOE is publishing this document to announce the availability of the preliminary technical support document (TSD), which details the preliminary analyses, discusses the comments on the framework document, and summarizes the preliminary results of DOE's analyses. In addition, DOE is announcing a public meeting to solicit feedback from interested parties on its analytical framework, models, and preliminary results.

EPCA requires the Secretary to publish performance-based standards for walk-ins no later than January 1, 2012. The standards must apply to products manufactured beginning 3 years after the date the final rule is published unless DOE determines, by rule, that such period is inadequate. If DOE makes such a determination, DOE may establish a period of up to 5 years for the standards to become applicable. (42 U.S.C. 6313(f)(4)) To address this requirement, DOE is developing standards for walk-in coolers and walk-in freezers that achieve the maximum improvement in energy that is technologically feasible and economically justified.

In addition to requiring the promulgation of performance standards for walk-ins, EPCA also contains prescriptive standards (i.e., design requirements) for walk-in coolers and walk-in freezers manufactured on or after January 1, 2009. (42 U.S.C. 6313(f)(1)-(3)) These prescriptive standards require that walk-ins have specific components or design characteristics, each of which is intended to reduce the energy use of the equipment. DOE is not proposing to amend these requirements, but rather to develop new standards that further improve the energy efficiency of the equipment by regulating its overall energy use (i.e., performance). Manufacturers would be permitted to meet the new standards with a variety of components or designs that satisfy the prescriptive standards mandated by EPCA. Accordingly, this rulemaking would not modify any of EPCA's prescriptive standards for walk-in equipment.

Further, EPCA directs the Secretary to establish a test procedure to measure the energy use of walk-in coolers and walk-in freezers. (42 U.S.C. 6314(a)(9)(B)(i)) DOE is conducting a separate rulemaking to develop this test procedure and published a notice of proposed rulemaking (NOPR) for the test procedure on January 4, 2010. In the test procedure NOPR, DOE proposed to consider the two components that comprise a walk-in—the insulated envelope and the refrigeration system—as two separate pieces of equipment, and proposed separate test procedures for each of these components. DOE considered this approach because it received comments from interested parties stating that the two components are often produced by different manufacturers and may be assembled by a third party, and for other reasons as well. 75 FR 186 (January 4, 2010)

DOE anticipated that it would take a similar approach to performance standards for walk-ins; that is, it would create separate standards for the envelope and the refrigeration system. Thus, the preliminary analyses reflect this approach. DOE explains the approach further and addresses its implications in the preliminary TSD.

To initiate this rulemaking, DOE prepared a framework document, “Rulemaking Framework for Walk-in Coolers and Walk-in Freezers,” that describes the procedural and analytical approaches DOE anticipated using to evaluate the establishment of energy conservation standards for walk-ins. DOE published a notice that announced both the availability of the framework document and a public meeting to discuss the proposed analytical framework for the rulemaking, and that invited written comments on the conduct of the rulemaking. 74 FR 411 (January 6, 2009). The framework document is available at: http://www1.eere.energy.gov/buildings/appliance_standards/commercial/wicf_framework_document.html. DOE held the public meeting on February 4, 2009, at which it described the various rulemaking analyses DOE would conduct, such as the engineering analysis, the life-cycle cost (LCC) and payback period (PBP) analyses, and the national impact analysis (NIA); the methods for conducting them; and the relationship among the various analyses. Manufacturers, trade associations, and environmental advocates attended the meeting. The participants discussed the following major issues: Creation of separate standards for the insulated envelope and the refrigeration system of a walk-in; compliance, enforcement, and labeling provisions; test procedures; distribution channels; discount rates; monetization of emission reductions; and interpretation and enforcement of the EPCA's prescriptive requirements for walk-in equipment.

DOE developed two spreadsheets for analyzing the economic impacts of standard levels—one that calculates LCC and PBP, and one that calculates national impacts. (For the NOPR, DOE will also develop a spreadsheet that will evaluate the financial impacts on walk-in manufacturers that may result from a standard level.) DOE prepared an LCC and PBP spreadsheet that calculates results for each of the representative units analyzed. This spreadsheet includes equipment efficiency data that allows users to determine LCC savings and PBPs based on average values, and can be combined with Crystal Ball (a commercially available software program) to generate a Monte Carlo simulation, incorporating uncertainty and variability considerations. The second economic spreadsheet calculates the impacts of candidate standard levels on shipments and the national energy savings (NES) and net present value (NPV) at various standard levels. There is one national impact analysis spreadsheet for all walk-in coolers and walk-in freezers. DOE has posted both economic spreadsheets on its website for review and comment by interested parties.

Comments received since publication of the framework document have helped DOE identify and resolve issues involved in the preliminary analyses. Chapter 2 of the preliminary TSD, available at the Web link provided in the SUMMARY section of this notice, summarizes and addresses the comments received in response to the framework document.

For the walk-in equipment currently under consideration, DOE conducted in-depth technical analyses in the following areas: (1) Engineering, (2) energy-use characterization, (3) markups to determine equipment price, (4) life-cycle cost and payback period, and (5) national impacts. These analyses resulted in a preliminary TSD that presents the methodology and results of each of these analyses. The preliminary TSD is available at the Web address given in the SUMMARY section of this notice. The analyses are described in more detail below.

DOE also conducted, and has included in the preliminary TSD, several other analyses that either support the five major analyses or are preliminary analyses that will be expanded in preparing the NOPR. These analyses include the market and technology assessment, the screening analysis, which contributes to the engineering analysis, and the shipments analysis, which contributes to the NIA. In addition to these analyses, DOE has begun some preliminary work on the manufacturer impact analysis and identified the methods to be used for the LCC subgroup analysis, the environmental assessment, the employment analysis, the regulatory impact analysis, and the utility impact analysis. DOE will expand on these analyses in the NOPR.

The engineering analysis establishes the relationship between the manufacturer selling price and equipment efficiency DOE is evaluating for energy conservation standards. This relationship serves as the basis for cost-benefit calculations for individual consumers, manufacturers, and the nation. The engineering analysis identifies representative baseline equipment, which is the starting point for analyzing technologies that provide energy efficiency improvements. Baseline equipment refers to a model or models having features and technologies typically found in the minimum efficiency equipment currently offered for sale. The baseline model in each equipment class represents the characteristics of certain walk-in equipment. After identifying the baseline models, DOE estimated manufacturer selling prices by using a consistent methodology and pricing scheme including material and labor costs, cost of shipping and manufacturer's markups. In this way, DOE developed these so-called “manufacturer selling prices” for the baseline and more efficient designs. Later, in its Markups To Determine Installed Price analysis, DOE converts these manufacturer selling prices into installed prices. In the preliminary TSD, section 2.4 of chapter 2 and chapter 5 each provide detail on the engineering analysis and the derivation of the manufacturer selling prices.

DOE derives the installed prices for equipment based on manufacturer markups, retailer markups, distributor markups, contractor markups, builder markups, and sales taxes. In deriving these markups, DOE has determined the distribution channels for equipment sales, the markup associated with each party in the distribution channels, and the existence and magnitude of differences between markups for baseline equipment (baseline markups) and for more-efficient equipment (incremental markups). DOE calculates both overall baseline and overall incremental markups based on the equipment markups at each step in the distribution channel. The overall incremental markup relates the change in the manufacturer sales price of higher efficiency models (the incremental cost increase) to the change in the retailer or distributor sales price. In the preliminary TSD, section 2.5 of chapter 2 and chapter 6 each provide detail on the estimation of markups.

The energy use characterization provides estimates of annual energy consumption for walk-in equipment, which DOE uses in the LCC and PBP analyses and the NIA. DOE developed energy consumption estimates for all of the equipment classes analyzed in the engineering analysis, as the basis for its energy use estimates. In the preliminary TSD, section 2.6 of chapter 2 and chapter 7 each provide detail on the energy use characterization.

The LCC and PBP analyses determine the economic impact of potential standards on individual consumers. The LCC is the total consumer expense for equipment over the life of the equipment. The LCC analysis compares the LCCs of equipment designed to meet possible energy conservation standards with the LCCs of the equipment likely to be installed in the absence of standards. DOE determines LCCs by considering (1) Total installed cost to the purchaser (which consists of manufacturer selling price, sales taxes, distribution chain markups, and installation cost); (2) the operating expenses of the equipment (energy use and maintenance); (3) equipment lifetime; and (4) a discount rate that reflects the real consumer cost of capital and puts the LCC in present-value terms. The PBP represents the number of years needed to recover the increase in purchase price (including installation cost) of more efficient equipment through savings in the operating cost of the equipment. It is the change in total installed cost due to increased efficiency divided by the change in annual operating cost from increased efficiency. In the preliminary TSD, section 2.7 of chapter 2 and chapter 8 each provide detail on the LCC and PBP analyses.

The NIA estimates the NES and the NPV of total consumer costs and savings expected to result from new standards at specific efficiency levels (referred to as candidate standard levels). DOE calculated NES and NPV for each candidate standard level for walk-in equipment as the difference between a base-case forecast (without new standards) and the standards case forecast (with standards). DOE determined national annual energy consumption by multiplying the number of units in use (by vintage) by the average unit energy consumption (also by vintage). Cumulative energy savings are the sum of the annual NES determined from 2015-2045. The national NPV is the sum over time of the discounted net savings each year, which consists of the difference between total operating cost savings and increases in total installed costs. Critical inputs to this analysis include shipments projections, retirement rates (based on estimated equipment lifetimes), and estimates of changes in shipments and retirement rates in response to changes in equipment costs due to standards. In the preliminary TSD, section 2.8 of chapter 2 and chapter 10 each provide detail on the NIA.

DOE consulted with interested parties as part of its process for conducting all of the analyses and invites further input from the public on these topics. The preliminary analytical results are subject to revision following further review and input from the public. A complete and revised TSD will be made available upon issuance of a NOPR. The final rule will contain the final analysis results and be accompanied by a final rule TSD.

DOE encourages those who wish to participate in the public meeting to obtain the preliminary TSD from DOE's website and to be prepared to discuss its contents. A copy of the preliminary TSD is available at the Web address given in the SUMMARY section of this notice. However, public meeting participants need not limit their comments to the topics identified in the preliminary TSD. DOE is also interested in receiving views concerning other relevant issues that participants believe would affect energy conservation standards for this equipment or that DOE should address in the NOPR.

Furthermore, DOE welcomes all interested parties, regardless of whether they participate in the public meeting, to submit in writing by May 20, 2010, comments and information on matters addressed in the preliminary TSD and on other matters relevant to consideration of standards for walk-in equipment.

The public meeting will be conducted in an informal, conference style. A court reporter will be present to record the minutes of the meeting. There shall be no discussion of proprietary information, costs or prices, market shares, or other commercial matters regulated by United States antitrust laws.

After the public meeting and the expiration of the period for submitting written statements, DOE will consider all comments and additional information that is obtained from interested parties or through further analyses, and it will prepare a NOPR. The NOPR will include proposed energy conservation standards for the equipment covered by the rulemaking, and members of the public will be given an opportunity to submit written and oral comments on the proposed standards.

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2010-0308; Directorate Identifier 2010-NE-17-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

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

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued AD 2010-0020, dated February 8, 2010 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

TAE has issued Service Bulletin No. TM TAE 125-0019, Revision 1, dated March 5, 2009. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the aviation authority of Germany and is approved for operation in the United States. Pursuant to our bilateral agreement with Germany, EASA has notified us of the unsafe condition described in the MCAI. We are proposing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design. This proposed AD would require removing from service certain part number blow-by oil separators, within the next 110 flight hours after the effective date of the proposed AD.

Based on the service information, we estimate that this proposed AD would affect about 250 engines installed on airplanes of U.S. registry. We also estimate that it would take about 1.5 work-hours per engine to comply with this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $1,500 per engine. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $406,875.

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

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

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

For the reasons discussed above, I certify this proposed regulation:

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

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

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

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

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

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2010-0276; Directorate Identifier 2009-NM-144-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

We have lengthened the 30-day comment period for proposed ADs that address MCAI originated by aviation authorities of other countries to provide adequate time for interested parties to submit comments. The comment period for these proposed ADs is now typically 45 days, which is consistent with the comment period for domestic transport ADs.

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

On October 18, 2004, we issued AD 2004-22-08, Amendment 39-13836 (69 FR 62807, October 28, 2004). That AD required actions intended to address an unsafe condition on the products listed above.

Since we issued AD 2004-22-08, Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2009-31, dated July 8, 2009 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

Bombardier has issued Temporary Revision (TR) 1-2-39, dated December 12, 2008, to Section 2—Systems and Powerplant Program, of Part 1 of the Bombardier CL-600-2B19 Maintenance Requirements Manual (MRM) CSP A-053. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

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

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

We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a Note within the proposed AD.

This proposed AD would retain certain requirements of AD 2004-22-08. Since AD 2004-22-08 was issued, the AD format has been revised, and certain paragraphs have been rearranged. As a result, the corresponding paragraph identifiers have changed in this proposed AD, as listed in the following table:

We have removed the service bulletin definition paragraph from the restated requirements of AD 2004-22-08. (That paragraph was identified as paragraph (a)(1) in AD 2004-22-08.) Instead, we have provided the full service bulletin citations throughout this NPRM.

Based on the service information, we estimate that this proposed AD would affect about 644 products of U.S. registry.

The actions that are required by AD 2004-22-08 and retained in this proposed AD take about 15 work-hours per product, at an average labor rate of $85 per work hour. Required parts cost about $0 per product. Based on these figures, the estimated cost of the currently required actions is $1,869 per product.

We estimate that it would take about 1 work-hour per product to comply with the new requirement to revise the ALI. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this requirement of the proposed AD on U.S. operators to be $54,740, or $85 per product.

We estimate that it would take about 5 work-hours per product to comply with the new inspection requirement. The average labor rate is $85 per work-hour. Required parts would cost about $594 per product, per replacement cycle. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these costs. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of the inspection requirements of the proposed AD on U.S. operators to be $656,236, or $1,019 per product, per replacement cycle.

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

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

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

For the reasons discussed above, I certify this proposed regulation:

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

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

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

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

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

The COPPA Rule, issued pursuant to the Children’s Online Privacy Protection Act, 15 U.S.C. § 6501, et seq., became effective on April 21, 2000. The Rule imposes certain requirements on operators of websites or online services directed to children under 13 years of age, and on operators of other websites or online services that have actual knowledge that they are collecting personal information online from a child under 13 years of age (collectively, “operators”).1 Among other things, the Rule requires that operators provide notice to parents and obtain verifiable parental consent prior to collecting, using, or disclosing personal information from children under 13 years of age. The Rule also requires operators to keep secure the information they collect from children and prohibits them from conditioning children’s participation in activities on the collection of more personal information than is reasonably necessary to participate in such activities. Further, the Rule contains a “safe harbor” provision enabling industry groups or others to submit to the Commission for approval self-regulatory guidelines that would implement the Rule’s protections.2

COPPA and § 312.11 of the Rule required the Commission to initiate a review no later than five years after the Rule’s effective date to evaluate the Rule’s implementation. The Commission commenced this mandatory review on April 21, 2005. After receiving and considering extensive public comment on the Rule, the Commission determined in March 2006 to retain the COPPA Rule without change.3 However, the Commission believes that changes to the online environment over the past five years, including but not limited to children’s increasing use of mobile technology to access the Internet, warrant reexamining the Rule at this time.

In this notice, the Commission poses its standard regulatory review questions to determine whether the Rule should be retained, eliminated, or modified. In addition, the Commission identifies several areas where public comment would be especially useful. First, the Commission asks whether the Rule’s current definitions are sufficiently clear and comprehensive, or whether they might warrant modification or expansion, consistent with the COPPA statute. Among other questions, the Commission asks for comment on the application of the definition of “Internet” to mobile communications, interactive television, interactive gaming, and similar activities. Further, the Commission asks whether the Rule’s definition of “personal information” should be expanded to include other items of information that can be collected from children online and are not currently specified in the Rule, such as persistent IP addresses, mobile geolocation information, or information collected in connection with online behavioral advertising.

The Commission also seeks comment on the use of automated systems for reviewing children’s web submissions (e.g., those that filter out any personally identifiable information prior to posting). In addition, the Commission asks whether change is warranted as to the Rule provisions on protecting the confidentiality and security of personal information, the right of parents to review or delete personal information, and the prohibition against conditioning a child’s participation on the collection of personal information. Finally, the Commission seeks comment about its role in administering the Rule’s safe harbor provisions.

The Commission invites members of the public to comment on any issues or concerns they believe are relevant or appropriate to the Commission’s review of the COPPA Rule, and to submit written data, views, facts, and arguments addressing the Rule. All comments should be filed as prescribed in the Invitation To Comment part of the “SUPPLEMENTARY INFORMATION” section below, and must be received by June 30, 2010. The Commission is particularly interested in comments addressing the following questions:

1. Is there a continuing need for the Rule as currently promulgated? Why or why not?

a. Since the Rule was issued, have changes in technology, industry, or economic conditions affected the need for or effectiveness of the Rule?

b. What are the aggregate costs and benefits of the Rule?

c. Does the Rule include any provisions not mandated by the Act that are unnecessary or whose costs outweigh their benefits? If so, which ones and why?

2. What effect, if any, has the Rule had on children, parents, or other consumers?

a. Has the Rule benefitted children, parents, or other consumers? If so, how?

b. Has the Rule imposed any costs on children, parents, or other consumers? If so, what are these costs?

c. What changes, if any, should be made to the Rule to increase its benefits, consistent with the Act’s requirements? What costs would these changes impose?

3. What impact, if any, has the Rule had on operators?

a. Has the Rule provided benefits to operators? If so, what are these benefits?

b. Has the Rule imposed costs on operators, including costs of compliance in time or monetary expenditures? If so, what are these costs?

c. What changes, if any, should be made to the Rule to reduce the costs imposed on operators, consistent with the Act’s requirements? How would these changes affect the Rule’s benefits?

4. How many small businesses are subject to the Rule? What costs (types and amounts) do small businesses incur in complying with the Rule? How has the Rule otherwise affected operators that are small businesses? Have the costs or benefits of the Rule changed over time with respect to small businesses? What regulatory alternatives, if any, would decrease the Rule’s burden on small businesses, consistent with the Act’s requirements?

5. Does the Rule overlap or conflict with any other federal, state, or local government laws or regulations? How should these overlaps or conflicts be resolved, consistent with the Act’s requirements?

a. Are there any unnecessary regulatory burdens created by overlapping jurisdiction? If so, what can be done to ease the burdens, consistent with the Act’s requirements?

b. Are there any gaps where no federal, state, or local government law or regulation has addressed a problematic practice relating to children’s online privacy? Could or should any such gaps be remedied by a modification to the Rule?

6. Do the definitions set forth in § 312.2 of the Rule accomplish COPPA’s goal of protecting children’s online privacy and safety?

7. Are the definitions in § 312.2 clear and appropriate? If not, how can they be improved, consistent with the Act’s requirements?

8. Should the definitions of “collects or collection” and/or “disclosure” be modified in any way to take into account online technologies and/or Internet activities and features that have emerged since the Rule was enacted or that may emerge in the future? For instance, how will the use of centralized authentication methods (e.g., OpenId) affect individual websites’ COPPA compliance efforts?

9. The Rule considers personal information to have been “collected” where an operator enables children to make personal information publicly available through a chat room, message board, or other means, except where the operator “deletes” all individually identifiable information from postings by children before they are made public and deletes such information from the operator’s records.

a. Are there circumstances in which an operator using an automated system of review and/or posting meets the deletion exception to the definition of collection?

b. Does the Rule’s current definition of “delete” provide sufficient guidance to operators about how to handle the removal of personal information?

10. Should the definition of “collection” be modified or clarified to include other means of collection of personal information from children that are not specifically enumerated in the Rule’s current definition?

11. What are the implications for COPPA enforcement raised by technologies such as mobile communications, interactive television, interactive gaming, or other similar interactive media, consistent with the Act’s definition of “Internet”?

12. The Rule defines “personal information” as individually identifiable information about an individual collected online, and enumerates such items of information. Do the items currently enumerated as “personal information” need to be clarified or modified in any way, consistent with the Act?

13. Section 1302(8)(F) of the Act provides the Commission with discretion to include in the definition of “personal information” any identifier that it determines would permit the physical or online contacting of a specific individual.

a. Do operators, including network advertising companies, have the ability to contact a specific individual, either physically or online, using one or more pieces of information collected from children online, such as user or screen names and/or passwords, zip code, date of birth, gender, persistent IP addresses, mobile geolocation information, information collected in connection with online behavioral advertising, or other emerging categories of information? Are operators using such information to contact specific individuals?

b. Should the definition of “personal information” in the Rule be expanded to include any such information?

14. Are providers of downloadable software collecting information from children that permits the physical or online contacting of a specific individual?

15. Should the Rule define “the physical or online contacting of a specific individual,” “website,” “online service,” or any other term not currently defined? If so, how should such terms be defined, consistent with the Act’s requirements?

16. Section 312.4 of the Rule sets out the requirements for the content and delivery of operators’ notices of their information practices with regard to children.

a. Are the requirements in this Part clear and appropriate? If not, how can they be improved?

b. Should the notice requirements be clarified or modified in any way to reflect changes in the types or uses of children’s information collected by operators or changes in communications options available between operators and parents?

17. Section 312.5 of the Rule requires operators to obtain verifiable parental consent before collecting, using, and/or disclosing personal information from children, including consent to any material change to practices to which the parent previously consented. This Part further requires operators to make reasonable efforts to obtain this consent, which efforts are reasonably calculated to ensure that the person providing consent is the child’s parent, taking into consideration available technology.

a. Has the consent requirement been effective in protecting children’s online privacy and safety?

b. What data exists on: (1) operators’ use of parental consent mechanisms; (2) parents’ awareness of the Rule’s parental consent requirements; or (3) parents’ response to operators’ parental consent requests?

18. Section 312.5(b)(2) of the Rule provides a non-exhaustive list of approved methods to obtain verifiable parental consent, including: providing a consent form to be signed by the parent and returned to the operator; requiring a parent to use a credit card in connection with a transaction; having a parent call a toll-free number staffed by trained personnel; using a digital certificate that uses public key technology; and using email accompanied by a PIN/password obtained through one of the other enumerated verification methods.

a. To what extent are operators using each of the enumerated methods? Please provide as much specific data as possible, including the costs and benefits associated with each method described.

b. Are there additional methods to obtain verifiable parental consent, based on current or emerging technological changes, that should be added to § 312.5 of the Rule? What are the costs and benefits of these additional methods?

c. Should any of the currently enumerated methods to obtain verifiable parental consent be removed from the Rule? If so, please explain which one(s) and why.

d. Are there methods for delivering a signed consent form, other than postal mail or facsimile, that would meet the Rule’s standards for verifiable parental consent? Should these be specified in the Rule?

e. Are there current or emerging forms of payment, other than the use of a credit card in connection with a transaction, that would meet the Rule’s standards for verifiable parental consent? Should these be specified in the Rule?

f. The Rule permits use of a credit card in connection with a transaction to serve as a form of verifiable parental consent. Is there data available on the proliferation of credit cards, debit cards, or gift cards among children under 13 years of age? What challenges, if any, does children’s use of credit, debit, and/or gift cards pose for Rule compliance or enforcement?

g. Are there current or emerging forms of oral communication, other than the use of a toll-free telephone number staffed by trained personnel, that would meet the Rule’s standards for verifiable parental consent? Should these be specified in the Rule?

19. Section 312.5(b)(2) also sets forth a mechanism that operators can use to obtain verifiable parental consent for uses of information other than “disclosures” (the “email plus mechanism”). The email plus mechanism permits the use of an email coupled with additional steps to provide assurances that the person providing consent is the parent, including sending a confirmatory email to the parent following receipt of consent or obtaining a postal address or telephone number from the parent and confirming the parent’s consent by letter or telephone call. In 2006, the Commission announced that it would retain the email plus mechanism indefinitely. See (http://www.ftc.gov/os/fedreg/2006/march/060315childrens-online-privacy-rule.pdf).

a. Does the email plus mechanism remain a viable form of verifiable parental consent for operators’ internal uses of information?

b. Are there other current or emerging forms of communications, not enumerated in § 312.5(b)(2), that would meet the Rule’s standards for verifiable parental consent for operators’ internal uses of information? Are any changes or modifications to this Part warranted?

20. COPPA and § 312.5(c) of the Rule set forth five exceptions to the prior parental consent requirement. Are the exceptions in § 312.5(c) clear? If not, how can they be improved, consistent with the Act’s requirements?

21. Section 312.5(c)(3) of the Rule requires that operators who collect children’s online contact information for the sole purpose of communicating directly with a child after the child has specifically requested such communication must provide parents with notice and the opportunity to opt-out of the operator’s further use of the information (the “multiple contact” exception).

a. To what extent are operators using the multiple contact exception to communicate or engage with children on an ongoing basis? Are operators relying on the multiple contact exception to collect more than just online contact information from children?

b. Should the multiple contact exception be clarified or modified in any way, consistent with the Act’s requirements, to take into account any changes in the manner in which operators communicate or engage with children?

c. Under this Part, acceptable notice mechanisms include sending the opt-out notice by postal mail or to the parent’s email address. Should § 312.5(c)(3) be modified to remove postal mail as a means of delivering an opt-out notice to parents?

d. Should § 312.5(c)(3) be otherwise clarified or modified in any way to reflect current or emerging technological changes that have or may expand options for the online contacting of children or options for communications between operators and parents?

22. Section 312.5(c)(4) of the Rule requires an operator who collects a child’s name and online contact information to the extent reasonably necessary to protect the safety of a child participant in the website or online service to use reasonable efforts to provide a parent notice and the opportunity to opt-out of the operator’s use of such information. Such information must only be used to protect the child’s safety, cannot be used to re-contact the child or any other purpose, and may not be disclosed.

a. To what extent, and under what circumstances, do operators use § 312.5(c)(4) to protect children’s safety?

b. Are the requirements of § 312.5(c)(4) clear and appropriate? If not, how can they be improved, consistent with the Act’s requirements?

23. Section 312.5(c)(5) of the Rule permits operators to collect a child’s name and online contact information to protect the security or integrity of the site, take precautions against liability, respond to judicial process, or to provide information to law enforcement agencies or in connection with a public safety investigation.

a. To what extent, and under what circumstances, do operators use § 312.5(c)(5)?

b. Are the requirements of § 312.5(c)(5) clear and appropriate? If not, how can they be improved, consistent with the Act’s requirements? For example, should § 312.5(c)(5) of the Rule be clarified to allow operators to collect and maintain a child’s name and/or online contact information for the purpose of preventing future attempts at registration?

24. Section 312.6(a) of the Rule requires operators to give parents, upon their request: (1) a description of the specific types of personal information collected from children; (2) the opportunity to refuse to permit the further use or collection of personal information from the child and to direct the deletion of the information; and (3) a means of reviewing any personal information collected from the child. In the case of a parent who wishes to review the personal information collected from the child, § 312.6(a)(3) of the Rule requires operators to provide a means of review that ensures that the requestor is a parent of that child (taking into account available technology) and is not unduly burdensome to the parent.

a. To what extent are parents exercising their rights under § 312.6(a)(1) to obtain from operators a description of the specific types of personal information collected from children?

b. To what extent are parents exercising their rights under § 312.6(a)(2) to refuse to permit the further use or collection of personal information from the child and to direct the deletion of the information?

c. To what extent are parents exercising their rights under § 312.(a)(3) to review any personal information collected from the child?

d. Do the costs and burdens to operators or parents differ depending on whether a parent seeks a description of the information collected, access to the child’s information, or to have the child’s information deleted?

e. Is it difficult for operators to ensure, taking into account available technology, that a requester seeking to review the personal information collected from a child is a parent of that child?

f. Should § 312.6(a)(3) enumerate the methods an operator may use to ensure that a requestor seeking to review the personal information collected from a child is a parent of that child? Should these methods be consistent with the verification methods enumerated currently or in the future in § 312.5(b)(2) of the Rule?

g. Are the requirements of § 312.6 clear and appropriate? If not, how can they be improved, consistent with the Act’s requirements?

25. COPPA and § 312.7 of the Rule prohibit operators from conditioning a child’s participation in an activity on disclosing more personal information than is reasonably necessary to participate in such activity.

a. Do operators take this requirement into account when shaping their online offerings to children?

b. Has the prohibition been effective in protecting children’s online privacy and safety?

c. Is § 312.7 of the Rule clear and adequate? If not, how could it be improved, consistent with the Act’s requirements?

26. Section 312.8 of the Rule requires operators to establish and maintain reasonable procedures to protect the confidentiality, security, and integrity of personal information collected from a child.

a. Have operators implemented sufficient safeguards to protect the confidentiality, security, and integrity of personal information collected from a child?

b. Is § 312.8 of the Rule clear and adequate? If not, how could it be improved, consistent with the Act’s requirements?

27. Section 312.10 of the Rule provides that an operator will be deemed in compliance with the Rule’s requirements if the operator complies with Commission-approved self-regulatory guidelines (the “safe harbor” process).

a. Has the safe harbor process been effective in enhancing compliance with the Rule?

b. Should the criteria for Commission approval of a safe harbor program be modified in any way to strengthen the standards currently enumerated in § 312.10(b)?

c. Should § 312.10 be modified to include a requirement that approved safe harbor programs undergo periodic reassessment by the Commission? If so, how often should such assessments be required?

d. Should § 312.10(b)(4) of the Rule, regarding the Commission’s discretion to initiate an investigation or bring an enforcement action against an operator participating in a safe harbor program, be clarified or modified in any way?

e. Should any other changes be made to the criteria for approval of self-regulatory guidelines, or to the safe harbor process, consistent with the Act’s requirements?

28. Does the commenter propose any modifications to the Rule that may conflict with the statutory provisions of the COPPA Act? For any such proposed modification, does the commenter propose seeking legislative changes to the Act?

All persons are hereby given notice of the opportunity to submit written data, views, facts, and arguments pertinent to this rule review. Written comments must be received on or before June 30, 2010, and may be submitted electronically or in paper form. Comments should refer to “COPPA Rule Review, P104503” to facilitate the organization of comments. Please note that your comment - including your name and your state - will be placed on the public record of this proceeding, including on the publicly accessible FTC website, at (http://www.ftc.gov/os/publiccomments.shtm).

Because comments will be made public, they should not include any sensitive personal information, such as any individual’s Social Security number; date of birth; driver’s license number or other state identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. Comments also should not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, comments should not include any “[t]rade secret or any commercial or financial information which is obtained from any person and which is privileged or confidential. . . ,” as provided in Section 6(f) of the Federal Trade Commission Act (“FTC Act”), 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c), 16 CFR 4.9(c).4

Because paper mail addressed to the FTC is subject to delay due to heightened security screening, please consider submitting your comments in electronic form. Comments filed in electronic form should be submitted by using the following weblink: (https://public.commentworks.com/ftc/2010copparulereview) (and following the instructions on the web-based form). To ensure that the Commission considers an electronic comment, you must file it at (https://public.commentworks.com/ftc/2010copparulereview). If this document appears at (http://www.regulations.gov/search/Regs/home.html#home), you may also file an electronic comment through that website. The Commission will consider all comments that regulations.gov forwards to it. You may also visit the FTC website at (http://www.ftc.gov) to read the document and the news release describing it.

A comment filed in paper form should include the “COPPA Rule Review, P104503” reference both in the text and on the envelope, and should be mailed or delivered to the following address: Federal Trade Commission, Office of the Secretary, Room H-135 (Annex E), 600 Pennsylvania Avenue, NW, Washington, DC 20580. The FTC is requesting that any comment filed in paper form be sent by courier or overnight service, if possible, because U.S. postal mail in the Washington area and at the Commission is subject to delay due to heightened security precautions.

The FTC Act and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives, whether filed in paper or electronic form. Comments received will be available to the public on the FTC website, to the extent practicable, at (http://www.ftc.gov/os/publiccomments.shtm). As a matter of discretion, the Commission makes every effort to remove home contact information for individuals from the public comments it receives before placing those comments on the FTC website. More information, including routine uses permitted by the Privacy Act may be found in the FTC’s privacy policy, at (http://www.ftc.gov/ftc/privacy.shtm).

Written communications and summaries of transcripts of oral communications respecting the merits of this proceeding from any outside party to any Commissioner or Commissioner’s advisor will be placed on the public record.5

The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq.), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the Safe Medical Device Amendments (SMDA) (Public Law 101-629), and the Food and Drug Administration Modernization Act (FDAMA) (Public Law 105-115) established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Most generic types of devices that were on the market before the date of the 1976 amendments (May 28, 1976) (generally referred to as preamendments devices) have been classified by FDA under the procedures set forth in section 513(c) and (d) of the act through the issuance of classification regulations into one of these three regulatory classes. Devices introduced into interstate commerce for the first time on or after May 28, 1976 (generally referred to as postamendments devices) are classified automatically by statute (section 513(f) of the act) into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless FDA initiates the following procedures: (1) FDA reclassifies the device into class I or II; (2) FDA issues an order classifying the device into class I or II in accordance with section 513(f)(2) of the act; or (3) FDA issues an order finding the device to be substantially equivalent, under section 513(i) of the act, to a predicate device that is already legally marketed. The agency determines whether new devices are substantially equivalent to predicate devices through review of premarket notifications under section 510(k) of the act (21 U.S.C. 360(k)). Section 510(k) of the act and the implementing regulations, part 807 (21 CFR part 807), require persons who intend to market a new device to submit a premarket notification report (510(k)) containing information that allows FDA to determine whether the new device is “substantially equivalent” within the meaning of section 513(i) of the act to a legally marketed device that does not require premarket approval.

Section 510(m)(2) of the act provides that FDA may exempt a device from the premarket notification requirement on its own initiative or upon petition of an interested person, if FDA determines that a 510(k) is not necessary to provide reasonable assurance of the safety and effectiveness of the device. This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 30-day comment period. Within 120 days of publication of this document, FDA must publish in the Federal Register its final determination regarding the exemption of the device that was the subject of the notice.

Under section 513(a)(1)(B) of the act, as amended by SMDA, class II devices are defined as devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance. Special controls may include the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions the agency deems necessary to provide such assurance (21 CFR 860.3(c)(2)).

Consistent with this authority, FDA is proposing to amend the neurological devices regulations to establish special controls for electroconductive media (§ 882.1275 (21 CFR 882.1275)) and the cutaneous electrode (§ 882.1320 (21 CFR 882.1320)). FDA is also proposing to amend the neurological devices regulation at § 882.5890 (21 CFR 882.5890) to add paragraphs for the transcutaneous electrical nerve stimulator for pain relief (§ 882.5890(a)), the transcutaneous electrical nerve stimulator for pain relief intended for over the counter use (§ 882.5890(b)), the transcutaneous electrical nerve stimulator with limited output for pain relief (§ 882.5890(c)), the percutaneous electrical nerve stimulator for pain relief (§ 882.5890(d)), the transcutaneous electrical stimulator for aesthetic purposes (§ 882.5890(e)), and the transcutaneous electrical stimulator with limited output for aesthetic purposes (§ 882.5890(f)).

Similarly, FDA is proposing to amend the physical medicine devices regulation at § 890.5850 (21 CFR 890.5850) to add paragraphs for the powered muscle stimulator for rehabilitation (§ 890.5850(a)), the powered muscle stimulator with limited output for rehabilitation (§ 890.5850(b)), the powered muscle stimulator for muscle conditioning (§ 890.5850(c)), and the powered muscle stimulator with limited output for muscle conditioning (§ 890.5850(d)). FDA believes that subdividing the classification regulations for each of these device types would provide clarity for persons referencing the classification regulation.

FDA is also proposing to establish special controls for each of these device types. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of the following draft guidance documents that would serve as special controls:

(1) Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Electroconductive Media;

(2) Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Cutaneous Electrode;

(3) Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief;

(4) Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use;

(5) Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator with Limited Output for Pain Relief;

(6) Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator for Aesthetic Purposes;

(7) Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator with Limited Output for Aesthetic Purposes;

(8) Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Powered Muscle Stimulator for Rehabilitation;

(9) Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Rehabilitation;

(10) Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning; and

(11) Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning.

Together with the establishment of special controls, FDA, on its own initiative, is also proposing to exempt some of these device types from premarket notification, subject to limitations. FDA may consider a number of factors in determining whether premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the guidance the agency issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff.” The guidance can be obtained electronically at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080198.htm.

FDA believes that the following class II devices are appropriate for exemption from premarket notification, subject to the limitations of exemptions identified in §§ 882.9 and 890.9 (21 CFR 882.9 and 890.9), because the applicable special controls and general controls provide reasonable assurance of safety and effectiveness if device manufacturers follow the special controls guidances' recommendations and, for the transcutaneous electrical nerve stimulator with limited output for pain relief and the powered muscle stimulator with limited output for rehabilitation, if the devices are also restricted to sale, distribution, and use in accordance with the prescription device requirements in § 801.109 (21 CFR 801.109):

• Electroconductive media (§ 882.1275);

• Cutaneous electrode (§ 882.1320);

• Transcutaneous electrical nerve stimulator with limited output for pain relief (§ 882.5890(c));

• Transcutaneous electrical stimulator with limited output for aesthetic purposes (§ 882.5890(e));

• Powered muscle stimulator with limited output for rehabilitation (§ 890.5850(b)); and

• Powered muscle stimulator with limited output for muscle conditioning (§ 890.5850(d)).

FDA advises that exemption from the requirement of premarket notification does not mean that these devices would be exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. Indeed, FDA's proposal to exempt these device types from the requirement of premarket notification is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements (21 CFR part 820), provide.

FDA proposes that any final rule that may issue based on this proposal become effective 30 days after its date of publication in the Federal Register. If finalized, following the effective date of a final rule, any firm intending to market the applicable device types will need to address the issues covered in the respective special controls guidances. Unless otherwise exempt, the firm must show in its 510(k) that its device meets the requirements of § 807.87 and complies with the special controls.

As discussed previously in this document, if the rule is finalized, for six of the device types, manufacturers who follow the specific measures recommended to address the issues identified in the special controls guidances would be able to market their devices without being subject to the premarket notification requirements of section 510(k) of the act, subject to the limitations of §§ 882.9 and 890.9. Manufacturers of two of these six device types, transcutaneous electrical nerve stimulator with limited output for pain relief and powered muscle stimulator with limited output for rehabilitation, would also be restricted to sale, distribution, and use in accordance with the prescription device requirements in § 801.109 in order to be able to market their devices without being subject to premarket notification. Manufacturers who choose alternative means to address one or more of the issues identified in the applicable special controls guidance would remain subject to the premarket notification requirements of section 510(k) and would need to obtain marketing clearance for their device.

The agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Classification of the devices discussed in this proposed rule into class II with special controls will simplify the process of bringing these devices to market. In addition, exemption from the premarket notification requirements for six of these devices would reduce the costs associated with bringing the devices to market. Thus, the agency proposes to certify that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $133 million, using the most current (2008) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this proposed rule to result in any 1-year expenditure that would meet or exceed this amount.

The special controls required by this proposed rule for the 11 listed devices do not impose significant costs because they do not add new regulatory requirements. Instead, the special controls clarify FDA expectations and should shorten the time to market for some new or modified devices. Manufacturers of devices exempt from the premarket notification requirements would no longer have to wait until they receive a substantial equivalence determination from FDA before marketing the device. For manufacturers of devices that still require premarket notification, the special controls clarify FDA's expectations making compliance with the general and special controls more straightforward and should shorten the time to prepare a submission and for FDA review. Moreover, manufacturers of devices that become exempt from the premarket notification requirement would also benefit from the elimination of application preparation time and of paper, copying, and mailing costs by not having to prepare and submit 510(k)s. These application savings are negligible, however, relative to the total cost of bringing a medical device to market.

The sector of the device industry covered by the proposed rule is part of the Electromedical and Electrotherapeutic Apparatus Manufacturing sector, NAICS code 334510. The Small Business Administration classifies firms in this sector as small if they have fewer than 500 employees. About 90 percent of firms in this sector are small, employing about 25 percent of the sector's work force. Table 1 lists the number of manufacturers for the different types of devices, an estimate of the number of 510(k)s submitted each year (based on historical ranges), and our best estimate of the percentage of new devices that would be exempt from the premarket notification requirement for each type of device.

The potential impact on small firms would be to reduce the cost of entry by shortening the time to market for those firms who plan to market these devices. It will impose no additional regulatory burden on small entities, and it may permit some small potential competitors to enter the marketplace by lowering their costs. Therefore the agency proposes to certify that the final rule will not have a significant economic impact on a substantial number of small entities.

FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State law conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts certain state requirements “different from or in addition to” certain federal requirements applicable to devices (21 U.S.C. 360k; See Medtronic v. Lohr, 518 U.S. 470 (1996); Riegel v. Medtronic, 128 S. Ct. 999 (2008)). If this proposed rule is made final, the special controls established by the final rule would create “requirements” for specific medical devices under 21 U.S.C. 360k, even though product sponsors have some flexibility in how they meet those requirements (Papike v. Tambrands, Inc., 107 F.3d 737, 740-742 (9th Cir. 1997)).

FDA tentatively concludes that this proposed rule contains no new collection of information; however, consistent with the regulatory impact analysis in section V of this document, we anticipate that the exemption of 6 devices types from the premarket notification requirements of the act will result in a reduction in burden to existing collections of information currently approved under OMB control number 0910-0120.

Accordingly, with respect to the collection of information discussed below, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

This proposed rule designates guidance documents and other special controls for certain neurological and physical medicine devices and exempts certain of these devices from premarket notification requirements. FDA expects an overall reduction in burden hours for manufacturers of the six device types that FDA is proposing to exempt from the premarket notification reporting requirements. The current burden associated with submitting a premarket notification submission under part 807, subpart E is 79 hours per submission at a cost of $100 per hour resulting in a total cost of $7,900 per submission. As identified elsewhere in this document, the six device types being exempted from the premarket notification requirements of the act will no longer be subject to this burden. Based on FDA's estimates of annual premarket notifications submitted for the exempted device types (table 2 of this document), FDA estimates a total burden reduction of 34.25 annual premarket notification submissions (90% of 2.5)+(90% of 10)+(60% of 20)+(60% of 2.5)+(50% of 15)+(50% of 4)), 2,706 hours (34.25 submissions x 79 hours), and $270,600 (2,706 hours x $100 hourly rate).

The guidance documents designated as special controls for each of these 11 device types do not impose significant costs because they do not add new regulatory requirements. Instead, the special controls clarify FDA expectations and should shorten the time to market for some new or modified devices. For manufacturers of devices that still require premarket notification, the special controls clarify FDA's expectations making compliance with the general and special controls more straightforward and should shorten the time to prepare a submission and for FDA review. While this clarification in expectations may reduce the actual burden associated with submitting a premarket notification submission for these specific device types, this reduction is negligible when accounting for the size of entire premarket notification program. Accordingly, FDA will not be adjusting the per submission burden estimate of 79 hours for premarket notification submissions accounted for under OMB control number 0910-0120.

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

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR parts 882 and 890 be amended as follows:

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-2010-0180), 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 deliver, 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 e-mail 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-2010-0180” 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 81/2 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-2010-0180 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 for one 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.

Marine events are frequently held on the navigable waters within the boundary of Fifth Coast Guard District. The water activities that typically comprise marine events include sailing regattas, powerboat races, swim races and holiday parades. For a description of the geographical area of the Coast Guard Sector Hampton Roads Captain of the Port Zone, please see 33 CFR 3.25-10.

This regulation proposes to temporarily change the enforcement period of special local regulations for recurring marine events within Fifth Coast Guard District. This proposed regulation applies to one marine event in 33 CFR 100.501, Table to § 100.501.

On July 9, 10, and 11, 2010, the City of Hampton and The Virginia Air and Space Museum will sponsor the “11th Hampton Blackbeard Festival,” a historic festival on the waters of the Hampton River near Hampton, Virginia. The regulation at 33 CFR 100.501 is effective annually for this marine event. The event will consist of three replica pirate ships conducting a simulated wartime demonstration on July 10, 2010 from 11:30 a.m. to 2:30 p.m. and July 11, 2010 from 12:30 p.m. to 1:30 p.m. on the Hampton River in the vicinity of Mill Point Park, Hampton, Virginia. The event will also consist of a fireworks display on July 10, 2010 from 9 p.m to 10 p.m over the Hampton River in the vicinity of Mill Point Park, Hampton, Virginia. A fleet of spectator vessels is expected to gather near the event site to view the simulated wartime demonstration and fireworks display. To provide for the safety of participants, spectators, support and transiting vessels, the Coast Guard will temporarily restrict vessel traffic in the event area during the demonstration and fireworks display. The regulation at 33 CFR 100.501 would be enforced for the duration of the event. Under provisions of 33 CFR 100.501, from 11:30 a.m. to 2:30 p.m. and 9 p.m. to 10 p.m. on July 10, 2010, and from 12:30 p.m. to 1:30 p.m. on July 11, 2010, vessels may not enter the regulated area unless they receive permission from the Coast Guard Patrol Commander.

The Coast Guard proposes to temporarily suspend the regulations at 33 CFR 100.501 by changing the date of enforcement in the table to § 100.501. The Coast Guard proposes to temporarily change the enforcement period of special local regulations for recurring marine events within Fifth Coast Guard District. This regulation applies to only one marine event listed as number 36 in the Table to § 100.501.

The Table to § 100.501, event No. 36 establishes the enforcement date for the “11th Hampton Blackbeard Festival”. This regulation proposes to temporarily change the enforcement date from “May—last Friday, Saturday and Sunday or June—1st Friday, Saturday, and Sunday” to the second Friday, Saturday and Sunday in July, holding the event on July 9, 10, and 11, 2010. The temporary special local regulations will be enforced from 11:30 a.m. to 2:30 p.m. and 9 p.m. to 10 p.m. on July 10, 2010, and from 12:30 p.m. to 1:30 p.m. on July 11, 2010 and will restrict general navigation in the regulated area during the event. The City of Hampton and The Virginia Air and Space Museum which is the sponsor for this event intends to hold this event annually; however, they have requested to change the date of the event for 2010 so that it is outside the scope of the existing enforcement period. Except for participants and vessels authorized by the Coast Guard Patrol Commander, no person or vessel will be allowed to enter or remain in the regulated area. These regulations are needed to control vessel traffic during the event to enhance the safety of participants, spectators and transiting vessels.

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, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

Although this proposed rule prevents traffic from transiting a portion of certain waterways during specified events, the effect of this regulation will not be significant due to the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via marine information broadcasts, local radio stations and area newspapers so mariners can adjust their plans accordingly. Additionally, this rulemaking does not change the permanent regulated area that was published in 33 CFR 100.501, Table to § 100.501. In some cases vessel traffic may be able to transit the regulated area when the Coast Guard Patrol Commander deems it is safe to do so.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this 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 rule would affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in the areas where marine events are being held. This regulation will not have a significant impact on a substantial number of small entities because it will be enforced only during marine events that have been permitted by the Coast Guard Captain of the Port. The Captain of the Port will ensure that small entities are able to operate in the areas where events are occurring when it is safe to do so. In some cases, vessels will be able to safely transit around the regulated area at various times, and, with the permission of the Patrol Commander, vessels may transit through the regulated area. Before the enforcement period, the Coast Guard will issue maritime advisories so mariners can adjust their plans accordingly.

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.

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 they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the Sector Hampton Roads Project Officer listed under FOR FURTHER INFORMATION CONTACT at the beginning of this rule. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

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

This 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 which do not individually or cumulatively have a significant effect on the human environment. This rule involves implementation of regulations within 33 CFR Part 100 that apply to organized marine events on the navigable waters of the United States that may have potential for negative impact on the safety or other interest of waterway users and shore side activities in the event area. The category of water activities includes but is not limited to sail boat regattas, boat parades, power boat racing, swimming events, crew racing, and sail board racing. Under figure 2-1, paragraph (34)(h), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule. 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 100 as follows:

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-2010-0113), 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 delivery, 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 e-mail 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-2010-0113” 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 81/2 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-2010-0113 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 for one 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.

Marine events are frequently held on the navigable waters within the boundary of the Fifth Coast Guard District. The on water activities that typically comprise marine events include sailing regattas, power boat races, swim races and holiday parades. For a description of the geographical area of each Coast Guard Sector—Captain of the Port Zone, please see 33 CFR 3.25.

This regulation proposes to temporarily change the enforcement period of special local regulations for recurring marine events within the Fifth Coast Guard District. This proposed regulation applies to one marine event previously published at 33 CFR 100.501, Table to § 100.501.

Annually, the District of Columbia Aquatics Club sponsors the “Maryland Swim for Life”, on the waters of the Chester River near Chestertown, MD. The regulation at 33 CFR 100.501 is effective annually for the Maryland Swim for Life marine event. The event is an open water swimming competition held on the waters of the Chester River, near Chestertown, Maryland. Approximately 150 swimmers will start from Rolph's Wharf and swim up-river 2.5 miles then swim down-river returning back to Rolph's Wharf. A large fleet of support vessels accompany the swimmers. Therefore, to ensure the safety of participants and support vessels, 33 CFR 100.501 would be enforced for the duration of the event. Under provisions of 33 CFR 100.501, from 5:30 a.m. to 2:30 p.m. on July 10, 2010, vessels may not enter the regulated area unless they receive permission from the Coast Guard Patrol Commander. Vessel traffic may be allowed to transit the regulated area only when the Patrol Commander determines it is safe to do so.

The Coast Guard proposes to temporarily amend the regulations at 33 CFR 100.501 by changing the date of enforcement for an event in the table to § 100.501. To do this, the Coast Guard proposes to temporarily suspend even number 21 and add a temporary event number 60 with the same event name, sponsor and location, but a different date. The event being changed is the annual “Maryland Swim for Life,” described below.

The Table to § 100.501, event No. 21 establishes the enforcement date for the Maryland Swim for Life. This regulation proposes to temporarily change the enforcement date from “June—3rd Saturday or July—3rd Saturday” to the second Saturday in July, holding this year's marine event on July 10, 2010. The District of Columbia Aquatics Club, which is the sponsor for this event, intends to hold this event annually; however, they have changed the date of the event for 2010 so that it is outside the scope of the existing enforcement period. Due to the need for vessel control while swimmers are in the water along the Chester River, vessel traffic would be temporarily restricted to provide for the safety of participants, spectators and transiting vessels.

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, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

Although this proposed rule prevents traffic from transiting a portion of certain waterways during specified events, the effect of this regulation will not be significant due to the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via marine information broadcasts, so mariners can adjust their plans accordingly. Additionally, this rulemaking does not change the permanent regulated areas that have been published in 33 CFR 100.501, Table to § 100.501. In some cases vessel traffic may be able to transit the regulated area when the Coast Guard Patrol Commander deems it is safe to do so.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this 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 rule would affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in the area where the marine event is being held. This regulation will not have a significant impact on a substantial number of small entities because it will be enforced only during marine events that have been permitted by the Coast Guard Captain of the Port. The Captain of the Port will ensure that small entities are able to operate in the areas where events are occurring when it is safe to do so. In some cases, vessels will be able to safely transit around the regulated area at various times, and, with the permission of the Patrol Commander, vessels may transit through the regulated area. Before the enforcement period, the Coast Guard will issue maritime advisories so mariners can adjust their plans accordingly.

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.

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

This 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 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 effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This 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 which do not individually or cumulatively have a significant effect on the human environment. This rule involves implementation of regulations within 33 CFR part 100 that apply to organized marine events on the navigable waters of the United States that may have potential for negative impact on the safety or other interest of waterway users and shore side activities in the event area. The category of water activities includes but is not limited to sail boat regattas, boat parades, power boat racing, swimming events, crew racing, and sail board racing. Under figure 2-1, paragraph (34)(h), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule. 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 100 as follows:

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-2010-0174), 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. A comment submitted online via http://www.regulations.gov will be considered received by the Coast Guard when the comment is successfully transmitted; a comment submitted via fax, hand delivery, or mail, will be considered as having been received by the Coast Guard when the comment is received at the Docket Management Facility. We recommend that you include your name and a mailing address, an e-mail 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-2010-0174” 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 81/2 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 we 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-2010-0174” 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 for one 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.

This temporary safety zone is necessary to ensure the safety of vessels and the public from hazards associated with an air race. The Captain of the Port Detroit has determined air races in close proximity to watercraft and infrastructure pose a significant risk to public safety and property. The likely combination of large numbers of recreational vessels, airplanes traveling at high speeds and performing aerial acrobatics, and large numbers of spectators in close proximity on the water could easily result in serious injuries or fatalities. Establishing a safety zone around the location of the race's course will help ensure the safety of persons and property at these events and help minimize the associated risks.

This proposed rule is intended to ensure safety of the public and vessels during the setup, course familiarization, time trials and race in conjunction with the Red Bull Air Race. The safety zone will be in effect from 9 a.m. June 3, 2010 through 6:30 p.m. June 6, 2010, to accommodate for the air race and its associated set-up and removal. During that period, the safety zone will be enforced daily from 9 a.m. to 6:30 p.m., June 3rd through 6th, 2010. Specifically, on June 5th and 6th, 2010, the river closure will be enforced during any air race activities. Vessels seeking to transit the zone should contact the Captain of the Port's on-scene representative. The on-scene representative may permit vessels to transit the area when no air race activity is occurring. On June 5, 2010, the river closure will total no more than 5 hours between the hours of 9 a.m. to 6:30 p.m. On June 6, 2010, the river closure will total no more than 6 hours between the hours of 9 a.m. to 6:30 p.m. The Coast Guard expects to have additional information from the event organizer before publication of the final rule and may adjust the hours of enforcement for each day. The Coast Guard also expects the temporary final rule will be effective less than 30 days after publication in the Federal Register because delaying the effective date would be contrary to the public interest due to the need to protect the public from the dangers associated with air racing.

The temporary safety zone will encompass all navigable waters of the United States on the Detroit River, Detroit, MI, bound by a line extending from a point on land southwest of Joe Louis Arena at position 42°19.4′ N; 083°3.3′ W, northeast along the Detroit shoreline to a point on land at position 42°20.0′ N; 083°1.2′ W, southeast to the international border with Canada at position 42°19.8′ N; 083°1.0′ W, southwest along the international border to position 42°19.2′N; 083°3.3′ W, and northwest to the point of origin at position 42°19.4′ N; 083°3.3′ W. (DATUM: NAD 83).

The Captain of the Port will cause notice of enforcement of the safety zone established by this section to be made by all appropriate means to the affected segments of the public. Such means of notification will include, but is not limited to, Broadcast Notice to Mariners and Local Notice to Mariners. Likewise, the Windsor Port Authority intends to restrict vessel movement on the Canadian side of the Detroit River. The exclusionary area on the Canadian side will be aligned with the east and west borders of the U.S. safety zone and will extend to the shoreline along Windsor, ON. The Captain of the Port will issue a broadcast Notice to Mariners notifying the public when enforcement of the safety zone is terminated.

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, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

Although this proposed rule restricts access to the safety zone, the effect of this rule will not be significant because: (i) The safety zone will be in effect for a limited duration; (ii) zone is an area where the Coast Guard expects minimal adverse impact to mariners from the zone's activation; and (iii) the Coast Guard will make notifications via maritime advisories so mariners can adjust their plans accordingly.

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 rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in the portion of the Detroit River discussed above between 9 a.m. and 6 p.m. on June 3, through June 6, 2010.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: this safety zone will be subject to enforcement for a short duration of approximately six hours each day of its effective period. Additionally, small entities such as passenger vessels have been involved in the planning stages of this event and have had opportunities to make alternate arrangements with regards to mooring positions and business operations during the hours this safety zone will be in effect. Furthermore, prior to the event local sailing and yacht clubs will be provided with information by Coast Guard Station Belle Isle on what to expect during the event. Station Bell Isle will do this in order to minimize interruptions in the normal business practices of local sailing and yacht clubs. In the event that this temporary safety zone affects shipping, commercial vessels may request permission from the Captain of the Port Detroit to transit through the safety zone. The Coast Guard will give notice to the public via a Broadcast Notice to Mariners that the regulation is in effect. Additionally, the COTP will suspend enforcement of the safety zone if the event for which the zone is established ends earlier than the expected time.

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.

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 they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact CDR Joseph Snowden, Prevention Department, Sector Detroit, Coast Guard; telephone (313) 568-9580, e-mail Joseph.H.Snowden@uscg.mil. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

This 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 invite your comments on how this proposed rule might impact tribal governments, even if that impact may not constitute a “tribal implication” under the Order.

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. A preliminary environmental analysis checklist supporting this determination is available in the docket where indicated under ADDRESSES. This proposed rule involves the establishment of a temporary safety zone. Based on our preliminary determination, there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 figure 2-1, paragraph (34)(g) of the Instruction and neither an environmental assessment nor a environmental impact statement is required.

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 165 as follows:

This is a summary of the Commission's Notice of Proposed Rulemaking (NPRM) in CC Docket No. 80-286, FCC 10-47, released on March 29, 2010. The full text of this document is available for public inspection during regular business hours in the FCC Reference Center, Room CY-A257, 445 12th Street, SW., Washington, DC 20554.

1. Jurisdictional separations is the process by which incumbent LECs apportion regulated costs between the intrastate and interstate jurisdictions. The NPRM proposes extending the current freeze of part 36 category relationships and jurisdictional cost allocation factors used in jurisdictional separations, which freeze would otherwise expire on June 30, 2010, until June 30, 2011. Extending the freeze will allow the Commission to provide stability for, and avoid imposing undue burdens on, carriers that must comply with the Commission's separations rules while the Commission considers issues relating to comprehensive separations reform.

2. The 2001 Separations Freeze Order, 66 FR 33202, June 21, 2001, froze all part 36 category relationships and allocation factors for price cap carriers and all allocation factors for rate-of-return carriers. Rate-of-return carriers had the option to freeze their category relationships at the outset of the freeze. The freeze was originally established July 1, 2001 for a period of five years, or until the Commission completed separations reform, whichever occurred first. The 2006 Separations Freeze Extension Order, 71 FR 29843, May 24, 2006, extended the freeze for three years or until the Commission completed separations reform, whichever occurred first, and the 2009 Separations Freeze Extension Order, 74 FR 23955, May 22, 2009, extended the freeze until June 30, 2010.

3. In this NPRM the Commission seeks comment on extending the freeze for one year, until June 30, 2011. The proposed extension would allow the Commission to continue to work with the Federal-State Joint Board on Separations to achieve comprehensive separations reform. Pending comprehensive reform, the Commission tentatively concludes that the existing freeze should be extended on an interim basis to avoid the imposition of undue administrative burdens on incumbent LECs. The Commission asks commenters to consider how costly and burdensome an extension of the freeze, or a reversion to the pre-freeze part 36 rules, would be for small incumbent LECs, and whether an extension would disproportionately affect specific types of carriers or ratepayers. Incumbent LECs have not been required to utilize the programs and expertise necessary to prepare separations information since the inception of the freeze almost nine years ago. If the Commission does not extend the separations freeze, and instead allows the earlier separations rules to return to force, incumbent LECs would be required to reinstitute their separations processes. Given the imminent expiration of the current separations freeze, it is unlikely that incumbent LECs would have sufficient time to reinstitute the separations processes necessary to comply with the earlier separations rules.

4. The extended freeze would be implemented as described in the 2001 Separations Freeze Order. Specifically, price-cap carriers would use the same relationships between categories of investment and expenses within part 32 accounts and the same jurisdictional allocation factors that have been in place since the inception of the current freeze on July 1, 2001. Rate-of-return carriers would use the same frozen jurisdictional allocation factors, and would use the same frozen category relationships if they had opted previously to freeze those as well.

Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated in the DATES section of this document. Comments may be filed using: (1) The Commission's Electronic Comment Filing System (ECFS); (2) the Federal Government's eRulemaking Portal; or (3) by filing paper copies. See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).

• Electronic Filers: Comments may be filed electronically using the Internet by accessing the ECFS: http://fjallfoss.fcc.gov/ecfs2/ or the Federal eRulemaking Portal: http://www.regulations.gov. Filers should follow the instructions provided on the Web site for submitting comments.

• For ECFS filers, if multiple docket or rulemaking numbers appear in the caption of this proceeding, filers must transmit one electronic copy of the comments for each docket or rulemaking number referenced in the caption. In completing the transmittal screen, filers should include their full name, U.S. Postal Service mailing address, and the applicable docket or rulemaking number. Parties may also submit an electronic comment by Internet e-mail. To get filing instructions, filers should send an e-mail to ecfs@fcc.gov, and include the following words in the body of the message, “get form.” A sample form and directions will be sent in response.

• Paper Filers: Parties who choose to file by paper must file an original and four copies of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number.

• Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail (although we continue to experience delays in receiving U.S. Postal Service mail). All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

• All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St., SW., Room TW-A325, Washington, DC 20554. The filing hours are 8 a.m. to 7 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes must be disposed of before entering the building.

• Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.

• U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street, SW., Washington, DC 20554.

People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an e-mail to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

This matter shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. See 47 CFR 1.1200, 1.1206. Persons making oral ex parte presentations are reminded that memoranda summarizing the presentations must contain summaries of the substance of the presentations and not merely a listing of the subjects discussed. More than a one or two sentence description of the views and arguments presented generally is required. See 47 CFR 1.1206(b). Other rules pertaining to oral and written ex parte presentations in permit-but-disclose proceedings are set forth in section 1.1206(b) of the Commission's rules. 47 CFR 1.1206(b).

As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in this NPRM. Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments on the NPRM. The Commission will send a copy of the NPRM, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA). See 5 U.S.C. 603(a).

In the 1997 Separations NPRM, the Commission noted that the network infrastructure by that time had become vastly different from the network and services used to define the cost categories appearing in the Commission's part 36 jurisdictional separations rules, and that the separations process codified in part 36 was developed during a time when common carrier regulation presumed that interstate and intrastate telecommunications service must be provided through a regulated monopoly. Thus, the Commission initiated a proceeding with the goal of reviewing comprehensively the Commission's part 36 procedures to ensure that they meet the objectives of the 1996 Act. The Commission sought comment on the extent to which legislative changes, technological changes, and market changes might warrant comprehensive reform of the separations process. Because over twelve years have elapsed since the closing of the comment cycle on the 1997 Separations NPRM, and over eight years have elapsed since the imposition of the freeze, and because the industry has experienced myriad changes during that time, we ask that commenters, in their comments on the present NPRM, comment on the impact of a further extension of the freeze.

The purpose of proposed extension of the freeze is to ensure that the Commission's separations rules meet the objectives of the 1996 Act, and to allow the Commission additional time to consider changes that may need to be made to the separations process in light of changes in the law, technology, and market structure of the telecommunications industry.

The legal basis for the NPRM is contained in sections 1, 2, 4, 201-205, 215, 218, 220, 229, 254, and 410 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154, 201-205, 215, 218, 220, 229, 254 and 410, and 1.1200-1.1216 of the Commission's rules, 47 CFR 1.1, 1.411-1.429, 1.1200-1.1216.

The RFA directs agencies to provide a description of, and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under section 3 of the Small Business Act. Under the Small Business Act, a “small business concern” is one that: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).

We have included small incumbent LECs in this RFA analysis. As noted above, a “small business” under the RFA is one that, inter alia, meets the pertinent small business size standard established by the SBA, and is not dominant in its field of operation. Section 121.201 of the SBA regulations defines a small wireline telecommunications business as one with 1,500 or fewer employees. In addition, the SBA's Office of Advocacy contends that, for RFA purposes, small incumbent LECs are not dominant in their field of operation because any such dominance is not “national” in scope. Because our proposals concerning the part 36 separations process will affect all incumbent LECs providing interstate services, some entities employing 1500 or fewer employees may be affected by the proposals made in this NPRM. We therefore have included small incumbent LECs in this RFA analysis, although we emphasize that this RFA action has no effect on the Commission's analyses and determinations in other, non-RFA contexts. Neither the Commission nor the SBA has developed a small business size standard specifically for providers of incumbent local exchange services. The closest applicable size standard under the SBA rules is for Wired Telecommunications Carriers. Under the SBA definition, a carrier is small if it has 1,500 or fewer employees. According to the FCC's Telephone Trends Report data, 1,311 incumbent LECs reported that they were engaged in the provision of local exchange services. Of these 1,311 carriers, an estimated 1,024 have 1,500 or fewer employees and 287 have more than 1,500 employees. Consequently, the Commission estimates that most incumbent LECs are small entities that may be affected by the rules and policies adopted herein.

None.

The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance and reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or part thereof, for small entities.

As described above, seven years have elapsed since the imposition of the freeze, thus, we ask commenters, in their comments on the present NPRM, address the impact of a further extension of the freeze. We seek comment on the effects our proposals would have on small entities, and whether any rules that we adopt should apply differently to small entities. We direct commenters to consider the costs and burdens of an extension on small incumbent LECs and whether the extension would disproportionately affect specific types of carriers or ratepayers.

Implementation of the proposed freeze extension would ease the administrative burden of regulatory compliance for LECs, including small incumbent LECs. The freeze has eliminated the need for all incumbent LECs, including incumbent LECs with 1500 employees or fewer, to complete certain annual studies formerly required by the Commission's rules. If an extension of the freeze can be said to have any affect under the RFA, it is to reduce a regulatory compliance burden for small incumbent LECs, by abating the aforementioned separations studies and providing these carriers with greater regulatory certainty.

None.

The NPRM does not propose any new or modified information collections subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new, modified, or proposed “information collection burden for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, 44 U.S.C. 3506(c)(4).

For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 36 as follows:

I. Overview of the Hazardous Materials Regulations

The Hazardous Materials Regulations (HMR; 49 CFR parts 171-180) govern the safe transportation of hazardous materials. The HMR are designed to achieve three goals:

1. To ensure that hazardous materials are packaged and handled safely and securely during transportation;

2. To provide effective communication to transportation workers and emergency responders of the hazards of the materials being transported; and

3. To minimize the consequences of an incident should one occur.

The hazardous material regulatory system is a risk management system that is prevention-oriented and focused on identifying a safety or security hazard and reducing the probability and quantity of a hazardous material release. Under the HMR, hazardous materials are categorized by analysis and experience into hazard classes and packing groups based upon the risks they present during transportation. The HMR specify appropriate packaging and handling requirements for hazardous materials, and require a shipper to communicate the material's hazards through use of shipping papers, package marking and labeling, and vehicle placarding. The HMR require shippers to provide emergency response information applicable to the specific hazard or hazards of the material being transported. The HMR mandate training requirements for persons who prepare hazardous materials for shipment or who transport hazardous materials in commerce. Finally, the HMR include operational requirements applicable to each mode of transportation.

PHMSA reviews the HMR on a continuing basis to determine whether revisions or amendments are necessary to ensure a high level of safety for the safe transportation of hazardous materials in commerce. During our regulatory review process, we look for opportunities that may exist to enhance safety, such as by minimizing misunderstanding of regulatory requirements for the transportation of hazardous materials and, where opportunities exist, to reduce the regulatory burden on industry while maintaining a high level of safety. We believe opportunities exist to clarify and simplify current requirements in the HMR applicable to the transportation of combustible liquids, thereby reducing compliance burdens on shippers and carriers while facilitating movement of these materials in domestic and international commerce. This initiative is based on our ongoing review process, input from the regulated community, review of requests for letters of interpretation and clarification concerning combustible liquids, and written and oral questions pertaining to combustible liquids that have been presented to PHMSA's Hazardous Materials Information Center.

On February 27, 1968, the Hazardous Materials Regulation Board—the predecessor agency to the Research and Special Programs Administration (RSPA) and, subsequently, the Pipeline and Hazardous Materials Safety Administration (PHMSA)—published a notice of proposed rulemaking (NPRM) under Docket No. HM-3 (33 FR 3382) proposing to re-define the term “flammable liquid,” in order to harmonize the definition with international standards and better address the risks such materials present in transportation. On February 21, 1970, the Board published an NPRM under Docket No. HM-42 (35 FR 3298) proposing to create and define a new class of materials identified as “combustible liquids” to address a lack of hazard warning communication concerning these materials, and the hazards posed by transportation of these materials at temperatures equal to or exceeding their flash points. Liquids in this higher flash point range (80 °F to 200 °F) include kerosene, fuel oil, turpentine and certain alcohols, all of which present fire hazards during transportation, and are referred to generically as “combustible liquids.” The 200 °F upper limit is commonly used by industry, government, and the National Fire Protection Association (NFPA) as the regulatory limit for defining flammable/combustible liquids.

On December 5, 1970, the Board published an NPRM under Docket No. HM-67 (35 FR 18534) proposing to change the method of determining the flash point of materials from the Tagliabue open-cup test method to the Tagliabue closed-cup test method in an effort to establish a more accurate flash point of materials.

The issues addressed in these three notices were consolidated under Docket HM-102 and published as an NPRM on June 15, 1972 (37 FR 11898). The NPRM included proposals for a new definition for the class of materials identified as “flammable liquid” and created and defined a new class of materials identified as “combustible liquid,” in addition to modifying the definition for pyrophoric liquids within the flammable liquid hazard class.

On January 24, 1974, the Hazardous Materials Regulation Board published a final rule under Docket HM-102 (39 FR 2768) that, among other issues, (1) Specified a new definition for the class of materials identified as “flammable liquid;” (2) created and defined a new class of materials identified as “combustible liquids;” (3) modified the definition for “pyrophoric liquid” within the flammable liquid class; and (4) set forth the requirements for the materials that were covered by these new definitions.

The final rule defined these hazard classes as follows:

1. A “flammable liquid” is any liquid having a flash point below 100 °F (37.8 °C) that does not meet one of the definitions specified under then § 173.300 (i.e., materials defined as compressed gases).

2. A “combustible liquid” is any liquid having a flash point at or above 100 °F (37.8 °C), and below 200 °F (93.3 °C).

3. A “pyrophoric liquid” is “any liquid that ignites spontaneously in dry or moist air at or below 130 °F (54.5 °C).

In following years, the agency published additional notices proposing revisions to the provisions for flammable and combustible materials, culminating in the publication of a final rule on December 21, 1990 under Docket HM-181 (55 FR 52402). Generally, this rule comprehensively revised the HMR with respect to hazard communication, classification, and packaging requirements to enhance safety through better classification and performance-oriented, risk based packaging, and to promote flexibility and technological innovation in packaging, reduce the need for special permits (formerly “exemptions”), and facilitate international commerce. The final rule adopted international standards (United Nations Recommendations on the Transport of Dangerous Goods or “UN Recommendations”) for defining flammable liquids and retained a domestic exception for flammable liquids reclassed as combustible liquids. The upper flash point range for flammable liquids was subsequently extended to meet the UN standard of 60 °C (140 °F) for flammable liquids. The definition for combustible liquids under the HMR was retained both as a domestic classification option for liquids with flash points between 38 °C (100 °F) and 60 °C (140 °F) and as a requirement for liquids with flash points between 60 °C (140 °F) and below 93 °C (200 °F). The classification system in the UN Recommendations has no combustible liquid category or hazard class.

Commenters to the HM-181 rulemaking asserted that the exceptions provided in the HMR for the transportation of combustible liquids create an unnecessary variance between domestic and international transportation and increase the potential for non-compliance. For instance, commenters stated the domestic exception would lead to identical materials being classified differently, and would result in confusion among transportation, enforcement, and emergency response personnel. At the time, we disagreed with these commenters and stated that although different classifications for the same materials could occur under this exception, we anticipated little or no confusion on the part of shippers already dealing with a dual packaging and marking system, i.e., differing requirements for domestic and international transportation. We also stated that the exception for combustible liquids would not hamper enforcement or emergency response personnel who are trained in the use of the HMR, UN identification numbers, the identification of materials using DOT's placarding system, and DOT's Emergency Response Guidebook.

This issue was raised again in a subsequent HM-181 final rule published on December 20, 1991 (56 FR 66124) that responded to petitions for reconsideration of certain aspects of the rule. Several petitioners urged the agency to remove the combustible liquid class definition and the reclassification option. The petitioners stated that the domestic combustible liquid classification introduced unneeded regulatory complexity and violated the stated aims of HM-181 to simplify the HMR. This being both a safety and economic issue, we disagreed with the petitioners who would eliminate the combustible liquid class altogether, believing that the significant number of domestically regulated materials with flash points between 38 °C (100 °F) and 93 °C (200 °F) pose risks in transportation that cannot be ignored.

Under HM-181, we revised the HMR to clarify that only flammable liquids that do not meet the definition of any other hazard class may be reclassed as combustible liquids. This revision was intended to prevent reclassification of materials that meet the definition of a hazardous substance or hazardous waste and, thus, meet the definition for a Class 9 (Miscellaneous) material. We also narrowed the provisions to generally prohibit reclassification for materials offered for air or vessel transportation, with certain exceptions. The phrase “except Class 9” was subsequently removed from §§ 173.120(b)(1) and (b)(2), and 173.150 under the Docket HM-181 Correction/Response final rule published on October 1, 1992 (57 FR 45446), in which the Class 9 definition was clarified to state that a material which meets the definition of another hazard class, but also falls within one of the Class 9 criteria (e.g., hazardous substance) does not meet the definition of Class 9.

Section 173.120 of the HMR currently defines a “flammable liquid” as a liquid having a flash point of not more than 60 °C (140 °F), or any material in a liquid phase with a flash point at or above 38 °C (100 °F) that is intentionally heated and offered for transportation or transported at or above its flash point in a bulk packaging, with some exceptions for liquids that also meet the definition for Division 2.1 (Flammable gas), 2.2 (Non-flammable gas), or 2.3 (Poisonous gas) materials, as defined in § 173.115; mixtures that are not offered for transportation at or above their flash points; liquids with a flash point greater than 35 °C (95 °F) that do not sustain combustion; liquids with a flash point greater than 35 °C (95 °F) and with a fire point (the temperature at which the liquid will continue to burn after ignition) greater than 100 °C (212 °F); and liquids with a flash point greater than 35 °C (95 °F) which is in a water-miscible solution with a water content of more than 90 percent by mass.

In addition, § 173.120 of the HMR defines a “combustible liquid” as any liquid that does not meet the definition of any other hazard class specified in this subchapter and has a flash point above 60 °C (140 °F) and below 93 °C (200 °F). Further, in domestic transportation, a flammable liquid with a flash point at or above 38 °C (100 °F) that does not meet the definition of any other hazard class may be reclassed as a combustible liquid. This provision does not apply to transportation by vessel or aircraft, except where other means of transportation is impracticable. An elevated temperature material that meets the definition of a Class 3 (Flammable liquid) material because it is intentionally heated and offered for transportation or transported at or above its flash point may not be reclassed as a combustible liquid.

A flash point is the minimum temperature at which a liquid gives off vapor within a test vessel in sufficient concentration to form an ignitable mixture with air near the surface of the liquid. Materials with higher flashpoints are thus less likely to ignite than materials with lower flash points. Because of their higher flash points, combustible liquids do not pose as great a risk in transportation as flammable liquids. Therefore, the regulatory requirements applicable to their transportation are less stringent than those for flammable liquids. For example, combustible liquids transported in non-bulk packagings are excepted from all HMR requirements, unless the combustible liquid also meets the definition for a hazardous substance, hazardous waste, or marine pollutant. In addition, combustible liquids may be transported in non-specification bulk packagings. A combustible liquid that is not a hazardous substance, a hazardous waste, or a marine pollutant is not subject to HMR requirements if it is a mixture of one or more components that has a flash point at or above 93 °C (200 °F), comprises at least 99 percent of the volume of the mixture, and is not transported as a liquid at a temperature at or above its flash point. Also, a combustible liquid that does not sustain combustion is not subject to the requirements of the HMR as a combustible liquid. Either the test method specified in ASTM D 4206 or the procedure in appendix H of part 173 may be used to determine if a material sustains combustion when heated under test conditions and exposed to an external source of flame.

The HMR provide additional exceptions for flammable (Class 3) and combustible liquids under § 173.150. Limited quantities of flammable and combustible liquids are excepted from labeling requirements, unless the material also meets the definition of Division 6.1 (Poison) or is offered for transportation or transported by aircraft, and the specification packaging requirements of the HMR when packaged in combination packagings, each not exceeding 30 kg (66 pounds) gross weight, in accordance with this section. In addition, shipments of limited quantities are not subject to placarding. A limited quantity of a flammable or combustible liquid may be reclassed and renamed as a “consumer commodity” as defined in § 171.8 of the HMR. An aqueous solution containing 24 percent or less alcohol by volume and no other hazardous material may be reclassed as a combustible liquid, and is not subject to the HMR requirements if it contains no less than 50 percent water.

In this ANPRM, PHMSA is soliciting comments on issues related to the transportation of combustible liquids in both domestic and international commerce. We have received two petitions for rulemaking suggesting that domestic requirements for the transportation of combustible liquids should be harmonized with international standards. In addition, we have received a petition for rulemaking suggesting that the HMR should include more expansive domestic exceptions for shipments of combustible liquids. The petitions are described below.

The International Vessel Operators Hazardous Materials Association (VOHMA) submitted a petition for rulemaking [P-1498; PHMSA-2007-28238] concerning differing domestic and international requirements for the transportation of combustible liquids. As indicated above, the UN Recommendations do not include a definition or classification for combustible liquids. The UN Recommendations are not regulations, but rather are recommended standards issued by the UN Sub-Committee of Experts on the Transport of Dangerous Goods. These recommendations are amended and updated biennially and serve as the basis for many national, regional and international modal regulations, including the International Civil Aviation Organization's Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Technical Instructions) and the International Maritime Dangerous Goods (IMDG) Code.

In the UN Recommendations on the Transport of Dangerous Goods (Model Regulations), 15th Revised Edition, Chapter 2.3; Section 2.3.1.2, “Flammable liquids” are defined as liquids, or mixtures of liquids, or liquids containing solids in solution or suspension (for example, paints, varnishes, lacquers, etc., but not including substances otherwise classified on account of their dangerous characteristics) which give off a flammable vapor at temperatures of not more than 60 °C (140 °F), closed-cup test, or not more than 65.6 °C (150.08 °F), open-cup test, normally referred to as the flash point. This class also includes:

a. Liquids offered for transport at temperatures at or above their flash point; and

b. Substances that are transported or offered for transport at elevated temperatures in a liquid state and which give off a flammable vapor at a temperature at or below the maximum transport temperature.

Liquid desensitized explosives (see 2.3.1.4) are also included in the Class 3 hazard class. Liquid desensitized explosives are explosive substances which are dissolved or suspended in water or other liquid substances, to form a homogeneous liquid mixture to suppress their explosive properties (2.1.3.6.3). Entries in the Dangerous Goods List for liquid desensitized explosives are: UN1204, UN 2059 UN 3064, UN 3343, UN 3357 and UN 3379.

Liquids meeting the definition in Chapter 2.3; Section 2.3.1.3 with a flash point of more than 35 °C (95 °F) which do not sustain combustion are not considered hazardous materials for purposes of the UN Recommendations, the ICAO Technical Instructions, or the IMDG Code. Liquids are considered to be unable to sustain combustion for the purposes of these Regulations (i.e., they do not sustain combustion under defined test conditions) if:

a. They have passed a suitable combustibility test (see SUSTAINED COMBUSTIBILITY TEST prescribed in the Manual of Tests and Criteria, Part III, sub-section 32.5.2;

b. Their fire point according to ISO 2592:2000 is greater than 100 °C

(212 °F); or

c. They are water miscible solutions with a water content of more than 90% by mass.

In its petition, VOHMA notes that the differing domestic and international requirements for combustible liquids has resulted in conflicting and confusing hazard communication requirements with the result that international shipments may be frustrated as foreign authorities attempt to reconcile HMR hazard communication schemes with international regulations. For example, VOHMA notes that many paints, inks, adhesives, solvents, and petroleum products have flash points between 60 °C (140 °F) and 93 °C (200 °F) and are offered for transportation as combustible liquids within the United States. However, the HMR permit such shipments to be described on a shipping paper and to display markings, labels, and placards in the same manner as shipments of flammable liquids with flash points of less than 60 °C (140 °F). When these shipments are destined for export to a jurisdiction outside the United States, foreign inspectors, stowage planners, interlining carriers, and intermodal feeder companies may become confused by the display of a UN identification number of a material that is not regulated in international commerce and thus may delay forwarding the shipments until the confusion is resolved. We agree with VOHMA that these frustrated shipments impede commerce and may also result in additional risks in the ports and terminals where they are held.

In its petition, VOHMA also expresses concern that HMR provisions that permit reclassification of flammable liquids with a flash point at or above 38 °C (100 °F) as combustible liquids could result in the movement of undeclared shipments in international commerce. Reclassed combustible liquids are excepted from the HMR when transported in non-bulk packagings such as one-gallon cans, five-gallon jerricans, or 55-gallon drums. However, materials with flash points between 38 °C (100 °F) and 60 °C (140 °F) are fully regulated as Class 3 materials in international commerce. We agree with VOHMA that unmarked and unlabeled packages of reclassed combustible liquids may find their way into international distribution with the result that the shipments are not declared as dangerous goods and will not be appropriately handled and stowed in international transportation.

To address these problems, VOHMA asks PHMSA to use the “Combustible liquid, n.o.s.” proper shipping name entry in the Hazardous Materials Table (HMT), with an associated technical name in parentheses, when the material is reclassified in accordance with § 173.150(f) and is intended for rail or highway transportation only, or has a flash point above 60 °C (140 °F) but below 93 °C (200 °F). This would serve to distinguish shipments regulated only in the United States from shipments regulated in international commerce.

The Dangerous Goods Advisory Council (DGAC) also submitted a petition for rulemaking [P-1531; PHMSA-2008-0303] for amendment of the requirements for combustible liquids in bulk packagings in order to reduce port congestion and improve transportation efficiency in port areas. A bulk packaging is defined in § 171.8 as a packaging, other than a vessel or barge, including a transport vehicle or freight container, in which hazardous materials are loaded with no intermediate form of containment and that has: (1) A maximum capacity greater than 450 L (119 gallons) as a receptacle for a liquid; (2) a maximum net mass greater than 400 kg (882 pounds) and a maximum capacity greater than 450 L (119 gallons) as a receptacle for a solid; or (3) a water capacity greater than 454 kg (1000 pounds) as a receptacle for a gas as defined in § 173.115 of the HMR. The DGAC petition highlights many of the issues identified by VOHMA in its petition, with a particular focus on problems encountered in international transportation for shipments of materials DGAC terms “high flash point combustible liquids”—that is, combustible liquids with flashpoints between 60 °C (140 °F) and 93 °C (200 °F). DGAC suggests that the regulatory differences between the HMR and international regulatory requirements for these combustible liquids are disruptive to the flow of goods in port areas and contribute to port congestion. According to DGAC, imported bulk shipments of high flash point combustible liquids arriving in U.S. ports must be marked and placarded in accordance with HMR requirements. Similarly, the marks and placards that are applied to bulk shipments of such combustible liquids for U.S. transportation must be removed in the port prior to export. DGAC estimates that export shipments are delayed for an average of three days awaiting removal of HMR-required marks and placards and import shipments are delayed an average of five days awaiting application of HMR-required marks and placards. To alleviate this problem, DGAC requests that PHMSA except high flash point combustible liquids from all HMR requirements when transported in specification packages of less than 3000 liters capacity, (the upper capacity limit for intermediate bulk containers (IBCs), or when in an ISO (UN) portable tank in international commerce.

U. S. Custom Harvesters, Inc. (Custom Harvesters) also submitted a petition for rulemaking [P-1536; PHMSA-2009-0099] requesting modification of current requirements applicable to combustible liquids. According to the petition, a custom harvester has invested in the equipment (which includes grain harvesting combines, silage harvesters, grain trucks, tractors and grain carts) necessary to harvest wheat, corn, corn silage and cotton. The custom harvester industry replaces the farmer in the field during harvest.

Custom Harvesters is concerned that current requirements applicable to bulk shipments of combustible liquids inhibit the industry's ability to hire seasonal workers to transport the diesel fuel necessary to re-fuel harvesting equipment in the fields. Because the diesel fuel is typically transported from a local service station or farm cooperative in tanks with capacities greater than 450 L (119 gallons) (i.e., in bulk quantities), the commercial motor vehicles transporting the diesel fuel must be operated by a driver with a commercial driver license with a hazmat endorsement. (In accordance with 49 CFR part 383, a hazmat endorsement is required for drivers of commercial motor vehicles that transport placarded amounts of hazardous materials. Bulk shipments of combustible liquids must be placarded.) Custom Harvesters asks us to consider an exception from placarding for combustible liquids transported in quantities that do not exceed 3785 L (1,000 gallons) in a single packaging.

Approximately 100 persons submitted comments in support of the U.S. Custom Harvesters' petition. The commenters stress the difficulty of hiring seasonal, foreign workers who may not be able to obtain a CDL with a hazmat endorsement in a timely fashion.

Based on the petitions for rulemaking described in the previous section of this preamble and our own review of domestic and international regulations applicable to the transportation of combustible liquids, we have identified a number of issues that we may wish to address through rulemaking, including: (1) Harmonizing the HMR definitions and requirements for combustible liquids with international standards; (2) modifying HMR requirements for marking and placarding shipments of combustible liquids to eliminate confusion that occurs when shipments marked and placarded for domestic transportation are transported in international commerce; and (3) expanding current HMR exceptions for combustible liquids to accommodate unique operational requirements. These issues are discussed in more detail below.

Because there is no provision in the UN Recommendations, the International Civil Aviation Organization's (ICAO) Technical Instructions for the Safe Transport of Dangerous Goods by Aircraft, or the International Maritime Dangerous Goods (IMDG) Code for flammable liquids to be reclassed as combustible liquids and, indeed, no international regulation of liquids with a flash point over 60 °C (140 °F), we recognize that the HMR provisions for the transportation of combustible liquids may potentially be confusing to both domestic and international shippers and carriers of flammable and combustible liquid shipments. We also recognize this lack of clarity may present a tangible safety concern, such as the mishandling or misidentification of these shipments in transportation, or the transportation of undeclared shipments. Further, in addition to our primary focus on the safe transportation of hazardous materials, one of our associated goals is to facilitate international commerce through harmonization with international standards, to the extent that harmonization does not compromise our safety objectives. Therefore, we are considering a proposal to eliminate the current domestic exception that allows the reclassification of high flash point flammable liquids (i.e., those with a flash point at or above 38 °C (100 °F)) as combustible liquids. This potential revision would establish a uniform definition for a flammable liquid as a liquid having a flash point of not more than 60 °C (140 °F), for both domestic and international transportation. Non-bulk shipments of these materials could then be consistently transported as flammable liquids in the United States and abroad, thereby reducing the possibility for the frustration or unsafe handling of shipments whether transported within or outside the United States and the problem of differing marking, labeling and placarding requirements for domestic and international shipments.

However, to the extent there is justification for providing relief from some, if not all, provisions of the HMR applicable to high flash point flammable liquids, we may want to consider a revision to the HMR that would include the current domestic exceptions for high-flash point flammable liquids in non-bulk packagings in a revised set of requirements for Class 3 materials, thereby eliminating the necessity to reclass these materials as combustible liquids to utilize the exceptions. We believe this alternative could be less cumbersome and could facilitate a clearer understanding of the regulations.

In addition to considering harmonizing the HMR definitions and requirements for flammable liquids with international standards, we are considering whether utilization of unique identifiers for combustible liquid shipments could help to eliminate the confusion that currently results when shipments of reclassed combustible liquids or combustible liquid shipments regulated under the HMR but not regulated under international standards are transported to or from the United States.

As VOHMA notes in its petition, the HMR currently permit reclassed combustible liquids in bulk packagings to be described on a shipping paper (except the hazard class must be modified to read “Combustible liquid”) and marked and placarded in the same manner as materials with flash points under 60 °C (140 °F). Thus, a shipment of paint reclassed as a combustible liquid would be described on a shipping paper as “UN1263, Paint, Combustible Liquid, III” and placarded with a Class 3 placard (without text) displaying the UN identification number “1263”. Even though these shipments are not regulated for international transportation, the shipping paper entries and placards suggest that this is a fully regulated shipment. As VOHMA suggests, we could require shippers who reclass flammable liquids as combustible liquids to utilize the domestic identification number NA1993, the proper shipping name “Combustible liquid, n.o.s.,” followed by the technical name for the material, as listed in the § 172.101 HMT, in parentheses (for example, “NA1993, Combustible liquid, n.o.s. (paint), III). Bulk packagings containing reclassed combustible liquids would be marked COMBUSTIBLE LIQUID and placarded with the COMBUSTIBLE placard and the domestic identification number NA1993.

For international shipments of materials regulated as combustible liquids under the HMR but not regulated as hazardous materials under international regulations, we could develop a hazard communication scheme that would clearly identify these shipments when transported in the United States, but that would not be confusing to foreign officials and transport personnel when transported in international commerce. For example, we could except such shipments from placarding requirements and instead require bulk packages containing combustible liquids to be marked COMBUSTIBLE LIQUID and NA1993 (the domestic identification number). These identifiers are not recognized internationally and so may be less likely to cause confusion or shipment delays overseas. Alternatively, we could adopt DGAC's suggestion and provide an exception from marking and placarding requirements for high flash point combustible liquids.

As the petition from the U. S. Custom Harvesters suggests, there are situations where current HMR requirements for the transportation of combustible liquids create an operational burden for those who use combustible liquids in agricultural and similar operations. Moreover, the HMR exception from regulation for combustible liquids in non-bulk packagings may lead shippers and users of combustible liquids to use less efficient transportation methods—such as utilizing several non-bulk packagings rather than a single bulk packaging or making multiple trips using non-bulk packagings—to avoid the regulatory costs associated with fully regulated bulk shipments. Less efficient transport methods may also be less safe transport methods if they increase the number of trips necessary to deliver the materials and the number of times the material must be handled before it is delivered to its destination.

We are considering expanding current exceptions applicable to the transportation of combustible liquids to accommodate unique operational requirements or needs. For example, as the U. S. Custom Harvesters petition suggests, we are considering whether to expand current exceptions applicable to non-bulk shipments of combustible liquids to shipments of less than a threshold amount, such as 3,785 L (1,000 gallons). Alternatively, we may wish to consider expanding current exceptions for hazardous materials that are transported in support of agricultural operations as specified in § 173.5, to include activities such as the harvesting operations described in the U. S. Custom Harvesters petition. For liquids, the maximum quantity authorized in § 173.5(b) is currently 1,900 L (502 gallons). Or we may wish to consider expanding the current materials of trade (MOTs) exceptions in § 173.6 to incorporate an exception for combustible liquids transported in bulk up to a maximum quantity, such as 1,500 L (400 gallons) as currently authorized for certain Class 9 mixtures or 3,785 L (1000 gallons) as requested by the U.S. Custom Harvesters, in support of refueling operations or as a general exception for all combustible liquids.

Currently, § 173.150(f)(2) specifies that the requirements of the HMR do not apply to a material classed as a combustible liquid in a non-bulk packaging unless the combustible liquid is a hazardous substance, a hazardous waste, or a marine pollutant. Simply put, under these specific conditions, a combustible liquid in a non-bulk packaging is not subject to the HMR. Section 173.140 of the HMR defines a Class 9 miscellaneous hazardous material as a material which presents a hazard during transportation but which does not meet the definition of any other hazard class. Class 9 materials include any material which has an anesthetic, noxious or other similar property which could cause extreme annoyance or discomfort to a flight crew member so as to prevent the correct performance of assigned duties. It also includes any material that meets the definition in § 171.8 of the HMR for an elevated temperature material, a hazardous substance, a hazardous waste, or a marine pollutant.

Applied together, these two sections of the HMR indicate that a flammable liquid in a non-bulk packaging and reclassed as a combustible liquid, is not subject to the HMR, but could, nonetheless, be regulated under the HMR when it meets the criteria for Class 9 material, i.e., a marine pollutant. To illustrate, a material that is a marine pollutant, does not meet any other hazard class definition, and has a flashpoint between 140 °F and 200 °F, is classed as a Class 9 material under the IMDG Code and may be transported under the provision of §§ 171.22 and 171.23 (formerly § 171.12) as a Class 9 material. However, this same material could be classed as a combustible liquid under the HMR. Likewise, a material that is an excepted package for limited quantities for Class 7 (radioactive materials) could be transported as a combustible liquid because of similar language under the exception criteria for Class 7 (radioactive materials) found in §§ 173.421 and 173.422.

We believe there are instances when a shipment transported both domestically and internationally under these scenarios could cause confusion or undue hardship, may frustrate shipments, or could create an unnecessary risk along the transportation cycle. As previously noted, one of our objectives in reviewing the HMR is to increase international harmonization without sacrificing our safety goals. We believe an alternative may exist to maintain an acceptable level of safety in the transportation of hazardous substances and hazardous wastes as Class 9 materials, without their inclusion under the current combustible liquids definition or Class 7 (radioactive materials) exceptions. Therefore, we are considering a proposal to remove the phrase “which does not meet the definition of any other hazard class” from the definitions of combustible liquids and Class 9 materials. In addition, we are considering listing “stand-alone” restrictions for each of these materials, and would rely on the Precedence of Hazard Table under § 173.2a for the proper classification of materials having more than one hazard. Because the section in the HMR regarding excepted packages for limited quantities of Class 7 (radioactive materials) also contains similar wording to the two classes noted above, we are also considering a revision to remove the phrase “meet the definition of a hazardous substance or hazardous waste” from § 173.422 and § 173.424.

These revisions may more clearly indicate that if a shipment of a material is a Class 9 or Class 7 material in a non-bulk packaging, it would be transported as a Class 9 or Class 7 material, respectively, and not a combustible liquid. We believe such revisions could reduce undue burden on the regulated community, mitigate the potential for the inaccurate or contradictory classification of Class 7 (radioactive materials), Class 9, and combustible liquid materials, and increase the level of safety during the transportation of these materials.

PHMSA invites commenters to submit comments based on the above discussion and the following questions:

1. Should the HMR continue to apply to materials with a flashpoint above 60° C (140° F) and below 93° C (200° F)? What benefits would result from de-regulation of combustible liquids? What are the safety implications of such de-regulation? How would such de-regulation affect emergency response?

2. Should the HMR continue to permit Class 3 materials with flashpoints between 38° C (100° F) and 60° C (140° F) to be reclassed and transported as combustible liquids? What are the benefits of eliminating this reclassification exception? Would there be costs associated with eliminating this reclassification exception? What are the safety implications of eliminating the reclassification exception? How would elimination of the reclassification exception affect emergency response?

3. Should the HMR provide expanded exceptions for the transportation of combustible liquids? For example, should the HMR except combustible liquids below a certain threshold (e.g., not more than 1,893 L (500 gallons), 3000 L (793 gallons), 3,785 L (1,000 gallons), or 13,249 L (3,500 gallons) from packaging, hazard communication, or other requirements? What are the potential impacts on hazard communication and emergency response notification of such changes?

4. Should the HMR include expanded exceptions for farm operations or agribusinesses? Should the HMR include expanded materials of trade exceptions for persons who transport combustible liquids? What are the potential impacts on hazard communication and emergency response notification of such changes? Are there additional exceptions that should be considered?

5. Should the HMR continue to permit combustible liquids to be described using shipping names and identification numbers applicable to Class 3 materials? Should PHMSA adopt a requirement for all combustible liquids to be described as “Combustible liquid, n.o.s.”? For example, for hazardous material shipping names currently in the § 172.101 HMT, such as Paint, Diesel fuel, Fuel oil, Kerosene, Turpentine, Methallyl alcohol, etc. What safety benefits would result from the use of shipping descriptions unique to combustible liquid materials? How would such a change affect emergency response?

6. Should the HMR provide for use of a unique combustible liquid marking (e.g., the words “COMBUSTIBLE” or “COMBUSTIBLE LIQUID” in red letters on a white background) in place of COMBUSTIBLE placards and other hazard communication for bulk shipments of combustible liquids? Should the HMR provide for use of the domestic identification number, NA1993, on bulk packages utilizing a combustible liquid marking? What are the potential impacts on hazard communication and emergency response notification of such a change? Are there other practical alternatives to use of COMBUSTIBLE placards for bulk shipments?

PHMSA will base any future proposal for changes on the suggestions and comments provided by interested parties and our own initiatives. Additionally, any proposals would include the analyses required under the following statutes and executive orders in the event we determine that rulemaking is appropriate:

Executive Order (E.O.) 12866 requires agencies to regulate in the “most cost-effective manner,” to make a “reasoned determination that the benefits of the intended regulation justify its costs,” and to develop regulations that “impose the least burden on society.” We therefore request comments, including specific data if possible, concerning the costs and benefits that may be associated with revisions to the HMR based on the issues presented in this notice. A rule that is considered significant under E.O. 12866 must be reviewed and cleared by the Office of Management and Budget before it can be issued.

E.O. 13132 requires agencies to assure meaningful and timely input by state and local officials in the development of regulatory policies that may have a substantial, direct effect on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. We invite state and local governments with an interest in this rulemaking to comment on any effect that revisions to the HMR relative to the transportation of combustible liquids may cause.

E.O. 13175 requires agencies to assure meaningful and timely input from Indian tribal government representatives in the development of rules that “significantly or uniquely affect” Indian communities and that impose “substantial and direct compliance costs” on such communities. We invite Indian tribal governments to provide comments if they believe there will be an impact.

Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.), we must consider whether a proposed rule would have a significant economic impact on a substantial number of small entities. “Small entities” include small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations under 50,000. If you believe that revisions to the HMR relative to the transportation of combustible liquids would have a significant economic impact on small entities, please provide information on such impacts.

Any future proposed rule would be developed in accordance with Executive Order 13272 (“Proper Consideration of Small Entities in Agency Rulemaking”) and DOT's procedures and policies to promote compliance with the Regulatory Flexibility Act to ensure that potential impacts on small entities of a regulatory action are properly considered.

Section 1320.8(d), Title 5, Code of Federal Regulations requires that PHMSA provide interested members of the public and affected agencies an opportunity to comment on information collection and recordkeeping requests. It is possible that new or revised information collection requirements could occur as a result of any future rulemaking action.

The National Environmental Policy Act, 42 U.S.C. 4321-4375, requires Federal agencies to analyze proposed actions to determine whether the action will have a significant impact on the human environment. The Counsel on Environmental Quality (CEQ) regulations order federal agencies to conduct an environmental review considering (1) The need for the proposed action, (2) alternatives to the proposed action, (3) probable environmental impacts of the proposed action and alternatives, and (4) the agencies and persons consulted during the consideration process. 40 CFR 1508.9(b). PHMSA welcomes any data or information related to environmental impacts that may result from a future rulemaking addressing the transportation of combustible liquids.

Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the document (or signing the document, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477) or you may visit http://www.dot.gov/privacy.html.

The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing any standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. For purposes of these requirements, Federal agencies may participate in the establishment of international standards, so long as the standards have a legitimate domestic objective, such as providing for safety, and do not operate to exclude imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. PHMSA participates in the establishment of international standards in order to protect the safety of the American public, and we would assess the effects of any rule to ensure that it does not exclude imports that meet this objective. Accordingly, any proposals would be consistent with PHMSA's obligations under the Trade Agreement Act, as amended.

1. 49 U.S.C. 5103(b) authorizes the Secretary of Transportation to prescribe regulations for the safe transportation, including security, of hazardous materials in intrastate, interstate, and foreign commerce.

2. 49 U.S.C. 5120(b) authorizes the Secretary of Transportation to ensure that, to the extent practicable, regulations governing the transportation of hazardous materials in commerce are consistent with standards adopted by international authorities. This notice considers potential amendments to the HMR that would maintain alignment with international standards by incorporating various amendments. The continually increasing amount of hazardous materials transported in international commerce warrants the harmonization of domestic and international requirements to the greatest extent * * * The majority of amendments in any harmonization rule should result in cost savings and ease the regulatory compliance burden for shippers engaged in domestic and international commerce, including trans-border shipments within North America.

A regulation identifier number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN contained in the heading of this document can be used to cross-reference this action with the Unified Agenda.