EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Mr. Gene Benbow,<PHONE_NUMBER>

Syngenta Crop Protection, LLC

Syngenta Crop Protection, LLC PP#

	EPA has received a pesticide petition PP # XX from Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419 requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180

 by establishing a tolerance for residues of            the insecticide avermectin B1(a mixture of avermectins containing greater than or equal to 80% avermectin B1a (5-O- demethyl avermectin A1) and less than or equal to 20% avermectin B1b (5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl) avermectin A1)) in or on the raw agricultural commodity

      Edible-podded legume vegetables subgroup 6A at 0.03 parts per million       Succulent shelled pea and bean subgroup 6B at 0.005 parts per million       Dried shelled pea and bean (except soybean) subgroup 6C at 0.005 parts per million (ppm).

EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. The metabolism of abamectin in plants is adequately understood and the residues of concern include the parent insecticide abamectin (also referred to as avermectin B1 which is a mixture of a minimum of 80% avermectin B1a and a maximum of 20% avermectin B1b) and the delta 8,9-isomer of the B1a and of the B1b components of the parent insecticide.

 Analytical method. The analytical methods involve homogenization, filtration, partition, and cleanup with analysis by high performance liquid chromatography (HPLC)-fluorescence detection. The methods are sufficiently sensitive to detect residues at or above the tolerances proposed. All methods have undergone independent laboratory validation.

 Magnitude of residues. Complete residue data to support the requested tolerances have been submitted.  The requested tolerances are adequately supported.   	 B. Toxicological Profile A full description of the studies regarding the toxicity, animal metabolism, and metabolite toxicology, of emamectin benzoate can be found in EPA's memorandum, "Abamectin.  Human Health Risk Assessment for Uses on Caneberry Subgroup 13-07A; Soybean; Sweet Corn; Ear Tags for Lactating Dairy Cattle; Golf Course Turf; Bean; Onion, Green, Subgroup 3-07B; Fruit, Pome, Group 11-10; Fruit, Small Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13-07F; Berry, Low Growing, Subgroup 13-07G; Vegetable, Fruiting, Group 8-10; Greenhouse Tomato; Fruit, Citrus, Group 10-10; Fruit, Stone, Group 12-12; and Nut, Tree, Group 14-12; and Various Tropical Fruits.," PC Code:  122804, Decision No.:  480177, 495169, 495170, 478520, 476238, DP Barcode:  D426599, dated April 18, 2016.

C. Aggregate Exposure

	1. Dietary exposure. Tier IV acute, short-term, and chronic aggregate exposure evaluations were made for abamectin using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCIDTM , version 4.02), which incorporates food consumption data from the National Health and Nutrition Examination Survey/"What We Eat in America" (NHANES/WWEIA) dietary survey conducted in 2005-2010.  These assessments included all current as well as a number of proposed new uses and revised crop groupings on legumes (Crop Group 6), blueberries (post-harvest, non-food), carrot (seed treatment), imported tea, and imported bananas.  Residue data were obtained from field trial residue studies in which abamectin was applied at the maximum intended use rate and samples were harvested at the minimum pre-harvest interval (PHI) to obtain maximum residue values.  Drinking water estimates were incorporated directly into the dietary exposure assessment using the higher of the estimated drinking water concentrations (EDWCs) for surface and ground water.  Empirical processing factors were used for cottonseed oil (0.48x), grape juice (0.23x), grape raisins (0.75x), grapefruit juice (0.85x), orange juice (0.25x), orange peel (2.5x), dried prune (3.9x), tomato paste (0.84x), tomato puree (0.4x), field corn flour (1.96x), and papaya pulp (0.35x).  Percent crop treated values were taken from the EPAs April 14, 2016 acute and chronic dietary assessments (D424009, D421348).  Residue values for in the meat, milk, and eggs of livestock were calculated using the "maximum reasonably balanced diet" (MRBD) dietary burden approach in conjunction with transfer factors obtained from livestock feeding and/or metabolism studies.  In addition to dietary sources of abamectin, beef and/or dairy cattle may be exposed to abamectin via impregnated ear tags.  In order to account for residues of abamectin in milk from either or both of these sources, an approach was developed to combine dietary abamectin residues with additional ear tag abamectin residues in a refined probabilistic dietary risk assessment.  For poultry, the EPA has determined that secondary residues are not anticipated.  For swine, MRBDs constructed in the usual manner were used in conjunction with transfer factors from a dairy feeding study to predict residues in hog meat.

	i. Food Acute Exposure.  The abamectin acute dietary (food only) risk assessment was performed for all population subgroups with an acute reference dose of 0.0025 mg/kg-bw/day based on sub-chronic and chronic oral toxicity studies in dogs with a No Observed Adverse Effect Level (NOAEL) of 0.25 mg/kg-bw/day and an uncertainty factor of 100X.  The 100-fold safety factor includes intra- and interspecies variations; no additional FQPA safety factors were included in these assessments.  For the purpose of the aggregate risk assessment, exposure values were expressed in terms of margin of exposure (MOE), which was calculated by dividing the NOAEL by the exposure for each population subgroup.  In addition, exposure was also expressed as a percentage of the acute reference dose (%aRfD).  Acute (food only) exposure to the U.S. population resulted in a MOE of 395 (25.3% of the acute RfD of 0.0025 mg/kg-bw/day).  The most sensitive sub-population was children (1-2 years old) with a MOE of 178 (56.0% of the aRfD).  Since the Benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures above the benchmark or below 100% of the reference dose, Syngenta believes that there is a reasonable certainty that no harm will result from acute food exposure to residues arising from all current and proposed uses for abamectin.

Chronic Exposure.  The abamectin chronic dietary (food only) risk assessment was performed for all population subgroups with a chronic reference dose of 0.0025 mg/kg-bw/day based on sub-chronic and chronic oral toxicity studies in dogs with a No Observed Adverse Effect Level (NOAEL) of 0.25 mg/kg-bw/day and an uncertainty factor of 100X.  The 100-fold safety factor includes intra- and interspecies variations; no additional FQPA safety factors were included in these assessments.  For the purpose of the aggregate risk assessment, exposure values were expressed in terms of margin of exposure (MOE), which was calculated by dividing the NOAEL by the exposure for each population subgroup.  In addition, exposure was also expressed as a percent of the chronic reference dose (%RfD).  Chronic (food only) exposure to the U.S. population resulted in a MOE of 9,907 (1.0% of the chronic RfD of 0.0025 mg/kg-bw/day).  The most sensitive sub-population was children (1-2 years old) with a MOE of 2,210 (4.5% of the chronic RfD).  Since the Benchmark MOE for this assessment was 100 and since the EPA generally has no concern for exposures above the benchmark or below 100% of the reference dose, Syngenta believes that there is a reasonable certainty that no harm will result from chronic food exposure to residues arising from all current and proposed uses for abamectin.

Cancer.  Abamectin is considered "not likely to be a human carcinogen".  Therefore, no cancer risk assessment was performed for abamectin.

	ii. Drinking water. The residues of concern in drinking water include abamectin (avermectin B1a and B1b), NOA448111 (8a-oxo-avermectin B1a), NOA448112 (8a-hydroxy-avermectin B1a), NOA426289 (4-oxo-avermectin B1a), NOA445495 (3-demethyl-avermectin B1a), NOA457464, and NOA457465. This mixture is referred to as abamectin TTR (total toxic residue).The estimated drinking water concentrations (EDWCs) of abamectin TTR were derived from the Pesticide Water Calculator (PWC, v1.52) graphical user interface which incorporates the Pesticide Root Zone Model/Variable Volume Water Model (PRZM/VVWM) Tier II surface water and Tier I PRZM ground water modelling platforms. Simulations were conducted to determine the highest EDWCs resulting from current labelled uses as well as proposed foliar uses on bulb and green onions, legume vegetables, and seed treatment for carrots.  PWC ground water modelling for golf course turf (tees, greens, and fairways) provided the highest acute EDWC of 0.105 ppb.  A chronic EDWC could not be determined because the model predicted incomplete breakthrough over the 100-yr. simulation.  Therefore, the chronic EDWC was derived from the SCI-GROW model (v 2.3) which predicted an EDWC of 0.00355 ppb. Tier II PWC surface water modelling of golf course turf (tees, greens, and fairways) provided the highest acute and chronic EDWCs of 1.85 ppb and 0.814 ppb, respectively.  Surface water EDWCs were not adjusted for Percent Cropped Area (PCA) factor.  Since surface water EDWCs exceed the ground water EDWCs, surface water concentrations were used for risk assessment purposes and will be considered protective for any ground water exposure concerns.

Acute Exposure from Drinking Water.  The acute surface water EDWC of 1.85 ppb was input directly into the DEEM-FCID(TM) software as "water, direct and indirect, all sources" to model the acute drinking water exposures. Drinking water exposures at the 99.9[th] percentile were determined by taking the difference between the aggregate exposures (food + drinking water) and food exposures (food only) for each population subgroup.  Acute drinking water exposure to the U.S. population resulted in a drinking water MOE of 4,630 (2.2% of the aRfD of 0.0025 mg/kg-bw/day).  The most sensitive sub-population was females 13-49 years old, with a drinking water MOE of 2,688 (3.7% of the aRfD of 0.0025 mg/kg-bw/day).  Since the benchmark MOE for this assessment is 100 and since EPA generally has no concern for exposures above the benchmark or below 100% of the aRfD, Syngenta believes that there is a reasonable certainty that no harm will result from acute drinking water exposures to residues arising from all current and proposed uses of abamectin.

Chronic Exposure from Drinking Water.  The chronic surface water EDWC of 0.814 ppb was input directly into the DEEM-FCID(TM) software as "water, direct and indirect, all sources" to model the chronic drinking water exposures.  Chronic drinking water exposure to the U.S. population resulted in a drinking water MOE of 15,201 (0.7% of the cRfD of 0.0025 mg/kg-bw/day).  The most sensitive sub-population was infants <1 year old, with a drinking water MOE of 4,069 (2.5% of the cRfD of 0.0025 mg/kg-bw/day).  Since the Benchmark MOE for this assessment was 100 and since EPA generally has no concern for exposures above the benchmark or below 100% of the cRfD, Syngenta believes that there is a reasonable certainty that no harm will result from chronic drinking water exposure to residues arising from all current and proposed uses of abamectin.

D. Cumulative Effects

	Section 408(b)(2)(D)(v) of the Federal Food, Drug, and Cosmetic Act (FFDCA) requires EPA to consider available evidence concerning the cumulative effects of pesticide residues and other substances that have a common mechanism of toxicity (i.e., a common toxic effect to human health by the same, or essentially the same, sequence of major biochemical events).  The agency determined in its April 18, 2016 human health risk assessments (D426599) that abamectin and emamectin benzoate form a candidate common mechanism group (CMG) for the avermectin macrocyclic lactones.  Syngenta conducted screening-level acute, short-term, and chronic cumulative exposure analyses for the avermectin macrocyclic lactones abamectin and emamectin benzoate using the screening framework outlined in the Pesticide Cumulative Risk Assessment: Framework for Screening Analysis Purpose (USEPA, 2016). These screening-level assessments evaluate combined exposures of abamectin and emamectin, and are therefore an overestimate of exposure and risk since they assume a complete co-occurrence of residues of abamectin and emamectin from food, drinking water, and residential sources.

The cumulative abamectin and emamectin cumulative assessments were performed for all population subgroups with acute and chronic reference doses of 0.0025 mg/kg-bw/day, based on oral toxicity studies in dogs with a NOAEL of 0.25 mg/kg-bw/day and an uncertainty factor of 100X.  The 100-fold safety factor includes intra- and interspecies variations.  The short-term cumulative assessments utilized the same NOAEL of 0.25 mg/kg-bw/day and an uncertainty factor of 100X (LOC = 100).

In the acute cumulative assessments, exposures for the U.S. population resulted in a cumulative acute MOE of 273 (36.7% of the aRfD of 0.0025 mg/kg-bw/day).  The most sensitive sub-population was children (1-2 years old) with a cumulative acute MOE of 138 (72.2% of the aRfD).  In the short-term cumulative assessments, exposures for the U.S. population resulted in a cumulative short-term MOE of 3,095 (Level of Concern = 100).  The most sensitive sub-population was children 1-2 years old with a cumulative short-term MOE of 1,559 (Level of Concern = 100).  In the chronic cumulative assessments, exposures for the U.S. population resulted in a cumulative chronic MOE of 4,717 (2.1% of the cRfD of 0.0025 mg/kg-bw/day).  The most sensitive sub-population was children 1-2 years old with a cumulative chronic MOE of 1,563 (6.4% of the cRfD).  These screening-level cumulative aggregate acute, short-term, and chronic assessment indicate that cumulative exposures for abamectin and emamectin benzoate are below the Agency's level of concern.

E. Safety Determination

	1. U.S. population. The acute dietary exposure analysis (food plus drinking water) showed that exposure from all current and proposed abamectin crop uses result in a MOE of 364 (27.5% of the aRfD, Benchmark MOE = 100) for the general U.S. population.  The short-term exposure analysis (food plus drinking water plus residential) showed that exposure from all current and proposed abamectin uses result in a MOE of 3,635 (Benchmark MOE = 100) for the general U.S. population.  The chronic dietary exposure analysis (food plus drinking water) showed that exposure from all current and proposed abamectin crop uses result in a MOE of 5,998 (1.7% of the cRfD, Benchmark MOE = 100) for the general U.S. population.  Based on the completeness and reliability of the toxicity data supporting these uses, Syngenta believes that there is a reasonable certainty that no harm will result to the general U.S. population from aggregate exposure to residues arising from all current proposed abamectin uses, including anticipated dietary exposure from food, water, and all other types of non-occupational residential exposures.

	2. Infants and children. The acute dietary exposure analysis (food plus drinking water) showed that exposure from all current and proposed abamectin uses results in a MOE of 169 (59.0% of the aRfD) for children 1-2 years old (the most sensitive population subgroup).  For the short-term aggregate assessments, children 1-2 years old had an aggregate MOE of 1,834 (Benchmark MOE = 100) for all current and proposed abamectin uses.  The chronic dietary exposure analysis (food plus drinking water) showed that exposure from all current and proposed abamectin uses result in a MOE of 1,842 (5.4% of the cRfD) for children 1-2 years old (the most sensitive population subgroup).  Based on the completeness and reliability of the toxicity data supporting these uses, Syngenta believes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to residues arising from all current and proposed abamectin uses, including anticipated dietary exposure from food, water, and all other types of non-occupational residential exposures.

F. International Tolerances

Codex has established Maximum Residue Levels (MRLs) for abamectin on commodities including almond hulls, avocado, beans, blackberries, celery, cherries, citrus fruits, cotton seed, cucumber, dried grapes, eggplant, garlic, gherkin, grape juice, grapes, hops, leek, lettuce, mango, melons, onions, papaya, peaches, peanut, peppers, plums, pome fruits, potato, raspberries, rice, shallots, strawberries, sweet potato, tomato, tree nuts, and yams.


1 MEMORANDUM DATE: March 27, 2003 SUBJECT: Summary of Information Related to Clean Air Act Exemptions for Radioactive Mixed Wastes TO: Elaine Manning and Greg Nizich,

U. S. Environmental Protection Agency ( EPA) Office of Air Quality Planning and Standards ( OAQPS) Emissions Standards Division ( ESD)

FROM: Robert Zerbonia, Research Triangle Institute ( RTI)

I. Origin of the Mixed Waste Exemption The origin of the exemption of waste management units handling radioactive mixed waste ( RMW) from using air emission controls under the off site waste and recovery operations ( OSWRO) and site remediation National Emission Standards for Hazardous Air Pollutants ( NESHAP) traces back to the Resource Conservation and Recovery Act ( RCRA) subpart CC rules under parts 264 and 265 promulgated on December 6, 1994. These rules established air emission control requirements for treatment, storage and disposal facilities ( TSDF) tanks, surface impoundments, and containers ( see 59 FR 62896). Specifically, the preamble for this rulemaking states that the U. S. Environmental Protection Agency ( EPA) decided to defer application of the RCRA subpart CC standards to waste management units used solely to manage radioactive mixed waste ( see page 62897, third column). A rationale for the exemption is presented in Section VII. 1. d ( see page 62914, bottom first column). The technical argument of unsafe build up of hydrogen gas in drums with leak tight covers is presented. The preamble discussion concludes with the statement that EPA is planning to further investigate methods for controlling organic emission from these sources consistent with safe practices for handling radioactive wastes.

The proposed OSWRO NESHAP did not include the radioactive mixed waste exemption. However, promulgation of the RCRA subpart CC rules occurred during the public comment period for the proposed OSWRO NESHAP. Because many sources at hazardous waste TSDF were expected to be subject to both rules and given the need to avoid establishing conflicting requirements on these sources under these rules, EPA made the requirements of the RCRA subpart CC rules and OSWRO NESHAP consistent ( to the fullest extent allowable within the authorities of RCRA and Clean Air Act section 112). Consequently, EPA added the radioactive mixed waste exemption in the final OSWRO NESHAP ( promulgated July 1, 1996) to be 2 consistent with the final RCRA subpart CC rules. Later, the proposed Site Remediation NESHAP adopted the exemption to be consistent with the OSWRO NESHAP.

II. Original RCRA Air Rules Rationale On July 22, 1991, EPA published the proposed rule for " Hazardous Waste Treatment, Storage and Disposal Facilities: Organic Air Emissions Standards for Tanks, Surface Impoundments, and Containers ( RCRA Subpart CC, 56 FR 33491). The Department of Energy ( DOE) provided comments to EPA on October 21, 1991. ( see " Department of Energy Comments on Organic Air Emissions Standards for Tanks, surface Impoundments, and containers at Hazardous Waste Treatment, Storage and Disposal Facilities Proposed Rule ( July 22, 1991, 56 FR 33490)" and EH 231 Memorandum dated 12/ 09/ 91, Subject " Consolidated Department of Energy ( DOE) Response to VOC Organic Air Emissions Standards for Tanks, Surface Impoundments, and Containers; Proposed Rule." ( See RCRA Docket Item F 91 CESP 00046.)

The DOE provided detailed comments on issues of concern to the Department, particularly the unique problems associated with the management of radioactive mixed wastes. In its comments DOE stated that the issue of radioactive mixed wastes was " of utmost concern" because the requirements of the proposed rule did not take into consideration the unique problems associated with the management of radioactive mixed wastes ( DOE Comments, p. 3). They state that this type of waste warrants special consideration because it poses unique hazards and handling difficulties not encountered with non radioactive hazardous wastes. This issue was especially significant to DOE because large quantities of radioactive mixed wastes are generated and stored for future treatment and/ or disposal at DOE facilities. They contended that if required to comply with the proposed rule, DOE workers would face potential exposure to radiation as a result of increased inspection and sampling of these wastes.

Additionally, DOE noted that the requirement for leak tight covers on containers in the proposed rule would increase the potential for explosions due to the buildup of hydrogen gas in drums and containers of radioactive mixed wastes. ( DOE Comments, p. 3) They further stated that an explosion involving radioactive and hazardous wastes would be extremely hazardous to personnel managing the drums and containers.

Related communication and correspondence regarding this issue followed as the final RCRA rules were developed ( e. g., Deputy Assistant Secretary for Environment, R. P. Berube's July 13, 1994, letter which discussed the concerns about the applicability of the RCRA rule to DOE's radioactive mixed wastes, and the Director of EPA's Office of Solid Waste, M. K. Shapiro's September 2,1994, response; RCRA Docket Items F 94 CESF S0001 and F 94 CESF S0003, respectively).

In the final RCRA Air Rules, EPA decided to temporarily defer application of the subpart CC standards to waste management units used solely to manage radioactive mixed wastes ( 59 FR 62897). The rationale for the deferral that appeared in the preamble is as follows.

  Section III. F. Relationship to Nuclear Regulatory Commission Standards  3   Radioactive mixed wastes are wastes that contain radioactive materials as well as materials listed or identified as hazardous under RCRA. Radioactive mixed wastes must be managed in accordance with RCRA regulations, in addition, these wastes also are subject to standards administered by the Nuclear Regulatory Commission ( NRC) under the Atomic Energy Act and Nuclear Waste Policy Act of 1982 that address the safe handling and disposal of radioactive waste.

  The EPA has previously stated its general position that the management of radioactive mixed waste at TSDF is subject to regulation under subtitle C of RCRA ( 51 FR 24504, July 3, 1986; 53 FR 37045, September 23, 1988). In developing the RCRA standards applicable to radioactive mixed wastes, the EPA considers the management practices required for these wastes to avoid inconsistencies between the EPA's hazardous waste management requirements and the NRC's radioactive waste management requirements. Furthermore, RCRA section 1006( a) precludes any solid or hazardous waste regulation by the EPA or a State that is   inconsistent  with the requirements of the Atomic Energy Act. Thus, in a case where the regulatory requirements for radioactive mixed waste are conflicting, the NRC requirement takes precedence over the RCRA requirement. Because of the potential that air emission control equipment required by the subpart CC standards promulgated today may conflict with certain radioactive waste management requirements under NRC standards, the EPA has decided to temporarily defer application of the subpart CC standards to tanks, containers, and surface impoundments which are being used solely to manage radioactive mixed wastes. This deferral is discussed further in section VII. A. 1. d of this preamble.

*****   Section VII. A. 1. d. Radioactive mixed wastes.

  As explained in section III. F of this preamble, the management of radioactive mixed waste at TSDF is subject to regulation under subtitle C of RCRA. The EPA reviewed the special nature of radioactive mixed wastes with respect to the air emission control requirements under the final subpart CC standards. In certain cases, the air emission controls used as the basis for the subpart CC standards are not compatible with the NRC requirements for safe handling of radioactive mixed wastes. For example, drums used to store radioactive mixed waste cannot be sealed with vapor leak tight covers because of unacceptable pressure buildup of hydrogen gas to levels that can potentially cause rupture of the drum or create a potentially serious explosion hazard. This generation of hydrogen gas results from the radiolytic decomposition of organic materials ( e. g., plastics) or aqueous solutions stored in the drums. Consequently, a drum used for storage of radioactive mixed wastes must be continuously vented through special filters in accordance with technical guidance issued by the NRC to prevent the hydrogen 4 concentration in the drum from reaching dangerous levels. The EPA is planning to further investigate methods for effective control of organic emissions from waste management units handling radioactive mixed waste that are consistent with the NRC waste management practices.

III. Mixed Waste Background Information Persons who generate, treat, store or dispose of mixed wastes are subject to the requirements of the Atomic Energy Act of 1954 ( AEA), as amended and the Solid Waste Disposal Act ( SWDA) as amended by the RCRA, and the Hazardous and Solid Waste Amendments of 1984 ( HSWA). The Federal agencies responsible for ensuring compliance with the implementing regulations of these two statutes are the Nuclear Regulatory Commission ( NRC) and the EPA. In October 1992, Congress enacted the Federal Facilities Compliance Act ( FFCA) which, among other things, added a definition of mixed waste to RCRA. Mixed waste is defined in the FFCA as " waste that contains both hazardous waste and source, special nuclear, or byproduct material subject to the Atomic Energy Act of 1954" ( RCRA 1004( 41), 42 USC 6903( 41)).

Under the dual regulatory framework that exists for mixed waste, the EPA or authorized States regulate the hazardous waste and the NRC, NRC agreement States, or the DOE regulate the radioactive waste. The NRC generally regulates commercial and non DOE federal facilities. DOE is currently self regulating and its orders apply to DOE sites and contractors. Once a waste is determined to be a mixed waste, the waste handlers must comply with both AEA and RCRA statutes and regulations. The requirements of RCRA and AEA are generally consistent and compatible. However, the provisions in Section 1006( a) of RCRA allow the AEA to take precedence in the event provisions of requirements of the two acts are found to be inconsistent.

Almost all of the commercially generated ( non DOE) mixed waste is composed of Low Level Radioactive Waste ( LLRW) and Hazardous Waste and is called Low Level Mixed Waste ( LLMW). Mixed low level radioactive and hazardous waste ( mixed waste) is waste that satisfies the definition of low level radioactive waste in the Low Level Radioactive Waste Policy Amendments Act of 1985 ( LLRWPAA) and contains hazardous waste that either: 1) is listed as a hazardous waste in Subpart D of 40 CFR Part 261; or 2) causes the waste to exhibit any of the hazardous waste characteristics identified in Subpart C of 40 CFR Part 261. Commercially generated LLMW is produced in all 50 states at industrial, hospital, and nuclear power plant facilities. Radioactive and hazardous materials are used in a number of processes such as medical diagnostic testing and research, pharmaceutical and biotechnology development, pesticide research, as well as nuclear power plant operations. Based on the results of a survey conducted by NRC & EPA ( NUREG/ CR 5938), approximately 4,000 m3 of LLMW were generated in the U. S. in 1990. Of this amount, organic solvents such as chlorofluorocarbons ( CFC's), corrosive organics, and waste oil made up 18%, toxic metals made up 3%.

There are three main types of mixed waste being produced or stored at DOE facilities: Low Level, High Level, and Transuranic. 5 DOE LLMW is generated, projected to be generated, or stored, at 37 DOE sites in 22 states as a result of research, development, and production of nuclear weapons.

DOE High Level Waste ( HLW) is radioactive waste resulting from reprocessing spent nuclear fuel and irradiated targets from reactors and is liquid before it is treated. Some of its elements will remain radioactive for thousands of years. HLW is also a mixed waste because it has highly corrosive components or has organics or heavy metals that are regulated under RCRA. DOE has about 399,000 m3 of HLW stored in large tanks at four locations: Hanford, Washington; Idaho National Engineering Laboratories ( INEL), Idaho; Savannah River Site ( SRS), South Carolina; and the West Valley Demonstration Project, New York.

DOE Mixed Transuranic Waste ( MTRU) is waste that has a hazardous component and radioactive elements heavier than Uranium. MTRU is primarily generated from nuclear weapons fabrication, Plutonium bearing reactor fuel fabrication, and spent fuel reprocessing. MTRU is currently being treated and stored at six DOE sites: Hanford, ( 3,000 m3); INEL ( 38,000 m3); Los Alamos National Laboratories, New Mexico ( 8,000 m3); Rocky Flats, Colorado ( 1,500 m3); Oak Ridge National Laboratories, Tennessee ( 1,500 m3); SRS ( 5,000 m3). ( See " About Mixed Waste," www. epa. gov/ radiation/ mixed waste/ mw_ pg3. htm.)

IV. Generation of Hydrogen Gas The generation of hydrogen gas is a result of the radiolytic decomposition of organic compounds ( i. e., plastics) and/ or aqueous solutions within the container. Plastics are commonly used as a barrier to alpha radiation both in handling operations and in waste packaging. Over time, the alpha particle causes the hydrolysis of chemical bonds within the plastic material which results in the release of hydrogen gas. Likewise, hydrolysis of aqueous solutions will yield hydrogen. Additionally, radiation induced degradation and biodegradation of organic low exchange resin waste, which are also RMW, generated during water treatment at nuclear facilities, can result in the production of gaseous products ( i. e., hydrogen and carbon dioxide) which can result in pressure buildup and failure of the container. High integrity containers are used as an alternative to solidification as a means of stabilizing ion exchange resin wastes for disposal.

Because of pressure build up inside the container, a vent for gaseous compounds may be necessary to prevent failure of a high integrity container ( i. e., vent designs incorporated into high integrity containers restrict the release of radionuclides from the container into the environment while allowing the gas to be vented). ( See P. L. Picilo, Technical Considerations for Highintegrity Containers for Disposal of Radioactive Ion Exchange Reside Waste, United States Nuclear Regulatory Commission, NUREGCR 3163, p. 75, October 1992).

V. DOE Container Requirements Numerous DOE nuclear facilities produce and store a variety of RMW, including MTRU. Since 1970, MTRU wastes have been packed in drums for temporary storage at certain DOE sites. Much of this waste is ultimately destined for final disposal/ storage at the Waste Isolation Pilot 6 Plant ( WIPP), Carlsbad, New Mexico. In accordance with the WIPP Waste Acceptance Plan ( WAP), wastes that are to be shipped to the WIPP must be in containers that are vented to prevent the buildup of pressure. The vents must be filtered to ensure that no radioactive waste components are released. For example, the RCRA Hazardous Waste Permit for the WIPP, dated November 25, 2002, in section M1 1d Container Management Practices, Page M1 8, states: " Because containers at the WIPP will contain radioactive waste, safety concerns require that containers be continuously vented to obviate the buildup of gases within the container. These gases could result from radiolysis, which is the breakdown of moisture by radiation. The vents, which are nominally 0.75 in. ( 1.9 centimeters) in diameter, are generally installed on or near the lids of the containers. These vents are filtered so that gas can escape while particulates are retained." In addition on Page M1 2 of the Permit, Standard 55 Gallon Drums in describing the requirements for the standard TRU mixed waste drums, the Permit states: " One or more filtered vents ( as described in Section M1 1d) will be installed in the drum lid to prevent the escape of any radioactive particulates and to eliminate any potential of pressurization."

In order to comply with these requirements at the Idaho National Laboratory Drum Vent Facility, the drum lid is punctured to release any buildup of potentially explosive hydrogen gas and a NUCFIL filter vent is attached. The function of a NUCFIL filter vent is to retain radionuclides inside a container while allowing hydrogen and other gases ( e. g., VOC) to pass through to the atmosphere. In particular, the carbon composite membrane used in the filter vent does not inhibit the passing of VOC's from the container into the atmosphere. ( See Deputy Assistant Secretary for Environment, R. P. Berube's July 13, 1994, letter which discussed the concerns about the applicability of the RCRA rule to DOE's radioactive mixed wastes, RCRA Docket Item F 94 CESF S0001.)

It is also of interest to note that the WIPP RCRA Permit, in Sections N 1, 2, and 3 ( and elsewhere) acknowledges the potential for VOC emissions from the mixed waste canisters. The permit requires a VOC monitoring plan be developed and VOC monitored to confirm that the annual average concentrations of VOC in the air emissions from the Underground HWDUs do not exceed the " VOC concentrations of concern ( COC)" which are listed in an attached table. The target VOC constituents ( organic solvents) were selected because together they represent approximately 99 percent of the risk due to air emissions.

Because it was judged an unsafe practice to store RMW drums with tight covers, and because the WIPP WAP requires that containers be vented for shipment to the WIPP, the EPA determined that many DOE facilities may be unable to meet the tight cover control device criteria as specified in the proposed RCRA Air Rules. In addition, the Agency was unable to determine, at that time, if there were any available technologies that could be applied to the RMW containers that would control organic air emissions in a safe and cost effective manner while also complying with WIPP and other AEA and NWPA requirements.

VI. Other Mixed Waste Management Units The exemption for radioactive mixed wastes in the proposed Site Remediation NESHAP rule at 7 § 63.7882( c)( 7) is a broad based exemption that extends to all site remediation materials regardless of the type of treatment or management unit. This is consistent with the OSWRO NESHAP and with the RCRA air rules in Subpart CC, in Parts 264 and 265. However, the RCRA air rules for process vents and equipment leaks in Subparts AA and BB, Parts 264 and 265, do not exempt radioactive mixed wastes.

Although the available technical information and data provide a strong basis for extending the exemption to radioactive mixed waste remediation material management units such as tanks, surface impoundments, and containers ( i. e., the Subpart CC units), it appears that this is not the case for process vents and equipment leaks ( i. e., the Subpart AA and BB sources). The technical and safety concerns relative to tanks and containers are not an issue with the treatment units and equipment components that are affected by the subpart AA and BB rules. There are no incompatible requirements as is the case with tanks and containers. It has also been shown that, since going into effect in 1990, remediation material streams that are classified as radioactive mixed wastes have been subject to and / or in compliance with the Subpart AA and BB RCRA air rules for process vents and equipment leaks. For example, the Idaho National Engineering and Environmental Laboratory ( INEEL)' s Test Area North has a groundwater plume that is contaminated with organic compounds ( i. e., TCE, DCE, and PCE) and radionuclides ( i. e., strontium 90, tritium, and cesium 137). Based on a CERCLA record of decision ( ROD), which was issued in August 1995, the remedy implemented included groundwater extraction and then treating the extracted groundwater by air stripping followed by vapor carbon adsorption to control organic air emissions. This radioactive mixed waste treatment system was required to comply with all applicable relevant and appropriate regulations ( ARARs), that included 40 CFR Part 264, Subpart AA.

VII. Current Situation ! Information gathered and reviewed for the preparation of this memo does not give any indication that the situation regarding the safety issue related to storage of RMW has changed since EPA promulgated the RCRA Air Rules. The potentially conflicting requirements for containers to be vented under one set of rules versus the requirements for closed, tight fitting covers under the RCRA/ CAA rules remains to be resolved.

! No available technologies have been identified that could be applied to the RMW containers that would control organic air emissions in a safe and cost effective manner while also complying with WIPP and other AEA and NWPA requirements. The MACT Floor for RMW source appears to be no control.

! Study could be given to examine the feasibility of controlling organic air emission by adapting the RMW particulate filters to include some form of adsorbent ( e. g., activated carbon) to reduce organic air emissions. No such technology appears to be in use for this particular situation currently. In addition, the feasibility ( technical performance and cost) of venting the RMW container storage room or building air to a control device also could be examined. 8 ! Containers meeting the RMW ( e. g., TRIPACT II) specifications are required to install filters to capture radiation in decay gases vented from the container's contents over time. Although the containers ( and associated filters) do not capture and control VOC during above ground storage, it is believed that the NRC requirements can provide sufficient control of VOC vented from mixed waste containers after disposal. ( See attached RTI memo from Deerhake and Zerbonia, dated March 27,2003)

! NRC siting, operation, and post closure standards for waste storage and disposal are oriented toward protection from human exposure to radiation. Consequently, it is believed that those NRC regulations provide similar protection from exposure to volatile organic emissions.


	                   UNITED STATES OF AMERICA

            DEPARTMENT OF TRANSPORTATION

                    OFFICE OF THE SECRETARY

                             WASHINGTON, DC

Docket OST-2005-20459

								Docket OST-2005-20630

NOTICE ON PROCEDURES AND

CONSOLIDATION OF EXEMPTION APPLICATIONS

Under the U.S.-Mexico aviation agreement, the United States may
designate up to two U.S. carriers to provide direct-carrier (own
aircraft) combination services in a given U.S.-Mexico city-pair market.
Brendan Airways, LLC, d/b/a USA 3000 Airlines (USA 3000) and United Air
Lines, Inc. (United) each has filed an application for an exemption to
serve the Chicago-San Jose del Cabo city-pair market.  Currently,
American Airlines, Inc., holds underlying authority and is designated to
serve the route, leaving only one designation opportunity available in
this market.

A number of responsive pleadings have been filed to the applications.
The record effectively stands ready for decision and, in the
circumstances presented, including the fact that these valuable
bilateral rights are now unused, we intend to proceed directly to a
final order on this matter.  However, we believe that the applicants
should be accorded one further opportunity to add information to the
record to ensure its completeness before our final decision.

In awarding the available authority, our principal objective will be to
maximize public benefits that will result from award of the authority in
this case.  In this regard, we will consider which applicant will most
likely offer and maintain service that best meets the needs of the
traveling and shipping public.  We will also consider the effects of the
applicants’ service proposals on the overall competitive environment,
including effects on the market structure and the level of competition
in the Chicago-San Jose del Cabo market, the U.S.-Mexico market, and on
any other markets shown to be relevant.  In addition, we will consider
other factors historically used for carrier selection, where they are
relevant.

We intend to issue Chicago-San Jose del Cabo exemption authority for a
two-year period, subject to a 90-day startup condition, and subject also
to certain dormancy notice requirements routinely imposed on U.S.-Mexico
air transportation services.  Except where service in the market is
seasonal/intermittent in nature, the dormancy conditions will apply as
specified above.  In light of the U.S.-Mexico dormancy conditions, and
consistent with our standard policy, we will only grant Chicago-San Jose
del Cabo route authority to an applicant presenting firm service plans.

As indicated above, we intend to resolve issues on the basis of the
pleadings filed, and to award the immediately-available Chicago-San Jose
del Cabo authority by proceeding directly to final order.  As the
applications filed are already ripe, and all interested parties have had
an opportunity to file competing requests, we will not provide for
additional applications here.

Therefore, acting under authority assigned in 14 CFR 385.3, we will give
USA 3000 and United an opportunity to file any other pertinent
information to support their Chicago-San Jose del Cabo applications.
The additional information should be filed no later than

five (5) business days from the date of service of this Notice, and
should be served on all parties in the captioned docket.

We will serve this notice by electronic mail on all parties to this
proceeding.  We authorize service of documents by facsimile and by
electronic mail.

By:

					PAUL L. GRETCH

Director, Office of International Aviation

(SEAL)

Dated:  May 3, 2005

An electronic version of this notice is available on the World Wide Web
at:

  HYPERLINK "http://dms.dot.gov//reports/reports_ aviation.asp"
http://dms.dot.gov//reports/reports_ aviation.asp

 USA 3000 proposes to serve the Chicago-San Jose del Cabo market on a
year-round basis with one-weekly flight, beginning May 6, 2005, and
United proposes year-round service with two-weekly flights from May 7,
2005,  to October 31, 2005, and with four-weekly flights from November
1, 2005,  to

April 30, 2006.

 On March 9, 2005, United filed an answer to USA 3000’s application,
along with a motion to consolidate the applications for contemporaneous
consideration.  We will grant the motion.  On April 6, 2005, the City of
Chicago filed a reply in support of United’s application in Docket
OST-2005-20630.  It accompanied the reply with a motion for leave to
file an otherwise unauthorized document.  We will grant the motion.

 Both carriers have requested that the Department institute a carrier
selection proceeding.  United has urged the Department to streamline the
carrier selection process as was done in a recent carrier selection case
involving service in the Milwaukee-Cancun market (see Notice on
Procedures dated January 7, 2005, in Dockets OST-2004-19806 and
OST-2004-19887).

Application of

    United Air Lines, Inc.

for an exemption pursuant to 49 U.S.C. Section 40109

(Chicago-San Jose del Cabo)

Application of

  Brendan Airways, LLC d/b/a USA 3000 Airlines

for an exemption pursuant to 49 U.S.C. Section 40109

(Chicago-San Jose del Cabo)

2005 Chicago-San Jose del Cabo Exemption Proceeding

Docket OST-2005-21156


[Federal Register Volume 80, Number 94 (Friday, May 15, 2015)]
[Notices]
[Pages 27945-27946]
[FR Doc No: 2015-11692]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2629-000]

Village of Morrisville, Vermont; Notice of Authorization for
Continued Project Operation

    On April 25, 2013 the Village of Morrisville (Vermont), licensee
for the Morrisville Hydroelectric Project, filed an Application for a
New License

pursuant to the Federal Power Act (FPA) and the Commission's
regulations thereunder. The Morrisville Hydroelectric Project is
located on Green River, Elmore Pond Brook, and Lamoille River in
Lamoille County, Vermont.
    The license for Project No. 2629 was issued for a period ending
April 30, 2015. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1),
requires the Commission, at the expiration of a license term, to issue
from year-to-year an annual license to the then licensee under the
terms and conditions of the prior license until a new license is
issued, or the project is otherwise disposed of as provided in section
15 or any other applicable section of the FPA. If the project's prior
license waived the applicability of section 15 of the FPA, then, based
on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c),
and as set forth at 18 CFR 16.21(a), if the licensee of such project
has filed an application for a subsequent license, the licensee may
continue to operate the project in accordance with the terms and
conditions of the license after the minor or minor part license
expires, until the Commission acts on its application. If the licensee
of such a project has not filed an application for a subsequent
license, then it may be required, pursuant to 18 CFR 16.21(b), to
continue project operations until the Commission issues someone else a
license for the project or otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 2629 is issued to
the licensee for a period effective May 1, 2015 through April 30, 2016
or until the issuance of a new license for the project or other
disposition under the FPA, whichever comes first. If issuance of a new
license (or other disposition) does not take place on or before April
30, 2016, notice is hereby given that, pursuant to 18 CFR 16.18(c), an
annual license under section 15(a)(1) of the FPA is renewed
automatically without further order or notice by the Commission, unless
the Commission orders otherwise. If the project is not subject to
section 15 of the FPA, notice is hereby given that the licensee, the
Village of Morrisville (Vermont), is authorized to continue operation
of the Morrisville Hydroelectric Project, until such time as the
Commission acts on its application for a subsequent license.

    Dated: May 8, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-11692 Filed 5-14-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Notices]
[Pages 14402-14403]
[FR Doc No: 2012-5777]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0085]

Draft Guidance on Classifying Significant Postmarket Drug Safety
Issues; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Classifying Significant
Postmarket Drug Safety Issues.'' This draft guidance describes FDA's
current approach to classifying a significant postmarket drug safety
issue as a ``priority'' tracked safety issue (TSI) or a ``standard''
TSI, with the capability of elevating some priority TSIs to an
``emergency'' status. The draft guidance was developed in connection
with the Center for Drug Evaluation and Research's (CDER's) Safety
First Initiative.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 8, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Michie Hunt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6153, Silver Spring, MD 20993-0002, 301-
796-3504.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled
``Classifying Significant Postmarket Drug Safety Issues.'' This draft
guidance describes CDER's current approach to determining whether a
significant postmarket drug safety issue should be classified as a
``priority,'' as a ``standard,'' or as an ``emergency'' tracked safety
issue (TSI).
    CDER receives a constant flow of information about potential drug
safety issues, and the seriousness of reported problems varies widely.
Those that CDER determines to be significant safety issues are tracked
in the Center's Document Archiving, Reporting, and Regulatory Tracking
System (DARRTS), a centralized data base that enables staff working
across the Center to share information. To be considered significant,
the safety issue of concern must meet certain criteria. In general,
CDER considers postmarket safety issues to be significant if they have
the potential to lead to any of the following actions:
     Withdrawal of an approved drug from the market.
     Withdrawal of an approved indication.
     Limitations of a use in a specific population or
subpopulation.
     Additions or modifications to the Contraindications or
Warnings and Precautions sections of the labeling, to the Medication
Guide or other required Patient Package Insert, including safety
labeling changes required under the Food and Drug Administration
Amendments Act (FDAAA).
     Establishment of or changes to the proprietary name/
container label/labeling/packaging to reduce the likelihood of
medication errors.
     Establishment or modification of a risk evaluation and
mitigation strategy (REMS).
     A requirement that a sponsor conduct a safety-related
postmarket clinical trial or observational epidemiological study.
     The conduct of a safety-related observational
epidemiological study by FDA.
    Since the DARRTS safety tracking function was introduced in 2007,
about 1,000 TSIs have been entered into the system. Although all of
these issues are considered significant, not all TSIs are equally
urgent. Furthermore, CDER does not have adequate resources to manage
all TSIs equally rapidly. In the past, prioritization of the TSIs has
been handled informally and on a case-by-case basis, without an agreed
upon framework for establishing priority.
    The Center is now seeking to establish a formal framework for
assessing the relative urgency of TSIs, so that CDER can direct
resources more effectively toward the issues that pose the greatest
potential risk for patients. This framework will classify TSIs as
``priority'' or ``standard'' for CDER review. In addition, the Center
will recognize a special ``emergency'' category for certain priority
TSIs. The use of a formal framework is intended to ensure that staff
working in different offices across CDER reaches similar conclusions
about the relative urgency of TSIs, and help them direct attention to
those that need to be addressed most expeditiously. It will also inform
CDER decisions about public drug safety communications, so that health
care practitioners and patients receive timely information about safety
risks with the greatest public health significance.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: March 6, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5777 Filed 3-8-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 95 (Tuesday, May 17, 2011)]
[Rules and Regulations]
[Pages 28312-28315]
[FR Doc No: 2011-12007]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-1015]
RIN 1625-AA00

Safety Zones; Fireworks Display Kanawha River, WV

AGENCY: Coast Guard, DHS.

ACTION: Interim final rule with request for comments.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard is establishing three permanent safety zones
in the Ohio Valley Captain of the Port Zone on specified waters of the
Kanawha River in Charleston and St. Albans, West Virginia. These safety
zones are necessary to protect persons and vessels from the potential
safety hazards associated with annual firework displays. When these
safety zones are activated, and thus subject to enforcement, this rule
would limit the movement of vessels within the established fireworks
display areas. Entry into, transit through, mooring, or anchoring
within the zones during time of enforcement is prohibited unless
authorized by the Captain of the Port, Ohio Valley or designated
representative.

DATES: This rule is effective May 17, 2011. Comments must be submitted
by June 16, 2011.

ADDRESSES: You may submit comments identified by docket number USCG-
2010-1015 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.
    Documents indicated in this preamble as being available in the
docket are part of docket USCG-2010-1015 and are available online by
going to http://www.regulations.gov, inserting USCG-2010-1015 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Petty Officer Marceli Rogoza, Marine Safety Unit
Huntington Coast Guard; telephone<PHONE_NUMBER> extension 2137, e-mail
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

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

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2010-1015), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online, or by fax, mail or hand delivery, but please use only one of
these means. We recommend that you include your name and a mailing
address, an e-mail address, or a phone number in the body of your
document so that we can contact you if we have questions regarding your
submission.
    To submit your comment online, go to http://www.regulations.gov,
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-2010-1015'' in the
``Keyword'' box. Click ``Search'' then click on the balloon shape in
the ``Actions'' column. If you submit your comments by mail or hand
delivery, submit them in an unbound format, no larger than 8\1/2\ by 11
inches, suitable for copying and electronic filing. If you submit them
by mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and may change this rule based on your comments.

Viewing Comments and Documents

    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-2010-1015'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
If you do not have access to the Internet, you may view the docket
online by visiting the Docket Management Facility in Room W12-140 on
the ground floor of the Department of Transportation West Building,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. We have an
agreement with the Department of Transportation to use the Docket
Management Facility.

Privacy Act

    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).

Public Meeting

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

II. Regulatory Information

    The Coast Guard is issuing this interim final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because standard notice procedures are
impracticable. Immediate action is necessary to ensure the safety of
vessels, spectators, participants, and others in the vicinity of the
marine event on the dates and times this rule will be in effect.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective in less than 30 days after
publication in the Federal Register because a delayed effective date
would be impracticable as immediate action is necessary to ensure the
safety of the public during the scheduled fireworks events.

Basis and Purpose

    The U.S. Coast Guard is establishing three permanent safety zones
to ensure public safety during annual fireworks displays occurring on
the specified waters of the Kanawha River, West Virginia. These safety
zones are necessary to protect the public from the hazards associated
with fireworks displays. These fireworks displays are scheduled to
occur annually during the first week of June. The Captain of the Port
Ohio Valley or designated representative will give notice of
enforcement of each safety zone by all appropriate means to provide the
widest publicity among the affected segments of the public.

Discussion of Rule

    The Captain of the Port Ohio Valley is establishing three safety
zones for the specified waters of the Kanawha River. The first, for the
West Virginia Special Olympics Fireworks Display, is located between
mile 57.9 and 58.9 in Charleston, West Virginia and is effective
annually on the first Friday in June. The second safety zone, for the
West Virginia Symphony Sunday Fireworks, is located between mile 59.5
and 60.5 in Charleston, West Virginia and is effective annually on the
first Sunday in June. The third safety zone for the St. Albans
Fireworks Display is located in St. Albans, West Virginia between mile
46.0 and 47.0 of the Kanawha River and is effective the last Saturday
in June.
    The term ``participating vessel'' includes all vessels registered
with the fireworks event officials to work in the event. With the
exception of participating vessels and those mariners operating
participating vessels, all vessels and persons are prohibited from
transiting within this safety zone unless authorized by the Captain of
the Port Ohio Valley or a designated representative. The Captain of the
Port Ohio Valley may be contacted on VHF-FM Channels 13 or 16, or by
telephone at<PHONE_NUMBER>. The Captain of the Port Ohio Valley will
inform the public through broadcast notice to mariners of the
enforcement periods for the safety zones.

Regulatory Analyses

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

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    We expect the economic impact of this rule to be so minimal that a
full Regulatory Evaluation is unnecessary. This determination is based
on the size and location of the safety zones. The basis of this finding
is that the safety zone will only be in effect for a limited time
period on one day each year and notifications to the marine community
will be made through broadcast notice to mariners.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
would not have a significant economic impact on a substantial number of
small entities. This rule will affect the following

entities, some of which may be small entities: The owners or operators
of vessels intending to transit the specified waters of the Kanawha
River during the first week in June each year. This safety zone will
not have a significant economic impact on a substantial number of small
entities because this rule will only be in effect for limited time
period on one day each year during the fireworks displays.
    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.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule 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 Petty Officer Marceli Rogoza.
The Coast Guard will not retaliate against small entities that question
or complain about this rule or any policy or action of the Coast Guard.

Collection of Information

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

Federalism

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

Unfunded Mandates Reform Act

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

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

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

Indian Tribal Governments

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

Energy Effects

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

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have 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 rule is categorically excluded,
under figure 2-1, paragraph (34)(g.), of the Instruction. This rule
involves regulations establishing safety zones. An environmental
analysis checklist and a categorical exclusion determination are
available in the docket where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50
U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.822 to read as follows:

Sec.  165.822  Safety Zone; Fireworks Display, Kanawha River, WV.

    (a) Safety Zones. The following areas are designated safety zones:
all waters between the specified mile markers on the Kanawha River,
described as follows in the Table to Sec.  165.822(a):

                                           Table to Sec.   165.822(a)
----------------------------------------------------------------------------------------------------------------
              Event name                       Event location                       Scheduled date
----------------------------------------------------------------------------------------------------------------
West Virginia Special Olympics         Between mile 57.9 and 58.9,    First Friday in June.
 Fireworks Display.                     Charlestown, WV.
West Virginia Symphony Sunday          Between mile 59.5 and 60.5,    First Sunday in June.
 Fireworks Display.                     Charlestown, WV.
St. Albans Fireworks Display.........  Between mile 46.0 and 47.0,    Last Saturday in June.
                                        St. Albans, WV.
----------------------------------------------------------------------------------------------------------------

     (b) Enforcement. The Captain of the Port Ohio Valley or designated
representative will inform the public through broadcast notice to
mariners of the enforcement periods for the safety zones.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into this zone is prohibited unless
authorized by the Captain of the Port Ohio Valley or designated
representative.
    (2) Persons or vessels requiring entry into or passage through this
zone must request permission from the Captain of the Port Ohio Valley,
or a designated representative. They may be contacted on VHF-FM
Channels 13 or 16, or by telephone at<PHONE_NUMBER>.
    (3) All persons and vessels shall comply with the instructions of
the Captain of the Port Ohio Valley and designated on-scene U.S. Coast
Guard patrol personnel.
    (4) On-scene U.S. Coast Guard patrol personnel include
commissioned, warrant, and petty officers of the U.S. Coast Guard.

    Dated: March 15, 2011.
L.W. Hewett,
Captain, U.S. Coast Guard, Captain of the Port Ohio Valley.
[FR Doc. 2011-12007 Filed 5-16-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4324-4325]
[FR Doc No: 2015-01425]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74115; File No. SR-BYX-2012-019]

Self-Regulatory Organization; BATS Y-Exchange, Inc.; Order
Granting an Extension to Limited Exemption From Rule 612(c) of
Regulation NMS in Connection With the Exchange's Retail Price
Improvement Program

January 22, 2015.
    On November 27, 2012, the Securities and Exchange Commission
(``Commission'') issued an order pursuant to its authority under Rule
612(c) of Regulation NMS (``Sub-Penny Rule) \1\ that granted the BATS
Y-Exchange, Inc. (``BYX'' or the ``Exchange'') a limited exemption from
the Sub-Penny Rule in connection with the operation of the Exchange's
Retail Price Improvement (``RPI'') Program (the ``Program''). The
limited exemption was granted concurrently with the Commission's
approval of the Exchange's proposal to adopt the Program for a one-year
pilot term.\2\ The exemption was granted coterminous with the
effectiveness of the pilot Program and has been extended once; \3\ both
the pilot Program and exemption are scheduled to expire on January 31,
2015.
---------------------------------------------------------------------------

    \1\ 17 CFR 242.612(c).
    \2\ See Securities Exchange Act Release No. 68303 (November 27,
2012), 77 FR 71652 (December 3, 2012) (``RPI Approval Order'') (SR-
BYX-2012-019).
    \3\ See Securities Exchange Act Release No. 71249 (January 7,
2014), 79 FR 2229 (January 13, 2012) (SR-BYX-2014-001) (extending
the pilot period); Securities Exchange Act Release No. 71250
(January 7, 2014), 79 FR 2234 (January 13, 2012) (Order Granting an
Extension to Limited Exemption From Rule 612(c) of Regulation NMS in
Connection With the Exchange's Retail Price Improvement Program).
---------------------------------------------------------------------------

    The Exchange now seeks to extend the exemption until January 31,
2016.\4\ The Exchange's request was made in conjunction with an
immediately effective filing that extends the operation of the Program
until January

31, 2016.\5\ In its request to extend the exemption, the Exchange notes
that the Program was implemented gradually over time. Accordingly, the
Exchange has asked for additional time to allow itself and the
Commission to analyze data concerning the Program, which the Exchange
committed to provide to the Commission.\6\ For this reason and the
reasons stated in the Order originally granting the limited exemption,
the Commission finds that extending the exemption, pursuant to its
authority under Rule 612(c) of Regulation NMS, is appropriate in the
public interest and consistent with the protection of investors.
---------------------------------------------------------------------------

    \4\ See letter from Eric Swanson, Senior Vice President and
General Counsel, BYX, to Elizabeth M. Murphy, Secretary, Commission,
dated January 16, 2015.
    \5\ See SR-BYX-2015-05.
    \6\ See RPI Approval Order, supra note 2, at 77 FR at 71657.
---------------------------------------------------------------------------

    Therefore, it is hereby ordered, that, pursuant to Rule 612(c) of
Regulation NMS, the Exchange is granted a limited exemption from Rule
612(c) of Regulation NMS that allows it to accept and rank orders
priced equal to or greater than $1.00 per share in increments of
$0.001, in connection with the operation of its RPI Program, until
January 31, 2016.
    The limited and temporary exemption extended by this Order is
subject to modification or revocation if at any time the Commission
determines that such action is necessary or appropriate in furtherance
of the purposes of the Securities Exchange Act of 1934. Responsibility
for compliance with any applicable provisions of the federal securities
laws must rest with the persons relying on the exemption that is the
subject of this Order.
    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(83).

Brent J. Fields,
Secretary.
[FR Doc. 2015-01425 Filed 1-26-15; 8:45 am]
BILLING CODE 8011-01-P


 1 STATE SMALL BUSINESS STATIONARY SOURCE TECHNICAL AND ENVIRONMENTAL COMPLIANCE ASSISTANCE PROGRAM ( SBTCP)

ANNUAL REPORTING FORM FOR THE PERIOD 1/ 1/ 01 TO 12/ 31/ 01 OMB NO.: 2060 0337 EXPIRATION DATE: x/ xx/ xx *** Completed forms are due by March 1, 2002 ***

This is the Annual Reporting Form for the State Small Business Stationary Source Technical and Environmental Compliance Assistance Programs ( SBTCPs) under the Clean Air Act ( CAA) as amended in 1990. We are collecting objective information on each SBTCP. This report is not an evaluation of your program.

INSTRUCTIONS FOR COMPLETING THIS FORM 1. Please complete the web enabled version of the Form. Do not answer questions by referring to attached documents or a previous SBTCP report.

2. You should already collect the requested information. If a question asks for data you do not have, please briefly explain why it is not available. For future reports, you may need to revise the statistics that you track.

3. Each answer block ( with the noted exceptions) must contain information to be answered complete. If part of the question does not apply, indicate " not applicable", " NA", or another appropriate answer.

4. Submit your completed form by clicking on the large " submit this form" button on the opening page. Click this button only when all answers are complete and they have been reviewed by all necessary parties. Clicking on this button will permanently lock and submit your form.

WHAT IF I HAVE QUESTIONS?

If you have any comments on how to improve this Form, please call the U. S. EPA Small Business Ombudsman ( EPA SBO), at 202 260 0490 or 800 368 5888, Monday through Friday, 8: 30 AM  5: 00 PM ( EST). After these hours, you can leave a message on the answering machine.

For any technical questions on completing, printing, or submitting your form, please contact Angel Martin Dias at 412 577 2643 or e mail martindias@ ctc. com.

WHY IS EPA REQUESTING THIS FORM?

As part of the CAA, the U. S. Congress required that each state and territory establish a Small Business Stationary Source Technical and Environmental Compliance Assistance Program ( SBTCP) to help small businesses comply with this Act. As part of its reporting requirements to Congress, EPA includes information about the SBTCP programs using information you provide on this Form. EPA has given the responsibility for this report to its SBO, who uses this Form as a standard information collection tool.

SUGGESTIONS FOR COMPLETING THIS FORM $ Gathering information for this report is definitely a team effort! Enlist the help of key contacts from the SBO, the SBAP, and the CAP, and ask them to complete applicable sections.

$ One person should take responsibility to complete and submit this Form ( most likely the SBO). 2 $ Refer to last year's Report to Congress and the information you provided on your Reporting Form last year when completing this year's Reporting Form.

PROGRAM INFORMATION State, territory, or local agency for which this report is being submitted.

REPORTING FORM CONTACT Name Title Agency/ Organization Address City, State, Zip Telephone Number Facsimile Number E mail BUDGET Record the combined budget for your SBO, SBAP, and CAP for calendar year 2001. ( If your budget is by fiscal year, please indicate the FY budget that is in effect as of 12/ 31/ 01.)

2001 Budget STAFFING How many people, measured as full time equivalents ( FTEs), support the SBO and SBAP?

Total FTEs What is the status of your CAP as of the end of 2001?

Status Check if applicable Complete ( at least 7 members)? 3 Active ( holding regular meetings, conducting activities, etc.)?

OUTREACH AND TECHNICAL ASSISTANCE Does your program offer air only or multimedia assistance?

Air only Multimedia Please indicate the requested data for each type of activity during 2001.

ACTIVITY TOTALS Hotline/ e mail # calls/ e mails =

Onsite visit # visits =

Seminars/ workshops # events = # participants =

Publications/ mailings # documents = # copies distributed =

Home page # hits =

Video & Teleconferences # events = # attendees =

Permit applications # permits =

Other # =

TOTAL ASSISTS Please include any information about your program that you would like to highlight, such as significant accomplishments, awards, move to multimedia, etc. Case studies are especially appreciated!


[Federal Register: September 23, 2010 (Volume 75, Number 184)]
[Notices]
[Page 58004-58006]
[DOCID:fr23se10-111]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62927; File No. SR-FINRA-2010-046]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Proposed Rule Change Relating to
Exemptions from the Trading Activity Fee

September 17, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 7, 2010, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to [sic] amend Section 1(b) of Schedule A to the
FINRA By-Laws to remove the exemption from the trading activity fee
(``TAF'') for transactions in exchange-listed options effected by a
member when FINRA is not the designated options examining authority
(``DOEA'') for that member.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The TAF is one of three member regulatory fees FINRA uses to fund
its member regulation activities, which include examinations, financial
monitoring, and FINRA's policymaking, rulemaking, and enforcement
activities.\3\ FINRA initially adopted the TAF in 2002 as a replacement
for an earlier regulatory fee based on trades reported to Nasdaq's
Automated Confirmation Transaction system then in place.\4\ Because the
TAF funds FINRA's member regulation functions, it is intended to apply
to transactions in a way that corresponds with FINRA's regulatory
responsibilities.\5\ In general, the TAF is assessed for the sale of
all exchange registered securities wherever executed (except debt
securities that are not TRACE-eligible), over-the-counter equity
securities, security futures, TRACE-Eligible Securities (provided that
the transaction is a Reportable TRACE Transaction), and all municipal
securities subject to the reporting requirements of the Municipal
Securities Rulemaking Board.\6\ The TAF rules also include numerous
exemptions for certain types of transactions.\7\ The proposed rule
change would eliminate the exemption from the TAF for transactions in
exchange-listed options when FINRA is not the DOEA for that member.\8\
---------------------------------------------------------------------------

    \3\ See FINRA By-Laws, Schedule A, Sec.  1(b). In addition to
the TAF, the other member regulatory fees are the Gross Income
Assessment and the Personnel Assessment. See id. Sec. Sec.  1(c),
(d).
    \4\ See Securities Exchange Act Release No. 46416 (August 23,
2002), 67 FR 55901 (August 30, 2002) (Notice of Filing and Immediate
Effectiveness of Proposed Rule Change and Amendment No. 1 by the
National Association of Securities Dealers, Inc. to Eliminate the
Regulatory Fee and Institute a New Transaction-Based Trading
Activity Fee); see also NASD Notice to Members 02-63 (September
2002); NASD Notice to Members 02-41 (July 2002). The TAF was
originally approved on a pilot basis; the SEC approved the TAF on a
permanent basis in 2003. See Securities Exchange Act Release No.
47946 (May 30, 2003), 68 FR 34021 (June 6, 2003); see also NASD
Notice to Members 03-30 (June 2003).
    \5\ See Securities Exchange Act Release No. 50485 (October 1,
2004), 69 FR 60445 (October 8, 2004).
    \6\ See FINRA By-Laws, Schedule A, Sec.  1(b)(1).
    \7\ See FINRA By-Laws, Schedule A, Sec.  1(b)(2).
    \8\ See FINRA By-Laws, Schedule A, Sec.  1(b)(2)(K).
---------------------------------------------------------------------------

    In 2003, FINRA exempted from the TAF ``[t]ransactions in exchange
listed options effected by a member when FINRA is not the designated
options examining authority for that member.'' \9\ The exemption was
added to reflect the

fact that FINRA's regulatory responsibilities with respect to such
activity were alleviated somewhat by its participation in a plan filed
with the SEC under Rule 17d-2 of the Act \10\ (``17d-2 Agreement'') in
which regulatory responsibilities for certain FINRA members that
conducted a public options business were assumed by other self
regulatory organizations (``SROs'') that would act as the member's
DOEA.\11\ At that time, of the approximately 450 member firms covered
by the 17d-2 Agreement, FINRA assumed regulatory responsibilities
(i.e., was the DOEA) for about 300 firms, and the remaining firms were
divided among six other SROs. Thus, in view of the fact that another
SRO performed certain regulatory responsibilities with respect to the
options activities of these members, FINRA decided to exempt
transactions in exchange listed options by such firms from the TAF.\12\
---------------------------------------------------------------------------

    \9\ FINRA By-Laws, Schedule A, Sec.  1(b)(2)(K). See Securities
Exchange Act Release No. 47946 (May 30, 2003), 68 FR 34021 (June 6,
2003).
    \10\ 17 CFR 240.17d-2.
    \11\ See Securities Exchange Act Release No. 46800 (November 8,
2002), 67 FR 69774 (November 19, 2002).
    \12\ Transactions in over-the-counter (``conventional'') options
are exempted from the TAF with respect to all FINRA members. See
FINRA By-Laws, Schedule A, Sec.  1(b)(2)(H).
---------------------------------------------------------------------------

    The exemption was also based on the fact that certain other SROs
were assessing or preparing to assess specific regulatory fees for
acting as DOEA.\13\ To the extent that other SROs assessed specific
fees on firms to fund the SRO's DOEA responsibilities with respect to
those firms, FINRA's TAF on options transactions appeared redundant.
---------------------------------------------------------------------------

    \13\ See, e.g., Securities Exchange Act Release No. 47577 (March
26, 2003), 68 FR 16109 (April 2, 2003) (SR-PCX-2003-03) (PCX rule
filing establishing a DOEA fee).
---------------------------------------------------------------------------

    Subsequent amendments to the 17d-2 Agreement have consolidated
within FINRA sole regulatory responsibility for the public options
activities of all of its members.\14\ Consequently, FINRA assumes all
regulatory responsibility for FINRA members under the 17d-2
Agreement.\15\ Based on the foregoing, FINRA is proposing to delete the
exemption from the TAF.\16\
---------------------------------------------------------------------------

    \14\ See Securities Exchange Act Release No. 57987 (June 18,
2008), 73 FR 36156 (June 25, 2008) (Notice of Filing and Order
Approving and Declaring Effective an Amendment to the Plan for the
Allocation of Regulatory Responsibilities Among the American Stock
Exchange LLC, the Boston Stock Exchange, Inc., the Chicago Board
Options Exchange, Inc., the International Securities Exchange, LLC,
Financial Industry Regulatory Authority, Inc., The New York Stock
Exchange, LLC, the NYSE Arca, Inc., The NASDAQ Stock Market LLC, and
the Philadelphia Stock Exchange, Inc.).
    \15\ Following the consolidation of NASD and NYSE member
regulation operations in 2007, FINRA announced that it serves as the
DOEA for all FINRA member firms. See Regulatory Notice 08-37 (July
2008). FINRA had previously published a list of firms that had a
DOEA other than FINRA and, consequently, were exempt from the TAF
for transactions in exchange listed options. See NASD Notice to
Members 05-03 (January 2005).
    \16\ At the time FINRA (then NASD) proposed the exemption in
Amendment No. 4 to SR-NASD-2002-148, it noted that ``NASD does not
believe it is precluded from seeking further amendments to the TAF
with respect to the reduction or elimination of the proposed
exemption * * * in the event of a change of factors surrounding its
sales practice and other regulatory responsibilities.''
---------------------------------------------------------------------------

    Deleting this exemption also will remove any ambiguities over
whether FINRA should collect the TAF on sole-FINRA members or with
respect to FINRA members that conduct only a proprietary options
business. The existing language exempting transactions in exchange
listed options from the TAF when FINRA is not the DOEA for the member
does not properly align with those situations where FINRA has
regulatory responsibility over the member firm. First, the DOEA
designation is established only under the 17d-2 Agreement, which by its
own terms applies only with respect to firms that are members of more
than one SRO. Thus, while FINRA has regulatory responsibility for the
options business of its sole members, FINRA is not technically the DOEA
for such firms. Second, the 17d-2 Agreement addresses only a firm's
public options business. As such, a firm that conducts only a
proprietary options business, irrespective of whether such firm is a
member of FINRA and another SRO, would not be covered by the 17d-2
Agreement, and FINRA would not technically be the DOEA. Although
FINRA's regulatory responsibilities are more limited for a firm that
does not conduct a public options business, FINRA still retains
regulatory responsibilities over the firm's options activities.
    The effective date of the proposed rule change will be the first
day of the month following Commission approval. FINRA will announce the
effective date of the proposed rule change in a Regulatory Notice to be
published no later than 30 days following Commission approval.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(5) of the Act,\17\ which requires, among
other things, that FINRA rules provide for the equitable allocation of
reasonable dues, fees and other charges among members and issuers and
other persons using any facility or system that FINRA operates or
controls. FINRA believes that because it maintains regulatory
responsibility over its members' transactions in exchange listed
options, the exemption from the TAF for transactions in exchange listed
options when FINRA is not the DOEA for that member is no longer
necessary. Eliminating the exemption will also ensure that the TAF more
accurately reflects the current allocation of regulatory
responsibilities to FINRA of its members' transactions in exchange
listed options.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78o-3(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2010-046 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FINRA-2010-046. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for website
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of FINRA.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make publicly
available. All submissions should refer to File Number SR-FINRA-2010-
046 and should be submitted on or before October 14, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-23773 Filed 9-22-10; 8:45 am]
BILLING CODE 8010-01-P