U. S. ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM PC Code No. 120051 DP Barcode D285445 April 22, 2003 SUBJECT: IR 4 Tolerance Petition for Dimethenamide P1 ( Outlook and Frontier ® 6.0) Use on: Onion ( Dry Bulb), Garlic, Shallots ( Dry Bulb), Tuberous and Corm Vegetables, Sugar Beet, Garden Beet and Horseradish.

TO: Robert Forrest, Product Manager 05 Shaja Brothers, PM Team Reviewer Registration Division FROM: Lucy Shanaman, Chemist; ERB III, EFED ( 7507C) James Wolf, Soil Scientist; ERB III, EFED ( 7507C); scenario development PEER REVIEW: Kevin J. Costello, Geologist, RAPL; ERB III, EFED ( 7507C)

THROUGH: Ben Smith, Chief; ERB III, EFED ( 7507C)

1 The Data Package Record (" Bean Sheet") spells the product name as it appears throughout this document. However, the actual petition document submitted by the IR 4, the EFED Section 3 document produced for the initial registration of the resolved isomer, and the British Compendium of Pesticide Common Names web site all lists the spelling of the common chemical name associated with the stated Chemical Abstract Registration Number, as " Dimethenamid P" ( http:// www. hclrss. demon. co. uk/ index. html). REFS lists both as correct spellings for the common name. 2 The Environmental Fate and Effects Division ( EFED) has reviewed the IR 4 tolerance petition ( DP Barcode D285445) for use of the herbicide, Dimethenamide P1 ( Outlook and Frontier ® 6.0), on onion ( dry bulb), garlic, shallots ( dry bulb), tuberous and corm vegetables, sugar beet, garden beet and horseradish. Dimethenamide P ( PC120051) is the 94% resolved s isomer of the racemic r/ smixture registered under product code 129051. The maximum proposed seasonal application rate is 1.5 lb a. i./ acre ( maximum of 1.5 lb a. i./ acre for individual applications), which can be divided into 2 applications per year, made at 14 day intervals. Drinking water concentrations have been predicted using a standard Georgia onion scenario as a surrogate for use on all proposed crops at the maximum early postemergence application rate for onions, and using acceptable environmental fate and transport data submitted to the Agency. Tier II surface water concentrations are predicted by the PRZM/ EXAMS model at 49 µ g/ L for acute exposure, 7.9 µ g/ L for non cancer chronic exposure, and 5.1 µ g/ L for overall chronic exposure. Ground water concentrations of 0.42 µ g/ L were predicted by the Tier I model, SCIGROW. ( Table 2) This assessment is for parent compound only. After HED has held a MARC meeting, EFED can revise this drinking water assessment to include any degradates of concern.

Environmental Fate Assessment Dimethenamide P [( 2 chloro N( 1 methyl 2 methoxy) ethyl) N( 2,4 dimethyl thien 3 yl) acetamide; see structure below] is mobile ( Kd = 1.4 to 3.0) and moderately persistent in the environment. Dimethenamide P is moderately susceptible to aerobic biodegradation ( mean half life = 37 days at the 90% confidence interval), and stable to hydrolysis. Photodegradation in aqueous media is expected to be a minor route of dissipation. Dimethenamide P is likely to leach to ground water, and has the potential to contaminate drinking water.

Dimethenamide P ( CASRN 163515 14 8)

Drinking Water Assessment Models Used 3 The Tier II estimated concentrations for drinking water derived from surface water sources were modeled using: ( 1) PRZM version 3.12 ( documented; Carsel et al., 1997), model dated May 7, 1998 to simulate the transport of the pesticide off the field, and ( 2) EXAMS 2.97.5 ( documented; Burns, 1997), model dated June 13, 1997, to simulate the fate of the chemicals in the water body. Both models were launched from a shell ( pe3) recently developed within EFED, and adopted for use on February 27, 2002. Reported values were adjusted for percent cropped area, as per EFED policy.

SCIGROW ( version 2.2, November 1, 2001) provided the Tier 1, groundwater screening exposure value to be used in determining the potential risk to human health from drinking water contaminated with the pesticide. In most cases, a large majority of the use area will have groundwater that is less vulnerable to contamination than the areas used to drive the SCIGROW estimate.

Surface Water Scenarios Two standard scenarios were chosen to model estimated environmental concentrations in surface water resulting from the proposed new uses of dimethenamide P, based on particularly vulnerable crop sites and the higher application rates proposed for use on onion crops. California and Georgia onion index reservoir scenarios were chosen as surrogates for estimating environmental concentrations in sites more vulnerable to the offsite movement of pesticide than most sites planted with the respective new crops proposed for this registration. Background Information for the PRZM/ EXAMS Index Reservoir Standard Scenarios appear in Appendix B.

Modeling Inputs and Results Table 1 summarizes the general input values used in the model runs for PRZM/ EXAMS and SCIGROW, respectively for dimethenamide P, applied annually by aerial spray to onions at a rate of 1.5 pounds per acre. Surface water and ground water modeling results appear in Table 2. PRZM/ EXAMS and SCIGROW output files have been appended to this document. ( Appendix A)

The PRZM/ EXAMS input parameters for metabolism half lives were selected in accordance with US EPA OPP EFED water model parameter selection guidelines, Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides, Version II, February 28, 20022. Dimethenamide P is the 94% resolved s isomer of the racemic r/ s mixture ( registered under product code 129051). In most cases ( Table 1), data for both the racemic mixture and the resolved isomer were used to generate input values. Submitted aerobic soil metabolism half lives were not significantly different, and therefore not distinguishable, between the resolved and the mixed isomers. Both data sets were used to generate a more statistically powerful aerobic soil input parameter value.

2 http:// www. epa. gov/ oppefed1/ models/ water/ index. htm 4 While no anaerobic metabolic data were available for s dimethenamid, anaerobic data for the r/ s racemic mixture suggests the need for a more conservative input value than that produced by applying the standard EFED estimating approach for generating anaerobic metabolism half lives by multiplication of the aerobic soil metabolism data for the resolved s isomer. The soil to water partitioning coefficient values, Kd and Koc, selected as input parameter values under EFED guidance policy would remain unchanged regardless of using either combined s and r/ s data, or data only for the resolved s isomer. Application methods and rates for the modeled onion crops were obtained from submitted labels.

Table 1: Drinking Water Model Input Parameters for Dimethenamide P Input Value Study Type s Dimethenamid MRID # r/ s Dimethenamid MRID # SCIGROW PRZM / EXAMS Hydrolysis stable 44332258 stable 41596531  stable Aqueous Photolysis 25.7 days 44332259 16.4 days 42266207  26 days ( dark corrected)

31 days 44332261 30 days 44332261 Aerobic Soil Metabolism 38 days 41596532 31 days ( average) 37 days ( mean t1/ 2 + ( t90 x s)/ n1/ 2)

Anaerobic Soil Metabolism 54 days 41706801 162 days ( one value, 54 x 3)

Anaerobic Aquatic Metabolism 36 days 42367201 108 days ( one value, 36 x 3)

Kd = 3.5, 0.7, 2.0 Koc = 121, 233, 118 42034806 Mobility ( lowest non sand value) Kd = 2.1, 2.5, 3.0, 1.4, 2.0 Koc = 212, 105, 247, 396, 129 44332263 Koc = 390, 188, 417 41596533 105 mL/ g ( lowest nonsand Koc) 1.4 ( lowest non sand Kd)

Maximum Application Rate for use on: onion, garlic, shallot 1.5 lb. a. i./ acre Application Efficiency Fraction ariel application  0.95 5 Spray Drift Fraction ariel application  0.16 CA onions Dec. 15th Application Date for early postemergence application

GA onions Sep. 20th Incorporation Depth wetted in  CAM = 1 Aqueous Solubility ( 25 ° C) 41596507  1174 mg/ L As previously noted, PRZM/ EXAMS drinking water concentrations have been predicted for dimethenamide P, a 94% resolved s isomer, used at the maximum proposed early postemergence application rate of 1.5 lb a. i./ acre for dry bulb onions grown in Georgia and California. Predicted concentrations in drinking water derived from surface water sources resulting from the use of dimethenamide P on California onion crops were predicted to be 40 µ g/ L for acute exposure, 10   g/ L for non cancer chronic exposure, and 5.0   g/ L for overall chronic exposure. Predicted concentrations in drinking water derived from surface water sources resulting from the use of dimethenamide P on Georgia onion crops were predicted to be 49 µ g/ L for acute exposure, 7.9   g/ L for non cancer chronic exposure, and 5.1   g/ L for overall chronic exposure. Reported values have been adjusted for percent crop area by multiplying by the default factor of 0.87, as dictated by EFED policy. ( Appendix A) Ground water concentrations of 0.42 µ g/ L were predicted by the Tier I model, SCIGROW. ( Table 2) This assessment is for parent compound only. After HED has held a MARC meeting, EFED can revise this drinking water assessment to include any degradates of concern.

Table 2. Estimated Drinking Water Concentrations for Dimethenamide P Acute Exposure ( one in 10 year peak value) Non Cancer Chronic Exposure ( one in 10 year annual mean value) 36 Year Average ( surface water is overall mean annual value for 36 years)

Groundwater1   0.421502 µ g/ L Georgia California Georgia California Georgia California Surface Water2 49 µ g/ L * 40 µ g/ L * 7.9 µ g/ L * 10 µ g/ L * 5.1 µ g/ L * 5.0 µ g/ L *

1 Appendix A contains output for SCIGROW model used to estimate groundwater concentration 2 Appendix A contains output for PRZM/ EXAMS model using a standard Georgia onion and a California onion scenario for an index reservoir scenario used to estimate upper tenth percentile surface ( drinking) water concentration.

* Reported values adjusted for percent crop area by multiplying by a factor of 0.86, as dictated by EFED policy. 6 Files used in generating and capturing the modeling values above can be located at: F:\ User\ LShanama\ 110051dimethenamide\ ScigrowOnions. txt F:\ User\ LShanama\ 110051dimethenamide\ w03822. dvf F:\ User\ LShanama\ 110051dimethenamide\ w23155. dvf F:\ User\ LShanama\ 110051dimethenamide\ CAonions. pzr F:\ User\ LShanama\ 110051dimethenamide\ GAonions. pzr F:\ User\ LShanama\ 110051dimethenamide\ dmaCAon. out F:\ User\ LShanama\ 110051dimethenamide\ dmaGAon. out F:\ User\ LShanama\ 110051dimethenamide\ reportdmaCAon. xms F:\ User\ LShanama\ 110051dimethenamide\ reportdmaGAon. xms 7 APPENDIX A PRZM/ EXAMS ( Surface Drinking Water Concentrations using Index Reservoir Scenario)

California Onions stored as dimethenamide P. out Chemical: dimethenamide P PRZM environment: CAonionC. txt modified Monday, 23 December 2002 at 06: 48: 48 EXAMS environment: ir298. exv modified Thuday, 29 August 2002 at 15: 34: 12 Metfile: w23155. dvf modified Wedday, 3 July 2002 at 09: 04: 20 Water segment concentrations ( ppb)

Year Peak 96hr 21Day 60Day 90Day Yearly 1961 9.794 9.761 7.805 2.732 1.821 0.4491 1962 12.73 12.69 10.72 9.915 9.669 6.79 1963 15.29 15.25 15.03 14.58 14.12 9.783 1964 40.63 40.53 40.03 38.77 37.66 23.83 1965 40.07 33.75 22.6 21.84 21.79 14.89 1966 40 39.91 39.43 38.62 37.75 24.32 1967 21.97 21.91 21.59 20.91 20.96 14.68 1968 27.01 26.95 26.62 25.75 24.98 16.23 1969 16.66 16.63 16.46 16.06 15.67 10.35 1970 14.42 14.38 13.68 13.55 13.38 9.096 1971 19.87 19.82 18.75 18.11 17.55 11.78 1972 24.61 24.56 24.22 23.4 22.69 15.07 1973 19.2 19.16 18.94 18.35 17.87 11.89 1974 15.62 15.58 15.37 14.81 14.66 10 1975 35.45 35.37 34.94 33.86 32.86 20.79 1976 38.08 38 37.54 36.33 35.22 22.36 1977 31.63 31.55 28.32 27.3 26.54 18.15 1978 31.41 31.35 30.99 30.26 29.56 19.11 1979 19.87 19.83 19.68 19.18 18.71 12.35 1980 17.47 17.44 17.26 16.81 16.36 10.86 1981 26.57 26.52 26.23 25.41 24.6 15.77 1982 16.58 16.55 16.37 15.94 15.55 10.28 1983 26.48 26.41 16.85 16.28 15.81 10.86 1984 32.2 32.13 31.73 30.69 29.8 19.79 1985 24.87 24.82 24.57 23.91 23.64 15.7 1986 20.84 20.79 16.23 15.8 15.42 10.41 1987 38.14 38.05 37.6 36.55 35.58 22.78 1988 24.53 24.48 24.14 23.33 22.58 15.06 1989 25.41 25.36 25.06 24.32 23.64 15.37 1990 16.18 16.15 15.97 15.55 15.39 10.35 Sorted results 8 Prob. Peak 96hr 21Day 60Day 90Day Yearly 0.032258064516129 40.63 40.53 40.03 38.77 37.75 24.32 0.0645161290322581 40.07 39.91 39.43 38.62 37.66 23.83 0.0967741935483871 40 38.05 37.6 36.55 35.58 22.78 0.129032258064516 38.14 38 37.54 36.33 35.22 22.36 0.161290322580645 38.08 35.37 34.94 33.86 32.86 20.79 0.193548387096774 35.45 33.75 31.73 30.69 29.8 19.79 0.225806451612903 32.2 32.13 30.99 30.26 29.56 19.11 0.258064516129032 31.63 31.55 28.32 27.3 26.54 18.15 0.290322580645161 31.41 31.35 26.62 25.75 24.98 16.23 0.32258064516129 27.01 26.95 26.23 25.41 24.6 15.77 0.354838709677419 26.57 26.52 25.06 24.32 23.64 15.7 0.387096774193548 26.48 26.41 24.57 23.91 23.64 15.37 0.419354838709677 25.41 25.36 24.22 23.4 22.69 15.07 0.451612903225806 24.87 24.82 24.14 23.33 22.58 15.06 0.483870967741936 24.61 24.56 22.6 21.84 21.79 14.89 0.516129032258065 24.53 24.48 21.59 20.91 20.96 14.68 0.548387096774194 21.97 21.91 19.68 19.18 18.71 12.35 0.580645161290323 20.84 20.79 18.94 18.35 17.87 11.89 0.612903225806452 19.87 19.83 18.75 18.11 17.55 11.78 0.645161290322581 19.87 19.82 17.26 16.81 16.36 10.86 0.67741935483871 19.2 19.16 16.85 16.28 15.81 10.86 0.709677419354839 17.47 17.44 16.46 16.06 15.67 10.41 0.741935483870968 16.66 16.63 16.37 15.94 15.55 10.35 0.774193548387097 16.58 16.55 16.23 15.8 15.42 10.35 0.806451612903226 16.18 16.15 15.97 15.55 15.39 10.28 0.838709677419355 15.62 15.58 15.37 14.81 14.66 10 0.870967741935484 15.29 15.25 15.03 14.58 14.12 9.783 0.903225806451613 14.42 14.38 13.68 13.55 13.38 9.096 0.935483870967742 12.73 12.69 10.72 9.915 9.669 6.79 0.967741935483871 9.794 9.761 7.805 2.732 1.821 0.4491 0.1 39.814* 38.045 37.594 36.528 35.544* 22.738* Average of yearly averages: 14.3049366666667*

Inputs generated by pe3. pl 1.2  15 October 2002 * Indicates upper tenth percentile drinking water assessment endpoints BEFORE correction for percent cropped area, as pre EFED policy. 9 PRZM/ EXAMS ( Surface Drinking Water Concentrations using Index Reservoir Scenario)

Georgia Onions stored as dmaGAon. out Chemical: dimethenamide P PRZM environment: GAOnionsC. txt modified Thuday, 30 January 2003 at 08: 26: 54 EXAMS environment: ir298. exv modified Thuday, 29 August 2002 at 15: 34: 12 Metfile: w03822. dvf modified Wedday, 3 July 2002 at 09: 04: 32 Water segment concentrations ( ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly 1961 18.63 18.16 15.97 14.12 12.22 3.235 1962 29.09 28.28 24.49 19 15.99 5.22 1963 53.98 52.52 46.95 36.43 30.25 9.03 1964 32.51 31.73 27.78 21.25 17.87 7.105 1965 26.56 25.88 23.23 18.05 15.09 5.384 1966 12.51 12.2 10.62 9.067 8.066 3.253 1967 18.12 17.62 15.52 11.92 10.07 3.358 1968 28.28 27.56 24.38 18.52 15.5 4.831 1969 28.02 27.31 23.73 19.4 16.53 5.65 1970 40.4 39.28 34.08 25.75 21.3 7.05 1971 21.12 20.58 18.52 14.32 12.27 4.89 1972 16.65 16.23 14.18 12.03 10.63 3.811 1973 18.6 18.09 16.11 12.98 11.18 3.877 1974 16.5 16.09 14.08 11.2 9.855 3.507 1975 50.52 49.12 42.92 33.17 27.49 8.026 1976 13.87 13.49 11.95 9.855 8.306 4.128 1977 12.14 11.82 10.38 9.014 7.725 2.651 1978 9.765 9.493 8.552 7.299 6.349 2.284 1979 34.39 33.48 29.17 22.4 18.64 5.42 1980 17.7 17.24 15.36 12.36 10.61 4.179 1981 29.74 28.93 25.3 19.09 15.93 5.032 1982 26.9 26.15 22.5 16.84 13.89 4.855 1983 24.98 24.35 22.18 18.07 15.13 4.915 1984 57.53 56.04 49.62 37.77 31.25 9.17 1985 13.32 13.04 11.58 8.984 7.509 4.135 1986 24.41 23.8 20.9 15.85 13.43 4.061 1987 18.37 17.91 15.72 12.11 10.67 4.017 1988 15.81 15.41 13.82 11.56 9.904 3.54 1989 154 150 131 98.27 81.01 21.89 1990 111 110 96.16 72.85 60.41 20.8 10 Sorted results Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly 0.032258064516129 154 150 131 98.27 81.01 21.89 0.0645161290322581 111 110 96.16 72.85 60.41 20.8 0.0967741935483871 57.53 56.04 49.62 37.77 31.25 9.17 0.129032258064516 53.98 52.52 46.95 36.43 30.25 9.03 0.161290322580645 50.52 49.12 42.92 33.17 27.49 8.026 0.193548387096774 40.4 39.28 34.08 25.75 21.3 7.105 0.225806451612903 34.39 33.48 29.17 22.4 18.64 7.05 0.258064516129032 32.51 31.73 27.78 21.25 17.87 5.65 0.290322580645161 29.74 28.93 25.3 19.4 16.53 5.42 0.32258064516129 29.09 28.28 24.49 19.09 15.99 5.384 0.354838709677419 28.28 27.56 24.38 19 15.93 5.22 0.387096774193548 28.02 27.31 23.73 18.52 15.5 5.032 0.419354838709677 26.9 26.15 23.23 18.07 15.13 4.915 0.451612903225806 26.56 25.88 22.5 18.05 15.09 4.89 0.483870967741936 24.98 24.35 22.18 16.84 13.89 4.855 0.516129032258065 24.41 23.8 20.9 15.85 13.43 4.831 0.548387096774194 21.12 20.58 18.52 14.32 12.27 4.179 0.580645161290323 18.63 18.16 16.11 14.12 12.22 4.135 0.612903225806452 18.6 18.09 15.97 12.98 11.18 4.128 0.645161290322581 18.37 17.91 15.72 12.36 10.67 4.061 0.67741935483871 18.12 17.62 15.52 12.11 10.63 4.017 0.709677419354839 17.7 17.24 15.36 12.03 10.61 3.877 0.741935483870968 16.65 16.23 14.18 11.92 10.07 3.811 0.774193548387097 16.5 16.09 14.08 11.56 9.904 3.54 0.806451612903226 15.81 15.41 13.82 11.2 9.855 3.507 0.838709677419355 13.87 13.49 11.95 9.855 8.306 3.358 0.870967741935484 13.32 13.04 11.58 9.067 8.066 3.253 0.903225806451613 12.51 12.2 10.62 9.014 7.725 3.235 0.935483870967742 12.14 11.82 10.38 8.984 7.509 2.651 0.967741935483871 9.765 9.493 8.552 7.299 6.349 2.284 0.1 57.175* 55.688 49.353 37.636 31.15 9.156* Average of yearly averages: 5.9768*

Inputs generaged by pe3. pl 1.2  15 October 2002 * Indicates upper tenth percentile drinking water assessment endpoints BEFORE correction for percent cropped area, as pre EFED policy. 11 SCIGROW ( Groundwater Concentrations)

SCIGROW VERSION 2.2: NOVEMBER 1, 2001 RUN No. 1 FOR dimethenamide P ** INPUT VALUES **  APP RATE APPS/ TOTAL/ SOIL AEROBIC SOIL METAB ( LBS/ AC) YEAR SEASON KOC HALFLIFE ( DAYS)  1.500 1 1.500 105.0 31.00 GROUND WATER SCREENING CONCENTRATION ( IN UG/ L  PPB)  .421502  12 APPENDIX B PRZM/ EXAMS Index Reservoir Standard Scenario Background Information The major onion growing states are AZ, CA, GA, and TX. California is first in production all types of onions ( spring, summer non storage, summer storage) ( NASS, USDA Vegetables 2001 Summary). Fresh market bulb onions are produced throughout California. The main production areas are low desert ( Imperial and Riverside Counties), the San Joaquin Valley ( Kern, Fresno, and San Joaquin Counties), the southern and central coast ( San Benito, Ventura, Santa Clara, and Monterey Counties), the high desert ( eastern Los Angeles County), and the northern mountain valleys ( Shasta, Lassen, Siskiyou and Modoc Counties). ( R. E. Voss and K. S. Mayberry. Fresh Market Bulb Onion Production in California. Univ. of California, Vegetable Research and Information Center, Publication No. 7242).

Bulb onions are planted from September through May. Harvest begins in April and May and is completed in September. RUSLE has planting on 1/ 1 and harvest 6/ 15. ( PIC has plant = 12/ 1, emergence 12/ 11, maturity 5/ 7, and harvest 6/ 1). PIC values were adjusted based upon RUSLE plant and harvest dates. Onions are most commonly grown in multiple rows on raised beds 102  107 cm wide ( other bed widths are narrower 91 cm or wider 152 203 cm). Distribution of rows depends upon irrigation method and planter. With sprinkler or drip irrigation rows are spaced equidistance across a bend at about 10 cm intervals. ( Voss and Mayberry).

RUSLE file is C21ONONC. txt. This is a Sacramento, CA onion,

The amount and frequency of irrigation depend upon method, soil type and conditions, and temperature. For optimal plant growth, irrigate when 25 percent of the available moisture in the top 61 cm of soil is depleted. An onion crop typically uses 61 to 76 cm ( mid value 68.5cm) of water. Parameters for irrigation ( growing season only) were set at 3, 0.10, 0.12, and 0.2 ( card no. 27). The time series PRZM output variable INFL for layer 1 is the daily infiltration ( precipitation and irrigation for Jan through June) into the soil surface ranged from 48.4 to 79.9 cm with an average of 70.2 cm ( comparable to 68.5 cm).

Onions will grow on a wide range of soil types: sand, loam, clay, and organic/ peat. Series in the scenario is the Ciervo clay ( Fine, smectitic, thermic Vertic Haplocambids). The soil ( http:// ortho. ftw. nrcs. usda. gov/ osd/ dat/ C/ CIERVO. html) is used mainly for irrigated cropland ( cotton, alfalfa, sugar beets, wheat, onions, and tomatoes. The soils are of a large extent in MLRA 17. The weather station is located at Bakersfield, California, meteorological file W23155. txt ( 1961 through 1990). 13 PRZM/ EXAMS CALIFORNIA ONION Scenario Background Information The field used to represent onion production in California is located in Kern County in the San Joaquin Valley, although onion production areas are quite extensive ( San Joaquin, Coastal Intermediate Region, Imperial Valley, southern and central coastal regions, the high desert areas of Los Angeles County and the northern mountain valleys). According to the 1997 Census of Agriculture, California is the major producer of onions for the market. Bulb onions are planted from September through May and harvesting begins in April or May and completed by September. Onions are cools season, biennial plants that are commercially grown as an annual. Most onions are direct seeded, but transplants are used in some fall planted fields for an earlier harvest of short day and intermediate day varieties and to achieve uniform , jumbo sized bulbs. Seeds are planted uniformly at 2 to 3 inches between plants in a row. Onions are most commonly grown in multiple rows on raised beds 40 to 42 inches wide, but some production areas use 36 inch wide beds or beds of 60 to 80 inches. Distribution of rows across beds varies depending on irrigation method and planter. With drip and sprinkler irrigation ( most common types), rows are spaced equidistant across the bed at approximately 4 inch intervals. When furrow irrigation is used, the center of the bed is left vacant for salt accumulation with 2 or 3 rows planted on either side. Plant canopy can approach 100 percent in some narrow row fields grown under drip irrigation. Irrigation is required to avoid seed or plant dry out. Generally 24 to 36 inches of irrigated water per year is sufficient. Onions can grow on a wide range of soils. The soil selected to represent the field is Ciervo clay. Ciervo clay, is a fine, semetic, thermic Vertic Haplocambids. These soils are often used for onion and other truck crop production under irrigation. Ciervo clay is a very deep, moderately well drained, medium to high runoff soil on fan skirts that formed in alluvium mainly from sedimentary rocks at elevation of 170 to 735 feet above mean sea level. The Ciervo clay has very slow permeability. Slopes range from 0 to 2 percent. The soil is of large extent in MLRA 17. Ciervo clay is a Hydrologic Group D soil.

Table 1. PRZM 3.12 Climate and Time Parameters for Kern County, California  Onions Parameter Value Source Starting Date January 1, 1961 Meteorological File  Southern: Bakersfield, CA ( W23155)

Ending Date December 31, 1990 Meteorological File  Southern: Bakersfield, CA ( W23155)

Pan Evaporation Factor ( PFAC) 0.7 PRZM Manual Figure 5.1 ( EPA, 1998)

Snowmelt Factor ( SFAC) 0.55 cm C 1 PRZM Manual Table 5.1 ( EPA, 1998)

Minimum Depth of Evaporation ( ANETD) 17.0 cm PRZM Manual Figure 5.2 ( EPA, 1998) 14 Table 2. PRZM 3.12 Erosion and Landscape Parameters for Kern County, California  Onions Parameter Value Source Method to Calculate Erosion ( ERFLAG) 4 ( MUSS) PRZM Manual ( EPA, 1998)

USLE K Factor ( USLEK) 0.21 tons EI 1* PRZM Input Collator ( Burns, 1992) and FARM Manual ( EPA, 1985)

USLE LS Factor ( USLELS) 0.303 Haan and Barfield, 1979 USLE P Factor ( USLEP) 0.5 PRZM Manual ( EPA, 1998)

Field Area ( AFIELD) 172 ha Area of Shipman Reservoir watershed ( EPA, 1999)

NRCS Hyetograph ( IREG) 1 PRZM Manual Figure 5.12 ( EPA, 1998)

Slope ( SLP) 1% Mid point of the Soil Series, Ciervo Hydraulic Length ( HL) 600 m Shipman Reservoir ( EPA, 1999)

Irrigation Flag ( IRFLAG) 2 ( cropping period only) Voss, R. E. Fresh Market Bulb Onion Production in California. U. fo CA Publication 7242. 1999.

Irrigation Type ( IRTYP) 3 ( Over Canopy) Voss, R. E. Fresh Market Bulb Onion Production in California. U. fo CA Publication 7242. 1999.

Leaching Factor ( FLEACH) 0.1 Estimated Fraction of Water Capacity when Irrigation is Applied ( PCDEPL) 0.12 Adjusted so that infiltration met Voss 61 to 76 cm of water use.

Maximum Rate at which Irrigation is Applied ( RATEAP) 0.2 cm hr 1 PRZM Manual, Table 5.33 ( EPA, 1998)

* EI = 100 ft tons * in/ acre* hr Table 3. PRZM 3.12 Crop Parameters for Kern County, California  Onions Parameter Value Source 15 Initial Crop ( INICRP) 1 Set to one for all crops ( EPA, 2001)

Initial Surface Condition ( ISCOND) 1 Default Number of Different Crops ( NDC) 1 Set to crops in simulation  generally one Number of Cropping Periods ( NCPDS) 30 Set to weather data. Meteorological File  Bakersfield, CA ( W23155)

Maximum rainfall interception storage of crop ( CINTCP) 0.05 PRZM Input Collator ( Burns, 1992)

Maximum Active Root Depth ( AMXDR) 30 cm Voss, R. E. Fresh Market Bulb Onion Production in California. U. fo CA Publication 7242. 1999.

Maximum Canopy Coverage ( COVMAX) 80 Estimated based on aerial photography Soil Surface Condition After Harvest ( ICNAH) 1 Voss, R. E. 1999. Fresh Market Bulb Onion Production in California. U. fo CA Publication 7242.

Date of Crop Emergence ( EMD, EMM, IYREM) 11/ 01 PIC Recommended dates adjusted according to RUSLE Project planting dates.

Date of Crop Maturity ( MAD, MAM, IYRMAT) 01/ 06 PIC Recommended dates adjusted according to RUSLE Project planting dates.

Date of Crop Harvest ( HAD, HAM, IYRHAR) 15/ 06 PIC Recommended dates adjusted according to RUSLE Project planting dates.

Maximum Dry Weight ( WFMAX) 0.0 Set to " 0" Not used in simulation SCS Curve Number ( CN) 92, 85, 86 Gleams Manual Table A. 3, Meadows, no fallow conditions ( USDA, 1990)

Manning's N Value ( MNGN) 0.011 RUSLE Project; C23ONONC; Onions, Fresno CA Conventional Tillage ( USDA, 2000)

USLE C Factor ( USLEC) 0.521  0.732 RUSLE Project; C23ONONC; Onions, Fresno CA Conventional Tillage ( USDA, 2000)

Table 4. PRZM 3.12 Ciervo Soil Parameters for Kern County, California  Onions Parameter Value Verification Source 16 Total Soil Depth ( CORED) 150 cm Number of Horizons ( NHORIZ) 3 ( Base horizons) NRCS, National Soils Characterization Database ( NRCS, 2001)

First, Second and Third Soil Horizons ( HORIZN = 1,2,3)

Horizon Thickness ( THKNS) 12 cm ( HORIZN = 1) 50 cm ( HORIZN = 2) 88 cm ( HORIZN = 3)

Bulk Density ( BD) 1.40 g   cm 3 ( HORIZN = 1) 1.36 g   cm 3 ( HORIZN = 2) 1.17 g   cm 3 ( HORIZN = 3)

Initial Water Content ( THETO) 0.259 cm3 H2O   cm3 soil ( HORIZN = 1) 0.266 cm3 H2O   cm3 soil ( HORIZN = 2) 0.345 cm3 H2O   cm3 soil ( HORIZN = 3)

Compartment Thickness ( DPN) 0.1 cm ( HORIZN = 1) 1.0 cm ( HORIZN = 2) 2.0 cm ( HORIZN = 3)

Field Capacity ( THEFC) 0.259 cm3 H2O   cm3 soil ( HORIZN = 1) 0.266 cm3 H2O   cm3 soil ( HORIZN = 2) 0.345 cm3 H2O   cm3 soil ( HORIZN = 3)

Wilting Point ( THEWP) 0.15 cm3 H2O   cm3 soil ( HORIZN = 1) 0.158 cm3 H2O   cm3 soil ( HORIZN = 2) 0.202 cm3 H2O   cm3 soil ( HORIZN = 3)

Organic Carbon Content ( OC) 0.91% ( HORIZN = 1) 0.43% ( HORIZN = 2) 0.32% ( HORIZN = 3) NRCS, National Soils Characterization Database ( NRCS, 2001) http:// www. statlab. iastate. edu/ s oils/ ssl/) 17 EPA. 1985. Field Agricultural Runoff Monitoring ( FARM) Manual, ( EPA/ 600/ 3 85/ 043) Environmental Research Laboratory, U. S. Environmental Protection Agency, Athens, GA.

EPA. 1998. Carsel, R. F., J. C. Imhoff, P. R. Hummel, J. M. Cheplick, and A. S. Donigian, Jr. PRZM 3, A Model for Predicting Pesticide and Nitrogen Fate in the Crop Root and Unsaturated Soil Zones: Users Manual for Release 3.0. National Exposure Research Laboratory, Office of Research and Development, U. S. Environmental Protection Agency, Athens, GA.

EPA. 1999. Jones, R. D., J. Breithaupt, J. Carleton, L. Libelo, J. Lin, R. Matzner, and R. Parker. Guidance for Use of the Index Reservoir in Drinking Water Exposure Assessments. Environmental Fate and Effects Division, Office of Pesticide Programs, U. S. Environmental Protection Agency, Washington. D. C.

EPA. 2001. Abel, S. A. Procedure for Conducting Quality Assurance and Quality Control of Existing and New PRZM Field and Orchard Crop Standard Scenarios. Environmental Fate and Effects Division, Office of Pesticide Programs, U. S. Environmental Protection Agency, Washington, D. C.

Haan, C. T. and B. J. Barfield. 1978. Hydrology and Sedimentology of Surface Mined Lands. Office of Continuing Education and Extension, College of Engineering, University of Kentucky, Lexington, Kentucky 40506. pp. 286.

USDA. 1990. Davis, F. M., R. A. Leonard, W. G. Knisel. GLEAMS User Manual, Version 1.8.55. USDA ARS Southeast Watershed Research Laboratory, Tifton GA. SEWRL 030190FMD.

USDA. 2000. Revised Universal Soil Loss Equation ( RUSLE) EPA Pesticide Project. U. S. Department of Agriculture, National Resources Conservation Service ( NRCS) and Agricultural Research Service ( ARS).

Voss, R. E. and K. S. Mayberry1999. Fresh Market Bulb Onion Production In California. Vegetable Research and Information Center, Vegetable Production Series, University of California, Division of Agriculture and Natural Resources. Publication 7242. 18 PRZM/ EXAMS GEORGIA ONION Scenario Background Information The field used to represent Vidalia or Sweet Onion production in Georgia is located in Toombs County in Southeastern Georgia. Vidalia Onion can only be legally grown in Southeastern Georgia, in the counties of: Appling, Bacon, Jeff Davis, Montgomery, Tattnall, Telfair, Toombs, Truetlen and Wheeler, and in parts of Dodge, Jenkins, Laurens, Long, Pierce, Screven, and Wayne Counties ( Federal Market Order 955) .

Toombs County, Georgia is representative of the Vidalia onion growing region of Southeastern Georgia. Toombs County is located in the Southern Coastal Plain ( MLRA 133A) as are many of the Vidalia Onion growing counties. However some of these counties ( i. e., Bacon, Wayne) also extend into Atlantic Coastal Flatwoods ( MLRA 153A).

According to the 1999 2001 ( NASS, http:// www. usda. gov/ nass/ pubs/ agr02/ 02_ ch4. pdf) Georgia is a major producer of onions. Vidalia onions are typically planted from mid September ( Sept. 20) through mid October ( Oct. 20) and harvesting begins in mid June ( June 15). Onions are cool season, biennial plants that are commercially grown as an annual. Most onions are direct seeded, but transplants are used in some fall planted fields for an earlier harvest of short day and intermediate day varieties and to achieve uniform , jumbo sized bulbs. Seeds are planted into 6 foot wide raised beds, with a 4 to 6 inch within row spacing and 10 to 18 inch spacing between rows ( Granberry and Kelly, 2000). Distribution of rows across beds varies depending on irrigation method and planter. All commercial grown onions in Georgia are irrigated ( Harrison, 2001). Irrigation should be light and frequent until the onion plants are established. The onion has a shallow root system, with most of the roots in the top 12 inches of soil. Onions continue to grow new roots ( 3 to 4 per week) throughout the entire growing season. Maintaining proper soil moisture in the upper 3 to 4 inches of the soil is critical for continuous root growth and for supplying the needs of the foliage and bulb. Depending upon soil type, temperature, wind velocity and rainfall, 0.10 to 0.25 inches of irrigation may be required daily. Boyhan et al. ( 1999) and Granberry and Kelley ( 2000) provide more specific information concerning the irrigation of onions in Georgia). Between 10 and 12 inches of irrigation water were reportedly applied vegetable crops in Georgia, during the year 2000 ( Harrison, 2001). The irrigation routine was used in PRZM. An overhead sprinkler system is used. The PRZM variables FLEACH and PCDEPL were set to 0.05. These values were estimated by trail an error, to obtain an " irrigation amount" within the range stated above. PRZM includes irrigation" as infiltration into first soil compartment. Irrigation was estimated as the difference of water entering the surface layer for the irrigated scenario compared to the no irrigated ( PRZM variable INFL compartment 1). For the 30 years of data used in the simulation ( 1961 1990), irrigation ranged from 3.2 to 14.5 inches, with an average of 8.3 inches ( CV% = 31.4).

Onions can be grown on a wide range of soils. The soil selected to represent the field is Clarendon. Clarendon loamy sand is a fine loamy, siliceous, semiactive, thermic Plinthaquic Paleudults. These soils are often used for growing tobacco, cotton, corn, soybeans, small grain, and pasture grasses. Forested areas are mostly pine with scattered hardwoods. The Clarendon series consists of very deep, moderately well drained, slow runoff, loamy soils that formed in marine sediments. The Clarendon 19 loamy sand has moderately slow permeability. Slopes range from 0 to 6 percent. The soil extends along the Coastal Plain of Alabama, Florida, Georgia, and South Carolina. The series is of large extent in MLRA 133A and 153A. Clarendon loamy sand is a Hydrologic Group C soil. The Clarendon soil was selected, because it is geographically associated with the competing soil Tifton loamy sand ( Hydrologic Group B) which is also a suitable onion soil. Granberry and Kelley, ( 2000) indicated that Tifton soils are found in the Vidalia onion growing area and is well suited for onion production. The use and vegetation between the two series are similar.

Metfile: W03822. dvf ( Savannah, GA)

Table 1. PRZM 3.12 Climate and Time Parameters for Southeastern Georgia  Onions Parameter Value Source Starting Date January 1, 1961 Meteorological File  Savannah, GA ( W03822)

Ending Date December 31, 1990 Meteorological File  Savannah, GA ( W03822)

Pan Evaporation Factor ( PFAC) 0.75 PRZM Manual Figure 5.1 ( EPA, 1998)

Snowmelt Factor ( SFAC) 0.15 cm C 1 PRZM Manual Table 5.1 ( EPA, 1998)

Minimum Depth of Evaporation ( ANETD) 30 cm PRZM Manual Figure 5.2 ( EPA, 1998)

Table 2. PRZM 3.12 Erosion and Landscape Parameters for Southeastern Georgia  Onions Parameter Value Source Method to Calculate Erosion ( ERFLAG) 4 ( MUSS) PRZM Manual ( EPA, 1998)

USLE K Factor ( USLEK) 0. 1 tons EI 1* PRZM Input Collator ( Burns, 1992) and FARM Manual ( EPA, 1985)

USLE LS Factor ( USLELS) 0.44 Haan and Barfield, 1979 USLE P Factor ( USLEP) 0.5 PRZM Manual ( EPA, 1998)

Field Area 172 ha Surface area of Shipman Reservoir watershed ( EPA, 20 ( AFIELD) 1999)

NRCS Hyetograph ( IREG) 4 PRZM Manual Figure 5.12 ( EPA, 1998)

Slope ( SLP) 3% Mid point of the Soil Series, Clarendon Loamy Sand Hydraulic Length ( HL) 600 m Shipman Reservoir ( EPA, 1999)

* EI = 100 ft tons * in/ acre* hr Table 3. PRZM 3.12 Crop Parameters for Southeastern Georgia  Onions Parameter Value Source Initial Crop ( INICRP) 1 Set to one for all crops ( EPA, 2001)

Initial Surface Condition ( ISCOND) 1 Boyhan, Granberry, and Kelley, University of Georgia Circular 821 ( 5/ 99)

Number of Different Crops ( NDC) 1 Set to crops in simulation  generally one Number of Cropping Periods ( NCPDS) 30 Set to weather data. Meteorological File  Savannah, GA ( W03822)

Maximum rainfall interception storage of crop ( CINTCP) 0.1 cm Estimated from PRZM3 Manual Table 5 4, assuming light density Maximum Active Root Depth ( AMXDR) 35 cm Estimated based on Onion Production Guide, University of Georgia Bulletin 1198; July, 2001 Maximum Canopy Coverage ( COVMAX) 80 Estimated Soil Surface Condition After Harvest ( ICNAH) 1 University of Georgia Bulletin 1198, July, 2001; " Harrison, 2001. Bulletin 1198 University of Georgia July 2001 Irrigating Sweet Onions in GA", Granberry and Kelley, 2000 Circular 801 University of Georgia; and RUSLE information Date of Crop Emergence ( EMD, EMM, IYREM) 15/ 09 RUSLE Project planting dates and Circulars 801 and 821 and Bulletin 1198.

Date of Crop Maturity ( MAD, MAM, IYRMAT) 01/ 06 RUSLE Project planting dates and Circulars 801 and 821 and Bulletin 1198..

Date of Crop Harvest ( HAD, HAM, IYRHAR) 15/ 06 RUSLE Project planting dates and Circulars 801 and 821 and Bulletin 1198.. 21 Table 3. PRZM 3.12 Crop Parameters for Southeastern Georgia  Onions Parameter Value Source Maximum Dry Weight ( WFMAX) 0.0 Set to " 0" Not used in simulation SCS Curve Number ( CN) 91, 86, 87 Gleams Manual Table A. 3, Meadows, no fallow conditions ( USDA, 1990)

91" GLEAMS Manual Table A 3; Fallow = SR  middle or average value 86" GLEAMS Manual Table A 3; Row Crop = SR poor, Cropping and Residue = Row Crop poor" 87" GLEAMS Manual Table A 3; Row Crop = SR/ poor, Cropping and Residue = Row Crop SR/ poor"

Manning's N Value ( MNGN) 0.011 RUSLE Project; Pb9ONONC, Onions, Augusta, GA Conventional Tillage ( USDA, 2000)

USLE C Factor ( USLEC) 0.592  0.902 RUSLE EPA Pesticide Project: Pb9ONONC; Onions, Augusta, GA Conventional Tillage"

Table 4. PRZM 3.12 Clarendon Loamy Sand Soil Parameters for Southeastern Georgia  Onions Parameter Value Verification Source Total Soil Depth ( CORED) 100 cm Number of Horizons ( NHORIZ) 3 ( Base horizons) NRCS, National Soils Characterization Database ( NRCS, 2001)

First, Second and Third Soil Horizons ( HORIZN = 1,2,3)

Horizon Thickness ( THKNS) 10 cm ( HORIZN = 1) 30 cm ( HORIZN = 2) 60 cm ( HORIZN = 3)

Bulk Density ( BD) 1.6 g   cm 3 ( HORIZN = 1) 1.6 g   cm 3 ( HORIZN = 2) 1.7 g   cm 3 ( HORIZN = 3)

Initial Water Content 0.115 cm3 H2O   cm3 soil PIRANHA Version 3.0 PRZM Input Collator PIC Version 2.0 22 ( THETO) ( HORIZN = 1) 0.115 cm3 H2O   cm3 soil ( HORIZN = 2) 0.173 cm3 H2O   cm3 soil ( HORIZN = 3)

Compartment Thickness ( DPN) 0.1 cm ( HORIZN = 1) 1.0 cm ( HORIZN = 2) 5.0 cm ( HORIZN = 3)

Field Capacity ( THEFC) 0.115 cm3 H2O   cm3 soil ( HORIZN = 1) 0.115 cm3 H2O   cm3 soil ( HORIZN = 2) 0.173 cm3 H2O   cm3 soil ( HORIZN = 3)

Wilting Point ( THEWP) 0.035 cm3 H2O   cm3 soil ( HORIZN = 1) 0.035 cm3 H2O   cm3 soil ( HORIZN = 2) 0.093 cm3 H2O   cm3 soil ( HORIZN = 3)

Organic Carbon Content ( OC) 1.74% ( HORIZN = 1) 1.74% ( HORIZN = 2) 0.174% ( HORIZN = 3)

Table 5. PRZM 3.12 Irrigation Parameters for Southeastern Georgia  Onions Parameter Value Source Irrigation Flag ( IRFLAG) 2 Irrigate during cropping period ( Harrison 2001) Harrison, 2001. Irrigating Sweet Onions in Georgia. In: ( ed.) G. Boyhan et al. Onion Production Guide Bulletin 1198 University of Georgia. Granberry and Kelley, 2000. Dry Bulb Onions, Circular 801 Coop. Exten. Service, University of 23 Georgia Irrigation Type ( IRTYP) 3 Over canopy Harrison, 2001. Irrigating Sweet Onions in Georgia. In: ( ED.) G. Boyhan et al. Onion Production Guide. Bulletin 1198 University of Georgia. Granberry and Kelley, 2000. Dry Bulb Onions, Circular 801 Coop. Exten. Service, University of Georgia Leaching Factor ( FLEACH) 0.05 Estimated Fraction of water capacity to apply irrigation ( PCDEPL) 0.05 Adjusted to meet irrigation objective. Harrison, 2001. Irrigating Sweet Onions in Georgia. In: ( ED.) G. Boyhan et al. Onion Production Guide. Bulletin 1198 University of Georgia. Granberry and Kelley, 2000. Dry Bulb Onions, Circular 801 Coop. Exten. Service, University of Georgia Maximum rate at which irrigation is applied ( RATEAP)) 5 cm hr 1 PRZM3  Manual Table 5.33 ( EPA, 1998)

Boyhan, G. E. and D. M. Granberry, and W. T. Kelley. 1999. Green Onions. Circular 821. Cooperative Extension Service, University of Georgia.

Bird, S., M. Cheplick, R. F. Carsel and M. Fendley. 1992. PIRANHA Version 3.0, PRZM Input Collator, PIC Version 2.0, Environmental Research Laboratory U. S. Environmental Protection Agency. Athens, Georgia Burns, L. A. et al. 1992. Pesticide and Industrial Chemical Risk ANalysis and Hazard Assessment Environmental Research Laboratory U. S. Environmental Protection Agency. Athens, Georgia EPA. 1985. Field Agricultural Runoff Monitoring ( FARM) Manual, ( EPA/ 600/ 3 85/ 043) Environmental Research Laboratory, U. S. Environmental Protection Agency, Athens, GA.

EPA. 1998. Carsel, R. F., J. C. Imhoff, P. R. Hummel, J. M. Cheplick, and A. S. Donigian, Jr. PRZM 3, A Model for Predicting Pesticide and Nitrogen Fate in the Crop Root and Unsaturated Soil Zones: Users Manual for Release 3.0. National Exposure Research Laboratory, Office of Research and Development, U. S. Environmental Protection Agency, Athens, GA. 24 EPA. 1999. Jones, R. D., J. Breithaupt, J. Carleton, L. Libelo, J. Lin, R. Matzner, and R. Parker. Guidance for Use of the Index Reservoir in Drinking Water Exposure Assessments. Environmental Fate and Effects Division, Office of Pesticide Programs, U. S. Environmental Protection Agency, Washington. D. C.

EPA. 2001. Abel, S. A. Procedure for Conducting Quality Assurance and Quality Control of Existing and New PRZM Field and Orchard Crop Standard Scenarios. Environmental Fate and Effects Division, Office of Pesticide Programs, U. S. Environmental Protection Agency, Washington, D. C.

Granberry, D. M. and W. T. Kelley. 2000. Dry Bulb Onions. Circular 801 ( January 2000). Cooperative Extention Service. University of Georgia.

Haan, C. T. and B. J. Barfield. 1978. Hydrology and Sedimentology of Surface Mined Lands. Office of Continuing Education and Extension, College of Engineering, University of Kentucky, Lexington, Kentucky 40506. pp. 286.

Harrison, K. 2001. Irrigation Sweet Onions in Georgia. In ( eds). G. Boyhan et al. Onion Production Guide. Bulletin 1198, Cooperative Extension Service, University of Georgia.

Harrison, K. A. and A. W. Tyson. 2001. Georgia Irrigation Amount by Crop. Irrigation Survey for Georgia. p. 421 424. In K. J. Hatcher ( ed.) Proceedings of the 2001 Georgia Resources Conference. Univ. of Georgia Institute of Ecology, Athens, GA ( http:// nespal. org/ agwateruse/ facts/ survey/ amtbycrop. asp) .

USDA. 1990. Davis, F. M., R. A. Leonard, W. G. Knisel. GLEAMS User Manual, Version 1.8.55. USDA ARS Southeast Watershed Research Laboratory, Tifton GA. SEWRL 030190FMD.

USDA. 2000. Revised Universal Soil Loss Equation ( RUSLE) EPA Pesticide Project. U. S. Department of Agriculture, National Resources Conservation Service ( NRCS) and Agricultural Research Service ( ARS).


[Federal Register Volume 76, Number 100 (Tuesday, May 24, 2011)]
[Notices]
[Pages 30231-30232]
[FR Doc No: 2011-12745]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2011-24]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petitions or their final disposition.

DATES: Comments on these petitions must identify the petition docket
number involved and must be received on or before June 13, 2011.

ADDRESSES: You may send comments identified by Docket Number FAA-2011-
0370 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Tyneka L. Thomas,<PHONE_NUMBER>, or
Keira Jones,<PHONE_NUMBER>, Office of Rulemaking, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on May 18, 2011.
Dennis Pratte,
Acting Director, Office of Rulemaking.

Petition For Exemption

    Docket No.: FAA-2011-0370.
    Petitioner: Chrysler Aviation, Inc.
    Section of 14 CFR Affected: Sec.  135.267(c).
    Description of Relief Sought: Chrysler Aviation, Inc. (Chrysler
Aviation), requests an exemption from Sec.  135.267(c) to allow
Chrysler to extend the duty limit from 14 hours to 16 hours in the
event of a bona fide medical emergency.

[FR Doc. 2011-12745 Filed 5-23-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Notices]
[Pages 13980-13981]
[FR Doc No: 2018-06625]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC18-76-000.
    Applicants: Entergy Arkansas, Inc., Entergy Mississippi, Inc.
    Description: Joint Application of Entergy Arkansas, Inc., et al.
for Approval under Section 203 of the Federal Power Act.
    Filed Date: 3/27/18.
    Accession Number: 20180327-5079.
    Comments Due: 5 p.m. ET 4/17/18.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER18-406-001.
    Applicants: Brunner Island, LLC.
    Description: Compliance filing: Reactive Service Rate Schedule
Compliance Filing to be effective 2/25/2018.
    Filed Date: 3/27/18.
    Accession Number: 20180327-5075.
    Comments Due: 5 p.m. ET 4/17/18.

    Docket Numbers: ER18-564-001.
    Applicants: South Central MCN LLC.
    Description: Compliance filing: Wholesale Distribution ADIT
Deficiency Response to be effective 1/1/2018.
    Filed Date: 3/27/18.
    Accession Number: 20180327-5158.
    Comments Due: 5 p.m. ET 4/17/18.

    Docket Numbers: ER18-1181-000.
    Applicants: San Diego Gas & Electric, Energia Sierra Juarez 2 U.S.,
LLC.
    Description: Joint Application of San Diego Gas & Electric Company,
et al for Approval of Affiliate Transaction Pursuant to Section 205 of
the Federal Power Act.
    Filed Date: 3/26/18.
    Accession Number: 20180326-5267.
    Comments Due: 5 p.m. ET 4/16/18.

    Docket Numbers: ER18-1182-000.
    Applicants: System Energy Resources, Inc.
    Description: Sec.  205(d) Rate Filing: UPSA Amendment to Reflect
Tax Cuts and Jobs Act of 2017 to be effective 6/1/2018.
    Filed Date: 3/27/18.
    Accession Number: 20180327-5074.
    Comments Due: 5 p.m. ET 4/17/18.

    Docket Numbers: ER18-1183-000.
    Applicants: Delta Solar Power I, LLC.
    Description: Baseline eTariff Filing: Initial Market Based Rate
Tariff to be effective 5/21/2018.
    Filed Date: 3/22/18.
    Accession Number: 20180322-5321.
    Comments Due: 5 p.m. ET 4/12/18.

    Docket Numbers: ER18-1184-000.
    Applicants: Delta Solar Power II, LLC.
    Description: Baseline eTariff Filing: Initial Market Based Rate
Tariff to be effective 5/21/2018.
    Filed Date: 3/22/18.
    Accession Number: 20180322-5322.
    Comments Due: 5 p.m. ET 4/12/18.

    Docket Numbers: ER18-1185-000.
    Applicants: Duke Energy Progress, LLC.
    Description: Sec.  205(d) Rate Filing: DEP-PJM 2nd Amended and
Restated JOA Concurrence to be effective 4/1/2018.
    Filed Date: 3/27/18.
    Accession Number: 20180327-5099.
    Comments Due: 5 p.m. ET 4/17/18.

    Docket Numbers: ER18-1186-000.
    Applicants: Turtle Creek Wind Farm LLC.
    Description: Baseline eTariff Filing: Market Based Rate Application
to be effective 5/27/2018.
    Filed Date: 3/27/18.
    Accession Number: 20180327-5101.
    Comments Due: 5 p.m. ET 4/17/18.

    Docket Numbers: ER18-1187-000.
    Applicants: Eagle's View Partners, Ltd.
    Description: Baseline eTariff Filing: Eagles View MBR Application
to be effective 3/28/2018.
    Filed Date: 3/27/18.
    Accession Number: 20180327-5102.
    Comments Due: 5 p.m. ET 4/17/18.

    Docket Numbers: ER18-1188-000.
    Applicants: Prairie Queen Wind Farm LLC.
    Description: Baseline eTariff Filing: Market Based Rate Application
to be effective 5/27/2018.
    Filed Date: 3/27/18.
    Accession Number: 20180327-5103.
    Comments Due: 5 p.m. ET 4/17/18.

    Docket Numbers: ER18-1189-000.
    Applicants: Meadow Lake Wind Farm VI LLC.
    Description: Baseline eTariff Filing: Market Based Rate Application
to be effective 5/27/2018.
    Filed Date: 3/27/18.
    Accession Number: 20180327-5110.
    Comments Due: 5 p.m. ET 4/17/18.

    Docket Numbers: ER18-1190-000.
    Applicants: Entergy Arkansas, Inc.
    Description: Sec.  205(d) Rate Filing: Amended Distribution
Agreement to Reflect Tax Cuts and Jobs Act of 2017 to be effective 6/1/
2018.
    Filed Date: 3/27/18.
    Accession Number: 20180327-5111.
    Comments Due: 5 p.m. ET 4/17/18.

    Docket Numbers: ER18-1191-000.
    Applicants: Wisconsin Public Service Corporation.

    Description: Sec.  205(d) Rate Filing: Notice of Termination for SA
43 to be effective 3/1/2018.
    Filed Date: 3/27/18.
    Accession Number: 20180327-5136.
    Comments Due: 5 p.m. ET 4/17/18.

    Docket Numbers: ER18-1192-000.
    Applicants: The Connecticut Light and Power Company.
    Description: Sec.  205(d) Rate Filing: Interconnection Agreement
with Fusion Solar Center, LLC to be effective 3/27/2018.
    Filed Date: 3/27/18.
    Accession Number: 20180327-5137.
    Comments Due: 5 p.m. ET 4/17/18.

    Docket Numbers: ER18-1193-000.
    Applicants: Wisconsin Electric Power Company.
    Description: Sec.  205(d) Rate Filing: Notice of Termination for RS
106 to be effective 3/1/2018.
    Filed Date: 3/27/18.
    Accession Number: 20180327-5139.
    Comments Due: 5 p.m. ET 4/17/18.

    Docket Numbers: ER18-1194-000.
    Applicants: CSOLAR IV West, LLC.
    Description: Sec.  205(d) Rate Filing: Market-Based Rate Tariff
Revisions to be effective 3/28/2018.
    Filed Date: 3/27/18.
    Accession Number: 20180327-5157.
    Comments Due: 5 p.m. ET 4/17/18.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES18-24-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Application of Midcontinent Independent System
Operator, Inc. under Section 204 of the Federal Power Act for
Authorization to Issue Securities.
    Filed Date: 3/26/18.
    Accession Number: 20180326-5266.
    Comments Due: 5 p.m. ET 4/16/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 27, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-06625 Filed 3-30-18; 8:45 am]
 BILLING CODE 6717-01-P


To:		Mike McCorison, Dee Morse

From:		Howard Gebhart

Subject:	Review of Revised CALPUFF Modeling – Big West of California
LLC

Date:		February 6, 2007

	This reports provides a review of the updated Class I modeling impact
analysis for the proposed Big West of California LLC Clean Fuels Project
(CFP).  The CFP is designed to increase the production of gasoline and
diesel fuel that meets California fuel specifications at the Big West
refinery, located 2.5 northwest of Bakersfield, CA (formerly Shell Oil
Company).  Although there will be new process units associated with the
CFP, the project does not increase the crude oil throughput for the
refinery.

	The Class I modeling analysis addresses potential impacts at Dome Land
and San Rafael Wilderness (managed by USDA – Forest Service) as well
as Sequoia National Park (managed by National Park Service).  The
closest approach of each area is as follows:  Dome Land 82 km, San
Rafael 85 km, and Sequoia 107 km.

	The major changes from the March 2006 modeling analysis were to
increase nitrogen oxides (NOx) and sulfur dioxide (SO2) emissions from
the fluid catalytic cracking unit (FCCU).  The FCCU NOx emissions
increased from 202 to 404 lb/day

(20 ppmv to 40 ppmv).  The FCCU SO2 emissions increased from 281 to 703
lb/day

(20 ppmdv to 50 ppmdv).  The increased emissions reflect a higher
short-term emission rate, whereas the March 2006 CALPUFF modeling used
the proposed best available control technology (BACT) emissions rate,
which was based on the annual mean.  The FCCU is one of the larger
emission sources associated with the Clean Fuels Project.

	Other emission changes associated with the CFP included a small
increase in emissions at the ground flare, plus decreases in emissions
at the MHC Heater 14-H2 and the diesel fire water pump engine.  Also,
two small sources (utility boiler and elevated alky flare) were removed
from the modeling as these sources are no longer included with the
project.

 	Other than the changes in emissions described above, the modeling
procedures appear for the most part to be unchanged from the March 2006
modeling analysis.  The Class I modeling followed the CALPUFF-Lite
screening procedure, based on five years of meteorological inputs from
the Bakersfield airport.  The new modeling used 1999, 2000, 2001, 2003,
and 2004.  2001 was omitted due to extensive “missing” data for wind
speed in the Bakersfield airport data.  The March 2006 modeling used the
five year period 2000-2004 (including 2001 with the apparent data
recovery problems.)

All CALPUFF modeling inputs were consistent with the recommended default
values and Federal Land Manager (FLM) guidance.  The emissions inputs
included particle speciation and 10 ppb was selected for the background
ammonia concentration.  Visibility calculations used MVISBK = 6 (normal
for CALPUFF-Lite screening) along with the FLAG “natural background”
aerosol concentration values.  Particle speciation was incorporated by
using a 2.46 extinction coefficient for the PM mass, which represents
the weighted mean extinction for the various PM constituents.  Overall,
the modeling appears to have been done correctly and follows FLM
guidance.

	Modeling results are based on information submitted in a revised PSD
application from the applicant’s consultant (Ashworth Leininger Group)
dated December 2006.

	Based on the reported CALPUFF results, ambient concentrations of
modeled pollutants (NOx, PM-10, and SO2), were below the applicable
“significant impact levels” for all Class I areas modeled.  For the
SO2 modeling, all sulfur input to the system were modeled as SO2.

	I noticed some minor problems with the PM-10 modeling, but these errors
do not appear to have affected the modeling results and conclusions.
First, the PM-10 inventory was modeled as six separate size classes in
order to allow for deposition of the PM-10 mass.  While this is
permissible, the deposition effect in the Big West CALPUFF study is
probably small, given that 82% of the PM-10 mass was modeled as 0.625
microns or smaller.  The deposition error occurred in that the largest
size was chosen as the “mass mean diameter” for each of the six size
classes (e.g., the PM mass for less than

0.625 microns was all modeled at 0.625 microns diameter).  This would
tend to overestimate PM-10 deposition and as such, underestimate PM-10
concentration impacts.  The other PM-10 modeling error was that the
secondary sulfate and nitrate formation were not counted in the PM-10
mass for the increment modeling.  Nevertheless, the

PM-10 concentrations were reported to be at most 25% of the applicable
SIL, so these minor errors were unlikely to change to conclusions
regarding PM-10 emissions and their impact on Class I PSD increment
consumption.

The total nitrogen deposition values were less than the FLM deposition
analysis threshold (DAT) of 0.005 kg/ha-yr at all Class I areas modeled.
 Nitrogen deposition included all of the relevant pollutant species,
including deposition of ammonium sulfate.

For sulfur deposition, the modeled impacts slightly exceeded the DAT,
with maximum annual predictions of 0.0056 kg/ha-yr for Dome Land and
0.0052 kg/ha-yr at San Rafael.  Dome Land showed sulfur deposition above
the DAT for three of the five years modeled and San Rafael was over the
sulfur deposition DAT for only one of the five years modeled.  For the
five-year average, the Dome Land sulfur deposition was 0.005054 kg/ha-yr
and the San Rafael sulfur deposition was 0.00473 kg/ha-yr.  The

five-year average calculations shown above assume that the worst-case
receptor in each Class I area is the same for each year, which is not
necessarily the case.  The sulfur deposition was less than 0.005
kg/ha-yr at Sequoia in all five years.

	The visibility modeling predicted a small number of days in excess of
the

5% threshold (based on change in extinction coefficient) at each Class I
area modeled.  The frequency of impact was 3.2 days per year at Dome
Land, with a maximum change in extinction of 6.76%.  San Rafael modeled
2.4 days/yr above 5% change in visibility, with a maximum change in
extinction of 6.59%.  At Sequoia, the frequency of visibility impact
above 5% was less than 1 day per year, with a maximum change of 6.23%.
The visibility modeling included emissions of primary sulfate, with the
SO2 emissions reduced slightly to account for the percentage of total
sulfur modeled as sulfate.  This adjustment is appropriate as it
maintains a sulfur balance in the emissions inventory.

	Although the CALPUFF-Lite visibility modeling predicted a few days
above the 5% threshold for change in extinction, the frequency of these
exceedances is small

(3 days per year of less) with a magnitude only marginally above the 5%
visibility impact threshold.  Likewise the sulfur deposition is
marginally above the 0.005 kg/ha-yr SIL. Although any decision regarding
the significance of such impacts is reserved to the FLM, other cases
where modeled impacts were slightly above the applicable SIL have been
judged to be insignificant.  In addition, the modeled impacts were all
computed using the CALPUFF-Lite screening procedure.  In all
probability, if a refined CALPUFF modeling study were performed, the
impacts would be lower and would fall within the established SILs.
However, the FLM may still request a refined CALPUFF modeling study for
this project at its discretion.

	Please contact me at 970/484-7941 or by email at   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>if there
are any questions regarding this review.

Howard


[Federal Register Volume 84, Number 105 (Friday, May 31, 2019)]
[Notices]
[Pages 25281-25282]
[FR Doc No: 2019-11411]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0001]

Improving the Implementation of Risk-Based Monitoring Approaches
of Clinical Investigations; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA, we) is announcing the
following pubic workshop entitled ``Improving the Implementation of
Risk-Based Monitoring Approaches of Clinical Investigations.'' This
public workshop is convened by Duke University's Robert J. Margolis,
MD, Center for Health Policy and supported by a cooperative agreement
with FDA. The purpose of the public workshop is to capture stakeholder
experiences with risk-based approaches to monitoring of clinical
investigations and gather stakeholder input on opportunities to further
the implementation of risk-based approaches to monitoring.

DATES: The public workshop will be held on July 17, 2019, from 8:30
a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for
registration date and information.

ADDRESSES: The public workshop will be held at the Marriott Marquis
Washington, DC at 901 Massachusetts Ave. NW, in Washington DC. For
additional travel and hotel information, please refer to the following
website: https://healthpolicy.duke.edu/events/improving-implementation-risk-based-monitoring-approaches-clinical-trials. There will also be a
live webcast for those unable to attend the meeting in person (see
Streaming Webcast of the Public Workshop).

FOR FURTHER INFORMATION CONTACT: Raymond Chiang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2232, Silver Spring, MD 20993, 301-796-
1940<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    To support greater implementation of risk-based approaches to
monitoring (RBM) of clinical investigations, FDA issued draft guidance
for industry in March 15, 2019 (84 FR 9531) entitled ``A Risk-Based
Approach to Monitoring of Clinical Investigations: Questions and
Answers, `` which is available at https://www.fda.gov/media/121479/download. This draft guidance expands on the guidance for industry
entitled, ``Oversight of Clinical Investigations--A Risk-Based Approach
to Monitoring'' (August 2013) by providing additional guidance to
facilitate sponsors' implementation of risk-based monitoring.
    Traditionally, sponsors and research organizations have depended
upon on-site monitoring and 100 percent source data verification for
each clinical site, an approach that is resource intensive and may
contribute to increased clinical trial costs. Adoption of RBM could
lead to improvements to human subject protections, data integrity, and
the efficiency of clinical investigations.
    Data suggest that RBM has not yet been widely implemented.
Therefore, FDA is seeking additional feedback from stakeholders on the
challenges, barriers, and enablers that might be impacting the adoption
of RBM. The public workshop addressed in this document is being held to
capture stakeholder experiences with risk-based approaches to
monitoring of clinical investigations and to gather stakeholder input
on ways to improve the implementation of risk-based approaches to
monitoring.

II. Topics for Discussion at the Public Workshop

    During the public workshop, speakers and participants will cover a
range of issues related to implementation of risk-based approaches to
monitoring. Topics for discussion will include, and are not limited to,
challenges to implementation of RBM, enablers to support implementation
of RBM, and lessons learned from strategies employed to implement RBM.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, complete the
registration form at https://healthpolicy.duke.edu/events/improving-implementation-risk-based-monitoring-approaches-clinical-trials. Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register online by July 16, 2019, by 5 p.m. Eastern Time.
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
registered. If time and space permit, onsite registration on the day of
the public workshop will be provided beginning at 8 a.m. We will let
registrants know if registration closes before the day of the public
workshop.
    If you need special accommodations due to a disability, please
contact the Duke-Margolis Center for Health Policy (phone: 202-791-
9561, email<EMAIL_ADDRESS>no later than July 10, 2019.
    Streaming Webcast of the Public Workshop: This public workshop will
also be webcast and archived video footage will be available at the
event website. Persons interested in viewing the live webcast are
encouraged to register in advance (see Registration). The live webcast
will also be available at the website above on the day of the event
without preregistration. Registered webcast participants will be sent
technical system requirements in advance of the event. It is
recommended that you review these technical system requirements prior
to joining the streaming webcast of the public workshop.
    FDA has verified the website addresses in this document, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.
    Meeting Materials: All event materials will be provided to
registered attendees via email prior to the workshop and will be
publicly available at the Duke-Margolis Center for Health Policy
website: https://healthpolicy.duke.edu/

events/improving-implementation-risk-based-monitoring-approaches-
clinical-trials.
    Transcripts: Please be advised that transcripts of the public
workshop will not be available.

    Dated: May 28, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11411 Filed 5-30-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: June 19, 2008 (Volume 73, Number 119)]
[Notices]
[Page 34922-34923]
[DOCID:fr19jn08-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2210-175]

American Electric Power; Notice of Application for Amendment of
License And Soliciting Comments, Motions to Intervene, and Protests

June 12, 2008.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Request to increase water withdrawal for
municipal use.
    b. Project No.: 2210-175.
    c. Date Filed: May 27, 2008.
    d. Applicant: American Electric Power.
    e. Name of Project: Smith Mountain.
    f. Location: Smith Mountain Lake on the Roanoke River, Bedford
County, Virginia.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Frank M. Simms, American Electric Power, P.O.
Box 2021, Roanoke, Virginia 24022-2121<PHONE_NUMBER>.
    i. FERC Contact: Derek Crane<EMAIL_ADDRESS>(202) 502-8047.
    j. Deadline for filing comments, motions to intervene and protests:
July 11, 2008.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency. A copy
of any motion to intervene must also be served upon each representative
of the Applicant specified in the particular application.
    k. Description of Request: American Electric Power (AEP) proposes
to grant permission to Bedford County Public Service Authority (BCPSA)
to install a 12-inch diameter, high density polyethylene raw water
intake pipeline and associated intake structure within the Smith
Mountain Project boundary to increase water withdrawn from the Smith
Mountain Project reservoir from an annual average of 0.5 million
gallons per day (mgd) and peak of 0.999 mgd to an annual average of 2.0
mgd with a peak of 2.999 mgd. The proposed withdrawal is for municipal
use by the BCPSA, Bedford County, GA.
    l. Location of the Application: The filing is available for
inspection and reproduction at the Commission's Public Reference Room,
located at 888 First Street, NE., Room 2A, Washington, DC 20426 or by
calling<PHONE_NUMBER>, or by calling<PHONE_NUMBER>. This filing may
also be viewed on the Commission's Web site at http://ferc.gov using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docsfiling/esubscription.asp to
be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
call 1-866-208-3676 or e-mail<EMAIL_ADDRESS>for TTY, call
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Any filing must bear in all capital letters the title
``COMMENTS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as applicable,
and the Project Number of the particular application to which the
filing refers.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.
    q. Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(I)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov
under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-13809 Filed 6-18-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 10 (Tuesday, January 16, 2018)]
[Notices]
[Page 2248]
[FR Doc No: 2018-00504]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-610, OMB Control No. 3235-0707]

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Form SF-1

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form SF-1 (17 CFR 239.44) is the registration statement for non-
shelf issuers of assets-backed securities register a public offering of
their securities under the Securities Act of 1933 (15 U.S.C. 77a et
seq.). The information collected is intended to ensure that the
information required to be filed by the Commission permits verification
of compliance with securities law requirements and assures the public
availability of such information in the asset-backed securities market.
Form SF-1 takes approximately 1,380 hours per response and is filed by
approximately 6 respondents. We estimate that 25% of the 1,380 hours
per response (345 hours) is prepared by the registrant for a total
annual reporting burden of 2,070 hours (345 hours per response x 6
responses).
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Please direct your written comment to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE, Washington, DC 20549 or send an email
to: [email protected].

    Dated: January 9, 2018.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-00504 Filed 1-12-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Proposed Rules]
[Page 11611]
[FR Doc No: 2013-03732]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211

[Docket No. FDA-2011-N-0920]
RIN 0910-AG36

Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Human Food; Extension of Comment Period
for Information Collection Provisions

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period for information
collection provisions.

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

SUMMARY: The Food and Drug Administration (FDA or ``we'') is extending
the comment period for the information collection related to the
proposed rule on ``Current Good Manufacturing Practice and Hazard
Analysis and Risk-Based Preventive Controls for Human Food'' that
appeared in the Federal Register of January 16, 2013. In the preamble
to the proposed rule, FDA requested comments on the information
collection provisions that are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
We are taking this action in response to requests for an extension to
allow interested persons additional time to submit comments on the
information collection provisions associated with the rule.

DATES: The comment period for the proposed rule published January 16,
2013 (78 FR 3646), is extended. Submit either electronic or written
comments by May 16, 2013.

ADDRESSES: To ensure that comments on information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the title ``Current Good
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive
Controls for Human Food.''

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Picard Dr., PI50-400T,
Rockville, MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 16, 2013 (78 FR 3646), FDA
published a proposed rule entitled ``Current Good Manufacturing
Practice and Hazard Analysis and Risk-Based Preventive Controls for
Human Food'' with a 120-day comment period on the provisions of the
proposed rule and a 30-day comment period on the information collection
provisions that are subject to review by OMB under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). Comments on the provisions
of the rule and on the information collection provisions will inform
FDA's rulemaking to modernize the regulation for ``Current Good
Manufacturing Practice In Manufacturing, Packing, or Holding Human
Food'' and to add requirements for domestic and foreign facilities that
are required to register under the Federal Food, Drug, and Cosmetic Act
to establish and implement hazard analysis and risk-based preventive
controls for human food.
    OMB and FDA have received two requests for a 90-day extension of
the comment period for the information collection provisions of the
proposed rule. The requests conveyed concern that the current 30-day
comment period does not allow sufficient time to develop a meaningful
or thoughtful response to the information collection provisions
submitted to OMB under the Paperwork Reduction Act of 1995.
    We have considered the requests and are extending the comment
period for the information collection for 90 days, until May 16, 2013.
We believe that a 90-day extension allows adequate time for interested
persons to submit comments without significantly delaying rulemaking on
these important issues. A 90-day extension also will make the comment
period for the information collection provisions the same as the
comment period for the provisions of the proposed rule.

II. Request for Comments

    Interested persons may either submit electronic comments regarding
the information collection to<EMAIL_ADDRESS>or fax
written comments to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>. All comments should be
identified with the title ``Current Good Manufacturing Practice and
Hazard Analysis and Risk-Based Preventive Controls for Human Food.''

    Dated: February 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03732 Filed 2-15-13; 8:45 am]
BILLING CODE 4160-01-P