UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D. C., 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES PC Code: 128840, 128848, 129023 DP Barcode: D313182 Date: Jun 21, 2005 MEMORANDUM SUBJECT: Drinking Water Assessment for Imazaquin and its Salts TO: Craig Doty, Chemical Review Manager Special Review Branch Special Review and Registration Division ( 7508C)

FROM: Keara Moore, Environmental Scientist Environmental Risk Branch III Environmental Fate and Effects Division ( 7507C)

THROUGH: Mark Corbin, Senior Environmental Scientist Environmental Risk Branch III Environmental Fate and Effects Division ( 7507C)

APPROVED BY: Daniel Rieder, Branch Chief Environmental Risk Branch III Environmental Fate and Effects Division ( 7507C)

Summary This document reports the Tier II estimated environmental concentrations ( EEC) in drinking water to support the tolerance reassessment process for imazaquin [ 2( 4 Isopropyl 4 methyl 5 oxo 2 imidazolin 2 yl 3 quinolinecarboxylic acid; PC 128848] and its monoammonium and monosodium salts ( PC 128840 & 129023). Because all three compounds dissociate in water to form the carboxylate anion, they are treated concurrently in the following assessment. Except where otherwise noted, " imazaquin" will be used to refer to all three compounds. At this time, no degradates of concern have been identified and only the parent compounds will be considered in this assessment. Imazaquin's primary use is as a broad spectrum herbicide on soybeans. The turf and ornamental use patterns are also considered in this assessment. 2 Concentrations of imazaquin to which humans potentially may be exposed through ingestion of drinking water are assessed through an evaluation of surface water and groundwater monitoring data and modeling. Surface and groundwater monitoring data were available from the United States Geological Survey ( USGS) National Water Quality Assessment ( NAWQA) Program and from an additional USGS study on pesticide concentrations in high use areas in the Midwest. Maximum concentrations of imazaquin in the monitoring data reviewed were 4.89 : g ae/ L in surface water and 0.098 : g ae/ L in groundwater. Because the monitoring studies reviewed are short term or not targeted to detect imazaquin, they are not likely to capture peak concentrations. Modeling is used, therefore, to predict the most conservative concentrations, with monitoring data used to confirm that modeling results are reasonable. EECs in surface water were modeled using PRZM 3.12/ EXAMS 2.98.04 and ground water concentrations were modeled using SCIGROW ( version 2.3). These results are presented in Table 1. Note that all concentrations reported in this assessment are in acid equivalents ( ae) unless otherwise specified.

Table 1. Imazaquin EECs Surface water ( PRZM / EXAMS) Groundwater ( SCIGROW)

Acute ( Peak) Chronic ( Annual average) Acute & Chronic Soybeans Turf  1 app. Turf  2 app. Ornamental 1.8 µ g ae/ L 15.2 µ g ae/ L 20.0 µ g ae/ L 17.4 µ g ae/ L 0.4 µ g ae/ L 5.0 µ g ae/ L 7.6 µ g ae/ L 9.1 µ g ae/ L 3.8 µ g ae/ L 15.6 µ g ae/ L 31.1 µ g ae/ L 15.6 µ g ae/ L Pesticide Use and Application Imazaquin is a broad spectrum herbicide used primarily on soybeans with other minor food uses that include dry beans, lima beans, corn, and peas. It is also used on turf in both commercial and residential settings and on ornamental trees, shrubs, and groundcover. Imazaquin has a number of formulations including Scepter, Squadron, Detail and Backdraft for soybeans and Image for turf and ornamentals. The registrant states that production of all row crop products except Scepter 70DG ( Reg. No. 241 306) has been discontinued. Image formulations ( Reg. Nos. 241 319 and 241 351) are still marketed. Based on data from 1998 through 2003, 200,000 lbs of imazaquin were used annually on soybeans relative to less than 500 lbs for the other minor food uses ( BEAD, 2005), so soybeans ( Scepter 70DG) are the only food use simulated for this document. Sales of Image products for use on turf and ornamentals are approximately 10% of total sales, on a pound a. i. basis ( Imazaquin Sales Report). Both turf and ornamental uses are simulated.

Use of imazaquin on soybeans is limited by the label to the eastern half of the United States. Figure 1 presents a summary of total agricultural imazaquin use, created by the NAWQA Pesticide National Synthesis Project ( USGS, 2003). This map is based on state level estimates of pesticide use rates for individual crops, which have been compiled by the National Center for Food and Agricultural Policy ( NCFAP) for 1995 1998, and on 1997 Census of Agriculture county crop acreage. Imazaquin can only be used on turf in the southern U. S. because of the lack of selectivity for cool season grasses ( Reg. Nos. 241 319 and 241 351). There is no geographic limitation on use for ornamentals, although imazaquin is not to be used on field or tree nurseries ( Reg. No. 241 351). These uses are not represented in Figure 1. 3 Figure 1. Estimated annual agricultural use of imazaquin based on 1995  1998 data. 4 On soybeans, imazaquin may be applied preplant incorporated, preemergence, postemergence, or, in some regions, in the late fall after harvest. It can be applied aerially or by ground spray. The maximum single application rate for Scepter 70DG is 0.1225 lb/ A. At the time of previous imazaquin assessments, two applications were allowed annually, but as of 2002, labeled use of Scepter 70DG has been limited to one application per year. On turf, imazaquin is applied as ground spray and the maximum single application rate is 0.5 lb/ A. Image labels do not indicate a maximum number of applications per year and indicate that for control of difficult weeds in turf, more than one application may be necessary. The registrant states, however, that only one application of imazaquin is used annually on turf.

Environmental Fate and Transport Characterization Imazaquin is an imidazole compound that is highly mobile ( median K oc = 17.5) and non volatile ( vapor pressure < 2E 8 torr; MRID 146197). In terrestrial environments it is persistent ( aerobic t 1/ 2 = 7 months, anaerobic t 1/ 2 = stable; MRIDs 131564 and 146212). In aquatic environments, imazaquin is stable to hydrolysis at all pH levels ( MRID 131546) and it experiences rapid photolysis ( t 1/ 2 = < 1day; MRID 146209); there are no data available, however, regarding aquatic metabolism. Based on these properties, imazaquin has been identified as a compound likely to be persistent with a high leaching potential. In the one available field dissipation study, imazaquin residues were found through the entire 36 inch depth of the sampling area 3 days after application, following a rain event ( MRID 43019802). Rain or irrigation following application is required to assure the effectiveness of imazaquin, so this rain event does not invalidate the field results ( Reg. Nos. 241 306, 319). The primary degradates resulting from aerobic soil metabolism were carbon dioxide, CL 266,066 ( a closely related decarboxylation product), and up to six other minor, unidentified compounds.

Monitoring Data Existing monitoring data considered in this assessment were the NAWQA groundwater and surface water database ( USGS, 2004) and a study done by the USGS on pesticide contamination in Midwestern groundwater and surface water ( Battaglin et al, 2001).

Surface Water The NAWQA program began in 1991 as an effort by the USGS to catalog the quality of water resources in the United States by collecting surface and groundwater data in selected watersheds. Chemical, biological and physical water quality parameters are measured at 59 study units across the United States. Imazaquin was added as an analyte in 2001. Between 5/ 1/ 01 and 9/ 30/ 03, 943 surface water samples were collected at 70 different locations. There were detections of imazaquin in 158 ( 17%) of these samples, collected at 30 sites. 108 detections at 25 sites were at levels greater than the limit of quantitation ( LOQ) of 0.016 : g/ L. The maximum detection was 4.89 : g/ L and the 95th percentile level was 0.07 : g/ L.

NAWQA's monitoring network is national, and does not target specific pesticides or use patterns. Only 41 of the sites sampled ( 604 samples) are within the area labeled for application of 5 Figure 2. Location and type of USGS sampling sites. imazaquin on soybeans. 6 of the sites with imazaquin detections lie outside of this soybean use region. Additionally, only 4 of the locations with imazaquin detections are in agricultural areas; the other sites are designated as urban ( 13), mixed ( 10), or other ( 3). The highest surface water concentration found was in Durham, Oregon, a suburb of Portland where the primary land uses are residential and parks. This would suggest an impact from the turf use, but none of the grasses to which imazaquin is applied are grown in this region. This site is in the Willamette Basin, however, a major producer of ornamental trees. The 7 sites with the highest maximum values are in urban locations, indicating that the turf and ornamental use patterns may contribute significantly to runoff concentrations.

In 1998, the USGS conducted another study specifically aimed at investigating imidazole and sulfonylurea pesticides ( Battaglin, 2001). This study includes surface water samples from 71 stream locations and 5 reservoir locations in 10 Midwestern states, as shown in Figure 2. Sites were selected to target high agricultural pesticide use areas while still capturing population variability. Two samples were taken at each site; at stream sites, the first sample was taken after preemergent pesticide application and following a precipitation event and the second after post emergent pesticide application, again following a precipitation event. Reservoir samples were taken 2 3 weeks following stream samples. 41 stream samples and 8 reservoir samples had detections above the method reporting limit ( MRL) of 0.010 : g/ L, with a maximum of 1.1 : g/ L, a median of < 0.010 : g/ L, and a 95th percentile value of 0.2 : g/ L. 16 of the sites, including 6 in Indiana, 4 in Ohio, and 3 in Illinois, had detections at both sampling events.

Groundwater The NAWQA program also includes groundwater monitoring. Between 5/ 1/ 01 and 9/ 30/ 03, 1004 samples from 998 sites were tested for imazaquin. There were 18 detections, 7 above the LOQ of 0.016 : g/ L. Detections ranged from 0.019 to 0.098 : g/ L, the maximum from either study. 60% of the measured NAWQA groundwater samples were collected in states listed as use areas on the label for Scepter 70DG. There were, however, detections in Hawaii, New York, and California, states not listed on the Scepter 70DG label or on the labels of discontinued agricultural imazaquin products. As with the surface water, several of the detections were in areas designated urban ( 3) or mixed ( 4). 6 In the USGS 1998 pesticide monitoring program ( Battaglin, 2001), single samples were taken at 25 wells, 20 in Iowa and 5 in northern Illinois, as shown in Figure 2. At the majority of these wells, the depth to the top of the well screen ranged from 6 to 30 m deep while the rest of the wells sampled were as deep as 83 m. As with the surface water monitoring study, these wells were selected in high pesticide use areas, and so are not intended as non targeted samples. Detections at or above the MRL of 0.010 : g/ L were found at 3 of the 25 wells, with levels of 0.010, 0.012, and 0.024 : g/ L.

Exposure Modeling Surface Water To determine Tier II EECs in surface water, the Pesticide Root Zone Model ( PRZM 3.12; 5/ 7/ 98), which simulates transport off the agricultural field, is run in tandem with the Exposure Analysis Modeling System, ( EXAMS 2.98.04; 6/ 13/ 97), which simulates the fate of chemicals in the water body. These are operated using the pe4v01 shell program ( 8/ 13/ 03). Additional information about these models can be found at the EPA's water modeling website, http:// www. epa. gov/ oppefed1/ models/ water/. The simulated watershed is based on an Index Reservoir ( IR) scenario, and a percent cropped area ( PCA) adjustment factor is used to adjust for the area within the watershed that is planted to the modeled crop ( OPP, 2000). Models are run for multiple ( usually 30) years and the reported EECs represent the values that are expected once every ten years, based on the thirty years of daily values generated during the simulation.

The crop scenarios used by PRZM/ EXAMS represent sites that are highly vulnerable to runoff. In this assessment, the Mississippi soybean, Florida turf, and Oregon Christmas tree scenarios were used ( EFED, 2003). The Mississippi soybean scenario is located in Yazoo County, MS, one of the highest use areas depicted in Figure 1. Geographic information about usage of imazaquin on turf is not available, but Florida does lie within the expected imazaquin use region for turf. The Oregon Christmas tree scenario is used as a surrogate for the ornamental use pattern. The scenario is located in Benton County, in the same watershed as the highest surface water detection.

The model input parameter values used, selected in accordance with EFED's input parameter guidance ( EFED, 2002), are presented in Table 2. The application rate used represents the maximum label rate and when multiple possible application methods were available, the one that resulted in the most conservative EEC was chosen. The turf use is simulated with a single annual application, as stated by the registrant, and with multiple applications, as allowed by the label. Half lives are based on registrant submitted data. The PRZM/ EXAMS input files are provided in Appendix A and the output files in Appendix B. Based on modeling results, for soybeans EFED estimates an acute surface water EEC of 1.8 µ g ae/ L and a chronic EEC of 0.4 µ g ae/ L. For turf, at one application per year, the acute surface water EEC is 15.2 µ g ae/ L and the chronic EEC is 5.0 µ g ae/ L, while for two applications, the acute EEC is 20.0 µ g ae/ L and the chronic EEC is 7.6 µ g ae/ L. The acute EEC for ornamentals is 17.4 µ g ae/ L and the chronic EEC is 9.1 µ g ae/ L. 7 Table 2. PRZM/ EXAMS Input Parameters for Imazaquin Drinking Water Assessment Model Parameter Value Comments Source Application Rate per Event Soybeans: 0.14 kg/ ha Turf /: 0.56 kg/ ha Ornamentals Label 241 306 Labels 241 319, 351 Application Dates Soybeans: April 10 Turf / : April 1, Ornamentals ( April 29) 1 app/ yr Unspecified apps/ yr; Typical use = late spring Label 241 319, 351 Spray Drift by Scenario Soybeans: 16 %

Turf /: 6.4 % Ornamentals Soybeans: Aerial Turf : Ground Label 241 306 Labels 241 319, 351 Crop Application Method Soybeans: Soil applied Turf : Foliar Incorporation Depth Soybeans: 0 cm Turf / : 0 cm Ornamentals Aerobic Soil Metabolism Half Life 630 days 3 times single reported value MRID 131564 Anaerobic Soil Metabolism Half Life Stable MRID 146212 Aerobic Aquatic Degradation Half life 1260 days No reported data 2 times Aerobic Soil Metabolism Half life Anaerobic Aquatic Degradation Half life Stable No reported data Assume ½ of anaerobic soil rate or stable Aqueous Photolysis Half life 0.9 day MRID 146209 Hydrolysis Half life Stable MRID 131546 Koc 17.5 ml/ g Median of 4 values MRID 131564 Molecular Weight 311.34 Product Chemistry Water Solubility 6000 mg/ l 10 times reported value Product Chemistry Vapor Pressure < 2 x 10 8 torr Product Chemistry Percent Cropped Area ( PCA) Soybeans: 0.41 Turf / : 1 Ornamentals 8 Groundwater EECs for groundwater were generated with SCIGROW 2.3 ( EFED, 2001b), a screening tool for groundwater used as drinking water. SCIGROW was developed by regressing the results of Prospective Ground Water studies against the Relative Index of Leaching Potential ( RILP). The RILP is a function of aerobic soil metabolism and the soil water partition coefficient. The output of SCIGROW represents the concentrations that might be expected in shallow unconfined aquifers under sandy soils.

As with surface water modeling, model input parameter values used in SCIGROW were selected in accordance with EFED's input parameter guidance ( Environmental Fate and Effects Division, 2002). These input parameters, presented in Table 3, represent the total residues of flazasulfuron at the maximum label application rate. The acute and chronic concentrations of total residues of flazasulfuron in shallow groundwater predicted by SCIGROW under these conditions are 3.8 µ g ae/ L for soybeans, 15.6 µ g ae/ L for a single application on turf or ornamentals, and 31.1 µ g ae/ L for two applications on turf. The SCIGROW input and output files are provided in Appendix C.

Table 3. SCIGROW Input Parameters for Total Residues of Imazaquin Model Parameter Input Value Source Comments Aerobic Soil Metabolism Half Life 210 days MRID 131564 KOC 17.5 mL/ g MRID 131564 Median of 4 values Application Rate Soybeans: 0.12 lb/ A Turf : 0.5 lb/ A Label 241 306 Labels 241 319, 351 Applications Per Year Soybeans: 1 Turf : 1 or 2 Label 241 306 Labels 241 319, 351 Unspecified app / yr Uncertainty The drinking water assessment for imazaquin relied on both an analysis of monitoring data and modeling to predict potential concentrations to which humans may be exposed. There are uncertainties in this assessment for both types of analysis.

Modeling relies on estimated fate parameters and assumed agricultural practices to predict concentrations of imazaquin to which humans may be exposed. In this instance, there were fate data available for all processes except aquatic metabolism. Half life values for aerobic and anaerobic metabolism were estimated based on EFED guidance ( EFED, 2002). This data gap adds some uncertainty to the assessment, but it is limited because soil metabolism is expected to be the primary route of degradation. Only a single study value was available to assess soil metabolism. In order to insure than an EEC is predictive of all populations, this value was 9 multiplied by three to estimate an upper 90th percentile. There were no acceptable data available from terrestrial field dissipation studies to compare with the estimated half lives.

PRZM/ EXAMS requires information on agricultural practices as inputs, such as specific application dates and rates to be applied. In reality, application dates and rates applied across the United States will vary depending on geography, pest pressure, climatic factors, and changes in agricultural cropping patterns. EFED attempts to capture some of this variability by modeling as many representative scenarios as possible and by using meteorological data which covers a time span sufficient to capture climatic variations which are likely to occur. However, the model is limited in its ability to capture all of the natural variation which occurs for any pesticide application and this adds uncertainty to the drinking water assessment. This is of particular importance for the turf scenario, because in this case, the application date of the pesticide is not limited to a specific planting season. It can be applied most of the year, especially in areas like that modeled, where winter dormancy is not expected. Another factor important in estimating runoff and leaching from turf scenarios is the number of applications. The label does not limit the number of applications and specifically states that more than one may be necessary, although the registrant states that typical use is a single application. This assessment shows the estimated concentration increase resulting from a second application, and additional applications would result in further increases.

There is additional uncertainty in the EECs for turf and ornamentals because there is no PCA available for these uses. No adjustment was applied to the turf and ornamental EECs, thereby indicating the assumption that imazaquin is applied to the entire watershed. The choice of scenarios modeled adds further uncertainty to the ornamental EEC. The Oregon Christmas tree scenario is not designed to specifically represent the trees and shrubs on which imazaquin is applied. Because it simulates the soil and crop conditions of a woodland environment, it was selected as the most appropriate scenario available. A PCA of 0.41 is applied to soybeans, based on the maximum cropped percentage in soybean use areas. It does not take into account the fact that applications of imazaquin may be made to soybeans and turf in the same watershed.

EFED has relied on an evaluation of monitoring data for imazaquin collected by others. Each monitoring data set evaluated in this assessment was collected with a different study objective. The NAWQA data represents surface water and groundwater concentrations collected on a national basis with an emphasis on high agricultural use areas. The USGS study is targeted to pesticide use, but imazaquin is one of a large group considered.

Imazaquin has been detected in both surface water and groundwater. However, none of these monitoring data were specifically targeted to imazaquin use. Non targeted monitoring data is typically used by EFED as a check against modeling estimates and not as drinking water estimates for use in the human health dietary assessment. Many of the sample locations included in the reviewed monitoring data sets were not targeted to areas of highest imazaquin use and consequently, extrapolation of concentrations of imazaquin in groundwater and surface water from these data may not be representative of concentrations in all areas of highest imazaquin use. It is important to note that there were a number of detections in locations not expected to be high imazaquin use areas. 10 The frequency of sampling from the monitoring data evaluated also adds uncertainty to this assessment. Estimates from monitoring data of acute exposure have varying sample frequencies and it is unclear what effect this has on peak estimates from monitoring data. Therefore, it is likely that the monitoring data has not captured the maximum peak concentration from the locations sampled. This fact, coupled with the fact that monitoring data are not targeted to imazaquin use areas, adds uncertainty to the estimation of EECs from the monitoring data.

County level use data for imazaquin data have been derived from an approach developed by Thelin and Gianessi, 2000. In this approach Thelin and Gianessi relied on a combination of state level pesticide use data derived from the National Center on Food and Agricultural Policy ( NCFAP) and county level information on harvested crop acreage taken from the USDA Census of Agriculture. This approach is limited by the fact that state level coefficients of pesticide use cannot provide precise county level estimates and do not account for local variations in cropping and management practices. Finally, the approach is limited in that the Census of Agriculture may under report certain crops and regions due to non disclosure. All of these factors add uncertainty to the assessment. 11 Appendix A: PRZM/ EXAMS Input Files 12 Mississippi Soybean MS soybean; 8/ 9/ 01 " Yazoo Co. MLRA 134; Metfile: W13893. dvf ( old: Met134. met)," *** Record 3: 0.75 0.25 0 17 1 3 *** Record 6  ERFLAG 4 *** Record 7: 0.42 0.0151 1 172.8 3 2 600 *** Record 8 1 *** Record 9 1 0.2 30 100 3 87 84 86 0 76 *** Record 9a d 1 27 0101 1601 0102 1602 0103 1603 0104 1604 2004 0105 0505 1605 0106 1606 0107 1607 .245 .276 .306 .337 .373 .418 .468 .498 .575 .627 .654 .620 .484 .361 .220 .094 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 0108 1608 0109 1609 0110 1510 1610 0111 1611 0112 1612 .109 .110 .046 .053 .040 .203 .239 .316 .394 .464 .524 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 .014 *** Record 10  NCPDS, the number of cropping periods 30 *** Record 11 150461 010961 101061 1 150462 010962 101062 1 150463 010963 101063 1 150464 010964 101064 1 150465 010965 101065 1 150466 010966 101066 1 150467 010967 101067 1 150468 010968 101068 1 150469 010969 101069 1 150470 010970 101070 1 150471 010971 101071 1 150472 010972 101072 1 150473 010973 101073 1 150474 010974 101074 1 150475 010975 101075 1 150476 010976 101076 1 150477 010977 101077 1 150478 010978 101078 1 150479 010979 101079 1 150480 010980 101080 1 150481 010981 101081 1 150482 010982 101082 1 150483 010983 101083 1 150484 010984 101084 1 150485 010985 101085 1 150486 010986 101086 1 150487 010987 101087 1 150488 010988 101088 1 13 150489 010989 101089 1 150490 010990 101090 1 *** Record 12  PTITLE imazaquin  1 applications @ .14 kg/ ha *** Record 13 30 1 0 0 *** Record 15  PSTNAM imazaquin *** Record 16 100461 0 1 0.0 0.14 0.84 0.16 100462 0 1 0.0 0.14 0.84 0.16 100463 0 1 0.0 0.14 0.84 0.16 100464 0 1 0.0 0.14 0.84 0.16 100465 0 1 0.0 0.14 0.84 0.16 100466 0 1 0.0 0.14 0.84 0.16 100467 0 1 0.0 0.14 0.84 0.16 100468 0 1 0.0 0.14 0.84 0.16 100469 0 1 0.0 0.14 0.84 0.16 100470 0 1 0.0 0.14 0.84 0.16 100471 0 1 0.0 0.14 0.84 0.16 100472 0 1 0.0 0.14 0.84 0.16 100473 0 1 0.0 0.14 0.84 0.16 100474 0 1 0.0 0.14 0.84 0.16 100475 0 1 0.0 0.14 0.84 0.16 100476 0 1 0.0 0.14 0.84 0.16 100477 0 1 0.0 0.14 0.84 0.16 100478 0 1 0.0 0.14 0.84 0.16 100479 0 1 0.0 0.14 0.84 0.16 100480 0 1 0.0 0.14 0.84 0.16 100481 0 1 0.0 0.14 0.84 0.16 100482 0 1 0.0 0.14 0.84 0.16 100483 0 1 0.0 0.14 0.84 0.16 100484 0 1 0.0 0.14 0.84 0.16 100485 0 1 0.0 0.14 0.84 0.16 100486 0 1 0.0 0.14 0.84 0.16 100487 0 1 0.0 0.14 0.84 0.16 100488 0 1 0.0 0.14 0.84 0.16 100489 0 1 0.0 0.14 0.84 0.16 100490 0 1 0.0 0.14 0.84 0.16 *** Record 17 0 1 0 *** Record 19  STITLE " The Loring, silt loam, HYDG C" *** Record 20 155 0 0 1 0 0 0 0 0 0 *** Record 26 0 0 0 *** Record 30 4 17.5 *** Record 33 6 1 13 1.4 0.385 0 0 0 0.0011 0.0011 0 0.1 0.385 0.151 2.18 0 14 2 23 1.4 0.37 0 0 0 0.0011 0.0011 0 1 0.37 0.146 0.49 0 3 33 1.4 0.37 0 0 0 0.0011 0.0011 0 3 0.37 0.146 0.16 0 4 30 1.45 0.34 0 0 0 0.0011 0.0011 0 5 0.34 0.125 0.124 0 5 23 1.49 0.335 0 0 0 0.0011 0.0011 0 1 0.335 0.137 0.07 0 6 33 1.51 0.343 0 0 0 0.0011 0.0011 0 3 0.343 0.147 0.06 0 *** Record 40 0 YEAR 10 YEAR 10 YEAR 10 1 1 1  7 YEAR PRCP TCUM 0 0 RUNF TCUM 0 0 INFL TCUM 1 1 ESLS TCUM 0 0 1.0E3 RFLX TCUM 0 0 1.0E5 EFLX TCUM 0 0 1.0E5 RZFX TCUM 0 0 1.0E5 15 Florida Turf  Single Application FL Turf 8/ 09/ 2001 Osceola County; Representation of the Lake Kissimmee/ Indian River Region; MLRA 156A; Metfile: W12834. dvf [ Daytona Beach] ( old: Met156A. met) *** Record 3: 0.78 0 0 25 1 3 *** Record 6  ERFLAG 4 *** Record 7: 0.04 0.303 1 172.8 4 2 600 *** Record 8 1 *** Record 9 1 0.1 10 100 3 74 74 74 0 5 *** Record 9a d 1 25 0101 1601 0102 1602 0103 1603 0104 1604 0105 1605 0106 1606 0107 1507 1607 0108 .023 .026 .030 .035 .042 .050 .056 .060 .063 .068 .074 .079 .082 .125 .148 .189 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 1608 0109 1609 0110 1610 0111 1611 0112 1612 .229 .265 .294 .314 .326 .017 .018 .019 .021 .023 .023 .023 .023 .023 .023 .023 .023 .023 *** Record 10  NCPDS, the number of cropping periods 30 *** Record 11 010261 150261 151261 1 010262 150262 151262 1 010263 150263 151263 1 010264 150264 151264 1 010265 150265 151265 1 010266 150266 151266 1 010267 150267 151267 1 010268 150268 151268 1 010269 150269 151269 1 010270 150270 151270 1 010271 150271 151271 1 010272 150272 151272 1 010273 150273 151273 1 010274 150274 151274 1 010275 150275 151275 1 010276 150276 151276 1 010277 150277 151277 1 010278 150278 151278 1 010279 150279 151279 1 010280 150280 151280 1 010281 150281 151281 1 010282 150282 151282 1 010283 150283 151283 1 010284 150284 151284 1 010285 150285 151285 1 010286 150286 151286 1 010287 150287 151287 1 16 010288 150288 151288 1 010289 150289 151289 1 010290 150290 151290 1 *** Record 12  PTITLE imazaquin  1 applications @ .56 kg/ ha *** Record 13 30 1 0 0 *** Record 15  PSTNAM imazaquin *** Record 16 010461 0 2 0.0 0.560.9360.064 010462 0 2 0.0 0.560.9360.064 010463 0 2 0.0 0.560.9360.064 010464 0 2 0.0 0.560.9360.064 010465 0 2 0.0 0.560.9360.064 010466 0 2 0.0 0.560.9360.064 010467 0 2 0.0 0.560.9360.064 010468 0 2 0.0 0.560.9360.064 010469 0 2 0.0 0.560.9360.064 010470 0 2 0.0 0.560.9360.064 010471 0 2 0.0 0.560.9360.064 010472 0 2 0.0 0.560.9360.064 010473 0 2 0.0 0.560.9360.064 010474 0 2 0.0 0.560.9360.064 010475 0 2 0.0 0.560.9360.064 010476 0 2 0.0 0.560.9360.064 010477 0 2 0.0 0.560.9360.064 010478 0 2 0.0 0.560.9360.064 010479 0 2 0.0 0.560.9360.064 010480 0 2 0.0 0.560.9360.064 010481 0 2 0.0 0.560.9360.064 010482 0 2 0.0 0.560.9360.064 010483 0 2 0.0 0.560.9360.064 010484 0 2 0.0 0.560.9360.064 010485 0 2 0.0 0.560.9360.064 010486 0 2 0.0 0.560.9360.064 010487 0 2 0.0 0.560.9360.064 010488 0 2 0.0 0.560.9360.064 010489 0 2 0.0 0.560.9360.064 010490 0 2 0.0 0.560.9360.064 *** Record 17 0 2 0 *** Record 18 0 0 0.5 *** Record 19  STITLE Adamsville Sand; Hydrologic Group C *** Record 20 102 0 0 1 0 0 0 0 0 0 *** Record 26 0 0 0 *** Record 30 4 17.5 *** Record 33 4 17 1 2 0.37 0.47 0 0 0 0.0011 0.0011 0 0.1 0.47 0.27 7.5 0 2 10 1.44 0.086 0 0 0 0.0011 0.0011 0 0.1 0.086 0.036 0.58 0 3 10 1.44 0.086 0 0 0 0.0011 0.0011 0 0.1 0.086 0.036 0.58 0 4 80 1.58 0.03 0 0 0 0.0011 0.0011 0 5 0.03 0.023 0.116 0 *** Record 40 0 YEAR 10 YEAR 10 YEAR 10 1 1 1  7 YEAR PRCP TCUM 0 0 RUNF TCUM 0 0 INFL TCUM 1 1 ESLS TCUM 0 0 1.0E3 RFLX TCUM 0 0 1.0E5 EFLX TCUM 0 0 1.0E5 RZFX TCUM 0 0 1.0E5 18 Florida Turf  Two Applications FL Turf 8/ 09/ 2001 Osceola County; Representation of the Lake Kissimmee/ Indian River Region; MLRA 156A; Metfile: W12834. dvf [ Daytona Beach] ( old: Met156A. met) *** Record 3: 0.78 0 0 25 1 3 *** Record 6  ERFLAG 4 *** Record 7: 0.04 0.303 1 172.8 4 2 600 *** Record 8 1 *** Record 9 1 0.1 10 100 3 74 74 74 0 5 *** Record 9a d 1 25 0101 1601 0102 1602 0103 1603 0104 1604 0105 1605 0106 1606 0107 1507 1607 0108 .023 .026 .030 .035 .042 .050 .056 .060 .063 .068 .074 .079 .082 .125 .148 .189 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 .023 1608 0109 1609 0110 1610 0111 1611 0112 1612 .229 .265 .294 .314 .326 .017 .018 .019 .021 .023 .023 .023 .023 .023 .023 .023 .023 .023 *** Record 10  NCPDS, the number of cropping periods 30 *** Record 11 010261 150261 151261 1 010262 150262 151262 1 010263 150263 151263 1 010264 150264 151264 1 010265 150265 151265 1 010266 150266 151266 1 010267 150267 151267 1 010268 150268 151268 1 010269 150269 151269 1 010270 150270 151270 1 010271 150271 151271 1 010272 150272 151272 1 010273 150273 151273 1 010274 150274 151274 1 010275 150275 151275 1 010276 150276 151276 1 010277 150277 151277 1 010278 150278 151278 1 010279 150279 151279 1 010280 150280 151280 1 010281 150281 151281 1 010282 150282 151282 1 010283 150283 151283 1 010284 150284 151284 1 010285 150285 151285 1 010286 150286 151286 1 010287 150287 151287 1 010288 150288 151288 1 19 010289 150289 151289 1 010290 150290 151290 1 *** Record 12  PTITLE imazaquin  2 applications @ .56 kg/ ha *** Record 13 60 1 0 0 *** Record 15  PSTNAM imazaquin *** Record 16 010461 0 2 0.0 0.560.9360.064 290461 0 2 0.0 0.560.9360.064 010462 0 2 0.0 0.560.9360.064 290462 0 2 0.0 0.560.9360.064 010463 0 2 0.0 0.560.9360.064 290463 0 2 0.0 0.560.9360.064 010464 0 2 0.0 0.560.9360.064 290464 0 2 0.0 0.560.9360.064 010465 0 2 0.0 0.560.9360.064 290465 0 2 0.0 0.560.9360.064 010466 0 2 0.0 0.560.9360.064 290466 0 2 0.0 0.560.9360.064 010467 0 2 0.0 0.560.9360.064 290467 0 2 0.0 0.560.9360.064 010468 0 2 0.0 0.560.9360.064 290468 0 2 0.0 0.560.9360.064 010469 0 2 0.0 0.560.9360.064 290469 0 2 0.0 0.560.9360.064 010470 0 2 0.0 0.560.9360.064 290470 0 2 0.0 0.560.9360.064 010471 0 2 0.0 0.560.9360.064 290471 0 2 0.0 0.560.9360.064 010472 0 2 0.0 0.560.9360.064 290472 0 2 0.0 0.560.9360.064 010473 0 2 0.0 0.560.9360.064 290473 0 2 0.0 0.560.9360.064 010474 0 2 0.0 0.560.9360.064 290474 0 2 0.0 0.560.9360.064 010475 0 2 0.0 0.560.9360.064 290475 0 2 0.0 0.560.9360.064 010476 0 2 0.0 0.560.9360.064 290476 0 2 0.0 0.560.9360.064 010477 0 2 0.0 0.560.9360.064 290477 0 2 0.0 0.560.9360.064 010478 0 2 0.0 0.560.9360.064 290478 0 2 0.0 0.560.9360.064 010479 0 2 0.0 0.560.9360.064 290479 0 2 0.0 0.560.9360.064 010480 0 2 0.0 0.560.9360.064 290480 0 2 0.0 0.560.9360.064 010481 0 2 0.0 0.560.9360.064 290481 0 2 0.0 0.560.9360.064 010482 0 2 0.0 0.560.9360.064 290482 0 2 0.0 0.560.9360.064 010483 0 2 0.0 0.560.9360.064 20 290483 0 2 0.0 0.560.9360.064 010484 0 2 0.0 0.560.9360.064 290484 0 2 0.0 0.560.9360.064 010485 0 2 0.0 0.560.9360.064 290485 0 2 0.0 0.560.9360.064 010486 0 2 0.0 0.560.9360.064 290486 0 2 0.0 0.560.9360.064 010487 0 2 0.0 0.560.9360.064 290487 0 2 0.0 0.560.9360.064 010488 0 2 0.0 0.560.9360.064 290488 0 2 0.0 0.560.9360.064 010489 0 2 0.0 0.560.9360.064 290489 0 2 0.0 0.560.9360.064 010490 0 2 0.0 0.560.9360.064 290490 0 2 0.0 0.560.9360.064 *** Record 17 0 2 0 *** Record 18 0 0 0.5 *** Record 19  STITLE Adamsville Sand; Hydrologic Group C *** Record 20 102 0 0 1 0 0 0 0 0 0 *** Record 26 0 0 0 *** Record 30 4 17.5 *** Record 33 4 1 2 0.37 0.47 0 0 0 0.0011 0.0011 0 0.1 0.47 0.27 7.5 0 2 10 1.44 0.086 0 0 0 0.0011 0.0011 0 0.1 0.086 0.036 0.58 0 3 10 1.44 0.086 0 0 0 0.0011 0.0011 0 0.1 0.086 0.036 0.58 0 4 80 1.58 0.03 0 0 0 0.0011 0.0011 0 5 0.03 0.023 0.116 0 *** Record 40 0 YEAR 10 YEAR 10 YEAR 10 1 1 1  7 YEAR PRCP TCUM 0 0 RUNF TCUM 0 0 INFL TCUM 1 1 ESLS TCUM 0 0 1.0E3 RFLX TCUM 0 0 1.0E5 EFLX TCUM 0 0 1.0E5 RZFX TCUM 0 0 1.0E5 21 Oregon Ornamentals ORXmastree; 11/ 8/ 2001 " Benton Co. OR MLRA A2; Metfile: W24232. dvf ( old: Met2. met)," *** Record 3: 0.73 0.16 0 17 1 2 *** Record 6  ERFLAG 4 *** Record 7: 0.37 0.69 1 172.8 2 4 600 *** Record 8 1 *** Record 9 1 0.25 120 40 2 80 72 77 0 250 *** Record 9a d 1 24 0101 1601 0102 1602 0103 1603 0104 1604 0105 1605 0106 1606 0107 1607 0108 1608 .009 .010 .015 .016 .023 .029 .034 .038 .041 .039 .038 .034 .029 .024 .021 .021 .040 .040 .040 .040 .040 .040 .040 .040 .040 .040 .040 .040 .040 .040 .040 .040 0109 1609 0110 1610 0111 1611 0112 1612 .023 .024 .027 .029 .006 .007 .007 .008 .040 .040 .040 .040 .040 .040 .040 .040 *** Record 10  NCPDS, the number of cropping periods 30 *** Record 11 150461 150861 301061 1 150462 150862 301062 1 150463 150863 301063 1 150464 150864 301064 1 150465 150865 301065 1 150466 150866 301066 1 150467 150867 301067 1 150468 150868 301068 1 150469 150869 301069 1 150470 150870 301070 1 150471 150871 301071 1 150472 150872 301072 1 150473 150873 301073 1 150474 150874 301074 1 150475 150875 301075 1 150476 150876 301076 1 150477 150877 301077 1 150478 150878 301078 1 150479 150879 301079 1 150480 150880 301080 1 150481 150881 301081 1 150482 150882 301082 1 150483 150883 301083 1 150484 150884 301084 1 150485 150885 301085 1 150486 150886 301086 1 150487 150887 301087 1 150488 150888 301088 1 22 150489 150889 301089 1 150490 150890 301090 1 *** Record 12  PTITLE imazaquin  1 applications @ .56 kg/ ha *** Record 13 30 1 0 0 *** Record 15  PSTNAM imazaquin *** Record 16 010461 0 2 0.0 0.560.936 0.64 010462 0 2 0.0 0.560.936 0.64 010463 0 2 0.0 0.560.936 0.64 010464 0 2 0.0 0.560.936 0.64 010465 0 2 0.0 0.560.936 0.64 010466 0 2 0.0 0.560.936 0.64 010467 0 2 0.0 0.560.936 0.64 010468 0 2 0.0 0.560.936 0.64 010469 0 2 0.0 0.560.936 0.64 010470 0 2 0.0 0.560.936 0.64 010471 0 2 0.0 0.560.936 0.64 010472 0 2 0.0 0.560.936 0.64 010473 0 2 0.0 0.560.936 0.64 010474 0 2 0.0 0.560.936 0.64 010475 0 2 0.0 0.560.936 0.64 010476 0 2 0.0 0.560.936 0.64 010477 0 2 0.0 0.560.936 0.64 010478 0 2 0.0 0.560.936 0.64 010479 0 2 0.0 0.560.936 0.64 010480 0 2 0.0 0.560.936 0.64 010481 0 2 0.0 0.560.936 0.64 010482 0 2 0.0 0.560.936 0.64 010483 0 2 0.0 0.560.936 0.64 010484 0 2 0.0 0.560.936 0.64 010485 0 2 0.0 0.560.936 0.64 010486 0 2 0.0 0.560.936 0.64 010487 0 2 0.0 0.560.936 0.64 010488 0 2 0.0 0.560.936 0.64 010489 0 2 0.0 0.560.936 0.64 010490 0 2 0.0 0.560.936 0.64 *** Record 17 0 2 0 *** Record 18 0 0 0.5 *** Record 19  STITLE Pilchuck *** Record 20 150 0 0 1 0 0 0 0 0 0 *** Record 26 0 0 0 *** Record 30 4 17.5 *** Record 33 4 1 10 1.55 0.123 0 0 0 23 0.0011 0.0011 0 0.1 0.123 0.033 1.16 0 2 40 1.7 0.123 0 0 0 0.0011 0.0011 0 2 0.123 0.033 1.16 0 3 50 1.8 0.069 0 0 0 0.0011 0.0011 0 5 0.069 0.019 0.174 0 4 50 1.8 0.046 0 0 0 0.0011 0.0011 0 5 0.046 0.016 0.116 0 *** Record 40 0 YEAR 10 YEAR 10 YEAR 10 1 1 1  7 YEAR PRCP TCUM 0 0 RUNF TCUM 0 0 INFL TCUM 1 1 ESLS TCUM 0 0 1.0E3 RFLX TCUM 0 0 1.0E5 EFLX TCUM 0 0 1.0E5 RZFX TCUM 0 0 1.0E5 24 Appendix B: PRZM/ EXAMS Output Files 25 Mississippi Soybeans stored as soy84. out Chemical: imazaquin PRZM environme nt: MSsoybea nC. txt modified Satday, 12 October 2002 at 17: 07: 44 EXAMS environme nt: ir298. exv modified Thuday, 29 August 2002 at 15: 34: 12 Metfile: w13893. d vf modified Wedday, 3 July 2002 at 09: 06: 20 Water segment concentrations ( ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly 1961 2.959 2.882 2.617 2.11 1.791 0.6197 1962 1.016 0.9887 0.8799 0.7664 0.6705 0.2533 1963 0.939 0.9175 0.85 0.7437 0.6413 0.2298 1964 1.296 1.262 1.149 0.9193 0.7794 0.2717 1965 0.8302 0.8079 0.7217 0.5702 0.4833 0.172 1966 0.951 0.9337 0.8432 0.731 0.6283 0.2226 1967 0.9797 0.9549 0.8895 0.7317 0.6224 0.2209 1968 1.188 1.157 1.04 0.8389 0.7131 0.2499 1969 3.631 3.534 3.294 2.605 2.198 0.7607 1970 1.662 1.618 1.474 1.173 1.012 0.3721 1971 1.344 1.308 1.17 0.9477 0.8271 0.3016 1972 1.145 1.114 1.017 0.8501 0.7498 0.2744 1973 1.158 1.128 1.02 0.8396 0.7191 0.2565 1974 2.934 2.856 2.604 2.084 1.766 0.615 1975 0.8475 0.8252 0.7559 0.6261 0.533 0.1995 1976 0.852 0.8293 0.7953 0.6786 0.5814 0.205 1977 1.517 1.477 1.318 1.068 0.9276 0.3311 1978 1.217 1.184 1.076 0.8706 0.7378 0.2606 1979 10.69 10.41 9.416 7.486 6.33 2.176 1980 6.199 6.034 5.486 4.345 3.668 1.293 1981 1.055 1.027 0.92 0.789 0.6808 0.2669 1982 2.818 2.779 2.531 2.006 1.696 0.5974 1983 4.52 4.404 3.996 3.173 2.684 0.9344 1984 0.9588 0.936 0.8503 0.7522 0.6519 0.2509 1985 4.125 4.014 3.594 2.827 2.383 0.8411 1986 0.8945 0.8749 0.8219 0.6789 0.5786 0.2221 1987 2.491 2.424 2.163 1.698 1.434 0.4989 1988 1.439 1.4 1.274 1.035 0.8773 0.3116 1989 0.8318 0.8097 0.7245 0.5724 0.4851 0.1741 1990 1.43 1.405 1.303 1.05 0.9054 0.3188 Sorted results Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly 26 0.032258 10.69 10.41 9.416 7.486 6.33 2.176 0.064516 6.199 6.034 5.486 4.345 3.668 1.293 0.096774 4.52 4.404 3.996 3.173 2.684 0.9344 0.129032 4.125 4.014 3.594 2.827 2.383 0.8411 0.16129 3.631 3.534 3.294 2.605 2.198 0.7607 0.193548 2.959 2.882 2.617 2.11 1.791 0.6197 0.225806 2.934 2.856 2.604 2.084 1.766 0.615 0.258065 2.818 2.779 2.531 2.006 1.696 0.5974 0.290323 2.491 2.424 2.163 1.698 1.434 0.4989 0.322581 1.662 1.618 1.474 1.173 1.012 0.3721 0.354839 1.517 1.477 1.318 1.068 0.9276 0.3311 0.387097 1.439 1.405 1.303 1.05 0.9054 0.3188 0.419355 1.43 1.4 1.274 1.035 0.8773 0.3116 0.451613 1.344 1.308 1.17 0.9477 0.8271 0.3016 0.483871 1.296 1.262 1.149 0.9193 0.7794 0.2744 0.516129 1.217 1.184 1.076 0.8706 0.7498 0.2717 0.548387 1.188 1.157 1.04 0.8501 0.7378 0.2669 0.580645 1.158 1.128 1.02 0.8396 0.7191 0.2606 0.612903 1.145 1.114 1.017 0.8389 0.7131 0.2565 0.645161 1.055 1.027 0.92 0.789 0.6808 0.2533 0.677419 1.016 0.9887 0.8895 0.7664 0.6705 0.2509 0.709677 0.9797 0.9549 0.8799 0.7522 0.6519 0.2499 0.741935 0.9588 0.936 0.8503 0.7437 0.6413 0.2298 0.774194 0.951 0.9337 0.85 0.7317 0.6283 0.2226 0.806452 0.939 0.9175 0.8432 0.731 0.6224 0.2221 0.83871 0.8945 0.8749 0.8219 0.6789 0.5814 0.2209 0.870968 0.852 0.8293 0.7953 0.6786 0.5786 0.205 0.903226 0.8475 0.8252 0.7559 0.6261 0.533 0.1995 0.935484 0.8318 0.8097 0.7245 0.5724 0.4851 0.1741 0.967742 0.8302 0.8079 0.7217 0.5702 0.4833 0.172 0.1 4.4805 4.365 3.9558 3.1384 2.6539 0.92507 Average of yearly averages: 0.45672 Inputs generated by pe4. pl  8 August 2003 27 Florida Turf  Single Application stored as tf1apr1. out Chemical: imazaquin PRZM environme nt: FLturfC. txt modified Monday, 16 June 2003 at 14: 48: 06 EXAMS environme nt: ir298. exv modified Thuday, 29 August 2002 at 15: 34: 12 Metfile: w12834. d vf modified Wedday, 3 July 2002 at 09: 04: 28 Water segment concentrations ( ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly 1961 1.308 1.286 1.242 1.132 1.047 0.4784 1962 1.681 1.661 1.567 1.37 1.242 0.7496 1963 1.906 1.888 1.781 1.601 1.521 0.8549 1964 10.07 9.923 9.393 8.169 7.372 3.328 1965 3.136 3.097 2.995 2.635 2.389 1.603 1966 10.95 10.78 10.12 8.935 8.149 3.811 1967 4.556 4.492 4.253 3.735 3.388 1.978 1968 1.854 1.826 1.716 1.523 1.534 0.9614 1969 3.281 3.233 3.1 2.738 2.484 1.276 1970 3.964 3.906 3.672 3.218 2.936 1.45 1971 9.209 9.07 8.51 7.433 6.736 3.108 1972 2.021 1.991 1.871 1.705 1.608 0.9969 1973 3.809 3.751 3.569 3.117 2.82 1.324 1974 1.596 1.571 1.472 1.279 1.189 0.6491 1975 5.13 5.052 4.768 4.151 3.755 1.727 1976 21.53 21.2 19.85 17.29 15.66 7.042 1977 3.104 3.063 2.897 2.556 2.462 1.792 1978 13.4 13.19 12.33 10.66 9.622 4.327 1979 2.379 2.344 2.202 2.087 1.923 1.241 1980 3.515 3.474 3.268 2.915 2.665 1.255 1981 2.83 2.786 2.607 2.271 2.076 1.143 1982 20.18 19.89 18.7 16.25 14.66 6.534 1983 6.844 6.739 6.408 5.58 5.041 2.785 1984 15.37 15.16 14.23 12.36 11.15 5.055 1985 4.021 3.961 3.719 3.227 2.93 1.711 1986 1.623 1.596 1.491 1.286 1.159 0.6214 1987 1.728 1.702 1.596 1.387 1.346 0.6908 1988 1.47 1.447 1.357 1.253 1.162 0.5844 1989 2.861 2.815 2.647 2.288 2.058 1.009 1990 1.547 1.523 1.426 1.235 1.114 0.5709 Sorted results Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly 0.032258 21.53 21.2 19.85 17.29 15.66 7.042 28 0.064516 20.18 19.89 18.7 16.25 14.66 6.534 0.096774 15.37 15.16 14.23 12.36 11.15 5.055 0.129032 13.4 13.19 12.33 10.66 9.622 4.327 0.16129 10.95 10.78 10.12 8.935 8.149 3.811 0.193548 10.07 9.923 9.393 8.169 7.372 3.328 0.225806 9.209 9.07 8.51 7.433 6.736 3.108 0.258065 6.844 6.739 6.408 5.58 5.041 2.785 0.290323 5.13 5.052 4.768 4.151 3.755 1.978 0.322581 4.556 4.492 4.253 3.735 3.388 1.792 0.354839 4.021 3.961 3.719 3.227 2.936 1.727 0.387097 3.964 3.906 3.672 3.218 2.93 1.711 0.419355 3.809 3.751 3.569 3.117 2.82 1.603 0.451613 3.515 3.474 3.268 2.915 2.665 1.45 0.483871 3.281 3.233 3.1 2.738 2.484 1.324 0.516129 3.136 3.097 2.995 2.635 2.462 1.276 0.548387 3.104 3.063 2.897 2.556 2.389 1.255 0.580645 2.861 2.815 2.647 2.288 2.076 1.241 0.612903 2.83 2.786 2.607 2.271 2.058 1.143 0.645161 2.379 2.344 2.202 2.087 1.923 1.009 0.677419 2.021 1.991 1.871 1.705 1.608 0.9969 0.709677 1.906 1.888 1.781 1.601 1.534 0.9614 0.741935 1.854 1.826 1.716 1.523 1.521 0.8549 0.774194 1.728 1.702 1.596 1.387 1.346 0.7496 0.806452 1.681 1.661 1.567 1.37 1.242 0.6908 0.83871 1.623 1.596 1.491 1.286 1.189 0.6491 0.870968 1.596 1.571 1.472 1.279 1.162 0.6214 0.903226 1.547 1.523 1.426 1.253 1.159 0.5844 0.935484 1.47 1.447 1.357 1.235 1.114 0.5709 0.967742 1.308 1.286 1.242 1.132 1.047 0.4784 0.1 15.173 14.963 14.04 12.19 10.9972 4.9822 Average of yearly averages: 2.021893 Inputs generated by pe4. pl  8 August 2003 29 Florida Turf  Two Applications stored as tf2apr1. out Chemical: imazaquin PRZM environme nt: FLturfC. txt modified Monday, 16 June 2003 at 14: 48: 06 EXAMS environme nt: ir298. exv modified Thuday, 29 August 2002 at 15: 34: 12 Metfile: w12834. d vf modified Wedday, 3 July 2002 at 09: 04: 28 Water segment concentrations ( ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly 1961 3.181 3.134 2.941 2.607 2.409 1.15 1962 4.554 4.501 4.247 3.712 3.365 1.827 1963 5.682 5.623 5.312 4.64 4.336 2.303 1964 14.97 14.74 13.83 12.12 11.01 5.097 1965 9.097 8.992 8.664 7.632 6.919 3.777 1966 14.16 13.96 13.17 11.73 11.33 5.886 1967 9.091 8.963 8.483 7.448 6.756 3.715 1968 3.772 3.733 3.586 3.239 3.119 1.969 1969 6.881 6.779 6.502 5.741 5.207 2.592 1970 4.969 4.893 4.592 4.429 4.269 2.353 1971 10.71 10.54 9.884 9.053 8.788 4.429 1972 3.647 3.596 3.39 3.133 2.897 1.819 1973 4.695 4.624 4.34 3.955 3.729 1.88 1974 2.702 2.661 2.501 2.302 2.137 1.207 1975 5.936 5.847 5.491 5.053 4.677 2.243 1976 21.65 21.32 19.96 19.07 17.69 8.207 1977 5.405 5.333 5.024 4.365 4.104 2.798 1978 13.8 13.58 13.16 12.32 11.82 5.746 1979 6.519 6.427 6.032 5.243 4.768 2.812 1980 7.208 7.098 6.7 5.854 5.341 2.8 1981 6.138 6.043 5.654 4.929 4.511 2.429 1982 20.54 20.24 19.03 17.63 16.46 7.754 1983 15.09 14.91 14.09 12.28 11.07 6.147 1984 22.18 21.84 20.49 17.8 16.45 9.088 1985 5.813 5.726 5.366 4.931 4.564 2.926 1986 2.771 2.727 2.554 2.217 2.027 1.169 1987 3.838 3.779 3.542 3.078 2.826 1.419 1988 2.989 2.955 2.78 2.47 2.254 1.205 1989 7.922 7.795 7.324 6.33 5.694 2.603 1990 2.892 2.848 2.67 2.32 2.137 1.255 Sorted results Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly 0.032258 22.18 21.84 20.49 19.07 17.69 9.088 30 0.064516 21.65 21.32 19.96 17.8 16.46 8.207 0.096774 20.54 20.24 19.03 17.63 16.45 7.754 0.129032 15.09 14.91 14.09 12.32 11.82 6.147 0.16129 14.97 14.74 13.83 12.28 11.33 5.886 0.193548 14.16 13.96 13.17 12.12 11.07 5.746 0.225806 13.8 13.58 13.16 11.73 11.01 5.097 0.258065 10.71 10.54 9.884 9.053 8.788 4.429 0.290323 9.097 8.992 8.664 7.632 6.919 3.777 0.322581 9.091 8.963 8.483 7.448 6.756 3.715 0.354839 7.922 7.795 7.324 6.33 5.694 2.926 0.387097 7.208 7.098 6.7 5.854 5.341 2.812 0.419355 6.881 6.779 6.502 5.741 5.207 2.8 0.451613 6.519 6.427 6.032 5.243 4.768 2.798 0.483871 6.138 6.043 5.654 5.053 4.677 2.603 0.516129 5.936 5.847 5.491 4.931 4.564 2.592 0.548387 5.813 5.726 5.366 4.929 4.511 2.429 0.580645 5.682 5.623 5.312 4.64 4.336 2.353 0.612903 5.405 5.333 5.024 4.429 4.269 2.303 0.645161 4.969 4.893 4.592 4.365 4.104 2.243 0.677419 4.695 4.624 4.34 3.955 3.729 1.969 0.709677 4.554 4.501 4.247 3.712 3.365 1.88 0.741935 3.838 3.779 3.586 3.239 3.119 1.827 0.774194 3.772 3.733 3.542 3.133 2.897 1.819 0.806452 3.647 3.596 3.39 3.078 2.826 1.419 0.83871 3.181 3.134 2.941 2.607 2.409 1.255 0.870968 2.989 2.955 2.78 2.47 2.254 1.207 0.903226 2.892 2.848 2.67 2.32 2.137 1.205 0.935484 2.771 2.727 2.554 2.302 2.137 1.169 0.967742 2.702 2.661 2.501 2.217 2.027 1.15 0.1 19.995 19.707 18.536 17.099 15.987 7.5933 Average of yearly averages: 3.3535 31 Oregon Christmas Tree stored as ORxmas. out Chemical: imazaquin PRZM environme nt: ORXmasT reeC. txt modified Satday, 12 October 2002 at 17: 23: 10 EXAMS environme nt: ir298. exv modified Thuday, 29 August 2002 at 15: 34: 12 Metfile: w24232. d vf modified Wedday, 3 July 2002 at 09: 06: 10 Water segment concentrations ( ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly 1961 13.08 12.94 12.51 11.61 10.96 5.817 1962 16.16 16.03 15.5 14.4 13.62 8.21 1963 17.02 16.89 16.46 15.32 14.47 8.999 1964 17.33 17.19 16.62 15.41 14.56 9.113 1965 17.32 17.18 16.63 15.43 14.54 9.005 1966 17.28 17.13 16.53 15.25 14.35 8.88 1967 17.23 17.09 16.53 15.3 14.41 8.796 1968 17.02 16.89 16.31 15.11 14.26 8.828 1969 17.3 17.16 16.62 15.4 14.52 9.035 1970 17.25 17.12 16.57 15.36 14.47 8.913 1971 17.41 17.28 16.98 15.9 15.06 9.317 1972 17.51 17.37 16.82 15.59 14.68 9.079 1973 17.24 17.1 16.51 15.24 14.36 8.892 1974 17.25 17.12 16.58 15.41 14.55 8.96 1975 17.19 17.05 16.49 15.27 14.39 8.901 1976 17.16 17.03 16.47 15.25 14.38 8.887 1977 17.07 16.93 16.34 15.14 14.29 8.836 1978 17.28 17.15 16.61 15.42 14.55 9.036 1979 17.52 17.38 16.83 15.61 14.69 9.094 1980 17.23 17.09 16.66 15.46 14.63 9.037 1981 17.22 17.09 16.55 15.38 14.54 9.001 1982 17.22 17.08 16.49 15.23 14.33 8.88 1983 17.22 17.07 16.48 15.22 14.35 8.955 1984 17.27 17.14 16.61 15.44 14.59 9.024 1985 17.2 17.06 16.48 15.26 14.39 8.841 1986 17.05 16.91 16.35 15.17 14.3 8.807 1987 17.12 16.98 16.39 15.14 14.24 8.717 1988 16.98 16.85 16.31 15.16 14.32 8.761 1989 17.17 17.03 16.44 15.21 14.34 8.883 1990 17.21 17.07 16.5 15.31 14.49 9.008 Sorted results Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly 32 0.032258 17.52 17.38 16.98 15.9 15.06 9.317 0.064516 17.51 17.37 16.83 15.61 14.69 9.113 0.096774 17.41 17.28 16.82 15.59 14.68 9.094 0.129032 17.33 17.19 16.66 15.46 14.63 9.079 0.16129 17.32 17.18 16.63 15.44 14.59 9.037 0.193548 17.3 17.16 16.62 15.43 14.56 9.036 0.225806 17.28 17.15 16.62 15.42 14.55 9.035 0.258065 17.28 17.14 16.61 15.41 14.55 9.024 0.290323 17.27 17.13 16.61 15.41 14.54 9.008 0.322581 17.25 17.12 16.58 15.4 14.54 9.005 0.354839 17.25 17.12 16.57 15.38 14.52 9.001 0.387097 17.24 17.1 16.55 15.36 14.49 8.999 0.419355 17.23 17.09 16.53 15.32 14.47 8.96 0.451613 17.23 17.09 16.53 15.31 14.47 8.955 0.483871 17.22 17.09 16.51 15.3 14.41 8.913 0.516129 17.22 17.08 16.5 15.27 14.39 8.901 0.548387 17.22 17.07 16.49 15.26 14.39 8.892 0.580645 17.21 17.07 16.49 15.25 14.38 8.887 0.612903 17.2 17.06 16.48 15.25 14.36 8.883 0.645161 17.19 17.05 16.48 15.24 14.35 8.88 0.677419 17.17 17.03 16.47 15.23 14.35 8.88 0.709677 17.16 17.03 16.46 15.22 14.34 8.841 0.741935 17.12 16.98 16.44 15.21 14.33 8.836 0.774194 17.07 16.93 16.39 15.17 14.32 8.828 0.806452 17.05 16.91 16.35 15.16 14.3 8.807 0.83871 17.02 16.89 16.34 15.14 14.29 8.796 0.870968 17.02 16.89 16.31 15.14 14.26 8.761 0.903226 16.98 16.85 16.31 15.11 14.24 8.717 0.935484 16.16 16.03 15.5 14.4 13.62 8.21 0.967742 13.08 12.94 12.51 11.61 10.96 5.817 0.1 17.402 17.271 16.804 15.577 14.675 9.0925 Average of yearly averages: 8.817067 Inputs generated by pe4. pl  8 August 2003 33 Appendix C: SCIGROW Input/ Output Modeling File SCIGROW VERSION 2.3 ENVIRONMENTAL FATE AND EFFECTS DIVISION OFFICE OF PESTICIDE PROGRAMS U. S. ENVIRONMENTAL PROTECTION AGENCY SCREENING MODEL FOR AQUATIC PESTICIDE EXPOSURE SOYBEANS SciGrow version 2.3 chemical: Imazaquin time is 6/ 8/ 2005 16: 58: 31  Application Number of Total Use Koc Soil Aerobic rate ( lb/ acre) applications ( lb/ acre/ yr) ( ml/ g) metabolism ( days)  0.123 1.0 0.123 1.75E+ 01 210.0  groundwater screening cond ( ppb) = 3.83E+ 00 ************************************************************************

TURF / ORNAMENTALS SciGrow version 2.3 chemical: Imazaquin time is 6/ 8/ 2005 16: 58: 17  Application Number of Total Use Koc Soil Aerobic rate ( lb/ acre) applications ( lb/ acre/ yr) ( ml/ g) metabolism ( days)  0.500 1.0 0.500 1.75E+ 01 210.0  groundwater screening cond ( ppb) = 1.56E+ 01 ************************************************************************

SciGrow version 2.3 chemical: Imazaquin time is 6/ 8/ 2005 16: 58: 23  Application Number of Total Use Koc Soil Aerobic rate ( lb/ acre) applications ( lb/ acre/ yr) ( ml/ g) metabolism ( days)  0.500 2.0 1.000 1.75E+ 01 210.0  groundwater screening cond ( ppb) = 3.11E+ 01 ************************************************************************ 34 References Battaglin, W. A., E. T. Furlong, and M. R. Burkhardt. 2001. Concentration of Selected Sulfonylurea, Sulfonamide, and Imidazolinone Herbicides, Other Pesticides, and Nutrients in 71 Streams, 5 Reservoir Outflows, and 25 Wells in the Midwestern United States, 1998. U. S. Geological Survey Water Resources Investigations Report 00 4225. Denver, CO. http:// co. water. usgs. gov/ midconherb/ pdf/ wrir00 4225. pdf Biological and Economic Analysis Division. 2005. Screening Level Use Report for Imazaquin. O'Neill, J. 1/ 28/ 05.

Environmental Fate and Effects Division. 2001b. SCI GROW  ( S) creening ( C) oncentration ( I) n ( GRO) und ( W) ater: User's Manual. Office of Pesticide Programs, U. S. Environmental Protection Agency, Washington, D. C. http:// www. epa. gov/ oppefed1/ models/ water/ scigrow_ users_ manual. htm Environmental Fate and Effects Division. 2002. Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides, Version II. Office of Pesticide Programs, U. S. Environmental Protection Agency. Washington, D. C. http:// www. epa. gov/ oppefed1/ models/ water/ input_ guidance2_ 28_ 02. htm Environmental Fate and Effects Division. 2003. Pesticide Root Zone Model Field and Orchard Crop Scenario Metadata. May 23, 2003. Office of Pesticide Programs, U. S. Environmental Protection Agency, Washington, D. C. http:// www. epa. gov/ oppefed1/ models/ water/ przm_ scenario_ metadata. wpd Office of Pesticide Programs. 2000. Drinking Water Screening Level Asssessments. September 1, 2000. Office of Pesticide Programs, U. S. Environmental Protection Agency, Washington, D. C http:// www. epa. gov/ oppfead1/ trac/ science/ reservoir. pdf Thielen, G. P. and L. P. Gianessi. 2000. Method for Estimating Pesticide Use for County Areas of the Coterminous United States. USGS Open File Report 00 250. Sacramento, CA. http:// ca. water. usgs. gov/ pnsp/ rep/ ofr00250/ ofr00250. pdf U. S. Department of Agriculture. 1997. Usual Planting and Harvesting Dates for U. S. Field Crops. Agricultural Handbook No. 628. National Agricultural Statistics Survey, U. S. Department of Agriculture, Washington, D. C. http:// usda. mannlib. cornell. edu/ reports/ nassr/ field/ planting/ uph97. html U. S. Geological Survey. 2003. 1997 Pesticide Use Maps. NAWQA Pesticide National Synthesis Project. September 3, 2003. http:// ca. water. usgs. gov/ pnsp/ pesticide_ use_ maps_ 1997/

U. S. Geological Survey. 2004. NAWQA National Water Quality Assessment Data Warehouse. http:// infotrek. er. usgs. gov/ servlet/ page?_ pageid= 543&_ dad= portal30&_ schema= PORTAL30


[Federal Register Volume 78, Number 160 (Monday, August 19, 2013)]
[Notices]
[Pages 50410-50411]
[FR Doc No: 2013-20033]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13102-003--Alabama; Demopolis Lock and Dam Hydroelectric
Project]

Birch Power Company; Notice of Proposed Restricted Service List
for a Programmatic Agreement

    Rule 2010 of the Federal Energy Regulatory Commission's
(Commission) Rules of Practice and Procedure, 18 CFR section 385.2010,
provides that, to eliminate unnecessary expense or improve
administrative efficiency, the Secretary may establish a restricted
service list for a particular phase or issue in a proceeding. The
restricted service list should contain the names of persons on the
service list who, in the judgment of the decisional authority
establishing the list, are active participants with respect to the
phase or issue in the proceeding for which the list is established.
    The Commission staff is consulting with the Alabama Historical
Commission (Alabama SHPO) and the Advisory Council on Historic
Preservation (Advisory Council) pursuant to the Advisory Council's
regulations, 36 CFR part 800, implementing section 106 of the National
Historic Preservation Act, as amended, (16 U.S.C. 470f), to prepare a
Programmatic Agreement for managing properties included in, or eligible
for inclusion in, the National Register of Historic Places that could
be affected by issuance of a license for the Demopolis Lock and Dam
Hydroelectric Project.
    The Programmatic Agreement, when executed by the Commission and the
Alabama SHPO, would satisfy the Commission's section 106
responsibilities for all individual undertakings carried out in
accordance with the license until the license expires or is terminated
(36 CFR section 800.13[e]). The Commission's responsibilities pursuant
to section 106 for the project would be fulfilled through the
Programmatic Agreement, which the Commission staff proposes to draft in
consultation with certain parties listed below.
    Birch Power Company, as applicant for the proposed Demopolis
Hydroelectric Project, the U.S. Army Corps of Engineers, the Poarch
Band of Creek Indians, Alabama-Coushatta Tribe of Texas, Alabama-
Quassarte Tribal Town, United Keetoowah Band of Cherokee Indians,
Choctaw Nation of Oklahoma, Jena Band of Choctaw Indians, Muscogee
(Creek) Nation, and

Kialegee Tribal Town of the Muscogee (Creek) Nation have expressed an
interest in this proceeding and are invited to participate in
consultations to develop the Programmatic Agreement and to sign as a
concurring party to the Programmatic Agreement. For purposes of
commenting on the Programmatic Agreement, we propose to restrict the
service list for Project No. 13102-003 as follows:

John Eddins, Advisory Council on Historic Preservation, The Old Post
Office Building, 1100 Pennsylvania Avenue, NW., Suite 803, Washington,
DC 20004
Greg Rhinehart, Alabama Historical Commission, 468 South Perry Street,
Montgomery, AL 36130-0900
Joseph Giliberti, U.S. Army Corps of Engineers, Mobile District, 109
Saint Joseph Street, MS-PDEI, Mobile, AL 36628-0001
Nicholas E. Josten, Agent, Birch Power Company, 2742 Saint Charles
Avenue, Idaho Falls, ID 83404
Robert Thrower, THPO, Poarch Band of Creek Indians, 5811 Jack Springs
Road, Atmore, AL 36502
Bryant Celestine, THPO, Alabama-Coushatta Tribe of Texas, 571 State
Park Road 56, Livingston, TX 77351
Augustine Asbury, Alabama-Quassarte Tribal Town, P.O. Box 187, Wetumka,
OK 74883
Lisa Baker, THPO, United Keetoowah Band of Cherokee Indians, 20525 S.
Jules Valdez Road, Tahlequah, OK 74464
Dr. Ian Thompson, THPO, Choctaw Nation of Oklahoma, P.O. Box 1210,
Durant, OK 74701
Johnnie Jacobs, Choctaw Nation of Oklahoma, P.O. Box 1210, Durant, OK
74701
Dana Masters, THPO, Jena Band of Choctaw Indians, P.O. Box 14, Jena, LA
71342
Emman Spain, THPO, Muscogee (Creek) Nation, P.O. Box 580, Okmulgee, OK
74447
Chief George Tiger or Representative, Kialegee Tribal Town of the
Muscogee (Creek) Nation, P.O. Box 146, Wetumpka, OK 74883

    Any person on the official service list for the above-captioned
proceedings may request inclusion on the restricted service list, or
may request that a restricted service list not be established, by
filing a motion to that effect within 15 days of this notice date. An
original plus five copies of any such motion must be filed with the
Secretary of the Commission (888 First Street NE., Washington, DC
20426) and must be served on each person whose name appears on the
official service list. If no such motions are filed, the restricted
service list will be effective at the end of the 15 day period.
Otherwise, a further notice will be issued ruling on the motion.

    Dated: August 12, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-20033 Filed 8-16-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14420-14421]
[FR Doc No: 2021-05382]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 15054-000]

Kinet, Inc.; Notice of Preliminary Permit Application Accepted
for Filing and Soliciting Comments, Motions To Intervene, and Competing
Applications

    On November 6, 2020, Kinet, Inc., filed an application for a
preliminary permit, pursuant to section 4(f) of the Federal Power Act
(FPA), proposing to study the feasibility of a conventional hydropower
project located in Jessamine, Garrard, and Madison Counties, Kentucky.
The sole purpose of a preliminary permit, if issued, is to grant the
permit holder priority to file a license application during the permit
term. A preliminary permit does not authorize the permit holder to
perform any land-disturbing activities or otherwise enter upon lands or
waters owned by others without the owners' express permission.
    The proposed Kentucky River Lock and Dam No. 8 Hydroelectric
Project would consist of the following: (1) An existing 309-foot-long,
31-foot-high, timber crib dam with concrete overlay connected to a 384-
foot-long, and 52-foot-wide abandoned navigation lock, which are owned
by the Kentucky River Authority; (2) a reservoir with a surface area of
499 acres and a storage capacity of 8,700 acre-feet; (3) six, proposed,
32-foot-long, 9-foot-diameter penstocks connected to six generating
units with a combined capacity of 3.7 megawatts, within the existing
lock; (4) a proposed powerhouse/control room adjacent to the lock; (5)
a 30-foot-long by 75-foot-wide tailrace; and (6) a 675-foot-long, 12.47
kilo-Volt transmission line. The proposed project would have an
estimated annual generation of 21,002 megawatt-hours.
    Applicant Contact: Jessica Penrod, Natel Energy, Inc., 2401 Monarch
Street, Alameda, CA 9401; phone:<PHONE_NUMBER>.
    FERC Contact: Joshua Dub; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at https://ferconline.ferc.gov/FERCOnline.aspx. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at https://ferconline.ferc.gov/QuickComment.aspx. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, you may submit a paper copy.
Submissions sent via the U.S. Postal Service must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Room 1A, Washington, DC 20426. Submissions sent via
any other carrier must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville,
Maryland 20852.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's website at

https://elibrary.ferc.gov/eLibrary/search. Enter the docket number (P-
15054) in the docket number field to access the document. For
assistance, contact FERC Online Support.

    Dated: March 10, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-05382 Filed 3-15-21; 8:45 am]
BILLING CODE 6717-01-P


                          MCPB, sodium salt (019202)
                     Screening Level Usage Analysis (SLUA)
                            Date: February 15, 2013

What is a Screening Level Usage Analysis (SLUA)?
 Available estimates of pesticide usage data for a particular active ingredient that is used on agricultural crops in the United States.
 Pesticide usage data obtained from various sources.  The data are then merged, averaged, and rounded so that the presented information is not proprietary, business confidential, or trade secret.
What does it contain?
 Pesticide usage data for a single active ingredient only.
 Agricultural use sites (crops) that the pesticide is reported to be used on.
 Available pesticide usage information from U.S. states that produce 80% or more of a crop, in most cases, or less than 80%, in rare cases, depending on the scope of the survey and available resources.
 Annual percent of crop treated (average & maximum) for each agricultural crop.
 Average annual pounds of the pesticide applied for each agricultural crop (i.e., for the states surveyed, not for the entire United States).
What assumptions can I make about the reported data?
 Average pounds of active ingredient applied - Values are calculated by merging pesticide usage data sources together; averaging across all observations, then rounding.  Note:  If the estimated value is less than 500, then that value is labeled <500.  Estimated values between 500 & <1,000,000 are rounded to 1 significant digit.  Estimated values of 1,000,000 or greater are rounded to 2 significant digits.)
 Average percent of crop treated - Values are calculated by merging data sources together; averaging by year, averaging across all years, & rounding to the nearest multiple of 5.  Note:  If the estimated value is less than 2.5, then the value is labeled <2.5.  If the estimated value is less than 1, then the value is labeled <1.
 Maximum percent of crop treated - Value is the single maximum value reported across all data sources, across all years, & rounded up to the nearest multiple of 5.  Note:  If the estimated value is less than 2.5, then the value is labeled <2.5.
What are the data sources used?
 USDA-NASS (United States Department of Agriculture's National Agricultural Statistics Service)  -  pesticide usage data from 2004 to 2011.
 Private pesticide market research  -  pesticide usage data from 2004 to 2011.
 California Department of Pesticide Regulation (DPR) Pesticide Use Reporting (PUR) data for 2004 to 2010.
What are the limitations to the data?
 Additional registered uses may exist but are not included because the available surveys do not report usage (e.g., small acreage crops).
 Lack of reported usage data for the pesticide on a crop does not imply zero usage.
 Usage data on a particular site may be noted in data sources, but not quantified.  In these instances, the site would not be reported in the SLUA.
 Non-agricultural use sites (e.g., turf, post-harvest, mosquito control, etc.) are not reported in the SLUA.  A separate request must be made to receive these estimates.
 Some sites show some use, even though they are not on the label.  This usage could be due to various factors, including, but not limited to Section 18 requests, existing stocks of the chemical, data collection errors, and experimental use permits (EUPs).

                              February 15, 2013

 Screening Level Estimates of Agricultural Uses of MCPB, sodium salt (019202)
                             Sorted Alphabetically
                       (Reporting Timeframe: 2004-2011)

                             Percent Crop Treated
                                     Crop
                                   Lbs. A.I.
                                    Average
                                    Maximum
1
Dry Beans/Peas*
                                     4,000
                                     <1
                                    <2.5
2
Peas, Green
                                    10,000
                                      15
                                      20
All numbers rounded.

                                                                        <2.5
Less than 2.5 percent of crop treated
                                                                          <1
Less than 1 percent of crop treated

      * Survey data lists dry beans/peas together, but the registration and tolerance exists for peas only.

SLUA data sources include:
  USDA-NASS (United States Department of Agriculture's National Agricultural Statistics Service)
Private Pesticide Market Research

These results reflect amalgamated data developed by the Agency and are releasable to the public.


[Federal Register: April 4, 2008 (Volume 73, Number 66)]
[Notices]
[Page 18587-18589]
[DOCID:fr04ap08-116]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57579; File No. SR-NASDAQ-2008-026]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
to Participate in the Options Penny Pilot Program

March 28, 2008.
    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 March 25, 2008, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been substantially prepared by Nasdaq. The
Exchange filed the proposal as a ``non-controversial'' proposed rule
change pursuant to section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6) thereunder,\4\ which rendered the proposal effective upon
filing with the Commission. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    Nasdaq is planning to commence trading on its recently-approved
NASDAQ Options Market \5\ on March 31, 2008, and to participate from
that date in the Options Penny Pilot Program by trading in penny
increments all 63 options currently scheduled to be traded in penny
increments on the six existing options exchanges.\6\ Nasdaq's
participation in the pilot will commence at the start of trading on the
NASDAQ Options Market on March 31, 2008, and continue until March 27,
2009.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 57478 (March 12,
2008), 73 FR 14521 (March 18, 2008) (SR-NASDAQ-2007-004 and SR-
NASDAQ-2007-080).
    \6\ The following options will be traded on The NASDAQ Options
Market beginning March 31, 2008: QQQQ and AMAT. See Options Trader
Alert 2008-4 at http://www.nasdaqtrader.com/
TraderNews.aspx?id=OTA2008-004.
---------------------------------------------------------------------------

    The text of the proposed rule change is available at Nasdaq, the
Commission's Public Reference Room, and http://www.nasdaq.com.

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

    In its filing with the Commission, Nasdaq 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. Nasdaq 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
    On March 12, 2008, the Commission approved SR-NASDAQ-2007-004 and
SR-NASDAQ-2007-080, proposals to create the NASDAQ Options Market
(``NOM''). Chapter VI, Section 5 of the approved rules states that
Nasdaq may trade options in penny increments pursuant to the
Commission's pilot program for options (``Penny Pilot Program'').
Through this filing, Nasdaq proposes to establish the parameters of its
participation in the Penny Pilot Program.
    Prior to the Penny Pilot Program, options were quoted in nickel and
dime increments. The minimum price variation for quotations in options
series that are quoted at less than $3 per contract is $0.05 and the
minimum price variation for quotations in options series that are
quoted at $3 per contract or greater is $0.10.
    Under the Penny Pilot Program, beginning on January 26, 2007,
market participants were able to begin quoting in penny increments in
certain series of option classes. The Penny Pilot Program originally
included the following thirteen options: Ishares Russell 2000 (IWM);
NASDAQ-100 Index Tracking Stock (QQQQ); SemiConductor Holders Trust
(SMH); General Electric Company (GE); Advanced Micro Devices, Inc.
(AMD); Microsoft Corporation (MSFT); Intel Corporation (INTC);
Caterpillar, Inc. (CAT); Whole Foods Market, Inc. (WFMI); Texas
Instruments, Inc. (TXN); Flextronics International Ltd. (FLEX); Sun
Microsystems, Inc. (JAVA); and Agilent Technologies, Inc. (A).
    On September 28, 2007, the following twenty-two options classes
were added: SPDRs (SPY); Apple, Inc. (AAPL); Altria Group Inc. (MO);
Dendreon Corp. (DNDN); Amgen Inc. (AMGN); Yahoo! Inc. (YHOO); QUALCOMM
Inc. (QCOM); General Motors Corporation (GM); Energy Select Sector
(XLE); DIAMONDS Trust, Series 1 (DIA); Oil Services HOLDRs (OIH); NYSE
Euronext, Inc. (NYX); Cisco Systems, Inc. (CSCO); Financial Select
Sector SPDR (XLF); AT&T Inc. (T); Citigroup Inc. (C); Amazon.com Inc.
(AMZN); Motorola Inc. (MOT); Research in Motion Ltd. (RIMM); Freeport-
McMoRan Copper & Gold Inc. (FCX); ConocoPhillips (COP); and Bristol-
Myers Squibb Co. (BMY). These thirty-five options classes are among the
most actively-traded, multiply-listed options classes.

    The next phase of the Penny Pilot Program is scheduled to commence
on March 28, 2008, with the addition of the following 28 options
classes: Goldman Sachs Group, Inc. (GS); Countrywide Financial
Corporation (CFC); Bank of America Corporation (BAC); iShares MSCI
Emerging Mkts. Index Fund (EEM); Merrill Lynch & Co., Inc. (MER); Vale
(RIO); EMC Corporation (EMC); Exxon Mobil Corporation (XOM); Wal-Mart
Stores, Inc. (WMT); The Home Depot, Inc. (HD); Valero Energy
Corporation (VLO); Alcoa Inc. (AA); Dell Inc. (DELL); SanDisk
Corporation (SNDK); The Bear Stearns Companies, Inc. (BSC); Pfizer Inc.
(PFE); eBay Inc. (EBAY); Halliburton Company (HAL); Lehman Brothers
Holdings Inc. (LEH); JPMorgan Chase & Co. (JPM); Washington Mutual,
Inc. (WM); Ford Motor Company (F); Target Corporation (TGT); American
International Group, Inc. (AIG); Newmont Mining Corporation (NEM);
Verizon Communications Inc. (VZ); Mini-NDX Index Options (MNX); and
Starbucks Corporation (SBUX).
    The minimum price variation for all classes included in the Penny
Pilot Program, except for the QQQQs, will be $0.01 for all quotations
in option series that are quoted at less than $3 per contract and $0.05
for all quotations in option series that are quoted at $3 per contract
or greater. The QQQQs will be quoted in $0.01 increments for all
options series.
    During the extended and expanded Pilot Program, Nasdaq commits to
deliver two reports to the Commission. Each report will analyze the
impact of penny pricing on market quality and options system capacity.
The first report will analyze the results from March 31, 2008 through
July 31, 2008, and the second report will examine the results from
August 1, 2008 through January 31, 2009. These reports will be provided
to the Commission within thirty days of the conclusion of the reporting
period.
2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\7\ in general, and with Section
6(b)(5) of the Act,\8\ in particular, in that it is designed to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest; and are not designed to
permit unfair discrimination between customers, issuers, brokers, or
dealers, or to regulate by virtue of any authority conferred by this
title matters not related to the purposes of this title or the
administration of the exchange.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f.
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Analysis of the current Penny Pilot Program has shown that the
reduction in the minimum quoting increment has resulted in narrowing
the average quoted spreads in all classes in the Pilot. A reduction in
quoted spreads means that customers and other market participants may
be able to trade options at better prices. Nasdaq's participation in
the Penny Pilot Program as proposed by Nasdaq will allow further
analysis of the impact of penny quoting in the Pilot classes over a
longer period of time on, among other things: (1) Spreads; (2) peak
quote rates; (3) quote message traffic; (4) displayed size; (5) ``depth
of book'' liquidity; and (6) market structure. Nasdaq's unique options
market structure will add to the analysis delivered by the existing
options markets to date.

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

    Nasdaq 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

    The proposed rule change has become effective pursuant to section
19(b)(3)(A) of the Act \9\ and Rule 19b-4(f)(6) thereunder,\10\ because
the foregoing proposed rule does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally may
not become operative prior to 30 days after the date of filing.\11\
However, Rule 19b-4(f)(6)(iii) permits the Commission to designate a
shorter time if such action is consistent with the protection of
investors and the public interest.\12\ Nasdaq has requested that the
Commission waive the 30-day operative delay. Nasdaq has represented
that it has carefully planned a detailed and thorough testing and roll-
out schedule for the NOM market, and has coordinated that schedule with
numerous industry participants. Waiving the 30-day operative delay will
allow Nasdaq to participate in the ongoing industry-wide Penny Pilot
Program upon commencement of trading on the Nasdaq Options Market on
March 31, 2008. Furthermore, the proposed rule change is substantially
similar to the Pilot programs of the other six options exchanges, which
were approved by the Commission after notice and comment, and does not
present any novel regulatory issues.\13\ For these reasons, the
Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest,
and designates the proposal to be operative upon filing with the
Commission.\14\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires the self-regulatory organization to give the
Commission notice of its intent to file the proposed rule change,
along with a brief description and text of the proposed rule change,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. Nasdaq has satisfied the five-day pre-filing
requirement.
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ See, e.g., Securities Exchange Act Release No. 56568
(September 27, 2007), 72 FR 56422 (October 3, 2007) (SR-NYSEArca-
2007-88).
    \14\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.\15\
---------------------------------------------------------------------------

    \15\ See 15 U.S.C. 78s(b)(3)(C).
---------------------------------------------------------------------------

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-NASDAQ-2008-026 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2008-026. 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 inspection
and copying 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 the filing also will be available for
inspection and copying at the principal office of Nasdaq. 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 available publicly. All
submissions should refer to File Number SR-NASDAQ-2008-026 and should
be submitted on or before April 25, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-6960 Filed 4-3-08; 8:45 am]

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[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Notices]
[Pages 27137-27138]
[FR Doc No: 2019-12320]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-E-0047]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ALUNBRIG

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for ALUNBRIG and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by August
12, 2019. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by December 9, 2019.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 12, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-E-0047 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; ALUNBRIG.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper

submission. You should submit two copies total. One copy will include
the information you claim to be confidential with a heading or cover
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.''
The Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with Sec.
10.20 (21 CFR 10.20) and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, ALUNBRIG
(brigatinib) indicated for treatment of patients with anaplastic
lymphoma kinase-positive metastatic non-small cell lung cancer who have
progressed on or are intolerant to crizotinib. This indication is
approved under accelerated approval based on tumor response rate and
duration of response. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in a
confirmatory trial. Subsequent to this approval, the USPTO received a
patent term restoration application for ALUNBRIG (U.S. Patent No.
9,012,462) from ARIAD Pharmaceutials, Inc. and the USPTO requested
FDA's assistance in determining the patent's eligibility for patent
term restoration. In a letter dated February 2, 2018, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of ALUNBRIG represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ALUNBRIG is 2,105 days. Of this time, 1,862 days occurred during the
testing phase of the regulatory review period, while 243 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
July 26, 2011. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was July 26,
2011.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: August 29,
2016. FDA has verified the applicant's claim that the new drug
application (NDA) for ALUNBRIG (NDA 208772) was initially submitted on
August 29, 2016.
    3. The date the application was approved: April 28, 2017. FDA has
verified the applicant's claim that NDA 208772 was approved on April
28, 2017.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 81 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12320 Filed 6-10-19; 8:45 am]
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