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

EPA Registration Division contact: [Shaja Joyner, PM 20<PHONE_NUMBER>]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.

TEMPLATE:

[FMC Corporation]

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from [FMC Corporation], [1735 Market St., Philadelphia, PA 19103] requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180

(Options (pick one)        	1. by establishing a tolerance for residues of

	[valifenalate (Methyl N-(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)- β  - alaninate)] in or on the raw agricultural commodity potato at 0.01; fruiting vegetable crop group 8-10 at 0.50; tomato-wet peel at 0.9; bulb vegetable crop group 3-07 at 0.40; cucurbit crop group 9 at 0.30; celery at 5.0; and grape import tolerance at 5.0 parts per million (ppm).  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. Valifenalate metabolism in plants was studied in grapes, potato, tomato and lettuce covering fruits, root and tuber vegetables and leafy crop groups. Valifenalate was not extensively metabolized in the crop matrices (RACs) analyzed. Majority of the parent compound remained unchanged with formation of a few minor non-significant metabolites. In addition, there was no change in the ratio of isomers (S,R/S,S).

	A confined rotational crop (CRC) study with Valifenalate in leafy crop (lettuce), root crop (carrot) and cereal crop (wheat) was conducted at an exaggerated application rate of 1.4 kg a.i./ha. The total radioactive residue (TRR) in the crops was less than 0.03 mg/kg in all RACs of human consumption, and valifenalate was found at low levels only in carrot leaves and wheat straw matrices. Valifenalate metabolic pathway in rotational crops was similar to that of primary crops.  	 	2. Analytical method. There is a practical analytical method for detecting and measuring levels of valifenalate and its metabolite in or on crop matrices and processed commodities.  The analytical method has a limit of quantitation that allows monitoring of food with residues at or above the levels set in the tolerances.  The analytical enforcement method for valifenalate was used with minor modifications to match the analytical laboratory equipment parameters and to optimize chromatography.  The analytical method for valifenalate involves sequential solvent extractions followed by dilution and analysis by LC/MS/MS.  Valifenalate and the metabolite valifenalate acid are separated by the same analytical method and quantitated using matrix matched standards.

	3. Magnitude of residues. Field residue trials were conducted on potatoes.  Three (3) applications of valifenalate formulated as a WG were applied at a nominal rate of 150 g/ha.  The test substance was applied at 5 day intervals with the last application 7 days prior to potato harvest.  Twenty six (26) field residue trials were performed on potatoes in NAFTA regions 1, 2, 3, 5, 7, 9, 10, 11, and 14.  Residues in harvested potatoes ranged from below the limit of detection (ND) to 0.009 ppm.  An exaggerated rate (5X) trial was conducted to determine residues in processed commodities wet peel, peeled potatoes, dried pulp, granules/flakes, and chips.  Valifenalate residues were less than the LOQ in all processed commodities.

Field residue trials were conducted on grapes.  Fifteen trials were conducted in the United States and Canada.  Three (3) applications of valifenalate formulated as a WG were applied at a nominal rate of 150 g/ha.  The test substance was applied at 10 day intervals with the last application 14 days prior to fruit harvest.  Fifteen (15) field residue trials were performed on grapes in NAFTA regions 1, 5, 10, and 11.  Residues in harvested grapes ranged from 0.031  -  1.77 ppm.  Six trials were previously conducted in Argentina in 2008 and 2011.  Three to four (3-4) applications of valifenalate formulated as a WG were applied at a nominal rate of 180 g/ha.  The test substance was applied at 7-14 day intervals with the last application 21 days prior to fruit harvest.  Valifenalate residues in harvested grapes ranged from 0.64  -  2.92 ppm.  Fourteen trials were previously conducted in Europe (France, Italy, and Germany) from 2003  -  2005.  Three applications of valifenalate formulated as a WG were applied at a nominal rate of 120 g/ha.  The test substance was applied at a 12-14 day interval with the last application 28 days prior to fruit harvest.  Valifenalate residues in harvested grapes ranged from <0.010  -  0.121 ppm.

Field residue trials were conducted on the representative crops of the bulb vegetable crop group 3-07 (green onion and bulb onion).  Three (3) applications of valifenalate formulated as a WG were applied at a nominal rate of 150 g/ha.  The test substance was applied at 7 day intervals with the last application 7 days prior to onion harvest.  Five (5) field residue trials were performed on green onions in NAFTA regions 5, 6, and 10.    Valifenalate residues in harvested green onions ranged from 0.038  -  0.340 ppm.  Nine (9) field residue trials were performed on bulb onions in NAFTA regions 1, 5, 6, 8, 10, and 11.  Valifenalate residues in harvested bulb onions ranged from 0.011  -  0.117 ppm.

Field residue trials were conducted on celery.  Three (3) applications of valifenalate formulated as a WG were applied at a nominal rate of 150 g/ha.  The test substance was applied at 7 day intervals with the last application 1 day prior to vegetable harvest. Ten (10) field residue trials were performed on celery in NAFTA regions 3, 5, and 10.  Valifenalate residues in harvested celery ranged from 0.054  -  3.47 ppm.

Field residue trials were conducted on the representative crops of the fruiting vegetable crop group 8-10 (tomatoes, bell peppers, non-bell peppers).  Three (3) applications of valifenalate formulated as a WG were applied at a nominal rate of 150 g/ha.  The test substance was applied at 7 day intervals with the last application 1 day prior to vegetable harvest.  Nineteen (19) field residue trials were performed on tomatoes in NAFTA regions 1, 2, 3, 5, and 10.  Valifenalate residues in harvested tomatoes ranged from ND  -  0.161 ppm.    An exaggerated rate (5X) trial was conducted to determine residues in processed commodities paste, puree, washed tomatoes, and wet peel.  Valifenalate residues concentrated 5.8X in wet peel.  Valifenalate did not concentrate significantly in the other tomato processed commodities.  Ten (10) field trials were performed on bell peppers in NAFTA regions 2, 3, 5, 6, and 10.  Valifenalate residues in harvested bell peppers ranged from 0.0089  -  0.300 ppm.  Three (3) field trials were performed on non-bell peppers in NAFTA regions 8, 9, and 10.  Valifenalate residues in harvested non-bell peppers ranged from <LOQ  -  0.470 ppm.

Field residue trials were conducted on the representative crops of the cucurbit vegetable crop group 9 (cucumbers, muskmelon, summer squash).  Three (3) applications of valifenalate formulated as a WG were applied at a nominal rate of 150 g/ha.  The test substance was applied at 7 day intervals with the last application 1 day prior to vegetable harvest.  Nine (9) field residue trials were performed on cucumbers in NAFTA regions 2, 3, 5, and 6.  Valifenalate residues in harvested cucumbers ranged from 0.010  -  0.090 ppm.  Ten (10) field residue trials were performed on muskmelon in NAFTA regions 2, 5, 6, and 10.  Valifenalate residues in harvested muskmelon ranged from 0.018  -  0.193 ppm.  Nine (9) field residue trials were performed on summer squash in NAFTA regions 1, 2, 3, 5, and 10.  Valifenalate residues in harvested summer squash ranged from ND  -  0.126 ppm.

B. Toxicological Profile

	1. Acute toxicity.  Valifenalate demonstrates low oral, dermal and inhalation toxicity.  The acute oral LD50 value in the rat was greater than 5000 mg/kg, the acute dermal LD50 value in the rat was greater than 2000 mg/kg and the acute inhalation LC50 value in the rat was greater than 3.118 mg/L/4h.  Valifenalate is non-irritating to rabbit skin and to rabbit eyes.  It did not cause skin sensitization in guinea pigs.  An acute neurotoxicity study in the rat had a NOAEL for neurotoxicity greater than 2000 mg/kg (highest dose tested) based on the lack of neurotoxic clinical signs or effects on neuropathology.

	2. Genotoxicty. Valifenalate did not cause mutations in the Ames assay with or without metabolic activation.  The Chromosome Aberration and Mouse Lymphoma (forward gene mutation) Assays were negative with and without S9 activation.  The Mouse Micronucleus assay in bone marrow cells (an in vivo test which also measures chromosome damage), was negative.

	3. Reproductive and developmental toxicity. Valifenalate is not considered to be a reproductive or a developmental toxicant.  In the 2-generation reproduction study, the NOAEL for parental, reproductive, and developmental toxicity was greater than 1250/850 ppm (greater than 80-100 mg/kg/day).  In the developmental toxicity studies, the rat and rabbit maternal and fetal NOAELs were greater than 1000 mg/kg/day (highest dose tested).

	4. Subchronic toxicity. Ninety-day feeding studies were conducted in mice, rats and dogs with valifenalate.  The NOAEL for the mouse study was 110 ppm (15.3 mg/kg/day) based on decreased body weight gain; for the rat study the NOAEL was 150 mg/kg/day based on distended caecum, and adaptive changes in liver and kidney; and for the dog study the NOAEL was < 50 mg/kg/day (no NOAEL could be established) based on liver and thyroid alterations.  A 90-day subchronic neurotoxicity study was not conducted in the rat.

	5. Chronic toxicity. A 2-Year Combined Chronic Toxicity/Oncogenicity study in the rat was negative for carcinogenicity and had a chronic toxicity NOAEL of 150 mg/kg/day in males and females based on slight anemia in males and pelvic epitheliar hyperplasia in females. There is no carcinogenic potential in rat.  An 18 Month Oncogenicity study in the mouse had a NOAEL greater than 150 ppm (>16.8 mg/kg/day for males; >21.6 mg/kg/day for females) based on increased incidence of hepatocellular tumors evident in both males and females. Additional mode of action studies support rodent specific tumors. The increased incidence of hepatocellular tumors was secondary to adaptive metabolic changes. Such findings are observed commonly in mice and are generally considered of no significance for man.  A 1-Year Oral Toxicity study in the dog had a NOEL of 7 mg/kg/day based on changes in clinical chemistry, and liver and thyroid alterations.

Using the Guidelines for Carcinogen Risk Assessment, valifenalate should be classified as "not likely to be carcinogenic".

	6. Animal metabolism. In rat ADME studies, valifenalate absorption was about 80%. Excretion was rapid (>99%, within 48 hrs) and it was mainly via bile. There was no evidence for accumulation in tissues. Liver and kidneys had higher concentrations of radioactivity compared to rest of the tissues. Valifenalate was extensively metabolized (> 90%) through ester hydrolysis, hydroxylation and side-chain cleavage. Valifenalate acid and 3-amino-3-(4-chlorophenyl)propionic acid) were the main metabolites.

In a metabolism study with lactating goat, valifenalate reached plateau concentrations within 8 hrs in milk. The concentrations of radioactivity in milk were low. Valifenalate excreted primarily via feces (~ 68%). Liver and kidneys were found to have the highest residues with very low concentrations in muscle. The compound was not fat soluble. Metabolism in rat and live-stock was similar.

	7. Metabolite toxicology. Two relevant metabolites have been identified: IR5839 (valifenalate acid) and PCBA. For IR5839, the acute oral LD - 50 > 2000 mg/kg bw and had no genotoxic potential (3 in vitro and 1 in vivo studies). For PCBA, the acute oral LD - 50 > 1170 mg/kg bw and had no genotoxic potential (3 in vitro and 1 in vivo studies).

	8. Endocrine disruption. An evaluation of the potential effects on the endocrine systems of mammals has not been determined; however, no evidence of such effects was reported in the subchronic, chronic or reproductive toxicology studies described above.  There was no observed pathology of the endocrine organs in these studies.  There is no evidence at this time that valifenalate causes an endocrine effect.

C. Aggregate Exposure

	1. Dietary exposure. Acute and chronic dietary exposure assessments were performed for valifenalate using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID(TM), Version 4.02), which incorporates food consumption data from the National Health and Nutrition Examination Survey)/"What We Eat in America" (NHANES/WWEIA) dietary survey for the years 2005-2010. The residues of concern for risk assessment in plant commodities are parent valifenalate and valifenalate acid. The residues of concern for risk assessment in drinking water are parent valifenalate, valifenalate acid and PCBA (p-Chlorobenzoic acid). The acute and chronic analyses were based on tolerance-level residues and 100% crop treated assumptions for all commodities. Default DEEM processing factors were used for all processed commodities. Drinking water estimates were incorporated directly into the acute and chronic dietary exposure assessments using the highest estimated drinking water concentrations (EDWCs) from surface and ground water.

	i. Food. The acute dietary (food only) risk assessment for valifenalate was performed for all population subgroups using an acute reference dose (aRfD) of 10 mg/kg/day based upon a developmental toxicity study in rats with a no observed adverse effect level (NOAEL) of 1000 mg/kg/day and an uncertainty factor of 100X to account for intra- and inter-species variations. No additional FQPA safety factor was applied. The acute population adjusted dose (aPAD) is equivalent to the aRfD of 10 mg/kg/day. At the 95[th] percentile, the acute (food only) exposure for total U.S. population was estimated to be 0.15% of the aPAD. The population subgroup with the highest acute dietary (food only) exposure was children 1-2 years old, estimated to be 0.67% of the aPAD. Since the EPA generally has no concern for exposures < 100% of the aPAD, there is reasonable certainty that no harm will result from acute dietary (food only) exposure to residues arising from all proposed uses of valifenalate.

The chronic dietary (food only) risk assessment for valifenalate was performed for all population subgroups using a chronic reference dose (cRfD) of 0.07 mg/kg/day based upon a 1-year oral toxicity study in dogs with a no observed adverse effect level (NOAEL) of 7 mg/kg/day and an uncertainty factor of 100X to account for intra- and inter-species variations. No additional FQPA safety factor was applied. The chronic population adjusted dose (cPAD) is equivalent to the cRfD of 0.07 mg/kg/day. The chronic (food only) exposure for total US population was estimated to be 5.3% of the cPAD. The population subgroup with the highest acute dietary (food only) exposure was children 1-2 years old, estimated to be 22.4% of the cPAD. Since the EPA generally has no concern for exposures < 100% of the cPAD, there is a reasonable certainty that no harm will result from chronic dietary (food only) exposure to residues arising from all proposed uses of valifenalate.

	ii. Drinking water. The estimated drinking water concentrations (EDWCs) of valifenalate and its degradates valifenalate acid and PCBA, reported as combined total residues of valifenalate, were determined for currently proposed uses. The Tier I FQPA Index Reservoir Screening Tool (FIRST) was used to estimate surface water EDWCs, and the Tier 1 Pesticide Root Zone Model for Ground Water (PRZM-GW) was used to estimate ground water EDWCs. For surface water, the proposed use on potatoes (3 applications x 0.133 lb ai/A with 5-day spray interval) provided a combined acute EDWC of 30.489 ppb and a combined chronic EDWC of 7.246 ppb. For ground water, the maximum proposed use rate of 0.4 lb ai/A/season (3 applications x 0.133 lb ai/A) was used for the six standard EFED vulnerable groundwater scenarios in PRZM-GW. The highest ground water EDWCs were estimated to be 6.96 ppb (acute) and 2.04 ppb (chronic). Since the surface water EDWCs exceeded the ground water EDWCs, surface water EDWCs were used for risk assessment purposes and considered protective for ground water exposure concerns. The acute EDWC (30.489 ppb) and chronic EDWC (7.246 ppb) in surface water were incorporated directly into this dietary assessment in the DEEM-FCID into the food categories "water, direct, all sources" and "water, indirect, all sources".

	2. Non-dietary exposure. There is no residential use proposed for valifenalate. Therefore, a non-dietary exposure assessment was not performed.

D. Cumulative Effects

	The EPA is also required to consider the potential for cumulative effects of valifenalate and other substances that have a common mechanism of toxicity.  The EPA consideration of a common mechanism of toxicity is not appropriate at this time since the EPA does not have information to indicate that toxic effects produced by valifenalate would be cumulative with those of any other chemical compounds; thus only the potential risks of valifenalate are considered in this exposure assessment.

E. Safety Determination

	1. U.S. population. The acute aggregate dietary exposure (food and drinking water) was estimated to be 0.16% of the aPAD for total U.S. population. The chronic aggregate dietary exposure (food and drinking water) was estimated to be 5.5% of the cPAD for total U.S. population. The EPA generally has no concern for exposures below 100% of the aPAD or cPAD.  Therefore, based on the completeness and reliability of the toxicity data and the conservative exposure assessment, there is a reasonable certainty that no harm will result from aggregate dietary exposure to residues of valifenalate from food and water.

	2. Infants and children. The acute aggregate dietary exposure (food and drinking water) was estimated to be 0.67% of the aPAD for children 1-2 years old, the most sensitive population subgroup. The chronic aggregate dietary exposure (food and drinking water) was estimated to be 22.7% of the cPAD for the most sensitive population subgroup of children 1-2 years old. The EPA generally has no concern for exposures below 100% of the aPAD or cPAD.  Therefore, based on the completeness and reliability of the toxicity data and the conservative exposure assessment, there is a reasonable certainty that no harm will result to infants and children from aggregate dietary exposure to residues of valifenalate from food and water.

F. International Tolerances  No Codex MRLs have been established for valifenalate.  European Union MRLs have been set on grapes, tomatoes and eggplant.  No Canadian MRLs exist at this time.


                                                                PC Code: 099100
                                                 DP Barcodes:  D403871, D405066
              OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460
 --------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------
MEMORANDUM

DATE:	April 04, 2013

SUBJECT:	Addendum of Drinking Water Exposure Assessment for the Section 3 New Use of Pyraclostrobin on Various Agricultural Crops and Residential Ornamentals

TO:		Andrew Ertman, Risk Manager Reviewer
		Barbara Madden, Product Manager
      Registration Division (7505P)

FROM:	Faruque Khan, Ph.D. Senior Fate Scientist
		Environmental Risk Branch I
		Environmental Fate and Effects Division (7507P)

APPROVED
BY:		Edward Odenkirchen, Ph.D, Acting Branch Chief
		Sujatha Sankula, Ph.D. Lead Biologist
		Environmental Risk Branch I
		Environmental Fate and Effects Division (7507P)

Executive Summary

This is an addendum to the earlier memorandum related to drinking water exposure assessment issued on February 13, 2013. This revised memorandum reflects recently withdrawn cranberry use by the registrant. In addition, exposure of pyraclostrobin in ground water was evaluated with the PRZM-GW model as well as recent published pyraclostrobin monitoring data were summarized in this memorandum. The estimated drinking water concentrations (EDWCs) of pyraclostrobin ( carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl[oxy]methyl]phenyl methoxy-,methyl ester]) in surface water and ground water in support of the proposed Section 3 new use of pyraclostrobin for control of a variety of fungi on several use sites were summarized below.

 The Interregional Research Project Number 4 is seeking registration of several new uses (described in Table 1)  of pyraclostrobin on one supplemental label for Cabrio[(R)] Fungicide and one supplemental label Headline[(R)] Fungicide as well as four supplemental labels for Pristine[(R)] Fungicide. Summary of directions for the proposed uses of pyraclostrobin were provided in Table 1.

Some of the proposed end use products contain two active ingredients pyraclostrobin and boscalid. However, this assessment focuses only on the active ingredient pyraclostrobin. No degradates of pyraclostrobin were included in the drinking water assessment based on the recommendation from the Metabolism Assessment Review Committee (MARC) of Health Effects Division (USEPA 2001, D278044). The EDWCs for both surface and ground water recommended for use in HED's human health dietary risk assessment are summarized in Table 2. Estimated pyraclostrobin concentrations in surface water and ground water used for drinking water are summarized in Table 6.
For the proposed use of pyraclostrobin in fruiting vegetables resulted in the highest surface water concentrations of at 16.6 ug/L for 1-10 year peak value from ground application and 1-10 annual year average of 1.1 ug/L from aerial application. The acute and chronic EDWCs resulting from the proposed application uses are lower than the EDWCs for surface water in the previously recommended drinking water assessments for pyraclostrobin for turf uses (USEPA 2007 D389729+). Since the EDWCs for surface water for proposed uses are lower than the previously recommended EDWCs for this chemical, the EDWCs for surface water will not supersede the EDWCs previously recommended for turf use. The Percent Cropped Area of 1.0 was assumed as pyraclostrobin has uses on ornamentals, turf, and a variety of agricultural crops. Revised EDWCs in groundwater superseded the EDWCs previously recommended for turf use. Recent monitoring data show pyraclostrobin detection of a maximum of 23.9 ng/L in surface water and a maximum of 4.8ng/L groundwater samples (Reilly et al., 2012).

Table 1. Proposed New Uses and Conversion of Old Crop Groups to New Crop Groups for Pyraclostrobin
                                   Use Site
                               Single App. Rate
                                (lbs. ai/A)[a]
                                   # of App
                              Seasonal App. Rate
                                 (lbs. ai/A)
                          Retreatment Interval (days)
                                      PHI
                                 App. Type[b]
                            Geographic Restrictions
                                  EPA Reg #
                                    Comments
                            Proposed New Uses  -
                               Artichoke (Globe)
                                 0.15 -  0.18
                                       3
                                     0.55
                                     7-14
                                       0
                                     A,G,S
                                     None
                                   7969-199
Begin app. At the initiation of the protection phase when approximately 25% of the plants have bolted.

                                Belgium Endive
                     0.8 to 1.6 oz. per 1000 lbs roots[c]
                                   7969-199
Application made to roots when brought into cold storage and at the beginning of forcing.
                                   Persimmon
                                 0.15  -  0.18
                                       3
                                     0.55
                                     7-14
                                       0
                                     A,G,S
                                     None
                     Prior to onset of disease development
                                   Sugarcane
                                   0.15-0.2
                                       4
                                     0.78
                                     14-28
                                      14
                                     A,G,S
                                     None
                                   7969-289
                            Residential Ornamentals
                                     0.156
                                       6
                                     0.93
                                      14
                                       0
                                     NS[d]
                                     None
                                   7969-GLG
                Conversion of old crop group to new crop group
                         Bulb vegetables (Group 3-07)
                                   0.1-0.15
                                       6
                                      0.9
                                      14
                                       7
                                     A,G,S
                                     None
                                   7969-199
                    Prior to onset of disease and continue
                       Bushberry and Caneberry subgroup
                                   (13-07B)
                                 0.15 -  0.18
                                       4
                                     0.73
                                     7-14
                                       0
                                     A,G,S
                               Not for use in CA
                                   7969-199
                    Prior to onset of disease and continue
                          Citrus Fruit Group (10-10)
                                 0.15  -  0.24
                                       4
                                     0.88
                                     10-21
                                       0
                                     A,G,S
                                     None
                                   7969-289
                    Prior to onset of disease and continue
                       Fruiting Vegetables Group (8-10)
                                  0.10-0.20
                                       6
                                      1.2
                                     5-14
                                       0
                                     A,G,S
                               Not for use in CA
                                   7969-187
                    Prior to onset of disease and continue
                Low growing berry subgroup (includes cranberry)
                                  (13-07G[)]
                                 0.15  -  0.18

                                       5
                                     0.92
                                     7-14
                                       0
                                     A,G,S
                                     None
                                   7969-187
     No later than 10% bloom or prior to disease development and continue
                            Oilseed crops Group 20
                                   0.10-0.20

                                       2
                                     0.39
                                     7-14
                                      21
                                     A,G,S
                                     None
                                   7969-289
Prior to disease development and continue...if conditions are conducive for disease development
                           Pome Fruit Groups (11-10)
                                 0.11  -  0.15
                                       4
                                     0.6
                                     7-14
                                       0
                                     A,G,S
                                     None
                                   7969-187
         Begin applications prior to disease development and continue.
                   Root vegetables, 1B (except sugar beets)
                                  0.06 - 0.17

                                       6
                                     0.52
                                     7-14
                                       0
                                      AGS
                                     None
                                   7969-199
         Begin applications prior to disease development and continue.
                  Small fruit, vine climbing subgroup 13-07F
                           (except fuzzy kiwifruit)
0.10  -  0.15
                                       6
                                      0.9
                                     10-21
                                      14
                                     A,G,S
                                     None
                                   7969-187
Prior to onset of disease when conditions favor disease during early bloom, bunch pre-closure and veraison.
                  Tomato transplants for homeonwers market[4]
                                  0.1 -  0.2

                                       2
                                      1.1
                                     5-14
                                       0
                                     A,G,S
                                     None
                   Prior to disease development and continue
                                 Turnip greens
0.15  -  0.20
                                       2
                                      0.4
                                     7-14
                                      14
                                     A,G,S
                                     None
                  Prior to disease development and continue.
a Adopted from "Summary of Directions for the Proposed Uses of Pyraclostrobin " provide by Registration Division (Appendix X)
b Application methods: Aerial (A), Ground (G) and Sprinkler (S)
[c] Indoor use, exposure to surface water and groundwater would be low. No exposure assessment was performed
[d] Not Specified, assumed hand spray
[4]  Since tomato is in the fruiting vegetable cropgroup, no separate exposure assessment was performed for drinking water.

Table 2.  Recommended EDWCs for Drinking Water risk assessment for  pyraclostrobin Use
Source of Drinking Water
            Pyraclostrobin concentration in drinking water (ug/L)

                                   Acute[1]
                             Non-Cancer Chronic[1]
                               Cancer Chronic[1]
Surface Water
                                     35.6
                                      2.3
                                      1.5
Groundwater[2]
                                     0.06
                                     0.02
                                     0.02
1 These are the highest EDWCs for previously evaluated use scenarios and the estimated acute and annual average surface water concentrations were 35.6 and 2.3 ug/L respectively.  Previously estimated groundwater concentrations for acute was  0.02 ug/L 2007, D389729+.
2 EDWCs based on PRZM-GW model

Proposed Uses

The Interregional Research Project Number 4 is seeking registration of several new uses (described in Table 1) of pyraclostrobin on one supplemental label for Cabrio[(R)] Fungicide and one supplemental label Headline[(R)] Fungicide as well as four supplemental labels for Pristine[(R)] Fungicide.

This assessment examines potential exposure to pyraclostrobin only.  Aerial, chemigation, and ground applications are proposed for the agricultural crops.   Five of the proposed uses were considered as not being previously assessed in drinking water assessments. These include use on globe artichoke, persimmon, low growing berries, sugarcane, and ornamentals (homeowner). Since aerial application provides higher exposure, major crops scenarios were simulated with aerial application. A ground application scenario was used to compare with the highest exposure scenario of aerial application (PA tomato STD). Resulted EDWCs for both aerial and ground are very comparable. Sprinkler irrigation assumed to be similar to ground application. An additional new use for Belgium endive was not considered in this assessment due to indoor use of pyraclostrobin.

Residues of Concern

The Metabolism Assessment Review Committee (MARC) reported that the residue of concern for pyraclostrobin in drinking water is the parent only (USEPA 2001, D278044).

Modeling Approach and Input Parameters

Models

	Surface Water
The EDWCs were generated using EFED's standard suite of models. Pesticide Root Zone Model (PRZM v3.12.2, May 12, 2005) and Exposure Analysis Modeling System (EXAMS v<IP_ADDRESS>, Apr. 25, 2005) are simulation models coupled with the input shell PRZM/EXAMS (PE v5.0, Nov. 15, 2006) to generate EDWCs of pyraclostrobin residues that may occur in surface water for drinking water.  The PRZM model simulates pesticide movement and transformation from crop application through soil residue processes.  The EXAMS model simulates pesticide loading via runoff, erosion, and spray drift assuming a standard watershed of 172.8 ha that drains into an adjacent standard drinking water index reservoir of 5.26 ha, an average depth of 2.74 m.  A more detailed description of the index reservoir watershed can be found in Jones et al., 1998.  Standard percent cropped areas (PCA) were used for proposed uses as estimates of the extent of watershed on which crops are grown. The default PCA of 1.0 was used for the proposed uses because pyraclostrobin can be used in both agricultural and non-agricultural settings (USEPA 2012).

      Ground Water

Screening Concentration in Ground Water (SCI-GROW v2.3, Jul. 29, 2003) is a regression model used as a screening tool to estimate pesticide concentrations found in ground water used as drinking water.  The SCI-GROW model and user's manual may also be downloaded from the EPA Water Models web-page (http://www.epa.gov/oppefed1/models/water/#scigrow).  PCAs are not used with the SCI-GROW model.

In addition, Tier 1 groundwater EDWCs for pyraclostrobin, resulting from its use on various crops were also derived using the PRZM-GW model (Pesticide Root Zone Model for Groundwater, version 1.0, August 31, 2012), with the GW-GUI (Graphical User Interface, version 1.0, August 31, 2012).  PRZM-GW is a one-dimensional, finite-difference model that estimates the concentrations of pesticides in groundwater.  It accounts for pesticide fate in the crop root zone by simulating pesticide transport and degradation through the soil profile after a pesticide is applied to an agricultural field.  PRZM-GW permits the assessment of multiple years of pesticide application (up to 100 years) on a single site.  Six standard scenarios, each representing a different region known to be vulnerable to groundwater contaminations, are available for use with PRZM-GW for risk assessment purposes. In PRZM-GW simulations, each of these standard scenarios was used.  PRZM-GW output values represent pesticide concentrations in a vulnerable groundwater supply that is located directly beneath a rural agricultural field following many years of pesticide application.

Input Parameters

A summary of the model input parameter values used in PRZM/EXAMS, SCI-GROW, and the PRZM_GW Models are in Table 3, Table 4, and Table 5 presented in respectively.   Input parameters were selected in accordance with EFED's "Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides," Version 2.1 (USEPA, 2009). Sample model output files are located in Appendix B.

Table 3. PRZM/EXAMS Input Parameters for Pyraclostrobin Proposed Uses
Parameter
Input Value
Source
Comment

                                   Use Site
Scenario and Application Date

 Artichoke (Globe)
    CA Row Crop RLF
Multiple application dates1
Label directions
See Section titled "Proposed Use" for full explanation

A combination of label directions and information related to crop profile in current scenarios for PRZM/EXAMS

 Bulb vegetable Group (3-07)
    CA Onion STD
  Multiple application dates
Label directions

 Bushberry and caneberry subgroup (13-07 A)
    OR Berries STD
Multiple application dates
Label directions

 Low growingberry (13-07G)
    CA Strawberry STD
    FL Strawberry STD
    Multiple application dates
Label directions

 Citrus Fruit Group (10-10)
     CA Citrus STD
     FL Citrus STD
Multiple application dates
Label directions

 Fruiting Vegetable Group (8-10)
    FL Tomato STD
    PA Tomato STD
    FL Pepper STD
Multiple application dates
Label directions
Not for use in CA

 Oilseed Group (20)
     MS Cotton STD
     NC Cotton STD
     ND Canola STD
Label directions

 Pome Fruit Group (11-10)
    NC Apple STD
    OR Apple STD
    PA Apple STD
Multiple application dates
Label directions

Root vegetables 1B
    FL Carrot
    ID Potato
    ME Potato
Multiple application dates
Label directions
(Except sugarbeet)

Small Fruit, vine climbing subgroup
    CA Grape STD
    NY Grape STD
Multiple application dates
Label directions
(Except fuzzy kiwifruit)

Sugercane
    FL Sugarcane STD
    LA Sugercane
Multiple application dates
Label directions

Turnip Greens
Label directions
Since the scenarios for turnip same as root vegetables and application rate for turnip is lower than the root vegetables group, no PRZM/EXAMS modeling was performed. Assumed EDWCs for turnip would be lower than the EDWCs for root vegetables

Ornamentals (Residential)
CA Residiential RLF
CA Impervious RLF

March 1

Label provides partial information related to application. Registration Division (personal communication) provided application rate and frequency of application.
Used similar approach described for Endengered Species Assessment
Residential scenario with 100% application rate
Impervious scenario with 1.68% of application rate
Post process for exposure[2]
Applications per year
See Table 2
Label directions
See Section titled "Proposed Use" for full explanation
Application method
Foliar-Aerial, ground and sprinkler irrigation

Label directions
Apply to all proposed uses
CAM
2

Default for foliar application
Hydrolysis (t1/2)
0
MRID 46902201
Stable
Spray drift fraction
Aerial: 0.16
Ground: 0.64
Sprinkler Irrigation:

PRZM/EXAMS input guidance document
Default for foliar application for drinking water assessment
Aerobic soil metabolism (t1/2)
 247.2 days
45118631
MRID 45118632
MRID 45367504
Upper 90[th] %-ile confidence bound on the mean of  six half-lives[3]
Aerobic aquatic metabolism (t1/2)
45.1 days
MRID 45118637
90[th]%ile reported half-lives for [14]C labeled chlorophenyl (8.4 days) and tolyl ( 26.4 days) rings.
Anaerobic aquatic metabolism (t1/2)
12.1 days
MRID 45118634
90[th]%ile reported half-lives for 14C labeled chlorophenyl (191 days) and tolyl ( 6.91 days)rings.
Aquatic photolysis (t1/2)
0.11 days
MRID 45118629
90[th]%ile reported half-lives for 14C labeled chlorophenyl (0.05 days) and tolyl ( 0.08)  days)rings.

Vapor pressure
6.88x10[--7] (mmHg)
--
MRID 470780-01to 470780-08
Solubility in water
(pH 7, 20 °C)
2.7mg/L
--

Molecular weight
388 g/mole
--

Henry's Law constant (20 °C)
1.3x10-7 atm.m3 /mol
--
Estimated1
Partition coefficient Koc
9304 mL/g
MRID 46808411
Average Koc  (7889, 16000, 7889, 6000, 9000, 9436, and 9304)
[1] = Since pyraclostrobin can be applied based on pest pressure, multiple application dates were used to simulates pyraclostrobin exposure in drinking water. Application dates and exposure were provided in appendix X
[2][(Residential EEC) x (0.5 amount pervious surface) x (% treated, 0.15 for woody ornamental)] + [Impervious Surface EEC x 0.5 amount impervious surface]
[3]= http://www.epa.gov/oppefed1/models/water/input_parameter_guidance.htm

Table 4. SCI-GROW (v2.3) Input Parameter Values for Pyraclostrobin
                                   Parameter
                                     Value
                                    Source
                                   Comments
Application Rate (lbs a.i./acre)
                                     0.184
                              EPA Reg # 7969-199
                                Proposed label
Number of applications
                                       5
                              EPA Reg # 7969-199

Koc (mL/g)
                                     9000
                                 MRID 46808411
Median of seven KOC values.  There is not a three fold difference in observed values.
Aerobic soil metabolism t (1/2) (days)
                                      161
                                 MRID 45118631
                                 MRID 45118632
                                 MRID 45367504
    Median of four values.  There was not a five-fold difference in values.

Table 1. Input values for the PRZM-GW model for ptraclostrobin.

                                 Variable Name

                                  Data Value
                                  Data Source
                                    MRID(s)
                                    Comment
Application Method
Aerial (fruiting vegetable),

Proposed labels
                               EPA Reg# 7969-187

Application Rate
(lbs. a.i./acre) [kg/ha]
0.20 [0.22] (fruiting vegetable),
Proposed labels
                               EPA Reg# 7969-187

Application Frequency
6 times per year
Proposed labels
                               EPA Reg# 7969-187

Application Interval (days)
5 days
Proposed labels
                               EPA Reg# 7969-187

Hydrolysis
t1/2 = stable
48409101
                               EPA Reg# 7969-187

Aerobic Soil Metabolism
t1/2 = 247.2days
45118631
MRID 45118632
MRID 45367504
     Upper 90[th] %-ile confidence bound on the mean of  six half-lives[1]
Koc
9304 mL/goc
MRID 46808411
Average Koc  (7889, 16000, 7889, 6000, 9000, 9436, and 9304)  [1]
[1] EFED input parameter guidance: http://www.epa.gov/oppefed1/models/water/przm_gw/wqtt_przm_gw_input_guidance.htm

Table 5. Modified Tier I Rice Model (for Estimating Exposure from Use on Cranberries) Input Parameters for Pyraclostrobin
Input Parameter
Value
Comments
Source
Application rate
(lbs a.i./A)
0.88
Maximum proposed annual application rate
Proposed label
Organic carbon partition coefficient (Koc) (L/kgOC)
9304
Represents the mean Koc value for parent (n=7)
MRID 46808411

Modeling Results

      Estimated pyraclotrobin concentrations in surface water and ground water used for drinking water are summarized in Table 6. Estimated concentrations in surface water for use on fruiting vegetable resulted in the highest EDWC at 16.6 ug/L for acute from ground application and annual average of EDWCs from aerial application.  Acute estimated pyraclotrobin concentrations in surface water used for drinking water for other uses ranged from 1.4 to 16.6 ug/L.  Estimated annual average concentrations ranged from 0.1to 0.9 ug/L.  SCIGROW model simulated concentrations in ground water was 6.2E-03 ug/L for the highest application rate. The SCIGROW and PRZM-GW concentrations represent groundwater concentration that might be expected in shallow unconfined aquifers under sandy soils. All  PRZM-GW scenarios , 3 required the use of an extended weather file, which allows the user to run the simulation for up to 100 years in order to observe breakthrough. PRZM_GW simulated groundwater concentrations are lower than SCIGROW model and  listed in Table 7 for six vulnerable sites.

Table 6.  EDWCs for Pyraclostrobin Applications to Various Crops and Home Owner Garden
Drinking Water Source
Crop
Crop Scenario
1-in-10-year Peak Exposure
1-in-10-year Annual Mean Exposure
                            30-year Mean Exposure

                             Concentration (ug/L)
Surface water[1]
Artichoke
CA Rowcrop_RLF

                                    2.2-3.1

                                      0.2

                                      0.1

Berry-bush/cane
OR Berry STD

                                    2.5-4.1

                                    0.3-0.4

                                      0.3

Berry-low growing
FL Strawberry STD

                                    4.8-5.1

                                    0.4-0.5

                                    0.3-0.4

Bulb vegetable
CA Onion STD

                                      1.6

                                      0.1

                                      0.1

Citrus
CA Citrus STD
FL Citrus STD

                                    1.9-2.0
                                    4.7-8.6

                                    0.1-0.2
                                      0.5

                                      0.1
                                    0.3-0.4

Fruiting vegetable
CA Tomato STD
FL Pepper STD
 FL Tomato STD
PA Tomato STD
PA Tomato STD (G)[2]

                                    2.0-2.7
                                    8.7-9.1
                                   8.8-10.9
                                   11.3-16.2
                                   11.2-16.6

                                    0.3-0.4
                                      0.8
                                    0.8-0.9
                                    0.8-1.1
                                    0.8-1.0

                                    0.2-0.3
                                      0.6
                                    0.7-0.6
                                    0.7-0.9
                                    0.6-0.8

Oilseed
MS Cotton STD
NC Cotton STD
ND Canola STD

                                    5.8-7.6
                                    .8-7.5
                                    1.9-2.8

                                    0.4-05
                                    0.3-04
                                      0.1

                                      0.3
                                      0.3
                                      0.1

Pome Fruits
NC Apple STD
OR Apple STD
PA Apple STD

                                    4.6-8.6
                                    3.9-6.1

                                    0.4-0.5
                                    0.2-0.3
                                    0.3-0.4

                                      0.3
                                      0.2
                                      0.2

Persimmon
NC Apple STD

                                    9.1-5.3

                                      0.4

                                      0.3

Root Vegetable
FL Carrot STD
ID Potato STD
ME Potato STD

                                    3.9-6.0
                                    1.7-1.8
                                    4.4-5.8

                                      0.4
                                      0.1
                                    0.4-0.5

                                      0.3
                                      0.1
                                    0.30.4

Small Fruit (Vine)
CA Grape STD
NY Grape STD

                                    1.4-1.7
                                   10.7-13.9

                                      0.2
                                    1.2-1.3

                                      0.2
                                      0.9

Sugarcane
FL Sugarcane STD
LA Sugarcane STD

                                    6.7-9.9
                                   9.6-13.8

                                  0.8-0.7-08
                                    0.9-1.0

                                   0.05-0.08
                                      0.7

Home Owner Garden-Woody Ornamental
CA Residential STD

                                      3.6

                                      0.2

                                       -
Groundwater
Generic  Scenario
                                   6.08E-03
                                   6.08E-03
                                   6.08E-03
1 = Surface water EDWCs are estimated for aerial application
[3] = The reported EDWCs are based on ground application to compare with the highest EDWCs for the PA Tomato scenario for aerial application.

Table 7. PRZM-GW results based on pyraclotrobin use.

                                     Crop
                                   Scenario
                                    Highest
                                     Daily
                                 Value (ug/L)
                       Post Breakthrough Average (ug/L)
                  Average Simulation Breakthrough Time (days)
Tomato
(0.20  lbs a.i./A x 6 applications)
FL citrus
                                   6.15E-02
                                   1.59E-02
                                  Incomplete

FL potato
                                   7.45E-11
                                   1.68E-11
                                  Incomplete

GA peanut
                                    1.59E10
                                   9.94E-12
                                  Incomplete

NC cotton
                                   4.88E-04
                                   1.24E-04
                                  Incomplete

DELMARVA sweet corn
                                   5.54E-05
                                   7.04E-06
                                  Incomplete

WI corn
                                    3.5E-09
                                   2.23E-10
                                  Incomplete

Monitoring Data

Data on pyraclostrobin were available in the United States Geological Survey (USGS) National Water-Quality Assessment (NAWQA) Program Data Warehouse (http://infotrek.er.usgs.gov/nawqa_queries/jsp/swmaster.jsp) searched on February 11, 2013.  Pyraclostrobin was not detected in the surface water samples collected in Georgia (limit of quantitation (LOQ) = 2.8 ng/L). Ten bottom material samples were also collected in Georgia and pyraclostrobin was not detected  (LOQ =1.6 ug/kg-sediment) in all ten samples. However, recently Reilly et al. (2012) reported pyraclostrobin residues in surface water and groundwater samples.  For surface water, a total of 60 water samples were analyzed for pyraclostrobin.  Pyraclostrobin was detected in 42% of surface water samples.  The maximum concentration of pyraclostrobin in surface water was 23.9 ng/L.  For groundwater, a total of 12 water samples were analyzed for pyraclostrobin.  Pyraclostrobin was detected in 40% of ground water samples.  The maximum concentrations of pyraclostrobin ranged from non-detect to 4.8 ng/L.

Drinking Water Treatment

There is no available information on the effects of drinking water treatment on pyraclostrobin.  The EDWCs in this assessment are representative of concentrations in drinking water source water (pre-treatment).  For surface water, the conceptual model assumes that a pesticide reaches surface water via spray drift or surface runoff and it is instantaneously mixed and concentrations are observed in the water body.  Pyraclostrobin is stable to hydrolysis.  Therefore, pyraclostrobin will not degrade by hydrolysis during the time that elapses from drinking water intake through distribution to the first tap.  Pyraclostrobin is also stable to aqueous photolysis.  Therefore, if ultraviolet light were used as a means of disinfection, degradation of pyraclostrobin would not be expected to be significant.  Pyraclostrobin has long degradation rate in aerobic aquatic metabolism and aerobic metabolism is therefore, not expected to be a significant loss mechanism in water treatment.  The most successful drinking water treatment process for removal of pesticides from drinking water is thought to be treatment with granular activated carbon (GAC) which is only used in larger drinking water treatment facilities.  The ability of GAC to remove pesticides will vary with the properties of the chemical, the viability of the biofilm on the GAC, and whether the sorption sites on GAC have reached capacity (Badriyha et al., 2003; Zhao et al., 1999).  Data on the sorption of pyraclostrobin to GAC are not available; however, high Koc (9304 mL/g) value of pyraclostrobin suggests that there is a potential for removal of pyraclostrobin through GAC treatment due to its high adsorption coefficient.

Uncertainties

The highest estimated concentrations provided in this assessment were generated from Tier 1 models and are conservative estimates of pyraclostrobin concentrations in untreated drinking water.  There were a number of uncertainties associated with this drinking water exposure assessment.  The major uncertainty is from the use of the Tier I Rice Model with a modified depth for cranberries.  This model only estimates a peak concentration inside the bog.  Therefore, it likely overestimates chronic concentrations and is expected to be conservative for acute/peak EDWC as water will have a residence time between leaving a cranberry bog and reaching a drinking water intake.  Additionally, the model was originally developed for rice and management of cranberries is different than rice and the model was not validated using monitoring data for cranberries.  Therefore, there is some uncertainty in using the model for cranberries.  Additionally, the Tier I Rice Model does not account for degradation and the annual average EDWC is likely overestimated; however, due to pyraclostrobin's stability in water, the overestimation may not be that high.

An additional element of uncertainty derives from the conceptual model used in this assessment, whereby applications of pesticide are made to a single bog.  In reality, the water used to flood a cranberry bog may be "recycled" and used to flood multiple bogs, and/or stored and used to re-flood the same bog later during the year.  Thus, the same volume of water may receive greater pesticide loadings than label restrictions would seem to imply.   Additionally, applications may be made to dry cranberry bogs that are subsequently flooded.

Literature Cited

Jones, R. D., S. Abel, W. R. Effland, R. Matzner, R. Parker.  1998.  An Index Reservoir for Use in Assessing Drinking Water Exposure.  Proposed Methods for Basin-scale Estimation of Pesticide Concentrations in Flowing Water and Reservoirs for Tolerance Reassessment.  Presentation to FIFRA Science Advisory Panel, June 29-30, 1998.  Online at: http://www.epa.gov/scipoly/sap/1998/index.htm

Reilly, T.J., Smalling, K.L., Orlando, J.L. and K.M. Kuivila. 2012.  Occurrence of boscalid and other selected fungicides in surface water and groundwater in three targeted use areas in the United States. Chemosphere 89:228-234.

USEPA, 2007.  Pyraclostrobin. Outcome the the HED Metabolism Assessment Review Committee  (MARC) Meeting Held on September 20, 2001. Health Effects Division.  Office of Pesticide Programs. United States Environmental Protection Agency (D 278044).

USEPA, 2007.  Drinking water assessment for turf and golf courses. Environmental Fate and Effects Division.  Office of Pesticide Programs. United States Environmental Protection Agency (D D389729+.

USEPA. 2009. Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides, Version 2.1.  Environmental Fate and Effects Division.  Office of Pesticide Programs. United States Environmental Protection Agency. Available at http://www.epa.gov/oppefed1/models/water/input_parameter_guidance.htm (Accessed February 10, 2013).

USEPA. 2010. Guidance on Development and Use of Percent Cropped Area Adjustment Factors in Drinking Water Exposure Assessments.  Environmental Fate and Effects Division, Office of Pesticide Programs, United States Environmental Protection Agency. Available at http://www.epa.gov/oppefed1/models/water/pca_adjustment_dwa.pdf (Accessed November 29, 2010).

Zhao, X., Hickey, R. F., & Voice, T. C. 1999.  Long-term evaluation of adsorption capacity in a biological activated carbon fluidized bed reactor system. Water Research, 33(13).

                           Appendix A: Model Outputs
Model: PRZM/EXAMS

stored as PATomG_DW_15-07.out

Chemical: Pyraclostrobin

PRZM environment: PAtomatoSTD.txt, modified Tueday, 29 May 2007 at 14:01:58
EXAMS environment: ir298.exv, modified Tueday, 26 August 2008 at 06:14:08
Metfile: w14751.dvf, modified Tueday, 26 August 2008 at 06:15:00
                      Water segment concentrations (ppb)

                                     Year
                                     Peak
                                     96 hr
                                    21 Day
                                    60 Day
                                    90 Day
                                    Yearly

                                     1961
                                      5.9
                                      5.1
                                      2.7
                                      1.5
                                      1.1
                                      0.4

                                     1962
                                      6.5
                                      5.3
                                      2.7
                                      1.9
                                      1.7
                                      0.8

                                     1963
                                      6.7
                                      5.5
                                      2.9
                                      2.3
                                      1.7
                                      0.7

                                     1964
                                      3.3
                                      2.8
                                      1.9
                                      1.4
                                      1.2
                                      0.7

                                     1965
                                      3.6
                                      3.1
                                      1.9
                                      1.1
                                      0.9
                                      0.5

                                     1966
                                     17.5
                                     14.1
                                      7.1
                                      3.3
                                      2.6
                                      1.0

                                     1967
                                      4.0
                                      3.3
                                      2.3
                                      1.5
                                      1.2
                                      0.7

                                     1968
                                     16.1
                                     12.8
                                      6.2
                                      2.9
                                      2.3
                                      0.8

                                     1969
                                      8.9
                                      7.1
                                      4.5
                                      2.1
                                      1.6
                                      0.6

                                     1970
                                      4.5
                                      3.6
                                      2.0
                                      1.4
                                      1.0
                                      0.7

                                     1971
                                      5.4
                                      4.5
                                      2.5
                                      1.8
                                      1.3
                                      0.7

                                     1972
                                      7.1
                                      5.9
                                      4.5
                                      2.7
                                      1.8
                                      1.0

                                     1973
                                     16.6
                                     13.3
                                      6.6
                                      3.2
                                      2.4
                                      1.0

                                     1974
                                      9.5
                                      7.8
                                      4.7
                                      2.4
                                      1.9
                                      0.9

                                     1975
                                     24.5
                                     19.7
                                     10.6
                                      5.1
                                      3.7
                                      1.2

                                     1976
                                     10.5
                                      8.6
                                      4.9
                                      3.0
                                      2.4
                                      1.0

                                     1977
                                      2.4
                                      2.1
                                      1.6
                                      1.3
                                      1.2
                                      0.6

                                     1978
                                      1.8
                                      1.5
                                      1.1
                                      0.9
                                      0.9
                                      0.5

                                     1979
                                      7.6
                                      6.2
                                      4.1
                                      2.5
                                      1.8
                                      1.0

                                     1980
                                      8.1
                                      6.6
                                      3.4
                                      2.6
                                      1.9
                                      0.6

                                     1981
                                      4.6
                                      3.7
                                      2.0
                                      1.2
                                      1.0
                                      0.6

                                     1982
                                      3.3
                                      2.7
                                      1.5
                                      0.9
                                      0.7
                                      0.5

                                     1983
                                      5.8
                                      5.0
                                      3.3
                                      2.2
                                      1.9
                                      0.8

                                     1984
                                      3.4
                                      2.8
                                      1.5
                                      1.1
                                      1.0
                                      0.6

                                     1985
                                      5.6
                                      4.5
                                      2.3
                                      1.5
                                      1.4
                                      0.6

                                     1986
                                      5.1
                                      4.1
                                      2.3
                                      1.3
                                      1.0
                                      0.7

                                     1987
                                      8.5
                                      7.0
                                      5.6
                                      2.8
                                      2.4
                                      0.9

                                     1988
                                      3.7
                                      3.0
                                      1.6
                                      1.0
                                      0.7
                                      0.5

                                     1989
                                      8.3
                                      6.7
                                      3.7
                                      1.9
                                      1.8
                                      0.8

                                     1990
                                      6.1
                                      5.0
                                      2.8
                                      1.8
                                      1.7
                                      0.8

Sorted results

                                     Prob.
                                     Peak
                                     96 hr
                                    21 Day
                                    60 Day
                                    90 Day
                                    Yearly

                                      0.0
                                     24.5
                                     19.7
                                     10.6
                                      5.1
                                      3.7
                                      1.2

                                      0.1
                                     17.5
                                     14.1
                                      7.1
                                      3.3
                                      2.6
                                      1.0

                                      0.1
                                     16.6
                                     13.3
                                      6.6
                                      3.2
                                      2.4
                                      1.0

                                      0.1
                                     16.1
                                     12.8
                                      6.2
                                      3.0
                                      2.4
                                      1.0

                                      0.2
                                     10.5
                                      8.6
                                      5.6
                                      2.9
                                      2.4
                                      1.0

                                      0.2
                                      9.5
                                      7.8
                                      4.9
                                      2.8
                                      2.3
                                      1.0

                                      0.2
                                      8.9
                                      7.1
                                      4.7
                                      2.7
                                      1.9
                                      0.9

                                      0.3
                                      8.5
                                      7.0
                                      4.5
                                      2.6
                                      1.9
                                      0.9

                                      0.3
                                      8.3
                                      6.7
                                      4.5
                                      2.5
                                      1.9
                                      0.8

                                      0.3
                                      8.1
                                      6.6
                                      4.1
                                      2.4
                                      1.8
                                      0.8

                                      0.4
                                      7.6
                                      6.2
                                      3.7
                                      2.3
                                      1.8
                                      0.8

                                      0.4
                                      7.1
                                      5.9
                                      3.4
                                      2.2
                                      1.8
                                      0.8

                                      0.4
                                      6.7
                                      5.5
                                      3.3
                                      2.1
                                      1.7
                                      0.8

                                      0.5
                                      6.5
                                      5.3
                                      2.9
                                      1.9
                                      1.7
                                      0.7

                                      0.5
                                      6.1
                                      5.1
                                      2.8
                                      1.9
                                      1.7
                                      0.7

                                      0.5
                                      5.9
                                      5.0
                                      2.7
                                      1.8
                                      1.6
                                      0.7

                                      0.5
                                      5.8
                                      5.0
                                      2.7
                                      1.8
                                      1.4
                                      0.7

                                      0.6
                                      5.6
                                      4.5
                                      2.5
                                      1.5
                                      1.3
                                      0.7

                                      0.6
                                      5.4
                                      4.5
                                      2.3
                                      1.5
                                      1.2
                                      0.7

                                      0.6
                                      5.1
                                      4.1
                                      2.3
                                      1.5
                                      1.2
                                      0.6

                                      0.7
                                      4.6
                                      3.7
                                      2.3
                                      1.4
                                      1.2
                                      0.6

                                      0.7
                                      4.5
                                      3.6
                                      2.0
                                      1.4
                                      1.1
                                      0.6

                                      0.7
                                      4.0
                                      3.3
                                      2.0
                                      1.3
                                      1.0
                                      0.6

                                      0.8
                                      3.7
                                      3.1
                                      1.9
                                      1.3
                                      1.0
                                      0.6

                                      0.8
                                      3.6
                                      3.0
                                      1.9
                                      1.2
                                      1.0
                                      0.6

                                      0.8
                                      3.4
                                      2.8
                                      1.6
                                      1.1
                                      1.0
                                      0.5

                                      0.9
                                      3.3
                                      2.8
                                      1.6
                                      1.1
                                      0.9
                                      0.5

                                      0.9
                                      3.3
                                      2.7
                                      1.5
                                      1.0
                                      0.9
                                      0.5

                                      0.9
                                      2.4
                                      2.1
                                      1.5
                                      0.9
                                      0.7
                                      0.5

                                      1.0
                                      1.8
                                      1.5
                                      1.1
                                      0.9
                                      0.7
                                      0.4

                                      0.1
                                     16.6
                                     13.3
                                      6.6
                                      3.2
                                      2.4
                                      1.0

                          Average of yearly averages:
                                      0.7

Inputs generated by pe5.pl - Novemeber 2006

Data used for this run:

Output File: PATomG_DW_15-07

Metfile:
w14751.dvf

PRZM scenario:
PAtomatoSTD.txt

EXAMS environment file:
ir298.exv

Chemical Name:
Pyraclostrobin

Description
Variable Name
Value
Units
Comments

Molecular weight
mwt
                                                                            388
g/mol

Henry's Law Const.
henry
                                                                       1.30E-07
atm-m^3/mol

Vapor Pressure
vapr
                                                                       6.88E-07
torr

Solubility
sol
                                                                            2.7
mg/L

Kd
Kd

mg/L

Koc
Koc
                                                                           9304
mg/L

Photolysis half-life
kdp
                                                                           0.11
days
Half-life

Aerobic Aquatic Metabolism
kbacw
                                                                           45.1
days
Halfife

Anaerobic Aquatic Metabolism
kbacs
                                                                           12.1
days
Halfife

Aerobic Soil Metabolism
asm
                                                                          247.2
days
Halfife

Hydrolysis:
pH 7
                                                                              0
days
Half-life

Method:
CAM
                                                                              2
integer
See PRZM manual

Incorporation Depth:
DEPI
                                                                              0
cm

Application Rate:
TAPP
                                                                           0.22
kg/ha

Application Efficiency:
APPEFF
                                                                           0.99
fraction

Spray Drift
DRFT
                                                                          0.064
fraction of application rate applied to pond
Application Date
Date
15-07
dd/mm or dd/mmm or dd-mm or dd-mmm
Interval 1
interval
                                                                              7
days
Set to 0 or delete line for single app.
app. rate 1
apprate
                                                                            0.2
kg/ha

Interval 2
interval
                                                                             14
days
Set to 0 or delete line for single app.
app. rate 2
apprate
                                                                            0.2
kg/ha

Interval 3
interval
                                                                              7
days
Set to 0 or delete line for single app.
app. rate 3
apprate
                                                                            0.2
kg/ha

Interval 4
interval
                                                                             14
days
Set to 0 or delete line for single app.
app. rate 4
apprate
                                                                            0.2
kg/ha

Interval 5
interval
                                                                              7
days
Set to 0 or delete line for single app.
app. rate 5
apprate
                                                                            0.2
kg/ha

Record 17:
FILTRA

IPSCND
                                                                              1

UPTKF

Record 18:
PLVKRT

PLDKRT

FEXTRC
                                                                            0.5

Flag for Index Res. Run
IR
Reservoir

Flag for runoff calc.
RUNOFF
total
none, monthly or total(average of entire run)

Model SCIGROW

                                    SCIGROW
                                  VERSION 2.3
                    ENVIRONMENTAL FATE AND EFFECTS DIVISION
                         OFFICE OF PESTICIDE PROGRAMS
                     U.S. ENVIRONMENTAL PROTECTION AGENCY
                                SCREENING MODEL
                        FOR AQUATIC PESTICIDE EXPOSURE

                              SciGrow version 2.3
                            chemical:Pyraclostrobin
                         time is  2/10/2013   7:50:44
   ------------------------------------------------------------------------
      Application      Number of       Total Use    Koc      Soil Aerobic
    rate (lb/acre)  applications   (lb/acre/yr)  (ml/g)   metabolism (days)
   ------------------------------------------------------------------------
         0.156           6.0           0.936      9.00E+03      161.0
   ------------------------------------------------------------------------
                 groundwater screening cond (ppb) =   6.18E-03
   ************************************************************************

Model PRZM_GW


[Federal Register Volume 77, Number 2 (Wednesday, January 4, 2012)]
[Notices]
[Pages 313-315]
[FR Doc No: 2011-33715]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66062; File No. SR-NYSEArca-2011-98]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Deleting NYSE Arca
Equities Rule 7.31(w)(1) to Remove the PNP Plus Order Type

December 28, 2011.
    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 December 21, 2011, NYSE Arca, Inc. (the ``Exchange'' or ``NYSE
Arca'') filed with

the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to delete NYSE Arca Equities Rule 7.31(w)(1)
to remove the PNP Plus Order type. The text of the proposed rule change
is available at the Exchange, the Commission's Public Reference Room,
and www.nyse.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, the self-regulatory organization
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 those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to delete NYSE Arca Equities Rule 7.31(w)(1)
to remove the PNP (Post No Preference) Plus order type.
    By its terms, a PNP Order is a limit order to buy or sell that is
to be executed in whole or in part on the Exchange, and the portion
that is not executed is ranked on the Exchange's order book without
routing any portion of the order to another market center.\3\ Pursuant
to NYSE Arca Equities Rule 7.31(w)(1), for any portion of a PNP Order
designated as a PNP Plus Order that remains unexecuted and would
otherwise lock or cross the best protected bid or offer (``PBBO''),
Exchange systems would automatically re-price the PNP Plus Order to a
penny better than the Best Protected Bid (for sell orders) or a penny
lower than the Best Protected Offer (for buy orders). Exchange systems
would continue to re-price a PNP Plus Order with each change of the
PBBO until such time that the PBBO has moved to a price where the
original price of the PNP Plus Order would no longer result in a locked
or crossed market, at which time the PNP Plus Order would revert to the
original price of the order.
---------------------------------------------------------------------------

    \3\ See NYSE Arca Equities Rule 7.31(w).
---------------------------------------------------------------------------

    The Exchange proposes to delete Rule 7.31(w)(1) and all references
to the PNP Plus Order type. The rule was adopted, in part, to provide
ETP Holders with an additional processing capability for PNP Orders.\4\
However, since it was adopted, the PNP Plus Order type has not been
used by ETP Holders. In addition, the functionality associated with PNP
Plus Orders causes system instability, and as a result, the system
functionality has not been operable.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No.49942 (June 29,
2004), 69 FR 41005 (July 7, 2004) (SR-PCX-2004-12).
---------------------------------------------------------------------------

    In reviewing this system functionality, the Exchange has also
identified that the operation of the PNP Plus Order may conflict with
the proposed Plan pursuant to Rule 608 of Regulation NMS to Address
Extraordinary Market Volatility (the ``Limit Up-Limit Down Plan'' or
``Plan''), which the equities exchanges and the Financial Industry
Regulatory Authority, Inc., filed with the Securities and Exchange
Commission in April 2011.\5\ The Limit Up-Limit Down Plan is designed
to prevent trades from occurring outside of specified price bands. The
Exchange believes that if the best protected bid (offer) is below
(above) the Lower (Upper) Price Band, as defined in the Plan, the
automatic re-pricing of PNP Plus Orders may result in an offer (bid)
being repriced either at the Lower (Upper) Price Band, potentially
causing the market to enter a Limit State, as defined in the Plan, or
below (above) the Lower (Upper) Price Band, in violation of the Plan.
Accordingly, as part of the Exchange's system development efforts for
the Limit Up-Limit Down Plan, the Exchange has determined to remove the
PNP Plus Order functionality.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 64547 (May 25,
2011), 76 FR 31647 (June 1, 2011) (File No. 4-631).
---------------------------------------------------------------------------

2. Statutory Basis
    The statutory basis for the proposed rule change is Section 6(b)(5)
of the Securities Exchange Act of 1934 (the ``Act''),\6\ which requires
the rules of an exchange to promote just and equitable principles of
trade, 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. The proposed rule change also is
designed to support the principles of Section 11A(a)(1) \7\ of the Act
in that it seeks to assure fair competition among brokers and dealers
and among exchange markets. The Exchange believes that the proposed
rule change will perfect the mechanism of a free and open market
because it removes an order type that is not used by ETP Holders and
that causes system function instability. In addition, the Exchange
believes it is appropriate and desireable to remove the PNP Plus Order
type because it would further the Exchange's system development effort
in support of the proposed Limit Up-Limit Down Plan. By eliminating
this order type and the system functionality that supports it, the
Exchange will be better positioned to meet the target implementation
date for the Plan, and assure that the Exchange's systems will operate
in a manner that effectively and efficiently implements the Limit Up-
Limit-Down Rule. As such, this proposed rule change furthers the goal
of a free and open market and national market system.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b)(5).
    \7\ 15 U.S.C. 78k-1(a)(1).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose 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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \8\ and Rule 19b-4(f)(6) thereunder.\9\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
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, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A)

of the Act \10\ and Rule 19b-4(f)(6) \11\ thereunder.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file 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.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend 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. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2011-98 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2011-98. This
file number should be included on the subject line if email 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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. 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-NYSEArca-2011-98 and should
be submitted on or before January 25, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-33715 Filed 1-3-12; 8:45 am]
BILLING CODE 8011-01-P