Chemical-specific DFR data was previously submitted by the registrant to support earlier registration requests for food crops.  An overview of each study was provided in a previous assessment (D269670, K. O'Rourke, 9/30/2002).  Pyraclostrobin DFR studies were conducted on peaches, peanuts, strawberries, and grapes.  PMRA performed the primary review of these data, and considered the results useful for risk assessment purposes.  It should be noted that PMRA used the DFR data only to calculate percent dissipation per day and half-lives.  Therefore, HED went back to the initial study to calculate the DFR on day zero based on the results of the DFR study.   The calculated DFR values on day zero were used in the post-application dermal assessments.  The PA peach DFR data, which resulted in the highest DFR values of the three study sites, were used in the persimmon assessment.  The CA strawberry DFR data, which also resulted in the highest DFR values of the three study sites, were used in the artichoke and greenhouse tomato assessments.  The TX peanut DFR data, which resulted in the highest DFR values of the three study sites, were used in the sugarcane assessment.  The peanut DFR data were selected for use in the sugarcane assessment because the climate of regions where both of these crops are grown is very similar.  The DFR data used in this assessment are presented in Appendix F, Tables F-1 through F-3.

Occupational Post-application Non-Cancer Dermal Risk Estimates
The short- and intermediate-term non-cancer post-application risk estimates for workers are provided in Appendix E, Table E-3.  All post-application scenarios resulted in MOEs greater than 100 on day 0 (12 hours after application), and therefore, are not of concern to HED.  The MOEs for pyraclostrobin ranged from 120 to 12,000.

Restricted Entry Interval
The REI specified on the proposed label is based on the acute toxicity of pyraclostrobin. Pyraclostrobin is classified as Toxicity Category III via the dermal route and for skin and eye irritation potential.  It is not a skin sensitizer.  Under 40 CFR 156.208 (c) (2) (iii), ai's classified as Acute III or IV for acute dermal, eye irritation and primary skin irrigation are assigned a 12-hour REI.  Furthermore, the short- and intermediate-term post-application risk estimates were not a concern on day 0 (12 hours following application) for all post-application activities.  Therefore, the [156 subpart K] Worker Protection Statement interim REI of 12 hours is adequate to protect agricultural workers from post-application exposures to pyraclostrobin.

9.2.2	Inhalation Post-Application Risk

Based on the Agency's current practices, a quantitative post-application inhalation exposure assessment was not performed for pyraclostrobin at this time primarily because of the low vapor pressure (1.9 x 10[-8] mm Hg at 20 degrees C) and the low proposed use rate (0.2 lb ai/A).  However, there are multiple potential sources of post-application inhalation exposure to individuals performing post-application activities in previously treated fields.  These potential sources include volatilization of pesticides and resuspension of dusts and/or particulates that contain pesticides.  The Agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and received the SAP's final report on March 2, 2010. The Agency is in the process of evaluating the SAP report as well as available post-application inhalation exposure data generated by the ARTF and may, as appropriate, develop policies and procedures, to identify the need for and, subsequently, the way to incorporate occupational post-application inhalation exposure into the Agency's risk assessments.  If new policies or procedures are put into place, the Agency may revisit the need for a quantitative occupational post-application inhalation exposure assessment for pyraclostrobin.

Although a quantitative occupational post-application inhalation exposure assessment was not performed, an inhalation exposure assessment was performed for occupational/commercial handlers.  Handler exposure resulting from application of pesticides outdoors is likely to result in higher exposure than post-application exposure.  Therefore, it is expected that these handler inhalation exposure estimates would be protective of most occupational post-application inhalation exposure scenarios.

The Worker Protection Standard for Agricultural Pesticides contains requirements for protecting workers from inhalation exposures during and after greenhouse applications through the use of ventilation requirements [40 CFR 170.110, (3) (Restrictions associated with pesticide applications)].

10.0	References

S. Funk, 4/30/13, DP403449.  Pyraclostrobin:  Request for the Use on Sugarcane.  Summary of Analytical Chemistry and Residue Data.

S. Funk, 4/30/13, DP398877.  Boscalid and Pyraclostrobin:  Application by Bonide Products, Inc. to Register an End Use Product Containing Pyraclostrobin, Boscalid, and Lambda Cyhalothrin for Homeowner Use on Pome Fruit, Stone Fruit, and Tree Nuts.

S. Funk, 4/30/13, DP406471.  Pyraclostrobin and Boscalid:   Request to Add Indoor Use on Greenhouse Tomato for Commercial Production and on Greenhouse/Lathhouse Transplants for Consumer Home Market. Pagent(TM) Fungicide Reg. No. 7969-251.

S. Funk, 6/24/13, DP410737.  Amended: Pyraclostrobin:  Petition for the Establishment of Permanent Tolerances and Registration for Use on Belgium Endive, Persimmon, and Globe Artichoke. Request for Crop Group Expansions/Revisions for Bulb Vegetable Group 3-07, Fruiting Vegetable 8-10,  Citrus Fruit Group 10-10, Pome Fruit Group 11-10, Berry Subgroups 13-07A, B, F, and G, and Oilseed Group 20. Summary of Analytical Chemistry and Residue Data

S. Funk, 4/30/13, DP410739.  Pyraclostrobin. Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments to Support New Uses on Sugarcane, Persimmon, Globe Artichoke, and Belgium Endive.

C. Walls, 4/30/13, DP403449.  Pyraclostrobin.  Occupational and Residential Exposure Assessment for proposed new uses of pyraclostrobin on sugarcane, globe artichoke, Belgium endive, persimmon, greenhouse grown tomato transplants grown for home consumer market, and residential ornamentals, landscape gardens, fruit trees and nut trees.

F. Khan, 4/4/13, DP403871.  Addendum of Drinking Water Exposure Assessment for the Section 3 New Uses of Pyraclostrobin on Various Agricultural Crops and Residential Ornamentals.

S. Haddad, 11/18/2012, SIAB/BEAD, Screening Level Estimates of Agricultural Uses (SLUA) for the Fungicide Pyraclostrobin (099100)

Appendix A.  Toxicology Profile and Executive Summaries

A.1	Toxicology Data Requirements

The requirements (40 CFR 158.500) for food uses are in the table below. Use of the new guideline numbers does not imply that the new (1998) guideline protocols were used.

Table A.1: Toxicology Studies
                                   Required
                                   Submitted
                                   Satisfied
870.1100	Acute Oral Toxicity
870.1200	Acute Dermal Toxicity
870.1300	Acute Inhalation Toxicity
870.2400	Acute Eye Irritation
870.2500	Acute Dermal Irritation
870.2600	Skin Sensitization
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
870.3100	90-Day Oral Toxicity in Rodents
870.3150	90-Day Oral Toxicity in Non-Rodents
870.3200	21/28-Day Dermal Toxicity
870.3250	90-Day Dermal Toxicity
870.3465	90-Day Inhalation Toxicity
                                      yes
                                      yes
                                      yes
                                    no (CR)
                                   yes (CR)
                                      yes
                                      yes
                                      yes
                                      no
                                      yes
                                      yes
                                      yes
                                      yes
                                      ---
                                      yes
870.3700	Prenatal Developmental Toxicity Study (Rodent)
870.3700	Prenatal Developmental Toxicity Study (Non-Rodent)
870.3800	Reproduction and Fertility Effects
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
870.4100	Chronic Toxicity (Rodent)
870.4100	Chronic Toxicity (Non-Rodent)
870.4200	Carcinogenicity (Two Rodent Species; Rat and Mouse)
870.4300	Combined Chronic Toxicity/Carcinogenicity
                                      yes
                                      no
                                      yes
                                      no
                                      yes
                                      yes
                                      yes
                                      no
                                      yes
                                      ---
                                      yes
                                      yes
870.5100	Bacterial Reverse Mutation Test
870.5300	in vitro Mammalian Cell Gene Mutation Test
870.5375	in vitro Mammalian Chromosome Aberration Test
870.5385	Mammalian Bone Marrow Chromosomal Aberration Test
870.5395	Mammalian Erythrocyte Micronucleus Test
870.5550	Unscheduled DNA Synthesis in Mammalian Cells in Culture
                                      yes
                                      yes
                                      yes
                                      ---
                                    yes
no
                                      yes
                                      yes
                                      yes
                                      no
                                      yes
                                      yes
                                      yes
                                      yes
                                      yes
                                      ---
                                      yes
                                      ---
870.6100	Delayed Neurotoxicity of Organophosphorus Substances (Acute, Hen)
870.6100	Delayed Neurotoxicity of Organophosphorus Substances (28-Day, Hen)
870.6200	Neurotoxicity Screening Battery (Acute, Rat)
870.6200	Neurotoxicity Screening Battery (Subchronic, Rat)
870.6300	Developmental Neurotoxicity Study
                                    no (CR)
                                    no (CR)
                                      yes
                                      yes
                                    no (CR)
                                      no
                                      no
                                      yes
                                      yes
                                      no
                                      ---
                                      ---
                                      yes
                                      yes
                                      ---
870.7200	Companion Animal Safety
870.7485	Metabolism and Pharmacokinetics
870.7600	Dermal Penetration
	in vitro Dermal Penetration
870.7800	Immunotoxicity
                                    no (CR)
                                      yes
                                    no (CR)
                                      no
                                      yes
                                      no
                                      yes
                                      yes
                                      no
                                      yes
                                      ---
                                      yes
                                      ---
                                      ---
                                      ---
CR: Conditionally Required

A.2	Toxicity Profiles

 Table A.2.1.  Acute Toxicity of Pyraclostrobin

Table A.2.1: Acute Toxicity Profile
                                   Guideline
                                  Study Type
                                     MRID
                                    Results
                               Toxicity Category
                                   870.1100
Acute Oral Toxicity
                                   45118302
LD50 >= 5000 mg/kg
                                      IV
                                   870.1200
Acute Dermal Toxicity
                                   45118305
LD50 >2000 mg/kg
                                      III
                                   870.1300
Acute Inhalation Toxicity
                                   45118308
0.31 mg/L < LC50 < 1.07 mg/L
                                      II
                                   870.2400
Acute Eye Irritation
                                   45118311
Minimal Eye Irritation
Maximum Average Score (MAS): 4.6 / 110
24 hr Maximum Irritation Score (MIS): 6.3 / 110
                                      III
                                   870.2500
Acute Dermal Irritation
                                   45118314
Moderate Skin Irritation
Maximum Average Score (MAS): 2.2 / 8.0
24 h Maximum Irritation Score (MIS): 2.7 / 8.0
                                      III
                                   870.2600
Dermal Sensitization
                                   45118317
Not a dermal sensitizer
                                      N/A

 Table A.2.2.  Non-acute Toxicity Profile for Pyraclostrobin

Table A.2.2. Subchronic, Chronic, and Other Toxicity Profiles
                                   Guideline
                                  Study Type
                     MRID (year) / Doses / Classification
                                    Results
                                   870.3050
Repeated Dose
28-Day Oral Toxicity in Rodents (Rat)

45118322 (1999)
Dietary Concentration (ppm):
		0,	20,	100,	500, 	1500
Intake Dose (mg/kg/day):
	M:	0,	1.8,	9.0,	42.3, 	120.2
	F:	0,	2.0,	9.6,	46.6, 	126.3
Acceptable / Guideline

NOAEL (mg/kg/day):	M =	9.0	F =	9.6
LOAEL (mg/kg/day):	M =	42.3	F =	46.6
Based on changes in hematology parameters, increased spleen weight (both absolute and relative), and histopathology in the spleen and liver, in addition to increased duodenal mucosal hyperplasia.
                                   870.3100
90-Day Oral Toxicity in Rodents (Rat)
45118321 (1999)
45118322 (1999)  -  Dose Selection
Dietary Concentration (ppm):
		0,	50,	150,	500, 	1000	1500
Intake Dose (mg/kg/day):
	M:	0,	3.5,	10.7,	34.7, 	68.8,	105.8
	F:	0,	4.2,	12.6,	40.8, 	79.7, 	118.9
Acceptable / Guideline

NOAEL (mg/kg/day):	M =	10.7	F =	12.6
LOAEL (mg/kg/day):	M =	34.7	F =	40.8
Based on decreased body weights/body weight gains (males), decreased food consumption, increased relative liver weight and absolute and relative spleen weight in females, and histopathology of the duodenum, spleen and liver.

90-Day Oral Toxicity in Rodents (Mouse)
45118320 (1999)
Dietary Concentration (ppm):
		0,	50,	150,	500, 	1000	1500
Intake Dose (mg/kg/day):
	M:	0,	9.2,	30.4,	119.4, 	274.4,	475.5
	F:	0,	12.9,	40.4,	162.0, 	374.1, 	634.8
Acceptable / Guideline

NOAEL (mg/kg/day):	M =	9.2	F =	12.9
LOAEL (mg/kg/day):	M =	30.4	F =	40.4
Based on decreased body weights/body weight gains (males), changes in clinical chemistry (increased urea and decreased triglycerides), and increased incidences in females of lymph node apoptosis, thymus atropy, and ulcer/erosion in the glandular stomach.
                                   870.3150
90-Day Oral Toxicity in Non-Rodents (Dog)

45118323 (1999)
Dietary Concentration (ppm):
		0,	100,	200,	450
Intake Dose (mg/kg/day):
	M:	0,	2.8,	5.8,	12.9
	F:	0,	3.0,	6.2,	13.6
Acceptable / Guideline

NOAEL (mg/kg/day):	M =	5.8	F =	6.2
LOAEL (mg/kg/day):	M =	12.9	F =	13.6
Based on an increased incidence of diarrhea, clinical chemistry changes and mucosal hypertrophy of the duodenum (both sexes) and body weight loss, decreased food intake and decreased food efficiency (females only).
                                   870.3200
21/28-Day
Dermal Toxicity (Rabbit)

45118324 (1999)
Applied Dose (mg/kg/day):
	M:	0,	40,	100,	250
	F:	0,	40,	100,	250
Unacceptable / Guideline

Unacceptable due to the lack of systemic effects at the highest dose tested (250 mg/kg/day); the limit dose is 1000 mg/kg/day.

Dermal
NOAEL (mg/kg/day):	M =	40	F =	40
LOAEL (mg/kg/day):	M =	100	F =	100
Based on scale formation, hyperkeratosis, and epidermal thickening at the site of application.

Systemic
NOAEL (mg/kg/day):	M =	250	F =	250
LOAEL (mg/kg/day):	M >	250	F >	250

                                   870.3465
28-Day
Inhalation Toxicity
(Rat)

46638801 (2005)
Applied Dose (mg/L):
	M:	0,	0.001,	0.030,	0.300
	F:	0,	0.001,	0.030,	0.300
Acceptable / Guideline

NOAEL (mg/L):	M =	0.001	F =	0.001
LOAEL (mg/L):	M =	0.030	F =	0.030
Based on findings of hyperplasia in the duodenum, alveolar histiocytosis in the lungs, and olfactory atrophy/necrosis in the nasal tissues.
                                   870.3700
Prenatal Developmental Toxicity Study (Rat)
45118325 (1999)
Gavage Dose (mg/kg/day):
	F:	0,	10,	25,	50
Acceptable / Guideline
Maternal
NOAEL (mg/kg/day) =	10
LOAEL (mg/kg/day) =	25
Based on decreased body weights and body weight gains and reduced food consumption and reduced food efficiency.

Developmental
NOAEL (mg/kg/day) =	25
LOAEL (mg/kg/day) =	50
Based on increased incidence of dilated renal pelvis and cervical ribs.

Prenatal Developmental Toxicity Study (Rabbit)
45118326 (1999)
45437001 (2001)
Gavage Dose (mg/kg/day):
	F:	0,	1,	3,	5, 	10, 	20
Acceptable / Guideline

Maternal
NOAEL (mg/kg/day) =	5
LOAEL (mg/kg/day) =	10
Based on body weight gains, reduced food consumption and reduced food efficiency.

Developmental
NOAEL (mg/kg/day) =	5
LOAEL (mg/kg/day) =	10
Based on increased resorptions per litter, increased post-implantation loss and dams with total resorptions.

                                   870.3800
Reproduction and Fertility Effects
(Rat)
45118327 (1999)
Dietary Concentration (ppm):
		0,	25,	75,	300
Intake Dose (mg/kg/day):
	M0:	0,	2.5,	7.4,	29.0
	F0:	0,	2.6,	7.8,	30.4

	M1:	0,	2.8,	8.6,	35.0
	F1:	0,	3.0,	9.0,	36.0
Acceptable / Guideline

Parental
NOAEL (mg/kg/day):	M =	29.0	F =	30.4
LOAEL (mg/kg/day):	M >	29.0	F >	30.4

Reproductive
NOAEL (mg/kg/day):	M =	29.0	F =	30.4
LOAEL (mg/kg/day):	M >	29.0	F >	30.4

Offspring
NOAEL (mg/kg/day):	M =	29.0	F =	30.4
LOAEL (mg/kg/day):	M >	29.0	F >	30.4

45596210 (2002)
Dietary Concentration (ppm):
		0,	200,	400,	600
Intake Dose (mg/kg/day):
	M:	0,	20.5,	39.9,	59.1
	F:	0,	21.3,	42.5,	60.4
Acceptable / Non-Guideline

One-Generation Study
Parental
NOAEL (mg/kg/day):	M =	20.5	F =	42.5
LOAEL (mg/kg/day):	M =	39.9	F =	60.4
Based on reduced body weights and body weight gains.

Reproductive
NOAEL (mg/kg/day):	M <	20.5	F <	21.3
LOAEL (mg/kg/day):	M <=	20.5	F <=	21.3

Offspring
NOAEL (mg/kg/day):	M >=	59.1	F >=	60.4
LOAEL (mg/kg/day):	M >	59.1	F >	60.4
Based on a reduced pup body weights and body weight gains (a threshold body weight effect).

                                   870.4100
Chronic Toxicity (Rat)
45118329 (1999)
Dietary Concentration (ppm):
		0,	25,	75,	200
Intake Dose (mg/kg/day):
	M:	0,	1.1,	3.4,	9.0
	F:	0,	1.5,	4.6,	12.3
Unacceptable / Guideline

Unacceptable due to low dose selection

NOAEL (mg/kg/day):	M =	9.0	F =	12.3
LOAEL (mg/kg/day):	M >	9.0	F >	12.3

There was no evidence of carcinogenic potential

Chronic Toxicity (Dog)
45118328 (1999)
Dietary Concentration (ppm):
		0,	100,	200,	400
Intake Dose (mg/kg/day):
	M:	0,	2.7,	5.4,	10.8
	F:	0,	2.7,	5.4,	11.2
Acceptable / Guideline

NOAEL (mg/kg/day):	M =	5.4	F =	5.4
LOAEL (mg/kg/day):	M =	10.8	F =	11.2
Based on an increased incidence of diarrhea and clinical chemistry changes (both sexes) and decreased body weight gain, decreased food intake and decreased food efficiency (females only).
                                   870.4200
Carcinogenicity (Rat)

45118331 (1999)
Dietary Concentration (ppm):
		0,	25,	75,	200
Intake Dose (mg/kg/day):
	M:	0,	1.2,	3.4,	9.2
	F:	0,	1.5,	4.7,	12.6
Acceptable / Guideline

NOAEL (mg/kg/day):	M =	3.4	F =	4.7
LOAEL (mg/kg/day):	M =	9.2	F =	12.6
Based on differences in body weight and body weight gains, increased incidences of kidney tubular casts and atrophy in males and females, and in males, an increased incidence of necrosis of the liver, gross and microscopic evidence of erosion/ulcer of the glandular stomach and an increased incidence of acanthosis and ulcers of the forestomach.

Under the conditions of this study, there was no evidence of carcinogenic potential.

Carcinogenicity
(Mouse)
45118330 (1999)
Dietary Concentration (ppm):
	M:	0,	10,	30,	120
	F:	0,	10,	30,	120,	180
Intake Dose (mg/kg/day):
	M:	0,	1.4,	4.1,	17.2
	F:	0,	1.6,	4.8,	20.5,	32.8
Unacceptable / Guideline

Unacceptable due to low dose selection

NOAEL (mg/kg/day):	M >=	17.2	F >=	32.8
LOAEL (mg/kg/day):	M >	17.2	F >	32.8

Under the conditions of this study, there was no evidence of carcinogenic potential.

                                   870.5100
Bacterial Reverse Mutation Test
(Salmonella typhimurium)
45118332 (1997)
Applied Dose (ug/plate):
	S9:	0,	20,	100,	500,	2500,			5000
Acceptable / Guideline

+-S9: Negative up to 2500 μg/plate in the absence of cytotoxicity with precipitation above this concentration.

There was no evidence of treatment-induced mutant colonies above background levels.

                                   870.5300
in vitro Mammalian Cell Gene Mutation Test
(Mouse Lymphoma Cells)

45118335 (1998)
Applied Dose (ug/mL):
	S9: 	0.625,	1.25,	2.5,	5.0,	10.0,			20.0
	S9: 	3,	4,	5,	6,	7,			8
	S9: 	1.25,	2.5,	5.0,	10.0,	20.0
Acceptable / Guideline

BAS 500 F was tested up to cytotoxic and solubility limit concentrations. The positive controls induced the appropriate response. There was no evidence of induced mutant colonies over background.
                                   870.5375
in vitro Mammalian Chromosome Aberration Test
(Chinese Hamster Ovary cells)

45118333 (1999)
Applied Dose (ug/mL):
	S9: 	0,	6.25,	12.5,	25.0		+S9: 	0,	3.125,	6.25,	12.5
	S9: 	0,	0.005,	0.010,	0.050,	0.100
Acceptable / Guideline

BAS 500 F was tested up to preciptating concentrations.  Positive controls induced the appropriate response. There was no evidence of an increase in the number of structural or numerical chromosomal aberrations induced over background.  It is therefore concluded that BAS  500 F is not a clastogenic agent under the conditions of this study.

                                   870.5395
Mammalian Erythrocyte Micronucleus Test
(Mouse)

45118334 (1998)
Gavage Dose (mg/kg/day):
	M:	0,	75,	150,	300
	F:	0,	75,	150,	300
Acceptable / Guideline

There was no significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow at any dose level tested, at any time after treatment. It is therefore concluded that BAS 500 F did not induce a clastogenic effect in either sex at any sacrifice time.

                                   870.5550
Unscheduled DNA Synthesis in Mammalian Cells in Culture
(Rat Hepatocytes)

45118336 (1998)
Applied Dose (ug/mL):
	Run 1: 	0.01,	0.03,	0.1, 	0.3, 	1.0	Run 2: 	0.004,	0.02,	0.5
Acceptable / Guideline

BAS 500 F was tested up to cytotoxic concentrations. The positive controls induced the appropriate response.  There was no evidence that BAS 500 F induced unscheduled DNA synthesis, as determined by net nuclear silver grain counts.

                                   870.6200
Acute Neurotoxicity Screening Battery
(Rat)

45118337 (1999)
Gavage Dose (mg/kg/day):
	M:	0,	100,	300,	1000
	F:	0,	100,	300,	1000
Acceptable / Guideline

Neurotoxicity
NOAEL (mg/kg/day):	M =	1000	F =	1000
LOAEL (mg/kg/day):	M >	1000	F >	1000

Systemic
NOAEL (mg/kg/day):	M =	300	F =	1000
LOAEL (mg/kg/day):	M =	1000	F >	1000
For males, based on 33% decreased body weight gain (p  0.01) on days 0-7; no similar effect was detected on days 0-14.

90-Day Neurotoxicity Screening Battery
(Rat)
45118401 (1999)
Dietary Concentration (ppm):
		0,	50,	250,	M: 750
					F: 1500
Intake Dose (mg/kg/day):
	M:	0,	3.5,	16.9,	49.9
	F:	0,	4.0,	20.4,	111.9
Acceptable / Guideline

Neurotoxicity
NOAEL (mg/kg/day):	M =	49.9	F =	111.9
LOAEL (mg/kg/day):	M >	49.9	F >	111.9

Systemic
NOAEL (mg/kg/day):	M =	16.9	F =	20.4
LOAEL (mg/kg/day):	M =	49.9	F =	111.9
Based on decreased body weight gain, food intake and food efficiency (both sexes) and decreased water intake (males only).

                                   870.7485
Metabolism and Pharmacokinetics (Rat)
45118403 (1998)
45118404 (1999)
Gavage Dose (mg/kg):
	Single: 		5,	50
	Repeated: 	50
Acceptable / Guideline
Nearly 35% of an oral dose of pyraclostrobin is absorbed with urinary and fecal excretions accounting for about 15% and 85%, respectively, and bile elimination accounted for about 30%. Two peak plasma concentrations were reached at 0.5-1 and 8 hours with lower plasma concentrations in males than females (by 16-38%) during the early peak phase. Elimination was biphasic at a low dose with plasma half lives of nearly 10/35 hours and monophasic at a high dose with a half-life of nearly 20 hours.

Tissue distribution was fast, peaking at 0.5 hours, and was slightly higher among females. Some of the highest concentrations were found in the liver, thyroid, kidney, lung, adrenal glands, and pancreas but all levels dropped by more than 20-fold within 72 hours.

About 33 metabolites were identified in urine, feces, and bile with no sex- or dose-related differences but the position of the label seemed to alter the profile, particularly in the urine. Desmethoxy pyraclostrobin (500M07) is one of the major metabolites in rat and is also found in large amounts in plants (BF 500-3) and livestock (500M07). The rat metabolic pathway included phase-I reactions such as N-demethoxylation, various hydroxylations, and cleavage of the ether bond with subsequent oxidation; these reactions were followed by phase II glucuronidation and sulfation.

                                   870.7600
Dermal Penetration (Rat)

45118402 (1999)
Applied Dose (mg/cm[2]):
	M: 		0.015,	0.075,	0.375
Unacceptable / Guideline

Unacceptable because the actual dose was indeterminate due to material retained on the dressings being unavailable for absorption.

The HIARC calculated and recommended a dermal penetration rate of 14%. (TXR#0051553: 10 FEB 2003)

In all three doses the largest portion of the dose was found in the Dressings (72.38-84.36%, 78.51-81.58% and 76.38-80.24% for the respective doses) The dressings consisted of silicone ring, nylon mesh cover and porous bandage. This material must be considered unavailable for absorption.

Dermal penetration of [[14]C-tolyl]-pyraclostrobin was low for all dose groups and time intervals (0.44-2.60%). After an 8-hour exposure period, absorbed radioactivity accounted for 0.65%, 0.86% and 0.50% of the applied dose at nominal doses of 0.015, 0.075 and 0.375 mg/cm[2], respectively. After removal of the test substance and washing the site, absorption continued - an additional 0.93-1.74% of the dose in each dose group over the next 64 hours; however, there was no concomitant decrease in radioactivity in the skin.

The percent of the dose absorbed was not dose dependent; however, the actual amount of the test material absorbed did increase with increasing dose level. Immediately following the 8-hour exposure period, absorbed radioactivity accounted for 0.105, 0.757 and 2.27 ug/cm[2] at mean achieved doses of 0.017, 0.087 and 0.428 mg/cm[2]. Comparing the increases from the low to high-dose groups, the amount of actual absorption increased by 21.6x compared to the 25.2x increase in the dose level. This pattern of absorption is commonly seen with a chemical which directly damages the stratum corneum of the skin.

                                   870.7800
Immunotoxicity
(Mouse)

48830601 (1999)
Dietary Concentration (ppm):
		0,	50,	200,	750
Intake Dose (mg/kg/day):
	F:	0,	13,	50,	165
Unclassified

Preliminary review of the studies does not indicate any immunotoxicity or systemic toxicity below 165 mg/kg/day.

48830602 (2012)
Dietary Concentration (ppm):
		0,	50,	200,	750
Intake Dose (mg/kg/day):
	F:	0,	13,	50,	202
Unclassified

48830603 (2012)
Dietary Concentration (ppm):
		0,	50,	200,	750
Intake Dose (mg/kg/day):
	F:	0,	14,	55,	191
Unclassified

Appendix B.  Physicochemical Properties of Pyraclostrobin.

TABLE B.  Physicochemical Properties of Technical Grade Pyraclostrobin.
Parameter
                                     Value
                            References[1]  (MRID)
Melting point/range
63.7-65.2ºC
                                   45118213
pH
Not applicable

Density
1.367 g/cm[3]
                                   45118214
Water solubility at 20 ºC
1.9 +-  0.17 mg/L (deionized water, pH 5.8)

                                   45118233
Solvent solubility
n-heptane (0.37 g/100mL);  2-propanol (3.0 g/100mL); 1-octanol (2.42 g/100mL);  olive oil (2.80 g/100m/L);  methanol  (10.08 g/100mL); >50 g/100mL in acetone, ethyl acetate , acetonitrile, dichloromethane and toluene.
                                   45118228
Vapor pressure
2.6 x 10[-10] hPa at 20 ºC

                                   45118214
Dissociation constant, pKa
None (no dissociable moieties)

Octanol/water partition coefficient, Log(KOW) at room temperature
3.990 mean log Pow; Pow is 9772

                                   45118215
UV/visible absorption spectrum
The structural identity of BAS 500 F was confirmed by NMR and MS spectra. UV molecular extinction (e [1 mol[-1] cm[-1]]): 2.5x10[4] at 205 nm; 2.4x10[4] at 275 nm.
                                 1996/10955[2]
[1]	Product Chemistry data were reviewed by the Registration Division (DP# 269848 and DP# 274191, 5/3/01, 5/15/01, and 6/7/01, S. Malak).
[2]	BASF Document Number.

Appendix C.  Review of Human Research

The PHED Task Force, 1995.  The Pesticide Handlers Exposure Database, Version 1.1.  Electronic Database.  Task Force Members: Health Canada, U.S. EPA, and the National Agricultural Chemicals Associations, released February 1995.

The Agricultural Handler Exposure Task Force (AHETF), 2011. The Occupational Handler Unit Exposure Surrogate Reference Table.  U.S. EPA.  Released June 21, 2011.

Data from the Outdoor Residential Exposure Task Force (ORETF).

HED Residential Standard Operating Procedures (2012).

Appendix D.  Summaries of Field Residue Data

TABLE D-1.  Summary of Residue Data from Crop Field Trials with Pyraclostrobin on Sugarcane.
Commodity
                              Total Applic. Rate
                                   (lb ai/A)
                                  [kg ai/ha]
                                  PHI (days)
                                    Analyte
                               Residue Levels[1]
                                     (ppm)

                                       n
                                  SampleMin.
                                    Sample
                                     Max.
                                    LAFT[2]
                                    HAFT[2]
                                    Median
                                     Mean
                                   Std. Dev.
Sugarcane
                                   0.78-0.81
                                  (0.88-0.91)
                                     13-14
                                Pyraclostrobin
                                       8
                                   <0.02
                                    0.1049
                                   <0.02
                                     0.099
                                     0.058
                                   <0.060
                                     0.026

                                   BF 500-3
                                       8
                                   <0.02
                                    0.0267
                                   <0.02
                                     0.027
                                   <0.02
                                   <0.021
                                     0.002

                                   Combined
                                       8
                                   <0.04
                                   <0.125
                                   <0.040
                                   <0.119
                                   <0.076
                                   <0.076
                                     0.029

                                     27-28
                                Pyraclostrobin
                                       8
                                   <0.02
                                    0.0866
                                   <0.020
                                     0.068
                                     0.043
                                   <0.044
                                     0.016

                                   BF 500-3
                                       8
                                   <0.02
                                   <0.02
                                   <0.02
                                   <0.02
                                   <0.02
                                   <0.02
                                      N/A

                                   Combined
                                       8
                                   <0.04
                                  <0.1066
                                   <0.040
                                   <0.088
                                   <0.062
                                   <0.061
                                     0.017
Sugarcane
(for processing)
                                   3.94-3.99
                                  [4.42-4.47]
                                      14
                                Pyraclostrobin
                                       2
                                    0.0238
                                    0.2935
                                     0.028
                                     0.255
                                     0.141
                                     0.141
                                      N/A

                                   BF 500-3
                                       2
                                   <0.02
                                    0.0253
                                   <0.02
                                     0.025
                                   <0.022
                                   <0.022
                                      N/A

                                   Combined
                                       2
                                   <0.044
                                     0.319
                                   <0.048
                                     0.280
                                   <0.164
                                   <0.164
                                      N/A

                                      28
                                Pyraclostrobin
                                       2
                                    0.0203
                                   0.3811[3]
                                     0.026
                                     0.268
                                     0.147
                                     0.147
                                      N/A

                                   BF 500-3
                                       2
                                   <0.02
                                    0.0405
                                   <0.02
                                   <0.030
                                   <0.025
                                   <0.025
                                      N/A

                                   Combined
                                       2
                                   <0.040
                                     0.422
                                   <0.046
                                   <0.299
                                   <0.172
                                   <0.172
                                      N/A

TABLE D-2.  Summary of Residue Data from Globe Artichoke Crop Field Trials with Pyraclostrobin.
Commodity
                              Total Applic. Rate
                                   (lb ai/A)
                                  [kg ai/ha]
                                  PHI (days)
                                    Analyte
                               Residue Levels[1]
                                     (ppm)

                                       n
                                  SampleMin.
                                    Sample
                                     Max.
                                    LAFT[2]
                                    HAFT[2]
                                    Median
                                     Mean
                                   Std. Dev.
                             Artichoke Flower Head
                                  0.549-0.562
                                 (0.615-0.630)
                                       0
                                Pyraclostrobin
                                       3
                                     0.514
                                     1.110
                                     0.618
                                     1.045
                                     0.759
                                     0.807
                                     0.218

                                   BF 500-3
                                       3
                                   <0.02
                                     0.056
                                   <0.02
                                     0.056
                                   <0.028
                                   <0.035
                                     0.019

                                   Combined
                                       3
                                   <0.534
                                     1.166
                                   <0.638
                                     1.101
                                   <0.787
                                   <0.842
                                     0.236
[1]  Except for sample min/max, values reflect per trial averages; n = no. of field trials.  For calculation of median, mean, and standard deviation, the LLMV (0.02 ppm) was used for any results reported as <LLMV in Table C.3.
[2]  LAFT = lowest average field trial; HAFT = highest average field trial.

TABLE D-3.  Summary of Residue Data from Belgium Endive Crop Field Trials with Pyraclostrobin.
Commodity
                                    Rate[1]
                                  PHI (days)
                                    Analyte
                               Residue Levels[2]
                                     (ppm)

                                       n
                                  SampleMin.
                                    Sample
                                     Max.
                                    LAFT[3]
                                    HAFT[3]
                                    Median
                                     Mean
                                   Std. Dev.
            Treatment 02: One pre-cold-storage application to roots
Belgium endive heads
                       0.578-0.597 g ai/100 lb of roots
                                     25-27
                                Pyraclostrobin
                                       3
                                   <0.02
                                    0.0679
                                   <0.023
                                     0.059
                                   <0.040
                                   <0.041
                                     0.018

                                   BF 500-3
                                       3
                                   <0.02
                                   <0.02
                                   <0.02
                                   <0.02
                                   <0.02
                                   <0.02
                                      N/A

                                   Combined
                                       3
                                   <0.04
                                   <0.088
                                   <0.043
                                   <0.079
                                   <0.06
                                   <0.061
                                     0.018
      Treatment 03: One pre-forcing application to roots in packing tray
Belgium endive heads
                            0.089-0.097 g ai/ft[2]
                                     17-19
                                Pyraclostrobin
                                       3
                                    0.1239
                                    1.7620
                                     0.150
                                     1.347
                                     0.900
                                     0.799
                                     0.605

                                   BF 500-3
                                       3
                                   <0.02
                                   <0.02
                                   <0.02
                                   <0.02
                                   <0.02
                                   <0.02
                                      N/A

                                   Combined
                                       3
                                   <0.144
                                   <1.782
                                   <0.170
                                   <1.367
                                   <0.920
                                     0.819
                                     0.605
Treatment 04: One pre-cold-storage application to roots + One pre-forcing application to roots in packing tray
Belgium endive heads
                    0.584-0.591 g ai/100 lb of roots and[3]
                            0.092-0.101 g ai/ft[2]
                                     17-19
                                Pyraclostrobin
                                       3
                                    0.2250
                                    0.8710
                                     0.256
                                     0.771
                                     0.551
                                     0.526
                                     0.258

                                   BF 500-3
                                       3
                                   <0.02
                                   <0.02
                                   <0.02
                                   <0.02
                                   <0.02
                                   <0.02
                                      N/A

                                   Combined
                                       3
                                   <0.245
                                   <0.891
                                   <0.276
                                   <0.791
                                   <0.571
                                   <0.546
                                     0.258
[1]  Rate for pyraclostrobin, as calculated by the study reviewer based on the certificate of analysis of applied product in the study report.
[2]  Except for sample min/max, values reflect per trial averages; n = no. of field trials.  For calculation of median, mean, and standard deviation, the LLMV (0.02 ppm) was used for any results reported as <LLMV in Table C.3.  N/A = Not Applicable.
[3]  LAFT = lowest average field trial; HAFT = highest average field trial.

TABLE D-4.  Summary of Residue Data from Persimmon Crop Field Trials with Pyraclostrobin.
Commodity
                              Total Applic. Rate
                                   (lb ai/A)
                                  [kg ai/ha]
                                  PHI (days)
                                    Analyte
                               Residue Levels[1]
                                     (ppm)

                                       n
                                  SampleMin.
                                    Sample
                                     Max.
                                    LAFT[2]
                                    HAFT[2]
                                    Median
                                     Mean
                                   Std. Dev.
                                Persimmon Fruit
                                  0.564-0.573
                                 (0.632-0.642)
                                       0
                                Pyraclostrobin
                                       3
                                     0.421
                                     1.278
                                     0.092
                                     1.155
                                     0.437
                                     0.561
                                     0.542

                                   BF 500-3
                                       3
                                   <0.02
                                     0.077
                                   <0.02
                                     0.073
                                   <0.02
                                   <0.038
                                     0.031

                                   Combined
                                       3
                                   <0.103
                                     1.355
                                   <0.112
                                     1.228
                                   <0.457
                                   <0.599
                                     0.571
[1]  Except for sample min/max, values reflect per trial averages; n = no. of field trials.  For calculation of median, mean, and standard deviation, the LLMV (0.02 ppm) was used for any results reported as <LLMV in Table C.3.  N/A = Not Applicable.
[2]  LAFT = lowest average field trial; HAFT = highest average field trial.

Appendix E.  Summaries of Occupational Handler and Post-application Exposure and Risk Estimates

Table E-1.  Occupational Handler Non-Cancer Exposure and Risk Estimates for Pyraclostrobin.
                               Exposure Scenario
                                     Crop
                      Dermal Unit Exposure (μg/lb ai)[1]
                    Inhalation Unit Exposure (μg/lb ai)[1]
                                    Maximum
                              Application Rate[2]
                                   (lb ai/A)
                    Area Treated or Amount Handled Daily[3]
                                    Dermal
                                  Inhalation

                                   Baseline
                                   Baseline

                              Dose (mg/kg/day)[4]
                                    MOE[5]
                              Dose (mg/kg/day)[6]
                                    MOE[7]
                                 Mixer/Loader
                          Aerial applications of WDG
                                      and
                        Chemigation application of WDG
                                   Artichoke
                                   Persimmon
                                      227
                                     8.96
                                     0.18
                                      350
                                     0.029
                                      170
                                    0.0071
                                      33
                            Aerial applications of
                                      SC
                                   Sugarcane
                                      220
                                     0.219
                                     0.20
                                     1200
                                     0.11
                                      47
                                    0.00069
                                      350
                          Airblast application of WDG
                                   Persimmon
                                      227
                                     8.96
                                     0.18
                                      40
                                    0.0033
                                     1,500
                                    0.00081
                                      290
                        Chemigation application of WDG
                                      and
                         Groundboom application of WDG
                              Greenhouse tomatoes
                                      227
                                     8.96
                                     0.18
                                      60
                                    0.0050
                                     1,000
                                    0.0012
                                      190
                        Chemigation applications of SC
                                   Sugarcane
                                      220
                                     0.219
                                     0.20
                                      350
                                     0.031
                                      160
                                    0.00019
                                     1,200
                         Groundboom application of WDG
                                   Artichoke
                                      227
                                     8.96
                                     0.18
                                      80
                                    0.0066
                                      750
                                    0.0016
                                      140
                         Groundboom application of SC
                                   Sugarcane
                                      220
                                     0.219
                                     0.20
                                      200
                                     0.018
                                      280
                                    0.00011
                                     2,100
                                  Applicator
                              Aerial application
                                   Artichoke
                                   Persimmon
                                       5
                                     0.068
                                     0.18
                                      350
                                    0.00064
                                     7,800
                                   0.000054
                                     4,300
                              Aerial application
                                   Sugarcane
                                       5
                                     0.068
                                     0.20
                                     1200
                                    0.0024
                                     2,100
                                    0.00020
                                     1,100
                             Airblast application
                                   Persimmon
                                     1770
                                     4.71
                                     0.18
                                      40
                                     0.026
                                      190
                                    0.00042
                                      540
                            Groundboom application
                              Greenhouse tomatoes
                                     78.6
                                     0.34
                                     0.18
                                      60
                                    0.0017
                                     2,900
                                   0.000046
                                     5,000
                            Groundboom application
                                   Artichoke
                                     78.6
                                     0.34
                                     0.18
                                      80
                                    0.0023
                                     2,200
                                   0.000071
                                     3,200
                            Groundboom application
                                   Sugarcane
                                     78.6
                                     0.34
                                     0.20
                                      200
                                    0.0064
                                      780
                                    0.00017
                                     1,400
                                    Flagger
                                    Flagger
                                   Artichoke
                                   Persimmon
                                      11
                                     0.35
                                     0.18
                                      350
                                    0.0014
                                     3,500
                                    0.00028
                                      830
                                    Flagger
                                   Sugarcane
                                      11
                                     0.35
                                     0.20
                                      350
                                    0.0016
                                     3,200
                                    0.00031
                                      750
                            Mixer/Loader/Applicator
                          Backpack application of WDG
                              Greenhouse tomatoes
                                    13,200
                                      140
                                    0.0018
                                   lb ai/gal
                                      40
                                      gal
                                    0.0019
                                     2,600
                                    0.00013
                                     1,800
                   Manually pressurized handwand app of WDG
                              Greenhouse tomatoes
                                    100,000
                                      30
                                    0.0018
                                   lb ai/gal
                                      40
                                      gal
                                     0.015
                                      340
                                   0.000027
                                     8,500
                    Mechanically pressurized handgun of WDG
                                   Artichoke
                                   Persimmon
                                     1300
                                      3.9
                                    0.0018
                                   lb ai/gal
                                     1000
                                      gal
                                    0.0048
                                     1,100
                                    0.00088
                                     2,600
                    Mechanically pressurized handgun of WDG
                              Greenhouse tomatoes
                                     3500
                                      120
                                    0.0018
                                   lb ai/gal
                                     1000
                                      gal
                                     0.013
                                      390
                                    0.0027
                                      85
                    Mechanically pressurized handgun of WDG
                   Belgium Endive  -  prior to cold storage
                                     1300
                                      3.9
                                   0.000014
                                lb ai/ lb root
                                    200,000
                                    lb root
                                    0.0074
                                      680
                                    0.00014
                                     1,700
                    Mechanically pressurized handgun of WDG
                      Belgium Endive  -  prior to forcing
                                     1300
                                      3.9
                                    0.0002
                                  lb ai/ft[2]
                                    10,890
                                     ft[2]
                                    0.0057
                                      870
                                    0.00011
                                     2,200

1	Based on the "Occupational Pesticide Handler Unit Exposure Surrogate Reference Table" (March 2013);
2	Based on proposed label (See Table 4).
3	Exposure Science Advisory Council Policy #9.1.
4	Dermal Dose = Dermal Unit Exposure (μg/lb ai) x Conversion Factor (0.001 mg/μg) x Application Rate (lb ai/acre or gal) x Area Treated or Amount  Handled Daily (A or gal/day) x DAF (%) / BW (kg).
5	Dermal MOE = Dermal NOAEL (mg/kg/day) / Dermal Dose (mg/kg/day).
6	Inhalation Dose = Dermal Unit Exposure (μg/lb ai) x Conversion Factor (0.001 mg/μg) x Application Rate (lb ai/acre or gal) x Area Treated or Amount  Handled Daily (A or gal/day) / BW (kg).
7	Inhalation MOE = Inhalation NOAEL (mg/kg/day) / Inhalation Dose (mg/kg/day).

Table E-2.  Occupational Handler Non-Cancer Exposure and Risk Estimates for Pyraclostrobin with PPE.
                               Exposure Scenario
                                     Crop
                      Dermal Unit Exposure (μg/lb ai)[1]
                    Inhalation Unit Exposure (μg/lb ai)[1]
                                    Maximum
                              Application Rate[2]
                                   (lb ai/A)
                    Area Treated or Amount Handled Daily[3]
                                    Dermal
                                  Inhalation

                               Baseline + gloves
                                PF5 Respirator

                              Dose (mg/kg/day)[4]
                                    MOE[5]
                              Dose (mg/kg/day)[6]
                                    MOE[7]
                                 Mixer/Loader
                          Aerial applications of WDG
                                      and
                        Chemigation application of WDG
                                   Artichoke
                                   Persimmon
                                     51.6
                                     1.792
                                     0.18
                                      350
                                    0.0066
                                      760
                                    0.0014
                                      160
                            Aerial applications of
                                      SC
                                   Sugarcane
                                     37.6
                                    0.0438
                                     0.20
                                     1200
                                     0.018
                                      270
                                    0.00013
                                     1,800
                            Mixer/Loader/Applicator
                    Mechanically pressurized handgun of WDG
                              Greenhouse tomatoes
                                     2500
                                      24
                                    0.0018
                                   lb ai/gal
                                     1000
                                      gal
                                    0.0091
                                      550
                                    0.00054
                                      430
1	Based on the "Occupational Pesticide Handler Unit Exposure Surrogate Reference Table" (March 2013);
2	Based on proposed label (See Table 4).
3	Exposure Science Advisory Council Policy #9.1.
4	Dermal Dose = Dermal Unit Exposure (μg/lb ai) x Conversion Factor (0.001 mg/μg) x Application Rate (lb ai/acre or gal) x Area Treated or Amount  Handled Daily (A or gal/day) x DAF (%) / BW (kg).
5	Dermal MOE = Dermal NOAEL (mg/kg/day) / Dermal Dose (mg/kg/day).
6	Inhalation Dose = Dermal Unit Exposure (μg/lb ai) x Conversion Factor (0.001 mg/μg) x Application Rate (lb ai/acre or gal) x Area Treated or Amount  Handled Daily (A or gal/day) / BW (kg).
7	Inhalation MOE = Inhalation NOAEL (mg/kg/day) / Inhalation Dose (mg/kg/day).

Table E-3.  Occupational Post-application Non-Cancer Exposure and Risk Estimates for Pyraclostrobin.
                                   Crop/Site
                                  Activities
                        Transfer Coefficient (cm[2]/hr)
                                    DFR[1]
                                 Dermal Dose
                                (mg/kg/day)[2]
                                    MOE[3]
                                   Sugarcane
                                   Scouting
                                     1,100
                                     0.152
                                    0.0027
                                     1,800

                                Hand Harvesting
                                    17,600

                                     0.043
                                      120

                                 Hand Weeding
                                      70

                                    0.00017
                                    29,000
                                   Artichoke
                                Hand Harvesting
                                     1,100
                                     0.379
                                    0.0068
                                      740

                        Hand Weeding, Thinning, Pruning
                                      70

                                    0.00043
                                    12,000

                                  Irrigation
                                  (hand set)
                                     1,900

                                     0.012
                                      430

                                   Scouting
                                      210

                                    0.0013
                                     3,900

                                 Transplanting
                                      230

                                    0.0014
                                     3,500
                                   Persimmon
                       Scouting, Hand pruning, Training
                                      580
                                     0.686
                                    0.0065
                                      770

                  Hand weeding, Propping, orchard maintenance
                                      100

                                    0.0011
                                     4,500

                                Hand Harvesting
                                     1,400

                                     0.016
                                      320

                                 Transplanting
                                      230

                                    0.0026
                                     2,000

                                   Thinning
                                     3,600

                                     0.040
                                      120
                              Greenhouse Tomatoes
Hand harvesting, pinching, hand pruning, Scouting, Turning, Tying, Hand weeding,
                                     1200
                                     0.379
                                    0.0074
                                      680

                   Irrigation (hand watering), Transplanting
                                      230

                                    0.0014
                                     3,500
1	DFR chemical-specific study (see Appendix D, Tables D4, D5, and D6)
2	Daily Dermal Dose = [DFR (ug/cm[2]) x Transfer Coefficient x 0.001 mg/ug x 8 hrs/day x dermal absorption (%)]  BW (kg).
3	MOE = POD (mg/kg/day) / Daily Dermal Dose.  Daily Dermal Dose = [DFR (ug/cm[2]) x TC x 0.001 mg/ug x 8 hrs/day x dermal absorption factor (%)]  BW (kg).

Appendix F. Summary of Pyraclostrobin DFR Study Results

Table F-1. Summary of DFR Values and Regression Analysis Results for Treated Peach Foliage with Pyraclostrobin
                                Input/Parameter
                                    Georgia
                                 Pennsylvania
                                  California
Application Rate (lb ai/A)
 (Study Target Rate = 0.12 lb ai/A)
                                     0.12
                                     0.12
                                     0.12
Spray Volume (GPA)
                                      105
                                     92.2
                                      152
Measured Average Day 0 Residue (ug/cm[2])
                                     0.175
                                     0.29
                                     0.29
Predicted Day 0 Residue (ug/cm[2])
                                     0.176
                                     0.457
                                     0.389
Slope
                                    -0.0963
                                    -0.105
                                    -0.0297
Half-life (days)
                                      7.2
                                      6.6
                                      23
R[2]
                                     0.98
                                     0.90
                                     0.59

Table F-2. Summary of DFR Values and Regression Analysis Results for Treated Strawberry Foliage with Pyraclostrobin
                                Input/Parameter
                                North Carolina
                                  California
                                    Oregon
Application Rate (lb ai/A)
 (Study Target Rate = 0.18 lb ai/A)
                                     0.18
                                     0.18
                                     0.18
Spray Volume (GPA)
                                     45.8
                                     45.8
                                     45.8
Measured Average Day 0 Residue (ug/cm[2])
                                     0.505
                                     0.431
                                     0.19
Predicted Day 0 Residue (ug/cm[2])
                                      0.1
                                     0.379
                                    0.0963
Slope
                                    -0.139
                                    -0.166
                                    -0.106
Half-life (days)
                                       5
                                      4.2
                                      6.5
R[2]
                                     0.62
                                     0.99
                                     0.85

Table F-3. Summary of DFR Values and Regression Analysis Results for Treated Peanut Foliage with Pyraclostrobin
                                Input/Parameter
                                     Texas
                                    Georgia
                                North Carolina
Application Rate (lb ai/A)
 (Study Target Rate = 0.25 lb ai/A)
                                     0.25
                                     0.25
                                     0.25
Spray Volume (GPA)
                                 Not provided
                                 Not provided
                                 Not provided
Measured Average Day 0 Residue (ug/cm[2])
                                     0.497
                                     0.438
                                     0.511
Predicted Day 0 Residue (ug/cm[2])
                                     0.19
                                     0.104
                                     0.133
Slope
                                    -0.122
                                    -0.104
                                    -0.112
Half-life (days)
                                      5.7
                                      6.7
                                      6.2
R[2]
                                     0.78
                                     0.46
                                     0.63
Note: Bolded text indicates DFR values used in exposure assessments.

Appendix G.  International Residue Limits Status Sheet

                      Pyraclostrobin (099100; 02/19/2013)
Summary of US and International Tolerances and Maximum Residue Limits
Residue Definition:
US
Canada
Mexico[2]
Codex[3]
40 CFR §180.582.  Plants:  Tolerances are established for residues of the fungicide pyraclostrobin, including its metabolites and degradates.  Compliance with the tolerance levels is to be determined by measuring on the sum of pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H- pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite (methyl N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl carbamate), calculated as the stoichiometric equivalent of pyraclostrobin.
methyl [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxycarbamate, including the metabolite [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]carbamate
-
Pyraclostrobin.  Residue is NOT fat soluble.
Commodity[1]
Tolerance (ppm) /Maximum Residue Limit (ppm)

                                      US
Canada
Mexico[2]
Codex[3]
Artichoke, globe
                                      3.0
                                     None

2.
Belgium endive
(witloof chicory)
                                      4.0
                                     None

None
Persimmon
                                      3.0
                                     None

None
Vegetable, bulb, group 3-07
                                      0.9
                                      0.9

Garlic 0.15
Leek 0.7
Bulb onion 1.5
Spring onion 1.5
Vegetable, fruiting, group 8-10
                                      1.4
                                   Tomato 1
                                   Pepper 1

Tomato 0.3
Pepper 0.5
Eggplant (aubergine) 0.3
Fruit, citrus, group 10-10
                                      2.0
                                      2.0

2
Fruit, pome, group 11-10
                                      1.5
                                      1.5

Apple 0.5
Oilseed group 20
                                     0.45
                                     0.45

0.4
Caneberry subgroup 13-07A
                                      4.0
                                      3.5

Blackberry 3
Bushberry subgroup 13-07B
                                      4.0
                                      3.5

Blueberry 4
Small fruit, vine climbing subgroup (except fuzzy kiwi) 13-07F
                                      2.0
                                      2.0

Grape 2
Low growing berry subgroup 13-07G except cranberry
                                      1.2
                                      1.2

Strawberry 1.5
[1] Includes only commodities of interest for this action.  Tolerance values should be the HED recommendations and not those proposed by the applicant.
2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

3 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains.  PoP = processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.


[Federal Register Volume 80, Number 109 (Monday, June 8, 2015)]
[Rules and Regulations]
[Pages 32294-32297]
[FR Doc No: 2015-13355]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0464; Directorate Identifier 2014-SW-002-AD;
Amendment 39-18169; AD 2015-11-06]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters (Previously
Eurocopter France) Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are superseding Airworthiness Directive (AD) 2013-18-01 for
Eurocopter France Model EC 155B, EC155B1, SA-365N, SA-365N1, AS-365N2,
AS 365 N3, and SA-366G1 helicopters. AD 2013-18-01 required inspecting
the collective pitch lever for correct locking and unlocking
conditions. As published, AD 2013-18-01 contained certain errors. This
new AD retains the requirements of AD 2013-18-01, corrects the errors,
and updates the type certificate holder's name. The actions in this AD
are intended to detect an incorrectly adjusted collective pitch lever,
which

could result in loss of control of the helicopter.

DATES: This AD is effective July 13, 2015.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of October 18,
2013 (78 FR 56599, September 13, 2013).

ADDRESSES: For service information identified in this AD, contact
Airbus Helicopters, Inc., 2701 N. Forum Drive, Grand Prairie, Texas
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>;
or at http://www.airbushelicopters.com/techpub. You may view this
referenced service information at the FAA, Office of the Regional
Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas 76137. It is also available on the Internet at http://www.regulations.gov in Docket No. FAA-2014-0464.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0464; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the European Aviation Safety Agency (EASA) AD, any
incorporated-by-reference information, the economic evaluation, any
comments received, and other information. The address for the Docket
Office (phone:<PHONE_NUMBER>) is Document Management Facility, U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC
20590.

FOR FURTHER INFORMATION CONTACT: Matt Wilbanks, Aviation Safety
Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA,
2601 Meacham Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to remove AD 2013-18-01, Amendment 39-17574 (78 FR 56599,
September, 13, 2013) and add a new AD. AD 2013-18-01 applied to
Eurocopter France Model EC 155B, EC155B1, SA-365N, SA-365N1, AS-365N2,
AS 365 N3, and SA-366G1 helicopters, except helicopters with
modification (MOD) 0767B5 installed. AD 2013-18-01 required inspecting
the collective pitch lever for correct unlocking with a spring scale,
and if required, adjusting the collective pitch lever restraining tab
and, for certain models, adjusting the collective link rods. AD 2013-
18-01 also required inspecting the collective pitch lever for the risk
of inadvertent locking by measuring the clearance between the locking
pin of the collective pitch lever and the L-section of the restraining
tab, and if required, modifying the tab with a slight bend to the tab.
As published, the AD number after the amendatory language section of AD
2013-18-01 is incorrect. The AD number was published as ``2013-18-11.''
The MOD number in paragraph (a), Applicability, of the AD is also
incorrect. The correct MOD number is 0767B65. Also, since we issued AD
2013-18-01, the type certificate holder's name for the affected models
changed from Eurocopter France to Airbus Helicopters.
    AD 2013-18-01 was prompted by AD No. 2011-0154, dated August 22,
2011, issued by EASA, which is the Technical Agent for the Member
States of the European Union, to correct an unsafe condition for
Eurocopter Model EC 155B, EC155B1, SA-365N, SA-365N1, AS-365N2, AS 365
N3, and SA-366G1 helicopters. EASA advises of two occurrences of
inadvertent locking and unlocking of the collective pitch lever. One
inadvertent collective pitch lever locking occurred when moving the
collective pitch lever to the low-pitch position, and one inadvertent
collective pitch lever unlocking occurred during engine start. To
address this unsafe condition, EASA AD No. 2011-0154 requires
inspecting the collective pitch lever for correct locking and unlocking
conditions, except for those helicopters with a hinged, spring-loaded
collective lever locking blade installed, designated as MOD 0767B65.
    The NPRM published in the Federal Register on July 16, 2014 (79 FR
41466). The NPRM proposed to continue to require all of the inspection
and adjustment requirements of AD 2013-18-01. The NPRM also proposed to
correct the MOD number in paragraph (a) and reflect the current type
certificate holder's name and contact information. Removing AD 2013-18-
01 and issuing a new AD would also remove the incorrect AD number after
the amendatory language. The NPRM proposed no other changes to other
parts of the regulatory information.

Comments

    We gave the public the opportunity to participate in developing
this AD, but we did not receive any comments on the NPRM (79 FR 41466,
July 16, 2014).

FAA's Determination

    These helicopters have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, its technical
representative, has notified us of the unsafe condition described in
the EASA AD. We are issuing this AD because we evaluated all
information provided by EASA and determined the unsafe condition exists
and is likely to exist or develop on other helicopters of these same
type designs and that air safety and the public interest require
adopting the AD requirements as proposed.

Related Service Information Under 1 CFR Part 51

    We reviewed Eurocopter (now Airbus Helicopters) Alert Service
Bulletin (ASB) No. 67.00.10 for Model AS365 helicopters, ASB No. 67.05
for Model SA366 helicopters, and ASB No. 67A007 for Model EC155
helicopters. All three ASBs are Revision 1 and are dated February 25,
2009. These ASBs describe procedures for inspecting and adjusting the
collective pitch lever for correct locking and unlocking conditions.
This service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section of this AD.

Other Related Service Information

    Eurocopter also issued ASB No. 67.00.12, Revision 0, dated February
25, 2009, for Model AS365 helicopters; ASB No. 67.07, Revision 0, dated
February 25, 2009, for Model AS366 helicopters; and ASB No. 67-009,
Revision 1, dated July 19, 2010, for Model EC 155 helicopters. These
ASBs contain the procedures for MOD 0767B65.

Costs of Compliance

    We estimate that this AD will affect 32 helicopters of U.S.
Registry. We estimate that operators may incur the following costs in
order to comply with this AD. Inspecting and adjusting the collective
pitch lever requires about 1 work-hour at an average labor rate of $85
per work-hour, for a total cost per helicopter of $85 and a cost to
U.S. operators of $2,720.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more

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

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2013-18-01, Amendment 39-17574 (78 FR 56599, September 13, 2013), and
adding the following new AD:

2015-11-06 Airbus Helicopters (Previously Eurocopter France):
Amendment 39-18169; Docket No. FAA-2014-0464; Directorate Identifier
2014-SW-002-AD.

(a) Applicability

    This AD applies to Model EC 155B, EC155B1, SA-365N, SA-365N1,
AS-365N2, AS 365 N3, and SA-366G1 helicopters, except helicopters
with modification (MOD) 0767B65 installed, certificated in any
category.

(b) Unsafe Condition

    This AD defines the unsafe condition as inadvertent locking and
unlocking of the collective pitch lever, which could result in
subsequent loss of control of the helicopter.

(c) Affected ADs

    This AD supersedes AD 2013-18-01, Amendment 39-17574 (78 FR
56599, September 13, 2013).

(d) Effective Date

    This AD becomes effective July 13, 2015.

(e) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(f) Required Actions

    Within 50 hours time-in-service:
    (1) For Model EC 155B and EC155B1 helicopters:
    (i) Lock the collective pitch lever, and using a spring scale,
measure the load (G) required to unlock the pilot's collective pitch
lever as depicted in Figure 1, Detail B of Eurocopter Alert Service
Bulletin (ASB) No. 67A007, Revision 1, dated February 25, 2009 (ASB
67A007).
    (ii) If the collective pitch lever unlocks at a load less than
11 deca Newtons (daN) (24.7 lbs) or greater than 14 daN (31.5 lbs),
before further flight, adjust the collective pitch lever restraining
tab (F) using the oblong holes.
    (iii) Set the collective pitch lever to the ``low pitch''
position and hold it in this position, without forcing it downwards.
    (iv) Measure the clearance (J1) between the locking pin of the
collective pitch lever (C) and the L-section of the restraining tab
(F) as depicted in Figure 1, Detail A of ASB 67A007.
    (v) If the clearance between the locking pin of the collective
pitch lever and the L-section of the restraining tab is less than 3
millimeters (mm), before further flight, remove the restraining tab,
clamp the restraining tab (F) in a vice with soft jaws, and
gradually apply a load (H) to ensure a clearance of 3 mm or more, as
depicted in Figure 1, Detail K of ASB 67A007.
    (2) For Model SA-365N, SA-365N1, AS-365N2, and AS 365 N3
helicopters:
    (i) Completely loosen the friction, lock the collective pitch
lever, and using a spring scale, measure the load (G) required to
unlock the pilot's collective pitch lever as depicted in Figure 1,
Detail B of Eurocopter ASB No. 67.00.10, Revision 1, dated February
25, 2009 (ASB 67.00.10).
    (ii) If the collective pitch lever unlocks at a load less than 5
daN (11.3 lbs) or greater than 14 daN (31.5 lbs), before further
flight, adjust the collective pitch lever restraining tab (F) using
the oblong holes and adjust the collective link rods as described in
the Accomplishment Instructions, paragraph 2.B.4., of ASB 67.00.10.
    (iii) Set the collective pitch lever to the ``low pitch''
position and hold it in this position, without forcing it downwards.
    (iv) Tighten the friction lock and measure the clearance (J1)
between the locking pin of the collective pitch lever (C) and the L-
section of the restraining tab (F) as depicted in Figure 1, Detail A
of ASB 67.00.10.
    (v) If the clearance between the locking pin of the collective
pitch lever and the L-section of the restraining tab is less than 3
mm, before further flight, remove the restraining tab, clamp the
restraining tab (F) in a vice with soft jaws, and gradually apply a
load (H) to ensure a clearance of 3 mm or more, as depicted in
Figure 1, Detail K, of ASB 67.00.10.
    (3) For Model SA-366G1 helicopters:
    (i) Completely loosen the friction, lock the collective pitch
lever, and using a spring scale, measure the load (G) required to
unlock the pilot's collective pitch lever as depicted in Figure 1,
Detail B of Eurocopter ASB No. 67.05, Revision 1, dated February 25,
2009 (ASB 67.05).
    (ii) If the collective pitch lever unlocks at a load less than 5
daN (11.3 lbs) or greater than 14 daN (31.5 lbs), before further
flight, adjust the collective pitch lever restraining tab (F) using
the oblong holes and adjust the collective link rods as described in
the Accomplishment Instructions, paragraph 2.B.4., of ASB 67.05.
    (iii) Set the collective pitch lever to the ``low pitch''
position and hold it in this position, without forcing it downwards.
    (iv) Tighten the friction lock and measure the clearance (J1)
between the locking pin of the collective pitch lever (C) and the L-
section of the restraining tab (F) as depicted in Figure 1, Detail
A, of ASB 67.05.
    (v) If the clearance between the locking pin of the collective
pitch lever and the L-section of the restraining tab is less than 3
mm, before further flight, remove the restraining tab, clamp the
restraining tab (F) in a vice with soft jaws, and gradually apply a
load (H) to ensure a clearance of 3 mm or more, as depicted in
Figure 1, Detail K, of ASB 67.05.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Matt Wilbanks, Aviation Safety
Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA,
2601 Meacham Blvd., Fort Worth, Texas 76137; telephone (817) 222-
5110; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(h) Additional Information

    (1) Eurocopter Alert Service Bulletin (ASB) No. 67.00.12,
Revision 0, dated February 25, 2009; ASB No. 67.07, Revision 0,
dated February 25, 2009; and ASB No. 67-009, Revision 1, dated July
19, 2010, which are not incorporated by reference, contain
additional information about this AD. For service information
identified in this AD, contact Airbus Helicopters, Inc., 2701 N.
Forum Drive, Grand Prairie, Texas 75052; telephone<PHONE_NUMBER> or
(800) 232-0323; fax<PHONE_NUMBER>; or at http://www.airbushelicopters.com/techpub. You may review a copy of the
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas
76137.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency (EASA) AD No. 2011-0154, dated August 22, 2011. You
may view the EASA AD on the Internet at http://www.regulations.gov
in Docket No. FAA-2014-0464.

(i) Subject

    Joint Aircraft Service Component (JASC) Code: 6710, Main Rotor
Control.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (3) The following service information was approved for IBR on
October 18, 2013, (78 FR 56599, September 13, 2013).
    (i) Eurocopter Alert Service Bulletin No. 67.00.10, Revision 1,
dated February 25, 2009.
    (ii) Eurocopter Alert Service Bulletin No. 67.05, Revision 1,
dated February 25, 2009.
    (iii) Eurocopter Alert Service Bulletin No. 67A007, Revision 1,
dated February 25, 2009.
    (4) For Eurocopter service information identified in this AD,
contact Airbus Helicopters, Inc., 2701 N. Forum Drive, Grand
Prairie, Texas 75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>;
fax<PHONE_NUMBER>; or at http://www.airbushelicopters.com/techpub.
    (5) You may view this service information at FAA, Office of the
Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663,
Fort Worth, Texas 76137. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (6) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Fort Worth, Texas, on May 26, 2015.
Lance T. Gant,
Acting Directorate Manager, Rotorcraft Directorate, Aircraft
Certification Service.
[FR Doc. 2015-13355 Filed 6-5-15; 8:45 am]
 BILLING CODE 4910-13-P