Norflurazon Focus Meeting Contact Sheet  	4/11/13 meeting with Syngenta Name Organization Email Harold Coble USDA <EMAIL_ADDRESS>Khue Nguyen OPP/PRD <EMAIL_ADDRESS>Natalia Peranginangin Syngenta <EMAIL_ADDRESS>Richard Brain Syngenta <EMAIL_ADDRESS>Tracy White OPP/RD <EMAIL_ADDRESS>Mark Corbin OPP/EFED <EMAIL_ADDRESS>Brian Kiernan OPP/EFED <EMAIL_ADDRESS>Ibrahim Abdel-Saheb OPP/EFED <EMAIL_ADDRESS>Jihad Alsadek OPP BEAD <EMAIL_ADDRESS>Ana Rivera-Lupianez OPP/HED <EMAIL_ADDRESS>William Donovan OPP/HED <EMAIL_ADDRESS>Sunil Ratnayake OPP/BEAD <EMAIL_ADDRESS>Jerry Wells Syngenta <EMAIL_ADDRESS>Jeff Perine Syngenta <EMAIL_ADDRESS>Jisu Bang Syngenta <EMAIL_ADDRESS>Les Glasgow Syngenta <EMAIL_ADDRESS>Dan Campbell Syngenta <EMAIL_ADDRESS>Neil Anderson OPP/PRD <EMAIL_ADDRESS>Mike Metzger OPP/HED <EMAIL_ADDRESS>Michael Goodis OPP/PRD <EMAIL_ADDRESS>Tom Moriarty OPP/PRD <EMAIL_ADDRESS>


---
                                    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 Boscalid

Table A.2.1.  Acute Toxicity Profile  -  Boscalid (BAS 510 F) Technical

                                 Test Material

                                     GDLN

                                  Study Type

                                     MRID

                                    Results

                                      Tox
                                   Category

                                   Technical

                                   870.1100

                               Acute Oral - rat

                                   45404814

                             LD50 > 5000 mg/kg

                                      IV

                                   Technical

                                   870.1200

                              Acute Dermal - rat

                                   45404815

                             LD50 > 2000 mg/kg

                                      III

                                   Technical

                                   870.1300

                               Acute Inhalation

                                   45404816

                        LC50 (M & F): > 6.7 mg/L

                                      IV

                                   Technical

                                   870.2400

                            Primary Eye Irritation

                                   45404817

                           Not irritating to the eye

                                      IV

                                   Technical

                                   870.2500

                           Primary Dermal Irritation

                                   45404818

                          Not irritating to the skin

                                      IV

                                   Technical

                                   870.2600

                             Dermal Sensitization

                                   45404819

              Study unacceptable as challenge dose was inadequate

                                      N/A

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

  Table A.2 Repeated Dose Toxicity Profile of Boscalid (BAS 510 F) Technical.

                                 Guideline No.

                                  Study Type

                                    Results

870.3100

90-Day oral toxicity rodents (rats)

NOAEL: 34/159 mg/kg/day (M/F)
LOAEL: 137/395 mg/kg/day (M/F): M = increases in absolute and relative thyroid weights and increased incidence of thyroid hyperplasia as well as follicular epithelial hypertrophy; F = increases in absolute and relative thyroid weights.

870.3100

90-Day oral toxicity rodents (mice)

NOAEL: 197/2209 mg/kg/day (M/F)
LOAEL: 788/2209 mg/kg/day (M/F): M = increased liver weights and increased incidence of marked fatty change in the liver; F = not attained

870.3150

90-Day oral toxicity in nonrodents (dogs)

NOAEL: 7.6/8.1 mg/kg/day (M/F)
LOAEL: 78.1/81.7 mg/kg/day (M/F): M = increased alkaline phosphatase activity and hepatic weights; F = increased alkaline phosphatase activity and hepatic weights.

870.3200

21/28-Day dermal toxicity
(rats)

NOAEL: 1000 mg/kg/day (HDT)
LOAEL: >1000 mg/kg/day

870.3700

Prenatal developmental in rodents (rats)

Maternal NOAEL: 1000 mg/kg/day
Maternal LOAEL: cannot be established
Developmental NOAEL: 1000 mg/kg/day
Developmental LOAEL: cannot be established

870.3700

Prenatal developmental in nonrodents (rabbit)

Maternal NOAEL: 300 mg/kg/day
Maternal LOAEL: 1000 mg/kg/day based on abortions or early delivery.
Developmental NOAEL: 300 mg/kg/day
Developmental LOAEL: 1000 mg/kg/day based on abortions or early delivery.

870.3800

Reproduction and fertility effects (rat)

Parental systemic NOAEL:112.6/1180.8 mg/kg/day (M/F)
Parental systemic LOAEL:1165.0/>1180.8 mg/kg/day (M/F) decreased body weight and body weight gain (F1) as well as hepatocyte degeneration F0 and F1) in males only.
Offspring systemic NOAEL:11.2/115.8 mg/kg/day (M/F)
Offspring systemic LOAEL:112.6/1180.8 mg/kg/day (M/F): decreased body weight for F2 pups in males and females of both generations.
Reproductive NOAEL:1165.0/1180.8 mg/kg/day (M/F)
Reproductive LOAEL:>1165.0/1180.8 (M/F)

870.4100a

Chronic toxicity rodents (rat)

NOAEL: 21.9/30.0 mg/kg/day (M/F)
LOAEL: 110.0/150.3 mg/kg/day (M/F): M = thyroid toxicity (weights and microscopic changes); F = thyroid toxicity (weights and microscopic changes). Thyroid follicular cell adenomas: M = 0/20, 0/20, 2/20,1/20; F = 0/20, 0/20, 1/20,0/20.

870.4100

Chronic toxicity dogs

NOAEL: 21.8/22.1mg/kg/day (M/F)
LOAEL:57.4/58.3 mg/kg/day (M/F): M = elevated ALP activities and elevated hepatic weights; F = no effects

870.4200

Carcinogenicity rats

NOAEL: 23.0/29.7 mg/kg/day (M/F)
LOAEL: 116.1/155.6 mg/kg/day (M/F): M = increased incidence of thyroid follicular cell hyperplasia and hypertrophy; F = decrease in body weight gain and increased incidence of thyroid follicular cell hyperplasia and hypertrophy.  Thyroid follicular cell adenomas: M = 0/50, 0/50, 1/50, 4/50; F = 0/50, 1/50, 0/50, 3/50.

870.4200

Carcinogenicity mice

NOAEL:65/443 mg/kg/day (M/F)
LOAEL: 331/1804 mg/kg/day (M/F): M = decreases in body weight and body weight gains; F = decreases in body weight and body weight gains. No evidence of carcinogenicity.

870.4300

Chronic feeding/Carcinogenicity rat

See 870.4100a and 870.4200.

870.5100

Gene Mutation bacterial reverse mutation assay

Negative without and with S-9 activation up to limit dose of 5000 ug/plate.

870.5300

In vitro mammalian cell forward gene mutation assay (CHO cells/HGPRT locus)

Negative without and with S-9 activation up to the limit of solubility of 25 ug/mL.

870.5375

In vitro mammalian cytogenetics assay in Chinese hamster V79 cells

Negative without and with S-9 activation up to 3500 ug/mL with precipitation showing at concentrations of 100 ug/mL and higher.

870.5395

Cytogenetics - mammalian erythrocyte micronucleus test in the mouse

Negative at doses up to 2000 mg/kg.

870.5500

In vitro unscheduled DNA synthesis (primary rat hepatocytes)

Negative response up to 50 ug/mL.  Cytotoxicity at 100-500 ug/mL.

870.6200

Acute neurotoxicity screening battery (rat)

NOAEL:2000/1000 mg/kg/day (M/F)
LOAEL: >2000/2000 mg/kg/day (M/F): F = piloerection

870.6200

Subchronic neurotoxicity screening battery (rat)

NOAEL:1050.0/1272.5  mg/kg/day (M/F)
LOAEL: >1050.0/1272.5 mg/kg/day (M/F)

870.6300

Developmental neurotoxicity (rat)

Maternal NOAEL:1442 mg/kg/day
Maternal LOAEL: >1442 mg/kg/day
Offspring NOAEL: 14 mg/kg/day
Offspring LOAEL: 147 mg/kg/day (decreased body weights on PND 4 and decreased body weight gain on PNDs 1-4)

870.7485

Metabolism and pharmacokinetics (rat)

BAS 510 F was readily absorbed and excreted following single oral 50 mg/kg; at single 500 mg/kg or 15 doses of 500 mg/kg, absorption was saturated.  Excretion mainly by feces (80-98%).  Biliary excretion 40-50% of fecal activity at 50 mg/kg, 10% at 500 mg/kg.  Urine, about 16% at 50 mg/kg, 3-5% at 500 mg/kg.  Absorption about 56% at 50 mg/kg and 13-17% at 500 mg/kg.  Excretory patterns similar by gender or radiolabel position.  Metabolites (hydroxylation and conjugation products) were consistent with Phase I oxidation reactions followed by Phase II conjugation with glucuronic acid or sulfate, or by conjugation of the parent with glutathione with cleavage to sulfate metabolites.

870.7800
Immunotoxicity

MRID 48203801 (2003)

0, 100, 1000, or 10000 ppm 0, 7.45, 73.1, or 736.2 m/k/d

Acceptable / Guideline

NOAEL = 736.2 mg/kg/day
LOAEL = not established

870.7600

Dermal Penetration (rat)

Maximum % absorption:
0.01 mg/cm[2] = 10.93 (24 hour exposure, 24 hour sacrifice)
0.10 mg/cm[2] = 3.76 (24 hour exposure, 24 hour sacrifice)
1.00 mg/cm[2] = 1.48 (10 hour exposure, 72 hour sacrifice)

none

SPECIAL STUDY: Hepatic enzyme induction  (rat)

1. hypertrophy of zone III hepatocytes
2. >20% increase in liver weight
3. increase in CYP450 activity
4. slight to extensive microscopic SER proliferation
5. not a peroxisome proliferator
6. enzymes in CYP450 subfamily not induced
7. no notable microscopic increase in size or number of peroxisomes
CONCLUSION: inducer of total CYP450 activity

none

SPECIAL STUDY: Hormone and enzyme induction (rat)

1. slight (statistically significant) decrease in circulating T3 and T4 only in males
2. increase in circulating TSH levels both sexes
3. increase in all 3 liver microsomal glucuronyltransferases
CONCLUSION: disruption of thyroid homoeostasis by decreasing circulating T3 and T4 and increasing TSH; likely the result of hepatic microsomal glucuronyltransferase induction

none

SPECIAL STUDY: Reversibility study (dietary): 4-week administration followed by 4 weeks recovery or 13 weeks recovery (rat)

4 weeks dosing: at 2500 and 15000 ppm: increase in TSH (68% and 87%); increase in absolute and relative thyroid weights, hypertrophy of thyroid follicular epithelial cells and diffuse follicular hyperplasia, increase in absolute and relative liver weights and centrilobular hypertrophy as well as liver portal fatty changes.

4 weeks dosing + 4 weeks recovery: no increases in TSH; increase in absolute and relative thyroid weights; thyroid hypertrophy and hyperplasia decreased to control values; all liver effects reversed to control.

4 weeks dosing + 13 weeks recovery: no increases in TSH; increase in absolute and relative thyroid weights; thyroid hypertrophy and hyperplasia decreased to control values; all liver effects reversed to control.

CONCLUSION: induction of liver microsomal enzyme system resulting in increased glucuronidation of thyroxine, resulting in an increase in TSH secretion as a compensatory response of the physiological negative feedback system; increased TSH resulted in increased thyroid weight.

Appendix B.  Physicochemical Properties of Boscalid.

Table B.	Physicochemical Properties of Boscalid.
                                   Parameter
                                     Value
                                  References
Melting point/range
142.8-143.8 C
MRIDs 45404802 and 45404804-45404809
pH
NA (does not dissociate in water)

Relative Density (20ºC)
1.381g/cm[3]

Water solubility (20ºC)
4.64 mg/L at pH 6

Solvent solubility (g/100 mL at 20ºC)
acetone	16-20	ethyl acetate	6.7-8.0 methanol	4-5	2-propanol	<0.01 acetonitrile	4-5	dichloromethane 20-25 toluene 	2-5	n-heptane 	<0.01
1-octanol	<0.01	olive oil	2.9
N,N-DMF >25

Vapor pressure
7 x 10[-9] hPa

Dissociation constant, pKa
None (does not dissociate in water)

Octanol/water partition coefficient, Log(KOW)
2.96

UV/visible absorption spectrum
UV molecular extinction (e[lmol[-1]cm[-1]]):  3.15 x10[4] at 228 nm; 1.53 x10[3] at 290 nm

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 Globe Artichoke Crop Field Trials with Boscalid.
                                   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
                                  1.081-1.105
                                  (1.21-1.24)
                                       0
                                   Boscalid
                                       3
                                     1.159
                                     2.596
                                     1.446
                                     2.563
                                     1.722
                                     1.910
                                     0.582
[1]  Except for sample min/max, values reflect per trial averages; n = no. of field trials. Statistics were calculated by the study reviewer.
[2]  LAFT = lowest average field trial; HAFT = highest average field trial.

Table D-2.  Summary of Residue Data from Belgium Endive Crop Field Trials with Boscalid.
                                   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
                        1.14-1.18 g ai/100 lb of roots
                                     25-27
                                   Boscalid
                                       3
                                   <0.05
                                     0.15
                                   <0.05
                                     0.13
                                   <0.075
                                   <0.085
                                     0.041
      Treatment 03: One pre-forcing application to roots in packing tray
Belgium endive heads
                            0.177-0.192 g ai/ft[2]
                                     17-19
                                   Boscalid
                                       3
                                     0.25
                                     2.97
                                     0.28
                                     2.26
                                     1.75
                                     1.43
                                     1.028
Treatment 04: One pre-cold-storage application to roots + One pre-forcing application to roots in packing tray
Belgium endive heads
                      1.16-1.17 g ai/100 lb of roots and
                            0.182-0.199 g ai/ft[2]
                                     17-19
                                   Boscalid
                                       3
                                     0.43
                                     1.41
                                     0.455
                                     1.255
                                     1.05
                                     0.92
                                     0.416
[1]  Rate for boscalid, 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 (0.05 ppm) was used for any results reported as <LLMV
[3]  LAFT = lowest average field trial; HAFT = highest average field trial.

Table D-3  Summary of Residue Data from Persimmon Crop Field Trials with Boscalid.
                                   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
                                  1.110-1.126
                                  (1.24-1.26)
                                       0
                                   Boscalid
                                       3
                                     0.184
                                     3.285
                                     0.198
                                     3.019
                                     0.862
                                     1.360
                                     1.475
[1]  Except for sample min/max, values reflect per trial averages; n = no. of field trials.  Statistics were calculated by the study reviewer.
[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 Boscalid.
                               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
                                    ARI[8]

                                   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
                                     0.054
                                      410
                                     0.014
                                     1,500
                                      1.1
                          Airblast application of WDG
                                   Persimmon
                                      227
                                     8.96
                                     0.18
                                      40
                                    0.0061
                                     3,600
                                    0.0016
                                    14,000
                                      10
                        Chemigation application of WDG
                                      and
                         Groundboom application of WDG
                              Greenhouse tomatoes
                                      227
                                     8.96
                                     0.18
                                      60
                                    0.0092
                                     2,400
                                    0.0024
                                     9,000
                                      6.5
                         Groundboom application of WDG
                                   Artichoke
                                      227
                                     8.96
                                     0.18
                                      80
                                     0.12
                                     1,800
                                    0.0032
                                     6,700
                                      4.9
                                  Applicator
                              Aerial application
                                   Artichoke
                                   Persimmon
                                       5
                                     0.068
                                     0.18
                                      350
                                    0.0012
                                    18,000
                                    0.00011
                                    200,000
                                      95
                             Airblast application
                                   Persimmon
                                     1770
                                     4.71
                                     0.18
                                      40
                                     0.048
                                      460
                                    0.00085
                                    26,000
                                      3.9
                            Groundboom application
                              Greenhouse tomatoes
                                     78.6
                                     0.34
                                     0.18
                                      60
                                    0.0032
                                     6,800
                                   0.000092
                                    240,000
                                      53
                            Groundboom application
                                   Artichoke
                                     78.6
                                     0.34
                                     0.18
                                      80
                                    0.0042
                                     5,100
                                    0.00012
                                    180,000
                                      40
                                    Flagger
                                    Flagger
                                   Artichoke
                                   Persimmon
                                      11
                                     0.35
                                     0.18
                                      350
                                    0.0026
                                     8,400
                                    0.00055
                                    40,000
                                      27
                            Mixer/Loader/Applicator
                          Backpack application of WDG
                              Greenhouse tomatoes
                                    13,200
                                      140
                                    0.0018
                                   lb ai/gal
                                      40
                                      gal
                                    0.0036
                                     6,100
                                    0.00025
                                    86,000
                                      36
                   Manually pressurized handwand app of WDG
                              Greenhouse tomatoes
                                    100,000
                                      30
                                    0.0018
                                   lb ai/gal
                                      40
                                      gal
                                     0.027
                                      810
                                   0.000054
                                    400,000
                                      7.9
                    Mechanically pressurized handgun of WDG
                                   Artichoke
                                   Persimmon
                                     1300
                                      3.9
                                    0.0018
                                   lb ai/gal
                                     1000
                                      gal
                                    0.0088
                                     2,500
                                    0.00018
                                    120,000
                                      21
                    Mechanically pressurized handgun of WDG
                              Greenhouse tomatoes
                                     3500
                                      120
                                    0.0018
                                   lb ai/gal
                                     1000
                                      gal
                                     0.024
                                      920
                                    0.0054
                                     4,000
                                      2.8
                    Mechanically pressurized handgun of WDG
                   Belgium Endive  -  prior to cold storage
                                     1300
                                      3.9
                                   0.000028
                                lb ai/ lb root
                                    200,000
                                    lb root
                                     0.014
                                     1,600
                                    0.00027
                                    80,000
                                      13
                    Mechanically pressurized handgun of WDG
                      Belgium Endive  -  prior to forcing
                                     1300
                                      3.9
                                    0.0004
                                  lb ai/ft[2]
                                    10,890
                                     ft[2]
                                     0.011
                                     2,100
                                    0.00021
                                    100,000
                                      17
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).
8  Aggregate Risk Index (ARI) = 1/ (1 / RIdermal) + (1 / RIinhalation)
     Risk Index (RI) = MOE / LOC; Inhalation LOC = 1,000 and Dermal LOC = 100

Table E-2.  Occupational Post-application Non-Cancer Exposure and Risk Estimates for Boscalid.
                                   Crop/Site
                                  Activities
                        Transfer Coefficient (cm[2]/hr)
                                    DFR[1]
                                  (ug/cm[2])
                                 Dermal Dose
                                (mg/kg/day)[2]
                                    MOE[3]
                                   Artichoke
                                Hand Harvesting
                                     1,100
                                     1.01
                                    0.0167
                                     1,300

                        Hand Weeding, Thinning, Pruning
                                      70

                                    0.0011
                                    21,000

                                  Irrigation
                                   (Hand Set)
                                     1,900

                                     0.029
                                      760

                                   Scouting
                                      210

                                    0.0032
                                     6,900

                                 Transplanting
                                      230

                                    0.0035
                                     6,300
                                   Persimmon
                       Scouting, Hand Pruning, Training
                                      580
                                     1.01
                                    0.0088
                                     2,500

                  Hand weeding, Propping, Orchard Maintenance
                                      100

                                    0.0015
                                    14,000

                                Hand Harvesting
                                     1,400

                                     0.021
                                     1,000

                                 Transplanting
                                      230

                                    0.0035
                                     6,300

                                   Thinning
                                     3,600

                                     0.055
                                      400
                              Greenhouse Tomatoes
Hand Harvesting, Pinching, Hand Pruning, Scouting, Turning, Tying, Hand Weeding,
                                     1200
                                     1.01
                                     0.018
                                     1,200

                   Irrigation (Hand Watering), Transplanting
                                      230

                                    0.0035
                                     6,300
1 DFR = Application Rate x F x (1-D)t x 4.54E8 ug/lb x 2.47E-8 acre/cm[2]; where F = 0.25 and D = 0.10 per day
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.  International Residue Limits Status Sheet

                        Boscalid (128008); 02/21/2013)
Summary of US and International Tolerances and Maximum Residue Limits
Residue Definition:
US
Canada
Mexico[2]
Codex[3]
40 CFR §180.589. Plant commodities:
boscalid, 3-pyridinecarboxamide, 2-chloro- N -(4′-chloro[1,1'-biphenyl]-2-yl),
Plant commodities:

2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl)-3-pyridinecarbox-amide
-
Plant commodities:
 boscalid.  The residue is fat soluble.
Commodity[1]
Tolerance (ppm) /Maximum Residue Limit (ppm)

                                      US
Canada
Mexi-co[2]
Codex[3]
Artichoke, globe
                                      6.0
None

None
Belgium endive
(witloof chicory)
                                      6.0
None

None
Persimmon
                                      8.0
None

None
Vegetable, bulb, group 3-07
                                      5.0

5.0
Vegetable, fruiting, group 8-10
                                      3.0
1.4

3.0
Fruit, citrus, group 10-10
                                      2.0

2.0
Fruit, pome, group 11-10
                                      3.0
3.0

2 (Apple)
Caneberry, subgroup 13-07A
                                     10.0
6.0

10 (Berries and other small fruits)
Bushberry subgroup 13-07B
                                     13.0

10 (Berries and other small fruits)
Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F
                                      5.0
3.5

5 (Grapes)
Berry, low growing, subgroup 13-07G except cranberry
                                      4.5
4.5
Strawberry
11
Low bush blueberry

3 (Strawberry)
Oilseed group 20
                                      5.0
5.0
Canola oil
Mustard seed oil

1
Vegetable, root, except sugar beet, subgroup 1B, except garden beet, radish, and turnip
                                      2.0
0.7
Carrot
0.7
Rutabaga root
0.7
Burdock root
0.7 Ginseng root
0.7 Horseradish
[1 sugar beet
1 turnip root
1 radish root]

2 (Root and tuber vegetables)
Turnip, tops
                                      40
1.0

40 (Leafy vegetables)
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: August 15, 2008 (Volume 73, Number 159)]
[Notices]
[Page 47994-47996]
[DOCID:fr15au08-101]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58311; File No. SR-NYSE-2008-74]

Self-Regulatory Organizations; Notice of Filing of Proposed Rule
Change by New York Stock Exchange LLC To Enable the Exchange To Waive
Annual Listing Fees for Securities Transferring From the Amex or NYSE
Arca, Inc.

August 5, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Exchange Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby
given that, on August 4, 2008, the New York Stock Exchange LLC
(``NYSE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to provide that, with retroactive effect from
January 1, 2008, there shall be no annual fee payable to the Exchange
for the remainder of the calendar year in which the transfer occurs for
any class of securities of a company listed on the American Stock
Exchange (the ``Amex'') that transfers the listing of its primary class
of common shares to the Exchange. This proposed rule change (i) is
conditioned on the consummation of NYSE Euronext's acquisition of the
Amex (the ``Merger''), (ii) will not take effect until the date of
consummation of the Merger, and (iii) will be of no further effect if
the closing of the Merger does not take place by March 31, 2009. The
amendment also provides that companies transferring the listing of
their primary class of common stock from NYSE Arca, Inc. (``NYSE
Arca'') to the Exchange (with respect to which the Exchange already
waives annual fees for the first part year) will not be charged the
prorated annual fee in the first year of listing for any class of
securities that is transferred in connection with the transfer of the
common stock.

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

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

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

1. Purpose
    The Exchange proposes to amend Section 902.02 of the Manual to
provide that, with retroactive effect from January 1, 2008, there shall
be no annual fee payable to the Exchange for the remainder of the
calendar year in which the transfer occurs for any class of securities
of a company listed on the Amex that transfers the listing of its
primary class of common shares to the Exchange. This proposed rule
change (i) is conditioned on the consummation of Merger, (ii) will not
take effect until the date of consummation of the Merger, and (iii)
will be of no further effect if the closing of the Merger does not take
place by March 31, 2009. The amendment also provides that companies
transferring the listing of

their primary class of common stock from NYSE Arca to the Exchange
(with respect to which the Exchange already waives annual fees for the
first part year) will not be charged the prorated annual fee in the
first year of listing for any class of securities that is transferred
in connection with the transfer of the common stock.
    NYSE Euronext, the ultimate parent company of the Exchange, has
agreed to acquire the Amex pursuant to an Agreement and Plan of Merger,
dated as of January 17, 2008. It is currently anticipated that the
acquisition will be consummated during the third quarter of 2008.\3\ In
connection with the acquisition, the Exchange anticipates that some
Amex-listed companies that qualify for listing on the Exchange may
choose to transfer their listing to the Exchange. Consequently, subject
to consummation of the Merger, the Exchange proposes to amend Section
902.02 of the Manual to grant companies transferring the listing of
their primary class of common shares and any other class of securities
to the Exchange from the Amex a waiver of the prorated annual listing
fee that would normally be payable in connection with the first partial
calendar year of listing on the Exchange. The Exchange believes this is
appropriate as companies transferring to the Exchange from the Amex
will already have paid annual continued listing fees to the Amex for
the calendar year in which they transfer. Some companies may choose to
transfer from the Amex to the Exchange in advance of the consummation
of the acquisition. As such companies will be making their transfer
decisions in expectation of the Merger, the Exchange believes that they
should not be penalized for transferring before the closing date.
Consequently, the Exchange believes that it is appropriate to apply the
fee waiver retroactively to all companies that transfer to the Exchange
from the Amex during the portion of the year in which the Merger is
consummated prior to such consummation.
---------------------------------------------------------------------------

    \3\ The members of the Amex voted to approve the transaction on
June 17, 2008. No vote of the NYSE Euronext shareholders is
required. The sole remaining condition to the consummation of the
transaction is the approval by the Division of Trading and Markets
of certain rule filings in connection with the Merger that have been
submitted by the NYSE and Amex. After the Merger, the Amex will be
renamed NYSE Alternext U.S. LLC. The rule text included in Exhibit 5
reflects this name change.
---------------------------------------------------------------------------

    The Exchange believes this fee waiver is not unfairly
discriminatory and does not constitute an inequitable allocation of
fees, in particular because, after the Merger, NYSE Regulation, Inc.
(``NYSE Regulation'') will perform listed company regulation for both
the Exchange and NYSE Alternext U.S., including a substantial review of
companies upon original listing. Many of the regulatory staff who
currently perform initial and continued listing reviews at the Amex
will become employees of NYSE Regulation at the time of the Merger and
will continue to perform the same duties with respect to NYSE Alternext
U.S. companies after the Merger. Companies transferring from NYSE
Alternext U.S. will be subjected to the same rigorous regulatory review
as any other applicant for listing on the Exchange. However, the
Exchange expects that, on average, the review of companies transferring
from NYSE Alternext U.S. to the Exchange will be less costly than the
review of a transfer from an unaffiliated market, as the Amex listing
regulatory staff that will have been absorbed by NYSE Regulation will
already have performed a substantial review of any NYSE Alternext U.S.
listed company and NYSE Regulation will be able to rely on that prior
work as a baseline in qualifying the company for listing on the
Exchange and in conducting ongoing compliance activities with respect
to those companies.
    The Exchange also believes that waiving, subject to consummation of
the Merger, the prorated annual fees applicable to any Amex security
transferred to the NYSE prior to the Merger is not unfairly
discriminatory or an inequitable allocation of fees. Specifically, the
Exchange believes that the proposed fee waiver will not impact its
ability to devote the same level of resources to its oversight of the
companies that benefit from the waiver as it does for other listed
companies or, more generally, impact its resource commitment to its
regulatory oversight of the listing process or its regulatory programs.
The Exchange notes that, after consummation of the Merger, the annual
fee revenue paid by companies to the Amex prior to the Merger will be
available to NYSE Regulation to finance its regulatory activities in
relation to Amex-listed companies, regardless of whether such companies
remain on NYSE Alternext U.S. or have chosen to transfer their listing
to the NYSE at some point during the year either before or after the
Merger. As such, collecting annual fees from companies upon transfer
from the Amex to the NYSE would constitute a double billing of those
companies for the regulatory expenses incurred by NYSE Regulation in
relation to those companies during the year of transfer.
    Section 902.02 currently provides that any company transferring the
listing of its primary class of common equity securities from NYSE Arca
to the Exchange will not be charged any annual fees in connection with
the first partial year of listing on the Exchange. Consistent with the
Exchange's proposed approach to waiving annual fees for all securities
transferred from NYSE Alternext U.S. concurrent with the transfer of an
issuer's common stock, the Exchange proposes to extend the fee waiver
described in the immediately preceding sentence to the prorated annual
fees that would otherwise be payable with respect to any other class of
securities that an issuer is transferring to the Exchange from NYSE
Arca in conjunction with its transfer of its common stock. The Exchange
believes this waiver is appropriate in light of the fact that the
Exchange and NYSE Arca share a common parent and, without the waiver,
NYSE Euronext would be collecting two separate annual fees in relation
to such securities. In addition, the same staff from NYSE Regulation
are responsible for compliance review of all securities listed on both
markets and their prior experience with any securities transferring
from NYSE Arca will significantly lessen the burden and costs
associated with continued compliance review of those securities once
they have been transferred to the NYSE. Specifically, the Exchange
believes that the proposed fee waiver will not impact its ability to
devote the same level of resources to its oversight of the companies
that benefit from the waiver as it does for other listed companies or,
more generally, impact its resource commitment to its regulatory
oversight of the listing process or its regulatory programs.
2. Statutory Basis
    The basis under the Exchange Act for this proposed rule change is
the requirement under Section 6(b)(5) \4\ that an Exchange have rules
that are designed to promote just and equitable principles of trade, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system and, in general, to protect
investors and the public interest. The Exchange believes that the
proposed fee waiver does not render the allocation of its listing fees
inequitable or unfairly discriminatory because it is simply a
recognition of the fact that companies transferring their listing from
NYSE Alternext U.S. or NYSE Arca will already have paid fees

to another exchange which, in the case of NYSE Arca, is currently under
common ownership with the Exchange, and, in the case of NYSE Alternext
U.S. will, upon consummation of the acquisition, be under the same
ownership as the Exchange. The Exchange believes that the fee waiver is
not unfairly discriminatory and does not constitute an inequitable
allocation of fees because the same regulatory staff will review
securities on all three markets and the Exchange will therefore benefit
from regulatory efficiencies arising out of NYSE Regulation's prior
examination of any companies that transfer. The Exchange believes that
the application of the waiver to companies transferring to the NYSE
from Amex prior to the Merger is not unfairly discriminatory and does
not constitute an inequitable allocation of fees because the annual fee
revenue collected by the Amex from these companies will be available to
NYSE Regulation to finance its regulatory oversight of those companies
after the Merger.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purpose of the Exchange Act.

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve the proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send e-mail to<EMAIL_ADDRESS>Please include File
Number SR-NYSE-2008-74 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2008-74. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro/
shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, on official business
days between the hours of 10 a.m. and 3 p.m. Copies of the filing will
also be available for inspection and copying at the principal office of
the NYSE. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File number SR-
NYSE-2008-74 and should be submitted by September 5, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\5\
---------------------------------------------------------------------------

    \5\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-18893 Filed 8-14-08; 8:45 am]

BILLING CODE 8010-01-P