October 16, 2014 

Mr. James Parker 

Environmental Protection Agency 

Office of Pesticide Programs 

Risk Management and Implementation Branch I 

Pesticide Re-evaluation Division (7508P) 

One Potomac Yard 

2777 South Crystal Drive 

Arlington, VA 22202 

( 

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":- ----

Cc: Ms. Shaja Joyner; EPA Product Manager Team 20; Mail Drop 750SP 

RE: Dicloran (DCNA) Reregistration Generic Data Call-In (GDCI-D31301-27262) 

Dear Mr. Parker, 

Thank you for your and Mr. Moriarty's time on October 2, 2014 to discuss EPA's letter of August 26, 

2014 regarding the outstanding data requirements for dicloran (DCNA.) In our meeting we described 

the changing market needs for this product and reported that many significant uses can now be deleted 

from the label. A limited number of minor uses are still important to the growers and will be 

maintained. It is our understating that with these limited uses many data requirements listed in the 

above mentioned letter are now obsolete. We propose to perform the relevant residue chemistry and 

non-target data as outlined in the table below. Gowan will voluntarily cancel the following crops and 

application· 

Uses Proposed to be Removed Uses Maintained 

Application through backpack mist blower Celery 

Apricots Fennel 

Grapes Endive 

Peaches Onions/garlic/shallots 

Nectarines Snap beans 

Plums/Prunes Sweet potato 

Sweet Cherries Lettuce (leaf/head) 

Greenhouse cucumbers 

Greenhouse lettuce 

Greenhouse rhubarb 

Greenhouse tomato 

Chrysanthemums 

Gladiolus 

Roses 

Conifers 

Page 1 of 5 Dicloran Reregistration DCI 
Gowan is proposing to conduct the studies as detailed in Tables 1-4 below. These studies will be 

conducted in 2015 and could be submitted to the agency by September 30, 2016 contingent upon the 

availability ofthe contract laboratories and your approval ofthe proposed plan. 

Table 1-Occupational & Residential Exposure Data Requirement 

Guideline EPA Status 8/26/-2014 Gowan Proposa l10/2/2014 

875.1100- Dermal Exposure Waived n/a 

875.1300 -Inhalation Exposure Waived n/a 

875.2100- Foliar Dislodgeable Waived n/ a 

Residue 

875.2800- Description of Human Past due data for Label restriction applied 

Activity backpack mist blower 

Waiver is applicable 

Table 2- Plant Residue Chemistry Data Requirements 

Guideline EPA Status 8/26/2014 Gowan Proposall0/2/2014 

860.1300- Nature of the Residue Dat a submitted and waiver n/a 

- Plant submitted 

Waived 

860.1340- Residue Ana lytical Waiver Requested Gowan will conduct 

Method Waiver Denied: 

Storage Stability is required to 

complement MOR of residue 

data requirement 

860.1500- Succulent bean Waived Waived 

860. 1500- Crop field trial - Waived 

Cucumber 

860.1500- Crop field trial- EPA will use results of cherry Waived 

Peach crop field trial study further 

refine metabolite ratio Note: Cherries removed from 

determined in peach trial the label 

860.1500 - Crop field trial - Waived n/a 

Plum EPA will use results of cherry 

field trial study to further refine note: plum removed from label 

metabolite ratio determined in 

peach metabolism study 

860.1500- Crop field trial - Waived n/a 

Grape 

EPA will use results of cherry note: grapes removed from Ia~ ~~ 

crop field trial study further 

refine metabolite ratio 

determined in peach trial -- 860.1500- Crop field trial - Waiver pending; contingent Onion, garlic and shallots 

Garlic upon modification of DCNA currently have the same use 

product label; translate onion directions on all end use labels 

Page2of5 Dicloran Reregistration DCI 
data to garlic 

Waiver is applicable 

h860.1500- Crop field trial - Waiver pending; contingent See above 

Shallot upon modification of DCNA 

product label; translate onion 

data to garlic 

860.1500- Crop field trial - Waiver pending; contingent Fennel and celery currently have 

Fennel upon modification of DCNA the same use directions on all 

product labels Gowan must labels 

change label use directions on 

DCNA products to make fennel 

match celery; translate celery Waiver is applicable 

data to fennel 

860.1500 - Crop field trial - Waiver pending; contingent 

Rhubarb upon modification of DCNA Note: rhubarb is removed from 

product labels Gowan must labels 

change label use directions on 

DCNA products to make rhubarb Waiver is applicable 

match celery; translate celery 

data to rhubarb 

860.1500 -Crop field trial - Waiver pending; contingent Note: apricots are removed from 

Apricot upon modification of DCNA all labels 

product labels Gowan must 

change label use directions on Waiver is applicable 

DCNA products to make apricot 

match other stone fruits 

860.1500- Crop field trial - Wavier denied Per guideline (EPA guidance: 

Sweet Potato The Agency agrees to remove "case by case"); OECD 12/2011 

requirements for analysis for the Guidance Doc on Crop Field 

degradate "unknown 1"; Trials #93 : 4 trials to be 

samples should be analyzed for conducted; DCNA and DCHA; 

residue of parent and DCHA. post-harvest residue data and 

tolerance would be protective of 

plant bed uses. 

860.1500- Crop field trial - Analyze samples for both parent Note: Cherry removed from 

Cherry and DCHA; labels 

ratio (DCNA/DCHA) to peach Waiver is applicable 

and plum 

Waiver denied ___ J 

860.1500- Crop field trial - Dry Waiver denied Per EPA guideline, 8 trials (1o 

I bulb onion EPA removes the requirement samples) to be conducted in the for analysis of the degradate 2015 growing season; DCNA & 

"Unknown 1 "; continue to apply DCHA residues 

degradate "Unknown I" factor 

for risk assessment purposes; 

Page 3 of 5 Dicloran Reregistration DCI 
samples should be analyzed for 

residues of parent and DCHA 

n860.1520 - Processed Waiver requested Tomato removed from label; 

food/feed - Tomato Waiver denied 

Waiver is applicable 

860.1520 - Processed food/feed Waived n/a 

Potato 

860.1520 - Processed food/feed Waiver denied Grapes removed from label; 

grape Waiver is applicable 

860.1520- Processed food/feed Waiver denied Plums removed from label; 

Plum 

Waiver is applicable 

860.1900 - Field Rotational Crop Waiver denied Field rotational study to be 

conducted in 2015 to determine 

plant back intervals 

Table 3 - Terrestrial/Aquatic Non-target Data Requirements 

Guideline EPA Status 8/26/-2014 Gowan Status 10/2/2014 

850.1025 - Oyster Acute toxicity Waiver submitted and data Gowan will conduct this study in 

test referenced 2015; 

Waiver Denied 

850.1075 - Estuarine/Marine Waiver submitted for n/a 

Fish Acute estuarine/marine species. 

Waiver granted 

850.1075- Freshwater Fish Acute Data available n/a 

toxicity test 

850.1400- Fish Early Life Early Waiver submitted and data Gowan will conduct this study in 

Stage (freshwater) test submitted; 2015 

Waiver denied 

850.2300 - Avian/Mallard duck Data submitted n/a 

reproduction Data classified as acceptable 

850.4100 - Seedling Emergence Waiver request; waiver denied Gowan will conduct this study in 

Tier 1 Due date extended to Jul 29, 2015 

2010 

850.4100 - Vegetative Vigor Waiver request; waiver denied Gowan will conduct this study in 

Due date extended to Jul 29, 2015 

2010 

Page 4 of 5 Dicloran Reregistration DCI 
Table 4- Summary of Toxicological Data Requirements 

Guideline EPA Status 8/26/-2014 Gowan Status 10/2/2014 

870.346S- 90/28 Day inhalation Waiver requested Pending reregistration risk 

Toxicity Waiver denied assessment on attached revised 

label 

870.6300- Developmental Waiver requested Pending reregistration risk 

Neurotoxicity Waiver denied assessment on attached revised 

label 

Registrant may conduct an 

acute/subchronic neurotoxicity 

study (GLN 870.6200) to 

potentially defer the GLN 

870.6300 requirement 

Per your request we are attaching the following proposed labels with the remaining crops and use 

patterns. 

1. Botran P SF, EPA Reg. No. 10163-329 

2. Botran SF, EPA Reg. No. 10163-226 

3. Botran 7S-W, EPA Reg. No. 10163-189 

4. Botran Technical, EPA Reg. No. 10163-195 

Gowan appreciates the Agency's consideration and time on this fungicide. If there are questions 

regarding this proposal, please contact Nina Wilson at 928-819-1SS2 or at n~ 1lson@gowanco.com or 

Kyla Smith at 928-819-1S31 or ksmith@gowanco.com. 

Regards, 

1(~· Nina Wilson 

Regulatory Scientist 

Gowan Company 

370 South Main Street 

Yuma, AZ 8S367 

Page 5 of 5 Dicloran Reregistration OCI