# EnlistTM Weed Control System

TM Colex
- D, and Enlist are trademarks of Dow AgroSciences LLC. Components of the Enlist Weed Control System have not yet received regulatory approvals; approvals are pending. The information presented here is not an offer for sale. Enlist Duo is not yet registered for sale or use as a component of the Enlist Weed Control System. Always read and follow label directions

.

# Terminology

• Enlist Weed Control System

– Enlist trait in corn ( aad
- 1 )

– Enlist Duo Herbicide
• Lead commercial offering

– 2,4 - D choline + Glyphosate DMA


## • Event

– DAS
- 40278 - 9
• Gene

– aad
- 1
• Protein

– AAD
- 1

# Overview

• Herbicide Tolerant Crops
• Glyphosate resistant weeds
• Resistance management
• AAD
- 1
• Current and future use of 2,4
- D herbicide in corn
• Colex
- D Herbicide Technology
• Herbicide Drift and Volatility

# Glyphosate tolerant crop adoption

# Heavy weed pressure on a single herbicide molecule

• Result

– A quadrupling of the amount of glyphosate use in corn, soybeans and cotton


## • Effect

– Increasing number of glyphosate
resistant weeds

– Increase number of hard
- to - control weeds


## • Implication

– Glyphosate systems alone not the answer Glyphosate 4x rate Glyphosate
- resistant w aterhemp Southern IL

Hard
- to - control velvetleaf and lambsquarters Glyphosate used alone

# Documented glyphosate resistance

• Marestail first U.S. weed documented as glyphosate
- resistant 1
• In 2010, there were 10 weeds with documented resistance to glyphosate
• Resistant weeds are spreading geographically 2011 2000

Marestail

 Marestail  G. Ragweed  C. Ragweed  P. Amaranth  Kochia  Waterhemp  Johnsongrass  Italian Ryegrass 2011 Geographic Dispersion of Glyphosate - resistant Weeds

2011 2004

P. Amaranth

Sources: weedscience.org, Clemson University as of November 2011

# Weed Control Challenges

• Increasing issue on farms across the U.S. in multiple crops

• Glyphosate resistance has heightened awareness of the issue

– Weed control issues are more broad than glyphosate resistance

• Herbicide tolerant crops did not cause weed resistance

– Virtually all modes of action have some weed resistance development Growers Reporting Difficult
- to - Control Weeds 1

1. Proprietary market research study conducted among Midwest, Mid South and Southeast growers. Jefferson Davis and Associates, February 2011.0% 5% 10% 15% 20%

G. Ragweed Waterhemp Waterhemp C. Ragweed Corn Soybeans 

# Prevalence of Weeds Negatively Impacts Production

• The need for weed control is agronomic and impacts production

• Herbicide resistance is a key driver for the need for new technology and inclusion of diverse modes of action

• New modes of action are extremely difficult to find and are 8
- 10 years away from market Negative Yield Impact from Weeds in Corn & Soybeans 2

S. Minnesota Giant Ragweed 2. Integrated Pest & Crop Management Newsletter , University of Missouri Vol. 14, No. 11 Article 8 of 10, June 4, 2004; The Glyphosate, Weeds and Crops Series: Biology and Management of Common Ragweed Tom Jordan, Purdue University; Glenn Nice, Purdue University; Reid Smeda, University of Missouri; Christy Sprague, Michigan State University; Mark Loux, Ohio State University; Bi ll Johnson, Purdue University; **The Glyphosate, Weeds and Crops Series:** Biology and Management of Waterhemp Dawn Nordby, University of Illinois Bob Hartzler, Iowa State University Kevin Bradley, University of Missouri; **The Glyphosate, Weeds and Crops Series:** Biology and Management of Common Ragweed Tom Jordan, Purdue University, Glenn Nice, Purdue University, Reid Smeda, University of Missouri, Christy Sprague, Michigan State University, Mark Loux, Ohio State University, Bill Johnson, Purdue University

# Multiple Modes of Action

– An important part of sustaining weed control The National Research Council and Weed Science Society of America agree that:

• Use of a single mode of action is considered unsustainable and recommend using a diversified weed management system

• Both cite use of herbicides with different modes of action as one of the important tools in such a program

# Weed Resistance Management Strategies

Management Option Risk of Resistance Development Low Moderate High

Herbicide mix or rotation in cropping system >2 modes of action 2 modes of action 1 mode of action Weed control in cropping system Cultural, mechanical and chemical Cultural* and chemical Chemical only Use of same MOA per season Once More than once Many times Cropping system Full rotation Limited rotation No rotation Resistance status to MOA Unknown Limited Common Weed infestation Low Moderate High Control in last 3 years Good Declining Poor

# DAS
- 40278 - 9 corn and Enlist TM Herbicide Solution

• New herbicide tolerant traits that provide robust tolerance to 2,4
- D
• Will be stacked with glyphosate tolerance traits

– Will allow use of an additional mode of action without changing the farming system that growers have adopted 

### • Includes a new and innovative 2,4
- D choline based herbicide
• Enlist herbicide will feature technology to reduce potential off
- target movement
• Will be promoted with additional weed control modes of action (foundation chemistries, mechanical control, crop rotations)

# DAS
- 40278 - 9 Corn: What is it?

• DAS
- 40278 - 9 corn contains the aad
- 1 gene, which expresses the AAD
- 1 protein

– aad
- 1 was isolated from common soil bacterium Sphingobium herbicidovorans

– Provides tolerance to registered herbicides of the chemical families:
• Phenoxy auxins (e.g., 2,4
- D)
• Aryloxyphenoxypropionate (AOPP or “fop”) graminicides (e.g., quizalofop, cyhalofop , haloxyfop, ...)


## • Corn has some intrinsic tolerance to 2,4
- D, and 2,4
- D is currently registered by US EPA for use on corn

– Usage is low because of potential occurrence of crop injury

# AAD
- 1: How does it work? Phenoxy auxins (e.g., 2,4

- D) Broad

- spectrum, inexpensive, durable, primarily broadleaf herbicides



## Aryloxyphenoxypropionates (e.g., quizalofop, cyhalofop, haloxyfop) Broad

- spectrum, highly

- active grass

- specific herbicides O O H O Cl Cl 2,4 - D

Quizalofop O H Cl Cl

N N O
O H Cl AAD

- 1 Inactive

AAD

- 1 Inactive N N O
O O H O Cl



### • Provides robust tolerance to pre

- emergence and post

- emergence applications of 2,4

- D
• Robust tolerance to applications of all “fop” herbicides DCP

# DAS
- 40278 - 9 Corn: How will it be marketed and used?

• DAS
- 40278 - 9 will be “stacked” through conventional breeding with other corn traits that have been previously deregulated.

• DAS
- 40278 - 9 is a complement to existing herbicide
tolerant traits, not a substitute

# Benefits to Utilizing AAD
- 1 Corn

• Allows use of a broad
- spectrum herbicide MOA for use in glyphosate tolerant application systems. Improves control of key hard
- to - control broadleaf weeds compared to glyphosate systems alone.

• 2,4 - D controls “ weed shifts ” that are hard to control with glyphosate alone, reducing the need for increasing glyphosate rates

• 2,4 - D provides an effective resistance management / prevention solution. Low cost, high performance solution to reduce escalation of glyphosate (and ALS) resistance in mono and dicot weeds.

• 2,4 - D extends and protects the utility of glyphosate :

– The most widely used herbicide in crop and fallow:

– Glyphosate cropping system is simple, reliable and robust

– Roundup Ready market penetration predicted for 2011: corn (90%), soybean (95%), cotton (75%)

– Supports conservation tillage farming systems

• Quizalofop provides a new MOA selectable marker for stacking traits• Eliminates interval (up to 14 days) between pre
- plant application and planting.
• Eliminates drop nozzles for corn greater than 8”
• Allows 1 lb ae/A per application with max of 2 broadcast applications, POST through V8 or 48” corn.
• 2,4 - D can be applied selectively when weed control is needed and most effective, overlapping with glyphosate application window 

### 3 lb ae/A Maximum seasonal rate



### 3 lb ae/A Planting Current use pattern of 2,4 - D for conventional corn

Pre - Harvest 1.5 lb ae /A Pre - plant 1 lb ae /A Post 0.5 lb ae /A If < 8” over the top If > 8” off foliage

Proposed use of 2,4 - D for DAS 40278 - 9 Corn

Corn stage

V8 / 48” Pre - plant 1 lb ae /A Minimum 12 days apart Post 1lb ae /A Post 1lb ae /A 

# Use of 2,4

- D on DAS 40278

- 9 Corn• Provides up to 1 lb ae/A of each active ingredient per application with maximum of 2 post emergent broadcast applications through V8 or 48” corn

. Planting Corn stage V8 / 48” Pre - plant Minimum 12 days

apart Post Post 

# Proposed Use of 2,4

- D/glyphosate (Enlist Duo) on DAS 40278

- 9 Corn

# Proposed Quizalofop Use Pattern with Enlist Corn

Quizalofop new use in Enlist Corn : • Selection agent for transgenic (AAD
- 1) seed corn production
• POST grass control option.
• Normal use rate currently recommended for grass control in soybean and cotton
. • Total seasonal use no greater than current in
- crop use rate (0.082 lb ae /A)
• Selective use of Fop use will be new for corn. Provides optimal use timing as a

selection agent and for control of grasses. Post up to 0.082 lb/A New use pattern for Dow AgroSciences Enlist Corn V6

# Enlist Duo  Herbicide with Colex
- D Technology

• Regulatory approval by EPA required for all herbicide products.

• Enlist Duo will be the only auxin
- based herbicide allowed post
- emergent on DAS
- 40278 - 9 corn.

• Violation of federal l aw to use a herbicide inconsistent with an EPA
- approved label.

# Colex
- D Technology

# Colex
- D TM 

# Technology

• 2,4 - D choline

– Novel use of an essential human nutrient

– Most non
- volatile 2,4
- D product

– Improved eye irritation

– Enhanced product handling features



### • Latest formulation science and techniques

– Significant decrease in driftable fines



### • State of the Art Manufacturing Processes

– Major reduction in odor

– Traditional 2,4
- D odor virtually non
- detectable at edge of field

# Why 2,4
- D Choline?

• Arose from a desire to fundamentally change aspects of traditional 2,4
- D

– Greatly reduce potential for off
- target herbicide movement
• Esters were a non
- starter
• Could a form be found with even lower volatility than amines?

– Enhance the toxicology profile
• Toxicity profile of counter ions
• Eye irritation potential of amines and 2,4
- D acid

– Improve handling characteristics
• Cold weather handling
• Mixability

# Field Volatility Study Design

• 4 sites

– 2010 (2,4
- Ds only)
• Farmland, IN
- Soybean (12”)
• Fowler, IN

– tilled bare soil

– 2011(tank mixes and premix)
• Little Rock, AR

– soybeans (5
- 6”)
• Ty Ty, Georgia

– cotton (12”)

• Sampling

– Indirect flux measurement

– 5 and 15 m from plot boundaries

– Air
- sampling pumps, 1 L/min

– OVS tubes, XAD
- 2 resin
• c. 6 - hour intervals
• to c. 72 hours

• Conditions

– Farmland

– 60s
– mid
- 80s, 45 - 100% RH, no precip

– Fowler

– low 50s

– mid
- 80s, 26 - 98% RH , 1.2” rain late day 2

– Little Rock – high 70s – high 90s, 35 - 96% RH, 0.1” in rain night day 2

– Ty Ty – mid - 60s – high 90s, 24 - 97% RH, no precip

– Soil very dry in all sites

# Three Day Cumulative Vapor Loss of 2,4
- D

0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5

0 12 24 36 48 60cumulative mass loss, % ofapplied

Hours after treatment Farmland (80% canopy)

Choline DMA EHE

0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5

0 12 24 36 48 60cumulative mass loss, % ofapplied

Hours after treatment Fowler (bare soil)
Choline DMA EHE 0.0% 0.5% 1.0% 1.5% 2.0% 2.5% 3.0% 3.5% 4.0% 4.5%

0 12 24 36 48 60 72cumulativemass loss, % ofapplied

Hours after treatment Arkansas (15% canopy)

choline alone choline + glyphosate DMA EHE

0.0% 0.5% 1.0% 1.5% 2.0% 2.5% 3.0% 3.5% 4.0% 4.5%

0 12 24 36 48 60 72cumulativemass loss, %applied

Hours after treatment Georgia (40% canopy)

choline alone choline + glyphosate DMA EHE

# Cumulative losses greatly reduced with 2,4 - D choline

Site EHE DMA 2,4 - D choline Alone 2,4 - D choline + Glyphosate Farmland 3.83% 0.71% 0.33% -

Fowler 1.55% 0.62% 0.20% - Little Rock* 3.9% 0.81% 0.08% 0.09% Ty Ty* 2.83% 0.91% 0.02% 0.01%

* non
- optimized fluxes • 2,4 - D choline avg 6x lower than DMA
• 2,4 - D choline avg 24x lower than EHE

# Prediction at Larger Scale Simulated exposure from 40
- acre treatment area: first 6 hours after application
- units: (μg/m 3 

## )
- hr

• Relate model estimates over time to plant effects => risk assessment & stewardship recommendations Choline

meters -400 -200 0 200 400 600 800meters

-400 -200

0 200 400 600 800
0.0 0.5 1.0 1.5 2.0 2.5 3.0 DMA

meters -400 -200 0 200 400 600 800meters

-400 -200

0 200 400 600 800 EHE

meters -400 -200 0 200 400 600 800meters

-400 -200

0 200 400 600 800

# Volatility Summary

• Novel 2,4
- D choline salt showed consistent reduction of volatile loss potential

• 2,4 - D choline averaged 96% reduction vs. ester

• 2,4 - D choline average 84% reduction vs. DMA

# Enlist TM Herbicide spray drift research

# Technologies for Controlling Spray Droplet Size

• Application Equipment

– Nozzle type , application parameters (boom height, pressure, speed, etc) have major effect on droplet size



# • Formulation (Spray Solution) Properties

– Tank mix composition is generally viewed as less important than application parameters, but as will be shown, can be significant

## Spray Droplet Size Distribution of New Premix Formulation vs. 2,4
- D + Glyphosate Tank Mix

0 0.5

1 1.5

2 2.5

1 10 100 1000 10000 Particle Size (um)Density Distribution 15 GPA DAS Premix 10 GPA DAS Premix 15 GPA T.M. of DMA6 and Durango DMA 10 GPA T.M. of DMA6 and Durango DMA Sample 15 GPA Premix 10 GPA Premix

15 GPA Tank Mix 10 GPA Tank Mix d(0.5) 271 265 150 148 % Fines

16.8% 18.8% 50.2% 51.1%

# 2,4 - D Choline + Glyphosate Premix

• Incorporates the attributes of the new 2,4
- D choline
• Utilizes new formulation advancements to improve particle size distribution and reduce drift

# Field study

– McCook, NE

• ISO standard 22866/ASABE 561.1/EPA DRT draft

• 2 application plots

– Plot 1

– 180 x 460 ft

– Plot 3

– 180 x 535 ft

• Triplicate downwind collectors

– Tracer dye and 2,4
- D analytical

• Winds 3

– 11 mph

• Application with commercial equipment

• Enlist Herbicide Solution premix vs. tank mix

• 3 nozzles

– XR
- Medium

– AIXR

– Very/extremely coarse

– TTAI

– Ultra coarse

• 37 total treatments

# Comparison of deposition at 100 feet normalized to the tank mix deposition with XR nozzle

0.00 0.10 0.20 0.30 0.40 0.50 0.60 0.70 0.80 0.90 1.00

XR TTAI AIXRRelative deposition @ 100 ft

Tank Mix Enlist Duo Tank mix Enlist Herbicide Solution

# EnlistTM Weed Control System Stewardship Overview

TMEnlist and Enlist Duo are trademarks of Dow AgroSciences LLC. Components of the Enlist Weed Control System have not yet received regulatory approvals; approvals are pending. The information provided here is not an offer for sale. ©2011 Dow AgroSciences LLC

# Stewardship Program Goals

• Addresses both crop and herbicide

• Provide Comprehensive Guidance and Education on Responsible Use

• Promote Use of Authorized Herbicides

• Minimize Potential Off
- Target Movement

• Promote Weed Resistance Management

• Promote Responsible Use and Worker Safety

• Support Compliance with Regulatory Requirements Integrated Stewardship Program

# Integrated Stewardship Program

• Built upon existing stewardship programs for agricultural chemicals and seed traits

• Obtained input from key stakeholders and functional subject matter experts Technology Advancements

Management Recommendations and Resources Education, Training and Outreach Integrated Stewardship Program

# Introducing Enlist Ahead

• First
- of
- its
- kind management resource

• Designed for the grower and applicator

• Benefits
- based resource

• Helps growers succeed while promoting responsible use of the Enlist system

• Will offer technology advancements, management recommendations & resources, and education, training & outreach

# Enlist Ahead

Technology Advancements

Education, Training and Outreach Foundational Pillar What How Herbicide products that will provide:

• Exceptional weed control
• Convenience for the grower and applicator
• Built
- in drift reduction to minimize the potential

for off
- target movement

Train growers and applicators on:

• Enlist basics and Colex
- DTM Technology
• Spray equipment and application practices
• Managing product use near sensitive crops
• Weed resistance management Encourage dialogue between neighbors • In
- field and instructor
- led training
• Interactive online learning modules
• Support online sensitive crop registries
• Collaborate with value chain and

industry associations Management Recommendations and Resources Provide management recommendations and resources to:

• Promote responsible use of the Enlist system
• Minimize the potential for off
- target movement • Promote weed resistance management

practices
• Promote biotechnology trait stewardship • Product Labels
• Technology Use Agreements
• Product Use Guides
• Required use of authorized herbicides
• Use of alternative MOA herbicides
• Tools for selection of proper

application equipment and practices
• Communications to distributors, retailers, growers, and applicators

# Stewardship Program Components

• Authorized Herbicide Product Label (submitted to EPA)
• Access Authorized via Signed Technology Use Agreement
• Comprehensive Product Use Guides
• Education and Training for Distributors, Retailers, Growers and Applicators
• Product Stewardship Tools and Resources
• Compliance Monitoring and On
- Farm Assessments Integrated Stewardship Program

### • Requires applicators to follow all state and local pesticide requirements regarding application of 2,4 - D herbicides
• Does not allow application into areas of temperature inversion
• Restricts ground applications to wind speeds less than or equal to 15 mph
• Requires using spray nozzles in accordance with manufacturer recommendations that produce a droplet size classification of coarse or coarser (ASABE S
- 572 standard)
• Recommends use of drift reduction nozzles 

# Authorized Herbicide Product Label

Technology Advancements

### • Requires an upwind setback of 250 feet from sensitive areas if coarse or very coarse droplet classifications cannot be maintained

• Requires use of properly maintained and calibrated ground application equipment with minimum boom heights based upon nozzle manufacturer’s recommendations

• Provides instructions for sprayer and equipment clean
- out after product use

• Does not allow aerial or chemigation applications (i.e. ground application only) 

# Authorized Herbicide Product Label

Technology Advancements

### • Requires growers to utilize approved Dow AgroSciences authorized herbicides only for in
- crop applications
• Requires growers to adhere to Product Label and Product Use Guide requirements
• Requires growers to provide access to information about utilization of the technology and allow on
- farm assessments
• Provides Dow AgroSciences the right to revoke technology access if stewardship obligations are not met
• Use of any herbicide or combination of herbicides not authorized by the Technology Use Agreement would infringe patents owned by DAS 

# Access Authorized Via Technology Use Agreements

Technology Use Agreements

# Comprehensive Product Use Guides

Technology Advancements

Education & Training • Authorized Use via Grower Agreements
• Stakeholder Outreach
• Technical Information
• Compliance

Monitoring Tools & Activities Product Use Guidelines 

### • Requires growers to read and follow all FIFRA Pesticide Product Label directions

• Requires growers to utilize only approved Dow AgroSciences authorized herbicides for in
crop applications

• Requires growers to adhere to Weed Resistance Management practices

• Recommends growers utilize herbicide products with additional modes of action

# Education, Training and Outreach

Technology Advancements

Education & Training • Authorized Use via Grower Agreements
• Stakeholder Outreach
• Technical Information
• Compliance

Monitoring Tools & Activities 

### • Reinforces requirements to adhere to product use guidelines, pesticide product label, and all product stewardship requirements for responsible use and proper stewardship of the technology

• Provides product guidance at retail locations on responsible use of the technology to promote proper stewardship

• Includes responsible use of trait and herbicide technology, weed resistance management, spray technology and stewardship requirements

• Diverse modes of delivery including webinars, Instructor
- Led
- Training, online modules and field demonstrations for growers, applicators, retailers and distributors Education, Training and Outreach

# Ongoing Training and Communications

• Building an external Learning Management System specifically for the channel and end
- users
• In
- field training including spray application training

• Grower and channel focused communications supplemental to regulatory documents

• Websites

# Enlist 360

• Comprehensive training effort for retailers, applicators, seed sellers and growers

• Enlist 360 will include training information delivered in diverse learning methods including computer based, classroom, hands
- on and in
- field

• Contracted with an adult learning company for development of training modules

• Training name and consistent look helps the end
- user understand the four training elements are linked

Information SheetField Training Learner Guide

# Investment in Training Equipment

# Compliance Monitoring

• Will conduct grower surveys and on
- farm assessments to monitor compliance with the Technology Use Agreement and Product Use Guides

• Upon request, technology users must provide information regarding the location of fields planted with Enlist corn and the herbicides used

• Have dedicated hotline to report potential incidents involving Enlist products

• Will investigate allegations and follow
- up, as needed

• Failure to follow the stewardship requirements will result in:

– education and reinforcement of stewardship requirements with growers, applicators, and retailers;

– additional education and training; and/or

– loss of access to the technology Compliance Monitoring

# Tools and Resources

• AdvanceFarming.com

• Trait Stewardship Website

• Enlist Weed Control System Technical Bulletin

• Customer Service and Product Information Hotline

• Trained and Dedicated Enlist Field Specialists

• Additional product support resources include Product Stewardship Specialists, Customer Agronomists, Field Biologists, Product Managers, Crop Protection and Seed Sales Representatives Tools and Resources

# Overview of Submitted Documents

TMEnlist and Enlist Duo are trademarks of Dow AgroSciences LLC. Components of the Enlist Weed Control System have not yet received regulatory approvals; approvals are pending. The information provided here is not an offer for sale. ©2011 Dow AgroSciences LLC

# DAS Supplied Materials DAS has submitted numerous documents to APHIS that are part of the administrative record relating to DAS
- 40278 - 9 corn deregulation (including documents related to EPA’s review of 2,4
- D)

• Intent: Provide pertinent facts/data to APHIS to inform the drafting of the EA and response to comments

• Types of Material:

– DAS
- 40278 - 9 Corn Petition

– DAS research summaries: drift/volatility

– DAS Educational materials: Enlist TM Weed Control System , Stewardship Program

– Scientific papers/published abstracts: utility of AAD
- 1 transgenes

– Submissions/responses/decisions from EPA/FDA

– DAS authored ‘white papers’ on specific topics: technology benefits, Stewardship Program, herbicide use

– DAS comments to the docket

# DAS Supplied Materials Documents Supplied in Support of Draft EA Development

• Provide APHIS with new information expanding on original petition
• Develop the context for the product and its development Document Key Information Background Enlist TM Technical Bulletin Overview of DAS-40278-9 Corn and other technologies comprising the Enlist TM Weed Control System PNAS Articles and Letters to Editor Robust crop resistance to broadleaf and grass herbicides provided by aryloxyalkanoate dioxygenase transgenes 2,4-Dichlorophenoxyacetic acid (2,4-D)–resistant crops and the potential for evolution of 2,4-D–resistant weeds Reply to Egan et al.: Stewardship for herbicide-resistance crop technology Scientific description of the utility of AAD transgenes in conferring herbicide tolerance to crops. Related discussion of development of herbicide resistant weeds

ISB News Report Utility of Aryloxyalkanoate Dioxygenase Transgenes for Development of New Herbicide Resistant Crop Technologies Description of the utility of using AAD transgenes as an effective new tool allowing for sustainable weed management strategies U.S. EPA Tour of Weed Resistance Management Challenges in Missouri, Illinois, and Arkansas Documents the problems related to gyphosate-resistant weeds being faced by growers

# DAS Supplied Materials Documents Supplied in Support of Draft EA Development

• Provide APHIS with new information expanding on original petition
• Develop the context for the product and its development 

### Background Information:

• Enlist TM Technical Bulletin

– product information

• PNAS Articles and Letters to Editor

– transgene development and utility

• ISB News Report

– application to weed resistance management

• U.S. EPA Tour of Weed Resistance Management Challenges

# DAS Supplied Materials Documents Supplied in Support of Draft EA Development
• Economic and agronomic benefits of DAS
- 40278 - 9 corn when 2,4
- D is used for weed control Document Key Information Benefits of DAS-40278-9 Corn

Economic and Agronomic Impacts of the Introduction of DAS40278-9 Corn on Glyphosate Resistant Weeds in the U.S. Cropping System 1/ Benefits of Glyphosate Tolerant Crops 2/ Weed Management in Glyphosate Tolerant Corn and Soybeans 3/ Long-term Weed Resistance Management through Use of Herbicide Tolerant DAS-40278-9 4/ Economic Benefits of Dow AgroSciences Herbicide Tolerant Technology 5/ Impact of 2,4-D on Herbicide Tolerant DAS-40278-9 Corn and DAS-68416-4 Soybeans on the Cost and Environmental Load of Herbicides Applied on Glyphosate Tolerant Corn and Soybeans Projected herbicide use and impact of EnlistTM Weed Control System vs. alternatives Examines changes in herbicide application in corn and soybean with and without adoption of Enlist crops Research Demonstrating Reduction in Potential Off-Target Movement for 2,4-D Choline and Colex-DTM Technology as Part of the EnlistTM Weed Control System Provides information related to volatility and spray drift characteristics associated with 2,4-D choline and the proprietary formulation comprising Colex-DTM Technology that is part of the EnlistTM Weed Control System.

# DAS Supplied Materials Documents Supplied in Support of Draft EA Development
• Economic and agronomic benefits of DAS
- 40278 - 9 corn when 2,4
- D is used for weed control
Benefits of DAS - 40278 - 9 Corn:

• Economic and Agronomic Impacts of the Introduction of DAS
- 40278 - 9 Corn on Glyphosate Resistant Weeds in the U.S. Cropping System

• Projected Herbicide Use and Impact of EnlistTM Weed Control System vs. Alternatives

• Research Demonstrating Reduction in Potential Off
- Target Movement for 2,4
- D Choline and Colex
- DTM Technology as Part of the EnlistTM Weed Control System

# DAS Supplied Materials Documents Supplied in Support of Draft EA Development
• Establish the ongoing regulatory activities and respective accountabilities of US
EPA and APHIS pertaining to DAS
- 40278 - 9 corn and 2,4
- D/ quizalofop Document Key Information Regulatory Information Regulatory Overview of 2,4-D and Quizalofop Summary of US-EPA regulatory authority and status of 2,4-D and quizalofop at EPA Summary of 2005 2,4-D Reregistration Eligibility Document (RED) Major conclusions from RED and information from the US EPA 2,4-D RED Facts website (e.g. use profile, regulatory history, human health and environmental assessment) GF-2654 TC US- EPA Data Submission Letter Supporting data for 2,4-D choline submitted to EPA
Draft Label GF-2654 TC Submitted to US-EPA Details of proposed label for 2,4-D choline including herbicide resistance management, spray drift management and application directions.
GF-2727 TC Label Amendment Amendment submission to register the use of a premix of 2,4-D choline and glyphosate DMA on DAS-40278-9 corn US-FDA Conclusion of Consultation Letter re: DAS-40278-9 Corn Documentation of conclusion of US FDA consultation for DAS-40278-9 corn.

# DAS Supplied Materials Documents Supplied in Support of Draft EA Development
• Establish the ongoing regulatory activities and respective accountabilities of US
EPA and APHIS pertaining to DAS
- 40278 - 9 corn and 2,4
- D/ quizalofop 

### Regulatory Information:

• Regulatory Overview of 2,4
- D and Quizalofop

• Summary of 2005 2,4
- D Reregistration Eligibility Document (RED)

• GF
- 2654 TC US
- EPA Data Submission Letter

• Draft Label GF
- 2654 TC Submitted to US
- EPA

• GF
- 2727 TC Label Amendment

• US
- FDA Conclusion of Consultation Letter re: DAS
- 40278 - 9 Corn

# DAS Supplied Materials Documents Supplied in Support of Draft EA Development
• Detail the risk mitigating effect of DAS’ Product Stewardship Program and related proprietary technology Document Key Information Product Stewardship Information EnlistTM Weed Control System Stewardship Program Overview Stewardship program goals, components, education and training, compliance and reporting Stewardship of Herbicide Tolerant Trait Technology for DAS-40278-9 Corn Detailed description of Stewardship program goals, components, eduction and training, compliance monitoring EnlistTM Technical Bulletin Brief description of the Stewardship program Research Demonstrating Reduction in Potential Off-Target Movement for 2,4-D Choline and Colex-DTM Technology as Part of the EnlistTM Weed Control System Data demonstrating the characteristics of 2,4-D choline and Colex-D TM Technology relative the Stewardship program Draft Label GF-2654 TC Submitted to US-EPA Details of proposed label for 2,4-D choline including spray drift management and application directions.

# DAS Supplied Materials Documents Supplied in Support of Draft EA Development
• Detail the risk mitigating effect of DAS’ Product Stewardship Program and related proprietary technology Product Stewardship Information

• EnlistTM Weed Control System Stewardship Program Overview

• Stewardship of Herbicide Tolerant Trait Technology for DAS
- 40278 - 9 Corn

• EnlistTM Technical Bulletin

• Research Demonstrating Reduction in Potential Off
- Target Movement for 2,4
- D Choline and Colex
- DTM Technology as Part of the EnlistTM Weed Control System

• Draft Label GF
- 2654 TC Submitted to US
- EPA

# DAS Comments on EA

TMEnlist and Enlist Duo are trademarks of Dow AgroSciences LLC. Components of the Enlist Weed Control System have not yet received regulatory approvals; approvals are pending. The information provided here is not an offer for sale. ©2011 Dow AgroSciences LLC

# DAS Supplied Materials
DAS Comments to the DAS - 40278 - 9 Corn Docket
• Goal: Provide information relevant to issues being raised in the docket
• 3 comments submitted with attached documents

– APHIS
- 2010 - 0103 - 4933: Commitment to the Responsible Development and Use of the EnlistTM Weed Control System

– APHIS
- 2010 - 0103 - 5029: 2,4 - D and DAS
- 40278 - 9 Corn Not Associated with Agent Orange Health Controversies

– APHIS
- 2010 - 0103 - 5865, 66, 67, 68, 70, 71, 74, 75: DAS Comments to Docket (1 comment, 8 parts)

# DAS Supplied Materials
APHIS - 2010 - 0103 - 4933: **Commitment to the Responsible Development and Use of the EnlistTM Weed Control**  **System**

– Details risk mitigating effects of DAS’ technology and related product stewardship efforts

– Key aspects involve m inimizing the potential for off
- target movement of herbicide and promoting Weed Resistance Management (WRM) practices

– Farmer communication, outreach, training and education

# DAS Supplied Materials
APHIS - 2010 - 0103 - 5029: **2,4 -**  **D and DAS -**  **40278 -**  **9 Corn Not Associated with Agent Orange Health Controversies** 

– 

## 2,4 - D choline is not Agent Orange; 2,4
- D was not the focus of Agent Orange controversies

– 2005 , the U.S. EPA concluded that “ there is a reasonable certainty no harm will result to the general population or any subgroup from the use of 2,4
- D .”

– The dioxins of concern, 2,3,7,8
- TCDD and 1,2,3,7,8
- PeCDD have not been found in 2,4
- D produced by Dow AgroSciences

# DAS Supplied Materials APHIS - 2010 - 0103 - 5865, 66, 67, 68, 70, 71, 74, 75: DAS Comments to Docket (1 comment, 8 parts)

– Main body of the comment provides facts/citations and linkage to the DEA relevant to key areas identified during our assessment of docket comments
• Gene Flow
• Seed, Organic and Specialty Production
• Trait Stacking in Commercial Corn Hybrids
• Regulatory Oversight of Pesticides in the U.S.: The Role of US
- EPA
• Herbicide Resistance
• 2,4 - D Toxicity Issues
• Off
- Target Movement of 2,4
- D
• Quizalofop Summary

# DAS Supplied Materials APHIS - 2010 - 0103: DAS Comments to Docket (cont’d)

• Appendices provide factual material relevant to the deregulation process

– New Citation Inserts to DEA

– Research Demonstrating Reduction in Potential Off
- Target Movement

– EPA Human Health Risk Assessment (2,4
- D choline/DAS
- 40278 - 9)

– EPA Order Denying NRDC‟s petition to cancel 2,4
- D registrations

– Weed Resistance Management Media Articles

– Draft label for use of the 2,4
- D/ glyphosate pre - mix formulation on DAS
40278 - 9 corn.

– DAS Comments on APHIS’ PPRA

– Specific Comments on DAS
- 40278 - 9 Corn DEA

# DAS Supplied Materials

Additional Comment Analysis will be Provided in Near Future

• Focus on substantive comments with relevance to DAS
- 40278 - 9 corn

• Anticipated materials:

– Table summary of comments with reference to various documents in the record or other APHIS NEPA documents (e.g. RRSB FEIS)


### • Will provide specific direction to relevant information by document/page

– Increased herbicide application volume

– AAD
- 1 expression in pollen

– Herbicide synergy, multiple resistance development



### – Stewardship documents
• e.g. Technology Use Agreement, Stewardship Program

• If beneficial, data/documents submitted to EPA can be provided

# Thank You Components of the Enlist Weed Control System have not yet received regulatory approvals; approvals are pending. Enlist Duo is not yet registered for sale or use as a component of the Enlist Weed Control System. The information provided herein is not an offer for sale.

TM Enlist is a trademark of Dow AgroSciences LLC. © 2011 Dow AgroSciences LLC