September 11, 2012

Submitted Via Federal eRulemaking Portal

Docket No. APHIS-2012-0019 Regulatory Analysis and Development
Plant Protection Division
Animal and Plant Health Inspection Service United States Department of Agriculture
Station 3A-03.8
4700 River Road Unit 118 Riverdale, MD 20737-1238

Re: Preliminary Plant Pest Risk Assessment and Draft Environmental Assessment for Determination of Nonregulated Status of DAS-68416- 4 Soybean Genetically Engineered for
Herbicide Tolerance

To whom it may concern:

These comments are submitted by Dow AgroSciences LLC (DAS) in response to the July 13, 2012 announcement (the Notice) by the United States Department of Agriculture’s (USDA ’s) Animal and Plant Health Inspection Service (APHIS or the Agency) of APHIS’s preparation of a preliminary plant pest risk assessment and draft environmental assessment (EA) in connection with the proposed determination on the status of the DAS herbicide-tolerant soybean, designated
as DAS -68416-4 soybean, as a regulated article under the Plant Protection Act (PPA) and implementing APHIS regulations at 7 C.F.R. Part 340.

The relationship of the pending DAS-68416-4 soybean petition to the previously subm itted petition for a determination of non- regulated status for DAS -40278- 9 corn genetically engineered for herbicide tolerance should also be noted. In this context, the material submitted here relating to the herbicides 2,4 -D and glyphosate has relevance to the DAS-40278-9 corn
action .

DAS appreciates the opportunity to provide these comments for the Agency’s consideration.

Herbicide Tolerance: DAS’ new soybean product (DAS-68416-4 soybean) provides tolerance to the currently approved herbicide, 2,4-dichlorophenoxy acetic acid (2,4- D) allowing this
herbicide to be used on DAS-68416- 4 soybean 1 without damaging the crop. DAS-68416-4 soybean also provides tolerance to the approved herbicide glufosinate. 2,4-D has been used in
the United States since 194 8 to control broadleaf weeds. It is one of the most popular herbicides

1 Soybean expressing the 2,4

- D herbicide tolerance trait from DAS

- 68416

- 4 will be sold as EnlistTM soybeans.in use throughout the world and the most well-known and widely-used phenoxy auxin herbicide. 2,4-D is approved for use for weed control applications in soybean fields and with many ot her crops, on pastures and rangeland, and in both commercial and residential settings for weed control in parks, and on golf courses, lawns and other non- crop areas. Glufosinate was first approved for use in the United States in 2000. It is used to control broadleaf weeds in fields where many crops are grown including apples, berries, canola, corn, cotton, currants, grapes, grass grown for seed, potatoes, rice, soybeans, sugar beets, and tree nuts, as well as in non-crop

areas . DAS previously informed APHIS of the intention to stack DAS-68416- 4 soybean with a soybean that has been genetically engineered to be tolerant of glyphosate, thereby allowing growers the use of herbicide combinations or mixtures to control weeds.

DAS has developed a new form of 2,4- D, referred to as 2,4

- D choline, that has significantly less volatility than other 2,4-D products and a new product formulation designed to reduce the potential for spray drift. The combination of the ultra- low volatility of 2,4-D choline and the drift reduction properties of the new product formulation will reduce potential exposure to humans and the environment, as well as the potential for off-site movement and injury to neighboring crops that are sensitive to 2,4- D. Un der current commercialization plans, 2,4- D choline will be sold as a premix 2 with the herbicide glyphosate. This premix is currently intended to be the only 2,4-D formulation which Dow AgroSciences plans to market for use on
DAS -68416-4 soybean.

Draft EA and PPRA: The EA prepared by APHIS presents an extensive evaluation of thepotential effects on the quality of the human environment resulting from a determination of nonregulated status of DAS-68416-4 soybean. The EA is consistent with the Council of Environmental Quality’ s (CEQ) regulations implementing the National Environmental Policy Act (NEPA) (40 CFR Parts 1500-1508), and the USDA and APHIS NEPA implementing regulations and procedures (7 CFR 1b and 7 CFR Part 372). This evaluation is broad in s cope (addressing a number of issues including soy production, a comprehensive list of environmental considerations, public health considerations, animal feed and socioeconomic issues and threatened and endangered species), detailed, and thorough (240 pages of text, over 400 citations and 5 supporting Appendices).

The analysis in the EA shows that there are no potentially negative impacts (includingcumulative effects) on the environment of the Preferred Alternative (full deregulation of DAS68416- 4 soybean ) compared with the No Action Alternative. A potential benefit regarding reduced grower costs to control glyphosate resistant weeds identified for the Preferred Alternative was documented by APHIS in the EA (Section 4.8.1.2).

The draft Plant Pest Risk A ssessment documents that DAS -68416-4 soybean exhibits none of the characteristics of a plant pest – it is no more a plant pest than any other soybean line being grown commercially in the United States today. In addition, all of the herbicides that are lik ely to be used in DAS-68416-4 soybean fields, including 2,4- D, glufosinate and glyphosate (when DAS

68416-4 is stacked with a deregulated glyphosate tolerance trait), are in widespread use in U.S. and global agriculture and are routinely used for weed cont rol in major commodity crops grown

2 EnlistTM Duo Herbicide with Colex

- DTM Technology.for food and feed including soybean, crops rotated with soybean, or both. As discussed below, herbicides are regulated on an ongoing basis by the U.S. Environmental Protection Agency (EPA).

Regulatory Oversight/Status : As recognized by the Coordinated Framework for Regulation of Biotechnology, in effect since 1986, APHIS has sole authority and responsibility for the decision on whether or not to deregulate DAS-68416-4 soybean or any other herbicide-tolerant crop. Sepa rately, the EPA has sole authority and responsibility under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for the decision on whether or not to approve the use of 2,4- D on DAS -68416-4 soybean and, under Section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), to approve any food safety tolerances that may be necessary for residues of the herbicides in or on the crop and foods produced from the crops.

In order to approve the use of an herbicide or any other pesticide, EPA must fin d that it will not pose “any unreasonable risk to man or the environment.” For soybean and other food uses, EPA must find that any pesticide residues will be “safe”, defined as “a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.”

The primary means by which EPA addresses potential risk associated with pesticide use is the product label and it is a violation of federal law for any person to use a pesticide in a manner inconsistent with its labeling. In addition to being legally required to follow the directions for use that will appear on the label for the 2,4-D choline/glyphosate premix, all growers of DAS

68416- 4 soybean will be contractually obligated to follow all of the requirements in the DAS Technology Use Agreement and accompanying Product Use Guide.

2,4- D Safety: In 2005, EPA concluded an extensive registration review of 2,4- D an d concluded that, after stipulating minor label changes, 2,4-D met FIFRA’s no unreasonable adverse effects standard. Enlist Duo with Colex-D Technology containing the new 2,4-D choline, combined with DAS’ product stewardship program is designed to reduce the potential for off- target exposures to humans or the environment compared to other 2,4-D formulations currently on the market. Extensive comments on the favorable toxicological, eco-tox, and environmental profile for 2,4-D have been provided by recognized experts to the APHIS public docket for DAS-40278- 9 corn (APHIS-2010-0103-4529, 4532, 4898 and 4920) and are applicable to DAS-68416-4 soybean.

In 2009, Dow AgroSciences submitted its petition to APHIS (Number 09-349-01p) seeking a
determination that DA S-68416-4 soybean is “unlikely to pose a plant pest risk and, therefore, should no longer be a regulated article.” Separately, Dow AgroSciences has submitted anapplication to EPA to obtain approval for the use of its new 2,4-D choline formulation on DAS68416- 4 soybean. Following established EPA policy, it is expected that these applications will be approved only after APHIS makes a determination of non-regulated status for DAS-68416-4 soybean. The decisions to be made by APHIS and EPA are independent, statutorily enumerated actions. Finally, Dow AgroSciences has successfully completed a consultation with the U.S. Food and Drug Administration (FDA) concerning the safety of DAS-68416-4 soybean.Weed Resistance Management: DAS intends to cross-breed der egulated DAS -68416-4 soybeans with previously deregulated soybeans engineered to tolerate glyphosate. This commercialized “stacked” soybean will allow farmers to implement a robust integrated weed management (IWM) program utilizing multiple herbicides wit h differing modes of action. The use of differing herbicidal modes of action has been recommended by experts as a weed management strategy to help manage existing resistant weed varieties, and slow the development
of new resistance incidents. As correctl y noted in the EA, breeding a 2,4-D and glufosinate tolerant soybean (DAS -68416-4) with a glyphosate- tolerant soybean will allow growers to maintain methods and equipment already used with glyphosate-tolerant soybean, with the added ability to proactively manage weed resistance by using herbicides with multiple mechanisms of
action.

Resistance within weed populations can develop from repeated use of any single control practice.
This can result with nonchemical as well as chemical control methods when additional control practices are not employed. The wide -spread adoption of glyphosate-tolerant crops, along with the corresponding reduction in the use of other herbicides with differing modes of action, has resulted in the development of glyphosate- resistant an d hard- to -control weed populations. These weeds threaten the productivity and economical sustainability of farming operations and risk a return to increased tillage as a weed control method, with the resulting loss of the environmental
benefits offered th rough conservation tillage. The proposed use of Enlist Duo herbicide (a premix of glyphosate and 2,4- D) with DAS -68416-4 soybean offers a tool with multiple modes of action further strengthened by the historically low tendency for development of resistanc e to 2,4- D. The use of DAS -68416-4 soybean and Enlist Duo herbicide offers an effective tool to manage existing populations of glyphosate-resistant weeds and prevent the development of new resistant weed populations, while minimizing the potential for dev elopment of resistance to 2,4-
D. Greater awareness of the resistance issue by growers, researchers and regulators, combined with DAS’ comprehensive stewardship program that provides IWM guidance, will maximize these benefits. Furthermore, farmers will be able to retain current reduced till practices that maintain soil integrity and water quality, and reduced fuel costs associated with machinery use without compromising productivity.

Farmers, academics, and other members of the agricultural community sub mitted comments to
the DAS -68416-4 soybean public comment docket (APHIS-2012-0019) stressing the need for additional weed management technologies. These comments explain that DAS-68416-4 soybean and Enlist Duo will fit well with growers’ existing weed man agement programs, equipment and expectations (a small sample of the publicly

- available comments related to the need for this technology are APHIS -2012-0019, 0149, 0246, 0314, 0277 and 0201)

Coexistence : The processes currently in place to allow organic and non-GE soybean production to coexist with conventional soybean production growing GE soybeans would also apply to
DAS -68416- 4 soybean

.

Non -regulatory and regulatory processes are in place, allowing organic crops, crops which may be sensitive to pestic ides used in neighboring fields, and non- crop ecosystems to coexist with conventional soybean production. While these same processes would apply with the production
of DAS -68416-4 soybean, advances in both the herbicide technology and product stewardship

p rograms accompanying DAS -68416-4 soybeans and Enlist Duo herbicide further supportsuccessful coexistence. The Enlist Duo herbicide that will be used with DAS-68416- 4 soybean
features Colex -D Technology and contains the new 2,4-D choline. Field and laboratory results
demonstrate ultra

- low volatility with this new form of 2,4 -D, and the drift reduction properties built into the formulation greatly reduce potential for drift. The significant reduction in both volatility and drift greatly reduces the potential for off

- target movement. In addition, DAS will implement a product stewardship program that incorporates voluntary as well as legal and contractual obligations for the end user, along with education, training, and compliance monitoring programs. The combination of the technology and stewardship will allow conventional soybean producers growing DAS-68416-4 soybean to continue to coexist with nearby organic or other crops sensitive to 2,4-D and non- crop ecosystems.

DAS is committed to product stewardship for all of its products and has developed a multifaceted stewardship program for DAS-68416- 4 soybean that addresses the management of thecrop, the trait and the herbicides. The program involves training, signed grower agreements, onfarm monitoring and product use guides that will serve to maintain and foster coexistence of the diverse agronomic practices implemented by soybean farmers in the U.S. A key element of this program is that growers that choose to use 2,4-D are required to use DAS’ novel 2,4- D c hemistry and formulation technology that significantly reduces herbicide spray drift and volatility. Use of this technology will serve to bolster the existing EPA mandated herbicide label requirements designed to mitigate risks associated with off

- target impacts of 2,4-D on sensitive crops and noncrop plants/organisms.

Providing these benefits to growers through safe and effective technologies is a primary goal of DAS in the development of all our products including DAS-68416-4 soybean.

As set forth above and in the attached materials, the comprehensive review documented in the EA provides decision-makers and the public with a thorough evaluation of the potential environmental impacts associated with deregulating DAS -68416- 4 soybeans. DAS agrees with
AP HIS’ findings in the EA that there will be no significant effects on the human environment as a result of granting non- regulated status to DAS -68416-4 soybean and urges APHIS to issue a Finding of No Significant Impact and fully deregulate DAS -68416- 4 soyb ean.

• We find that APHIS’ EA and Plant Pest Risk Assessment relating to DAS -68416-4 soybean comprise a comprehensive evaluation of the potential effects on the environment associated with the full deregulation of DAS -68416-4 soybean. Based on its analyses, APHIS can reasonably conclude that full deregulation of DAS-68416-4 soybean would have no significant impact on the human environment.

• The EA provides a wide ranging and robust analysis of the potential environmental impacts of deregulating DAS-68416-4 so ybean.

• DAS seeks this opportunity to provide input on a few specific areas where additional supporting information could add clarity.
1. DAS -68416-4 soybean will not significantly affect non-GE, organic or specialty soybean production and will not require a change in soybean seed production practices for non- GE or GE seed.
2. In the EA, APHIS has appropriately identified EPA as having regulatory authority over the use of pesticides in the US and has considered EPA’s risk assessments of the potential environmental and health effects of 2,4- D,glufosinate and glyphosate used on DAS-68416-4 soybeans. In addition, APHIS has addressed the potential cumulative effects of new uses of 2, 4- D and glufosinate in conjunction with current usage, and has fully considered t he EPA risk assessment processes and decision -making standards under FIFRA
and FFDCA.
3. Through EPA approved label restrictions coupled with DAS’ comprehensive Stewardship Program deregulation of DAS-68416-4 soybean and its subsequent treatment with approved herbicides will not result in significant impacts to other sensitive crops or vegetation adjacent to DAS-68416-4 soybean.
4. Attached documents provide additional specific input on the EA, PPRA, 2,4- D (grower application, toxicology, manufacturing impurities, off- target impact), product stewardship and coexistence.

Dow AgroSciences appreci ates the opportunity to provide these comments and stands ready to provide any additional information that APHIS may require.

Sincerely,

Laura A. Tagliani

Regulatory Leader Regulatory Sciences & Government Affairs Dow AgroSciences LLC
9330 Zionsville Ro ad Indianapolis, IN 46268

# Dow AgroSciences LLC

Comments to Docket ID APHIS -2012-0019Page i TABLE OF CONTENTS

SECTION 1: STEWARDSHIP OF HERBI CIDE TOLERANT TRAIT TECHNOLOGY

FOR DAS -68416- 4 SOYBEAN AND ASSOCIATED HERBICIDE

PRODUCTS ........................................................................................................ 1

SECTION 2: ESTIMATE OF HERBICID E VOLUME AND IMPACT ON

ENVIRONMENTAL LOAD O F HERBICIDES WITH THE

INTRODUCTION OF ENLI ST  SOYBEAN (DAS -68416-4) ................... 26

SECTION 3: 2,4- D OFF

- TARGET EXPOSURE AND SENSITIVE CROPS .................. 40

SECTION 4: TRAIT STACKING IN COMMERCIAL SOYBEANS .............................. 49

SECTION 5: 2,4- D TOXICITY EVALUATIO N ................................................................. 58

S ECTION 5: A PPENDIX 1: EPA D ENIAL OF N OVEMBER 6, 2008 NRDC P ETITION TO
C ANCEL A LL 2,4-D R EGISTRATIONS (A PRIL 7, 2012) ............. 76

S ECTION 5: A PPENDIX 2: EPA O RDER D ENYING NRDC’ S P ETITION TO R EVOKE
T OLERANCES , 77 F ED

. R EG

. 23135 (A PRIL 18, 2012) .............. 87

SECTION 6: ANALYSIS OF 2,4

- D TECHNICAL ACID FOR THE PRESENCE OF

DIOXINS AND FURANS .............................................................................. 112

SECTION 7: ERRATA TO DRAFT PLAN T PEST RISK ASSESSME NT AND

ENVIRONMENTAL ASSESSMENT FOR DAS -68416- 4 SOYBEAN .... 117

S ECTION 7: A PPENDIX 1: N EW A PPLICATION W INDOW FOR 2,4-D C HOLINE ON DAS

68416-4 S OYBEANS F ALLS WITHIN THE T IMING AND R ATES OF
O THER 2,4-D U SES A PPROVED BY EP A ................................. 119

S ECTION 7: A PPENDIX 2: N ON

- GE S OYBEAN .................................................................. 124Page ii APPENDIX 1: CURRENT REGULATORY STATUS OF CERTAIN HERBICIDES

THAT MAY BE USED ON DAS -68416- 4 SOYBEAN ............................... 126

APPENDIX 2: 2,4- D CHOLINE FORMULATIONS AND U.S.

- EPA REGISTRATION

STATUS .......................................................................................................... 127

APPENDIX 3: LACK OF TOXICOLOGICAL OR BIOLOGICAL SYNERGISTIC

EFFECTS BETWEEN GLYP HOSATE AND 2,4 -D .................................. 128

APPENDIX 4: REPORT OF ISOLATED A UXIN RESISTANT WATER HEMP IN A GRASS SEED PRODUCTION FIELD; WEED CONTRO L SOLUTIONS

WITH MULTIPLE MODES OF ACTION WILL HELP ......................... 130

APPENDIX 5: ANALYSIS OF THE IMPA CT OF ENLIST ON HERB ICIDE USE ...... 132

REFERENCES:...........................................................................................142Pag e 1 S ECTION 1: STEWARDSHIP OF HERBI CIDE TOLERANT TRAIT

TECHNOLOGY FOR DAS -68416- 4 SOYBEAN AND ASSOCIATED

HERBICIDE PRODUCTS

Relevant to DAS -68416-4 Draft EA Section 4.2.2, 4.4.2, 5.1, 5.11, 5.14

Summary

Dow AgroSciences (DAS) has submitted a petition to the United States Department of Agriculture (USDA)’s Animal and Plant Health Inspection S ervice (APHIS) for the determination of non-regulated status for DAS-68416-4 soybean, which provides tolerance to the herbicides 2,4-dichlorophenoxy acetic acid (2,4-D) and glufosinate.

This document provides information pertaining to Dow AgroSciences’ comprehensive stewardship program for DAS-68416-4 soybean and its associated new herbicide technology, 2,4-D choline salt.Page 2 Stewardship of Herbicide Tolerant Trait Technology for DAS -68416-4 Soybean

and Associated Herbicide Products

Table of Contents

1. Introduction

______________________________________________________________________ 5

2. Stewardship Program Components

___________________________________________________ 5

2.1 Authorized Use of DAS

- 68416

- 4 Soybean and Associated Herbicide Products Through a Technology Use Agreement

________________________________________ 5

2.2 Herbicide Technology Advancements 6

2.3 Comprehensive Product Use Information 7

2.3.1 Product Use Guide

2.3.2 EPA Approved Product Labels Mandating Requirements and Restrictions

2.3.3 DAS

- 68416

- 4 Soybean Seed Packaging Information

2.3.4 Weed Resistance Management

2.4 Education and Tra ining for Distributors, Retailers, Growers and Applicators

_______ 10

2.5 Compliance Monitoring

___________________________________________________ 11

3. Stakeholder Outreach and Input

____________________________________________________ 12

4. Industry Commitment and Involvement

______________________________________________ 12

5. Conclusion

_______________________________________________________________________ 13

6. References

______________________________________________________________________ 14

Appendices

Appendix 1. Summary of Comprehensive Stewardship Program for DAS

- 68416

- 4

Soybean and Enlist Duo Herbicide

________________________________ _ 15

Appendix 2: Technology Use Agreement

________________________________________ 16

Appendix 3: Product Use Guide

_______________________________________________ 20Page 3 Stewardship of Herbicide Tolerant Trait Technology for DAS -68416-4 Soybean and
Associated Herbicide Products

Relevant to DAS -68416-4 Draft EA Section 4.2.2, 4.4.2, 5.1, 5.11, 5.14,

Readers Note: Throughout this document reference is made to Enlist Duo TM Herbicide, which is a proprietary blend of 2,4

- D choline and glyphosate dimethylamine salts. Dow AgroSciences has submitted to EPA for approval a proposed label for its Enlist Duo Herbicide with Colex

- D Technology, a pre

- mix of the new 2,4

- D choline salt and glyphosate dimethylamine. The first submission to EPA is for use on Enlist corn,
DAS

- 40278

- 9, and once approved then Dow AgroSciences will submit a label amendment for the use of Enlist
Duo on DAS

- 68416

- 4 soybean. Enlist Duo Herbicide cannot be offered for sale until the product receives registration by EPA.Page 4 1. Introduction

Dow AgroSciences is committed to promoting the responsible use and stewardship of its products throughout the product life cycle. Consistent with its existing stewardship programs and practices, Dow AgroSciences will implement comprehensive stewardship measures as part of the product launch for DAS-68416-4 soybean and associated herbicide products. The stewardship program will focus on educating and training retailers, growers and applicators on the appropriate use of DAS-68416-4 soybean and authorized herbicide products developed for use
with DAS -68416-4 soybean. This will be accomplished using a multi-faceted approach, involving a variety of tools and delivery methods and working with customers, stakeholders and industry organizations to promote responsible use. The stewardship program is designed to:

• Provide comprehensive guidance and education on responsible use

• Promote compatibility with other crops and cropping systems

• Minimize the potential for off

- target movement

• Promote Weed Resistance Management 3

• Promote responsible use and worker safety

• Support compliance with applicable regulatory requirements

2. Stewardship Program Components

The comprehensive stewardship program, as summarized in Appendix 1, is based on Dow AgroSciences’ ongoing commitment to stewardship and input from retailers, growers, applicators, regulators, and stakeholders. Key components of the stewardship program include:

• Authorized use of DAS-68416- 4 soybean and associated herbicide products through a Technology Use Agreement (TUA);

• Herbicide technology advancements;

• Comprehensive product use information, including mandatory use requirements and restrictions;

• Education and training for distributors, retailers, growers and applicator s; and

• Compliance monitoring.

2.1 Authorized Use of DAS-68416-4 Soybean and Associated Herbicide Products Through a Technology Use Agreement

Dow AgroSciences will authorize growers of DAS -68416-4 soybean through a Technology Use Agreement ( see Appendix 2 for TUA) that requires growers to use the soybean trait technology responsibly and prohibits the use of unauthorized herbicides. Dow AgroSciences currently requires growers to sign the TUA, which is a formal contractual agreement for responsible use of

3 Stewardship information on insect resistance management will also be included, as applicable.

TM Enlist and Enlist Duo are trademarks of Dow AgroSciences LLC.Page 5 its seed trait technology. In the case of DAS -68416-4 soybean, this contractual agreement will be expanded to include DAS -68416-4 soybean and its associated herbicide products.

The Technology Use Agreement is a legal and contractual obligation that will require all growers of Dow AgroSciences’ products containing the Enlist trait to:

• Use only EPA accepted and Dow AgroSciences’ authorized herbicide products as the only phenoxy carboxylic acid (e.g., 2,4- D) herbicides used for post -plant applications to
DAS -68416-4 soybean;

• Read and follow the Product Use Guide (PUG) requirements ( see Appendix 3 for an example of a draft of the Soybean PUG that will include information on the DAS -68416- 4 soybean, use of authorized herbicide products, and weed resistance management practices);

• Read and follow FIFRA pesticide product label directions, which will include requirements to use in a manner protective of the environment;

• Read and follow seed packaging information; and

• Provide access to information about use of the technology and allow on- farm

assessments.

Furthermore, the Technology Use Agreement provides Dow AgroSciences the right to revoke a grower’s access to DAS -68416- 4 soybean seed if stewardship requirements are not met.

2. 2 Herbicide Technology Advancements

Dow AgroSciences has discovered and developed a novel (non-ester or non- amine) 2,4-D choline 4 salt herbicide product for use with DAS-68416-4 soybean. The exceptionally low volatility of 2,4-D choline salt has been demonstrated in both laboratory studies and field studies. For example, in a laboratory study, wheat plants treated with rates ten t imes higher than specified on the label of 2,4-D choline were placed in an enclosed chamber with grape and tomato plants, which are sensitive to 2,4- D [ 1 ] . Aft er 24 hours of exposure in the chamber at 104°F, neither sensitive crop showed any symptoms of injury, which is typically characterized by leaf cupping, strapping, epinasty and twisting of the petiole and main stem of the plant. The lack of any symptoms on the grape and tomato plants is a clear indication of the highly reduced volatility of 2,4- D choline. Field results are consistent with these laboratory findings [ 2 ] . Trial s were conducted in 2010 and 2011 in Arkansas, Georgia, and Indiana to measure volatility differences between 2,4 -D ester, amine and choline forms under field conditions. The 2,4- D choline was six times less volatile than the DMA salt, which is considered essentially non

volatile, and twenty- four times less volatile than the ethylhexylester form [ 3 ].

Additionally, Dow AgroSciences has developed an innovative premix formulation, Enlist Duo TM Herbicide, that combines 2,4-D choline with glyphosate for use with DAS-68416- 4 soybean 5

. As compared to tank mixes of traditional 2,4-D products and commercial glyphosate, this premix

4 The United States Environmental Protection Agency (EPA) has accepted DAS’s submission for a wide range of crop and non

- crop herbicide uses for 2,4

- D choline salt. Registration for 2,4

- D ch oline salt’s use with DAS

- 68416 -4 soybean will be submitted to EPA for review.

5 Appli cations for 2,4

- D choline and associated herbicides for use with DAS 68416

- 4 soybean will be submitted to

EPA.Page 6 uses formulation technologies that will result in a significant reduction in herbicide off

- target movement from particle drift [ 4 ]. Field research has validated the observations from laboratory and wind tunnel studies. The drift reduction technology built into Enlist Duo Herbicide reduced
drift > 50% compared to a standard tank mix using conventional flat fan nozzles as well as advanced drift reduction nozzles. Compared to a conventional 2,4-D/glyphosate tank mix and flat fan nozzles, drift was reduced 90% when Enlist Duo Herbicide was combined with drift reduction nozzles [ 5 ]. The Product Use Guide will include recommendations on equipment (e.g. nozzles to minimize driftable spray droplets), calibration, use and maintenance.

A variety of factors including weather conditions (e.g., wind direction, wind speed, temperature, and relative humidity) and method of application can influence pesticide drift. The product label to be accepted by EPA will require users to evaluate these factors and make appropriate adjustments when applying Enlist Duo Herbicide for use with DAS-68416-4 soybean. The Product Use Guide will include information on environmental conditions such as wind speed and field temperature that will assist the herbicide applicator to minimize the potential for off

- target movement due to particle or vapor drift.

2.3 Comprehensive Product Use Information

2.3.1 Product Use Guide

Dow AgroSciences will provide DAS-68416-4 soybean growers a comprehensive Product Use Guide that is a material part of the Technology Use Agreement and details the requirements for responsible use. As a standard practice, Dow AgroSciences provides a Product Use Guide to users (e.g., retailers, dealers, growers, applicators) of its technology. The Product Use Guide provides growers comprehensive information including required and recommended management practices. The Product Use Guide for DAS -68416- 4 soybean will include detailed requirements for responsible use of the soybean and associated herbicide products. It will include information on weed resistance management, application and management of off -target herbicide movement, as well as seed planting direc tions and grain stewardship.

The Product Use Guide will require DAS-68416-4 soybean growers to:

• Use only EPA accepted and Dow AgroSciences’ authorized herbicide products as the only phenoxy carboxylic acid with Enlist soybeans

• Read and follow FIFRA pesticide product label directions

• Use properly maintained and calibrated ground application equipment for herbicide applications with minimum boom heights

• Use nozzles that produce a droplet size that meets the criteria specified on the authorized
herbicide lab el and reduce the potential for physical drift

• Follow instructions for equipment clean-out after product use

• Follow Weed Resistance Management guidelines, recommending utilization of herbicide products with additional modes of action

• Read and follow grain marketing guidelines

• Provide management practices to promote compatibility with other cropsPage 7 The Product Use Guide will promote appropriate cultural practices including diversified weed control strategies (e.g. herbicide use or crop rotation) to minimize selection for herbicide

resistant weed populations. Responsible use of the soybean seed and herbicides in an integrated farming system promotes compatibility with other crops.

2 .3.2 EPA Approved Product Labels Mandating Use Requirements and Restrictions

Dow AgroSciences has submitted to EPA for approval a proposed label for its Enlist Duo
Herbicide with Colex -D Technology, a pre-mix of the new 2,4-D choline salt and glyphosate dimethylamine. The first submission to EPA was for use on Enlist corn, DAS-40278-9, and onceapproved, Dow AgroSciences will submit a label amendment for the use of Enlist Duo on DAS68416-4 soybean. That label language will include detailed use directions and application requirements designed to minimize the potential for weed resistance development, minimize the potential for off-target movement, and promote worker safety.

The proposed Enlist Duo herbicide product label (2,4-D choline and glyphosate premix), to be submitted for EPA acceptance, will contain comprehensive information and requirements for responsible use for control of broadleaf weeds in DAS-68416-4 soybean. Pending EPA review and acceptance, these labels will specify use directions and requirements for spray drift and volatilization management designed to minimize the potential for misapplication or off- target movement of 2,4-D choline-containing herbicide products to agricultural and non- agricultural
land.

The Enlist Duo herbicide label will require herbicide applicators to:

• Follow all state and local regulations for application of herbicides containing 2,4- D

• Apply via ground application only

• Use properly maintained and calibrated ground application equipment with minimum boom heights

• Use drift reduction nozzles that produce a coarse or coarser droplet size

• Use an upwind setback from sensitive areas

• Adhere to wind speed restrictions on ground applications

• Avoid applications into areas of temperature inversion

• Follow instructions for equipment clean-out after product use

Dow AgroSciences will provide worker safety information in accordance with EPA requirements through herbicide product labeling, Product Use Guides, training and educational materials. Pending EPA review and acceptance, the Enlist Duo herbicide label will sp ecify the following typical Agricultural Use Requirements in accordance with the Worker Protection Standard:

• Do not enter or allow worker entry into treated areas during a restricted entry interval (REI) of 48 hours.

• Personal Protective Equipment (PPE) is required for early entry to treated areas permitted under the Worker Protection Standard and that involves contact with anything that has been treated, such as plants, soil, or water includes coveralls, chemical- resistant gloves made of any waterproof mate rial, shoes plus socks and protective eyewear.

In addition, the following information will also be included on the Enlist Duo herbicide label:Page 8 • Personal protective equipment for mixers, loaders, applicators, flaggers and handlers

• Engineering controls

• User safety recommendations

• First aid and emergency assistance

• Appropriate storage and disposal of pesticide and containers

In summary, Dow AgroSciences has submitted to EPA for approval a proposed label for its Enlist Duo Herbicide with Colex-D Technology for use on Enlist corn, DAS-40278-9, and onceapproved, Dow AgroSciences will submit a label amendment for the use of Enlist Duo on DAS68416- 4 soybean. The E nlist Duo herbicide product label will include comprehensive information and requirements for responsible use of Enlist Duo Herbicide with DAS -68416-4 soybean. Such label directions are designed to minimize the potential for weed resistance development, minimize the potential for off-target movement, and promote worker safety. In addition, the submitted label does not allow herbicide application through any type of irrigation equipment and prohibits aerial application.

2.3.3 DAS-68416-4 Soybean Seed Packaging Information

Packages of DAS -68416-4 soybean seed will have product stewardship information on the seed bags and seed tags, including use requirements and a customer information telephone number. Information will be included on seed packaging to communicate the presen ce of herbicide tolerant traits. This information will also be included in the Product Use Guide, training, and marketing materials.

2.3.4 Weed Resistance Management

Use of DAS -68416- 4 soybean with associated herbicides will enable growers to control weeds
that are hard

- to -control or resistant to glyphosate 6 . DAS -68416-4 soybean will provide an important alternative to glyphosate-only herbicide tolerant soybean by enabling the use of 2,4- D choline and glufosinate on this soybean for weed control.

Based on the mode-of- action classification system of the Weed Science Society of America, 2,4

- D is a Group 4 growth regulator herbicide (synthetic auxin). Some naturally occurring weed biotypes that are tolerant (resistant) to 2,4- D may exist due to genetic variability in a weed population. Where resistant biotypes exist, the repeated use of herbicides with the same mode of action can lead to the selection for resistant weeds. Certain agronomic practices reduce the

6 The following definitions are applied throughout this document: 1). Herbicide Tolerant Crop : A crop plant that

has been developed (using techniques such as genetic engineering or selection of variants produced by tissue culture or mutagenesis) to survive and reproduce after treatment with a specific herbicide or herbicides that would normally damage an unmodified crop; 2). Herbicide Resistant Weed: A herbicide

- resistant weed is a member of a population within a species that has an inherited ability to survive and reproduce following exposure to a dose of a herbicide normally lethal to susceptible populations of the species. Through repeated herbicide selection, the resistant population becomes dominant in a given area, and 3). Hard

- to

- Control Weed : A weed species that is inherently able to withstand treatment with a herbicide as a result of natural factors not involving herbicide selection or genetic mutation.Page 9 likelihood that resistant weed populations will develop and can be utilized to manage weed
resistance once it occurs.

Proactively implementing diversified weed control strategies to minimize selection for weed populations resistant to one herbicide or more is recommended by the Weed Science Society of
North America [ 6 ]. A diversified weed management program may include the use of multiple herbicides with different modes of action and overlapping weed spectrum with or without tillage operations and/or other cultural practices. Research has demonstrated that using the la beled rate and directions for use is important to delay selection for resistance.

To aid in the prevention of developing 2,4- D resistant weeds, Dow AgroSciences recommends the following practices for herbicide selection, crop selection and cultural prac tices, which are consistent with the recommendations of the Weed Science Society of America:

Herbicide Selection

• Rotate the use of Enlist Duo TM Herbicide with non-auxin (non-Group 4) and non- glycine (Group 9) herbicides

• Utilize a broad spectrum soil -applied herbicide as a foundation treatment

• Utilize herbicides with alternative modes of action

• Avoid using more than two applications of a Group 4 herbicide within a single growing season unless mixed with another mode of action herbicide with overlapping spectrum

• Apply labeled rates of Enlist Duo Herbicide at the specified time (correct weed size) to minimize escapes of tolerant weeds

Crop Selection and Cultural Practices

• Incorporate additional weed control practices whenever possible, such as delayed planting, crop rotation, mechanical cultivation and weed- free crop seeds, as part of an integrat ed weed control program

• Do not allow weed escapes to produce seeds, roots or tubers

• Thoroughly clean plant residues from equipment before leaving fields suspected to
contain resistant weeds

• Scout fields after application to detect weed escapes or shifts in weed species

• If resistance is suspected, treat weed escapes with an alternate mode of action or
cultivation

• Report any incidence of repeated non-performance of this product against a particular weed species to local retailer or Dow AgroSciences represe ntative

Such weed resistance management practices will be recommended in the Product Use Guide for Dow AgroSciences’ DAS -68416-4 soybean and Enlist Duo Herbicide to help preserve product efficacy and promote weed resistance management.Page 10 2.4 Education and Training for Distributors, Retailers, Growers and Applicators

Dow AgroSciences will provide comprehensive education and training in multiple formats to distributors, retailers, growers, and applicators to reinforce the requirements for proper
stewards hip and responsible use. Dow AgroSciences provides comprehensive training on its portfolio of products through a variety of formats. Education and training, reinforced through product profiles, technical bulletins, sales literature, direct mailing and websites will also be presented in multiple formats to enhance learning and mastery of core concepts related to the
Enlist TM stewardship program.

A variety of educational formats will be used to promote concept learning. Training will be provided through face- to

- face meetings, retailer visits, field visits, and self

- paced learning
modules on:

• Stewardship requirements for responsible use of DAS-68416-4 soybean and associated herbicides,

• Spray technology,

• Spray quality basics,

• Herbicide application, and

• Weed resistance management.

This training will reinforce the soybean grower’s obligation to adhere to product use guidelines, FIFRA Pesticide Product Labels, seed product information and all product stewardship requirements for responsible use and proper stewardship. Training is an ongoing process, with interactive learning incorporated, where applicable, to promote responsible use and stewardship.

Multiple resources and tools will be available to the growers and applicators to promote and communicate the impor tance of stewardship and responsible technology use. In addition to the Technology Use Agreement, Product Use Guide, and training, additional resources will be available, including:

• Customer Service

• Technical Bulletins

• AdvanceFarming.com

• On

- line training library

• In

- field experts

• Trait stewardship website (www.traitstewardship.com)

• Stewardship tools (e.g. nozzle selector, sensitive crop registries)

An extensive network of Dow AgroSciences sales representatives, field scientists, and agronomists will play an important role in educating and training retailers, growers and applicators on the proper use of the soybean seed, the herbicides and herbicide application guidelines. Dow AgroSciences’ field personnel, in addition to product suppliers, will work with growers to select the seed and herbicide products appropriate to their needs, growing conditions, and proper application equipment for field conditions.Page 11 2.5 Compliance Monitoring

Dow AgroSciences will monitor compliance with the Technology Use Agreement and Product Use Guide through surveys and on- farm assessments. Upon request by Dow AgroSciences,
DAS -68416- 4 soybean growers must provide information regarding the location of fields planted
with DAS -68416-4 soybean, and the herbicides applied to these fields.

Failure to follow the stewardship requirements will result in:

• Education and reinforcement of the stewardship requirements with growers, applicators and retailers,

• Additional education and training, and/or

• Loss of access to DAS -68416- 4 soybean.

3. Stakeholder Outreach and Input

Dow AgroSciences is using a variety of methods to obtain stakeholder input in the development of this stewardship program. Dow AgroSciences is consulting with retailers, growers and applicators to understand and address their needs in order to develop an effective and comprehensive stewardship program. In addition, Dow AgroSciences is proactively seeking input from recognized experts with a diverse range of experience in U.S. agriculture, as well as producers and processors of non-target crops. These efforts will support implementation of stewardship practices as broadly as possible throughout the value chain.

Dow AgroSciences will evaluate additional feedback from retailers, growers and applicators for the continuous improvement of this stewardship program following the launch of DAS-68416-4 soybean.

4. Industry Commitment and Involvement

Dow AgroSciences participates in several organi zations and associations globally to promote the safe research and development, production, distribution, and responsible use of agricultural chemical and biotechnology products.

Dow AgroSciences is a participant in the Herbicide Resistance Action Committee (HRAC) [ hracglobal.com ], an industry-based group supported by CropLife International [ croplife.org/public/resistance_management ]. HRAC focuses on encouraging responsible herbicide usage, communicating herbicide resistance management strategies and supporting their implementation through practical guidelines. HRAC engages in active collaboration with public and private researchers , especially in the areas of problem identification and devising and implementing herbicide management strategies.

Dow AgroSciences’ personnel interact with academic weed scientists in addressing weed resistance management [ wssa.net/Weeds/Resistance ] issues. Dow AgroSciences conducts joint trials at university sites as well as seeks input from university researchers regarding weed management. Dow AgroSciences also participates in a wide range of professio nal organizations including agronomy societies, seed trade groups, weed science societies, and crop commodity

groups.Page 12 In addition to managing the technology in accordance with the applicable requirements of federal and state government agencies, Dow AgroSciences is a Founding Member of the biotechnology industry’s Excellence Through Stewardship  organization, which encourages effective and comprehensive stewardship programs and quality management systems throughout a genetically engineered crop’s developmen t and commercialization.

5. Conclusion

Dow AgroSciences is committed to promoting the responsible use and stewardship of DAS68416-4 soybean and associated herbicide products. The comprehensive stewardship program outlined here incorporates elements to:

• Promote responsible use of DAS-68416-4 soybean and associated herbicide products,

• Promote compatibility with other crops,

• Minimize the potential for off -target movement of herbicide,

• Promote Weed Resistance Management, and

• Support compliance with all relevant state and federal requirements.

The stewardship program, focusing on education and management practices for proper use of the soybean and herbicides, coupled with the physical attributes of Enlist Duo TM (e.g., ultra- low volatility, minimized poten tial for drift, decreased odor and improved handling characteristics)enables coexistence with organic crops, crops traditionally sensitive to 2,4-D, and nongenetically engineered soybean.

Education and training efforts are also an integral part of the stewardship effort, promoting awareness and understanding of proper use of the soybean and herbicides. The combination of EPA mandated herbicide label requirements, Dow AgroSciences’ stewardship program, and associated proprietary herbicide technology will p rovide the grower of DAS-68416- 4 soybean with the tools needed to mitigate potential risk to the human health and the environment without compromising farm productivity.

 Excellence Through Stewardship is a registered trademark of Excellence Through Stewardship.Page 13 SECTION 1: APPENDIX 1. Summary of Comprehensive Stewardship Program for DAS

68416- 4 Soybean and Enlist Duo

**Proposed Enlist Duo TM**  **Herbicide FIFRA Pesticide Product Label:**

 Will require applicators to follow all state and local pesticide drift requirements regarding herbicide applications.

 Will not allow aerial or chemigation applications (i.e. ground application only).

 Will restrict ground applications at wind speeds less than or equal to 15 mph.

 Will require an applicator to assess whether a temperature inversion exists. Applications into areas of temperature

inversion will not be allowed.

 Will require using spray nozzles in accordance with manufacturer recommendations that produce a droplet s ize

classification of coarse or coarser (ASABE S

- 572 standard).

 Will require an upwind setback from sensitive areas based upon the combination of droplet size, wind speed and boom

height.

 Will require applicators to use extreme care when applying this product to prevent injury to desirable plants and crops.

 Will require use of properly maintained and calibrated ground application equipment with minimum boom heights

based upon nozzle manuf acturer’s recommendations.

 Will provide detailed instructions for sprayer and equipment clean

- out after product use.

**DAS**

**- 68416** 

**- 4 Soybean Access via Signed Technology Use Agreement:** 

 Will require growers to utilize Dow AgroSciences’ Authorized Herbicide as the only phenoxy carboxylic acid products

with DAS

- 68416

- 4 soybean.

 Will require growers to read and follow the Product Use Guide.

 Will require growers to read and follow FIFRA pesticide product labels.

 Will require growers to read and follow seed packaging information.

 Will require growers to provide Dow AgroSciences with access to information about soybean plantings and herbicide

use and allow on

- farm assessments.

 Will provide Dow AgroSciences right to revoke DAS

- 68416

- 4 soybean access if stewardship requirements are not met.

**Product Use Guide:**

 Will require growers to read and follow FIFRA pesticide product labels.

 Will require growers to utilize Dow AgroSciences’ Authorized Herbicides as the only phenoxy carboxylic acid products

with Enlist soybeans.

 Will require the use of nozzles that meet the criteria specified on the label that reduce the potential for physical drift.

 Will require growers to use properly maintained and calibrated ground application equipment for herbicide

applications with minimum boom heights.

 Will require technology users to follow instructions for equipment clean

- out after product use.

 Will require growers to follow Weed Resistance Management guidelines, recommending utilization of herbicide

products with additional modes of action.

 Will require growers to read and follow grain marketing guidelines.

 Will require growers to maintain records of planting locations of DAS

- 68416

- 4 soybean.

 Will provide management practices to promote compatibility with other crops.
**Education and Training for Distributors, Retailers, Growers and Applicators:**

 Will reinforce grower requirements to adhere to the Product Use Guide, FIFRA pesticide product labels, seed bag and

tag information, and stewardship requirements for responsible use.

 Will provide product guidance to retailers on responsible use to promot e proper stewardship.

 Will include responsible use of trait and herbicide technology, weed resistance management, spray technology and

stewardship requirements.

 Will include use of a variety of tools and delivery methods to reach distributors, retailers, growers and applicators.

TM Enlist and Enlist Duo are trademarks of Dow AgroSciences LLC. Some components have not yet received regulatory approvals; approvals are pending. The information provided here is not an offer for sale.Page 14 SECTION 1: APPENDIX 2. Technology Use Agreement

Following is an example of the current Technology Use Agreement that requires growers to use the technology responsibly and prohibits the use of unauthorized herbicides. The Technology Use Agreement is a legal and contractual obligation that details requirements for the technology

users.Page 15 1. DEFINITIONS : Each of the following terms shall have the meaning specified below:

• “Agreement” means , as of any date of determination, this Technology Use Agreement, and the then current (i) Product Use Guide(s) and (ii) Annual Technology Notification(s) for Purchased Seed, all of which are incorporated herein and deemed a material par t of this Agreement.
• “DAS” and “Dow AgroSciences” mean Dow AgroSciences LLC and its affiliated companies, the principle address of which is 9330 Zionsville Road, Indianapolis, IN 46268.

• “ DAS Authorized Herbicide Product(s)” means agricultural products that contain either phenoxy carboxylic acid or AOPP herbicides or both that are expressly labeled for use with EnlistTM crops and are specified in a Product Use Guide. Examples include products that contain 2,4

- D or quizalofop where the products are specifically labeled for use on EnlistTM crops.

• “ DAS Sou rced Technology(ies)” means proprietary germplasm and all current and future seed trait technologies relating to Purchased Seed as set forth in applicable PUG(s) and Annual Technology Notification(s). At the time of the execution of this Agreement, DAS Sou rced Technologies covered as Licensed Rights by this Agreement include, but are not limited to those listed in numbered paragraph 10 of this Agreement.

• “ Grower” means the individual farmer or farming entity identified in the Grower Information Box.

• “An nual Technology Notification” means a yearly communication to Growers with updated information regarding new and existing DAS Sourced Technologies, including (among other things) the U.S. patents licensed under this Agreement and any new or modified terms. The Annual Technology Notification(s) for Purchased Seed shall become a part of this Agreement, and Grower’s use of DAS Sourced Technologies following receipt of any Annual Technology Notification for Purchased Seed constitutes Grower ’s acceptance of all terms in the Annual Technology Notification.

• “Licensed Rights” mean all patent claims, trade secrets, rights existing under the US Plant Variety Protection Act (or its foreign equivalents), and other intellectual property rights relating to DAS Sourced Technology(ies) that are reasonably necessary for a Grower’s exercise of the limited license granted under numbered paragraph 2 herein with respect to Purchased Seed. The Licen sed Rights will be set forth in applicable PUG(s) and Annual Technology Notific ation(s)

• “Product Use Guide” and “PUG” mean the document(s) published and updated by DAS from time to time, which specify, among other things, stewardship management practices for Seed and DAS Authorized Herbicide Product(s). The PUG(s) for
Purchased See d shall become a part of this Agreement, and Grower’s use of DAS Sourced Technologies following receipt of any PUG constitutes Grower’s acceptance of all terms in the PUG.

“Purchased Seed” means Seed that is purchased by a Grower from a Seed Seller under a fully executed Technology Use Agreement to which Grower and DAS are parties.

• “Seed” means agricultural planting seed containing DAS Sourced Technologies sold by DAS Seed Sellers.

• “Seed Seller” means those entities authorized by DAS to sell Seed.

• “Third

- Party Trait Technology” means proprietary trait technology from a technology provider other than DAS.

2

. LIMITED LICENSE: Upon acceptance by DAS (or its authorized representative) of this Agreement, unaltered and duly executed by Grower, Grower is granted and hereby accepts, on and subject to the terms and conditions of this Agreement, a limited, non

transferable, revocable, non

- exclusive license by DAS under the Licensed Rights to purchase Seed from Seed Seller and to plant Purchased Seed to produc e a single commercial crop in the United States. In addition, when Grower purchases Seed and plants Purchased Seed containing Enlist Technology, Grower shall receive a limited license to apply DAS Authorized Herbicide Product s in Enlist crops grown from s uch Purchased Seed. This limited license only covers Grower’s activities in the United States and does not authorize Grower to plant Seed in the United States that has been purchased/acquired in another country or to plant Seed in another country that has been purchased/acquired in the United States. Grower acknowledges and agrees that Grower is NOT permitted: (1) to supply, transfer, license or sublicense any Seed or DAS Sourced Technology to any other person, entity or o ther third party for planting or a ny other purposes; (2) to save or use any seed produced from Seed for planting by Grower or any other third party; or (3) to use or allow others to use Seed or any plant material produced from Seed for crop breeding, seed production, research (including, w ithout limitation, agronomic testing or generation of comparative data against seed containing Third

- Party Trait Technology), or generation of regulatory approval data.

3. UPDATES ARE PART OF THIS AGREEMENT: Grower acknowledges and agrees the PUG, as updat ed and published from time to time by DAS, is incorporated herein and deemed a material part of this Agreement. For so long as Grower has a valid Agreement in effect with DAS, DAS will use reasonable efforts to provide Grower with the current PUG. Notwiths tanding the foregoing, Grower agrees that it is Grower’s responsibility to obtain and comply with the current PUG. The current PUG is ava ilable from authorized sellers of the Seed, from DAS directly and/or on one or more DAS websites. Grower’s use of Seed after DAS publishes a new PUG or updates a PUG constitutes Grower’s acceptance of and agreement to be bound by the provisions of
such new or revised PUG. Grower agrees to follow all Insect Resistance Management (IRM) requirements set forth in the PUG,
inc luding any to establish and maintain a refuge.Page 16 Grower also acknowledges and agrees that the Annual Technology Notification is incorporated herein and deemed a material part of this Agreement. For so long as Grower has a valid Agreement in effect with DAS, DAS will send an Annual Technology Notification to Grower at the address identified by Grower above. Grower’s use of Seed after DAS publishes a new Annual Technology Notification constitutes Grower’s acceptance of and agreement to be bound by the provisions of such new
Notification.

4. STEWARDSHIP AND COMPLIANCE:
• Grower agrees to read and follow all applicable PUGs and product labels associated with DAS Sourced Technologies and DAS

Authorized Herbicide Products.
• DAS Authorized Herbicide Products are the only phenoxy carboxylic acid and AOPP herbicides authorized for use with Enlist crops during any pre

- plant interval and after planting. When using a herbicide containing phenoxy carboxylic acid and/ or AOPP
herb icide with Enlist crops during any pre

- plant interval or after planting, Grower agrees to only use DAS Authorized Herbicide
Products.

• Grower agrees to provide Grower’s reasonable cooperation to DAS and its representatives and the representatives of any owner of DAS Sourced Technology (the “Representatives”) in connection with their efforts to verify Grower’s compliance with stewardship, IRM and other requirements hereof, including, but not limited to, completing written and oral questionnaires. Grower

a uthorizes the Representatives to enter upon land where Grower has planted or is growing Purchased Seed as well as any refuge area for purposes of examining the land and Grower’s crop and taking samples thereof. Grower authorizes the Representatives to

rev iew the USDA Farm Service Agency crop reporting information, including Form 578 and corresponding aerial photographs. Upon the request of the Representatives, Grower shall furnish copies of invoices for Grower’s purchase of the DAS Sourced Technology(ies) and DAS Authorized Herbicide(s), and Grower will disclose to the Representatives certain information to confirm compliance with this Agreement, including the locations of all fields planted with crops containing DAS Sourced Technology(ies),
the identities of all herbicides applied to these fields, and other data as specified in the PUG(s).

5. TERM AND TERMINATION: This Agreement, once signed by Grower and accepted by DAS, will remain in effect until terminated or superseded. Grower or DAS may terminate thi s Agreement at any time for any reason by sending notice of termination to the other party at the address specified above. In addition to the foregoing, DAS reserves the right to revoke Grower’s right to use one or more particular DAS Sourced Technology(ie s) upon notice to the Grower. In the case of termination by Grower, such notice of termination must include Grower’s full name and address. Upon termination of this Agreement for any reason, Grower will no longer have a right to purchase or use Seed; howev er, Grower’s obligations and DAS’ rights that arose under the Agreement prior to termination will continue in effect.

6. TRAIT FEES: Grower agrees to timely pay DAS or its designated representative all applicable fees that are a part of, associated
with or collected with the purchase and use of any Seed and/or DAS Sourced Technology upon DAS’ payment terms then in effect. DAS reserves the right to change from time to time the amount of and how it charges technology fees. Grower shall pay interes t to
DAS o n any past

- due technology fees at the rate of 1.5% per month (18% per annum) or the maximum amount permitted by law, whichever is less, from the applicable due date for such fees until paid. Any payments received by DAS may be applied to unp aid fees, inte rest or other charges in DAS’ discretion.

7. LIMITATIONS OF WARRANTIES AND REMEDIES: DAS warrants that the DAS Sourced Technologies licensed hereunder conform to the written description in the current PUG and the Seed bag or Seed tag affixed to the unit of seed containing DAS Sourced Technology. This warranty applies only to the DAS Sourced Technologies contained in Seed that has been purchased from
a Seed Seller.

THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE WHICH ARE HEREBY

DISCLAIMED.
Because DAS must have sufficient time to investigate any claim regarding the performance or non

- performance of Seed and/or DAS Sourced Technology, no claim can be asse rted against DAS unless Grower gives notice to DAS within fifteen (15) days after Grower first observes indications that the performance of the Seed and/or DAS Sourced Technology is not as warranted.

GROWER’S EXCLUSIVE REMEDY FOR ANY CLAIM OR LOSS, INCLUDING, WITHOUT LIMITATION, CLAIMS ALLEGING STRICT LIABILITY OR NEGLIGENCE, SHALL BE LIMITED TO REPAYMENT OF THE AMOUNT OF THE PURCHASE PRICE FOR THE AFFECTED SEED. IN NO EVENT SHALL DAS, ITS AFFILIATES, DEALERS OR LICENSEES BE LIABLE FOR ANY INCIDENTAL, SPEC IAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH THE

SEED.Page 17 8. THIRD

- PARTY TRAIT PROVIDERS:

• Grower acknowledges and agrees this Agreement is entered into for the benefit of Third

- Party Trait Technology providers to
the extent their trait technologies are licensed as DAS Sourced Technologies hereunder and, as third

- party beneficiaries, these
Third

- Party Trait Technology providers are entitled to enforce the provisions of this Agreement, as they may pertain to their respective trait technologies, against Grower, including maintaining a legal action directly against Grower.

• In the case of some Third

- Party Trait Technology contained in the Seed and identified in the PUG, Grower may be required to
obtain a limited license to use such technology directly from the owner of such Third Party Trait Technology.

9. ADDITIONAL PROVISIONS:
• Grower agrees to communicate all applicable terms, conditions and restrictions on Seed whether under this Agreement, a PUG, an Annual Technology Notification or otherwise to all persons and entities possessing or taking an interest in Grower’s Seed and grain
therefrom.
• Grower agrees that should any information provided to DAS herein change, Grower will promptly provide DAS with Grower’s updated informati on at the DAS address provided above.
• Grower’s rights under this Agreement may not be transferred or assigned to any other person, entity or third party without the
written consent of DAS.
• This Agreement (including PUGs and Annual Technology Notificat ions) constitutes the entire agreement between Grower and DAS regarding the subject matter hereof and all prior agreements between Grower and DAS with respect to the subject matter hereof are superseded.
• If any provision in this Agreement is determined t o be void or unenforceable, the remaining provisions shall remain in full force
and effect.
• The failure of DAS or any Third

- Party Technology providers to exercise one or more of its rights under this Agreement on one or
more occasions shall not be deemed a waiver to exercise such right(s) on one or more subsequent occasions.
• Governing Law: This interpretation and enforcement of this Agreement shall be governed by the laws of the State of Indiana without regard to its choice of laws provisions.

• Enforce ment Costs: Grower agrees that DAS and any owners of the patents covered by this Agreement shall be entitled to recover any costs or expenses, including, but not limited to, court costs or reasonable attorneys fees, it incurs in enforcing its ri ghts under this Agreement.

10. CURRENT DAS SOURCED TECHNOLOGIES INCLUDE :

• Herculex ® I Insect Protection

• Herculex ® RW Rootworm Protection

• Herculex ® XTRA Insect Protection

• WideStrike ® Insect Protection cotton

• SmartStax ® corn

• Refuge Advanced ® powered by SmartStax ®

• EnlistTM Weed Control System

• Agrisure ® CB/LL corn

• Agrisure ® GT corn

• Agrisure VipteraTM corn

SmartStax multi

- event technology developed by Dow AgroSciences and Monsanto. Herculex Insect Protection technology by Dow AgroSciences and Pioneer Hi

- Bred. Herculex, WideStrike, Refuge Advanced and Enlist are trademarks of Dow AgroSciences LLC. SmartStax is a trademark of Monsanto Technology LLC. Agrisure and Agrisure Viptera are trademarks of a Syngenta Group Company. Always follow grain marketing and IRM requirements and pesticide label directions. Bt and Enlist products may not be registered in all stat es. Check with your seed representative for the registration status in your state. ©2012 Dow AgroSciences LLC.Page 18 SECTION 1: APPENDIX 3. Product Use Guide

Following is a draft Product Use Guide that includes information on Enlist soybeans, herbici de product use, and weed resistance management practices which will be finalized prior to product
launch.



# Dow AgroSciences



# Product Use Guide

for Enlist TM 

# Soybean sPage 19 

## Stewardship Overview

Dow AgroSciences is committed to promoting the responsible use and stewardship of its products throughout the product life cycle. Consistent with its ongoing stewardship programs and practices, Dow AgroSciences has implemented comprehensive stewardship measures for EnlistTM soybeans and the herbicides that are part of the EnlistTM Weed Control System and Enlist soybeans.

This Product Use Guide (PUG) details requirements and recommendations for the planting of Enlist soybeans and the proper use of Enlist DuoTM herbicide featuring Colex -D TM Technology. This Product Use Guide is not a pesticide product label. It is intended to provide additional information and to highlight approved uses from specific product labels. Read and follow all precautions and directions on the product labels and any supplemental labeling for Enlist Duo herbicide featuring Colex

- D Technology, Dow AgroSciences Authorized Herbicide Product(s), as well as any other pesticide products. As a grower planting Enlist soybeans, you must be both familiar with and follow the T echnology Use Agreement (Agreement) and this associated Product Use Guide.



## Dow AgroSciences’ Technology Use Agreement

NOTE: YOU MUST HAVE A VALID, EXECUTED TECHNOLOGY USE AGREEMENT ON FILE WITH DOW AGROSCIENCES TO LEGALLY OBTAIN, PLANT AND GROW SOYBEANS T HAT CONTAIN DOW AGROSCIENCES’ ENLIST TRAIT.

Failure to comply with the terms of the Agreement or this PUG can result in your losing the privilege to grow seed containing the Enlist technology. You must communicate all applicable terms, conditions and restrictions on your EnlistTM soybeans to all persons and entities possessing or taking an interest in your EnlistTM soybean crop and/or the grain therefrom. You may complete the Agreement online at
tra itstewardship.com or obtain a copy by calling 877 -4- TRAITS (877

- 487

- 2487) or contacting your seed provider.

By signing the Agreement, you receive a limited

- use license for commercialized, authorized Enlist soybean seed, and to apply Dow AgroSciences’ Authorized Herbicide Products. You will also receive the most current PUG and other periodic updates relating to Enlist soybeans.

By purchasing and using Dow AgroSciences technologies and traits under the Agreement, you reaffirm your commitment to the Agreement you signed, and to follow this PUG and herbicide product labels. The seed you purchase is for your use and cannot be given, sold or otherwise transferred to others who have not signed an Agreement and for which you have not informed Dow AgroSciences of such transfer. In addition, you cannot transfer Dow AgroSciences technologies and traits to anyone outside of the United States.



## Compliance Monitoring

Dow AgroSciences will monitor compliance with the Agreement and Product Use Guide through surveys
and on

- farm assessments. Upon request by Dow AgroSciences, growers must provide information regarding the location of fields planted with Enlist soybeans and the herbicides applied to these fields. Failure to follow these stewardship requirements may result in additional education and training, monitoring, and/or loss of access to the technology.Pag e 20 

## Enlist TM 

## Soybean Varieties

Dow AgroSciences continues to collaborate with leading soybean breeding programs to develop high

- yielding EnlistTM soybean varieties for growers. Enlist soybeans confer tolerance to 2,4

- D and glufosinate, and are stacked with the glyphosate trait. This offers growers the benefits of tolerance to in

- crop applications of Enlist Duo and other Dow AgroSciences’ Authorized Herbicide Product(s) t o reduce weed competition

. 

## Coexistence

Soybeans are a naturally self

- pollinated crop. If the grower desires to use or market this crop separately from general commodity use, fields should be planted at a sufficient distance away from other crops to prevent cross

- pollination and mechanical mixture during harvest. 

## Crop and Grain Marketing Stewardship

Dow AgroSciences is a member of Excellence Through Stewardship ® (ETS). Dow AgroSciences’ products are commercialized in accordance with ETS product launch stewardship guidance, and Dow AgroSciences’ Product Launch Stewardship Policy.

Direct grain produced from Enlist soybeans to appropriate markets as necessary. Any crop or material produced from this product can only be exported to, or used in, processed in or sold in countries where all necessary regulatory approvals have been granted. It is a violation of national and international law to move material containing biotech traits across boundaries into nations where import is not permitted. Talk to your grain handler or product purchaser to confirm their buying position for this product.

For further information about your crop marketing options, contact Dow AgroSciences at 877 -4- TRAITS (877

- 487

- 2487). Information regarding the regulatory and market status of agricultural biotechnology products can be found at: biotradestatus.com.


## Weed Management

Repeated use of herbicides with the same mode of action can lead to selection for resistant biotypes within the larger population of weeds. The key to controlling existing resistant weeds and slowing the development of new resistant weeds is to diversify and reduce selection pressure on the weed population while still maintaining high levels of weed control that limit weed seed production.

Diversification of weed management strategies can be accomplished by integrating several proven practices for weed control, such as:

1. Rotate crops and cultural practices to allow for a wider range of weed control practices.

2. Start with a clean field, using either a burn

- down herbicide application or tillage and scout fields before and after herbicide application.

3. Use the correct herbicide product at the right rate and time and apply herbicide mixtures with different modes of action.

4. Control weeds early when they are relatively small. Rotate herbicides that have different modes of action and use residual herbicides that have different modes of action.

5. Use new commercial, weed

- free crop seed and clean equipment before moving from field to field to minimize spre ad of weed seed.

6. Control weed escapes and prevent weeds from setting seeds. Incorporate other herbicides and cultural practices as part of the herbicide

- tolerant cropping systems where appropriate.Pag e 21 

## Use of Enlist DuoTM Herbicide with EnlistTM Soybeans

Enlist soybeans contain patented genes that provide tolerance to 2,4

- D, and glufosinate. Enlist soybeans are also stacked with the glyphosate trait. Enlist Duo herbicide contains the active ingredients 2,4

- D choline and glyphosate dimethlyamine.

Enlist DuoTM Herbicide with Colex

- DTM Technology

Crop Enlist Soybeans Active Ingredients 2,4

- D Choline and Glyphosate DMA

Modes of Action Group 4 and Group 9

Formulation Soluble Liquid Signal Word Warning

Use Rate in

- Season Applications within the anticipated range of use rates: 2.5 – 4.75 pt/A

Surfactants/Oils Not Recommended Application Timing Post

- emergence to weeds Sprayer Nozzles Coarse or Very Coarse spray Spray Volume 10

- 15 gpa

Rain Fast Heavy rainfall soon after application may wash off this product from the foliage. A repeat application may be required for adequate control. *Read the Product Label for complete details



## Weed Control with Enlist Duo Herbicide

The lower dosages given on the Enlist Duo label will be satisfactory for young, succulent growth of sensitive weed species. For less sensitive species and under conditions where control is more difficult, the higher dosages will be needed. Apply Enlist DuoTM when weeds are young and actively growing, per the label directions.

The product label for Enlist Duo contains the approved directions growers must follow for products labeled for use over Enlist crops including but not limited to: weed management information, application equipment requirements, product use directions, restrictions and precautions, and other product information.Pag e 22 

## The Program Approach

A program approach including Enlist Duo herbicide aids in the management of weed resistance, reduces weed competition during critical crop growth stages and improves the overall consistency of weed control. It eliminates competition from a broad spectrum of early season grass and broadleaf weeds. The mode of action classification system of the Weed Science Society of America (WSSA) lists 2,4

- D as a Group 4 growth regulator herbicide (synthetic auxin) and glyphosate as a Group 9 herbicide (inhibitor of ESP P synthase).

• The recommended weed control program for EnlistTM soybeans is a PRE application herbicide product containing at least two non

- Group 4/Group 9 modes of action, followed by a POST application of Enlist Duo herbicide. If a second POST application of Enlist Duo is required, it must occur at least 12 days after the first application, per the product label.

Read and follow product label, as well as follow state and local requirements related to application of pesticides.


## Drift Managemen t

Susceptible Plants

Do not apply under circumstances where spray drift may occur to food, forage, or other plantings that might be damaged or crops thereof rendered unfit for sale, use or consumption. Avoid contact of herbicide with foliage, green stems, exposed non

- woody roots of crops, desirable plants and trees because severe injury or destruction may result. Small amounts of spray drift that may not be visible may injure susceptible broadleaf plants. Before making an application, please refer to your state’s sensitive crop registry (if available) to identify any commercial specialty or certified organic crops that may be located nearby. Commercially grown tomatoes and other fruiting vegetables (EPA crop group 8), cucurbits (EPA crop group 9), and grapes are particularly sensitive to drift from this product. Do not apply when wind direction favors off

- target movement onto these crops.

Apply Enlist DuoTM herbicide only with properly calibrated ground application equipment using appropriate carriers. Boom Height

To minimize spray drift potential, use the minimum nozzle height recommended by the nozzle manufacturer based on configuration of the spray boom. Spray Volume

Use a spray volume of 10

- 15 gallons or more per acre for ground equipment and apply with calibrated ground equipment. Do not apply less than 10 gallons total spray volume per acre. Where applicable, state regulations specifying minimal spray volumes must be observed.

In general, increase spray volume as crop canopy, height and weed density increase to obtain adequate
spray coverage.
Nozzle Selection

Proper spray nozzle selection plays a critical part in minimizing the potential for physical drift. Use low drift nozzles, according to the American Society of Agricultural and Biological Engineers (ASABE) S

- 572 standard, that produce a coarse to very coarse spray and are designed for herbicide application. Ultra coarse droplet sizes may result in decreased weed control and increased crop injury.Pag e 23 Wind Speed

Drift potential is lowest at wind speeds less than 10 mph. Target applications at wind speeds greater than 3 mph but less than 10 mph. Do not apply at wind speeds greater than 15 mph.

The product should not be applied at wind speeds less than 3 mph where temperature inversion or sta ble atmospheric conditions could exist.
Temperature and Humidity

When making applications in low relative humidity, set up equipment to produce larger droplets to compensate for evaporation. Droplet evaporation is most severe when conditions are both hot and dry.

Setbacks

Setbacks for Enlist DuoTM herbicide are directional meaning they would only apply downwind of the spray application . Apply this product only if the wind direction favors on

- target deposition and there are no sensitive areas (including residential areas, bodies of water, known habitat for non

- target species,

non

- target crops) within 250 feet downwind. Local terrain can influence wind patterns. The applicator should be familiar with local wind patterns and how they affect drift.

Setback Distances: [Distances will not be finalized until EPA label is approved]

Setback Distance*: Allow setbacks (buffer zones) upwind of sensitive area (e.g., residential areas, bodies of water, known habitat for threatened or endangered species, and sensitive non

- target crops other than those listed above) according to the following: Wind Speed (mph) Spray Boom <24 Inches Above Canopy (ft) Spray Boom >24 Inches Above Canopy (ft)
<5 [pending regulatory approval] 5

– 10
10

– 15 *If a coarse or very coarse droplet classification cannot be maintained, an upwind setback of 250 feet from sensitive areas must be observed. 

## Mixing Instructions

This product mixes readily with water. Mix spray solutions of this product as follows:

1. Fill the mixing or spray tank with the required amount of clean water. If addition of ammonium sulfate is desired to enhance performance of the product, see the Ammonium Sulfate section of the herbicide product label.

2. Add the specified amount of this product near the end of the filling process and mix well. During mixing and application, foaming of the spray solution may occur. To prevent or minimize foaming, use a commercial defoamer or avoid the use of mechanical agitators, and/or terminate by

- pass and return lines at the bottom of the tank.

Note : Use approved anti

- back siphoning devices where required by state or local regulations to avoid siphoning back into the carrier source.

Adjuvants (except Ammonium Sulfate)

Enlist Duo contains drift control technology. The use of adjuvants and drift control additives with Enlist Duo herbicide with Colex

- D Technology can have a negative impact on stability and application performance. The addition of some adjuvants may result in increased crop injury, decreased weed control, and/or increased potential for spray drift.

If an adjuvant or drift control additive is desired, it must be tested for compatibility with Enlist Duo herbicide.Pag e 24 Tank Mixing with Other Products

Some herbicides, fungicides, micronutrients and insecticide products may require drift management and application settings that differ from Enlist DuoTM herbicide. Additionally, the formulation components of some products may contain inert ingredients that negatively affect the low

- drift properties offered with Enlist Duo with Colex

- D Technology. If these settings are in conflict with the management recommendations in this Product Use Guide, these products cannot be tank

- mixed with Enlist Duo herbicide.

Restrictions

Refer to the label for specific planting restrictions, weed height and use information for annual and perennial weeds. During the growing season following application, do not replant fields with crops other than those labeled for use with 2,4

- D and glyphosate. 

## Recordkeeping

As part of good farm management practices, maintain detailed spray records, including:

• Field location and number of acres sprayed

• Date of application, start time, and finish time

• Herbicide sprayed and application rate

• Nozzles used and operating p ressure

• Travel speed and application rate

• Air temperature and relative humidity

• Wind speed and direction

• Sprayer and boom cleanout 

## Sprayer and Equipment Cleanout

To avoid injury to desirable plants, properly clean equipment used to apply this product before reuse or using the equipment to apply other chemicals.

If the crop following the application of Enlist Duo is an application to glyphosate

- tolerant corn: rinse the spray equipment with clean water to at least 10 percent of the total tank volume and spray the solution out of the spray tank through the boom.

If the application immediately following Enlist Duo is to any other crop, use the triple

- rinse sprayer cleanout procedure for Enlist DuoTM herbicide below:

• Completely drain the spray system, including lines and spray boom, for at least five minutes.

• Fill the container with clean water to at least 10 percent of the total tank volume and circulate the solution through the entire system so that all internal surfaces are contacted for at least 15 minutes to complete the first rinse of the application equipment. Spray the solution out of the spray tank through
the boom.

• Completely drain the spray system, including lines and spray boom, for at least five minutes; remove and clean filters and str ainers.

• Fill the container with clean water to at least 10 percent of the total tank volume. During the second rinse, tank cleaning agents may be added at the manufacturer’s recommended rates. Circulate the solution through the entire system so that all internal surfaces are contacted for at least 15 to 20 minutes.

• Completely drain the spray system, including lines and spray boom, for at least five minutes.

• Fill the container with clean water to at least 10 percent of the total tank volume and circulate the solution through the entire system so that all internal surfaces are contacted for at least 15 minutes to complete the third rinse of the application equipment. Spray the solution out of the spray tank through
the boom.

• Completely drain the spray system, remove nozzle tips and strainers and clean them separately.Pag e 25 

## Resources

• Enlist website: Enlist.com

• Trait Regulatory and Mar ket Status: biotradestatus.com

• Trait Stewardship: traitstewardship.com

• Weed Resistance Assessment Tool: weedtool.com/

• Weed Resistance Management Training: soygrowers.com/WRM/default.htm



## Contact Us

If you have questions about proper handling and use of these products or if you become aware of potential misuse or incidents involving these products, please call 877 -4- TRAITS(877

- 487

- 2487).



## Stewardship

Dow AgroSciences is a founding member of Excellence through Stewardship ® and is a Responsible Care ® Company.



## Patent Statement

This Seed is protected under one or more U.S. patents. Grower is provided a limited license under the Technology Use Agreement to purchase Seed from Seed Seller and to plant Purchased Seed to produce a single commercial crop in the United States. Grower is NOT permitted: (1) to supply, transfer, license or sublicense any Seed or Dow AgroSciences’ Sourced Technology to any other person, entity or other third party for planting or any other purposes; (2) to save or use any seed produced from Seed for planting by Grower or any other third party; or (3) to use or allow others to use Seed or any plant material produced from Seed for crop breeding, seed production, research (including, without limitation, agronomic testing or generation of comparative data against seed containing Third

- Party Trait Technology), or generation of regulatory approval data.



## Trademark Statement

®TM Colex

- D, Enlist and Enlist Duo are trademarks of The Dow Chemical Company (“Dow”) or an affiliated company of Dow. ® The Roundup Ready 2 Yield Logo is a registered trademark of Monsanto Technology LLC. Always follow weed resistance management, grain marketing and all other stewardship practices and pesticide label directions. Roundup Ready crops contain genes that confer tolerance to glyphosate herbicides. Glyphosate herbicides will kill crops that are not tolerant to glyphosate. B.t. products may not yet be registered in all states. Check with your seed representative for the registration status in your state. ® Excellenc e Through Stewardship is a registered trademark of Biotechnology Industry Organization. ® Responsible Care is a registered service mark of the American Chemistry Council. Components of the Enlist Weed Control System have not yet received regulatory approval s; approvals are pending. The information presented 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.Page 26 SECTION 2: ESTIMATE OF HERBICID E VOLUME AND IMPACT ON

ENVIRONMENTAL LOAD O F HERBICIDES WITH THE

INTRODUCTION OF ENLI ST  SOYBEAN (DAS -68416-4)

Summary

Dow AgroSciences (DAS) has submitted a petition to the United States Department of Agriculture (USDA)’s Animal and Plant Health Inspection Service (APHIS) for the determination of nonregulated status for DAS-68416-4 soybean, which provides tolerance to the herbicides 2,4-dichlorophenoxy acetic acid (2,4-D) and glufosinate.

The deregulation of DAS-68416-4 soybean will usher in a new era of weed control by improving existing weed control practices and introducing new modes of action in soybean production.
S oybean varieties containing the DAS -68416- 4 trait will be crossed with soybean varieties that
contain a glyphosate- tolerant trait to produce a breeding stack . Thus, the commercially offered varieties will have tolerance to 2,4

- D, glufosinate and glyphos ate. Various scenarios based on different input assumptions have been constructed to estimate potential volumes of 2,4- D, glyphosate and glufosinate on commercial soybeans that contain DAS-68416-4 and other
herbicide tolerant traits. These scenarios cover the range of realistic, expected use patterns based on an understanding of market dynamics and DAS breeding development options. The results of this analysis show, that w hen actual use patterns and market dynamics are taken into consideration, the increa sed volume of 2,4- D in soy will be a 6-9 fold increase, with an extremely conservative estimate of 14 fold. This is in sharp contrast to speculations that have been cited publicly which claim increases of hundreds to even thousands fold, but are based on speculation and not an understanding of true market and herbicide use dynamics. Recent studies indicated that other available herbicide use would increase similarly to what is projected for 2,4

- D if DAS -68416-4 soybean is not available to help control glyphosate-resistant and other hardto -control weeds.

The projected environmental loading of herbicide use in response to the growing emergence of glyphosate- resistant weeds as previously discussed is reviewed. Additionally, the ecological
assessment of pesticides in light of new projected volumes is addressed from a regulatory perspective.Page 27 Estimate of Herbicide Volume and Impact on Environmental Load of
Herbicides with the Introduction of Enlist soybean ( DAS -68416-4 )

Relevant to DAS -68416- 4 Draft EA Section 4.4.2, 5

Executive Summary

The introduction of DAS-68416-4 soybean (Enlist TM soybean) and Enlist Duo TM herbicide will bring a much needed new herbicide tolerant trait and vastly improved herbicide technology into American agriculture. The new cr op trait offers tolerance to 2,4- D as well as tolerance to the herbicide glufosinate , combining proven broadleaf weed control with a new mode of action for control of problem weeds in soybean. The new trait will be stacked with existing glyphosate
toleran ce traits to enable the continued use of the extremely popular and beneficial glyphosatetolerant technology and help control existing populations of glyphosate-resistant and hard- to

control weeds and prevent further emergence of glyphosate- resistant weeds.

To accompany this new crop trait technology a new herbicide offering, featuring the novel 2,4- D choline salt in a premix with glyphosate , has been developed and is planned for sale (pending applicable registrations) under the trade name “ Enlist D uo”. Combining the features of the 2,4- D choline salt with new developments in proprietary formulation and manufacturing science has resulted in a 2,4-D herbicide product with significantly reduced potential for drift and volatility
as well as decreased o dor and better handling properties.

To first look at the herbicide rates used on a single acre, a recent study modeled several farms
in the key soybean growing areas [ 7 ]. The study found that when the average Enlist Duo herbicide use rates were compared to the average use rates of the top alternate, currently
available herbicides popular for controlling glyphosate-resistant weeds, the use of Enlist Duo
on DAS -68416-4 soybean would have a similar per acre environmental load of herbicides compared to the currently available programs.

To realistically estimate the total 2,4 -D volume increase across the country that may occur with Enlist soybeans and Enlist Duo, the following scenarios were developed based on realist ic and expected application rates and use patterns, with conservative (bias towards over-predicting) assumptions on adoption rates.

Scenario 1 assumes growers will only apply Enlist Duo to DAS-68416-4 soybean where growers are facing or actively trying to prevent the establishment of glyphosate- resistant weeds. Additionally this also assumes that all farmers with soybean acres that have glyphosate- resistant weeds will plant DAS -68416-4 soybean and will use Enlist Duo herbicide. The projections indicate an approximate six fold increase in 2,4 -D use in 2020 compared to the volume of 2,4-D currently used on soybeans.

Scenario 2 assumes that all acres of DAS -68416-4 soybean would receive applications of Enlist Duo, regardless of weed control need, and thus relies on estimates of the projected market share of the DAS -68416-4 soybean. These projections estimate an approximately nin e fold increase in 2,4 -D use compared to what is currently used on conventional soybean.Page 28 Scenario 3 assumes that all current glyphosate

- tolerant soybean acres except those with a directly competing technology would be planted with varieties that also contain the DAS

68416- 4 trait. This estimation of adoption rate exceeds likely projections but provides an upper confidence level on 2,4-D volume. While DAS -68416- 4 soybean will be stacked
with a glyphosate- tolerant trait

, it is impractical to assume that all glyphosate- tolerant soybeans will be stacked with the DAS -68416-4 trait due to competing offerings by other seed companies and the likelihood of other herbicide-tolerant soybean options. Even
with this extreme assum ption, the estimated 2,4-D volume is only a fourteen fold increase in 2,4-D use on soybean compared to the current use of 2,4-D on soybean.

When actual use patterns and market dynamics are taken into consideration, more reasonable projections are only a six to nine fold increase, with an extremely conservative estimate of only
fourteen fold.

Introduction of New Technology

A new herbicide product, to be commercialized as Enlist Duo, is currently under regulatory review at the Environmental Protection Agency (EPA or the Agency) 1 . This product, whenapproved, will be marketed for use on DAS-68416-4 soybean. Enlist Duo is a proprietary premix of 2,4-D choline and glyphosate DMA and features Colex -D TM Technology. Prominent attributes of this technology are a greatly reduced volatility and drift profile, very low odor and better handling characteristics (MRID 48862902 and 48844001). Enlist Duo is formulated as an approximate 1:1 ratio of 2,4-D choline:glyphosate DMA. Use directions for Enlist Duo have
been well described in the draft Environmental Assessment for DAS-68416-4 soybean and documents previously submitted by DAS to EPA and USDA.

The new Use Directions under consideration by EPA will allow a pre-emergent (burn down) application of 0.5-1 lb acid equivalents/acre (ae/ac) of 2,4 -D (and glyphosate) and up to two applications (0.5-1 lb 2,4- D ae/ac each, and glyphosate) post -emergent through the R2(flowering) stage. Total seasonal use is limited to a total of 3 lbs 2,4

- D ae/ac/season, identicalto the current seasonal maximum use of 2,4-D on corn (conventional or Enlist corn). DAS68416-4 soybean will also tolerate applications of the herbicide glufosinate which are typical of existing, commercially

- available glufosinate -tolerant soybeans.

1 EPA published a Notice of Receipt on May 23, 2012, opening up a comment period that ends on June 22, 2012. See 77 Fed. Reg. 30524, 30526 (May 23, 2012) (Active ingredient: 2,4

- D choline salt.) Proposed Classification/Use:

Enlist AAD

– 1 Soybean (Trait Code: DAS

- 68416 -4 ).Page 29 Current 2,4 -D Use on Soybean

The current EPA -approved use directions for 2,4-D on conventional soybean allows a single

pre -plant (burn down) application of 0.35- 1 lb acid equivalents/acre (ae/ac) of 2,4 -D. There is a 7 to 30 day pre-plant restriction, depending on the application rate used during the pre-plant application.

Estimates of US soybean acreage from private and public sources ranges from 74MM acres to approximately 79 MM acres. Current soybean acreage is estimated by USDA at approximately
76 million acr es ( http://usda.mannlib.cornell.edu/MannUsda/viewDocumentInfo.do?documentID=1000 ). 2,4- D for burn down is currently used on approximately < 10 % of the soybean acres with a recent historical range from 4%-10% of soybean acreage according to USDA estimates (Plant Pest Risk Assessment; ( http://www.regulations.gov/#!docketDetail;dct=FR+PR+N+O+SR;rpp=10;po=0;D=APHIS2012-0019 )

. When 2,4-D is utilized in a burn down or pre- plant treatment, it is almost always combined in a tank mix with glyphosate or other non- selective herbicide and, when tank

mixed, 2,4- D is generally recommended at the lower end of the rate range ~ 0.5 lbs ae/ac ( http://www3.ag.purdue.edu/btny/weedscience/Documents/BurndownMadness.pdf ). 2,4- D is currently labeled for a single pre-plant application at 0.35 to 1 lbs ae/ac. While current estimates of 2,4 -D volume used on soybean are not readily available in a public format, third party proprietary data is presented in Table 1.

From 2008-2011, 2,4- D use as a pre

- plant burn down material has grown in total acres as well as percentage of acres treated. This is likely a result of the increase in glyphosate

- resistant
weeds as well as hard

- to -control weeds. Starting the planting season with weed fr ee fields has been cited as one of many important integrated resistance management tools ( http://www.hracglobal.com/ ).

Table 1. 2,4- D Use on Soybean

From third party proprietary data

Current Glyphosate Use on Soybean

Current glyphosate use directions approved by EPA for use on glyphosate- tolerant soybean
allow:

Year Total
Acres Acres
treated with 2,4- D Treated
Acres % of
Total
Acres Total Pounds 2,4- D Lbs 2,4

- D/Acre Total Applications/
Acre

2008 74,404,953 5,068,628 7 2,716,207 0.54 1.01
2009 77,584,979 7,637,880 10 3,680,330 0.48 1.01
2010 78,725,007 7,763,593 10 4,106,140 0.53 1.00
2011 74,835,007 8,832,324 12 4,893,146 0.55 1.00Page 30 A maximum pre -emergence application amount of 3.7 lbs glyphosate ae/ac, and postemergent applications from 0.75 to 1.5 lbs glyphosate ae/ac (total 2.25 lbs ae/ac /season ). An additional pre-harvest application of 0.77 lbs ae/ac can be made. Total seasona l use rate is 6 lbs glyphosate ae/ac.

Third party proprietary market research data indicate that the percentage of total soybean acreage that is planted to glyphosate- tolerant soybean s has been steady at 94% -96% over the last four years (Table 2). Total pounds of glyphosate applied to soybean has increased during this time (along with 2,4-D use, as mentioned above). There is a slight but increasing trend in the rate of glyphosate applied per acre but the total number of applications made per ac re has remained steady. These application rate increases reflect the fact that farmers are experiencing the need to increase rates to control increasing levels of hard

- to -control and glyphosate- resistant weeds. Additionally, the use of non-glyphosate herbicides added into the glyphosate- tolerant system has grown steadily since 2006 1 indicating farmers are adding more inputs into controlling glyphosate- resistant and hard

- to -control weeds.

Table 2. Glyphosate Use on Glyphosate Tolerant Soybean

From third party proprietary data

Changes in 2,4- D and Glyphosate Use Directions for Enlist Duo Herbicide

Enlist Duo TM Herbicide was designed to fit with the existing EPA -approved glyphosate use pattern which has resulted in many benefits including reduced erosion and runoff. Glyphosate is expected to remain a core post

- emergent herbicide due to these benefits, as well a s its broad spectrum of weed control. Use Directions for Enlist Duo were developed to directly overlap with the glyphosate use pattern on soybean, so that farmers who currently use glyphosate will find it extremely easy to use Enlist Duo on DAS-68416-4 so ybean.

As described above, Enlist Duo herbicide is an approximate 1:1 premix of 2,4-D choline and glyphosate DMA, based on acid equivalents. By using Enlist Duo herbicide on DAS-68416-4 soybean, the amount of glyphosate use could be:

 A single 1.0 lb glyphosate ae/ac application made pre

- emergence;  Up to two post

- emergent applications each at 1.0 lbs glyphosate ae/ac.

While DAS -68416-4 soybean growers could make additional glyphosate applications, up to the seasonal maximum allowed on glyphosate labels, Dow AgroSciences (DAS) expects that additional glyphosate applications would be unlikely due to Enlist Duo’s improved weed control,

Year To tal
Acres Gly

- Tol
Acres Gly

- Tol as
% of Total
Acres Total Pounds Gly Lbs Gly/Acre Total Applications/
Acre
2008 74,404,953 71,592,624 96 95,398,687 1.32 1.58
2009 77,584,979 73,219,835 94 96,415,627 1.30 1.55
2010 78,725,007 74,059,182 94 102,162,527 1.38 1.58
2011 74,835,007 71,734,538 96 100,121,452 1.40 1.54Page 31 current glyphosate use on soybean, the growing use of foundational herbicide (preplant) programs, the adoption of other products with additional modes of action, and other cultural
mechanisms for weed control.

The EPA

- approved label directio ns for use of 2,4-D on soybean currently allows a single preplant application of up to 1.0 lbs ae/ac. No post emergent applications are currently approved as conventional soybeans are not tolerant to 2,4- D.

With the Enlist Weed Control System and use of Enlist Duo herbicide, possible 2,4- D
choline use on DAS-68416- 4 soybean could be:

 A single ~1.0 lb 2,4- D ae/ac application made pre

- emergence;  Up to two post

- emergent applications each up to ~1.0 lbs 2.4- D ae/ac.

Thus, use of Enlist Duo herbicide would provide for a total possible seasonal use of up to 3 lbs ae/ac of 2,4 -D choline (or 6 lbs ae/ac of both 2,4-D and glyphosate actives) on DAS-68416-4 soybean (Figure 1).

Glufosinate Use on Soybean

Glufosinate is a nonselective glutamine synt hetase inhibiting herbicide that is used to control

grass es, sedges and broadleaf weeds. Since it is a nonselective herbicide it would injure or kill crop plants that it contacts. Several crop plants have been modified by inserting a gene that produces and enzyme which detoxifies glufosinate by converting the herbicide into a non- active form. To date glufosinate tolerant soybeans, corn, canola and cotton have been commercialized.Page 32 Due to its nonselective activity, glufosinate has a weed management spectru m similar to glyphosate and its use has grown, particularly in areas with glyphosate- resistant weeds ( http://southeastfarmpress.com/cotton/glufosinate -herbicide- shortage

- sparks -controversy ). Soybean is a member of the broadleaf family and as such is extremely sensitive to glufosinate with minute quantities causing severe injury or death to conventional soybean plants. DAS

68416-4 soybean is tolerant to glufosinate at current commercial application rates used for glufosinate- tolerant broadleaf crops.

Glufosinate tolerance in Enlist soybean enables use of glufosinate as a herbicide on commercially grown soybeans but also provides use as a selection agent in breeding programs and seed amplification.

Bayer Crop Science has registered glufosinate for use on glufosinate tolerant crops including soybean. Ignite 280 SL Herbicide (EPA Reg. No. 264-829) is a commercially available glufosinate containing herbicide with directions for use on glufosinate tolerant crops, including soybean.

T olerance to glufosinate offers a n alternative mode of action to glyphosate for the broadspectrum control of weeds in soybean. Glyphosate is a strong nonselective h erbicide that controls both grasses and broadleaved weeds, but reports in the science literature indicate that
thirteen weed species have developed resistance to glyphosate in the US ( http://www.weedscience.org/In.asp ). To date, only Italian Ryegrass has been reported as resistant to glufosinate in the US and is located in Oregon. However, this population of Italian Ryegrass also appears tolerant to glyphosate.

Glu fosinate tolerant soybeans are a more recent introduction than glyphosate-tolerant soybeans. The number of acres planted to glufosinate tolerant soybeans has grown steadily but is still a very small fraction of total soybean acres. Average seasonal use rate is about a half pound per acre with just over 1 application per acre made. Glufosinate can also be used as a pre -plant (burn down) treatment on conventional and glufosinate tolerant soybean, however volume estimates for this use have a high degree of uncertainty. For the years 2009-2011only a total of 46,000 lbs were used in a preplant treatment and 75% of those pounds were used in 2011.

Glufosinate is a non- selective herbicide similar to glyphosate with a wide spectrum ofsusceptible grass and broadleaved weeds. With over 90% of the soy acres planted to glyphosatetolerant varieties it would appear that glufosinate offers a viable alternative particularly to farmers facing glyphosate -resistant weed problems. However, based on the low adoption ra tes of glufosinate tolerant soybeans, it appears that farmers may favor the glyphosate system. Other than a longer time of experience with the glyphosate- tolerant system, a review of the respective labels indicates that glufosinate may need to be applied to smaller weeds with finer droplet sizes and larger carrier volumes to achieve adequate control. Glyphosate translocates readily throughout the plant whereas glufosinate has limited mobility in the plant, thus requiring better coverage for control (henc e the larger carrier volumes and smaller droplet sizes).Page 33 Table 3. Postemergent Glufosinate Use on Glufosinate Tolerant Soybeans

Year Total Acres Glu

- Tol
Acres Glu

- Tol as
% of Total
Acres Total Lbs of
Glufosinate Lbs
Glu/Acre Total Applications/
Acre
2008 74,404,953

2009 77,584,979 208,577 0.3 68,751 0.46 1.17
2010 78,725,007 892,476 1.1 452,163 0.52 1.25
2011 74,835,007 997,423 1.3 521,200 0.53 1.18

From third party proprietary data

Changes in Glufosinate Use with Enlist Weed Control System

No changes in glufosinate use directions would be needed. Whether used as a selection agent or as a herbicide, the use directions (application rates and timings) would remain the same

, however, there may be some regulatory actions necessary to enable the use of glufosinate on Enlist soybeans

2,4- D Choline and Glyphosate proposed Use on DAS -68416-4 Soybean

Third

- party proprietary market research demonstrates that approximately 98 % of glyphosatetolerant soybean acres receive at least one glyphosate application (burn down and/or post emergent) . A small population of farmers (~4 %) that purchase glyphosate- tolerant soybean s elect not to make a post

- emergent glyphosate application. The market research also indicates that only 22% of planted soybean acres currently receive a burn -down (pre-plant or preemergence) herbicide application.

Utilizing the historically consistent data from the current and broad use of glyphosate on soybean (Table 2) plus field trial data on weed control with various herbicide application rates, DAS has estimated that farmers who grow DAS -68416-4 soybean will use an average of 0.875 lbs 2,4- D ae/ac/application with an average of 1. 54 applications per season (includes burn down and post emergent) . Th e application rate (0.875 lbs 2,4- D ae/ac) is the midpoint between the medium and high rates allowed on the Enlist Duo label and is consistent with the glyphosate rate needed for weed control. As Enlist Duo contains an ~1:1 ratio of 2,4-D and glyphosate ne arly identical rates of glyphosate will be applied.

Estimating total acres of DAS -68416-4 soybean planted and the use of Enlist Duo herbicide on that soybean has many inherent accuracy limitations, and it is difficult, if not impossible, to make any such predictions with certainty. Nevertheless, DAS has derived three scenarios to estimate the potential use of 2,4

- D in DAS -68416-4 soybean after deregulation and
commercialization:

2,4- D: Scenario One. The first scenario assumes that growers will only apply Enlist Duo to
DAS -68416- 4 soybean where growers are facing or actively trying to prevent the establishmentPage 34 of glyphosate- resistant weeds. Additionally this also assumes that all farmers with soybean
acres that have glyphosate- resistant weeds will plant DA S-68416- 4 soybean and will use Enlist Duo herbicide (a very aggressive assumption due to other weed control options available). Using third party market data, DAS has estimated that 5% of US soybean acreage had glyphosate- resistant weeds in 2010, and that the percentage would grow to 10% of soybean acreage by 2015 and to 30% by 2020 (Figure 2). This is consistent with, but less aggressive
than , predictions made by other ot hers, (see Foresman, Figure 2, also http://phys.org/news203697204.html ).

Figure 2. Projected corn and soybean acres infested with glyphosate resistant weeds.

Sources:

Foresman, C. 2009. Syngenta Resistance Fighter TM Messag e Board. http://blog.syngenta

us.com/blogs/ask_the_expert/archive/2009/04.aspx Accessed January 16, 2011. Dow AgroSciences LLC.Page 35 Assuming that minimal additional acreage would be treated to prevent glyphosate- resistant weeds from becoming established, and using the assumptions set forth above regarding total soybean acres, application rates and applications per season, the following formula was used to calculate total lbs of 2,4

- D ae that might be used on DAS -68416-4 soybean:

76MM acres x 30% resistant weeds (in 2020) x .875 lbs ae/ac/application x 1.54 applications/season = 31MM lbs 2,4- D ae per year. This represents an approximate 6 fold increase in 2,4-D use in 2020 compared to the volume of 2,4-D currently used on
conventional soybean.

2,4- D: Scenario Two. The second scenario assumes, for purposes of this discussion, that all
acres of DAS -68416-4 soybean would receive applications of Enlist Duo, regardless of weed control need, and thus relies on estimates of what the projected market share of DAS-68416-4 soybean will be:

DAS sells soybean seed through its subsidiary seed companies, i.e., Mycogen Seeds, Renze Seeds, Dairyland Seed, Pfister Seeds, Brodbeck Seeds, Triumph Seed, Prairie Brand Seed and Hyland Seeds. Through these subsidiaries, DAS currently ha s < 3 % of the market share for soybean, markets for which DAS-68416-4 soybean could be introgressed. At this time, DAS is not planning to breed DAS-68416-4 soybean into all of its soybean varieties , so DAS -68416-4 soybean would occupy less than DAS’s current < 3% of the market. However, for purposes of this estimate, 3 % will be used as a minimum potential DAS -68416- 4 soybean acreage.

DAS is interested in and is pursuing licensing agreements with additional soybean seed companies to breed DAS-68416-4 soy bean into a licensee’s soybean germplasm. To date, two licensing agreement have been made representing ~35% of the market . Through natural growth
and these licensing arrangements it is reasonably possible that, at maturity, approximately 45% of the soybean germplasm could have the Enlist trait. Together with DAS’s market share, for purposes of this estimate, we therefore assume DAS -68416-4 soybean could ultimately be bred into soybean varieties planted on up to 45% of the total soybean acreage.

Due to the technical aspects of soybean seed breeding, rapid improvement of germplasm and stacking with other traits, this level of adoption of DAS-68416- 4 soybean is estimated to take 5

- 10 years to reach maturity (maturity in 2018 -2023), which is consistent with other current herbicide tolerant traits. Application rates of 2,4-D are as described above: an average of 0.875 lbs ae/ac/application with 1. 54 applications per year.Page 36 Utilizing the data and assumptions stated in this scenario, the estimated range of ac reage and 2,4-
D volume can be estimated as follows:

76 MM acres x 45% market share x 100% DAS -68416-4 soybean acres treated x 0.875 lbs ae/ac/application x 1. 54 estimated applications per DAS -68416- 4 soybean acre = 46,084,500 lbs 2,4- D ae per year. This represents approximately an 9X increase in 2,4- D use compared to what is currently used on conventional soybean.

2,4- D: Scenario Three : The third scenario assumes that all current glyphosate- tolerant soybean acres would be planted to hybrids that also cont ain the DAS -68416-4 soybean trait. This is a high estimation of adoption rate but provides an upper confidence level on 2,4-D volume. DAS68416- 4 soybean will be stacked with a glyphosate- tolerant trait but it is impractical to assume
that all glyphosate- tolerant traits will be stacked with DAS -68416-4 soybean due to competing offerings by other seed companies and the likelihood of other herbicide-tolerant soybean options. Due to one developing technology that will be a direct competitor to the Enlist Weed Control System, at least 32% of the market will not contain the DAS -68416- 4 soybean trait. Therefore

, 24,320,000 acres can be subtracted from the 76MM acre total soybean acreage. Thus, 52 MM
acres of the 76 MM total soybean acres are considered planted to a variety containing the DAS

68416-4 soybean trait . Using the same application information and other assumptions used in the previous two scenarios, the 2,4- D volume can be estimated as follows:

52 MM glyphosate- tolerant acres x 100 % DAS -68416-4 soybean acres treated x 0.875 lbs ae/ac/application x 1. 54 estimated applications per DAS -68416- 4 soybean acre = 70,070,000 lbs 2,4- D per year. This represents a 14 -fold increase in 2,4-D use on soybean compared to the current use of 2,4-D on conventional soybean.

Glufosinate Proposed Use on DAS -68416-4 Soybean

Given the recent introduction of glufosinate tolerant soybeans and the very small market share they have achieved in the last four years it is understandably difficult to predict glufosinate volume s for DAS -68416- 4 soybean. This is accentuated by the commercial offering of Enlist Duo herbicide which contains glyphosate. Glyphosate and glufosinate would compete for the same spot in a herbicide program and with 2,4-D adding the control of glyphosate- resistant weeds there is little room left to rationalize use of glufosinate. However that does not preclude its use and it does offer a valuable alternative mode of action. Therefore a scenario was developed that 10% of the acreage containing DAS -68416-4 soybean would receive glufosinate treatments consistent with how glufosinate is currently being used on glufosinate tolerant soybean.

Glufosinate Use in Soybean: This scenario assumes that glufosinate will be used on 10% of the acres containing DAS -68416- 4 soybean trait and receive glufosinate treatments equal to what is used today on glufosinate tolerant soybean.Page 37 76MM acres x 45% market share x 10% of acres treated x 0.53 lbs ai/ac (from Table3) = 1,812,600 lbs glufosinate. This is ~3.5 fold increase compared to what is currently used on all glufosinate tolerant soybeans.

Environmental Loading of Herbicides Used on Soybean DAS has conducted an analysis to determine the anticipated impact on environmental loading of
herb icides resulting from the use of 2,4- D choline on DAS -68416-4 soybean. Specifically, this analysis looked at the environmental load of herbicides applied on glyphosate- tolerant soybean and soybeans to control glyphosate- resistant and hard

- to

- control weed biotypes [ 7 ]. The top currently available herbicide programs (excluding just increasing the rate of glyphosate alone) that are currently being recommended to control glyphosate- resistant weeds in soybean under scenarios representative of different key soybean -growing regions were compared to projected use of Enlist soybeans and Enlist Duo herbicide . While the range of rates of these currently available alternate programs and the ones for Enlist programs overlapped, when the average of the Enlist program rates were compared to the average of all of these top alternates, the analysis indicated that the use of 2,4-D on herbicide tolerant DAS-68416-4 soybean would marginally increase the per acre environmental load of herbicides compared to the top, currently available,

non- glyphosate alternative programs. Several of the currently available alternatives for use on soybeans are used at extremely low rates, thus the apparent increase in volume for 2,4- D when compared to these alternatives. It should be recognized that weed resistance is increasing for many of these alternative chemistries so their use rates may be expected to increase or their use may be discontinued depending upon the severity of resistance developmen t.

In DAS -68416-4 soybeans, the analysis indicated that the use of 2,4-D on herbicide tolerant
DAS -68416-4 soybeans will vary from a reduction in one scenario of 0.10 lbs ae /ac to an increase in others of up to 0.65 lbs ae /ac, with an average increase acro ss all scenarios of only 0.3 lbs, compared to the use of currently registered alternative non-glyphosate herbicides. The results in soybeans differ from a similar exercise for corn (previously submitted) because many
of the non- glyphosate herbicide altern atives for control of broadleaf weeds in soybeans are very low rate products (examples: carfentrazone, cloransulam, clorimuron, flumioxazin, fomesafen, sulfentrazone). Management of glyphosate- resistant and hard

- to -control weeds with current non-glyphos ate herbicide alternatives is, however, complicated by widespread resistance to ALS and triazine herbicides and developing resistance to PPO inhibitor and HPPD inhibitor
herbicides.

A more recent study has been published that broke the country into six reg ions to assess the impact on total herbicide use with the introduction of DAS -68416-4 soybeans and DAS -40278-9 corn as well as a developing cotton trait ( See appendix 5 this submission ). The report depicts a rapidly growing increase in herbicide use to combat resistant weeds out to 2020. Several scenarios for corn, soy and cotton were developed with varying levels of adoption for Enlist corn (DAS -40278- 9), soy (DAS -68416-4) and cotton (not yet submitted). Under low adoption
scenarios for DAS -40278-9 and DAS -68416-4 total herbicide use is projected to be reduced by 4% (17 million pounds) compared to the volume used with the adoption of these two new traits. Under high adoption scenarios, the reduction in total herbicide volume is very substantial. Adoption of these traits with the accompanying 2,4- D use will result in as much as 92 million pounds less total herbicide use. The reduction in total herbicide use is based on displacement ofPage 38 those herbicides that will be used in an expanding manner with the introduction of these new
traits.

Ecological Assessment of Herbicide Use on Soybean

The EPA is the regulatory agency responsible for the review and approval or denial of all pesticide registrations. It is a violation of federal law for pesticides to be sold or distributed without an EPA registration. The Agency uses a risk assessment pro cess in its registration decisions, evaluating risk based on exposure and hazard, for both humans and ecological organisms. EPA cannot register the use of a pesticide, or amend an existing registration to add a new use, unless the use of the pesticide mee ts the statutory “no unreasonable adverse effects” standard, i.e., EPA can only register new pesticides or pesticide uses if the use of that pesticide in
accordance with the EPA -approved label will cause no unreasonable adverse effects on human
health or the environment.

In order to make its registration decisions, the Agency develops exposure assessments that characterize the potential environmental exposures that may result from the use of a pesticide. EPA uses the results of environmental fate studies, in combination with modeling work and pesticide use information to characterize the environmental fate of the pesticide in question.

The Agency also uses modeling work to conservatively predict potential impacts on surface and ground water. This mode ling work is used not only for environmental risk evaluations but is also an input parameter into dietary risk evaluations for humans (providing the drinking water component for dietary assessments).

The results of the environmental fate work enable EPA t o determine where a pesticide and its metabolites and degradates will go in the environment (air, water, soil), how long they will persist, and in what quantities. Based on study, model, and use information, the Agency then develops estimated environmental concentrations (EECs), which are compared to the toxicity endpoints of ecotoxicology studies for risk assessment purposes. EEC values are based on the maximum allowable application rate(s) for a pesticide even though typical application
rates are lower t han the maximum.

As in the case of risk assessments for humans, EPA scientists use the most sensitive toxicity endpoints for ecotoxicology studies for risk assessment purposes. Using EECs based on maximum application rates and the most sensitive toxicity endpoints ensures that EPA risk assessments for wildlife are conservative and protective.

EPA uses risk quotients (RQ’s) and levels of concern (LOC) for acute and chronic risk to wildlife to quantify and characterize risk assessments for plants and anima ls. RQ’s are ratios of EEC values over toxicity endpoints. The Agency uses different LOCs for non- endangered and endangered species. If planned use rates and use techniques result in RQ values that exceed LOCs, EPA may conduct a more refined risk assessment to better characterize risk. The Agency also considers how to mitigate potential risks, which may require changes in application rates and techniques, or may otherwise limit the use of the pesticide.

EPA assessments of potential impacts on wildlife an d the environment are designed to bePage 39 conservative and protective. The Agency wants to be cautious in its assessments and would rather overstate than understate risk concerns. Each intended use pattern (e.g., soybean, soybeans, consumer use) is evaluated. Agency environmental and ecological assessments are designed to cover each particular use of a pesticide (e.g., soybean) regardless of whether all soybean acreage is treated or only a portion of the acreage is treated (much more typical). Thus, even if the percent crop treated increases, the EPA assessments are still valid.

2,4-D has an extensive history of safe and effective use. It has been thoroughly reviewed and reregistered by all major regulatory agencies in the world within the last ten years. Recently (April 2012), the EPA denied a petition to cancel the tolerances and registrations for 2,4- D based on toxicological hazard. The Agency issued a resounding denial of that petition, affirming that 2,4-D posed no unreasonable risk when used as direc ted [ 8 ].

Summary

The introduction of the Enlist Weed Control System and Enlist Duo herbicide will provide a much needed additional weed control tool to soybean farmers in American agriculture. The Enlist Weed Control System offers a novel mechanism of herbicide tolerance in combination with multipl e modes of action

– factors which ha ve been cited by the National Academy of Sciences and the Weed Science Society of America as key components to an effective resistant weed management plan. The introduction of herbicide tolerant crops has helped enable t he growing practice of no

- till agriculture which has resulted in dramatic reductions in soil loss through erosion, made farming much more efficient, reduced trips across the field with resultant fuel and equipment savings, and enabled farmers to proficient ly farm more acres [ 7 ]. Projected increased volumes of 2,4-D ranged from six to 14-fold with the adoption of Enlist soybeans. The volume increase is largely driven by the Enlist system enabling post- emergent use in soybean which is not currently available.

This exercise depicts the current use of 2,4 -D in conventional soybean and the expanded use of 2,4-D choline introduced in Enlist Duo herbicide with the adoption of Enlist soybean and the Enlist Weed Control System. Additionally, estimates on the use of glyphosate and glufosinate in
DAS -68416-4 soybean are portrayed. While growers will get improved weed control performance they will also benefit from the additional attributes of Enlist Duo herbicide, particular ly the reduction in off- target movement potential via drift or volatility. These improvements help keep the herbicide on the treated field, further reducing risk to the environment and ecological organisms.Page 40 S ECTION 3: 2,4- D OFF

- TARGET EXPOSURE AND SENSITIVE CROPS

Relevant to DAS -68416-4 Draft EA Section 2.1.2, 2.2.3, 2.3.2, 4.2.2, 5

Federal and state regulation of off- target pesticide movement

EPA is the federal agency vested with the authority and responsibility for regulating the sale, distribution and use of pesticides, including herbicides such as 2,4-D. EPA registers or approves a pesticide for one or more uses only after determining that the product will not cause
unreasonable adverse effects on the environment – the statutory test for registration under FIFRA. When EPA approves the registration of a pesticide, it approves a particular product for a particular use or uses under specified conditions (including composition, application methods, usage rates, and protective measures) and specifies the language that must appear on the label of the pesticide product that sets forth those conditions and limitations. If a pesticide product is

use d in a manner that is inconsistent with its labeling, the user is subject to federal and state enforcement action. When making its registration decision, EPA specifies the data and information it needs to support that registration. Among the data EPA req uires are those relating to off-target pesticide movement including, e.g., spray drift and volatilization (40 C.F.R. Part 158, Subparts L and N).

Federal law requires EPA to periodically review existing pesticide registrations to ensure that they meet th e FIFRA standard for registration (the "no unreasonable adverse effects" criteria of FIFRA) under current scientific standards. EPA specifically addressed issues regarding off

- site pesticide movement of 2,4- D in EPA’s 2005 Reregistration Eligibility Decis ion (RED) for 2,4- D, which incorporated major label revisions to products containing 2,4-D. These revisions included:

• lower limits for spray droplet size;

• prohibitions on spraying at wind speeds greater than 15 mph, spraying with a wind
direction that is not favorable to on-target deposition, or spraying with sensitive nontarget crops within 250 feet downwind;

• a prohibition on spraying at wind speeds of less than 3 mph if there are temperature inversion conditions, or stable atmospheric conditions at or below nozzle height;

• a prohibition on spraying where sensitive crops might otherwise be susceptible to drift;

• restrictions on boom length and spray release height for aerial applications, and nozzle height for ground boom applications;

• lower limits on application rates and total applications per year for specific crops; and

• compliance with any state and local laws that are more stringent (e.g., California, areas of which have seasonal limitations on use of 2,4- D) [ 9 ].

EPA determined the use of the then-existing formulations of 2,4-D to be eligible for reregistration with those label restrictions.

As mentioned above, states also regulate the use of pesticides, including herbicides. A number of states have passed laws to specifically address spray drift [ 10 ] . These laws may include penalties and/or restrict application methods, require prior notification, impose buffer zones, etc., as each state has deemed appropriate.Page 41 Additional EPA actions to address spray drift and volatility

In addition to registering individual pesticides, EPA also regularly assesses the safety of pesticide use more broadly, and has repeatedly addressed issues associated with off

- target pesticide movement. Some of these efforts include:

• In 2009, EPA developed and issued for public comment a draft guidance document (PR Notice) on Pesticide Drift Labeling to provide guidance to pesticide manufacturers on labeling statements concerning pesticide drift, and to inform the public of EPA’s policies with regard to pesticide drift. EPA continues to work with stakeholders to finalize this guidance.

• For many years EPA has contributed funding to support education and training programs on drift management. EPA provides annual funds to states to support pesticide applicator training programs, many of which include educational material on drift management, and EPA has contributed to other educational programs, such as the National Coalition on
Drift Minimization educational video and CD- Rom, the National Pesticide Applicator Certification Core Manual, and the National Agricultural Aviation Association’s Professional Aerial Applicator Support System (PAASS) to support their training and education programs to reduce drift incidents.

• EPA encourages pesticide applicators to use all feasible means available to them to
minimize off -target drift. To support this goal, EPA has stated its intent to work with applicators, agricultural extension agents, registrants, environmental groups, and other interested stakeholders to collect and develop information on best management practices (BMPs) to reduce off -target drift for specific application methods and crop sector combinations. These guidance documents will be consolidated by EPA and made
available online.

• OPP and the EPA’s Office of Research and Development are developing a new voluntary program, the Drift Reduction Technology (DRT) Program, which encourages the development, marketing, and use of application technologies, verified to significantly reduce spray drift.

• EPA has also taken action to address issues around pesticide volatility. In December 2009, EPA convened the FIFRA Scientific Advisory Panel (SAP) to e xamine scientific issues associated with field volatilization of conventional pesticides, focusing on methodologies by which bystander inhalation could be measured.

Additional information relating to EPA’s actions to address spray drift may be found at its
website at http://www.epa.gov/pesticides/factsheets/spraydrift.htm

. Existing precautions agai nst off -target exposure

Despite federal and state controls and the best efforts of applicators, off- target pesticide movement occasionally damages neighboring crops. Crops may be exposed to pesticide volatility or drift from a variety of sources, including public right of way uses for road maintenance and utilities, and agricultural uses [ 11 ]. Crops that have the potential for damage due to exposure to a particular pesticide are considered sensiti ve crops. Sensitive crop growers use a number of approaches to protect their crops from off-target exposure. Location of wherePage 42 the crop is grown is a key consideration; sensitive crop growers may choose to plant in fields that are sheltered or protected from potential exposure, and are not immediately adjacent to conventional crops 2 . Buffer zones and vegetative barriers are often used as a no spray zone between a sensitive area and a crop being sprayed. A buffer zone may be a vegetative barrier consisting of groves, hedge rows, wind breaks, pastures, or even the grower’s own conventional crops. Vegetation planted in strategic lines can reduce the extent of spray drift of agricultural chemicals by filtering out spray droplets in air passing through thei r foliage [ 12 ]. In some cases, growers are able to select a sensitive crop variety that is less sensitive to pesticides that are commonly applied to neighboring areas. Modified cultural practices, including timing of operations, are another approach that can be used to protect against off-target exposure[ 13 ].

Sensitive crop growers may avoid exposure in right of way areas by posting signs and making arrangements with government road crews or utility companies to do their own maintenance of easements and road ways near their sen sitive crops. Similarly, neighboring farms can be notified of the presence of sensitive crops that require protection from herbicide spray drift and volatility. Since applications of herbicides are increasingly being made by custom applicators, signage placed near field entrances alerting operators to the presence of sensitive crops and that no sprays are allowed, are also used. Alternatively, sensitive crop growers may notify the local coops and applicators directly. There are also tools available on the internet for growers to register sensitive crop fields so that pesticide applicators can easily locate registered sites before they spray using a Google MapsTM interface[ 14 ].

If crop damage occurs, affected growers can seek compensation by a variety of mechanisms. The pesticide applicator may have insurance to cover such losses. State pesticide enforcement bureaus are notified to view and document the damage. In some states, the applicator may be subject to fines or other penalties[ 10 ] . The crop damage may also give rise to claims for legal damages in private la wsuits.

Potential off -target pesticide impacts on organic crops

Growers of organic crops may also face economic damages from off

- target pesticide movement, even if their crops are not damaged. If a certifying agent tests a crop grown under organic production and the test reveals the presence of residues from a pesticide not approved for use under the National Organic Program (NOP), the crop may not be sold as organic if the residue is present at a level greater than five percent of the EPA tolerance for the detected prohibited residue (7 CFR 205.671). A grower whose organic crops were subject to off- target pesticide movement that resulted in residue levels greater than five percent of the EPA tolerance could then lose the organic premium he may otherwise have obtained for his crop. While some certifying agents have refused to allow organic production on fields that have been the objects of spray drift, a recent court decision found this three year ban on organic production following spray drift to be inconsistent with the NOP ( Johnson v. Paynesville Farmers Union Cooperative Oil Co., 2012 WL 3101667 (Minn.) at 16).

2 U of IL Extension. Reducing Pesticide Drift. University of Illinois Extension and Illinois Department of AgriculturePage 43 In finalizing the NOP, USDA described the following in regards to grower’s responsibilities to protect against chemical drift (65 FR 80556):

Drift has been a difficult issue for organic producers from the beginning. Organic operations have always had to worry about the potential for drift from neighboring operations, particularly drift of synthetic chemical pesticides. As the number of organic farms increases, so does the potential for conflict between organic and nonorganic operations.

It has always been the responsibility of organic operations to manage potential contact of organic products with other substances not approved for use in organic production systems, whether from the nonorganic portion of a split operation or from neighboring farms. The organic system plan must outline steps that an organic operation will take to avoid this kind of
unintentional contact.

When we are considering drift issues, it is particularly important to remember that organic standards are process based. Certifying agents attest to the ability of organic operations to follow a set of production standards and practices that meet the requirements of the Act and the regulations.

All of the preventions discussed above are available to organic growers and many are required by the NOP as part of their organic production plan. Similarly, insurance and legal recourse may be available to organic growers who lose premiu ms as a result of spray drift.

2,4-D and off- target movement

One of the herbicides that DAS 68416- 4 soybean has been engineered to tolerate is commonly known as 2,4-D. 2,4-D is a synthetic plant growth regulator (auxin) that has been registered for
use in the US as a broadleaf weed herbicide since 1948.[ 15 ] 2,4- D is abso rbed through the leaves and is translocated to the meristems of the plant. Uncontrolled, unsustainable growth ensues, causing stem curl -over, leaf withering, and eventual plant death. Thus, any inadvertent contact to an adjacent broadleaf crop plant, throu gh drift or volatility, has the potential to produce very noticeable physiological symptomology.

As of 2005, EPA had registered over 600 end-use products containing 2,4- D. [ 15 ] Throughout the period 2001-2007, 2,4- D remained the #1 -ranked herbicide for industrial, commercial, governmental, home and garden use, with a tota l annual usage for these applications in the range 24-33 million pounds.[ 16 ] Although from 2001 to 2007 its ranking as a herbicide for agricultural use fell from #4 to #5, annual usage was in a similar range: 28-33 million pounds in 2001 and 25-29 million pounds in 2007.

Since it was introduced in 1948, there have been reports of 2,4- D adversely affecting non

- target broadleaf food and feed crops, such as cotton, grapes and tomatoes, growing in the vicinity of target crops. [ 17 ] Such incidents have been linked to drift of spray droplets (especially through aerial spraying) or drif t of vapors formed by volatilization of the 2,4- D itself. [ 18 ] Drift is the physical movement of spray droplets moving off- site as a chemical application is made. Under certain conditions, the potential for physical drift from an application site to adjacent non- targetenvironments is possible for all types of pesticide spray applications. This is an applicationrelated phenomenon independent of the chemical pesticide, which may be influenced by the formulation ingredients and spray mix additives. Volatilization refers to the transformation of aPage 44 liquid or solid pesticide into a gas. The extent of volatilization is dependent on properties of the chemical and herbicide formulation, and environmental factors such as air temperature, wind speed, and relative humidity. Volatilized pesticides can be carried by air currents potentially leading to off-target exposure.

Increased control of drift and volatilization across pesticides has been achieved with proper equipment setup and attention paid to climatic conditions at the time of application. Univer sity extension agencies have been especially prominent in developing and disseminating “Good Application Practices” to minimize drift. Additionally, pesticide label restrictions, state pesticide regulations, nozzle technology and manufacturer stewardship programs have helped to develop and establish application practices that minimize the potential for off -target exposure.

2,4- D is currently formulated as an ester or amine salt. Attributions of volatility to 2,4

- D have largely been associated with the est ers, particularly short chain esters. Early forms of 2,4- D included short chain esters that were favored due to rapid herbicidal activity, but these were relatively volatile [ 19 ]. A desire to reduce risk of off -target injury to sensitive crops, such as cotton, tomatoes or grapes, led to the development of longer chain esters that were notably lessvolatile, and to development of various amine salts that EPA considers to be essentially nonvolatile. The volatility of the salt forms approaches two orders of magnitude reduction compared to the short chain esters[ 20 ] . In the last two decades, longer chain esters have replaced the shorter chain esters and as a result, volatility issues have largely abated.

New technologies for controlling drift and volatility

DAS conducted an extensive evaluation of various salts under conditions inducing high volatility to identify candidates that had significantly reduced volatility and thus lowered pot ential for injury to susceptible plants. The results led to the development of 2,4-D choline salt. This novel form of 2,4-D has been tested in the laboratory and subsequently in field studies. Quantification of volatilized 2,4-D from soybean and bare soil fields demonstrated : 2,4- D ethylhexylester was the most volatile, with calculated loss rates of the 2,4

- D ethylhexylester as much as two orders of magnitude greater than the 2,4- D dimethylamine (DMA) form, which is considered to be essentially non

- volatile [ 21 ] . As detailed in materials submitted to APHIS by DAS [ 20 ], the choline form of 2,4- D measured as much as 50X less vo latility than the DMA form and had dramatically less injury to a variety of crops known to be sensitive to auxin herbicides under confined conditions as compared to ester and amine forms of 2,4- D.

DAS’s new product containing 2,4-D choline and glyphosate DMA (Enlist Duo herbicide) will make the herbicide spray droplets larger and more uniform in size compared to a standard 2,4- D and glyphosate tank mix application. DAS has measured a 3X improvement (reduction) in driftable fines (<150 μ) for both 2,4 -D choline and glyphosate under field conditions using commercial application equipment. This validates observations made under controlled laboratory and wind tunnel conditions. Coupled with using the latest in drift reduction nozzles, as much as a 10X reduction in drift was achieved compared to a standard tank mix application of the same active ingredients using conventional nozzles.

Pending registration by EPA, DAS intends to market Enlist Duo Herbicide with Colex

- D Technology, a pre-mix of the new 2,4-D choline salt and glyphosate dimethylamine with reduced drift and volatility characteristics, for use with DAS -68416-4 soybeans. Via a Technology UsePage 45 Agreement, DAS will require growers of DAS-68416-4 soybean who choose to use 2,4- D in post-plant applications to purchase the 2,4-D formulation in Enlist Duo to provide this added protection against off-target exposure. A combination of EPA-required label restrictions, contractual obligations and grower ed ucation and outreach will minimize any off

- target effects to neighboring crops caused by application of Enlist Duo to DAS-68416-4 soybeans.

Proposed herbicide label language for Enlist Duo

DAS has submitted to EPA for approval a proposed label for its Enl ist Duo Herbicide with
Colex -D Technology, a pre-mix of the new 2,4-D choline salt and glyphosate DMA. The first submission to EPA is for use on Enlist corn, DAS-40278-9, and once approved then DAS will
submit a label amendment for the use of Enlist Duo o n DAS -68416-4 soybean. DAS’s proposed label contains the instructions for use directly addressing the potential for spray drift and volatility. The same label instructions will be submitted for use on Enlist soybean, DAS -68416- 4. Of course, during its label approval process, EPA may impose additional use restrictions or other protective measures for corn and/or soybean.

DAS has submitted for EPA approval the following Enlist Duo label language specifically addressing spray drift management:

Spray Drift Management

Avoid drift. Use extreme care when applying this product to prevent injury to desirable plants and crops.

Do not allow GF-2726 to mist, drip, drift or splash onto desirable vegetation since minute quantities of this product can cause severe damage or destruction to the crop, plants or other areas on which treatment was not intended. The likelihood of injury occurring from the use of this product increases when winds are gusty, as wind velocity increases, when wind direction is constantly changing or when there are other meteorological conditions that favor spray drift. When spraying, avoid combinations of pressure and nozzle type that will result in fine particles (mist) which are likely to drift. Do not apply at excessive speed or pressure . Use of this product in any manner not consistent with this label may result in injury to persons, animals or crops, or other unintended consequences.

Avoiding spray drift at the application site is the responsibility of the applicator. The
intera ction of many equipment- and

- weather

- related factors determines the potential for spray drift. The applicator and the grower are responsible for considering all these factors when making decisions.

Do not aerially apply this product.

Droplet Size

Apply as a coarse or very coarse spray (ASABE S -572 Standard). Use drift reducing nozzle tips in accordance with manufacturer directions that produce a droplet classification of coarse or very coarse to significantly reduce the potential for drift.

Groundboom A pplicationPage 46 Use the minimum boom height based upon the nozzle manufacturer’s directions. Spray drift potential increases as boom height increases. Spray drift can be minimized if nozzle height is not greater than the maximum height specified by the nozzle manufacturer for
the nozzle selected.

Wind

Drift potential is lowest at wind speeds of 10 mph or less. However, many factors, including droplet size and equipment type, determine drift potential at any given speed. Do not apply at wind speeds greater than 15 mph. Note : Local terrain can influence wind patterns. The applicator should be familiar with local wind patterns and how they affect
drift.

Temperature and Humidity

When making applications in low relative humidity, set up equipment to produce large r droplets to compensate for evaporation. Droplet evaporation is most severe when conditions are both hot and dry.

Temperature Inversions

If applying at wind speeds less than 3 mph, the applicator must determine if: a) conditions of temperature inversion exist, or b) stable atmospheric conditions exist at or below nozzle height. Do not make applications during a temperature inversion or stable atmospheric conditions. Temperature inversions restrict vertical air mixing, which causes small suspended droplets to remain in a concentrated cloud. This cloud can move in unpredictable directions due to the light variable winds common during inversions. Temperature inversions are characterized by increasing temperatures with altitude and are common on nights with limited cloud cover and light to no wind. They begin to form as the sun sets and often continue into the morning. Their presence can be indicated by ground fog; however, if fog is not present, the presence of an inversion can also be identified by the move ment of smoke from a ground source. Smoke that layers and moves laterally in a connected cloud (under low wind conditions) indicates an inversion, while smoke that moves upwards and rapidly dissipates indicates good vertical air mixing.

Drift Setbacks from Sensitive Areas

Allow setbacks (buffer zones) upwind of sensitive area (e.g., residential areas, bodies of water, known habitat for threatened or endangered species, sensitive non -target crops other than those listed above) according to the following table.

If a coarse or very coarse droplet classification cannot be maintained, an upwind setback
of 250 feet from sensitive areas must be observed.

Susceptible Plants

Do not apply under circumstances where spray drift may occur to food, forage, or other plantings that might be damaged or crops thereof rendered unfit for sale, usePage 47 or consumption. Avoid contact of herbicide with foliage, green stems, exposed non-woody roots of crops, desirable plants and trees because severe injury or destruction may result. Small amounts of spray drift that may not be visible may injure susceptible broadleaf plants. Before making an application, please refer to your state’s sensitive crop registry (if available) to identify any commercial specialty or certified organic crops that may be located nearby.

Commercially grown tomatoes and other fruiting vegetables (EPA crop group 8), cucurbits (EPA crop group 9), and grapes are particularly sensitive to drift from this product. Do not apply when wind direction favors off-target movement onto these crops.

State and Local Requirements

Applicators must follow all state an d local pesticide drift requirements regarding application of 2,4- D herbicides. Where states have more stringent regulations, they must
be observed.

The submitted Enlist Duo label language also requires additional measures to avoid offtarget movement and crop injury, including detailed instructions for clean-out of sprayer equipment, use of drift control additives, and boom and nozzle height instructions.

Additional DAS measures to address spray drift and volatility

As noted above, DAS will contractually require growers of DAS-68416-4 soy who wish to use 2,4- D as an in -crop herbicide to use only Enlist Duo. This new 2,4-D technology will provide substantially lower volatility than any other form of 2,4-D, as well as improved drift control, low odor, and improved handling characteristics.

Through its Technology Use Agreement, DAS will impose a legal and contractual obligation that will require all growers of DAS -68416-4 soybean to:

• Use only EPA accepted and DAS authorized 2,4-D formulations containing Co lex

- D Technology, such as Enlist Duo, for in-crop applications to DAS-68416-4 soybean.

• Read and follow FIFRA Pesticide Product Label directions.

• Read and follow the Enlist Weed Control System Product Use Guide.

• Use properly maintained and calibrated ground application equipment for Enlist Duo
with Colex -D Technology with minimum boom heights.

• Use nozzles that reduce the potential for physical drift of Enlist Duo with Colex- D Technology.

• Follow instructions for equipment clean-out after product use.

DAS will provide comprehensive training on its technology and portfolio of products to growers, dealers and distributors through a variety of formats. Education and training, reinforced through product profiles, technical bulletins, sales literature, direct mailing and websites will also be presented in multiple formats to enhance learning and mastery of core concepts related to stewardship to be employed around DAS-68416-4 soybean. A variety of educational formats willPage 48 be used to promote concept learning. This training will include education on spray technology and herbicide application, including spray quality basics, as well as spray quality of Enlist Duo, as well as how to minimize the potential for off -target movement of Enlist Duo.

Other potential sour ces of off

- target movement

Soil Leaching

2,4- D has a relatively short half

- life and is rather immobile in the soil. In 35 recent field dissipation studies across the U.S., less than 5% of applied 2,4-D moved downward more than 15 cm (6 inches). The avera ge lowest depth detected ranged from 6 to 12 inches in soils of the southern United States, and 16 to 24 inches in low organic soils where greater movement would be expected [ 22 ]. Groundwater detections of 2,4- D, which are very rare, are largely attributed to direct introduction by misuse or spills at well sites [ 23 ]. Proper application and avoiding filling spray equipment near well heads are standard good farming practices that minimize the potential for leaching and work effectively for 2,4- D.

Runoff

Being soluble and having a low to moderate soil adsorption profile provides a moderate potential for 2,4- D to be carried off-site via runoff. The introduction of DAS-68416-4 soybean, on which Enlist Duo herbicide may be used, encourages the adoption of minimum and no- till farming [ 24 ]. Minimizing tillage leaves more crop residue on the soil surface. Crop residue left on the surface significantly reduces runoff by maintaining good soil structure which, in turn, improves the water penetration rate. Additionally, the crop residue slows runoff from starting, allowing time for water to penetrate the soil. The combined effect is a reduction in runoff leaving the field. Farmers are increasingly moving toward no

- till practices for a variety of economic and soil stewardship reasons and the introduction of GT crops facilitated the adoption of no- till practices.
DAS -68416- 4 soybean can help additional farmers adopt more conservation tillage practices and help farmers already using those tillage practices to maintain excellent weed control.Page 49 SECTION 4 : T RAIT S TACKING IN C OMMERCIAL SOYBEANS

Relevant to DAS -68416-4 Draft EA Section 5

Introduction Soybean breeding has an established history of safety. DAS-68416-4 soybean is expected to perform as any conventional or deregulated GE traits in a breeding program. DAS-68416-4 soybean is not considered to be a plant pest; thus, no significant environmental impacts are expected through the use of DAS-68416-4 soybean in breeding programs and in combination with any of the previously deregulated GE soybean products.

All existing and future GE soybean products entering the market have or are expected to satisfactorily complete an FDA consultation process established to review the safety of foods and feeds derived from GE crops for human and animal consumption. DAS-68416- 4 soybean will be
comb ined with a deregulated glyphosate tolerant trait through traditional breeding. As DAS68416-4 soybean has met FDA requirements (BNF #124 1 ), no impacts to public health ( e.g. , food or feed safety) are expected due to combination of DAS-68416-4 soybean with other conventional or deregulated GE.

The analysis below demonstrates that the “approval in whole” and the “no action” alternatives are similar regarding potential cumulat ive impacts associated with the conventional breeding of
DAS -68416-4 soybean with other conventional or GE soybean products.

Discussion The combination of more than one GE trait in a plant variety or hybrid is commonly referred to as a “stack”. There are two basic types of stacks, molecular stacks and breeding stacks, which are defined based on the way the traits are combined. Molecular stacks are created by combining several genes together on the same transformation vector so that the resulting individual transformation event expresses multiple traits. This type of stack always constitutes a new GE event and is subject to the same regul atory oversight by USDA’s Animal and Plant Health Inspection Service (APHIS) as single trait events.

Alternatively, two or more traits may be combined using conventional plant breeding methods to produce breeding stacks. Breeding stacks are created by cross

- fertilizing (or “cross -breeding”) plants containing the individual traits of interest and selecting progeny that contain both traits. Combining traits through breeding does not involve the insertion of new DNA into the genome, does not involve recombinant DNA technology [1] , and is not independently reviewed by
APHIS.

The stacking of traits through cross-breeding has been used for more than a century to combine desirable plant traits in improved lines, and it is this same process that is used today to combine

1 See http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=bioListingPage 50 GE traits in breeding stacks [ 25 ]. During product development, deregulated GE traits are incorporated into breeding programs like any other plant trait, e.g., standability, maturity, pl ant height, etc. Plant breeders work to combine many different traits through cross-breeding, both native and GE traits, to produce lines with the specific qualities growers need to optimize yield. Several GE soybean products have been deregulated or are pending deregulation by the USDAAPHIS. These include soybean traits such as phosphinothricin tolerance, glyphosate tolerance, glyphosate and acetolactate synthase tolerance, and insect resistance. 2

DAS -68416-4 soybean may be stacked using conventional breeding with other deregulated GE soybean traits as well as with conventional soybean varieties. Previously deregulated GE soybeans and progeny from crosses of these varieties with conventional or deregulated GE varieties have been determined by APHIS to n ot present a plant pest risk or display characteristics that constitute a significant impact on the human environment.

A large and growing number of stacked GE products in a variety of crops have been produced safely on millions of acres without incident over the past decade in both the US (over 30 products) and in other countries 3 . In 2011, 49% of the total US corn acres planted (92 M acres) and 58% of total US cotton planted (13M acres) contained multiple (2 or more) GE events (USDA -ERS, 2011) 4 . The ove rall safety of these stacked GE products is well established [1]

.

APHIS Regulatory Oversight and Authority Concerning Trait Stacks

The Plant Protection Act (PPA) and 7 CFR Part 340 grant APHIS authority to regulate plants that do or may pose plant pest risks, including GE plants. Based on APHIS’s review of data submitted by a petitioner, APHIS may determine that a GE plant does not pose more of a plant pest risk than a conventionally bred plant of the same species. (7 CFR 340.6) Among the data
on which APHIS bases such a determination of non- regulated status (deregulation) are Mendelian inheritance data and Chi square analysis of segregation ratios for at least two generations to demonstrate that the transgene is stably inserted and inherited in Mendeli an fashion [ 26 ]. This demonstration of stable integration and heritability provides assurance that all general theories of plant breeding will apply equally to GE plants that have successfully completed this review.

In the act of deregulating GE plants, APHIS determines that the GE plant does not pose a plant pest risk, and by doing so, releases that plant from the agency’s PPA and Part 340 authority. Thus, following deregulation, APHIS’ authority over GE stacks is no different than its authority over any other cross-bred plants. As long as the resulting off-spring plant is not found to pose a PPA risk, further APHIS oversight is neither necessary nor authorized. APHIS has previously described its regulatory authority over stacks as the following [ 27 ] ;

2 See http://www.aphis.usda.gov/biotechnology/not_reg.html

. Petitions o f Nonregulated Status Granted or Pending by APHIS

3 See http:// www.biotradestatus.com for list of combined trait products that have previously been commercialized.

4 See http://www.ers.usda.gov/data/biotechcrops/adoption.htmPage 51 APHIS’ regulations at 7 CFR Part 340 do not provide for Agency oversight of GE varieties that are no longer subject to the plant pest provisions of the Plant Protection Act and 7 CFR part 340, nor over stacked varieties combining GE varieties that are no longer subject to the plant pest provisions of the Plant Protection Act and 7 CFR part 340 unless it can be positively shown that such stacked varieties were to pose a likely plant pest risk.

Furthermore, other regulatory agencies have adopted similar positions regarding breeding stacks of prev iously approved GE events. A s described in Pilacinski et al. [ 25 ] :

“...regulatory agencies in some countries, including the U.S. (FDA, 2001), Canada (CFIA, 2004), and Australia (OGTR, 2007), have requested no additional regulatory data to approve combined [GE] events as long as the traits are not likely to interact in a manner that would affect safety and the risk assessments of the single events can reasonably be applied to the combined event produ ct.”

Federal Government Statements Supporting Safety of Cross

- breeding

In its policy statement setting forth its views on the safety of foods developed from GE crops, the United States Food and Drug Administration (FDA) spoke at length regarding the relatively low food safety risks posed by all forms of genetic modification, including traditional plant breeding and GE technology. 57 Fed. Reg. 22984 (May 29, 1992). This safety is assured, in part, by the
careful and time -honored breeding practices of plant breeders, the multiple generations of breeding that takes place prior to marketing, and the long history of genetic stability in crossbred crops. The same factors hold true for the environmental, agronomic, or any other effects of

cross -breeding, or stacking, of GE traits [ 28 ] . Specifically, FDA stated:

Plant breeding is the science of combining desirable genetic traits into a variety th at can be used in agriculture. The desired traits can be broadly divided into two classes: Those that affect agronomic characteristics of the plant, and those that affect quality characteristics of the food. Agronomic characteristics include those affecting yield; resistance to diseases, insects, and herbicides; and ability to thrive under various adverse environmental conditions. Quality characteristics include those affecting processing, preservation, nutrition, and flavor.

The genetic modification techniques used to develop new plant varieties constitute a continuum. Traditional breeding typically consists of hybridization between varieties of the same species and screening for progeny with desired characteristics. Such hybridizations only can introduce traits found in close relatives. Breeders have developed or adopted a number of techniques to expand the range of genetic variation available to them. These techniques introduce variation either by using mutagenesis to alterPage 52 the genome or by introducing or modifying DNA segments, including DNA segments derived from other organisms. Mutagenic techniques include both random mutagenesis, resulting from treatment with chemical and physical mutagens, and somaclonal variation, whereby, with the use of tis sue culture techniques, plants are regenerated from callus or leaf tissue explants. The regenerated plants often have properties not found in the progenitor plant, reflecting both preexisting cellular genetic
differences and tissue -culture induced mutations. The mutations range from single gene changes to chromosomal rearrangements. Mutagenesis techniques are limited, however, by their inability to target a desired trait. Somaclonal variants also frequently are
unstable or infertile.

Techniques for gene transfer between plants that belong to different species or genera fall under the general heading of “wide crosses.” These “crosses” have been accomplished using hybridization, and protoplast fusion. Traditional wide crosses involve hybridization betwee n closely related species or genera, frequently requiring the use of special techniques such as embryo rescue and chromosome doubling to overcome physical or genetic barriers to the production of fertile progeny. They permit the transfer of genetic traits that are not present in close relatives of the modern plant varieties but are found in more distant wild
relatives. Traits that confer resistance to a number of diseases have been introduced this way.

All of the techniques described above require extens ive back crossing with the parent line [FN4] to eliminate mutations unlinked to that responsible for the desired phenotype and undesirable traits in extraneous genetic material introduced along with that encoding the desired
trait.

FN4 A line is a group of individuals from a common ancestry. It is a more narrowly defined group than a variety. (Breeding Field Crops, J.M. Poehlman, Van Nostrand Reinhold, New York, 1987).

. . .

Regardless of the particular combination of techniques used, the development o f a new plant variety typically will require many site -years (number of sites x number of years of plant testing) of performance trials before introductionPage 53 into agricultural practice. These range from as few as 10 to 20 site-years for some plants to 75 to 100 site- years for others (some 5 to 10 years). The time of evaluation and the size and number of sites will vary as necessary to confirm performance; to reveal vulnerabilities to pests, diseases, or other production hazards; to evaluate stability of the phenotype; to evaluate characteristics of the food; to evaluate environmental effects; and to produce the required amount of seed before the new plant variety can be grown commercially by farmers. In the course of this intensive assessment, individual pl ants exhibiting undesirable traits
are eliminated.

Any genetic modification technique has the potential to alter the composition of food in a manner relevant to food safety, although, based on experience, the likelihood of a safety hazard is typically ver y low.

. . .

Virtually all breeding techniques have potential to create unexpected (including pleiotropic [FN5]) effects. For example, mutations unrelated to the desired modification may be induced; undesirable traits may be introduced along with the desired traits;

n ewly introduced DNA may physically insert into a transcriptionally active site on the chromosome, and may thereby inactivate a host gene or alter control of its expression; the introduced gene product or a metabolic product affected by the genetic change m ay interact with other cellular products to produce a deleterious effect. Plant breeders using well established practices have successfully identified and eliminated plants that exhibit unexpected, adverse traits prior to commercial use.

FN5 Pleiotropic effects refer to multiple effects resulting from a single genetic change.

57 Fed. Reg. at 22985-87.

The United States Environmental Protection Agency (EPA), which regulates GE crops that have been engineered to produce their own pesticide, known as plant-incorporated protectants (PIPs), has also assessed the food and environmental risks associated with traditional plant breeding.

For example, EPA has stated the following in the context of exempting from EPA regulation PIPs produced through traditional plant breeding:Page 54 EPA recognized and relied on the long history of human experience with growing and consuming plants for food and with the procedures of plant breeding. Plant breeding combines the scientific knowledge of experimental laboratory discipline s such as plant physiology, plant genetics, and phytopathology into a practical field science that develops new plant cultivars for use in agriculture. EPA has used these bases of knowledge and experience in its estimation of exposures and hazards of the residues of pesticidal substances addressed by this supplemental notice as well as for the 1994 [rulemaking] proposal.

EPA concluded in the 1994 proposal (59 FR 60535) that the vast majority of plant varieties developed by plant breeders using traits
from sexually compatible plants produce foods that are safe for human consumption. This conclusion is based on the experience of consuming crops resulting from scientific breeding as well as the historical consumption of crops since the prehistorical origins of agriculture. These foods undoubtedly contain(ed) pesticidal substances (and the genetic material necessary to produce them) and share a history of safe consumption. In addition, appropriate processing procedures are widely known and are routinely used by consumers in preparation of food from such sources, including those foods which require specific processing/preparation steps to avoid dietary problems.

In the 1994 proposal, EPA stated that many substances having pesticidal activity occur naturally a t low concentrations in the edible parts of plants and have long been accepted as part of the human diet. Extensive use and experience show the safety offoods containing these substances. For many foods, the naturallyoccurring toxicants they may contain, some of which might be pesticidal in function, are known. Also, the established practices that plant breeders employ in selecting and developing new plant varieties, such as chemical analyses, taste -testing, and visual analyses, have historically prove n to be reliable for ensuring food safety. That there are few documented cases of new plant cultivars causing food safety problems despite the large numbers of new varieties introduced into commerce each year, is a reflection of the
effectiveness of this process (59 FR at 60538).

Plant varieties for the food market have been developed by breeders seeking better products, higher yields, and other desirable crop characteristics. In this process, it has been common agricultural practice to move traits among sexually compatible food plant varieties as well as to introduce traits from sexually compatible wild relatives into plant varieties that are used as food plants. This type of breeding process has been usedPage 55 on most sexually compatible crop plants, and te nded to increase the extent of relatedness among plant varieties in agricultural crops. The 1994 proposal is based on experience with the exposure of human populations to crops developed through the breeding process, i.e., crops developed through 50 to 10 0 years of scientific breeding among sexually compatible plant populations using Mendelian genetics. The sexually compatible, wild relatives of cultivated plants that are used in this process do not themselves necessarily have any history of human consumption but have safely contributed traits through sexual recombination to cultivars on the market. For example, wild species of tomatoes have been used, in plant breeding, as a source of increased resistance to economically important diseases in tomato (Ref . 1). Sexually compatible crop varieties of the same plant species are also crossed with each other to achieve better pest resistance in their progeny. Food plant varieties developed in this way have been introduced, cultivated, and consumed by humans fo r many years with very few observed adverse affects (59 FR at 60538).

62 FR 27132, 27134-35 (May 16, 1997).

EPA wrote earlier on the same topic:

Sexually compatible plants are more apt to share traits than are unrelated plants. It is a common expectation that similarity is associated with the degree of relatedness. Natural hybridization and selection have produced groups of plants which have a common gene pool. Generations of artificial hybridization practiced to produce improved crops for cultivation have tended to increase the extent of relatedness among elements of a broader segment of agricultural plants.

The practice of saving seed from desirable plants has been going on for thousands of years and controlled crosses to produce plant hybr ids have been documented since the eighteenth century. Since the rediscovery of Mendel's work on the inheritance of traits, there is a base of experience of 50 to 100 years of breeding for most major crops. During that time, it has been common agricultur al practice to cross sexually compatible wild relatives with crop plants to develop crop varieties with better pest resistance. Techniques such as genetic mapping reveal the presence of genetic loci in cultivated plants that previously were considered to be present only in the wild species. Sexually compatible crop varieties are also crossed with each other to achieve better pest resistance in their progeny. Because of these common practices, the potential for significantly different environmental exposu res from current crop plants is likely to be low.Page 56 59 FR 60519, 60523 (Nov. 23, 1994).

In developing its own regulations for GE plants, APHIS has also repeatedly recognized the crop safety inherent in traditional breeding programs, and excluded them from regulation:

An examination of the literature describing the techniques used in genetics prior to the introduction of recombinant DNA technology finds that many techniques other than interspecific crosses have been in common use. The transfer of genetic t raits by methods such as protoplast, cell, and embryo fusion, and mutagenesis has been an accepted part of genetics for some years prior to the development of various recombinant DNA technologies for the movement of genes. It would thus seem that the techniques in question should properly be included as a part of classical genetics, and excluded from the definition of "genetic engineering."

52 Fed. Reg. 22892, 22894 (June 16, 1987) (finalizing Part 340).

Any risk posed by the introduction into the environment of a regulated article under the notification procedures is likely to be comparable to the risks posed by plants developed through more traditional plant breeding techniques. Over the years, plant breeders have developed standard agricultural prac tices to address these risks, and the Agency believes that such practices will be adequate to address any risk from plants introduced under this rule.

57 Fed. Reg. 53036, 53038 (Nov. 6, 1992) (amending Part 340)

These century -old principles of breeding support APHIS’s regulatory position that cross-breeding, or stacking, of GE crops, through conventional breeding methods, with other sexually compatible plants, follows the same Mendelian patterns of heritability as other conventional breeding. Moreover, nothing in the decades of field testing and commercialization of GE crops has shown any indication that these theories of breeding do not hold true for GE plants. In short, there is no reason to believe that stacking, or cross-breeding, of deregulated GE plants would pose any health, safety or environmental risks different than risks posed by any other crop cross- breeding.

Stacked Trait Combinations with DAS -68416-4 Soybean

Soybean lines that contain herbicide-tolerance traits (glyphosate) have been on th e market since 1996 and have experienced broad adoption ( see DAS -68416- 4 soybean petition, USDA Petition # 09-349-01p). The adoption track record of biotechnology-derived soybean represents the most rapid case of technology adoption in the history of agriculture [ 29 ]. Based on USDA survey data,Page 57 herbicide-tolerant soybeans (glyphosate-tolerant) went from 17 percent of U.S. soybean acreage in 1997 to 68 percent in 2001 and 93 percent in 2012 [ 30 ]. Glyphosate has provided simple, inexpensive, and highly effective weed control and has resulted in an increase in no- till soybean production, a practice that is now accepted as improving soil health and agricultural
sustainabili ty.

With 93% of soybean acres in the U.S. in 2009 planted to glyphosate-tolerant soybeans, typical cultivation and management practices used by growers today already take into account the management of herbicide

- tolerant traits. It is anticipated that th e same management practices used today for soybeans with the glyphosate- tolerance trait will also be appropriate for DAS

68416- 4 soybean.

DAS -68416-4 soybean stacked with glyphosate- tolerance traits will have the potential to improve weed control by allowing use of herbicide combinations or mixtures which can provide more consistent performance in post-emergence weed control programs, and counteract glyphosate “rate

- creep” (steady increase in rates needed to obtain effective weed control) on
hard

- to -contr ol weeds [ 31 ] . DAS -68416-4 soybean, which is tolerant to 2,4- D, will allow use of a low cost, high performance solution to reduce the escalation of glyphosate- and ALS- resistance in weed populations.

DAS intends to stack DAS-68416- 4 soybean with soybean that has been genetically engineered to be tolerant of glyphosate. APHIS has granted determinations of non-regulated status for

mu ltiple glyphosate- tolerant soybean products, each accompanied by an environmental assessment under the National Environmental Policy Act (NEPA) which, in each instan ce, supported a finding of no significant impact (FONSI). APHIS undertook an extensive assessment of glyphosate, and EPA’s regulation of the herbicide, in its recent Environmental Impact Statement prepared in association with APHIS’s determination of non -regulated status of GT alfalfa events J101 and J163 [ 32 ].

Summary Soybean breeding has an established history of safety, and DAS-68416- 4 soybean is expected to perform in a fashion analogous to any conventional or deregulated GE traits in such a breeding program. Since DAS-68416-4 soybean is not considered to be a plant pest, no significant environmental impacts are expected through the use of DAS-68416-4 soybean in breeding programs and in combination with any of the previously deregulated GE soybean products.

All existing and future GE soybean products entering the market have or are expected to satisfactorily complete an FDA consultation process established to review the safety of foods and feeds derived from GE crops for human and animal consumption. DAS-68416- 4 soybean is intended to be combined with a deregulated glyphosate tolerant trait through traditional breeding. No impacts are expected due to combination of DAS-68416-4 soybean with other conventional or deregulated GE.

Based on the above analysis, the approval in whole and no action alternatives are similar regarding potential cumulative impacts associated with the conventional breeding of
DAS -68416-4 soybean with other conventional or GE soybean products.