Supplemental Information for Petition for Determination of Non-regulated Status for

Herbicide Tolerant DAS-68416-4 Soybean

Stewardship of Herbicide Tolerant Trait Technology for DAS-68416-4 Soybean

The undersigned submits this information under 7 CFR 340.6 to support the 

determination that the article should not be regulated under 7 CFR 340.

Submitting Company:

Dow AgroSciences LLC

Submitted by:

__________________________________

Mark Krieger

Regulatory Leader

Regulatory Sciences & Government Affairs

Dow AgroSciences LLC

9330 Zionsville Road

Indianapolis, IN 46268

Telephone: (317) 337-3458

FAX: (317) 337-4649

mkrieger2@dow.com

June 24, 2011
Supplemental Information for USDA Petition for Nonregulated Status of DAS-68416-4 Soybean Page 2 of 12 

Dow AgroSciences LLC

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 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.
Supplemental Information for USDA Petition for Nonregulated Status of DAS-68416-4 Soybean Page 3 of 12 

Dow AgroSciences LLC

Stewardship of Herbicide Tolerant Trait Technology for DAS-68416-4 

Soybean

Table of Contents

1. Introduction ________________________________________________________ 4

2. Stewardship Goals ___________________________________________________ 4

3. Stewardship Program Components _____________________________________ 5

3.1 Authorized Use Through Grower Agreements 

3.2 2,4-D Choline Herbicide Technology 

3.3 Comprehensive Product Use Information

3.3.1 Product Use Guides

3.3.2 Product Labels, Seed Bags and Tags

3.3.3 Technical Bulletins

3.3.4 Product Literature and Direct Mailings

3.3.5 Internet Resources 

3.4 Education and Training for Retailers, Growers and Applicators

3.5 Compliance Monitoring 

4. Stakeholder Outreach and Input ______________________________________ 10

5. Industry Commitment and Involvement ________________________________ 11

6. Conclusion ________________________________________________________ 11

7. References ________________________________________________________ 12
Supplemental Information for USDA Petition for Nonregulated Status of DAS-68416-4 Soybean Page 4 of 12 

Dow AgroSciences LLC

Stewardship of Herbicide Tolerant Trait Technology for DAS-68416-4 

Soybean

1. Introduction

DAS-68416-4 Soybean is a transgenic soybean product that provides tolerance to 2,4-

dichlorophenoxyacetic acid (2,4-D) and glufosinate. This herbicide-tolerant soybean will 

provide growers with greater flexibility in selection of herbicides for the improved 

control of economically important weeds; allow an increased application window for

effective weed control; and provide an effective resistance management prevention 

solution to the increased incidence of hard-to-control and glyphosate resistant weeds1. 

Dow AgroSciences is committed to promoting the responsible use and stewardship of this 

new herbicide tolerant trait technology and will implement a comprehensive stewardship 

program for DAS-68416-4 soybean and its associated herbicide technology containing a 

new 2,4-D choline salt. The stewardship program will focus on educating and training 

retailers, growers and applicators on the appropriate use of this new technology. This 

will be accomplished by using a multi-faceted approach, including use of a variety of 

tools and delivery methods, and working with customers, stakeholders and industry 

organizations to promote responsible use of the technology (Dietz, 2010). 

2. Stewardship Goals

Specific goals of Dow AgroSciences’ comprehensive stewardship program for DAS68416-4 soybean and 2,4-D choline salt include:

 Promoting the responsible use of this new technology to sustain its viability,

 Promoting compatibility with other crops and cropping systems,

 Providing distributors, retailers, growers, and applicators comprehensive guidance 

on responsible technology use, and

 Supporting compliance with state and federal regulatory requirements.

 

1

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.
Supplemental Information for USDA Petition for Nonregulated Status of DAS-68416-4 Soybean Page 5 of 12 

Dow AgroSciences LLC

3. Stewardship Program Components

To meet the above-described stewardship goals, Dow AgroSciences is developing a 

comprehensive stewardship program based on its experience and input from stakeholders. 

Key components of the stewardship program include:

 Authorized use through grower agreements,

 New 2,4-D choline based herbicide technologies, 

 Comprehensive product use information,

 Education and training, and

 Compliance monitoring.

3.1 Authorized Use Through Grower Agreements 

Growers who purchase and plant DAS-68416-4 soybeans containing this new herbicide 

tolerant trait technology will be required to sign a grower agreement that provides the 

terms and conditions for the authorized use of the technology. The grower agreement 

will include a provision requiring them to follow the product use guide and all pesticide 

label requirements. 

3.2 2,4-D Choline Herbicide Technology

Dow AgroSciences has discovered and developed a novel (non-ester or non-amine) 

2,4-D choline salt herbicide product for use with DAS-68416-4 soybean. New herbicide 

formulations containing the active ingredient, 2,4-D choline salt2, are focused on 

improving non-target crop and environmental safety by offering growers and applicators 

herbicide products with ultra low volatility and minimized potential for physical drift. 

An exceptionally low volatility of 2,4-D choline salt has been demonstrated in both

laboratory studies and preliminary field studies. For example, in a laboratory study, 

wheat plants treated with rates ten times higher than specified on the label of 2,4-D 

choline were placed in an enclosed chamber with grape and tomato plants (Ouse et al., 

2010). After 24 hours of exposure in the chamber at 104°F, neither sensitive crop 

showed any symptoms of injury. The lack of any symptoms on the grape and tomato 

plants is a clear indication that there was no detectable volatility following application of

2,4-D choline salt. Preliminary field results are consistent with these laboratory findings

(Hillger et al., 2010).

 

2

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 use with DAS-68416-4 

soybean is currently under EPA review.
Supplemental Information for USDA Petition for Nonregulated Status of DAS-68416-4 Soybean Page 6 of 12 

Dow AgroSciences LLC

Dow AgroSciences is also developing an innovative premix formulation that combines 

2,4-D choline with glyphosate for use with DAS-68416-4 soybean.

3

 As compared to tank 

mixes of traditional 2,4-D products and commercial glyphosate, this premix uses

formulation technologies that will result in a significant reduction in herbicide off-target 

movement from particle drift (Wilson et al., 2010). This premix product will reduce the 

potential for off-target movement from both particle drift and volatility.

3.3 Comprehensive Product Use Information

3.3.1 Product Use Guides

Dow AgroSciences will establish product use guidelines and educate the technology 

users on responsible use via channel partner standards and agreements, grower 

agreements and product use guides. The product use guide will require that growers only 

use authorized 2,4-D choline products for use with soybeans containing this new 

herbicide tolerant trait technology. It will include information on herbicide resistance 

management, application and management of off-target herbicide movement, as well as 

seed planting directions and grain stewardship. 

3.3.1.1 Herbicide Resistance Management

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 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. 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 labeled 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 

practices:

 

3 An application for 2,4-D choline and glyphosate premix use with DAS-68416-4 soybean will be submitted 

to EPA shortly.
Supplemental Information for USDA Petition for Nonregulated Status of DAS-68416-4 Soybean Page 7 of 12 

Dow AgroSciences LLC

Herbicide Selection

 Rotate the use of 2,4-D choline salt with non-auxin (non-Group 4) herbicides. 

 Utilize a broad spectrum soil-applied herbicide as a foundation treatment.

 Utilize premixes, tank mixes or sequential applications of herbicides with 

alternative modes of action. 

 Avoid using more than two applications of a Group 4 herbicide, such as 2,4-D 

choline salt, within a single growing season unless mixed with another mode of 

action herbicide with overlapping spectrum. 

 Apply full rates of 2,4-D choline sale 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 integrated 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 the local retailer, county extension agent, or Dow 

AgroSciences representative. 

3.3.1.2 Herbicide Application and Management of Off-Target Movement 

The new 2,4-D choline containing herbicide products will minimize off target movement 

by reducing volatility and, in the case of the glyphosate + 2,4-D choline premix, off target 

movement will be minimized by reducing volatility and reducing the number of driftable 

fines.

To further minimize the potential for off-target movement with the new 2,4-D choline 

containing herbicide products, the product use guide will include recommendations on 

application equipment and methods such as following proper equipment maintenance, 

calibration and use. 

A variety of factors including weather conditions (e.g., wind direction, wind speed, 

temperature, and relative humidity) and method of application can influence pesticide 
Supplemental Information for USDA Petition for Nonregulated Status of DAS-68416-4 Soybean Page 8 of 12 

Dow AgroSciences LLC

drift. Product use guides will require applicators to evaluate factors and make 

appropriate adjustments when applying 2,4-D choline salt for use with DAS-68416-4 

soybean consistent with the final product label approved by EPA. Dow AgroSciences is 

conducting significant research on nozzles for spray application. The product use guide 

will include instructions on using specific nozzles that minimize driftable spray droplets, 

specified environmental conditions such as wind speed and field temperature that 

minimize the potential for off-target movement due to particle or vapor drift. 

3.3.2 Product Labels, Seed Bags and Tags 

3.3.2.1 Product Labels

Dow AgroSciences has submitted a product label to EPA that includes comprehensive 

information and requirements for responsible use of 2,4-D choline with DAS-68416-4 

soybean. Such label directions are designed to minimize the potential for weed resistance 

development and off-target movement of 2,4-D choline. In addition, the submitted label 

does not allow herbicide application through any type of irrigation equipment and 

prohibits aerial application. 

3.3.2.2 Seed Bags and Tags 

Seed bags and tags of soybean seed containing this new herbicide tolerant trait 

technology will have tags that provide stewardship information such as where to find the 

product use guide and grower agreement, as well as a customer information telephone 

number. Herbicide icons have been developed and will be included in marketing 

materials to clearly communicate applicable herbicide requirements to growers. When 

growers order seed, the icons and information will be included in the product use guide 

and on product fact sheets. Icons will appear on seed bag tags to remind growers of 

herbicide requirements at the time of planting.

3.3.3 Technical Bulletins 

Dow AgroSciences will create comprehensive technical bulletins on these products 

including elements that address weed resistance management strategies, herbicide 

application technologies, responsible application practices to reduce the potential for offtarget herbicide movement, and education on other elements of the herbicide label. Dow 

AgroSciences will make these available to channel and grower customers. They will also 

be made available to university cooperators, agronomists, crop consultants, other 

technical professionals and the general public through publication on internet websites.

3.3.4 Product Literature and Direct Mailings 

Dow AgroSciences will also position the herbicide tolerant trait technology and promote

its responsible use in its product literature by including crop agronomy, weed 

management, herbicide use and application information. Dow AgroSciences commonly 

uses direct mailings to customers, and will promote responsible stewardship of the 
Supplemental Information for USDA Petition for Nonregulated Status of DAS-68416-4 Soybean Page 9 of 12 

Dow AgroSciences LLC

herbicide tolerant trait technology through newsletters and correspondence. These direct 

mailings will emphasize responsible use practices, label compliance, weed resistance 

management, and application guidance to minimize the potential for off-target 

movement. 

3.3.5 Internet Resources 

Information on the technology including agronomic and proper product placement, 

specific guidelines for planting transgenic traits, and herbicide use and application will be 

made available on technology provider websites. Relevant industry and university links 

may also be included to provide the user with additional technical information. Dow 

AgroSciences provides product stewardship information on its corporate and product 

websites.

3.4 Education and Training for Retailers, Growers and Applicators

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 technology and 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. 

Dow AgroSciences will communicate to customers the importance of stewardship and 

responsible product use. Dow AgroSciences will utilize a variety of approaches to 

educate and train retailers, growers, and applicators. These will include written 

communications, face-to-face meetings, field visits, television, radio, and/or computerbased training such as webinars and self-paced learning modules. Product stewardship 

plans for the herbicide tolerant trait technology will be based on applicator, grower and 

grain channel education, with reinforcement through written and verbal communications, 

including grower agreements, product use guides, product profiles, technical bulletins, 

sales literature, direct mailings, and websites.

Education topics for retailers, growers and applicators will include: DAS-68416-4 

soybean trait technology (including herbicide tolerance and agronomic practices), 2,4-D 

choline herbicide solutions (including label education, weed resistance management and 

herbicide application practices to minimize off-target movement). As an example, weed 

resistance management training will include information on: 

 The value of rotating herbicides with different modes of action, 

 How to use herbicides with different modes of action to achieve effective weed 

control,

 Recommendations to follow all labeled application rates and recommendations, 

 How to apply herbicides at the proper weed size or growth stage, and
Supplemental Information for USDA Petition for Nonregulated Status of DAS-68416-4 Soybean Page 10 of 12 

Dow AgroSciences LLC

 Appropriate cultural and mechanical practices for weed control and weed 

resistance management.

As part of the various delivery methods and tools to educate retailers, growers, and 

applicators on the responsible use of this technology, Dow AgroSciences will use an 

online, interactive Learning Management System that will include training modules and 

information targeted to the users of the technology.

3.5 Compliance Monitoring 

Dow AgroSciences is committed to implementing a compliance monitoring program for 

DAS-68416-4 soybean and its associated new 2,4-D choline herbicide technology. The 

monitoring program will be developed for retailers, growers, and applicators to promote 

responsible use of the technology. 

Compliance with the grower agreement and product use guides will be tracked and 

monitored through surveys, communications, and on-farm visits. Failure to follow the 

requirements set forth in the grower agreement and product use guide may result in the 

loss of a grower’s access to the technology. The grower agreement to be signed by the 

grower will require that upon request by Dow AgroSciences, the grower must provide 

information indicating the location of all fields planted with DAS-68416-4 soybean and 

the herbicide applied to these fields. In addition, the grower will be required to cooperate 

with any on-farm visits and field inspections. 

4. Stakeholder Outreach and Input

Dow AgroSciences is using a variety of methods to obtain stakeholder input in the 

development of this product 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 for this technology 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.
Supplemental Information for USDA Petition for Nonregulated Status of DAS-68416-4 Soybean Page 11 of 12 

Dow AgroSciences LLC

5. Industry Commitment and Involvement 

Dow AgroSciences participates in several organizations 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) [http://www.hracglobal.com], an industry-based group supported by CropLife 

International [http://www.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 [http://www.wssa.net/Weeds/Resistance/] issues. Dow 

AgroSciences conducts joint trials at university sites as well as seeking input from 

university researchers regarding weed management. Dow AgroSciences also participates

in a wide range of professional organizations including agronomy societies, seed trade 

groups, weed science societies, and crop commodity groups.

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 trait product’s life cycle. 

6. Conclusion

Dow AgroSciences is committed to promoting the responsible use and stewardship of this 

new herbicide tolerant trait technology and will implement a comprehensive stewardship 

program for DAS-68416-4 soybean and its associated new herbicide technology, 2,4-D 

choline salt. The stewardship program will focus on educating and training retailers, 

growers and applicators on the appropriate use of this new technology. This will be 

accomplished by using a multi-faceted approach, including use of a variety of tools and 

delivery methods, and working with customers, stakeholders and industry organizations 

to promote responsible use of the technology.
Supplemental Information for USDA Petition for Nonregulated Status of DAS-68416-4 Soybean Page 12 of 12 

Dow AgroSciences LLC

7. References

Dietz, K. (2010). DHT - Managing the Performance, Minimizing the Risk. Proceedings 

of the 2010 North Central Weed Science Society. Volume 65. http://ncwss.org/

Ouse, D.G., Gifford, J.M., Ahmed, A.A. and Jennings, C.J. (2010). Laboratory 

Evaluations of New Forms of 2,4-D for Volatility and Potential to Damage Non-Target 

Plants. Proceedings of the 2010 North Central Weed Science Society. Volume 65.

http://ncwss.org/

Hillger, D.E., Havens, P.L., Simpson, D.M. and Braxton, B. Field Methods for 

Evaluation of Herbicide Volatility. Proceedings of the 2010 North Central Weed Science 

Society. Volume 65. http://ncwss.org/

Wilson, S.L., Qin, K. and Downer, B. (2010). Reducing Herbicide Particle Drift with 

Combinations of Application Equipment and Herbicide Formulation Innovations. 

Proceedings of the 2010 North Central Weed Science Society. Volume 65.

http://ncwss.org/