Supplemental Information for Petition for Determination of Nonregulated Status for Herbicide Tolerant DAS - 68416 - 4 Soybean Regulatory Overview of 2,4 - D and Glufosinate Use on 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 b y:

__________________________________

Mark S. Krieger Regulatory Leader Regulatory Sciences & Government Affairs Dow AgroSciences LLC 9330 Zionsville Road Indianapolis, IN 46268 Telephone: (317) 337

- 3 458 FAX: (317) 337

- 4649 mkrieger2 @dow.com

June 24 , 2011Supplemental Information for USDA Petition for Nonregulated Status of DAS

- 68416

- 4Soybean Page 2 of 13

Regulatory Overview of 2,4

- D and Glufosinate Used on DAS

- 68416

- 4 Soybean 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

. This document provides information pertaining to the regulation of the use of 2,4

- D and glufosinate on DAS

- 68416

- 4 soybean . This information includes:

o Descript ion of the responsibilities of various agencies of the U

. S

. government with respect to pesticide registration and use. o Comparison of the current and proposed new use patterns for 2,4

- D and glufosinate on soybean

. o Evaluation of the current environmental ri sk assessments for 2,4

- D and glufosinate relative to the proposed new use patterns.Supplemental Information for USDA Petition for Nonregulated Status of DAS

- 68416

- 4Soybean Page 3 of 13

Regulatory Overview of 2,4

- D and Glufosinate Used on DAS

- 68416

- 4 Soybean Table of Contents 1 Regulatory Oversight of Pesticides in the United States

................................ ........................ 4 1.1 Coordinated Framework for the Regulation of Biotechnology

................................ ........ 4 1.2 Environmental Protection Agency

................................ ................................ ................... 4 1.2.1 FIFRA

................................ ................................ ................................ ....................... 4 1.2.2 Registration Review

................................ ................................ ................................ .. 5 1.2.3 FIFRA Enforcement

................................ ................................ ................................ .. 5 1.2.4 FFDCA

................................ ................................ ................................ ...................... 5 1.2.5 Pesticide Risk A ssessment at EPA

................................ ................................ ........... 5 1.2.5.1 Human Health and Ecological Pesticide Risk Assessment at EPA

................... 5 1.2.5.2 Cumulative and Aggregate Human Health Risk Assessments under FQPA

..... 6 1.3 Endangered Species Act

................................ ................................ ................................ ... 6 1.3.1 EPA Responsibilities

................................ ................................ ................................ 7 1.3.2 Effects Determinations

................................ ................................ .............................. 7 1.3.3 Consultation with the Service

................................ ................................ ................... 7 1.3.4 Implementing Measures to Protect Listed Species

................................ ................... 8 1.4 Non

- Federal Regulatory Oversight of Pesticides

................................ ............................. 8 2 Regulatory Status of 2,4

- D and Glufosinate at EPA

................................ ............................... 9 2.1 2,4

- D

................................ ................................ ................................ ................................ . 9 2.2 Glufosinate

................................ ................................ ................................ ....................... 9 2.3 Legal Challeng es to EPA Decisions

................................ ................................ ............... 10 3 Existing and Proposed Use Patterns

................................ ................................ ..................... 11 3.1 2,4

- D

................................ ................................ ................................ ............................... 11 3.2 Glufosinate

................................ ................................ ................................ ..................... 12 4 Environmental Risk Assessment

................................ ................................ ........................... 12 4.1 2,4

- D

................................ ................................ ................................ ............................... 12 4.2 Glufosinate

................................ ................................ ................................ ..................... 13Supplemental Information for USDA Petition for Nonregulated Status of DAS

- 68416

- 4Soybean Page 4 of 13

Regulatory Overview of 2,4

- D and Glufosinate Used on DAS

- 68416

- 4 Soybean 1 Regulatory Oversight of Pesticides in the United States 1.1 Coordinated Framework for the Regulation of Biotechnology The U

. S

. government established the Coordinated Framework for the Regula tion of Biotechnology 1 in 1986. The Coordinated Framework specifies the division of responsibility and coordination of activities between the agencies of the federal government involved with regulation of genetically engineered crops. Each agency maintains separate decision

- making power within its sphere of authority. Under the Coordinated Framework, t he U.S. Department of Agriculture's Animal and Plant Health Inspection Service (USDA

- APHIS) will make a decision whether or not to deregulate DAS

- 68416

- 4 soy bean. Separately, and independent of the Coordinated Framework, the U S Environmental Protection Agency (EPA) will make a decision whether or not to approve registration for specific use patterns of 2,4

- D and/or glufosinate on DAS

- 68416

- 4 soybean pursuant to its authority under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to register pesticides for use in the United States. 2 These two decisions are independent, statutorily enumerated events. 1.2 Environmental Protection Agency 1.2.1 FIFRA The EPA regulates the use of herbicides, including 2,4

- D and glufosinate , under FIFRA. FIFRA requires that registration of a pesticide for a specific use be obtained from the EPA prior to distribution or sale of the pesticide for that use pattern. Before registering a new use for a new or previously registered pesticide, EPA m ust ensure that the pesticide, when used according to label directions, will not cause unreasonable adverse effects on the environment. In order to address this standard, EPA must evaluate potential risks to humans and the environment, and may require appl icants to submit more than 100 different scientific studies and tests conducted according to EPA guidelines. EPA regulates both pesticidal active ingredients as well as end

- use formulated products. The data required by EPA are used to evaluate whether a p esticide has the potential to cause adverse effects on humans, wildlife, fish, and plants (including endangered species and “non

target” organisms

– organisms that the pesticide is not intended to act against). The registration applicant must also supply d ata addressing the pesticide’s potential impact on surface water and ground water. Potential human health and safety risks that are assessed range from short

- term toxicity to long

- term effects such as cancer and reproductive system disorders. Based on its assessment of a pesticide’s potential health and environmental effects, EPA registers the pesticide and approves the language that appears on the pesticide product label regarding the new use.

1 http://usbiotechreg.nbii.gov/ 2 http://www.epa.gov/pesticides/about/aboutus.htm , 7 U.S.C. §§ 136

- 136y.Supplemental Information for USDA Petition for Nonregulated Status of DAS

- 68416

- 4Soybean Page 5 of 13

Regulatory Overview of 2,4

- D and Glufosinate Used on DAS

- 68416

- 4 Soybean 1.2.2 Registration Review The Food Quality Protection Act (FQPA) 3 o f 1996 amended FIFRA to mandate a program called registration review

. 4 The registration review program makes sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory sta ndard of no unreasonable adverse effects. Through the registration review program, the EPA periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can still be used safely. 1.2.3 FIFRA Enforcement It is a violation of FIFRA for any person to use a pesticide in a manner inconsistent with its labeling. 5 EPA may issue a civil administrative complaint to any person or company who violates FIFRA. The complaint may impose a civil penalty, including recovery of any economic benefit of non

compliance, and may also require correction of the violation. EPA may also issue a Stop Sale, Use or Removal Order (SSURO) prohibiting the person who owns, controls, or has custody of a violative pesticide or device from selling, using, or r emoving that product except in accordance with the provisions of the SSURO. 6 1.2.4 FFDCA Where pesticides may be used on food or feed crops, EPA also sets tolerances for the amount of pesticide chemical residue that can legally remain in or on foods. EPA underta kes this analysis under the authority of the Federal Food, Drug, and Cosmetic Act (FFDCA). Under FFDCA, EPA must find that such tolerances will be safe, meaning that there is a reasonable certainty that no harm will result from the aggregate exposure of th e pesticide chemical residue. This finding must be made and the appropriate tolerance established before a pesticide can be registered for use on the particular food or feed crop in question, including DAS

- 68416

- 4 soybean. Taken together, the provisions of FIFRA and FFDCA vest EPA with comprehensive responsibility and authority for the regulation of 2,4

- D and glufosinate and for addressing the cumulative health, safety and environmental effects of 2,4

- D and glufosinate use in the United States. 1.2.5 Pesticide R isk Assessment at EPA 7 1.2.5.1 Human Health and Ecological Pesticide Risk Assessment at EPA The process EPA uses for evaluating the potential health and environmental effects of 2,4

- D, glufosinate , and every other registered pesticide, under either FIFRA or FFDCA, is called risk assessment.

3 http://www.epa.gov/pesticides/regulating/laws/fqpa/ 4 http://www.epa.gov/oppsrrd1/registration_review/ 5 7 U.S.C. § 136j(a)(2)(G). 6 http://www.epa.gov/compliance/civil/fifra/fifraenfstatreq.html ; 7 U.S.C. §§ 136j, 136k, 136l. 7 http://www.epa.gov/pesticides/about/overview_risk_assess.htmSupplemental Information for USDA Petition for Nonregulated Status of DAS

- 68416

- 4Soybean Page 6 of 13

Regulatory Overview of 2,4

- D and Glufosinate Used on DAS

- 68416

- 4 Soybean For human health, the assessment includes a review of data that address potential exposure through consumption of food and drinking water, as well as occupati onal and bystander exposure that might result from pesticide use. 8 For its environmental risk assessment, EPA evaluates the potential effects of pesticide use on: soil, surface water, groundwater, wildlife, and other non

- target organisms such as birds, a mphibians, mammals, soil microorganisms and beneficial insects, including bees. This review covers plants as well as animals, and includes consideration of threatened and endangered species. Detailed information on the EPA ecological risk assessment proces s is available on the EPA website. 9

1.2.5.2 Cumulative and Aggregate Human Health Risk Assessments under FQPA FQPA requires EPA to consider available information concerning the cumulative effects of a particular pesticide’s residue and other substances that have a common mechanism of toxicity when considering whether to establish, modify, or revoke a pesticide tolerance. Potential cumulative effects of chemicals with a common mechanism of toxicity are considered because low

- level exposures to multiple chemicals cau sing a common toxic effect by a common mechanism could lead to the same adverse effect as would a higher level of exposure to any one of the individual chemicals. This assessment is termed a “Cumulative Assessment” by EPA; more detailed information is avai lable on the EPA website. 10 FQPA also requires EPA to consider aggregate exposure in its decision making. Aggregate exposure and risk assessment involve the analysis of exposure to a single chemical by multiple pathways and routes of exposure. The pathways of exposure considered are generally pesticide residues in food and drinking water, but also include non

- occupational (e.g., residential) routes of exposure. EPA uses the aggregate and cumulative risk assessment processes to ensure that all registered ( approved) uses of a specific pesticide fit within the “risk cup” for that pesticide. When EPA receives an application to amend an existing registration for a pesticidal active ingredient to include a new use pattern, EPA evaluates the impact of that propo sed new use pattern on the aggregate and cumulative risk of that active ingredient, i.e., on the risk cup. A new use pattern cannot be approved if it would cause the risk cup to be exceeded. 1.3 Endangered Species Act The Endangered Species Act (ESA) is intended to protect and promote the recovery of animals and plants that are in danger of becoming extinct. All federal agencies are required under the ESA to ensure that their regulatory actions, including EPA’s registra tion of pesticides in the United States, are not likely to jeopardize the continued existence of threatened or endangered species (listed species) or destroy or adversely modify their critical habitat. The ESA also prohibits both federal and non

- federal en tities from injuring or killing individual listed animals

8 http://www.epa.gov/pesticides/factsheets/riskassess.htm 9 http://www.epa.gov/pesticides/ecosystem/ecorisk.htm 10 http://www.epa.gov/pesticides/cumulative/Supplemental Information for USDA Petition for Nonregulated Status of DAS

- 68416

- 4Soybean Page 7 of 13

Regulatory Overview of 2,4

- D and Glufosinate Used on DAS

- 68416

- 4 Soybean without authorization. The ESA is administered by the U.S. Fish and Wildlife Service and National Marine Fisheries Service (NMFS) (together referred to as the Services). Detailed information on the processes followed by EPA to comply with the ESA is provided on the EPA website 11 and summarized below. 1.3.1 EPA Responsibilities When registering a pesticide or reassessing the potential ecological risks from use of a currently registered pesticide, EPA evaluat es extensive toxicity and ecological effects data to determine how a pesticide will move through and break down in the environment. Risks to birds, fish, invertebrates, mammals and plants are routinely assessed and used in EPA’s determinations of whether a pesticide may be registered for use in the United States. EPA’s core pesticide risk assessment and regulatory processes ensure that protections are in place for all populations of non

- target species. Because endangered species may need specific protectio n, EPA has developed risk assessment procedures to determine whether individuals of a listed species have the potential to be harmed by a pesticide, and if so, what specific protections may be appropriate. EPA’s conclusion regarding the potential risks a p esticide may pose to a listed species and any designated critical habitat for the species, after conducting a thorough ecological risk assessment, results in an "effects determination." The Services have recognized the appropriateness of these procedures in their regulations implementing the ESA. 12 1.3.2 Effects Determinations The result of an assessment to determine potential effects of a pesticide’s registration to a listed species will result in one of two determinations:
 the pesticide’s registered use will have "no effect" on the species; or
 the pesticide’s registered use "may affect" the species. If EPA determines the pesticide "may affect" the species, it refines its assessment to determine whether the pesticide’s use:
 "may affect, but is not likely to adversely affect" the species; or
 "may affect and is likely to adversely affect" the species. A determination that the pesticide "may affect, but is not likely to adversely affect," is made where the effects on the list ed species are expected to be discountable, or insignificant, or completely beneficial; terms which the Services have discussed in guidance as including effects extremely unlikely to occur, which cannot be evaluated, would never reach a scale where they wo uld occur or are wholly beneficial. 1.3.3 Consultation with the Service Informal Consultation

- If EPA determines that a pesticide will have "no effect" on a listed species, no further action is required relative to the pesticide’s registration, label or use

11 http://www.epa.gov/oppfead1/endanger/ 12 50 CFR Part 402, Subpart D.Supplemental Information for USDA Petition for Nonregulated Status of DAS

- 68416

- 4Soybean Page 8 of 13

Regulatory Overview of 2,4

- D and Glufosinate Used on DAS

- 68416

- 4 Soybean in structions. If EPA determines that a pesticide’s use "may affect, but is not likely to adversely affect" a listed species, the Agency may engage the Services in a process called informal consultation. The result of this process is typically a letter of con currence or non - concurrence from the Services, with EPA’s determination. Formal Consultation

- If the Services non

- concur with EPA’s determination that a pesticide’s registered use is "not likely to adversely affect" a species or if EPA determines that t he pesticide "may affect and is likely to adversely affect" a listed species, it will engage the Services in a process called formal consultation. The Services’ regulations allow EPA to avail itself of either of two alternative procedures for formal cons ultation. Under the procedure available to all agencies (under 50 CFR Part 402, Subpart B), EPA provides the Services with its detailed assessment of potential risks and its effects determination. The Services review that information and consider it in li ght of the status and needs of the particular species potentially affected. The Services then generally provide EPA with a Biological Opinion, a document providing the Services' assessment and recommendations for steps that EPA should take, if any, to redu ce or eliminate potential risk to the species. The Services’ Biological Opinion provides the Services’ view of whether the pesticide’s registered use is likely to jeopardize the continued existence of the species and, if so, describes alternatives to avo id jeopardy. The Services also authorize any "take" (unintended injury or killing of individual listed animals) that would otherwise be prohibited, as long as measures to minimize take are implemented. Alternatively, EPA may invoke all or part of the “optional formal consultation procedure for FIFRA actions” (set forth in 50 CFR § 402.46). Under this procedure, as under the standard procedure described above, EPA provides the Service with an effects determination. In this case, however, EPA also may include in that determination conclusions and other elements that typically would be included in the Services’ Biological Opinion, such as whether the action is likely to jeopardize the continued existence of a species and available alternatives. The Ser vices then has a limited period to either adopt EPA’s conclusions or provide its alternative views in a separate Biological Opinion. 1.3.4 Implementing Measures to Protect Listed Species If, as a result of EPA’s risk assessment or formal consultation with th e Services, EPA determines that a pesticide’s registration, label, or use instructions should be altered to ensure that use of a pesticide will not take or jeopardize the continued existence of a listed species, EPA may require changes to the use condition s specified on the label of the product. When such changes are necessary only in specific geographic areas rather than nationwide to ensure protection of the listed species, EPA implements these changes through geographically

- specific Endangered Species Pr otection Bulletins. 1.4 Non

- Federal Regulatory Oversight of Pesticides After a pesticide is registered by EPA, it must be registered in individual states and territories under specific pesticide registration laws before it can be sold and used. A state or terr itory maySupplemental Information for USDA Petition for Nonregulated Status of DAS

- 68416

- 4Soybean Page 9 of 13

Regulatory Overview of 2,4

- D and Glufosinate Used on DAS

- 68416

- 4 Soybean have more stringent requirements for registering pesticides for use in that state, and the allowable use patterns of a pesticide can vary from state to state. Detailed information on state pesticide regulatory agencies is available from the Nat ional Pesticide Information Center

. 13 2 Regulatory Status of 2,4 - D and Glufosinate at EPA 2.1 2,4

- D 2,4

- D has been registered for use in the United States since 1948

. 14 EPA concluded its reregistration evaluation of 2,4

- D in 2005. At that time, the Agency produced a 304

- page Reregistration Eligibility Document (“RED”) on 2,4

- D, setting out the data on which it made a decision to reregister 2,4

- D, and concluded that t he pesticide met the no unreasonable adverse effects st andard found in FIFRA. Detailed information on the reregistration of 2,4

- D at the EPA is available on the EPA website

. 15 As a currently registered pesticide, 2,4

- D is included in the EPA Registration Review program

. 16 The Registration Review for 2,4

- D is s cheduled to be opened in fiscal year 2013

. 17 EPA can require registrants to modify proposed label language contained in registration applications, including use patterns, to ensure food safety and that the use of the pesticide will not cause unreasonable adverse effects on the environment. It is possible that EPA could approve, conditionally approve, or reject an application for the registered use of 2,4

- D on DAS

- 68416

- 4 soybean . EPA could also register the use of 2,4

- D on DAS

- 68416

- 4 soybean , but in the f uture amend or cancel that registration. 2.2 Glufosinate Glufosinate was first registered as a pesticide in 2000 , 18 and thus was not required to undergo reregistration. As a currently registered pesticide, however, glufosinate is included in the EPA Registration Review program

. 19 The Registration Review for glufosinate was initiated in 200 8 and a final decision is scheduled for 2013

. 20 , 21 Glufosinate is currently registered by EPA for use on soybeans. It is possible that in the future EPA could amend or cancel that registration.

13 http://npic.orst.edu/state1.htm 14 http://www.epa.gov/oppsrrd1/REDs/factsheets/24d_fs.htm 15 http://www.epa.gov/opp00 001/reregistration/24d/ 16 http://www.epa.gov/oppsrrd1/registration_review/ 17 http://www.epa.gov/oppsrr d1/registration_review/2010

- 13

- schedule

- summary.pdf 18 Glufosinate Summary Document Registration Review: Initial Docket March 2008, US EPA, EPA

- HQ

- OPP

- 2008

- 0190

- 0003

. 19 http://www.epa.gov/oppsrrd1/registration_review/ 20 http://www.epa.gov/oppsrrd1/registration_review/glufosinate_ammonium/index.htm 21 Glufosinate Final Work Plan, Registration Review, August 2008, US EPA, EPA

- HQ

- OPP

- 20 08

- 0190

- 0015

.Supplemental Information for USDA Petition for Nonregulated Status of DAS

- 68416

- 4Soybean Page 10 of 13

Regulatory Overview of 2,4

- D and Glufosinate Used on DAS

- 68416

- 4 Soybean 2.3 Legal Challenges to EPA Decisions The U.S. government provides mechanisms for individuals or groups to challenge decisions made by EPA. Individuals or groups can petition the EPA for specific actions related to pesticide registration decisions made by EPA, and this has occurred for 2,4

- D. On November 6, 2008, the Natural Resources Defense Council (NRDC) submitted a petition to EPA to revoke all pesticide tolerances and cancel all registrations for 2,4

- D based on allegations of human health risks, including estrogenic, neurodevelopmental and mutagenic effects. EPA opened a public docket that contains this petition from NRDC and over 500 public comments that were received. 22 DAS and other 2,4

- D registrant s, through the Industry Task Force II on 2,4

- D Research Data (2,4

- D Taskforce), provided comments to EPA regarding this petition. 23 The 2,4

- D Taskforce comments stated that the studies on which the NRDC based its petition were either not relevant to human or environmental routes of exposure, or were run at excessively high doses that bear no relationship to possible levels of human or environmental exposure, and refuted the claims made in the petition. The 2,4

- D Taskforce based its reasoning on over 500 st udies, all conducted according to Good Laboratory Practices and many published in peer reviewed scientific journals, that were used to support EPA’s RED. On May 19, 2009, NRDC wrote to EPA, asking the agency to first address the residential uses of 2,4

- D, “as these are the ones that we believe cause the greatest health risks.” 24 EPA has not yet responded to NRDC’s petition, and the outcome of EPA’s review of the petition to cancel all tolerances and registrations of 2,4

- D cannot be reasonably foreseen. EP A’s registration of a pesticide for specific uses can also be challenged through litigation; see for example Washington Toxics Coalition v. EPA

. 25 In that case, a coalition of environmental groups filed a lawsuit against EPA for violating the ESA by failin g to consult with NMFS regarding the impacts of certain pesticides, including 2,4

- D, to endangered or threatened salmonid species in the Pacific Northwest. The court placed restrictions on the use of those pesticides in or near the habitat of the species at issue pending completion of the consultation process. EPA has determined that the use of 2,4

- D in the formulation used for crops such as corn may affect, but is not likely to adversely affect, the endangered salmonid species 26 , but the consultation with NMFS has not yet taken place. EPA currently expects that consultation will be completed and that NMFS will issue a Biological Opinion for 2,4

- D in June 2011. 27 2,4

- D is included, along with other pesticides, in a lawsuit brought in early 2011 by the Cente r for Biological Diversity against EPA alleging potential harm to threatened and endangered species arising from the use of these pesticides. It is possible this litigation could result in any number of actions to be taken by EPA, such as restrictions on the use of any of the pesticides named in the lawsuit, that could impact uses of 2,4

- D on DAS

- 68416

- 4 soybean.

22 http://www.regulations.gov/search/Regs/home.html#docketDetail?R=EPA

- HQ

- OPP

- 2008

- 0877 23 http://24d.org/ ; comments available at http://24d.org/pdf/EPA

- HQ

- OPP

- 2008

- 0877

- 0350%201.pdf 24 http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPP

- 2008

- 0877

- 0445.1 25 http://www.epa.gov/espp/litstatus/wtc/index.htm 26 http://www.epa.gov/espp/litstatus/effects/index.htm 27 http://www.epa.gov/espp/litstatus/effects/biopschedule01

- 20

- 11.pdfSupplemental Information for USDA Petition for Nonregulated Status of DAS

- 68416

- 4Soybean Page 11 of 13

Regulatory Overview of 2,4

- D and Glufosinate Used on DAS

- 68416

- 4 Soybean The probability and potential outcome of any current or future legal challenge to the use of 2,4

- D or glufosinate in general or on DAS

- 68416

- 4 soybean in particular cannot be reasonably foreseen. 3 Existing and Proposed Use Patterns 3.1 2,4

- D 2,4

- D is a herbicide registered by EPA for the control of broadleaf weeds, and is currently approved for preplant use on soybean s. For soybeans , EPA has approved a maximum seasonal application rate at 1 .0 lb/acre, and a maximum single application rate at 1. 0 lb/acre. EPA approved these application rates based on the safety standards established under both FIFRA and FFDCA. Table 1 . Summary of Current Use Pattern for 2,4 - D on Soybeans . Crop Stage Maximum

Application Rate (lb/acre) a Directions and Timing Preplant 1.0 Apply not less than 15

- 30 days before planting soybeans, when weeds are small and actively growing

. a All values in acid equivalents. DAS submitted an application to EPA to register the use of a new end

- use formulation of 2,4

- D on DAS

- 68416

- 4 soybean in April 201 1

. The proposed use pattern on DAS

- 68416

- 4 soybean allows a 1 lb ae/acre burn

- down applicat ion followed by up to two 0.5

- 1.0 lb ae/acre post

- emergent applications through the R2 growth stage. The proposed use pattern for 2,4

- D on DAS

- 68416

- 4 soybean allows for flexibility in early season weed control when control of weeds is critical to minimize crop competition and maximize yield potential. Table 2 . Proposed Use Pattern for 2,4 - D on DAS - 68416 - 4 Soybean . Crop Stage Maximum

Application Rate (lb/acre) a Directions and Timing Preplant or Preemergence 1.0 Apply before soybean emerges to control emerged broadleaf weed seedlings or existing cover crops. Postemergence 1.0 Apply after crop and weed emergence but before soybean exceeds growth stage R2

. Make 1 to 2 applications with a minimum of 1 2 days between applications. a All values in acid equivalents. DAS

- 68416

- 4 soybean will be combined through conventional breeding (i.e., “stacked”) with commercially available glyphosate

- tolerance traits in soybean . The combination of 2,4

- D, glufosinate , and glyphosate

- tolerance will provide a superior weed control system thatSupplemental Information for USDA Petition for Nonregulated Status of DAS

- 68416

- 4Soybean Page 12 of 13

Regulatory Overview of 2,4

- D and Glufosinate Used on DAS

- 68416

- 4 Soybean effectively controls many hard

- to

- control weeds and weeds that have developed resistance to glyphosate under glyphosate

- only cultural practices. 3.2 Glufosinate Glufosinate is a non

- sel ective foliar herbicide that is used for preplant and post

- emergent control of broadleaf weeds. Glufosinate

- ammonium acts by inhibiting glutamine synthetase, which leads to the overproduction of ammonia causing necrosis and death of the plant . It is regist ered for use on the following crops: apples, berries, canola, corn, cotton, currants, grapes, grass grown for seed, potatoes, rice, soybeans, sugar beets, and tree nuts. Registrations for non

- crop areas include golf course turf, residential lawns, ornament als, and a variety of industrial, residential, and public areas. Application rates vary considerably by use pattern, with the highest rate (1.5 lb ai/A) for use patterns including orchard nuts and fruits, grapes, grasses grown for seed, and golf course tu rf. Multiple applications are allowed by most labels, with an annual maximum application rate of 4.5 lbs ai/A for orchards and vineyards. 18 DAS do es not currently plan to make any regulatory submissions to US EPA relating to the use of glufosinate on DAS

- 68416

- 4 soybeans. 4 Environmental Risk Assessment 4.1 2,4

- D The proposed use pattern for 2,4

- D on DAS

- 68416

- 4 is similar to that currently registered by EPA for use on corn . The evaluation of this use pattern of 2,4

- D on corn provides an understanding of the process that EPA may use to evaluate the proposed use pattern for 2,4

- D on DAS

- 68416

- 4 soybean. In the environmental risk assessment conducted for the 2005 RED for 2,4

- D, EPA considered 16 environmental exposure scenarios to represent the greater than 600 different use patterns for 2,4

- D. The agency chose scenarios with one or more of the following properties in order to adequately represent all of t he use patterns:
 C rops with higher than average application rates

.  C rops which have a large percentage of their total acreage treated with 2,4

- D

.  C rops with a large total acreage treated with 2,4

- D. By encompassing crops with large percentages of acreage treated with 2,4

- D and a large geographic area, some crops with lower maximum application rates were , therefore , also covered by this set of scenarios. The specific scenarios chosen included sugarcane in Florida, turf in Florida and Pennsylvania, spring w heat in North Dakota, winter wheat in Oregon, corn in Illinois and California, sorghum in Kansas and Texas, soybean in Mississippi, pasture in North Carolina, apples in North Carolina, Oregon, and Pennsylvania, filberts in Oregon, and citrus in California.Supplemental Information for USDA Petition for Nonregulated Status of DAS

- 68416

- 4Soybean Page 13 of 13

Regulatory Overview of 2,4

- D and Glufosinate Used on DAS

- 68416

- 4 Soybean The use pattern considered by EPA for corn was 3 individual applications of 1.0 lb ae/A. The use pattern proposed by DAS for use on DAS

- 40278

- 9 corn has equivalent individual and seasonal maximum use. As DAS

- 40278

- 9 corn is expected to replace, not add to, current corn acreage where corn is currently cultivated, and is not expected to be grown in any areas where corn is not currently cultivated, EPA’s exposure and risk assessment would also encompass the use of 2,4

- D on DAS

- 40278

- 9 corn. Individual appl ications of 2.0 lb ae/A were modeled for sugarcane in Florida, turf in Florida and Pennsylvania, pasture in North Carolina, and apples in North Carolina, Oregon, and Pennsylvania. Seasonal applications of 4.0 lb ae/A were modeled for sugarcane in Florida, turf in Florida and Pennsylvania, pasture in North Carolina, apples in North Carolina, Oregon, and Pennsylvania, and filberts in Oregon. These RED scenarios developed by EPA for purposes of 2,4

- D’s environmental risk assessment exceed the maximum individua l and seasonal application rates proposed for 2,4

- D on DAS

- 40278

- 9 corn. Detailed information on these assessments from EPA is available in
 Revised Environmental Fate and Effects Division Revised Preliminary Risk Assessment for the 2,4

- Dichlorophenoxyace tic acid (2,4

- D) Reregistration Eligibility Document o Summary (EPA

- HQ

- OPP

- 2004

- 0167

- 0091) 28 o Complete Risk Assessment (EPA

- HQ

- OPP

- 2004

- 0167

- 0092) 29 4.2 Glufosinate Glufosinate is currently registered by EPA for use on soybeans. DAS does not currently plan to make any regulatory submissions to US EPA relating to the use of glufosinate on DAS

- 68416

- 4 soybeans.

28 http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPP

- 2004

- 0167

- 0091 29 http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPP

- 2004

- 0167

- 0092