Record of Decision 

In this Record of Decision (ROD), APHIS is announcing the agency's environmental decision on 

the alternatives examined in the FEIS. In accordance with its statutory authority and following 

the publication of its FEIS, APHIS is choosing Alternative 2. APHIS' regulatory Determinations 

ofnonregulated status ofDAS-40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 soybean 

will become effective upon publication in the Federal Register. The three Determinations are 

entitled: 

• Determination ofNonregulated Status for Dow AgroSciences'DAS-40278-9 Com; 

• Determination ofNonregulated Status for Dow AgroSciences' DAS-68416-4 Soybean; 

and 

• Determination ofNonregulated Status for Dow AgroSciences' DAS-44406-6 Soybean. 

BACKGROUND 

Coordinated Framework 

APHIS is one of the Federal agencies with regulatory responsibilities under the 1986 Federal 

Coordinated Framework for the Regulation of Biotechnology (hereafter Coordinated 

Framework) published by the Office of Science and Technology Policy, Executive Office of the 

President. The Coordinated Framework is a policy statement which "describes the 

comprehensive Federal regulatory policy for ensuring the safety of biotechnology research and 

products." The Coordinated Framework explains the proper allocation and coordination of 

oversight responsibilities under the relevant statutes and among the relevant Federal agencies. 

The Coordinated Framework thus addresses who shall have oversight authority in each instance, 

but does not address how that authority should be exercised in the frequent situations in which a 

statute leaves the implementing agency latitude for discretion. To that end, the Office of Science 

and Technology Policy published a notice of Federal policy in the Federal Register in 1992 in 

which it set forth "the proper basis for agencies' exercise of oversight authority within the scope 

of discretion afforded by statute." 

The notice describes: 

"a risk-based, scientifically sound approach to the oversight of planned introductions of 

biotechnology products into the environment that focuses on the characteristics of the 

biotechnology product and the environment into which it is being introduced, not the 

process by which the product is created. Exercise of oversight in the scope of discretion 

afforded by statute should be based on the risk posed by the introduction and should not 

tum on the fact that an organism has been modified by a particular process or technique." 

The policy statement of 1992 states further: 

Page2 

"In order to ensure that limited federal oversight resources are applied where they will 

accomplish the greatest net beneficial protection of public health and the environment, 

oversight will be exercised only where the risk posed by the introduction is unreasonable, 

that is, when the value of the reduction in risk obtained by additional oversight is greater 

than the cost thereby imposed. The extent and type of oversight measure(s) will thus be 

commensurate with the gravity and type of risk being addressed, the costs of alternative 

oversight options, and the effect of additional oversight on existing safety incentives." 
Record of Decision 

Dow AgroSciences Petitions (09-233-0lp, 09-349-0lp, and 11-234-0lp) for Determination of 

Nonregulated Status for 2,4-D-Resistant Corn and Soybean Varieties 

OVERVIEW 

The United States Department of Agriculture (USDA) Animal and Plant Health Inspection 

Service (APHIS) completed and published a Final Environmental Impact Statement (FEIS) after 

receiving three petitions submitted by Dow AgroSciences LLC, oflndianapolis, Indiana (Dow), 

seeking determinations of nonregulated status for com and soybean cultivars genetically 

engineered to be resistant to herbicides. The first petition, APHIS Petition Number 09-233-01p, 

seeks a determination ofnonregulated status for com (Zea mays) designated as event DAS40278-9. This event has been genetically engineered for increased resistance to certain broadleaf 

herbicides in the phenoxy auxin group (particularly the herbicide 2,4-D) and resistance to grass 

herbicides in the aryloxyphenoxypropionate (AOPP) acetyl coenzyme A carboxylase (ACCase) 

inhibitor group (i.e., "fop" herbicides, such as quizalofop-p-ethyl). The second petition, APHIS 

Petition Number 09-349-01p, seeks a determination ofnonregulated status for soybean (Glycine 

max) designated as DAS-68416-4. This soybean event has been genetically engineered for 

resistance to certain broadleaf herbicides in the phenoxy auxin growth regulator group 

(particularly the herbicide 2,4-D) and the nonselective herbicide glufosinate. The third petition, 

APHIS Petition Number 11-234-0lp, seeks a determination ofnonregulated status for soybean 

designated as event DAS-44406-6, which has been genetically engineered for resistance to 

certain broadleafherbicides in the auxin growth regulator group (particularly the herbicide 2,4-

D) and the nonselective herbicides glyphosate and glufosinate. 

The petitions state that these articles are unlikely to pose a plant pest risk and, therefore, should 

not be regulated articles under APHIS' regulations in 7 Code of Federal Regulations (CFR) part 

340. These part 340 regulations are authorized by the Plant Protection Act to prevent the 

introduction or dissemination of plant pests, and the decision on whether or not to approve the 

petitions is based on this authority. 

APHIS prepared the FEIS to examine the potential environmental impacts ofDAS-40278-9 com, 

DAS-68416-4 soybean, and DAS-44406-6 soybean (also known as EnlistTM com and soybean) 

and the potential interrelated socioeconomic impacts associated with determinations of 

nonregulated status ofthese genetically engineered (GE) com and soybean events. APHIS 

examined four alternatives in the FEIS: 

• Alternative 1: No Action; 

• Alternative 2: Determination ofNonregulated Status ofDAS-40278-9 Com, DAS68416-4 Soybean, and DAS-44406-6 Soybean; 

• Alternative 3: Determination ofNonregulated Status ofDAS-40278-9 Com, Only; and 

• Alternative 4: Determination ofNonregulated Status ofDAS-68416-4 Soybean and 

DAS-44406-6 Soybean, Only. 
Record of Decision 

The Coordinated Framework explains the regulatory roles and authorities for the three major 

agencies involved in regulating GE organisms: USDA APHIS, the Environmental Protection 

Agency (EPA), and the Food and Drug Administration (FDA). 

EPA Regulation of Biotechnology 

The EPA is responsible for regulating the sale, distribution, and use of pesticides, including those 

that are expressed by an organism modified using techniques of modem biotechnology, 

identified as plant-incorporated protectants 1

• The EPA regulates these plant-incorporated 

protectants (PIPs) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 

U.S.C. 136, et seq.) and certain biological control organisms under the Toxic Substances Control 

Act (TSCA) (15 U.S.C. 53, et seq.). Before planting a crop containing a PIP, a company must 

seek an experimental use permit from EPA. Commercial production of crops containing PIPs for 

purposes of seed increases and sale requires a FIFRA Section 3 Registration with EPA. Before 

EPA can register a pesticide there must be sufficient data demonstrating that it will not pose 

unreasonable risks to human health or the environment when used according to label directions. 

When assessing the potential risks of genetically engineered PIPs, EPA requires extensive 

studies examining numerous factors, such as risks to human health, nontarget organisms and the 

environment, potential for gene flow, and the need for insect resistance management plans. 

FDA Regulation of Biotechnology 

The FDA regulates GE organisms under the authority of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 301 et seq.). The FDA published its policy statement concerning regulation of products 

derived from new plant varieties, including those derived from genetic engineering, on May 29, 1992 

(57 FR 22984). Under this policy, the FDA implements a voluntary consultation process to ensure 

that human food and animal feed safety issues or other regulatory issues, such as labeling, are 

resolved before commercial distribution of food derived from GE products2

. 

APHIS Regulation of Biotechnology 

In 1987, APHIS promulgated its biotechnology regulations (7 CFR part 340) under the authority 

ofthe Federal Plant Pest Act (FPPA) and the Plant Quarantine Act (PQA)3 to address potential 

1 A list of EPA Current and Previously Registered Section 3 PIP Registrations can be found here: 

http://www .epa. gov/pesticides/biopesticides/pips/pip _list.htm. 

2 A list of all completed Biotechnology consultations on Genetically Engineered foods evaluated under FDA's 1992 

Statement of Policy: Foods Derived from New Plant Varieties can be found here: 

http://www.accessdata.fda.gov/scripts/fdcc/?set=Biocon. 

3 The FPPA and PQA were consolidated along with other statutory authorities into the Plant Protection Act of 2000, 

in which Congress found that: "it is the responsibility of the Secretary to facilitate exports, imports, and interstate 

commerce in agricultural products and other commodities that pose a risk of harboring plant pests ... in ways that 

will reduce, to the extent practicable, as determined by the Secretary, the risk of dissemination of plant pests ... ; 

decisions affecting imports, exports, and interstate movement of products regulated under this title shall be based on 

sound science .... " 

The Plant Protection Act of 2000 defmes a plant pest as: 

PLANT PEST-The term ''plant pest'' means any living stage of any of the following that can directly or 

indirectly injure, cause damage to, or cause disease in any plant or plant product: 

(A) A protozoan. 

(B) A nonhuman animal. 

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Record of Decision 

risks that certain GE organisms might pose as plant pests. The regulations refer to such GE 

organisms as "regulated articles. 4

" 

The APHIS regulations codified at 7 CFR part 340 were amended in 1993 to provide a procedure 

for the deregulation (i.e., a petition for nonregulated status) of such GE plants which are unlikely 

to present a plant pest risk and, therefore, should no longer be regulated. 7 CFR 340.6 describes 

the process for submitting petitions for nonregulated status, the data requirements, and actions 

that the APHIS Administrator may take on the petition. It is under this procedure that APHIS 

received petition requests from Dow seeking determinations ofnonregulated status ofDAS40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 soybean. Petition 09-233-01p for 

DAS-40278-9 com was received on August 19, 2009; Petition 09-349-01p for DAS-68416-4 

soybean was received on December 8, 2009; and Petition 11-234-01p for DAS-44406-6 soybean 

was received on August 18, 2011. 

In response to the receipt of the three Dow petitions, APHIS prepared plant pest risk assessments 

(PPRAs) to assess the plant pest risk for each plant variety pursuant to the Plant Protection Act. 

APHIS also examined the environmental impacts of its potential regulatory decisions for 

nonregulated status of EnlistTM com and soybean pursuant to the National Environmental Policy 

Act(NEPA). 

Federal Register notices sought public comments on two petitions, 09-233-01p (DAS-40278-9 

com) and 09-349-01p (DAS-68416-4 soybean), as well as a draft PPRA and a draft 

Environmental Assessment (EA) for each of these two petitions. An EA was not prepared for the 

third petition, 11-234-01 p (DAS-44406-6 soybean), so that notice only sought comments for the 

petition. After APHIS initiated its NEP A process by preparing the two EAs, APHIS carne to the 

decision that it was appropriate to use one NEP A document to evaluate the three similar Enlist 

events. Accordingly, APHIS decided to prepare an environmental impact statement (EIS) to 

analyze and examine the potential environmental impacts of all three of the Enlist petitions. 

On January 10, 2014, APHIS published a Federal Register notice of availability for the draft 

PPRAs and the draft environmental impact statement (DEIS) for the petitions for determination 

ofnonregulated status for Enlist com and soybean for public review and comment (79 FR 1861). 

(C) A parasitic plant. 

(D) A bacterium. 

(E) A fungus. 

(F) A virus or viroid. 

(G) An infectious agent or other pathogen. 

(H) Any article similar to or allied with any of the articles specified in the preceding subparagraphs. 

(7 U.S.C. §7702(14) 

4 A "regulated article" is defmed as: "Any organism which has been altered or produced through genetic 

engineering, if the donor organism, recipient organism, or vector or vector agent belongs to any genera or taxa 

designated in§ 340.2 and meets the defmition of plant pest, or is an unclassified organism and/or an organism 

whose classification is unknown, or any product which contains such an organism, or any other organism or product 

altered or produced through genetic engineering which the Administrator, determines is a plant pest or has reason to 

believe is a plant pest. Excluded are recipient microorganisms which are not plant pests and which have resulted 

from the addition of genetic material from a donor organism where the material is well characterized and contains 

only non-coding regulatory regions." (7 CFR 340.0) 

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Record of Decision 

The PPRAs and DEIS were available for public comment for a 60-day comment period which 

closed on March 11, 2014. APHIS received 10,147 submissions to the docket (APHIS-2013-

0042). Ofthese comments, 8,940 opposed and 1,082 supported the approval ofnonregulated 

status of the three Enlist varieties. The remaining 125 comments were submissions of 

attachments, requests for extensions, or were submissions to an incorrect docket. Some of the 

submissions in support or opposition were petitions with signatures, letters with multiple 

signatures, or batches of nearly identical letters. In addition, APHIS conducted a virtual public 

meeting on January 29, 2014, at which a total of24 participants provided comments (9 opposed 

to and 15 in favor of deregulation). 

APHIS reviewed and evaluated all of the public comments received on the DEIS for the three 

Enlist petitions and prepared formal responses to them as part ofthe PEIS. On August 8, 2014, a 

Notice in the Federal Register announced the availability of the PEIS to the public. Additionally, 

APHIS distributed the PEIS to all interested individuals who had specifically requested a copy of 

the PEIS and also posted it on its website5

• 

PURPOSE AND NEED FOR AGENCY ACTION 

In the PEIS, APHIS identified a purpose and need to respond to the Enlist petitions for 

determinations of nonregulated status for the three GE events in accordance with its current 

regulatory authority. As required by 7 CPR 340.6, APHIS must respond to petitioners that 

request a determination of the regulated status of GE organisms, including GE plants such as 

Enlist com and soybean, and must make a determination on whether the GE organism is likely to 

pose a plant pest risk. If APHIS determines, based on its PPRA, that the GE organism is unlikely 

to pose a plant pest risk, APHIS has no legal basis to continue to regulate that GE organism and 

must deregulate the GE organism. Once APHIS does deregulate aGE organism, the GE 

organism is no longer subject to the plant pest provisions of the Plant Protection Act of 2000 and 

7 CPR part 340. In summary, the purpose and need of this project is to make a decision on these 

petitions that is consistent with its regulatory requirements in 7 CPR part 340. 

PLANT PEST RISK ASSESSMENT 

The PPRA characterizes the potential plant pest risks associated with the GE product (crop) that 

is the subject of the petition for nonregulated status relative to its conventional varieties. It is 

based on information supplied in the petition for determination of nonregulated status together 

with other relevant publically available scientific data. 

APHIS concluded from its PPRAs that DAS-40278-9 com, DAS-68416-4 soybean, and DAS44406-6 soybean are unlikely to pose a plant pest risk. APHIS found no evidence of Enlist com 

and soybean posing plant pest risks or other risks based on the following reasons: 

(1) No plant pest risk was identified from the transformed process, the insertion and/or 

expression of new genetic material, or from changes in metabolism in DAS-40278-9 com, DAS68416-4 soybean, and DAS-44406-6 soybean. 

5 The FEIS can be viewed at http://www.aphis.usda.gov/brs/aphisdocs/24d_feis.pdf or under docket number APHIS2013-0042 at regulations.gov. 

Page 5 
Record of Decision 

(2) Disease and pest incidence and/or damage were not observed to be significantly increased or 

atypical in Enlist com and soybean and derived hybrids compared to their nontransgenic control 

counterparts or other comparators in field trials conducted in growing regions representative of 

where DAS-40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 soybean are expected to be 

grown. Observed agronomic traits also did not reveal any significant differences that would 

indirectly indicate that DAS-40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 soybean 

are more susceptible to pests or diseases. Therefore, no plant pest effects are expected based on 

these or other agricultural products. 

(3) Based on an evaluation ofthe gene products (AAD-1 protein in DAS-40278-9 com; AAD-12 

and PAT proteins in DAS-68416-4 soybean; AAD-12, PAT, and 2mEPSPS in DAS-44406-6 

soybean) and agronomic and compositional data, exposure to and/or consumption of Enlist com 

and soybean are unlikely to adversely impact nontarget organisms beneficial to agriculture. 

(4) DAS-40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 soybean are no more likely to 

become weedier or more difficult to control as a weed than conventional varieties ofthese crops 

based on their observed agronomic characteristics, the weediness potential of the crops and 

current agronomic management practices that would be available to control DAS-40278-9 com, 

DAS-68416-4 soybean, and DAS-44406-6 soybean as a weed. 

(5) DAS-40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 soybean are not likely to 

increase the weed risk potential of other species with which they can interbreed in the United 

States or its territories. Gene flow, hybridization and/or introgression of inserted genes from 

Enlist com and soybean to other sexually compatible relatives with which they can interbreed is 

not likely to occur. 

( 6) Major changes in agricultural or cultivation practices associated with the adoption of DAS40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 soybean are not expected with the 

exception ofthose associated with the use or the timing of applications of certain phenoxy-auxin 

herbicides and ACCase inhibitor "fop" herbicides (pending EPA approval). These changes are 

not likely to increase plant diseases or pests or compromise their management. 

(7) Horizontal gene transfer of the new genetic material inserted into Enlist com and soybean to 

other organisms is highly unlikely, and is not expected to lead directly or indirectly to disease, 

damage, injury or harm to plants, including the creation of new or more virulent pests, 

pathogens, or parasitic plants. 

FINAL ENVIRONMENTAL IMPACT STATEMENT 

APHIS prepared an FEIS to examine the potential impacts on the human environment from 

determinations ofnonregulated status ofDAS-40278-9 com, DAS-68416-4 soybean, and DAS44406-6 soybean6

. APHIS evaluated potential impacts in the FEIS associated with the decision 

to approve the three petitions requesting a determination ofnonregulated status for each of the 

three Enlist events. A summary of the analyses contained in the FEIS is set forth below, in the 

6 The FEIS can be viewed at http://www.aphis.usda.gov/brs/aphisdocs/24d feis.pdf or under docket number APHIS2013-0042 at regulations.gov. 

Page6 
Record of Decision 

section entitled "Environmental Consequences Associated with the Determinations of 

Nonregulated Status under Alternative 2." 

Alternatives Considered in the FEIS 

Alternative 1: No Action Alternative- Continuation as a Regulated Article 

Under the No Action Alternative, APHIS would deny the three petitions seeking a determination 

ofnonregulated status ofDAS-40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 

soybean. All movements and environmental releases for Enlist com and soybean varieties would 

be subject to the regulations in 7 CFR part 340. Notifications or permits with conditions 

specified by APHIS would be required to move viable plant material and to plant it outdoors. 

Alternative 2: Deregulation ofDAS-40278-9 Corn, DAS-68416-4 Soybean, and DAS-44406-6 

Soybean 

Under Alternative 2, if Enlist com and soybean varieties were determined unlikely to pose a 

plant pest risk and all three Enlist events received nonregulated status, the Enlist com and 

soybean varieties and progeny derived from them would no longer be regulated articles under the 

regulations at 7 CFR part 340. APHIS Biotechnology Regulatory Service (BRS) permits or 

notifications would no longer be required for introductions of com and soybean derived from the 

Enlist com and soybean varieties. 

Alternative 3: Deregulation ofDAS-40278-9 Corn, Only 

Under Alternative 3, only DAS-40278-9 com and progeny derived from its cultivation would be 

granted nonregulated status and no longer be subject to the regulations at 7 CFR part 340. DAS68416-4 and DAS-44406-6 soybean would continue to be regulated as described under 

Alternative 1. APHIS would no longer require BRS permits or notifications for introductions of 

Enlist com and progeny derived from these events. APHIS made the determination that Enlist 

com and soybean varieties are unlikely to pose a plant pest risk to agricultural crops or other 

plants in the United States. Therefore, choosing this alternative would be inconsistent with the 

purpose and need of the project because it is inconsistent with the scientific evidence before 

APHIS regarding plant pest risk. 

Alternative 4: Deregulation of DAS-68416-4 Soybean and DAS-44406-6 Soybean, Only 

Under Alternative 4, only DAS-68416-4 and DAS-44406-6 soybean and progeny derived from 

their cultivation would be granted nonregulated status and no longer be subject to the regulations 

at 7 CFR part 340. DAS-40278-9 com would continue to be regulated as described under 

Alternative 1. APHIS would no longer require BRS permits or notifications for introductions of 

Enlist soybean and progeny derived from these events. APHIS made the determination that 

Enlist com and soybean varieties are unlikely to pose a plant pest risk to agricultural crops or 

other plants in the United States. Therefore, choosing this alternative would be inconsistent with 

the purpose and need of the project because it is inconsistent with the scientific evidence before 

APHIS regarding plant pest risk. 

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Record of Decision 

Major Issues Addressed in the FEIS 

The FEIS described the four alternatives considered and assessed the potential impacts of the 

deregulation of Enlist crops on the human environment. APHIS sought input from member of the 

public on issues and alternatives the Agency should consider in preparation ofthe EIS related to 

determinations ofnonregulated status ofDAS-40278-9 com, DAS-68416-4 soybean, and DAS44406-6 soybean. The resource areas considered in the FEIS were developed based upon the 

relevant concerns and issues identified in the Notice of Intent to prepare an EIS that APHIS 

published in the Federal Register on May 16, 2013. The following resource areas were assessed 

and evaluated by APHIS in the FEIS: 

• Food and Feed Safety 

• Worker Safety 

• Animal and Plant Communities 

• Socioeconomic Impacts 

o Domestic Use of Com and Soybeans 

o Export of Com and Soybean 

• Agronomic Inputs and Cost of Production 

• Land Use 

• Physical Environment 

o Surface and Ground Water Quality 

o Air Quality and Climate Change 

The scope of this EIS covered the direct and indirect impacts that would result from the 

cultivation and use of Enlist com and soybean. The EPA, in its registration process, is 

considering any direct and indirect impacts from herbicide use on Enlist crops

7

• Additionally, 

APHIS considered the FDA regulatory assessment in making its evaluation of the potential impacts 

of a determination of nonregulated status of Enlist com and soybean. DAS-40278-9 com would be 

the first commercially available food crop expressing the AAD-1 protein, while DAS-68416-4 

soybean and DAS-44406-6 soybean would be the first expressing the AAD-12 protein. DAS has 

submitted food and feed safety and nutritional assessments for DAS-40278-9 com, DAS-68416-4 

soybean, and DAS-44406-6 soybean to the FDA. At this time, the FDA considers the consultations 

on the Enlist crops to be complete8

• 

PUBLIC COMMENTS RECEIVED ON THE FEIS 

On August 8, 2014, APHIS published the FEIS for its determinations on petitions for 

nonregulated status ofDAS-40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 soybean. 

During the 30-day "review period" required under NEP A, 40 CFR § 1506.1 O(b )(2), APHIS 

received comments from the public on the FEIS. This 30-day review period closed on September 

7 The EPA docket for evaluation of2,4-D choline salt herbicide on Enlist com and soybeans (EPA-HQ-OPP-2014-

0 195) can be accessed at regulations.gov at this web address: http:/ /www.regulations.gov/#!docketDetail;D=EP AHQ-OPP-2014-0195. 

8 Completed FDA consultations (Biotechnology Notes to File (BNFs)) for DAS-40278-9 com (BNF No. 120), DAS68416-4 soybean (BNF No. 124), and DAS-44406-6 soybean (BNF No. 133) can be accessed at FDA's website: 

http://www.accessdata.fda.gov/scripts/fdcc/?set=Biocon. 

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Record of Decision 

8, 2014. APHIS received 969 total submissions. The majority of the 969 submissions did not 

support the deregulation ofDAS-40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 

soybean, with few submissions in support of deregulation. Three submissions from nongovernment organizations contained a total of240,670 signatures opposing the deregulation of 

Enlist crops. These submissions did not raise any new substantive issues with regard to the FEIS. 

These submissions expressed general concerns relating to pesticide use, GE plants, or DAS40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 soybean. Commenters opposed to the 

deregulation were concerned about the projected increased use of2,4-D on the Enlist crops 

impacting the environment, including impacts to natural resources and to sensitive plants and 

humans from herbicide drift. Additionally, some opposing commenters thought that a large 

increase in the use of2,4-D would result in the evolution of2,4-D-resistant weeds or multiple 

herbicide-resistant weeds, leading to the abandonment of conservation tillage practices which 

inevitably would increase soil erosion. However, such concerns and issues were previously 

assessed and addressed in the text and appendices of the FEIS. 

HERBICIDE USE 

APHIS has no statutory authority to authorize or regulate the use of2,4-D, glufosinate, 

quizalofop, glyphosate, or any other herbicide, by growers. Under APHIS' current part 340 

regulations, APHIS only has the authority to regulate DAS-40278-9 com, DAS-68416-4 

soybean, and DAS-44406-6 soybean or any GE organism as long as APHIS believes it may pose 

a plant pest risk. Any direct and indirect impacts associated with the expected increased use of 

2,4-D or other herbicides on Enlist com and soybean are outside the scope of this EIS because 

the authority to regulate the impacts ofherbicide use resides with the EPA under FIFRA. EPA's 

FIFRA registration decisions are based on scientific studies that assess the chemical's potential 

toxicity and environmental impact. To be registered, a pesticide must be able to be used without 

posing unreasonable risks to people or the environment. The EPA has conducted independent 

assessments of direct and indirect effects associated with the use of2,4-D on Enlist com and 

soybean and is making an independent action to determine whether to approve registration of the 

2,4-D and glyphosate premix, Enlist Duo9

• The EPA has also conducted assessments for the new 

use of quizalofop on DAS-40278-9 com as part of the requested label amendment for Assure® II 

Herbicide (EPA Reg. No. 352-541). 

APHIS' RECORD OF DECISION ON THE FEIS 

APHIS is selecting Alternative 2, approving the three petition requests for determinations of 

nonregulated status ofDAS-40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 soybean. 

This Record ofDecision on the FEIS is based on APHIS' full and complete review and 

consideration of all ofthe scientific and environmental data, analyses, information, and 

conclusions of the PPRAs; the FEIS; the public comments on the DEIS; the agency's response to 

comments on the DEIS; and comments on the FEIS. 

9 The EPA docket for evaluation of2,4-D choline salt herbicide on Enlist com and soybeans (EPA-HQ-OPP-2014-

0 19 5) can be accessed at regulations.gov at this web address: http:/ /www.regulations.gov/#!docketDetail;D= EPAHQ-OPP-2014-0195. 

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Record of Decision 

APHIS is selecting Alternative 2 of the FEIS because: 

• Alternative 2 best meets the purpose and need for agency action, which is to make a 

decision on these petitions consistent with the regulatory requirements in 7 CFR part 340. 

APHIS must respond to petitioners that request a determination of the regulated status of 

GE organisms, including GE plants such as DAS-40278-9 corn, DAS-68416-4 soybean, 

and DAS-44406-6 soybean. When a petition for nonregulated status is submitted, APHIS 

must make a determination if the GE organism is unlikely to pose a plant pest risk. If 

APHIS concludes, based on its PPRA, that the GE organism is unlikely to pose a plant 

pest risk, APHIS must then issue a determination of non-regulated status, since the 

agency does not have statutory authority to regulate GE organisms that are not plant 

pests. 

According to the PPRAs published on August 8, 2014, APHIS concluded that the Enlist 

corn and soybean events are unlikely to pose a plant pest risk. APHIS has therefore 

concluded that the selection of Alternative 2 in this Record of Decision is consistent with 

the plant pest provisions of the Plant Protection Act of2000, the regulations codified at 7 

CFR part 340, and the biotechnology regulatory policies in the Coordinated Framework. 

• APHIS reviewed the conclusions it reached in the FEIS on the environmental 

consequences of Alternative 2 and, in light of those conclusions, as well as those of the 

final PPRA, APHIS finds that Alternative 2 best serves the purpose and need for agency 

action as identified in the FEIS, as well as being in accord with APHIS' regulatory 

authority under 7 CFR 340. The environmental consequences of Alternative 2 are 

discussed in the next section. 

ENVIRONMENTAL CONSEQUENCES ASSOCIATED WITH THE 

DETERMINATIONS OF NONREGULATED STATUS UNDER ALTERNATIVE 2 

The following is a summary of the conclusions APHIS reached on the environmental 

consequences of Alternative 2. Under Alternative 2, Enlist corn and soybean could be planted, 

but no new herbicide uses, such as 2,4-D or quizalofop, would be allowed on these varieties. 

EPA regulates the use of herbicides under FIFRA and is making a separate decision on the use of 

2,4-D and quizalofop on these plants. 

Food and Feed Safety 

• Under the Alternative 2, Enlist corn and soybean would be commercially available to 

growers who would be able to grow, harvest, and move their crop into commerce for 

food and feed. Enlist corn and soybean have been shown to be compositionally similar to 

currently available varieties of corn and soybean. These events are not expected to have 

different nutritional qualities than other available corn or soybean varieties. Dow 

submitted safety and nutritional assessments to the FDA, providing information on the 

characterization, composition, allergenicity, and toxicity of the proteins inserted in DAS40278-9 corn, DAS-68416-4 soybean, and DAS-44406-6 soybean. The FDA evaluated 

the information in Dow's submissions to ensure that regulatory and safety issues 

regarding human food and animal feed derived from the new plant varieties have been 

resolved prior to commercial distribution. Dow concluded that foods and feeds derived 

Page 10 
Record of Decision 

from Enlist com and soybean are as safe as conventional com and soybean varieties and 

are not materially different in composition or any other relevant parameters from other 

com and soybean varieties now grown, marketed, and consumed in the United States. 

The FDA did not identify any issues under the Federal Food, Drug, and Cosmetic Act 

that would require further evaluation at this time and the consultations were completed 

with the FDA on these events. Under Alternative 2, there are not likely to be any effects 

associated with consumption of food and feed containing Enlist com and soybean when 

compared to the No Action Alternative. 

• The AAD-1 protein in DAS-40278-9 com is derived from the common gram-negative 

soil bacterium Sphingobium herbicidovorans (Herman et al., 2010)10• Sphingobium is a 

member of the sphingomonads, a widely distributed bacteria group isolated from soil and 

water as well as plant root systems (DAS, 2009; DAS, 201 Ob ). The sphingomonads have 

been used widely in biotechnology applications, including bioremediation of 

environmental contaminations as well as production of sphingans, bio-based polymers 

which are used in the food industry (Pollock and Armentrout, 1999; Lal et al., 2006; 

DAS, 2010a). Considering this safe history ofuse, under the Alternative 2, there are not 

likely to be any effects associated with consumption of food and feed containing the 

AAD-1 protein in DAS-40278-9 com when compared to the No Action Alternative. 

• The AAD-12 protein in DAS-68416-4 and DAS-44406-6 soybean is derived from the 

common gram-negative soil bacterium Delftia acidovorans. D. acidovorans is non 

glucose-fermenting, gram-negative, non-spore-forming rod type bacterium present in 

soil, fresh water, activated sludge, and clinical specimens. It has a history of safe use in 

the food processing industry, including having been used in transforming ferulic acid into 

vanillin and related flavor metabolites (DAS, 2010a). Because the AAD-12 protein has a 

safe history of use in food processing, under the Alternative 2, there are not likely to be 

any effects on humans or animals consuming food and feed, respectively, from Enlist 

soybean when compared to the No Action Alternative. 

• The pat gene is derived from Streptomyces viridochromogenes, a gram-positive soil 

bacterium. The pat gene conveys resistance to glufosinate (Wohlleben et al., 1988). The 

PAT protein in DAS-68416-4 and DAS-44406-6 soybean is the same as that used as a 

selectable marker during development and to confer herbicide resistance in other 

previously deregulated GE crops (Brenner et al., 2001; USDA-FAS, 2004; USDA-ERS, 

2005; Duke and Powles, 2008). Additionally, FDA has previously reviewed submissions 

regarding the safety of food and feed derived from crops containing the pat gene 

(Biotechnology Notification Files (BNFs) 000055, 000073, 000081, 000085, and 

000092). Because the PAT protein expressed in DAS-68416-4 and DAS-44406-6 

soybean has already been evaluated by FDA and soybean (and other crops) containing 

the pat gene are already in commerce, there are not likely to be any effects on humans 

and animals consuming food and feed, respectively, from Enlist soybean when compared 

to the No Action Alternative. 

1

° Citations for references may be found in the FEIS. 

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• The mepsps gene in DAS-44406-6 is derived from Zea mays, com. It contains two 

mutations which convey resistance to glyphosate (Lebrun and Leroux, 1996; Lebrun et 

al., 2003). It is similar to the epsps gene expressed in GA21 com, GHB614 cotton, and 

HCEM485 com which have been deregulated by APHIS. GA21 com (BNF 51), GHB614 

cotton (BNF 1 09), and HCEM485 com (BNF 1 06) have completed consultations with 

FDA. Because of the similarity of the EPSPS protein expressed in DAS-44406-6 and the 

com and cotton varieties noted above, under the Alternative 2, there are not likely to be 

any effects on humans and animals consuming food and feed, respectively, from Enlist 

soybean when compared to the No Action Alternative. 

Worker Safety 

• APHIS has not identified any direct or indirect effects on worker safety that would result 

from choosing the Alternative 2. Under Alternative 2, the availability ofDAS-40278-9 

com, DAS-68416-4 soybean, and DAS-44406-6 soybean would not change the 

agronomic management practices used in the cultivation of com and soybean. Potential 

hazards to workers associated with the various agronomic management practices used to 

grow com and soybean would be the same as those under the No Action Alternative. The 

decision to approve the three petitions does not authorize a change in herbicide use on 

these com or soybean varieties. The EPA regulates the use of herbicides under FIFRA 

and considers the effects on human health when approving the use of herbicides. The 

EPA, in its registration process, is considering any direct and indirect impacts from the 

new use of herbicides on Enlist crops. 

Biological Resources 

Animal Communities 

• Animals found in the vicinity of agricultural fields ofDAS-40278-9 com, DAS-68416-4 

soybean, or DAS-44406-6 soybean would continue to feed on com and soybean in these 

fields. These com and soybean varieties have been shown to be compositionally similar 

to other commercially available com and soybean varieties. As detailed under "Food and 

Feed," the PAT and mEPSPS proteins are found in commercial varieties of com, cotton, 

and soybeans. Organisms that feed on these crops are exposed to these proteins in 

previously deregulated varieties with no documented negative effects. Dow completed 

consultations with FDA ensuring that regulatory and safety issues regarding human food 

and animal feed derived from the new plant varieties have been resolved prior to 

commercial distribution. No potential impacts to animal communities from consumption 

and exposure to Enlist com and soybean are anticipated under the Alternative 2 in 

comparison to the No Action Alternative. 

• Animals can also be impacted indirectly by agricultural practices, such as tillage and 

herbicide use. Adopting Alternative 2 will not result in any changes in agricultural 

practices in comparison to the No Action Alternative. Growers will continue to use EPAapproved herbicides and cultural practices to manage weeds. Increases in tillage to 

control weeds can increase soil erosion and indirectly impact wildlife. Agricultural 

production of com and soybean would continue to use currently EPA-registered 

pesticides for weed management. The environmental risks of pesticide use on wildlife 

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Record of Decision 

and wildlife habitat are assessed by EPA in the pesticide registration process and are 

regularly reevaluated by EPA for each pesticide to maintain its registered status under 

FIFRA. 

Plant Communities 

• Under Alternative 2, the direct and indirect effects of approving these three petitions on 

plant communities would be similar to the effects on plants under the No Action 

Alternative. Enlist com and soybean have been shown to be agronomically similar to 

conventional com and soybean varieties currently in cultivation. Thus, choosing 

Alternative 2 would not change the agronomic practices used in the cultivation of com 

and soybean and, therefore, would not change the potential impacts to the plant 

communities in or around com and soybean fields. Agronomic practices, such as 

herbicide use and mechanical cultivation (i.e., tillage), can select for weeds that are 

adapted to these management practices. Non-target plant communities in areas 

surrounding production fields would continue to be exposed to the effects associated with 

agricultural production. This can select for resistance to herbicides among these 

populations, just as in production fields, resulting in establishment of novel resistant 

biotypes. Exposure to herbicide, e.g., through drift could also lead to plant population 

shifts in non-target populations, just as it could in weed populations associated with 

production fields. 

• APHIS' decision to approve the three petitions as described in Alternative 2, does not in 

any manner authorize or approve any herbicide use on these com or soybean varieties. 

APHIS has no regulatory authority over the use and application of herbicides or 

pesticides. EPA regulates the use of herbicides under FIFRA and is making a separate 

decision on the new uses of herbicides on these plants. Therefore, there are no changes to 

the potential effects to plant communities under Alternative 2 when compared to the No 

Action Alternative. 

Socioeconomics 

• Enlist com and soybean have been shown to be compositionally similar to currently 

available varieties of com and soybean and, therefore, are suitable for use in food, feed, 

and industrial applications. As a result, under Alternative 2, there are no expected direct 

or indirect effects associated with the cultivation of these events on the domestic use of 

com and soybean. 

• As with the No Action Alternative, under Alternative 2, growers of specialty value added 

com and soy crops, including organic com and soybean, would see production and 

demand for these value added crops unchanged by nonregulated status of the Enlist crops. 

• Dow has submitted applications to various international regulatory authorities for food, 

feed, and/or cultivation approvals. Approvals for one or more of the Enlist crops have 

occurred in some countries and are pending in others. Although the primary U.S. com 

and soybean export destinations do not present major barriers in the trade of GE products, 

Dow will need to obtain approvals for DAS-40278-9 com, DAS-68416-4 soybean, and 

DAS-44406-6 soybean in destination countries before commercialization to avoid 

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Record of Decision 

adversely affecting current trade flows. In some export markets where Enlist com or 

soybean are not approved from import or for non-genetically modified, identity-preserved 

com or com flour shipments, testing for the presence of Enlist com or soybean may be 

required. If a new type of test would be needed for Enlist com and soybean, current 

testing costs may increase by 10 to 15 percent. 

Land Use and Physical Environment 

• Land use for com and soybean production is driven by the price of com and soybean, as 

well as the suitability of the land for production of these crops. As a result, the 

availability of Enlist com and soybean would not have any direct or indirect effects on 

land use under Alternative 2 in comparison to the No Action Alternative. 

• Under Alternative 2, growers of specialty value added com and soybean crops would see 

production and demand for these value added crops unchanged by nonregulated status for 

the three varieties. 

• Under Alternative 2, Enlist com and soybean are not expected to have any different 

potential impacts on soils, climate or air quality, or water than those under the No Action 

Alternative. These natural resources are affected by agricultural practices, particularly 

those associated with weed management, such as tillage and herbicide use. The decision 

to approve these petitions will not directly or indirectly affect grower decisions to use 

tillage or herbicides to manage weeds. Under Alternative 2, Enlist com and soybean 

could be planted but no new herbicide uses would be allowed on these varieties. EPA 

regulates the use of herbicides under FIFRA and is making a separate decision on the use 

of2,4-D on these plants. 

Threatened and Endangered Species 

APHIS, as described below, evaluated the potential effects that the three determinations of 

nonregulated status ofDAS-40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 soybean 

may have, if any, on federally-listed threatened and endangered species (TES) and species 

proposed for listing, as well as designated critical habitat and habitat proposed for designation. 

For its analysis of potential effects on TES plants and critical habitat, APHIS focused on the 

agronomic differences between the regulated articles (Enlist com and soybean) and com and 

soybean varieties currently grown; the potential for increased weediness; and the potential for 

gene movement to native plants, listed species, and species proposed for listing. For its analysis 

of potential effects on TES species, APHIS focused on the implications of exposure of the novel 

proteins expressed in the plants as a result of the transformation, and the ability of the plants to 

serve as a host for a TES. 

APHIS concluded that the determinations ofnonregulated status ofDAS-40278-9 com, DAS68416-4 soybean, and DAS-44406-6 soybean and the corresponding environmental releases of 

these com and soybean varieties are not expected to affect listed species or species proposed for 

listing, and would not affect designated habitat or habitat proposed for designation. 

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Record of Decision 

• Based on a lack of weediness in Enlist com and soybean, APHIS concluded that 

availability of Enlist com and soybean would not extend the range of com and soybean 

production or lead to cultivation on land not previously used for agricultural production. 

• APHIS considered as part of the analysis forTES and critical habitat if the new 

phenotype imparted to Enlist com and soybean may allow the plant to naturalize in the 

environment and potentially have an effect on TES. No differences were detected 

between Enlist com and soybean and conventional varieties in growth, reproduction, or 

interactions with pests and diseases, other than the intended effect of herbicide tolerance. 

Based on agronomic field data and a survey of scientific literature on weediness potential, 

the inserted genes do not alter weediness potential of Enlist com and soybean, and thus 

these varieties are unlikely to affect TES or critical habitat as troublesome or invasive 

weeds. 

• After reviewing the list of threatened and endangered plant species or plants proposed for 

listing in the states where com and soybean are grown, APHIS concluded that Enlist com 

and soybean would not be sexually compatible with any listed species or species 

proposed for listing, as none of these listed plants are in the same genus nor are known to 

cross pollinate with species of the genus Zea or Glycine. 

• Compositional analysis ofDAS-40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 

soybean demonstrated that Enlist com and soybean are compositionally equivalent to 

conventional com and soybean with respect to key nutrients and components. 

Additionally, Dow submitted food and feed safety and nutritional assessments for Enlist 

com and soybean to the FDA and completed their consultations with the FDA. 

Consequently, Enlist com and soybean are not expected to have adverse nutritional 

effects on any animal that feeds upon them. 

• Safety evaluations conducted by Dow included evaluations of the protein structure and 

function of Enlist com and soybean, including homology searches of the amino acid 

sequences with comparison to all known allergens and toxins, and in vitro digestibility 

assay of the proteins, and acute oral toxicity feeding study in mice, and a feeding study in 

broiler chickens. Enlist com and soybean proteins were determined to have no amino acid 

sequences similar to known allergens, lacked toxic potential to mammals, and degraded 

rapidly and completely in gastric fluid. APHIS concluded that no substantial differences 

exist compared to conventional com or soybean and consumption of Enlist com or 

soybean by any listed species or species proposed for listing will not result in a toxic or 

allergic reaction. 

• APHIS evaluated whether Enlist com and soybean could serve as host plants for TES or 

listed species (i.e., a listed insect or other organism that may use the com or soybean 

plant to complete its lifecycle ). A review of the species list indicated there are no TES or 

species proposed for listing that use com or soybean as a host plant. 

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Record of Decision 

ENVIRONMENTAL ALTERNATIVE 

The environmental alternative is not only the alternative that causes the least harm to the 

biological and physical environment, but also the alternative which best protects, preserves, and 

enhances historic, cultural, and natural resources. APHIS analyzed the impacts of four 

alternatives on the human environment in detail in the FEIS. Because there is no difference in the 

potential impacts among the alternatives when compared to the No Action Alternative, APHIS 

has not identified an Environmentally Preferred Alternative as per 40 CFR 1505.2(b). 

Under Alternatives 2, no direct or indirect effects associated with growing DAS-40278-9 com, 

DAS-68416-4 soybean, and DAS-44406-6 soybean were identified as being different when 

compared to the direct and indirect effects associated with growing com and soybeans in the No 

Action Alternative, because these GE varieties are not agronomically different from non-GE 

com and soybean plants or other GE com or soybean plants that are no longer regulated by the 

Agency. APHIS determined that the deregulation and commercial availability of Enlist com and 

soybean varieties would not result in an increase in com and soybean acreage in areas already in 

com and soybean production or result in changes in where com and soybean are currently grown. 

In addition, these three GE plant varieties would not affect natural (e.g., soil, water, air, and 

climate) or biological (e.g., animal, insect, plant) resources any differently than those com and 

soybean varieties currently grown under the No Action Alternative. 

The continued emergence of glyphosate-resistant weeds under the No Action Alternative will 

itself call for modifications of agronomic management practices to address these weeds. Growers 

will likely continue to use glyphosate because it is still effective on hundreds of weed species, 

but will become less reliant on glyphosate for the control of weeds it is no longer effective in 

controlling. Farmers are expected to use additional non-glyphosate herbicides and non-chemical 

methods, such as crop rotation and tillage practices, to control these glyphosate-resistant weeds. 

Herbicide-resistant weeds would continue to be selected for by the agronomic management 

practices growers choose to adopt. 

Under Alternative 2, as with the No Action Alternative, growers may continue to rely on 

glyphosate, other EPA-approved herbicides, and other non-chemical methods to manage weeds 

in com and soybean. They could not apply herbicides differently on Enlist com or soybean than 

currently allowed on other com and soybean varieties. That is because Enlist Duo is not 

registered for use on these com or soybean events until EPA approves the label. Therefore, 

herbicide-resistant weeds would be selected for by agronomic management practices in the same 

ways that they are in the No Action Alternative. 

The potential impacts on each resource that derives from herbicide use are outside the scope of 

this EIS because the EPA is the federal agency responsible for the analysis of these impacts. The 

EPA has thoroughly analyzed the potential impacts of proposed new uses of Enlist Duo as part of 

their pesticide registration process. The expected increased use of2,4-D on DAS-40278-9 com, 

DAS-68416-4 soybean, and DAS-44406-6 soybean has the potential to impact the selection of 

herbicide resistance in weeds due to the use of2,4-D as an herbicide, and not due to any 

properties of Enlist com and soybean plants themselves. Measures EPA is proposing to include 

on the Enlist Duo label addressing this potential development of resistant weeds are discussed in 

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Record of Decision 

the following section discussing mitigations of impacts. Weed scientists will continue to 

encourage growers to use best management practices like under the No Action Alternative. 

As a result, the direct and indirect impacts on each resource area for Alternative 2 are the same 

as for the No Action Alternative. Under Alternative 2, none of these three events (DAS-40278-9 

com, DAS-68416-4 soybean, and DAS-44406-6 soybean), either individually or together, would 

have different effects on the human environment than the No Action Alternative. Therefore, 

approving the petition for deregulation of Enlist com under Alternative 3 or Enlist soybean under 

Alternative 4 is also not expected to have different direct and indirect effects on resource areas in 

comparison to the No Action Alternative. Because there is no difference in the potential impacts 

among the alternatives, there is no environmentally preferable alternative. 

MITIGATIONS OF IMPACTS ASSOCIATED WITH ALTERNATIVE 2 

In an analysis of Cumulative Impacts, the independent action by EPA to approve registration of 

Enlist Duo, a premix of2,4-D choline salt and glyphosate, for use on Enlist crops is reasonably 

foreseeable. APHIS concluded that the potential increased use of2,4-D associated with 

cultivation of Enlist com and soybean is expected to increase the pressure for selection of2,4-Dresistant weeds, as management regimes that incorporate only a single herbicide are more likely 

to result in selection of weeds resistant to that herbicide. APHIS also acknowledges that the 

availability of dicamba-resistant soybean (called X tend soybean) varieties on the market is 

reasonably foreseeable. The EPA is conducting independent assessments of direct and indirect 

effects associated with the use of dicamba on Xtend soybean to determine whether to approve 

this new dicamba registration. It is reasonable foreseeable that EPA will approve the registration 

of the new use of dicamba on X tend soybean, although the details of the registration are not 

known at this time. The potential increased use of dicamba associated with growing ofXtend 

soybean is expected to increase selection pressure of dicamba-resistant weeds if the herbicide is 

used without rotating to other herbicides. Dicamba and 2,4-D are both synthetic auxins with very 

similar herbicide chemistries, however they are not likely to be used simultaneously. Cultivation 

ofherbicide-resistant crops is not the cause of herbicide-resistant weeds, but results from the 

failure of growers to apply best management practices in the production of herbicide-resistant 

crops. 

Growers may mitigate the rate at which weeds develop resistance by the agronomic practices 

they choose. The impact of increased 2,4-D or dicamba use on the selection of2,4-D- or 

dicamba- resistant weeds may be mitigated by use of best management practices. Some examples 

of the practices that can be followed to reduce or delay the selection ofherbicide-resistant weeds 

include, rotating crops, rotating types of herbicides, using cover crops, scouting for weeds, and 

using mechanical tillage to prevent weeds from flowering. Resistance to 2,4-D or dicamba 

represents no more of a threat to agricultural production than resistance to other critical 

herbicides, and the likelihood that it will be used in a manner consistent with best management 

practices is good. Farmers are aware ofthe problems of resistant weed biotypes and are 

increasingly proactive in the identification and removal of new weeds. Societies such as the 

Weed Science Society of America, university extension agents, and industry, have made a 

concerted effort to increase grower awareness of best management practices for herbicideresistant weeds. 

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Record of Decision 

When considering cumulative impacts for Alternative 2, 2,4-D use is expected to increase ifEPA 

approves the amended use of2,4-D on the Enlist crops. However, increases in other herbicide 

sites of action under Alternative 2 are expected to be less than under the No Action Alternative 

because the Enlist Duo herbicide are expected to be preferentially adopted if approved for use on 

these crops by EPA. The availability of inexpensive and effective herbicides in Enlist Duo 

combined with Enlist com and soybean may delay the adoption of non-chemical management 

strategies. Fewer growers would be expected to adopt aggressive tillage when herbicides remain 

effective for weed control. Selection of weeds resistant to glyphosate and non-glyphosate 

herbicides will still occur. The selection pressure for herbicide-resistant weeds will depend on 

the agronomic management practices employed under each alternative and cannot be predicted. 

More diversified weed management practices will result in less selective pressure for resistance 

to any given herbicide or management technique. 

APHIS does not have the authority to regulate grower management practices. Further, APHIS 

has no authority to regulate herbicide use or to impose any mitigation measures with regard to 

the use of any herbicides, including 2,4-D. Under FIFRA, the EPA registers pesticides and 

prescribes the conditions for use of the pesticide. The EPA must ensure that the pesticide, when 

used according to label directions, will not cause unreasonable adverse effects to human health 

or the environment. Mitigation measures to oversee the proper usage of herbicides are 

determined by the EPA and specified on the EPA-approved pesticide labels. Applying pesticides 

in a way that is inconsistent with the label is illegal. 

Recognizing the increasing economic issues resulting from herbicide-resistant weeds, the EPA is 

including measures to address weed resistance as part of the registration terms for Enlist Duo 11 • 

Best management practices for helping prevent the development of resistant weeds will appear 

on the Enlist Duo label, including: rotating herbicide chemistries, limiting herbicide applications 

per season; scouting fields both before and after herbicide treatment; incorporating non-chemical 

weed control strategies, and preventing weeds from setting seed. 

Additionally, the EPA is requiring that Dow develop a stewardship program with its customers 

that will aggressively promote resistance management efforts, with an overall goal to assist and 

support responsible use of the product. The program mandates that Dow must immediately 

investigate any claims of non-performance and take immediate action to eradicate weeds 

identified as likely resistant weeds. Additionally, the stewardship program also includes 

educating and training retailers, farmers, and applicators on the appropriate use of Enlist 

technology, reporting verified cases of resistance to Enlist Duo to interested parties, developing 

diagnostic testing for evaluating resistant weed species, and monitoring whether Enlist Duo is 

being used on Enlist seed. 

EPA has determined that the registration must contain a term that requires DAS to submit annual 

summary reports to EPA that include a summary of the number of instances of likely and 

confirmed weed resistance by weed species, crop, county and state. EPA believes that it is 

11 EPA's registration decision, including daft label, risk assessments, and analyses, on the registration of Enlist Duo 

can be accessed at regulations.gov at this web address: http:/ /www.regulations.gov/#!docketDetail;D=EP A-HQOPP-2014-0195. 

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Record of Decision 

important to address likely weed resistance and not wait until confirmation of resistance has been 

found. Because the issue of weed resistance is an extremely important issue to keep under 

control and can be very fast moving, EPA has determined that the registration must contain terms 

that ensure that EPA retains control to easily and quickly modifY or cancel the registration if 

necessary. 

There is increasing awareness ofherbicide stewardship needs among growers. Industry, 

academia and weed science professionals are providing more tools to help growers adopt the 

farming practices that will both delay the selection of herbicide resistance and help control the 

spread of herbicide-resistant weeds from field to field. The likelihood of success will depend on 

the extent to which growers rely exclusively on Enlist Duo versus employing a range of other 

management techniques. Because oflosses recently experienced with glyphosate-resistant 

weeds, growers may be more motivated to employ best management practices. 

REQUEST TO ADD THE THREE ENLIST EVENTS TO THE APHIS FEDERAL 

NOXIOUS WEED LISTING 

As mentioned above, on January 10, 2014, APHIS published the DEIS for the petitions for 

determination of nonregulated status for Enlist com and soybean for public review and comment 

(79 FR 1861) and the DEIS was available for public comment for a 60-day comment period 

which closed on March 11,2014. APHIS received over 10,090 public comments on its DEIS. A 

commenter that provided comments on the DEIS included a specific request for APHIS to 

consider the commenter's comments simultaneously as a noxious weed petition to APHIS and 

for APHIS to apply its noxious weed authority to the proposed deregulation of the three Enlist 

events. APHIS has accepted that noxious weed petition pursuant to 7 CFR 360.500, "Petitions to 

Add a Taxon to the Noxious Weed List," requesting that APHIS list DAS-40278-9 com, DAS68416-4 soybean, DAS-44406-6 soybean, and their progeny as Federal noxious weeds, and will 

evaluate that petition separately pursuant to those regulations. 

APHIS, in its Response to Comments section of the FEIS, addressed that noxious weed petition 

that was included with the commenter's comments on the DEIS. APHIS explained to the 

commenter that APHIS regulates plant pests and noxious weeds under two separate and distinct 

regulatory frameworks. A petition for a determination of nonregulated status of a GE organism is 

evaluated pursuant to APHIS' 7 CFR part 340 regulations, and pursuant to that regulation, 

APHIS makes such a determination on the basis of whether the GE organism is likely to pose a 

plant pest risk. On the other hand, a petition to list some organism as a noxious weed is evaluated 

under APHIS' 7 CFR part 360 regulations, and pursuant to those regulations, APHIS makes a 

determination on the basis of whether the organism should be listed on APHIS' noxious weed 

list. APHIS noted in its response to that comment that the commenter acknowledged the separate 

regulatory framework of 7 CFR part 340 and 7 CFR part 360 by submitting several pages of 

comments to the DEIS specifically as a noxious weed petition. APHIS informed the commenter 

that it accepted the commenter's noxious weed petition and that it would be evaluated separately. 

APHIS has also sent the commenter a letter acknowledging its request. APHIS will evaluate the 

commenter's noxious weed petition based on an analysis of available scientific data, a weed risk 

assessment, and other available information; and when such evaluation is complete will inform 

the petitioner and the public of their decision on the noxious weed petition. 

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Record of Decision 

COMPLIANCE WITH APPLICABLE LAWS, EXECUTIVE ORDERS, AND 

REGULATIONS 

This Record ofDecision has been prepared in accordance with: (1) the National Environmental 

Policy Act (NEP A), (2) regulations ofthe Council on Environmental Quality for implementing 

the procedural provisions ofNEP A ( 40 CPR parts 1500-1508), (3) USDA regulations 

implementing NEP A (7 CPR part 1 b), and ( 4) APHIS' NEP A Implementing Procedures (7 CPR 

part 372). 

The Record ofDecision considered the directives of Executive Order (EO) 12898 (US-NARA, 

2008), "Federal Actions to Address Environmental Justice in Minority Populations and LowIncome Populations;" EO 13045, "Protection of Children from Environmental Health Risks and 

Safety Risks;" EO 13112 "Invasive Species;" EO 13186, "Responsibilities of Federal Agencies 

to Protect Migratory Birds;" and EO 12114, "Environmental Effects Abroad ofMajor Federal 

Actions." 

The Record of Decision was determined to be compliant with other Federal Statutes including, 

the Clean Water Act; the Clean Air Act; the National Historic Preservation Act of 1966 as 

amended; and the Endangered Species Act. 

Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Service 

U.S. Department of Agriculture 

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Date