Record ofDecision

In this Record ofDecision (ROD), APHIS is announcing the agency's environmental decision on the alternatives examined inthe FEIS. In accordance with its statutory authority and following the publication ofits 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 ofthe Federal agencies withregulatoryresponsibilities under the 1986 Federal Coordinated Framework for the Regulation ofBiotechnology (hereafter Coordinated Framework) published bythe Office ofScience and Technology Policy, Executive Office ofthe President. The Coordinated Framework is a policy statement which "describes the comprehensive Federal regulatorypolicy for ensuring the safety ofbiotechnologyresearch 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 inthe frequent situations in which a statute leaves the implementing agencylatitude for discretion. To that end, the Office ofScience and Technology Policypublished a notice ofFederal policy in the Federal Register in 1992 in which it set forth "theproperbasis for agencies' exercise ofoversight authority within the scope ofdiscretion afforded by statute." The notice describes: "arisk-based, scientifically sound approach to the oversight ofplanned introductions of biotechnologyproducts into the environment that focuses onthe characteristics ofthe biotechnologyproduct and the environment into which it is being introduced, not the process bywhich the product is created. Exercise ofoversight inthe scope ofdiscretion afforded by statute should bebased on the risk posedbythe introduction and should not tum on the fact that an organism has beenmodified by a particularprocess ortechnique." The policy statement of 1992 states further:

Page2 "In order to ensure that limited federal oversight resources are applied where theywill accomplish the greatest netbeneficial protection ofpublic health and the environment, oversight will be exercised onlywhere the riskposed bythe introduction is unreasonable, that is, when the value ofthe reduction inrisk obtained by additional oversight is greater than the cost therebyimposed. The extent and type ofoversight measure(s) will thus be commensurate with the gravity and type ofrisk being addressed, the costs ofalternative oversight options, and the effect ofadditional oversight on existing safetyincentives."

# Record ofDecision

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 ofAgriculture (USDA) Animal and Plant Health Inspection Service (APHIS) completed and published a Final Environmental Impact Statement (FEIS) after receiving threepetitions submittedbyDow AgroSciences LLC, oflndianapolis, Indiana (Dow), seeking determinations ofnonregulated status for com and soybean cultivars genetically engineered to beresistant to herbicides. The first petition, APHIS PetitionNumber 09-233-01p, seeks a determination ofnonregulated status for com (Zea mays) designated as event DAS40278-9. This eventhas been genetically engineered for increased resistance to certainbroadleaf herbicides in the phenoxy auxin group (particularlythe 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 PetitionNumber 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 broadleafherbicides in thephenoxy auxin growth regulator group (particularlythe herbicide 2,4-D) and the nonselective herbicide glufosinate. The third petition, APHIS PetitionNumber 11-234-0lp, seeks a determination ofnonregulated status for soybean designated as event DAS-44406-6, which has been genetically engineered for resistance to certainbroadleafherbicides inthe auxin growth regulator group (particularlytheherbicide 2,4- D) and the nonselective herbicides glyphosate and glufosinate.
The petitions state that these articles are unlikely to pose a plant pestrisk and, therefore, should not beregulated articles under APHIS' regulations in 7 Code ofFederal Regulations (CFR) part 340. These part 340 regulations are authorizedbythe Plant Protection Act to prevent the introduction or dissemination ofplant 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 ofDecision

The Coordinated Framework explains theregulatory roles and authorities for the three major agencies involved inregulating GE organisms: USDA APHIS, the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA).
EPA Regulation ofBiotechnology The EPA is responsible for regulating the sale, distribution, and use ofpesticides, including those that are expressed by an organism modified using techniques ofmodembiotechnology, identified as plant-incorporatedprotectants 1• The EPA regulates these plant-incorporated protectants (PIPs) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, etseq.) and certainbiological control organisms under the Toxic Substances Control Act (TSCA) (15 U.S.C. 53, etseq.). Before planting a crop containing a PIP, a companymust seek an experimental use permit from EPA. Commercial production ofcrops containing PIPs for purposes ofseed increases and sale requires a FIFRA Section 3 Registration with EPA. Before EPA can register a pesticide there mustbe sufficient data demonstrating that it will not pose unreasonable risks to humanhealth orthe environment when used according to label directions. When assessing the potential risks ofgenetically engineered PIPs, EPA requires extensive studies examining numerous factors, such as risks to humanhealth, nontarget organisms and the environment, potential for gene flow, and the need for insect resistance managementplans.
FDA Regulation ofBiotechnology The FDA regulates GE organisms under the authority ofthe Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 etseq.). The FDA published its policy statement concerning regulation ofproducts derived from new plant varieties, including those derived from genetic engineering, onMay 29, 1992 (57 FR22984). Under this policy, the FDA implements a voluntary consultationprocess to ensure that human food and animal feed safety issues or otherregulatory issues, such as labeling, are resolved before commercial distribution offood derived from GE products2

. APHIS Regulation ofBiotechnology
In 1987, APHIS promulgated its biotechnologyregulations (7 CFRpart 340) under the authority ofthe Federal Plant Pest Act (FPPA) and the Plant Quarantine Act (PQA) 3 to address potential

1 A list ofEPA Current and Previously Registered Section 3 PIP Registrations canbe found here: http://www.epa.gov/pesticides/biopesticides/pips/pip _list.htm. 2 A list ofall completed Biotechnology consultations on Genetically Engineered foods evaluatedunder FDA's 1992 Statement ofPolicy: Foods Derived from NewPlant Varieties canbe found here: http://www.accessdata.fda.gov/scripts/fdcc/?set=Biocon. 3 The FPPA and PQAwere consolidated along with other statutory authorities into the Plant Protection Act of2000, in which Congress found that: "it is the responsibility ofthe Secretary to facilitate exports, imports, and interstate commerce in agricultural products and other commodities thatpose a risk ofharboring plantpests

... in ways that will reduce, to the extentpracticable, as determined bythe Secretary, the risk ofdissemination ofplantpests

... ; decisions affecting imports, exports, and interstate movement ofproducts regulated under this title shall be based on sound science

...." The Plant ProtectionAct of2000 defmes a plantpest as: PLANT PEST-The term ''plantpest'' means any living stage ofany ofthe following that can directly or indirectly injure, cause damage to, or cause disease in anyplant orplant product: (A) A protozoan. (B) A nonhuman animal.
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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 CFRpart 340 were amended in 1993 to provide a procedure for the deregulation (i.e., a petition for nonregulated status) ofsuch GE plants which are unlikely to present a plantpestrisk and, therefore, should no longer be regulated. 7 CFR 340.6 describes the process for submittingpetitions for nonregulated status, the data requirements, and actions that the APHIS Administratormaytake onthe petition. Itis under this procedure that APHIS received petitionrequests 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 onAugust 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.
Inresponse to the receipt ofthe three Dowpetitions, APHIS prepared plant pestrisk assessments (PPRAs) to assess the plantpestrisk for each plant varietypursuant to the Plant Protection Act. APHIS also examined the environmental impacts ofits potential regulatory decisions for nonregulated status ofEnlistTM com and soybeanpursuant to theNational Environmental Policy Act(NEPA). FederalRegister notices sought public comments ontwo 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 ofthese two petitions. An EA was not prepared for the third petition, 11-234-01p (DAS-44406-6 soybean), so that notice only sought comments for the petition. After APHIS initiated its NEPA process bypreparing the two EAs, APHIS carne to the decision that it was appropriate to use one NEPA 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 ofall three ofthe Enlist petitions.
On January 10, 2014, APHIS published a FederalRegister notice ofavailability for the draft PPRAs and the draft environmental impact statement (DEIS) for the petitions for determination ofnonregulated status for Enlist com and soybean for publicreview and comment (79 FR 1861).
(C) A parasitic plant. (D) A bacterium. (E) A fungus. (F) A virus orviroid. (G) Aninfectious agent or otherpathogen. (H) Any article similar to or allied with any ofthe articles specified in the preceding subparagraphs. (7 U.S.C. §7702(14)

4 A "regulated article" is defmed as: "Any organism whichhas been altered orproduced through genetic engineering, ifthe donor organism, recipient organism, or vector orvector agentbelongs to any genera or taxa designated in§ 340.2 and meets the defmition ofplantpest, oris anunclassified organism and/or an organism whose classification is unknown, or anyproduct which contains such an organism, or any other organism orproduct altered orproduced through genetic engineering which the Administrator, determines is a plantpest orhas reason to believe is a plantpest. Excluded are recipient microorganisms which are notplantpests and which have resulted from the addition ofgenetic material from a donor organism where the material is well characterized and contains only non-coding regulatoryregions." (7 CFR 340.0)
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The PPRAs and DEIS were available for public comment for a 60-day commentperiod 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 ofthe three Enlist varieties. The remaining 125 comments were submissions of attachments, requests for extensions, or were submissions to an incorrect docket. Some ofthe submissions in support or opposition were petitions with signatures, letters with multiple signatures, orbatches ofnearly identical letters. In addition, APHIS conducted a virtual public meeting onJanuary 29, 2014, at which a total of24participants provided comments (9 opposed to and 15 in favor ofderegulation). APHIS reviewed and evaluated all ofthe public comments received onthe DEIS for the three Enlist petitions and prepared formal responses to them as part ofthePEIS. On August 8, 2014, a Notice in the FederalRegister announced the availability ofthe PEIS to the public. Additionally, APHIS distributed the PEIS to all interested individuals who had specificallyrequested a copy of the PEIS and also posted it on its website5• PURPOSE AND NEED FORAGENCY ACTION
In the PEIS, APHIS identified a purpose and need to respond to the Enlist petitions for determinations ofnonregulated status for the three GE events in accordance with its current regulatory authority. As required by7 CPR 340.6, APHIS must respond to petitioners that request a determination ofthe regulated status ofGE organisms, including GE plants such as Enlist com and soybean, and must make a determination on whether the GE organism is likelyto pose a plantpest risk. IfAPHIS determines, based on its PPRA, that the GE organism is unlikely to pose a plantpestrisk, 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 pestprovisions ofthe Plant Protection Act of2000 and 7 CPRpart 340. In summary, the purpose and need ofthis project is to make a decision on these petitions that is consistent with its regulatoryrequirements in 7 CPRpart 340.
PLANT PEST RISK ASSESSMENT The PPRA characterizes the potential plant pestrisks associated with the GE product (crop) that is the subject ofthe petition for nonregulated status relative to its conventional varieties. Itis based on information supplied in the petition for determination ofnonregulated status together with otherrelevant publically available scientific data. APHIS concluded from its PPRAs that DAS-40278-9 com, DAS-68416-4 soybean, and DAS44406-6 soybean are unlikelyto pose a plantpestrisk. APHIS found no evidence ofEnlist com and soybean posing plant pestrisks or otherrisks based on the following reasons: (1) No plantpestrisk was identified from the transformedprocess, the insertion and/or expression ofnew genetic material, or from changes inmetabolism in DAS-40278-9 com, DAS68416-4 soybean, and DAS-44406-6 soybean.

5 The FEIS canbe viewed at http://www.aphis.usda.gov/brs/aphisdocs/24d_feis.pdfor under docket number APHIS2013-0042 atregulations.gov.
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(2) Disease and pest incidence and/or damage were not observed to be significantlyincreased 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 expectedbased on these or other agricultural products. (3) Based on an evaluation ofthe gene products (AAD-1 protein inDAS-40278-9 com; AAD-12 and PATproteins inDAS-68416-4 soybean; AAD-12, PAT, and 2mEPSPS in DAS-44406-6 soybean) and agronomic and compositional data, exposure to and/or consumption ofEnlist 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 likelyto become weedier ormore difficult to control as a weed than conventional varieties ofthese crops based ontheir observed agronomic characteristics, the weediness potential ofthe 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 ofother species with which they can interbreed in the United States orits territories. Gene flow, hybridization and/or introgression ofinserted genes from Enlist com and soybean to other sexually compatible relatives with which they can interbreed is not likelyto occur. (6) Major changes in agricultural or cultivation practices associated with the adoption ofDAS40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 soybean are not expected with the exception ofthose associated with the use orthe timing ofapplications ofcertain phenoxy-auxin herbicides and ACCase inhibitor "fop" herbicides (pending EPA approval). These changes are not likelyto increase plant diseases orpests or compromise their management. (7) Horizontal gene transfer ofthe new genetic material inserted into Enlist com and soybean to other organisms is highlyunlikely, and is not expected to lead directly orindirectlyto disease, damage, injury orharm to plants, including the creation ofnew ormore virulent pests, pathogens, orparasitic plants. FINAL ENVIRONMENTAL IMPACT STATEMENT APHIS prepared an FEIS to examine the potential impacts onthe human environment from determinations ofnonregulated status ofDAS-40278-9 com, DAS-68416-4 soybean, and DAS44406-6 soybean6

. APHIS evaluated potential impacts inthe FEIS associated with the decision to approve the three petitions requesting a determination ofnonregulated status for each ofthe three Enlist events. A summary ofthe analyses contained in the FEIS is set forth below, inthe

6 The FEIS canbe viewed at http://www.aphis.usda.gov/brs/aphisdocs/24d feis.pdforunder docket number APHIS2013-0042 at regulations.gov.
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section entitled "Environmental Consequences Associated with the Determinations of Nonregulated Status under Alternative 2." 

### Alternatives Considered in the FEIS 

### Alternative 1: NoActionAlternative- Continuation as aRegulatedArticle UndertheNo Action Alternative, APHIS would denythe 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 CFRpart 340. Notifications orpermits with conditions specifiedbyAPHIS would berequired to move viable plant material and to plant it outdoors. 

### Alternative 2: Deregulation ofDAS-40278-9 Corn, DAS-68416-4 Soybean, andDAS-44406-6 Soybean Under Alternative 2, ifEnlist com and soybean varieties were determined unlikely to pose a plantpest risk and all three Enlist events received nonregulated status, the Enlist com and soybean varieties and progeny derived from them would no longerberegulated articles under the regulations at 7 CFRpart 340. APHIS Biotechnology Regulatory Service (BRS) permits or notifications would no longerberequired for introductions ofcom and soybean derived from the Enlist com and soybean varieties. 

### Alternative3: Deregulation ofDAS-40278-9 Corn, Only Under Alternative 3, onlyDAS-40278-9 com and progenyderived from its cultivation would be granted nonregulated status and no longerbe subject to the regulations at 7 CFRpart 340. DAS68416-4 and DAS-44406-6 soybean would continue to beregulated 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 pestrisk to agricultural crops or other plants inthe United States. Therefore, choosing this alternative would be inconsistent with the purpose andneed ofthe projectbecause it is inconsistent with the scientific evidencebefore APHIS regarding plantpestrisk. 

### Alternative 4: Deregulation of DAS-68416-4Soybean andDAS-44406-6Soybean, Only Under Alternative 4, onlyDAS-68416-4 and DAS-44406-6 soybean and progeny derived from their cultivation wouldbe granted nonregulated status and no longerbe subject to the regulations at 7 CFRpart 340. DAS-40278-9 com would continue to beregulated as described under Alternative 1. APHIS would no longer require BRS permits or notifications for introductions of Enlist soybean and progenyderived from these events. APHIS made the determination that Enlist com and soybean varieties are unlikely to pose a plant pestrisk to agricultural crops or otherplants in the United States. Therefore, choosing this alternative would be inconsistent with the purpose and need ofthe project because it is inconsistent with the scientific evidence before APHIS regardingplant pest risk.

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### Major Issues Addressed in 

### the FEIS The FEIS described the four alternatives considered and assessed the potential impacts ofthe deregulation ofEnlist crops on the human environment. APHIS sought input from member ofthe public on issues and alternatives the Agency should consider inpreparation ofthe EIS related to determinations ofnonregulated status ofDAS-40278-9 com, DAS-68416-4 soybean, and DAS44406-6 soybean. Theresource areas considered inthe FEIS were developed basedupon the relevant concerns and issues identified in the Notice ofIntent to prepare an EIS that APHIS published inthe Federal Register on May 16, 2013. The following resource areas were assessed and evaluatedbyAPHIS inthe FEIS:

• Food and Feed Safety • Worker Safety • Animal and Plant Communities • Socioeconomic Impacts o Domestic Use ofCom and Soybeans o Export ofCom and Soybean • Agronomic Inputs and Cost ofProduction • Land Use • Physical Environment o Surface and Ground Water Quality o Air Quality and Climate Change
The scope ofthis EIS covered the direct and indirect impacts that would result from the cultivation and use ofEnlist com and soybean. The EPA, in its registration process, is considering any direct and indirect impacts from herbicide use on Enlist crops7• Additionally, APHIS considered the FDAregulatory assessment in making its evaluation ofthe potential impacts ofa determination ofnonregulated status ofEnlist 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 onthe Enlist crops to be complete8• 

### PUBLIC COMMENTS RECEIVED ON THE FEIS OnAugust 8, 2014, APHIS published the FEIS for its determinations onpetitions for nonregulated status ofDAS-40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 soybean. During the 30-day "reviewperiod" required underNEPA, 40 CFR §1506.1O(b)(2), APHIS received comments from the public on the FEIS. This 30-dayreview period closed on September

7 The EPA docket for evaluation of2,4-D choline salt herbicide onEnlist com and soybeans (EPA-HQ-OPP-2014- 0 195) canbe accessed atregulations.gov at this web address: http:/ /www.regulations.gov/#!docketDetail;D=EPAHQ-OPP-2014-0195. 8 Completed FDA consultations (BiotechnologyNotes 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) canbe accessed at FDA's website: http://www.accessdata.fda.gov/scripts/fdcc/?set=Biocon.
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8, 2014. APHIS received 969 total submissions. The majority ofthe 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 ofderegulation. Three submissions from nongovernment organizations contained a total of240,670 signatures opposing the deregulation of Enlist crops. These submissions did notraise any new substantive issues with regard to the FEIS. These submissions expressed general concerns relating to pesticide use, GE plants, orDAS40278-9 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 inthe evolution of2,4-D-resistant weeds ormultiple herbicide-resistant weeds, leading to the abandonment ofconservation tillage practices which inevitablywould increase soil erosion. However, such concerns and issues were previously assessed and addressed inthe text and appendices ofthe FEIS. 

### HERBICIDE USE APHIS has no statutory authority to authorize orregulate the use of2,4-D, glufosinate, quizalofop, glyphosate, or any other herbicide, by growers. Under APHIS' current part 340 regulations, APHIS onlyhas 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 itmaypose a plantpestrisk. Anydirect and indirect impacts associated with the expected increased use of 2,4-D or otherherbicides on Enlist com and soybean are outside the scope ofthis EIS because the authority to regulate the impacts ofherbicide useresides 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 beregistered, a pesticide mustbe able to beused without posingunreasonable risks to people orthe environment. The EPAhas conducted independent assessments ofdirect and indirect effects associated with the use of2,4-D onEnlist com and soybean and is making an independent action to determine whether to approve registration ofthe 2,4-D and glyphosate premix, Enlist Duo9• The EPAhas also conducted assessments for the new use ofquizalofop on DAS-40278-9 com as part ofthe 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 petitionrequests for determinations of nonregulated status ofDAS-40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 soybean. This Record ofDecision onthe FEIS is based on APHIS' full and complete review and consideration ofall ofthe scientific and environmental data, analyses, information, and conclusions ofthe PPRAs; the FEIS; the public comments onthe DEIS; the agency's response to comments on the DEIS; and comments onthe FEIS.

9 The EPA docket for evaluation of2,4-D choline salt herbicide on Enlist com and soybeans (EPA-HQ-OPP-2014- 0195) can be accessed atregulations.gov at this web address: http:/ /www.regulations.gov/#!docketDetail;D=EPAHQ-OPP-2014-0195.

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APHIS is selecting Alternative 2 ofthe 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 regulatoryrequirements in 7 CFRpart 340. APHIS mustrespond to petitioners that request a determination ofthe 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 ifthe GE organism is unlikelyto pose a plant pestrisk. If APHIS concludes, based on its PPRA, that the GE organism is unlikely to pose a plant pestrisk, APHIS must then issue a determination ofnon-regulated status, since the agency does not have statutory authority to regulate GE organisms that are not plant pests. According to the PPRAs published onAugust 8, 2014, APHIS concluded that the Enlist corn and soybean events are unlikelyto pose a plantpestrisk. APHIS has therefore concluded that the selection ofAlternative 2 in this Record ofDecision is consistent with the plant pest provisions ofthe Plant Protection Act of2000, the regulations codified at 7 CFRpart 340, and thebiotechnologyregulatory policies in the Coordinated Framework.

• APHIS reviewed the conclusions it reached in the FEIS onthe environmental consequences ofAlternative 2 and, in light ofthose conclusions, as well as those ofthe final PPRA, APHIS finds that Alternative 2 best serves the purpose and need for agency action as identified inthe FEIS, as well as being in accord with APHIS' regulatory authority under 7 CFR 340. The environmental consequences ofAlternative 2 are discussed inthe next section. ENVIRONMENTAL CONSEQUENCES ASSOCIATED WITH THE DETERMINATIONS OF NONREGULATED STATUS UNDERALTERNATIVE 2 The following is a summary ofthe conclusions APHIS reached on the environmental consequences ofAlternative 2. UnderAlternative 2, Enlist corn and soybean couldbeplanted, but no newherbicide uses, such as 2,4-D or quizalofop, would be allowed on these varieties. EPAregulates the use ofherbicides 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 havebeen shown to be compositionally similar to currently available varieties ofcorn 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 onthe characterization, composition, allergenicity, and toxicity ofthe proteins inserted in DAS40278-9 corn, DAS-68416-4 soybean, and DAS-44406-6 soybean. The FDA evaluated the information inDow's submissions to ensure that regulatory and safetyissues 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 10Record ofDecision

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 inthe United States. The FDA did notidentify 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 likelyto be any effects associated with consumption offood and feed containing Enlist com and soybean when compared to the No Action Alternative.

• The AAD-1 protein in DAS-40278-9 comis derived from the common gram-negative soil bacterium Sphingobium herbicidovorans (Herman etal., 2010) 10• Sphingobium is a member ofthe sphingomonads, a widely distributed bacteria group isolated from soil and water as well as plantroot systems (DAS, 2009; DAS, 201Ob). The sphingomonads have beenused widely inbiotechnology applications, includingbioremediation of environmental contaminations as well as production ofsphingans, bio-based polymers which are usedinthe 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 offood and feed containing the AAD-1 protein inDAS-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 bacteriumDelftia acidovorans. D. acidovorans is non glucose-fermenting, gram-negative, non-spore-forming rod typebacteriumpresent in soil, fresh water, activated sludge, and clinical specimens. It has a history ofsafe use in the food processing industry, including having beenused in transforming ferulic acid into vanillin and related flavor metabolites (DAS, 2010a). Because the AAD-12 protein has a safe history ofuse in food processing, under the Alternative 2, there are not likely to be any effects onhumans or animals consuming food and feed, respectively, from Enlist soybean when compared to the No Action Alternative.

• Thepatgene is derived from Streptomyces viridochromogenes, a gram-positive soil bacterium. Thepat gene conveys resistance to glufosinate (Wohlleben etal., 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 etal., 2001; USDA-FAS, 2004; USDA-ERS, 2005; Duke and Powles, 2008). Additionally, FDAhas previouslyreviewed submissions regarding the safety offood and feed derived from crops containing thepat gene (BiotechnologyNotification Files (BNFs) 000055, 000073, 000081, 000085, and 000092). Becausethe PAT protein expressed in DAS-68416-4 and DAS-44406-6 soybeanhas alreadybeen evaluated byFDA and soybean (and other crops) containing thepatgene are already in commerce, there are not likelyto be any effects onhumans and animals consuming food and feed, respectively, from Enlist soybean when compared to the No Action Alternative.

1

## °

Citations for references maybe found in the FEIS.
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Record ofDecision

• The 

### mepsps gene in DAS-44406-6 is derived from 

### Zea mays, com. It contains two mutations which conveyresistance 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 comwhich have been deregulated byAPHIS. GA21 com (BNF 51), GHB614 cotton (BNF 1 09), and HCEM485 com (BNF 106) have completed consultations with FDA. Because ofthe similarity ofthe EPSPS protein expressed in DAS-44406-6 and the com and cotton varieties noted above, under the Alternative 2, there are not likelyto be any effects onhumans 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 orindirect effects onworker safetythat 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 inthe cultivation ofcom and soybean. Potential hazards to workers associated with the various agronomic managementpractices used to grow com and soybean would bethe 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 EPAregulates the use ofherbicides under FIFRA and considers the effects onhumanhealth when approving the use ofherbicides. The EPA, in its registrationprocess, is considering any direct and indirect impacts from the newuse ofherbicides on Enlist crops. Biological Resources AnimalCommunities

• Animals found in the vicinity ofagricultural fields ofDAS-40278-9 com, DAS-68416-4 soybean, orDAS-44406-6 soybean would continue to feed on com and soybean inthese fields. These com and soybean varieties havebeen 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 ofcom, 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 safetyissues regarding human food and animal feed derived from the new plant varieties havebeenresolved prior to commercial distribution. No potential impacts to animal communities from consumption and exposure to Enlist com and soybean are anticipated underthe Alternative 2 in comparison to the No Action Alternative.

• Animals can also be impacted indirectlyby 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 intillage to control weeds can increase soil erosion and indirectlyimpact wildlife. Agricultural production ofcom and soybean would continue to use currently EPA-registered pesticides for weed management. The environmental risks ofpesticide use on wildlife Page 12Record ofDecision

and wildlife habitat are assessed by EPA inthe pesticideregistration process and are regularlyreevaluated byEPA for each pesticide to maintain its registered status under FIFRA. 

### Plant Communities

• Under Alternative 2, the direct and indirect effects ofapproving these three petitions on plant communities would be similar to the effects onplants 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 ofcom 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 managementpractices. 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 inproduction fields, resulting in establishment ofnovel 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 inAlternative 2, does not in any manner authorize or approve anyherbicide use onthese com or soybean varieties. APHIS has no regulatory authority over the use and application ofherbicides or pesticides. EPAregulates the use ofherbicides under FIFRA and is making a separate decision onthe new uses ofherbicides on these plants. Therefore, there are no changes to the potential effects to plant communities under Alternative 2 when compared to theNo Action Alternative. Socioeconomics

• Enlist com and soybean havebeen shown to be compositionally similar to currently available varieties ofcom 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 orindirect effects associated with the cultivation ofthese events on the domestic use of com and soybean.

• As with the No Action Alternative, under Alternative 2, growers ofspecialty value added com and soy crops, including organic com and soybean, would see production and demand for these value added crops unchanged bynonregulated status ofthe Enlist crops.

• Dowhas submitted applications to various international regulatory authorities for food, feed, and/or cultivation approvals. Approvals for one or more ofthe 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 majorbarriers inthe trade ofGE 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 Page 13Record ofDecision
adversely affecting current trade flows. In some export markets where Enlist com or soybean are not approved from import or for non-geneticallymodified, identity-preserved com or com flour shipments, testing for thepresence ofEnlist com or soybean maybe required. Ifa new type oftest would beneeded for Enlist com and soybean, current testing costs mayincrease by 10 to 15 percent. 

### Land Use and PhysicalEnvironment

• Land use for com and soybeanproduction is drivenbythe price ofcom and soybean, as well as the suitability ofthe land for production ofthese crops. As a result, the availability ofEnlist com and soybean would not have any direct orindirect effects on land use under Alternative 2 in comparison to the No Action Alternative.

• Under Alternative 2, growers ofspecialtyvalue added com and soybean crops would see production and demand for these value added crops unchanged bynonregulated 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 underthe 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 orindirectly affect grower decisions to use tillage orherbicides to manage weeds. Under Alternative 2, Enlist com and soybean couldbeplanted but no new herbicide uses would be allowed onthese varieties. EPA regulates the use ofherbicides under FIFRA and is making a separate decision on the use of2,4-D onthese plants. 

### Threatened and Endangered Species APHIS, as described below, evaluated thepotential effects that the three determinations of nonregulated status ofDAS-40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 soybean mayhave, ifany, on federally-listed threatened and endangered species (TES) and species proposed for listing, as well as designated critical habitat and habitat proposed for designation.
Forits analysis ofpotential effects on TES plants and critical habitat, APHIS focused onthe 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. Forits analysis ofpotential effects on TES species, APHIS focused onthe implications ofexposure ofthe novel proteins expressed inthe plants as a result ofthe transformation, and the ability ofthe 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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• Based on a lack ofweediness in Enlist com and soybean, APHIS concluded that availability ofEnlist com and soybean would not extend the range ofcom and soybean production or lead to cultivation on land not previouslyused for agricultural production.

• APHIS considered as part ofthe analysis forTES and critical habitat ifthe new phenotype imparted to Enlist com and soybean may allow the plant to naturalize inthe environment and potentiallyhave an effect on TES. No differences were detected between Enlist com and soybean and conventional varieties in growth, reproduction, or interactions withpests and diseases, other than the intended effect ofherbicide tolerance. Based on agronomic field data and a survey ofscientific literature on weediness potential, the inserted genes do not alter weediness potential ofEnlist com and soybean, and thus these varieties are unlikely to affect TES or critical habitat as troublesome orinvasive weeds.

• After reviewing the list ofthreatened and endangered plant species orplants 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 ofthese listed plants are in the same genus nor are known to cross pollinate with species ofthe 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 byDow included evaluations ofthe protein structure and function ofEnlist com and soybean, including homology searches ofthe amino acid sequences with comparison to all known allergens and toxins, and in vitro digestibility assay ofthe proteins, and acute oral toxicity feeding study inmice, 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 ofEnlist com or soybeanbyany 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 mayuse the com or soybean plant to complete its lifecycle ). A review ofthe 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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ENVIRONMENTAL ALTERNATIVE The environmental alternative is not onlythe alternative that causes the least harm to the biological and physical environment, but also the alternative which bestprotects, preserves, and enhances historic, cultural, and natural resources. APHIS analyzed the impacts offour alternatives onthe human environment in detail in the FEIS. Becausethere is no difference in the potential impacts among the alternatives when compared to the No Action Alternative, APHIS has not identified an EnvironmentallyPreferred Alternative as per40 CFR 1505.2(b).
UnderAlternatives 2, no direct orindirect 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 inthe No Action Alternative, because these GE varieties are not agronomically different from non-GE com and soybeanplants orother GE com or soybean plants that are no longer regulated bythe Agency. APHIS determined that the deregulation and commercial availability ofEnlist com and soybean varieties would not result in an increase in com and soybean acreage in areas already in
com and soybean production orresult in changes inwhere com and soybean are currently grown. In addition, these three GE plant varieties would not affect natural (e.g., soil, water, air, and climate) orbiological (e.g., animal, insect, plant) resources any differently than those com and soybean varieties currently grown under the No Action Alternative.
The continued emergence ofglyphosate-resistant weeds under theNo Action Alternative will itselfcall for modifications ofagronomic management practices to address these weeds. Growers will likely continue to use glyphosate because it is still effective onhundreds ofweed species, but will become less reliant on glyphosate for the control ofweeds 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 bythe agronomic management practices growers choose to adopt.
Under Alternative 2, as with theNo ActionAlternative, 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 applyherbicides 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 onthese com or soybean events until EPA approves the label. Therefore, herbicide-resistant weeds would be selected for by agronomic management practices inthe same ways that they are inthe 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 agencyresponsible for the analysis ofthese impacts. The EPAhas thoroughly analyzed the potential impacts ofproposed new uses ofEnlist Duo as part of theirpesticide registration process. The expected increased use of2,4-D on DAS-40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 soybean has thepotential 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 ofEnlist com and soybean plants themselves. Measures EPA is proposing to include on the Enlist Duo label addressing this potential development ofresistant weeds are discussed in

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the following section discussing mitigations ofimpacts. Weed scientists will continue to encourage growers to use bestmanagement 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 ofthese three events (DAS-40278-9 com, DAS-68416-4 soybean, and DAS-44406-6 soybean), either individually ortogether, would have different effects on the human environment than the No Action Alternative. Therefore, approving the petition for deregulation ofEnlist comunder Alternative 3 or Enlist soybean under Alternative 4 is also not expected to have different direct and indirect effects onresource areas in comparison to the No Action Alternative. Because there is no difference in thepotential impacts among the alternatives, there is no environmentallypreferable alternative. MITIGATIONS OF IMPACTS ASSOCIATED WITH ALTERNATIVE 2
In an analysis ofCumulative Impacts, the independent actionbyEPA 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 ofEnlist 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 ofweeds resistant to that herbicide. APHIS also acknowledges that the availability ofdicamba-resistant soybean (called Xtend soybean) varieties onthe market is reasonably foreseeable. The EPA is conducting independent assessments ofdirect and indirect effects associated with the use ofdicamba onXtend soybean to determine whether to approve this new dicamba registration. Itis reasonable foreseeable that EPA will approve the registration ofthe new use ofdicamba on Xtend soybean, although the details ofthe registration are not known at this time. The potential increased use ofdicamba associated with growing ofXtend soybean is expected to increase selectionpressure ofdicamba-resistant weeds ifthe herbicide is used withoutrotating to otherherbicides. Dicamba and 2,4-D are both synthetic auxins with very similarherbicide chemistries, however they are not likely to beused simultaneously. Cultivation ofherbicide-resistant crops is not the cause ofherbicide-resistant weeds, butresults from the failure ofgrowers to applybest management practices inthe production ofherbicide-resistant crops. Growers maymitigate the rate at which weeds develop resistancebythe agronomic practices they choose. The impact ofincreased 2,4-D or dicambause on the selection of2,4-D- or dicamba- resistant weeds maybemitigated byuse ofbest management practices. Some examples ofthe practices that can be followed to reduce or delaythe selection ofherbicide-resistant weeds include, rotating crops, rotating types ofherbicides, 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 ofa threat to agricultural production than resistance to other critical herbicides, and the likelihood that it will be used in a manner consistent withbest management practices is good. Farmers are aware oftheproblems ofresistant weedbiotypes and are increasinglyproactive in the identification and removal ofnew weeds. Societies such as the Weed Science Society ofAmerica, university extension agents, and industry, have made a concerted effort to increase grower awareness ofbest management practices for herbicideresistant weeds.

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When considering cumulative impacts for Alternative 2, 2,4-D use is expected to increase ifEPA approves the amended use of2,4-D onthe Enlist crops. However, increases in other herbicide sites ofaction under Alternative 2 are expected to be less than under the No Action Alternative because the Enlist Duo herbicide are expected to bepreferentially adopted ifapproved for use on these crops by EPA. The availability ofinexpensive and effective herbicides in Enlist Duo combined with Enlistcom and soybean may delay the adoption ofnon-chemical management strategies. Fewer growers would be expected to adopt aggressive tillage when herbicides remain effective for weed control. Selection ofweeds resistant to glyphosate and non-glyphosate herbicides will still occur. The selectionpressure for herbicide-resistant weeds will depend on the agronomic management practices employed under each alternative and cannotbepredicted. More diversified weed management practices will result in less selective pressure for resistance to any givenherbicide ormanagement technique.
APHIS does not have the authority to regulate grower managementpractices. Further, APHIS has no authority to regulate herbicide use orto impose anymitigation measures with regard to the use ofanyherbicides, including 2,4-D. Under FIFRA, the EPA registers pesticides and prescribes the conditions for use ofthepesticide. The EPA must ensure that the pesticide, when used according to label directions, will not cause unreasonable adverse effects to human health orthe environment. Mitigationmeasures to oversee the proper usage ofherbicides are determined bythe EPA and specified onthe EPA-approved pesticide labels. Applyingpesticides in a waythat is inconsistent with the label is illegal. Recognizing the increasing economic issues resulting from herbicide-resistant weeds, the EPA is includingmeasures to address weed resistance as part ofthe registration terms for Enlist Duo11 • Bestmanagement practices for helpingprevent the development ofresistant weeds will appear onthe Enlist Duo label, including: rotating herbicide chemistries, limiting herbicide applications per season; scouting fields bothbefore 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 promoteresistance management efforts, with an overall goal to assist and support responsible use ofthe product. The program mandates that Dowmust immediately investigate any claims ofnon-performance and take immediate action to eradicate weeds identified as likelyresistant weeds. Additionally, the stewardship program also includes educating and training retailers, farmers, and applicators onthe appropriate use ofEnlist technology, reporting verified cases ofresistance to Enlist Duo to interested parties, developing diagnostic testing for evaluatingresistant weed species, and monitoring whether Enlist Duo is beingused on Enlist seed.
EPA has determined that the registration must contain a term that requires DAS to submit annual summaryreports to EPA that include a summary ofthe number ofinstances oflikely and confirmed weed resistance byweed species, crop, county and state. EPA believes that it is

11 EPA's registration decision, including daft label, risk assessments, and analyses, onthe registration ofEnlist Duo canbe accessed at regulations.gov at this web address: http:/ /www.regulations.gov/#!docketDetail;D=EPA-HQOPP-2014-0195.

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important to address likely weed resistance and not wait until confirmation ofresistance has been found. Becausethe issue ofweed resistance is an extremelyimportant issue to keep under control and canbe very fast moving, EPAhas determined that the registration must contain terms that ensure that EPAretains 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 ofherbicide resistance and help control the spread ofherbicide-resistant weeds from field to field. The likelihood ofsuccess will depend on the extent to which growers rely exclusively on Enlist Duo versus employing a range ofother management techniques. Because oflossesrecently experienced with glyphosate-resistant weeds, growers maybemore motivated to employbestmanagementpractices. 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 ofnonregulated 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 commentperiod 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 ofthe three Enlist events. APHIS has accepted that noxious weed petition pursuant to 7 CFR 360.500, "Petitions to Add a Taxon to theNoxious 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 separatelypursuant to those regulations. APHIS, in its Response to Comments section ofthe 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 ofnonregulated status ofa GE organism is evaluated pursuant to APHIS' 7 CFRpart 340 regulations, and pursuant to that regulation, APHIS makes such a determination onthe basis ofwhether the GE organism is likelyto pose a plant pestrisk. On the other hand, a petition to list some organism as a noxious weed is evaluated under APHIS' 7 CFRpart 360 regulations, and pursuant to those regulations, APHIS makes a determinationonthebasis ofwhether 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

## 7CFRpart 340 and 7 CFRpart 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 wouldbe evaluated separately. APHIS has also sent the commenter a letter acknowledging its request. APHIS will evaluate the commenter's noxious weed petitionbased on an analysis ofavailable scientific data, a weed risk assessment, and other available information; and when such evaluation is complete will inform the petitioner and the public oftheir decision on the noxious weed petition.

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Record ofDecision

COMPLIANCE WITH APPLICABLE LAWS, EXECUTIVE ORDERS, AND REGULATIONS This Record ofDecisionhas beenprepared in accordance with: (1) the National Environmental Policy Act (NEPA), (2) regulations ofthe Council on Environmental Quality for implementing the procedural provisions ofNEP A (40 CPRparts 1500-1508), (3) USDA regulations implementing NEPA (7 CPRpart 1 b), and (4) APHIS' NEPA Implementing Procedures (7 CPR part 372).
The Record ofDecision considered the directives ofExecutive Order (EO) 12898 (US-NARA, 2008), "Federal Actions to Address Environmental Justice in Minority Populations and LowIncome Populations;" EO 13045, "Protection ofChildren from Environmental Health Risks and Safety Risks;" EO 13112 "Invasive Species;" EO 13186, "Responsibilities ofFederal Agencies to Protect Migratory Birds;" and EO 12114, "Environmental Effects Abroad ofMajorFederal Actions."
The Record ofDecision was determined to be compliant with otherFederal 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 ofAgriculture

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