### July29, 20IO Michael C. Gregoire DeputyAdministrator BioteclmologyRegulatory Services Animal andPlant Health Inspection Service U.S. DepartmentofAgriculture 4700 RiverRoad, Unit98 Riverdale, MD 20737 Re: Petition03-323-0IpforNon-Regulated Status, Roundup ReadV® Sugarbeet-I; EventH7 SupplemcntalRegucst for "PartialDeregulation" orSimilarAdministrativeAction DearMr. Gregoire: Monsanto Company("Monsanto") and KWS SAATAG ("KWS")jointlyfiled thepetition fornonregulatedstatus forRoundup Ready sugarbeet' EventH7-1 ("RRSB") whichUSDA's Animal and PlantHealth Inspection Service ("APHIS")previously granted in March2005. In light ofrecentdevelopments in litigation, and withthe supportofthousands of sugarbeet growers nationwide and all sugarbeetcooperatives,processors and seed-producers, Monsanto and KWS jointlysubmitthis supplemental request for "partialderegulation" orsimilaradministrative action, as set forth below. Background OnMarch 17,2005,APHIS granted nonregulated status for RRSB following nearly 100 field trials, a60-daycommentperiod and issuance ofan environmental assessment ("EA") concludingthatthe eventpresented "nosignificantimpact onthe human environment." Inthe years thereafter, amajorityofournation's sugarbeetgrowers apopted RRSB; wide-scale RRSB seedproductionbeganby2006, andthemulti-yearprocessto develop appropriate RRSB varieties forgrowers in IO states resulted inRRSB cultivation on roughly95% ofall U.S. sugarbeet acreage. TheGovernrnentofCanadalikewise approved RRSB forcultivation and human and animal consumption, and the European Union, Japan, Mexico, South Korea, Australia,New Zealand, China, Colombia, Russia, Singapore, and thePhilippines each approved impOltationof sugarand otherproducts derived from RRSB. Today, RRSB is processedintoroughlyhalfofour nation's domestic sugarsupply.

, ® Roundup and Roundup Readyareregistered trademarks ofMonsantoTechnologyLLC.

### On September21, 2009, however, a Federal district COUlt in San FranciscolUled that APHIS's2005 EAfor RRSB did not adequatelyevaluatepotential cross-pollinationfrom RRSB seed crops to othercrops. TheCOUltheldthatAPHIS "didnotconsiderthe effects ofgene transmission on conventional farmers and consumers ofsugarbeetseed orofgene transmission to therelated cropsofred table beets and Swiss chard" and notedthatsuch "seedproductiontakes placeprimarilyin theWillametteValley ofOregon." 

### Cellter forFoodSafety v. Vilsack ("CFS''), No. 08-484, 2009 WL 3047227, *5, 13-14(N.D. Cal. Sept. 21, 2009). Thatlitigation is currently in theremediesphase, wheretheplaintiffsin the suithave soughtajudicialorderhalting further plantingofRRSB. Representatives ofthe thousandsofsugarbeet growers nationwide along with sugarbeetcooperatives and processors, the seed companies whoproduceRRSB seed and Monsanto haveintervenedinthis suit to urgethe courtnotto haltongoing orfuture RRSB cultivation. Specifically, thedistrict courthas beenpresented with evidencethat an orderimmediatelyhalting RRSB plantingwouldhaveprofound consequencesforthe nation's growers and manyother parties, includingthat:

• F81ming communities could suffer losses exceeding$2billion;
• Approximately eight sugarbeetprocessingfacilities would close (likelyforever);
• Morethan 5,500jobs wouldbelost; and

• Theresultingdomestic sugarshortages would, underUSDA estimates, cost consumers $2.972billion in 20II alone. Recently, theSupreme COUlthas addressed deregulation ofa similarcrop, Roundup Ready alfalfa, andprovided significantguidance applicablehere. 

### SeeMonsanto Co. v. 

### Geer/sonSeed Farms, No. 09-475,

-- S. Ct. --, 2010WL2471057 (2010). TheSupremeCourt concludedthat, even where aCOUIthasheldthatAPHIS has violated NEPAwithrespectto acomplete deregulationdetennination,"[a]tthatpoint, it

### was forthe agency [APHIS] to decidewhetherand to whatextentitwouldpursue

### apartialderegulation." 

### Id. at *13. "If

... alimited and temporary deregulation satisfied applicable statutoryandregulatoryrequirements, itcouldproceed withsuch aderegulationeven ifit hadnotyet finished (heonerousElS required forcompletederegulation." 

### !d. TheSupreme Courtwentonto identifyacombination ofgeogl'aphic restrictions, isolation distances, and enforcementmeasures tllat could serve to eliminate anyrisk of"injuryat all, much less irreparableinjUly." 

### Id. at *15. In lightofthisrecent Supreme CourtlUling, the Govemmenthas represented to the district courtin San Francisco that, inthe event the comtvacates the existingRRSB deregulation, APHIS has authorityto deregulate "inpart"to "allowplantingto occurunderthe conditionsproposedby APHIS whiletheEIS is beingprepared." As APHIS explained, itcould take such action if "[i]ntervenors submitted anewpetition 01'

### a supplement 01' 

### amendmentto apreviouspetitionfor a determination ofnonregulated status ofRRSB." Federal Defs.' Supp. Br. onPenn. Inj. Reliefat I, 13-14. TheGovernmen( furtherexplainedthat the Supreme Court'sdecision in 

### "Monsanto clearly indicatesthatthis typeofintelim administrative action would be permissible." 

### !d. at 14; 

### see also Monsanto, 2010WL 2471057, at *15 (citing "representationfrom the SolicitorGeneral"that APHIShas authorityto do so). Separ'ately, based onits expCltanalyses and review, APHIS has proposedtothedistrict eomia series ofcarefullytailored interim measures designed to address any potentialriskofharm to otherpmties from continued cultivation ofRRSB duringthetimeperiod necessaryfor APHIS to reevaluatethe RRSB petitionfor nonregulated status. Althoughtherehas beenno record ofanyharm to any growerofany othercropsinthe multipleyears ofwide-scale RRSBproduction withouttheserestrictions inplace, the intervenors in this litigationhave agreed that these additional interimrequirements will reduce further an alreadynegligiblepotential for anyimpactto otherparties from RRSB.

2RequestforInterimMeasures With the supportofeach ofthe sugarbeel growers, cooperatives,processors and seed companieswho have intervened inthependingRRSB litigation,Monsanto andKWS nowjointly requestthat, intheeventthecourtintheRRSB litigationvacatestheexistingderegulation determination,APHIS grant nonregulated status illpariortake similaradministrativeaction to authorizecontinuedcultivationoftheRRSB crop subjectto Ihe carefullytailoredinterimmeasures proposedbyAPHIS. Petitionersbelievethisrequestis appropriate inthiscontexthecause: (1)AsAPHIS explainedits recent SupplementalBrief, theU.S. SupremeCourthas clarified thatAPHIShas authorityto implementinterimmeasures throughpaltial deregulation or similarmeans forthispurpose; (2) Sugarbeet growersnationwide, alongwithsugarbeetcooperatives,processors, seed companies andotherinterests,face significantharmfrom anyhaltin RRSB planting, cultivation, harvestingorprocessing; and (3) Petitioners arerequestingthatAPHIS implementmeasuresthat APHIS has already itselfreviewed, analyzed and supported in thelitigationcontext. Attachedtothis letteris an EnvironmentalReport,providingadditional analysis ofthe proposedinterimmeasures. Theanalysis inAPHIS's Oliginal EAaddressingMonsanto and KWS'spetition, alongwiththeSOOO-page administrativerecord relatingthereto and this Environmental Report all supportpetitioners' requestforpartial deregulationorsimilar administrative action. Thankyouverymuch foryourattentionto this matter.
Sincerely,

H. KeithReding, Ph.D. RegulatoryAffairs Manag

3ussche Executive Board ofKWS SAATAG

Dr. PeterHofmann Head ofSugarBeet Division

4

### ENVIRONMENTAL REPORT Interim Measures for Cultivation of Roundup Ready® Sugar Beet Event H7-1

July 30, 2010ACCase a.e. ALS AMS AP APHIS APM ARS ASTA BNF BRS CEQ CFIA CFR CFS CMS cPAD CTIC DEIS DNA EA EC EEC EFSA EIQ EIS EPA EPSPS ER ERS EU FDA FFDCA FIFRA

Event H7-1 Draft ER 

### ACRONYMS AND ABBREVIATIONS acetyl-CoA carboxylase (enzyme) acid equivalent acetolactate synthase (enzyme) Agricultural Marketing Service (USDA) Adventitious presence Animal and Plant Health Inspection Service (USDA) American Public Media Agricultural Research Service (ARS) American Seed TradeAssociation Biotechnology Notification Files Biotechnology Regulatory Service (USDA APHIS) Council on Environmental Quality Canadian Food Inspection Agency Code of Federal Regulations Centerfor Food Safety cytoplasmic male sterility chronic Population Adjusted Dose Conservation Technology Information Center Draft Environmental Impact Statement DeoxyribonucleicAcid Environmental Assessment European Commission (EU) Estimated Environmental Concentration European Food Safety Authority Environmental Impact Quotient Environmental Impact Statement Environmental Protection Agency (US) 5-enolpyruvylshikimate-3-phosphate synthase (enzyme) Environmental Report Economic Research Service (USDA) European Union Food and Drug Administration (US) Federal Food, Drug, and Cosmetic Act Federal Insecticide, Fungicide, and Rodenticide Act Acronyms 7/28/2010FONSI FQPA FSA FSANZ ft GE GM GMO GPS GR GT HQ HTS 1M/NRC IPM IPA ISF NASS NEPA NOAEL NOP NRC OECD OP OSTP PCR PHI PNT POEA PPA PPE PPI rDNA RED

Event H7-1 Draft ER Finding of No Significant Impact Food Quality Protection Act Farm Service Agency Food Standards Australia NewZealand feet Genetic engineering or geneticallyengineered Genetically modified Genetically modified organism Global Positioning System Glyphosate resistant Glyphosate-tolerant Hazard quotient Harmonized TariffSchedule Institute of Medicine and National Research Council Integrated pest management Isopropylamine International Seed Federation NationalAgricultural Statistical Service (USDA) National Environmental Policy Act No-Observed-Adverse-Effect-Level National Organic Program National Research Council Organization for Economic Cooperation and Development Open-pollinated Office ofScience and Technology Policy Polymerase chain reaction Post Harvest Intervals Plantwith a Novel Trait Polyethoxylated TallowAmine Plant Protection Act Personal Protective Equipment Pre-plant incorporated (herbicide) Recombinant DNA Reregistration Eligibility Decision

ii Table ofContents 7/28/2010RfD RR R&D SBRED SOP TUG T-DNA UC U.S. USC USDA USDC USFWS WCBS WHO WSSA WVSSA

Event H7-1 Draft ER Reference Dose Roundup Ready® Research and Development Sugar beet Research and Education Board of Minnesota and North Dakota Standard Operating Procedures Technology Use Guide Transferred DNA University ofCalifornia United States United States Code US Department ofAgriculture U.S. District Court U.S. Fish and Wildlife Service West Coast Beet Seed Company World Health Organization Weed Science Society ofAmerica Willametle Valley Specialty Seed Association

iii Table ofContents 7/28/2010

### TABLE OF CONTENTS



### INTRODUCTION.................................................................................1 1.1 PURPOSE OF THIS ER

................................................................ 1 1.1.1 Background

...................................................................... 1 1.1.2 Purpose of and need for action

............................................3 1.1.3 APHIS proposed interim measures/time frames for implementation

.................................................................3 

### 1.2 RATIONALE FOR CREATION OF EVENT H7-1

..................................8 1.3 COURT RULING AND ISSUES IDENTIFIED

.....................................9 1.3.1 Gene transmission from H7-1 sugar beets in production fields

.. 9 1.3.2 Gene transmission to conventional sugar beets in seed production

...................................................................... 10 1.3.3 Gene transmission to red table beets and Swiss chard

.......... 10 1.3.4 Socioeconomic impacts

..................................................... 10 1.3.5 Willingness of buyers to accept sugar derived from GE sugar beets

............................................................................. 11 1.3.6 Restrictions/labeling requirements by some countries on GE products

......................................................................... 11 1.3.7 Potential for development of glyphosate-resistant weeds

....... 11 1.3.8 Cumulative effects of increased use of glyphosate

................ 12 

### 1.4 FEDERAL REGULATORY AUTHORITY
- COORDINATED FRAMEWORK 12 1.4.1 USDA Regulatory Authority

............................................... 13 1.4.2 EPA regulatory authority

................................................... 14 1.4.3 FDA regulatory authority

................................................... 14 

### 1.5 THE 

### NATIONAL ORGANIC PROGRAM AND BIOTECHNOLOGy

.......... 15 1.5.1 Non-GMO Project Working Standard

................................... 17 1.5.2 Growth in organic and GE farming

...................................... 17 

### 1.6 COEXISTENCE IN US AGRICULTURE

........................................... 17 1.6.1 Coexistence and biotechnology

.......................................... 17 1.6.2 USDA position on coexistence and biotechnology

.................. 18 1.6.3 Coexistence in US crop production

..................................... 19 

### 1.7 ROLE OF THE 

### NATIONAL ACADEMIES IN AGRICULTURAL BIOTECHNOLOGy

.................................................................... 20 1.8 ALTERNATIVES CONSIDERED

.................................................... 21

Event H7-1 Draft ER 

### 1.8.1 Alternative 1 - No Action (full regulation)

............................ 21 1.8.2 Alternative 2 - Partial Deregulation with Interim Conditions

... 21

iv Table of Contents 7/28/2010

### SECTION 2.0 AFFECTED ENVIROMENT.............................................22 AFFECTED ENVIROMENT..................................................................22 

### 2.1 SUGAR BEET CHARACTERISTICS AND USES

................................ 22 2.2 ACCEPTANCE OF EVENT H7-1 SUGAR BEETS

............................... 23 2.3 SUGAR BEET ROOT PRODUCTION

.............................................. 24 2.3.1 US Production by regions

.................................................. 24 2.3.2 Grower-processor relationships

.......................................... 27 2.3.3 Sugar beet cultivation practices

......................................... 29 2.3.4 Sugar beet bolters and volunteers

...................................... 31 

### 2.4 GENE FLOW

............................................................................ 36 2.5 SUGAR BEET WEED MANAGEMENT

............................................. 39 2.5.1 Weed characteristics and concerns
..................................... 39 2.5.2 Sugar beets and weeds

..................................................... 40 2.5.3 Problem weeds in sugar beet production

............................. 41 2.5.4 Other non-herbicide weed management practices

................. 43 2.5.5 Use of herbicides to control weeds

..................................... 43 2.5.6 Weed control with conventional sugar beets

........................ 43 2.5.7 Weed control with event H7-1

........................................... 51 

### 2.6 HERBICIDE RESISTANCE

.......................................................... 51 2.7 SUGAR BEET SEED PRODUCTION

............................................... 53 2.7.1 Variety development

........................................................ 53 2.7.2 Hybrids and cytoplasmic male sterility

................................ 54 2.7.3 Commercial sugar beet seed production

.............................. 55 

### 2.8 RED TABLE BEET, SWISS CHARD, AND SPINACH BEET PRODUCTION62 2.S.1 Vegetable beet production

................................................. 62 2.S.2 Red table beet and Swiss chard seed production

.................. 63 2.S.3 Organic Red Table Beet and Swiss Chard Production

............. 65 

### 2.9 NATIVE AND UNCULTIVATED NON-NATIVE BEETS

........................ 70 2.9.1 Native beets

.................................................................... 70 2.9.2 Uncultivated wild beets in the US

....................................... 70 2.9.3 Weed beets

..................................................................... 74 2.9.4 Feral crops
...................................................................... 75 

### 2.10 FOOD AND FEED USES OF SUGAR BEET

...................... 76 

### 2.11 2.12

Event H7-1 Draft ER 

### PHYSICAL AND BIOLOGICAL ISSUES

........................... 76 SOCIOECONOMICS AND HEALTH

................................ 76

v Table ofContents 7/28/2010

### SECTION 3.0 ENVIRONMENTAL CONSEQUENCES
.............................78 

### 3.1 PLANT PEST PROPERTIES AND UNINTENDED EFFECTS

.................. 78 3.1.1 Background

.................................................................... 78 3.1.2 Evaluation of intended effects

............................................ 82 3.1.3 Evaluation of possible unintended effects

............................ 83 

### 3.2 WEEDINESS PROPERTIES, VOLUNTEERS AND FERAL CROPS

.......... 85 3.2.1 Weediness properties ofsugar beet..

.................................. 85 3.2.2 Event H7-1 sugar beet and weediness

................................ 85 3.2.3 Sugar beet volunteers

...................................................... 86 3.2.4 Impact summary
............................................................. 87 

### 3.3 IMPACTS OF EVENT H7-1 SUGAR BEET ROOT CROPS ON CONVENTIONAL SUGAR BEET CROPS

......................................... 88 3.3.1 Pollen sources in production fields

...................................... 88 3.3.2 Potential for gene flow in root production fields

.................... 89 3.3.3 Potential for mixing of event H7-1 and conventional sugar beets89 3.3.4 Consequences of gene flow in production fields

.................... 90 3.3.5 Potential consequences from mechanical mixing

................... 90 3.3.6 Impact Summary

............................................................. 91 

### 3.4 IMPACTS OFOF EVENT H7-1 ROOT CROPS ON ORGANIC SUGAR BEET CROPS

................................................................................... 92 3.4.1 Impact summary
............................................................. 92 

### 3.5 IMPACTS OFOF EVENT H7-1 ROOT CROPS ON OTHER 

### BETA (NONSEED) CROPS

......................................................................... 92 3.5.1 Impact summary
............................................................. 93 

### 3.6 IMPACTS OF EVENT H7-1 SUGAR BEET ROOT CROPS ON OTHER 

### BETA SEED PRODUCTION AREAS

....................................................... 94 3.6.1 Impact summary
............................................................. 94 

### 3.7 IMPACTS OF EVENT H7-1 ROOT CROPS ON NATIVE BEETS

............ 95 3.7.1 Impact summary
............................................................. 95 

### 3.8 IMPACTS OF EVENT H7-1 CROPS ON NON-NATIVE WILD AND WEEDBEETS

........................................................................... 95 3.8.1 Impact summary
............................................................. 96 

### 3.9 IMPACTS OF EVENT H7-1 SEED PRODUCTION ON CONVENTIONAL SUGAR BEET AND OTHER 

### BETA SEED CROPS

.............................. 97

Event H7-1 Draft ER 

### 3.9.1 Maintaining seed purity, identify and quality

........................ 97 3.9.2 Summary of practices for sugar beet seed production

........... 98 3.9.3 Sugar beet seed production since 2007

............................... 98 3.9.4 Measured sugar beet pollen dispersal

.................................100 3.9.5 Modeled sugar beet pollen dispersal

..................................101

vi Table ofContents 7/28/2010

### 3.9.6 Site-specific assessment of cross-pollination potential in the Willamette Valley

............................................................101 3.9.7 Use of event H7-1 trait on male-sterile female

....................102 3.9.8 Red table beet offtypes

....................................................102 3.9.9 No sensitivity to event H7-1 by conventional sugar beet growers; Stewardship regarding mechanical mixing

.............103 3.9.10 Question ofzero tolerance

...............................................104 3.9.11 Seed availability

.............................................................105 3.9.12 Impact Summary

............................................................105 

### 3.10 LIVESTOCK PRODUCTION SySTEMS

...........................107 3.11 FOOD AND FEED

.....................................................107 3.11.1 FDA authority and policy

..................................................108 3.11.2 FDA biotechnology consultation note to the file BNF 000090.109 3.11.3 Health Canada approval 2005

...........................................112 3.11.4 Canadian Food Inspection Agency (CFIA) approval 2005

......112 3.11.5 EFSA risk assessment and EC authorization

........................113 3.11.6 Other approvals

..............................................................114 3.11.7 Willingness ofthe buyer to accept sugar from event H7-1.

....115 3.11.8 Impacts

.........................................................................115 

### 3.12 WEED CONTROL AND GLYPHOSATE RESISTANCE

.........116 3.12.1 Herbicide-resistant weeds

................................................116 3.12.2 Glyphosate-resistant weeds

..............................................119 3.12.3 Impact summary
............................................................122 

### 3.13 PHYSICAL.

..............................................................123 3.13.1 Land Use

.......................................................................123 3.13.2 Air Quality and Climate

....................................................125 3.13.3 Surface water quality

......................................................126 3.13.4 Groundwater quality

........................................................127 

### 3.14 BIOLOGICAL

...........................................................128 3.14.1 Plant and Animal Exposure to Glyphosate

...........................128 3.14.2 Threatened and Endangered Species

.................................134 

### 3.15 HUMAN HEALTH AND SAFETY

....................................136 3.15.1 Consumer Health and Safety

............................................136 3.15.2 Hazard Identification and Exposure Assessment for Field Workers

........................................................................137 

### 3.16 ECONOMIC IMPACTS

................................................139

Event H7-1 Draft ER 

### 3.16.1 Sugar beet processing

.....................................................139 3.16.2 USDA's role in sugar marketing

.........................................140 3.16.3 Economic Impacts

...........................................................140

vii Table ofContents 7/28/2010

### 3.17 SOCIAL AND ECONOMIC IMPACTS ON RED BEET AND CHARD GROWERS

..................................................................145 SECTION 4.0 CUMULATIVE IMPACTS
.............................................148 

### 4.1 CLASS OF ACTIONS TO BE ANALyZED

.......................................148 4.2 GEOGRAPHIC AND TEMPORAL BOUNDARIES FOR THE ANALYSIS

..148 4.3 PARTIAL.CUMULATIVE IMPACTS RELATED TO THE DEVELOPMENT OF GLYPHOSATE RESISTANT WEEDS

.............................................149 4.4 CUMULATIVE IMPACTS OF POTENTIAL INCREASED GLYPHOSATE USAGE WITH THE CULTIVATION OF GLYPHOSATE TOLERANT CROPS149

Event H7-1 Draft ER 

### 4.4.1 Land Use, Air Quality and Climate

.....................................

### 152 4.4.2 Water Quality

.................................................................

### 152 4.4.3 Biological

.......................................................................

### 153 4.4.4 Human Health and Safety

................................................

### 154 4.4.5 Summary of Potential Cumulative Impacts from Increased Use of Glyphosate

.................................................................160

viii Table ofContents 7/28/2010APPENDICES A Willametle Valley Specialty Seed Association (WVSSA) specialty seed production isolation guidelines and Columbia basin vegetable seed field isolation standards B West Coast Beet Seed Company protocol for genetically modified (GM) seed production and GM grower guidelines C International Seed Federation Code ofConduct D Sugar Beet Production by County and State E 

### 2010 Technology Use Guide (TUG) TABLES Table 

### 2-1 Table 

### 2.2 Table 

### 2-3 Table 2-4 Table 3-1 Table 

### 3-2 Table 

### 3-3 Table 4-1 Table

### 4-2 Table 4-3 Table 4-4 Table 4-5
FIGURES Figure 

### 1-1 Figure 

### 2-1 Figure 2-2 Figure 

### 2-3. Figure 

### 2-4 Figure

### 2-5 Figure 

### 2-6. Figure 

### 2-7 Figure 

### 2-8 Figure 

### 2-9 Figure

### 2-10 Figure 4-1

Event H7-1 Draft ER U.S. sugar beet production, 2009/2010 season Rotational crops following U.S. sugar beet production and an estirnation of rotational crops as Roundup Ready® crops Herbicide applicationsto sugar beet acres in the U.S., 

### 2000 Effectiveness of herbicides on majorweeds in sugar beets Majorsugar beet weeds with resistance to herbicide groups used in sugar beets Sugar beet acres planted 

### 2005 to 

### 2010 Production loss and project costs from a GT sugar beet injunction Comparison of Potential Effects ofGlyphosate and Sugar Beet Herbicides on Freshwater Fish Comparison of Potential Effects ofGlyphosate and Sugar Beet Herbicides on FreshwaterAquatic Invertebrates Comparison ofPotential Effects ofGlyphosate and Sugar Beet Herbicides on Aquatic Plants (Algae and Duckweed) Alternative Herbicidesfor Weed Control in Sugar Beets
- Label Comparison 1 Exposure Mitigation Potential Reduction in Risk from Use ofGlyphosate Compared to Traditional Herbicides Used in US Sugar Beet Production

Alternative 

### 3 Roundup Ready® Sugar Beet-Free Zone U.S. sugar beet regions and county production 

### 2010 distribution by state ofacres planted in sugar beets Herbicide resistance worldwide Willametle Valley Distribution of"other" organicvegetable production, 

### 2008 California acreage oforganic beets (non-sugar), 

### 2007 California gross sales oforganic beets (non-sugar), 

### 2007 California acreage oforganiC Swiss chard, 

### 2007 California gross sales oforganic Swiss chard, 

### 2007 All CA counties with Beta records Growth in adoption ofgenetically engineered crops in US

ix Table ofContents 7/28/2010

### INTRODUCTION

This Environmental Report (ER) examinesthe environmental impacts ofcontinued cultivation of Roundup Ready® sugar beet event H7-1 (event H7-1) for atemporary period subjectto a range ofinterim measures, including geographic restrictions, stewardship requirements and other limitations
-- identified and analyzed by the US Department ofAgriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) in CenterforFood Safety v. Vi/sack, 

### No. OB-4B4, N.D. Cal. This ER is provided in connection 

### with the petitioners' supplemental requestfor nonregulated status in part

### (commonly known as "partial deregulation") for event H7-1. This document is intended to provide information that may be utilized byAPHIS in complying with the National Environmental PolicyAct (NEPA)' and its applicable regulations2 

### either in connection with partial deregulation ofevent H7-1 orfor any other regulatory or administrative action by APHIS adopting the interim measures addressed herein. The interim measures are intended to apply until APHIS completes its NEPA review ofthe petition for nonregulated status for event H7-1 and reaches afinal determination regarding the petition. The sugar produced from sugar beets, which were planted on approximately 1.2 million acres in the US in 2010, accounts for over halfthe US sugar production. Cash receipts for sugar beets were $1.3 billion in the 2007-200B crop year. Event H7-1, which has been genetically engineered to be tolerantto the herbicide glyphosate, has been grown on a large scale in the US for multiple years and accounted for approximately 95 percent ofthe sugar beet planted in the US in the 2009/2010 

### crop year (USDA NASS, 201**~b;** 

### USDA ERS, 2009a and 2009b). 

### 1.1 PURPOSE OF THIS ER 1.1.1 Background 

### In 2003, underthe requirements ofthe Plant Protection Act (PPA),3 Monsanto Company and KWS SAATAG (Monsanto/KWS) submitted a petition (Petition No. 03-323-01P) to APHIS for a determination ofnon-regulated status for event H7-1 and all progeny derived by conventional breeding from this event (Schneider, 2003). APHIS, through its Biotechnology Regulatory Service (BRS), is one ofthree federal agencies responsible for regulating biotechnology in the US underthe Coordinated Framework described in Section 1.4. APHIS regulates genetically engineered (GE) organisms that may be plant pests, the Environmental Protection Agency

, NEPA of 1969, as amended; Title 42 ofthe US Code (42 USC) §§4321-4347 2 Council on Environmental Quality (CEQ) regulations implement NEPA and are found in Title 40 of the Code of Federal Regulations (40 CFR), Parts 1500 through 1508. The U.S. Department of Agriculture has implemented NEPA regulations, which are found at7 CFR Part 1b, as has APHIS, and those are found at7 CFR part 372. 3 7 USC §§7701-7786 Event H7-1 Draft 

### ER 1 Introduction 7/28/2010(EPA) regulates plant incorporated protectants and herbicides used with herbicide-tolerant crops, and the US Department of Health and Human Services' Food and Drug Administration (FDA) regulates food and animal feed. The FDA completed its consultation process for event H7-1 in 2004 and EPA agreed that its previous approval for glyphosate residue in sugar beet roots, tops and dried pulp was also applicableto event H7-1 ((Tarantino, 2004; Bonette, 2004; Schneider, 2003, p. 14). NEPA requires federal agencies to evaluatethe potential impactof proposed majorfederal actions and consider such impacts during the decision-making process. After agency reviewfor safety, including an evaluation ofrelevant scientific data and all public comments relating to potential plant pest risks and related environmental impacts, APHIS issued an EA pursuantto NEPA in 2005 (USDA APHIS, 2005). Based on that EA, APHIS reached afinding of no significant impact (FONSI) on the environmentfrom the unconfined cUltivation and agricultural use ofevent H7-1 and its progeny (USDAAPHIS, 2005, p. 1). Accordingly, in March 2005, APHIS granted non-regulated status to event H7-1 (USDAAPHIS, 2005, p. 26). After event H7-1 was deregulated, the multi-year process ofbringing it to commercial production began. Large scale commercial seed production began in 2006 to producethe seed crop used for planting root crops in 2008. Small scale root production occurred in 2006 and 2007. In January 2008, the Organic Seed Alliance, Sierra Club, High Mowing Organic Seeds, and the Center for Food Safety (CFS) filed a lawsuit againstthe USDA over its decision to deregulate event H7-1, claiming the USDAfailed to take a "hard look" atthe environmental effects ofits decision to deregulate. The plaintiffs in the suit did not seek a preliminary injunction to halt planting. In September2009, the court granted the plaintiffs' motion for summaryjudgment in the merits phase ofthe lawsuit, concluding thatAPHIS was required to prepare an environmental impact statement (EIS) before approving its deregulation ofGE sugar beets. In December 2009, the court issued a scheduleforthe remedies phase ofthe lawsuit. Atthat point, representatives ofthousands offamily farms thatwere growing event H7-1 sugar beet root crops along with the four seed companies who produced seed and other interested parties were permitted to participate in the suit. In May 2010, while the remedies phase ofthe lawsuit was proceeding, Cindy Smith, the APHIS Administrator, filed a declaration in the suit anticipating completion ofthe EIS in May2012 (Smith, 2010b, pp. 7-8) and suggested thatthe courtenter an order imposing certain interim measures that would allow continued cultivation ofevent H7-1. These interim measures would include geographic restrictions and a range ofstewardship reqUirements, and would applyfor a Event H7-1 Draft ER 2 Introduction 7/28/2010

### temporary period pending completion ofthe EIS and the corresponding record ofdecision (ROD), and implementation ofthat decision. (Smith, 2010b, pp. 19-22). Alternatively, Administrator Smith proposed that the Court remand the case to APHIS with the intention that APHIS would take action to implementthese interim measures administratively. On May 25, 2010, APHIS issued a notice ofintentto prepare an EIS and a proposed scope ofstudy (APHIS 2010). On June21,2010, the U.S. Supreme Court ruled in litigation related to Roundup Ready® alfalfa, clarifying that a court in a NEPA case may not preemptively barAPHIS from issuing a "partial deregulation" ortaking other administrative action to implement interim measures for cUltivation ofa genetically engineered crop while the agency completes an EIS evaluating complete deregulation. Monsanto Co. v. Geertson Seed Farms, No. 09-475, 561 U.S. (2010). 1.1.2 Purpose ofand need foraction. The purpose ofthis ER, which has been prepared to support an anticipated EA, is to examine the environmental impacts of implementing interim measures, eitherthrough a partial deregulation ofevent H7-1 lines of glyphosatetolerant sugarbeets or certain other administrative means. The interim measures have been identified to address concerns regarding potential impacts related to the planting and cultivation ofevent H7-1 while the EIS evaluating complete deregulation is being prepared. IfAPHIS concludes that an EA supports a FONSI forsuch interim rneasures, APHIS could decideto implement such measures through "partial deregulation" pending APHIS's determination on complete deregulation. 1.1.3 APHIS proposed interim measures/timeframes for implementation APHIS' proposed interim measures for Roundup Ready® sugar beets (RRSB), to be implemented eitherthrough a partial deregulation or other administrative means, are detailed below. These measures arethe same as those proposed by Administrator Smith to the court (Smith, 2010b, pp. 19-22), along with time frames for implementation ofthose measures
. 

### .Interil1l11leaSliresProposedby

### APHISto tfle COllrt Administrator Smith proposed the following interim measures in the lawsuit discussed above: 1) 

### Roundup ReadY'SugarBeet-FreeZone The planting of RRSB is prohibited in the entire State ofCalifornia and in the State of Washington in the following counties west ofthe Cascades: Clallam, Jefferson, Grays Harbor, Island, Pacific, Mason, Thurston, Lewis, Cowlitz, Clark, Whatcom, Skagit, Snohomish, King, Event H7-1 Draft ER 3 

### Introduction 7/28/2010

### Pierce, Skamania, San Juan, Kitsap, and Wahkiakum Counties. [These counties are shown in this ER in Figure 1-1]. 

### 2) A Coexistence Zone forBeta Seed Crop Production in the Willamette Valleyin Oregon
a. All parties to this action who grow Beta seed crops in the Willamette Valley must adhere to afour mile isolation distance between RRSB seed crops and other Beta seed crops. b. All parties to this action who grow Beta seed crops in the Willamette Valley must follow the Willamette Valley Specialty Seed Association (WVSSA) pinning procedures. 3) Disclosure ofInformation Regarding Male Fertile RRSB Seed Crops. All growers of RRSB male fertile seed crops must provide locations with GPS coordinates to APHIS/BRS ofany RRSB malefertile seed crops in the United States that exist atthetime the Court's Order is issued orthat are planted at any time during the interim period in which the EIS is being prepared. Information regarding existing plantings must be provided to APHIS within 30 days after issuance ofthe Order; information regarding future plantings during the interim period must be provided to APHIS within one week afterthe completion ofplanting ofany RRSB male fertile seed crops. Within 

### 60 days after issuance ofthe Order, APHIS/BRS shall set up a toll-free numberthat growers ofnon-GE Beta seed crops may use to request from APHIS/BRS the approximate distances from the nearest RRSB male fertile seed crop to their non-GE Beta seed crop. Upon calling this number, the caller shall certify to APHIS/BRS thatthe caller is agrower ofnonGE Beta seed crops or intends to grow non-GE Beta seed crops at an existing location in the United States. APHIS/BRS shall only provide to the callerthe approximate distancefrom the nearest RRSB malefertile seed crop location to the caller's non-GE Beta seed crop.

Event H7-1 

### Draft ER 4 

### Introduction 7/28/2010

### BRITISHCOLUt'v\BIA**~,-~"-"-,,-,,-,,-,,-,,--,,,,-,,-,,,,-,,--,-,,~"-",-"-1**

Chelan

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Yakima

Klickitat



### OI,ECON 

### Figure 1-1. Roundup Ready® Sugar Beet-Free Zone Sources: Smith, 2010b; NationalAtlas ofthe UnitedStates

Event H7-1 Draft ER 

### 5 Okanogan

Douglas

Grant

Benton Ferry Slevens

Lincoln

Adams

Franklin

- Wall, Wall, Pend Dreme

Spokane

Whitman

Garfield

Introduction 7/28/2010

### 4) Measures to PreventMixing ofConventional SugarBeetSeedandRRSB. RRSB seed producers shall follow protocols to ensure that mechanical mixing ofmaterial containing the RRSB trait and non-GE Beta seeds does not occur. Those protocols shall include:

a. A visual identification system for RRSB material (basic seed, stock seed, transplants (stecklings), and commercial seed) that accompanies seed material throughout the production system to delivery to ultimate purchaser; b. 

### Acompanion seed-lot based tracking and tracing system that is fully auditable;
c. Requirements for physical separation of RRSB material at all points in the seed production process from non-GE Beta material; d. Requirements for monitoring, treating, and cleaning of all planting, cultivation and harvesting equipment to prevent RRSB seed, pollen or stecklings from being physically transferred out ofproduction areas by inadvertent means;
e. Requirements for disposal ofall unused RRSB stecklings by returning unused stecklings to the nursery field of origin and subsequent destruction through standard agricultural practices (physical destruction with tillage and chemical destruction in the subsequent crop);); f. Requirements for contained seed transport from field to cleaning facility, vehicle cleaning aftertransport of RRSB seed before use for other purposes, and devitalization of RRSB material derived from cleaning vehicles or processing facilities; g. Prohibition on grower production of a RRSB seed and chard/red beet seed production on the same location/premises in the same year; h. Prohibition on RRSB seed grower use or sharing of planting/cultivation equipment that might be used in a non-GE Beta seed production in the same growing year; i. 

### Prohibition on RRSB seed grower use ofthe same combine to harvest RRSB and nonGE Beta seed in the same year;

Event H7-1 

### Draft ER 6 

### Introduction 7/28/2010

### j. Provisions to force same-year sprouting ofany RRSB seed left behind in production field for removal and destruction; plus 3-year monitoring of fields thereafter, along with removal and destruction ofany beet plants; k. Employee training in all aspects ofa. through j. above; I. No RRSB seed shall be cleaned or processed in any processing facility that also cleans and processes red beet or Swiss chard seed;
m. Recordkeeping to documentcompliance ofa-I. 5) Control of AnyBolters in the RRSB Root Crop Fields. All RRSB root crop growers must have contractual measures in place that require RRSB root crop growersto survey, identify, and eliminate any bolters in their root crop fields before they produce pollen orset seed. 6) Controlof AnyBolters in HarvestedRRSB Root Crop in OutdoorStorage. All sugar beet processors or cooperatives that use RRSB must have measures in place to survey, identify, and eliminate any bolters in outdoor storage before they produce pollen or set seed. 7) ThirdPartyAuditforCompliance. APHIS will requirethird party audits to ensurethat RRSB producers comply with requirements in paragraphs two and four above. APHIS expects thatAMS [Agricultural Marketing Service], USDA, will be thethird party auditor using its AMS-USDA Process Verified Program. 

## Time ji'ame forImplemelltatioll
While certain interim measures could be implemented shortly afterAPHIS issues its interim order ofpartial deregulation ortakes other administrative action regarding event H7-1 (e.g., Item 3), certain measures may require some additional time to fully implement. This ER makesthe following assumptions as to when thevarious components ofthe interim measures would be implemented: (1) RRSB-free zone. The sugar beet seed companies have represented that no RRSB sugar beet crops have been orwould be planted in California orthe subject counties in Washington State. Thus, these restrictions can be implemented immediately.
Event H7-1 Draft ER 7 

### Introduction 7/28/2010

### (2) Willametie Valleycoexistence zone While certain isolation distance and pinning requirements have already existed for years, the four-mile isolation distance and the pinning and audit requirements proposed in the interim measureswill be implemented in full with the summer2011 seed crop planting, which will occur in July and August of2011 (Items 2 and 7). The current isolation distance provided bythe Willamette Valley Specialty Seed Association pinning provisions is four miles between sugar beetseed crops on one hand and open-pollinated (OP) red beet or chard seed crops on the other. Mostofthese crops will have been pinned and planted bythe end ofAugust 2010. 

### 3) Disclosure ofinformation regarding male fertile crops Timeframes are included in the proposed interim measures, described above. 4) 

### Measures topreventmixing ofseed While these measures have already largely been implemented in the majorseed production area, as discussed in Section 2.7.3 ofthis ER, we assumethatfull implementation will occur before the 2011 seed harvest. 

### 5) Control ofbolters
- rootcrop fields Contracts requiring control of bolters are in place currently forthe 2011 spring planting. 

### 6) Control ofbolters
- rootcrop outdoorstorage These measures will be in place beforethe 2011 harvest. 

### 7) Third-partyaudits Measureswould be in place atthe time ofthe partial deregulation orother administrative action imposing the interim measures. 

### 1.2 RATIONALE FOR CREATION OF EVENT H7-1 Event H7-1 offers sugar beet growers a simpler, moreflexible, and less expensive alternative forweed control relative to conventional weed control measures. According to the World Agriculture Series volume 

### SugarBeets, "Weeds have been a major problem in sugar beetsince the crop was first grown in the late 1700s" and "unlike insects, diseases and nematodes, weeds occur in all sugar beetfields every year, usually at populations that cause crop failure unless controlled" (May and Wilson, 2006, p. 359). Other researchers,

Event H7-1 Draft ER 8 Introduction 7/28/2010

### working before the introduction ofevent H7-1, have reported that "weed management is one of the main production costs with sugar beet" (Odero et ai, 2008, p. 50). As discussed in detail in Section 2.5, priorto widespread cUltivation ofevent H7-1, sugar beet growers used a variety ofmeans to control weeds, and herbicides are a key component. Herbicides are used by virtually all sugar beet growers; in 2000, approximately 98 percent of planted sugar beet acres received one or more herbicide applications (Ali, 2004, Table 4). In the 2000 growing season, 12 different active ingredientsformulated as various herbicide products were commonly used in U.S. sugar beet production with a total ofabout 1.4 million pounds of herbicides applied (USDA APHIS, 2005, pp. 6-7). Typical conventional weed control consists ofmultiple applications ofseveral different herbicides, often combined with hand or mechanical weeding (Odero et ai, 2008). Glyphosate is little-used for conventional sugar beets (those without glyphosatetolerance) because it damages the plants. With glyphosate-tolerant sugar beets, growers have an additional option forweed control. 

### 1.3 COURT RULING AND ISSUES IDENTIFIED During the lawsuit discussed above, the court identified certain specific issues as requiring additional analysis by APHIS (US District Court [USDC] 2008). These issues are described below and are addressed in the Affected Environment and Environmental Consequences sections ofthis ER. Additionally, this ER addresses issues thatwere notfound to be problematic by the court in APHIS' initial EA. These issues are nevertheless addressed again here to ensurefull disclosure and analysis of any potential impacts associated with partial deregulation ofevent H7-1 under the proposed interim measures. 1.3.1 Gene transmission from H7-1 sugar beets in productionfields Sugar beet is largelywind pollinated and has a biennial, two year life cycle when grown for seed; plants develop a large rootthe first year, then overwinter and flower, producing a seed stalk the second year. When grown to produce sugar, sugar beet roots are harvested during the firstyearwhile still in the vegetative (non-flowering) phase. Sugar beets grown for root crops rarely flower and thus rarely produce any pollen. However, certain conditions such as low temperatures after planting and longerday length can occasionally cause the sugar beetto "bolt" or produce a seed stalk (which can ultimately flower) during the first growing season (8ell 1946; Jaggard eta/. 

### 1983; Durrant and Jaggard 1988). Thus, further analysis to determinethe

Event H7-1 Draft ER 9 

### Introduction 7/28/2010

### potential for gene transmission from event H7-1 being grown for root production to conventional sugar beets was conducted and is discussed in Section 3.3 ofthis ER. 

### 1.3.2 Genetransmission to conventional sugar beets 

### in seed production Unlike sugar beet root production, seed production requires thatthe plants flower, become pollinated and develop seed. The court concluded thatAPHIS did nottake a "hard look" at the potential for genetransmission in seed production in its initial EA in reference to the 2003 petition, and did not considerthe factthat isolation distances set by the Oregon Seed Certification Standards are voluntary; whetherthe isolation distanceswere actuallyfollowed and are likely to be followed in the future; or ifthe isolation distances are sufficientto protectthe non-GE crops that are inter-fertile with sugar beets. Therefore, further analysis to determine the potential for gene transmission from sugar beets being produced for seed production was conducted and is discussed in Section 

### 3.9 ofthis ER. 

### 1.3.3 Gene transmission to red table beets and Swiss chard Cross-pollination between cultivated sugar beet and sexually compatible Beta species can occurwhen these plants grow close together and have overlapping flowering periods. The court found that because sugar beet pollen can travel large distances bywind, and because seed for sugar beets, Swiss chard, and table beets (which are all members ofthe same species and are all sexually compatible) are all grown in one valley in Oregon (albeit principally in different parts ofthe same valley), additional analysis is required to determinewhether deregulation may significantly affectthe environment as a result ofany potential cross-pollination. Therefore, further analysis was conducted and is discussed in Sections 

### 3.5 and 

### 3.6 ofthis ER. 

### 1.3.4 Socioeconomic impacts The courtfound that APHIS failed to analyze in its initial EA the socio-economic impacts of deregulating event H7-1 on farmers and processors seeking to avoid GE sugar beets and derived products, stating, Economic effects are relevantandmustbe addressedin the environmentalreview "when theyare 'interrelated' with 'naturalorphysicalenvironmentaleffects.'"Ashley CreekPhosphate Co. v. Norton, 420 F.3d934, 944 (9th Cir. 2005) (emphasis in original) (quoting

### 40 C.F.R. 1508.14); see also Geertson SeedFanns v. Johanns, 2007 WL 518624, *7 (N.D. Cal. Feb. 13,2007). In Geertson SeedFarms, the courtfound that "the economic effects on the organic andconventional fanners ofthe govemment's deregulation decision are interrelated with, and, indeed, 

### a directresultof, the effecton
Event H7-1 Draft 

### ER 10 

### Introduction 7/28/2010

### thephysical environment; namely, the alteration of

### a plantspecie[sj'DNA through the transmission ofthe geneticallyengineeredgene to the organic andconventional[crop]." Id., 2007 WL 518624, *8 

### (emphasis added). The court held thatAPHIS was required to considerthese effects in assessing whetherthe impact of its proposed action ofderegulationwas significant. Therefore, further analysis was conducted and is discussed in Section 3.17 ofthis ER. 1.3.5 Willingness of buyers to acceptsugarderivedfrom GEsugar beets The court's ruling included a reference to a 2004 comment from Imperial Sugar, a company that atthattime processed sugar beets (but no longer does) and currently produces and markets only cane sugar. Imperial Sugar raised a concern in response to the petition for deregulation that buyers of industrial and consumer sugars have expressed reluctance or opposition to receiving sugarderived from GE sugar beet. Imperial Sugar's opinion was thatthe industrial buyers' reluctance was caused by their beliefthat consumers would react negatively to products containing orderived from GE crops. Imperial Sugarwas therefore concerned that industrial buyers would be unwilling to testthe reaction ofconsumers by using sugar from event H7-1 in their branded products. Currently, event H7-1 sugar beet is processed into a large percentage ofourdomesticsugar supply, and has been well accepted. Nevertheless, further analysis ofthis issue was conducted and is discussed in Section 3.11 ofthis ER. 1.3.6 Restrictionsllabeling requirements by some countries on GE products Imperial Sugar also commented that some countries will not allow GE products to be imported and that many nations require labeling offood products with GE content. However, less than two percent ofthe sugar produced in the US is exported (USDA FAS, 2010), and exports of products derived from event H7-1 sugar beets are expressly allowed in manyforeign countries. Further information is available in Section 3.11 ofthis ER. 1.3.7 Potential for development ofglyphosate-resistantweeds As the adoption ofglyphosate-tolerant crops has grown, the use ofglyphosate has increased (National Research Council [NRC]. 2010, Figures S-1, S-2, and S-3; Young, 2006). Concerns have been expressed that increased use ofglyphosate may lead to development ofglyphosateresistantweeds. Further information is available in Sections 2.5 and 3.12 ofthis ER.

Event H7·1 Draft ER 11 Introduction 7/28/20101.3.8 Cumulative effects of increased use ofglyphosate Further analysis ofcumulative impactsfrom increased use ofglyphosatewas conducted and is discussed in Section 

### 4 ofthis ER. However, sincethis ER is intended to address only the period oftime until the EIS is completed, cumulative effects are considered forthattime period. 

### 1.4 

### FEDERAL REGULATORY AUTHORITY- COORDINATED FRAMEWORK Interagency coordination in scientific and technical matters is the responsibility ofthe federal Office ofScience and Technology Policy (OSTP), which was established by law in 

### 1976. A large part ofthe OSTP's mission is "to ensure thatthe policies ofthe Executive Branch are informed by sound science" and to "ensurethatthe scientific and technical work ofthe Executive Branch is properly coordinated so as to provide the greatest benefit to society" (OSTP, undated). In 

### 1986, the OSTP published a "comprehensivefederal regulatory policy forensuring the safety of biotechnology research and products", the CoordinatedFramework forthe Regulation of Biotechnology(Coordinated Framework) (OSTP, 

### 1986). The OSTP concluded thatthe goal of ensuring biotechnology safety could be achieved within existing laws (OSTP, 

### 1986). The Coordinated Framework specifiesthree federal agencies responsiblefor regulating biotechnology in the US: USDA's APHIS, the EPA, and the FDA. APHIS regulates GE organisms underthe Plant Protection Act of

### 2000 (PPA). EPA regulates plant-incorporated protectants and herbicides used with herbicide-tolerant crops underthe Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Federal Food, Drug, and CosmeticAct (FFDCA). FDA regulates food (including animal feed, but not including meat and poultry, which is regulated by USDA), including food and feed produced through biotechnology, underthe authority ofthe FFDCA. Products are regulated according to their intended use and some products are regulated by more than one agency. Together, these agencies ensure thatthe products ofmodern biotechnology are safe to grow, safe to eat, and safe forthe environment. USDA, EPA, and FDA enforce agency-specific regulations to products ofbiotechnologythat are based on the specific nature ofeach GE organism. In 

### 2001, in ajoint CEQ/OSTP assessment offederal environmental regulations pertaining to agricultural biotechnology, the CEQ and OSTP found that "no significant negative environmental impacts have been associated with the use ofany previously approved biotechnology product" (CEQ/OSP, 

### 2001, p. 

### 1).

Event 

### H7-1 Draft ER 

### 12 Introduction 7/28/2010

### For glyphosate-tolerant sugar beet event H7-1, the plant is reviewed by USDA and FDA, whereas EPA is responsible for registering the use ofthe glyphosate herbicide and establishing a tolerance for allowable glyphosate residues. As indicated herein, although certain issues such as weed resistance and impacts ofglyphosate on animals or plants are addressed by EPA (not APHIS), this ER nevertheless addresses those issues. 1.4.1 USDA Regulatory Authority The Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Service (BRS) mission is to protect US agriculture and the environment using a dynamic and sciencebased regulatory framework that allows forthe safe development and use ofGE organisms. Under its authority from the PPA, APHIS regulates the introduction (importation, interstate movement, or release into the environment) ofcertain GE organisms and products' A GE organism is presumed to be a regulated article ifthe donor organism, recipient organism, vector, or vector agent used in engineering the organism belongs to one ofthetaxa listed in the regulation' and is also presumed to be a plant pest. APHIS also has authority underthese rules to regulate a GE organism ifit has reason to believe that the GE organism may be a plant pest orAPHIS does not have sufficient information to determinethat the GE organism is unlikelyto pose a plant pest risks UnderAPHIS' regulations a person may petition APHIS to evaluate submitted data and determinethat a particular regulated article is unlikelyto pose a plant pest risk, and, therefore, should no longer be regulated. 7 

### The petitioner is required to provide information related to plant pest riskthatthe agency may use to determine whetherthe regulated article is unlikelyto present agreater plant pest riskthan the unmodified organism. 8 

### Ifthe agency determinesthat the regulated article is unlikelyto pose a plant pest risk, the GE organism will be granted nonregulated status. In such a case, APHIS authorizations (i.e. permits and notifications) would no longer be required for environmental release, importation, or interstate movement of the non-regulated article or its progeny. It was underthese regulations that Monsanto/KWS submitted the petition for a determination of non-regulated status for event H7-1 (Schneider, 

### 2003). Event H7-1 sugar beets were considered regulated because they contain non-coding DNA segments derived from plant

: 7 C.F.R §.340

7 C.F.R §.340.2 6 7 C.F.R §.340.1 77 C.F.R §.340.6 entitled "Petition for determination of nonregulated status" Bid. §340.6(c)(4) Event 

### H7-1 Draft 

### ER 13 

### Introduction 7/28/2010

### pathogens and the vector agent used to deliverthe transforming DNA is a plant pathogen (See Section 3.1 for a discussion ofthese concepts) (APHIS, 2005, p. 4). 1.4.2 EPA 

### regulatory authority EPA is responsible for regulation ofpesticides (including herbicides such as glyphosate) under the FIFRA. 9 

### FIFRA requires that all pesticides be registered before distribution, sale, and use, unless exempted by EPA regulation. Before a product is registered as a pesticide under FIFRA, it must be shown that when used in accordance with the label, itwill not result in unreasonable adverse effects on the environment. EPA granted the registration ofglyphosate for use overthe top ofsugar beets on March 31, 1999. Underthe Federal Food, Drug, and Cosmetic Act (FFDCA), as amended,'° pesticides added to (or contained in) raw agricultural commodities generally are considered to be unsafe unless a tolerance orexemption from tolerance has been established. EPA establishes residue tolerances for pestiCides underthe authority ofthe FFDCA. EPA is required, before establishing pesticide tolerance to reach a safety determination based on afinding of reasonable certainty of no harm underthe FFDCA, as amended bythe Food Quality Protection Act of 1996 (FQPA). The FDA enforces the tolerances set by the EPA. EPA established atolerance forglyphosate residue found on beets, including sugar, roots, tops, and dried pulp on April 14, 1999 (64 Fed. Reg. 18360). 1.4.3 

### FDA regulatory authority In 1992 FDA, which has primary regulatory authority overfood and feed safety, published a policy statement in the Federal Register concerning regulation ofproducts derived from new plant varieties, including those genetically engineered (FDA, 1992). Underthis policy, FDA uses a consultation process to ensurethat human food and animal feed safety issues or other regulatory issues (e.g. labeling) are resolved priorto commercial distribution ofa bioengineered food. Monsanto/KWS submitted a food and feed safety and nutritional assessment summary for event H7-1 to FDA in April 2003. FDA completed its consultation process in August 2004 (Tarantino, 2004; Bonette, 2004).

9 7 USC §136 etseq. 10 21 U.S.C. § 301 etseq. 

### Event H7-1 Draft ER 14 Introduction 7/28/2010

### 1.5 THE NATIONAL ORGANIC PROGRAM AND BIOTECHNOLOGY Congress passed The Organic Foods Production Act of 1990 (OFPA) to avoid the confusion and misrepresentation then taking place in the "organic" marketplace." The OFPA required the USDAto establish a National Organic Program (NOP) to develop uniform standards and a certification processforthose producing and handling food products offered for sale as "organically produced."'2 The OFPA requires certification underthe NOP, which was finalized in 2000, to be process-based. '3 "The certification process does not guarantee particular attributes ofthe end product; rather it specifies and audits the methods and procedures by which the product is produced" (Ronald and Fouche, 2006). The NOP defines certain "excluded methods" of breeding that cannot be used in organic production, describing them as "means that are not possible under natural conditions or processes.""Along with genetic engineering, three other modern breeding techniques are specified as "excluded methods" in the regulations. 's Thus, a certified organic growercannot intentionally plant seeds that were developed bythese specific excluded methods. However, because "organic" is based on process and not product, the mere presence ofplant materials produced through excluded methods in a crop will notjeopardize the integrity of products labeled as organic, as long as the growerfollows the required organic production protocol. Also, other modern breeding methods
- forexample, induced radiation or chemical mutagenesis
- are notspecified as excluded methods by the NOP (discussed in Section 3.1.1). All organic growers' production plans must be approved by an organic certifying agent before the farm can be certified as "organic."'6 Such plans must include, among otherthings, steps the organic grower is taking to avoid whatthe NOP refersto as "genetic drift" from any neighboring crops using excluded methods." Certification must include on-site inspections ofthe farm to verify the procedures setforth in the organic production plan." Thus, the NOP recognizes the coexistence oforganic growers with neighboring growerswho may choose to grow products developed using certain methods of biotechnology. So long as an organic growerfollows an approved organic method of production that seeks to avoid contact

11 7 USC § 6501 etseq. 127 C.F.R. Part205, announced at 65 Fed. Reg. 80548 (Dec. 21,2000). 13 7 U.S.C. 6503(a). 14 7 C.F.R. § 205.2 15 {d. 16 See 7 C.F.R. Part205, Subpt. E. 17 See id. at 205.201; 65 Fed. Reg. at 80556 (discussing "genetic drift"). 187 C.F.R. § 205.403. Even! H7-1 Draft ER 15 Introduction 7/28/2010with these specific biotechnology-derived crops, ifsome residue ofthe biotechnology-derived plant material is laterfound in the organic crop (orfood produced from it), neitherthe crop (or food) northe organicfarm is in dangerof losing its organic status. No growerorseed producer has lost organic certification dueto inadvertenttransmission ofgenetic material from a genetically engineered crop. In the context ofthe genetic drift discussion, in the preamble ofthe NOP regulations, USDA emphasized that it is the use ofexcluded methods as a production methodthat is prohibited, not the mere presence ofa product ofexcluded method: It is particularly importantto rememberthat organic standards are process based. Certifying agents attest to the ability oforganic operations to follow aset ofproduction standards and practices that meet the requirements ofthe Act and the regulations. This regulation prohibits the use of excluded methods in organic operations. The presence ofadetectable residue ofa product ofexcluded methods alone does not necessarily constitute aviolation ofthis regulation. As long as an organic operation has not used excluded methods and takes reasonable steps to avoid contact with the products of excluded methods as detailed in their approved organic system plan, the unintentional presence ofthe products ofexcluded methods should not affect the status ofan organic product or operation.

## '9 The NOP calls fortesting only ifthere is "reason to believe" that a grower has used excluded methods'>o The preamble states that a "reasonto believe" may be triggered by situations such as a formal, written complaint to the certifying agent regarding the practices ofa certified organic operation; the proximity ofa certified organic operation to a potential source ofdrift; or the productfrom a certified organic operation being unaffected when neighboring fields orcrops are infestedwith pests." Thistesting provision does not establish a zero tolerance standard forthe presence of products ofexcluded methods in organically labeled food. Rather, it serves as a warning that excluded methods may have been used: "Any detectable residues of. . . a product produced using excluded methodsfound in or on samples during analysis will serve as a warning indicatorto the certifying agent.,,22 [Tlhese regulations do not establish a "zero tolerance" standard.

. . [A] positive detection ofa product ofexcluded methods would trigger an investigation by the certifying agentto determine ifa violation oforganic production or handling standards occurred. The presence ofa detectable

1965 Fed. Reg. at 80556. 207 C.F.R. § 205.670(b). 21 See 65 Fed. Reg. at 80629. 22 Id. at 80628. Event H7-1 Draft ER 16 Introduction 7/28/2010

### residue alone does not necessarily indicate use ofa product ofexcluded methods that would constitute aviolation ofthe standards."23 Only ifthe organic producer intentionally used excluded methods ofcrop production will that producer be subjectto suspension or revocation oforganic certification. There is no evidence that any organic grower has lost certification due to unintended presence ofGE material. 1.5.1 Non-GMO Project

### Working Standard The Non-GMO Project is a non-profit organization created by leading players in the organic industryto "offer consumers a consistent non-GMO choice for organic and natural products that are produced without genetic engineering or recombinant DNA technologies" (Non-GMO Project, 201Oa). The Non-GMO Project has created aworking standard to implement its goal. The standard sets action thresholds for "GMO" (GE) adventitious presence for certain products. Ifthese action thresholds are exceeded, the participant must investigate the cause ofthe exceedance and take corrective action (Non-GMO Project, 2010, p. 13). The standard sets a threshold of0.25% for GE material forthe presence ofGE traits in non-GE seeds (p. 28), and a 0.9% threshold for non-GE food orfeed (p.14). 1.5.2 Growth in organicand GE

### farming Expansion oforganic farming has succeeded at the same time as the growth of GE crops. Consumer demand for organically produced goods "has shown double-digit growth for well over a decade" and organic products "are now available in nearly 20,000 natural food stores and three offour conventional grocery stores." Organic products "have shifted from being a lifestyle choice for a small share ofconsumers to being consumed at least occasionally by a majority of Americans" (USDA ERS, 2009c). 

### 1.6 COEXISTENCE IN US AGRICULTURE 1.6.1 Coexistence

### and biotechnology Coexistence ofdifferentvarieties ofsexually compatible crops has long been a part of agriculture, especially in seed production, where large investments are made in developing new varieties and high seed purity levels are required by the Federal Seed Act implementing regulations. 24 

### The aspect ofcoexistence most relevantto this document is that related to specific methods ofcrop production. In this context, coexistence refers to the "concurrent cultivation ofconventional, organic, and genetically engineered (GE) crops consistent with

23 Id. 

### at 80632. 24 7 CFR §201 

### Event H7-1 

### Draft ER 17 

### Introduction 7/28/2010

### underlying consumer preferences and choices" (USDA Advisory Committee, 2008). The differences among these crops that are particularly relevant to coexistence in this ER are in the types ofbreeding methods (sometimes referred to as "genetic modifications") that are associated with each ofthe three types of crops. "Genetic engineering" is defined by APHIS regulations as "the genetic modification of organisms by recombinant DNA techniques.,,25 Recombinant DNA (rONA) techniques are discussed in Section 3.1.1 ofthis ER. While there are many ways to genetically modify a crop, the APHIS definition ofGE crops applies only to those developed using rONA techniques, which are among the more modern breeding methods. Organic crops are those produced in accordance with the requirements ofthe NOP, discussed in Section 1.5. Conventional crops are simplythose that are neither GE nororganic. They may be commodity crops (mass produced), or they may be identity preserved, with some characteristic tailored for a specific end user. Identity-preserved usually refers to a "specialty, high-value, premium or niche market" (Massey, 2002). Onetype ofidentity preserved productthat has been produced sincethe introduction ofGE crops is "non-GE;" however, there are no mandatory standards governing the use and/or marketing of "non-GE" products (USDA Advisory Committee, 2008). Farmers who wantto maximize their profitability must decidewhetherthe higher prices (premiums) they may receive for organic or identity-preserved crops are sufficient to offsetthe added managerial costs ofproducing these crops. As researchers have noted, "Although yields on organic farms are sometimes less than those ofconventional systems, price premiums make it an attractive option for growers looking for specialized markets and a higher-value product" (Ronald and Fouche, 2006). There is such a niche marketfor organic red beets and organic Swiss chard. However, no premium or niche market exists foreither conventional or organic sugar beets. 1.6.2 USDA 

### position on coexistenceand biotechnology It is USDA's position that all three methods ofagricultural production described above can provide benefits to the environment, consumers, and the agricultural economy (Smith, 2010b).

25 7 CFR §340.1 Event H7-1 

### Draft ER 18 Introduction 7/28/2010

### 1.6.3 Coexistence in US crop production Since the time GE crops were introduced in the US in the mid-1990s, organic markets have grown and expanded (Smith, 2010b, 

### p. 10). The USDAAdvisory Committee on Biotechnology and 21" Century Agriculture who reported that "coexistence among the three categories ofcrops is a distinguishing characteristic of U.S. agriculture, and makes it differentfrom some other parts ofthe world," expressed its beliefthat US agriculture supports coexistence, and recommended continued governmentsupport of coexistence (USDAAdvisory Committee, 2008). Among the Committee'sfindings:

• The U.S. is the largest producer ofGE crops in the world.
• The U.S. is one ofthe largest producers oforganic crops in the world.
• The U.S. is one ofthe largest exporters ofconventionally-grown, identity preserved, non-GE crops in the world.
• Some U.S. farmers currently are producing a combination oforganic, conventional, and GE crops on the same farm. Among the coexistence-enabling factors the Committee identified are the existing "legal and regulatory framework that has enabled different markets to develop" withoutforeclosing the ability of"participants in the food and feed supply chain to establish standards and procedures (e.g., not setting specific mandatory adventitious presence (AP) thresholds and having processbased ratherthan product-based organic standards)." At the sametime, developmentof practices and testing methods that allow for voluntary thresholds has also enabled coexistence (USDAAdvisory Committee, 2008). AsAPHIS has previously observed, "studies ofcoexistence of major GE and non-GE crops in North America and the European Union (E.U.) demonstrated thatthere has been no significant gene flow from GE crops and that GE and non-GE crops are coexisting with minimal adverse economic effects" (Smith, 201**~b,** pp. 11-12) (citing Gealy et. ai, 2007; Brookes and Barfoot, 2003; Brookes and Barfoot, 2004(a) and (b), and Walz 2004)). In addition, "the agricultural markets and local entities have addressed coexistencethrough contractual arrangements, management measures, and marketing arrangements. This market-based approach to coexistence has created economic opportunities for all kinds ofproducers ofagricultural products." 

### (ld. p.9). RRSB is one offifteen glyphosate-tolerant events previously deregulated by USDA. 

### See APHIS, EPA, Petitions ofNon-Regulated Status Granted 

### or Pending byAPHIS as of February 2, 2010, http://www.aphis.usda.gov/brs/not_reg.html.

Event H7-1 Draft ER 19 Introduction 7/2812010

### 1.7 ROLE OF THE NATIONAL ACADEMIES IN AGRICULTURAL BIOTECHNOLOGY The analyses in this ER are based on published, peer-reviewed scientific papers; federal government assessments; assessments from international agencies; information from specialists from many universities; data collected by Monsanto/KWS under controlled conditions; and information from other relevant sources. One resource used forthis ER is the National Academies (NA), a private, non-profit institution that advises the nation on scientific and technical matters. It consists ofthe National Academy ofSciences (NAS), the National Academy of Engineering, the Institute of Medicine (1M) and the National Research Council (NRC) (NA, 2010). Scientists, engineers and health professionals are elected by their peers to the academy and serve pro bono. 

### Reports are prepared by committees ofmemberswith specialized expertise and reviewed by outside anonymous experts (Alberts, 1999). The NA has been active in studies related to agricultural biotechnology sincethe 1970s, works cooperatively with federal agencies, and its reports have provided guidance and recommendations for process improvementto regulatory agencies (Alberts, 1999). The NRC 1989 guidelinesforfield testing ofgenetically engineered organisms were used as the basis for agency procedures forfield trials (Alberts, 1999; NRC, 1989). In studies in 1987 and 2000 the NRC emphasized thatthe characteristics ofthe modified organism should be the object ofa risk assessment, and notthe methods by which the modifications were accomplished; and thatthe risks associated with recombinant DNA techniques are the same in kind as risks from other types ofgenetic modification (NRC, 1987; NRC, 2000). This position was re-iterated in a 2004 study prepared jointly by the 1M and the NRC. Whether such compositional changes result in unintended health effects is dependent on the nature ofthe substances altered and the biological consequences ofthe compounds. To date, "no adverse health effects attributed to genetiC engineering have been documented in the human population" (1M/NRC, 2004, p. 8). In a 2002 report, the NRC "found that the current standards used by the federal governmentto assure environmental safety oftransgenic plants were higherthan the standards used in assuring safety ofother agricultural practices and technologies" (NRC, 2002). The NRC reports that, while biotechnology is notwithout risk, since the first commercial introduction oftransgenic plants, "biotechnology has provided enormous benefits to agricultural crop production" (NRC, 2008). NRC's latest report on biotechnology in agriculture evaluates the impact ofgenetically engineered crops on farm sustainability. The authors concluded that an understanding of impacts on all farmers will help ensure that GE technology contributes to sustainability and that Event H7-1 Draft ER 

### 20 Introduction 7/28/2010

### commercialized GE traits to date, when used properly, "have been effective at reducing pest problems with economic and environmental benefitto farmers" (NRC, 2010). 1.8 

### ALTERNATIVES CONSIDERED In addition to the alternative of partial deregulation or other administrative action implementing the interim conditions (Alternative 2), this ER considers the alternative of full regulation (Alternative 1). 1.8.1 Alternative 1 - No Action (full regulation) In conducting NEPA review, agencies consider a No Action alternative, which provides a baseline againstwhich action alternatives can be evaluated. This ER identifies the No Action alternative as a return to full regulation
- orthe status quo 

### existing when the petition for deregulation ofevent H7-1 was initially submitted. Underthis alternative, the introduction of event H7-1 lines ofglyphosatetolerant sugar beets would be fully regulated and would require permits issued or notifications acknowledged by APHIS until APHIS completes its EIS and issues a Record ofDecision (ROD) regarding whetherto deregulate H7-1 lines ofglyphosate tolerant sugar beets. For purposes ofthis analysis, we assume that Alternative 1would not involve widespread event H7-1 sugar beet cultivation, and instead would contemplate a return to conventional sugar beet crops orto crops otherthan sugar beet. Note: 

### As indicated above, the status quo 

### is event H7-1 sugar beets comprising 95 percent ofthe U.S. sugar beet crop. 1.8.2 Alternative 2
- Partial Deregulationwith Interim Conditions Underthis alternative, the introduction ofevent H7-1 lines ofglyphosatetolerant sugar beets would be allowed under interim conditions until APHIS completes its EIS" issues a Record of Decision, and that decision takes effect
-- currently anticipated for mid-2012 (Smith, 2010b, p. 

### 8).

Event H7-1 Draft ER 21 Introduction 7/28/2010

### AFFECTED ENVIRONMENT

This section describes the affected environment and provides other contextual information for an understanding ofthe environmental consequences analyzed in Section 3. 

### 2.1 SUGAR BEET CHARACTERISTICS AND USES Sugar beet (Beta vulgaris L.) 

### is a biennial plantthatwas developed in Europe in the 18th centuryfrom white fodder (animal feed) beets. Sugar reserves are stored in the sugar beet root during the first growing season for an energy source during overwintering. The roots are harvested for sugar at the end ofthe first growing season but plants that overwinter in a mild climate will produce flowering stems and seed during the following summerand fall. Sugar beet roots will notsurvive the winter in any ofthe growing regions except California (Cattanach et ai, 1991).). Pollination. The sugar beet is cross-pollinated (pollination occurs between plants ratherthan within single plant) by wind (Cattahach et ai, 1991). Climate. Sugar beets have adapted to a very wide range ofclimatic conditions. Sugar beets primarily are a temperate zone crop produced in the Northern Hemisphere at latitudes of30 to 60 0

### N. The sugar beet plant grows until harvested or growth is stopped by a hard freeze. Sugar beets primarily growtops until the leafcanopy completely covers the soil surface in afield. This normallytakes 70 to 90 days from planting. Optimal daytimetemperatures are 60 to 80°F for the first 90 days ofplant growth. Regions with long day length are most suitable for sugar beet growth. The mostfavorable environment for producing a sugar beet crop from 90 days after emergence to harvestis bright, sunny days with 65 to 80°Ftemperatures followed by nighttime temperatures of40 to 50°F. These environmental conditions maximize yield and quality in a sugar beet crop. Sugar beets are successfully produced under irrigation in areas with very low rainfall and in regions relying on natural rainfall (Cattanach et ai, 1991). Products. Sugar beets contain from 13 to 22 percent sucrose. Sugar beet pulp and molasses are proceSSing by-products used as feed supplements for livestock. These products provide required fiber in rations and increase the palatability offeeds. Molasses by-products from sugar beet processing are used in the alcohol, pharmaceuticals, and bakers' yeast industries (Cattanach et ai, 1991).

Event 

### H7-1 Draft ER 

### 22 Affected Environment 7/28/2010

### 2.2 ACCEPTANCE OF EVENT H7-1 SUGAR BEETS Event H7-1 sugar beets were first available for commercial production in 2007 (Lilleboe, 2008). In the 2009/10 

### crop year, event H7-1 varieties accounted for about 95 percent ofplanted area, up from about 60 percent in 2008/09 

### (USDA ERS, 2009a). Since, as noted in Section 1, no event H7-1 sugar beets have been grown in California and California represents approximately 

### 3 percent ofUS sugar beet production (Table 2-1),98 percent ofthe planted 2009/2010 

### sugar beet crop in the remaining US sugar beet regions was event H7-1.



### T bl 21 US S

a e 

# - ugar 

### B tP d 

# r ee 

### ro uc lon, 2009/2010 

### S Region/State 1,000 shorttons Great Lakes Michi[.1an 3,318 Total 3,318 Upper Midwest Minnesota 10,641 North Dakota 4,796 Total 15,437 Great Plains Colorado 963 Montana 1,001 Nebraska 1,294 Wyomin[.1 678 Total 3,936 Northwest Idaho 5,591 Oregon 395 Total 5,986 FarWest California 886 Total 886 Source: USDA ERS, 2010a, Table 14



### Event H7-1 

### Draft ER 23 

### eason 

### Percent of US Total

11

52

13

20

3

Affected Environment 7/28/2010

### 2.3 SUGAR BEET ROOT PRODUCTION 2.3.1 US Production 

### by regions 

### The US is among the world's largest sugar producers. Unlike most other producing countries, the US has both large and well-developed sugarcane and sugar beet industries. Since the mid1990s, sugarcane has accounted for about 45 percent ofthe total sugar produced in the US, and sugar beets for about 55 percent ofproduction. Since 1961, planted sugar beet acreage has fluctuated within the range of 1.1 

### million (low in 1982)to 1.6 million (high in 1975) (USDA NASS 2010a). Annual cash receipts for sugar beets in the US in the pastfew years have ranged up to $1.5 billion (USDA ERS, 2009b). Figure 2-1 shows the five major US sugar beet producing regions, along with 2008 production by county.
Great 

### Lakes. Great Lakes sugar beet production, now entirely in Michigan, occurs in the flat area around Saginaw Bay. Sugar beets grown in the Great Lakes region do not require irrigation. The Great Lakes region also includes Ohio, where sugar beets were last produced in 2004. Upper Midwest. 

### The Upper Midwest is the largest sugar beet production region in the US, with the majority ofthis production in the Red RiverValley. The Red Riverflows north into Canada and forms most ofthe North Dakota-Minnesota border. Itflows through a broad, flat valley formed by an ancient glacial lake. The Minnesota RiverValley, another broad, flat glacial valley that crosses southern Minnesota and is almost continuous with the Red River Valley, is also a large production area. Irrigation is uncommon in the Red River/Minnesota River Valleys (Ali, 2004). There is another, much smaller Upper Midwest production area along the Montana border of North Dakota, in the valley ofthe Yellowstone River and its tributaries. Great Plains. 

### The Northern Great Plains region includes production areas in northern Wyoming and southern Montana. The majorsugar beet growing areas in the Northern Great Plains are the sandy loam soils along the Yellowstone River and itstributaries (Mikkelson and Petrof, 1999, p. 2). The Southern Great Plains subregion includes growing areas in western Nebraska, southeastern Wyoming and northeastern Colorado, primarily in the valley ofthe Platte River and its tributaries. All Great Plains sugar beet production requires irrigation (Thomas etai, 2000, p. 1; Mikkelson and Petrof, 1999, p. 3; McDonald et ai, 2003, p. 2).

Event H7-1 

### Draft ER 

### 24 Affected Environment 7/28/2010Tons ! Not Estimated**i-~',** < 100,000 

# I ······· 100,000

- 249,999 

### i 250,000

- 499,999 

### mil! 500,000

- 749,999

. 750,000

- 999,999 1,000,000+

.. Sugar beet processing facility, 2010 U,S. Department ofAgriculture, National Agricultural Stalislias Service 

### Sugarbeets 2008 Production by County

Figure 2-1. US sugar beet regions and 2008 county production.
Event H7-1 Draft ER 25 ,c t! [, r 

# USD'A**.",,([mlllliN'.~.** :t-\. .;:**!ii~ Clr'~1'** 

## ~ 

# -'

Affected Environment 7/28/2010The Great Plains region previously included New Mexico and Texas, where sugar beets were last harvested in 1997.
Northwest. Most production in the Northwest region is in the sandy loam soil ofthe Snake River Valley in Idaho. This area also requires irrigation (Traveller and Gallian, 2000, p. 1). In addition, production occurs in southeast Washington state, east ofthe Cascade mountains.
FarWest (California). The only sugar producing area in California is in the Imperial Valley in the far southern end ofthe state, where the only remaining sugar processing plant in California exists. Production occurred in the Central Valley (nearthe middle ofthe state) through 2008; however, the last processing plant in this area closed in 2008. As recently as the 1990s, nearly 30 percent ofsugar beet production was in the Central Valley; there were also small areas of production in coastal counties (but production in those regions no longer exist) (California Beet Growers Association, 1998, p.1). US production forthe 2009/2010 season (harvested in 2009 and processed in 2009/2010) is shown in Table 2-1. In 2010, sugar beetwas planted on 1.2 million acres (USDA ERS, 2010a, Table 14). Sugar beet production by county from 2005 to 2008, including acres planted, acres harvested, yield per acre, total yield and sucrose percent, is tabulated in Appendix D.
The distribution of planted acreage by state is shown in Figure 2-2.

illMN m! NO ill 10 illMI o;1NE



### MT Wy 

## co CA OR 

### Figure 2-2. 2010 distribution by state ofacres planted in sugarbeet Source: USDA NASS, 2010a

Event H7-1 Draft ER 26 Affected Environment 7/28/2010

### 2.3.2 Grower-processor relationships Sugar beet production, more than most crops, requires close coordination between the grower and the processor. The crop is oflittle value without a processorto extractthe sugar, and a sugar processing facility cannot stay in business without a reliable supply ofbeets (Kaffka and Hills, 1994, p. 2). While a type ofsyrup can be made on a small scale, home garden production ofsugarwould be impractical; processing cannot be duplicated successfully in a home kitchen (California Beet Growers Association, 1998, p. 3). Sugar beets are 75 percentwater and expensive to transport long distances (Michigan Sugar Company, 2010a). For economic reasons, sugar beets are typically grown within 60 miles ofa processing facility, but may be grown up to 100 miles away (Western Sugar Cooperative, 2006a). Locations ofthe 22 processing facilities in operation in 2010 are shown in Figure 2-2. While existing facilities have been upgraded, no new currently operating processing facilities have been built in the US since 1975. An estimated costforan average-sized newfacility in 1991 was $100 million (Cattanach etai, 1991, p. 16). The costwould be substantially highertoday due to inflation and other factors. Sugar beet production and processing in the US is done almost entirely by grower-owned cooperatives. The cooperatives own the processing facilities and the sugar beetfarmers are members ofthe cooperatives. The members own shares ofstock that require them to grow a specified acreage ofbeets in proportion to their stock ownership in the cooperative and guarantee processing fortheir beets. US companies are summarized by regions below. Cooperatives are owned by growers Who are principally family farmers. According to the 2007 US Census ofAgriculture, over4,000 farms growsugar beets (USDA ERS 2009b). Great Lakes. Michigan Sugar Company, the third-largest sugar beet processor in the US, processes all the sugar beets in the Great Lakes region, as well as beets from Ontario, Canada

.. The cooperative has over 1,000 grower-shareholders who growsugar beets on 150,000 acres each year. The sugar beets are processed into sugar atfactories in Bay City, Sebewaing, Caro and Croswell. The cooperative employs 450 year-round and 1,200 seasonal employees, generates nearly $400 million in direct economic activity annually in the local communities in which it operate, and annually produces nearly one billion pounds ofsugar (Michigan Sugar Company, 201**~b).** 

### Upper Midwest. Three cooperatives operate in the Upper Midwest. American Crystal Sugar Company, the largest sugar beet producer in the US, is owned by approximately 3,000

Event H7-1 Draft 

### ER 27 Affected Environment 7/28/2010

### shareholders who raise 500,000 acres ofsugar beets in the Red RiverValley of Minnesota and North Dakota. The company operates five sugar processing facilities in the Red River Valley: three in Minnesota (Crookston, East Grand Forks and Moorhead) and two in North Dakota (Drayton and Hillsboro). American Crystal also operates a sugar beet processing facility in eastern Montana at Sidney, underthe name Sidney Sugars Incorporated. American Crystal's fiscal year 2009 Red River Valley crop averaged 25.4tons per acre with 17.6 percent sugar content.. In 2009, the company produced approximately 3 billion tons ofsugarand 681,000 tons ofagri-products (molasses and pulp) (American Crystal Sugar Company, 2009). Minn-Dak Farmers Cooperative, with 450 shareholders, operates a processing facility in Wahpeton, in the farsoutheast corner of North Dakota. Minn-Dak also operates a yeastfactory, which uses molassesfrom sugar beet processing (Minn-Dak Farmers Cooperative, undated). The Southern Minnesota Beet Sugar Cooperative has approximately 600 shareholders who farm 120,000 acres, and operates a processing facility near Renville, Minnesota (Southern Minnesota Beet Sugar Cooperative, 2010).

Great Plains. The Western Sugar Cooperative, with 135,000 acres and five factories, processes most ofthe Great Plains sugar beet. Processing facilities are in Fort Morgan, Colorado; Billings, Montana; Scottsbluff, Nebraska; and Lovell and Torrington, Wyoming. Wyoming Sugar Beet Company, LLC is not a cooperative, butworks through the Washakie Farmers Cooperative to acquire beets for its plant in Worland, Wyoming (Boland, 2003).

Northwest. The Amalgamated Sugar Company LLC processes all the sugar beet in the Northwest region. Amalgamated is owned by Snake River Sugar Company, a grower-owned cooperative, and is headquartered in Boise, Idaho with processing plants in Paul, Twin Falls, and Nampa, Idaho (Snake River Sugar Company, 2009).

FarWest (California). Spreckels Sugar Company, a subsidiary ofSouthern Minnesota Beet Sugar Cooperative, operates a sugar beet processing facility in Brawley, California, in the Imperial Valley. Yields in the Imperial Valley are higherthan anywhere else in the US, averaging approximately 40 tons per acre (Spreckels Sugar, 2009).

Event H7-1 Draft ER 28 Affected Environment 7/28/2010

### Tillage systemsare defined bythe amountofcrop residue remaining on the soil. Conventional tillage systems leave less than 30percentof crop residue remaining on the soil whenplantinganothercrop. Conservation tillageleaves 30 percentormore ofthe previous crop residue covering the soil when plantinganothercrop. Reducedtillageleaves 15 to 30percentoftheprevious crop residue covering the soil when plantinganothercrop. Mulch tillage disturbs the soil priortoplanting

. .Tillage tools such as chisels, fieldcultivators, disksorblades are used. Weed controlis accomplished with herbicides and/orcultivation. No Tillleaves the soil undisturbed. With strip tillage, 

### a specific type 

### ofconservation tillage, tillage is confinedto narrow strips where seeds willbe planted. Strip tillage is usually done in the fall. The loosened soilcreates 

### a ridge 3 to 4 inches high, which improves soil drainage and warming. By spring, it usuallysettles down to 1or2 inches high, andafter planting the fieldis flat. Sources: AI." 2004, p. 32; 

### 2.3.3 Sugar beetcUltivation practices Seed bed preparation and tillage. The objectives of seedbed preparation are to manage crop residue (the leftovervegetative matterfrom the previous crop), minimize erosion, improve soil structure, and eliminate early season weeds. Tillage, which can be done in fall and spring, can help improve soil structure and eliminate early weeds, but tillage can also increase erosion. Notill, strip tillage in previous crop residues, and other conservation tillage systems (see definitions at left) require more planning and better management (Cattanach etai, 1991). In addition to the reduced tillage methods (noted at left), no-till productions systems do not have any associated tillage where weed control is entirely through chemical means. A survey conducted in 2000, before event H7-1 sugar beets were available, found that use ofconventional tillage for sugar beet production varied by region from 64 percent ofacreage in the Red RiverValley in the Upper Midwestto 96 percent ofacreage in the Northwest (California was not included because there was too little data). Growers in the Red River Valley reported using reduced tillage on 16 percent ofsugar beet acres and mulch tillage on 20 percent (Ali, 2004). Because weeds can be effectively controlled with glyphosate applications, event H7-1 sugar beets may be grown with less tillage (NRC, 2010, p. 6; Duke and Cerdeira, 2007, p. 3; Wilson, 2009).

In the Idaho (Northwest), priorto glyphosatetolerant sugar beets conventional tillage was essential forweed control, minimizing soil erosion and improving soil structure (Ali, 2004; Traveller and Gallian, 2000, p. 1). Sincethe introduction ofevent H7-1, some farmers in the Northwest have switched to striptillage and have reported reduced fuel and labor costs and

Event 

### H7-1 Draft ER 

### 29 Affected Environment 7/28/2010reduced wind erosion (Ulleboe, 2008). Researchers in Idahofound thatwhile conventional tillage was necessary forweed control with conventional beets, the practice has littleto no benefitwith g[yphosate-to[erant sugar beets (Miller and MiI[er, 2008). [n much ofthe Great Plains region, conventional sugar beets were cultivated using conservation tillage systems; however, deeptil[age, which is used to improve drainage, was utilizedto help reduce the risk ofsoil borne diseases (main[y the beet necroticyellow vein virus causing rhizomania) (McDona[d etai, 2003, p.2). Farmers in the Great Plains have reported that strip tilling and event H7-1 have "been a great marriage," with strip tilling resulting in reduced wind erosion, reduced irrigation requirements and fuel and time savings (U[[eboe, 2010). Michigan Sugar Company recommends conservation til[age practices to help control erosion resulting from strong early spring wind in the Great Lakes region (Michigan Sugar Company, 2009, p. 2). However, since the introduction ofthe event H7-1 this growing region has the option of implementing varying methods ofreduced tillage systems.

Recent studies by North Dakota State University have found that since the introduction ofevent H7-1, strip tiI[age is a viable option for sugar beet production that reduces fuel and fertilizer costs and susceptibility to wind erosion (Overstreet etai, 2009). A memberofthe Minn-Dak Farmers Cooperative, who farms about 1,100 acres ofsugar beets annually, has found that instead ofthree post-emergence til[age trips across the fields, with event H7-1 he now needs "litt[e to no tillage post-emergence" (Mauch, 2010, p. 3). Planting and harvestingtimes. [n all regions exceptthe FarWest (California), sugar beet root crops are planted in early spring (March through May, depending on latitude and location) and harvested in fall (Septemberthrough November, also varying with regions) (McDona[d et ai, 2003; Mikke[son and Petrof, 1999, p 3; Michigan SugarCompany, 2010b). [n the Imperial Valley in California, sugar beets are planted in September and October and harvestedfrom April to Ju[y (California Beet Growers Association, 1999, p. 1). Crop rotations. Sugar beets tend to be grown with other crops in three- to five-year rotations, although sometimes two years is used. The rotation results in improved soil fertility, fewer problems with diseases, and improved yields and quality ofbeets. The impact ofcertain soil borne diseases, nematodes (parasitic, microscopicworms) and weeds are minimized through

Event H7-1 Draft ER 

### 30 Affected Environment 7/28/2010

### crop rotations (Mikkelson and Petrof, 1999, p. 3; USDA ERS, 2009b, p. 2; Hirnyck et ai, 2005, p. 13). To assess the likelihood thatthe rotational crops planted after event H7-1 sugar beetwould be another glyphosate-tolerant crop an analysis of rotations to other crops was conducted and included in the petition (Schneider, 2003, Table VII-13). This rotational crop table has been updated with crop information from the 2007 planting season and includes projected acreage for recently commercialized glyphosate-tolerant crops (Table 2-2). 2.3.4 Sugar beet bolters and volunteers Bolting. Sugar beet, ifleftto grow in atemperate climate, is a biennial plantthat produces an enlarged root the firstyear and flowers in the second year. Typically, the plant is induced to flowerthrough a process called vernalization that occurs during prolonged exposure to cooler temperatures. Occasionally sugar beets will bolt (produce a seed stalkthat may ultimately flower) in theirfirst year ofproduction; however, with breeding, bolting tendency has been reduced. Much effort has gone into producing sugar beets that resist bolting, and today's varieties show little bolting (DECO, 2001, p. 15). No difference in bolting characteristics would be expected between conventional and event H7-1 sugar beets, as the introduction ofthe glyphosate toleranttrait does not affectthe bolting characteristics ofthe sugar beet. In the 2000-2001 variety field trials with lines containing event H7-1 reported in the petition, six of 12 event H7-1 sugar beet varieties had 0.00 percent bolters; for those varieties with bolters, the percentages were 0.03 percentfor three; 0.06 percentfor two, and 0.19 percentfor one. All entries were established as six row plots forty feet in length with six replications at each location in 2000, and four replications at each location in 2001 (Schneider, 2003, Table VI-9). Darmency et al report bolting percents now as low as 0.01 percent (2009, p. 1090). While Darmency etal were referring to conventional sugar beets, event H7-1 would not affect bolting characteristics, and breeders continue to selectfor low rates of bolting. For bolting to occur, the plants first require exposure to temperatures around 40 to 42 degrees F (others report 34 to 39 degrees F in the 4 to 5 leafstage; conditions are variety-dependent), followed by exposure to increasing day length (12 hours or more). Varieties differ in their sensitivity to bolting, with easy bolting lines requiring only a fewto 1000 hours ofexposureto low temperatures, while bolting-resistant lines may require 2000 hours or more. Beets can devernalize when exposed to high temperatures (DECO, 2001, p. 15).

Event H7-1 Draft ER 31 

### Affected Environment 7/28/2010

### Bolting depletesthe root ofsimple sugars, translocating this stored energy into the aboveground biomass, making the rootwoody and worthless as a source ofsugar. Bolters are taller than the rest ofthe crop. Thus, bolters are effectively weeds within a sugar beetfield. The woody roots that resultfrom bolters can damage harvesting and processing equipment (Ellstrand, 2003, p. 5-7). Forthese reasons, growers remove bolters. A bolter is evident in a field weeks before the seed stalkwould flowerto produce pollen or seed. Thus, stewardship can be 100% successful in eliminating any small probability offlowering.

Event H7-1 

### Draft ER 

### 32 Affected Environment 7/28/2010Table 2-2. A

State
CA

CO

ID

MI

MN

Event H7-1 Draft ER Rotational cropsfollowing US sugar beet production and an estimation of rotational crops as Roundup Ready® crops \all acreages are expressea as 1uuu acres) 8 C 0 E F Percent of Total MajorCrops TotalAcreage Rotational Rotational SugarBeet That Follow ofRotation Crop Crop Acres

Acres1 Sugar Beet Crop in States1 Rotated Following In Rotatlon2 Following Sugar Beee SUf:lar Beee 50 Barley 130 7.7% 10 Dry Beans 92 5.4% 5 Durum 95 10.5% 10 Oats 260 3.8% 10 Spring Wheal 530 2.8% 15 Total: 1,107 Total: 50 44 Barley 85 5% 4 Corn 1200 3% 31 DryBeans 92 8% 7 Potato 78 3% 2 Total: 1,455 Total: 44 212 Alfalfa 730 1.5% 11 Barley 730 4.4% 32 Corn 190 3.2% 6 Dry Beans 95 4.2% 4 Spring Wheat 530 30.0% 159 Total: 2,275 Total: 212 180 Corn 2.250 5.2% 117 Dry Beans 270 6.7% 18 Soybean 2.050 2.2% 45 Total: 4,570 Total: 180 505 Barley 210 23.8% 50 Soybean 7.200 4.9 354 Spring Wheat 2,000 5.1% 101 Total: 9,410 Total: 505



### 33 G H Percent Percent Roundup Rotational Ready® Crop ofTotal Rotational Sugar Beee Crop Optlon5,6 20% NA 10% NA 20% NA 20% NA 30% NA

10% NA 70% 52% 15% NA 5% NA
5% 500 /0 15% NA 3% 52% 2% NA 75% NA
65% 52% 10% NA 25% 91%
10% NA 70% 91% 20% NA I Acreage of Roundup Ready® Rotational Crop Option7 0 0 0 0 0 Total: 0 0 16 0 0 Total: 16 6 0 3 0 0 Total: 9

61 0 41 Total: 102 0 322

0 Total: 322 J K I Percentof Estimated Sugar Beet Percentage of

Acres Roundup Preceding Ready® Crops,

Major RotationsB as Major Rotationss

4.52% 0%

3.02% 1.10%

9.32% 0.40%

3.94% 2.23%

5.37% 3.42%

Affected Environment 7/28/2010Table 2-2. A

State

MT

ND

NE

WY

Overall

Event H7-1 Draft ER Rotational crops following US sugar beet production and an estimation ofrotational crops as Roundup Ready® crops (all acreages are expressed as 1UUO acres) B C D E F Percentof Total MajorCrops Total Acreage Rotational Rotational That Follow Crop Crop Acres Sugar Beet Sugar Beet of Rotation Rotated Following

Acres' Crop in States1 In Rotation2 Following Sugar Beee SugarBeee 5B Sarley 1.200 2.4% 29 Corn 65 21.5 % 14 Dry Beans 27 33.3% 9 Spring Wheat 3.750 0.2% 6 Total: 5,042 Total: 58 265 Barley 1.600 2.5% 40 Corn 1.230 3.3% 40 Durum 2.100 0.6% 13 Soybean 2,670 4.0% 106 Spring Wheat 6,900 1.0% 66 Total: 14,500 Total: 265 57 Corn 8,400 0.3% 29 Dry Beans 1B5 11.9% 22 WinterWheat 1.650 0.4% 6 Total: 10,235 Total: 57 40 Barley 90 24.4% 22 Corn BO 12.5% 10 Dry Beans 32 12.5% 4 Sugar Beet 40 10% 4 Total: 242 Total: 40 1,411 Ifalfa 730 1.5% 11 Barley 4.045 4.6% 186 

## porn 13.415 1.8% 247 Dry Beans 793 8.7% 69

34 G H Percent Percent Roundup Rotational Crop ofTotal Ready® Rotational Sugar Seee Crop Option5,6 50'

Yo NA 25% 52% 15% NA 10% NA

15% NA 15% 52% 5% NA 40% 91% 25% NA

50% 52% 40% NA 10% NA

55% NA 25% 52% 10% NA 10% 95%

0.8% 50% 13.2% NA 17.5% 52% 4.9% NA I Acreage of Roundup Ready® Rotational Crop Option7
0 7 0 0 Total: 7 0 21 0 96 0 Total: 117 15 0 0 Total: 15 0 5 0 2 Total: 7 6 0 12B 0 J K Percent of Estimated Sugar Beet Percentage of

Acres Roundup Preceding Ready® Crops

Major RotationsB as Major Rotations9

1.15% 0.14%

1.83% 0.81%

0.56% 0.15%

16.53% 2.89%

Affected Environment 7/28/2010Table 2-2. Rotational crops following US sugar beet production and an estimation ofrotational crops as Roundup Ready® crops (all acrea es are expressed as 1000 acres) A B C 0 E F G H I J K Percentof Percent Acreage of Percentof Estimated Total Major Crops Total Acreage Rotational Rotational Percent Roundup Roundup Sugar Beet Percentage of State Sugar Beet That Follow of Rotation Crop CropAcres Rotational Ready® Ready® Acres Roundup Acres1 Sugar Beet Crop In States1 Rotated Following Crop ofTotal Rotational Rotational Preceding Ready® Crops In Rotatlon2 Following Sugar Beee Sugar Beet4 Crop Options,s Crop Optlon7 Major as Major Sugar Beee RotationsD Rotations9 Durum 2195 1.0% 23 1.6% NA 0 Oats 260 3.8% 10 0.7% NA 0 Potato 78 2.6% 2 0.1% NA 0 Soybean 11,920 4.2% 505 35.6% 91% 460 Spring Wheat 13,710 2.5% 347 24.6% NA 0 Sugar Beet 40 10% 4 0.3% 95% 2 \'\AnterWheat 1,650 0.4% 6 0.4% NA 0 StateTotals Total: Total: Total: 2.89% 1.22% 48,836 1,411 596 Legend: NAdenotes not applicable. 1 Acreage planted ofthe specific crop is based on 2002 planting data (USDA-NASS. 2003). 2 Rotated crops and acreage following sugar beet production are based on communications from individual local experts. i.e., university agronomists, USDA-ARS and Monsantofield personnel. 3 Column E obtained by dividing Column F by Column D and multiplying by 100. 4 Column G obtained by dividing Column F by Column B and multiplying by 100. 5 Roundup Ready® rotational crop penetration rates for corn and soybean are based on 2007 plantings (USDA-NASS, 2007); penetration rates for alfalfa are assumed to be 50% for the purpose ofthis assessment to represent potential future plantings. 6 Roundup Ready® rotational crop penetration rates forcorn and soybean are based on 2007 plantings (USDA-NASS, 2007); penetration rates forsugar beet are assumed to be 95% for the purpose ofthis assessmentto represent potential future plantings. 7 Column I obtained by multiplying Column F by Column H. B Column J obtained by dividing Column B by Column D Total and multiplying by 100. g Column K obtained by dividing Column I Total by Column D Total and multiplying by 100.

Event H7-1 Draft ER 35 Affected Environment 7/28/2010In the Imperial Valley in California, sugar beets are planted in September, growthrough the winter months, and are harvested the following April through June. Vernalization occurs more frequently in the Imperial Valley than in the other US regions, where sugar beet is planted in the spring and harvested in the fall. Ifthe winter in the Imperial Valley is unusually cold and harvesting is delayed, some bolters can develop (California Beet Growers Association, 1998, pp. 3-5; Bartsch et ai, 2003). Sugar beetvolunteers. Volunteers are plants from a previous crop that are found in subsequent crops. In most crops, volunteers growfrom seeds. Ifsugar beet bolters are allowed to go to seed in certain more temperate climates, the seed may sprout and cause volunteers in lateryears, in other crops. Groundkeepers are a type ofvolunteer derived from vegetativetissue (small roots) left in the field after harvest, which can grow in the next season if not controlled. In most parts ofthe US where sugar beets are grown, beet roots would not be expected to survive the winter, and therefore groundkeeperswould be oflittle concern (Panella, 2003). Cattanach et aI., who focused on production in the northern plains and upper Midwest (including North Dakota and Minnesota), reported that sugar beets could notsurvive the winter in these areas (1991). Sugar beets are not good competitors with other crops. Anythat survive can be reservoirs for beet diseases and good management practices dictatethatthey be removed (Kaffka, 1998). 

### 2.4 GENE FLOW Definition. Gene flow has been defined as the "incorporation ofgenes into the gene pool of one populationfrom one or more populations" (Futuyma, 1998). Geneflow is a basic biological process in plant evolution and in plant breeding, and itselfdoes not pose a risk (Bartsch et ai, 2003; Ellstrand, 2006, p. 116). Howgeneflow is addressed in this document. In this section we provide some background information on geneflow, which is included in several different discussions of impacts, as follows:

• Potential for geneflowfrom event H7-1 sugar beet crops to conventional sugar beet crops (Section 3.3)
• Potential for gene flow from event H7-1 sugar beetto crops to organic sugar beet crops (Section 3.4)
• Potential forgeneflowfrom event H7-1 sugar beet crops to other Beta crops (Section 3.5) Event H7-1 Draft ER 36 Affected Environment 7/28/2010

### • Potential forgene fiow from event H7-1 sugar beet crops to other Beta 

### seed production areas (Section 3.6)
• Potential forgene fiow from event H7-1 sugar beet crops to native beets (Section 3.7)
• Potential for gene fiow from event H7-1 sugar beets crops to weed beets (Section 3.8)

• Potential forgene flow from event H7-1 sugar beet to any ofthe above receptors, in sugar beet seed production (Section 3.9) Hybridization. In plant biology, when genefiow occurs between individuals from genetically distinct populations and a new plant is formed, the new plant is called a hybrid (Ellstrand, 2003, p. 10). Hybridization is usually thought ofas the breeding ofclosely related species resulting in the creation ofa plant that has characteristics differentfrom either parent. Usuallythis occurs through deliberate human efforts; however, it can also occur indirectlyfrom human intervention, or in nature. For example, when plants are moved to a new environment (with orwithout human intervention), they may hybridize with plants ofa closely related species orsubspecies in that new location. For natural hybridization to occur between two distinct populations, the plants from thetwo populations mustfiower atthe same time, they must be close enough so that the pollen can be carried from the male parent to the female parent, fertilization mustoccur, and the resulting embryo must be able to develop into aviable seed that can germinate and form a new plant (Ellstrand, 2003, pp. 11-13). Introgression. Hybridization may occur in one generation, but in most cases, does not continue on its own. Ifit does, and stable new populations result, the process is called introgression. For introgression to occur, hybridization of offspring back with the parenttypes (backcrossing) must occur several times. Because hybrids ofdistantly related species may not produce viable seed, introgression is much less common than hybridization. For example, in studies done with canola and aweedy relative, backcrossing from the hybrids to the weeds occurred at one-hundredth to one-thousandth the rate ofthe original hybridization (reported in Stewart, 2008, p. 2). Nevertheless, when weed species are introduced to new areas, there is the potential that those introduced plants may hybridize with other closely related species. Novel hybrids therefore may be created. In addition, novel hybrids may be created through back-crossing (Le. introgression) with parent species which may change the native species with non-native genetic material. Invasiveweeds can resultfrom hybridization events, which mix genetic material potentially producing awide array ofgenotypes. Some ofthese genotypes may exhibit increased invasive properties (USDA ARS, 2008).

Event H7-1 Draft ER 37 Affected Environment 7/28/2010Characteristics thatfavor natural hybridization between two populations when the above requirements are met include (Mallory-Smith and Zapiola, 2008, p. 429):

• Presence offeral populations (domestic populations gonewild) and uncontrolled volunteers
• Presence ofa high numberof highly compatible relatives

• Self-incompatibility

• Large pollen source
• Large amounts ofpollen produced

• Lightweight pollen

• Strong winds (wind pollinated)

• Large insect populations (insect pollinated)

• Long pollen viability Feral populations are discussed in Section 2.9.4. Volunteers, which are plantsfrom a previous crop that are found in a later crop, are common in agriculture and were discussed in Section 3.2.3. Highly compatible relatives ofsugar beets present in the US include red table beets, spinach (or leaf) beets, and Swiss chard (discussed in Sections 3.5, 3.6 and 3.9); and weed beets ofthe same

### or closely related species (discussed in Section 3.8). Sugar beets and other members ofthe species B. vulgaris are self-incompatible; that is, fertilization does not occur between the male and female parts on the same plant. Selfincompatible plants must outcross: forfertilization to occur, the pollen from the male part ofone plant must be caught bythe sticky stigma within the fiower ofthefemale part ofanother plant. Sugar beets are largely pollinated by wind (Mallory-Smith and Zapiola, 2008, Table 1; OECD, 2001, p. 21). The potential for longer-distance genefiow increaseswith higherwind speeds (Mallory-Smith and Zapiola, 2008, p. 3). Depending on wind conditions, wind-borne sugar beet pollen can be distributed horizontally at least4,500 meters (2.8 miles) (OECD, 2001, p. 22). However, as discussed in Section 3.9, the vast majority ofthe pollen does nottravel these great distances, and the very small amountthat does is unlikely to pollinate another plant. Successful wind-pollinated fiowering plants must produce large amounts ofpollen: the chances ofany single wind-blown pollen grain landing on and being held by the stigma of
Event H7-1 Draft ER 38 Affected Environment 7/28/2010

### another plant are very small. Pollen occurs in "clouds": scientists have estimated sugar beet pollen production at one billion pollen grains per plant (Schneider, 1942, as reported in OECD, 2001, p. 22). There is great competition within this cloud forthe limited available ovules (only one each), and the stray pollen from another source has extremely limited opportunity for success. In a large, densely planted area such as a seed production field, pollination is much more likely from the pollen cloud within the field than from stray pollen from anotherfield (Westgate, 2010, p. 3; Hoffman, 2010a, p. 8)).
While pollen can be maintainedfor longer periods under laboratory conditions, scientists report that sugar beet pollen viability under natural conditions is limited to 24 hours (OECD, 2001, P 22; Hoffman, 2010a, p. 8). 

### 2.5 SUGAR BEET WEED MANAGEMENT This section addresses weed management in sugar beets. Uncultivated wild beets, including feral beets and weed beets, are described in Section 2.9. 2.5.1 

### Weed characteristics and concerns While aweed can be defined as any unwanted plant, problem weeds are those that are competitive and persistent within a given cropping system. Competition for 

### light, water and nutrients. A growertries to capture the plant resources - primarily light, water, and plant essential nutrients; however, competitive weeds often secure some ofthese resources fortheir growth, at the expense ofthe crop. Some common characteristics ofcompetitive weeds are rapid seedling establishment, high growth rates, prolific root systems and large leafareas. Competition for light is probably the most importantweed consideration for sugar beets, particularly in irrigated fields, which promote improved growing conditions. Sugar beets ultimately convert solar energy into sucrose, and reduction in light can have a dramatic impact on yields. Thus, weeds that growtallerthan sugar beets, especially those with broad leaves, compete with available sunlight thatthe sugar beetwould have used to make sucrose. Barnyardgrass (Echinoch/oa crus-gal/i), 

### for example, has broad, flat leaves and can grow up to 5fttall, as can Canada thistle (Cirsium arvense). 

### Common lambsquarter (Chenopodium a/bum) 

### and kochia (Kochia scoparia) 

### are fast-growing weeds that can growto sixft tall and quickly shade sugar beet seedlings. Wild oat (Avena fatua) 

### and green foxtail (Setaria viridis) 

### growto heights ranging from approximately 26 to 41 inches. Sugar beet, by comparison, takes months

Event H7-1 Draft ER 39 

### Affected Environment 7/28/2010

### to reach its final height of approximately 22 inches (Tranel, 2003; McDonald et ai, 2003, pp. 9- 12; Mesbah et ai, 1994, p. 1). 

### Aplant's ability to compete forwater is determined largely by the volume ofsoil the roots occupy. Weeds with large root systems are more likely to be detrimental to sugar beets during periods ofwater stress. Some perennial weeds can store a multi-yearfood supply in their roots (Tranel, 2003; McDonald etai, 2003, pp. -12; Mesbah etai, 1994, p. 1). Plants that develop a root system early in the season have long roots relative to the part ofthe plant above ground and have high uptake potential can compete successfully for nutrients. Simply applying more fertilizer does not solve the problem and may exacerbate it by stimulating weed grow1h; weeds often absorb nutrients faster and in greater amounts than sugar beets (Mesbah et ai, 1994, p. 1). Weed persistence. Persistent weeds are ableto survive year afteryear on a given piece of land, in spite ofa farmer's effortsto control them. Some plants are both competitive and persistent through the production of large numbers ofseeds. The bushy wild proso millet (Panicum miliaceum), 

### for example, shatters upon contactwhen mature, and can produce 400 to 12,000 seeds per squarefoot. While high reproductive rates also contribute to aweed's persistence, dormancy is the most importanttrait in persistence. Cultivated soils typically contain thousands of seeds per square meter, waiting forthe opportunity to germinate. Some weed seeds, for example, velvetleaf (Abuti/on theophrasti), 

### can remain viable in the soil for up to 50 years (McDonald et ai, 2003, p. 12). Many perennial weed species have the ability to reproduce from rootfragments. Canada thistle, for example, has a deep, spreading root system that can continue to send up shoots afterthe surface plant has been removed multiple times. Some weeds have the ability to altertheircharacteristic in response to stress; for example, some weeds respond to drought by flowering and going to seed early (Tranel, 2003; McDonald et ai, 2003, pp. 9-12). 

### 2.5.2 Sugar beets and weeds The sugar beet plant is a poor competitor againstweeds, especially from emergence until the sugar beet leaves shade the ground. Emerging sugar beets are small, lack vigor, and take approximatelytwo months to shade the ground. Thus, weeds have a long period to become established and compete. To avoid yield loss from weed competition, weeds need to be controlled within fourweeks after sugar beet emergence and weed control needs to be

Event H7-1 

### Draft ER 40 

### Affected Environment 7/28/2010

### maintainedthroughoutthe season (Cattanach etai, 1991, p. 6; California Beet Growers Association, 1999, p. 25; McDonald et ai, 2003, p. 13; Mikkelson and Petrof, 1999, p 19). Uncontrolled weeds that emerge with the crop may cause from 30 to 100 percentyield losses (California Beet Growers Association, 1999; p. 25; Sprague, 2009). Increasing weed density causes increasing magnitude ofyield loss, although the relationship is not linear: a fewweeds may not affect yield, and at high weed populations the weeds begin competing with one another. While yield losses are the major concern, weeds create other problems. Late-season weeds can hinder harvesting operations. For example, infestations ofwild mustard can cause loss ofsmall beets during harvesting. Many weed species host pathogens (curly top virus), nematodes (sugar beet cyst nematode) and insects (aphids). High levels ofweed control are essential for profitable sugar beet production (California Beet Growers Association, 1999; p. 25; Mikkelson and Petrof, 1999, p 19; Mesbah etai, 1994). Priorto adoption ofevent H7-1 sugar beets, growers regularly used multiple chemical herbicides to attemptto control weeds. (Cole, 2010a, pp. 12-13; Cole, 2010b, pp. 10-14; Kniss, 2010, p. 5; Wilson, 2010a, p. 9; Hoffman, 2010, p. 12). 2.5.3 Problem weeds in sugar beet production The USDAAgricultural Research Service (ARS) has identified the following weeds as problem weeds in sugar beets that have previously prevented production ofmaximum yields to conventional crops: kochia (Kochia scoparia), 

### pigweed (Amaranthus spp.), 

### common lambsquarter (Chenopodium album), 

### nightshade (Solanum spp.), 

### common mallow (Malva neglecta), 

### cocklebur (Xanthium strumarium), 

### barnyardgrass (Enchinochloa crus-galli), 

### foxtail (Setaria), 

### wild millet (Panicum miliaceum), 

### wild oats (Avena fatua), 

### sowthistle (Sonchus L.), 

### Canada thistle (Cirsium arvense), 

### nutsedge (Cirsium arvense), 

### and dodder (Cuscuta L.) 

### (USDA ARS, 2008, P

### 61). Most ofthese weeds, and others, are presentthroughout all the sugar beet growing regions. Weeds are classified as annual or perennial. An annual is a plantthat completes its life cycle in one year or less and reproduces only by seed. Annuals are further classified as broadleaforgrass. Perennials are plants that live for more than two years. They may reproduce by seeds, rhizomes (underground creeping stems) or other underground parts. Kochia (Kochia scoparia), 

### an annual broadleafplant, is a member ofthe Goosefootfamily, the same family as sugar beet. Weeds in the same family as a crop often thrive in the same growing conditions.

Event H7-1 Draft ER 41 

### Affected Environment 7/28/2010

### Pigweed (Amaranthus spp.) 

### is a broadleafannual that is a weed problem in many crops. There are several species; redroot pigweed is mostcommon (UC Integrated Pest Management [IPM] 2010). Common lambsquarter (Chenopodium album

### )is an annual broadleaf in the samefamily as sugar beets. With its rapid growth and large size it quickly removes soil moisture (McDonald et al,2003). Nightshade (Solanum spp.) 

### is a broadleafannual that grows 6-24 inches tall (McDonald etai, 2003). Common mallow (Malva neglecta) 

### and cocklebur (Xanthium strumarium) 

### are widespread broadleafannuals. 8arnyardgrass (Enchinochloa crus-galli, 

### foxtail (Setaria), 

### wild millet (Panicum miliaceum) 

### and wild oats (Avena fatua) 

### are annual grasses. Sowthistle (Sonchus L.) 

### is a perennial plantthat reaches a height of3to 7 feet and reproduces by seed and underground roots. Canada thistle (Cirsium arvense) 

### is a perennial that reproduces by seeds and underground roots and grows 2 to 5feettall. The roots extend several feet deep and some distance horizontally. Canada thistle is the most prevalent and persistent non-grass weed in Minnesota, and is the no. 1 noxious weed in Colorado. It is a problem weed in all growing regions. (Durgan, 1998, p. 8; Colorado Department ofAgriculture, undated; McDonald etai, 2003, p. 10). Nutsedges (Cyperus spp.) 

### are among the most problematic weeds ofagriculture in temperate to tropical zones worldwide. They are difficultto control, often form dense colonies, and can greatly reduce crop yields. Nutsedges reproduce primarily by rhizomes (UC IPM 2010). Dodder (Cuscuta L.) 

### is an annual parasitic weed that grows only by penetrating tissues ofhost plants to obtain water and nutrients. Each plant produces thousands ofseeds that can remain dormant in the soil foryears

# cue IPM, 20

### 10). Velvetleaf (Abutilon theophrastl) 

### is a broadleafannual that grows 2-7 feet tall (McDonald et ai, p. 12; USDA 1999a, pp. 18-19). Ragweed (Ambrosia spp.) 

### are annual broadleafweeds that can be very 

### competitive with crops.

Event H7-1 Draft ER 

### 42 Affected Environment 7/28/2010

### 2.5.4 Other non-herbicideweed management practices In addition to crop rotation and tillage, discussed above, sugar beet growers ofconventional sugar beets have other non-herbicide meansto manageweeds. Narrow rowwidths (22
- 24 inches) are commonly used by both conventional and sugar beet growers and those growing glyphosate-tolerant sugar beets, for quickercanopy closure (Cattanach etai, 1991; McDonald et ai, 2003; Mikkelson and Petrof, 1999, p. 21). With respect to glyphosate-tolerant sugar beets in particular, because these crops do not require cultivation (i.e., in-crop tillage), sugar beet growers are switching to narrow-row production. With narrower rows, glyphoste-tolerant sugar beets can achieve canopy closure earlier in the growing season, which deprivesweeds of sunlight and therefore retards late season weed growth (Wilson, 201**~b,** 

### p. 4). Growers also use weed-free seed. Additionally, nearly all growers scout theirfields for weeds (Ali, 2004). 

### 2.5.5 Use of herbicidesto control weeds Herbicide use is regulated by EPA under FIFRA, ratherthan by APHIS, and EPA has granted glyphosate reduced risk status (Schneider, 2008, p. 4). Herbicides are used by virtually all sugar beet growers; in 2000 approximately 98 percent of planted acres received one or more herbicide applications (Ali, 2004, Table 4). Herbicides may be used before the crop emerges from the ground (pre-emergence) or after (post-emergence). Pre-plant incorporated (PPI) herbicides are mixed in with the soil before planting. The application method, whether PPI, preemergence or post-emergence, largely determineswhen the herbicide will contact plants and the portion ofthe plant contacted. In selecting a herbicide, a grower must consider, among otherfactors, the potential adverse effects on the crop, whether the herbicide is registered for use on the crop, residual effects that may limit crops that can be grown in rotation, effectiveness on expected weeds, and cost. Herbicide mode ofaction. Herbicides are chemicals that move into a plant and disrupt a vital process. They are classified according to their mode ofaction, which is the overall manner in which the herbicide affects a plant atthetissue orcellular level. Most herbicides bind to, and thereby block the action of, a specific enzyme"6 

### 2.5.6 Weed control with conventional sugar beets Conventional sugar beet growers use the weed control measures discussed above, plus a variety of herbicides. There are hundreds ofcommercial herbicides; only a fraction ofthat total can be appropriate for use with conventional sugar beet (Table 2-3).

26An enzyme is a biological catalyst and is usually a protein. Enzymes are discussed in more detail in Section 3.1.1. 

### Event H7-1 Draft ER 43 Affected Environment 7/28/2010

### The Weed Science Society ofAmerica (WSSA) has classified herbicides by group number, based on their mode ofaction. As shown in Table 2-3, herbicides commonly used with sugar beet include group numbers 1, 2, 3, 4, 5, 8, and 9 (Tranel, 2008, Dexter et ai, 1994; Ross and Childs, undated): Group 1 herbicides inhibitthe action ofthe enzyme ACCase Group 2 herbicides inhibitthe action ofthe enzyme ALS Group 3 herbicides inhibit cell division (mitosis inhibitors) Group 4 herbicides mimicthe plant growth hormone auxin and cause uncontrolled cell growth (synthetic auxins) Group 5 herbicides inhibit photosynthesis Group 8 herbicides inhibit a single key enzyme involved in fatty acid synthesis Group 9 herbicides inhibitthe action ofthe enzyme ESPSP Table 2-4 summarizes the effectiveness ofthe herbicides in Table 2-3 on the important sugar beet weeds identified by USDAARS. As the table shows, no single herbicide is effective on all weeds. Some ofthese herbicides can be mixed together and applied atthe same time (tankmixed). For conventional sugar beets, glyphosate can be applied only pre-emergence. Blank cells indicate no data were available for that source. Current practices forweed control in conventional sugar beets include tillage, pre-plant incorporation ofgrass and broadleaf herbicides, and in-crop use ofgrass and broadleaf herbicide tank mixtures (Dexter and Luecke, 2003; Dexter and Zollinger, 2003; WSSA, 1994). Each ofthese practices has limitations. Cultivation and pre-plant incorporation ofherbicides are associated with narrowwindows ofapplication, which is based on aspecific weed size or crop stage (Baker et aI., 1982; Baker and Johnson, 1979; Campbell and Janzen, 1995; Fawcett, 1995). Additionally, herbicide performance and crop injury are influenced heavily by soil pH, targetweed size, crop size, airtemperature, and irrigation practices. Morever, many ofthe currently applied herbicides leave soil residues, whose persistence can impact crop rotation options in subsequent seasons (Dexter and Zollinger, 2003; WSSA, 1994)

Event H7-1 Draft ER 44 

### Affected Environment 7/28/2010·

## -_.- - 

## _ ...

## _.--_._- - _.- _._----- --- ---- -_ ....- - 

# . -- Agricultural Trade Name WSSA Mode of Acreage Number of

Chemical Treated Applications (Herbicide) (typical) Action Group No. 

### (%) per Year Clethodim Select 1 46 2.5 Clopyralid Stinger 4 74 2.8 Cycloate Ro-Neet 8 5 1.0 Desmedipham Betanex 5 94 2.8 EPTC Eptam 8 6 1.0 Ethofumesate Nortron 8 37 2.1 Glyphosate (Several) 9 13 1.1 Phenmedipham Betamix 5 80 2.6 Pyrazon Pyramin HRAC Group C1 6 1.0 Quizalofop. ethyl Assure II 1 10 1.6 Sethoxydim Poast 1 11 1.7 Trifluralin Treflan HFP 3 5 1.0 Triflusulfuronmethyl Upbeet 2 83 2.7**~** 1 1.565 million acres were planted in the US in 2000. All values are averages. Source: National

Agriculture Statistics Service (www.usda.govlnass); www.weedscience.org; www.hracglobalcom.

Event H7-1 Draft ER 45 Rate per Application (lb/appli.lac) 0.04 0.03 1.84 0.07 2.61 0.06 0.39 0.05 0.82 0.04 0.19 0.65 0.008 Rate per Total Applied Acre perYear tlb/ac) 

### i1.000 Ib)

0.11 

### 77 0.09 102 1.84 139 0.18 270 2.64 230 0.14 82 0.43 86 0.14 170 0.85 76 0.06 9 0.33 56 0.66 55 0.02 29

Affected Environment 7/28/2010

### Table 2-4. Effectiveness of herbicides on majorweeds in sugar beets. Broadleaves

iii" Herbicide 

### z 3 0 ""0 ",. 0 "'0 0

### ~ ",. ::r 

# " en 0 3 0 A in 

## '" .g 3 OJ 3 i5: a 

# " ::r CD 

# " OJ 3 =3 a ::r CD ru 

# '" ""0 a a !)l. iii· CD "- <=**~** :J " :J "- CD**~** en Pre-plantincorporated Ro-Neet
.... .. .

## ..... . ... ... . . ..•...

.. 

### M! Sugar P G F P F



### NDSU P F-G F-G P F-G F-G F-G 

### Uof!D P E G P E P F Pre-emergence Nortron
. . . . . . .

. .. 

### M! Sugar F G G F G



### NDSU F-G G-E F-G 

### P P-F 

### P F-G 

### Uof!D F-G G-E F-G 

### P G-E P F pyramin
. . .... . ... ... . . .

.. .... 

### M! Sugar P G G 

### P E



### UoflD P G-E F-G 

### P G 

### P P Eptam . .

# ...... .. . 

## ....

NDSU F F-G 

## I F-G 

### P F-G F-G 

## I G 

### Uof

### ID 

## I F 

## I F-G 

## I F-P 

## I p 

## I G 

## I P 

## I F-G 

## I E= excellent, G = good, F = fair, P = poor, N = no effect.

Event H7-1 Draft ER 46 Grasses

CD OJ 

### ::; '<

### ~ OJ 

## a. i5: (Q 3**~** OJ en 

### [ en

.... .

# ......... G G G

. . P P G

• ••• .. P P

. .

G-E

G 

## I (f) 0 -n**~** a ::r 1i**~ ~**  CD

G N G-E

G P

F N F-G

G G

.. P 

## I N 

### P P

. 

## I G-E 

## I G 

## I F Perennials Parasite

Z <= in to "- (Q CD

. ..... G F

. P P N P

.. 

## I F 0 OJ :J OJ "- OJ 0 5' 0**~** "- "- CD CD**~**

.. N N P P

N N 

### P P

. . N 

## I P P 

## I N 

## I I p 

## I P

Affected Environment 

### 7/28/2010

### Table 2-4. Effectiveness of herbicides on majorweeds in sugar beets.

Herbicide A 0 C1 ::r oj" 

### Post-emergence Nortron i

........ M/Sugar Pyramin M/Sugar Betamix· M/Sugar NOSU UoflD Betanex

NOSU Upbeet·

.... M/Sugar NOSU Uof/O

Event H7-1 Draft ER 

## -

-

. . ... F F P-F

.. P-F



## - poE

G . Broadleaves



### z cO· 0 lJ 0 ::r cO·**~** C1 

## "' 

## '" 

# " ::r CD CD W 0- CD "- c "- CD**~**

. .... 

### ......... . ..

.. ...................• F G P

..

. F F P

. .

. . G F F G F-G P-F G-E F-G F

. G-E F-G P

......•..... F F F F F N G-E G F Grasses

[JJ 

## or w 3 

### ::; 0-0

### ~ '<

### ~ 0 w "' 0 3 0 

## a. 0: 

## .g 3 w 3 0: 

# '" 3 W 3 =3 0 OJ ;:"0 W 00 

## "' in:**~** ::J " ::J iii" 

# "'

. ... . ..

.. i

.. ...
... .. .. . F P

. 

# .... .. ... . F N

. ... . .

.. .. . 

### ... . ..

.. E P G P N P E P P P-F

. . .. . . G P 

### N P

.. 

# ..... ... .....

. P P P G N 

### N G F P P



### 47 -n 0**~** W



### -

..

.. .. ..... F

.. N

F F F

P

P F-G

P Perennials Parasite

rn 

### z 0**~ ~**  

## "' ::r CD 

### !a "- 

# '" m CD

.. ... ... N N

..............

P N

. .. .. N N

E P

..... -

. .. 

### N N
G P 0 w ::J w "- w 0 5' 0 Ui· "- "- 

## m CD**~**

.

# . ......

. . N

P

... N N P P

### -:

. . N

. . .. P 

### N P P

Affected Environment 7/28/2010

### Table 2-4. Effectiveness of herbicides on majorweeds in sugar beets. Broadleaves Grasses

[JJ ill ID Herbicide 

### z 3 3 <5. 0 tTo

### ~ '<

### ~ "U 0 0 ID <5. :::r 

# " '" 0 3 0 

## a 5: :>; 

## en -g 3 5: "Tl 0 

# '" '" ID 3 <0 0 :::r 

## ro ID 3 3 

# " C1> ID =3 0**~ ~**  :::r tT ;:"0 ID ID C1> "- 00 

## '" m:**~** iii· "- C1>**~** 

### g: :J '" :J 

## en 

## '" Sf' c Inger .....• . ..... .....•

## :

. ...•• ···c_, .. .... . ..- 

# ...................................... ... ............. 

### ....•...........

....... M! Sugar N P F E P NDSU N P F-G E P-F Uaf!D P P F-G E F Progress (a mixture ofBelamixplus Nortron) .

. M! SUQar F G G F E NDSU F-G G G F G-E AssurelllSelect (Assure 1.1 onlyfor.U ofID)

....... .. M! Sugar N N N N N NDSU N N N N N UaflD P P P P P Poast

.. .

.

## ........ .. ..... M! SUQar N N N N N UaflD P P P P P E= excellent, G

# =good, F

# =fair, P

# =poor, N

# =no effect.

Event H7-1 Draft ER N N P N P P P P P P

... •• .. >

.
.. P F

P N P F-G



# ... ......•
.. 

### ..... ... ..... ... G E N E E E P G-E E E

... . .

# ......... E E P G-E E E

48 Perennials Parasite

0 ID :J (jJ Z ID 0 "-**~** c ID 0 

## en :::r 

## s: 0 C1> C;;. "- C;;. "- "-**~** <0 

## ro CD 

## ro g:



# .. . ...••.•...•.> ... 

# . ....... G N G G-E G P E P

.. .... N N N N

... .

### .. ... 

# .. .. ... .. N N N N P P P P

. .... N N N P P


## - P

Affected Environment 7/28/2010

### Table 2-4. Effectiveness of herbicides on majorweeds in sugar beets. Broadleaves Grasses Perennials Parasite

OJ 0 OJ w w Herbicide Z 3 3 ::J <15' 0 0"0

### ~ '<

### ~ (fJ Z W ." 0 0 w 0 C>- <15' ::; 0 <n 0 3 0 

## a c:**~** c: w 0 A 

### en -§3 

### c: -n 

### en 0 :;; 

## "'" w 3 to 0 ::; SO 0 ::; 

### m W 3 3 <1> C>- o <1> W =3 0 iil**~** e;;' C>- e;;' ::; 0" ;0.0 00 W C>- iir <1> C>- c:**~** ::J :;; ::J 

### en <n [ W 

### m to 

### m <1> C>- <1>**~** <n 

### - <1>**~** Glyphosate.

. ...... 

## ·.i>

.......'.' .. 

# ':'

...................... 

## .... .............. .

# ............. .' 

# >....... ."

...... . ... / ." 

### M! Sugar G E G E G E E


## - F G 

### NDSU F-E E P-G E P-E P-G G-E E E G-E Select ". ." .'

..

. •.... '

### .. 

### ........ . 

### .... . ".

. 

# ... ..... ..... 

### Uof!D 

### P P 

### P P P Treflan HFP

. ". 

### .' .. .

# ....... . '.' . 

### ,J!..2tJD F I_G_I 

### P_-' P 1_ F-G 1

E= excellent, G = good, F = fair, P = poor, N = no effect. Blank celis mean no data were available forthat source. P

....... P G-E E E P

.

. . . ' ..... . ' "
. 1 F 1 G 1 1 G 1 P



### Sources: M! Sugar: Michigan Sugar, 2009; 

### NDSU: Slach!erandZollinger, 2009; 

### Uof10: MOIishila, 2009

Event H7-1 Draft ER 49 

### P

' .

1 

### P P P

.. .'
.
1 P 1 P

Affected Environment 7/28/2010Conventional weed control options are complex duetothe need for several applications of multipletank-mixed herbicidesto achieve long-term, broad-spectrum weed control. As an example, a common practice in sugar beet production is to use "micro-rates" of herbicides (Dexter and Zollinger, 2003). This is accomplished by tank mixing multiple herbicides at reduced rates in combination with an oil additive. The components ofthe tank mixture may include Betanex (desmedipham), Betamix (phenmedipham + desmedipham), Nortron (ethofumesate), Upbeet (triflusulfuron methyl), and Stinger (clopyralid); and Select (chlethodim), ifgrasses are present. A minimum ofthree applications is recommended, beginning atthe cotyledon growth stage and followed by weekly applications ofthis herbicide mixture. The intent ofthe micro-rate program is to loweroverall herbicide costs and reduce the potential for crop injury. A member ofthe Minn-Dak Farmers Cooperative, who farms about 1,100 acres of sugar beets annually, described his conventional weed control system (Mauch, 2010, pp. 2-3):
Priorto planting Roundup Ready®sugar beet, my herbicide regimen for conventional beet seed was very complicated and labor intensive. Pre-emergence, I used acombination of Eptam (which is very toxic to the sugar beet) and RoNeet (which is very expensive). Approximatelytwo weeks afterthe beet plants emerge, Istarted spraying a mix of BetaMix, Betanex, UpBeet, Nortron and Stingerand adjunctives to make the herbicides stick betterto the crops. This would be sprayed fourtimes (approximately once aweek). Even afterspraying several times, there were still weeds and Ithen needed to hire manual laborto hoe and pull out the weeds.

This description ofthe complexity ofconventional weed control is similarto that provided by researchers evaluating weed management in sugar beets (Odero et ai, 2008). Odero et al evaluated 20 differentweed treatment alternatives for conventional sugar beets and found that the following treatmentyielded the highest net economic return: PPI treatmentwith Nortron (ethofumesate), followed by three micro-rate treatments ofa tank mixture of Betamix (phenmedipham + desmedipham) and Nortron (ethofumesate), followed by Outlook (dimethenamid-P); with hand-hoeing following each herbicide application. Other researchers have also found that a combination of herbicides plus hand hoeing is required to effectively control weeds in conventional sugar beets (Dexterand Luecke, 2003). Hand-weeding is necessary in many situations; however, it is cost-prohibitive as a replacement for herbicides. USDA data shows that in 2000, conventional sugar beet growers spent an

Event H7-1 Draft ER 

### 50 Affected Environment 7/28/2010

### average of$94.28/acre for all chemicals (insecticides, herbicides, fungicides, etc.) (Ali, 2004, p. 7). Five-year studies ofthe cost ofhand-weeding sugar beetat the University of California
- Davis, as reported by the California Beet Growers Association, found thatthe cost ofhand weeding was between $260to over $650 per acre (California Beet Growers Association, 1999, p. 29). Using the midyearof 1996 as the base year, this is equivalentto approximately $373 to $914 per acre in 2010 dollars, orapproximatelythree to seven times what sugar beet growers spent on all chemicals. More recently, scientists in Wyoming have found that net returns for optimal herbicide application combined with hand weeding are more than twicethe net returns for hand weeding alone (Odero et ai, 2008, Table 4). 2.5.7 Weed control with event H7-1 

### In-crop applications ofglyphosate can be madefrom crop emergence up to 30 days prior to harvest. This flexibility allows the growerawiderwindow ofapplication, with the application timing based on weed pressure, not on crop stage. Typically only 2-3 post-emergence applications ofglyphosate are applied with GE sugar beets (Mauch, 2010; Grant, 2010). The broad spectrum ofweed control offered by glyphosate (Table 2-4) reduces the need fortank mixing with additional herbicides. However, the use ofother herbicides in combination with or in sequence with glyphosate is recommended as needed under specific conditions to address selectweed and/orweed resistance issues. Monsanto's Technology Use Guide (TUG, 2010, Appendix E) provides specificweed control recommendations for event H7-1 sugar beet. The TUG recommends the use of"mechanical weed control/cultivation and/or residual herbicides" with event H7-1 sugar beets, where appropriate, and "additional herbicide modes ofaction/residual herbicides and/or mechanical weed control in other Roundup Ready® crops" rotated with event H7-1 (TUG, 2010, p. 40).


### 2.6 HERBICIDE RESISTANCE Herbicide resistance is "the inherited ability ofa plant to survive and reproducefollowing exposure to a dose ofherbicide normally lethal to the wild type" (WSSA, 1998). Herbicide resistance is a result ofnatural selection. Plants ofa given species are not all identical; they are made up of"biotypes" with various genetictraits. Biotypes possess certain traits orcharacteristics notcommon to the entire population. Herbicides, that suppress or kill weeds, can exert selection pressure on weed populations. When a herbicide is applied, the plants with resistance to it, which had no special survival qualities before the herbicide was
Event H7-1 Draft ER 51 Affected Environment 7/28/2010introduced, become the survivors who are then ableto reproduce and pass on theirgenes. With repeated application ofthe same herbicide and no other herbicide orweed control practice, the resistant biotype becomesthe dominant biotype in thatweed community. In the mid-1950s, Harper (1957) theorized that annual, repeated use ofany herbicide could lead to shifts in weed species composition within a crop-weed community. Similarly, Sandeen etal. (1982) suggested that a normal variability in response to herbicides exists among plant species and tolerance can increase with repeated use ofan herbicide. Indeed, as ofJune27,2010, 341 herbicide resistantweed biotypes have been reported to be resistant to 19 different herbicide modes of action (Heap, 2010). Glyphosate-resistantweeds accountfor 5 percent ofthe herbicide resistant biotypes while weeds resistantto herbicides that inhibit acetolactate synthase (ALS), such as Upbeet, accountfor31 percent ofthe herbicide resistant biotypes. (Wilson, 2010a, p. 6). Figure 2-3 showsthe increase in herbicide resistant biotypes with time. Among the herbicides commonly used in conventional sugar beet, Assure II, Poast, and Select are ACCase inhibitors; Upbeet is an ALS inhibitor; Trefian HFP is a dinitroaniline; Stinger is a synthetic auxin, and glyphosate is a glycine. Figure 2-3 shows only the numberofconfirmed resistant biotypes. The total extentand distribution ofresistant biotypevaries widely. Details ofherbicide resistant weed in sugar beets are discussed in Section 3.12. Foras long as herbicide resistance has been a known phenomenon, public sectorweed scientist, private sectorweed scientist and growers have been identifying methodsto address the problem. For instance, when a farmer uses multipleweed control tools to achieve weed control, herbicide resistance biotypes will be controlled and the resistance biotype generallywill not becomethe dominant biotype within a population (Gunsolus, 2002; Cole, 201Oa, p. 4). Sy contrast, weed resistance is known to occur most rapidly in areas wherethere is a sole reliance on a single herbicide used repeatedly over multiple crop generationsforthe management ofa specific weed spectrum. When a growerencounters a biotypethat is resistant to an herbicide he is using, the grower must use an alternate method ofweed control. Management practices that can be used to retard the development ofresistance, such as those routinely used by sugar beet growers, include herbicide mixtures, herbicide rotation, crop rotation, and increased cultivation.

Event H7-1 Draft ER 52 Affected Environment 7/28/2010120

-m-ACCaseInhibitors 100 ---k-ALS Inhibitors

- Dinitroa.'1iiines**~** -±-Triazines 0- i?- 80 --Q-Ureas, Amides**~.** 0 -+-Bypyridiliums 

## i!i**~** -**~** -+-SyntheticAUirim 

### - , 

### ::: 60**~Glycines** 

### E**~ .~**  

## .-**~** 40 '- 0**~** 

# "" <=

# ~**~O o~~** 

### ..**~~~~~~** 1950 1955 1960 1965 1970 1975 1980 1985 1990 1995 2000 2005 1010 

### Year Source:IallHeap h

Up:/V{ eeclScience.com 

### Figure 2-3. Herbicide resistance worldwide Management practices that can be used to retard the development of resistance. such as those routinely used by sugar beet growers, include herbicide mixtures, herbicide rotation, crop rotation, and cultivation_ The WSSA reports: "Weed scientists knowthat the best defense against weed resistance is to proactively use a combination ofagronomic practices, including thejudicious use ofherbicides with alternative modes ofaction either concurrently or sequentially" (WSSA, 2010b)_
2.7 

### SUGAR BEET SEED PRODUCTION 2.7.1 Variety development When developing plantvarieties for commercial release, plant breeders select individual plants with desirable characteristics, such as higheryields or pathogen resistance_ This breeding involves transferring pollen from one source plant to fertilize another plant Once plants with the desired traits have been selected, a population ofthose plantswith similar characteristics are classified as varieties_ Commercial sugar beetvariety development has been done exclusively by private sugar and seed companies in the US. Currently these are CrystallACH, Hilleshog (Syngenta), Seedex,

Event H7-1 Draft ER 53 

### Affected Environment 7/28/2010Betaseed (KWS) and SESVanderhavefHolly. As plant breeders continue to develop new germplasm, the identification ofdesirabletraits (e.g., resistance to specific diseases, high sugar content, etc.) is incorporated into the development of newvarieties. Dueto geographic variability in weather, growing conditions, climate, insectand diseasesusceptibilityvary from region to region, differentvarieties are developed fordifferent regions. Sugar beet company selection committees in each region establish a list ofapproved varieties based on coded variety trials, which are designed to give an unbiased evaluation ofthe genetic potential ofall sugar beetvariety entries while othervariables (stand, fertility, moisture levels, etc.) are kept constant. Growers may grow onlythosevarieties that appear on the sugar beet company approved listforthat region. Variety trials insure the use ofthe most productivevarieties to maximize returns to the growers and sugarcompanies. Trials last2 to 3 years and involve millions ofplants each year. 2.7.2 Hybrids and cytoplasmic male sterility To produce seed for commercial planting ofthe chosen variety, some crops, such as cotton and soybeans, rely on the same individual plantto serve as thefemale (pollen acceptor) and male (pollen donor) to produce seed. Othercrops, such as corn and sugar beet, rely on two different varieties, called inbreds, to produce hybrid seed that carries traits from both parent lines. Hybrid varieties typically exhibit greatervigorthan the parent lines on which they are based, resulting in plants with higheryields, better resistance to stress, and other desirabletraits. Once a biotech plant such as event H7-1 has been developed, researchers will usethat plantto breed the biotech trait to othervarieties. In breeding sugar beetvarieties forfuture commercial production, the biotech trait could be maintained on eitherthe male orfemale plants. For greater breeding flexibility and efficiency in producing newvarieties, plant breeders may prefer to breed additional varieties by introducing the biotech trait on male pollinator population of plants and use those plants to fertilize the same male-sterilefemale plants (Skaracis and De Biaggi, 2005). Ifthe biotech trait is only on thefemale (male sterile) plantwith eMS, as discussed below, thattrait cannot be transferred to other plants in orderto breed new inbreds. In hybrid sugar beet seed production, although each plantflower contains both male (the anther) and female (the stigma) parts, individual plants can be madefemale-only, or male sterile. Male sterility results in thefailure of plants to producefunctional anther, pollen or male gametes (Hovland, 2010, p. 2). In orderfor seed multiplication ofthe male sterile orfemale plantto occur, plant breeders develop a partner line ("0-Type") which is genetically identical to its equivalent male sterile orfemale linewith the exception ofits abilityto produce pollen. This Event H7-1 Draft ER 54 Affected Environment 7/28/2010

### identical O-Type is then used as the pollinator (male plant) to pollinate the female plant, resulting in offspring that will again be male sterile and not produce pollen. This seed, after meeting quality criteria relative to any impurities, is then used as the male sterile orfemale basic seed in the commercial seed production fields. This system is known as Cytoplasmic Male Sterility (CMS). It is the system used in many other crops to develop male sterile orfemale basic seed lines that do not produce pollen. Using female-only plants in seed production ensures thatthe hybrid seed harvested from those plants will be a cross between the two parent lines. Male and female lines are planted in alternating strips in a sugar beet seed production field, typicallywith two to fourtimes as many female rows as male rows to maximize the amount ofseed collected (Hoffman, 2010a, p.5). Often stecklings (small transplants) are used forthe male lines. After pollination occurs, the male plants are destroyed (Holly Hybrids, 2007). Only

CorvaUis

### ~

### ~

Eugene, 01**~ ~**  p WODdburn .:; /'**~** 

# J :!. ./ Salem 

### * Of"""".'":,,,

.. 1.'''''''' Oregon City

s"J!/i"'''lrj,·,·r 

## ,

., .'{:

"'-:.",



## , ;',

., ':: 

### o**C;""P'''~~"** /("""



### Figure 2-4. Willamette Valley Source: Givlerand Wel/s, 2001 

### very rarely would a CMS fertile plant produce pollen and such plants can be identified and rogued.

One producer reports identifying only two pollenproducing plants within a crop ofover eleven million total plants (Anfinrud deposition, 2010,178). In the Willamette Valley, 78.6% ofthe 2009-2010 seed crop were grown with the glyphosate-toleranttrait on the female inbred. These female inbreds are male sterile because ofthe CMS trait and thus are bred not to produce pollen. (Preliminary Injunction Hearing, March 5, 2010, pgs. 17-18; 25). Therefore, the risk of transferring the glyphosate-toleranttraitto other plants from these seed production fields is negligible orzero.

2.7.3 Commercial sugar beetseed 

### production 

## Willamette Valley At least ninety-five percent ofthe Oregon sugar beet seed production (equal to 70% or more ofthe total US

55 Affected Environment 

### 7/28/2010production), is in the Willamette Valley, located between the Coast Range and the Cascade Range (Figure 2-4 at left) (Stankiewicz Gabel, 2010, p. 7). The valley is over 100 miles long. The climate is cool enough forwintervernalization (prolonged exposure to a minimum cool temperature for a prolonged period oftime that enables the plantto flower) butwarm enough for the roots to live through the winter. Summers arevery dry, producing ideal conditions for seed harvesting. While sugar beet is normally a biennial plant, conditions in the valley are such that seed can be produced in one year ratherthan two. Sugar beet seeds are planted in August or September and vernalize overthe winter. The following spring, the plant produces a seed stalk (bolt). Seeds are harvested in lateJulyto August. One seed company, Betaseed, growsthe basic and commercial seed for its varieties atthe southern and southeasternfringes ofthe Willamette Valley

.. Syngenta develops its varieties elsewhere, and then ships the basic seed to West Coast Beet Seed Company (WCBS) forthe commercial production. SESVanderHave develops its varieties both in the Willamette Valley and elsewhere, and ships basic seed produced elsewhereto West Coast Beet Seed Company (WCBS) forseed production. WCBS isjointly owned by a group ofsugar beet seed and sugar companies. With its unique growing conditions, the Willamette Valley is used for seed production for many different kinds ofseeds. In addition to seeds, manyvegetables are also grown in the valley. It is a majorarea for production of"most temperate vegetables, herbs and vegetable seeds" (Mansour, 1999). Because high quality and seed purity are importantto many growers, and because the valley is the site ofvaried seed production, sugar beet seed production companies have worked cooperatively to develop and implement protocols to maintain seed purity and quality. Most seed companies, including both WCBS and Betaseed, belong to the Willamette Valley Specialty Seed Association (WVSSA) and follow the guidelines for isolation and minimum separation distances between fields (Appendix A). WCBS and Betaseed have developed explicit standard operating procedures and grower guidelines that are intended to minimize and/or eliminatethe possibility of inadvertentseed mixing (Appendix B). 

## Maintainillgthe illtegrityof seeds Currently, the WVSSA implements pinning procedures and isolation guidelinesfor seed production within the Willamette Valley. Pinning procedures identifythe geographic location of production fields by placing pins and flags on a map. This is used to establish isolation distances between seed production fields. Additionally, WCBS and Betaseed have instituted
Event H7-1 Draft ER 

### 56 Affected Environment 7/28/2010

### protocols and management practices to further maintainthe integrity ofseed which are essentially the same as required by Item 4 ofthe interim measures (Section 1.1.3). Seed production and quality control are a significant cost, to seed companies, and these companies within the Willamette Valley and throughout seed production areas carefully control growing conditions and production practices to ensure that seed is pure and ofhigh quality
- despite the fact that quality control in seed production carries significant cost. 

## weBS Seed Production. WeBS currently produces much ofthe sugar beet seed for some of the sugar beet seed companies

.. WeBS obtains basic seed from these sugar beet companies to further increase these small seed volumes into larger commercial quantities. Management of these fields and planting locations is controlled utilizing a tracking and tracing system distinguishing seed lots from the moment of initial delivery ofseed, designated for seed production, to WeBS throughout the subsequent planting and harvest. This management further continues until the delivery ofthe finished packaged seed to the customer. Some companies further incorporate various computerized and digital tracking systems designed to manage real-time seed batch movement and qualitytesting. Many ofthese companies have sealed packaging and specified color coding designationsto further identify seed batches/lots. (Meier, 2010, p. 3). Similarly, other companies ship event H7-1 sugar beet seed in packages accompanied by a declarations documentthat states the event H7-1 status ofthe basic seed (Anfinrud, 2010, p. 2). weBS contracts to individual growersforseed production. WeBS prohibits production ofa red beet or Swiss chard seed crop by any WeBS grower in ayear in which that grower is producing sugar beet seed, whethergenetically engineered (GE) 

### or conventional. WeBS also prohibits the sharing ofplanting, cultivation and harvesting equipment for red beet/Swiss chard and sugar beet seed, whetherthey are producing GE or conventional sugar beet seed (Loberg, 2010, p. 2; also in Appendix Bofthis ER27). 

### In addition, WeBS requires its growers, by contract, to adhere to minimum isolation distance within a three mile radius ofany GTfield (Appendix B). weBS maintains control ofall material, whether GE orconventional, from point oforigin to return ofthe seed to the seed company (Appendix B). This includes control ofthe disposal of any excess GE stecklings that are not used for seed production. When those stecklings are not used for seed production and remain in the nurseryfield, such stecklings are uprooted and

27 These requirements are in the Appendix B WeBS protocol, underthe heading "GM Grower Guidelines." While the title is "guidelines," the protocol is clear that these restrictions are included in WeBS contracts with growers. Event H7-1 

### Draft ER 57 Affected Environment 7/28/2010

### mixed into the soil during tillage for soil preparation forthe next crop. Destruction occurs with this tillage and is followed by chemical control in the subsequent crop. Stecklings that are removed from the nursery, but are not used, are destroyed or securely disposed. The prevailing method is returning unused stecklings to the nurseryfield oforigin and subsequent destruction through standard agricultural practices (physical destruction with tillage and chemical destruction in the subsequent crop) (Loberg, 2010, p 2; and Appendix B ofthis ER). Precleaning ofseed atWeBS for shipmentto the seed development company takes place in the dedicated WeBS facility. This process removes sticks, chaff, weeds and the like that may be contained in the seed when initially harvested. Because WeBS does not handle red beet or Swiss chard seed, its seed precleaning operations present no opportunityfor mechanical mixing ofsugar beet seed, whether conventional or GE, with red beet or Swiss chard seed. In years when WeBS produces both GE and conventional sugar beet seed, physical separation requirements and cleaning protocols protect against inadvertent mixing. In 2009, only two growers produced conventional seed for WeBS. All ofthis conventional seed was pre-cleaned at the end ofthe season, aftercompletion ofthe pre-cleaning ofthe event H7-1 seed and after complete cleaning ofthe equipment. After the pre-cleaning, WeBS returns the seeds to the seed development company in sealed containers with color-coded labeling and shipping documents, which are checked upon arrival at seed processing facilities. Syngenta, for example, marks each containerwith a computergenerated and tracked batch number (Meier, 2010). SESVanderHave labels its event H7-1 seed with an orange triangle. (Anfinrud, 2010, at p. 3). Betaseed seed production. Betaseed performs its own basic seed production, and like WeBS, it contracts commercial seed production to individual growers. Betaseed has adopted standard operating procedures (SOPs) that require all materials to be adequately identified and tracked through a computerized, bar-coded system from basic seed production to commercial seed production to final processing and shipping. All Betaseed personnel involved in seed production are trained in the SOPs and required to sign an acknowledgementthat they have read, understood, and will comply with the SOPs (Lehner, 2010, p. 10). Betaseed supervises its commercial seed growers' practices for conformance with Betaseed's stewardship requirements. Betaseed's grower contracts provide forsuch supervision, as well as Betaseed's right to enterthe grower's fields and take remedial action ifthe grower does not

Event H7-1 Draft ER 58 

### Affected Environment 7/28/2010

### comply with Betaseed's instructions. Betaseed pins all ofits commercial seed fields in compliance with the WVSSA's pinning rules to ensure that isolation distance guidelines are followed. In addition, Betaseed requires its growers, by contract, to adhere to isolation distances offour miles from other crops that may cross-pollinate with sugar beets

.. Betaseed also requires growersto clean their equipment before and after harvesting a sugar beet variety, and to monitorfor and eliminatevolunteersugar beets. According to the SOPs, Betaseed personnel are presentforthe beginning of every harvest by a commercial grower. Betaseed provides bar-coded tote boxes into which the harvested seed is placed for transportto Betaseed's processing facility (Lehner, 2010, pp. 3-5). Betaseed performs "grow-outs" each year in which it plants samples ofits commercial seed lots to ensurethatthe seed produces the expected variety ofplant. Betaseed's grow-out observation plot did not produce any off-types this year (Lehner, 2010, p. 3). Syngentaseed processing. Syngenta processes sugar beet seed in its facility in Longmont, Colorado that is used only for sugar beet processing; asmall percentage ofthe seed is processed bythird party seed vendors in separate facilities dedicated to sugar beet processing (facilities where no red beets or Swiss chard seeds are processed). Processing ofseed requires seven months and involves polishing, sorting by size, pelleting, treatmentwith fungicides and insecticides required by certain customers, coloring, packaging and shipping to growers in sealed packages. Syngenta maintains an extensivetracking and tracing system for every seed lot. This system includes avisual color identification ofall RRSB material; a computerized, real-time record ofseed batch movement, periodic germination and genetic identitytesting; and extensive employee training. Syngenta also uses cleaning protocols to prevent any inadvertent mixing of RRSB and conventional sugar beet seed during processing. The cleaning process requires the removal ofall RRSB seeds from the equipment and the plant floor. "Chase" seed is used to ensurethat all GT seed has been removed from the equipment (Meier, 2010). with color-coded labels (Meier, 2010). SESVanderHave seed processing, storage, treating, packaging, warehousing, transportation and distribution. Neither SESVanderHave, its growers nor its contractors are involved in any respect in chard or red beet breeding, production or processing. SESVanderHave's GE protocols require that conventional seed and event H7

### -1 seed are never handled or processed atthe sametime. For example, SESVanderHave does not allow its

Event 

### H7-1 Draft ER 59 Affected Environment 7/28/2010processing contractors to process conventional seed atthe same time thatthey are processing event H7-1 seed. (Anfinrud, 2010, p. 3). SESVanderHave receiving/storage of unprocessed seed protocols. SESVanderHave has additional GE protocolsthat apply to unprocessed seed shipped from West Coast Beet Seed. All event H7-1 seed products are identified upon arrival at bulk storagefacilities. Shipping documentsfrom West Coast Beet Seed are used to double checkthe seeds that arrive in Sheridan, Wyoming facilities. Also, properdisposal ofreject or spilled seed is established by variety, lot and size. Product is unloaded only after insuring that storage bins and label bins have appropriate markings (event H7-1 products are labeled with an orange triangle). (Anfinrud, 2010, p. 3).
SESVanderHave seed processing/storage protocols. Seed processed on behalfof SESVanderHave by third parties are subject to contractual arrangements that require compliance by processing contractors with SESVanderHave's GE protocols designed to prevent mixing ofevent H7-1 seed with other seeds during thevarious processing, treating, packaging, warehousing, transportation and distribution stages. Before dumping seed into the seed processing line, necessary equipment (conveyors, legs, distributors, storage bins) is cleaned. Product is unloaded only after insuring that storage bins have appropriate markings (event H7-1 products are labeled with an orange triangle). A key lock and appropriate label is placed on each bin discharge slide. Once product is in storage bins, the tops of bins are sealed by tinning pipe. Ifnecessary, unloading equipment is cleaned and seed is disposed ofin proper manner followed by a documented inspection. Bins with event H7-1 products are labeled with an orange triangle. Processed seed is placed into properly labeled storagetotes and clean-down procedures are followed between seed lots. Rejected seed is disposed in a local landfill. All event H7-1 seed totes are labeled with an orange triangle. Totes are then transferred to the warehouse and put in inventory by variety, lot number, warehouse and slot. (Anfinrud, 2010, p. 

### 3). SESVanderHavetreating and packaging protocols. Productto be primed, pelleted, treated and packaged is identified. When event H7-1 seed enters any facility undercontractwith SESVanderHave, the necessary equipment (legs, distributors, blending system, Delta screen, treater, conveyors, aspirators, and bagging scale) is thoroughly cleaned beforethe productis introduced. All processes require documentation ofweights introduced and weights after contract processing is complete. All contractors have been audited by SESVanderHave

Event H7-1 Draft ER 60 Affected Environment 7/28/2010personnel to assure compliance with GE protocols. Final packaging ofevent H7-1 seed is done in approved packages with proper labels. Packaged seed is transferred to the warehouse and put on inventory byvariety, lot, treatment, warehouse, and slot. When treating ofevent H7-1 seed is completed, ifnecessary, all treatinglpackaging equipment is cleaned following cleandown procedures. Reject seed is disposed ofin an appropriate manner. (Anfinrud, 2010, p. 4). SESVanderHave warehOUSing, transportation and distribution protocols. Seed to be shipped is identified by printing delivery ordersthat identify event H7-1 seed. Warehouse crews stage loads. Each pallet ofevent H7 -1 seed is identified with a cover sheet. Any broken bags during transportation are recovered and returned to the originatorfor proper repair or disposal. Drivers are informed that event H7-1 seed is present on loads. Sales and marketing personnel confirm that event H7-1 seed shipments areto approved customer locations (Anfinrud, 2010, p. 4). SESVanderHaveAuditing ofCompliance with GE Protocols. SESVanderHave audits its contractors' compliancewith its GE protocols as well as its own complianceto assurethat SESVanderHave's standards ofstewardship are maintained. SESVanderHave employees as well as outside consultants haveworked on the audits, which have covered production, storage, processing, priming, pelleting, coating, packaging, handling, shipping and distribution ofevent H7-1 sugar beet seed. (Anfinrud, 2010, p. 4). Betaseed seed proceSSing. Betaseed processes and packages its own seed fordistribution. Betaseed does not produce or process seed ofany Beta species otherthan sugar beets, so there is no potential for mixing ofGE seed with seed ofany other Beta species in Betaseed's processing facility (Peters, 2010, p. 2). Betaseed employs a computerized tracking system to ensurethat all of its varieties ofseed are kept separate as they are processed. All processing steps are recorded and auditable. Every box ofseed that is processed is accompanied by both a human readable label and a bar-code containing information aboutthe seed, including whether it is GE orconventional. Seed cannot be loaded into Betaseed's processing equipment until the bar-code accompanying the seed has been scanned and the seed is determined to be ofthe intended variety. In the lasttwo seasons, Betaseed has only processed onevariety ofconventional seed (and only a single lot ofthis variety in the last season). To avoid the possibility ofany mixing ofGE seed with the conventional variety, Betaseed processed its conventional seed before processing any of its GE seed. Betaseed thoroughly cleans its entire processing system before and after processing conventional seed (Peters, 2010, pp. 2-4). Event H7-1 Draft ER 61 Affected Environment 7/28/2010

### Betaseed also conducts bioassaytests on each lot ofseed at leasttwice as the seed is processed through its plant to ensure that lots ofGM varieties are glyphosate resistant and that conventional varieties do not contain GM seeds (Peters, 2010, p. 4). 

### 2.8 RED TABLE BEET, SWISS CHARD, AND SPINACH BEET PRODUCTION 2.8.1 Vegetable beet production In the USDA database, "beets" include red table beets, Swiss chard, and spinach beets (grown forthe leaves). In the following discussion, these products are referred to as "vegetable beets." In 2007, the most recent yearforwhich published data are available, 8,412 acres ofbeets were harvested in the US, on 2,744 farms, for an average ofthree acres perfarm. Approximately 63 percent ofthe acreage was for processed beets, and the restforthe fresh market (USDA NASS, 2010b). The total value ofvegetable beet production in 1999, the most recentyearfor which USDA has data available, was approximately $7 million. Based on the most recent year forwhich USDA has both harvested acreage and production value data (1997), the average value ofvegetable beet production per acre was approximately $720, which would be roughly $1,000 in 2010, adjusted for inflation (USDA NASS, 2010b). There is little overlap between areas of majorvegetable beet production and sugar beet root production. Over halfthe 2007 acreage ofvegetable beets (59 percent) was in two states, New York and Wisconsin, where sugar beets are not grown. California harvested 979 acres of vegetable beets in 2007. All California counties with five or more harvested acres reported are coastal. 28 

### Sugar beets are grown only Imperial County in California. Oregon harvested 425 acres ofvegetable beets, but no vegetable beet production was reported in the two Oregon counties with sugar beet root crops; however, some vegetable beet crops are grown in the Willamette Valley. One county in Colorado (Larimer), and one county in Michigan (Lapeer), reported both sugar beet and vegetable beet harvests. No more than 7 acres ofvegetable beets were harvested in any single Minnesota county. Harvested vegetable beet acreage for all other sugar beet producing states in 2007 was ten acres or less each (Montana, Idaho, Nebraska, North Dakota, and Wyoming) (USDA NASS, 2010b). Although there is little overlap in major production areas, based on USDA FSA (Farm Service Agency) data, vegetable beet crops and sugar beet crops can sometimes be found growing in adjacent fields (Stankiewicz Gabel, 2010, p. 8).

28 These results, which don't distinguish between organic and conventional, are not completely consistent with the State of California organic results discussed in Section 2.4.3, probably because of variations in the database of growers reporting. 

### Event H7-1 Draft ER 

### 62 Affected Environment 7/28/20102.8.2 Red table beetand Swiss chard seed production The most comprehensive data currently available for red table beet and Swiss chard seed production is from the FSA, however, the FSA does not distinguish between organic and conventional. Also, FSA does not include leafbeetseed production, which is apparently minor. According to data from the USDA FSA, red table beet seed in 2009was grown on approximately 1,130 acres, with 92% grown in Washington State, 7% in Oregon and 1 % in California; and Swiss chard seed in 2009was grown on approXimately 166 acres, with 51% grown in Washington State and 49% in California. Based on FSA data, there are no counties where both Swiss chard and table beet seed are grown, and only one county, in the Willamette Valley, where both sugar beet seed and table beet seed are grown, In that county the FSA data lists onlytwo table beet seed fields, Thetotal FSA-reported red table beet seed production in Oregon is approximately 79 acres (Stankiewicz Gabel, 2010, p, 7), There is also minor Swiss chard seed production in Oregon, Based on older USDA published data, ninety-five percent ofUS red table beet seed production (650 to 700 acres) occurs within the small-seeded vegetable seed production area ofwestern Washington State that includes Skagit, Island and Snohomish counties (See Figure 2-1 for locations) (Foss, 2007), These data do notexactly match the FSA data becausethey are for differentyears, and planting practices change from yearto year. Neithersugar beet root crops norsugar beetseed crops are grown in the part ofwestern Washington where the majority ofthe US red table beet and Swiss chard seed production occurs, Very little sugar beet root crop is produced in Washington State; the nearest processing facility is fartothe south, in southern Idaho, In 2008, only one county, Benton reported sugar beet production (1,600 acres) (USDA NASS, 201Ob), Benton County is in the Columbia Basin on the east side ofthe Cascade Range, There is no reported production of Beta seeds other than minorsugar beet in the Columbia Basin, Duethe extreme distance ofthis sugar beet production area from the Idaho processing facility, it is very unlikelythat anyonewould consider growing west ofthe Cascade range, in the area of other Beta production, As setforth in Section 2,3,2, transportation costs and proximityto a processing facility are key limiting factors in whereto growsugar beets. The locations of red table beet and Swiss chard seed production in California are not known, but sugar beet root crops are grown only in the Imperial Valley, and these are conventional sugar beets,

Event H7-1 Draft ER 63 Affected Environment 7/28/2010

### As discussed in Section 2.7.3, the majority ofthe US sugar beet seed production occurs in the Willamette Valley where seed production for the various beet products (sugar beet, table beet and chard) is divided along geographical lines. Sugar beet seed is grown in the southern and central portions ofthe valley, table beet seed is grown in the northern region, and Swiss chard seed is grown at the margins. 29 

### Thetotal estimated red table beet and Swiss chard seed production in the Willamette Valley in 2010 is 100 to 120 acres (McReynolds, 2010). Based on the FSA data, this appears to be all orvirtually all ofred table beet and Swiss chard seed production in Oregon. Commercial seed production for red table beet is similarto thatfor sugar beet. Seed companies retain ownership ofthe seed, the growing crop, and the harvested seed. Growers produce and harvestthe crop, and are then paid the contract price ifthe resulting seed meets contract quality criteria, typically an 85 percent seed germination rate and 99 percent purity (Foss, 2007). Typically, the red table beet crop is planted in seed beds in mid-June. Plants not displaying true varietal characteristics are removed by hand. In October, the beets are topped mechanically, dug, placed in windrows, and covered with about one foot ofsoil to protect the roots against freezing during the winter. In March orearly April, the over-wintered roots (stecklings), are removed from the windrows and broughtto Skagit County fortransplanting into production fields. Exposure ofthe roots to the winter season in windrows, followed by transplanting into fields in the spring, vernalizes the stecklings. Seed harvest occurs in late summer and early fall (August to September). The crop is cut, placed in windrows, dried 10 to 14 days in the field, and then threshed mechanically to capture the seed (Foss, 2007). No information for Swiss chard seed production practices was found.

29 

### Morton, 2010, 

### p. 149:24-150:20. Event H7-1 Draft 

### ER 64 

### Affected Environment 7/28/2010

### 2.8.3 Organic Red Table Beetand Swiss Chard Production California is the only state forwhich organic red table beet and Swiss chard production data are publicly available. In USDA's reports, red table beets and Swiss chard are included in the "other vegetable" organic category. California accounts for76 percent of"other" organic vegetable production within the sugar-beet producing states, and there is very little or no organic production of red table beets, Swiss chard, or leafbeets in the four rnajor sugar beet production states (MN, NO, MI and 10) 

### (Figure 2-5) (USDA, 2010c). The 2007 acreage and dollarvalue of organic red table beets and Swiss chard in California are shown in Figures 2-6 through 2-9. No data were found for organic seed production of red table beets, Swiss chard or spinach beets.

" CA rnWA 

### [TIeo mOR " MI ttlMN " ID " MT

WY



### Figure

### 2-5. Distribution of "other" organic vegetable production across sugar beet producing states, 

### 2008 Source: USDA.2010c

Event H7-1 

### Draft ER 65 Affected Environment 7/28/2010Legend 

# o Lesslhan 1 

# o 1to 10**~** 1010100 

### NEV/\Ot\

Tu!.!c



### Figure 2-6. California acreage oforganic beets (non-sugar), 2007 Source: Califomia DepartmentofFoodandAgriculture, 2010

Event H7-1 Draft ER 

### 66 Affected Environment 7/28/2010Legend 

## D Lessthan $1,000 

## D $1,000to $10,000 $10,000 10 S100,000 

## ill $100,000 10 $165,000



### Figure 2-7. California gross sales oforganic beets (non-sugar), 2007 Source: Califomia DepartmentofFoodandAgriculture, 2010

Event H7-1 Draft ER 67 Affected Environment 7/28/2010Dul**Ilm!~** , Legend 

# o Less than 1 TuM, 

# o 1to 10**Flun~;;** 10t0100 

# III more than 100**TuIJ·~**

KtHl



### Figure 2-8. California acreage oforganic Swiss chard, 2007 Source: Califomia DepartmentofFoodandAgriculture, 2010

Event H7-1 Draft ER 68 Affected Environment 7/28/2010Legend 

# D Less than $1 ,000 

# D S1,DDDto$1D,DDD**~** $1D,DDDto$1DD,DDD 

## III $100,000to $400,000

Ir:y"



### Figure 2-9. California gross sales oforganic Swiss chard, 2007 Source: Califomia Department ofFoodandAgriculture, 2010

Event H7-1 Draft ER 

### 69 Affected Environment 7/28/2010

### 2.9 NATIVEAND UNCULTIVATED NON-NATIVE BEETS Plants that are native to a particulararea or ecosystem are those that are not introduced by humans, butoccur at those locationswithout human intervention. Non-native beets fall into one ofthree categories: wild plants, weeds and feral beets. Nonnative wild beets arethose thatthatwere never cultivated, and grow on their own outside ofan agricultural/horticultural setting. Weeds, discussed in Section 2.5, included unwanted plants in an agricultural/horticultural setting. Feral beets are those thatwere originally domesticated, but have escaped cultivation and growon theirown. 2.9.1 Native beets No native members ofthe genus 

### Beta are found in North America (USDA, 2010a; Mansfeld, 1986, as reported in DECO, 2001, Table 3). Thus, all ofthe 

### Beta species in North America, both cultivated and uncultivated, were introduced through human intervention from outsidethe continent. 2.9.2 Uncultivatedwild beets in the US 

## Betaspecies in tlte US and potential forhybridization with sligarbeet The USDA reports two 

### Beta species in the US: 

### Beta procumbens and 

### Beta vulgaris. Some researchers (e.g., Bartsch and Ellstrand, 1999; Bartsch et ai, 2003) consider 

### Beta macrocarpa as a separate species; however, USDA ARS reports thatthe designation was changed in 2000 to B. 

### vulgaris ssp. macrocarpa (USDA/ARS, 2010a). B. 

### procumbens can be artificially crossed with sugar beet (a B. 

### vulgaris subspecies), butthe plants usually die at the seedling stage (DECO, 2001, p. 25). In any case, B. 

### procumbus in the US has 

### been identified only in Pennsylvania, where sugar beet is not grown (USDAARS, 2010a). Sugar beet hybridizeswith all B. 

### vulgaris subspecies, including B. 

### vulgaris ssp. macrocarpa. The hybrids are all annuals, flowering inthefirst year and producing little or no root or sugaryield (Messean et ai, 2009, p. 49). 

### B. macrocarpa (or

### B. vulgaris ssp. macrocarpa). There is some scientific disagreement aboutthe compatibility ofsugar beet and B. 

### vulgaris ssp. macrocarpa (referred to hereafter as B. 

### macrocarpa, the terminology in all sources except USDNARS 2010a). DECO reports that B. 

### vulgaris and B. 

### macrocarpa are fully compatible and the resulting hybrids arevigorous and fertile (DECO, 2001, p. 24). In contrast, Dr. R.T. Lewellen, a USDA, ARS geneticistwho has worked with sugar beet atthe USDA/ARS Salinas Research Station for manyyears has done

Event H7-1 Draft ER 70 Affected Environment 7/28/2010research on B. macrocarpa and has concluded that itdoes not outcross readily to sugar beet. This is because B. macrocarpa usually bolts and flowers too early to cause a risk of hybridization with sugar beet. Additionally, any hybrid ofsugar beet and B. macrocarpa would possess several geneticfactors that pose a challenge to the plants' survival in nature. For example, the hybrid would be mostly pollen sterile and would have disturbed genetic ratios and growth habit. Finally, because B. macrocarpa is self-fertile, a cross could only be made with sugar beet by using self-sterile or male sterile sugar beet plants
- something which is unlikelyto occur in nature (Panella, 2003). Other researchers have also found that hybridization between B. macrocarpa and sugar beet is relatively rare because the flowering times usually do not overlap (Bartsch et ai, 2003, p. 108; McFarlane, 1975 as reported in DECO, 2001, p. 24). In addition, based on genetic studies, Bartsch and Ellstrand (1999) report a "strong genetic differentiation between B. vulgaris and B. macrocarpa, which supports the notionthatthe latter is a separate species" and find it "remarkable" that hybridization between the two "is still possible" (pp. 1126 and 1129). Sugar beets have been grown in the Imperial Valley since 1932 (Spreckels Sugar, 2009). As noted above, the earliest dated collected Beta specimen is from 1938; however, Bartch and Ellstrand reference observations of uncultivated wild beets in the Imperial Valley from 1928 (Bartsch and Ellstrand, 1999, p. 1126). When Bartsch and Ellstrand did their research in 1998 and found evidence of introgression between B. macrocarpa and B. vulgaris in two percent of the B. macrocarpa tested, sugar beets had been grown in the Imperial Valley for66 years.

Event H7-1 Draft ER 71 Affected Environment 7/28/2010

### Figure 2-10. All CA counties with beta 

### records Source: Consortium ofCalifornia Herbaria, 2008 

## Uncultivatedwildbeetsin California The USDA/ARS has 13 B. vulgaris var. maritima30 and 7 B. vulgaris ssp. macrocarpa collected specimens in its National Plant Germoplasm System, all donated in 1985 by J.S. McFarlane ofthe USDAARS Salinas, California office. Thetwo B. vulgaris ssp. macrocarpa sampleswith collection information included were both from the Imperial Valley; one was collected from a sugar beetfield in 1968; collection information for the otherwas not noted (USDAIARS, 2010a). The Consortium ofCalifornia, which keeps a database of 16 herbaria (collections ofplant specimens) throughoutthe state, documents 172 Beta accessionsfrom 15 counties, collected between 1896 and 2006 (counties show in Figure 2-10 at left) (Consortium ofCalifornia Herbaria, 2008). Forty ofthe specimens are designated B. macrocarpa, 19 as B. vulgaris ssp. maritima, one simply as Beta, and the rest are designated B. vulgariS. Seventeen ofthe accessions are from Imperial County: 14 of these are designated B. macrocarpa, one is designated B. vulgaris, and onewas originally identified as vulgaris and later corrected to macrocarpa. Imperial County collection dates ranged from 1938 to 1998 (Consortium ofCalifornia Herberia, 2008). Calflora's database includes herberbia records, plus otherdocumented or recorded observations. California counties with records ofB. vulgaris or B. macrocarpa are shown in Figure 2-12, along with sugar beet production areas (shown as blue dots).

30 Specimens were originally identified as Beta vulgaris ssp. maritima Event H7-1 Draft ER 72 Affected Environment 7/28/2010There have been a numberof hypotheses regarding the origin ofthe California uncultivated wild beets, including that at least some ofthem are wild (feral) sugar beets (Johnson and Burtch, 1959, as referenced in Bartsch and Ellstrand, 1999, p. 1120). However, based on genetic analysis, Bartsch and Ellstrand (1999) concluded that the uncultivated wild beets in California have two independent and primary genetic origins, one from European B. macrocarpa (the uncultivated wild beetsfound in the Imperial Valley and on the Channel Islands) and one from European 

### B. vulgaris (beets from all other areas in California where uncultivated wild beets are found). Theyfound thatwhattheytermed the B. macrocarpa ofthe Imperial Valley and the Channel Islandswere, with the exception ofone population, "genetically identical with a Spanish B. macrocarpa from the Mediterranean area ofCartagena" (Bartsch and Ellstrand, 1999, p. 1126). The singe exceptionwas a population in the Imperial Valley ofB. macrocarpa that showed genetic similarities with B. vulgaris, which led them to conclude that the sugar beet (a subspecies ofB. vulgaris) had introgressed with B. macrocarpa (Bartsch and Ellstrand, p. 1126). Bartsch and Ellstrand concluded thatthe other uncultivated wild beets in California are descended from cultivated Swiss chard and red table beets, European sea beets, and hybridized populations among these (Bartsch and Ellstrand, 1999, p. 1128). 

## Uncultivatedbeets in 

## othersugarbeetseedorrootproduction regions
One record for uncultivated B. vulgaris was found for Oregon: a specimen collected in 1998 from Corvallis in Benton County, by AndrewA. Duncan (Rice, 2010). Two records for uncultivated B. vulgariswerefound in Michigan, one ofwhich was in Tuscola County, which is in the Great Lakes Region ofsugar beet production (USDA 2010a). USDA shows five counties in western Montana with B. vulgaris records (Madison, Gallatin, Ravilli, Missoula, Pondera and Cascade), based on Booth and Wright's 1996 Flora orMontana (USDA 2010a). None ofthese counties are in that part of Montana included in the Great Plains Region ofsugar beet production (Figure 2-2). In addition, Rice (2010), a more updated source, shows no Beta records for Montana (2010). While there is widespread information about uncultivated beets in California, no other information wasfound otherthan that summarized here for uncultivated beets in any other sugar beet seed or root production areas. Since these records indicate only "B. vulgaris" it is not possible to determinefrom the information whether these plants are sugar beets or some other subspecies. In addition, USDA has previously concluded that BetaB. vulgaris only poses aweed issue for sugar beet crops in the Imperial Valley ofCalifornia (USDAAPHIS, 2005).
Event H7-1 Draft ER 73 Affected Environment 7/28/2010DEFINITIONS Ecosystem

- the complex of a community of organisms and its environment Species

- graup oforganisms all of which have a high degree of physical and genetic similarity, generally interbreed only among themselves, andshowpersistentdifferencesfrom members of allied graups of organisms. Introduction intentional or unintentional escape, release, dissemination, or placement of a species into an ecosystem as a result a/human activit;y. Native species

- with respect to a particular ecosystem, a species that, other than as a result of an introduction, historicallyoccurred or occursin thatecosystem. Alien species

- with respect to a particular ecosystem, any species, including its seeds, eggs, spores or other biological material capable of prapagating thatspecies, that is not nativeto thatecosystem. Invasive species

- alien species whose introduction does or is likely to cause economic damage or environmental harm or harm to humanhealth. Invasiveplants

- introducedspecies thatcan thrive in areas beyond their natural range ofdispersal. These plants are characteristically adaptable J aggressive, and have 

## a high reproductive capacity. Their vigorcombinedwith a lackof natural enemies often leads to outbreak problems. Sources: Executive Order 13112
- Invasive Species (1999); USDA National Agricultural Library, 2010.

Event H7-1 Draft ER 2.9.3 Weed beets Beets (genus Beta) generally are notweeds: there are no Beta species included in theWeed Science Society of America's (WSSA) list of3,488 weeds (2010a). No Beta species are included among the 1,553 weeds in the USDA database ofinvasive and noxious weeds (USDA, 2010b). 

## Weedbeets in Europeall sugarbeetproduction We discussthe problem ofweed beets in European production fields because it is a concern in Europe and may raise questions about whetherthe same issues may occur in the US, and, ifso, what impactthe use ofevent H7-1 sugar beetwould have. Weed beets have been a serious problem in European sugar beet production since the 1970s (May, 2001; Desplanque et ai, 2002; Ellstrand, 2003). In 2000, some sugar beetfields in the EU were growing more weeds than beets (Ellstrand, 2003). Weeds ofthe same or closely related species as the crop can present special problems. Their seeds and young plants may be indistinguishable, and they will havevery similar responses to herbicides. Unlike sugar beets, the weed beets flower in the first year, and produce many seeds. Because they are the same species, any herbicide that is effective on the weed beet will also damage ordestroy the sugar beet. Thus, theweed beets must be manually removed, and the groweroften does notfind thatthe weed beets are not sugar beets until they bolt. Theweed beets form a seed bank that can persistfor years. While weed beets and native sea beets grow in many parts ofEurope, the weed beets in the production fields apparently do not originate from weeds nearthe production fields. In the 1990s, the



### 74 Affected Environment 7/28/2010problem was traced to hybridization ofweed beets with the sugar beets grown in seed production areas (Ellstrand, 2003, p. 70-73). Sugar beet and sea beet (B. vulgaris ssp. maritima) hybridize freely and the resulting progeny are fully fertile. Sugar beet and sea beet also share a common flowering period. Sugar beets are grown in many parts of Europe, but seed production occurs mainly in thetemperate climate regions ofsouthwest France and northeast Italy, where weed beets are also present (Bartsch etai, 2003). While the sugar beets and weed beets introgress with each other, and theweed beets and the native sea beets that grow along much ofthe Atlantic European and the Mediterranean also introgresswith each other, in a century ofsugar beet production, geneflow from sugar beets has notaltered the genetic diversity ofwild sea beets in the region, including in the seed production areas (Bartsch et ai, 2003). 

## Weedbeets ill 

## theImperial Valley In the US, the only reports ofweed beets as a problem have been in sugar beet production in the Imperial Valley (Lewellen et ai, 2003; Bartsch et ai, 2003; Lilleboe, 2009). The weed beet situation in the Imperial Valley is very differentfrom that in Europe. Theweed beets in Europe originated from seed production fields, where the sugar beet plants and nearby wild beets all flower at the sametime, and the resulting hybrids apparently contaminated the seed supply. Thus, the European weed beets in sugar beet root production fields originated from the inadvertent planting ofthe weed beet seeds along with the sugar beet seeds. In the Imperial Valley, theweed beets are B. macrocarpa, which were present in the Imperial Valley before the introduction ofsugar beets, and have coexisted with sugar beets since 1938with very little hybridization (Bartsch and Ellstrand, 1999; Bartsch et ai, 2003). 

### 2.9.4 Feral crops Based on available data, de-domestication has occurred in only afew crops. These feral crops are ofminor importance compared with otherweeds (Gressel, 2005). In North America, the feral plants that cause much ofthe economic damage are imported horticultural plants; for example, Japanese privet (Ligustrumjaponicum),Japanese honeysuckle (Lonicerajaponica) and kudzu (Pueraria lobata) (Gressel, 2005). Scientists from Oregon State University reportthatthere are no feral sugar beet crops in the US (Mallory-Smith and Zapiola, 2008, Table 1). As discussed in Section 2.5.3, in California, the only sugar beet growing state with documented beet populations (as opposed to the isolated

Event H7-1 Draft ER 75 Affected Environment 7/28/2010

### reports from afew other locations), genetic assessment ofuncultivated wild beets has not supported the conclusion that any ofthese beets are feral crops. Based on this information, and the poor competitive characteristics ofsugar beets, we have concluded that the existence offeral sugar beet crops in the US is unlikely, and any that might exist are negligible. 

### 2.10 FOOD AND FEED USES OF SUGAR BEET In addition to producing granulated sugar, sugar beet processing facilities produce a co-product known as dried beet pulp. Pulp is the dried fiber residue left after most ofthe sugar has been extracted from the sliced beets. Dried beet pulp is typically sold as either a shred (with or without molasses added) or in pellet form foranimal feed. Beet molasses is produced in quantities ranging from 4 percent to 5 percent ofthe weight ofthe beets and contains about 50 percent sugar. Beet molasses is used for production ofyeast, chemicals and pharmaceuticals, as well as in the production ofmixed cattle feeds (Southern Minnesota Beet Sugar Cooperative, 2010a). Multiple countries that regulate the importation ofbiotechnology-derived crops and derived products have granted regulatory approval to event H7-1 sugar beets forfood and feed uses, including Japan, Canada, Mexico, European Union, South Korea, Australia, NewZealand, China, Colombia, Russian Federation, Singapore, and the Philippines (FSANZ, 2005; Monsanto/KWS 2007; Berg 2010). Canada and Japan have also approved event H7-1 sugar beets for cultivation in those countries (Sato, 2008; CFIA, 2005). 

### 2.11 PHYSICAL AND BIOLOGICAL ISSUES The affected environmentfor land use, air quality, water quality, ecology, threatened and endangered species, and other sensitive wildlife is the area in the sugar beet root producing areas (shown in Figure 2-1) and in the seed producing region in the Willamette Valley, the seed producing region (Figure 2-4). The affected environmentfor climate is global, as impacts on climate change are global issue. 

### 2.12 SOCIOECONOMICS AND HEALTH The affected environmentfor socioeconomic issues includesthose individuals orgroups who could be economically impacted iftheirfood, feed, oragricultural products are adversely affected by event H7-1. It also includesthose who would be economically impacted ifevent H7-
Event H7-1 Draft ER 

### 76 Affected Environment 7/28/2010

### 1 becomes a regulated article: growers ofevent H7-1 sugar beets, sugar processors, seed companies, and sugar marketers and sugar buyers. Potential impacts to the first group are discussed primarily in Section 3.11 and impacts to the second group are discussed in Section 3.16. The potential forhealth impacts to individualswho may come into contact with glyphosate-tolerant sugar beets or beet seeds, or sugar orother products derived from glyphosate-tolerant sugar beets is discussed in Sections 3.11 and 3.15. Health effects of potential exposure to herbicides are discussed in Section 3.15.

Event H7-1 

### Draft ER 77 Affected Environment 7/28/2010

### ENVIRONMENTAL CONSEQUENCES

Section 3 ofthis ER examines the possible impacts ofa partial deregulation of H7-1 or similar administrative action. 

### 3.1 PLANT PEST PROPERTIES AND UNINTENDED EFFECTS APHIS previously determined, based on scientific analysis and in accordance with its obligations underthe Plant Protection Act, that sugar beet event H7-1 is not a plant pest and does notexhibit plant pathogenic properties (USDAAPHIS, 2005). APHIS considered the potential forthe transformation process, the introduced DNA sequences, ortheir expression products to cause oraggravate disease symptoms in sugar beet event H7-1 and its progeny or in other plants. APHIS also addressed the potential for event H7-1 to become a weed or make other plants that it breedswith into weeds. APHIS also considered whether data indicatethat unintended effects would arise from engineering ofthese plants. APHIS considered information from the scientific literature as well as laboratory and field data collected during thetrials with event H7-1 thatwas provided by Monsanto/KWS in its petition (included in Schneider, 2003). Based on the analysis summarized below, there are no impacts resulting from plant pest properties, introduced or aggravated disease symptoms, or unintended effects underany ofthe alternatives. Details ofthe Monsanto/KWS studies are included in the petition (Schneider, 2003). 3.1.1 Background 

## Plantgeneticmodification Plant genetic modification by humans ranges from the simple approach ofselection
- where seeds of plants with desired traits are saved and replanted
- to complex methods such as the use of recombinant DNA (rONA; see definitions on next page). Crossing (and then recrossing) two sexually compatible plants by taking the pollen from one plant and brushing it onto the pistil ofanother is still the mainstay of modern plant breeding (1M/NRC, 2004). Both conventional breeding and rONA methods can involve changes in the sequence, order, and regulation of genes in a plant and can use many ofthe same enzymes. However, with conventional breeding all the tens ofthousands ofgenes in the plant are involved, and withthe rONA method only a few genes are involved. In classical breeding, crosses can be accomplished only between closely related species, and therefore only traits that are already present in those species can
Event H7-1 Draft ER 78 Environmental Consequences 7/28/2010

### be targeted. In contrast, the rDNA approach can use genes from any living organism, thus opening the doorto vast potential in trait development (Lemaux, 2008, p. 774; AMA,2000). Other examples ofplant genetic modification include cell fusion (the protective cell wall is stripped and cells are fused by some external force) and induced mutagenesis (inducing mutations in seeds by ionizing radiation or carcinogenic chemicals) (Ronald and Adamchak p. 88). Mutagenictechniques, which have been in use since the late 1920s, create random mutations and are limited by their inabilityto target a desired trait (FDA, 1992; Lundqvist, 2009, p. 39). 

### Agl'obactel'iul1l Agrobacterium tumefaciens (Agrobacterium) is a soil microbe that has been called "nature's own genetic engineer" because of its ability to transfer afragment ofits own DNA into a host plant (AMA, 2000). (See definitions at right.) The transferred DNA is stably integrated into the plant DNA, and the plant incorporates and expresses the transferred genes. The transferred DNA (T-DNA) reprograms the host plant cells to grow into callus tissue and produce certain amino acid derivatives that are a food source forthe Agrobacterium. On a macro scale, the callus tissue growth is called crown gall disease. In the early 1980s scientists developed strains ofAgrobacterium with T-DNA that lacked the disease-carrying genes ("disarmed" Agrobacterium). Agrobacterium transformation system has been utilized in the developmentofa large number ofgenetically engineered plants in commercial production (1M/NRC, 2004, pp. 28- 29). The method uses a DNA molecule called a vector

Event H7-1 Draft ER 79 DEFINITIONS Nucleotide

- basicbuildingblockof nucleicacidssuch asDNA. Each nucleotideismadeupafa**nitrogen~** containinggroup, asugar, anda phosphategroup. Nucleicacid

- achain of nucleotides. DNA - deoxyribonucleicacid

- a typeof nucleicacidthatactsasthe geneticmaterialin mostliving things. Chromosome- a DNA molecule containingall orpartsof the genomeo/an organism, which has theabilityto replicate. Genome- the completesetof genes in an organism. Gene

- thebasic unitof heredity; it isasegmentof DNA on aspecific siteon achromosome. Aminoacid

- oneof20chemical buildingblocksforproteins; there arealsononproteinaminoacids. Cotalyst- achemicalthatspeeds upachemicalreactionbutisnot changedbythechemicalreaction. Enzyme

- abiologicalcatalyst; usuallyaprotein. RecombinantDNA(rDNA) techniques- proceduresusedto join togetherDNA segments. Under appropriateconditions, a rDNA moleculecan enteracelland replicate there. Mutation

- any change in the base sequenceof DNA. Diploid

- containing two sets of chromosomes {one from each porentO. Sources: Sadava, 2008; 1M/NRC, 2004; biology online; GMO Safety, 2010a.

Environmental Consequences 7/28/2010that serves as a carrierto insertT-DNAthat contains specific genetic elements. These genetic elements are organized into a gene cassette, which consists ofa gene encoding for a single biological function plus other genetic elements necessary for the expression ofthat genewhen introduced into the plant. Other elements in the gene cassette include a promoter, which can bethought ofas the "on switch" forthe gene encoding forthe desired trait; and atargeting sequence, which makes surethe gene product, typically a protein, ends up in the right location within the cell (such as the chloroplast). 

## Unintendedeffects/1'0111 

## breeding Mostcrops naturally produce allergens, toxins or other antinutritional substances; these often serve the plant as natural defense compounds against pests or pathogens (FDA, 1992). Plant breederstypically monitorthe levels ofantinutritional substances relevantto their crop. For example, solanine is a naturally-occurring toxin produced by potatoes and is part ofthe plant's defense against insects and fungus. Potato breederstypically monitorsolanine levels and reject lines that generatetoo much of it (1M/NRC, 2004). Scientistsfrom the Institute of Medicine (1M) and the National Research Council (NRC) ranked breeding methods according to their relative likelihood ofproducing unintended effects, which they hypothesized would correspond to the degree ofgenetic disruption associated with the method. Selection from a homogeneous population was ranked at one end ofthe spectrum (less likelyto produce unintended effects) and induced mutagenesis (from chemicals or radiation) was ranked atthe other end (more likely). Agrobacterium transfer ofrONA was among the methods ranked in between (1M/NRC, 2004, Figure ES-1). Recent studies in Europe comparing transgenic and conventional barley suggestthat conventional breeding may cause more unintended effectsthan rONA methods, likely because ofthe very large number ofgenes that are affected in conventional breeding techniques (Sonnewald, 2010). These results are consistentwith those observed byAPHIS with event H7-1 and many other plants produced through rONA methods: exceptfor the intended trait, the GE plant is found to be substantially equivalentto its non-GE counterpart. 

## Glyphosatetolerance As discussed in Section 2, glyphosate acts by inhibiting the action ofthe enzyme 5- enolpyruvylshikimate-3-phosphate synthase, EPSPS, in plants. EPSPS is a catalystfor a reaction necessaryforthe production ofcertain amino acids essential for plant growth. When

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### 80 Environmental Consequences 7/28/2010plants are treated with glyphosatethe EPSPS enzyme is inhibited, they cannot produce the amino acids needed for continued growth and eventually die. The EPSPS protein and the reaction it catalyzes are present in all plants and microbes. There are variations in the amino acid sequence of EPSPS among different plants and bacteria. Glyphosatetolerance is achieved by introducing an EPSPS enzyme, termed CP4 EPSPS, that is not inhibited in the presence ofglyphosate. An Agrobacterium strain (designated CP4) was the source ofthe cp4 epsps gene that encodes for the CP4 EPSPS enzyme (Schneider, 2003). The CP4 EPSPS enzyme carries outthe same enzymatic reaction in the plant as the native EPSPS; however, when plants that contain the CP4 EPSPS are sprayed with glyphosate, they are ableto continue to produce the essential amino acids needed for plant growth. The objective ofthe genetic modification in event H7-1 wasto simplify and improveweed management practices in sugar beet by conferring tolerance to glyphosate. 

## Tralls/ormatiollsystem Event H7-1 was developed using a disarmed Agrobacterium-mediatedtransformation ofa sugar beetvariety used in plant breeding. Cotyledons (part ofthe seed embryo) derived from sterile seedlings ofthe diploid sugar beet line 3S0057 were used as the explant source. An explant is any portion ofa plantthat is to be used to initiate culture. These cotyledons were immersed in an Agrobacterium suspension and co-cultured fortwo to four days. The explantswerethen transferred to selective media containing 500 mg/l carbenicillin to eliminatethe Agrobacteria. Glyphosatewas used for selection ofglyphosate-toleranttissue, with tissue containing a genetic insertion to confer glyphosatetolerance assigned a unique number, such as event H7-1. After approximately seven weeks, the developed plantlets were transferred to rooting media and placed in a greenhouse. All subsequently developed event H7-1 sugar beet breeding lines and variety candidates were derived by traditional plant-breeding methods (Schneider, 2003, pp. 20- 21). 

## DNAsequellcesillsertedilltosligarbeetevelltH7-1 Data supplied in the petition and reviewed by APHIS (Section 

### VA, pp 29-44) supportthe conclusion that event H7-1 contains the following gene cassette: 1) a promoterfrom a modified figwort mosaic virus, 2) targeting sequencefrom the plantArabidopsis thaliana,

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### 3) the EPSPS genefrom Agrobacierium sp. strain CP4, and 4) a portion ofa gene from pea that directs genetic processing This same gene cassette is present in other Roundup Ready® cotton and canola, which have previously been deregulated by USDA (Schneider, 2003, p. 24). The non-coding promoter is from the plant pathogen figwort mosaic virus. The promoter cannot cause plant disease and serves a purely regulatory function forthe EPSPS gene. The CP4 EPSPS gene does not cause disease and has a history ofsafe use in a number ofgenetically engineered plants (e.g., corn, cotton and soybean varieties). 3.1.2 Evaluation of intended effects 

## Analysis of inheritance Data was provided and reviewed by APHIS that demonstrates stable integration and inheritance ofthe EPSPS gene cassette over several breeding generations. Statistical analyses showthat glyphosatetolerance is inherited as a dominanttrait in a typical Mendelian manner (Schneider, 2003, Table V-2, pp. 45-46). 

## Analysisof genee:'(pression The level of CP4 EPSPS protein was determined from tissues collected from field trials with event H7-1 conducted at several locations. Using standard laboratorytechniques, protein concentrations from H7-1 beet leaves and processed roots (brei) were determined (Schneider, 2003, Table V-3, p. 50). EPSPS proteins are ubiquitous in plants and microorganisms and have not been associated with hazards from consumption orto the environment. Crops that contain the CP4 EPSPS protein have been granted non-regulated status have included corn, soybean, cotton, rapeseed and sugar beet (USDA APHIS, 2010a). In 2009, significant acreages ofcorn (59 million acres or 68% ofthe total corn acres), upland cotton (6.3 million acres or71% ofthe total cotton acres) and soybean (70.5 million acres or 91% ofthe total soybean acres) grown in the US were planted with herbicide tolerant varieties (USDA NASS, 2010c). Although the data include all herbicide tolerantvarieties, glyphosatetolerant ones (containing CP4 EPSPS) predominate. All have also undergone FDA review (FDA, 2010). 

## Analysisof theintendedtrait Numerousfield trials were conducted in the US (Schneider, 2003, Tables VI-4 to VI-6) and in Europe (Schneider, 2003, TableVI-7) to evaluate event H7-1 in different genetic backgrounds

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### and in different environments. Standard field trials evaluated 1) agronomic performance, 2) disease and pest resistance performance, 3) steckling (seedling) production and 4) seed multiplication. Standard industryfarming practices forthe various locales was used in these trials. These practices would typically include control measuresforweeds, diseases and insects. Where glyphosatewas used in trials, no negative impactsfrom application glyphosate were noted. 3.1.3 Evaluation ofpossible unintended effects 

## Diseaseand pestsusceptibility In trials conducted from 1998 to 2002, qualitative and quantitative data addressing disease susceptibility and overall agronomic performance ofevent H7-1 were collected to assess possible effects from introduction ofthe CP4 EPSPS gene cassette. As summarized below, information collected from these trials indicatethat event H7-1 does not altersugar beet's susceptibilityto diseases and pests. Experience in production fields since 2007 supports this conclusion. Nurserytrials in US. 

### During the 2000 and 2001 growing seasons, quantitative datawas collected from variety trials at Betaseed nurseries for comparison ofvarieties with event H7-1 to conventional varieties for relative resistance to four common sugar beet diseases: Cercospora 

### leafspot, Aphanomyces 

### root rot, Rhizoctonia 

### root rot, and curly top virus. In these trials, results ofseason-long testing for disease susceptibility from oneto three varieties with the H7-1 event were compared with four conventional varieties. The results indicated that the disease susceptibility ofthe H7-1 varieties was within the range ofthe conventional varieties (Schneider, 2003, Section A.1). Field trials in US. 

### A total of98 separate Monsanto/KWS field trials were conducted in the US from 1998 to 2002 included comparative evaluation ofsusceptibility to the four diseases evaluated in the nursery trials, plus several fungal seedling diseases and Rhizomania (Schneider, 2003, Section VI.A.2). Together, these are the majordiseases ofeconomic importance affecting sugar beet production in the US (Schneider, 2003, p. 60). At all but six trial locations there were no differences observed between the event H7-1 varieties and the conventional comparators. At onetrial site increased susceptibility to powdery mildewwas noted while at three other sites decreased susceptibilitywas noted. Attwo trial sites increased susceptibility to Cercospora 

### leafspotwas also noted. Given the interactions between the environment, the genetic backgrounds ofthe cultivars used and some inherent genetic

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### variability within sugar beet varieties, these results are not unexpected and do not indicate an increased pest risk. A similar likely insignificant difference was noted in a greenhousetrial using different Fusarium 

### fungus isolates. Other researchers have suggested that it may be difficultto predict field results from greenhouse/laboratory experiments control lines ordifferences outside the range ofconventional sugar beet norms. Field trials in 

### Europe. Additional field trials were conducted with event H7-1 in Europe in 1998 and 1999 and monitored for several diseases and nematode worms. No diseases or nematode symptoms were reported in any ofthe trials for eitherevent H7-1 or conventional control sugar beets (Schneider, 2003, Section A.3). 

## Genesilencing In evolutionary biology, a homologous trait is one derived from a common ancestorthat appears in multiple species. Homology may be manifested on a macro scale, forexample, in the similarity in mammal forelimbs, and on a genetic scale, in DNA sequences. AI-Kaff, et al.(1998) have noted gene silencing effects when transgenic plants have been infected by a virus with DNA sequence homologyto a portion ofthe introduced genes. The only virus-derived DNA in the event H7-1 gene cassette is the promoter, which is from thefigwort mosaic virus. None of the viral diseases ofbeet is related to figwort mosaicvirus (Whitney and Duffus, 1986) so silencing ofthe EPSPS gene would not be expected, and has not been observed. 

## Compositionalevaluation Monsanto/KWS compared the composition ofevent H7-1 sugar beets with conventional sugar beets derived from the same parent line ("near isogenic control line"). To eliminate the influence ofnormal geneticvariation between different hereditary lines and varieties, isogenic lines are usually used as a standard for comparison (GMO Safety, 2010a). The analysis ofH7-1 sugar beets for compositional changes was included in Section VI.C ofthe petition (Schneider, 2003) and was also part ofthe Monsanto/KWS submission to FDA in the consultation process (See Section 3.11 for a discussion ofthe FDA consultation process and results). While FDA uses these data as indicators ofpossible nutritional changes, APHIS views them as a general indicator ofpossible unintended changes. Compositional analyses evaluating carbohydrates, proteins, fiber, fat, sugars, the antinutrient saponin, and eighteen amino acids (a total of55 statistical comparisons) in tops (leaves) and roots (brei) identified seven statistically differentvalues compared with the near isogenic control line. All analyses fell within the range ofvalues observed for both the near isogenic control line Event 

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### and conventional sugar beetvarieties, providing additional evidence that event H7-1 sugar beet does not exhibit unexpected or unintended effects (Schneider, 2003).



### 3.2 WEEDINESS PROPERTIES, VOLUNTEERS AND FERAL CROPS This section addresses two questions: 1. What are the weediness properties ofsugar beet? 2. Is the event H7-1 sugar beet more likelyto become a weed than a conventional sugar beet? 3.2.1 Weediness properties ofsugar beet As discussed in Section 2.5, sugar beets (8. vulgaris) 

### are poor competitors with both weeds and other crops (i.e., beet can compete onlywith members oftheir own species). This is discussed in Section 3.8. 3.2.2 Event H7-1 sugar beetand weediness Some scientists, for example, Ellstrand, 2006, have raised the question of"unintended crop descendents from transgenic crops." Ellstrand states (p. 116): "The possibility ofunintended reproduction by transgenic crops has raised questions about whether their descendents might cause problems. These problems havefallen into two broad categories: first, the directferal descendents ofthe crops may prove to be newweeds or invasive plants, and second, that unintended hybrids between transgenic crops and other plants could lead to certain problems." This section discusses the weediness properties ofH7-1 sugar beet, and addresses the concern ofdirect descendents ofthe crop that "may prove to be newweeds or invasive plants." Hybridization is addressed in several later sections. Event H7-1 was field tested in North America from 1998 to 2003 and in Europe from 1998 to 1999. In these trials, no differenceswere observed between H7-1 lines and non-transgenic lines with respectto the plants' ability to persist orcompete as a weed (Schneider, 2003; USDA APHIS, 2005). In these evaluations, APHIS considered data relating to plant vigor, bolting, seedling emergence, seed germination, seed dormancy and other characteristics (USDA APHIS, 2005). In a separate evaluation, the Canadian Food Inspection Agency (CFIA), whose responsibilities include regulation ofthe introduction ofanimal food and plants (including crops) to Canada, reached the same conclusion aboutthe weediness potential ofevent H7-1 compared with nonEvent H7-1 Draft ER 

### 85 Environmental Consequences 7/28/2010transgenic sugarbeet. In 2005,the CFIA authorized the "unconfined release into the environment and livestock feed use ofthe sugar beet event H7-1" (CFIA, 2005). In its evaluation ofevent H7-1, CFIA "determined that germination, flowering, rootyield, susceptibility to plant pests and diseases typical to sugar beet and bolting percentage were within the normal range ofexpression ofthese traits currently displayed by commercial sugar beet hybrids" (CFIA, 2005). The CFIA reached the following conclusions (CFIA, 2005):
No competitive advantage was conferred to these plants, otherthan that conferred by tolerance to glyphosate herbicide. Resistance to Roundup® agricultural herbicideswill not, in itself, render sugar beet weedy or invasive of natural habitats since none ofthe reproductive or growth characteristics were modified. The above considerations, togetherwith the factthatthe novel traits have no intended effects on weediness or invasiveness, led the CFIAto conclude that the H7-1 sugar beet event has no altered weed or invasiveness potential compared to currently commercialized sugar beet. Thus, the potential for event H7-1 to become aweed or invasive plantwas determined to to be no greaterthan conventional sugar beets. Neithersugar beets or other beta species plants are considered aweed issue in any state otherthan California.
3.2.3 Sugar beetvolunteers Volunteers, which are plants from a previous crop that are found in a later crop, may result from bolters or groundkeepers. Referto Section 2.3.4 for a detailed discussion. 

### Root productio11 While several scientists have reported thatvolunteer glyphosate tolerant plants could in theory become a problem in rotational crops when both rotational crops are glyphosatetolerant, none provided specific information or data relevant to sugar beets (e.g., Cerdeira and Duke, 2006; Owen and Zelaya, 2005; York etai, 204; NRC, 2010). Since sugar beet is grown forthe vegetable and notthe seed, volunteers in a root crop could occur only from the rare plantthat has bolted, ifit is allowed to goto seed. Groundkeepers are cold sensitive and only rarely survive winter conditions in mostsugar beet production areas (Grant, 2010,p. 7; Cattanach etai, 1991; Panella, 2003). As discussed in Section 2.3.4, bolters depletethe sugar content ofthe root and cause problems with harvesting. Thus, good management practices and the grower's own interest dictate removal of bolters. Sugar beetvarieties are specifically bred to make bolters rare. Volunteers
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### are unlikely even if bolters are not removed because a series ofunlikely events must each coincide to produce volunteers. Ifa bolter is not removed, it must be pOllinated by another bolter, and be allowed to go to seed; the seed must then survive the winterfreeze and germinate. And even ifthis does occur, the resulting volunteerwould need to successfully compete with the next year's crop, and could be controlled by mechanical means or by several registered herbicides otherthan glyphosate thatcan be used on sugar beet volunteers (Meister, 2009). Depending on the rotation crops chosen to follow sugar beet (in the normal 3-4 year rotation), growers can use tillage and/or herbicides. Examples ofsome herbicides are methylsulfuron methyl, 2,4-dichlorophenoxyacetic acid (2,4 D) and 3,6-dichloro-o-anisic acid (dicamba) forthe control ofany volunteers priorto planting and after crop emergence. 

## Seed 

## production Control ofvolunteers is more ofa concern with seed production, for both conventional and event H7-1 sugar beet, to maintain seed purity. As discussed in Section 2.7.3, WCBS and Betaseed control all seed production in the Willamette Valley. WCBS has detailed requirements in it protocol (in Appendix B ofthis ER) for post-harvestfield management. After harvesting, the fields are shallowtilled and irrigated to promote sprouting ofshattered seeds (unless sufficient rainfall to promote sprouting has occurred). Fall plowing is not allowed. Afterthe seed is allowed to sprout, it is controlled by herbicides or other means. All equipment is cleaned according to WCBS procedures before it leavethe fields. Fields used for growing event H7-1 are inspected by WCBS "for a minimum offive years or until no volunteers are noted (Appendix B). Betaseed has similar requirements. 3.2.4 Impactsummary 

### Alternative 1 UnderAlternative 1, there would be no impactfrom event H7-1 1 on weediness orvolunteers. 

### Alternative 2 Weediness properties. Based on the information summarized in the subsection, APHIS has concluded that sugarbeet does not exhibit weediness properties, and that event H7-1 does not exhibit any altered weediness properties when compared with conventional sugar beet. Therefore, Alternative 2would not impactthe weediness characteristics ofsugar beet. Feral crops. As explained in Section 2.9, the existence offeral sugar beet crops in the US is highly unlikely, and any population that may existwould be negligible. Because there are no
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### Environmental Consequences 7/28/2010known orsuspected feral crops ofsugar beets in the US, Alternative 2 would not impactferal sugar beet crops. Volunteers in root crop fields. Volunteers resulting from root crops are generally not a concern becausethe crop is harvested in thevegetative stage, bolters are generally rogued (removed), and the occasional volunteerwould be unlikelyto survive thewinterfreeze and could be controlled by other meansthan glyphosate. The interim measures further reduce the potential for any volunteers resulting frorn a root crop by requiring complete control ofbolters. Underthe proposed interim measures, all event H7-1 root crop growers will have measures in placethat require them to survey, identify, and eliminate any bolters in their root crop fields before they produce pollen or set seed (Item 5). Therefore, no or negligible impactsfrom event H7-1 volunteers in root crop fields would be expected underAlternative 

### 2. Volunteers in seed production fields. Managing volunteers in seed production fields is an important part ofseed growers' efforts to maintain seed purity. WCBS and Betaseed have protocols in place to force same-year sprouting ofseed left behind in the production field, plus long-term monitoring (five years forWCBS) of production fields to identify and remove any volunteers. The interim measures contain a universal requirementto force same-year sprouting, ofanyevent H7-1 seed left behind in the production field, and subsequent removal and destruction of plants (item 4.j); 3-year monitoring offields forvolunteers along with removal and destruction (Item 4j); employeetraining (Item 4k); recordkeeping to documentcompliance (item 4m); and third-party audits for compliance (Item 7). Given the existing industry standards coupled with the mandates ofthe interim measuresto control volunteers, no or negligible impactsfrom event H7-1 volunteers in seed production fields would be expected under Alternative 2. 

### 3.3 IMPACTS OF EVENT H7-1 SUGAR BEET ROOT CROPS ON CONVENTIONAL SUGAR BEET CROPS This section considers the possibility of impacts from event H7-1 sugar beet crops on conventional sugar beet crops through geneflow (refer to Section 2.4 for a general discussion ofgeneflow), or by mixing in harvesting, transportation, stockpiling, or processing.


### 3.3.1 Pollen sources in production fields As discussed throughoutthis document, in production fields sugar beets are grown fortheir roots and are harvested before theyflower. The only sources ofevent H7-1 pollen in production

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### fields would be from uncontrolled bolters. Referto Section 2.3.4 fora detailed discussion of bolting. 3.3.2 Potential for geneflow in root production fields Because sugar beets are harvested in the vegetative stage, before they flower, there is little potential for cross-pollination between root production fields. Cross-pollination, ifit occurred could potentially result in adventitious (inadvertent) presence ofgenetic material from the crop in one field into a nearby crop's field. Scientists from Oregon State University report that for sugar beet "geneflow via pollen or seed in root production fields is generally not an issue" (MallorySmith and Zapiola, 2008, p. 433). Messean etal concur: "the potential for adventitious presence ofGM material in non-GM sug81 heet production is low through**cross-polli~ation** 

### since the harvest is vegetative" (2009, p. 49). The**Eur~pean** 

### Commission (the executive body ofthe 

### European Union [EU]) Scientific Committee on Plants (2001) also :Jssessed the potential for adventitious presenceofevent H7-1 sugar beet at various stages offarm production. The Committee identified seed production asthe major potential source ofadventitious presence, with other sources, including planting, cultivation, cross-pollination, volunteers, harvesting and production all with no or minor potential contributions (p. 8). Because pollen dispersal is a concern with sugar beet seed production, it is discussed in detail in the analysis ofimpacts in seed production (Section 3.9). The Section 3.9 discussion evaluates distances overwhich cross pollination may occur; this is an issuewith little relevance to root production. 3.3.3 Potentialfor mixing ofevent H7-1 and conventional sugar beets As discussed in Section 2.2, 95 percent ofsugar beet seeds planted in the US in 2010 were glyphosate-tolerant. Except in California, where only conventional sugar beet has been grown to date, production, processing and rnarketing within the industry no longer distinguishes between event H7-1 and conventional sugar beet crops-they are processed and marketed together. The 22 sugar beet processing facilities in the US process a cornbination ofevent H7-1 and conventional sugar beets. As discussed in Section 2.3, no currently operating sugar beet processing facilities have been built in the US since 1975. Because a processing facility is required for sugar production, the 22 processing facilities accountfor all the beet sugar produced in the US. Markets have been available forthe sugar, beet pulp, molasses and other products (Kaffka and Hills, 1994, p. 2; California Beet Growers Association, 1998; Western Sugar Cooperative, 2006a; Michigan Sugar Company, 2010b; American Crystal Sugar

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### Company, 

### 2009; Minn-Dak Farmers Cooperative, undated; Snake River Sugar Company, 

### 2009). 3.3.4 Consequences ofgene flow in productionfields We have found no reports of cross-pollination between event H7-1 sugar beet root production fields and conventional sugar beet crops since event H7-1 sugar beets were first grown in production fields in limited quantitiesthe US in 

### 2006. As discussed above, because sugar beets are harvested in the vegetative stage, bolters are uncommon, and it is good management practiceto remove bolters, pollen movement, orgene flow between event H7-1 and conventional crops is expected to be minimal. If bolters occurred in two nearbyfields, one with event H7-1 and one with conventional sugar beets, and the bolters were not controlled and were allowed to flower, a conventional plant could potentially become fertilized with event H7-1 pollen, and the resulting seeds may contain the event H7-1 trait. This occurrence would notaffect the conventional sugar beet crop because itwould be harvested before these new resulting seeds grew into sugar beet plants, if they did. Ifthe seeds germinated and the resulting plants survived the winter, which is unlikely in most sugar beet production areas, the volunteer plants would appear in the conventional sugar beet farmer's next rotational crop, and (ifthey survived) would be treated as weeds, as described in Section 

### 3.3, and would be eliminated. There is evidence that growers pay close attention to bolters. All growersthat submitted declarations in the sugar beet litigation declared that bolters are easy to spot in theirfields and if seen theywould destroythem. There is no evidence thatwe have seen to the contrary. Any conventional sugar beet grower concerned aboutthis occurrence could prevent it by controlling bolters in his sugar beet crop, which is normally stewardship for any sugar beet crop. 3.3.5 Potential consequences from mechanical mixing With the exception ofthe Imperial Valley where only conventional sugar beets have been grown, grown, commingling ofharvested beets from H7-1 seed and conventional seed has occurred since 

### 2007, with no consequences.

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### 3.3.6 Impact Summary 

## Altemative1
UnderAlternative 1, there would be no gene flow impactfrom event H7-1 root crop production to conventional sugar beet crops. 

## Altemative2 Gene flow. Even withoutthe interim measures, impacts from event H7-1 sugar beet root crops to conventional sugar beet root crops have notoccurred and would not be expected because: 1) sugar beets are harvested in the vegetative stage, before they flower; 2) if bolting and crosspollination occurred in nearbyfields, the root crop would not be affected; 3) any conventional growerwho wanted to be certain ofpreventing cross pollination could do so by controlling bolters in his own root production fields; 4) a volunteer event H7-1 hybrid appearing in a subsequent crop resulting from cross pollination in root production fields can be controlled using standardweed control practices and would not likely survivethewinter in mostgrowing areas in any event. The interim measuresfurther reduce the potential forgeneflowfrom event H7-1 root crops to conventional root crops by requiring complete control of bolters. Underthe proposed interim measures, commercial event H7-1 root crop growerswill have measures in placethat require them to survey, identify, and eliminate any bolters in their root cropfields beforethey produce pollen orsetseed (Item 5). Item 6 ofthe interim measures requires event H7-1 processors or cooperatives to survey, identify, and eliminate any bolters in outdoorstorage before they produce pollen orsetseed. Therefore, no or negligible impacts from gene flowfrom event H7-1 sugar beet root crops to conventional sugar beet root crops would be expected under Alternative 2. Mixing of harvested beets. Currently, by mutual agreementamong growers, cooperatives, processors and marketers, event H7-1 sugar beets and conventional sugar beets are harvested, transported, stockpiled, processed and marketedwithout distinction in all areas except California, where event H7-1 sugar beet has not been grown. No impacts have occurred and none are expected. Through the interim measure (Item 1) prohibiting planting ofevent H7-1 in California, this status quo will be maintained. Therefore, underAlternative 2, no impacts are expected resulting from mechanical mixing ofevent H7

### -1 and conventional sugar beets.

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### 3.4 IMPACTS OFOF EVENT H7-1 ROOT CROPS ON ORGANIC SUGAR BEET CROPS Based on all available information, we have concluded that there is essentially no organic sugar beet production in the US. The only reference to organic sugar beet production we found was from the State ofCalifornia, where 0.02 to 0.03 acre ofsugar beet production in Los Angeles County was reported from 2002 to 2007, with most recent annual sales offive dollars (California Department ofFood and Agriculture, 2010). California is by farthe largest producer oforganic commodities in the US, accounting forapproximately one-third ofsales in 2008 (USDA, 201Oc, Table 1). USDAtracks production ofa number oforganic crops, but not organic sugar beets. Although no other information wasfound, similar production may be occurring in other states. We have found no other information about organic sugar beet production in the US. As discussed in Section 2.3, all the commercial sugar beet grown in the US is processed into sugar at one ofthe 22 processing facilities, none ofwhich process organic sugar beets. 3.4.1 Impact

### summary Based on the above discussion, neither alternative would be expected to result in impactsto organic sugar beet production, becausethere is essentially zero organic sugar beet production in the US. There is a substantial European organic sugar beet business, and American organic farmers may in the future decide to grow organic sugar beets. This would most likely be small-scale production, as no processing facility would be available. The presence ofevent H7-1 sugar beetwould not inhibitthe development ofan organic sugar beet industry. As discussed in Section 3.4, a grower oforganic sugar beets could ensure no cross-pollination from event H7-1 fields by controlling any bolters in his sugar beet crop. As discussed in Section 3.9, organic sugar beet seed is available from European suppliers. Therefore, Alternative 

### 2 is not expected to result in impactsto organic farmers who may chooseto growsugar beets in the future. 

### 3.5 IMPACTS OFOF EVENT H7-1 ROOT CROPS ON OTHER BETA (NON

## SEED) CROPS The cultivated forms of

### B. vulgaris, including sugar beet, red table beet, Swiss chard, and spinach (leaf) beets are all varietal members ofthe subspecies vulgaris (B. vulgaris ssp. vulgaris) (OECD, 2001, Table 2). They are all biennial and all are sexually compatible with sugar beets (OECD, 2001). Whether grown for leaves or roots, beet crops are all harvested in theirfirstyear before they produce seed. In addition, as discussed in Section 2.8.1, there is Event H7-1 Draft ER 

### 92 Environmental Consequences 7/28/2010virtually no overlap between sugar beet root production areas and major areas ofproduction of other Beta crops. Mostgrowers purchase seed fortheirtable beet crops; however, a few organic gardeners may allow part oftheir crop to vernalize then to goto seed and then save the seed for replanting. Ifa sugar beet production root crop was grown close to a table beet crop thatwas allowed to go to seed and the sugar beet crop had uncontrolled bolters thatflowered atthe same time asthe other beet crop, there would be some very small potential for hybridization between the sugar beet and other beet. Based on the discussion in Section 3.3, this occurrence would be expected to be exceedingly rare and unlikelyto occur. The situation would be no differentfor event H7-1 orconventional sugar beet. There is no indication thatthis has occurred since wide scale H7-1 beet root production began in 2008. 3.5.1 Impactsummary 

## Alternative1 UnderAlternative 1, there would be no impactsfrom event H7-1 root crop production on other Beta crops. 

## Alternative2 Assuming no interim measure provisions, impacts from event H7-1 sugar beet root crops to conventional sugar beet root crops have notoccurred and would not be expected because: 1) sugar beets are harvested in thevegetative stage, before they flower; 2) ifbolting and crosspollination occurred between event H7-1 and other Beta vegetable crops, the harvested crop would not be affected; 3) any grower of Beta vegetable crops who wanted to be certain of preventing cross pollination could do so by controlling bolters in herown vegetable crop fields; 4) a volunteer event H7-1 hybrid appearing in a subsequent crop resulting from cross pollination can be controlled using standard weed control practices and 5) major production ofsugar beet root crops and other Beta vegetable crops do notcoincide. 

### In addition, among the sugar beet production areas, organic Beta vegetable growers, who maysometimes savetheir own seed, are concentrated in California, where only conventional sugar beet is grown. The interim measuresfurther reduce the potential for geneflow from event H7-1 root crops to other Beta vegetable crops by requiring complete control ofbolters. Underthe proposed interim measures, all event H7-1 root crop growers will have measures in placethat require them to survey, identify, and eliminate any bolters in their root crop fields beforethey produce pollen or

Event H7-1 Draft ER 93 Environmental Consequences 7/28/2010set seed (Item 

### 5). Item 

### 6 ofthe interim measures requires event 

### H7-1 processors or cooperatives to survey, identify, and eliminate any bolters in outdoor storage beforethey produce pollen or set seed. Therefore, no or negligible impacts from geneflow from event 

### H7-1 sugar beet root crops to other Beta vegetable crops would be expected underAlternative 2. The prohibition on growing event 

### H7-1 in California (interim measure Item 

### 1), wherethe majority ofthe organic Beta vegetable crops in sugar beet production areas is grown, will further reduce the potential for any impact. In the multiple years ofcultivation to date ofGT sugar beet on a wide scale, there are no indicationsthat gene flow has occurred." 

### 3.6 IMPACTS OF EVENT H7-1 SUGAR BEET ROOT CROPS ON OTHER

### BETA SEED PRODUCTION AREAS As discussed in Section 2.8, nearly all red table beet and Swiss chard seed production occurs in western Washington State and in California, where event 

### H7-1 sugar beet root crops are not grown. A small amount of red table beet and Swiss chard seed production occurs in the Willamette Valley, where sugar beet root crops are not grown. Spinach beetseed production, if it exists separately from red table beet and Swiss chard production, is apparently very small. 

### 3.6.1 Impactsummary 

### Alternative 1 UnderAlternative 1, there would be no impactsfrom event 

### H7-1 production on other Beta crops. 

### Alternative2 Even withoutthe interim measures, impacts from event 

### H7-1 sugar beet root crops to seed production areas for red table beets and Swiss chard (other Beta seed crops) have not occurred andwould not be expected because: 1) sugar beets are harvested in the vegetative stage, beforetheyflower; 2) seed production for red table beets and Swiss chard does notoccur in or nearthe same geographic areas as event 

### H7-7 sugar beet root production. Even ifthe unlikely eventthere were isolated areas ofother Beta seed crops outside the main production areas (seed savers) and nearsugar beet root crops, the interim measuresfurther reduce the potential for geneflowfrom event 

### H7-1 root crops to other Beta seed crops by requiring complete control ofbolters. Underthe proposed interim measures, all event

### H7-1 root

31 Hofer Decl. (Dkt. #48) 

### If 14; Berg Dec!. (Dkt. #39) 1115; Grant Dec!. (Dkt. #45) 1118; Lehner Dec!. (Dkt. #252) 11 6. Event H7-1 Draft ER 94 Environmental Consequences 7/28/2010crop growerswill have measures in placethat require them to survey, identify, and eliminate any bolters in their root crop fields before they produce pollen orset seed (Item 5). Item 6 ofthe interim measures requires event H7-1 processors or cooperatives to survey, identify, and eliminate any bolters in outdoor storage before they produce pollen orset seed. Therefore, no or negligible impactsfrom gene flow from event H7-1 sugar beet root crops to other Beta seed crops would be expected underAlternative 

### 2. The prohibition on growing event H7-1 in California and the Western Washington counties wherethe majority ofthe US red table beet and Swiss chard seed production occurs (interim measure Item 1), will further reduce the potential for any impact. In the multiple years ofwide scale cultivation of H7-1 sugar beets, there have been no indications that that any geneflow has occurred 32 

### 3.7 IMPACTS OF EVENT H7-1 ROOT CROPS ON NATIVE BEETS As discussed in Section 2.9, no native members ofthe genus Beta arefound in North America. Therefore, gene flow to native beets will notoccur undereither alternative. The absence of native Beta plants in North American is an importantdifferencefor sugar beet production concerns (both event H7-1 and conventional) from other regions ofthe world, in particular, the EU, where "[ilt is considered essential to preservethe diversity ofsea beet [wild 

### B. vulgaris ssp. maritimalfor any long term plant breeding strategy, and for conservation and study in its own right" (Messean et ai, 2009, p. 40). 

### 3.7.1 Impactsummary Becausethere are no native beet populations in the US, therewould be no impactwith either alternative. 

### 3.8 IMPACTS OF EVENT H7-1 CROPS ON NON-NATIVE WILD AND WEEDBEETS Non-nativewild and weed beets are described in detail in Section 2.9. Exceptfor isolated reports in Michigan and Oregon, all the known populations ofnon-nativewild and weed beets in sugar beet root production states occur in California, where event 

### H7-1 sugar beets are not grown. As discussed in Section 2.9, B. macrocatpaweed beets are a weed issue in the Imperial Valley, the only major sugar beet production area in California. Even so, research in 1998found only minor introgression between the sugar beets and B. macrocarpa after 66 years ofcoexistence in the Imperial Valley (Bartsch and Ellstrand, 1999).

32 Hofer Decl.. (Ok!.. #48)

### 11 14; Berg Decl

.. (Ok!.. #39)

### 11 15; Grant Decl.. (Ok!.. #45)

### 11 18; Lehner Decl.. (Ok!.

. #252) '116. Event H7-1 Draft ER 

### 95 Environmental Consequences 7/28/2010

### 3.8.1 Impact summary 

## Alternative1 UnderAlternative 1, there would be no effect ofgeneflowfrom event H7-1 to non-nativewild or weed beets. 

## Alternative2 APHIS has previously concluded thatthere are no issueswith weed beet populations in the U.S. outside California. Within the states where event H7-1 root crops are grown, there are reports of non-native wild beets from Montana, Oregon and Michigan. The reports from Montana are dated; more recent data do not indicate the presence ofnon-native wild orweed beets in Montana. Also, the reportwas from a part of Montana where sugar beets root crops are not grown. The single reportfrom Oregon is from an area where sugar beet root crops are not grown. One ofthe Michigan reports was from a county where sugar beet crops are produced. No additional information was found, and weed beets are not reported as a weed problem in sugar beet root production in Michigan (Michigan Sugar Company, 2009). Based on the absence of any information about any uncultivated beet populations in Michigan (and the challenges in surviving winter) non-native wild orweed beet populations are expected to be nonexistent or minor. The only potential for impactfrom a sugar beet root crop would be by geneflow from an uncontrolled bolter, assuming any non-native wild orweed beet is close enough to the bolter and flowering at the same time, so that it might be pollinated. Based on this information, the potential for impactfrom sugar beet root production crops on non-native wild orweed beets appears to be negligible. It would be non-existentwith the proposed interim measures. Underthe proposed interim measures, all event H7-1 root crop growers will have measures in place that require them to survey, identify, and eliminate any bolters in their root crop fields before they produce pollen or set seed (item 

### 5). Item 

### 6 ofthe interim measures reqUires event H7-1 processors or cooperatives to survey, identify, and eliminate any bolters in outdoor storage before they produce pollen or set seed In the multiple years of H7-1 cUltivation to date, there have been no issues identified with wild orweed beets. Non-nativewild and weed beet populations exist in California. However, no event H7-1 commercial crops have been grown in California, and Item 1ofthe interim measures prohibits growing event H7-1 crops in California. Therefore, underAlternative 2, 

### no impacts to non-native wild orweed beets would be expected.

Event H7-1 Draft ER 

### 96 Environmental Consequences 7/28/2010

### 3.9 IMPACTS OF EVENT H7-1 SEED PRODUCTION ON CONVENTIONAL SUGAR BEET AND OTHER BETA SEED CROPS It is possible, without properstewardship, for cross-pollination and gene flow between crop types during seed production, because that is where pollination happens. Also, absent appropriate stewardship measures, physical mixing ofseeds is possible during harvesting, seed cleaning, packaging and transport. 3.9.1 Maintaining seed purity, identify and quality The Federal Seed Act and its implementing regulations" establish basic standards for certification ofseed, which are carried out by state seed certifying agencies. A state seed certifying agency is created by state law, has authority to certify seed, and has standards and procedures approved by USDA "to assure the genetic purity and identity ofthe seed certified." Seed certifying agencies' standards and procedures must meet orexceed those specified in the USDA regulations. 34 

### However, sugar beet seed is generally not certified, and seed companies have established their own standards, as described in Section 2. 

### There are certified wheat, soybean and corn seed growers who produce their seed to sell to farmers for planting their commercial crops. This issue is not relevant in sugar beets, because none ofthe sugar beet root growers harvest any sugar beet seed. All sugar beet seed producers sell all oftheir seed to seed companies to be sold to farmers. Even ifsugar beet root growers could save some seed, they have no means for processing it (so it would work in a planter) and providing the appropriate seed treatments and would nevertake the risk oftrying to plant it because ofthe uncertainty ofwhat they have. While sugar beet seed is generally not certified, the Oregon Seed Certification Service (OSeS) standards for certified seed and the corresponding isolation distances are reported here, as additional data points on what to expect in seed purity from a given isolation distance. The oses has set the following standards for those items for certified sugar beet seed (OSeS, 

### 1993):

• Pure seed, minimum: 

### 99.00%

• Other crops, maximum: 

### 0.10%

• Inert matter, maximum: 

### 1.00%

33 7 C.F.R. §CFR 201 34 7 U.S.C. §USC 1551(a)(25) and 7 C.F.R. §CFR 201.67 

### Event H7-1 Draft ER 97 Environmental Consequences 7/28/2010• Weed seed, maximum: 0.10% Minimum isolation distances required for certified seed are as follows (OSCS, 1993):

• From sugar beet pollen ofsimilar ploidy or between fields where male sterility is not used

- 2,600 ft (0.49 mile)

• From other pollinator or genus Beta that is not a sugar beet
- 8,000 ft (1.5 mile) The maximum specified OSCS required isolation distanceforsugar beet seed production is 10,200ft (1.9 miles, from other, non-sugar beet Beta species) for "stock" seed which has a maximum allowable concentration of"other crop" seed of0.00% (OSCS, 1993). 3.9.2 Summary of practices for sugar beetseed production All ofthe sugar beet seed in the Willamette Valley is produced by eitherWest Coast Beet Seed Company (WCBSC) or by Betaseed (see Section 2.7 ofthis ER). WCBSC has developed explicit standard operating procedures and growerguidelines that are intended to minimize and/or eliminatethe possibility ofpollen-flow between fields ofrelated Beta species (See Section 2.7 and Appendix B). Both WCBS and Betaseed belong to theWillamette Valley Specialty Seed Association (WVSSA) and followthe guidelines for isolation and minimum separation distances between fields (Appendix A). The minimum isolation distancefrom event H7-1 ("GMO") sugar beet and all other open pollinated Beta crops, in both the WCBS protocol and the WVSSA gUidelines is four miles. All growers ofcommercial specialty seed in the Willamette Valley are members ofthe WVSSA (Loberg, 2010). This includes all commercial companies raising Beta species. The isolation distances required by WVSSA between Event H7-1 sugar beets and other Beta species such as chard ortable beets is 2.1 miles furtherthan the maximum required OCCS isolation distanceforstock seed discussed above. Principles ofquality assurance for sugar beet seed production have been set forth in an industry-endorsed Code ofConduct (Appendix C). The Sugar Beet Code ofConduct adopted by the beet group ofthe International Seed Federation (ISF) describesthe measuresthe sugar beet seed industry has taken to deliver high qualityvarieties, including measuresto minimize adventitious presence oftransgenic sugar beet seed in non-transgenic Beta seed. The Code of Conduct document has been agreed on by Syngenta Seeds, SESVanderHave, Danisco Seed, Fr. Strube Saatzucht KG, A. Dieckmann-Heimburg, KWS (owns Betaseed), and affiliated companies. 3.9.3 Sugar beetseed production since 2007

Event H7-1 Draft ER 

### 98 Environmental Consequences 7/28/2010

### Commercial H7-1 sugar beet seed has been produced since 2005, with the first major seed production year in 2006. The total acreage ofH7-1 sugar beet in the Willamette Valley since 2008 has been between 4000 and 5000 acres (Gabel, 2010, p. 7; Pierson, 2010, p.10). Only one growerwho sells organic beet orchard seed has been identified in the Willamette Valley. That grower produced chard seed on approximately 1-3 acres atthe Western margin ofthe Willamette Valley. He has tested his organic chard seed using a PCR test capable ofdetecting 0.01% GE content during this period (Morton, 2010, 61:15-62:6). Thatseed has been tested each yearsince 2007 and to date has not detectedthe presence ofany H7-1 sugar beet. (Hoffman, 2010a, p. 15; Morton, 2010, 36:8-17,75:19-77:13,99:6-21,112:10-14; Stearns, 2010, 40:4-15, 49:6-16).
In May 2009, an incidentwas reported involving event H7-1 steckling disposal that raised questions regarding one sugar beet seed company's stewardship and disposal requirements for those materials (Roseboro, 2009). Stecklings are sugar beet roots that may be transplanted into hybrid sugar beet fields. In or around May 2009, the Pro Bark garden store in Corvalis, Oregon procured a quantity ofpeat moss from Betaseed. Betaseed had used the peat moss to transport a shipment ofsugar beet stecklings, and afterthe shipment had been transplanted, some quantity ofstecklings remained in the peat moss. After Pro Bark obtained the peat moss Pro Bark mixed it with potting soil and offered itforsale as afertile soil mixture. Betaseed learned thatthe mix was being sold and that it contained some stecklings, and atthat point, Pro Bark's records indicated that it had sold portions ofthe mixtureto thirty customers located in the Corvalis and Albany area. Betaseed repossessed the portion ofthe mixture that had not been sold. Betaseed personnel visited twenty ofthe thirty customers who had purchased portions of the mixture and removed any stecklings or steckling fragments found in the mixture. The owner of Pro Bark contacted seven additional purchasers and requested that they inspectfor and destroy any stecklings they had purchased (Lehner 2010, pp 7-10.)
Betaseed reported that the stecklings found in the mixture after repossessing it were not likelyto survive and produce pollen. Most ofthe stecklings were fragmented, rotting or dead. Also, because a large percentage of Betaseed hybrid sugar beetfields in the Willamette Valley in 2009 had the event H7-1 gene only on the non-pollinating female plant (see Section 2.7), the shipment ofstecklings that Betaseed had transported in the peat moss was composed ofless than 5% H7-1 male pollinators. Therefore, according to Betaseed, the chances that any steckling in the peat moss was intact, alive and a male H7-1 pollinatorwere remote. In addition, given the time ofyearwhen the fertile mixture was sold, cross-pollination would have been very Event H7-1 Draft ER 

### 99 Environmental Consequences 7/28/2010unlikely even ifthe stecklings had been ableto produce pollen, and there were no subsequent reports ofany cross-pollination from the stecklings. Betaseed subsequently revised its Standard Operating Proceduresto provide for proper disposal ofthe peat moss in which it transports stecklings (Lehner, 2010, pp. 7-10).
3.9.4 Measured sugar beet pollen dispersal Many studies have been done to measure distances overwhich cross-pollination may occur in Beta species, with a range ofresults (e.g., Bartsch et ai, 2003; Chamberlain, 1967; Darmencyet ai, 2009; Darmency et ai, 2007; Fenart etai, 2007). Darmency etal (2009) summarized a literature review ofstudies on pollen flow in sugar beet (values reported in meters converted to feet):
Authors Maximum dispersal Alibert et al (2005) 2.1% at700 ft Archimowitsch (1949) 0.3% at 2,000 ft Bateman (1947) 0.07% at 62 ft Brants et al (1992) 8% at 250 ft Dark (1971) 0.1% at 100 ft Dark (1971) 3,900 ft max (using a pollen trap, not hybrid seed production) Darmency etal (2007) 1.3% at 920 ft Jensen and Bogh (1942) 2,600 ft max (using a pollen trap, not hybrid seed production) Madsen (1994) 0.31% at 250 ft Saeglitz et al (2000) 40% at660 ft Scott and Longden (1970) 26 ft max (using a pollen trap, not hybrid seed production') Stewart and Cambell (1952) 10% at 50 ft Vigouroux etal (1999) 1.2% at 50 ft " Note. The maximum dispersal was the highest rate at the farthest distance to which pollen or hybrrds were found in the study". Darmency et al (2009, p. 1085) notethatthe experiments "were hardly comparable becausethe experimental design varied widely." The researchers also found that nearly all fertilization from pollen source occurs nearthe field (within about0.3 miles). The summary table does not make distinction between mere pollen presence and actual hybridization, which, as discussed previously, can be very different. Darmency et al 

### did not report how many, ifany, ofthese studies used isolated bait plants ratherthan groups ofreceptor plants thatwould be producing their own pollen cloud, which, as discussed above, could make a substantial difference (i.e., the percentages ofpollination by an outside source are much smallerwith competition). Also, in their own experiments, even when the pollen reached the target plant and hybridization 

### did Event H7-1 Draft ER 100 Environmental Consequences 7/28/2010

### occur, Darmency etal found a large drop in germination rates in seeds produced by plants removed from the source, with approximately 40 percent atthe source dropping to one percent ataround 1,000feetfrom the source (2009, p. 1087). 3.9.5 Modeled sugar beet pollen dispersal Research scientists specializing in modeling pollen dispersal have modeled the sugar beet pollen dispersal for outcrossing to the organic Beta 

### production field ofa Plaintiffs declarantwho believed his fields would be cross-pollinated by event H7-1. The nearest event H7-1 field was 6.9 miles distant. Using conservative assumptions and modeling conditions for the three days during the "pollen shed" period when wind conditions were most likely to result in crosspollination (June 22, 23, and 27), the modelers obtained the following results for likelihood of outcrossing: June 22,1 in 4.9 million; June 23, one in 1.1 billion; and June 27,1 in 222 million. The risk ofany successful pollination in these circumstances is highly remote.

3.9.6 Site-specific assessmentofcross-pollination potential 

### in theWillamette Valley This discussion focuses on the Willamette Valley because it is the only known location where event H7-1 commercial seed production and commercial seed production of Swiss chard and red table beet coexist. At least three qualified scientists have evaluated the potential forgene flow from event H7-1 to other Beta 

### seed crops in the Willamette Valley: Mark Westgate, PhD, whose results are summarized above; Neil Hoffman, PhD. and Leonard Panella, PhD. Westgate is a professor ofcrop production and physiology at Iowa State University, whose "scientific research focuses on understanding environmental factors that affect pollination and seed formation" (Westgate, 2010, p. 1). Hoffman is a plant physiologistwho is currently an APHIS official. Among his previous positions were professor ofplant biology at the Carnegie Institution and Stanford University (Hoffman 2010a, p. 1). Panella, a plant genetiCist, is research leader ofthe sugar beet research unit atthe USDA ARS Crop Research Laboratory in Fort Collins, Colorado (Panella, 2010, p. 1). Westgate explains that most pollen falls within the "immediately surrounding" area ofthe source field. In addition, many otherfactors affectthe possibility ofcross pollination in two Beta 

### seed production fields, including receptiveness ofthe female, wind and humidity conditions, viability ofthe pollen, and competition (see Section 2.4for a general discussion ofthese factors). For example, Swiss chard and table beets that are grown for seed are primarily open pollinated (all plants produce pollen) ratherthan hybrids using male sterile females, as is used in the production ofmost sugar beet seed (discussed in Section 2.7). The pollen cloud in an open

Event H7-1 

### Draft ER 101 Environmental Consequences 7/28/2010pollinated field is "typicallyfourtimes more densethan the local pollen cloud for a standard hybrid field" with "billions" ofpollen grains persquare meter making it much more difficultfor a small amount ofthe stray pollen that might be carried on the wind from anotherfield to compete in the open pollinated fields (Westgate, p
.. 5). Westgate concludes, in general, "when all the principal factors affecting pollination are considered, the probability ofpollination oftable beet or chard fields by sugar beet pollen in theWillamette Valley is infinitesimally small" (Westgate, 2010, p. 6). Hoffman indicates that nearly all fertilization from a pollen source (99.9%) occurs within thefirst 500 m (about 0.3 miles), and that any pollen that might reach another downwind field would have to compete with pollen from thatfield. Based on his assessment ofconditions in the Willamette Valley, Hoffman concluded thatthe 4-mile isolation distance (as articulated in Interim measure No.2) "to isolate unlike sexually compatible crops such as Swiss chard, table beets and sugar beets is morethan 12 times the distance needed to reduce cross-pollination between RRSB and Swiss chard to 0.1

### % (1 seed in 1000) in a worst case scenario without competition from a local pollen source" (Hoffman, 2010a, p. 14). Hoffman expects the level ofgeneflow to be less than one seed in 10,000 (0.01%) with a four mile isolation distance. Panella concurred with Hoffman's analysis and conclusion (Panella, 2010, p. 5). Carol Mallory-Smith, PhD, professor in the DepartmentofAgriculture at Oregon State University in the Willamette Valley, concluded thatthe "proposed restrictions [interim measure including a 4 mile isolation distance] will provide significant safeguardsto protect Beta species seed producers whilethe EIS is being conducted" and thatthe risk ofgeneflowwould be "extremely low." (Mallory-Smith, 2010, pp. 1- 2). 3.9.7 Use ofevent H7-1 trait on male-sterile female Seed production companies use a hybrid seed production system in which the event H7-1 trait is on thefemale (male sterile plants) in a large proportion ofcommercial seed production fields. In theWillamette Valley at leasttwo seed companies use this system exclusively (Anfinrud, 2010, pp. 1-2; Lehner, 2010, pp. 5-6; Meier, 2010, p. 8). Essentially zero event H7-1 pollen is produced bythese "female side" seed production fields. As a result ofthese methods, 78.6% of the currently growing GE sugar beet seed crop in the Willamette Valley is male-sterilefemale. Becausethese plants producevirtually zero pollen, they eliminate any realistic risk for unintentional spread ofthe GEtrait. 3.9.8 Red table beetofftypes

Event H7-1 Draft ER 102 Environmental Consequences 7/28/2010

### Seed companies growing sugar beets in the Willametle Valley occasionally find a very small percentage ofoff-types from red table beet crops. Seed companies have indicated a very low level ofoff-types in sugar beet crops, and one seed company reports that its latest "observation plots did not produce any off-types" (Lehner, 2010, p. 3). Customers (i.e., growers of commercial sugar beet root crops) have likewise indicated that after inspecting the millions of plants grown in variety trials conducted over several years, "the numberofchard or red beet offtypes were so small as to be, for all intents and purposes, not quantifiable." (Grant, 2010, p.6; Berg, 2010, p. 5; Hofer, 2010, p.4). Seed companies regularly perform grow outtests to determine ifthere are any issues with off-types (Lehner, 2010, p.3; Hovland, 2010, pp. 2-3). Red table beet offtypes in sugar beetfields could occur due to nearby backyard gardeners growing red table beets, or might occurfrom open pollinated red table beetfields upwind from sugar beetfields. (Anfinrud, 2010, 109:13-17). In an open pollinated field, every plant sheds pollen (Stander, 2010, p. 2). Thus an acre of open pollinated red table beets would produce far more pollen than an acre ofhybrid sugar beetfields, where the only one-fourth to one-third of the plants produce pollen (Westgate, 2010, p. 

### 5). The Willametle Valley Specialty Seed Association pinning guidelines and isolation distances require 

### 4 mile isolation distances between open pollinated red beet and sugar beetfields, in orderto limit red beet offtypes in sugar beet fields (Stander, 2010, p. 2). The potential for sugar beet gene transmission to open pollinated red beetfields is very low, because as indicated, a greatervolume of pollen per acre are shed by the open pOllinated field (Westgate, 2010, p. 

### 5) (indicating "billions" ofpollen grains per square meter shed by an open pollinated red beet field).).


### 3.9.9 Nosensitivityto event H7

### -1 by conventional sugar beet growers; Stewardship regarding mechanical mixing There is no indication ofsensitivity by customers for conventional sugar beet seed to the possibility ofan inadvertent presence ofevent H7-1 genetic material in the conventional seed (Pierson, 2010, p. 17). First, there is currently no market in the U.S. for organic sugar beets (Pierson, 2010, p. 17). Second, in most areas where both event H7-1 and conventional sugar beets are grown, both types of beets would be combined and processed together, with no effort to differentiate between sugarfrom H7-1 and conventional beets (Pierson, 2010, pp. 16-17). The sugarfrom conventional beets does not differ chemically or in any otherway from the sugar from H7-1 beets (Hoffman, 2010, p. 16).
As set forth in Section 2.7.3, each ofthe seed companies producing H7-1 seed utilizes detailed measures to address the possibility of mechanical mixing of H7-1 and conventional sugar beet
Event H7-1 

### Draft ER 103 

### Environmental Consequences 7/28/2010

### seed. These measures would be subject to audit under the interim measures to ensure that they continue to be utilized and are successful.
Because seed production for red beet and chard seed crops is completely separate from sugar beet seed production, there is virtually no risk of mechanical mixing. As discussed in Section 2.8, the two types of production employ different growers, different equipment and different facilties. Accordingly, there is no significant risk ofmixing.
3.9.10 Question ofzero tolerance We have identified one organic seed producerwho has chosen to produce organic chard seed (among several other organic crops) in the Willamette Valley. This organic producer has approximately one to three acres ofproduction on the Western margin ofthe Valley. He has indicated that hefaces a risk ofgenetictransferfrom event H7-1 seed fields, and that he sells to customers for his organiC chard with zero tolerance for any level ofoutcrossing with event H7- 1. That producer has tested his chard seeds since 2007 with a PCR genetictest and found no indications ofevent H7-1 traits in his crops. To date, he has not lost sales dueto a risk ofcross pollination from Event H7-1. He reports that the costs ofthe peRtesting for multipleyears since 2007 have totaled roughly $700, and that a positive testforevent H7-1 for his crop could negatively affectthe reputation that producer has with his customers. That seed producer has also indicated in public statements through the media that he is not concerned about a risk of cross-pollination from event H7-1 seed fields where the GE trait is on the female non-pollinator (Morton, 2009, 9: 12-19). A seed retailerwho buys from that producer has reported that he has multiple sources for chard seed outside the Willamette Valley, including in California, but continues to purchase from that producer nevertheless. In addition, both that seed producerand the seed retailer have participated in the development ofa consensus standard setting a threshold forthe presence ofGE traits in organic food products and in seed. The Non-GMO Project Working Standard, sponsored by leading players in the organic industry (including Whole Foods), specifically permits crops to be verified "nonGMO" despitethe presence ofa low level ofbiotech content-O.25% for GE sugar beet seed and other Beta 

### seed crops (Non-GMO Project, 2010, pp. 25, 34) and 0.9% in organic food and feed. Section 2.4.3 ofthe Working Standard explains that its product content standards apply to the crops listed on Appendix B, plus "close relatives ofthese crops that are subjectto cross pollination" (Non-GMO Project, 2010, p. 12). Appendix Bspecifically lists "sugar beets" as one ofthose crops "with GMO Risk" subject to the standard, and also expressly identifies "chard" Event H7-1 Draft ER 104 

### Environmental Consequences 7/28/2010

### and "table beets" as close relatives forwhich cross-pollination is possible (Non-GMO Project, 2010, p. 34). Section 2.6 explains that "[t]he Non-GMO Project has established" a 0.1% GMO content threshold for "seed and other propagation materials" for all crops listed in Appendix B, but the standards include a specific variance of0.25% for sugar beet seeds and other crops identified (Non-GMO Project, 2010, pp. 14,34). This 0.25% level is thus the Working Standard's currentthreshold for "non-GMO" sugar beet seed and other Beta 

### seed crops. Other commercial producers ofsugar beet, red beet or chard seed in the Willamette Valley have all consented to and abide by the Willamette Valley Specialty Seed Association standards, discussed in Section 2.7 and Appendix A. 

### 3.9.11 Seed availability As discussed in Section 2.7, sugar beet variety development is competitive, technological, and expensive multi-year activity. Seed companies develop varieties with traits they expect growers to want, and the sugar beet companies seed selection committees chose the varieties they wish to grow. It is a market-driven process, where the grower cooperatives themselves determine what is available for planting. Every year, each sugar beet company has a number ofvarieties that growers may choose from. As the popularity ofevent H7-1 sugar beet among growers has grown, there have been fewer available conventional varieties and more event H7-1 varieties; however, conventional varieties have been available. There is no organic sugar beet seed production in the sugar beet seed production areas. Conventional and/or organic sugar beet seeds are availablefrom some US seed suppliers (conventional), and from European seed companies (conventional and organic). (SESVaderHave, 2010; Millington Seed Company, 2010). KWS has some 250 varieties of sugar beet seeds available, including organic (KWS, Grain, 2008). Organic sugar beet is a noteworthy crop in the EU (Eurostat, 2010). Not all organic beets are processed into sugar; some are used to produce a syrup that is integrated into organic food preparations (Ceddia and Cerezo, 2008). 

### 3.9.12 Impact Summary 

## Alternative1 UnderAlternative 1, there would be no gene flow impacts to growers oforganic or conventional Beta 

### seed from the production ofevent H7-1 sugar beet seed. 

## Alternative2
Event 

### H7-1 Draft ER 

### 105 Environmental Consequences 

### 7/28/2010UnderAlternative 2, no or negligible impacts from event H7-1 seed production on growers of organic or conventional Beta seed are expected for the following reasons:

• The large majority ofred beet and chard seed crops are grown in differentgeographic areas than are Event H7-1 sugarbeets.
• Even in theWillamelte Valley (where mostsugarbeetseed crops and a limited acreage ofother beta species seed crops are grown), there have been no reported impacts since H7-1 commercial seed production began in 2006, and with the proposed interim measures, the potential for impacts would be further reduced.
• Based on 1) the use in the majority ofthe event H7-1 seed production ofthe trait on the male-sterilefemale; 2) results ofsugar beet pollination outcrossing data in the published scientific literature; 

### 3) site-specific modeling; 4) the relationship between expected seed purity levels and isolation distances determined by the OSCS; 5) the results of experience and testing in the WillamelteValley seed production area since 2007 and, 6) the analysis and conclusions ofqualified scientistswho specifically addressed this issue, the 4-mile isolation distance (Interim measure Item 2) is expected to result in eliminating any significant riskthat cross-pollination oforganic or conventional red beet or chard crops will occur, and if it happens, makethe rate ofoutcrossing very low if not undetectable --likely at rates of less than 1 in 10,000 (less than one seed in 10,000with the event H7-1 trait). This is, forexample, far less than the non-GMO Project proposed tolerance levelsfor sugar beet and other Beta seed (0.25%) (Non-GMO Project, 2010),
• The use of hybridswith the event H7-1 trait on the female, in combination with the disclosure requirements regarding malefertile event H7-1 seed crops (Interim measure Item 3) will drastically reduce the potentialfor cross-pollination. Forthe large majority of H7-1 seed fields (with the trait on thefemale), there is essentially zero risk of crossing with a red beet or chard seed crop. Forthosefields with the H7-1 gene on the male pollinator, the isolation distanceswill reduce any risk significantly, and producers of red beet and chard can ascertain whatthose distances are and take appropriate measures (to position theirfields, scoutfor off-types, conduct genetictesting, orthrough other means discussed herein) ifthey are concerned about any level ofrisk.
• The interim measureto prevent seed mixing (Interim measure Item 4), which makes current seed and steckling production and handling practices mandatory (described in Section 2), will make the potentially low level presence ofevent H7-1 in conventional sugar beet seed negligible and will eliminate adventitious presence ofevent H7-1 in other Beta seeds. Conventional sugar beet seed will continueto be available as long as growers continueto choose it in the variety trials. Growers who purchase seed purchase a specific variety, which is labeled as such. In addition, in the event unwanted transmission of H7-1 traits to a red beet or chard crop did occur, there are multiple means for a seed producerto address it. First, because a seed producer of red beetor chard growing beta speciestypically will inspecteach plant remove any off-types from his production fields, any preexisting unwanted cross between a sugar beet and red beet or chard plant can be addressed before seed is produced with an unwanted trait

Event H7-1 Draft ER 106 Environmental Consequences 7/28/2010

### (Stander, 2010, pp. 3 - 4). Second, once seed is produced, a growertypically will perform growout tests on a sample ofthe seed to confirm thatthe seed is producing plants without undesired off-types. This can also identify any issues. Third, multipletypes ofgenetictesting can be conducted to confirm the lack ofany H7-1 trait (Hovland, 2010, pp. 2 - 3). While PCR testing is available with a very high level ofsensitivity (to 0.01 %), 

### inexpensive genetic strip tests capable of identifying H7-1 are also availablefor $2 to $4 pertest, with a sensitivity ofapproximately 0.1 % 

### (Stander, 2010, pp. 4 - 5). Such testing may be utilized in a mannerthat employs samples from multiple seed plants and reduces the number oftests required per field. In the event ofa positive test, the seed producer may use additional testing to isolate the source ofthe portion of his field producing that result (Id). 

### Further, retailers ofseed with sensitivity to H7-1 content may also conduct grow out tests, or utilize the same genetictesting methods to address any concerns they may have (Id) 

### As discussed in Section 3.17, in light ofthe above factors, the socioeconomic impacts on farmers growing red table beet and Swiss chard seed are negligible. 3.10 

### LIVESTOCK PRODUCTION SYSTEMS The only impactsto livestock production systems would be related to animal feed, which is discussed in Section 3.11. 

### 3.11 FOOD AND FEED Both food (sugar and molasses derivatives) and animal feed (molasses and beet pulp) are derived from sugar beets. In this section we summarize the large body ofscientific evidence that has been developed that supports the conclusion that food and feed derived from event H7- 1sugar beets are as safe and healthy as food and feed derived from conventional sugar beets. While the evidence has largely been developed by Monsanto and/or KWS and the contract research organizations supported by Monsanto and/or KWS, it has been evaluated and peer reviewed by panels ofgovernmentscientists from the US, Canada, the European Union (EU), Japan, Australia, New Zealand, Mexico, South Korea, the Russian Federation, China, Singapore, Colombia and the Philippines, all ofwhom have approved, or recommended for approval, the use ofproducts from event H7-1 in their countries (FSANZ, 2005; Monsanto/KWS 2007; Berg 2010). We begin with a summary ofFDA's authority and policy underthe federal Food, Drug and CosmeticAct (FFDCA) with regard to ensuring the safety offood and feed derived from new plant varieties developed using rONA methods. Wethen document each element FDA
Event H7-1 Draft ER 107 Environmental Consequences 7/28/2010evaluated in its consultation process. Then wesummarize the evaluations and conclusions of several other international scientific oversight groups. 3.11.1 FDA authority and policy FDA policy statement. In 1992, the FDA issued a policy statement clarifying its interpretation ofthe FFDCA, regarding foods (including animal feed) derived from new plantvarieties, including plants developed by the newer methods ofgenetic modification, including rONA. The purpose ofthe policy is "to ensurethat relevant scientific, safety, and regulatory issues are resolved priorto the introduction ofsuch products into the marketplace" (FDA, 1992). FDA is the "primaryfederal agency responsible for ensuring the safety ofcommercial food and food additives, except meatand poultry products" and "FDA has ample authority underthe act's [FFDCA] safety provisions to regulate and ensurethe safety offoods derived from new plant varieties, including plants developed by newtechniques. This includes authorityto require, where necessary, a premarket safety review by FDA priorto marketing ofthe food" (FDA, 1992). Undersection 402(a)(1) ofthe FFDCA, a food is adulterated and thus unlawful "if it bears or contains an added poisonous ordeleterious sUbstance that may renderthe food injurious to health or a naturally occurring substancethat is ordinarily injurious" (FDA, 1992). FDA has the authorityto ensure safety of newfoods. FDA considers its existing statutory authority underthe FFDCA and its implementing regulations "to befully adequate to ensurethe safety of newfood ingredients and foods derived from newvarieties ofplants, regardless ofthe process by which such foods and ingredients are produced" (FDA, 1992). "The existing tools providethis assurance because they impose a clear legal duty on producers to assure the safety offoods they offerto consumers; this legal duty is backed up by strong enforcement powers; and FDA has authorityto require premarket review and approval in cases where such review is required to protect public health" (FDA, 1992). Developers have the responsibility to evaluate the safety of new foods. "It is the responsibility of the producer of a new food to evaluate the safety ofthe food and assure that the safety requirement of section 402(a)(1) of the act is met. FDA provides gUidance to the industry regarding prudent, scientific approaches to evaluating the safety offoods derived from new plant varieties, including the safety of the added substances that are subject to section 402(a)(1) of the act. FDA encourages informal consultation between producers and FDA scientists to ensurethat safety concerns are resolved" (FDA, 1992).

Event H7-1 Draft ER 108 Environmental Consequences 7/28/2010

### Foods developed by new methods do not present greatersafety concerns. "FDA believes that the new techniques are extensions at the molecular level oftraditional methods and will be used to achieve the same goals as pursued with traditional plant breeding. The agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding" (FDA, 1992). FDA's goal is to ensurethe safety ofall food and feed. "The goal ofthe FDA's evaluation of information on new plant varieties provided by developers during the consultation process is to ensure that human food and animal feed safety issues or other regulatory issues (e.g. labeling) are resolved priorto commercial distribution" (FDA, 1997). 3.11.2 FDA biotechnology consultation notetothefile BNF 000090 FDA makesthe contents ofits biotechnology notification files (BNFs) available on the internet (see reference FDA, 2004; event H7-1 is BNF 000090)35. FDA documented its conSUltation with Monsanto/KWS on event H7-1 in a note to the file dated August 7, 2004 (Bonette, 2004). That information is summarized below. 

## Characterization, inheritance, andstability o/theintroducedDNA Using standard analytical techniques, Monsanto/KWS verified that event H7-1 contained a single copy ofthe EPSPS cassette, and that all components were intact (Bonnette, 2004; Schneider, 2003, p. 43). Monsanto/KWS conducted crosses using conventional breeding techniques resulting in 27 breeding experiments overfour generations. These studies indicate that the introduced trait (glyphosate tolerance) was stably inherited as adominanttrait (Bonette, 2004; Schneider, 2003, p.44). Using standard analytical techniques, Monsanto/KWS demonstrated the stable integration ofthe T-DNA overthree generations (Bonette, 2004; Schneider, 2003, p. 47). 

## Introducedsubstance

- CP4EPSPSenzyme As discussed in Section 3.1.1, EPSPS is a catalystfor a reaction necessary for the production ofcertain aromatic amino acids essential for plant growth and has a similarfunction in bacteria

35 http://www.accessdata.fda.gov/scripts/fcn/fcnDetaiiNavigation.cfm?rpt=bioListing&id=

### 19 Event 

### H7-1 Draft ER 

### 109 Environmental Consequences 7/28/2010

### and fungi (for example, baker's yeast). While EPSPS is present in plants, bacteria and fungi, it is not present in animals; animals do not make their own aromatic amino acids, but rather obtain them from thefoods they consume. Thus, EPSPS is normally present in food and feeds derived from plant and microbial sources (Harrison et ai, 1996). There arevariations in the genetic makeup (amino acid sequences) of EPSPS among different plants and bacteria. The EPSPS from Agrobacterium 

### sp. strain CP4 isjustone variant ofEPSPS. A unique characteristic ofthe CP4 EPSPS is that, unlike EPSPS enzymes commonly found in plants, it retains its catalytic activity in the presence ofglyphosate (Bonnette, 2004; Schneider, 2003, pp 50-51; Padgette et ai, 1995). Concentrations in sugar beet. In 1999, field trials were conducted atsix distinctfield locations distributed across Europe inthe major sugarbeet production areas. The event H7-1 sugar beets were treated with a Roundup agricultural herbicide. Samples ofbrei (roottissue processed using standard sugar beet industry methods) and top (leaf) tissues were collected and analyzed for levels ofthe CP4 EPSPS protein. On average, concentrations ofthe CP4 EPSPS protein, on a fresh weight basis, were similar in the leaftissue (161 [1g/g) 

### and in the root tissue (181 [1g/g). 

### The range ofmean levels ofthe CP4 EPSPS protein in top (leaf) tissue was 112 to 201 [1g/g 

### and in root (brei) were 145 to 202 [1g/g 

### across the sites (Schneider, 2003).

Toxicity ofCP4 EPSPS. 

### Studies were conducted on mice, using CP4 EPSPS doses of400, 100 and 40 milligrams (mg) of CP4 EPSPS per kilogram ofbody weight per day (mg/kg 

### body

### wt -d). For atypical 0.03-kg mouse, the 400 mglkg 

### body wtld dose equated to 12 mg CP4 EPSPS per mouse per day. The study was designed to reflect a 1,ODD-fold factor ofsafety on the highest possible human exposure to CP4-EPSPS, based on assumed exposuresto soybean, potato, tomato and corn at the time the study was done (Harrison et ai, 1996)36. The daily CP4 EPSPS content in the maximum mouse exposure was equivalentto the amount in approximately 160 pounds ofH7-1 sugar beets. No treatment-related adverse effects were observed, and there were no significant difference in any measured endpoints between the CP4 EPSPS treated mice and the control group (Harrison, et ai, 1996, p. 735). Monsanto/KWS also compared the amino acid sequence ofCP4 EPSPS to protein sequences in the public domain ALLPEPTIDES database using the FASTA algorithm, and reported no biologically relevant sequence similarities between CP4 EPSPS protein and known protein

36 Note that this was a theoretical exercise as no glyphosate tolerant potatoes or tomatoes are commercially grown. 

### Event H7-1 Draft 

### ER 110 Environmental Consequences 7/28/2010

### toxins were observed (Bonnette, 2004). A peptide is a molecule consisting ofseveral linked amino acids (GMO Safety, 201Oa). Allergenicity. Allergens can be derived from many sources: in animal hair, pollen, insect bites, dust mites, plants, pharmaceuticals, and food. Approximately 20,000 allergens have been identified. Most allergens in food are high molecularweight proteins and are rather resistantto gastric acid and digestive enzymes (GMO Safety, 201Oa). Monsanto/KWS searched a comprehensive database ofallergens (Hileman etai, 2002) containing sequences of known allergens, for amino acid homologyto the CP4-EPSPS protein, and concluded that there was no immunologically significant amino acid sequence homology between the CP4 EPSPS protein and amino acid sequences ofallergens in the database (Bonnette, 2004). Monsanto/KWS discussed two studies relevant to the mammalian digestibility ofCP4 EPSPS. In the first study, the CP4 EPSPS protein was exposed to simulated gastric (stomach) and intestinal fluids thatwere prepared according to the US Pharmacopoeia (1990). The half-life of the CP4 EPSPS protein was reported to be less than 15 seconds in the gastricfluid, greatly minimizing any potential forthe protein to be absorbed in the intestine. The half-lifewas less than ten minutes in the simulated intestinalfluid (Harrison etai, 1996, p 738). The second study reported similar results (Bonnette, 2004). 

## Foodandjeedllsesojsllgarbeet The main food use ofsugar beet is forthe extraction ofsucrose from sugar beet roots through a process involving hotwater extraction, followed by purification, evaporation, and centrifuge separation ofsucrose crystals (granular sugar). Refined sucrose does not contain protein or other genetic material. This process also yields sugar beet molasses and sugar beet pulp, which are often pelleted and used in animal feed. The leafy sugar beet "tops" are usually left in the field, butthey may occasionally be fed to ruminant animals (Bonnette, 2004). 

## Compositionalanalysis To assess whether sugar beet event H7-1 is as safe and nutritious as conventional sugar beet varieties, Monsanto/KWS compared the composition ofthe hybrid lines containing event H7-1, produced through conventional breeding, to the composition ofthe corresponding nontransgenic, control. Tops (leaves) and brei (processed roots) were analyzed using standard methods or other suitable methods (Bonnette, 2004).
Event H7-1 Draft ER 

### 111 Environmental Consequences 7/28/2010These analyses included proximatevalues (crude ash, crude fiber, crude fat, crude protein and dry matter), carbohydrates, quality parameters, saponins (naturally-occurring antinutrients that have a bittertaste and can act as a deterrentto foraging), and eighteen amino acids. Quality parameters measured in root samples included percent sucrose, invert sugar, sodium, potassium and alpha-amino nitrogen. All analyses were conducted as a single analysis forthe root (brei) and top (leaf) samples collected as three replica samples from each offive field trials sited. Fifty-five statistical comparisons were made with the control line, ofwhich seven were found to be statistically different (p<0.05). Based on the statistical methods, three ofthese seven would have been expected based on chance. In all seven cases, the ranges forthe statistically different components in event H7-1 significantly overlapped orfell completelywithin the range ofvalues observed forthe control, the conventional reference varieties and for available published values from conventional sugar beetvarieties (Schneider, 2003, Section C). 

### COl/clusion Based on the data submitted, the FDA considered the consultation process to be complete, and acknowledged this in a noteto the file and a letterto Monsanto (Bonnette, 2004; Tarantino, 2004).

3.11.3 Health Canada approval 2005 Health Canada's Food Directorate has legislated responsibility for premarket assessment of "novelfoods." Under Canadian regulations, sugar derived from event H7-1 sugar beet is a novel food because it is derived from a plantthat has been genetically modified to exhibit characteristics thatwere not previously observed in the plant (Health Canada, 2005). Health Canada "conducted a comprehensive assessment ofthis sugar beet according to its Guidelines forthe SafetyAssessmentofNovelFoods," reviewing the same information Monsanto/KWS provided to FDA in its consultation, and madethe following conclusion (Health Canada, 2005: 

### Health Canada's reviewofthe information presented in supportofthe food use ofsugar from glyphosate tolerant sugar beet lines containing event H7-1 concluded thatthe food use ofsugarfrom sugarbeet lines containing this eventdoes not raise concerns related to safety. Health Canada is ofthe opinion that sugarfrom sugarbeet lines containing event H7-1is as safe and nutritious as sugarfrom current commercial sugarbeetvarieties.

3.11.4 Canadian Food InspectionAgency (CFIA) approval 2005
Event H7-1 Draft ER 112 Environmental Consequences 7/28/2010The CFIA evaluated event H7-1 both as a crop to be potentially grown in Canada, and as livestockfeed, and approved both uses in 2005. Based its evaluation ofdata provided by Monsanto/KWS, and as summarized in its Decision Document 002005-54, the CFIA "determined thatthis plantwith a novel trait (PNT) and novel feed does not present altered environmental risk nordoes it present livestockfeed safety concerns when compared to currently commercialized sugar beetvarieties in Canada" (CFIA, 2005). 3.11.5 EFSA risk assessmentand EC authorization The European Food SafetyAuthority (EFSA) is an independent European agency funded by the EU budgetforthe purpose ofassessing risks associated with the food chain. Risk assessment is a specialized field ofapplied science that involves reviewing scientific data and studiesto evaluate risks associated with certain hazards (EFSA 2010). EFSA conducts risk assessment, but does not have authority to authorize use. The European Commission (EC), which is the executive body ofthe EU, determineswhether or not a genetically modified item will be authorized for use in the EU. Scope and process. The scope ofthe Monsanto/KWS application tothe EFSAwasforfood and feed, and not as a crop intended for cultivation in the EU (EFSA, 2006, p. 1). The EFSA used the same data Monsanto/KWS provided to the FDA, Health Canada, and the CFIA, and also requested additional information. The Scientific Panel on Genetically Modified Organisms (GMO Panel) developed an opinion thatwasthen adopted by the EFSA. Subsequently, in 2007, the EC authorized "the placing on the market offood and feed produced from genetically modified sugar beet H7-1" (EC, 2007). During the EFSA risk assessment process, Member states comment on the draftdecisions and can requestfurther analysis; the GMO Panel also can request additional information from the applicant. Detectable presence ofCP4 EPSPS. The GMO Panel reported that ifthe CP4 EPSPS protein was present in the sugar, which was unlikely, itwas belowthe detection limit of0.004 parts per million (ppm). No DNAwas detected in the sugar and the molasses is also "free from DNA and protein (limit ofdetection 0.002 ppm)." The CP4 EPSPS protein is present in pulp at levels around 500 ppm on a dryweight basis (EFSA, 2006, p. 9). Safety ofthe CP4 EPSPS protein. The GMO Panel noted the "long history ofdietary exposure to EPSPS proteins" for humans and animalsthe fact that "previous applications for glyphosate tolerant crops containing the CP4 EPSPS protein have been evaluated and found to be safefor human andloranimal consumption in previous [EFSA] opinions." The GMO Panel concluded that "a toxicological assessment of new constituents is notapplicable" (EFSA, 2006, 

### P 10).
Event H7-1 Draft ER 113 Environmental Consequences 7/28/2010

### Additional toxicitystudy. In response to EFSA information requests, Monsanto/KWs conducted a gO-day toxicity study, feeding processed pulp to rats, which did not indicate any adverse effects. The GMO Panel reported additional studies ofsugar beet pulp to sheep, also with no adverse effects (EFSA, 2006)37. Allergenicity. In addition to evaluating the potential allergenicity ofthe CP4 EPSPS protein, the GMO Panel considered whetherthe insertion ofthe transgene could result in modifications ofthe pattern ofexpression ofother potentially allergenic proteins within the sugar beet plant. The Panel did not considerthe issue to be relevant, as sugar beet is not a major allergenic food, and overexpression ofan existing protein "would be unlikely to alterthe overall allergenicity of the whole plant (EFSA, 2006, p. 12).38 No need for post-marketmonitoring. The GMO Panel noted "No risks to human and animal health were identified in studies ofthe CP4 EPSPS protein expressed in sugar beet H7-1, and in studies ofthe genetically modified sugar beet itself. Thus, foods and feeds produced from sugar beet H7-1 is as safe and nutritious as foods and feeds derived from conventional sugar beets." The Panel recommended no post-market monitoring (EFSA, 2006, p. 13). Conclusions. The GMO Panel stated the following in its conclusions (EFSA, 2006, p. 13):

• Sugar and molasses have been shown to be free from DNA and protein

• Animals fed with pulpwill be exposed to the CP4 EPSPS protein

• The CP4 EPSPS protein has been evaluated and found to be safe for human and/or animal consumption
• The molecular characterization and the comparative compositional analysis did not indicatethe occurrence ofany unintended effects due to the genetic modification
• Products from sugar beet H7-1 are safe as food and feed

• The nutritional value ofthe sugar beet H7-1 and the derived sugar beet products is comparableto that ofthe analogous products from conventional sugar beet • The risk ofallergenicity is ofno concern with this product 

### 3.11.6 Otherapprovals Japan approved the use ofevent H7-1 in feed 2003, in food in 2005, and the environmental in 2007 (Sato, 2008). Studies by the Japanese National Food Research Institute have confirmed that there is no detectable DNA in sugar from sugar beets, with the conclusions that "sugar beet

37 http://jas.fass.orqlcqilcontenUfuIl183121400 38 http://jas.fass.orqlcgilcontenUfull183/21400 Event H7-1 Draft 

### ER 114 Environmental Consequences 712812010

### DNA was degraded atan early stage ofsugar processing" (Oguchi et ai, 2009). Event H7-1 has also been approved for food and feed use in Mexico, South Korea, Australia, NewZealand, China, Colombia, the Russian Federation, Singapore and the Philippines (FSANZ, 2005; Monsanto/KWS 2007; Berg 2010). 3.11.7 Willingness ofthe buyerto acceptsugarfrom event H7-1 Market concerns about willingness ofbuyers to accept sugar, molasses, and/or pulp derived from event H7-1 have not resulted in any perceptible change in the demand for US-produced beet sugar or otherfractions. Based on the regulatory approvals obtained in domesticand international markets, sugar, molasses, and pulp derived from event H7-1 is being successfully marketed. As summarized above, there is a large body ofscientific evidence that has been reviewed and validated by several international scientific panels that supports the safety ofthe sugar and otherfractions derived from event H7-1 forfood and feed use. Ifthere are consumers who do notwish to purchase sugar made from event H7-1 for reasons otherthan safety and health, they have the option ofbuying sugar made from sugarcane, which is not currently produced using lines thatwere developed using modern biotechnology. However, the majority offood products containing beet sugar, such as cakes, candy, ice cream and other sweets, are likely to contain sugar derived from sugar beetvarieties containing event H7-1. Most commercial food and beverage products are also likely to contain corn or soy products derived from biotech crops (Goldsbrough, 2000). 3.11.8 Impacts Based on the scientific evidence summarized in this section, impacts on food and feed are not expected with either alternative. Food and feed derived from event H7-1 is equivalentto food and feed derivedfrom conventional sugar beets. Because both conventional and event H7-1 sugar beets are processed in the same facilities, there is no distinction in the US between food and feed derivedfrom conventional and event H7-1 sugar beets. Markets are available for all the food and feed produced. Because there is no commercial organic sugar beet industry in the US, organic sugar beet production is not impacted in anyway. Aside from sugar, the other products from sugar beets (molasses and pulp) are not major consumer items and can easily be avoided by consumers who do notwish to be exposed to GE products. As discussed above, there is no detectable DNA in processed sugar; however, consumers who wish to avoid all products derived from GE crops can purchase cane sugar ratherthan beet sugar. While processed foods, the situation is similarto thatfor corn and soy Event H7-1 Draft ER 115 Environmental Consequences 7/28/2010

### products: even without event H7-1, itwould be very difficultfor a consumer to avoid products derived from 

### GE crops. 3.12 

### WEED CONTROLAND GL YPHOSATE RESISTANCE As indicted in Section 1, EPA is responsible for regulation ofglyphosate and thus for issues of weed resistance to glyphosate (EPA, 2003)

.. This report nevertheless analyzes those issues. APHIS's 2005 EA did so as well, and the court did notfind a deficiency in that analysis. APHIS has performed other herbicide resistance analyses in many E As conducted as part of the petition review process (see http://www.aphis.usda.gov/biotechnology/not_reg.html). 3.12.1 Herbicide-resistantweeds As explained in Section 2.5, not all weed species respond the same to every herbicide mode of action. Instead, a weed species can have a natural resistance to a particular mode of action, and if a grower employs only that mode of action, over time, the naturally resistant species will overtake other weed species in that area. This is often referred to as a shift in the weed population. It is forthis reason that growers may need to use multiple products to control the full spectrum ofweeds in afield. Sugar beet weed management, including major weeds in sugar beets, herbicides used, herbicide mode of action and herbicide resistance, was discussed in Section 2.4. Table 3-1 summarizes the major sugar beet weeds in terms of resistance to herbicide groups used in sugar beets for the states where sugar beets are grown commercially. A weed is listed for a state when herbicide resistance has been confirmed. Thetable does not show the extent ofthe weeds with the noted resistance; this would vary widely. References for the table are included atthe bottom ofthe table. As of June 27, 2010, 194 herbicide-resistant weed species (341 herbicide resistant weed biotypes) have been documented worldwide (Heap, 2010). These species have been reported to be resistant to 19 different herbicide modes ofaction (Heap, 2010). Approximately five



### Table 3-1 

### Majorsugar beetweeds with resistance to herbicides groups used in sugar beets1 

### California Species I. Echinochloacrus-galli 2. Echil1ochloa crus-galli



### Event H7-1 Draft ER 

### CommonName Bamyardgrass Bamyardgrass 

### Year' 1000 2000



### 116 

### Herbicide Mode ofAction ACCase inhibitor fatty acid synthesis inhibitor.



### Environmental Consequences 7/28/2010

### Colorado SRecies 1. Aramanthusretroflexus 2. Kochiascoparia 3. Kochiascoparia 4. Avena/alllG


### IdahoSRecies

1. Kochiascopal'ia 2. Avena/a/lIG 3. Avenafatua 4. Kochiascoparia 5. AramantusretrofleXlls 

### Michigan SRecies 1. Chenopodiumalbum 2. Amaral1thllstubercula/us 3. Amaranthuspowe/lis 4. Amaranthuspowel/is 5. Amarantl1llsretroflexlIs 6. Chenopodium a/bl{111 7. Al11arclI1thushybridlls 8. Abutilol7theophrasti 9. Solanumptycanthul1l 10. Sola17l111lptycanthul1l 11. Kochiascoparia 12. Setaria/aberi



### Minnesota SRecies I. Chenopodium album 2. Abutilon Iheop!Jrasli 3. Amal'anthusretroflexlis 4. Avena/alua 5. Amaranthus tuburculatus 6. Ambrosiatrifida 7. Kochiascoparia 8. Xallthium strllll1arilll1l 7. Setaria/aberi 9. Setaria viridis 10. SetariaIlltescens 11. Ambrosia trifida 12. Amal'al1thus tuberclI/atlls

Event H7-1 Draft ER CommonName Year2 Redroot pigweed 1982 Kochia 1982 Kochia 1989 Wild Oat 1997

CommonName Year2 Kochia 1989 Wild Oat 1992 Wild Oat 1993 Kochia 1997 Redroot pigweed 2005

CommonName Year2 Larnbsquarters 1975 Tall waterhemp 2000 Powell Amaranth 2001 PO\""elI Amaranth 2001 RedrootPigweed 2001 Lambsquarters 2001 Smooth Pigweed 2002 Velvetleaf 2004 East. Blacknightshade 2004 East. Blacknightshade 2004 Kochia 2005 GiantFoxtail 2006

CommonName Year" Lambsquarters 1982 Velvetleaf 1991 Redroot Pigweed 1991 Wild Oat 1991 Tall Waterhemp 2007 Giantragweed 2006 Kochia 1994 Common cocklebur 1994 GiantFoxtail 1996 Robust WhiteFoxtail 1996 (var. robusta·alba Schreiber) YellowFoxtail 1997 Giantragweed Tall waterhemp 2006 2007

117 Herbicide Mode ofAction photosystems II inhibitors photosystems II inhibitors ALS inhibitors ACCase inhibitors

Herbicide Mode ofAction ALS inhibitors ACCase inhibitors fatty acid synthesis inhibitor. synthetic auxins photosysterns II inhibitors

Herbicide Mode ofAction photosystems II inhibitors. ALS inhibitors photosystem II inhibitors ureas and amides photosystems II inhibitors. ALS inhibitors ALS inhibitors photosystems II inhibitors photosystems II inhibitors photosystems II inhibitors. ALS inhibitors ALS inhibitors

Herbicide Mode ofAction photosystems IIinhibitors. (PI) PI PI ACCase inhibitors glycine.ALS. PI glycine. ALS inhibitors. PI ALS inhibitors ALS inhibitors ALS inhibitors ALS inhibitors ALS inhibitors glycines glycines

Environmental Consequences 7/28/2010

### Montana SQecies 1. Kochiascoparia 2. Kochiascoparia 3. Avena/alaG 4. AvenafatuG 5. Kochiascoparia 6. Avena/alau 7. Avena/alllG 

### Nebraska SQecies 1. AmaranthusIlfberculalus


### North Dakota SQecies 1. Kochiascoparia 2. Setariaviridis 3. Avena/allio 4. Kochiascoparia 5. Avenafatua 6. Kochtascoparia 7. Amarantl11lsretrojlexIIs 8. Solanumplycunlhllm 

### Oregon SQecies 1. Avena/alua 2. Avena/ailla 3. Kochiascoparia 4. Amaranthusretroflexus


### Washington SQecies 1. Kochiascoparia 2. Avena /alZia 3. Amaranthlfspolt'ellis 4. Sonchus ajper 

### Wyoming SQecies 1. Kochiascoparia 2. Kochiascoparia
Legend: 

### CommonName Kochia Kochia Wild Oat Wild Oat Kochia WildOat Wild Oat


### CommonName Tall waterhemp



### CommonName Kochia GreenFoxtail Wild Oat Kochia Wild Oat Kochia RedrootPigweed Eastern Blk.Nightshade



### CommonName Wild Oat Wild Oat Kochia Redroot Pigweed



### CommonName Kochia Wild Oat Powell Amaranth Spiny Sowthistle



### CommonName Kochia Kochia 

### Year2 1984 1989 1990 1990 1995 1996 2002


### Year2 1996



### Year2 1987 1989 1991 1995 1996 1998 1999 1999



### Year2 1190 1990 1993 1994



### Year2 1989 1991 1992 2000

1984 1996 

### HerbicideMode ofAction photosystems II inhibitors ALS inhibitors fatty acid synthesis inhibitor. ACCase inhibitors synthetic auxins ALS inhibitors ACCase inhibitors


### Herbicide Mode ofAction photosystem II inhibitors



### Herbicide Mode ofAction ALS inhibitors mitois inhibitors ACCase inhibitors synthetic auxins ALS inhibitors photosystems II inhibitors ALS inhibitors ALS inhibitors



### Herbicide Mode ofAction ACCase inhibitors mitosis inhibitors ALS inhibitors photosystems Ifinhibitors.



### Herbicide Mode ofAction ALS inhibitors ACCase inhibitors photosystem II inhibitors ALS inhibitors



### HerbicideMode ofAction photosystems 11 inhibitors ALS inhibitors

Source: Heap, I. The International Survey ofHerbicide-resistant Weeds. Online. Internet. Accessed on June 21,2010 at: wVI/w.weedscience.com.
Event H7-1 Draft ER 118 Environmental Consequences 7/28/20102 Yearresistance was ftrst reported. 

### percent of resistant species have resistance to EPSPS inhibitors (glycines, which include glyphosate). Referto Figure 2-3 forthe distribution by herbicide mode ofaction. Measuresto reduce the development of herbicide resistance are discussed in Section 2.5. 3.12.2 

### Glyphosate-resistantweeds As discussed in Section 2.5, herbicide resistance is not a unique or new phenomenon. The development ofweeds resistant to a particular herbicide mode ofaction is an issuethat growers have faced for decades. As with other herbicide modes of action, not all weeds respond the same to glyphosate, and some species naturallyvary in theirtolerance to the herbicide. Because ofthe nature ofglyphosate and its high degree ofspecificity, generally speaking, there is a reduced potential that there will be a selection forweed resistance. Glyphosate is a nonselective, foliar-applied, broad spectrum, post-emergent herbicide compared to many other herbicide groups. It operates by binding to a specific enzyme in plants thereby interfering with the plant's required metabolic process. Glyphosate is the only herbicide that binds with this enzyme, and therefore it is highly specific (Cole, 201Oa, p5). Currently in the U.S., there are two known mechanisms ofglyphosate resistance. The first is the exclusion mechanism in which glyphosate is either prevented from moving to growing cells orfrom reaching the target protein. Mechanismsthat conferthis form of resistance are relatively rare and are not common across plant species. The second mechanism, gene amplification, results from an increase in enzyme gene copies in the plantwhich leadsto higher levels of resistance to glyphosate (Cole, 201Oa, p.5). Accordingly, while glyphosate has been used extensively for overthree decades, there have been relatively few cases ofresistance development, as compared to many other herbicides and when considering the substantial glyphosate-treated acreage worldwide (approximately 1 billion acres) and the total number ofweeds that the herbicide can control. In the U.S., there are ten weed species where glyphosate-resistant biotypes are known to exist in certain areas of the country (19 weeds have been reported to have developed glyphosate resistance at some location worldwide). These resistantweeds represent a relatively small minority ofthe overall weed population. For example, in 2009, approximately 135 million ofthe 173 acres ofcorn, soybeans and cotton in the U.S. were planted with a herbicide tolerant variety, with the most common tolerance trait being glyphosatetolerance (USDA NASS, 2009a). Atthe sametime, only about 6% ofthe total planted corn, soybean and cotton acres in the U.S. are estimated to
Event H7-1 Draft ER 119 Environmental Consequences 7/28/2010have some level ofpresence ofweeds resistant to glyphosate (Ian Heap as reported byWSSA, 2010). A weed scientist from the University ofWyoming who specializes in sugar beetweed control, hastestified that in the coming years, "it is highly unlikelythat the use ofglyphosate in connection with GR [glyphosate resistant] sugar beetwill result in the same conditionsthat have led to GR weeds in otherGR crops" (Kniss, 2010, p. 3). This is in part because ofthe fundamentally different growing practices with sugar beet. Kniss reports that more diverse cropping systems (with more rotations and herbicide modes ofaction), such as those used with sugar beets "are less likelyto result in weed resistance issues" (Kniss, 2010, p. 3). Approximately halfofthe GR weeds noted worldwideto date have been found in non-GR cropping systems (such as orchards). In the U.S., ofthe confirmed GR weeds, two evolved wherethere was no GR crop use (roadsides, vineyards, and tree crops) (Kniss, 2010a, p. 2). GR sugar beet production systems are differentthan other GR crops, in part because multiple year crop rotations are an integral component ofeffectweed and pest management programs for the sugar beet crop in all sugar beet growing regions (Kniss, 2010a, p. 3). Given thatthe sugar beet crop is susceptibleto many diseases, nematodes, and insects, multiple crop rotation is required to limitthe economic impactofthose pests. As such, sugar beet production grower agreementswith sugar processers will typically prohibit growers from planting a sugar beet crop in consecutive years (Kniss, 201Oa, p. 3). Instead, sugar beets are generally grown on a three- tofour-year rotation. While other GR crops may be included in the rotation with GR sugar beets (with the exact rotation varying in differentsugar beet growing regions) (Table 2-2), "the crop rotation in itselfwill reduce the potential for herbicide resistant weed developmentdueto changing cultural practices between crops (such as planting date, harvestdate, tillage practices, etc.)" (Kniss, 2010, p. 4).
As discussed above, the characteristics ofglyphosate itselfreduce the potential forthe developmentofherbicide resistance as compared to other herbicide families. As such, certain herbicidefamilies have been classified according to their risk ofresistant weed development. Beckie (2006) lists acetolactate synthase (ALS) and acetyl CoAcarboxylase (ACCase) inhibiting herbicides as "High" risk for resistance development, while glyphosate is considered a "Low" risk herbicideforthe development ofherbicide resistant weeds. ALS and ACCase inhibiting herbicides are commonly used in conventional sugar beet production, and weeds resistant to thesetwo herbicide groups are widely distributed across sugar beet growing regions ofthe U.S.

Event H7-1 Draft ER 120 Environmental Consequences 7/28/2010(Kniss, 201Oa, p4) (Figure 2-4). Glyphosatetolerant sugar beets can help delay resistance to these herbicides (Kniss, 2010, pp. 4 - 5): 

### In fact, glyphosate resistant sugar beet adds to the diversityof herbicide modes ofaction in many sugar beet crop rotations because it introduces a new mode ofaction (glyphosate) into the rotation with non-glyphosate-resistant crops, that tend to rely heavily upon acetolactate synthase ("ALS") inhibitors. ALS inhibiting herbicides pose afargreater risk ofdeveloping weed resistance than does glyphosate. By adding glyphosate to theircrop rotations, growers of

### GR sugar beet actually decrease the likelihood ofdeveloping resistance to ALS inhibitors, just as the use ofother crops and alternative modes ofaction in rotation with 

### GR sugar beet reduce the likelihood ofglyphosate resistant weeds.
Use ofherbicides with different modes ofaction, either concurrently orsequentially, is an importantdefense againstweed resistance (Weed Science Society ofAmerican [WSSA], 2010b). "Use ofa single product or mode ofaction forweed management is notsustainable. Some ofthe best and most sustainable approachesto prevent resistance include diversified weed management practices, rotation ofmodes ofaction and especiallythe use of multiple product ingredients with differing modes ofaction" (WSSA, 2010). The WSSA reports higher levels ofawareness among growers regarding the need to minimize the potential for developmentofglyphosate resistance: "In a market research studythat surveyed 350 growers in 2005 and again in 2009, in response to the question, 'are you doing anything to proactively minimizethe potential for resistance to glyphosateto develop,' 67% said yes in 2005 and 87% said yes in 2009" (David Shaw, as reported in WSSA, 2010). "In a 2007 survey of400 corn, soybean and cotton growers, resistance management programswere often or always used by 70% or more ofall three grower groups" (Frisvold and Hurley as reported by WSSA, 2010). There is widespread information available from universities and other sources regarding glyphosate resistance. Public universities (i.e. North Dakota State University, University of Minnesota), herbicide manufacturers ( i.e. www.weedresistancemanagement.com. www.resistancefighter.com) and crop commodity groups (i.e. National Corn Growers Association, American Soybean Association) have internetweb sites with information on prevention and managementofherbicide resistance. An example ofinformation provided by public universities is Dr. Don Morishita, a weed scientist atthe University of Idaho, who advises sugar beet growers on weed resistance management strategies (Dumas, 2008). The Sugar Industry Biotech Council provides weed resistance resources on its website. Monsanto includes information on weed resistance management practices in its Technology Use Guidethat is mailed annuallyto all licensed growers. Thesugar beet industry associations also hold annual
Event H7-1 Draft ER 121 Environmental Consequences 7/28/2010

### meetings where weed resistance management practices and other stewardship measures are included as part ofthe proceedings.

Sugar beet growers in particular have strong financial and practical interests in managing weeds effectivelyto reduce the development ofherbicide resistance in order to maximizeyield potential. Sugar beets are a high-value crop, and competition from weeds for moisture and light can negatively impactyields and the overall value ofthe crop. The development ofglyphosateresistantweeds harmsthe economic return peracre forthe individual farmer and the entire sugar beet industry (Cole, 2010a, p11).
As such, strategies and recommendations to delay the development ofglyphosate-resistant weeds have been developed forevent H7-1 sugar beets (TUG, Appendix E). Specifically, the TUG recommends the use of"mechanical weed control/cultivation and/or residual herbicides" with event H7-1 sugar beets, where appropriate, and "additional herbicide modes of action/residual herbicides and/or mechanical weed control in other Roundup Ready® crops" rotated with event H7-1 (TUG, 2010, p. 40). In addition to the financial incentive to followthese recommendations, all Roundup Ready technology users, including sugar beet growers, are contractually obligated through the Monsanto Technology Stewardship Agreement to follow the TUG.


### 3.12.3 Impactsummary 

## Alternative1 UnderAlternative 1, there would be no effect ofevent H7-1 on the potential forweeds to develop resistance to glyphosate, given that glyphosate use is minimal with conventional sugar beets. Growerswould continue to use conventional weed control methods, including other herbicide modes ofaction, to the extent such conventional herbicides are available (see Section 2.5). A return to conventional herbicides could have consequences for development offurther resistance to those herbicides. As discussed above, glyphosate use in GR sugar beet has proven to be an effective tool against weeds resistant to non-glyphosate herbicides, such as ALS-inhibitors and ACCase-inhibitors. If the planting of H7-1 sugar beets is substantially curtailed, a valuable tool for herbicide resistant weed managementwill be unavailableto sugar beet growers, and the impact ofweeds resistant

Event 

### H7-1 Draft ER 

### 122 Environmental Consequences 

### 7/28/2010to other herbicides may increase, although the impactwould likely be small since sugar beets are a relatively small crop (Kniss, 201Oa, p. 7). 

## Alternative2 UnderAlternative 2, impacts, ifany, with respect to the development ofglyphosate-tolerant weeds in sugar beet crops in thetimeframe considered in this ER are expected to be very small. First, sugar beets are a relatively small crop, (event H7-1 accounts for less than one percent of the glyphosate-resistant crops grown in the US), suggesting thatthe likelihood forthe developmentofnewglyphosate-resistantweed populations when compared to other herbicide resistant crops is smaller. Second, as discussed above, the nature ofglyphosate itselfand the growing practices for sugar beets makes it less likely that new glyphosate-resistantweed populations will develop in sugar beets as a result ofthe use ofglyphosate in sugar beets. Additionally, there is a high level ofawareness aboutthe potential for glyphosate resistant weeds and many readily available resources to assist growerswith managementstrategies. Indeed, event H7-1 growers are required to follow Monsanto's TUG, including its recommendations for adopting growing practices aimed at reducing the development of glyphosate-resistantweed populations. Finally, because herbicide resistance is a heritabletrait, ittakes multiple growing seasonsfor herbicide tolerantweeds to emerge and become the predominant biotype in aspecific area (Cole, 201Oa, p. 4). Researchers have concluded that even ifgrowers completely relied on only one herbicide, it is likelyto take at least five years for a herbicide-resistantweed population to develop (Kniss, 2010a, p4; Beckie 2006, Neve, 2008; Werth et aI., 2008). This is a reason why crop monitoring and follow up by University and industryweed scientist in cases ofsuspected resistance are important parts ofall herbicide resistance stewardship programs.



### 3.13 PHYSICAL 3.13.1 Land Use As discussed in Section 2.3, acreage planted in sugar beets in the US has changed little over the past 50 years (since 1961), ranging from a low of 1.1 million acres in 1982 (slightly lessthan the 2008 acreage) to a high of 1.6 million acres in 1975. Table 3-2 shows planted sugar beet acreage forthe lastsix years. While there have been changes within individual states, overall the range is small. As discussed in Section 2, a small part ofthe sugar beet crop was event

Event H7·1 Draft ER 123 Environmental Consequences 7/28/2010Table 3-2 Sugar BeetAcres Planted 2005 to 2010 Location 2005 2006 2007 2008 2009 2010 California 44,400 43,300 40,000 26,000 25,300 25,000 Colorado 36,400 42,100 32,000 33,800 35,100 29,800 Idaho 169,000 188,000 169,000 131,000 164,000 169,000 Michigan 154,000 155,000 150,000 137,000 138,000 147,000 Minnesota 491,000 504,000 486,000 440,000 464,000 445,000 Montana 53,900 53,600 47,500 31,700 38,400 42,400 Nebraska 48,400 61,300 47,500 45,200 53,000 46,000 North 255,000 261,000 252,000 208,000 225,000 227,000 Dakota Oregon 9,800 13,100 12,000 6,700 10,600 11,000 Washington 1,700 2,000 2,000 1,600

--- --- Wyoming 36,200 42,800 30,800 29,700 32,400 32,000 US Total 1,299,800 1,366,200 1,268,800 1,090,700 1,185,800 1,174,200 Source: USDA NASS, 2010

H7-1 in 2007, and in 2010, 95 percent ofthe planted crop was event H7-1. During this time period, the planted sugar beet acreage remained within the range of pre-event H7-1 plantings since 1961. As discussed in Section 2, sugar beet production is highly structured, vertically integrated, and centered on production facilities that are grower owned

.. To maintain a healthy industry, production cannot fluctuate much from yearto year: a certain level ofproduction is needed to supportthe major investment ofa processing facility, and a processing facility has limited capacity. The sugar beet grower is bound to the local processing facility and the local processing facility is bound to the sugar beet grower. Barring some unusual disruption in the industry, largefluctuations from yearto yearwould notbe expected. Crop data also provides no indication that the introduction and widespread adoption of GE crops in general has resulted in any significant change to thetotal US acreage devoted to agricultural production. The acres in the US planted to principal crops, which include corn, sorghum, oats, barley, winterwheat, rye, durum, spring wheat, rice, soybean, peanuts, sunflower, cotton, dry edible beans, potatoes, canola, proso millet, and sugar beets, has remained relatively constant overthe past 25 years (USDA NASS, 2010). From 1983 to 1995, the average yearly acreage of principal crops was 328 million (USDA NASS, 2010). Biotechnology-derived crops were Event H7-1 Draft ER 124 Environmental Consequences 7/28/2010

### introduced in 1996, and in 2009, 321 million acres ofprincipal crops were planted, which is not a significant change (USDA NASS, 2009a). 

## Alternative1 UnderAlternative 1, plantings ofevent H7-1 sugar beetwould be limited and only occur under notification or permit issued by APHIS. Growers would not have the option ofplanting event H7-1 sugar beets. Since sugar beet growers are farmers who also grow other crops, those who would have grown sugar beets could most likely grow some crop, but they could nevertheless suffer significant losses as a result (See Section 2.3). They may choose to grow conventional beets or other crops. A number offactors may influencethis decision, including availability of herbicides for conventional sugar beets, availability and cost ofspecialty cultivating equipment, availability ofdesirablevarieties ofsugar beet, and the potential penalty or lost ownership shares in the cooperative for not growing sugar beets. In the shortterm (the term considered by this ER), Alternative 1 could potentially result in a large decrease in sugar beet production. However, changes in land use would not be expected and the land use is likely to remain agricultural. 

## Alternative2
UnderAlternative 2, growers who choose to do so could continue to plant event H7-1 sugar beets. Sugar beet acreage would be expected to be similarto the levels ofthe past 50 years. Land use that is agricultural would be expected to remain so and other land usewould not be impacted.

3.13.2 AirQuality and Climate 

## Alternative1 UnderAlternative 1, plantings ofevent H7-1 sugar beetwould be limited and only occur under notification or permit issued by APHIS. Becausethe use ofglyphosate as a post-emergence herbicide has resulted and is expected to continue to result in an increase in conservation tillage practices, an increase in the use ofmechanical tilling would be expected underAlternative 1, if growerswould choose to plant conventional sugar beets. Ifgrowers would choose othercrops, the effects would depend on what the other crops would be. Emissions related to global
Event H7-1 Draft ER 125 Environmental Consequences 7/28/2010warming, ozone depletion, summersmog and carcinogenicity, among others, were found to be lower in glyphosate-tolerant crop systems than conventional systems (Bennett etaI., 2004). Therefore, Alternative 1would be expected to haveslightly greaterimpacts on air quality and climate, ifgrowers planted conventional sugar beets ratherthan event H7-1 sugar beets. 

## Alternative2 UnderAlternative 2, growerswho choose to do so could continue to plant event H7-1 sugar beets. The continued use ofevent H7-1 sugar beets may result in continued increases in conservation tillage, as discussed in Section 2 (changing to conservation tillage practice is gradual, as itoften requires different management practices and often requires new equipment). Therefore, Alternative 2 would lead to a small but positive impact on airquality and climate relative to Alternative 1. 

### 3.13.3 Surfacewaterquality Surfacewater may be impacted from sugar beet production by runofffrom sugar beet fields that carries soil particles and herbicides orother pesticides to streams, rivers, lakes, wetlands and otherwater bodies. As discussed below, based on existing data, the soil component ofrunoff is a much more important contributorto surface water impacts than is the pesticide component. 

## Alternative1 UnderAlternative 1, plantings ofevent H7-1 sugar beetwould be limited and only occur under notification or permit issued by APHIS. UnderAlternative 1, growerswho are now growing event H7-1 sugar beets and who would choose to grow conventional sugar beets would need to use other practices forweed management. These practices would likely consist of some combination ofherbicide use and increased tillage (beyond conservation tillage).
IfAlternative 1would result in increased use oftillage for weed control, overall adverse surface water impacts are likely to be greaterthan with Alternative 2. Tillage causes widespread soil disturbance. Thus, wind and water erosion, topsoil loss and the resulting sedimentation and turbidity in streams are likelyto increase with increased tillage. In 2009, based on the states' water quality reports, EPA identified sedimentation and turbidity as two ofthe top 10 causes of impairmentto surface water in the U.S. in general; in 2007, EPA identified sedimentation/siltation as the leading cause of impairmentto rivers and streams in particular (EPA, 2009, p. 15; EPA, 2007, p. 9). Although a comprehensive data set has notyet been developed to prove the point, EPA has projected conservation tillage to be "the major soil

Event H7-1 Draft ER 126 Environmental Consequences 7/28/2010

### protection method and candidate best management practice for improving surface water quality" (EPA, 2002). EPA identifies conservation tillage as the first of its CORE 4 agricultural management practices forwater quality protection (EPA, 2008a).
Based on the states' waterquality reports to EPA, which EPA makes available through its NationalAssessment Database, pesticides in general and herbicides in particular are a relatively minor contributorto impairment ofsurface water in the U.S., compared to sedimentation/siltation and turbidity (EPA 2008b). Ofthe pesticides that were reported as contributing to impairment, almost all are previously used, highly persistent chemicals that are no longer registered for use in the U.S. Only one herbicide, atrazine, was found (EPA 2008b).
In summary, based on EPA data, herbicides in general are very minorcontributors to surface water impairment in the U.S., whereas sedimentation/siltation and turbidity are major contributors. Alternative 1, compared with Alternative 2, would likely result in a different mix of herbicides used and may result in increased tillage. Increased tillage could contribute to adverse surface water impacts through increased runoffofsoil particles to surface water bodies. 

## Alternative2 Alternative 2would result in continued application ofglyphosate herbicidesto event H7-1 sugar beets. Herbicides that adsorb strongly, such as glyphosate, are less likelyto degrade or volatilize (USDA APHIS, 2009). Other herbicides used on sugar beets have varying chemical fates, but, in general, most are more persistent and are characterized by higher mobility in soils, making them more aptto continually contaminate surrounding water systems.



### 3.13.4 Groundwaterquality 

## Alternative1 UnderAlternative 1, ifgrowers choose to grow conventional sugar beets, the potential for impacts to groundwaterwould be similarto that priorto the widespread adoption ofevent H7-1 sugar beets. If herbicides are used thatdo not bind strongly to soil particles, and have a higher potential to leach into groundwater, the potential for migration to groundwater may be higher than with Alternative 2.

Event H7-1 Draft 

### ER 127 Environmental Consequences 7/28/2010

## Alternative2 Because glyphosate binds strongly to soil, and has a low potential to leach into groundwater, it is unlikelyto impact groundwater. 

### 3.14 BIOLOGICAL Potential environmental effects of pesticide use are carefully considered as a part ofthe FIFRA pesticide registration process. Priorto the approval ofa new pesticide or a new use ofthat pesticide (including a change in pesticide application rates and/or timing) and before reregistering an existing pesticide, EPA must considerthe potential for environmental effects and make a determination that no unreasonable adverse effects to the environmentwill be caused by the new pesticide, new use orcontinued use. To make this determination, EPA requires a comprehensive set ofenvironmental fate and ecotoxicological data on the pesticide's active ingredient (US 40 CFR Part 158). EPA uses these data to assess the pesticide's potential environmental risk (exposure/hazard). The required data include both short- and long-term hazard data on representative organisms that are used to predict hazards to terrestrial animals (birds, nontarget insects, and mammals), aquatic animals (freshwaterfish and invertebrates, estuarine and marine organisms), and nontarget plants (terrestrial and aquatic). Information regarding the impacts ofglyphosate on the biological environment is summarized below. Additional information on this topic is also being considered in the USDAAPHIS Draft Environmental Impact Statement (DEIS) on the Deregulation ofGlyphosateTolerantAlfalfa (Docket No. APHIS-2007-0044). This information is applicable to the use ofglyphosate in event H7-1 sugar beet since the maximum single in-crop application rate forGT alfalfa (1.55 Ib a.e.lA) is greaterthan the maximum single in-crop application rate for sugar beet (1.125Ib a.e.lA). 

### 3.14.1 Plant andAnimal Exposure

### to Glyphosate



### Animals The equivalence ofthe CP4 EPSPS enzyme to native EPSPS exceptfor tolerance to glyphosate is discussed in Sections 3.1 and 3.11. A number of researchers have conducted laboratory investigationswith differenttypes ofarthropods exposed to genetically engineered crops containing the CP4 EPSPS protein (Goldstein, 2003; Boongird et aI., 2003; Jamornman,

Event H7-1 Draft ER 

### 128 Environmental Consequences 7/28/2010

### etaI., 2003; Harvey et aI., 2003). Representative pollinators, soil organisms, beneficial arthropods and pest species were exposed to tissues (pollen, seed, and foliage) from GE crops that contain the CP4 EPSPS protein, to evaluate potential toxicity. These studies, although varying in design, all reported a lack oftoxicity observed in various species exposed to these crops (Nahas etaI., 2001; Dunfield and Germida, 2003, Siciliano and Germida 1999).

As a part ofthe reregistration evaluation under FIFRA, EPA conducted an ecological assessmentfor glyphosate. This assessment compared the results from toxicity tests with glyphosate conducted with various plant and animal species to a conservative estimate of glyphosate exposure in the environment, the Estimated Environmental Concentration (EEC)

.. Glyphosate is practically nontoxicto slightlytoxic to birds, freshwaterfish, marine and estuarine species, aquatic invertebrates and mammals and practically nontoxic to honey bees (which are used to assess effects on nontarget insects in general) (EPA, 1993, pp. 50, 38
- 40, 45, 47, 48
- 50). Glyphosate has a low octanol-water coefficient, indicating that it has atendency to remain in the water phase ratherthan move from the water phase into fatty substances; therefore, it is not expected to accumulate in fish or other animal tissues.
In the Reregistration Eligibility Decision (RED) for glyphosate (EPA, 1993, p. 53), the exposure estimates were determined assuming an application rate of5.06251b a.e., which exceeds the maximum labelled use rate for a single application for agricultural purposes. When the EECs were calculated for aquatic plants and animals, the direct application ofthis rate to waterwas assumed. Based on this assessment, EPA concluded that effects to birds, mammals, fish and invertebrates are minimal based on available data (EPA, 1993).
The glyphosate end-use products used in agriculture contain a surfactantto facilitate the uptake of glyphosate into the plant (Ashton and Crafts, 1981). Depending on the surfactant used, the toxicity ofthe end-use product may range from practically nontoxic to moderately toxic to fish and aquatic invertebrates (EPA, 1993, pp. 42
- 45). For this reason, the 1993 Glyphosate RED stated that some formulated end-use products of glyphosate needed to be labeled as "Toxic to fish" ifthey were labeled for direct application to water bodies. Due to the associated hazard to fish and other aquatic organisms, glyphosate end-use products that are labeled for applications to water bodies generally do not contain surfactant, or contain a surfactant approved for direct application to water bodies.
Event H7-1 Draft ER 129 Environmental Consequences 7/28/2010

### SoilMicroorganisms Microorganisms produce aromatic amino acidsthrough the shikimate pathway, similarto plants. Since glyphosate inhibits this pathway, it could be expected that glyphosatewould be toxic to microorganisms. However, field studies showthat glyphosate has little effect on soil microorganisms, and, in some cases, field studies have shown an increase in microbial activity dueto the presence ofglyphosate (USDA FS, 2003). Based on the data available on glyphosate usage, chemical fate, and toxicity, glyphosate is not expected to pose an acute or chronic risk tothefollowing categories ofwildlife: (EPA, 1993)



### • birds,



### • mammals,



### • terrestrial invertebrates,


### • aquatic invertebrates, and


### • fish

• soil microorganisms 

### Alte1'1lative 1 UnderAlternative 1, the potential for impacts to animal species may be greaterthan with Alternative 

### 2 because ofthe return to greater use ofadditional herbicides, potentially with higher toxicities. 

### Altemative2 As stated previously, Alternative 

### 2 is expected to result in the continued use and application of glyphosate-based herbicideformulations. This could result in continued glyphosate exposureto animal species within and adjacentto those fields through drift, as discussed previously, and a decrease in exposureto other herbicidesfrom runoffand! or drift (USDAAPHIS, 2009)

.

. . . . .Considering the potential for aquatic exposureto glyphosateformulations from terrestrial uses, EPA recently evaluated the effect ofglyphosate and its formulations on another amphibian species, the California red-legged frog, and concluded that aquatic exposureto

Event H7-1 Draft ER 130 Environmental Consequences 7/28/2010glyphosate or its formulations posed no risk to this threatened species (EPA, 2008b). Because EPA considered awide range ofapplication rates in their evaluation forthe red-legged frog, this conclusion can also be applied to amphibians exposed to glyphosatefrom applications on event H7-1 sugar beet. Any possible adverse impacts to amphibians resulting from the deregulation ofevent H7-1 sugar beet may be offset by the shiftfrom other herbicides used in sugar beet cultivation, which are considered to have higher environmental impacts in general.

. Additionally, amphibian habitat in watersheds where event H7-1 sugar beet is produced could be improved through conservation tillage, resulting in decreased soil erosion, decreased sedimentation in runoff, and decreased turbidity in ponds, lakes, and rivers fed by surface waters. 

## Plallts Glyphosate is a non-selective herbicide with post-emergence activity on essentially all annual and perennial plants. As discussed in Section 3.1.1, this activity is dueto inhibition ofEPSPS, an enzyme involved in aromatic amino acid synthesis. As with any herbicide, a risk exists that spray drift could pose issues for plants on the borders ofthe target fieldHowever, EPAtakes the potential forspray drift into accountwhen conducting the risk assessment it uses to establish pesticide application rates and direction for use, which are designed to minimize spray drift risks

.. As discussed earlier, glyphosate binds tightly to agricultural soils and is not likelyto move offsite dissolved in water. Moreover, glyphosate is nottaken up from agricultural soil by plants. However, because drift is a potential means ofexposureto non-target plants adjacentto an event H7-1 sugar beetfield; Monsanto conducted a threatened and endangered (TE) species risk assessmentto evaluate the impacts to plants (and animals) from the use of glyphosate-based herbicides in conjunction with glyphosate-tolerant plants. The complete assessmentwas submitted to APHIS and has been reviewed by APHIS scientists to support the petition for deregulation ofglyphosate-tolerant alfalfa. The assessment is available on the APHIS, BRS website at http://www.aphis.usda.gov/biotechnology/alfalfa_documents.shtml

The assessment identified some plant, but no animal, speciesforwhich glyphosatewhen aerially applied could pose issues in areas bordering fields in certain locationswhere sugar beets are grown. To address any such risks, Monsanto developed Pre-Serve, aweb-based program designed to eliminate any potential impacts on TE plants resulting from the agricultural use of herbicides that contain glyphosate.

Event H7-1 Draft ER 131 Environmental Consequences 7/28/2010Pre-Serve instructs growers to observe specific precautions when spraying glyphosate herbicides on Roundup Ready® crops nearTE plant species that may be at risk. Only a very small percentage ofglyphosate applications will require mitigation measures. This is because the vast majority ofU.S. cropland is outside ofthe Pre-Serve Use Limitation Areas
- areas wherethreatened or endangered plant species may be present- and most glyphosate applications are made using ground application equipment at rates below

### 3.5 pounds ofactive ingredient per acre (Ib a.e./acre), which will not impactthe TE plant species.
Growerswho are licensed to purchase and use seeds containing Roundup Ready®technology are required contractually to followthe requirements in Monsanto'sTechnology Use Guide. This includes the requirement to accessthe Pre-Serve website (www.pre-serve.org) or contact Monsanto before applying glyphosate-based herbicide products to crops grown from these seeds. This website will guide growers and applicators through a user-friendly, four-step process to determinewhethertheirfields are locatedwithin Use Limitation Areas and, ifso, to identifythe mitigation measuresthat must betaken. Forfields located within Use Limitation Areas, the following mandatory steps must betaken to reduce potential risks to TE plant species:
• Ground applications are limited to rates of less than 

### 3.5 Ib a.e./acre (most uses).
• Aerial applications may be prohibited in bufferzones along perimeters offields. The size ofbufferzones can be minimized by employing a coarser spray droplet size.
• In specified counties, aerial applicators will be required to observe a new maximum use rate of0.92 Ib a.e./acre (26 fl. 

### ozlA Roundup PowerMAX® orWeatherMAX®) ifusing medium spray droplets'9, but can applythe currentfull labeled rate 

### (1.55 Ib a.e./acre or 

### 44 fl. 

### ozlacre of Roundup PowerMAX orWeatherMAX) ifusing coarse spray droplets.

In addition to the instructions provided by Pre-Serve, mitigationsfrom local, state orfederal protection programs 

### andlorlandowner agreements may apply. Monsanto's licensees are required to follow these measures where applicable.

.

® Roundup Ready is a registered trademark ofMonsanto Technology LLC. 39 In counties where listed plant species observations wefe present, but not within 250 ft ofa relevant land use, actual separation distance was not assessed. In these counties aerial application rates with medium sized droplets are restricted to 0.92 Ib a.e.lacre to avoid exposure to listed TE plant species that might be within 417 It ofthe application area, and thus within an area where aerial application at 1.55 Ib a.e./acre using medium-sized spray droplets would present a potential risk based on the Tier 1 assessment. This restriction will be eliminated in many cases by further distance assessments. Event H7-1 Draft ER 

### 132 Environmental Consequences 7/28/2010The Pre-Serve web-based system, as described above, enables growers and applicators to take steps where necessaryto avoid potential effects to TE plant species from application of glyphosate-based agricultural herbicides.


## Alternative1 UnderAlternative 1, the rates and volumes ofglyphosate applications on sugar beet crops would likely return to the level of use that existed priorto the deregulation ofevent H7-1 sugar beets. Growerswould use an array ofother herbicides, some ofwhich may be applied at greatervolumes compared to glyphosate. The herbicides used in conventional sugar beet systems have been found, in general, to have somewhatgreater human health orenvironmental impacts than glyphosate (USDA, 

### 2004). This is consistentwith the EPA decision to grant reduced risk status forglyphosate use in glyphosate-tolerant sugar beets.

### Error! 

### Bookmark not defined. Comparison ofresults from terrestrial and aquatic plant studies with predicted exposure from herbicide use suggests that most ofthe herbicides used in conventional sugar beet systems may have more effectthan glyphosate on aquatic orterrestrial plant species. These herbicides are selective herbicidesthat kill only particulargroups ofplants such as annual grasses, perennial grasses, or broadleafweed species and thus require the use of morethan one herbicideto achieve satisfactoryweed control. 

## Alternative2 Alternative 2 is expected to result in continued use and application ofglyphosate-based herbicideformulations. This could result in some incidental glyphosate exposure to terrestrial and aquatic plants in the vicinity ofevent H7-1 beetfields by spray drift. The EPA has concluded that glyphosate use on event H7-1 sugar beet can be considered to pose reduced risk compared to other herbicides used forweed control in conventional sugar beets40

. . Hundreds ofmillions ofacres ofother GT crops have been treated with glyphosatefor over ten years with minimal impactto adjacent non-targetterrestrial plants including crops when appropriate drift minimization measures are practiced. Because glyphosate binds strongly to soil particles and has no herbicidal activity after binding to soil, no effects on aquatic plants will result from surface water runofffrom glyphosate use on event H7-1 sugar beet in accordance with labeled directionsfor use.. Conservation tillage and no tillage practices that are possible

40 A reduced risk decision is made at the use level based on a comparison between the proposed use of the pesticide and existing alternatives currently registered on that use site. A list of decisions regarding Reduced Risk Status can be found at http://www.epa.gov/opprd001/workplan/reducedrisk.html Event H7-1 Draft ER 133 Environmental Consequences 7/28/2010

### when glyphosate is used have the potential to decrease surface water runoffand sedimentation which further benefits aquatic organisms.

3.14.2 Threatened and 

### Endangered Species As the action agency for pesticide registrations EPA hasthe responsibilityto conduct an assessment ofeffects 

### ofa registration action on endangered species. The EPA Endangered Species Protection Program web site, http://www.epa.gov/espp/, describes the EPA assessment process for endangered species. Some ofthe elements ofthat process, generally taken from the web site, are summarized below.
When registering a pesticide or reassessing the potential ecological risks from use ofa currently registered pesticide, EPA evaluates extensive exposure and ecological effects 

### data to determine how a pesticide will move through and break down in the environment. Risks to birds, fish, invertebrates, mammals and plants are routinely assessed and used in EPA's determinations ofwhether a pesticide may be licensed for use in the U.S.
EPA's core pesticide risk assessment and regulatory processes ensure that protections are in place for all populations ofnontarget species. Because endangered species may need specific protection, EPA has developed risk assessment procedures described in the Overview ofthe Ecological RiskAssessment Process (U.S. EPA, 2004d, p. 7) to determinewhether individuals ofa listed species have the potential to be harmed by a pesticide, and ifso, what specific protections may be appropriate. EPA's conclusion regarding the potential risks a pesticide may pose to a listed species and any designated critical habitatforthe species, after conducting a thorough ecological risk assessment, results in an "effects 

### determination."
As a part ofthe endangered species effects 

### assessmentfor the California red-legged frog, EPA evaluated the effect

### ofglyphosate at rates up to 7.95 Ib a.e.lA on fish, amphibians, aquatic invertebrates, aquatic plants, birds, mammals, and terrestrial invertebrates. This assessment determined that at the maximum application rate for in-crop applications ofglyphosate to GT sugar beets (1.125Ib a.e.lA) there would be no effects 

### ofglyphosate on the following taxa of threatened and endangered species: fish, amphibians, birds, and mammals. EPA also determinedthat glyphosateformulations would have no effect

### on threatened or endangered fish, amphibians, birds, and mammals. Although not specifically discussed in the assessment, from the EEC's and effects 

### endpoints presented, it can also be determined thatthere would be
Event H7-1 Draft ER 134 Environmental Consequences 7/28/2010

### no effects ofglyphosate or its formulations on threatened orendangered vascular aquatic plants, and aquatic invertebrates (EPA, 2008b).2008). non-endangered small .H7-1

.
Monsanto has designed a web-based program (www.Pre-Serve.org), designed to ensure no effect of glyphosate applications on threatened and endangered plant species. Pre-Serve instructs growers to observe specific precautions when spraying glyphosate herbicides on glyphosate-tolerant crops near threatened and endangered plant species that may be at risk. According to the U.S. Fish and Wildlife Service Endangered Species website, there are no TE terrestrial invertebrates in Colorado, Idaho, Nebraska, North Dakota, South Dakota, and Wyoming. 41 

### In other states, TE small terrestrial invertebrates, if present, are at no more risk than from applications ofglyphosateto conventionally grown sugar beets.


## Alternative1 UnderAlternative 1, the potential for impacts to threatened and endangered species may be greaterthan with Alternative 2 because ofthe use ofcertain herbicides with potentially higher toxicities. 

## Alternative2 As indicated, EPA is responsible for and has previously conducted analyses regarding glyphosate impacts. Onlytwo percent ofglyphosate is applied aerially to all agricultural crops in the US (USDA APHIS, 2009). Given that aerial application in event H7-1 sugar beets is not expected to be any differentthan other agricultural production systems, approximatelytwo percent ofglyphosate used in event H7-1 sugar beets is expected to be applied aerially. Additionally, the use ofbufferzones, based on the Pre-Serve program, between the sugar beet field and any potential threatened orendangered plant populations can prevent any adverse impacts dueto drift ofglyphosatefrom aerial applications (USDA APHIS, 2009), so thatthere will be no effect on endangered species. We evaluated the potential for deleterious effects orsignificant impacts on non-target organisms, including those on the US Fish and Wildlife Service (USFWS) threatened and endangered species list, from cultivation ofevent H7-1 sugar beet and its progeny. The enzyme CP4 EPSPS that confers glyphosatetolerance isfrom the bacterium Agrobacterium sp. strain CP4. This gene is similar to the genethat is normally present in sugar beets and is not known

41 

### http://www.fws.gov/endangered/species/index.htmI Event H7-1 Draft ER 135 

### Environmental Consequences 7/28/2010

### to have any toxic property (Schneider, 2003). Field observations ofevent H7-1 sugar beet event H7-1 revealed no negative effects on non-target organisms (Schneider, 2003). The lack of known toxicity forthis enzyme suggests no potential for deleterious effects on beneficial organisms such as bees and earthworms. The high specificity ofthe enzyme for its substrates makes it unlikelythat the introduced enzyme would metabolize endogenous substrates to produce compounds toxic to beneficial organisms (Schneider, 2003). 

### 3.15 HUMAN HEALTH AND SAFETY 3.15.1 Consumer Health and Safety 

### AlternatiJ1e1 UnderAlternative 1, the potential for impactsto consumers may be greaterthan with Alternative 2 because ofthe use ofherbicides with highertoxicities. 

### AlternatiJ1e2 The general public is not at a high risk ofexposure to substantial levels ofglyphosate under typical use conditions (EPA, 1993; USDA FS, 2003). UnderAlternative 2, exposure to glyphosate would not increase beyond that currently experienced, since 95 percent ofsugar beet is already event H7- 1. According to the EPA Glyphosate Fact Sheet (1993) glyphosate is of relatively loworal and dermal acute toxicity and has been placed in Toxicity Category III for these effects (Toxicity Category I indicates the highest degree of acute toxicity, and Category IV the lowest). The acute inhalation toxicity study was waived by EPA because glyphosate is nonvolatile and available adequate inhalation studies with end-use products show lowtoxicity. The use ofglyphosate herbicide does not appearto result in adverse effects on development, reproduction, or endocrine systems in humans and other mammals. Under present and expected conditions of use, glyphosate herbicide does not pose a health risk to humans (EPA, 1993). Additionally, the nature ofglyphosate residue in plants and animals is adequately understood, and studies with a variety ofplants indicate that uptake ofglyphosatefrom soil is limited. The material that is taken up is readily translocated throughout the plant. In animals, ingested or absorbed most glyphosate is essentially not metabolized and is rapidly eliminated in urine and feces. Enforcement methods are available to detect residues ofglyphosate in or on plant commodities, in water, and in animal commodities (EPA, 1993).

Event H7-1 Draft ER 136 

### Environmental Consequences 7/28/2010EPA conducted a dietary risk assessmentfor glyphosate based on aworst-case risk scenario, that is, assuming that 100 percent ofall possible commodities/acreage were treated, and assuming thattolerance-level residues remained in/on all treated commodities. Based on the assessment, EPA concluded thatthe chronic dietary risk posed by glyphosatefood uses is minimal (EPA, 1993). The addition ofanother GT crop to agricultural production may lead to a greater chance that a GT crop, including GTsugar beets may be grown near otherfood crops. This could lead to higher exposure to glyphosate in the diet ofthe general public because there would be a greater chance for glyphosate residue to reach food crops via spray drift. Nonetheless, such increase risk ofexposureto glyphosate residue will not result in increased risks tothe general population because the current upper estimates ofrisk are based on highly conservative fruit and vegetable intake rates with an assumed high estimated amount ofglyphosate residue. Glyphosate is registered for use as a directapplication to weeds in several fruits and vegetables and tolerances are established in the consumable commodities ofthese crops. The current aggregate dietary risk assessment completed by EPA concludes there is no concern for any subpopulation regarding exposure to glyphosate, including the use on manyfruits and vegetables and GT sugar beet (71 FR 76180, 2006). Moreover, the potential exists for decreases in the applications and subsequent residues ofmore toxic herbicides ifGTsugar beet is deregulated. 3.15.2 Hazard Identification and ExposureAssessmentfor Field Workers 

### Alte1'l1atiJle 1 UnderAlternative 1, the potential for impactsto field workers may be greaterthan with Alternative 2 because ofthe increased need for hard laborto remove weeds and the use of herbicideswith highertoxicities. 

### Alte1'l1atiJle2 According to the RED documentfor glyphosate (EPA, 1993), glyphosate is of relatively low oral and dermal acute toxicity. Forthis reason, glyphosate has been aSSigned to Toxicity Categories III and IV forthese effects (i.e., Toxicity Category I indicates the highestdegree ofacute toxicity, and Category IVthe lowest). An acute inhalation study was waived by EPA because glyphosate is a non-volatile solid, and the studies conducted on the end-use product formulation are considered sufficient (EPA, 1993). Experttoxicological reviews from US EPA (1993) and the World Health Organization (WHO, 2004) are in agreementthat glyphosate does not pose

Event H7-1 Draft ER 137 Environmental Consequences 7/28/2010

### any human acute exposure concerns for dietary exposures and thus negated the need to establish an acute reference dose. With regard to subchronic and chronictoxicity, one ofthe more consistent effects ofexposure to glyphosate at high doses is reduced body weight gain compared to controls. Body weight loss is not seen in multiple subchronic studies, but has attimes been noted in some chronic studies at excessively high doses", 20,000 ppm in diet (WHO, 2004). Other general and non-specific signs oftoxicity from subchronic and chronic exposure to glyphosate include changes in liver weight, blood chemistry (may suggest mild livertoxicity), and liver pathology (USDA FS, 2003). Glyphosate is not considered a carcinogen; it has been classified by EPA as a Group E carcinogen (evidence ofnon-carcinogenicityfor humans) (EPA, 1993; 2006). EPA has considered in its human health analysis the potential applicatorand bystander exposure resulting from increased glyphosate use. Based on the toxicity ofglyphosate and its registered uses, including use on glyphosate-tolerant crops, EPA has concluded that occupational exposures (short-term dermal and inhalation) to glyphosate are not ofconcern because no short-term dermal or inhalation toxicity endpoints have been identified for glyphosate (71 FR 76180, 2006). Additional evidence to support the EPA conclusion can be found in the Farm Family Exposure Study, 

### a biomonitoring study ofpesticide applicators conducted by independent investigators (Acquavella, et al. 2004). This biornonitoring study determinedthatthe highest estimated bodily adsorption ofglyphosate as the result of routine labeled applications of registered glyphosate-based agricultural herbicidesto crops, including glyphosate-tolerant crops, was approximately 400times lowerthan the RID established for glyphosate. Furthermore, investigators deterrnined that40 percent ofapplicators did not have detectable exposure on the day ofapplication, and 54 percent ofthe applicators had an estimated bodily adsorption of glyphosate rnore than 1000 times lowerthan the RID (Acquavella, etat., 

### 2004). Use patterns and rates forglyphosate tolerant sugar beet are typical ofmost glyphosate agronomic practices. Therefore, the deregulation of glyphosate-tolerant sugar beetwould not Significantly increase the exposure risk to pesticide applicators. Finally, the biomonitoring study also found little evidence ofdetectable exposure to individuals on the farrn who were notactively involved in or located in the imrnediate vicinity oflabeled applications ofglyphosate-based agricultural herbicidesto crops. Considering the similarity of the use pattern and application rates ofthe glyphosate products in this study cornpared to those
Event 

### H7-1 Draft ER 

### 138 Environmental Consequences 

### 7/28/2010

### registered for use on glyphosate-tolerantsugar beet and glyphosate-tolerant crops in general, bystanderexposure attributed to the use ofglyphosate on glyphosate-tolerant crops is expected to be negligible. Therefore, the use ofcurrently registered pesticide products containing glyphosate in accordance with the labeling will not pose unreasonable risks or adverse effects to humans orthe environment. 

### In general, the herbicidal activity ofglyphosate is due primarily to a metabolic pathwaythat does not occur in humans orother animals, and, thus, this mechanism ofaction is notdirectly relevant to the human health risk assessment. EPA considers glyphosate to be of low acute and chronic toxicity by the dermal route ofexposure. Glyphosate is considered a Category IV dermal toxicant and is expected to cause only slight skin irritation (USDA APHIS, 2009). 

### 3.16 ECONOMIC IMPACTS 3.16.1 Sugar beet processing Approximately 54% ofthe U.S. domestic sugar production comes from sugar beets (USDA Farm Service Agency [FSA], 2010). Refined sugarfrom sugar beets is the product ofa multiyear cycle and involves beetseed suppliers, sugar beet growers, sugar beet processors, sugar users and consumers (USDA FSA, 2010). As part ofthat process, beet seed suppliers plantthe commercial sugar beet seed crop in thefall ofYear 1, which produces the commercial seeds harvested in the fall ofYear2. The commercial seed is processed over the winter and sold to sugar beet growerswho plant it in the spring. Sugar beet growers harvestthe beet root in the fall ofYear3 and deliverthem to beet processing facilities owned by the beet processors. Beet sugar is extracted by beet processors beginning in the fall ofYear 

### 3 and throughout Year4. The sugar produced from these beets is purchased by food manufacturers and consumers (USDA FSA, 2010). Ofthe sugar beet root crop planted in the spring of2009, 95 percentwas reported to be event H7-1 sugarbeet seed. This is also the same forthe sugar beet root crop planted in the spring of2010, and harvested in the fall of201

### O. This represents 98 percent ofthe sugar beet root crop outside ofCalifornia, where, as discussed in Section 2, event H7-1 has not been grown (USDA FSA, 2010). The harvesting ofthe 2010 root crop will begin between late August and early September, depending ofthe projected size ofthe sugar beet crop. The biggerthe crop, the earlierthe harvestwill begin to make sure it is completed before the ground freezes. By late August, most ofthe crop's sugarwill have been contracted for sale (USDA FSA, 2010). The economic impact ofpreventing that crop from being harvested and processed is discussed below. Event 

### H7-1 Draft 

### ER 139 Environmental Consequences 

### 7/28/20103.16.2 USDA's role in sugar marketing The domestic sugar market is closely managed by USDA's sugar program and therefore, not governed solely by supply and demand. USDA controls domestically produced sugarthrough the Flexible Sugar Marketing Allotment Program, and controls foreign importsthrough the raw and refined sugartariff-rate quotas (TRQs). Unlimited amounts of refined sugar can be imported undera high duty of 16.3 cents per pound and raw sugar of 15.36 cents per pound. Under section 156 ofthe Federal Agriculture Improvementand Reform Act of 1996, as amended by the Food Conservation, and Energy Act of2008 (the Farm Bill), and the Harmonized Tariff Schedule ofthe United States (HTS). USDA is required to establish a range ofacceptable market conditions, which means maintaining a price floor in potentially oversupplied situations by removing surplus supply, and maintaining "adequate supply" in potentially undersupplied market situations (USDA FSA, 2010). The minimum raw and refined sugar pricesthatthe sugar program mustsupport are the levels thatwould cause sugar beet and sugarcane processors to forfeit their sugar thatwas put up as collateral underthe USDA sugar nonrecourse loan program. Sugar nonrecourse loans support raw cane sugar prices at 21 cents per pound and refined beet sugar prices at 24 cents per pound. The nonrecourse loans support price because forfeiting the sugar collateral completely extinguishesthe borrower's debt, thus sugar beet and sugarcane processors are assured ofgetting at leastthe USDA loan proceeds fortheirsugar. Loan collateral forfeiture also removes surplus sugar out ofthe market becausethe govemment is limited by the Farm Bill in its sugar disposal options (USDA FSA, 2010). Atthe other end ofthe range, the objective of maintaining "adequate supply" (as described in the Farm Bill) or "adequate supply at reasonable prices" (described in HTS) requires USDAto increase supply undertight markets, which will make domestic prices lowerthan they would otherwise be. However, there is no maximum sugar price strategy stipulated in federal law, as there is a minimum sugar price. Underthe Flexible Sugar Marketing Allotments Program, the sugar beet processors are guaranteed a market share of46 percent ofthe domestic market. If the sector cannot fulfill its quota, USDA is required to increase imports to maintain adequate supply (USDA FSA, 2010). 3.16.3 Economic Impacts

Event H7-1 Draft ER 140 Environmental Consequences 7/28/2010

### Alternative 2 is not expected to result in adverse economic impacts. Growers and seed producers would continue to use and sell event H7-1 seed and crops and seek return on their investments. This section discusses the economic impacts ofAlternative 1. 

## Economicimplicationsof ahaltill eventH7-1 sugarbeetcultivation
Should the unrestricted use ofevent H7-1 sugar beets be impacted, effectively removing the productfrom the market, an estimated 4.25 million tons ofbeet sugarwould be removed from the market (USDA FSA, 2010). This sugar is expected to supply about40 percent of U.S. sugar consumption during 2011. Becausethefederal government has a major effect on sugar supply, and hence sugar price, the market reaction to a reduction in refined beet sugar is somewhat determined by USDA's supply management response. USDA has recently reacted to two similar, but smaller, events in 2005 and 2008 (temporary loss ofcane refineries) that demonstrate the potential effectfrom a reduction in sugar. In both cases, U.S. refined sugar prices averaged about 18 cents per pound above the world refined sugar price, even as USDA increased the world refined quota to moderate U.S. sugar prices (USDA FSA, 2010). However, an action thateffectively precludes further planting, cultivation, processing, or other use ofevent H7-1 sugar beets would cause greater disruption and greater harm to the U.S. sugar marketthan caused by the 2005 or2008 disruptions because the reduction, 4.25 million tons, is 20 times largerthan the loss ofsupply in 2005 and 10 times largerthan the loss in 2008 (USDA FSA, 2010). Prices increased substantially in those years, butwere never high enough to cause sugarto be imported offthe world market atthe high tariff rate of 16.3 cents per pound. Underthe scenario where event H7-1 sugar beet is effectively precluded, world sugar could enter undera high tariffand setthe refined price in the U.S. market (USDA, 2010). Additionally, USDA learned from the temporary loss ofcane refineries in 2005 and 2008 that many U.S. food manufacturers have difficulty using imported refined sugar because of differences in product quality or packaging. Afterthe 2005 and 2008 events, a new business developed to clean, repackage, or liquefy imported refined sugarfor domestic use. This was required because domesticfood companies would not use the crystallized imported sugar in its original packaging (USDA FSA, 2010). U.S. sugar cane refiners are expected to run at nearfull capacity in 2011, therefore, they will not have the capacity to refine imported raw cane sugar to replace the 4.25 million tons ofbeet
Event H7-1 Draft ER 141 Environmental Consequences 7/28/2010

### sugar lost. Normally, USDA would increase the raw sugarTRQ to alleviate domestic sugar shortages. However, in 2011, domestic needs forsugarwould have to be filled by increasing refined sugar imports by 6times from an average of690,000 tons overthe past 3 years (USDA FSA,2010). This increase in refined sugar imports may cause an extensive disruption in the current refined sugar distribution system. For example, the 2.6 million tons would require about 250,000 containers on at least 330 ships by the end ofSeptember 2010 (USDA FSA, 2010). Ifsugar beet root crop growers cannot harvest, they will experience an economic hardship because they will have incurred all the costs ofproducing the 2010 root crop exceptfor harvesting. Further, they would incurthe cost to destroythe cropto preparethe land forthe next crop, and to preventthe sugar beet root crop from overwintering and reaching the flowering stage in 2011. Sugar beet processors are currently contracting FY 2011 beet sugar at 38 cents per pound (USDA FSA, 2010). Therefore, sugar beet growers and cooperative owners would also experience lost revenue estimated at$3.23 billion (4.25 million tons X 0.38 $llb 

### X 2000 Ibs/ton) (USDA FSA, 2010). Sugar beet processing factories, and the local economies organized around them, would experience economic hardship ifbeet processing factories were prevented from purchasing, processing, or selling sugarfrom event H7-1 sugar beets. The sugar beet processing factories would be idled, thousands ofjobs would be lost and the livelihoods of many rural communities would be at stake (USDA FSA, 2010)Dr. Richard Sexton, an agricultural economist and an authority on agricultural cooperatives, recently conducted an investigation as to whatthe economic impactwould be on growers and processors ifthe growing ofGT sugarbeets was enjoined in 2011 and 2012. His results are particularly insightful becausethey rely, in part, on direct interviews and written surveys with each ofthe eight sugarbeet processing companies. Dr Sexton estimated that the consequences on a ban of GTsugarbeets in 2011 are: 1) 8 of21 sugarbeet processing plants would close (and unlikely to reopen); 2) grower crop income would be reduced by approximately $253 million; 3) sugarbeet processor worker salaries would be reduced by about $138 million dollars; and 4) the adverse economic impact on the local economies where sugarbeets are grown and processed would be approximately $1.1 billion. Ifa ban continued through 2012, Dr. Sexton estimated that processorfull-time and seasonal employmentwould be lowered by approximately 1,570 workers, grower incomewould be reduced further by another $282 million and the adverse economic impactwould be $964 million in lower net revenue to growers and their communities (Sexton 2010). Also, a. A 2004 study by the University of Idaho found that ifsugar beet production and processing ceased in Idaho and
Event H7-1 Draft ER 142 Environmental Consequences 7/28/2010alternative crops were planted instead, Idaho would lose over 3,000jobs and farm incomes would decline (given returns to corn, wheat, and other production options based on 2004 projections). Sugar beet growers generally produce other crops, and their land would not remain idle; they havethe equipment and expertiseto produce other crops. The longer-term concern, however, is in terms ofthe impact on infrastructure, as some companies may not survive closing down for one season (USDA FSA, 2010). Additionally, individual sugar cooperative shareholders are significantly penalized for not fulfilling their contract. For example, one cooperative memberstated that, "I currently own 485 shares that are valued at $350 each and I am required to produce485 acres ofsugar beets annuallyto Western for processing. By contract, I am subjectto an economic penalty of$350 per share if my annual share ofsugar beets is not deliveredto Western for processing. Western has enforced this penalty against growers in the past" (Hofer, 2010).



## SugarBeetSeedProduction andAvailability Only sugar beets grown from approved varieties can be utilized by growers for sugar beet production. The processor seed committee will establish a list ofapproved varieties from which growers may select. Once a variety has been approved for commercial production by the processorseed committee, the seed producer produces the seed in the quantities projected to be sold to the processor's growers. Seed suppliers must predict years in advance the likely demand for newvarieties. Ifa seed supplier over predicts likely demand, the excess seed may be inventoried for a period thatdoes not exceed the viability ofthe seed (Manning, 2010). The approved varieties have undergone extensive multi-year planting trials to determine how well each variety tolerates exposureto particular diseases and pests known to infestthe growing region, particular growing conditions such as exposureto particularweather conditions, and thevariety's ability to deliver acceptable yields perton and sugar content (Manning, 2010). The approved variety list denotes sugar beetvarieties that may be delivered to the processorfor sugar production. As a cooperative member, a grower has a contract to deliver sugar beet from a specified number ofacres. Sugar beetvarieties that do not makethe approved variety lists cannot be delivered to the processorfor sugar production because they do not meetthe standards setforth by the processor. A groweris not permitted by the processor to plant a sugar beetvariety not on the approved list (Manning, 2010). Event H7-1 Draft ER 143 Environmental Consequences 7/28/2010When event H7-1 sugar beetwas deregulated in 2005, the industry began production ofevent H7-1 sugar beet seed. The majority ofconventional seed varieties and seed available forthe 2011 crop year originated prior to 2007. Consequently, some approved varieties, including the genetictraits ofthose seed, and the inventory ofsome conventional seed now available were based on production decisions made many years ago (Manning, 2010). Certain seed producers have not engaged in new varietal developmentfor conventional sugar beet since 

### 2006/2007. Some processors have no conventional seed on their current approved variety list, while others still list some conventional seed varieties (Manning, 2010). Manning looked at the availability of sugar beet seed should event H7-1 sugar beet seed be unavailable. Based on Manning's analysis, all sugar beet growing regions in the U.S. would experience a shortfall ofsugar beet seed to plant (Manning, 2010). The USDA FSA (2010) also stated that domestically-produced conventional sugar beet seed is in short supply because domestic seed companies have reduced production ofconventional beet seed in recent years. Sugar beet seed produced outside the United States may not be suitable for commercial production in the U.S. Certain sugar beet seed varieties produced in the European Union (EU) or elsewhere have not undergone extensive multi-yearvariety trials in the U.S to determine if thatvariety meetsthe standards fordisease resistance required by growers and beet processors. The limited availability ofconventional seed could severely restrict plantings ofsugar beets in 2011 and sugar production in 2012 (USDA FSA, 2010). Based on information provided by sugar beet seed producers and buyers, UDSA FSA (2010) estimates that prohibiting the harvest ofevent H7-1 sugar beet seed in 2010, would reduce projected sugar beet root crop acreage by 37 percent in 2011. Based on that estimate, the reduction in acres planted for sugar beet production would lower beet sugar production by an estimated 1.6 million tons in 2012 (lost acreagewith unchanged yields and unchanged sugar recovery)(USDA FSA, 2010). The economic impactofa reduction in beet sugar supply on consumer costs and grower incomes in 2012 would be severe (USDA FSA, 2010). However, the severity would be mitigated depending on the degreeto which sugar users and consumers reduce their consumption ofsugar or switch to non-sugar sweeteners. Manufacturers and consumers will have time to reduce their beet sugar use and manufacturing costs ifa decision to prohibit event H7-1 sugar beets is announced at least ayear before it affects domestic supply. USDA FSA (2010) estimates that U.S. demand for sugar could fall 1 percent due to the higher sugar costs in 2012.

Event H7-1 Draft ER 144 Environmental Consequences 7/28/2010

### Ifevent H7-1 sugar beet seed could not be planted in the spring of2011 to growthe root crop, the 2012 U.S. refined sugar price is expected to rise from 33 cents per pound to 41 cents per pound, which includes transportation, product modification costs necessary to be suitable for American users, and the premium the U.S. Sugar Program provides domestic growers. Sugar users and consumers would pay a total of$1.6 billion additional for sugar in 2012 even ifthey consume less due to the higher sugar prices. Growers and processors are projected to experience a loss of700 million in lost 2012 sugar beet and sugar sales (USDA FSA, 2010). A summary ofthe projected costs from an action that effectively precludes the planting, cultivation, and processing ofevent H7-1 sugar beets on sugar users and consumers and sugar beet growers and processors over the next two years is shown in Table 3-3. 

## HerbicideShortages The availability ofherbicides is anotherfactorthat will likely affect a growers' decision to plant conventional sugar beetvarieties. The advent ofevent H7-1 sugar beets caused a decline in the use ofcertain herbicidesthatwere used with conventional sugar beet crops. The manufacturers ofthese herbicides have reduced production. Should growers plant conventional seed, the herbicides may not be available unless the manufacturers ramp up production to meet anticipated demands. This decision must be madefar in advance ofwhen the herbicides would be needed (Manning, 2010). Table 3-3. Production Loss and ProjectCosts from an event H7-1 Sugar Beet Injunction

Parent Commercial Commercial Harvest! Expected Sugar Costto Costto Seed Seed Seed Sales Sugar Production Growers Users! Planted Produced Planted Year Production Lost Consumers

(1,000 tons) (Million $) lall2008 lal12009 spring 2010 2011 4,477 4,253 3,232 2,972 18112009 fall 2010 spring 2011 2012 4,396 1,627 658 1,592 Source. USDA FSA, 2010



### 3.17 SOCIAL AND ECONOMIC IMPACTS ON RED BEETAND CHARD GROWERS
Seed Production

Event H7-1 Draft ER 145 Environmental Consequences 7/28/2010

### In contrast to the very significant social and economic impacts identified in section 3.16 

### if H7-1 

### sugarbeet cUltivation were halted, the effect of continued cultivation subject to the proposed interim measures would be minimal. As indicated in Section 2.8, most red beet and chard seed crops are grown in areas outside the Willamette Valley in Oregon where the large majority of sugarbeet seed crops are grown. The geographic limitations in the interim measures would preclude H7-1 

### seed cultivation in those areas and remove any chance ofgene transfer between the crops. In the Willamette Valley, there is limited production of red beet and chard seed. See Section 2.8. The majority of such seed producers in those areas have agreed to and comply with the existing Willamette Valley Specialty Seed Association isolation distances for those areas, and have not reported issues or losses dueto genetic transfer. There appears to be only very limited organic red beet and chard seed production in the Willamette Valley, and no indication of genetic transmission in the years since H7-1 

### seed cultivation began on a large scale in 2006. 

### Although one identified organic grower has chosen to grow chard (among other organic crops) in the Western margins of the Valley, that grower has tested his crops on repeated occasions with 

### peR tests over multiple years and found no indication of gene flow from H7-1 

### crops.
In addition, in the years since 2006, 

### seed companies producing H7-1 

### seed in the Willamette Valley have increasingly employed a "gene on the female" nonpollinator approach for H7-1 

### production fields, meaning that those fields shed virtually zero pollen that could transmit H7-1 

### genetic material. As a consequence, as discussed in Section 1.5, 

### even an organic grower who chose to market and sell chard seed with a "zero tolerance" for H7-1 

### genetic material would face no riskfrom such fields.
The organic community's consensus Non-GMO Project Working Standard does not require zero tolerance
- it contemplates a tolerance for GE traits in verified Non-GMO seed or 0.25%. 

### The National Organic Program is a process-based standard; no organic grower has ever lost organic certification due to an unintended trace presence of a GE trait. Further, if an organic grower sensitive to H7-1 

### genetic material wished to ensure "zero tolerance," relatively inexpensive testing is available to do so, and common seed production methodologies can be employed to maintain a "zero tolerance" for organic seed if desired. This is discussed in Sections 1.5 

### and 1.6. 

### There is also no realistic prospect of mechanical mixing between red beet and chard seed

Event H7-1 

### Draft ER 146 Environmental Consequences 7/28/2010

### and H7-1 seed because the two production processes are entirely separate. As discussed in Section 2.7, seed is processed in differentfacilities, and no common equipment is used.
Under APHIS's proposed interim measures, each seed company producing H7-1 would be subject to third party audits of compliance with the standards to ensure that the measures remained in place and were effective. Accordingly, Alternative 2 would have no or negligible social or economic impacts on red beet and chard crops, Alternative 1, by contrast, would have highly significant negative impacts on nationwide sugarbeet production, as discussed above.
Root Crop 

### Production
As indicated above, including in Sections 2.8 there is little or no overlap of H7-1 root crop production and red beet and chard seed production. To the extent certain red beet or chard seed savers may exist in root crop production areas (none have been identified), the measures for roguing bolters and related stewardship render the potential for genetic transmission from H7-1 negligible. As indicated, Alternative 2 would have no or negligible social or economic impacts on red beet and chard crops, By contrast, Alternative 1 would have highly significant impacts across multiple growing areas. Consumer Acceptance of the Sugarfrom Event H7-1 Sugar beets Since wide-scale production of event H7-1 sugar began, there has been no indication of significant concern regarding acceptance of H7-1 sugar producers of food products with sugar derived from these products orfrom consumers. The sugar is identical chemically to sugar from conventional sugarbeets (Baker, 2010a, pp. 2-3; Hoffman, 2010a, p. 10). In addition as indicated in Section 3.11.2, food and feed issues have been reviewed by FDA. This FDA review has not been challenged

For any consumers who are nevertheless concerned about the source ofthis sugar, there are alternatives available. Cane sugar and other sweeteners are readily available for instance. And certain public interest groups, including the Institute for Responsible Technology, have publicized the readily available alternatives to sugarbeet sugar and other sweeteners derived from biotechnology (Burkam, 2010, p. 58).

Event H7-1 

### Draft ER 147 Environmental Consequences 7/28/2010

### CUMULATIVE IMPACTS

This section discussesthe cumulative impacts that may be associated with Alternative 2, when combined with other recent past, present, and reasonably foreseeable future actions within the affected environment. Alternative 

### 2 is expected to be maintained for a short time duration, and an EIS will specifically address the environmental impacts associated with full deregulationin

. Cumulative impacts thatwill occur before the EIS is completed are expected to be negligible. By contrast, as indicated in Section 3.16, the specific and cumulative impacts ofAlternative 1 are expected to be significant for growers nationwide. Cumulative impacts occurwhen the effects ofan action are added to the effects ofother actions occurring in a specific geographic area and timeframe. The cumUlative impact analysis follows CEQ's guidance: Considering Cumulative Effects Underthe National Environmental Policy Act (CEQ, 1997). The steps associated with the analysis include:

• Specifythe class ofactions for which effects are to be analyzed.
• Designatethe appropriatetime and space domain in which the relevant actions occur. • Identify and characterize the set ofreceptors to be assessed.
• Determine the magnitude ofeffects on the receptors and whetherthose effects are accumulating. 

### 4.1 CLASS OF ACTIONS TO BE ANALYZED This analysis addresses large, regional and national-scaletrends and issues that have impacts that may accumulatewith those ofthe proposed interim measures. 

### 4.2 GEOGRAPHIC AND TEMPORAL BOUNDARIES FOR THE ANALYSIS As described in Section 2, over the past 10 years, the number of acres planted annually in sugar beets in the US has ranged from 1.1 to 1.4 million (USDA ERS, 2009, Table 14). Event H7-1 sugar beets are produced in five major regions in the US, and commercial production of seeds takes place in the Willamette Valley of Oregon. Therefore, the spatial domain for past, present, and reasonably foreseeable future actions considers the five growing regions for issues associated with growing event H7-1 sugar beets; the Willamette Valley for issues associated with seed production; and the nation, and in some cases international areas, for issues associated with consumption of sugar beet food and feed products. Also, as indicated, the measures at issuewould apply for a limited time period, estimated at less than 2 years. 

### RESOURCES ANALYZED Issues evaluated in this cumUlative impacts analysis include some ofthe resource areas discussed in Chapters 

### 2 and 

### 3 including land use, air quality and climate, water quality,

Event H7-1 Draft ER 

### 148 Cumulative Impacts 7/28/2010biological, and human health and safety. In addition, specifictopics analyzed include: cumulative impacts related to any possibility ofdevelopmentofglyphosate resistantweeds, and cumulative impacts ofpotential increased glyphosate usagewith the cultivation ofglyphosate tolerant crops. 

### 4.3 

### PARTIAL.CUMULATIVE IMPACTS RELATED TO THE DEVELOPMENT OF GLYPHOSATE RESISTANT WEEDS
Glyphosate offers many benefits to the groweras aweed control product. Glyphosate controls a broad spectrum ofgrass and broadleafweed species present in sugar beet production fields, has flexible usetimings, and when used in glyphosate-tolerantcrops, has a very high level of crop safety (see petition 03-323-01 p, Tables VII-4 and VII-4, pages 90 and 92, respectively). As the adoption ofglyphosate-tolerant crops has grown, the use ofglyphosate has increased over the pastseveral years. With the increased use ofglyphosate, there is also the potential for increased selection pressure forthe development ofglyphosate-resistantweeds (Section VIII). Because a glyphosate-based herbicide program is currently being used with event H7-1 sugar beet, glyphosate use for event H7-1 is not expected to increase beyond current levels, as market penetration is already at 95 percent. Current levels ofglyphosate use in event H7-1 sugar beets are a minor (approximately 0.7 percent) amount oftotal US glyphosate use. Additionally, with Alternative 2, growers still would have the currently available weed control tools (e.g., non-glyposate herbicides and cultural practices described in Section VII.B of petition 03-323-01p on page 88) needed on a small scaleto manage any glyphosate-resistantweeds, whetherthey are present in sugar beet or other crop production fields.



### 4.4 

### CUMULATIVE IMPACTS OF POTENTIAL INCREASED GLYPHOSATE USAGE WITH THE CULTIVATION OF GLYPHOSATE TOLERANT CROPS Studies ofthe relationship between genetically engineered crops and herbicide use has shown that an increase in glyphosatetolerant crops can result in a decrease in mechanical tillage (Brimner et aI., 2005; Fernandez-Cornejo, 2006; Gianessi and Reigner, 2006; Kleter et. aI., 2007; Sankula, 2006; Johnson etaI., 2008). The potential cumulative impactfrom this reduction in mechanical tillage is discussed in the following sections.

Event H7-1 Draft ER 149 Cumulative Impacts 7/28/2010

### According to the USDA ERS (2009), US farmers have adopted genetically engineered crops widely since their introduction in 1996. Soybeans and cotton genetically engineered with herbicide-toleranttraits have been the mostwidely and rapidly adopted GE crops in the US, followed by insect-resistant cotton and corn. Figure 4-1 shows the percentage ofacres of genetically engineered crops in the US between 1996 and 2009.

Percent ofaCf8S 100,----------------------------------------------,

80 .." HT Cotton
60 '0' Bt 

### Cotton

40

20**D1L--.--'--'--.---r--.--'---'--.--.--'--.--~**

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2DD8 2009 Datafor eaell crop category include varieti{}s with both HT and Bt (stacked)trailS. Sources: 1996·199!ldata aro from Fornandoz·Cornejo and McBride {ZOGl).1 

### I Figure 4-1 Growth in Adoption ofGenetically Engineered Crops in US Source: Graph from USDA ERS, 2009



### Herbicide-tolerant crops, which are engineered to survive application ofspecific herbicides that previously would have damaged the crop, provide farmers with a broadervariety ofoptions for effective weed control. Based on USDA survey data, herbicidetolerant soybeans wentfrom 17 percent of US soybean acreage in 1997, to 68 percent in 2001 and 91 percent in 2009. Plantings ofherbicidetolerant cotton expanded from approximately 10 percent of US acreage in 1997to 56 percent in 2001 and 71 percent in 2009. The adoption ofherbicide tolerant corn, was slower in previous years, but has reached 68 percent ofUS corn acreage in 2009 (USDA ERS, 2009). Corn growers use the largestvolume ofherbicides. Approximately 96 percent ofthe 62.2 million acres used for growing corn in the 10 major corn-producing States were treated with
Event H7-1 

### Draft ER 150 Cumulative Impacts 7/28/2010morethan 164 million pounds ofherbicides in 1997 (USDA ERS, 2009). Soybean production in the US also uses a large amount ofherbicides. Approximately 97 percent ofthe 66.2 million soybean acres in the 19 major soybean producing States were treated with morethan 78 million pounds ofherbicides in 1997 (USDA ERS, 2009). Cotton production relies heavily on herbicidesto control weeds, often requiring applications oftwo or more herbicides at planting and postemergence herbicides later 

### in the season (Culpepper and York, 1998). Close to 28 million pounds ofherbicides were applied to 97 percent ofthe 13 million acres devoted to upland cotton production 

### in the 12 major cotton-producing States 

### in 1997 (USDA ERS, 2009). Pesticide use on corn and soybeans has declined since the introduction ofGE corn and soybeans 

### in 1996. Several studies have analyzed the agronomic, environrnental, and econornic effects ofadopting GE crops, including actual pesticide use changes associated with growing GE crops (McBride and Brooks, 2000; Fernandez-Cornejo, Klotz-Ingrarn, and Jans, 1999,2002; Giannessi and Carpenter, 1999; Culpepper and York, 1998; Marra et aI., 1998; Falck-Zepeda and Traxler, 1998; Fernandez-Cornejo and Klotz-Ingram, 1998; Gibson etaI., 1997; ReJesus et aI., 1997; Stark, 1997). Many ofthese studies have concluded that herbicide use is reduced with herbicide-tolerantvarieties (USDA ERS, 2009). Studies conducted by the USDA also show an overall reduction 

### in pesticide use related to the increased adoption ofGE crops. Based on the adoption ofGE crops between 1997 and 1998 (exceptfor herbicide-tolerant corn, which is modeled for 1996-97), the decline 

### in pesticide use was estimated to be 19.1 million acre-treatments, 6.2 percent oftotal treatments (USDA ERS, 2009). Mostofthe decline 

### in pesticide acre treatments was from less herbicide used on soybeans, accounting for morethan 80 percent ofthe reduction (16 million acre-treatments) (USDA ERS, 2009). The adoption of herbicide-tolerant crops such as event H7-1 sugar beets, glyphosate-tolerant soybeans, and glyphosate-tolerant corn results in the substitution ofglyphosatefor previously used herbicides. The glyphosatetolerant crops allow farmers to limit and Simplify herbicide treatments based around use ofglyphosate, while a conventional weed control program can involve multiple applications ofseveral herbicides. 

### In addition, and more importantly, herbicidetolerant crops often allow farmers to use more benign herbicides (USDA ERS, 2009). There are known benefits associated with the use ofglyphosate herbicides compared to herbicides currently used by sugar beet producers. Glyphosate has documented favorable characteristics with regard to risk to human health, non-target species, and the environment
Event H7-1 Draft ER 151 Cumulative Impacts 7/28/2010(Malik et aI., 1989; Geisy et aI., 2000; Williams etaI., 2000). Glyphosate is classified bythe EPA as a Group E pesticide (evidence ofnon-carcinogenicityfor humans) (57 FR 8739). In 1998, the EPA granted Reduced Risk statusfor an expedited review ofthe submitted residue data package supporting the use ofglyphosate, as Roundup Ultra herbicide (EPA Registration No. 524-475) for use in glyphosatetolerant sugar beets. Reduced Risk statuswas granted by EPA based on a detailed hazard comparison ofglyphosateto alternative herbicides available for weed control in sugar beet production (Reduced Risk petition document: MRID44560501), and an overall conclusion thatweed control with Roundup Ultra herbicide offers a substantial benefit to sugar beet growers in theform of reduced risk to human health, non-targetspecies, and the environment.
4.4.1 Land Use, Air Quality and Climate As discussed in Section 3, sugar beet acreage has fluctuated little forthe past 50 years, was not impacted bythe introduction ofevent H7-1, and is notexpected to be impacted by continued use ofevent H7-1. Therefore, as discussed in Section 3, Alternative 2 is notexpected to impact land use. As it is notexpected to directly or indirectly impact land use, Alternative 

### 2 would not have cumulative impacts on land use. As discussed in Section 3, Alternative 2 is expected to continue to have small positive impacts on airquality and climate, primarily resulting from reduced tillage. Consequently, Alternative 

### 2 is notexpected to have any adverse cumulative impacts on airquality or climate.
4.4.2 Water Quality As discussed in Section 3, the adventofglyphosate tolerant crops and the use ofpost-emergent herbicides that could be applied overa crop during the growing season have facilitated the use ofconservation tillage farming practices, sinceweeds could be controlled aftercrop growth withouttilling the soil (USDA ERS, 2009). The use ofglyphosate tolerant crops (particularly soybeans) has intensified thattrend since it often allows a more effective and less costly weed control regime than using other post-emergent herbicides (USDA ERS, 2009; Carpenter and Gianessi, 1999).
The impactofconservation tillage (including no-till, ridge-till, and mulch-till) in controlling soil erosion and soil degradation is well documented (Edwards, 1995; Sandretto, 1997). By leaving substantial amounts ofplant matter overthe soil surface, conservation tillage 1) reduces soil erosion by wind; 2) reduces soil erosion bywater; 3) increaseswater infiltration and moisture

Event H7-1 Draft ER 152 Cumulative Impacts 7/28/2010

### retention; 4) reduces surface sediment and water runoff; and 5) reduces chemical runoff (USDA ERS, 2009). Glyphosate maypotentially be found in surface water runoffwhen erosion conditions lead to the loss ofsurface particles. However, as discussed in Section 3, partial deregulation ofglyphosate tolerant crops typically leads to an increase in conservation tillage and no tillage systems, which would result in less mechanical disturbance ofthe soil during sugar beet cUltivation and thereby decreasethe loss ofsurface soil. Because ofthis, and the fact that glyphosate binds strongly to soil particles, no-tillage and conservation tillage are expected to further reduce the likelihood of any impactsurface water runoff (Wiebe and Gollehon, 2006). Therefore, no cumulative adverse impacts to surface water or groundwater are anticipated. 4.4.3 Biological For non-targetterrestrial species, available ecological assessments in EPA RED (EPA, 2003) documents or registration review summary documents provide the support thatthe use of glyphosate represents reductions in chronic risk to birds compared to trifluralin and sethoxydim, in acute risk to small mammals in comparison to EPTC, in chronic risk to mammals from quizalofop-p-ethyl, in acute risk to endangered birds and mammals from pyrazon, and in chronic risk to mammals and potentially birds from cycloate. Forall other sugar beet herbicide products, as well as glyphosate, no significant risks to birds orother non-targetterrestrial species were indicated in the available information. For non-target aquatic species, Tables 4-1, 4-2, and 4-3 provide summaries ofthe estimated exposure and hazard information for thetraditional herbicides used in conventional sugar beet production, and present quantitative comparisons ofthe derived Risk Quotients. Exposure, defined as the EEC, was calculated for all products using the standard assumptions (assuming aerial application) of5 percent driftofspray applied to a one-acre field onto water and 5 percent runofffrom 10 treated acres into aone-acre pond six feet in depth. Herbicide treatments were based on the maximum single application rate taken from product labels. Hazard information (LC50 or EC50) for each active ingredientwas taken from the EPA Ecotoxicology One-Liner Database (ifavailable) or other EPA source documents and summarized in Tables 4-1,4-2 , and 4-3 as the upper and lowervalues from the range ofvalues reported. Hazard information forthe end-use formulated products is generally not readily available, thus this analysis is a comparison based solely on the active ingredients. Any label warnings and other available hazard andlor risk descriptionsfor non-target aquatic species are also included. The Risk

Event H7-1 Draft ER 153 Cumulative Impacts 7/28/2010Quotient is determined for each active ingredient by dividing the EEC by the hazard (LC50 or EC50) value. Plants potentially at risk from the use ofglyphosate are potentially at risk from the use ofany herbicide. Like most herbicides, plants are highly sensitive to glyphosate. Monsanto has developed a program named Pre-Serve to address aerial spraying in areas where threatened plants may be located. Following label use instructions and use limitations described in PreServe swould address any such risk ofexposure. Federal law requires pesticides to be used in accordance with the label.. Because glyphosate binds strongly to soil particles, conservation tillage and no tillage practices provide additional assurance that the impactto aquatic plants through decreasing soil-laden runoffare negligible. The labels for products containing desmedipham, phenmedipham, sethoxydim, clethodim and trifluralin includewarnings oftoxicity or adverse effects to fish, and/or aquatic invertebrates and/or aquatic plants. Risk Quotients that exceed the Trigger Value of0.5 for aquatic animals and 1.0for aquatic plants are highlighted in bold text in Tables 4-1, 4-2, and 4-3 as exceeding a Level ofConcern, based on EPA Ecological Effects Rejection Analysis and Deterministic Risk Characterization Approach. Current sugar beet herbicide products containing triflusulfuron, trifluralin, and pyrazon are shown to exceed these Levels ofConcernAs supported by the EPA designation of reduced risk for application ofglyphosate to H7-1 sugar beet,. glyphosate is a more environmentally preferred herbicide compared to other herbicides currently used in sugar beet production since glyphosate is generally lesstoxic and has favorable degradation properties.
4.4.4 Human Health and Safety A tolerance increase was required to support approval for the use ofglyphosate in the event H7- 1sugar beet-cropping system compared to the limited pre-emergent use ofglyphosate in conventional sugar beet production. However, the potential health effects ofpesticide residues that may be present in food, regardless ofwhetherthey result from uses in conventional or glyphosatetolerant crops, are carefully considered by EPA before establishing maximum residue limits ortolerances. Before establishing a tolerance in an agricultural commodity, EPA mustfind that the potential resulting residues covered by the proposed tolerancewill be "safe". Section 408(b)(2)(A)(ii) of the FFDCA [21 USC 346a(b)(2)(A)(i)] defines "safe" as a reasonable certaintythat no harm will resultfrom aggregate exposureto the pesticide chemical residue. As part ofthis determination,
Event H7-1 Draft ER 154 Cumulative Impacts 7/28/2010the total maximum theoretical level ofresidue present in all food commodities with approved uses forthe pesticide must not exceed the EPA established Reference Dose (RfD), or chronic Population Adjusted Dose (cPAD). Following a comprehensive review ofthe results of toxicological studies conducted on the pesticide, the RfD is set by applying appropriate uncertaintyfactors to the most appropriate No-Observed-Adverse-Effect-Level (NOAEL). 

### In 1999, EPA conducted a dietary exposure risk assessment and concluded thatthe incremental dietary exposure associated with the use ofglyphosate on glyphosatetolerant sugar beet did not pose a concern to human health (64 FR 18360, 1999).

Event H7-1 Draft ER 

### 155 Cumulative Impacts 7/28/2010Table 4-1 Comparison of Potential Effects ofGlyphosateand Sugar Beet Herbicides on Freshwater Fish Fish LC60 (a.i.)' Fish Risk Quotient' Active Ingredient Max. Ib/acre EEC' Range Range Classification 1Label (single appl.) (ppm) (ppm) Warnings

. low high worst best Glyphosate 1.125 0.038 45 140 0.0008 0.0003 .Clethodim 0.09 0.003 19 >33 0.0002 <0.0001 Clopyralid 0.25 0.008 104 125 0.0001 0.0001 Cycloate 4.0 0.135 4.5 7 0.03 0.02 Desmedipham 1.2 0.040 1.7 6 0.024 0.007 Toxic to fish. 

### I EPTC 4.2 0.142 11.5 27 0.012 0.005 Ethofumesate 3.6 0.121 0.75 >320 0.16 <0.0004 Phenmedipham 0.6 0.020 1.41 3.98 0.014 0.005 Pyrazon 7.3 0.246 NA NA NA NA Quizalofop-p-ethyl 0.17 0.006 0.17 10.72 0.034 0.00 Sethoxydim 0.47 0.016 170 265 0.0001 0.0001 Toxic to aquatic organisms. h-rifluralin4 0.72 0.024 0.0084 0.210 

### 2.9 0.12 Extremely toxic to freshwater, marine and estuarine fish. h-riflusulfuron 0.08 0.0027 <640 <760 >0.000004 >0.000004 NA 

### = information not available 1 EEC refers to the Estimated Environmental Concentration l which assumes that a one-acre pond, six feet deep receives 5% drift from a aneacre field and 5% runofffrom a 10-acre field. 2 Aquatic LCso values obtained from the 2010 EPA Ecotoxicology One-Liner Database. 3 Risk Quotient is EEC/LCso. Risk Quotient Balded if > 0.5 = Level of Concern [criteria from EPA Ecological Effects, Rejection Analysis]. Risk Quotients >0.1 result in classification for Restricted Use (http://www.epa.gov/oppefed1/ecorisk_ders/toera_risk.htm#Deterministic). 4 Toxicity values are from the Trifluralin Reregistration Eligibility Document, United States Environmental Protection Agency, April 1996.

Event H7-1 Draft ER 156 Cumulative Impacts 7/28/2010Table 4-2 Comparison of Potential Effects ofGlyphosate and Sugar Beet Herbicides on Freshwater Aquatic Invertebrates Max. Iblacre EEC' Invertebrate EC" (a.i.)2 Invertebrate Risk Classification I Label Range Quotient' Warnings Active Ingredient (single appl,) (ppm) (ppm) Range low high worst best Glyphosate 1.125 0.038 134 780 0.0003 0.00005 Clethodim4 0.09 0.003 20.2 

### NA 0.0002 

### NA Clopyralid 0.25 0.008 225 

### NA 0.00004 

### NA Cycloate 4.0 0.135 2.6 24 0.052 0.006 Desmedipham 1.2 0.040 1.88 

### NA 0.021 

### NA EPTC 4.2 0.142 3.5 66 0.040 0.002 Ethofumesate 3.6 0.121 64 294 0.002 0.0004 Phenmedipham 0.6 0.020 3.2 14 0.006 0.001 Toxic to fish and aquaticorganisms. Pyrazon 7.3 0.246 

### NA NA NA NA Quizalofop-p-ethyl 0.17 0.006 2.12 6.4 0.003 0.001 Sethoxydim 0.47 0.016 78 

### NA 0.0002 

### NA Toxicto aquatic organisms. Irrifluralin' 0.72 0.024 0.56 2.2 0.043 0.011 Ex1remely toxic to aquati invertebrates. Triflusulfuron 0.08 0.0027 960 

### NA 0.000003 

### NA I NA = information not available or not applicable 1 EEC refers to the Estimated Environmental Concentration, which assumes that a one-acre pond, six feet deep receives 5% drift from a one-acre field and 5% runofffrom a 10-acre field. 2 Aquatic Invertebrate ECso values obtained from the 2010 EPA Ecotoxicology One-Liner Database. 3 Risk Quotient is EECIECso. Risk Quotient Balded if> 0.5 = Level of Concern [criteria from EPA Ecological Effects, Rejection Analysis] 4 EC50 value is from a study using a 25.6% ai concentration. s Toxicity values are from the Trinuralin Reregistration Eligibility Document. United States Environmental Protection Agency, April 1996.

Event H7-1 Draft ER 157 Cumulative Impacts 7128/2010Table 4-3 Comparison of Potential Effects ofGlyphosate and Sugar Beet Herbicides on Aquatic Plants (Algae and Duckweed) Max. Iblacre EEC' Aquatic Plant EC50 (a.i.)' Aquatic Plant Risk Classification 1Label Range Quotient' Warnings Active Ingredient (single appl.) (ppm) (ppm) Range low high worst best Glyphosate 1.125 0.038 0.8 38.6 0.047 0.001 Clethodim 0.09 0.003 1.34 >11.4 0.0023 <0.0003 May pose hazard to federally listed endangered plants. Clopyralid 0.25 0.008 6.9 NA 0.001 NA Cycloate 4.0 0.134 NA NA NA NA Desmedipham 1.2 0.040 0.044 >0.33 0.909 <0.123 EPTC 4.2 0.141 1.36 41 0.104 0.003 Etholumesate 3.6 0.121 >2.76 >39 <0.044 <0.003 Phenmedipham 0.6 0.020 0.19 >0.32 0.106 <0.064 Toxicto aquatic organisms. Pyrazon 7.3 0.245 0.17 >4.6 1.441 <0.053 Quizalolop-p-ethyl 0.17 0.006 >0.082 >1.77 <0.069 <0.004 Sethoxydim 0.47 0.016 >0.27 >5.6 <0.059 <0.003 Toxicto aquatic organisms. Trifluralin 0.72 0.024 0.015 5.0 1.60 0.005 Extremely toxic to aquatic invertebrates. Irrillusulfuron4 0.08 0.0027 0.0028 0.123 0.96 0.022 

# J , . - NA = information not available or not applicable. 1 EEC refers to the Estimated Environmental Concentration, which that a one-acre pond, six feet deep receives 5% drift from a one-acre field and 5% runoff from a 10-acre field. 2 Aquatic EC5G values obtained from the 2010 EPA Ecotoxicology One-Liner Database except for the values for phenmedipham which are from the Reregistraflon Eligibility Decision lor Phenmedipham

.. 3 Risk Quotient is EEC/EC50. Risk Quotient Balded if> 1.0 = Level ofConcern [criteria from EPA Ecological Effects. Rejection Analysis]. 4 Toxicity values are from the Regulatory Note REG99-03 from the Pest Management Regulatory Agency ofCanada.

Event H7-1 Draft ER 158 Cumulative Impacts 7/28/2010In a recent risk assessment supporting establishment ofcertain newfood crop tolerances for glyphosate, EPA estimated that chronic (daily dietary) exposure to glyphosate from all food and water sources would use only 2 percent ofthe glyphosate RfD (1.75 mg/kg/day) forthe general US population and 7 percent ofthe RfD forthe highest potentially exposed subgroup population (71 FR 76180, 2006).

The cumulative impactsfrom use ofglyphosate on sugar beets was considered. , Biomonitoring ofpesticide applicators conducted by independent investigators has shown that bodily adsorption ofglyphosate as the result ofroutine, labeled applications of registered glyphosate-based agricultural herbicidesto crops, including to glyphosatetolerant sugar beet, was thousands oftimes less than the allowable daily intake level established for glyphosate (Acquavella et aI., 2004). Given similarity to current use pattern, herbicide label rates, and the percentage ofcultivate acres for sugar beets, the continued use ofevent H7-1 sugar beet through partial deregulation will notsignificantly increasethe exposure risk to pesticide applicators. Furthermore, EPA, the European Commission, the WHO, and independent scientists have concluded thatglyphosate is not mutagenic or carcinogenic, nota teratogen nor a reproductive toxicant, and that there is no evidence ofneurotoxicity associated with glyphosate (EPA, 1993; EC, 2002; WHO, 2004, and Williams et aI., 2000). Bystander exposureto glyphosate as a result ofpesticide application to event H7-1 sugar beet would be negligible, since such applications would occur in an agricultural setting in relatively rural sugar beetfields, not in an urban setting. Presented below is an brief, comparative analysis ofthe hazard/risk characteristics of glyphosate, the active ingredient in Roundup WeatherMAX@ herbicide (EPA Registration No. 524-537), to the most commonly used herbicides applied in conventional sugar beet production, based on total pounds ofactive ingredient applied (USDA-NASS, 2001). A detailed assessment ofthe potential chronic human health risks compared to traditional products will not be presented in this comparison. The assessment is based on information obtained from various sources, including product-specific labeling, EPA Reregistration Eligibility Documents (RED, EPA, 1993), EPA RED Fact Sheets, product-specific Federal Register publications, the EPA

® Roundup UltraMAX is a registered trademark ofMonsanto Technology LLC Event H7-1 Draft ER 159 Cumulative Impacts 7/28/2010

### Ecotoxicology One-Liner database42,the USDA Pesticide Properties database43, and other public sources ofproduct-specific toxicological and environmental profile information. The assessment shows that in the majority of cases, weed control with glyphosate, formulated and sold as Roundup WeatherMAX herbicide, in the event H7-1 sugar beet system offers the benefit of less riskfrom potential exposure for applicators and handlers ofconcentrated product and a reduced potential to impact non-target species and water quality.

Table

### 4-4 provides a comparison of product-specific labeling for herbicides commonly used for weed control in sugar beet production, including required precautionary statements associated with acute exposure hazards and environmental risk concerns. Although most alternative products carry the same signal word as Roundup WeatherMAX herbicide (CAUTION), the associated precautionary statements ofeach ofthe alternative herbicide products are indicative oftoxicity findings that represent a greater acute exposure risk than Roundup WeatherMAX. Nearly every sugar beet herbicide product evaluated has more restrictive requirements for the use of Personal Protective Equipment (PPE) than those required for Roundup WeatherMAX herbicide, indicating a greater need to reduce the risk ofacute exposure, and, in some cases, the risk oflonger-term orchronic exposure, forapplicators and handlers ofthese other products. The comparative analyses provided in this section are summarized in Table

### 4-5 and showthose areas forwhich glyphosate (designated with a checkmark v'), 

### using Roundup WeatherMAX herbicide in the comparison, offers the benefit ofpotential risk reduction compared to the most commonly used sugar beet herbicides in sugar beet production. In this cumulative comparison, glyphosate offers potential benefits over all the traditional sugar beet herbicides in at least one and up to four risk assessment categories. These comparisons demonstratethe benefits to applicators, mixers and non-target organisms from the use ofglyphosate in the event H7-1 sugar beet system. 

### 4.4.5 Summary of Potential Cumulative Impacts from Increased Use ofGlyphosate When conSidering the impactthatthe use ofglyphosate in the event H7-1 sugar beet system could have on the human environment in conjunction with the use ofglyphosate in other glyphosate tolerant crops already being cultivated in the same affected environments, the facts suggestthatthis use will have little or noadditive effect Additionally, use ofglyphosate.

42 EPA Ecotoxicology One-Linerdatabase: http://www.ipmcenters.org/Ecotoxlindex.cfm 43 USDA Pesticide Properties database: ttp:/Iwww.ars.usda.gov/Services/docs.htm?docid=14199 

### Event H7-1 Draft ER 160 

### Cumulative Impacts 7/28/2010Alternatively, this hasthe potential to reduce risks to the affected environmentfrom the use of other, more harmful, herbicides. This is supported bythe assessment ofthe environmental and worker safety hazards associated with glyphosatewhen compared to other available herbicides used forweed control in sugar beet production. Based on such an assessment, EPA granted reduced risk status forthis use ofglyphosate, and expedited the review ofsupporting residue data. Therefore, there is no reasonably anticipated adverse cumulative impacton human health orthe environmentfrom the use ofglyphosate associated specifically with the deregulation of event H7-1 sugar beets For a discussion ofcoexistence of H7-1 and conventional beta species crops, see Sections 1.6 and 2.4..

Event H7-1 Draft ER 161 Cumulative Impacts 7/28/2010Active Ingredient(s) Glyphosate

Clethodim'

Clopyralid

Event H7-1 Draft ER Table 44 Alternative HerbicidesforWeed Control in Sugar Beets
- Label Comparison / Exposure Mitigation Max. Ib Label Sugar Beet ai/acre Max. lb. Product Signal PHI' (single ai/acre

Brand Word (days) appl.) (season) Roundup Caution 30 1.125 6 WeatherM AX

Select 2 Warning 40 0.09 0.25

EC or Prisim

Stinger Caution 45 0.25 0.25

162 Label Precautionary Statements / Special Directions/ Other Information Causes moderate eye irritation. Harmful ifinhaled. Do not store in steel. Four resistant weed biotypes confirmed to date.

Causes substantial, buttemporary, eye injury. Harmful if swallowed or inhaled. Potential skin sensitizer. Warnings and precautions for runoff and drift. Use ofthe product may pose hazard to federally listed endangered plant species. Warnings for repeated use leading to selection of resistant weed biotypes. Crop injurywarnings. Causes eye injury. Harmful if inhaled or absorbed through skin. Warning for leaching to groundwater under certain conditions. Crop injury warnings for 1) use oftreated plant material or manure from animals grazed in treated areas, as mulch or compost; and 2) spreading of treated soil. Up to 18-month rotation restrictions to many crops due to risk of injury; field bioassay recommended. -_
.. Applicatorand Handler PPEb Required to Mitigate Exposure Risks Long-sleeved shirt, long pants, shoes plus socks. When handling this concentrated product or its application solutions of30% or greater, must also wear chemicalresistant gloves. Long-sleeved shirt, long pants, shoes plus socks, chemicalresistant gloves, protective eyewear. Do not reuse heavily contaminated clothing.

Long-sleeved shirt, long pants, waterproofgloves, shoes plus socks.

-

Cumulative Impacts 7/28/2010Table 44 Alternative Herbicides for Weed Control in Sugar Beets - Label Comparison / Exposure Mitigation

Active Ingredient(s)

Cycloate

Desmediphamd

L.

__

Event H7-1 Draft ER - Product Brand Ro-neet

Betanex

'---

- 

## , Max. Ib Label Sugar Beet ai/acre Signal PHI' (single Word (days) appl.) Caution NA; preplant 

### 4 incorporation

Caution 75 1.2

- Max. lb. Label Precautionary Statements ai/acre / Special Directions/ Other (season) Information 4 Harmful if swallowed. Avoid contamination offood orfeed. Soil incorporation or soil injection required. Crop injury concerns dependent on soil type.

1.92 Harmful ifswallowed. Causes moderate eye irritation. Prolonged orfrequent repeated skin contact may cause allergic reaction. This product contains the toxic inert ingredient isophorone. This product is toxic to fish. Do not apply where runoff is likelyto occur. Sugar beet injury possible under many situations.

163 Applicator and Handler PPEb Required to Mitigate Exposure Risks Long-sleeved shirt. long pants. chemical-resistant gloves, shoes plus socks. Added PPE in California fora non-closed system; for mixers/loaders: chemical resistant clothing, full face respirator; for applicators: coveralls, plus half-face respirator, 93 gallon limitfor 21-day period. Long-sleeved shirt, long pants, chemical-resistant gloves, shoes plus socks, protective eyewear.

I

Cumulative Impacts 7/28/2010Table4-4 Alternative HerbicidesforWeed Control in Sugar Beets
- Label Comparison I Exposure Mitigation

Active Ingredient(s) Desmediphaml phenmedipham

EPTC'

Ethofumesate

Event H7-1 Draft ER Product Brand Betamix

Eptam

Nortron Label Signal Word Warning

Caution

Caution Max. Ib Sugar Beet ailacre PHI' (single (days) appl.)

75 1.2

NA; preplant 4.2 incorporation orvery early postemergen ce 90 3.6 Max. lb. Label Precautionary Statements ailacre I Special Directions IOther (season) Information 1.92 Causes substantial, but temporary, eye injury. Harmful ifswallowed or absorbed through skin. This product contains the toxic inert ingredient isophorone. This product is toxic to fish and aquatic organisms. Drift and runoff

...may be hazardous to fish and aquatic organisms. Physical hazard: Combustible. Sugar beet injury possible under many situations; evening applications recommended. Rotation restriction of 120 days for cereals. 5.6 Harmful ifswallowed. Avoid breathing spray mist. Incorporation or soil injection required unless applied through irrigation. 4 Harmful ifswallowed, inhaled or absorbed through skin. Rotation restrictions of6to 12 months for crops otherthan sugar beets or ryegrass. Do not graze livestock on treated crops.

164 Applicatorand HandlerPPEb Required to Mitigate Exposure Risks Long-sleeved shirt, long pants, chemical-resistant gloves, shoes plus socks, protective eyewear.

Long-sleeved shirt, long pants, chemical-resistant gloves, shoes plus socks.
Long-sleeved shirt, long pants, waterproofgloves, shoes plus socks.

Cumulative Impacts 7/28/2010Active Ingredient(s) Pyrazon

Quizalofop-pethyl

Sethoxydim'

Event H7-1 Draft ER Table4-4 Alternative HerbicidesforWeed Control in Sugar Beets
- Label Comparison 1Exposure Mitigation Max.lb Label Sugar Beet ai/acre

.. Max. lb. Product Signal PHI' (single ai/acre

Brand Word (days) appl.) (season) pyramix DF Caution 0 7.3 7.3

Assure II Danger 45 days, 0.17 0.17 except 60 days for feeding of tops

Poast Warning 60 0.40 0.8

165 Label Precautionary Statements 1Special Directions 1Other Information Harmful ifswallowed, inhaled or absorbed through skin. Avoid breathing dust orspray mist. Causes moderate eye irritation. Significant crop injurywarning statements, depending on soil moisture level, soil type (organic mattercontent, loam, sandy, etc.), and temperature attime of application, application method, and tank mix products. Causes severe eye irritation. May irritate skin, nose and throat. May be harmful ifabsorbed through skin, swallowed or inhaled. This product contains petroleum-based distallates. Rotation restriction of 120 days for crops not labeled. Need spray adjuvant added. Causes substantial, buttemporary, eye injury. Harmful ifswallowed. This product is toxic to aquatic organisms. Crop injury warnings. Multiple confirmed resistant weed biotypes. Applicatorand Handler PPEb Required to Mitigate Exposure Risks Long-sleeved shirt, long pants, chemical-resistant gloves, shoes plus socks. Do not reuse clothing heavily contaminated with this product's concentrate.

Long-sleeved shirt, long pants, chemical-resistant gloves, shoes plus sock, protective eyewear. Do not reuse clothing heavily contaminated with this product's concentrate.

Coveralls over short-sleeved shirt and short pants, chemical-resistant! gloves, chemical-resistant I footwear, protective eyewear, chemical-resistant headgearfor overhead exposure, chemicalresistant apron for cleaning, mixing, loading.

Cumulative Impacts 7/28/2010Table4-4 Alternative HerbicidesforWeed Control in Sugar Beets
- Label Comparison 1Exposure Mitigation 

### Max.lb Label Sugar Beet ai/acre Max. lb. Label Precautionary Statements Applicatorand Handler PPEb Active Product Signal PHI' (single ai/acre 1Special Directions 1Other Required to Mitigate Exposure Ingredient(s) Brand Word (days) appl.) (season) Information Risks h"rifluralin9 Treflan Caution NA; one 0,72 4.0 Causes moderate eye irritation, Long-sleeved shirt, long pants, HFP application harmful if swallowed, potential skin shoes plus socks, chemicalbetween first sensitizer. This product contains resistant gloves, protective true leafand aromatic hydrocarbon and can be eyewear, Do not reuse clothing 6 inch stage extremely toxic ifswallowed, This heavily contaminated with this pesticide is extremely toxic to product's concentrate, freshwater marine and estuarine fish and aquatic invertebrates, Soil incorporation required within 24 hrs ofapplication, Crop injury warnings. Crop rotation restrictions ranging from 5to 21 months, Confirmed multiple resistant weed biotypes,**~riflusulfuron** Upbeet Caution 60 0,008 0,08 Resistant weed biotypes; multiple Long-sleeved shirt, long pants, MOA resistance, Need spray chemical-resistant gloves, shoes I adjuvant added. plus socks, NA indicates not applicable,

, PHI- Post Harvest Interval.

PPE - Personal Protective Equipment.

, Based on recent clethodim tolerance action (67 FR 46893, Final Rule, July 17, 2002) percent-crap-treated market data necessary to refine chronic dietary

exposure estimates; per label statement: concern for risks to endangered plant species. d 1996 desmedipham RED: concern for Margins of Exposure (MOE) for dermal exposure to miXers and loaders; additional concern for applicator inhalation

exposure to wettable-powder formulations requiring limits on application rate per acre and number ofacres treated per day; lowto moderate chronic risk to birds.

, 1999 EPTC RED; 10x FOPA UF retained due to neurotoxic effects; developmental neurotoxicity study required; reversible Cholinesterase inhibitor; Tier 3

refinements using average residues and percent crop treated data for chranic dietary assessment; concern for risk to applicators and handlers fram dermal and inhalation exposure; concern for risks to small mammals and non-target plants, including endangered species from run-off and spray drift. f Based on recent sethoxydim tolerance actions (66 FR 51587, Final Rule, Oct.10, 2001), aPAD includes additional 3x FOPA UF for acute exposure to females 13+ yrs of age, due to fetal effects seen in rat developmental tox study; antiCipated residues and percent-crap-treated data necessary to refine chronic exposure assessment. 9 1995 Trifluralin RED: concern for cancer risk to applicators, handlers and field workers; moderately to highly toxic to fish and aquatic invertebrates; chronic risk

concern for birds due to evidence of egg cracking in avian study.

Event H7-1 Draft ER 166 Cumulative Impacts 7/28/2010Table4·5 Potential Reduction in Riskfrom Use ofGlyphosate Compared toTraditional Herbicides Used in US Sugar Beet Production

Active Human Health Risk Non·Target Species Risks Groundwater Ingredients1 Contamination Aquatic Aquatic Acute Chronic Mammals Fish Invertebrates Plants Avian Clethodim 

### or or or Clopyralid 

### or or Cycloate 

### or or or or Desmedipham 

### or or or EPTC 

### or or or or Ethofumesate 

### or or or Phenmedipham 

### or Pyrazon 

### or or or or or Quizalofop·p· 

### or or or ethyl Sethoxydim 

# '" '" or Trifluralin 

# '" 

# '" '" or 

# '" or Triflusulfuron 

# '"
1 Traditional herbicides are compared to glyphosate, using the label from Roundup WeatherMAX herbicide

. ./ Indicates there is a potential for reduction in risk category by using Roundup agricultural herbicides.

Event H7·1 Draft ER 167 Total NumberofAreas I for Potential Risk Reduction 3 2 

### 4 3 

### 4 3 1 5 3 

### 3 6 

### 1

Cumulative Impacts 7/28/2010

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### References 7/28/2010Sadava, 2008. David Sadava. Understanding genetics: DNA, genes, and their real-world applications. TheTeaching Company. Sandretto, C. 1997. "Crop Residue Management," AgriculturalResources andEnvironmental Indicators, AH-712, pp. 155-174. USDA, Economic Research Service. Sankula, S. 2006. "Quantification ofthe Impacts on U.S. Agriculture ofBiotechnology-Derived Crops Planted in 2005." Technical Report, National Centerfor Food and Agricultural Policy. http://www.ncfap.org/documents/Ouantification%200f%20the%20Impacts%200n %20U5%20Agriculture%200f%20Biotechnology.pdf. Sato, 2008. Suguru Sato. Japan biotechnology annual report. USDA Foreign Agricultural Service GAIN report JA8047. SBREB, 2010. Sugar beet Research and Education Board ofMinnesota and North Dakota. 2010 Production guide. Accessed on May 31, 2010 at: http://www.sbreb.org/Production/production.htm. Schneider F. 1942. Zuchtung der Beta-Ruben. In: Handbuch der Pflanzenzuchtung, vol. 4, Verlag Paul Parey, Berlin, Hamburg. Schneider, 2003. Submitted by Ronald 

### W. Schneider. Monsanto Company, Sl. Louis, MO, USA and KWS SM TAG, Einbeck, Germany. Petition for determination of nonregulated status for Roundup Ready® sugar beet event H7-1. November 17. SESVanderHave, 2010. Sugarbeetsforfood plots. Accessed on July 22, 2010 at: http://www.beetseed.com/store.php Siciliano, SD., and Germida, J.J. 1999. Taxonomic diversity of bacteria associated with the roots offield-grown transgenic Brassica napus cv. Quest, compared to the non-transgenic B. napus cv. Excel and B. rapa cv. Parkland. FEMS Microbiol. Eco/. 29: 273-272. Skaracis, G.N. and M. De Biaggi. 2005. Conventional Breed Methods; Production of Commercial Varieties, p. 199. In: Genetics and Breeding ofSugar Beet, E. Biancardi, L.G. Campbell, G. N. Skaracis, and MD. Biaggi, eds. Sciences Publishers, Ind., Enfield, NH. USA. Smith,2010a. Cindy Smith, APHIS Administrator. Declaration ofCindy J. Smith in US District Courtforthe Northern District ofCalifornia, San Francisco Division, Centerfor Food Safety, et ai, v. Tom Vilsack et al. February 12, 2010. Smith, 201 Db. Cindy Smith, APHIS Administrator. Declaration ofCindy J. Smith in US District Courtforthe Northern District ofCalifornia, San Francisco Division, Center for Food Safety, et ai, v. Tom Vilsack etal. May 7, 2010. Snake River Sugar Cornpany, 2009. FAQs. Accessed on May 30, 2010 at: http://www.amalgamatedsugar.coml. Sonnewald, 2010. Professor Uwe Sonnewald, University ofErlangen-Nuremberg. Interview, reported April 19, GMO Safety. Accessed on June 27, 2010 at: http://www.grnosafety.eu/news/1146.impact-transgenes-basically-Iimited-immediate-function.html Event H7-1 Draft ER 185 References 7/28/2010

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Event H7-1 

### Draft ER 186 

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### Sylvester, R. 

### Member ofthe Michigan Sugar Company Board of Directors and sugar beet grower. Personal communication. July, 2007. Tarantino, 2004. Laura Tarantino, PhD, Director, Office of Food Additive Safety, Centerfor Food Safety and Applied Nutrition, U.S. FDA. Letter to Ronald W. Schneider, Monsanto Company, dated August 17, 2004; Subject: Biotechnology consultation agency response letter BNF No. 00090. Accessed on June 26, 2010 at: http://www.fda.gov/Food/Biotechnology/Submissions/ucm155747.htm Thomas et ai, 2000. John A. Thomas and Gary Hein, Panhandle Research and Extension Center; Shripat Kamble, University of Nebraska, Lincoln. Crop profile for sugar beets in Nebraska. Accessed on May 30,2010 at: http://www.ipmcenters.org/cropprofiles/ListCropProfiles.cfm?typeorg=crop&USDARegion=Natio nal%20Site. Tranel,2003. Patrick J. Tranel, University of Illinois. Weeds and weed control strategies, Chapter 17 in Plants, genes and crop biotechnology, second edition. Maarten J. Chrispeels and David E. Sadava, editors. Jones and Bartlett publishers. Traveller and Gallian, 2000. Del J. Traveller, Amalgamated Sugar Company; and John J. Gallian, University of Idaho. Crop profile for sugar beets in Idaho. Accessed on May 30, 2010 at: http://www.ipmcenters.org/cropprofiles/ListCropProfiles.cfm?typeorg=crop&USDARegion=Natio nal%20Site. UC IPM, 2010. University ofCalifornia integrated pest management. Accessed on June 2 at: http://www.ipm.ucdavis.edu/PMG/weedsmulti.html#BROAD. USDA 1999a. U.S. Department ofAgriculture. Crop profile for sugar beets in Michigan. Accessed on May 30 at: http://www.ipmcenters.org/cropprofiles/ListCropProfiles.cfm?typeorg=crop&USDARegion=Natio nal%20Site. USDA 1999b. U.S. Department ofAgriculture. Crop profile for sugar beets in Oregon. Accessed on May 30 at: http://www.ipmcenters.org/cropprofiles/ListCropProfiles.cfm?typeorg=crop&USDARegion=Natio nal%20Site. USDA2003. Invasive and noxious weeds. Michigan state-listed noxious weeds. Online. Accessed on June 1,2010 at: http://plants.usda.gov/java/noxious?rptType=State&statefips=26. USDA 2009a. U.S. Department ofAgriculture, Natural Resource Conservation Service. Understanding seed certification and seed labels. USDA2010a. U.S. Department ofAgriculture plants database. Accessed on June 14, 2010 at: http://plants.usda.govIjava/profiIe?symbo1=BETA. USDA 2010b. Invasive and noxious weeds database. Accessed on June 14, 2010 at: http://plants.usda.gov/java/invasiveOne?startChar=B

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### http://www

.aphis.usda.gOY

### labout aphis/. USDA APHIS, 2009. U.S. Department ofAgriculture, Animal and Plant Health Inspection Service. Draft Environmental Impact Statement, Glyphosate-TolerantAlfalfa Events J101 and J163: Requestfor Nonregulated Status. November2009. USDAAPHIS, 2010. U.S. Department ofAgriculture, Animal and Plant Health Inspection Service. National Environmental Policy Act Decision and Finding of No Significant Impact, Syngenta Biotechnology Incorporated, MIR162 Maize, SYN-IR162-4. April. USDA APHIS, 201Oa. U.S. Department ofAgriculture, Animal and Plant Health Inspection Service. Petitions of nonregulated status granted or pending by APHIS as ofMay 12, 2010. Accessed on June 26, 2010 at: http://www.aphis.usda.gov/brs/not_reg.html USDAARS, 1962. Improving corn. Accessed on June 30,2010 at: http://www.ars.usda.gov/is/timeline/corn.htm USDA ARS, 2008. U.S. Department ofAgriculture, Agriculture Research Service. NP304 Crop Protection and QuarantineAction Plan 2008-2013, Appendix 

### I. Accessed on June 1, 2010 at: www.ars.usda.gov/

...INP304CropProtectionandQuarantineAppendixl.pdf USDA ARS, 2010a. U.S. Department ofAgriculture, Agriculture Research Service. National Genetic Resources ProgramGermplasm Resources Information Network
- (GRIN) [Online Databasej.National Germplasm Resources Laboratory, Beltsville, Maryland. Accessed on June 14, 2010 at: http://www.ars-grin.gov/cgi-bin/npgs/acc/display.pl?1441384

Event H7-1 

### Draft ER 188 

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### USDAARS, 2010b. U.S. Department ofAgriculture, Agriculture Research Service. National Genetic Resources Program. Germplasm Resources Information Network
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### Reviews ofEnvironmental Contamination and Toxicology. G.W Ware, ed., Vol. 123, New York: SpringerVerlag. Western SugarCooperative, 2006a. Sugar beet process. Accessed on May 30, 2010 at: http://www.westernsugar.com/ProductionAndProcessing.aspx. Western Sugar Cooperative, 2006b. Manufacturing Locations. Accessed on May 30, 2010 at: http://www.westernsugar.com/ManufacturingLocations.aspx. Westgate, 2010. Declaration of MarkWestgate in support ofthe intervenors' opposition to motion for permanent injunction case no. 080484. Whitney, ED. and J.E. Duffus. 1986. Compendium ofBeet Diseases and Insects. pp. 26-32. WHO/FAO, 2006. Word Health Organization and Food and Agriculture Organization ofthe United Nations. Understanding the Codex Alimentarius. Third edition. Wiebe and Gollehon, 2006 Wiebe, K. and Gollehon, N. 2006. "Information Bulletin 16 Agricultural Resources and Environmental Indicators2006 Edition." Technical report, USDA. http://turfweeds.contentsrvr.net/plant.php?do=view&batch=&id= 184http://www.er Event H7-1 Draft ER 190 References 7/28/2010

### s. usda.gov!publications!arei!eib16!eib16.Ddf.World Health Organization (WHO), Food and Agricultural Organization ofthe United Nations (FAO). 2005. Pesticide Residues in Food2005, Joint FAOIWHO Meeting on Pesticide Residues, Evaluations Part I
- Residues, Volume 1. September20
- 29, 2005. Williams, G.M., Kroes, R., and Munro, 

### I. 2000. Safety evaluation and risk assessment ofthe herbicide Roundup and its active ingredient, glyphosate for humans. Pp. 117-165. In 

### Regulatory Toxicology and Pharmacology, Vol. 31. Wilson, 2009. Robert G. Wilson, University of Nebraska-Lincoln. Roundup Ready crops: how havethey changed things? Accessed on July 22, 2010 at: http://digitalcommons.unl.edu/cgilviewcontent.cgi?article=1 02O&context=panpressrel Wilson,2010a. Robert G. Wilson, PhD in support ofintervenors' opposition to PL permanent injustion case no. 08-00484. May6,2010. Wilson,2010a. Robert G. Wilson, PhD in support ofintervenors' reply to PL permanent injustion case no. 08-00484. June 17, 2010. World Health Organization (WHO). 2004. Pesticides in food
- 2004. Report oftheJoint Meeting ofthe and Agriculture Organization ofthe United Nations (FAO) Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group on Pesticide Residues (JMPR). Rome, Italy, 20-29 September2004. FAO Plant Production and Protection Paper 178. World Health Organization and Food and Agriculture Organization ofthe United Nations, Rome, Italy. Accessed on June 17, 2010 at: http://www.fao.org/fileadmin/templates/agphome/documents/Pests Pesticides/JMP R!2008 JMPR Evaluations.pdf. WSSA, 1994. Weed Science Society ofAmerica. Herbicide Handbook, 7th edition. Ed. William H. Ahrens. Weed Society ofAmerica, 1508 West University Avenue. Champaign, Illinois. ISBN#0-911733-18-3. WSSA, 1998. Weed Science Society ofAmerica. Resistance and tolerance definitions. Accessed on July20,2010 at: http://www.wssa.netlWeeds/Resistance/definitions.htm WSSA, 201Oa. Weed Science Society ofAmerica. Composite List ofWeeds as compiled by the Standardized Plant Names subcommittee. Accessed on June 16, 2010 at: http://wssa.netlWeedsIiDlWeedNames/namesearch.php. WSSA, 2010b. Weed Society ofAmerica. WSSA supports NRCfindings on weed control. Accessed on June 16, 2010 at: http://www.wssa.neV York et ai, 2004. A.C. York, A.M. Steward, P.R. Vidrine and A.S. Culpepper. Control of voluntgeer glyphosate-resistant cotton in glyphosate-resistant soybean. Weed Technol. 18:532. Young, 2006. Bryan G. Young. Changes in Herbicide Use Patterns and Production Practices Resulting from Glyphosate- Resistant Crops. Weed Tech. 20:301-307. Zollinger, 2009. Rich Zollinger. 2009 North Dakota Weed Control Guide. North Dakota State University Extension Service. Event H7-1 Draft ER 191 References 7/28/2010Zollinger,2010. Rich Zollinger. 2010 North Dakota Weed Control Guide. North Dakota State University Extension Service. W-253. January. Accessed on May 31, 2010 at: 

### http://www.ag

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.

Event H7-1 Draft ER 192 References 7/28/2010

### AppendixA Willametle Valley Specialty Seed Association (WVSSA) specialty seed production isolation guidelines and Columbia basin vegetable seed field isolation standards

Event H7-1 Draft ER 193 AppendixA 7/28/2010WVSSA Specialty Seed Production Isolation Guidelines Betaspecies (Beets and Swiss chard) Must be pinned atthe Beta species maps Four Separate Groups: Sugar beets, Table beets, Fodder beets, Swiss chard Between one O.P. and another ofthe same color and group Between Hybrid ofthe same color and group Between Hybrid and O.P. ofthe same color and group Between different colors within a group Between stock-seed and a Hybrid within a group Between stock-seed and O.P. within a group Between Hybrids ofdifferent groups Between Hybrid and O.P. ofdifferent groups Between GMO's and any other Beta species no closerthan (And is excluded from exception to lessen this distance) Brassica species (Fall types - 

### 9 chromosomes) Includes: Cabbage, Kale, Kohlrabi, Brussel Sprouts, etc. Between O.P. ofthe same color and group Between O.P. ofdifferent color Between O.P. cabbage and non-heading cultivars (Savoy, Kale, Brussel Sprouts, Collards and Cauliflower) Between Hybrids and Hybrids and O.P. ofthe same color and group Between Hybrids and O.P. ofdifferent colors or group Between Hybrid cabbage and non-heading cultivars Brassica species (Spring types - 

### 6 groups) 1 mile 1 mile 

### 2 mile 

### 3 mile 

### 2 mile 

### 3 mile 

### 3 mile 

### 4 mile 

### 3 mile



### 1 mile 2 mile 

### 2 mile



### 2 mile 

### 3 mile 

### 3 mile



### 1 Turnip types - 

### 10 chromosomes (Japanesetype, purple top, strap leaf, Shogoin) 

### 2 Chinese Mustard types - 

### 10 chromosomes (komatsuna, mizuna, mibuna, tatsoi) 

### 3 Chinese Cabbage types 

### -10 chromosomes (heading, semi-heading, non-heading) 

### 4 Pak Choi types - 

### 10chromosomes 

### 5 Choi Sum types - 

### 10 chromosomes 

### 6 Indian Mustard types - 

### 18 chromosomes (Florida broadleaf, southern giant curled, red mustard, Chinese mustard, leaf mustard) SPECIAL ATIENTION MUST BE PAID TO THESE CROPS AS THERE IS A VERY WIDE RANGE OF PHENOTYPES THAT CAN CROSS. IF THERE IS ANY DOUBT, CHECK WITH THE OTHER COMPANY REP. BEFORE PINNING & PLANTING. Between any 

### 10 chromosome and any 

### 18 chromosome types Between O.P. ofthe same group Between O.P. ofdifferent groups Between Hybrids or Hybrids and O.P. ofsame group and phenotype
Event H7-1 Draft ER 

### 194 Physical separation 

### 1mile 

### 1.5 mile 

### 2 mile Appendix A 7/28/2010Between Hybrids ofdifferent groups or phenotype Between Hybrids and O.P. ofdifferent groups or phenotype 

### Brassicaspecies Canola

Must be grown under permitfrom Oregon Department ofAgriculture. GMO type CanDia or Rapeseed is not allowed to be grown 2.5 mile 

### 3 mile

between any other specialty seed crops. 

### 3 mile Allium cepa (Onion) Male parent used to pin hybrids Onion Hybrid Between Hybrid and O.P. ofdifferent color Between Hybrid and O.P. ofsame color, differentshape Between Hybrid and O.P. ofsame color, shape and type Between Hybrid ofsame color, shape and type Onions Open Pollinated Between Hybrid and O.P. ofdifferent color or shape Between O.P. ofdifferent color Between O.P. ofsame color, but different shape Between Hybrid ofsame color and shape Between O.P. ofsame color, type and shape Allium fistulosum (Bunching Onions) Between anothervariety offistulosum Allium porrum orAllium ampleoprasum (Leek) Between anothervariety of Leek 

### Allium otherspecies (Chives) 

### Umbelliferous otherspecies (Parsley, Dill, Parsnips, etc.)

Between same types Between Hybrid and O.P. ofsimilartypes Between differenttypes 

### Rhaphanus sativus (Radish)

Between O.P. varieties ofsame color and orshape Between Hybrids 

### or Hybrid and O.P. type Between Hybrid and O.P. ofdifferent colors and or shape Between Red globes orfrom White tip type Between Long Red from any other Red type Between Any Red from any other White type Spinacit used to pin hybrids Between O.P. ofthe same leaf shape type Between O.P. ofdifferent leafshape type Between Hybrid and O.P. type Event H7-1 Draft ER 

### 195 

### 2 mile 2 mile 1 mile 

### 3 mile 

### 3 mile 2 mile 

### 2 mile 1 mile

1 mile

2 mile 

### 3 mile

no distance



### 1 mile 

### 2 mile 

### 3 mile

1 mile 2 mile 

### 1 mile 

### 2 mile 

### 3 mile 1 mile 

### 3 mile 

### 3 mile 

### 3 mile

AppendixA

7/28/2010Cichorium intvbus (Chicory) Includes: raddichio, chicory, witloof, fodder root Between O.P. type or endiva species Between Hybrids or Hybrid and O.P. type Cichorium endiva (Endive) Includes: endive, escarole, frizze Between 

### D.P. type Dr intybus species Cucumis sativus (Cucumber)

Types: Slicer, Pickle, White spine, Black spine, Beta alpha.
Between O.P. ofthe same type Between O.P. ofdifferenttype or spine color Between Hybrid and O.P. type Between Hybrid ofdifferenttype orspine color Cucurbitaspecies (Squash)

Includes: pepo, moshchata, mixta, maxima
Between Similartypes, shape and color Between Same or Different species Between another Hybrid ofsimilar variety Between Hybrid and O.P. ofsimilartype and shape Between O.P. or Hybrid ofdifferenttype, shape or color Flowers

All Flowers need to be pinned 1 mile 

### 2 mile

1 mile

1 mile 

### 2 mile 

### 3 mile 

### 3 mile

1 mile 

### 1 mile 1 mile 1.5 mile 

### 2 mile

Between ones that cross pollinate 

### 1 mile Includes: Chrysanthemums, Sunflowers, Helianthus, Poppies, etc. Multiple non-crossing flowers at one location can be pinned with one pin denoting flowers Consult company representatives on general pinned flower locations 

### All otherseed crops need to be pinned.

For isolation distances consult company representatives WVSSA Specialty Seed Production Pinning Rules To facilitate communication and protect the specialty seed industry in the Willamette and Tualatin Valleys ofOregon, isolation mapping procedures have been drafted and agreed upon
Event H7-1 Draft ER 196 AppendixA 7/28/2010

### by the Willamette Valley Specialty Seed Association (WVSSA). The procedures and isolation distances as outlined below have been set up to ensure quality seed production of all vegetable and other specialty seed in the designated areas from potential cross pollination. The isolation control area of interest referred to as the Wrllamette and Tualatin Valleys includes the counties of; Multnomah, Washington, Clackamas, Yamhill, Polk, Marion, Benton, Linn, and Lane. Maps

The association has four separate maps for the purpose of pinning and maintaining appropriate isolation distances. There are two for non-Beta 

### species, and two for Beta 

### species. The maps are then divided by the North and South valley isolation areas. They are established atfour different locations as follows: Non-Beta Species Locations Map1
- North Valley Pinning OSU Extension Service Marion County Phone: 503-588-5301 At: 3180 Center NE, Salem, Oregon 97301 Room 1361 Map 2 - South Valley Pinning OSU Extension Service Linn County Phone: 541-967-3871 At: 104 4th Ave SW, Albany, Oregon 97321 Room 102 BetaSpecies Locations Map 3 - North Valley Pinning West Coast Beet Seed Phone: 503-393-4600 At: 2380 Claxter Rd NE, Salem, Oregon 97303. Map 4 - South Valley Pinning Betaseed, Inc. Phone: 541-926-0161 At: 34303 Hwy 99 E, Tangent, Oregon 97389 The non-Beta 

### types are to be pinned at the non-Beta 

### locations in respectto theirvalley area. The North map is for pinning isolations: Including and North ofTownship 9 South. The South map is for pinning isolations: Including and South ofTownship 9 South. Fields located within Township 9 S. must be pinned on both North and South maps. The Beta 

### types are to be pinned atthe Beta 

### locations in respectto theirvalley area. The North map is for pinning isolations: Including and North ofTownship 11 South. The South map is for pinning isolations: Including and South ofTownship 12 South. Pinning Procedures To identify production fields for location on the map, pins and flags will be used to mark the isolation. On the non-Beta 

### maps, different colorflags are used to separate the major crop types. 1. Must have approved pinning rights and abide by the guidelines ofthe WVSSA. 2. Observe the dates covered underthe priority pinning. 3. Checkfor acceptable isolation distance on the maps. 4. Use properflag to pin the field. Written on each flag will be: Party name, Crop type, Hybrid orO.P., Legal location. 5. Fill out pinning card at time of pinning.
Event H7-1 Draft ER 197 AppendixA 7/28/2010

### 6. At non-Beta maps, have Extension personal date stamp card and place in lock box. 7. At Beta maps, pin as set up at each location, date stamp card and place in lock box. 8. Contact any companies involved ifisolation guidelines are in question. Pins will be placed as close to the center ofthe field to be planted as possible. This will be done to facilitate proper isolation distances to otherfields. The isolation is not valid ifthat isolation is pinned incorrectly. The map cannot be pinned until an established agreement has been made with the grower for planting the crop. The map cannot be pinned on a speculative basis in order to reserve isolation. Upon cancellation of an intended production priorto planting the pin must be removed within 5 days. Upon abandonment of an established production, the pin must be marked failed. A penalty may be assessed of $50.00 if in violation and payment is required to remain a member in good standing. Pinning Priority The WVSSA allows the grower to hold the right to the isolation in his perspective farming area for the following year, to produce the same crop within a one-mile radius to the prior year's isolation. The grower maintains the right to elect the contracting company. The isolation right, known as a prioryear's priority can only be held for the specific grower until the dates specified below. A prior year's priority is only valid until the following dates: For non-Beta species: Annuals
- March 1 st 

### Biennials
- August 1 st 

### For Beta species: Transplants
- February 1st 

### Directseeded
- August 1 st 

### Afterthese dates, all isolations are available on afirst come basis. Pinning Rights: The contracting company or responsible seed representative, who is a member ofthe WVSSA, may do the pinning. The intent is for the contracting company or responsible seed representative to do the pinning. The representative appointed by a company may also do the pinning ifthe company is a member ofthe WVSSA. Oregon State University is considered here as a non-due paying memberthat has pinning privileges. The contracting company or responsible seed representative with a grower agreement acts as the grower's appointed representative in establishing the isolation. Individual growers are to allow their contracting company or responsible seed representative who is a member of the WVSSA, to establish the isolation. Growers are allowed to be members of the WVSSA and would be considered as a responsible seed representative and as a member would be allowed to pin isolations for theirfarms under their own agreements. The contracting company or responsible seed representative agrees to abide by the pinning and isolation guidelines ofthe WVSSA. New pinning parties need to contact an officer of the WVSSA for eligibility approval a membership is required prior to pinning. The responsible party may be required to have membership approval by the association. The association may electto appoint a representative to meetwith the new parties at the appropriate isolation mapto clarify pinning practices.

Event H7-1 Draft ER 198 AppendixA 7/28/2010

### Membership and Pinning Fees: The member or responsible party for the seed is subject to fees as established by the WVSSA. Fees are inclusive of the WVSSA annual membership dues of $150.00 per year, or a Homestead membership fee of $5.00 per year. The pinning fees are; $10.00 per OP crop, $25.00 per Hybrid crop, and $25.00 Multi-crop fee. Annual dues for the current year and pinning fees for the prioryear's pinning are assessed atthe beginning ofeach year. Ifdues and pinning fees are not received, pinning rights may be revoked. A multi-crop fee may apply when producing multiple crop species of an OP in one location, and one acre or less. Only one per member is allowed and is intended for research farms, and small commercial farms used for seed production. The multi-crop fee is not a pin, crop pins must be used to pin different species, and multi-crop must be designated on each card turned in. A Homestead membership fee and no pinning fees may apply for a Homestead non-voting memberwhen producing in one location non commercial OP seed crops. Intended for the seed saver this member is not eligible for the pinning priority and is required to follow WVSSA rules and to be accompanied by a designated appointee when pinning the map. Crop pins must be used to pin different species, and Homestead must be designated on each card turned in. ExceptionsAgreements There are two exception agreements, the Isolation Distance Encroachment, and the One Year Isolation Deferral. The Encroachment exception applies to an established crop isolation where one company agrees to allow another company to produce a like crop under less than the set isolation distance. The deferral applies to an established crop isolation where one grower and company agrees to allow another grower and company to produce a like crop for one year, and the established grower retains the isolation priority. The parties involved prior to planting a specific crop must agree upon any exception to the established isolation for the specific crop year. The exception agreement needs to be in writing annually and to include the right to the isolation the following year. There are exception agreement forms available for this use. All parties must agree and all other WVSSA isolation rules must be followed. Securing Isolations At all maps a system of cards and a lock box will be used and parties using the maps must follow the WVSSA rules. Fields must be currently identified for both the past and present crop year. Failure to pull pins will result in a penalty underthe WVSSA. At the non-Beta maps, at the time of opening the lock box, a representative from two different companies ofthe WVSSA, in addition to an Extension Agent, are required to be present. The lock boxwill be emptied annually when the prior crop year's map is cleared. Atthe Beta 

### maps, the procedures for pinning must be followed at each location. The cards will be date stamped, except not by an Extension Agent, and placed in lock box. The lock box can only be opened and will be emptied annually bytwo members ofthe WVSSA. The purpose ofthe lock box is: 1.To use as the archive and formal record of posting of pins. 2. To review established pinning priority rights. 3. To be used for pinning dispute resolutions. Any discrepancies over pinning locations will be solved through the cards. The cards will be used for accuracy ofpinning and in case ofarbitration. Pinning cards will be archived indefinitely.

Event H7-1 Draft ER 199 

### AppendixA 7/28/2010

### Arbitration Should all precautions fail in preventing potential cross-pollination problems between seed companies or responsible seed representative, and or growers, the WVSSA suggests the following system or arbitration: Fields not pinned will be considered at fault in event 

### of arbitration. Ifthe parties agree to arbitration by the three-person committee, they agree to abide by the committee's recommendation. The two contesting seed companies or responsible seed representative, in consultation with their growers, each chooses an outside field representative from the WVSSA. The arbitrators, A and B, are suggested to a neutral facilitator who notifies them of their. role. They do not know whom they represent and together choose a third committeeman. Arbitrators A, Band C agree to hear the facts of each seed company. Maximum would be two representatives on each side of the issue. After both parties present the facts, only the arbitration committee, A, Band C, remain in the room to discuss the facts fully. They agree to a solution before leaving the room and the chairman will deliver 

### the recommendation immediatelyto both parties. Columbia Basin Vegetable Seed Field Isolation Dates1 

### With a valid "release"', vegetable 

### seed company representatives may reserve fields for vegetable seed production as follows: Annuals and carryover

### onions'
Onion and other biennials (except carrots) Carrots and fall planted annuals February 1 orclosestweekday thereafter March 1 or closestweekday thereafter June 1 or closestweekday thereafter

1 

### These datesfor crops are as per agreement at the January 21, 2005 meeting ofthe Columbia

Basin Vegetable Seed Field Representatives Association. , A release must include the production company, crop, and crop year for placement in

Columbia Basin production and eitherthe number offields or numberofacres.

, Carryover 

### onion crops may be repined with priority between February 1 and March 1, after

which priority is lost. Columbia Basin Vegetable Seed Field Isolation Standards'

Event H7-1 Draft ER 

### 200 Appendix A 7/28/2010All genetically modified crops will be designated as GMO. 

### CARROT FAMILY (Ap;aceae) 

### CARROT (Pinned by Group and Type) Groups: Hybrid and Open Pollinated Types: Chantenay (Danvers, Red Cored, Royal, etc.) American Market (Imperator, etc.) Early (Amsterdam, Baby Carrot, etc.) Medium (Nantes, etc.) Late (Flakkee, Berticum, etc.) Round and Odd Shapes (Paris Forcing, etc.) Oriental (Usually short Chantenay shape) Distance: Between Hybrids

.........................................................................2 miles Between Hybrids and Open Pollinated

.................................

### 2 miles 

### + Between Types within Groups

..............................................1 mile Between Varieties ofsame Type

..........................................'/;, mile Between same Varieties for different companies

.................Y; mile Off-color carrots shOUld be grown outside main production area and pinned by color with a minimum isolation distance of

### 5 miles from other colors.

• Note: A 

### 3 mile isolation will be permitted between Hybrid and Open Pollinated carrots where requested. 

### PARSLEY Between all Types and Varieties

..........................................

### 1 mile 

### CORIANDER (cilantro or Chinese parsley) Between all Types and Varieties 

### 1 mile 

### MUSTARD FAMILY (Cruciferae) 

### RADISH (Pinned by Group and/orType

...Understood to be O.P. unless otherwise noted) Groups: Types:

Event H7-1 Draft ER Hybrid and Open Pollinated Round Red Round Red Forcing Crimson Giant Round Red White Tip Half Long WhiteTip Long Red Icicle (and related forms) Round White Purple Black Other

201 Appendix A 7/28/2010• Standards as of March 1, 2006 as agreed upon by the Columbia Basin Seed Field Representatives Association. Revised 03/06. RADISH Cont'd. Daikon (assumed to be white rooting type unless specified) Daikon Sprouting Daikon, Red Daikon, Green Distance:

.............................................................................................Between Hybrid and Open Pollinated

.............................................................................

### 2 miles Between any red Type and anywhite type

...........................

### 2 miles Between any round white, icicle Type, purple, black, orany Daikon Types and any other radish

......................................

### 2 miles Between Round Red, Crimson Giant, Long Red, round White Tip, and Half Long White Tip

.......................................................1 mile Between Daikon, Sprouting, and any other Daikon ofsame color 1 mile Between Round Red and Round Red Forcing

.....................y" mile Between Round Red Varieties (unless negotiated between companies) y" mile RAPESEED Canola and otherOilseed Types

..............................................................

### 3 miles Genetically modified Canola and other Oilseed Types will be designated as GMO OTHER CRUCIFERS (Pinned by crop name and chromosome number) All Groups orTypes

................................._ ...................................................

### 2 miles ONION FAMILY (Alliaceae) ONION (Pinned by Group and Type) (Allium cepa) Groups: Hybrid and Open Pollinated Hybrid: (Should be posted as male parent) From Hybrid or O.P. ofdifferent color

.........................................................

### 3 miles From Hybrid or O.P. ofsame color, but different shape (Le. Globevs. Flat) 

### 2 miles From O.P. ofsame color and shape

...........................................................

### 2 miles From Hybrid ofsame color, but different shape

...........................................2 miles From Hybrid ofsame color, shape, and Type (Le. Yellow Spanish vs. Yellow Spanish) 

### 1mile From Allium fistulosum, Chives, or Leek

......................................................None Open Pollinated: From Hybrid or O.P. ofdifferent color orshape

..........................................

### 3 miles From O.P. ofsame color, but different shape (Le. Yellow Globe vs. Yellow Ebenezer) 

### 2 miles From Hybrid ofsame color and shape

.........................................................

### 2 miles

Event H7-1 Draft ER 202 AppendixA 7/28/2010From O.P. ofsame color, but differentType (i.e. Yellow Spanish vs. Yellow Globe) miles 1 

## Yz From O.P. ofsame color, Type, and shape (i.e. Yellow Spanish vs. Yellow Spanish) 1 mile From 

### Allium fistulosum, Chives, or Leek

......................................................None 

### (Allium fistulosum) Open Pollinated: From 

### Allium cepa, Chives, or Leek

..............................................................None From anothervariety of

### Allium fistulosum (i.e. Tokyo Long White vs. He-Shi-Ko) 1 mile
ONION Cont'd. Hybrid: From any O.P. or Hybrid 

### A. fistulosum

......................................................

### 2 miles 

### (Allium cepa-fistulosum cross) CFC tetraploid double chromosome Open Pollinated: From 

### Allium cepa or

### Allium fistulosum ofthe same color

............................None From 

### Allium cepa or

### Allium fistulosum ofa different color

...........................None From anotherVariety ofCFC ofthe same color

..........................................

### 1mile From another Variety of CFC ofadifferent color

.........................................

### 3 miles CHIVES From 

### Allium cepa, Allium fistulosum, or Leek

..............................................None From anotherVariety ofchives

....................................................................1 mile LEEK From 

### Allium cepa, Allium fistulosum, Chives

...............................................None From another Variety of Leek

......................................................................1 mile GOOSEFOOT FAMILY 

### (Chenopodiaceae) BEETS Between all Beets, Swiss Chard, and Mangels

...........................................

### 3 miles Sugar BeetTypes: Diploid Tetraploid From Sugar Beets ofthe same or different Type

.........................................2 miles Genetically modified Sugar Beets will be designated as GMO

Even! H7-1 Draft ER 

### 203 AppendixA 7/28/2010

### Appendix B West Coast Beet Seed Company protocol for genetically modified (GM) seed production and GM growerguidelines

Event H7-1 Draft ER 204 Appendix B 7/28/2010

### PROTOCOL FOR GENETICALLY MODIFIED (GM) SEED PRODUCTION (Direct-Seeded, Transplants, Nurseries, Plots)
DETECTION 1. West Coast Beet Seed Company will request the help of Members to set up assay for QC (detection) ofRoundup Ready (RR) gene in sugar beet seed lots. 2. West Coast Beet Seed Company will, from time-to-time, add additional assay of QC (detection) for other events as needed. 3. West Coast Beet Seed Company will conduct the assay for QC of RR on all RR seed lots. Forthe protection ofWest Coast Beet Seed Company and to learn ifthe processes are meeting the desirable criteria, random testing of non-GMO seed lots will be conducted. West Coast Beet Seed Company may consider using zones, based on distances from the GM source, for determining this random testing. Members have the option of requesting all oftheir lots be tested. Members have the option of requesting this information in written form. 4. The shipping documentwill indicatethatthe shipment contains GM seed. 5. West Coast Beet Seed Company assigns a lot number to the potential seed lot prior to the item being planted. This number stays with the seed lot and becomes a permanent record forthis lot. 6. West Coast Beet Seed Company will inform members of all past events grown so members can testtheir seed lots.
ISOLATION 1. West Coast Beet Seed Company's goal is to develop an agreement with sugar beet, chard, and red beet seed companies to avoid cross contamination and to develop a program to inform each other as to the locations of present and past GM and non-GM seed productions. 2. Within a three mile radius ofany RR field, West Coast Beet Seed Company will monitor for any volunteers in any fields used for sugar beet production, over a minimum ofthe pastfive years or until no volunteers are observed. 3. West Coast Beet Seed Company will monitor GM fields for a minimum offive years or until no volunteers are present. This will protect chard, red beet, and sugar beet seed production in the area. The removal ofthe volunteers will be done underthe supervision of West Coast Beet Seed Company representatives and recorded in a log book. The costs will be shared between West Coast Beet Seed Company and the grower. 4. West Coast Beet Seed Company will maintain a minimum three-mile isolation between GM and non-GM sugar beet production. The isolation between GM pollinators/productions where the same event is present will be a minimum of one mile.

Event H7-1 Draft ER 

### 205 Appendix B 7/28/2010The isolation between sugar beet, chard, and red beet will be a minimum ofthree miles until an agreement can be reached with the other companies.
STOCK SEED/STECKLINGS/SEEDTAGS 1. West Coast Beet Seed Company has adopted an orange color tagging system to visually identify GM material (GM stock seed, GM stecklings, GM seed in tote boxes, cotton or burlap bags, GM seed samples, and member's shipping containers). The orange colored tags identify the product as GM and it is to be treated according to the protocol. In respect to each Member company's policies, GM material going to or coming from West Coast Beet Seed Company will be tagged with the preferred identification ofthat membercompany. Member Requirements: 1. Priorto GM stock seed being shipped to West Coast Beet Seed Company, the members will send a document (Movement Traceability Form) identifying the stock seed items (I. D. code number, etc.) that will be GM. 2. Each GM stock seed bag arriving from members will already contain an orange tag marked in writing, stating it is GM seed. The stock seed bags can also contain the Membercompany's GM identifying colored tag, code, symbol, etc. 

### A. Ifstock seed arrives and there are any inconsistencies in the paperwork, orange tagging, non-orange tagging, or any other inconsistency of labeling, the warehouse personnel will notify the Manager and the seed will be put on hold until the member clears the issue and backs it up with the proper documents. The seed will be stored on a separate pallet in the GM portion ofthe warehouse. The pallet will be marked clearly in a manner to prevent it from being prepared for planting. West Coast Beet Seed Company's Requirements: 

### 1. The GM stock seed will be stored separately from the conventional stock seed. The area will be in the main building, along the east wall, near the Warehouse Manager's office and will be identified in a clear manner. 

### A. Non-GM seed will be stored in the northwestwarehouse, ofthe main building, by the main dock. 2. The GM stock seed will be prepared for grower disbursement in the main building, along the eastwall, nearthe Warehouse Manager's office. 

### A. 

### A sample ofthe GM stock seed will be held in a separate area ofthe warehouse for five years. This sample will be labeled with the orange colored tag and the preferred identification ofthe member company. 3. Once the GM stock seed is prepared forthe grower, it will be labeled with an orange tag indicating to the growerthatthey have in their possession GM seed.

Event H7-1 Draft ER 206 Appendix B 7/28/20104. Accompanying the GM stock seed will be a written document declaring that the seed is GM. 

### 5. The stock seed for GM and non-GM productions will not be transported to the growers in the same vehicle at the same time. The field staffwill be trained properly at least once a yearin the handling ofGM seed and all seed movementwill be documented. 6. The field supervisors are responsible for collecting the remaining stock seed from the growers immediately after planting. The Warehouse Managerwill log in the stock seed. When GM stock seed is returned from the growers after planting, sealed bags will be returned to the member. Opened bags will be incinerated at the County garbage burning facilityto prevent use ofpotentially grower-contaminated seed. The Member will be informed, in writing, of the amount, location, and date destroyed. The Memberalso will be informed, in writing, as to amount being returned to them. 

### GM NURSERY 1. The GM nurserywill be kept separatefrom the conventional nursery. A. The owner of the nursery ground will have given West Coast Beet Seed Companywritten permission to plant GM stock seed. 2. The GM stock seed for the nursery will be handled the same as any other GM stock seed (Information from member, orange tag, stored in separate area, etc.) (see above "STOCK_SEED/STECKLINGS/SEEDTAGS"). 

### 3. The digging eqUipment will be completely clean of any stecklings before entering or leaving the GM nursery. West Coast supervisors will sign a document stating they have personally inspected the equipment after cleaning and found it to be free from any stecklings. 

### 4. All GM stecklings will be stored in sacks that are marked with a GM orange tag. The stecklings will be stored in a cooler orwarehouse separatefrom non-GM stecklings. 

### 5. There will be a separate GM observation nursery and it will be isolated in the area where GM productions ofthe same event(s) are being grown.


### GROWING THE CROP (Planters, tillers/fiail, sprayers, separators, male removal, swathers, combines, tote boxes, hauling, tarpsllids)
Any equipment (planter, transplanter, sprayer, flail, tiller, tractor, irrigation equipment, vehicle, separator, clipper, swather, combine, tote box, post-harvest tilling equipment, seed cleaning equipment, or any other equipment) must be monitored, treated,., cleaned, and the process documented, according to West Coast Beet Seed Company's policies.

Event H7-1 Draft ER 207 Appendix B 7/28/2010The intent is to prevent seed, pollen, or stecklings from being transferred out of the area of control or transferred to where they could contaminate other Beta species productions (details ofthe methods are found in other parts ofthis protocol), 1, West Coast Beet Seed Company will use only designated totes for GM seed harvest by growers, Phase one will be metal totes only, Phase two will be metal totes and designated wood totes, A. During transportation, the totes will be covered with a West Coast Beet Seed Company approved high-qualitytarp or high-quality lid, 2, Trucks transporting commercial GM seed will notcarry non-GM seed on the same load, 

### 3, Growers will not be allowed to transfer bulk seed to totes at third party locations (Le, grain elevators) unless, in the opinion of West Coast Beet Seed Company and upon approval ofthe membercompany(ies), the seed can be transferred in a manner that would allow complete and easy transfer without contamination of equipment or surrounding area, To avoid spillage, growers must not transfer seed from one tote to another. 4, Any pesticide application made during the flowering period needs to be done by aerial applications, If aerial application is not possible, then West Coast Beet Seed Company will use its operator and modified equipment to spray, Ifthe grower has high clearance spray equipment that does not leave his farm, then we can consider using this eqUipment The Member will be notified in advance as to which productions West Coast Beet Seed Company will use its equipmentfor spraying after flowering begins, 5, When the GM production is in bloom, any person who enters the field (grower or their workers if they would be going to any other Beta species production, West Coast Beet Company staff or temporary workers, Member or their representatives), will wear disposable coveralls, They are to be removed and disposed of after each use, The disposable clothing will be stored in a separate, closed container so that live pollen cannot escape the area or be transferred into anotherfield, A. Clean, disposable, coveralls will be kept in a closed container prior to use, These coveralls will be furnished at West Coast Beet Seed Company's expense, West Coast Beet Seed Company's field supervisor is responsible for the disbursement ofthe disposable clothes, for having people wear them, for training people howto dispose ofthem, and finally to control the good use ofthem, 

### SEED CLEANING, STORAGE, SHIPPING CONTAINERS, AND SCREENINGS DISPOSAL
1, GM seed will be delivered in designated totes, The totes will be affixed with all appropriate tags, including a GM orange tag which will designate it as containing GM seed,

Event H7-1 Draft ER 

### 208 Appendix B 7/28/2010A. These totes will be stored in a designated portion ofthe warehouse(s) physically separated from non-GM seed. The seed will also be unloaded in a separate area and only GM designated and marked equipment (brooms, conveyors, etc.) will be used for GM seed. B. The field-run samples also will be affixed with a GM orange tag and these samples will be stored separately from non-GM samples. This requirement will be added to the scale house procedures and policies. Scale house personnel will be trained in these procedures, each year, prior to seed delivery. 2. West Coast Beet Seed Company will, in the beginning years, utilize one or two of the cleaning lines to process GM seed. The GM seed will be cleaned at the end of the processing period to avoid potential problems. A. The Company shall not clean conventional and GM seed simultaneously, except in an emergency. In the event of an emergency and the Company must clean conventional and GM seed simultaneously, a physical barrier, such as a plastic wall, shall be put in place to avoid contamination. B. All cleaning equipmentwill be thoroughly cleaned prior to and after cleaning GM seed. This will ensure that all GM seed has been removed from equipment prior to any non-GM seed being introduced after that point. (Detailed instructions of cleaning the equipment are already in place). C. A permanent log is kept forthe cleaning sequence. 

### 3. West Coast Beet Seed Companywill draw a representative clean seed sample and tag it with a GM orangetag. A. Part of this sample will be tagged with a GM orange tag and sent to Agri Seed Testing for germination and purity testing. Agri Seed Testing will be informed that the seed is GM. Agri Seed Testing holds their samples for three (3) years and then will destroythem by incineration in the County garbage burning facility. B. Part ofthe sample will be tested via the QC assay method for the event(s). (This will be expanded to include how this information will be disseminated). See DETECTION category number3, paragraph 1 above. C. A minimum of one (1) pound will be stored in a separate area for five years labeled with an orange tag and the preferred identification of the member company. D. Members attheir request will be senttheir requested amount of properly labeled, clean seed samples. 4. Screenings from GM production will be delivered to either the pellet mill or composting facility.

Event H7-1 Draft ER 

### 209 Appendix B 7/28/2010

### A. West Coast Beet Seed Company will check yearly with the pellet mill company to see ifthe feed pellets will be sold where GM is presently not allowed (Europe)44. West Coast Beet Seed Company will keep members informed on the result of this discussion. B. In the future, regulated screenings can be delivered to a landfill ifrequired. 

### 5. Shipping ofGM seed to members will be in new containers (boxes, poly tote bags, etc.). The containers will be affixed with a GM orange tag and the preferred identification of the member company. Shipping containers (cardboard boxes and poly bags), because they are known to hold some seed in crevices, will not be allowed to be reused at this time. Therefore, West Coast Beet Seed Company would prohibit GM shipping containers from being returned for reuse. A. 

### The paperwork that goes with the seed will indicate seed in truck contains GM seed. B. Forthe protection ofWest Coast Beet Seed Company and its members, GM and non-GM seed will not be shipped on the same truckload to the Members' facilities. GM GROWER GUIDELINES 

### The policy for the grower guidelines will include the following revised reqUirements: 

### 1. The policy will be a part ofthe Grower Contract. 2. 

### The grower will have only a GM production (of one event) or a non-GM production; not both in a given year. This applies to growers who grow only for West Coast Beet Seed Company and to those growers who growfor both West Coast Beet Seed Company and another sugar beet seed company. A. 

### The grower will not raise a GM crop and a chard or red beet seed production in the same year. 

### 3. The growerwill use precaution in the field to eliminate seed from remaining loose on the transport deck priorto leaving thefield. A. 

### Clean offdeck ofloose seed prior to leaving field. This is part ofthe protocol that will be reviewed with the Grower. B. (West Coast Beet Seed Company will work on designing a method to prevent seed from falling between boxes. We may also promote bulk hauling to the plant and transferto boxes). 

### 4. Grower cannot use/share any equipment that might be used in a non-GM sugar beet, chard, or red beet seed production in the same growing year.

44 

### Import of food and feed products derived from Roundup Ready sugar beet event H7-l 

### was approved by the European Union in October, 2007. 

### Event H7-1 

### Draft ER 210 

### Appendix B 7/28/2010

### 5. Grower cannot use same combine to combine GM sugar beet, non-GM sugar beet, chard, or red beet seed in same year. 

### A. The grower will combine 

### 200 acres ofanother crop between combining any beta species. 

### 6. We want a rotation offive crop plantings since the last beta species was grown on the field for seed. 

### 7. Grower training on all aspects of GM growing handling will be conducted by management and field staff.
RECORDKEEPING 

### 1. West Coast Beet Seed Company will continue to maintain a permanent GPS computerized mapping system to record all productions including year, item number, and lot number. 

### 2. West Coast Beet Seed Company maintains a yearly and ongoing computerized log where all important activities ofthe production are recorded (Crop Tracker). The Grower may collect information, but the final responsibility for this data collection is the field supervisor. 3. 

### Crop histories ofherbicide and crop are collected each year priorto planting. 

### 4. West Coast Beet Seed Company will develop a method fortracking all movementofGM seed from the time West Coast Beet Seed Company receives the stock seed, to the final processing and shipment to the member. This information will be communicated to the members upon request. The members may also request additional information when necessary for stewardship ofthe GM crops.
INSPECTION New disposable clothing will be used by West Coast personnel, grower, custom contractor, and member company personnel when entering the field when pollen is present. After each use, the clothing will be discarded into a sealed container and then disposed of in customary container (garbage can, dump box).
RISK ANALYSIS The protocol needs to be continually reviewed. During the review and handling ofthe crop, new areas ofconcern may become evident. When this occurs, the concern must be addressed and solutions implemented. Final approval ofany changes to the contracts must be approved by the Contract Committee and recommended by the committee to the Board of Directors in a timely fashion.

Event H7-1 

### Draft ER TRAINING

211 Appendix B 7/28/2010

### 1. All West Coast Beet Seed Company employees will be trained in all areas of the protocol. Date, time, personnel attending, type of training and instructor should be recorded for all training sessions and appropriately filed. 

### A. West Coast will train personnel on these policies and procedures. Written training documentswill be reviewed and approved by the board. 

### 2. West Coast Beet Seed Company employees that deal with specific areas will have extensive and continual training in the specific area. 

### 3. Both West Coast Beet Seed Company growers and personnel will be trained in the relevant areas of the protocol. Date, time, attendees, type of training and instruction should be recorded for all training sessions and appropriately filed. 4. Part of the training will include the following West Coast Beet Seed Company policy: Operators discovering evidence of spillage or GM seed out of place immediately will inform their supervisor, the head of department, and the West Coast Beet Seed Company Manager. At first evidence ofthe problem, appropriate action will be taken to halt the release of any additional seed, pollen, or plant material. The problem will be evaluated immediately to prevent a reoccurrence. Appropriate individuals or companies will be informed ofthe situation.
GM GrowerGuidelines


### I. The following are guidelines to which all West Coast Beet Seed Company commercial growers are required to adhere in the contract production ofgenetically modified (GM) sugar beet seed. Ifquestions arise with this production, contactWest Coast Beet Seed Company'sfieldmen for clarification orexplanation. Direct seeded and transplant productions will adhere to the guidelines, except with reference to transplanting. West Coast Beet Seed Company will perform the transplanting in winter/spring. 

### A. Field Selection: Genetic purity is ofthe utmost concern with this type ofseed production. Field selection encompasses many characteristics, but the main features that are necessary include fields with required isolation ofat least three miles from non-GM productions and one mile between GM pollinators/productions, the least chance ofhaving volunteer beets from previous productions, good fertility, favorable location (not likely to flood), available for timely plantings into pre-irrigated conditions, good irrigation systems, and good water availability. Ata minimum, a rotation offive crops since the last beta species were grown for seed is required. B. Planting: Stock seed will carry an orange tag to indicate GM. The goal is to plant into fertilized, pH adjusted as necessary, and pre-irrigated fields to ensure timely establishment ofdesired stands. It is desirable to have a population of4-5 

### beets perfoot of row in all lines for direct-seeded production.

Event H7-1 

### Draft ER 212 Appendix B 7/28/2010Stock seed normally is limited in supply, so close monitoring of seed drop is essential to establishing uniform stands across the entire planting. Stock seed will be stored safely to ensure no seed is lost inadvertently or released into the environment inadvertently. All unused stock seed will be returned to company personnel in a timely manner. Planters must be monitored both before and after planting to ensure that the proper seed is being planted. After planting, the planter and the tractor need to be cleaned in the field to remove 100% ofthe seed prior to moving the planterto another location. The intent is to prevent seed from being transferred out ofthe area of control or transferred to where it could contaminate other beta species productions. C. Irrigation: Fall irrigation of direct-seeded production should start after planting, as necessary, and continue through emergence and stand establishment. Spring irrigation of direct seeded and transplant production should begin as the soil moisture drops and crop growth requires supplemental moisture. Spring irrigation should continue as the crop grows and matures to the point that additional moisture is no longer beneficial to production ofaquality crop. West Coast Beet Seed Company personnel will determine the timing ofthe last irrigation. Irrigation equipment will be cleaned ofany live GM pollen before leaving the field. Ifthis is not possible, then irrigation equipment should be left by the field for 

### 24 hours before moving to another location. D. Disposable Clothing Requirements: When the GM production is in bloom, any person who enters the field, and who may enter another Beta species production that same day, will wear disposable coveralls. These will be furnished at West Coast's expense and they are to be removed and disposed of after each use. This will prevent live pollen from being transferred to anotherfield. E. Care of

### the Crop: The crop will be cared for in the best interest of obtaining a high quality and high-yielding production. Management practices of individual fields vary and shall be approved by West Coast Beet Seed Company's field staff. Recommendations by Company representatives will be carried out in a timely and efficient manner. 1. Any pesticide application made during the fiowering period needs to be done by aerial applications. Ifaerial application is not possible, then West Coast Beet Seed Company will use its operator and modified equipment to spray. Ifthe grower has high clearance spray equipment that does not leave his farm, then we can consider using this equipment. F. Pollinator Removal: Removal of pollinator in a timely manner is very important to production of high quality seed. Pollinator destruction will be completed within the time frame agreed upon with West Coast Beet Seed Company representatives. West Coast Beet Seed Company representatives will approve destruction methods and equipment. Equipment will not be used in another

Event H7-1 Draft ER 

### 213 Appendix B 7/28/2010

### beet field until thoroughly cleaned of pollen andlor seed and inspected by West Coast Beet Seed Company field supervisor or his representative. 1. Any equipment (flail, tiller, separator, tractor, vehicle) must be cleaned to kill all live pollen before leaving the field according to West Coast Beet Seed Company's policies. The intent is to prevent pollen from being transferred out of the area of control 

### or transferred to where it could contaminate other Beta species productions. G. Swathing: Swathing will be done in a timely manner as directed by West Coast Beet Seed Company representatives. Swathers will be inspected by West Coast Beet Seed Company's field supervisor for cleanliness prior to and after cutting. Swathers will be cleaned in the field after swathing to ensure that no seed is released into any adjacent field or area. H. Combining: West Coast Beet Seed Company will approve the cleanliness of the growers combine. Before use, the combine must have threshed at least 

### 200 acres ofanother crop since it was used last to combine any other Beta species. Approval for grower combine usage will be determined on a case-by-case basis and will depend on previous crops combined and acreage. Combines must be cleaned before they leave the field to ensure no seed is moved into adjacent areas. Combined seed will be placed in designated tote boxes within the confines of the existing field. Grower will clean off the truck deck in the field to ensure seed is not spilled during transport. West Coast Beet Seed Company's supervisorwill approve the cleanliness ofthe grower's combine before leaving the field. 

### I. Bulk Seed: Growers will not be allowed to transfer bulk seed to totes at third party locations (i.e. grain elevators) unless, upon approval of West Coast Beet Seed Company, the seed can be transferred in a manner that would allow complete and easy transfer without contamination of equipment or surrounding area. To avoid spillage, growers must not transfer seed from one tote to another. J. 

### Hauling Seed: All loads of seed shall be covered with West Coast Beet Seed Company approved, high-quality tarps andlor sealed with lids so no seed can be lost during transport. GM and non-GM seed will 

### not be hauled simultaneously on the same truck. K. 

### Post-Harvest Field Management: Fields will be shallow tilled after harvest to a depth of not more than 3". 

### To promote sprouting of the shattered seed, full irrigation is required, unless a West Coast Beet Seed Company representative determines adequate rainfall has occurred to promote the required sprouting. Fields will not be fall plowed for any reason. Control of sprouted seed is essential to prevent any pollen release and seed formation in future crops.

Event H7-1 Draft ER 

### All tractors and tillage equipment must be monitored and cleaned according to West Coast Beet Seed Company's policies before leaving the field.

214 

### Appendix B 7/28/2010The intent is to prevent seed from being transferred out ofthe area of control ortransferred to where it could contaminate other Beta species productions. L. Fields will be inspected by West Coast Beet Seed Company for a minimum of five years or until no volunteers are noted. M. All ofthese actions will be recorded at West Coast Beet Seed Company in order to establish a record of adherence to GM policy, whether the actions were taken by the grower, the company, or by both in a shared responsibility.

Event H7-1 Draft ER 215 Appendix B 7/28/2010Event H7-1 Draft ER Appendix C International Seed Federation Code ofConduct

216 Appendix C 7/28/2010Summary SEED IS LIFE 

# _SF

lnternationulSeedFederiltion CODE OF CONDUCT (adopted by the ISF Sugarand Fodder Beet Commission)

Principles ofquality assurance in beet seed production. (Final version of22 October2007)

The principles and measures highlighted in this paper aims to the adventitious presence of GM45 beet seed in conventional sugar beet and fodder beet, as well as the adventitious presence ofother GMOs46 in GM sugar beet and fodder beet seed. The adventitious presence of GMOs can only be minimized but not totally excluded because seed production occurs in open fields under natural conditions. There is a strong necessity for practicable rules and regulations governing a high level of purity for seed of conventional varieties relating to adventitious presence of GMOs and for seed of GM varieties relating to adventitious presence ofother GMOs. 

### 1. Objective The objective ofthis industry position paper for the quality assurance ofsugar beet and fodder beet (hereinafter referred to as "beet seed") is to describe the measures the seed industry has taken to minimize the likelihood ofadventitious presence ofGM beet seed in conventional seed or adventitious presence of different GMOs in GM beet seed. The Industry recommends to apply the same measuresto table beet and/or Swiss chard seed production'. This objective is accomplished by implementing guidelines and operating procedures (preventive measures) covering every step from the stage of R&D activities up to delivery of commercial beet seed to the customer. In addition to these measures, actions are undertaken to control the various steps ofthis process. 

### 2. Deregulation of

### GM beetevents The status of deregulation of GM sugar beet events varies according to territories. Similarly, requirements set up by regulators may vary by country. Therefore prinCiples adopted by the industry must reflect these regional differences.

45 GM: Genetically modified 46 GMO: Genetically modified organism This code of conduct has up to now been agreed upon by the following companies: Danisco Seed, Dieckmann GmbH & Co. KG, 

### Fr. Strube Saatzucht GmbH & Co. KG, Maison Florimond Desprez S.A.S., KWS SAATAG, SESVanderHave, Syngenta Seeds and their affiliated companies. It is open for adoption by otherseed companies producing sugarand/orfodder beet seeds. Event H7-1 Draft ER 217 Appendix C 7/28/2010

### 2.1. USA There are three GM sugar beet events which have been deregulated in the USA. One ofthe three events is commercialized since 2007. 

### 2.2. Europe No GM beet events are deregulated at this moment in Europe. As of today no commercialization of GM beet seed can take place in Europe. There is one sugar beet event undergoing the European deregulation process. This process has not been finalized. Similarly there is one fodder beet event undergoing deregulation butthe process is still in progress. 2.3. Otherterritories in the world There is one sugar beetevent undergoing a deregulation process in certain countries.

3. Adventitious presence of GM beetseed 3.1. Adventitious presence in conventional seed Adventitious presence of GM sugar beet seed in conventional beet seed cannot be totally excluded. As oftoday, there are no official thresholds governing the adventitious presence of GM seed in conventional seed in Europe. There is an urgent need for such a threshold to be in place in Europe due to the rnarket introduction ofthe first GM sugar beet in the US. Thresholds will vary and someterritories orcountries may not regulate adventitious presence. Adventitious presence of GM seed in conventional seed would result from the presence of GM seed or GM plants in other beet seed production at some stage of seed production or processing. Three possible main sources of adventitious presence of GM seed in conventional seed productions are identified:

• Spread ofGM pollen to multiplications ofconventional seed. • Unintentional mixing-up ofplants during transplanting. • Unintended traces ofGM seed during harvest, transport, processing orstorage. Quality assurance systems have been implemented to address the issues posed by the adventitious presence. These consist in preventive measures and testing procedures for adventitious presence. They are presented in section 5. 3.2. Adventitious presence in GM seed Adventitious presence of unintended GM seed in GM seed production would result from the presence of GM seed of another event in a production of a given event at some stage of seed production or processing ofGM seed. Similar measures as above in point (3.1) are addressing this case.

Event H7-1 Draft ER 

### 218 Appendix C 7/28/20104. Pre-commercial and commercial production ofGM beetseed 4.1. Europe There are currently no pre-commercial or commercial productions ofGM beetseed in Europe. Until now, production ofGM beetseed in Europe is limited to R&D47activities only. Quality assurance measures thatwould be taken in the future for commercial seed production in Europe will be focused on the separation of GM seed and conventional seed during the whole production procedure (e.g. multiplication and processing steps). In addition to this, tests for adventitious presence and traces of GM beet seed in commercial beet seed lots are performed. 4.2. USA There are commercial productions ofGM beet seed ofone deregulated event in the USA. Quality assurance systems to prevent adventitious presence and traces of GM seed as presented in the data sheetoftheAnnex have been implemented bythe seed industry. These measures are focused on the separation of GM seed and conventional seed during the whole production procedure (e.g. multiplication and processing steps). In addition to this, tests for adventitious presence of GM seed in the GM commercial seed lots were implemented (this refers to traces of another event in a GM seed production based on an intended event).



### 5. Principles for preventive measures and testing procedures for adventitious presence 

### in R&D, 

### in conventional and 

### in GM beetseed production This section describes main measures (preventive measures and testing procedures) to ensure a high level of purity for beet seed regarding Ap48 ofGM. Three base cases cover all situations encountered either as producer ofconventional seed oras producer ofGM seed. The guidelinesfor preventive and control measures havethus been divided into three parts: 1. R&D activities related to GM seed (all stages ofthe seed development upto the basic seed production)
- Data sheet in Annex 1 

### 2. Production ofconventional seed for commercialization
- Data sheet in Annex

### 2 3. Production ofGM seed for commercialization
- Data sheet in Annex 3

Thefollowing sections outline general preventive and control measuresto ensure a high level of purity regarding AP for conventional seed and/or GM seed. 5.1 Preventive measures

47 R&D: Research and development 48 AP: adventitious presence Event H7-1 Draft ER 219 Appendix C 7/28/2010Several principles are implemented in all types ofactivities and operations by each company:

o A quality assurance system is implemented,whereby every GM plant material is recorded and can therefore be traced.
o SOPS49 are written for all aspects ofthe handling ofGM beet plants and GM beet seed and the staffis trained and briefed on their use and application.
o Conventional and GM seed are handled separately, and specific labels or the unique identifierwill be used for all GM material.

o The above mentioned breeding companies have agreed in sharing information on the locations and traits oftheir respective GM seed production worldwide. 5.2 Testing procedures

o Testing for adventitious presence ofGM in conventional seed lots and for unintended events in GM seed lots.

o Exchange information on detection methods ofsuch traits which are shortly before production. More detailed information can be found in the Annexes. Annex 

### 1 Data sheet for "R&D activities for GM and Non-GM (all stages of seed development up to the basic seed production of regulated and deregulated GM beet)". Preventive measures

• All activities involving GM beet plants and GM beet seed are subject of national and international regulations which are adhered to bythe breeding companies. • By sharing information between breeding companies aboutthe locations and traits oftheir respective GM seed production, companies will have the opportunityto redefine their location ofseed production in case it is located close to a conventional seed or another GM event production area. • Minimum offour years of rotation between GM beet seed-crop and conventional beet rootcrop.
o Isolation distance ofat least 1.5 miles between GM and conventional or other GM event seed production. • Bolting plants ofBeta species are removed within a radius ofat least 

### 1000 m around GM multiplications beforeflowering. • SOPs are written for all aspects ofthe handling ofGM beet plants and GM beet seed and the staffis trained and briefed on their use and application. • Transport ofGM seed only in closed containers or bags.
o Storage ofGM seed in dedicated areas separated from conventional seed. • Careful cleaning ofall machinery is carried out before and after each step in the production process ofa GM seed lot orseparate production lines (different GM, Non-GM) are used in the production process.
o Monitoring forvolunteer beets is done atfields or locations used for GM seed production • Shallow post harvesttillage

49 SOP: standard operating procedure Event H7-1 Draft ER 

### 220 Appendix C 7/28/2010Testing procedures

• Seed lots are tested forthe adventitious presence ofGM and GM seed lots for unintended GMO before shipmentto third parties, for example: o Testing ofconventional seed lots used forvariety trials. o Testing ofGM seed lots used forvariety trials. 

### o Testing ofconventional seed lots used in field trials by research institutes and/or industry. 

### o Testing ofGM seed lots used in field trials by research institutes and/or industry.

• Basic seed lots used for commercial production are tested by either PCR or immunological tests and/or herbicide application in case ofherbicide tolerance traits. • Seeds are sampled after harvesting or before pelleting according to internationally accepted sampling techniques.

Annex 2 Data sheetfor "Production ofconventional beet seed for commercialization" Preventive measures
• The above mentioned breeding companies have agreed in sharing information on the locations and traits oftheir respective GM seed multiplications worldwide. • In addition, as part ofthe information sharing, breeding companies will exchange information on detection methods ofsuch traits which are shortly before production. • Isolation distance ofat least 

### 1.5 miles between GM and conventional seed production. • Bolting plants of Beta species are removed before flowering within a radius of 

### 1000 m around GM multiplications. • Minimum offour years crop rotation in seed production. • Separation ofconventional and GM seed during processing • The order of lots processed and pelleted is thoroughly recorded. • Careful cleaning ofall machinery is carried out before and after each step in the production process or use of separate production lines (GM, Non-GM) in the production process Testing procedures

• Conventional seed lots are tested for adventitious presence ofGM seed by either PCR or immunological tests and/or herbicide application. • Seeds are sampled after harvesting or before pelleting according to internationally accepted sampling techniques.

Event H7-1 Draft ER 221 Appendix C 7/28/2010Annex 

### 3 Data sheet for "Production ofGM seed for commercialization" Preventive measures

• All 

### activities involving GM beet plants and GM beet seed are subject ofnational and international regulations which are adhered to by the breeding companies. • SOPs are written for all aspects ofthe handling of GM beet plants and GM beet seed and the staff is trained and briefed on their use and application. • The above mentioned breeding companies have agreed in sharing information on the locations and traits oftheir respective GM seed multiplicationsworldwide. 

### • In addition, as part ofthe information sharing, breeding companies will exchange information on the appropriate detection method for GM traits. • A quality assurance system is implemented, whereby every GM plant material is recorded and can therefore be traced.

o 

### Isolation distance ofat least 

### 1.5 miles between GM and conventional seed production. • Bolting plants ofBeta 

### species are removed before flowering within a radius of 

### 1000 m around GM multiplications.

o 

### The order of lots processed and pelleted is thoroughly recorded. • Careful cleaning ofall machinery is carried out before and after each step in the production process or use of separate production lines (GM, Non-GM) in the production process Testing procedures

o 

### GM seed is tested by either PCR or immunological tests andlor herbicide application in case ofherbicide tolerance traits. Seeds are sampled after harvesting or before pelleting according to internationally accepted sampling techniques.

Event H7-1 

### Draft ER 

### 222 Appendix C 7/28/2010Event H7-1 Draft ER Appendix D Sugar Beet Production by County and State



### 223 Appendix D 7/28/2010Corrm:d:-:y Year Plii"Tied All Purposes HaNEsted y,<:ld ?rnduc:iD:t**1_~uC"C'5e. !Th~Jsards** cfAc:.;s) l""7hous3nds ofA.cF-s) jTlJns) (7hcusands rnTons) '" :

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### ""n 

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# U

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7/28/2010Corrmcdiy Year Courrly Pliirl1e::l All ?urposes HaNE512d**Y~d** Frcduc:iccr Suc:-ose {Th:rJ'5an:::i5 d Ac:esj (Thou5an:::i:of;'.cF-:5) lTor.;;) f7hou.sand5 ofTon5) {?el"Oln;;)**~beets**

# ~~

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## 2G~**?==€16~~, ~'~========+=======~"~00======:#'~~~=42,,~**  ..

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" 110**N"J",~Sl**



### 225 Appendix D 7/28/2010CorrmD:i::y Year Stale



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Appendix D

7/28/2010CorrroD:i:ty**~beels**

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I I 

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Appendix D

7/28/2010Corrm:>:l:::y Year**S~ate** COlJnt'j Pla:"e::l All rtJrpose:s {Thws;;ifids ofAt::1!s)

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Appendix 0

7/28/2010Corrm::.:jy

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Appendix D

7/28/2010CorrmD::>ry

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Event H7-1 Draft ER Ye;;,r S:ate County

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Appendix D

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Appendix D

7/28/2010COlTmo:f.1y**~be,ts** Year Stale

forni'

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Appendix D

7/28/2010Corrmoi::y

Event H7-1 Draft ER Year S'ta!.e

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Appendix D

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### 262 .. 

## ,

Appendix D 7/28/2010Event H7-1 Draft ER 263 Appendix D 7/28/2010Event H7-1 Draft ER Appendix E 2010 Technology Use Guide



### 264 Appendix E 7/28/2010

# TECHNOLOGY USE GUIDE
THE SOURCE FOR MONSANTO'S PORTFOLIO OF TECHNOLOGY PRODUCTS, STEWARDSHIP REQUIREMENTS AND GUIDELINES FOR USE. 

# 2010

### Since 1996, biotech crops have delivered environmental and economic benefits to both farmers and consumers. 

# 1--------------------------

### Source: www.biotech-gmo.com fro

## 'r. .•.....

# /~

# 44 Increased 

# iff; 

# Billion
farmers' net income 

# 475fvWllion
gallons of diesel fuel through reduced**tillaq,~** or plowln(j

### ~ 

# 133 Grownby

# i~O**farmer:worldwi~illion** 

# o

Decreased reliably documented human oranimal safety Issues 

# ;;ff 359,000 ......,-IJ •.lI' •••

: .....

,...,. 

### metrictons* of pesticide applications

Decreased 

# 10MTi'iion metric tons ofgreenhouse gas emissions through fuel savings

environmental impact quotient by 

# 1

I2 % (EIQ)

Have been Ingredients In an estimated 

# 1,000,000,000,000

meals consumed

'"Pesticides regIstered by the U.S. EPA will not cause unreasonable adverse effects to man orthe environment when used in accordance with label directions.

# YOUR ABILITY TO ENHANC YOUR CROPS TODAY! It'stime to ReNEWyour license If you haven't renewed your Monsanto Technology/Stewardship Agreement (MTSA) in the past nine months, take care of 

## it today! Signing the MTSA ensures you'll have access to current and next-wave technologies. These innovations 

### will enhance plant drought tolerance, cold tolerance, nitrogen use efficiency, yield and much more!


# 1-800-768-6387, 

# Option 3 You'll then have the option to complete the process online or through conventional mail.
Paper MTSA's will continue to be accepted.

# Introduction This 2010 Technology Use Guide (TUG) provides aconcise source of technical information about Monsanto's current portfolio of technology products and sets forth requirements and guidelines for the use ofthese products. As a user of Monsanto Technology, it is importantthatyou are familiar with and follow certain management practices. Please read all of the information pertaining to the technology you will be using, including stewardship and related information. Growers must read the Insect Resistance Management (IRM)/Grower GUide priorto planting for important information on planting and IRM. This technical guide is not apesticide product label. It is intended to provide additional information and to highlight approved uses from the product labeling. Read and follow all precautions and use instructions in the label booklet and separately published supplemental labeling forthe Roundup® agricultural herbicide productyou are using.

Included in this guide is information on the following: Stewardship Overview Introducing Genuity'" Insect Resistance Management Weed Management Coexistence and Identity Preserved Production Corn Technologies YieldGard® and Genuity'· Corn Technologies Product Descriptions Roundup Ready® Technology in Corn Cotton Technologies Genuity'" Bollgard II@and Boilgard21Cotton Roundup Ready Technologies in Cotton Genuity·· Roundup Ready 2Yield@ and Roundup Ready Soybeans**----,,-,,-.-----"'----.-"-----~-------'''---------------'"'--------------""-----** " Genuity'" Roundup Ready· Alfalfa Genuitl" Roundup Ready® Spring CanDia**Genuity!~** Roundup Ready@ Winter CanDia Genuity'" Roundup Ready®Sugarbeets

If you have any questions, contact your Authorized Retailer or Monsanto at 1-800-768-6387. 4 6 8 10 12 15

21

31 3S 38 39 40

2010 TECHNOLOGY USE GUIOE

### A Message About Stewardship
- SEED AND TRAITS 

# Monsanto Company is committed to enhancing farmer productivity and profitability through the introduction of new agricultural biotechnologytraits. These new technologies bring enhanced value and benefits to farmers, and farmers assume new responsibilities for proper management of these traits. Farmers planting seed with biotech traits agree to implement good stewardship practices, including, but not limited to:

• Reading, signing and complying with the Monsanto

Technology/Stewardship Agreement (MTSA) and reading all annual license terms updates before purchase or use of any seed containing atrait.
• Reading and following the directions for use on all

product labels.
• Following applicable stewardship practices as

outlined in this TUG.
• Reading and following the IRM/Grower Guide prior

to planting.
• Observing regional planting restrictions mandated

by the U.S. Environmental Protection Agency (EPA).
• Complying with any additional stewardship

requirements, such as grain or feed use agreements or geographical planting restrictions, that Monsanto deems appropriate or necessary to implement for proper stewardship or regulatory compliance.

MONSANTO • Following the Weed Resistance Management Guidelines to minimize the risk of resistance development. • Complying with the applicable IRM practices for

specific biotech traits as mandated by the EPA and set forth in this TUG. • Utilizing all seed with biotech traits only for planting

asingle crop. • Selling crops or material containing biotech traits

only to grain handlers that confirm their acceptance, or using those products on farm.
• Not moving material containing biotech traits across

boundaries into nations where import is not permitted.
• Not selling, promoting and/or distributing within

astate where the product is not yet registered.CROP OR MATERIAL HANDLING STEWARDSHIP STATEMENT

WHY IS STEWARDSHIP IMPORTANT? Each component ofstewardship offers benefits to farmers:
• Signing the MTSA provides farmers access to Monsanto's biotech

trait seed technology. • Following IRM guidelines guards against insect resistance to

Bacillus thuringiensis (B.t.) technology and therefore enables the long-term viability of this technology. and meets EPA requirements. • Proper weed management maintains the long-term effectiveness

of glyphosate'based weed control solutions. • Utilizing biotech seed only for planting a single-commercial

crop helps preserve the effectiveness of biotech traits, while allowing investment for future biotech innovations which further improves farming technology and productivity. Practicing these stewardship activities will enable biotechnology's positive agricultural contributions to continue. Farmers' attitudes and adoption ofsound stewardship principles, coupled with biotechnology benefits, provide for the sustainability of our land resources, biotechnology and farming as a preferred way of life. SEED PATENT INFRINGEMENT If Monsanto reasonably believes that afarmer has planted saved seed containing a Monsanto biotech trait, Monsanto will request invoices and records to confirm that fields in question have been planted with newly purchased seed, Ifthis information is not provided within 30 days, Monsanto may inspectand test all of the farmer's fields to determine ifsaved seed has been planted. Any inspections will be coordinated with the farmer and performed at a reasonable time to best accommodatethe farmer's schedule. Ifyou have questions about seed stewardship or become aware of individuals utilizing biotech traits in a manner otherthan as noted above, please call 1-800-768-6387. Letters reporting unacceptable or unauthorized use of biotech traits may be sent to: MonsantoTrait Stewardship 800 N. Lindbergh Boulevard NC3C st. Louis, MO 63167 For more information on Monsanto's practices related to seed patent infringement, please visit: www.monsanto.com/seedpatentprotection. Provide Anonymous or Confidential reports as follows: "Anonymous" reporting results when a person reports information to Monsanto in such away that the identity of the person reporting the information cannot be identified. This kind of reporting includes telephone calls requesting anonymity and unsigned letters. "Confidential" reporting results when a person reports information to Monsanto in such a way that the reporting person's identity is known to Monsanto. Every effort will be made to protect a person's identity, but it is importantto understand that acourt may order Monsanto to reveal the identity of people who are "known" to have supplied relevant information.


### "Q,<II.- "b!!yond" .-______ 4trBS!!!!d6-

You'rebuyingmoreUmIl**_,~El** juslseed. You're getting value today and innovation fortomorrow. The Beyond the Seed Program was launched by the American Seed Trade Association (ASTA) to raise awareness and understanding of the value that goes beyond the seed. The future success of U.S. agriculture depends upon quality seed delivered by an industry commitment to bring innovation and performance through continued investment. For more information about seed technology, visit ASTA's Beyond the Seed Program at www.beyondtheseed.org.

2010 TECHNOLOGY USE GUIDE

### Genuity'" Unites the Best Traits' 

# As a purchaser of Monsanto biotech trait products, your investment helps fuel the research and development engine that leads to the discovery and delivery of new technologies for agriculture. Current and future Genuity'" traits are designed to deliver high yield potential, maximize return on seed investments and consistently deliver future trait innovations.

CORN Higher yields come from quality grain. Genuity'" VT Triple PRO"· was the next generation of corn technology available for the 2009 growing season. Genuity'" VT Triple PRO'" provides dual modes of action against above-ground pests such as corn earworm, European and southwestern corn borers, sugarcane borer, southerncornstalk borer and fall armyworm. Reduced kernel damage from corn earworm means the potential for reduced Aflatoxin contamination. Genuity'"VT Triple PRO'· dual modes-of-action also allows for a reduction in refuge acres required In southern**[otton~growing** regions while providing long-term effectiveness and consistency.

'" GENUITY'" SMARTSTAX'" Scheduled for launch in 2010, Genuity'" SmartStax'" is the mostwadvanced, ailwin-one corn traitsystem that controls the broadest spectrum of above- and below-ground insects and weeds. Genuity'" Smartstax'" provides control of corn earworm, European corn barer, southwestern corn borer; sugarcane borer, fall armyworm, western bean cutworm, black cutworm, western corn rootworm, northern corn rootworm and Mexican corn rootworm. Genuity'" SmartStax'" contains Roundup**Ready~** 2 Technology and UbertyLink® herbicide tolerance. Genuity'" Smartstax'" also allows for a reduction in refuge acres in the corn belt from 20% down to 5% for above- and below-ground refuge. Genuity'" SmartStai" is also approved for a 20% refuge in the cotton belt.

·See pages 16 and 17 for additional traits. SOYBEAN Genuity'" Roundup Ready 2 YieldlRl soybeans are taking yield to a higher level. They were developed to provide farmers with thesame simple, dependable and flexible weed control and crop safety they've come to rely on with the first-generation Roundup Ready® soybean system, but with higher yield potential. This is possible because ofadvanced insertion and selection technologies. COTTON Genuity"" Roundup Ready® Flex and Genuity-" Bollgard II® offer the ultimate combination of peace of mind and flexibility. They contain unrivaled built-in worm control to stop the most leaf- and bolHeeding worm species, including bollworms, budworms, armyworms, loopers, saltmarsh caterpillars and cotton leaf perforators. Protectingjust one additional boll per plant can result in significantly higher lint yield. The convenience and savings from fewer or no sprays for worms can make a big difference when it comes to the bottom line. SPECIALTY Genuity'" Roundup Ready® alfalfa: Bred from an innovative germplasm pool, it offers outstanding weed control, excellent crop safety and preservation of forage quality potential. Genuity'" Roundup Ready® canola: Offers excellent control of broadleaf weeds and grasses, even in tough weather conditions. Also features excellent crop safety and broad application flexibility. Genuitym Roundup Ready® sugarbeets: Excellent in-plant tolerance to over-the-top applications of labeled Roundup agricultural herbicides. Offers outstanding weed control, excellent crop safety and preservation ofyield potential.

NOTE: Farmers must read the IRM/Grower Guide prior to planting for information on planting and Insect Resistance Management.
MONSANTO

### Monsanto's New Generation of Technologies 

# As Monsanto continues to develop new generations of technologies, several of our newer technologies are migrating to the Genuity"" brand. These products and their new logos are presented below.



# Vll!ldlillrd

# VI>' wlip> 

# Triple PRO VTTrlplcPRO 

## CORN

# BOI~U with

# g Roundup Ready- Cotton 

## COTTON

SPECIALTY BollgardII Roundup ReadyFlex

GrowtheFeed l Nolthe WeedL" 

## SOYBEANS

BoUgard11

# BolI~U with

# g t:7:::;;D>' RoundupReady.

### flex**Rcu~dup** Dollg.nlil RullyFlo

RoundupReady

2010 TECHNOLOGY USE GUIDE 

# II

# An EFFECTIVE IRM program is a vital part of responsible product stewardship for insectP/anlingR./ugB5,P",.rv/ngTechn%gy 

# protected biotech products. Monsanto is committed to implementing an effective IRM program for all of its insectprotected B.t. 

# technologies In 

# ali countries where they are commercialized, including promoting farmer awareness of these IRM programs. Monsanto works to develop and implement IRM programs that strike a balance between available knowledge and practicality, with farmer acceptance and implementation of the plan as critical components.

The U.S. EPA requires that Monsanto implement, and farmers who purchase insect-protected products follow, an IRM plan.* IRM programs for B.t. traits are based upon an assessment of the biology ofthe major target pests, farmer needs and practices, and appropriate pest management practices. These mandatory regulatory programs have been developed and updated through broad cooperation with farmer and consultant organizations, including the National Corn Growers Association and the National cotton Council, extension specialists, academic scientists, and regulatory agencies.

*In some areas, a natural refuge option is available for BoligarElIi. See the current IRM!Grower Guide for details. 

# II MONSANTOThe IRM programs for planting seeds containing

### at traits contain several important elements. One key component of an IRM plan is a refuge. A refuge is simply a portion of the relevant crop (corn or cotton) that does not contain a B.t. technology for the control of the insect pests which are controlled by the planted technology(ies).The lack of exposure to the B.t. proteins means that there will be susceptible insects nearby to mate with any rare resistant insects that may emerge from B.t. products. Susceptibility to B.t. products is then passed on to offspring, preserving the long-term effectiveness of the technology. Farmers who purchase seeds containing B.t. traits must plant an appropriately designed refuge. Refuge size, configuration, and management is described in detail in the sections on those products in the 2010 IRM/Grower Guide. FailUre tofollow IRM requirements and to plant a proper refuge may result in the loss of a farmer's access to Monsanto technologies. Monsanto is committed to the preservation of B.t. technologies. Please do your part to preserve B.t. technologies by implementing the correct IRM plan on your farm. 

### MONITORING PROGRAM The U.S. EPA requires Monsanto to take corrective measures in response to afinding of IRM non-compliance. Monsanto oran approved agent of Monsanto must monitor refuge management practices. The MTSA signed by afarmer requires that upon request by Monsanto or its approved agent, afarmer must provide the location of all fields planted with Monsanto technologies and the locations of all associated refuge areas as required, to cooperate fully with any field inspections. and allow Monsanto to inspect all fields and refuge areas to ensure an approved insect resistance program has been followed. All inspections will be performed at a reasonable time and arranged in advance with the farmerso that the farmer can be present ifdesired.

Farmers must read the current IRM/Grower Guide priorto planting for information on planting and IRM. Ifyou do not have a copy of the current IRM/Grower Guide, you may downloaded it at www.monsanto.com. or you may call 1-800-768-6387 to request a copy by mail.

2010 TECHNOLOGY USE GUIDE

# Monsanto considers product stewardship to be a fundamental component of customer service and responsible business practices. As leaders In 

# the development and stewardship of Roundup" agricultural herbicides and other products, Monsanto invests significantly in research to continuously improve the proper uses and stewardship of our proprietary herbicide brands.

This research, done in conjunction with academic scientists, extension specialists and crop consultants, includes an evaluation of the factors that can contribute to the development of weed resistance and how to properly manage weeds to delay the selection for weed resistance. Visit www.weedtool.com for practical, best practices-based information on reducing the risk for development of glyphosate-resistant weeds. Developed in cooperation with academic experts, the website provides options for managing the risk on a field-by-field basis. Glyphosate is a Group 9 herbicide based on the mode of action classification system of the Weed Science Society of America. Any weed population may contain plants naturally resistant to Group 9 herbicides.The following general recommendations help manage the risk of weed resistance occurring. WEED RESISTANCE MANAGEMENT PRACTICES: • Scout your fields before and after herbicide application • Start with a clean field, using either a burndown herbicide

application ortillage • Control weeds early when they are small • Add other herbicides (e.g. aselective**in~crop** and/or aresidual

herbicide) and cultural practices (e.g. tillage or crop rotation) as part of your Roundup Ready® cropping system where appropriate • Rotation toother Roundup Ready crops will add opportunities for

introduction of other modes of action

· Use the right herbicide product at the right rate and the right time • Control weed escapes and prevent weeds from setting seeds • Clean equipment before moving from field to field to minimize

spread ofweed seed • Use new commercial seed that Is as free from weed seed

as possible

Note: Always read and follow all pesticide label requirements. 

# II MONSANTO Monsanto is committed to the proper use and**long~term** effectiveness of its proprietary herbicide brands through a**four~part** stewardship program: developing appropriate weed control recommendations, continuing research to refine and update recommendations, education on the importance ofgood weed management practices and responding to repeated weed control inquiries through aproduct performance evaluation program. GLVPHOSATE-RESISTANT WEEDS Monsanto actively investigates and studies weed control complaints and claims of weed resistance. When**glyphosate~** resistant weed biotypes have been confirmed, Monsanto alerts farmers and develops and provides farmers with recommended control measures, which may include additional herbicides,**tank~mixes** or cultural practices. Monsanto actively communicates all of this information to farmers through multiple channels, including the herbicide label, www.weedscience.org, supplemental labeling, this TUG, media and written communications, Monsanto's website, www.weedresistancemanagement.com. and farmer meetings. Farmers must be aware of, and proactively manage for,**glyphosate~resistant** weeds in planning their weed control program. When a weed is known to be resistant to glyphosate, then a resistant population of that weed is by definition no longer controlled with labeled rates ofglyphosate. Roundup® agricultural herbicide warranties will not cover the failure to control**glyphosate~resistant** weed populations. Report any incidence of repeated non-performance on a particularweed to your local Monsanto representative, retailer or county extension agent.ROUNDUP BRAND AGRICULTURAL OVER-THE-TOP HERBICIDE PRODUCTS

MONSANTO BRANDS OF SELECTIVE OVER-THE-TOP HERBICIDE PRODUCTS Herbicide products sold by Monsanto for use overthe top of Roundup Ready crops for the 2010 crop season are as follows:

Roundup WeatherMAX® Roundup PowerMAKID
Read and follow all product labeling before using Roundup agricultural herbicides overthe top of Roundup Ready traits. To learn more aboutapplicable supplemental labels orfact sheets, call 1-800-768-6387. Tank-mixtures of Roundup agricultural herbicides with insecticides, fungicides, micronutrients or foliar fertilizers are not recommended as they may result in reduced weed control. crop injury, reduced pest control or antagonism. Refer to the Roundup agricultural herbicide product label, supplementa! labeling or fact sheets published separately by Monsanto for tank-mix recommendations. Do not add additional surfactants and/or products containing surfactants to these Roundup agricultural herbicides unless otherwise directed bythe label. Otherglyphosate products labeled for use in Roundup Ready technologies may require the addition ofsurfactants, or other additives to optimize performance, that may increase the potential for crop injury. Monsanto will label and promote only fully tested brands that do not require surfactants and otheradditives for over-the-top applications to Roundup Ready Crops. GLYPHOSATE ENDANGERED SPECIES INITIATIVE Before making applications of glyphosate-based herbicide products, licensed farmers of crops containing Roundup Ready technology must access the website www.pre-serve.org to determine whether any mitigation requirements apply to the planned application to those crops, and must follow all applicable requirements. The mitigation measures described on the website are appropriate for all applications of glyphosate-based herbicides to all crop lands. Farmers making only ground applications to crop land with a use rate of less than 3.5 Ibs ofglyphosate a.e./A are not required to access the website. If a farmer does not have web access, the seed dealercan access the website on behalf of the farmer to determine the applicable requirements, or the farmer can call 1-800-332-3111 for assistance.

In certain areas, populations of ryegrass,johnsongrass, marestail,common ragweed, giant ragweed, PalmerAmaranthandwaterhemp are known to be resistantto glyphosate. Forcontrol recommendations for resistant biotypes oftheseweeds, refertowww.weedresistancemanagement.comorcall 1,800-768,6387.When approved, supplemental labeling forspecific herbicide products can also beviewed onwww.cdms.netorwww.greenbook.netorobtained bycalling 1'800-768-6387.

2010 TECHNOLOGY USE GUIDE

# IIICoexistence in agricultural production systems and supply chains is not new. Different agricultural systems have coexisted successfully for many years around the world. Standards and best practices were established decades ago and have continually evolvedto deliver high purityseed and grain to support production, distribution and trade of products from different agricultural systems. For example, production of similar commodities such as field corn, sweet corn and popcorn has occurred successfully and in close proximity for many years. Another example is the successful coexistence of oilseed rape varieties with low erucic acid contentforfood use and high erucic acid content for industrial uses. The introduction of biotech crops generated renewed discussion of coexistence focused on biotech production systems with conventional cropping systems and organic production. These discussions have primarily focused on the potential economic impact of the introduction of biotech products on othersystems. The health and safety of biotech products are not an issue because their food, feed and environmental safety must be demonstrated before they enter the agricultural production system and supply chain. The coexistence of conventional, organic and biotech crops has been the subject of several studies and reports. These reports conclude that coexistence among biotech and**non~biotech** crops is not only possible but is occurring.They recommend that coexistence strategies be developed on a**case~by~case** basis considering the diversity of products currently in the market and underdevelopment, the agronomic and biological differences in the crops themselves and variations in regional farming practices and infrastructures. Furthermore, coexistence strategies are driven by market needs and should be developed using current**science~based** industry standards and management practices. The strategies must be flexible, facilitating options and choice for the farmer and the food/feed supply chain, and must be capable of being modified as changes in markets and products warrant. Successful coexistence ofall agricultural systems is achievable and depends on cooperation, flexibility and mutual respect for each system. Agriculture has a history of innovation and change, and farmers have always adapted to new approaches or**chal~** lenges by utilizing appropriate strategies, farm management practices and new technologies.



# II MONSANTO The responsibility for implementing practices to satisfyspecific marketing standards or certification lies with that farmer who is growing acrop tosatisfy a particular market. Only that farmer is instructed to employ the practices appropriate to assure the integrity of his/her crop. This is true whether the goal is**high~oil** corn, white/sweet corn or organically produced yellow corn for animal feed. In each case, the farmer is seeking to produce a crop that is supported by a market price and consequently that farmer assumes responsibility for satisfying reasonable market specifications. That said, the farmer needs to be aware of the planting intentions of his/herneighbor in orderto gauge the need for management practices. IDENTITY PRESERVED PRODUCTION Some farmers may choose to preserve the identity of their crops to meet specific markets. Examples of Identity Preserved (I.P.) corn crops include production ofseed corn, white, waxy orsweet corn, specialty oil or protein crops, food grade crops and any other crop that meets specialty needs, including organic and**non~genetically** enhanced specifications. Farmers of these crops assume the responsibility and receive the benefit for ensuring that their crop meets mutually agreed contract specifications. Based on historical experience with abroad range of I.P. crops, the industry has developed generally accepted J.P. agricultural practices. These practices are Intended to manage I.P. production to meet quality specifications, and are established for a broad range of I.P. needs. The accepted practice with I.P. crops is that each I.P. farmer has the responsibility to implement any**neces~** sary processes. These processes may include sourcing seed appropriate for I.P. specifications, field management practices such as adequate isolation distances, buffers between crops, border rows, planned differences in maturity between adjacent fields that might cross-pollinate and harvest and handling practices designed to prevent mixing and to maintain product quality. These extra steps associated with I.P. crop production are generally accompanied by incremental increases in cost of production and consequently ofthe goods sold.

### General Instructions for Management of Pollen Flow and Mechanical Mixing For all crop hybrids or varieties that theywish to identity preserve, or otherwise keep separated, farmers should take steps to prevent mechanical mixing. Farmers should make sure all seed storage areas, transportation vehicles and planter boxes are cleaned thoroughly both prior to and subsequent to the storage, transportation or planting of the crop. Farmers should also make sure all combines, harvesters and transportation vehicles used at harvest are cleaned thoroughly both prior to and subsequent to their use in connection with the harvest of the grain produced from the crop. Farmers should also make sure all harvested grain is stared in clean storage areas where the identity of the grain can be preserved. Self-pollinated crops, such as soybeans, do not present a risk of mixing by cross-pollination. If the intent is to use or market the product of a self-pollinated crop separately from general commodity use, farmers should plant fields a sufficient distance away from other crops to prevent mechanical mixture. Farmers planting cross-pollinated crops, such as corn oralfalfa, who desire to preserve the identity of these crops, orto minimize the potential for these crops to outcross with adjacent fields ofthe same crop kind, should use the same generally accepted practices to manage mixing that are used in any of the currently grown I.P. crops ofsimilar crop kind. It is generally recognized in the industry that a certain amount of incidental, trace level pollen movement occurs, and it is not possible to achieve 100% purity of seed or grain in any corn production system. A number of factors can influence the occurrence and extent of pollen movement. As stewards of technology, farmers are expected to consider these factors and talk with their neighbors about their cropping intentions. Farmers should take into account the following factors that can affect the occurrence and extent of cross-pollination to or from other fields. Information that is more specific to the crop and region may be available from state extension offices.
• Cross-pollination Is limited. Some plants, such as potatoes, are

incapable of cross-pollinating, while others, like alfalfa, require cross-pollination to produce seed. Importantly, cross-pollination only occurs within the same crop kind, like corn to corn. • The amount of pollen produced within the field can vary. The pollen produced by the crop within a given field, known as pollen load, is typically high enough to pollinate all of the plants in the field. Therefore, most of the pollen that may enter from other fields falls on plants that have already been pollinated with pollen that originated from plants within the field. In crops such as alfalfa, the hay cutting management schedule significantly limits or eliminates bloom, and thereby restricts the potential for pollen and/orviable seed formation. • The existence and/or degree of overlap In the pollination period

of crops in adjacent fields varies. This will vary depending on the maturity of crops, planting dates and the weather. For corn, the typical pollen shed period lasts from 5 to 10 days for a particular field. Therefore, viable pollen from neighboring fields must be present when silks are receptive in the recipient field during this brief period to produce any grain with traits introduced by the out-of-field pollen. • Distance between fields of different varieties or hybrids ofthe

same crop: The greaterthe distance between fields the less likely their pollen will remain viable and have an opportunity to mix and produce an outcross. For wind-pollinated crops, most crosspollination occurs within the outermost few rows ofthe field. In fact, many white and waxy corn production contracts ask the farmer to remove the outer12 rows (30 ft.) of the field in order to remove most ofthe impurities that could result from cross' pollination with nearby yellow dent corn. Furthermore, research has also shown that as fields become further separated, the incidence ofwind-modulated cross-pollination drops rapidly. Essentially, the in-field pollen has an advantage over the pollen coming from other fields for receptive silks because of itsvolume and proximityto silks. • The distance pollen moves. How far pollen can travel depends on

many environmental factors, including Weather during pollination, especially wind direction and velocity, temperature and humidity. For bee-pollinated crops, the farmer's choice of pollinator species and apiary management practice may reduce field-to-field pollination potential. All these factors will vary from season to season, and some factors from day to day and from location to location. • For wind-pollinated crops, the orientation and width of the

adjacent field in relation to the dominant wind direction. Fields oriented upwind during pollination will show dramatically lower cross-pollination for wind-pollinated crops, like corn, compared to fields located downwind.

2010 TECHNOLOGY USE GUIDE 

# III

# Advanced breeding and biotechnology have had a major impact on farming production. From 1971 to 1995, average corn yields were increasing at a rate of 1.5 bushels per acre, per year. Since the advent of biotech in 1996, corn yields have increased at a rate of 2.6 bushels per acre, per year, for atotal increase of 32 bushels per acre."

Excellence Through Stewardship Monsanto Company is a member of Excellence Through Stewardship® (ETS). Monsanto products are commercialized in accordance with ETS Product Launch Stewardship Guidance, and in compliance with Monsanto's Policy for Commercialization of**BiotechnolQgy~Derived** Plant Products in Commodity Crops. This product has been approved for import into key export markets with functioning regulatory systems. Any crop or material produced from this product can only be exported to, or used. processed orsold in countries whe.re all necessary regulatory approvals have been granted. It is aviolation of national and international law to move material containing biotech traits across boundaries into nations where import is not permitted. Growers should talk to theirgrain handler or product purchaserto confirm their buying position forthis product. Excellence Through Stewardship@ is a registered trademark of Biotechnology Industry Organization. For specific refuge requirements for B.t. corn and cotton, see the current IRM/Grower Guide, sent with this TUG. Ifyou have not received a copy of this Guide, it can be downloaded at www.monsanto.com. or**call1~800~768~6387** to request a copy be mailed to you.

Before opening a bag of seed, be sure to read and understand the stewardship requirements, including applicable refuge requirementsfor insectresistancemanagement. forthebiotechnology traits expressed in the seed as setforth in the Monsanto TechnologyAgreementthatyou sign. By opening and using a bag ofseed, you are reaffirmingyour obligationto comply with those stewardship requirements.

• USDA Yields were calculated using 3 year rolling**a~erages** (32 Yield is 2.6bu/ac *12 years). 2008 Yield is from Doane Ag Services forecast In April 8,2008QuarterlyCrop Outlook.

2010 TECHNOLOGY USE GUIDE 

# II

### Genuity'" Trait Productsand YieldGard® Corn Technologies Product Descriptions

GENUITY'" SMARTSTAX'" Scheduled to launch in 2010, Genuity'W SmartStax'" is the most advanced, all-in"one corn trait system that controls the broadest spectrum of above- and below-ground insects and weeds. Genuity"" SmartStax'" hybrids will contain B.t. proteins that represent three separate modes of action for control of lepidopteran, aboveground insect pests, as well as combined modes of action for control of coleopteran, below-ground insect pests. Providing multiple B.t. proteins for control will dramatically decrease the probability that insects will become resistant to the traits, resulting in enhanced durability of transgenic insect control via B.t. genes. Based on this multiple gene approach, Genuityt" SmartStax·" is approved for reduced refuge in the corn belt from 20%down to 5% for both above- and below-ground pests. The cotton belt refuge for Genuity SmartStax'" is also reduced, from 50% down to 20%.**VTTrip!~**PRO
GENUITY'" VT TRIPLE PRO'" (Formerly YieldGard VT Triple PRO")
- Genuity' VT Triple PRO" is available in selected southern corn- and cotton-growing areas. It includes broad-spectrum insect control against corn earworm, European and southwestern corn borers, sugarcane borer, southern cornstalk borer, fall armyworm, western corn rootworm, northern corn rootworm and Mexican corn rootworm. Its advanced control of ear pests can result in higher grain quality and higher-yielding crop potential. The dual mode-of-action of Genuity'" VT Triple PRO

.... allows for lower corn borer refuge acres in southern cotton-growing areas compared to other registered B.t.-traited products. It includes thesame Roundup Ready® 2 Technology as Monsanto's previous product, YieldGard VT Triple. Seed containing Genuity'" VT Triple PRO

.... technology is treated with seed-applied insecticide.*

MONSANTO 

# V,eldlillrd

# I(f> Tripie
YIELDGARD VT TRIPLE@ YieldGard VT Triple technology combines YieldGard Corn Borer and YieldGard VT RootwormiRR2® technology into a single plant. YieldGard VT Triple corn hybrids control European and southwestern corn borer, sugarcane borer, southern cornstalk borer, western corn rootworm, northern corn rootworm and Mexican corn rootworm. YieldGard VT Triple technology suppresses corn earworm, fall armyworm and stalk borer. By providing in-plant protection against the above insect pests, the genetic yield potential of YieldGard VT Triple corn hybrids is preserved. YieldGard VT Triple corn hybrids also include Roundup Ready 2 Technology. This trait allows a farmer to experience the benefits of utilizing Roundup agricultural herbicides in a weed control system that provides the broadest weed control spectrum available. better application flexibility, and superior crop safety. Seed containing YieldGard VT Triple technology is treated with seed-applied insecticide.*

VTOoublllPRO
GENUITY'" VT DOUBLE PRO'" Genuity'" VT Double PRO'" is a new corn technology scheduled for launch in 2010. It includes broad-spectrum insect control against corn earworm. European and southwestern corn borers, sugarcane borer, southern cornstalk borer and fall armyworm. The dual mode-of-action of Genuity'" VT Double PRO'" allows for lower corn borer refuge acres compared to other registered B.t.-traited products. Seed containing Genuity'" VT Double PRO·" technology is treated with seed-applied insecticide.*

*A seed·applied insecticide Ciln protectseed. roots and seedlings from insects such as black cutworm, wireworm, white grubs, seed corn maggots, chinch bug and earlyflea beetles.

# flllI!ldlillrdW--::p**1F1@@1E'i&!'@If'IlifUIIF1IF1~** YIELDGARD VT ROOTWORM/RR2'" YieldGard VT Rootworm/RR2 technology is the current VietdGard stacked-trait product for control of western corn rootworm, northern corn rootworm and Mexican corn rootworm. Protecting the root of the corn plant from feeding by corn rootworm larvae decreases lodging and protects the genetic yield potential of YieldGard VT Rootworm/RR2 corn hybrids. The Roundup Ready 2 Technology allows afarmer to experience the benefits of utilizing Roundup agricultural herbicides in aweed control system that provides the broadest weed control spectrum, better application flexibility and superior crop safety. Seed containing YieldGard VT Rootworm/RR2 technology is treated with seed-applied insecticide.*

YIELDGARD'" CORN BORER YieldGard Corn Borer corn hybrids contain an insecticidal protein from B.t. that protects corn plants from European corn borer. southwestern corn borer; sugarcane borer and southern cornstalk borer resulting in full yield potential.

Maxlmom IlISectProlDcUOD YIELDGARD PLUS YieldGard Plus corn technology combines YieldGard Corn Borer and YieldGard Rootworm technology into a single plan.

YIELDGARD ROOTWORM YieldGard Rootworm corn hybrids contain an insecticidal protein from B.t. that protects corn roots from larval feeding by western, northern and Mexican corn rootworm. YIELDGARD" CORN BORER WITH ROUNDUP READY'" CORN 2 YieldGard Corn Borer with Roundup Ready Corn 2offers farmers all the benefits of both traits combined in one crop. These hybrids exhibit the same insect protection qualities as YieldGard Corn Borer and, like Roundup Ready Corn 2, are tolerant to over-the-top applications of Roundup@ agricultural herbicides.

YIELDGARD PLUS WITH ROUNDUP READY CORN 2 YieldGard Plus with Roundup Ready Corn 2 offers farmers all the benefits of all three traits combined in one crop. These hybrids exhibit the same insect protection qualities of YieldGard Corn Borerand YieldGard Rootworm and, like Roundup Ready Corn 2, are tolerant to over-the-top applications of Roundupf!'! agricultural herbicides. Seed containing YieldGard Plus technology is treated with seedvapplied insecticide.*

YIELDGARD ROOTWORM WITH ROUNDUP READY CORN 2 YieldGard Rootworm with Roundup Ready Corn 2 offers farmers all the same insect protection qualities as YieldGard Rootworm and, like Roundup Ready Corn 2, is tolerant to over-the-top applications of Roundup agricultural herbiCides.

*A seed'applied insecticide can protectseed,roots and seedlingsfrom Insects suchas blad cutworm,wireworm. white grubs. seed corn maggots,chinch bug and early Ilea beetles.
2010 TECHNOLOGY USE GUIDE

### ROUNDUP READY® Technology in Corn WEED CONTROL RECOMMENDATIONS Roundup Ready® Corn 2 (RR2) and corn with Roundup Ready® 2 Technology are equivalent in theirtolerance to Roundup agricultural herbicides. Products with Roundup Ready Technology contain in-plant tolerance to Roundup agricultural herbicides. The Roundup Ready® Technology system's flexibility, broadspectrum weed control and proven crop safety offerfarmers weed control programs that allow them to use the system in the way that provides the greatest benefit. Farmers can select the program that best fits the way they farm. Options include the use

PROGRAM For usewhere residual herbicidesare typically used for early-seasonweed control: Residual Herbicide Plus Roundup WeatherMAX®

Forusewhere total postemergence programs are effective and sustainable: RoundupWeatherMAX Sequential Maximum Use Rates For Roundup We,therMAX of a residual herbicide with a Roundup® agricultural herbicide, tank-mixing other herbicides with Roundup agricultural herbicides where appropriate and a total postemergence program.
INSTRUCTIONSAND USE RATES' Usethe properRoundup Ready RATE'"ofBulietO, Degree®, Degreextra®, Harness®)iarnessXtra, Harness Xtra5.6l, Micro'Tech"',orlariat!l (no post)asdefined in thetable belowand the individual product labels,either pre orpostemergencetothe crop."" follow with RoundupWe,lherMAX at16to 11ozfA postsequentially afterpreemergence application or tank-mixed in-crop with the residual. Applications should be made before weeds exceed 411 in height. Roundup Ready RATEs***

Harness 1.5 Pints Degree 3.0 Pints Harness Xtra I.Z Duarts Harness X!ra 5.6l 1.5 Quarts DegreeXtra Z.O Quarts Micro-Tech Z.O Quarts lariat 2.0 Quarts Bullet 2.0 Quarts Apply RoundupWeatherMAX ,116to 11ozfA before weeds exceed 411 in heightand follow with asecond application at 16 to 22oz/Aforan additionaillush of weeds beforetheyexceed4"in height.

Products with Roundup Ready2Technology In-crop: "32oz/A persingle application "Total:64 oz/Afrom emergencethrough 4811 heightof

corn, drop nozzles mustbeusedfrom 3011to48!!corn. AGRONOMIC PRINCIPLES Corn yield is very sensitive to early-season weed competition. Weed control systems must provide farmers the opportunity to control weeds before they become competitive. The Roundup Ready Technology system provides a mechanism to control weeds at planting and once they emerge. Farmers are provided excellent crop safety and full yield potential, with applications made from planting through 4811 ofcorn height. Drop nozzles must be used between 30" and 48" of corn height. Failure to control weeds with the right rate, at the right time and with the right product, can lead to increased weed competition, weed escapes and the potential for decreased yields. Use otherapproved herbicide products with Roundup agricultural herbicides if appropriateforthe weed spectrum.

ADDITiONAL INFORMATION Usefull labeled rate ofresidual when application is 14daysor more priorto planting orwhentough grassesare present. e.g., barnyardgrass,shattercane, seedlingjohnsongrass,sandbur. Use aminimum of2.5 pt/A of Harness on woolly cupgrass and wild proso millet. Products containing atrazine will provide improved control ofcocklebur, giant ragweed, PalmerAmaranthand morningglory, Tank'mixproductssuch as2,4'0, dicamba orStatus® herbicidewith Roundup WeatherMAXforcontrol ofglyphosate'resistant marestail (horseweed), Palmer Amaranthand otherdifficulHo-controlweeds. Use22to32oz/A01 RoundupWeatherMAX"when morninggloryorperennialweeds are presentorwhen broadleafweedsare411 in heightortaller.

Use22to 32oz/A of RoundupWeatherMAXwhen morninggloryorperennial weeds are present. Tank"mixproductssuch as 2,4-0, dicamba orStatus herbicide with Roundup WeatherMAXforcontrol ofglyphosate'resistant marestail (horseweed), Palmer Amaranthand otherdilficulHo-control weeds.
Products with Roundup Ready2TechnologyTotal Season: The combined total ofpreplant. in-crop and preharvestapplications of RoundupWeatherMAXcan notexceed5.3qt/A,The combined total of in'cropand preharvest applications can notexceed 66oz/A.

"Ifusing anotherRoundupilgriculturillherbicide.you mustrefer 10IhelabE'lbookletorRoundup ReadyCorn2Technology supplemenlallabclfor lliatbrandto delermine appropriateuserales.lfusing RoundupPawerMAX', applicJlion rales oJreIhesameas torRoundupWedtherMAX,nusing anolherresidualherbicide,followthelabeleduserateinstructionsapplicableto Roundup ReildyComZ.followallpesticidelabelrequirements

.

..

Atrazinemayalso beused asaresidualherbicideinthe Roundup ReadvCorn 2System. '''Yaumayapplyup10Ihefull residualherbicidelabeledralelorcorn. MONSANTOWEED RESISTANCE MANAGEMENT FOR CORN WITH ROUNDUP READY TECHNOLOGY • Or apply a pre-emergence residual herbicide atthe recommended rate tank-mixed with Roundup WeatherMAX" at a minimum of Follow all pesticide label requirements and the guidelines below to minimize the risk of developing glyphasate-resistant weed populations in a Roundup Ready Technology system. 22 az/A in-crop before weeds exceed 4" in height. • Follow with a postemergence in-crop application of Roundup

WeatherMAX at a minimum of 22 az/A for additional weed flushes before they exceed 4" in height. • Start clean with a burndown herbicide ortillage. Early-season

weed control Is critical to yield. • Roundup WeatherMAX may be tank-mixed with other herbicides for postemergence weed control. • Apply pre-emergence residual herbicides such as Harness Xtra,

Degree xtra or other residual herbicides at the recommended rate. • Report repeated non-performance to Monsanto oryour local retailer.

RECOMMENDATIONS FOR MANAGING GLYPHOSATE-RESISTANT WEEDS IN PRODUCTS WITH ROUNDUP READY TECHNOLOGY

Glyphosate-Resistant Marestail (Horseweed)

Glyphosate-Resistant Amaranthu5Species

- PalmerAmaranth

-Waterhemp

G

Iyphasate-Resistant AmbrosiaSpecies

-Giant Ragweed

-Common Ragweed

Glyphosate-Resistant Johnsongrass start clean with aburndown program ortillage. -Tank-mix Roundup agricultural herbicides with 2,4-0, ordieamba, according to the label directions, In-crop, tank-mix22 ounces peracreof RoundupWeatherMAXwith Clarity· (B 1016fluid ounces peracrel or2,4-0 10.5to 1.0 Ib active ingredient per acre) from corn emergence to the 5·lealstage ofcorn grawlh (approximalely B"talil. Ortank'mix 22ounces peracre of Roundup WeatherMAXwith 5ounces peracreofStatus® herbicidewhen the corn is 4" to 36" tall (V2 to VIO). Marestail should not exceed 6 11 in heightat thetime ofin-crop application.**-~~** Slarl cleanwith aburndawn program ortillage. Usearesidual herbicidesuch as Harness Xtra, Harness Xtra 5.6L. DegreeXtra orotherresidual herbicideeither preemergence or in-crop forcontrol ofAmaranthusspecies. In'crap,tank-mix Roundup WeatherMAXwith otherherbicidessuch as 2,4-0, dieamba (Clarity orBanvel®) orstatus herbicide 10 control emerged weeds. Applications ofstatus herbicideshould be made when the corn is between 4" and 36" tall (V21a VlO), follow all label directions. Amaranthusspecies should not exceed 3 11 in heightat thetime of in-cropapplication. Starl clean with aburndawn program ortillage. Use aresidual herbicide such as Harness Xtra, Harness Xtra 5.6l, DegreeXtra orotherresidual herbicide either preemergenceorin-crop forcontrol ofAmbrosiaspecies. In'crop, tank-mix Roundup WeatherMAX wilh alherherbieides such as 2,4-0, dieamba (Clarity orBanvel) orSlatus herbicide 10canlral emerged weeds. Applications ofStatus herbieide should be madewhen the corn is between 4" and 36" lall (V210 V10). followall label directions. Ambrosiaspecies should notexceed 3" in heighl atthe time ofin-crop application. start clean with aburndown programortillage. Use aresidual herbicide such as Harness Xtra, Harness Xtra 5.6L, DegreeXtra orotherresidual herbicidecontaining atrazine preemergence to reduce the competition from seedling johnsongrass priorto the emergenceofcorn. In-crop, tank-mix Roundup WeatherMAXwilh aherbicide suchas Accent", Equip"or Option· lorcontrol ofemerged weeds including seedling and rhizomejohnsangrass. follow all label directions oftank-mix partners, especially Ihase related to weed size. In certainareas, Italian ryegrass is known to be resistantto glyphosate. Forcontrol recommendations, refertowww.weedreslstancemanagement.com orcall1-800-768-6387.Whenapproved,supplemental labeling forspecificherbicide products can also beviewedonwww.cdms.netorwww.greenbook.net.

'Followall**pesticid~**labelrequirements2010 TECHNOLOGY USE GUIDE 

# II

### Genuity'" Bollgard II'

### and Boligard'"' Cotton Descriptions

Bcllgardll

GENUITY'" BOLLGARD II' COTTON Genuity·· Boligard [F" cotton contains two distinct insecticidal proteins from Bacillus thuringiensis (B.t.) that increase the efficacy and spectrum ofcontrol and reduce the chance that resistance will develop to the B.t. insecticidal proteins, relative to 8ollgardl'! cotton. Genuity'" Bollgard**[!~** cotton normally provides excellent, season-long control oftobacco budworm, pink bollworm and cotton bollworm. Genuity'" Bollgard W' cotton provides good protection against fall armyworm, beet armyworm, cabbage and soybean loopers and othersecondary leaf- orfruiHeeding caterpillar pests of cotton. Applications of insecticides to control these insects are substantially reduced with Genuity'" Bollgard**Ir~** cotton.

The U.S. Environmental Protection Agency has mandated the following terms and conditions:*

• Bollgard"cotton may be sold through September30,2009. After that

date. all sales of Bollgard cotton are prohibited. • All Bollgard cotton seed must be planted by midnight ofJuly1, 2010

(the expiration date ofthe Bollgard cotton registration). AfterJuly1. 2010, planting of Boligard cotton seed is prohibited. Any Bollgard cotton seed not planted on or beforeJuly1, 2010, must be returnedto either the retailer orto Monsanto. No refunds are to be issued on Bollgard cottonseeds bought for planting in 2010 and returned by growers. • An adequate amount of refuge seed must be purchased for planting

an appropriate refuge for Bollgard cotton. Purchase of refuge seed with the Bollgard cotton seed is mandatory, and such seed must be purchased by growers In advance of theIr receipt of Bollgard cotton
"-It is aviolation of federal law to sell or distribute an unregistered pesticide. NOTE: Sale or commercial planting of Bollgard'''cotton is prohibited in certain states, Including: Arizona, California, Colorado, Kansas, New Mexico and Oklahoma. Sale or planting of Bongard Is prohibited in the Texas counties of: Carson, Dallam, Hansford, Hartley, Hutchison, LIpscomb, Moore, Ochlltree, Roberts, and Sherman. Sale or commercial planting of both Genuity"' Bollgard II"and Bollgard Is prohIbIted In Hawaii, Puerto Rico, the U.S. VIrgIn Islands, and In Florida south of Route 60 (near Tampa).

# BOI~ 

# td

BOLLGARD' COTTON Bollgard cotton contains asingle insecticidal protein from B.t. that provides good control against three major lepidopteran insect pests ofcotton. Specifically, Bollgard cotton provides excellent,**season~long** control oftobacco budworm and pink bollworm, and suppression ofcotton bollworm. When the**above~mentioned** insect larvae feed on Bollgard cotton plants, the B.t. protein protects the plants from damage by reducing larval survival. Under high infestation, application of insecticides may be necessary to protect 80llgard cotton.

seed. Any seed purchased for use as a refuge is non'refundable, unless the proportional amount of Bollgard cotton seed that the refuge seed would have supported is returned at the same time. • Any order for replacement or additional Bollgard cotton seed for

the 2010 planting season, that does notconform tothe requirements stated above must be filled with Genuity'" Bollgard 11 10 cotton seed (or other products with current registrations). • On-farm IRM assessmentswill be conducted during the planting season. • In 2010, Bollgard cotton may only be planted in: Alabama, Arkansas,

Florida (Northofflorida Route 60), Georgia. Kentucky, Louisiana, Maryland, Missouri, Mississippi, North Carolina, South Carolina, Tennessee, Texas (excluding the ten prohibited Texas panhandle counties of: Dallam, Sherman, Hansford, Ochiltree, Lipscomb, Hartley, Moore, Hutchinson, Roberts, and Carson) and Virginia.
The B.t. delta endotoxin protein expressed in this cotton targets certain cotton Insect pests. Routine applicatIons of insecticIdes to control certain Insects are usually unnecessary when cotton contaInIng the B.t. delta endotoxin protein Is planted. However, Jf Insecticide appl1cations are necessary to control certaIn cotton Insect pests, follow all label requirements.

2010 TECHNOLOGY USE GUIDE

### Genuity" Boligard II" and Boligard" Cotton 

# GolF ncllgardl!

INSECT RESISTANCE MANAGEMENT (IRM) Lepidopteran cotton pests have demonstrated the ability to develop resistance to many chemical insecticides. As a**pre~** emptive measure, Genuity'" BoHgard II':!> and Bollgard''' cotton must be managed in ways thatwill retard insect resistance development. These practices are designed to ensure that some lepidopteran populations are not exposed to the B.t. proteins so they can maintain susceptibility in select populations. In orderto achieve this, refuge cotton that does not contain B.t. proteins must be planted. GENUITY'" BOLLGARD II
- DUAL EFFECTIVE DOSE Resistance management is critical to the long-term viability of our technology and the benefits realized by ourfarmer customers. 2010 is atransition year for Monsanto B.t. cotton products as we shift all U.S. cotton acres toward the two-gene insect control product, Genuity'" BoHgard 11'" cotton. The move to multiple-gene products, including Genuity'· Bollgard II'''', offers dua! effective modes of action against target insect pests, increasing the longevity of the technology. INTEGRATED PEST MANAGEMENT (lPM) Integrated Pest Management (IPM) is an effective and environmentallysensitive approach to pest managementthat relies on a combination of cammon-sense practices. IPM programs use current, comprehensive information on the life cycles of pests and their interaction with the environment.This information is used to manage pests in a manner that is least harmful to people, property and the environment. Prevention Using the best agronomic management practices in conjunction with the appropriate cottonvarieties will yield the greatest benefits. Use varieties, seeding rates and planting technologies appropriate for each specific geographical area. As much as possible, manage the crop to avoid plant stress.
• Employ appropriate scouting techniques and treatment decisions

to preserve beneficial insects that can provide additional insect pest control.

MONSANTO . Manage forappropriate maturity and harvest schedules. destroy stalks immediately after harvest to avoid regrowth and minimize selection for resistance in late-season Infestations

. • Use soli management practices that encourage destruction

of over-wintering pupae. Monitor and Identify Fields should be carefully monitored for all pests, including cotton bollworms, to determine the need for remedial insecticide treatments. Fortarget pests, scouting techniques and supplemental treatment decisions should take into account the fact that larvae must hatch and feed before they can be affected by the B.t. protein(s) in either Genuitym Bollgard I[:l' or Bollgard cotton. Fields should be scouted regularly, following periods of heavy orsustained egg lay, especially during bloom, todetermine ifsignificant larval survival has occurred. Scouting should include a modified wholeplant inspection, including terminals, squares, blooms, bloom tags and small bolls. Larvae larger than 1/4 inch (3- to 4-days old) are generally recognized as survivors that may not be controlled by Genuity' Bollgard II'or Bollgard cotton.

Read the lRM/Grower Guide prior to planting for information on planting and Insect Resistance Management. Ifyou do not have a copy of this Guide, you may download it at www.monsanto.com. or cal!**1-800-768~6387** to request a copy by mail.
Control Monsanto recommends the use ofappropriate remedial insecticide treatments to ensure desired levels of control if any cotton insect pest reaches locally established thresholds in Genuity'" Bollgard II'" or Bollgard cotton. Although Genuityt. Bollgard II" and Bollgard cotton will sustain less damage from some of the most troublesome lepidopteran pests, they will not provide protection against non-lepidopteran species. These insects should be monitored and treated with insecticides when necessary, using recommended thresholds. Whenever possible, select insecticides that are least harmful to beneficial insects.

NOTE: In 2010, sale orcommercial planting of Boligard' cation Is prohibited In the following states: Arizona, California, Colorado, Kansas, New Mexico aml Oklahoma

. In 2010, sale or planting of 8ollgard' is prohibited in the Texas counties of: Carson. Dallam. Hansford. Hartley. Hutchison, Lipscomb, Moore. Ochiltree. Roberts, and Sherman. In 2010, sale or commercia! planting of both**Genuity~** 80llganl II' and**8ol!gard~** is prohibited in Hawaii. Puerto Rico, and the U,S, Virgin Islands, or in Florida south of Route 60 (near Tampa).

### Roundup Ready<'> Cotton, Genuity'" Boligard 

### II" with Roundup Ready@ Cotton and Bollgard with Roundup Ready Cotton

ROUNDUP READY COTTON Roundup Ready'" cotton varieties contain**in~plant** tolerance to Roundup'!!) agricultural herbicides, enabling farmers to make in-crop applications of Roundup WeatherMAX'E' or Roundup**PowerMAX'~** according to label requirements.

MARKET OPTIONS Gin by-products of cotton containing Monsanto's biotech traits, including cottonseed for feed uses, are fully approved for export to Canada, Japan, Mexico and South Korea. Cottonseed containing Monsanto traits may not be exported for the purpose of planting without a license from Monsanto. It is aviolation of national and international lawto move material containing biotech traits across boundaries into nationswhere Import is not permitted. RECOMMENDED MANAGEMENT PRACTICES Managing Roundup Ready cotton, Bollgard with Roundup Ready cotton and Genuity'''Bollgard I(:ll with Roundup Ready@cotton requires thata farmer follow the recommended management practices associated with cotton containing each individual trait. Farmers of Bollgard with Roundup Ready cotton and Genuity'" Bollgard II'" with Roundup Ready'"' cotton varieties must follow the same guidelinesfor establishing required refuge options, practicing IRM and managing target and non-target pests as described for Bollgard and Genuity'" Bollgard IP cotton in the IRM/GrowerGuide. APPLICATION OF ROUNDUP WEATHERMAX" AND ROUNDUP POWERMAX" Roundup Ready cotton is genetically improved to provide tolerance to glyphosate, the active ingredient in Roundup agricultural herbicides. Roundup Ready cotton can receive over-the-top applications of Roundup agricultural herbicides only through the four-leaf stage. With the Introduction mACK"- t:DUTn"- MorathanFour, Poat·DlraC'!. BoUganili
GENUITY'" BOLLGARD II WITH ROUNDUP READY COTTON AND BOLLGARD WITH ROUNDUP READY COTTON**Genuity·~** Bollgard II'" with Roundup Ready:fO cotton and Boligard with Roundup Ready varieties offer farmers the benefits of both insect protection and glyphasate tolerance combined in one crop. These varieties exhibit the same insect protection qualities as Genuity"" Boligard W' and Boligard cotton and enable farmers to make in-crop applications of Roundup WeatherMAX or Roundup PawerMAX according to label requirements.

of Genuity''' Roundup Ready'" Flex cotton, there is the potential for both Roundup Ready cotton and Genuity·· Roundup Readyf) Flex cotton to be used on a farmer's farm. This creates concern forthe crop safety of Roundup Ready cotton. Monsanto recommends that farmers:
• Maintain accurate records ofwhich technologies have been planted

and where they have been planted. • Communicate the field plan with other members of their work

force to ensure properapplications for each technology. • Clearly mark fields to indicate which technology has been planted. WEED RESISTANCE MANAGEMENT GUIDELINES Follow all pesticide label requirements and these guidelines to minimize the risk of developing glyphosate-resistant weed populations in a Roundup Ready cotton system:
• Scout fields before and aftereach burndown and in-crop application. • Start clean with a burndown herbicide program or tillage. • Use the right herbicide product at the right rate and right time. • Add soil residual herbicide{s) and cultural practices as part

of a Roundup Ready weed control program. • In-crop, apply Roundup WeatherMAX at a minimum of 22 ozlA

when weeds are less than 6" in height. • Tank-mix other approved herbicides with Roundup WeatherMAX

if necessary for postemergence weed control. • Clean equipment before moving from field to field to minimize

the spread of weed seed (as well as nematodes, insects and other cotton pests). • Should repeated non-performance occur, report to Monsanto

or your local retailer.

2010 TECHNOLOGY USE GUIDEWEED CONTROL RECOMMENDATIONS Weed control in cotton is essential to help maximize both fiber yield and quality potential. Cotton is verysensitive to**early~** season weed competition, which can result in unacceptable stands and/or reduced yield potential. The Roundup Ready"" cotton system provides farmers with the right tools to control weeds before they become competitive.

PROGRAM Preplant Burndown

Residual Herbicides

Over-The-Top through Fourth Leaf

Selective Equipment

Preharvest Over-The-Top Applications INSTRUCTIONS AND USE RATES' Always start clean by planting into aweed-freefield using eithertillage oraburndown application. In no-till and reduced-till systems, apply apreplant burndown application of Roundup WeatherMAX··· at 11to 44oz/A in a tank-mix with dicamba or1,4-D, Seethe dicamba and 1,4-D product label for rates and time intervals required between application and cotton planting. State restrictions mayapply. Apply residual herbicide(s) as part ofaRoundup Ready cotton weed control program. Use the recommended label rate and timing ofthe residual herbicide applied. Referto individual product labels for list of residual herbicidesthat may be used. Apply RoundupWeatherMAXoverthe topfrom crop emergence through thefourth true-leaf (node) stage (untilthe fifth true leafreachesthe sizeofaquarter). Two applications can be madeduring this period atamaximum rate of 11 aliA per application, Referto the "Annual Weeds RateTable" in the Roundup WeatherMAX label for rate recommendations forspecific annual weeds.

Afterthefourth true-leafstagethrough layby, Roundup WeatherMAX may be applied using precision post-directed orhooded sprayerswhich direct the spray to the base of the cotton plant. Two post-directed applications can be made during this period at amaximum rate of 12 aliA per application.
Before harvest and aftercotton reaches 10% boll-crack, if needed, apply up to 44 aliA of Roundup WeatherMAX. This treatment is effective in controlling late-season perennial weeds and can improve harvestefficiency. ADDITIONAL INFORMATION Early-season weed competition can result in unacceptable stands andlor reduced yield potential. This tank-mix is recommended forcontrol and management ofglyphosate-resistant marestail (Conyza sp.) orother tough-to-control weeds. Burndown application should be made farenough in advance ofplanting to control existing weeds.
The residual herbicide(s) may be applied as eithera preemergence (including preplant incorporated), postemergence, andlor layby application as allowed onthe label ofthe specific product being used. In-crop over-the-top applications must be at least ID days apart and the cotton must have at leasttwo nodes ofincremental growth between applications. Care should betaken to record growth stage atfirst application. In situations wherethe potential forweed infestations is high (including perennial weeds), make the first application early enough to allow asecond application before cotton exceedsthe fourth true-leafstage.Over-the-topapplicationsafterthe fourth true-leaf stagecan result in boll loss, delayed maturity, andlor yield loss. Place nozzles in alow horizontal position to permit spray patternto overlap inthe rowwhile contact of spraysolution with cotton leaves should be avoided to the maximum extent possible. Excessive foliarcontactcan result in boll loss, delayed maturity, andloryield loss. There must be two nodes ofgrowth and at least 10 days between applications. Applications must be made at least7days priorto harvest. Roundup agricultural herbicides are not effective for preharvest cotton regrowth in Roundup Readycotton. Do not apply Roundup agricultural herbicides preharvest to crops grown for seed undercontract atan authorized cotton seed company. Roundup Readycotton has excellent vegetative tolerance to Roundup WeatherMAX allowing early-season over-the-top applications. Incomplete reproductive tolerance requires that applicationsafterthe 4-leaf(node) stage be properly post-directed. ATTENTION: Use of Roundup agricultural herbicides in accordance with label directions is expected to result in normal growth of Roundup Ready cotton, however, various environmental conditions, agronomic practices, and otherfactors make it impossible to eliminate all risks associated with the product, even when applications are made in conformance with the label specifications. In some cases, these factors can result in boll loss, delayed maturity, andloryield loss.
-Follow all pesticide label requirements. *-Ifusing another Roundup agricultural herbicide,you must refer tothe label booklet or Roundup Ready cotton supplemental label forthat brand to determine appropriate use rates. If using

Roundup PowerMAX", application rates are the same as for Roundup WeatherMAX.
MONSANTOIIcllg.rdll -

# B~~!9Qfd Roundup Ready Catton RECOMMENDATIONS FOR MANAGING GLYPHOSATE-RESISTANT WEEDS

Glyphosate-Reslstant Marestail (Horseweed)

Glyphosate-Reslstant AmaranthusSpecies**~** PalmerAmaranth

- Waterhemp

Glyphosate-Resistant AmbrosiaSpecies

- Giant Ragweed**~** Common Ragweed

Glyphosate-Reslstant Johnsongrass Startclean with aburndown herbicide program ortillage. -Tank-mix Roundupagricultural herbicides with dicamba or2,4-D (consult label for plant backtiming). Ifyou have dense standsof marestail, use apreplant residual herbicide at the recommended rate and timing, such as diuron (Direx®) orflumioxazin (Valor®). Use Roundup WeatherMAX in-crop, as needed, at aminimum of22oliA to control otherweeds. In-crop, ifapplying post-directed to glyphosate-resistant marestail, Roundup WeatherMAX can be tank-mixed with other herbicides, such asdiuron or MSMA. Marestail should be less than 6" in heightat the time ofin-cropapplication. Startclean with aburndown herbicide program ortillage. Apply apreemergence residual herbicide such as pendimethalin (Prowl®) plus fluometuron orfomesafen (Reflex®)orflumioxazin (Valor) forcontrol ofAmaranthusspecies. In-crop, tank'mix RoundupWeatherMAX at22 oz/A with metolachlororother labeled chloracetamide herbicide before Amaranthu5species emerges. Use Roundup WeatherMAX in-crop, as needed, at aminimum of 22oliAto control otherweeds. Apost-directed application of RoundupWeatherMAX tank-mixed with MSMAand aresidual such as diuron (Direx) orflumioxazin (Valor) should be made to control Amaranthusspedes 3" orsmallerin height and preventadditional flushes. --_ ....

_--_. 

# __.•._- Start clean with aburndown herbicide program ortillage. Apply apreemergence residual herbicidesuch as pendimethalin (Prowl) plus fluometuron orfomesafen (Reflex)forcontrol ofAmbrosiaspecies. In-crop, tank'mix RoundupWeatherMAX at22oliA with metolachlor beforeAmbrosiaspecies emerges. Use Roundup WeatherMAX in-crop, as needed, at aminimum of 22oliAto control otherweeds. Apost-directed application of RoundupWeatherMAX tank-mixed with MSMAand aresidual such as diuron (Direx) or flumioxazin (Valor) should be madeto control AmbrosiaspeCies 3" orsmallerin heightand prevent additional flushes. Startclean with aburndown herbicide ortillage. Preplant incorporatearesidual herbicide such as pendimethalin ortrifluralin forcontrol orsuppression ofseedling johnsongrass. Apply RoundupWeatherMAX in atank-mix with herbicidessuch as SelectMAX®, Assure® II orPoast Plus forthe control of emerged weeds including seedling and rhizomejohnsonqrass. Follow all label directions oftank-mix partners,especially those related toweed size. ---_.--_.. 

# _._............ _._... _--_

..- ---_...... Incertain areas, Italian ryegrass is known to be resistantto glyphosate. Forcontrol recommendations, referto www.weedresistancemanagement.com orcall 1-800-768-6387.When approved,supplemental labeling forspecific herbicide productscanalso beviewedon www.cdms.netorwww.greenbook.net.
-Follow all pesticide label requirements.

2010 TECHNOLOGY USE GUIDE

### Genuity" Roundup Ready® Flex Cotton and Genuity'" Boligard 

### II" with Roundup Ready" Flex Cotton

RoundupReadyFlex
GENUITY'" ROUNDUP READY' FLEX COTTON**Genuity'~** Roundup Ready" Flex cotton varieties possess improved reproductive tolerance to Roundup® agricultural herbicides. This technology gives farmers the opportunity to make Dver-the-top broadcast applications of labeled Roundup agricultural herbicides from crop emergence up to seven (7) days prior to harvest.

MARKET OPTIONS Genuity'" Roundup Ready!i Flex cotton and Genuity'" Bollgard II® with Roundup Ready Flex cotton have regulatory clearance in the United states, but do not have import approval in all export markets. Processed fractions from these products, including linters, oil, meal, cottonseed and gin trash, must not be exported without all necessary approvals in the importing country. Itis a violation of national and international law to move material containing biotech traits across boundaries into nations where import is not permitted. RECOMMENDED MANAGEMENT PRACTICES Managing Genuity'" Roundup Readye Flex cotton and Genuity'" Bollgard II;' with Roundup Ready'" Flex cotton requires a farmer to follow the recommended management practices associated with cotton containing each individual trait. Farmers ofGenuity'" Bollgard Jr" with Roundup Ready']O Flex cotton must follow the same guidelines for establishing required refuge options, practicing IRM and managing target and non·target pests as described for Genuity'" Bollgard IF' cotton in the IRM/Grower Guide. WEED RESISTANCE MANAGEMENT GUIDELINES Follow all label requirements and the guidelines below to minimize the risk of developing weed resistance in a Genuity

.... Roundup Ready'" Flex cotton system:

o Scout fields before and after each burndown and

in-crop application.

o Start clean with a burndown herbicide program or tillage. • Use the right herbicide product at the right rate and right time.

MONSANTO ADundup BaUg:mlll ReadyFlllx

GENUITY'" BOLLGARD II' WITH ROUNDUP READY' FLEX COTTON Genuity'" Boligard W' with Roundup**Ready~** Flex varieties offer farmers the benefits of both insect protection and glyphosate tolerance combined in one crop. These varieties exhibit the same insect protection qualities as**Genuity!~** Bollgard 11'" and are tolerant to Dver-the-top applications of Roundup WeatherMAX'" and Roundup PowerMAX®.

o Add soil residual herbicide(s) and cultural practices as part of

aGenuity'" Roundup Ready® Flex cotton weed control program. • In-crop, apply Roundup WeatherMAX at a minimum of 22 oz/A

when weeds are 31t to 61t in height.

o Tank-mix other approved herbicides with Roundup WeatherMAX

If necessary for pastemergence weed control. • Should repeated non-performance occur, report to Monsanto or

your local retailer.

o Clean equipment before moving from field to field to minimize the

spread of weed seed (as well as nematodes, insects and other cotton pests). APPLICATION OF ROUNDUP WEATHERMAX' AND ROUNDUP POWERMAX' • May be applied over-the-top and/or in-crop, from crop emergence

up to7 days pr'lor to harvest.

o A maximum rate of 32 oz/A per application may be applied using

ground application equipment while the maximum is 22 ozlA per application by air.

o There are no growth or timing restrictions forsequential

applications. • Four (4) quarts/A is the total in-cropvolume allowed from

emergence to 60% open bolls. • A maximum total volume of 44oz/A may be applied between

layby and 60% open bolls. • Post-directed equipment may be used to achieve more thorough

spray coverage of weeds or if herbicides not labeled for overthe-top application will be tank-mixed with Roundup WeatherMAX or Roundup PowerMAX

.PREHARVEST APPLICATIONS • up to 44az/A may be applied after cotton reaches 60% open bolls

and before harvest, jf needed

. • Applications must be made at least 7 days prior to harvest.


### Over-The-Top (example) 22-32 az/A In any single application 

### Preharvest 440zfA 128 az/A total In-crop application (emergence to preharvest)

CROP SAFETY OF OVER-THE-TOP GLYPHOSATE APPLICATIONS Monsanto has determined that a combination of components in glyphosate formulations have the potential to cause leaf injury when applied during later stages of crop growth. Roundup WeatherMAX and Roundup PowerMAX are the only Roundup agricultural herbicides labeled and approved for new labeled uses overthe top of**Genuity'~** Roundup**Ready~** Flex cotton. Leaf injury may occur ifthe products are not used according to the product label. used at higher than recommended rates orifoverlap ofspray occurs in the field. Farmers must confirm that any glyphosate formulation to be used on**GenultyT~** Roundup Ready<!l Flex cotton has been labeled for use on**GenuityT~** Roundup Ready® Flex cotton and should confirm that it has been tested to demonstrate crop safety.

2010 TECHNOLOGY USE GUIDEWEED CONTROL RECOMMENDATIONS Weed control in cotton is essential to maximize both fiber yield and quality potential. Cotton is very sensitive to early-season weed competition, which can result in unacceptable stands and! or reduced yield potential. The Genuity'" Roundup**Ready~** Flex cotton system, with improved reproductive tolerance to Roundup® agricultural herbicides, provides farmers with the right tools to control weeds,

PROGRAM Preplant Burndown

Residual Herbicides**INSTRU~TIONS** AND USE RATES' Always start clean by planting into aweed-freefield using eithertillageoraburndown application. In no-till and reduced-till systems,applyapreplant burndownapplicationof Roundup WeatherMAX®" at22to44 oz/A in atank'mix with dicamba or2,4-D. See the dicamba and 2,4-D produd label for rates and time intervals required between application and cotton planting. State restridions may apply • ADDITIONAL INFORMATION Early-season weed competition can result in unacceptable stands andlorreducedyield potential. This tank-mix is recommended for control and management of glyphosate-resistant marestail (Conyzasp.) orothertoughto-control weeds. Burndown application should be made farenough in advance of planting tocontrol existing weeds.

.**-------~--.--.----** --- .**--------~-----.---** Apply approved residual herbicide(s) as part ofa Genuity'" Roundup Ready® Flex cottonweed control program, Use the recommended label rate and timing ofthe residual herbicideapplied. Referto individual product labelsfor list of residual herbicides that may be used

. The residual herbicide(s) may beapplied as either apreemergence (including preplant incorporated), pastemergence, andlorlayby application asallowed on the label ofthe specific product being used.

._-----------_._-_.- -- _._--------_._-_.

In-CropWeed Control Target the firstapplication of RoundupWeatherMAX on 1-2 leafcotton when weeds aresmall. Applya minimum of22 oz/A of Roundup WeatherMAX in-crop. The need forsequential applications of Roundup WeatherMAXwill depend upon the occurrence of subsequent weed flushes. Reierto the "Annual Weeds Rate Table" in the RoundupWeatherMAX label bookletfor rate recommendations forspecific annual weeds. Early-season weed competition can reduce yield potential in cotton. Seledtiming ofapplication based on the most difficult to control weed species in yourfield. Post-direct orhooded sprayerscan be used to achieve morethorough spraycoverage on weeds.

---_._-----_._--**~~-----------"----~-------"'---**

Preharvest Over-The-Top Applications

*Follow all pesticide label requirements. Before harvest and aftercotton reaches 60% open bolls, if needed, apply upto 44 oz/A of Roundup WeatherMAX. This treatmentis effectivein controlling late-season perennial weeds. Applications must be madeat least7days priorto harvest. Roundup agricultural herbicidesare noteffedive for preharvest cotton regrowth in Genuity" Roundup Ready®Flex cotton.

-*The maximum volume of Roundup WeatherMAX and Roundup**PowerMAX~** that may be used in asingle season 155.3 quarls per acre.

MONSANTORoundup**Ball~,rd!l** RoundupReadyFlex**Re~dy**Rex RECOMMENDATIONS FOR MANAGING GLYPHOSATE-RESISTANT WEEDS

Glyphosate-Resistant Marestail (Horseweed)

Glyphosate-Resistant AmaranthusSpecies**~** PalmerAmaranth

- Waterhemp

Glyphosate-Reslstant AmbrosiaSpeCies

- Giant Ragweed

- Common Ragweed

G

Iyphosate-Reslstant Jahnsangrass start clean with aburndown herbicide program ortillage. -Tank-mix Roundup agricultural herbicideswith dicamba or2,4-0 (consult label for plant backtiming). Ifyou have dense stands of marestail, useapreplant residual herbicide at the recommended rateand timing, such asdiuron (Direx@)orflumioxazin (Valo("'). Use RoundupWeatherMAX in-crop, as needed, at aminimum of22oi/A to control otherweeds, In-crop, ifapplying post-directed to glyphosate-resistant marestail. Roundup WeatherMAXcan be tank-mixed with other herbicides, such as diuron or MSMA. Marestail should notexceed 6" in height atthetime ofin-cropapplication. Startclean with aburndown herbicide program ortillage, Apply apreemergence residual herbicide such as pendimethalin (Prowl®) plus fluometuron orfomesafen (Reflex®) orflumioxazin (Valor) for control ofAmaranthusspecies. In'crop, tank'mix RoundupWeatherMAX at 22oi/Awith metolachloror other labeled chloracetamide herbicide before Amaranthu5species emerges. Use RoundupWeatherMAX in-crop, as needed, at aminimum of22oi/A to control otherweeds. Apost-directedapplication of Roundup WeatherMAX tank-mixed with MSMAand aresidual such as diuron (Direx) orflumioxazin (Valor) should be madeto control Amaranthusspecies 3" orsmallerin heightand prevent additional flushes. start clean with aburndown herbicide program orIillage. Apply apreemergence residual herbicide such as pendimethalin (Prowl) plus fluometuron orfomesafen (Reflex) forcontrol ofAmbrosiaspecies. In-crop, tank-mix Roundup WeatherMAX at22 oz/A with metolachlor before Ambrosiaspecies emerges. Use RoundupWeatherMAX in'crop, as needed, at aminimum of22oi/A to control otherweeds. Apost-directed application of Roundup WeatherMAX lank-mixed with MSMAand aresidual such as diuron (Direx) orflumioxazin (Valor)should be madeto control Ambrosiaspecies311 orsmaller in height and prevent additional flushes. start cleanwith aburndown herbicideortillage. Preplant incorporatearesidual herbicide such as pendimethalin ortrifluralin forcontrol orsuppression of seedling johnsongrass. Apply RoundupWeatherMAX in atank-mixwith herbicides such as SelectMAX"', Assure' II orPoast Plus for the control of emerged weeds including seedling and rhizomejohnsongrass. Follow all label directions oftank-mix partners, especially those relatedto weed size. In certainareas, Italianryegrass isknown to beresistantto glyphosate.Forcontrol recommendations, refertowww.weedresistancemanagement.com orcalil-BOO·768-63B7.Whenapproved,supplemental labeling forspecificherbicideproductscan also be viewedon www.cdms.netorwww.greenbook.net.

'Follow all pesticide label requirements.

2010 TECHNOLOGY USE GUIDE 

# IIFWundupReadyZ Yield 

### GenuityW Roundup Ready 2 Yield® and Roundup Ready® soybean 

### varieties contain in-plant tolerance to Roundup® agricultural herbicides. This means you can spray Roundup agricultural herbicides in-crop from emergence through flowering.

Spray labeled Roundup agricultural herbicides over the top from emergence (cracking) through flowering (R2 stage soybeans) WEED CONTROL RECOMMENDATIONS Starting clean with a**weed~free** field, and making timely**post~** emergence**in~crop** applications, is critical to obtaining excellent weed control and maximum yield potential. The Roundup Ready soybean system provides the flexibility to use the herbicide tools necessary to control weeds at planting and in-crop. Failure to control weeds with the right rate, at the right time and with the right product, can lead to increased weed competition and the potential for decreased yield. for unsurpassed weed control, proven crop safety and maximum yield potential. R2 stage soybeans end when apod 5 millimeters (3/1611 ) long at one ofthe four uppermost nodes appears on the main stem along with afully developed leaf (R3 stage).

PROGRAM Preplant Burndown

Residual Herbicide Plus Roundup WealherMAX INSTRUCTIONSAND USE RATES' To start clean in no-till systems. apply aburndown application of RoundupWeatherMAX®" at22 to44oziA before planting. See the label forappropriate rates by weed species. Forcontrol and management ofglyphosate-resistant marestail (Conyzasp.) or otherdifficult-to-controlweeds present at burndown. apply 22oziA of Roundup WeatherMAX inatank-mix with Ito 2ptiA 2,4-0. Makeapplications7to3D days before planting and before marestail reaches 6 11 in height. Use the recommended label rate of asoil-applied residual herbicide applied preemergencetosoybeans as defined in the individual product's labeling.The residual product may be tank-mixed with Roundup WeatherMAX at burndown. Referto individual product labels for list of residual herbicidesthat may be used, Follow with22 oziA Roundup WeatherMAX in-crop whenweeds are 2" to 8" tall. Referto the "Annual Weeds RateTable" in the RoundupWeatherMAX label for rate recommendations for specificannual weeds. Crop rotation following Genuity" Roundup Ready 2Yield®and Roundup Readysoybeans is strongly encouraged. Useofa residual herbicide is encouraged especiallyifthe cropping system is acontinuous Roundup Ready system, ADDITIONAL INFORMATION Always start with aweed-free field_In no-till and reduced-till systems, applyaRoundup WeatherMAX' burndown application to control existing weeds before planting. Adding 2,4-0 inthe burndown can significantly reduce broadleafweed pressure at post-emergence timing. Read the 2,4-0 product labelfortime intervals required between application and soybean planting.

-------- ---- Aresidual program is encouraged when agronomicconditions favorthe practice. Reducing RoundupWeatherMAX ratewhen tank-mixing with aresidual or useofpremixes utilizing areduced rate of glyphosate (such as Extreme·) is not recommended. Ifthe in-crop application is delayed and weeds are larger, apply a higher rate of Roundup WeatherMAX.

----------_.. _------- RoundupWealherMAX Apply aminimum of22 oziA of Roundup WeatherMAX" In-crop application of RoundupWeatherMAX provides control in-crop when weeds are 21(to 8 11 tall. of labeled weeds. Referto the "Annual Weeds RateTable" inthe Roundup For best results, apply3to 4weeks afterplanting or WeatherMAX label for rate recommendations forspecific when weedsare less than 8" tall. annual weeds. Choose the rateto control the most difficult- Ifinitial application is delayed and weedsare larger, to-control weed inyourfield. apply ahigherlabeled rate of Roundup WeatherMAX. Asequentialapplication ofthis product may be required to control newflushes ofweeds inthe Roundup Ready soybean crop. Ifasequential application is necessary, apply16to 22 oziA of Roundup WeatherMAX'" when weeds are3 11 to 6 11tall.

·Follow all pesticide label requirements. ._--_._---- Hlfusing another Roundup agricultural herbicide. you must refer tothe label booklet or**Genuity~** Roundup Ready 2**Yield~** soybean or Roundup Ready soybean supplemental label for that

brand to determine appropriate use rates, If using Roundup PowerMAX, application rales are the same as for Roundup WeatherMAX. 2010 TECHNOLOGY USE GUIDEPROGRAM Glyphosate-Tolerant VolunteerCOfn
Maximum Use Rates for Roundup WeatherMAX INSTRUCTIONS AND.USE RATES· Tank-mix Roundup WealherMAX·with 6to 12 oz/A of Select Max'and apply 10 4" to 36" glyphosale-Ioleranl volunteercorn. In-Crop: •44oz/A per single application •44oz/A during flowering •64 oz/A emergencethrough flowering (R2 slage soybeans) Preharvest: •22 oz/A application

-Follow all pesticide label requirements. ADDITIONAL INFORMATION Chooseyour Roundup WealherMAX rale based on the weed species and size lisled in Ihe "Annual Weeds RaleTable" ofthe Roundup WealherMAX Label.

------ Total Season: The combined lolal ofpreplanl, in'crop and preharvesl applications of Roundup WeatherMAX can nolexceed 5.3ql/A.The combined lolal ofin-crop and preharvesl applications can notexceed 64oz/A.

Herbicide products sold by Monsanto for use overthe top of soybeans with Genuity'" Roundup Ready 2 Yield'!) Technology for the 2010 crop season are as follows:
• Roundup WeatherMAX • Roundup PowerMAX

WEED CONTROL RECOMMENDATIONS

Weeds that Tend to Have Multiple Emergence Events Where dense stands ofweed species such as common lambsquarlers, lall and common walerhemp, Paimer Amaranth, redrool pigweed, common ragweed, and giant ragweed are expected, thefollowing agronomic practices are recommended:
•Start clean wilh tillage or burndown in no-IiII and reduced

till syslems, Include2,4'D in the burndown. •Plantsoybeans in narrow rows «20"). •Use apre'planl residual herbicide, •Use Ihe righl rale of Roundup WealherMAXal Ihe righl

time (properweed size). Weeds such as lambsquarters,waterhemp, pigweed, and giant ragweed lend 10 emergethroughout Ihe season. Sequential Roundup WeatherMAXapplicalions or Ihe addition ofasoil residual herbicide may be required forcontrol ofsubsequent weed flushes.

--- ._---_.._--_._--Difficult-toControl Weeds Black nightshade,velvetleaf, walerhemp, morningglory, lambsquarters, Florida pusley, giant ragweed, Pennsylvania smartweed, groundcherry, hemp sesbania and spurred anoda aredifficult'lo'conlrol weeds. Please referto the Roundup agricultural herbicide label forspecific rates and weed sizes for control ofthese weeds.

------------------

PerennialWeeds An in'cropapplicationof22 1044 oz/A of Roundup WeatherMAX" will providesuppression and/orconlrol of nutsedgeand perennial weeds likeCanada Ihistle, field bindweed, hempdogbane, horsenetile,johnsongrass, milkweed,quackgrass, etc. These weed species require speCial attention be paid 10 Roundup WealherMAX rale and application timing (properweed size) 10 oblain excellenl weed conlrol. A

sequential application may be required ifanew weed flush occurs, especiallyin soybeans planled in wide rows (>20"). Foradditional information on perennial weeds, see the "Perennial Weeds RateTable" inthe label booklet for Roundup WealherMAX_ Forbesl control. allow perennials 10 achieveal leasl 6" ormoreofgrowth before spraying.

--- *Follow all pesticide label requirements. **11 usinQ another Roundup agricu!lural herbicide, you must refer to the label booklat or Roundup Ready Soybean or**Genulty~** Roundup Ready 2**Yiald~** Soybean supplemental label forthat brand

todetermine appropriate use rates. If using Roundup PowerMAX, application rates are the same as for Roundup WealherMAX.

WEED RESISTANCE MANAGEMENT GUIDELINES Follow all pesticide label requirements and the guidelines below to minimize the risk of developing glyphosate-resistant weed

MONSANTO populations in a Roundup Ready Soybean System:
• Crop rotation is strongly encouraged. • Scout fields before and aftereach burndown and in-crop application.RaU!JlupRe:adyZYield

· Start clean with a burndown herbicide or tillage. • If an additional flush of weeds occurs, asequential application of Roundup WeatherMAX at 22 ozlA may be needed before weeds exceed 6" in height. - Tank-mix with 2,4-D to control glyphosate-resistant marestail or

othertough-to-control broadleafweeds. • Use the recommended label rate of asoil-applied residual herbicide

such as INTRRO®,**Valor~'.** Valor XLP' or Gangster"'. · Refer to individual product labels for a list of recommended tank-mix partners. • In-crop, apply Roundup WeatherMAX at aminimum of 22 ozlA

before weeds exceed 8 11 in height. • Clean equipment before moving from field to field to minimize the spread of weed seed. • Report repeated non-performance to Monsanto oryour local retailer. RECOMMENDATIONS FOR MANAGING GLVPHOSATE-RESISTANT WEEDS

Glyphosate-Resistant Marestail (Horseweed)

Glyphosate-Resistant AmaranthusSpecies

-PalmerAmaranth

- Waterhemp Preplant: Applya tank-mixture of22 o,IA Roundup WeatherMAX®with 1pI/A 2,4-0 before marestail exceeds 6" in height. See the 2,4-0 product label for time intervals required between application and planting_ In-crop: Itisstronglyencouraged that marestailshouldbecontrolled priorto planting using recommended preplantburndown treatments. In-crop,applyatank'mixture of22 o,IA RoundupWeatherMAXwithOJo,IA FirstRate®.Thistreatmentshould be used asasalvage treatmentonlyforamarestail infestationthatwas notcontrolled preplant.Application should be made betweenfull emergenceof the firsttrifoliate leafand 50%flowering stage ofsoybeans.Atthe timeoftreatment, marestailshould notexceed 6" inheight.**.~~~- ------~~** .. Preplant: Apply atank-mix of22 o,IA Roundup WeatherMAX with apreemergence residual herbicide such as alochlor(lNTRRO®), flumioxa,in (Valor®) oranother residual herbicidefor preemergencecontrol ofAmaranthusspecies.2,4-0 maybe added to the tank-mix to helpcontrol emerged Amaranthusspecies and otherbroadleafweeds preplant only. Follow label instructions regarding application timing relative to soybean planting. In-crop: It is strongly encouraged that apreemergence residual product be used to control Amaranthusspecies priorto emergence. Ifthere isemerged Amaranfhusin-crop, apply atank-mixture of22o,IA RoundupWeatherMAX with apostemergence product with activity on Amaranthussuch as lactofen (Cobra®), fomesafen (Flexstar®) or cloransulam (FirstRate).Applications should be made on emerged Amaranthusthat does not exceed 3" in height. Read and followall product label instructions. It is likelythat visual soybean injurywill occurwith these tank-mixtures. ----_ ...

_ .....**~~~~-.---.--** .....**~~** .---.. -...**--~-~.-----** ...**-~~~** Glyphosate-Resistant AmbrosiaSpeCies

- Giant Ragweed

- Common Ragweed Preplant: Apply atank-mix of22 o,IA RoundupWeatherMAX with apreemergence residual herbicide such as cloransulam (FirstRate) orcloransulam +flumioxazin (Ganster®) oranotherresidual herbicide for preemergence control of Ambrosiaspecies.2kD may be added to thetank·mix to help control emerged Ambrosiaspeciesand otherbroadleafweeds preplantonly. Follow label instructions regarding application timing relative tosoybean planting. In-crop: It is strongly encouraged that apreemergence residual product be used to control Ambrosiaspecies priorto emergence. Ifthere is emerged Ambrosiain·crop, apply atank·mixture of22o,IA Roundup WeatherMAX with apostemergence product with activity on Ambrosiasuch as lactofen (Cobra) orfomesafen (Flmtar), Applications should be made on emerged Ambrosiathat does not exceed 3" in height. Read and follow all product label instructions. It is likelythatvisual soybean injurywill occurwith these tank-mixtures,**----~---.-.~~~ -~~**  .-••.**-----~-~~-.---.------** Glyphosate-Resistant Johnsongrass Start clean with aburndown herbicide ortillage. Preplant incorporatearesidual herbicide such as pendimethalin ortrifluralin forcontrol orsuppression ofseedling johnsongrass. Apply Roundup WeatherMAX in atank·mixwith herbicides such as SelectMAX®, Assure" II orPoast Plus forthecontrol of emerged weeds including seedling and rhizomejohnsongrass. Follow all label directions oftank·mix partners, especiallythose related to weed size.**-.~--.----.-** ..**~~- ~~~-.~** ..**~-.--. ~~~".-**  ....**---~~~----~~-** Incertain areas, Italian ryegrass isknown to be resistanttoglyphosate. Forcontrol recommendations, refertowww.weedreslstancemanagement.com orcall 1-800-168-6387.Whenapproved,supplemental labeling forspecificherbicideproductscan also be viewedon www.cdms.netorwww.greenbook.net.

'Follow all pesticide label requirements, 2010 TECHNOLOGY USE GUIDERoundupReady Genuity'" Roundup Ready® alfalfa varieties have in-plant tolerance to Roundup® agricultural herbicides, enabling farmers to apply labeled Roundup agricultural herbicides up to 5 days before cutting for unsurpassed weed control, excellent crop safety and preservation of forage quality potential. 

### Hay and Forage Management Practices Genuity'" Roundup Ready!!> alfalfa must be managed for high quality hay/forage production, including timely cutting to promote high forage quality (i.e. before 10% bloom) and to prevent seed development. In geographies where conventional alfalfa seed production is intermingled with forage production and the agronomic conditions (climate and water/irrigation availability) are such thatforage alfalfa is allowed to stand and flower late in the season, Genuity'" Roundup Ready" alfalfa must be harvested at or before 10% bloom to minimize potential pollen flow from hay to common or conventional alfalfa seed production. Farmers who are unwill1ng to orwho can not make this commitment to stewardship should not continue to grow Genuity'" Roundup ReadylO alfalfa. Genuity'" Roundup**Ready~** alfalfa varieties have excellent toleranceto over-the-top applications of labeled Roundup agricultural herbicides. An in-crop weed control program using Roundup WeatherMAXs or Roundup**PowerMAX~** will provide excellent weed control in mostsituations. A residual herbicide labeled for use in alfalfa may also be applied postemergence in alfalfa. Contact a Monsanto Representative, local crop advisor or extension specialist to determinethe best option for your situation. 

### Stand Takeout and Volunteer Management Crop rotations can be divided into two main groups, alfalfa rotated to: 1) grass crops (e.g. corn and cereal crops); and 2) broadleaf crops. More herbicide alternatives exist for management ofvolunteeralfalfa in grass crops. The recommended steps for controlling volunteer Genuity'" Roundup Ready'" alfalfa are:

• Diligent StandTakeout • Plan for Success • Start Clean •Timely Execution DILIGENT STAND TAKEOUT Use appropriate, commercially available herbicide treatments alone for reduced tillage systems or in combination with tillage to terminate the Genuity'" Roundup Ready/; alfalfa stand. Refer to your regional technical bulletin forspecificstand takeout recommendations. NOTE: Roundup'" agricultural herbicides are not effectivefor terminating Genuity'· Roundup Ready);) alfalfa stands. START CLEAN If necessary, utilize tillage and/or additional herbicide application(s) after stand takeout, and before planting of the subsequent rotational crop to manage any newly emerged or surviving alfalfa. PLAN FOR SUCCESS Rotate the crops with known and available mechanical or herbicidal methods for managing volunteer alfalfa, keeping in mind that Roundup agricultural herbicides will not terminate Genuity'" Roundup**Ready~** alfalfa stands.
• Rotations to certain broadleaf crops are not advisable if

the farmer is notwilling to Implement recommended stand termination practices. • In the event that no known mechanical or herbicidal methods

are available to manage volunteer alfalfa in the desired rotational crop, it is suggested that a crop with established volunteer alfalfa management practices be introduced intothe rotation. TIMELY EXECUTION Implement in-crop mechanical or herbicide treatments for managing alfalfa volunteers in atimely manner; that is, before the volunteers become too large to control or begin to compete with the rotational crop
.

2010 TECHNOLOGY USE GUIDE

### Planting Requirements GenuityT>< Roundup**Ready'~** alfalfa is not permitted to be planted in any wildlife feed plots. 

### Stewardship All Genuity'" Roundup Ready!> alfalfa farmers shall sign the Monsanto Technology/Stewardship Agreement (MTSA) limiteduse license application which provides the terms and conditions forthe authorized use of the product. Due to special circumstances, alfalfa farmers in the Imperial Valley of California will also sign an Imperial Valley Use Agreement (IVUA) with specific stewardship commitments. The MTSA Of IVUA must be completed before purchase or use ofseed. Both the MTSA or IVUA explicitly prohibit all forms of commercia! seed harvest on the stand. Every alfalfa farmer producing seed ofGenuity'" Roundup Ready'" alfalfa must possess an additional, separate and distinctseed farmercontract to produce Genuity'" Roundup Ready" alfalfa seed. Genuity'" Roundup Ready'" alfalfa seed may not be planted outside of the United States, or for the production ofseed orsprouts. Any product produced from a Genuity"" Roundup Ready® alfalfa crop or seed, including hay and hay products, must be labeled and may only be used, exported to, processed orsold in countries where regulatory approvals have been granted. It is aviolation of national and international laws to move material containing biotech traits across boundaries into nationswhere import is not permitted. Pursuant toa Court Order issued on May 3, 2007, Genuity"" Roundup ReadyiE' alfalfa farmers must adhere to the requirements set out in the December18, 2007 USDA Administrative Order (http://www.aphis.usda.qov/brs/pdf/RRA_AB_final.pdi) until the USDA completes its regulatory process. These requirements include, but are not limited to:
• Pollinators shall not be added to Genuity'" Roundup Ready1fi

alfalfa fields grown only for hay production. • Farm equipment used in Genuity'" Roundup Ready'" alfalfa

production shall be properly cleaned after use. • Genuity" Roundup Ready!! alfalfa shall be handled and clearly

Identified to minimize commingling after harvest. For additional information visit the USDA website: http://www.aphls.usda.qov/blotechnoloqy/alfalfa_hlstory.shtml For more information and the latest updates on Genuity'" Roundup Ready" alfalfa, go to http://www.roundupreadyalfalfa.com

To meet sales reporting requirements, the seed supplier is required to identify and list all Genuity'M Roundup Ready® alfalfa field locations. Therefore, all farmers MUST PROVIDE their seed supplierwith the GPS coordinates of all their Genuity'M Roundup Ready® alfalfa fields.

MONSANTOWEED RESISTANCE MANAGEMENT GUIDELINES Follow all pesticide label requirements and the guidelines below to minimize the risk of developing glyphosate-resistant weed populations in a**GenuityT~** Roundup Ready:;' alfalfa system:
• Scout fields before and after each herbicide application. • Use the right herbicide product atthe right rate and at

the right time.

WEED CDNTROL RECDMMENDATIONS In established stands, to preserve the quality potential of forage and hay, applications should be made afterweeds have emerged

PROGRAM Eslablished Siands

Weeds Conlrolled

Maximum Use Rales INSTRUCTIONS AND USE RATES' Afterthefirst harvest ofanewlyestablished stand, up to 44oz/A of RoundupWeatherMAX®** herbicide percutting may be applied upto 5days before each subsequentcutting.The combined total peryearfor aU in-crop applications in establishedstands must not exceed 132 oz/A(4.1 qt/A)ofRoundupWeatherMAX. Forspecific application rates and instructionsfor control ofvarious annual and perennial weeds, referto Ihe RoundupWealherMAX" herbicide label booklet. Someweeds with multiple germination times or suppressed (stunted)weeds may require asecond application of RoundupWeatherMAX** herbicidefor complete control. Forsome perennialweeds, repeated applications may be required to eliminate crop competitionthroughoutthe growing season. In-Crop: •44oz/A persingle application.
•Established Stand Tolal: 44oz/A percutting

upto 5days before harvest

*Follow all pestlcide label requirements. RDundup Ready

• To control flushes ofweeds in established alfalfa, make

applications of Roundup WeatherMAX'!J or Roundup PowerMAXZ, herbicide at 22 to 44az/A before weeds exceed 6" in height. up to 5 days before cutting. • Use other approved herbicide products tank-mixed or in

sequence with Roundup agricultural herbicide if appropriate for the weed spectrum present as part of a Genuity'" Roundup**Ready~** alfalfa weed control program. • Report repeated non·performance to Monsanto or your

local retailer.

but before alfalfa re·growth interferes with application spray coverage of the target weeds.

ADDITIONAL INFORMATION Applications between cuttings may be applied as asingle application or in multiple applications (e.g.2applications of22oz/A). Sequential applications should be at least7days apart.

In additionto thoseweeds listed inthe RoundupWeatherMAX* label booklets, this productwill suppress orcontrolthe parasiticweed, dodder (Cuscutaspp.) in Genuity'" Roundup Ready®alfalfa. Repeatapplications may be necessaryfor complete control. Fortough·to·controlweeds orweeds notcontrolled by Roundup®agricultural herbicides use labeled rates of otherapproved herbicides, alone orin tank-mixtures, with Roundup agricultural herbicides.

Tolal PerYear: The combined total per yearforall in-cropapplications in established stands must notexceed 132oz/A (4.1qt/A)01 RoundupWealherMAX

.

"If using another Roundup agricultural herbicide,you must refer to the label booklet orseparately published**Genuity~** Roundup**Ready~** alfalfa supplemental label

for that brand to determineappropriate use rates. If usIng Roundup PowerMAX, appllcallon rates are the same as for Roundup WeatherMAX.

2010 TECHNOLOGY USE GUIDERoundup**R~ady** N 

# Genuity'M Roundup Ready" spring canola hybrids contain in-plant tolerance to Roundup agricultural herbicides, enablingfarmersto apply Roundup0 

# agricultural herbicides over the top of GenuityTM Roundup Ready6 

# spring canola anytime from emergence through the 6-leaf stage of development.

The introduction of the Roundup Ready'" trait into leading spring canola hybrids and varieties gives farmers the opportunity for unsurpassed weed control, proven crop safety and maximum profit potential. With Genuitv''' Roundup Ready®spring canola, farmers have the weed management tool necessary to improve spring canola profitability, while providing aviable rotational crop to help break pest and disease cycles in cereal-growing areas. WEED RESISTANCE MANAGEMENT GUIDELINES Follow all pesticide label requirements and the guidelines below to minimize the risk ofdeveloping glyphosate-resistant weed populations in a Genuity'" Roundup Ready!> spring canola system:

WEED CONTROL RECOMMENDATIONS (SPRING-SEEDED)

PROGRAM Two·Pass ProgramForAnnual and Perennial Weed Control

Single AppllcationForAnnual Weed Control

Maximum Use Rate For Roundup WeatherMAX INSTRUCTIONSAND USE RATES' For broad'spectrumcontrol of annual and perennial weeds, usean initial application0111

### oz/Aof Roundup WeatherMAX", in 5to 10 gallAwatervolume. No surfactantis required. Make asecond application of11

### oz/A of Roundup WeatherMAX" no lessthan 10days afterinitial application up to the6-leafstage (prebolting). Do not exceed 11

### oz/A perapplication.

Forbroad-spectrum control ofannual and easy-to-control perennial weeds, make asingle application of16

### oz/A of Roundup WeatherMAX."

Twoover-the-topapplications: Do notexceed 11

### oz/A perapplication. Single over-the-top applications: Do notexceed 16 

### oz/A_No additional application can be made.

"Follow all pesticide label requirements. • Scout fields before and after each burndown and in-crop application. • Start clean with a burndown herbicide ortillage. • In-crop, apply Roundup WeatherMAXn herbicide before

weeds exceed 3" in height. • A sequential application of Roundup weatherMAX herbicide

may be needed. • Clean equipment before moving from field to field to minimize

the spread of weed seed. • Report repeated non-performance to Monsanto oryour local

retailer.

ADDITIONAL INFORMATION Spraywhencanola is at the 0-to 6-leafstage ofgrowth.To maximize yield potential, spray Genuity' Roundup Ready· spring canola atthe 1-to 3-leaf stage to eliminate competing weeds. Short-term yellowing mayoccurwith laterapplications,with littleeliee!on cropgrowth,maturity,oryield. Wait aminimumof10days between applications.Two applications of Roundup WeatherMAX will:
•Control lateflushes ofannual weeds such as foxtail, pigweed,

andwild mustard. •Provide season-long suppression of Canadathistle, quackgrass, and

perennial sowthistle. •Provide betteryields byeliminating competition from both annuals

and hard-la-control perennials. For best results, spray Genuity' Roundup Ready®spring canola at the2- to 3-leafstage_Can be applied up to6-leafstage;yellowing may occur with laterapplication with littleeffee!on crop growth, maturity,oryield, No additional over-the-top applications can be made,

··If using another Roundup agricultural herbicide. you must refer tothe label booklet or separately published Genuity'" Roundup Ready'" canola supplemental label for that brand to determine

appropriate use rales. If using Roundup PowerMAX. applicat"lon rates arethe same as for Roundup WeatherMAX. MONSANTO

## , GenuityTM Roundup Ready® winter canola varieties have been developed for seeding in the fall and harvesting the following spring/summer. RoundupReady Genuity'" Roundup Readyfl winter canola varieties contain in-plant tolerance to Roundupnagricultural herbicides, enabling farmers to apply Roundup agricultural herbicides over the top ofGenulty-" Roundup ReadyB winter canola from crop emergence tothe pre-bolting stage. The introduction of the Roundup Ready trait into winter canola varieties gives farmers the opportunity of unsurpassed weed control, crop safety and maximum yield potentia!. Genuity'" Roundup Ready'!! winter canola offers farmers an important option as a rotational crop in traditional monoculture winter wheat production areas. Introducing crap rotation is an important factor in reducing pest cycles, including weed and disease problems. WEED RESISTANCE MANAGEMENT GUIDELINES Follow the same guidelines as stated forspring canola.

WEED CONTROL RECOMMENDATIONS (WINTER-SEEDED)

PROGRAM INSTRUCTIONS AND.USE RATES· Sequential Applications Thetwo-pass program gives the greatest flexibility in controlling lateemergingweeds. Forbroad'spectrumweed control,apply11to22 oz/Aof RoundupWeatherMAX" herbicideto2-leaforlarger Genuity"Roundup Ready'])winter canola in thefall. Use 5to 10 galionslA watervolume, Do not add surfactants.

Single Application

Maximum Use Ratefor Roundup WeatherMAX Applyasecond application of RoundupWeatherMAX** at11to 22 oz/A ataminimum interval of60 daysafterthe first application and before bolting in the spring. Do notexceed 22oz/A perapplication. For broad-spectrum control ofannual and easy-to-control perennial weeds, make asingle application of16to 22 oz/A of RoundupWeatherMAX", preferably in the fall.

---------------------- Anysingle over-the-topapplication of Roundup WeatherMAX" should not exceed22

### oz/A_Nomorethan two over-thE-top applications may be made from crop emergenceto canopyclosure priorto bolting in the spring. ADDITIONAL INFORMATION Spraywhen Genuity' Roundup Ready·wintercanola is at the 2-3 leafstage ofgrowth, Earlyapplications can eliminate competing weeds and improve yield potential. Two applicalions of Roundup WeatherMAX will provide control of earlyemerging annual weeds and winter emerging weeds such as downy brome, cheat andjoinled goalgrass.

Forbesl results, spray Genuitv' Roundup Ready·wintercanola allhe2-3 leafstage andwhen weeds aresmall and actively growing_Applicalions must be made priorto bolting_Usethe higherrale in the rangewhen weed densitiesare high, when weeds have overwintered orwhenweeds become large and well established_

--_._--------------------------- Applications ofgrealerIhan16fluid ounceslA prior 10 Ihe6-leaf stage may resull in temporary yellowing andlorgrowth reduclion,

----------------- "Follow all pesticide label requirements. ulfusing another Roundup brand herbicide, you must refer\0the label booktet orGenuity'" Roundup Ready" winter canola supptemental label for that brand to determine

appropriate use rates. Ifusing Roundup PowerMAX. application rates are the same as for Roundup WeatherMAX.
GRAZING It is recommended that**Genuity'~** Roundup Ready!') winter canola not be grazed. While Genuity'" Roundup ReadyGl wintercanola may provide farmers additional opportunity as a forage for grazing livestock, at the presenttime insufficient information exists to allow safe and proper grazing recommendations. Preliminary data suggest that excessive grazing can significantly reduce yield, and that careful nitrate management is critical in managing Genuity'" Roundup ReadylP winter canola as aforage to limit the risk of livestock nitrate poisoning. State universities are assessing the potential and the instructions for grazing Genuity'" Roundup Ready"" winter canola and they will provide grazing management guidelines when their research is completed.

2010 TECHNOLOGY USE GUIDE 

# I'

# Genuity'" Roundup Ready® sugarbeet varieties have

Roundup Ready 

# in-plant tolerance to Roundup" agricultural herbicides, enabling farmers to apply labeled Roundup agricultural herbicides from planting through 30 days prior to harvest for unsurpassed weed preservation of yield potential.

MANAGEMENT PRACTICES Sugarbeets are extremelysensitive to weed competition for light. nutrients and soil moisture. Research on sugarbeet weed control suggests that sugarbeets need to be kept weed-free for the first eight weeks of growth to protect yield potential.Therefore, weeds must be controlled when they are small and before they compete with Genuity"'Roundup Ready® sugarbeets (exceed crop height), that is from less than 2" up to411 in height, to preserve sugarbeet yield potential. More than one in-crop herbicide application willbe requiredto control weed infestations to protect yield potential as Roundup agricultural herbicides have no soil residual activity. Bolting sugarbeets must be rogued or topped in Genuity'M Roundup Ready® sugarbeet fields. Genuity"" Roundup Ready® sugarbeetvarieties have excellent tolerance to over-the-top applications of labeled Roundup agricultural herbicides. A postemergence weed control program using Roundup WeatherMAX,]l or Roundup PowerMAX'.ID will provide excellent weed control in most situations. A residual herbicide labeled for use in sugarbeets may also be applied preemergence, preplant or postemergence in Genuity"" Roundup Ready® sugarbeets. Contact a Monsanto Representative, local crop advisor orextension specialist to determinethe best option for yoursituation. WEED RESISTANCE MANAGEMENT FOR GENUITY'" ROUNDUP READY® SUGARBEETS Follow all pesticide label requirements and the guidelines below to minimize the risk of developing glyphosate-resistantweed populations in a Genuity'" Roundup Ready® sugarbeet system:
• Start clean with tillage and follow-up with a burndown

herbicide, such as Roundup WeatherMAX, if needed prior to planting. • Early-season weed control is critical to protect sugarbeet

yield potential. Apply the first In-crop application of Roundup WeatherMAX at aminimum of22 ozlA while weeds are less than 21t in height. 

# III MONSANTO 

# control, excellent crop safety and

• Follow with additional postemergence in-crop application of

Roundup WeatherMAX at aminimum of22 oz/A for additional weed flushes before weeds exceed 4" in height. • Add spray grade ammonium sulfate at a rate of 17 Ibs/100 gallons

ofspray solution with Roundup'!> agricultural herbicides to maximize product performance. • Use mechanical weed control/cultivation andlor residual

herbicides where appropriate in your Genuity'" Roundup Ready® sugarbeets. • Use additional herbicide modes of action/residual herbicides

and/or mechanical weed control In other Roundup Ready crops you rotate with Genuity'· Roundup Ready'!) sugarbeets. • Report repeated non-performance of Roundup agricultural

herbicides to Monsanto or your local retailer. AGRONOMIC PRINCIPLES IN SUGARBEETS Sugarbeets are very sensitive to early-season weed competition. It is important toselect the appropriate herbicide product, application rate and timing to minimize weed competition to protect yields. The Genuity'· Roundup Ready® sugarbeet system provides a mechanism to control weeds at planting and once Genuity·· Roundup Ready® sugarbeets emerge. Failure to control weeds with the right rate, at the right time and with the right product, can lead to increased weed competition, weed escapes and the potential for decreased yields. Tank-mixtures of Roundup agricultural herbicides with fungicides, insecticides, micronutrients or foliar fertilizers are not recommended as they may result in crop injury and reduced pest control orantagonism. PLANTING REQUIREMENTS Genuity'· Roundup Ready® sugarbeets are not permitted to be planted in anywildlife reed plots, STEWARDSHIP All Genuity'M Roundup Ready® sugarbeet farmers shall sign the Monsanto Technology/Stewardship Agreement (MTSA) limiteduse license application which provides the terms and conditions for the authorized use of the product. The MTSA must be signed and approved prior to purchase or use ofseed.WEED CONTROL RECOMMENDATIONS

PROGRAM Preplant Burndown

Over-The-Top Applications up to eight-leafGenuity" Roundup Ready· Sugarbeets

Over-The-Top Applications to greaterthan eight-leafGenuity' Roundup Ready· Sugarbeets

Maximum Use Rates INSTRUCTIONS AND USE RATES' Afterpreplanttillage orbedding operations have been completed,a preplant burndown application ofRoundupWealherMAX®** at22to 44az/Amaybe appliedtocontrol weedsthat havegerminatedafter tillage and priorto planting. Seethe labelforappropriate rates byweed species andweedsize. Uptotwo applications of Roundup agricultural herbicides maybe made priortotheS-IeafstageofGenuity'" Roundup Ready®sugarbeets. Thefirst application of22to32az/Aof RoundupWealherMAX** should be madewhenweedsare lessthan211 in heightto protect yield potential. Makean additional application of22to 32oz/Aof RoundupWeatherMAX beforeweeds exceed4 11 in height. Maximum in-crop RoundupWeatherMAX priorto a-leafstage must not exceed56oz/A.
Up to two additional applications of22 oz/A of Roundup WeatherMAX can be madeafterthe eight-leafstage up to 30 days priorto harvest. Maximum in-crop Roundup WeatherMAX from a-leafstage up until 30 days priorto harvest must notexceed 44adA.

In-Crop: "Two applications of RoundupWeatherMAX priortothe a-leafstage

ofGenuity" Roundup Ready®sugarbeets

-32oz/A persingle application uptothe a-leafstage.

-Combined maximum of56oz/Ain-crop priortothe a-leafstage "Two applications of RoundupWeatherMAXafterthe a-leafstage

up to 30days priorto harvest

-22oz/A persingle application afterthe a-leafstage.

-Combined maximumof44az/A in-cropafterthe a-leafstage

until 30days priorto harvest

"Follow all pesticide label requirements. ADDITIONAL INFORMATION Always utilizetillagetostartwith aweed-freefield.

Sugarbeetsare sensitivetoweed competition and can loseyield rapidly ifweedsare notcontrolled early. Morethan one in-crop RoundupWeatherMAXapplicationwill be required to controlweed infestationsto protectyield potential as Roundup agricultural herbicides have nosoil residual activity. Addammonium sulfate atarate of 171bs/lOOgallonsofspray solutionwith Roundupagricultural herbicidesto maximize product performance.Tank-mixtures ofRoundup agricultural herbicideswithfungicides, insecticides, micronutrientsorfoliar fertilizers are not recommended. Sequentialapplicationsshould beat least10daysapart Add ammonium sulfate atarate of 171bs/100gallons ofspraysolution with Roundup agricultural herbicidesto maximize product performance.Tank-mixtures of Roundup agricultural herbicideswith fungicides, insecticides, micronutrientsorfoliarfertilizers are not recommended. Sequentialapplications should be at least 10days apart. Total PerYear: The combinedtotal peryearforall RoundupWeatherMAX applications including pre-plant must notexceed 5.3 qt/A. Total in-cropapplication must notexceed 3qUA. Add ammonium sulfate atarate of171bs/iOOgallonsofspray solutionwith Roundup agricultural herbicides to maximize product performance.Tank-mixtures of Roundup agricultural herbicides with fungicides, insecticides, micronutrients orfoliar fertilizers are not recommended.

**Ifusing another Roundup agricultural herbicide,you must refer to the labe! booklet orseparately published**Genuity~** Roundup**Ready~** 5ugarbeets supplemental label for

that brand todetermine appropriate use rates. If using Roundup PowerMAX, application rates are Ihesame as for Roundup WealherMAX.

2010 TECHNOLOGY USE GUIDEThis guide was printed using Utopia II XG Cover " Saves the equivalent of 585 mature trees Reduces solid waste by 35,308 pounds Reduces waste water by 213,390 gallons and Text which contains 30% post·consumer waste. Savings derived from using 30% post-consumer fiber in lieu of100%virgin fibers: Reduces greenhouse gas emissions by 199,989.75 pounds

Before opening a bag of seed, be sure to read, understand and accept the stewardship requirements, Including applicable refuge requirements for Insect resistance management, for the biotechnology tralts expressed in the seed as set forth In the MonsantoTechnology Agreement that you sign. By opening and using a bag ofseed, you are reaffirming your obligation to Plut16,lWQu, hrurrfll,rHbJ/ffl' comply withthe most recent stewardship requirements. 

### LIBERTY 

### LlNK"1!7

..................................

Roundup Ready" Alfalfa seed Is currently not for sale ordlstrlbutron.The movement and use of Roundup Ready" Alfa[fa forage [s subject to a USDA admlnlstrOltive Orderavailable at http://www.aph[s.usda.govJbrsJpdIJRRA_AB_flnal.pdf. ThIs stewardshipstatement applies to all products listed herein except Genulty"" VT Double PROTM, GenultyTM VT TrIple PRO'" and Genulty"" SmartStax,.... See restrIctions related to Genulty"" Double PROTM, Genulty'" VTTriple PRO'" and Genulty'" SmartStax'" below: Monsanto Company is a**m~mber** of**Exc~lIence** Through Stewardship" lETS). Monsanto products are commercialized in accordancewith ETS Product Launch Stewardship Guidance. and In compliance with Monsanto's Policy for Commercialization of Blotechnology'Derlved Plant Products in CommodityCrops. This product has been approved for Import Into key**e~port** markets with functioning regulatory systems. Any crop or material produced from this product can only be exported to, or used, processed orsold in countries where all necessary regulatory approvals have been granled.1I is a violalfon of national and internallonallaw to move material containing biotech traits across boundaries into nations where Import Is not permitted. Growers should talk to theIr grain handleror product purchaserto confirm theIr buying posilfon for this product. Excellence Through**Stewardship~** is a registered trademark of Biotechnology Industry Organization. IMPORTANT: Grain Marketing and Seed Availability: Genulty"" VT Double PRO'" has received the necessary approvals in the United States, however, as ofOctober22, 2009,approvals have not been received in certain majorcorn export markets.**Genulty~** VT Double PRO'" will not be launched and seed will notbe available until afler import approvals are received In appropriate majorcorn**e~port** markets. B.t. products, including**Genuity~** VT Double PRO'u may not yet be registered in all states. Check with your Monsanlo representative for the registration slatus in yourstate. IMPORTANT: Grain Marketing and**Se~d** Availability: Genulty'" VT Triple PRO"" has received the necessary approvals In the UnitedStales however, as of October22, 2009, approval has not been received in all majorcorn export markets. Monsantoanticipates that all such approvals will be in place for the 2010 growing season. If all approvals are not in place, Genulty'U VT Triple PRO'"seed will only be avallable as partofa commercial demonstration program that Includes grain markeling stewardship requirements. Itis aviolation 01 nationaland international lawto move material containing biolechtraitsacross boundaries into nationswhere import is not permitted. Consult with your seed representative for current regulatory and stewardship informationstatus. IMPORTANT: GraIn Marketrng and Seed AvaUabillty: Genulty'" SmartStax'" has received the necessary approvals in the United States, however, as ofOctober22, 2009,approvals have notbeen received in certain major corn export markets. Genulty'" Smartstax'" wlll not be launched and seed wilt not be available until after Import approvals are rece!ved inappropriate majorcorn export markets. B.t. products, includIng Genulty""SmartStax'" may not yet be registered in all states, Check withyour Monsanto representative forthe registration slatus In yourstate.**Cottonse~d** contaIning Monsanto traits may not be**export~d** for**th~** purpose of planting without a license from Monsanto. Indlvldua[ results may vary, and performance may vary from locationto locationand from year to year. This result may notbe an indicatorof results you mayobtain as local growing, soil and weather condilions mayvary. Growers should evaluate data from multiple locations and years whenever possible. Growers may utilize the natural refuge optron forvarieties containingthe Boligard II'" trait Inthe following states: AL. AR, FL, GA, KS, KY, LA, MD, MS, MO, NC, OK, SC, TN, VA, and most ofTexas (excluding IheTexas counties of Brewster, Crane, Crockell, Culberson, EI Paso, Hudspeth,Jeff Davis, Loving, Pecos, Presidio, Reeves, Terrell. Val Verde, Ward and Winkler). The natural refuge optiondoes notapply to Bollgard II callan grown In areas where pink bollworm is a pest, including CA. AZ, NM, and the above listedTexas counUes. Italso remains the case Ihat**BoUgard~** and Boligard II cotlon cannot be planled south of HIghway 60 in Florida, and that Boligardcotlon cannol be planted in certain othercounties in the Texas panhandle. Referto the Technology Use Guide and IRM/Grower Guide for additional information regarding Bongard II, Bollgard, natural refuge and EPA'mandated geographical restricHons on the planting of B.t. colton. ALWAYS READ AND FOLLOW PESTiCIDE LABEL DIRECTIONS. Roundup Ready'" crops contain genes thai confertolerance to glyphosale, the acl!ve ingredient in Roundup" brand agricultural herbicides. Roundup? brand agricultural herbicideswill kill crops that are nottolerantto glyphosate.**Degree~** and**Harness~** are 1'101 registered in all slates. Degree" and Harness'" may be subject to use restrictions in some states. Bullet\ Degree Xlra', Harness",**INTRRO~, Larlat~,**  and Micro-Tech-. are reslricled use pesticides and are not registered inall states.The distribution,sale, or use of an unregistered pesticide is aviolation of federal and/orstate law and is strictly prohiblled,Check with your local Monsanlodealer or representativeforthe product regIstration status In yourSlate. Tank mIxtures:The applicable labeling loreach product must be in the possession of the userat the lime of application. Follow applicable use instructions, IncludIng application rates, precaullons and restrictions ofeach product used inthetank mixture, Monsanto has not tested all tank mix product formulations for compatibility or performance otherthanspecifically listed by brand name. Always predetermine the compatibilityof tank mIxtures by mixing small proportional quantities inadvance. Boligard", Boligard II", Bullet"**Degree~,** Degree Xtra",**Genuity~,** Genuity and**Design~,** Genuity Icons,**Harness~.INTRRO~, Laria!~,** **Micro'Tech~,** Respect the Refuge and Cotton**De5Ign~, Roundup~,**  Roundup**PowerMAX~,** Roundup Ready", Roundup Ready 2 Technology and**Design~,** Roundup Ready 2**Yieid~,** Roundup Ready**RATE~.** Roundup**WeatherMAX~,** Roundup WeatherMAX and Design', SmartStax", SmartSlax and**Design~,** Slart Clean, Stay Clean."', Transorb and**Design~,** Vistlve"', Vistive and Design", VT Double**PRO~.** VT Triple**PRO~, YieldGard~,**  YieldGard Corn Borer and Design", YieldGard Plus and Design", YieldGard Rootworm and**Design~.** YieldGard VP', YieldGard VT and Design", YleldGard VT Rootworm/RR2", YieldGard VT Triple", and Monsanto and Vine**Design~** are trademarks of MonsantoTechnology**LLC.lgnite~** and UbertyUnkY andthe Water Droplet Design"are registered trademarks of Bayer. Herculex Is a trademark of Dow AgroSciences LLC. Select**Ma~'~** and Valor" are registered trademarks of Valent U.S.A. Corporation. Respecl the Refuge'" and Respect the Refuge and Corn Design" are registered trademarks of National Corn Growers Association. All other trademarks arethe propertyof theIr respective owners. ©2009 Monsanto Company. {19282Apgd]SA-9Y-09-3B81